Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development

Bioanalysis

Volumn 3, Issue 5, 2011, Pages 535-540

  Cai, Xiao Yan ^a   Gouty, Dominique ^b   Baughman, Sharon ^c   Ramakrishnan, M S ^d   Cullen, Constance ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Alta Analytical Laboratory   (United States)

^c Intertek   (United States)

^d Biocon Limited   (India)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG ANTIBODY;

ACCURACY; ANALYTIC METHOD; BINDING ASSAY; DRUG DESIGN; DRUG DETERMINATION; DRUG TOLERANCE; IMMUNE RESPONSE; IMMUNOGENICITY; INTERMETHOD COMPARISON; LIGAND BINDING; REVIEW; SENSITIVITY AND SPECIFICITY; TOXICOKINETICS; VALIDITY;

ANIMALS; BIOLOGICAL PRODUCTS; DRUG INDUSTRY; DRUGS, GENERIC; GUIDELINES AS TOPIC; HUMANS; IMMUNITY;

EID: 79953096763     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.24     Document Type: Review

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