New confidence bounds for QT studies.
The proposed guidelines for the assessment of the effect of new pharmaceutical agents on the QT interval (beginning of QRS complex to end of T wave on the electrocardiogram) are based on the maximum of a series over time of simple one-sided 95 per cent upper confidence bounds. This procedure is typically very conservative as a procedure for obtaining a 95 per cent bound for the maximum of the population parameters. This paper proposes new bounds for the maximum, both analytical and bootstrap-based, that are lower but still achieve correct coverage in the context of crossover and parallel designs for the most realistic portions of the parameter space.
Boos
Dennis D
DD
Department of Statistics, North Carolina State University, P.O. Box 8203, Raleigh, NC 27695-8203, USA. boos@stat.ncsu.edu
Hoffman
David
D
Kringle
Robert
R
Zhang
Ji
J
D000465:Algorithms; D001145:Arrhythmias, Cardiac / Q000139:chemically induced* / Q000517:prevention & control; D000075202:Contraindications; D018592:Cross-Over Studies; D004341:Drug Evaluation / Q000706:statistics & numerical data*; D004562:Electrocardiography; D006801:Humans; D004364:Pharmaceutical Preparations; D014481:United States
D004364:Pharmaceutical Preparations