Zobrazeno 1 - 10
of 96
pro vyhledávání: '"E. V. Melnikova"'
Publikováno v:
Ведомости Научного центра экспертизы средств медицинского применения, Vol 14, Iss 1, Pp 29-41 (2024)
SCIENTIFIC RELEVANCE. Currently, the Russian Federation lacks a comprehensive regulatory framework for the use of gene and cell therapy (GCT) products. There is no standard for conducting clinical trials for purposes other than marketing authorisatio
Externí odkaz:
https://doaj.org/article/e4c8c599afe444d8af64fbd6bb57c473
Publikováno v:
Разработка и регистрация лекарственных средств, Vol 12, Iss 4, Pp 217-222 (2023)
Introduction. The quality of viable cell-based products (such as biomedical cell products and advanced therapy medicinal products) must be maintained during the full production cycle to ensure their safety and efficacy for patients. The minimum requi
Externí odkaz:
https://doaj.org/article/75f939670fb84973bc4f444c7f3a9d5b
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 23, Iss 3, Pp 247-261 (2023)
Scientific relevance. To date, multiple approaches to genome editing have been developed based on different genome-editing systems (GESs) and genome modifications that result in single- or double-strand DNA breaks, either in vivo or ex vivo, followed
Externí odkaz:
https://doaj.org/article/e38f3564540746a9b9395b9a626b1dc0
Autor:
M. A. Vodyakova, O. A. Rachinskaya, N. S. Pokrovsky, I. S. Semenova, E. V. Melnikova, V. A. Merkulov
Publikováno v:
Разработка и регистрация лекарственных средств, Vol 12, Iss 3, Pp 104-110 (2023)
Introduction. Identity is an important quality attribute of products containing viable human cells, to be tested during the quality control. The verification of identity includes, among other things, determination of the proliferative activity of the
Externí odkaz:
https://doaj.org/article/05541acf31f5429a81d3e61ab21e9ee2
Publikováno v:
Ведомости Научного центра экспертизы средств медицинского применения, Vol 13, Iss 2-1, Pp 248-260 (2023)
Somatic cell genome-editing systems are the most recent gene therapy technology to treat patients with monogenic hereditary cancer or HIV. Gene editing allows for changing or completely removing a defective gene with regularly interspaced short palin
Externí odkaz:
https://doaj.org/article/c651a2989ca1416d948e6dfe0f8b0632
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 23, Iss 2, Pp 127-147 (2023)
Neurodegenerative diseases (NDDs) are promising objects for the development of gene therapy products, primarily, due to the possible cause of these diseases (disruption of a gene or several genes), lack of effective therapy, and negative impact on th
Externí odkaz:
https://doaj.org/article/116343dbca824d7ab63b9fc3b0f3d04d
Publikováno v:
Фармация и фармакология (Пятигорск), Vol 10, Iss 6, Pp 515-524 (2023)
The aim of the study was to research the international experience in quality assurance of the products based on skin cells in order to identify the features of the quality control strategy in the development, production, as well as during an expert q
Externí odkaz:
https://doaj.org/article/aa98474882354cb5a9d57735d6655c87
Publikováno v:
Онкогематология, Vol 0, Iss 1, Pp 21-28 (2022)
Peripheral neuropathy is one of the most common complications of Bortezomib treatment. In this article you can find a brief literature review and single center experience: we estimated the prevalence of neuropathy development and it’s characteristi
Externí odkaz:
https://doaj.org/article/2fe1fc5297b94a8cb1ce434af387a255
Publikováno v:
Ведомости Научного центра экспертизы средств медицинского применения, Vol 11, Iss 4, Pp 218-227 (2021)
The only oncolytic virus-based product authorised in the US and EU—IMLYGIC®, a genetically modified herpes simplex virus type 1 (by BioVex Inc., a subsidiary of Amgen, Inc.)—was developed and approved for clinical use as monotherapy for recurren
Externí odkaz:
https://doaj.org/article/4ee1475eb2824c95bf4a6ca89492f8fe
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 21, Iss 3, Pp 167-177 (2021)
Current challenges to healthcare, i.e. the emergence of new diseases, lack of therapies for known diseases and life-threatening conditions, identification of patients who do not respond to standard treatment, on the one hand, and the evolution of sci
Externí odkaz:
https://doaj.org/article/79e27e7b918a4a48b2a62a1ad9d7c211