• 제목/요약/키워드: Approved

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수·해양 전문계고 인정도서 제도의 법적 문제와 과제 (An Attempt to the Legal Problems on the Approved Books in Fisheries and Marine Sciences Education)

  • 박창언;차철표
    • 수산해양교육연구
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    • 제25권1호
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    • pp.65-77
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    • 2013
  • This study is to suggest the legal issues and some question to solve on the approved books in fisheries and marine sciences education. The results of the study are following. First, It discuss the legal meaning on the approved books. The meaning of the approved books means the curriculum books are subject to an approval by the Minister of Education, Science and Technology in order to use term in case where there exist no government-designated books and authorized, or where it is difficult to use term or it is necessary to supplement them. Second It deals with the legal issues on the approved books in fisheries and marine science education. The main issue is in harmony with the regimentation and self-regulation of education. This matter is the legal problems on the power for the standards of the textbooks approval and the rights for the organization of the textbooks. Third, It treats the problems of the approved books in fisheries and marine sciences education. The problems is system of statute and concept of approved books, the rights of nation and local government, standards of approved books, and writing and practical use of approved books. I generalize legal issues on the approved books in fisheries and marine sciences education. Hence, it is necessary to deeply study each subject in the legal aspect of the approved books in fisheries and marine sciences education.

Repurposing Screens of FDA-Approved Drugs Identify 29 Inhibitors of SARS-CoV-2

  • Ku, Keun Bon;Shin, Hye Jin;Kim, Hae Soo;Kim, Bum-Tae;Kim, Seong-Jun;Kim, Chonsaeng
    • Journal of Microbiology and Biotechnology
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    • 제30권12호
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    • pp.1843-1853
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    • 2020
  • COVID-19, caused by the novel coronavirus SARS-CoV-2, has spread globally and caused serious social and economic problems. The WHO has declared this outbreak a pandemic. Currently, there are no approved vaccines or antiviral drugs that prevent SARS-CoV-2 infection. Drugs already approved for clinical use would be ideal candidates for rapid development as COVID-19 treatments. In this work, we screened 1,473 FDA-approved drugs to identify inhibitors of SARS-CoV-2 infection using cell-based assays. The antiviral activity of each compound was measured based on the immunofluorescent staining of infected cells using anti-dsRNA antibody. Twenty-nine drugs among those tested showed antiviral activity against SARS-CoV-2. We report this new list of inhibitors to quickly provide basic information for consideration in developing potential therapies.

한국의 인증수출자 제도에 관한 법적 고찰 (Approved Exporter Status in Korea)

  • 이창숙;김종칠
    • 통상정보연구
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    • 제13권4호
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    • pp.351-373
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    • 2011
  • FTA가 동시다발적으로 체결됨에 따라 특혜 관세의 적용을 위하여 원산지증명서가 중요하게 되었다. 이러한 원산지증명서의 효율적 발급을 위해 원산지 인증수출자 제도가 정착될 필요가 있다. 또한 동 제도가 시행되어 이미 정착되었어야 함에도 불구하고 한-EU FTA 발효 이후에 이슈화되고 있는 점을 감안할 때 시기적으로도 매우 늦은 감이 있다. 따라서 본 연구에서는 원산지 인증수출자 제도를 고찰하고, 동 제도의 조기 정착을 위한 실용화 방안을 제시하여, FTA의 효과를 극대화시키는데 그 목적이 있다. 원산지 인증수출자 지정 및 운영과 관련하여 실용화 방안을 제시하면 다음과 같다. 먼저, 원산지 인증수출자 제도에 대한 실질적 홍보를 강화하여 인증수출자 지정 업체수를 늘려야 할 것이다. 둘째, 산업별 맞춤 원산지관리시스템 구축을 지원하여 원산지 인증수출자의 기본적인 인증요건을 손쉽게 갖출 수 있도록 하여야 한다. 셋째, 원산지관리전담자 양성 기회를 확대하여 해당 인력을 원산지관리전문가로 양성하여야 한다. 넷째, FTA-PASS 서비스 장애 제거를 위한 조기경보시스템을 도입하여 안정적인 시스템을 제공하여야 한다. 다섯째 사후관리 철저 및 위반에 대한 법규를 강화하여 원산지 인증수출자 제도가 안정적으로 정착되도록 하여야 한다.

