Thomas More University of Applied Sciences, Geel, Belgium; Data Science Institute, CenStat, I-BioStat, Hasselt University, Diepenbeek, Belgium.
Thomas More University of Applied Sciences, Geel, Belgium.
NanoImpact. 2024 Jul;35:100524. doi: 10.1016/j.impact.2024.100524. Epub 2024 Jul 24.
Nanomaterials are increasingly used in many applications due to their enhanced properties. To ensure their safety for humans and the environment, nanomaterials need to be evaluated for their potential risk. The risk assessment analysis on the nanomaterials based on animal or in vivo studies is accompanied by several concerns, including animal welfare, time and cost needed for the studies. Therefore, incorporating in vitro studies in the risk assessment process is increasingly considered. To be able to analyze the potential risk of nanomaterial to human health, there are factors to take into account. Utilizing in vitro data in the risk assessment analysis requires methods that can be used to translate in vitro data to predict in vivo phenomena (in vitro-in vivo extrapolation (IVIVE) methods) to be incorporated, to obtain a more accurate result. Apart from the experiments and species conversion (for example, translation between the cell culture, animal and human), the challenge also includes the unique properties of nanomaterials that might cause them to behave differently compared to the same materials in a bulk form. This overview presents the IVIVE techniques that are developed to extrapolate pharmacokinetics data or doses. A brief example of the IVIVE methods for chemicals is provided, followed by a more detailed summary of available IVIVE methods applied to nanomaterials. The IVIVE techniques discussed include the comparison between in vitro and in vivo studies, methods to rene the dose metric or the in vitro models, allometric approach, mechanistic modeling, Multiple-Path Particle Dosimetry (MPPD), methods using organ burden data and also approaches that are currently being developed.
由于具有增强的特性，纳米材料在许多应用中越来越多地被使用。为确保其对人类和环境的安全性，需要对纳米材料的潜在风险进行评估。基于动物或体内研究的纳米材料风险评估分析伴随着一些关注，包括动物福利、研究所需的时间和成本。因此，越来越多地考虑将体外研究纳入风险评估过程。为了能够分析纳米材料对人类健康的潜在风险，有一些因素需要考虑。在风险评估分析中利用体外数据需要采用能够将体外数据转化为预测体内现象的方法（体外-体内外推（IVIVE）方法），以获得更准确的结果。除了实验和物种转化（例如，细胞培养、动物和人类之间的翻译）之外，挑战还包括纳米材料的独特性质，这些性质可能导致它们与相同材料的块状形式表现不同。本文概述了用于外推药代动力学数据或剂量的 IVIVE 技术。提供了化学物质 IVIVE 方法的简要示例，然后更详细地总结了适用于纳米材料的可用 IVIVE 方法。讨论的 IVIVE 技术包括体外和体内研究之间的比较、改变剂量度量或体外模型的方法、比例方法、机制建模、多路径粒子剂量测定（MPPD）、使用器官负荷数据的方法以及目前正在开发的方法。
