• Journal of Preventive Medicine and Public Health
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• v.55 no.5
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• pp.464-474
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• 2022

Objectives: We introduced the cohort studies included in the Korean Cohort Consortium (KCC), focusing on large-scale cohort studies established in Korea with a prolonged follow-up period. Moreover, we also provided projections of the follow-up and estimates of the sample size that would be necessary for big-data analyses based on pooling established cohort studies, including population-based genomic studies. Methods: We mainly focused on the characteristics of individual cohort studies from the KCC. We developed "PROFAN", a Shiny application for projecting the follow-up period to achieve a certain number of cases when pooling established cohort studies. As examples, we projected the follow-up periods for 5000 cases of gastric cancer, 2500 cases of prostate and breast cancer, and 500 cases of non-Hodgkin lymphoma. The sample sizes for sequencing-based analyses based on a 1:1 case-control study were also calculated. Results: The KCC consisted of 8 individual cohort studies, of which 3 were community-based and 5 were health screening-based cohorts. The population-based cohort studies were mainly organized by Korean government agencies and research institutes. The projected follow-up period was at least 10 years to achieve 5000 cases based on a cohort of 0.5 million participants. The mean of the minimum to maximum sample sizes for performing sequencing analyses was 5917-72 102. Conclusions: We propose an approach to establish a large-scale consortium based on the standardization and harmonization of existing cohort studies to obtain adequate statistical power with a sufficient sample size to analyze high-risk groups or rare cancer subtypes.

• The Korean Society of Law and Medicine
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• v.23 no.2
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• pp.119-139
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• 2022

Brain stimulation technology that administers electrical and magnetic stimulation to a brain has shown a significant level of possibility for treating a wide range of various neurological and psychiatric disorders. Depending on its nature, the technology is defined either as invasive or non-invasive, and deep brain stimulation (DBS) is one of the most well-known invasive brain stimulation technologies. Currently categorized as grade 4 medical device in accordance with Guideline On Medical Devices And Their Grades, a Notification of Ministry of Food and Drug Safety (MFDS), the DBS has been used as a stable treatment for several diseases. At the same time, the DBS technology has recently achieved substantial advancement, encouraging active discussions for its use from various perspectives. On the contrary, debates over legal regulation related to the use of DBS has relatively been smaller in numbers. In this context, this article aims to 1) introduce the DBS technology and its safety in setting out the tone; 2) touch upon major legal issues that would potentially rise from its use for four different purposes of treatment, clinical study, areas of non-standard treatment where no other methods are available, and enhancement; and finally 3) highlight disputes concerning common emerging issues observed in the aforementioned four purposes from the viewpoint of legal responsibility and liability of using the DBS, which are benefit-risk assessment, physicians' duty of information, patients' capacity to consent, control for device, and insurance coverage.

• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.159-184
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• 2021

The significance of the enactment of the 「Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products」 is to break away from the regulation of the Pharmaceutical Affairs Act and expand patient treatment opportunities through a medical technology approach to regenerative medicine, which is essentially a medical practice called 'transplantation'. However, more than a year after the law was enacted, clinical study has not been activated, with not a single high-risk study approved by the Ministry of Food and Drug Safety being approved. The reason is that despite the legal purpose of expanding patient treatment opportunities, the data requirements for clinical study approval are set in connection with drug development despite the insufficient legal basis, making it difficult for many researchers to meet the data requirements. Prior to the enactment of the Act, submitted data for clinical study on cell therapy products within the Pharmaceutical Affairs Act were cosiderably exempted from quality and non-clinical test data, but with the enforcement of the Advanced Regenerative Bio Act, quality and non-clinical test data are required in accordance with pharmaceuticals when applying for approval of a clinical study plan. To rectify this, when considering the identity of clinical study on advanced regenerative medicine to expand treatment opportunities, recognize that there are limitations in connection with drug development. And it is necessary to preserve the identity of clinical study on advanced regenerative medicine, and on the other hand, in the case of drug product approval, clinical study results should be utilized while specifying usage requirements. Therefore, with the power of the market and the voluntary motive of the clinical researcher, it is necessary to prepare the necessary data by themselves rather than the basic requirements for clinical study approval.

