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Bioequivalence of Famcivir Tablet to FamvirTM Tablet 250 mg (Famciclovir 250 mg) (팜비어 정 250밀리그람(팜시클로버 250 mg)에 대한 팜시버 정의 생물학적동등성)

  • Kang, Hyun-Ah;Cho, Hea-Young;Oh, In-Joon;Lee, Myung-Hee;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.4
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    • pp.295-301
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    • 2005
  • Famciclovir is an oral prodrug of the antiherpesvirus nucleoside analogue, penciclovir. In human, famciclovir is orally well absorbed and then undergoes extensive first pass metabolism to penciclovir and essentially no parent compound is recovered from plasma or urine. The purpose of the present study was to evaluate the bioequivalence of two famciclovir tablets, $Famvir^{TM}$ tablet 250 mg (Novartis Korea Ltd.) and Famcivir (Hanmi Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of famciclovir from the two famciclovir formulations in vitro was tested using KP VIII Apparatus II method with water. Twenty six healthy male subjects, $24.19{\pm}2.08$ years in age and $71.55{\pm}6.89$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 250 mg as famciclovir was orally administered, blood samples were taken at predetermined time intervals and the concentrations of penciclovir in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar at water. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Famvir^{TM}$ tablet 250 mg, were -2.93, -8.02 and 10.47% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., $log0.92{\sim}log1.01$ and $log0.85{\sim}log1.00$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Famcivir was bioequivalent to $Famvir^{TM}$ tablet 250 mg.

Bioequivalence of Flucona Capsule to Diflucan Capsule (Fluconazole 50 mg) (디푸루칸 캅셀(플루코나졸 50 mg)에 대한 플루코나 캅셀의 생물학적 동등성)

  • Cho, Hea-Young;Kang, Hyun-Ah;Lee, Suk;Oh, In-Joon;Lim, Dong-Koo;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.33 no.2
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    • pp.135-140
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    • 2003
  • Fluconazole is an orally active bis-triazole antifungal agent, which is used in the treatment of superficial and systemic candidiasis and in the treatment of cryptococcal infections in patients with the acquired immuno deficiency syndrome (AIDS). The purpose of the present study was to evaluate the bioequivalence of two fluconazole capsules, Diflucan (Pfizer Pharmaceuticals Korea Inc.) and Flucona (Korean Drug Pharmaceuticals Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The fluconazole release from the two fluconazole capsules in vitro was tested using KP VII Apparatus II method at 0.1 M hydrochloride dissolution media. Twenty normal male volunteers, $23.60{\pm}1.88$ years in age and $63.57{\pm}6.17\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three capsules containing 50 mg as fluconazole was orally administered, blood was taken at predetermined time intervals and the concentrations of fluconazole in serum were determined using HPLC method with UV detector. The dissolution profiles of two fluconazole capsules were very similar at 0.1 M hydrochloride dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$ and untransformed $T_{max}$. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two capsules based on the Diflucan were 4.96%, 5.65% and -13.76%, respectively. There were no sequence effects between two capsules in these parameter. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) $(e.g.,\;log(1.01){\sim}log(1.08)\;and\;log(1.00){\sim}log(1.12)\;for\;AUC_t\;and\;C_{max},\;respectively)$, indicating that Flucona capsule is bioequivalent to Diflucan capsule.

Bioequivalence of S-napine Tablet 10 mg to Alesion Tablet(Epinastine HCl 10 mg) (알레지온 정(염산에피나스틴 10mg)에 대한 에스나핀 정 10밀리그람의 생물학적동등성)

