• 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.

• Childhood Kidney Diseases
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• v.18 no.1
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• pp.29-35
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• 2014

Introduction: Persistent vesicoureteral reflux (VUR), a major cause of urinary tract infection (UTI) in children, can result in serious renal complications, such as reflux nephropathy and chronic renal failure. We evaluated the clinical characteristics and prognostic factors of VUR. Methods: From December 1993 to May 2011, we examined 117 children with vesicoureteral reflux who were admitted to the Department of Pediatrics and Urology, Chungbuk National University hospital for a UTI. The patients were managed medically or surgically. Results: Male patients had a slightly higher prevalence of VUR than female patients (55%). The degrees of the 161 refluxing ureters, as classified by the International Reflux Study Committee, were as follows: grade I, 15 ureters; grade II, 32 ureters; grade III, 54 ureters; grade IV, 26 ureters; grade V, 34 ureters. One hundred and sixty-one renal units (115 cases) underwent a 99m TC-DMSA renal scan, and 62% showed abnormal findings. The incidence of renal cortical defects showed a direct correlation with the severity of VUR. Ninety-four refluxing ureters were followed up medically, and 66 ureters (67%) either disappeared or improved. However, 9 refluxing ureters persisted. The spontaneous resolution rate of VUR seemed to be higher in younger patients with lower grades of reflux, and without renal cortical defects. Sixty-seven refluxing ureters (41%) were treated surgically, 62 refluxing ureters (92%) disappeared, and 5 refluxing ureters (8%) persisted. Conclusion: The incidence of renal cortical defects in patients with UTIs was 62% (in a 99m TC-DMSA renal scan), and showed a direct correlation with the severity of VUR. The spontaneous resolution rate seemed to be lower in the patients with higher grades of VUR, older age (over 4 years old) and diffuse renal cortical defects.

• Journal of radiological science and technology
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• v.34 no.1
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• pp.27-33
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• 2011

Along with the developments of science technology, up-to-date medical radiation equipments are introduced. Those equipments has brought many progresses in diagnosing patients not only in the quantitative aspects but in the qualitative ones. Especially, in the case of dental radiography, patients can be exposed more than CT, cone beam computed tomography (CBCT). In this study, we used human phantom and TLD-100H to measure the organ dose in each dental radiography and computed the effective dose according to ICRP (International Committee for Radioactivity Prevention) 60, 103. We measured the effective dose to be 5.1 and $29.5{\mu}Sv$ in the panoramic radiography and 11.2 and $14.4{\mu}Sv$ in the cephalometric radiography respectively. We also executed the CBCT and CT test on the maxillaries and the mandibles and found the amounts of effective dose were 53.7, 209.6, 129, and $391.5{\mu}Sv$ respectively in the CBCT and $93.3{\mu}$, 139.5, 282.7 and $489.7{\mu}Sv$ in the CT test. Consequently, it was shown that the effective dose in the CBCT test was lower than one in the CT test, but was higher in both panoramic and cephalometric radiography.

• Journal of radiological science and technology
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• v.35 no.4
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• pp.299-308
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• 2012

To perform patient dose surveys in major interventional radiography procedures as a mean of inter-institutional comparison and of establishing reference dose levels with the ultimate goal of optimizing patient doses in the field of interventional radiography. We reviewed international patient dose survey data in the literature and measured patient dose in major interventional radiography procedures (TACE, AVF, PTBD, TFCA, GDC embolization). ESD(Entrance Skin Dose) was measured using TLD chips attached to the patient skin and ED(Effective Dose) was calculated using angiography unit-derived DAP. A survey of patient dose in interventional radiography procedures were also performed with a questionnaire for interventional radiologists and we proposed a guideline for optimizing patient doses in the field of interventional radiology. The patient dose survey data in interventional radiography procedures were very rare in literature compared with those in diagnostic radiography procedures. In TACE, the mean ED was 25.43 mSv and the mean ESD was 511.75 mGy. The mean ED of TACE was not high, but the cumulative dose should be checked, due to longer procedure TACE. In TFCA, the mean ED was 22.6 mSv and it was relatively high compared with data of other countries. In GDC embolization, the mean ED was not available, because GDC embolization was performed with old Image-Intensifier-type unit and there has no unit-installed ionization chamber. Also, the mean ESD of GDC embolization was up to 2,264 mGy and further studies are needed to calculate the net ED of GDC embolization. Patient dose occurred during interventional radiography procedures are high related with the difficulty of the procedure, fluoroscopy time, the number of angiographies and the treatment protocol. Therefore, continuous education and efforts should be made to optimize the patient dose in the field of interventional radiology.

