• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.223-259
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• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• Proceedings of the Korea Society of Poultry Science Conference
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• 2003.07b
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• pp.37-54
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• 2003

It has been recognized that the hen. like its mammalian counterparts. provides young chicks with antibodies as protection against hostile invaders. This system facilitates the transfer of specific antibodies from serum to egg yolk. and provides a supply of antibodies called immunoglobulin Y(IgY) to the developing embryo and the hatched chick. The protection against pathogens that the relatively immuno-incompetent newly hatched chick has. is through transmission of antibodies from the mother via the egg. Egg yolk. therefore. can be loaded with a large amount of IgY against pathogens which can immobilize the existing or invading pathogens during the embryo development or in day-old chicks. Thus. the immunization of laying hens to various pathogens results in production of different antigen-specific IgY in eggs. Egg yolk contains 8~20 mg of immunoglobulins (IgY) per $m\ell$ or 136~340 mg per yolk suggesting that more than 30 g of IgY can be obtained from one immunized hen in a year. By immunizing laying hens with antigens and collecting IgY from egg yolk. low cost antibodies at less than ＄10 per g compared to more than ＄20.000 per g of mammalian IgG can be obtained. This IgY technology opens new potential market applications in medicine. public health veterinary medicine and food safety. A broader use of IgY technology could be applied as biological or diagnostic tool. nut-raceutical or functional food development. oral-supplementation for prophylaxis. and as pathogen-specific antimicrobial agents for infectious disease control. This paper has emphasized that when IgY-loaded chicken eggs are produced and consumed. the specific antibody binds. immobilizes and consequently reduces or inhibits the growth or colony forming abilities of microbial pathogens. This concept could serve as an alternative agent to replace the use of antibiotics. since today. more and more antibiotics are less effective in the treatment of infections. due to the emergence of drug-resistant bacteria.

• Journal of Digital Convergence
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• v.19 no.7
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• pp.57-70
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• 2021

As COVID-19 spreads, people's interest in smart learning that can do non-face-to-face learning is increasing nowadays. In this study, we aim to empirically analyze how users' thoughts on COVID-19 and the information quality and system quality of smart learning systems affect users' acceptance of smart learning and examine the effect of perceived sensitivity and severity of COVID-19 on the satisfaction and use of smart learning through concerns about the risk of transmission. In addition, we examined the influence of information quality composed of content quality and interaction quality and system quality composed of system accessibility and functionality on the use of smart learning through user satisfaction. To verify the validity of the proposed model, we conducted a survey on 334 users with experience in using smart learning, and performed the analysis using Smart PLS 3.0. According to the analysis results, among information quality and system quality, only functionality has a positive (+) effect on the satisfaction of smart learning, and satisfaction has a positive (+) effect on the usage behavior. However, it is found that accessibility among system quality do not affect satisfaction, and concern about the risk of transmission has a negative effect on satisfaction. This study can provide meaningful guidelines to researchers when researching smart learning to support students' learning in a pandemic situation of a new infectious disease, such as COVID-19. It will also be able to provide useful implications for educational institutions and companies related to smart learning.

• Journal of Preventive Medicine and Public Health
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• v.25 no.1 s.37
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• pp.88-100
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• 1992

This study was conducted to assess the effects of implementation of the patient referral system started July 1st, 1989. A comparison on the pattern of outpatient services of the Departments of Internal Medicine, General Surgery, and Pediatrics at the Yeungnam University Hospital was conducted for each one year period before and after implementation of the patient referral system. The pre-implementation period was from July 1, 1988 to June 30, 1989 and the post-implementation period was from July 1, 1989 to June 30, 1990. The information used for this study was obtained from official forms, prepared by the Yeungnam University Hospital, and submitted to the Korean Medical Insurance Cooperatives. After implementation of the patient referral system, the number of outpatient cases in the Department of Internal Medicine decreased 36.1% from 9,669 cases to 6,181 cases a year. Cases in the Department of General Surgery decreased 23.7% from 1,864 cases to 1,422 cases a year. The number of cases in the Department of Pediatrics decreased 36.9% from 3,372 cases to 2,128 cases a year. After implementation of the patient referral system, the average age of cases in the Departments of Internal Medicine and General Surgery was 52.5 and 49.7 years old, respectively. This was a significant increase in comparison with the pre-implementation period. After implementation of patient referral system, the proportion of new outpatients in the Department of Internal Medicine decreased from 24.1% to 14.6%, the Department of General Surgery from 36.0% to 23.4%, and the Department of Pediatrics from 15.5% to 8.3%. The number of visits per case decreased significantly in the Department of Internal Medicine(from 1.74 to 1.61), but there was no significant change in the Departments of General Surgery and Pediatrics. The length of treatment per case increased significantly in all three departments(from 16.1 days to 19.3 days in the Department of Internal Medicine, from 12.0 days to 15.2 days in the Department General Surgery, and 8.9 days to 11.2 days in the Department of Pediatrics). The number of clinical tests per case increased significantly in the Department of Internal Medicine (from 2.2 to 2.5), in the Department of Pediatrics(from 0.8 to 1.1) and increased in the Department of General Surgery(from 6.4 to 6.6). The average medical cost per case decreased from 43,900 Won to 42,500 Won in the Department of Internal Medicine, while the cost increased from 75,900 Won to 78,500 Won in the Department of General Surgery and from 12,700 Won to 13,500 Won in the Department of Pediatrics. In case-mix, the chronic degenerative disease(i. e. hypertension, diabetes mellitus, angina pectoris, malignant neoplasm, and pulmonary tuberculosis) ranked higher and acute infectious diseases and simple cases(i. e. gastritis and duodenitis, haemorrhoids, anal fissure, carbuncle, acute URI, and bronchitis) ranked lower after implementation of the patient referral system compared to before implementation.