Biological products. Medical search

Complex pharmaceutical substances, preparations, or matter derived from organisms usually obtained by biological methods or assay.

Laws concerned with manufacturing, dispensing, and marketing of drugs.

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.

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.

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.)

Infections with viruses of the genus PESTIVIRUS, family FLAVIVIRIDAE.

The presence of organisms, or any foreign material that makes a drug preparation impure.

The process of protecting various samples of biological material.

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.

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.

Substances added to pharmaceutical preparations to protect them from chemical change or microbial action. They include ANTI-BACTERIAL AGENTS and antioxidants.

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.

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.

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.

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)

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.

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 dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use.

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.

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.

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.

The sequence of PURINES and PYRIMIDINES in nucleic acids and polynucleotides. It is also called nucleotide sequence.

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.

Treatment of diseases with biological materials or biological response modifiers, such as the use of GENES; CELLS; TISSUES; organs; SERUM; VACCINES; and humoral agents.

Body of knowledge related to the use of organisms, cells or cell-derived constituents for the purpose of developing products which are technically, scientifically and clinically useful. Alteration of biologic function at the molecular level (i.e., GENETIC ENGINEERING) is a central focus; laboratory methods used include TRANSFECTION and CLONING technologies, sequence and structure analysis algorithms, computer databases, and gene and protein structure function analysis and prediction.

ATPases that are members of the AAA protein superfamily (ATPase family Associated with various cellular Activities). The NSFs functions, acting in conjunction with SOLUBLE NSF ATTACHMENT PROTEINS (i.e. SNAPs, which have no relation to SNAP 25), are to dissociate SNARE complexes.

Guanosine cyclic 3',5'-(hydrogen phosphate). A guanine nucleotide containing one phosphate group which is esterified to the sugar moiety in both the 3'- and 5'-positions. It is a cellular regulatory agent and has been described as a second messenger. Its levels increase in response to a variety of hormones, including acetylcholine, insulin, and oxytocin and it has been found to activate specific protein kinases. (From Merck Index, 11th ed)

A detailed review and evaluation of selected clinical records by qualified professional personnel for evaluating quality of medical care.

A clear, odorless, tasteless liquid that is essential for most animal and plant life and is an excellent solvent for many substances. The chemical formula is hydrogen oxide (H2O). (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

The reduction or regulation of the population of noxious, destructive, or dangerous plants, insects, or other animals. This includes control of plants that serve as habitats or food sources for animal pests.

Use of naturally-occuring or genetically-engineered organisms to reduce or eliminate populations of pests.

The reduction or regulation of the population of noxious, destructive, or dangerous insects through chemical, biological, or other means.

Systems of agriculture which adhere to nationally regulated standards that restrict the use of pesticides, non-organic fertilizers, genetic engineering, growth hormones, irradiation, antibiotics, and non-organic ANIMAL FEED.

Chemicals used in agriculture. These include pesticides, fumigants, fertilizers, plant hormones, steroids, antibiotics, mycotoxins, etc.

Bugs of the family CIMICIDAE, genus Cimex. They are flattened, oval, reddish insects which inhabit houses, wallpaper, furniture, and beds. C. lectularius, of temperate regions, is the common bedbug that attacks humans and is frequently a serious pest in houses, hotels, barracks, and other living quarters. Experiments have shown that bedbugs can transmit a variety of diseases, but they are not normal vectors under natural conditions. (From Dorland, 27th ed; Borror, et al., An Introduction to the Study of Insects, 4th ed, p272)

Pesticides designed to control insects that are harmful to man. The insects may be directly harmful, as those acting as disease vectors, or indirectly harmful, as destroyers of crops, food products, or textile fabrics.

Exclusive legal rights or privileges applied to inventions, plants, etc.

Sequential operating programs and data which instruct the functioning of a digital computer.

A novel composition, device, or process, independently conceived de novo or derived from a pre-existing model.

Method of analyzing chemicals using automation.

Property, such as patents, trademarks, and copyright, that results from creative effort. The Patent and Copyright Clause (Art. 1, Sec. 8, cl. 8) of the United States Constitution provides for promoting the progress of science and useful arts by securing for limited times to authors and inventors, the exclusive right to their respective writings and discoveries. (From Black's Law Dictionary, 5th ed, p1014)

Computer-based representation of physical systems and phenomena such as chemical processes.

A plant genus of the family ONAGRACEAE. Members contain oenotheins.

Individuals responsible for various duties pertaining to the medical office routine.

Juvenile hormone analog and insect growth regulator used to control insects by disrupting metamorphosis. Has been effective in controlling mosquito larvae.

Infections with true tapeworms of the helminth subclass CESTODA.

A subclass of segmented worms comprising the tapeworms.

A plant genus of the family VIOLACEAE. Some species in this genus are called bouncing bet which is a common name more often used with SAPONARIA OFFICINALIS. Members contain macrocyclic peptides.

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)

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 ...

https://en.wikipedia.org/wiki/Biophilia_hypothesis

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. ...

https://en.wikipedia.org/wiki/Tungsten

1 IU is the biological equivalent of 25 ng cholecalciferol/ergocalciferol). In addition, for products intended for infants, the ... the product of the CYP2R1 human gene, and expressed by hepatocytes.[184] Once made, the product is released into the plasma, ... certain cheese and cheese products, flour products, infant formulas, many breakfast cereals, and milk.[137][138] ... "The Journal of Biological Chemistry. 248 (19): 6691-6. doi:10.1016/S0021-9258(19)43408-X. PMID 4355503.. ...

https://en.wikipedia.org/wiki/Vitamin_D

Seahawk Biosystems - diagnosis biosensor products. *Sionex - chemical and biological sensors. *Polychromix - material analysis ... In-Q-Tel functions partially in public; however, what products it has and how they are used is strictly secret.[12] According ...

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Plant Biological and Molecular Processes; Plant Diseases; Plant Genetic Resources, Genomics, and Genetic Improvement; Quality ... and Utilization of Agricultural Products; Rangeland, Pasture, and Forages; Soil Resource Management; Veterinary, Medical, and ...

https://en.wikipedia.org/wiki/Henry_A._Wallace_Beltsville_Agricultural_Research_Center

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. ...

https://en.wikipedia.org/wiki/Eosinophil_peroxidase

Since the product is perishable, producers must have immediate access to proper cold storage (e.g., a household refrigerator or ... Biological Reviews. 89 (2): 255-269. doi:10.1111/brv.12052. PMID 23855350. Albert, Stefan; Bhattacharya, Debashish; Klaudiny, ... "Value-added products from beekeeping. Chapter 6". Buttstedt, Anja; Moritz, Robin F. A.; Erler, Silvio (May 2014). "Origin and ... "Federal Government Seizes Dozens of Misbranded Drug Products: FDA warned company about making medical claims for bee-derived ...

https://en.wikipedia.org/wiki/Royal_jelly

"Approved Products - ACAM2000". www.fda.gov. Retrieved 2018-09-08. "Biological Threats". Emergent BioSolutions. Retrieved 2018- ... Smallpox is considered a biological threat. Biological agents are toxins or organisms that can cause illness or death in humans ... Exposure can come from an intentional biological terrorist attack, accidental release of the agent, or a natural accident. ... enhances the emergency preparedness of the United States against the use of smallpox as a dangerous biological weapon." The ...

https://en.wikipedia.org/wiki/ACAM2000

No biological tests confirm major depression. In general, investigations are not repeated for a subsequent episode unless there ... Gordon Duff (31 May 2006). "Updated prescribing advice for venlafaxine (Efexor/Efexor XL)". Medicines and Healthcare products ... Adolf Meyer put forward a mixed social and biological framework emphasizing reactions in the context of an individual's life, ... The biopsychosocial model proposes that biological, psychological, and social factors all play a role in causing depression. ...

