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制药企业药品上市前安全风险管理 被引量：2

Pre-marketing Drug Safety Risk Management in the Pharmaceutical Industry
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摘要 1药物警戒的必要性良好的药物警戒是最理想的药品风险管理方式,它可以最大程度的了解某种药品的所有信息,并且发现它潜在的安全问题,甚至有可能发现其预料之外的好处。鉴于这个理念,新化学实体（newchemical entity）在研发初期就必须进行动物和人体安全性测试,以便更好地促进并保护公众健康。中国古话所说的＂是药三分毒＂,
作者 Judith K Jones Elyse E Kingery Jing Tao Jeff J Guo
机构地区 美国弗吉尼亚州Degge集团公司 美国辛辛那提大学医学中心 美国辛辛那提大学药学院药物实践及管理科学部
出处 《药物流行病学杂志》 CAS 2013年第5期266-273,共8页 Chinese Journal of Pharmacoepidemiology
关键词 上市前 安全风险管理 药物警戒 安全性 有效性 安全评估
分类号 R951 [医药卫生—药学]
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参考文献18

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  • 2Cosyns JP. Aristolochic acid and Chinese herbs nephropathy: a review of the evidence to date[J]. Drug Saf,2003,26( 1 ) : 3348.
  • 3De Broe ME. Chinese herbs nephropathy and Balkan endemic nephropathy: toward a single entity, aristolochic acid ne- phropathy [ J]. Kidney Int,2012,81 (6) :513-515.
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  • 5Jones JK, Kingery EE. History of Pharmacovigilanee [ A ]. In : Mann , Andrews. Pharmacovigilance [ M ]. 2nd ed. Chich- ester, UK:John Wiley &Sons. Ltd,2013 (In Press).
  • 6Myers S, Baron B, Radke-Mitchell L, et al. Preparing an in- tegrated summary of safety : a writer' s perspective [ J ]. Drug Information Journal, 1998,32:53-63.
  • 7Novartis Pharma. CLOZARIL? [ EB/OL] . http ://www. phar- ma. us. novartis, com/ product/ pi / pdf / Clozaril. pdf ,2013-04-02.
  • 8Alphs L, Anand R, Islam MZ, et al. The international sui- cide prevention trial (interSePT) : rationale and design of a trial comparing the relative ability of clozapine and olanzapine to reduce suicidal behavior in schizophrenia and schizoaffec- tire patients [ J ] . Schizophr Bull, 2004,30 ( 3 ) : 577-586.
  • 9International Conference on Harmonization of Technical Re- quirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guidelines[ EB/OL]. http:// uzww. ich. org/products/guidelines/safety/article/safety-guidelines, html ,2013-04-02.
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同被引文献29

  • 1杨雪冬.全球化、风险社会与复合治理[J].马克思主义与现实,2004,56(4):61-77. 被引量：287
  • 2ICH Harmonized Tripartite Guideline. Pharmacovigilance Planning E2E [ EB/OL ]. http://www, ich. org/fileadmin/ Public _ Web _ Site/ lCH _ Products/ Guidelines/ Efficacy/ E2E! Step4 / E2 E_Guideline. pdf ,2OOd- I 1-18/2014-03-11.
  • 3FDA Guidance tbr Industry. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment [ EB/OL ]. http:// www. f da. gov / downlouts / regulatoryitorrmttion/ guidances/ ucm 126834. pdf, 2005 -03/2014 -03 - 11.
  • 4FDA. FDA Guidance for Industry, Format and Content of Pro- posed Risk Evaluation and Mitigation Strategies (REMS). REMS Assessments, and Proposed REMS Modifications [ EB/ OL ]. http ://www. fda. gov/downlocMs/Drugs/Guidances/ UCM184128. pdf ,2009-09 /2014-03-11.
  • 5EMA. EMA Guideline on Good Pharmacwigilatwe Practices (GVP) Module V-Risk management systents [ EB/ OL ] . http :// www. ema. europa, eu/docs/en_GB/document_library/Scien- tific _ guideline/2012/06/WC500129134, pdf, 2012-06-22/2014-03-11.
  • 6FDA. FDA' s Sentinel Initiative [ EB/OL ]. http ://www. fda. gov/Safety/FDAsSentinellnitiative/uem149341, htm, 2014-03- 11.
  • 7FDA. Mini-Sentinel: FDA' s New Tool for Monitoring the Safety of FDA-approved Medical Products [ EB/OL]. http :// www. fda. gov/downloads/AboutFDA/Transparency/Basics/ UCM301401. pdf ,2014-03-11.
  • 8Platt R, Carnahan RM, Brown JS, et al. The US Food and Drug Administration' s Mini-Sentinel program: status and di- rection [ J]. Pharmacoepidemiology and Drug Safety,2012,21 (S1) :1-8.
  • 9Sixth Annual Sentinel Initiative Public Workshop [ EB/OL ]. http://www, brookings, edu/events/2014/O1/14-sentinel-ini- tiative-public-workshop ,2014-03-11.
  • 10EU-ADR[ EB/OL]. http://www, euadr-project, org/ ,2014- 03-11.

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二级引证文献17

药物流行病学杂志
2013年 第5期

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