• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• Journal of Korean Home Economics Education Association
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• v.33 no.1
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• pp.129-149
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• 2021

The purposes of this study were to examine the current status of the establishment of home economics-related departments in colleges and universities and the changes required in the home economics curriculum of secondary schools, and to structure the elective courses of home economics subject(group) that can be organized in the next high school curriculum. To achieve these purposes, related literature and data were analyzed, and a questionnaire survey and FGI were conducted by home economics experts. The research results are as follows. First, home economics was considered to be highly related not only to the human ecology but also to social sciences, education, engineering, and arts and physical education. The numbers of technical colleges and 4-year universities with departments related to home economics were 1,405 and 961 respectively in 2019. Therefore, it was confirmed that there is a sufficient basis for opening home economics subject(group) elective courses in high school. Second, in the secondary school home economics curriculum, the concepts of culture, relations, independence, and sustainability were emphasized based on the changing life patterns and values. It was proposed that the contents of the home economics course would be structured in a way that allows deep and high-level thinking and helps students to enjoy culture. This demand can be implemented by diversifying, specializing, and structuring the elective courses of the home economics subject(group). Third, a total of 18 elective subjects and subject outlines were structured in the fields of child/family, food/nutrition, clothing, housing, consumption/family management, and home economics integration. This study results will contribute to the establishment of the high school credit system by providing basic information for organizing the next home economics curriculum, and expanding the options for home economics subject(group) to high school students.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.209-244
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• 2020

TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

• Journal of Life Science
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• v.31 no.12
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• pp.1110-1119
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• 2021

The purpose of this study was to investigate whether the inflammatory response in lipopolysaccharide (LPS)-treated RAW 264.7 macrophages could be promoted by particulate matter 2.5 (PM_2.5) stimulation. To this end, the levels of inflammatory parameters, reactive oxygen species (ROS) and inflammation-regulating genes were investigated in RAW 264.7 cells treated with PM_2.5 in the presence or absence of LPS. Our results showed that the production levels of pro-inflammatory mediators (nitric oxide and prostaglandin E₂) and cytokines (interleukin-6 and -1β) were significantly increased by PM_2.5 stimulation in LPS-treated RAW 264.7 cells, which was correlated with increased expression genes involved in their production. In addition, when LPS-treated RAW 264.7 cells were exposed to PM_2.5, nuclear factor-kappaB (NF-κB) expression was further increased in the nucleus, and the expression of inhibitor of NF-κB as well as NF-κB in the cytoplasm was decreased. These results suggest that the co-treatment of PM_2.5 and LPS further increases the activation of the NF-κB signaling pathway compared to each treatment alone, thereby contributing to the promotion of transcriptional activity of inflammatory genes. Furthermore, although the generation of ROS was greatly increased by PM_2.5 in LPS-treated RAW 264.7 cells, the NF-κB inhibitor did not reduce the generation of ROS. In addition, when the generation of ROS was artificially suppressed, the production of inflammatory mediators and the activation of NF-κB were both abolished. Therefore, our results suggest that the increase in the NF-κB-mediated inflammatory response induced by PM_2.5 in LPS-treated RAW 264.7 macrophages was a ROS generation-dependent phenomenon.

• Analytical Science and Technology
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• v.35 no.3
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• pp.136-142
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• 2022

According to media reports, the carcasses of euthanized abandoned dogs were processed at high temperature and pressure to make powder, and then used as feed materials (meat and bone meal), raising the possibility of residuals in the feed of the anesthetic ketamine and dexmedetomidine used for euthanasia. Therefore, a simultaneous analysis method using QuEChERS combined with high-performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry was developed for rapid residue analysis. The method developed in this study exhibited linearity of 0.999 and higher. Selectivity was evaluated by analyzing blank and spiked samples at the limit of quantification. The MRM chromatograms of blank samples were compared with those of spiked samples with the analyte, and there were no interferences at the respective retention times of ketamine and dexmedetomidine. The detection and quantitation limits of the instrument were 0.6 ㎍/L and 2 ㎍/L, respectively. The limit of quantitation for the method was 10 ㎍/kg. The results of the recovery test on meat and bone meal, meat meal, and pet food showed ketamine in the range of 80.48-98.63 % with less than 5.00 % RSD, and dexmedetomidine in the range of 72.75-93.00 % with less than 4.83 % RSD. As a result of collecting and analyzing six feeds, such as meat and bone meal, prepared at the time the raw material was distributed, 10.8 ㎍/kg of ketamine was detected in one sample of meat and bone meal, while dexmedetomidine was found to have a concentration below the limit of quantitation. It was confirmed that the detected sample was distributed before the safety issue was known, and thereafter, all the meat and bone meal made with the carcasses of euthanized abandoned dogs was recalled and completely discarded. To ensure the safety of the meat and bone meal, 32 samples of the meat and bone meal as well as compound feed were collected, and additional residue investigations were conducted for ketamine and dexmedetomidine. As a result of the analysis, no component was detected. However, through this investigation, it was confirmed that some animal drugs, such as anesthetics, can remain without decomposition even at high temperature and pressure; therefore, there is a need for further investigation of other potentially hazardous substances not controlled in the feed.

