(三)追加的研究
药物对心肌动作电位(Action potential,AP)的影响:心脏的正常功能依赖于心肌细胞动作电位的产生和传导。药物引起细胞膜离子通道表达或功能异常是其导致心律失常的重要病理生理基础。因此,在离体心脏标本进行动作电位参数测定,是ICH 推荐的QT间期延长药物安全性评价体系中的重要组成之一。常用于动作电位参数测定的动物离体心脏标本及试验方法见表4,试验中重要的参数项目见表5。
表4 记录心肌AP的离体心肌标本
动物标本
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上述研究相关试验建议最大可能执行GLP
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