  • Kang, Hyun-Ah;Cho, Hea-Young;Yoon, Hwa;Kim, Se-Mi;Kim, Dong-Ho;Park, Sun-Ae;Kim, Hwan-Ho;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.36 no.6
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    • pp.405-411
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    • 2006
  • Epinastine is an antiallergic drug effective for bronchial asthma, allergic rhinitis, urticaria and dermatitis. Epinastine is topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from the mast cell. The purpose of the present study was to evaluate the bioequivalence of two epinastine hydrochloride tablets, Alesion Tablet (Boehringer Ingelheim Korea Ltd.) and S-napine tablet 10 mg(Sam Chun Dang Pharm. Co., Ltd), according to the guidelines of the Korea Food and Drug Administration(KFDA). The release of epinastine from the two epinastine formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media(pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $23.35{\pm}1.57$ years in age and $66.29{\pm}10.61kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 20 mg as epinastine hydrochloride was orally administered, blood was taken at predetermined time intervals and the concentrations of epinastine in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t.\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Alesion tablet, were 1.50, 1.46 and -13.48% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25(e.g., log 0.95$\sim$log 1.12 and log 0.93$\sim$log 1.10 for $AUC_t\;and\;C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating S-napine tablet 10 mg was bioequivalent to Alesion tablet.

Bioequivalence of Famvir Tablet 750 mg to Famcivir Tablet 750 mg (Famciclovir 750 mg) (팜비어 정 750밀리그람(팜시클로버 750밀리그람)에 대한 팜시버 정 750밀리그람의 생물학적동등성)

  • Kim, Se-Mi;Yoon, Hwa;Yoo, Hee-Doo;Kim, Kyung-Ran;Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.38 no.3
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    • pp.199-205
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    • 2008
  • Famciclovir, 9-(4-hydroxy-3-hydroxymethylbut-1-yl) guanine, is an oral prodrug of the antiherpesvirus nucleoside analogue, penciclovir. In human, famciclovir is orally well absorbed and then undergoes extensive first pass metabolism to penciclovir and essentially no parent compound is recovered from plasma or urine. The purpose of the present study was to evaluate the bioequivalence of two famciclovir tablets, Famvir tablet 750 mg (Novartis Korea Ltd.) and Famcivir tablet 750 mg (Hanmi Pharmaceutical. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of famciclovir from the two famciclovir formulations in vitro was tested using KP VIII Apparatus II method with water. Twenty six healthy male subjects, $23.38{\pm}1.72$ years in age and $68.59{\pm}7.84\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 750 mg as famciclovir was orally administered, blood samples were taken at predetermined time intervals and the concentrations of penciclovir in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations ere similar at water. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Famvir^{(R)}$ tablet 750 mg, were -0.53%, 1.12% and -24.82% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log\;0.9569{\sim}log\;1.0423$ and $log\;0.8763{\sim}log\;1.2136$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Famcivir tablet 750 mg was bioequivalent to Famvir tablet 750 mg.

Regional Development and Regional Geography (지역개발론(地域開發論)과 지역지리학(地域地理學))

  • Kim, Duk-Hyun
    • Journal of the Korean association of regional geographers
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    • v.8 no.2
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    • pp.170-183
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    • 2002
  • Recently it is supposed to be a shift to regional geography. To understand the emergence of the new regional geography, It must be remarked that the progress of capitalist production and consumption change our conceptional apparatus such as representation of space. Region is one of the important mode of representations of space and time. In the Fordist capitalism of 20th century, development is regarded as diffusion of capitalist expansion of western worlds. State must support capitalist growth through regional policies which include constructing of infrastructure and regionalization of spatial division of labour. The regional development theories contributed as ideology and policy tools for state intervention. The region was simply one of the most logical classification tools of organizing geographical informations. In the theories of regional development, the concept of region was reduced to the formal unit of classification. As the transition from Fordism to flexible accumulation, the region is again acquiring its 'identity' and 'authenticity'. In this tendency of the revival of region, it is expected that good achievement could be made in the field of regional geography through relevant research methods. It is also believed one of the available means are historical approaches to the cultural and ecological regions. The historical approaches to cultural and ecological regions are not only correspondent with cultural development strategies of local governments, but also could convey regional identities through both narrativization of place and aestheticization of landscape.

