Differences Between Clinical Trials of Medical Devices and Drugs

被引：0

作者：

ZHANG Zhi-jun ^{[1
]}

LIU Wei ^{[1
]}

机构：

[1] Center of Medical Device Evaluation,China Food and Drug Administration

来源：

Chinese Journal of Biomedical Engineering | 2014年 / 23卷 / 03期

关键词：

medical devices; drugs; clinical trials; differences;

D O I：

暂无

中图分类号：

D922.16 [文教、卫生管理法令];

学科分类号：

030103 ;

摘要：

How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the two points from the perspectivs of definition of medical devices and drugs, scope, phasing, subjects and design of clinical trials in details, aiming to help the related personnel make scientific decisions while conducting clinical trial design for medical devices.

引用

页码：93 / 97

页数：5

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