• Title/Summary/Keyword: design rule

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Bioequivalence of DilastTM Capsule to Ketas® Capsule (Ibudilast 10 mg) (케타스캅셀(이부딜라스트 10 mg)에 대한 딜라스트캡슐의 생물학적동등성)

  • Chang, Kyu-Young;Kang, Seong-Woo;Yoo, Eun-Ju;Lew, Soo-Hyun;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.37 no.3
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    • pp.197-203
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    • 2007
  • A bioequivalence study of $Dilast^{TM}$ Capsule (Chong Kun Dang Pharma. Co., Ltd.) to $Ketas^{(R)}$ Capsule (Han Dok Pharma. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty eight healthy male Korean volunteers received each medicine at the ibudilast dose of 20 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of ibudilast were monitored by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) 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 crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Dilast^{TM}$ $Capsule/Ketas^{(R)}$ Capsule were $log0.93{\sim}log1.06$ and $log0.93{\sim}log1.11$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Thus, our study demonstrated the bioequivalence of $Dilast^{TM}$ Capsule and $Ketas^{(R)}$ Capsule with respect to the rate and extent of absorption.

Effective Measuring Method of Discontinuity Orientation (불연속면 방향의 효율적인 측정 방안)

  • 김해경;고영구
    • The Journal of Engineering Geology
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    • v.13 no.3
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    • pp.321-334
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    • 2003
  • This study is aimed at the effective measurement plan of discontinuity orientation on rock mass. The discontinuity orientation is expressed as three methods. strike/dip. dipdirection/dip (a three digit number / a two digit number) and right hand rule. Generally, strike/dip is measured with clinometer. and dipdirection/dip with silva compass(type15). A sign of strike/dip. discontinuity orientation is used to geological survey. and dipdirection/dip to engineering. Dipdirection/dip converted by strike/dip measured with clinometer is useful on the statistical analysis of a lot of data. To measure the azimuth of the dip with clinometer and to change strike/dip to dipdirection/dip may have potential errors in each person. The newly designed apparatus, clinometer equipped by a rotational azimuth plate and an arrow to measuring strike and dipdirection, has been developed to measure effectively the discontinuity orientation with two method (strike/dip and dipdirection/dip). The measuring method of discontinuity orientation with clinometer having newly designed apparatus is effective one for accurate measurement of strike as well as dipdirection which is degrees counted clockwise from true north. Used by clinometer with newly designed apparatus, concurrent measuring strike/dip and dipdirecton/dip of discontinuity is possible. In application to measuring discontinuity orientation on rock slope, it has been recognized that the newly designed method, unambiguously, led to drop measuring errors comparing with existing measuring apparatuses. Therefore, it is considered that measuring method of discontinuity orientation (strike/dip and dipdirecton/dip) by the newly designed apparatus is useful to one in geological engineering investigation of road design, and to unskilled investigator.

Development of Intelligent Internet Shopping Mall Supporting Tool Based on Software Agents and Knowledge Discovery Technology (소프트웨어 에이전트 및 지식탐사기술 기반 지능형 인터넷 쇼핑몰 지원도구의 개발)

  • 김재경;김우주;조윤호;김제란
    • Journal of Intelligence and Information Systems
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    • v.7 no.2
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    • pp.153-177
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    • 2001
  • Nowadays, product recommendation is one of the important issues regarding both CRM and Internet shopping mall. Generally, a recommendation system tracks past actions of a group of users to make a recommendation to individual members of the group. The computer-mediated marketing and commerce have grown rapidly and thereby automatic recommendation methodologies have got great attentions. But the researches and commercial tools for product recommendation so far, still have many aspects that merit further considerations. To supplement those aspects, we devise a recommendation methodology by which we can get further recommendation effectiveness when applied to Internet shopping mall. The suggested methodology is based on web log information, product taxonomy, association rule mining, and decision tree learning. To implement this we also design and intelligent Internet shopping mall support system based on agent technology and develop it as a prototype system. We applied this methodology and the prototype system to a leading Korean Internet shopping mall and provide some experimental results. Through the experiment, we found that the suggested methodology can perform recommendation tasks both effectively and efficiently in real world problems. Its systematic validity issues are also discussed.

