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Preparation and Bioequivalence Test of Acetaminophen Liquid Suppository (아세트아미노펜 액상좌제의 제초 및 생물학적 동등성 평가)

  • 김종국;최한곤;이사원;고종호;이미경
    • Biomolecules & Therapeutics
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    • v.6 no.2
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    • pp.213-218
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    • 1998
  • A novel in situ-gelling and mucoadhesive acetaminophen liquid suppository was developed to improve the patient compliance of conventional solid suppository. In this study, acetaminophen liquid suppository, Likipe $n_{R}$, [aminophen/Poloxamer 407/Poloxamer 188/so4ium alginate (5/15/19/0.6%)] with relation temperature at 30-36 "C and suitable gel strength and bioadhesive force, dissolution pattern similar to conventional solid type suppository, Suspe $n_{R}$, was developed. Furthermore, the bioequivalence of two acetaminophen products was evaluated in 16 normal male volunteers (age 22-27 yr, body weight 56-72 kg) following sidle rectal administration. Test product was Likipe $n_{R}$ suppository (Dong-Wha Pharm. Corp., Korea)and reference product was Suspe $n_{R}$204-212 suppository (Hanmi Pharm. Corp., Korea). Both products contain 125 mg of acetaminophen. Four Suppositories of the test and the reference product were administered to the volunteers, respectively, by randomized two period cross-over study (2$\times$2 Latin square method). The determination of acetaminophen was accomplished using HPLC. Average drug concentrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products (p>0.05); the area under the curve to last sampling time (24 hr) (AU $Co_{-2}$4h/) (30.14$\pm$8.64 vs 27.98$\pm$ 6.53 $\mu$g .h/ml), maximum plasma concentration ( $C_{max}$) (3.29$\pm$0.87 vs 3.60$\pm$0.66 $\mu$g/ml) and time to maximum plasma concentration ( $T_{max}$) (2.91 $\pm$0.55 vs 2.69$\pm$0.60 h). The differences of mean AUCo $_{24h}$, C-a. and T-between the two products (7.18%, 9.58% and 7.53%, respectively) were less than 20%. The power (1-7) and treatment difference ($\Delta$) for AU $Co_{24h}$, $C_{max}$ and $T_{max}$ were more than 0.8 and less than 0.2, respectively at $\alpha$=0.1. The confidence limits for AU $Co_{24h}$, $C_{max}$ and $T_{max}$ (-0.81 ~13.55%, -1.56~ 17.60 and -3.81 ~18.87%, respectively) were less than $\pm$ 20% at $\alpha$=0.1. These results suggest that the bioavailability of Likipe $n_{R}$ suppository is not significantly different from that of Suspe $n_{R}$ suppsitory. Therefore, two products are bio-equivalent based on the current results.results.lts.sults.results.lts.

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Tensile strength of bilayered ceramics and corresponding glass veneers

