Federal Register #FDA2001D0197

FDA Final Guidance on Statistical Approaches to Bioequivalence

This notice announces the release of a final guidance document by the Food and Drug Administration (FDA) regarding statistical approaches to establishing bioequivalence in drug applications. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are mentioned, as this is a regulatory guidance notice, not a procurement. - No products or services are being requested; the notice pertains to policy guidance for industry. - Key details: - Guidance applies to sponsors and applicants for INDs, NDAs, ANDAs, and related amendments/supplements. - Covers statistical methods for bioequivalence studies, including for narrow therapeutic index drugs, highly variable drugs, missing data, and outlier detection. - Finalizes and replaces previous draft and 2001 guidance documents. - No purchase quantities, part numbers, or unique technical requirements are specified, as this is not a solicitation.

Description

The Food and Drug Administration (FDA) announces the availability of a final guidance for industry titled "Statistical Approaches to Establishing Bioequivalence." This guidance provides recommendations for sponsors and applicants on using equivalence criteria in analyzing bioequivalence studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and related amendments and supplements. It discusses statistical approaches for bioequivalence comparisons, including specific situations such as narrow therapeutic index drugs and highly variable drugs, and addresses missing data and outlier detection. The guidance finalizes a draft issued in 2022 and replaces the guidance issued in 2001.

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