Approaches to Drug Pharmacokinetics Study Design in Preclinical Trials (Review)

INTRODUCTION . According to drug registration requirements, a registration dossier should include the data on preclinical trials of drug pharmacokinetics. However, the scope of data provided for various drugs groups, as well as pharmacokinetics elements to be studied at each stage of the product life cycle is still a relevant issue. AIM . This study aimed to analyze literature data, Russian and foreign guidelines on preclinical trials of drug pharmacokinetics to choose an optimal strategy of data collection at various stages of drug life cycle. DISCUSSION . The research materials included regulatory documents, guidelines on preclinical trials, scientific articles and other publicly available sources (including electronic RSCI databases (eLIBRARY.RU), PubMed, and Web of Science). We analyzed the main approaches to planning pharmacokinetic trials for various drugs (original, generic, biological drugs, etc.), including the type and number of laboratory animals, the doses studied and the time points of biomaterial sampling. CONCLUSIONS . Preclinical pharmacokinetic trials are warranted for optimization of active pharmaceutical substance molecules, selection of the dosage form to study various drug groups, predicting pharmacokinetic parameters in humans, reducing time costs and risks when developing safe and effective drugs. Designs of pharmacokinetic trials were proposed at the stage of molecule screening, molecule optimization and selection of the drug forms for the research of various drug groups.