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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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Effect of Continuous use of Inorganic Fertilizer on the Soil Organisms and Food Chain (무기질비료의 장기연용이 토양생물 및 먹이연쇄에 미치는 영향)

  • Eo, Jinu;Park, Kee-Choon;Park, Jin-Myeon;Kim, Myung-Hyun;Choi, Soon-Kun;Bang, Hea-Seon
    • Korean Journal of Environmental Agriculture
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    • v.35 no.1
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    • pp.39-45
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    • 2016
  • BACKGROUND: This study aimed to evaluate the combined effects of three components (NPK) of chemical fertilizers with basal application of compost on soil organisms.METHODS AND RESULTS: The soil was treated with five treatments continuously for 15 years: control, PK, NK, NP and NPK. The application of N increased plant growth or biomass, and enhanced organic matter content in the soils. Levels of microbial phospholipid fatty acids (PLFAs) in the soils did not show marked differences among the soils treated with different treatments. However, the principal component analysis showed the changes in the structure of the microbial community in the soil, depending on treatments added. Nitrogen application caused a decrease of pH and an increase of EC in the soils, and these environmental stresses appeared to offset the promoting effect of increased organic matter content on microbial abundance. The abundance of bacterivorous nematodes was the highest in the soils after treating NPK; however, the abundance of fungivorous nematodes was unaffected. There was no significant correlation between the abundances of microbial groups and their feeders. Organic matter content was significantly correlated with the abundance of nematodes in the soils.CONCLUSION: Our results showed that chemical fertilizers affect the soil food chains through both biotic and abiotic factors, and a trophic cascade in the soils may not occur in response to long-term fertilization.

Trend and Affecting Factors of Ecological Deficit in North Korea (북한의 생태적자 추이 및 영향요인 분석)

  • Yeo, Min Ju;Kim, Yong Pyo
    • Journal of Environmental Impact Assessment
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    • v.27 no.1
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    • pp.56-72
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    • 2018
  • North Korea has been in ecologically deficit state since 1966, despite of lack of energy and food resources. Trends of the Biocapacity (BC), the Ecological Footprint (EF), and the Ecological Deficit (ED) of North Korea were shown and five factors influencing on the Overshoot Rate (OSR) which is the ratio of the BC and the EF in North Korea was analyzed in this study. The five factors consist of two factors affecting to the EF and three factors affecting to the BC in North Korea. Two of the five factors are affecting to the EF those are population, the EF per capita (EFPC) which indicates the individual environmental consumption intensity, and three are affecting to the BC those are the land area, the yield factor, and the value multiplying the equivalence factor and the intertemporal yield factor. The EF has contributed more than the BC to the OSR. From 1966 to mid-1990s, the EFPC was the most contributing factor at about 60%, and after mid-1990s, population at about 40~60%. Contribution ratio of land area and the yield factor have increased after mid-1990s up to 15% and 18%, respectively. The BC of cropland which has decreased due to a decrease in productivity. In order to reduce the ED of North Korea, improvement of productivity of cropland and restoration of forest. Forest area has decreased significantly since 1990 in NK. And ways to solve the food shortage problem which influences on decrease of both productivity of cropland and forest area.

A Study of LNG Bunkering Demands on Ulsan Port for Demonstration of Floating LNG Bunkering Terminal (해상부유식 LNG 벙커링 터미널 시범사업을 위한 울산항 LNG 벙커링 수요전망에 관한 연구)

  • Kim, Ki-Dong;Choi, Kyoung-Shik;Oh, Yong-sam;Cho, Sang-Hoon;Kim, Sung-Hun;Shin, Dong-Geun;Jung, Dong-ho;Kim, Hack-Eun;Shin, Dong-hyun
    • Journal of the Korean Institute of Gas
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    • v.21 no.1
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    • pp.65-71
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    • 2017
  • LNG is being spotlighted as a clean marine fuel because of recent trend in reinforcement of marine environmental regulation. In this paper, demand prospect of LNG bunkering for Ulsan port is carried out to analgize the possibility of commercialization of floating LNG bunkering terminal. Environmental analysis for LNG bunkering and LNG bunkering trends of competitive ports in the world are considered to draw out the prospection of LNG bunkering demand in Ulsan. As a result, car carrie and oil carrier were expected to have more possibility in switching to LNG fuelled ship. The LNG bunkering demand in Ulsan. As a result, car carrier and oil carrier were expected to have more possibility in switching to LNG fuelled ship. The LNG bunkering demand in Ulsan port was expected to be about from 650,000 ton to 900,000 ton in 2030 and Ulsan port is prospected to be a good port for FLBT business in th future.

