• Journal of Pharmaceutical Investigation
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• v.39 no.2
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• pp.141-147
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• 2009

The purpose of this study was to evaluate the bioequivalence of two nateglinide tablets, $PASTIC^{(R)}$ tablet (ILDONG Pharm. Co., Ltd., Seoul, Korea, reference drug) and $GLUNATE^{(R)}$ tablet (ILHWA. Co., Ltd., Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty-five healthy male volunteers, $23.1{\pm}2.3$ years in age and $69.2{\pm}8.8\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a tablet containing 90 mg of nateglinide was orally administrated, blood was taken at predetermined time intervals over a period of 8 hr and concentrations of nateglinide in plasma were monitored using LC-MS/MS. Pharmacokinetic parameters such as AUCt (the area under the plasma concentration-time curve from time 0 to 8 hr), $C_{max}$ (maximum plasma drug concentration) and $TC_{max}$ (time to reach $CC_{max}$) were calculated and analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$ and untransformed $T_{max}$. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $GLUNATE^{(R)}/PASTIC^{(R)}$ were ${\log}1.0782{\sim}{\log}1.1626$ and ${\log}0.9621{\sim}{\log}1.1679$, respectively. Since these values were within the acceptable bioequivalence intervals of ${\log}0.80{\sim}{\log}1.25$, recommended by KFDA, it was concluded that $GLUNATER^{(R)}$ tablet was bioequivalent to $PASTIC^{(R)}$ tablet, in terms of both rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• v.39 no.6
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• pp.457-463
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• 2009

The purpose of the present study was to evaluate the bioequivalence of meloxicam capsule, $Mobic^{TM}$ capsule( Boehringer Ingelheim Ltd., Korea) as a reference drug and $Meloxifen^{TM}$ capsule (Kukje Pharma Ind. Co., Ltd., Korea) as a test drug, according to the guidelines of Korea Food and Drug Administration(KFDA). Thirty two healthy male Korean volunteers received capsule containing meloxicam 7.5 mg in a $2{\times}2$ crossover study. There was a one-week above washout period between the doses. Plasma concentrations of meloxicam were monitored for over a period of 72 hr after administration by using a high performance liquid chromatography-tandem mass spectrometer(LC-MS/MS). $AUC_t$(the area under the plasma concentration-time curve from time zero to 72 hr), $C_{max}$(maximum plasma drug concentration) and $T_{max}$(time to reach $C_{max}$) were complied from the plasma concentration-time data. Analysis of variance(ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Meloxifen^{TM}/Mobic^{TM}$ were log 0.8605-log 0.9847 and log 0.9765-log 1.1503, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25, recommended by KFDA. In all of these results, we concluded that $Meloxifen^{TM}$ capsule was bioequivalent to $Mobic^{TM}$ capsule, based on the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• v.40 no.1
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• pp.51-57
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• 2010

Losartan potassium, 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol mono-potassium salt, is a new class of antihypertensive agents, and is an antagonist in angiotensin receptor. The purpose of the present study was to evaluate the bioequivalence of two Losartan potassium tablets, Cozaar tablet (MSD Pharmaceutical Co., Ltd.) and Losata tablet (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of losartan from the two losartan potassium formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media. Twenty eight healthy male subjects, $23.86{\pm}1.80$ years in age and $67.27{\pm}6.60\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 50 mg as losartan potassium was orally administered, blood samples were taken at predetermined time intervals, and the concentrations of losartan in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and Equiv Test/K-BE Test 2002 was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Cozaar, were -2.70%, 1.45% and 2.31% for $AUC_t$, $C_{max}$ and $T_{max}$, 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 1.25 (e.g., log 0.8852~log 1.0655 and log 0.8319~log 1.2342 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Losata tablet was bioequivalent to Cozaar tablet.

