• Title/Summary/Keyword: Failure Criteria

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Bioequivalence of Stapin ER Tablet to Splendil ER Tablet (Felodipine 5 mg) (스프렌딜 지속정(펠로디핀 5 mg)에 대한 스타핀 지속정의 생물학적동등성)

  • Cho, Hea-Young;Kang, Hyun-Ah;Lee, Suk;Baek, Seung-Hee;Park, Eun-Ja;Choi, Hoo-Kyun;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.33 no.4
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    • pp.311-317
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    • 2003
  • Felodipine is a calcium antagonist that lowers blood pressure by reducing peripheral resistance by meas of a direct, selective action on smooth muscle in arterial resistance vessels. Futhermore, it have been approved for the effective in angina pectoris and cardiac failure. The purpose of the present study was to evaluate the bioequivalence of two felodipine extended release (ER) tablets, Splendil (YuHan Corporation) and Stapin (Hana Pharmaceutial Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The felodipine release from the two felodipine formulations in vitro was tested using KP VIII Apparatus II method at pH 6.5 buffer solution. Twenty six healthy male subjects, $22.73{\pm}1.78$ years in age and $66.66{\pm}7.28\;kg$ in body weight, were divided into two groups and a radomized $2{\times}2$ cross-over study was employed. After two tablets containing 5 mg as felodipine were orally administered, blood sample was taken at predetermined time intervals and the concentrations of felodipine in serum were determined using column-switching HPLC method with UV detector. The dissolution profiles of two formulations were similar at pH 6.5 buffer solution. Besides, the pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t\;and\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Splendil were 2.53%, 1.32% and 18.32% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance rage of log(0.86) to log(1.25) $(e.g.,\;log(0.86){\sim}log(1.20)\;and\;log(0.89){\sim}log(1.23)\;for\;AUC_t,\;C_{max},\;respectively)$. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Stapin ER tablet and Splendil ER tablet are bioequivalent.

Experimental Analysis for Characteristics of Bank-Scour around Barrier (수리실험을 통한 보 연결부 제방 세굴 특성 분석)

  • Jeong, Seok Il;Lee, Seung Oh
    • Journal of the Korean Society of Safety
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    • v.32 no.4
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    • pp.34-39
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    • 2017
  • Typical flow regime of overflow at barrier or weir constructed in mid and small streams becomes as the submerged flow during most flood events. One of major causes of barrier failure has been reported as the levee-scour near the conjuction node between barrier and levee. However, most related design guidelines in Korea have not mentioned about the protection of levee around barrier or weir in detail. Furthermore, most previous researches have focused on the flow characteristics of overflow around several types of weirs but they did not have considered the material properties of levee itself. In this study, local scour near barrier was investigated with different material properties of levee under the submerged overflow condition which is assumed to reenact a flood event. Based on results from Fritz et al. and Mavis et al., a theoretical formula was also proposed in initial stage of laboratory experiments. And hydraulic experiments were carried out for the verification of the proposed formula. Levee was installed in the prismetic trapezoidal open channel and most parts were made of concrete except for movable section in which scour was expected to occur for the efficiency of experimental procedure. Each compaction of movable section in levee was followed by the basis of the KS F 2312. Further, after performing the experiments to find the optimum water content for each sediment, the specific amount of water was injected before flowing water. The difference between the proposed theoretical formula and experiment results was not much but considerable, which might be caused by the effect of compaction. For theoretical approach, it seemed that the formula did not take into account the compaction of levee, thus the correction coefficient for levee compaction determined in the literature was considered. Finally, the formula for the length of scour around barrier or weir was proposed, which can be useful to predict a levee in the reference design of revetment in mid and small streams. As shortly future study, scour length of levee around barrier or weir under different flow conditions such as perfect overflow condition will be studied and it will be able to contribute to suggest the design formula or criteria under all overflow conditions near barrier or weir.

