The EU White Paper 'Strategy for a future chemical policy¿ proposes to harmonise the testing requirement for existing chemicals, by developing a new system for the "Registration, Evaluation and Authorisation of Chemicals" (REACH). Given the existing regulation, this could result in a large increase in animal use. Thus, the need of reliable alternative in vitro models becomes urgent. Although several in vitro models are available, they are not yet accepted into regulations, as they still require better characterisation and optimisation to reach the validation stage.
The main aim of this project is to provide optimised established protocols and experimental in vitro models for testing intestinal and liver absorption, metabolism and toxicity of molecules of pharmacological interest. The added value of the project is to provide optimised sequential procedures, easily amenable to validation studies for screening and testing of new drugs, possibly by miniaturized and automated technology. The direct participation of SMEs in the research activities will assure that those procedures will also fit with the requirements of industrial application. The project is articulated in integrated work packages and research objectives, interacting at various levels. Different liver and intestinal cellular models will be optimised for applications that are relevant to the drug development process.
The optimised models will be challenged with structurally diverse reference drugs, chosen with the help of a steering committee of relevant stakeholders, to develop innovative methods to assess their transport, metabolism and toxicity. New advanced "omics" technologies will allow "in vitro/in vivo" comparisons, produce reference standards for the validation of cellular models and develop high throughput technologies. A unit in charge of in silico pharmacokinetic studies will allow assessment of the utility of the developed in vitro models, from a predictive in vivo stance.