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Survey of Operation and Status of the Human Research Protection Program (HRPP) in Korea (2019) (임상시험 및 대상자보호프로그램의 운영과 현황에 대한 설문조사 연구(2019))

  • Maeng, Chi Hoon;Lee, Sun Ju;Cho, Sung Ran;Kim, Jin Seok;Rha, Sun Young;Kim, Yong Jin;Chung, Jong Woo;Kim, Seung Min
    • The Journal of KAIRB
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    • v.2 no.2
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    • pp.37-48
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    • 2020
  • Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

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Regeneration Processes of Nutrients in the Polar Front Area of the last Sea IV. Chlorophyll a Distribution, New Production and the Vertical Diffusion of Nitrate (동해 극전선역의 영양염류 순환과정 IV. Clorophyll a 분포, 신생산 및 질산염의 수직확산)

  • MOON Chang-Ho;YANG Sung-Ryull;YANG Han-Soeb;CHO Hyun-Jin;LEE Seung-Yong;KIM Seok-Yun
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.31 no.2
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    • pp.259-266
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    • 1998
  • A study on the biological and chemical characteristics in the middle last Sea of Korea was carried out at 31 stations in October $11\~18$, 1995 on board the R/V Tam-Yang. The chlorophyll a concentration, new and regenerated production, and the vertical diffusion of nitrate from the thermocline structure were investigated. From the vertical distribution of chlorophyll a, subsurface maxima were observed near the thermorline at most stations including the frontal zone, except at the southern stations where the maximum chloropyll a concentration occurred at the surface, The nanophytoplankton was the most dominant fraction comprising $83.5\%$ of total phytoplankton cell numbers, but netphytoplankton were common at the southern stations where the dominant species were Rhizosolenia sp. Nitrogenous new production and regenerated productions were measured using the stable isotope $^{15}N$ nitrate and ammonia uptake method. The vertically integrated nitrogen production varied between 8.470 and $72.945\;mg\;N\;m^{-2}\;d^{-1}$. The f-ratio, which is the traction of new production from primary production, waried between 0.03 and 0.72, indicating that $3\%$ to $72\%$ of primary production was supported by the input of nutrients from below the euphotic zone and the rest are supported by ammonia recycled within the euphotic layer. This range of f-ratio encompasses from extremely oligotrophic to eutrophic area characteristics. The differences in productivity and f-ratio among stations were related to frontal structure and the bottom topography. The values were high near the frontal zone and low outside of it, and the station near Ulleng Island showed the highest f-ratio. Vertical diffusion coefficients were calculated from both the water column stability (Kz-1) of King and Devol's equation (1979) and new nitrogen requirement (Kz-2). The values of Kz-2 ($0.11\~0.55\;cm^2/s$) were relatively low compared to the values reported previously.

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A Research on the Creative Behavior of Children's Plays in Sangsang Children's Park, Seoul City (서울시 상상어린이공원의 창의 놀이 행태 분석 연구)

  • Kang, Young-Jai;Kim, Yo-Seob;Cho, Se-Hwan
    • Journal of the Korean Institute of Landscape Architecture
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    • v.40 no.5
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    • pp.109-118
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    • 2012
  • The study is aimed to suggest a preliminary data on the improvement of children's recreational facility to enhance children's creativity at Sangsang Children Park Project(SCPP) in Seoul Metropolitan City being the case study. The book review, especially the field observation was implemented by the video recording methods for analyzing the children's play behavior with regard to the six sites of the SCPP that was constructed in March 2008 until May 2010. Because of the research, the first 21 patterns of the creative activities were shown. Second, the prime using rates of facilities were the combination of play facilities among other play facilities like swings, slides, trembling horse etc. However, more children's creative behaviors occurred on independent play facilities like swing, trembling horse, etc. than at combination play facilities. Third, children's creative behaviors diversely occurred at a moving or fluid facility like a swing, trembling horse and a spatial facility like sand field more than a fixed facility like combination play facility. Fourth, children's creative behavior could be divided and evaluated by five categories and elements of fluency: the flexibility, the creativity, the elaborateness, and the imagination. Nevertheless, it was assumed that the creative elements of the five categories were mixed together with each other instead of showing an individual characteristic. Fifth, based on this analysis, the research reached out to the conclusion that the combination play facility of imaginary children's park would be designed together with more fluid and spatial facilities to improve the children's creativity. Finally, It was proposed that the play facilities of imaginary children's park like drawing wall or board, spatial play facilities and handicraft facilities etc. would be introduced to improve sorts of creativeness on elaborateness and imagination shown less than the fluency, flexibility, and originality.

