• Title/Summary/Keyword: $C_{max}$

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Bioequivalence of Cardil Tablet to Cardura Tablet (Doxazosin 2 mg) (카두라 정(독사조신 2 mg)에 대한 카르딜 정의 생물학적 동등성)

  • Cho, Hea-Young;Kim, Soo-Jin;Shim, Young-Sun;Lim, Dong-Koo;Oh, In-Joon;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.30 no.1
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    • pp.61-65
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    • 2000
  • Doxazosin, a postsynaptic selective ${\alpha}1-adrenoceptor$ antagonist, is a potent antihypertensive agent which reduces peripheral resistance and blood pressure by vasodilatation of peripheral vessels. It is also used in the treatment of urinary obstruction by benign prostatic hypertrophy. The purpose of the present study was to evaluate the bioequivalence of two doxazosin tablets, $Cardura^{TM}$ (Pfizer Korea Ltd.) and $Cardil^{TM};$ (Kyungdong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers, $24.19{\pm}2.48$ years in age and $62.41{\pm}6.66$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 2 mg of doxazosin was orally administered, blood was taken at predetermined time intervals and the concentrations of doxazosin in serum were determined with an HPLC method using spectrofluorometric detector. 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. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets were -1.54%, -1.51 % and 3.42%, respectively, when calculated against the $Cardura^{TM}$ tablet. The powers $(1-{\beta})$ for $AUC_t,\;C_{max}\;and\;T_{max}$ were all more than 99.00%. Minimum detectable differences $(\Delta)$ at ${\alpha}=0.05\;and\;1-{\beta}=0.8$ were all less than 20% (e.g., 12.73%, 12.84% and 13.01% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively). The 90% confidence intervals were all within :${\pm}20%$ (e.g., $-8.97{\sim}5.90,\;-9.01{\sim}6.00\;and\;-4.16{\sim}11.05\;for\;AUC_t,\;C_{max}\;and\;T_{max},\;respectively)$. All of the above para- meters met the criteria of KFDA for bioequivalence, indicating that $Cardil^{TM}$ tablet is bioequivalent to $Cardura^{TM}$ tablet.

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Bioequivalence of Hana Ondansetron Tablet to Zofran Tablet (Ondansetron 8 mg) (조프란 정(온단세트론 8 mg)에 대한 하나 온단세트론 정의 생물학적 동등성)

  • Cho, Hea-Young;Kim, Soo-Jin;Shim, Young-Sun;Lim, Dong-Koo;Oh, In-Joon;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.30 no.3
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    • pp.213-218
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    • 2000
  • Ondansetron is a potent, highly selective 5-hydroxytryptamine3(5-HT3) 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, $Zofran^{TM}$, (Glaxo Wellcome Korea Ltd.) and Hana ondansetron (Hana Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $23.56{\pm}1.79$ year in age and $67.35{\pm}8.35\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 8 mg of ondansetron was orally administered, blood was taken at predetermined time intervals and the concentrations of ondansetron in serum were determined using HPLC with UV detector. 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. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets were 7.53%, -0.23% and -3.92%, respectively when calculated against the $Zofran^{TM}$, tablet. The powers $(1-{\beta})$ for $AUC_t,\;C_{max}\;and\;T_{max}$ were above 99.00%, above 99.00% and 84.99%, respectively. Minimum detectable differences $(\Delta)\;at\;{\alpha}=0.1\;and\;1-{\beta}=0.8$ were all less than 20% (e.g., 12.25%, 10.88% and 18.37% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively). The 90% confidence intervals were all within ${\pm}20%$ (e.g., $-0.70{\sim}15.76,\;-7.53{\sim}7.08\;and\;-16.27{\sim}8.42\;for\;AUC_t,\;C_{max}\;and\;T_{max}$, respectively). All of the above parameters met the criteria of KFDA for bioequivalence, indicating that Hana ondansetron tablet is bioequivalent to $Zofran^{TM}$, tablet.

