Document Detail

Investigation of parameters highlighting drug induced small changes of the T-wave's morphology for drug safety studies.
MedLine Citation:
PMID:  22255166     Owner:  NLM     Status:  MEDLINE    
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.
Tobias Baas; Ksenija Gräfe; Antoun Khawaja; Olaf Dössel
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference     Volume:  2011     ISSN:  1557-170X     ISO Abbreviation:  Conf Proc IEEE Eng Med Biol Soc     Publication Date:  2011  
Date Detail:
Created Date:  2012-01-18     Completed Date:  2012-07-09     Revised Date:  2014-08-21    
Medline Journal Info:
Nlm Unique ID:  101243413     Medline TA:  Conf Proc IEEE Eng Med Biol Soc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3796-9     Citation Subset:  IM    
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MeSH Terms
Anti-Infective Agents / adverse effects*
Aza Compounds / adverse effects*
Electrocardiography / methods*
Quinolines / adverse effects*
Tachycardia, Ventricular / physiopathology
Torsades de Pointes / physiopathology
United States
United States Food and Drug Administration
Reg. No./Substance:
0/Anti-Infective Agents; 0/Aza Compounds; 0/Quinolines; U188XYD42P/moxifloxacin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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