Comparison of manual and automated measurements of the QT interval in healthy volunteers: an analysis of five thorough QT studies.
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.
Fosser
C
C
Pfizer Global Research and Development, Pfizer, Inc., New London, Connecticut, USA.
Duczynski
G
G
Agin
M
M
Wicker
P
P
Darpo
B
B