Zobrazeno 1 - 10
of 29
pro vyhledávání: '"S M, Sukhanova"'
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 23, Iss 1, Pp 65-75 (2023)
Preventive vaccination against SARS-CoV-2 infection is currently receiving close attention in the Russian Federation. Improving public confidence in immunisation with new vaccines largely depends on a guarantee of the absence of side effects caused b
Externí odkaz:
https://doaj.org/article/2cb4c88ccf0c4ecea08bedcaa5b68360
Autor:
S. M. Sukhanova
Publikováno v:
Разработка и регистрация лекарственных средств, Vol 12, Iss 1, Pp 123-130 (2023)
Introduction. A reliable assessment of the quality and safety of medical products (MP) by biological indicators is directly related to the use of culture media (CM) that meet the established requirements. However, when conducting trial, it is necessa
Externí odkaz:
https://doaj.org/article/2aa288b052f94eecb21be05f0184719f
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 22, Iss 3, Pp 331-346 (2022)
The State Pharmacopoeia of the Russian Federation (Ph.Rus.) requires a preparatory evaluation of culture medium suitability using the reference standard (RS) of the Mycoplasma arginini G230 test strain in order to ensure reliable results when testing
Externí odkaz:
https://doaj.org/article/1be0c191a02544ee9a5541b4462649f4
Publikováno v:
Проблемы особо опасных инфекций, Vol 0, Iss 3, Pp 87-93 (2019)
Objective of the study - analysis of standard indicators and methods, utilized for determination of presence of contaminating microorganisms in live bacterial vaccines. Materials and methods. We used the data from the State Pharmacopeia of the USSR,
Externí odkaz:
https://doaj.org/article/a3436004901549b683dbd20cfd7efb7d
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 19, Iss 3, Pp 185-192 (2019)
In accordance with the requirements of the State Pharmacopoeia of the Russian Federation, 14th edition, Clostridium novyi 198 test strain is used to determine growth promoting properties of thioglycollate medium when testing sterility of immunobiolog
Externí odkaz:
https://doaj.org/article/40714db028c74ae089801b1cf7ae837f
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 19, Iss 3, Pp 161-168 (2019)
An urgent safety concern associated with biological products is contamination with mycoplasmas, which may originate from donor tissues and organs, virus harvests, culture medium components, trypsin, animal blood serum, as well as be transmitted by pe
Externí odkaz:
https://doaj.org/article/2fa80b379c414178802c648e5f7f4bf9
Autor:
S. M. Sukhanova, N. E. Zakharova
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 19, Iss 3, Pp 136-144 (2019)
Culture media with predetermined specific characteristics play a key role in ensuring safety, quality and efficacy of medicinal products, especially biologicals. It is necessary to formulate clear criteria for culture media suitability, because they
Externí odkaz:
https://doaj.org/article/e5a63a89a4274389ab4f61a0e4cbc1e0
Autor:
S. M. Sukhanova, N. M. Minaeva
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 19, Iss 2, Pp 99-108 (2019)
Parenteral dosage forms are dissolved using sterile water for injection whose quality is regulated by special requirements. The lack of a monograph on sterile water for injection in the State Pharmacopoeia of the Russian Federation, as well as the co
Externí odkaz:
https://doaj.org/article/3125656f693b414ca223d903c1fa2bd6
Autor:
S. M. Sukhanova, N. E. Zakharova
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 18, Iss 3, Pp 191-197 (2018)
Medicinal products fail sterility testing if visual observation shows the growth of microorganisms that manifests itself as turbidity, sedimentation, flocculation and other changes in the growth medium. A key factor allowing robust determination of c
Externí odkaz:
https://doaj.org/article/b66fc283279a45d59ffca9fe984f0045
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 18, Iss 2, Pp 106-113 (2018)
The production of biological medicinal products used for prophylactic, diagnostic and therapeutic purposes includes the use of inherently variable biological processes and materials. In order to ensure the quality of the finished biological product i
Externí odkaz:
https://doaj.org/article/5bca7b345e324d168d21ee8b70ad95b9