• Title/Summary/Keyword: $C_{max}$

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COB, COH Package LED Module Thermal Analysis Simulation (COB, COH Package LED Module 열 해석 시뮬레이션)

  • Choi, Keum-Yeon;Eo, Ik-Soo
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.12 no.11
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    • pp.5117-5122
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    • 2011
  • In this paper, thermal analysis simulation program by taking advantage of COMSOL Multiphysics, LED Module for the production of the most preferred package type, omitting the COH Type COB Type and board simulation of the thermal analysis is in progress. LED Module that passes through the Heat-sink of the simulation results, depending on the location of the COB Type Max. Approximately $78^{\circ}C$ ~ Min. Approximately $62^{\circ}C$, COH Type the Max. Approximately $88^{\circ}C$ ~ Min. Approximately $67^{\circ}C$ has been confirmed that the temperature stability. Compared with COB Type Max. AIthough temperature difference is about $10^{\circ}C$, Min. At a temperature of about $5^{\circ}C$ confirmed to be enough to reduce the gap, LED Point confirming the results of the temperature curves for COB Type Max. Approximately $100^{\circ}C$ ~ Min. Approximately $77^{\circ}C$, COH Type the Max. Approximately $100^{\circ}C$ ~ Min. Approximately $86^{\circ}C$ temperature stability was confirmed that, COB Type COH Type, compared to approximately $10^{\circ}C$ temperature was higher.

Bioequivalence of Terbinex Tablet to Lamisil Tablet (Terbinafine 125mg) (라미실 정(테르비나핀 125mg)에 대한 터비넥스 정의 생물학적동등성)

  • 고현철;홍정희;신인철
    • Biomolecules & Therapeutics
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    • v.11 no.1
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    • pp.65-71
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    • 2003
  • Terbinafine is a synthetic allylamine that is available in an oral formulation and is used at a dosage of 250mg/day. It is used as an active antifungal agent and inhibits the fungal enzyme squalene epoxidase, which leads to the accumulation of the sterol squalene, which is toxic to the organism. The purpose of the present study was to evaluate the bioequivalence of two terbinafine tablets, Lamisil (Novartis Korea Ltd.) and Terbinex (C-TRI Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 26.00$\pm$2.57 year in age and 70.51$\pm$9.36 kg in body weight, were divided into two groups and a randomized 2${\times}$2 cross-over study was employed. After one tablet containing 125 mg of terbinafine was orally administered, blood was taken at predetermined time intervals and the concentrations of terbinafine in plasma were determined using HPLC with UV detector. Pharmacokinetic parameters such as AUC, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC, $C_{max}$ and $T_{max}$ between two tablets were -4.191%, 5.223% and -25.720%, respectively when calculated against the Lamisil, tablet. The powers (1-$\beta$) for AUC, $C_{max}$ and $T_{max}$ were 81%, 87% and below 60%, respectively. Minimum detectable differences(.il) at alpha=O.1 and 1-/3=0.8 were less than 20% (e.g., 19.72% and 17.77% for AUC and $C_{max}$, respectively). But minimum detectable differences($\Delta$) at alpha=0.1 and 1-$\beta$=0.8 for $T_{max}$ were more than 20% (e.g., 26.25%). The 90% confidence intervals were within $\pm$20% (e.g., -17.440∼9.06 and -6.713∼17.160 for AUC and $C_{max}$ respectively). But 90% confidence intervals for $T_{max}$ were not within $\pm$20% (e.g., -43.346∼8.083). Another ANOVA test was conducted for logarithmically transformed AUC and $C_{max}$. These results showed that there are no significant differences in AUC and $C_{max}$ between the two formulations: The differences between the formulations in these log transformed parameters were all for less than 20% (e.g., -4.19% and 5.22% for AUC and $C_{max}$, respectively). The 90% confidence intervals for the log transformed data were not the acceptance range of log 0.8 to log 1.25 in AUC but the acceptance range of log 0.8 to log 1.25 in $C_{max}$ (e.g., log 1.13∼log 1.50 and log 0.94-log 1.22 for AUC and $C_{max}$ respectively). The major parameters, AUC and $C_{max}$ met the criteria of KFDA for bioequivalence although $T_{max}$ did not meet the criteria of KFDA (1998 year) for bioequivalence, indicating that Onfran tablet is bioequivalent to Zofran tablet. But in another ANOVA test AUC did not meet the criteria of KFDA (2002) for bioequivalence but $C_{max}$ met the criteria of KFDA (2002 year) for bioequivalence.or bioequivalence.equivalence.equivalence.equivalence.

