Perfection of management principles by the safety signals of medicinal products

Systematic evaluation of management principles by signals on medicinal drugs safety is submitted. The sources of signals, the approaches to the detection signal processing and detection, validation, analysis and prioritization, signal assessment are considered. A review of the individual security re...

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Main Authors: B. K. Romanov, V. K. Lepakhin, E. O. Zhuravleva, A. V. Astakhova, S. V. Glagolev, V. A. Polivanov
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-02-01
Series:Безопасность и риск фармакотерапии
Subjects:
Online Access:https://www.risksafety.ru/jour/article/view/33
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author B. K. Romanov
V. K. Lepakhin
E. O. Zhuravleva
A. V. Astakhova
S. V. Glagolev
V. A. Polivanov
author_facet B. K. Romanov
V. K. Lepakhin
E. O. Zhuravleva
A. V. Astakhova
S. V. Glagolev
V. A. Polivanov
author_sort B. K. Romanov
collection DOAJ
description Systematic evaluation of management principles by signals on medicinal drugs safety is submitted. The sources of signals, the approaches to the detection signal processing and detection, validation, analysis and prioritization, signal assessment are considered. A review of the individual security reports is demonstrated. A statistical analysis of large databases and processes of their regulation was shown. Practical recommendations for the identification of signals in national and international databases are given.
format Article
id doaj-art-799f969b7f4c4172a6db89cdd3d5b62f
institution Kabale University
issn 2312-7821
2619-1164
language Russian
publishDate 2018-02-01
publisher Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
record_format Article
series Безопасность и риск фармакотерапии
spelling doaj-art-799f969b7f4c4172a6db89cdd3d5b62f2025-08-20T03:56:40ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642018-02-0101102033Perfection of management principles by the safety signals of medicinal productsB. K. Romanov0V. K. Lepakhin1E. O. Zhuravleva2A. V. Astakhova3S. V. Glagolev4V. A. Polivanov5Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsPeoples’ Friendship University of RussiaRoszdravnadzor of the Russian FederationCenter for Monitoring of Effective, Safety and Rational Use of Medicinal Products, Roszdravnadzor of the Russian FederationSystematic evaluation of management principles by signals on medicinal drugs safety is submitted. The sources of signals, the approaches to the detection signal processing and detection, validation, analysis and prioritization, signal assessment are considered. A review of the individual security reports is demonstrated. A statistical analysis of large databases and processes of their regulation was shown. Practical recommendations for the identification of signals in national and international databases are given.https://www.risksafety.ru/jour/article/view/33управлениесигналбезопасностьлекарственное средстволекарственный препаратфармаконадзорsignal managementmanagementsignalsafetydrugmedicinal products
spellingShingle B. K. Romanov
V. K. Lepakhin
E. O. Zhuravleva
A. V. Astakhova
S. V. Glagolev
V. A. Polivanov
Perfection of management principles by the safety signals of medicinal products
Безопасность и риск фармакотерапии
управление
сигнал
безопасность
лекарственное средство
лекарственный препарат
фармаконадзор
signal management
management
signal
safety
drug
medicinal products
title Perfection of management principles by the safety signals of medicinal products
title_full Perfection of management principles by the safety signals of medicinal products
title_fullStr Perfection of management principles by the safety signals of medicinal products
title_full_unstemmed Perfection of management principles by the safety signals of medicinal products
title_short Perfection of management principles by the safety signals of medicinal products
title_sort perfection of management principles by the safety signals of medicinal products
topic управление
сигнал
безопасность
лекарственное средство
лекарственный препарат
фармаконадзор
signal management
management
signal
safety
drug
medicinal products
url https://www.risksafety.ru/jour/article/view/33
work_keys_str_mv AT bkromanov perfectionofmanagementprinciplesbythesafetysignalsofmedicinalproducts
AT vklepakhin perfectionofmanagementprinciplesbythesafetysignalsofmedicinalproducts
AT eozhuravleva perfectionofmanagementprinciplesbythesafetysignalsofmedicinalproducts
AT avastakhova perfectionofmanagementprinciplesbythesafetysignalsofmedicinalproducts
AT svglagolev perfectionofmanagementprinciplesbythesafetysignalsofmedicinalproducts
AT vapolivanov perfectionofmanagementprinciplesbythesafetysignalsofmedicinalproducts