• Title/Summary/Keyword: $C_{max}$

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Bioequivalence of Kerora Intramuscular Injections to Tarasyn Intramuscular Injections (Ketorolac Tromethamine 30 mg) (타라신 근주(케토롤락트로메타민 30 mg)에 대한 케로라 근주의 생물학적 동등성)

  • Chung, Youn-Bok;Lee, Jun-Seup;Han, Kun
    • Journal of Pharmaceutical Investigation
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    • v.29 no.1
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    • pp.67-72
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    • 1999
  • A bioequivalence study of the $Kerola^{\circledR}$ intramuscular injections (Dongkwang Pharmaceutical Co., Korea) to the $Tarasyn^{\circledR}$ intramuscular injections (Roche Co., Korea), formulations of ketorolac tromethamine (KTR), was conducted. Sixteen healthy Korean male subjects were received each formulation at the dose of 30 mg as KTR in a $2{\times}2$ crossover study. There was an one-week washout period between the doses. Plasma concentrations of KTR were monitored by a HPLC method. AUC was calculated by the linear trapezoidal method. $C_{max}$ and $T_{max}$ 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 differences between the formulations in these parameters were all far less than 20% (i.e., 3.65, 2.59 and 4.35% for AUC, $C_{max}$ and $T_{max}$ respectively). Minimum detectable differences (%) at ${\alpha}=0.1$ and $1-{\beta}=0.8$ were 12.87, 13.44, 20.62%, for AUC, $C_{max}$ and $T_{max}$, respectively. The 90% confidence intervals for these parameters were also within 20%. These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 1998-86). Therefore, these results indicate that the two formulations of KTR are bioequivalent.

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Pharmacokinetics of Two Cyclosporine Formulations Using FPIA and HPLC Assay in Volunterrs

  • Kwon, Kwang-Il;Kim, Moo-Heon;Park, Jong-Woo;Lee, Chang-Hyun
    • Archives of Pharmacal Research
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    • v.18 no.6
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    • pp.385-390
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    • 1995
  • The analytical methods for the analysis of cyclosporine (CsA), a fluorescence polarization immunoassay (FPIA) and HPLC method, were compared in a pharmacokinetic study of two CsA soft capsule formultaions ($Sandimmun^{\circledR}$; Sandoz, $Implanta^{\circledR}$; Hanmi). Sixteen healthy volunteers completed the study and each subjected single doses ($4{\tiems}100$ mg) of the test and the reference formulations in a two-way crossover design with a one-week drug-free interval between doses. Following each administration, whole blood concentrations of CsA were monitored over a period of 24 hour by both FPIA and HPLC methods. Blood concentrations nad pharmacokinetic parameters determined by either analytical method showed large intersubject variation, with the FPIA data showing relatively higher magnitude of intersubjecte variation than the HPLC data. The blood concentrations determined by FPIA were 1.1-1.3 times higher than those determined by HPLC. There were strong and significant correlations between the two methods (r>0.83 : p<0.0001). Intersubuject variation for the $AUC_{inf}{\;}and{\;}AUC_{24hr}$ of the test formulation was slightly reduced without statistical significance (paried -t test : p>0.05 $t_{max}$ was earlier nad $C_{max}$ was slightly lower for the test formulation, $AUC_{24h}, {\;}C_{max}, {\;}T_{max}$ and MRT determined separately from the data obtained by the two methods for the two formulations were examined by analyses of variance (ANOVA) for the bioequivalency evaluation. Results of ANOVA and confidence limits of terst/reference ratios of $AUC_{24th}$, $C_{max}$, $t_{max}$ and MRT, and statistical tests indicated the bioequivalence of the two formulations (i.e., test/reference ratio was within $100{\times}20%$) except for $C_{max}$ and $t_{max}$. The mean of tmax also showed 11.1% and 9.3% differences but the detection limit were 29.2% and 29.6% as determined by FPIA and HPLC resepctively. This experiments suggest that the data yielded for the two formulations demonstrated that they were bioequivalent.

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Analysis of Cementation Effect on Small Strain Shear Modulus of Sand (사질토의 미소변형 전단탄성계수에 대한 고결영향 분석)

  • Lee, Moon-Joo;Choo, Hyunwook;Choi, Sung-Kun;Lee, Woojin
    • KSCE Journal of Civil and Environmental Engineering Research
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    • v.29 no.2C
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    • pp.51-58
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    • 2009
  • In this study, the small strain shear moduli ($G_{max}$) of uncemented and gypsum-cemented sands are evaluated by performing a series of bender element tests on the specimens reconstituted in the calibration chamber. It is observed from the experimental results that $G_{max}$ of crushed-sands is about 35~50% smaller than that of natural sands. The increase in gypsum content is observed to result in an exponential increase of $G_{max}$ value. It is also shown that the relative density has more significant effect on $G_{max}$ of cemented sand, whereas the vertical effective stress has more significant influence on $G_{max}$ of uncemented one. A prediction equation for cemented sand is expressed as a function of gypsum content as well as void ratio and vertical effective stress.

