Dolutegravir product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of olutegravir.

Keywords: Bioequivalence, generics, dolutegravir

Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Revision 1

Dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/226629/2020 Rev. 1 Legal effective date: 01/11/2025

Current effective version

Dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg product-specific bioequivalence guidance - First version

Adopted Reference Number: EMA/CHMP/356874/2017 Legal effective date: 01/08/2018 Summary:

This guidance provides product-specific guidance on the demonstration of the dolutegravir.

Document history

Draft dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg product-specific bioequivalence guidance - First version

Draft: consultation closed Consultation dates: 28/07/2017 to 31/10/2017 Reference Number: EMA/CHMP/356874/2017 Summary:

This document provides product-specific guidance on the demonstration of the bioequivalence of dolutegravir film-coated tablets