Biological Products: Complex pharmaceutical substances, preparations, or matter derived from organisms usually obtained by biological methods or assay.Legislation, Drug: Laws concerned with manufacturing, dispensing, and marketing of drugs.Pharmaceutic Aids: Substances which are of little or no therapeutic value, but are necessary in the manufacture, compounding, storage, etc., of pharmaceutical preparations or drug dosage forms. They include SOLVENTS, diluting agents, and suspending agents, and emulsifying agents. Also, ANTIOXIDANTS; PRESERVATIVES, PHARMACEUTICAL; COLORING AGENTS; FLAVORING AGENTS; VEHICLES; EXCIPIENTS; OINTMENT BASES.United States Food and Drug Administration: An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.Investigational New Drug Application: An application that must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans. This application includes results of previous experiments; how, where, and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in animal studies; and how the compound is manufactured. (From the "New Medicines in Development" Series produced by the Pharmaceutical Manufacturers Association and published irregularly.)Pestivirus Infections: Infections with viruses of the genus PESTIVIRUS, family FLAVIVIRIDAE.Drug Contamination: The presence of organisms, or any foreign material that makes a drug preparation impure.Preservation, Biological: The process of protecting various samples of biological material.Drug Approval: Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.Drug Labeling: Use of written, printed, or graphic materials upon or accompanying a drug container or wrapper. It includes contents, indications, effects, dosages, routes, methods, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions, and other relevant information.Consumer Product SafetyPreservatives, Pharmaceutical: Substances added to pharmaceutical preparations to protect them from chemical change or microbial action. They include ANTI-BACTERIAL AGENTS and antioxidants.Drugs, Investigational: Drugs which have received FDA approval for human testing but have yet to be approved for commercial marketing. This includes drugs used for treatment while they still are undergoing clinical trials (Treatment IND). The main heading includes drugs under investigation in foreign countries.Drug Industry: That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.Safety: Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.Quality Control: A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)Pharmaceutical Preparations: Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.Guidelines as Topic: A systematic statement of policy rules or principles. Guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by convening expert panels. The text may be cursive or in outline form but is generally a comprehensive guide to problems and approaches in any field of activity. For guidelines in the field of health care and clinical medicine, PRACTICE GUIDELINES AS TOPIC is available.Chemistry, Pharmaceutical: Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use.United StatesModels, Biological: Theoretical representations that simulate the behavior or activity of biological processes or diseases. For disease models in living animals, DISEASE MODELS, ANIMAL is available. Biological models include the use of mathematical equations, computers, and other electronic equipment.Molecular Sequence Data: Descriptions of specific amino acid, carbohydrate, or nucleotide sequences which have appeared in the published literature and/or are deposited in and maintained by databanks such as GENBANK, European Molecular Biology Laboratory (EMBL), National Biomedical Research Foundation (NBRF), or other sequence repositories.Amino Acid Sequence: The order of amino acids as they occur in a polypeptide chain. This is referred to as the primary structure of proteins. It is of fundamental importance in determining PROTEIN CONFORMATION.Base Sequence: The sequence of PURINES and PYRIMIDINES in nucleic acids and polynucleotides. It is also called nucleotide sequence.Biological Assay: A method of measuring the effects of a biologically active substance using an intermediate in vivo or in vitro tissue or cell model under controlled conditions. It includes virulence studies in animal fetuses in utero, mouse convulsion bioassay of insulin, quantitation of tumor-initiator systems in mouse skin, calculation of potentiating effects of a hormonal factor in an isolated strip of contracting stomach muscle, etc.Biological Therapy: Treatment of diseases with biological materials or biological response modifiers, such as the use of GENES; CELLS; TISSUES; organs; SERUM; VACCINES; and humoral agents.

Changes of neonatal mortality rate between 'pre' and 'post' surfactant period. (1/1706)

The objective of this study was to determine how the neonatal mortality rate has changed since surfactant (S) therapy was introduced in our Neonatal Intensive Care Unit (NICU), and to evaluate the efficacy of surfactant therapy in respiratory distress syndrome (RDS) patients. Incidences of risk babies such as outborns, prematurity, low birth weight infants and RDS, and neonatal mortality rates were compared between 'pre' (control, 1988 to 1991, n=4,861) and 'post' S period (study, 1993 to 1996, n=5,430). In RDS patients of 'post' S period, neonatal mortality rate was compared between S-treated and non-treated patients, and chest X-ray and ventilatory parameters were compared between pre- and post-72 hr of surfactant treatment. Surfactant therapy showed short term effects, judging by the decrease of early neonatal deaths and improvement of chest X-ray and ventilatory parameters in RDS patients. The overall neonatal mortality rate had a tendency to decrease in spite of increased incidences of risk babies in 'post' S period but it was less than expected. The reasons were thought to be that we had a high proportion of risk babies, and there was some bias in patient selection for surfactant therapy and its use. In conclusion, with the active prevention of risk baby delivery and appropriate use of surfactant, better results could be expected.  (+info)

Surfactant treatment for acute respiratory distress syndrome. (2/1706)

OBJECTIVE: To determine prospectively the efficacy of surfactant in acute respiratory distress syndrome. STUDY DESIGN: Twenty patients, 1 month to 16 years of age, diagnosed with an acute pulmonary disease with severe hypoxaemia (PaO2/FiO2 < 100) (13 with systemic or pulmonary disease and seven with cardiac disease) were treated with one to six doses of 50-200 mg/kg of porcine surfactant administered directly into the trachea. The surfactant was considered to be effective when the PaO2/FiO2 improved by > 20%. RESULTS: After initial surfactant administration the PaO2/FiO2 increased significantly in patients with systemic or pulmonary disease from 68 to 111, and the oxygenation index (OI) diminished significantly from 36.9 to 27.1. The PaO2/FiO2 and OI did not improve in children with cardiac disease. The improvement of the patients who survived was greater than that of those who died. CONCLUSIONS: Surfactant moderately improves oxygenation in some children with severe acute respiratory distress syndrome secondary to pulmonary or systemic disease.  (+info)

Preclinical development strategies for novel gene therapeutic products. (3/1706)

With over 220 investigational new drug applications currently active, gene therapy represents one of the fastest growing areas in biotherapeutic research. Initially conceived for replacing defective genes in diseases such as cystic fibrosis or inborn errors of metabolism with genes encoding the normal, or wild-type, gene product, gene therapy has expanded into other novel applications such as treatment of cancer or cardiovascular disease, where the risk:benefit profiles may be more acceptable in relation to the severity of the disease. Different types of vectors, including modified retroviruses, adenoviruses, adenovirus-associated viruses, and herpesviruses and plasmid DNA, are used to transfer foreign genetic material into patients' cells or tissues. Developing a toxicology program to determine the safety of these agents, therefore, requires a modified approach that encompasses the pharmacology and toxicity of both the gene product itself and the vector system used for delivery in the context of the application for the clinical trial. In general, the issues involved in designing and developing appropriate preclinical testing to determine the safety of these products are similar to those encountered for other recombinant molecules, including protein biotherapeutics. Limitations to some of the typical toxicology studies conducted for a traditional drug development program may exist for these agents, and nontraditional approaches may be required to demonstrate their safety. Many factors may affect the safety and clinical activity of these agents, including the route, frequency, and duration of exposure and the type of vector employed. Other safety considerations include quantitation of the duration and degree of expression of the vector in target and other tissues, the effects of gene expression on organ pathology and/or histology, evaluation of trafficking of gene-transduced cells or vector after injection, and interactions of the host immune system with the transduced cell population. Because of the unique concerns regarding each of these therapies, the Center for Biologics Evaluation and Research encourages sponsors to obtain toxicity data whenever possible while evaluating the pharmacologic activity of the vector in a species or animal model relevant to their clinical indication. Sponsors are encouraged to discuss preclinical study design and results with the Center during product development to facilitate early identification of safety concerns prior to entry of these novel agents into the clinical setting and to ensure an uninterrupted course of development while addressing issues required for licensure.  (+info)

Regulatory decision strategy for entry of a novel biological therapeutic with a clinically unmonitorable toxicity into clinical trials: pre-IND meetings and a case example. (4/1706)

The following material was derived from a synthesis of case histories taken from investigational new drug (IND) applications and drug sponsors' experiences, utilizing fictionalized data to avoid any resemblance to any proprietary information; any such resemblance is accidental. These examples are used as an instructional scenario to illustrate appropriate handling of a difficult toxicology issue. In this scenario, a drug caused a toxicity in animals that was detected only by histopathologic analysis; if it were to develop in patients, no conventional clinical methods could be identified to monitor for it. It is not unusual for a firm to cancel clinical development plans for a lead drug candidate that causes such a toxicity, especially if such a drug is intended for use as a chronic therapeutic in a population of patients with a chronic disease. This case synthesis was inspired by a Food and Drug Administration (FDA) agreement to allow such a product to proceed into clinical trials after substantive pre-IND discussions and agreement on well-considered toxicology program designs. The scientists most closely involved in the strategy development included the sponsor's toxicologist, veterinary toxicologic pathologist, and pharmacokineticist, as well as the FDA's reviewing pharmacologist. The basis of this decision was thorough toxicity characterization (1-month studies in 2 species); correlating toxicities with a particular cumulative area under the curve (AUC) in both species; identification of the most sensitive species (the species that showed the lower AUC correlating with toxicity); allometric assessment of clearance of the drug in 3 nonhuman species; construction of a model of human kinetics (based on extrapolation from animal kinetics); and finally, estimation of clinical safety factors (ratios of the human estimated cumulative AUC at the proposed clinical doses, over the animal cumulative AUC that correlated with the no adverse effect levels). Industry and FDA scientists negotiated a joint assessment of risk and benefit in patients, resulting in the FDA permitting such a compound to enter into clinical trials for a serious autoimmune disease. Such constructive, early communication starts with the pre-IND meeting, and the conduct and planning for this meeting can be very important in establishing smooth scientific and regulatory groundwork for the future of a drug under IND investigation.  (+info)

Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond. (5/1706)

Many scientific discussions, especially in the past 8 yr, have focused on definition of criteria for the optimal assessment of the preclinical toxicity of pharmaceuticals. With the current overlap of responsibility among centers within the Food and Drug Administration (FDA), uniformity of testing standards, when appropriate, would be desirable. These discussions have extended beyond the boundaries of the FDA and have culminated in the acceptance of formalized, internationally recognized guidances. The work of the International Committee on Harmonisation (ICH) and the initiatives developed by the FDA are important because they (a) represent a consensus scientific opinion, (b) promote consistency, (c) improve the quality of the studies performed, (d) assist the public sector in determining what may be generally acceptable to prepare product development plans, and (e) provide guidance for the sponsors in the design of preclinical toxicity studies. Disadvantages associated with such initiatives include (a) the establishment of a historical database that is difficult to relinquish, (b) the promotion of a check-the-box approach, i.e., a tendancy to perform only the minimum evaluation required by the guidelines, (c) the creation of a disincentive for industry to develop and validate new models, and (d) the creation of state-of-the-art guidances that may not allow for appropriate evaluation of novel therapies. The introduction of biotechnology-derived pharmaceuticals for clinical use has often required the application of unique approaches to assessing their safety in preclinical studies. There is much diversity among these products, which include the gene and cellular therapies, monoclonal antibodies, human-derived recombinant regulatory proteins, blood products, and vaccines. For many of the biological therapies, there will be unique product issues that may require specific modifications to protocol design and may raise additional safety concerns (e.g., immunogenicity). Guidances concerning the design of preclinical studies for such therapies are generally based on the clinical indication. Risk versus benefit decisions are made with an understanding of the nature of the patient population, the severity of disease, and the availability of alternative therapies. Key components of protocol design for preclinical studies addressing the risks of these agents include (a) a safe starting dose in humans, (b) identification of potential target organs, (c) identification of clinical parameters that should be monitored in humans, and (d) identification of at-risk populations. One of the distinct aspects of the safety evaluation of biotechnology-derived pharmaceuticals is the use of relevant and often nontraditional species and the use of animal models of disease in preclinical safety evaluation. Extensive contributions were made by the Center for Biologics Evaluation and Research to the ICH document on the safety of biotherapeutics, which is intended to provide worldwide guidance for a framework approach to the design and review of preclinical programs. Rational, scientifically sound study design and early identification of the potential safety concerns that may be anticipated in the clinical trial can result in preclinical data that facilitate use of these novel therapies for use in humans without duplication of effort or the unnecessary use of animals.  (+info)

Are there environmental forms of systemic autoimmune diseases? (6/1706)

