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政大典藏 > College of Commerce > Department of Statistics > Theses > Item 140.119/86503

Please use this identifier to cite or link to this item: https://nccur.lib.nccu.edu.tw/handle/140.119/86503

Title:	臨床實驗藥量特性之研究 Characterizing dose response curve in clincal trials
Authors:	方廷企
Contributors:	林慧方廷企
Keywords:	藥物劑量線性關係非線性關係無母數一般線性模式交叉實驗 Linearity Nonlearity Nonparametric General linear model Crossover Dose Response
Date:	1997
Issue Date:	2016-04-27 11:24:19 (UTC+8)
Abstract:	在製藥工業中，藥量特性之研究常被應用於藥理學、毒物學及臨床試驗中。藥量特性之研究同時在臨床試驗中的第一階段的藥物安全性及第二階段的藥物有效性中扮演著重要的角色。透過藥量特性的研究，使我們對於藥物的開發有著更深一層的認識，並可藉此縮短藥物核准上市的時間。　　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 varibility 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 asses 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.
Description:	碩士國立政治大學統計學系 85354010
Source URI:	http://thesis.lib.nccu.edu.tw/record/#B2002002098
Data Type:	thesis
Appears in Collections:	[Department of Statistics] Theses

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