Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics

Statistics in Medicine

Volumn 32, Issue 3, 2013, Pages 424-433

  Zhang, Nan ^a   Yang, Jun ^a   Chow, Shein Chung ^b   Endrenyi, Laszlo ^c   Chi, Eric ^a  

^a AMGEN INC   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF TORONTO   (Canada)

Author keywords

Biosimilarity limit; Biosimilars; Highly variable biological products; Scaled biosimilarity margin

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR AGENT;

ARTICLE; BIOEQUIVALENCE; DRUG RESEARCH; MATHEMATICAL ANALYSIS; NORMAL DISTRIBUTION; PHARMACOKINETICS; STANDARD; VARIANCE;

ALGORITHMS; BIOSIMILAR PHARMACEUTICALS; DRUG EVALUATION;

EID: 84872418710     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5567     Document Type: Article

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