Dabigatran etexilate product-specific bioequivalence guidance

Current version

PDF iconAdopted guideline

Reference numberEMA/CHMP/805498/2016
Published22/12/2016
Effective from01/12/2018
KeywordsBioequivalence, generics, dabigatran etexilate
Description

This document provides product-specific guidance on the demonstration of the bioequivalence of dabigatran etexilate. 

This document should be read in conjunction with the questions and answers on product-specific bioequivalence, point 4.12.

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

 

PDF iconOverview of comments

PDF iconDraft guideline

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

 

Published: 26/06/2018

 

Published: 22/12/2016

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