https://en.wikipedia.org/wiki/Major_depressive_disorder

doi:10.1016/S0034-4257(99)00023-1. Battersby AR (December 2000). "Tetrapyrroles: the pigments of life". Natural Product Reports ... Biological Bulletin. 136 (1): 54-62. doi:10.2307/1539668. JSTOR 1539668. Gilpin L (21 March 2001). "Methods for analysis of ... Willows RD (June 2003). "Biosynthesis of chlorophylls from protoporphyrin IX". Natural Product Reports. 20 (3): 327-41. doi: ... Biological Chemistry. 383 (11): 1769-78. doi:10.1515/BC.2002.198. PMID 12530542. S2CID 3099209. Eckhardt U, Grimm B, ...

https://en.wikipedia.org/wiki/Chlorophyll

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. 70 (11): 1746-52. doi:10.1021/np0702483. PMID 17958395. Stewart, M; Capon, R. J.; Lacey, E; ...

https://en.wikipedia.org/wiki/Penicillium_striatisporum

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 ...

https://en.wikipedia.org/wiki/Setosphaeria_rostrata

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.. ...

https://en.wikipedia.org/wiki/Pulse_

Mann, J. C.; Hobbs, J. B.; Banthorpe, D. V.; Harborne, J. B. (1994). Natural Products: Their Chemistry and Biological ... bath products, and other personal care products.[1] D-Limonene is also used as a botanical insecticide.[1][14] D-Limonene is ... Limonene takes its name from French limon ("lemon").[3] Limonene is a chiral molecule, and biological sources produce one ... Limonene is common as a dietary supplement and as a fragrance ingredient for cosmetics products.[1] As the main fragrance of ...

https://en.wikipedia.org/wiki/Dipentene

"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] ...

https://en.wikipedia.org/wiki/Clinical_depression

The products are primarily marketed as biological and biochemical fertilizer catalysts that increase nutrient availability and ... In July 2012, Agricen entered a strategic partnership with Loveland Products, Inc., a provider of crop input products and part ... Loveland Products. Retrieved 7 January 2020. CS1 maint: discouraged parameter (link) Ruen, Jim (18 January 2017). "Biological ... Commercially available products in the United States include Accomplish LM, Extract Powered by Accomplish, Maritime, and Titan ...

https://en.wikipedia.org/wiki/Agricen

If the product being tested causes the endotoxin recovery to be less than expected, the product is inhibitory to the LAL test. ... Series B, Physical and Biological Sciences. 83 (4): 110-9. doi:10.2183/pjab.83.110. PMC 3756735. PMID 24019589. Zhang S (2018- ... In the United States, the FDA has published a guideline for validation of the LAL test as an endotoxin test for such products. ... Proper endotoxin recovery must be proven before LAL can be used to release product. The LAL test is a major source of animal ...

https://en.wikipedia.org/wiki/Limulus_amebocyte_lysate

The compound is the first natural product that has in vivo potential against the T. brucei. Cynaropicrin is a compound with ... Its γ-butyrolactone ring is involved in most of its biological functions. The unsaturated carbonyl group on the lactone ring ... On hydrogenation products of cynaropicrin, the bitter principle of artichoke (Cynara scolymus L.)". Collection of Czechoslovak ... Mander, Lewis N. Liu, Hung-wen, 1952- (2012). Comprehensive natural products II : chemistry and biology. Elsevier. ISBN 978-1- ...

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Washroom and Hygiene Products. Retrieved 2021-04-14. "Biological Safety: Disinfection , Office of Environmental Health and ... resistant products, such as Bayer AG's DK Excited Bacteriostatic agent Disinfectant Enveloped virus List of cleaning products# ... "List of cleaning products", Wikipedia, 2021-03-27, retrieved 2021-04-17 "Help & Support". www.lysol.com. Retrieved 2021-04-12 ... Disinfecting uses a chemical product, which is a process that kills the germs on the surfaces. In most situations, regular ...

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Dewick, P. (2009). Medicinal Natural Products: A Biosynthetic Approach (3rd ed.). West Sussex, England: Wiley. p. 357. ISBN 978 ... Chemico-biological Interactions. 293: 115-123. doi:10.1016/j.cbi.2018.07.022. PMID 30086269. ... Dewick, P. (2009). Medicinal Natural Products: A Biosynthetic Approach (3rd ed.). West Sussex, England: Wiley. p. 358. ISBN 978 ... Product 7 is then oxidized to form the methylenedioxy ring from the ortho-methoxyphenol, via an O2-, NADPH- and cytochrome P450 ...

https://en.wikipedia.org/wiki/Berberine

"The fluid dynamical context of chemosensory behavior." The Biological Bulletin 198 (2000): 188-202. Legrand, C, K Rengefors, GO ... Journal of Natural Products. American Chemical Society (ACS). 80 (5): 1287-1293. doi:10.1021/acs.jnatprod.6b00860. ISSN 0163- ... The Biological Bulletin. 198 (2): 225-244. CiteSeerX 10.1.1.317.7878. doi:10.2307/1542526. JSTOR 1542526. PMID 10786943. ... Shimizu Excreted toxins may help deter predators and bacteria which are drawn in by phytoplankton waste products. Phytoplankton ...

https://en.wikipedia.org/wiki/Phycotoxin

"Systematic conservation planning products for land-use planning: Interpretation for implementation". Biological Conservation. ... One product of this initial cycle is the report "Integrating the Alaska Landscape into the Future." The project uses a climate ... Within 18 months of producing these products, the evidence that maps and their guidelines are effectively integrated or ... Therefore, people must develop systematic (target-driven) protection planning products that are both user-friendly and useful ...

https://en.wikipedia.org/wiki/Landscape_conservation_cooperatives

Journal of Biological Chemistry. 264 (20): 11744-11749. Dewick, Paul M (2009). Medicinal Natural Products: a biosynthetic ...

https://en.wikipedia.org/wiki/Spermine

Masters, Bettie Sue Siler (2009-07-24). "A Professional and Personal Odyssey". Journal of Biological Chemistry. 284 (30): 19765 ... Mosbach, K. (1969). "Biosynthesis of Lichen Substances, Products of a Symbiotic Association". Angewandte Chemie International ...

https://en.wikipedia.org/wiki/Klaus_Mosbach

Other biological functions for which CSGAGs are known to play critical functions in include inhibition of axonal growth and ... 2002). "Heparin and heparan sulfate: structure and function". Natural Product Reports. 19 (3): 312-331. doi:10.1039/B100916H. ... It is believed that through differences in enzyme activity and expression, the wide spectrum of biological functions mediated ... Heparan sulfate (HS) has numerous biological activities and functions, including cell adhesion, regulation of cell growth and ...

https://en.wikipedia.org/wiki/Glycosaminoglycan

... household product ingredient, industrial additive, personal care product/cosmetic ingredient, pesticide ingredient, plastic/ ... Burton G. W., Ingold K. U. (1981). "Autoxidation of biological molecules. 1. Antioxidant activity of vitamin E and related ... Household Products Database. [2] Archived 2015-09-05 at the Wayback Machine.US EPA. InertFinder. [3]. US National Library of ... Some food companies have voluntarily eliminated BHT from their products or have announced that they were going to phase it out ...

