• Translational and Clinical Pharmacology
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• v.26 no.4
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• pp.155-159
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• 2018

For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

• Molecules and Cells
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• v.43 no.4
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• pp.331-339
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• 2020

Genetic modifications in noncoding regulatory regions are likely critical to human evolution. Human-accelerated noncoding elements are highly conserved noncoding regions among vertebrates but have large differences across humans, which implies human-specific regulatory potential. In this study, we found that human-accelerated noncoding elements were frequently coupled with DNase I hypersensitive sites (DHSs), together with monomethylated and trimethylated histone H3 lysine 4, which are active regulatory markers. This coupling was particularly pronounced in fetal brains relative to adult brains, non-brain fetal tissues, and embryonic stem cells. However, fetal brain DHSs were also specifically enriched in deeply conserved sequences, implying coexistence of universal maintenance and human-specific fitness in human brain development. We assessed whether this coexisting pattern was a general one by quantitatively measuring evolutionary rates of DHSs. As a result, fetal brain DHSs showed a mixed but distinct signature of regional conservation and outlier point acceleration as compared to other DHSs. This finding suggests that brain developmental sequences are selectively constrained in general, whereas specific nucleotides are under positive selection or constraint relaxation simultaneously. Hence, we hypothesize that human- or primate-specific changes to universally conserved regulatory codes of brain development may drive the accelerated, and most likely adaptive, evolution of the regulatory network of the human brain.

• Journal of the Korean Society of Systems Engineering
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• v.14 no.1
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• pp.63-71
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• 2018

This paper discusses decommissioning procedure requirements management using requirement engineering to systematically manage the technical requirements and criteria that are required in decontamination and decommissioning activities, and the regulatory requirements that should be complied with in a decommissioning strategy for research reactors and nuclear power plants. A schema was designed to establish the traceability and change management related to the linkage between the regulatory requirements and technical criteria after classifying the procedures into four groups during the full life-cycle of the decommissioning. The results confirmed that the designed schema was successfully traced in accordance with the regulatory requirements and technical criteria required by various fields in terms of decontamination and decommissioning activities. In addition, the changes before and after the revision of the Nuclear Safety Act were also determined. The dismantling procedure requirement management system secured through this study is expected to be a useful tool in the integrated management of radioactive waste, as well as in the dismantling of research reactor and nuclear facilities.

• Journal of Legislation Research
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• no.44
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• pp.155-184
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• 2013

This study takes a critical perspective that current vertical regulatory framework for broadcasting, telecommunications, films and games cannot cope with media development in the age of convergence. Changes in media environment mitigate the uniqueness of terrestrial television causing doubts as to why television contents should be treated more strictly than the rest of media contents. Consensus is being reached that horizontal regulation would be the appropriate regulatory measure for media contents. However, which content should be aligned to what level of regulations have not been fully dealt with. The paper shows that the current regulatory framework which is established according to each delivery platform is no longer valid in convergent media environment. It shows why all content regulation should be applied in platform neutral manner. Then it also suggests both short and long term regulatory changes that need to be made in order to meet the future challenges in media convergence era.

• Korean Journal of Adult Nursing
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• v.25 no.4
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• pp.409-421
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• 2013

Purpose: This qualitative study was designed to explore and describe the nursing staff reported experiences of managing the medical needs of nursing home residents in South Korea. Methods: Using a focus group interview method, qualitative data were collected from March to May 2012. Twenty five registered nurses and nurse aids working in nursing homes were recruited through a convenient sampling method. Participants participated in one of four focus group interviews lasted up to two hours in which their day-to-day experiences of taking care of the medical needs of the elderly residents. All interviews were recorded and transcribed in verbatim, and analyzed according to the qualitative thematic analysis method using MAXQDA software. Results: The overriding theme was 'experiencing differences between the requirements of the regulatory system and the actual reality of the work place.' The findings of differences between what were true and what is required was based in four subcategories. The nursing home residents had far more medical needs than what were reported. Another finding was that the family members were seen as non-supportive and negligent towards the residents. Conclusion: The findings of the study support the need for changes in the regulatory system. The regulatory limitations of current system with a shortage of resources pushed the participants to experience discrepancies between the required regulation and the reality. Additional research could contribute more exemplars to support changes.

• Journal of Microbiology and Biotechnology
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• v.15 no.1
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• pp.175-182
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• 2005

Abstract Salmonella pathogenicity island 1 (SPI1) gene expression is regulated by many environmental signals such as oxygen, osmolarity, and pH. Here, we examined changes in the expression level of various regulatory proteins encoded within SPI1 in response to three different concentrations of NaCl, using primer extension analysis. Transcription of all the regulatory genes tested was activated most when Salmonella were grown in Luria Broth (LB) containing 0.17 M NaCl. The expression of hilA, invF, and hilD was decreased in the presence of 0.47 M NaCl or in the absence of NaCl, while hilC expression was almost constant regardless of the NaCl concentration when Salmonella were grown to exponential phase under low-oxygen condition. The reduced expression of hilA, invF, and hilD resulted in lower invasion of hilC mutant to the cultured animal cells when the mutant was grown in the presence of 0.47 M NaCl or in the absence of NaCl prior to infection. Among the proteins secreted via the SPI1-type III secretion system (TTSS), the level of sopE2 expression was not influenced by medium osmolarity. Various effects of osmolarity on virulence gene regulation observed in this study is one example of multiple regulatory pathways used by Salmonella to cause infection.

