Marketing authorisation of orphan medicines in Europe from 2000 to 2013.

Matthias P Hofer, Hanna Hedman,Maria Mavris,Franz Koenig,Thorsten Vetter,Martin Posch,Spiros Vamvakas,Jan Regnstrom,Stiina Aarum

Drug Discovery Today（2018）

引用 28|浏览11

暂无评分

摘要

•Analysis on 157 orphan designated medicines at EU marketing authorisation (MA).•Company size is a determinant for MA success.•Compliance with scientific advice is a determinant for MA success.•Scientific advice is a tool to optimise development towards MA success

查看译文

关键词

company size,drug development,marketing authorisation,orphan medicines,protocol assistance,scientific advice

AI 理解论文

溯源树

样例

生成溯源树，研究论文发展脉络

Chat Paper

正在生成论文摘要