生物样品定量分析方法验证中试验样品再分析的意义和对策

Significance and Implementation Strategy of Incurred Sample Reanalysis in Bioanalytical Method Validation

目的介绍试验样品再分析(incurred sample reanalysis,ISR)的法规要求、意义和对策。方法综述国际上关于试验样品再分析的指导原则、研究论文和统计数据,通过实例来总结试验样品再分析失败的原因及预防措施。结果与结论试验样品再分析有助于改善生物分析方法的重现性,已经成为法规生物样品分析的一项重要内容。采取适当的对策,可以防止试验样品再分析失败造成的损失。

OBJECITVE To we summarize the background, evolution and implementation of incurred sample reanalysis （[SR） for bioanalysis. METHODS Based on the available guidance documents, research papers and statistical data, some selected case studies are outlined to help understand the root causes of ISR failures and how to prevent and correct the errors. RESULTS AND CONCLUSION ISR program may improve the reproducibility of bioanalytical assays, and has become an integral part of regulatory guidance. To avoid ISR failure, precautions must be taken in the early stage of method development.