| 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 |
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| 引用本文： | Daniel Liu. 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[J]. 中国临床药理学与治疗学, 2006, 11(1): 116-120 |
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| 作者姓名： | Daniel Liu |
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| 作者单位： | Meta Consultant, Inc. NJ 08820, USA |
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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。
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| 关 键 词： | 心脏 安全性 新药研发 国际药政法规 |
| 文章编号： | 1009-2501（2006）01-0116-05 |
| 收稿时间： | 2005-12-20 |
| 修稿时间： | 2005-12-25 |
ICH E14: a new global regulatory guideline on clinical evaluation of cardiac safety for new drug development programs |
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| Daniel Liu. ICH E14: a new global regulatory guideline on clinical evaluation of cardiac safety for new drug development programs[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(1): 116-120 |
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| Authors: | Daniel Liu |
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| Abstract: | 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. |
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| Keywords: | ICH E14 |
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