Paliperidone product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of paliperidone.
Keywords: Bioequivalence, generics, paliperidone
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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Paliperidone prolonged-release tablet 1.5 mg, 3 mg, 6 mg, 9 mg and 12 mg product-specific bioequivalence guidance (Rev. 1) (PDF/90 KB)
Adopted
First published: 26/06/2018
Last updated: 26/06/2018
Legal effective date: 01/12/2018
EMA/CHMP/156358/2016/Rev. 1 -
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Paliperidone prolonged-release tablet 1.5 mg, 3 mg, 6 mg, 9 mg and 12 mg product-specific bioequivalence guidance (PDF/145.52 KB)
Adopted
First published: 03/01/2017
Last updated: 03/01/2017
Legal effective date: 01/07/2017
EMA/CHMP/156358/2016 -
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Draft paliperidone prolonged-release tablet 1.5mg, 3mg, 6mg, 9mg and 12mg product-specific bioequivalence guidance (PDF/88.29 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/156358/2016