Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies

Journal of Pharmaceutical and Biomedical Analysis

Volumn 39, Issue 3-4, 2005, Pages 364-375

  Geng, Dong ^a   Shankar, Gopi ^a   Schantz, Allen ^a   Rajadhyaksha, Manoj ^a   Davis, Hugh ^a   Wagner, Carrie ^a  

^a CENTOCOR INC   (United States)

Author keywords

Anti drug antibody; Assay validation; Enzyme immunoassay; Immunogenicity; Method validation

Indexed keywords

DRUG ANTIBODY; MONOCLONAL ANTIBODY;

ACCURACY; DILUTION; DRUG INDUSTRY; ENZYME IMMUNOASSAY; ENZYME LINKED IMMUNOSORBENT ASSAY; GOOD LABORATORY PRACTICE; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; MONITORING; PRIORITY JOURNAL; REVIEW; VALIDATION PROCESS;

ANIMALS; ANTIBODIES, MONOCLONAL; CHEMISTRY, PHARMACEUTICAL; DRUG INDUSTRY; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOASSAY; IMMUNOENZYME TECHNIQUES; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 23944447879     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2005.04.045     Document Type: Review

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