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Increasing the utility of epidemiologic studies as key evidence in chemical risk assessment
Heather R Schaefer1, Melissa J Vincent2, Carol J Burns3
1US Food and Drug Administration (FDA), College Park, MD 20740, United States.
Abstract:
The Society of Toxicology 2024 meeting assembled risk assessors, epidemiologists, and toxicologists to discuss the utility of integrating epidemiologic data into the derivation of reference values. Advantages of the use of epidemiologic evidence include (i) human relevance; (ii) increased likelihood that exposure levels are relevant to risk assessment; and (iii) incorporation of uncertainties attributed to co-exposures or other population-based considerations. The workshop panelists discussed the challenges of incorporating epidemiologic evidence due to uncertain exposure measurements, confounding, heterogeneity, and inherent study design limitations. Capturing uncertainty is a critical step. In summary, epidemiologic evidence can be a valuable tool for risk analysis. This workshop brief captures constructive considerations from practitioners in the field that can increase the utility of epidemiologic studies in chemical risk assessment and harmonize the approach for use in dose-response assessment that will ultimately reduce uncertainty related to chemical exposures.
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