Pegylated liposomal doxorubicin hydrochloride product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.
Keywords: Bioequivalence, generics, pegylated liposomal doxorubicin hydrochloride
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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Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance (PDF/82.91 KB)
Adopted
First published: 13/12/2018
Legal effective date: 01/07/2019
EMA/CHMP/800775/2017 -
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Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017) (PDF/564 KB)
First published: 13/12/2018
EMA/CHMP/681372/2018 -
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Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance (PDF/83.84 KB)
Draft: consultation closed
First published: 26/06/2018
Last updated: 05/07/2018
Consultation dates: 05/07/2018 to 30/09/2018
EMA/CHMP/800775/2017