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Bioequivalence of Podox Tablet to Banan Tablet (Cefpodoxime Proxetil 100 mg) (바난 정(세프포독심 프록세틸 100mg)에 대한 포독스 정의 생물학적 동등성)

  • Cho, Seong-Wan;Lee, Ji-Hye;Song, Il-Yong;Lee, Sang-Kil;Cha, Young-Joo;Choi, Young-Wook
    • Journal of Pharmaceutical Investigation
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    • v.29 no.3
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    • pp.241-245
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    • 1999
  • Bioequivalence study of two cefpodoxime preparations, the test drug ($Banan^{\circledR}$: Hanil Pharmaceutical Co., Ltd.) and the reference drug ($Podox^{\circledR}$: Chong Kun Dang Pharmaceutical Co., Ltd.), was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers, $23.8{\pm}2.13$ years old and $63.34{\pm}4.84kg$ of body weight in average, were divided randomly into two groups and administered the drug orally at the dose of 200 mg as cefpodoxime proxetil in a $2{\times}2$ crossover study. Plasma concentrations of cefpodoxime were analysed by HPLC method for 12 hr after administration. The $AUC_{0-12hr}$ was calculated by the linear trapezoidal rule method. The $C_{max}$, and $T_{max}$ were compiled directly from the plasma drug concentration-time data. Student's t-test indicated no significant differences between the formulations in these parameters. Analysis of variance (ANOVA) revealed that there were no differences in AUC, $C_{max}$, and $T_{max}$ between the formulations. The apparent differences between the formulations were far less than 20% (e.g., 4.31, 1.99 and 4.30% for AUC, $C_{max}$, and $T_{max}$, respectively). Minimum detectable differences (%) between the formulations at ${\alpha}=\;0.05$ and $1-{\beta}=\;0.8$ were less than 20% (e.g., 13.89, 13.88, and 16.97% for AUC, $C_{max}$, and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within ${\times}20%$ (e.g., $-5,58{\sim}14.20$, $-7.89{\sim}11.88$, and $-7.78{\sim}16.38%$ for AUC, $C_{max}$, and $T_{max}$, respectively). These results satisfied the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of cefpodoxime were bioequivalent.

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Untersuchungen zur Kohlenstoffloslichkeit in Molybdan und Molybdan-Va-Metall-Legierungen

  • Klaus Schulze;Kim, Hyung-Jin;Hermann Jehn
    • Journal of the Korean institute of surface engineering
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    • v.16 no.3
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    • pp.108-123
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    • 1983
  • 순수 Mo와 Mo-Nb, Mo-Ta($\leq$10 at% Nb. Ta)합금을 1,500-2,06$0^{\circ}C$ 범위에서 탄소의 고용도를 연구하였다. 특수한 침탄방법으로 C2H2를 시편에 침탄한후 열처리하여 부분적으로 석출하거나 완전석출에 관계없는 화학적 분석방법으로 행하였다. 순수 Mo에서 최대탄소 고용도는 logCCmax = 7.02-9,490/T이다. Nb, Ta를 미량첨가하여 탄소의 최대 고용도는 Arrhenius 식을 적용할 수 없다. Nb-, Ta- 농도와 온도에 따라 Mo2C와 Nb-,Ta-를 함유한 여러 가지 탄화물상을 만들거나 $\alpha$고용체와 Mo가 포함된 NbC, TaC와 평형상태를 나타나기 때문이다. 실험온도 범위에서 Nb, Ta를 첨가량을 증가하면 탄화물 내부에 NbC, TaC로 석출된다. 고온에 용해된 a-고용체는 150-200 oK/Min으로 냉각하면 석출물은 결정입계나 결정내부에 나타난다. 순수 Mo에 Nb, Ta를 첨가하여도 경도, 파괴실험에서와 같이 인장강도는 크게 증가하지 않는다.

