• Title/Summary/Keyword: laboratory's safety

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Studies on the Cultural and Serological Tests of Mycoplasma Pulmonis in Laboratory Animal. (실험동물에 Mycoplasma Pulmonis의 배양 및 혈청학적 시험)

  • Kim Jae Yeon;Lee Yong Hee
    • Journal of environmental and Sanitary engineering
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    • v.1 no.1 s.1
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    • pp.69-79
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    • 1986
  • This studies were carried out to investigate the high infection sites from various specimens, cultural isolation on the susceptible media and specific antibody titres of M. pulmonis in experimental 310 mice and 330 rats obtained from two breeding facilities. Efficiency of complement faxation test (CF test) for detection of M. pulmonis antibody in mice and rats were compared directly with the diagnostic cultural isolation method. 1. Isolation rates of M. pulmonis among infection sites were about 30% from the oral cavities and $40\%$ from the middle ear of mice. The rates were $100\%$from the nasal cavaties and $90\%$ from the oral cavities of rats. 2. The infection rates were $12\%$ to A group and $16\%$ to B group of mice. The rates in the rats were $55\%$ to A group and $70\%$ to B group. 3. The M. pulmonis antibody titres by CF test were $73\%$ of total 100 mice in serum dilution below 1:5 (< 1:5), and $24\%$ of total samples in antibody titres above 1:5 (> 1:5), but 3 samples were not showed anticomplementary activities. The antibody titres in rats were $35\%$ of 120 rats in below 1:5 (< 1:5), and $61\%$ of total samples in above 1:5 (> 1:5), but the remained were not showed anticomplementary activities.

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Estimation of the Flash Point for n-Pentanol + n-Propanol and n-Pentanol + n-Heptanol Systems by Multiple Regression Analysis (다중회귀분석법을 이용한 n-Pentanol + n-Propanol계 및 n-Pentanol + n-Heptanol계의 인화점 예측)

  • Ha, Dong-Myeong;Lee, Sungjin
    • Fire Science and Engineering
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    • v.30 no.6
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    • pp.31-36
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    • 2016
  • The flash point is one of the most important properties for characterizing the fire and explosion hazard of liquid solutions. In this study, the flash points of two flammable binary mixtures, n-pentanol + n-propanol and n-pentanol + n-heptanol systems were measured using a Seta flash closed cup tester. The flash point was estimated using the methods based on Raoult's law and multiple regression analysis. The measured flash points were also compared with the predicted flash points. The absolute average errors (AAE) of the results calculated by Raout's law were $1.3^{\circ}C$ and $1.3^{\circ}C$ for the n-pentanol + n-propanol and n-pentanol + n-heptanol mixtures, respectively. The absolute average errors of the results calculated by multiple regression analysis were $0.4^{\circ}C$ and $0.3^{\circ}C$ for the n-pentanol + n-propanol and n-pentanol + n-heptanol mixtures, respectively. According to the AAE, the calculated values based on multiple regression analysis were better than those based on Raoult's law.

Assessment of Phytoplankton Viability Along the Salinity Gradient in Seomjin River Estuary, Korea (섬진강 하구역에서 염분구배에 따른 식물플랑크톤 활성도 평가)

