• Title/Summary/Keyword: $C_{max}$

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Bioequivalence of Cisaplus Tablets to Prepulsid Tablets (Cisapride 5 mg) (프레팔시드 정 (시사프리드 5 mg)에 대한 시사프러스 정의 생물학적 동등성)

  • Yoo, Sun Dong;Jun, Hun;Shin, Beom Soo;Park, Joon Woo;Kim, Hak Hyung
    • Korean Journal of Clinical Pharmacy
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    • v.10 no.1
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    • pp.25-29
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    • 2000
  • Bioequivalence of cisapride-containing $Cisaplus^{(R)}$ tablets (Daewoong Co.) to reference $Prepulsid^{(R)}$ tablets (Janssen Co.) was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy volunteers were divided randomly into two groups and administered orally at a cisapride dose of 10 mg in a $2\times2$ crossover design. There was a 1-week washout period between the treatments. Blood samples were taken at predetermined time intervals for 48 hr and the plasma cisapride concentrations were determined by an HPLC with UV detector. The area under the plasma drug concentration-time curve (AUC) was caltulated from time zero to the last sampling time by a linear trapezoidal method. The maximum observed plasma drug concentration ($C_{max}$) and the time to $C_{max}\;(T_{max})$ were estimated directly from the drug concentration-time data. Analysis of variance (ANOVA) showed that the apparent differences for AUC, $C_{max}\;and\;T_{max}$ were $-7.52\%,\;-8.91\%\;and\;-15.55\%$, respectively. The minimum detectable differences for AUC, $C_{max}\;and\;T_{max}$ between formulations were $14.52\%,\;11.57\%\;and\;28.00\%$ respectively, at $\alpha=0.05\;and\;1-\beta=0.8\;levels.\;The\;90\%$ confidence intervals for AUC, $C_{max}\;and\;T_{max}\;were\;-16.00\sim0.97\%,\;-15.67\sim-2.15\%\;and\;-31.88\%\sim0.84\%$, respectively. These results satisfy the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of cisapride are bioequivalent.

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Optimization of Synthesis Conditions for Improving Ti3AlC2 MAX Phase Using Titanium Scraps (타이타늄 스크랩 활용 Ti3AlC2 MAX 상분율 향상을 위한 합성 조건 최적화)

  • Taeheon Kim;Jae-Won Lim
    • Resources Recycling
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    • v.33 no.1
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    • pp.22-30
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    • 2024
  • To synthesize the Ti3AlC2 MAX phase, a crucial precursor for generating the two-dimensional material MXene, the use of Ti scrap as an initial material is an economically feasible approach. This study aims to optimize the synthesis conditions for the phase fraction of the Ti3AlC2 MAX phase utilizing Ti scrap as the Ti source. The deoxidation of Ti powders, prepared through the hydrogenation-dehydrogenation process from Ti scrap, was effectively accomplished using the deoxidation in solid-state (DOSS) process. The optimal synthesis conditions were established by blending DOSS-Ti, Al, and graphite powders with particle sizes ranging from 25 ~ 32 ㎛ in a molar ratio of 3:1.1:2. The resulting phase fractions were as follows: Ti3AlC2 at 97.25 wt.%, TiC at 0.93 wt.%, and Al3Ti at 1.82 wt.%. Furthermore, the oxygen content of the Ti3AlC2 MAX powder, spanning from 25 ~ 45 ㎛, was measured at 4,210 ppm.

The Pharmacokinetics of Erythromycin in Cultured Paralichthys olivaceus after Oral administration (경구투여에 의한 양식산 넙치내 Erythromycin의 약물동태학적 특성 분석)

