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- W2047472639 abstract "In guideline E14, the American Food and Drug Administration (FDA) requests for clinical studies to investigate the prolongation of the heart rate corrected QT-interval (QTc) of the ECG. As drug induced QT-prolongation can be caused by changes in the repolarisation of the ventricles, it is so far a thorough ECG biomarker of risk for ventricular tachyarrhythmias and Torsade de Pointes (TdP). Ventricular repolarisation changes not only change QT but also influence the morphology of the T-wave. In a (400 mg single dose) Moxifloxacin positive control study both, QTc and several descriptors describing the T-wave morphology have been measured. Moxifloxacin is changing two shape dependent descriptors significantly (P<0.05) about 3 to 4 hours after a 400 mg oral single dose of Moxifloxacin." @default.
- W2047472639 created "2016-06-24" @default.
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- W2047472639 date "2011-08-01" @default.
- W2047472639 modified "2023-09-26" @default.
- W2047472639 title "Investigation of parameters highlighting drug induced small changes of the T-wave's morphology for drug safety studies" @default.
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- W2047472639 doi "https://doi.org/10.1109/iembs.2011.6090769" @default.
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