  • Anunmana, Chuchai;Champirat, Tharee;Jirajariyavej, Bundhit
    • The Journal of Advanced Prosthodontics
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    • v.6 no.3
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    • pp.151-156
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    • 2014
  • PURPOSE. To investigate the microtensile bond strength between two all-ceramic systems; lithium disilicate glass ceramic and zirconia core ceramics bonded with their corresponding glass veneers. MATERIALS AND METHODS. Blocks of core ceramics (IPS e.max$^{(R)}$ Press and Lava$^{TM}$ Frame) were fabricated and veneered with their corresponding glass veneers. The bilayered blocks were cut into microbars; 8 mm in length and $1mm^2$ in cross-sectional area (n = 30/group). Additionally, monolithic microbars of these two veneers (IPS e.max$^{(R)}$ Ceram and LavaTM Ceram; n = 30/group) were also prepared. The obtained microbars were tested in tension until fracture, and the fracture surfaces of the microbars were examined with fluorescent black light and scanning electron microscope (SEM) to identify the mode of failure. One-way ANOVA and the Dunnett's T3 test were performed to determine significant differences of the mean microtensile bond strength at a significance level of 0.05. RESULTS. The mean microtensile bond strength of IPS e.max$^{(R)}$ Press/IPS e.max$^{(R)}$ Ceram ($43.40{\pm}5.51$ MPa) was significantly greater than that of Lava$^{TM}$ Frame/Lava$^{TM}$ Ceram ($31.71{\pm}7.03$ MPa)(P<.001). Fluorescent black light and SEM analysis showed that most of the tested microbars failed cohesively in the veneer layer. Furthermore, the bond strength of Lava$^{TM}$ Frame/Lava$^{TM}$ Ceram was comparable to the tensile strength of monolithic glass veneer of Lava$^{TM}$ Ceram, while the bond strength of bilayered IPS e.max$^{(R)}$ Press/IPS e.max$^{(R)}$ Ceram was significantly greater than tensile strength of monolithic IPS e.max$^{(R)}$ Ceram. CONCLUSION. Because fracture site occurred mostly in the glass veneer and most failures were away from the interfacial zone, microtensile bond test may not be a suitable test for bonding integrity. Fracture mechanics approach such as fracture toughness of the interface may be more appropriate to represent the bonding quality between two materials.

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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A Fast Algorithm for an Extension of the Multiple Choice Linear Knapsack Problem (확장된 다중선택 선형배낭문제의 신속한 해법연구)

  • Won, Joong-Yeon
    • Journal of Korean Institute of Industrial Engineers
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    • v.22 no.3
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    • pp.365-375
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    • 1996
  • We consider an extension of the multiple choice linear knapsack problem and develop a fast algorithm of order $O(r_{max}n^2)$ by exploiting some new properties, where $r_{max}$ is the largest multiple choice number and n is the total number of variables. The proposed algorithm has convenient structures for the post-optimization in changes of the right-hand-side and multiple choice numbers. A numerical example is presented.

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A Fast Algorithm for the Generalized Multiple Choice Linear Knapsack Problem (일반 다중선택 선형배낭문제의 신속한 해법연구)

  • Won, Joong-Yeon
    • Journal of Korean Institute of Industrial Engineers
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    • v.21 no.4
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    • pp.519-527
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    • 1995
  • By finding some new properties, we develop an O($r_{max}n^2$) algorithm for the generalized multiple choice linear knapsack problem where $r_{max}$ is the largest multiple choice number and n is the total number of variables. The proposed algorithm can easily be embedded in a branch-and-bound procedure due to its convenient structure for the post-optimization in changes of the right-hand-side and multiple choice numbers. A numerical example is presented.

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A Heuristic Algorithm for $n/m/D/F/F_{max}$ (Flow Shop에서 준비시간이 작업순서에 종속적인 경우의 휴리스틱 알고리듬의 개발)

  • 최성운
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.8 no.11
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    • pp.79-83
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    • 1985
  • This paper is to develop four heuristic algorithms for $n/m/D/F/F_{max}$. A study present numerical example for (H1) algorithm. Among the sequence generated, the best sequence is J2, J1, J6, J7, J4, J3, J5 and makespan is 528. The optimal makespan of this numerical example can be found as 528 as also, and the worst value of heuristic solution is only 7.2 % away from it.

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IMPROVED BOUNDS OF POLYNOMIAL INEQUALITIES WITH RESTRICTED ZERO

  • Robinson Soraisam;Nirmal Kumar Singha;Barchand Chanam
    • Nonlinear Functional Analysis and Applications
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    • v.28 no.2
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    • pp.421-437
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    • 2023
  • Let p(z) be a polynomial of degree n having no zero in |z| < k, k ≥ 1. Then Malik [12] obtained the following inequality: $${_{max \atop {\mid}z{\mid}=1}{\mid}p{\prime}(z){\mid}{\leq}{\frac{n}{1+k}}{_{max \atop {\mid}z{\mid}=1}{\mid}p(z){\mid}.$$ In this paper, we shall first improve as well as generalize the above inequality. Further, we also improve the bounds of two known inequalities obtained by Govil et al. [8].