• Journal of the Korean Professional Engineers Association
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• v.20 no.3
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• pp.15-25
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• 1987

Statistical control charts are useful tools to monitor and control the manufacturing processes and are widely used in most Korean industries. Many Korean companies, however, do not always obtain desired results from the traditional control charts by Shewhart such as the X-chart, X-chart, X-chart, etc. This is partly because the quality charterstics of the process are not distributed normally but are skewed due to the intermittent production, small lot size, etc. In Shewhart X-chart, which is the most widely used one in Korea, such skewed distributions make the plots to be inclined below or above the central line or outside the control limits although no assignable causes can be found. To overcome such shortcomings in nonnormally distributed processes, a distribution-free type of confidence interval can be used, which should be based on order statistics. This thesis is concerned with the design of control chart based on a sample median which is easy to use in practical situation and therefore properties for nonnormal distributions may be easily analyzed. Control limits and central lines are given for tile more famous nonnormal distributions, such as Gamma, Beta, Lognormal, Weibull, Pareto, Truncated-normal distributions. Robustness of the proposed median control chart is compared with that of the X-chart, the former tends to be superior to the latter as the probability distribution of the process becomes more skewed. The average run length to detect the assignable cause is also compared when the process has a Normal or a Gamma distribution for which the properties of X are easy to verify, the proposed chart is slightly worse than the X-chart for the normally distributed product but much better for Gamma-distributed products. Average Run Lengths of the other distributions are also computed. To use the proposed control chart, the probability distribution of the process should be known or estimated. If it is not possible, the results of comparison of the robustness force us to use the proposed median control chart based on a normal distribution. To estimate the distribution of the process, Sturge's formula is used to graph the histogram and the method of probability plotting, $X^2$-goodness of fit test and Kolmogorov-Smirnov test, are discussed with real case examples. A comparison of the propose4 median chart and the X chart was also performed with these examples and the median chart turned out to be superior to the X-chart.

• Journal of Distribution Science
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• v.12 no.10
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• pp.85-97
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• 2014

Purpose - This study aims to clarify through which process asset specificity and supplier development project (SDP) affect performance. Cooperation, partnership, the level of information exchange, and the importance of information sharing are considered significant variables as mediators related to the process. Finally, the performance formation model of the supply chain through asset specificity and supplier development project would be suggested as being a result of this study. Research design, data, and methodology - Data collection was as follows: questionnaires were distributed to 250 companies that have business ties with H Company. The empirical study to test our hypothesis was based on statistical analysis (using SPSS 19.0 and AMOS 19.0). The hypothesis of this paper is that the asset specificity and supplier development project variables have positive effects on the following variables: mediators such as cooperation and partnership (reliability and dependence); and the cooperation and partnership variables have a positive effect on the following variables: level of information sharing, the importance of information sharing, and level of information sharing; the importance of information sharing has a positive effect on supply chain performance. We tested our hypothesized model utilizing path analysis with latent variables. Results - First, it was found that asset specificity has significant positive effects on cooperation (H1), reliability (H2), and dependability (H3). Second, it was proved that the level of comprehension on the purpose of SDP has positive effects significantly on cooperation (H4), reliability (H5), and dependability (H6). Third, the hypotheses related to cooperation were all significantly accepted. The relationships of cooperation with the level (H7) and importance (H8) of information sharing were significant. Fourth, the hypotheses related to reliability were all significantly accepted. The relationships of reliability with the level (H9) and importance (H10) of information sharing were significant. In terms of dependability, however, the hypotheses were partially accepted. The effect of dependability was significant on the importance of information sharing (H12), but insignificant on the level of information sharing (H11). Finally, the causal relationships from the level of information sharing to SCM performance (H13) and from the importance of information sharing to SCM performance (H14) were both significantly accepted. Conclusion - First, with rapid changes in the business environment, enterprises should acquire the right information to properly implement SCM. For successful SCM, firms should understand the supplier development project. Second, asset specificity and the level of comprehension on SDP have significant effects both on cooperation and partnership (reliability and dependability). Third, mediators such as cooperation, reliability, and dependability significantly affect the level and importance of information sharing. Fourth, the level and importance of information sharing have significant impacts on SCM performance. This paper makes a meaningful contribution to further the understanding of how SDP affects SCM performance. Finally, successful SCM performance is achieved by information sharing through a collaborative environment and partnership (confidence & dependence) rather than by investing only in setting up an information system.

