Validation testing in thorough QT/QTc clinical trials

Journal of Biopharmaceutical Statistics

Volumn 18, Issue 3, 2008, Pages 529-541

  Tsong, Yi ^a   Zhong, Jinglin ^a   Chen, Wen Jen ^a  

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

Author keywords

Assay sensitivity; Controlling Type I error rate; QT prolongation; Statistical testing

Indexed keywords

MOXIFLOXACIN; ANTIINFECTIVE AGENT; HETEROCYCLIC COMPOUND; PLACEBO; QUINOLINE DERIVATIVE;

ANALYTICAL ERROR; ARTICLE; DATA ANALYSIS; HYPOTHESIS; METHODOLOGY; PRIORITY JOURNAL; QT INTERVAL; QT PROLONGATION; QUALITY CONTROL; STATISTICAL ANALYSIS; VALIDATION PROCESS; CHEMICALLY INDUCED DISORDER; CONTROL GROUP; DRUG EFFECT; ELECTROCARDIOGRAPHY; HEART RATE; HUMAN; LONG QT SYNDROME; PATHOPHYSIOLOGY; PHYSIOLOGY; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL; STANDARD; STATISTICS; VALIDATION STUDY;

ANTI-INFECTIVE AGENTS; AZA COMPOUNDS; CONTROL GROUPS; ELECTROCARDIOGRAPHY; GUIDELINES AS TOPIC; HEART RATE; HUMANS; LONG QT SYNDROME; PLACEBOS; QUINOLINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; VALIDATION STUDIES AS TOPIC;

EID: 45849137867     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400801995486     Document Type: Article

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