201507 FDA行业指南：分析方法验证（中英文）（下）mayday什么意思>英国金融时报
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unfccc VII. STATISTICAL ANALYSIS AND MODELS 统计学分析和模型A. Statistics 统计学Statistical analysis of validation data can be ud to evaluate validation characteristics against predetermined acceptance criteria. All statistical procedures and parameters ud in the analysis of the data should be bad on sound principles and appropriate for the intended evaluation. Several statistical methods are uful for asssing validation characteristics, for example, an analysis of variance (ANOVA) to asss regression analysis R (correlation coefficient) and R squared (coefficient of determination) or linear regression to measure linearity. Many statistical methods ud for asssing validation characteristics rely on population normality, and it is important to determine whether or not to reject this assumption. There are many techniques, such as histograms, normality tests, and probability plots that can be ud to evaluate the obrved distribution. It may be appropriate to transform the data to better fit the normal distribution or apply distribution-free (nonparametric) approaches when the obrved data are not normally distributed. Appropriate literature or text should be consulted for information on statistical procedures to 马丁路德金纪念日>holloway
出国留学申请流程u when developing new test methods, evaluating existing test methods or evaluating measurement system performance, as well as other general information on the interpretation and treatment of analytical data[18].The data analysis should be assured either by using appropriately validated software or independent verification for correctness.验证数据的统计学分析可以用于评估验证的属性是否符合预定的可接受标准。所有用于数据分析的统计学程序和参数均应是基于合理的原则，并适合于既定评估。有几个统计学方法用于评估验证属性颇为有用，例如，变量分析（ANOVA）用于评估相关性分析R（相关因子）和R平方（判定系数或拟合优度）或线性回归用于测量线性。许多用于评估验证属性的统计学方法依赖于样本的正态性，决定是否拒绝该假设很重要。有许多技术，如柱状图、正态分布和概率图，可以用于评估所观察到的分布情况。如果观察到的数据是非正态分布的，则将数据转换成为更为正态分布或应用非正态分布（无参数）方法会更为恰当。在研发新的分析方法、评估现有分析方法、或评估测量系统性能时，应参考适当的文献或文件来获取关于统计学程序的信息，以及关于分析数据诠释和处理的其它通用信息。数据分析应采用经过适当验证的软件，否则应单独确认其正确性。B. Models 模型
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