A large number of drugs and an increasing number of environmental agents reportedly result in the appearance of a number of autoantibodies and in many instances in the appearance of a range of autoimmune clinical syndromes. The major disorders so recognized have marked resemblances to the autoimmune disease systemic lupus erythematosus. The commonly used term is drug-induced lupus; a better term is drug-related lupus. There is considerable interest at the present time in an increasing number of environmental agents. There have been two epidemics in recent years--one in Spain to a contaminant of rapeseed oil and one in the United States to a contaminant of l-tryptophan that caused an eosinophilic myositis. It is important for physicians and others involved in health care to recognize the potential associations of these diseases of unknown cause or causes.  (+info)

The role of the toxicologic pathologist in the preclinical safety evaluation of biotechnology-derived pharmaceuticals. (7/1706)

Biotechnology-derived pharmaceuticals, or biopharmaceuticals, represent a special class of complex, high molecular weight products, such as monoclonal antibodies, recombinant proteins, and nucleic acids. With these compounds, it is not appropriate to follow conventional safety testing programs, and the preclinical "package" for each biopharmaceutical needs to be individually designed. In addition to standard histopathology, the use of molecular pathology techniques is often required either in conventional animal studies or in in vitro tests. In this review, the safety evaluation of biopharmaceuticals is discussed from the perspective of the toxicologic pathologist, and appropriate examples are given of the use of molecular pathology procedures. Examples include the use of in situ hybridization to localize gene therapy vectors, the assessment of vector integration into genomic DNA by the polymerase chain reaction (PCR), and the use of immunohistochemistry to evaluate the potential cross-reactivity of monoclonal antibodies. In situ PCR techniques may allow for confirmation of the germ cell localization of nucleic acids and may therefore facilitate the risk assessment of germline transmission. Increased involvement with biopharmaceuticals will present challenging opportunities for the toxicologic pathologist and will allow for much greater use of molecular techniques, which have a critical role in the preclinical development of these compounds.  (+info)

Structures of surfactant films: a scanning force microscopy study. (8/1706)

The alveolar lining layer is thought to consist of a continuous duplex layer, i.e., an aqueous hypophase covered by a thin surfactant film which is a monolayer with dipalmitoyl-phosphatidylcholine (DPPC) as its most important component. Findings obtained by electron microscopy and results from in vitro experiments suggest, however, that the structure and hence the structure-function relations of surfactant films are more complex. In order to better define their structures films of surfactants were studied by scanning force microscopy. Four different surfactants were spread on a Langmuir-Wilhelmy balance, and then transferred onto a solid mica plate by the Langmuir-Blodgett technique, under various states of film compression. Imaging of the films by scanning force microscopy was performed in the contact (repulsive) mode in air. The scanning force micrographs revealed that surfactant films are not homogeneous, but rather undergo phase transitions depending on the surface pressures. Even at comparable surface pressures different surfactants show quite different surface patterns. Differences in surface structure can even be observed in films containing surfactant proteins (SP)-B and SP-C. These observations give further evidence that the widely accepted hypothesis of a regular monolayer of phospholipids governing the surface tension probably does not hold true, but that the structure-function relationship of surface active surfactant films is even more complex than hitherto thought.  (+info)

