• Title/Summary/Keyword: $R_max$

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Bioequivalence of GLUNATE® Tablet to PASTIC® Tablet (nateglinide 90 mg) (파스틱 정®(나테글리니드 90 mg)에 대한 글루나테 정®의 생물학적 동등성)

  • Tak, Sung-Kwon;Lee, Jin-Sung;Choi, Sang-Joon;Seo, Ji-Hyung;Lee, Myung-Jae;Kang, Jong-Min;Ryu, Ju-Hee;Hong, Seung-Jae;Yim, Sung-Vin;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.39 no.2
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    • pp.141-147
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    • 2009
  • The purpose of this study was to evaluate the bioequivalence of two nateglinide tablets, $PASTIC^{(R)}$ tablet (ILDONG Pharm. Co., Ltd., Seoul, Korea, reference drug) and $GLUNATE^{(R)}$ tablet (ILHWA. Co., Ltd., Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty-five healthy male volunteers, $23.1{\pm}2.3$ years in age and $69.2{\pm}8.8\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a tablet containing 90 mg of nateglinide was orally administrated, blood was taken at predetermined time intervals over a period of 8 hr and concentrations of nateglinide in plasma were monitored using LC-MS/MS. Pharmacokinetic parameters such as AUCt (the area under the plasma concentration-time curve from time 0 to 8 hr), $C_{max}$ (maximum plasma drug concentration) and $TC_{max}$ (time to reach $CC_{max}$) were calculated and analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$ and untransformed $T_{max}$. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $GLUNATE^{(R)}/PASTIC^{(R)}$ were ${\log}1.0782{\sim}{\log}1.1626$ and ${\log}0.9621{\sim}{\log}1.1679$, respectively. Since these values were within the acceptable bioequivalence intervals of ${\log}0.80{\sim}{\log}1.25$, recommended by KFDA, it was concluded that $GLUNATER^{(R)}$ tablet was bioequivalent to $PASTIC^{(R)}$ tablet, in terms of both rate and extent of absorption.

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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Lr INEQUALITIES OF GENERALIZED TURÁN-TYPE INEQUALITIES OF POLYNOMIALS

  • Singh, Thangjam Birkramjit;Krishnadas, Kshetrimayum;Chanam, Barchand
    • Nonlinear Functional Analysis and Applications
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    • v.26 no.4
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    • pp.855-868
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    • 2021
  • If p(z) is a polynomial of degree n having all its zeros in |z| ≤ k, k ≤ 1, then for 𝜌R ≥ k2 and 𝜌 ≤ R, Aziz and Zargar [4] proved that $${\max_{{\mid}z{\mid}=1}}{\mid}p^{\prime}(z){\mid}{\geq}n{\frac{(R+k)^{n-1}}{({\rho}+k)^n}}\{{\max_{{\mid}z{\mid}=1}}{\mid}p(z){\mid}+{\min_{{\mid}z{\mid}=k}}{\mid}p(z){\mid}\}$$. We prove a generalized Lr extension of the above result for a more general class of polynomials $p(z)=a_nz^n+\sum\limits_{{\nu}={\mu}}^{n}a_n-_{\nu}z^{n-\nu}$, $1{\leq}{\mu}{\leq}n$. We also obtain another Lr analogue of a result for the above general class of polynomials proved by Chanam and Dewan [6].

ERROR BOUNDS FOR GAUSS-RADAU AND GAUSS-LOBATTO RULES OF ANALYTIC FUNCTIONS

  • Ko, Kwan-Pyo
    • Communications of the Korean Mathematical Society
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    • v.12 no.3
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    • pp.797-812
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    • 1997
  • For analytic functions we give an expression for the kernel $K_n$ of the remainder terms for the Gauss-Radau and the Gauss-Lobatto rules with end points of multiplicity r and prove the convergence of the kernel we obtained. The error bound are obtained for the type $$\mid$R_n(f)$\mid$ \leq \frac{1}{\pi}l(\Gamma) max_{z \in \Gamma} $\mid$K_n(z)$\mid$ max_{z \in \Gamma} $\mid$f(z)$\mid$$, where $l(\Gamma)$ denotes the length of contour $\Gamma$.

