• Title/Summary/Keyword: Korea and Canada

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Regulatory Requirements on the Safety and Efficacy Evaluation for the Development of Stereoisomeric Drugs (광학이성질체 의약품 개발에서 안전성과 유효성 평가에 대한 규제 요건)

  • Kim, Kwang-Joon;Choi, In;Seo, Kyu-Hwa;Han, Hyo-Kyung;Lee, Won-Jae
    • YAKHAK HOEJI
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    • v.55 no.5
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    • pp.426-431
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    • 2011
  • This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the development and approval of stereoisomeric drugs in US, EU, Canada and Japan. The important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substance 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. The regulatory documents adopted in major countries for the safety and efficacy evaluation of stereoisomeric drugs were investigated with the focus on three major categories mentioned above. For the regulatory approval of stereoisomeric drugs in Korea, it is expected that the investigated results obtained in this study will be useful for the basic materials to ensure the safety and efficacy of stereoisomeric drugs as well as the stereochemical issues in chiral drug development in domestic pharmaceutical company.

Trend on International Standardization Meeting of ISO/IEC JTC 1 Directives SWG (Special Working Group) (ISO/IEC JTC 1 Directives SWG 국제 표준화 회의 동향)

  • Park, Wung;Lee, Byoung-Nam
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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    • 2011.10a
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    • pp.571-574
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    • 2011
  • Special Working Group on Directives under ISO/IEC JTC 1 is responsible to maintain core documents describing basic procedural and drafting rules to be followed by JTC 1. The Directives SWG meeting was held from August 31 to September 2 in 2011 in Ottawa Canada. There were 24 participants from 7 countries in this meeting. This paper is to review the major results of the meeting and to suggest some strategic ways for future standardization activities in Korea.

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Impact of COVID-19 on the Stock Market Performance of Global IT Sector

  • CHAUDHARY, Rashmi;BAKHSHI, Priti
    • The Journal of Asian Finance, Economics and Business
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    • v.9 no.3
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    • pp.217-227
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    • 2022
  • Predicting return and volatility in the global Capital Market during a pandemic is challenging, and it is more difficult for a specific sector, particularly if that sector has a positive outlook. The goal of this research is to look at the impact of COVID-19 on the mean and volatility of the Information Technology Indexes of the best nine technology-driven countries based on return performance using an econometric GARCH model that is widely used. The daily returns of information technology indexes are evaluated for the same from November 2018 to February 2021. Data is taken from Yahoo Finance for CAC Tech (France), DAX Tech (Germany), FTSE All Tech (UK), KOPSI 200 IT (Korea), NIFTY IT (India), S&P 500 IT (US), S&P TSX (Canada), SSE_IT (China) and TOPIX17 (Japan). The results show daily positive mean returns for 8 countries' IT Indices and further, an uptrend in mean daily returns is observed in the crisis period for 6 countries' IT Indices. The exogenous variable COVID-19 which was taken as a regressor for the GARCH model was found to be positively significant for IT indices of all the countries. The overall results confirm the presence of the mean-reverting phenomenon for IT indices of all the countries.

Cellular and Molecular Roles of $\beta$ Cell Autoantigens, Macrophages and T Cells in the Pathogenesis of Automimmune Diabetes

