Zobrazeno 1 - 10
of 40
pro vyhledávání: '"R. Niyazov"'
Autor:
K. S. Radaeva, R. R. Niyazov
Publikováno v:
Реальная клиническая практика: данные и доказательства, Vol 3, Iss 3, Pp 20-27 (2023)
Real-world data and real-world evidence play an increasingly important role in clinical research and healthcare decisionmaking. To use data and generate robust evidence effectively, they must be clearly defined and structured, semantically compatible
Externí odkaz:
https://doaj.org/article/8793453764224f61b27066642e08a06a
Publikováno v:
Сахарный диабет, Vol 23, Iss 6, Pp 548-560 (2021)
Biosimilars are biological drug products that have an equivalent clinical profile with innovator biotherapeutics but are developed under a reduced program. To this end, specific comparability approaches are followed based on reverse engineering that
Externí odkaz:
https://doaj.org/article/3890df950eda4cfaab3a564c6fd838b2
Publikováno v:
Антибиотики и Химиотерапия, Vol 58, Iss 9-10, Pp 45-55 (2020)
Ensuring quality, safety and efficacy of the medicinal products placed on the market of the Russian Federation constitutes the area that requires strict regulation. When changes are made to the manufacturing process, the manufacturer generally needs
Externí odkaz:
https://doaj.org/article/b4b174a008d3430989665acda617b35e
Autor:
A. N. Vasilyev, D. V. Goryachev, E. V. Gavrishina, R. R. Niyazov, Yu. A. Seliverstov, A. V. Digtyar
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 0, Iss 2, Pp 15-23 (2018)
Since Ilya Metchnikoff’s studies, both medical science and clinical practice have accumulated a large amount of evidence that human intestinal microbiota possesses a unique characteristics for our existence. However, only recently, scientists have
Externí odkaz:
https://doaj.org/article/5aa7e4fa05f04e6a82851d73733c556d
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 0, Iss 3, Pp 3-7 (2018)
This paper presents an analysis of leading foreign regulatory authorities’ requirements for the bioequivalence studies of medicinal products containing analogues of endogenous substances. US Food and Drug Administration, European Medicines Agency,
Externí odkaz:
https://doaj.org/article/9f649c4049db4640853e827739d9d3d8
Autor:
D. P. Romodanovsky, T. V. Eremenkova, M. A. Dranitsyna, D. V. Goryachev, R. R. Niyazov, E. V. Gavrishina, V. A. Merkulov
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 0, Iss 4, Pp 5-10 (2018)
At present a specific group of medicines - highly variable medicines - is distinguished based on intraindividual variability data (CVintra > 30%). It is quite difficult to confirm therapeutic equivalence of highly variable medicines by pharmacokineti
Externí odkaz:
https://doaj.org/article/4dcfd83ba7e94e3aa7dc6a76b7d27a75
Publikováno v:
Remedium. :56-68
The legal framework for biosimilar medicinal product was first established in 2004 in the European Union and later in the USA. Since then, based on the scientific and regulatory experience with biosimilarity assessment, regulatory approaches have evo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0cc37cf0693fd3f354b5dfb0a070f65e
https://doi.org/10.21518/1561-5936-2021-3-56-68
https://doi.org/10.21518/1561-5936-2021-3-56-68
Publikováno v:
Genes & Cells. 15:104-110
The environment for the development of products containing live cells as an active substance is being set up in Russia for several years. However, the acceptable regulatory framework, which would have allowed to develop and place cell therapy product
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::aa39ed160805689f029558fcc90e60a6
https://doi.org/10.23868/202004014
https://doi.org/10.23868/202004014
Publikováno v:
Genes & Cells. 15:78-87
In the European Union and the United States, regulation of cell-based products for the placing on the market is rather extensive and multi-tiered. This is due to the complexities which emerge at the different steps of the process, e. g. when obtainin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::420314be28e1f134a81e55d4fe2d3c42
https://doi.org/10.23868/202003011
https://doi.org/10.23868/202003011
Publikováno v:
BMC Medical Ethics, Vol 22, Iss 1, Pp 1-8 (2021)
BMC Medical Ethics
BMC Medical Ethics
Background In modern Russia, any clinical investigation of a pharmaceutical for use in humans is subject to prior evaluation and approval by the Ministry of Health and its Central Ethics Committee. Despite this, some researchers and trial sponsors fa
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e3b042be26e68c9d176428558d954d87
https://doi.org/10.1186/s12910-021-00617-3
https://doi.org/10.1186/s12910-021-00617-3