Non-human primates in the PKPD evaluation of biologics: Needs and options to reduce, refine, and replace. A BioSafe White Paper.

Ménochet, Karelle; Yu, Hongbin; Wang, Bonnie; Tibbitts, Jay; Hsu, Cheng-Pang; Kamath, Amrita V; Richter, Wolfgang F; Baumann, Andreas

Ménochet, Karelle; Yu, Hongbin; Wang, Bonnie; Tibbitts, Jay; Hsu, Cheng-Pang; Kamath, Amrita V; Richter, Wolfgang F; Baumann, Andreas.

Afiliação

Ménochet K; Quantitative Discovery and Development, UCB, Slough, UK.
Yu H; R&D Project Management and Development Strategies, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA.
Wang B; Nonclinical Disposition and Bioanalysis, Bristol Myers Squibb, Inc, Princeton, NJ, USA.
Tibbitts J; Nonclinical Development, South San Francisco, CA, USA.
Hsu CP; Preclinical Development and Clinical Pharmacology, AskGene Pharma Inc, Camarillo, CA, USA.
Kamath AV; Preclinical and Translational Pharmacokinetics and Pharmacodynamics, Genentech Inc, South San Francisco, CA, USA.
Richter WF; Roche Pharma Research and Early Development, Roche Innovation, Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Baumann A; R&D, Bayer Pharma AG, Berlin, Germany & Non-clinical Biotech Consulting, Potsdam, Germany °(° present affiliation).

MAbs ; 14(1): 2145997, 2022.

Article em En | MEDLINE | ID: mdl-36418217

Assuntos

Produtos Biológicos; Animais; Humanos; Produtos Biológicos/farmacologia; Primatas; Anticorpos Monoclonais

Palavras-chave

3Rs; Non-human primate; Pharmacokinetics/Pharmacodynamics; Target-mediated drug disposition; antibodies; dose prediction; immunogenicity; nonspecific clearance; pharmacokinetics; translation

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos Tipo de estudo: Prognostic_studies Limite: Animals / Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

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