Bioanalytical methods developed in accredited forensic toxicology laboratories need to be validated according to the ISO/IEC 17025 standards to demonstrate that a method is fit for the intended use. The evaluation of the validation data can be a time-consuming process without a streamlined procedure on a common platform or the aid of a specific software package. The objective of this work was to develop a Microsoft (MS) Excel (Redmond, WA, USA) template, which can rapidly generate all the required numerical and statistical validation results of a quantitative bioanalytical assay with minimal data entry and to provide documented traceability of the validation data directly to the instrument raw data. Evaluation of method validation data can be done easily by taking advantage of the power of statistical tools available within Excel. The three key features of the template were the development of six pertinent weighted linear calibration models, the variance in instrument response as a function of concentration and integrated one-way analysis-of-variance (ANOVA) tables. None of the ANOVA tables in this template need to be recreated whenever the source data changes, which is a major time savings when a method contains several dozen analytes. It takes ∼60 minutes per analyte to enter all the instrument raw data manually from the chromatograms. The final method validation results are summarized in a two-page validation summary report, whereas the associated data tables and graphs are presented in an additional 65 pages of digital information, which can be saved for electronic records using portable document format (PDF). This EZSTATSG1.xltm customized MS Excel method validation template and a completed PDF example are being provided as downloadable files in the Supplementary data link to offer an option to the scientific community for expediting the evaluation of validation data.

中文翻译：

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通过 EZSTATSG1 自定义 Microsoft Excel 模板利用异方差七点线性校准曲线评估生物分析方法验证数据

在经认可的法医毒理学实验室开发的生物分析方法需要根据 ISO/IEC 17025 标准进行验证，以证明该方法适合预期用途。验证数据的评估可能是一个耗时的过程，没有通用平台上的简化程序或特定软件包的帮助。这项工作的目的是开发一个 Microsoft (MS) Excel (Redmond, WA, USA) 模板，该模板可以以最少的数据输入快速生成定量生物分析分析所需的所有数值和统计验证结果，并提供记录的可追溯性验证数据直接转换为仪器原始数据。利用 Excel 中可用的统计工具的强大功能，可以轻松地评估方法验证数据。该模板的三个关键特征是开发了六个相关的加权线性校准模型、仪器响应随浓度变化的方差以及集成的单向方差分析 (ANOVA) 表。每当源数据发生变化时，都不需要重新创建此模板中的任何 ANOVA 表，这在方法包含几十种分析物时可以节省大量时间。从色谱图中手动输入所有仪器原始数据需要约 60 分钟。最终的方法验证结果汇总在一份两页的验证总结报告中，而相关的数据表格和图表显示在另外 65 页的数字信息中，这些信息可以使用便携式文档格式 (PDF) 保存为电子记录。这个 EZSTATSG1.