• 제목/요약/키워드: Confidence Evaluation

검색결과 795건 처리시간 0.025초

동화약품 시사프리드제제의 생물학적 동등성 평가 (Bioequivalence Evaluation of the Cisapride Formulation Produced by Dong Wha Pharmaceutical Co.)

  • 윤광희;박진영;박선주;조은희;유제만;김경식;정석재;이민화;심창구
    • Biomolecules & Therapeutics
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    • 제7권1호
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    • pp.59-65
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    • 1999
  • A bioequivalence study of the Dong Wha Cisapril tablets(Dong Wha Pharm. Ind. Co., Ltd.) to the Prepulsid tablets(Janssen Korea Ltd.), formulations of cisapride, was conducted. Twenty four healthy Korean male subjects received each formulation at the dose of 5 mg as cisapride in a 2$\times$2 crossover study. There was a 1-week washout period between the doses. Plasma concentrations of cisapride were monitored by an LC/MS method for over a period of 36 h after each administration. AUC(area under the plasma concentration- time curve from time zero to infinity) was calculated by the linear trapezoidal and extrapolation method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, $C_{max}$ and $T_{max}$ between the formulations. The apparent differences between the formulations in these parameters were all far less than 20% (i.e., 6.8, -6.6 and 1.8% for AUC, $C_{max}$ and $T_{max}$, respectively). Minimum detectable differences(%) at $\alpha$=0.05 and 1-$\beta$=0.8 were all less than 20% in these parameters between the formulations (i.e., 16.5, 11.4 and 16.4% for AUC, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within 20% (i.e., -2.9~ 16.4, -13.2~0.1 and -7.8~ 11.4% for AUC, $C_{max}$ and $T_{max}$, respectively). These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 98-51). Therefore, these results indicate that the two formulations of cisapride are bioequivalent and, thus, may be prescribed interchangeably.hangeably.y.hangeably.

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Inter- and Intra-Observer Variability of the Volume of Cervical Ossification of the Posterior Longitudinal Ligament Using Medical Image Processing Software

  • Shin, Dong Ah;Ji, Gyu Yeul;Oh, Chang Hyun;Kim, Keung Nyun;Yoon, Do Heum;Shin, Hyunchul
    • Journal of Korean Neurosurgical Society
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    • 제60권4호
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    • pp.441-447
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    • 2017
  • Objective : Computed tomography (CT)-based method of three dimensional (3D) analysis ($MIMICS^{(R)}$, Materialise, Leuven, Belgium) is reported as very useful software for evaluation of OPLL, but its reliability and reproducibility are obscure. This study was conducted to evaluate the accuracy of $MIMICS^{(R)}$ system, and inter- and intra-observer reliability in the measurement of OPLL. Methods : Three neurosurgeons independently analyzed the randomly selected 10 OPLL cases with medical image processing software ($MIMICS^{(R)}$) which create 3D model with Digital Imaging and Communication in Medicine (DICOM) data from CT images after brief explanation was given to examiners before the image construction steps. To assess the reliability of inter- and intra-examiner intraclass correlation coefficient (ICC), 3 examiners measured 4 parameters (volume, length, width, and length) in 10 cases 2 times with 1-week interval. Results : The inter-examiner ICCs among 3 examiners were 0.996 (95% confidence interval [CI], 0.987-0.999) for volume measurement, 0.973 (95% CI, 0.907-0.978) for thickness, 0.969 (95% CI, 0.895-0.993) for width, and 0.995 (95% CI, 0.983-0.999) for length. The intra-examiner ICCs were 0.994 (range, 0.991-0.996) for volume, 0.996 (range, 0.944-0.998) for length, 0.930 (range, 0.873-0.947) for width, and 0.987 (range, 0.985-0.995) for length. Conclusion : The medical image processing software ($MIMICS^{(R)}$) provided detailed quantification OPLL volume with minimal error of inter- and intra-observer reliability in the measurement of OPLL.

