• 제목/요약/키워드: $C_{max}{\

검색결과 1,797건 처리시간 0.031초

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

  • 조혜영;김수진;심영순;임동구;오인준;문재동;이용복
    • Journal of Pharmaceutical Investigation
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    • 제30권1호
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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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조프란 정(온단세트론 8 mg)에 대한 하나 온단세트론 정의 생물학적 동등성 (Bioequivalence of Hana Ondansetron Tablet to Zofran Tablet (Ondansetron 8 mg))

  • 조혜영;김수진;심영순;임동구;오인준;문재동;이용복
    • Journal of Pharmaceutical Investigation
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    • 제30권3호
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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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바난 정(세프포독심 프록세틸 100mg)에 대한 포독스 정의 생물학적 동등성 (Bioequivalence of Podox Tablet to Banan Tablet (Cefpodoxime Proxetil 100 mg))

  • 조성완;이지혜;송일용;이상길;차영주;최영욱
    • Journal of Pharmaceutical Investigation
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    • 제29권3호
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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
    • 한국표면공학회지
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    • 제16권3호
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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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밸브지점 균형과 교환 최적화 방법을 적용한 동적경제급전문제 (Dynamic Economic Load Dispatch Problem Applying Valve-Point Balance and Swap Optimization Method)

  • 이상운
    • 한국인터넷방송통신학회논문지
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    • 제16권1호
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    • pp.253-262
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    • 2016
  • 본 논문은 경제급전 최적화 문제에 균형-교환 방법을 제안하였다. 제안된 알고리즘은 모든 발전기를 가능한한 밸브지점으로 운영한다고 가정한다. 초기치로 최대 발전량 $P_i{\leftarrow}P_i^{max}$로 설정하고, 각 발전기의 밸브지점 $v_k$까지 발전량을 감소시켰을 때의 평균 발전단가 $c_i=\frac{F(P_i)-F(P_{iv_k})}{(P_i-P_{iv_k})}$가 최대가 되는 $_{max}c_i$ 발전기 i의 발전량을 밸브지점 발전단가 $P_{iv_k}$로 감소시켰으며, ${\Sigma}P_i-P_d$ > 0이면 $c_i=F(P_i)-F(p_i-1)$$_{max}c_i$ 발전기 발전량을 $P_i{\leftarrow}P_i-1$로 감소시켜 ${\Sigma}P_i=P_d$의 균형을 맞추었다. 다음으로, $_{min}\{_{max}(P_i-P_i^{min}),\;_{max}(P_i^{max}-P_i)\}$>${\alpha}{\geq}10$의 범위에 대해 "-10" 간격으로 감소시키는 성인걸음법으로, 10>${\alpha}{\geq}1$ 범위에 대해서는 "-1"의 아기걸음법으로, $P_i=P_i{\pm}{\alpha}$에 대한 $_{max}[F(P_i)-F(P_i-{\alpha})]$>$_{min}[F(P_j+{\alpha})-F(P_j)]$, $i{\neq}j$이면 $P_i=P_i-{\alpha}$, $P_j=P_j+{\alpha}$로 발전량을 교환하는 방법으로 최적화를 수행하였다. 다음으로 ${\alpha}=\text{0.1, 0.01, 0.001, 0.0001$에 대해 미세한 교환을 수행하였다. 동적 경제급전 문제의 시험 사례에 제안된 알고리즘을 적용한 결과 기존의 휴리스틱 알고리즘 최적화 발전비용을 크게 감소시켜 경제적인 이익을 극대화 시켰다.

