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 |