Zobrazeno 1 - 4
of 4
pro vyhledávání: '"M. M. Marshalova"'
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 14, Iss 5, Pp 561-571 (2024)
INTRODUCTION. In 2023, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a new Guideline on Analytical Procedure Development (ICH Q14) and a revised version of the Guideline on Val
Externí odkaz:
https://doaj.org/article/b5afa292376e4b0997076f26dad2a5a2
Autor:
Zh. I. Aladysheva, N. V. Pyatigorskaya, V. V. Beregovykh, G. E. Brkich, A. P. Meshkovskiy, M. M. Marshalova, V. V. Belyaev, N. S. Nikolenko, E. I. Nesterkina, A. A. Kamaletdinova, M. F. Lutfullin
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 13, Iss 3, Pp 453-463 (2023)
Scientific relevance. In December 2020, the Russian Federation adopted the Eurasian Economic Union (EAEU) requirements. This has significantly changed the certification procedure for qualified persons (QPs) of manufacturers of medicinal products for
Externí odkaz:
https://doaj.org/article/a3e0132b54024531a876bad9a6c3ceed
Autor:
A. P. Meshkovskiy, N. V. Pyatigorskaya, Z. I. Aladysheva, V. V. Beregovykh, A. M. Pyatigorskiy, N. S. Nikolenko, M. M. Marshalova, V. V. Belyaev
Publikováno v:
Разработка и регистрация лекарственных средств, Vol 9, Iss 4, Pp 164-170 (2020)
Introduction. The article is focused on differences in quality assurance-related obligations and responsibilities between Marketing Authorisation Holders (MAHs) and manufacturing authorisation holder (manufacturers) in pharmaceutical industry. In cas
Externí odkaz:
https://doaj.org/article/2cfb3fb55f4c42ddabecd9cf63568154
Autor:
V. V. Beregovykh, A. P. Meshkovskiy, A. M. Pyatigorskiy, Z. I. Aladysheva, N. S. Nikolenko, N. V. Pyatigorskaya, V. V. Belyaev, M. M. Marshalova
Publikováno v:
Разработка и регистрация лекарственных средств, Vol 9, Iss 4, Pp 164-170 (2020)
Introduction. The article is focused on differences in quality assurance-related obligations and responsibilities between Marketing Authorisation Holders (MAHs) and manufacturing authorisation holder (manufacturers) in pharmaceutical industry. In cas
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3b2ba625f4ba3dccdbe4becb71632dce
https://www.pharmjournal.ru/jour/article/view/821
https://www.pharmjournal.ru/jour/article/view/821