Thorough QT studies are typically conducted for drugs with systemic bioavailability and include a positive control, typically moxifloxacin, with a well-described QTc effect. This study tested two hypotheses: that (i) re-measuring the QT intervals based on electrocardiogram (ECG) pattern similarity improves the moxifloxacin time profile, and (ii) that study conduct influences the ability to detect … Continued
Publication: Drug Safety
Most drugs with systemic bioavailability have to undergo a thorough QT (TQT) study, which includes a pharmacologic positive control. A set of QTc-quality tests was recently proposed with the possible aim of removing the need for a positive control.