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항균제 임상시험 Guideline

  • 우준희
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 1994.11a
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    • pp.27-30
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    • 1994
  • 잠재적으로 항감염 약제로 사용될 가능성이 있는 약제들의 초기 연구과정에서 주된 관심사는 이들이 미생물(세균, 바이러스, 기타 기생충)에 대한 작용들이 있는가 하는 점이다. 이러한 작용들이 실험적으로 충분히 연구가 된 후에야 실험동물에서 그 효과를 연구한다. 항 바이러스 제제의 경우에는 세포배양을 통한 연구가 그 약제의 독성과 효용성을 나타내는데 필수적인 것이 된다. 여러 종류의 동물을 이용한 생체실험에서 약제의 일반적인 흡수와 배설, 분포 등에 관한 정보와 약제 자체와 동물 내에서의 대사적 변화에 대한 정보가 제공된다. 여러 가지 미생물로 감염을 시킨 적합한 동물과 여러 가지 용량으로 치료하는 실험을 통하여 약제의 항 감염 능력이 알려지게 된다. 동물에서의 생체실험과 실험관내에서 실험을 하고 나서야 사람에서의 연구가 이루어지게 된다. 소위 전임상시험에서 대표적 병원성 미생물에 대한 생물학적효과, 약리학적 효과와 독성 그리고 동물실험모델에서의 가능한 효과가 결정된 후에 임상시험에 들어가기 마련이다. 항균제의 임상시험에는 각각의 감염질환에 대한 진단 및 치료기준을 반영하는 것이 기본이다. 새로운 항균제의 임상시험에서는 안전성과 효과가 반드시 밝혀져야 한다. 1상에서는 인체에서의 약리효과, 안전성이 주목적이며, 2상과 3상은 겹쳐지는 점도 있으나 하나 또는 그 이상의 적응증에 대한 항균제의 효과와 단기간의 부작용은 2상에서 관찰하여야하며, 다수의 환자에서 제안된 적응질환의 무작위임상시험과 다수에서의 안전성도 3상에서 관찰하여야 한다. 4상에서는 이상에서의 자료로 시판된 후에도 계속해서 감시하는 것으로 지속적으로 안전성을 관찰하는 것이다. 이러한 기본사항외에도 소아, 임산부, 고령자등에서의 임상시험도 넓은 의미에서 포함되어야 할 것이며 또한 질적인 면에서 조절하는 Quality Assurance도 중요하다.양상은 세 용량군 간 차이가 없었으나, 시험기에서 발열의 발현율이 낮았으며, 발열일 수와 항생제 사용일 수가 짧았다. 결론: 골수억제 조절 효과는 용량에 따른 혈액소견에 미치는 영향, 부작용, 감염의 빈도, 감염발생에 따른 항생제 사용기간 등을 고려하여 그 임상 유효성 평가시, 제 3상 시험에 사용할 권장량 (recommended dose) 은 250 ug/$m^2$/d $\times$ 10d 으로 관찰되었다.5주에 부검한 랫드의 간에서 c-myc 종양단백의 발현은 모든 처리군들이 대조군에 비하여 높게 발현되는. 것이 관찰되었으나 시험개시후 26주에 부검한 랫드의 간에서 c-myc 종양단백의 발현은 대조군에 비하여 차이가 거의 없었다. 따라서 랫드에서 화학적으로 유도한 간암발생 과정에서 NK 세포활성이 현저하게 억제되는 것으로 생각되며, c-myc 종양단백의 발현은 시험개시후 15주에 그 발현이 확실한 것으로 사료되어 진다.에 영향을 주는 성분이 있음을 제시하였다.1과 항우울약들의 항혈소판작용은 PKC-기질인 41-43 kD와 20 kD의 인산화를 억제함에 기인되는 것으로 사료된다.다. 것으로 사료된다.다.바와 같이 MCl에서 작은 Dv 값을 갖는데, 이것은 CdCl$_{4}$$^{2-}$ 착이온을 형성하거나 ZnCl$_{4}$$^{2-}$ , ZnCl$_{3}$$^{-}$같은 이온과 MgCl$^{+}$, MgCl$_{2}$같은 이온종을 형성하기 때문인것 같다. 한편 어떠한 용리액에서던지 NH$_{4}$$^{+}$의 경우 Dv값이 제일 작았다. 바. 본 연구의 목적중의 하나인 인체유