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Bioequivalence of FLUTAL Tablet to SOMALGEN Tablet (Talniflumate 370 mg) (소말겐 정(탈니플루메이트 370 mg)에 대한 플루탈 정의 생물학적동등성)

  • Lee, Heon-Woo;Cho, Sung-Hee;Park, Wan-Su;Im, Ho-Taek;Kim, Young-Kwan;Rew, Jae-Hwan;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.35 no.4
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    • pp.303-308
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    • 2005
  • The purpose of the present study was to evaluate the bioequivalence of two talniflumate tablets, SOMALGEN tablet (Kun Wha Pharm. Co., Ltd., Seoul, Korea, reference drug) and FLUTAL tablet (Kukje Pharm. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets at the talniflumate dose of 740 mg in a $2{\pm}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of niflumic acid were monitored by an HPLC-UV for over a period of 14 hr after the administration. $AUC_t$(the area under the plasma concentration-time curve from time zero to 14 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 $AUC_t$, $C_{max}$ and untransformed $T_{max}$. 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 SOMALGEN/FLUTAL were $log0.8510{\sim}log1.0318$ and $log0.9264{\sim}log1.0607$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Taken together, our study demonstrated the bioequivalence of SOMALGEN and FLUTAL with respect to the rate and extent of absorption.

Bioequivalence Of SudoTM Ranitidine Hydrochloride Tablet to CuranTM Tablet (Ranitidine Hydrochloride 150 mg) (큐란 정(염산라니티딘 150 mg)에 대한 수도염산라니티딘정의 생물학적동등성)

  • Lee, Sun-Neo;Ko, Youn-Jung;Kang, Seung-Woo;Yoon, Seo-Hyun;Park, Moo-Sin;Lee, Ye-Ri;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.36 no.3
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    • pp.193-199
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    • 2006
  • A bioequivalence study of $Sudo^{TM}$ Ranitidine HCI tablet (Sudo Pharma. Ind. Co., Ltd.) to $Curan^{TM}$ tablet (Il Dong 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 ranitidine hydrochloride dose of 150 mg in a 2x2 crossover study. There was a one week wash-out period between the doses. Plasma concentrations of ranitidine were monitored by a high-turbulent liquid chromatography (HTLC) for over a period of 12 hours after drug 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 far 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 $Sudo^{TM}$ Ranitidine $HCl/Curan^{TM}$ were 0.92-1.00 and 0.90-1.03, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Sudo^{TM}$ Ranitidine HCI and $Curan^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of MelaxTM Capsule to MobicTM Capsule (Meloxicam 7.5 mg) (모빅 캡슐(멜록시캄 7.5 mg)에 대한 멜락스 캡슐의 생물학적동등성)

  • Lee, Ye-Rie;Yeom, Seung-Bock;Ko, Youn-Jung;Ko, Jung-Kil;Kim, Ho-Hyun;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.5
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    • pp.413-418
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    • 2004
  • A bioequivalence of $Melax^{TM}$ capsules (Chong Kun Dang Pharm., Korea) and $Mobic^{TM}$ capsules (Boehringer Ingelheim Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 15 mg dose of meloxicam of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2\;{\times}\;2$ crossover design. Concentrations of meloxicam 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 72 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 $Melax^{TM}/Mobic^{TM}$ were 0.95 - 1.04 and 0.98 - 1.14, respectively. This study demonstrated a bioequivalence of $Melax^{TM}$ and $Mobic^{TM}$ with respect to the rate and extent of absorption.

Breakdown Characteristics of Teflon by N2-O2 Mixture gas (N2-O2 혼합가스에 따른 Teflon의 절연파괴특성)

  • Choi, Eun-Hyeok;Choi, Byoung-Sook;Park, Sung-Gyu
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.1
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    • pp.69-74
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    • 2018
  • With the increasing development of industrial society and the availability of high quality electrical energy, the simplification of operation and maintenance procedures is required, in order to ensure the reliability and safety of electrical systems. In this paper, the dielectric breakdown characteristics of $N_2-O_2$ mixed gas solid insulation, which is used as an alternative to SF6 in various electric power facilities, are verified. When the gas mixture has a composition ratio similar to that of the atmosphere, the dielectric breakdown characteristics are relatively stabilized. It was confirmed that the breakdown voltage of the gas in the electrode near an equal electric field increased with increasing pressure according to Paschen's rule. The breakdown voltage of the surface increased linearly with increasing pressure, and the difference was caused by the mixing ratio of $O_2$ gas. This change in the surface insulation breakdown voltage was caused by the influence of the electrically negative $O_2$ gas and the intermolecular collision distance. In this study, the influence of the intermolecular impact distance was larger (than that in the absence of the electrically negative $O_2$ gas). The breakdown voltage relation applicable to Teflon according to the surface insulation characteristics was calculated. The characteristics of the surface insulation properties of Teflon, which is used as a solid insulation material, were derived as a function of pressure. It is thought that these results can be used as the basic data for the insulation design of electric power facilities.

