• YAKHAK HOEJI
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• v.58 no.2
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• pp.112-124
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• 2014

This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketed drugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a body of academic literature to explore current regulating trends. We included European Union, United Kingdom, United States of America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatory structure, safety control before and after off-label use, and information management. The findings of the present investigation called for several measures in off-label drug uses: enhancing prescribers' self-regulation, providing up-to-date information to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientific rigor, building an official registering process for off-label use in good quality and extending the role of pharmaceutical industry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses both at national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicants would submit. We newly introduced an official 'Off-Label Drug Use Report' to evaluate the safety and clinical efficacy of a given off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institution to help set up the culture of evidence-based practices in off-label drug uses.

• Journal of Applied Biological Chemistry
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• v.61 no.4
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• pp.305-314
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• 2018

'New Breeding Techniques (NBTs)' have been one of hot issues, since their future will be affected profoundly by national as well as international regulatory landscapes. In this review, we compare characteristics of NBTs with conventional and genetic modification, and analyze genetically modified organism (GMO) regulatory systems in the context of possible regulation of NBTs. NBTs are very heterogeneous in terms of principles, methodologies, and final products. As Living Modified Organisms (LMO) is defined in the Cartagena Protocol on Biosafety (CPB) as an organism containing novel combination of genetic materials obtained by the use of modern biotechnology, CPB as well as other national legislations locate itself somewhere in the middle between product-based and process-based regulations. It is also noted that jurisdictions with regulatory systems more oriented to product-based one tend to be more productive and decide or may decide to exempt site-directed nucleases-1 from GMO regulation. In this context, Korean legislations are reviewed to clarify the commons and differences in GMO definitions. Act on Transboundary Movement of LMO Act, Food Sanitation Act and Agricultural and Fishery Products Quality Control Act are three major acts to regulate GMOs. It is noted that there are differences in the definition of LMO or GM food/products especially between the LMO Act and the Food Sanitation Act. Such differences may cause conflicts between Acts when policy-decision regarding the regulation of NBTs is made. Therefore, it is necessary to reorganize legislations before policies regarding the regulation of any techniques from biotechnology are made.

• Journal of Korean society of Dental Hygiene
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• v.24 no.2
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• pp.187-195
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• 2024

Objectives: This study aimed to explore ways to improve the level of positive psychological capital of dental hygiene students. After comparing the levels of positive psychological capital, social support, and emotional regulation ability of dental hygiene students and identifying correlations, the sub-factors of social support and emotional regulation ability that affect positive psychological capital were identified. Methods: A survey of 70 questions was conducted targeting 310 dental hygiene students in Gyeonggi-do and Chungcheong-do. The results were subjected to exploratory factor analysis, frequency analysis, t-test, one-way ANOVA, correlation analysis, and multiple regression analysis using the PASW statistics 18.0 program. Results: The level of positive psychological capital was high when students had high grades and perceived positive relationships with professors and peers (p<0.001). Factors highly correlated with positive psychological capital include 'self-emotional regulation ability' among 'emotion regulation abilities' (r=0.665, p<0.001), and 'emotional support related to daily life' recognized 'social support' (r=0.635, p<0.001), followed by 'social support' (r=0.602, p<0.001). Factors affecting positive psychological capital include 'self-emotion recognized ability' (β=0.377, p<0.001), 'quality of professor relationship' (β=0.201, p<0.001), and 'emotion control ability'. Among 'social support', 'emotional support related to daily life' (β=0.201, p=0.003) and 'grades' (β=0.159, p<0.001), and among 'social support', 'social-related support' (β=0.149, p=0.016), followed by 'grade' (β=0.076, p=0.043) were identified. Conclusions: To improve the positive psychological capital of dental hygiene students, efforts should be made to improve self-emotion regulation ability, professor relationships, emotional support related to daily life, and social support.

• Animal Bioscience
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• v.37 no.1
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• pp.95-104
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• 2024

Objective: In the present study, we aimed to investigate the effects of enzymolysis fermentation of Chinese herbal medicines (CHMs) on egg production performance, egg quality, lipid metabolism, serum reproductive hormone levels, and the mRNA expression of the ovarian hormone receptor of laying hens in the late-laying stage. Methods: A total of 360 Hy-Line Brown laying hens (age, 390 days) were randomly categorized into four groups. Hens in the control (C) group were fed a basic diet devoid of CHMs, the crushed CHM (CT), fermented CHM (FC), and enzymatically fermented CHM (EFT) groups received diets containing 2% crushed CHM, 2% fermented CHM, and 2% enzymatically fermented CHM, respectively. Results: Compared with crushed CHM, the acid detergent fiber, total flavonoids, and total saponins contents of fermented CHM showed improvement (p<0.05); furthermore, the neutral and acid detergent fiber, total flavonoids, and total saponins contents of enzymatically fermented CHM improved (p<0.05). At 5 to 8 weeks, hens in the FC and EFT groups showed increased laying rates, haugh unit, albumin height, yolk color, shell thickness, and shell strength compared with those in the C group (p<0.05). Compared with the FC group, the laying rate, albumin height, and Shell thickness in the EFT group was increased (p<0.05). Compared with the C, CT, and FC groups, the EFT group showed reduced serum total cholesterol and increased serum luteinizing hormone levels and mRNA expressions of follicle stimulating hormone receptor and luteinizing hormone receptor (p<0.05). Conclusion: These results indicated that the ETF group improved the laying rate and egg quality and regulated the lipid metabolism in aged hens. The mechanism underlying this effect was likely related to cell wall degradation of CHM and increased serum levels of luteinizing hormone and mRNA expression of the ovarian hormone receptor.