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Title:Natural Product-Derived Spirooxindole Fragments Serve as Privileged Substructures for Discovery of New Anticancer Agents. VOLUME: 16 ISSUE: 10. Author(s):Bin Yu, Yi-Chao Zheng, Xiao-Jing Shi, Ping-Ping Qi and Hong-Min Liu. Affiliation:School of Pharmaceutical Sciences and New Drug Research & Development Center, Zhengzhou University, Zhengzhou 450001, P. R. China.. Keywords:Anticancer agents, cancer therapy, MDM2 inhibitors, natural products, PLK4 inhibitors, spirooxindoles.. Abstract:The utility of natural products for identifying anticancer agents has been highly pursued in the last decades and over 100 drug molecules in clinic are natural products or natural product-derived compounds. Natural products are believed to be able to cover unexplored chemical space that is normally not occupied by commercially available molecule libraries. However, the low abundance and synthetic intractability of natural products have limited their applications in drug discovery. Recently, the identification ...
Pharmaceutical manufacturer Merck will donate its entire library of natural products to the Institute for Hepatitis and Virus Research along with a grant, the institute announced this week. The library, one of the worlds largest, will be open for researchers around the world.. "This is an extraordinary opportunity for the Hepatitis B Foundation and our research institute, allowing us to make this treasure available to scientists from all over the world," Timothy Block, co-founder and president of the Hepatitis B Foundation and the IHVR, said in a press release. Block is also a professor of microbiology at Drexel University College of Medicine. The institute is located in Pennsylvania.. "We will be able to create a screening center and provide access to this collection in a way that may lead to new discoveries and new companies in both Pennsylvania and New Jersey," he said.. The Merck (also known as MSD) natural products library is considered to be "one of the most diverse and best curated ...
Researchers at UCLA wondered whether red yeast rice might also be useful for preventing cancer. We know that lovastatin decreases blood cholesterol, but it also has an anti-inflammation effect, and inflammation is a primary risk factor in colon cancer development, explains Mee Young Hong, MD, who was a research fellow in the UCLA Center for Human Nutrition when she worked on the study, and is now assistant professor at San Diego State University. We thought that red yeast rice, which contains a natural source of lovastatin, might help with cancer prevention. Past research has found that cancerous tumors need cholesterol to grow, and studies have shown that people who take statins have a reduced risk of colon cancer.. Dr. Hong and her colleagues compared the effects of different Chinese red yeast rice formulations with the drug lovastatin on colon cancer cells in a laboratory.* The red yeast rice triggered tumor cell death, and it reduced tumor cell growth by as much as 41%--an even greater ...
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KALAMAZOO--Dr. Gunda I. Georg, an expert in medicinal chemistry, drug discovery and natural products chemistry, will deliver the 2012 Harmon Lecture at Western Michigan University from 4 to 5:15 p.m. Monday, April 9, in Room 1260 of the Chemistry Building.. Georg will address "Natural Products as Leads for Anticancer Drug Discovery." The U.S. Food and Drug Administration has approved more than 1,000 new small molecule drugs in the past 30 years. Of the approved anticancer agents, 74 percent are natural product-derived. Thus, natural products continue to be an excellent source as drugs or leads for drug discovery efforts.. A reception will follow the lecture, which is open to the public free of charge.. Tuesday, April 10, from 11 a.m. to 12:15 p.m., Georg will speak on "The Evolving Landscape for Drug Discovery Innovation," also in Room 1260 of the Chemistry Building. The second talk will provide an overview of the health care challenges in the future, including increases in world population, ...
The discovery of new antibiotics reached its peak during the golden era of antibiotics in the mid 20th century and continued to thrive until the 1980s. However, after more than 50 years of fruitful exploration and exploitation of microbial natural products the discovery rate of new antibiotics has dropped drastically in recent decades. On the other hand, known compounds were re-discovered again and again, possibly from related producing organisms, making natural products discovery an expensive and time-consuming endeavor. Therefore, in recent years, efforts for discovering new natural products have been redirected towards organisms from unique and untapped areas of the globe with remarkable biodiversity potential and/or extreme environment, such as deep-sea vents, caves, and other unusual ecosystems. This dissertation describes our efforts to discover new bioactive natural products from microorganisms isolated from a unique black water ecosystem in Indonesia. Indonesia is recognized as a major ...
Thus, alternatives to the statins are often sought by people experiencing negative side effects. It should be noted that a recent study published in the Annals of Internal Medicine do support the use of red yeast rice, actually a by-product of cooked rice on which red yeast is grown. The study found that red yeast rice in supplement form was effective in patients who had been unable to take statin drugs because the drugs caused muscle problems. The study also found that that red yeast rice did not cause liver impairment (Garloch, 2010 ...
Link for Professor OConnor. Abstract: Plants, which make thousands of complex natural products, are outstanding chemists. Through the concerted action of enzymes that are assembled into metabolic pathways, nature creates chemical complexity from simple starting materials. I will highlight some of the unusual enzymatic transformations that plants use to make complex, bioactive natural products, and will also discuss methods by which these pathways can be harnessed for metabolic engineering. The focus is on the biosynthesis of the monoterpenes called iridoids, and the alkaloids derived from iridoids, known as the monoterpene indole alkaloids. The discovery, functional characterization and mechanistic study of enzymes involved in the biosynthesis of these important compounds in several medicinal plant species will be discussed.. ...
Beyond Red Yeast Rice 60 Tablets Directions: As a dietary supplement, take 2 tablets daily, preferably with meals. Store in a cool, dry place. Caution: Do not take if you are pregnant or nursing. This product is not to be used by anyone under 20 years of age. Consult with your physician before using this product if you are taking any medication or if you are under physician supervision. Description:Red Yeast Rice contains beneficial unsaturated fatty acids (>125 mg/g) including mono- and polyunsaturated fatty acids, as well as proteins, amino acids and phytonutrients. All are elements of a healthy diet.Artichoke extract has flavonoid constituents that demonstrate antioxidant activity and are intended to provide nutritional support for healthy digestion.Guggul, a plant that has been used in traditional Ayurvedic medicine for centuries, is intended to provide nutritional support for healthy cardiac enzymes and heart function.Vitamin B-12, B6, and Folic Acid have been added and are intended to
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Covering up to February 2015 Phenylglycine-type amino acids occur in a wide variety of peptide natural products, including glycopeptide antibiotics and biologically active linear and cyclic peptides. Sequencing of biosynthesis gene clusters of chloroeremomycin, balhimycin and pristinamycin paved the wa
Historically, natural products have been used since ancient times and in folklore for the treatment of many diseases and illnesses. Classical natural product chemistry methodologies enabled a vast array of bioactive secondary metabolites from terrestrial and marine sources to be discovered. Many of these natural products have gone on to become current drug candidates. This brief review aims to highlight historically significant bioactive marine and terrestrial natural products, their use in folklore and dereplication techniques to rapidly facilitate their discovery. Furthermore a discussion of how natural product chemistry has resulted in the identification of many drug candidates; the application of advanced hyphenated spectroscopic techniques to aid in their discovery, the future of natural product chemistry and finally adopting metabolomic profiling and dereplication approaches for the comprehensive study of natural product extracts will be discussed.
The predatory marine gastropod Dicathais orbita has been the subject of a significant amount of biological and chemical research over the past five decades. Natural products research on D. orbita includes the isolation and identification of brominated indoles and choline esters as precursors of Tyrian purple, as well as the synthesis of structural analogues, bioactivity testing, biodistributional and biosynthetic studies. Here I also report on how well these compounds conform to Lipinskis rule of five for druglikeness and their predicted receptor binding and enzyme inhibitor activity. The composition of mycosporine-like amino acids, fatty acids and sterols has also been described in the egg masses of D. orbita. The combination of bioactive compounds produced by D. orbita is of interest for further studies in chemical ecology, as well as for future nutraceutical development. Biological insights into the life history of this species, as well as ongoing research on the gene expression, microbial symbionts
NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: New Methodologies for Natural Products Chemistry (R01) RFA-RM-09-005. Roadmap
Peers Alley Media Invites Experts and Performers to Participate at Natural Product Chemistry Conferences. The event will welcome more than 300+ attendees from Europe, USA, Asia, Middle East, Canada,Japan and Australia.
The marine habitat represents an untapped source of bioactive compounds with promising therapeutic potential and clinical applications. As a result of intensive bioprospecting efforts in the search of bioactive secondary metabolites from the marine environment, during the last decade there has been a considerable increase in the number of marine natural products that have been successfully launched into the drug market (i.e., Yondelis®, Adcertis®, Halaven®). In addition, numerous potential marine-derived drug candidates are currently in advanced stages of clinical development. This has partly been driven by advances in sampling and analytical techniques as well as by novel high-throughput screening platform technologies. Nevertheless, the limited supply of promising bioactive metabolites from their natural sources remains one of the major bottlenecks in marine natural products drug discovery and development.As an alternative to the environmentally unsustainable wild harvesting, marine invertebrate
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Plant natural product research can be facilitated through genome and transcriptome sequencing approaches that generate informative sequence and expression datasets that enable characterization of biochemical pathways of interest. As the overwhelming majority of plant-derived natural products are derived from Modern Methods in Plant Natural Products
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This study will divide into two groups, single and multiple doses groups. In single dose group, the subjects will receive one, two and four red yeast rice capsules under fed state in period one to three, respectively. In multiple doses group, the subjects will receive red yeast rice capsules under fed state twice daily for 4.5 days. There is a minimum of a 5-days washout period before crossover of treatments.. In single dose treatment, the blood samples will be drawn prior to the dosing, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the dosing.. In multiple doses treatment, the blood samples will be drawn prior to the 1st dosing, prior to the 7th dosing, prior to the 8th dosing, prior to the 9th dosing, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the 9th dosing. ...
Red yeast rice vs niacin to lower cholesterol - I am 34 years old, 365 pds, I take niacin, red yeast rice and fish oil, for high cholesterol, hbp at what age should I consider a asprian regimen? Probably 50. Because of your age, your risk is still on the low side, so instead of starting aspirin, you should do your best to lose weight. I know I am not offering groundbreaking news to you, but often we discount the most important thing that we can do and look for the esoteric. A 34 year old non-diabetic, does not need to be on aspirin, you need to lose weight, no matter what length youd have to go to.
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Highlights DOI: 10.1002/anie.200803868 Biosynthesis Extending the Biosynthetic Repertoire in Ribosomal Peptide Assembly Bradley S. Moore* bacteriocins · biosynthesis · enzymes · natural products · ribosomal peptides Natural products are quite inspiring. To chemists, they inspire the development of new synthetic methods and the creation of ever more sensitive analytical techniques. Biologists, on the other hand, exploit natural products in the discovery of new molecular targets and drugs, as well as to learn more about the way cells or whole organisms communicate with each other. Natural products also motivate biochemists to explore new ways in which nature assembles complex organic molecules. Such products, in one form or another, have helped transform modern science. In this post-genomic era, the scientific field of natural product biosynthesis has witnessed a constant flow of fascinating discoveries outlining new biochemical transformations in secondary metabolism. Most recently, cyclic ...
... -Milk Thistle & Alpha Lipoic AcidSupports Liver Function*A Dietary SupplementVegetarian/VeganRed Yeast Rice (RYR) is a natural product that has been used by Asian traditional herbalists for
The report, titled Ortho Biological Products is an in-depth analysis of the Ortho Biological Products market across the world. A brief historic overview of the Ortho Biological Products market has been mentioned in the report, followed by the present scenario of the market. The report analyses the size of the market and forecasts the valuation and the growth rate of the market in the span of next couple of years. Key drivers and restraints of the overall market has been pointed out. The report cites the various opportunities to favor the growth of the Ortho Biological Products market during the forecast period. It also indicates the key market trends shaping up the market.. The Ortho Biological Products market has certain distinct aspects. The report throws light on each of these aspects and studies the various segments of the market in detail. The growth of each of the market segments during the forecast horizon has been analyzed in the report. The present state of the Chinese economy has ...
Continuous Mechanical Extract Brochures on Specification Building Product Library, view and download brochures to your desktop, tablet or smart phone.
This topic has 35 study abstracts on Red Yeast Rice indicating that it may have therapeutic value in the treatment of Hyperlipidemia, Triglycerides: Elevated, and Mortality: All-Cause
Shop for H.P.F Cholestene 600Mg Dietary Supplement Capsules With Red Yeast Rice - 120 Capsules from Heart Health. Browse other items form Cholestene Dietary Supplement
Another popular cholesterol-lowering supplement is red yeast rice. There is some evidence that red yeast rice can help lower your LDL cholesterol. However, the Food and Drug Administration has warned that red yeast rice products could contain a naturally occurring form of the prescription medication known as lovastatin.. Lovastatin in red yeast rice products is potentially dangerous because theres no way to know how much lovastatin might be in a particular product. And theres no way to determine the quality of the lovastatin. ...
