• Journal of Pharmaceutical Investigation
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• v.39 no.1
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• pp.65-71
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• 2009

The aim of the present study was to evaluate the bioequivalence of two domperidone maleate tablets, Motilium-$M^{(R)}$ Tablet (Janssen Korea Ltd., reference product) and $Toriem^{(R)}$ Tablet (Daewon Pharm. Co., Ltd., test product). Domperidone was extracted by liquid-liquid extraction using tert-butyl methyl ether and separated in less than 3 min on $C_{18}$ reverse-phase column using an isocratic elution. A tandem mass spectrometer, as detector, was used for quantitative analysis in positive mode by a multiple reaction monitoring mode to monitor the m/z $426.1{\rightarrow}119.1$ and the m/z $837.4{\rightarrow}158.2$ transitions for domperidone and the internal standard (roxithromycin), respectively. Calibration curves, from $0.05{\sim}50$ ng/mL of domperidone, showed correlation coefficients (r) higher than 0.9941. Intra day and inter day precision (C.V. %) for quality control were ranged from 10.04 to 16.09% and from 10.87 to 18.69%, respectively. The lower limit of quantification (LLOQ) of domperidone was 0.05 ng/mL. The method described is precise and sensitive and has been successfully applied to the study of bioequivalence of domperidone in 24 healthy Korean volunteers. Twenty-four healthy male Korean volunteers received a single dose of each medicine ($2{\times}12.72\;mg$ domperidone maleate) in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of domperidone were monitored for over a period of 24 hr after the administration. $AUC_{0-t}$ (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. The 90% confidence intervals for the log transformed data were within acceptable range of log 0.8 to log 1.25 (e.g., $log\;0.92{\sim}log\;1.05$ for $AUC_{0-t}$, $log\;0.81{\sim}log\;1.05$ for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that $Toriem^{(R)}$ tablet is bioequivalent to Motilium-$M^{(R)}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.35 no.5
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• pp.323-328
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• 2005

The purpose of the present study was to evaluate the bioequivalence of two torasemide tablets, Torem tablet (Roche Korea Co., Ltd., Korea, reference drug) and Boryung Torsemide tablet (Boryung Pharmaceutical Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (furosemide) to human serum, serum samples were extracted using 5 mL of ethyl acetate. Compounds were analyzed by reverse-phase HPLC method with UV detection. This method showed linear response over the concentration range of 0.05 ug/mL with correlation coefficient of 0.999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ug/mL which was sensitive enough for pharmacokinetic studies. Twenty-eight healthy male Korean volunteers received each medicine at the torasemide dose of 20 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Serum concentrations of torasemide were monitored by an HPLC-UV for over a period of 12 hr after the administration. $AUC_{t}$(the area under the serum concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum serum drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the serum 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 Boryung Torsemide/Torem were log 0.97-10g 1.03 and log 0.93log 1.12, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Boryung Torsemide tablet and Torem tablet are bioequivalent.

• Journal of Pharmaceutical Investigation
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• v.32 no.2
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• pp.119-125
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• 2002

A rapid, selective and reproducible high-performance liquid chromatographic method has been developed for the determination of terazocin in human plasma. Terazocin plus the internal standard, prazocin hydrochloride, were extracted from alkalified plasma with tert-butylmethyl ether, back-extracted into 0.05% phosphoric acid. Fifty ${\mu}l-portions$ of extract were injected onto a octadecylsilane column and eluted with a mixture of acetonitrile, water and triethylamine (30 : 70 : 0.1 v/v, adjusted to pH 5.0 with dilute phosphoric acid) at a flow rate of 1.0 ml/min. The fluorescence intensity of column eluents was monitored at excitation wavelength of 250 nm and emission wavelength of 370 nm. No interference peaks were observed. The practical limit of quantitation was 5 ng/ml for terazocin. The average intraday and interday coefficients of variation were 4.15 and 3.54%, respectively. Also intraday and interday precisions over the range $5{\sim}60\;ng/ml$ were $0.49{\sim}2.92\;and\;0.38{\sim}5.12%$, respectively. The bioequivalence of two terazosin tablets, the $Hytrine^{\circledR}$ (Il Yang Pharmaceutical Co., Ltd.) and the $Teratonin^{\circledR}$ (Sam-A Pharmaceutical Co., Ltd.), was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers $(24.6{\pm}2.0\;years\;old)$ were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 2 mg of terazosin was orally administered, blood was taken at predetermined time intervals and the concentration of terazosin in plasma was determined with a HPLC method using spectrofluorometric detector. AUC was calculated by the linear trapezoidal method. $C_{max}\;and\;T_{max}$ were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between the two preparations were 0.21 %, 5.53% and 8.82%, respectively. The powers $(1-{\beta})\;for\;AUC_t,\;C_{max}\;and\;T_{max}$ were >99%, 97.49%, and 33.26%, respectively. Minimum detectable differences $({\Delta},\;%)\;at\;{\alpha}=0.1\;and\;1-{\beta}=0.8$ and the 90% confidence intervals were all less than ${\pm}20%$ except for $T_{max}.\;AUC_t\;and\;C_{max}$ met the criteria of KDFA for bioequivalence, indicating that $Teratonin^{circledR}$ tablets are bioequivalent to $Hytrine^{circledR}$ tablets.

