Pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants)

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Reflection paper

Reference numberEMA/CHMP/QWP/799402/2011
Published20/03/2012
KeywordsSolubilisation, surfactant, micelle, critical micelle concentration (c.m.c.), intravenous
DescriptionThis document describes a basic data package that is relevant to confirm the sound pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems.  


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First version

Current version

Reflection paper


Overview of comments


Draft reflection paper

Published: 20/03/2012


Published: 20/03/2012


Published: 26/06/2011


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