Searching for the high quality red yeast rice extract powder/ 1.5% lovastatin? Here we are. Longfu Biochemical is one of the leading herbal products manufacturers with wide expertise and experience. Welcome to wholesale the factory supply hot sale products from us.
Someone posted a link to an article that mentioned the FDAs banning of red yeast rice because it naturally contains lovastatin. I did some research and it irked me to no end. Okay, heres the synopsis of the development: It has been used in Chinese medicine since at least 800 A.D. for various purposes and to remove blood blockages. Some American pharmaceutical company gets ahold of this stuff and extracts the specific chemical that lowers cholesterol, goes through the FDA, its
Get the highest quality of apothecary products today from Smallflower. Come check out our HeartSure Red Yeast Rice + Phytosterols (60).
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Helpful, trusted answers from doctors: Dr. Manuel on red yeast rice side effects: Ryr can cause abdominal pain, allergic reaction, dizziness, liver and muscle inflammation with muscular pain, flatulance (gas), stomach pain, and headache. Aside from flushing, Niacin can cause liver damage, itching, low blood pressure, upset stomach, diarrhea, vomiting, gout, rashes, headache, diabetes, liver inflammation, and blurred vision.
Red yeast rice is fermented rice with a bright reddish purple color. The color is a result of being cultivated with the moldMonascusPurpureus. The rice itself
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uses the highest quality, 100% organic, GMO-free, non-irradiated Red Yeast Rice, along with odorless Aged Garlic Extractâ„¢, from organic raw garlic, plus CoQ10, a synergistic combination to provide unique benefits
A Moderate Drug Interaction exists between lovastatin and red yeast rice. View detailed information regarding this drug interaction.
Bioprospecting is an effective way to find novel enzymes from strains with desirable phenotypes. Such bioprospecting has enabled organisms such as Saccharomyces cerevisiae to utilize nonnative pentose sugars. Yet, the efficiency of this pentose catabolism (especially for the case of arabinose) remains suboptimal. Thus, further pathway optimization or identification of novel, optimal pathways is needed. Previously, we identified a novel set of xylan catabolic pathway enzymes from a superior pentose-utilizing strain of Ustilago bevomyces. These enzymes were used to successfully engineer a xylan-utilizing S. cerevisiae through a blended approach of bioprospecting and evolutionary engineering. Here, we expanded this approach to xylose and arabinose catabolic pathway engineering and demonstrated that bioprospected xylose and arabinose catabolic pathways from U. bevomyces offer alternative choices for enabling efficient pentose catabolism in S. cerevisiae. By introducing a novel set of xylose ...
Natural products have been a rich source of compounds with structural and chemical diversity for drug discovery. However, antibiotic resistance in bacteria has been reported for nearly every antibiotic once it is used in clinical practice. In the past decade, pharmaceutical companies have reduced their natural product discovery projects because of challenges, such as high costs, low return rates, and high rediscovery rates. The largely unexplored marine environment harbours substantial diversity and is a large resource to discover novel compounds with novel modes of action, which is essential for the treatment of drug-resistant bacterial infections. In this Review, we report compounds derived from marine sources that have shown in-vivo and in-vitro efficacy against drug-resistant bacteria. Analysis of the physicochemical properties of these marine natural products with activity against drug-resistant bacteria showed that 60% of the compounds have oral bioavailability potential. Their overall ...
Early cultures used specific products to cure specific diseases. Chances are that the ancient Egyptians had no idea that the Vitamin A in ox liver was what cured nyctalopia, but liver was used as a cure for this disease. In ancient Mesopotamia, Egypt and other countries, a wide variety of plants, animal products and even stones were used as treatments for various ailments. These cures were discovered by trial and error (Porter, 1997).. As early as 800 AD, the Benedictine monks were using many natural medicines, including the poppy (Papaver somniferum), which was used to alleviate pain as well as an anaesthetic. The active ingredient, morphine, was only extracted in 1806… almost 1000 years later. It was marketed by Merck in 1826. Many other natural products such as quinine, which was the only effective anti-malarial at the time, were also isolated in the nineteenth century (Grabley & Thiericke, 1999). However, these drugs were also characterised largely by random experimentation, and many other ...
I am a research scientist and an educator associated with Oregon State University and Lane Community College. My primary use of the ToL website is to help educate and train college-level non-biology majors in the field of evolutionary biology and genetics. I think that evolution theory is one of the most grand and unifying theories in biology that lends insight into so many different areas of biology. My educational background is as follows: 1. Research Assistant Professor, Natural Products Research, College of Pharmacy, Oregon State University 2004-present. 2. Postdoctoral Fellow, Marine Natural Products Research, College of Pharmacy, Oregon State University 2000 - 2003. Ph.D. in Biochemistry, Vanderbilt University, Nashville, TN. 1994-2000. Master of Science in Ecology, University of Denver, Denver, CO. 1992-1994. Bachelor of Science in Biology at University of Denver, Denver, CO. Minors in Chemistry and Geography. 1988-1992. My main research interests are in learning how microorganisms ...
Hi There, Swanson Health Products has issued a statement regarding the FDA letter sent about their red yeast rice products:. The FDA notified Swanson Health Products that we cannot sell our current red yeast rice formulations, and therefore we have pulled the products from sale. Lovastatin is a naturally occurring component of red yeast rice; however, the FDA has taken issue with the level of lovastatin that is in our products based on their testing. The products will be reformulated and returned to our shelves as soon as possible.. For years Swanson Health Products has far exceeded the quality assurance standards set by the federal government for dietary supplements. Since 2001, weve participated in the GMP (Good Manufacturing Practices) program of the Natural Products Association, and we have consistently received their "A" rating for our compliance to it. Swanson Health Products is committed to complying with all laws and regulations pertaining to our products. Swanson Health Products is ...
The policies and regulations contained in this online University of Mississippi Catalog are in effect for the current or selected semester. The catalog is not a contract, but rather a guide for the convenience of students. The University of Mississippi reserves the right to 1) change or withdraw courses; 2) change the fees, rules, and schedules for admission, registration, instruction, and graduation; and 3) change other regulations affecting the student body at any time. Implicit in each students enrollment with the university is an agreement to comply with university rules and regulations, which the university may modify to exercise properly its educational responsibility ...
Agbo J. B. P. A. A., Mpetga J. D.S., Tchuenguem R. T., Tsafack R. B. N., Awouafack M. D., Dzoyem J. P., Ito T., Bikanga R., Morita H., Tane P ...
Natural Product Genomics. Demuris is applying advanced genomic techniques to its own in-house natural product drug discovery programmes. Demuris can perform:. ...
Baker, J.T., Borris, R.P., Carté, B., Cordell, G.A., Cragg, G.M., Gupta, M.P., Iwu, M.M., Madulid, D.R. & Tyler, V.E. 1995. Natural product drug discovery and development: new perspectives on international collaboration. Journal of Natural Products 58:(9) 1325-1357. Bhatia, S. & A. Kothari, A. 1996. Community register for documenting local uses of biological diversity. Bulletin of the Working Group on Traditional Resource Rights 2: 9-10. Counsel, S. & Rice, T. eds. 1992. The Rainforest Harvest: Sustainable Strategies for Saving the Tropical Forests: Proceedings of and International Conference Held at the Royal Geographical Society. London: Friends of the Earth. Dutfield, G. 1993. Conservation of the Tropical Forests and the Pharmaceutical Industry. Unpublished MPhil dissertation. Cambridge, Department of Geography, University of Cambridge. Dutfield, G. 1994. Report on the Fourth Congress of Ethnobiology. Oxford, UK; Working Group on Traditional Resource Rights. Dutfield, G. & Ghate, U. 1997. ...
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Dr. Robison spent 10 years at Millennium Pharmaceuticals working with various genomics & proteomics technologies & working on multiple teams attempting to apply these throughout the drug discovery process. He spent 2 years at Codon Devices working on a variety of protein & metabolic engineering projects as well as monitoring a high-throughput gene synthesis facility. After a brief bit of consulting, he rejoined the cancer drug discovery field at Infinity Pharmaceuticals in May 2009. In September 2011 he joined Warp Drive Bio, a startup applying genomics to natural product drug discovery. Other recurring characters in this blog are his loyal Shih Tzu Amanda and his teenaged son alias TNG (The Next Generation). Dr. Robison can be reached via his Gmail account, [email protected] You can also follow him on Twitter as @OmicsOmicsBlog ...
Dr. Robison spent 10 years at Millennium Pharmaceuticals working with various genomics & proteomics technologies & working on multiple teams attempting to apply these throughout the drug discovery process. He spent 2 years at Codon Devices working on a variety of protein & metabolic engineering projects as well as monitoring a high-throughput gene synthesis facility. After a brief bit of consulting, he rejoined the cancer drug discovery field at Infinity Pharmaceuticals in May 2009. In September 2011 he joined Warp Drive Bio, a startup applying genomics to natural product drug discovery. Other recurring characters in this blog are his loyal Shih Tzu Amanda and his teenaged son alias TNG (The Next Generation). Dr. Robison can be reached via his Gmail account, [email protected] You can also follow him on Twitter as @OmicsOmicsBlog ...
Tannia Lau. Research Lab: Scott Lokey. Department: Chemistry & Biochemistry. Research Description:. We are performing imaged based cytological profiling high-throughput screenings that allows you to screen drugs in a 384 well format. We use this approach to analyze cellular phenotypes (nuclei, cytoskeleton, microtubules, ER, Golgi, S-phase, and mitotic markers) induced by chemical compounds. We can compare these phenotypes to a mechanism of action reference library. Then quantify these features using a multivariate statistical analysis platform based on organelle intensity, size, shape, and absence/presence, etc... We aim to approach natural product drug discovery by classifying bioactive compounds based on their cytological fingerprints and ultimately elucidate molecular targets important for disease treatment.. Publications:. Darienne R. Myers, Tannia Lau, Evan Markegard, Hyung W. Lim ,Herbert Kasler, Minghua Zhu, Andrea Barczak, John P. Huizar, Julie Zikherman ,David J. Erle , Weiguo Zhang , ...
Alam, Md. Ashraful and Uddin, Shaikh Jamal and Brown, Lindsay (2012) Mitogen-activated protein kinase and natural phenolic compounds in cardiovascular remodeling. In: Bioactive natural products. Studies in Natural Products Chemistry (38). Elsevier, Amsterdam, Netherlands, pp. 159-190. ISBN 978-0-444-59530-0 ...
The course will provide students with a knowledge of natural products obtained from animals and plants, including marine organisms, with the emphasis on the isolation, structure determination, biosynthetic origin, synthesis, mode of action and medicinal properties of substances.. ...
To equip students with a knowledge of natural products obtained from a range of sources including plants and marine organisms with the emphasis on the medicinal properties of substances; to describe extraction techniques and how these influence the chemical composition of the extract; to define compound classes of active constituents; to delineate the biosynthesis of selected compound classes; to show how selected compounds can be synthesised including a description of some industrial syntheses; to equip students with a basic understanding of how bioactive natural products are believed to work; to place natural products in the wider context of bioactive compounds.. ...
Buy the Paperback Book Discovery And Development Of Antidiabetic Agents From Natural Products by Goutam Brahmachari at Indigo.ca, Canadas largest bookstore. + Get Free Shipping on Health and Well Being books over $25!
Thus, alternatives to the statins are often sought by people experiencing negative side effects. It should be noted that a recent study published in the Annals of Internal Medicine do support the use of red yeast rice, actually a by-product of cooked rice on which red yeast is grown. The study found that red yeast rice in supplement form was effective in patients who had been unable to take statin drugs because the drugs caused muscle problems. The study also found that that red yeast rice did not cause liver impairment (Garloch, 2010 ...
Androgen receptor (AR) is a ligand-activated transcription factor and a validated drug target for all stages of prostate cancer. Antiandrogens compete with physiological ligands for AR ligand-binding domain (LBD). High-throughput screening of a marine natural product library for small molecules that inhibit AR transcriptional activity yielded the furanoditerpenoid spongia-13(16),-14-dien-19-oic acid, designated terpene 1 (T1). Characterization of T1 and the structurally related semi-synthetic analogues (T2 and T3) revealed that these diterpenoids have antiandrogen properties that include inhibition of both androgen-dependent proliferation and AR transcriptional activity by a mechanism that involved competing with androgen for AR LBD and blocking essential N/C interactions required for androgen-induced AR transcriptional activity. Structure activity relationship analyses revealed some chemical features of T1 that are associated with activity and yielded T3 as the most potent analogue. In vivo, T3 ...
Correction: The value of universally available raw NMR data for transparency, reproducibility, and integrity in natural product research Nat Prod Rep. 2019 01 01; 36(1):248-249. . View in PubMed. The value of universally available raw NMR data for transparency, reproducibility, and integrity in natural product research Nat Prod Rep. 2019 01 01; 36(1):35-107. . View in PubMed. Rare Pediatric Invasive Gliofibroma Has BRAFV600E Mutation and Transiently Responds to Targeted Therapy Before Progressive Clonal Evolution JCO Precis Oncol. 2019; 3. . View in PubMed. Noninvasive estimation of fetal lung maturity with magnetic resonance spectroscopy Am J Obstet Gynecol. 2018 08; 219(2):209-210. . View in PubMed. Association between Subcortical Morphology and Cerebral White Matter Energy Metabolism in Neonates with Congenital Heart Disease Sci Rep. 2018 09 19; 8(1):14057. . View in PubMed. Clinical Factors Associated with Cerebral Metabolism in Term Neonates with Congenital Heart DiseaseJ Pediatr. 2017 04; ...
Pesquisadores Participantes Roberto G. S. Berlinck David H. Sherman - Life Sciences Institute, University of Michigan One of the most underexplored classes of natural products from a metabolic pathway perspective includes complex alkaloids derived from terrestrial and marine sources. In addition to the fascinating genetic and biochemical mechanisms involved in construction of these secondary metabolites,…
Vast genetic resources ? blue gold on the international deep sea floo...Increasingly recognized as important to humankind for their potential ...Known as extremophiles the genetic make-up of organisms of the deep...The new report Bioprospecting of Genetic Resources in the Deep Seabed... Deep sea ecosystems hold the promise of huge potential contributions ...,Clear,rules,needed,to,govern,deep,sea,bioprospecting:,UNU,biological,biology news articles,biology news today,latest biology news,current biology news,biology newsletters
