19 research outputs found
Realizations of Real Low-Dimensional Lie Algebras
Using a new powerful technique based on the notion of megaideal, we construct
a complete set of inequivalent realizations of real Lie algebras of dimension
no greater than four in vector fields on a space of an arbitrary (finite)
number of variables. Our classification amends and essentially generalizes
earlier works on the subject.
Known results on classification of low-dimensional real Lie algebras, their
automorphisms, differentiations, ideals, subalgebras and realizations are
reviewed.Comment: LaTeX2e, 39 pages. Essentially exetended version. Misprints in
Appendix are correcte
Current approaches to quality assessment, non-clinical and clinical studies of dendritic cell vaccines in oncology
At present, personalised cellular immunotherapy is considered a promising approach to the treatment of malignant neoplasms. The effectiveness of these cellular immunotherapy methods is evaluated in the context of clinical and biological tumour characteristics and the state of the immune system of a particular patient. One of the immunotherapy options for cancer is the development of autologous dendritic cell vaccines.The aim of this study was to analyse current methodological approaches to the evaluation of the quality, efficacy, and safety of dendritic cell cancer vaccines.This review describes the functional role of dendritic cells in immune response regulation. The paper presents the results of literature analysis covering current approaches to obtaining dendritic cell vaccines with specific characteristics, quality assessment, studies of the anti-tumour efficacy of cell therapy products, and the experience of conducting non-clinical and clinical studies. The review highlights specific aspects of international experience in the registration and clinical use of cell therapy products. The authors discuss methodological approaches to non-clinical studies of dendritic cell vaccines, which should aim to obtain information to select the dose, route, and mode of administration and to identify immunological markers correlating to the clinical efficacy of cell therapy products. The paper covers international experience in conducting clinical trials of dendritic cell vaccines for various malignant neoplasms. The authors propose a list of quality attributes of human somatic cell-based medicinal products for further clinical use
ΠΠΠ‘ΠΠΠΠΠΠΠΠΠ― ΠΠΠ§ΠΠ« ΠΠ Π―ΠΠ¦Π ΠΠΠΠ¬ΠΠΠΠ’ΠΠ
