Current Requirements for and Approaches to Dosing in Animal Studies

• Main Authors: A. V. Rybakova, M. N. Makarova, A. E. Kukharenko, A. S. Vichare, F. R. Rueffer
• Format: Article
• Language: Russian
• Published: OOO “Vashe Tsifrovoe Izdatelstvo” 2018-12-01
• Series: Ведомости Научного центра экспертизы средств медицинского применения
• Subjects: administered volume; dosing; laboratory animals; well-being of laboratory animals; humane treatment of laboratory animals
• Online Access: https://www.vedomostincesmp.ru/jour/article/view/163

Today, within the context of harmonisation of requirements in the international pharmaceutical market, there is a trend towards development of common standards, including in the field of preclinical studies. The reliability and reproducibility of experimental data obtained in various laboratories using animals cannot be guaranteed unless the 3Rs principles are observed (the principles of humane experimental technique) to ensure the welfare of animals. The present paper analyses Russian and foreign recommendations on different administration routes and administered volumes as applied to mice, rats, guinea pigs, and rabbits – the most frequently used laboratory animals.  The paper systematises literature data on oral/intragastric, subcutaneous, intramuscular, intravenous and intraperitoneal routes of administration. It assesses potential complications of each route of administration, and negative effects on both health and well-being of laboratory animals, as well as on the results of experiments. The paper also touches upon some anatomical and physiological characteristics of laboratory animals, potential opportunities for feed and water deprivation, ways of reducing pain in animals. The results of comparison of administered volumes helped to determine optimal recommended and maximum administered volumes.