• Korean Journal of Psychosomatic Medicine
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• v.30 no.2
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• pp.73-79
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• 2022

Objectives : Suicide is a global social problem. Social burden caused by suicide is gradually increasing. Various efforts have been made to prevent suicide. Lifestyle changes to western style, especially diet changes, have increased the risk for suicide. Therefore, in this study, we discussed diet as an adjuvant treatment for suicide. Methods : In this review, we summarized the biochemical mechanism of suicide, and diet as a risk factor for suicide and diet as a protective factor through a web search. Results : In this study, biochemical mechanisms for suicide were reviewed and diet as a risk factor and diet as a protective factor for suicide were investigated. It was confirmed that neurotoxic effects such as oxidative stress and inflammation in the neural system could increase the risk of suicide. Based on results of previous studies on the relationship between suicide and diet, it was found that heavy use of alcohol, coffee, carbonated soft drink, and fast food were risk factors for suicide. Protective factors for suicide included antioxidants such as vitamin C, carotene, and anti-inflammatory agents such as omega-3 fatty acids found in seafood in large amounts. Conclusions : The only treatment for suicide is prevention. In this context, effectiveness, accessibility, and safety are important for preventing for suicide. Antioxidants and anti-inflammatory agents that are relatively safe and readily available to the public could be effective adjuvant treatments to decrease the risk of suicide. In addition, it is necessary to educate the public on reducing diets that could increase the risk of suicide

• Korean Journal of Agricultural and Forest Meteorology
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• v.24 no.4
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• pp.330-336
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• 2022

It is likely that the heading would occur early when air temperature increases. In 2022, however, the heading date was delayed unusually, e.g., by 3 to 5 days although temperature during the vegetative growth stage was higher than normal years. The objective of this study was to identify the cause of such event analyzing weather variables including average temperature, sunshine hours, and day-length for each growth stage. The observation data were collected for medium-late maturing varieties, which has been grown at crop yield experiment sites including Daegu, Andong, and Yesan. The difference in heading date was compared between growing seasons in 2021 and 2022 because crop management options, e.g., the cultivars and cultivation methods, were identical at those sites during the study period. It appeared that the heading date was delayed due to the difference in temperature responsiveness under a given day-length condition The effect of the temperature increase on the heading date differed between the periods during which when the day-length was more than 14.3 hours before and after the summer-solstice.. The effect of the temperature decrease during the period from which the day-length decreased to less than 14.3 hours to the heading date was relatively greater. This merits further studies to examine the response of rice to the temperature change under different day-length and sunshine duration in terms of heading.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.48 no.4
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• pp.365-372
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• 2022

Cellobiose is a dissacharide constituted by two glucose units joined by a β-('1,4') glycosidic bond that is produced by the decomposition of cellulose. This product exists naturally in plants and has been utilized in different industries as a food sweetener, and as a cosmetic and pharmaceutical material. In this study, the potential of cellobiose as a whitening cosmetic product was evaluated by analyzing autophagy induction and the inhibition of melanin production. A cytotoxicity test conducted in the human melanin-producing cell line MNT-1 with increasing concentrations of cellobiose revealed that this compound did not cause cytotoxicity at 20 mg/mL or less. Based on this, autophagy was firstly evaluated by immunostaining with the autophagy marker microtubule-associated protein 1 light chain 3 (LC3) after treatment with 20 mg/mL of cellobiose. The subsequent confocal microscopy analysis revealed an increase in LC3 puncta, indicating induction of autophagy. In addition, autophagy was further confirmed by western blot analysis, which demonstrated that cellobiose converted LC3-I to LC3- ∏ in a concentration- and time-dependent manners. An analysis of melanin contents after cellobiose treatment at a concentration of 20 mg/mL during 7 days revealed that melanin production was reduced by more than 50%. Additionally, the expression levels of melanogenesis-related proteins TYR and TYRP1 were markedly decreased after cellobiose treatment. Based on these studies, a cosmetic cream formulation containing cellobiose was prepared and the change in formulation was tested for 4 weeks, and it was confirmed that the appearance changed to liquid form at high temperature, but the pH did not change. In conclusion, the present research demonstrated that cellobiose activates autophagy and inhibits melanin production, and showed the potential of this product as a material for whitening cosmetics.

