Clinical Pharmacology & Therapeutics · 2009 · 33 citations · 9 references
MedicinePharmacokineticsPharmacologyClinical PharmacologyExperimental PharmacologyPharmacovigilanceBioanalytical Method ValidationDrug Efficacy AssessmentTime To Peak AnalysisAssayAssay SensitivityClinical Pharmacology EvidencePeak TimeQt Interval AnalysisQt Interval AssessmentQuantitative Drug AssayThorough Qt Study
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.
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