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Information System for Agriculture and Food Research

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3R methods for the replacement and improvement of legally required animal experiments in the testing of immunological drugs

Collaborative Project

Contract period: 01.08.2011 - 31.07.2014
Coordinating institution: Unit Pharmacovigilance of Veterinary Immunological Products and Animal Welfare

The project aims at introducing new test systems in animal assays required by law. The test systems are intended to bring about significant improvements with regard to 3Rs. Subproject (1) is designed to improve the tuberculin assay in guinea pigs step-by-step. This method is required in conformity with the pharmacopoeia. Beside the long-term replacement of the in vivo method, the project is also designed to analyse refinement approaches for the short-term use. Moreover, the general benefit of the the use of infrared thermography will be investigated in further laboratory animals used in tumour research and batch quality control testing of medicinal products with the aim of defining suitable clinical end points. Subproject (2) refers to safety testing of medicinal products in large animals required within the marketing authorisation procedure. The inclusion of computer tomography, ultrasound screening and infrared profiles of local inflammatory reactions will result in the chances to define new clinical criteria, thus leading to improvements in the testing conditions, which, in turn, will bring about a reduction in the number of animals used. The aim of subproject (3) is to apply new 3R methods for the manufacture of test antigens for the diagnosis of dourine, a venerial disease in horse. The subprojects are independent from each other, and each subproject forms a unit in its own right. The examination of uses of thermography as a diagnostic refinement method in serious inflammatory reactions is a feature common to all subprojects.

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