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

Imaging technologies are being increasingly used to gather morphological and functional information from cellular models in biomedical research and experimental toxicology. There is a concrete chance 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 summarizes current challenges associated with image acquisition, image analysis, and data management of imaging-based methods, with examples from the developmental neurotoxicity in vitro battery and phenotypic profiling assays. The article further includes considerations on the use of emerging technologies such as Artificial Intelligence, to provide an initial discussion around specific needs and potential solutions to design and implement future validation studies for the experts and regulatory community engaged in this activity.

PIERGIOVANNI Monica;  MENNECOZZI Milena;  BARALE-THOMAS Erio;  DANOVI Davide;  DUNST Sebastian;  EGAN David;  FASSI Aurora;  HARTLEY Matthew;  KAINZ Philipp;  KOCH Katharina;  LE DÉVÉDEC Sylvia;  MANGAS Iris;  MIRANDA Elena;  NYFFELER Johanna;  PESENTI Enrico;  FERNANDA Ricci;  SCHMIED Christopher;  SCHREINER Alexander;  STOKAR Nadine;  SWEDLOW Jason;  UHLMANN Virginie;  WIELAND Fredrik;  WILSON Amy;  WHELAN Maurice; 

2025-04-04

SPRINGER HEIDELBERG

JRC139411

1432-0738 (online),   

https://link.springer.com/article/10.1007/s00204-024-03922-z#citeas,    https://doi.org/10.1007/s00204-024-03922-z,    https://publications.jrc.ec.europa.eu/repository/handle/JRC139411,   

10.1007/s00204-024-03922-z (online),