• Title/Summary/Keyword: Performance confidence

Search Result 1,108, Processing Time 0.032 seconds

Bioequivalence of LANIDIEM® Tablet 4 mg to Vaxar® Tablet 4 mg(Lacidipine 4 mg) (박사르®정 4 밀리그램(라시디핀 4 mg)에 대한 라니디엠®정 4 밀리그램의 생물학적동등성)

  • Lee, Yun-Young;Kim, Hye-Jin;La, Sookie;Cho, Kyung-Hee;Jang, Moon-Sun;Park, Young-Joon;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
    • /
    • v.40 no.2
    • /
    • pp.125-131
    • /
    • 2010
  • A bioequivalence study of LANIDIEM$^{(R)}$ tablet 4 mg (Samil. Co., Ltd.) to Vaxar$^{(R)}$ tablet 4 mg (GlaxoSmithKline Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Forty healthy male Korean volunteers were enrolled in the study and thirty six volunteers completed the study according to the protocol. Thirty six volunteers received each medicine at the lacidipine dose of 4 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of lacidipine were monitored by a high performance liquid chromatography - tandem mass spectrometry (LC-MS/MS) for over a period of 24 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for LANIDIEM$^{(R)}$/Vaxar$^{(R)}$ were log 0.8102~log 1.0417 and log 0.8493~log 1.1439, respectively. These values were within the acceptable bioequivalence intervals of log 0.80~log 1.25. Thus, our study demonstrated the bioequivalence of LANIDIEM$^{(R)}$ tablet 4 mg and Vaxar$^{(R)}$ tablet 4 mg with respect to the rate and extent of absorption.

A Study on the Properties of Foamed Concrete with Plaster Using the Experimental Design (실험계획법을 이용한 석고 혼입 기포콘크리트의 특성에 관한 연구)

  • Lee, Sang-An;Kim, Wha-Jung;Yoon, Sang-Chun
    • Journal of the Korea institute for structural maintenance and inspection
    • /
    • v.17 no.6
    • /
    • pp.130-137
    • /
    • 2013
  • This research was performed through the experimental design to get the statistical analysis on foamed concrete mixed plaster with hydrogen peroxide. In this experiment, we set the ratio of each material, which part of lightweight concrete, as experimental factors and evaluated on the mechanical properties by statistical analysis for response variables obtained from experiments. Experimental factors are plaster replacement, water binder ratio, and hydrogen peroxide ratio. Response variables are dry density, compressive strength, and flexural strength. Mixing design of the foamed concrete set up a total of 15 experimental points by Box-Behnken (BB) method of the response surface analysis. Thus, the results of a study were summarized as follows. Values of the probability in experimental factors (plaster replacement, water binder ratio and hydrogen peroxide ratio) on the response variables were estimated to be significant at the 95% of confidence limit. On response surface analysis for dry density of foamed concrete, water binder ratio and hydrogen peroxide ratio were estimated to be significant (${\alpha}$ = 0.05), and the relationship between the amount of void and the water content for dry density is inverse proportional. On response surface analysis for the compressive strength of foamed concrete, water binder ratio, hydrogen peroxide ratio and (hydrogen peroxide ratio)$^2$ was estimated to be significant (${\alpha}$ = 0.05). On response surface analysis for the flexural strength of foamed concrete, water binder ratio, hydrogen peroxide ratio was estimated to be significant (${\alpha}$ = 0.05). Through multi response surface analysis, we found the optimal area that meets performance goals.

Effects of Students' Collaborative Writing Activities in Elementary Mathematics (초등수학에서 상호글쓰기 활동의 효과 분석)

