Drug Substance
/ˈdrʌɡ ˈsʌbstəns/
Definitions
- (n.) The active ingredient or raw material in a pharmaceutical product that produces the intended therapeutic effect.
The regulatory submission included detailed information about the drug substance used in the medication.
Forms
- drug substance
Related terms
See also
Commentary
Often distinguished from "drug product," the drug substance refers specifically to the active material before formulation or processing.
This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.