The method of research of tests of the soil on eggs of helminths which sur- passes the method of Romanenko offered earlier in the efficiency is offered and can be used in practice and when carrying out scientific researches. This method was applied to inspection of objects of environment of Kazan city and allowed to reveal big impurity eggs of geohelminths. The developed method allowed to reveal in addition about 36 % of eggs of ascarids than on Romanenko's method that is caused by application of several components in flotation liquid: solutions of chlo- ride of zinc and sodium chloride and glycerin. Components of the flotation liquid don't break morphology of eggs of parasites and don't create difficulties with mor- phological identification of the helminthsΠΡΠ΅Π΄Π»ΠΎΠΆΠ΅Π½ ΠΌΠ΅ΡΠΎΠ΄ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΡ ΠΏΡΠΎΠ± ΠΏΠΎΡΠ²Ρ Π½Π° ΡΠΉΡΠ° Π³Π΅Π»ΡΠΌΠΈΠ½ΡΠΎΠ², ΠΊΠΎΡΠΎΡΡΠΉ ΠΏΡΠ΅Π²ΠΎΡΡ
ΠΎΠ΄ΠΈΡ ΠΏΠΎ ΡΠ²ΠΎΠ΅ΠΉ ΡΡ- ΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΏΡΠ΅Π΄Π»ΠΎΠΆΠ΅Π½Π½ΡΠΉ ΡΠ°Π½Π΅Π΅ ΠΌΠ΅ΡΠΎΠ΄ Π ΠΎΠΌΠ°Π½Π΅Π½ΠΊΠΎ ΠΈ ΠΌΠΎΠΆΠ΅Ρ Π±ΡΡΡ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ Π½Π° ΠΏΡΠ°ΠΊΡΠΈΠΊΠ΅ ΠΈ ΠΏΡΠΈ ΠΏΡΠΎΠ²Π΅Π΄Π΅- Π½ΠΈΠΈ Π½Π°ΡΡΠ½ΡΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ. ΠΠ°Π½Π½ΡΠΉ ΠΌΠ΅ΡΠΎΠ΄ Π±ΡΠ» ΠΏΡΠΈ- ΠΌΠ΅Π½Π΅Π½ Π΄Π»Ρ ΠΎΠ±ΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΡ ΠΎΠ±ΡΠ΅ΠΊΡΠΎΠ² Π²Π½Π΅ΡΠ½Π΅ΠΉ ΡΡΠ΅Π΄Ρ Π³ΠΎ- ΡΠΎΠ΄Π° ΠΠ°Π·Π°Π½ΠΈ ΠΈ ΠΏΠΎΠ·Π²ΠΎΠ»ΠΈΠ» Π²ΡΡΠ²ΠΈΡΡ Π±ΠΎΠ»ΡΡΡΡ Π·Π°Π³ΡΡΠ·Π½Π΅Π½- Π½ΠΎΡΡΡ ΡΠΉΡΠ°ΠΌΠΈ Π³Π΅ΠΎΠ³Π΅Π»ΡΠΌΠΈΠ½ΡΠΎΠ². Π Π°Π·ΡΠ°Π±ΠΎΡΠ°Π½Π½ΡΠΉ ΠΌΠ΅ΡΠΎΠ΄ ΠΏΠΎΠ·Π²ΠΎΠ»ΠΈΠ» Π΄ΠΎΠΏΠΎΠ»Π½ΠΈΡΠ΅Π»ΡΠ½ΠΎ Π²ΡΡΠ²ΠΈΡΡ ΠΏΡΠΈΠ±Π»ΠΈΠ·ΠΈΡΠ΅Π»ΡΠ½ΠΎ 36 % ΡΠΈΡ Π°ΡΠΊΠ°ΡΠΈΠ΄, ΡΠ΅ΠΌ ΠΏΠΎ ΠΌΠ΅ΡΠΎΠ΄Ρ Π ΠΎΠΌΠ°Π½Π΅Π½ΠΊΠΎ, ΡΡΠΎ ΠΎΠ±Ρ- ΡΠ»ΠΎΠ²Π»Π΅Π½ΠΎ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΠ΅ΠΌ Π½Π΅ΡΠΊΠΎΠ»ΡΠΊΠΈΡ
ΠΊΠΎΠΌΠΏΠΎΠ½Π΅Π½ΡΠΎΠ² Π² ΡΠ»ΠΎΡΠ°ΡΠΈΠΎΠ½Π½ΠΎΠΉ ΠΆΠΈΠ΄ΠΊΠΎΡΡΠΈ: ΡΠ°ΡΡΠ²ΠΎΡΠΎΠ² Ρ
Π»ΠΎΡΠΈΠ΄Π° ΡΠΈΠ½ΠΊΠ°, Ρ
Π»ΠΎΡΠΈΠ΄Π° Π½Π°ΡΡΠΈΡ ΠΈ Π³Π»ΠΈΡΠ΅ΡΠΈΠ½Π°. ΠΠΎΠΌΠΏΠΎΠ½Π΅Π½ΡΡ ΠΏΡΠ΅Π΄Π»Π°Π³Π°Π΅- ΠΌΠΎΠΉ ΡΠ»ΠΎΡΠ°ΡΠΈΠΎΠ½Π½ΠΎΠΉ ΡΠΈΡΡΠ΅ΠΌΡ Π½Π΅ Π½Π°ΡΡΡΠ°ΡΡ ΠΌΠΎΡΡΠΎΠ»ΠΎΠ³ΠΈΡ ΡΠΈΡ ΠΏΠ°ΡΠ°Π·ΠΈΡΠΎΠ² ΠΈ Π½Π΅ ΡΠΎΠ·Π΄Π°ΡΡ Π·Π°ΡΡΡΠ΄Π½Π΅Π½ΠΈΠΉ Ρ ΠΌΠΎΡΡΠΎΠ»ΠΎΠ³ΠΈ- ΡΠ΅ΡΠΊΠΎΠΉ ΠΈΠ΄Π΅Π½ΡΠΈΡΠΈΠΊΠ°ΡΠΈΠ΅ΠΉ Π²ΠΎΠ·Π±ΡΠ΄ΠΈΡΠ΅Π»
Block Copolymers of Ethylene Oxide andΒ Propylene Oxide: Prospects for Medical and Pharmaceutical Application in Russia
Block copolymers of ethylene oxide and propylene oxide (EO/PO block copolymers) are polymeric non-ionic surfactants with a high hydrophilicβlipophilic balance also referred to as pluronics, poloxamers, or proxanols. These compounds are among the most demanded modern excipients for the production of medicines. EO/PO block copolymers are used both in the production of traditional (liquid, semi-solid, and solid) dosage forms and as part of targeted delivery systems. The extensive application of EO/PO block copolymers is due to the diverse array of their properties, including not only solubilising, emulsifying, gelling, and other effects but also thermoreversibility, which is essential for developing in situ delivery systems and 3D printing technologies.The aim of the study was to evaluate the potential of EO/PO block copolymers for medicinal use and to assess the