New confidence bounds for QT studies.

Abstract:

: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.

journal_name

Stat Med

journal_title

Statistics in medicine

authors

Boos DD,Hoffman D,Kringle R,Zhang J

doi

10.1002/sim.2826

subject

Has Abstract

pub_date

2007-09-10 00:00:00

pages

3801-17

issue

20

eissn

0277-6715

issn

1097-0258

journal_volume

26

pub_type

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