  • Lim, Youngkyun;Baek, Seung Ho
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.23 no.5
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    • pp.513-523
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    • 2017
  • We evaluated the viability of phytoplankton along the salinity gradient in the flood and ebb tides of spring tide of February and the ebb tide of neap tide of March 2017 in the Seomjin River Estuary. Additional laboratory experiments were also conducted to determine the reason of the pH changes along the salinity gradient using the field natural sample in February. In field, saltwater was well mixed at downstream vertically and the salinity gradient was horizontally appeared toward upstream of freshwater zone. There were strong negative correlations between salinity and nutrient (nitrate + nitrite R=0.99, p<0.001, and silicate R=0.98, p<0.001), implying that those two nutrients of freshwater origin were gradually diluted with mixing the saltwater. On the other hands, relatively high phosphate concentration was kept in the stations of saltwater over 15 psu, indicating that it was caused by resuspended sediments of Gwangyang Bay and downstream by tidal water mixing.Among phytoplankton community structure in winter, Eucampia zodiacus have occupied to be c.a. 70 % in the most stations. Based on the field survey results for survivability of phytoplankton by phytoPAM instrument, there was positive correlations between salinity and chlorophyll a (R=0.82, p<0.001) and, salinity and active chlorophyll a (R=0.80, p<0.001), implying that the dominant marine diatom species may have significantly damaged in low salinity conditions of upstream. Also, maximum mortality rate of phytoplankton caused by low salinity shock was appered to be 75% in the upstream station. In particular, the pH in spring tides of February had tended to increase with high phytoplankton accmulated stations, suggesting that it was related with absorption of $CO_2$ by the photosynthesis of dominant diatom. In laboratory experiments, phytoplankton mass-mortality caused by low salinity shock was also occurred, which is confirmed with reducing the photosynthetic electron transport activity. Following the phytoplankton mass-mortality, bacteria abundance was significantly increased in 24 hours. As a result, the mass-proliferating bacteria can produce the $CO_2$ in the process of biodegradation of diatoms, which can lead to pH decrease. Therefore, marine phytoplankton species was greatly damaged in freshwater mixing area, depending on along the salinity gradient that was considered to be an important role in elevating and reducing of pH in Seomjin River Estuary.

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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A Proposal for Research Process of Botanical Drug based Clinical Traditional Korean Medicine - Historical Evidence-Based Medicine II - (한의학임상에 기초를 둔 천연물신약 연구과정에 대한 소고 - 역사적 근거 발굴부터 천연물신약 임상시험계획승인신청까지 -)

  • Eom, Seok-ki;Kim, Se-hyun;Kim, Kyung-suk;Park, Sang-jae;Eo, Wan-kyu;Choi, Won-cheol
    • Journal of Korean Medical classics
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    • v.23 no.4
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    • pp.63-102
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    • 2010
  • Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group's experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group's experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.

The Inflence of Excavation Damaged Zone around an Underground Research Tunnel in KAERI (한국원자력연구원 내 지하처분연구시설 주변의 암반 손상대 영향 평가)

  • Kwon, S.;Kim, J.S.;Cho, W.J.
    • Explosives and Blasting
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    • v.26 no.2
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    • pp.11-19
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    • 2008
  • The development of an excavation damaged zone, EDZ, due to the blasting impact and stress redistribution after excavation, can influence on the long tenn stability, economy, and safety of the underground excavation. In this study, the size and characteristics of an EDZ around an underground research tunnel, which was excavated by controlled blasting, in KAERI were investigated. The results were implemented into the modelling for evaluating the influence of an EDZ on hydro-mechanical behavior of the tunnel. From in situ tests at KURT, it was possible to determine that the size of EDZ was about l.5rn. Goodman jack tests and laboratory tests showed that the rock properties in the EDZ were changed about 50% compared to the rock properties before blasting. The size and property change in the EDZ were implemented to a hydro-mechanical coupling analysis. In the modeling, rock strengths and elastic modulus were assumed to be decreased 50% and. the hydraulic conductivity was increased 1 order. From the analysis, it was possible to see that the displacement was increased while the stress was decreased because of an EDZ. When an EDZ was considered in the model, the tunnel inflow was increased about 20% compared to the case without an EDZ.

