Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance

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Current effective version

Adopted guideline

Adopted guideline enters into effect 01/08/2018 - see below

Reference numberEMA/CHMP/356875/2017
Published01/02/2018
Effective from01/08/2018
KeywordsBioequivalence, generics, dronedarone
DescriptionThis document provides product-specific guidance on the demonstration of the dronedarone.
Abbreviations
  • BCS Classification: Biopharmaceutics Classification System
  • AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
  • Cmax: maximum plasma concentration


Document history

First version

Current version

Adopted guideline

 

 

Draft guideline

Published: 01/02/2018
Effective from: 01/08/2018

 

Published: 28/07/2017


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