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5.1 This practice can be used to determine if a constant, proportional, or linear bias correction can improve the degree of agreement between two methods that purport to measure the same property of a material.
5.2 The bias correction developed in this practice can be applied to a single result (X) obtained from one test method (method X) to obtain a predicted result ( Y^) for the other test method (method Y).
Note 6: Users are cautioned to ensure that Y^ is within the scope of method Y before its use.
5.3 The between methods reproducibility established by this practice can be used to construct an interval around Y^ that would contain the result of test method Y, if it were conducted, with about 958201;% confidence.
5.4 This practice can be used to guide commercial agreements and product disposition decisions involving test methods that have been evaluated relative to each other in accordance with this practice.
5.5 The magnitude of a statistically detectable bias is directly related to the uncertainties of the statistics from the experimental study. These uncertainties are related to both the size of the data set and the precision of the processes being studied. A large data set, or, highly precise test method(s), or both, can reduce the uncertainties of experimental statistics to the point where the “statistically detectable” bias can become “trivially small,” or be considered of no practical consequence in the intended use of the test method under study. Therefore, users of this practice are advised to determine in advance as to the magnitude of bias correction below which they would consider it to be unnecessary, or, of no practical concern for the intended application prior to execution of this practice.
Note 7: It should be noted that the determination of this minimum bias of no practical concern is not a statistical decision, but rather, a subjective decision that is directly dependent on the application require...... 而劣質藥品，可能只在一種體內環境下（如胃酸正常者）才有一定的溶出和吸收，而在其他體內環境下可能崩解、溶出就會很差，生物利用度也就很低。比如，我們對某種試劑在不同轉速下的溶出度進行測量，基于不同的溶出度曲線，對比不同人群對于該試劑不同的生物利用度，找出溶出度同生物利用度之間的關聯性，就能快速的進行仿制藥藥學一致性的評價了。?... 而劣質藥品，可能只在一種體內環境下（如胃酸正常者）才有一定的溶出和吸收，而在其他體內環境下可能崩解、溶出就會很差，生物利用度也就很低。比如，我們對某種試劑在不同轉速下的溶出度進行測量，基于不同的溶出度曲線，對比不同人群對于該試劑不同的生物利用度，找出溶出度同生物利用度之間的關聯性，就能快速的進行仿制藥藥學一致性的評價了。... 這兩種原料都用于香水和化妝品行業。為了顯示試驗的分散性和重復性，將表2所列精油和香料的閃點結果分為三份進行測定。結果如表3所示，列出了一系列“無閃點”的結果，主要是因為手霜、身體霜、化妝品行業使用的其他添加劑和原材料的含水量相當大。表3還比較了兩種不同類型的測量結果：快速掃描(SCAN)和ASTM D7094。根據ASTM D7094測量閃點，需要知道預期閃點。... 計算h值大于2.63的測量值被當做異常值排除（2.63這個值是來自于28個分析人員根據經驗得出的）。ASTM將重復性定義為同一操作人員在短時間間隔內使用相同的設備，在同一實驗室用相同的方法對相同的試驗項目獲得獨立的試驗結果。在不同的實驗室，不同的操作人員使用不同的設備，以相同的方法對相同的測試項目獲得測試結果的情況下，ASTM將再現性定義為精度。...他山石 | 仿藥巨頭TEVA的藥品一致性秘訣
食品、香精、香料的閃點測定 ——ERAFLASH?保證產品質量和運輸安全的重要可靠工具
分散有機物反射率測量的標準化
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