• Title/Summary/Keyword: design rule

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Bioequivalence Evaluation of Two Brands of Zolpidem Tartrate 10 mg Tablets(Zanilo and Stilnox) in Healthy Male Volunteers

  • Ryu, Ju-Hee;Lee, Heon-Woo;Lee, Hyun-Su;Kang, Il-Mo;Seo, Ji-Hyung;Kang, Jin-Yang;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.36 no.5
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    • pp.343-348
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    • 2006
  • The purpose of the present study was to evaluate the bioequivalence of two zolpidem tartrate tablets, Stilnox tablet(Sanofi-aventis Korea, reference product) and Zanilo tablet(ChoDang Pharm Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration(KFDA). After adding an internal standard(cimetropium), 250 ${\mu}L$ plasma samples were extracted using 1.3 mL of ethyl acetate. Extracted compounds were analyzed by HPLC with triple-quadrupole mass spectrometry. This method for determination of zolpidem is proved accurate and reproducible with the limit of quantitation of 1 ng/mL in human plasma. Twenty-four healthy male Korean volunteers received each medicine at the zolpidem tartrate dose of 10 mg in a $2{\times}2$ crossover study. There was one-week washout period between the doses. Plasma concentrations of zolpidem were monitored for over a period of 8 hr after the administration. $AUC_{0-t}$(the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$(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 $AUC_{0-t}$ and $C_{max}$. No significant sequence effect was found for all of the bio-availability parameters indicating that the crossover design was properly performed. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25(e.g., log 0.92-log 1.06 for $AUC_{0-t}$, log 0.96-log 1.13 for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zanilo tablet is bioequivalent to Stilnox tablet.

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
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    • v.34 no.3
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    • pp.209-214
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    • 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.

An Efficient Face Region Detection for Content-based Video Summarization (내용기반 비디오 요약을 위한 효율적인 얼굴 객체 검출)

  • Kim Jong-Sung;Lee Sun-Ta;Baek Joong-Hwan
    • The Journal of Korean Institute of Communications and Information Sciences
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    • v.30 no.7C
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    • pp.675-686
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    • 2005
  • In this paper, we propose an efficient face region detection technique for the content-based video summarization. To segment video, shot changes are detected from a video sequence and key frames are selected from the shots. We select one frame that has the least difference between neighboring frames in each shot. The proposed face detection algorithm detects face region from selected key frames. And then, we provide user with summarized frames included face region that has an important meaning in dramas or movies. Using Bayes classification rule and statistical characteristic of the skin pixels, face regions are detected in the frames. After skin detection, we adopt the projection method to segment an image(frame) into face region and non-face region. The segmented regions are candidates of the face object and they include many false detected regions. So, we design a classifier to minimize false lesion using CART. From SGLD matrices, we extract the textual feature values such as Inertial, Inverse Difference, and Correlation. As a result of our experiment, proposed face detection algorithm shows a good performance for the key frames with a complex and variant background. And our system provides key frames included the face region for user as video summarized information.

Development of Insulation Sheet Materials and Their Sound Characterization

  • Ni, Qing-Qing;Lu, Enjie;Kurahashi, Naoya;Kurashiki, Ken;Kimura, Teruo
    • Advanced Composite Materials
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    • v.17 no.1
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    • pp.25-40
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    • 2008
  • The research and development in soundproof materials for preventing noise have attracted great attention due to their social impact. Noise insulation materials are especially important in the field of soundproofing. Since the insulation ability of most materials follows a mass rule, the heavy weight materials like concrete, lead and steel board are mainly used in the current noise insulation materials. To overcome some weak points in these materials, fiber reinforced composite materials with lightweight and other high performance characteristics are now being used. In this paper, innovative insulation sheet materials with carbon and/or glass fabrics and nano-silica hybrid PU resin are developed. The parameters related to sound performance, such as materials and fabric texture in base fabric, hybrid method of resin, size of silica particle and so on, are investigated. At the same time, the wave analysis code (PZFlex) is used to simulate some of experimental results. As a result, it is found that both bundle density and fabric texture in the base fabrics play an important role on the soundproof performance. Compared with the effect of base fabrics, the transmission loss in sheet materials increased more than 10 dB even though the thickness of the sample was only about 0.7 mm. The results show different values of transmission loss factor when the diameters of silica particles in coating materials changed. It is understood that the effect of the soundproof performance is different due to the change of hybrid method and the size of silica particles. Fillers occupying appropriate positions and with optimum size may achieve a better effect in soundproof performance. The effect of the particle content on the soundproof performance is confirmed, but there is a limit for the addition of the fillers. The optimization of silica content for the improvement of the sound insulation effect is important. It is observed that nano-particles will have better effect on the high soundproof performance. The sound insulation effect has been understood through a comparison between the experimental and analytical results. It is confirmed that the time-domain finite wave analysis (PZFlex) is effective for the prediction and design of soundproof performance materials. Both experimental and analytical results indicate that the developed materials have advantages in lightweight, flexibility, other mechanical properties and excellent soundproof performance.

