生物活性检测方法验证统计分析软件的设计和功能  

Design and function of statistical software for validation of biological methods

作　　者：韩璐 隋思涟[2] 谭德讲[1] 段丽 李娜[1] 杜颖 施瑞红 HAN Lu;SUI Si-lian;TAN De-jiang;DUAN Li;LI Na;DU Ying;SHI Rui-Hong(NMPA Key Lab for Quality Research and Evaluaion of Chemical Drug,National Institutes for Food and Drug Control,Beijing 102629.China;Qingdao University of Technology,Qingdao 266033,China)

机构地区：[1]中国食品药品检定研究院国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629 [2]青岛理工大学,青岛266033

出　　处：《药物分析杂志》2022年第6期979-987,共9页Chinese Journal of Pharmaceutical Analysis

基　　金：国家药品标准制修订课题(2022Y09);中检院质量安全与能力建设项目。

摘　　要：生物活性检测方法验证(biological method validation, BMV)统计分析软件是一款具有全部自主产权的专用统计分析软件。其优势在于:(1)提供常见的方法验证性能参数,如精密度及其置信上限、准确度及其相应的置信区间、范围等;(2)提供满足方法需求的判定标准,如分析总误差、报告值的预测区间、容忍区间、方法能力指数(MCI)等;(3)新增方法应用指标,包括操作模式变异度、报告值的区分阈值、能力验证标准差、方法关键影响因素分析等;(4)为使用者提供自主选择生物实验系统适用性模型,并可计算验证实验所需样本量。此软件不仅操作简便,而且输出结果科学可靠,可满足各国药典或指南对方法验证的要求。该软件的开发,将方便于药品行业研发人员建立科学可靠的生物活性检测方法,以确保药品的质量安全。Biological method validation(BMV) is a proprietary statistical analysis software for the validation of biological methods and has many advantages.(1) Common performance parameters of bioassay, such as precision value and its upper confidence limit, accuracy value and its corresponding confidence interval and range are provided.(2) Criteria to meet the requirements of the methods, such as total analytical error(TAE), prediction interval and tolerance interval of reportable value, method capability index(MCI) are provided.(3) Some new method application indicators, such as format variability(FV), difference threshold of reportable value, standard deviation of proficiency assessment, and analysis of critical factors of the method are included.(4) It provides applicable model of self-selected biological experiment system, and calculates the sample size required to verify theexperiment. The software is easy to use and the output results are accuracy and reliable, which can meet the requirements of the current pharmacopoeia or guidelines of various countries. The development of this software will facilitate drug industry researchers to establish more scientific and reliable biological methods to ensure the quality and safety of drugs.

关 键 词：生物活性检测方法验证(BMV) 统计分析软件 方法性能参数 分析总误差 报告值的预测区间 报告值的容忍区间 方法能力指数 操作模式变异度 报告值的区分阈值 能力验证标准差 方法关键影响因素分析 样本量 

分 类 号：R917[医药卫生—药物分析学]