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.
Consumer Product Safety refers to the measures and regulations implemented to ensure household items, toys, and other consumer products are designed, manufactured, and distributed in a manner that minimizes risks of harm, injury, or death to consumers during normal use or foreseeable misuse.
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.
The term "United States" in a medical context often refers to the country where a patient or study participant resides, and is not a medical term per se, but relevant for epidemiological studies, healthcare policies, and understanding differences in disease prevalence, treatment patterns, and health outcomes across various geographic locations.
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.

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)

According to the United States Food and Drug Administration (FDA), biological products are "products that are made from or contain a living organism or its derivatives, such as vaccines, blood and blood components, cells, genes, tissues, and proteins." These products can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, and they can come from many sources, including humans, animals, microorganisms, or plants.

Biological products are often used to diagnose, prevent, or treat a wide range of medical conditions, and they can be administered in various ways, such as through injection, inhalation, or topical application. Because biological products are derived from living organisms, their manufacturing processes can be complex and must be tightly controlled to ensure the safety, purity, and potency of the final product.

It's important to note that biological products are not the same as drugs, which are chemically synthesized compounds. While drugs are designed to interact with specific targets in the body, such as enzymes or receptors, biological products can have more complex and varied mechanisms of action, making them potentially more difficult to characterize and regulate.

'Drug legislation' refers to the laws and regulations that govern the production, distribution, sale, possession, and use of medications and pharmaceutical products within a given jurisdiction. These laws are designed to protect public health and safety by establishing standards for drug quality, ensuring appropriate prescribing and dispensing practices, preventing drug abuse and diversion, and promoting access to necessary medications. Drug legislation may also include provisions related to clinical trials, advertising, packaging, labeling, and reimbursement. Compliance with these regulations is typically enforced through a combination of government agencies, professional organizations, and legal penalties for non-compliance.

Pharmaceutic aids, also known as pharmaceutical excipients or additives, are substances that are added to pharmaceutical formulations during the manufacturing process. They are not intended to have any therapeutic effect, but rather to improve the drug's stability, bioavailability, palatability, or patient compliance.

Examples of pharmaceutic aids include binders, fillers, coatings, disintegrants, preservatives, coloring agents, and flavoring agents. Binders help hold the active ingredients together in a solid form, while fillers are used to add bulk to the formulation. Coatings can be used to protect the drug from degradation or to make it easier to swallow. Disintegrants help the tablet or capsule break down quickly in the digestive tract so that the active ingredient can be absorbed more efficiently. Preservatives are added to prevent microbial growth, while coloring and flavoring agents improve the appearance and taste of the medication.

It is important to note that pharmaceutic aids must undergo rigorous testing to ensure their safety and compatibility with the active ingredients in the drug formulation. Some people may have allergies or sensitivities to certain excipients, so it is essential to consider these factors when developing and prescribing medications.

The United States Food and Drug Administration (FDA) is a federal government agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our country's food supply, cosmetics, and products that emit radiation. The FDA also provides guidance on the proper use of these products, and enforces laws and regulations related to them. It is part of the Department of Health and Human Services (HHS).

An Investigational New Drug Application (IND) is a regulatory submission required by the United States Food and Drug Administration (FDA) for a sponsor to start clinical trials with a new drug. The IND application includes data from previous non-clinical studies, the plan for clinical studies, manufacturing information, investigator information, and the investigational drug's chemistry, pharmacology, and toxicology. The FDA reviews the IND to ensure that the proposed study does not pose unreasonable safety risks to human subjects and that the study design is scientifically sound. Once the IND is approved, the clinical trial can begin.

Pestivirus infections refer to a group of diseases caused by viruses of the genus Pestivirus, which belongs to the family Flaviviridae. There are several different types of Pestiviruses, including bovine viral diarrhea virus 1 and 2 (BVDV-1 and BVDV-2), classical swine fever virus (CSFV), and border disease virus (BDV).

These viruses can cause a range of clinical signs in animals, depending on the species infected, the age and immune status of the animal, and the strain of the virus. In general, Pestivirus infections can cause fever, lethargy, loss of appetite, and various symptoms related to the respiratory, digestive, or reproductive systems.

For example, BVDV-1 and BVDV-2 are important pathogens in cattle and can cause a variety of clinical signs, including respiratory disease, diarrhea, reproductive failure, and immunosuppression. CSFV is a highly contagious virus that affects pigs and can cause fever, loss of appetite, hemorrhages, and neurological symptoms. BDV infects sheep and goats and can cause abortion, stillbirth, and congenital defects in offspring.

Prevention and control measures for Pestivirus infections include vaccination, biosecurity practices, and testing and culling of infected animals.

Drug contamination refers to the presence of impurities or foreign substances in a pharmaceutical drug or medication. These impurities can include things like bacteria, chemicals, or other drugs that are not intended to be present in the final product. Drug contamination can occur at any stage during the production, storage, or distribution of a medication and can potentially lead to reduced effectiveness, increased side effects, or serious health risks for patients. It is closely monitored and regulated by various health authorities to ensure the safety and efficacy of medications.

Biological preservation is the process of preventing decomposition or decay of biological materials, such as tissues, cells, organs, or organisms, in order to maintain their structural and functional integrity for further studies, research, education, or conservation purposes. This can be achieved through various methods, including fixation, freezing, drying, or the use of chemical preservatives. The goal is to maintain the samples in a stable state so that they can be examined, analyzed, or used in experiments at a later time.

"Drug approval" is the process by which a regulatory agency, such as the US Food and Drug Administration (FDA), grants formal authorization for a pharmaceutical company to market and sell a drug for a specific medical condition. The approval process is based on rigorous evaluation of clinical trial data to ensure that the drug is safe and effective for its intended use.

