Elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil.

Keywords: Bioequivalence, generics, elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil

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

Current effective version

Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil film-coated tablets 150 mg/150 mg/200 mg/245 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/805518/2016 Legal effective date: 01/01/2018

Document history

Draft elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil film-coated tablets 150 mg/150 mg/200 mg/ 245 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 22/12/2016 to 31/03/2017 Reference Number: EMA/CHMP/805518/2016 Summary:

This document provides product-specific guidance on the demonstration of the bioequivalence of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.