Impact of baseline ECG collection on the planning, analysis and interpretation of 'thorough' QT trials

Pharmaceutical Statistics

Volumn 8, Issue 2, 2009, Pages 113-124

  Sethuraman, Venkat ^a   Sun, Qiankun ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Baseline; ECGs; Thorough QT study; Time averaged; Time matched

Indexed keywords

MOXIFLOXACIN; ANTIARRHYTHMIC AGENT;

ARTICLE; CIRCADIAN RHYTHM; CLINICAL TRIAL; CORRELATION COEFFICIENT; ELECTROCARDIOGRAM; EXPERIMENTAL DESIGN; HEART RATE; HUMAN; INFERENTIAL STATISTICS; METHODOLOGY; NORMAL DISTRIBUTION; NULL HYPOTHESIS; QT INTERVAL; SAMPLE SIZE; SIMULATION; SINGLE DRUG DOSE; STANDARDIZATION; STATISTICAL ANALYSIS; TIME SERIES ANALYSIS; COMPARATIVE STUDY; COMPUTER SIMULATION; DRUG EFFECT; ELECTROCARDIOGRAPHY; HEART MUSCLE CONDUCTION SYSTEM; RANDOMIZED CONTROLLED TRIAL; REFERENCE VALUE; STANDARD; STATISTICS; TIME;

ANTI-ARRHYTHMIA AGENTS; COMPUTER SIMULATION; ELECTROCARDIOGRAPHY; HEART CONDUCTION SYSTEM; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REFERENCE VALUES; RESEARCH DESIGN; STATISTICS AS TOPIC; TIME FACTORS;

EID: 69149103553     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.338     Document Type: Article

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