The FDA's approval process typically involves several stages, including preclinical testing in the lab and animal studies, followed by three phases of clinical trials in human subjects. The first phase tests the safety of the drug in a small group of healthy volunteers, while the second and third phases test the drug's efficacy and side effects in larger groups of patients with the medical condition for which the drug is intended.

If the results of these studies demonstrate that the drug is safe and effective, the pharmaceutical company can submit a New Drug Application (NDA) or Biologics License Application (BLA) to the FDA for review. The application includes data from the clinical trials, as well as information about the manufacturing process, labeling, and proposed use of the drug.

The FDA reviews the application and may seek input from independent experts before making a decision on whether to approve the drug. If approved, the drug can be marketed and sold to patients with the medical condition for which it was approved. The FDA continues to monitor the safety and efficacy of approved drugs after they reach the market to ensure that they remain safe and effective for their intended use.

Drug labeling refers to the information that is provided on the packaging or container of a medication, as well as any accompanying promotional materials. This information is intended to provide healthcare professionals and patients with accurate and up-to-date data about the drug's composition, intended use, dosage, side effects, contraindications, and other important details that are necessary for safe and effective use.

The labeling of prescription drugs in the United States is regulated by the Food and Drug Administration (FDA), which requires manufacturers to submit proposed labeling as part of their new drug application. The FDA reviews the labeling to ensure that it is truthful, balanced, and not misleading, and provides accurate information about the drug's risks and benefits.

The labeling of over-the-counter (OTC) drugs is also regulated by the FDA, but in this case, the agency has established a set of monographs that specify the conditions under which certain active ingredients can be used and the labeling requirements for each ingredient. Manufacturers of OTC drugs must ensure that their labeling complies with these monographs.

In addition to the information required by regulatory agencies, drug labeling may also include additional information provided by the manufacturer, such as detailed instructions for use, storage requirements, and any warnings or precautions that are necessary to ensure safe and effective use of the medication. It is important for healthcare professionals and patients to carefully review and understand all of the information provided on a drug's labeling before using the medication.

Consumer Product Safety refers to the measures taken to ensure that products intended for consumer use are free from unreasonable risks of injury or illness. This is typically overseen by regulatory bodies, such as the Consumer Product Safety Commission (CPSC) in the United States, which establishes safety standards, tests products, and recalls dangerous ones.

The definition of 'Consumer Product' can vary but generally refers to any article, or component part thereof, produced or distributed (i) for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation, or otherwise; (ii) for the personal use, consumption or enjoyment of a consumer in or around a permanent or temporary household or residence, a school, in recreation, or otherwise; (iii) for sensory evaluation and direct physical contact by a consumer in or around a permanent or temporary household or residence, a school, in recreation, or otherwise.

The safety measures can include various aspects such as design, manufacturing, packaging, and labeling of the product to ensure that it is safe for its intended use. This includes ensuring that the product does not contain any harmful substances, that it functions as intended, and that it comes with clear instructions for use and any necessary warnings.

It's important to note that even with these safety measures in place, it is still possible for products to cause injury or illness if they are used improperly or if they malfunction. Therefore, it is also important for consumers to be aware of the risks associated with the products they use and to take appropriate precautions.

Pharmaceutical preservatives are substances that are added to medications, pharmaceutical products, or biological specimens to prevent degradation, contamination, or spoilage caused by microbial growth, chemical reactions, or environmental factors. These preservatives help extend the shelf life and ensure the stability, safety, and efficacy of the pharmaceutical formulation during storage and use.

Commonly used pharmaceutical preservatives include:

1. Antimicrobials: These are further classified into antifungals (e.g., benzalkonium chloride, chlorhexidine, thimerosal), antibacterials (e.g., parabens, phenol, benzyl alcohol), and antivirals (e.g., phenolic compounds). They work by inhibiting the growth of microorganisms like bacteria, fungi, and viruses.
2. Antioxidants: These substances prevent or slow down oxidation reactions that can degrade pharmaceutical products. Examples include ascorbic acid (vitamin C), tocopherols (vitamin E), sulfites, and butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT).
3. Chelating agents: These bind to metal ions that can catalyze degradation reactions in pharmaceutical products. Ethylenediaminetetraacetic acid (EDTA) is an example of a chelating agent used in pharmaceuticals.

The choice of preservative depends on the type of formulation, route of administration, and desired shelf life. The concentration of the preservative should be optimized to maintain product stability while minimizing potential toxicity or adverse effects. It is essential to conduct thorough safety and compatibility studies before incorporating any preservative into a pharmaceutical formulation.

Investigational drugs, also known as experimental or trial drugs, refer to medications that are currently being tested in clinical trials to evaluate their safety and efficacy for the treatment of various medical conditions. These drugs have not yet been approved by regulatory agencies such as the US Food and Drug Administration (FDA) for general use.

Before entering clinical trials, investigational drugs must undergo extensive preclinical testing in the lab and on animals to assess their safety and potential therapeutic benefits. Clinical trials are conducted in phases, starting with small groups of healthy volunteers to assess safety, followed by larger groups of patients to evaluate efficacy and side effects.

Participation in clinical trials is voluntary, and participants must meet certain eligibility criteria to ensure their safety and the validity of the trial results. Investigational drugs may ultimately be approved for general use if they are found to be safe and effective in clinical trials.

The "drug industry" is also commonly referred to as the "pharmaceutical industry." It is a segment of the healthcare sector that involves the research, development, production, and marketing of medications or drugs. This includes both prescription and over-the-counter medicines used to treat, cure, or prevent diseases and medical conditions in humans and animals.

