• 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.

• Journal of the Korean Society of Radiology
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• v.14 no.4
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• pp.467-475
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• 2020

The purpose of this study is to assess doses to ¹⁸F-FDG, a radioactive drug, during PET examinations, to alleviate anxiety about radiation in patients and carers, to minimize the indiscriminate examination progress caused by medical institution personnel and space clearance problems, and health examination. The dose assessment was measured using a thermo-fluorescent dosimeter (TLD) and an electronic personal dosimeter (EPD) at the location of the cervical (hypothyroid), thorax (heart), and lower abdomen (breeding line) which are the three highest tissue areas of the radiation tissue weighting. In addition, spatial dose rates and radioactivity in urine were measured using GM counters and ion boxes. The results are as follows: First, the personal dosimeter TLD was measured 0.0425±0.0277 mSv in the cervical region, 0.0440±0.0386 mSv in the thorax and 0.0485±0.0436 mSv in the lower abdomen, with little difference in the heart dose depending on radiation sensitivity. The EPD was measured at 0.942±0.141 mSv/h immediately after the cervical position, and 0.192±0.031 mSv/h after 120 minutes. Immediately after the thorax position, 0.516±0.085 mSv/h, 120 minutes later 0.128±0.040 mSv/h. Immediately after the lower abdomen position, 0.468±0.091 mSv/h, and after 120 minutes 0.105±0.021 mSv/h were measured. The spatial dose rate at the GM counter was measured immediately at 0.041±0.005 mSv/h, 120 minutes later at 0.014±0.002 mSv/h. The radioactivity in urine using ion chamber was measured at 0.113±0.24 MBq/cc after 60 minutes and 0.063±0.13 MBq/cc after 120 minutes. As a result, ¹⁸F-FDG should be administered, dose re-evaluated two hours after the PET test is completed, and caregivers should be avoided. In addition, it is deemed necessary to provide patients and carers with sufficient explanations and expected values of exposure dose to avoid reckless testing. It is hoped that the data tested in this study will help patients and families relieve anxiety about radiation, and that the radiation workers' exposure management system and institutional improvements will contribute to the development of medical radiation.

• The Korean Journal of Emergency Medical Services
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• v.22 no.1
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• pp.7-19
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• 2018

Purpose: With the purpose of educating and producing outstanding paramedics by enhancing their competencies, this study aimed to make policy suggestions to re-establish the education system and improve the national examination and the certification scheme. Methods: This study used focus group interviews and questionnaires to collect data. Totally, there were 277 subjects, including experts from the education and field. Data were collected from September 9 to 20, 2016, and analyzed using SPSS 22.0. Results: To strengthen the curriculum of paramedics, this study suggested 27 courses with 94 credits as the standardized curriculum and derived 9 core competencies of paramedics. For the national examination, this study suggested consolidating written test subjects, adding scenario questions to practical tests, and applying critical criteria to simple practical tests that performs a procedure, grading these tests on a pass/fail basis. In addition, this study suggested converting certification into license, reflecting paramedics' healthcare job characteristics. Conclusion: The quality of emergency medical services in Korea will improve when those with core competencies that originated from the standardized curriculum based on the results of this study acquire their certification through the national test scheme, and the certification management system creates a virtuous cycle to further enhance paramedics' professionalism.

• Journal of Veterinary Clinics
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• v.28 no.5
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• pp.486-496
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• 2011

A special mesenchymal tissue layer called perichondrium has a chondrogenic capacity and is a candidate tissue for engineering of cartilage. To overcome limited potential for chondrocyte proliferation and re-absorption, we studied a method of cartilage tissue engineering comprising chondrocyte-hydrogel pluronic complex (CPC) and cultured perichondrial cell sheet (cPCs) which entirely cover CPC. For effective cartilage regeneration, cell-sheet engineering technique of high-density culture was used for fabrication of cPCs. Hydrogel pluronic as a biomimetic cell carrier used for stable and maintains the chondrocytes. The human cPCs was cultured as a single layer and entirely covered CPC. The tissue engineered constructs were implanted into the dorsal subcutaneous tissue pocket on nude mice (n = 6). CPC without cPCs were used as a controls (N = 6). Engineered cartilage specimens were harvested at 12 weeks after implantation and evaluated with gross morphology and histological examination. Biological analysis was also performed for glycosaminoglycan (GAG) and type II collagen. Indeed, we performed additional in vivo studies of cartilage regeneration using canine large fullthickness chondrial defect model. The dogs were allocated to the experimental groups as treated chondrocyte sheets with perichondrial cell sheet group (n = 4), and chondrocyte sheets only group (n = 4). The histological and biochemical studies performed 12 weeks later as same manners as nude mouse but additional immunofluorescence study. Grossly, the size of cartilage specimen of cPCs covered group was larger than that of the control. On histological examination, the specimen of cPCs covered group showed typical characteristics of cartilage tissue. The contents of GAG and type II collagen were higher in cPCs covered group than that of the control. These studies demonstrated the potential of such CPC/cPCs constructs to support chondrogenesis in vivo. In conclusion, the method of cartilage tissue engineering using cPCs supposed to be an effective method with higher cartilage tissue gain. We suggest a new method of cartilage tissue engineering using cultured perichondrial cell sheet as a promising strategy for cartilage tissue reconstruction.

