• Korean Journal of Microbiology
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• v.44 no.3
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• pp.228-236
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• 2008

Validation of viral safety is essential in ensuring the safety of mammalian cell culture-derived biopharmaceuticals, because numerous adventitious viruses have been contaminated during the manufacture of the products. Mammalian cells are highly susceptible to Reovirus type 3 (Reo-3), and there are several reports of Reo-3 contamination during the manufacture of biopharmaceuticals. In order to establish the validation system for the Reo-3 safety, a real-time RT-PCR method was developed for quantitative detection of Reo-3 in cell lines, raw materials, manufacturing processes, and final products as well as Reo-3 clearance validation. Specific primers for amplification of Reo-3 RNA was selected, and Reo-3 RNA was quantified by use of SYBR Green I. The sensitivity of the assay was calculated to be $3.2{\times}10^0\;TCID_{50}/ml$. The real-time RT-PCR method was proven to be reproducible and very specific to Reo-3. The established real-time RT-PCR assay was successfully applied to the validation of Chinese hamster ovary (CHO) cell artificially infected with Reo-3. Reo-3 RNA could be quantified in CHO cell as well as culture supernatant. When the real-time RT-PCR assay was applied to the validation of virus removal during a virus filtration process, the result was similar to that of virus infectivity assay. Therefore, it was concluded that this rapid, specific, sensitive, and robust assay could replace infectivity assay for detection and clearance validation of Reo-3.

• The Korean Journal of Nuclear Medicine
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• v.37 no.4
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• pp.254-259
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• 2003

$^{99m}Tc-galactosyl$ human serum albumin (Tc-GSA) is a radiopharmaceutical that binds to asialoglycoprotein receptors, which are specifically present in the hepatocyte membrane. Because these receptors are decreased in hepatic parenchymal damage, the degree of Tc-GSA accumulation in the liver correlates with findings of liver function test. Hepatic images were performed with Tc-GSA in patients with acute hepatic dysfunction by Amantia Subjunquillea poisoning, and compared with these of liver ultrasonography (USG). Tc-GSA (185 MBq, 3 mg of GSA) was injected intravenously, and dynamic images were recorded for 30 minutes. Time-activity curves for the heart and liver were generated from regions of interest for the whole liver and precordium. Degree of hepatic uptake and clearance rate of Tc-GSA were generated by visual interpretation and semiquantitative analysis parameters (receptor index : LHL15 and index of blood clearance : HH15). Visual assessment of GSA scintigraphy revealed mildly decreased liver uptake in all of subjects. The mean LHL15 and HH15 were 0.886 and 0.621, graded as mild dysfunction in 2, and mild to moderate dysfunction in 1 subject. In contrast, liver USG showed no remarkable changes of hepatic parenchyme. Tc-GSA scintigraphy was considered as a useful imaging modality in the assessment of the hepatic dysfunction.

• Childhood Kidney Diseases
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• v.14 no.1
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• pp.22-31
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• 2010

Purpose : This study was performed to evaluate the relationship between glomerular basement membrane (GBM) alterations to epithelial cell (EpC) structure and renal function in Alport Syndrome (AS) patients. Methods : Fifteen patients diagnosed with AS (4-26yrs) were examined. The GBM in AS was categorized as : C1) normal, C2) minor alterations (widening of lamina rara interna or externa without lamina densa change), C3) nonspecific splitting of lamina densa, C4) basket-weaving pattern of lamina densa splitting. The length of each GBM portion along the epithelial side was measured on the systematically obtained electron microscopic photographs. Furthermore to obtain an objective assessment of the degree of glomerular EpC foot process change, the number of slit pores along $10\;{\mu}m$ of peripheral GBM in each category was obtained. Results : The percentage of normal GBM portion (C1) correlated inversely with daily protein excretion (g/day/$m^2$, P<0.05) and sum of the percentage of abnormal GBM portion (C2+C3+C4) had direct correlation with daily protein excretion (g/day/$m^2$, P<0.05). There were no significant relationships between the percentages of other categories of GBM alterations and creatinine clearance or protein excretion. There were no significant relationships between of creatinine clearance in relation to normal GBM(C1) portion as well as that in relation to sum of the percentage of abnormal GBM portion (C2+C3+C4). GBM abnormality did not correlate with age at biopsy. Conclusion : The extent of GBM structural abnormality is related to proteinuria in AS but the epithelial response is uniform even though the GBM ultrastructural lesions are not.

