• Title/Summary/Keyword: design rule

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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
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    • v.40 no.2
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    • pp.125-131
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    • 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.

Bioequivalence of Cholicerin Soft Capsule to Gliatilin Soft Capsule (Choline Alphoscerate 400 mg)

  • Kang, Hyun-Ah;Kim, Se-Mi;Kang, Seung-Rae;Kang, Min-Sun;Lee, Sang-No;Kwon, In-Ho;Yoo, Hee-Doo;Kim, Yoon-Gyoon;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.40 no.2
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    • pp.109-115
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    • 2010
  • The purpose of the present study was to evaluate the bioequivalence of two choline alphoscerate soft capsules, Gliatilin soft capsule (Daewoong Pharmaceuticals Co., Ltd.) and Cholicerin soft capsule (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Serum concentrations of choline after oral administration of choline alphoscerate were determined using a validated LC/MS/MS method. This method showed linear response over the concentration range of 0.5-20 ${\mu}g$/mL with correlation coefficient of 0.9999. The lower limit of quantitation using 100 ${\mu}L$ of serum was 0.5 ${\mu}g$/mL which was sensitive enough for pharmacokinetic studies. Thirty six healthy male Korean volunteers received each medicine at the choline alphoscerate dose of 1200 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Blood samples were taken at predetermined time intervals up to 8 hr. $AUC_t$ (the area under the serum concentration-time curve from time 0 to 8 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (the maximum serum drug concentration) and $T_{max}$ (the time to reach $C_{max}$) were compiled from the serum 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 Cholicerin/Gliatilin were log0.9998-log1.1172 and log0.9938-1.0944, respectively. These values were within the acceptable bioequivalence intervals of log0.80-log1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Cholicerin soft capsule and Gliatilin soft capsule are bioequivalent.

Study of the Dormitory Architecture of Governmental Secondary Schools in the Japanese Colonial Era (일제 강점기 관립 중등학교 기숙사 건축에 관한 연구)

  • Lee, Jeong-Woo
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.15 no.8
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    • pp.5355-5362
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    • 2014
  • This study reviewed the planning characteristics of dormitories for secondary schools in the Japanese Colonial Era by analyzing the architectural drawings collected by the National Archives of Korea. The dormitory was one of the essential facilities in secondary schools but there have been few studies in this area. The analysis items were the site plan and the planning characteristics of student bedrooms, dining hall, and supervisor's area, which were the main elements of the dormitory. The results of this study were summarized as follows. 1) Generally, the dormitory area was placed in the rear of buildings for teaching with a close connection. 2) The student bedroom wings were laid out in parallel to the south as a rule making the typical site plan pattern for a dormitory, whereas the other parts of dormitory, such as the dining hall and supervisor's area were placed in the site conditions. 3) Generally, the unit plans of bedrooms for Korean schools were the ondol type and were small in size, whereas those for Japanese were the tatami type and large in size with separate study and sleeping areas. 4) The dining hall annex was made up of a dining hall and kitchen-bathroom area in general. For Japanese schools, the school store area was added to these areas. The typical shapes of dining hall plans were narrow and long with an adjacent corridor, so the overall plan of the dining hall annex was like that of a single-corridor type block plan. 5) The supervisor's area was a smaller part of the dormitory but it was considered to be a symbolic part of the whole dormitory in site planning and design.

Assessment of Fatigue Life of Out-Of-Plane Gusset Welded Joints using 3D Crack Propagation Analysis (3차원 피로균열 진전해석을 통한 면외거셋 용접이음의 피로수명 평가)

