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

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Document details

Download document Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance
Reference number EMA/CHMP/800775/2017
Status draft: consultation open
First published 2018-06-26
Last updated 2018-07-05
Consultation start date 2018-07-05
Consultation end date 2018-09-30
Email address for submissions pkwpsecretariat@ema.europa.eu

Summary

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