https://en.wikipedia.org/wiki/Butylated_hydroxytoluene

Natural Product Letters. 6 (3): 181-185. doi:10.1080/10575639508043156. Kim, J.-C.; Choi, G. J.; Park, J.-H.; Kim, H. T.; Cho, ... Agricultural and Biological Chemistry. 55 (8): 2037-2042. doi:10.1080/00021369.1991.10870928. Harwooda, John S.; Cutler, Horace ... Journal of Asian Natural Products Research. 11 (11): 962-6. doi:10.1080/10286020903339614. PMID 20183261. Hudson, H. J. ( ...

https://en.wikipedia.org/wiki/Nigrospora_sphaerica

Loring HS (1939). "Properties and hydrolytic products of nucleic acid from tobacco mosaic virus". Journal of Biological ... Biological Reviews of the Cambridge Philosophical Society. 79 (4): 911-33. doi:10.1017/S1464793104006505. PMID 15682876. Curtis ...

https://en.wikipedia.org/wiki/History_of_virology

... is a sesquiterpene lactone natural product derived from various plant sources including Salvia sclarea, Salvia ... Isolation of norambreinolide from cigar tobacco". Agricultural and Biological Chemistry. 35 (9): 1461-1462. doi:10.1080/ ... Journal of Natural Products. 59 (2): 113-116. doi:10.1021/np960028h. CS1 maint: discouraged parameter (link) Kaneko, Hajime ( ...

https://en.wikipedia.org/wiki/Sclareolide

"Introduction to Biological Safety Cabinets". Retrieved April 26, 2010.. *^ a b DePalma, Angelo (October 7, 2009). "Product ... American Biological Safety Association (December 2000). "Position Paper on the Use of Ultraviolet Lights in Biological Safety ... A biosafety cabinet (BSC)-also called a biological safety cabinet or microbiological safety cabinet-is an enclosed, ventilated ... The CDC does not recommend the installation of UV lamps in BSCs.[3]:12-13 The American Biological Safety Association supports ...

https://en.wikipedia.org/wiki/Biosafety_cabinet

425 per product up to fifty products and a maximum of $20,000 per company.[4] For each product over fifty, the fee is $100, for ... limitations when the Fish and Wildlife service express a potential adverse effect on a particular species based on a biological ... Registration of pesticide productsEdit. Before a company can register its pesticide products with the EPA, it must know what ... If this NOA is not complete the product would not make it through customs. The NOA lists the identity of the product, the ...

https://en.m.wikipedia.org/wiki/Federal_Insecticide,_Fungicide,_and_Rodenticide_Act

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 ...

https://en.wikipedia.org/wiki/Food_web

"Brazilian Journal of Medical and Biological Research = Revista Brasileira de Pesquisas Medicas e Biologicas. 39 (8): 1065-70. ... As a result, structural proteins, resulting from polypeptide products of gag and gag-pol genes, that are necessary for the HIV ...

https://en.wikipedia.org/wiki/Indinavir

... includes not just the use of plant products, but may also include the use of animal and mineral products.[74] It is among the ... that has a biological or psychological effect on a patient may also have potential to possess dangerous biological or ... animal and fungal products, and minerals, including use of these products in traditional medical practices that may also ... FDA, Use Caution With Ayurvedic Products *^ Niggemann, B.; Grüber, C. (22 February 2003). "Side-effects of complementary and ...

https://en.wikipedia.org/wiki/Integrative_medicine

"β-Catenin". Sino Biological Inc.: Biological Solution Specialist. Reynolds AB (June 2011). "Epithelial organization: new ... These gene products are important in determining cell fates during normal development and in maintaining homeostasis, or they ... a tumor suppressor gene product), CSNK1A1, and GSK3B. Following phosphorylation of the N-terminal Ser and Thr residues of β- ...

https://en.wikipedia.org/wiki/Catenin

Gurib-Fakim, A.; Subratty, H.; Narod, F.; Govinden-Soulange, J.; Mahomoodally, F.. «Biological activity from indigenous ... Industrial Crops and Products. doi:10.1016/j.indcrop.2015.03.058. ... Biological & Pharmaceutical Bulletin. doi:10.1248/bpb.27.1814. ... Biological & Pharmaceutical Bulletin. doi:10.1248/bpb.27.216. ...

https://el.wikipedia.org/wiki/Αμινά_Γκουρίμπ

Biological decomposition accelerates and the microbiota mass increases at the expense of other organic matter, adversely ... The Rishi Kheti use cow products like buttermilk, milk, curd and its waste urine for preparing growth promoters. The Rishi ... Ladybirds consume aphids and are considered beneficial by natural farmers that apply biological control. ...

https://en.m.wikipedia.org/wiki/Natural_farming

... to analyze complex biological systems. QIAGEN Silicon Valley's first product, IPA, was introduced in 2003, and is used to help ... Resulting information can be used to build biological models, design experiments, or get up to speed in an area of research. ... "New Products: Randox Laboratories' Beta-Lactams Array; Ingenuity Systems' iReport". BioArray News. GenomeWeb. January 24, 2012 ... All QIAGEN Silicon Valley use the Ingenuity Knowledge Base, which contains biological and chemical interactions and functional ...

https://en.wikipedia.org/wiki/QIAGEN_Silicon_Valley

The Madagascan periwinkle Catharanthus roseus L. is the source for a number of important natural products,[1] including ... "Synthesis and biological evaluation of Vinca alkaloids and phomopsin hybrids". Journal of Medicinal Chemistry. 52 (1): 134-142 ... Sears, Justin E.; Boger, Dale L. (2015). "Total Synthesis of Vinblastine, Related Natural Products, and Key Analogues and ... "Recent applications of Cp2TiCl in natural product synthesis". Organic Chemistry Frontiers. 1 (1): 15-33. doi:10.1039/c3qo00024a ...

https://en.wikipedia.org/wiki/Vinca_alkaloids

"Proceedings of the Royal Society B: Biological Sciences. 276 (1654): 121-127. doi:10.1098/rspb.2008.0858. PMC 2614250. PMID ... The products of photosynthesis are called "assimilates". In ferns and most flowering plants, the mesophyll is divided into two ... Specialized cells that differ markedly from surrounding cells, and which often synthesize specialized products such as crystals ... minor veins collect the products of photosynthesis (photosynthate) from the cells where it takes place, while major veins are ...

https://en.m.wikipedia.org/wiki/Cauline

Blood products such as packed red blood cells, platelets, or fresh frozen plasma may also be used.[135] Other regulators of ... May 2002). "Hemorrhagic fever viruses as biological weapons: medical and public health management". Journal of the American ... "FDA warns consumers about fraudulent Ebola treatment products" (Press release). Archived from the original on 11 January 2017. ... In late 1989, Hazelton Research Products' Reston Quarantine Unit in Reston, Virginia, suffered an outbreak of fatal illness ...

https://en.m.wikipedia.org/wiki/Ebola_virus_disease

The Thatcher filing was then followed by an FDA filing by BRC Operations PTY Limited, with their BRC Software Product[8] in ... Neural network (biological). *Detection theory. *Intraoperative neurophysiological monitoring. *Neurochip. *Neurodegeneration. ...

https://en.wikipedia.org/wiki/Neurometrics

... the body of literature that used these approaches seem to have mistaken and interpreted mathematical artifacts as the products ...

https://en.wikipedia.org/wiki/DunningKruger_effect

"Cooking as a biological trait" (PDF). Comp Biochem Physiol a Mol Integr Physiol. 136 (1): 35-46. doi:10.1016/S1095-6433(03) ...

https://en.wikipedia.org/wiki/Paleolithic

Examples of these classifications include gender, nationality, ethnicity, language, genre, style, biological species, and form. ... I found that they formed invariant products of not one but two distinct kinds. ... The first group of limits were calculable a ...

