The European Medicines Agency has published for public consultation an ICH Guideline M13A on 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.
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. Comments should be provided using this template and sent to ich@ema.europa.eu by 26 May 2023.
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- The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
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