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Metabolomics in Preclinical Drug Safety Assessment: Current Status and Future Trends
Fenna Sillé1, Thomas Hartung1,2
1Center for Alternatives to Animal Testing (CAAT), Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health and Whiting School of Engineering, Johns Hopkins University, Baltimore, MD 21205, USA.
Metabolomics, a systems biology tool, enhances preclinical drug safety by revealing toxicity mechanisms and biomarkers. Further validation is needed for regulatory use, but it promises better risk assessment and predictive toxicology.
Area of Science:
- Systems biology
- Toxicology
- Drug development
Background:
- Metabolomics is a powerful approach for preclinical drug safety assessment.
- It aids in understanding toxicity mechanisms and disease pathogenesis.
Purpose of the Study:
- To review current applications and future trends of metabolomics in toxicology and drug development.
- To highlight metabolomics' role in elucidating adverse outcome pathways and identifying toxicity biomarkers.
Main Methods:
- Review of existing literature on metabolomics applications in toxicology and drug safety.
- Discussion of integration with other 'omics' technologies and computational approaches.
Main Results:
- Metabolomics elucidates biochemical alterations underlying toxicity.
- It improves characterization of environmental exposures and their health impacts.
- Metabolomics is increasingly used in safety evaluations for mechanistic insights.
Conclusions:
- Metabolomics offers significant promise for understanding toxicity, enhancing safety screening, and improving risk assessment.
- Reliability through quality assurance and interlaboratory studies is crucial for regulatory acceptance.
- Future applications will integrate metabolomics with computational, in vitro, and personalized medicine.
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