• Laboraroty Animal Research
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• v.34 no.4
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• pp.232-238
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• 2018

Animal models have been used to elucidate the pathophysiology of varying diseases and to provide insight into potential targets for therapeutic intervention. Although alternatives to animal testing have been proposed to help overcome potential drawbacks related to animal experiments and avoid ethical issues, their use remains vital for the testing of new drug candidates and to identify the most effective strategies for therapeutic intervention. Particularly, the study of metabolic diseases requires the use of animal models to monitor whole-body physiology. In line with this, the National Institute of Food and Drug Safety Evaluation (NIFDS) in Korea has established their own animal strains to help evaluate both efficacy and safety during new drug development. The objective of this study was to characterize the response of C57BL/6NKorl mice from the NIFDS compared with that of other mice originating from the USA and Japan in a chemical-induced diabetic condition. Multiple low-dose treatments with streptozotocin were used to generate a type-1 diabetic animal model which is closely linked to the known clinical pathology of this disease. There were no significantly different responses observed between the varying streptozotocin-induced type-1 diabetic models tested in this study. When comparing control and diabetic mice, increases in liver weight and disturbances in serum amino acids levels of diabetic mice were most remarkable. Although the relationship between type-1 diabetes and BCAA has not been elucidated in this study, the results, which reveal a characteristic increase in diabetic mice of all origins are considered worthy of further study.

• Microbiology and Biotechnology Letters
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• v.50 no.2
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• pp.310-318
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• 2022

The fruits of Paulownia tomentosa (Thunb.) (PT) Steud. have been reported to exert a variety of biological activities. A previous study confirmed that compounds isolated from PT fruits (PTF) exerted anti-inflammatory effects on TNF-α-stimulated airway epithelial cells. However, there is no report on the protective effects of PTF on acute lung injury (ALI). Here, we examined the ameliorative effects of PTF in an experimental animal model of lipopolysaccharide (LPS)-induced ALI. In ALI mice, increased levels of inflammatory cell influx were confirmed in the lungs of mice, and an increase of microphage numbers, TNF-α, IL-6 and MCP-1 production and protein content were detected in mouse bronchoalveolar lavage fluid. However, these increases were significantly reversed with PTF pretreatment. In addition, PTF inhibited the increased expression of iNOS and COX-2 in the lungs of ALI mice. Furthermore, the upregulation of MAPK and NF-κB activation was decreased in the lungs of ALI mice by PTF. In the in vitro experiment, PTF pretreatment exerted an anti-inflammatory effect by inhibiting the secretion of nitric oxide, TNF-α and IL-6 in LPS-stimulated RAW264.7 macrophages. Collectively, these results indicated that PTF has ameliorative effects on airway inflammation in an experimental animal model of ALI.

• Journal of Veterinary Clinics
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• v.40 no.2
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• pp.113-118
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• 2023

Skin and joint diseases are relatively common in dogs. Nutritional complementation is one of the various management strategies for these disorders. This study evaluated the safety and clinical efficacy of Kyungokgo-gamibang in dogs with skin and joint diseases. Thirty dogs with diseases were included and divided into three groups: control group (n = 15), skin group (n = 10), and joint group (n = 5). The skin and joint groups were fed skin and joint gums composed of Kyungokgo-gamibang extract with standard treatment for four weeks. The control group included dogs with skin diseases who were administered standard skin infection treatment for 4 weeks. The physical and laboratory results showed no remarkable adverse effects of Kyungokgo-gamibang extract after its administration in dogs. Clinical efficacy was evaluated using quality of life scale, and levels of cytokines, including interferon-γ, interleukin (IL)-2, IL-6, IL-8, IL-10, monocyte chemoattractant protein-1, and tumor necrosis factor-α, for 4 weeks in all groups. Dermatologic clinical scales were performed for 4 weeks in the control and skin groups. Both the control and skin groups had significantly decreased dermatologic clinical scales, including pruritus and erythema scales (p < 0.05). Among the cytokine levels, only IL-2 concentration was significantly decreased in the skin group after 4 weeks of administration of the Kyungokgo-gamibang extract (p = 0.032). There was no significant difference between the levels of cytokines on days 0 and 28 in the joint group. The quality of life scale was significantly increased after week 4 compared to week 0 in the skin (p = 0.008) and joint groups (p = 0.041). This study suggests that Kyungokgo-gamibang extract can be applied in managing dogs affected by skin and joint diseases without adverse effects.

• Journal of the Korean Society of Food Science and Nutrition
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• v.46 no.4
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• pp.490-500
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• 2017

This study was performed to evaluate repeated dose oral toxicity upon administration of the test substance 1,2-benzisothiazolin-3-one for 90 days and to determine NOAEL (no observed adverse effect level) and target organs in Sprague-Dawley rats. Single, 2-week repeated, and 13-week repeated oral dose toxicity studies were conducted in Sprague-Dawley rats. The dose levels of groups were 1,250, 2,500, and 5,000 mg/kg/d. All dose groups were compared with the vehicle control group. The animals were observed for clinical signs and weekly body weight. Urinalysis, hematology, and serum biochemistry analyses were conducted. Subsequently, animals were sacrificed and subjected to histopathological examination. For the result, NOAEL of ethanol extract from unripe fruit of bitter melon had an optimal dose of 5,000 mg/kg/d and acceptable daily intake up to 3,000 mg/man. There was no target organ detected. Therefore, bitter melon, which contains a variety of bioactive substances, could be widely used as a health functional food ingredient.

