• Title, Summary, Keyword: Research and Developmen

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National Strategic Planning For Facilitating the Development of New Drugs in the Korea Food and Drug Administration (국내 신약개발 촉진을 위한 식약청의 국가연구개발 사업 전략수립)

  • Kim, Jong-Wook;Kwon, Kwang-Il;Yoo, Kwang-Soo;Park, So-Hyun;Lim, Chul-Joo;Choi, Don-Woong
    • Journal of the Korean Applied Science and Technology
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    • v.25 no.4
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    • pp.539-555
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    • 2008
  • It is well understood that developing new drugs is one of the highest value-added businesses in a country; however, the current governments' spending in pharmaceutical research and development(R&D) is minimal in Korea. This paper suggests that different governmental bodies should take in charge of different stages of the R&D process in order to maximize the use of limited government research funding. First, during the initial phase of the drug development, including clinical trials, the Ministry of Education, Science and Technology is the most appropriate governmental organization to support the research. For later procedures such as supporting the industries for exporting developed drugs, legislative approvals, and building infrastructure for future clinical trials should be supported by the Ministry of Knowledge and Economy and the Ministry of Health and Welfare along with the Korea Food and Drug Administration(KFDA). The KFDA, which is the main governmental agency approving newly developed drugs in the market, will need to take a crucial responsibility in the initial phase of the pharmaceutical R&D by guiding the industries with timely and proper information. As a first step, it is recommended to set up and operate a center for supporting new drugs, so that the industries can facilitate the development of marketable drugs which meet customers' needs. Later, in order to expedite the process of exporting and getting approvals of the newly developed drugs from foreign countries, it is necessary to develop new approval system, which includes introduction of the Good Manufacturing Practice (GMP), mandatory validation system, and education program for supporting expertise. Lastly, the KFDA needs to take an active role in developing Korean pharmaceutical industries by communicating with other foreign governments with regards to the globalization of the Korean pharmaceutical industries. For example, as a follow up after the Free Trade Agreement(FTA), active discussion on GLP of Mutual Recognition Agreement(MRA) with the United States of America, should be seriously considered.

Expression of Proapoptotic Bcl-2 Family Member in the Mouse Ovary (I) (생쥐 난소에서 Bcl-2계 세포고사인자에 관한 연구 (I))

  • Lee, Yu-Il;Lee, Jin;Chun, Sang-Young
    • Clinical and Experimental Reproductive Medicine
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    • v.30 no.1
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    • pp.47-55
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    • 2003
  • Objectives: Bok, Bcl-2-related ovarian killer, is a proapoptotic Bcl-2 family protein identified in the ovary based on its dimerization with the antiapoptotic protein Mcl-1. The present study examined the hormonal regulation and localization of Bok messenger RNA levels in the mouse ovary during the follicle development. Methods: The animals were implanted subcutaneously with Silastic brand capsules containing the synthetic estrogen, DES at $21{\sim}23$ days of age. Ovaries were collected $1{\sim}3$ days after implantation for RNA analysis and in situ hybridization. Some mice were removed capsule for $1{\sim}2$ days to induce ovarian follicle apoptosis. Ovaries were also collected from 26 day-old immature mice at various times after treatment with 10 IU PMSG. Some mice received a single intraperitoneal injection of 10 IU hCG to induce ovulation, and ovaries were obtained at different time intervals for Northern blot and in situ hybridization analysis, respectively. Results: Treatment of immature mice with diethylstilbestrol (DES) for $24{\sim}48$ h increased ovarian Bok mRNA levels. Bok mRNA was remained the same levels in mice removed DES for $24{\sim}48$ h to induce apoptosis. High signals of Bok mRNA after DES treatment were detected in granulosa cells of early antral follicles. Treatment of immature mice with PMSG for 12 h increased markedly ovarian Bok mRNA expression which was detected mainly in preantral and atretic follicles. Interestingly, low levels of Bok mRNA were also expressed in granulosa cells of preovulatory follicles. Treatment of PMSGprimed mice with hCG stimulated strongly ovarian Bok mRNA expression at $6{\sim}9$ h. At that time, Bok mRNA was expressed in granulosa cells of atretic and small growing follicles. Conclusion: These results demonstrate that Bok is one of proapoptotic Bcl-2 members expressed in early growing and atretic follicles during the ovarian follicular development. Gonadotropins induce a transient increase of Bok gene expression in granulosa cells of preantral and preovulatory follicles indicating some role in the ovulatory process.

An Importance Analysis of National Competency Standard for 4-year College Information Systems Development Curriculum (국가직무능력표준(NCS)의 4년제대학 정보시스템개발 교육과정을 위한 중요도분석연구)

  • Kim, Jae Kyung
    • Journal of the Korea Industrial Information Systems Research
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    • v.22 no.4
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    • pp.117-129
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    • 2017
  • The Purpose of this Study is to Identify the Learning Modules of the National Competency Standard (NCS) Related to the Information Systems Development Curriculum of 4-year Colleges, to Explore the Possibility of Applying NCS to the Curriculum, and to Examine Implications. The Importance of 26 Competency Units in the Applied SW Engineering of NCS was Compared by Area Experts Composed of 14 Information Systems Developers and Professors of 7 Universities who Teach Software Engineering Subjects Through the Hierarchical Analysis Process (AHP). The Results of the Study as Follows. First, the Relative Importance of the Competency Elements was in order of 'Confirming the Requirements', 'Checking the UI Requirements', 'Designing the Physical Data Repository', 'Testing Developer Integration', and 'Fixing Developer Defects'. Second, while the Entry and Intermediate Level Developer Group Determined that the Competency Elements Related to the IS Development Implementation Stage is more Important, the Advanced IS Developer Groups Consider the Competency Elements Related to the Theory-oriented Design Stage as Important Competency. In Addition, the Group of College Professors was Found to Choose all the Practical and Theoretical Competency Elements that Two Developers Groups Considered Important. Implications of the Study Suggested that the Job Performance Competence and Quality of Education Related to IS Development can be Enhanced.