参考文献

［1］孙钰.药物警戒的起源、发展与展望［J］.药物流行病学杂志，2010，19（8）：454-461.

［2］World Health Organization.Pharmacovigilance：ensuring the safe use of medicines［R/OL］.（2004）［2019-7-28］.https：//apps.whoi.nt/medicinedocs/en/d/Js6164e/7.html.

［3］国家食品药品监督管理总局.药品不良反应报告和监测管理办法［R/OL］.（2011年卫生部令第81号）［2019-12-28］.http：//www.nmpa.gov.cn/WS04/CL2174/300642.html.

［4］Almenoff J，Tonning JM，Lawrence Gould A，et al.Perspectives on the use of data mining in Pharmacovigilance［J］.Drug Safety，2005，28（11）：981-1007.

［5］European Medicines Agency.Guideline on good pharmacovigilance practices（GVP）［R/OL］.（2004）［2019-12-22］.https：//www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/goodpharmacovigilance-practices.

［6］European Medicines Agency.Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies［R/OL］.（2012-9-26）［2019-12-22］.https：//www.ema.europa.eu/en/documents/other/guidance-format-content-protocol-non-interventional-post-authorisation-safety-studies＿en.pdf.

［7］FDA.Guidance for industry：drug-induced liver injury，premarketing clinical evaluation［R/OL］.（2009）［2019-7-28］.https：//www.fda.gov/media/116737/download.

［8］Tansel A，Kanwal F，Hollinger FB.Use of Hy’s Law，R criteria，and nR criteria to predict acute liver failure or transplantation in patients with drug-induced liver injury［J］.Gastroenterology，2015，148（2）：452.

［9］World Health Organization.The importance of pharmacovigilance：safety monitoring of medicinal products［R/OL］.（2002）［2019-7-28］.http：//apps.whoi.nt/medicinedocs/pdf/s4893e/s4893e.

［10］Zhou H，Zeng F，Tang J.Pharmacovigilance in China［M］.3rd ed.New York：Wiley，2014：263-265.