Ⅰ期临床试验设计和需要重视的问题  

Phase Ⅰ clinical trial design and the problems need to focus

作　　者：钱薇[1] 肖大伟[1] 

机构地区：[1]南京大学医学院附属鼓楼医院Ⅰ期临床试验研究室

出　　处：《中国临床药理学与治疗学》2013年第6期654-660,共7页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：Ⅰ期临床试验,特别是首次人类药物试验(First in human,FIH)具有极大的挑战性。在国外,试验设计方面近年来取得了很大进展。本文就Ⅰ期临床试验设计的技术、首剂量、安慰剂对照、剂量推升方案、终止标准和风险评估进行探讨。Phase Ⅰ clinical trials, especially the first in human trials（FIH）of drugs are with greatly challenging.There are many great progress in design technology abroad.The starting dose, placebo-controlled,increasing doses,the trail termination criteria and risk assessment involved in the Phase Ⅰ clinical trial were reviewed in this article.

关 键 词：Ⅰ期临床试验 首次人类试验 试验方案设计 风险评估 

分 类 号：R969[医药卫生—药理学]