Bioequivalence of Onfran Tablet to Zofran Tablet (Ondansetron 8mg) (조프란 정(온단세트론 8mg)에 대한 온프란 정의 생물학적동등성)

  • 신인철;홍정욱;박윤영;고현철
    • Biomolecules & Therapeutics
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    • v.11 no.1
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    • pp.58-64
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    • 2003
  • Ondansetron is a potent, highly selective 5-hydroxytryptamin $e_3$(5-H $T_3$) receptor-antagonist, for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiography, and the treatment of post-operative nausea and vomiting. The purpose of the present study was to evaluate the bioequivalence of two ondansetron tablets, Zofran (Glaxo Smithcline Korea Ltd.) and Onfran (Korea United Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 24.39$\pm$1.69 year in age and 69.00$\pm$6.74kg in body weight, were divided into two groups and a randomized 2${\times}$2 cross-over study was employed. After one tablet containing 8mg of ondansetron was orally administered, blood was taken at predetermined time intervals and the concentrations of ondansetron in plasma were determined using HPLC with UV detector. Pharmacokinetic parameters such as AVC, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC, $C_{max}$ and T max between two tablets were 5.83%, 5.75% and -5.71%, respectively when calculated against the Zofran, tablet. The powers (1-$\beta$) for AUC, $C_{max}$ and $T_{max}$ were above 90%, above 90% and below 60%, respectively. Minimum detectable differences($\Delta$) at alpha=0.1 and 1-$\beta$=0.8 were less than 20% (e.g., 12.74% and 11.78% for AUC and $C_{max}$ respectively). But minimum detectable differences($\Delta$) at alpha=0.1 and 1-$\beta$=0.8 for $T_{max}$ were more than 20% (e.g., 34.22%). The 90% confidence intervals were within $\pm$20% (e.g., -2.73∼14.39 and -2.16∼13.67 for AUC and $C_{max}$ respectively). But 90% confidence intervals for $T_{max}$ were not within $\pm$20% (e.g., -28.71∼17.28). Another ANOVA test was conducted for logarithmically transformed AUC and $C_{max}$. These results showed that there are no significant difference in AUC and $C_{max}$ between the two formulations: The differences between the formulations in these log transformed parameters were all for less than 20% (e.g., 5.83% and 5.75% for AUC and $C_{max}$ respectively). The 90% confidence intervals for the log transformed data were the acceptance range of log 0.8 to log 1.25 (e.g., log 0.99∼log 1.15 and log 0.98∼log 1.15 for AUC and $C_{max}$ respectively). The major parameters, AUC and $C_{max}$, met the criteria of KFDA for bioequivalence although $T_{max}$ did not meet the criteria of KFDA for bioequivalence, indicating that Onfran tablet is bioequivalent to Zofrm1 tablet.t is bioequivalent to Zofrm1 tablet.m1 tablet.m1 tablet.m1 tablet.

Bioequivalence Study of Acetyl-L-Carnitine Tablets (아세틸-엘-카르니틴 정제의 생물학적 동등성 평가)

  • 박경미;이미경;신지영;임수정;임윤영;김종국;우종수
    • Biomolecules & Therapeutics
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    • v.9 no.4
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    • pp.285-290
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    • 2001
  • Bioequivalence of two acetyl-1-carnitine tablets, test product (Carnitile tablet: Hanmi Pharm. Co., Ltd.) and reference product (Nicetil $e^{R}$ tablet: Dong-A Pharm. Co., Ltd.), was evaluated according to the guide- lines of Korea Food and Drug Administration (KFDA). Twenty-six healthy volunteers were divided randomly into two groups and administered the drug orally at the dose of 500 mg as acetyl-1-carnitine in a 2$\times$2 crossover study. Blood samples were taken at predetermined time intervals for 12 hours and the plasma concentration of acetyl-1-carnitine was determined using HPLC by derivatization with p-bromophenacyl bromide. The pearmacokinetic parameters (AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$) were calculated and ANOVA was utilized for the statistical analysis of parameters. The apparent differences of these parameters between two drugs were less than 20% (i.e., 1.26,-5.08 and 8.59% for AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$, respectively). The powers (1-$\beta$) for AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$, and Tmax were over 0.9. Minimal detectable difference ($\Delta$) at $\alpha$=0.05, 1-$\beta$=0.8 were less than 20% (i.e.,7.31, 14.88 and 11.77% for AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$, respectively). The confidence intervals ($\delta$) for these parameters were also within $\pm$ 20% (i.e.,-3.03$\leq$$\delta$$\leq$5.54, -13.80$\leq$$\delta$$\leq$3.64 and 1.69$\leq$$\delta$$\leq$15.48 for AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$, respectively). These results satisfied the criteria of KFDA guideline for bioequivalence, indicating Carnitile bioequivalent to Nicetil $e^{R}$ .TEX>$^{R}$ .> R/ . R/ .

