| 我国抗菌药物说明书临床内容的撰写要求 |
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| 引用本文： | 谢松梅,杨进波,赵明,赵德恒,李娅杰. 我国抗菌药物说明书临床内容的撰写要求[J]. 中国临床药理学杂志, 2008, 24(6) |
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| 作者姓名： | 谢松梅 杨进波 赵明 赵德恒 李娅杰 |
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| 作者单位： | 国家食品药品监督管理局药品审评中心,北京,100038 |
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| 摘 要： | 目前,我国抗菌药物说明书在临床内容撰写方面存在的一些问题,影响了说明书对临床用药的指导性作用,因此,本文介绍了新修订的《抗菌药物临床试验技术指导原则》中有关说明书临床内容撰写的新要求,以期为该类药物说明书更科学合理的撰写提供参考。
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| 关 键 词： | 抗菌药物说明书 |
Requirements for clinical contents presentation of the package insert on antibacterial agents in China |
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| XIE Song-mei,YANG Jin-bo,ZHAO Ming,ZHAO De-heng,LI Ya-jie. Requirements for clinical contents presentation of the package insert on antibacterial agents in China[J]. The Chinese Journal of Clinical Pharmacology, 2008, 24(6) |
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| Authors: | XIE Song-mei YANG Jin-bo ZHAO Ming ZHAO De-heng LI Ya-jie |
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| Abstract: | Now,some issues about the presentation which influence the guidance role for clinical medication existed in the clinical contents of the package insert on antibacterial agents.So,this article introduce the new requirements about the this part of contents in the newly revised guide-lines for clinical research of antibacterial agents in order to make the re-lated presentation more scientific and more reasonable. |
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| Keywords: | antibacterial agents package insert |
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