scholarly journals Assessment of the equivalence of technical materials of analogous pesticides to original active substances on the basis of “mutagenicity” criterion

2019 ◽  
Vol 17 (2) ◽  
pp. 101-112
Author(s):  
Nataliya A. Ilyushina

In the Russian Federation about 600 active ingredients of pesticides are currently registered. A large share among them is occupied by analogous pesticides (generics), which may differ in their properties from the original products due to an increased level or altered composition of impurities. Therefore, to ensure the safe use of analogous pesticides, it is necessary to evaluate their chemical and toxicological equivalence. The analysis of algorithms described in international documents and implemented in practice in some countries for determination of the equivalence of technical materials of analog pesticides is presented. Particular attention is paid to the evaluation of pesticide safety on the basis of the mutagenicity criterion. The applicability of different methods for genotoxic activity determination to confirm the equivalence of active substances of pesticides-analogues to patented products is discussed. A brief review of the results of the researches confirming the need to assess the genotoxicity of all technical materials of analogous pesticides with a view to preventing the entry of hazardous substances into the consumer market is presented.

2021 ◽  
Vol 21 (3) ◽  
pp. 142-157
Author(s):  
N. A. Gavrilova ◽  
Yu. V. Olefir ◽  
V. A. Merkulov ◽  
V. P. Bondarev ◽  
E. M. Rychikhina ◽  
...  

Vaccines by different manufacturers are available for most of the vaccine-preventable infections covered by the National Immunisation Schedule of the Russian Federation. Determination of the possibility of replacing a vaccine in the case of routine or emergency vaccination still remains a challenging issue. The aim of the study was to substantiate the problem of vaccine interchangeability, outline specific challenges and ways of solving them, analyse criteria underlying evaluation of vaccine interchangeability in Russia, and international experience in this area. The procedure for determining the interchangeability of biological products, including vaccines, was established in the Decree of the Government of the Russian Federation of 5 September 2020, No. 1360 “On the procedure for determination of interchangeability of medicinal products for human use”. The paper analyses the applicability of the official criteria for interchangeability of biological products, including vaccines. It outlines the main problems of performing evaluation of vaccine interchangeability in accordance with the established criteria. It is concluded that the vaccine interchangeability criteria need to be clarified in order to allow for assessment of comparability of active substances, and comparison of efficacy, safety, and immunogenicity of vaccines, taking into account vaccination schedules for different age groups. The possibility of evaluating interchangeability based on the results of post-authorisation studies also needs clarification. It is also necessary to align patient information leaflets for interchangeable vaccines.


2020 ◽  
pp. 105-116
Author(s):  
N. I. Shagaida

The article clarifies the concept of “agricultural holding”, using an approach to assessing the size on the basis of the total revenue of all agricultural organizations within the agricultural holding. It has been revealed that only 100 of the total number of agricultural holdings that were identified can be attributed to large business entities. They comprise about 3% of agricultural organizations in the country, while their share in the proceeds is about 37%. A large share of agricultural holdings — large business subjects under the control of Russian entities operate in one, and under the control of foreign legal entities — in three or more regions of the Russian Federation. Vertical integration within the framework of large agricultural holdings with different schemes for including the stages of processing and sale of products produced in their agricultural organizations allows them to receive advantages. Strengthening the role of large business entities in agriculture puts on the agenda the issue of differentiating approaches to taxation and state support in agriculture, depending on the size of the companies’ agricultural businesses.


2020 ◽  
Vol 962 (8) ◽  
pp. 24-37
Author(s):  
V.E. Tereshchenko

The article suggests a technique for relation global kinematic reference system and local static realization of global reference system by regional continuously operated reference stations (CORS) network. On the example of regional CORS network located in the Novosibirsk Region (CORS NSO) the relation parameters of the global reference system WGS-84 and its local static realization by CORS NSO network at the epoch of fixing stations coordinates in catalog are calculated. With the realization of this technique, the main parameters to be determined are the speed of displacement one system center relativly to another and the speeds of rotation the coordinate axes of one system relatively to another, since the time evolution of most stations in the Russian Federation is not currently provided. The article shows the scale factor for relation determination of coordinate systems is not always necessary to consider. The technique described in the article also allows detecting the errors in determining the coordinates of CORS network in global coordinate system and compensate for them. A systematic error of determining and fixing the CORS NSO coordinates in global coordinate system was detected. It is noted that the main part of the error falls on the altitude component and reaches 12 cm. The proposed technique creates conditions for practical use of the advanced method Precise Point Positioning (PPP) in some regions of the Russian Federation. Also the technique will ensure consistent PPP method results with the results of the most commonly used in the Russian Federation other post-processing methods of high-precision positioning.


2020 ◽  
Vol 1 ◽  
pp. 32-36
Author(s):  
I. V. Botantsov ◽  

According to the Constitution of the Russian Federation, every citizen has the right to freedom of movement on its territory, but due to the fact that minors cannot be held accountable for their actions, there is a need to control their movement by legal representatives. The practical determination of the age of independent travel of minors and the issues of drawing up documents by parents authorizing them to do so are the subjects of disputes that are subject to judicial resolution. The article provides an analysis of the relevant practice, accompanied by the author's comments.