Treatment Outcome and Prognostic Factors of Cushing's Disease in Adults (성인 쿠싱병의 치료성적과 예후인자)

  • Park, Chul-Kee;Hwang, Sung Kyun;Gwak, Ho-Shin;Yoo, Heon;Chung, Young Seob;Paek, Sun Ha;Kim, Dong Gyu;Jung, Hee-Won;Kim, Seong Yeon;Hong, Seung Kuan
    • Journal of Korean Neurosurgical Society
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    • v.29 no.10
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    • pp.1316-1321
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    • 2000
  • Objectives : The authors analyzed the surgical series of Cushing's disease to evaluate the proper treatment policy and to verify the possible prognostic factors. Material and Methods : Of 50 patients diagnosed as Cushing's disease and operated at Department of Neurosurgery of our institute between 1988 and 1999, 48 patients with available medical records were analyzed retrospectively. Mean follow-up period was 48 months(3 to 109 months). Preoperative diagnosis was made after evaluating the patients with multiple-stage endocrinological studies and 31 selective patients were evaluated with inferior petrosal sinus sampling(IPSS). Magnetic resonance imaging(MRI) and/or high resolution computerized tomography(CT) was done in all patients. A total of 51 transsphenoidal adenomectomy(TSA) were performed including 3 revision for initial surgical failure cases. Remission was decided on the basis of both endocrinological criteria and clinical status. Radiation and/or ketoconazole therapy were applied to failed cases. For the verification of prognostic factors, the authors evaluated the statistical significance of multiple variables over remission rate by chi-square test. Result : Sensitivity of IPSS for central localization was 93.5% which was better than that of MRI(87.5%). But for lateralization, it was 72.4% for IPSS versus MRI 90.5%. Success rate of TSA was 82%(42/51) and recurrence rate was 9%(4/48). When including adjuvant treatments for surgically failed cases, overall success rate was 89.6% and all of 3 reoperated cases(TSA) due to recurrence were successful. Significant complication occurred in 7.8%(4/51) after TSA including hypopituitarism, diabetes insipidus, and visual loss. Non-existence of tumor in MRI and prolonged symptom duration(>3 years) were significant prognostic factors. Conclusion : TSA can be considered as initial treatment for Cushing's disease. In surgically failed cases, multiple treatment modality may improve the overall outcome and repeated TSA for recurrent cases seem to provide similar success.

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A Study on the Prediction Model of the Elderly Depression

  • SEO, Beom-Seok;SUH, Eung-Kyo;KIM, Tae-Hyeong
    • The Journal of Industrial Distribution & Business
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    • v.11 no.7
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    • pp.29-40
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    • 2020
  • Purpose: In modern society, many urban problems are occurring, such as aging, hollowing out old city centers and polarization within cities. In this study, we intend to apply big data and machine learning methodologies to predict depression symptoms in the elderly population early on, thus contributing to solving the problem of elderly depression. Research design, data and methodology: Machine learning techniques used random forest and analyzed the correlation between CES-D10 and other variables, which are widely used worldwide, to estimate important variables. Dependent variables were set up as two variables that distinguish normal/depression from moderate/severe depression, and a total of 106 independent variables were included, including subjective health conditions, cognitive abilities, and daily life quality surveys, as well as the objective characteristics of the elderly as well as the subjective health, health, employment, household background, income, consumption, assets, subjective expectations, and quality of life surveys. Results: Studies have shown that satisfaction with residential areas and quality of life and cognitive ability scores have important effects in classifying elderly depression, satisfaction with living quality and economic conditions, and number of outpatient care in living areas and clinics have been important variables. In addition, the results of a random forest performance evaluation, the accuracy of classification model that classify whether elderly depression or not was 86.3%, the sensitivity 79.5%, and the specificity 93.3%. And the accuracy of classification model the degree of elderly depression was 86.1%, sensitivity 93.9% and specificity 74.7%. Conclusions: In this study, the important variables of the estimated predictive model were identified using the random forest technique and the study was conducted with a focus on the predictive performance itself. Although there are limitations in research, such as the lack of clear criteria for the classification of depression levels and the failure to reflect variables other than KLoSA data, it is expected that if additional variables are secured in the future and high-performance predictive models are estimated and utilized through various machine learning techniques, it will be able to consider ways to improve the quality of life of senior citizens through early detection of depression and thus help them make public policy decisions.

