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
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. PetrenkoRussian Federation
Alexander N. Petrenko
Tomsk
eLibrary SPIN: 3212-8410
P. A. Vasiliev
Russian Federation
Pavel A. Vasilyev
St. Petersburg
eLibrary SPIN: 9272-6731
S. Yu. Martsevich
Russian Federation
Sergey Yu. Martsevich
Moscow
eLibrary SPIN: 7908-9554
N. P. Kutishenko
Russian Federation
Natalia P. Kutishenko
Moscow
eLibrary SPIN: 7893-9865
O. I. Zvonareva
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.)
Review
For citations:
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