• 제목/요약/키워드: Development Guideline

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생식 · 발생독성시험의 방법적 고찰과 최신 연구 동향 (The Recommended Approaches and Recent Trends in Reproductive and Developmental Toxicology)

  • 곽승준;조대현
    • Toxicological Research
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    • 제21권4호
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    • pp.271-278
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    • 2005
  • Reproductive and developmental toxicology is concerned with various physical or chemical agents interfering with fertility in both gender or normal growth of offsprings. Reproductive and developmental toxicology is rather a complex science, with many fields, i.e., various endpoints are involved and many different mechanisms of action. For that reason, diverse aspects must be considered when attempting to assess possible adverse health effects in the area of reproductive and developmental toxicology. The thalidomide tragedy made it clear to regulatory authorities around the world that systematic, comprehensive evaluation of the reproductive cycle was needed to adequately evaluate the potential of medicinal drugs to impair the process of reproduction or the development of embryos, fetuses, and children. International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) and U.S. Food and Drug Administration (FDA) developed a guideline to assess the reproductive and developmental toxicity. Also these guidelines have since been applied to the detection and regulation of environmental toxicants, food additives, and so on. Although it was hoped that testing procedures of guideline would be updated constantly to reflect the current state of the science in reproductive and developmental toxicology, it was not until this decade that regulatory guidelines and testing methods have been altered in a significant way. In this paper, we would like to present the recommended approaches and recent trends for improvement of testing guidelines or experimental methods in reproductive and developmental toxicology.

영구자석바퀴를 이용한 벽면 이동로봇의 설계치침에 의한 이동체 개발 (Development of mobile vehicle designed by the guideline of wall-climbing mobile robot using permanent magnetic wheels)

  • 한승철;이화조;김은찬
    • 한국정밀공학회:학술대회논문집
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    • 한국정밀공학회 2003년도 춘계학술대회 논문집
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    • pp.1676-1681
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    • 2003
  • The attachment of mobile vehicle is necessary for the automated operation on the inclined or vertical walls of steel structures. Since the vehicle requires attaching devices additionally, its overall efficiency can be reduced by the devices. Therefore, external shapes of mobile vehicles have to be researched to give the effective movement on the vertical face. For the design of mobile vehicle, the guideline has been derived from the modeling of wall-climbing, so that the vehicle should have a specific external shape for vertical movement due to the gravitational force. Hence, some adequate arrangement of attaching device to the mobile vehicle has been presented for the effective movement. In the experiments with four permanent magnetic wheels, a plausible result was achieved as a vertical attaching force of 185.2(N), a friction force of 153.8(N) and a curvature radius of 1.4m. The mobile vehicle should be modified according to the proposed design guideline. and then it could be applied to a specific operation as an appropriate external shape. Also, Further research is recommended on an optimal posture and a moving method in a specific application. as the attaching force ortho vehicle can be affected by its posture.

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유럽공동체 국가들의 환경정책에 관한 연구 -환경영향평가제도를 중심으로 비교분석 (A Study on the Environmental Policy Community Countries in European A Comparative Analysis of Environmental Impact Assessment)

  • 조해용;강순국
    • 한국환경과학회지
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    • 제6권4호
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    • pp.293-302
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    • 1997
  • Environmental problems emerged as common global Problems awaiting solution. Active collaborative efforts are required of nations and communities In order to solve environmental problems effectively. International collaboration occurs much more commonly these days than before. and European Community(EC) mumber countries are no exceptions. EC has established and executed the five-year programs on Environmental Policy Implementation, which explicated basic principles for enoronmental policy development, stance 1973. EC programs tend to emphasize that the direction of the policies should reflect a change from a remedial approach to a preventive approach. Those pro- grams have brought an awareness of the Importance of Environmental Impact Assessment(EIAI to EC member countries. France Installed an EIA system In 1976, which was the first among member countries. Several other member countries also established a system. EC decided that a common guideline was necessary. and therefore formulated the "European Community Guideline for Environmental Impact Assessment" In 1985. All member countries were required to legislate an EIA system within three years, according to the Guideline. This study will conduct a comparative analysis of the current EIA systems of different EC member counties. The findings of this study will provide helpful Information on how to Improve the efficacy of the Korean system.an system.