• Journal of Korean Physical Therapy Science
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• v.26 no.2
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• pp.1-12
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• 2019

Purpose: The purpose of this study is to find out changes in skin temperature, which is one of the regulatory systems of homeostasis, according to the isotonic-isometric exercise type, and changes in skin temperature according to gender and BMI index through isotonic-isometric exercise. Design: Randomized Controlled Trial. Methods: This study was conducted for 28 healthy male and female students from Department of Physical Therapy, G University. Subjects carried out isometric-isotonic exercise using dumbbells of 4kg and 8kg, respectively. And skin temperature was measured by using a computer infrared thermography. Results: The isometric exercise group was significantly difference changes in temperature by measurement time. Conclusion: In order to find out the effect of isometric exercise and isotonic exercise on skin temperature changes of biceps brachii, this study was carried out for 28 healthy male and female adults. The result of this study may helpful as basic data for orthopedic physical therapy.

• Journal of Physiology & Pathology in Korean Medicine
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• v.18 no.4
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• pp.1147-1152
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• 2004

To investigate the anti-cancer effects of aqueous extract of Cheonkumwikyung-tang (CKWKT) on the growth of human lung carcinoma cell line A549, we performed various biochemical experiments such as the effects of CKWKT on the cell proliferation and viability, the morphological changes, the effects on expression of apoptosis and cell growth-regulatory gene products. Results obtained are as follow; CKWKT treatment declined the cell viability and proliferation of A549 cells in a concentration-dependent manner. The anti-proliferative effect by CKWKT treatment in A549 cells was associated with morphological changes such as membrane shrinking and cell rounding up. CKWKT treatment induced apoptotic cell death of A549 cells in a concentration-dependent manner, which was associated with inhibition and/or degradation of apoptotic target proteins such poly(ADP-ribose) polymerase, β-catenin and phospholipase C-γ1. Western blot analysis revealed that the levels cyclin-dependent kinase inhibitor p21 expression were induced by CKWKT treatment in A549 cells. Taken together, these findings suggest that CKWKT-induced inhibition of human lung cancer cell proliferation is associated with the induction of apoptotic cell death via regulation of several major growth regulatory gene products and CKWKT may have therapeutic potential in human lung cancer.

• Journal of Physiology & Pathology in Korean Medicine
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• v.18 no.4
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• pp.1102-1106
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• 2004

To investigate the anti-proliferative effects of an aqueous extract of Cordyceps militaris (AECM) on the growth of human lung carcinoma cell line A549, we performed various biochemical experiments such as the effects of AECM on the cell proliferation and viability, the morphological changes, the effects on expression of apoptosis and cell growth-regulatory gene products. Results obtained are as follow; AECM treatment declined the cell viability and proliferation of A549 cells in a concentration-dependent manner. The anti-proliferative effect by AECM treatment in A549 cells was associated with morphological changes such as membrane shrinking and cell rounding up. Taken together, these findings suggest that AECM-induced inhibition of human lung cancer cell proliferation is associated with the induction of apoptotic cell death via regulation of several major growth regulatory gene products, and C. militaris may have therapeutic potential in human lung cancer.

• Research in Plant Disease
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• v.24 no.2
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• pp.162-169
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• 2018

The GacS/GacA system in the root colonizer Pseudomonas chlororaphis O6 is a key regulatory system of many traits relevant to the plant probiotic nature of this bacterium. The work in this paper elucidates proteins using proteomics approach in P. chlororaphis O6 under the control of the cytoplasmic regulatory protein, GacA. A gacA mutant of P. chlororaphis O6 showed loss in production of phenazines, acyl homoserine lactones, hydrogen cyanide, and protease, changes that were associated with reduced in vitro antifungal activity against plant fungal pathogens. Production of iron-chelating siderophore was significantly enhanced in the gacA mutant, also paralleling changes in a gacS mutant. However, proteomic analysis revealed proteins (13 downregulated and 7 upregulated proteins in the mutant compared to parental strain) under GacA control that were not apparent by a proteomic study of a gacS mutant. The putative identity of the downregulated proteins suggested that a gacA mutant would have altered transport potentials. Notable would be a predicted loss of type-VI secretion and PEP-dependent transport. Study of mutants of these GacA-regulated proteins will indicate further the features required for probiotic potential in this rhizobacterium.