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Serum biomarkers of drug‐induced liver injury: Current status and future directions
Abstract
Drug‐induced liver injury (DILI), which is caused by drugs and herbal or dietary supplements, remains a serious concern for drug developers, regulators, and clinicians; however, serum biomarkers utilized to detect and monitor DILI have not changed in decades and have limitations. Data‐driven mathematical modeling that incorporates the release and clearance kinetics of traditional biomarkers has improved their use in the prediction of liver safety liabilities for new drug candidates. Several newer biomarkers have shown promise in terms of liver specificity, predicting the outcome of DILI events, and providing insight into its underlying mechanisms. For these new biomarkers to be qualified for regulatory acceptance, it will require their assessment in large numbers of patients who are receiving a wide range of compounds and who develop a broad spectrum of liver injuries. The ongoing and evolving international biomarker consortia should play a major role in this effort, which is likely to transform the assessment of liver safety in clinical trials and in the clinic.
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DILI-specific biomarkers have not yet been fully translated into the clinic.
“Although research into the discovery and qualification of DILI‐specific biomarkers has yielded interesting results, these have not yet been fully translated into the clinic”
From Methods for causality assessment of idiosyncratic drug‐induced liver injury (2025) · cites this paper as [12]
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Methods for causality assessment of idiosyncratic drug‐induced liver injury
García‐Cortés, M., Matilla‐Cabello, G., & Lucena, M. I. (2025) · Liver International · doi:10.1111/liv.16083 · Cited by 15
Metadata
- Authors
- Church, R. J., & Watkins, P. B.
- Affiliations
- Institute for Drug Safety Sciences University of North Carolina at Chapel Hill Research Triangle Park North Carolina USA
- Venue
- Journal of Digestive Diseases
- Publisher
- Wiley
- Published
- 2018-12-05
- Volume
- 20
- Issue
- 1
- Pages
- 2-10
- ISSN
- 1751-2972
- 1751-2980
- Cited by
- 27
- References
- 6
- Language
- en
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