range of medicinal products approved in the Russian Federation that contain EO/PO block copolymers.This review presents an analysis of the register of poloxamer-containing medicines approved in the Russian Federation, a list of the largest manufacturers of EO/PO block copolymers in the world, and a study of the possibility to use copolymers for medical purposes. Currently, there are more than 10 chemical manufacturers producing EO/PO block copolymers for the pharmaceutical, biotechnology, and other industries around the world. EO/PO block copolymers are included in more than 60 medicinal products present in the Russian pharmaceutical market; this observation indicates the need to phase out the import of poloxamers
CΠΎΠ²ΡΠ΅ΠΌΠ΅Π½Π½ΡΠ΅ ΠΏΠΎΠ΄Ρ ΠΎΠ΄Ρ ΠΊ ΠΎΡΠ΅Π½ΠΊΠ΅ ΠΊΠ°ΡΠ΅ΡΡΠ²Π°, ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ Π΄ΠΎΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ ΠΈ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ Π΄Π΅Π½Π΄ΡΠΈΡΠ½ΠΎ-ΠΊΠ»Π΅ΡΠΎΡΠ½ΡΡ Π²Π°ΠΊΡΠΈΠ½ Π² ΠΎΠ½ΠΊΠΎΠ»ΠΎΠ³ΠΈΠΈ
At present, personalised cellular immunotherapy is considered a promising approach to the treatment of malignant neoplasms. The effectiveness of these cellular immunotherapy methods is evaluated in the context of clinical and biological tumour characteristics and the state of the immune system of a particular patient. One of the immunotherapy options for cancer is the development of autologous dendritic cell vaccines.The aim of this study was to analyse current methodological approaches to the evaluation of the quality, efficacy, and safety of dendritic cell cancer vaccines.This review describes the functional role of dendritic cells in immune response regulation. The paper presents the results of literature analysis covering current approaches to obtaining dendritic cell vaccines with specific characteristics, quality assessment, studies of the anti-tumour efficacy of cell therapy products, and the experience of conducting non-clinical and clinical studies. The review highlights specific aspects of international experience in the registration and clinical use of cell therapy products. The authors discuss methodological approaches to non-clinical studies of dendritic cell vaccines, which should aim to obtain information to select the dose, route, and mode of administration and to identify immunological markers correlating to the clinical efficacy of cell therapy products. The paper covers international experience in conducting clinical trials of dendritic cell vaccines for various malignant neoplasms. The authors propose a list of quality attributes of human somatic cell-based medicinal products for further clinical use.ΠΠ° ΡΠ΅Π³ΠΎΠ΄Π½ΡΡΠ½ΠΈΠΉ Π΄Π΅Π½Ρ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΠ΅ ΠΏΠ΅ΡΡΠΎΠ½Π°Π»ΠΈΠ·ΠΈΡΠΎΠ²Π°Π½Π½ΡΡ
ΠΌΠ΅ΡΠΎΠ΄ΠΎΠ² ΠΊΠ»Π΅ΡΠΎΡΠ½ΠΎΠΉ ΠΈΠΌΠΌΡΠ½ΠΎΡΠ΅ΡΠ°ΠΏΠΈΠΈ Π·Π»ΠΎΠΊΠ°ΡΠ΅ΡΡΠ²Π΅Π½Π½ΡΡ
