中国药物流行病学研究方法学指南(T/CPHARMA 002-2019)

2019-06-20 中国药学会 中国药学会

药物流行病学是指采用流行病学的研究方法研究药物在人群中的使用情况和使用效果。药物流行病学研究能够为医疗产品的安全性和有效性提供有益的信息,并被越来越多地应用于卫生保健系统、干预措施及健康相关行为的评价

中文标题:

中国药物流行病学研究方法学指南(T/CPHARMA 002-2019)

英文标题:

Guide on methodological standards in pharmacoepidemiology (T/CPHARMA 002-2019)

发布机构:

中国药学会

发布日期:

2019-06-20

简要介绍:

药物流行病学是指采用流行病学的研究方法研究药物在人群中的使用情况和使用效果。药物流行病学研究能够为医疗产品的安全性和有效性提供有益的信息,并被越来越多地应用于卫生保健系统、干预措施及健康相关行为的评价中。为了保证药物流行病学的研究质量,激励有益于患者和公众医疗健康的创新,世界各国管理机构和学会组织分别基于本国国情颁布了相关的药物流行病学研究指南。而在我国,药物流行病学还处于起步阶段,尚无符合我国实际情况的药物流行病学研究指南等规范性文件,所以制定药物流行病学研究方法学指南对于我国药物流行病学的发展具有巨大的作用和意义。

为进一步促进药物流行病学研究的规范化,满足当前研究实践的需要,激励有益于患者和公众医疗健康的创新,中国药学会药物流行病学专业委员会在系统综述国内外药物流行病学研究方法学标准或指南的基础上,结合我国的医疗卫生实践,参考欧洲药品管理局药物流行病学研究方案清单(ENCePP Checklist for Study Protocols)制定出符合我国国情的药物流行病学研究方法学指南。

本标准可以为政府监管部门、研究机构、药物生产企业等开展药物流行病学研究提供指引和参考。

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    2021-07-26 景丞2

    0

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    2021-06-23 ms1000000091199067

    0

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    2021-06-22 122010f7m05暂无昵称

    刚才评论没得分再试试

    0

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    2021-06-21 ms8000001817907749

    0

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    2021-06-21 上工之术

    好文章,谢谢

    0