Aliskiren product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of aliskiren film-coated tablet 150 mg and 300 mg.
Keywords: Bioequivalence, generics, aliskiren
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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Aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance (PDF/77.87 KB)
Adopted
First published: 13/12/2018
Legal effective date: 01/07/2019
EMA/CHMP/291450/2018 -
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Overview of comments received on 'Aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance' (EMA/CHMP/291450/2018) (PDF/89.64 KB)
First published: 13/12/2018
EMA/CHMP/681421/2018 -
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Draft aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance (PDF/78.59 KB)
Draft: consultation closed
First published: 27/06/2018
Last updated: 27/06/2018
Consultation dates: 27/06/2018 to 30/09/2018
EMA/CHMP/291450/2018