The drug industry comprises various types of organizations, such as:

1. Research-based pharmaceutical companies: These are large corporations that focus on the research and development (R&D) of new drugs, clinical trials, obtaining regulatory approvals, manufacturing, and marketing their products globally. Examples include Pfizer, Johnson & Johnson, Roche, and Merck.

2. Generic drug manufacturers: After the patent for a brand-name drug expires, generic drug manufacturers can produce and sell a similar version of the drug at a lower cost. These companies must demonstrate that their product is bioequivalent to the brand-name drug in terms of safety, quality, and efficacy.

3. Biotechnology companies: These firms specialize in developing drugs using biotechnological methods, such as recombinant DNA technology, gene therapy, or monoclonal antibodies. Many biotech companies focus on specific therapeutic areas, like oncology, immunology, or neurology.

4. Contract research organizations (CROs): CROs provide various services to the drug industry, including clinical trial management, data analysis, regulatory affairs support, and pharmacovigilance. They work with both large pharmaceutical companies and smaller biotech firms to help streamline the drug development process.

5. Drug delivery system companies: These organizations focus on developing innovative technologies for delivering drugs more effectively and safely to patients. Examples include transdermal patches, inhalers, or long-acting injectables.

6. Wholesalers and distributors: Companies that purchase drugs from manufacturers and distribute them to pharmacies, hospitals, and other healthcare providers.

The drug industry plays a crucial role in improving public health by discovering, developing, and delivering new treatments for various diseases and medical conditions. However, it is also subject to criticism and regulation due to concerns about high drug prices, marketing practices, and the potential for conflicts of interest between industry and healthcare professionals.

In the context of healthcare, "safety" refers to the freedom from harm or injury that is intentionally designed into a process, system, or environment. It involves the prevention of adverse events or injuries, as well as the reduction of risk and the mitigation of harm when accidents do occur. Safety in healthcare aims to protect patients, healthcare workers, and other stakeholders from potential harm associated with medical care, treatments, or procedures. This is achieved through evidence-based practices, guidelines, protocols, training, and continuous quality improvement efforts.

"Quality control" is a term that is used in many industries, including healthcare and medicine, to describe the systematic process of ensuring that products or services meet certain standards and regulations. In the context of healthcare, quality control often refers to the measures taken to ensure that the care provided to patients is safe, effective, and consistent. This can include processes such as:

1. Implementing standardized protocols and guidelines for care
2. Training and educating staff to follow these protocols
3. Regularly monitoring and evaluating the outcomes of care
4. Making improvements to processes and systems based on data and feedback
5. Ensuring that equipment and supplies are maintained and functioning properly
6. Implementing systems for reporting and addressing safety concerns or errors.

The goal of quality control in healthcare is to provide high-quality, patient-centered care that meets the needs and expectations of patients, while also protecting their safety and well-being.

Pharmaceutical preparations refer to the various forms of medicines that are produced by pharmaceutical companies, which are intended for therapeutic or prophylactic use. These preparations consist of an active ingredient (the drug) combined with excipients (inactive ingredients) in a specific formulation and dosage form.

The active ingredient is the substance that has a therapeutic effect on the body, while the excipients are added to improve the stability, palatability, bioavailability, or administration of the drug. Examples of pharmaceutical preparations include tablets, capsules, solutions, suspensions, emulsions, ointments, creams, and injections.

The production of pharmaceutical preparations involves a series of steps that ensure the quality, safety, and efficacy of the final product. These steps include the selection and testing of raw materials, formulation development, manufacturing, packaging, labeling, and storage. Each step is governed by strict regulations and guidelines to ensure that the final product meets the required standards for use in medical practice.

'Guidelines' in the medical context are systematically developed statements or sets of recommendations designed to assist healthcare professionals and patients in making informed decisions about appropriate health care for specific clinical circumstances. They are based on a thorough evaluation of the available evidence, including scientific studies, expert opinions, and patient values. Guidelines may cover a wide range of topics, such as diagnosis, treatment, prevention, screening, and management of various diseases and conditions. They aim to standardize care, improve patient outcomes, reduce unnecessary variations in practice, and promote efficient use of healthcare resources.

Pharmaceutical chemistry is a branch of chemistry that deals with the design, synthesis, and development of chemical entities used as medications. It involves the study of drugs' physical, chemical, and biological properties, as well as their interactions with living organisms. This field also encompasses understanding the absorption, distribution, metabolism, and excretion (ADME) of drugs in the body, which are critical factors in drug design and development. Pharmaceutical chemists often work closely with biologists, medical professionals, and engineers to develop new medications and improve existing ones.

I'm sorry for any confusion, but "United States" is a geopolitical entity, specifically the name of the country consisting of 50 states, and it is not a medical term or concept. Therefore, I can't provide a medical definition for it. If you have any questions related to health, medicine, or biology, I would be happy to try to help answer those!

Biological models, also known as physiological models or organismal models, are simplified representations of biological systems, processes, or mechanisms that are used to understand and explain the underlying principles and relationships. These models can be theoretical (conceptual or mathematical) or physical (such as anatomical models, cell cultures, or animal models). They are widely used in biomedical research to study various phenomena, including disease pathophysiology, drug action, and therapeutic interventions.