• Journal of Food Hygiene and Safety
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• v.23 no.4
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• pp.297-303
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• 2008

Naringin, major citrus flavonoids, has been identified to exert antioxidative, antidiabetic, and lipid lowering effects. In this study, we examined the effect of 0.2 g/kg, 0.5 g/kg naringin supplementation for 3 times/week for 5 weeks on lipid metabolism and antithrombotic capacity in rat. Eighteen five week-old Sprague Dawley(SD) female rats, which had initial body weights of $246{\pm}9g$, were randomly divided into three groups: Control (non naringin group); Low (0.2 g/kg naringin-supplemented group); High (0.5 g/kg naringin-supplemented group). Three groups of rats were supplemented with three experimental diets for 5 weeks and we investigated antithrombotic capacity before sacrifice. Naringin did not significantly alter the body weight gain, relative organ weight. However, the level of serum triglyceride, serum free fatty acid, serum total lipid and serum glucose levels were significantly lowered compared to those of control. The high group (0.5 g/kg naringin-supplemented group) was showed significantly increased bleeding time compared to control group. These results suggest that naringin supplemental diets reduces the level of hypertension, glycosuria and fatness on the female SD rats, when orally administered below the dosage 0.5 g/kg for 5 weeks.

• Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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• v.14 no.4
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• pp.343-356
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• 2016

The Korea Radioactive Waste Agency (KORAD) has developed a dual-purpose metal cask for the dry storage of spent nuclear fuel that has been generated by domestic light-water reactors. The metal cask was designed in compliance with international and domestic technology standards, and safety was the most important consideration in developing the design. It was designed to maintain its integrity for 50 years in terms of major safety factors. The metal cask ensures the minimization of waste generated by maintenance activities during the storage period as well as the safe management of the waste. An activation evaluation of the main body, which includes internal and external components of metal casks whose design lifetime has expired, provides quantitative data on their radioactive inventory. The radioactive inventory of the main body and the components of the metal cask were calculated by applying the MCNP5 ORIGEN-2 evaluation system and by considering each component's chemical composition, neutron flux distribution, and reaction rate, as well as the duration of neutron irradiation during the storage period. The evaluation results revealed that 10 years after the end of the cask's design life, $^{60}Co$ had greater radioactivity than other nuclides among the metal materials. In the case of the neutron shield, nuclides that emit high-energy gamma rays such as $^{28}Al$ and $^{24}Na$ had greater radioactivity immediately after the design lifetime. However, their radioactivity level became negligible after six months due to their short half-life. The surface exposure dose rates of the canister and the main body of the metal cask from which the spent nuclear fuel had been removed with expiration of the design lifetime were determined to be at very low levels, and the radiation exposure doses to which radiation workers were subjected during the decommissioning process appeared to be at insignificant levels. The evaluations of this study strongly suggest that the nuclide inventory of a spent nuclear fuel metal cask can be utilized as basic data when decommissioning of a metal cask is planned, for example, for the development of a decommissioning plan, the determination of a decommissioning method, the estimation of radiation exposure to workers engaged in decommissioning operations, the management/reuse of radioactive wastes, etc.