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한국형 우울증 임상진료지침 개발(II) (Korean Clinical Practice Guideline for the Treatment of Depressive Disorder(II))

  • 강이헌;김수영;이민수
    • 생물정신의학
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    • 제13권4호
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    • pp.219-225
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    • 2006
  • Depression has been causing huge direct and indirect losses to people's health because of its high prevalence, various clinical patterns, drug reaction and diverse courses different among individuals, but its treatment has not been systematic but dependent on individual clinicians' experience and knowledge. To correct this problem, it has been highly necessary to develop clinical guidelines defined as "systematically developed statements to assist practitioners' and patients' decisions about appropriate healthcare for specific clinical circumstances." Currently, countries throughout the world are making efforts to establish evidence-based guidelines among different levels of guidelines and to evaluate and test them. Although such efforts have been unsatisfactory in Korea because of several constraints including lack of high-quality RCT, the Korean Depression Clinical Practice Guideline has started to develop evidence-based guidelines, which are established through strictly designed processes. Thus, the present study purposed to review methods adopted in the development processes and to present the processes of developing the evidence-based guidelines clearly and transparently.

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전자 기록물 이관 절차 개발에 관한 연구 (A Study on Development of Guidelines for Transferring Electronic Records)

  • 오삼균;김희섭;오상훈;권도윤;원선민
    • 한국문헌정보학회지
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    • 제42권4호
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    • pp.441-461
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    • 2008
  • 본 연구의 목적은 국내 기록관리 관련기관들이 전자기록물 이관의 실제 업무에서 효율적으로 사용할 수 있는 실무에 초점을 둔 이관 절차의 개발에 있다. 이 연구의 목적을 달성하기 위하여 ISO, AHDS, CCSDS와 같은 국외의 다양한 이관 절차를 분석하고, 국내 정부부처 중 한 기관을 테스트베드 대상으로 선정하여 국내의 기록물 이관업무에 요구되는 사항들을 조사 분석하고, 이를 종합하여 국내 상황에 적합한 이관절차를 개발하여 제안하였다. 개발된 절차는 사례연구와 다양한 국제 사실상 표준들의 분석을 토대로 도출되었다는 점에서 의의를 갖는다.

태양광 패널 설치를 고려한 건축 디자인 지침 개발 연구 (A Study on the Building Design Guideline Development Considering Photovoltaic Panel Installation)

  • 문창호
    • 대한건축학회연합논문집
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    • 제21권4호
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    • pp.139-146
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    • 2019
  • The purpose of this study is to propose the building design guideline considering photovoltaic panel installation through the analysis of relevant guidelines from home and abroad in terms of building design and solar panel installation. Conclusions can be summarized as followings; Considerations in building design : selection of the site with high solar accessibility, avoidance of the shade from the adjacent building & trees, south facing orientation of solar panel in building design, removal of shade on the solar panel from the part of building itself, load consideration of solar panel & fixing materials, safe passage securement for solar system maintenance, and planning of piping and mechanical room for solar system. Considerations in solar panel installation : harmonizing of solar panel with surrounding environment, unity of solar panel orientation & slope, regular maintenance of solar system, (in case of flat roof installation) solar panel installation afloat over the roof, installation area within the roof floor, and lower than parapet height, (in case of sloped roof installation) solar panel installation parallel with the roof slope, ventilation space securement below the panel, installation area within the roof surface, and similar material installation in empty space.

미국 FAA 신체검사 기준 및 AME 보수교육 변화동향: 한국과의 비교 (US FAA Physical Examination Standards and Amendment of AME Conservation Education: Comparison with Korea)

  • 김영효
    • 항공우주의학회지
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    • 제28권3호
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    • pp.52-55
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    • 2018
  • The purpose of the aviation physical examination guideline is not only to determine the physical fitness of the aviation workers but also to treat the underlying diseases of the aviation employees effectively and to carry out the optimal aviation duties. As medical science advances, treatment guidelines for various diseases are rapidly changing, and aviation physical examination guidelines need to be revised accordingly. Therefore, it is necessary to analyze the change trends of the AME guideline around the world and appropriately reflect it according to the situation of Korea. It is also necessary to continue the training of AME who are required to carry out examinations and certificates by these revision guidelines. Therefore, it would be desirable to analyze the education system of the advanced countries including the US and introduce the advantages of these systems into Korean AME education curriculum. Primarily, with the development of the Internet, various online lectures have been developed recently. Therefore, we first aimed to look at the changes in the current AME guideline of the Federal Aviation Administration. Next, we aimed to discuss changes in the course of the AME refresher course. Finally, we would like to suggest some points to be improved by comparing these AME guidelines and educational programs with those of Korea.

