目的: 系统阐述关于方法能力的评估指标及其标准,为科学、多角度地评估方法能力提供参考。方法: 结合生物活性检测方法验证特点,从各指标的定义、计算公式、用途及意义入手,论述5种新评估方法满足预期用途的能力指标及其判定标准。结果: 用来判断方法满足预期用途的新方法能力指标有:(1)方法的总分析误差(TAE);(2)报告值的预测区间(RVPI)和容忍区间(RVTI);(3)方法能力指数(MCI)和方法误判率(MMJP)。5个指标从不同角度提供了方法能力的量化评估,为药品开发者和监管者衡量方法能力提供更直观的评估指标。结论: 利用严谨的方法验证获得的实验数据集和统计技术,可以获得更多直接并易于理解的方法能力评估指标;这些指标不仅丰富方法的属性集,而且可对方法有更深入的理解。
Objective: To elaborate systematically the evaluation indexes and acceptance criteria of method capabilitys and provide a reference for scientific and multi-perspective assessments of method capability. Methods: The capability assessment indexes and their acceptance criteria were discussed for satisfying its intended use by starting with the definition, calculation formula, use and meaning of each index, combined with the validation characteristics of bioassay. Results: The new developed method capability assessment indexes for judging whether the method meets the intended use included(1) total analytical error of analytical procedure (TAE); (2) Prediction interval (RVPI) and tolerance interval (RVTI) of reportable values; (3) Method capability index (MCI) and misjudgment probability of method (MMJP). The five indexes were provided for evaluating capability assessment of method quantitatively from different perspectives and could be more intuitive, for drug developers and regulators to evaluate the method capability. Conclusion: More directly related and easy-to-understand indexes for method capability assessment could be obtained by usin g precise validation dataset of method and statistical techniques, and the capability assessment indexes of the new methods could enrich the attribute set of the method, and also help us to have a more in-depth understan ding of it.
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