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.


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

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