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Effect of Lactic Acid Bacterium on Antioxidative and ACE inhibitory activity in Dolsan Leaf Mustard Kimchi (유산균 농도가 돌산갓김치의 항산화효과 및 ACE 저해활성에 미치는 효과)

  • 최명락;유은정;임현수
    • Journal of Life Science
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    • v.13 no.1
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    • pp.59-66
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    • 2003
  • The bacterial strain was isolated from the 4th day's fermented Dolsan Leaf Mustard Kimchi(DLMK) at $20^{\circ}C$/TEX>. It was used as Kimchi starter, and then its physiological activity was investigated for 50 days at $4^{\circ}C$/TEX> and $10^{\circ}C$/TEX> The physiological activity of DLMK was examined for both antioxidative and Angiotensine Converting Enzyme(ACE) inhibitory activity. In the starter-inoculated DLMK(1 X $10^{10}$ CFU/mL) at 4 and $10^{\circ}C$, the optimal ripening period was more shortend than that of control(without starter) up to about 5.6 and 5 times, respectively. The maximal antioxidative activity in the starter-inoculated DLMK(1 X $10^{10}$ 10 CFU/mL) at 4 and $10^{\circ}C$ were 67% and 75%, respectively. The yield of cell concentration per day($lnX_{max}$/$t_{max}$) and the yield of antioxidative activity per day($P_{max}$/t$t_{max}$) had a linear relationship. Also, the yield of antioxidative activity per day was increased with increasing the concentration of inoculated bacterium. By adding 1 X $10^{10}$ CFU/mL at 4 and $10^{\circ}C$, the ACE inhibitory activity of DLMK was maximal. The rates of inhibiting activities were 52% and 76%, respectively. Consequently, physiological activities were significantly affected by the inoculation concentrations of starter, but bacterium itself was not appeared the physiological activity. We assume that the bacterium metabolizes certain materials in DLMK and released compounds such as glucosinolates or its metabolized forms from DLMK show the antioxidative and ACE inhibitory activity.

Process Parameter Control of Arc Melting Process for Ti3SiC2 MAX Phase Synthesis (Ti3SiC2 MAX Phase 합성을 위한 Arc Melting 공정 제어)

  • Nou, Chang Wan;Kim, Byeong Guen;Bae, Sang Hyun;Choi, Soon-Mok
    • Journal of the Korean Institute of Electrical and Electronic Material Engineers
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    • v.33 no.6
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    • pp.515-520
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    • 2020
  • The Ti3SiC2 MAX phase was synthesized by arc-melting process under three different processing times. We confirmed that the reaction between the TiCX phase and Ti-Si liquid phase is important for the synthesis of the Ti3SiC2 MAX phase. Results suggest that the Ti3SiC2 MAX phase decomposed when the arc-melting time was greater than 80s. Herein, we aim to determine the detailed parameters for the reported arc-melting process, which can provide useful insights on the synthesis of the Ti3SiC2 MAX phase by arc-melting process. Furthermore, we compared the electrical characteristics and densities of the three samples.

Contrast Sensitivity as a function of spatial frequency by using polarization (편광을 이용한 눈의 공간주파수-대비민감도 함수 측정기구 설계)

  • Kim, Young-Geun
    • Journal of Korean Ophthalmic Optics Society
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    • v.5 no.1
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    • pp.43-48
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    • 2000
  • It was to adjust the luminance of light by the rotation angle of the polarizes and analyzer. The luminance value Lmax, Lmin of Contrast Sensitivity could be obtained from the rotation angle ${\theta}_m$ of the average luminance($L_m$), the rotation angle(${\theta}_{max}$, ${\theta}_{min}$) of the maximum and the minimum's amplitude. $$L_{max}=I(0)e^{-2at}{\cdot}cos^2{\theta}_m(1+C_s^{-1})$$ $$L_{min}=I(0)e^{-2at}{\cdot}cos^2{\theta}_m(1-C_s^{-1})$$ We obtained the rotation angle(${\theta}_{max}$, ${\theta}_{min}$) of the polarizes and analyzer from the rotation angle ${\theta}_m$ of the average luminance($L_m$) and the Contrast Sensitivity($C_s$). $${\theta}_{max}=cos^{-1}[cos{\theta}_m{\cdot}(1+C_s^{-1})^{1/2}]$$ $${\theta}_{min}=cos^{-1}[cos{\theta}_m{\cdot}(1-C_s^{-1})^{1/2}]$$.