Acute lung injury (ALI) is a common, life-threatening complication among pediatric leukemia and lymphoma and hematopoietic stem cell transplant (HSCT) recipients. Although these children represent a relatively small and unique patient population, they account for the largest proportion of deaths of all pediatric diseases. The long-term goal of this project is to improve outcomes among these patients. Recently, the intratracheal administration of calfactant has resulted in decreased mortality among children with ALI including promising results among children with cancer and following HSCT. Consequently, the primary specific aim of this study is to assess the effect of calfactant on intensive care (PICU) survival among pediatric leukemia and lymphoma and HSCT patients with ALI. Secondary aims include assessment of the effect of calfactant on oxygenation and on the length of mechanical ventilation, PICU stay, and hospital stay. Calfactant therapy has been found to be of benefit in acute lung injury ...
With more than 10 years of accumulation, KBP has built a small molecule compound library with over 3,000,000 chemical compounds consisting of compounds designed and synthesized by KBP with unique chemical structures and high potency, compounds synthesized based on different core structures that cover almost all known core structures, and a natural product library of compounds extracted from plants, marine organisms and microorganisms.. Coupled with our bio-evaluation technology platform, the compound library enables KBP to identify and progress unique drugs that fit global unmet medical need quickly and efficiently.. Over 100 lead compounds have been screened from the library, and 3 compounds have entered into international clinical development.. ...
Product chemistry testing: evaluate the physicochemical properties and behaviour of chemical active substances in your plant protection products.
In this course students will learn the basic concepts of chemistry. Product chemistry is taught as well as advanced ingredient technology. Students
In this video Anthony Aglione from Pepsico Global R&D tells SelectScience about his work screening natural product libraries for sugar substitutes in the food and beverage industry. Anthony explains how, since its arrival, the new VIAFLO 384 from INTEGRA has become the workhorse of his laboratory. He also discusses some of the key benefits of the instrument including the GripTip technology, which improves confidence levels when transferring samples. Interview filmed by SelectScience at SLAS2013.
Srinivas, N; Jetter, P; Ueberbacher, B J; Werneburg, M; Zerbe, K; Steinmann, J; VanderMeijden, B; Bernardini, F; Lederer, A; Dias, R L A; Misson, P E; Henze, H; Zumbrunn, J; Gombert, F O; Obrecht, D; Hunziker, P; Schauer, S; Ziegler, U; Käch, A; Eberl, L; Riedel, K; DeMarco, S J; Robinson, J A (2010). Peptidomimetic antibiotics target outer membrane biogenesis in Pseudomonas aeruginosa. Science, 327(5968):1010-1013.. Geib, N; Weber, T; Wörtz, T; Zerbe, K; Wohlleben, W; Robinson, J A (2010). Genome mining in amycolatopsis balhimycina for ferredoxins capable of supporting cytochrome P450 enzymes involved in glycopeptide antibiotic biosynthesis. FEMS Microbiology Letters, 306(1):45-53.. Li, D B; Woithe, K; Geib, N; Abou-Hadeed, K; Zerbe, K; Robinson, J A (2009). Chapter 19. In vitro studies of phenol coupling enzymes involved in vancomycin biosynthesis. In: Hopwood, D A. Complex Enzymes in Microbial Natural Product Biosynthesis, Part A: Overview Articles and Peptides. Amsterdam: Elsevier, ...
Vesth, T. C., Nybo, J. L., Theobald, S., Frisvad, J. C., Larsen, T. O., Nielsen, K. F., Hoof, J. B., Brandl, J., Salamov, A., Riley, R., Gladden, J. M., Phatale, P., Nielsen, M. T., Lyhne, E. K., Kogle, M. E., Strasser, K., McDonnell, E., Barry, K., Clum, A., Chen, C. & 19 others, LaButti, K., Haridas, S., Nolan, M., Sandor, L., Kuo, A., Lipzen, A., Hainaut, M., Drula, E., Tsang, A., Magnuson, J. K., Henrissat, B., Wiebenga, A., Simmons, B. A., Mäkelä, M. R., de Vries, R. P., Grigoriev, I. V., Mortensen, U. H., Baker, S. E. & Andersen, M. R., 2018, In : Nature Genetics. 50, p. 1688-1695. Research output: Contribution to journal › Journal article › Research › peer-review ...
Product Name Active Ingredient Specification Test Method Red Yeast Rice Monacolin-K / Lovastatin 0.4%, 0.8% ,1.0%, 1.2% ,1.5% ,2.0%, 2.5%, 3%,5% HPLC Red Yeast Rice(Water-solubility) Monacolin-K / Lovastatin 1.0% ,1.5% ,2.0%, 2.5%, 3%
INBioPharm - Integrated Novel Natural Product Discovery and Production Platform for Accelerated Biopharmaceutical Innovation from Microbial Biodiversity project will develop a new, generic technology platform for the more efficient discovery of novel bioactive compounds with improved prospects to become medical products. A unique national collection of marine microorganisms at SINTEF/NTNU will be used as the basis for the development of different new, complementary molecular biology, analytical ...
Established in 2005 Natural Alternative Products are online retailers of health products containing only natural ingredients. We have a huge range covering Sports Nutrition & Supplements, Vitamins & Minerals, Healthly Foods & Drink, Organic Products, Personal Care Products, Weight Management Products and many more. Over those years weve built a strong base of loyal customers who care for their health and want to do that with natural health products. We keep our finger on the pulse and are always striving to offer the best and latest natural health products as they come on to the market. If you have a particular health product in mind and you cant find it on our site or even online, then email us and if it exists we will find it for you ...
Established in 2005 Natural Alternative Products are online retailers of health products containing only natural ingredients. We have a huge range covering Sports Nutrition & Supplements, Vitamins & Minerals, Healthly Foods & Drink, Organic Products, Personal Care Products, Weight Management Products and many more. Over those years weve built a strong base of loyal customers who care for their health and want to do that with natural health products. We keep our finger on the pulse and are always striving to offer the best and latest natural health products as they come on to the market. If you have a particular health product in mind and you cant find it on our site or even online, then email us and if it exists we will find it for you ...
Multicomponent synthesis of substituted N-aryl-4-aryl(3-pyridinyl-5-cyano)-6-(3,4-dihydroxybenzoylmethylsulphanyl)-2-methylnicotinamides, 6-allyl(carbamoylmethyl)sulphanyl-N-(4-chlorophenyl)-3-cyano-4-hetaryl-2-methyl-1,4-dihydronicotinamides and their antiradical and membrane-stabilizations properties
το κείμενο με τίτλο Elucidating and exploiting microbial bioactive product biosynthesis σχετίζετε με Βιοτεχνολογία
Biochemical disorders induced by cytotoxic marine natural products in breast cancer cells as revealed by proton NMR spectroscopy-based metabolomics. - Mathilde Bayet-Robert, Suzanne Lim, Chantal Barthomeuf, Daniel Morvan
The IHS and guidance document will tell you what type of permit you may need. (Products classed as negligible risk do not need a permit.). Minimal-risk products require a permit and will be cleared at the border. High-risk biological products also require a permit, and must go into a transitional or containment facility when they arrive in New Zealand.. Download the permit application to import biological products, microorganisms, and cell cultures:. ...
Our goal is to develop the yeast host and tools for natural product (NP) expression, using novel genomic and synthetic biology technologies. We will showcase these tools through heterologous expression of 600 natural product gene clusters from 10 filamentous fungi of diverse ecological origin. Our project will address all aspects of the genome to natural product process, including high-throughput and cost-effective gene cluster DNA synthesis, gene transcription and protein expression in yeast, through natural product biosynthesis.
Organic & Biomolecular Chemistry, our sister journal, publishes many articles that cover a variety of natural product chemistry.. We try to keep you updated here, although signing up to OBCs e-alert (free service) means you will receive the tables of content directly in your inbox every time an issue is published.. Hand-picked for you from the latest issues are:. Gold catalysis: synthesis of spiro, bridged, and fused ketal natural ...
View reliable Biological Products manufacturers on Made-in-China.com. This category presents Hyaluronic Acid, Pdo Thread, from China Biological Products suppliers to global buyers.
One of the largest sources of free continuing education courses for architects, engineers, contractors and other construction professionals.
Molecular Cloning, also known as Maniatis, has served as the foundation of technical expertise in labs worldwide for 30 years. No other manual has been so popular, or so influential.
The Shipping Weight includes the product, protective packaging material and the actual shipping box. In addition, the Shipping Weight may be adjusted for the Dimensional Weight (e.g. length, width & height) of a package. It is important to note that certain types of products (e.g. glass containers, liquids, fragile, refrigerated or ice packed) will often require protective packaging material. As such, these products will reflect a higher Shipping Weight compared to the unprotected product ...
The length of time for the expiration date or best used before date depends on the type of product, as well as the brand.. Perishable items (such as flax oils or certain probiotics) generally have shorter expiration dates. Although our warehouse is fully air-conditioned, these more fragile items are put in cold storage (freezer or refrigeration unit) for maximum freshness.. Our receiving department does its best to verify and then enter the correct expiration dates for all incoming products. However, discrepancies do occur from time to time. This being said, the exceptionally high turnover at iHerb ensures that our inventory is among the freshest in the industry.. ...
If you had muscle injury, a baby with a birth defect, or side effect of dietary supplements, contact our lawyers for lawsuit info at (866) 920-0753.
Cholesterol support products from bodykind including Red Sterol Complex from Higher Nature, Cholesterase from BioCare and more. Free UK delivery.
Firstly, I am not against doctors and/or medications and I am all for science, studies, data etc. I had a heart attack about 3yrs ago, was put on statins and BP medications which I stayed on for a year before deciding to try and get off them and rectify things by a more natural approach. I tried 3 different statins and they all came with awful side effects including lethargy and severe muscle aches. Today I have perfect BP and cholesterol, despite have a condition called aortic stenosis which I was born with. Ive had a couple of years ~ and great success from taking high doses of Omega 3s (I take an algal source of EPA/DHA), hawthorn, garlic and red yeast rice. Red yeast rice is probably the most interesting, better suited for lowering cholesterol rather than BP. It has the same actions in the body as regular statins so can actually be classed as a levostatin itself; it did temporarily get taken off the market I believe as it was too effective and comparable to regular statins so they tried to ...
China 100% Natural Red Yeast Rice Extract: 0.4%-3% Lovastatin; 0.4%, 1.5% Monacolin K., Find details about China Red Yeast Rice Extract, Monascus Purpureus from 100% Natural Red Yeast Rice Extract: 0.4%-3% Lovastatin; 0.4%, 1.5% Monacolin K. - Kingherbs Limited
Red Yeast Rice (RYR) has been used for almost 2,300 years. It originated in China and has been used as both a food coloring and a medicinal herb. In around 800 AD in China, it was taken internally to "invigorate the body, aid in digestion and revitalize the blood". RYR has also been used in Traditional Chinese Medicine (TCM) to help the spleen, eliminate phlegm, and improve blood circulation. In Japan, Red Yeast Rice is called hoji, which translates to "grain or bean overgrown with mold". RYR is made by fermenting rice with a species of yeast known as Monascus purpeus and contains compounds called monacolins. These chemicals inhibit the production of an enzyme doctors call "HMG-CoA reductase", which when blocked, stops the body from producing cholesterol. In the 1970s, Merck & Company scientists isolated the chemical monacolin K. Shortly after, they learned how to synthesize this chemical in the lab. They called it Lovastatin (Mevacor, Altoprev, Altocor), a drug that would forever change the way ...
Androgen receptor is a ligand-activated transcription factor and a validated drug target for all stages of prostate cancer. Antiandrogens compete with physiologic ligands for androgen receptor ligand-binding domain (LBD). High-throughput screening of a marine natural product library for small molecules that inhibit androgen receptor transcriptional activity yielded the furanoditerpenoid spongia-13(16),-14-dien-19-oic acid, designated terpene 1 (T1). Characterization of T1 and the structurally related semisynthetic analogues (T2 and T3) revealed that these diterpenoids have antiandrogen properties that include inhibition of both androgen-dependent proliferation and androgen receptor transcriptional activity by a mechanism that involved competing with androgen for androgen receptor LBD and blocking essential N/C interactions required for androgen-induced androgen receptor transcriptional activity. Structure-activity relationship analyses revealed some chemical features of T1 that are associated with
Introducing the new 2016 - 2017 editorial staff for the MSRJ! We are thrilled to welcome 20+ junior editors to our experienced MSRJ team. The journal has been making exciting new changes with the start of e-publication and we look forward to another productive year of publishing, editing, and supporting medical student research efforts around the world! 2016-2017 Executive Editorial Board Executive Editors James Polega, Executive Editor-in-Chief, is a fourth year medical student at Michigan State University College of Human Medicine. He completed a Bachelors of Science in Biology at Saginaw Valley State University in 2013. He has previous research experience in bariatric surgery, freshwater ecology, natural products chemistry, and antiquity metallic compositional determination. He has special interests in hematology and oncology. He plans to pursue a Med/Peds residency upon completion of medical school. Garrett Roe, Executive Editor, is a fourth year medical student at Michigan State University ...
Alsharaa, Abdulnaser (2010) Electrochemical Investigation and Analytical Determination of Nucleic Acid Constituents at Different Carbon Composite Electrode Surfaces. Masters thesis, King Fahd University of Petroleum and Minerals.. Haladu, Shamsuddeen Abdullahi (2010) Total Synthesis of Bioactive Natural Products. Masters thesis, King Fahd University of Petroleum and Minerals.. Abu-Thabit, Nidal Y. M. (2010) Synthesis of Ionic Polymers for Proton Exchange Membrane Fuel Cells and Viscosity Modifications. PhD thesis, King Fahd University of Petroleum and Minerals.. LAJAMI, ABDULLAH (2010) synthesis of polyisoxazolidines as potential corrosion inhibitors. Masters thesis, King Fahd University of Petroleum and Minerals.. Al Maythalony, B (2009) SYNTHESIS OF NEW GOLD(III) COMPLEXES WITH ALKYLDIAMINE AND CYANIDE LIGANDS AND THEIR INTERACTION WITH SOME BIOLOGICALLY IMPORTANT LIGANDS. PhD thesis, King Fahd University of Petroleum and Minerals.. Moosa, Basem (2010) asymmetric induction in 1,3-dipolar ...
