• Title/Summary/Keyword: 보완 해석

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The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 - (의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 -)

  • Park, Jeehye
    • The Korean Society of Law and Medicine
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    • v.21 no.1
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    • pp.223-259
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    • 2020
  • With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

Modelling of Fault Deformation Induced by Fluid Injection using Hydro-Mechanical Coupled 3D Particle Flow Code: DECOVALEX-2019 Task B (수리역학적연계 3차원 입자유동코드를 사용한 유체주입에 의한 단층변형 모델링: DECOVALEX-2019 Task B)

  • Yoon, Jeoung Seok;Zhou, Jian
    • Tunnel and Underground Space
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    • v.30 no.4
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    • pp.320-334
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    • 2020
  • This study presents an application of hydro-mechanical coupled Particle Flow Code 3D (PFC3D) to simulation of fluid injection induced fault slip experiment conducted in Mont Terri Switzerland as a part of a task in an international research project DECOVALEX-2019. We also aimed as identifying the current limitations of the modelling method and issues for further development. A fluid flow algorithm was developed and implemented in a 3D pore-pipe network model in a 3D bonded particle assembly using PFC3D v5, and was applied to Mont Terri Step 2 minor fault activation experiment. The simulated results showed that the injected fluid migrates through the permeable fault zone and induces fault deformation, demonstrating a full hydro-mechanical coupled behavior. The simulated results were, however, partially matching with the field measurement. The simulated pressure build-up at the monitoring location showed linear and progressive increase, whereas the field measurement showed an abrupt increase associated with the fault slip We conclude that such difference between the modelling and the field test is due to the structure of the fault in the model which was represented as a combination of damage zone and core fractures. The modelled fault is likely larger in size than the real fault in Mont Terri site. Therefore, the modelled fault allows several path ways of fluid flow from the injection location to the pressure monitoring location, leading to smooth pressure build-up at the monitoring location while the injection pressure increases, and an early start of pressure decay even before the injection pressure reaches the maximum. We also conclude that the clay filling in the real fault could have acted as a fluid barrier which may have resulted in formation of fluid over-pressurization locally in the fault. Unlike the pressure result, the simulated fault deformations were matching with the field measurements. A better way of modelling a heterogeneous clay-filled fault structure with a narrow zone should be studied further to improve the applicability of the modelling method to fluid injection induced fault activation.

Development of Indicators to Assess the Quality of Ubiquitous-Ecological Cities (유비쿼터스 에코시티 평가지표 개발 및 적용 연구)

  • Kim, Han-Saem;Jeong, Yeun-Woo
    • Land and Housing Review
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    • v.2 no.2
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    • pp.111-123
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    • 2011
  • A Ubiquitous-Ecological City (U-Eco City) is the new urban paradigm integrated with ubiquitous-city (U-City) connecting the high-tech IT technology to the urvan space with the concept of the sustainable eco-city. As a U-Eco City is attempted for the first time domestically and internationally, there is insufficient discussions for its develoment goal, planned design proposal, technology and service element and others. Even if there are plans to build up it, policy and technology, service structuring business and others, it is difficult to assess how it would bring the efficacy. Therefore, the purpose of this study is to present the indicators system to assess a U-Eco City. The results of this study revealed the following; First, the conceptual framework, which was established to achieve sustainable urban quality, can be suggested by establishing its notion of the U-Eco City. The concept of a U-Eco City as established in this study suggests that the economic development in growth-oriented level has to be conducted not only quality of urban environment but also in terms of sustainable to consider the complex impact of various development; Secondly, the developed assessment system has heightened the completeness as the evaluation index through the attitude survey. As a result of questionnaire survey with the subject of specialists and interested party of this study, the urban qualitative aspect is formulated for the stability as a relatively important aspect. For the urban continuity aspect, society, environment and economy have all similar importance, but the environment element was shown to be highest. And finally, subject area was selected on the basis of the evaluation system and the analysis was made on the basis of the implementation design plan of the area. As a result of the assessment, safety and economy have shown to be high. This is indirectly indicated for the priority in economic growth driven development plan unlike the importance of environmental continuity obtained through the attitude survey. When planning on urban development, there is a need for supplementing the environment part and it has to present the connection plan between the economic growth and environmental continuity.

