| 提高我国药物临床试验质量的初步思考与几点建议 |
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| 引用本文： | 闫永波,李野. 提高我国药物临床试验质量的初步思考与几点建议[J]. 中国新药杂志, 2012, 0(6): 584-586 |
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| 作者姓名： | 闫永波 李野 |
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| 作者单位： | 沈阳药科大学工商管理学院;辽宁本溪市中心医院 |
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| 摘 要： | 通过对我国药物临床试验质量管理的现状进行分析,提出存在的问题和相应的对策。通过加强监管、实行"三级质控"的管理模式和调动监察员的积极性来提高我国药物临床研究的质量。
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| 关 键 词： | 临床试验 质量管理 三级质控 |
How to improve the quality of clinical trials in China |
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| YAN Yong-bo,LI Ye. How to improve the quality of clinical trials in China[J]. Chinese Journal of New Drugs, 2012, 0(6): 584-586 |
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| Authors: | YAN Yong-bo LI Ye |
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| Affiliation: | 1(1 School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China; 2 Benxi Central Hospital of Liaoning Province,Benxi 117000,China) |
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| Abstract: | From the current situations of quality administration of drug clinical trails in China,we analyzed the existing problems and suggested corresponding countermeasures.The supervision should be strengthened,the "tertiary quality control" management should be carried out and the enthusiasm of our inspectors should be mobilized.These may improve the quality of drug clinical trials. |
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| Keywords: | clinical trials quality administration tertiary quality control |
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