• 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.

• Journal of Dairy Science and Biotechnology
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• v.34 no.2
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• pp.99-116
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• 2016

We herein performed animal safety assessment in accordance with Good Laboratory Practice (GLP) regulations with the aim of developing sialic acid from glycomacropeptide (hereafter referred to as "GMP") as an index ingredient and functional component in functional foods. GMP is a type of whey protein derived from milk and a safe food, with multiple functions, such as antiviral activity. A test substance was produced containing 7% (w/w) sialic acid and mostly-hydrolyzed whey protein (hereafter referred to as "7%-GNANA") by enzymatic treatment of substrate GMP. The maximum intake test dose level was selected based on 5,000 mg/kg/day dose set for male NOEL (no-observed-effect-level) and female NOAEL (no-observed-adverse-effect-level) determined by a dose-range finding (DRF) test (GLP Center of Catholic University of Daegu, Report No. 15-NREO-001) that was previously conducted with the same test substance. To evaluate the toxicity of a repeated oral dose of the test substance in connection with the previous DRF study, 1,250, 2,500, and 5,000 mg/kg of the substance were administered by a probe into the stomachs of 6-week-old SPF Sprague-Dawley male and female rats for 90 d. Each test group consisted of 10 male and 10 female rats. To determine the toxicity index, all parameters, such as observation of common signs; measurements of body weight and food consumption; ophthalmic examination; urinalysis, electrolyte, hematological, and serum biochemical examination; measurement of organ weights during autopsy; and visual and histopathological examinations were conducted according to GLP standards. After evaluating the results based on the test toxicity assessment criteria, it was determined that NOAEL of the test substance, 7%-GNANA, was 5,000 mg/kg/day, for both male and female rats. No animal death was noted in any of the test groups, including the control group, during the study period, and there was no significant difference associated with test substance, as compared with the control group, with respect to general symptoms, body weight changes, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemical examination, and electrolyte and blood coagulation tests during the administration period (P<0.05). As assessed by the effects of the test substance on organ weights, food consumption, autopsy, and histopathological safety, change in kidney weight as an indicator of male NOAEL revealed up to 20% kidney weight increase in the high-dose group (5,000 mg/kg/day) compared with the change in the control group. However, it was concluded that this effect of the test substance was minor. In the case of female rats, reduction of food consumption, increase of kidney weight, and decrease of thymus weight were observed in the high-dose group. The kidney weight increased by 10.2% (left) and 8.9% (right) in the high-dose group, with a slight dose-dependency compared with that of the control group. It was observed that the thymus weight decreased by 25.3% in the high-dose group, but it was a minor test substance-associated effect. During the autopsy, botryoid tumor was detected on the ribs of one subject in the high-dose group, but we concluded that the tumor has been caused by a naturally occurring (non-test) substance. Histopathological examination revealed lesions on the kidney, liver, spleen, and other organs in the low-dose test group. Since these lesions were considered a separate phenomenon, or naturally occurring and associated with aging, it was checked whether any target organ showed clear symptoms caused by the test substance. In conclusion, different concentrations of the test substance were fed to rats and, consequently, it was verified that only a minor effect was associated with the test substance in the high-dose (5,000 mg/kg/day) group of both male and female rats, without any other significant effects associated with the test substance. Therefore, it was concluded that NOAEL of 7%-GNANA (product name: Helicobactrol) with male and female rats as test animals was 5,000 mg/kg/day, and it thus was determined that the substance is safe for the ultimate use as an ingredient of health functional foods.

• 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.

• Journal of Food Hygiene and Safety
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• v.21 no.2
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• pp.100-106
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• 2006

The use of underarm and body care cosmetics with oestrogenic chemical excipients (particularly the parabens) and the hypothesized association with breast cancer incidence, particularly in women. It is noted that the type of cosmetic product is irrelevant (e.g. antiperspirant/deodorant versus body lotion, moisturizers or sprays versus creams) and attention must focus on issues of actual exposure to chemicals through continued dermal application of body care products and the endocrine/hormonal activity and toxicity of the chemicals in the formulations. To evaluate the estrogenic activities of parabens such as ethylparaben, butylparaben, propylparaben, isobutylparaben and isopropylparaben, we used recombinant yeasts containing the human estrogen receptor [Saccharomyces cerevisiae ER+LYS 8127], human breast cancer MCF-7 cell lines and human estrogen receptor ${\alpha}\;and\;{\beta}$. In E-screen assays, isopropylparaben is the most estrogenic paraben, and in ER competition assay, isobutylparaben is the most estrogenic paraben. We evaluated isopropylparaben was most active in the recombinant yeast assay, followed by propylparaben, ethylparaben, isobutylparaben and butylparaben. Results from this study demonstrate that parabens are observed in human endocrine system. Therefore, we have shown that the parabens is induced the estrogenic activities similar to $17{\beta}$-estradiol and Bisphenol-A.

