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When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform.
Lotz, Gregor P; Benstein, Karin; Bloem, Karien; Buddiger, Harm; Calonder, Claudio; Elm, Stefanie; Fernandez, Elena; Goodman, Joanne; Gorovits, Boris; Grudzinska-Goebel, Joanna; Janssen, Melody; Jawa, Vibha; Kramer, Daniel; Luo, Linlin; Malisauskas, Mantas; Michaut, Lydia; Schäfer, Martin; Spindeldreher, Sebastian; Ullmann, Martin; Nana Weldingh, Karin; Kromminga, Arno; Snoeck, Veerle.
Afiliación
  • Lotz GP; Roche Pharma Research and Early Development, Roche Innovation Center Munich, Penzberg, Germany. gregor.lotz@roche.com.
  • Benstein K; Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst, Frankfurt am Main, Germany.
  • Bloem K; Biologics Lab, Sanquin Diagnostic Services, Amsterdam, The Netherlands.
  • Buddiger H; Genmab B.V., Uppsalalaan 15, Utrecht, The Netherlands.
  • Calonder C; Novartis Institutes for BioMedical Research, Basel, Switzerland.
  • Elm S; Amgen Research (Munich) GmbH, Munich, Germany.
  • Fernandez E; Roche Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.
  • Goodman J; Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences, AstraZeneca, BioPharmaceuticals R&D, Cambridge, UK.
  • Gorovits B; Sana Biotechnology, Inc., MA, Cambridge, USA.
  • Grudzinska-Goebel J; Bayer AG, Drug Metabolism & Pharmacokinetics, Berlin, Germany.
  • Janssen M; SciPot Consultancy, Amsterdam, The Netherlands.
  • Jawa V; Bristol Myers Squibb, Biotherapeutics and Bioanalysis Non-Clinical Development, Princeton, New Jersey, USA.
  • Kramer D; Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst, Frankfurt am Main, Germany.
  • Luo L; Regulated BA, Merck & Co., Inc., Kenilworth, New Jersey, USA.
  • Malisauskas M; Merck KGaA, Darmstadt, Germany.
  • Michaut L; Integrated Biologix, Basel, Switzerland.
  • Schäfer M; Roche Pharma Research and Early Development, Roche Innovation Center Munich, Penzberg, Germany.
  • Spindeldreher S; Integrated Biologix, Basel, Switzerland.
  • Ullmann M; Fresenius Kabi, Eysins, Switzerland.
  • Nana Weldingh K; Novo Nordisk, Non-clinical & Clinical Assay Sciences, Maaloev, Denmark.
  • Kromminga A; Kromminga Consulting, Hamburg, Germany.
  • Snoeck V; Institute for Immunology, Kiel, Germany.
AAPS J ; 24(3): 68, 2022 05 12.
Article en En | MEDLINE | ID: mdl-35554731
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Anticuerpos Tipo de estudio: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2022 Tipo del documento: Article País de afiliación: Alemania
Texto completo
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Anticuerpos Tipo de estudio: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2022 Tipo del documento: Article País de afiliación: Alemania