Liposomal amphotericin B product-specific bioequivalence guidance
Table of contents
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
- 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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Liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance (PDF/157.01 KB)
Adopted
First published: 16/12/2022
Legal effective date: 01/07/2023
EMA/CHMP/559889/2021 -
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Overview of comments received on 'Liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance’ (EMA/CHMP/559889/2021) (PDF/505.92 KB)
First published: 22/05/2023
EMA/CHMP/275518/2022
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List item
Liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance (PDF/157.01 KB)
Adopted
First published: 16/12/2022
Legal effective date: 01/07/2023
EMA/CHMP/559889/2021 -
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Draft liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance (PDF/145.1 KB)
Draft: consultation closed
First published: 17/12/2021
Consultation dates: 17/12/2021 to 31/03/2022
EMA/CHMP/559889/2021