• Journal of Nutrition and Health
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• v.55 no.5
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• pp.523-532
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• 2022

Vitamin C is an important physiological antioxidant which neutralizes reactive oxygen species (ROS) and reduces the oxidative stress in the body. Although it has been associated with various diseases, few studies have reported the dose-response relationship between vitamin C intake, storage and functions in the body, including its antioxidant function. The criteria to establish the Dietary Reference Intakes for Koreans (KDRIs) for vitamin C were based on the changes in plasma concentrations and saturation of leukocytes according to intake levels and the effects on antioxidant capacity and risk of metabolic diseases. When establishing the 2020 vitamin C KDRI, while there was no change in the criteria from those of 2015, the reference values were recalculated and revised to reflect changes such as the new standard weight by age. As the number of people consuming dietary supplements has increased over the last decade, only about 10% of adults consume less than the average total vitamin C, but the proportion of adolescents and elderly who consume less than the average is high. On the other hand, as the intake of vitamin C supplements increases, the proportion of people consuming excessive vitamin C is also increasing. There is a body of opinion that it is necessary to establish a vitamin C KDRI for smokers or people with chronic diseases such as the metabolic syndrome, but these standards have not been established due to the lack of supporting scientific evidence. As a result, studies to establish vitamin C KDRI for Korean smokers and patients with the metabolic syndrome, as well as studies on the excessive intake of vitamin C due to supplementation and interactions with other nutrients, are needed.

• The Korea Journal of Herbology
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• v.38 no.2
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• pp.1-7
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• 2023

Objectives : From this study, we sight to identify Anti-stress effect of Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex Methods : In order to measure the degree of functional evaluation of tension relief due to stress, it was evaluated whether the psychological indicators VAS(Visual Analog Scale) and POMS(Profile Of Mood State) were improved. Which is generally used for stress measurement and has a high frequency of clinical use. All clinical trial subjects were required to take the drug once a day at 9 ± 30 min in the morning for 2 weeks. Results : After intake, the group that Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had a statistically significant improvement effect compared to before intake due to an improved 30.81% of the VAS scores. The POMS-T score improved 54.13%, the POMS-V score improved 117.5% and the POMS-F score improved 59%, which had a statistically significant effect compared to Placebo group (p<0.001). There is a significant difference between two group, so even considering the placebo effect, the anti stress effect was confirmed in the Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex intake group. Conclusions : The above results showed that the Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had an anti-stress effect. Therefore, it is expected to be developed as a safe and comfortable mental care health functional food that can reduce the risk of drug abuse.

• Korean Journal of Environmental Agriculture
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• v.42 no.1
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• pp.63-70
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• 2023

Golden apple snails (Pomacea canaliculat) (GAS) are widely used for weed control in rice cultivation. However, concerns on the ecological risk of invasive GAS species are increasing. This study aimed to evaluate the overall impacts of GAS on weed control, abundance of aquatic animals and insects, and rice yield, in comparison with that from other biocontrol agents such as loach (Misgurnus mizolepis) and catfish (Silurus asotus), which are alternatives for biological weed control in rice paddy cultivation. Field experiments included five treatments; control, herbicide, GAS, loach, and catfish. During the rice growth, weed appearance and biological abundance were monitored, and at harvest, the rice yield was determined. Weed control efficiency was the highest for GAS treatment (100%), followed by that for herbicide (95.8%), loach (57.5%), and catfish treatments (31.7%). Insect abundance was considerably decreased in GAS treatment due to heavy weed removal, which affects the habitat of aquatic animals and insects. The amount of rice yield (unit: kg 10 a^-1) was in the order of GAS (798.9) > loach (708.1) = herbicide (700.7) > catfish (629.4) > control (496.0). Therefore, considering the weed control efficiency, biological abudance, and rice yield, loach could be a potential alternative for biological weed control in organic rice farming. However, the activity of the biocontrol agents are susceptible to environmental conditions; therefore, further studies under different conditions are essential to confirm these findings.

