Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products

Journal of Pharmaceutical and Biomedical Analysis

Volumn 48, Issue 5, 2008, Pages 1267-1281

  Shankar, Gopi ^a   Devanarayan, Viswanath ^b   Amaravadi, Lakshmi ^c   Barrett, Yu Chen ^d   Bowsher, Ronald ^e   Finco Kent, Deborah ^f   Fiscella, Michele ^g   Gorovits, Boris ^h   Kirschner, Susan ⁱ   Moxness, Michael ^j   Parish, Thomas ^k   Quarmby, Valerie ^l   Smith, Holly ^m   Smith, Wendell ⁿ   Zuckerman, Linda A ^o   Koren, Eugen ^p  

^a CENTOCOR INC   (United States)

^b ABBOTT LABORATORIES   (United States)

^c BIOGEN   (United States)

^d BRISTOL MYERS SQUIBB   (United States)

^e USA   (United States)

^f PFIZER INC   (United States)

^g GLAXOSMITHKLINE   (United States)

^h WYETH RESEARCH   (United States)

ⁱ CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^j AMGEN INC   (United States)

^k PROCTER AND GAMBLE PHARMACEUTICALS   (United States)

^l GENENTECH INC   (United States)

^m ELI LILLY AND COMPANY   (United States)

ⁿ B2S Consulting   (United States)

^o ZYMOGENETICS INC   (United States)

^p ABBOTT VASCULAR   (United States)

more..

Author keywords

Anti drug antibody; Immunoassay; Immunogenicity; Method validation

Indexed keywords

DRUG ANTIBODY;

ACCURACY; ANTIBODY DETECTION; ANTIBODY RESPONSE; BIOTECHNOLOGY; CALCULATION; CORRELATION ANALYSIS; DRUG EXPOSURE; DRUG INDUSTRY; IMMUNOASSAY; IMMUNOGENICITY; LABORATORY TEST; PHARMACODYNAMICS; PRIORITY JOURNAL; QUALITY CONTROL; RELIABILITY; REVIEW; SENSITIVITY ANALYSIS; VALIDATION PROCESS;

ANIMALS; ANTIBODIES; BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; HEALTH PLANNING GUIDELINES; HUMANS; IMMUNOASSAY; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS;

EID: 58249116651     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2008.09.020     Document Type: Review

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