Minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the State Pharmacopoeia of the Russian Federation [PDF]
Биопрепараты: Профилактика, диагностика, лечение, 2022 To ensure the safety and to secure the approval of injectable medicinal products based on antigen-specific immunoglobulins of animal origin, it is necessary to exclude their contamination with adventitious human pathogens.
V. V. Mashin +6 more
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Outdated latin names of medicinal plants in the monographs of the State Pharmacopoeia of the Russian Federation, XIV edition (review) [PDF]
Разработка и регистрация лекарственных средствIntroduction. The State Pharmacopoeia of the Russian Federation, XIV-th edition (SP XIV), includes 107 monographs devoted to medicinal plant materials. The purpose of the study was to identify incorrect Latin names of medicinal plants in the monographs ...
M. N. Povydysh, M. Yu. Goncharov
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A Risk-Based Approach to Planning the Elaboration of Pharmacopoeial Monographs [PDF]
Регуляторные исследования и экспертиза лекарственных средств, 2023 Scientific relevance. This article describes a risk-based analysis of the need for elaborating pharmacopoeial requirements for 6 therapeutic groups of medicines, including an evaluation of the range and number of batches of these medicines put into the ...
A. V. Yarutkin, V. L. Bagirova
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NMR as Used in the Russian and Foreign Pharmacopoeias for Quality Control of Medicinal Products [PDF]
Регуляторные исследования и экспертиза лекарственных средств, 2022 The ongoing development of the Pharmacopoeia of the Eurasian Economic Union and the current trend for harmonisation of the Russian Pharmacopoeia with the world leading pharmacopoeias suggest the necessity of studying how different pharmacopoeias use ...
S. V. Moiseev +2 more
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State Pharmacopoeia of the Russian Federation Edition XV: Development Priorities
Регуляторные исследования и экспертиза лекарственных средствINTRODUCTION. Regular reviews of the current portfolio of general chapters and monographs are essential to ensure the well-balanced development of the State Pharmacopoeia of the Russian Federation (Ph.
A. V. Yarutkin, V. L. Bagirova
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Recommendations on Describing the Requirements for Microbiological Quality and Sterility of Medicinal Products [PDF]
Регуляторные исследования и экспертиза лекарственных средств, 2022 The paper presents recommendations on describing analytical procedures for evaluation of medicinal products in terms of sterility and microbiological quality in accordance with the State Pharmacopoeia of the Russian Federation and the Pharmacopoeia of ...
O. V. Gunar
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Comparison of the World Pharmacopoeias’ Requirements for the Quality of Cell Lines [PDF]
Биопрепараты: Профилактика, диагностика, лечение, 2020 The cell line is one of the necessary components of a biomedical cell product (BMCP) which can include only viable human cells. In addition, human, animal, insect, or bacterial cell lines can be used as a substrate for the production of some biological ...
M. A. Vodyakova +3 more
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Control of Organic Impurities in Semisynthetic Antibiotics [PDF]
Регуляторные исследования и экспертиза лекарственных средств, 2022 In 2012, the European Medicines Agency (EMA) adopted a guideline, which divided all antibiotics into groups according to the manufacturing process and established acceptance criteria for organic impurities for each of the groups.The aim of the study was ...
E. L. Kovaleva +4 more
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Practical Aspects of Processing and Interpretation of the Results of Microbiological Analysis of the Quality of Non-Sterile Medicines [PDF]
Регуляторные исследования и экспертиза лекарственных средств, 2022 The article presents materials on processing and interpretation of the results of microbiological analysis of the quality of medicines in accordance with the State Pharmacopoeia of the Russian Federation and the Pharmacopoeia of the Eurasian Economic ...
O. V. Gunar
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Регуляторные исследования и экспертиза лекарственных средств, 2018 The State Pharmacopoeia of the Russian Federation is a collection of general monographs and pharmacopoeial monographs. It should be reissued at least once in 5 years.
V. A. Merkulov +4 more
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