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

  • 정승희;김진우;서정수;최동림;지보영;박명애
    • 한국어병학회지
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    • 제23권1호
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    • pp.57-67
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    • 2010
  • 퀴놀론계 항균제인 nalidixic acid(OA), piromidic acid(PA), oxolinic acid(OA)를 사육수온($13{\pm}1.5^{\circ}C$, $23{\pm}1.5^{\circ}C$)에 따라서 넙치(평균체중 700 g)에 60 mg/kg의 농도로 1회 경구 투여한 다음, 경시적인 혈청내 잔류농도를 분석하였다. 수온이 $23{\pm}1.5^{\circ}C$의 경우, 투여 후 NA는 10시간째 ($11.55{\mu}g/m\ell$), PA는 24시간째($3.79{\mu}g/m\ell$), OA는 30시간째($1.12{\mu}g/m\ell$)에 각각 최대혈중농도에 도달하였다. 수온이 $13{\pm}1.5^{\circ}C$의 경우, 투여 후 NA는 10시간째($6.36{\mu}g/m\ell$), PA는 15시간째($1.4{\mu}g/m\ell$), OA는 30시간째($1.01{\mu}g/m\ell$)에 각각 최대혈중농도에 도달하였다. NA와 PA의 넙치 혈중내 흡수정도는 수온 $13{\pm}1.5^{\circ}C$보다 수온 $23{\pm}1.5^{\circ}C$에서 매우 높게 나타났으며, NA의 넙치 혈중내 소실정도는 수온 $13{\pm}1.5^{\circ}C$보다 수온 $23{\pm}1.5^{\circ}C$에서 두드러지게 빨랐다. 한편 OA의 넙치 혈중내 흡수 및 소실정도는 사육수온에 크게 영향을 받지 않는 것으로 나타났다. NA 및 PA는 one-compartment model, OA는 two-compartment model로 해석하여 WinNonlin program을 이용, 약물동태학적 매개변수(parameter)를 조사하였다. 수온이 $23{\pm}1.5^{\circ}C$의 경우, 혈장농도-시간곡선하 면적(AUC)은 NA, PA, OA가 각각 258.26, 248.12 및 $138.20{\mu}g{\cdot}h/m\ell$, 혈중최고농도의 도달시간($T_{max}$)은 10.67, 21.15 및 23.95 h, 혈중최고농도($C_{max}$)는 8.91, 3.09 및 $1.06{\mu}g/m\ell$로 계산되었다. 수온이 $13{\pm}1.5^{\circ}C$의 경우, AUC는 NA, PA, OA가 각각 341.45, 103.89 및 $159.10{\mu}g{\cdot}h/m\ell$, 혈중최고농도의 도달시간은 7.72, 12.89 및 28.03 h, 혈중최고농도는 6.23, 1.22 및 $1.02{\mu}g/m\ell$로 계산되었다.

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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    • 제17권2호
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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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모바일 컴퓨팅 플랫폼을 이용한 SDR 기반 MOBILE WIMAX 수신기 구현 (Implementation of Mobile WiMAX Receiver using Mobile Computing Platform for SDR System)

  • 김한택;안치영;김준;최승원
    • 디지털산업정보학회논문지
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    • 제8권1호
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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.

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

  • 김형석;김태현;황호영
    • 정보처리학회논문지C
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    • 제17C권3호
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    • pp.299-306
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    • 2010
  • IPTV 및 VoIP 서비스는 높은 이동성과 전송 속도를 보장하는 Mobile WiMAX 네트워크 상에서 제공할 수 있는 유용한 응용 서비스들이다. IPTV의 오디오 전송이나 VoIP의 통화 품질에 영향을 미치는 요소 중 전송 경로의 잦은 변경이나 경로간 전송 시간의 차이에 따라 발생하는 지터에 의한 패킷 손실은 지터 버퍼를 이용하여 완화할 수 있다. 본 논문에서는 Mobile WiMAX 네트워크 상에서 이동 단말의 전력 소모 절감을 위해 사용되는 PSC-II 모드를 사용할 때의 오디오 및 음성 서비스의 품질(Quality of Service)과 지터 버퍼 크기의 상관관계에 대해 연구, 분석한다. 이를 위해 절전 모드 사용으로 인해 추가로 발생하는 지연 시간을 포함한 서비스의 종단간 지연시간 모델과 종단간 지연시간을 기준으로 한 서비스 품질 기준을 제시하였다. 또한, 제시한 모델의 다양한 파라미터에 따른 시뮬레이션 분석 결과를 통해 절전 모드를 사용할 경우에는 지터 버퍼의 크기 증가에 따른 지연으로 인한 패킷 손실이 오히려 오디오 및 VoIP 서비스 품질 측면에서 좋지 않은 영향을 미칠 수 있음을 보였다.

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

  • 김수진;임동구;오인준;조행남;서순팔;이용복
    • Journal of Pharmaceutical Investigation
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    • 제28권3호
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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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