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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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Pharmacokinetics and Oral Bioavailability of Paclitaxel Microemulsion in Rats

  • Hur, Hye-Jung;Park, Joon-Hee;Kim, Seo-Young;Yang, Hyun-Kyoung;Kim, Ji-Hyeon;Ryu, Jae-Kook;Woo, Jong-Soo;Lee, Byung-Koo;Lee, Hwa-Jeong
    • Journal of Pharmaceutical Investigation
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    • v.38 no.5
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    • pp.331-334
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    • 2008
  • The objectives of this study were to formulate oral paclitaxel microemulsion and to compare the bioavailability of paclitaxel in the microemulsion formulation from the commercially available $Taxol^{(R)}$ formulation. Paclitaxel microemulsion was formulated with much less amount of Cremophor $EL^{TM}$ as compared with $Taxol^{(R)}$ to reduce severe adverse reactions produced by Cremophor $EL^{TM}$. The area under the plasma concentration-time curve from 0 hr to 24 hr ($AUC_{0-24}$), maximum plasma concentration ($C_{max}$), and relative bioavailability of palcitaxel microemulsion were increased as compared with $Taxol^{(R)}$ after oral administration. The time required to reach $C_{max}\;(T_{max})$ of palcitaxel microemulsion was significantly shorter than $Taxol^{(R)}$ following oral administration. These results suggest the faster intestinal absorption and the enhanced oral bioavailability of paclitaxel in the microemulsion formulation.

The Correlation of Foot Pressure with Spinal Alignment in Static Standing (정적 기립 자세에서 족저압 분포와 척추 정렬과의 상관관계 연구)

  • Lim, Jae-Heon;Ko, Hyo-Eun
    • PNF and Movement
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    • v.12 no.1
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    • pp.13-17
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    • 2014
  • Purpose: To determine the normative data for the correlation of spinal, pelvic parameters with foot pressure in the young subjects. Methods: The subjects of this study were 39 patients in healthy adults. The Formetric-III was used to measure of spinal alignment. The pedoscan was used to measure of foot pressure. The correlation of trunk imbalance, trunk inclination, lateral deviation with foot pressure. The foot pressure measurement was consisted of maximal/mean pressure, weight contribution. Result: There was a negative correlation of trunk inclination with Max_R. There was a negative correlation of trunk inclination with Max_R. There was a positive correlation of trunk imbalance with Max_L. There was a positive correlation of lumbar lordosis with Mean_R_front, Lt. posterior weight distribution. There was a negative correlation of lumbar lordosis with Lt., Rt. in distribution There was a negative correlation of pelvic tilt with Mean_R_front, Lt. posterior weight distribution. There was a positive correlation of pelvic tilting with Rt. weight distribution, Lt. posterior weight distribution. There was a negative correlation of pelvic torsion with Lt. weight distribution, Rt. posterior weight distribution. There was a negative correlation of pelvic rotation with Lt. weight distribution, Lt. posterior weight distribution. Conclusion: The data obtained from the study may be used for future studies related to correlation of the spinal, pelvic deviation with foot pressure.

Bioequivalence of Cefaclor 375 mg SR Tablet (세파클러 375 mg서방정의 생물학적 동등성)

  • Lee, Shin Hwa;Yun, Min Hyuk;Choi, Kyung Eob;Kwon, Kwang Il
    • Korean Journal of Clinical Pharmacy
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    • v.13 no.1
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    • pp.13-17
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    • 2003
  • This study was carried out to compare the bioavailability of $Ceclex^{(R)}$ SR TAB (test drug, cefaclor 375 mg/Tablet) with that of Ceclor $MR^{(R)}$ SR IAB (reference drug) and to estimate the pharmacokinetic parameters of cefaclor in healthy Korean volunteers. The bioavailability was examined on 24 healthy volunteers who received a single dose (375 mg) of each drug in the fasting state in a randomized balanced 2-way crossover design. After dosing, blood samples were collected for a period of 7 hours. Plasma concentrations of cefaclor were determined using HPLC with UV detection. The pharmacokinetic parameters $(AUC_{0-7h},\;C_{max},\;T_{max},\;AUC_{inf},\;K_e,\;t_{1/2},\;V_d/F,\;and\;CL/F)$ were calculated with non-compartmental pharmacokinetic analysis. The ANOVA test was utilized for the statistical analysis of the $T_{max}$, log-transformed $AUC_{0-7h$}$, log-transformed $C_{max},\;t_{1/2},\;V_d/F$, and $CL/F$. The ratios of geometric means of $AUC_{0-7h}\;and\;C_{max}$ between test drug End reference drug were $95.67\%\;(8.55\;vs\;8.18{\mu}g{\cdot}hr/ml)\;and\;103.86\%\;(2.85\;vs\;2.96{\mu}g/ml)$, respectively. The $T_{max}$ of test drug and reference drug was $2.56\pm0.15\;and\;2.23\pm0.13\;hrs,\;respectively.\;The\;90\%$ confidence intervals of mean difference of logarithmic transformed $AUC_{0-7h}\;and\;C_{max}$ were log0.90-log1.04 and log0.91-log1.13, respectively. It shows that the bioavailability of test drug is equivalent with that of reference drug.

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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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