• Journal of Distribution Science
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• v.10 no.12
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• pp.35-43
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• 2012

Purpose - This study analyzes the effects of types of leadership on the employees of Italian restaurants, its efficacy, and organizational citizenship behavior, utilizing a causal assessment model. In this study, independent variables such as the type of leadership perceived in the manager or chef by an Italian restaurant's employees, and its efficacy were parameters, and the organizational citizenship behavior and organizational effectiveness were the variables representing the results in the hypothesis. The study aimed to draw implications by verifying the leadership via efficacy and the impact on organizational citizenship behavior of Italian restaurants. Research design, data, methodology - For the purpose of this analysis, specific questionnaire items were configured according to the theory and efficacy of the study. From a questionnaire used in organizational citizenship behavior comprising 22 questions, six were modified to suit the research purpose of this study. The configured questionnaire comprised 5 parts and 40 items. A Likert (Likert) 5-point scale was utilized to measure responses to the questionnaire items from the employees of an Italian restaurant in Seoul who participated in the survey. For data collection, 400 questionnaires were distributed, and 344 collected. Factor analysis and reliability verification were conducted using SPSS18.0 and AMOS18.0. A covariance structure analysis was conducted to test the research hypotheses. Results - Based on the results of the analyses, the summary and suggested implications of the research are as follows: The covariance structure analysis used to analyze the kind of effect transformational and transactional leadership styles in Italian restaurant employees had on self-efficacy, group-efficacy, and organizational citizenship behavior, indicated that among the characteristics of transformational leadership (such as, idealized influence, inspirational motivation, individual consideration, and intellectual stimulation), idealized influence and individual consideration had a positive influence on self-efficacy. Idealized influence, individual consideration, conditional reward, and management by exception also positively influenced self-efficacy and altruistic and conscientious behavior (organizational citizenship behavior). Conclusions - Results suggest that with regard to self-efficacy and group efficacy, managers in different departments and chefs should provide team members with a vision for the future, increase their confidence in their abilities, and build their trust in the organization. By evaluating employee performance and experiences, management can demonstrate leadership and encourage organizational citizenship behavior through enjoyable, voluntary participation. Transformational and transactional leadership is effective in group processes that include social-exchange relationships, self-efficacy and group efficacy, and organizational citizenship behavior. However, as this research study utilizes only self-reported data, it has several limitations, such as a vulnerability of errors caused by the various experiment types. A significant limitation of this study is the lack of potential for the duplication of results. The covariance structure analysis, however, provides complementation to limit the impact of errors from self-reporting studies. A future study can extend this research by utilizing different data collection methods.

• Proceedings of the Korea Contents Association Conference
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• 2009.05a
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• pp.1141-1149
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• 2009

