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Rational Pharmacotherapy in Cardiology

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Registration of Medicines in the Soviet Control and Licensing System on the Example of the Cardiological Drug Trinitrolong

https://doi.org/10.20996/1819-6446-2021-02-06

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Abstract

The article presents the history of the study and registration in the USSR of the buccal form of nitroglycerin (trinitrolong) in the 1970s and 1980s, based on a number of author's publications, documentary evidence and oral stories of participants in clinical trials. The specifics of the passage of the main stages of registration of a new pharmacological agent in the Soviet control and authorization system from the author's idea to the introduction of the drug into clinical practice are described. Some reasons for the lag of the USSR from the countries of the capitalist West in the development and introduction of new cardiac drugs are analyzed.

About the Authors

A. N. Petrenko
Siberian State Medical University
Russian Federation

Alexander N. Petrenko

Tomsk

eLibrary SPIN: 3212-8410



P. A. Vasiliev
St. Petersburg Branch of the Federal State Autonomous Educational Institution of Higher Education National Research University Higher School of Economics
Russian Federation

Pavel A. Vasilyev

St. Petersburg

eLibrary SPIN: 9272-6731



S. Yu. Martsevich
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Sergey Yu. Martsevich

Moscow

eLibrary SPIN: 7908-9554



N. P. Kutishenko
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Natalia P. Kutishenko

Moscow

eLibrary SPIN: 7893-9865



O. I. Zvonareva
Siberian State Medical University
Russian Federation

Olga I. Zvonareva

Tomsk

eLibrary SPIN: 9145-4513



References

1. Metelitsa V. I. Pages of life. Moscow: Raduga; 2001 (In Russ.)

2. Russian State Archive of Scientific and Technical Documentation Fund 236 Inventory 1-1 File 2924 (In Russ.)

3. Babayan E. A. The main provisions of the approbation of medicines in the USSR and foreign countries. Moscow: Medicine; 1982 (In Russ.)

4. Metelitsa V.I., Davydov A.B. Nitrate preparations in cardiology. Moscow: Medicine; 1989 (In Russ.)

5. Metelitsa V.I. Handbook of clinical pharmacology of cardiovascular drugs. 3rd ed., revised and enlarged. Moscow: Medical information agency (MIA) 2005, P. 1536 (In Russ.)


For citation:


Petrenko A.N., Vasiliev P.A., Martsevich S.Yu., Kutishenko N.P., Zvonareva O.I. Registration of Medicines in the Soviet Control and Licensing System on the Example of the Cardiological Drug Trinitrolong. Rational Pharmacotherapy in Cardiology. 2021;17(1):133-139. (In Russ.) https://doi.org/10.20996/1819-6446-2021-02-06

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ISSN 1819-6446 (Print)
ISSN 2225-3653 (Online)