Drugs, QT Interval Prolongation and ICH E14The Need to Get it Right

被引：0
|
作者：
Rashmi R. Shah
机构：
[1] Market Towers,Medicines and Healthcare products Regulatory Agency
来源：
Drug Safety | 2005年 / 28卷
关键词：
Moxifloxacin; Ziprasidone; Ventricular Repolarisation; Guidance Note; Nonclinical Study;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Regulatory concerns on the ability of an ever-increasing number of non-cardiovascular drugs to prolong the corrected QT (QTc) interval and induce potentially fatal ventricular tachyarrhythmias have culminated in initiatives to harmonise internationally the regulatory guidance on strategies by which to evaluate new drugs for this liability. The International Conference on Harmonisation (ICH) has released consensus texts for clinical (ICH topic E14) and non-clinical (ICH topic S7B) strategies as regulatory drafts for wider consultation.
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页码：115 / 125
页数：10
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