• Biomolecules & Therapeutics
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• v.6 no.3
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• pp.289-295
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• 1998

The bioequivalence of two nilvadipine products was evaluated in 16 normal male volunteers (age 22-32 yr, body weight 57-80 kg) following sidle oral dose. Test product was Overca $l_{R}$ tablet (Choong-Wae Pharm. Corp., Korea) and reference product was Nivadi $l_{R}$ tablet (Hyundai Pharm. Corp., Korea). Both products contain 4 mg of nilvadipine. One tablet of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study (2$\times$2 Latin square method). The determination of nilvadipine was accomplished using a validated capillary column GC with electron-capture detection. As a result of the assay validation, the quantiflcation of nilvadipine in human plasma by this technique was possible down to 0.5 ng/ml using 1 ml of plasma. Absolute overall recovery from five replicate analyses of nilvadipine-spiked sample were 88.4$\pm$ 10.24% (mean$\pm$ 5.D.) for human plasma of 10 ng/ml. The coefficients of variation (C.V.) were less than 20% and the actual concentration of nilvadipine measured by GC ranged from 80 to 99% in all plasma. 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 from time zero to 8 hr (AUCo-$_{8 hr}$) (22.8$\pm$5.90 vs 22.2$\pm$6.10 ng . hr/ml), maximum plasma concentration ( $C_{max}$) (10.0$\pm$2.85 vs 9.3$\pm$3.28 ng/ml) and time to reach maximum plasma concentration ( $T_{max}$) (1.2$\pm$0.31 vs 1.3 $\pm$0.47 hr). The differences of mean AU $Co_{8hr}$ $C_{max}$, and $T_{max}$ between the two products (2.25, 7.65, and 10.30%, respectively) were less than 20%. The power (1-$\beta$) and treaeent difference (7) for AU $Co_{8hr}$, and $C_{max}$ were more than 0.8 and less than 0.2, respectively. Although the power for Tmax was under 0.8, Tm\ulcorner of the two products was not significantly different from each other (p>0. 05). These results suggest that the bioavailability of Overeat tablet is not significantly different from that of Nivadil tablet. Therefore, two products are bioequivalent based on the current results.sults.lts.lts.lts.

• Korean Journal of Clinical Pharmacy
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• v.10 no.1
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• pp.13-18
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• 2000

The bioequivalence of two clarithromycin tablets, the $Klaricid^{TM}$ (Ciba-Geigy Korea Ltd.) and the $Pylocin^{TM}$ (Kyungdong Pharmaceutical Co., Ltd.), was evaluated according to the Korean Guidelines for Bioequivalence Test (KGBT 1998). Sixteen healthy male volunteers ($20\sim26$ years old) were randomly divided into two groups and a randomized $2\times2$ cross-over study was employed. After one tablet containing 250 mg of clarithromycin was orally administered, blood sample was taken at predetermined time intervals, and the concentrations of clarithromycin in serum were determined using high-performance liquid chromatographic method with electrochemical detector. The pharmaco-kinetic parameters (area under the concentration-time curve: $AUC_t$, maximum concentration; $C_{max}$ and time to maximum concentration; $T_{max}$) were calculated and analysis of variance (ANOVA) was utilized for the statistical analysis of parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on $Klaricid^{TM}$ tablet were $-0.22\%,\;-0.48\%\;and\;-1.63\%$, respectively. The powers $(1-\beta)\;for\;AUC_t,\;C_{max}\;and\;T_{max}\;were\;99.07\%,\;88.15\%\;and\;99.99\%$, respectively. Detectable differences $(\Delta)\;and\;90\%$ confidence intervals ($\alpha$=0.10) were all less than $\pm20\%$ All the parameters above met the criteria of KGBT 1998, indicating that $Pylocin^{TM}$ tablet is bioequivalent to $Klaricid^{TM}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.30 no.2
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• pp.133-138
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• 2000

Terbinafine is an orally active antifungal agent as it inhibits the fungal enzyme squalene epoxidase, which is important in the early biosynthetic pathway of ergosterol. This leads to abnormal development of the fungal cell membrane. Bioequivalence of two terbinafine tablets, $Lamisil^{TM}$ (Novartis Korea Ltd.) and $Terbina^{TM}$ (Korean Drug Co., Ltd.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers, $23.56{\pm}1.75$ years old and $65.60{\pm}8.54\;kg$ of body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 125 mg of terbinafine was orally administered, blood was taken at predetermined time intervals and the serum concentrations of terbinafine were determined using an HPLC method with UV detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\;T_{max})$ were calculated and ANOVA test was utilized for the statistical analysis of parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on $Lamisil^{TM}$, tablet were -2.53%, -2.98% and 8.13%, respectively. The powers $(1-{\beta})$ for $AUC_t,\;C_{max}\;and\;T_{max}$ were 85.21%, 98.21% and 93.11%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.1\;and\;1-{\beta}=0.8$ were all less than 20%. The 90% confidence intervals were all within ${\pm}20%$. All the parameters above met the criteria of KFDA for bioequivalence, indicating that $Terbina^{TM}$ tablet is bioequivalent to $Lamisil^{TM}$ tablet.

