Oseltamivir product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of oseltamivir.
Keywords: Bioequivalence, generics, oseltamivir
Abbreviations:
- BCS Classification: Biopharmaceutics Classification System
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
- Cmax: maximum plasma concentration
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Oseltamivir hard capsules 30, 45 and 75 mg, powder for oral suspension 6 mg/ml and 12 mg/ml product-specific bioequivalence guidance (PDF/80.05 KB)
Adopted
First published: 25/05/2016
Last updated: 25/05/2016
Legal effective date: 01/10/2015
EMA/CHMP/315246/2014 -
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Overview of comments received on 'Draft oseltamivir product-specific bioequivalence guidance' (PDF/79.47 KB)
First published: 10/04/2015
Last updated: 10/04/2015
EMA/CHMP/116544/2014 -
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Draft oseltamivir product-specific bioequivalence guidance (PDF/80.89 KB)
Draft: consultation closed
First published: 15/11/2013
Last updated: 15/11/2013
Consultation dates: 15/11/2013 to 15/02/2014
CHMP/PKWP/EMA/423665/2013