| 药师在管理药物临床试验安全性事件中的作用与意义 |
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| 引用本文： | 刘文辉,易湛苗,赵荣生,李晓光,唐惠林. 药师在管理药物临床试验安全性事件中的作用与意义[J]. 药品评价, 2011, 8(16): 16-19 |
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| 作者姓名： | 刘文辉 易湛苗 赵荣生 李晓光 唐惠林 |
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| 作者单位： | 1. 北京大学第三医院药剂科,北京,100191;北京大学药学院,北京,100083
2. 北京大学第三医院药剂科,北京,100191 |
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| 基金项目： | 国际标准化药物临床试验研完技术平台建设（心血管疾病及神经退行性疾病）,项目编号：新药临床评价研究技术平台2008ZX09312-015. |
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| 摘 要： | 为了发挥药师在药物临床试验中的作用,更好地管理临床试验相关的药物安全性事件,本文从安全性事件的定义、不良事件与研究药物的相关性判断、安全性事件的积极预防和处理、药师对临床试验相关药物安全性事件管理的意义及展望等六个方面,就药师在参与临床试验方案的设计、对临床试验中安全性事件的预警,阳性对照药品的选择和采购、试验用药品的运输、存储和分发以及正确使用的作用进行了阐述.
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| 关 键 词： | 药师 药物临床试验 安全性事件 |
Pharmacists in Managing the Safety Issues in Clinical Trials: Role and Significance |
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| LIU Wen-hui,YI Zhan-miao,ZHAO Rong-sheng,LI Xiao-guang,TANG Hui-ling. Pharmacists in Managing the Safety Issues in Clinical Trials: Role and Significance[J]. Drug Evaluation, 2011, 8(16): 16-19 |
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| Authors: | LIU Wen-hui YI Zhan-miao ZHAO Rong-sheng LI Xiao-guang TANG Hui-ling |
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| Affiliation: | 1. Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China; 2. College of Pharmacy, Perking University, Beijing 10083, China |
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| Abstract: | Pharmacists could play an important role in clinical trials and sate medicine use. In this article, the definition of safety issues, how to judge the correlation between adverse event （AE） and investigated products, prevention and handling of the safety issues, the significance of managing safety issues by pharmacists and perspectives of what we can do next were discussed. Pharmacists can contribute to protocol design, positive control medicine selection, and investigational products purchase, shipment, storage and distribution. |
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| Keywords: | Pharmacist Clinical trial Safety issues |
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