• Title/Summary/Keyword: Need for Approval

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A study on ethical requirements for the protection of human subjects in the publication guidelines of dental health journals (국내 치과 학술지 투고규정 중 연구대상자 보호를 위한 연구 윤리기준 제시에 관한 조사)

  • Jeong, Eun-Young
    • Journal of Korean society of Dental Hygiene
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    • v.14 no.2
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    • pp.241-250
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    • 2014
  • Objectives : The purpose of the study was to examine the ethical requirements for the protection of human subjects in the publication guidelines of dental health journals. Methods : The guidelines of 27 dental health journals were reviewed to determine ethical standards alone, with Helsinki Declaration, by an institutional review board (IRB), informed consent, protection of subject privacy and confidentiality, and no conflicts of interest. Results : 1. Dentistry journals listed on National Research Foundation of Korea had a conflict of interest disclosure provisions of the contribution(76.9%) and the IRB approval(61.5%). 2. Half of the dental health journals were not listed on National Research Foundation of Korea Society but they agreed the advance posting provisions. 3. Dental hygiene journals provide 100% of ethics alone and receive 75% of IRB in the papers. 4. Dental health and dental hygiene journals have conflicts of interest disclosure regulations(59.2%) and IRB approval(51.8%). 5. There existed statistically significant differences between the dental health journals whether they were listed on the human subjects and ethical standards for protection in National Research Foundation of Korea or not. Conclusions : While the publication guidelines of dental health journals have followed to a greater extent in recent years, there is still a need for further instructions to ensure that the authors satisfy all ethical requirements in conducting research on human subjects. IRB approval for dental journals must be standardized and reinforced reflecting the characteristics of each journals. The researchers should obey the code of ethics suitable for education and the editors must review the paper continuously.

A Case Study on the Process of Deteriorated Apartment Remodeling (노후 공동주택 리모델링 추진현황에 관한 사례 연구)

  • Song, Min-Jung;Kim, Soo-Jeong;Yoon, Chung-Sook
    • Proceeding of Spring/Autumn Annual Conference of KHA
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    • 2004.11a
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    • pp.375-380
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    • 2004
  • Restricting reconstruction, demand of remodeling has increased in deteriorated apartment. But remodeling process and steps are not taken, it is difficult to advance smoothly. Therefore, this study indicates improvement plans and understands the problems In advancing remodeling. In the result of the investigation the problems are the resident of agreements and legal approval. The goverment must complete laws about remodeling. Also, residents and an association need plans for conversation.

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Proposed Improvements for Type Approval and Inspection Systems of Marine Pollution Prevention Materials and Chemicals (해양오염방제 자재·약제 형식승인 및 검정 개선방안에 대한 연구)

  • Pankil Jang;YeongGu Song;Heejin Lee
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.29 no.1
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    • pp.15-23
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    • 2023
  • Through the revision of the Framework Act on Administrative Regulations (July 17, 2019), the government minimized regulations and applied the comprehensive negative regulation principle to enhance economic vitality. However, a legally mandatory certification system has been applied to marine pollution prevention materials and chemicals, and inspection is conducted every time a product is sold, suppressing the autonomy of manufacturers. In addition, the majority of manufacturers of marine pollution prevention materials and chemicals are small businesses; therefore, they take the approach of producing small quantities of products whenever a buyer requests an order. Consequently, the need for deregulation was raised to ensure autonomy of the market and industry, and improve efficiency in accordance with the current trend of approval, performance test, and inspection systems for marine pollution prevention materials and chemicals. In this study, problems within the current system were identified and improvement plans are proposed through comparison and analysis of domestic and foreign systems.

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.