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Bioequivalence Test of Rifampicin Preparations(II) (리팜피신 제제의 생물학적 동등성시험(제2보))

  • Chang, Il-Hyo;Burm, Jin-Pil;Choi, Jun-Shik
    • Journal of Pharmaceutical Investigation
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    • v.24 no.2
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    • pp.49-55
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    • 1994
  • Bioequivalence test of commercially available rifampicin capsules was performed. Sixteen volunteers were divided into 2 groups and the reference and test drug were given orally (450 mg) by cross-over design. Statistical evaluation of AUC, $C_{max}\;and\;T_{max}$ involved an analysis of variance (ANOVA). The differences of mean value in AUC, $C_{max}\;and\;T_{max}$ between the reference and test drug were within 20% with reference drug. ANOVA showed no significant differences for ‘between group’, ‘drug’ and ‘period’, but not for ‘between subjects’. The power of test $(1-{\beta})\;of\;AUC\;and\;$C_{max}$ was larger than 0.8 and the confidence of bioavailability was $within\;{\pm}20%$. From these results, it was concluded that the two preparations were bioequivalent for AUC and $C_{max}$, but was not for $T_{max}$.

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Relationship between Cone Tip Resistance and Small-Strain Shear Modulus of Cemented Sand (고결모래의 콘선단저항과 미소변형전단탄성계수 관계)

  • Lee, Moon-Joo;Lee, Woo-Jin;Kim, Jae-Jeong;Choi, Young-Min
    • Proceedings of the Korean Geotechical Society Conference
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    • 2009.03a
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    • pp.331-340
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    • 2009
  • This study evaluates the relationship between cone tip resistance ($q_c$) and small-strain shear modulus ($G_{max}$) of cemented sand. For this purpose, a series of miniature cone penetration and bender element tests are performed in calibration chamber specimens with various gypsum contents. Experimental results show that both $q_c$ and $G_{max}$ of sand increase with increasing cementation level as well as relative density and vertical confining stress. However, the relative density and vertical confining stress has more significant influence on $G_{max}$ and $q_c$ of uncemented sand than those of cemented sand. It is observed that the $G_{max}/q_c$ ratio of cemented sand decreases with increasing relative density. This result means that state variables have more affect on $q_c$ than $G_{max}$ of cemented sand. Test results also show that the effect of vertical stress on $G_{max}-q_c$ relation is reduced by cementation effect.

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Bioequivalence Evaluation of the Cisapride Formulation Produced by Dong Wha Pharmaceutical Co. (동화약품 시사프리드제제의 생물학적 동등성 평가)

  • 윤광희;박진영;박선주;조은희;유제만;김경식;정석재;이민화;심창구
    • Biomolecules & Therapeutics
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    • v.7 no.1
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    • pp.59-65
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    • 1999
  • A bioequivalence study of the Dong Wha Cisapril tablets(Dong Wha Pharm. Ind. Co., Ltd.) to the Prepulsid tablets(Janssen Korea Ltd.), formulations of cisapride, was conducted. Twenty four healthy Korean male subjects received each formulation at the dose of 5 mg as cisapride in a 2$\times$2 crossover study. There was a 1-week washout period between the doses. Plasma concentrations of cisapride were monitored by an LC/MS method for over a period of 36 h after each administration. AUC(area under the plasma concentration- time curve from time zero to infinity) was calculated by the linear trapezoidal and extrapolation method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, $C_{max}$ and $T_{max}$ between the formulations. The apparent differences between the formulations in these parameters were all far less than 20% (i.e., 6.8, -6.6 and 1.8% for AUC, $C_{max}$ and $T_{max}$, respectively). Minimum detectable differences(%) at $\alpha$=0.05 and 1-$\beta$=0.8 were all less than 20% in these parameters between the formulations (i.e., 16.5, 11.4 and 16.4% for AUC, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within 20% (i.e., -2.9~ 16.4, -13.2~0.1 and -7.8~ 11.4% for AUC, $C_{max}$ and $T_{max}$, respectively). These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 98-51). Therefore, these results indicate that the two formulations of cisapride are bioequivalent and, thus, may be prescribed interchangeably.hangeably.y.hangeably.

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