• Journal of Korean Neurosurgical Society
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• v.65 no.2
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• pp.315-324
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• 2022

Objective : The aim of this study was to verify the equivalence and effectiveness of the tablet-administered Korean Repeatable Battery for the Assessment of Neuropsychological Status (K-RBANS) for the prevention and early detection of dementia. Methods : Data from 88 psychiatry and neurology patient samples were examined to evaluate the equivalence between tablet and paper administrations of the K-RBANS using a non-randomly equivalent group design. We calculated the prediction scores of the tablet-administered K-RBANS based on demographics and covariate-test scores for focal tests using norm samples and tested format effects. In addition, we compared the receiver operating characteristic curves to confirm the effectiveness of the K-RBANS for preventing and detecting dementia. Results : In the analysis of raw scores, line orientation showed a significant difference (t=-2.94, p<0.001), and subtests showed small to large effect sizes (0.04-0.86) between paper- and tablet-administered K-RBANS. To investigate the format effect, we compared the predicted scaled scores of the tablet sample to the scaled scores of the norm sample. Consequently, a small effect size (d≤0.20) was observed in most of the subtests, except word list and story recall, which showed a medium effect size (d=0.21), while picture naming and subtests of delayed memory showed significant differences in the one-sample t-test. In addition, the area under the curve of the total scale index (TSI) (0.827; 95% confidence interval, 0.738-0.916) was higher than that of the five indices, ranging from 0.688 to 0.820. The sensitivity and specificity of TSI were 80% and 76%, respectively. Conclusion : The overall results of this study suggest that the tablet-administered K-RBANS showed significant equivalence to the norm sample, although some subtests showed format effects, and it may be used as a valid tool for the brief screening of patients with neuropsychological disorders in Korea.

• Journal of Pharmaceutical Investigation
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• v.39 no.3
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• pp.221-226
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• 2009

The purpose of the present study was to evaluate the bioequivalence of two alprazolam tablets, Xanax 0.25 mg (Pharmacia Korea Pharm. Co., Ltd.) and Zyren 0.25 mg (Kwang Dong Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The alprazolam release from two alprazolam tablets in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solutions and water). The dissolution profiles of two alprazolam tablets were very similar at all dissolution media. Twenty four healthy male volunteers were divided into two groups with a randomized 2${\times}$2 cross-over study. After four tablets (1 mg alprazolam) were orally administrated, blood was taken and the concentrations of alprazolam in serum were determined using LC/MS/MS. The pharmacokinetic parameters such as $AUC_t$, $C_max$ and $T_max$were determined. Our results showed that the differences in $AUC_t$, $C_max$ and $T_max$ between two alprazolam tablets based on the Xanax were -11.65%, -4.44% and -39.31%, respectively. There were no sequence effects between two tablets in these parameter. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25)(e.g., log(0.8386)${\sim}$log(0.9453) and log(0.8596)${\sim}$log(1.1040) for $AUC_t$, $C_max$, respectively). Thus, Zyren 0.25 mg tablet was bioequivalent to Xanax 0.25 mg tablet.

• Proceedings of the Korean Society of Near Infrared Spectroscopy Conference
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• 2001.06a
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• pp.4111-4111
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• 2001

When a drug is prepared in a tablet, the active component represents only a small portion of the dosage form. The other components of the formulation include materials to assist in the dissolution, antioxidants, coloring agents and bulk fillers. The tablets are tested using approved testing methods usually involving separation and subsequent quantification of the active component. Tablets may also be tested by near-Infrared Reflectance spectrometry (NIRS). In the present study, based on NIRS and multivariate calibration methods, a novel and precise method is developed for direct determination of ascorbic acid in vitamin C tablet. Two different tablet formulations were powdered in three different sizes, 63-125 ${\mu}{\textrm}{m}$, and examined. Spectral region of 4750-4950 $cm^{-1}$ / was used and optimized for quantitative operations. Partial least squares (PLS) and multiple linear regression (MLR) methods were performed for this spectral region. The results of optimized PLS and MLR methods showed that reproducibility increase with decreasing grain size and standard error of calibration (SEP) of less than 1% w/w of ascorbic acid and a correlation coefficient of 0.998 can be achieved. The PLS method showed better results than MLR. Seven overdose and underdose samples (prepared in the laboratory to match marketed products) were tested by proposed and iodometric standard methods. A correlation between NIRS predicted ascorbic acid values and iodomet.ic values was calculated ($R^2$=0.9950). Finally, the direct analysis of individual intact tablets in their unit-dose packages (Blistering in aluminum and PVC foils) obtained from market were also carried out and a correlation coefficient of 0.9989 and SEP of 0.931% w/w of ascorbic acid were achieved.

