Zobrazeno 1 - 10
of 36
pro vyhledávání: '"O. V. Fadeikina"'
Autor:
L. A. Gaiderova, Yu. N. Lebedeva, T. N. Lobanova, E. K. Lipatova, R. A. Volkova, O. V. Fadeikina
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 24, Iss 1, Pp 21-31 (2024)
SCIENTIFIC RELEVANCE. Potency testing of recombinant interferons requires a reference standard. The availability of International Standards (ISs) that are commonly used to assess the quality of recombinant interferons is currently limited. Therefore,
Externí odkaz:
https://doaj.org/article/7f5cd8ab5a9b417ea6f74e8f58dd1222
Autor:
R. A. Volkova, O. V. Fadeikina, O. B. Ustinnikova, K. A. Sarkisyan, A. A. Movsesyants, V. A. Merkulov, V. V. Kosenko
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 24, Iss 1, Pp 7-20 (2024)
SCIENTIFIC RELEVANCE. The use of appropriately certified reference standards (RSs) is a necessary element of analytical procedure standardisation that ensures comparability of results across different laboratories assessing the quality of medicines,
Externí odkaz:
https://doaj.org/article/5144791c99b742c4bb2c374d35148a77
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 23, Iss 4, Pp 584-593 (2023)
Scientific relevance. Viable cell counting is an important microbiological test for the quality assessment of medicinal products containing live microorganisms. To optimise labour and material costs and enhance testing precision and reproducibility,
Externí odkaz:
https://doaj.org/article/6956fb106a0a44f7ac55b246eced230a
Autor:
A. V. Nechaev, E. Yu. Kudasheva, E. L. Postnova, R. A. Volkova, O. V. Fadeikina, I. V. Borisevich, A. A. Movsesyants
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 23, Iss 3-1, Pp 443-451 (2023)
Scientific relevance. The immunoglobulin A (IgA) impurity content in parenteral human immunoglobulins should be determined in accordance with the State Pharmacopoeia of the Russian Federation by kinetic nephelometry, radial immunodiffusion, or enzyme
Externí odkaz:
https://doaj.org/article/a2bc34d96ed248e7b7e62345dad71964
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 23, Iss 3-1, Pp 452-462 (2023)
Scientific relevance. GOST ISO/IEC 17025-2019 requires testing laboratories to evaluate the measurement uncertainty of their results. Estimating the uncertainty of analytical methods intended for biologicals is a challenging task that requires time,
Externí odkaz:
https://doaj.org/article/e81470a0a0374fca9ab6adaf54d157a7
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 23, Iss 3, Pp 348-360 (2023)
Scientific relevance. Lyophilisation is the preferred method at the National Collection of Pathogenic Microorganisms (NCPM) of the Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation. Lyop
Externí odkaz:
https://doaj.org/article/d5de17a3de424a57bf9371798c042554
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:
Биопрепараты: Профилактика, диагностика, лечение, Vol 22, Iss 2, Pp 208-217 (2022)
One of the factors influencing the uncertainty of residual moisture measurements in biological medicinal products is the accumulation of electrostatic charge on the surfaces of weighing bottles and laboratory balances, which results in poor weighing
Externí odkaz:
https://doaj.org/article/d946a03ade0e4a5e97aaed10a98d68ac
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 22, Iss 1, Pp 49-59 (2022)
Assessment of prekallikrein content is essential for safety control of human immunoglobulin and albumin products. The inherent variability of human prekallikrein reagents and chromogenic substrates indicates the need for standardisation of the chromo
Externí odkaz:
https://doaj.org/article/37fe758fc7e4446e887bcdb59c0eb4c7
Publikováno v:
Биопрепараты: Профилактика, диагностика, лечение, Vol 22, Iss 1, Pp 94-104 (2022)
The light obscuration method described in the State Pharmacopoeia of the Russian Federation for subvisible particle testing, provides for preparation of a pooled sample with a minimum volume of 25 mL to be used in four measurements, each with 5.0 mL
Externí odkaz:
https://doaj.org/article/4f74517ef5434163bf2e271523cd8479