Comparison of highly-automatic versus FDA-submitted QT measurements for the detection of moxifloxacin induced prolongation of the QTc interval

Computers in Cardiology

Volumn 35, Issue , 2008, Pages 693-696

  Handzel, R ^a,c,d   Garnett, C ^b   Li, M ^b   McNitt, S ^c   Polonski, S ^c   Xia, X ^c   Couderc, J P ^c  

^a University of Rochester   (United States)

^b CDER   (United States)

^c UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

^d UNIVERSITY OF ROCHESTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AUTOMATIC TECHNIQUES; CONCENTRATION PROFILES; CONTRACT RESEARCH ORGANIZATIONS; FOOD AND DRUG ADMINISTRATIONS; MEDICAL CENTERS; MOXIFLOXACIN; PHARMACEUTICAL COMPANIES; TIME-DEPENDENT EFFECTS; UNIVERSITY OF ROCHESTER;

CARDIOLOGY;

EID: 62249185307     PISSN: 02766574     EISSN: None     Source Type: Conference Proceeding    
DOI: 10.1109/CIC.2008.4749136     Document Type: Conference Paper

References (9)

1. ICH Harmonized Tripartite Guideline E14. The Clinical evaluation of QT/QTc interval prolongation and proarrhytmic potential for non-antiarrhythmic drugs [online]. Available from URL: http://www.fda.goc/cderIGuidance16885(nl.htm [accessed 2008 May 21]
2. Culley C, Lacy M, et al. Moxifloxacin: Clinical Efficacy and Safety. Am J Health Syst Pharm 2001;58:379-88.
3. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. 2005. DIA meeting, Washington DC, May 2005.
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9. Kligfield P, Hancock E, Helfenbein E, et al. Relation of QT Interval Measurements to Evolving Automated Algorithms from Different Manufacturers of Electrocardiographs. Am J Cardiol. 2006;98:88-92.