FEATURES OF THE ORGANIZATION OF CLINICAL TRIALS OF NARCOTIC DRUGS IN RUSSIA
G. N. Gildeeva,
E. A. Ezhova,
D. V. Butuzova,
N. L. Mishchenko,
V. Y. Yurkov,
A. V. Teteneva,
T. S. Ageeva https://doi.org/10.29001/2073-8552-2019-34-2-152-158
Abstract
The problem of ensuring the necessary level of availability of narcotic drugs (NLP) in the Russian Federation, especially in the framework of palliative medical care for oncological patients is the area of special and constant attention of the Government and civil society. Recently, a number of necessary changes of the legislation aimed at simplifying the procedures for prescribing and issuing NLP have been introduced, and the possibility of optimizing the rules for their storage and accounting as well as improving the methods for calculating the needs for such drugs are being actively discussed.
As part of the import substitution program in Russia, the new dosage forms for NLP are under development. Such process is accompanied by clinical studies with a number of features that take into account the specific chemical composition of finished products.
About the Authors
G. N. Gildeeva
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation
Russian Federation
Dr. Sci. (Pharm.), Professor of the Organization and Management in the Field of Drugs Circulation Department
8 bld. 2, Trubetskaya str., Moscow, Russian Federation
E. A. Ezhova
Federal State Unitary Enterprise “Moscow Endocrine Plant”
Russian Federation
Russian Federation
First Deputy General Director
25, Novokhokhlovskaya str., Moscow, Russian Federation
D. V. Butuzova
Medical Development Agency LLC
Russian Federation
Russian Federation
Head of Clinical Research Department
office 803.6; 1,Vasilisy Kozhinoi str., Moscow, Russian Federation
N. L. Mishchenko
Medical Development Agency LLC
Russian Federation
Russian Federation
Quality Assurance Manager
office 803.6; 1,Vasilisy Kozhinoi str., Moscow, Russian Federation
V. Y. Yurkov
Medical Development Agency LLC
Russian Federation
Russian Federation
Cand. Sci. (Biol.), Medical Advisor, Clinical Research Department
office 803.6; 1,Vasilisy Kozhinoi str., Moscow, Russian Federation
A. V. Teteneva
Siberian State Medical University
Russian Federation
Russian Federation
Dr. Sci. (Med.), Associate Professor of the Department of Propaedeutics of Internal Diseases with a Course of Therapy of Pediatric Faculty
2, Moskovsky trakt, Tomsk, 634050, Russian Federation
T. S. Ageeva
Siberian State Medical University
Russian Federation
Russian Federation
Dr. Sci. (Med.), Professor, Head of the Department of Propaedeutics of Internal Diseases with a Course of Therapy of Pediatric Faculty
2, Moskovsky trakt, Tomsk, 634050, Russian Federation
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Review
For citations:
Gildeeva G.N., Ezhova E.A., Butuzova D.V., Mishchenko N.L., Yurkov V.Y., Teteneva A.V., Ageeva T.S. FEATURES OF THE ORGANIZATION OF CLINICAL TRIALS OF NARCOTIC DRUGS IN RUSSIA. Siberian Journal of Clinical and Experimental Medicine. 2019;34(2):152-158. (In Russ.) https://doi.org/10.29001/2073-8552-2019-34-2-152-158
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