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政大機構典藏 > 商學院 > 統計學系 > 學位論文 > Item 140.119/86501

Please use this identifier to cite or link to this item: https://nccur.lib.nccu.edu.tw/handle/140.119/86501

Title:	在不同實驗設計下藥物個體生體相等性檢定力之比較
Authors:	董雅萍
Contributors:	江振東董雅萍
Keywords:	生體可用相對值平均生體相等性個體生體相等性檢定力交叉實驗設計樣本數 Average bioequivalence Individual bioequivalence Power Coverage probability
Date:	1997
Issue Date:	2016-04-27 11:24:15 (UTC+8)
Abstract:	傳統上，判定一種學名藥(generic drug)與原廠藥(innovator drug)是否具有生體相等性所常用的統計方法為：比較兩種藥物的生體可用相對值(relative bioavailability)的母體平均數是否相等，此即所謂的平均生體相等性(average bioequivalence)。然而就兩種藥物可互用的觀點而言，似乎更需要考慮的是每位受測個體在服用藥物後，不同藥物在個體內反應的差異性，因此 Anderson and Hauck (1990)提出個體生體相等性(individual bioequivalence)的觀點。 Conventionally, that a generic drug and an innovator drug are regarded as having the same treatment effects is based on the concept of average bioequivalence,i.e., that average responses between individuals on the two formulations are similar. Anderson and Hauck (1990) argued that it was not sufficient to expect that an individual patient would response similarly to the two formulations. The thought has received a lot of attention lately, and quite a few methods have been proposed to deal with the issue of the individual bioequivalence. According to the "unified" approach proposes by Schall (1995), a simulation study on power to declare bioequivalence and coverage probability of confidence intervals is carried out here to compare their performance under different experimental designs.
Description:	碩士國立政治大學統計學系 85354012
Source URI:	http://thesis.lib.nccu.edu.tw/record/#B2002002096
Data Type:	thesis
Appears in Collections:	[統計學系] 學位論文

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