• Title/Summary/Keyword: Need for Approval

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Updates to Clinical Information on Anticancer Immunotherapy (항암 면역 치료제에 관한 최근 임상 정보)

  • Choi, Eunjoo;Yang, Jae Wook
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.1
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    • pp.65-75
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    • 2018
  • Objective: Over the last several years, immunotherapy has become one of the most promising therapeutic options for cancer. This study aims to summarize the updates on cancer immunotherapy focusing on immune checkpoint inhibitors, such as programmed cell death-1 (PD-1), programmed death-ligand 1 (PD-L1), and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors, which have received attention as new anticancer therapeutic agents. Methods: A literature survey was carried out on PubMed to identify high-impact papers on cancer immunotherapy from 2010. The most recent data on clinical efficacy and safety have been included highlighting the response characteristics to recently approved immunotherapeutic agents. Results: In various cancers, immune checkpoints are a means for cancer cells to evade the immune system. Furthermore, CTLA-4 and PD-L1 can be overexpressed, allowing malignant cells to evade T-cells. Numerous clinical trials have been performed to seek appropriate indication of these products in various cancer types. Among them, the most conspicuous types are melanoma, non-small-cell lung cancer, and head and neck cancer. The approval of ipilimumab by Food and Drug Administration (FDA) commenced a new era of cancer immunotherapy. This was followed by the approval of nivolumab and pembrolizumab. Currently, combination therapies are being investigated for various cancer types. Conclusion: In this study, we reviewed recently reported scientific and clinical evidence for currently approved immune checkpoint inhibitors. Although these novel checkpoint inhibitors are ever evolving for cancer therapies, there exist limitations that need to be overcome, indicating the necessity for further studies aiming to improve their efficacy, toxicity, and cost.

Optimal Control Scheme for Two-Stage Direct Power Converter (2단계 직접형 전력변환시스템의 최적제어기법 고찰)

  • Cho, Choon-Ho;Mo, Dong-Yeong;Lee, Sang-Chul;Choi, Chang-Young;Lee, Gun-Sik;Kim, Tae-Woong;Park, Gwi-Geun
    • Proceedings of the KIPE Conference
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    • 2010.07a
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    • pp.158-159
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    • 2010
  • Two-Stage Direct Power Converter(TSDPC) has many merits that possible bidirectional power flow, input power factor own control and system using imaginary DC-link. But TSDPC has some demerits that need many switching devices and switching loss. This paper suggest optimal TSDPC control scheme for improvement for switching loss part by changing the space vector approval times. This paper is verified that 9% improvement in switching efficiency and proposed system has lower harmonic of input currents and output voltage.

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Security Method for Approval Process of Payment System (지불시스템의 승인단계에서 보안방안)

  • 임인채;위장현
    • Journal of Korea Society of Industrial Information Systems
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    • v.7 no.4
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    • pp.59-65
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    • 2002
  • Payment systems in EC need confidentiality, integrity, non-repudiation. All transactions between cardholders and merchants must be authorized by a payment gateway in SET protocol. RSA secret key operation which requires heavy computation takes the most part of the time for payment authorization. For the reason, a heavy traffic of payment authorization requests from merchants causes the payment gateway to execute excessive RSA secret key operations, which may cause the bottleneck of the whole system. To resolve this problem, One-Time Password technique is applied to payment authorization step of the SET protocol.

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A Study on Development of Guideline on Writing Technical Document for Electrical Medical Devices : Bone Absorptiometric X-ray System (엑스선골밀도측정기의 기술문서 작성을 위한 가이드라인 개발 연구)

  • Lee, Seung-Youl;Kim, Jae-Ryang;Kim, Eun-Rim;Lee, Jun-ho;Lee, Chang-Hyung;Park, Chang Won
    • Journal of radiological science and technology
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    • v.39 no.2
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    • pp.263-271
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    • 2016
  • The market size of the bone absorptiometric X-ray system and the number of its approval by Ministry of Food and Drug Safety (MFDS) has annually increased, with a trend of increasing aging population and osteoporosis patients. For approval of manufactured or imported medical devices in Republic of Korea, it is required to submit its technical document. Therefore, it is need to develop the technical document guideline for the bone absorptiometric X-ray system for manufacturers, importers and reviewers. First of all, the technical documents which were already approved were examined and analyzed through MFDS approval administration system. Second, safety and performance test standards and methods that match international standards were drawn after conducting survey of the market status and the technology development trend for it, with examination and analysis of applicable domestic and overseas standards. Third, by operating industry-research-government cooperation, the guideline draft on writing technical document for the bone absorptiometric X-ray system was discussed, collecting their opinion. As a result, it is suitable to international and domestic condition, includes test evaluation methods and offer various information with appropriate examples to civil petitioner, when they write the technical documents.

