Prasugrel product-specific bioequivalence guidance

Current effective version

PDF iconAdopted guideline

Adopted guideline enters into effect 01/12/2018 - see below

Reference number EMA/CHMP/158772/2016
Published 27/05/2016
Effective from 01/11/2016
Keywords Bioequivalence, generics, prasugrel
Description This document provides product-specific guidance on the demonstration of the bioequivalence of prasugrel.
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

In progress

PDF iconAdopted guideline



PDF iconOverview of comments


PDF iconDraft guideline

Published: 26/06/2018
Effective from: 01/12/2018

Published: 26/06/2018

Published: 03/08/2017

First version

Current version

PDF iconAdopted guideline

 

PDF iconOverview of comments

 

PDF iconDraft guideline

In operation: 01/11/2016

 

Published: 07/04/2016

 

Published: 15/07/2015


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