to better markers for toxicity, but accomplishing this will require a true interdisciplinary approach involving experts in all relevant fields.

  • Emerging safety science has already made it possible to better classify compounds through new genomic and other technologies.

  • Researchers need to qualify markers for bridging studies, as well as those for addressing idiosyncratic events.

  • Nephrotoxicty biomarkers will be submitted to the FDA for review this year, and a process for reviewing these markers is being established.4

  • Genomic association studies (including, for example, whole-genome SNP scanning) have the potential to identify markers for rare adverse events, but access to well-characterized samples remains a problem.

  • New mechanisms and processes for studying clinical and postmarket safety need to be explored.

4

Following the workshop, the Predictive Safety Testing Consortium’s nephrotoxicity biomarker package was submitted to the FDA for review.



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