摘要
目的探讨可用于药品检验系统开展能力验证的数据统计方法。方法结合国内外各行业开展实验室比对或能力验证活动时数据的处理情况,对统计方法进行梳理。讨论了经典统计方法中的Grubbs检验法和Dixon检验法,稳健统计方法中的四分位法和迭代法,总结了各统计方法的使用特点。结果每一种统计方法均有其优点和适用条件。结论建议根据检测结果的数据特征选择合适的统计方法。
OBJECTIVE To explore the statistical methods for proficiency testing in the drug control field. METHODS The statistical methods were sorted out with data processing used in inter-laboratory and proficiency testing by various industries both at home and abroad. The Grubbs test and Dixon test in classical statistical method were focused on as well as quartile method and iterative method in the robust statistical method, and the characteristics of the different statistic methods was summarized respectively. RESULTS Every method has its advantages and application conditions. CONCLUSION It is suggested that proper statistical method be chosen according to the data characteristics of the test results.
作者
赵新玥
陈华
ZHAO Xin-yue CHEN Hua(China Pharmaceutical University,Nanjing 211100, China National Institutes for Food and Drug Control,Beijing 100050, China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2017年第4期319-322,共4页
Chinese Pharmaceutical Journal
关键词
能力验证
统计方法
经典统计法
稳健统计法
药品检验
proficiency testing
statistical method
classical method
robust statistical method
drug test
