• 제목/요약/키워드: Regulatory standard

검색결과 251건 처리시간 0.027초

수도권 미래 도시성장이 오존농도 변화에 미치는 영향 연구 (Study on the Effects of Future Urban Growth on Surface Ozone Concentrations in the Seoul Metropolitan Region)

  • 석현배;정주희;강윤희;김현수;김유근
    • 한국환경과학회지
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    • 제24권1호
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    • pp.31-46
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    • 2015
  • In this study, the regional climate (WRF) and air quality (CMAQ) models were used to simulate the effects of future urban growth on surface ozone concentrations in the Seoul metropolitan region (SMR). These analyses were performed based on changes in ozone concentrations during ozone seasons (May-June) for the year 2050 (future) relative to 2012 (present) by urban growth. The results were compared with the impacts of RCP scenarios on ozone concentrations in the SMR. The fractions of urban in the SMR (25.8 %) for the 2050 were much higher than those (13.9 %) for the 2012 and the future emissions (e.g., CO, NO, $NO_2$, $SO_2$, VOC) were increased from 121 % (NO) to 161.3 % ($NO_2$) depending on emission material. The mean and daily maximum 1-h ozone in the SMR increased about 3 - 7 ppb by the effect the RCP scenarios. However, the effect of urban growth reduced the mean ozone by 3 ppb in the SMR and increased the daily maximum 1-h ozone by 2 - 5 ppb over the northeastern SMR and around the coastline. In particular, the ozone pollution days exceeding the 1-h regulatory standard (100 ppb) were far more affected by urban growth than mean values. As a result, the average number of days exceeding the 1-h regulatory standard increased up to 10 times.

Essential Guidelines for Manufacturing and Application of Organoids

  • Sun-Ju Ahn;Sungin Lee;Dayeon Kwon;Sejeong Oh;Chihye Park;Sooyeon Jeon;Jin Hee Lee;Tae Sung Kim;Il Ung Oh
    • International Journal of Stem Cells
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    • 제17권2호
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    • pp.102-112
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    • 2024
  • An organoid is a self-organized three-dimensional structure derived from stem cells that mimics the structure, cell composition, and functional characteristics of specific organs and tissues and is used for evaluating the safety and effectiveness of drugs and the toxicity of industrial chemicals. Organoid technology is a new methodology that could replace testing on animals testing and accelerate development of precision and regenerative medicine. However, large variations in production can occur between laboratories with low reproducibility of the production process and no internationally agreed standards for quality evaluation factors at endpoints. To overcome these barriers that hinder the regulatory acceptance and commercialization of organoids, Korea established the Organoid Standards Initiative in September 2023 with various stakeholders, including industry, academia, regulatory agencies, and standard development experts, through public and private partnerships. This developed general guidelines for organoid manufacturing and quality evaluation and for quality evaluation guidelines for organoid-specific manufacturing for the liver, intestines, and heart through extensive evidence analysis and consensus among experts. This report is based on the common standard guideline v1.0, which is a general organoid manufacturing and quality evaluation to promote the practical use of organoids. This guideline does not focus on specific organoids or specific contexts of use but provides guidance to organoid makers and users on materials, procedures, and essential quality assessment methods at end points that are essential for organoid production applicable at the current technology level.

