The 2016 Global Summit on Regulatory Science (GSRS16) with the theme of “Nanotechnology Standards and Applications” was hosted by FDA, the Global Coalition for Regulatory Science Research (GCRSR), and the Arkansas Research Alliance at the National Institutes of Health (NIH) Campus in Bethesda, MD on September 7-9. Panel discussions and speaker presentations, including FDA Commissioner Dr. Robert M. Califf, explored the most immediate research needs in nanotechnology science, measurement methods, and standards relevant to regulatory applications. The international conference provided a forum for scientists from government, industry, and academia from 19 countries to facilitate coordination of the development of these emerging technologies and standards to improve regulatory processes.
For more information, please contact William Slikker, Jr., Ph.D., Director, FDA/NCTR.
Model to Predict Severity of Drug-Induced Liver Injury (DILI) in Humans
Scientists from NCTR and Hannover Medical School (Germany) have developed an algorithm to quantitatively estimate the severity of a liver-related adverse event associated with an oral medication. This predictive model - DILIScore - improves upon a previous model, the Rule-of-Two (RO2) that assesses DILI in a binary fashion (yes/no). DILIScore includes reactive metabolite formation in addition to the daily dose and logP originally considered by the RO2 model. DILIScore has the ability to distinguish between different DILI severity within drug pairs that are defined as structurally similar and that have a similar mode-of-action. A manuscript describing the study is available online at Hepatology and the DILI Score calculator is available through the Liver Toxicity Knowledge Base (LTKB).
For additional information, please contact Weida Tong, Ph.D., Division of Bioinformatics and Biostatistics, FDA/NCTR.
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