Effects of low-dose topiramate on language function in children with migraine

  • Han, Seung-A;Yang, Eu Jeen;Kong, Younghwa;Joo, Chan-Uhng;Kim, Sun Jun
    • Clinical and Experimental Pediatrics
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    • v.60 no.7
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    • pp.227-231
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    • 2017
  • Purpose: This study aimed to verify the safety of low-dose topiramate on language development in pediatric patients with migraine. Methods: Thirty newly diagnosed pediatric patients with migraine who needed topiramate were enrolled and assessed twice with standard language tests, including the Test of Language Problem Solving Abilities (TOPs), Receptive and Expressive Vocabulary Test, Urimal Test of Articulation and Phonology, and computerized speech laboratory analysis. Data were collected before treatment, and topiramate as monotherapy was sustained for at least 3 months. The mean follow-up period was $4.3{\pm}2.7months$. The mean topiramate dosage was 0.9 mg/kg/day. Results: The patient's mean age was $144.1{\pm}42.3months$ (male-to-female ratio, 9:21). The values of all the language parameters of the TOPs were not changed significantly after the topiramate treatment as follows: Determine cause, from $15.0{\pm}4.4$ to $15.4{\pm}4.8$ (P>0.05); making inference, from $17.6{\pm}5.6$ to $17.5{\pm}6.6$ (P>0.05); predicting, from $11.5{\pm}4.5$ to $12.3{\pm}4.0$ (P>0.05); and total TOPs score, from $44.1{\pm}13.4$ to $45.3{\pm}13.6$ (P>0.05). The total mean length of utterance in words during the test decreased from $44.1{\pm}13.4$ to $45.3{\pm}13.6$ (P<0.05). The Receptive and Expressive Vocabulary Test results decreased from $97.7{\pm}22.1$ to $96.3{\pm}19.9months$, and from $81.8{\pm}23.4$ to $82.3{\pm}25.4months$, respectively (P>0.05). In the articulation and phonology validation in both groups, speech pitch and energy were not significant, and all the vowel test results showed no other significant values. Conclusion: No significant difference was found in the language-speaking ability between the patients; however, the number of vocabularies used decreased. Therefore, topiramate should be used cautiously for children with migraine.

Numerical Investigation of the Density and Inlet Velocity Effects on Fiber Orientation Inside Fresh SFRSCC (SFRSCC의 섬유 방향성에 미치는 입구 속도와 점성의 영향성에 대한 수치해석)

  • Azad, Ali;Lee, Jong-Jae;Lee, Jong-Han;Lee, Gun-Jun;An, Yun-Kyu
    • Journal of the Korea institute for structural maintenance and inspection
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    • v.22 no.3
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    • pp.16-20
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    • 2018
  • Steel Fiber reinforced self-compacting concrete (SFRSCC) has been widely used in a number of structures, such as ordinary civil infrastructures, sky scrapers, nuclear power plants, hospitals, dams, channels and etc. Thanks to its short and discrete reinforcing fibers, its performance, including tensile strength, ductility, toughness and flexural strength gets much better in comparison with ordinary self-compacting concrete (SCC) without any reinforcing fibers. Despite all these aforementioned advantages of SFRSCC, its performance highly depends on fiber's orientation. In case of short discrete fibers, the orientation of fibers is completely random and cannot be controlled during pumping process. If fibers distribution inside hardened state concrete are randomly distributed, it leads to less resistance potential of concrete element, especially in terms of flexural and tensile strength. The maximum expected strength may not be achieved. Therefore, fiber alignment has been considered as one of the important factors in SFRSCC. To address this issue, this study investigates the effects of concrete matrix's density and inlet velocity on fiber alignment during the pumping process using a finite element method.

Clinical Efficacy of Erdosteine in Patients with Acute or Chronic Bronchitis -A Randomized, Double Blind, Comparative Study vs. Ambroxol- (급.만성 기관지염 환자에서 엘도스$^{(R)}$(Erdosteine)의 임상효과 -염산 암브록솔과의 무작위 이중맹검 비교시험-)

