Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology

IF 4.8 2区 医学 Q1 TOXICOLOGY
Monica Piergiovanni, Milena Mennecozzi, Erio Barale-Thomas, Davide Danovi, Sebastian Dunst, David Egan, Aurora Fassi, Matthew Hartley, Philipp Kainz, Katharina Koch, Sylvia E. Le Dévédec, Iris Mangas, Elena Miranda, Jo Nyffeler, Enrico Pesenti, Fernanda Ricci, Christopher Schmied, Alexander Schreiner, Nadine Stokar-Regenscheit, Jason R. Swedlow, Virginie Uhlmann, Fredrik C. Wieland, Amy Wilson, Maurice Whelan
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引用次数: 0

Abstract

Imaging technologies are being increasingly used in biomedical research and experimental toxicology to gather morphological and functional information from cellular models. There is a concrete opportunity of incorporating imaging-based in vitro methods in international guidelines to respond to regulatory requirements with human relevant data. To translate these methods from R&D to international regulatory acceptance, the community needs to implement test methods under quality management systems, assess inter-laboratory transferability, and demonstrate data reliability and robustness. This article summarises current challenges associated with image acquisition, image analysis, including artificial intelligence, and data management of imaging-based methods, with examples from the developmental neurotoxicity in vitro battery and phenotypic profiling assays. The article includes considerations on specific needs and potential solutions to design and implement future validation and transferability studies.

从生物医学研究到调节毒理学的基于成像的体外方法的桥梁。
成像技术越来越多地用于生物医学研究和实验毒理学,从细胞模型中收集形态和功能信息。有一个具体的机会将基于成像的体外方法纳入国际准则,以响应与人类相关数据的监管要求。为了将这些方法从研发转化为国际监管认可,社区需要在质量管理体系下实施测试方法,评估实验室间的可转移性,并证明数据的可靠性和稳健性。本文总结了当前与图像采集、图像分析(包括人工智能)和基于图像方法的数据管理相关的挑战,并以体外发育神经毒性电池和表型分析分析为例。本文包括对设计和实施未来验证和可转移性研究的具体需求和潜在解决方案的考虑。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Archives of Toxicology
Archives of Toxicology 医学-毒理学
CiteScore
11.60
自引率
4.90%
发文量
218
审稿时长
1.5 months
期刊介绍: Archives of Toxicology provides up-to-date information on the latest advances in toxicology. The journal places particular emphasis on studies relating to defined effects of chemicals and mechanisms of toxicity, including toxic activities at the molecular level, in humans and experimental animals. Coverage includes new insights into analysis and toxicokinetics and into forensic toxicology. Review articles of general interest to toxicologists are an additional important feature of the journal.
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