• Journal of Pharmaceutical Investigation
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• v.31 no.2
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• pp.125-130
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• 2001

Bucillamine is a novel cysteine derivative with two free intramolecular sulfhydryl groups, and has a preventive and therapeutic effect on adjuvant arthritis, suggesting its antirheumatic action. With respect to the effect on the immune system, bucillamine-exerted such immunoregulating actions are to nomalize an excessive reduction or acceleration in immune reaction. It is useful not only in patients with early stage of rheumatoid arthritis (RA) but also in those with active RA retained for more than 10 years. The purpose of the present study was to evaluate the bioequivalence of two bucillamine tablets, $Rimatil^{TM}$ (Chong Kun Dang Pharmaceutical Co., Ltd.) and $Bucilin^{TM}$ (Kuhn Il Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $23.67{\pm}2.09$ years in age and $65.03{\pm}6.73\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three tablets containing 100 mg of bucillamine per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of bucillamine in serum were determined using GC/MS with mass selective 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 tablets were -0.29%, -3.20% and 8.22%, respectively, when calculated against the $Rimatil^{TM}$ tablet. The powers $(1-{\beta})$ for $AUC_t\;and\;C_{max}$ were 84.31 % and 91.16%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.10$ and $1-{\beta}=0.8$ were less than 20% (e.g., 18.58% and 16.51% for $AUC_t\;and\;C_{max}$, respectively). The 90% confidence intervals were within ${\pm}20%$ (e.g.,$-12.77{\sim}12.20$ for $AUC_t$ and $-14.30{\sim}7.90$ for $C_{max}$). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Bucilin^{TM}$ tablet is bioequivalent to $Rimatil^{TM}$ tablet.

• Journal of the Earthquake Engineering Society of Korea
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• v.14 no.1
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• pp.25-34
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• 2010

A method is presented for evaluating the seismic failure probability of bridge structures which show a nonlinear hysteretic dynamic behavior. Bridge structures are modeled as a bilinear dynamic system with a single degree of freedom. We regarded that the failure of bridges will occur when the displacement response of a deck level firstly crosses the predefined limit state during a duration of strong motion. For the estimation of the first-crossing probability of a nonlinear structural system excited by earthquake motion, we computed the average frequency of crossings of the limit state. We presented the non-Gaussian closure method for the approximation of the joint probability density function of response and its derivative, which is required for the estimation of the average frequency of crossings. The failure probabilities are estimated according to the various artificial earthquake acceleration sets representing specific seismic characteristics. For the verification of the accuracy and efficiency of presented method, we compared the estimated failure probabilities with the results evaluated from previous methods and the exact values estimated with the crude Monte-Carlo simulation method.