Status and prospect of safety evaluation of genetically modified microorganism (GMM) for domestic and foreign food application (국내·외 식품용 유전자변형미생물 안전성 심사 현황 및 전망)

  • Kim, Seong-Bo;Kim, Yang Hee
    • Food Science and Industry
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    • v.52 no.2
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    • pp.153-170
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    • 2019
  • With the breathtaking stride beingmade in the field of biotechnology, biocatalyst research using genetically modified microorganism (GMM) is actively being pursued in food industry. However, domestic food and food additive regulation standards and the number of examination management examples currently used in industry is lacking significantly. Up till now, there are only 6 examples of domestic GMM examination and approval cases for food production purposes and furthermore they are limited to the production of functional sweeteners. Domestically, although GMM is developed as a processing aid (contained use), if they are used in the production of food, the safety of GMM, including environmental safety, is evaluated. Also the produced food or food additives using GMM need to be separately examined and approved as a novel food. On the other hand, imported products produced using GMM need to gain approval for the final product only. Thus the expense and the time to obtain regulatory approval is advantageous for imported products versus domestically produced products. This commentary is written to create the opportunity to reform the current domestic food GMM regulation by comparing and discussing domestic and foreign case analyses of safety evaluation of GMM and related regulations.

A Study on the Feasibility of the Timing for the Implementation of Energy-Saving Plan of Buildings Based on the Approval of Business Plan and Construction Permit (건축물에너지절약계획서의 사업계획승인, 건축허가에 따른 적용시점의 타당성 연구)

  • Kim, Dae-Won;Kim, Young-Il;Chung, Kwang-Seop
    • Journal of Energy Engineering
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    • v.21 no.3
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    • pp.265-270
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    • 2012
  • The delay in the construction permit for the building, which obtained the approval of business proposal, may lead to a difference in the maintenance cost ranging between 20% and 30% in the neighborhood where the residents moved in, along with the new project under construction in the surrounding area amidst rigorous regulations that aim to promote energy-saving and the heightened interest of the public in energy conservation, and such problem would become the major source of serious public complaints. Thus, the energy-saving plan needs to be prepared when the approval is granted to the business plan. In order to prevent public complaints or ensure effectiveness of government's energy plan, it may be effective to apply the energy-saving plan based on current standards upon the award of construction permit when two years have elapsed since the date of the scheduled commencement of construction or when the start of construction is delayed as stipulated in the Article 18 of the Enforcement Decree of Housing Act. If the energy-saving plan and related technologies are merely the parts of license and permit process without fully serving their purposes and functions, it would be waste of time to deploy a lot of workforce and review and seek consultation. The government or owners of buildings need to fully understand the energy-saving aspects and exert effort to enhance the energy efficiency of buildings.

A Study on the BTS Goods Values and Collaboration Brand Preference According to Fandom Type: Focusing on BTS Fan-club 'ARMY' (팬덤 동기에 따른 BTS 굿즈 가치와 협업 브랜드 선호도 연구: BTS 팬클럽 ARMY를 대상으로)

  • Lee, Minju;Yoo, Jiwon;Ko, Eunju
    • Journal of Fashion Business
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    • v.25 no.1
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    • pp.165-178
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    • 2021
  • With rise in economic activity of fandoms, fashion brands often collaborate with K-pop stars such as BTS to enhance brand preference and sales. This study analyzes why people engage in fandom activity and its effects on collaboration fashion brand preference by focusing on 'BTS' and fandom 'Army'. This study aims to provide information to establish marketing strategies by identifying the influence of fandom culture related to the Korean Wave and the fashion industry, and empirically analyzing factors affecting active customer formation for long-term growth. The data were collected from BTS fan club 'Army' and a total data sets were analyzed using SPSS25.0 statistics program. The findings of this research were as following. Frist, BTS fandom motivation were identified as Need for Approval, Communication Need, Professionalism Need, Need to Belong, Consumption Need and the BTS fan groups were categorized into 3 groups. Third, comparing BTS goods values and collaboration brand preference an excess in each group was revealed. This study is significant because it provides essential data for the marketing strategy of fandom market by comparing marketing effects of BTS with the characteristics of fandom consumers and identifying the different desires of each group. As a result of this research, it can be seen that BTS an influential leading brand, has been adopted, and the research direction of empirical analysis has been presented. In practice companies can select specific fandom targets by using the sub-levels of fandom types that have become clear and implement marketing strategies of the fandom market.

