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# Guides on Bioequivalence Study Designs
- URL: https://www.fdaweb.com/guides-on-bioequivalence-study-designs/
- Published: 2024-10-31T12:00:00.000Z
- Updated: 2026-09-14T14:45:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158101

*Federal Register* notice: FDA is making available a final guidance 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 International Council for Harmonization-developed document describes the scientific and technical aspects of study design and data analysis to support bioequivalence 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 document is intended to clarify concepts covered in the guidance. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-10-31/pdf/2024-25355.pdf?ref=fdaweb.com).