• 보건의료기술평가
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• 제1권1호
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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.

• 한국잡초학회지
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• 제13권4호
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• pp.195-202
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• 1993

The benefits of pesticides in improving the food quantity and quality requirements for an increasing world population are significant, and they can be described in agronomic, economic and social terms. The risks are assessed from the hazards which are likely to occur in practice ; the hazards are defined by the toxicity of the pesticide to non-target organisms at various exposure levels. There are ways of reducing the risks (mainly by reducing exposure in practice) and improving the benefits of pesticides ; these are known as risk management and benefit management respectively. The overall risk-benefit assessment is facilitated if each component can be expressed in financial terms, but it must be made nationally or locally on a sound technical basis against the prevailing agronomic, socio-economic and political circumstances. Paraquat is used to illustrate the risk-benefit assessment process in general terms, and the conclusion is that the benefits greatly outweigh the risks. It is important to keep the risks of pesticides in perspective with those associated with other naturally occurring chemicals in our diet and with other everyday aspects of life. In an overall context, the pesticide risk is small.

• 한국산업보건학회지
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• 제16권4호
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• pp.413-427
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• 2006

It is necessary to study and develop guidelines for providing comfort and health indoor air quality for office workers since air-tight envelope system of current office building may cause poor indoor air quality. The purpose of this study is to propose guideline for volatile organic compounds in office base on the field study, human health risk assessment and cost-benefit analysis. The field study was conducted to survey the concentrations of volatile organic compounds in indoor air of 69 offices from June to September, 2005 in Seoul and Gyeonggi-do. The rate of excess to guideline of volatile organic compounds in indoor air of new apartment on the Ministry of Environment in Korea(MOE) was surveyed 37.6% for benzene, 6.8% for toluene, and 1.5% for ethylbenzene. As the result of human health risk assessment, mean cancer risk did not exceed 10-6 which is guideline of US.EPA. Also, total hazard index did not exceed 1 which is guideline of US.EPA. Through the cost-benefit analysis of angle on the social-economics to verify the necessary to establish the standards of volatile organic compounds for improvement and development of indoor air quality in office, the present value of benefit was higher than the present value of cost. With the above considerations in mind, it is suggested that the field study for indoor air quality in offices should be expanded and human health risk assessment and cost-benefit analysis be performed th offer scientific data for decision-making of policy for improvement and management of indoor air quality in office.

• Computational Structural Engineering : An International Journal
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• 제2권1호
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• pp.19-23
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• 2002

A reliability-based cost-benefit model for the risk management of oil platforms in the formulation of optimal decisions based on life-cycle consideration is proposed. The model is based on structural risk assessments and the integration of social issues and economics into the management decision process. Structural risks result from the platform's exposure to the random environmental loading associated with the offshore site where it is located. Several alternative designs of a typical platform are proposed and assessed from the cost-effectiveness viewpoint. This assessment is performed through the generation of cost/benefit relationships that are used, later on, to select the optimal design.

• Environmental Analysis Health and Toxicology
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• 제20권2호
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• pp.97-108
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• 2005

This study is to estimate differences, relationships and related factors of environmental risk perception and perceived benefit among residents and workers. A self-administered questionnaire survey using a structured instrument was carried out to residents and workers in industrial area during April, 2002. Total number of participants were 657 including 329 residents and 328 workers. Participants assessed environmental risk perception, self- assessed knowledge, trust in authorities and perceived benefit associated with 10 products manufactured in industrial area. There were difference in environmental risk perception, knowledge and trust in authorities and perceived benefit among residents and workers. Especially, trust in authorities and perceived benefit were statistically significant difference among residents and workers. Inverse relationships between environmental risk perception and perceived benefit have been observed for different products. In other words, the greater the perceived benefit, the lower the perceived risk, and vice versa. Factors mostly associated with participant's characteristics of environmental risk perception were age. marriage status (workers), education level (workers). There was statistically significant difference. Perceived benefit was statistically significant difference with sex, marriage status, residence duration, education level (workers). Related factors of environmental risk perception among residents and workers were age, trust in authorities. And factors affecting the perceived benefit were sex, age, education level (workers), and trust in authorities (workers). According to the results, people having high trust in the authorities perceived less risks than people having low in the authorities. To improve the communication of risk information, further study focus on assessment of experts, government and stakeholder in industrial area. Methodologies of this study can be used as the basis for investigating the structure of public perception of environmental products risks and benefit, designing a public information and risk communication program, and developing policy actions to improve acceptance.

• 한국항해항만학회지
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• 제35권1호
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• pp.23-30
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• 2011

본 논문은, 국적일반화물선 공식안전성평가(Formal Safety Assessment, 이하 FSA) 연구의 1, 2 단계에 해당하는 위험요소 식별(Hazard identification) 및 식별된 사고 시나리오에 대한 위험도 분석(Risk analysis) 결과를 소개한 "국적일반화물선 초기안전성평가 연구(1)"에 이어 FSA 연구의 3, 4 그리고 5단계를 수행한 내용으로, 국적일반화물선의 운용 중 발생 가능한 위험을 저감할 수 있는 위험도제어방안들(Risk Control Options)을 식별하는 단계(Step 3)와 식별된 위험도제어방안들 중 전문가 의견수렴을 통하여 선별된 위험도제어방안들을 대상으로 한 비용-효과 평가 단계(Step 4: Cost-Benefit Assessment) 그리고 비용-효과 평가의 결과를 정리하여 국적일반화물선의 안전성 제고를 위한 구체적인 방안을 제안하는 단계(Step 5: Recommendation for Decision Making)의 결과를 소개하였다.

