Biotherapeutics in non-clinical development: Strengthening the interface between safety, pharmacokinetics-pharmacodynamics and manufacturing

Article ID	Journal	Published Year	Pages	File Type
8551517	Regulatory Toxicology and Pharmacology	2018	10 Pages	PDF

Abstract

(iv) Safety Assessment of Combination Products for Non-oncology

Keywords

NHP Non-clinical safety TNF FDA PKPD ATMP MRD NOAEL MABEL FcRn CRS TCr CQA EMA CMC mAb FIM Monoclonal antibody European Medicines agency first-in-human First-in-man Immunogenicity immunoglobulin interferon IFN interleukin Biotherapeutics cluster of differentiation Intravenous Advanced therapy medicinal products subcutaneous Food and Drug Administration Cytokine Release Syndrome FIH Pharmacokinetics Pharmacokinetics/pharmacodynamics tumor necrosis factor CAR ICH No observed adverse effect level Critical Quality Attributes Non-human primates International Conference on Harmonization neonatal Fc receptor chimeric antigen receptor T cell receptor Fc gamma receptor

Related Topics

Life Sciences Environmental Science Health, Toxicology and Mutagenesis

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Biotherapeutics in non-clinical development: Strengthening the interface between safety, pharmacokinetics-pharmacodynamics and manufacturing

Authors

Peter Ulrich, Guenter Blaich, Andreas Baumann, Rajni Fagg, Adam Hey, Andrea Kiessling, Sven Kronenberg, Rikke Hvid Lindecrona, Silke Mohl, Wolfgang F. Richter, Jay Tibbitts, Flavio Crameri, Lucinda Weir,