Bioequivalence of Boryung Torsemide Tablet to Torem Tablet (Torasemide 10 mg) by High Performance Liquid Chromatography/UV Detector

  • Cho, Hea-Young;Kang, Hyun-Ah;Park, Chan-Ho;Kim, Se-Mi;Kim, Dong-Ho;Park, Sun-Ae;Kim, Kyung-Ran;Hur, Hyeon;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.5
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    • pp.323-328
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    • 2005
  • The purpose of the present study was to evaluate the bioequivalence of two torasemide tablets, Torem tablet (Roche Korea Co., Ltd., Korea, reference drug) and Boryung Torsemide tablet (Boryung Pharmaceutical Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (furosemide) to human serum, serum samples were extracted using 5 mL of ethyl acetate. Compounds were analyzed by reverse-phase HPLC method with UV detection. This method showed linear response over the concentration range of 0.05 ug/mL with correlation coefficient of 0.999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ug/mL which was sensitive enough for pharmacokinetic studies. Twenty-eight healthy male Korean volunteers received each medicine at the torasemide dose of 20 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Serum concentrations of torasemide were monitored by an HPLC-UV for over a period of 12 hr after the administration. $AUC_{t}$(the area under the serum concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum serum drug concentration) and $T_{max}$ (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 Boryung Torsemide/Torem were log 0.97-10g 1.03 and log 0.93log 1.12, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Boryung Torsemide tablet and Torem tablet are bioequivalent.

Bioequivalence of LosartanTM Tablet to CozzarTM Tablet (Losartan Kalium 50 mg) (코자 정(로자탄 칼륨 50 mg)에 대한 로자르탄 정의 생물학적동등성)

  • Kim, Yong-Won;Park, Wan-Su;Kim, Sung-Su;Seo, Ji-Hyung;Cho, Sung-Hee;Lee, Heon-Woo;Rew, Jae-Hwan;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.36 no.2
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    • pp.131-136
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    • 2006
  • The purpose of the present study was to evaluate the bioequivalence of two losartan tablets, $Cozaar^{TM}$ tablet (MSD Korea. Co., Ltd., Seoul, Korea, reference drug) and $Losartan^{TM}$ tablet (DaeWon Pharm. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets at the losartan kalium dose of 100 mg in a $2\;{\time}\;2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of losartan were monitored by an LC-MS/MS for over a period of 12 hr 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 $C_{max}$ ratio for $Cozaar^{TM}/Losartan^{TM}$ were $log\;0.97{\sim}log\;1.12\;and\;log\;0.93{\sim}log\;1.23$, respectively. These values were within the acceptable bioequivalence intervals of $log\;0.80{\sim}log\;1.25$. Taken together, our study demonstrated the bioequivalence of $Cozaar^{TM}$ and $Losartan^TM$ with respect to the rate and extent of absorption.

Bioequivalence of NimegenTM Soft Capsule to RoAccutane® Soft Capsule (Isotretinoin 10 mg) (로아큐탄 연질캡슐(이소트레티노인 10 mg)에 대한 니메겐 연질캡슐의 생물학적동등성)

  • Yang, Seung-Kwon;La, Sook-Ie;Chang, Kyu-Young;Lee, Yun-Young;Yoon, Mi-Kyeong;Lew, Soo-Hyun;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.37 no.4
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    • pp.255-261
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    • 2007
  • A bioequivalence study of $Nimegen^{TM}$ soft capsule (Medica Korea Pharma. Co., Ltd.) to $RoAccutane^{(R)}$ soft capsule (Roche Korea Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty healthy male Korean volunteers received each medicine at the isotretinoin dose of 60 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of isotretinoin were monitored by a high performance liquid chromatography (HPLC) for over a period of 48 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48 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 $Nimegen^{TM}/RoAccutane^{(R)}$ were $log0.860{\sim}log0.98\;and\;log0.85{\sim}log1.00$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Thus, our study demonstrated the bioequivalence of $Nimegen^{TM}\;and\;RoAccutane^{(R)}$ with respect to the rate and extent of absorption.