罕用药新品种开发及临床评价  

Development and clinical evaluation of orphan drugs

作　　者：袁芳[1] 沈舜义[1] 

机构地区：[1]上海医药工业研究院生物部,上海200040

出　　处：《世界临床药物》2011年第5期307-311,共5页World Clinical Drug

摘　　要：我国罕用药的研发近年逐步引起关注,目前我国对于罕见病的研究以及罕用药的开发主要参照国际发达国家的经验。本文简要回顾美国等发达国家鼓励罕用药开发的相关政策,重点介绍近期上市的几种罕用药新品种及其临床评价。The research and development of orphan drugs has been concerned gradually in recent years.The experience of developed countries in this field is a good reference to our country.This review describes the orphan drugs development policy in the United States and other developed countries,especially focuses on the recent listed orphan drugs and their clinical evaluation.

关 键 词：罕见病 罕用药 研发 

分 类 号：R98[医药卫生—药品]