2013 Global Summit on Regulatory Science (GSRS13)
Dates: September 11-12, 2013
Location: Little Rock, Arkansas
Current Highlight from April 12, 2013
MicroRNAs as Translational Biomarkers for Drug-Induced Liver Injury
NCTR scientists published a review article in Biomarkers in Medicine (2013, 7: 307-315)3, which discusses the potential advantages and challenges of using microRNAs (miRNAs) as new translational biomarkers of drug-induced liver injury (DILI). miRNAs are small single-stranded RNA molecules that can alter the expression of various genes. Although miRNAs appear to be more sensitive and organ-specific than conventional DILI biomarkers, their true value remains to be fully assessed due to a lack of standard quantification methods and confirmatory studies.For additional information, please contact Qiang Shi, Ph.D., Innovative Safety and Technologies Branch, Division of Systems Biology, FDA/NCTR, or Donna Mendrick, Ph.D., Director, Division of Systems Biology, FDA/NCTR.
Preclinical Biomarkers of Idiosyncratic Drug-Induced Liver Injury
An NCTR scientist gave a presentation at the 2nd International Conference and Exhibition on Metabolomics and Systems Biology held in Northbrook, Illinois, on April 8-10, 2013. The talk focused on the use of metabolomics to evaluate preclinical biomarkers of hepatotoxicity; with special emphasis on common blood metabolite profiles between preclinical animals treated with drugs that cause observable liver injury and human patients with idiosyncratic drug-induced liver injury. The identification of common metabolite profiles could be useful in the development of improved clinical trial designs and improved detection of idiosyncratic DILI risk.
For additional information, please contact Richard Beger, Ph.D., Director, Biomarkers and Alternative Models Branch, Division of Systems Biology, FDA/NCTR.