Respect for animals and responsibility to people - Intervet International
25 June 2005
Veterinary medicinal products, both biologicals and pharmaceuticals, are subject to a rigorous registration system, which includes animal testing to demonstrate the safety and efficacy of the product prior to approval by Regulatory Authorities. Intervet actively supports and runs initiatives to reduce, refine and replace animal testing by alternative methods, to validate alternative tests and to obtain approval for such procedures from all authorities involved.
Veterinary vaccines have to undergo potency and safety testing before a batch can be released onto the market. Intervet collaborates in international studies to reduce the number of tests and animals required for potency testing, to establish international reference preparations allowing the development of in vitro potency tests and participated in a collaborative study which established a new in vitro serological assay to replace an animal challenge test for a bacterial vaccine. Intervet is currently cooperating with ECVAM (European Centre for the Validation of Alternative Methods, ISPRA, Italy) on several vaccines projects. In addition, Intervet is running more than ten internal projects dedicated to the development of in vitro potency testing for inactivated animal vaccines. Intervet has provided data to regulatory authorities with the objective to omit standard animal batch safety tests for a range of vaccines.
For pharmaceutical like antiparasitics and anti-infectives Intervet makes use of modern mechanism-based drug discovery mainly. Today it is possible to identify targets highly selective for the pathogen and screen with in vitro assays large compound libraries. Drug design and in vitro drug binding studies are possible with the nowadays-available structural information. This target-based approach enables an optimization of a candidate compounds in an early stage of drug discovery and is leading to highly selective and more advanced anti-infectives and antiparasitics entering the animal testing phase.
Intervet has spent great efforts to implement and refine in vitro assays which enable a meaningful selection of drug candidates at an early stage: i) in vitro toxicity assays and structural alert systems are used to predict potential toxicity risks in the animal, ii) in vitro methods to assess the bioavailability of potential drug candidates - a pre-requisite for activity in the animal, iii) in vitro assays to predict in vivo activity of a compound (BioScreens), well-known in the field of anti-infective testing, have been established and refined for a broad range of ecto- and endoparasites. These assays help to select the most promising drug candidates for further profiling and thereby minimize the number of drug candidates entering the animal testing phase.
Furthermore combining or modeling existing data on the in vitro activity (pharmacodynamics) with data on the behavior of a compound in the animal (pharmacokinetics) leads to a dose recommendation for efficacy testing of the drug in the animal. This reduces the number of studies for dose determination.
Intervet also supports initiatives from third parties with a newly established international animal welfare award: the Dieter Lütticken Award. The award, worth
€ 20,000, will be given annually to scientists or institutions that have delivered excellent contributions to the 3Rs (replacement, refinement and reduction of animal studies) for the development and production of veterinary medicinal products.
In 2005 the award goes to Prof. Andrew Hemphill, University of Bern, Institute of Parasitology, Faculty of Veterinary Medicine for the development and evaluation of in vitro approaches for culture and investigation of helminthic and protozoan parasites, in particular Neospora caninum and Echinococcus multilocularis. The award will be presented at a ceremony in conjunction with the "5th World Congress on Alternatives", August 21st–25th, 2005, Berlin, Germany.
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