摘要
目的:明确交叉验证在生物样品分析测试中的必要性,建立生物样品分析中两台分析测试仪器之间交叉验证的操作规程。方法:参阅国际上有关方法学确证的指导原则及文献,通过一定数量的外标样品和给药后样品在两台分析测试仪器上的分析结果,经过统计,判定是否符合交叉验证的可接受标准。结果:本实验中通过对28个样本量的样品分析,双机测试的结果符合标准,双机测试的数据可以合并使用。结论:生物样品分析中,需要双机测试结果数据合并的时候,需要进行交叉确证。
Objective： To define the need for cross-validating bioanalytical methods between different analifical equipments to al- low comparison of data and built a scheme for use in cross-validation. Method ： The bioanalytieal validation reflected in FDA guidelines and other publications were referenced, the procedure of bioanalytical method cross-validation with QC samples and incurred samples was developed. The statistical techniques was used to compare data sets and establish acceptability of the assays. Result： The data of 28 samples met the criteria and demonstrated that two different analytical equipments generate comparable data. Conclusion： The procedure uses estimations of variability of two different analvltical equipments is essential in generating comnarable data.
出处
《中国药师》
CAS
2010年第6期842-843,共2页
China Pharmacist
