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This review discusses clinical and preclinical screening methods for anticipating malignant ventricular arrhythmias caused by drugs that alter ventricular repolarization, along with regulatory implications.
Many drugs are found to alter ventricular repolarization, as manifest by T-wave and U-wave changes on the surface electrocardiogram. These changes have frequently been associated with malignant ventricular arrhythmias. There is no perfectly sensitive and specific way of anticipating such arrhythmias, but some clinical and preclinical screening methods are better than others. The author reviews some of these methods, commenting on some of the regulatory implications.
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Robert R. Fenichel (2002) studied this question.
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