• Childhood Kidney Diseases
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• v.17 no.2
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• pp.57-64
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• 2013

Purpose: In children, 24-hour urine collections are unreliable for evaluating glomerular filtration rate (GFR) because of the difficulty of regulating voiding and the daily variation of urinary creatinine up to 25%. Additionally, creatinine clearance (Ccr) based on urinary creatinine is considered inaccurate. The purpose of this study was to compare estimated GFR determined using Ccr, formulas with serum cystatin C and creatinine, and $^{99m}Tc$-mercaptoacetyltriglycine (MAG3) dynamic renal scintigraphy. Methods: This retrospective study included 101 patients (age, <18 years) who visited Chung-Ang University Hospital between July 2011 and August 2012. GFR was estimated using 24-hour urinary creatinine, five formulas with serum creatinine and cystatin C, and $^{99m}Tc$-MAG3 renal scan. Results: Of the 101 patients, glomerular renal diseases were present in 60 patients (59.4%) and non-glomerular diseases were present in 41 patients (40.6%). There was a significant correlation between estimated GFR determined using $^{99m}Tc$-MAG3 renal scan and Ccr (r=0.389, P <0.001). The correlation values between estimated GFR determined using $^{99m}Tc$-MAG3 renal scan and each formula of Schwartz, Counahan-Barratt, Cockcroft-Gault, Filler and Lepage, and Bokencamp were 0.265 (P=0.007), 0.128 (P=0.044), 0.230 (P=0.021), 0.356 (P<0.001), and 0.355 (P <0.001), respectively. $^{99m}Tc$-MAG3 renal scan was correlated with estimated-GFR by all formulas in decreased renal function. Conclusion: Estimated GFRs determined using serum creatinine and cystatin C, and $^{99m}Tc$-MAG3 renal scan correlated well with estimated GFR determined using Ccr. $^{99m}Tc$-MAG3 renal scan may be replaced for evaluation of renal function with convenience in patients with renal disease and decreased renal function in childhood.

• The Korean Journal of Nuclear Medicine
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• v.39 no.3
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• pp.200-208
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• 2005

Purpose: Tc-99m labeled diethylenetriaminepentaacctic acid (DTPA)-coupled galactosylated human serum albumin (GSA) is a currently used imaging agent for asialoglycoprotein receptor (ASGPR) of the liver, but, it has several shortcomings. Recently a new ASGPR imaging agent, $^{99m}Tc$-lactosylated human serum albumin (LSA), with simple labeling procedure, high labeling efficiency, high stability was developed. In order to assess the feasibility of the $^{99m}Tc$-LSA as a ASGPR imaging radiopharmaceuticals, we performed biodistribution study of the tracer in liver injured mice model and the results were compared with histolgic data. Materals and Methods: To induce hepatic damage in ICR mice, diethylnitrosamine (DEN) ($60mg/kg/week{\times}5time$, low dose or $180mg/kg/week{\times}2times$, high dose) and thioacetamide (TAA) ($50mg/kg{\times}1time$) were administrated intraperitoneally. Degree of liver damage was evaluated by tissue hematoxilin-eosin stain, and expression of asialoglycoprotein receptor (ASGPR) was assessed by immunohistochemistry using ASGPR antibody. $^{99m}Tc$-LSA was intravenously administrated via tail vein in DEN or TAA treated mice, and biodistribution study of the tracer was also performed. Results: DEN treated mice showed ballooning of hepatocyte and inflammatory cell infiltration in low dose group and severe hapatocyte necrosis in high dose group, and low dose group showed higher ASGPR staining than control mice in immunohistochemical staining. TAA treated mice showed severe hepatic necrosis. $^{99m}Tc$-LSA Biodistribution study showed that mice with hepatic necrosis induced by high dose DEN or TAA revealed higher blood activity and lower liver activity than control mice, due to slow clearance of the tracer by the liver. The degree of liver uptake was inversely correlated with the degree of histologic liver damage. But low dose DEN treated mice with mild hepatic injury showed normal blood clearance and hepatic activity, partly due to overexpression of ASGPR in mice with mild degree hepatic injury. Conclusion: Liver uptake of $^{99m}Tc$-LSA was inversely correlated with degree of histologic hepatic injury in DEN and TAA treated mice. These results support that $^{99m}Tc$-LSA can be used to evaluate the liver status in liver disease patients.