  • Jeong, Young-Soo;Kainuma, Shigenobu;Ahn, Jin-Hee;Lee, Wong-Hong
    • Journal of the Korea institute for structural maintenance and inspection
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    • v.22 no.1
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    • pp.129-136
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    • 2018
  • The estimation of the fatigue design life for large welded structures is usually performed using the liner cumulative damage method such as Palmgren-Miner rule or the equivalent damage method. When a fatigue crack is detected in a welded steel structure, the residual service life has to be estimated base on S-N curve method and liner elastic fracture mechanics. In this study, to examine the 3D fatigue crack behavior and estimate the fatigue life of out-of-plane gusset fillet welded joint, the fatigue tests were carried out on the model specimens. Investigations of three-dimensional fatigue crack propagation on gusset welded joint was used the finite element analysis of FEMAP with NX NASTRAN and FRANC3D. Fatigue crack growth analysis was carried out to demonstrate the effects of aspect ratio, initial crack length and stress ratio on out-of-plane gusset welded joints. In addition, the crack behaviors of fatigue tests were compared with those of the 3D crack propagation analysis in terms of changes in crack length and aspect ratio. From this analysis result, SIFs behaviors and crack propagation rate of gusset welded joint were shown to be similar fatigue test results and the fatigue life can also be predicted.

Frame Synchronization Algorithm based on Differential Correlation for Burst OFDM System (Burst OFDM 시스템을 위한 차동 상관 기반의 프레임 동기 알고리즘)

  • Um Jung-Sun;Do Joo-Hyun;Kim Min-Gu;Choi Hyung-Jin
    • The Journal of Korean Institute of Communications and Information Sciences
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    • v.30 no.10C
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    • pp.1017-1026
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    • 2005
  • In burst OFDM system, the frame synchronization should be performed first for the acquisition of received frame and the estimation of the correct FFT-window position. The conventional frame synchronization algorithms using design features of the preamble symbol, the repetition pattern of the OFDM symbol by pilot sub-carrier allocation rule and Cyclic Prefix(CP), has difficulty in the detection of precise frame timing because its correlation characteristics would increase and decrease gradually. Also, the algorithm based on the correlation between the reference signal and the received signal has performance degradation due to frequency offset. Therefore, we adopt a differential correlation method that is robust to frequency offset and has the clear peak value at the correct frame timing for frame synchronization. However, performance improvement is essential for differential correlation methods, since it usually shows multiple peak values due to the repetition pattern. In this paper, we propose an enhanced frame synchronization algorithm based on the differential correlation method that shows a clear single peak value by using differential correlation between samples of identical repeating pattern. We also introduce a normalization scheme which normalizes the result of differential correlation with signal power to reduce the frame timing error in the high speed mobile channel environments.

Design and frnplernentation of a Query Processing Algorithm for Dtstributed Semistructlred Documents Retrieval with Metadata hterface (메타데이타 인터페이스를 이용한 분산된 반구조적 문서 검색을 위한 질의처리 알고리즘 설계 및 구현)

  • Choe Cuija;Nam Young-Kwang
    • Journal of KIISE:Software and Applications
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    • v.32 no.6
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    • pp.554-569
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    • 2005
  • In the semistructured distributed documents, it is very difficult to formalize and implement the query processing system due to the lack of structure and rule of the data. In order to precisely retrieve and process the heterogeneous semistructured documents, it is required to handle multiple mappings such as 1:1, 1:W and W:1 on an element simultaneously and to generate the schema from the distributed documents. In this paper, we have proposed an query processing algorithm for querying and answering on the heterogeneous semistructured data or documents over distributed systems and implemented with a metadata interface. The algorithm for generating local queries from the global query consists of mapping between g1oba1 and local nodes, data transformation according to the mapping types, path substitution, and resolving the heterogeneity among nodes on a global input query with metadata information. The mapping, transformation, and path substitution algorithms between the global schema and the local schemas have been implemented the metadata interface called DBXMI (for Distributed Documents XML Metadata Interface). The nodes with the same node name and different mapping or meanings is resolved by automatically extracting node identification information from the local schema automatically. The system uses Quilt as its XML query language. An experiment testing is reported over 3 different OEM model semistructured restaurant documents. The prototype system is developed under Windows system with Java and JavaCC compiler.

