Ethical and safety aspects of clinical trials in neonates

被引：8
|
作者：
Choonara, Imti [1 ]
机构：
[1] Univ Nottingham, Acad Div Child Hlth, Derbyshire Childrens Hosp, Derby DE22 3DT, England
来源：
EARLY HUMAN DEVELOPMENT | 2009年 / 85卷 / 10期
关键词：
Neonate; Clinical trial; Drug toxicity; Ethics; CHLORAMPHENICOL; CHILDREN; NEWBORN;
D O I：
10.1016/j.earlhumdev.2009.08.006
中图分类号：
R71 [妇产科学];
学科分类号：
100211 ;
摘要：
Clinical trials in neonates are essential in order to provide scientific evidence in relation to the efficacy and safety of medicines. European legislation has recently been passed in order to stimulate clinical research in this area. This should hopefully result in more licensed medicines in the neonatal period. It is essential that the clinical trials are performed safely and ethically and one therefore needs to be aware of predisposing factors for drug toxicity in the neonatal period. (C) 2009 Published by Elsevier Ireland Ltd.
引用
收藏
页码：S19 / S20
页数：2
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