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A Static and Dynamic Design Technique of Smart Contract based on Block Chain (블록체인 기반의 스마트 컨트랙트 정적/동적 설계 기법)

  • Kim, Chul-Jin
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.6
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    • pp.110-119
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    • 2018
  • Blockchain technology has been highly evaluated for its contracts (contracts for sale, real estate contracts) because of its excellent security, including integrity and non-repudiation. In a blockchain, these contract services can be developed using a technology called a smart contract, and several blockchain platforms provide a programming language for developing smart contracts. Bitcoin and Ethereum, typical blockchain platforms, provide the Bitcoin Scripts and Solidity languages. Using these programming languages, we can develop the smart contract, a digital contract that can be processed dynamically. Smart contracts are being developed in a variety of areas, but studies of designs based on a blockchain are insufficient. In this paper, we propose a meta-model and a static/dynamic design method based on Unified Modeling Language (UML) for smart contracts based on Ethereum. We propose a method for static design attributes and functions of smart contracts, and propose a technique for designing structures among contracts. Dynamic design proposes a technique for designing deployment, function calls, and synchronization among smart contracts, accounts, and blocks within a blockchain. Experiments verify the validity of the design method by applying the static/dynamic design method through real estate contracts.

An Analysis of First Flush Phenomenon of Non-point Source Pollution during Rainfall-Runoff Events from Impervious Area (불투수성 지역의 강우유출수에 대한 비점오염물질의 초기유출현상 분석)

  • Ahn, Tae-Ung;Bum, Bong-Su;Kim, Tae-Hoon;Choi, I-Song;Oh, Jong-Min
    • Journal of Korean Society of Environmental Engineers
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    • v.35 no.9
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    • pp.643-653
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    • 2013
  • In this study, trend analysis was performed by various runoff analysis method of Non-point Pollution Source(NPS) at the impervious area. The characteristics of rainfall at impervious area appeared to be influenced by rainfall strength and it appeared that first flush phenomenon occurs often if rainfall strength acts largely. It is judged that the measure is required to be prepared against that now that concentration difference of non-point pollution source appeared to be big by precedent number of days of no rainfall. As the result of calculating Decrease Rate (DR) by first flush of non-point pollution source, it is judged that it is important to prepare the measure against the pollutants about initial rain and it is necessary to calculate the capacity of non-point pollution source processing facilities regarding that now that the non-point pollution source integrated at impervious area showed the characteristics that are flowed out in high concentration by initial rain in case of non-rainfall considering the characteristics of non-point pollution source at impervious area. When taking 50% of non-point pollution source as the standard for decrease rate that was evaluated previously, it appeared as 15~60 min in case of TSS and it appeared as 30~90 min in case of organic compound, but the characteristic whose decrease rate is below 50% also appeared even till rainfall-runoff ends. Based on that, it is judged that it could be used as the reference when designing the structural BMPs facilities later.

Analysis of the GPS Error Effect through Simulation (시뮬레이션을 통한 GPS 오차의 영향 분석)

  • Jeon, Jae-Han;Kwon, Jay-Hyoun;Lee, Ji-Sun
    • Journal of the Korean Society of Surveying, Geodesy, Photogrammetry and Cartography
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    • v.26 no.4
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    • pp.397-405
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    • 2008
  • The position accuracy is primarily dependent on the satellite position and signal delay caused by several elements. To know the effect of the delay on the estimated positions, we simulated GPS raw data (RINEX) with GPS errors using Bernese ver5.0. GPS errors used in this paper are Ionospheric delay, Cycle slip, Troposphere, DOP and Random error. If the baseline is short, the position error according to TEC is not large, since the ionospheric delay effect can be removed by ion-free combination. However, if the baseline is long, 3 dimensional position error up to 10cm is occurred. The 3D position error of coordinates with cycle slip is hardly ever changed up to 60% of cycle slip. Because the simulated cycle slips are equally distributed on satellites, the positioning was not seriously affected by the cycle slip. Also, if percentage of cycle slip is 60%, three dimensional error is sharply increased over 1m. The position error is calculated by using the observation data (2 hours) which was selected by DOP less than 3. And its accuracy is more improved about $3{\sim}4cm$.