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Separation of chlorine in a uranium compound by pyrohydrolysis and steam distillation, and its determination by ion chromatography (열가수분해 및 수증기증류에 의한 우라늄 화합물 중 염소 분리 및 이온크로마토그래피 정량)

  • Kim, Jung-Suk;Lee, Chang-Hun;Park, Soon-Dal;Han, Sun-Ho;Song, Kyu-Seok
    • Analytical Science and Technology
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    • v.23 no.1
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    • pp.45-53
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    • 2010
  • For the determination of chlorine in uranium compound, analytical methods by using a steam distillation and a pyrohydrolysis have been developed. The steam distillation apparatus was composed of steam generator, distilling flask and condenser etc. The samples were prepared with an aliquot of LiCl standard solution and a simulated spent nuclear fuel. A sample aliquot was mixed with a solution containing 0.2 M ferrous ammonium sulfate-0.5 M sulfamic acid 3 mL, phosphoric acid 6 mL and sulfuric acid 15 mL. The chloride was then distilled by steam at the temperature of $140^{\circ}C$ until a volume of $90{\pm}5\;mL$ is collected. The pyrohydrolysis equipment was composed of air introduction system, water supply, quartz reaction tube, combustion tube furnace, combustion boat and absorption vessel. The chloride was separated from powdered sample which is added with $U_3O_8$ accelerator, by pyrohydrolysis at the temperature of $950^{\circ}C$ for 1 hour in a quartz tube with a stream of air of 1 mL/min supplied from the water reservoir at $80^{\circ}C$. The chlorides collected in each absorption solution by two methods was diluted to 100 mL and measured with ion chromatography to determine the recovery yield. For the ion chromatographic determination of chlorine in molten salt retained in a metal ingot, the chlorine was separated by means of pyrohydrolysis after air and dry oxidation, and grinding for the sample.

High-Pressure Solubility of Carbon Dioxide in 1-Butyl-3-methylpiperidinium Bis(trifluoromethylsulfonyl)imide Ionic Liquid (1-Butyl-3-methylpiperidinium Bis(trifluoromethylsulfonyl)imide 이온성 액체에 대한 이산화탄소의 고압 용해도)

  • Nam, Sang-Kyu;Lee, Byung-Chul
    • Analytical Science and Technology
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    • v.27 no.2
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    • pp.79-91
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    • 2014
  • Solubility data of carbon dioxide ($CO_2$) in 1-butyl-3-methylpiperidinium bis(trifluoromethylsulfonyl)imide ($[bmpip][Tf_2N]$) ionic liquid are presented at pressures up to about 30 MPa and at temperatures between 303 K and 343 K. As far as we know, the data on the $CO_2$ solubility in the $[bmpip][Tf_2N]$ ionic liquid have never been reported in the literature by other investigators. The solubilities of $CO_2$ were determined by measuring the bubble point or cloud point pressures of the $CO_2+[bmpip][Tf_2N]$ mixtures with various compositions using a high-pressure equilibrium apparatus equipped with a variable-volume view cell. To observe the effect of the cation composing the ionic liquid on the $CO_2$ solubility, the $CO_2$ solubilities in $[bmpip][Tf_2N]$ used in this study were compared with those in 1-butyl-3-methylimidazolium bis(trifluoromethylsulfonyl)-imide ($[bmim]Tf_2N]$). As the equilibrium pressure increased, the $CO_2$ solubility in $[bmpip][Tf_2N]$ increased sharply. On the other hand, the $CO_2$ solubility decreased with increasing temperature. The mole fraction-based $CO_2$ solubilities were almost the same for both $[bmpip][Tf_2N]$ and $[bmim][Tf_2N]$, regardless of temperature and pressure. The phase equilibrium data for the $CO_2+[bmpip][Tf_2N]$ systems have been correlated using the Peng-Robinson equation of state.