  • Lee, Sun-Myung;Choi, Chang-Woo
    • Journal of Elementary Mathematics Education in Korea
    • /
    • v.15 no.1
    • /
    • pp.57-75
    • /
    • 2011
  • This research aimed to explore the effects of collaborative writing activities in a mathematical context, specifically pertaining to areas such as numbers and operation, geometrical figure, and measurement in Mathematics: Level 5-b, on their mathematical achievement gain and disposition among Grade 5 students. To do this, out of a total of 62 students selected from two Grade 5 classes of J Elementary School in Dalseo-gu, Daegu City, who were found to be homogenic from the tests of math performance and dispositions, an experimental group(n=31) was designed and compared to a control group (n=31). Over a six week period from October to November in 2009, the experimental group was given collaborative writing lessons in math classes while the control group was given teacher-oriented regular lessons. The results were as follows. First, there was more or less considerable, though not significant, difference in overall mathematical achievement in the students experiencing collaborative writing activities when compared with the students in the control group. However, in terms of numbers and operation, a sub-category of mathematics, there was significant difference between the two groups. Second, the students experiencing collaborative writing activities were more positively affected in all sub-categories of mathematical disposition: confidence, flexibility, determination, curiosity, reflection, and value, than those in the control group. In summing up, the exposure of collaborative writing activities to mathematics learning was found to help students not only to have a concrete and proper grasp of the relevant problem solving process, which was observed from their mathematical achievement gain especially in the sphere of numbers and operation, but also to have their mathematical disposition set towards more positive direction, which was seen in all sub-categories of mathematical disposition measurement.

  • PDF

Evaluation of the clinical efficacy of a TW3-based fully automated bone age assessment system using deep neural networks

  • Shin, Nan-Young;Lee, Byoung-Dai;Kang, Ju-Hee;Kim, Hye-Rin;Oh, Dong Hyo;Lee, Byung Il;Kim, Sung Hyun;Lee, Mu Sook;Heo, Min-Suk
    • Imaging Science in Dentistry
    • /
    • v.50 no.3
    • /
    • pp.237-243
    • /
    • 2020
  • Purpose: The aim of this study was to evaluate the clinical efficacy of a Tanner-Whitehouse 3 (TW3)-based fully automated bone age assessment system on hand-wrist radiographs of Korean children and adolescents. Materials and Methods: Hand-wrist radiographs of 80 subjects (40 boys and 40 girls, 7-15 years of age) were collected. The clinical efficacy was evaluated by comparing the bone ages that were determined using the system with those from the reference standard produced by 2 oral and maxillofacial radiologists. Comparisons were conducted using the paired t-test and simple regression analysis. Results: The bone ages estimated with this bone age assessment system were not significantly different from those obtained with the reference standard (P>0.05) and satisfied the equivalence criterion of 0.6 years within the 95% confidence interval (-0.07 to 0.22), demonstrating excellent performance of the system. Similarly, in the comparisons of gender subgroups, no significant difference in bone age between the values produced by the system and the reference standard was observed (P>0.05 for both boys and girls). The determination coefficients obtained via regression analysis were 0.962, 0.945, and 0.952 for boys, girls, and overall, respectively (P=0.000); hence, the radiologist-determined bone ages and the system-determined bone ages were strongly correlated. Conclusion: This TW3-based system can be effectively used for bone age assessment based on hand-wrist radiographs of Korean children and adolescents.

Generator of Dynamic User Profiles Based on Web Usage Mining (웹 사용 정보 마이닝 기반의 동적 사용자 프로파일 생성)

  • An, Kye-Sun;Go, Se-Jin;Jiong, Jun;Rhee, Phill-Kyu
    • The KIPS Transactions:PartB
    • /
    • v.9B no.4
    • /
    • pp.389-390
    • /
    • 2002
  • It is important that acquire information about if customer has some habit in electronic commerce application of internet base that led in recommendation service for customer in dynamic web contents supply. Collaborative filtering that has been used as a standard approach to Web personalization can not get rapidly user's preference change due to static user profiles and has shortcomings such as reliance on user ratings, lack of scalability, and poor performance in the high-dimensional data. In order to overcome this drawbacks, Web usage mining has been prevalent. Web usage mining is a technique that discovers patterns from We usage data logged to server. Specially. a technique that discovers Web usage patterns and clusters patterns is used. However, the discovery of patterns using Afriori algorithm creates many useless patterns. In this paper, the enhanced method for the construction of dynamic user profiles using validated Web usage patterns is proposed. First, to discover patterns Apriori is used and in order to create clusters for user profiles, ARHP algorithm is chosen. Before creating clusters using discovered patterns, validation that removes useless patterns by Dempster-Shafer theory is performed. And user profiles are created dynamically based on current user sessions for Web personalization.

