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Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium.
Rup, B; Pallardy, M; Sikkema, D; Albert, T; Allez, M; Broet, P; Carini, C; Creeke, P; Davidson, J; De Vries, N; Finco, D; Fogdell-Hahn, A; Havrdova, E; Hincelin-Mery, A; C Holland, M; H Jensen, P E; Jury, E C; Kirby, H; Kramer, D; Lacroix-Desmazes, S; Legrand, J; Maggi, E; Maillère, B; Mariette, X; Mauri, C; Mikol, V; Mulleman, D; Oldenburg, J; Paintaud, G; R Pedersen, C; Ruperto, N; Seitz, R; Spindeldreher, S; Deisenhammer, F.
Affiliation
  • Rup B; Pfizer, Immunogenicity Sciences Disciple, Pharmacokinetics, Dynamics and Metabolism.
  • Pallardy M; INSERM, UMR996, Faculté Pharmacie, Université Paris Sud, France.
  • Sikkema D; GlaxoSmithKline, Clinical Immunology-Biopharm, King of Prussia, PA, USA.
  • Albert T; Institute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, Bonn, Germany.
  • Allez M; Hôpital Saint-Louis, Department of Gastroenterology, GETAID, Paris, France.
  • Broet P; INSERM, UMR669, University of Paris Sud, France.
  • Carini C; Pfizer, Early Biotech Clinical Development, Cambridge, MA, USA.
  • Creeke P; Centre for Neuroscience and Trauma, Blizard Institute, Queen Mary University of London, London, UK.
  • Davidson J; GlaxoSmithKline, Worldwide Epidemiology, Southall, UK.
  • De Vries N; Clinical Immunology and Rheumatology, University of Amsterdam, Amsterdam, the Netherlands.
  • Finco D; Pfizer, Drug Safety R&D, Groton, CT, USA.
  • Fogdell-Hahn A; Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
  • Havrdova E; Department of Neurology and Center for Clinical Neuroscience, MS Center, Charles University in Prague, Prague, Czech Republic.
  • Hincelin-Mery A; Sanofi-Aventis, Clinical Exploratory and Pharmacology, Chilly-Mazerin, FR.
  • C Holland M; GlaxoSmithKline, Clinical Immunology-Biopharm R&D, King of Prussia, PA, USA.
  • H Jensen PE; Department of Neurology, University of Copenhagen, Copenhagen, Denmark.
  • Jury EC; Centre for Rheumatology, University College London, London, UK.
  • Kirby H; UCB Pharma, Bioanalytical R&D, Slough, UK.
  • Kramer D; Merck-Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany.
  • Lacroix-Desmazes S; INSERM, UMR S 1138, Université Pierre et Marie Curie, Paris, France.
  • Legrand J; Ipsen Innovation, Pharmacokinetics Drug Metabolism Department, Les Ulis, France.
  • Maggi E; Dipartimento di Medicina Sperimentale e Clinica, Universita di Firenze, Firenze, Italy.
  • Maillère B; CEA-Saclay Institute of Biology and Technologies, Gif sur Yvette, France.
  • Mariette X; INSERM, U1012, Hôpitaux Universitaires Paris Sud, Rhumatologie, Paris, France.
  • Mauri C; Centre for Rheumatology Research, University College London, London, UK.
  • Mikol V; Sanofi Aventis, Structural Biology, Paris, France.
  • Mulleman D; University of Tours Francois Rabelais, CNRS UMR 7292, Tours, France.
  • Oldenburg J; Institute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, Bonn, Germany.
  • Paintaud G; CNRS UMR 7292 'GICC', Faculty of Medicine, Tours, France.
  • R Pedersen C; Novo Nordisk, Immunogenicity, Måløv, Denmark.
  • Ruperto N; Istituto Giannina Gaslini, Pediatria II, Rheumatology, Genova, Italy.
  • Seitz R; Division of Haematology/Transfusion Medicine, Paul-Ehrlich-Institut, Langen, Germany.
  • Spindeldreher S; Drug Metabolism Pharmacokinetics-Biologics, Novartis Institutes for Biomedical Research, Basel, Switzerland.
  • Deisenhammer F; Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.
Clin Exp Immunol ; 181(3): 385-400, 2015 Sep.
Article in En | MEDLINE | ID: mdl-25959571
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Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 Database: MEDLINE Main subject: Drugs, Investigational / Guidelines as Topic / Drug Hypersensitivity / Terminology as Topic Type of study: Guideline / Prognostic_studies Limits: Humans Language: En Journal: Clin Exp Immunol Year: 2015 Document type: Article
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 Database: MEDLINE Main subject: Drugs, Investigational / Guidelines as Topic / Drug Hypersensitivity / Terminology as Topic Type of study: Guideline / Prognostic_studies Limits: Humans Language: En Journal: Clin Exp Immunol Year: 2015 Document type: Article