摘要
本文提出新药临床试验中最常用的2周期交叉设计分析法。在病人内比较药物差别;检验药物的周期效应与药物-周期交互作用,前者可分析病人反应是否有与药物无关的自然变迁,后者可分析药物有无后遗效应。
A two-period cross-over design in new clinical trials is proposed. By the design the within-patient comparisons between drugs and between periods can be made. The tests of period-effect and drug-period interaction may explain whether the spontaneous changes of effect of periods and the carry-over effect of drugs exist respectively.
出处
《新药与临床》
CSCD
北大核心
1993年第2期88-90,共3页
关键词
临床试验
统计学
新药
clinical trial
statistics
cross-over design
interaction
carry-over effect