Citation:

Slikker, W., L. Wu, J. Xu, AND T. Shafer. 7.11 - In pursuit of precision medicine for brain injury and neurotoxicity and improved protection of human health. Edition First, Kenneth S. Ramos (ed.), Comprehensive Precision Medicine. ELSEVIER, AMSTERDAM, Holland, 2:495-510, (2024). https://doi.org/10.1016/B978-0-12-824010-6.00048-4

Impact/Purpose:

Assessment of Developmental Neurotoxicity (DNT) using animal-based Guideline studies is expensive, time consuming, and does not always yield actionable data. Further, DNT assessment is not required under TSCA and the Guideline DNT study is a triggered study under FIFRA. Consequently, few of the tens of thousands of chemicals to which humans may be exposed have been evaluated for DNT hazard. To address this issue, New Approach Methodologies (NAMs) are being developed that can help provide data for risk decisions under FIFRA and TSCA. As these methods become more widely utilized, they can also provide information for other types of environmental decision-making as well.

Description:

Brain health is a major individual and community issue with impacts on quality of life for the individual and economic wellbeing of the nation. The need to assess and protect the nervous system demands enhancement of biomarker development and the application of precision medicine approaches. Although strategies for safety assessment and precision medicine to protect the nervous system have been evolving over many years, each new approach needs to be rigorously evaluated to determine its readiness for incorporation into the assessment process. Although some of the experimental approaches reviewed here including imaging, omics, behavioral assessment, and artificial intelligence/machine learning (AI/ML) have been proposed and/or incorporated into routine nervous system assessment, many of them will require more evaluation before regulatory acceptance. Critical features of these new approaches including reproducibility, reliability and robustness will need to be validated. To expedite this validation process, it is recommended that a teamwork approach including product developers, academic researchers, and regulators provide biomarker and precision medicine strategies to protect the nervous system.

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