• Title/Summary/Keyword: assessment of safety

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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 Planning Framework of BIM-based Work-Type Packaging for Educational Facility Maintenance (교육시설 유지관리 BIM 기반 공종 패키지 플래닝 프레임워크)

  • Bae, Chang-Joon;Park, Sang-Hun;Yoon, Sun-Jae;Lee, Mi-Young;Koo, Kyo-jin
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.12
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    • pp.200-210
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    • 2020
  • The maintenance of educational facilities was assembled in 12 project classifications of the Educational Improvement Program. The priorities were decided by the evaluation scores derived from the condition investigation, and maintenance works were budgeted in the order of priorities. These priorities were a schedule for conducting maintenance and an important criterion for obtaining a construction order. Several restrictions in the condition investigation exist, which derives budgets and conducts maintenance separately based on the priorities. An educational facility manager has a restriction in quantity take-off, which results in an incorrect budget. Discomfort would occur in an educational environment, and a period of infringing safety would increase. This study proposes applying a BIM in the condition investigation and the planning framework for work-type packaging. A BIM supports a budget calculation and derives evaluation scores by linking a repair and an inspection result. The work-type packaging algorithm divides a budget allocation range and derives the result of a grouped work-types applied in an equivalent space and element. As a result of applying cases, it could shorten the duration by approximately 37.4%. Its usability in selecting a grouped work-type was evaluated through an assessment with workers.

Groundwater control measures for deep urban tunnels (도심지 대심도 터널의 지하수 변동 영향 제어 방안)

  • Jeong, Jae-Ho;Kim, Kang-Hyun;Song, Myung-Kyu;Shin, Jong-Ho
    • Journal of Korean Tunnelling and Underground Space Association
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    • v.23 no.6
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    • pp.403-421
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    • 2021
  • Most of the urban tunnels in Korea, which are represented by the 1st to 3rd subways, use the drainage tunnel by NATM. Recently, when a construction project that actively utilizes large-scale urban space is promoted, negative effects that do not conform to the existing empirical rules of urban tunnels may occur. In particular, there is a high possibility that groundwater fluctuations and hydrodynamic behavior will occur owing to the practice of tunnel technology in Korea, which has mainly applied the drainage tunnel. In order to solve the problem of the drainage tunnel, attempts are being made to control groundwater fluctuations. For this, the establishment of tunnel groundwater management standard concept and the analysis of the tunnel hydraulic behavior were performed. To prevent the problem of groundwater fluctuations caused by the construction of large-scale tunnels in urban areas, it was suggested that the conceptual transformation of the empirical technical practice, which is applied only in the underground safety impact assessment stage, to the direction of controlling the inflow in the tunnel, is required. And the relationship between the groundwater level and the inflow of the tunnel required for setting the allowable inflow when planning the tunnel was derived. The introduction of a tunnel groundwater management concept is expected to help solve problems such as groundwater fluctuations, ground settlement, depletion of groundwater resources, and decline of maintenance performance in various urban deep tunnel construction projects to be promoted in the future.

The Preliminary Operator Risk Assessment of High Toxicological Pesticides in Korea (고독성 농약의 국내 농작업자 위해성 평가)

  • Hong, Soon-Sung;Jeong, Mi-Hye;Park, Kyung-Hun;You, Are-Sun;Park, Yeon-Ki;Lee, Je-Bong;Kim, Chan-Sub;Shin, Jin-Sup;Park, Jae-Eup
    • The Korean Journal of Pesticide Science
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    • v.14 no.2
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    • pp.116-122
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    • 2010
  • This study was carried out to estimate the risk of pesticide operators who use high toxicological pesticides. The class II (highly hazardous) pesticides registered in korea were 15 products, and 11 products were spray type pesticides at orchard file in 2009. The using information based on the pesticide label and the data searched through survey of actual condition on pesticides were used for calculate the pesticide operator exposure dose. The risk quotients of these pesticides against the pesticides operator were calculated as devide pesticide exposure dose by reference dose which were presented by EFSA (European Food Safety Authority), JMPR (Joint FAO Meeting on Pesticide Residues), and US/EPA (United States Environmental Protection Agency). Omethoate showed the highest risk quotient and the values were 338 and 75 when the operator spray using speed sprayer and motor sprayer respectively. Risk quotients of all class II pesticide were above 1. This result means that the risk potential of these pesticides are very high.

