Fingolimod product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of fingolimod.
Keywords: Bioequivalence, generics, fingolimod
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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Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance (PDF/174.37 KB)
Adopted
First published: 03/01/2017
Last updated: 09/08/2019
Legal effective date: 01/07/2017
EMA/CHMP/154812/2016 Rev.1 Corr. -
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Overview of comments received on 'Fingolimod capsules 0.5 mg product-specific bioequivalence guidance' (PDF/138.51 KB)
First published: 03/01/2017
Last updated: 03/01/2017
EMA/CHMP/805860/2016 -
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Draft Fingolimod capsules 0.5mg product-specific bioequivalence guidance (PDF/77.63 KB)
Draft: consultation closed
First published: 02/05/2016
Last updated: 02/05/2016
Consultation dates: 02/05/2016 to 31/07/2016
EMA/CHMP/154812/2016