Использование собак в доклинических исследованиях

Abstract

According to local and international regulatory documents, in addition to rodent second non-rodent species are required to provide sufficient toxicological data. The most commonly the Beagle dog is used as the second non-rodent species. The wide use of Beagle dogs has become possible due to a number of advantages of this breed: medium size, balanced temperament, friendliness, relative ease of handling. Recently, the use of dogs in preclinical studies has been declining for humanitarian reasons. If there is no alternative to the use of dogs, every effort must be made to implement the principles of the 3Rs in experimental practice. Reducing the number of animals in the experiment can be achieved through the use of combined experimental designs, when additional parameters (safety pharmacology, immunotoxicity, reproductive toxi­city, pharmacokinetic) are included in the main toxicological study. Long-term toxicity studies (9 months) are required for drugs with planned long-term clinical use, while shorter studies (3 months, 6 months) may be needed to support the first phases of clinical studies. Instead of conducting several toxicity studies, one long-term study may be considered, without interim euthanasia (3 or 6 months of drug administration), but at these points the biomarkers are evaluated, the range of which is similar to those evaluated in clinical studies. During the long-term use of Beagles in biomedical research, data on the physiology, biochemistry, and morphology of this breed have been accumulated. The use of the available literature data as well as the available laboratory historical data also makes it possible to reduce the number of animals in the experiment, for example by reducing the number of animals in the control groups and in the recovery groups. Preliminary analysis of the available scientific data on the test compound or on analogous compounds may lead to the reduction of animals in the experiment without compromising the clinical safety. In addition, due to the scientifically based approach and careful design of the experiment, euthanasia of all animals in the experiment can be avoided. Laboratory dogs are often rehomed nowadays into private households after their use in research.