The Integrated Model of Quality Management System of Laboratory Studies of Medicines (Review)

Селезнева, А. И.; Смирнов, В. А.; Горячкин, В. В.; Чадова, Н. Н.; Поляков, С. В.; Шестаков, В. Н.; Абрамович, Р. А.

doi:10.33380/2305-2066-2021-10-3-148-165

Cited by 5 publications

(2 citation statements)

References 18 publications

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“…Among them, Selezneva et al's study was dedicated to the role of laboratory research in ensuring the quality of domestic medicines. It also reviewed and analyzed regulatory documents and current publications on the subject [1]. e purpose of Kashirina et al 's study was to study the current industrial practice of drug quality risk management in Russian pharmaceutical companies.…”

Section: Related Workmentioning

confidence: 99%

Artificial Intelligence-Based Drug Production Quality Management Data

2022

Mathematical Problems in Engineering

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As a special commodity, medicine plays a vital role in people’s healthy life. The basic effects of drugs are excitation and inhibition. Under the action of drugs, any function that can enhance or increase the function of the body’s original tissues and organs is called excitement. On the contrary, any function that can weaken or reduce the function of the original tissues and organs of the body is called inhibition. The nature of action of drugs has three aspects: regulatory function; antipathogen and antitumor; and complementary therapy. If there is a problem with the quality and safety of medicines, it is tantamount to making money and killing people. Based on artificial intelligence, this paper analyzes the current situation and improvement strategies of quality management in pharmaceutical production management enterprises and proposes how to reduce the risk of drug safety with the assistance of artificial intelligence technology. The experimental results in this paper show that the sales of heparin sodium APIs were 2.099 billion yuan, accounting for 91.6% of the operating income in 2015, when company A had not conducted a drug risk assessment in 2015. After the outbreak of drug risks, the sales in 2016 were 1.743 billion yuan, accounting for 77.1% of the operating income in 2016. After the final implementation of the measures, the sales in 2019 were 4.743 billion yuan, accounting for 329.1% of the operating income in 2016. The research method in this paper can improve the hidden safety problems of drugs more efficiently, and it can improve the profit while ensuring the safety.

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Section: Related Workmentioning

confidence: 99%

Artificial Intelligence-Based Drug Production Quality Management Data

2022

Mathematical Problems in Engineering

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“…Effective use of digital technologies in the development of regions requires adequate infrastructure, interregional cooperation, and the development of both general policies that take into account the interests of all stakeholders and flexible policies adapted to the specific needs of each sector of the economy (Simonen et al 2016 ; Selezneva et al 2021 ; Shestakov and Podpruzhnikov 2020 ). In parallel, the main factor defining the degree of development of various regions is access to high-speed Internet connection (Lin et al 2017 ), which reinforces the significance of digital literacy and digital education (Interreg Europe Report 2017 ).…”

Section: Literature Reviewmentioning

confidence: 99%

Digitalization and its impact on regional economy transformation mechanisms

Demin

Mikhaylova

Pyankova³

2022

Int J Syst Assur Eng Manag

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This study aimed to identify which digital transformation areas are prioritized in regions with different levels of innovative development. Based on the analysis of statistical information presented in reports on the control indicators of regional economy transformation, the most innovative regions were distinguished. The study scrutinized the correlation of regional economic development with the presence/absence of high-tech industries in the area, as well as compared digital skills of residents of innovation clusters with residents of other regions using data structuring and the method of analytical studies. To achieve the ultimate study goal, a number of freelancers’ profiles available on freelance marketplaces was analyzed in terms of the following categories of digital skills: programming (regardless of the programming language), translation, copywriting, SEO and SMM, design, engineering services. The sample included only the profiles of individuals registered no later than 2018 who successfully completed at least three projects. An in-depth consideration of all these data allowed developing recommendations on digitalization of the regional economy, taking into account the number of inhabitants in the region and their density. As a tool for the transformation, this study proposed the four-stage Smart Region model. In sum, the carried-out investigation revealed that the benefits of digitalization are more visible in innovative regions. Correspondingly, the regions with innovative industries are characterized by higher digital skills in the field of engineering. The obtained findings can be used as a basis for management decisions by politicians and IT industry workers striving to promote the implementation of modern technologies.

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Development of Optimal Technology for Drying Herbal Medicinal Raw Materials from Autumn Wormwood (<i>Artemisia serotina</i> Bunge) Based on Comparative Analysis

Kadyrbay,

Sakipova,

Krishtanova

et al. 2023

Razrabotka i registraciâ lekarstvennyh sredstv

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Introduction. Choosing the optimal method for drying medicinal plants is an important aspect of obtaining herbal materials of pharmacopoeial quality. At the site of the pharmaceutical enterprise Fitoleum LLP (Esik, Kazakhstan), a technology for obtaining herbal materials from autumn wormwood (Artemisia serotina Bunge) was developed, within the framework of which the optimal drying method was studied using IR radiation, convective drying and shadow drying in natural conditions. In parallel with the experimental approach, a method for simulating drying conditions was implemented. The development of technology for the obtaining of herbal materials is implemented using the "Quality by Design" concept, one of the principles of which is the modeling of experiments (Design of experiments, DoE). The advantage of modeling when studying the processes is that this technique allows you to simultaneously analyze several input parameters and their impact on quality indicators, while significantly reducing the number of experiments.Aim. To choose the optimal method for drying autumn wormwood herb for further production of herbal medicine or herbal materials.Materials and methods. During the experiment, the following equipment was used: a manual harvester for collecting plants, pallets or racks with a mesh bottom, infrared substrates, a convective drying oven, racks with pallets under a canopy in natural conditions, a grass cutter, vibrating sieves. Also, the study was carried out in accordance with the principles of the "Quality by Design" concept using the Minitab Statistical Software 21 program, using a statistical tool – Design of experiments (DoE).Results and discussion. The results of studies of various drying methods have shown that the most optimal is drying with IR radiation, which allows to maintain the content of essential oils (the main group of biologically active substances) at the optimal level – about 1,7 % with a raw material moisture content of no more than 13 %. The data obtained by simulating the experiment in the Minitab program were comparable to the results of the classical experimental design. The optimal method and technological parameters for drying autumn wormwood have been established – the use of IR radiation, temperature of 35–45 °C and drying time of 14–17 hours. Comparable data on the studied technological parameters of three sequentially produced series were obtained and the validity of the technological process for drying autumn wormwood was confirmed.Conclusion. Comparative analysis of the methods of drying medicinal plants – IR radiation, convective and shadow drying in natural conditions – of autumn wormwood (Artemisia serotina Bunge) was carried out. It has been established that the maximum content of essential oils (as the main group of biologically active substances) in raw materials is observed when using drying using IR radiation at a temperature of 35–45 °C for 14– 17 hours. At the same time, the residual moisture content of the drug is no higher than 13 %, which corresponds to pharmacopoeial requirements. Conducted studies of predicting optimal drying parameters using the Minitab Statistical Software 21 program showed comparability with the experimental results. Based on the results obtained, an optimal method for drying autumn wormwood herb was proposed for use in production and obtaining pharmacopoeial quality medicinal products.

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The Integrated Model of Quality Management System of Laboratory Studies of Medicines (Review)

Cited by 5 publications

References 18 publications

Artificial Intelligence-Based Drug Production Quality Management Data

Artificial Intelligence-Based Drug Production Quality Management Data

Digitalization and its impact on regional economy transformation mechanisms

Development of Optimal Technology for Drying Herbal Medicinal Raw Materials from Autumn Wormwood (<i>Artemisia serotina</i> Bunge) Based on Comparative Analysis

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