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Dynamic Economic Load Dispatch Problem Applying Valve-Point Balance and Swap Optimization Method (밸브지점 균형과 교환 최적화 방법을 적용한 동적경제급전문제)

  • Lee, Sang-Un
    • The Journal of the Institute of Internet, Broadcasting and Communication
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    • v.16 no.1
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    • pp.253-262
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    • 2016
  • This paper proposes a balance-swap method for the dynamic economic load dispatch problem. Based on the premise that all generators shall be operated at valve-points, the proposed algorithm initially sets the maximum generation power at $P_i{\leftarrow}P_i^{max}$. As for generator i with $_{max}c_i$, which is the maximum operating cost $c_i=\frac{F(P_i)-F(P_{iv_k})}{(P_i-P_{iv_k})}$ produced when the generation power of each generator is reduced to the valve-point $v_k$, the algorithm reduces i's generation power down to $P_{iv_k}$, the valve-point operating cost. When ${\Sigma}P_i-P_d$ > 0, it reduces the generation power of a generator with $_{max}c_i$ of $c_i=F(P_i)-F(P_i-1)$ to $P_i{\leftarrow}P_i-1$ so as to restore the equilibrium ${\Sigma}P_i=P_d$. The algorithm subsequently optimizes by employing an adult-step method in which power in the range of $_{min}\{_{max}(P_i-P_i^{min}),\;_{max}(P_i^{max}-P_i)\}$>${\alpha}{\geq}10$ is reduced by 10; a baby step method in which power in the range of 10>${\alpha}{\geq}1$ is reduced by 1; and a swap method for $_{max}[F(P_i)-F(P_i-{\alpha})]$>$_{min}[F(P_j+{\alpha})-F(P_j)]$, $i{\neq}j$ of $P_i=P_i{\pm}{\alpha}$, in which power is swapped to $P_i=P_i-{\alpha}$, $P_j=P_j+{\alpha}$. It finally executes minute swap process for ${\alpha}=\text{0.1, 0.01, 0.001, 0.0001}$. When applied to various experimental cases of the dynamic economic load dispatch problems, the proposed algorithm has proved to maximize economic benefits by significantly reducing the optimal operating cost of the extant Heuristic algorithm.

Effect of temperature on pharmacokinetics of nalidixic acid, piromidic acid and oxolinic acid in olive flounder Paralichthys olivaceus following oral administration (넙치, Paralichthys olivaceus에 nalidixic acid, piromidic acid, oxolinic acid의 경구투여 약물동태에 미치는 수온의 영향)

