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2022: Opening of the first narrow-profile laboratory of pharmaceutical research in Russia
In June 2022, the Center for Pharmaceutical Analytics, with the support of the Department of Entrepreneurship and Innovative Development of the city of Moscow, in the presence of representatives of the NCESMP, opened the first narrow-profile research laboratory for pharmaceutical research (LFI) in Skolkovo.
The area of the institution is 156 square meters. m, there it is planned to annually conduct about 100 studies of drugs at various stages of their life cycle.
The activity profile of the LFI is a classic dissolution kinetics test and the "biovaver" procedure. The latter is used when registering additional dosages, and may also replace bioequivalence studies for BCS class 1 and 3 products. According to the requirements of Decision No. 85 "On Approval of the Rules for Conducting Bioequivalence Studies of Medicinal Products within the Framework of the Eurasian Economic Union," the results of the biovaver procedure are submitted to the documents when submitting the registration dossier for reproduced medicines for examination.
 | The experience of laboratory employees in developing the design and carrying out the "biovaver" procedure is facilitated by the Decree of the Government of the Russian Federation of April 5, 2022 No. 593 "On the peculiarities of circulation of medicines for human use in the event of defects or the risk of defects in drugs in connection with the introduction of restrictive measures of an economic nature in relation to the Russian Federation," said Elizabeth Fisher, head of the pharmaceutical research laboratory. |  |
According to the press service of the Skolkovo Technopark, the opening of a narrow-profile laboratory in the Russian capital is an integral process of ensuring the technological sovereignty of the country's pharmaceutical industry. As the director of the center for the transfer of medical technologies of the Federal State Budgetary Institution "NCESMP" of the Ministry of Health of Russia Konstantin Belanov noted, the opening of the LFI is a good step to improve the quality of research carried out precisely at the early stages of drug development for the purpose of subsequent registration.[1]
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