Apixaban product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of apixaban film-coated tablet 2.5 and 5 mg.
Keywords: Bioequivalence, generics, apixaban
Abbreviations:
- BCS Classification: Biopharmaceutics Classification System
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- Cmax: maximum plasma concentration
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Apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance (PDF/127.32 KB)
Adopted
First published: 15/10/2019
Legal effective date: 01/02/2020
EMA/CHMP/291499/2018 -
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Overview of comments received on 'Apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance' (EMA/CHMP/291499/2018) (PDF/188.98 KB)
First published: 15/10/2019
EMA/CHMP/681387/2018