• Title/Summary/Keyword: institute evaluation

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Preparation of guidance documents item by item for one-step evaluation and approval for Medical Devices (의료기기 일괄허가 및 기술문서 심사를 위한 품목별 길라잡이 개발)

  • Kim, Yong-Woo;Shin, Chae-Min;Bang, Ji-Young;Yi, Jung-Yeon;Oh, Hyeon-Joo;Bae, Woo-Jin;Choi, Jin-Man;Lim, Kyung-Mi;Oh, Heon-Jin;Kim, Mi-Young;Hur, Chan-Hoi;Kim, Hyung-Bum;Choi, Min-Yong;Kwak, Ji-Young;Kim, Su-Yeon;Hwang, Sang-Yeon;Youn, Hae-Suk;Hong, Hye-Kyeong;Ahn, So-Young;Lee, Chang-Hyung;Jeong, Jin-Baek;Koo, Ja-Jung;Kang, Se-Gu;Jung, Jae-Hoon;Lim, Kyoung-Taek;Lim, Chang-Keun;Kim, Min-Su;Lee, Seong-Hyi;Lee, Jae-Keun;Park, Ki-Jung
    • Journal of Biomedical Engineering Research
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    • v.31 no.4
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    • pp.280-284
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    • 2010
  • Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

A Study on the Museum Exhibition Evaluation Methods and the Status of Korean Exhibition Evaluation - Focused on the Case Studies of Korean History Museums & Exhibit Design Firms - (뮤지엄 전시디자인 평가방식 및 현황에 관한 연구 - 한국 역사계 뮤지엄과 전시전문회사의 사례연구를 중심으로 -)

  • 김주연;김성일
    • Korean Institute of Interior Design Journal
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    • no.40
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    • pp.117-125
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    • 2003
  • If the collection of exhibit objects as well as exhibit planning are not in accord with the overall purpose of the exhibit, it will be difficult to attain satisfactory results. The present study focuses on the exhibit evaluation. The exhibit evaluation is very important because it allows the whole process of exhibit development to be reviewed, and it can point a way towards improving the exhibit. Research was conducted by literature review for the museum evaluation methods and by survey for the status of Korean exhibit evaluation. Several Korean History Museum Exhibitions were targeted as cases for this study. Structured and open-ended interviews with 70 museum specialists including curators and exhibit designers were conducted. In conclusion, museum evaluation methods were timely arranged first; front end analysis, second; formative evaluation, third; summative evaluation. Through the survey, one forth of museum specialist didn't have the concept of the exhibit evaluation. However they felt the importance of it.

A Study on the Development of Environmental Indicators and the Evaluation of Environmental Amenity (쾌적환경평가 및 지표개발에 관한 연구 - 경기도를 중심으로 -)

  • 성현찬;이영준
    • Journal of the Korean Institute of Landscape Architecture
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    • v.24 no.4
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    • pp.23-38
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    • 1997
  • In this Study, indicators for the evaluation of environmental amenity were determined through the investigation of the resident's consciousness in all thirty one cities and counties of Kyonggi. Also, environmental amenity that the resident feel in terms of recognition level was evaluated and based on the determined environmental indicators, environmental amenity for the physical environmental situation was evaluated. By analyzing the results, basic data for the planning of the future environmental management were prepared. The results of this study can be summarized as follows First, the developed indicators for the evaluation of environmental amenity consist of four intermediate evaluation items and fifteen individual evaluation items, and fifty four evaluation standards in total . Two to five evaluation standards were determined for the respective individual evaluation items. Second, using the developed indicators, the evaluation of environmental amenity were implemented based on both resident's consciousness and statistical data. Third, by analyzing the difference between two evaluation results, future research plan was proposed.

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The Relation of Attendance Rate and Course Evaluation in Computer Practice Liberal Education (컴퓨터 실습 교양강좌에서 출석률과 강의평가의 관계)

  • Choi, Jin-Ho
    • Journal of the Korea Institute of Information and Communication Engineering
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    • v.17 no.5
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    • pp.1233-1238
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    • 2013
  • The course evaluation is used in faculty evaluation model even the grade of course evaluation has a big gap in absolute value with the characteristics of subjects. It is important to obtain the reliability of course evaluation because the result of course evaluation is fed to instructor to assure the quality of instruction. The purpose of this paper are to analyze the relation of attendance rate and course evaluation to improve the reliability of course evaluation.

