V.V. Bortnikova - Ph.D. (Biol.), Head of the Laboratory Drug Toxicology, All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (VILAR). E-mail: bortnikova.v@yandex.ru
L.V. Krepkova - Ph.D. (Biol.), Head of Toxicology Department, All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (VILAR). E-mail: krepkowa2011@yandex.ru
T.A. Guskovа - Honored Scientist of Russian Federation, Corresponding Member of the Russian Corr. Russian Academy of Medical Sciences, Dr.Sc.(Med.), Professor, Head of the Department of Evaluation of the Effectiveness and Safety of Drugs NP SP «Scientific center of quality control (NP NW НЦКК). E-mail: tagus@rambler.ru

The necessity of preclinical safety study medication recommended for Pediatrics. Proposed methodological approaches for the study of General toxic action of pharmacological substances offered for paediatric practice, included in «The guidelines for conducting preclinical research of medicines»published in 2012 under the editorship of doctor of medical Sciences A.N. Mironov. According to these recommendations, all medicines for use in children, must undergo mandatory preclinical research on emerging animals of different age groups, age-appropriate. Depending on the goals and objectives of the experiments conducted on rats, small rabbits or puppies. Evaluate the toxicity of the drug at single and long-term administration to animals with a daily registration of the basic integral indices study of peripheral blood and functional status of the main organs and systems of organism andpathohistological study. Special attention is given to study safety of medications intended for use in neonates and premature infants. For these purposes in the experiment the use of rats 2-3 days of age, which drugs are administered parenterally or externally. During subchronicor chronic experiment assess the physical development of the young rats (eyes opening, fouling wool) and maturation of sensory-motor reflexes (flipping on a plane, avoiding breakage). In the end of the experiment conduct hematological, biochemical and pathohistological studies, assess the state of the Central nervous system and cognitive functions of rats. On the basis of the obtained data give recommendations on the feasibility of conducting clinical research on children. An important moment in the safety evaluation of drugs for children is to compare the Toxicological parameters obtained in the experiments on Mature and immature animals of various ages. While there was no difference in the sensitivity of the organs to the preparation of Mature and immature animals can be more confident about the acceptability of the drug in Pediatrics. Such an approach to assessing the safety of medicines intended for Pediatrics should be considered mandatory because it allows more likely to predict the safety and tolerability of drugs in children.