• Title/Summary/Keyword: reference standard

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Bioequivalence Evaluation of Two Brands of Zolpidem Tartrate 10 mg Tablets(Zanilo and Stilnox) in Healthy Male Volunteers

  • Ryu, Ju-Hee;Lee, Heon-Woo;Lee, Hyun-Su;Kang, Il-Mo;Seo, Ji-Hyung;Kang, Jin-Yang;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.36 no.5
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    • pp.343-348
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    • 2006
  • The purpose of the present study was to evaluate the bioequivalence of two zolpidem tartrate tablets, Stilnox tablet(Sanofi-aventis Korea, reference product) and Zanilo tablet(ChoDang Pharm Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration(KFDA). After adding an internal standard(cimetropium), 250 ${\mu}L$ plasma samples were extracted using 1.3 mL of ethyl acetate. Extracted compounds were analyzed by HPLC with triple-quadrupole mass spectrometry. This method for determination of zolpidem is proved accurate and reproducible with the limit of quantitation of 1 ng/mL in human plasma. Twenty-four healthy male Korean volunteers received each medicine at the zolpidem tartrate dose of 10 mg in a $2{\times}2$ crossover study. There was one-week washout period between the doses. Plasma concentrations of zolpidem were monitored for over a period of 8 hr after the administration. $AUC_{0-t}$(the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$(maximum plasma drug concentration) and $T_{max}$(time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_{0-t}$ and $C_{max}$. No significant sequence effect was found for all of the bio-availability parameters indicating that the crossover design was properly performed. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25(e.g., log 0.92-log 1.06 for $AUC_{0-t}$, log 0.96-log 1.13 for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zanilo tablet is bioequivalent to Stilnox tablet.

A Study on Selecting Geospatial Framework Data Using Factor Analysis (요인분석을 이용한 기본공간정보 선정에 관한 연구)

  • Choe, Byong Nam;Lee, Ji Hun;Park, Jin Sik;Kang, In Gu
    • Spatial Information Research
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    • v.23 no.5
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    • pp.53-64
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    • 2015
  • Several countries have built National Spatial Data Infrastructure (NSDI) for information sharing among various fields. One of the important factors of NSDI is framework data, which is the most commonly used geospatial data across various fields. Previous studies on the framework data suggest components based on frequency survey and case study. However, such research methods do not have objectivity in setting the components of the framework data. This research uses factor analysis with 104 medium-level layers from the most widely used National Base Map and 5 layers from the other sources including cadastre and aerial image. Each layer is scaled with usage level as four different patterns of 1) background data, 2) reference data, 3) base data, and 4) other data, respectively. The analysis results show that the layers are grouped into 5 to 7 factors according to the patterns. ANOVA reveals that the mean differences between the factors with high values and the other factors with low values under each pattern are statistically significant. Such high value factors under each pattern consist of similar layers, close to identical, with those under the other categories. This research proposes framework data system, including transportation, building, hydrography, elevation, administrative district, digital orthoimagery, geodetic control, and cadastral based on the analysis results. Proposed framework in this research will be a basis of establishing spatial data sharing system. For sharing proposed framework data in various fields, these data must be established and distributed as actual standard and also related future researches should be performed.

The Patterns of the PM Air Quality Guidance Level in Seoul during 1990~2000 (서울시 대기관측망을 중심으로 부유분진 기준농도 초과자료를 이용한 시공간적 경향성 비교 연구)

  • Choi, Ye-Jin;Kim, Min-Young;Kim, Ki-Hyun
    • Journal of the Korean earth science society
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    • v.24 no.3
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    • pp.190-204
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    • 2003
  • The PM (particulate matter) concentration data sets exceeding the Daily Air Quality Guidance Levels (i.e., established by the Korean Ministry of Environment) were selected from 31 air qality monitoring stations in Seoul from 1990 to 2000. (For reference, the 24hr environmental standard values of PM$_{10}$ and TSP are 150 and 300${\mu}$g/m$^{3}$, respectively.) When the data sets were compared between land use types, both PM fractions were exceeded most frequently in residential areas. However, the highest TSP concentration was measured at industrial areas (351.0${\pm}$35.9${\mu}$g m$^{3}$), while the highest PM$_{10}$ concentration was measured in residential areas (182.9${\pm}$42.4${\mu}$g m$^{3}$). When the temporal distribution patterns of the exceedance data sets were compared to those measured routinely (without any discrimination based on exceedance criteria), large differences were present. It was demonstrated that the occurrences of exceedance data sets increased rather significantly in recent years.

A Study on Property with Ratio of Water Mixture in Hydroponic Polyurethane Waterproofing Materials (수경화성 폴리우레탄 도막 방수재의 물 혼합비에 따른 물성변화연구)

  • Park, Jin-Sang;Park, Wan-Goo;Kim, Dong-Bum;Lee, Min-Kyu;Oh, Sang-Keun
    • Journal of the Korean Recycled Construction Resources Institute
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    • v.3 no.4
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    • pp.348-354
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    • 2015
  • Urethane waterproofing materials which currently being used most commonly in the Korean domestic market have high applicability and construct layers without forming any joints, but under the influence of low temperature and low humidity, as well as the thickness of the applied layer, the curing time of this material may become extended in construction sites. To resolve these issues, a proposed method of using water-hardening type of polyurethane waterproofing materials are being developed. However, there currently lacks any standards or evaluation methods on determining an optimal mixture ratio of water for the water-hardening polyurethane waterproofing materials. Therefore, workers and construction workers are relying on their hands-on-skills and experience to determine this ratio and are not able to obtain a consistent performance quality out of these materials. Therefore, for the establishment of a board applicability of the water-hardening polyurethane waterproofing methods in construction sites, this study objectively analyzes the changes in the performance of these materials depending on the changes of the water mixture ratio and attempts to procure the optimal ratio on the basis of forming a provisionary standard. The study prepares mixtures of varying ratio(no water added, 5, 10, 15, 20, 25, 30, 40 and 50) and conducts comparative analysis respective mixtures' performances and their changes in the physical properties in an objective manner and proposes a provisional optimal value that can serve as a data base that can be used as a reference for future studies.

Influence of diameter, length, and platform shape of implant fixture on the stress distribution in and around the screw type implant (나사형 임플란트 고정체의 길이, 직경, 플랫폼 형태에 따른 임플란트와 주위조직의 응력분포)

  • Kang, Ji-Eun;Chung, Hyun-Ju;Ku, Chul-Whoi;Yang, Hong-So
    • Journal of Dental Rehabilitation and Applied Science
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    • v.18 no.4
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    • pp.277-288
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    • 2002
  • Seven finite element models were constructed in mandible having single screw-type implant fixture connected to the premolar superstructure, in order to evaluate how the length, diameter and platform shape of a screw-type fixture influence the stress in the supporting tissue around fixtures. Each finite element model was varied in terms of length, diameter, and platform shape of the fixture. In each model, 250N of vertical load was placed on the central pit of an occlusal plane and 250N of oblique load placed on the buccal cusp. The stress distribution in the supporting tissue and the other components was analysed using 2-dimensional finite element analysis and the maximum von Mises stress in each reference area was compared. Under lateral loading, the stress was larger at the abutment/fixture interface, and in the crestal bone, compared to the stress pattern under vertical loading. The amount of stress at the superstructure was similar regardless of the length, diameter and platform shape of a fixture. Around the longer fixture, the stress was decreased at the bone crest and subjacent cancellous bone and increased in the cancellous bone area apical to the fixture. Around the wider fixture, the stress was decreased at the abutment/fixture interface, and the bone crest and increased in the cancellous bone area apical to the fixture. Around the fixture having wider platform, less stress was produced at the abutment/fixture interface and the upper part of the cortical bone, compared to the fixture having standard platform. In conclusion, the stress distribution of the supporting tissue was affected by length, diameter, and platform shape of a fixture, and the fixture which was larger in diameter and length could reduce the stress in the supporting tissues at the bone-fixture interface and bone crest area.

A Study on the Performance of Noise Level and Airflow Amount of a Kitchen Hood by the Different Conditions of Airflow Path. (레인지후드 덕트설치 조건에 따른 소음 및 풍량특성 연구)

  • Kim, Il-Ho;Kim, Youn-Jae;Lee, Yong-Jun;Lee, Kyu-Dong
    • Proceedings of the Korean Institute of Building Construction Conference
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    • 2007.11a
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    • pp.11-14
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    • 2007
  • Noise level and Airflow amount of a kitchen hood are affected by the conditions of airflow path. Thus this study is expected to be used as a basic reference in designing airflow path of apartment housing throughout analysing changes in noise level and airflow amount from the various conditions of airflow path. Noise level generated by the kitchen hood is estimated in a kitchen and a living room of two constructed apartment houses, and an experiment is conducted in an half anechoic chamber to analyze noise level and airflow amount by the different length, diameter and number of windings of a round shaped soft duct which is connected to the kitchen hood. The measured results in apartment houses show that the noise level in both apartments exceeds the NC standard greatly in living spaces. In apartment A, a regular apartment house, the noise level was $NC-65{\sim}75$, $NC-45{\sim}60$ and NC-70, NC-45 in the kitchen and living room with an operation of kitchen hood in 1 and 3 stages. In apartment B, an apartment complex, the noise level was NC-55 and NC-60 in the kitchen and living room with an operation of kitchen hood in 3 stages. In particular, there was an increase of noise level at 125Hz-band resulted from an amplification of sound, which requires adequate measures in noise reduction. The results measured in Half anechoic chamber show 99% of airflow amount increase with the modification of a duct' s diameter from ${\Phi}$ 100mm to ${\Phi}$ 125mm, 37% of airflow amount increase with the modification of a duct' s diameter from ${\Phi}$ 125mm to ${\Phi}$ 150mm, and 173% of airflow amount increase with the modification of a duct' s diameter from ${\Phi}$ l00mm to ${\Phi}$ 150mm. The noise level was lower than the level measured in apartment housing about 20 in NC-value and 11.4 in dB(A)-value, which was interpreted as the effect of the load by the pressure condition at the rear end of the duct. Also, an amplification of sound in 125Hz-band influenced NC-value considerably, therefore effective measure is needed.

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A Study on Improvement of Modular Specifications - Focused on technical specifying method in waterproof and mechanical works - (모듈러 공사시방서 개선방안에 관한 연구 - 방수 및 기계설비공사의 기술방안 개선을 중심으로 -)

  • Yoon, Jongsik;Shin, Dongwoo;Cha, Heesung;Kim, Kyungrai
    • Korean Journal of Construction Engineering and Management
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    • v.18 no.3
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    • pp.33-41
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    • 2017
  • A modular specification is a contract document that specifies the requirements of production, transformation and installation in a modular construction. A problem of the currently used specification is that it does not guarantee the level of performance required by the modular construction and fails to accommodate unique characteristics of each construction because it widely uses the standard specification as it is. This study proposes a specification that reflects the unique feature of modular construction in order to improve the quality of modular construction. Research focuses on the leakage in waterproof and mechanical equipment because it is the area with the highest rate of defects. This study suggests ways to improve the modular specification as follows: 1)Descriptive specifying (following MasterFormat) 2)Propose leakage verification method and test clause 3) Reflect characteristic of modular construction. Proposed modifications to modular specification are reviewed by experts for validation and their opinion verifies suggested improvements as a way to secure the quality of modular construction and to promise characteristics of the modular specification. This improvement will be used for reference when writing construction project specification, which can be an important contract document, so that it could lower occurrence rate of the modular defects.

