publication . Article . 2018

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

Engalycheva, G. N.; Subaev, R. D.; Gorachev, D. V.; Olefir, Yu. V.;
Open Access Russian
  • Published: 26 Sep 2018 Journal: Ведомости Научного центра экспертизы средств медицинского применения, volume 8, issue 3, pages 138-144 (issn: 1991-2919, eissn: 2619-1172, Copyright policy)
  • Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”
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 ...
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Subjects
free text keywords: medicinal products, primary pharmacodynamics, secondary pharmacodynamics, preclinical pharmacological studies, expert criteria, interpretation of research results, lcsh:Medicine (General), lcsh:R5-920, Clinical safety, Medical physics, medicine.medical_specialty, medicine, SECONDARY PHARMACODYNAMICS, Expert evaluation, Technical documentation, business.industry, business, PRIMARY PHARMACODYNAMICS, Common Technical Document, Pharmacodynamics, Human use
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