Use of Exposure-Response (ER) Modeling of QTc Data – A Movement Away from a Thorough QT Study

Since 2005 the US Food and Drug Administration (FDA) has required the evaluation of a new molecular entity in a thorough QT (TQT) study, which is intended to determine a drug’s effect on the QT interval.  The QT interval represents the duration of ventricular depolarization and subsequent cardiac repolarization, measured from the beginning of the […]