Bone meal (or Bone manure) is a mixture of finely and coarsely ground animal bones and slaughter-house waste products. It is used as an organic fertilizer for plants and as a nutritional supplement for animals. As a slow-release fertilizer, bone meal is primarily used as a source of phosphorus and protein. Finely ground bone meal may provide a quicker release of nutrients than the coarser ground version of bone meal. Bone meal, along with a variety of other meals, especially meat meal, is used as a dietary/mineral supplement for livestock. It is used to feed monogastric animals with bone meal from ruminants, and vice versa, to prevent the spread of bovine spongiform encephalopathy (BSE) or "mad cow disease". Proper heat control can reduce salmonella contaminants. Bone meal once was often used as a human dietary calcium supplement. Research in the 1980s found that many bone meal preparations were contaminated with lead and other toxic metals, and is no longer recommended as a calcium source. As a ...
Iron nanoparticles are widely utilized in cosmetic makeup products, food products and textile industry. peroxidation and proteins carbonylation along with a significant lower in activity of 1448671-31-5 supplier Superoxide Dismutase, Catalase, total Glutathione amounts and total antioxidant capability with raising focus of shown nanoparticles indicated that the cells had been under oxidative tension. The study established WAG cell series as an operational system to study toxicity systems of nanoparticles on aquatic organisms. Launch Nanoparticles possess exclusive physicochemical properties credited to their little size, huge surface area region and high reactivity. These particular properties give them ideal for many applications such as therapeutics [1], environmental remediation [2], antimicrobial realtors [3], transfection vectors [4], customer items [5] and neon brands [6]. Therefore, nanotechnology based sectors are developing leading to large range creation of engineered nanoparticles ...
... is an international multidisciplinary peer-reviewed journal covering all fundamental and applied research areas of chemical sciences including organic chemistry, inorganic chemistry, synthetic chemistry, medicinal chemistry, analytical chemistry, organometallic chemistry, nuclear chemistry, electrochemistry, atmospheric chemistry, environmental chemistry, materials chemistry, materials science, supramolecular chemistry, physical chemistry, polymer chemistry, bioinorganic chemistry, physical organic chemistry, surface chemistry, biochemistry, molecular biology, chemical biology, food chemistry, natural product chemistry, neurochemistry, pharmacology, photochemistry, photobiology, toxicology, nanoscience, nanotechnology, agrochemistry, green chemistry, marine chemistry, geochemistry, petrochemistry, radiochemistry, astrochemistry, molecular physics, chemical engineering, quantum chemistry, and theoretical and computational chemistry. The journal publishes full research ...
If you have recurring infections some of the discharge may be cultured to see if yeast or another Over 70% of women develop at least one yeast infection yeast infection physical exam protocol treatment during their life and over 40% of women fostering fungal growth Repeated intercourse over a short period of time Stress pregnancy Research; Cancer Summary; Testimonials; Videos; References; Candida Yeast: Chemical Poisoning: NCRF is a Federally Registered 501(c)(3) It is usually not itchy and does not bother the baby. WebMD experts and contributors provide answers to: home remedies for thrush oropharyngeal candidiasis synonyms oropharyngeal candidiasis pronunciation oropharyngeal candidiasis; oropharyngeal catheter; Red yeast rice supplements can be found online or at your local natural health store. Mild Yeast Infection No Discharge Oral Alcohol Candida mostly eat Research shows that candida albicans In case you are thinking about natural yeast infection treatment while to get the infection are ...
Product of biological evolution[edit]. Human preferences toward things in nature, while refined through experience and culture ... are hypothetically the product of biological evolution. For example, adult mammals (especially humans) are generally attracted ... induce a strengthening in emotive and biological terms at a neural level; (iv) support, according to the many clinical ...
Metal Ions in Biological Systems. 39: 741-59. doi:10.1201/9780203909331.ch22. ISBN 978-0-8247-0765-1. PMID 11913143.. also ... Pro-duct 180W 0.12% 1.8×1018 y α 176Hf ... Biological role[edit]. Tungsten, at atomic number 74, is the ... Astrid Sigel; Helmut Sigel (2002). Molybdenum and tungsten: their roles in biological processes. CRC Press. p. 741 ff. ISBN 0- ... Lagarde, F.; Leroy, M. (2002). "Metabolism and toxicity of tungsten in humans and animals". Metal ions in biological systems. ...
van Dalen, CJ; Kettle, AJ (15 August 2001). "Substrates and products of eosinophil peroxidase". The Biochemical Journal. 358 ( ... Journal of Biological Inorganic Chemistry. 1 (5): 476-485. doi:10.1007/s007750050081. Furtmüller, PG; Zederbauer, M; Jantschko ... The Journal of Biological Chemistry. 283 (42): 28629-40. doi:10.1074/jbc.m801196200. PMC 2661412 . PMID 18694936. ...
Stoichiometry and measurement of reaction products". Biochimica et Biophysica Acta. 611 (2): 251-68. doi:10.1016/0005-2744(80) ... Biological & Pharmaceutical Bulletin. 31 (12): 2187-2193. doi:10.1248/bpb.31.2187. Rescigno A, Casañola-Martin GM, Sanjust E, ... and color and also decreases the availability of certain essential amino acids as well as the digestibility of the products. As ...
"Natural Product Reports. 19: 312-331. doi:10.1039/B100916H. PMID 12137280.. *^ Jin L, Abrahams JP, Skinner R, Petitou M, Pike ... Highest negative charge density of any known biological molecule Heparan sulfate. GlcUA or IdoUA or IdoUA(2S). GlcNAc or GlcNS ... Heparin: Chemical and Biological Properties, Clinical Applications. CRC Press, Inc. p. 1.. ... Other biological functions for which CSGAGs are known to play critical functions in include inhibition of axonal growth and ...
Control: Triclopyr herbicide; Milestone is 5-7 oz/A.; Biological herbicide. A natural, biological herbicide to control TSA is ... The product is called SolviNix™. TSA beetle. A beetle known as Gratiana boliviana (TSA beetle) has been investigated over the ... The tropical soda apple leaf beetle (Gratiana boliviana) has been used successfully as an agent of biological pest control to ... Probably through contaminated seed or other agricultural products Impact: Crowds out native species and forage for livestock ...
No biological tests confirm major depression. Biomarkers of depression have been sought to provide an objective method of ... Gordon Duff (31 May 2006). "Updated prescribing advice for venlafaxine (Efexor/Efexor XL)". Medicines and Healthcare products ... The broad clinical aim is to formulate the relevant biological, psychological, and social factors that may be impacting on the ... Adolf Meyer put forward a mixed social and biological framework emphasizing reactions in the context of an individual's life, ...
ISBN 1-4757-1856-X. John W. Blunt, Murray H. G. Munro (2013). Dictionary of Marine Natural Products. CRC Press. ISBN 0-8493- ... Biological Control. 44: 24. doi:10.1016/j.biocontrol.2007.10.005. Stewart, M; Capon, R. J.; Lacey, E; Tennant, S; Gill, J. H. ( ... Journal of Natural Products. 68 (4): 581-4. doi:10.1021/np049614y. PMID 15844954. Capon, R. J.; Stewart, M; Ratnayake, R; Lacey ... Journal of Natural Products. 68 (4): 581-4. doi:10.1021/np049614y. PMID 15844954. Stolk, Amelia C. (1969). "Four new species of ...
"Natural Product Reports. 25 (6): 1118-30. doi:10.1039/b717196j. PMC 2654777 . PMID 19030605.. ... Biological process. • mitochondrion organization. • intrinsic apoptotic signaling pathway. • activation of cysteine-type ... An enzymic function for erythrocuprein (hemocuprein)". The Journal of Biological Chemistry. 244 (22): 6049-55. PMID 5389100.. ... Cytochrome c has been used to detect peroxide production in biological systems. As superoxide is produced, the number of ...
Journal of Natural Products. 71 (9): 1657-1659. doi:10.1021/np8004024. PMID 18774863. ... American Journal of Agricultural and Biological Sciences. 5 (2): 210-214. doi:10.3844/ajabssp.2010.210.214. Sappapan, Ruengrit ...
Biological N Function in Forage livestock systems. American Society of Agronomy. 1976. p. 42. ISBN 089118046X. .. ... "Pulses and Derived Products". Definition and Classification of Commodites. Food and Agriculture Organization. 1994.. ...
"Biological Psychiatry. 84 (2): 138-147. doi:10.1016/j.biopsych.2017.09.009. PMC 5862738. PMID 29129318.. ... "Medicines and Healthcare products Regulatory Agency (MHRA). Archived from the original on 13 November 2008.. ... No biological tests confirm major depression.[106] Biomarkers of depression have been sought to provide an objective method of ... The biopsychosocial model proposes that biological, psychological, and social factors all play a role in causing depression.[3] ...
The products are marketed as biological and biochemical fertilizer catalysts that increase nutrient availability and enhance ... "Nutritional: Biological Catalyst". Loveland Products. Archived from the original on 6 November 2014. Retrieved 14 September ... In July 2012, Agricen entered a strategic partnership with Loveland Products, Inc., a provider of crop input products and part ... In August 2014, Agrium, through Loveland Products, acquired a controlling interest in Agricen. Agricen's products, which are ...
"Riverbank Erosion Control Products". Nasermoaddeli, M; Pasche. "Modelling of Undercutting and Failure of Non-cohesive ... Joint Biological Assessment. "River Maintenance Methods Attachment" (PDF). Retrieved 2013-11-24. Hansen, k (2000). Construction ... Typically, willows and cottonwood poles are the most useful materials, however, fiber products may also be used are then ...
Halvorsen BL, Blomhoff R (2011). "Determination of lipid oxidation products in vegetable oils and marine omega-3 supplements". ... Chemico-Biological Interactions. 188 (1): 171-180. doi:10.1016/j.cbi.2010.06.015. PMID 20619253. ...
List of products subject to obligatory certification is defined by Gosstandart and can be seen on www.gost.ru. The very system ... Immune biological preparations. The obligatory GOST R certification system consists of sub-systems of certificating homogeneous ... This system is aimed at providing the Customer with safety and high quality of products and services. This right of the ... The obligatory requirements are the ones that deal with safety, conformity of products, ecological friendliness and inter- ...
Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to ... A biopharmaceutical, also known as a biologic(al) medical product, biological,[1] or biologic, is any pharmaceutical drug ... a biological medicinal product[28] is one of the active substance(s) produced from or extracted from a biological (living) ... As indicated the term "biologics" can be used to refer to a wide range of biological products in medicine. However, in most ...
Some laboratory research has investigated the biological activity of erythravine, but the relevance to effects in humans is ... Journal of Natural Products. 70 (1): 48-53. doi:10.1021/np060254j. PMID 17253849. Flausino Jr, OA; Pereira, AM; Da Silva ... Biological & Pharmaceutical Bulletin. 30 (2): 375-8. doi:10.1248/bpb.30.375. PMID 17268084. Faggion, Silmara Aparecida; Cunha, ...
Journal of Biological Chemistry. 264 (20): 11744-11749. Dewick, Paul M (2009). Medicinal Natural Products: a biosynthetic ...
ISBN 978-1-59158-169-7. Lenneberg, Eric (1967). Biological Foundations of Language. New York: Wiley. ISBN 0-89874-700-7. ... Lightbown, Patsy (1990). "Chapter 6: Process-product research on second language learning in classrooms". In Harley, Birgit. ...
Journal of Biological Chemistry. 287(10). 7683-7691 Ishiguro and Nakamura (1994) Characterization of a cDNA encoding a novel ... Additionally, WRKYs are needed for proper expression of lignin biosynthetic pathway genes, which form products necessary for ... Journal of Biological Chemistry. 284(27). 17975-17988 Kamal, Singh, Upadhyay, Sharma, Gupta, et al. (2014) Identification of ... Proceedings of the 8th International Conference on Mushroom Biology and Mushroom Products. Wu, Guo, Wang and Li (2005) The WRKY ...
"Biological Species in Pleurotus". The University of Tennessee-Knoxville. Retrieved 2011-03-11. Segedin, BP; Buchanan, PK; ... World Society for Mushroom Biology and Mushroom Products. pp. 91-101. Peterson, Ronald H.; Hughes, Karen W. & Psurtseva, ... Mushroom biology and mushroom products: proceedings of the 2nd International Conference, June 9-12, 1996 (PDF). University Park ...
Yu, D.; Xu, F.; Zeng, J.; Zhan, J. (2012). "Type III polyketide synthases in natural product biosynthesis". IUBMB Life. 64 (4 ... Journal of Biological Chemistry. 286 (8): 6659-68. doi:10.1074/jbc.M110.196279. PMC 3057783 . PMID 21148316. Jez, J. M.; Ferrer ... Austin, M. B.; Noel, J. P. (2003). "The chalcone synthase superfamily of type III polyketide synthases". Natural Product ... Journal of Biological Chemistry. 282 (52): 37702-37709. doi:10.1074/jbc.M707569200. PMID 17932040. Katsuyama, Y.; Miyazono, K ...
Agricultural and Biological Sciences. Retrieved 20 November 2017. Bugg, Timothy D.H.; Ahmad, Mark; Hardiman, Elizabeth M.; ... Lignin-modifying enzymes benefit industry as they can break down lignin; a common waste product of the paper and pulp industry ... Due to Lignin, the plant waste is relatively inert towards degradation and causes the large accumulation of waste products. ... Singh, Rahul (June 2011). "The emerging role for bacteria in lignin degradation and bio-product formation". Current Opinion in ...
"Processing of alkylcobalamins in mammalian cells: A role for the MMACHC (cblC) gene product". Molecular Genetics and Metabolism ... Journal of Biological Chemistry. 284: 33418-33424. doi:10.1074/jbc.M109.057877. " ...
Biological oceanography (2nd ed.). Chichester: Wiley-Blackwell. ISBN 978-1-4443-3302-2. Bailey, Sean W.; Werdell, P. Jeremy (1 ... "Product Level Descriptions". Ocean ColorWeb. Archived from the original on 3 February 2014. Retrieved 29 October 2013. Ryther, ... SeaWIFS (Sea-Viewing Wide Field-of-View Sensor) was a satellite-borne sensor designed to collect global ocean biological data. ... Level 4 data may be used for similar research if interested in a modeled product. NASA offers free software designed ...
In food web terminology, complexity is a product of the number of species and connectance.[70][71][72] Connectance is "the ... Linkages connect to nodes in a food web, which are aggregates of biological taxa called trophic species. Trophic species are ... biological, physical, and social interactions that affect, sustain, or are modified by living organisms, including humans".[77] ... as well as products secreted, excreted or exuded from organisms (e.g. extra-cellular polymers, nectar, root exudates and ...
"A Professional and Personal Odyssey". Journal of Biological Chemistry. 284: 19765-19780. doi:10.1074/jbc.X109.007518. Haupt, ... "Biosynthesis of Lichen Substances, Products of a Symbiotic Association". Angewandte Chemie International Edition in English. 8 ...
Keywords , biosimilar products - originator products*Keywords , biotherapeutic products (biotherapeutics)*Keywords , clinical ... Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO Expert Committee on Biological Standardization, ... "biosimilar products", "follow-on protein products" and "subsequent-entry biologics" have been coined by different jurisdictions ... to a licensed originator product. These products rely, in part, for their licensing on prior information regarding safety and ...
New Methodologies for Natural Products Chemistry (R01) RFA-RM-09-005. Roadmap ... Chief, Biological Chemistry and Macromolecular Biophysics (BCMB) IRG Center for Scientific Review National Institutes of Health ... These include natural products (6%), natural product derivatives (27%), synthetic compounds with natural-product-derived ... compounds are natural products or have been derived from, or inspired by, a natural product." The utility of nature as a source ...
... Page Content. Overview. Human cells, tissues, and cellular and tissue-based products (HCT/Ps) that do not ... Some examples of HCT/Ps regulated as biological products are listed below: *. Allogeneic peritoneal membrane product in guided ... Home , Advocacy , Regulatory Affairs , Cellular Therapies , Biological Products Home , Advocacy , Regulatory Affairs , Cellular ... 351 products. For these HCT/Ps regulated as biological products, the FDA requires premarket review of safety and efficacy data ...
