Incorporating exposure‐response modeling into the assessment of QTc interval: A potential alternative to the thorough QT study

ICH E14 mandates that a thorough QTc study (TQT) is conducted as part of the clinical drug development program to provide an accurate and precise estimate of a drug's effect on the QTc. In the April issue of CPT , Darpo et al . report the results of a study which validated an alternative approach to evaluating the effect of a drug on QTc using exposure‐response modeling in phase I which has the potential to make the TQT study obsolete.