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Drug Discovery

TermDefinition
Phase 1 clinical trial Only clinical trail on healthy subjects
Phase 2 clinical trail Determine drug efficacy in up to several hundreds patients and to asses potential side effects
Phase 3 clinical trail Conducted in several hundred to several thousand patients to determine drug safety, efficacy, and risk/benefit ratio
Phase 4 clinical trail Conducted after a drug is marketed
United States Pharmacopeia (USP) Sets drug standards for identity, strength and quality/ purity
Food and drug Administration (FDA) Enforces drug standards and ensure that drugs are safe
Investigational New Drug Application (IND) New drug can be tested in clinical trials
New Drug Application (NDA) New drug is marketed for human use
New Animal Drug Application (NADA) New drug is marketed for animal use
Abbreviated New Drug Application (ANDA) Generic drug is marked for human use
Supplemental New Drug Application (sNDA) New formulation for an already approved drug can be marketed
Biological License Application (BLA) New biological drug (such as protein or vaccine) is marketed for human use
Pharmacology Study of drug action
Toxicology Study of drug adverse effects
Formulation Components and amount of active and inactive ingredients in a drug product or preparation
Pre clinical studies Conducted on animals, when a drug is being developed for human use
Class 1 recall Use of or exposure to the product will cause serious adverse health effect or death
Class 2 recall May cause temporary or reversible adverse health or probability of serious adverse health effect is remote
Class 3 recall Not likely to case adverse health effect
Created by: Angelica P
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