Statistical issues including design and sample size calculation in thorough QT/QTc studies

Journal of Biopharmaceutical Statistics

Volumn 18, Issue 3, 2008, Pages 451-467

  Zhang, Joanne ^a,b   Machado, Stella G ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b WO22 ^*  (United States)

Author keywords

QT QTc interval; Sample size; Study design; Thorough QT QTc (TQT) study

Indexed keywords

CARDIOVASCULAR AGENT; NONANTIARRHYTHMIC AGENT; PLACEBO; NEW DRUG;

ARTICLE; CALCULATION; CLINICAL TRIAL; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG SCREENING; DRUG TOLERABILITY; HEART PROARRHYTHMIA; HEART REPOLARIZATION; HUMAN; LATIN SQUARE DESIGN; METHODOLOGY; PARALLEL DESIGN; PRACTICE GUIDELINE; PRIORITY JOURNAL; QT INTERVAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; SENSITIVITY ANALYSIS; STATISTICAL ANALYSIS; STATISTICS; CHEMICALLY INDUCED DISORDER; DRUG EFFECT; ELECTROCARDIOGRAPHY; HEART RATE; INTERNATIONAL COOPERATION; LONG QT SYNDROME; PATHOPHYSIOLOGY; PHYSIOLOGY;

DRUGS, INVESTIGATIONAL; ELECTROCARDIOGRAPHY; GUIDELINES AS TOPIC; HEART RATE; HUMANS; INTERNATIONAL COOPERATION; LONG QT SYNDROME; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SAMPLE SIZE;

EID: 45849094068     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400802020938     Document Type: Article

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