• Korean journal of applied entomology
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• v.52 no.4
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• pp.395-402
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• 2013

Since 2000, a large number of molecular studies have been conducted in Hexapoda with generating large amount of mitochondrial sequences. In this study, to review mitochondrial COI sequences and their molecular studies reported in Hexapoda from 2000 to 2009, 488 molecular studies conducted based on 58,323 COI sequences were categorized according to 26 orders and the positions of COI sequences (5', 3', and entire regions). The numbers of molecular studies in which the three regions utilized varied largely among the 26 orders; however, seven orders showed preferred positions of COI sequences in the researches: Diptera and Orthoptera revealed the largest number of studies in the 5' region; while, Coleoptera, Phthiraptera, Odonata, Phasmatodea, and Psocoptera, showed the largest number of studies in the 3' region. From comparing 84 molecular studies published before 2000, we observed the possibilities that molecular studies in Coleoptera, Diptera, Phthiraptera, and Phasmatodea from 2000 to 2009 had been followed classical studies using the positions of COI sequences well-known until 1999. This study provides useful information to understand the overall trends in COI sequence usages as well as molecular studies conducted from 2000 to 2009 in Hexapoda.

• Korean journal of applied entomology
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• v.48 no.3
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• pp.335-345
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• 2009

Effect of four nematicidal herbal extracts (Daphne genkwa, Eugenia caryophyllata, Quisqualis indica and Zingiber officinale) and 3 acricidal herbal extracts (Pharbitis nil, Xanthium strumarium, and Desmodium caudatum) on entomopathobenic nematodes [Steinernema carpocapsae Pocheon strain (ScP) and Heterorhabditis sp. Gyeongsan strain (HG)], silkworm (Bombyx mori), and ground beetles (Synuchus sp.) were investigated in the laboratory and field. D. genkwa was highly toxic to SCP and HG (100% mortality) at the concentration of 5,000 ppm in X-plate. All the infective juveniles of HG were dead after 3 days by E. caryophyllata and Q. indica. The mortality of ScP and HG was below 10% by D. genkwa, D. caudatum, E. caryophyllata, Q. indica and Z. officinale at the concentration of 1,000 ppm two days after treatment while mortality of HG was 62.8% by D. genkwa at the concentration of 1,000 ppm in X-plate. However, 1,000 ppm had not effect on nematode survival and pathogenicity of ScP in sand column. On the contrary, E. caryophyllata had effect on pathogenicity of HG. Mean number of dead Galleria mellonella larva of HG was 0.5 in E. caryophyllata treatment. Q. indica did not effect silkworm reared on mulberry leaves at the treatment of 1,000 ppm in 10 days after treatment. However, there were 20.0 and 100% mortalities in the treatment of D. genkwa 3 and 10 days after treatment, respectively. The weight of silkworm was low in D. genkwa and did not pupate. The weight of pupa and cocoon were not different in E. caryophyllata, P. nil, Q. indica, X. strumarium and Z. officinale. D. genkwa, E. caryophyllata, P. nil, Q. indica and Z. officinale had no effect on ground beetles, Synuchus sp. in forest soil.

• Childhood Kidney Diseases
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• v.8 no.2
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• pp.129-137
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• 2004

Purpose : Nocternal enuresis is a common disorder. Tricyclic antidepressant and desmopressin have been accepted pharmacological treatment for this disorder We conducted a cooperative study to investigate the efficacy and adverse reactions of imipramine, desmopressin and combination treatment in children with primary monosymptomatic nocturnal enuresis(PMNE). Methods: Data from a large multicenter study were analysed. In the period of 8 months in 2002, the study comprised of 168 children(78 boys and 90 girls, 5 to 15 years old) with PMNE for imipramine, desmopressin or combination treatment. Before treatment a history, physical examination and laboratory tests were performed and the children were observed for 2 weeks. Response rate, adverse reactions and enuresis episodes after stopping drug administration were evaluated after 12-weeks of imipramine, desmopressin or combination of both. Results: After 4 weeks, the frequency of bed wetting in all treated patients decreased during treatment significantly Even though a 30-50%, reduction in the number of wet nights were 68.6%, 74.4% and 86.1% during 12 weeks treatment by imipramine, desmopressin and both of them respectively, there was no significant difference between them. The most common adverse reaction was decreased appetite from imipramine administration. But no serious drug-related adverse events were reported. Conclusion: Efficacy of the combination therapy of imipramine and desmopressin in PMNE appears not to be better than either drug alone. It is necessary to pay attention on account of adverse reactions during imipramine treatment even though imipramine and desmopressin were generally well tolerated.

