• 제목/요약/키워드: IRB

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Bioequivalence Study of Loxoprofen Sodium in healthy Volunteers (Loxoprofen sodium 제제(레녹스정)의 생물학적 동등성시험)

  • 최주영;유내춘;박민수;김경환
    • Biomolecules & Therapeutics
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    • v.6 no.4
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    • pp.417-422
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    • 1998
  • Loxoprofen sodium (sodium 2-[4-(2-oxocyclopentylmethyl)phenyl] propionate dehydrate) is a nonsteroidal antiinflammatory drug of $\alpha$-phenyl propionic acid derivative. To test the bioequivalence of loxoprofen, the pharmacokinetic parameters of new preparation of loxoprofen, LENOX was compared with LOXONIN as a reference drug. Fourteen healthy volunteers were entered to the stydy (Yonsei University College of Medicine, Severance Hospital IRB approval No. 9608). They were administered 60 mg of loxoprofen in 2$\times$2 cross-over design. There was one week of drug-free interval between doses. The blood sample was taken on schedule up to 8 hours, and the plasma concentration loxoprofen was measured by reverse phase high-performance liquid chromatography (HPLC) with UV-detector. There were no significant difference between two preparations when AUC, Cmax, and Tmax were compared by ANOVA. The mean differences of AUC, Cmax, and Tmax were within 20% of the reference drug: the values were 2.22,5.61, and 12.50%, respectively. The confidence limits of AUC and Cmax but not Tmax satisfied the bioequivalence criteria. These results suggest that the tested LENOX is bioequivalent to the reference drug.

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충적층 지하수의 철, 망간 기작 및 효율적 처리 방안 연구 -강변여과수 개발 현장을 중심으로-

  • 김형수;김충환;김병군;백건하;최현숙
    • Proceedings of the Korean Society of Soil and Groundwater Environment Conference
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    • 2002.09a
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    • pp.125-128
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    • 2002
  • 강변 여과 취수 방식을 활용한 국내 충적층 지하수의 이용을 위해서는 망간에 대한 수처리가 주요 사항인 것으로 나타났다. 강변 여과 방식 취수 원수의 망간 함량은 먹는 물 수질 기준을 부분적으로 상회하지만, 이러한 망간에 대한 저감 처리는 기존의 지표수를 취수하여 처리하는 수처리 공정에 비해서는 상대적으로 효율적인 것으로 판단된다. 실제로, 국내 최초의 강변 여과 방식 취수를 활용하는 창원시 대산 지구 원수는 공기 포기, 급속 여과, 활성탄 여과를 통해, 먹는 물 수질 기준을 상회하는 망간을 효과적으로 처리하고 있는 것으로 평가되었다. 특히, 활성탄 여과가 망간제거 효과를 보이는 점은 특이한 현상으로, 활성탄 내에서도 철 관련 박테리아에 의한 망간 처리 가능성을 시사하고 있다. 또한 망간과 함께 나타나는 철 성분은 망간의 침전 처리에 긍정적인 면으로 작용하는 것으로 판단된다. 한편, 고령군 다산면에서의 실증 플랜트 실험은 전염소처리와 망간접촉여과를 통해 먹는 물 기준 이하의 망간 함량을 확보하는 데는 성공하였으나, 이러한 처리 기작이 안정화되는데 까지는 약 3개월 내외의 시간이 요구되는 것으로 나타났다.

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Study on CAD/CAM Interfacing for Robot based Laser Welding (로봇 레이저용접을 위한 캐드캠 인터페이싱에 관한 연구)

  • Gang, Hui-Sin;Seo, Jeong;Kim, Jeong-O;Park, Gyeong-Taek;Jo, Taek-Dong
    • Proceedings of the KWS Conference
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    • 2007.11a
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    • pp.67-69
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    • 2007
  • Laser welding technology for automobile body is studied. Laser system, robot and seam tracking system are used for 3D laser welding system. The laser system is used 4kW Nd:YAG laser(HL4006D) of Trumpf and the robot system is used IRB6400R of ABB. The seam tracking system is SMRT-20LS of ServoRobot. The welding joints of steel plate are butt and lap joint. The 3 dimensional laser welding for non-linear pipe welding line is performed.

