• Title/Summary/Keyword: Need for Approval

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Immunogenicity of Recombinant Human Erythropoietin: Clinical Cases, Causes and Assays

  • Heo, Tae-Hwe;Kim, Young-Kwon;Yang, Seung-Ju;Cho, Hyun-Jeong;Kim, Sung-Jo
    • Biomedical Science Letters
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    • v.15 no.2
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    • pp.161-166
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    • 2009
  • Human erythropoietin(EPO) is a glycoprotein that enhances red blood cell production by stimulating proliferation and differentiation of erythroid progenitor cells in the bone marrow. Patients with chronic kidney disease(CKD) suffer from anemia caused by reduced production of EPO in the kidney. Recombinant human EPO protein has been used successfully for the treatment of anemia associated with CKD. Recently, attention has been paid to the development of side effect of EPO, pure red cell aplasia(PRCA), in some patients with CKD. PRCA is a rare disorder of erythropoiesis that leads to a severe anemia due to an almost complete cessation of red blood cell production. EPO-related PRCA is caused by the production of EPO-neutralizing antibodies(Abs) that eliminate the biological activity of EPO as well as endogenous EPO in patients undergoing therapy. Since 1988, almost 200 cases worldwide have been reported with Ab-positive PRCA after receiving EPO therapeutics. The underlying mechanisms of the breaking of immune tolerance to self-EPO have been investigated. Modification of formulation, organic compounds of container closures, and route of administration has been suggested for the possible mechanism of increased immunogenicity of EPO. A number of assays have been used to detect Abs specific to EPO. These assays are generally grouped into two major categories: binding Ab assays and neutralizing Ab assays(bioassays). There are several types of binding Ab assays, including radioimmunoprecipitation assay, enzyme-linked immunosorbent assay, and the BIAcore biosensor assay. In vitro cell-based bioassays have been utilized for the detection of neutralizing Abs. Finally, the recent experience with anti-EPO Abs may have considerable implications for the future development and approval of EPO preparations. Also, considering that millions of patients are being treated with EPO, clinicians need to be aware of signs and consequences of this rare but severe clinical case.

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Improving the Standards of Midwifery Education and Practice and Extending the Role of a Midwife in Korean Women and Children′s Health Care

  • Lee, Kyung-Hye
    • Journal of Korean Academy of Nursing
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    • v.33 no.8
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    • pp.1111-1118
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    • 2003
  • Background. A midwife is a medical professional who has a nursing license, and is also licensed as a midwife with one additional year of education. In this globalization era, a midwife's role is increasing in importance for women and children's health care worldwide. Purpose. The primary purpose was to analyze midwifery education programs in Korea and other nations. The secondary purpose was to define strategies to improve midwifery education and practice, and to extend the role of a midwife women and children's health care in Korea. Methods & Results. 1) The definition of a midwife and midwifery practice recognized internationally by World Health Organization (WHO) and International Council of Nurse Midwives (ICNM) was identified. 2) Midwifery education programs of Korea, U.S.A., Sweden, Australia, and Japan, were investigated and discussed. 3) Core competencies for the basic midwifery practice suggested by ACNM of the U.S.A. were reviewed as standard of midwifery practice. 4) As for the midwifery education system, a Masters degree program in a college of nursing is suggested. 5) The role of a midwife includes not only health care of childbirth women and newborn babies, but also a lifelong health care of women as well as her family and children. Conclusion. An effort to extend the midwife's role and to improve service is imperative. The Laws/Acts related to midwives should be revised in regard to education, and practices, and the national examination for midwifery licensure needs revision to qualify for international approval. Also, midwifery curriculum and standards of practice need to be evaluated periodically, and an effective system needs to be established to renew midwife licenses.

A Study on the Judgement Rating for Level of Need for Long-term Care Insurance Using a Decision Tree (노인 장기요양보험의 등급판정을 위한 의사결정나무 연구)

  • Han, Sang-Tae;Kang, Hyun-Cheol;Choi, Bo-Seung;Lee, Seong-Keon
    • Communications for Statistical Applications and Methods
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    • v.18 no.1
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    • pp.137-146
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    • 2011
  • Long-term care insurance is a social insurance system that provides benefits to the elderly who have difficulty taking care of themselves for a period of at least 6 months. This system was started in July, 2008 and it is very important to set proper judgement ratings for the approval process. We try to develop and improve the judgement rating system using decision tree models. Our tree model is found to be more stable and efficient than the previous one.

