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

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 passag...

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Main Authors:	A. N. Petrenko, P. A. Vasiliev, S. Yu. Martsevich, N. P. Kutishenko, O. I. Zvonareva
Format:	Article
Language:	English
Published:	Stolichnaya Izdatelskaya Kompaniya 2021-03-01
Series:	Racionalʹnaâ Farmakoterapiâ v Kardiologii
Subjects:	clinical trials buccal dosage form nitroglycerin trinitrolong drug registration
Online Access:	https://www.rpcardio.com/jour/article/view/2398

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spelling	doaj-ab25baa9d8084937a24582dce99dc3052021-09-03T13:15:32ZengStolichnaya Izdatelskaya KompaniyaRacionalʹnaâ Farmakoterapiâ v Kardiologii1819-64462225-36532021-03-0117113313910.20996/1819-6446-2021-02-061850Registration of Medicines in the Soviet Control and Licensing System on the Example of the Cardiological Drug TrinitrolongA. N. Petrenko0P. A. Vasiliev1S. Yu. Martsevich2N. P. Kutishenko3O. I. Zvonareva4Siberian State Medical UniversitySt. Petersburg Branch of the Federal State Autonomous Educational Institution of Higher Education National Research University Higher School of EconomicsNational Medical Research Center for Therapy and Preventive MedicineNational Medical Research Center for Therapy and Preventive MedicineSiberian State Medical UniversityThe 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.https://www.rpcardio.com/jour/article/view/2398clinical trialsbuccal dosage formnitroglycerintrinitrolongdrug registration
collection	DOAJ
language	English
format	Article
sources	DOAJ
author	A. N. Petrenko P. A. Vasiliev S. Yu. Martsevich N. P. Kutishenko O. I. Zvonareva
spellingShingle	A. N. Petrenko P. A. Vasiliev S. Yu. Martsevich N. P. Kutishenko O. I. Zvonareva Registration of Medicines in the Soviet Control and Licensing System on the Example of the Cardiological Drug Trinitrolong Racionalʹnaâ Farmakoterapiâ v Kardiologii clinical trials buccal dosage form nitroglycerin trinitrolong drug registration
author_facet	A. N. Petrenko P. A. Vasiliev S. Yu. Martsevich N. P. Kutishenko O. I. Zvonareva
author_sort	A. N. Petrenko
title	Registration of Medicines in the Soviet Control and Licensing System on the Example of the Cardiological Drug Trinitrolong
title_short	Registration of Medicines in the Soviet Control and Licensing System on the Example of the Cardiological Drug Trinitrolong
title_full	Registration of Medicines in the Soviet Control and Licensing System on the Example of the Cardiological Drug Trinitrolong
title_fullStr	Registration of Medicines in the Soviet Control and Licensing System on the Example of the Cardiological Drug Trinitrolong
title_full_unstemmed	Registration of Medicines in the Soviet Control and Licensing System on the Example of the Cardiological Drug Trinitrolong
title_sort	registration of medicines in the soviet control and licensing system on the example of the cardiological drug trinitrolong
publisher	Stolichnaya Izdatelskaya Kompaniya
series	Racionalʹnaâ Farmakoterapiâ v Kardiologii
issn	1819-6446 2225-3653
publishDate	2021-03-01
description	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.
topic	clinical trials buccal dosage form nitroglycerin trinitrolong drug registration
url	https://www.rpcardio.com/jour/article/view/2398
work_keys_str_mv	AT anpetrenko registrationofmedicinesinthesovietcontrolandlicensingsystemontheexampleofthecardiologicaldrugtrinitrolong AT pavasiliev registrationofmedicinesinthesovietcontrolandlicensingsystemontheexampleofthecardiologicaldrugtrinitrolong AT syumartsevich registrationofmedicinesinthesovietcontrolandlicensingsystemontheexampleofthecardiologicaldrugtrinitrolong AT npkutishenko registrationofmedicinesinthesovietcontrolandlicensingsystemontheexampleofthecardiologicaldrugtrinitrolong AT oizvonareva registrationofmedicinesinthesovietcontrolandlicensingsystemontheexampleofthecardiologicaldrugtrinitrolong
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Registration of Medicines in the Soviet Control and Licensing System on the Example of the Cardiological Drug Trinitrolong

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