• Title/Summary/Keyword: comprehensive inspection

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Comparison of Current GCPs on the Basis of the Contents in ICH-GCP (ICH-GCP와 선진 각국의 GCP 비교)

  • 박혜연
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 1997.11a
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    • pp.57-74
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    • 1997
  • To make a proposal for the revision of KGCP, ICH Harmonized Tripartite Guideline for Good Clinical Practice, which is on the stage of worldwide implementation, was compared with current GCPs of tripartite countries of ICH, namely USA, Europe and Japan as well as Korea. On the basis of the classification in ICH GCP, comprehensive comparisons among the corresponding articles of 4 regions or countries were made in the order of IRB / IEC, Investigator, Sponsor and Clinical Trial Protocol. Based on the comparisons of the contents in ICH-GCP with those in current GCPs, major suggestions for the revision of current KGCP can be made as follows. Firstly, the function of IRB / IEC needs to be strengthened for the initiation and continuation of clinical trial. Current 2-step approval system of IRB / IEC and Health Authorities requires to be converted into the system similar to that of developed countries. Secondly, sponsor's obligation needs to be tightened to control and assure the quality of clinical trial. Inspection of regulatory authorities should be made to perform during and / or after clinical trial, when it is necessary. In other words, sponsor should be made to establish written Standard Operating Procedures (SOPs) for all aspects of clinical trial including monitoring to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement (s). Besides, the provision of ‘Quality Control and Quality Assurance’ should be added to the protocol to establish the credibility of the result of the clinical trial.

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Facility Maintenance Management System Using a Mobile Application (모바일 어플리케이션을 이용한 시설물 유지관리 시스템)

  • Joo, Young-Do
    • The Journal of the Korea institute of electronic communication sciences
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    • v.7 no.5
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    • pp.1145-1151
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    • 2012
  • Recently, the demand for mobile system is growing owing to the spread of smart phones to enable the real-time business process. This paper proposes the real-time facility maintenance management system using an android-based mobile application to apply to the facility defect/maintenance field for the apartment building complex. The proposed system model aims to develop the comprehensive management system to integrate the web and mobile system to lead to the realization of mobile office. The security measures required in the mobile system are technically analyzed and implemented on the system.

Comprehensive Evaluation of Water-Reservoir Measuring Equipment for Highway Safety Analysis (도로 노면 안전성 분석을 위한 물고임 측정장비 개발 및 현장 적용성 연구)

  • Lee, Jin Kak;Yun, Duk Geun;Joh, Young-Oh
    • International Journal of Highway Engineering
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    • v.15 no.3
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    • pp.127-135
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    • 2013
  • PURPOSES : The purpose of this study is development of automatic equipment to measure the road water-reservoir which can be one of factors for road traffic safety inspection and its application to safety analysis. METHODS : The scopes of this study are the examination of the riskiness and location of road water-reservoir through literature review, development of appropriate sensor and automatic equipment to survey the road water-reservoir and evaluation of field application. RESULTS: The laser lighting and IR camera were selected to develop the equipment. It was found from the field calibration that there is a high correlation between rutting and road water-reservoir and road water-reservoir caused by rutting can be correctly calculated. About 20.2km of national highway were inspected for case study and field application. It was found from correlation of traffic incident that 2.08km of the latent length for water-reservoir which is related to 12 traffic incidents were analyzed. CONCLUSIONS : This technique can be utilized evaluation method for road condition such as road water-reservoir for conventional evaluation system such as road traffic safety assessment and safety analysis and it can be use to new evaluation system to apply various road condition and traffic condition.

The Corelation Analysis between Condition Evaluation Factors and Defect Index on the Concrete Retaining Wall (콘크리트 옹벽에 대한 상태평가 항목과 결함지수와의 상관관계 분석)