https://en.wikipedia.org/wiki/Numerical_data

Series B, Biological Sciences. 365 (1541): 729-48. doi:10.1098/rstb.2009.0103. PMC 2817223. PMID 20124341.. ... Curiously, around half of the protein products of transferred genes aren't even targeted back to the chloroplast. Many became ... The Journal of Biological Chemistry. 271 (11): 6545-54. doi:10.1074/jbc.271.11.6545. PMID 8626459.. ... Some transferred chloroplast DNA protein products get directed to the secretory pathway[27] (though many secondary plastids are ...

https://en.m.wikipedia.org/wiki/Chloroplast_DNA

In this context, it is the current state of humanity's knowledge of how to combine resources to produce desired products, to ... including the possibility of the permanent alteration of our biological nature. These concerns are shared by other philosophers ... Many technological processes produce unwanted by-products known as pollution and deplete natural resources to the detriment of ... "New products, new industries, and more jobs require continuous additions to knowledge of the laws of nature ... This essential ...

https://en.m.wikipedia.org/wiki/Technological

Biomechanics is the study of the structure and function of biological systems by means of the methods of Mechanics. ... Throughout history and in Europe right until the late 18th century, not only animal and plant products were used as medicine, ... Biophysics is an interdisciplinary science that uses the methods of physics and physical chemistry to study biological systems. ... Histology is the study of the structures of biological tissues by light microscopy, electron microscopy and ...

https://en.wikipedia.org/wiki/Medical

The maximum value of U is the product of the sample sizes for the two samples. In such a case, the "other" U would be 0. ... Biological Reviews of the Cambridge Philosophical Society. 82 (4): 591-605. doi:10.1111/j.1469-185X.2007.00027.x. PMID 17944619 ...

https://en.wikipedia.org/wiki/Mann-Whitney_U_test

"Progress in Clinical and Biological Research. 337 (7070): 301-7. doi:10.1136/bmj.313.7070.1450. PMC 2352989. PMID 8973234.. ... The same law also made it illegal to advertise cigarettes or other tobacco products.[48] ... Explained ] The Cigarettes And Other Tobacco Products (Prohibition Of Advertisement And Regulation Of Trade And Commerce, ... and radioactive decay products, such as polonium-210.[12] Several well-established carcinogens have been shown by the tobacco ...

https://en.wikipedia.org/wiki/Anti-smoking_legislation

... biological) material. Specifically, diagenesis "is the cumulative physical, chemical and biological environment; these ... This transformation occurs in the first few hundred meters of burial and results in the creation of two primary products: ... or biological change undergone by a sediment after its initial deposition, after its lithification. This process excludes ...

https://en.wikipedia.org/wiki/Diagenesis

"Brazilian Journal of Medical and Biological Research = Revista Brasileira de Pesquisas Medicas e Biologicas. 40 (4): 443-56. ... a product should be sprayed on the tick to cause it to freeze and then drop off.[142] A doctor would use liquid nitrogen, but ... Newby, Kris (2019). Bitten: the Secret History of Lyme Disease and Biological Weapons. HarperCollins. ISBN 9780062896278. .. ... epidemiologist Jorge Benach provided Willy Burgdorfer, a researcher at the Rocky Mountain Biological Laboratory, with ...

https://en.wikipedia.org/wiki/Lyme_disease

"Proceedings of the Royal Society B: Biological Sciences. 278 (1708): 1090-1097. doi:10.1098/rspb.2010.1579. PMC 3049027. PMID ... Humans' extensive 'technosphere', now reaches ~30 Tt, including waste products from non-renewable resources.. ... "Secretariat of the Convention on Biological Diversity. Retrieved 9 January 2017.. *^ Glowka, Lyle; Burhenne-Guilmin, Françoise ... We have driven the rate of biological extinction, the permanent loss of species, up several hundred times beyond its historical ...

https://en.m.wikipedia.org/wiki/Sixth_mass_extinction

Product[edit]. Processing[edit]. A combination of gravity, screens and air flow is used to clean and sort lentils based on ... Biological nitrogen fixation or other rotational effects could be the reason for higher yields after lentils.[11] ...

https://en.wikipedia.org/wiki/Lentils

"ASTM Products and Services. Retrieved 15 June 2014.. *^ a b "ASTM F3208 - 17 Standard Guide for Selecting Test Soils for ... "11.100.20: Biological evaluation of medical devices". Retrieved 10 April 2009.. *^ International Organization for ... "ASTM International Products and Services. Retrieved 15 June 2014.. *^ "Standard Practice for Reporting and Assessment of ... "ASTM International - Products and Services. Retrieved 15 June 2014.. *^ "Standard Guide for Blood Cleaning Efficiency of ...

https://en.m.wikipedia.org/wiki/Medical_device

Lithium naturally only occurs in traces in biological systems and has no known biological role, but does have effects on the ... Francium-223, the only naturally occurring isotope of francium,[58][59] is the product of the alpha decay of actinium-227 and ... Biological role and precautionsEdit. MetalsEdit. Pure alkali metals are dangerously reactive with air and water and must be ... Rubidium has no known biological role, but may help stimulate metabolism,[234][235][236] and, similarly to caesium,[234][237] ...

https://en.m.wikipedia.org/wiki/Alkali_metal

The three major histatins are 1, 3, and 5. Histatin 2 is a degradation product of histatin 1, and all other histatins are ... "The Journal of Biological Chemistry. 263 (16): 7472-7477. ISSN 0021-9258. PMID 3286634.. .mw-parser-output cite.citation{font- ... degradation products of histatin 3. Therefore there are only two genes, HTN1 and HTN3. ...

https://en.wikipedia.org/wiki/Histatin

Earthjustice, the Sierra Club, the Center for Biological Diversity and other environmental groups announced a campaign in 2015 ... Products. Coal. Revenue. $ 4.2 billion (FY 2012)[2]. Operating income. $ (682) million (FY 2012)[2]. ...

https://en.wikipedia.org/wiki/Arch_Coal

Biological data visualization. *Chemical imaging. *Crime mapping. *Data visualization. *Educational visualization. *Flow ... Product visualization. *Scientific visualization. *Software visualization. *Technical drawing. *User interface design. *Visual ...

https://en.wikipedia.org/wiki/Computer_graphics_

These differences probably reflect some biological differences as well as differences in pathologic diagnosis and reporting.[51 ... More generally a neoplasm may cause release of metabolic end products (e.g., free radicals, altered electrolytes, ...

https://en.m.wikipedia.org/wiki/Brain_tumors

... 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 ...

http://www.aabb.org/advocacy/regulatorygovernment/ct/biologicalproducts/Pages/default.aspx

... 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 ...

