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Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015-2020

Samuels, S; Park, K; Bhatt-Mehta, V; Sun, HH; Mulugeta, Y; Yao, L; Green, DJ; Burckart, GJ

Burckart, GJ (通讯作者),US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Bldg 51 Rm 3184,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.

JOURNAL OF CLINICAL PHARMACOLOGY, 2023; 63 (3): 307

Abstract

Pediatric extrapolation plays a key role in the availability of reliable pediatric use information in approved drug labeling. This review examined the......

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