Investigation of parameters highlighting drug induced small changes of the T-wave's morphology for drug safety studies
- Resource Type
- Conference
- Authors
- Baas, Tobias; Grafe, Ksenija; Khawaja, Antoun; Dossel, Olaf
- Source
- 2011 Annual International Conference of the IEEE Engineering in Medicine and Biology Society Engineering in Medicine and Biology Society, EMBC, 2011 Annual International Conference of the IEEE. :3796-3799 Aug, 2011
- Subject
- Bioengineering
Communication, Networking and Broadcast Technologies
Components, Circuits, Devices and Systems
Computing and Processing
Signal Processing and Analysis
Electrocardiography
Morphology
Drugs
Plasmas
Blood
Particle measurements
Correlation
- Language
- ISSN
- 1557-170X
1094-687X
1558-4615
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 tachyarrhyth-mias 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