Bioequivalence of Cyclosporine A 100 mg Soft Capsules (Cipol-N® vs. Sandimmun Neoral®) in Healthy Korean Volunteers

  • Huh, Yong-Ho;Park, Eun-A;Chung, Youn-Bok;Pyo, Hee-Soo;Kwon, Oh-Seung
    • Journal of Pharmaceutical Investigation
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    • v.38 no.5
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    • pp.343-348
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    • 2008
  • The bioequivalence of two cyclosporine A (CyA) 100 mg soft capsules (Chong Kun Dang's $Cipol-N^{(R)}$ as the test drug; Korea Novartis' Sandimmun $Neoral^{(R)}$ as the reference drug) was assessed in healthy male Korean volunteers after oral administration of 200 mg CyA according to a randomized crossover design. The whole blood samples were analyzed for the determination of parent CyA in the blood by using a validated HPLC/diode array detector method. The mean $AUC_t$ values for reference and test products were $4095.3{\pm}1397.2$ and $3958.3{\pm}1138.2\;ng{\cdot}hr/mL$, respectively. The mean $C_{max}$ values were $1135.9{\pm}293.2\;ng/mL$ for the reference product, and $985.0{\pm}207.9\;ng/mL$ for the test product. $T_{max}$ was $1.6{\pm}0.4\;hr$ for the reference and $1.8{\pm}0.5\;hr$ for the test product. The differences of $AUC_t$, $C_{max}$ and $T_{max}$ were -3.35, -13.28 and +10.63%, respectively. The point estimates and 90% confidence intervals for $AUC_t$ and $C_{max}$ were 0.981 (0.9171 to 1.0514) and 0.876 (0.8229 to 0.9336), respectively. Based on the pharmacokinetic and statistical data, we conclude that these two products are bioequivalent and can be considered interchangeable in the medical practice.

The Refractive Index Change for Tinted Time of CR-39 Lens (CR-39 렌즈 착색시간에 따른 굴절률(n) 변화)

  • Kim, Yong Geun
    • Journal of Korean Ophthalmic Optics Society
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    • v.5 no.2
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    • pp.151-155
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    • 2000
  • We calculated a refractive index of the lens surface by measuring a spectral reflectance for a tinted time on manufacturing of the color lens. The longer a tinted time, the larger a reflectance and reflective index. The refractive index increased for a time up to the colorant's saturation state on the lens surface. The refractive index's change curve of blue color lens for a time depended on the Boltzmann growth curve. then we obtained the parameter's values of $n_{min}=1.482$, $n_{max}=1.497$, $t_c=11.53$ and $d_0=2.287$.

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ALMOST SURE MARCINKIEWICZ TYPE RESULT FOR THE ASYMPTOTICALLY NEGATIVELY DEPENDENT RANDOM FIELDS

  • Kim, Hyun-Chull
    • Honam Mathematical Journal
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    • v.31 no.4
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    • pp.505-513
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    • 2009
  • Let {$X_k;k{\in}N^d$} be centered and identically distributed random field which is asymptotically negative dependent in a certain case. In this note we prove that for $p{\alpha}$ > 1 and ${\alpha}$ > ${\frac{1}{2}}$ $E{\mid}X_1{\mid}^p(log^+{\mid}X_1{\mid}^{d-1})$ < ${\infty}$ if and only if ${\sum}_n{\mid}n{\mid}^{p{\alpha}-2}P$($max_{1{\leq}k{\leq}n{\mid}S_k{\mid}}$ > ${\epsilon}{\mid}n{\mid}$) < ${\infty}$ for all ${\epsilon}$ > 0, where log$^+$x = max{1,log x}.