• Korean Journal of Clinical Pharmacy
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• v.34 no.1
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• pp.39-61
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• 2024

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA's programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA's regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

• Journal of Engineering Education Research
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• v.11 no.3
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• pp.5-11
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• 2008

Far greater than ever before is the present industrial demand for skilled professionals in innovative product design and development. Yet there is an apparent lack of a sufficient curricular provision for training design professionals in almost all engineering schools. The present study is to propose a systematic procedure for developing a strategy for building an innovative product design curriculum and demonstrate its application. The procedure consists of three major steps: strategic element derivation, task formulation, and task execution roadmap construction. The proposed procedure was applied to develop a modular curriculum (a cluster of several related courses) covering various subjects in relation to innovative product design and development. The procedure seems quite effective and useful for developing a curriculum that is strategically well differentiated based on the unique characteristics of a particular educational institute and its applicability seems not limited to a specific domain.

• Journal of the Economic Geographical Society of Korea
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• v.24 no.3
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• pp.232-242
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• 2021

The aim of this article is to examine the role of Gyeonggi Province in the industrial development in the Republic of Korea by taking a case study of the program of the national innovative cluster (NIC). In such program which has been for the purpose of the regional industrial development for non-Seoul metropolitan regions (N-SMRs) since 2018, the total firms' transactions were highly focused upon Gyeonggi Province and other Seoul metropolitan regions (SMRs). Especially, firms' transactions in 5 clusters of the total 14 clusters concentrated on Gyeonggi Province. Within this context, the future direction of this policy program for the regional industrial development and the national balanced development is more focused upon a win-win strategy between the SMR and N-SMRs rather than the dichotomy between them.

• International Journal of Computer Science & Network Security
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• v.21 no.7
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• pp.125-132
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• 2021

Rapid growth of the higher education role in ensuring the socio-economic and innovative development of the national economy in the context of the development of the information society and the knowledge economy is observed. Achieving positive synergistic effects of the higher education development requires proper funding for university education and research. The existing funding models for national higher education systems in a number of developing countries need modernization in accordance with the modern challenges of economic and innovative development. The purpose of the article is to formulate theoretical - methodological and applied foundations for the development and implementation of the integrated model of the higher education financing under the Quadruple Helix concept. At the center of the developed model are the areas of interaction identified by the authors, namely: Personnel, Science, Management, Innovation, Social area. This made it possible to specify the interests of all stakeholders and orient the activities of higher education institutions to the satisfaction of these interests. Effective implementation of the integrated Model of the higher education financing requires increasing the level of investment attractiveness and practical value of university research; activation of innovative development of enterprises; state stimulation of business participation in university research and education; harmonization of current legislation with EU standards. Implementation of the Model will diversify sources of funding for universities, increase their level of economic security and achieve integrated synergies from the interaction of universities, business, government and the public (as the main stakeholders within the Quadruple Helix concept).

• Journal of Society of Preventive Korean Medicine
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• v.25 no.2
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• pp.1-11
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• 2021

Objective : The purpose of this study is to analyze Korean patients' characteristics, who were concurrently treated with both Korean herbal medicines and Western chemical medicines using nation-wide database. Method : Using the patients sample data (HIRA-NPS 2018) provided by Health Insurance Review and Assessment Service, a group of patients who co-administered Korean herbal and Western medicines was selected, and their basic characteristics, diagnosis, and prescribed chemical medicines were analyzed. Results : Out of the 1,481,921 sample population, 17,629 patients (1.2%) were selected as a concurrent medication group. Compared to the whole sample, the concurrent medication group was composed of more women (65.8% vs. 51.1%), the more elderly people (65 or older years old) (44.5% vs. 14.6%), and the higher prevalence of chronic diseases (49.1% vs. 22.2%). The most frequent diagnosis treated with Western medicines was mental and behavioral disorders, musculoskeletal and circulatory disorders. Frequently used drugs among concurrent medication group were anti-anxiety drugs, gastric ulcer treatment drugs, and senile diseases treatment drugs. Conclusion : The evidence reported in this study is expected to provide herb-drug interaction researchers with important reference to set the priorities of research topics in the future.

• International Journal of Computer Science & Network Security
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• v.21 no.8
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• pp.97-104
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• 2021

The key challenges and problematic aspects of the formation of intellectually and innovation-oriented strategies of regional entities at the present stage of their development are considered. The main tasks that arise in the process of strategizing the potential-forming development of regional economic systems in the context of digitalization are identified. The list of key organizational and economic directions of strategic character of providing intellectual and innovative development of regional economic systems is formed, which includes clustering of centers of high-tech development of regions, creation of creative hubs, development of knowledge infrastructure and improvement of interregional cooperation; a brief description of each of the presented strategic organizational and economic directions is given. Based on the analysis, the key strategic guidelines for the development of regional economic entities in the context of digitalization under the influence of potential-forming determinants, which form the content basis for further processes of strategizing qualitative aspects of development of specific regional entities.

