Sorafenib product-specific bioequivalence guidance

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
• 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

Sorafenib film-coated tablets 200 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/CHMP/315232/2014 Rev.1 Summary:

This document provides product-specific guidance on demonstration of bioequivalence of sorafenib. This revision concerns clarification on high intra-subject variability but does not imply new requirements.

First version

Sorafenib film-coated tablets 200 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/315232/2014 Legal effective date: 01/12/2015 Summary:

This document provides product-specific guidance on demonstration of bioequivalence of sorafenib

Overview of comments received on 'draft sorafenib product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/116717/2014

Draft sorafenib product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/11/2013 to 15/02/2014 Reference Number: CHMP/PKWP/EMA/423707/2013 Summary:

Sorafenib product-specific bioequivalence guidance