A Study on the Effects of N , $P_2O_5$ and $K_2O$ Application on the Vegetation and Dry Matter Yield in the Mixed Sward of Oechardrass and Crabgrass ( Digitaria sanguinalis [L.] Scop.) (Orchargrass와 바랭이 ( Digitaria sanguinalis [ L. ] Scop ) 혼생초지에 있어서 질소 , 인산 및 가리시용이 식생 및 건물수량에 미치는 영향)

  • 김창주
    • Journal of The Korean Society of Grassland and Forage Science
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    • v.15 no.2
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    • pp.93-100
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    • 1995
  • This experiment was carried out to investigate how to effect the application of nitrogen, phosphate and potassium on the vegetation and dry matter yield in the mixed sward of orchardgrass and crabgrass (Digitaria sanguinalis [L.] Scop.). The experimental sward wa5 consisted of eight plots of non-application, P, K, PK, N. NK, NP and NPK. These plots were sown with seeds mixture of orchardgrass 17.5 kglha and crabgrass 17.5 kg/ ha on 22 April 1975 in the forage experimental field of Kangwon National University, Chunchon, Korea, and were cut four times from 6 July to 18 November 1975. The results obtained were summarized as follows: 1. In orchardgrass density measured after summering, the plot of nitrogen applied without phosphate marked only 3 1.0% of the plot of nitrogen applied with phosphate while in crabgrass density measured at that time the plot of nitrogen applied without phosphate marked as high as 112.5% of the plot of nitrogen applied with phosphate. 2. Application of phosphate and potassium improved wintering record of orchardgrass. In orchardgrass density measured after wintering, the plot of nitrogen applied without phosphate marked only 9.7% of the plot of nitrogen applied with phosphate, and the plot of NP applied without K marked 63.6% of the plot of NP applied with K. 3. In surface coverage of orchardgrass, in midsummer any plot applied with nitrogen regardless of accompanying with or not with phosphate wa5 0%, but in autumn the plot of nitrogen applied with phosphate was 56-58% and the plot of nitrogen applied without phosphate was 5%. While after wintering the plot of nitrogen applied with phosphate was 28-37% though the plot of nitrogen applied without phosphate was only 0.3-0.6%; the application of phosphate improved summering and wintering record of orchardgrass. 4. Application of phosphate demonstrated remarkable effect on increasing dry matter yield in orchardgrass. In year total yield of orchardgrass, the plot of nitrogen applied without phosphate marked as low as 11.3% of the plot of nitrogen applied with phosphate, but in crabgrass the plot of nitrogen applied without phosphate was almost equal to the plot of nitrogen applied with phosphate showing 97.5% of this plot. 5. Application of potassium was not effective on increasing dry matter yield of orchardgrass but its application was effective on increasing dry matter yield of crabgrass. In dry matter yield of orchardgrass significant difference was not found between NP plot and NPK plot, but in dry matter yield of crabgrass NPK plot recorded significantly higher yield compared with NP plot (p<0.05). 6. In botanical composition of the plot of nitrogen applied with phosphate, crabgrass recorded 46.5-50.5% in early summer (July) but in midsummer (August) it dominated the plot recording 85.6-91.2%. 7. In botanical composition based on the year total yield, in the plot of nitrogen applied with phosphate orchardgrass marked 21.7-26.2% and crabgrass recorded 73.8-78.370, but in the plot of nitrogen applied without phosphate orchardgrass marked only 3.5% being overwhelmingly dominated by crabgrass which recorded 96.5%. 8. Application of nitrogen not accompanied with phosphate strengthened competitive power of the crabgrass unilaterally, making orchardgrass be oppressed fatally by the crabgrass.

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The Comparison Consideration on Experimental Articles about Melanoma Published in Journals of Korean Medicine (국내 한의학계에 보고된 흑색종 관련 실험적 연구들의 비교 고찰)

