Development of block-copolymer-micelle medicinal products

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Reflection paper

Reference numberEMA/CHMP/13099/2013
Published10/01/2014
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.


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First version

Current version

Reflection paper


Draft reflection paper

Published: 10/01/2014


Published: 01/02/2013


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