Dabigatran etexilate, hard capsules, 75 mg, 110 mg and 4 150 mg product-specific bioequivalence guidance

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Current version

Draft guideline

Deadline for comments: 31/03/2017

Reference numberEMA/CHMP/805498/2016
Published22/12/2016
Effective from 
KeywordsBioequivalence, generics, dabigatran etexilate
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of dabigatran etexilate.
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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