Repaglinide product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of repaglinide. Please note that no comments have been received for this guideline during the public consultation period.

Keywords: Bioequivalence, generics, repaglinide

Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Current version

Repaglinide tablets 0.5, 1 and 2 mg product-specific bioequivalence guidance - Revision 1

AdoptedReference Number: CHMP/PKWP/EMA/123579/2025 Rev. 1Legal effective date: 01/11/2025

Document history

Draft repaglinide tablets 0.5, 1 and 2 mg product-specific bioequivalence guidance - Rev.1

DraftReference Number: EMA/CHMP/675842/2014 Legal effective date: 01/06/2015Summary:

This document provides product-specific guidance on demonstration of bioequivalence of repaglinide

Draft repaglinide product-specific bioequivalence guidance

Draft: consultation closedConsultation dates: 15/11/2013 to 15/02/2014Reference Number: CHMP/PKWP/EMA/422421/2013Summary:

Repaglinide product-specific bioequivalence guidance