• Journal of Pharmaceutical Investigation
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• v.37 no.4
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• pp.255-261
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• 2007

A bioequivalence study of $Nimegen^{TM}$ soft capsule (Medica Korea Pharma. Co., Ltd.) to $RoAccutane^{(R)}$ soft capsule (Roche Korea Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty healthy male Korean volunteers received each medicine at the isotretinoin dose of 60 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of isotretinoin were monitored by a high performance liquid chromatography (HPLC) for over a period of 48 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48 hr) was calculated by the linear trapezoidal rule method. $C_{MAX}$ (maximum plasma drug concentration) and $T_{MAX}$ (time to reach $C_{MAX}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t\;and\;C_{MAX}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{MAX}$ ratio for $Nimegen^{TM}/RoAccutane^{(R)}$ were $log0.860{\sim}log0.98\;and\;log0.85{\sim}log1.00$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Thus, our study demonstrated the bioequivalence of $Nimegen^{TM}\;and\;RoAccutane^{(R)}$ with respect to the rate and extent of absorption.

• The Journal of Korean Institute of Communications and Information Sciences
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• v.37A no.10
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• pp.841-849
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• 2012

This paper proposes an low-complexity soft-output multiple-input multiple-output (soft-MIMO) detection algorithm for achieving soft-output maximum-likelihood (soft-ML) performance under max-log approximation. The proposed algorithm is based on a parallel tree-search (PTS) applying a channel ordering by a sorted-QR decomposition (SQRD) with altered sort order. The empty-set problem that can occur in calculation of log-likelihood ratio (LLR) for each bit is solved by inserting additional nodes at each search level. Since only the closest node is inserted among nodes with opposite bit value to a selected node, the proposed node insertion scheme is very efficient in the perspective of computational complexity. The computational complexity of the proposed algorithm is approximately 37-74% of that of existing algorithms, and from simulation results for a $4{\times}4$ system, the proposed algorithm shows a performance degradation of less than 0.1dB.

• The Journal of Korean Institute of Communications and Information Sciences
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• v.31 no.6A
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• pp.611-616
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• 2006

In this paper, we propose a practical implementation method of a soft bit decision expression for an R-QAM (Gray coded Rectangular Quadrature Amplitude Modulation) signal based on the Max-Log-MAP algorithm. The parameters of the soft decision expression for the practical implementation can be obtained with simple arithmetic functions associated with some deterministic parameters such as a received value, distances between symbols, and the order of modulation on a signal space. Also, we analyze the performance of an iterative decoding scheme for the QAM signal with I/Q phase unbalance. The unbalance results from the non-ideal characteristic of components such as a phase shifter between in-phase and quadrature paths for quadrature modulator/demondulator.

• Journal of the Korea Institute of Military Science and Technology
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• v.15 no.4
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• pp.359-365
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• 2012

In the soft recoil system, the recoiling parts are initially accelerated to the forward direction. These parts are returned to original position by the firing with intial acceleration speed. The latch of the soft recoil system keeps the high impact load when the recoil parts were recuperated to the forward direction. In this study, the latch of soft recoil system using the ADAMS program was analyzed. The optimal operation parameters were found that max. angle and expansion length of latch was $50^{\circ}$, 180 mm respectively. Dynamic structural analyses of model cases were performed using finite element model. The max. stress and deflection of latch was 230 MPa and 0.45 mm respectively.

• Journal of Pharmaceutical Investigation
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• v.34 no.1
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• pp.49-55
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• 2004

To develop a aceclofenac soft capsule, four preparations with various solubilizers were prepared and their dissolution test was carried out. Among four preparations tested, a preparation with ethanolamine was selected as a formula of aceclofenac soft capsule (Clanza $S^{TM}$), since it showed the fastεst dissolution rate. Bioequivalence of aceclofenac tablet, $Airtal^{TM}$ (Dae-Woong Pharmaceutical Co., Ltd.) and aceclofenac soft capsule, Clanza $S^{TM}$ (Korea United Pharmaceutical Co., Ltd.) was evaluated according to the guideline of KA Fourteen normal male volunteers (age 20 - 25 years old) were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After oral administration of one tablet or capsule containing 100 mg of aceclofenac, blood was taken at predetermined time intervals and the concentration of aceclofenac in plasma was determined with an HPLC method under UV detector The pharmacokinetic parameters ($C_{max}$ and $AUC_t$) were calculated and ANOVA was utilized for the statistical analysis of parameters using logarithmetically transformed $AUC_t$, $C_{max}$ and $T_{max}$. The results showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between Aral tablet and Clanza soft capsule were 2.89%, 0.18% and 43.0%, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(15) (e.g. log(0.81) -log(1.23) ad log(0.89) -log(1.4)) fo $AUC_t$ and $C_{max}$, respectively. Thus, the criteria of the KFDA guidelines for the equivalence was satisfied, indicating that Clanza $S^{TM}$ soft capsule is bioequivalent to$Airtal^{TM}$ tablet.

