Document details
| Download document | Draft joint Ministry of Health, Labour and Welfare / European Medicines Agency reflection paper on the development of block-copolymer-micelle medicinal products |
|---|---|
| Reference number | EMA/CHMP/13099/2013 |
| Status | draft: consultation open |
| First published | 01/02/2013 |
| Last updated | 01/02/2013 |
| Consultation start date | 01/02/2013 |
| Consultation end date | 01/07/2013 |
| Email address for submissions | nanomedicines@ema.europa.eu |
Summary
This paper provides basic information for the pharmaceutical development, and non-clinical and early clinical studies of block-copolymer-micelle drug products created to affect the pharmacokinetics, stability and distribution of incorporated or conjugated active substances in vivo.