Zobrazeno 1 - 10
of 61
pro vyhledávání: '"non-clinical studies"'
Autor:
Saki Yokoshiki, Teruyo Arato
Publikováno v:
Orphanet Journal of Rare Diseases, Vol 19, Iss 1, Pp 1-12 (2024)
Abstract Background The nonclinical as well as clinical development of orphan drugs is difficult, owing to unknown pathophysiology and the absence of animal models. Both, the U.S. Food and Drug Administration (FDA) Guidance and European Medicines Age
Externí odkaz:
https://doaj.org/article/747077eee2d04d2a879d408591b15d6f
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 4, Pp 423-429 (2023)
Scientific relevance. Favipiravir is an antiviral RNA polymerase inhibitor used to treat COVID-19. An adverse drug reaction associated with the use of favipiravir is renal disorder.Aim. This study aimed to investigate favipiravir nephrotoxicity by as
Externí odkaz:
https://doaj.org/article/ab94cd0ba4254feea1a60b46ec074b98
Autor:
A. V. Pogrebnyak
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 4, Pp 367-371 (2023)
The computational methods presently united by the concept of artificial intelligence began to form almost at the time of the emergence of mathematics. In recent decades, artificial intelligence has gained tremendous momentum and has become actively u
Externí odkaz:
https://doaj.org/article/a42659f92eb84f519f676aa49b6f1608
Autor:
A. A. Spasov
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 3, Pp 246-251 (2023)
It is strategically critical to secure pharmaceutical independence for Russia by developing the industry using the latest achievements in science and technology. The development of nationally and internationally competitive medicines calls for the ha
Externí odkaz:
https://doaj.org/article/dd3aa4ee8df345779b73859ad50ebaa1
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 23, Iss 2, Pp 148-161 (2023)
At present, personalised cellular immunotherapy is considered a promising approach to the treatment of malignant neoplasms. The effectiveness of these cellular immunotherapy methods is evaluated in the context of clinical and biological tumour charac
Externí odkaz:
https://doaj.org/article/99a3a96a6e7f4801891b8b4185e244a0
Autor:
I. A. Mazerkina
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 2, Pp 131-144 (2023)
Drug-induced liver injury (DILI) is the reason for 15–18% of medicinal product recalls from the market. Since interspecies differences often limit the relevance of standard non-clinical tests in vivo, a promising alternative is to develop cell-base
Externí odkaz:
https://doaj.org/article/ac9a3258dd264805a6b94a306344ff27
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 23, Iss 1, Pp 7-25 (2023)
Vaccines are subject to specific regulatory requirements for the evaluation of their quality, safety, and efficacy. In 2005, the World Health Organisation (WHO), as the main international organisation coordinating measures to combat infectious diseas
Externí odkaz:
https://doaj.org/article/a6ada49ddbeb4215b4a68527cc963ec7
Autor:
A. Yu. Grishina, U. V. Sharkova, Yu. I. Sysoev, D. Yu. Ivkin, I. A. Nikitina, N. A. Anisimova, V. P. Ilnitskiy, E. I. Eletskaya, S. V. Okovityi
Publikováno v:
Ведомости Научного центра экспертизы средств медицинского применения, Vol 13, Iss 1, Pp 51-59 (2023)
The humane treatment of laboratory animals is an integral part of good laboratory practice. It remains relevant to study the anaesthetic effects of various medicinal products helping to reduce pain and distress in laboratory animals.The aim of the st
Externí odkaz:
https://doaj.org/article/556fc168559e49efa2f09727c9374db5
Autor:
O. V. Astapova, A. A. Berchatova
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 1, Pp 73-96 (2023)
Currently, gene therapy medicinal products (GTMPs) are actively developed in many countries, including the Russian Federation. However, the use of GTMPs raises class-specific safety concerns.The aim of the study was to determine the main requirements
Externí odkaz:
https://doaj.org/article/5936e20468fe412082e1ae9a2a4b5961
Autor:
G. N. Engalycheva, R. D. Syubaev
Publikováno v:
Ведомости Научного центра экспертизы средств медицинского применения, Vol 13, Iss 1, Pp 14-26 (2023)
The lack of approved paediatric medicines is a global problem. Since paediatric patients are a high-risk group, a developer of paediatric medicines needs to evaluate and minimise unjustified risks early in the development process.The aim of the study
Externí odkaz:
https://doaj.org/article/3268eaa783104a988e528fef417bc508