• Journal of Preventive Medicine and Public Health
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• v.14 no.1
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• pp.65-74
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• 1981

This survey was made to determine the overall health situation on (1) the status of sickness; (2) the medical care utilization; (3) the medical cost in Mi-Kum Myun, Nam Yang Ju Gun, Kyung-Gi Do. The survey with questionnaire was carried out with 2,840 peoples in 560 households from August 9th to 16th, 1979. The findings from the survey were as follows; 1. Annual morbidity rate of the prolonged ill cases was 97.2 per 1,000 population (male 94.7, female 99.6), The highest age specific morbidity rate was 274.5 of the 45-to 64-year group and the lowest was 21.9 of the 5-to 14-year group. 2. Annual morbidity rate of the new patients was 777.5 per 1,000 population(male 644.5, female 909.5). 3. The chief complaints distribution of the prolonged ill cases was: local pain 36.6%, indigestion 22.4%, and coughing 7.3%, respectively, In terms of age and sex distribution, a large number of female of the 45-to 64-year group complained of local pain or general pain and a large number of both sexes of the 25-to 44-year group complaned of indigestion. 4. The major diseases of the new patients which classified with International Classfication of Diseases (I.C.D.) were disease of the respiratory system, disease of the digestive system, and disease of the musculo-skeletal system and connective tissue for male, disease of the respiratory system, disease of the digestive system, and accident, poisoning, violence for female. 5. Total ill days of the 92 new patients were 536 days and average ill days per case were $6{\pm}38.3$ days. 6. The rate of receiving treatment in the prolonged ill cases was 82.2%(medical facilities 46.4%, drug stores 27.5%, herb medicine 8.3%). 7. The rate of receiving treatment by first choice of the new patients was 88.0% (drug stores 57.%, medical facilities 28.2%, and herb medicine 2.2%), and the rate of receiving treatment by second choice was 30.9% of first treatment cases (medical facilities 44.0%, drug store 44.0% and herb meicine 12.0%). 8. Annual hospitalization rate per 1,000 population was 12.0 (male 12.0, female 11.9). 9. The locations of medical facilities utilized by out-patients were: in the prolonged ill cases Seoul or other places 66.4%, Nam Yang Ju Gun 33.6%, in cases of the new patients Seoul or other places 35.1% and Nam Yang Ju Gun 64.9% respectively. 10. The satisfaction rate of the new patients by mode of receiving treatment was: in cases of primary utilization by first choice herb medicine 100.0%, medical facilities 88.5%, and drug stores 69.8%, in cases of secondary utilization medical facilities 100.0%, herb medicine 100.0%, and drug stores 72.7% respectively. 11. The medical cost per utilized facilities was as follows; in average medical fee per case out-patient 8.947 won, in-patient 266,000 won, drug stores 1,532 won, and herb medicine 15,607 won, in average medical fee per day out-patient 4,829 won, in patient 14,178 won, drug stores 891 won, and herb medicine 4,906 won respectively. 12. The sources of the hospital charges paid out were: there own expense 50.0%, debt 35.3%, and security of medical care 14.7% respectively.

• International Journal of Highway Engineering
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• v.12 no.2
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• pp.17-23
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• 2010

Since the relatively stiff binder shows a higher tensile strength as well as higher rutting resistance, it is believed that the binder stiffness is an important factor for rutting and tensile strength of asphalt mixtures. The typical tensile property is measured by indirect tensile strength (ITS) test at $25^{\circ}C$ and the rutting resistance is most widely measured by wheel tracking (WT) test at $60^{\circ}C$. The deformation strength ($S_D$) is newly developed property to estimate rut resistance of asphalt concretes at $60^{\circ}C$. The ITS and $S_D$ are very simple to measure by static test techniques, but the WT is measured by repeated loading procedure which requires relatively longer time and more efforts. Since these three properties are highly dependent upon the binder stiffness, it may be possible to estimate one property from another. Therefore, this study investigate the possibility of estimating the rutting characteristics (measured by WT test) by ITS or $S_D$ test, and the ITS by $S_D$. Because of binder stiffness effect, in the WT estimation by ITS, a tendency was observed for the higher ITS mixture to have the lower rut depth, giving $R^2{\fallingdotseq}$0.6, on the average. The ITS estimation by $S_D$ showed $R^2{\fallingdotseq}$0.64, and the WT estimation by SD showed $R^2{\fallingdotseq}$0.84, which is highest correlation among the three. Therefore, it was concluded that there is relatively good possibility of estimating WT result by $S_D$, and even though $R^2$ is somewhat low, there is some correlation between WT and ITS.

