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

• Published in: Journal of clinical pharmacology Vol. 59; no. 8; pp. 1130 - 1143
• Main Authors: 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.
• Format: Journal Article
• Language: English
• Published: England 01.08.2019
• Subjects: 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

The experience with the use of monoclonal antibodies and Fc‐fusion proteins (mAb/Fc) in the pediatric population is limited. The objective of this study is to review those factors impacting the clinical efficacy and product safety of mAb/Fc products in pediatric patients during drug development. We...