Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium
作者:
Rup, B. [1]
;
Pallardy, M. [2]
;
Sikkema, D. [3]
;
Albert, T. [4]
;
Allez, M. [5]
;
Broet, P. [6]
;
Carini, C. [7]
;
Creeke, P. [8]
;
Davidson, J. [9]
;
De Vries, N. [10]
;
Finco, D. [11]
;
Fogdell-Hahn, A. [12]
;
Havrdova, E. [13]
;
Hincelin-Mery, A. [14]
;
Holland, M. C. [15]
;
Jensen, P. E. H. [16]
;
Jury, E. C. [17]
;
Kirby, H. [18]
;
Kramer, D. [19]
;
Lacroix-Desmazes, S. [20]
;
Legrand, J. [21]
;
Maggi, E. [22]
;
Maillere, B. [23]
;
Mariette, X. [24]
;
Mauri, C. [25]
;
Mikol, V. [26]
;
Mulleman, D. [27]
;
Oldenburg, J. [28]
;
Paintaud, G. [29]
;
Pedersen, C. R. [30]
;
Ruperto, N. [31]
;
Seitz, R. [32]
;
Spindeldreher, S. [33]
;
Deisenhammer, F.
作者单位:
GlaxoSmithKline, Worldwide Epidemiol, Southall, Middx, England
[1]
Sanofi Aventis, Struct Biol, Paris, France
[2]
Novartis Inst Biomed Res, Drug Metab Pharmacokinet Biol, Basel, Switzerland
[3]
Ipsen Innovat, Pharmacokinet Drug Metab Dept, Les Ulis, France
[4]
CEA Saclay, Inst Biol & Technol, F-91191 Gif Sur Yvette, France
[5]
Ist Giannina Gaslini, Pediat 2, Rheumatol, I-16148 Genoa, Italy
[6]
UCL, Ctr Rheumatol, London, England
[7]
Novo Nordisk, Immunogen, Malov, Denmark
[8]
Univ Paris 06, INSERM, UMR S 1138, Paris, France
[9]
Univ Copenhagen, Dept Neurol, Copenhagen, Denmark
[10]
GlaxoSmithKline, Clin Immunol Biopharm R&D, King Of Prussia, PA USA
[11]
Univ Paris 11, INSERM, UMR996, Fac Pharm, Orsay, France
[12]
Pfizer, Drug Safety R&D, Groton, CT USA
[13]
Charles Univ Prague, Dept Neurol, MS Ctr, Prague, Czech Republic
[14]
Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden
[15]
Hop Univ Paris Sud, INSERM, U1012, Rhumatol, Paris, France
[16]
Paul Ehrlich Inst, Div Haematol Transfus Med, Langen, Germany
[17]
GlaxoSmithKline, Clin Immunol Biopharm, King Of Prussia, PA USA
[18]
Med Univ Innsbruck, Dept Neurol, A-6020 Innsbruck, Austria
[19]
UCL, Ctr Rheumatol Res, London, England
[20]
Univ Paris 11, INSERM, UMR669, Orsay, France
[21]
Univ Paris 11, Pfizer Immunogen Sci Disciple Pharmacokinet Dynam, Orsay, France
[22]
Univ Tours Francois Rabelais, CNRS UMR 7292, Tours, France
[23]
UCB Pharma, Bioanalyt R&D, Slough, Berks, England
[24]
CNRS UMR 7292 GICC, Fac Med, Tours, France
[25]
Pfizer, Early Biotech Clin Dev, Cambridge, MA USA
[26]
Queen Mary Univ London, Blizard Inst, Ctr Neurosci & Trauma, London, England
[27]
Univ Clin Bonn, Inst Expt Haematol & Transfus Med, Bonn, Germany
[28]
Hop St Louis, Dept Gastroenterol, GETAID, Paris, France
[29]
Univ Amsterdam, Clin Immunol & Rheumatol, Amsterdam, Netherlands
[30]
Sanofi Aventis Clin Exploratory & Pharmacol, Chilly Mazerin, France
[31]
Merck Serono, Inst Drug Metab & Pharmacokinet, Grafing, Germany
[32]
Univ Florence, Dipartimento Med Sperimentale & Clin, Florence, Italy
[33]
发布时间
2015-11-05
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Clinical and Experimental Immunology
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