| dc.contributor.advisor | 林慧 | zh_TW |
| dc.contributor.author (作者) | 方廷企 | zh_TW |
| dc.creator (作者) | 方廷企 | zh_TW |
| dc.date (日期) | 1997 | en_US |
| dc.date.accessioned | 27-四月-2016 11:24:19 (UTC+8) | - |
| dc.date.available | 27-四月-2016 11:24:19 (UTC+8) | - |
| dc.date.issued (上傳時間) | 27-四月-2016 11:24:19 (UTC+8) | - |
| dc.identifier (其他 識別碼) | B2002002098 | en_US |
| dc.identifier.uri (URI) | http://nccur.lib.nccu.edu.tw/handle/140.119/86503 | - |
| dc.description (描述) | 碩士 | zh_TW |
| dc.description (描述) | 國立政治大學 | zh_TW |
| dc.description (描述) | 統計學系 | zh_TW |
| dc.description (描述) | 85354010 | zh_TW |
| dc.description.abstract (摘要) | 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。 | zh_TW |
| dc.description.abstract (摘要) | 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. | en_US |
| dc.description.tableofcontents | ABSTRACT 11. INTRODUCTION 22. DESIGNS FOR DOSE RESPONSE STUDY 52.1 Parallel Design 52.2 Crossover Design 53. THE CLASSICAL METHOD 73.1 The Classical Method for Assessment of Dose Linearity 73.2 The Classical Method for Assessment of Dose Response Curve 84. THE SLOPE METHOD 104.1 The Proposed Method for the Assessment of Dose Linearity 104.1.1 Approach 1 104.1.2 Approach 2 114.1.3 Two-Stage Test for Range of Linearity 174.2 The Assessment of Dose Response Curve 184.2.1 Test for Monotonicity of Mi`s 184.2.2 Multiple Test Procedures 214.2.3 Closed Test Procedure Using Global Test (CTPG) 234.2.4 Adjacent Doses (CTPB) 235. EXAMPLES OF DOSE RESPONSE CHARACTERIZATION 235.1 An Example for Approach 1 255.2 An Example for Approach 2 266. DISCUSSION 30REFERENCES 32APPENDIXI 35 | zh_TW |
| dc.source.uri (資料來源) | http://thesis.lib.nccu.edu.tw/record/#B2002002098 | en_US |
| dc.subject (關鍵詞) | 藥物劑量 | zh_TW |
| dc.subject (關鍵詞) | 線性關係 | zh_TW |
| dc.subject (關鍵詞) | 非線性關係 | zh_TW |
| dc.subject (關鍵詞) | 無母數 | zh_TW |
| dc.subject (關鍵詞) | 一般線性模式 | zh_TW |
| dc.subject (關鍵詞) | 交叉實驗 | zh_TW |
| dc.subject (關鍵詞) | Linearity | en_US |
| dc.subject (關鍵詞) | Nonlearity | en_US |
| dc.subject (關鍵詞) | Nonparametric | en_US |
| dc.subject (關鍵詞) | General linear model | en_US |
| dc.subject (關鍵詞) | Crossover | en_US |
| dc.subject (關鍵詞) | Dose Response | en_US |
| dc.title (題名) | 臨床實驗藥量特性之研究 | zh_TW |
| dc.title (題名) | Characterizing dose response curve in clincal trials | en_US |
| dc.type (資料類型) | thesis | en_US |
