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PhUSE Nonclinical Subteam Update

PhUSE Nonclinical Subteam Update. Endpoint Predictivity. Endpoint Predictivity. Goal Use actual nonclinical and clinical electronic data to increase our understanding of the ability to use nonclinical toxicity data to predict clinical effects or adverse events Accomplishments

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PhUSE Nonclinical Subteam Update

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  1. PhUSE Nonclinical Subteam Update Endpoint Predictivity

  2. Endpoint Predictivity • Goal • Use actual nonclinical and clinical electronic data to increase our understanding of the ability to use nonclinical toxicity data to predict clinical effects or adverse events • Accomplishments • Created a rudimentary database of present and historical efforts related to Endpoint Predicitivity • Delivered two simple use cases for interrogating available nonclinical and clinical databases • Challenges • Access to FDA data and tools did not become available in a timely fashion • Recommendations • In light of progress to-date, how shall the group continue?

  3. Topics for future work • Please provide additional topics for Working Group 6. • Topics may have evolved from your team’s work or may be entirely new topics which are unrelated to your current efforts.

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