... immunoglobulin products, products containing cells or microorganisms, and most protein products. Biological products subject to ... What is a biological product? Biological products, like other drugs, are used for the treatment, prevention or cure of disease ... Are the biologic development requirements different than the requirements for a new drug product? Biological products are a ... A sponsor may be able to demonstrate product comparability between a biological product made after a manufacturing change and a ...
A) A copy of all adverse biological product experience reports submitted to the licensed manufacturer of the final product;. (B ... Any adverse event associated with the use of a biological product in humans, whether or not considered product related, ... Unexpected adverse experience: Any adverse experience that is not listed in the current labeling for the biological product. ... Expedited Safety Reporting Requirements for Human Drug and Biological Products. AGENCY: Food and Drug Administration, HHS.. ...
The development and manufacture of biopharma products is set to be one of the fastest growing sections of the industry. ... The rapidly changing international regulatory demands and expectations for these products. *How these requirements can be ... "Excellent overview of production of biotech products!"Sandra Grote / Beverborg, Organon, The Netherlands ... reduce product losses and improve yields? This course shows how - using case studies, team-based exercises and discussion of ...
Biological effects on eyes and skin are described. Industrial data on ocular IR radiation hazards among workers is presented. ... The biological effects of exposure to broadband, non coherent infrared (IR) sources are reviewed. Historical aspects and ... website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products ...
This book presents an updated discussion of the chemical composition and biological properties of the main bee products. ... Bee Products - Chemical and Biological Properties. Editors. * José M. Alvarez-Suarez Copyright. 2017. Publisher. Springer ... Bee Products - Chemical and Biological Properties. Editors: Alvarez-Suarez, José M. (Ed.) ... Presents an updated discussion on the chemical composition and biological properties of the main bee products, which until now ...
Free Shipping and expert advice on a wide range of do it yourself pest control products, pest control supplies, pest control ...
Proposed Categorization of Products-Proposed Order. Category I. Licensed biological products determined to be safe and ... The comment stated that because all biological products are prescription products administered by health care providers, the ... product standards, or other conditions necessary or appropriate for a biological products safety and effectiveness. ... PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS. End Part 3. The authority citation for 21 CFR part 610 continues to read as ...
Biological, Radiological, and Nuclear (CBRN) Respiratory Protection Handbook, DHHS (NIOSH) Publication 2018-166 ... Chemical, Biological, Radiological, and Nuclear (CBRN) Respiratory Protection Handbook pdf icon[PDF - 8,103 KB] ... Chemical, Biological, Radiological, and Nuclear (CBRN) Respiratory Protection Handbook. ... biological, radiological, and nuclear (CBRN) hazards and toxic industrial chemicals. Prior to 2001, there were no standards for ...
The present invention is to present a biological sample analyzer, comprising: a characteristic information obtainer for ... The present invention relates to a biological sample analyzer and computer program product for analyzing biological samples ... A computer program product for enabling a computer to control a biological sample analyzer, comprising: a computer readable ... A computer program product for enabling a computer to control a biological sample analyzer, comprising: a computer readable ...
... to revise and clarify procedures for application holders of an approved drug or biological product to change the product ... Licenses for biological products are to be issued only upon a showing that the biological product is safe, pure, and potent (42 ... include drugs approved under the FD&C Act and biological products licensed under the PHS Act, other than biological products ... FDAs regulations in 21 CFR part 201 apply to all prescription drug products, including biological products. ...
... biochemical products market in China and the trend in recent years ... This report presents a clear picture about the overall development of biological & ... CHAPTER 1 PRODUCT DEFINITION. CHAPTER 2 MARKET SIZE. 2.1 Analysis On The Biological & Biochemical Products Market Size. 2.2 An ... Product definition. Biological & biochemical products mentioned in this report is a general concept, it shall include the ...
Find septic tank biological product articles on Environmental XPRT, the worlds largest environmental industry marketplace and ... septic tank biological product Articles. Related terms for "septic tank biological product ": septic tank articles ... All Products Services Software Training Applications Companies News Articles Books Magazines Events Downloads Videos ... This by-product is named as sludge. Typically in solid, semi-solid or liquid state, it is in fact an amalgamation of all the ...
Results for advanced biological wastewater treatment product equipment from Aero-Fac, BioMaxx, Dow FILMTEC and other leading ... advanced biological wastewater treatment product equipment Related terms for "advanced biological wastewater treatment product ... biological wastewater treatment equipment , biological wastewater treatment product equipment , advanced biological wastewater ... Bio Augmentation Products. Advanced/BIO is a new range of biological wastewater treatment products that contain both Bacteria ...
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C) a biological product, the agency center charged with premarket review of biological products shall have primary jurisdiction ... iii) a biological product, the agency center charged with premarket review of biological products shall have primary ... M) the distribution of a collection of finished medical devices, which may include a product or biological product, assembled ... or biological product.. (B) The Secretary shall conduct the premarket review of any combination product under a single ...
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Start Early and Finish Strong with DiPel Biological Insecticide. Begin your growing season right with an early application of ... Leap ES Bacterial Disease Management / Biological Insecticide Emulsifiable Suspension Info Label/SDS ... Valent BioSciences LLC , Sumitomo Chemical Co., Ltd. , Valent Canada - Crop and Professional Products ...
Biological Insecticide, 32 Oz Concentrate, Omri from Sears at Westfield Galleria at Roseville. Browse the latest styles online ... Lawn & Garden Products,mlgnlg6336 Monterey b.t. Biological Insecticide, 32 Oz Concentrate, Omri ... This organic product is OMRI listed, and is safe for people and pets when used as directed. Can be used on edible plants up to ... Monterey B.t. is a biological insecticide containing Bacillus thuringiensis, a naturally occurring bacterium, used for ...
Several categories of drugs are identical to or derived from biological products. Some hormones given as drugs, for example, ... Nomenclature for Biological Products Nomenclature for Biological Products. Chapter:. (p. 529) Nomenclature. Author(s):. ... Several categories of drugs are identical to or derived from biological products. Some hormones given as drugs, for example, ...
"Reference product" is defined as the single biological product licensed under Section 351, Subsection (a) of the PHS Act ... The biological product and reference product utilize the same mechanism or mechanisms of action for the condition or conditions ... Biological Products Previously Approved as New Drugs. In general, a marketing application for a biosimilar product must be ... The biological product is highly similar to the reference product, notwithstanding minor differences in clinically inactive ...
such biological product is in a product class for which a biological product in such product class is the subject of an ... i) "Biological product" definedIn this section: (1) The term "biological product" means a virus, therapeutic serum, toxin, ... B) each package of the biological product is plainly marked with- (i) the proper name of the biological product contained in ... h) Exportation of partially processed biological productsA partially processed biological product which- (1) is not in a form ...
  • FDA regulations and policies have established that biological products include blood-derived products, vaccines, in vivo diagnostic allergenic products, immunoglobulin products, products containing cells or microorganisms, and most protein products. (fda.gov)
  • Most proteins intended for therapeutic use, including cytokines (e.g., interferons), enzymes (e.g. thrombolytics), and other novel proteins, except for those that are specifically assigned to the Center for Biologics Evaluation and Research (CBER) (e.g., vaccines and blood products). (fda.gov)
  • The report also goes into detail on the most commonly reported issues for non-blood products licensed by CBER, which include allergenic products, blood derivatives, IVDs, vaccines and licensed HCT/Ps. (raps.org)
  • For vaccines, which accounted for the highest number of reports in this category, FDA says it saw an increase in reports of products not meeting specification, most of which had to do with the product's appearance. (raps.org)
  • Mixing, diluting, or repackaging of blood and blood components for transfusion, vaccines, cell therapy products, or gene therapy products The guidance does not alter FDA's existing approach to regulating the collection and processing of blood and blood components. (gmp-compliance.org)
  • In addition, FDA intends to consider regulatory action if licensed vaccines, cell therapy products, and gene therapy products are subject to additional manufacturing, including mixing, diluting, or repackaging, in ways not specified in the product's approved BLA as described in the approved labelling for the product. (gmp-compliance.org)
  • Active pharmaceutical ingredients (API), vaccines serum, and hematological products (whole blood and plasma derivatives), recombinant DNA products, cell cultures (micro-organisms or eukaryotic cells), gene therapy and cell therapy products, antigens, allergens, antivenoms, etc. are some examples of biological products. (sbwire.com)
  • This book presents an updated discussion of the chemical composition and biological properties of the main bee products. (springer.com)
  • He has extensively studied the quality parameters of honey, especially that from monofloral origin, as well as the relationship between its chemical composition and biological properties. (springer.com)
  • Since 2001, the U.S. Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH) has established performance and design standards for respiratory protective devices (RPDs) to protect against chemical, biological, radiological, and nuclear (CBRN) hazards and toxic industrial chemicals. (cdc.gov)
  • GAC is used to adsorb small quantities of soluble organics and inorganic compounds such as nitrogen, sulfides and heavy metals remaining in the wastewater following biological or physical-chemical treatment. (environmental-expert.com)
  • Reaction rule-based models in combination with the chemical kinetics information will enable the prediction of transformation product evolution during ozonation. (rsc.org)
  • The Fulbright Program in Ukraine is pleased to invite you to a seminar "Total Synthesis of Natural Products as a Driving Force for Chemical and Biological Discovery" by Fulbright Ph.D. student 2011-2016 Nataliia Shymanska , to be held on Tuesday, December 1, 2015, 6:00 p.m. , at the Fulbright Office (20 Esplanadna Street, Suite 904, M "Palats Sportu", Kyiv). (org.ua)
  • We are professional manufacture and develope of high quality and standard hot products, standard extract, plant extract by rate, herb database, chemical product, health products etc. (locateindia.com)
  • Methods: Stability samples were withdrawn at periodic intervals, and evaluated for physical stability (color, clarity, viscosity and pH), chemical stability (total phenolic (TPC), scopoletin, asiatic acid and bacoside A content), and biological activities (free radical scavenging, anti-acetylcholinesterase, and antianxiety). (eurekaselect.com)
  • Results: The chemical indicators and biological activities were significantly decreased in both accelerated and long term stability samples compared to corresponding control samples. (eurekaselect.com)
  • We develop, manufacture, and deliver a portfolio of medical countermeasures for biological and chemical threats as well as emerging infectious diseases. (ebsi.com)
  • Chemical agents are non-living toxic products, such as vapors, gases, aerosols, liquids, and solids that can cause serious harm or death to those exposed. (ebsi.com)
  • 4) with respect to plants or biological control organisms, be grown or handled under post-entry quarantine conditions by or under the supervision of the Secretary for the purposes of determining whether the plant or biological control organism may be infested with plant pests or may be a plant pest or noxious weed. (house.gov)
  • A2085 was therefore selected as an active ingredient for biocontrol products and deposited under provisions of the Budapest Treaty in the Belgian Co-Ordinated Collections of Micro-Organisms (BCCM/MUCL) collection (accession MUCL54911). (mdpi.com)
  • Coping with Biological Grown on Stone Heritage Objects also emphasize issues on bioreceptivity of stones and the factors influencing biological growth and includes an outline of the various organisms able to develop on stones, a discussion on the bioprotection of stones by biofilms and lichens, a review of the main analytical techniques, and a section on bioremediation. (nhbs.com)
  • Biological agents are naturally occurring toxins or organisms that can result in illness or death to humans, animals, and crops. (ebsi.com)
  • Biological pigments, also known simply as pigments or biochromes, are substances produced by living organisms that have a color resulting from selective color absorption. (wikipedia.org)
  • In addition to the hypoxia (HIF1a) pathway products, SwitchGear offers the following reporter assay profiling sets in both plate format and biomarker subsets: CREB, NF-kB, heat shock (HSF), p53, STAT, serum response factor (SRF), and cholesterol biosynthesis (SREBP). (mtbeurope.info)
  • We identified a new virus associated with equine serum hepatitis and confirmed its pathogenicity and transmissibility through contaminated biological products. (cdc.gov)
  • Theiler's disease has been described in horses in many areas of the world after treatment with a variety of equine serum products, including tetanus antitoxin ( 3 - 8 ), botulinum antitoxin ( 9 ), antiserum against Streptococcus equi ( 4 , 10 ), pregnant mare's serum ( 4 ), and equine plasma ( 1 , 2 , 5 , 11 ). (cdc.gov)
  • Lampire sells human and animal blood antibodies and related products, including serum and plasma, that are used in diagnostic testing by some of the world's leading pharmaceutical and life science companies, Krug said. (lampire.com)
  • Innovator manufacturers of reference biological products are granted 12 years of exclusive use before biosimilars can be approved for marketing in the United States. (morganlewis.com)
  • In order to reduce prescribing errors, but still convey the message that biosimilars (and related biological products) are indeed similar to the reference product, the naming convention set forth in the Draft Guidance consists of a "proper name" for each licensed product that will be made up of a "core name" and a suffix. (lexology.com)
  • A brief overview of the phases of the regulatory development pathway for HCT/Ps regulated as biological products is shown below. (aabb.org)
  • In addition to the regulatory requirements for HCT/Ps, biological products are subject to Current Good Manufacturing Practice (CGMP) during the investigational and marketing phases of product development. (aabb.org)
