Quality Assurance of Medicines: Main Scientific Approaches and Control Methods

The most important component of national health policy is the assurance of quality, efficacy, and safety of medicines entering the pharmaceutical market in the Russian Federation. In this interview, we have discussed the quality control of medicines; its interconnections with various branches of sci...

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Main Authors: E. L. Kovaleva, Yu. A. Zolotov, D. V. Somov
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2023-09-01
Series:Регуляторные исследования и экспертиза лекарственных средств
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Online Access:https://www.vedomostincesmp.ru/jour/article/view/578
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author E. L. Kovaleva
Yu. A. Zolotov
D. V. Somov
author_facet E. L. Kovaleva
Yu. A. Zolotov
D. V. Somov
author_sort E. L. Kovaleva
collection DOAJ
description The most important component of national health policy is the assurance of quality, efficacy, and safety of medicines entering the pharmaceutical market in the Russian Federation. In this interview, we have discussed the quality control of medicines; its interconnections with various branches of science, in particular, with analytical chemistry; and the matters of material and equipment supply with Elena L. Kovaleva (Doctor of Pharmaceutical Sciences, Deputy Director of the Centre for Medicinal Products Evaluation and Control of the Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation), Yuri A. Zolotov (Academician of the Russian Academy of Sciences, Full Professor, Doctor of Chemical Sciences), and Dmitry V. Somov (Candidate of Pharmaceutical Sciences, Acting Director General of the Information and Methodological Center for Expertise, Accounting, and Analysis of the Circulation of Medicinal Products of the Federal Service for Surveillance in Healthcare).
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institution Kabale University
issn 3034-3062
3034-3453
language Russian
publishDate 2023-09-01
publisher Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
record_format Article
series Регуляторные исследования и экспертиза лекарственных средств
spelling doaj-art-952e18e5880249b6b3b0cc4760a3d1cd2025-08-20T03:57:31ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532023-09-0113336837510.30895/1991-2919-2023-13-3-368-375409Quality Assurance of Medicines: Main Scientific Approaches and Control MethodsE. L. Kovaleva0Yu. A. Zolotov1D. V. Somov2Scientific Centre for Expert Evaluation of Medicinal ProductsLomonosov Moscow State UniversityInformation and Methodological Center for Expertise, Accounting and Analysis of the Circulation of Medicinal ProductsThe most important component of national health policy is the assurance of quality, efficacy, and safety of medicines entering the pharmaceutical market in the Russian Federation. In this interview, we have discussed the quality control of medicines; its interconnections with various branches of science, in particular, with analytical chemistry; and the matters of material and equipment supply with Elena L. Kovaleva (Doctor of Pharmaceutical Sciences, Deputy Director of the Centre for Medicinal Products Evaluation and Control of the Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation), Yuri A. Zolotov (Academician of the Russian Academy of Sciences, Full Professor, Doctor of Chemical Sciences), and Dmitry V. Somov (Candidate of Pharmaceutical Sciences, Acting Director General of the Information and Methodological Center for Expertise, Accounting, and Analysis of the Circulation of Medicinal Products of the Federal Service for Surveillance in Healthcare).https://www.vedomostincesmp.ru/jour/article/view/578quality controlmedicinesanalytical laboratoryanalytical equipmentreference standardscompendial methodsmethods of analysis
spellingShingle E. L. Kovaleva
Yu. A. Zolotov
D. V. Somov
Quality Assurance of Medicines: Main Scientific Approaches and Control Methods
Регуляторные исследования и экспертиза лекарственных средств
quality control
medicines
analytical laboratory
analytical equipment
reference standards
compendial methods
methods of analysis
title Quality Assurance of Medicines: Main Scientific Approaches and Control Methods
title_full Quality Assurance of Medicines: Main Scientific Approaches and Control Methods
title_fullStr Quality Assurance of Medicines: Main Scientific Approaches and Control Methods
title_full_unstemmed Quality Assurance of Medicines: Main Scientific Approaches and Control Methods
title_short Quality Assurance of Medicines: Main Scientific Approaches and Control Methods
title_sort quality assurance of medicines main scientific approaches and control methods
topic quality control
medicines
analytical laboratory
analytical equipment
reference standards
compendial methods
methods of analysis
url https://www.vedomostincesmp.ru/jour/article/view/578
work_keys_str_mv AT elkovaleva qualityassuranceofmedicinesmainscientificapproachesandcontrolmethods
AT yuazolotov qualityassuranceofmedicinesmainscientificapproachesandcontrolmethods
AT dvsomov qualityassuranceofmedicinesmainscientificapproachesandcontrolmethods