• 제목/요약/키워드: Risk-benefit method

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근거에 기반한 의약품의 유익성-위해성 평가 (Evidence-Based Benefit-Risk Assessment of Medication)

  • 이의경
    • 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.

정량적 위험성 평가에 의한 안전관리 투자의 비용-편익분석 (Cost-Benefit Analysis for Safety Management Cost using Quantitative Risk Analysis)

  • 장서일;조지훈;김태옥
    • 대한안전경영과학회지
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    • 제4권4호
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    • pp.15-26
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    • 2002
  • The quantitative evaluation method of the safety management cost was suggested to prevent a gas accident as a major industrial accident. In a gas governor station, process risk assessments such as the fault tree analysis(FTA) and the consequence analysis were performed. Based on process risk assessments, potential accident costs were estimated and the cost-benefit analysis(CBA) was performed. From the cost-benefit analysis for five classification items of safety management cost, the order of the cost/benefit ratio was estimated.

상황과 인규통계적 특성을 사전적 모형으로 연계시킨 혜택세분화 연구 -추구혜택, 지각된 위험, 상점 속성의 중요도 및 상점 선택 행동에 대한 상호작용효과를 중심으로- (Person-Situation Benefit Segments of the Female Apparel Market in Seoul by a Prior Segmentation Method Benefit Soughts of Clothing, Perceived Risk, Importanc of Store Attribute, Store-Type Choice -)

  • 홍희숙
    • 한국의류학회지
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    • 제20권6호
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    • pp.1151-1165
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    • 1996
  • The purpose of this study was to identify the pratical applicability of person-situation benefit segmentations of the female apparel market in Seoul by a prior segmentation method. The specific objectives of this study were 1) to identify the useful demographic variables for person-situation benefit segmentations of the female apparel market, 2) to assess that person- situation benefit segmentations of 1.he female apparel market are accessit)le by developing a profile of each segment based on the interactions of situation and personal characteristics on perceived risk, importance of store attributes and store-type choice, and on brand type prefered by each segment. 3) to assess the validity of person-situation benefit segmentations of the female apparel market in terms of easy accessibility. The data were collected via a questionnaire from 601 housewives of ages 20's to 50's living in Seoul, Korea. The data were analyzed by factor analysis, repeated measure two- way ANOVA and X2-test. The results of this study were as follows. First, the age-by-situation segmention basis and the education-by-situation segmention basis were useful for person-situation benefit segmentations of the female apparel market. Second, there were found three benefit segments (Youth/Fashion oriented users, Brand oriented users and Apathetic users of clothing) using age-by-situation segmention basis. Using education-by-situation segmention basis, five segments (Economic-value, Youth/Fashion, Brand/Self-expression Self-expression, and Apathetic users of clothing) were identified. And beifit segments classified by the age-by-situation segmention and education-by-situation segmention approach were accessible. Third, the pratical applicability of person-situation befeift segmentations of the female apparel market by a prior segmentation method were suggested.

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정량적 위험성 평가를 통해 제안된 도시가스 고압배관의 안전조치에 대한 비용.편익 분석 (Cost-Benefit Analysis for the Safety Measures about High Pressure Natural Gas Pipelines Proposed by Quantitative Risk Analysis)

  • 류영돈;이수경;이경식
    • 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.

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위험성평가를 이용한 노후설비에 대한 비용 편익분석 방법 (Cost-Benefit Analysis Method for Ageing Equipment of Chemical Plants Using Risk Assessment)

  • 정수민;정창모;강석민;채승빈;강승균;고재욱
    • 한국가스학회지
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    • 제24권4호
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    • pp.84-92
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    • 2020
  • 대부분의 화학공장 내 설비는 유해물질을 취급하거나, 일상적으로 접할 수 있는 온도 및 압력의 범위를 벗어난 환경에서 가동되며 이러한 응력 및 환경조건으로 인하여 노후화에 취약하다. 이러한 조건에 노출된 설비는 지속적인 손상이 누적되어 고장이 발생할 가능성이 높아짐은 물론, 정비 및 교체를 하지 않는다면 사고로 이어진다. 전세계적으로 위험성기반검사(Risk Based Inspection)라는 권고지침이 통용되고 있다. 하지만 RBI는 이미 일정시간 경과한 설비에 대해서는 한계가 존재한다. 적절한 점검을 수행하는 우리나라 울산 산업단지의 노후화 실태 조사 결과, 많은 수의 설비들이 사용기간이 20년을 경과하였다. 또한, 사고가 일어난 설비 대부분이 20년 이상 운영해 왔다. 따라서 본 연구에서는 일정 사용기간이 초과된 장치를 노후설비로 분류하는 기준을 제시하였다. 또한, 이에 대하여 정량적 위험성평가를 진행하였다. 이로 인해 도출된 해당 노후설비의 위험성을 Economic index로 표현하여 손실비용을 산정하고 Risk를 감소하기 위하여 비용편익 분석 방법을 활용한 안전투자 방법을 제안하였다. 본 연구에서 제시한 정량적 위험성 평가를 이용한 노후설비의 비용편익 분석 방법을 활용하여 노후 설비의 성능 향상 및 수명 연장, 생산 효율성 및 설비 계통 신뢰도 향상, 안전관리 비용 인식 변화, 그리고 직원의 안정감 증대, 손실비용의 감소를 기대할 수 있다.