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm

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.. ...

https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm120262.htm

A) 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" defined. In 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 ... 4) The term "reference product" means the single biological product licensed under subsection (a) against which a biological ...

https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim

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 ...

http://www.nsf.org/training-education/training-entry/2019868-gmp-for-biological-and-biotechnology-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 ...

https://www.springer.com/gp/book/9783319596884

BioPro Ireland products and equipment for Water Treatment. Including August BioPro - Model ATCP & AT Series - Small Residential ... All Products Services Software Training Applications Companies News Articles Books Magazines Events Downloads Videos ... August-BioPro - Model AT-75 to AT-400 - Group Schemes and Commercial for Biological Reactors. ... Group schemes and commercial applications use the AT-75 to AT-400 biological reactors. The larger bio-reactors consist of ...

https://www.environmental-expert.com/companies/biopro-ireland-49833/products/family-biological-wastewater-treatment-plants-245515

... any such complex product of organic or synthetic origin obtained or standardized by biological methods or assay (such as ... Biological product definition is - a complex pharmaceutical substance, preparation, or agent of organic origin depending for ... Share biological product. Post the Definition of biological product to Facebook Share the Definition of biological product on ... "Biological product." Merriam-Webster.com Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/biological% ...

https://www.merriam-webster.com/dictionary/biological%20product

Free Shipping and expert advice on a wide range of do it yourself pest control products, pest control supplies, pest control ...

https://www.domyownpestcontrol.com/koppert-biological-systems-m-190.html?features%255B10%255D=10&features%255B12%255D=12&features%255B11%255D=11&page=3

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 ...

https://www.federalregister.gov/documents/2004/12/29/04-28322/biological-products-bacterial-vaccines-and-toxoids-implementation-of-efficacy-review

View products and services from Yunnan Yuanjiang Evergreen Biological Industry (Group) Co., Ltd. in their PR.com company ... Yunnan Yuanjiang Evergreen Biological Industry (Group) Co., Ltd. Yunnan Yuanjiang Evergreen Biological Industry (Group) Co., ... Product. We are the largest aloe vera raw materials manufacturer in Asia. We are engrossed in integrated supply of raw Aloe ... Product. We are the largest aloe vera raw materials manufacturer in Asia. We are engrossed in integrated supply of raw Aloe ...

https://www.pr.com/company-profile/products-services/3786

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 ...

http://www.freepatentsonline.com/y2009/0248317.html

... 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. ...

https://www.federalregister.gov/documents/2013/11/13/2013-26799/supplemental-applications-proposing-labeling-changes-for-approved-drugs-and-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 ...

https://marketpublishers.com/report/medicine_pharmaceuticals_biotechnology/drugs_biotechnology/china_biological_biochemical_products_market_report.html

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 ...

https://www.environmental-expert.com/articles/keyword-septic-tank-biological-product-26968

Compare Anti-NFASC Antibody Products from Sino Biological, Inc. from leading suppliers on Biocompare. View specifications, ... Selected Products. You havent selected any products. Find products. Stay up to date on news and special offers related these ... Anti-NFASC Antibody Products from Sino Biological, Inc.. Anti-NFASC antibodies are offered by a number of suppliers. This ... Biocompare is the leading resource for up-to-date product information, product reviews, and new technologies for life ...

https://www.biocompare.com/pfu/110447/soids/313123/Antibodies/NFASC?vids=104292

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 ...

http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353&num=0&edition=prelim

Find China Product Listings in Alphabetical Order on Alibaba.com for China Naturals Big, China Naturals Biological, China ... Browse Products Alphabetically: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 ... China Naturals Biological. China Naturals Biology. China Naturals Black. China Naturals Blue. China Naturals Blues. China ... Browse by:Manufacturers - Online Shopping - China Gold Suppliers - All Products - Countries - Importers - Buying Leads - China ...

http://www.alibaba.com/countrysearch/CN/China/products/N_709.html

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 ...

https://www.valent.com/agriculture/products/dipel/index.cfm

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, ...

http://www.amamanualofstyle.com/view/10.1093/jama/9780195176339.001.0001/med-9780195176339-div2-411?rskey=yaJWjV&result=1&q=

"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 ...

https://www.morganlewis.com/pubs/healthcare-reform-law-a-new-regulatory-pathway-for-biosimilar-biological-products

... - a Short Review. ... Please select your country so we can show you products that are available for you. ...

https://www.sartorius.com/en/pr/cell-culture/sartorius-ultrafiltration-products-in-the-preparation-of-biological-and-medical-nanocarriers

A method of producing a recombinant biological product, which method employs a mammalian producer cell culture, comprises the ... Method of producing recombinant biological products. A method of producing a recombinant biological product, which method ...

https://www.ideaconnection.com/patents/15893-Method-of-producing-recombinant-biological-products.html?c=37

... from Divex Oxygen Compatible CleanerBiox Biological Cleaner ... More Divex Products. *Stealth Dual Mode Mask Products. Stealth Dual Mode Mask products from Divex Full Face Mask Fitted With An ... More Diving Products from Other Companies. *Stealth Dual Mode Mask Products. Stealth Dual Mode Mask products from Divex Full ... More Divex Products More Diving Products from Other Companies Top Diving Companies Jobs related to Diving products ...

https://www.subsea.org/biox-biological-cleaner-products/

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 ...

https://www.law.cornell.edu/uscode/text/42/262

... substantial disruption or inactivation of cells and without significant loss of labile proteins or other valuable biological ... The present invention concerns the product produced by inactivating extracellular or intracellular pathogenic virus in a ... biological composition, or biological fluid obtained by the inventive method be an in vitro produced product, but will be ... said biological composition comprising at least one of a cell-containing biological composition and a biological fluid ...

http://www.google.com/patents/US6548242?dq=6446111

The subject of the invention is an elastin-based product consisting of an adduct containing elastin and at least one protein ... Elastin-based product, a procedure for its preparation and its biological applications; in particular as biomaterials and ... The invention also relates to a procedure for its preparation as well as to the biological applications of this product, in ... In the remainder of the text, the products thus prepared will also designated by the special description of biological patch. ...

http://www.google.co.uk/patents/US5223420

Fly Eliminators® - Biological Fly Control * How To Build Your Fly Control Program ...

https://www.arbico-organics.com/?a=2016

Development of mineral membranes and processes for separating biological fermentation products. New process for the preparation ... Development of a new process for the preparation of pharmaceutical products of fermentation, based on the use of new mineral ... of pharmaceutical products. of fermentation, based on new mineral membranes. characterised by their separating capacity ...

https://www.eurekanetwork.org/project/id/160

Predictive Analyses of Biological Effects of Natural Products: From Plant Extracts to Biomolecular Laboratory and Computer ... Roberto Gambari, "Predictive Analyses of Biological Effects of Natural Products: From Plant Extracts to Biomolecular Laboratory ...

https://www.hindawi.com/journals/ecam/2011/383290/cta/

The new chapter addresses the specific challenges of pharmacovigilance relating to biological medicinal products. (lexology.com)
The chapter entitled " Product- or population-specific considerations II: Biological medicinal products " ("the Chapter") came into effect on 16 August 2016. (lexology.com)
The Chapter applies to all biological medicinal products (reference products, biosimilars and related products) except for vaccines and advanced therapy medicinal products. (lexology.com)
The Chapter is intended to be read alongside process-related GVP Modules that apply to all medicinal products, and highlights specific issues to be taken into account when monitoring and managing the safety of biological medicinal products post-authorisation. (lexology.com)
The Chapter outlines the roles and responsibilities of marketing authorisation holders, competent authorities and the EMA on how to better monitor and manage the safety of biological medicinal products. (lexology.com)
The particular risk areas identified in the Chapter that relate to biological medicinal products are immunogenicity, manufacturing variability, non-adherence to good distribution practices and product traceability. (lexology.com)
While all medicinal products have the potential to cause immunogenicity, the risk is greater for biological medicinal products and requires specific consideration. (lexology.com)
The Chapter provides that pre-marketing authorisation studies on biological medicinal products cannot usually adequately assess the risk of immunogenicity arising from all of these factors. (lexology.com)
The manufacturing variability risks relates to the fact that minor variations at various stages of the manufacturing process of biological medicinal products (such as changes in choice of cell line, starting materials, fermentation, purification) can have a significant effect on product quality, safety and efficacy. (lexology.com)
The safety of biological medicinal products may change over time for the same product, and the quality assessment of reference products may differ from that of biosimilars and related products. (lexology.com)
Quality of biological medicinal products may also differ between specific batches as a consequence of standards specified at later stages of the supply chain not being properly complied with such as storage and handing conditions, cold chain and good distribution practices. (lexology.com)
The Chapter further provides that non-adherence to appropriate storage and handling conditions, cold chain and good distribution practices may affect the stability and quality of biological medicinal products, which in turn may introduce or alter immunogenicity or contamination. (lexology.com)
Life-cycle pharmacovigilance is therefore an important aspect for biological medicinal products. (lexology.com)
Another key requirement for pharmacovigilance of biological medicinal products identified in the Chapter is the need to ensure continuous product and batch traceability in clinical use. (lexology.com)
The term "generic" medicine is used to describe chemical, small molecule medicinal products that are structurally and therapeutically equivalent to an originator product whose patent and/or data protection period has expired. (who.int)
The distribution of medicinal products has called the attention of the regulators worldwide. (gmp-compliance.org)
This document is an annex to the guideline on similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues . (europa.eu)
It lays down the non-clinical and clinical requirements for somatropin-containing medicinal products claiming to be similar to another one already marketed. (europa.eu)

