NCTR Publications > NCTR Research Highlights

Toxicogenomic Models in Predictive Toxicology

NCTR studies showed that a short-term toxicogenomic (TGx) study outperformed Quantitative Structure-Activity Relationships (QSAR), an in silico approach, in predicting the power or tendency of 62 chemicals to produce cancer of the liver without causing genetic mutations. These chemicals were selected from the NCTR Liver Cancer Database2. In an independent validation set, 1-, 3-, and 5-day TGx models had predictive accuracies of 0.77, 0.77, and 0.82, respectively, whereas the QSAR model had an accuracy of 0.55. Thus, TGx modeling may provide a more accurate method to prioritize chemicals for the more time-consuming and labor-intensive 2-year rodent bioassay. A manuscript describing this study has recently been accepted for publication in the journal, Chemical Research in Toxicology.

For additional information, please contact Weida Tong, Ph.D., Division of Systems Biology, FDA/NCTR.


Drug-Induced Hepatotoxicity in Pediatric Patients—June 8

William Salminen, Ph.D., presented an invited talk at the 10th Annual World Pharma Congress, Drug Safety Summit: New Assays and Tools for Predicting Hepatotoxicity in Philadelphia, Pennsylvania. The presentation reviewed the major developmental phases of the maturing liver with an emphasis on phases that may pose unique sensitivities to drug-induced liver injury in children, which is an underserved area of research.

For additional information or a copy of the PowerPoint presentation, “Pediatric Drug-Induced Liver Injury – Children Are Not Just Small Adults,” please contact Dr. William Salminen, Division of Systems Biology, FDA/NCTR.


Identification of Nephrotoxicity Biomarkers Using Toxicoproteomics—June 9

An NCTR scientist presented work at a symposium, “Biomarkers of Drug/Metabolite Toxicity: LC-MS Methods” in Denver, Colorado. The presentation focused on the utilization of toxicoproteomics to identify potential pathways and networks associated with nephrotoxicity and the identification of potential biomarkers of drug-induced nephrotoxicity that have been qualified by FDA for nonclinical use.

For additional information or a copy of the PowerPoint presentation, “Toxicoproteomics for the Identification of Nephrotoxicity Biomarkers and Pathways,” please contact LiRong Yu, Ph.D., Division of Systems Biology, FDA/NCTR.

NCTR Publications > NCTR Research Highlights