1Bates DW, Cullen D J, Laird N. et al. Incidence of adverse drug events and potential adverse drug events: implications for prevention. ADE Prevention Study Group [ J ]. JAMA, 1995,274 : 29-34.
2ICH Guideline. E2D: Post-approval Safety Data Management: Definitions and Standards for Expedited Reporting.见:药品注册的国际技术要求-2007临床部分[M].北京:人民卫生出版社,2007.526-545.