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국내외 상업화 GM 작물의 유전요소 분석 (A survey of the genetic components introduced into approved GM crops)

  • 우희종;정찬미;신공식;지현소;이기종;서석철;권순종;조용구
    • Journal of Plant Biotechnology
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    • 제36권2호
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    • pp.106-114
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    • 2009
  • Genetic components introduced into approved GM crops are a key subject for safety assessment and provide a basis for the development of detection methods for GM crops. In order to understand the genetic components in approved GM crops comprehensively, we screened the genetic vector maps of GM crops that had been approved for commercialization around the world. A total of 64 varieties from 5 major GM crop species (maize, canola, cotton, soybean, and tomato) were subjected to analysis. The genetic components included genes, promoters, terminators, and selection marker. This survey may be useful for researchers who develop GM crops and methods for detecting GM crops.

우리나라 제약기업의 의약품 허가 및 특허출원 관련요인 분석 (Factors Associated with Drug Approvals and Patent Issues of the Korean Pharmaceutical Firms)

  • 문계주;이진이
    • 약학회지
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    • 제56권1호
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    • pp.60-65
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    • 2012
  • This study examines factors associated with drug approvals and patent issues of the Korean pharmaceutical firms. The 22 firms were selected based on 2006 year's publicly noticed sales amount. Number of approved drugs was identified through Korea Food and Drug Administration and the information regarding the patents that each firm has issued during the year 2000~2006 was collected from the Korea Patent Office. The number of approved drugs has increased annually, especially after the introduction of substance patent system in 1987 and in 2000 again with the policy change into the separation of drug prescribing and dispensing practice. The number of initial approval of NCEs as well as the number of patents per firm decreased during the year 2000~2006. The 12 firms with larger revenue occupied more than 80% of the patents being issued. There was a positive relationship between share of prescription drugs out of approved drugs and the average number of patents issued. However, number of approved drugs did not show positive association with the number of patents issued per firm. Therefore, the study results imply that firms need to invest more in increasing number of approvals for their specific prescription drugs in order to achieve a good performance in the future.

비행교육을 위한 지정전문교육기관 비교분석 및 개선방안에 관한 연구 (A study on the Comparative Analysis and Improvement Direction of Approved Training Organization for Pilot)

  • 황준혁;김규왕
    • 한국항행학회논문지
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    • 제28권1호
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    • pp.51-59
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    • 2024
  • 현재 항공 산업 분야에 우수한 조종사를 공급하기 위해 전 세계적으로 전문교육기관 제도 (ATO; approved training organization)를 활용하고 있다. 세계적으로 활용되는 이 제도는 각 국가에 맞는 실정으로 변형되어 활용되고 있다. 본 연구에서는 우리나라 조종사 양성 전문교육기관의 운영방식 및 교육 환경을 자세히 살펴보고, 국제민간항공기구의 국제표준, 미국, 유럽, 캐나다 등과 일본, 중국, 싱가포르 등 주변국의 비행 교육기관 운영방식 및 비행교육 환경을 비교하여 차이점을 도출함으로써 우리나라 전문교육기관 제도와 어떠한 차이를 보이는지를 비교하였다. 이러한 비교자료를 기반으로 해당 업무 종사자들의 설문 조사를 통해 국내 항공안전법 전문교육기관 지정기준에서 설정하고 있는 학과 수업 양에 대한 만족도가 설문대상의 특성에 따라 큰 차이가 있었고 학과 수업과목에 따라 중요도의 차이가 발생하였다.

국내 유전자치료 의약품 개발 및 평가 시 고려해야 할 사항 (Points To Consider in Development and Evaluation of the Gene Therapy Products in Korea)

  • 김진석
    • Journal of Pharmaceutical Investigation
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    • 제30권2호
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    • pp.139-143
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    • 2000
  • Gene therapy is becoming a very promising and feasible medical intervention as the understanding of human diseases extends to their molecular levels. Since the first US Food and Drug Administration (FDA)-approved human gene therapy protocol was approved in 1990, over 300 human clinical trial protocols had been approved worldwide so far. Even though some of the domestic gene therapy clinical trials also proved promising and more are awaiting, it should be emphasized that many safety aspects as well as effectiveness aspects should be considered during the development process. Moreover, there seems to be less restricted guidelines from the National Control Authority (NCA) in initiating human clinical trials. This article is intended to suggest some basis and points to consider in the development and evaluation of gene therapy products including antisense oligonucleotides pharmaceuticals.