• Journal of Life Science
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• v.32 no.6
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• pp.447-454
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• 2022

In this study, we confirmed the effect of HK shiitake mushroom mycelium (HKSMM) on immune enhancement in Balb/c mice. Experimental animals were divided into five groups: negative control (NC), positive control (PC; 1,000 mg/100 g; AHCC), T1 (500 mg/100 g; HKSMM), T2 (1,000 mg/100 g; HKSMM), and T3 (2,000 mg/100 g; HKSMM), and dissection was performed at four and six weeks. COX-2 and iNOS concentrations were significantly lower in the six-week experimental group than in the control group, and the NO results were also similar. Results of the confirmation of the factors related to the NF-κB (p-p65 and p-IκBα) and MAPK (pERK, pJNK, and p38) signaling pathways revealed that the HKSMM-fed experimental group significantly decreased compared with the control group. A comparative analysis of the number and size of white pulp in the spleen tissue showed that those of the experimental group were significantly higher than those of the control group in a concentration-dependent manner. These results suggest that HKSMM has both immune-enhancing and anti-inflammatory effects in Balb/c mice, indicating that it can be used as a health functional food ingredient.

• Journal of the Korean Wood Science and Technology
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• v.32 no.4
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• pp.8-17
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• 2004

Antifungal, antibacterial, and antioxidative activities of ethanol extracts from 65 families 263 species were investigated to select tree species for the utilization of natural fungicide or preservative resources. The antifungal activities of extracts from wood, leaf and bark were measured as hyphal growth inhibition rate using four plant pathogenic and five wood rotting fungi. High inhibitory effect on the fungi growth was found in five species of Pinaceae (Pinus koraiensis, P. rigida, P. densiflora, P. banksiana. Cedrus deodara), three species of Cupressaceae (Juniperus rigida, J. chinensis, Chamaecyparis obtusa) and three species of Leguminosae (Albizzia julibrisssin, Sophora japonica, Maackia amurensis), respectively. Antibacterial activities of ethanol extracts were determined by means of disc-agar plate diffusion method using three gram-positive and five gram-negative bacteria. The ethanol extracts, which showed prominent effect on the suppression of bacteria growth, were six species of Betulaceae (Carpinus tschonoskii, C. coreana, C. laxiflora, Alnus hirsuta, A. firma, Betula schmidtii), five species of Fagaceae (Castanopsis cuspidata var. sieboldii, Quercus serrata, Q. mongolica, Q aliena, C crenata), four species of Euphorbiaceae (Aleurites fordii, Sapium sebiferum, S japonicum Mallotus japonicus) and three species of Elaeagnaceae (Elaeagnus umbellata, Elaeagnus glanbra, Elaeagnus macrophylla). According to these results, the extracts from Zelkova serrata, Pinus densiflora, Maackia amurensis, Chamaecyparis obtusa and Juniperus chinensis could be available for natural fungicide or food preservatives, because ethanol extracts from these species indicated excellent antifungal and antibacterial activities. In order to test antioxidative activities of ethanol extracts, free radical scavenging method was adopted with 1,1-diphenyl-2-picrylhydrohydrazyl (DPPH). Free radical scavenging activity was proved very high in the extracts of eight species of Rosaceae (Eriobotrya japonica, Prunus takesimensis, P yedoensis, P padus, P armeniaca var. ansu, Chaenomeles sinensis, Stephanandra incisa, Rosa multiflora) and five species of Ericaceae (Rhododenron mucronulatum, R. scblippenbacbii, R. yedoense var. poukhanense, Vaccinium bracteatum, V oldbami), resvectively. It turned out from this study that only six species among 48 species of Rosaceae showed less than 80% free radical scavenging activity. As a consequences, it could be deduced that the components effective on antioxidative activity commonly exist in Rosaceae plant family.