Dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

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Current version

Adopted guideline

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

Reference numberEMA/CHMP/421315/2017
Published03/08/2017
Effective from01/12/2018 
KeywordsBioequivalence, generics, dimethyl fumarate
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of dimethyl fumarate.
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


 

Draft guideline

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

 

Published: 03/08/2017

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