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비만 약물 치료의 최신 지견 (Recent Advances in Anti-Obesity Agents)

  • 김민경;김철식
    • The Korean Journal of Medicine
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    • 제93권6호
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    • pp.501-508
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    • 2018
  • Obesity is a chronic disorder that is a significant risk factor for diabetes, cardiovascular diseases, malignancy, and other chronic diseases. Lifestyle modifications form the basis of most treatments for obesity, but it has become clear that such modifications alone are not enough for many obese patients. When a behavioral approach is insufficient, pharmacological treatment may be recommended. In recent years, the US Food and Drug Administration (FDA) has withdrawn several therapeutic options for obesity due to their side effects, but has approved four novel anti-obesity agents. Until recently, orlistat was the only drug approved for the management of long-term obesity, but the US FDA approved the novel anti-obesity drugs lorcaserin and phentermine/topiramate in 2012, and naltrexone/bupropion and liraglutide in 2014. The present review discusses the different pharmacotherapeutic options for the treatment of obesity.

Suggestion of Risk Assessment Models for Cardiovascular Disease in the Workplace

  • Choi, Eui Rak;Jeong, Byung Yong
    • 대한인간공학회지
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    • 제33권4호
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    • pp.289-297
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    • 2014
  • Objective: The purpose of this study is to identify the incidence risk of cardiovascular disease (CVD) in the workplace, and to suggest the prediction models for level of CVD incidence risk. Background: CVD can be caused by various factors related to personal habits such as diet and exercise, or genetics. However it can also be caused and aggravated by work, making the elimination of such risk factors at work crucial disease (KOSHA, 2013). Method: The distribution of CVD risk assessment levels of 162 workers was compared with the acquired medical examination data to discuss the necessity of assigning additional risk factors. Two alternative risk assessment models were given to enhance the accuracy of the evaluation; adjusting risk scores given in the KOSHA GUIDE H-1-2013 (alternative 1) and building a matrix of KOSHA GUIDE H-1-2013 and risk assessment results based on work condition levels (alternative 2). To verify the suggested models, medical examination results of 12 workers approved of convalescence were referred to. Results: The second alternative showed more relevance between the results and workers approved of convalescence in predicting the risk group when applied to actual heath examination data from the approved workers. The power of description of the new method for determining the risk of CVD incidence, 83.3%, is higher than that of KOSHA GUIDE H-1-2013, 25%. Conclusion: Results of this study imply that more approved workers had been from unmanaged normal groups than managed risk groups, raising the importance of CVD management. Application: The new prediction model considering working time and shift work developed in this study is expected to be a fundamental data for risk analysis and management of CVD in the workplace.

Molsidomine, Nicorandil, Trimetazidine의 안전성 관련 체계적 고찰 (A Systematic Review on Drug Safety for Molsidomine, Nicorandil and Trimetazidine)

  • 정경혜;김은경
    • 한국임상약학회지
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    • 제26권2호
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    • pp.172-180
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    • 2016
  • Background: Ischemic heart disease is the most common type of heart disease and an important cause of death in Korea. Among marketed anti-anginal medications, molsidomine, nicorandil, and trimetazidine are approved in Korea with unique mechanism of actions. As these drugs are not approved by the US Food and Drug Administration, the access to the up-to-dated and comprehensive safety-related information has been less than optimal from drug information resources used by Korean pharmacists. Methods: A systematic review was conducted using Embase and Korean manuscripts to compile safety updates for these medications. Out of 418 articles from keyword searches, 52 studies were reviewed in full to compare adverse effects (AEs) with the approved package inserts (PI). Results: Molsidomine related adverse effects were mostly mild or moderate, but anxiety, palpitation, epigastric pain, and sexual potency reduction were additional AEs found from the review not listed in PI. Although PI has included ulceration in oral cavity and gastrointestinal tracts including anus by nicorandil, the Korea FDA recently recommended adding corneal, genital, and skin ulcers to the approved PI. Trimetazidine induced Parkinsonism, worsening of the symptoms for patients diagnosed with Parkinson's disease, gastrointestinal burning, and muscle cramps were additionally identified AEs not listed in PI for trimetazidine. Conclusion: Continuous evaluations of the safety profile of these agents are needed to balance the risks and benefits to provide evidence-based safety counseling to the patients. In addition, more focused efforts on spontaneous reporting are warranted by healthcare professionals to safeguard patients against AEs.