• Journal of Environmental Health Sciences
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• v.49 no.6
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• pp.289-294
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• 2023

Background: Artificial sweeteners are chemically synthesized substances used to add sweetness to foods. Representative substances include aspartame and acesulfame-K, which are 200 times sweeter than sugar. Recently, the IARC classified aspartame as class 2B, but Ministry of Food and Drug Safety of South Korea announced that it would maintain the current usage standards. Acesulfame-K, which has the potential to cause cancer, was excluded from the list of possible carcinogens, raising questions about its safety. According to a survey by the Consumers Union of Korea, 85% of makgeolli includes artificial sweeteners, but the content labelling is not indicated. It is necessary to accurately determine the intake of artificial sweeteners through makgeolli. Objectives: This study aims to evaluate the safety of makgeolli consumption by identifying the content of artificial sweeteners (aspartame, acesulfam-K) and preservatives (sorbic acid). Methods: Twenty makgeolli samples were purchased from large supermarkets and convenience stores by referring to the sales ranking of makgeolli products distributed in South Korea and the purchase ranking from online sites. The sample was sonicated to remove alcohol and carbon dioxide. Nine mL of acetonitrile was mixed with 1 mL of the prepared sample, centrifuged, and the supernatant was filtered and analyzed using HPLC. Results: As a result of the analysis, aspartame was detected in 17 products and acesulfame-K was detected in ten. The ADI of aspartame (40 mg/kg·bw/day) is higher than the EDI based on the maximum concentration 126.5 ㎍/mL. The ADI of acesulfame-K (15 mg/kg·bw/day) is higher than the EDI based on the highest concentration of 82.96 ㎍/mL. Although the health risk is low, IARC has raised the possibility of aspartame causing carcinogenesis, so there is a need to reevaluate the standards and regulations for artificial sweeteners. Conclusions: Through this study, we aimed to determine the content of aspartame and acesulfame-K contained in makgeolli currently distributed in South Korea and the safety of exposure to the human body when consumed.

• Health Policy and Management
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• v.34 no.2
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• pp.106-119
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• 2024

Drug shortage is a persistent phenomenon that poses a public health risk worldwide and occurs due to a range of causes. The purpose of this study is to review key policies to prepare for and respond to drug shortages in selected countries, such as the United States, Canada, and some European countries in order to draw implications. This study reviewed the reports and articles derived from search engines and Google Scholar by using keywords such as drug shortage and stock-out. Over the last decade or so, the United States have strengthened requirements on advance notification for disruption and interruption of drug manufacturing, established the Inter-agency Drug Shortages Task Force to promote the communication and coordination of responses, and expedited drug regulatory processes. Similarly, Canada established the Multi-Stakeholder Steering Committee on drug shortages by involving representatives from central and local governments and private sectors. Canada also adopted a tiered approach to the communication of drug shortages based on the assessment of the severity of the shortage problem and released a detailed information guide on communication. In 2019, the joint task force between the European Medicines Agency and the Heads of Medicines Agencies issued guidelines on drug shortage communication in the European Economic Area. The countries reviewed in this paper focus on communication across different stakeholders for the monitoring of and timely response to drug shortages. The efforts to protect public health from the negative impact of the drug shortage crisis would require multi-sectorial and multi-governmental coordination and development of guidelines.