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Development of 3D Laser Welding Technology for Automobile body (자동차 차체 3차원 레이저 용접기술 개발)

  • Jeong, Byeong-Hun;Lee, Mun-Yong;Seo, Jeong;Gang, Hui-Sin
    • Proceedings of the KWS Conference
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    • 2005.06a
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    • pp.103-105
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    • 2005
  • Laser welding technology for automobile body is studied. laser system, robot and seam tracking system are used for 3D laser welding system The laser system is used 4kW Nd:YAG laser(HL4006D) of Trumpf and the robot system is used IRB6400R of ABB. The seam tracking system is SMRT-20LS of ServoRobot. The welding joints of steel plate are butt and lap joint. The 3-D welding for non-linear tailored blank is performed after experiments of bead on plate. Finally, the welding process for non-linear tailored blank is developed.

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Implementation of the Revised Common Rule in the United States and its implications for Human Research in Korea (미국 Common Rule의 주요 개정 내용과 시사점)

  • Choe, Byung In
    • The Journal of KAIRB
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    • v.2 no.1
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    • pp.1-5
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    • 2020
  • The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule, 45 CFR 46, Subpart A). The Common Rule was initially promulgated in 1991 and amended in 2005. The Final Rule to update the current regulations was published in the Federal Register on 19 January 2017. The final compliance date of the revised Common Rule including the cooperative research requirement is effective on 20 January 2020 after twice to delay. The revised Common Rule aims to make more effective conduct of minimal risk research reflecting modern research activities and recognize evolving technologies, including mobile technologies, internet, and the growth in computing power. The revisions to the Common Rule were based on a variety of sources of public, stakeholder, and expert comments. The author summarized the key changes and the implications to Korean human research regulations.

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An Analysis on the Knowledge Levels, Attitudes, and Factors Affecting the Choices of Those Who Completed the Education of Persons Conducting Clinical Trial Workers (의약품 임상시험 종사자 교육 이수자의 지식 수준, 태도, 교육 선택 요인 분석)

  • Lee, Yoon Jin;Jang, Hye Yun;Lee, Yu-Mi
    • The Journal of KAIRB
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    • v.3 no.2
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    • pp.19-27
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    • 2021
  • Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

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Impact on department adaptation of field practice adaptation, college adaptation, and awareness of death of nursing students (간호대학생의 현장실습적응, 대학적응, 죽음에 대한 인식이 학과적응에 미치는 영향)

  • Je, Nam Joo;Park, Meera
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.10
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    • pp.300-312
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    • 2018
  • This study was conducted to identify the impact on department adaptation of field practice adaptation, college adaptation, and awareness of death of nursing students, as well as to establish basic data for adaptation of the major, adaptation to field practice, and measures to raise awareness of death. The subjects of this study were 252 Junior and Senior nursing students living in C, J city. Data were collected after approval from the IRB of C University on April 30, 2018 and analyzed by the mean values, percentages, t-test, ANOVA, Pearson's correlation coefficient and multiple regression using IBM SPSS 21.0. The subjects' field practice adaptation was 3.58, college adaptation was 3.33, awareness of death was 3.15 and department adaptation was 3.38. There were significant correlations between department adaptation and field practice adaptation (r=0.56, p<0.001), negative of death (r=-0.15, p=0.016), respect for life (r=0.33, p<0.001) of nursing students, field practice adaptation and college adaptation (r=0.48, p<0.001) and respect for life (r=0.16, p=0.009) of nursing students and between college adaptation and respect for life (r=0.32, p<0.001) of nursing students. The factors that have effect on the department adaptation of the subjects; As a factor influencing the department adaptation, department adaptation, field practice adaptation, and respect for life were explained by 67.5% (F=171.67, p<0.001). Therefore, a positive attitude toward death and a curriculum related to change in perception must be provided to undergraduates to change the attitude toward death. It is also suggested that research regarding nursing department adaptation effects be conducted after implementing the program to improve respect for life.

Violence Response, Burnout and Job Satisfaction according to Violence Episode of Emergency Room Worker (응급실 종사자의 폭력 경험에 따른 폭력 반응 소진 및 직무 만족)

