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Gef$\ddot{a}$hrdungshaftung F$\ddot{u}r$ Arzneimittelsch$\ddot{a}$den nach dem deutschen Arzneimittelgesetz (독일 의약품법상의 의약품 위험책임)

  • Chun, Kyoung-Un
    • The Korean Society of Law and Medicine
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    • v.10 no.1
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    • pp.363-388
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    • 2009
  • i) Das deutsche Arzneimittelgesetz(AMG) vom 24. 8. 1976 hat neben der Einf$\ddot{u}$hrung des Zulassungsverfahren f$\ddot{u}$r Arzneimittel anstelle des bisherigen Registrieungsverfahrens vor allem auf dem Gebiet des Haftungsrechts eine bedeutende Neuerung gebracht: die Gef$\ddot{a}$hrdungshaftung f$\ddot{u}$r den pharmazeutischen Unternehmer. Gem$\ddot{a}{\ss}$ $\S$84 AMG ist der pharmazeutische Unternehmer zum Schadensersatz verpflichtet. wenn infolge der Anwndung eines Arzneimittels ein Mensch get$\ddot{o}$tet oder K$\ddot{o}$rper oder die Gesundheit eines Menschen nicht unerheblich verletzt wird. Pharmazeutischer Unternehmer ist, wer das Arzneimittel unter seinem Namen in Verkehr bringt. ii) Die Ersatzpflicht des pharmazeutisches Unternehmers besteht jedoch nur in zwei F$\ddot{a}$llen: a) Das Arzneimittel hat bei bestimmungsgemm$\ddot{a}{\ss}$em Gebrauch sch$\ddot{a}$dliche Wirkungen, die $\ddot{u}$ber ein nach den Erkenntnissen der medizinischen Wissenschaft vertretbares Ma$\ss$ hinausgehen($\S$84 Abs. 1 Satz 2 Nr. 1 AMG). b) Der Schaden ist infolge einer nicht den Erkenntnissen der medizinischen Wissenschaft entsprechenden Kennzeichnung, Fachinformarion oder Gebrauchsinformation eingetreten($\S$84 Abs. 1 Satz 2 Nr. 2 AMG). iii) Mit dem 2. Schadensersatzrechts$\ddot{a}$nderungsgesetz ist, dem Konzept von $\S$6 Umwelthaftungsgesetz folgend, eine gesetzliche Kausalit$\ddot{a}$tsvermutung eingef$\ddot{u}$hrt worden. Ist das angewendete Arzneimittel nach den Gegebenheiten des Einzelfalls geeignet, den entstandenen Schaden zu verursachen, so soll vermutet werden, da$\ss$ das Arzneimittel auch den konkreten Schaden beim Anwender verursacht hat($\S$84 II AMG). Der pharmazeutische Unternehmer hat dann diese Vermutung zu wiederlegen. iv) Gem$\ddot{a}{\ss}$ $\S$94 AMG hat der pharmazeutische Unternehmer f$\ddot{a}$r seine Haftpflicht Deckungsvorsorge entweder durch eine Hafpflichtversicherung oder eine Freistellungs- oder Gew$\ddot{a}$hrleistungsverpflichtung eines Inl$\ddot{a}$ndischen Kreditinstituts zu treffen. v) Aber koreanisches Arzneimittelgesetz hat keine Gef$\ddot{a}$hrdungshaftung f$\ddot{u}$r Arzneimittelschaden. Es gibt nur Gefahrdungshaftung des Hersteller aufgrund des Produkthaftungsgesetzes, das auf das Arzneimittel Anwendung findet. Ich glaube, in Zukuft soll koreanisches AMG die Gef$\ddot{a}$hrdungshaftung f$\ddot{u}$r den pharmazeutischen Unternehmer regeln.

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Study of 68Ga Labelled PET/CT Scan Parameters Optimization (68Ga 표지 PET/CT 검사의 최적화된 매개변수에 대한 연구)

