Ticagrelor product-specific bioequivalence guidance

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/177281/2016
Published27/05/2016
Effective from01/11/2016
KeywordsBioequivalence, generics, ticagrelor
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of ticagrelor.
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


Overview of comments


Draft guideline

In operation: 01/11/2016


Published: 07/04/2016


Published: 15/07/2015


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