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研究生: 楊修
Yang, Hsiu
論文名稱: 延續性效應對平均生物等效性之影響的研究
指導教授: 蔡碧紋
學位類別: 碩士
Master
系所名稱: 數學系
Department of Mathematics
論文出版年: 2019
畢業學年度: 107
語文別: 中文
論文頁數: 35
中文關鍵詞: 平均生物等效性延續性效應Westlake法貝氏法信賴區間法雙單側檢定法
DOI URL: http://doi.org/10.6345/NTNU201900903
論文種類: 學術論文
相關次數: 點閱:90下載:14
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  • 生物等效性試驗是指用生物利用度研究的方法,以藥物動力參數為指標,比較兩種藥物在相同的試驗條件下,其活性成分在人體中吸收程度和速度是否存在統計學差異。本文研究目的是探討在兩週期交叉試驗設計生物等效性研究,相對延續性效應和變異係數對平均生物等效性判定的影響。其中我們以模擬分析四種常見的判定方法:Westlake 方法 ,貝氏法,信賴區間法, 雙單側檢定法。在當兩種藥物具有平均生物等效性和不具有平均生物等效性的情況下,分析在不同樣本數,不同相對性延續性效應和變異係數下這四種方法的生物等效性聲明百分比的變化。

    1 緒論 1 2 交叉設計及模型和4個方法 4 2.1 交叉設計 4 2.2 模型 4 2.3 四個評價平均生物等效性的方法 7 2.3.1 Westlake法 7 2.3.2 貝氏法(Bayesian) 10 2.3.3 信賴區間法(Confidence interval,CI) 11 2.3.4 雙單側檢定法(Two one side test,TOST) 12 2.4 範例 13 3 模擬及結果 16 3.1 結果 19 3.2 討論 31 4 結論 32 5 文獻資料 34

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