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Preparation of guidance documents item by item for one-step evaluation and approval for Medical Devices (의료기기 일괄허가 및 기술문서 심사를 위한 품목별 길라잡이 개발)

  • Kim, Yong-Woo;Shin, Chae-Min;Bang, Ji-Young;Yi, Jung-Yeon;Oh, Hyeon-Joo;Bae, Woo-Jin;Choi, Jin-Man;Lim, Kyung-Mi;Oh, Heon-Jin;Kim, Mi-Young;Hur, Chan-Hoi;Kim, Hyung-Bum;Choi, Min-Yong;Kwak, Ji-Young;Kim, Su-Yeon;Hwang, Sang-Yeon;Youn, Hae-Suk;Hong, Hye-Kyeong;Ahn, So-Young;Lee, Chang-Hyung;Jeong, Jin-Baek;Koo, Ja-Jung;Kang, Se-Gu;Jung, Jae-Hoon;Lim, Kyoung-Taek;Lim, Chang-Keun;Kim, Min-Su;Lee, Seong-Hyi;Lee, Jae-Keun;Park, Ki-Jung
    • Journal of Biomedical Engineering Research
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    • v.31 no.4
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    • pp.280-284
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    • 2010
  • Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

Effect of Bleeding Time on Meat Quality and Shelf-Life of Broiler (방혈 시간이 닭고기의 품질 및 저장성에 미치는 영향)

  • Chae H. S.;Ahn C. N.;Yoo Y. M.;Ham J. S.;Jeong S. G.;Lee J. M.;Choi Y. I.
    • Korean Journal of Poultry Science
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    • v.32 no.3
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    • pp.187-193
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    • 2005
  • This study was carried out to investigate the effect of the bleeding times(30sec., 90sec., 150sec.) at slaughtering process on meat quality and storage properties of broiler. The redness$(a^{\ast}\;value)$ of skin, wing, leg muscle decreased at high bleeding time(150sec.). However, there was no significant difference in breast muscle. WHC(water holding capacity) of breast muscle decreased from $63.64\%$ at low bleeding time(30sec.) to $61.06\%$ at high bleeding time. TBARS(thiobarbituric acid-reactive substance) values were 0.18 mgMA/kg at the low bleeding time, 0.16 mgMA/kg at the middle bleeding time(90sec.) and 0.21mgMA/kg high bleeding time on 3 days of storage. Total aerobic plate counts(TPC) were $6.25logCFU/cm^2$ at the low bleeding time, $6.25logCFU/cm^2$ at the middle bleeding time and $6.53logCFU/cm^2$ at the high bleeding time. The TPC was increased as the bleeding time increased. In conclusion, meat color of chicken were acceptable when the carcasses were slaughtered at the high bleeding time.

Effect of the Anthracnose Resistant Transgenic Chili Pepper on the Arthropod Communities in a Confined Field (야외 격리 포장에서 유전자 변형 탄저병 저항성 PepEST 고추가 절지동물 군집에 미치는 영향)

  • Yi, Hoon-Bok;Kwon, Min-Chul;Park, Ji-Eun;Kim, Chang-Gi;Park, Kee-Woong;Lee, Bum-Kyu;Kim, Hwan-Mook
    • Korean Journal of Environmental Biology
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    • v.25 no.4
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    • pp.326-335
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    • 2007
  • This study was conducted to assess the environmental risks of anthracnose resistant transgenic chili peppers with the PepEST gene on non-target organisms in the agroecosystem environments during the chili pepper growing seasons in 2006. We quantitatively collected arthropods assemblages living on leaves and flowers of chili peppers on June 20, July 25, and August 25 by using an insect vacuum collector to compare the patterns of arthropod community structures between non-transgenic chili peppers (nTR, WT512) and anthracnose resistant transgenic chili peppers (TR, line 68). We found the seasonal difference with the highest species richness and Shannon's diversity in July's sampling among the growing seasons (P<0.05) and each sampling season showed the different arthropod community composition. We also found there was no statistical difference between the two types of crops, nTR and TR, at each sampling time (P>0.05). The significance level of arthropod community showed that there were lots of seasonal difference of functional groups as well as taxa but only the herbivore group in the functional groups was significantly different for the types of plants (P<0.05). So, we further examined the herbivore groups to find any potential damage and identified the possibility of herbivorous damage from some herbivores, grasshoppers, aphids and thrips. Although we couldn't find any adverse effects from the environmental risk assessment between the arthropod community structures on two types of plants from our results, we should keep working for the environmental risk assessment because of the herbivorous potential risk possibility.

