| 药物临床试验中试验药物管理存在的问题与对策 |
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| 引用本文： | 沈玉红,张正付,李正奇. 药物临床试验中试验药物管理存在的问题与对策[J]. 中国药房, 2011, 0(22): 2093-2094 |
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| 作者姓名： | 沈玉红 张正付 李正奇 |
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| 作者单位： | 国家食品药品监督管理局药品认证管理中心; |
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| 摘 要： | 目的:为药物临床试验机构和监管部门对试验药品的管理和监管提供参考。方法:针对目前药物临床试验中试验药物管理存在的各种问题,进行归纳,并提出应对措施。结果与结论:试验药物管理的诸多问题存在于临床试验中的各个环节,各机构应建立并逐步完善严格规范的药物管理制度,积极借鉴信息化管理等新技术和方法,加强GCP培训。
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| 关 键 词： | 临床试验 药品管理 问题 对策 |
Problems and Solutions for the Drug Management in Drug Clinical Trials |
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| SHEN Yu-hong,ZHANG Zheng-fu,LI Zheng-qi. Problems and Solutions for the Drug Management in Drug Clinical Trials[J]. China Pharmacy, 2011, 0(22): 2093-2094 |
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| Authors: | SHEN Yu-hong ZHANG Zheng-fu LI Zheng-qi |
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| Affiliation: | SHEN Yu-hong,ZHANG Zheng-fu,LI Zheng-qi(Center for Drug Certification,State Food and Drug Administration,Beijing 100061,China) |
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| Abstract: | OBJECTIVE: To provide reference for drug management and monitoring in drug clinical trial institutions and monitoring authorities. METHODS: Various problems faced by authorities and institutions were summarized to put forward regulatory measures. RESULTS&CONCLUSIONS: There are many problems of drug management in clinical trails. The strict and standardized management system should be established in every institution, especially the new control skills such as IT, and GCP training should be strengthened. |
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| Keywords: | Clinical trials Drug management Problems Solutions |
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