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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...... 而劣质药品,可能只在一种体内环境下(如胃酸正常者)才有一定的溶出和吸收,而在其他体内环境下可能崩解、溶出就会很差,生物利用度也就很低。比如,我们对某种试剂在不同转速下的溶出度进行测量,基于不同的溶出度曲线,对比不同人群对于该试剂不同的生物利用度,找出溶出度同生物利用度之间的关联性,就能快速的进行仿制药药学一致性的评价了。 ... 而劣质药品,可能只在一种体内环境下(如胃酸正常者)才有一定的溶出和吸收,而在其他体内环境下可能崩解、溶出就会很差,生物利用度也就很低。比如,我们对某种试剂在不同转速下的溶出度进行测量,基于不同的溶出度曲线,对比不同人群对于该试剂不同的生物利用度,找出溶出度同生物利用度之间的关联性,就能快速的进行仿制药药学一致性的评价了。... 这两种原料都用于香水和化妆品行业。为了显示试验的分散性和重复性,将表2所列精油和香料的闪点结果分为三份进行测定。结果如表3所示,列出了一系列“无闪点”的结果,主要是因为手霜、身体霜、化妆品行业使用的其他添加剂和原材料的含水量相当大。表3还比较了两种不同类型的测量结果:快速扫描(SCAN)和ASTM D7094。根据ASTM D7094测量闪点,需要知道预期闪点。... 计算h值大于2.63的测量值被当做异常值排除(2.63这个值是来自于28个分析人员根据经验得出的)。ASTM将重复性定义为同一操作人员在短时间间隔内使用相同的设备,在同一实验室用相同的方法对相同的试验项目获得独立的试验结果。在不同的实验室,不同的操作人员使用不同的设备,以相同的方法对相同的测试项目获得测试结果的情况下,ASTM将再现性定义为精度。...他山石 | 仿药巨头TEVA的药品一致性秘诀
食品、香精、香料的闪点测定 ——ERAFLASH™保证产品质量和运输安全的重要可靠工具
分散有机物反射率测量的标准化
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