An evaluation of uncertainty of random effects with correlation - gravimetric preparation of standard gas - (상관관계가 있는 우연효과에 대한 불확도 평가 - 중량법에 의한 표준가스 제조 -)

  • Choi, JongOh;Kim, Yong-Doo;Kim, Dal-Ho;Kim, Jin-Seog
    • Analytical Science and Technology
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    • v.16 no.1
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    • pp.90-93
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    • 2003
  • The standard uncertainties of two different approaches using the same data set are compared and evaluated using an example of gravimetric standard gas preparation. It is shown that the correlation between input quantities should be taken into account for the proper evaluation of uncertainty resulting from random effects.

Relevance Analysis of Performance Evaluation Systems of Government S&T Research Groups (출연연구기관의 연구회 단위 기관평가제도의 적합성 분석)

  • Nam, Yeong-Ho;Kim, Byeong-Tae
    • Journal of Technology Innovation
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    • v.14 no.3
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    • pp.117-154
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    • 2006
  • This research examines performance evaluatees' opinions regarding the current institutional performance evaluation systems of Government S&T Research Institutes (GRIs). Under the current evaluation systems, twenty GRIs are grouped into three Research Groups and each Group has its own evaluation systems. One problem of the current institutional evaluation systems is that the systems cannot reflect individual GRIs' characteristics. The following methods are used. First, based on four perspectives of Kaplan & Norton(1992)'s Balanced Scorecard(BSC) model, six perspectives appropriate to GRUs' characteristics are derived. Second, experts classify current performance evaluation measures into the six perspectives. This enables different evaluation systems of three GRI Research Groups to be compared under the same evaluation measures. Third, GRIs' evaluatees are asked to allocate appropriate weights on the performance measures. Evaluatees' weights of a GRI are compared with average weights of the related Group. Finally in every BSC's perspective, GRIs that have extraordinarily over-scored or under-scored weights are analyzed in terms of GRIs' missions, customers, capability of human resources, etc. In the Basic Research Group, the Korea Basic Science Institute is deviated in the financial perspective and the strategic direction perspectives. In the Public Research Group, Korea Institute of Construction Technology is significantly different from other GRIs in three perspectives. Five out of eight GRIs in the Industrial Research Group, GRIs are significantly different each other in several perspectives. It could be concluded that the current institutional evaluation systems are least appropriate in measuring performance of the GRIs of the Industrial Research Group.

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A Study on Purge Gas Inflow according to Valve Operation Sequence during Staged Combustion Cycle Engine Reignition Test (다단연소 사이클 엔진 재점화 시험 시 밸브 작동순서에 따른 퍼지가스 유입에 대한 연구)

  • Hwang, Changhwan;Lee, Jungho;Kim, Chaehyeong;Jeon, Jun-Su;Park, Jae-Young;Lee, Kwang-Jin;Cho, Nam-Kyung;Kim, SeungHan;Han, Yeoungmin
    • Journal of the Korean Society of Propulsion Engineers
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    • v.26 no.4
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    • pp.64-71
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    • 2022
  • For the development of an improved upper-stage engine, research on a staged combustion cycle liquid rocket engine is in progress. A cold flow test, ignition test, and combustion test plans were established and performed to develop reignition combustion technology. In order to solve the problem of purge gas flowing into the fuel line, which may cause cavitation in the turbo pump during reignition, the test results of each stage were analyzed. Based on the analysis results, the purge gas inflow problem was solved by reducing the overlapping time between the operation of the bubble removal valve and the opening of the purge valve and the engine fuel valve. Based on this, the reignition combustion test was successfully performed.

Simultaneous determination of illegal galactagogue adulterants in supplement diets by LC-MS/MS

  • Lee, Ji Hyun;Cho, So-Hyun;Park, Han Na;Park, Hyoung Joon;Kim, Nam Sook;Park, Sung Kwan;Kang, Hoil
    • Analytical Science and Technology
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    • v.31 no.4
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    • pp.171-178
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    • 2018
  • Recently, for successful lactation, many breastfeeding mothers seek various products, including herbal medicine, dietary supplements, and prescribed medicines, to improve milk production. As demand for galactogogues grows, it is highly possible that pharmaceutical galactogogues may be adulterated with illegal products to maximize their efficacy. For continuous control and supervision of illegal products, we developed and validated a simple and sensitive LC-MS/MS method capable of simultaneously determining five galactogogues. Chromatographic separation was conducted using an Agilent Poroshell $120SB-C_{18}$ column with a mobile phase consisting of 20 mM ammonium formate (pH 5.4) and 100 % acetonitrile. The total run time was 13 min per analyte. The proposed method was performed according to the guidelines of the International Conference of Harmonization and it produced reliable results. This method showed high sensitivity and specificity, with a limit of detection (LOD) and limit of quantitation (LOQ) of 0.01-0.82 ng/mL and 0.02-2.45 ng/mL, respectively, for the solid- and liquid-type samples. Specificity was evaluated by analyzing matrix-blank samples spiked with the target compounds at LOQ levels, which provided a good separation of all peaks without interference. Additionally, the repeatability and intermediate precision were typically <15 %, whereas the recovery was 80-120 % of the values obtained using blank samples. Thus, we concluded that this method could be used for the identification and quantification of galactogogues in food or herbal products.