• The Journal of The Korea Institute of Intelligent Transport Systems
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• v.4 no.1 s.6
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• pp.43-56
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• 2005

This research has examined a time series analysis(TSA) of an every hour traffic information such as occupancy, a traffic flow, and a speed, a statistical model of a surveyed data on the traffic fundamental diagram and an expand aspect of a traffic jam by many Parts of the traffic flow. Based on the detected data from traffic accidents on the Cheonan-Nonsan high way and events when the road volume decreases dramatically like traffic accidents it can be estimated from the change of occupancy right after accidents. When it comes to a traffic jam like events the changing gap of the occupancy and the mean speed is gentle, in addition to a quickness and an accuracy of a detection by the time series analyse of simple traffic index is weak. When it is a stable flow a relationship between the occupancy and a flow is a linear, which explain a very high reliability. In contrast, a platoon form presented by a wide deviation about an ideal speed of drivers is difficult to express by a statical model in a relationship between the speed and occupancy, In this case the speed drops shifty at 6$\~$8$\%$ occupancy. In case of an unstable flow, it is difficult to adopt a statistical model because the formation-clearance Process of a traffic jam is analyzed in each parts. Taken the formation-clearance process of a traffic jam by 2 parts division into consideration the flow having an accident is transferred to a stopped flow and the occupancy increases dramatically. When the flow recovers from a sloped flow to a free flow the occupancy which has increased dramatically decrease gradually and then traffic flow increases according as the result analyzed traffic flow by the multi regime as time series. When it is on the traffic jam the traffic flow transfers from an impeded free flow to a congested flow and then a jammed flow which is complicated more than on the accidents and the gap of traffic volume in each traffic conditions about a same occupancy is generated huge. This research presents a need of a multi-regime division when analyzing a traffic flow and for the future it needs a fixed quantity division and model about each traffic regimes.

• Journal of the Korean Society of Marine Environment & Safety
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• v.27 no.6
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• pp.789-797
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• 2021

The worldwide sizes of container ships are rapidly increasing. The container ship size in 2005, which was about 9,200 TEU has increased to 24,000 TEU in recent times. In addition to the increase in the sizes of the container ships, the arrivals/departures of large container vessels to/from Korea have also increased. Hence, the necessity for reviewing safe passage of such vessels is emphasized. In the present study, a 24,000 TEU container vessel was used as a model ship to calculate the under-keel clearance (UKC) at Gadeok Channel through which vessels must pass to arrive at Busan New Port, in accordance with the Korean Port and Fishing Port Design Standards and Commentary. In addition, the maximum allowable speed that meets UKC standards was calculated using various squat formulas, whose results were then compared with the current speed limit standards. The analysis results show that Busan New Port requires 10% marginal water depth, and the squat that meets this requirement is 0.95 m. Gadeok Channel requires 15% marginal water depth, and the squat that meets this requirement is 1.78 m; in this case, the maximum allowable speed is calculated as 15 kts. Busan New Port has set the speed limit as 12 kts, which is higher than the calculated 11 kts. Thus, speed limit reconsideration is required in terms of safety. However, the set speed limit for Gadeok Channel is 12 kts, which is lower than the calculated 15 kts. Thus, additional considerations may be provided to increase the speed limits for smooth navigational passage of vessels. The present study, however, is constrained by the fact that it reflects only a limited number of elements in the UKC and allowable speed calculations; therefore, more accurate UKC and safe speed values can be suggested based on extended studies to this research.

• Journal of Intelligence and Information Systems
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• v.29 no.1
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• pp.121-142
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• 2023

As the number and weight of imported food are steadily increasing, safety management of imported food to prevent food safety accidents is becoming more important. The Ministry of Food and Drug Safety conducts on-site inspections of foreign food facilities before customs clearance as well as import inspection at the customs clearance stage. However, a data-based safety management plan for imported food is needed due to time, cost, and limited resources. In this study, we tried to increase the efficiency of the on-site inspection by preparing a machine learning prediction model that pre-selects the companies that are expected to fail before the on-site inspection. Basic information of 303,272 foreign food facilities and processing businesses collected in the Integrated Food Safety Information Network and 1,689 cases of on-site inspection information data collected from 2019 to April 2022 were collected. After preprocessing the data of foreign food facilities, only the data subject to on-site inspection were extracted using the foreign food facility_code. As a result, it consisted of a total of 1,689 data and 103 variables. For 103 variables, variables that were '0' were removed based on the Theil-U index, and after reducing by applying Multiple Correspondence Analysis, 49 characteristic variables were finally derived. We build eight different models and perform hyperparameter tuning through 5-fold cross validation. Then, the performance of the generated models are evaluated. The research purpose of selecting companies subject to on-site inspection is to maximize the recall, which is the probability of judging nonconforming companies as nonconforming. As a result of applying various algorithms of machine learning, the Random Forest model with the highest Recall_macro, AUROC, Average PR, F1-score, and Balanced Accuracy was evaluated as the best model. Finally, we apply Kernal SHAP (SHapley Additive exPlanations) to present the selection reason for nonconforming facilities of individual instances, and discuss applicability to the on-site inspection facility selection system. Based on the results of this study, it is expected that it will contribute to the efficient operation of limited resources such as manpower and budget by establishing an imported food management system through a data-based scientific risk management model.