In Bone Mineral Density(BMD) measurements, accuracy and precision must be superior in order to know the small changes in bone mineral density and actual biological changes. Therefore the purpose of this study is to increase the reliability of bone mineral density inspection through appropriate management of image quality from machines and inspectors. For the machine management method, the recommended phantom from each bone mineral density machine manufacturer was used to take 10~25 measurements to determine the standard amount and permitted limit. On each inspection day, measurements were taken everyday or at least three times per week to verify the whether or not change existed in the amount of actual bone mineral density. Also evaluations following Shewhart control chart and CUSUM control chart rules were made for the bone mineral density figures from the phantoms used for measurements. Various forms of management became necessary for machine installation and movement. For the management methods of inspectors, evaluation of the measurement precision was conducted by testing the reproducibility of the exact same figures without any real biological changes occurring during reinspection. There were two measurement methods followed: patients were either measured twice with 30 measurements or three times with 15 measurements. An important point to make regarding measurements is that after the first inspection and any other inspection following, the patient was required to come off the inspection table completely and then get back on for any further measurements. With a 95% confidence level, the precision error produced from the measurement bone mineral figures produced a precision error of 2.77 times the minimum of the biological bone mineral density change (Least significant change: LSC). In order to assure reliability in inspection, there needs to be good oversight of machine management and measurer for machine operation and inspection error. Accuracy error in machines needs to be reduced to under 1% for scientific development in bone mineral density machines.

• Journal of The Korean Association For Science Education
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• v.37 no.2
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• pp.301-311
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• 2017

In this study, we observed the characteristics of students' small group discussions concerning the four friction problems. Participants in this study were 22 students of upper-level mechanics course and their small group discussions have been transcribed. As a result, we found that the phenomenon in this study is well defined by 'common context.' The process of formation of the common context was explicitly observed when students discussed about the identification of the problem situation (especially the movement of A in the second problem), the nature of friction and various forces, inertial frame, and noninertial reference frame. Meanwhile, the formation of common context was tacit when students thought they already had a common context. For example, students did not discuss about the friction rule itself because they had confidence about the knowledge. We also found that the presence of the questioner, receiver, and the other opinion were important for positive group discussions. The result of this study would be meaningful because it analyzed how the theme affects the group discussion beyond the limit of previous studies of just analyzing the form or pattern of discourse.

• Tuberculosis and Respiratory Diseases
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• v.50 no.6
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• pp.686-692
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• 2001

Background : Outbreaks of multidrug-resistant tuberculosis(MDR-TB) are caused by the low rate of treatment response due to limitation in number of available drugs and high rates of adverse drug side-effects. This study analysed the risk factors for MDR-TB patients, who did not respond to treatment, with an aim to improve the rate of treatment response. Methods : Retrospective study of 111 MDR-TB patients at National Mokpo Tuberculosis Hospital from Jan. 1996 to Dec. 1998 was made. The patients were separated into two groups ; group I comprised of patients who were treated successfully and group II comprised of those were not treated successfully. In order to analyze the risk factors for treatment failure, differences between the two groups were compared and the confidence limit regarding the results were tested using an independent t-test. chi-square test and a Fisher's exact test. Results : The treatment failure rate of MDR-TB patients was 32% (36 patients), and treatment success rate 68%(75 patients). This study found no significant difference between two groups in terms of age, sex, family history, extent of the disease on the chest X-ray, the number of sensitive drugs in the treatment regimen, and the number of sensitive bactericidal drugs in the treatment regimen (p>0.05). However, a past history of pulmonary tuberculosis, cavitary lesions on the chest X-ray, the number of treatments, the number of resistant drugs and the number of drugs used showed a significant difference(p<0.05). Conclusion : The rate of treatment failure in MDR-TB was increased by a past history of pulmonary tuberculosis, cavitary lesions on the chest X-ray, the number of treatments, the number of resistant drugs and the number of drugs used. For improving the treatment response of MDR-TB, every effort should be made to reduce the drug resistance caused by failure of the first treatment.

• Korean Journal of Ichthyology
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• v.30 no.3
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• pp.131-136
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• 2018

Decrease in seawater temperature during winter is one of the most important and serious issues confronted by fish net-cage aquaculture farms. This can become the cause of the manifestation of diseases and ensuing mass mortality. The present study was conducted to assess the survival rate, the range of limited low-temperature, the response of oxidative stress in the blood of red sea bream Pagrus major with decrease of water temperature. Low-lethal temperature for 7 days of P. major ($7day-LT_{50}$) was $6.54^{\circ}C$ (confidence limit: $6.31{\sim}6.71^{\circ}C$). Oxygen consumption rate was decreased with lower temperature. It showed the minimum value at the range of low-lethal temperature. Osmolality at $5^{\circ}C$ and $6^{\circ}C$ experimental group was higher significantly than control group. SOD (superoxide dismutase) activity was increased significantly at $5^{\circ}C$ experimental group compared to control group. This study data will be used to determine the appropriate area for aquaculture of red sea bream. It also manage fish net-cage farm to cope with the mass mortality occurring frequently during winter season.

