Comparison of semiautomated and fully automated methods for QT measurement during a thorough QT/QTc study: Variability and sample size considerations

Journal of Clinical Pharmacology

Volumn 49, Issue 8, 2009, Pages 905-915

  Tyl, Benoít ^a   Kabbaj, Meriam ^b   Fassi, Basmah ^a   De Jode, Patrick ^a   Wheeler, William ^a  

^a Centralized Cardiac Services   (France)

^b PK/PD   (Switzerland)

Author keywords

Drug safety; QT interval; QT prolongation; Repolarization; Thorough QT QTc study

Indexed keywords

MOXIFLOXACIN; PLACEBO; HETEROCYCLIC COMPOUND; QUINOLINE DERIVATIVE;

ADULT; AGED; ARTICLE; AUTOMATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; ELECTROCARDIOGRAM; ELECTROCARDIOGRAPHY; FEMALE; HUMAN; MALE; NORMAL HUMAN; QT INTERVAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; STATISTICAL SIGNIFICANCE; COMPARATIVE STUDY; COMPUTER ASSISTED DIAGNOSIS; CROSSOVER PROCEDURE; METHODOLOGY; MIDDLE AGED; SAMPLE SIZE; SENSITIVITY AND SPECIFICITY;

ADULT; AGED; AZA COMPOUNDS; CROSS-OVER STUDIES; DIAGNOSIS, COMPUTER-ASSISTED; DOUBLE-BLIND METHOD; ELECTROCARDIOGRAPHY, AMBULATORY; FEMALE; HUMANS; MALE; MIDDLE AGED; QUINOLINES; SAMPLE SIZE; SENSITIVITY AND SPECIFICITY; YOUNG ADULT;

EID: 70349306367     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270009337944     Document Type: Article

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