Industry Terms
- Abbreviated New Drug Application (ANDA)
- Application made by a company to the U.S. Food and Drug Administration to market the generic version of a branded drug. The duplicate drug must be biologically or chemically equivalent to the branded version of the drug. The first company to receive FDA approval of an ANDA receives 180 days of market exclusivity for the generic drug.
- Absorption, distribution, metabolism and excretion/toxicology (ADME/T)
- ADME/T testing aims to measure what happens to a compound when it enters human physiology. These tests are done during the preclinical stage of the drug discovery process and are required before and investigational new drug application (INDA), which authorizes the company to administer an investigational drug to humans, is filed.
- Active pharmaceutical ingredient (API)
- Any substance or mixture of substances that is an active ingredient intended for use in the making of a drug product. APIs are intended to cause a direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body.
- Adaptive clinical trials
- These types of trials offer more flexible methods for design and monitoring to help speed up time to market.
- Adverse drug reaction (ADR)
- An undesirable effect associated with the use of a drug. It may either be a standard part of the drug’s action or an unpredicted effect.
- Agonist
- An agonist is a substance or drug that can interact with a receptor and initiate a characteristic physiological or pharmacological response.
- Amino acids
- An organic compound containing an amino group (NH2), a carboxylic acid group (COOH) and any of various side groups, especially any of the 20 compounds that have the basic formula NH2CHRCOOH, and that link together by peptide bonds to form proteins or that function as chemical messengers and as intermediates in metabolism.
- Ampoule (ampule)
- A small glass vial that is sealed after filling and used chiefly as a container for a hypodermic injection solution.
- Analyte specific reagent
- These reagents are a class of regulated product that are usually a singular reagent, such as an antibody, which can be used toward developing a test by others. The intention is to sell it as an independent reagent. It is exempt from 501(k) requirements.
- Antagonist
- A drug or compound that opposes the physiological effects of another drug.
- Antibiotic
- An organic or synthetically produced substance of microbial origin that is either toxic to or inhibits the growth of other organisms.
- Antibody
- A protein molecule and protective mechanism in the blood serum and other bodily fluids produced by the immune system in response to exposure to a foreign substance.
- Aseptic processing
- In an aseptic process, the drug product, container and closure are sterilized separately and then brought together. Each process requires separate validation and control.
- Assay
- A set of operations to determine the value of a quantity. In analytical chemistry, this term is synonymous with measurement.
- Attrition
- The early removal of poor drug candidates and the emphasis on lead optimization.
- Auto-injector
- A device used to administer a preset dose of medication.
- Autosampler
- Automated sample loader, usually robotic, used with chromatography and other analytical technologies.
