• Title/Summary/Keyword: System Safety Assessment

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Application of Molecular Diagnostics Technology in the Development of a Companion Diagnostics for Malignant Solid Tumors (악성 고형암의 항암제 동반진단 기술에서 분자진단기술의 적용)

  • Kim, Jin-Hee
    • The Journal of the Korea Contents Association
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    • v.19 no.3
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    • pp.365-374
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    • 2019
  • Unlike benign tumors, malignant tumors are capable of metastasis, easy to relapse, poor survival, and low quality of life. In Korea, here is a tendency to treat the tumors collectively according to the General Principles of Cancer Chemotherapy(GPCC) of the Health Insurance Review & Assessment Service (HIRA). But recently, companion diagnostics(CDx) is recommended rather than unilateral medication because biomarker-based molecular diagnostics is possible to predict the drug response of patients before drug treatment. Not only domestic but also overseas Food and Drug Administratio (FDA) recommends the development of the CDx system at the stage of drug development to ensure the responsiveness and safety of medicines. In this study, I focused on the necessity of CDx development direction as well as CDx development status through literature review. Furthermore I also discussed CDx types according to the molecular diagnostic technology such as immunohistochemistry (IHC), polymerase chain reaction (PCR), in situ hybridization (ISH), and next-generation sequencing (NGS) not only in the approved CDx but also in the developing one by US FDA. And I suggested the technology issue of CDx development process such as a selection of molecular diagnostics at the time of release, a clear understanding of the CDx mechanism, and a convergence of drug with CDx development. The necessity of social insurance system also was proposed for CDx development.

A Biomechanics-Based Ergonomic Analysis for Footware Development (풋웨어 개발을 위한 생체역학 기반 인간공학적 분석 : B-boy 신발 개발을 중심으로)

  • Hah, Chong-Ku;Jang, Young-Kwan;Kim, Jin-Hyun
    • Journal of Convergence for Information Technology
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    • v.9 no.8
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    • pp.140-147
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    • 2019
  • The purpose of this study is to find biomechanical parameters for optimal shoes production through an ergonomic usability assessment of five existing types of shoes preferred by B-BOY. Ten experts and ten non-experts participated in the experiment, and 12 infrared cameras (Qualis, Oqus), force plate (Kistler, 9286AA) and foot pressure plate (Zebris Gmbh, Zebris PDM-System) were used to obtain the data. The results of the study are as follows. First, P shoes with a friction coefficient of 0.38 and a free moment of 0.32 N/m/kg are desirable in terms of traction capability and safety. Second, on the cushion, it was found that the N shoes 2.51 N, sec/kg and non-expert, and 2.86 N and sec/kg were suitable. Third, it is deemed appropriate for C shoes with a forefoot average pressure of 10.11 KPa (right), 10.05 KPa (left), and V shoes with a rearfoot average pressure of 8.4 KPa (right) and 8.36 KPa (left). In conclusion, the combination of the structure and material of V shoes should be developed for traction and stability, N shoes for cushion, and walking balance for C and V shoes.

Analysis of Photovoltaic Potential of Unused Space to Utilize Abandoned Stone Quarry (폐채석장 부지 활용을 위한 유휴 공간의 태양광 발전 잠재량 분석)

  • Kim, Hanjin;Ku, Jiyoon;Park, Hyeong-Dong
    • Tunnel and Underground Space
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    • v.31 no.6
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    • pp.534-548
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    • 2021
  • In this paper, the feasibility of generating solar power near an abandoned quarry is examined with the objectives of resolving the essential problems that quarries encounter, such as rockfalls and space usage issues. On an abandoned quarry site in Sadang, Seoul, Republic of Korea, two different PV installation methods were analyzed. The first is attaching PV directly on the quarry slope. Since there are no corresponding safety standards and precedents for installing solar panels directly on slopes, the power generation potential was calculated by using topographic data and reasonable assumptions. The surface area of cut slope section was extracted from the Digital Elevation Model(DEM) via ArcGIS and Python programming to calculate the tilt and power capacity of installable panels. The other approach is installing PV as a rockfall barrier, and the power generation potential was analyzed with the assumption that the panel is installed in the direction of facing solar irradiation. For the derivation of power generation, the renewable energy generation analysis program SAM(System Advisor Model) was used for both methods. According to the result, quarries that have terminated resource extraction and remain devastated have the potential to be transformed into renewable energy generation sites.

