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 the experiment. 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.
[1] USP43-NF38[S].2020: 7300, 7337, 8117
[2] 陶丽新,胡良平. 如何用SAS软件正确分析生物医学科研资料X.用SAS软件实现嵌套设计和裂区设计定量资料的统计分析[J].中国医药生物技术,2010, 5(4): 310
TAO LX, HU LP. How to correctly analyze biomedical scientific research data with SAS software X. SAS software is used to classify quantitative data of nested design and split design[J].Chin Pharm Biotechnol,2010,5(4):310
[3] USP <1220> Analytical Procedure Life Cycle[S/OL]. (2022-05-14) [2022-05-16]. 2022. DOI: https://doi.org/10.31003/USPNF_M10975_02_01
[4] 谭德讲,隋思涟,朱容蝶,等.理化方法验证统计分析软件的设计与功能[J].药物分析杂志,2019,39(2):224
TAN DJ, SUI SL, ZHU RD, et al. Design and function of statistical software for validation of analytical procedures[J].Chin J Pharm Anal,2019,39(2):224
[5] 中华人民共和国药典2020年版.四部[S].2020:530
ChP 2020.Vol Ⅳ[S].2020:530
[6] ISO 13528-2015. Statistical methods for use in proficiency testing by interlaboratory comparison[S].2015
[7] ASTM E1488-12. Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods[S].2018
[8] 谭德讲,朱容蝶,耿颖,等. 判断定量类理化分析方法满足预期用途的标准探讨[J].药物分析杂志,2019, 39(2):198
TAN DJ, ZHU RD, GENG Y, et al. Discussion about the criteria of quantitative physicochemical analytical methods for satisfying their intended use[J].Chin J Pharm Anal, 2019, 39(2): 198
[9] 段丽,韩璐,杜颖,等. 方法验证数据集的应用探讨[J].药物分析杂志, 2022, 42(6):972
DUAN L,HAN L,DU Y, et al. Discussion on the Application of Method Validation Data Set [J].Chin J Pharm Anal, 2022, 42(6):972
[10] 段丽,韩璐,杜颖,等. 方法满足预期用途的评估方式和标准探讨[J].药物分析杂志, 2022, 42(6):966
DUAN L,HAN L,DU Y, et al. Discussion about the evaluating indexes and criteria of assay for satisfying its intended use [J].Chin J Pharm Anal, 2022, 42(6):966
[11] ICH Q2(R2)Harmonised Guideline Validation of Analytical Procedure [S/OL]. (2022-03-24) [2022-03-25] 2022. https://www.ich.org/news/ich-revision-q2r2-draft-guideline-reaches-step-2-ich-process
