Voriconazole product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of voriconazole.

Keywords: Bioequivalence, generics, voriconazole

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 version

Voriconazole tablets 50, 200 mg and powder for oral suspension 40 mg/ml product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/123572/2025 Rev.1 Legal effective date: 01/11/2025

Document history

Voriconazole tablets 50, 200 mg and powder for oral suspension 40 mg/ml product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/315236/2014 Legal effective date: 01/12/2015 Summary:

This document provides product-specific guidance on demonstration of bioequivalence of voriconazole

Overview of comments received on 'draft voriconazole product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/116571/2014

Draft voriconazole product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/11/2013 to 15/02/2014 Reference Number: CHMP/PKWP/EMA/422408/2013 Summary:

Voriconazole product-specific bioequivalence guidance