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.
This study proposes a multi-scale dynamic system reliability analysis of control system as a method of quantitative evaluation of its performance in probabilistic terms. In this second paper, we discuss the control effect of the viscous damper on the seismic performance of the structure-level failure. Since the failure of one structural member does not necessarily cause the collapse of the structural system, we need to consider a set of failure scenarios of the structural system and compute the sum of the failure probabilities of the failure scenarios where the statistical dependence between the failure scenarios should be taken into account. Therefore, this computation requires additional system reliability analysis. As a result, the proposed approach takes a hierarchial framework where the failure probability of a structural member is computed using a lower-scale system reliability with the union set of time-sequential member failures and their statistical dependence, and the failure probability of the structural system is again computed using a higher-scale system reliability with the member failure probabilities obtained by the lower-scale system reliability and their statistical dependence. Numerical results demonstrate that the proposed approach can provide an accurate and stable reliability assessment of the control performance of the viscous damper system on the system failure. Also, the parametric study of damper capacity on the seismic performance has been performed to demonstrate the applicability of the proposed approach through the probabilistic assessment of the seismic performance improvement of the damper system.
Purton, Leon;Kourousis, Kyriakos I.;Clothier, Reece;Massey, Kevin
International Journal of Aeronautical and Space Sciences
/
v.15
no.1
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pp.54-62
/
2014
The Air and Space Interoperability Council (ASIC) has adopted the European Defence Agency (EDA) process for inter-regulatory military airworthiness authority recognition. However, there are gaps in the application of this process to nations outside of the European Union. This paper proposes a model that can effectively map diverse technical airworthiness regulatory frameworks. This model, referred to as the Product-Behaviour-Process (PBP) Bow-Tie model, provides the systematic structure needed to represent and compare regulatory frameworks. The PBP Bow-Tie model identifies key points of difference that need to be addressed, during inter-agency recognition between the two regulatory authorities. With the intention to adopt global use of the EDA process, the proposed PBP Bow-Tie model can be used as a basis for the successful recognition of regulatory frameworks outside of the European Union. Iris plots produced from the implementation of this model are presented, and proposed as a suitable means of illustrating the outcome of an assessment, and of supporting the comparisons of results. A comparative analysis of the Australian Defence Force and New Zealand Defence Force airworthiness regulatory frameworks is used as a case study. The case study clearly illustrates the effectiveness of the model in discerning regulatory framework differences; moreover, it has offered an opportunity to explore the limitations of the Iris plot.
Recently, a number of researches acknowledge the importance of 'reflection' and 'reflective teacher education,' and they highlight the implication of 'reflection' on the teacher's profession or the teacher education. The reflective thought is interpreted as a subject that should be taught or a sort of strategy that a teacher should learn, while the aspect is excluded that reflection is the interaction between the innate knowledge and the practice. As a result, the reflective teacher education programs that increase the level of reflection are developed and practiced, and the reflection is accepted as a tool for increasing teacher professionalism. Reflective teaching is en essential and basic element for the development of teacher knowledge. In particular, such teacher knowledge might be being gradually expanded by a teacher's self-assessment on reflection on his own instruction. For this reason, this study develops an assessment framework on instruction which is comprized of teacher knowledge and instructional process. To accomplish this, in this study, teacher knowledge is considered as a whole practice knowledge combined by subject matter knowledge, understanding of learners, teaching and learning methods and assessment, and instructional environment. Also, success on instruction in mathematics class might depend on the acquisition of teacher knowledge, instructional planning, instructional execution, and furthermore reflection on instruction. Especially, this study emphasizes that 'reflection on instruction', the most important step of instruction be reflected and examined by the teacher himself.
Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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v.17
no.2
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pp.227-234
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2019
A user-friendly modeling interface is developed for a process-based total system performance assessment framework (APro) specialized for a generic geological disposal system for high-level radioactive waste. The APro modeling interface is constructed using MATLAB, and the operator splitting scheme is used to combine COMSOL for simulation of multiphysics and PHREEQC for the calculation of geochemical reactions. As APro limits the modeling domain to the generic disposal system, the degree of freedom of the model is low. In contrast, the user-friendliness of the model is improved. Thermal, hydraulic, mechanical and chemical processes considered in the disposal system are modularized, and users can select one of multiple modules: "Default process" and multi "Alternative process". APro mainly consists of an input data part and calculation execution part. The input data are prepared in a single EXCEL file with a given format, and the calculation part is coded using MATLAB. The final results of the calculation are created as an independent COMSOL file for further analysis.
Joo, Wooyeong;Ahn, SoEun;Joo, Jin Chul;Cho, Dong-Gil;Bahn, Gwon Soo;Jung, Jinho;Hyun, Kyoung Hak
Ecology and Resilient Infrastructure
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v.6
no.1
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pp.69-76
/
2019
Ecosystem services are contributing to human welfare by enabling us to maintain our survival and quality of life. A metod of quantifying ecological functions is needed. We discussed the introduction and applications of ecosystem services to applied ecological engineering. The concept and assessment system of ecosystem services were applied to the economic valuation of river, the construction of blue-green-white network in urban area, ecological restoration, and integrated water management in Korea. The conceptual framework and assessment of ecosystem services can be used to promote value of ecological protection and restoration, helping stakeholders understand the benefits of ecosystems and increasing applications of the applied ecological engineering.
Journal of the Korea Institute of Building Construction
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v.24
no.3
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pp.363-370
/
2024
The escalating frequency and intensity of natural disasters and extreme weather events due to climate change have caused increasingly severe damage to societal infrastructure and buildings. Government agencies and private companies are actively working to evaluate these damages, but existing technologies and methodologies often fall short of meeting the practical demands for accurate assessment and prediction. This study proposes a novel approach to assess building damage resulting from natural disasters, focusing on typhoons-one of the most devastating natural hazards experienced in the country. The methodology leverages deep learning algorithms to evaluate typhoon-related damage, providing a comprehensive framework for assessment. The framework and outcomes of this research can provide foundational data for the evaluation of natural disaster-induced damage over the entire life cycle of buildings and can be applied in various other industries and research areas for assessing risk of damage.
Journal of the Korean Society for Marine Environment & Energy
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v.12
no.4
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pp.307-319
/
2009
Carbon dioxide capture and storage (CCS) technology has been regarded as one of the most possible and practical option to reduce the emission of carbon dioxide ($CO_2$) and consequently to mitigate the climate change. Korean government also have started a 10-year R&D project on $CO_2$ storage in sea-bed geological structure including gas field and deep saline aquifer since 2005. Various relevant researches are carried out to cover the initial survey of suitable geological structure storage site, monitoring of the stored $CO_2$ behavior, basic design of $CO_2$ transport and storage process and the risk assessment and management related to $CO_2$ leakage from engineered and geological processes. Leakage of $CO_2$ to the marine environment can change the chemistry of seawater including the pH and carbonate composition and also influence adversely on the diverse living organisms in ecosystems. Recently, IMO (International Maritime Organization) have developed the risk assessment and management framework for the $CO_2$ sequestration in sub-seabed geological structures (CS-SSGS) and considered the sequestration as a waste management option to mitigate greenhouse gas emissions. This framework for CS-SSGS aims to provide generic guidance to the Contracting Parties to the London Convention and Protocol, in order to characterize the risks to the marine environment from CS-SSGS on a site-specific basis and also to collect the necessary information to develop a management strategy to address uncertainties and any residual risks. The environmental risk assessment (ERA) plan for $CO_2$ storage work should include site selection and characterization, exposure assessment with probable leak scenario, risk assessment from direct and in-direct impact to the living organisms and risk management strategy. Domestic trial of the $CO_2$ capture and sequestration in to the marine geologic formation also should be accomplished through risk management with specified ERA approaches based on the IMO framework. The risk assessment procedure for $CO_2$ marine storage should contain the following components; 1) prediction of leakage probabilities with the reliable leakage scenarios from both engineered and geological part, 2) understanding on physio-chemical fate of $CO_2$ in marine environment especially for the candidate sites, 3) exposure assessment methods for various receptors in marine environments, 4) database production on the toxic effect of $CO_2$ to the ecologically and economically important species, and finally 5) development of surveillance procedures on the environmental changes with adequate monitoring techniques.
