EMA/ICH – The ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms has been adopted
The ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms has been fully adopted on 23 July 2024.
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 dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. 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.
The new ICH M13A guideline comes with a Questions and answers in order to “to provide clarity on concepts related to the evaluation of bioequivalence for immediate-release solid oral dosage forms as covered in the Guideline. This Q&A document is intended to offer additional clarification and improve harmonization“.
More information on the ICH as well as on the EMA Website.
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vroby (19 octobre 2024). EMA/ICH – The ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms has been adopted. ELSIBI. Consulté le 18 mars 2025 à l’adresse https://doi.org/10.58079/12j9d