Π½ΠΎΠ²ΠΎΠΎΠ±ΡΠ°Π·ΠΎΠ²Π°Π½ΠΈΠΉ ΡΠ°ΡΡΠΌΠ°ΡΡΠΈΠ²Π°Π΅ΡΡΡ ΠΊΠ°ΠΊ ΠΏΠ΅ΡΡΠΏΠ΅ΠΊΡΠΈΠ²Π½ΡΠΉ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄ ΠΊ Π»Π΅ΡΠ΅Π½ΠΈΡ ΠΎΠΏΡΡ
ΠΎΠ»Π΅ΠΉ, Π° ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ ΡΡΠΈΡ
ΠΌΠ΅ΡΠΎΠ΄ΠΎΠ² ΠΎΡΠ΅Π½ΠΈΠ²Π°Π΅ΡΡΡ Π² ΠΊΠΎΠ½ΡΠ΅ΠΊΡΡΠ΅ ΠΊΠ»ΠΈΠ½ΠΈΠΊΠΎ-Π±ΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΡ
Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊ ΠΎΠΏΡΡ
ΠΎΠ»ΠΈ ΠΈ ΡΠΎΡΡΠΎΡΠ½ΠΈΡ ΠΈΠΌΠΌΡΠ½Π½ΠΎΠΉ ΡΠΈΡΡΠ΅ΠΌΡ ΠΊΠΎΠ½ΠΊΡΠ΅ΡΠ½ΠΎΠ³ΠΎ ΠΏΠ°ΡΠΈΠ΅Π½ΡΠ°. ΠΠ΄Π½ΠΈΠΌ ΠΈΠ· Π²Π°ΡΠΈΠ°Π½ΡΠΎΠ² ΠΈΠΌΠΌΡΠ½ΠΎΡΠ΅ΡΠ°ΠΏΠΈΠΈ ΡΠ²Π»ΡΠ΅ΡΡΡ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠΊΠ° Π°ΡΡΠΎΠ»ΠΎΠ³ΠΈΡΠ½ΡΡ
ΠΏΡΠΎΡΠΈΠ²ΠΎΠΎΠΏΡΡ
ΠΎΠ»Π΅Π²ΡΡ
Π²Π°ΠΊΡΠΈΠ½ Π½Π° ΠΎΡΠ½ΠΎΠ²Π΅ Π΄Π΅Π½Π΄ΡΠΈΡΠ½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊ.Π¦Π΅Π»Ρ ΡΠ°Π±ΠΎΡΡ β Π°Π½Π°Π»ΠΈΠ· ΡΠΎΠ²ΡΠ΅ΠΌΠ΅Π½Π½ΡΡ
ΠΌΠ΅ΡΠΎΠ΄ΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΏΠΎΠ΄Ρ
ΠΎΠ΄ΠΎΠ² ΠΊ ΠΎΡΠ΅Π½ΠΊΠ΅ ΠΊΠ°ΡΠ΅ΡΡΠ²Π°, ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΈ Π±Π΅Π·ΠΎΠΏΠ°ΡΠ½ΠΎΡΡΠΈ ΠΏΡΠΎΡΠΈΠ²ΠΎΠΎΠΏΡΡ
ΠΎΠ»Π΅Π²ΡΡ
Π²Π°ΠΊΡΠΈΠ½ Π½Π° ΠΎΡΠ½ΠΎΠ²Π΅ Π΄Π΅Π½Π΄ΡΠΈΡΠ½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊ.Π ΠΎΠ±Π·ΠΎΡΠ΅ ΠΏΡΠΈΠ²Π΅Π΄Π΅Π½ΠΎ ΠΎΠΏΠΈΡΠ°Π½ΠΈΠ΅ ΡΡΠ½ΠΊΡΠΈΠΎΠ½Π°Π»ΡΠ½ΠΎΠΉ ΡΠΎΠ»ΠΈ Π΄Π΅Π½Π΄ΡΠΈΡΠ½ΡΡ
ΠΊΠ»Π΅ΡΠΎΠΊ Π² ΡΠ΅Π³ΡΠ»ΡΡΠΈΠΈ ΠΈΠΌΠΌΡΠ½Π½ΠΎΠ³ΠΎ ΠΎΡΠ²Π΅ΡΠ°, Π° ΡΠ°ΠΊΠΆΠ΅ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ Π°Π½Π°Π»ΠΈΠ· Π΄Π°Π½Π½ΡΡ
Π»ΠΈΡΠ΅ΡΠ°ΡΡΡΡ, ΠΏΠΎΡΠ²ΡΡΠ΅Π½Π½ΡΡ
ΡΠΎΠ²ΡΠ΅ΠΌΠ΅Π½Π½ΡΠΌ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄Π°ΠΌ ΠΏΠΎΠ»ΡΡΠ΅Π½ΠΈΡ Π΄Π΅Π½Π΄ΡΠΈΡΠ½ΠΎ-ΠΊΠ»Π΅ΡΠΎΡΠ½ΡΡ
Π²Π°ΠΊΡΠΈΠ½ Ρ Π·Π°Π΄Π°Π½Π½ΡΠΌΠΈ Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊΠ°ΠΌΠΈ, ΠΎΡΠ΅Π½ΠΊΠ΅ ΠΊΠ°ΡΠ΅ΡΡΠ²Π°, ΠΈΠ·ΡΡΠ΅Π½ΠΈΡ ΠΏΡΠΎΡΠΈΠ²ΠΎΠΎΠΏΡΡ
ΠΎΠ»Π΅Π²ΠΎΠΉ ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΊΠ»Π΅ΡΠΎΡΠ½ΠΎΠ³ΠΎ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°, Π° ΡΠ°ΠΊΠΆΠ΅ ΠΎΠΏΡΡΡ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ Π΄ΠΎΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ. ΠΡΠ²Π΅ΡΠ΅Π½Ρ ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠΈΠ΅ Π°ΡΠΏΠ΅ΠΊΡΡ ΠΌΠ΅ΠΆΠ΄ΡΠ½Π°ΡΠΎΠ΄Π½ΠΎΠ³ΠΎ ΠΎΠΏΡΡΠ° ΡΠ΅Π³ΠΈΡΡΡΠ°ΡΠΈΠΈ ΠΈ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΊΠ»Π΅ΡΠΎΡΠ½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ². Π ΠΎΠ±Π·ΠΎΡΠ΅ ΠΎΠ±ΡΡΠΆΠ΄Π΅Π½Ρ ΠΌΠ΅ΡΠΎΠ΄ΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΠ΅ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄Ρ ΠΊ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ Π΄ΠΎΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ Π΄Π΅Π½Π΄ΡΠΈΡΠ½ΠΎ-ΠΊΠ»Π΅ΡΠΎΡΠ½ΡΡ
Π²Π°ΠΊΡΠΈΠ½, ΠΊΠΎΡΠΎΡΡΠ΅ Π΄ΠΎΠ»ΠΆΠ½Ρ Π±ΡΡΡ Π½Π°ΡΠ΅Π»Π΅Π½Ρ Π½Π° ΠΏΠΎΠ»ΡΡΠ΅Π½ΠΈΠ΅ ΡΠ²Π΅Π΄Π΅Π½ΠΈΠΉ Π΄Π»Ρ Π²ΡΠ±ΠΎΡΠ° Π΄ΠΎΠ·Ρ, ΠΎΠ±ΠΎΡΠ½ΠΎΠ²Π°Π½ΠΈΡ ΠΏΡΡΠΈ Π²Π²Π΅Π΄Π΅Π½ΠΈΡ, ΡΠ΅ΠΆΠΈΠΌΠ° ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΊΠ»Π΅ΡΠΎΡΠ½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ², Π° ΡΠ°ΠΊΠΆΠ΅ ΠΈΠ΄Π΅Π½ΡΠΈΡΠΈΠΊΠ°ΡΠΈΠΈ ΠΈΠΌΠΌΡΠ½ΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΌΠ°ΡΠΊΠ΅ΡΠΎΠ², ΠΊΠΎΡΡΠ΅Π»ΠΈΡΡΡΡΠΈΡ