Antisense Oligonucleotide Therapeutics for Cystic Fibrosis: Recent Developments and Perspectives

  • Young Jin Kim;Adrian R. Krainer
    • Molecules and Cells
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    • v.46 no.1
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    • pp.10-20
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    • 2023
  • Antisense oligonucleotide (ASO) technology has become an attractive therapeutic modality for various diseases, including Mendelian disorders. ASOs can modulate the expression of a target gene by promoting mRNA degradation or changing pre-mRNA splicing, nonsense-mediated mRNA decay, or translation. Advances in medicinal chemistry and a deeper understanding of post-transcriptional mechanisms have led to the approval of several ASO drugs for diseases that had long lacked therapeutic options. For instance, an ASO drug called nusinersen became the first approved drug for spinal muscular atrophy, improving survival and the overall disease course. Mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene cause cystic fibrosis (CF). Although Trikafta and other CFTR-modulation therapies benefit most CF patients, there is a significant unmet therapeutic need for a subset of CF patients. In this review, we introduce ASO therapies and their mechanisms of action, describe the opportunities and challenges for ASO therapeutics for CF, and discuss the current state and prospects of ASO therapies for CF.

A Study on the Establishment of Management System for Continuing Airworthiness of Small Aircraft (소형항공기의 지속감항성 관리체계 구축을 위한 연구)

  • Yoo, Seung-Woo;Kim, In-Gul
    • Journal of the Korean Society for Aviation and Aeronautics
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    • v.23 no.2
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    • pp.57-62
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    • 2015
  • As the issuance of type certificate and production certificate for KC-100 Naraon, Korea is ranked as the State of Design and the State of Manufacture for civil aircraft specified in the Convention on International Civil Aviation. It means that another responsibilities are imposed and new frameworks are required for the airworthiness management including the continuing airworthiness. So far the minimum airworthiness management system was sufficient as the State of Registry for the aircraft operations and safety management. However, we need to establish and maintain the airworthiness management system for the effective certification and oversight of our air operators and approval holders. This paper introduces the new obligations under the Convention on International Civil Aviation, reviews the current aviation regulations and procedures and presents the strategy for the establishment of the regulatory system to ensure the airworthiness of aircraft.

A Comparative Study on the Regulations on Implantable Bioabsorbable Combination Products -Focusing on the U.S., Europe and Korea- (이식형 흡수성 융복합 의료제품 규제 비교 연구 -미국, 유럽, 한국을 중심으로-)

  • Hyeon Jeong Lee;Mi Hye Kim;Ju Eun Seol;Su Dong Kim;Joo Hee Kim
    • Journal of Biomedical Engineering Research
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    • v.44 no.6
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    • pp.414-427
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    • 2023
  • Implantable bioabsorbable combination products undergo inherent degradation and systemic absorption within the physiological environment, thereby streamlining the therapeutic regimen and obviating the imperative for invasive extraction procedures. This inherent property not only enhances patient convenience and therapeutic efficacy but also underpins a paradigm of support characterized by heightened safety parameters. Within the regulatory landscapes of Korea, the United States, and Europe, implantable bioabsorbable combination products are meticulously classified into distinct categories, either as pharmaceutical implants or as implantable medical devices, depending on their primary mode of action. This scholarly investigation systematically examines the regulatory frameworks governing implantable bioabsorbable combination products in South Korea, the United States, and Europe. Notable discrepancies across national jurisdictions emerge concerning regulatory specifics, including terminology, product classification, and product name associated with these products. The conspicuous absence of standardized approval regulations presents a formidable barrier to the commercialization of these advanced medical devices. This academic discourse passionately emphasizes the critical need for formulating and implementing a sophisticated regulatory framework capable of streamlining the product approval process, thereby paving the way for a seamless path to commercializing implantable bioabsorbable combination products.