Tadalafil product-specific bioequivalence guidance

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberEMA/CHMP/315234/2014 Rev.1
Published01/02/2018
Effective from01/02/2018
KeywordsBioequivalence, generics, tadalafil
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of tadalafil.
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 iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

In operation:01/08/2018-present

Published: 01/02/2018

Published: 03/08/2017

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 01/12/2015–present


Published: 07/07/2015


Published: 15/11/2013


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