FDA 发布 E14 非抗心律失常药物 QT/QTc 间期延长与致心律失常潜力临床评价指南最终版（Docket FDA-2004-D-0241）

E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

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FDA 发布 E14 指南最终版（Docket FDA-2004-D-0241），就非抗心律失常药物延迟心脏复极潜力的临床研究设计、实施、分析与解读向申办者提出建议。评估应包括新药对 QT/QTc 间期的影响及心血管不良事件收集，具体研究方法需结合产品药效学、药代动力学、安全性特征及拟定临床用途个体化确定。

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GUIDANCE DOCUMENT

Final

Docket Number:

FDA-2004-D-0241

Issued by:

Guidance Issuing Office

Center for Biologics Evaluation and Research

Center for Drug Evaluation and Research

This guidance provides recommendations to sponsors concerning the design, conduct, analysis, and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarization. This assessment should include testing the effects of new agents on the QT/QTc interval as well as the collection of cardiovascular adverse events. The investigational approach used for a particular drug should be individualized, depending on the pharmacodynamic, pharmacokinetic, and safety characteristics of the product, as well as on its proposed clinical use.

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