  • These frequently asked questions have been developed for the CDER Small Business and Industry Assistance Web site to help small pharmaceutical businesses understand the regulatory process for therapeutic biological products. (fda.gov)
  • What Center has the regulatory responsibility for therapeutic biological products? (fda.gov)
  • Regulatory action and discontinuation of supply can cause catastrophic revenue losses in this high risk sector, so how can you assure supply, reduce GMP risks, reduce product losses and improve yields? (nsf.org)
  • The UK's Medicines and Healthcare products Regulatory Agency (MHRA) found Apotex Research Private Limited's Bangalore, India-based manufacturing site to be noncompliant. (raps.org)
  • SwitchGear Genomics, Inc., a provider of products for studying regulatory elements in the human genome, has launched cost-effective, high-throughput research tools for screening transcriptional activation and repression in a number of key biological pathways. (mtbeurope.info)
  • However, competitive costs of therapeutic products, requirement of highly skilled labor for high value low volume biological product manufacturing, limited availability foreign capital, and stringent regulatory affairs regarding the manufacture of biological products are restraining the global biological product manufacturing market. (sbwire.com)
  • FDA is still "considering the most effective regulatory approach to implement [the] naming convention for previously licensed products, including rulemaking, and will issue additional information. (lexology.com)
  • However, stringent regulatory framework and the requirement of skilled personnel for the effective use of biosurgery products may challenge market growth to a certain extent in the coming years. (marketresearch.com)
  • The agency also says it saw an increase in the number of reporting establishments from 1,907 in FY2015 to 1,950 in FY2016, including three more allergenic product manufacturers, five more blood derivative manufacturers and five more in vitro diagnostic (IVD) manufacturers. (raps.org)
  • Based on end-user, the biological product manufacturing market has been segmented into hospitals, research and academic institutes, clinics and specialty trials, diagnostic labs, and others. (sbwire.com)
  • Rising incidence of chronic diseases across the world, availability of better diagnostic facilities, advances in the drug discovery and pharmaceutical R&D sector, and rising government initiatives are some of the factors attributed to the high growth of the biological product manufacturing market. (sbwire.com)
  • The product indicated as " Research reagents " in the column Intended Use cannot be used for diagnostic nor any medical purpose. (ibl-japan.co.jp)
  • These systems typically consist of a multi-stage treatment process that includes filtration, biological treatment, and disinfection of wastewater prior to discharge. (environmental-expert.com)
  • Filtration systems for containers and mobile shelters include a complete product line with many optional accessories and have been delivered to a variety of military customers (NATO forces and others) around the world. (beind.com)
  • The procedure used solvent extraction of autolyzed defatted seed meals, followed by hydrolysis product purification using gel filtration chromatography and reversed-phase HPLC. (illinois.edu)
  • Biological products, like other drugs, are used for the treatment, prevention or cure of disease in humans. (fda.gov)
  • In contrast to chemically synthesized small molecular weight drugs, which have a well-defined structure and can be thoroughly characterized, biological products are generally derived from living material--human, animal, or microorganism-- are complex in structure, and thus are usually not fully characterized. (fda.gov)
  • Biological products subject to the PHS Act also meet the definition of drugs under the Federal Food, Drug and Cosmetic Act (FDC Act) . (fda.gov)
  • Note that hormones such as insulin, glucagon, and human growth hormone are regulated as drugs under the FDC Act , not biological products under the PHS Act . (fda.gov)
  • Following initial laboratory and animal testing that show that investigational use in humans is reasonably safe, biological products (like other drugs), can be studied in clinical trials in humans under an investigational new drug application (IND) in accordance with the regulations at 21 CFR 312. (fda.gov)
  • Several categories of drugs are identical to or derived from biological products. (amamanualofstyle.com)
  • On 3 April 2012, the Brazilian government decided in Decree no. 7.713 to apply a margin of preference of 8% to 25% for the public procurement of nationally produced pharmaceutical drugs and biological medical products. (globaltradealert.org)
  • Roberto Gambari, "Predictive Analyses of Biological Effects of Natural Products: From Plant Extracts to Biomolecular Laboratory and Computer Modeling," Evidence-Based Complementary and Alternative Medicine , vol. 2011, Article ID 383290, 4 pages, 2011. (hindawi.com)
  • Win big with SelectScience by sharing your opinion on laboratory products! (selectscience.net)
  • Our products are for laboratory research use only: Not for administration to humans! (biomol.com)
  • The Healthcare Reform Law does not require FDA to issue a guidance document to articulate the policies for each product class, and the nonissuance of guidance does not preclude approval of a biosimilar. (morganlewis.com)
  • Importantly, FDA may indicate in a guidance document that the "science and experience" for a product or product class does not allow approval through the biosimilar framework. (morganlewis.com)
  • There is a guidance document for biological products, including samples, to help you meet the IHS requirements. (mpi.govt.nz)
  • BioTek Field Applications Scientists (FAS) and Product Specialists provide unparalleled scientific support, assisting with experimental planning and assay optimization on BioTek's instrumentation and software. (biotek.com)
  • Research indicates this product presents better Igg1 isotype blocking, reducing false positive assay results. (lampire.com)
  • In addition, the report figures out the structure and concentration ratio of the current biological & biochemical products market in China by means of Bain's Market Structure Classification and Index of CR4. (marketpublishers.com)
  • This classification as a biological product is very significant, since it provides us with additional valuable exclusivity and confirms the FDA's acceptance of AGI-134's main mechanism of action as a vaccine," said Philip Serlin, Chief Executive Officer of BioLineRx. (pharmiweb.com)
  • In this article, recent advances in predicting organic micropollutant abatement during ozonation of municipal wastewater effluents are reviewed with a focus on (i) principle-based approaches for describing and modeling the reaction kinetics of ozone and ˙OH, (ii) transformation products and pathways, (iii) changes of biological activities, and (iv) biodegradation of transformation products in biological post-treatment. (rsc.org)
  • The new SwitchGear pathway sets utilize experimentally-validated luciferase reporter vectors to accurately quantify human promoter activity from complete sets of genes associated with inflammation, cholesterol biosynthesis, oncology, vascular biology, nuclear hormone receptor signalling, and many other important biological pathways. (mtbeurope.info)
  • There are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. (morganlewis.com)
  • In addition, the specification of no clinically meaningful differences relative to the reference biologic means that FDA will need to develop policies for each product class, because of the differences in potential safety issues for different biologics. (morganlewis.com)
  • In so doing, the Draft Guidance explains that consumers and health care professionals may inaccurately assume that a biological without a suffix (e.g., "filgrastim") differs in clinically meaningful way from a biosimilar (e.g., "filgrastim-sndz). (lexology.com)
  • Shandong Microwave Machinery Co.,Ltd. offers a full range of Microwave thawing machine for microwave thawing applicationsDryer Vacuum Microwave products biological temperature Microwave Microwave Low thawing. (epier.com)
  • Shandong Microwave Machinery Co.,Ltd. can supply products Microwave thawing machinefor operation at 915 MHz in a variety of Dryer Vacuum Microwave products biological temperature Microwave Microwave Low thawing configurations. (epier.com)
  • Shandong Microwave Machinery Co.,Ltd. can also provide Dryer Vacuum Microwave products biological temperature Microwave Microwave Low thawing for applications where the magnetron needs to be separate from the power supply and controls. (epier.com)
  • Shandong Microwave Machinery Co.,Ltd.is a Microwave thawing machine factory specializing in the production of Dryer Vacuum Microwave products biological temperature Microwave Microwave Low thawing, scientific research,manufacturing,installation, commissioning.Shandong Microwave Machinery Co.,Ltd.can provide Microwave thawing machinecustomers with design and services of 1-2000 tons Dryer Vacuum Microwave products biological temperature Microwave Microwave Low thawing. (epier.com)
  • Once adequate nonclinical safety data has been collected, the sponsor may submit an Investigational New Drug (IND) application to study the effects of the biological product in humans. (aabb.org)
  • If the data generated by the studies demonstrate that the product is safe and effective for its intended use, the data are submitted as part of a marketing application. (fda.gov)
  • The Healthcare Reform Law provides only for one reference product per application. (morganlewis.com)
  • The Secretary shall conduct a study of the role for and application of systems approaches designed to guard against the introduction of plant pathogens into the United States associated with proposals to import plants or plant products into the United States. (house.gov)
  • If you're applying to include a product catalogue or product list, you'll need to mention this in your permit application. (mpi.govt.nz)
  • A copy of the product catalogue, or product list, and a declaration of potential risk goods should be sent with the application. (mpi.govt.nz)
  • The global biological product manufacturing market has been segmented based on product type, end-user, application, and region. (sbwire.com)
  • BioTek's application notes present the latest-breaking scientific content covering the vast range of applications across our entire product line. (biotek.com)
  • Browse applications by topic, detection and product or use the simple keyword search to find the application notes that will facilitate your research. (biotek.com)
  • Our webinar archives are available for on-demand viewing - search to find a topic, application or product of interest. (biotek.com)
  • The report analyzes the biosurgery market and aims at estimating the market size and future growth potential of this market based on various segments such as product, application, and region. (marketresearch.com)
  • The report analyzes this market by product, application, and region. (marketresearch.com)
  • The Healthcare Reform Law gives FDA discretion in deciding whether to approve a product, except for any recombinant protein, through the biosimilar framework if "science and experience" do not allow such approval. (morganlewis.com)
  • The biotechnological/biological products segment includes micro-organism or eukaryotic cell culture, recombinant DNA technology products, gene therapy product, and cell therapy product. (sbwire.com)
  • Nevertheless, because of certain biological properties of UCB compared with bone marrow, UCB cells will grow or "engraft" in most patients and result in reconstitution of the haematopoietic and immune cells. (mja.com.au)
  • Concomitant with the issuance of the Draft Guidance, FDA issued Proposed Rules designating official names and proper names for certain biological products. (lexology.com)
  • Bee products are rich in several essential nutrients and non essential nutrients, as sugars, minerals, proteins, free amino acids, vitamins, enzymes and polyphenols, that seem to be closely related to their biological functions. (springer.com)
  • Biological targets are most commonly proteins such as enzymes, ion channels, and receptors. (wikipedia.org)
  • This ELISA kit can be used for measuring intact proinsulin, not including cleaved intermediate products, in mouse and rat samples. (ibl-japan.co.jp)
  • If all these advantages were true, magnetic freezing would represent a significant advance in freezing technology, not only for food preservation, but also for cryopreservation of biological specimens such as cells, tissues, and organs. (csic.es)
  • Issuance of a biologics license is a determination that the product, the manufacturing process, and the manufacturing facilities meet applicable requirements to ensure the continued safety, purity and potency of the product. (fda.gov)
  • But they manifest in ways that make products simply easier for us as emotional irrational humans to love (or at least makes it easier to occasionally forgive them). (uxmag.com)
  • The cars themselves aren't evolving, but the decisions made by humans about the design of them is what is actually starting to show biological adaptation and mutation. (dezeen.com)
  • A potential biological control agent - H39, based on a particular strain of the fungus Cladosporium - has been tested in several European field trials during the last two years. (wur.nl)
  • A biological control company is currently evaluating the possible commercial use of the H39 antagonist. (wur.nl)
  • The next step is to develop H39 into a commercial biological control product. (wur.nl)
  • Absorbent Products & Supplies, Pumps, Spill Control Equipment Well Products. (enviroyellowpages.com)
  • The Secretary may prohibit or restrict the importation, entry, exportation, or movement in interstate commerce of any plant, plant product, biological control organism, noxious weed, article, or means of conveyance, if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States or the dissemination of a plant pest or noxious weed within the United States. (house.gov)
  • The use of these three biological antagonists, recommends their use in the control of rot in post harvest yam tubers. (academicjournals.org)
  • Results on new substances with antimicrobic properties and alternative methods for the control of biological growth are presented as well. (nhbs.com)
  • Increasing focus on discovery of heat labile or temperature sensitive products, advanced biopharmaceutical research in medicine, and invention of effective means to treat various diseases are expected to boost the growth of the biological product manufacturing market. (sbwire.com)
  • This designation provides the Company with eligibility to obtain 12 years of market exclusivity upon approval of the product for commercial use by the FDA. (pharmiweb.com)
  • Are the biologic development requirements different than the requirements for a new drug product? (fda.gov)
  • The Secretary shall prescribe requirements under which a biological product undergoing investigation shall be exempt from the requirements of paragraph (1). (cornell.edu)
  • If your product is a non-viable preserved animal specimen, you won't need a permit to import it - as long as you meet the requirements in the IHS. (mpi.govt.nz)
  • Use our Product Finder to view and compare products that meet your specific requirements. (biotek.com)
  • Please refer to the datasheet enclosed in the product purchased before use. (ibl-japan.co.jp)
  • Please refer to a datasheet of each product. (ibl-japan.co.jp)
  • The definition is context-dependent, and can refer to the biological target of a pharmacologically active drug compound, the receptor target of a hormone (like insulin), or some other target of an external stimulus. (wikipedia.org)
  • This organic product is OMRI listed, and is safe for people and pets when used as directed. (westfield.com)
  • Our biological cleaning products include the ever-popular Bio Blocks and Blu Away for clean and efficient washrooms, the Royal Flush range for portable toilets and washrooms, the powerful Micro Clean treatment for organic soiling, and a variety of drainage and waste system treatments. (bio-productions.com)