Bioequivalence
/ˌbaɪoʊˌɛkwɪˈvələns/
Definitions
- (n.) The legal and scientific standard determining that two pharmaceutical products have equivalent bioavailability and thereby similar efficacy and safety profiles.
Regulatory agencies require bioequivalence studies before approving generic drugs.
Forms
- bioequivalence
Related terms
See also
Commentary
Bioequivalence is crucial in pharmaceutical law to ensure generics perform similarly to branded drugs without requiring duplicative clinical trials.
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.