• Tunnel and Underground Space
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• v.30 no.4
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• pp.320-334
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• 2020

This study presents an application of hydro-mechanical coupled Particle Flow Code 3D (PFC3D) to simulation of fluid injection induced fault slip experiment conducted in Mont Terri Switzerland as a part of a task in an international research project DECOVALEX-2019. We also aimed as identifying the current limitations of the modelling method and issues for further development. A fluid flow algorithm was developed and implemented in a 3D pore-pipe network model in a 3D bonded particle assembly using PFC3D v5, and was applied to Mont Terri Step 2 minor fault activation experiment. The simulated results showed that the injected fluid migrates through the permeable fault zone and induces fault deformation, demonstrating a full hydro-mechanical coupled behavior. The simulated results were, however, partially matching with the field measurement. The simulated pressure build-up at the monitoring location showed linear and progressive increase, whereas the field measurement showed an abrupt increase associated with the fault slip We conclude that such difference between the modelling and the field test is due to the structure of the fault in the model which was represented as a combination of damage zone and core fractures. The modelled fault is likely larger in size than the real fault in Mont Terri site. Therefore, the modelled fault allows several path ways of fluid flow from the injection location to the pressure monitoring location, leading to smooth pressure build-up at the monitoring location while the injection pressure increases, and an early start of pressure decay even before the injection pressure reaches the maximum. We also conclude that the clay filling in the real fault could have acted as a fluid barrier which may have resulted in formation of fluid over-pressurization locally in the fault. Unlike the pressure result, the simulated fault deformations were matching with the field measurements. A better way of modelling a heterogeneous clay-filled fault structure with a narrow zone should be studied further to improve the applicability of the modelling method to fluid injection induced fault activation.

• International Journal of Highway Engineering
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• v.12 no.2
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• pp.107-113
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• 2010

In this study, the relative effects of low-chloride deicier(LCD) and two other deicing agents on the scaling of concrete were conducted in a series of tests at laboratory accordance with the ASTM C 672. The solutions concentration of deicers tested included 1, 4, 10%. Tap water was used as control. The amount of scaling was evaluated gravimetrically. As test result of deicer solution types, when applied to 4% solutions, surface scaling of concrete after 56 freeze-thaw cycles was produced significantly as about 9 times on LCD solution, as about 18 times on $CaCl_2$ solution, and as about 33 times on NaCl solution comparing with tap water. As test result of deicer solution concentrations, relatively low concentrations (of the 4% by weight) of deicer were produced more surface scaling than higher concentrations (of the 10% by weight) or lower concentrations (of the 1% by weight) of deicer. It show that the damaging concentration is of the order of 3~4% for previous research result. It appears that the mechanism of surface scaling is primarily physical rather than chemical. Also, the effect of chloride deicier types, freeze-thaw cycling, and air contents on the performance of concrete was experimentally investigated. The results show that the concrete specimens subjected to freeze-thaw cycling scaled more severely in exposure to deicing salt than those in non-exposure to deicing salt, weight losses of the specimens tested in exposure to deicing salt were twice as much as those tested in non-exposure to deicing salt. Relative dynamic modulus of elasticity of concrete specimens decreased more quickly in exposure to deicing salt than in non-exposure to deicing salt. Also, relative dynamic modulus of elasticity of concrete specimens in exposure to sodium chloride deicing salt was decreased more quickly comparing with exposure to LCD salt. It is also shown that the chloride contents according to concrete specimen depths was more largely in exposure to LCD salt. When concrete specimen is exposed to chloride deicing salts and freeze-thaw cycling, performance degradation in the entrained air concrete(AE concrete) retarded more considerably comparing with non-entrained air concrete(Non-AE concrete).