• Archives of Pharmacal Research
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• 제26권7호
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• pp.564-568
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• 2003

Pharmacokinetic and pharmacodynamic properties of gliclazide were studied after an oral administration of gliclazide tablets in healthy volunteers. After an overnight fasting, gliclazide tablet was orally administered to 11 volunteers; Additional 10 volunteers were used as a control group (i.e., no gliclazide administration). Blood samples were collected, and the concentration determined for gliclazide and glucose up to 24 after the administration. Standard pharmacokinetic analysis was carried out for gliclazide. Pharmacodynamic activity of the drug was expressed by increase of glucose concentration ($\Delta$PG), by area under the increase of glucose concentration-time curve ($AUC_{$\Delta$PG}$) or by the difference in increase of glucose concentration ($D_{$\Delta$PG}$) at each time between groups with and without gliclazide administration. Pharmacokinetic analysis revealed that $C_{max}, T_{max}$, CL/F (apparent clearance), V/F (apparent volume of distribution) and half-life of gliclazide were $4.69\pm1.38 mg/L, 3.45\pm1.11 h, 1.26\pm0.35 L/h, 17.78\pm5.27 L, and 9.99\pm2.15 h$, respectively. When compared with the no drug administration group, gliclazide decreased significantly the $AUC_{$\Delta$PG}$ s at 1, 1.5, 2, 2.5, 3 and 4 h (p＜0.05). The $\Delta$PGs were positively correlated with $AUC_{gliclazide}$ at 1 and 1.5 h (p＜0.05), and the correlation coefficient was maximum at 1 h (r = 0.642) and gradually decreased at 4 h after the administration. The $AUC_{$\Delta$PG}$s were positively correlated with $AUC_{gliclazide}$ at 1, 2, 3 and 4 h (p＜0.05), and the maximum correlation coefficient was obtained at 2 h (r=0.642) after the administration. The $D_{$\Delta$PG}$ reached the maximum at 1 h, remained constant from 1 h to 3 h, and decreased afterwards. Therefore, these observations indicated that maximum hypoglycemic effect of gliclazide was reached at approximately at 1.5 h after the administration and the effect decreased, probably because of the homeostasis mechanism, in health volunteers.

• Journal of Pharmaceutical Investigation
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• 제35권5호
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• pp.355-360
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• 2005

The purpose of the present study was to evaluate the bioequivalence of two cetirizine HCl tablets, Zyrtec tablet (UCB Pharm. Co., Ltd. Korea, reference product) and Zyrix tablet (Kukje Pharm. Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (diazepam), plasma samples were extracted using 1 mL of dichloromethane. Compounds extracted were analyzed by reverse-phase HPLC with ultra-violet detector. This method for determination cetirizine is proved accurate and reproducible with a limit of quantitation of 10 ng/mL in male plasma. Twenty-four healthy male Korean volunteers received each medicine at the cetirizine HCl dose of 10 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of cetirizine were monitored for over a period of 24 hr after the administration. AUC (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$ (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 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 for the log transformed data were acceptable range of log 0.8 to log 1.25 $(e.g.,\;log\;0.93-log\;1.08\;for\;AUC_{0-t},\;log\;0.91-log\;1.08\;for\;AUC_{0-{\infty}}\;and\;log\;1.01-log\;1.11\;for\;C_{max})$. The major parameters, AUC and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zyrix tablet is bioequivalent to Zyrtec tablet.

• Biomolecules & Therapeutics
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• 제7권1호
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• pp.59-65
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• 1999

A bioequivalence study of the Dong Wha Cisapril tablets(Dong Wha Pharm. Ind. Co., Ltd.) to the Prepulsid tablets(Janssen Korea Ltd.), formulations of cisapride, was conducted. Twenty four healthy Korean male subjects received each formulation at the dose of 5 mg as cisapride in a 2$\times$2 crossover study. There was a 1-week washout period between the doses. Plasma concentrations of cisapride were monitored by an LC/MS method for over a period of 36 h after each administration. AUC(area under the plasma concentration- time curve from time zero to infinity) was calculated by the linear trapezoidal and extrapolation method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) 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 apparent differences between the formulations in these parameters were all far less than 20% (i.e., 6.8, -6.6 and 1.8% for AUC, $C_{max}$ and $T_{max}$, respectively). Minimum detectable differences(%) at $\alpha$=0.05 and 1-$\beta$=0.8 were all less than 20% in these parameters between the formulations (i.e., 16.5, 11.4 and 16.4% for AUC, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within 20% (i.e., -2.9~ 16.4, -13.2~0.1 and -7.8~ 11.4% for AUC, $C_{max}$ and $T_{max}$, respectively). These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 98-51). Therefore, these results indicate that the two formulations of cisapride are bioequivalent and, thus, may be prescribed interchangeably.hangeably.y.hangeably.

