Dasatinib product-specific bioequivalence guidance

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Current effective version

Adopted guideline

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

First version

Current version

Adopted guideline


Draft guideline

In operation: 01/06/2015–present


Published: 15/11/2013


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