Structured Risk Assessment for First-in-Human Studies

被引:0
|
作者
Mattheus Thijs van Iersel
Howard E. Greenberg
Mary L. Westrick
机构
[1] PRA Health Sciences,Early Development Services
[2] Janssen Research and Development,undefined
[3] LLC,undefined
[4] University of Wisconsin-Madison,undefined
来源
Therapeutic Innovation & Regulatory Science | 2017年 / 51卷
关键词
safety; first-in-human; phase 1; risk assessment; risk mitigation;
D O I
暂无
中图分类号
学科分类号
摘要
We describe a structured risk assessment and risk mitigation process that is currently used to evaluate proposed first-in human (FiH) studies. This process balances the inherent risks of an FiH study with maximal protection of subjects. Risk assessment should consider all available data, carefully identifying aspects that may lead to risk for healthy subjects. A structured risk assessment avoids omissions and promotes consistency. Such a risk assessment should be performed for Investigational Products as well as for challenge agents and study procedures. Careful risk assessment recognizes gaps of knowledge and emphasizes that FiH studies are tolerability, not toxicity, studies.
引用
收藏
页码:288 / 297
页数:9
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