Author(s):  
Alexander Fedyunin

The subject of this research is the issues emerging in consideration of jurisdiction of the material on extradition of a foreign citizen by the Russian Federation. The article touches upon the peculiarities of national and territorial aspect of jurisdiction, and its specific regulation in the criminal procedure law. The article employs the general scientific and private scientific methods, such as scientific analysis, generalization, comparative-legal, formal-logical, which allowed to most fully reflect the essence and problematic aspects of the selected topic. The question at hand is of major importance for the theory of criminal procedure and law enforcement practice, as the mistakes in determination of jurisdiction of the material are a severe violation of the rights, including the convict, and entail the unconditional annulment of court decision. The analysis of the most common mistakes occurred in application of the norms regulating the jurisdiction of extradition of a foreign citizen convicted by the court of the Russian Federation, as well as theoretical issues associated with determination of the court that deals with the particular issue allows outlining the vector and finding solution to the indicated problems.


2020 ◽  
Vol 23 (6) ◽  
pp. 40-52
Author(s):  
K. A. Kuts

The determination of operation area from en-route alternates for long-range airline aircraft is an important aspect of ensuring safety of the upcoming flight. In the domestic and foreign methodological literature on flight planning, including the guidance material for flight planning systems, there is no single reasonable algorithm for constructing operation areas of long-range aircraft, including the use of the EDTO-ETOPS rules. The lack of methodological materials leads to the «free» values determination of areas of operation by airlines for their long-range aircraft while building routes, in particular, when determining the areas of operation on the route, the decrease in the aircraft weight during fuel combustion is ignored. A big question is also the «initial» mass calculations to determine the value of operation areas. The article identifies shortcomings of existing algorithm for identifying the areas of operation based on the fundamental methods for determining area of operation. Microsoft Excel 2019 has been used to perform a polynomial approximation of the table-specific function of the dependence of operation radius on the mass of a long-range aircraft. Based on the certain equations, more advanced algorithm to determine areas of operation has been developed. The new algorithm pays special attention to the selection of the original value of operation area. The calculations in this article are made for the Boeing 777 as the main type of long-range aircraft operated by airlines in the Russian Federation. The developed algorithm increases the flexibility of the route by increasing the radius of operation areas from en-route alternates and can be used in flight planning systems of airlines.


2019 ◽  
Vol 19 (1-2) ◽  
pp. 13-18
Author(s):  
D. A Zhdanov ◽  
V. B Braslavsky

The article is devoted to the development of new and perspective for the State Pharmacopoeia of the Russian Federation (SP RF) techniques for determining of the moisture (loss on drying) of medicinal plant raw materials of the morphological group “Fruit” and medicinal plant preparations by the use of infrared thermogravimetric (IRTGM) method. The techniques for determination of moisture (loss on drying) IRTGM-method as exemplified by the fruit of the following medicinal plants: Silybum marianum (L.) Gaertn., Rosa cinnamomea L. and Anethum graveolens L. were developed. The comparable results for determining of the moisture (loss on drying) of the medicinal plant raw materials of investigated plants were obtained by means of two methods: IRTGM and pharmacopoeial method, which allow us to recommend the developed techniques for inclusion into the relevant monographs of the State Pharmacopoeia of the Russian Federation.


2020 ◽  
Vol 164 ◽  
pp. 09040
Author(s):  
Valentina Karginova-Gubinova ◽  
Anton Shcherbak ◽  
Sergey Tishkov

Financing capital-intensive projects in the green economy is possible through green bonds. The assessment of the economic efficiency of the green bond market, the determination of its role in ensuring the energy and economic security of the regions and the development of directions and instruments for improving the efficiency and significance of the market for the Russian Federation are the aim of the study. The methodology involved the determination of the autocorrelation presence in the calendar series of bond yields using the Broysch-Godfrey LM test, the application of applied statistics methods to verify the existence of calendar effects on the stock exchange and analyze market reviews. Data on the green bond market were compared with data on other bonds. Market performance calculations were based on the S&P Green Bond Index and S&P 500 Bond Index. Features and benefits of green bonds as an instrument to ensure regional security were identified. The lack of market efficiency for green and other bonds, even in a weak form, was shown. The necessary institutional changes to improve the efficiency of the green bond market and develop it in the Russian Federation have been proposed. The findings are of theoretical importance, complementing the work on testing the hypothesis of an effective market, and of practical importance in the form of recommendations for on market improving.


Author(s):  
Воронин ◽  
Ivan Voronin ◽  
Бадак ◽  
Igor Badak ◽  
Прохоренко ◽  
...  

There were 105 patients with shoulder replacement under our supervision (terms of supervision were up to 10 years). There were 43 men and 62 women. Age of patients was from 29 to 80 years. Two ways of optimization of shoulder replacement are offered: “Method of preoperative determination of the sizes of a head of shoulder joint endoprosthesis” (Patent of the Russian Federation N 2469670 d.d. 12.20.2012) and “Method for intraoperative navigation of a shoulder stem of joint” (Patent of the Russian Federation N 2467725 d.d. 11.27.2012). We reached the improvement of quality of the operation due to the fact of an installation of the implants which are as much as possible close to the anatomy of a normal shoulder joint by size and position.


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