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ICH E14:一项新的评价新药研发中药物临床心脏安全性的国际药政法规 被引量：7

ICH E14: a new global regulatory guideline on clinical evaluation of cardiac safety for new drug development programs
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摘要 2005年5月,有关在临床研究中如何监督新药对心脏安全性的措施,经国际协调会议(ICH)讨论并通过了一项新的工作指南,即ICH协调性三方指南:非抗心律不齐药物的致QT/QTc间期延长和致心律失常的临床评价。本文概述并讨论了该指南要点,以期望对相关新药安全性监督起到一定指导作用。 In May 2005, resolutions on how cardia safety of a new drug should be monitored during its clinical studies were concluded with publication of an intensive International Conference on Harmonization （ICH） process, leading to the document： ICH Harmonized Tripatite Guideline： The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non - antiaahythmic drugs （ICH E 14）. The review presented this guidance with commentary on areas requiring more clarifications that will be useful in developing China＇ s strategies of cardiac safety programs of new drugs to ensure compliance with good clinical practice.
作者 Daniel Liu
机构地区 Meta Consultant
出处 《中国临床药理学与治疗学》 CAS CSCD 2006年第1期116-120,共5页 Chinese Journal of Clinical Pharmacology and Therapeutics
关键词 ICH E14 心脏 安全性 新药研发 国际药政法规 ICH E14 heart security new drug exploiture international
分类号 R969 [医药卫生—药理学]
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参考文献11

  • 1International Conference on Harmonization.E14:the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (step 4)[EB/OL].http://www.ich.org/cache/compo/276-254-1.html.2005-7-15
  • 2International Conference on Harmonization.S7B:the nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals[EB/OL].http://www.ich.org/cache/compo/276-254-1.html
  • 3ICH Harmonized Tripartite Guideline:The non-clinical evaluation of the potential for delayed ventricular polarization (QT interval prolongation) by human pharmaceuticals[S].S7B,Step 4,12 May 2005,Page 2,Section 2.1
  • 4ICH Harmonized Tripartite Guideline:The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs[S].E14,Step 4,12 May 2005,Page 3,section 2.2
  • 5ICH Harmonized Tripartite Guideline:The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs[S].E14,Step 4,12 May 2005,Page 4,Section 2.2.1
  • 6ICH Harmonised Tripartite Guideline:The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs[S].E14,Step 4,12 May 2005,Page 3-4,Section 2.2.1
  • 7ICH Harmonised Tripartite Guideline:The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs[S].E14,12 May 2005,Page 5,Section 2.2.4
  • 8Committee for proprietary medicinal products.Points to Consider:the assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products[EB/OL].December 17,1997.http://www.emea.eu.int./pdfs/human/swp/098696en.pdf.1997-12-17/2005-7-15
  • 9Shah,RR.Drugs,QT interval prolongation and ICH E14:the need to get it right[J].Drug Safety,2005; 28:115-2510ICH Harmonised Tripartite Guideline:The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs[S].E14,Step 4,12 May 2005,Page 8,Section 3.1
  • 10ICH Harmonised Tripartite Guideline:The clinica levaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs[S].E14,Step 4,12 May 2005,Page 9,Section 3.1.2

同被引文献56

  • 1陈勤奋,李佩,范学良,张少峰,李中东,梁晓华,陈彤,谢彦晖,谢毅.二乙酰己二胺治疗骨髓增生异常综合征患者的Ⅰ期临床研究[J].中华内科杂志,2004,43(7):534-535. 被引量：5
  • 2胡胜,臧爱华,付小玉.癌症药物治疗中的心血管并发症[J].中国肿瘤,2007,16(2):106-109. 被引量：5
  • 3International Conference on Harmonization. E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drug(step 4) [ EB/OL]. (2005 - 7 - 15). http://ich, org/cache/compo/276 -254 - 1. htmL.
  • 4SORENSEN K, LEVITT GA, BULL C, et al. Late anthracycline cardiotoxicity after childhood cancer: a prospective longitudinal study [ J ]. Cancer, 2003,97 ( 8 ) : 1991 - 1998.
  • 5International conference on harmonization. El4: the clinical evaluation of QT/QTe interval prolongation and proarrhythmie potential for non-antiarrhythmie drug( step 4 )[EB/OL]. ( 2005 - 07 - 15). http://ieh, org/eaehe/compo/276 -254 - 1. html.
  • 6Common terminology criteria for adverse events v3.0 (CTCAE) [ EB/OL]. (2006 -08 -09). http://ctep, cancer, gov/forms/ CTCAEv3. pdf.
  • 7DIXON R, JOB S, OLIVER R, et al. Lamotrigine does not prolong QTc in a thorough QT/QTc study in healthy subjects[J]. Br J Clin Pharmacol, 2008, 66(3): 396-404.
  • 8MALHOTRA BK, GLUE P, SWEENEY K, et al. Thorough QT study with recommended and supratherapeutic doses of tolterodine [J]. Clin Pharmacol Ther, 2007, 81(2): 377-355.
  • 9SARAPA N, NICKENS DJ, RABER SR, et al. Ritonavir 100 mg does not cause QTc prolongation in healthy subjects: a pos- sible role as CYP3A inhibitor in thorough QTc studies[J]. Clin Pharmacol Ther, 2008, 83(1): 153-159.
  • 10CoreLab. CoreLab partners completes first TQT study in Japan [EB/OL]. (2010-10-06) [2011-06-01]. http ://corelabpartners. com/News-Events/CoreLab-Partners-completes-first-TQT-study-in- Japa.aspx.

引证文献7

二级引证文献26

中国临床药理学与治疗学
2006年 第1期

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