• The Journal of Korea Assosiation for Disability and Oral Health
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• v.5 no.1
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• pp.18-22
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• 2009

A 26-year-old female patient with Down syndrome visited to recieve dental treatment under gnenral anesthesia 6 years ago. The patient had difficulties in oral examination, radiograph taking and laboratory test. The patient had congenital heart disease and medical consultation based on the echocardiography was provided by a cardiologist indicating that the patient could tolearte general anesthesia during dental treatment. And two times of general anesthesia were administered during a dental treament with the interval of 3 years and no postoperpative complicaton was reported. At the third dental operation, the patient had a relatively good condition and her prescreening test revealed no abnormalities. Without further consultation with a cardiologist, general anesthesia was administered to the patient. Anaesthesia was based on thiopental and ventilation of desflurane and $N_2O$ in oxygen via an endotracheal tube with an appropriate monitoring. During the maintenance of anesthesia, the blood pressure of the patient started to drop and the oxygen saturation also began to decrease. Consequently, the proceding operation was discontinued and also inhalation anesthesia was ceased. As the patient was recovered from anesthesia, her systemic conditions were alleviated. After the complete recovery of the patient, she visited the cardiologist, and the cardiologic test revealed her severe right ventricular dilatation. In the anesthesia of patients with congenital heart disease, information on their systemic conditions needs to be undated from the medical consultation, which assures the safety of treatment.

• Smart Structures and Systems
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• v.24 no.5
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• pp.631-639
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• 2019

Finite element analysis is one of the important methods to study the structural performance. Due to the simplification, discretization and error of structural parameters, numerical model errors always exist. Besides, structural characteristics may also change because of material aging, structural damage, etc., making the initial finite element model cannot simulate the operational response of the structure accurately. Based on Bayesian methods, the initial model can be updated to obtain a more accurate numerical model. This paper presents the work on the field test, modal identification and model updating of a Chinese reinforced concrete pagoda. Based on the ambient vibration test, the acceleration response of the structure under operational environment was collected. The first six translational modes of the structure were identified by the enhanced frequency domain decomposition method. The initial finite element model of the pagoda was established, and the elastic modulus of columns, beams and slabs were selected as model parameters to be updated. Assuming the error between the measured mode and the calculated one follows a Gaussian distribution, the posterior probability density function (PDF) of the parameter to be updated is obtained and the uncertainty is quantitatively evaluated based on the Bayesian statistical theory and the Metropolis-Hastings algorithm, and then the optimal values of model parameters can be obtained. The results show that the difference between the calculated frequency of the finite element model and the measured one is reduced, and the modal correlation of the mode shape is improved. The updated numerical model can be used to evaluate the safety of the structure as a benchmark model for structural health monitoring (SHM).

• Journal of the Korean Society of Radiology
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• v.12 no.7
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• pp.887-893
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• 2018

The purpose of this study is to compare the performance of X-ray generators installed in hospitals and universities and apply the quality control items of diagnostic X-ray generators to recognize the importance of periodic performance management. First, the reproducibility and linearity test results showed that the PAE of the reproducibility evaluation was high for the GX-650 devices that met the acceptance criteria in all the experimental conditions and lacked the periodic quality control. In the linearity evaluation, when the tube voltage was set to 100 kVp, It was measured to deviate from the error. In addition, it was found that the PAE in the low-accuracy evaluation results relative to an X-ray tube voltage and tube current of the device low occurrence frequency. The HVL experiment was included in all of the devices at the HVL by tube voltage. Therefore, it is necessary to recognize the importance of quality control of all devices rather than hospital and laboratory, and to manage the device performance by actively managing the device, and to establish a short - term quality control system like special medical devices.

• Computers and Concrete
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• v.31 no.5
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• pp.457-468
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• 2023

Buildings, bridges, and dams are examples of civil infrastructure that play an important role in public life. These structures are prone to structural variations over time as a result of external forces that might disrupt the operation of the structures, cause structural integrity issues, and raise safety concerns for the occupants. Therefore, monitoring the state of a structure, also known as structural health monitoring (SHM), is essential. Owing to the emergence of the fourth industrial revolution, next-generation sensors, such as wireless sensors, UAVs, and video cameras, have recently been utilized to improve the quality and efficiency of building forensics. This study presents a method that uses a target-based system to estimate the dynamic displacement and its corresponding dynamic properties of structures using UAV-based video. A laboratory experiment was performed to verify the tracking technique using a shaking table to excite an SDOF specimen and comparing the results between a laser distance sensor, accelerometer, and fixed camera. Then a field test was conducted to validate the proposed framework. One target marker is placed on the specimen, and another marker is attached to the ground, which serves as a stationary reference to account for the undesired UAV movement. The results from the UAV and stationary camera displayed a root mean square (RMS) error of 2.02% for the displacement, and after post-processing the displacement data using an OMA method, the identified natural frequency and damping ratio showed significant accuracy and similarities. The findings illustrate the capabilities and reliabilities of the methodology using UAV to evaluate the dynamic properties of structures.

• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• The Journal of KAIRB
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• v.1 no.2
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• pp.30-42
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• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.