Examples of biological models include:

1. Mathematical models: These use mathematical equations and formulas to describe complex biological systems or processes, such as population dynamics, metabolic pathways, or gene regulation networks. They can help predict the behavior of these systems under different conditions and test hypotheses about their underlying mechanisms.
2. Cell cultures: These are collections of cells grown in a controlled environment, typically in a laboratory dish or flask. They can be used to study cellular processes, such as signal transduction, gene expression, or metabolism, and to test the effects of drugs or other treatments on these processes.
3. Animal models: These are living organisms, usually vertebrates like mice, rats, or non-human primates, that are used to study various aspects of human biology and disease. They can provide valuable insights into the pathophysiology of diseases, the mechanisms of drug action, and the safety and efficacy of new therapies.
4. Anatomical models: These are physical representations of biological structures or systems, such as plastic models of organs or tissues, that can be used for educational purposes or to plan surgical procedures. They can also serve as a basis for developing more sophisticated models, such as computer simulations or 3D-printed replicas.

Overall, biological models play a crucial role in advancing our understanding of biology and medicine, helping to identify new targets for therapeutic intervention, develop novel drugs and treatments, and improve human health.

Molecular sequence data refers to the specific arrangement of molecules, most commonly nucleotides in DNA or RNA, or amino acids in proteins, that make up a biological macromolecule. This data is generated through laboratory techniques such as sequencing, and provides information about the exact order of the constituent molecules. This data is crucial in various fields of biology, including genetics, evolution, and molecular biology, allowing for comparisons between different organisms, identification of genetic variations, and studies of gene function and regulation.

An amino acid sequence is the specific order of amino acids in a protein or peptide molecule, formed by the linking of the amino group (-NH2) of one amino acid to the carboxyl group (-COOH) of another amino acid through a peptide bond. The sequence is determined by the genetic code and is unique to each type of protein or peptide. It plays a crucial role in determining the three-dimensional structure and function of proteins.

A base sequence in the context of molecular biology refers to the specific order of nucleotides in a DNA or RNA molecule. In DNA, these nucleotides are adenine (A), guanine (G), cytosine (C), and thymine (T). In RNA, uracil (U) takes the place of thymine. The base sequence contains genetic information that is transcribed into RNA and ultimately translated into proteins. It is the exact order of these bases that determines the genetic code and thus the function of the DNA or RNA molecule.

A biological assay is a method used in biology and biochemistry to measure the concentration or potency of a substance (like a drug, hormone, or enzyme) by observing its effect on living cells or tissues. This type of assay can be performed using various techniques such as:

1. Cell-based assays: These involve measuring changes in cell behavior, growth, or viability after exposure to the substance being tested. Examples include proliferation assays, apoptosis assays, and cytotoxicity assays.
2. Protein-based assays: These focus on measuring the interaction between the substance and specific proteins, such as enzymes or receptors. Examples include enzyme-linked immunosorbent assays (ELISAs), radioimmunoassays (RIAs), and pull-down assays.
3. Genetic-based assays: These involve analyzing the effects of the substance on gene expression, DNA structure, or protein synthesis. Examples include quantitative polymerase chain reaction (qPCR) assays, reporter gene assays, and northern blotting.

Biological assays are essential tools in research, drug development, and diagnostic applications to understand biological processes and evaluate the potential therapeutic efficacy or toxicity of various substances.

Biological therapy, also known as biotherapy or immunotherapy, is a type of medical treatment that uses biological agents (such as substances derived from living organisms or laboratory-made versions of these substances) to identify and modify specific targets in the body to treat diseases, including cancer. These therapies can work by boosting the body's natural defenses to fight illness, interfering with the growth and spread of abnormal cells, or replacing absent or faulty proteins in the body. Examples of biological therapies include monoclonal antibodies, cytokines, and vaccines.

