Update on the evaluation of a new drug for effects on cardiac repolarization in humans: issues in early drug development.


Following reports of death from cardiac arrhythmias with drugs like terfenadine and cisapride, the International Conference for Harmonization formulated a guidance (E14) document. This specifies that all new drugs must undergo a 'thorough QT/QTc' (TQT) study to detect drug-induced QT prolongation, a surrogate marker of ventricular tachycardia, especially… (More)
DOI: 10.1111/j.1476-5381.2009.00427.x