  • Kwon, Kang;Kim, Nam-Kwen;Kim, Sung-Young;Lee, Dong-Jin;Kim, Chul-Yun;Seo, Hyung-Sik
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.28 no.3
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    • pp.30-47
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    • 2015
  • Objective : Melanoma is a very critical and devastating disease. Although many people have depended on surgical operation in melanoma treatment, they have placed importance on non-invasive methods constantly. So we planned to establish a research methodology by analysing existing articles containing conservative melanoma treatments in Journals of Korean Medicine published in Korea.Methods : Using search words of anti-cancer, B16, cancer, lung metastasis, melanoma, metastasis, S-100, SK-MEL, tumor, tyrosinase, we collected 26 articles by searching internet portal sites as following;Using search words of anti-cancer, B16, cancer, lung metastasis, melanoma, metastasis, S-100, SK-MEL, tumor, tyrosinase, we collected 26 articles by searching internet portal sites as followinghttp://oasis.kiom.re.kr,http://www.koreantk.com,http://www.riss.kr,http://www.dbpia.co.kr,http://www.ndsl.kr,http://kiss.kstudy.com,http://www.naver.com,http://www.google.com.Result : The number of articles is 26 and in the year of 2003, 2004 is ranked the highest number in publication. The journal of acupuncture & moxibustion society ranked the highest(30.8%). 2 and 4 authors ranked the highest(26.9%) in number of authors. T-test ranked the highest(58.1%) in statistics methods. P.O. med indicated in 11 articles and Pharmacopuncture in 15 articles. B16 murine melanoma cell was indicated in 25 articles by cancer-induced methods. In measurement, T cell activity was indicated in 14 articles, NK activity in 4 articles, IL-2 in 6 articles, apoptosis in 1 article, lung metastasis in 14 articles.Conclusion : Considering overall results, it is necessary to diversify cancer-induced methods and measurement methods in experimental melanoma research.

Response of Weed Population to Long-term Fertilizer Application (장기간 시비조건에 (施肥條件) 따른 잡초발생(雜草發生) 변화(變化)에 관한 (硏究))

  • Ku, Y.C.;Oh, Y.J.;Lee, J.H.
    • Korean Journal of Weed Science
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    • v.3 no.1
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    • pp.50-56
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    • 1983
  • A study was conducted to evaluate the weed population as affected by repeated application of fertilizers for 15 years (nonfertilized, PK, NK, NPK, NPK+Compost, NPK+Straw and NPK+lime). Alopecurus aequalis authority did not grow at all without P application and lime reduced the population of A. aequalis. Total number of weeds were the largest at 5-10cm soil layer and increased by application of compost and straw. Monochoria vaginalis dominated in NPK+compost and NP plot. Scirpus hotarui dominated in NPK+straw. Both Eleocharis kuroguwai and Potamogeton distinctus dominated in nonfertilized plot. Numbers of M. vaginalis and S. hotarui were larger low pH 6 while that of E. kuroguwai and P. distinctus at pH 6 to pH 7. Incidence of M. vaginalis and S. hotorui was great at pH's lower than 6, while E. kuroguwai and P. distinctus favored pH's ranging from 6 to 7.

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The Study on Acute and Subacute Toxicity and Anti-Cancer Effects of cultivated wild ginseng Herbal acupuncture (정맥주입용(靜脈注入用) 산양산삼(山養山蔘) 증류약침(蒸溜藥鍼)의 급성(急性).아급성(亞急性) 독성실험(毒性實驗) 및 Sarcoma-180 항암효과(抗癌效果)에 관(關)한 실험적(實驗的) 연구(硏究))

  • Kwon, Ki-Rok;Cho, A-La;Lee, Sun-Gu
    • Journal of Pharmacopuncture
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    • v.6 no.2
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    • pp.7-27
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    • 2003
  • Objective : The purpose of this study was to investigate acute and subacute toxicity and sarcoma-180 anti-cancer effects of herbal acupuncture with cultivated wild ginseng (distilled) in mice and rats. Method : Balb/c mice were injected intravenous with cultivated wild ginseng herbal acupuncture for $LD_{50}$ and acute toxicity test. Sprague-Dawley rats were injected intravenous with cultivated wild ginseng herbal acupuncture for subacute toxicity test. The cultivated wild ginseng herbal-acupuncture was injected at the tail vein of mice. Results : 1. In acute $LD_{50}$ toxicity test, there was no mortality thus unable to attain the value. 2. Examining the toxic response in the acute toxicity test, there was no sign of toxication. 3. In acute toxic test, running biochemical serum test couldn't yield any differences between the control and experiment groups. 4. In subacute toxicity test, there was no sign of toxication in the experimental groups and didn't show any changes in weight compared to the normal group. 5. In subacute toxicity test, biochemical serum test showed significant increase of Total albumin, Albumin, and Glucose in the experimental group I compared with the control group. Significant decrease of GOT, ALP, GPT, and Triglyceride were shown. In experiment group II, only Glucose showed significant increase compared with the control group. 6. Measuring survival rate for anti-cancer effects of Sarcoma-180 cancer cell line, all the experimental groups showed significant increase in survival rate. 7. Measuring NK cell activity rate, no significant difference was shown throughout the groups. 8. Measuring Interleukin-2 productivity rate, all the experimental groups didn't show significant difference. 9. For manifestation of cytokine mRNA, significant decrease of interleukin-10 was witnessed in the experimental group compared to the control group. Conclusion : According to the results, we can conclude cultivated wild ginseng herbal acupuncture caused negligible toxicity, and had anti-tumor effects in mice.

