摘要
生物利用度研究中,对双交叉设计试验,已有成熟的等效性分析的统计方法,包括双单侧t检验法、可信区间法等。近年来,新药生物利用度研究中不时遇到采用多交叉设计的情形。为了判定试验制剂与参比制剂之间的等效性,双交叉设计中使用的方法难以满足要求,需借助专用于多交叉设计的生物等效性统计分析方法。本文将介绍一种适合于多交叉设计生物等效性分析的可信区间方法,结合一个实例详细给出不进行对数转换和进行对数转换时的不同处理技术,并提供了用SAS分析的程序代码。
Two one-sided t test and confidence interval are the main methods which analyze the bioequivalence of two formulations in two cross-over trial for bioavailability. But they could not be applied for the multiple cross-over design to evaluate the bioequivalence between two of the several groups. In this paper, a method of confidence interval for multiple cross-over design to infer bioequivalence will be introduced. With a real example, the detailed computation processes for raw data and logarithmic transformation data are given respectively. Some SAS procedures are also attached.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2002年第3期219-223,共5页
The Chinese Journal of Clinical Pharmacology
关键词
交叉设计
生物利用度
生物等效性
对数转换
等效性界值
可信区间
SAS
新药
cross-over design
bioavailability
bioequivalence
logarithmic transformation
equivalence margin
confidence interval
SAS
