• The Journal of Health Technology Assessment
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• v.1 no.1
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• pp.22-26
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• 2013

Objectives: Balancing benefits and risks through the drug life cycle has been discussed for many decades. The objective of this study was to review the processes and tools currently proposed for benefit-risk assessment of medicinal drugs. It aimed to establish scientific and efficient drug safety management system based on the synthetic analysis of benefit-risk evidence. Methods: We conducted a review of exiting literatures published by regulatory agencies or initiatives. Not only quantitative methodologies but also qualitative method were compared to understand their key characteristics for the benefit and risk assessment of drugs. Results: Recently, benefit-risk assessments have more structured approaches to decision making as part of regulatory science. Regulatory agencies such as European Medicines Agency, FDA have prepared plans to apply benefit-risk assessment to regulatory decision making. Also many initiatives such as IMI (Innovative Medicine Initiative) have conducted research and published reports about benefit-risk assessment. For benefit-risk assessment, four kinds of methods are necessary. Frameworks such as BRAT (Benefit Risk Action Team) framework, PrOACT-URL provide guidance for the whole process of decision-making. Metrics are measurements of risk benefit. The estimation techniques are methods to synthesis and combine evidences from various sources. The utility survey techniques are necessary to explicit preferences of various outcome from stakeholders. Conclusion: There is the lack of widely accepted, validated model for benefit-risk assessment. Nor there is an agreement among academia, industry, and government on methods for the quantitative valuation. It is also limited by available evidence and underlying assumptions. Nevertheless, benefit-risk assessment is fundamental to improve transparency, consistency and predictability for decision making through the structured systematic approaches.

• Structural Engineering and Mechanics
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• v.31 no.1
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• pp.11-24
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• 2009

In China, the oil and natural gas resources of Bohai Bay are mainly marginal oil fields. It is necessary to build both ice-resistant and economical offshore platforms. However, risk is involved in the design, construction, utilization, maintenance of offshore platforms as uncertain events may occur within the life-cycle of a platform under the extreme ice load. In this study, the optimum design model of the expected life-cycle cost for ice-resistant platforms based on cost-effectiveness criterion is proposed. Multiple performance demands of the structure, facilities and crew members, associated with the failure assessment criteria and evaluation functions of costs of construction, consequences of structural failure modes including damage, revenue loss, death and injury as well as discounting cost over time are considered. An efficient approximate method of the global reliability analysis for the offshore platforms is provided, which converts the implicit nonlinear performance function in the conventional reliability analysis to linear explicit one. The proposed life-cycle optimum design formula are applied to a typical ice-resistant platform in Bohai Bay, and the results demonstrate that the life-cycle cost-effective optimum design model is more rational compared to the conventional design.

• Journal of Korea Society of Industrial Information Systems
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• v.17 no.6
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• pp.73-82
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• 2012

This paper reviews Privacy Impact Assessments in order to perform preventing and diagnosis against potential threats focused on the C-Shopping mall case. The quality of protection in C-shopping mall shows that the corporations itself is 29.2, the system is 68.8, the life cycle of the privacy is 25.5 and CCTV is 60.0. The lowest levels are the corporation's management 16.7, the life-cycle's saving and keeping 12.5, usage and offer 11.5 and destruction 16.7 among the life cycle of the privacy. The result of risk analysis shows that the highest levels are saving and keeping 13.3 and destruction 13.0. From the result, dangerous duplications are saving and keeping and destructions.