Ρ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΎΠΉ ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΡ. Π Π°ΡΡΠΌΠΎΡΡΠ΅Π½ ΠΌΠ΅ΠΆΠ΄ΡΠ½Π°ΡΠΎΠ΄Π½ΡΠΉ ΠΎΠΏΡΡ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ Π΄Π΅Π½Π΄ΡΠΈΡΠ½ΠΎ-ΠΊΠ»Π΅ΡΠΎΡΠ½ΡΡ
Π²Π°ΠΊΡΠΈΠ½ ΠΏΡΠΈ ΡΠ°Π·Π»ΠΈΡΠ½ΡΡ
Π·Π»ΠΎΠΊΠ°ΡΠ΅ΡΡΠ²Π΅Π½Π½ΡΡ
Π½ΠΎΠ²ΠΎΠΎΠ±ΡΠ°Π·ΠΎΠ²Π°Π½ΠΈΡΡ
. ΠΡΠ΅Π΄Π»ΠΎΠΆΠ΅Π½ ΠΏΠ΅ΡΠ΅ΡΠ΅Π½Ρ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Π΅ΠΉ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° ΠΊΠ»Π΅ΡΠΎΡΠ½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² Π½Π° ΠΎΡΠ½ΠΎΠ²Π΅ ΡΠΎΠΌΠ°ΡΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΊΠ»Π΅ΡΠΎΠΊ ΡΠ΅Π»ΠΎΠ²Π΅ΠΊΠ° Π΄Π»Ρ ΠΈΡ
Π΄Π°Π»ΡΠ½Π΅ΠΉΡΠ΅Π³ΠΎ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΡ Π² ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΎΠΉ ΠΏΡΠ°ΠΊΡΠΈΠΊΠ΅
Review of the Certification Procedure for Qualified Persons of Manufacturers of Medicines for Human Use in Russia
Scientific relevance. In December 2020, the Russian Federation adopted the Eurasian Economic Union (EAEU) requirements. This has significantly changed the certification procedure for qualified persons (QPs) of manufacturers of medicinal products for human use in the Russian Federation. To accommodate these changes, the Russian regulatory framework needs further improvement.Aim. This study aimed to review the changes made to the mechanism of state regulation of medicines and to evaluate the impact on the pharmaceutical industry two years after the adoption of the current QP certification procedure.Discussion. This review compares two QP certification procedures established by Order No. 7n of the Ministry of Health of the Russian Federation dated 12 January 2021. The first is an abbreviated one for QPs certified under the previous procedure, and the second is an initial one for QPs being certified for the first time, having an expired certificate, or wishing to extend their professional qualification profiles. The article illustrates common mistakes made by certification applicants when preparing their documents. Furthermore, the authors describe the most prevalent knowledge gaps identified by testing. The abbreviated certification procedure ensured a sufficiently smooth transition to the EAEU requirements. For example, by 1 February 2023, 506 QPs were recertified for the next five-year period according to this procedure. This accounts for slightly more than half of all QPs certified in the Russian Federation according to the previous requirements. The total number of QPs certified according to the EAEU requirements in Russia in 2021β2022 is approximately 1.5 times higher than the number of QPs certified during the same period in 2014β2015.Conclusions. The updated procedure for QP certification has noticeably changed the occupational group of QPs formed in the Russian Federation in the last decade. The implementation of the new QP certification procedure has revealed several procedural issues that require additional explanation and clarification by the Ministry of Health of the Russian Federation
