Dasatinib product-specific bioequivalence guidance
Table of contents
Product-specific guidance on the demonstration of the bioequivalence of dasatinib has been revised to include the additional requirement for a fed study and the requirements for a suspension.
Keywords: Bioequivalence, generics, dasatinib
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 'Dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg and suspension 10 mg/ml product-specific bioequivalence guidance' - Revision 1 (PDF/189.52 KB)
First published: 07/10/2021
EMA/CHMP/493940/2020 -
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Draft dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg and suspension 10 mg/ml product-specific bioequivalence guidance - Revision 1 (PDF/232.55 KB)
Draft: consultation closed
First published: 06/05/2020
Consultation dates: 04/05/2020 to 31/08/2020
EMA/CHMP/675838/2014/Rev. 1 -
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Dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg product-specific bioequivalence guidance - First version (PDF/77.99 KB)
Adopted
First published: 25/05/2016
Last updated: 25/05/2016
Legal effective date: 01/06/2015
EMA/CHMP/675838/2014