• Clinical Endoscopy
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• 제55권2호
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• pp.240-247
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• 2022

Background/Aims: Few studies have measured the accuracy of prognostic scores for upper gastrointestinal bleeding (UGIB) among cancer patients. Thereby, we compared the prognostic scores for predicting major outcomes in cancer patients with UGIB. Secondarily, we developed a new model to detect patients who might require hemostatic care. Methods: A prospective research was performed in a tertiary hospital by enrolling cancer patients admitted with UGIB. Clinical and endoscopic findings were obtained through a prospective database. Multiple logistic regression analysis was performed to gauge the power of each score. Results: From April 2015 to May 2016, 243 patients met the inclusion criteria. The AIMS65 (area under the curve [AUC] 0.85) best predicted intensive care unit admission, while the Glasgow-Blatchford score best predicted blood transfusion (AUC 0.82) and the low-risk group (AUC 0.92). All scores failed to predict hemostatic therapy and rebleeding. The new score was superior (AUC 0.74) in predicting hemostatic therapy. The AIMS65 (AUC 0.84) best predicted in-hospital mortality. Conclusions: The scoring systems for prognostication were validated in the group of cancer patients with UGIB. A new score was developed to predict hemostatic therapy. Following this result, future prospective research should be performed to validate the new score.

• 약학회지
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• 제45권2호
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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.

• 대한방사선기술학회지:방사선기술과학
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• 제45권2호
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• pp.111-116
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• 2022

In this study, the applicability of machine learning for the development of a simulator for general X-ray examination education is evaluated. To this end, k-nearest neighbor(kNN), support vector machine(SVM) and neural network(NN) classification models are analyzed to present the most suitable model by analyzing the results. Image data was obtained by taking 100 photos each corresponding to Posterior anterior(PA), Posterior anterior oblique(Obl), Lateral(Lat), Fan lateral(Fan lat). 70% of the acquired 400 image data were used as training sets for learning machine learning models and 30% were used as test sets for evaluation. and prediction model was constructed for right-handed PA, Obl, Lat, Fan lat image classification. Based on the data set, after constructing the classification model using the kNN, SVM, and NN models, each model was compared through an error matrix. As a result of the evaluation, the accuracy of kNN was 0.967 area under curve(AUC) was 0.993, and the accuracy of SVM was 0.992 AUC was 1.000. The accuracy of NN was 0.992 and AUC was 0.999, which was slightly lower in kNN, but all three models recorded high accuracy and AUC. In this study, right-handed PA, Obl, Lat, Fan lat images were classified and predicted using the machine learning classification models, kNN, SVM, and NN models. The prediction showed that SVM and NN were the same at 0.992, and AUC was similar at 1.000 and 0.999, indicating that both models showed high predictive power and were applicable to educational simulators.

• Biomolecules & Therapeutics
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• 제10권4호
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• pp.303-308
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• 2002

A bioequivalence study of Shin II Cefadroxil capsule (Shin II Pharm. Co. Ltd.) to Duricef capsule(Bo Ryung Pharm. Co. Ltd.), each containing 500 mg of cefadroxil, was conducted. Twenty three healthy Korean male subjects administered each formulation at the dose of 1 capsule (500 mg as cefadroxil) in 2 $\times$ 2 cross-over study. There was a I-week washout period between the doses. Plasma concentrations of cefadroxil were monitored for a period of 8 hr after each administration by an LC/UV method. Area under the plasma concentration-time curve up to 8 hr ($AUC_t$) was calculated by a linear trapezoidal method. $C_{max}$ was compiled from the plasma drug concentration-time data. ANOVA test was conducted for logarithmically transformed $AUC_t$ and $C_{max}$ The results showed that there are no significant differences in $AUC_t$ and $C_{max}$ between the two formulations: The differences between d1e formulations in these log transformed parameters were all for less than 20% (i.e., －0.57%, 3.84% for $AUC_t$ and $C_{max}$, respectively). The 90% confidence intervals for the log transformed data were within the acceptance range of log 0.8 to log 1.25 (i.e., log 0.94~log 1.04 and log 0.95~log 1.10 for $AUC_t$ and $C_{max}$, respectively). Based on d1e bioequivalence criteria of KFDA guidelines, the two formulations of cefadroxil were concluded to be bioequivalent.

