Rilpivirine product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, rilpivirine

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

Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance - First version

AdoptedReference Number: EMA/CHMP/356878/2017Legal effective date: 01/08/2018Summary:

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

Document history

Overview of comments received on ‘Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance’ (EMA/CHMP/356878/2017) - First version

Reference Number: EMA/CHMP/730771/2017

Draft rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance - First version

Draft: consultation closedConsultation dates: 28/07/2017 to 31/10/2017Reference Number: EMA/CHMP/356878/2017Summary:

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