Research on the Decolorization of Epoxy Polymer by Accelerated Solar Radiation Test (태양광 복사 가속화 시험을 통한 에폭시 폴리머의 색 변화 특성 연구)

  • Lee, Sang-Bong;Lee, Dong-Geon;Kim, Myung-Jun;Lee, Soo-Yong;Park, Jung-Sun;Kang, Tae-Yeop;Baek, Sang-Hwa
    • Journal of the Korean Society for Aeronautical & Space Sciences
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    • v.44 no.11
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    • pp.949-956
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    • 2016
  • There are a number of effects by solar radiation in many aerospace industrial fields, such as degradation of mechanical properties, sealing effect of sealants or decolorization. Because it takes long time to investigate these effects by using the light of natural state, new methods are developed for accelerating this phenomenon. In this paper, we developed an apparatus to simulate accelerated solar radiation phenomenon selecting irradiation intensity $1,120W/m^2$ as the designed environment. Epoxy polymer as the composite material was chosen and processed by ASTM-D638, a reference for tensile test of polymer and plastic. Total color shift was selected as the test category to evaluate acceleration of the test. We obtained acceleration factors and numerical model from test data and concluded it can shorten test periods by accelerated irradiation intensity of $1,120W/m^2$.

Automation of Longline -Automation of the Alaska Pollack Longline- (주낙어구의 자동화 -명태주낙어업의 자동화-)

  • KO Kwan-Soh;YOON Gab-Dong;LEE Chun-Woo
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.20 no.2
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    • pp.106-113
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    • 1987
  • The Alaska pollack longline operations, which consist of baiting, shooting, hauling and arrangement of hooks, are dependant on manual labour up to the present. The automation against this traditional way is necessary to eliminate the manual operations and to reduce crew. We have developed a prototype longline system suitable for Alaska pollack longline gear, which is composed of an automatic baiting machine, an automatic line hauler, a hook cleaner and storage rails. The automatic bailing machine driven by hydraulic power is precise baiting method controlled sequentially, and the automatic line hauler is to haul up the mainline by means of hydraulic power and at the same time to split every hook and to carry it onto storage rail automatically. A series functioning tests on shooting and hauling apparatus were carried out in the laboratory and at sea. The results obtained are as follows ; 1. As for the baiting machine, the exciting time of solenoid which operates a directional valve, bait feeding and cutting time, is shortened according to the increase of pressure, and also, after cutting the bait, the over-rotated angle of the blade increased in accordance with the increase of pressure. 2. The baiting efficiency is about $90\%$ when using sand lance (Hypoptychus dybowskii), and the most proper pressure of the hydraulic circuit in feeding and cutting the bait is between $13\;kgf/cm^2\;and\;20\;kgf/cm^2$. 3. The hook splitting rate of the automatic line hauler is about $95.5\%$ regardless of hauling speed and materials of snood. 4. The case of unseparating hook is appeared when the snood gets entangled or the hook is sticked in the mainline.

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A Study on the Planning of In-Between Space Considering the Site Planning Characteristics of Elementary Schools -Focused on Newly-Built Elementary Schools in Sejong City- (초등학교 배치특성을 고려한 사이공간 계획방향에 관한 연구 -세종시 신설초등학교를 중심으로-)

  • Song, Byung-Ha
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.2
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    • pp.105-116
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    • 2018
  • This study started by examining 24 newly-built elementary schools in Sejong City with regard to their present conditions of in-between space. After categorizing the space according to its spatial composition, 5 schools were selected and analyzed in relation to the current status and frequency of use of their in-between space. Among the (other schools, the analysis gave the following results: 1) There was much higher usage of the in-between space for rest/play than for learning, which suggested that more rest/play area and apparatus should be provided. 2) Piloti areas were preferred, and a greater number of activities took place in these places than in the adjoining open areas. 3) When the in-between space was combined with a passage (as in the case of E2 and E3), a separation must be provided in order not to interfere with the rest/play activities. 4) In planning the in-between space, priority should be given to activities over landscape purposes. 5) Diverse and easy access to the space must be planned, particularly as the main entrance is not directly connected to the space. Entry at the end of an adjacent building could be a possible solution.