Rilpivirine product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the rilpivirine.
Keywords: Bioequivalence, generics, rilpivirine
Abbreviations:
- 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
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Overview of comments received on ‘Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance’ (EMA/CHMP/356878/2017) - First version (PDF/84.12 KB)
First published: 01/02/2018
Last updated: 01/02/2018
EMA/CHMP/730771/2017 -
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Draft rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance - First version (PDF/76.63 KB)
Draft: consultation closed
First published: 28/07/2017
Last updated: 28/07/2017
Consultation dates: 28/07/2017 to 31/10/2017
EMA/CHMP/356878/2017