方法验证性能参数的获取和评价方式再探讨

综述了目前国内外方法验证的法规和/或指导原则中对于方法性能参数进行验证和评价的统计学方法；并对如何通过风险分析、实验设计、样本量和结果计算以获得更可靠性能参数等方面的问题进行了探讨。

The statistical methods for validation and evaluation of performance parameters of analytical procedures in domestic and foreign regulations and/or guidelines were summarized. The issues to obtain more reliable performance parameters by risk analysis, experimental design, sample size calculation, and results calculation evaluation were also discussed.

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