Results 31 to 40 of about 1,535 (117)

Modern approaches to drafting general and individual monographs on human blood products

Регуляторные исследования и экспертиза лекарственных средств, 2018
Blood products were first represented in the State Pharmacopoeia of the USSR IX and X editions (1961 and 1968) by a single monograph "Gamma globulin for the prevention of measles".
A. V. Karyakin, T. M. Kargina, E. I. Sakanyan, I. G. Osipova, A. A. Movsesyants, E. Y. Kudasheva   +5 more
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New opportunities for the determination of active substances in organic compounds

Регуляторные исследования и экспертиза лекарственных средств, 2018
The general monograph developed for the Russian State Pharmacopoeia describes the opportunity for using special equipment called «elemental analyzer» to solve the problem of determining active ingredients in pharmaceuticals by determining the elements C,
L. I. Mitkina
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Evaluation of the Stability of Performance of the Analytical Test Method Used for Determination of Anticomplementary Activity of Human Immunoglobulin Preparations

Биопрепараты: Профилактика, диагностика, лечение, 2019
The evaluation of anticomplementary activity, being an obligatory component of the quality control ofhuman immunoglobulin preparations, requires the use of a number of reagents of biological origin that are difficult to standardise.
O. G. Kornilova, E. A. Khusnatdinova, E. S. Konovalova, R. A. Volkova   +3 more
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Elemental Impurities in Gelatine Capsules: Human Health Risk Assessment

Безопасность и риск фармакотерапии
INTRODUCTION. This work continues the authors’ earlier study on gelatine capsule contamination with elemental impurities, which resulted in proposing a list of elements for standardisation. To ensure the safe use of medicinal products in this dosage form,
V. M. Schukin, N. E. Kuz'mina, O. A. Matveeva, Yu. N. Shvetsova, E. S. Zhigilei   +4 more
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Elaboration of Pharmacopoeial Quality Standards for Bacteriophage Products

Биопрепараты: Профилактика, диагностика, лечение, 2019
Bacteriophages are novel safe and efficacious medicinal products that are used for treatment of intestinal infections and purulent inflammations. The fact that virulent phages can be adapted to fight antibiotic-resistant bacterial strains makes this ...
T. M. Kargina, E. I. Sakanyan, D. S. Davydov, R. L. Parfenyuk   +3 more
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ASPECTS OF MEDICINES QUALITY EVALUATION BY ELECTRICAL SENSING ZONE METHOD

Регуляторные исследования и экспертиза лекарственных средств, 2018
The article describes standard methodological approaches to the determination of subvisible particles by electrical sensing zone method (the Coulter principle).
E. S. Novik, A. V. Dorenskaya, N. A. Borisova, O. V. Gunar   +3 more
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The State Pharmacopoeia - main standard of quality of medicines and medical devices in the Republic of Kazakhstan

Регуляторные исследования и экспертиза лекарственных средств, 2018
Since the publication of the first edition of the Republic’s of Kazakhstan State Pharmacopoeia (RKSP) there have been significant changes in the requirements for the pharmacopoeia, and in the understanding of its role as the main standard of quality for ...
S. R. Musinov, A. U. Tulegenova
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Harmonising Compendial Requirements for Vegetable Fatty Oils

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. Vegetable fatty oils are widely used in modern pharmaceutical practice. Depending on production and purification method, they can serve as an active pharmaceutical substance and/or as an excipient.
O. V. Evdokimova, I. V. Klinkova
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Harmonization and updating as basic principles of the development of the Republic of Kazakhstan state pharmacopoeia

Регуляторные исследования и экспертиза лекарственных средств, 2018
The second edition of the Republic of Kazakhstan State Pharmacopoeia (RKSP 2.0) is the practical implementation of the principles of continuous development, harmonization and updating. Features of RKSP harmonization with the leading pharmacopoeias of the
S. R. Musinov, A. U. Tulegenova
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Shared knowledge centre (research and education centre) of the Peoples’ Friendship University of Russia as a modern experimental basis for the development of drug standards

Регуляторные исследования и экспертиза лекарственных средств, 2018
Shared Knowledge Centre (Research and Education Centre) of the Peoples’ Friendship University of Russia (SKC (REC) PFUR) was established in 2009. It is equipped with modern advanced measuring and testing equipment.
R. A. Abramovich, O. G. Potanina, V. V. Chistyakov, S. V. Goryainov, A. N. Vorobiev, A. V. Nikulin   +5 more
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