Comparison of Highly-Automatic versus FDA-Submitted QT Measurements for the Detection of Moxifloxacin Induced Prolongation of the QTc Interval

被引：4

作者：

Handzel, R. ^{[1
,2
]}

Garnett, C. ^{[3
]}

Li, M. ^{[3
]}

McNitt, S. ^{[4
]}

Polonski, S. ^{[4
]}

Xia, X. ^{[4
]}

Couderc, J. P. ^{[4
]}

机构：

[1] Univ Rochester, CPU Box 274020, Rochester, NY 14627 USA

[2] Univ Rochester, Dept Biomed Engn, Rochester, NY 14627 USA

[3] CDER, US FDA, US Dept HHS, Silver Spring, MD USA

[4] Univ Rochester Med Ctr, Dept Cardiol, Heart Res Follow up Program, Rochester, NY USA

来源：

COMPUTERS IN CARDIOLOGY 2008, VOLS 1 AND 2 | 2008年

关键词：

D O I：

10.1109/CIC.2008.4749136

中图分类号：

TP [自动化技术、计算机技术];

学科分类号：

0812 ;

摘要：

In this study, we investigated the ability of a QT algorithm to detect small drug-induced QT interval prolongation by adopting a "highly-automatized" approach. In a set of 8,911 digital ECGs, we analyzed the drug-concentration profile of computerized QTc to the measurements submitted to the Food and Drug Administration (FDA) by pharmaceutical companies. The RR and QT intervals were measured using lead II based on a QT algorithm included in the COMPAS software package developed at University of Rochester Medical Center, NY. When comparing the time-dependent effect of the drug on the QTc interval the automatic technique produced results similar to the measurements reported by contract research organizations to the Agency (FDA).

引用

页码：693 / +

页数：2

共 9 条

[1]

[Anonymous], E14 ICH

[2]

COURDERC J, 2006, COMPUT CARDIOL, V33, P705

[3] Moxifloxacin: Clinical efficacy and safety [J].