Title

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.

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

Peer Reviewed

1

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