Closed consultation
Consultation on the International Council for Harmonisation (ICH) M13B Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Published 2025-05-08.
The ICH Expert Working Group (EWG) for ICH M13B has been drafting the second guideline in the series which describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment for orally administered immediate-release solid oral dosage forms.
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