Evaluation of Yield Load in Pile Load Tests on Driven Piles (관입말뚝에 대한 연직재하시험시 항복하중의 판정법)

  • 홍원표;심기석
    • Geotechnical Engineering
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    • v.5 no.1
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    • pp.7-18
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    • 1989
  • In pile load tests on end bearing piles, generally, it is not possible to continue loading to the ultimate load. Thus, the concept of yield load has been introduced for determining design loads Iron the pile load test records. The conventional rules to determine the yield load were not available for evaluation on pile load test records obtained in 6 fields nearby westers 8r Southern Coasts in Korea. A new rule 9.as presented to determine easily the yield load, based on investigations on the pile load test records. The yield load of piles is determined at the infiection point on semi-logarithmic coordinates (P-logS), in which load is plotted in normal scale and settlement is plotted in logarithmic scale. This method may not only save much costs and times but also present safe luorking circumstances for pile load tests in field. It was found that the yield load represented the elastic limit of the pile load-settlement behalf.iota. The ultimate load, which is given at 25.4mm settlement on pile head, was 1.5 times of the yield load. The allowable long-term and short-term load capacities were, respectively, 50% and 75% of the yield load. The safety factors to get the allowable pile capacity were obtained as 2.0~4.0 for the equations to predict the static pile capacity.

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The Design and Implementation of Access Control framework for Collaborative System (협력시스템에서의 접근제어 프레임워크 설계 및 구현)

  • 정연일;이승룡
    • The Journal of Korean Institute of Communications and Information Sciences
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    • v.27 no.10C
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    • pp.1015-1026
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    • 2002
  • As per increasing research interest in the field of collaborative computing in recent year, the importance of security issues on that area is also incrementally growing. Generally, the persistency of collaborative system is facilitated with conventional authentication and cryptography schemes. It is however, hard to meet the access control requirements of distributed collaborative computing environments by means of merely apply the existing access control mechanisms. The distributed collaborative system must consider the network openness, and various type of subjects and objects while, the existing access control schemes consider only some of the access control elements such as identity, rule, and role. However, this may cause the state of security level alteration phenomenon. In order to handle proper access control in collaborative system, various types of access control elements such as identity, role, group, degree of security, degree of integrity, and permission should be taken into account. Futhermore, if we simply define all the necessary access control elements to implement access control algorithm, then collaborative system consequently should consider too many available objects which in consequence, may lead drastic degradation of system performance. In order to improve the state problems, we propose a novel access control framework that is suitable for the distributed collaborative computing environments. The proposed scheme defines several different types of object elements for the accessed objects and subjects, and use them to implement access control which allows us to guarantee more solid access control. Futhermore, the objects are distinguished by three categories based on the characteristics of the object elements, and the proposed algorithm is implemented by the classified objects which lead to improve the systems' performance. Also, the proposed method can support scalability compared to the conventional one. Our simulation study shows that the performance results are almost similar to the two cases; one for the collaborative system has the proposed access control scheme, and the other for it has not.

