Summary of a Public FDA Workshop: Model Informed Drug Development Approaches for Immunogenicity Assessments.

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作者： Artur A,Belov ^[1] ; Marisabel,Rodriguez Messan ^[1] ; Osman N,Yogurtcu ^[1] ; Kimberly,Schultz ^[2] ; Kimberly,Maxfield ^[3] ; Laura,Thompson ^[1] ; Sherri,Revell ^[4] ; Yolonda,Warren-Henderson ^[4] ; Million A,Tegenge ^[2] ; Zuben E,Sauna ^[2] ; Richard A,Forshee ^[1]

作者单位： Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA. ^[1] Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA. ^[2] Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA, Silver Spring, Maryland, USA. ^[3] Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA. ^[4]

主题词人类(Humans);美国(United States);美国食品和药物管理局(United States Food and Drug Administration)

DOI 10.1002/cpt.2572

PMID 35253213

发布时间 2023-02-26

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