• Childhood Kidney Diseases
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• v.5 no.2
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• pp.78-86
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• 2001

Purpose: Rapidly progressive glomerulonephritis (RPGN) is characterized by the rapid increase in serum creatitnin and crescents formation involving more than $50\%$ of glomeruli. 10 patients who had been treated for RPGN were studied retrospectively for thier underlying diseases and clinical features Method: Cilinical review was performed on 10 children who were diagnosed with RPGN by clinical features and renal biopsy and followed up at department of pediatrics during tile last 10 years, from May 1990 to May 2000. Result: There were 6 males and 4 females between the ages of 2.1 and 14.3 years (mean $10.9{\pm}3.8$). 3 had Henoch-$Sch{\ddot{o}}nlein$ purpura nephritis; 2, idiopathic rapidly progressive glomerulonephritis; 2, lupus nephritis; 1, hemolytic uremic syndrome; 1, membranous glomerulonephritis and 1, microscopic polyangiitis. The most common chief complaints were gross hematuria and oliguria. Initial clinical features included proteinuria, edema, hypertension, nausea and arthralgia. Mean serum BUN was $74.2{\pm}39.1\;mg/dL$ mean serum creatinin, $3.2{\pm}1.8\;mg/dL$ and mean creatinin clearance, $26.5{\pm}13.2\;mL/min/1.73m^2$. Antineutrophil cytoplasmic antibody was positive only in microscopic polyangiitis. ANA and Anti-DNA antibody were positive in two lupus nephritis patients. Serum complements were decreased in 4 patients. All patients except Hemolytic uremic syndrome received steroid pulse therapy and immunosupressive agents. 3 patients were performed acute peritoneal dialysis and 2 patients were given plasmapheresis. At the last follow up, 1 patient was dead, 4 patients had elevated serum creatinin, 2 of these 4 patients were on chronic ambulatory peritoneal dialysis and 6 patients had normal renal function. Conclusion: Rapidly progressive glomerulonephritis is a medical emergency that requires very rapid diagnosis, classification, and therapy. Appropriate therapy selected on the basis of underlying disease mechanism can substantially improve renal survival. (J. Korean Soc Pediatr Nephrol 2001 ; 5 : 78-86)

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.2 no.2
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• pp.169-177
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• 1999

Purpose: To evaluate the efficacy of interferon alpha therapy with or without prednisolone in children with chronic hepatitis B. Methods: Twenty-eight children (22 boys, 6 girls, mean age 130 months) had seropositive results for HBsAg, HBeAg and HBV DNA; 11 had chronic persistent hepatitis and 17 had chronic active hepatitis. The patients were divided into two groups depending upon their inflammatory activity on liver biopsy, pretreatment serum ALT levels and HBV DNA levels. Fourteen children (group 1: chronic active hepatitis, ALT ${\geq}$ 100 IU/L and HBV DNA ${\leq}$ 100 pg/$300\;{\mu}L$) received interferon alpha 2a 5 $MU/m^2$ of body surface three times weekly for 6 months. Fourteen children (group 2: chronic persistent hepatitis or chronic active hepatitis with ALT < 100 IU/L or HBV DNA > 100 pg/$300\;{\mu}L$) received prednisolone in decreasing daily doses of 60 mg/$m^2$, 40 mg/$m^2$, and 20 mg/$m^2$, each for 2 weeks, followed after 2 weeks by interferon alpha 2a on the same schedule. At the end of therapy, 3 end points were analyzed: HBeAg seroconversion, serum ALT normalization rate and clearance of serum HBV DNA. Results: At the end of treatment, HBe antigen-to antibody seroconversion was higher but not more significant in group 1 than group 2 (71.4% vs. 50.0%). Only one patient in group 2 who lost HBeAg, also cleared HBsAg. ALT normalization was similar in both groups (64.3% in group 1 vs. 55.6% in group 2). Clearance of serum HBV DNA was observed in 78.6% of patients in group 1 and 64.3% in group 2, but no significant differences. Complete response was similarly achieved in both groups (57.1% in group 1 vs. 50.0% in group 2). Interferon alpha therapy with prednisolone priming was well tolerated and all children finished therapy. Conclusion: The combined therapy with prednisolone followed by interferon alpha may be safe and effective in inducing a serological and biochemical remission of the disease in approximately 50% of children with chronic hepatitis B and with a high level of viral replication and less active disease. However, a controlled study should be performed to confirm these results.