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Table 1 Preclinical development acronyms

From: The basics of preclinical drug development for neurodegenerative disease indications

ADME Absorption, distribution, metabolism, and excretion
API Active pharmaceutical ingredient: any component intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease.
CFR Code of Federal Regulations
CGMP, GMP (Current) good manufacturing practice
CMC Chemistry manufacturing and controls
CoA Certificate of analysis
CRO Contract research organization
CTM Clinical trial material
cmax Maximum plasma concentration
DP Drug product: finished dosage form (for example, tablet, capsule, solution) that contains an active drug ingredient, generally in association with inactive ingredients
DS Drug substance: any substance that is represented for use in a drug and that, when used in manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished drug form
FDA US Food and Drug Administration
FIH First in human
FRS Foreign related substances
GLP Good laboratory practice
HPLC High performance liquid chromatography
ICH International Conference on Harmonisation
IND Investigational New Drug application
MTD Maximum tolerated dose
NCE New chemical entity
NDA New drug application
NCI National Cancer Institute
NIA National Institute on Aging
NOAEL No observed adverse effect level
PIB Powder in bottle
PK Pharmacokinetics
RAID Rapid Access to Intervention Development (preclinical program)
SBIR Small Business Innovative Research (grant)
STTR Small Business Technology Transfer (grant)
TI Therapeutic Index
TK Toxicokinetic
tmax Time of maximum plasma concentration after dose administration
TTP Target product profile