Transverse relaxation-optimized HCN experiment for tautomeric states of histidine sidechains

  • Schmidt, Holger;Himmel, Sebastian;Walter, Korvin F.A.;Klaukien, Volker;Funk, Michael;Lee, Dong-Han
    • Journal of the Korean Magnetic Resonance Society
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    • v.12 no.2
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    • pp.89-95
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    • 2008
  • Function of protein is frequently related with tautomeric states of histidine sidechains. Thus, several NMR experiments were developed to determine the tautomeric states of histidines. However, poor sensitivity of these experiments caused by long duration of magnetization transfer periods is unavoidable. Here, we alleviate the sensitivity of HCN experiment for determining the tautomeric states of histidine residues using TROSY principle to suppress transverse relaxation of $^{13}C$ spins during long polarization transfer delays involving $^{13}C-^{15}N$ scalar couplings. In addition, this experiment was used to assign the sidechain resonances of histidines. These assignments can be used to follow the pH-titration of histidine sidechains.

Bioequivalence Evaluation of Omeprazole Preparations (오메프라졸을 함유한 울프로정과 로섹캅셀의 생물학적 동등성 평가)

  • Chi, Sang Cheol;Rhee, Yun Seok;Park, Eun Seok
    • Korean Journal of Clinical Pharmacy
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    • v.10 no.2
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    • pp.68-73
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    • 2000
  • The bioequivalence of two omeprazole preparations was evaluated following their oral administration to 16 normal volunteers. The test product was 'Ulpro tablet' made by Boryung Pharmaceutical Co. and the reference was 'Losec capsule' made by Yuhan Corp. After one capsule or tablet containing 20 mg omeprazole was administered, blood was taken at predetermined time intervals and the concentration of the drug in plasma was determined with an HPLC method. AUC and $C_{max}$ were determined and analyzed statistically for the evaluation of bioequivalence of the two products. The differences in AUC and $C_max$ between two products were $0.45\%\;and\;2.83\%$, respectively. The powers for AUC and $C_{max}\;were\;89.2\%\;and\;>90\%$, respectively. Confidence intervals were within $20\%$ for AVC and $C_{max}$All of these parameters met the criteria of KFDA for bioequivalence, indicating that 'Ulpro tablet' is bioequivalent to 'Losee capsule.'

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Mischmetal-FeB-(Co,Ti,Al) Permanent Magnets (Mischmetal-FeB-(Co,Ti,Al) 영구자석)

  • Go, Gwan-Yeong;Yun, Seok-Gil;Kim, Se-Hwan
    • Korean Journal of Materials Research
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    • v.9 no.10
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    • pp.1037-1040
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    • 1999
  • Magnetic characteristics of some anisotropic mischmetal- FeB- (Co,Ti,Al) permanent magnets have been investigated. The magnets were fabricated by using hot-pressed and die-upsetting. Hot-pressed $\textrm{(MM)}_{12.5}\textrm{Fe}_{71.9}\textrm{Co}_{5.0}\textrm{Al}_{2.0}\textrm{B}_{8.6}$ permanent magnet showed $\textrm{H}_{c}$=4.27 kOe, $\textrm{B}_{r}$=4.75 kG, $\textrm{(BH)}_{max}$=3.82 MGOe, and die- upset magnet showed $\textrm{H}_{c}$=3.10 kOe, $\textrm{B}_{r}$=5.58 kG, $\textrm{(BH)}_{max}$=5.34 MGOe, respectively. Hot-pressed $\textrm{(MM)}_{12.5}\textrm{Fe}_{77.9}\textrm{Ti}_{1.0}\textrm{B}_{8.6}$ permanent magnet showed $\textrm{H}_{c}$=3.75 kOe, $\textrm{B}_{r}$=4.64 kG, $\textrm{(BH)}_{max}$=2.78 MGOe, and die- upset magnet showed $\textrm{H}_{c}$=3.29 kOe, $\textrm{B}_{r}$=5.01 kG, $\textrm{(BH)}_{max}$=3.54 MGOe, respectively. X-ray diffraction and transmission electron microscopy revealed that the higher energy products in the die-upset magnets results from alignment of the c-axis along the die-upsetting direction. The magnetic anisotropy in hot-pressed MM-FeB- Al magnet is increased by the substitution of Co for Fe.

