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Optimisation of liver and intestine in vitro model for pharmacokinetics and pharmacodynamics studies

Optimisation of liver and intestine in vitro model for pharmacokinetics and pharmacodynamics studies

Objective

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.

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Coordinator

CONSIGLIO NAZIONALE DELLE RICERCHE

Address

Piazzale Aldo Moro, 7
Roma

Italy

Administrative Contact

Maria Flavia ZUCCO (Dr)

Participants (14)

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ENTE OSPEDALIERO CANTONALE/ISTITUTO ONCOLOGICO DELLA SVIZZERA ITALIANA

Switzerland

FONDACION HOSPITAL UNIVERSITARIO DE LA FE

Spain

BIOPREDIC INTERNATIONAL SARL

France

HELSINGIN YLIOPISTO

Finland

THE UNIVERSITY OF MANCHESTER

United Kingdom

ISTITUTO NAZIONALE DI RICERCA PER GLI ALIMENTI E LA NUTRIZIONE

Italy

VRIJE UNIVERSITEIT BRUSSEL

Belgium

NOVAMASS ANALYTICAL OY

Finland

NV ORGANON

Netherlands

SIMCYP LIMITED

United Kingdom

SIENA BIOTECH SPA

Italy

ADVANCED IN VITRO CELL TECHNOLOGIES

Spain

SOLVO BIOTECHNOLOGY

Hungary

INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE

France

Project information

Grant agreement ID: 37499

  • Start date

    1 January 2007

  • End date

    30 June 2010

Funded under:

FP6-LIFESCIHEALTH

  • Overall budget:

    € 4 312 111

  • EU contribution

    € 2 933 291

Coordinated by:

CONSIGLIO NAZIONALE DELLE RICERCHE

Italy