"Shenzhen Kangtai Biological Products Co Ltd". Bloomberg. Retrieved 1 August 2021. "Kangtai Biological's COVID-19 vaccine gets ... 22°32′48″N 113°56′37″E / 22.5467°N 113.9437°E / 22.5467; 113.9437 Shenzhen Kangtai Biological Products (Chinese: 深圳康泰生物制品股份有 ... manufactures and markets vaccines and other vaccine products. Kangtai develops the Minhai COVID-19 vaccine and has the ...
The Wuhan Institute of Biological Products (WIBP Chinese: 武汉生物制品研究所) or Wuhan Institute of Biology for short is a subsidiary of ... Philippidis, Alex (May 18, 2020). "Sinopharm Group (Wuhan Institute of Biological Products) and Chinese Academy of Sciences ( ... and operates one of the main production facilities for biological products in China, with over 1,000 employees. The commercial ... which is primarily focused on the production distribution of blood products including human albumin, human immune globulin and ...
Full Prescribing Information" (PDF). Janssen Products, Dec 2012. Retrieved 24 February 2020. Nikolas C Papanikolaou; Eleftheria ... Polonium in the body has a biological half-life of about 30 to 50 days. Caesium in the body has a biological half-life of about ... Lead in bone has a biological half-life of about ten years. Cadmium in bone has a biological half-life of about 30 years. ... Biological half-life (elimination half-life, pharmacological half-life) is the time taken for concentration of a biological ...
Biosimilars are defined by the FDA as, "a biological product that is highly similar to and has no clinically meaningful ... which often does not include traditional biological substances like vaccines. Today, biological therapy most commonly refers to ... Biological therapy has found a niche in the management of cancer, autoimmune diseases, and diseases of unknown cause that ... The advancements in biological therapy greatly changed how IBD is treated. Patients with Crohn's disease and ulcerative colitis ...
Drug discovery Environmental impact of pharmaceuticals and personal care products Raffa RB, Porreca F (1989). "Thermodynamic ... A biological target is anything within a living organism to which some other entity (like an endogenous ligand or a drug) is ... Biological targets are most commonly proteins such as enzymes, ion channels, and receptors. The external stimulus (i.e., the ... The term "biological target" is frequently used in pharmaceutical research to describe the native protein in the body whose ...
Bandaranayake WM (April 2006). "The nature and role of pigments of marine invertebrates". Natural Product Reports. 23 (2): 223- ... Biological pigments include plant pigments and flower pigments. Many biological structures, such as skin, eyes, feathers, fur ... However, some biological pigments in animals, such as heme groups that help to carry oxygen in the blood, are colored as a ... Biological pigments, also known simply as pigments or biochromes, are substances produced by living organisms that have a color ...
In addition, gene products rarely act alone. Instead, they perform their function by interacting together in pathways and ... but there are five main methods used to investigate the biological basis of personality. The biological data from these methods ... The biological basis of personality is the collection of brain systems and mechanisms that underlie human personality. Human ... From a biological perspective, these traits can be traced back to brain structures and neural mechanisms. However, this ...
Public understanding and responsible uses of biological engineering products. Through publications, meetings, distribution of ... The Institute of Biological Engineering or IBE is a non-profit professional organization which encourages inquiry and interest ... The IBE was established in 1995 to encourage inquiry and interest in biological engineering in the broadest and most liberal ... IBE promotes the view that biological engineering is a science-based, application-independent discipline that is aligned with ...
"AN-2203 Biological Indicator for EO (25/box)". Andersen Products. Archived from the original on 2013-10-06. Retrieved 2013-05- ... A study of the vulnerability of subway passengers in New York City to covert action with biological agents. Miscellaneous ... Yánez-Mendizábal V (2011). "Biological control of peach brown rot (Monilinia spp.) by Bacillus subtilis CPA-8 is based on ... 7-1. ISBN 978-0-86014-193-8. EFSA Panel on Biological Hazards (BIOHAZ) (2010). "Scientific opinion on the maintenance of the ...
Frozen or dried berries may be preferable for some baked berry products. Fresh berries are also often incorporated into baked ... Thiem B (2003). "Rubus chamaemorus L. - a boreal plant rich in biologically active metabolites: a review" (PDF). Biological ... Consequently, it is not permitted to claim that foods containing polyphenols have antioxidant health value on product labels in ... Yanyun Zhao (6 June 2007). Berry Fruit: Value-Added Products for Health Promotion. CRC Press. ISBN 978-1-4200-0614-8. Pritts, ...
Bee products, Dietary supplements, Beekeeping, Animal glandular products). ... Biological Reviews. 89 (2): 255-269. doi:10.1111/brv.12052. PMID 23855350. S2CID 29361726. Albert, Stefan; Bhattacharya, ... "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 ...
"Approved Products - ACAM2000". Retrieved 2018-09-08. "Biological Threats". Emergent BioSolutions. Retrieved 2018- ... Smallpox is considered a biological threat due to its potential to be used as a biological agent. Biological agents are toxins ... However, there has been interest in the development of vaccines due to the possible use of smallpox as a biological agent. ... enhances the emergency preparedness of the United States against the use of smallpox as a dangerous biological weapon." The ...
No biological tests confirm major depression. In general, investigations are not repeated for a subsequent episode unless there ... Duff G (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. ...
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: ... Journal of Biological Education. 56 (5): 1-8. doi:10.1080/00219266.2020.1858930. May P. "Chlorophyll". University of Bristol. " ...
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; ...
The company provides product development and cell culture services to the pharmaceutical and biological industries, including ... "Biological Industries named exclusive distributor of ATCC products in Israel". (Articles needing additional references from ... Biological Industries (BI) was founded in 1982 in the northern Kibbutz Beit Haemek, Israel. The company has expanded in the ... Biological Industries is an Israel multinational, chemicals and biotechnology company, headquartered in Israel, with R&D and ...
The products are primarily marketed as biological and biochemical fertilizer catalysts that increase nutrient availability, ... In July 2012, Agricen entered a strategic partnership with Loveland Products, Inc., a provider of crop input products and part ... Products are also available through Nutrien Ag Solutions locations in Canada, Australia and several countries in South America ... Agricen's products, which are manufactured in Denton, Texas and Victoria, Australia, are derived from natural microorganisms ...