Design and Fabrication for the Development of Auto Pattern Maker (자동취형기 개발을 위한 설계 및 제작)

  • Lee, Young-Il;Kim, Jung-Hee;Park, Jee-Hyun
    • Journal of Korean Ophthalmic Optics Society
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    • v.18 no.3
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    • pp.231-239
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    • 2013
  • Purpose: To design and fabricate the auto pattern maker for the development. Methods: we got the necessary data, needed in design, by using CAD. Based on the these data, we fabricated the trial product for the development of the auto pattern maker. Results: The auto pattern maker were composed with combinations of many elements; pattern making assembly, control panel, frame attachment and prober unit. The pattern making assembly was comprised of the cutter, the pattern holder, pattern remover and silence cover which could minimize the sound during the cutting process. The control panel was designed to be connected and operated with the main printed circuit board. The prober could get the eye shape data by scanning of 1.8 degrees around the groove of the frame through the encoding data according to the address. After starting, scanning was carried out in two passes, i.e. one right-handed and one left-handed. Communication connector could send the eye shape data from auto pattern maker to outer system with the RS232C transmission system. By using the one-way analysis of variance, we got the error rate of cut pattern size for ${\Phi}22mm$, ${\Phi}55mm$ and ${\Phi}62mm$. Because F-value was 0.510 and p-value was 0.601, no statistically significant differences were found. Also, the mean cutting error of the auto pattern maker was 0.0274 mm. Conclusions: we could succeed in making the trial product by applying it to the development of the auto pattern maker. The role of this auto pattern maker is to find a exact required size of lens to fit the frame by measuring the frame. The acquired data are transferred to outer system for grinding and finishing with patternless process. Also, the trial product can produce pattern to fit the frame. Therefore, it was confidently expected that the optometrists could handily produce pattern to fit the frame with this trial product and dispense the ophthalmic lens because of its efficiency and convenience compared to the past.

An analysis of the Domestic Interior Materials as the Ecological Design Aspects (친환경측면에서 본 국내 실내건축자재의 현황 조사 및 분석)

  • Chun Jin-Hie;Kim Jung-Ah
    • Archives of design research
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    • v.19 no.4 s.66
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    • pp.133-144
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    • 2006
  • According to the latest report by the Customer Protection Board, those who moved into newly constructed buildings are complaining about unidentified pains, asking for more careful selection of constructive materials for prevention of such potential problems. It is internationally recognized today that ecological materials can serve a significant factor for users' health, environmental protection and better industrial competitiveness. This study examined eco-design aspects of each interior material through web site search, in order to help customers learn about and capitalize on eco materials in a proper manner. As a result, 1. It turned out that the domestic industry are giving an impetus to releasing new eco items focusing on lower VOCs emission or addition of functional components as part of the marketing strategy. However, it is recommended that company understand significance of life cycle, and produce eco-concept materials. 2. The reliable standard for choosing the domestic material is EL, HB, GR marks. It is desirable to enhance recycling technologies and expand the sustainable consumption. customer class, since many recycled items are not developed. 3. The sourcing is a vulnerable part in terms of the concept of being environment-friendly material. Therefore, many manufacturers should design the easy knock-down products and produce the good items using recycled materials instead of new raw materials. Also solutions for making the energy from burning material should be studied. 4. The guidebook or manual with correct information about eco-materials is required to promote production and consumption with sustainable concept. 5. Many manufacturers are emphasizing ecological materials for customers, but some of them intended to disrupt customers' proper selection by promoting even unverified items to be environment-friendly.

