科学的实验设计是保证检测方法的结果准确性和结论可靠性的主要工具。本文对影响因素多且变异大的生物活性检测方法验证所需的实验设计进行了探讨,并详细阐述了在方法验证设计中样本量的计算方法。希望今后能为生物活性检测方法验证人员准确理解方法验证实验设计提供理论参考。
Scientific design of experiment (DOE) is the main tool to ensure the accuracy of test results and the reliability of conclusions. It is discussed the validation design for bioassay with many influencing factors and great variation, and the calculation method of sample size in method validation design is elaborated in detail here. It is hoped that it could provide theoretical reference for bioassay valiadation to accurately understand the experimental design of method validation.
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