Early clinical development: Evaluation of drug-induced torsades de pointes risk☆

Abstract Drug-induced arrhythmias or QT interval prolongation is one of the two most common reasons for drugs to be denied regulatory approval or to have warnings imposed on their clinical labelling. The assessment of torsades de pointes (TdP) risk during clinical development of a new pharmaceutical compound has been an issue of debate since the original description of drug-induced proarrhythmia. TdP risk assessment is complicated by the very low incidence (e.g.,