Expanding Health Education Plan For Improving Public Health (국민건강증진을 위한 보건교육확대방안에 관한 연구)

  • Yun, Gi-Seon;Park, Chung-Yeol
    • The Journal of the Korea Contents Association
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    • v.15 no.3
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    • pp.303-317
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    • 2015
  • Although the public health centers have been initiating health education recently, it is not extending as expected and the participation of the program is low. The reason is that the office workers have few opportunities to receive health education since there are few public health centers in relation to the population. Much time is required for travel and attendance of the classes. In order to solve this problem, the aim is to increase participation in health education, improve the overall public health awareness, expand the number of health education locations to reduce medical expenses, vitalize the lifelong educational health programs, and improve the national health insurance. In order to research about the health education expansion plan for public health improvement, a study focused on men and women above age 20 who need health education. The research sample was selected through random sampling that targeted people who participated in the health programs or the health education. The period of this survey was from September 1st to September 30th, 2014. A total of 509 participants completed the survey data for the actual analysis to propose the health education expansion plan for the public health improvement.

Effect of Succinylation on Functional Properties of Leaf Protein Concentrates (Succinylation이 엽농축단백질(葉濃縮蛋白質)의 기능성(機能性)에 미치는 영향(影響))

  • Cho, Yeong Su;Kim, Jong Kyu
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.12 no.3
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    • pp.251-258
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    • 1983
  • This experiment was carried out to investigate the capability of production of artificial milk for leaf protein concentrate (LPC). Chloroplastic protein and cytoplasmic protein were extracted from leaves of Dystaenia takeshimana Nakai and LPC was extracted from leaves of Italian ryegrass to increase the functional properties of LPC as a level of milk casein. One gram of chloroplastic protein and cytoplasmic protein and 1g of LPC were succinylated by addition of succinic anhydride 0.1, 0.25, and 1g respectively. Their functional properties were investigated in this experiment. The results obtained were summarized as follows: 1. The non-succinylated LPC showed a higher value in bulk density than the chloroplastic protein, the cytoplasmic protein and LPC succinylated by addition of succinic anhydride 0.1, 0.25, and 1g respectively. Nevertheless, succinylation had an enhancing effect as indicated by the rises as the degrees of succinylation was increased. 2. Although solubility of non-succinylated LPC was lower than that of milk casein, succinylation caused an effective increase in the solubility of the protein and LPC. 3. Water absorption and fat absorption of succinylated LPC were twice to eight times higher than those of milk casein. Fat absorption was not influenced to the extent by succinylation as the water absorption. Excessive succinylation resulted in the decrease of both water absorption and fat absorption. 4. Emulsifying activity and emulsion stability were increased in proportion to the succinylated degree of LPC. More than 10% increase in the amount of succinic anhydride resulted in an apparent increase in emulsifying activity and emulsion stability. Besides, the succinylated LPC showed more excellent functional properties in emulsifying activity and emulsion stability than milk.

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PREVENTIVE EFFECT OF ADHESIVE TAPE SUPPLEMENTED WITH NaF ON ENAMEL EROSION IN VITRO (불소함유 접착테잎의 법랑질 침식 예방효과)

  • Lee, Sang-Ho;Lee, Nan-Young;Lee, In-Hwa
    • Journal of the korean academy of Pediatric Dentistry
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    • v.37 no.1
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    • pp.82-90
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    • 2010
  • This study examined the effect of adhesive tape supplemented with sodium fluoride on the prevention of dental erosion in vitro. Sound bovine tooth samples were selected and divided randomly into the following 4 groups according to the material treatments: group 1, APF gel; group 2, fluoride varnish; and groups 3 and 4, fluoride tape supplemented with 5% NaF in either a methyl cellulose or poly vinyl acetate carrier, respectively. All specimens were submitted to alternate cycles of acid exposure in a cola beverage (pH 4.3) and artificial saliva for $6\;{\times}\;5\;min/day$ over a 5 day period. The micro-hardness was recorded each day and the lesion depth was measured after 5 days. The micro-hardness of the experimental sides of groups 2, 3 and 4 were significantly higher than that of their control sides and the experimental side of group 1 during the experimental period (p<0.05) except on the 5th day. The enamel surfaces of treatment groups 2, 3 and 4 showed significantly higher resistance to mineral loss in terms of the erosion depth (p<0.05) than group 1 and their control sides. There was no statistically significant difference among group 2, 3 and 4, indicating that the fluoride varnish and tapes produce similar results. Fluoride adhesive tapes are effective in reducing the progression of erosion and can be recommended for young patients who are more susceptible to dental erosion.

