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

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Current version

Draft guideline

 

Deadline for comments: 31/10/2017

Reference numberEMA/CHMP/421315/2017
Published03/08/2017
Effective from 
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


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