• Journal of Environmental Health Sciences
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• v.50 no.2
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• pp.102-112
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• 2024

Background: Despite the rise in the number of domestic indoor climbing gyms, there is a lack of specific hygiene standards and research on the holds installed in them. Holds can act as vectors for microbial transmission through the hands, posing a risk of infectious diseases, especially with damaged skin. Objectives: The aim of this study is to investigate the contamination level and species of microorganisms on holds according to the management methods practiced in indoor climbing gyms and identify effective strategies for reducing microbial contamination. Methods: We investigated factors that may influence microbial contamination of holds, including hold management methods, user information, and hygiene management at three climbing gyms in Seoul. A total of 72 holds were sampled, 18 for each management method of brushing, high-pressure washing, and ethanol disinfection. Samples were cultured on LB and blood agar at 37℃ for 48 hours to calculate CFUs. PCR assay targeting 16S rRNA was carried out to identify microorganisms. Dunn-Bonferroni was employed to see the microbial reduction effect of the management method and the difference in microbial contamination by management method and climbing gym. Results: As a result of microbial identification, microorganisms such as Bacillus, Staphylococcus, and Micrococcus, which were derived from various environments such as skin and soil, were discovered on the surface of the climbing hold. Among the discovered microorganisms, some species had potential pathogenic properties that could cause food poisoning, gastrointestinal disease, bacteremia, and sepsis. All hold management methods were effective in reducing microorganisms (p<0.05), with ethanol disinfection being the most effective (p<0.001). Conclusions: Our results indicate that there are potential pathogens on holds that demand thorough management for microbial prevention. Proposed methods include regular brushing and ethanol disinfection in addition to high-pressure washing with long cycles, which are the existing forms of hold management. Further studies on shoe management are advised to curb soil-derived microorganisms.

• Korean Journal of Agricultural and Forest Meteorology
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• v.15 no.2
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• pp.109-117
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• 2013

The Global Framework on Climate Services (GFCS) will guide the development of climate services that link science-based climate information and predictions with climate-risk management and adaptation to climate change. GFCS structure is made up of 5 pillars; Observations/Monitoring (OBS), Research/ Modeling/ Prediction (RES), Climate Services Information System (CSIS) and User Interface Platform (UIP) which are all supplemented with Capacity Development (CD). Corresponding to each GFCS pillar, the Commission for Agricultural Meteorology (CAgM) has been proposing "Global Initiatives in AgroMeteorology" (GIAM) in order to facilitate GFCS implementation scheme from the perspective of AgroMeteorology - Global AgroMeteorological Outlook System (GAMOS) for OBS, Global AgroMeteorological Pilot Projects (GAMPP) for RES, Global Federation of AgroMeteorological Society (GFAMS) for UIP/RES, WAMIS next phase for CSIS/UIP, and Global Centers of Research and Excellence in AgroMeteorology (GCREAM) for CD, through which next generation experts will be brought up as virtuous cycle for human resource procurements. The World AgroMeteorological Information Service (WAMIS) is a dedicated web server in which agrometeorological bulletins and advisories from members are placed. CAgM is about to extend its service into a Grid portal to share computer resources, information and human resources with user communities as a part of GFCS. To facilitate ICT resources sharing, a specialized or dedicated Data Center or Production Center (DCPC) of WMO Information System for WAMIS is under implementation by Korea Meteorological Administration. CAgM will provide land surface information to support LDAS (Land Data Assimilation System) of next generation Earth System as an information provider. The International Society for Agricultural Meteorology (INSAM) is an Internet market place for agrometeorologists. In an effort to strengthen INSAM as UIP for research community in AgroMeteorology, it was proposed by CAgM to establish Global Federation of AgroMeteorological Society (GFAMS). CAgM will try to encourage the next generation agrometeorological experts through Global Center of Excellence in Research and Education in AgroMeteorology (GCREAM) including graduate programmes under the framework of GENRI as a governing hub of Global Initiatives in AgroMeteorology (GIAM of CAgM). It would be coordinated under the framework of GENRI as a governing hub for all global initiatives such as GFAMS, GAMPP, GAPON including WAMIS II, primarily targeting on GFCS implementations.