Characterizing Dose Response Curve in Clincal Trials

• Main Author: 方廷企
• Other Authors: 林慧
• Format: Others
• Language: zh-TW
• Published: 1998
• Online Access: http://ndltd.ncl.edu.tw/handle/12196533244872042762

碩士 === 國立政治大學 === 統計研究所 === 86 === The problem of characterizing dose response curve for a pharmacokinetic parameter over a specific dose range is considered. In many cases, it is of interest to determine dose linearity (or dose proportionality) between the pharmacokinetic parameters and dose levels. For this purpose, several classical methods based on a general linear model procedure are available. However, two difficulties commonly encountered, namely (i) heterogeneity of the variability at different dose levels and (ii) violation of the normality assumptions, often make the classical methods not applicable. To account for these problems, we propose a general nonparametric test procedure by comparing the slopes at different dose level to assess dose linearity and to characterize dose response curve. An example concerning the study of dose response of a compound based on a four-way crossover experiment is presented.