Sample size for equivalence trials: A case study from a vaccine lot consistency trial

Statistics in Medicine

Volumn 27, Issue 19, 2008, Pages 3743-3754

  Ganju, Jitendra ^a   Izu, Allen ^b   Anemona, Alessandra ^c  

^a AMGEN INC   (United States)

^b Novartis Vaccines and Diagnostics Inc   (United States)

^c NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

Author keywords

Equivalence; Power; Sample size; Vaccine lot consistency; Variance components

Indexed keywords

MENINGOCOCCUS VACCINE;

ANALYSIS OF COVARIANCE; ANTIBODY TITER; ARTICLE; CLINICAL TRIAL; CORRELATION ANALYSIS; DRUG EFFICACY; DRUG MANUFACTURE; HUMAN; MATHEMATICAL COMPUTING; MENINGOCOCCOSIS; NEISSERIA MENINGITIDIS; NORMAL DISTRIBUTION; NULL HYPOTHESIS; SAMPLE SIZE; SCORING SYSTEM; SIMULATION; STANDARDIZATION; VACCINATION;

CLINICAL TRIALS AS TOPIC; DRUG EVALUATION; HUMANS; QUALITY CONTROL; SAMPLE SIZE; THERAPEUTIC EQUIVALENCY; VACCINES;

EID: 50449086775     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3273     Document Type: Article

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