  • Seong, Joo Hyun;Byun, Yoseph;Lee, Dong Yul;Oh, Tae Keun
    • Journal of the Korean Society of Safety
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    • v.30 no.5
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    • pp.52-58
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    • 2015
  • Although lots of safety inspection and precision safety diagnosis have been conducted on concrete retaining wall, there is no comprehensive analysis on the basis of the accumulated data associated with the statistic. Especially, the concentrated management is necessary on the evaluation items that cause critical damages for the efficient performance. In this regard, this study conducted a correlation analysis between the 18 condition evaluation items and defect index for the concrete retaining wall as well as how each item affects the final defect index as much as in the manual. As a result, correlation coefficient between sliding and overturning was 0.601, which means that they have a strong correlation, and the most influential item on defect index is the condition of drainage that scored the 0.750 correlation coefficient. In addition, as a result of regression analysis, the condition of drainage with the 0.683 correlation coefficient has a strong correlation with the defect index. If the condition evaluation items are integrated or readjusted based on the results of the statistical analysis in this study, the more efficient and accurate maintenance will be possible.

Roles of Housing Management Support Center and Short-and Long-Term Development Plan (공동주택관리지원센터의 역할과 장단기 발전방안 연구)

  • Eun, Nan-Soon;Kwak, Do;Chae, Hae-Won;Jee, Eun-Young
    • Journal of the Korean housing association
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    • v.26 no.6
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    • pp.169-180
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    • 2015
  • This study was carried out to offer direction to the Housing Management Support Center in terms of its key features and specific operational tasks. The research involved the property management office (n=35) and Resident Representatives of the apartment blocks (n=52). Advisory Services conducted a consumer survey, as well as a survey of expert interviews (n=15). Survey results were as follows: (1) the Managing Director and secretary residents were satisfied with the Diagnosis and Advisory services; (2) the administrative support services need to address housing issues, including a long-term repair plan and advice on using long-term repair reserves and "conflict resolution associated with public housing management"; and (3) there was a greater need for a "basic, common-sense Housing Management Information Base to provide services to the Resident Representatives of the apartment blocks". Based on the survey results, the main roles of the Housing Management Support Center are to act as a House of Commons Administrator to handle complaints with counseling, diagnosis and advice; to support the Resident Committees; to provide professional training, research, and investigation; to support community revitalization; to manage the business of guidance and inspection; to coordinate conflicts and disputes; to build a comprehensive source of information; and to build networks.

Effects of Metformin on Breast Cancer Risk and Mortality in Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis (제 2형 당뇨병 환자의 유방암 발생 위험 및 사망률에 대한 메트포민의 영향: 체계적 문헌고찰 및 메타분석)

  • Chun, Pusoon
    • Korean Journal of Clinical Pharmacy
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    • v.25 no.3
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    • pp.131-137
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    • 2015
  • Background: The protective effect of metformin against breast cancer is inconclusive. Objective: To evaluate the effect of metformin on breast cancer risk and mortality in patients with type 2 diabetes. Method: A comprehensive literature search was performed for pertinent articles published prior to June 30, 2014, using PubMed and EMBASE. Study heterogeneity was estimated with $I^2$ statistic. The data from the included studies were pooled and weighted by random-effects model. The quality of each included study was assessed on the basis of the 9-star Newcastle-Ottawa Scale and publication bias was evaluated by visual inspection of a funnel plot. Results: Ten studies were included in the meta-analysis of the association of metformin and breast cancer risk. By synthesizing the data from the studies, the pooled odds ratio (OR) was 0.72 (95% CI: 0.59, 0.87) (p = 0.0005). Three cohort studies were included for meta-analysis of the association between metformin and breast cancer-related mortality. Metformin was associated with a significant decrease in mortality (Risk ratio: 0.68; 95% CI: 0.51, 0.90, p = 0.007). Conclusion: The present meta-analysis suggests that metformin appears to be associated with a lower risk of breast cancer incidence and mortality in patients with type 2 diabetes.

Demonstration of EPRI CHECWORKS Code to Predict FAC Wear of Secondary System Pipings of a Nuclear Power Plant