  • Seo, Jung-Soo;Jeon, Eun-Ji;Jung, Sung-Hee;Park, Myung-Ae;Kim, Na-Young
    • Journal of Fisheries and Marine Sciences Education
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    • v.26 no.2
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    • pp.316-321
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    • 2014
  • The pharmacokinetics of erythromycin (EM) after oral administration was studied in the cultured olive flounder, Paralichthys olivaceus, using LC/MS/MS. After single- or multiple-dose administration of EM (50, 100, 200 mg/kg body weight and 50 mg/kg for 5 days) by oral route in olive flounder ($350{\pm}40g$, $22{\pm}0.5^{\circ}C$), the concentration in the serum was determined at 1, 3, 6, 9, 24, 72, 120, 168, 264, 360, 504 and 720 h post-dose. The kinetic profile of absorption, distribution and elimination of EM in serum were analyzed fitting to a two-compartment model by WinNonlin program. The area under the concentration-time curve (AUC), maximum concentration ($C_{max}$), time for maximum concentration ($T_{max}$) following oral administration of 50, 100 and 200 mg/kg b.w. and 50 mg for 5 days. EM was $165.3hr^*{\mu}g/m{\ell}$ ($C_{max}$, $34.63{\mu}g/m{\ell}$; $T_{max}$, 1.56 hr), $212.8hr^*{\mu}g/m{\ell}$ ($C_{max}$, $60.38{\mu}g/m{\ell}$; $T_{max}$, 3.99 hr), and $592.37hr^*{\mu}g/m{\ell}$ ($C_{max}$, $63.01{\mu}g/m{\ell}$; $T_{max}$, 4 hr), respectively. The results of this study related to dosage and ${\mu}{\cdot}$withdrawal times could be used for prescription of EM in field for the treatment of bacterial diseases in olive flounder.

Feeding of Juvenile Purple Washington Clam, Saxidomus purpuratus (Sowerby): Effects of Algal Concentration and Temperature

  • Lee, Chang-Hoon;Choi, Yong-Suk;Bang, Jong-Deuk;Jo, Soo-Gun
    • Journal of Aquaculture
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    • v.15 no.4
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    • pp.253-260
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    • 2002
  • To find the optimal rearing conditions for Saxidomus purpuratus juvenile, filtering activity was estimated as functions of algal concentration and temperature by measuring the rates of clearance (CR) and ingestion (IR), when S. purpuratus was feeding. The clams were fed on unialgal diet of Isochrysis galbana at 6 algal concentrations (4.6$\times$$10^4$~2.6$\times$$10^6$ cells/ml) and at 6 temperatures (5, 10, 15, 20, 25, and 30^{\circ}C ). Algal concentration significantly affected the CR and the IR at all temperatures. At lower algal concentrations, CR increased, but decreased beyond a particular concentration. The maximum CR ($CR_{max}$) at 5, 10, 15, 20, 25, and 30^{\circ}C were 0.30, 1.73, 5.95, 15.17, 21.12, and 0.33 $l/g/h$, respectively. Below the level of 5.6$\times$10$^{5}$ cells/ml, IR increased as algal concentration increased, but was saturated at higher concentrations. To maintain high growth rate of S. purpuratus, I. galbana should be supplied with more than 5.6$\times$10$^{5}$ cells/ml. The maximum IR ($IR_{max}$) at 5, 10, 15, 20, 25 and30^{\circ}C were $2.2$\times$10^8, $1.5\times$10^9, 3.4$\times$10^9, 4.9$\times$10^9, 5.3$\times$10^9, and 1.0$\times$10^8$ cells/g/h, respectively. As for temperature, both $CR_max$ and $IR_max$ increased remarkably with raising temperature from 5 to 25^{\circ}C, but rapidly decreased at 30^{\circ}C. Between 15 and 25^{\circ}C $CR_{max} and IR_{max}$ were higher and most stable, At this temperature range, the $Q_{10}/s for CR_{max} and IR_{max}$ were 3.5 and 1.6, respectively. Therefore the optimal thermal range for the juvenile is 15~$25^{\circ}C$. The annual variation in IR$_{max}$ predicted by natural seawater temperature shows that inactive period (with lower $IR_max$) lasts for 5 months (from December to April). To ensure higher growth of juvenile during this inactive period at hatcheries, rearing temperature should be elevated to $15^{\circ}C$.>.