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Dose Characteristics of Total-Skin Electron-Beam Irradiation with Six-Dual Electron Fields (Six-Dual 전자선 조사면에 의한 전신 피부 조사의 선량 특성)

  • Choi, Tae-Jin;Kim, Jin-Hee;Kim, Ok-Bae
    • Radiation Oncology Journal
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    • v.16 no.3
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    • pp.337-345
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    • 1998
  • Purpose : To obtain the uniform dose at limited depth to entire surface of the body, the dose characteristics of degraded electron beam of the large target-skin distance and the dose distribution of the six-dual electron fields were investigated Materials and Method : The experimental dose distributions included the depth dose curve, spatial dose and attenuated electron beam were determined with 300 cm of target-skin distance (TSD) and full collimator size (35*35 $cm^2$ on TSD 100 cm) in 4 MeV electron beam energy. Actual collimated field size of 105 cm * 105 cm at the distance of 300 cm could include entire hemibody. A patient was standing on step board with hands up and holding the pole to stabilize his/her positions for the six-dual fields technique. As a scatter-degrader, 0.5 cm of acrylic plate was inserted at 20 cm from the body surface on the electron beam path to induce ray scattering and to increase the skin dose. Results : The full width at half maximum(FWHM) of dose profile was 130 cm in large field of 105*105 $cm^2$ The width of $100\pm10\%$ of the resultant dose from two adjacent fields which were separated at 25 cm from field edge for obtaining the dose unifomity was extended to 186 cm. The depth of maximum dose lies at 5 mm and the 80$\%$ depth dose lies between 7 and 8 mm for the degraded electron beam by using the 0.5 cm thickness of acrylic absorber. Total skin electron beam irradiation (TSEBI) was carried out using the six dual fields has been developed at Stanford University. The dose distribution in TSEBI showed relatively uniform around the flat region of skin except the protruding and deeply curvatured portion of the body, which showed excess of dose at the former and less dose at the latter. Conclusion : The percent depth dose, profile curves and superimposed dose distribution were investigated using the degraded electron beam through the beam absorber. The dose distribution obtained by experiments of TSEBI showed within$\pm10\%$ difference except the protruding area of skin which needs a shield and deeply curvatured region of skin which needs boosting dose.

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A Study on the Characteristic of Ship`s Magnetic Distribution of M. S. KAYA by the Varies of Artificial Local Disturbance (인위적 지방자기 변동에 의한 가야호의 선체자기 분포특성에 관한 연구)