Particle Size Analysis of Lead Aerosol with the use of 2730ppm Lead Nebulizing Solution for Inhalation Toxicology Study (흡입독성 연구를 위한 2730ppm 납 네뷸라이징 용액에서 발생된 에어로졸의 입경분석)

  • Jeung Jae Yeal;Kang Sung Ho;Kim Sam Tae;Lee Eun Kyoung;Song Young Sun;Lee Ki Nam
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.17 no.2
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    • pp.518-524
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    • 2003
  • Ultrasonic nebulizer with the application of new engineering methodology and the design of electronic circuit was made for lead inhalation toxicology study and 2730ppm lead nebulizing solution was used to generate lead aerosol. After modification of source and inlet temperatures, the results of particle size analysis for lead aerosol were as following. The highest particle counting for source temperature 20℃ was 39933.66 in inlet temperature 100℃ and particle diameter 0.75tLm. The highest particle counting for source temperature 50℃ was 39992.71 in inlet temperature 250℃ and particle diameter 0.75μm. The highest particle counting for source temperature 70℃ was 37569.55 in inlet temperature 50℃ and particle diameter 0.75μm. The ranges of geometric mean diameter(GMD) were 0.754-0.784μm for source temperature 2℃, 0.758-0.852μm for source temperature 50℃, and 0.869-1.060μm for source temperature 70℃. The smallest GMD was 0.754μm in source temperature 20℃ and inlet temperature 20℃, and the largest GMD was 1.060μm in source temperature 70℃ and inlet temperature 250℃. The ranges of geometric standard deviation(GSD) were 1.730-1.782 for source temperature 20℃, 1.734-1.894 for source temperature 50℃, and 1.921-2.148 for source temperature 70℃. The lowest GSD was 1.730 in source temperature 20℃ and inlet temperature 20℃, and the highest GSD was 2.148 in source temperature 70℃ and inlet temperature 250℃. Lead aerosol generated in this study was polydisperse. The ranges of mass median diameter(MMD) were 1.856-2.133μm for source temperature 20℃, 1.877-2.894μm for source temperature 50℃, and 3.120-6.109μm for source temperature 70℃. The smallest MMD was 1.856μm in source temperature 20℃ and inlet temperature 20℃, and the largest MMD was 6.109μm in source temperature 70℃ and inlet temperature 250℃. Slight increases for GMD, GSD, and MMD values were observed with same source temperature and increase of inlet temperature. MMD for inhalation toxicology testing in EPA guidance is less than 4μm. In this study, source temperature 20℃ and 50℃ with inlet temperature from 20℃ to 250℃ were conformed to the EPA guidance, but inlet temperature 20℃ and 50℃ for source temperature 70℃ were conformed EPA guidance. MMD for inhalation toxicology testing in OECD and EU is less than 3μm. In this study, source temperature 20℃ and 50℃ with inlet temperature from 20℃ to 250℃ were conformed to the EPA guidance, but none for source temperature 70℃.

The Decision of Voiding Cystourethrography in Children with Urinary Tract Infection (소아 요로감염에서 배뇨성 방광 요도 조영술의 결정)

