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Activity Number:
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299
- Risk Analysis: New Data, New Approaches, and New Interfaces
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Type:
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Invited
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Date/Time:
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Wednesday, August 11, 2021 : 3:30 PM to 5:20 PM
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Sponsor:
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Section on Risk Analysis
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Abstract #316589
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Title:
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Statistical Methods for Bridging the Gap Between in Vitro Assays and Postmarket Surveillance Data
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Author(s):
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Dong Wang*
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Companies:
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National Center for Toxicological Research/FDA
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Keywords:
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postmarket suveillance;
in vitro assays;
toxicity;
DILI
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Abstract:
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Though animal-based testing regime has been the mainstay of drug toxicity assessment, it often fails to illuminate the biological mechanisms of toxicity. In vitro assays have the advantage of being high throughput and able to pinpoint specific biological processes, but are often criticized for the lack of validation with direct human evidence. Current development in collecting and utilizing real-world patient data has provided unique opportunities to corroborate results from in vitro assays using human evidence of drug toxicity. However, bridging the gap between in vitro assays and real-world human data requires novel statistical approaches. In this paper, we provide examples on progresses in this area, focusing on drug induced liver injury (DILI) using a wide range of in vitro assays and real-world evidence from FDA Adverse Event Reporting System (FAERS) database and National Center for Health Statistics (NHANES) surveys. We demonstrate that predictions of toxicity using in vitro assays can be validated with data from FAERS. We adapted models in safety signal detection to accommodate covariates thus extend the scope of utilizing postmarket surveillance databases.
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Authors who are presenting talks have a * after their name.
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