Sorafenib product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of sorafenib. The revision concerns clarification on high intra-subject variability but does not imply new requirements.
Keywords: Bioequivalence, generics, sorafenib
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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Sorafenib film-coated tablets 200 mg product-specific bioequivalence guidance (PDF/78 KB)
Adopted
First published: 25/05/2016
Last updated: 25/05/2016
Legal effective date: 01/12/2015
EMA/CHMP/315232/2014 -
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Overview of comments received on 'draft sorafenib product-specific bioequivalence guidance' (PDF/112.2 KB)
First published: 07/07/2015
Last updated: 07/07/2015
EMA/CHMP/116717/2014 -
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Draft sorafenib product-specific bioequivalence guidance (PDF/80.38 KB)
Draft: consultation closed
First published: 15/11/2013
Last updated: 15/11/2013
Consultation dates: 15/11/2013 to 15/02/2014
CHMP/PKWP/EMA/423707/2013