  • Kim, Dong-Woon;Choi, Eung-Sang;Lim, In-Seok
    • Childhood Kidney Diseases
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    • v.11 no.2
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    • pp.203-211
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    • 2007
  • Purpose : We attempted to compare the independent factors such as age, sex, C-reactive protein(CRP), and white blood cell count(WBC) in children with radiologic studies and assess the necessity of performing voiding cystourethrography(VCUG). Method : 98 children who have been diagnosed their first time febrile urinary tract infection from Janurary 2002 to Januray 2005 were enrolled. In all patient, the duration of fever which occurred before and after treatment was recorded, and CRP, WBC, $^{99m}Tc$-2,3-dimercaptosuccinic acid($^{99m}Tc$-DMSA) renal scans, renal ultrasound and VCUG were analyzed. Results : Of the 98 children diagnosed with urinary tract infection(UTI), 52 were male and 46 were female. 18 had abnormalities in VCUG, 17 had abnormalities in kidney ultrasound, and 20 had partial defects or diffuse uptake decrease in $^{99m}Tc$-DMSA renal scans. There were no significant relationship between incidence of radiologic abnormalities and age. The risk of renal scar was significantly higher in children who had a longer febrile period before treatment than in those with shorter period. Both CRP and WBC were significantly elevated in children with the radiological abnormalities. A positive of $^{99m}Tc$-DMSA renal scans and renal ultrasound were highly associated with vesicoureteral reflux(VUR). Conclusion : If there are abnormalities in the kidney ultrasound and $^{99m}Tc$-DMSA renal scan of a child with initial UTI, a VCUG is recommended. Even in cases without abnormal findings in $^{99m}Tc$-DMSA renal scan and renal ultrasound, clinical data such as CRP and WBC should be assessed, and VCUG should be Performed for the undetected VUR.

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The Significance of Acetylcholine Receptor Autoantibody Test (아세틸콜린 수용체 항체(Acetylcholine receptor autoantibody) 검사의 의의)

  • Yoo, Soh-Yeon;Lim, Soo-Yeon;Pack, Song-Ran;Seo, Mi-Hye;Moon, Hyung-Ho;You, Sun-Hee
    • The Korean Journal of Nuclear Medicine Technology
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    • v.15 no.1
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    • pp.113-116
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    • 2011
  • Purpose: Acetylcholine receptor antibodies cause acetylcholine receptor loss, which is responsible for failure of the neuromuscular junction in the acetylcholine receptor autoantibody. The disease characterized by muscle weakness and fatigue, myasthenia gravis(MG) occurs when the body inappropriately produces antibodies against acetylcholine receptors, and thus inhibits proper acetylcholine signal transmission. And this reason, the measurement of acetylcholine receptor antibodies can be of considerable value in disease diagnosis. Methods: From 2010. August to September, we tested orderd AchRAb 19 samples to get the results. 1. Pipette $5{\mu}{\ell}$ undiluted patient sera and kit control and add 125I AChR $50{\mu}{\ell}$ and incubate at R.T for 2 hours. 2. Pipette $50{\mu}{\ell}$ of anti-human IgG into each tube, and incubate at $2{\sim}8^{\circ}C$ for 2 hours. 3. Pipette $25{\mu}{\ell}$ precipitation enhancer into each tube and add 1mL washing solution into all tubes. 4. Centrifuge each tube for 20minutes at $2{\sim}8^{\circ}C$ at 1500g. 5. Aspirate or decant the supernatant. 6. Pipette 1 mL washing solution into all tubes and resuspend the pellet and repeat centrifugation. 7. Aspirate or decant the supernatant and count all tubes on a gamma counter. Results: Cut off value is 0.2 nmol/L and the results taken below 0.2 nmol/L are negative, the results above that identified as being positive values. We assayed the 19 patients samples and got 7 positive results. Of which, 6 patients were diagnosed as MG.(85.7%). Conclusions: Acetylcholine Receptor autoantibody test is intended for use by persons only for the quantitative determination of it in human serum. Even if measurement of the antibodies is not a routine test, it can be of considerable value in disease diagnosis.

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The Origination and Changes of Street Fashion (스트리트 패션의 발생과 변천)