Design and Application of the Problem Based Learning Model for Environment Teaching Unit (환경단원 수업을 위한 문제중심학습 설계 및 적용)

  • Park, Soo-Kyong
    • Journal of the Korean earth science society
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    • v.25 no.4
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    • pp.205-213
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    • 2004
  • The purpose of this study was to design the coaching strategies for the problem based learning and examine 'the problem situation' to analyze the process of learning as it applies to the students' perception on problem based learning. The steps of this model were as follows: 1) presentation of the problem situation 2) confrontation of the problem 3) know/ need to know 4) definition of the problem statement 5) collection and sharing of information 6)generation of possible solutions 7) assessment of the best fit of solutions 8) presentation of the solution. Problem-based learning steps and coaching strategies were designed and implemented to 2nd grade high school students for the environment teaching unit. The results demonstrated that group discussion in the know/need to know step was most helpful for students to review what they know and generate solutions. At first students tend to state problems widely but through repeated group discussions they gradually clarified the problems. In the students' personal reflection notes and perception questionnaire of problem-based learning, many students especially showed difficulties in defining the problem statement. In contrast they participated actively in the learning process and express their opinions enthusiastically. Therefore, this study suggests that developing problem situation based on real context is of great importance for implementing a problem based teaming model continuously.

Brittle crack arrest design for shipbuilding welding structural with thick steel plate (고강도 극후물재 용접부 취성균열 전파 정지 기술 개발에 관한 연구)

  • An, Gyu-Baek;Ryu, Kang-Mook;Lee, Jong-Sub;Park, Tae-Dong;Shin, Yong-Taek;Han, Ki-Hyung;Jeong, Sang-Hoon;Kang, Sung-Ku
    • Proceedings of the KWS Conference
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    • 2009.11a
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    • pp.92-92
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    • 2009
  • 조선업을 포함한 다양한 산업 분야에서 후판 강재의 수요량 증가와 함께 사용 범위 또한 폭넓게 되고 있다. 특히, 선박의 수송효율의 극대화를 위하여 컨테이너선의 대형화가 급속하게 진행되고 있으며, 2009년 현재1,300TEU 이상의 초대형 컨테이너선이 건조되고 이다. 이처럼 용접구조물의 초대형화에 따른 사용강재 또한 고강도 극후물화 되고 있다. 현재 선박에 적용중인 고강도 강재는 EH47 강재로 YP 460MPa 급의 강재가 Hatch Coamming부에 적용중에 있으며, 강재의 두께 또한 70mm 이상이다. 이러한 고강도 극후물재의 강구조물에 적용에 따른 선급협회에서는 용접부에서의 취성균열 전파에 의한 취성파괴의 위험성이 있으므로 강재의 두께를 제한하고 더욱 엄격한 파괴인성값을 요구하고 있다. 일본선급협회(NK)를 중심으로 취성균열의 정지를 위한 모재의 요구 성능등에 관한 연구들이 진행되고 있다. 이 연구의 대부분의 전제 조건은 선박의 블럭과 블럭의 조립시에 용접부가 직선형이 아닌 계단형(Butt shift)를 하는 것으로 하고 있으므로, 국내의 조선건조 공법의 현실과는 거리감이 있다. 본 연구에서는 국내 조선사에서 수행중인 직선 이음부에 대한 시공 공법에서 취성균열이 발생하여 진전 되더라도 균열을 정지 시킬 수 있는 기술에 관한 연구를 수행하였다. 균열의 진전은 대부부의 연속면에서는 정지를 시키지 못하고 직진 전파 하여서 파괴에 도달하게 된다. 따라서 뭔가의 불연속적인 면을 임의로 생성하여야 균열을 정지 시킬 수 있다. 본 연구에서는 이러한 균열의 정지 방법으로 형상적인 측면과 재료적인 측면에서 검토를 수행하였다. 형상적인 측면에서는 균열을 정지 시키고자 하는 위치에 불연속적인 면을 만들기 위하여 일정 크기의 hole을 만들어서 균열을 정지시켰으며, 재료적인 측면에서는 고인성의 용접재료를 사용하여서 취성균열이 진행하는 경로에 인성을 높은 재료를 적용하여 불연속적인 면의 생성과 함께 인성을 높여서 균열을 정지 시키는 기술을 개발하였다. 이러한 기술의 개발을 통하여 취성균열의 전파에 의한 파괴를 방지 할 수 있으며, 용접구조물의 안전성 확보를 가능하게 하였다.

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