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综合性体外致心律失常评价|药物筛选服务|离子通道服务|激酶谱筛选|膜片钳服务
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综合性体外致心律失常评价|药物筛选服务|离子通道服务|激酶谱筛选|膜片钳服务

  • 心脏复极毒性（QT间期延长及尖端扭转型室性心动过速）是严重而广泛的不良反应，撤市的药物中1/3由于药物致心律失常不良反应导致。

  • 抑制hERG钾通道，是致心律失常毒性的主要原因。2005年颁布的ICHS7B要求所有申报阶段的供试品必须有对hERG抑制率的数据，cF DA（NMPA）的“药物QT间期延长潜在作用非临床研究技术指导原则”（2014）也有相应规定。 、

  • hERG作为评价药物致心律失常毒性的主要指标，敏感性和特异性都存在比较严重的问题，因此，2013年FDA开始推动综合性体外致心律失常评 价（CiPA, Comprehensive in vitro Proarrhythmia Assay）。

  • CiPA包括四个核心环节：（1）心脏多种离子通道评价（2）动作电位的计算机虚拟重建（3）iPSC诱导分化心肌细胞模型（4）临床心电图评 估。

  • ICH关于CiPA的时间计划表：2020年6月，将以ICHS7B Q&A的更新形式推出。

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爱思益普体外心脏安全性评价服务

1，心脏多离子通道作用研究

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2，干细胞诱导分化心肌细胞动作电位

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3，浦肯野纤维动作电位

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Location : 北京市通州区科创十三街与经海路交汇处, 100176 beijing,
Contact : Huanyu Shang, +17 3 56 52 16 13

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