Failed Pediatric Drug Development Trials

被引：72

作者：

Momper, J. D. ^{[1
]}

Mulugeta, Y. ^{[2
]}

Burckart, G. J. ^{[2
]}

机构：

[1] Univ Calif San Diego, Skaggs Sch Pharm & Pharmaceut Sci, La Jolla, CA 92093 USA

[2] US FDA, Off Clin Pharmacol, Off Translat Sci, Silver Spring, MD 20993 USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2015年 / 98卷 / 03期

关键词：

ADOLESCENTS; CHILDREN;

D O I：

10.1002/cpt.142

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Pediatric product development initiatives have stimulated the development of therapies for children, resulting in improved product labeling, increased identification of adverse events, and development of new pediatric formulations. However, 42% of recently completed pediatric trials have failed to establish either safety or efficacy, leading to an inability to label the product for use in children.(1) Characterizing these failed trials, including common contributing factors, is imperative to designing better pediatric trials in the future.

引用

页码：245 / 251

页数：7

共 5 条

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