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。
本文採 Schall (1995)所建議的判定準則來作為評估一種學名藥與原廠藥是否具有個體生體相等性的依據。內容重點為透過模擬(simulation)實驗的方式，對判定藥物為個體生體相等性的檢定力(power)作一評比，研究的項目有：(1)檢定力在不同交叉實驗設計(crossover design)下表現的異同；(2)檢定力在不同參數組合情況下表現的趨勢；(3)樣本數(sample size)對檢定力的影響。 / 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.
| Identifer | oai:union.ndltd.org:CHENGCHI/B2002002096 |
| Creators | 董雅萍 |
| Publisher | 國立政治大學 |
| Source Sets | National Chengchi University Libraries |
| Language | 中文 |
| Detected Language | English |
| Type | text |
| Rights | Copyright © nccu library on behalf of the copyright holders |
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