Posaconazole product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of posaconazole gastro-resistant tablet 100 mg.
Keywords: Bioequivalence, generics, posaconazole
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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Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance (PDF/91.2 KB)
Adopted
First published: 03/08/2018
Last updated: 03/08/2018
EMA/CHMP/800785/2017 -
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Draft posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance (PDF/84.14 KB)
Draft: consultation closed
First published: 31/01/2018
Last updated: 31/01/2018
Consultation dates: 31/01/2018 to 30/04/2018
EMA/CHMP/800785/2017