IR@PKUHSC  > 北京大学第一临床医学院  > 临床药理研究所
学科主题药理学
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
其他题名Similarities and differences of new drug phase Ⅳ clinical trials and post -marketing drug evaluation as well as existing problems
单爱莲1; 蒋玉凤1
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 Post-marketing Drug Evaluation New Drug Phase Ⅳclini-cal Trial Clinically Verified Trials Having Inclination To Pharmaceutical Promotion Regulations For New Drug Approval Regulations For Registration And Management Of New Drug
刊名中国临床药理学杂志
2014
DOI10.3969/j.issn.1001-6821.2014.05.001
5页:387-390,396
收录类别中国科技核心期刊 ; 中文核心期刊 ; CSCD
文章类型Journal Article
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 Ⅳ 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 among new drug phase IV clinical trial , post-marketing drug evaluation and clinical trials having inclination to pharmaceutical promotion.
语种中文
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文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/44261
Collection北京大学第一临床医学院_临床药理研究所
作者单位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
Recommended Citation
GB/T 7714
单爱莲,蒋玉凤. 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[J]. 中国临床药理学杂志,2014(5):387-390,396.
APA 单爱莲,&蒋玉凤.(2014).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.中国临床药理学杂志(5),387-390,396.
MLA 单爱莲,et al."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".中国临床药理学杂志 .5(2014):387-390,396.
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