• Title/Summary/Keyword: 비임상실험관리기준

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A Case Study on the Design for Jeong-eup Second Safety Evaluation Tentative Research Institute (안전성평가연구소 정읍제2안전성평가시험연구동 설계사례)

  • Jung, Jong-Lim;Oh, Kun-Hyoan;Jung, Jae-Hun
    • Proceedings of the SAREK Conference
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    • 2008.06a
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    • pp.552-557
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    • 2008
  • This paper introduces to schematic design for Korea Institute of Toxicology Second Campus at Jeong-eup and provides fundamental information and data in order to design this laboratory facility to meet the criteria of G.L.P(Good Laboratory Practice), AAALAC(Association for Assessment and Accreditation of Laboratory Animal Care) and so on. This paper especially focus on design criteria, HVAC(Heating Ventilating and Air Conditioning) equipment and systems, plumbing equipment and systems, maintenance of equipment and systems and energy saving system of this laboratory facility.

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A Skin Color Analysis of Digital Color System for Ocular Inspection (망진을 위한 디지털 색체계의 피부색 분석)

  • Lee, Se-Hwan;Kim, Bong-Hyun;Ka, Min-Kyoung;Park, Sun-Ae;Cho, Dong-Uk
    • Proceedings of the Korea Information Processing Society Conference
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    • 2007.11a
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    • pp.86-89
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    • 2007
  • 현대 사회의 건강관리 분야에서 기존의 서양의학이 아닌 한의학을 이용하는 것에 관심이 증대되고 있는 실정이다. 이에 한의학의 진단 이론인 사진법 중 가장 뛰어난 망진을 활용한 진단기기의 개발이 의료비 절감 및 국민건강 증진에 기여할 것으로 사료된다. 본 논문에서는 망진 중 찰색을 위한 진단기술 개발을 위한 연구를 진행 하였으며 실험을 위해 일정한 환경을 설정하고 이와 같은 환경에서 임상자료를 수집하여 색상 분석을 실행하고 디지털 색 체계 분석을 위한 연구를 진행하였다. 특히 실험을 통해 찰색에 필요한 오색(흰색, 검정색, 빨간색, 파란색, 노란색)의 추출에 적합한 디지털 색 체계로서 LAB 색체계의 효율성을 밝히고 이를 통한 실제 피부색 비교 및 분석을 진행하였다. 최종적으로 실험의 의한 피부색 분석으로 찰색에 유용한 기준 설정을 행하고자 한다.

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Development of Health Functional Food Using the Standardized Materials from Red Ginseng(Panax ginseng) (홍삼소재를 활용한 건강기능식품 개발)

  • Park, Jong-Dae
    • Proceedings of the Plant Resources Society of Korea Conference
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    • 2011.10a
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    • pp.5-5
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    • 2011
  • 최근에 고령화 사회에 접어들면서 건강하게 활동하며 수명을 다하는 것이 중요한 연구과제가 되고 있다. 이 때문에 영양, 운동, 스트레스, 환경 등과 관련하여 암, 당뇨병, 고혈압, 비만, 동맥경화 등 생활습관병의 극복이 사회문제가 되고 있는 실정이다. 지금까지 고려인삼의 대표적인 동물실험 및 임상학적 연구결과를 종합하여 보면 성인의 난치성 만성질환에 대해서 치료제보다는 질병을 예방하고 회복촉진에 보다 큰 효과 있음을 확인할 수 있다. 이는 인삼이 식품과 의약품의 중간에 위치한 식품의약품(Nutraceutical)의 용도로 활용할 수 있음을 시사한다. 현재까지 인삼제품에 표시되는 기능성의 내용은 약 3,000여편 이상의 약리효능에 관련된 논문이 발표되었다 하더라도 "피로회복, 면역력 증진, 혈소판 응집 억제를 통한 혈액흐름에 도움이 됩니다"이며 이외의 기능성 표시는 현재로서 원칙적으로 불가한 것으로 되어 있다. 그러나 시험물질의 규격화 및 임상시험의 검토기준을 만족시키는 과학적 자료제출에 의한 개별 평가 후 표시내용의 확대가 가능하다. 고려인삼의 다양한 성분 중 ginsenoside는 주요 약효성분으로 인정을 받고 있으며 현재 품질관리의 지표성분으로 활용되고 있다. 이러한 개별 ginsenoside의 약리작용을 보면 서로 유사 또는 상반된 효과를 보여주는 성분들이 공존하고 있어 인삼의 다양한 약리효과와 일맥상통하는 것으로 보고되고 있다. 아울러, ginsenoside는 인삼의 부위 별로 현격한 차이를 보여주기 때문에 소재의 규격화는 매우 중요하다고 판단된다. 따라서, 인삼제품 개발의 가장 중요한 조건은 의약품에 가까운 기능성식품으로 세계적인 제품을 만들기 위해서는 표준화가 선행되어야 한다. 이와 같은 조건을 잘 충족시키는 제품이 스위스 "파마톤의 진사나(백삼추출물, G115)" 제품으로 생각할 수 있다. 따라서, 고려인삼의 수출시장 확대 및 세계적인 제품을 위해서는 진사나에 필적할 수 있는 새로운 홍삼의 표준화된 추출물을 도출하는 것이 무엇보다 급선무라 생각한다. 아울러 고려인삼의 특장점 발굴을 위한 표준화 된 추출분획물, 활성성분 및 효능과 연계한 새로운 고부가가치 창출제품(식품/의약품)개발에 주력해야 할 것이다.