• Journal of Astronomy and Space Sciences
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• v.22 no.3
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• pp.329-352
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• 2005

Long term observations of full-disk Lyman-o irradiance have been made by the instruments on various satellites. In addition, several sounding rockets dating back to the 1950s and up through the present have measured the $Lyman-{\alpha}$ irradiance. Previous full disk $Lyman-{\alpha}$ images of the sun have been very interesting and useful scientifically, but have been only five-minute 'snapshots' obtained on sounding rocket flights. All of these observations to date have been snapshots, with no time resolution to observe changes in the chromospheric structure as a result of the evolving magnetic field, and its effect on the Lyman-o intensity. The $Lyman-{\alpha}$ Imaging Solar Telescope(LIST) can provide a unique opportunity for the study of the sun in the $Lyman-{\alpha}$ region with the high time and spatial resolution for the first time. Up to the 2nd year development, the preliminary design of the optics, mechanical structure and electronics system has been completed. Also the mechanical structure analysis, thermal analysis were performed and the material for the structure was chosen as a result of these analyses. And the test plan and the verification matrix were decided. The operation systems, technical and scientific operation, were studied and finally decided. Those are the technical operation, mechanical working modes for the observation and safety, the scientific operation and the process of the acquired data. The basic techniques acquired through the development of satellite based solar telescope are essential for the construction of space environment forecast system in the future. The techniques which we developed through this study, like mechanical, optical and data processing techniques, could be applied extensively not only to the process of the future production of flight models of this kind, but also to the related industries. Also, we can utilize the scientific achievements which are obtained throughout the project And these can be utilized to build a high resolution photometric detectors for military and commercial purposes. It is also believed that we will be able to apply several acquired techniques for the development of the Korean satellite projects in the future.

• Clinical and Experimental Pediatrics
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• v.48 no.10
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• pp.1107-1115
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• 2005

Purpose : An outbreak of ESBL-producing Shigella sonnei enteritis was unprecedented not only in Korea but throughout the world in the past. We intended to devise a management guideline for ESBL-producing shigellosis based on analysis of clinical manifestations and response to therapy. Methods : We analyzed 103 patients who were admitted to the hospital with acute GI symptoms and were shown positive result for S. sonnei on stool culture. We performed sensitivity test to the antibiotics and DNA sequencing of ESBL gene in the isolated S. sonnei colonies. In addition, we retrospectively analyzed their clinical characteristics, laboratory results, and clinical and microbiological responses to the antibiotics. Results : Among the clinical manifestations, fever was the most frequent(96.1%), followed by diarrhea(93.2%), abdominal pain(76.7%), headache(71.8%), vomiting(65.0%), and nausea(41.7%). The fever was sustained for average of 2.0 days and diarrhea for 3.9 days. Watery diarrhea was the most common(69%) followed by mucoid(26%), and bloody stool(5%). On peripheral blood smear, leukocytosis was noted in 53.4% of patients, and 78.6% of patients tested positive for serum CRP response. On stool direct smear, 11.7% of patients showed more than 50 WBCs/HPF, and 9.7% of patients between 5 to 20 WBCs/HPF. Stool occult blood was positive in 71% of patients. Production of CTX-M-14 type ESBL was reported for all S. sonnei strains isolated from this outbreak. Microbiological eradication rates to various antibiotics were as follows : 100%(9/9) to ciprofloxacin, 100% 5/5) to azithromycin, 6.9%(5/72) to cefdinir, 0%(0/8) to ceftriaxone, 12.5%(1/8) to ceftizoxime, 0%(0/ 8) to TMP/SMX, 42.9%(3/7) to ampicillin/sulbactam, 20%(1/5) to amoxicillin/clavulanic acid, and 68.8 %(11/16) to imipenem/cilastatin. Conclusion : It is presumed that azithromycin can be an attractive option for the treatment of ESBL-producing S. sonnei enteritis in pediatric population, given its cost-effectiveness and safety. Although ciprofloxacin is another cost-effective agent, its use in pediatric population may be a bit too premature.