A Study on the Characteristics of the Korean Adult Male Sound According to Sasang Constitution Using PSCC with a Sentence (사상체질음성분석기(四象體質音聲分析機)(PSSC)를 통한 한국인 성인남성(成人男性)의 체질별(體質別) 음향특성연구(音響特性硏究) - 단문(短文)을 중심으로 -)

  • Choi, Jae-Wan;Song, Hak-Soo;Han, Dong-Youn;Cho, Sung-Eon;Wang, Hyang-Lan;Jeon, Jong-Weon;Kim, Dal-Rae;Yoo, Jun-Sang
    • Journal of Sasang Constitutional Medicine
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    • v.18 no.3
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    • pp.64-74
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    • 2006
  • 1. Objectives and Methods A Study on the Characteristics of the Korean Adult Male Sound according to Sasang Constitution using PSSC with a Sentence. Sasang Constitutional Medicine(SCM) is the one of the traditional Korean Medicine. It classifies people into four categories like Taeyangin, Soyangin, Taeumin and Soeumin. The rule to classify is Appearance and Body Shape, Facial Appearance and Speech, Character and Talents and Diseases and Medications. This study was done to investigate the relationships between Voice and Sound parameters using PSSC(Phonetic System of Sasang Constitution) in a sentence. Experimental Participants were 195 Korean adult males including 1 Taeyangin, 37 Soyangin, 105 Taeumin and 52 Soeumin. Sasang Constitutional specialist used PSSC and Korean Medical Diagnosis to classify participants into four constitution. 2. Results In Pitch segment, Soyangin's Center freq.(4) was significantly high compared with Taeyangin and Taeumin groups. Soyangin's and Soeumin's Center freq.(6) was significantly high compared with Taeyangin and Taeumin groups. In APQ segment and Octave segment, there were no significant differences among four groups. In Shimmer segment, Taeumin's F Shimmer(1) and F Shimmer(2) were significantly high compared with Taeyangin and Soyangin groups. In Energy segment, Taeyangin's 2k-4k total sum, 2k-4k dev., C dev., C# dev. and D S.D. were significantly high compared with other groups. In Recording time segment, there was no significant difference among four groups. More Taeyangin cases and the other parameters are needed to determine constitution using PSSC and to make PSSC effective. 3. Conclusions From above result, there is the possibility of efficiency standard guide for constitution diagnosis by analyzation og voice.

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John Dewey's Theory of Criticism (존 듀이의 비평 이론)

  • Kim Jin-Yup
    • Journal of Science of Art and Design
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    • v.2
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    • pp.222-238
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    • 2000
  • The attempts to explain the criterion of art criticism can be divided into three directions. The first is that there is a universal criterion of criticism. The second is that criticism is a subjective impression of each critic. Therefore, there is no universal criterion beyond a subjective impression. The third is that denies both claims. It tries to and the objective criterion which is neither universal nor subjective. In this paper, I will see how John Dewey criticizes the first two theories and holds the third theory. Dewey's denial of the first theory can be seen in his view of the judical criticism. The judical criticism claims that art criticism can be made on the universal criterion, as judical decision can be made on the general rule supposed to be applicable to all cases. But Dewey claims that the judical criticism cannot explain what makes the artist the 'masters'. Defining art as an experience, Dewey claims that art is a process of doing and undergoing, and that art is essentially an interactive activity between men and his environment As environment changes, the experience of the environment also changes. So art should accept the possibility of new experience. But, since the judical criticism advocates of the universal criterion which cannot allow the changeability, Dewey denies it. On the other hand, Dewey's denial of the second theory can be seen in his view of the impressionist criticism. The impressionist criticism claims that criticism is to clarify the impression which is consisted of feeling and imagery the art object evokes. To this claim, Dewey replies that to clarify an impression is to analyze it, and analysis can proceed only by going beyond the impression to the judgement. As we have seen so far, Dewey has denied the judical criticism that there is a universal criterion supposed to be applicable to all criticism. He has also denied the impressionist criticism that there are only subjective responses to the art object, and hence that there is no criterion of criticism at all. For Dewey, these two criticism are based on the same false assumption of the criterion, although their conclusions are different from each other. Both the judical and impressionist criticism failed to realize the difference between the meaning of the criterion as applied in measurement and as used in criticism. Criticizing of these two views of criticism, Dewey claims that there is an objective criterion which is neither universal nor subjective. Art criticism is objective in tv#o senses, i. e., in the first sense that it can be judged by the properties of the art object and in the second sense that it can be verified by the communities of the critics.

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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.