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• W351639134 abstract "Over the last two decades, several medicines were withdrawn from the market because their use in patients has been discovered to be associated with the development of a very specific potentially life-threatening polymorphic ventricular tachycardia, Torsade de pointes (TdP). In approximately 20 percent of the cases, TdP can develop into ventricular fibrillation and lead to sudden death. The recently finalized ICH S7B guideline defines the prolongation of the QT interval (measure of time between Q and T waves in the electrocardiogram) on the surface electrocardiogram as an appropriate biomarker for predicting the torsadogenic risk of a given compound. However, a growing body of evidence suggests that the QT interval prolongation is an incomplete biomarker of a drug's torsadogenic potential. The generation of TdP is triggered more by dynamic combination of multiple predisposing factors and components and favored by myocardial substrate rather than by a single electrophysiological event. Following recommendations of the respective guideline, the pharmaceutical industry has intensively implemented methodologies to assess the potential risk of QT prolongation and TdP in man. The key task of each cardiac safety testing strategy requires a case-by-case analysis; how to find the best combination of different test capabilities considering their strengths and limitations to detect the liability of a chemical structure to induce lethal arrhythmia of very low clinical incidence. This chapter will provide a brief overview on the current methodologies and considerations that are useful in predicting QT prolongation in man and/or a torsadogenic liability." @default.
• W351639134 created "2016-06-24" @default.
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• W351639134 date "2010-09-27" @default.
• W351639134 modified "2023-10-10" @default.
• W351639134 title "Cardiac safety" @default.
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• W351639134 doi "https://doi.org/10.1017/cbo9780511779053.005" @default.
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