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
• 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

Gefitinib film-coated tablet 250 mg product-specific bioequivalence guidance

AdoptedReference Number: EMA/CHMP/257026/2018Legal effective date: 01/02/2020

Document history

Draft gefitinib film-coated tablet 250 mg product-specific bioequivalence guidance

Draft: consultation closedConsultation dates: 27/06/2018 to 30/09/2018Reference Number: EMA/CHMP/257026/2018