  • In Suk Kwak;Hyuk Lee;Si Hwal Kim;Seung Cheol Moon
    • The Korean Journal of Nuclear Medicine Technology
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    • v.27 no.2
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    • pp.111-127
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    • 2023
  • Purpose: Gallium-68 (68Ga) is increasingly used in nuclear medicine imaging for various conditions such as lymphoma and neuroendocrine tumors by labeling tracers like Prostate Specific Membrane Antigen (PSMA) and DOTA-TOC. However, compared to Fluorine-18 (18F) used in conventional nuclear medicine imaging, 68Ga has lower spatial resolution and relatively higher Signal to Background Ratio (SBR). Therefore, this study aimed to investigate the optimized parameters and reconstruction methods for PET/CT imaging using the 68Ga radiotracer through model-based image evaluation. Materials and Methods: Based on clinical images of 68Ga-PSMA PET/CT, a NEMA/IEC 2008 PET phantom model was prepared with a Hot vs Background (H/B) ratio of 10:1. Images were acquired for 9 minutes in list mode using DMIDR (GE, Milwaukee WI, USA). Subsequently, reconstructions were performed for 1 to 8 minutes using OS-EM (Ordered Subset Expectation Maximization) + TOF (Time of Flight) + Sharp IR (VPFX-S), and BSREM (Block Sequential Regularized Expectation Maximization) + TOF + Sharp IR (QCFX-S-400), followed by comparative evaluation. Based on the previous experimental results, images were reconstructed for BSREM + TOF + Sharp IR / 2 minutes (QCFX-S-2min) with varying β-strength values from 100 to 700. The image quality was evaluated using AMIDE (freeware, Ver.1.0.1) and Advanced Workstation (GE, USA). Results: Images reconstructed with QCFX-S-400 showed relatively higher values for SNR (Signal to Noise Ratio), CNR (Contrast to Noise Ratio), count, RC (Recovery Coefficient), and SUV (Standardized Uptake Value) compared to VPFX-S. SNR, CNR, and SUV exhibited the highest values at 2 minutes/bed acquisition time. RC showed the highest values for a 10 mm sphere at 2 minutes/bed acquisition time. For small spheres of 10 mm and 13 mm, an inverse relationship between β-strength increase and count was observed. SNR and CNR peaked at β-strength 400 and then decreased, while SUV and RC exhibited a normal distribution based on sphere size for β-strength values of 400 and above. Conclusion: Based on the experiments, PET/CT imaging using the 68Ga radiotracer yielded the most favorable quantitative and qualitative results with a 2 minutes/bed acquisition time and BSREM reconstruction, particularly when applying β-strength 400. The application of BSREM can enhance accurate quantification and image quality in 68Ga PET/CT imaging, and an optimization process tailored to each institution's imaging objectives appears necessary.

A streptococcal Disease of Cultured Flounder, Paralichthys olivaceus (양식(養殖) 넙치의 연쇄구균증(連鎖球菌症))

  • Lee, Chang-Hoon;Ha, Dong-Soo
    • Journal of fish pathology
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    • v.4 no.2
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    • pp.71-77
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    • 1991
  • From August to October of 1991, a bacterial disease occurred in cultured flounder, of 0 age Paralichthys olivaceus, in Cheju-do. Typical symptoms of the diseased fish were the hemorrage of the opercle, discoloration of the body, exophthalmus and hemorrhage of the eyes. The causative organism isolated from diseased fish was identified as a $\beta$-hemolytic Streptococcus. This bacterium was not identical with any known Streptococcus species listed in Bergey's Manual of Determinative Bacteriology 8th edition. However there was a close similarity between this species and Streptococcus sp. isolated from flounder and reported by Tashio (1983). The isolated bacteria streptococcus sp. showed very high sensitivity to the SM and EM, however, it resisted to the high concentration of Penicillin. In the pathagenicity analysis, about $1.1{\times}10^9$, $1.1{\times}10^7$, $1.1{\times}10^5$, $1.1{\times}10^3$, $1.1{\times}10^1cells$/100g B.W of isolated bacteria were injected percutaneouly. The results showed that this inoculation size $1.1{\times}10^3cells$/100g B.W was the threshold for the induction of mortality in pathogenicity analysis.

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Calculation and measurement of optical coupling coefficient for bi-directional tancceiver module (양방향 송수신모듈 제작을 위한 광결합계수의 계산 및 측정)

  • Kim, J. D.;Choi, J. S.;Lee, S. H.;Cho, H. S.;Kim, J. S.;Kang, S. G.;Lee, H. T.;Hwang, N.;Joo, G. C.;Song, M. K.
    • Korean Journal of Optics and Photonics
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    • v.10 no.6
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    • pp.500-506
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    • 1999
  • We designed and fabricated a bidirectional optical transceiver module for low cost access network. An integrated chip forming a pin-PD on an 1.3 urn FP-LD was assembled by flip-chip bonding on a Si optical bench, a single mode fiber with an angled end facet was aligned passively with the integrated chip on V-groove of Si-optical bench. Gaussian beam theory was applied to evaluate the coupling coefficients as a function of some parameters such as alignment distance, angle of fiber end facet, vertical alignment error. The theory is also used to search the bottle-neck between transmittance and receiving coupling efficiency in the bi-directional optical system. Tn this paper, we confirmed that reduction of coupling efficiency by the vertical alignment error between laser beam and fiber core axis can be compensated by controlling the fiber facet angle. In the fabrication of sub-module, a'||'&'||' we made such that the fiber facet have a corn shape with an angled facet only core part, the reflection of transmitted laser beam from the fiber facet could be minimized below -35 dE in alignment distance of 2: 30 /J.m. In the same condition, transmitted output power of -12.1 dEm and responsivity of 0.2. AIW were obtained.