• Asian Pacific Journal of Cancer Prevention
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• v.16 no.9
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• pp.3645-3651
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• 2015

Background: Previous studies evaluating the association between the xeroderma pigmentosum group G (XPG) Asp1104His polymorphism and head and neck cancer susceptibility have proven controversial. This meta-analysis of the literature was performed to obtain a more precise estimation of the relationship. Materials and Methods: We systematically searched PubMed, Embase and Web of Science with a time limit of Dec 18, 2014. Odds ratios (ORs) with 95% confidence intervals (CIs) were used to assess the strength of any association. Results: We performed a meta-analysis of eight published case-control studies, including 3,621 cases and 5,475 controls. Overall, no significant association was found between the XPG Asp1104His polymorphism and head and neck cancer susceptibility under all genetic models. In the subgroup analysis by ethnicity, the XPG Asp1104His polymorphism had statistically significant association with elevated head and neck cancer risk under CC vs GG (OR=1.24, 95% CI=1.00~1.54) and the recessive model (OR=1.22, 95%CI=1.01~1.46) in Asian populations. A similar result was found under CC vs GG (OR =1.22, 95%CI=1.01~1.47) in the population based subgroup by source of control. When performed by tumor site, the XPG Asp1104His polymorphism had statistically significant association with elevated laryngeal cancer under all genetic models (CC vs GG: OR=1.59, 95% CI=1.16~2.19; GC vs GG: OR=1.38, 95%CI=1.10~1.72; dominant model: OR=1.42, 95% CI=1.15~1.74; recessive model: OR=1.36, 95% CI=1.02~1.81). Conclusions: This meta-analysis suggested that the XPG Asp1104His polymorphism is a risk factor for head and neck cancer susceptibility, especially for laryngeal cancer and in Asian populations.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.12
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• pp.6391-6395
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• 2012

Background: Ovarian cancer is ranked as the fifth most common cause of cancer death in women. In Malaysia, it is the fourth most common cancer in females. CA125 has been the tumor marker of choice in ovarian cancer but its diagnostic specificity in early stages is only 50%. Hence, there is a critical need to identify an alternative tumor marker that is capable of detecting detect ovarian cancer at an early stage. HE4 is a new tumor marker proposed for the early diagnosis of ovarian cancer and disease recurrence. Currently, none of the normal ranges of HE4 quoted in the literature are based on data for a multiethnic Asian population. Therefore, the aim of this study was to determine reference intervals for HE4 in an Asian population presenting in University Malaya Medical Centre, a tertiary reference hospital. Materials and Methods: 300 healthy women were recruited comprising 150 premenopausal and 150 postmenopausal women, aged from 20-76 years. All women were subjected to a pelvic ultrasonograph and were confirmed to be free from ovarian pathology on recruitment. Serum HE4 levels were determined by chemiluminescent microparticle immunoassay (CMIA, Abbott Architect). The reference intervals were determined following CLSI guidelines (C28-A2) using a non-parametric method. Results: The upper limits of the $95^{th}$ percentile reference interval (90%CI) for all the women collectively were 64.6 pmol/L, and 58.4 pmol/L for premenopausal) and 69.0 pmol/L for postmenopausal. The concentration of HE4 was noted to increase with age especially in women who were more than 50 years old. We also noted that our proposed reference limit was lower compared to the level given by manufacturer Abbott Architect HE4 kit insert (58.4 vs 70 pmol/L for premenopausal group and 69.0 vs 140 pmol/L in the postmenopausal group). The study also showed a significant difference in HE4 concentrations between ethnic groups (Malays and Indians). The levels of HE4 in Indians appeared higher than in Malays (p<0.05), while no significant differences were noted between the Malays and Chinese ethnic groups. Conclusions: More data are needed to establish a reference interval that will better represent the multiethnic Malaysian population. Probably a larger sampling size of equal representation of the Malay, Chinese, Indians as well as the other native ethnic communities will give us a greater confidence on whether genetics plays a role in reference interval determination.