  • Kim, Seok-Chan;Lee, Sang-Hoak;Song, So-Hyang;Kim, Young-Kyoon;Moon, Hwa-Sik;Song, Jeong-Sup;Park, Sung-Hak
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.6
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    • pp.1296-1307
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    • 1997
  • Background : Erdosteine is a thiol derivative developed for the treatement of chronic obstructive bronchitis, including acute infective exacerbation of chronic bronchitis. Erdosteine has mucomodulating and antioxidant properties and especially exhibits excellent gastrointestinal tolerability. Methods : The study was conducted as a prospective evaluation, with 2 comparative groups orally treated with erdosteine 300mg (bid.) or ambroxol 30mg (b.i.d.) for 7 days and the design of trial was double-blind. The treatments have been assigned randomly to patients (n=80) with acute or chronic bronchitis. The primary end-point used to determine efficacy in this study was subjective symptoms including expectorating frequence, expectoration volume, expectorating difficulty, expectoration viscosity, cough intensity and dyspnea. The secondary end-points of efficacy was the result of arterial blood gas analysis and pulmonary function test. Safety was evaluated with adverse drug reactions and laboratory tests monitoring. 61 patients was included in the efficacy analysis, due to the fact that 19 patients drop-out for different reasons. The obtained values have been analyzed with paired Hest., ANOVA test., multivariate $t^2$-test, repeated measures analysis of covariance, two sample t-test, loglinear-logit model analysis, Fisher's exact test. Results : 1) There was no significant difference on demographic data and vital signs between erdosteine and ambroxol treated groups. 2) The comparison between erdosteine and ambroxol treated groups showed no significant difference in improvement of each symptom in spite of the more favorable efficacy obtained with erdosteine. No difference on the contrary was observed for arterial blood gas analysis and pulmonary function test. 3) As safety is concerned, no clinical significant changes in laboratory test and symptom were induced in erdosteine and ambroxol treated group and two patients in ambroxol treated group drop-out for adverse reactions in symptom. 4) In the evaluation of final clinical efficacy, erdosteine improved more effectively patient's overall symptoms {very good effect (11/31), good effect (12/31), moderate effect (6/31), no effect (2/31), aggravation (0/31)} than ambroxol {very good effect (6/30), good effect (14/30), moderate effect (5/30), no effect (4/30), aggravation (2/30)}. And the probability of symptomatic improvement by erdosteine compared to ambroxol was 2.5 times. (p<0.05). Conclusion : This study showed that erdosteine was clinically effective and safe drug for treatment of acute and chronic bronchitis.

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Development of Calcification-Resistant Bovine Pericardium with $PEO-SO_3$ (I) - An implantation study of bovine pericardium at aorta and pulmonary artery in canine model - ($PEO-SO_3$를 이용한 항석회화 조직첨포의 개발 (I) - 잡견을 이용한 대동맥과 폐동맥 이식 실험연구 -)

  • Kim, Hyoung-Mook;Baek, Man-Jong;Sun, Kyung;Kim, Kwang-Taik;Lee, In-Sung;Kim, Hark-Jei;Lee, Won-Kyu;Park, Ki-Dong
    • Journal of Chest Surgery
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    • v.31 no.10
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    • pp.919-923
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    • 1998
  • Background: Calcific degeneration is unavoidable in either homo- or heterografts implanted in the human body. We have developed a calcification-resistant cardiovascular tissue patch using a novel technique of anticalcification. Materials and methods: Fresh bovine pericardium was harvested at the slaughter house and transfered to the laboratory in Hank's solution. After trimming and fixing the pericardium, it was embedded in 4$^{\circ}C$ 0.65% glutaraldehyde for a week and then washed by phosphate-buffered saline(PBS) of pH 7.4. This prepared pericardium was then stored in 2.5% sulphonated polyethyleneoxide(PEO-SO3) solution for 2 days at room temperature and reversed by 4$^{\circ}C$ NaBH4 solution for 16 hours. To evaluate the calcification-resistance of surface modified bovine pericardium with PEO-SO3, either glutaraldehyde- treated(GA group, n=4) or PEO-SO3-treated pericardial patch(PEO-SO3 group, n=4) was implanted into adult mongrel dog to reconstruct the main pulmonary artery and the descending aorta using a partial clamp technique. After 1 month follow-up, the implanted patches were retrieved to evaluate the pathologic findings and the content of calcium and phosphorous. Results: The PEO-SO3 group showed substantially less retraction and significantly less calcium deposition than the GA group in both aortic(7.10$\pm$1.05 vs. 13.81$\pm$2.33 mg/g of dried tissue) and pulmonary positions(1.55$\pm$0.29 vs. 6.72$\pm$0.70 mg/g)(p<0.01). Phosphorous contents were also less in the PEO-SO3 group than the GA group significantly, 8.11$\pm$1.07 mg/g vs. 19.33$\pm$4.31 mg/g in the aortic and 2.58$\pm$0.40 vs. 12.60$\pm$3.40 mg/g in thepulmonary position(p<0.01). Conclusions: These findings suggest that PEO-SO3 modified bovine pericardium is highly calcification-resistant but further study is needed to evaluate the long-term biological safety and compatibility of the prosthesis.

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