• Journal of Pharmaceutical Investigation
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• 제36권6호
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• pp.421-435
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• 2006

The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation(EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply. In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause my public health concerns. In fact, the post-authorisation guidance categorizes post-approval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-frame. The thrust of the EU's post-authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.

• International Journal of Oral Biology
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• 제44권4호
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• pp.182-190
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• 2019

Periodontitis is an inflammatory disease of the supportive tissues surrounding the teeth, and is characterized by irreversible destruction of the gingiva, periodontal ligament (PDL), and alveolar bone, which results in the loss of teeth. In the present study, we elucidated the correlation between periodontitis and apelin (APLN), an adipokine and a regulatory peptide, respectively, which are involved in inflammation and bone remodeling. The expression of APLN is negatively correlated with periodontitis progression in gingival tissue. In addition, treatment with TNF-α downregulated the expression of APLN in PDL cells and gingival fibroblasts, indicating the protective role played by APLN against periodontitis progression. The overexpression of APLN or treatment with exogenous APLN suppressed the TNF-α-mediated catabolic gene expression of MMP1, IL6, and PTGS2 in PDL cells. Moreover, the inhibition of the APLNA-PJ axis by ML221, an APJ inhibitor, induced catabolic gene expression in PDL cells. Thus, the results of this study provided evidence to support APLN as a regulatory factor of the inflammatory response during periodontitis.

• 해양환경안전학회지
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• 제5권1호
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• pp.59-78
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• 1999

Although recently vigorous studies on environmental crime have contribute criminal respects to be advanced in our country, most of them are focused on German discussions about the theory of environmental crime or environmental criminal law. As each countries in criminal legislation for environmental protection have some distinctive characteristics not found in others, the study which is more helpful to regulate environmental crime can be extend to other country in the view of comparative law. Thus this Article overviews especially the environmental criminal enforcement program involving civil and administrative enforcement in the United States. Notwithstanding that enforcement is an evolving phenomenon that only recently appeared on the scene, there is widespread public support for it. Once viewed as mere economic or regulatory offence lacking an element of moral delict, environmental crimes now provoke moral outrage and prompt demands for severe sanction and strict enforcement. Many major provisions of modem environmental acts that imposed criminal liability have been added or significantly restructured during the last decade. Notable among them are the imposition of the felony penalties for federal environmental crimes and the enactment of the endangerment crime in federal environmental law. This Article approaches the characteristics of environmental criminal enforcement form introducing major federal environmental acts. It develops the result that, considering the difference that exist between Korea and United States in environmental criminal law, our proper environmental regulatory framework can be constituted.

• 한국소음진동공학회:학술대회논문집
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• 한국소음진동공학회 2014년도 추계학술대회 논문집
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• pp.99-101
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• 2014

A Comprehensive Vibration Assessment Program (CVAP) for steam generator internals (SGI) of Advanced Power Reactor 1400 (APR1400) is being performed in accordance with the United States Nuclear Regulatory Commission (U.S. NRC) Regulatory Guide 1.20 (RG 1.20) revision 3. This paper studies the vibration characteristics of moisture separator assembly as part of the vibration and stress analysis program for APR1400 SGI CVAP. The natural frequencies, mode shapes, and structural behavior of moisture separator assembly were investigated through modal analysis using finite element method and experimental measurement. Since the moisture separator consists of several items with complicated shape, an idealized shell model was used in the finite element analysis. Group of local modes caused by moisture separators and significant modes of shroud and separator support plate were identified. The results of this paper are to be utilized in the structural response analysis of moisture separator assembly.

• 수산경영론집
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• 제35권1호
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• pp.87-115
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• 2004

During the last decade the co - management concept has gained increasing acceptance as a potential way forward to improve fisheries management performance. It has, however, at the same time become increasingly evident that the co - management concept is not clearly defined and means very different things to different people. In this article, we attempt to development of self regulatory management model of coastal fisheries in Korea, and to present a more comprehensive understanding of fisheries co - management and community - based fisheries management and to summarise the experiences with both the positive outcomes and the problems in actual implementation. The Korean style of fisheries co - management system such as a fisheries self - governance ＆ self - management system has been become a way to activate social processes and involve fishers in Korea coastal fisheries management. As results of this study, the policy recommendation to improve the effectiveness of implementation of this system are summarized. For the effective implementation of this system, some of the supplementary developments are needed as fellows. \circled1 establishment of communities on regional basis. \circled2 establishment of communities consist of coastal fishermen. \circled3 establishment of boundary in coastal fishery. \circled4 reinforcement of government indirect support systems

• Genomics & Informatics
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• 제17권1호
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• pp.9.1-9.5
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• 2019

In previous studies, we demonstrated that some sites in the first intron likely regulate gene expression. In the present work, we sought to further confirm the functional relevance of first intron sites by estimating the quantity of rare alleles in the first intron. A basic hypothesis posited herein is that genomic regions carrying more functionally important sites will have a higher proportion of rare alleles. We estimated the proportions of rare single nucleotide polymorphisms with a minor allele frequency < 0.01 located in several histone marks in the first introns of various genes, and compared them with those in other introns and those in 2-kb upstream regions. As expected, rare alleles were found to be significantly enriched in most of the regulatory sites located in the first introns. Meanwhile, transcription factor binding sites were significantly more enriched in the 2-kb upstream regions (i.e., the regions of putative promoters of genes) than in the first introns. These results strongly support our proposal that the first intron sites of genes may have important regulatory functions in gene expression independent of promoters.