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Bioequivalence of Tigrin Capsule to Disgren Capsule (Triflusal 300 mg) (디스그렌 캅셀(트리플루살 300 mg)에 대한 티그린 캅셀의 생물학적 동등성)

  • Kim, Soo-Jin;Shim, Young-Sun;Son, Sun-Mi;Lim, Dong-Koo;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.29 no.4
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    • pp.355-360
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    • 1999
  • Triflusal is a new antithrombotic agent which inhibits both platelet cyclooxygenase and c-AMP phosphodiesterase activity. The purpose of the present study was to evaluate the bioequivalence of two triflusal capsules, $Disgren^{TM}$ (Myung-In Pharmaceutical Co., Ltd.) and $Tigriri^{TM}$ (Hana Pharmaceutical Co., Ltd.) according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $22.94{\pm}1.83$ in age and $63.7l{\pm}10.43$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 300 mg of triflusal was orally administered, blood was taken at predetermined time intervals and the concentrations of triflusal in serum were determined using HPLC method 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 capsules were -0.30%, 0.81 % and -3.03%, respectively when calculated against the $Disgren_{TM}$ capsule. The powers $(1-{\beta})$ for $AUC_t$ $C_{max}$ and $T_{max}$ were 98.29%,84.73% and 81.02%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.1$ and $1-{\beta}=0.8$ were all less than 20% (e.g., 12.91%, 18.46% and 19.65% for $AUC_t$ $C_{max}$ and $T_{max}$ respectively). The 90% confid,ence intervals were all within ${\pm}20%$(e.g., $-8.97{\sim}8.37$, $-11.58{\sim}13.22$ and $-16.23{\sim}10.17$ for $AUC_t$ $C_{max}$ and $T_{max}$, respectively). All of the above parameters ($1-{\beta}, {\Delta}$ and 90% confidence intervals) met the criteria of KFDA for bioequivalence, indicating that $Tigriri^{TM}$ capsule is bioequivalent to $Disgren^{TM}$ capsule.

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The Effect of Different Heat Treatment Processes on Critical Properties of Bi2212/Ag ROSAT Wire (열처리 공정 변화에 따른 Bi2212/Ag ROSAT 선재의 임계 특성)

  • Oh, W.S.;Jang, G.E.;Kim, S.C.;Ha, D.W.;Oh, S.S.
    • Progress in Superconductivity
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    • v.9 no.1
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    • pp.111-114
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    • 2007
  • We have investigated the effect of different heat treatment processes on electrical and magnetic properties of Bi2212/Ag ROSAT wire. The ROSAT wire was fabricated by stacking and arranging 12 filaments Bi2212/Ag tapes in triple rotation symmetry in a Ag tube. ROSAT wires have been prepared using a partial melting method with changing $T_{max}$ and $T_a$ in oxygen atmosphere. The highest critical current density($J_c$) at 65 K under 0 T was $21,158\;A/cm^2$ for wire prepared $890\;^{\circ}C(T_{max})$ and $840\;^{\circ}C(T_a)$, respectively. SEM results indicated that the wire prepared at $890\;^{\circ}C(T_{max})$ and $840\;^{\circ}C(T_a)$ showed better directional phases than the other samples. However the result of magnetic susceptibility measurement indicates that the wire prepared $890\;^{\circ}C(T_{max})$ and $835\;^{\circ}C(T_a)$ had better superconducting phases than the other samples. It was revealed that heat treatment temperature was important factor for superconducting properties of the ROSAT wire.

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Evaluation of Material Characteristics with Sintering Temperature in Ti2AlC MAX Phase Material using Spark Plasma Sintering Method (방전플라즈마 소결법을 이용한 Ti2AlC Max Phase 소결체의 소결온도 변화에 따른 재료 특성 평가)

  • Lee, Chang-Hun;Baek, Gyung Rae;Jung, Hee Sang;Jeong, Young-Keun;Kang, Myung Chang
    • Journal of Powder Materials
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    • v.22 no.3
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    • pp.175-180
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    • 2015
  • In this study, ternary compound Max Phase $Ti_2AlC$ material was mixed by 3D ball milling as a function of ball milling time. More than 99.5 wt% pure $Ti_2AlC$ was synthesized by using spark plasma sintering method at 1000, 1100, 1200, and $1300^{\circ}C$ for 60 min. The material characteristics of synthesized samples were examined with relative density, hardness, and electrical conductivity as a function of sintering temperature. The phase composition of bulk was identified by X-ray diffraction. On the basis of FE-SEM result, a terraced structures which consists of several laminated layers were observed. And $Ti_2AlC$ bulk material obtained a vickers hardness of 5.1 GPa at the sintering temperature of $1100^{\circ}C$.