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试验样品再分析(ISR)如今已普遍用于法规依从的生物分析实验室,是评估生物分析方法的重现性、可靠性和准确度的基本措施之一。虽然统计数据显示,LC-MS/MS生物分析中95%以上的ISR符合接受标准,然而失败时依然值得进行充分的科学调查与评估,以发现其根本原因。本文从稳定性问题、人为因素、样品处理过程、方法固有缺陷等方面对小分子化学药物的ISR失败原因进行分类分析,并举例讨论ISR影响因素及改进措施,列出ISR失败后需查根溯源,重测ISR,撰写调查报告并分享讨论等调查流程,并就如何降低ISR失败率提出法规依从,充分了解化合物特性,使用真实样品考察稳定性的解决方案,最后对其前景进行展望。
Test sample reanalysis (ISR) is now commonly used in regulatory compliant bioanalysis laboratories and is one of the basic measures to assess the reproducibility, reliability and accuracy of bioanalysis methods. Although statistics show that more than 95% of ISRs in LC-MS / MS bioanalyses meet acceptance criteria, failure to do so still warrants adequate scientific investigation and assessment to identify the root cause. In this paper, the causes of ISR failure of small molecule chemical drugs are classified and analyzed from the aspects of stability, human factors, sample processing and inherent flaws of the method, and the influencing factors of ISR are discussed by examples. , Retesting the ISR, writing survey reports, and sharing the investigation flow. They also provided regulatory compliance on how to reduce the failure rate of ISRs, fully understood the characteristics of the compounds, used real samples to investigate the solutions to the stability problems, and finally looked into their prospects.