With the FDA announcement that it is no longer a requirement to test on animals prior to human trials; there is potential for a paradigm shift in the conduct of regulatory investigations. This white paper will look at examples on how a simple search in the integrated database can pull results from multiple preclinical and clinical studies from several disparate databases. We will show how event counts within the MedDRA system organ class (SOC) terms can overlap with pre-clinical SOC results across the databases and how the nature of these potentially translationally relevant findings was investigated by reviewing the results.
You can expect to learn how findings can be seen across humans, monkeys, rats and dogs and how this could impact earlier decision making, and reduce the need for as much animal testing.
Finally, we will learn about how to integrate such data with a unifying ontology for terminology to enable an optimized review of the data.
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