Neonatal Safety Information Reported to the FDA During Drug Development Studies

被引：0
作者：
Debbie Avant
Gerri Baer
Jason Moore
Panli Zheng
Alfred Sorbello
Ron Ariagno
Lynne Yao
Gilbert J. Burckart
Jian Wang
机构：
[1] US Food and Drug Administration,Office of Pediatric Therapeutics, Office of the Commissioner
[2] US Food and Drug Administration,Office of Clinical Pharmacology, Center for Drug Evaluation and Research (CDER)
[3] Thomas Jefferson University,Department of Pharmacology and Experimental Therapeutics
[4] University of North Carolina School of Pharmacy,Office of Translational Sciences
[5] US Food and Drug Administration,Division of Pediatric and Maternal Health, Office of New Drugs, CDER
[6] Stanford University School of Medicine,Office of Drug Evaluation IV, CDER
[7] US Food and Drug Administration,undefined
[8] US Food and Drug Administration,undefined
来源：
Therapeutic Innovation & Regulatory Science | 2018年 / 52卷
关键词：
neonates; serious adverse events; drug development; safety; US FDA;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
引用
收藏
页码：100 / 108
页数：8
相关论文
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