Model-Informed Approach Supporting Approval of Adalimumab (HUMIRA) in Pediatric Patients with Ulcerative Colitis from a Regulatory Perspective

Li, RJ; Ma, L; Kim, H; Kim, I; Hanes, L; Altepeter, T; Lee, J; Liu, J; Zhu, H; Wang, YN

Li, RJ (通讯作者),US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.

AAPS JOURNAL, 2022; 24 (4):

Abstract

On February 24, 2021, the U.S. Food and Drug Administration (FDA) approved an efficacy supplement for HUMIRA (R) (adalimumab) injection to expand the ......

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