• Journal of the Korean Society of Industry Convergence
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• v.23 no.4_2
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• pp.569-581
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• 2020

Since the dehydration packages of offshore plant deal directly with oil & gas, there is a great risk of fire and explosion during operation. Therefore, this study performed risk assessment through HAZard & OPerability (HAZOP) for solid desiccant dehydration package that can remove water component of natural gas in offshore floating liquefied natural gas (LNG) production facilities below 0.1 ppmv. The risk matrix was determined by dividing the likelihood and the severity into five levels separately by asset, life, environment and reputation. The piping & instrumentation diagram (P&ID) of the dehydration package was divided into 9 nodes. Total 22 deviations were assessed in consideration of the adsorption and desorption conversion cycle. A risk assessment based on deviations revealed 14 major hazards. Three representative types of hazards were open/close failure of the control valve, control failure of the heater, and abnormal operation of the regeneration gas cooler. Finally, we proposed the installation of additional safety devices to improve safety against these major hazards, such as safety instrumented functions, alarms, etc.

• Journal of Environmental Impact Assessment
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• v.14 no.2
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• pp.83-96
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• 2005

Brominated flame retardants have the market share of 40%, comparing others because of their low cost and highly effective retardation against the flame. However, their toxic effects in human and properties of the accumulation in the environments have been issued among the international organization such as EU, OECD and etc. It, therefore, was surveyed the classification, toxic effects, and the usage of Brominated flame retardants, the trends for their managements in the world and Korea, and their contaminated levels in Korean Peninsula. In addition, the management directions for them were proposed. Penta, octa, and deca-BDE among brominated retardants will seem to be prohibited by the regulation as a flame retardants for plastics in Europe because of their toxic effects. Although Penta and Octa BDEs was used marginally in Korea, deca-BDE was 27% of brominated flame retardants (49,050 ton) which had been used in 2002. However, risk assessment for brominated retardants might not launched in Korea, yet. These reports demonstrate that toxic brominated retardants such as PBDEs will be assessed for their usage and the level of contamination in the environment in the area of the point sources like the industrial areas, incinerators and etc. However, the law to regulate the hazardous chemicals seems not to be dictated the monitoring of their contamination in the environment. We, therefore, suggest how to evaluate and to monitor the toxic contaminants with EIA (Environmental Impact Assessment) and LCA (Life Cycle Assessment) system. Further, to establish the management system of BFRs (such as the monitering of contamination levels in environments, life cycle assessment, and risk assessment for the toxic chemicals), It can be recommended the law to deal with the method analyzing chemicals will be established, which contains QA/QC (Quality Assurance and Quality Control) to evaluate the analytic capability of the companies to prepare EIS (Environment Impact Statement) or other institutes for analyzing chemicals.

• Journal of Digital Convergence
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• v.10 no.8
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• pp.149-157
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• 2012

Recently, many corporations and public institutions are busy preparing and providing measures in dealing with new privacy information law. This study reviews privacy impact assessments in order to perform preventing and diagnosis against potential threats focus on the K-hospital case. The quality of protection in K-hospital shows that the corporations itself is 79.0, the system is 97.0, the life cycle of the privacy is 67.4 and CCTV is 90.0. The lowest levels are saving and keeping 50.0, usage and offer 64.1 and destruction 66.7 among the life cycle of the privacy. The result of risk analysis shows that the highest levels are controlling for privacy 11.0, saving and keeping 12.5 and destruction 13.0. From the result, dangerous duplications are saving and keeping and destructions.

• Journal of the Earthquake Engineering Society of Korea
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• v.20 no.7_spc
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• pp.485-494
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• 2016

The risk-based assessment, also called time-based assessment of structure is usually performed to provide seismic risk evaluation of a target structure for its entire life-cycle, e.g. 50 years. The prediction of collapse probability is the estimator in the risk-based assessment. While the risk-based assessment is the key in the performance-based earthquake engineering, its application is very limited because this evaluation method is very expensive in terms of simulation and computational efforts. So the evaluation database for many archetype structures usually serve as representative of the specific system. However, there is no such an assessment performed for building stocks in Korea. Consequently, the performance objective of current building code, KBC is not clear at least in a quantitative way. This shortcoming gives an unresolved issue to insurance industry, socio-economic impact, seismic safety policy in national and local governments. In this study, we evaluate the comprehensive seismic performance of an low-rise residential buildings with discontinuous structural walls, so called piloti-type structure which is commonly found in low-rise domestic building stocks. The collapse probability is obtained using the risk integral of a conditioned collapse capacity function and regression of current hazard curve. Based on this approach it is expected to provide a robust tool to seismic safety policy as well as seismic risk analysis such as Probable Maximum Loss (PML) commonly used in the insurance industry.

