Ezetimibe product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of ezetimibe tablet 10 mg.

Keywords: Bioequivalence, generics, ezetimibe

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

Ezetimibe tablet 10 mg product-specific bioequivalence guidance

AdoptedReference Number: EMA/CHMP/802491/2018Legal effective date: 01/04/2020

Overview of comments received on 'Ezetimibe tablet 10 mg product-specific bioequivalence guidance' (EMA/CHMP/802491/2018)

Reference Number: EMA/CHMP/401588/2019

Document history

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft: consultation closedConsultation dates: 21/12/2018 to 30/06/2019Reference Number: EMA/CHMP/802491/2018Summary:

This document provides product-specific guidance on the demonstration of the bioequivalence of ezetimibe tablet 10 mg.