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Studies on the Repeated Toxicity Test of Food Red No.2 for 4 Weeks Oral Administration in SD Rat (SD랫드에서 식용색소 적색2호의 4주간 경구투여에 따른 반복독성시험에 관한 연구)

  • Yoo, Jin-Gon;Jung, Ji-Youn
    • Journal of Food Hygiene and Safety
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    • v.27 no.1
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    • pp.42-49
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    • 2012
  • This study was carried out to investigate the toxicity of food Red No.2 in the Sprague-Dawley (SD) female rat for 4 weeks. SD rats were orally administered for 28 days, with dosage of 500, 1,000, 2,000 mg/kg/day. Animals treated with food Red No.2 did not cause any death and show any clinical signs. They did not show any significant changes of body weight, feed uptake and water consumption. There were not significantly different from the control group in urinalysis, hematological, serum biochemical value and histopathological examination. In conclusion, 4 weeks of the repetitive oral medication of food Red No.2 has resulted no alteration of toxicity according to the test materials in the group of female rats with injection of 2,000 mg/kg. Therefore, food Red No.2 was not indicated to have any toxic effect in the SD rats, when it was orally administered below the dosage 2,000 mg/kg/day for 4 weeks.

Quasi-breath-hold (QBH) Biofeedback in Gated 3D Thoracic MRI: Feasibility Study (게이트 흉부자기 공명 영상법과 함께 사용할 수 있는 의사호흡정지(QBH) 바이오 피드백)

  • Kim, Taeho;Pooley, Robert;Lee, Danny;Keall, Paul;Lee, Rena;Kim, Siyong
    • Progress in Medical Physics
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    • v.25 no.2
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    • pp.72-78
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    • 2014
  • The aim of the study is to test a hypothesis that quasi-breath-hold (QBH) biofeedback improves the residual respiratory motion management in gated 3D thoracic MR imaging, reducing respiratory motion artifacts with insignificant acquisition time alteration. To test the hypothesis five healthy human subjects underwent two gated MR imaging studies based on a T2 weighted SPACE MR pulse sequence using a respiratory navigator of a 3T Siemens MRI: one under free breathing and the other under QBH biofeedback breathing. The QBH biofeedback system utilized the external marker position on the abdomen obtained with an RPM system (Real-time Position Management, Varian) to audio-visually guide a human subject for 2s breath-hold at 90% exhalation position in each respiratory cycle. The improvement in the upper liver breath-hold motion reproducibility within the gating window using the QBH biofeedback system has been assessed for a group of volunteers. We assessed the residual respiratory motion management within the gating window and respiratory motion artifacts in 3D thoracic MRI both with/without QBH biofeedback. In addition, the RMSE (root mean square error) of abdominal displacement has been investigated. The QBH biofeedback reduced the residual upper liver motion within the gating window during MR acquisitions (~6 minutes) compared to that for free breathing, resulting in the reduction of respiratory motion artifacts in lung and liver of gated 3D thoracic MR images. The abdominal motion reduction in the gated window was consistent with the residual motion reduction of the diaphragm with QBH biofeedback. Consequently, average RMSE (root mean square error) of abdominal displacement obtained from the RPM has been also reduced from 2.0 mm of free breathing to 0.7 mm of QBH biofeedback breathing over the entire cycle (67% reduction, p-value=0.02) and from 1.7 mm of free breathing to 0.7 mm of QBH biofeedback breathing in the gated window (58% reduction, p-value=0.14). The average baseline drift obtained using a linear fit was reduced from 5.5 mm/min with free breathing to 0.6 mm/min (89% reduction, p-value=0.017) with QBH biofeedback. The study demonstrated that the QBH biofeedback improved the upper liver breath-hold motion reproducibility during the gated 3D thoracic MR imaging. This system can provide clinically applicable motion management of the internal anatomy for gated medical imaging as well as gated radiotherapy.