• Smart Structures and Systems
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• v.9 no.1
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• pp.1-20
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• 2012

In bridge engineering, maintenance strategies and thus budgetary demands are highly influenced by construction type and quality of design. Nowadays bridge owners and planners tend to include life-cycle cost analyses in their decision processes regarding the overall design trying to optimize structural reliability and durability within financial constraints. Smart permanent and short term monitoring can reduce the associated risk of new design concepts by observing the performance of structural components during prescribed time periods. The objectives of this paper are the discussion and analysis of influence line or influence field approaches in terms of (a) an efficient incorporation of monitoring information in the structural performance assessment, (b) an efficient characterization of performance indicators for the assessment of structures, (c) the ability of optimizing the positions of sensors of a monitoring system, and (d) the ability of checking the robustness of the monitoring systems applied to a structure. The proposed influence line- model correction approach has been applied to an integrative monitoring system that has been installed for the performance assessment of an existing three-span jointless bridge.

• Journal of the Korean Society of Safety
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• v.35 no.6
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• pp.78-84
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• 2020

The F&EI technique is one of the risk assessments with many advantages. It can save time and effort compared to quantitative risk assessment (QRA). By using the evaluation result of this technique, it is possible to check the effectiveness of the investment cost. In addition, a relative risk ranking can be created and used to establish the facility management cycle and to prioritize investment. However, evaluating the target process can be evaluated more than the actual risk since the LCCF, a loss prevention measure, is too limited. In addition, calculating premiums via this method can result in excessive premiums, making it difficult to evaluate the risk precisely. Therefore, new safety guard was added to the LCCF of the F&EI risk assessment with reference to HAZOP and LOPA techniques. Newly added LCCFs are Deflagration arrester, Check valve, SIS, and Vacuum beaker, etc. As a case study, F&EI risk assessment was performed on Acetone storage tank of a API (Active pharmaceutical ingredient) plant to compare actual MPPD. The estimated loss amount was 592,558$ for the existing technique and 563,571$ for the improved technique, which was reduced by about 5% compared to the previous one.This proved that a more precise evaluation is possible and that the efforts for safety at the workplace are reflected in the evaluation results.

• Fisheries and Aquatic Sciences
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• v.18 no.2
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• pp.183-193
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• 2015

Several transgenic marine medaka Oryzias dancena strains harboring a green fluorescent protein (GFP) reporter construct regulated by an endogenous ${\beta}$-actin promoter were established and their expression characteristics in relation to transgene copy numbers were examined in 21 transgene genotypes. Most of the transgenic strains displayed transgene insertion patterns typical of microinjection-mediated introduction of foreign DNA into fish embryos, characterized by the random integration of multiple transgene copies (ranging from 1 - 282 copies per cell), often accompanied by the formation of concatemer(s), as assessed by genomic Southern blot hybridization analysis and qPCR. Transgenic strains showed ubiquitous and continued temporal and spatial expression patterns of the transgenic GFP during most of their life cycle, from the embryonic stage to adulthood, enabling assessment of the expression pattern of the endogenous ${\beta}$-actin gene. However, a comparative evaluation of transgene copy numbers and expression levels showed that copy number-dependent expression, the stability of the ubiquitous distribution and expression efficiency per transgene copy varied among the transgenic strains. Fluorescence expression levels were positively correlated with absolute transgene copy numbers, whereas the expression efficiency per transgene copy was inversely related to the number of transgene integrant copies. Data from this study will guide the selection of potentially desirable transgenic strains with ubiquitous expression of a fluorescent transgene, not only in this marine medaka species but also in other related model fish species.