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Model‐based prediction of the acute and long‐term safety profile of naproxen in rats

Despite the increasing importance of biomarkers as predictors of drug effects, toxicology protocols continue to rely on the experimental evidence of adverse events (AEs) as a basis for establishing the link between indicators of safety and drug exposure. Furthermore, biomarkers may facilitate the translation of findings from animals to humans. Combined with a model‐based approach, biomarker data have the potential to predict long‐term effects arising from prolonged drug exposure. Here, we used naproxen as a paradigm to explore the feasibility of a biomarker‐guided approach for the prediction of long‐term AEs in humans.