• Journal of Korean Classical Literature and Education
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• no.32
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• pp.327-355
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• 2016

This study aims to identify petit bourgeois desires through the characters in "Oksosun Stories" from Cheonyerok, an eighteenth-century Yadam anthology. The desires and motivations of the characters are quite secular and egocentric. Because of this, their shared characteristics are similar to those of the petit bourgeois, as neutral existence begins to emerge during the transition from feudal to modern society. The concept of petit bourgeois generally means the public and the working class of modern society. The main character's behavior in the story differs little from general petit bourgeois attitudes. An important belief in petit bourgeois is not the ruling ideology in society but the achievement and stability of realistic and ordinary desires to fulfill their lives' satisfaction. Also selfish or antisocial attitudes and boundary characteristics appear in the process, depending on whether subject having any desire. However, the character's actions are limited in the governance system of a huge reality. And It is characterized by end goal being to meet their upward mobility and stability. This corresponds with Seang's (書生) actions of turning his back on his family and country as well as promising Jaran his love; and, he redeems himself with his family and society by acquiring stability after he passed the state examination. Furthermore, the contemporary significance of this work demonstrates Seang (書生) discovering his desires for human love; therefore, in order to affirm and gratify this desire, he endures the societal state of semi-feudalism against filial duty (不孝), disloyalty (不忠), and non-chastity (不烈), and he acts independently. In addition, on the strength of his pursuit of his desires, Oksosun frees herself from the caste restraint called gisaeng (妓生) and affirms her desire to become a subject of love, but she then deviates from the social system. Moreover, the limitations and achievements of the petit bourgeois are indicated in the actions of recognizing the social threshold of their past in the process, making independent efforts using their capabilities, fulfilling success in the state examination with their intellectual capacity, and re-entering society. From the late Chosun Dynasty to modern times, there is not only the type of contemporary people who hunger for fulfillment of their personal desire and live in free will, but there is also the feudal type that is still lacking in the understanding of independent life. This is not as different as in these present times. This literature asserts the meaning of awakening one's self-existence and assigning great value to the fulfillment of self-desires against the odds that are created by socio-political, cultural, economic norms of the era. "Oksosun Story" affirms the small efforts and successes of private individuals in reality. It also validates the search for life happiness through positivity. In this sense, even the contemporary reader would derive valid meaningfulness from this literature.

• Korean Journal of Fisheries and Aquatic Sciences
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• v.28 no.2
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• pp.183-193
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• 1995

Assuming that fishing nets are porous structures to suck water into their mouth and then filtrate water out of them, the flow resistance N of nets with wall area S under the velicity v was taken by $R=kSv^2$, and the coefficient k was derived as $$k=c\;Re^{-m}(\frac{S_n}{S_m})n(\frac{S_n}{S})$$ where $R_e$ is the Reynolds' number, $S_m$ the area of net mouth, $S_n$ the total area of net projected to the plane perpendicular to the water flow. Then, the propriety of the above equation and the values of c, m and n were investigated by the experimental results on plane nettings carried out hitherto. The value of c and m were fixed respectively by $240(kg\cdot sec^2/m^4)$ and 0.1 when the representative size on $R_e$ was taken by the ratio k of the volume of bars to the area of meshes, i. e., $$\lambda={\frac{\pi\;d^2}{21\;sin\;2\varphi}$$ where d is the diameter of bars, 21 the mesh size, and 2n the angle between two adjacent bars. The value of n was larger than 1.0 as 1.2 because the wakes occurring at the knots and bars increased the resistance by obstructing the filtration of water through the meshes. In case in which the influence of $R_e$ was negligible, the value of $cR_e\;^{-m}$ became a constant distinguished by the regions of the attack angle $ \theta$ of nettings to the water flow, i. e., 100$(kg\cdot sec^2/m^4)\;in\;45^{\circ}<\theta \leq90^{\circ}\;and\;100(S_m/S)^{0.6}\;(kg\cdot sec^2/m^4)\;in\;0^{\circ}<\theta \leq45^{\circ}$. Thus, the coefficient $k(kg\cdot sec^2/m^4)$ of plane nettings could be obtained by utilizing the above values with $S_m\;and\;S_n$ given respectively by $$S_m=S\;sin\theta$$ and $$S_n=\frac{d}{I}\;\cdot\;\frac{\sqrt{1-cos^2\varphi cos^2\theta}} {sin\varphi\;cos\varphi} \cdot S$$ But, on the occasion of $\theta=0^{\circ}$ k was decided by the roughness of netting surface and so expressed as $$k=9(\frac{d}{I\;cos\varphi})^{0.8}$$ In these results, however, the values of c and m were regarded to be not sufficiently exact because they were obtained from insufficient data and the actual nets had no use for k at $\theta=0^{\circ}$. Therefore, the exact expression of $k(kg\cdotsec^2/m^4)$, for actual nets could De made in the case of no influence of $R_e$ as follows; $$k=100(\frac{S_n}{S_m})^{1.2}\;(\frac{S_m}{S})\;.\;for\;45^{\circ}<\theta \leq90^{\circ}$$, $$k=100(\frac{S_n}{S_m})^{1.2}\;(\frac{S_m}{S})^{1.6}\;.\;for\;0^{\circ}<\theta \leq45^{\circ}$$

• Korean Journal of Heritage: History & Science
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• v.55 no.2
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• pp.200-211
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• 2022

The celadon stools with an openwork ring design which consist of four items as one collection were excavated from Gaeseong, Gyeonggi-do Province. The celadon stools were designated and managed as treasures due to their high arthistorical value in the form of demonstrating the excellence of celadon manufacturing techniques and the fanciful lifestyles during the Goryeo Dynasty. However, one of the items, which appeared to have been repaired and restored in the past, suffered a decline in aesthetic value due to the aging of the treatment materials and the lack of skill on the part of the conservator, raising the need for re-treatment as a result of structural instability. An examination of the conservation condition prior to conservation treatment found structural vulnerabilities because physical damage had been artificially inflicted throughout the area that was rendered defective at the time of manufacturing. The bonded surfaces for the cracked areas and detached fragments did not fit, and these areas and fragments had deteriorated because the adhesive trickled down onto the celadon surface or secondary contaminants, such as dust, were on the adhesive surface. The study identified the position, scope, and conditions of the bonded areas at the cracks UV rays and microscopy in order to investigate the condition of repair and restoration. By conducting Fourier-transform infrared spectroscopy(FT-IR) and portable x-ray fluorescence spectroscopy on the materials used for the former conservation treatment, the study confirmed the use of cellulose resins and epoxy resins as adhesives. Furthermore, the analysis revealed the addition of gypsum(CaSO₄·2H₂O) and bone meal(Ca₁₀ (PO₄)₆(OH)₂) to the adhesive to increase the bonding strength of some of the bonded areas that sustained force. Based on the results of the investigation, the conservation treatment for the artifact would focus on completely dismantling the existing bonded areas and then consolidating vulnerable areas through bonding and restoration. After removing and dismantling the prior adhesive used, the celadon stool was separated into 6 large fragments including the top and bottom, the curved legs, and some of the ring design. After dismantling, the remaining adhesive and contaminants were chemically and physically removed, and a steam cleaner was used to clean the fractured surfaces to increase the bonding efficacy of the re-bonding. The bonding of the artifact involved applying the adhesive differently depending on the bonding area and size. The cyanoacrylate resin Loctite 401 was used on the bonding area that held the positions of the fragments, while the acrylic resin Paraloid B-72 20%(in xylene) was treated on cross sections for reversibility in the areas that provided structural stability before bonding the fragments using the epoxy resin Epo-tek 301-2. For areas that would sustain force, as in the top and bottom, kaolin was added to Epo-tek 301-2 in order to reinforce the bonding strength. For the missing parts of the ring design where a continuous pattern could be assumed, a frame was made using SN-sheets, and the ring design was then modeled and restored by connecting the damaged cross section with Wood epos. Other restoration areas that occurred during bonding were treated by being filled with Wood epos for aesthetic and structural stabilization. Restored and filled areas were color-matched to avoid the feeling of disharmony from differences of texture in case of exhibitions in the future. The investigation and treatment process involving a variety of scientific technology was systematically documented so as to be utilized as basic data for the conservation and maintenance.