The e-Commerce Regulation and System Structure in China (중국 전자상거래 제도구축에 관한 연구)

  • Lee, Byeong-Ryul;Kim, Jong-Chill
    • International Commerce and Information Review
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    • v.7 no.3
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    • pp.231-246
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    • 2005
  • Concerning the regulation of Internet service and the control of electronic commerce in China, It has not specific regulation and various rules or measures to enforce it yet. The common regulatory measures are that online business in some special areas must acquire a license or approval from relative agencies in advance. But whether licensing is an effect regulatory measure still takes time to verify. Accordingly these measures must be unified or coordinated to be enforced effectively. In order to encourage the development of E-Commerce, China will need to focus on developing rules that take advantage of the internet to encourage the economy, and establishing new legal rules or amending the traditional law to create a safe and secure legal environment for online transactions.

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International regulatory considerations pertaining to the development of stem cell-based veterinary medicinal products

  • Jeon, Byung-Suk;Yi, Hee;Ku, Hyun-Ok
    • Journal of Veterinary Science
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    • v.22 no.1
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    • pp.6.1-6.6
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    • 2021
  • Stem cell-based products (SCPs) are an emerging field of veterinary medicine that focuses on the regeneration, repair, or replacement of damaged tissues or organs. However, there are some issues in applying the traditional regulatory guideline for the approval of SCPs as veterinary medicinal products. This article describes the positions of Korea, US, and EU regarding SCPs, and compares the regulatory guidelines of each country for their safety evaluation. Although there are some differences in the regulatory guidelines, similar considerations in identifying the quality of SCPs and their safety has adopted. Overall, these guidelines need to be harmonized among countries.

Survey on Pharmacist's Awareness of E-commerce for Non-prescription Medicine (일반의약품의 전자상거래에 대한 약사의 인식도 고찰)

  • Park, Young-Dal;Bang, Joon Seok;Min, Young Sil;Sohn, Uy Dong
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.2
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    • pp.137-149
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    • 2016
  • Objective: Online pharmacies were introduced in some countries such as United States of America or Canada. They can provide benefits to consumer because they can buy and take conveniently drugs without limitation of location or time. In Korea, online pharmacies are illegal and only pharmacists can sell drugs to consumers or patients. Therefore, we investigated the knowledge of online pharmacy and the possible problem in Korea to survey pharmacists. Methods: We developed questionnaire based on previous articles about online pharmacy and surveyed nation-wide pharmacists by mail or e-mail. The data was analyzed by SPSS and Microsoft Excel. P-values less than 0.05 were statistically significant. Results: 175 pharmacists involved in this study. About introduction of online pharmacies, 53.1% were opposition while 10.3% were approval and 36.6% were conditional. Although online pharmacies were introduced, 46.3% pharmacists do not have a plan to start online pharmacy. However, the approval and tends about starting online pharmacies were higher in younger pharmacists (20s, 30s) (p < 0.05). The criteria of permission about opening online pharmacies were 100% pharmacist license regardless of holding off-line pharmacy. 53.7% pharmacists responded education about taking medication is impossible. When online pharmacies are introduced, 65.1% pharmacists responded traditional pharmacies are affected negatively. Pharmacists concerned that the competition with large-sized distribution corporations, reduced reliance between pharmacists and patients, illegal transaction of counterfeit drugs, increased misuse of drugs. Conclusion: These results showed that Korea pharmacists have negative standard on online pharmacies. Therefore it is required to be more cautious before introducing online pharmacy and it need strict watching system and continuous education and study for safety after introducing online pharmacy.

