Table 1

Preclinical development acronyms

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


Steinmetz and Spack BMC Neurology 2009 9(Suppl 1):S2   doi:10.1186/1471-2377-9-S1-S2

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