ANALYTICAL REVIEW OF THE NORMATIVE BASE TO PROVIDE THE GOOD QUALITY OF PRECLINICAL STUDIES IN RUSSIA

• Main Authors: A. I. Selezneva, S. V. Glembotsky, S. V. Polyakov, M. N. Makarova, V. G. Makarov, A. A. Churin
• Format: Article
• Language: Russian
• Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-01-01
• Series: Разработка и регистрация лекарственных средств
• Subjects: preclinical studies; drug development; quality
• Online Access: https://www.pharmjournal.ru/jour/article/view/438
• ISSN: 2305-2066; 2658-5049

The main goal of preclinical studiesis the development of effective, high-quality and safe drugs. The task of preclinical studiesis to obtain exhaustive information, reliable and reproducible results. The article presents an overview of modern normative documents regulating the quality of preclinical studies, focuses attentionon the most important information in these documents and gives recommendations to specialists. A careful and reasonable application of the rules, guidelines and implementation of requirements of regulatory documents by experts involved in the process of drug development, allow to obtain reliable, complete and qualitative results of preclinical studies. This is extremely important both for planning and conducting subsequent clinical trials, and for evaluation of the desirability of continuing the project of development.