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


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