Feedback Analysis Technique for Tunnel Safety by Using Displacements Measured during the Tunnel Excavation (터널굴착변위를 활용한 시공중 피드백 해석기법 연구)

  • Park, Si-Hyun;Shin, Young-Suk
    • Journal of the Korean Geotechnical Society
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    • v.24 no.1
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    • pp.81-89
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    • 2008
  • The purpose of this study is to develop a new technique to quickly assess the quantitative stability of a tunnel by using measured displacement at the tunnel construction site. To achieve this purpose, in this study, a critical strain concept was introduced for the first time and applied to an assessment of a tunnel under construction. The new technique calculates numerically the strains of the surrounding ground by using displacements measured during tunnel excavation. The techniques considering the relative displacement, shotcrete, and anisotropic characteristics of ground were newly introduced after reinvestigating the existing analysis technique. In addition, an analysis module was developed based on the proposed analysis technique in this study, and the applicability of the developed module was verified. To verify the module, first of all, the calculated excavation displacements of a cylindrical tunnel by analytic method and commercial programs (Pentagon-3D, Flac-2D) were compared for the confirmation of applicability of commercial programs. Then, the calculated excavation displacements under the same initial condition, both with and without a shotcrete lining, by two commercial programs were compared. finally, we assess the load condition and material properties of in-situ ground by inputting tunnel excavation displacement, which was calculated by a commercial program, into the developed analysis module (FAST-Ver. 1.2, feedback Analysis System for Tunneling), and checked whether the assessed results conform to the originally assumed values.

Quantitative Deterioration and Maintenance Profiles of Typical Steel Bridges based on Response Surface Method (응답면 기법을 이용한 강교의 열화 및 보수보강 정량화 이력 모델)

  • Park, Seung-Hyun;Park, Kyung Hoon;Kim, Hee Joong;Kong, Jung-Sik
    • KSCE Journal of Civil and Environmental Engineering Research
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    • v.28 no.6A
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    • pp.765-778
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    • 2008
  • Performance Profiles are essential to predict the performance variation over time for the bridge management system (BMS) based on risk management. In general, condition profiles based on experts opinion and/or visual inspection records have been used widely because obtaining profiles based on real performance is not easy. However, those condition profiles usually don't give a good consistency to the safety of bridges, causing practical problems for the effective bridge management. The accuracy of performance evaluation is directly related to the accuracy of BMS. The reliability of the evaluation is important to produce the optimal solution for distributing maintenance budget reasonably. However, conventional methods of bridge assessment are not suitable for a more sophisticated decision making procedure. In this study, a method to compute quantitative performance profiles has been proposed to overcome the limitations of those conventional models. In Bridge Management Systems, the main role of performance profiles is to compute and predict the performance of bridges subject to lifetime activities with uncertainty. Therefore, the computation time for obtaining an optimal maintenance scenario is closely related to the efficiency of the performance profile. In this study, the Response Surface Method (RSM) based on independent and important design variables is developed for the rapid computation. Steel box bridges have been investigated because the number of independent design variables can be reduced significantly due to the high dependency between design variables.

Clinical assessment of whitening efficacy and safety of in-office tooth whitening system containing 15% hydrogen peroxide with or without light activation (15% 과산화수소 함유 전문가용 치아 미백제의 광활성화 여부에 따른 미백효과 및 안전성에 관한 임상평가)

  • Noh, Young-Suk;Rho, Young-Jee;Yoo, Yeon-Jee;Lee, Hyang-Ok;Lim, Sang-Min;Kweon, Hyun-Jeong;Kim, Ye-Un;Park, Seong-Yeon;Yoon, Hee-Young;Lee, Jung-Hyun;Lee, Chan-Hee;Oh, So-Ram;Kum, Kee-Yeon
    • Restorative Dentistry and Endodontics
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    • v.36 no.4
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    • pp.306-312
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    • 2011
  • Objectives: This clinical study evaluated the effect of light activation on the whitening efficacy and safety of in-office bleaching system containing 15% hydrogen peroxide gel. Materials and Methods: Thirty-three volunteers were randomly treated with (n = 17, experimental group) or without light activation (n = 16, control group), using Zoom2 white gel (15% $H_2O_2$, Discus Dental) for a total treatment time of 45 min. Visual and instrumental color measurements were obtained using Vitapan Classical shade guide and Shadepilot (DeguDent) at screening test, after bleaching, and 1 month and 3 month after bleaching. Data were analyzed using t-test, repeated measure ANOVA, and chi-squared test. Results: Zoom2 white gel produced significant shade changes in both experimental and control group when pre-treatment shade was compared with that after bleaching. However, shade difference between two groups was not statistically significant (p > 0.05). Tooth shade relapse was not detected at 3 months after bleaching. The incidence of transient tooth sensitivity was 39.4%, with being no differences between two groups. Conclusions: The application of light activation with Zoom2 white gel system neither achieved additional whitening effects nor showed more detrimental influences.

