Practical issues and observations on the use of foreign clinical data in drug development

Journal of Biopharmaceutical Statistics

Volumn 12, Issue 3, 2002, Pages 369-384

  Goto, Masashi ^a   Hamasaki, Toshimitsu ^b  

^a OSAKA UNIVERSITY   (Japan)

^b PFIZER INC   (United States)

Author keywords

Analogy; Empirical probability plot; Extrapolation; Generalized logistic model; Hierarchical hypotheses; Reproducibility; Similarity

Indexed keywords

NEW DRUG;

ARTICLE; CLINICAL STUDY; DATA ANALYSIS; DOSE RESPONSE; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG SCREENING; EUROPEAN UNION; JAPAN; PHARMACEUTICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROBABILITY; REGISTRATION; REGULATORY MECHANISM; STATISTICAL MODEL; STATISTICS; UNITED STATES;

BIOMEDICAL RESEARCH; CLINICAL TRIALS; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; GUIDELINES; MODELS, STATISTICAL; REPRODUCIBILITY OF RESULTS;

EID: 0036431436     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120014566     Document Type: Article

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