Imatinib product-specific bioequivalence guidance - Scientific guideline

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

Keywords: Bioequivalence, generics, imatinib

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

Imatinib hard capsules 50 and 100 mg, film-coated tablets 100 and 400 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/315242/2014 Legal effective date: 01/10/2015 Summary:

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

Document history

Overview of comments received on 'Draft imatinib product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/116042/2014

Draft imatinib product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/11/2013 to 15/02/2014 Reference Number: CHMP/PKWP/EMA/423733/2013 Summary:

Imatinib product-specific bioequivalence guidance