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

  • Email
  • Help
Current version

Draft guideline

Deadline for comments: 31/10/2017

Reference numberEMA/CHMP/356874/2017
Effective from 
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

Related content

How helpful is this page?

Average rating:

 Based on 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings

Tell us more