Immunogenicity of mAbs in non-human primates during nonclinical safety assessment

mAbs

Volumn 5, Issue 5, 2013, Pages 810-816

  Van Meer, Peter J K ^a   Kooijman, Marlous ^b   Brinks, Vera ^a   Gispen De Wied, Christine C ^c   Silva Lima, Beatriz ^d   Moors, Ellen H M ^b   Schellekens, Huub ^a,b  

^a UTRECHT UNIVERSITY   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

^c MEDICINES EVALUATION BOARD   (Netherlands)

^d RESEARCH INSTITUTE FOR MEDICINES IMED ULISBOA   (Portugal)

Author keywords

Antidrug antibodies; Drug development; Immunogenicity; Monoclonal antibodies; Non clinical; Non human primates; Regulatory science; Safety assessment

Indexed keywords

ABCIXIMAB; ADALIMUMAB; ALEMTUZUMAB; ARCITUMOMAB TC 99M; BASILIXIMAB; BESILESOMAB; BEVACIZUMAB; CANAKINUMAB; CATUMAXOMAB; CERTOLIZUMAB PEGOL; CETUXIMAB; DACLIZUMAB; DENOSUMAB; ECULIZUMAB; EFALIZUMAB; GOLIMUMAB; IBRITUMOMAB TIUXETAN; IGOVOMAB IN 111; INFLIXIMAB; MONOCLONAL ANTIBODY; NATALIZUMAB; OFATUMUMAB; OKT 3; OMALIZUMAB; ONCOSPECT CR; ORTHOCLONE OKT 3; PALIVIZUMAB; PANITUMUMAB; RANIBIZUMAB; RITUXIMAB; SULESOMAB; SULESOMAB TC 99M; TECNEMAB K 1; TOCILIZUMAB; TRASTUZUMAB; UNCLASSIFIED DRUG; UNINDEXED DRUG; USTEKINUMAB; VOTUMUMAB TC 99M;

ARTICLE; DRUG SAFETY; IMMUNOGENICITY; RISK ASSESSMENT;

ANTIDRUG-ANTIBODIES; DRUG DEVELOPMENT; IMMUNOGENICITY; MONOCLONAL ANTIBODIES; NON-CLINICAL; NON-HUMAN PRIMATES; REGULATORY SCIENCE; SAFETY ASSESSMENT;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIBODY FORMATION; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPEAN UNION; HUMANS; MICE; PRIMATES; REGISTRIES;

EID: 84883865798     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.4161/mabs.25234     Document Type: Article

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