Dasatinib product-specific bioequivalence guidance

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
• 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

Dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg and suspension 10 mg/ml product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/CHMP/675838/2014/Rev.1* Legal effective date: 01/05/2021

Document history

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

Reference Number: EMA/CHMP/493940/2020

Draft dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg and suspension 10 mg/ml product-specific bioequivalence guidance - Revision 1

Draft: consultation closed Consultation dates: 04/05/2020 to 31/08/2020 Reference Number: EMA/CHMP/675838/2014/Rev. 1 Summary:

Revision 1 of the guideline on dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg and suspension 10 mg/ml product-specific bioequivalence. 

This revision concerns the additional requirement for a fed study and the requirements for a suspension.

Dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg product-specific bioequivalence guidance - First version

Adopted Reference Number: EMA/CHMP/675838/2014 Legal effective date: 01/06/2015 Summary:

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