Vemurafenib product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of vemurafenib.
Keywords: Bioequivalence, generics, vemurafenib
Abbreviations:
- BCS Classification: Biopharmaceutics Classification System
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
- Cmax: maximum plasma concentration
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Overview of comments received on 'Vemurafenib film-coated tablets 240 mg product-specific bioequivalence guidance’ (EMA/CHMP/476248/2016) (PDF/103.41 KB)
First published: 03/03/2017
Last updated: 03/03/2017
Legal effective date: 01/09/2017
EMA/CHMP/803499/2016 -
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Draft vemurafenib film-coated tablets 240 mg product-specific bioequivalence guidance (PDF/77.61 KB)
Draft: consultation closed
First published: 01/08/2016
Last updated: 01/08/2016
Consultation dates: 01/08/2016 to 31/10/2016
EMA/CHMP/476248/2016