Paliperidone palmitate 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 palmitate depot suspension for injection 25 mg, 50 mg, 75 mg, 100 mg and 150 mg product-specific bioequivalence guidance (PDF/147.28 KB)
Adopted
First published: 03/03/2017
Last updated: 03/03/2017
Legal effective date: 01/09/2017
EMA/CHMP/474825/2016 -
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Overview of comments received on Paliperidone palmitate depot suspension for injection 25 mg, 50 mg, 75 mg, 100 mg and 150 mg product-specific bioequivalence guidance (EMA/CHMP/474825/2016) (PDF/147.91 KB)
First published: 03/03/2017
Last updated: 03/03/2017
Legal effective date: 01/09/2017
EMA/CHMP/810545/2016 -
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Draft paliperidone palmitate depot suspension for injection 25, 50, 75, 100 and 150 mg product-specific bioequivalence guidance (PDF/87.92 KB)
Draft: consultation closed
First published: 01/08/2016
Last updated: 01/08/2016
Consultation dates: 01/08/2016 to 31/10/2016
EMA/CHMP/474825/2016