• Proceedings of the KSR Conference
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• 2006.11b
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• pp.1210-1213
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• 2006

Indoor air quality is an important determinant of human health and comfort. However, the complexity of pollution sources and the multitude of parties responsible for creating indoor exposures makes the improvement of air quality difficult. The KTX HVAC(Heating, Ventilating and Air-Conditioning) system is important facility to provide comfortable environment passenger service. The Ministry of Environment is planning to enforce$\square\square$Indoor Air Quality Management law in Public Facilities$\square\square$in year 2008. Hereupon, the train and the subway are included. In this research air quality in the KTX Train compartment has measured. As a result, The average amounts of PM10(particulate matters), $CO_2$(carbon dioxide)measured $20{\mu}g/m^3$, 1,097ppm in KTX respectively. There are compare to regulation the value is 10% for PM10 and 43% for $CO_2$. Thus, the indoor air quality of KTX train have been proved satisfy the recommendation the Ministry of Environment guidelines.

• Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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• 2013.10a
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• pp.513-518
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• 2013

The purpose of vehicle horn sound is for warning to pedestrians. In the past, the main development factor is to match the regulation level. But nowadays perceived quality is more important than level itself. In this study, we measure variety horn sound and evaluate its signals through the jury evaluation aimed at making horn sound quality index. Each contribution of the noise path for sound quality is identified and the target values and methods for implementing the luxurious horn sound are suggested. Finally, we developed, horn component and improve horn mounting condition for luxurious horn sound.

• Journal of the Korean Society of Safety
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• v.33 no.1
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• pp.73-80
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• 2018

According to the statistics publication of KOSHA, more than half of serious accidents at the construction sites were related to the temporary works and/or the temporary structures such as scaffoldings, shores, earth retaining walls, etc. The structural failures are occurred because of the overload acting on the structures or lack of performance of the one or more members of the structures. For the prevention of the collapse accidents relating to the temporary structures at the construction sites, we have to control construction processes not to occur the overload and also to control the performance and quality of each member of the temporary structures. MOLIT has amended the "Construction Technology Promotion Act" on Jan. 7th, 2015 to ensure the structural safety of the temporary structures. According to the Act, the designers of the construction design projects should check the structural integrity of the structures including the temporary structures and the construction companies have to let 'the Relative Professionals' confirm the structural integrity of temporary structures, the shores(${\geq}5m$ high) and the scaffolds(${\geq}31m$ high), before construction. Also, MOLIT has amended the "Regulation for Construction Technology Promotion Act" on Jul. 4th, 2016 for quality management and testing of temporary equipments. According th this regulation, the construction companies and supervisors should manage and test the temporary equipments before using them. In this paper, the standard drawings of the shores(< 5 m high) and the scaffolds(< 31 m high) and the amended "Business Guideline for Quality Management of Construction Work" are presented. As the result of this study, MOLIT noticed the amended "Business Guideline for Quality Management of Construction Work" on Jul. 1st, 2017.

• Journal of Korean Society of Water and Wastewater
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• v.27 no.5
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• pp.591-601
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• 2013

In modern society, we are living indoor at 80 - 90 % or more of the day, therefore most people are exposed to unconscious indoor air pollutants by various causes. When mother and infant, whose level of immunity are weak, are exposed to polluted indoor air, respiratory diseases and atopy can occur by the growth of bacteria. Therefore, appropriate indoor air quality management is important especially at nursery, elementary school and postpartum clinic etc. In this study, we compared the characteristics of the indoor air qualities of primary school facilities and infant facilities. In this study, seasonal effects were investigated. Also the effects of individual activity area were studied for indoor air quality. During summer season(May-August), the air qualities of each 16 elementary school and nursery school were investigated. During winter season(October-december), the air qualities of each 10 elementary school and nursery school were investigated. As a result, during winter season in 10 of 16 nursery school, $CO_2$ concentration exceeded regulation level of 1000 ppm. This resulted from the operation of heating system and poor ventilation. Also the air quality of all parameters during winter season were worse than during summer, maybe due to poor ventilation. Except HCHO, the concentrations of other parameters were higher in nursery school. This seems to result from relatively low individual activity area of nursery school than elementary school. From this research, more strong regulation for ventilation and installation of air purifier should be implemented.

• Proceedings of KOSOMES biannual meeting
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• 2018.06a
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• pp.167-167
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• 2018

• Proceedings of the KSR Conference
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• 2007.05a
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• pp.1325-1329
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• 2007

Indoor air quality is an important determinant of human health and comfort. However, the complexity of pollution sources and the multitude of parties responsible for creating indoor exposures makes the improvement of air quality difficult. The HVAC(Heating, Ventilating and Air-Conditioning) system is important facility to provide comfortable environment passenger service. The Ministry of Environment is established "Indoor Air Quality Management guidelines in Public Facilities"in December 2006. Hereupon, the train and the subway are included. In this research air quality in the Subway compartment has been measured. As a result, the concentrations of PM10 and $CO_2$ were reached to 93% and 61% of the regulation values, respectively. Thus, the indoor air qualities of subway have been proved that they satisfy the recommended guidelines by the Ministry of Environment.