  • Kim, Mi Yeon;Ha, Tae Uk;Hwang, Yong;Kang, Ji Sook
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.18 no.1
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    • pp.406-416
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    • 2017
  • The purpose of this study was to examine violence response, burnout, and job satisfaction according to violent episodes of emergency room workers. Methods : This Study was a descriptive survey design using convenience sampling. This study was exempt from needing an IRB approval. There were 167 emergency room workers, who agreed to participate in this study, and took a self-report questionnaire between July and August 2015. SPSS 21.0 version was used for descriptive analysis, frequency, percentage, mean, standard deviation, independent t-test, Pearson correlation coefficients, and multiple regression. The major findings of this study were as follows: 1) 84.4% of participant experienced violent episodes. The frequency of verbal violence was highest. Violent attackers were patients and guardians with drunken state. The time of violence episodes was usually during the night. Violent experience of doctors and nurses was very high. 2) There were significant differences in the emotional response according to violent episodes (t=2.528, p=0.12) 3) The correlation between \response and burnout was statistically significant, and indicates a high positive correlation (r=.616, p=<.001). The correlation between violence response and job satisfaction was statistically significant, indicating a negative correlation (r=-.512, p=<.001). There was a negative correlation between burnout and job satisfaction with statistical significance (r=-.568, p=<.001). 4) Significant factors influencing job satisfaction were emotional response to violence and burnout. Conclusion: The findings of this study provide basic information for the strategies of preventing violence, decreasing burnout, and improving job satisfaction by developing a violence management program.

The Mediating Effect of Nurse's Communication on the Relationship between Nursing Needs and Nursing Satisfaction in hospital patients. (입원환자가 인지하는 간호요구도와 간호만족도의 관계에 영향을 미치는 간호사 의사소통 매개효과)

  • Choi, Un Jong;Kang, Ji Sook
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.4
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    • pp.374-382
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    • 2018
  • This study aimed to identify the mediating effect of nurse's communication on the relationship between nursing needs and nursing satisfaction in hospital patients. After IRB approval, this study was performed by administering questionnaires to 180 university hospital patients between April and June, 2017. Collected data were analyzed with SPSS 22.0. The average score of nurse's communication, nursing needs, and nursing satisfaction were $3.88{\pm}0.52$, $3.96{\pm}0.55$, and $3.74{\pm}0.59$ out of 5, respectively. There were significant differences in educational and therapeutic needs versus satisfaction. As for nurse's communication and nursing satisfaction, there were significant differences by patient's room. There were positive correlations among nurse's communication and nursing needs (r=.286, p<.001) as well as nurse's communication and nursing satisfaction (r=.524, p<.001), In addition, there were positive correlations between nursing needs and satisfaction (r=.488, p<.001). Nursing communication had a partial mediating effect between nursing needs and satisfaction, which showed significance in Sobel's test (Z=2.450, p=.014). Therefore, it is suggested that a continuous program for strengthening communication of hospital nurses is needed.

A Study on High Speed Laser Welding by using Scanner and Industrial Robot (스캐너와 산업용 로봇을 이용한 고속 레이저 용접에 관한 연구)

  • Kang, Hee-Shin;Suh, Jeong;Kim, Jong-Su;Kim, Jeng-O;Cho, Taik-Dong
    • Proceedings of the KWS Conference
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    • 2009.11a
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    • pp.29-29
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    • 2009
  • On this research, laser welding technology for manufacturing automobile body is studied. Laser welding technology is one of the important technologies used in the manufacturing of lighter, safer automotive bodies at a high level of productivity; the leading automotive manufacturers have replaced spot welding with laser welding in the process of car body assembly. Korean auto manufacturers are developing and applying the laser welding technology using a high output power Nd:YAG laser and a 6-axes industrial robot. On the other hand, the robot-based remote laser welding system was equipped with a long focal laser scanner system in robotic end effect. Laser system, robot system, and scanner system are used for realizing the high speed laser welding system. The remote laser welding system and industrial robotic system are used to consist of robot-based remote laser welding system. The robot-based remote laser welding system is flexible and able to improve laser welding speed compared with traditional welding as spot welding and laser welding. The robot-based remote laser systems used in this study were Trumpf's 4kW Nd:YAG laser (HL4006D) and IPG's 1.6kW Fiber laser (YLR-1600), while the robot systems were of ABB's IRB6400R (payload:120kg) and Hyundai Heavy Industry's HX130-02 (payload:130kg). In addition, a study of quality evaluation and monitoring technology for the remote laser welding was conducted. The welding joints of steel plate and steel plate coated with zinc were butt and lapped joints. The quality testing of the laser welding was conducted by observing the shape of the beads on the plate and the cross-section of the welded parts, analyzing the results of mechanical tension test, and monitoring the plasma intensity and temperature by using UV and IR detectors. Over the past years, Trumf's 4kW Nd:YAG laser and ABB's IRB6400R robot system was used. Nowadays, the new laser source, robot and laser scanner system are used to increase the processing speed and to improve the efficiency of processes. This paper proposes the robot-based remote laser welding system as a means of resolving the limited welding speed and accuracy of conventional laser welding systems.

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