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GUIDANCE DOCUMENT

M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms January 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-0093
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies 4 during both development and post approval phases for orally administered immediate-release (IR) 5 solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, 6 capsules, and granules/powders for oral suspension.

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-0093.

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