Group sequential design and analysis of clinical equivalence assessment for generic nonsystematic drug products

Journal of Biopharmaceutical Statistics

Volumn 14, Issue 2, 2004, Pages 359-373

  Tsong, Yi ^a   Zhang, Juan ^a   Wang, Sue Jane ^a  

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

Author keywords

Adaptive design; Group sequential; Hierarchical testing; Nonsystemic drug products

Indexed keywords

GENERIC DRUG; PLACEBO;

ARTICLE; BIOEQUIVALENCE; DRUG DESIGN; GROUP SEQUENTIAL DESIGN; MATHEMATICAL ANALYSIS; PRIORITY JOURNAL; REFERENCE VALUE; RESOURCE ALLOCATION; SAMPLE SIZE; SAMPLING;

CLINICAL TRIALS; DRUGS, GENERIC; THERAPEUTIC EQUIVALENCY;

EID: 2642575785     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120037186     Document Type: Article

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