Assessment of Influenza Vaccine Immunogenicity in Immunocompromized Host During 2009 Influenza Season: A Single Institution Experience (면역저하환자에서 인플루엔자백신의 면역원성 평가)

  • Kim, Dong Hwan;Song, Bong Sup;Lee, Jun Ah;Kim, Dong Ho
    • Pediatric Infection and Vaccine
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    • v.19 no.1
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    • pp.1-11
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    • 2012
  • Purpose : Although influenza is regarded as one of the major causes of morbidity and mortality in children with cancer, the actual vaccine coverage remains poor. We conducted evaluation of immunogenicity and safety of influenza vaccine in children with cancer. Methods : In this study, 25 children with cancer who received influenza vaccine (SK influenza IX vaccine$^{(R)}$) at the Korea Cancer Center Hospital between October and December 2009 were analyzed. Blood samples of patients were collected twice (at the beginning of this study and at 30th day after vaccination) and their antibody titers were measured using the hemagglutination-inhibition (HI) assay. Immunogenicity of the influenza vaccine was assessed by seroprotection rate on days 0 and 30, seroconversion rate on day 30, and mean fold increase (MFI) of geometric mean titer (GMT) of HI between days 0 and 30. Results : Any of the subjects in our study did not experienced serious adverse events after influenza vaccination. Seroprotection rates were 68% for H1N1, 40% for H3N2, and 36% for B. Seroconversion rates were 12% for H1N1, 16% for H3N2, and 20% for B. MFIs were 0.9 for H1N1, 1.2 for H3N2, and 1.8 for B. Conclusion : In the study, we found a limited protective immune response to influenza vaccine, among subjects with cancer. However, some subjects showed seroconversion, and there were no severe adverse events among all subjects, supporting the recommendation of annual influenza vaccination in children with cancer.

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The Microbiological Assessment of a University Foodservice Establishment, and Hazard Analysis for Quality Control of Fried Fish Cake Soup Preparation (대학 급식시설의 위생 실태조사 및 품질관리를 위한 연구 - 제 1 보 : 오뎅국을 중심으로 -)

  • Rew, Kyung;Kim, Jeong-Mi;Kwak, Tong-Kyung
    • Journal of Nutrition and Health
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    • v.18 no.4
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    • pp.283-292
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    • 1985
  • A sanitary quality of a university foodservice establishment was assessed in terms of time and temperature, pH and Aw, and microbiological evaluation. Critical control points during various phases in product flow of fried fish cake soup were identified using hazard analysis concept. The results are summarized as follows : 1) Time and temperature data indicated that phases of holding ingredients at room temperature after cooking, and hot - holding of soup before assembly were critical. 2) pH and Aw values were in favorable for microbial growth. 3) Microbiological data indicated that microbial quality of ingredients was in poor condition. A holding practice of cooked ingredients at room temperature might provide the chance for microbial contamination and multiplication. Hot - holding time and temperature of soup should be strictly controlled to assure the food safety, since the microbial quality of serving food can be directly influenced by the hot - holding temperature of soup. 4) Microbiological test results for food containers, equipments, working surfaces, and supplies indicated that sanitary conditions of earthenware, gloves, wiping cloths and cutting board should be improved promptly. 5) Critical control points identified were : ingredients, pre - preparation, post - preparation, and holding before assembly and service. 6) Guidelines for the effective quality control program for this operation were suggested.

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Analysis of Accident Modification Factors (AMF) for Roadway-Rail Grade Crossing Accidents with Baysian Method (베이지안분석을 이용한 철도건널목 Accident Modification Factors (AMF)에 관한 연구)

  • Oh, Ju-Taek;Choi, Jae-Won;Park, Dong-Joo
    • Journal of Korean Society of Transportation
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    • v.22 no.4 s.75
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    • pp.31-42
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    • 2004
  • This study develops Accident Modification Factors (AMF) of countermeasures with Baysian method which are newly proposed for reducing Roadway-Rail grade crossing accidents. This study proposes a new "Bayesian Analytical Framework" for countermeasure assessment which combines "Subjective" Prior Information with "Logical" based Information. The newly proposed "Bayesian Analytical Framework" consists of the following three steps: The 1st step - Countermeasure Selection, Choice of Participants, Selection of Crashes; The 2nd step-Development of Crash History Manual and Countermeasure Evaluation Manual; The 3rd step-Development of AMFs through sound statistical tests. This study used the Komogorov-Smirnov(K-S) Test to determine whether two unknown distribution functions associated with the two populations are identical. The results of the study are that individual responses did not meet the K-S test of identical distributions. while individual vs. group distributions are identical. This indicates that combining the input of several people reduces the impact of individual subjectivity and assumptions and is important for developing a repeatable distribution to develop sound AMFs of countermeasures for reducing Roadway-Rail grade crossing accidents. The procedures of the AMF development conducted in this study can be used to estimate the safety effects of countermeasures for road segments and intersections, in addition to Roadway-Rail grade crossings.

