1Expedite d Safety Reporting Requirements For Human Drug and Biological Products[R].Docket No.93N-0181.1997,62(194):522-537.
2Brown Kristina,Sykes Scotts,Phillips George.That Adverse Experience Really Expected? Guidelines For Interpreting And Formatting Adverse Experience Information in the United States[J].Drug Information Journal,2001,35:269-284.
3Guidance For Industry:Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products-Content And Format.U.S.Department of Food and Drug Administration,Center for Drug Evaluation and Research,Center for Biologics Evaluation and Research[R].Labeling,2006-412.
4Pragmatic Approaches-Report of CIOMS Working Group Ⅴ[R].Current Challenges in Pharmacovigilance.Geneva,2001.