Fault Injection Based Indirect Interaction Testing Approach for Embedded System (임베디드 시스템의 결함 주입 기반 간접 상호작용 테스팅 기법)

  • Hossain, Muhammad Iqbal;Lee, Woo Jin
    • KIPS Transactions on Software and Data Engineering
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    • v.6 no.9
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    • pp.419-428
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    • 2017
  • In an embedded system, modules exchange data by interacting among themselves. Exchanging erroneous resource data among modules may lead to execution errors. The interacting resources produce dependencies between the two modules where any change of the resources by one module affects the functionality of another module. Several investigations of the embedded systems show that interaction faults between the modules are one of the major cause of critical software failure. Therefore, interaction testing is an essential phase for reducing the interaction faults and minimizing the risk. The direct and indirect interactions between the modules generate interaction faults. The direct interaction is the explicit call relation between the modules, and the indirect interaction is the remaining relation that is made underneath the interface that possesses data dependence relationship with resources. In this paper, we investigate the errors that are based on the indirect interaction between modules and introduce a new test criterion for identifying the errors that are undetectable by existing approaches at the integration level. We propose a novel approach for generating the interaction model using the indirect interaction pattern and design test criteria that are based on different interaction errors to generate test cases. Finally, we use the fault injection technique to evaluate the feasibility and effectiveness of our approach.

Prognostic factors for survivals from first relapse in breast cancer patients: analysis of deceased patients

  • Kim, Haeyoung;Choi, Doo Ho;Park, Won;Huh, Seung Jae;Nam, Seok Jin;Lee, Jeong Eon;Ahn, Jin Seok;Im, Young-Hyuck
    • Radiation Oncology Journal
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    • v.31 no.4
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    • pp.222-227
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    • 2013
  • Purpose: This study was performed to evaluate prognostic factors for survival from first relapse (SFFR) in stage I-III breast cancer patients. Materials and Methods: From June 1994 to June 2008, 3,835 patients were treated with surgery plus postoperative radiotherapy and adjuvant chemotherapy for stage I-III breast cancer at Samsung Medical Center. Among them, a total of 224 patients died by June 2009, and 175 deaths were of breast cancer. Retrospective review was performed on medical records of 165 patients who met the inclusion criteria of this study. Univariate and multivariate analysis were done on survivals according to variables, such as age, stage, hormone status of tumor, disease-free interval (DFI), sites of first failure, number of organs involved by recurrent disease (NOR), application of salvage treatments, and existence of brain or liver metastasis (visceral metastasis). Results: Patients' median overall survival time was 38 months (range, 8 to 123 months). Median SFFR was 17 months (range, 5 to 87 months). Ninety percent of deaths occurred within 40 months after first recurrence. The patients with SFFR ${\leq}1$ year had tendency of triple-negativity, shorter DFI (${\leq}2$ years), larger NOR (>3), visceral metastasis for first relapse than the patients with SFFR >1 year. In multivariate analysis, longer DFI (>2 vs. ${\leq}2$ years), absence of visceral metastasis, and application of salvage treatments were statistically significant prognosticators for longer SFFR. Conclusion: The DFI, application of salvage treatments, and visceral metastasis were significant prognostic factors for SFFR in breast cancer patients.

Shear Friction Strength Model of Concrete considering Transverse Reinforcement and Axial Stresses (축응력 및 횡보강근을 고려한 콘크리트의 전단마찰내력 평가모델)

  • Hwnag, Yong-Ha;Yang, Keun-Hyeok
    • Journal of the Korea Concrete Institute
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    • v.28 no.2
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    • pp.167-176
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    • 2016
  • Shear friction strength model of concrete was proposed to explain the direct friction mechanism at the concrete interfaces intersecting two structural elements. The model was derived from a mechanism analysis based on the upper-bound theorem of concrete plasticity considering the effect of transverse reinforcement and applied axial loads on the shear strength at concrete interfaces. Concrete was modelled as a rigid-perfectly plastic material obeying modified Coulomb failure criteria. To allow the influence of concrete type and maximum aggregate size on the effectiveness strength of concrete, the stress-strain models proposed by Yang et al. and Hordijk were employed in compression and tension, respectively. From the conversion of these stress-strain models into rigidly perfect materials, the effectiveness factor for compression, ratio of effective tensile strength to compressive strength and angle of concrete friction were then mathematically generalized. The proposed shear friction strength model was compared with 91 push-off specimens compiled from the available literature. Unlike the existing equations or code equations, the proposed model possessed an application of diversity against various parameters. As a result, the mean and standard deviation of the ratios between experiments and predictions using the present model are 0.95 and 0.15, respectively, indicating a better accuracy and less variation than the other equations, regardless of concrete type, the amount of transverse reinforcement, and the magnitude of applied axial stresses.

