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Minipigs as models for the toxicity testing of new medicines and chemicals: impact assessment

Objective

The RETHINK project will produce an impact assessment report on toxicity testing in the mini-pig as an alternative approach that can contribute to the replacement, refinement and reduction of animal testing (3Rs). The pig is close to man in terms of ana tomy, physiology and biochemistry and in consequence is an attractive model for safety evaluation and biomedical research, which may permit the replacement of dogs and monkeys and the more efficient and predictive use of biological resources and animal l ife. This promising approach is deserving of objective evaluation and this is the propitious moment, as legislation places greater emphasis on alternative approaches in safety evaluation (eg REACH initiative), and as toxicogenomics begins to make a cont ribution to safety issues. If the minipig is to provide a valid, realistic and robust alternative approach for use in the regulatory testing of new medicines and chemicals, while contributing to the 3Rs, there are issues that must be addressed in six div erse areas: (i) animal welfare, (ii) ethics, (iii) new medicines and chemicals development, (iv) validation of animals models in safety evaluation, (v) genomics and emerging technologies, and (vi) economic impact and overview issues. The Steering G roup (SG) of consortium members will assemble Working Groups (WG¿s) of recognised experts in each topic area and will provide WG¿s with methods to define a hierarchy of issues and develop responses. WG¿s will review and summarise the available body of kn owledge for their topic and prepare conclusions and recommendations, including identification of gaps in knowledge where further research is required, and technical gaps presenting obstacles to the use of minipigs. The WG documents will be finalised for a plenary meeting of experts, followed by editing into the final Impact Assessment report. The Impact Assessment will be made publicly available and disseminated to relevant stakeholders

Call for proposal

FP6-2004-LIFESCIHEALTH-5
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Funding Scheme

SSA - Specific Support Action

Coordinator

CENTRE INTERNATIONAL DE TOXICOLOGIE
Address
Miserey
Evreux
France

Participants (2)

ELLEGAARD GOTTINGEN MINIPIGS APS
Denmark
Address
Soroe Landevej 302
Dalmose
RIJKSINSTITUUT VOOR VOLKSGEZONDHEIT EN MILIEU
Netherlands
Address
Antonie Van Leeuwenhoeklaan, 9
Bilthoven