ΠΠ½Π°Π»ΠΈΡΠΈΡΠ΅ΡΠΊΠΈΠΉ ΠΎΠ±Π·ΠΎΡ ΠΏΡΠΎΡΠ΅Π΄ΡΡΡ Π°ΡΡΠ΅ΡΡΠ°ΡΠΈΠΈ ΡΠΏΠΎΠ»Π½ΠΎΠΌΠΎΡΠ΅Π½Π½ΡΡ Π»ΠΈΡ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΠΈΡΠ΅Π»Π΅ΠΉ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ ΡΡΠ΅Π΄ΡΡΠ² Π΄Π»Ρ ΠΌΠ΅Π΄ΠΈΡΠΈΠ½ΡΠΊΠΎΠ³ΠΎ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ Π² Π ΠΎΡΡΠΈΠΈ
Scientific relevance. In December 2020, the Russian Federation adopted the Eurasian Economic Union (EAEU) requirements. This has significantly changed the certification procedure for qualified persons (QPs) of manufacturers of medicinal products for human use in the Russian Federation. To accommodate these changes, the Russian regulatory framework needs further improvement.Aim. This study aimed to review the changes made to the mechanism of state regulation of medicines and to evaluate the impact on the pharmaceutical industry two years after the adoption of the current QP certification procedure.Discussion. This review compares two QP certification procedures established by Order No. 7n of the Ministry of Health of the Russian Federation dated 12 January 2021. The first is an abbreviated one for QPs certified under the previous procedure, and the second is an initial one for QPs being certified for the first time, having an expired certificate, or wishing to extend their professional qualification profiles. The article illustrates common mistakes made by certification applicants when preparing their documents. Furthermore, the authors describe the most prevalent knowledge gaps identified by testing. The abbreviated certification procedure ensured a sufficiently smooth transition to the EAEU requirements. For example, by 1 February 2023, 506 QPs were recertified for the next five-year period according to this procedure. This accounts for slightly more than half of all QPs certified in the Russian Federation according to the previous requirements. The total number of QPs certified according to the EAEU requirements in Russia in 2021β2022 is approximately 1.5 times higher than the number of QPs certified during the same period in 2014β2015.Conclusions. The updated procedure for QP certification has noticeably changed the occupational group of QPs formed in the Russian Federation in the last decade. The implementation of the new QP certification procedure has revealed several procedural issues that require additional explanation and clarification by the Ministry of Health of the Russian Federation.ΠΠΊΡΡΠ°Π»ΡΠ½ΠΎΡΡΡ. ΠΠΎΡΡΠ΄ΠΎΠΊ Π°ΡΡΠ΅ΡΡΠ°ΡΠΈΠΈ ΡΠΏΠΎΠ»Π½ΠΎΠΌΠΎΡΠ΅Π½Π½ΡΡ