AN ANALYSIS OF TECHNICAL SECURITY CONTROL REQUIREMENTS FOR DIGITAL I&C SYSTEMS IN NUCLEAR POWER PLANTS

  • Song, Jae-Gu;Lee, Jung-Woon;Park, Gee-Yong;Kwon, Kee-Choon;Lee, Dong-Young;Lee, Cheol-Kwon
    • Nuclear Engineering and Technology
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    • 제45권5호
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    • pp.637-652
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    • 2013
  • Instrumentation and control systems in nuclear power plants have been digitalized for the purpose of maintenance and precise operation. This digitalization, however, brings out issues related to cyber security. In the most recent past, international standard organizations, regulatory institutes, and research institutes have performed a number of studies addressing these systems cyber security.. In order to provide information helpful to the system designers in their application of cyber security for the systems, this paper presents methods and considerations to define attack vectors in a target system, to review and select the requirements in the Regulatory Guide 5.71, and to integrate the results to identify applicable technical security control requirements. In this study, attack vectors are analyzed through the vulnerability analyses and penetration tests with a simplified safety system, and the elements of critical digital assets acting as attack vectors are identified. Among the security control requirements listed in Appendices B and C to Regulatory Guide 5.71, those that should be implemented into the systems are selected and classified in groups of technical security control requirements using the results of the attack vector analysis. For the attack vector elements of critical digital assets, all the technical security control requirements are evaluated to determine whether they are applicable and effective, and considerations in this evaluation are also discussed. The technical security control requirements in three important categories of access control, monitoring and logging, and encryption are derived and grouped according to the elements of attack vectors as results for the sample safety system.

Ribavirin Does Not Impair the Suppressive Activity of $Foxp3^+$ $ CD4^+$ $CD25^+$ Regulatory T Cells

  • Lee, Jeewon;Choi, Yoon Seok;Shin, Eui-Cheol
    • IMMUNE NETWORK
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    • 제13권1호
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    • pp.25-29
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    • 2013
  • Ribavirin is an antiviral drug used in combination with pegylated interferon-${\alpha}$ (IFN-${\alpha}$) for the treatment of hepatitis C virus (HCV) infection. Recently, ribavirin was reported to inhibit the suppressive activity of regulatory T (Treg) cells. In the present study, we re-evaluated the effect of ribavirin on $CD4^+$ $CD4^+$ $CD25^+$ Treg cells from normal donors. First, we examined the expression of CTLA-4 and CD39, which are known to play a role in the suppressive function of Treg cells. We found that ribavirin treatment did not modulate the expression of CTLA-4 and CD39 in Treg cells. We also studied the effect of ribavirin on Treg cells in the presence of IFN-${\alpha}$; however, the expression of CTLA-4 and CD39 in Treg cells was not changed by ribavirin in the presence of IFN-${\alpha}$. Next, we directly evaluated the effect of ribavirin on the suppressive activity of Treg cells in the standard Treg suppression assay, by co-culturing CFSE-labeled non-Treg $CD4^+$ T cells with purified Treg cells. We found that ribavirin did not attenuate the suppressive activity of Treg cells. Taken together, while ribavirin reversed Treg cell-mediated suppression of effector T cells in the previous study, we herein demonstrate that ribavirin does not impair the suppressive activity of Treg cells.

Respirable Silica Dust Exposure of Migrant Workers Informing Regulatory Intervention in Engineered Stone Fabrication

  • Mahinda Seneviratne;Kiran Shankar;Phillip Cantrell;Aklesh Nand
    • Safety and Health at Work
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    • 제15권1호
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    • pp.96-101
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    • 2024
  • Background: Silicosis among workers who fabricate engineered stone products in micro or small-sized enterprises (MSEs) was reported from several countries. Workplace exposure data of these workers at high risk of exposure to respirable crystalline silica (RCS) dust are limited. Methods: We surveyed workers performing cutting, shaping and polishing tasks at 6 engineered stone fabricating MSEs in Sydney, Australia prior to regulatory intervention. Personal exposure to airborne RCS dust in 34 workers was measured, work practices were observed using a checklist and worker demography recorded. Results: Personal respirable dust measurements showed exposures above the Australian workplace exposure standard (WES) of 0.1 mg/m3 TWA-8 hours for RCS in 85% of workers who performed dry tasks and amongst 71% using water-fed tools. Dust exposure controls were inadequate with ineffective ventilation and inappropriate respiratory protection. All 34 workers sampled were identified as overseas-born migrants, mostly from three linguistic groups. Conclusions: Workplace exposure data from this survey showed that workers in engineered stone fabricating MSEs were exposed to RCS dust levels which may be associated with a high risk of developing silicosis. The survey findings were useful to inform a comprehensive regulatory intervention program involving diverse hazard communication tools and enforcing improved exposure controls. We conclude that modest occupational hygiene surveys in MSEs, with attention to workers' demographic factors can influence the effectiveness of intervention programs. Occupational health practitioners should address these potential determinants of hazardous exposures in their workplace surveys to prevent illness such as silicosis in vulnerable workers.

