Výsledky vyhledávání - "Margarita A. Dranitsyna"

Autor: Ravil R. Niyazov, Elena V. Gavrishina, Margarita A. Dranitsyna, Andrey N. Vasiliev

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

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Unapproved clinical trials in Russia: exception or norm?

Autor: Margarita A. Dranitsyna, Petr Talantov, Ravil R. Niyazov, Ilya Yasny, Galina M. Viryasova

Publikováno v: BMC Medical Ethics, Vol 22, Iss 1, Pp 1-8 (2021)
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

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