药品安全性病例报告表比较研究

魏晶;潘卫三;杨悦

中国药学杂志 ›› 2009, Vol. 44 ›› Issue (08) : 637-639.

中国药学杂志 ›› 2009, Vol. 44 ›› Issue (08) : 637-639.
药事管理

药品安全性病例报告表比较研究

  • 魏晶,;潘卫三;杨悦
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魏晶;潘卫三;杨悦. 药品安全性病例报告表比较研究[J]. 中国药学杂志, 2009, 44(08): 637-639

参考文献

[1] FDA. International Conference on Harmonization:Draft Guidance on E2B? Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports; Availability[J]. Fed Regist,2005,70(190):57610-57611. [2] CIOMS.CIOMS FORM [EB/OL] Switzerland:WHO,2003(2009-1-26)[2009-2-2],http://www.cioms.ch/cioms.pdf. [3] FDA. MedWatch Online Voluntary Reporting Form (3500) [EB/OL],USA:FDA,2003(2008-7-29)[2008-8-5,]https://www.accessdata.fda.gov/scripts/medwatch/ [4] Health Canada. CADRM[EB/OL].Canada:Health Canada,2002(2008-6-6)[2008-8-5],http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php [5] MHRA.Yellow card[EB/OL].UK:MHRA,2003(2008-2-15)[2008-8- 6],http://yellowcard.mhra.gov.uk/downloads/ [6] ADRAC.Blue Card[EB/OL],AUS:TGA,2005(2008-4-8)[2008-8- 10],http://www.tga.gov.au/adr/bluecard.pdf [7] ICH.E2D:Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting[J]. Fed Regist,2003,68(178):53983-53984.

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