Development of Long-Term Electricity Demand Forecasting Model using Sliding Period Learning and Characteristics of Major Districts (주요 지역별 특성과 이동 기간 학습 기법을 활용한 장기 전력수요 예측 모형 개발)

  • Gong, InTaek;Jeong, Dabeen;Bak, Sang-A;Song, Sanghwa;Shin, KwangSup
    • The Journal of Bigdata
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    • v.4 no.1
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    • pp.63-72
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    • 2019
  • For power energy, optimal generation and distribution plans based on accurate demand forecasts are necessary because it is not recoverable after they have been delivered to users through power generation and transmission processes. Failure to predict power demand can cause various social and economic problems, such as a massive power outage in September 2011. In previous studies on forecasting power demand, ARIMA, neural network models, and other methods were developed. However, limitations such as the use of the national average ambient air temperature and the application of uniform criteria to distinguish seasonality are causing distortion of data or performance degradation of the predictive model. In order to improve the performance of the power demand prediction model, we divided Korea into five major regions, and the power demand prediction model of the linear regression model and the neural network model were developed, reflecting seasonal characteristics through regional characteristics and migration period learning techniques. With the proposed approach, it seems possible to forecast the future demand in short term as well as in long term. Also, it is possible to consider various events and exceptional cases during a certain period.

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Body Mass Index as a Predictor of Acute Kidney Injury in Critically Ill Patients: A Retrospective Single-Center Study

  • Ju, Sunmi;Lee, Tae Won;Yoo, Jung-Wan;Lee, Seung Jun;Cho, Yu Ji;Jeong, Yi Yeong;Lee, Jong Deog;Kim, Ju-young;Lee, Gi Dong;Kim, Ho Cheol
    • Tuberculosis and Respiratory Diseases
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    • v.81 no.4
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    • pp.311-318
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    • 2018
  • Background: The aim of this study was to examine the influence of body mass index (BMI) on the development of acute kidney injury (AKI) in critically ill patients in intensive care unit (ICU). Methods: Data of patients admitted to medical ICU from December 2011 to May 2014 were retrospectively analyzed. Patients were classified into three groups according to their BMI: underweight (< $18.5kg/m^2$), normal ($18.5-24.9kg/m^2$), and overweight (${\geq}25kg/m^2$). The incidence of AKI was compared among these groups and factors associated with the development of AKI were analyzed. AKI was defined according to the Risk, Injury, Failure, Loss of kidney function, and End-stage (RIFLE) kidney disease criteria. Results: A total of 468 patients were analyzed. Their mean BMI was $21.5{\pm}3.9kg/m^2$, including 102 (21.8%) underweight, 286 (61.1%) normal-weight, and 80 (17.1%) overweight patients. Overall, AKI occurred in 82 (17.5%) patients. The overweight group had significantly (p<0.001) higher incidence of AKI (36.3%) than the underweight (9.8%) or normal group (15.0%). In addition, BMI was significantly higher in patients with AKI than that in those without AKI ($23.4{\pm}4.2$ vs. $21.1{\pm}3.7$, p<0.001). Multivariate analysis showed that BMI was significantly associated with the development of AKI (odds ratio, 1.893; 95% confidence interval, 1.224-2.927). Conclusion: BMI may be associated with the development of AKI in critically ill patients.

Reliability Analysis Method for Concrete Containment Structures (콘크리트 차폐(遮蔽) 구조물(構造物)의 신뢰성(信賴性) 해석방법(解析方法))

  • Han, Bong Koo;Chang, Sung Pil
    • KSCE Journal of Civil and Environmental Engineering Research
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    • v.10 no.1
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    • pp.9-16
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    • 1990
  • The safety of concrete nuclear containment structures should be secured against all kinds of loading due to various natural disasters or extraordinary accidental loads. The current design criteria of concrete containment structures are not based on the reliabillty-based design concept but rely on the conventional design concept. In this paper, a probabillty-based reliability analysis were proposed based on a FEM-based random vibration analysis and serviceability limit state of structures. The limit state model defined for the study is a serviceability limit state in terms of the more realistic crack failure that might cause the emission of radioactive materials, and the results are compared with those of the strength limit state. More accurate reliability analyses under various dynamic loads such as earthquake loads were made possible by incorporation the FEM and random vibration theory, which is different from the conventional reliability analysis method. The uncertainties in loads and resistance available in Korea and the refernces were adapted to the situation of Korea, and especially in the case of earthquake, the design earthquake was assessed based on the available re ports on probabilistic description of earthquake ground acceleration in the Korea peninsula.

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