Π»ΠΈΡ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΠΈΡΠ΅Π»Π΅ΠΉ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΡΡΠ΅Π΄ΡΡΠ² Π΄Π»Ρ ΠΌΠ΅Π΄ΠΈΡΠΈΠ½ΡΠΊΠΎΠ³ΠΎ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ (Π£Π) Ρ Π΄Π΅ΠΊΠ°Π±ΡΡ 2020 Π³. ΠΏΡΠ΅ΡΠ΅ΡΠΏΠ΅Π» ΡΡΡΠ΅ΡΡΠ²Π΅Π½Π½ΡΠ΅ ΠΈΠ·ΠΌΠ΅Π½Π΅Π½ΠΈΡ Π² ΡΠ²ΡΠ·ΠΈ Ρ ΠΏΠ΅ΡΠ΅Ρ
ΠΎΠ΄ΠΎΠΌ Π½Π° ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΡ ΠΠ²ΡΠ°Π·ΠΈΠΉΡΠΊΠΎΠ³ΠΎ ΡΠΊΠΎΠ½ΠΎΠΌΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΡΠΎΡΠ·Π° (ΠΠΠΠ‘). ΠΠΊΡΡΠ°Π»ΡΠ½ΠΎΠΉ ΡΠ²Π»ΡΠ΅ΡΡΡ Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎΡΡΡ Π΄Π°Π»ΡΠ½Π΅ΠΉΡΠ΅Π³ΠΎ ΡΠΎΠ²Π΅ΡΡΠ΅Π½ΡΡΠ²ΠΎΠ²Π°Π½ΠΈΡ ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΡΡΡΠ΅ΠΉ Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΠΎΠΉ Π±Π°Π·Ρ Π² ΡΠΎΡΡΠΈΠΉΡΠΊΠΎΠΌ Π·Π°ΠΊΠΎΠ½ΠΎΠ΄Π°ΡΠ΅Π»ΡΡΡΠ²Π΅.Π¦Π΅Π»Ρ. ΠΠ½Π°Π»ΠΈΠ· ΠΈΠ·ΠΌΠ΅Π½Π΅Π½ΠΈΠΉ Π² ΠΌΠ΅Ρ
Π°Π½ΠΈΠ·ΠΌΠ΅ Π³ΠΎΡΡΠ΄Π°ΡΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΡΠ΅Π³ΡΠ»ΠΈΡΠΎΠ²Π°Π½ΠΈΡ ΡΡΠ΅ΡΡ ΠΎΠ±ΡΠ°ΡΠ΅Π½ΠΈΡ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΡΡΠ΅Π΄ΡΡΠ², ΠΏΡΠΎΠΈΠ·ΠΎΡΠ΅Π΄ΡΠΈΡ
Π·Π° Π΄Π²Π° Π³ΠΎΠ΄Π° ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ Π½ΠΎΠ²ΠΎΠ³ΠΎ ΠΏΠΎΡΡΠ΄ΠΊΠ° Π°ΡΡΠ΅ΡΡΠ°ΡΠΈΠΈ ΡΠΏΠΎΠ»Π½ΠΎΠΌΠΎΡΠ΅Π½Π½ΡΡ
Π»ΠΈΡ, ΠΈ ΠΎΡΠ΅Π½ΠΊΠ° Π²Π»ΠΈΡΠ½ΠΈΡ ΡΡΠΈΡ
ΠΈΠ·ΠΌΠ΅Π½Π΅Π½ΠΈΠΉ Π½Π° ΡΠ°ΡΠΌΠ°ΡΠ΅Π²ΡΠΈΡΠ΅ΡΠΊΡΡ ΠΎΡΡΠ°ΡΠ»Ρ.ΠΠ±ΡΡΠΆΠ΄Π΅Π½ΠΈΠ΅. ΠΡΠ΅Π΄ΡΡΠ°Π²Π»Π΅Π½Ρ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΡ ΡΡΠ°Π²Π½ΠΈΡΠ΅Π»ΡΠ½ΠΎΠ³ΠΎ Π°Π½Π°Π»ΠΈΠ·Π° Π΄Π²ΡΡ
Π°Π΄ΠΌΠΈΠ½ΠΈΡΡΡΠ°ΡΠΈΠ²Π½ΡΡ
ΠΏΡΠΎΡΠ΅Π΄ΡΡ Π°ΡΡΠ΅ΡΡΠ°ΡΠΈΠΈ Π£Π, ΡΡΡΠ°Π½ΠΎΠ²Π»Π΅Π½Π½ΡΡ
ΠΏΡΠΈΠΊΠ°Π·ΠΎΠΌ ΠΠΈΠ½Π·Π΄ΡΠ°Π²Π° Π ΠΎΡΡΠΈΠΈ ΠΎΡ 12.01.2021 β 7Π½: ΡΡΠΊΠΎΡΠ΅Π½Π½ΠΎΠΉ (Π΄Π»Ρ Π£Π, Π°ΡΡΠ΅ΡΡΠΎΠ²Π°Π½Π½ΡΡ
ΡΠ°Π½Π΅Π΅) ΠΈ ΠΏΠ΅ΡΠ²ΠΈΡΠ½ΠΎΠΉ (Π΄Π»Ρ Π£Π, Π°ΡΡΠ΅ΡΡΡΠ΅ΠΌΡΡ
Π²ΠΏΠ΅ΡΠ²ΡΠ΅; Π΄Π»Ρ Π£Π, ΡΡΠΎΠΊ Π΄Π΅ΠΉΡΡΠ²ΠΈΡ Π°ΡΡΠ΅ΡΡΠ°ΡΠΈΠΈ ΠΊΠΎΡΠΎΡΡΡ
ΠΈΡΡΠ΅ΠΊ; Π² ΡΠ»ΡΡΠ°Π΅ Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎΡΡΠΈ ΡΠ°ΡΡΠΈΡΠ΅Π½ΠΈΡ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π΅Π½Π½ΡΡ
ΡΠΏΠ΅ΡΠΈΠ°Π»ΠΈΠ·Π°ΡΠΈΠΉ Π£Π). ΠΡΠΈΠ²Π΅Π΄Π΅Π½Ρ ΡΠΈΠΏΠΈΡΠ½ΡΠ΅ ΠΎΡΠΈΠ±ΠΊΠΈ Π·Π°ΡΠ²ΠΈΡΠ΅Π»Π΅ΠΉ ΠΏΡΠΈ ΠΎΡΠΎΡΠΌΠ»Π΅Π½ΠΈΠΈ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΠΎΠ², ΠΎΠΏΠΈΡΠ°Π½Ρ Π½Π°ΠΈΠ±ΠΎΠ»Π΅Π΅ ΡΠ°ΡΠΏΡΠΎΡΡΡΠ°Π½Π΅Π½Π½ΡΠ΅ ΠΏΡΠΎΠ±Π΅Π»Ρ Π·Π½Π°Π½ΠΈΠΉ Π·Π°ΡΠ²ΠΈΡΠ΅Π»Π΅ΠΉ, Π²ΡΡΠ²Π»ΡΠ΅ΠΌΡΠ΅ ΠΏΡΠΈ ΡΠ΅ΡΡΠΎΠ²ΠΎΠΌ ΠΊΠΎΠ½ΡΡΠΎΠ»Π΅. ΠΡΠΌΠ΅ΡΠ΅Π½ΠΎ, ΡΡΠΎ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ ΡΡΠΊΠΎΡΠ΅Π½Π½ΠΎΠΉ ΠΏΡΠΎΡΠ΅Π΄ΡΡΡ Π°ΡΡΠ΅ΡΡΠ°ΡΠΈΠΈ ΠΏΠΎΠ·Π²ΠΎΠ»ΠΈΠ»ΠΎ Π΄ΠΎΡΡΠ°ΡΠΎΡΠ½ΠΎ ΠΏΠ»Π°Π²Π½ΠΎ ΠΎΡΡΡΠ΅ΡΡΠ²ΠΈΡΡ ΠΏΠ΅ΡΠ΅Ρ
ΠΎΠ΄ Π½Π° ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΡ ΠΊ Π£Π Π² ΠΠΠΠ‘. Π’Π°ΠΊ, ΠΏΠΎ ΡΠΎΡΡΠΎΡΠ½ΠΈΡ Π½Π° 01.02.2023 ΠΏΠΎ Π΄Π°Π½Π½ΠΎΠΉ ΠΏΡΠΎΡΠ΅Π΄ΡΡΠ΅ Π½Π° Π½ΠΎΠ²ΡΠΉ ΠΏΡΡΠΈΠ»Π΅ΡΠ½ΠΈΠΉ ΠΏΠ΅ΡΠΈΠΎΠ΄ Π±ΡΠ»ΠΎ Π·Π°Π½ΠΎΠ²ΠΎ Π°ΡΡΠ΅ΡΡΠΎΠ²Π°Π½ΠΎ 506 ΡΠ΅Π»ΠΎΠ²Π΅ΠΊ, ΡΡΡΡ Π±ΠΎΠ»Π΅Π΅ ΠΏΠΎΠ»ΠΎΠ²ΠΈΠ½Ρ Π²ΡΠ΅Ρ
ΡΠ°Π½Π΅Π΅ Π°ΡΡΠ΅ΡΡΠΎΠ²Π°Π½Π½ΡΡ
