• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• Journal of the Korea Institute of Information and Communication Engineering
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• v.10 no.7
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• pp.1246-1252
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• 2006

Recently, customers interest increase in the agricultural product safety when receiving the many information about food problem due to the development of media. Such amid, domestic agricultural environment don't have a system that safety certification of agricultural product. At this rate, domestic agricultural products will decrease the competitive power and apprehend by the giving a market to foreign agricultural product. In this paper, we designed and implementation of AIGT system for the improvement of agricultural environment to producing the agricultural product safety and customers' reliability increase to offering clear information. Also, we defined the right data structure for agricultural environment. The monitoring and video conference are imported for efficient improvement of environment.

• Journal of the Korean Society of Food Science and Nutrition
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• v.40 no.1
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• pp.123-127
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• 2011

This study was conducted to decrease the microbial hazard in kimchi saline water with microwave plasma sterilization system and to evaluate the inactivation of foodborne pathogens by the microwave plasma sterilization system as a non-thermal treatment. Contamination of coliform, Escherichia coli, and yeasts and molds were detected in the used saline water, and the microbial populations increased as the saline water was reused repeatedly. The $D_{10}$-values of E. coli O157:H7, Salmonella Typhimurium, and Listeria monocytogenes by the microwave plasma sterilization system were 0.48, 0.52, and 0.45 cycle, respectively. In addition, the microbial populations of coliform, E. coli, Salmonella spp., total aerobic bacteria, and yeasts and molds in the used kimchi saline water were significantly decreased by treating the saline water using the microwave plasma sterilization system. Therefore, these results suggest that microwave plasma sterilization system can be useful in improving the microbial safety of the used saline water.

• Food Science of Animal Resources
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• v.43 no.6
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• pp.1128-1149
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• 2023

In order to extend the shelf life of refrigerating raw lamb by inhibiting the growth of microorganisms, preventing the oxidation of fat and protein, and absorbing the juice outflow of lamb during storage, an active packaging system based on plastic/gelatin bilayer film with essential oil was developed in this study. Three kinds of petroleum-derived plastic films, oriented polypropylene (OPP), polyethylene terephthalate, and polyethylene, were coated with gelatin to make bilayer films for lamb preservation. The results showed significant improvement in the mechanical properties, oxygen, moisture, and light barriers of the bilayer films compared to the gelatin film. The OPP/gelatin bilayer film was selected for further experiments because of its highest acceptance by panelists. If the amount of juice outflow was less than 350% of the mass of the gelatin layer, it was difficult for the gelatin film to separate from lamb. With the increase in essential oil concentration, the water absorption capacity decreased. The OPP/gelatin bilayer films with 20% mustard or 10% oregano essential oils inhibited the growth of bacteria in lamb and displayed better mechanical properties. Essential oil decreased the brightness and light transmittance of the bilayer films and made the film yellow. In conclusion, our results suggested that the active packaging system based on OPP/gelatin bilayer film was more suitable for raw lamb preservation than single-layer gelatin film or petroleum-derived plastic film, but need further study, including minimizing the amount of essential oil, enhancing the mechanical strength of the gelatin film after water absorption.

• Food Science and Industry
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• v.50 no.1
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• pp.16-25
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• 2017

There is no doubt that accumulation of big data using multi-omics technologies will be useful to solve human's long-standing problems such as development of personalized diet and medicine, overcoming diseases, and longevity. However, in the food industry, big data based on omics is scarcely accumulated. In particular, comprehensive analysis of molecular lipid metabolites directly associated with food quality, such as taste, flavor, and texture has been very limited. Moreover, most of food lipidomics studies are applied to analyze lipid components and discriminate authenticity and freshness of limited foods including vegetable and fish oil. However, if lipid big data through food lipidomics research of various foods and materials can be accumulated, lipidomics can be used in the optimization of food processing, production, delivery system, food safety, and storage as well as functional food.

• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.13 no.5
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• pp.389-396
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• 2020

In this paper, a cultivation traceability system to implement smart agriculture developed and implemented, and in particular, devised a system that manages the cultivation traceability of grains that are difficult to grow in smart farms. Mobile and web programs based on smart devices are designed, and the collected information is stored in a DB server and can be used as big data. In addition, real-time location information and agricultural activity information can be matched using an electronic map(Vworld) based on GIS/LBS applying GPS of a mobile device. By designing the cultivation traceability information DB required in the field, the farmhouse, farmers, and cultivation information were developed to make it easy for managers to use, and implemented mobile and web programs in the field. The system is expected to raise the quality and safety management capabilities to the next level in response to variables such as labor saving effect and climate change.

• Journal of the Korean Society of Food Science and Nutrition
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• v.43 no.8
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• pp.1207-1216
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• 2014

Vegetables contain high levels of nitrate, which can be converted to nitrite for reaction with secondary amines to form nitrosamines. In this study, we evaluated safety effects against nitrite and nitrosamine as well as anti-mutagenic activities of vegetable juices. To do this, the contents of nitrate, nitrite, and nitrosamines were determined in vegetable juices. The safety effects against nitrite and nitrosamine formation were also investigated under simulated human gastric conditions. The contents of nitrate and nitrite in common and organic kale and Angelica keiskei juices were 931~2,052 mg/kg and 13~82 mg/kg, respectively. However, seven kinds of nitrosamines were not detected in the vegetables juices. The nitrate content decreased when vegetable juices were digested under simulated human gastric conditions. Nitrosamine (N-nitrosodimethylamine) formation under simulated human gastric conditions was inhibited by addition of vegetable juices. In addition, vegetable juices, especially organically cultivated juices, showed anti-mutagenic effects in a Salmonella assay system. These results suggest that organically cultivated vegetable juices are a promising health-promoting source.

• Journal of Biomedical Engineering Research
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• v.44 no.2
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• pp.99-108
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.

• Journal of Biosystems Engineering
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• v.31 no.2 s.115
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• pp.128-134
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• 2006

Frequent outbreaks of foodborne illness demand the need for rapid and sensitive methods for detection of these pathogens. Recent development of biosensor technology has a great potential to meet the need for rapid and sensitive pathogens detection from foods. An antibody-based fiber-optic biosensor and an automated reagents supply system to detect Listeria monocytogenes were developed. The biosensor for detection of Listeria monocytogenes in PBS and bacteria spiked food samples was evaluated. The automated reagents supply system eliminated cumbersome sample and detection antibody injection procedures that had been done manually. The biosensor could detect $10^4$ cfu/ml of Listeria monocytogenes in PBS. By using the fiber-optic biosensor, $2x10^8$ cfu/ml of Listeria monocytogenes in the food samples were detectable.

• Korean Journal of Organic Agriculture
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• v.20 no.2
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• pp.161-172
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• 2012

This study was carried out to estimate carbon footprint and to establish of LCA of garlic production system. We have case study in cultivate garlic 1 kg calculate in carbon footprint. LCA carried out to estimate carbon footprint and to establish of LCI (life cycle inventory) database of garlic production system. The data is from Research of Farmer's income in 2010 (RDA, 2011), and used Pass (5.0.0) program. The value of fertilizer, amount of pesticide input were shown the environmental effect and direct emission. Carbon footprint in agriculture guarantees the choice right the consumer to choose the lower carbon goods. Its can make to strengthen of agriculture and food industry's reduction effort of $CO_2$. Nowadays consumer requests food's safety and environment friendly process. Carbon footprint also needs consumer's relief and incentives.