A Time Series Analysis on Urban Weather Conditions for Constructing Urban Integrated Energy System (차세대에너지시스템 구축을 위한 도시기상조건 시계열분석)

  • Kim, Sang-Ok;Han, Kyung-Min;Yee, Jurng-Jae;Yoon, Seong-Hwan
    • 한국태양에너지학회:학술대회논문집
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    • 2009.11a
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    • pp.26-31
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    • 2009
  • This study was analysed influence of urban higher temperature in Busan about time series analysis of AWS data. The results are as follows. (1) The temperature of Busan show min $13.2^{\circ}C$ ~max $15.8^{\circ}C$ by 50 years, it is on the rise. (2) The seasonal adjustment series, summer appeared min $17.5^{\circ}C$ ~max $28.9^{\circ}C$ with primitive series similarly. The winter was min $-11.4^{\circ}C$ ~max $17.9^{\circ}C$, the minimum temperature was more lowly than primitive series and maximum temperature was more higher than primitive series. The results, seasonal adjustment series is guessed with influence difference urban structural element beside seasonal factor. (3) Regional analytical result, January appeared with range of min 28% ~max 196% of the seasonal factor and August appeared min 90% ~ max 106%. One of the case which is of 100% or more of the seasonal factor January 12nd~17th, August appears at the 15~17th.

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Bioequivalence of Dong Sung Lovastatin Tablet to Mevacor Tablet (Lovastatin 20 mg) (메바코정(로바스타틴 20 mg)에 대한 동성로바스타틴정의 생물학적 동등성)

  • 최민구;최미희;김경식;김인화;이영주
    • YAKHAK HOEJI
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    • v.45 no.2
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    • pp.220-226
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    • 2001
  • A bioequivalence study of Lovastati $n^{TM}$ tablets (Dong Sung Pharmaceutical Co., Korea) to Mevaco $r^{TM}$ tablets (Choong Wae Pharmaceutical Co., Korea) was conducted according to the guidelines (No. 98-56) of Korea Food and Drug Administration (KFDA). Each tablet contained 20 mg of lovastatin. Eighteen healthy Korean male subjects received each formulation at a lovastatin dose of 80 mg (i.e., four tablets) in a 2 $\times$ 2 crossover study. There was a washout period of a week between the dose of the two formulations. Plasma concentrations of lovastatin acid were monitored by a GC/MS method for over a period of 12hr after each administration. The area under the plasma concentration-time curve from time zero to 12hr (AUC) was calculated by a linear trapezoidal method. The maximum plasma drug concentration ( $C_{max}$) and the time to reach $C_{max}$ ( $T_{max}$) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) of these parameters revealed that there are no differences in AUC and $C_{max}$ between the formulations. The apparent differences between the formulations in these parameters were 4.87 and 8.03% for AUC and $C_{max}$, respectively. Minimum detectable differences (%) at $\alpha$=0.1 and 1-$\beta$=0.8 were 17.84 and 15.36% for AUC and $C_{max}$ respectively. The 90% confidence intervals were -15.30~5.56 and -17.02-0.95% for AUC and $C_{max}$, respective1y. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Mevaco $r^{TM}$ tablets and Dong Sung Lovastati $n^{TM}$ tablets are bioequivalent.ivalent.ent.alent.ent.

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STRUCTURE OF THE SPIRAL GALAXY NGC 300 -1. The generalzation of Toomre's mass model-

  • Rhee, Myung-Hyun;Chun, Mun-Suk
    • Journal of Astronomy and Space Sciences
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    • v.9 no.1
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    • pp.11-29
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    • 1992
  • In 1963, Toomre built up classes of mass models for the highly flattened galaxies which have free parameters n, $a_n$ and $C_n$. In order to keep the universal dimension, we adopt parameters $b_n({C_n}^2={a_n}^{2n}+^2{b_n}^2/(n-1)!)$ insteal of $C_n$. Series of the normalized Toomre's mass models (G = $V_{max}$ =$R_{max}$ = 1, n = 1 to 7) are derived and the normalized parameters $a_n$ and $b_n$ are determined by the iteration method. Replacing parameters $a_n$ and $b_n$ to ${a_n}^l(=a_nr_{max})$ and ${b_n}^l(=b_n\cdotV_{max}/r_{max})$, we can get the generalization of Toomre's mass model.

