作者: R.A. Bialecki , P. Lainee , J.P. Valentin
DOI: 10.1016/B978-0-08-046884-6.00718-1
关键词: Adverse drug reaction 、 Intensive care medicine 、 Risk management 、 Risk assessment 、 hERG 、 Long QT syndrome 、 Cardiology 、 Cardiac arrhythmia 、 Internal medicine 、 Adverse effect 、 QT interval 、 Medicine
摘要: Cardiovascular adverse events are a leading cause of drug withdrawal from the marketplace and late-stage attrition in research development. Drug-induced or iatrogenic long QT syndrome is characterized by acquired interval prolongation increased risk torsade de pointes (TdP)-type arrhythmia. This chapter provides an overview reasons for arrhythmia mediated discontinuation as well comprehensive major regulatory guidances germane to this issue. Applicable experimental models including essential core battery studies described with subsequent considerations relevant assessment, management mitigation. Advantages analyzing data using integrated assessment approach highlighted. In addition, current challenges future directions discussed.