Comparative Studies of Perceiving Korean Monosyllabic Digit Words under Different Speech Compression Schemes (음성압축 방식의 변화가 한국어 단음절 숫자 인지기능에 미치는 영향의 비교 연구)

  • Lim, Dukhwan;Won, Yookyung
    • The Journal of the Acoustical Society of Korea
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    • v.32 no.3
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    • pp.262-268
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    • 2013
  • The performances of speech compression schemes appeared to be dependent on the response profiles to compressed stimuli and the features of individual languages to some extent. Although these response profiles were critical in comparing various compression outcomes, the related data were limited in number for Korean monosyllabic words. From the previous study, data from PNT (Preserving No Trait) compression was selected as a base set for comparison. In this study, the outcomes from PPT (Preserving Pitch Trait) and PTT (Preserving Time Trait) were analyzed under the same condition. Then, the properties of these three widely used representative compression schemes were quantitatively compared in normal hearing adults (N=20) for controlled Korean quintet digit sets (0 through 9). Results showed that PPT compression scheme exhibited the best perceptual performances for the Korean quintet digit sets in the final outcomes (PPT>PTT>PNT). The compression ratios of 50% performances were estimated as about 20%, 42%, and 44% for PPT, PTT, and PNT, respectively. The data indicated the influences of the salient psychoacoustic features of the three representative compressions on perceiving Korean monosyllabic digit words. This controlled procedure with monosyllabic quintet sets can evaluate efficiency and effectiveness of other compression schemes and may also contribute to diagnosing auditory processing disorders and fitting special hearing aids with compression issues.

Development for Penetrative Performance Improving Agent to In Prevent Deterioration of Concrete Structures (콘크리트 구조물의 내구성능 저하를 방지하는 침투형 성능개선제 개발)

  • Ryu Gum-Sung;Koh Kyoung-Taek;Kim Sung-Wook;Kim Do-Gyeum
    • Journal of the Korea Concrete Institute
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    • v.17 no.4 s.88
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    • pp.489-498
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    • 2005
  • Recently, the deterioration of concrete structures have been increased by the damage from salt, carbonization, freezing & thawing and the others. Therefore, the measures for the deterioration of concretes have been taken. Among them, it has been often used that surface treatment which cut off the deterioration factors of durability by protecting the surface of concrete. The water proof and repair materials for concrete mainly use organic materials such as epoxy, these materials excel in intial bonding force and resistance to chemical agents. But they cause difference in the modulus of elasticity and the rate of shrinkage and expansion of concrete, and thus result in such problems as scaling and spatting in the progress of time. Therefore in this study it develop the performance Improving agent of concrete surface that can block a deterioration cause such as $CO_2$ gas, chloride ion and water from the outside and enhance waterproofing ability by reinforcing the concrete surface when applying it to concrete structures.

Design of a Policy-based Security Mechanism for the Secure Grid Applications (안전한 그리드 응용을 위한 정책기반의 보안 기능 설계)

  • Cho, Young-Bok;You, Mi-Kyung;Lee, Sang-Ho
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.12 no.2
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    • pp.901-908
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    • 2011
  • For the available grid environmental realization, the resource supply PC must have to provide an appropriate security function of their operation environments. SKY@HOME is a kind of the grid computing environments. If this has not supervised by administrator handling smoothly, it is inherently vulnerable state to the security level of the grid environments, because the resource supply PC is not update a security function without delay. It is also have the troublesome problems which have to install of an additional security program for support the appropriate security. This paper proposes an integration security model on the policy-based that provides an update each level according to the situation of the resource supply PC for improving its problems as a security aspect of the SKY@HOME. This model analyzes the security state of the resource supply PC respectively, and then the result is available to provide an appropriate security of the resource supply PC using an integration security model. The proposed model is not need additionally to buy and install the software, because it is provided the security management server oriented service. It is also able to set up the suit security function of a characteristic of the each resource supply PC. As a result, this paper clearly show the participation of resource supply PC improved about 20%.