• Journal of Pharmaceutical Investigation
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• 제29권1호
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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.

• Archives of Pharmacal Research
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• 제18권6호
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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.

• 대한토목학회논문집
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• 제29권2C호
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• pp.51-58
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• 2009

본 연구에서는 챔버에 조성된 미고결, 고결모래에 대한 벤더엘리먼트 시험으로부터 사질토 미소변형 전단탄성계수인 $G_{max}$를 평가하였다. 시험결과, 본 연구에서 사용된 파쇄모래의 $G_{max}$는 기존의 연구에 사용된 자연상태 모래의 $G_{max}$보다 35~50% 작게 평가되었으나, 고결모래의 $G_{max}$는 이전 연구 결과보다 크게 평가되었다. 모래의 $G_{max}$는 고결유발제로 사용된 석고의 함유율에 가장 큰 영향을 받았으며, 석고함유율에 따라 지수적으로 증가하였다. 상대밀도의 증가는 미고결 모래보다 고결모래의 $G_{max}$ 증가에 더 큰 영향을 미치는 것으로 관찰되었으며, 유효연직응력의 증가는 고결모래의 $G_{max}$보다 미고결 모래의 $G_{max}$ 증가에 더 큰 영향을 미쳤다. 이와 같은 영향요인 분석을 바탕으로 고결모래의 $G_{max}$를 간극비, 유효연직구속압 뿐만 아니라 석고함유율에 따른 함수로 표현하였다.

• 한국자기공명학회논문지
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• 제12권2호
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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.

• 한국임상약학회지
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• 제10권2호
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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.'

• 한국재료학회지
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• 제9권10호
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• pp.1037-1040
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• 1999

열간압축 및 다이업셋한 Mischmetal-FeB-(C0,Ti,Al) 영구자석의 자기적 특성과 미세조직을 시료진동형 자력계, 투과전자 현미경, 주사전자 현미경, X-선 회절기를 이용하여 조사하였다. $\textrm{(MM)}_{12.5}\textrm{Fe}_{71.9}\textrm{Co}_{5.0}\textrm{Al}_{2.0}\textrm{B}_{8.6}$조성의 열간압축 자석은 $\textrm{H}_{c}$=4.27 kOe, $\textrm{B}_{r}$=4.75 kG, $\textrm{(BH)}_{max}$=3.82 MGOe의 특성을 보였다. 다이업셋 자석은 $\textrm{H}_{c}$=3.10 kOe, $\textrm{B}_{r}$=5.58 kG, $\textrm{(BH)}_{max}$=5.34 MGOe의 특성을 나타냈다. $\textrm{(MM)}_{12.5}\textrm{Fe}_{77.9}\textrm{Ti}_{1.0}\textrm{B}_{8.6}$ 조성의 경우, 열간압축 자석은 $\textrm{H}_{c}$=3.75 kOe, $\textrm{B}_{r}$=4.64 kG, $\textrm{(BH)}_{max}$=2.78 MGOe, 다이업셋 자석은 $\textrm{H}_{c}$=3.29 kOe, $\textrm{B}_{r}$=5.01 kG, $\textrm{(BH)}_{max}$=3.54 MGOe의 특성을 보였다. X-선 회절 및 투과전자 현미경 조사결과에 의하면, 다이업셋 자석에서 c축이 다이업셋 방향으로 놓이는 결정이방성이 나타나며, 이는 다이어셋 자석의 에너지적의 증가와 관련이 있는 것으로 보인다. Co의 Fe에 대한 일부 치환은 열간압축자석의 자기이방성을 증가시키는 것으로 나타났다.

• 한국자기학회:학술대회 개요집
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• 한국자기학회 2007년도 The 1st International Symposium on Advanced Magnetic Materials
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• pp.229.2-229.2
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• 2007

• Journal of Pharmaceutical Investigation
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• 제29권4호
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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.

• Progress in Superconductivity
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• 제9권1호
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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.

• 한국분말재료학회지
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• 제22권3호
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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 $1100^{\circ}C$.