연계된 계통간의 최적 송전 용량 산정 (Evaluation of Optimal Transfer Capability in Power System Interconnection)

  • 손현일;배인수;전동훈;김진오
    • 전기학회논문지
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    • 제59권4호
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    • pp.679-685
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    • 2010
  • As the electrical power industry is restructured, the electrical power exchange is becoming extended. One of the key information used to determine how much power can be transferred through the network is known as available transfer capability (ATC). To calculate ATC, traditional deterministic approach is based on the severest case, but the approach has the complexity of procedure. Therefore, novel approach for ATC calculation is proposed using cost-optimization method, well-being method and risk-benefit method in this paper. This paper proposes the optimal transfer capability of HVDC system between mainland and a separated island in Korea through these three methods. These methods will consider production cost, wheeling charge through HVDC system and outage cost with one depth (N-1 contingency).

가스공급기지에서 공정 위험성 평가에 의한 최적 안전관리 투자수준 결정 (Determination of Optimum Investment level for Safely Management by Process Risk Assessment at Gas Governor Station)

  • 김태옥;장서일
    • 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.

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국가단위 신규 IT인프라의 위험도 등급화 기법 개발 방향 연구 (Development Strategy on the Risk Rating Method for Nationwide Emerging IT Infrastructure)

  • 김상균
    • 산업기술연구
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    • 제30권B호
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    • pp.11-16
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    • 2010
  • To provide a development strategy on the method which assesses a potential risk of nationwide emerging IT infrastructure in planning and design phase, and to classify the assessment result into 5 levels is the goal of this research. The development strategy provided in this paper could improve a benefit-cost-ratio of investments on emerging IT infrastructure. With a premature assessment of the potential risks of a nationwide emerging IT infrastructure which needs astronomical amount of public funds, it could show a way of systematic investments on security systems and improve a benefit-cost-ratio of investments on emerging IT infrastructure. Also, this approach might improve the safety of nationwide IT infrastructure. It could identify and provide an optimized solution for the potential risks of nationwide IT infrastructure.

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Delphi기법을 통한 교통수요예측 Risk Management 적용 방안 (Application of Risk Management to Forecasting Transportation Demand by Delphi Technique)

  • 정성봉
    • 대한안전경영과학회지
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    • 제13권2호
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    • pp.267-273
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    • 2011
  • Since 'The Act on Private Investment of The Infrastructure' was established in 1994, private investment as well as government's investment in transport infrastructure has been active. However investment in transport infrastructure has more risks than others' due to uncertainty both in traffic volume and in construction cost. In the current appraisal procedure of deciding transportation infrastructure investment, instead of risk management, the sensitivity analysis considering only the changes of benefit, cost and social discount rate which are main factor affecting economic feasibility is carried out. Therefore the uncertainty of various factors affecting demand, cost and benefit are not considered in feasibility study. In this study the problems in current investment appraisal system were reviewed. Using Delphi technique the major factors which have high uncertainty in feasibility study were surveyed and then improvement plan was suggested in the respective of classic 4 step demand forecasting method. The range estimation technique was also mentioned to deal with the uncertainty of the future.

Decision-making of alternative pylon shapes of a benchmark cable-stayed bridge using seismic risk assessment

  • Akhoondzade-Noghabi, Vahid;Bargi, Khosrow
    • Earthquakes and Structures
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    • 제11권4호
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    • pp.583-607
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    • 2016
  • One of the main applications of seismic risk assessment is that an specific design could be selected for a bridge from different alternatives by considering damage losses alongside primary construction costs. Therefore, in this paper, the focus is on selecting the shape of pylon, which is a changeable component in the design of a cable-stayed bridge, as a double criterion decision-making problem. Different shapes of pylons include H, A, Y, and diamond shape, and the two criterion are construction costs and probable earthquake losses. In this research, decision-making is performed by using developed seismic risk assessment process as a powerful method. Considering the existing uncertainties in seismic risk assessment process, the combined incremental dynamic analysis (IDA) and uniform design (UD) based fragility assessment method is proposed, in which the UD method is utilized to provide the logical capacity models of the structure, and the IDA method is employed to give the probabilistic seismic demand model of structure. Using the aforementioned models and by defining damage states, the fragility curves of the bridge system are obtained for the different pylon shapes usage. Finally, by combining the fragility curves with damage losses and implementing the proposed cost-loss-benefit (CLB) method, the seismic risk assessment process is developed with financial-comparative approach. Thus, the optimal shape of the pylon can be determined using double criterion decision-making. The final results of decision-making study indicate that the optimal pylon shapes for the studied span of cable-stayed bridge are, respectively, H shape, diamond shape, Y shape, and A shape.