1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Statistical Approaches to Establishing Bioequivalence
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Statistical Approaches to Establishing Bioequivalence May 2026

Download the Final Guidance Document
Final Level 1 Guidance
Docket Number:
FDA-2001-D-0197
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Statistical Approaches to Establishing Bioequivalence.” This guidance provides recommendations to sponsors and applicants planning to use equivalence criteria in analyzing bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and amendments and supplements to these applications. The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. This guidance finalizes the draft guidance of the same title issued on December 5, 2022, and replaces the guidance of the same title issued on February 2, 2001.

Submit Comments

Submit Comments Online

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.

Back to Top