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  1. Liver Toxicity Knowledge Base (LTKB)

LTKB Benchmark Dataset

Benchmark Dataset for the Liver Toxicity Knowledge Base

About LTKB Benchmark Dataset

NCTR scientists have developed a benchmark dataset (LTKB-BD) containing drugs whose potential to cause DILI (Drug-Induced Liver Injury) in humans has been established using the FDA-approved prescription drug labels. The first set of drugs examined are these that have been available for ten or more years and are available commercially from one of three large chemical supply companies.

After reviewing the labels of 287 prescription drugs the following was found:

  • 137 most-DILI-concern drugs which are either withdrawn/discontinued from the markets or have a "Boxed Warning" label due to hepatotoxicity, or come from the "Warnings and Precautions" section with severe DILI content
  • 85 less-DILI-concern drugs whose DILI events are highlighted in the "Adverse Reactions" section or "Warnings and Precautions" section with mild DILI content
  • 65 no-DILI-concern drugs whose labels did not contain any DILI indication


FDA-Approved Drug Labeling for the Study of Drug-Induced Liver Injury.
Chen M., Vijay V., Shi Q., Liu Z., Fang H., and Tong W.
Drug Discovery Today. 2011, 16(15-16):697-703.

LTKB Contact Information

Questions or Suggestions
Weida Tong, Ph.D., NCTR at 870-543-7142 or weida.tong@fda.hhs.gov.

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