The study of Taoistic Returnism in Jeong Wan-Young's sijo (정완영 시조에 나타난 도가적 회귀주의)

  • Min, Byeong-Kwan
    • Sijohaknonchong
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    • v.30
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    • pp.109-146
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    • 2009
  • It is academically recognized that Jeong Wan-Young's sijo better represent Oriental ideas. The purpose of this study is to investigate Taoistic characteristics of Jeong Wan-Young's sijo. This is an effort to succeed and further deepen and extend previous relevant researches. For the purpose, this researcher categorized the poet's sijo in accordance with such characteristics as above mentioned. Findings of the study can be summarized as below. Pieces of Jeong Wan-Young's sijo which are based on Taoistic ideas are largely classified into three groups. First, some pieces of Jeong Wan-Young's sijo represents an orientation of return to hometown which is brought by the sense of loss. His sense of loss is attributed to the facts that his home is not what it was any longer and that he can't return to the old home. To overcome the sense, nevertheless, the poet is dreaming of return to home. The home found in Jeong Wan Young's sijo is something fundamental and original that he purposedly provided against the feeling of loss. It complies with the concept of 'Bokgwigigen(復歸基根)‘ a pursuit of Taoism. Second, other pieces of Jeong Wan-Young's sijo are seeking purity to retrieve childish innocence. Their subjects include the season of spring, dreams of childhood and longing for mother all of which represent the poet's strong desire for such retrieval as above mentioned. It may be said that pursued by that pieces are 'Purity, Feebleness and Smoothness' that are sought by Taoism. Third, other pieces of Jeong Wan-Young's sijo are considering human as a part of nature and seeking human life in harmony with nature. In other words, they are seeking union between human and nature which means going beyond discrimination between self and external objects, that is, 'Mulayangmang(物我兩忘)'. This may refer to return to nature which is the ultimate destination of Taoism.

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A Study on the Coexistance of Ganghak(講學) and Yusik(遊息) space of Oksan Confucian Academy, Gyeongju: Directed Attention Restoration Theory Perspectives (주의집중 피로회복이론의 장으로 본 경주 옥산서원 강학 및 유식공간의 일원적 공간성)

  • Tak, Young-Ran;Sung, Jeong-Sang;Choi, Jong-Hee;Kim, Soon-Ae;Rho, Jae-Hyun
    • Journal of the Korean Institute of Traditional Landscape Architecture
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    • v.34 no.3
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    • pp.50-66
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    • 2016
  • This study attempts to understand and explain how "Directed Attention Restorative Environment (DARE)" is managed and fostered in "Gang-Hak (講學)" and "Yu-Sik (遊息)" spaces both inside and outside of Oksan Seowon Confucian Academy, Gyeongju. Directed Attention is a pivotal element in human information processing so that its restoration is crucial for effective thinking and learning. According to Kaplan & Kaplan's Attention Restoration Theory, an environment, in order to be restorative, should have four elements: 'Being Away,' 'Extent,' 'Fascination,' and 'Compatibility.' We could confirm OkSan Seowon Confucian Academy has an inner logic that integrates two basically different spacial concepts of "Jangsu" and "Yusik" and thus fosters the Attention Restorative Environment. Particularly, the Four Mountains and Five Platforms (四山五臺) surrounding the premises provides an excellent learning environment, and is in itself educational in terms of the Neo-Confucian epistemology with "Attaining Knowledge by way of Positioning Things (格物致知)" as its principle precept, and of its aesthetics with "Connectedness with Nature" as its central tenet. This study attempts to recapture the value of Korea's cultural heritage concerning the Human/Nature relationship; and it may provide useful insights and practical guidelines/grounds in designing today's schools and campuses, where the young people's needs for the Directed Attention- and Attention Restorative- Servicescapes seem to be greater than ever.

A Study on the Cubism - In it's relation to Bergsonian Philosophy and Simultaneity - (큐비즘에 관한 연구 - 베르그송 철학과 동시성 개념을 중심으로 -)

