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

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/356874/2017
Effective from01/08/2018
KeywordsBioequivalence, generics, dolutegravir
DescriptionThis document provides product-specific guidance on the demonstration of the bioequivalence of olutegravir.
  • 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

In operation: 01/08/2018-present


Published: 28/07/2017

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