Bioequivalence of RoxithrinTM Tablet to RulidTM Tablet (Roxithromycin 150 mg) (루리드 정(록시스로마이신 150 mg)에 대한 록시스린 정의 생물학적동등성)

  • Joung, Sun-Koung;Lee, Yun-Young;Cho, Tae-Seob;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
    • /
    • v.34 no.3
    • /
    • pp.209-214
    • /
    • 2004
  • A bioequivalence study of $Roxithrin^{TM}$ tablet (Kukje Pharma. Ind. Co., Ltd.) to $Rulid^{TM}$ tablet (Han Dok Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the roxithromycin dose of 300 mg in a $2{\times}2$ crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography for over a period of 36 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 36 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Roxithrin^{TM}/Rulid^{TM}$ were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of $Roxithrin^{TM}$ and $Rulid^{TM}$ with respect to the rate and extent of absorption.

Pharmacokinetic and Bioequivalence Study of Zolpidem Tartate in Healthy Volunteers

  • Park, Jun-Sung;Myung, Ja-Hye;Wang, Hun-Sik;Koo, Ja-Seong;Cho, Won-Kyung;Cha, Kwang-Ho;Park, Hee-Jun;Kim, Min-So;Kim, Jeong-Soo;Hwang, Sung-Joo
    • Journal of Pharmaceutical Investigation
    • /
    • v.41 no.3
    • /
    • pp.191-196
    • /
    • 2011
  • In this study simple and sensitive high performance liquid chromatographic method using a commercially available column, was developed and validated for the determination of zolpidem tartrate in human plasma. The developed method with suitable validation was applied to a bioequivalence study of two different kinds of zolpidem tartrate. Two different formulations containing 10 mg of zolpidem tartate (CAS : 99294-93-6) were compared in 24 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, cross-over design in 24 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 12 h. The mean $AUC_{0-12h}$, $C_{max}$, $T_{max}$ and $T_{1/2}$ were $676.6{\pm}223.4$ $ng{\cdot}h{\cdot}mL^{-1}$, $177.4{\pm}34.2$ $ng{\cdot}mL^{-1}$, and $0.8{\pm}0.4$ and $3.5{\pm}2.1$, respectively, for the test formulations, and $640.7{\pm}186.6$ $ng{\cdot}h{\cdot}mL^{-1}$, $193.0{\pm}64.5$ $ng{\cdot}mL^{-1}$, and $0.9{\pm}0.4$ and $2.7{\pm}0.9$, respectively, for the reference formulation. Both primary target parameters $AUC_{0-12h}$ and $C_{max}$ were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of $AUC_{0-12h}$ and $C_{max}$ were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of zolpidem tartate are considered to be bioequivalent.

Bioequivalence of Etodin Capsule to Kuhnillodin Capsule (Etodolac 200 mg) (건일로딘 캡슐(에토돌락 200mg)에 대한 에토딘 캡슐의 생물학적동등성)

  • Lee, Myung-Jae;Kang, Jong-Min;Choi, Sang-Jun;Lee, Jin-Sung;Tak, Sung-Kwon;Seo, Ji-Hyung;Rew, Jae-Hwan;Yim, Sung-Vin;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
    • /
    • v.38 no.6
    • /
    • pp.421-427
    • /
    • 2008
  • The purpose of the present study was to evaluate the bioequivalence of two etodolac capsules, Kuhnillodin capsule (Kuhnil. Co., Ltd., Seoul, Korea) as reference drug and Etodin capsule (Myungmun Pharm. Co., Ltd., Seoul, Korea) as test drug, according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-three healthy male Korean volunteers received one capsule at the dose of 200 mg etodolac in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of etodolac were monitored by a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) for over a period of 24 hr after the administration. $AUC_{0-24\;hr}$ was calculated by the linear trapezoidal rule method. $C_{max}$ and $T_{max}$ were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) was carried out using logarithmically transformed $AUC_{0-24\;hr}$ and $C_{max}$. The 90% confidence intervals of the $AUC_{0-24\;hr}$ ratio and the $C_{max}$ ratio for Etodin/Kuhnillodin were $\log\;0.97{\sim}\log\;1.08$ and $\log\;0.89{\sim}\log\;1.19$, respectively. These values were within the acceptable bioequivalence intervals of $\log\;0.80{\sim}\log\;1.25$. Thus, our study demonstrated that Etodin was bioeqiovalent to Kuhnillodin preparation when the rate and extent of absorption between two preparations were compared.