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. Bibcode:2007PJAB...83..110I. doi:10.2183/pjab.83.110. PMC 3756735. ... 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 ...
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- ...
"Riverank Erosion Control Products". (CS1 errors: missing periodical, Articles with limited geographic scope from June 2021, ... Joint Biological Assessment. "River Maintenance Methods Attachment" (PDF). Retrieved 2013-11-24. Hansen, k (2000). Construction ... "Riverbank Erosion Control Products". Nasermoaddeli, M; Pasche. "Modelling of Undercutting and Failure of Non-cohesive ... Typically, willows and cottonwood poles are the most useful materials, however, fiber products may also be used are then ...
"Wonderberry". Center for New Crops & Plant Products, Purdue University. Taab, A (2009). Seed dormancy and germination in ... March 2000). "Anti-herpes virus activity of Solanum steroidal glycosides". Biological & Pharmaceutical Bulletin. 23 (3): 363-4 ... Nohara, T; Yahara, S.; Kinjo, J (1998). "Bioactive Glycosides from Solanaceous and Leguminous Plants". Natural Product Sciences ... a corn meal product). In the rest of Kenya, S. nigrum(managu) is eaten in a similar way. In Tanzania, S. nigrum (mnafu or ...
Linear systems contain no products between xs and are always solvable. They have the following form for all i: f i = a i 1 x 1 ... Biological applications of bifurcation theory provide a framework for understanding the behavior of biological networks modeled ... and bifurcations are therefore ubiquitous in biological networks such as the switches of the cell cycle. Biological networks ... Real biological systems are subject to small stochastic variations that introduce error terms into the dynamical equations, and ...
Carbon dioxide, a waste product, is released from the cells and into the blood, where it is converted to bicarbonate or binds ... During oxidative phosphorylation in cellular respiration, oxygen is reduced to water, thus closing the biological water-oxygen ... Reactive oxygen species (ROS) are by-products of cell aerobic respiration. Important examples include; oxygen free radicals ... which is an antibody-catalyzed product of singlet oxygen and water. This compound, in turn, disproportionates to ozone and ...
"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 ...
"Veterinary Biological Products" (PDF). USDA. April 1, 2020. Legendre, Al (2017). "Polyprenyl Immunostimulant in Feline ...
Dewick, Paul M (2009). Medicinal Natural Products: a biosynthetic approach (3rd ed.). Chichester U.K.: Wiley. p. 312. ISBN ... Journal of Biological Chemistry. 264 (20): 11744-11749. doi:10.1016/S0021-9258(18)80128-4. PMID 2745415. ...
"Biological Abstracts - Journal List". Intellectual Property & Science. Thomson Reuters. Archived from the original on 2016-01- ... "Journal of Natural Products". Library of Congress Catalog. Library of Congress. Retrieved 2016-01-19. Beall, Jeffrey. "Another ... "Journal of Natural Products". 2021 Journal Citation Reports. Web of Science (Science ed.). Clarivate. 2022. Official website ( ... The Journal of Natural Products is a monthly peer-reviewed scientific journal covering all aspects of research on the chemistry ...
Snell, Esmond E.; Guirard, Beverly M.; Williams, Roger J. (1942). "Occurrence in Natural Products of a Physiologically Active ... Metabolite of Pyridoxine". Journal of Biological Chemistry. 143 (2): 519-530. doi:10.1016/S0021-9258(18)72641-0. Snell, Esmond ...
... as well as spills of refined petroleum products (such as gasoline and diesel fuel) and their by-products, heavier fuels used by ... They are any biological species or group of species whose function, population, or status can reveal what degree of ecosystem ... Various chemical compounds found in personal hygiene and cosmetic products. Disinfection by-products found in chemically ... Biological testing involves the use of plant, animal or microbial indicators to monitor the health of an aquatic ecosystem. ...
Journal of Biological Chemistry. 290 (23): 14729-14739. doi:10.1074/jbc.M114.633065. ISSN 0021-9258. PMC 4505538. PMID 25911105 ... A Tax Gene Product (Tax) is a nuclear protein that has a molecular weight of about 37,000 to 40,000 daltons. Tax is produced by ... The Journal of Biological Chemistry. 279 (31): 31991-4. doi:10.1074/jbc.r400009200. PMID 15090550. Charoenthongtrakul, Soratree ...
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Center for Biological Diversity v. County of San Bernardino (Nursery Products, LLC). Final environmental impact report for ...
In commercially available latex products surveillance, water extracts prepared from one surgical glove and two silicone ... Relationship between pyrogenicity and bacterial endotoxin contamination on latex products was demonstrated by chemical analysis ... Chemical and biological evaluation of endotoxin contamination on natural rubber latex products J Biomed Mater Res. 2001 Jun 5; ... These biological properties, including pyrogenicity, completely disappeared by treating the pyrogenic extracts with endotoxin- ...
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CARM1 Inhibitor The CARM1 Inhibitor controls the biological activity of CARM1. This small molecule/inhibitor is primarily used ... by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a products label following the words Lot or ... Already Own This Product?. Documents related to the products that you have purchased in the past have been gathered in the ... Difficulty Finding Your Product Or Lot/Batch Number?. How to Find the Product Number ...
Biological response modifiers are increasingly used in viral and cancer therapy. Since alterations... ... Biological Response Modifiers Interferons, Double-Stranded RNA and 2,5 -Oligoadenylates by M. Ller, W. E. G. available in Trade ... Product Details. ISBN:. 9783642785511. Binding:. Trade Paperback. Publication date:. 12/08/2011. Publisher:. Springer. Series ... Biological Response Modifiers -- Interferons, Double-Stranded RNA and 2′,5′-Oligoadenylates by Muller, W. E. G. ...
Using Product Information. While every care has been taken to ensure product information is correct, food products are ... or the product manufacturer if not a Tesco brand product.. Although product information is regularly updated, Tesco is unable ... Product Description. Tesco Bio Colour Liquid Detergent Super Concentrated. Tesco Colour Bio Liquid Detergent Super Concentrated ... Warning,Causes serious eye irritation.,If medical advice is needed, have product container or label at hand.,Keep out of reach ...
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Taking into account that biological denitrification with the formation of N2 as the final product is observed only in a limited ... creating a prevailing competitive environment for nitrogen fixing bacteria from biological products. Under these circumstances ... Volkogon, V. V. (2013). Biological Nitrogen Transformation. The Direction of Processes at Different Levels of Crop Fertilizer. ... Product Quality Analysis. The starch content in tubers was determined using the Evers method (Ermakov, 1972), the ascorbic acid ...