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Identification of Novel SNPs in Bovine Insulin-like Growth Factor Binding Protein-3 (IGFBP3) Gene

  • Kim, J.Y.;Yoon, D.H.;Park, B.L.;Kim, L.H.;Na, K.J.;Choi, J.G.;Cho, C.Y.;Lee, H.K.;Chung, E.R.;Sang, B.C.;Cheong, I.J.;Oh, S.J.;Shin, Hyoung Doo
    • Asian-Australasian Journal of Animal Sciences
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    • v.18 no.1
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    • pp.3-7
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    • 2005
  • The insulin-like growth factors (IGFs), their receptors, and their binding proteins play key roles in regulating cell proliferation and apoptosis. Insulin-like growth factor binding protein-3 (IGFBP3, OMIM #146732) is one of the proteins that bind to the IGFs. IGFBP3 is a modulator of IGF bioactivity, and direct growth inhibitor in the extravascular tissue compartment. We identified twenty-two novel single nucleotide polymorphisms (SNPs) in IGFBP3 gene in Korean cattle (Hanwoo, Bos taurus coreanae) by direct sequencing of full gene including -1,500 bp promoter region. Among the identified SNPs, five common SNPs were screened in 650 Korean cattle; one SNP in promoter (IGFBP3 G-854C), one in 5'UTR region (IGFBP3 G-100A), two in intron 1 (IGFBP3 G+421T, IGFBP3 T+1636A), and one in intron 2 (IGFBP3 C+3863A). The frequencies of each SNP were 0.357 (IGFBP3 G-854C), 0.472 (IGFBP3 G-100A), 0.418 (IGFBP3 G+421T), 0.363 (IGFBP3 T+1636A) and 0.226 (IGFBP3 C+3863A), respectively. Haplotypes and their frequencies were estimated by EM algorithm. Six haplotypes were constructed with five SNPs and linkage disequilibrium coefficients (|D'|) between SNP pairs were also calculated. The information on SNPs and haplotypes in IGFBP3 gene could be useful for genetic studies of this gene.

A Study on the Efficiency Measurement of Regional Maritime Affairs and Fisheries Office by DEA Method (DEA에 의한 지방해양수산청 효율성 비교 분석에 관한 연구)

  • Lee, Nam-Kyu;Kim, Si-Hwa
    • Journal of Navigation and Port Research
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    • v.32 no.1
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    • pp.73-80
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    • 2008
  • The purpose of this paper is to measure the productive efficiency and competitive strength of Regional Maritime Affairs and Fisheries Office using the DEA. Using EMS(Efficiency Measurement System) which is LP solver, quantifies in one way or another a "distance" to the efficient frontier of the technology. An input oriented measure quantifies the input reduction which is necessary to become efficient holding the output constant. Symmetrically, an output oriented measure quantifies the necessary to become efficient holding the inputs constant. A non-oriented measure quantifies necessary improvements when both inputs and outputs can be improved simultaneously. According to the analysis result of the DEA method, inefficient Regional Maritime Affairs and Fisheries Office should recommend benchmarking reference Regional Maritime Affairs and Fisheries Office in order to enhance the productive efficiency of port administration and a public institution. Besides data on productive efficiency serves as a tool for policy-makers at all levels of activity and is essential for improving the efficiency with which the various systems operate.

Basic and Mechanical Properties by Film Type to Minimize the Sound Pressure Level of PTFE Laminated Vapor-permeable Water-repellent Fabrics (PTFE(Polytetrafluoroethylene) 라미네이팅 투습발수직물의 총음압 최소화를 위한 필름 타입 별 기본 특성과 역학 특성)

  • Lee, Kyu-Lin;Lee, Jee-Hyun;Jin, Eun-Jung;Yang, Youn-Jung;Cho, Gil-Soo
    • The Korean Fashion and Textile Research Journal
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    • v.14 no.4
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    • pp.641-647
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    • 2012
  • This study investigates the sound properties of fabric frictional sound (SPL, ${\Delta}L$, ${\Delta}f$) according to the film type of PTFE laminated vapor-permeable water-repellent fabrics in order to understand the relationship between SPL and the basic properties of fabrics such as layer, yarn type, and thickness of fiber. This study accesses their mechanical properties and determines how to control them to minimize SPL. Eight PTFE laminated water-repellent fabrics, composed of four different film types (A, B, C, D) and with two different fabrics, were used as test specimens. Frictional sounds generated at 1.21m/s were recorded by using a fabric sound generator and SPLs were analyzed through Fast Fourier Transformation (FFT). The mechanical properties of fabrics were measured by KES-FB. The SPL value was lowest at 74.4dB in film type A and highest as 85.5dB in type D. Based on ANOVA and post-hoc test, specimens were classified into less Loud Group (A, B) and Loud Group (C, D). It was shown that SPL was lower when 2 layer (instead of 3 layer), filament yarn than staple, and thin fiber than thick were used. In Group I, shearing properties (G, 2HG5), geometrical roughness (SMD), compressional properties (LC, RC) and weight (W) showed high correlation with SPL however, elongation (EM) and shear stiffness (G) did with SPL in Group II.