  • Ryu, Ji-Seok;Oh, Chan-Ohk
    • Archives of design research
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    • v.18 no.3 s.61
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    • pp.117-128
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    • 2005
  • The French Belle Epoque is a period where the literary and artistic movement was very activated. The birth of the cubism reflects this atmosphere of the times and the change of paradigm in all fields. The Bergsonism is often designated as one of the important backgrounds of cubism. The problem consists in knowing if Bergsonian ideas gave real influence on the cubist movement and up to what point. Our analysis will show that it is not homogenous and very variable according to painters. In the case of Picasso and Braques it seems be a simple inspiration of Zeitgeist. But the influence upon Metzinger and Gleizes is explicit. The text of 1912, Du cubism, prove their attachment to his thought. The key concept of cubist theory, influenced by Bergsonian philosophy, is the concept of simultaneity. Cubist simultaneity is in one hand a reflection of an artist's psychological experience and the other hand a synthesis of multiple views for grasping the object in itself by the way of conceptual representation. The temporal simultaneity could be identified with the notion of memory, which is a temporal continuity connecting the past to dynamic present. The spatial simultaneity is a juxtaposition of multiple views obtained by the movement around the object. But the dose reading of Bergson's text shows that there is a divergence between the notion of cubist simultaneity and his ideas. The biased interpretation is often, as well as the strict understanding, like the history shows us well, a great source of inspiration and creativity. The cubist mouvement is not far from this case.

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A Comparative Study of Diverging Citation Patterns in the Disciplines of Physics and Sociology in Korea Differential Preferences according to Employment Status and Ph. D. Diploma Area (한국의 물리학과 사회학의 인용패턴 비교연구 - 전임 여부와 박사학위 취득지역을 중심으로)

  • Kang Min-Gu
    • Journal of Science and Technology Studies
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    • v.4 no.2 s.8
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    • pp.67-101
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    • 2004
  • Although the study of citation patterns is an important theme within the sociology of science, due to the fact that it is intimately related to the production, reproduction, and evaluation of knowledge, only sustained theoretical research outlining the differences of citation patterns between the hard and soft sciences has been conducted, and empirical studies nevertheless remain few and far between. The perspectives of institutionalism and constructivism have to attempted to explain different citation patterns between the hard and soft sciences as a contrast between 'what one says' and 'who one is'. Therefore, against this background this study examines the 'theoretical' controversy empirically by comparing the contrasting citation patterns of physics, as a representative of hard science, and sociology, as a representative of soft science. The results, in brief, are as follows: the citaton patterns in physics, as in sociology, vary according to the author's status within the hierarchical employment structure, i. e. whether s/he is a full-time lecturer or not, but diversity of citation patterns according to Ph. D. diploma area is unique to sociology. These results would suggest that the explanation of constructivism is more relevant in explaining variance according to the author's status in the employment hierarchy, but the approach of institutionalism is more appropriate to understanding variance due to Ph. D. diploma area. Furthermore, this implies the complex diversity of the citation patterns between the hard and soft sciences, pointing us to the more qualified conclusion that rather than having to choose between institutionalism and constructivism according to a mutually exclusive either/or logic, these two approaches can in fact be mutually complementary, and these approaches should also be applied piecemeal to different levels of phenomena. In conclusion, this comparative research enables us to assert the following two claims: firstly that physics, as a 'science in society', produces knowledge dependent on social context, and secondly that it also possesses a characteristic that transcends locality from the view of a sociology of knowledge.

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A Case Study of 2-year-old Infants' Attachment Security to a Child Care Teacher and Peer Play Process (보육교사에 대한 만 2세 영아의 애착 안정성과 또래놀이 과정에 관한 사례연구)

  • Shin, Dong Ju;Kim, So Young
    • Korean Journal of Child Education & Care
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    • v.18 no.4
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    • pp.1-25
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    • 2018
  • Purpose: The purpose of this study was to explore about 2-year-old infants' attachment security to a child care teacher and peer play process through a case study. For this purpose, the attachment security was assessed with attachment Q-set to 2-year-old five infants at a day care center in Seoul. Participants of this study are four infants included two infants attached securely to their child care teacher and two infants attached insecurely to their child care teacher. Methods: Participant observation was conducted from April 12 to July 19 in 2018 through 36 observations in free play activities. The Data collected from the transcriptions of video shoots and teachers' interviews, child care plans, and reflexive journal was analyzed and interpreted. Results: The main results of the research were as follows: The beginning of peer play, when infants invited their peers to play, secure attachment infants selected suitable play partners and asked for a specific play behaviors. However, insecure attachment infants invited unsuitable play partners and asked uncertainly play actions to peers. In addition, when infants entered in-progress play, secure attachment infants understood the context of play but insecure attachment infants did not understand the context of play. In the progress of peer play, secure attachment infants cooperated with peers, shared play objects, but insecure attachment infants did not cooperate complementally with peers and express only their opinions. As well, insecure attachment infants could not play harmoniously without child care teacher's interventions. In the end of the peer play, secure attachment infants finished in collaboration with peers but insecure attachment infants failed to finish with the peers and was turned into play with the child care teacher because of peer conflict. Conclusion/Implications: This study has implications for basic resources to think about the role of child care teachers by helping them understand about the relation 2-year-old infants' attachment security to them and peer play process.

