Sunitinib product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of sunitinib.

Keywords: Bioequivalence, generics, sunitinib

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 effective version

Sunitinib hard capsules 12.5, 25, 37.5 and 50 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/315233/2014 Legal effective date: 01/12/2015 Summary:

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

Document history

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

Reference Number: EMA/CHMP/116836/2014

Draft sunitinib product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 03/12/2013 to 03/03/2014 Reference Number: CHMP/PKWP/EMA/423716/2013 Summary:

Product-specific bioequivalence guidance