Results 1 to 10 of about 415 (104)
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
doaj +2 more sources
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
doaj +2 more sources
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
doaj +1 more source
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
doaj +2 more sources
Регуляторные исследования и экспертиза лекарственных средств, 2018 Analysis of XI and XII editions of the State Pharmacopoeia of the Russian Federation proved the necessity and relevance of elaborating quality standards for immunobiological medicinal products as well as methods of their control.
A. A. Movsesyants +4 more
doaj +1 more source
State Pharmacopoeia of the Russian Federation in modern pharmaceutical analysis practice
Регуляторные исследования и экспертиза лекарственных средств, 2018 The Russian State Pharmacopoeia XIII edition assures the quality of medicines, it is important for all the stakeholders in the sphere of the circulation of medicines, ranging from pharmaceutical development to distribution of medicinal products, both for
I. A. Narkevich
doaj +1 more source
A Risk-Based Approach to Planning the Elaboration of Pharmacopoeial Monographs
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
doaj +1 more source
NMR as Used in the Russian and Foreign Pharmacopoeias for Quality Control of Medicinal Products
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
doaj +1 more source
Comparison of the World Pharmacopoeias’ Requirements for the Quality of Cell Lines
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
doaj +1 more source
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
doaj +1 more source