60 Years since the Armistice Treaty, the NLL and the North-Western Islands (정전협정 60년, NLL과 서북 도서)

  • Jhe, Seong-Ho
    • Strategy21
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    • s.31
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    • pp.27-56
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    • 2013
  • The United Nations Command (UNC) and the communist North failed to reach an agreement on where the maritime demarcation line should be drawn in the process of signing a truce after the Korean War because of the starkly different positions on the boundary of their territorial waters. As a result, the Armistice Treaty was signed on July 1953 without clarification about the maritime border. In the following month, Commander of the UNC unilaterally declared the Northern Limit Line (NLL) as a complementing measure to the Armistice. Referring to this, North Korea and its followers in South Korea wrongfully argue that the NLL is a "ghost line" that was established not based on the international law. However, one should note that the waters south of the NLL has always been under South Korea's jurisdiction since Korea's independence from Japan on August 15, 1945. There is no need to ask North Korea's approval for declaring the territorial waters that had already been under our sovereign jurisdiction. We do not need North Korea's approval just as we do not need Japan's approval with regard to our sovereign right over Dokdo. The legal status of the NLL may be explained with the following three characteristics. First, the NLL is a de facto maritime borderline that defines the territorial waters under the respective jurisdiction of the two divided countries. Second, the NLL in the West Sea also serves as a de facto military demarcation line at sea that can be likened to the border on the ground. Third, as a contacting line where the sea areas controlled by the two Koreas meet, the NLL is a maritime non-aggression line that was established on the legal basis of the 'acquiescence' element stipulated by the Inter-Korea Basic Agreement (article 11) and the Supplement on the Non-aggression principle (article 10). Particularly from the perspective of the domestic law, the NLL should be understood as a boundary defining areas controlled by temporarily divided states (not two different states) because the problem exists between a legitimate central government (South Korea) and an anti-government group (North Korea). In this sense, the NLL problem should be viewed not in terms of territorial preservation or expansion. Rather, it should be understood as a matter of national identity related to territorial sovereignty and national pride. North Korea's continuous efforts to problematize the NLL may be part of its strategy to nullify the Armistice Treaty. In other words, North Korea tries to take away the basis of the NLL by abrogating the Armistice Treaty and creating a condition in which the United Nations Command can be dissolved. By doing so, North Korea may be able to start the process for the peace treaty with the United States and reestablish a maritime line of its interest. So, North Korea's rationale behind making the NLL a disputed line is to deny the effectiveness of the NLL and ask for the establishment of a new legal boundary. Such an effort should be understood as part of a strategy to make the NLL question a political and military dispute (the similar motivation can be found in Japan's effort to make Dokdo a disputed Island). Therefore, the South Korean government should not accommodate such hidden intentions and strategy of North Korea. The NLL has been the de facto maritime border (that defines our territorial waters) and military demarcation line at sea that we have defended with a lot of sacrifice for the last sixty years. This is the line that our government and the military must defend in the future as we have done so far. Our commitment to the defense of the NLL is not only a matter of national policy protecting territorial sovereignty and jurisdiction; it is also our responsibility for those who were fallen while defending the North-Western Islands and the NLL.

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Fandom as a Prosumer : Study on Information Behavior of Fandom (프로슈머로서의 팬덤: 팬덤의 정보행동에 관한 연구)

  • Lee, So Young;Kim, Hyang Mi;Chu, Kyounghee;Seo, Jungchi
    • Journal of Digital Convergence
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    • v.11 no.12
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    • pp.747-759
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    • 2013
  • This study posits the activities of the fandom as information behavior: information producing, information diffusion, information sharing. The authors identify the underlying motivation and needs which lead fandom to these behavior on the basis of contents theory. In particular, the manner in which the those needs influence the information behavior of fandom is explored. The data used in this study came from various Fan Caf$\acute{e}$s which are communities of star fan. The results from the survey shows that the fandom is a kind of culture closely connected to social needs. Fandom can be viewed as an important driving force in the entertainment industry as they are co-creating the value in entertainment market.

A Normative Review on Non-Invasive Prenatal Diagnosis (NIPD): Focusing on the German Discussion on PrenaTest®

  • Kim, Na-Kyoung
    • Development and Reproduction
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    • v.25 no.2
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    • pp.113-121
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    • 2021
  • This article aims to introduce German discussion on the approval of the non-invasive prenatal diagnosis (NIPD), which started with the development of PrenaTest® by LifeCodexx AG. The discussion started with the concern that the non-invasive nature of NIPD, such as PrenaTest®, may rapidly expand the use and scope of similar tests, thus leading to a new era of eugenics. Based on this concern, the need for clear clinical guidelines on specific indications for NIPD has been suggested. Along the same line, it was discussed whether PrenaTest® is against the Basic Law prohibiting discrimination on grounds of disability and whether the test is outside the scope of the purpose of gene testing limited by Genetic Diagnosis Act. Through such discussion, the Federal Ministry of Health of Germany established the preconditions for inclusion of NIPD in the German public health insurance system. For this, the German motherhood guideline was amended and the information for the insured persons provided to pregnant women was included in the amended guideline. Such discussion made in Germany provides insight on which points should be considered when various gene testings are accepted in Korea, in which genetic communication has not been systematized yet. In particular, German counseling system for pregnant women will provide valuable insights for Korea where the direction for regulations on abortion has not been established even after the ruling by the Constitutional Court that charges for abortion are against the constitution.