[关键词]
[摘要]
在生物标志物分析方法学验证项中,稳定性验证是难点。与药动学分析不同的是,生物标志物分析待测物为内源性物质,其稳定性与标准品(一般为重组蛋白)有很大不同。所以,生物标志物稳定性验证样品应采用内源性真实样本。但是受分析方法变异影响,内源性真实样本的准确浓度无法得知,而且难以获取新鲜的未冻存过的样本,最终导致稳定性的接受标准难以界定。运用趋势控制图和计算机分析等手段可以更准确地判断生物标志物的稳定性。
[Key word]
[Abstract]
In biomarker bioanalytical method validation, one of the most challenges is stability. Compared with pharmacokinetic (PK) assays, the analytes of biomarker assay is endogenous. The stability of endogenous analytes is differed with its corresponding recombinant reference standard. To that end, biomarker stability evaluation should be performed using endogenous incurred sample. However, the accurate concentration of endogenous sample is difficult to assess due to the assay variation. In addition, it is hard to acquire fresh unfrozen sample. All above factors lead to the difficulty of defining acceptance criteria for stability evaluation. Trending chart and computational analysis could be used to determine biomarker stability more accurately.
[中图分类号]
R967
[基金项目]
“十三五”重大专项(2018ZX09201017-008)