Detection of Malignant Primary Hepatic Neoplasms with Gadobenate Dimeglumine (Gd-BOPTA) Enhanced T1-Weighted Hepatocyte Phase MR Imaging: Results of Off-site Blinded Review in a Phase-II Multicenter Trial

  • Constantino S. Pena;Sanjay Saini;Richard L. Baron;Bernd A. Hamm;Giovanni Morana;Roberto Caudana;Andrea Giovagnoni;Andrea Villa;Alessandro Carriero;Didier Mathieu;Michael W. Bourne;Miles A. Kirchin;Gianpaolo Pirovano;Alberto Spinazzi
    • Korean Journal of Radiology
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    • 제2권4호
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    • pp.210-215
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    • 2001
  • Objective: To investigate the efficacy of gadobenate dimeglumine (GdBOPTA) enhanced MR imaging for the detection of liver lesions in patients with primary malignant hepatic neoplasms. Materials and Methods: Thirty-one patients with histologically proven primary malignancy of the liver were evaluated before and after administration of GdBOPTA at dose 0.05 or 0.10 mmol/kg. T1-weighted spin echo (T1W-SE) and gradient echo (T1W-GRE) images were evaluated for lesion number, location, size and confidence by three off-site independent reviewers and the findings were compared to reference standard imaging (intraoperative ultrasound, computed tomography during arterial portography or lipiodol computed tomography). Results were analyzed for significance using a two-sided McNemar's test. Results: More lesions were identified on Gd-BOPTA enhanced images than on unenhanced images and there was no significant difference in lesion detection between either concentration. The largest benefit was in detection of lesions under 1 cm in size (7 to 21, 9 to 15, 16 to 18 for reviewers A, B, C respectively). In 68% of the patients with more than one lesion, Gd-BOPTA increased the number of lesions detected. Conclusion: Liver MR imaging after Gd-BOPTA increases the detection of liver lesions in patients with primary malignant hepatic neoplasm.

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ICH-GCP와 선진 각국의 GCP 비교 (Comparison of Current GCPs on the Basis of the Contents in ICH-GCP)

  • 박혜연
    • 한국응용약물학회:학술대회논문집
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    • 한국응용약물학회 1997년도 추계학술대회
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    • pp.57-74
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    • 1997
  • To make a proposal for the revision of KGCP, ICH Harmonized Tripartite Guideline for Good Clinical Practice, which is on the stage of worldwide implementation, was compared with current GCPs of tripartite countries of ICH, namely USA, Europe and Japan as well as Korea. On the basis of the classification in ICH GCP, comprehensive comparisons among the corresponding articles of 4 regions or countries were made in the order of IRB / IEC, Investigator, Sponsor and Clinical Trial Protocol. Based on the comparisons of the contents in ICH-GCP with those in current GCPs, major suggestions for the revision of current KGCP can be made as follows. Firstly, the function of IRB / IEC needs to be strengthened for the initiation and continuation of clinical trial. Current 2-step approval system of IRB / IEC and Health Authorities requires to be converted into the system similar to that of developed countries. Secondly, sponsor's obligation needs to be tightened to control and assure the quality of clinical trial. Inspection of regulatory authorities should be made to perform during and / or after clinical trial, when it is necessary. In other words, sponsor should be made to establish written Standard Operating Procedures (SOPs) for all aspects of clinical trial including monitoring to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement (s). Besides, the provision of ‘Quality Control and Quality Assurance’ should be added to the protocol to establish the credibility of the result of the clinical trial.

