Statistical methods for assessment of biosimilarity using biomarker data

Journal of Biopharmaceutical Statistics

Volumn 20, Issue 1, 2010, Pages 90-105

  Chow, Shein Chung ^a   Lu, Qingshu ^b   Tse, Siu Keung ^c   Chi, Eric ^d  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF SCIENCE AND TECHNOLOGY OF CHINA   (China)

^c CITY UNIVERSITY OF HONG KONG   (Hong Kong)

^d AMGEN INC   (United States)

Author keywords

Biosimilar; Follow on biologics; Fundamental biosimilar assumption; Moment based criterion; Probability based criterion

Indexed keywords

BIOLOGICAL MARKER; BIOLOGICAL PRODUCT;

ARTICLE; BIOEQUIVALENCE; CONFIDENCE INTERVAL; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; MATHEMATICAL COMPUTING; PARALLEL DESIGN; PRIORITY JOURNAL; PROBABILITY; STATISTICAL ANALYSIS;

ANIMALS; BIOLOGICAL PRODUCTS; BIOMARKERS, PHARMACOLOGICAL; HUMANS; MODELS, STATISTICAL; THERAPEUTIC EQUIVALENCY;

EID: 75649086457     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400903280373     Document Type: Article

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