Kluxen Felix M, Jensen Signe M
ADAMA Deutschland GmbH, Cologne, Germany.
Department of Plant and Environmental Sciences, University of Copenhagen, Copenhagen, Denmark.
EXCLI J. 2022 Aug 22;21:1130-1150. doi: 10.17179/excli2022-5097. eCollection 2022.
Statistical analyses are an essential part of regulatory toxicological evaluations. While projects would be ideally monitored by both toxicologists and statisticians, this is often not possible in practice. Hence, toxicologists should be trained in some common statistical approaches but also need a tool for statistical evaluations. Due to transparency needed in regulatory processes and standard tests that can be evaluated with template approaches, the freely available open-source statistical software may be suitable. is a well-established software in the statistical community. The principal input method is via software code, which is both benefit and weakness of the tool. It is increasingly used by regulating authorities globally and can be easily extended by software packages, e.g., for new statistical functions and features. This manuscript outlines how can be used in regulatory toxicology, allowing toxicologists to perform all regulatory required data evaluations in a single software solution. Practical applications are shown in case studies on simulated and experimental data. The examples cover a) Dunnett testing of treatment groups against a common control and in relation to a biological relevance threshold, assessing the test's assumptions and plotting the results; b) dose-response analysis and benchmark dose derivation for chronic kidney inflammation as a function of Pyridine; and c) graphical/exploratory data analysis of previously published developmental neurotoxicity data for Chlorpyrifos.
统计分析是监管毒理学评估的重要组成部分。虽然理想情况下项目应由毒理学家和统计学家共同监测，但在实际中这往往无法实现。因此，毒理学家应接受一些常见统计方法的培训，同时也需要一个用于统计评估的工具。由于监管过程需要透明度以及可以用模板方法评估的标准测试，免费的开源统计软件可能是合适的。 是统计界一款成熟的软件。主要输入方法是通过软件代码，这既是该工具的优点也是缺点。它在全球监管机构中越来越多地被使用，并且可以通过软件包轻松扩展，例如用于新的统计功能和特性。本手稿概述了 如何用于监管毒理学，使毒理学家能够在单一软件解决方案中执行所有监管要求的数据评估。在模拟和实验数据的案例研究中展示了实际应用。这些例子包括：a）将治疗组与共同对照组进行邓尼特检验，并与生物学相关性阈值相关联，评估检验假设并绘制结果；b）作为吡啶函数的慢性肾脏炎症的剂量反应分析和基准剂量推导；c）对先前发表的毒死蜱发育神经毒性数据进行图形/探索性数据分析。