• Proceedings of the Materials Research Society of Korea Conference
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• 2011.05a
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• pp.5-5
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• 2011

The research and development of hybrid electric vehicle (HEV), plug-in hybrid electric vehicle (PHEV) and electric vehicle (EV) are intensified due to the energy crisis and environmental concerns. In order to meet the challenging requirements of powering HEV, PHEV and EV, the current lithium battery technology needs to be significantly improved in terms of the cost, safety, power and energy density, as well as the calendar and cycle life. One new technology being developed is the utilization of composite cathode by mixing two different types of insertion compounds [e.g., spinel $LiMn_2O_4$ and layered $LiMO_2$ (M=Ni, Co, and Mn)]. Recently, some studies on mixing two different types of cathode materials to make a composite cathode have been reported, which were aimed at reducing cost and improving self-discharge. Numata et al. reported that when stored in a sealed can together with electrolyte at $80^{\circ}C$ for 10 days, the concentrations of both HF and $Mn^{2+}$ were lower in the can containing $LiMn_2O_4$ blended with $LiNi_{0.8}Co_{0.2}O_2$ than that containing $LiMn_2O_4$ only. That reports clearly showed that this blending technique can prevent the decline in capacity caused by cycling or storage at elevated temperatures. However, not much work has been reported on the charge-discharge characteristics and related structural phase transitions for these composite cathodes. In this presentation, we will report our in situ x-ray diffraction studies on this mixed composite cathode material during charge-discharge cycling. The mixed cathodes were incorporated into in situ XRD cells with a Li foil anode, a Celgard separator, and a 1M $LiPF_6$ electrolyte in a 1 : 1 EC : DMC solvent (LP 30 from EM Industries, Inc.). For in situ XRD cell, Mylar windows were used as has been described in detail elsewhere. All of these in situ XRD spectra were collected on beam line X18A at National Synchrotron Light Source (NSLS) at Brookhaven National Laboratory using two different detectors. One is a conventional scintillation detector with data collection at 0.02 degree in two theta angle for each step. The other is a wide angle position sensitive detector (PSD). The wavelengths used were 1.1950 ${\AA}$ for the scintillation detector and 0.9999 A for the PSD. The newly installed PSD at beam line X18A of NSLS can collect XRD patterns as short as a few minutes covering $90^{\circ}$ of two theta angles simultaneously with good signal to noise ratio. It significantly reduced the data collection time for each scan, giving us a great advantage in studying the phase transition in real time. The two theta angles of all the XRD spectra presented in this paper have been recalculated and converted to corresponding angles for ${\lambda}=1.54\;{\AA}$, which is the wavelength of conventional x-ray tube source with Cu-$k{\alpha}$ radiation, for easy comparison with data in other literatures. The structural changes of the composite cathode made by mixing spinel $LiMn_2O_4$ and layered $Li-Ni_{1/3}Co_{1/3}Mn_{1/3}O_2$ in 1 : 1 wt% in both Li-half and Li-ion cells during charge/discharge are studied by in situ XRD. During the first charge up to ~5.2 V vs. $Li/Li^+$, the in situ XRD spectra for the composite cathode in the Li-half cell track the structural changes of each component. At the early stage of charge, the lithium extraction takes place in the $LiNi_{1/3}Co_{1/3}Mn_{1/3}O_2$ component only. When the cell voltage reaches at ~4.0 V vs. $Li/Li^+$, lithium extraction from the spinel $LiMn_2O_4$ component starts and becomes the major contributor for the cell capacity due to the higher rate capability of $LiMn_2O_4$. When the voltage passed 4.3 V, the major structural changes are from the $LiNi_{1/3}Co_{1/3}Mn_{1/3}O_2$ component, while the $LiMn_2O_4$ component is almost unchanged. In the Li-ion cell using a MCMB anode and a composite cathode cycled between 2.5 V and 4.2 V, the structural changes are dominated by the spinel $LiMn_2O_4$ component, with much less changes in the layered $LiNi_{1/3}Co_{1/3}Mn_{1/3}O_2$ component, comparing with the Li-half cell results. These results give us valuable information about the structural changes relating to the contributions of each individual component to the cell capacity at certain charge/discharge state, which are helpful in designing and optimizing the composite cathode using spinel- and layered-type materials for Li-ion battery research. More detailed discussion will be presented at the meeting.