Dasatinib product-specific bioequivalence guidance

Current effective version

PDF iconAdopted guideline

Currently under revision

Reference numberEMA/CHMP/675838/2014
Published10/04/2015
Effective from01/06/2015
KeywordsBioequivalence, generics, dasatinib
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of dasatinib. Please note that no comments have been received for this guideline during the public consultation period.
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


Document history

Revision 1

PDF iconDraft guideline

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

Published: 06/05/2020

Deadline for comments: 31/08/2020

First version

Current version

PDF iconAdopted guideline

 

PDF iconDraft guideline

In operation: 01/06/2015–present

 

Published: 15/11/2013


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