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)

Whereas a new drug application (NDA) is used for drugs subject to the drug approval provisions of the FDC Act, a biologics license application (BLA) is required for biological products subject to licensure under the PHS Act. (fda.gov)
The repackaging of biological products not subject to licensure under section 351 is addressed in a separate draft guidance document. (gmp-compliance.org)

However, only biological products are licensed under section 351 of the PHS Act. (fda.gov)
Reference product" is defined as the single biological product licensed under Section 351, Subsection (a) of the PHS Act against which a biological product is evaluated. (morganlewis.com)
Within this draft document, FDA shows their policy regarding the mixing, diluting, and repackaging of certain types of biological products that have been licensed under section 351 of the Public Health Service Act (PHS Act) when such activities are not within the scope of the product's approved biologics license application (BLA) as described in the approved labelling for the product. (gmp-compliance.org)

If the clinical studies in humans demonstrate the biological product is safe and effective and the relative benefits outweigh the risks, the sponsor may pursue licensure by submitting a Biologics License Application (BLA). (aabb.org)
The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), establishes an abbreviated licensure pathway for biosimilar biological products, with provisions covering exclusivity periods, and payment for biosimilars. (morganlewis.com)
42 U.S.C. Section 262), which provides the statutory framework for Biologics License Applications (BLAs) to allow licensure of biological products as biosimilar or interchangeable. (morganlewis.com)
This guideline can be adopted as a whole, or partially, by NRAs worldwide or used as a basis for establishing national regulatory frameworks for licensure of these products. (who.int)

What's less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market. (raps.org)
LAMPIRE Biological Laboratories specializes in polyclonal and monoclonal antibody development, cell culture devices and services, and a wide variety of blood-derived products. (lampire.com)
LAMPIRE Biological Laboratories, Inc., announced it has completed the acquisition of H. B. Custom Media, based out of the Ben Franklin Tech Ventures Business Center, in Bethlehem, PA. (lampire.com)
In that moment, life sciences company Lampire Biological Laboratories Inc. had found its name. (lampire.com)
Global Bovine Serum Albumin Market Top Players 2017: Lampire Biological Laboratories. (lampire.com)
However, many laboratories have limited resources for biological evaluation, leaving their previously isolated or synthesized compounds largely or completely untested. (ucsd.edu)
Immuno-Biological Laboratories Co., Ltd. (ibl-japan.co.jp)

Most wastewater treatment processes produce a by-product that purifies wastewater before it is released into local waterways. (environmental-expert.com)
This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. (iso.org)
It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure. (iso.org)
This is due to the complexity of biological active substance molecules, and complexity of manufacturing processes with many steps that can each have an effect on product quality and safety. (lexology.com)
This Kat is grateful to his colleague Andrew Sharples , head of practice group EIP Life , for preparing this report of recent news from the European Patent Office about the patentability of products of essentially biological processes. (blogspot.com)
This decision did not go unnoticed by the powers of the EU, and in December 2015, the European Parliament adopted a resolution asking the European Commission to look into the patentability of products of essentially biological processes. (blogspot.com)
Nevertheless, the Commission has concluded that animals and plants derived from essentially biological processes should not be patentable. (blogspot.com)
Processes for importing products, organisms, or animals related to biological products are set out elsewhere on this website. (mpi.govt.nz)
Here the EBA conducted a lengthy and in-depth legal analysis leading to the conclusion that a narrow interpretation of Art 53(b) EPC was appropriate and as a result plants and animals derived from essentially biological processes were in principle patentable, even if they were inevitably derived from such processes. (blogspot.com)
The exclusion to patentability in the Biotech Directive is framed much like that in Article 53(b) EPC i.e. it expressly excludes from patentability essentially biological processes for the production of plants and animals but does not mention products derived from such processes. (blogspot.com)
The processes of freezing a formulation, followed by sublimation of the solvent to produce a lyo-cake, is extremely complicated, and demands further investigation of formulation design, stability, cycle development, and process scale-up to produce the highest quality lyo-product. (europeanpharmaceuticalreview.com)
BS EN ISO 11138-5:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent. (bsigroup.com)
This project will research a treatment concept for the removal of PPPs that is new to greenhouse horticulture and which is based on two processes: biological treatment and adsorption. (kwrwater.nl)
The project's researchers will focus on the applicability in horticulture of physical/chemical and biological processes from water technology. (kwrwater.nl)

Both the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, including premarket review and oversight. (fda.gov)
Please refer to the Transfer of Therapeutic Biological Products to the Center for Drug Evaluation and Research for updates that further define the categories of biological products that are regulated by CDER and CBER. (fda.gov)
For information concerning human drug products: Audrey A. Thomas, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5625. (fda.gov)
For information concerning human biological products: Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-594-3074. (fda.gov)
The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) on Wednesday released its annual summary of manufacturing deviations reported by biologics, blood and blood component, and human cells, tissues, and cellular and tissue-based products (HCT/P) manufacturers. (raps.org)
Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). (who.int)

This category includes therapeutic proteins derived from plants, animals, humans, or microorganisms, and recombinant versions of these products. (fda.gov)
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)
A method of producing a recombinant biological product, which method employs a mammalian producer cell culture, comprises the steps of generating a biomass of mammalian producer during an initial phase of cell culture, and causing an increase in a level of one or more of the miRNA molecules of Table 1 within the mammalian producer cells once a desired concentration of mammalian producer cells has been achieved. (ideaconnection.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)

This statistic shows the direct export value of biological products from Taiwan between 2008 and 2017. (statista.com)
In 2017, the direct export value of biological products from Taiwan had amounted to approximately 598.29 million New Taiwan dollars. (statista.com)
At the end of June the EPO published a notice (see here ) stating from 1 July 2017 plants and animals exclusively obtained by means of an essentially biological process will no longer be patentable. (blogspot.com)
Albany, NY -- ( SBWIRE ) -- 06/12/2017 -- Biological products or biologics are therapeutic preparations that consist of natural complex biomolecules derived from living things. (sbwire.com)

Seed treatment products based on a biological fungicide, give immediate protection against diseases. (koppert.com)

For these HCT/Ps regulated as biological products, the FDA requires premarket review of safety and efficacy data before these cellular therapy products are introduced into commercial market. (aabb.org)

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)
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)

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)
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)

The product indicated as " Research reagents " in the column Intended Use cannot be used for diagnostic nor any medical purpose. (ibl-japan.co.jp)

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)
Biological treatment has long been used in the treatment of wastewater. (kwrwater.nl)

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)
In terms of product type, the market is classified into bio-pharmaceutical products and biotechnological/biological products. (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)
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)
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)