  • Yoon, Ji-Won;Jun, Hee-Sook
    • Archives of Pharmacal Research
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    • v.22 no.5
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    • pp.437-447
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    • 1999
  • Type I diabetes, also known as insulin-dependent diabetes mellitus (IDDM) results from the destruction of insulin-producing pancreatic $\beta$ cells by a progressive $\beta$ cell-specific autoimmune process. The pathogenesis of autoimmune IDDM has been extensively studied for the past two decades using animal models such as the non-obese diabetic (NOD) mouse and the Bio-Breeding (BB) rat. However, the initial events that trigger the immune responses leading to the selective destruction of the $\beta$ cells are poorly understood. It is thought that $\beta$ cell auto-antigens are involved in the triggering of $\beta$ cell-specific autoimmunity. Among a dozen putative $\beta$ cell autoantigens, glutamic acid decarboxylase (GAD) has bee proposed as perhaps the strongest candidate in both humans and the NOD mouse. In the NOD mouse, GAD, as compared with other $\beta$ cell autoantigens, provokes the earliest T cell proliferative response. The suppression of GAD expression in the $\beta$ cells results in the prevention of autoimmune diabetes in NOD mice. In addition, the major populations of cells infiltrating the iselts during the early stage of insulitis in BB rats and NOD mice are macrophages and dendritic cells. The inactivation of macrophages in NOD mice results in the prevention of T cell mediated autoimmune diabetes. Macrophages are primary contributors to the creation of the immune environment conducive to the development and activation of $\beta$cell-specific Th1-type CD4+ T cells and CD8+ cytotoxic T cells that cause autoimmune diabetes in NOD mice. CD4+ and CD8+ T cells are both believed to be important for the destruction of $\beta$ cells. These cells, as final effectors, can kill the insulin-producing $\beta$ cells by the induction of apoptosis. In addition, CD8+ cytotoxic T cells release granzyme and cytolysin (perforin), which are also toxic to $\beta$ cells. In this way, macrophages, CD4+ T cells and CD8+ T cells act synergistically to kill the $\beta$ cells in conjunction with $\beta$ cell autoantigens and MHC class I and II antigens, resulting in the onset of autoimmune type I diabetes.

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Review on Soil Erosion and Loss Management System of the Calgary City Government, Albert, Canada (캐나다 앨버트 주 캘거리 시의 토사관리제도에 관한 고찰)

  • Kim, Youngchul;Kim, Lee-Hyung;Hwang, Sung Woo
    • Journal of Wetlands Research
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    • v.17 no.2
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    • pp.163-175
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    • 2015
  • In this paper, soil erosion and soil loss management system (SMS) of the City of Calgary in Albert, Canada was reviewed. Regulatory basis supporting this soil management system, permit process and conditions, guidelines and principles for the SMS, and monitoring and repair duties, inspection were discussed. Permit process in the City of Calgary is handled mainly by Urban Development Division, in which special task force called CPAG (Coorporative Planning Application Group) (if necessary circulated through related subdivisions). Inspects all the permit conditions and decides permit or refusal, and LUM (Land Use and Mobility) advertises the approval, if there is no appeals, permit is released to developers. If permit is rejected, applicant can appeals Development Appeal Board, it can approve or reject. In addition to permit, the city has manual for soil management plan, which includes BMP selection, design, monitoring, maintenance, and inspection activities. Perfect SMS policy does not necessarily guarantee relieving the soil-particle related pollution problem, but in Korea, we have to recognize that construction works during development is potentially the most destructive stage of environmental pollution. The central and local governments must make preparations for the effective and tight regulations and ordinance which is appropriate for regional social-economic conditions.

A Study on Development and Status of Educating Culture Content Specialists - Focusing on Domestic and Foreign Educational Organization Cases - (문화콘텐츠의 전문 인력 양성 현황 및 발전에 대한 연구 - 국내외 문화콘텐츠 교육기관 사례 비교를 중심으로 -)

  • Kim, Tae-Hyun;Jo, Ha-Na;Choi, Hun
    • Proceedings of the Korea Contents Association Conference
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    • 2007.11a
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    • pp.672-676
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    • 2007
  • Although research interests on culture content have been increased in recent years, few studies have focused on the educating culture content specialists. The purpose of this study is to investigate point of issue based on the domestic and foreign organization cases which are related to culture content. To achieve our purpose, this study showed educating culture content specialists of foreign organization cases especially, USA, Japan, England, Australia, and Canada. In addition, we propose educating culture content specialists of domestic organization especially, university. With foreign and domestic cases of educating culture content specialists, we suggest few recommendations for development culture contents. This paper concludes with study point of issue as well as recommendations.