• 한국가스학회지
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• 제13권3호
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• pp.22-27
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• 2009

이 논문은 한국가스안전공사가 도시가스 고압배관에 대한 안전성평가를 실시하고 안전관리 조치를 권고하는 경우 그 안전관리조치가 합리적으로 실행가능한 것인지를 판단하기 위한 비용.편익분석 방법으로 PF(Proportion Factor)를 사용할 것을 제시하였다. 또한, 설치 예정인 도시가스 고압배관에 대하여 정량적 위험성평가를 실시하고, 평가결과에 따라 개선 권고한 안전조치에 대하여 VPF와 PF를 이용한 비용 편익분석을 실시하여 제시한 위험감소조치가 합리적으로 실행가능한 것임을 확인할 수 있었다. 본 논문에서 제시한 비용 편익분석방법은 국내에서 안전성평가를 실시하고 위험감소조치를 제시하는 경우 그 조치가 합리적으로 실행 가능한 것인지를 입증하는데 유용하게 활용될 수 있을 것으로 판단된다.

• 한국산업보건학회지
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• 제25권2호
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• pp.134-145
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• 2015

Objectives: An objective of this study was to perform a risk assessment and social cost-benefit analysis for revising permissible exposure limits for seven substances: Nickel(Insoluble inorganic compounds), benzene, carbon disulfide, formaldehyde, cadmium(as compounds), trichloroethylene, touluene-2,4-diisocyanate. Materials and Methods: The research methods were divided into risk and hazard assessment and cost-benefit analysis. The risk and hazard assessment for the seven substances consists of four steps: An overview of GHS MSDS(1st), review of document of ACGIH's TLVs (2nd), comparison between international occupational exposure limits and domestic permissible exposure limits(3rd), and analysis of excess workplace and excess rate for occupational exposure limits based on previous work environment measurement data(4th). Total cost was estimated using cost of local exhaust ventilation, number of excess workplace and penalties for exceeding a permissible exposure limit. On the other hand, total benefit was calculated using the reduction rate of occupational disease, number of workplaces treating each substance and industrial accident compensation. Finally, the net benefit was calculated by subtracting total cost from total benefit. Results: All the substances investigated in this study were classified by CMR(Carcinogens, Mutagens or Reproductive toxicants) and their international occupational exposure limits were stricter than the domestic permissible exposure limits. As a result of excess rate analysis, trichloroethylene was the highest at 11%, whereas nickel was the lowest at 0.5%. The excess rates of all substances except for trichloroethylene were observed at less than 10%. Among the seven substances, the total cost was highest for trichloroethylene and lowest for carbon disulfide. The benefits for the seven substances were higher than costs estimated based on strengthening current permissible exposure limits. Thus, revising the permissible exposure limits of the seven substances was determined to be acceptable from a social perspective. Conclusions: The final revised permissible exposure limits suggested for the seven substances are as follows: $0.2mg/m^3$ for nickel, 0.5 ppm(TWA) and 2.5 ppm(STEL) for benzene, 1 ppm(TWA) for carbon disulfide, $0.01mg/m^3$(TWA) for cadmium, 10 ppm(TWA) and 25 ppm(STEL) for trichloroethylene, 0.3 ppm(TWA) for formaldehyde, and 0.005 ppm(TWA) and 0.02 ppm(STEL) for toluene diisocynate(isomers).

• Journal of Ship and Ocean Technology
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• 제4권4호
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• pp.19-33
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• 2000

For the prevention of marine accidents based on human factor, the risk assessment analysis procedure is proposed which consists of (1) the structural analysis of marine accident, (2) the estimation of incidence probability based on the Fault Tree analysis, (3) the prediction of ef-fectiveness to reduced the accident risk by suitable countermeasures in the specified functional system, and (4) the risk assessment by means of minimizing of the total cost expectation and the background risk. As a practical example, the risk assessment analysis for preventing is investigated using the proposed method.

• 한국가스학회지
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• 제7권3호
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• pp.1-6
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• 2003

본 연구에서는 가스공급기지를 대상으로 공정 위험성 평가에 의해 최적 안전관리 투자수준을 결정하는 방법을 제시하였다. 이를 위해 가스공급기지에서 공정 위험성 평가(HAZOP, FTA, CA)를 실시하여, 안전관리비에 대한 잠재재해손실비와 편익을 산출하였다. 그 결과, 비선형 회귀분석법에 의하여 투자비와 편익의 경향을 알 수 있었으며, 안전관리 투자비와 잠재재해손실비를 비교$\cdot$분석하여 적정 안전관리 투자수준을 결정할 수 있었다.