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Vinnova invests another 12 million in three important centers for biological medicines. , Vinnova ... CAMP - Center for Advanced Medical Products. The first center in biological medicines in Sweden, which today is internationally ... The centers are part of an eight-year research program for biological medicines totaling SEK 320 million in the years 2016-2023 ... Thanks to these three centers, Sweden has established a good foundation for taking a leading position in biological medicines ...
Find product specifications and resources for Celerity HP Biological Indicators from STERIS or request a quote. ... PRODUCT OVERVIEW. The Celerity HP Biological Indicators are rapid-read, single-use biological indicators designed to monitor ... Products * Sterile Processing * PRODUCTS SOFTWARE REPAIR SERVICES ONSITE SPD SOLUTIONS OFFSITE SPD SOLUTIONS CERTIFIED PRE- ... The biological indicator is self-contained, reducing the risk of contamination and false positives. Each biological indicator ( ...
  • Relationship between pyrogenicity and bacterial endotoxin contamination on latex products was demonstrated by chemical analysis and biological assays. (
  • Some proteins can be produced either by using a biological manufacturing process or through chemical synthesis. (
  • This document identifies actions that a building owner or manager can implement without undue delay to enhance occupant protection from an airborne chemical, biological, or radiological attack. (
  • The approval was based on "comprehensive review of scientific evidence," including "comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data," the FDA said. (
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  • Conserve energy with Thermo Scientific™ MSC- Advantage™ Class II Biological Safety Cabinets, which combine smart design and extraordinary value with best- in-class energy efficiency, reliability and usability resulting in an overall improvement to operation and maintenance. (
  • Wortmannin, (PI3 Kinase inhibitor) The Wortmannin, (PI3 Kinase inhibitor) controls the biological activity of PI3 Kinase. (
  • CARM1 Inhibitor The CARM1 Inhibitor controls the biological activity of CARM1. (
  • EMA classifies a follow-on product as a small molecule or as a biological medicinal product1 based on its own manufacturing process, rather than that of its reference product. (
  • This session was recorded as part of FDLI's Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in October 2023. (
  • The centers are part of an eight-year research program for biological medicines totaling SEK 320 million in the years 2016-2023. (
  • An important objective of the research program for biological medicines was to establish strong research and development environments in biological medicines in order to make Sweden a leader in the field. (
  • Reference via Wikipedia ] Biological Informatics 2020 is a comprehensive listing of biological informatics resources currently available on the Internet. (
  • The BioBrowser window contains commands and features specific for analyzing biological molecules including Biomass Calculation and Biomass Deconvolution.BIOMASS CalculationBIOMASS Calculation is used in the analysis and interpret. (
  • 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. (
  • The Celerity HP Biological Indicators are rapid-read, single-use biological indicators designed to monitor vaporized hydrogen peroxide (VH2O2) sterilization processes. (
  • While every care has been taken to ensure product information is correct, food products are constantly being reformulated, so ingredients, nutrition content, dietary and allergens may change. (
  • Cabinets are certified to EN 12469 safety standard. (
  • Purifier Logic+ Class II, Type A2 Biosafety Cabinets provide personnel, product and environmental protection from hazardous particulates such as agents that require Biosafety Level 1, 2 or 3 containment. (
  • These biological safety cabinets are designed to discharge HEPA-filtered exhaust air directly into the laboratory, or into an exhaust system through the optional Canopy Connection. (
  • This resource is an easy-to-follow flow chart of the MyLogic™ Operating System menu that is installed on all Logic®+ Biological Safety Cabinets and PuriCare® Procedure Stations with 8' or 10' sash openings manufactured May 1, 2019 or later. (
  • For Logic®+ Biological Safety Cabinets and PuriCare® Procedure Stations with 12' sash openings, and any Axiom® Biological Safety Cabinet, see MyLogic Operating System Instruction Chart (2013 to 2019). (
  • This flow chart shows certifiers how to navigate the diagnostic and calibration sections of the MyLogic™ Operating System on Logic®+ Biological Safety Cabinets and PuriCare® Procedure Stations with 8' or 10' sash openings manufactured May 1, 2019 or later. (
  • Thanks to these three centers, Sweden has established a good foundation for taking a leading position in biological medicines and advanced therapies. (
  • Today, the centers are important components of the Swedish ecosystem for biological medicines and advanced therapies. (
  • These VH2O2 biological indicators provide a final read within 5 minutes (LCB052) or 20 minutes (LCB044) of incubation, so you can help keep your operating room (OR) on schedule. (
  • The Celerity HP Biological Indicators have been validated for use in all cycles on the STERRAD 100NX (with and without ALLClear Technology), STERRAD NX (with and without ALLClear Technology) and STERRAD 100S Sterilizers. (
  • PCO Choice is a pet friendly, nontoxic, outdoor pest control product that will take care of insects without exposing the pets and family to nerve toxic agents found in widely used pesticides. (
  • Biological experiment gardens receive training, practicum and environmental education services for students, students and the community. (
  • If you have any queries, or you'd like advice on any Tesco brand products, please contact Tesco Customer Services, or the product manufacturer if not a Tesco brand product. (
  • Found 217 biological microscope Sourcing Services , biological microscope Manufacturers and Sourcing Agent. (
  • Please let us know what you think of our products and services. (
  • Is your Labconco product functioning properly? (
  • Product Service is ready to help with installation questions, troubleshooting and replacement parts for your existing Labconco equipment. (
  • This video will explain how to safely operate your Labconco Logic+ or Axiom biological safety cabinet. (
  • The supplier does not provide quotations for this product through SelectScience. (
  • Vinnova invests another 12 million in three important centers for biological medicines. (
  • The program will contribute to competence development, innovation and competitiveness with the goal that Sweden will be a leader in the development and production of biological medicines. (
  • The first center in biological medicines in Sweden, which today is internationally recognized and has been the platform behind many important investments in the field. (
  • The center conducts extensive research in areas relevant to the development of biological medicines. (
  • The research contributes important data to the development of new biological medicines. (