Comparative Pathology of chickens Experimentally Inoculated with Virulent Viscerotropic Newcastle Disease Viruses isolated in Korea (강병원성 뉴캣슬병 바이러스 한국분리주의 SPF 닭 접종에 따른 병리학적 변화 비교)

  • I. P. Mo;Y. K. Kwon;M. G. Han;H. W. Seong
    • Korean Journal of Poultry Science
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    • v.28 no.2
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    • pp.99-106
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    • 2001
  • Pathologic changes and distribution of viral antigen as determined by immunohistochemistry were compared among 4-wk-old specific-pathogen free (SPF) chickens inoculated intratracheally with velogenic vis-cerotropic Newcastle disease virus isolated in Korea. Although the pattern of organ involvement and severity of lesion was different among chickens infected with different velogenic viscerotropic Newcastle disease (VVND) viruses, the pathological types of lesion was similar among the chickens. Severe lymphocytic necrosis and depletion were main histologic lesions in the immune related organs such as thymus, Fabricius bursa and spleen. The frequency of IP positive staining was variable depends on the types of tissues but not types of the kinds of VVND viruses infected. Brain, Fabricius bursa, thymus, cecal tonsil and trachea were IP positive with fairly high frequency and spleen, lung, proventriculus, intestine, pancreas, liver, kidney, heart and Harderian gland were with relatively low frequency. These results suggest that histologic evaluation and viral antigen specific immunohistochemical staining methods to determine virus distribution will be useful for pathogenic study of velogenic viscerotropic Newcastle disease virus infection in chicken.

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Assessment of Renal Function in Silicobis with Urinary N-acetyl-$\beta$-D-glucosaminidase Activity (규폐증환자의 신기능 평가를 위한 요중 N-acetyl-$\beta$-D-glucosaminidase활성치 측정의 의의)

  • Lee, Hoo-Rak;Kim, Don-Kyoun;Lee, Su-Il;Cho, Byung-Mann;Kim, Wha-Jo
    • Journal of Preventive Medicine and Public Health
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    • v.26 no.1 s.41
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    • pp.49-64
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    • 1993
  • To provide the basic data for assessment of renal dysfunction related to silicosis, urinary N-acetyl-$\beta$-D-giucobarninidase(NAG) activity known as a sensitive markers for early renal damage were measured in 58 silicosis patients, and control subjects of 40 pulmonary tuberculosis Patients and 51 official workers. The results were summarized as fellows. 1. The values of blood urea nitrogen and serum creatinine in all subjects were within reference limits. But the mean value of urinary NAG activity($7.25{\pm}7.31U/g\;creatinine$) was beyond reference value and more sensitive test than others. 2. The mean value of urinary NAG activity in silicosis group was $11.98{\pm}9.05U/g\;creatinine$ and significantly higher than in tuberculosis and healthy group(p<0.01), but the mean values of NAG activity in tuberculosis and healthy group were not different(p>0.05). 3. The value of NAG activity in tuberculosis had a tendency to be increased according to severity of disease, but that was not significant(p>0.05). The value of NAG activity was increased significantly by use of nephrotoxic antituberculosis drugs(p<0.05). 4. The value of NAG activity in silicosis had a tendecy to be increased according to the size of nodule, use of nephrotoxic antituberculosis drugs and shortness of onset duration, but the increase was not significant(p>0.05). 5. After excluding the users of nephrotoxic antituberculosis drugs, the mean values of NAG activity in healthy control and in tuberculosis control were same as 3.63 U/g creatinine and 3.60 U/g creatinine, respectively. But the mean value of NAG activity in silicosis group was remarkably increased as 10.90 U/g creatinine(p<0.01). As above results, even though there are no abnormal finding in screening renal function test, silicosis can be related with renal dysfunction. And it will be very useful to apply urinary NAG activity in health management of workers exposed to dust.

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