理化方法验证统计分析软件的设计与功能
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摘要
理化方法验证统计分析软件"是一款专用于理化分析方法验证数据统计分析的软件,不仅可提供通用的准确度、精密度、线性、范围、检测下限和定量下限等常见方法验证性能参数,还提供包括准确度的置信区间,精密度的置信上限,方法变异的容忍区间、预测区间、方法能力指数(MCI)等评价方法是否满足需求的指标。该软件简便易用,结果输出经验证科学可靠,可以满足各国现行药典或指南对方法验证的要求。
Statistical software for validation of analytical procedures is a software dedicated to the statistical analysis of the validation data of physical and chemical procedures. It could provide not only the common performance parameters for procedure validation,such as accuracy,precisions,linearity,range,limit of detection,and limit of quantitation,but also new parameters to evaluate whether the procedures meet their requirements,such as the confidence interval of accuracy,the upper confidence limit of precision,the tolerance interval of method variability,the predictive interval as well as method capacity index(MCI)of the procedures. The software is simple and easy to use. The output results are verified to be scientific and reliable. The software can meet all the requirements for validation of analytical procedures of current pharmacopoeia or guidelines of different countries.
Statistical software for validation of analytical procedures is a software dedicated to the statistical analysis of the validation data of physical and chemical procedures. It could provide not only the common performance parameters for procedure validation,such as accuracy,precisions,linearity,range,limit of detection,and limit of quantitation,but also new parameters to evaluate whether the procedures meet their requirements,such as the confidence interval of accuracy,the upper confidence limit of precision,the tolerance interval of method variability,the predictive interval as well as method capacity index(MCI)of the procedures. The software is simple and easy to use. The output results are verified to be scientific and reliable. The software can meet all the requirements for validation of analytical procedures of current pharmacopoeia or guidelines of different countries.
引文
[1]USP 41-NF 36[S].2018:7622(<1210> Statistical Tools for Procedure Validation)
[2]中华人民共和国药典2015年版.四部[S].2015:374(9101)ChP 2015.VolⅣ[S].2015:374(9101)
[3]USP 41-NF 36[S].2018:7665(<1225> Validation of compendial Procedures)
[4]ICH Q2(R1).Validation of Analytical Procedures Text and Methodology[S].2005
[5]OMCL Network of the Council of Europe.PA/PH/OMCL(13)822R,Validation_of_analytical_procedures[S].(2015)[2018-12-9].https://www.edqm.eu/en/quality-management-guidelines-86.html
[2]中华人民共和国药典2015年版.四部[S].2015:374(9101)ChP 2015.VolⅣ[S].2015:374(9101)
[3]USP 41-NF 36[S].2018:7665(<1225> Validation of compendial Procedures)
[4]ICH Q2(R1).Validation of Analytical Procedures Text and Methodology[S].2005
[5]OMCL Network of the Council of Europe.PA/PH/OMCL(13)822R,Validation_of_analytical_procedures[S].(2015)[2018-12-9].https://www.edqm.eu/en/quality-management-guidelines-86.html