Pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants) - Scientific guideline
Table of contents
This 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.
Keywords: Solubilisation, surfactant, micelle, critical micelle concentration (c.m.c.), intravenous
-
List item
Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (PDF/138.3 KB)
Adopted
First published: 20/03/2012
Last updated: 20/03/2012
Legal effective date: 20/03/2012
EMA/CHMP/QWP/799402/2011 -
List item
Overview of comments received on ' Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants) ' (EMA/CHMP... (PDF/241.1 KB)
First published: 20/03/2012
Last updated: 20/03/2012
EMA/CHMP/QWP/686808/2011 -
List item
Draft reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants) (PDF/164.06 KB)
Draft: consultation closed
First published: 13/10/2010
Last updated: 13/10/2010
Consultation dates: 23/09/2010 to 31/12/2010
EMA/CHMP/QWP/574767/2010