Assessment on HACCP Recognition & Sanitary Management of the Industry Foodservice Manager in Seoul (식품 위해 요소 중점 관리 기준에 대한 서울 지역 사업체 급식 관리자의 위생관리평가)

  • 이헌옥;심재영;김영경;조민호;최호순;엄애선
    • Korean journal of food and cookery science
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    • v.17 no.6
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    • pp.542-548
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    • 2001
  • Hazard Analysis Critical Control Point(HACCP) is becoming an important component of food safety worldwide. The aim of this study was to investigate comprehensively the education and knowledge level of food service managers on HACCP as well as applying HACCP system to industrial foodservice. Total 247 foodservice managers participated in the survey and 159 responses were used for analysis. The results were as follows: 1) 89% of foodservice managers were educated about HACCP, and 40.9% felt they did fully understand HACCP and 47.8% did half. 2) The score for the implementation of HACCP was in the order of apparatus and facility sanitation, personal sanitation, and time-temperature/etc. sanitation. 3) Foodservice managers who were taught HACCP kept a deep attention to food and personal sanitation, compared with those without education(p<0.05). However, the education time on HACCP affected conducting safety management. The results suggest that education and understanding of HACCP are positively related, and understanding of HACCP has a positive influence on conducting safety management.

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An Assessment on the Urban Riverfront in Shincheon, Daegu - Focused on a Universal Design Concept - (대구광역시 신천의 친수공간 평가 연구 - 유니버설디자인 개념을 중심으로 -)

  • Choi, Dong-Sik;Moon, Ji-Won;Kim, Shang-Hee
    • Journal of the Korean Institute of Landscape Architecture
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    • v.40 no.2
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    • pp.1-14
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    • 2012
  • The purpose of this study is to derive a desirable riverfront construction plan to me for the activities of citizens through the evaluation and analysis of the urban riverfront space from the perspective of universal design. Therefore, previous studies were examined in order to induce evaluation tools that bhve been grafted from the universal design concept; in addition, a field survey was conducted in Shincheon, Daegu, which was selected as the study target, in order to induce problems and improvement directions from the perspective of universal design. The major results can be summarized as follows. (1) In the 'fairness' aspect, all the items such as installation of integrated functional signage, showing pictures, symbols, foreign language signs, and restroom entrances signage were determined to be 'All Unsuitable' for all sections; and therefore, it is necessary to improve the fairness of usage for everybody. (2) In the 'Functionality(Usability)' aspect, all items such as installation of bicycle paths beside access roads, installation of integrated functional signs, and night light signs were determined to be 'All Unsuitable' for all sections; therefore, it is necessary to improve the functionalities of these facilities. (3) In the 'Convenience' aspect, all items such as the installation of bicycle parking areas, continuous rest facilities, and back and ann support(handles) at resting facilities were determined to be 'All Unsuitable' for many sections; therefore, it is necessary to improve these facilities for the convenience of usage. (4) In the 'Information(Recognizability)' aspect, all items such as showing pictures, symbols, foreign languages and installation of night light signs, and restroom entrances signage were determined to be 'All Unsuitable' for all sections; therefore, it is necessary to improve the recognizability to minimize misunderstandings and confusion. (5) In the 'Safety' aspect, all items such as the installation of safe pedestrian paths in parking areas, using anti-slip and shock absorption materials on restroom floors, and the continuous installation of pedestrian paths that are separate from bicycle paths were determined to be 'All Unsuitable' for all sections; therefore, it is necessary to improve the safety to prevent accidents. (6) In the 'Amenity' aspect, access roads, parking areas, hygiene facilities, convenience facilities, and waterside facilities for many sections were determined to be 'All Unsuitable'; therefore, it is necessary to conduct more concentrated hygiene management. (7) In the 'Accessibility(Mobility)' aspect, all items such as the installation of safe pedestrian paths in parking areas, and continuous pedestrian paths that are separate from bicycle paths were determined to be 'All Unsuitable' for all sections; therefore, it is necessary to improve the accessibility to provide safety and convenience. (8) In the 'Durability' aspect, access roads, parking areas, rest facilities, convenience facilities, fitness facilities, and waterside facilities were determined to be 'All Unsuitable' for many sections, therefore, it is necessary to improve sunken or damaged areas by inspecting facilities by section.

