Gefitinib product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, gefitinib

Abbreviations: 

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• C_max: maximum plasma concentration