46 relations: Accelerated approval (FDA), Adverse event, Animal testing, Biological half-life, Case series, Center for Drug Evaluation and Research, Cerivastatin, Chronic condition, Confirmatory trial, Contract research organization, Contrast agent, Crossover study, Dose-ranging study, Drug design, Drug discovery, Efficacy, European Medicines Agency, European Union, Fasting, Food and Drug Administration, Gender-neutral language, Health Canada, HIV, Human subject research, In vitro, In vivo, Investigational New Drug, Lippincott Williams & Wilkins, Microdosing, Ministry of Health, Labour and Welfare, Multicenter trial, New Drug Application, Pharmaceutical industry, Pharmacodynamics, Pharmacokinetics, Pharmacovigilance, Postmarketing surveillance, Pre-clinical development, Public health intervention, Randomized controlled trial, Rofecoxib, Terminal illness, Therapeutic index, Therapy, Toxicity, Troglitazone.
The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Animal testing, also known as animal experimentation, animal research and in vivo testing, is the use of non-human animals in experiments that seek to control the variables that affect the behavior or biological system under study.
The biological half-life of a biological substance is the time it takes for half to be removed by biological processes when the rate of removal is roughly exponential.
A case series (also known as a clinical series) is a type of medical research study that tracks subjects with a known exposure, such as patients who have received a similar treatment, or examines their medical records for exposure and outcome.
The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
Cerivastatin (INN, brand names: Baycol, Lipobay) is a synthetic member of the class of statins used to lower cholesterol and prevent cardiovascular disease.
A chronic condition is a human health condition or disease that is persistent or otherwise long-lasting in its effects or a disease that comes with time.
A confirmatory trial is an adequately controlled trial where hypotheses are stated in advance and evaluated according to a protocol.
A contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.
A contrast agent (or contrast medium) is a substance used to increase the contrast of structures or fluids within the body in medical imaging.
A crossover study, also referred to as a crossover trial, is a longitudinal study in which subjects receive a sequence of different treatments (or exposures).
A dose-ranging study is a clinical trial where different doses of an agent (e.g. a drug) are tested against each other to establish which dose works best and/or is least harmful.
Drug design, often referred to as rational drug design or simply rational design, is the inventive process of finding new medications based on the knowledge of a biological target.
In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which new candidate medications are discovered.
Efficacy is the ability to get a job done satisfactorily.
The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products.
The European Union (EU) is a political and economic union of EUnum member states that are located primarily in Europe.
Fasting is the willing abstinence or reduction from some or all food, drink, or both, for a period of time.
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
Gender-neutral language or gender-inclusive language is language that avoids bias toward a particular sex or social gender.
Health Canada (Santé Canada) is the department of the government of Canada with responsibility for national public health.
The human immunodeficiency virus (HIV) is a lentivirus (a subgroup of retrovirus) that causes HIV infection and over time acquired immunodeficiency syndrome (AIDS).
Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects.
In vitro (meaning: in the glass) studies are performed with microorganisms, cells, or biological molecules outside their normal biological context.
Studies that are in vivo (Latin for "within the living"; often not italicized in English) are those in which the effects of various biological entities are tested on whole, living organisms or cells, usually animals, including humans, and plants, as opposed to a tissue extract or dead organism.
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Lippincott Williams & Wilkins (LWW) is an imprint of the publishing conglomerate Wolters Kluwer.
Microdosing, or micro-dosing, is a technique for studying the behaviour of drugs in humans through the administration of doses so low ("sub-therapeutic") they are unlikely to produce whole-body effects, but high enough to allow the cellular response to be studied.
The is a cabinet level ministry of the Japanese government.
A multicenter research trial is a clinical trial conducted at more than one medical center or clinic.
The Food and Drug Administration's New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
The pharmaceutical industry (or medicine industry) is the commercial industry that discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as different types of medicine and medications.
Pharmacodynamics is the study of the biochemical and physiologic effects of drugs (especially pharmaceutical drugs).
Pharmacokinetics (from Ancient Greek pharmakon "drug" and kinetikos "moving, putting in motion"; see chemical kinetics), sometimes abbreviated as PK, is a branch of pharmacology dedicated to determining the fate of substances administered to a living organism.
Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
Postmarketing surveillance (PMS) (also post market surveillance) is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.
In drug development, preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected.
A public health intervention is any effort or policy that attempts to improve mental and physical health on a population level.
A randomized controlled trial (or randomized control trial; RCT) is a type of scientific (often medical) experiment which aims to reduce bias when testing a new treatment.
Rofecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that has now been withdrawn over safety concerns.
Terminal illness is an incurable disease that cannot be adequately treated and is reasonably expected to result in the death of the patient.
The therapeutic index (TI; also referred to as therapeutic ratio) is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity.
Therapy (often abbreviated tx, Tx, or Tx) is the attempted remediation of a health problem, usually following a diagnosis.
Toxicity is the degree to which a chemical substance or a particular mixture of substances can damage an organism.
Troglitazone (Rezulin, Resulin, Romozin, Noscal) is an antidiabetic and anti-inflammatory drug, and a member of the drug class of the thiazolidinediones.
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