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A Study on the Countermeasures Taken By the Korean Healthcare and Life Sciences Industry Regarding U.S. Import Refusals: Focus on the Analysis of FDA Violation Codes (한국 바이오헬스 산업의 미국 수입거부 대응 방안 연구 : FDA 위반코드 분석을 중심으로)

  • Yu-Han Lee;Hag-Min Kim
    • Korea Trade Review
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    • v.48 no.3
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    • pp.131-150
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    • 2023
  • The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).

Overcoming taxonomic challenges in DNA barcoding for improvement of identification and preservation of clariid catfish species

  • Piangjai Chalermwong;Thitipong Panthum;Pish Wattanadilokcahtkun;Nattakan Ariyaraphong;Thanyapat Thong;Phanitada Srikampa;Worapong Singchat;Syed Farhan Ahmad;Kantika Noito;Ryan Rasoarahona;Artem Lisachov;Hina Ali;Ekaphan Kraichak;Narongrit Muangmai;Satid Chatchaiphan6;Kednapat Sriphairoj;Sittichai Hatachote;Aingorn Chaiyes;Chatchawan Jantasuriyarat;Visarut Chailertlit;Warong Suksavate;Jumaporn Sonongbua;Witsanu Srimai;Sunchai Payungporn;Kyudong Han;Agostinho Antunes;Prapansak Srisapoome;Akihiko Koga;Prateep Duengkae;Yoichi Matsuda;Uthairat Na-Nakorn;Kornsorn Srikulnath
    • Genomics & Informatics
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    • v.21 no.3
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    • pp.39.1-39.15
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    • 2023
  • DNA barcoding without assessing reliability and validity causes taxonomic errors of species identification, which is responsible for disruptions of their conservation and aquaculture industry. Although DNA barcoding facilitates molecular identification and phylogenetic analysis of species, its availability in clariid catfish lineage remains uncertain. In this study, DNA barcoding was developed and validated for clariid catfish. 2,970 barcode sequences from mitochondrial cytochrome c oxidase I (COI) and cytochrome b (Cytb) genes and D-loop sequences were analyzed for 37 clariid catfish species. The highest intraspecific nearest neighbor distances were 85.47%, 98.03%, and 89.10% for COI, Cytb, and D-loop sequences, respectively. This suggests that the Cytb gene is the most appropriate for identifying clariid catfish and can serve as a standard region for DNA barcoding. A positive barcoding gap between interspecific and intraspecific sequence divergence was observed in the Cytb dataset but not in the COI and D-loop datasets. Intraspecific variation was typically less than 4.4%, whereas interspecific variation was generally more than 66.9%. However, a species complex was detected in walking catfish and significant intraspecific sequence divergence was observed in North African catfish. These findings suggest the need to focus on developing a DNA barcoding system for classifying clariid catfish properly and to validate its efficacy for a wider range of clariid catfish. With an enriched database of multiple sequences from a target species and its genus, species identification can be more accurate and biodiversity assessment of the species can be facilitated.

Attenuation of Oxidative Stress-Induced HepG2 Cellular Damage by Cirsiumjaponicum Root Extract (HepG2 세포에서 대계 추출물에 의한 산화적 스트레스 유발 세포 손상의 억제)

  • Da Jung Ha;Seohwi Kim;Byunwoo Son;Myungho Jin;Sungwoo Cho;Sang Hoon Hong;Yung Hyun Choi;Sang Eun Park
    • Journal of Life Science
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    • v.33 no.12
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    • pp.1002-1014
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    • 2023
  • The root of Cirsium japonicum var. maackii (Maxim.) has long been used in traditional medicine to prevent the onset and progression of various diseases and has been reported to exert a wide range of physiological effects, including antioxidant activity. However, research on its effects on hepatocytes remains scarce. This study used the human hepatocellular carcinoma HepG2 cell line to investigate the antioxidant activity of ethanol extract of C. japonicum root (EECJ) on hepatocytes. Hydrogen peroxide (H2O2) was used to mimic oxidative stress. The results showed that EECJ significantly reverted the decrease in cell viability and suppressed the release of lactate dehydrogenase in HepG2 cells treated with H2O2. Moreover, an analysis of changes in cell morphology, flow cytometry, and microtubule-associated protein light chain 3 (LC3) expression showed that EECJ significantly inhibited HepG2 cell autophagy induced by H2O2. Furthermore, it attenuated H2O2-induced apoptosis and cell cycle disruption by blocking intracellular reactive oxygen species and mitochondrial superoxide production, indicating strong antioxidant activity. EECJ also restored the decreased levels of intracellular glutathione (GSH) and enhanced the expression and activity of superoxide dismutase and GSH peroxidase in H2O2-treated HepG2 cells. Although an analysis of the components contained in EECJ and in vivo validation using animal models are needed, these findings indicate that EECJ is a promising candidate for the prevention and treatment of oxidative stress-induced liver cell damage.

