Sensitivity Analysis of the Inputs for Bioactivity-Exposure Ratio Calculations in a NAM-Based Systemic Safety Toolbox.

ABSTRACT: To support regulatory decision-making without animal testing, Next-Generation Risk Assessment (NGRA) frameworks leverage New Approach Methodologies (NAM). A widely used strategy in such frameworks is to calculate Bioactivity-Exposure Ratios (BERs), which compare NAM assay-derived points of departure (PODs) and estimated human internal exposures. However, key methodological choices in NGRA, such as toxicokinetic modeling software, POD sources, and adjustments for in vivo and in vitro free concentrations, may introduce uncertainty. To determine the robustness of our previously reported NGRA workflow, we conducted a comprehensive sensitivity analysis of these variables as applied to 35 chemicals covering a range of end uses including consumer, pesticide and pharmaceutical. Physi

SUBMITTER: Lin HC 

PROVIDER: S-EPMC12721856 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature