• Title/Summary/Keyword: Procedure Quality

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Development and Validation of an HPLC Method for the Pharmacokinetic Study of Dipyridamole in Human (디피리다몰 체내동태 연구를 위한 혈청 중 디피리다몰의 HPLC 정량법 개발 및 검증)

  • Cho, Hea-Young;Kang, Hyun-Ah;Moon, Jae-Dong;Choi, Hoo-Kyun;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.36 no.1
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    • pp.45-51
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    • 2006
  • A rapid, selective and sensitive reversed-phase HPLC method for the determination of dipyridamole in human serum was developed, validated, and applied to the pharmacokinetic study of dipyridamole. Dipyridamole and internal standard, loxapine, were extracted from human serum by liquid-liquid extraction with diethyl ether and analyzed on a Nova Pak $C_{I8}$ column with the mobile phase of 40 mM ammonium acetate:methanol:acetonitrile (35:35:30)(v/v/v, pH 7.8). Detection wavelength of 280 nm and flow rate of 1.0 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^3$ factorial design using a fixed dipyridamole concentration (50 ng/mL) with respect to its peak area and retention time. And also, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of 2-2000 ng/mL with correlation coefficients greater than 0.999. The lower limit of quantification using 0.5 mL of serum was 2 ng/mL, which was sensitive enough for pharmacokinetic studies of dipyridamole. The overall accuracy of the quality control samples ranged from 103.94 to 105.86% for dipyridamole with overall precision (% C.V.) being 4.60-11.49%. The relative mean recovery of dipyridamole for human serum was 97.64%. Stability studies showed that dipyridamole was stable during storage, or during the assay procedure in human serum. The peak area and retention time of dipyridamole were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of dipyridamole in human serum samples for the pharmacokinetic studies of orally administered Dimor tablet (75 mg as dipyridamole) at three different laboratories, demonstrating the suitability of the method.

Development and Validation of HPLC Method for Pharmacokinetic Study of Promethazine in Human (염산프로메타진 체내동태 연구를 위한 혈청 중 프로메타진의 HPLC 정량법 개발 및 검증)

  • Cho, Hae-Young;Kang, Hyun-Ah;Lee, Hwa-Jeong;Choi, Hoo-Kyun;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.36 no.1
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    • pp.23-29
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    • 2006
  • A rapid, selective and sensitive reversed-phase HPLC method for the determination of promethazine in human serum was developed, validated, and applied to the pharmacokinetic study of promethazine. Promethazine and internal standard, chlorpromazine, were extracted from human serum by liquid-liquid extraction with n-hexane containing 0.8% isopropanol and analyzed on a Capcell Pak CN column with the mobile phase of acetonitrile-0.2 M potassium dihydrogen phosphate (42:58, v/v, adjusted to pH 6.0 with 1 M NaOH). Detection wavelength of 251 nm and flow rate of 0.9 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^{3}$ factorial design using a fixed promethazine concentration (10 ng/mL) with respect to its peak area and retention time. In addition, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of 1-40 ng/mL with correlation coefficients greater than 0.999. The lower limit of quantification using 1 mL of serum was 1 ng/mL, which was sensitive enough for pharmacokinetic studies. The overall accuracy of the quality control samples ranged from 96.15 to 105.40% for promethazine with overall precision (% C.V.) being 6.70-11.22%. The relative mean recovery of promethazine for human serum was 63.54%. Stability (freeze-thaw and short-term) studies showed that promethazine was stable during storage, or during the assay procedure in human serum. However, the storage at $-80^{\circ}C$ for 4 weeks showed that promethazine was not stable. Extracted serum sample and stock solution were not allowed to stand at ambient temperature for 12 hr prior to injection. The peak area and retention time of promethazine were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of promethazine in human serum samples for the pharmacokinetic studies of orally administered Himazin tablet (25 mg as promethazine hydrochloride) at three different laboratories, demonstrating the suitability of the method.

Development and Evaluation of an Automated Stainer for Mycobacterium Tuberculosis (결핵균 자동염색기의 개발 및 평가)

  • Kim, S. C.;Kang, S. I.;Kim, S. C.;Hwang, J. H.;Kim, S. Y.;Kim, Y.;Song, S. D.;Cho, S. N.;Kim, D. W.
    • Journal of Biomedical Engineering Research
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    • v.23 no.3
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    • pp.235-241
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    • 2002
  • The detection of tubercle bacilli (TB) from sputum smear is one of the fast and inexpensive methods for diagnosis of tuberculosis. For this method. sputum smears are usually flexed by heating and stained by acid-fast staining method, and then examined under an optical microscope. Two Procedures are commonly used fur TB staining. One is hot staining and the other is cold staining method. The Ziehl-Neelsen method which is a hot staining method is widely used in Korea because its stained color is more vivid However, the conventional automated stainer has to fix the sputum smear on a slide manually and the stain is not so vivid because it has not heating function. In an effort to save labor and minimize variations in manual staining Procedure. we developed an automated stainer with heating function. The entire staining process is fully automated. from fixation to final washing and drying. With the automated methods, five slides can be flexed and stained in 21 minutes at consistent high quality We compared the concordance rate between the two methods for 91 sputum samples to validate the stain quality of the developed automated stainer. As the results, the concordant rate between the two methods was 95% and there was no significant difference (p>0.05)

The Performance of the National Authorization System of Private Qualification (강건설계방법을 활용한 창의적 문제해결 실습과정)

  • Kim, Tai-Oun
    • Journal of Engineering Education Research
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    • v.11 no.1
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    • pp.64-75
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    • 2008
  • A new product development and product realization process (PRP) is a circulating and feedback process by generating ideas through creative problem solving process. The early stages of PRP correspond to conceptual design and product development, in which a large portion of product life cycle cost can be saved. The optimal design method for this stage is a robust design suggested by Taguchi. Quality must be 'engineered in' since it can not be 'inspected out.' A robust design is an engineering methodology to improve the quality of a product by minimizing the efforts of variations without eliminating the causes. The objective of this study is to propose a scheme and a case study of robust design for exploring design parameters, and introduce a creative problem solving process. Major research subjects include a creative problem solving process, robust design procedure and their implementation. For the experiment of Taguchi method, a toy catapult is adopted. For the creativity development, a short project is assigned to devise a similar tool with the toy catapult. A reference model is suggested to compare and evaluate their ideas.

Dynamic Computed Tomography based on Spatio-temporal Analysis in Acute Stroke: Preliminary Study (급성 뇌졸중 환자의 시공간 분석 기법을 이용한 동적 전산화 단층 검사: 예비 연구)

  • Park, Ha-Young;Pyeon, Do-Yeong;Kim, Da-Hye;Jung, Young-jin
    • Journal of radiological science and technology
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    • v.39 no.4
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    • pp.543-547
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    • 2016
  • Acute stroke is a one of common disease that require fast diagnosis and treatment to save patients life. however, the acute stroke may cause lifelong disability due to brain damage with no prompt surgical procedure. In order to diagnose the Stroke, brain perfusion CT examination and possible rapid implementation of 3D angiography has been widely used. However, a low-dose technique should be applied for the examination since a lot of radiation exposure to the patient may cause secondary damage for the patients. Therefore, the degradation of the measured CT images may interferes with a clinical check in that blood vessel shapes on the CT image are significantly affected by gaussian noise. In this study, we employed the spatio-temporal technique to analyze dynamic (brain perfusion) CT data to improve an image quality for successful clinical diagnosis. As a results, proposed technique could remove gaussian noise successfully, demonstrated a possibility of new image segmentation technique for CT angiography. Qualitative evaluation was conducted by skilled radiological technologists, indicated significant quality improvement of dynamic CT images. the proposed technique will be useful tools as a clinical application for brain perfusion CT examination.

Comparison of ACFAS method and DNPH-LC method for quantitative analysis of formaldehyde in Drinking water (자동연속흐름-흡광광도법과 DNPH-LC법에 의한 먹는물 중 포름알데히드 정량분석 비교)

  • Yi, Geon-Ho;Yun, In-Chul;Kim, Yeong-Kwan;Kim, Chong-Chaul;Choi, Geum-Jong;Lee, Teak-Soo
    • Journal of Korean Society of Water and Wastewater
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    • v.27 no.6
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    • pp.827-836
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    • 2013
  • Due to the stringent drinking water quality, formaldehyde will be included in Korean drinking water standard from year 2014. However, its standard analytical method has not yet been established. This study compares two analytical methods, DNPH-LC and ACFAS with respect to their analysis principles, Method Detection Limit (MDL), Limit Of Quantitation(LOQ), precision, accuracy, reproducibility, convenience, number of samples analyzed per hour and analysis cost. These methods measure absorption intensity at 360 nm by using HPLC after DNPH-derivatization (DNPH-LC) and at 410 nm by using Automated Continuous Flow Absorption Spectrophotometer (ACFAS), respectively. Reproducibility was tested by repeating the analysis 7 times using a standard solution for each method. For DNPH-LC method, MDL was $0.5{\mu}g/L$, LOQ was $1.58{\mu}g/L$ with standard deviation of $0.16{\mu}g/L$. For ACFAS method, they were $0.27{\mu}g/L$, $0.85{\mu}g/L$L with standard deviation of $0.09{\mu}g/L$, respectively. Both methods satisfied the requirement set by the Korean drinking water quality standard. Complexity of sample pretreatment procedure for DNPH-LC method may cause large error and, consequently, the analytical result will depend on the level of skill of analyst. In contrast, ACFAS method which used only one reagent equipped with an automated injection device showed little analytical error. It costs about $5.00 and $1.00 for one sample to analyze by the DNPH-LC method and the ACFAS method, respectively. Compared to the DNPH-LC method, ACFAS method provided more reliable analytical results. In terms of convenience, easiness and analytical cost, ACFAS method was demonstrated to be superior to the DNPH-LC method. The results of this study suggested that the ACFAS method could be adapted as a proper method for determining formaldehyde content in drinking water.

Verification of Spatial Resolution in DMC Imagery using Bar Target (Bar 타겟을 이용한 DMC 영상의 공간해상력 검증)

  • Lee, Tae Yun;Lee, Jae One;Yun, Bu Yeol
    • Journal of the Korean Society of Surveying, Geodesy, Photogrammetry and Cartography
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    • v.30 no.5
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    • pp.485-492
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    • 2012
  • Today, a digital airborne imaging sensor plays an important role in construction of the numerous National Spatial Data Infrastructure. However, an appropriate quality assesment procedure for the acquired digital images should be preceded to make them useful data with high precision and reliability. A lot of studies therefore have been conducted in attempt to assess quality of digital images at home and abroad. In this regard, many test fields have been already established and operated to calibrate digital photogrammetric airborne imaging systems in Europe and America. These test fields contain not only GCPs(Ground Control Points) to test geometric performance of a digital camera but also various types of targets to evaluate its spatial and radiometric resolution. The purpose of this paper is to present a method to verify the spatial resolution of the Intergraph DMC digital camera and its results based on an experimental field testing. In field test, a simple bar target to be easily identified in image is used to check the spatial resolution. Images, theoretically designed to 12cm GSD(Ground Sample Distance), were used to calculate the actual resolution for all sub-images and virtual images in flight direction as well as in cross flight direction. The results showed that the actual image resolution was about 0.6cm worse than theoretically expected resolution. In addition, the greatest difference of 1.5cm between them was found in the image of block edge.

Establishing Risk Management Process for Improved Business Value of a Multi-Purpose Building Project (복합 시설 프로젝트의 사업 가치 향상을 위한 리스크 관리 프로세스 구축 방안)

  • Lee, Jong-Sik;Cho, Seung-Ho
    • Journal of the Korea institute for structural maintenance and inspection
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    • v.22 no.1
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    • pp.64-71
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    • 2018
  • Project Management Institute of America separates the types of risk with external risks and internal risks. The external risk is an uncontrollable risk in projects such as changes of policy and related systems, climate, natural disasters, exchange rates and so on. The internal risk is an existing risk in the project itself that is controllable items in the project. Technical risks in project management are cost, quality, time, safety and environment. Therefore, both the external and internal risks should be managed to perform the construction project successfully. In particular, we can secure the quality and safety of facilities through the technical risk management. The importance of potential risk management has been emerging as a major interest and the lack of risk management delays projects and increases construction costs with negative effects of the building safety since the complex building, which is composed of a great number of facilities, consists of many project units and there are conflicts between various participants and stake-holders. This study presents the ways of establishing risk management processes to ensure the safety of the complex building. To that end, establishing procedure of risk management processes is presented and types of risk and factors in construction projects and counter strategies are presented as available risk information on the stages.

A Study on the Preventive Education for Adolescents′s Problems in Home Economic Education (II) - Adolescents′Culture Analyzed with Newspaper Articles Concerning Adolescents - (가정과 교육에서의 청소년문제 예방교육을 위한 기초 연구 (II) -청소년관련 신문기사분석을 통해 본 청소년 문화 -)

  • 배영미
    • Journal of Korean Home Economics Education Association
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    • v.10 no.2
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    • pp.131-144
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    • 1998
  • The lack of characteristical understanding of the Home Economics Education will have difficulty in achieving the goal of the Home Economics Education. To allow the Home Economics Education class in school contribute toward the enhancement of the quality of life, it is inevitable to reinforce the recognition of the importance and necessity of the Home Economics Education and to newly propose a directional guidance forward the coming 21st century. The purpose of this study was to provide basic data for planners of the future Home Economics Education by surveying research administrators in charge of programming the overall school curriculum. This study was conducted under the following procedure to have the outcome as follows ; 1. Answers from respondents of age over 50 or careers over 16 years tended to grasp the goal of Home Economics Education in relation to the enhancement of quality of life rather than to the accumulation of knowledge, skill or capacity. 2. Of all the surveyed, 9.64% regarded Home Economics Education as an essential part of school education and the positive ratio was higher with younger respondents. 3. To the question asking if the high school Home Economics Education could have influence on one's capacity, 97.2% of the answerers said yes. The respondents with career under 15 year showed 100% of positive agreement in this matter and of age under 40 marked much higher ratio of 98.84% than the elders. 4. The overall recognition of the necessity for separate sections in Home Economics Education programmed in accordance with the 6th Revision of High School Curriculum displayed a considerably high ratio, with a little differences among age and job groups. The purpose of this study is to analyze and understand adolescents'culture, thereby to provide fundamental information for Preventive Education for Adolescents'Problems in Home Economic Education. 745 articles collected in computer communication service were used for the analysis. The data were analyzed by frequency and percentage using the SPSS/PC+computer program. The most important results of this study were as follows ; 1) Concerning 'Adolescent's Problems's, problems such as violence, homicide and robbery were treated with the greatest frequency. It was also analyzed that the older generations are highly inclined to understand adolescents'culture as a negative one, for example, 'delinquency'or 'immaturity'. 2) Although the area of 'Adolescents'Education'was treated most frequently reflecting the high educational concern in our society, the significant part of those articles were on wrongful educational administration. As much as 70.6% of the articles analyzed were on 'Education'and 'Problems'. Thereby it may be concluded that the other areas such as health, activities, worries, values and harmful environments ere treated respectively as only a 'subculture'or'fragmentary culture'. The articles containing correlations and interactions among them and certain alternative proposals were very rare. 3) The areas such as 'Worries and Counselling'and 'Health'were occupying only a small portion of the articles. The articles which were treating the practical worries and their resolutions were even rarer. 4) 'Values'of the adolescents tended to be viewed by the older generations very negatively. It was also found that the older generations gave the tendency to see the 'consumption culture'of the adolescents as a kind of 'counter culture'or'subculture'.

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Development of a Data Reference Model for Joint Utilization of Biological Resource Research Data (생물자원 연구데이터의 공동 활용을 위한 데이터 참조모델 개발)

  • Kwon, Soon-chul;Jeong, Seung-ryul
    • Journal of Internet Computing and Services
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    • v.19 no.4
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    • pp.135-150
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    • 2018
  • The biological resources research data around the world are not only very critical themselves but should be shared and utilized. Up to now, the biological resources have been compiled and managed individually depending on the purpose and characteristics of the study without any clear standard. So, in this study, the data reference model would be suggested which is applicable in the phase ranging from the start of the construction of the information system and which can be commonly used. For this purpose, the data model of the related information system would be expanded based on the domestic and foreign standards and data control policy so that the data reference model which can be commonly applicable to individual information system would be developed and its application procedure would be suggested. In addition, for the purpose of proving the excellence of the suggested data reference model, the quality level would be verified by applying the Korgstie's data model evaluation model and its level of data sharing with the domestic and foreign standards would be compared. The test results of this model showed that this model is better than the conventional data model in classifying the data into 4 levels of resources, target, activities and performances and that it has higher quality and sharing level of data in the data reference model which defines the derivation and relation of entity.