Application and Validation of an Optimal Analytical Method using QuEChERS for the determination of Tolpyralate in Agricultural Products (QuEChERS법을 활용한 농산물 중 제초제 Tolpyralate의 최적 분석법 선발 및 검증)

  • Lee, Han Sol;Park, Ji-Su;Lee, Su Jung;Shin, Hye-Sun;Kim, Ji-Young;Yun, Sang Soon;Jung, Yong-hyun;Oh, Jae-Ho
    • Korean Journal of Environmental Agriculture
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    • v.39 no.3
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    • pp.246-252
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    • 2020
  • BACKGROUND: Pesticides are broadly used to control weeds and pests, and the residues remaining in crops are managed in accordance with the MRLs (maximum residue limits). Therefore, an analytical method is required to quantify the residues, and we conducted a series of analyses to select and validate the quick and simple analytical method for tolpyralate in five agricultural products using QuEChERS (quick, easy, cheap, effective, rugged and safe) method and LC-MS/MS (liquid chromatography-tandem mass spectrometry). METHODS AND RESULTS: The agricultural samples were extracted with acetonitrile followed by addition of anhydrous magnesium sulfate, sodium chloride, disodium hydrogencitrate sesquihydrate and trisodium citrate dihydrate. After shaking and centrifugation, purification was performed with d-SPE (dispersive-solid phase extraction) sorbents. To validate the optimized method, its selectivity, linearity, LOD (limit of detection), LOQ (limit of quantitation), accuracy, repeatability, and reproducibility from the inter-laboratory analyses were considered. LOQ of the analytical method was 0.01 mg/kg at five agricultural products and the linearity of matrix-matched calibration were good at seven concentration levels, from 0.0025 to 0.25 mg/L (R2≥0.9980). Mean recoveries at three spiking levels (n=5) were in the range of 85.2~112.4% with associated relative standard deviation values less than 6.2%, and the coefficient of variation between the two laboratories was also below 13%. All optimized results were validated according to the criteria ranges requested in the Codex Alimentarius Commission (CAC) and Ministry of Food and Drug Safety (MFDS) guidelines. CONCLUSION: In conclusion, we suggest that the selected and validated method could serve as a basic data for detecting tolpyralate residue in imported and domestic agricultural products.

Development and Validation of a Simultaneous Analytical Method for the Detection of Mefentrifluconazole and Triticonazole Fungicide in Agricultural Crops (농산물 중 메펜트리플루코나졸 및 트리티코나졸 살균제의 동시 분석법 개발 및 검증)

  • Park, Ji-Su;Lee, Han Sol;Lee, Su Jung;Shin, Hye-Sun;Shim, Jae-Han;Yun, Sang Soon;Jung, Yong-hyun;Oh, Jae-Ho
    • Korean Journal of Environmental Agriculture
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    • v.39 no.2
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    • pp.130-137
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    • 2020
  • BACKGROUND: Mefentrifluconazole and triticonazole are the triazole fungicides. The maximum residue levels for agricultural products need to be set up. Therefore, development of the official analytical method for determination of mefentrifluconazole and triticonazole residues from agricultural crops was necessary due to safety management, and then a simultaneous analytical method was developed for the determination of mefentrifluconazole and triticonazole in agricultural crops. METHODS AND RESULTS: Samples were extracted using acetonitrile and purified using dispersive solid phase extraction, and then detected with liquid chromatograph-tandem mass spectrometry (LC-MS/MS). Matrix-matched calibration curves (0.0025-0.25 ㎍/mL) were linear into a sample extract with r2>0.99. For validation, the recovery test was carried out at three fortification levels (LOQ, 10 LOQ and 50 LOQ) from agricultural samples. The results for mefentrifluconazole and triticonazole ranged between 92.3 to 115.3% and 91.4 to 108.5%, respectively and RSD (relative standard deviation) values were also below 6.0%. Furthermore, inter-laboratory was conducted to validate the method. CONCLUSION: All values were corresponded with the criteria ranges requested by both the CODEX (CAC/GL 40-1993, 2003) and MFDS guidelines (2016). Therefore, the proposed method can be used as an official analytical method for determination of mefentrifluconazole and triticonazole (triazole fungicides) in the Republic of Korea.