• 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.

• The Journal of Information Systems
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• v.8 no.2
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• pp.145-168
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• 1999

There are still occurring aviation accidents in spite of great preventing efforts all over the world. This paper contains some methods to prevent aircrafts deficiencies and accidents. First part of this paper refers to the background of those aviation deficiencies on mechanical, human and environment structures which influence directly to the air accidents and general survey on various theories of the aircraft's systems. On the way we discussed the general situations of the air tool's deficiencies which cause tragic accidents to the human lives and assets. After analysis on the situations we suggest the new systems which would forecast more detail accuracies concerned air elements for the safety flying. Then we introduce the following new systems resulting from the forecasting which can solve problems on aircraft deficiencies and complex interrelationships among air accidental factors. To simplify the complex systems, we needed to build the mechanical and organizational database for maintaining the procedures of the past troubleshooting on the major parts preventing deficiencies of those mechanical units. These suggested systems will contribute a great deal of aids, the maintenance credibility and air safety for the air operations and all customers in the world. Avoiding the past troubleshooting from just by using simple systems which can forecast main causes of the units and parts of the crafts, this system will be able to provide excellent management tools for the promoting aviational industries. The comfortable and convenient air operations are very valuable works, and the scientific method and detail maintenance will improve our daily air life by minimizing accidents. Adapting these developing systems, for the forecasting aircraft deficiencies and accidents can be integrated with the other aircraft management systems to promote more air safety in the world. This study is focused to eliminating aircraft accidents through forecasting deficiency symptom procedures by relational coordinations among all of the systems. Futhermore we need continuously detailed analysis and study for eliminating air accidents all together those who work in those fields.

• The Journal of Engineering Geology
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• v.22 no.2
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• pp.185-194
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• 2012

The efficient maintenance and management of steep slopes often require excessive professional resources and quantitative investigations. Therefore, it is important to develop technology for objective scientific site investigations and quantitative evaluations of steep slopes. This study proposes a 'Mobile System' for steep slopes in order to improve the effectiveness of site investigations compared with conventional methods using anevaluati on table. By analyzing site investigations and desktop studies, the required software and hardware are identified to develop the 'Mobile System', consisting of a 'Field Information Input System' and an 'Analysis System'. The applicability of the system is verified by its application to an area with steep slopes affected by debris flows. The use of this system is expected to increase the efficiency of maintaining steep slope sand to reduce the time and resources required.

• Journal of the Korea Society for Simulation
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• v.22 no.1
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• pp.31-40
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• 2013

Recent development in science and technology has modernized the weapon systems of ROKN (Republic Of Korea Navy). Although the cost of purchasing, operating, and maintaining the cutting-edge weapon systems has been increased significantly, the national defense expenditure is under a tight budget constraint. In order to maintain the availability of ships with low cost, we need an efficient and scientific method for managing repairable parts. In this study, we propose a simulation model that computes the availability of ship's repairable parts. Our model is based on the METRIC (Multi Echelon Technique Repairable Item Control) model and extends to five sub-models to reflect the realistic situations that arise in the navy, such as planned maintenance, condemnation, lateral transshipment, and cannibalization. We have performed simulations to compute the availability of repairable parts while setting the part-level consistent throughout the five models and carried out two sensitivity analyses. The simulation results show the differences in the part availability in different models. The experiments confirm our claim that ROKN needs an inventory management system that captures the operational characteristics of the navy.

• Journal of the Korean Geophysical Society
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• v.4 no.1
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• pp.1-10
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• 2001

A number of tangible cultural properties have been left to suffering damage without any scientific conservation or maintenance. We conducted nondestructive geophysical explorations around the Western pagoda of the Iksan Mireuksa Temple for the purpose of preparing the counterplan of its conservation and maintenance and of utilizing the geophysical information for the design of repair. Geophysical image of the shallow subsurface around the construct resulting from electric resistivity, seismic refraction, and GPR methods carried out along 6 lines in the site was used to investigate the relationship between the foundation characteristics and the structural safety. Tilting of the pagoda southwest towards seems to result from the low resistivity zones found in the southwestern part. The GPR and seismic surveys revealed a boundary at depth of 3.3～3.5m dividing into two layers, compacted overlaid soil and the original ground. The boundary appears to dip southwest. The artificial layer as a foundation does not covers as much as the bottom area of the pagoda. This top soil dipping southwest seems to result in tilting of foundation southwestward towards. Our geophysical result suggests ground reinforcement in the western part of the survey area for the conservation of the construct.

• Journal of the Korea Society of Computer and Information
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• v.26 no.3
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• pp.89-97
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• 2021

The objective of this study is to propose an operation management strategy for the connectivity which are the designated and managed in sector of the transportation and logistics on the national critical infrastructures. The industrial structure is becoming advanced. The national critical infrastructure managed by the shows forms of the cooperative connection and collaborative R&D. Also, in-depth and specific analysis for the disaster safety budget are implemented to consideration for the R&D life cycle. The government responsibility are expanded comprehensively. Needs are exchanging life styles by the economic and safety demands. At this trends, this study encourage facility maintenance and scientific management to the public service. Throughout the result of this study, national critical infrastructure are implementing for protection plan of the sustainable maintenance and management. And, we have to prepare and implement for the consideration of the characteristics through comprehensive guidelines. This study contributes to the disaster and safety management by proposed an operation strategy of the cooperative connection in the sector of transportation and logistic sector on the national critical infrastructure.

