| 卫星药房建设提升临床试验质量 |
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| 引用本文： | 董晶王雅琼朱娜周学锋.卫星药房建设提升临床试验质量[J].中国卫生质量管理,2022,0(9):072-75. |
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| 作者姓名： | 董晶王雅琼朱娜周学锋 |
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| 作者单位： | 青岛市中心医院 |
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| 摘 要： | 试验用药品规范化管理有助于提升临床药物研究水平。从硬件设施、人员配备及资质、文件管理、质量控制等方面建设卫星药房，并采取GCP药房监管模式，实现试验用药品闭环管理。实施后，试验用药品质控问题减少，管理更加规范。卫星药房可作为GCP 药房的补充，确保试验用药品安全，提升临床试验质量。
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| 关 键 词： | 药物临床试验 卫星药房 试验用药品 质量控制 |
Construction of Satellite Pharmacy for Promotion of the Quality of Clinical Trial |
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| DONG Jing,WANG Yaqiong,ZHU Na.Construction of Satellite Pharmacy for Promotion of the Quality of Clinical Trial[J].Chinese Health Quality Management,2022,0(9):072-75. |
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| Authors: | DONG Jing WANG Yaqiong ZHU Na |
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| Affiliation: | Qingdao Central Hospital |
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| Abstract: | Standardized management of trial drugs contributes to improving the level of pharmaceutical clinical research. Satellite pharmacy was constructed from hardware facilities, personnel, qualification, document management, quality control and other aspects, and GCP pharmacy supervision mode was adopted to realize closed-loop management of trial drugs. After implementation, the frequency of quality control problems of trial drugs decreased and management became more standardized. Satellite pharmacy can be used as a supplement to GCP pharmacy, ensuring the safety of trial drugs and improving the quality of clinical trials. |
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| Keywords: | Pharmaceutical Clinical Trial Satellite Pharmacy Trial Drugs Quality Control |
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