결장직장암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 대조군 임상시험 고찰 (Analysis of Existing Guidelines and Controlled Clinical Trials for Development of [Guideline of Clinical Trials with Herbal Medicinal Products for Colorectal Cancer])

  • 박은주;성신;김성수;김진성;박재우;고석재;한가진
    • 대한한의학회지
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    • 제40권1호
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    • pp.124-152
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    • 2019
  • Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer" by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal products for colorectal cancer that have already been developed. Then, clinical trials for colorectal cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the regulations and guidelines of the Ministry of Food and Drug Safety in order to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicinal products were searched on the national institution homepage. In addition, 12 articles were searched using a combination of the following search terms: 'colorectal neoplasms', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'medicine, East Asian medicine', 'medicine, Kampo', etc. Results: The characteristics of participants were various, such as people with medical histories of surgeries or recurrent cancers or who complained of chemotherapy-induced side effects. The types of interventions were also various and included decoctions, powders, intravenous fluids, intraperitoneal injections and gargles. Comparators used included placebos and conventional treatments. The outcome measurements used in the studies were quality of life, symptom score, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for colorectal cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer".

마오쩌둥 이후 중국 지역 발전 전략의 전환: 불균등 발전에서 권역 협업 기반의 조화로운 발전으로의 진화 (Transformation of Strategies for Chinese Regional Development in the Post-Mao Era: From Regional Uneven To Regionally Coordinated Development In China)

  • ;이승철
    • 한국경제지리학회지
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    • 제26권4호
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    • pp.359-374
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    • 2023
  • 본 연구의 목적은 마오쩌둥 이후 중국 지역 발전 정책의 진화와 공간 불균등과의 관계를 분석하고자 하는 것이다. 이를 위해 본 논문은 1인당 GRDP 변동계수와 지니계수를 적용하여 중국 31개 시·성·자치구 간 지역 경제력 격차와 지역 발전 정책과의 관계를 분석하였다. 중국의 지역 간 경제력 격차는 1979년 이후 심화되었다가 제10차 5개년 계획(2001~2005년) 이후 중부, 서부, 동북부 지역의 지속적인 정부 주도의 대규모 경제성장 정책에 따라 완화되는 것으로 분석되었다. 그러나 이는 31개 시·성·자치구 전체를 대상으로 분석한 결과이며, 동부, 중부, 서부, 동북부 4대 지역을 대상으로 GDP 변동계수를 각각 분석했을 때 상이한 결과가 나타났다. 예를 들어, 제10차 5개년 계획 이후 중부 지역 내 격차는 지속적으로 심화되었지만 서부와 동북부의 지역 내 경제력 격차는 지속적으로 완화되었다. 이는 중국의 지역 간 경제력 격차를 완화시키는데 큰 역할을 한 것으로 분석되었다. 특히 동부 지역 내 격차는 제12차 5개년 규획(2010~2015년) 이후에도 지속적으로 심화되어 중국 지역 경제력의 수렴 현상이 둔화되는 결과를 가져왔다. 이는 제11차 5개년 규획(2006~2010년) 시기에 본격적으로 시행되었던 중부 권역 발전 정책의 한계에 기인한 것으로 볼 수 있다.

국가 수준의 학교도서관 장서관리지침서 개발에 대한 연구 (A Study on Development of a National Collection Management Guideline for the School Library)

  • 이승길;송기호
    • 한국문헌정보학회지
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    • 제51권3호
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    • pp.23-44
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    • 2017
  • 본 연구의 목적은 단위 학교도서관에서 장서관리정책을 수립할 때 근거 및 기준으로 삼을 수 있는 국가 수준의 학교도서관 장서관리지침서에 포함할 구체적인 항목과 내용 요소를 개발하는 것이다. 이를 위하여 학교도서관 장서관리 관련 문서를 국제 수준 및 국가 수준으로 나누어 분석하였다. 분석 결과 해외 장서관리지침서에서는 장서의 양적 기준 이외에 디지털 정보자원에 대한 접근성과 자원 공유를 강조하고 있으며, 이의 제기 자료에 대한 처리 절차를 규정하고 있는 것으로 나타났다. 본 연구에서는 국가 수준의 학교도서관 장서관리지침서가 포함해야 할 항목을 크게 장서관리의 일반 원칙과 장서관리지침으로 구분하고 각 항목별 내용 요소를 제안하였다. 그리고 국가 수준의 장서관리지침서가 학교 현장에 효율적으로 적용할 수 있는 제도적 기반 마련 방안을 제안하였다.