  • 조현정
    • Journal of the Korean Society of Fisheries and Ocean Technology
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    • v.34 no.2
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    • pp.144-158
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    • 1998
  • In order to study basic information on the developed electro-magnetic compass, experiments were carried out on board M. S. KAYA at the pier of Dong Kuk Steel Mill in Pusan and the Korean southern sea using a three-axis magnetic sensor from Jan. 21, 1995 to Feb. 14, 1996. The obtained results were as follows : 1. The amount of old metal on the pier was about 27,290tons~57,440tons with an average of 40,560tons, the artificial local disturbance at the pier was min. 27.1$\mu$T, max. 66.5$\mu$T, ave. 433$\mu$T for the horizontal component and min. -27.0$\mu$T, max. 45.1$\mu$T, ave. 3.7$\mu$T for the vertical component. Its direction of horizontal component was 305$^{\circ}$ with the ship's head up bearing at 225$^{\circ}$. 2. The ship's magnetic distribution on the starboard side on berthing at the pier was 17.4$\mu$T for the horizontal component and -6.2$\mu$T for the vertical component. On the ship's port side, it was 19.8$\mu$T for the horizontal component and 4.1$\mu$T for the vertical component. On the ship's starboard side at sea, the ship's magnetic distribution was 19.2$\mu$T for the horizontal component and 3.2$\mu$T for the vertical component. On the ship's port side, the readings were 22.0$\mu$T for the horizontal component and -1.8$\mu$T for the vertical component. The directions of these readings were nearly starboard side. 3. On the pier, the secular change of the artificial local disturbance decreased 8.3$\mu$T from 61.0$\mu$T to 52.7$\mu$T for the horizontal component and decreased 7.1$\mu$T from 8.9$\mu$T M 1.8$\mu$T for the vertical component. On the starboard side from its berth, the ship, s magnetic distribution increased 2.6$\mu$T from 14.8$\mu$T to 17.4$\mu$T for the horizontal component and increased -0.1$\mu$T from -6.1$\mu$T to -6.2$\mu$T for the vertical component. On the ship's port side from its berth, it increased 7.1$\mu$T from 12.7$\mu$T to 19.8$\mu$T for the horizontal component and increased 10.2$\mu$T from -6.1$\mu$T to 4.1$\mu$T for the vertical component. 4. While at sea, on the ship's starboard side, the Secular change of the ship's magnetic distribution increased 3.9$\mu$T from 15.3$\mu$T to 19.2$\mu$T for the horizontal component and increased 2.0$\mu$T from -5.2$\mu$T to -3.2$\mu$T for the vertical component. On the port side, the changes increased 11.4$\mu$T from 10.6$\mu$T to 22.0$\mu$T for the horizontal component and increased 4.9$\mu$T from -6.7$\mu$T to -1.8$\mu$T for the vertical component. Upon berthing at the pier, the deviation of the secular change increased westerly 1 degree W~ 2.5$^{\circ}$ W from 3.5$^{\circ}$ W~ 5$^{\circ}$ W M 6W with the ship's head up bearing at 225$^{\circ}$. While at sea, these increased westerly 2$^{\circ}$ ~ 3$^{\circ}$ from the Northeast to the South and increased easterly 1$^{\circ}$ ~ 8$^{\circ}$ from the Southwest to the North. 5. While at port, within 1 mile between the ship and berth of the pier, as we approached the pier, the westerly deviation increased and when we departed the pier easterly deviation increased. When approaching the pier, the deviation was smaller than the deviation when the ship was departing from the pier. When approaching the bearing at 225$^{\circ}$ with the ship's head up bearing, the varies of deviation was smaller than the varies when the ship's head up bearing was departing from it.

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Evaluation of Shear Bond Strength and Adhesive Bond Durability of Mixed Species Structural Glued Laminated Timber (이수종 구조용집성재의 전단접착력 및 접착내구성 평가)

  • Shim, Sangro;Yeo, Hwanmyeong;Shim, Kugbo
    • Journal of the Korean Wood Science and Technology
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    • v.33 no.1 s.129
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    • pp.87-96
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    • 2005
  • This study was carried out to evaluate the shear bond strength and adhesive bond durability of structural glued laminated timber (glulam) manufactured with mixed species lumber of Korean red pine, Korean pine and Japanese larch, using resorcinol adhesive and water-based polymeric-isocyanate adhesive (WPI). Each board used as a glulam lamina was graded by visual inspection. The visual lumber grade of the all species was very low due to the large size and number of knots and the steep slope of grain. In view of the results, appropriate pruning, sawing and drying processes might be needed to produce high grade lamina lumber with small knot size and drying defect free. Shear bond strength of every tested glulam specimen ranged between 7.9 and $9.9N/mm^2$, and much higher than the Korean Standard (KS) for glulam shear bond strength, $7.1N/mm^2$. There was not much shear bond strength difference between wood/resorcinol and wood/WPI. The resorcinol adhesive bond durability exceeded KS requirements. However, delamination on the end-grain surfaces of WPI glulam submerged in both room temperature and boiling water severely occurred, and its durability did not meet KS requirements. Further investigations may be required, and special care should be taken, to ensure long service life of WPI glulam used for exterior application. Results of this study are expected to be useful for improvement of mechanical properties and structural performance of mixed species glulam.

