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.

Authors

Xiaomei I Liu
André Dallmann
Yow-Ming Wang
Dionna J Green
Janelle M Burnham
Beatrice Chiang
Perry Wu
Mark Sheng
Kelley Lu
John N. van den Anker, George Washington University
Gilbert J Burckart

Document Type

Journal Article

Publication Date

8-1-2019

Journal

Journal of Clinical Pharmacology

Volume

59

Issue

8

Inclusive Pages

1130-1143

DOI

10.1002/jcph.1406

Keywords

Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Biological Products; Child; Computer Simulation; Drug Approval; Humans; Middle Aged; Models, Biological; Receptors, Fc; Recombinant Fusion Proteins; United States; United States Food and Drug Administration; Young Adult

Comments

Epub 2019 Mar 13

APA Citation

Liu, X., Dallmann, A., Wang, Y., Green, D., Burnham, J., Chiang, B., Wu, P., Sheng, M., Lu, K., van den Anker, J. N., & Burckart, G. (2019). 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.. Journal of Clinical Pharmacology, 59 (8). http://dx.doi.org/10.1002/jcph.1406

Peer Reviewed

1