가속노화 시험을 통한 진공단열패널(VIP)의 장기성능 평가 연구 (The Study of Long-Term Performance Evaluation of Vacuum Insulation Panel(VIP) with Accelerated Aging Test)

  • 김진희;김준태
    • 한국태양에너지학회 논문집
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    • 제37권4호
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    • pp.35-47
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    • 2017
  • Energy efficiency solutions are being pursued as a sustainable approach to reducing energy consumption and related gas emissions across various sectors of the economy. Vacuum Insulation Panel (VIP) is an energy efficient advanced insulation system that facilitates slim but high-performance insulation, based on a porous core material evacuated and encapsulated in a barrier envelope. Although VIP has been applied in buildings for over a decade, it wasn't until recently that efforts have been initiated to propose and adopt a global standard on characterization and testing of VIP. One of the issues regarding VIP is its durability and aging due to pressure and moisture dependent increase of the initial low thermal conductivity with time; more so in building applications. In this paper, the aging of commercially available VIP was investigated experimentally; thermal conductivity was tested in accordance with ISO 8302 standard (guarded hot box method) and long-term durability was estimated based on a non-linear pressure-humidity dependent equation based on study of IEA/ECBCS Annex 39, with the aim of assessing durability of VIP for use in buildings. The center-of-panel thermal conductivity after 25 years based on initial 90% fractile with a confidence level of 90 % for the thermal conductivity (${\lambda}90/90$) ranged from 0.00726-0.00814 (W/m K) for silica core VIP. Significant differences between manufacturer-provided data and measurements of thermal conductivity and internal pressure were observed.

BTEX 분석용 토양 숙련도 표준시료(PTMs) 개발에 관한 연구 (A Study on the Development of Soil-based PTMs for Analysis of BTEX)

  • 이민효;이군택;이법열;이원석;김금희;홍석영
    • 한국지하수토양환경학회지:지하수토양환경
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    • 제18권5호
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    • pp.15-25
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    • 2013
  • In this study, two kinds of soil-based proficiency testing materials (PTMs), NICE-012L and NICE-012R were prepared and certified for Benzen, Toluene, Etylbenzene and Xylene with evaluation of uncertainties. In order to analyse BTEX (Benzen Toluene Etylbenzene Xylene) for the candidate materials, GC/MS was used after pretreatment according to methods of soil analysis by Ministry of Environment. For the homogeneity test among bottles in terms of candidate materials, ISO 13528 and IUPAC Protocol were used and according to the result, both candidate materials showed sufficient homogeneity. Also, the stability test over the candidate materials was accessed according to the ISO Guide 35 by classifying short-term and long-term stability and the result showed that both candidate materials showed decent stability. The reference values of the two candidate materials depending on BTEX components were derived from the average of the 11 samples that were used for verification of the samples' homogeneity. Uncertainty of measurement was combined by uchar that was caused by a characteristic value, $u_{bb}$ that was caused by between-bottle homogeneity, and $u_{stab}$ that was caused by stability, and then combined uncertainty ($u_{PTM}$) was multiplied to the coverage factor (k) derived from the effective degree of freedom from each factor that leads to expanded uncertainty (U) in about 95% of confidence level. The proficiency testing materials developed through this study were supplied to National Institute of Environmental Research (NIER) and utilized as an external proficiency testing materials for evaluating analysis capacity of soil agencies with specialty in terms of soil analysis approved by Minister of Environment.

이러닝 교육(인슐린 주사방법)을 통한 신규 간호사 교육 프로그램의 효과 (Effects of a New-Nurse Education Program Utilizing E-learning and Instructor Demonstration on Insulin Injection Practices)

  • 김영미;유명숙;조연희;박승혜;남승남;김민영
    • 임상간호연구
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    • 제17권3호
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    • pp.411-420
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    • 2011
  • Purpose: The purpose of this study was to develop and evaluate a new-nurse education program utilizing both e-learning and instructor demonstration. Methods: From August to December in 2009, the e-learning education program about insulin injection was developed. The control (C) group was educated via instructor demonstration from April 15 to October 6 in 2009, and the experimental (E) group was educated via both e-learning and instructor demonstration from January 5 to October 13 in 2010. After each education, knowledge and educational effectiveness were checked. Results: Satisfaction with the education contents in the E group was significantly higher than those of the C group (Z=-3.72, p<.001), and satisfaction with the education method in the E group was higher than those of the C group (Z=-2.98, p=.003). Usefulness (Z=-3.33, p=.001), application (Z=-2.62, p=.009), and confidence (Z=-2.61, p=.009) in the E group were all higher than those of the C group. 78.9% in the E group reused the e-learning program after the experimental education. Conclusion: Combined educational program with e-learning and instructor demonstration had both merits of online efficiency and face-to-face education. It would be useful especially for new-nurses to improve their nursing skills in accomplishing their roles.