A Study on the Choice of Export Payment Types by Applying the Characteristics of the New Trade & Logistics Environment (신(新)무역물류환경의 특성을 적용한 수출대금 결제유형 선택연구)

  • Chang-bong Kim;Dong-jun Lee
    • Korea Trade Review
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    • v.48 no.4
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    • pp.303-320
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    • 2023
  • Recently, import and export companies have been using T/T remittance and Surrender B/L more frequently than L/C when selecting the process and method of trade payment settlement. The new trade and logistics environment is thriving in the era of the Fourth Industrial Revolution (4IR). Document-based trade transactions are undergoing a digitalization as bills of lading or smart contracts are being developed. The purpose of this study is to verify whether exporters choose export payment types based on negotiating factors. In addition, we would like to discuss the application of the characteristics of the new trade and logistics environment. Data for analysis was collected through surveys. The collection method consisted of direct visits to the company, e-mail, fax, and online surveys. The survey distribution period is from February 1, 2023, to April 30, 2023. The questionnaire was distributed in 2,000 copies, and 447 copies were collected. The final 336 copies were used for analysis, excluding 111 copies that were deemed inappropriate for the purpose of this study. The results of the study are shown below. First, among the negotiating factors, the product differentiation of exporters did not significantly affect the selection of export payment types. Second, among the negotiating factors, the greater the purchasing advantage recognized by exporters, the higher the possibility of using the post-transfer method. In addition to analyzing the results, this study suggests that exporters should consider adopting new payment methods, such as blockchain technology-based bills of lading and trade finance platforms, to adapt to the characteristics of the evolving trade and logistics environment. Therefore, exporters should continue to show interest in initiatives aimed at digitizing trade documents as a response to the challenges posed by bills of lading. In future studies, it is necessary to address the lack of social awareness in Korea by conducting advanced research abroad.

Development of a Simultaneous Analytical Method for Azocyclotin, Cyhexatin, and Fenbutatin Oxide Detection in Livestock Products using the LC-MS/MS (LC-MS/MS를 이용한 축산물 중 유기주석계 농약 Azocyclotin, Cyhexatin 및 Fenbutatin oxide의 동시시험법 개발)

  • Nam Young Kim;Eun-Ji Park;So-Ra Park;Jung Mi Lee;Yong Hyun Jung;Hae Jung Yoon
    • Journal of Food Hygiene and Safety
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    • v.38 no.5
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    • pp.361-372
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    • 2023
  • Organotin pesticide is used as an acaricide in agriculture and may contaminate livestock products. This study aims to develop a rapid and straightforward analytical method for detecting organotin pesticides, specifically azocyclotin, cyhexatin, and fenbutatin oxide, in various livestock products, including beef, pork, chicken, egg, and milk, using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The extraction process involved the use of 1% acetic acid in a mixture of acetonitrile and ethyl acetate (1:1). This was followed by the addition of anhydrous magnesium sulfate (MgSO4) and anhydrous sodium chloride. The extracts were subsequently purified using octadecyl (C18) and primary secondary amine (PSA), after which the supernatant was evaporated. Organotin pesticide recovery ranged from 75.7 to 115.3%, with a coefficient of variation (CV) below 25.3%. The results meet the criteria range of the Codex guidelines (CODEX CAC/GL 40). The analytical method in this study will be invaluable for the analysis of organotin pesticides in livestock products.

Factor influencing trust among Korean adolescents: Indigenous psychological analysis of relational trust (청소년기 신뢰의식의 형성과 집단별 차이 비교: 인간관계 신뢰에서의 토착심리를 중심으로)