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Atmospheric Chemistry of Mercury in the Polar Regions and its Environmental Implications (극지환경 수은의 대기화학과 환경학적 의미)

  • Schroeder, WH;Kim, Min-Young;Hong, Sung-Min;Shon, Zang-Ho;Kim, Ki-Hyun
    • Journal of the Korean earth science society
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    • v.24 no.5
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    • pp.420-427
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    • 2003
  • The results of recent studies indicate that atmospheric distribution of Hg in the arctic environment is unique enough to show strong depletion during spring followed by notable increases during summer. The observations of this abnormal trend contrast quite sharply with what had been recognized as Hg geochemical behavior in air over the past decades. Using the long-term measurement data of Hg obtained from both the Arctic and Korea, we attempted to provide valuable insights into the unique mercury depletion phenomenon (MDP) in the polar regions of the globe.

Integrity Evaluation System of CANDU Reactor Pressure Tube

  • Kim, Young-Jin;Kwak, Sang-Log;Lee, Joon-Seong;Park, Youn-Won
    • Journal of Mechanical Science and Technology
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    • v.17 no.7
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    • pp.947-957
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    • 2003
  • The pressure tube is a major component of the CANDU reactor, which supports nuclear fuel bundle. In order to complete the integrity evaluation of pressure tube, expert knowledge, iterative calculation procedures and a lot of input data are required. More over, results of integrity assessment may be different according to the evaluation method. For this reason, an integrity evaluation system, which provides efficient way of evaluation with the help of attached database, was developed. The present system was built on the basis of 3D FEM results, ASME Sec. XI, and Fitness For Service Guidelines for CANDU pressure tubes issued by the AECL (Atomic Energy Canada Limited). The present system also covers the delayed hydride cracking and the blister evaluation, which are the characteristics of pressure tube integrity evaluation. In order to verify the present system, several case studies have been performed and the results were compared with those from AECL. A good agreement was observed between those two results.

Analysis of Gamma Radiation Fields in the MAPLE-X10 Facility Associated with Loss-of-Pool-Water Accident Conditions (LOSS-OF-POOL-WATER 사고시 연구용 원자로 MAPLE-X10 시설에서의 감마 방사선장 해석)

  • Kim, Kyo-Youn;Ha, Chung-Woo;I.C. Gauld
    • Nuclear Engineering and Technology
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    • v.21 no.2
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    • pp.63-72
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    • 1989
  • An analysis for the gamma radiation fields in the research reactor MAPLE-X10 facility has been peformed under the assumption of partial loss of reactor and service pool water to assess the safety from the view point of design. Four photon source terms considered in the analysis were calculated using the ORIGEN-S code. Gamma dose rate calculations over the reactor and service pools during the water-loss accident conditions were performed using QAD-CG code. MCNP code (Monte Carlo Neuron and Photon Transport code), also, was used to assess the scattered radiation fields away from the pools, which is appropriate for calculating the scattered photon dose rates outside of the solid angle subtended by the source and pool walls.

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Multi-unit risk assessment of nuclear power plants: Current status and issues

  • Yang, Joon-Eon
    • Nuclear Engineering and Technology
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    • v.50 no.8
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    • pp.1199-1209
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    • 2018
  • After the Fukushima-Daiichi accident in 2011, the multi-unit risk, i.e., the risk due to several nuclear power plants (NPPs) in a site has become an important issue in several countries such as Korea, Canada, and China. However, the multi-unit risk has been discussed for a long time in the nuclear community before the Fukushima-Daiichi nuclear accident occurred. The regulatory authorities around the world and the international organizations had proposed requirements or guidelines to reduce the multi-unit risk. The concerns regarding the multi-unit risk can be summarized in the following three questions: How much the accident of an NPP in a site affects the safety of other NPPs in the same site? What is the total risk of a site with many NPPs? Will the risk of the simultaneous accidents at several NPPs in a site such as the Fukushima Daiichi accident be low enough? The multi-unit risk assessment (MURA) in an integrated framework is a practical approach to obtain the answers for the above questions. Even though there were few studies to assess the multi-unit risk before the Fukushima-Daiichi nuclear accident, there are still several issues to be resolved to perform the complete MURA. This article aims to provide an overview of the multi-unit risk issues and its assessment. We discuss the several critical issues in the current MURA to get useful insights regarding the multi-unit risk with the current state art of probabilistic safety assessment (PSA) technologies. Also, the qualitative answers for the above questions are addressed.