  • Jung, Kyong-Hee;Yoo, Tai-Soon
    • Journal of Fashion Business
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    • v.1 no.1
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    • pp.71-83
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    • 1997
  • The purpose of this study is to analyze the present fashion phenomenon by considering the types of street fashion, the center of avant-grade modern fashion, that shows the origination background and special feature concretely. The times was defined through the 1980's from World War II that street style originated, so the range of study was the 1990's when the street style was influenced by that of the past and was revived. The ways of study were to analyze the records of ideology, art and music connected with the street style from World War II to the present when it has risen. The summary of result is as follows. (1) In the 1940's, Zooties was the jet of desire suppressed by African-Americans that couldn't receive favors socially and economically and Hipsters pursued reformative bebop that made up of soft Jazz. In the 1950's, Modernists were running after Cool Jazz to the minimum. In the 1970's, Funk appered in the sexual desire and erotic strength, and was surfaced from Negro Getto. In the 1980's B-boys & Flygirls showed the street style by the scribble art of slum in the New York. As mentioned above, In the 1990's, Acid Jazz influenced by the Jazz of Negro has been the fashion added to the tradition of musical form that come from eclecticism of Jazz tended Neo-Jazz. (2) In the 1940's, Western style dreamed the country life because of rapid urbanization. In the 1950's, Beat obtained the feeling of liberation from the dissolute life and activity. In the 1960's, Psychedelics showed the freedom affected by the Pop-art and Op-art, and Hippies pursued the true individuality as 'love & peace' life style and the return to nature. In the 1990's, Grunge look influenced by the above has been fashion that shows the practical use of second-hand clothing or patchwork contrary to elitism. (3) In the 1940's, Caribbean style appered in the typical textile color with the center of West Indies. In the 1960's, Rude boys showed the magnificence and difficulty of Jamaica, and Rastafarians had a tendency to come back to the ancient civilization of America. In the 1970's, Two-tone was the simple clothing for harmonizing among human races. In the 1990's, Jamaica look influenced by the above has been the Lege fashion introduced to a high fashion, appearing in the special bright color, applique, unique hair style, and so on. (4) In the 1950's, Sufers pursued natural rhythm, getting out of everything. In the 1970' s, Skaters enjoyed the speed on the paved road. In the 1980's, Casuals emphasized the spirit of cooperation of young-things. In the 1990's, Casual look Influenced by the above has been the fashion that forms the activity, function and strong spirit of cooperation by pursuing comfortable life and sports in the tension of life and variety of modern society. (5) It was hard for Bikers to adjust themselves in society after the war. In the 1950's, Coffee bar cowboys were the reckless running boys in the leather jacket. In the 1960's, Rockers created the group originality as disobedient outsiders and Greasers imitated Rolling Stones. In the 1980's, Punks resisted the viewpoint of the old generation in offensive fashion. In the 1990's, Cyberpunk influenced by the above has pursued the classless structure, electronic music and metallic clothing that forebodes gloomily as the computer generation of ultra-modern science times. Accordingly, in understanding a complex modern fashion phenomenon, it was analyzed that the street styles of the past, from World War II to the 1980's, were reflected in that of the 1990's dividing into the five types in a word, namely Acid Jazz, Grunge look, Jamaica look, Casual look and Cyberpunk.

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Geochemistry of the Kwanaksan alkali feldspar granite: A-type granite\ulcorner (관악산 알칼리 장석 화강암의 지구화학 : A-형 화강암\ulcorner)

  • S-T.Kwon;K.B. Shin;H.K. Park;S.A. Mertzman
    • The Journal of the Petrological Society of Korea
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    • v.4 no.1
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    • pp.31-48
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    • 1995
  • The Jurassic Kwanaksan stock, so far known to be composed of biotite granite only, has the mineral assemblage of quartz+K-feldspar+plagioclase+biotite${\pm}$gernet. The lithology of the stock is classified as alkali feldspar granite by their mode and plagioclase compositions (An<5). Subsolvus feldspars, rather early crystallization of biotite, and shallow emplacement depth estimated from Q-Ab-Or diagram suggest hydrous nature of the magma, which contrasts with anhydrous A-type like geochemistry described below. Major and trace element compositions of the Kwanaksan stock are distinct from those of the adjacent Seoul batholith, suggesting a genetic difference between the two, The Kwanaksan stock shows geochemical characteristics similar to A-type granite in contrast to most other Mesozoic granites in Korea, in that it has high $SiO_2$(73~78wt%), $Na_2O+K_2O$, Ga(27~47 ppm). Nb(22~40 ppm), Y(48~95 ppm), Fe/Mg and Ga/Al, and low CaO(<0.51 wt%). Ba (8~75 ppm) and Sr(2~23 ppm). However, it has lower Zr and LREE and higher Rb(384~796 ppm) than typical A-type granite. LREE-depleted rare earth element pattern with strong negative Eu anomaly of previous studies is reinterpreted as representing source magma characteristics. The residual material during partial melting is not compatible with pyroxenes, amphibole or garnet, while significant amount of plagioclase is required. Similarity of geochemistry of the Kwanaksan stock to A-type granite suggests the origin of the stock has a chose relationship with that of A-type granite. These observations lead us to propose that the Kwanaksan stock was formed by partial melting of felsic source rock.