Journal of the Korean Society of Environmental Restoration Technology
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v.27
no.2
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pp.17-28
/
2024
In order to achieve the management goals (30by30) mandated by the Kunming-Montreal Global Biodiversity Framework, this study established the site-level assessment criteria for OECMs, tailored to domestic circumstances using the Delphi analysis. Subsequently, a site-level assessment was conducted on the National Gariwangsan Natural Recreation Forest. As a result of the study, the initial step involved presenting criteria for the site-level assessment of OECMs, with 'consent for the assessment and recognition of OECM by competent and management authority' proposed as a prerequisite. Subsequently, seven evaluation criteria were established, including 'other than a legally protected area', 'spatially separated area with defined boundaries', 'effective in-situ conservation of biodiversity', 'sustainable management based on the competent and management authority', 'long-term sustainability of conservation outcomes', and 'provision of ecosystem services'. The results of applying site-level assessment criteria to the National Gariwangsan Natural Recreation Forest indicate that six criteria were met, while one criterion (sustainable management based on the competent and management authority) requires further improvement. Specifically, the key competent and management authorities for the National Gariwangsan Natural Recreation Forest are the Korea Forest Service and the National Natural Recreation Forest Management Office, with competent and management organizations established. However, the management focus is primarily on providing forest recreation services centered on users and facilities, making it difficult to confirm the long-term biodiversity conservation plans and implementation by the competent and management authorities. Therefore, it is deemed necessary to improve the long-term biodiversity conservation plans and implementation for the recognition of the National Gariwangsan Natural Recreation Forest as an OECM.
Kim, Seung Won;Choi, Sangjun;Phee, Young Gyu;Kim, Kab Bae
Journal of Korean Society of Occupational and Environmental Hygiene
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v.25
no.4
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pp.482-492
/
2015
Objectives: Exposure Assessment for workplace hazards where the exposure level is below occupational exposure limits(OELs) has been performed without considering either the degrees of risk or exposure levels and has failed to lead to intervention in many cases. The objective of this study was to suggest and test an application framework for risk assessment methodology under the current exposure assessment system in Korea. Materials: First, we investigated the exposure assessment systems in Korea and other countries. To adopt some risk assessment techniques, we also analyzed risk assessment systems and compared them to exposure assessment systems. A few suggestions were made. We held a public hearing during an industrial hygiene conference and took surveys using a questionnaire. Results: The first suggestion was to implement the risk assessment and exposure assessment through a "one-stop" system. In that case, one expected question would be who has been doing the jobs so far. In most cases, industrial hygiene consulting services or laboratories have been performing exposure assessment for business owners. Business owners are required to perform risk assessment. As two different groups of people will be required to implement two things in a one-stop system, they need to share information. As an information vehicle to share information, commonly filed survey checklists were suggested. The second suggestion was to categorize exposure level into four groups instead of the current binary divisions based on OELs. In the risk assessment system, exposure level is divided into four groups utilizing the cut-points of 10%, 50%, and 100% of OELs. The same schema can be adopted in the exposure assessment system and different levels of requirements can be assigned for each group. The third suggestion was regarding the regulation system. To provide the suggestions some thrust toward being implemented in the field, changes should be made in the legal system. Two different types of new exposure assessment result reporting forms were suggested. Some investigations such as an ergonomic survey are officially accepted as risk assessment under the current legal system. A few items were suggested to be included in the exposure assessment result reporting to be accepted as risk assessment. A pilot study in two small factories was performed and pointed out the strengths and weakness of our suggestions. Conclusions: Discussions and studies on the improvement of the exposure assessment system have been held for decades and no tangible changes have yet been made. We hope this result can help realize healthy lives for workers in Korea.
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