A study on the essence of Ye and its usualness - With focus on Shirak's feature of Yulkok's Yegyo (예(禮)의 본질(本質)과 일상성(日常性) - 율곡(栗谷) 예교(禮敎)의 실학적(實學的) 성격(性格)과 일상성(日常性)을 중심으로 -)

  • Lee, Haeng-hoon
    • (The)Study of the Eastern Classic
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    • no.35
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    • pp.161-188
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    • 2009
  • Confucianism's concept of Ye is ruled by the absolute principle of the universe on one hand, and by "the rules of Ye(節文)" and "the rules of ceremony(儀則)", the principle of relative articulation on the other hand. The realizations of the absolute principle of Ye is depending on its usage in everyday life which is fundamentally conditioned by time and space. Thus, Ye's usage can be maximized when the fundamental principle and the condition of its usage make a mutual harmony. Of course, Ye and Ak(樂) are doing complementary roles for each other, since Ye is a principle of a division and Ak is a principle of combining features. However, the essence of Ye can be figured out as the characteristics of mutual reciprocity among things of hierarchy between the classes. Not only in Modern one But also in the medieval society, Ye was not a one-sided force. The essence of Ye does not retain the interests of an individual and the power of a group. If so, the formal aspects of Ye had been distorted. Confucianism demands a strict morality and ethics of a normal person as well as of the ruler. The characteristics of Ye is democratic and open to the condition of time and space. Yegyo should be rooted in everyday lives and realized as a usualness. Therefore, Shirak was an inevitable feature of Yegyo. During the 16th and the 17th century, Ye insinuated into everyday lives of the public in the Korean society. Yulgok Yiyi(李珥)'s Haejuhyangyak(海州鄕約) was estimated as the exemplary feature of Shirak.

Retrieval of Vegetation Health Index for the Korean Peninsula Using GK2A AMI (GK2A AMI를 이용한 한반도 식생건강지수 산출)

  • Lee, Soo-Jin;Cho, Jaeil;Ryu, Jae-Hyun;Kim, Nari;Kim, Kwangjin;Sohn, Eunha;Park, Ki-Hong;Jang, Jae-Cheol;Lee, Yangwon
    • Korean Journal of Remote Sensing
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    • v.38 no.2
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    • pp.179-188
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    • 2022
  • Global warming causes climate change and increases extreme weather events worldwide, and the occurrence of heatwaves and droughts is also increasing in Korea. For the monitoring of extreme weather, various satellite data such as LST (Land Surface Temperature), TCI (Temperature Condition Index), NDVI (Normalized Difference Vegetation Index), VCI (Vegetation Condition Index), and VHI (Vegetation Health Index) have been used. VHI, the combination of TCI and VCI, represents the vegetation stress affected by meteorological factors like precipitation and temperature and is frequently used to assess droughts under climate change. TCI and VCI require historical reference values for the LST and NDVI for each date and location. So, it is complicated to produce the VHI from the recent satellite GK2A (Geostationary Korea Multi-Purpose Satellite-2A). This study examined the retrieval of VHI using GK2A AMI (Advanced Meteorological Imager) by referencing the historical data from VIIRS (Visible Infrared Imaging Radiometer Suite) NDVI and LST as a proxy data. We found a close relationship between GK2A and VIIRS data needed for the retrieval of VHI. We produced the TCI, VCI, and VHI for GK2A during 2020-2021 at intervals of 8 days and carried out the interpretations of recent extreme weather events in Korea. GK2A VHI could express the changes in vegetation stress in 2020 due to various extreme weather events such as heatwaves (in March and June) and low temperatures (in April and July), and heavy rainfall (in August), while NOAA (National Oceanic and Atmospheric Administration) VHI could not well represent such characteristics. The GK2A VHI presented in this study can be utilized to monitor the vegetation stress due to heatwaves and droughts if the historical reference values of LST and NDVI can be adjusted in a more statistically significant way in the future work.