The overall aim of Predict-IV is to develop strategies to improve the assessment of drug safety in the early stage of development and late discovery phase, by an intelligent combination of non animal-based test systems, cell biology, mechanistic toxicology and in-silico modelling, in a rapid and cost effective manner. A better prediction of the safety of an investigational compound in early development will be delivered, by applying advances in predictive toxicology (toxicogenomics and metabolomics, prediction of pharmacokinetics and high content imaging) and modelling. Margins-of-safety will be deduced and the data generated by the proposed approach may also identify early biomarkers of human toxicity for pharmaceuticals. The results obtained in Predict-IV will enable pharmaceutical companies to create a tailored testing strategy for early drug safety.
Predict-IV aims to derive a decision scheme mainly focusing on non-animal test systems. Furthermore, because it will apply advanced scientific tools, such as “omics” technologies and high-content imaging, this project will help to improve the early identification of toxic effects and inappropriate pharmacokinetics of drugs and contribute to the elucidation of mode-of-action for new compounds. The resulting reduction of animal experimentation by using an in vitro approach will bring a substantial improvement towards the 3Rs principles.