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Following the ICH E14 clinical evaluation guideline, the measurement of QT/QTc interval prolongation has become the standard surrogate biomarker for cardiac drug safety assessment and the faith of a drug development. In Thorough QT (TQT) study, a so-called positive control is employed to assess the ability of this study to detect the endpoint of interest, i.e. the QT prolongation by about five milliseconds...
Today, the pharmaceutical industry relies on ECG recordings (digital Holter or 12 lead resting ECG) to ensure cardiac safety of subjects in drug trials. State of the art is a central ECG analysis in ECG core labs, where the ECGs are analyzed fully manual by specially trained technicians or experienced cardiologists. The ECGs are commonly analyzed within 48 hours after upload to the core lab, independent...
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