EXPERT EVALUATION OF PRECLINICAL STUDIES OF PRIMARY AND SECONDARY PHARMACODYNAMICS OF MEDICINES

Abstract

The article dwells upon the results of comparative analysis of the Russian national requirements  and EAEU regulations dealing with evaluation of preclinical pharmacological studies. It highlights historical aspects of elaboration of regulatory requirements and scientific and methodological  recommendations for conducting  and evaluating preclinical pharmacological  studies. According to the EAEU Rules of registration and evaluation of medicinal products for human use, the Common  Technical Document has to include information  on primary pharmacodynamics, secondary pharmacodynamics, safety pharmacology  studies, and pharmacodynamic drug interactions, which are subject to evaluation  during examination  of the preclinical  study results. The national guideline on evaluation of medicines does not contain any clear indication of the subject of examination in primary and secondary pharmacodynamic studies, which can make it difficult to prepare a registration dossier in the format of a Common Technical Document. The article formulates basic approaches to expert evaluation of the results of preclinical studies of primary and secondary pharmacodynamics of medicines. It determines the basics of expert evaluation which covers methodological framework of the research, results of the research, characteristics of the safety profile, extrapolation  of preclinical data, characteristics of risk factors and of the predictable clinical safety profile for patients.