The National Environmental Education Act of the U.S.: Its Effects, Issues and Implications (미국 국가환경교육법의 효과, 쟁점 및 시사점)

  • Lee, Sun-Kyung;Lee, Jae-Young;Shin, Ho-Sang;Cho, Kil-Young;Choi, Suk-Jin
    • Hwankyungkyoyuk
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    • v.16 no.1
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    • pp.61-74
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    • 2003
  • It is essential to develop legal and legislative devices like the National Environmental Act to conduct systematic and continuous environmental education. In many Countries including the Uinted States, Great Britain, Germany, and Australia, environmental education has been developing based on legal and legislative systems. Of those cases, the Uintes States made efforts to promote environmental education through legislation, which can have significant implications for us with intention to legislate the National Environmental Education Promotion Act. This study is focusing on our environmental education by studying the histiry and current situation of National Environmental Education Act, PL 91 516 of the United States and its features. In case of the United States, there has been several amendments and re-approvals. since the first National Environmental Education Act was legislated. The public hearing for the re-approval of National Environmental Education Act whIch was legislated in 1990 was held during the Summer of 2000. This gave us important reference data including the need of environmental education, its effects, and considering articles. As a result of the public hearing, 1990. National Environmental Education Act was recognized and some articles were amended. Its re-approved as John H Chafee Environmental Education Act of 2001, PL 107-S 876 IS Some implications and suggestions were drawn from the case study, which included the importance of related ministries, financial support, the role of Consulting Committee and Special Committee for environmental educators, environmental education program certification system.

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Consideration on the Ballast Water Treatment System Technology and its Development Strategies (IMO 선박평형수 처리장치 기술과 발전 방향에 대한 고찰)

  • Kim, Eun-Chan
    • Journal of the Korean Society for Marine Environment & Energy
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    • v.15 no.4
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    • pp.349-356
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    • 2012
  • For smooth implementation of the IMO Ballast Water Management Convention that is to come into effect in the near future, IMO and Member States are working on the development of various technologies and establishment of legislative action. Ballast water treatment systems are essential, yet difficult technologies, as they need not only to treat living organisms, but also define whether they are viable or not, count the number of viable organisms, and present quantitative results of the concentration of active substances. Despite the fact that the Convention is looming in the near future, the issues mentioned above obstruct the setup of consensual technologies for performance reliability of the treatment system and analysis method of efficacy test results. This paper considers the unsolved issues of the ballast water treatment technologies, and presents guidelines to solve these issues.

A Statistical Analysis of the General Anesthesia for Dental Treatment to Children with Developmental Disability (장애 환자의 소아치과 치료 시 전신마취에 대한 통계적 고찰)

  • Choi, Young-Kyoo;Lee, Sung-Min;Kim, Dong-Ok
    • Journal of The Korean Dental Society of Anesthesiology
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    • v.2 no.2 s.3
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    • pp.101-106
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    • 2002
  • Background: The management of the behavior of handicapped children when providing required dental care is often a problem, whether in the dental office or in a hospital setting. Because of the high incidence of poor cooperation, many of these patients are scheduled for dental care under general anesthesia with preoperative medical assessment. The purpose of this study was to carry out a clinico-statistical survey on dental treatment for handicapped children under general anesthesia. Methods: After approval from the institutional review board, the medical records of 64 handicapped children between 1997 and 2002 were reviewed to determine the patient profiles, anesthesia management, and complications. The charts of these patients, who underwent dental examination, scaling and prophylaxis, and restoration and extraction of teeth under general anesthesia, were reviewed. Results: The mean age was 12.8 years old, and males (53%) predominated females (47%). Twenty-four patients had mental retardation, twelve had autism, six had cerebral palsy, 4 had behavior disorder, others had heart disease, convulsive disorder, etc. Sixty-two had intravenous thiopental with neuromuscular blocker, 2 had intravenous ketamine induction. Nasotracheal intubation was uneventful in 55 patients, nine had orotracheal intubation because of difficult visualization of the larynx. Twenty-one patients experienced postoperative complications in the recovery room, including epistaxis, nasal obstruction, vomiting, airway obstruction, respiratory depression. Conclusions: General anesthesia is a very effective way of completing the dental treatments for disabled children. We emphasize the need to train anesthesiologists in the care of disabled patients.

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A Study on Data Research for Fire Regulations and Fire Retardant in Interior Architecture (실내건축관련 소방(消防)규정과 방염(防炎)에 관한 연구)

  • Cho, Sung-O;Kim, Yong-Sung
    • Korean Institute of Interior Design Journal
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    • v.19 no.3
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    • pp.95-102
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    • 2010
  • Recently, a grow in size and features of Interior construction work over the complex and The Fire-related regulations have been strengthened for the prevention of fire damage. This study is purpose to propose interior design, construction and supervision for the efficient and reasonable way throughout the fire-related laws are investigated in interior architecture. First, the interior of the building work will be based on actual use Fire-related Laws and Regulations have be investigated. Second, based on analysis of material and facilities by Application can be used in production by the data were applied to the present. Third, the international Fire and Flame Retardant Standards for investigating and reviewing the relevant laws, differences and characteristics of each country were analyzed. Fourth, the various fire-related issues of regulation and the application of relevant provisions in the field works, the law's standards, and improvements were identified by analysis. Fire-Related Laws and Building codes that Safety Administration of the Fire Services are divided into design, it comes to approval from the municipal authorities with concerns about the fire that will fit on the Fire Department's administrative procedures and operations is necessary to integrate operations. In conclusion, Fire-related business are divided into Minister of Land, Transport and Maritime Affairs and Ministry of Public Administration and Security. So, Both institutions is need to be the cooperative work. It is necessary to the field supervision. Because, Flame-resistant performance standards in the field works applied are too complex. Last, Establishment of fire-related regulations will enact by private organizations and the experts to participate.

