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篇名 A Procedure for Weight and Model Selection in Assay Development
卷期 4:1
並列篇名 化驗方法發展中模型與權數之選取
作者 林慧周賢忠
頁次 001-012
關鍵字 Calibrationstandard curveassay validationweight selectionmodel selection儀器刻劃標準曲線化驗確認變異MEDLINEScopusSCIE
出刊日期 199603

中文摘要

本文考慮T在化驗開發時(assay development ), 儀器刻劃 ( calibration ) 的過程中 ,對 標準曲線(standard curve )模型與權數 (weight)的選取。通常儀器的刻劃是藉由研究 已知標準與其反應值(response)的關係。而 這兩者間的關係又常籍由標準曲線來描述。經 由標準曲線,我們可以決定未知樣本。由於在 不同已知標準的反應値可能有不同的變異(variability),且標準與其應對之反應値可能呈 現非線性的關係,因此如何選擇建立標準曲線 合適的模型及權數,以獲得準確的化驗結果實 為重要之課題。在本文中,我們考慮丫五種最 常用的模型及三種可能的權數。我們提出了 -個選擇模型及權數的準則。-個確認(validate) 製藥化合物中之血漿化驗的實例將用來説明所 提出的準則。

英文摘要

The problem of weight and model selection for standard curve in the calibration of an instrument for assay development is considered. An instrument is usually calibrated by studying the relationship between a number of known standards and their corresponding responses. The relationship between known standards and their responses is usually described by a standard curve. Based on the established standard curve, an unknown sample can be determined. In practice, since the responses may have different variabilities at dift'erent known standards and the relatioship between the standards and their corresponding responses may not be linear, it is important to select an appropriate model with an appropriate weight in establishing a standard curve for obtaining an accurate and reliable assay result. In this paper, criteria for weight and model selection are proposed to choose an appropriate statistical model among five commonly used models with three dift'erent possible weights. An example concerning the validation of a plasma assay of a pharmaceutical compound is presented to illustrate the use of the proposed criteria.

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