Zobrazeno 1 - 10
of 16
pro vyhledávání: '"R. 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:
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:
Bulletin of Experimental Biology and Medicine. 158:450-452
We compared anti-IIa activity of a heparin analogue and a reference product was carried out to confirm their biosimilarity. The experiment was based on the method of estimation of anti-IIa activity of a commercial sodium heparin preparation according
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::daf7440bcdabb3f2aef0f9520a36648b
https://doi.org/10.1007/s10517-015-2782-3
https://doi.org/10.1007/s10517-015-2782-3
Autor:
Lilia E. Ziganshina, R R Niyazov
Publikováno v:
Kazan medical journal. 94:240-244
The review surveys the problems of pharmaceutical promotion and public health. Global and domestic realities of pharmaceutical marketing are discussed. Various promotional activities of pharmaceutical industry are described with special emphasis on j
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f16b3f62dc61209d6572554a63474825
https://doi.org/10.17816/kmj1596
https://doi.org/10.17816/kmj1596
Publikováno v:
Kazan medical journal. 94:95-100
The review covers the history and evolution of the WHO initiatives in pharmaceutical policy - for better and safer use of medicines, their scientifically based selection and ethical promotion. The WHO Concept of Essential Medicines, the WHO vision of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b8b1282dd0c81d8554876fc67b40af4e
https://doi.org/10.17816/kmj1779
https://doi.org/10.17816/kmj1779