Lapatinib product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of lapatinib film-coated tablet 250 mg. 

Keywords: Bioequivalence, generics, lapatinib

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