A Study on Competition Limitation Clause of International License Contract (국제라이선스계약상 경쟁제한조항에 관한 연구)

  • Oh, Won Suk;Jeong, Hee Jin;Kim, Jong Kwon
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • v.64
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    • pp.39-64
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    • 2014
  • The object of International License Contract is technology. Technology is means to produce visible goods, which are human's intellectual creations such as Intellectual Property Right - patent, design, trademark- and Know-how. Unlike visible goods which decrease as being used, these technologies are possible to be produced expansively and develop additionally. Therefore, the way to make a contract of goods is a sales contract which transfers ownership while technology follows license contract which gives approval of use for a certain period. International license contract means that licensor has right to possess, allows licensee to use licensed technology for a fixed period and takes royalty. So there are various matters such as selection of the duration of a contract, confirmation of technology range, competition limitation, technique guidance and support, calculation of royalty, withholding tax between parties. This study examines licensor's grant of license and competition limitation. Intellectual property rights fundamentally give exclusive rights to the creator so the licensor use or dispose of his or her intellectual property rights at will. Technology transfer is possible through license contract because of this right. But licensor must exercise his or her intellectual property rights within a reasonable limit. It means, when licensor makes an unreasonable demand abusing his or her position, it is regarded as competition limitation clause and the deal itself may become null. Therefore, restraint on competition needs to be examined in detail as it influences on contract validity. Each country has their own competition laws for establishing a fair market order and inspection guide and guideline for judging whether there is any unfair act related to intellectual property rights. Judgment on intellectual property rights is subject the technology-introduced country's domestic laws and thus, contracting parties each need to precede opposite nation's domestic laws system.

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Critical Reviews of Academic Research and Perspectives for Understanding the Humidifier Disinfectant Disaster (가습기살균제 참사에 관한 학술연구의 비판적 검토와 다양한 관점의 이해)

  • Kim, Jiwon;Bahng, Yewon;Park, Moon Young;Zoh, Kyung Ehi;Choi, Yeyong
    • Journal of Environmental Health Sciences
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    • v.45 no.4
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    • pp.340-357
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    • 2019
  • The purpose of this paper is to help develop a comprehensive understanding of the humidifier disinfectant disaster from diverse perspectives based on a critical review of the relevant academic research papers published so far in the fields of both natural and social science. The authors reviewed pertinent articles in the six academic areas of law, social science, humanities, medicine, toxicology, and environmental health. A proper understanding of the issue of humidifier disinfectant is a challenging task because diverse aspects of it have become related over the more than two decades since such products were first released to the market in 1994. Technical and esoteric issues such as the complex system for relief and compensation for health damages and the approval of chemical toxicity are known to be major impediments to viewing the bigger picture regarding this tragedy. The authors believe that experts need to consider a comprehensive perspective going beyond their individual research arena to gain a better understanding of this issue, especially since it was an alarm signal on ethics and the role of experts and scholars in Korean society. Besides the two professors arrested by the prosecutor's office, it should be remembered that medical doctors recommended patients use humidifiers and disinfectants, and the media was inactive in reporting on this issue. Furthermore, the current paucity of examination of the social and political implications of this tragedy calls for more active engagement by researchers in the humanities and social sciences. In this regard, this paper is a work of self-examination and self-criticism by the authors that could resonate with the overall academic community.

An Empirical Analysis of Economies of Scope in the Small Crop-Livestock Cycling Organic Farming -Case of 'W-farm' in Pyungchang - (소규모 경축순환 유기농가 경영에서의 범위의 경제성 실증 분석 -평창군 'W농장' 사례를 중심으로-)

  • Choi, Deog-Cheon
    • Korean Journal of Organic Agriculture
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    • v.24 no.4
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    • pp.665-680
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    • 2016
  • Theoretically, it is said that economies of scope can be realized in the cropelivestock cycling organic farming. Thus, it is also used as the principle of organic farming. However, it is difficult to find the cases of the empirical analysis of it in Korea. In that sense, this study is meaningful in that it analyzed the agricultural data of case farms of obtaining the approval of both organic agricultural products and organic animal products and practicing cycling farming for 4 years and tested the hypothesis. This study measured economies of scope by using the actual measurement value and estimation value farming performance statistics for 4 years of case farms. This farmhouse conducted nutrient cycling in the farm like self-manufacturing and injecting organic agricultural byproduct and wild grass as organic livestock feed and fermenting organic livestock manure to organic compost to return it 100%. The results can be summarized as follows: According to the result of cycling farming of combining and producing organic agriculture and organic livestock, economies of scope were found to be realized in this case farmhouse. That is, although not strong, EOS>0, there were economies of scope. The measurement value appeared as 0.0722, 0.00378, 0.04667 and 0.13127 in 2012, 2013, 2014 and 2015, respectively. It was improved as time passes and the scale gets smaller. Therefore, in order to further improve economies of scope, there should be measures of reducing duplication costs between agriculture-livestock as low as possible and lowering the production cost of organic feed. That is, there is a need for the management strategy to adjust the import function and cost function according to the change in management paradigm and cropping system.