Are Non-animal Systemic Safety Assessments Protective? A Toolbox and Workflow.

ABSTRACT: An important question in toxicological risk assessment is whether non-animal new approach methodologies (NAMs) can be used to make safety decisions that are protective of human health, without being overly conservative. In this work, we propose a core NAM toolbox and workflow for conducting systemic safety assessments for adult consumers. We also present an approach for evaluating how protective and useful the toolbox and workflow are by benchmarking against historical safety decisions. The toolbox includes physiologically based kinetic (PBK) models to estimate systemic Cmax levels in humans, and 3 bioactivity platforms, comprising high-throughput transcriptomics, a cell stress panel, and in vitro pharmacological profiling, from which points of departure are estimated. A Bayesian model was

SUBMITTER: Middleton AM 

PROVIDER: S-EPMC9412174 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature