Development of block-copolymer-micelle medicinal products

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Current effective version

Reflection paper

Reference numberEMA/CHMP/13099/2013
KeywordsBlock copolymer micelles, nanomedicines, non-clinical, first-in-human studies, drug development
DescriptionThis document provides basic information for the pharmaceutical development, and non-clinical and early clinical studies of block-copolymer micelle drug products created to affect pharmacokinetics, stability and distribution of incorporated or conjugated active substances in vivo. It is a joint reflection paper of the Ministry for Health, Labour and Welfare  and the European Medicines Agency.

Document history

First version

Current version

Reflection paper

Draft reflection paper

Published: 10/01/2014

Published: 01/02/2013

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