Comparison of Manual and Automated Measurements of the QT Interval in Healthy Volunteers: An Analysis of Five Thorough QT Studies

被引：24

作者：

Fosser, C. ^{[2
]}

Duczynski, G. ^{[2
]}

Agin, M. ^{[3
]}

Wicker, P. ^{[1
,4
]}

Darpo, B. ^{[5
]}

机构：

[1] PW Consulting LLC, Mystic, CT USA

[2] Pfizer Inc, Pfizer Global Res & Dev, New London, CT USA

[3] MM&T Associates LLC, Ann Arbor, MI USA

[4] Spacelabs Clin Trial Serv, Seattle, WA USA

[5] Karolinska Inst, Dept Med, Stockholm & Cardiol Unit, Stockholm, Sweden

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2009年 / 86卷 / 05期

关键词：

ECG; REPRODUCIBILITY;

D O I：

10.1038/clpt.2009.34

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

We analyzed five crossover, thorough QT (TQT) studies to compare automated, manual, and computer-assisted (CA) measurement methods. All the methods detected moxifloxacin-induced, baseline-adjusted, placebo-subtracted mean changes in Fridericia-corrected QT interval (QTcF), with peak effect ranging from 10 to 21 ms. The variability associated with manual and CA measurements was generally 5-28% greater than that associated with automated methods. The performances of automated, manual, and CA measurements were comparable for the purpose of demonstrating assay sensitivity in TQT studies with healthy volunteers.

引用

页码：503 / 506

页数：4

共 14 条

[1] Comparing methods of measurement for detecting drug-induced changes in the QT interval: Implications for thoroughly conducted ECG studies [J].