• Title/Summary/Keyword: Approved

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

  • Park, Chang-Un;Cha, Cheol-Pyo
    • Journal of Fisheries and Marine Sciences Education
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    • v.25 no.1
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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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    • v.30 no.12
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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.

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

  • Lee, Chang-Sook;Kim, Jong-Chill
    • International Commerce and Information Review
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    • v.13 no.4
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    • pp.351-373
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    • 2011
  • Certificates of Origin(C/O) are necessary to gain benefits from preferential tariff treatment under the Free Trade Agreement(FTA). The C/O can be issued by issuing authorities or by exporters themselves. Recently, due to signed FTA such as Korean-EU FTA, issuance of self-declared C/O by exporters is increasing. In order to be qualified to issue self -declared C/O, exporters are required to acquire Approved Exporter status. An Approved Exporter is only required to present an invoice to substitute the certificate. The invoice contains an Approved Exporter number and a declaration that states the goods comply with the origin requirements. Either certification or notarization is not necessary. In result, the exporters are responsible for application of a preferential tariff under the self-declared C/O which issued incorrectly, even if it is not intentional. Therefore, in this paper, we studied authorization for Approved Exporter status and the practical use of its status. If companies obtain more Approved Exporter status, the effects of FTA would be maximized due to application of a preferential tariff under the C/O.

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

  • Woo, Hee-Jong;Chung, Chan-Mi;Shin, Kong-Sik;Ji, Hyeon-So;Lee, Ki-Jong;Suh, Seok-Chul;Kweon, Soon-Jong;Cho, Yong-Gu
    • Journal of Plant Biotechnology
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    • v.36 no.2
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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.

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

  • Moon, Gae-Ju;Rhee, Jinn-Ie
    • YAKHAK HOEJI
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    • v.56 no.1
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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.

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

  • Jun-Hyeok Hwang;Kyu-wang Kim
    • Journal of Advanced Navigation Technology
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    • v.28 no.1
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    • pp.51-59
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    • 2024
  • Currently, the approved training organization (ATO) is being used worldwide to supply excellent pilots in the aviation industry. This system, which is used worldwide, has been transformed and utilized according to each country. In this study, the operation method and educational environment of specialized pilot training institutions in Korea were examined in detail, and the differences were compared by comparing the operation methods and flight education environments of international standards, the United States, Europe, Canada, and neighboring countries such as Japan, China, and Singapore to derive differences from the system of specialized educational institutions in Korea. Based on these comparative data, through a survey of workers in the relevant work, satisfaction with the number of department classes set by the domestic aviation safety law specialized educational institution designation standards differed greatly depending on the characteristics of the survey subjects, and the importance differed depending on the department's class subjects.

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

  • Kim, Jin-Seok
    • Journal of Pharmaceutical Investigation
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    • v.30 no.2
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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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Recent Advances in Anti-Obesity Agents (비만 약물 치료의 최신 지견)

  • Kim, Min Kyung;Kim, Chul Sik
    • The Korean Journal of Medicine
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    • v.93 no.6
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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
    • Journal of the Ergonomics Society of Korea
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    • v.33 no.4
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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.

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

  • Jeong, Kyeong Hye;Lee, Euni
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.2
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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.