• Nuclear Engineering and Technology
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• 제53권5호
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• pp.1705-1716
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• 2021

Bangladesh, as a newcomer country, is expecting to start her nuclear power journey by 2022. Due to evident reasons, newcomer nuclear countries face several key challenges concerning the development of national nuclear safety infrastructure. The paper investigates the status of the 7 key safety infrastructure issues out of the 19 and readiness of the supportive organizations, laboratories, and workforces following the International Atomic energy Agency's status evaluation guide at milestone 3 and foreign countries' practice. Much progress has been achieved at phase 3 regarding the establishments of a few Acts, a regulator, and an operator. However, comprehensive regulatory frameworks, skilled workforces, establishments of a few supportive organizations, and laboratories for managing environmental radioactivity, radiological accidents, and radioactive wastes are yet to ready. Several suggestions are made for establishing and expediting radiation monitoring laboratories, a radiological emergency management center, a radioactive waste management company, and technical support organizations for the safety infrastructure. To avoid perceived risks, policymakers and competent authorities need to emphasize creating an optimized safety infrastructure before commissioning and operating the 1^st nuclear power plant safely, securely, and cost-sustainably.

• 근관절건강학회지
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• 제28권3호
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• pp.293-304
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• 2021

Purpose: The purpose of this study is to describe the experience of medical treatment and management of nursing staffs in long term care settings. Methods: This study is qualitative research. The participants were seven nursing staff (five nurses and two nursing assistants) who had experience over six months in long term care facilities. Data were collected through in-depth interviews using semi-structured research questions. The collected data were analysed using qualitative thematic analysis method. Results: Four main themes were emerged as 'various medical treatments', 'difficulties about managing medical problems', 'lack of regulatory support' and 'strategies for solving medical problems'. Conclusion: The findings of this study provide the nursing staffs' difficulties and opinion about medical treatment and management in long term care settings. To provide more effective health service for the aged, the regulatory complement about medical treatment in long term care facilities should be considered.

• 한국축산식품학회지
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• 제43권6호
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• pp.1002-1016
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• 2023

This study aimed to develop appropriate temperature management practices and provide scientific evidence to support the development of sell-by-date guidance for eggs. Washed and unwashed eggs were subjected to storage under six different scenarios, and both types of eggs were stored at temperatures up to 35℃ to evaluate the sell-by-date. Despite temperature fluctuations or continuous storage at 30℃ for 5 days, subsequent storage at 10℃ resulted in significantly higher Haugh unit and yolk index on day 15. These results indicate that refrigerating eggs from retail sales until consumption is effective for egg quality management, despite the exposure of up to 35℃ during distribution. In terms of sell-by-date evaluation, washed eggs retained class B quality for an additional 37 days beyond the recommended sell-by-date at 15℃, which is above the regulated storage temperature. However, unwashed eggs maintained class B quality for approximately 20 days at 30℃-35℃, emphasizing the need for sell-by-date guidelines for unwashed eggs. This study is the first to provide appropriate egg-handling practices based on the actual distribution environment in Korea.

• 기술혁신연구
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• 제31권2호
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• pp.333-369
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• 2023

본 논문에서는 정부 기업지원 사업이 기업성장에 미치는 영향을 분석하였으며, 정부지원 활동에 성장단계를 조절 변수로 활용하여 기업의 재무적 성과 또는 비재무적 성과에 미치는 영향을 실증분석하였다. 그 결과 정부 기업 지원은 재무적 성과, 비재무적 성과, 정부지원 활용에 유의적 영향을 미쳤으며, 성장단계의 조절 효과의 경우 재무적 성과 및 비재무적 성과 모두에 정(+)의 영향을 미치는 것으로 분석 되었다. 연구결과를 종합하면, 정부 기업지원은 기업의 성과에 긍정적 영향을 미치며, 성장단계는 재무적 성과 및 비재무적 성과 모두에 정(+)의 효과가 있으며, 재무적 성과에 미치는 영향이 더욱 큰 것으로 나타났다. 이에 각 기업의 성장단계에 맞추어 정부 지원사업을 지원하여야 하며, 그중 쇠퇴기에 기업은 산업분야 및 기업분석을 통하여 기업의 상태에 맞추어 지원하는 맞춤형 지원을 수행할 필요가 있으며 정부 기업지원 사업의 효율성을 개선하는데 의미가 있을 것으로 기대된다.