M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms" and the supplemental document entitled "M13A Bioequivalence for Immediate- Release Solid Oral Dosage Forms: Questions and Answers." The guidance and supplemental questions and answers document were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment of orally administered immediate-release solid oral dosage forms of pharmaceutical drugs, such as tablets, capsules, and granules/powders for oral suspension. The supplemental questions and answers document provides clarity to concepts covered in the guidance and rationales behind to facilitate implementation. The guidance is intended to provide globally harmonized scientific recommendations for conducting BE studies during both the development and postapproval phases of immediate-release solid oral dosage forms. The guidance replaces the draft guidance "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms" issued on February 1, 2023.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.