Liposomal amphotericin B product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of liposomal amphotericin B.

Keywords: Bioequivalence, generics, liposomal amphotericin B

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 - effective from 1/07/2023

Liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/559889/2021 Legal effective date: 01/07/2023

Overview of comments received on 'Liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance’ (EMA/CHMP/559889/2021) - Rev. 1

Reference Number: EMA/CHMP/275518/2022 Rev. 1*

Document history

Liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/559889/2021 Legal effective date: 01/07/2023

Draft liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 17/12/2021 to 31/03/2022 Reference Number: EMA/CHMP/559889/2021 Summary:

Comments should be provided using this template. The completed comments form should be sent to [e-mail].