Asenapine product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of asenapine.
Keywords: Bioequivalence, generics, asenapine
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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Overview of comments on 'Asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance' (PDF/102.28 KB)
First published: 01/04/2016
Last updated: 01/04/2016
EMA/CHMP/162825/2016 -
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Draft asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance (PDF/80.49 KB)
Draft: consultation closed
First published: 15/07/2015
Last updated: 15/07/2015
Consultation dates: 15/07/2015 to 01/11/2015
EMA/CHMP/PKWP/269533/2015