  • Jung, Sung-Hee;Kim, Jin-Woo;Seo, Jung-Soo;Choi, Dong-Lim;Jee, Bo-Young;Park, Myoung-Ae
    • Journal of fish pathology
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    • v.23 no.1
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    • pp.57-67
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    • 2010
  • Effects of temperature ($13{\pm}1.5^{\circ}C$, $23{\pm}1.5^{\circ}C$) on the pharmacokinetic properties of nalidixic acid (NA), piromidic acid (PA) and oxolinic acid (OA) were studied after oral administration to cultured olive flounder, Paralichthys olivaceus. Serum concentrations of these antimicrobials were determined after oral administration of a single dosage of 60 mg/kg body weight (average 700 g). At $23{\pm}1.5^{\circ}C$, the peak serum concentrations of NA, PA and OA, which attained at 10 h, 24 h and 30 h post-dose, were 11.55, 3.79 and $1.12{\mu}g/m\ell$, respectively. At $13{\pm}1.5^{\circ}C$, the peak serum concentrations of NA, PA and OA, which attained at 10 h, 15 h and 30 h post-dose, were 6.36, 1.4 and $1.01{\mu}g/m\ell$, respectively. Better absorption of NA and PA was noted at $23{\pm}1.5^{\circ}C$ compared to $23{\pm}13^{\circ}C$. The elimination of NA from serum of olive flounder was considerably faster at $23{\pm}1.5^{\circ}C$ than at $13{\pm}1.5^{\circ}C$. However, both absorption and elimination of OA were not affected significantly by temperature. The kinetic profile of absorption, distribution and elimination of these antimicrobials in serum were analyzed by fitting to a one- and two compartment model, with WinNonlin program. In the one compartment model for NA, AUC, Tmax and Cmax at $23{\pm}1.5^{\circ}C$ were $258.26{\mu}g{\cdot}h/m\ell$, 10.67 h and $8.91{\mu}g/m\ell$, respectively. The AUC, $T_{max}$ and $C_{max}$ at $13{\pm}1.5^{\circ}C$ were $341.45 {\mu}g{\cdot}h/m\ell$, 7.72 h and $6.23{\mu}g/m\ell$, respectively. In the one compartment model for PA, AUC, $T_{max}$ and $C_{max}$ at $23{\pm}1.5^{\circ}C$ were $248.12{\mu}g{\cdot}h/m\ell$, 21.15 h and $3.09{\mu}g/m\ell$, respectively. The AUC, $T_{max}$ and $C_{max}$ at $13{\pm}1.5^{\circ}C$ were $103.89{\mu}g{\cdot}h/m\ell$, 12.89 h and $1.22{\mu}g/m\ell$, respectively. In the two compartment model for OA, AUC, $T_{max}$ and $C_{max}$ at $23{\pm}1.5^{\circ}C$ were $138.20{\mu}g{\cdot}h/m\ell$, 23.95 h and $1.06{\mu}g/m\ell$, respectively. The AUC, $T_{max}$ and $T_{max}$ at $13{\pm}1.5^{\circ}C$ were $159.10{\mu}g{\cdot}h/m\ell$, 28.03 h and $1.02{\mu}g/m\ell$, respectively.

Bioavailability of Digoxin Tablets in Healthy Volunteers

  • Lee, Chi-Ho;Park, Yun-Ju;Charies-D. Sands;Daniel-W. Jones;John-M. Trang
    • Archives of Pharmacal Research
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    • v.17 no.2
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    • pp.80-86
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    • 1994
  • The bioavailability of digoxin generic tablets manufactures in Korea (formulations A & B) wwere compared to a standard (formulation C; Lanoxin brand digoxin, Burroughs Wellcome, USA) in 12 healthy Korean male volunteers (mean age 31.4 years) in a single dose, randomized, complete block crossover study. Using a latin square design, each of the subjects was randomized to the order number and allocated to each of the three treatments of 0.5mg oral digoxin. Digoxin conc4ntrations in serum and urine samples collected for 48 hours after dosing were measured by fluoprescence polarization immunoassy and radioimmunoassy, respectively. Treatments were compared by using nonlinear least squares regession analysis to evaluate the following pharmacokinetic parameters : maximum serum concentation $(C_{max})$; time of maximum serum concentation $(T_{max})$; area under the serum concentration-time curve $AUC_{0-12}$, $C_{max}$\;and\;(AUC_{0-12})$; and cummulative urinary excretion for 0-48 hours $(CLE_{0-48}.\;Mean\;AUC_{0-12},\;C_{max},\;and\;CUE_{0-48}$ values for formulations B and C were significantly different from formulation A (P<0.001), but not significantly diffeerent form each other. Basede on $AUL_{0-12}\;and\;CUE_{0-48}$ respectively, the relative availability of formulation B was 87.5% and 89.6% and the relative availability of formultation A was 43% and 35% when compared to formulation C(the standard).