In addition, the fermentation products wine and vinegar showed a similar nutritional composition that were present at a higher concentration than in juice, which indicated that fermentation helps in the dissolution of nutrient substances, while the thermal processing products dried slices and jam showed a similar nutritional composition. (rsc.org)
And Gold Millet has advanced biological fermentation producing equipment, first-class testing method, modernized scientific management and high quality employees. (indiabizclub.com)

The National Institute of Biological Sciences (NIBS), Beijing, recently became the owners of the 100th Opera® High Content Screening System to be installed across the globe. (perkinelmer.com)
Thank you for your interest in spreading the word on Proceedings of the Royal Society of London B: Biological Sciences. (royalsocietypublishing.org)
Message Body (Your Name) thought you would like to see the Proceedings of the Royal Society of London B: Biological Sciences web site. (royalsocietypublishing.org)

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)

The entries in the exhibitor & product database correspond to the registration status for POWTECH 2019. (powtech.de)

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)
The emergence of biological drugs has led to an increase in lyophilised drug products in the market. (europeanpharmaceuticalreview.com)
The Central Drugs Standard Control Organization (CDSCO), India's Authority for Medicinal Product, has published a draft Guideline on Good Distribution Practice (GDP) for biological products. (gmp-compliance.org)

These products rely, in part, for their licensing on prior information regarding safety and efficacy obtained with the originator products. (who.int)
The intention of this document is to provide globally acceptable principles for licensing biotherapeutic products that are claimed to be similar to biotherapeutic products of assured quality, safety, and efficacy that have been licensed based on a full licensing dossier. (who.int)

Natural products and their derivatives continue to be wellsprings of nascent therapeutic potential. (ucsd.edu)

The Commission reviewed the context and provisions of the Biotech Directive and published a notice on 3 November 2016 ( Notice 2016/C 411/03 ) concluding that the European Union legislators' intention when adopting the Biotech Directive was to exclude such products from patentability. (blogspot.com)
In the May 4, 2016, Federal Register , FDA issued both a proposed and direct final rule amending the general biological products standards relating to dating periods and removing certain standards relating to standard preparations and limits of potency. (mondaq.com)

What Center has the regulatory responsibility for therapeutic biological products? (fda.gov)
As previously noted, some therapeutic protein products are approved under section 505 of the FDC Act, not under the PHS Act. (fda.gov)
The demonstration of bioequivalence of the generic medicine with a reference product is usually appropriate and sufficient to infer therapeutic equivalence between the generic medicine and the reference product. (who.int)
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)

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)

Any officer, agent, or employee of the Department of Health and Human Services, authorized by the Secretary for the purpose, may during all reasonable hours enter and inspect any establishment for the propagation or manufacture and preparation of any biological product. (house.gov)
The development and manufacture of biopharma products is set to be one of the fastest growing sections of the industry. (nsf.org)
It also discusses the use of the activity unit to define a quality attribute during product manufacture and control. (europa.eu)

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)

Group schemes and commercial applications use the AT-75 to AT-400 biological reactors. (environmental-expert.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)
[5] 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)

The proprietary name and the established name of the drug, if any, as defined in section 502(e)(3) of the Federal Food, Drug, and Cosmetic Act (the act) or, for biological products, the proper name (as defined in § 600.3 of this chapter) including any appropriate descriptors. (cornell.edu)

Biological Insecticide, 32 Oz Concentrate, Omri from Sears. (westfield.com)

Review the statutory definitions of a biological product as well as distinctions that drive jurisdiction and regulatory pathway. (fdli.org)

We recently initiated a Phase 1/2a study of this promising product in solid tumors, as both monotherapy and in combination with checkpoint inhibitors, and we anticipate initial top-line results from this important study by the end of 2020. (pharmiweb.com)

Diver Reconnaissance System products from Divex Accurate Information To Divers And CommandersDiver Reconnaissance System The Diver Reconnaissance System enables the diver to undertake both underwater navigation and search tasks providing accurate information to divers and commanders. (subsea.org)
Search by Keyword, Part #, Product or Accessory Type. (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)
Browse or search the topics or products of interest. (biotek.com)
Our webinar archives are available for on-demand viewing - search to find a topic, application or product of interest. (biotek.com)
Search the more than 3,000 scientific citations for BioTek's products within our database to learn more about the applications for our life science instrumentation as they're used around the world. (biotek.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)

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)
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)

A brief overview of the phases of the regulatory development pathway for HCT/Ps regulated as biological products is shown below. (aabb.org)

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)

The biopharmaceuticals products segment accounted for the largest share of the global biological product manufacturing market. (sbwire.com)

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 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)

When combined with Stormdry Masonry Protection Cream , Safeguard's biocidal solution can protect walls from both damp and biological growth. (buildingtalk.com)
Safeguard's SoluGuard Multi-Surface Biocide is a biocidal solution, which has been designed to remove biological growth and tackle moss and algae. (buildingtalk.com)
Once the combined system has been applied, the wall will be protected from both damp and biological growth. (buildingtalk.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)
Coping with Biological Grown on Stone Heritage Objects provides many case studies of removal of biological growth with practical advice for making the right choices. (nhbs.com)
Results on new substances with antimicrobic properties and alternative methods for the control of biological growth are presented as well. (nhbs.com)

The EPO announced on 12 December that it has stayed all examination and opposition proceedings relating to plants and animals obtained by an essentially biological process. (blogspot.com)
2) Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process. (blogspot.com)
From bacteria to plants, biological agents pose serious risks to the preservation of cultural heritage. (nhbs.com)

This ELISA kit can be used for measuring intact proinsulin, not including cleaved intermediate products, in mouse and rat samples. (ibl-japan.co.jp)

FDA also says it saw an uptick in the number of reports related to CBER-licensed IVDs, mostly related to unexpected reactions in testing, leaking vials or containers and products being received upside-down or on their side inside their shipping container. (raps.org)

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)
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)

This organic product is OMRI listed, and is safe for people and pets when used as directed. (westfield.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)
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 biological half-life of caesium in humans is between one and four months. (wikipedia.org)

For some substances, it is important to think of the human or animal body as being made up of several parts, each with their own affinity for the substance, and each part with a different biological half-life (physiologically-based pharmacokinetic modelling). (wikipedia.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)
In recent years, marine natural products have gained attention from scientists within diverse research fields, such as biology, pharmacology, medicine and chemistry. (uio.no)
In future research, the discussed principle-based approaches can be more actively applied to determine and predict not only the abatement levels of the parent micropollutants but also the formation of transformation products and the consequent changes of biological activities and biodegradability, which determines the overall treatment efficiency. (rsc.org)
Major market players in the global biological product manufacturing market have various advantages such as cutting edge technologies, superior research and development, technologically advanced instruments, and skilled workforce to ensure proper assembly and delivery of the product. (sbwire.com)
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)
The hospitals end-user segment accounted for the largest share of the global biological product manufacturing market, followed by research and academic institutes. (sbwire.com)
North America dominated the global biological product manufacturing market in 2015 due to factors such as new and technologically advanced products introduced in the market, significant investments in research and development of advanced products, and increasing patient demand for better health care facilities. (sbwire.com)
Journal of Stored Products and Postharvest Research, 1(2), 18 -23. (academicjournals.org)
Please note that our products are for research use only and cannot be delivered to private persons and addresses, but only to authorized institutions and businesses. (biomol.com)
The research will also study the biological stability of this community over the long-term and how it responds to environmental fluctuations. (kwrwater.nl)

Treatments comprising two pathogenic fungi, each paired with three biological antagonists were set up. (academicjournals.org)

Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1). (cornell.edu)
Processing kiwifruit into juice, wine and vinegar retained a higher vitamin C and polyphenol content than dried slices and jam and demonstrated better biological activities, while dried slices and jam provided more mineral elements than the three liquid products. (rsc.org)
BioTek's application notes present the latest-breaking scientific content covering the vast range of applications across our entire product line. (biotek.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)

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)
Are the biologic development requirements different than the requirements for a new drug product? (fda.gov)
3) The Secretary shall prescribe requirements under which a biological product undergoing investigation shall be exempt from the requirements of paragraph (1). (house.gov)
Viking Drysuit products from Divex Designed And Custom-Made For MissionViking Drysuit Designed and custom-made for mission specific requirements Viking's military grade equipment is crafted for maximum performance, user-compatibility and damage resistance. (subsea.org)
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)

The efficiency of ozonation for micropollutant abatement depends on (1) the reactivity of ozone and OH radical (˙OH) with the target micropollutant, (2) the dosage of ozone and the stability of ozone and ˙OH in a given water matrix, (3) the removal of undesirable effects ( e.g. , biological activities) of a micropollutant after structural transformation, and (4) the biodegradability of transformation products in biological post-treatment. (rsc.org)

Following the Broccoli and Tomato cases (G2/12 Tomatoes II and G3/12 Broccoli II, discussed on the IPKat here ), the Enlarged Board of the EPO ruled that even where an essentially biological process for the production of a plant or animal is not patentable, the resultant animal or plant may itself be patentable. (blogspot.com)

Abrilada (Adalimumab-afzb Injection, for Subcutaneous Use): Uses, Dosage, Side Effects, Interactions, Warning (rxlist.com)

Biological Product | Definition of Biological Product by Merriam-Webster (merriam-webster.com)

Aristotle's Revenge: The Metaphysical Foundations of Physical and Biological Science / Edition 1 by Edward Feser |... (barnesandnoble.com)

Monkeys edge ecology and management long tailed macaques and their interface humans | Biological anthropology and primatology |... (cambridge.org)

Lifegard Aquatics TRIO Kit 1022 GPH Pond Filter with Quiet Pump with Mechanical and Biological Filtration R440023 - The Home... (homedepot.com)

Development Studies: Environment & the Developing World - Routledge (routledge.com)

The Growth of Biological Thought - Ernst Mayr | Harvard University Press (hup.harvard.edu)

Arteries and Arterial Blood Flow: Biological and Physiological Aspects: C. M. Rodkiewicz: : 9780387816357: Powell's Books (powells.com)

Cerebral Dominance - Norman Geschwind, Albert M. Galaburda | Harvard University Press (hup.harvard.edu)

First in Fly - Stephanie Elizabeth Mohr | Harvard University Press (hup.harvard.edu)

Regulatory Strategy and Submissions - NSF International (nsf.org)

Microbiology | Book | English | Springer (springer.com)

Ariel Actilift Powder Biological 1.43Kg 22 Wash - Tesco Groceries (tesco.com)

Persil Powercaps Biological Washing Capsules 38 Wash 1.026Kg - Tesco Groceries (tesco.com)

Analysis of Free Radicals in Biological Systems | SpringerLink (link.springer.com)

Whitefly Control with Encarsia -natural biological product | cornishcabbageplants (cornishcabbageplants.com)

Fertility Farming
- Acres USA — Fertility Farming - Acres USA (acresusa.com)

Talking Chicken by Kelly Klober
- Acres USA — Talking Chicken by Kelly Klober - Acres USA (acresusa.com)

Chemistry Archives - Page 10 of 43 - Nova Science Publishers (novapublishers.com)

2-(DIETHYLAMINO)-ETHYL ACRYLATE By Hebei Supai Biological Technology Co., Ltd., China (tradekey.com)

Sources of High Biological Protein (ehow.co.uk)

Carolina® Antibiotic Production Kit (with Prepaid Coupon) | Carolina.com (carolina.com)

Biological functions and activities of animal carotenoids (degruyter.com)

Hygromycin B from Streptomyces hygroscopicus suitable for plant cell culture, BioReagent, ≥60% (HPLC), lyophilized powder |... (sigmaaldrich.com)

GC-MS analysis and biological activities of Thymus vulgaris and Mentha arvensis essential oil (degruyter.com)

A biological profile for diagnosis and outcome of COVID-19 patients (degruyter.com)

Organisms4

Diseases2

Chemicals and Drugs11

Analytical, Diagnostic and Therapeutic Techniques and Equipment8

Phenomena and Processes2

Disciplines and Occupations2

Anthropology, Education, Sociology and Social Phenomena5

Technology, Industry, Agriculture6

Information Science7

Named Groups1

Health Care13

Geographicals1

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

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

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

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)

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

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

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

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

Biological Products

Legislation, Drug

Pharmaceutic Aids

United States Food and Drug Administration

Investigational New Drug Application

Pestivirus Infections

Drug Contamination

Preservation, Biological

Drug Approval

Drug Labeling

Consumer Product Safety

Preservatives, Pharmaceutical

Drugs, Investigational

Drug Industry

Safety

Quality Control

Pharmaceutical Preparations

Guidelines as Topic

Chemistry, Pharmaceutical

United States

Models, Biological

Molecular Sequence Data

Amino Acid Sequence

Base Sequence

Biological Assay

Biological Therapy

Biotechnology

N-Ethylmaleimide-Sensitive Proteins

Cyclic GMP

Medical Audit

Water

Libraries, Medical

Pest Control

Pest Control, Biological

Insect Control

Organic Agriculture

Agrochemicals

Bedbugs

Insecticides

Patents as Topic

Computers

Software

Inventions

Autoanalysis

Intellectual Property

Computer Simulation

Oenothera

Medical Secretaries

Methoprene

Cestode Infections

Cestoda

Viola

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

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

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

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)

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

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

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

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

China Red Yeast Rice Extract / Red Yeast Rice / Red Rice Yeast - China Red Yeast Rice Extract, Red Yeast Rice Powder

Natural products - Drug discovery and therapeutic medicine - Zh Torrent Download - LimeTorrents

Solaray - Red Yeast Rice 600 mg 120 Capsules - Save 45%

Natural Product-Derived Spirooxindole Fragments Serve as Privileged Substructures for Discovery of New Anticancer Agents |...

Merck Donates Natural Products Library For Research - Intellectual Property Watch

Rapid Screening of a Cell-based Assay for GLP-1 Receptor Using a Natural Product Library | August 7, 2012

Natural Product Chemistry for Drug Discovery: RSC (RSC Biomolecular Sciences) direct download | bukmekerskajakontora.ru

Red Yeast Rice Supplements for High Cholesterol | Prevention

Colon Cancer and Red Yeast Rice - Article Preview

Red Yeast Rice Extract - Red Yeast Rice Extract Suppliers, Buyers, Wholesalers and Manufacturers - ecplaza.net

Red Yeast Rice Extract | Article about Red Yeast Rice Extract by The Free Dictionary

Expert discusses natural products chemistry and anticancer drug discovery | WMU News | Western Michigan University

Bioactive Microbial Natural Products from Unique Indonesian Black Water Ecosystems

The Study Botanical: Coenzyme Q-10 and Red Yeast Rice

Harnessing the Chemistry of Plant Natural Product Biosynthesis | Duke Chemistry

Red Yeast Rice With Co Q 10 - List Owel Food Fair

Kal Red Yeast Rice - KAL - Red Yeast Rice Once Daily 1200mg - 30ct Tab

Buy Protocol for Life Balance Red Yeast Rice Extract - 600 mg - 90 VCapsules - eVitamins Australia

KAL - Red Yeast Rice, CoQ10, Omega 3 600/30/500mg - 60ct Sg

NOW Red Yeast Rice - Customer Reviews at Netrition.com