Tadalafil product-specific bioequivalence guidance

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberEMA/CHMP/315234/2014
Published07/07/2015
Effective from01/12/2015
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

In progress

Draft guideline

Published: 03/08/2017

Deadline for comments: 31/10/2017

 

First version

Current version

Adopted guideline


 

Overview of comments


 

Draft guideline

In operation: 01/12/2015–present


 

Published: 07/07/2015


 

Published: 15/11/2013


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