| 各国疫苗Ⅳ期临床监管对我国的借鉴意义 |
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| 引用本文： | 钱小慧,王越,王高玲,史长军.各国疫苗Ⅳ期临床监管对我国的借鉴意义[J].辽宁中医学院学报,2013(5):224-226. |
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| 作者姓名： | 钱小慧 王越 王高玲 史长军 |
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| 作者单位： | [1]南京中医药大学经贸管理学院,江苏南京210046 [2]江苏省药监局泰州医药高新技术产业开发区直属分局,江苏泰州225300 [3]泰州市中国医药城疫苗工程中心,江苏泰州225300 |
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| 摘 要： | 目的：为我国疫苗Ⅳ期临床监管提供可行性建议。方法：利用文献搜集法,通过对美国、澳大利亚、日本、加拿大等具有疫苗Ⅳ期临床监管成功经验国家的特点进行分析总结,再结合我国疫苗监管实际情况,提出建议。结果与结论：国外Ⅳ期临床监管在数据库建设、专家队伍、信息反馈等方面具有强大优势,我国可学习借鉴。
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| 关 键 词： | Ⅳ期临床 免疫接种不良反应监测 特点 建议 |
Reference Significance of IV Period Clinical Supervision of Vaccine in Foreign Countries |
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| QIAN Xiaohui,WANG Yue,WANG Gaoling,SHI Changjun.Reference Significance of IV Period Clinical Supervision of Vaccine in Foreign Countries[J].Journal of Liaoning College of Traditional Chinese Medicine,2013(5):224-226. |
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| Authors: | QIAN Xiaohui WANG Yue WANG Gaoling SHI Changjun |
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| Institution: | 1.Institute of Economic and Management, Nanjing University of Chinese Medicine, Nanjing 210046, Jiangsu, China; 2.Jiangsu Provincial SFDA, China Medical City Branch, Taizhou 225300, Jiangsu, China.3.Vaccine Engineering Center of China Medical City, Taizhou 225300, Jiangsu, China ) |
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| Abstract: | Objective ： To provide feasible suggestions to the domestic IV phase clinical supervision of vaccine. Methods ： By literature researching, countries which have successful experience in IV phase clinical supervision of vaccine are analyzed and compared, such as United States, Australia, Japan, Canada and so on. Combined with Chinese actual situation, suggestions are proposed. Results ＆ Conclusions ： The IV phase clinical supervision of vaccine in foreign countries has advantages on aspects of database construction, experts team, information feedback, etc, and has significant value for reference. |
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| Keywords: | IV phase clinical AEFI character suggestion |
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