Prediction of Landslides and Determination of Its Variable Importance Using AutoML (AutoML을 이용한 산사태 예측 및 변수 중요도 산정)

  • Nam, KoungHoon;Kim, Man-Il;Kwon, Oil;Wang, Fawu;Jeong, Gyo-Cheol
    • The Journal of Engineering Geology
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    • v.30 no.3
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    • pp.315-325
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    • 2020
  • This study was performed to develop a model to predict landslides and determine the variable importance of landslides susceptibility factors based on the probabilistic prediction of landslides occurring on slopes along the road. Field survey data of 30,615 slopes from 2007 to 2020 in Korea were analyzed to develop a landslide prediction model. Of the total 131 variable factors, 17 topographic factors and 114 geological factors (including 89 bedrocks) were used to predict landslides. Automated machine learning (AutoML) was used to classify landslides and non-landslides. The verification results revealed that the best model, an extremely randomized tree (XRT) with excellent predictive performance, yielded 83.977% of prediction rates on test data. As a result of the analysis to determine the variable importance of the landslide susceptibility factors, it was composed of 10 topographic factors and 9 geological factors, which was presented as a percentage for each factor. This model was evaluated probabilistically and quantitatively for the likelihood of landslide occurrence by deriving the ranking of variable importance using only on-site survey data. It is considered that this model can provide a reliable basis for slope safety assessment through field surveys to decision-makers in the future.

The Correlation Analysis between Dynamic Cone Penetration Test and Plate Loading Test Results for Evaluation of Dam Conditions (제체 상태 평가를 위한 동적 콘 관입시험과 평판재하시험 결과의 상관관계 분석)

  • Jung, Young-Hoon;Kim, Seongmin;Lim, Jeong-yeul
    • Journal of the Korean GEO-environmental Society
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    • v.19 no.4
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    • pp.33-38
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    • 2018
  • The internal erosion due to poor compaction of the material was the main cause of collapse of the embankment in Korea. The assessment of the compaction state of the dam body was a very important check in the safety diagnosis of the embankment. In this study, the correlation between dynamic cone penetration test and plate loading test which is the most typical compaction evaluation technique was analyzed to verify the applicability of the dynamic cone penetration test in evaluating the compaction state of the dam body. The standard penetration tests were carried out six times to define soil properties and depth of the test site. The spatial distributions were obtained by the Kriging method after 15 times of plate loading tests and 47 times of dynamic cone penetration tests. The Pearson correlation coefficient between the spatial distribution of the plate loading test and the dynamic cone penetration test spatial distribution at the constant penetration depth was calculated. The load distribution in the plate loading test and the blow counts at penetration depths of 5 cm, 10 cm and 15 cm in the dynamic cone penetration test showed a weak positive correlation.

Method Validation for Monitoring of Agricultural Worker Exposure to Insecticide Fenthion (살충제 Fenthion에 대한 농작업자 노출 측정을 위한 분석/시험방법 검증)

  • Kim, Eun-Hye;Lee, Hye-Ri;Choi, Hoon;Moon, Joon-Kwan;Hong, Soon-Sung;Jeong, Mi-Hye;Park, Kyung-Hun;Lee, Hyo-Min;An, Xue Hua;Kim, Jeong-Han
    • The Korean Journal of Pesticide Science
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    • v.15 no.4
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    • pp.357-365
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    • 2011
  • Exposure measurement of agricultural worker to pesticide is one of important part of health risk assessment of pesticide. Therefore exposure matrices, apparatus, instruments and methods must be validated in advance to field experiment. In this study, method validation with an organophosphorus insecticide fenthion was carried out for exposure monitoring of agricultural worker. LOD and LOQ were 0.01 and 0.05 ng, respectively. Calibration curve linearity ($R^2$ > 0.999) and reproducibility (C.V. < 3%) were also excellent. Recovery at LOQ, 10LOQ and 100LOQ levels from gloves, socks, mask, patch, solid sorbent, glass fiber filter was 76~113% (C.V. < 3%). Trapping efficiency was 95~105% while no breakthrough was observed. Method validation for the exposure monitoring was established successfully through several experiments. Such method validation can be usually performed in laboratory and not much different for each pesticide so that, this techniques will be applied widely in research for pesticide exposure monitoring by combination with body surface area and respiration rates.