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Animal Efficacy Rule
The Food and Drug Administration (United States), FDA animal efficacy rule (also known as animal rule) applies to Drug development, development and testing of drugs and biopharmaceutical, biologicals to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (Chemical agent, chemical, Biological agent, biological, Radiological weapon, radiological, or nuclear substances), where human efficacy Clinical trial, trials are not feasible or Clinical research ethics, ethical. The animal efficacy rule was finalized by the FDA and authorized by the United States Congress in 2002, following the September 11 attacks and concerns regarding bioterrorism. Summary The FDA can rely on evidence from Animal testing, animal studies to provide substantial evidence of product effectiveness if: # There is a reasonably well-understood mechanism for the toxicity of the agent and its amelioration or prevention by the product; # The effect ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration (United States)
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying fro ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Endpoint
Clinical endpoints or clinical outcomes are Outcome measure, outcome measures referring to occurrence of disease, symptom, Medical sign, sign or laboratory abnormality constituting a target outcome in clinical trial, clinical research trials. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then often termed a ''humane (clinical) endpoint''. The primary endpoint of a clinical trial is the endpoint for which the trial is statistical power, powered. Secondary endpoints are additional endpoints, preferably also pre-specified, for which the trial may not be powered. Surrogate endpoint, Surrogate endpoints are trial endpoints that have outcomes that substitute for a clinical endpoint, often because studying the clinical endpoint is difficult, for example using an increase in blood pressure as a surrogate for death by cardiovascular disease, where strong evidence of a causal link exists. Scope In a general sens ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional drug ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Life Sciences Industry
Life is a quality that distinguishes matter that has biological processes, such as signaling and self-sustaining processes, from that which does not, and is defined by the capacity for growth, reaction to stimuli, metabolism, energy transformation, and reproduction. Various forms of life exist, such as plants, animals, fungi, protists, archaea, and bacteria. Biology is the science that studies life. The gene is the unit of heredity, whereas the cell is the structural and functional unit of life. There are two kinds of cells, prokaryotic and eukaryotic, both of which consist of cytoplasm enclosed within a membrane and contain many biomolecules such as proteins and nucleic acids. Cells reproduce through a process of cell division, in which the parent cell divides into two or more daughter cells and passes its genes onto a new generation, sometimes producing genetic variation. Organisms, or the individual entities of life, are generally thought to be open systems that ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biotechnology
Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used by Károly Ereky in 1919, meaning the production of products from raw materials with the aid of living organisms. Definition The concept of biotechnology encompasses a wide range of procedures for modifying living organisms according to human purposes, going back to domestication of animals, cultivation of the plants, and "improvements" to these through breeding programs that employ artificial selection and hybridization. Modern usage also includes genetic engineering as well as cell and tissue culture technologies. The American Chemical Society defines biotechnology as the application of biological organisms, systems, or processes by various industries to learning about the science of life and the improvement of the value of materials ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biotechnology Products
Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used by Károly Ereky in 1919, meaning the production of products from raw materials with the aid of living organisms. Definition The concept of biotechnology encompasses a wide range of procedures for modifying living organisms according to human purposes, going back to domestication of animals, cultivation of the plants, and "improvements" to these through breeding programs that employ artificial selection and hybridization. Modern usage also includes genetic engineering as well as cell and tissue culture technologies. The American Chemical Society defines biotechnology as the application of biological organisms, systems, or processes by various industries to learning about the science of life and the improvement of the value of materials ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biopharmaceuticals
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms ''biological me ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bioethics
Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, medicine and technologies. It proposes the discussion about moral discernment in society (what decisions are "good" or "bad" and why) and it is often related to medical policy and practice, but also to broader questions as environment, well-being and public health. Bioethics is concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, theology and philosophy. It includes the study of values relating to primary care, other branches of medicine ( "the ethics of the ordinary"), ethical education in science, animal, and environmental ethics, and public health. Etymology The term ''Bioethics'' (Greek , life; , behavior) was coined in 1927 by Fritz Jahr in an article about a "b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biological Contamination
A biological hazard, or biohazard, is a biological substance that poses a threat to the health of living organisms, primarily humans. This could include a sample of a microorganism, virus or toxin that can adversely affect human health. A biohazard could also be a substance harmful to other animals. The term and Hazard symbol#Biohazard sign, its associated symbol are generally used as a warning, so that those potentially exposed to the substances will know to take precautions. The biohazard symbol was developed in 1966 by Charles Baldwin, an environmental-health engineer working for the Dow Chemical Company on the containment products. It is used in the labeling of biological materials that carry a significant health risk, including viral samples and used hypodermic needles. In Unicode, the biohazard symbol is U+2623 (☣). ANSI Z535/OSHA/ISO regulation Biohazardous safety issues are identified with specified labels, signs and paragraphs established by the American National ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biological Warfare
Biological warfare, also known as germ warfare, is the use of biological toxins or infectious agents such as bacteria, viruses, insects, and fungi with the intent to kill, harm or incapacitate humans, animals or plants as an act of war. Biological weapons (often termed "bio-weapons", "biological threat agents", or "bio-agents") are living organisms or replicating entities ( ''i.e.'' viruses, which are not universally considered "alive"). Entomological (insect) warfare is a subtype of biological warfare. Offensive biological warfare is prohibited under customary international humanitarian law and several international treaties. In particular, the 1972 Biological Weapons Convention (BWC) bans the development, production, acquisition, transfer, stockpiling and use of biological weapons. Therefore, the use of biological agents in armed conflict is a war crime. In contrast, defensive biological research for prophylactic, protective or other peaceful purposes is not proh ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Effective Dose (pharmacology)
In pharmacology, an effective dose (ED) or effective concentration (EC) is a dose or concentration of a medication, drug that produces a biological response. The term effective dose is used when measurements are taken ''in vivo,'' while the term effective concentration is used when the measurements are taken ''in vitro''. Paracelsus#Toxicology, It has been stated that any substance can be toxic at a high enough dose. This concept was exemplified in 2007 when a California woman died of water intoxication in KDND#"Hold Your Wee for a Wii" contest, a contest sanctioned by a radio station. The line between efficacy and toxicity is dependent upon the particular patient, although the dose administered by a physician should fall into the predetermined therapeutic window of the drug. The importance of determining the therapeutic range of a drug cannot be overstated. This is generally defined by the range between the minimum effective dose (MED) and the maximum tolerated dose (MTD). The M ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmacodynamics
Pharmacodynamics (PD) is the study of the biochemical and physiologic effects of drugs (especially pharmaceutical drugs). The effects can include those manifested within animals (including humans), microorganisms, or combinations of organisms (for example, infection). Pharmacodynamics and pharmacokinetics are the main branches of pharmacology, being itself a topic of biology interested in the study of the interactions between both endogenous and exogenous chemical substances with living organisms. In particular, pharmacodynamics is the study of how a drug affects an organism, whereas pharmacokinetics is the study of how the organism affects the drug. Both together influence dosing, benefit, and adverse effects. Pharmacodynamics is sometimes abbreviated as PD and pharmacokinetics as PK, especially in combined reference (for example, when speaking of PK/PD models). Pharmacodynamics places particular emphasis on dose–response relationships, that is, the relationships between d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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