ZHANG Yuan, YE Xiao-fei, ZHANG Tian-yi, ZHU Tian-tian, SHI Wen-tao, HE Jia. Foreign Pharmaceautical Enterprises' Pharmacovigilance Databases Overview and Enlightenments[J]. Chinese Journal of Pharmacovigilance, 2015, 12(10): 590-592.
[1] FDA. Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment[EB/OL].(2005-03-22)[2015-05-12].www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf. [2] Pfizer Ltd.Safety of medicines[EB/OL].(2015-03-01)[2015-05-12].http://www.pfizer.co.uk/content/safety-medicines. [3] Head Office and Registered Office,GlaxoSmithKline plc.GSK Annual Report 2014 [EB/OL].(2015-05-15)[2015-08-02].http://www.gsk.com/media/603031/annual-report-2014.pdf. [4] Hammond I W, Gibbs T G, Seifert H A, et al. Database size and power to detect safety signals in pharmacovigilance[J]. Expert opinion on drug safety, 2007, 6(6): 713-721. [5] Van Holle L, Bauchau V. Signal detection on spontaneous reports of adverse events following immunisation: a comparison of the performance of a disproportionality-based algorithm and a time-to-onset-based algorithm[J]. Pharmacoepidemiology and Drug Safety, 2014, 23(2): 178-185. [6] Candore G, Juhlin K, Manlik K, et al. Comparison of Statistical Signal Detection Methods Within and Across Spontaneous Reporting Databases[J]. Drug Safety, 2015,38(6):577-587. [7] ARISGLOBAL. ARISgTM. The Drug Safety Software Most Used by Pharmaceutical Companies[EB/OL].(2015-03-15)[2015-05-12].http://arisglobal.com/total-safety/arisg/. [8] SAYERS J. Implementing a quality management system in a global pharmacovigilance processing centre[J]. The Quality Assurance Journal, 2001, 5(2): 71-75. [9] Camberidge Healthtech. 2010 Best Practices Competition Basic Research and Drug Discovery[EB/OL].(2010-06-15).[2015-05-12]. www.chicorporate.com/uploadedfiles/bio-it_world/best_practices/2010/rnd-comp.pdf. [10] 石琴, 魏晶. 简述外资制药企业在中国建立药品不良反应监测系统[J]. 中国医药指南,2015,5(13): 286-287. [11] 张建华, 王清理, 孔蕊. 影响药物不良反应监测的因素探讨[J]. 中国现代药物应用, 2012,6(13): 75-76.