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Implementation of Mobile WiMAX Receiver using Mobile Computing Platform for SDR System (모바일 컴퓨팅 플랫폼을 이용한 SDR 기반 MOBILE WIMAX 수신기 구현)

  • Kim, Han Taek;Ahn, Chi Young;Kim, June;Choi, Seung Won
    • Journal of Korea Society of Digital Industry and Information Management
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    • v.8 no.1
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    • pp.117-123
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    • 2012
  • This paper implements mobile Worldwide Interoperability for Microwave Access (WiMAX) receiver using Software Defined Radio (SDR) technology. SDR system is difficult to implement on the mobile handset because of restrictions that are computing power and under space constraints. The implemented receiver processes mobile WiMAX software modem on Open Multimedia Application Platform (OMAP) System on Chip (SoC) and Field Programmable Gate Array (FPGA). OMAP SoC is composed of ARM processor and Digital Signal Processor (DSP). ARM processor supports Single Instruction Multiple Data (SIMD) instruction which could operate on a vector of data with a single instruction and DSP is powerful image and video accelerators. For this reason, we suggest the possibility of SDR technology in the mobile handset. In order to verify the performance of the mobile WiMAX receiver, we measure the software modem runtime respectively. The experimental results show that the proposed receiver is able to do real-time signal processing.

Analysis of Correlation between Sleep Interval Length and Jitter Buffer Size for QoS of IPTV and VoIP Audio Service over Mobile WiMax (Mobile WiMAX에서 IPTV 및 VoIP 음성서비스 품질을 고려한 수면구간 길이와 지터버퍼 크기의 상관관계 분석)

  • Kim, Hyung-Suk;Kim, Tae-Hyoun;Hwang, Ho-Young
    • The KIPS Transactions:PartC
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    • v.17C no.3
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    • pp.299-306
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    • 2010
  • IPTV and VoIP services are considered as killer applications over Mobile WiMAX network, which provideshigh mobility and data rate. Among those which affect the quality of voice in those services, the jitter buffer or playout buffer can compensate the poor voice quality caused by the packet drop due to frequent route change or differences among routes between service endpoints. In this paper, we analyze the correlation between the sleep interval length and jitter buffer size in order to guarantee a predefined level of voice quality. For this purpose, we present an end-to-end delay model considering additional delay incurred by the WiMAX PSC-II sleep mode and a VoIP service quality requirement based on the delay constraints. Through extensive simulation experiments, we also show that the increase of jitter buffer size may degrade the voice quality since it can introduce additional packet drop in the jitter buffer under WiMAX power saving mode.

Bioequivalence of Losazol Tablet to Pletaal Tablet (Cilostazol 50 mg) (프레탈 정(시로스타졸 50 mg)에 대한 로사졸 정의 생물학적 동등성)

  • Kim, Soo-Jin;Lim, Dong-Koo;Oh, In-Joon;Cho, Haeng-Nam;Suh, Soon-Pal;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.28 no.3
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    • pp.193-198
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    • 1998
  • Bioequivalence of two cilostazol tablets, the $Pletaal^{TM}$ (Korea Otsuka Pharmaceutical Co., Ltd.) and the $Losazol^{TM}$ (Kyoung Dong Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Fourteen normal male volunteers (age $20{\sim}28$ years old) were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 50 mg of cilostazol were orally administered, blood was taken at predetermined time intervals and the concentration of cilostazol in plasma was determined with an HPLC method using UV detector. The pharmacokinetic parameters $(C_{max},\;T_{max}\;and\;AUC_t)$ were calculated and ANOVA was utilized for the statistical analysis of parameters. The results showed that the differences in $C_{max},\;T_{max}\;and\;AUC_t$ between two tablets were 3.14%, 10.0% and 7.35%, respectively. The powers $(1-{\beta})$ for $C_{max},\;T_{max}\;and\;AUC_t$ were 89.67%, 80.97% and 83.87%, respectively. Detectable differences $({\Delta})$ and confidence intervals were all less than 20% except $T-{max}$, but confidence interval of $T_{max}$ was also less than 20% at the significance $level({\alpha})$ of 0.1. All of these parameters met the criteria of KFDA for bioequivalence, indicating that $Losazol^{TM}$ tablet is bioequivalent to $Pletaal^{TM} tablet$.

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