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Challenges of non-clinical safety testing for biologics: A Report of the 9th BioSafe European Annual General Membership Meeting.
Kissner, Thomas; Blaich, Guenter; Baumann, Andreas; Kronenberg, Sven; Hey, Adam; Kiessling, Andrea; Schmitt, Petra M; Driessen, Wouter; Carrez, Chantal; Kramer, Daniel; Fretland, Jennifer; Richter, Wolfgang F; Paehler, Tobias; Hopfer, Ulrike; Rattel, Benno.
Afiliação
  • Kissner T; Preclinical Safety, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
  • Blaich G; Preclinical Safety, AbbVie Deutschland GmbH, Ludwigshafen, Germany.
  • Baumann A; R&D Pharmaceuticals, Translational Sciences, Bayer AG, Berlin, Germany.
  • Kronenberg S; Pharmaceutical Sciences, Pharma Research and Early Development (pRED), Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Hey A; Oncology Safety, Clinical Pharmacology and Safety Sciences, AstraZeneca, Cambridge, UK.
  • Kiessling A; Preclinical Safety, Novartis Pharma, Basel, Switzerland.
  • Schmitt PM; Preclinical Safety, AbbVie Deutschland GmbH, Ludwigshafen, Germany.
  • Driessen W; Pharmaceutical Sciences, Pharma Research and Early Development (pRED), Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Carrez C; Sanofi R&D, Translational In Vivo Models, Sanofi S.A, Vitry-sur-Seine, France.
  • Kramer D; Sanofi R&D, Translational Medicine & Early Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
  • Fretland J; Drug Metabolism and Pharmacokinetics, Sanofi US, Waltham, MA, USA.
  • Richter WF; Pharmaceutical Sciences, Pharma Research and Early Development (pRED), Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Paehler T; Drug Metabolism and Pharmacokinetics, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
  • Hopfer U; Pharmaceutical Sciences, Pharma Research and Early Development (pRED), Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Rattel B; Translational Safety & Bioanalytical Sciences, Amgen Research (Munich) GmbH, Munich, Germany.
MAbs ; 13(1): 1938796, 2021.
Article em En | MEDLINE | ID: mdl-34241561
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Avaliação Pré-Clínica de Medicamentos Limite: Humans Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
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XML
PubMed Links
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Avaliação Pré-Clínica de Medicamentos Limite: Humans Idioma: En Ano de publicação: 2021 Tipo de documento: Article