Safety as a determining factor in the pharmaceutical drug development for patients of the pediatric population

Abstract

Patients in the pediatric population are characterized by differences in the pharmacokinetics and pharmacodynamics of drugs and the range of acceptable dosage forms compared to adult patients. The development of safe drugs is designed to reduce the incidence of adverse reactions in this group. Aim. To highlight physiological features of the body of patients in the pediatric population, the corresponding differences in the pharmacological characteristics of drugs, and approaches to minimizing the risks of pharmacotherapy at the stage of pharmaceutical drug development. Materials and methods. Such general scientific theoretical methods as system analysis, generalization, and system approach, as well as the bibliographic method consisted in processing scientific sources of information on drug use in pediatrics and developing pediatric dosage forms were used. Results. When prescribing drugs to pediatric patients, the physiological features of the child’s body development should be considered, using a flexible approach to pharmacotherapy. Many drugs used in pediatrics have not been officially studied in pediatric clinical trials, and therefore, children often receive them off-label. The use of drugs in pediatrics requires special knowledge about the influence of age-related aspects of the child’s physiology on the absorption, distribution, metabolism and excretion of a drug, as well as on its interaction with receptors and organs. This article discusses approaches to the pharmaceutical development of drugs for use in the pediatric population. Conclusions. In pharmaceutical development of drugs for use in pediatric practice, it is necessary to keep in mind the features of drugs due to age and physiological factors in this category of patients, as well as to take into account the route of administration, the choice of the optimal dosage form, the safety profile of excipients, taste and ease of use of drugs. The development of new medicinal products, including multiparticulate solid dosage forms, is designed to improve the safety profile of drugs in children.