FDA Publishes Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms

Recommendation

1/2 July 2025
Berlin, Germany

Dissolution Testing
Development / Quality Control and in vivo Relevance

On 30 October 2024, the Center for Drug Evaluation and Research within the U.S. Food and Drug Administration has published a Guidance for Industry entitled "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms". It was developed within the Expert Working Group (Multidisciplinary) of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process.

The document is divided into the following main chapters:

I. Introduction
II. General principles in establishing bioequivalence
III. Specific topics
IV. Documentation
Glossary

According to chapter I.A. (Objectives), the "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 dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension."

The document aims to ensure consistency and reliability in demonstrating bioequivalence for these products. "Deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided. Applicants are encouraged to consult the regulatory authority(ies) when an alternate approach is proposed or taken."

Dissolution testing is highlighted as a critical component in evaluating the release profile of a drug from its dosage form, which directly impacts its bioavailability and systemic delivery.

For more information and to access the document, visit the FDA's website.