Monoclonal Antibodies and Fc‐Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration - Liu, Xiaomei I.; Dallmann, André; Wang, Yow‐Ming; Green, Dionna J.; Burnham, Janelle M.; Chiang, Beatrice; Wu, Perry; Sheng, Mark; Lu, Kelley; Anker, John N.; Burckart, Gilbert J. (Journal of clinical pharmacology, 2019)
Keywords: dosing; drug development; Fc‐fusion proteins; immunogenicity; modeling and simulation; monoclonal antibodies; pediatrics; modeling and simulation; pediatrics; drug development; Fc-fusion proteins; dosing; immunogenicity; monoclonal antibodies