Imatinib product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of imatinib.
Keywords: Bioequivalence, generics, imatinib
Abbreviations:
- BCS Classification: Biopharmaceutics Classification System
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
- Cmax: maximum plasma concentration
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Overview of comments received on 'Draft imatinib product-specific bioequivalence guidance' (PDF/141.68 KB)
First published: 10/04/2015
Last updated: 10/04/2015
EMA/CHMP/116042/2014 -
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Draft imatinib product-specific bioequivalence guidance (PDF/80.92 KB)
Draft: consultation closed
First published: 15/11/2013
Last updated: 15/11/2013
Consultation dates: 15/11/2013 to 15/02/2014
CHMP/PKWP/EMA/423733/2013