The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "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 This guidance finalizes the draft guidance of the same title issued on December 5, 2022, and replaces the guidance of the same title issued on February 2, 2001.
US Federal Register - FDA Guidance Notices · May 29, 2026
Statistical Approaches to Establishing Bioequivalence; Guidance for Industry
Original title: Statistical Approaches To Establishing Bioequivalence; Guidance for Industry; Availability
FDA finalizes guidance on statistical methods for bioequivalence studies in drug applications, replacing 2001 guidance.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.