Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials

被引：14

作者：

Davis, Jonathan M. ^{[1
,2
]}

Baer, Gerri R. ^{[3
]}

McCune, Susan ^{[3
]}

Klein, Agnes ^{[4
]}

Sato, Junko ^{[5
]}

Fabbri, Laura ^{[6
]}

Mangili, Alexandra ^{[7
]}

Short, Mary A. ^{[8
]}

Tansey, Susan ^{[9
]}

Mangum, Barry ^{[10
]}

Hokuto, Isamu ^{[11
]}

Nakamura, Hidefumi ^{[12
]}

Salaets, Thomas ^{[13
]}

Allegaert, Karel ^{[13
,14
]}

Yao, Lynne ^{[15
]}

Blum, Michael ^{[15
]}

Toerner, Joseph ^{[15
]}

Turner, Mark ^{[16
]}

Portman, Ron ^{[17
]}

机构：

[1] Tufts Med Ctr, Floating Hosp Children, 800 Washington St, Boston, MA 02111 USA

[2] Tufts Clin & Translat Sci Inst, Boston, MA USA

[3] US FDA, Off Pediat Therapeut, Silver Spring, MD USA

[4] Hlth Canada, Ottawa, ON, Canada

[5] Pharmaceut & Med Devices Agcy, Tokyo, Japan

[6] Chiesi Farmaceutici SpA, Parma, Italy

[7] Takeda Pharmaceut Co Ltd, Zug, Switzerland

[8] Eli Lilly & Co, Indianapolis, IN 46285 USA

[9] Independent Consultant Pharmaceut Phys, Durham, NC USA

[10] Paidion Res Inc, Durham, NC USA

[11] St Marianna Univ, Kawasaki, Kanagawa, Japan

[12] Natl Ctr Child Hlth & Dev, Tokyo, Japan

[13] Katholieke Univ Leuven, Dept Dev & Regenerat, Leuven, Belgium

[14] Sophia Childrens Univ Hosp, Erasmus MC, Div Neonatol, Dept Pediat, Rotterdam, Netherlands

[15] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[16] Univ Liverpool, Inst Translat Med, Liverpool, Merseyside, England

[17] Novartis Pharmaceut, E Hanover, NJ USA

[18] Crit Path Inst, Tucson, AZ USA

来源：

JOURNAL OF PEDIATRICS | 2020年 / 219卷

关键词：

QUALITY;

D O I：

10.1016/j.jpeds.2019.09.060

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

引用

页码：243 / +

页数：8

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