Bioequivalence of EtodolTM Tablet to KuhnillodineTM Tablet (Micronized Etodolac 200 mg) (건일로딘 정(미결정에토돌락 200 mg)에 대한 에토돌 정의 생물학적동등성)

  • Lee, Jung-Ae;Lee, Yun-Young;Cho, Tae-Seob;Park, Young-Joon;Moon, Byoung-Seok;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.4
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    • pp.319-325
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    • 2004
  • A bioequivalence of $Etodol^{TM}$ tablets (Yuhan corporation) and $Kuhnillodine^{TM}$ tablets (Kuhnil Pharm. Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 mg dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2{\times}2$ crossover design. Concentrations of etodolac in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (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 performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Etodol^{TM}/Kuhnillodine^{TM}$ were 1.01-1.10 and 0.87-1.06, respectively. This study demonstrated a bioequivalence of $Etodol^{TM}$ and $Kuhnillodine^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of BestidineTM Tablet to Dong-A GasterTM Tablet (Famotidine 20 mg) (동아가스터 정(파모티딘 20 mg)에 대한 베스티딘 정의 생물학적동등성)

  • Park, Chang-Hun;Joung, Sun-Koung;Choi, Mee-Hee;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.6
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    • pp.505-511
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    • 2004
  • A bioequivalence study of $Bestidine^{TM}$ tablets (Choong Wae Pharma. Corp., Korea) to Dong-A $Gaster^{TM}$ (Dong-A Pharmaceutical Co., Ltd., Korea) tablets was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the famotidine dose of 40 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of famotidine were monitored by a high-performance liquid chromatography for over a period of 12 hours after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 12 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 Cmax ratio for $Bestidine^{TM}/Gaster^{TM}$ were log 0.90-log 1.06 and log 0.98-log 1.20, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Bestidine^{TM}$ and $Gaster^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of Atorva Tablet® to Lipitor Tablet® (Atorvastatin 20 mg) (리피토정® (아토르바스타틴 20 mg)에 대한 아토르바정®의 생물학적동등성)

  • Lim, Hyun-Kyun;Lee, Tae-Ho;Lee, Jae-Hyun;Youm, Jeong-Rok;Song, Jin-Ho;Han, Sang-Beom
    • Journal of Pharmaceutical Investigation
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    • v.38 no.2
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    • pp.135-142
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    • 2008
  • The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor $Tablet^{(R)}$ (Pfizer, reference drug) and Atorva $Tablet^{(R)}$ (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a $2{\times}2$ crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were complied trom 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 Atorva $Tablet^{(R)}$ / Lipitor $Tablet^{(R)}$ were ${\log}\;0.9413{\sim}{\log}\;1.0179$ and ${\log}\;0.831{\sim}{\log}\;1.0569$, respectively. These values were within the acceptable bioequivalence intervals of ${\log}\;0.8{\sim}{\log}\;1.25$. Based on these statistical considerations, it was concluded that the test drug, Atorva $Tablet^{(R)}$ was bioequivalent to the reference drug, Lipitor $Tablet^{(R)}$.

The Design and Implementation of Ontology for Simulation based Architecture Framework (ONT-AF) in Military Domain (SBA AF의 구축을 지원하는 온톨로지의 설계 및 구현(ONT-SAF))

  • Kwon, Youngmin;Sohn, Mye;Lee, Wookey
    • Journal of Information Technology and Architecture
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    • v.9 no.3
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    • pp.233-241
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    • 2012
  • Architecture framework (AF) is a guideline to define components needed to develop and operate enterprise architecture (EA), and to define relationships among the components. There are many architecture frameworks to operate EA of governments and businesses such as Zachman framework, DoDAF, TOGAF, FEAF, and TEAF. DoDAF is the most representative AF to support the development of the EA in the military domain. DoDAF is composed of eight viewpoints and 40 views that are affiliated with the viewpoints. To develop an AF for a specific goal, system architects decide a set of views. Furthermore, they determine data that are needed for a view modeling. However, views and data in DoDAF are structurally inter-related explicitly and/or implicitly. So, developing an AF for a specific goal is going to be a project to be carried out over a long haul. To reduce the burden of its development, in this paper, we develop ONT-SAF (Ontology for DoDAF) that can infer inter-relationships like referential and transitive relationships and the sequences among the views. Furthermore, to promote reusability and consistency of the views and the data within an AF, we adopt the view-data separation strategy. ONT-DAT contains classes like 'viewpoint', 'view', 'data', 'expression method', and 'reference model', and 11 properties including 'hasView.' To prove the effectiveness of ONT-SAF, we perform a case study.