• Journal of the Korea institute for structural maintenance and inspection
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• v.25 no.3
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• pp.21-30
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• 2021

Architectural cultural properties suffer a lot of damage due to various environmental factors. In order to preserve damaged cultural properties, preventive preservation and long-term preservation management are becoming more important. Therefore, research on a scientific non-destructive testing method applicable to regular inspection is required. For related research, DangGan with a high flag-pole shape was selected as the subject of study among various cultural properties. Among the preserved DangGans, a basic study was conducted on the analysis technique to evaluate the structural stability by selecting Treasure No. 49 Naju SeokDangGan. An idealized model was presented and a multi-degree of freedom equation of motion was derived. In addition, an equation for estimating the critical stiffness value for each joint position is presented.

• Journal of the Korea institute for structural maintenance and inspection
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• v.25 no.1
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• pp.103-111
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• 2021

Naju Seokdanggan, Treasure No. 49, was dismantled and reconstructed due to poor performance. During construction, the crack area was reinforced and the inclination was improved. It is necessary to analyze the stiffness changes before and after the reconstruction of these cultural properties, and to establish a database of related information. In addition, there is a need for research on a scientific non-destructive testing method capable of predicting or evaluating the reinforcing effect. In this study, a simple equation for estimating the overall stiffness of the structural system was derived from information on the elasticity coefficient and the natural frequency measured by vibration tests before and after reconstruction work, and the applicability of the equation was examined. If the stiffness of important cultural properties is regularly investigated by the suggested method, it is judged that it can be used as data to estimate the time when structural safety diagnosis is necessary or when repair or reinforcement is necessary.

• Journal of the Korean Society of Food Culture
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• v.5 no.3
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• pp.331-347
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• 1990

This study was designed under the purpose to analyze the Korean Traditional Folk Remedies on food, to submit the basic statistical data, and to utilize them by examining how much they know about the Korean Traditional Folk Remedies and also by examining how frequently they used them. The sample was consisted of 312 housewives living in Daegu, Kyungsan city and Kyungsan-eup, the survey was made by use of questionaires from July 15 to August 1 1989. The results are as follows 1. Analysis of Folk Remedical Contents 1) The method of the Folk Remedies used in this area was mainly food, which can be easily found around their house and easy to use, it was possible to apply scientific principles in some cases. 2) The major popular method was shown to feed boiled barley or brown rice which are known as the Folk Remedy for Diabetes. 3) The ANOVA of variable shows the significant influence on each object which age, religion, the level of education, job, monthly income, and the area except family formation. 2. The Frequency of Folk Remedies and additional analysis 1) The most frequently used Folk Remedy was Arterio-sclerosis(1.44), which is followed by the loss of Eyesight(1.40), Hang over(1.28), Couth(1.27), Cold(1.26) etc. 2) In the analysis of Pearson Correlation between frequencies of Folk Remedies used, and demographic variables such as age(p<.05), the monthly income(p<.01), in that area, total number of response items showed a positive correlation. 3. The source to learn about Folk Remedy. 1) It is acknoledged that they are mostly instructed by their forefathers, friends, neighbors, professional textbooks, mass communications, herb doctors, other medical sources or education at school etc. 2) The ANOVA of Variables shows the big differences between each group by age. Based on the above findings, the following suggestions are made ; Most of Korean Traditional Folk Remedies are recognized scientific and reasonable which are based on the scientific research and herb medicine therefore it should be made good use of for our life in good health additionally. I hereby insist that the importance of our Folk Remedies should be reviewed and focused for maintenance our health.

• Journal of Environmental Science International
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• v.22 no.11
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• pp.1421-1431
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• 2013

This study was conducted for clarifying distribution and characteristics of marshy Ericaceae plants on Mt. Changbai in China. The marshy Ericaceae plants in wetland of Mt. Changbai were investigated on about 1400 m altitude. This region is various developmental wetlands and vegetation mixture of needle-leaf trees and broad-leaf trees. This region also is start point of the coniferous forest zone in Mt. Changbai. As results of these researches, L. palustre var. diversipilosum and L. palustre var. decumbens populations were investigated in Larix olgensis var. amurensis community. R. lapponicum subsp. parvifolium var. parvifolium community appeared as a typical community. Environmental conditions of L. palustre var. diversipilosum and L. palustre var. decumbens populations' habitats are more soil humidity and shade condition. R. lapponicum subsp. parvifolium var. parvifolium community habitat, however, has more deposits and humidity condition. Therefore when the plants were cultivated, we should recognize the growth condition such as maintenance of humidity and control deposits. The flora of marshy Ericaceae species habitats was investigated as 28 families, 49 genera, 45 species, 14 variety, 1 forma, 1 sub-species, and total 61 taxa.