• Journal of Pharmaceutical Investigation
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• v.33 no.3
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• pp.201-208
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• 2003

Pharmacokinetics and oral bioavailability of levosulpiride was determined in Korean healthy male volunteers. Thirty subjects received a single oral dose (25 mg) of a tablet in a randomized $2{\times}2$ cross-over design. The plasma concentrations of levosulpiride were measured by HPLC and compared with those reported in the literature. Pharmacokinetic parameters for $Isomeric^{\circledR}$ tablet (levosulpiride 25 mg) were revealed as follows: $AUC_{inf}\;737.1{\pm}176.9\;ng{\cdot}hr/ml,\;C_{max}\;56.4{\pm}20.1\;ng/ml,\;T_{max}\;4.2{\pm}1.6\;hr,\;K_a\;1.00{\pm}1.09\;hr^{-1},\;K_{el}\;0.08{\pm}0.02\;hr^{-1},\;and\;t_{1/2}\;8.8{\pm}1.9\;hr$. The rate constant of the absorption phase was obtained based on the first-order kinetics. In the aspect of bioavailability, $Isomeric^{\circledR}$ tablet was bioequivalent to the other product $(Levopride^{\circledR}\;tablet)$ available in the Korea market. Intersubject variations and race differences were show in comparison with the published data in the literature, even though there was a linear relationship between dose ad extent of bioavailability.

• The Journal of the Korea Contents Association
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• v.13 no.11
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• pp.541-550
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• 2013

Generally in case of tablet PC's, the Windows 8 is used to support various functions or development convenience, however it cannot support real-time processing. In addition, existing commercial solutions and RTiK has a problem to support real-time processing due to impossibility of getting APIC timer count value which is used to generate timer interrupt separated from that of Windows. Thus, in this paper, we set the initial APIC count value using MSR_FSB_FREQ to support real-time processing on the Windows 8-based tablet PC's. Additionally, we deal with designing and implementing RTiK+ providing real-time processing to guarantee interrupt periods by controlling C-State which is used for low power techniques. To evaluate the performance of the proposed RTiK+, we measured the periods of generated real-time threads using RDTSC instructions which return the number of CPU clock ticks, and verified that RTiK+ operates correctly within the error ranges of 1ms.

• Journal of Korean Clinical Nursing Research
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• v.24 no.2
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• pp.147-158
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• 2018

Purpose: This study was conducted to identify the effects of educational video program delivered using Tablet PC on physical discomfort, uncertainty, state anxiety, and nursing education satisfaction among early gastric cancer patients undergoing endoscopic submucosal dissection. Methods: The study design was nonequivalent control group pretest-posttest design. The subjects were 60 patients who were hospitalized to undergo endoscopic submucosal dissection. The experimental group watched educational video using Tablet PC (n=30) and the control group received only the usual education (n=30). The collected data were analyzed using independent t-test to examine study hypothesis. Results: The level of physical discomfort (t=3.05, p=.003) and nursing education satisfaction (t=-2.20, p=.032) in the experimental group were significantly different from that of the control group. However, the level of uncertainty (t=-0.82, p=.418) and state anxiety (t=-1.69, p=.097) in the experimental group were not different from that of the control group. Conclusion: The study findings confirm that the educational video program delivered using Tablet PC as an effective intervention alleviating physical discomfort and improving satisfaction regarding nursing education among early gastric cancer patients undergoing endoscopic submucosal dissection. Based on the findings, we believe that the educational video program can be helpful in decreaseing physical discomfort, and it also can be utilized to improve nursing education satisfaction.

• Journal of Practical Engineering Education
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• v.15 no.2
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• pp.389-400
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• 2023

Technological advancements in the field of information and communication have led to the advent and usage of various types of smart devices, which have significantly altered people's usage behaviors and environments. This change has also been applied to the learning environment, where various smart devices are appearing and the learning behavior of learners is changing accordingly. In this study, we investigate learners' perceptions of digital note-taking behaviors focusing on the recently emerged learning media, tablet PCs and digital pens. Drawing upon the expectancy-confirmation model, we conduct a study on the factors affecting the (dis)confirmation and (dis)satisfaction of undergraduate students with tablet PCs and digital pens by comparing their expectations with their actual use experiences. An open-ended survey was conducted among students at C University in Korea, and the responses were analyzed through qualitative content analysis to derive four factors of expectation-confirmation and satisfaction and three factors of expectation-disconfirmation and dissatisfaction. Based on these findings, we provide academic and educational implications.