Posaconazole product-specific bioequivalence guidance

HumanScientific guidelines

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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
AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
C_max: maximum plasma concentration

Current effective version

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/800785/2017 Summary:

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

English (EN) (91.2 KB - PDF)

Esmakordselt avaldatud: 03/08/2018 Viimati ajakohastatud: 03/08/2018

Document history - First version

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/800785/2017 Summary:

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

English (EN) (91.2 KB - PDF)

Esmakordselt avaldatud: 03/08/2018 Viimati ajakohastatud: 03/08/2018

Draft posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 31/01/2018 to 30/04/2018 Reference Number: EMA/CHMP/800785/2017 Summary:

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

English (EN) (84.14 KB - PDF)

Esmakordselt avaldatud: 31/01/2018 Viimati ajakohastatud: 31/01/2018

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Scientific guidelines