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

ABSTRACT:

Background and purpose

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.

Experimental approach

An experimental toxicology protocol was set up for evaluating the effects of naproxen in rats, in which four acti

SUBMITTER: Sahota T 

PROVIDER: S-EPMC4523341 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature