我国药品上市后再评价的概念辨析与类型介绍  

Concepts and types of re-evaluation of post-marketing drugs in China

作　　者：何伟[1] 

机构地区：[1]陕西中医药大学基础医学院,陕西咸阳712046

出　　处：《中南药学》2015年第7期780-782,共3页Central South Pharmacy

摘　　要：药品上市后再评价是药品生命周期中的重要研究阶段,目前我国药品上市后再评价存在概念混淆不清,对相关法规及指导原则动态不甚了解,研究设计选择与实施不当等情况,说明我国药品上市后再评价的开展及推广仍有较大空间。本文通过辨析药品上市后再评价相关概念的关系,掌握药品上市后再评价研究发展动态,探索适宜药品上市后再评价的设计类型,分析目前药品上市后再评价采用的关键技术,以期加深临床评价工作者对药品上市后再评价的认识。Post-marketing drug re-evaluation is an important post-marketing drug re-evaluation concepts are confusing, the stage of the life cycle of drugs in China. The current estimators do not quite understand the related regula- tions and dynamic guidelines, and choices of clinical trial design and implementations are improper, which all indi- cate that the post-marketing drug re-evaluation in China has much room for improvement. Through analyzing post- marketing re-evaluation related concepts, we grasped the post-marketing drug re-evaluation development, explored the suitable design of post-marketing drug re-evaluation, analyzed the key technologies on the current post-marketing drug re-evaluation, and hope to reinforce the clinical estimators＇ understanding of post marketing drug re-evaluation.

关 键 词：药品上市后再评价 Ⅳ期临床试验 关键技术 试验设计 

分 类 号：R951[医药卫生—药学]