M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms

Issue Date: October 30, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Multidisciplinary
Status: Final

M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms

This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. Questions and Answers M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms Questions and Answers (PDF – 665 KB)

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