Dolutegravir, film-coated tablet, 10mg, 25mg, 50mg, product-specific bioequivalence guidance

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Current version

Draft guideline

Deadline for comments: 31/10/2017

Reference numberEMA/CHMP/356874/2017
Published28/07/2017
Effective from 
KeywordsBioequivalence, generics, dolutegravir
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of olutegravir.
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


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