Π£Π Π² Π ΠΎΡΡΠΈΠΉΡΠΊΠΎΠΉ Π€Π΅Π΄Π΅ΡΠ°ΡΠΈΠΈ. ΠΠ±ΡΠ΅Π΅ ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²ΠΎ Π°ΡΡΠ΅ΡΡΠΎΠ²Π°Π½Π½ΡΡ
Π² ΠΊΠ°ΡΠ΅ΡΡΠ²Π΅ Π£Π Π·Π° ΠΏΠ΅ΡΠΈΠΎΠ΄ 2021β2022 Π³Π³. Π²ΡΡΠΎΡΠ»ΠΎ Π² 1,5 ΡΠ°Π·Π° Π² ΡΡΠ°Π²Π½Π΅Π½ΠΈΠΈ Ρ ΡΠ°ΠΊΠΈΠΌ ΠΆΠ΅ ΠΏΠ΅ΡΠΈΠΎΠ΄ΠΎΠΌ Π² 2014β2015 Π³Π³.ΠΡΠ²ΠΎΠ΄Ρ. ΠΡΠΌΠ΅ΡΠ΅Π½ΠΎ, ΡΡΠΎ Π²Π²Π΅Π΄Π΅Π½ΠΈΠ΅ ΠΎΠ±Π½ΠΎΠ²Π»Π΅Π½Π½ΠΎΠ³ΠΎ ΠΏΠΎΡΡΠ΄ΠΊΠ° Π°ΡΡΠ΅ΡΡΠ°ΡΠΈΠΈ Π² Π ΠΎΡΡΠΈΠΉΡΠΊΠΎΠΉ Π€Π΅Π΄Π΅ΡΠ°ΡΠΈΠΈ ΠΏΡΠΈΠ²Π΅Π»ΠΎ ΠΊ Π·Π°ΠΌΠ΅ΡΠ½ΡΠΌ ΠΈΠ·ΠΌΠ΅Π½Π΅Π½ΠΈΡΠΌ ΡΡΠΎΡΠΌΠΈΡΠΎΠ²Π°Π½Π½ΠΎΠΉ Π² ΠΏΠΎΡΠ»Π΅Π΄Π½Π΅Π΅ Π΄Π΅ΡΡΡΠΈΠ»Π΅ΡΠΈΠ΅ ΠΏΡΠΎΡΠ΅ΡΡΠΈΠΎΠ½Π°Π»ΡΠ½ΠΎΠΉ Π³ΡΡΠΏΠΏΡ Π£Π. ΠΡΠΈ Π°Π½Π°Π»ΠΈΠ·Π΅ Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΠΎΠΉ Π±Π°Π·Ρ Π²ΡΡΠ²Π»Π΅Π½ ΡΡΠ΄ ΠΏΡΠΎΡΠ΅Π΄ΡΡΠ½ΡΡ
Π²ΠΎΠΏΡΠΎΡΠΎΠ², ΠΊΠΎΡΠΎΡΡΠ΅ ΡΡΠ΅Π±ΡΡΡ Π΄ΠΎΠΏΠΎΠ»Π½ΠΈΡΠ΅Π»ΡΠ½ΡΡ
ΡΡΠΎΡΠ½Π΅Π½ΠΈΠΉ ΠΈ ΡΠ°Π·ΡΡΡΠ½Π΅Π½ΠΈΠΉ ΠΠΈΠ½Π·Π΄ΡΠ°Π²Π° Π ΠΎΡΡΠΈΠΈ ΠΏΡΠΈ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΠΈ Π΄Π΅ΠΉΡΡΠ²ΡΡΡΠ΅Π³ΠΎ ΠΏΠΎΡΡΠ΄ΠΊΠ° Π°ΡΡΠ΅ΡΡΠ°ΡΠΈΠΈ Π£Π
Examination of soil for the presence of helminths eggs
The method of research of tests of the soil on eggs of helminths which sur- passes the method of Romanenko offered earlier in the efficiency is offered and can be used in practice and when carrying out scientific researches. This method was applied to inspection of objects of environment of Kazan city and allowed to reveal big impurity eggs of geohelminths. The developed method allowed to reveal in addition about 36 % of eggs of ascarids than on Romanenko's method that is caused by application of several components in flotation liquid: solutions of chlo- ride of zinc and sodium chloride and glycerin. Components of the flotation liquid don't break morphology of eggs of parasites and don't create difficulties with mor- phological identification of the helminth
Draft genome sequence data of Lysinibacillus fusiformis strain GM, isolated from potato phyllosphere as a potential probiotic
Here we present the morphological and physiological properties of isolated Lysinibacillus fusiformis strain GM, its draft genome sequence as well as annotation and analysis of its genome. Initial analysis of MALDI-TOF mass spectrometry, 16S rRNA gene analysis and in silico DNA-DNA hybridization revealed that the strain belongs to the species Lysinibacillus fusiformis. The 4,678,122β―bp draft genome consist of 17 scaffolds encoding 4588 proteins and 137 RNAs. Annotation of the genome sequence revealed cellulase and protease encoding genes, genes of adhesion proteins and putative genes responsible for the biosynthesis of antimicrobial metabolites. The Whole Genome Shotgun project has been deposited at DDBJ/EMBL/GenBank under the accession number NTMQ00000000.1 (https://www.ncbi.nlm.nih.gov/nuccore/NZ_NTMQ00000000.1). Keywords: Lysinibacillus fusiformis, Probiotic, Cellulase, Illumina MiSeq, In silico DNA-DNA hybridizatio