Development of block-copolymer-micelle medicinal products - Scientific guideline
This 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.
Keywords: Block copolymer micelles, nanomedicines, non-clinical, first-in-human studies, drug development
Draft joint Ministry of Health, Labour and Welfare / European Medicines Agency reflection paper on the development of block-copolymer-micelle medicinal products (PDF/406.3 KB)Draft: consultation closed
First published: 01/02/2013
Last updated: 01/02/2013
Consultation dates: 01/02/2013 to 01/07/2013