化驗方法發展中模型與權數之選取   全文下載

A Procedure for Weight and Model Selection in Assay Development

本文考慮了在化驗開發時（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藉由標準曲線來描述。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值可能有不同的變異（variability），且標準與其應對之反應值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，我們考慮了五種最常用的模型及三種可能的權數。我們提出了一個選擇模型及權數的准則。一個確認（validate）製藥化合物中之血漿化驗的實例將用來說明所提出的準則。

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 different known standards and the relationship 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 different 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.