| 药物警戒汇总报告 |
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| 引用本文： | Tamara Mazza,Carrie E Corboy,西安杨森药品安全部.药物警戒汇总报告[J].中国药物警戒,2009,6(12):761-764. |
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| 作者姓名： | Tamara Mazza Carrie E Corboy 西安杨森药品安全部 |
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| 作者单位： | 1. 强生制药公司风险效益评价总部,美国 宾夕法尼亚州,霍舍姆 19044
2. 西安杨森制药有限公司,北京,100025 |
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| 摘 要： | 药物警戒汇总报告是许多国家医疗管理部门要求企业递交的一系列药物警戒文件，包括欧盟的年度安全报告（ASR）及美国的研究新药物年度报告为临床信息汇总报告（IND）。上市后汇总报告包括欧盟、人用药物注册技术国际协调会议（ICH）的定期安全性信息更新报告（PSUR）及美国的定期药物不良事件报告（PADER）。药物警戒汇总报告将继续发展并成为信号检测及评估的较好手段之一。
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| 关 键 词： | 汇总报告 年度安全报告 新药年度报告 安全信息更新报告 |
Pharmacovigilance Aggregate Reports |
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| Tamara Mazza,Carrie E Corboy,Xian-Janssen Pharmaceutical CO.,LTD..Pharmacovigilance Aggregate Reports[J].Chinese JOurnal of Pharmacovigilance,2009,6(12):761-764. |
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| Authors: | Tamara Mazza Carrie E Corboy Xian-Janssen Pharmaceutical CO LTD |
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| Institution: | Tamara Mazza, Carrie E Corboy, Xian-Janssen Pharmaceutical CO.,LTD.(Tanslation) (1Johnson and Johnson (Pennsylvania 19044, the United States of America) 2Xian-Janssen Pharmaceutical CO.,LTD.(Beijing 100025, China)) |
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| Abstract: | The term ＂Aggregate Report＂ refers to a number of pharmacovigilance documents that are required by many health authorities around the world. The clinical aggregate report in the EU is called the Annual Safety Report（ASR）. The clinical aggregate report in the US is called the Investigational New Drug（IND） Annual Report. There are two types of post-marketing aggregate reports required by health authorities around the world： the EU（and ICH） Periodic Safety Update Report（PSUR） and the US Periodic Adverse Drug Experience Report（PADER）. It is anticipated that the vision of aggregate reports will evolve as better methods of signal detection and evaluation emerge around the world. |
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| Keywords: | aggregate reports annual safety report（ASR） new drugannual report periodic safety update report（PSUR） |
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