  • Lee, Sung-Ho;Seong Jegarl;Chung, Han-Sub
    • Nuclear Engineering and Technology
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    • v.31 no.4
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    • pp.375-384
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    • 1999
  • The credibility of CHECWORKS FAC model analysis was evaluated for plant application in a model plant chosen for demonstration. The operation condition at each pipe component was defined before the wear rate analysis by plant data base, water chemistry analysis, and network flow analysis. The predicted wear was compared with the measured wear for 57 sample components selected from 43 susceptible line groups analysed. The inspected 57 locations represent components of highest predicted wear in each line group. Both absolute value and relative ranking comparisons indicated reasonable correlations between the predicted and the measured values. Four components showed much higher measured wear rates than the predicted ones in the feed water train from main feed water pump discharge to steam generator, probably due to high hydrazine concentration operation the effect of which had not been incorporated into the CHECWORKS model. The measured wear was higher than the predicted one consistently for components with least susceptibility to FAC. It is believed that the conservatism maintained during UT data analysis dominated the measurement accuracy. A great deal of enhancement is anticipated over the current plant pipe management program when a comprehensive plant pipe management program is implemented based on the model analysis.

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Improving Diesel Car Smoke Measurement Probe Performance of Diesel Cars Using Hole Position (홀 위치에 따른 디젤자동차 매연 측정프로브 성능 개선 연구)

  • Chae, Il-Seok;Kim, Eun-Ji;Kim, Jae-Yeol
    • Journal of the Korean Society of Manufacturing Process Engineers
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    • v.19 no.1
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    • pp.29-35
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    • 2020
  • Car inspection systems are regularly carried out by the state to ensure the safety and emission status of cars, thereby improving the safety and quality of life by reducing fine dust and greenhouse gases that are the main culprits of vehicle defects and air pollution. These automobile inspections are largely divided into either regular or comprehensive inspections. This study analyzed the smoke measuring probes used in the lug - down 3 mode. In the previously issued paper "Improvement of Soot Probe Efficiency for Automotive Emission Measurement," an improved smoke measurement probe(B) improved on the problems that arise from the current smoke measurement probe (A). In this study, a technique that can improve the probe's inhalation efficiency over the improved (B) probes was applied to probes (C). Probe (C) involves a structure designed close to the center of the circumference of the exhaust pipe, and the suction efficiency was improved by adding a variable center unit.

The STCW Manila Amendments and its Challenges to the Far East

  • Chae, Chong-Ju
    • Journal of Navigation and Port Research
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    • v.38 no.3
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    • pp.193-202
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    • 2014
  • The comprehensive review of the STCW 1978, as amended in 1995 and associated Code was carried out from 2006 to 2010. These amendments will have a certain degree of impact on Maritime Education and Training(MET) institutes in terms of education and training of seafarer worldwide. Particularly, the Far East region countries are effected more than other regions since they covered about 30% of officers and 37% ratings in the world. In view of these facts this dissertation conceived to analyze the problems in the Far East main seafarer supply countries faced the implementation of "STCW Manila Amendments" To analyze these problems, this dissertation carried out questionnaire research to 7 targeted main MET of major Far East seafarer supply countries. After research this dissertation suggests the possible solutions such as, Joint On-Board Training Center; Joint Asia Maritime E-learning Systems; methods to reducing work-load, ship inspection burden and determine mandatory minimum safety manning standards in a safe way; technical cooperation fund to installation of training equipment; and clarify vague terminology of STCW Manila Amendments, to solve problems identified through the questionnaires.

Design of a Robust Position Tracking Controller with Sliding Mode for a 6-DOF Micropositioning Stage (6자유도 정밀 스테이지의 추종제어를 위한 슬라이딩 모드 제어기 설계)

  • Moon, Jun-Hee;Lee, Bong-Gu
    • Journal of the Korean Society of Manufacturing Technology Engineers
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    • v.20 no.2
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    • pp.121-128
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    • 2011
  • As high precision industries such as semiconductor, TFT-LCD manufacturing and MEMS continue to grow, the demand for higher DOF precision stages has been increasing. In general, the stages should accommodate a prescribed range of payloads in order to position various precision manufacturing/inspection instruments. Therefore a nonlinear controller using sliding motion is developed, which bears mass perturbation and makes the upper plate of the stage move in 6 DOF. For the application of the nonlinear control, an observer is also developed based on expected noise covariance. To eliminate the steady state error of step response, integral terms are inserted into the state-space model. The linear term of the controller is designed using optimization scheme in which parameters can be weighted according to their physical significance, whereas the nonlinear term of the controller is designed using trial and error method. A comprehensive simulation study proves that the designed controller is robust against mass perturbation and completely eliminates steady state errors.