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원자력 규제정책에 대한 국민신뢰도 평가 SD모델 연구 (System Dynamic Model Study of Public Trust on Nuclear Regulation Policy)

  • 곽미애;차현주;김성현;정관용
    • 한국시스템다이내믹스연구
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    • 제16권1호
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    • pp.53-74
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    • 2015
  • The purpose of this paper is to simulate public trust on nuclear regulation policy. The first of all, public trust variables and the model were developed and analysed by system dynamic method. The model are consisted of the operator safety culture level, regulatory competence levels, the public satisfaction and public trust level. The scenario is made up three type which base scenario, the system operator's safety culture level and accident event level. First. the simulation results of standard scenario shows that rapidly declining public satisfaction and trust level of the national safety after Japan's nuclear accident in November 2011. Second, operator safety culture level and simulated divided into three levels. The results showed that a greater impact on the public satisfaction if bad than good case. Finally, the size of the accident was simulated divided into three levels levels(no accident, medium, serious accidents). the results showed a weak effect against the regulatory capacity and safety performance levels but showed a significant impact on public satisfaction and confidence level.

고진등수 영역이 보강된 APR1400 설계지반응답스펙트럼의 개발 (Development of the DGRS enriched in the high frequency range for APR1400)

  • 장영선;김태영;주광호;김종학
    • 한국지진공학회:학술대회논문집
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    • 한국지진공학회 2001년도 추계 학술발표회 논문집 Proceedings of EESK Conference-Fall 2001
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    • pp.67-74
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    • 2001
  • This paper presents the Safe Shutdown Earthquake(SSE) input motion for the seismic design of the Advanced Power Reactor 1400(APR1400). The Design Ground Response Spectra(DGRS) far the SSE is based on the design spectrum specified in regulatory Guide(RG) 1.60 of U.S. Nuclear Regulatory Commission(US NRC), anchored to a Peak Ground Acceleration(PGA) of 0.3g and enriched in the high frequency range. This SSE seismic input motion is to be applied to the seismic analysis as the free-field seismic motion at the ground surface of both the rock and generic soil sites fur APRI1400. The enrichment for APR1400 seismic input motion is performed considering the current US NRC regulations, the seismic hazard studies performed by the Lawrence Livermore National Laboratory (LINL) and Electric Power Research Institute(EPRI) for the Central and Eastern United States nuclear power plant sites, and the seismic input motions used in the design certifications of the three existing U.S. advanced standard plants. It is represented by a set of DGRS and the accompanying Target Power Spectral Density(PSD) Function in both the horizontal and vertical directions.

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Fair Competition: The Concept of Regulation in the Sharing Economy

  • FAJAR, Mukti
    • The Journal of Asian Finance, Economics and Business
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    • 제7권11호
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    • pp.637-645
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    • 2020
  • A free-market economic system supported by the progress of the Industrial Revolution 4.0 has given birth to a sharing economy with a disruptive business model. In many ways, this business model is more effective, efficient, and makes it easy for businesses and consumers. However, because disruptive innovation is not asymmetrical with the conventional business that sustains innovation, several regulatory issues arise because it is fundamentally very different and cannot be regulated by standard law. Disruptive innovation may create chaos if it is regulated by norms that are used to regulate conventional business. This research was conducted with a normative method, which examines various theories, principles, laws and regulations to get justification for how the law should govern. The findings of this study are: competition law must be designed pragmatically so that it can keep pace with changes in business models that are rapidly changing. For this reason, it is necessary to shift regulatory authority from the Government to business people to make self-regulation, as a rule, that was born from the agreement of the business actors themselves. Self-regulation is considered more effective in maintaining fair competition, so that the market will be more dynamic, and consumers will be more prosperous.