• International Journal of Computer Science & Network Security
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• v.22 no.8
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• pp.153-162
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• 2022

Relevance. Innovative activities in education should be aimed at ensuring the comprehensive development of the individual and professional development of students. The main idea of modular technology is that the student should learn by himself, and the teacher manages his learning activities. The advantage of modular technology is the ability of the teacher to design the study of the material in the most interesting and accessible forms for this part of the study group and at the same time achieve the best learning results. Innovative Moodle technology. it is gaining popularity every day, significantly expanding the space of teaching and learning, allowing students to study inter-faculty university programs in depth. The purpose of this study is to assess the quality of implementation of the e-learning system Moodle. The study was conducted at the South Ukrainian National Pedagogical University named after K. D. Ushinsky in order to identify barriers to the effective implementation of innovative distance learning technologies Moodle and introduce a new model that will have a positive impact on the development of e-learning. Methodology. The paper used a combination of theoretical and empirical research methods. These include: scientific analysis of sources on this issue, which allowed us to formulate the initial provisions of the study; analysis of the results of students 'educational activities; pedagogical experiment; questionnaires; monitoring of students' activities in practical classes. Results. This article evaluates the implementation of the principles of distance learning in the process of teaching and learning at the University in terms of quality. The experiment involved 1,250 students studying at the South Ukrainian National Pedagogical University named after K. D. Ushinsky. The survey helped to identify the main barriers to the effective implementation of modern distance learning technologies in the educational process of the University: the lack of readiness of teachers and parents, the lack of necessary skills in applying computer systems of online learning, the inability to interact with the teaching staff and teachers, the lack of a sufficient number of academic consultants online. In addition, internal problems are investigated: limited resources, unevenly distributed marketing advantages, inappropriate administrative structure, and lack of innovative physical capabilities. The article allows us to solve these problems by gradually implementing a distance learning model that is suitable for any university, regardless of its specialization. The Moodle-based e-learning system proposed in this paper was designed to eliminate the identified barriers. Models for implementing distance learning in the learning process were built according to the CAPDM methodology, which helps universities and other educational service providers develop and manage world-class online distance learning programs. Prospects for further research focus on evaluating students' knowledge and abilities over the next six months after the introduction of the proposed Moodle-based program.

• Journal of Distribution Science
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• v.11 no.6
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• pp.21-30
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• 2013

Purpose - This paper examines product design management, the current design focus of which has shifted to the need to produce innovation applications that can effectively respond to the market's consumption changes in a timely manner. Research design, data, methodology - This study discusses several methodologies that are widely used in experimental processes, such as fuzzy theory, multi-criteria decision-making theory, and managing decision making. The designers will better understand their customers by applying these methodologies. This study examines how the current trend in product innovation design observes customer needs, controls innovation, and stimulates design ability. Results - This paper takes innovative telephone design as an experimental case to investigate how to create a product using market-oriented and customized management concepts and creative design abilities. Conclusions - If accompanied by an innovative product value chain, a product can further the development of enterprise management, now the main element of every developed country's social and economic development.

• Atmosphere
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• v.30 no.4
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• pp.439-454
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• 2020

This study investigates the change in the fine particulate matter (PM2.5) concentration and World Health Organization (WHO) air quality index (AQI) in East Asia (EA) under Shared Socioeconomic Pathways (SSPs). AQI is an indicator of increasing levels about health concern, divided into six categories based on PM2.5 annual concentrations. Here, we utilized the ensemble results of UKESM1, the climate model operated in Met Office, UK, for the analysis of long-term variation during the historical (1950~2014) and future (2015~2100) period. The results show that the spatial distributions of simulated PM2.5 concentrations in present-day (1995~2014) are comparable to observations. It is found that most regions in EA exceeded the WHO air quality guideline except for Japan, Mongolia regions, and the far seas during the historical period. In future scenarios containing strong air quality (SSP1-2.6, SSP5-8.5) and medium air quality (SSP2-4.5) controls, PM2.5 concentrations are substantially reduced, resulting in significant improvement in AQI until the mid-21st century. On the other hand, the mild air pollution controls in SSP3-7.0 tend to lead poor AQI in China and Korea. This study also examines impact of increased in PM2.5 concentrations on downward shortwave energy at the surface. As a result, strong air pollution controls can improve air quality through reduced PM2.5 concentrations, but lead to an additional warming in both the near and mid-term future climate over EA.

• Computational Structural Engineering
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• v.36 no.3
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• pp.4-10
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• 2023