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Statistical Approaches to Establishing Bioequivalence December 2022


Not for implementation. Contains non-binding recommendations.

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

Requirements for submitting bioavailability (BA) and bioequivalence (BE) data in investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements; the definitions of BA and BE; and the types of in vitro and in vivo studies that are appropriate to measure BA and establish BE are set forth in part 320 (21 CFR part 320). This guidance provides recommendations on how to meet provisions of part 320 for all drug products.

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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: FDA-2001-D-0197.

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