Pegylated liposomal doxorubicin hydrochloride product-specific bioequivalence guidance

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
• 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

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/800775/2017 Legal effective date: 01/07/2019

Document history

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/800775/2017 Legal effective date: 01/07/2019

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Reference Number: EMA/CHMP/681372/2018

Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 05/07/2018 to 30/09/2018 Reference Number: EMA/CHMP/800775/2017 Summary:

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.