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Statistical Approaches to Establishing Bioequivalence February 2001

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Statistical Approaches to Establishing Bioequivalence.” This guidance provides recommendations to sponsors and/or applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drug applications (IND’s), new drug applications (NDA’s), abbreviated new drug applications (ANDA’s) and supplements to these applications. The guidance discusses the use of average, population, and individual BE approaches to compare in vivo and in vitro bioavailability (BA) measures. (This guidance replaces the draft guidance that was issued in 1999 entitled “Average, Population, and Individual Approaches to Establishing Bioequivalence.”)

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 01D-0027.

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