LTKB is a project at the FDA’s National Center for Toxicological Research to study drug-induced liver injury (DILI). Liver toxicity is the most common cause for the discontinuation of clinical trials on a drug, as well as the most common reason for an approved drug’s withdrawal from the marketplace. Because of this, DILI has been identified by the FDA’s Critical Path Initiatives as a key area of focus in a concerted effort to broaden the agency’s knowledge for better evaluation tools and safety biomarkers.
The objective of LTKB is to develop content-rich resources to improve our basic understanding of liver toxicity and to be used by scientific researchers, the pharmaceutical industry, and regulatory bodies. The project involves the collection of diverse data (e.g., DILI mechanisms, drug metabolism, histopathology, therapeutic use, targets, side effects, etc.) associated with individual drugs and the use of systems biology analysis to integrate these data for DILI assessment and prediction. Importantly, both conventional and high-throughput molecular biomarker assays will be conducted for the selected drugs. The goal is to develop novel biomarkers based on knowledge accumulated from the project.
FDA Users: The FDA version has additional features. It is available on the intranet under "Information Technology/NCTR Applications."
LTKB Contact Information
For questions or suggestions contact Weida Tong, Ph.D., NCTR at 870-543-7142 or firstname.lastname@example.org.
To report technical problems contact NCTRBioinformaticsSupport@fda.hhs.gov.
Chen, M.J., Vijay, V., Shi, Q., Liu, Z.C., Fang, H., and Tong, W.D. "FDA-Approved Drug Labeling for the Study of Drug-Induced Liver Injury," Drug Discovery Today, 16(15-16):697-703, 2011.