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