The Content and Risk Assessment of Heavy Metals in Herbal Pills (유통 환제의 유해 중금속 함량 및 위해도 평가)

  • Lee, Sung-Deuk;Lee, Young-Ki;Kim, Moo-Sang;Park, Seok-Ki;Kim, Yeon-Sun;Chae, Young-Zoo
    • Journal of Food Hygiene and Safety
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    • v.27 no.4
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    • pp.375-387
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    • 2012
  • The objective of this study is investigation of contamination levels and assessment of health risk effects of heavy metals in herbal pills. 31 Items and 93 samples were obtained for this investigation from major herbal medicine producing areas, herbal markets and on-line supermarkets from Jan to Jun in 2010. Inductively coupled plasma mass spectrometer method was conducted for the quantitative analysis of Pb, Cd and As. In addition, the mercury analyzer system was conducted for that of Hg without sample digestion. The average contents of heavy metals in samples were as follows : 0.87 mg/kg for Pb, 0.08 mg/kg for Cd, 2.87 mg/kg for As and 0.16 mg/kg for Hg, respectively. In addition, the average contents of heavy metals in different parts of plants, including cortex, fructus, herba, radix, seed, algae and others were 0.63 mg/kg, 3.94 mg/kg, 1.42 mg/kg, 1.05 mg/kg, 0.16 mg/kg, 22.31 mg/kg and 10.17 mg/kg, respectively. After the estimations of dietary exposure, the acceptable daily intake (ADI), the average daily dose (ADD), the provisional tolerable weekly intake (PTWI) and the relative hazard of heavy metals were evaluated. As the results, the relative hazards compared to PTWI in samples were below the recommended standard of JECFA as Pb 3.1%, Cd 0.9%, Hg 0.5%. Cancer risks through slope factor (SF) by Ministry of Environment Republic Korea and Environmental Protection Agency was $4.24{\times}10^{-7}$ for Pb and $3.38{\times}10^{-4}$ for As (assuming that the total arsenic content was equal to the inorganic arsenic). Based on our results, possible Pb-induced cancer risks in herbal pills according to parts used including cortex, fructus, herba, radix, seed, algae and others were $1.95{\times}10^{-7}$, $1.45{\times}10^{-6}$, $2.14{\times}10^{-7}$, $6.27{\times}10^{-7}$, $1.99{\times}10^{-8}$, $3.61{\times}10^{-7}$ and $9.64{\times}10^{-8}$, respectively. Possible As-induced cancer risks in herbal pills by parts used including cortex, fructus, herba, radix, seed, algae and others were $1.54{\times}10^{-5}$, $7.24{\times}10^{-5}$, $1.23{\times}10^{-4}$, $2.02{\times}10^{-5}$, $3.25{\times}10^{-6}$, $2.18{\times}10^{-3}$ and $5.67{\times}10^{-6}$ respectively. Taken together, these results indicate that the majority of samples except for some samples with relative high contents of heavy metals were safe.

Study on Basic Requirements of Geoscientific Area for the Deep Geological Repository of Spent Nuclear Fuel in Korea (사용후핵연료 심지층처분장부지 지질환경 기본요건 검토)

  • Bae, Dae-Seok;Koh, Yong-Kwon;Park, Ju-Wan;Park, Jin-Baek;Song, Jong-Soon
    • Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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    • v.10 no.1
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    • pp.63-75
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    • 2012
  • This paper gives some basic requirements and preferences of various geological environmental conditions for the final deep geological repository of spent nuclear fuel (SNF). This study also indicates how the requirements and preferences are to be considered prior to the selection of sites for a site investigation as well as the final disposal in Korea. The results of the study are based on the knowledge and experience from the IAEA and NEA/OECD as well as the advanced countries in SNF disposal project. This study discusses and suggests preliminary guideline of the disposal requirements including geological, mechanical, thermal, hydrogeological, chemical and transport properties of host rock with long term geological stabilities which influence the functions of a multi-barrier disposal system. To apply and determine whether requirements and preferences for a given parameter are satisfied at different stages during a site selection and suitability assessment of a final disposal site, the quantitative criteria in each area should be formulated with credibility through relevant research and development efforts for the deep geological environment during the site screening and selection processes as well as specific studies such as productions of safety cases and validation studies using a generic underground research laboratory (URL) in Korea.