参考文献(References)
[1]ICH Guideline.E2A:Clinical safety data management:definitions and standards for expedited reporting.(1994-10-27)[2019-12-20].https://database.ich.org/sites/default/files/E2A_Guideline.pdf.
[2]ICH Guideline.E2D:Post-approval safety data management:definitions and standards for expedited reporting.(2003-11-12)[2019-12-20].https://database.ich.org/sites/default/files/E2D_Guideline.pdf.
[3]European Commission.Volume 9A of the rules governing medicinal products in the European Union-guidelines on pharmacovigilance for medicinal products for human use.(2011-10-02)[2019-8-20].http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en/pdf.
[4]FDA.FDA Code of Federal Regulations,title 21:314.80 Postmarketing reporting of adverse drug experiences.(2019-09-19)[2019-8-20].https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.
[5]U.S.Department of Health and Human Services.FDA MedWatch 3500A form(For use by user-facilities,importers,distributors and manufacturers for MANDATORY reporting).(2008-10-31)[2020-8-27].https://www.fda.gov/media/69876/download.
[6]MedDRA MSSO/IFPMA.MedDRA Term Selection:Points to Consider Release 4.19 Based on MedDRA Version 23.0.(2020-03-01)[2020-08-27].https://admin.new.meddra.org/sites/default/files/guidance/file/000401_termselptc_r4_19_mar2020.pdf.
[7]MedDRA MSSO/IFPMA.MedDRA Data Retrieval and Presentation:Points to Consider release 3.19 Based on MedDRA Version 23.0.(2020-03-01)[2020-08-27].https://admin.new.meddra.org/sites/default/files/guidance/file/000402_datretptc_r3_19_mar2020.pdf.
[8]European Commission.Communication from the Commission-Detailed guidance on the collection,verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use(‘CT-3').(2011-11-06)[2020-9-17].https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52011XC0611(01).
[9]HILL A B.The environment and disease:association or causation? J Roy Soc Med,1965(58):295-300.
[10]HOWICK J,GLASZIOU P,ARONSON J.The evolution of evidence hierarchies:what can Bradford Hill's guidelines for causation contribute? J R Soc Med,2009(102):186-194.
[11]WHO.WHO Uppsala Monitoring Center standadised case causality assessment.(2018-04-06)[2020-08-26].http://who-umc.org/Graphics/24734.pdf.
[12]CIOMS Working GroupⅥ on the Management of Safety Information from Clinical Trials,Council for International Organizations of Medical Sciences.Management of safety information from clinical trials:report of CIOMS Working Group Ⅵ.New York:Renouf Pub Co Ltd,2005.
[13]KARCH F E,LASAGNA L.Toward the operational identification of adverse drug reactions.Clin Pharmacol Ther,1977,21(3):247-254.
[14]KRAMER M S,LEVENTHAL J M,HUTCHINGSON T A,et al.An algorithm for the operational assessment of adverse drug reactions.I.Background,description and instructions for use.JAMA,1979(242):623-632.
[15]VENULET J,CIUCCI A,BERNEKER G C.Standardized assessment of drug-adverse reaction associations-rationale and experience.Int J Clin Pharmacol ther Toxicol,1980(18):381-388.
[16]VENULET J,CIUCCI A,BERNEKER G C.Updating of a method for causality assessment of adverse drug reactions.Int J Clin Pharmacol ther Toxicol,1986(24):559-568.
[17]NARANJO C A,BUSTO U,SELLERS E M,et al.A method for estimating the probability of adverse drug reactions.Clin Pharmacol Ther,1981(30):239-245.
[18]BEGAUD B,EVREUX J C,JOUGLARD J,et al.French imputability method.Therapie,1985(40):111-118.
[19]JONES J K.Adverse drug reactions in the community health setting:approaches to recognizing,counseling,and reporting.Fam Community Health,1982(5):58-67.
[20]U.S.Department of Health and Human Services,FDA,Center for Drug Evaluation and Research(CDER),et al.Guidance for industry drug-induced liver injury:premarketing clinical evaluation.(2007-10-12)[2020-8-1].https://evs.nci.nih.gov/ftp1/CTCAE/Related/UCM072278.pdf.
[21]European Medicines Agency and Heads of Medicines Agencies.Guidelines on good pharmacovigilance practices(GVP)Module Ⅵ-Management and reporting of adverse reactions to medicinal products.(2013-06-06)[2020-9-17].https://www.onacademic.com/detail/journal_1000032564780010_b747.html.
[22]FDA.MedWatch3500 form(For VOLUNTARY reporting of adverse events,product problems and product use errors).(2019-02-09)[2020-8-1].http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/ucm082728.pdf.