A Study on the Comparison of Methods for the Measurement of Hydrocarbon Dew Point of Natural Gas (천연가스의 탄화수소 이슬점 측정방법 비교 연구)

  • Lee, Kang-Jin;Ha, Young-Cheol;Her, Jae-Young;Woo, Jin-Chun;Kim, Yong-Doo;Bae, Hyun-Kil
    • Korean Chemical Engineering Research
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    • v.53 no.4
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    • pp.496-502
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    • 2015
  • Hydrocarbon dew point(HCDP), a property which is the most generally used for describing natural gas condensation, is a very important parameter of natural gas quality specifications. HCDP is strongly influenced by the concentration of the heavier hydrocarbon components, especially $C_6+$, so, along with compliance with gas quality specifications, build up of procedures for obtaining accurate HCDP is essential for gas transmission company, because hydrocarbon condensation present may cause serious operational and safety problems. This study has been carried out in an attempt to measure HCDP accurately by the automatic hydrocarbon dew point meter under the actual field conditions. Measured HCDP also has been compared with calculated HCDP using the composition determined by gas chromatograph and industry accepted equation of state at multiple pressures, along with the cricondentherm. The test results are 1) the automatic hydrocarbon dew point meter was able to measure stable HCDP continuously 2) the automatic hydrocarbon dew point meter has been performed reference measurement by pure propane with a known dew point from literature, and 3) A meaningful differences was observed when comparing the automatic hydrocarbon dew point meter and gas chromatograph results for synthetic standard gas mixtures and real gas mixtures.

Evaluating MRV Potentials based on Satellite Image in UN-REDD Opportunity Cost Estimation: A Case Study for Mt. Geum-gang of North Korea (UN-REDD 기회비용 산정에서 위성영상 기반의 MRV 여건평가: 금강산을 사례로)

  • Joo, Seung-Min;Um, Jung-Sup
    • Spatial Information Research
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    • v.22 no.3
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    • pp.47-58
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    • 2014
  • The credible measurement, reporting and verification (MRV) is among the most critical elements in UN-REDD (United Nations programme on Reducing Emissions from Deforestation and forest Degradation in Developing Countries). This study is intended to explore MRV potential in terms of UN-REDD opportunity cost estimation using satellite image for Mt. Geum-gang of North Korea. A visual interpretation were conducted to evaluate MRV conditions by sub-dividing or decomposing the images with different pixel size into a three types of hierarchical tree structure that helps dealing with spatial variability within each subarea. The permanent record of standard satellite remote sensing system demonstrated its capability of presenting area-wide visual evidences of MRV conditions in Mt. Geum-gang (such as the identification of forested area, degradation trends for forest space, three types of hierarchical land-cover and land use tree structure, carbon density in the landscape). Satellite data could be accepted as legally binding proof when it comes to REDD opportunity cost estimation since several cases exist where remote sensing has been used as legal evidence in ICJ (International Court of Justice) and UN resolution. It doesn't seem very difficult to comply with MRV requirements for UN-REDD opportunity cost calculation due to the probative value of satellite data. It is anticipated that this research output could be used as a valuable reference for Korea-based enterprises exploring REDD project sites and the carbon traders to ensure MRV potentials using satellite image in UN-REDD Opportunity Cost estimation.

Evaluation of LA-ICP-MS Whole Rock Trace Element Analysis Using Fused Glass Bead of Silicate Rocks (규산염 암석의 알칼리 용융 유리원판에 대한 LA-ICP-MS 전암 미량원소 분석법 평가)

  • Kim, Myong Jung;Kim, Taehoon;Park, Kye-Hun;Lee, Ye Ji;Yang, Yun Seok;Moon, Jeongjin
    • The Journal of the Petrological Society of Korea
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    • v.24 no.2
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    • pp.141-147
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    • 2015
  • Using laser-ablation inductively coupled plasma mass spectrometry (LA-ICP-MS), we evaluated the reliability of trace element abundance data measured from the silicate rock references of JR-3, JG-3, JGb-1 and JB-1b using glass discs made by alkali fusion. For 28 elements including rare earth elements, relative standard deviations (RSD) are better than 7% in case when the concentrations of the elements in the rock samples are greater than 10 ppm. However, RSD shows somewhat increased values for the concentrations less than 10 ppm, but never exceeds 25%. Compared with previously reported averages of the compiled abundance data, our data display satisfactory results for the most cases with differences less than 10%. We suggest that LA-ICP-MS analysis using fused glass beads is a reliable, precise and time-saving method of trace element analysis for the silicate rocks spanning from mafic to felsic compositions.