Perfection of management principles by the safety signals of medicinal products
Abstract
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.
About the Authors
B. K. Romanov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
V. K. Lepakhin
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
E. O. Zhuravleva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
A. V. Astakhova
Peoples’ Friendship University of Russia
Russian Federation
Russian Federation
S. V. Glagolev
Roszdravnadzor of the Russian Federation
Russian Federation
Russian Federation
V. A. Polivanov
Center for Monitoring of Effective, Safety and Rational Use of Medicinal Products, Roszdravnadzor of the Russian Federation
Russian Federation
Russian Federation
References
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Review
For citations:
Romanov B.K., Lepakhin V.K., Zhuravleva E.O., Astakhova A.V., Glagolev S.V., Polivanov V.A. Perfection of management principles by the safety signals of medicinal products. Safety and Risk of Pharmacotherapy. 2016;(1):10-20. (In Russ.)
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