Statistical Approaches to Establishing Bioequivalence

Issue Date: May 29, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Biopharmaceutics, Generic Drugs
Status: Final

Statistical Approaches to Establishing Bioequivalence

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 This guidance finalizes the draft guidance of the same title issued on December 5, 2022, and replaces the guidance of the same title issued on February 2, 2001.

Download the Guidance Document