The detection and assessment of drug induced liver disease has emerged as a challenging task due to the low incidence of findings and the burdensome work of searching through massive quantities of data sets. A method to assist medical diagnosis to identify sometimes rare but serious cases of drug induced liver disease is of interest.
To address this issue, FDA researchers have created a software tool for assisting differential medical diagnosis of drug-induced liver injury (hepatotoxicity) using clinical trial data. The software can identify a small subset of patients at risk for hepatotoxicity out of a pool of thousands of clinical trial participants. This software tool is the only one of its kind developed using SAS/IntrNet®.
Potential Commercial Applications
- Hepatotoxicity detection
- Drug interactions
- Personalized predictions
- SAS/IntrNet® compatible
Development Stage: Software Tool - Patent protection is not being pursued for this technology.
Guo T, et al. A Tool to Help You Decide [detect potentially serious liver injury]. Silver Spring, Maryland: Presentation at the Annual Conference of the American Association for the Study of Liver Diseases, 2008. PMID 21332248
Guo T, et al. How a SAS/IntrNet tool was created at the FDA for the detection of potential drug-induced liver injury using data with CDISC standard. San Diego, California: Proceedings of the Western Users of SAS Software Annual Conference, 2009.
Product Area: Software
FDA Reference No: E-2012-008
Ken Millburne, J.D.
FDA Technology Transfer Program