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法国兽药警戒体系简介与启示 被引量:2

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摘要 1974年,法国科学家首次提出药物警戒(Pharmacovigilance,PV)的说法,当时主要强调对药物不良反应(Adverse Drug Reaction,ADR)的监测。2002年,世界卫生组织进一步完善了对PV的定义:PV是与发现、评价、理解和预防ADR或其他任何可能与药物有关问题的科学研究与活动[1]。可见,PV的理念是在ADR的基础上,
出处 《中国兽医杂志》 CAS 北大核心 2016年第3期124-126,共3页 Chinese Journal of Veterinary Medicine
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参考文献7

  • 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. 被引量:15
  • 2European Commission.Directive 2004/28/EC ofthe European Parliament and of the Council[EB/OL].http://ec.europa.eu/health/files/eudralex/vol-5/dir_2004_28/dir_2004_28_en.pdf.
  • 3European Commission.Volume 9B-Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use[EB/OL].http://ec.europa.eu/health/files/eudralex/vol-9/vol_9b_2011-10.pdf.
  • 4EMA.List of changes to combined Ve DDRAlist of clinical terms[EB/OL].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/12/WC500017727.pdf.
  • 5中华人民共和国国务院令第404号.兽药管理条例[Z]. 2004.
  • 6农业部令第44号.兽药注册管理办法[Z].2004.
  • 7农业部公告第1899号[EB/OL].http://www.moa.gov.cn/zwllm/tzgg/gg/201302/t20130220_3222165.htm.

二级参考文献26

  • 1Tsintis P, La Mache E. CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications[J]. Drug Saf,2004,27(8) :509-517.
  • 2Cobert BL. Manual of Drug Safety and Pharmacovigitance [ M ]. 2nd ed. Jones and Bartlett Publishers, 2007.
  • 3Waller PC, Evans SJ. A model for the future conduct of pharmacovigilance [ J ]. Pharmacoepidemiol Drug Saf, 2003, 12(1) :17-29.
  • 4FDA. Challenges and Opportunities Report [ EB/OL]. http ://www. fda. gov/ScienceResearch/SpecialTopics/ Critical-Pathlnitiative/ CriticalPathOpportunitiesReports/ ucm077 262. htm , 2004/2010-06-02.
  • 5Di Masi JA, Hansen RW, Grabowski HG, et al. The price of innovation : new estimates of drug development costs [ J ]. J Health Econ ,2003,22 : 151-185.
  • 6Mann RD, Andrews EB. Pharmacovigilance [ M ]. 2nd ed. New Jersey: John Wiley & Sons, Ltd. , 2007.
  • 7Leiderman DB. Risk management of drug products and the U.S. Food and Drug Administration: evolution and context [ J ]. Drug Alcohol Depend,2009,105 ( Suppl 1 ) : S9-S13.
  • 8EMA. Guideline on Risk Management Systems for Medical Products for Human Use [ EB/OL ]. http ://www. ema. europa. eu/pdfs/human/euleg/9626805en, pdf, 2005/2010-06- 02.
  • 9ICH E2E. Pharmacovigilance Planning [ EB/OL ]. http :// www. ich. org/cache/compo/475 - 272 - 1. html # E2E, 2004/2010-06-02.
  • 10FDA Guidance for Industry: Premarketing Risk Assessment [ EB/OL]. http ://www. fda. gov/downloads/Regulatorylnformation/ Guidanees/ uem12695 8. pdf , 2005/2010-06-02.

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