• Biomolecules & Therapeutics
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• v.8 no.3
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• pp.269-275
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• 2000

Silibinin(silybin) is the active component of silymarin from Silybum marianum and has hepato-protective effect. It is water-insoluble and has low bioavailability. To improve its bioavailability, self-micro-emulsifying drug delivery system (SMEDDS) has been developed by Hanmi Pharmaceutical Company (Silyma $n^{R}$ 140 soft capsule). In this study, the pharmacokinetic profiles of Silyma $n^{R}$ were examined and compared it with a reference preparation, L Caps140 of B Pharmaceutical Company. This study was approved by Yonsei University Severance Hospital IRB(approval No. CR0004) and followed the bioequivalence test guideline of Korean FDA. Eighteen healthy adult volunteers were allocated based on 2$\times$2 Latin square cross-over design. They were given 2 capsules (each contains silymarin 140 mg (60 mg as silibinin)) of either drug at each period and crossed over after a week of drug-free washout period. Blood concentration of silibinin was measured by HPLC. The $C_{max}$ and AUC of the Silyma $n^{R}$ were 1542.0 $\pm$ 402.7 ng/ml and 3323.3 $\pm$ 824.7 ng.h/ml, respectively, and were significantly higher than those of reference preparation. The Tmax was 0.8 $\pm$ 0.3 h and significantly shorter than reference preparation. The $K_{e}$ and $T_{1}$2/ of both drugs were comparable. Percent differences in means against reference preparation were +88.3% for AUC, +222.6% for $C_{max}$, and -61.1% for $T_{max}$./.>././.>./.

• 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.

• Earthquakes and Structures
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• v.2 no.3
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• pp.257-277
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• 2011

An evaluation is presented of the response of a 3-storey R/C structure during the destructive Lefkada earthquake of 14/08/2003. Key aspects of the event include: (1) the unusually strong levels of ground motion (PGA = 0.48 g, $SA_{max}$ = 2.2 g) recorded approximately 10 km from fault, in downtown Lefkada; (2) the surprisingly low structural damage in the area; (3) the very soft soil conditions ($V_{s,max}$ = 150 m/s). Structural, geotechnical and seismological aspects of the earthquake are discussed. The study focuses on a 3-storey building, an elongated structure of rectangular plan supported on strip footings, that suffered severe column damage in the longitudinal direction, yet minor damage in the transverse one. Detailed spectral and time-history analyses highlight the interplay of soil, foundation and superstructure in modifying seismic demand in the two orthogonal directions of the building. It is shown that soil-structure interaction may affect inelastic seismic response and alter the dynamic behavior even for relatively flexible systems such as the structure at hand.

• YAKHAK HOEJI
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• v.48 no.6
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• pp.379-383
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• 2004

Biphenyl dimethyl dicarboxylate (DDB) has been used for the treatment of chronic viral hepatitis B and drug-induced hepatitis through the inhibition of lipid peroxidation and c ovalent binding of drug metabolites to lipids of microsomes. The bioequivalence of two DDB products was evaluated according to the guidelines of KFDA. The test product was Hepaphil soft capsule(R) made by KMS Pharm. Co. Containing 3 mg DDB and the reference product was Nissel tablet(R) made by Taerim Pharm. Co. Containing 25 mg DDB. Twenty healthy male subjects, 25.4(22~30) years old and 66.7(54~77)kg, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets or two capsules were orally administered, blood was taken at predetermined time intervals and the concentration of DDB in plasma was determined using a validated HPLC method with UV detector. Two pharmacokinetic parameters, $AUC_t$ and $C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t$ and $C_{max}$ were log 0.91~log1.00 and log 1.05~log 1.15, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hepaphil soft capsule is bioequivalent to Nissel tablet.

• Proceedings of the Korea Society of Design Studies Conference
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• 2003.11a
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• pp.94-95
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• 2003