  • Young-shin Park;Uichol Kim
    • Korean Journal of Culture and Social Issue
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    • v.12 no.3
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    • pp.85-127
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    • 2006
  • This study examines the formation and change of relational trust among Korean adolescents using indigenous psychological perspective. Among adolescents, we examine the basis of trust of their parents, friends and teacher and also their trust in people and institutions. A total of 968 adolescents (227 elementary, 284 middle school, 213 high school, and 244 university students) completed a questionnaire that contains the Relational Trust Scale developed by Kim and Park (2004a), Generalized Trust Scale developed by Yamagishi (1998) and a scale measuring trust of people and institutions (Kim, Helgesen & Ahn, 2002). The results are as follows. First, adolescents trust their parents due to their sacrifice, followed by their counsel and advice, dependability, consanguinity and respects. They trust their teachers due to their counsel and advice, followed by respect, sacrifice, and mutual trust. They trust their friends due to their advice, followed by empathy, mutual trust, dependability, friendship and sacrifice. Second, trust of their parents are highest among the elementary school students and lowest for the middle school students and lower for older age groups. The trust in teachers are highest among the elementary school students and lowest among the middle school and university students. In contrast, trust in friends increase from elementary school students to older age groups. Third, among trust in people and institutions, they are highest for parents and family and lowest for politicians and political parties. Except for trust in friends, trust of significant others and institutions (family, teachers, neighbors, company executives and politicians) is highest among the youngest age group and it decreases with older age group. Fourth, Yamagishi's generalized trust was highest among the older age groups (high school and university students). The patterns of results for relational trust and generalized trust is different and it points to the importance of understanding trust from the indigenous psychological perspective.

Seasonal Variation in Species Composition and Abundance of Shallow Water Fishes at Taean Beaches, in the Yellow Sea of Korea (태안 해빈 천해 어류 종조성의 계절 변화)

  • Noh, Hyung-Soo;Youk, Kwan-Su;Hwang, Hak-Bin;Lee, Tae-Won
    • The Sea:JOURNAL OF THE KOREAN SOCIETY OF OCEANOGRAPHY
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    • v.14 no.3
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    • pp.145-154
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    • 2009
  • Seasonal variation in species composition and abundance of shallow water fish from the Hakampo and Yeonpo beaches in Taean in the western coast of Korea were determined by the analysis of monthly samples collected by a beach seine from January to December, 2007. A total of 30 species, 964 individuals and 10,564.1 g of fish were collected from the Hakampo beach, and a total of 46 species, 4,447 individuals and 28,622.4 g of fish from the Yeonpo beach. The juveniles of coastal fish such as Chelon haematochelius, Paralichthys olivaceus, Repomucenus lunatus, Sebastes schlegelii and Takifugu niphobles were predominated in abundance. And the juveniles of pelagic migrants such as Konosirus punctatus, Sardinella zunasi and Engraulis japonicus were abundantly collected between summer and autumn. The fish collected were mainly composed of small-sized species and juveniles. C. haematochelius and migrant fish were young of the year, and commercially important fish such as S. schlegeli, P. olivaceus, Pleuronectes yokohamae and Hexagrammos otakii were 1 to 2 years old juveniles. It is considered that they use the shallow water as a nursery ground until they move out to the deeper water. The number of species and abundance were lower in the fine sand Hakamp beach than in the muddy sand Yeonpo beach where some Zostera marina were also found. In Yeonpo beach the adult of Gymnogobius mororanus preferred to live in the muddy shallow water and Syngnathus schlegeli living in the sea grass were also abundantly collected in spring in addition to resident fish and pelagic migrants in warm months. The resident species were more abundance in the Taean beach than in the beach located in the southern part of the west coast of Korea where the juveniles of pelagic migrants were more abundant.

Accuracy of HF radar-derived surface current data in the coastal waters off the Keum River estuary (금강하구 연안역에서 HF radar로 측정한 유속의 정확도)

  • Lee, S.H.;Moon, H.B.;Baek, H.Y.;Kim, C.S.;Son, Y.T.;Kwon, H.K.;Choi, B.J.
    • The Sea:JOURNAL OF THE KOREAN SOCIETY OF OCEANOGRAPHY
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    • v.13 no.1
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    • pp.42-55
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    • 2008
  • To evaluate the accuracy of currents measured by HF radar in the coastal sea off Keum River estuary, we compared the facing radial vectors of two HF radars, and HF radar-derived currents with in-situ measurement currents. Principal component analysis was used to extract regression line and RMS deviation in the comparison. When two facing radar's radial vectors at the mid-point of baseline are compared, RMS deviation is 4.4 cm/s in winter and 5.4 cm/s in summer. When GDOP(Geometric Dilution of Precision) effect is corrected from the RMS deviations that is analyzed from the comparison between HF radar-derived and current-metermeasured currents, the error of velocity combined by HF radar-derived current is less than 5.1 cm/s in the stations having moderate GDOP values. These two results obtained from different method suggest that the lower limit of HF radar-derived current's accuracy is 5.4 cm/s in our study area. As mentioned in previous researches, RMS deviations become large in the stations located near the islands and increase as a function of mean distance from the radar site due to decrease of signal-to-noise level and the intersect angle of radial vectors. We found that an uncertain error bound of HF radar-derived current can be produced from the separation process of RMS deviations using GDOP value if GDOP value for each component is very close and RMS deviations obtained from current component comparison are also close. When the current measured in the stations having moderate GDOP values is separated into tidal and subtidal current, characteristics of tidal current ellipses analyzed from HF radar-derived current show a good agreement with those from current-meter-measured current, and time variation of subtidal current showed a response reflecting physical process driven by wind and density field.