• Journal of Ginseng Research
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• 제44권2호
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• pp.229-237
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• 2020

Background: We investigated the tolerability and pharmacokinetic properties of various ginsenosides, including Rb1, Rb2, Rc, Rd, and compound K, after single or multiple administrations of red ginseng extract in human beings. Methods: Red ginseng extract (dried ginseng > 60%) was administered once and repeatedly for 15 days to 15 healthy Korean people. After single and repeated administration of red ginsengextract, blood sample collection, measurement of blood pressure and body temperature, and routine laboratory test were conducted over 48-h test periods. Results: Repeated administration of high-dose red ginseng for 15 days was well tolerated and did not produce significant changes in body temperature or blood pressure. The plasma concentrations of Rb1, Rb2, and Rc were stable and showed similar area under the plasma concentration-time curve (AUC) values after 15 days of repeated administration. Their AUC values after repeated administration of red ginseng extract for 15 days accumulated 4.5- to 6.7-fold compared with single-dose AUC. However, the plasma concentrations of Rd and compound K showed large interindividual variations but correlated well between AUC of Rd and compound K. Compound K did not accumulate after 15 days of repeated administration of red ginseng extract. Conclusion: A good correlation between the AUC values of Rd and compound K might be the result of intestinal biotransformation of Rb1, Rb2, and Rc to Rd and subsequently to compound K, rather than the intestinal permeability of these ginsenosides. A strategy to increase biotransformation or reduce metabolic intersubject variability may increase the plasma concentrations of Rd and compound K.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• 제29권1호
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• pp.5-13
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• 2003

본 연구의 목적은 두경부 감염 환자에서 적혈구침강속도(ESR), 백혈구와 비교해 혈장 내 C-Reactive Protein(CRP)이 가지는 진단과 경과관찰에서의 기여도를 아는 데 있다. 본 연구를 위해 31명의 감염환자를 실험군으로, 32명의 악교정 수술 환자를 대조군으로 설정하여 다음과 같은 결과를 얻었다. 1. 실험군에서의 C-Reactive Protein(CRP)은 대조군의 CRP에 비해 더 높은 수치를 나타내며 감염이 지속되었던 증례를 제외하고는 지속적으로 감소하는 경향을 나타내었다(P<0.001). 2. ESR은 실험군과 대조군에서 모두 일정한 경향이 없었다. 3. 각 변수간의 상관관계는 CRP와 백혈구가 상관계수 0.664로 가장 높은 양의 상관관계를 나타내었다(r=0.664, P<0.01). 4. 설정된 ROC curve에서 분류기준값(cut-off value)의 변화에 따라 CRP 곡선의 증가가 빠르게 나타나고 측정된 곡선의 아래 면적(AUC: Area Under the Curve)이 0.744로 높은 값을 나타내어 예측의 정확도가 높다고 판단된다. 5. 실험군에서 회복일(recovery day)에 각 변수의 민감도는 CRP가 83%, ESR이 17%, 백혈구가 71%로 나타났다. 이상의 연구로 미루어 볼 때, 두경부 영역에서 CRP는 감염을 진단하고 경과관찰을 하는데 있어 ESR이나 Leukocyte에 비해 더 민감하게 환자를 감시(monitoring)할 수 있는 유용한 검사라고 사료된다.

• 한국측량학회지
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• 제34권6호
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• pp.597-607
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• 2016

The goal of this study was to analyze landslide susceptibility using two different models and compare the results. For this purpose, a landslide inventory map was produced from a field survey, and the inventory was divided into two groups for training and validation, respectively. Sixteen landslide conditioning factors were considered. The relationships between landslide occurrence and landslide conditioning factors were analyzed using the FR (Frequency Ratio) and EBF (Evidential Belief Function) models. The LSI (Landslide Susceptibility Index) maps that were produced were validated using the ROC (Relative Operating Characteristics) curve and the SCAI (Seed Cell Area Index). The AUC (Area under the ROC Curve) values of the FR and EBF LSI maps were 80.6% and 79.5%, with prediction accuracies of 72.7% and 71.8%, respectively. Additionally, in the low and very low susceptibility zones, the FR LSI map had higher SCAI values compared to the EBF LSI map, as high as 0.47%p. These results indicate that both models were reasonably accurate, however that the FR LSI map had a slightly higher accuracy for landslide susceptibility mapping in the study area.