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Bioequivalence of Loxipen Tablet to Loxonin Tablet (Sodium Loxoprofen Anhydride 60 mg) (록소닌 정(록소프로펜 나트륨 무수물 60 mg)에 대한 록시펜 정의 생물학적 동등성)

  • Kim, In-Wha;Han, Tae-Gyu;Kim, Kyung-Sik;Chung, Suk-Jae;Lee, Min-Hwa;Shim, Chang-Koo
    • Journal of Pharmaceutical Investigation
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    • v.28 no.3
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    • pp.185-191
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    • 1998
  • A bioequivalence study of the Loxipen tablets (Dae Wha Pharmaceutical Co., Korea) to the Loxonin tablets (Dong Hwa Pharmaceutical Co., Korea), formulations of sodium loxoprofen anhydrous 60 mg, was conducted. Sixteen healthy Korean male subjects received each formulation at the dose of 60 mg as sodium loxoprofen anhydrous in a $2{\times}2$ crossover study. There was a 2-week washout period between the dose. Plasma concentrations of loxoprofen were monitored by an HPLC method for over a period of 6 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., 5.88, 7.81 and 6.09% for AUC, $C_{max}$ and $T_{max}$, respectively). Minimum detectable differences (%) at ${\alpha}=0.1$ and $1-{\beta}=0.8$ were all less than 20% difference in these parameters between the formulations were all over 0.8 (i.e., 15.81, 13.13 and 19.85 for AUC, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within ${\pm}20%$ (i.e., $-16.52{\sim}4.77$, $-16.65{\sim}1,02$ and $-19.45{\sim}7.28%$ 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 2 formulations of loxoprofen are bioequivalent and, thus, may be prescribed interchangeably.

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Initiation and Growth Behavior of Small Surface Fatigue Crack in SiC Reinforced Aluminum Composite (SiC 강화 알루미늄기 복합재료의 표면미소 피로균열 발생 및 진전 거동)

  • Lee, Sang-Hyoup;Choi, Young-Geun;Kim, Sang-Tae
    • Composites Research
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    • v.22 no.3
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    • pp.74-81
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    • 2009
  • Reversed plane bending fatigue tests were conducted on SiC particle reinforced and SiC whisker reinforced aluminum composite. The initiation and growth behaviors of small surface fatigue cracks were continuously monitored by the replica technique and the causes of fracture and fracture mechanism were investigated by SEM. The relationship between da/dn and $K_{max}$ show that da/dn increases in high stress level while decrease and again increases with increasing of $K_{max}$ in low stress level for two materials.

Bioequivalence of Terasin Tablet to Hytrine Tablet (Terazosin 2 mg) (하이트린 정(테라조신 2 mg)에 대한 테라신 정의 생물학적 동등성)

  • Kim, Soo-Jin;Lim, Dong-Koo;Oh, In-Joon;Shin, Sang-Chul;Park, Haeng-Soon;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.29 no.1
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    • pp.61-66
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    • 1999
  • Bioequivalence of two terazosin tablets, the $Hytrine^{TM}$ (Il-Yang Pharmaceutical Co., Ltd.) and the $Hytrine^{TM}$ (Daewon Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Sixteen normal male volunteers $(21{\sim}30\;years\;old)$ were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 2 mg of terazosin was orally administered, blood was taken at predetermined time intervals and the concentration of terazosin in serum was determined with a HPLC method using spectrofluorometric detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\;T_{max})$ were calculated and ANOVA 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 6.02%,3.44% and -3.67%, respectively. The powers $(1-{\beta})$ for $AUC_t$, $C_{max}$ and $T_{max}$ were 98.05%, 98.34% and 29.81 %, respectively. Detectable differences $({\Delta})$ and confidence intervals were all less than ${\pm}20%$ except $T_{max}$. $AUC_t$ and $C_{max}$ met the criteria of KFDA for bioequivalence, indicating that $Terasin^{TM}$ tablet is bioequivalent to $Hytrine^{TM}$ tablet.

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