Acenocoumarol product-specific bioequivalence guidance - Scientific guideline

This document provides product-specific guidance on the demonstration of the bioequivalence of Acenocoumarol, tablet, 1 mg and 4 mg.

Keywords: Bioequivalence, generics, acenocoumarol

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

Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/CHMP/512475/2020 Rev. 1 Legal effective date: 01/12/2025

Document history

Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance - First version

Adopted Reference Number: EMA/CHMP/512475/2020 Corr. Legal effective date: 01/04/2022

Draft acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance - First version

Draft: consultation closed Consultation dates: 09/11/2020 to 28/02/2021 Reference Number: EMA/CHMP/512475/2020