Survey of elementary school teachers' perceptions of the 2022 revised mathematics curriculum (2022 개정 수학과 교육과정에 대한 초등학교 교사들의 인식 조사)

  • Kwon, Jeom-rae
    • Education of Primary School Mathematics
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    • v.27 no.2
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    • pp.111-137
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    • 2024
  • The purpose of this study is to identify the expected difficulties and necessary support when applying the 2022 revised mathematics curriculum to elementary schools, and to support the establishment of the field. To this end, we explored the major changes in the 2022 revised mathematics curriculum, and based on this, we conducted a survey of elementary school teachers to identify the expected difficulties and necessary support when applying it in the field. In particular, when analyzing the results, we also examined whether there were any differences in the expected difficulties and necessary support depending on the size of the school where it is located and the teaching experience of the teacher. The research results are as follows. First, the proportion of teachers who expect difficulties in applying the 2022 revised mathematics curriculum was mostly below 50%, but the proportion of teachers who demand support was much higher, at around 80%. Second, the difficulty of elementary school teachers in applying the 2022 revised mathematics curriculum was found to be the greatest in evaluation. Third, in relation to the use of edutech, teachers in elementary schools are also expected to have difficulties in teaching and learning methods to foster students' digital literacy, assessment using teaching materials or engineering tools, and assessment in online environments. Fourth, the difficulty of elementary school teachers in applying the 2022 revised mathematics curriculum was also significant in relation to mathematics subject competencies. Fifth, it was found that there is also difficulty in understanding the major changes of the achievement standards, including the addition, deletion, and adjustment of the achievement standards, and the impact on the learning of other achievement standards. Finally, the responses of elementary school teachers to the expected difficulties and necessary support in applying the 2022 revised mathematics curriculum did not differ depending on the size of the school where it is located, but statistically significant differences were found in a number of items depending on the teaching experience of the teacher. Based on these research results, we hope that various support will be provided for the 2022 revised mathematics curriculum, which will be applied annually from 2024.

Analysis of the Effect of Corner Points and Image Resolution in a Mechanical Test Combining Digital Image Processing and Mesh-free Method (디지털 이미지 처리와 강형식 기반의 무요소법을 융합한 시험법의 모서리 점과 이미지 해상도의 영향 분석)

  • Junwon Park;Yeon-Suk Jeong;Young-Cheol Yoon
    • Journal of the Computational Structural Engineering Institute of Korea
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    • v.37 no.1
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    • pp.67-76
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    • 2024
  • In this paper, we present a DIP-MLS testing method that combines digital image processing with a rigid body-based MLS differencing approach to measure mechanical variables and analyze the impact of target location and image resolution. This method assesses the displacement of the target attached to the sample through digital image processing and allocates this displacement to the node displacement of the MLS differencing method, which solely employs nodes to calculate mechanical variables such as stress and strain of the studied object. We propose an effective method to measure the displacement of the target's center of gravity using digital image processing. The calculation of mechanical variables through the MLS differencing method, incorporating image-based target displacement, facilitates easy computation of mechanical variables at arbitrary positions without constraints from meshes or grids. This is achieved by acquiring the accurate displacement history of the test specimen and utilizing the displacement of tracking points with low rigidity. The developed testing method was validated by comparing the measurement results of the sensor with those of the DIP-MLS testing method in a three-point bending test of a rubber beam. Additionally, numerical analysis results simulated only by the MLS differencing method were compared, confirming that the developed method accurately reproduces the actual test and shows good agreement with numerical analysis results before significant deformation. Furthermore, we analyzed the effects of boundary points by applying 46 tracking points, including corner points, to the DIP-MLS testing method. This was compared with using only the internal points of the target, determining the optimal image resolution for this testing method. Through this, we demonstrated that the developed method efficiently addresses the limitations of direct experiments or existing mesh-based simulations. It also suggests that digitalization of the experimental-simulation process is achievable to a considerable extent.