| 我院临床试验用药品的管理 |
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| 引用本文： | 吴娟,张顺国,陈敏玲.我院临床试验用药品的管理[J].实用药物与临床,2014(5):658-660. |
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| 作者姓名： | 吴娟 张顺国 陈敏玲 |
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| 作者单位： | 上海交通大学医学院附属上海儿童医学中心药剂科,上海200127 |
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| 摘 要： | 目的介绍我院临床试验用药品的管理方法,探讨合理的管理模式。方法从建立试验药品管理制度、建立中心试验药房管理模式、试验用药品管理的标准操作规程和质量控制等方面,阐述我院临床试验用药品的管理。结果从我院实践情况来看,中心试验药房管理模式在对试验用药品的管理上具有显著的优势。结论中心试验药房专人、专职、集中管理试验用药品,保障受试者用药安全,保证药物临床试验结果科学、可靠。
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| 关 键 词： | 临床试验用药品 管理 中心试验药房 |
Management of clinical trial drugs in our institution |
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| WU Juan,ZHANG Shun-guo,CHEN Min-ling.Management of clinical trial drugs in our institution[J].Practical Pharmacy and Clinical Remedies,2014(5):658-660. |
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| Authors: | WU Juan ZHANG Shun-guo CHEN Min-ling |
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| Institution: | ( Department of Pharmacy, Shanghai Children＇s Medical Center, School of Medicine, Shanghai Jiaotong Uni- versity, Shanghai 200127, China) |
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| Abstract: | Objective To introduce management of clinical trial drugs in our institution,and to discuss a rational management model. Methods Management of clinical trial drugs is stated in establishment of regulatory regime and centre trial pharmacy,SOP of drugs management,and quality control. Results In the practice of our hospital,it is remarkably superior for model of centre trial pharmacy about management of trial drugs. Conclusion Centre trial pharmacy model can safeguard the safety of all trial subjects,and ensure the scientificity and reliability of trial results. |
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| Keywords: | Clinical trial drugs Management Centre trial pharmacy |
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