| 中药Ⅰ期临床耐受性试验的设计与实施 |
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| 引用本文： | 张锡玮.中药Ⅰ期临床耐受性试验的设计与实施[J].辽宁中医学院学报,2013(8):24-26. |
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| 作者姓名： | 张锡玮 |
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| 作者单位： | 辽宁中医药大学附属医院,辽宁沈阳110032 |
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| 摘 要： | 针对Ⅰ期临床耐受性试验的现状,从现行法规和技术要求,并结合工作经验,重点论述了中药Ⅰ期临床试验设计与实施中应注意的问题,尤其是在试验时需要把握的质量控制要点,如知情同意书设计、试验实施过程的质控等。
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| 关 键 词： | 中药 Ⅰ期临床 设计 实施 |
Design and Implementation of Chinese Medicine Phase I Clinical Tolerance Test |
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| ZHANG Xiwei.Design and Implementation of Chinese Medicine Phase I Clinical Tolerance Test[J].Journal of Liaoning College of Traditional Chinese Medicine,2013(8):24-26. |
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| Authors: | ZHANG Xiwei |
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| Affiliation: | ZHANG Xiwei ( Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, Liaoning, China ) |
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| Abstract: | According to the situation of the phase I clinical tolerance test, from the current regulations and technology, combined with the work experience, the paper focuses that the design and the implementation should pay attention to clinical trials of traditional Chinese medicine in stage I in question, especially the quality control points in the test needs, such as informed consent design, test implementation process quality control. |
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| Keywords: | traditional Chinese medicine phase I clinical design implementation |
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