The overall objective of Risk-IT is to accelerate the transition of chemical safety testing from animal-based approaches with limited predictivity for human risk to more predictive, animal-sparing solutions by developing new mechanism-based in vitro methods and providing a proof-of-concept for the successful integration of mechanistic endpoints and QIVIVE modelling for regulatory purposes.
The main scientific aims of Risk-IT are:
- to integrate expert knowledge and existing and newly developed ‘omics data to develop a systems-toxicology-based mechanistic framework for drug/chemical-induced nephrotoxicity in line with the AOP concept
- to use the developed mechanistic framework to establish a fit-for-purpose, battery of mechanism-based in vitro assays for prediction of human drug/chemical safety for nephrotoxicity
- to provide a proof-of-concept for the successful integration of new mechanism-based in vitro methods and QIVIVE into a tiered testing strategy that is fit-for-purposes of regulatory decision making
- to assess the confidence of risk assessment based on in vitro data