Glossary Overview
GCLP: The Good Clinical Laboratory Practice
GxP: Good-x-Practice
GLP: Good Laboratory Practice
GCP: Good Clinical Practice
GMP: Good Manufacturing Practice
GAMP: Good Automated Manufacturing Practice
ICH: The International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use (ICH) - Quality (Q), Safety (S), Efficacy (E), Multidisciplinary (M)
EMA: European Medicines Agency (Regulatory authorities in Europe)
FDA: Food Drug Administration
OECD: The Organization for Economic Co-operation and Development
USP: The United State Pharmacopeia (Compendium of drug information for the United States)
QA: Quality Assurance
QC: Quality Control
DQI: Drug Quality and Information
PQM: Promoting the Quality of Medicines
CRO: Contract Research Organizations
ROI: Return On Investment
HPLC: High-Performance Liquid Chromatography, High-Pressure Liquid Chromatography
UPLC: Ultra Performance Liquid Chromatography
ICP-MS: Inductively Coupled Plasma Mass Spectrometery
GTT: Glucose Tolerance Test
OGTT: Oral Glucose Tolerance Test
IPGTT: Interaperitoneally Glucose Tolerance Test
IVGTT: Intravenously Glucose Tolerance Test
IC50: The concentration needed to inhibit a biological or biochemical function by half
Pharmacokinetics: The process by which a substance is absorbed, distributed, metabolized, and eliminated by the body.
Pharmacokinetics parameters: Cinitial, Cmax, Tmax, t1/2, AUC, CL, Vz, Vd, f, F
Cinitial: Calculated initial concentration following intravenous administration
Cmax: Maximal concentration after extravascular administration
Tmax: Time to reach Cmax
t1/2: Elimination half life
AUC: Area under the curve
CL: Clearance, Volume of plasma, cleared of the drug/time unit
Vz, Vd: Volume of distribution, theoretical volume in which a drug is distributed
f, F: bioavailability, fraction of drug absorbed
Pharmacodynamics: The monitoring of biochemical and physiological effects of drugs on the body (e.g., stimulating or inhibition action)
LIMS: Laboratory Information Management System - Highly specialized, protocol-driven software application
DMPK: Drug Metabolism and Pharmacokinetic
CFR: Code of Federal Regulations (Title 21 Food and Drugs)
Chapter I- Food and Drug Administration, Department of Health and Human Services
Chapter II-Durg Enforcement Administration, Department of Justice
Chapter III-Office of National Drug Control Policy
OFR: Office of the Federal Register
ELISA: Enzyme-linked Immunosobent Assay
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