ICH E9 guideline 'Statistical principles for clinical trails': A case study

Statistics in Medicine

Volumn 22, Issue 1, 2003, Pages 1-11

  Phillips, Alan ^a   Haudiquet, Vincent ^b  

^a PFIZER INC   (United States)

^b Wyeth Lederle   (France)

Author keywords

Dose response; ICH E9; Magnitude of effect; Missing data; Multiple primary variables; Multiple treatment comparisons; Statistical regulatory guidelines

Indexed keywords

ANALGESIC AGENT; DYNODRUG; PLACEBO; UNCLASSIFIED DRUG;

ARTICLE; BIOSTATISTICS; CASE STUDY; CLINICAL PRACTICE; CLINICAL TRIAL; DOSE RESPONSE; DRUG CONTROL; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG SYNTHESIS; HUMAN; PAIN; PRACTICE GUIDELINE; STATISTICAL ANALYSIS;

DATA INTERPRETATION, STATISTICAL; DRUG APPROVAL; DRUG INDUSTRY; EUROPEAN UNION; GUIDELINES; HUMANS; JAPAN; LEGISLATION, DRUG; PHARMACEUTICAL PREPARATIONS; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; UNITED STATES;

EID: 0037438658     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1328     Document Type: Article

References (8)

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