新药Ⅳ期临床试验与药品上市后再评价的异同点以及存在的问题  

Similarities and differences of new drug phase Ⅳ clinical trials and post-marketing drug evaluation as well as existing problems

作　　者：单爱莲[1] 蒋玉凤[2] 

机构地区：[1]北京大学第一医院临床药理研究所,北京100034 [2]新疆自治区人民医院临床药学研究所,乌鲁木齐830001

出　　处：《中国临床药理学杂志》2014年第5期387-390,396,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：本文将新药Ⅳ期临床试验与药品上市后再评价的相关政策背景进行了追溯,对两者的异同点进行了比较,并对存在的问题进行了探讨;同时,对具"药品促销倾向"的临床验证试验的特点进行了阐述,期望通过比较三者的区别,为临床医师与药师等明确临床试验的研究目的与范围、为临床合理用药提供研究数据。With the retrospection of the background information of new drug phase 1V clinical trials and post -marketing drug evaluation, this paper compared their similarities and differences and explored the exist- ing problems. Meanwhile, it illustrated the characteristics of clinically verified trials having inclination to pharmaceutical promotion, anticipating helping clinicians and clinical pharmacists clarify the purpose and range of clinical trials, and providing data for clinical rational drug use by dis- tinguishing evaluation promotion. among new drug phase IV clinical trial, post - marketing drug and clinical trials having inclination to pharmaceutical

关 键 词：药品上市后再评价 新药Ⅳ期临床试验 具“药品促销倾向”的临床验证试验 新药审批办法 药品注册管理办法 

分 类 号：R969.4[医药卫生—药理学] R954[医药卫生—药学]