FDA-approved drug labeling for the study of drug-induced liver injury
Abstract
Drug-induced liver injury (DILI) is a leading cause of drugs failing during clinical trials and being withdrawn from the market. Comparative analysis of drugs based on their DILI potential is an effective approach to discover key DILI mechanisms and risk factors. However, assessing the DILI potential of a drug is a challenge with no existing consensus methods. We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts. The method is transparent and reproducible with a potential to serve as a common practice to study the DILI of marketed drugs for supporting drug discovery and biomarker development.
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The NCTR has produced drug-induced toxicity benchmark datasets by manually reading and analyzing drug labeling documents, such as DILI, DICT, and DIRIL.
“during the past two decades, the research team at the NCTR has produced several drug-induced toxicity benchmark datasets by manually reading and analyzing drug labeling documents, such as those for drug-induced liver injury (DILI) [9–11], drug-induced cardiotoxicity (DICT) [12], drug-induced renal injury list (DIRIL) [13], and others”
From Leveraging FDA Labeling Documents and Large Language Model to Enhance Annotation, Profiling, and Classification of Drug Adverse Events with AskFDALabel (2025) · cites this paper as [9]
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References 41 · Cited by 406
- Authors
- Chen, M., Vijay, V., Shi, Q., Liu, Z., Fang, H., & Tong, W.
- Affiliations
- National Center for Toxicological Research (US)
- Corresponding author
- Tong, Weida
- Venue
- Drug Discovery Today
- Publisher
- Elsevier BV
- Published
- 2011-08
- Volume
- 16
- Issue
- 15-16
- Pages
- 697-703
- ISSN
- 1359-6446 (ISSN-L)
- OpenAlex
- W2087561463
- Cited by
- 406
- References
- 41
- Citations by year
- 2026: 18 · 2025: 25 · 2024: 20 · 2023: 25 · 2022: 29 · 2021: 39 · 2020: 34 · 2019: 21 · 2018: 35 · 2017: 35 · 2016: 31 · 2015: 23 · 2014: 28 · 2013: 28 · 2012: 11
- FWCI
- 23.71
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Drug Discovery Today (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Physical Sciences › Computer Science › Computational Theory and Mathematics › Computational Drug Discovery Methods
- Keywords
- drug-induced liver injury, benchmark dataset, marketed drugs, drug safety, drug discovery
- MeSH terms
- Animals, Drug Labeling, Pharmaceutical Preparations, Humans, United States, United States Food and Drug Administration, Drug Design, Reproducibility of Results, Benchmarking, Biomarkers, Pharmacological, Chemical and Drug Induced Liver Injury, Drug-Related Side Effects and Adverse Reactions
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