A fully deep learning model for the automatic identification of cephalometric landmarks

  • Kim, Young Hyun;Lee, Chena;Ha, Eun-Gyu;Choi, Yoon Jeong;Han, Sang-Sun
    • Imaging Science in Dentistry
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    • 제51권3호
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    • pp.299-306
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    • 2021
  • Purpose: This study aimed to propose a fully automatic landmark identification model based on a deep learning algorithm using real clinical data and to verify its accuracy considering inter-examiner variability. Materials and Methods: In total, 950 lateral cephalometric images from Yonsei Dental Hospital were used. Two calibrated examiners manually identified the 13 most important landmarks to set as references. The proposed deep learning model has a 2-step structure-a region of interest machine and a detection machine-each consisting of 8 convolution layers, 5 pooling layers, and 2 fully connected layers. The distance errors of detection between 2 examiners were used as a clinically acceptable range for performance evaluation. Results: The 13 landmarks were automatically detected using the proposed model. Inter-examiner agreement for all landmarks indicated excellent reliability based on the 95% confidence interval. The average clinically acceptable range for all 13 landmarks was 1.24 mm. The mean radial error between the reference values assigned by 1 expert and the proposed model was 1.84 mm, exhibiting a successful detection rate of 36.1%. The A-point, the incisal tip of the maxillary and mandibular incisors, and ANS showed lower mean radial error than the calibrated expert variability. Conclusion: This experiment demonstrated that the proposed deep learning model can perform fully automatic identification of cephalometric landmarks and achieve better results than examiners for some landmarks. It is meaningful to consider between-examiner variability for clinical applicability when evaluating the performance of deep learning methods in cephalometric landmark identification.

The global prevalence of Toxocara spp. in pediatrics: a systematic review and meta-analysis

  • Abedi, Behnam;Akbari, Mehran;KhodaShenas, Sahar;Tabibzadeh, Alireza;Abedi, Ali;Ghasemikhah, Reza;Soheili, Marzieh;Bayazidi, Shnoo;Moradi, Yousef
    • Clinical and Experimental Pediatrics
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    • 제64권11호
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    • pp.575-581
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    • 2021
  • Background: Toxocariasis is a zoonotic parasitic disease caused by Toxocara canis and Toxocara cati in humans. Various types of T. canis are important. Purpose: The current study aimed to investigate the prevalence of Toxocara spp. in pediatrics in the context of a systematic review and meta-analysis. Methods: The MEDLINE (PubMed), Web of Sciences, Embase, Google Scholar, Scopus, and Cumulative Index of Nursing and Allied Health databases were searched to identify peer-reviewed studies published between January 2000 and December 2019 that report the prevalence of Toxocara spp. in pediatrics. The evaluation of articles based on the inclusion and exclusion criteria was performed by 2 researchers individually. Results: The results of 31 relevant studies indicated that the prevalence of Toxocara spp. was 3%-79% in 10,676 cases. The pooled estimate of global prevalence of Toxocara spp. in pediatrics was 30 (95% confidence interval, 22%-37%; I2=99.11%; P=0.00). The prevalence was higher in Asian populations than in European, American, and African populations. Conclusion: Health policymakers should be more attentive to future research and approaches to Toxocara spp. and other zoonotic diseases to improve culture and identify socioeconomically important factors.

Pregnancy and Neonatal Outcomes of Group B Streptococcus Infection in Preterm Births