Studies on the Appraisal of Stumpage Value in the Forest Land - With Respect to Kyung-Ju Area - (산원지(山元地) 임목평가(林木平価)에 관(関)한 연구(研究) - 경주지방(慶州地方)을 중심(中心)으로 -)

  • Rha, Sang Soo;Park, Tai Sik
    • Journal of Korean Society of Forest Science
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    • v.52 no.1
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    • pp.37-49
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    • 1981
  • The purpose of the study is to find out the objective method of valuation on the forest stands through the analysis of logging costs that is positively related to timber production. The two forest (Amgog, Whangryoung), located nereby, but forest type, logging and skidding conditions being slightly different, were slected to carry out the study. The objective timber stumpage value were determined by investigating the appropriate timber production costs and profits of logging operations. The main result obtained in this study are as follows: 1. The rate of logging cost in consisting of timber market price is 13.15% in the area of Amgog logging place and 19.48% in Whangryoung. 2. The rate of the other production cost excluding logging cost is 15.36% in the area of Amgog logging place and 28.85% in Whangryoung. 3. The total rate of timber production cost in consisting of the market price is more than 28.51% in the area of Amgog logging place and 48.33% in Whangryoung, 4. Though the productivity of forest land is affected by the selection of tree species, tending, treatments and effective management of forest land, the more important problem is improvement of logging condition. 5. The rate of production cost in timber price is so high that we should endeavore to improve the productivity of labour and its quality, and minimize the difference of piece work per day in accordance to the various site condition. 6. Although the profit of forest industry is related to the period of recapturing investment, it is more closely related to the working condition, risk of investment and continuous change of social investment interest. 7. If the right variables which are related to the timber market, are objectively obtained, the stumpage value of mature forests can be objectively caculated by applying straight line discounting method or compound discounting method in caculating the stump to market price.

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Biomass and distribution of Antarctic Krill, Euphausia superba, in the Northern part of the South Shetland Islands, Antarctic Ocean (남극 남쉐틀란드 군도 북부 해역의 크릴 분포 및 자원량)

  • KANG Donhyug;HWANG Doojin;KIM Suam
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.32 no.6
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    • pp.737-747
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    • 1999
  • To estimate biomass and distribution of the Antarctic krill (Euphausia superba), hydroacoustic survey was conducted on board of R/V Yuzhmorgeologiya, which was chartered by Korea Antarctic Research Program (KARP) group from 18 to 21 December 1998, in the northern part of the South Shetland Islands, Antarctic Ocean, The scientific echo sounder (towing body type) used was EK- 500 (SIMRAD, Norway) with echo integrator (BI-500) at 38 kHz frequency and recorded mean backscattering cross-section coefficient (SA) per 1 $mile^2$ of sea surface. Also, Bongo net sampling was carried out to determine the size of krill and CTD (Conductivity, Temperature and Depth) casting to understand physical structure. Water column was divided into 5 layers (22$\~$65 m, 65$\~$115 m, l15$\~$65 m, 165$\~$215 m and 215$\~$315 m) to know vertical distribution of krill biomass. The standard length of krill collected was between 30 mm and 51 mm, and adult krill had single mode (41 mm). Maximum horizontal length of krill patch was about 35 nautical mile and vertical thickness was about 275 m. High density of krill was appeared in frontal area between Circumpolar Deep Water (>$1^{\circ}C$) and very low temperature water mass (< $-0.5^{\circ}C$) that originate from Weddell Sea. According to the results calculated using target strength equation, krill density was totally higher in continental slope and open water areas than in coastal area. In the study area, krill seems to distribute in depth; density was low at first layer ($\={\rho}=17.0\;g/m^2$) and higher at fourth layer ($\={\rho}=40.19\;g/m^2$). The estimated krill biomass at total survey area and water column was about 2.77 million metric ion ($\={\rho}=151.0\;g/m^2$) and coefficient of valiance ( CV, $\%$) was 19.92. The proportions and biomass of krill biomass at each layer were as follows; layer 1 ($11.3\%$, 0.31 million metric ton, CV=16.24), layer 2 ($13.3\%$, 0.37 million metric ton, CV=34.91), layer 3 ($23.7\%$, 0.66 million metric ton, CV=41.5), layer 4 ($26.6\%$, 0.74 million metric ton, CV=27.84) and layer 5 ($25\%$, 0.69 million metric ton, CV= 26.83).

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