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Establishment of Herbicide Screening Methods for Reed (Phragmites communis Trin.) Control - I. Propagation of Reed (갈대(Reed, Phragmites communis Trin.)의 방제를 위한 제초제 스크리닝방법의 확립 - I. 갈대의 육묘)

  • Hwang, I.T.;Choi, J.S.;Lee, H.J.;Hong, K.S.;Cho, K.Y.
    • Korean Journal of Weed Science
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    • v.16 no.1
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    • pp.21-27
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    • 1996
  • This experiment was conducted to find out an effective propagation method for reed(Phragmites communis Trin.), ensuring a continuous herbicide screening for reed control. Reed propagation methods were compared under a greenhouse condition using tour different materials; seeds, rhizomes, depressed stolons of P. japonica Steud., and stem cuttings. Although reed seeds were easy to harvest and store, their germination rate(${\leq}$5%) was very low and seedling growth from the seeds was slow. Rhizomes were difficult to harvest and their harvest time was limited from November to March. Furthermore, reed propagation using rhizomes had problems of a relatively low germination rate(46%), no uniformity in size and shape, individual differences at the early stage of growth, and difficulties in material storage. Rate of reed growth from rhizomes was higher in commercial soil mix(Boo Nong soil) than in sand or in sand+upland soil(1:1). Depressed stolons of P. japonica had a moderate germination rate(65%) and were relatively easy to harvest. However, their harvest time was limited only from August to September. Propagation method using stem cuttings had several advantages over the above methods using other materials. Reed plants could uniformly be propagated from the stem cuttings with a relatively high germination rate(75%). Stem cuttings of central nodes showed a higher germination rate compared to those of upper or lower nodes. Stem cuttings from the field should be used immediately after harvest, since their germination rate decreased rapidly when they were stored under a wet- or a dry-refrigerated condition. Furthermore, the germination of stem cuttings tended to decrease when they were collected from the field after August. This indicates that there is a limitation of harvest time for stem cuttings. However, a year-round propagation of reed using stem cuttings is possible if parent plants are grown in a greenhouse, and thus herbicide screening for reed control could continuously be performed.

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Clinical Analysis of the Belsey Mark IV Operation in Hiatal Hernia with Gastroesophageal Reflux and Achalasia (위 식도 역류를 가진 열공 헤르니아 환자와 식도 무이완증 환자에서 시행한 Belsey Mark IV 수술의 임상적 고찰)

  • 최영호;조원민;류세민;황재준;손영상;김학제;김광택
    • Journal of Chest Surgery
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    • v.35 no.3
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    • pp.217-222
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    • 2002
  • Background: The incidence of gastroesophageal reflux disease(GERD) is increasing recently, but medical management for GERD has many limitations. Therefore, variable surgical treatments have been introduced. Material and Method: A retrospective study was done in 10 patients who underwent the Belsey Mark IV operation at Korea university Guro hospital between 1996 and 2001. Preoperative diagnoses were hiatal hernia with gasroesophageal reflux in 8 patients and achalasia in 2 patients. Result: Mean age of the patients was 54.3$\pm$19.0 years. Belsey Mark IV operation was performed on patients where preoperative medical failed and mean hospital days were 13.1$\pm$2.6 days. We routinely practiced follow-up endoscopy on postoperative 3rd, 6th, 9th, and 12th months. After remission for reflux and esophagitis, they were transferred to internal medicine department. Six patients of hiatal hernia with reflux (one patient who lost follow-up and the other patient who didn't practice the follow-up endoscopy due to short postoperative follow-up period were excluded) had lowered endoscopic gradings and two patients of achalasia did not complained of reflux symptoms, postoperatively. We experienced 10% operation failure rate. Conclusion: We experienced satisfactory operation results with Belsey Mark IV in hiatal hernia with GERD and achalasia patients.