  • The biological indicator is self-contained, reducing the risk of contamination and false positives. (
  • Biological factors include different forms of disease organisms in food and water, and those that can be transmitted by insects and animals, and person-to-person contact. (
  • To address this, we suggest that all follow-on products to biological medicinal products be treated in a consistent manner following biosimilar principles for the review and registration in EU. (
  • Ustekinumab-auub was also granted an interchangeability designation, meaning that, depending on state law, a pharmacist may substitute the biosimilar for the reference product without consulting the prescribing provider. (
  • Biological half-life (elimination half-life, pharmacological half-life) is the time taken for concentration of a biological substance (such as a medication) to decrease from its maximum concentration (Cmax) to half of Cmax in the blood plasma. (
  • The APIMF procedure is one of four ways to provide information on the preparation control and stability of an API intended for use in a prequalified finished pharmaceutical product (FPP). (
  • We offer top-notch chemistry supplies and AP® Chemistry products, backed by our expert technical support. (
  • Janice Smith's OrganicChemistry with Biological Topics continues to breathe new life into theorganic chemistry world. (
  • Because of the close relationship between chemistry and manybiological phenomena, Organic Chemistry with Biological Topics presentsan approach to traditional organic chemistry that incorporates the discussionof biological applications that are understood using the fundamentals oforganic chemistry. (
  • Earlier this month, Alfa Chemistry unveiled a new product line of colloidal materials for scientists engaged in relevant research providing customers across the globe with easy access to comprehensive colloidal materials, including: colloidal catalysts, colloidal nanoparticles, hydrocolloids, and colloidal silica. (
  • Consumers can buy synthetic cannabinoids in convenience stores, from individual drug dealers, friends, or online as incense or natural herbal products. (
  • The current working hypothesis is that brodifacoum was mixed with synthetic cannabinoids products. (
  • The center works to improve formulation and processing for the production of biological drugs. (
  • Policy statements from the American Academy of Pediatrics benefit from expertise and resources of liaisons and internal (AAP) and son, without preference for one product or formulation over another. (
  • This article aims to reintroduce readers to biologically based and tissue-engineered wound management products. (
  • It also examines two well-established wound management interventions, topical negative pressure therapy and larval therapy, which could have a positive effect on the outcome of biologically based and tissue-engineered wound management products. (
  • After loss of exclusivity follow-on products could use one of the two manufacturing principles and, in EU, both chemically synthesized and biologically produced follow-ons are allowed to reference a biological originator. (
  • The relationship between the biological and plasma half-lives of a substance can be complex depending on the substance in question, due to factors including accumulation in tissues, protein binding, active metabolites, and receptor interactions. (
  • Today's approval exemplifies the FDA's longstanding commitment to support a competitive marketplace for biological products," Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research, said in a statement . (
  • This bachelor of science (BSc) program is for students who are interested in using physical approaches to tackle biological problems. (
  • LAMPIRE provides high quality, competitively priced biological raw materials for research, diagnostic and manufacturing use including Donor and Abattoir Animal Blood, Tissues, Glands and Organs. (
  • LAMPIRE also supplies Human Blood Products, Components and Specialty Products. (
  • The Celerity HP Biological Indicator provides rapid results in as little as five minutes, so you can have confidence when releasing loads per facility policy after VH2O2 sterilization. (
  • Industry service publication provides helpful information on choosing the right biological safety cabinet for your application. (
  • Biological experiment garden is one of the work units in the Biology Department FMIPA UNM which functions to support the implementation of lectures, especially the practicum of various courses that are relevant for students majoring in biology. (
  • Clinical use and quality control of human blood products : from international meeting held in Rome, Istituto superiore di sanità on 3-5 May 1979. (
  • Each biological indicator (BI) vial is inoculated with Geobacillus stearothermophilus bacterial spores and contains a defined media within the vial cap. (
  • Dose the product using the cap. (
  • Speak with a healthcare provider to find out what type of product and dose might be best for a specific condition. (
  • Unless otherwise stated in our catalog or other company documentation accompanying the product(s), our products are intended for research use only and are not to be used for any other purpose, which includes but is not limited to, unauthorized commercial uses, in vitro diagnostic uses, ex vivo or in vivo therapeutic uses or any type of consumption or application to humans or animals. (
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  • Credit card payment only is accepted for this order because it contains a mix of both publications and training products. (
  • In order to use prescribed burning, often managers must provide estimates of the quantity of certain combustion products that will be produced before air quality regulators issue bum permits because prescribed bums release a significant amount of particles into the atmosphere (Chi et al 1979, Levine 1996, Goldammer et al 2009). (
  • ConnectAssure Technology Data Export software helps promote compliance throughout the facility by interfacing compatible STERIS products with SPM Surgical Asset Tracking Software and many of the other leading instrument tracking systems. (
  • Bioinformatics is an interdisciplinary field that develops methods and software tools for understanding biological data, in particular when the data sets are large and complex. (
  • Several anti-diabetic strategies including adiponectin, ezetimibe, liraglutide, taurine, adipose tissue-derived stem cells (ADSCs) and even exercise as well as natural products such GABA tea, geniposide, guava extract, vitamin D have been shown to target autophagy. (
  • Subsequent testing of drug and biological samples from case-patients detected the presence of brodifacoum, a long-acting vitamin K-dependent antagonist that is used as a rodenticide (4). (
  • With this project, I intend to investigate the variation of bioactive pigments and biological activity along the growth curve of the T. suecica (HCMR). (
  • These biological properties, including pyrogenicity, completely disappeared by treating the pyrogenic extracts with endotoxin-adsorbent affinity column. (