  • Lee, Yae Heun;Lee, Yoo Jung;Jung, Sun Young;Kim, Suk Young;Son, Dong Woo;Seo, Il Hye
    • Perinatology
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    • 제29권4호
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    • pp.147-152
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    • 2018
  • Objective: This study examines whether maternal group B Streptococcus (Streptococcus agalactiae, GBS) infection was associated with preterm births and premature neonatal outcomes. Methods: Maternal and neonatal outcomes were examined among singleton pregnant women with preterm birth (from $24^{+0}weeks$ to $36^{+6}weeks$) who were tested for GBS (n=203) during the pregnancy. Data were collected retrospectively from the medical records of women who delivered at our hospital from January 2015 to February 2017. We compared obstetrical factors (causes of preterm birth) and neonatal (gestational age at delivery, birth weight, Apgar score 1 min/5 min, hospitalization period, duration of mechanical ventilation, neonatal C-reactive protein within three days, and other complication [respiratory distress syndrome, neonatal deaths]) outcomes between GBS-infected and non-infected pregnant women. Results: There were 203 singleton pregnant women included in the study, 25 of whom were confirmed to have a GBS infection during the pregnancy. There was no difference in neonatal outcomes by GBS status. Preterm premature rupture of membranes (pPROM), as an obstetric factor, was associated with GBS infection (P=0.022). GBS infection raised the risk of pPROM by 3.6 times (odds ratio 3.648, 95% confidence interval 1.476-9.016, P=0.005). Conclusion: GBS infection in preterm birth was associated with pPROM but did not result in adverse neonatal outcomes. Continuous attention and evaluation of GBS infection, a major cause of neonatal sepsis and pneumonia, are needed.

Functional Prediction of Hypothetical Proteins from Shigella flexneri and Validation of the Predicted Models by Using ROC Curve Analysis

  • Gazi, Md. Amran;Mahmud, Sultan;Fahim, Shah Mohammad;Kibria, Mohammad Golam;Palit, Parag;Islam, Md. Rezaul;Rashid, Humaira;Das, Subhasish;Mahfuz, Mustafa;Ahmeed, Tahmeed
    • Genomics & Informatics
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    • 제16권4호
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    • pp.26.1-26.12
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    • 2018
  • Shigella spp. constitutes some of the key pathogens responsible for the global burden of diarrhoeal disease. With over 164 million reported cases per annum, shigellosis accounts for 1.1 million deaths each year. Majority of these cases occur among the children of the developing nations and the emergence of multi-drug resistance Shigella strains in clinical isolates demands the development of better/new drugs against this pathogen. The genome of Shigella flexneri was extensively analyzed and found 4,362 proteins among which the functions of 674 proteins, termed as hypothetical proteins (HPs) had not been previously elucidated. Amino acid sequences of all these 674 HPs were studied and the functions of a total of 39 HPs have been assigned with high level of confidence. Here we have utilized a combination of the latest versions of databases to assign the precise function of HPs for which no experimental information is available. These HPs were found to belong to various classes of proteins such as enzymes, binding proteins, signal transducers, lipoprotein, transporters, virulence and other proteins. Evaluation of the performance of the various computational tools conducted using receiver operating characteristic curve analysis and a resoundingly high average accuracy of 93.6% were obtained. Our comprehensive analysis will help to gain greater understanding for the development of many novel potential therapeutic interventions to defeat Shigella infection.

Study on Thermal Load Capacity of Transmission Line Based on IEEE Standard

  • Song, Fan;Wang, Yanling;Zhao, Lei;Qin, Kun;Liang, Likai;Yin, Zhijun;Tao, Weihua
    • Journal of Information Processing Systems
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    • 제15권3호
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    • pp.464-477
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    • 2019
  • With the sustained and rapid development of new energy sources, the demand for electric energy is increasing day by day. However, China's energy distribution is not balanced, and the construction of transmission lines is in a serious lag behind the improvement of generating capacity. So there is an urgent need to increase the utilization of transmission capacity. The transmission capacity is mainly limited by the maximum allowable operating temperature of conductor. At present, the evaluation of transmission capacity mostly adopts the static thermal rating (STR) method under severe environment. Dynamic thermal rating (DTR) technique can improve the utilization of transmission capacity to a certain extent. In this paper, the meteorological parameters affecting the conductor temperature are analyzed with the IEEE standard thermal equivalent equation of overhead transmission lines, and the real load capacity of 220 kV transmission line is calculated with 7-year actual meteorological data in Weihai. Finally, the thermal load capacity of DTR relative to STR under given confidence is analyzed. By identifying the key parameters that affect the thermal rating and analyzing the relevant environmental parameters that affect the conductor temperature, this paper provides a theoretical basis for the wind power grid integration and grid intelligence. The results show that the thermal load potential of transmission lines can be effectively excavated by DTR, which provides a theoretical basis for improving the absorptive capacity of power grid.