Dissipation characteristics of mandipropamid and thiamethoxam for establishment of pre-harvest residue limits in lettuce (상추의 생산단계 잔류허용기준 설정을 위한 농약 Mandipropamid 및 Thiamethoxam의 잔류소실특성 연구)

  • Yang, Seung-Hyun;Lee, Jae-In;Choi, Hoon
    • Journal of Applied Biological Chemistry
    • /
    • v.63 no.3
    • /
    • pp.267-274
    • /
    • 2020
  • The dissipation characteristics and kinetics of fungicide mandipropamid and insecticide thiamethoxam in lettuce under greenhouse conditions were investigated at three different lettuce-growing fields for estimating the pre-harvest residue limits (PHRLs). The analytical methods were fully validated for the quantitation of pesticide residues using High-Performance Liquid Chromatography-Photo Diode Array detector or Ultraviolet-Visible Detector and applied to real samples. The lettuces suitable for shipment were harvested during 10 days including pre-harvest interval after treatment at the recommended dose by safe-use guidelines. The initial mean residues in different fields were 6.68-17.87 and 4.96-8.31 mg/kg for mandipropamid and thiamethoxam, respectively, which decreased to 16-54 and 14-44% in 10 days. The clothianidin, a metabolite of thiamethoxam, was detected in <0.02 to 0.37 mg/kg. The dissipation of both pesticides followed first-order kinetics over a period of 10 days after application. Based on the residue data, the mean dissipation rate constant (λ) and biological half-lives (T1/2) were estimated to be -0.1060 and 6.5 days of mandipropamid and -0.1236 and 5.6 days of thiamethoxam. The PHRLs for lettuce on the 10th and 5th day before harvesting were calculated to be 63.24 and 43.56 mg/kg for mandipropamid, and 44.66 and 25.88 mg/kg for thiamethoxam, with -0.0746 and -0.1091 of the upper 95% confidence intervals of dissipation rate constant, respectively. This work would be useful as guidance for adjusting the shipment date and contribute to stabilizing the income of farmers in Korea.

Feature-based Non-rigid Registration between Pre- and Post-Contrast Lung CT Images (조영 전후의 폐 CT 영상 정합을 위한 특징 기반의 비강체 정합 기법)

  • Lee, Hyun-Joon;Hong, Young-Taek;Shim, Hack-Joon;Kwon, Dong-Jin;Yun, Il-Dong;Lee, Sang-Uk;Kim, Nam-Kug;Seo, Joon-Beom
    • Journal of Biomedical Engineering Research
    • /
    • v.32 no.3
    • /
    • pp.237-244
    • /
    • 2011
  • In this paper, a feature-based registration technique is proposed for pre-contrast and post-contrast lung CT images. It utilizes three dimensional(3-D) features with their descriptors and estimates feature correspondences by nearest neighborhood matching in the feature space. We design a transformation model between the input image pairs using a free form deformation(FFD) which is based on B-splines. Registration is achieved by minimizing an energy function incorporating the smoothness of FFD and the correspondence information through a non-linear gradient conjugate method. To deal with outliers in feature matching, our energy model integrates a robust estimator which discards outliers effectively by iteratively reducing a radius of confidence in the minimization process. Performance evaluation was carried out in terms of accuracy and efficiency using seven pairs of lung CT images of clinical practice. For a quantitative assessment, a radiologist specialized in thorax manually placed landmarks on each CT image pair. In comparative evaluation to a conventional feature-based registration method, our algorithm showed improved performances in both accuracy and efficiency.