EXPERT EVALUATION OF PRECLINICAL STUDIES OF PRIMARY AND SECONDARY PHARMACODYNAMICS OF MEDICINES
Ведомости Научного центра экспертизы средств медицинского применения
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
... 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.