• Sleep Medicine and Psychophysiology
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• v.15 no.2
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• pp.94-99
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• 2008

The most common cause of obstructive sleep apnea syndrome (OSAS) in childhood is adenotonsillar hypertrophy. Adenotonsillectomy improves the symptoms quite well in most cases. However, some patients could experience the OSAS again after adenotonsillectomy, who might have several risk factors such as incomplete operation, misdiagnosis, combined anatomical malformation, sinusitis or chronic allergic rhinitis, obesity, initial severe OSAS, and early onset OSAS. We report a case of 11-year-old obese boy who presented with snoring for several years. He was obese with body mass index (BMI) of $26.3kg/m^2$ and also found to have fatty liver by ultrasonogram. Initial polysomnography (PSG) showed that he met the criteria of severe OSAS with the apnea-hypopnea index (AHI) of 70.5. He underwent adenotonsillectomy and symptoms improved immediately. Four months later symptoms were relieved with AHI of 0, but 1 year after the adenotonsillectomy he started to complain snoring again and the subsequent PSG results showed that OSAS has relapsed with AHI of 43. Paranasal sinus X-ray and physical examination showed sinusitis and re-growth of adenoid. Obesity was proved not to be a contributing factor because his BMI decreased to normal range ($23.1kg/m^2$) after diet control and regular exercise. Also, liver transaminase was normalized and fatty liver was disappeared on follow-up abdominal ultrasonogram. After treatment of sinusitis, symptoms were relieved with decreased AHI (8.5). This case suggests that simple adenotonsillectomy might not be the end of OSAS treatment in childhood. Patients who had adenotonsillectomy should be followed by subsequent PSG if symptoms recur. It is also important to be aware of risk factors in the recurrent OSAS for the proper intervention according to the cause.

• The Korean Journal of Nuclear Medicine Technology
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• v.14 no.2
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• pp.166-171
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• 2010

Purpose: The SPECT/CT is able to acquire diagnostic information resolved the difficult problems that discriminate regions of focals by intergrating functional images and anatomical images. We introduce the usefulness of "Volumetrix Suite" which can describe 3D images by the convergence of the SPECT/CT images and reference CT images. Materials and Methods: We applied Volumetrix Suite program (Volumetrix IR, Volumetrix 3D) to patients, Bone, Venography, Parathyroid, WBC, taken diagnostic CT examination which have same regions of focal in Seoul Metropolitan Government Seoul National University Boramae Medical Center. After acquiring SPECT/CT images and reference CT images, we fused a couple of scans applying for this programs. The CT scan of Infinia Hawkeye 4 shows limitation of anatomical information. For this reason, we tried to transfer CT images that have lots of diagnostic informations as the form of Dicom file in PACS, and changed from 2D images to 3D images after image registering in Xeleris Workstaion of Hawkeye 4. Results & Conclusion: By using Volumetrix Suite program, we're able to acquire more accurate anatomical informations with 3D rendering which can distinguish both location and range of focals in Infinia Hawkeye 4. Thus, the result of utilizing this program indicate that nuclear medicine anatomical images can be improved by providing more diagnostic imformations produced by its program.

• The Korean Journal of Nuclear Medicine
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• v.32 no.5
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• pp.403-413
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• 1998

Purpose: We investigated reproducibility of the quantification of left ventricular volume and ejection fraction, and grading of myocardial wall motion and systolic thickening when we used gated myocardial SPECT and Cedars quantification software. Materials and Methods: We performed gated myocardial SPECT in 33 consecutive patients twice in the same position after Tc-99m-MIBI SPECT We used 16 frames per cycle for the gating of sequential Tc-99m-MIBI SPECT. After reconstruction, we used Cedars quantitative gated SPECT and calculated ventricular volume and ejection fraction (EF). Wall motion was graded using 5 point score. Wall thickening was graded using 4 point score. Coefficient of variation for re-examination of volume and fraction were calculated. Kappa values (k-value) for assessing reproducibility of wall motion or wall thickening were calculated. Results: Enddiastolic volumes (EDV) ranged from 58 ml to 248 ml (122 ml +/- 42 ml), endsystolic volumes (ESV) from 20 ml to 174 ml (65 ml +/- 39 ml), and EF from 20% to 65% (51% +/- 14%). Geometric mean of standard deviations of 33 patients was 5.0 ml for EDV, 3.9 ml for ESV and 1.9% for EF. Their average differences were not different from zero (p>0.05). k-value for wall motion using 2 consecutive images was 0.76 (confidence interval: 0.71-0.81). k-value was 0.87 (confidence interval: 0.83-0.90) for assessment of wall thickening. Conclusion: We concluded that quantification of functional indices, assessment of wall motion and wall thickening using gated Tc-99m-MIBI SPECT was reproducible and we could use this method for the evaluation of short-acting drug effect.