The Cost-effective Eletronic ballast for Metal halide Lamp using DSP (DSP를 이용한 비용 절감형 메탈할라이드 램프용 전자식 안정기)

  • Han, Sang-Soo
    • Journal of the Institute of Electronics and Information Engineers
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    • v.54 no.4
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    • pp.108-112
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    • 2017
  • High-intensity-discharge lamps are widely utilized in outdoor and indoor lighting circumstances that need high luminance. In lighting applications for MHD lamps, the size of the lamp ballast circuit is an important factor and should be as small as possible. The electronic ballast for MHD lamps is superior to the electromagnetic(EM) ballast in that it saves energy, and has smaller volume and lighter weight. In this paper, highly efficient cost-effective and small sized electronic ballast for Metal Halide Lamp with high power factor using Digital Signal Processor are proposed. The proposed electronic ballast for MHD lamps combines a boost PFC converter with a half-bridge inverter, the algorithms of the power factor correction and ballast control were implemented using the TI's TMS320LF2406 CPU. Experimental results validate the ballast is also useful and reasonably suggested.

Influence of Interference of the Non-chewing Side on Electromyographic Activity of Masticatory Muscles (비저작측 교합간섭이 저작근 활성도에 미치는 영향)

  • Hun-Bong Kwan;Hong-So Yang
    • Journal of Oral Medicine and Pain
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    • v.13 no.1
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    • pp.23-33
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    • 1988
  • The purpose of this study was to standardized and classify the coordination pattern among the chewing side and non-chewing side masseter and anterior muscles, in terms of EMG values on lateral excursion, clenching, and mastication in presence of the non-chewing side. In this study, 25 subjects were selected for experiment of lateral excursion, clenching and mastication and EMG value of the masseter and anterior temporal muscle on both sides were recored 2 times respectively. The bioelectric processor model EM2(Myo-tonic research, INC. U.S.A.) with the surface electrodes were used to record the EMG activity during all experimental procedures. The results were as follows : 1. During lateral excursion on intereference of non-chewing side, the EMG values of the temporal muscle were significantly more prominent than those of the temporal muscle on the non-chewing side. The EMG values of non-chewing side were significantly more prominent than those of chewing side on the both side masseter muscle and those of chewing side were significantly more prominent than those of non-chewing side on the both side temporal muscle. 2. During clenching on the occlusal interferance, the EMG values of non-chewing side masseter muscle were most prominent. 3. During mastication on the occlusal interferance, the EMG values of the chewing side temporal muscle were most prominent and those of non-chewing side temporal muscle were the lowest. 4. The EMG values of temporal muscle of non-chewing side on interferance were significantly more prominent than those of canine guidance during lateral excursion. 5. During clenching on the occlusal interferance, the EMG values of the masseter and the temporal muscles of the non-chewing side were significantly more prominent than canine guidance, but those of chewing side temporal muscle on canine guidance were significantly more prominent than those of interferance. 6. During mastication on canine guidance, the EMG Values of the temporal muscle on the chewing side, the masseter muscle on the chewing side and the temporal muscle on the non-chewing side were more prominent than those of interferance, but temporal muscle of non-chewing side was not different between canine guidance and occlusal interferance on non-chewing side.

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Electromagnatic Effect Analysis inside Electrically Large Structures Using Topological Modeling and PWB Method (위상학적 모델링과 PWB Method를 이용한 대형 구조물 내부의 전자파 영향 해석)

  • Lee, Jae-Min;Jung, In-Hwan;Lee, Jae-Wook;Lee, Young-Seung;Kwon, Jong-Hwa
    • The Journal of Korean Institute of Electromagnetic Engineering and Science
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    • v.27 no.3
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    • pp.284-290
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    • 2016
  • As the recently advanced scientific developments result in high lever of the usability and the needs for the electrical equipment and devices in various situations, the safety technologies protecting malfunction and electrical critical damages including soft and hardware from the unexpectedly radiated electromagnetic interferences are required gradually. In addition, the numerical analysis for the miniaturized electrical components and equipments as well as the conventional electrical devices installed inside the electrically large enclosures and structures requires the memory requirement and time consumption too big to be handled in a realistic situation, which will result in a limitation in solving the complete set of maxwell's equations. In this paper, PWB method based on statistical theory and topological modeling with appropriate zoning concepts are introduced for the EM analysis of an electrically large complex structures.