Specificity of Pharmacological and Toxicological Studies on Juvenile Animals

Abstract. With levels of medicine and pharmacology individualization constantly increasing, the scientific community is becoming seriously concerned about the safety of existing and developing drugs for the pediatric population insufficient assessment. The aim of this review is to analyze the main problems arising in the development and preclinical evaluation of drugs for children and adolescents, taking into account their age-related physiological and biochemical characteristics, as well as the selection of adequate juvenile experimental models among various animal species. Juvenile animal studies planning should be based on the specific age group of the pediatric population for which a specific drug is being developed. They cannot be conducted using standardized research protocols and require an individual approach in each specific case. Their design should include the study of drug effects at all ontogenesis stages, without exception, that correspond to the growth and development of the relevant pediatric population. Also fundamental are the correct choice of animal species, based on its sensitivity to the effects of the drug, the availability of relevant data from preclinical studies on adult animals and the planned procedures and types of studies, some of which can only be carried out on certain animal species. Pathologists should be able to compare tissue structures in parallel in an experiment, both normal and drug-treated, at all stages of ontogenesis, and have access to as many reference and image databases as possible. All of the above requirements are the minimum to ensure adequate support for clinical trials in the pediatric population.