• Journal of Distribution Science
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• v.10 no.8
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• pp.25-34
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• 2012

Understanding customer' lifestyles important for banks because it will guide in determining marketing policies, such as services, pricing, service delivery and promotion decisions. From the customer' lifestyle, banks will know what kind of customers' attitudes, interests and opinions, so they also will understand what the costumer' needs and what services needed by them. For Islamic banks, customers understanding are important because, nowadays, the competition of the banks is not only with other Islamic banks but also with the well-established conventional banks offering Islamic products or services The aims of this research paper are to describe what factors underline the customer's lifestyle of both Islamic and conventional bank, to segment the bank customers based on their lifestyles and investigate the profile of each segments, to compare the characteristics of the segments, and to identify marketing policies based on the characteristics. The population of the study is banking customers in Indonesia, in which the researchers have used judgment sampling as sample selection. There were 186 customers of Islamic banks and 244 customers of conventional bank as respondents in this study. Statistical methods employed were exploratory factor analysis and cluster analysis. The finding of the study shows that there are twelve factor underlining the customers' lifestyle, namely: factor of fashion conscious, internet usage, sports spectator, financial and technology optimism, price sensitivity, independent, compulsive housekeeper, new brand tryer community activities, opinion leader, credit usage, and homebody. In addition, for Islamic banking, there are two market segments, namely fashionable-independent and innovative-social segment. Based on the lifestyle characteristics, the first segment has higher level in factor of fashion conscious, homebody, independent, optimism and price conscious, which is therefore called fashionable-independent segment. On the other hand, the second cluster has higher level in factor of new brand tryer, community minded, sport spectator, credit user, internet usage, opinion leader, and compulsive housekeeper, which is therefore called the innovative-social segment. Furthermore, for conventional banking, there are also two segments, namely persuasive-optimistic and sensitive-independent segment. The first segment has higher level on some factors, namely: opinion leader, optimism, internet usage rate, credit usage level, sport spectator, and new brand tryer. On the other hand, the second cluster is characterized by higher level in factor of price conscious, confidence, community minded, homebody, fashion conscious, and compulsive housekeeper. Managerial implications for the management of Islamic banks could be identified in this study as follows. Firstly, the twelve lifestyle factors of this study could be an alternative view in observe Islamic banking customers. The domination of both the fashionable conscious and the internet usage factor show that the aspects are quite instrumental in perceiving the customer' lifestyles, in which reflects the importance of these two aspects to customers. Secondly, in serving their customers, Islamic banks need to understand the customer lifestyle, in which the lifestyle segments found in this study provide a guide of how their needs were reflected. Finally, by understanding the segments and the characteristics each segment of the conventional banks, Islamic banks could adjust their marketing strategies differently from the conventional banks.

• KIEAE Journal
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• v.15 no.2
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• pp.19-26
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• 2015

Purpose: Maximizing human comfort in design of medical environments depends immensely on specialized architects particularly critical care design; the study proposes Evidence-Based Design as an apparent analog to Evidence-Based Medicine. Healthcare facility designs are substantially based on the findings of study in an effort to design environments that augment care by improving patient safety and being therapeutic. On SPSS (Statistical Package for Social Science) t-test is applied to simulate two independent variables of PDR (Pre Design-Research) and POE (Post- Occupancy Evaluation). PDR is conducted on relatively new hospital Hallym University Dongtan Sacred Heart Hospital to analyse visibility from researchers' point of view, here the ICU is arranged in I-Shape. POE is applied on Dongguk University Ilsan Hospital to simulate walking on LogWare where two NS are designed based on L- Shape and Seoul St. Mary's Hospital, The Catholic University of Korea where five NS are functional for ICU Intensive Care Unit, Surgical Intensive Care Unit (SICU), Medical Intensive Care Unit (MICU), Critical Care Unit (CCU), Korean Oriental Medical Care Unit which are mostly arranged in U-Shape, and walking pattern is recognized to be in a zigzag path. Method: T-Test is applied on two dependent communication variables: walkability and visibility, with confidence interval of 95%. This study systematically analyses the Nurse Station (NS) typo-morphology, and simulates nurse horizontal circulation, by computing round route visits to patient's bed, then estimating minimum round route on LogWare stop sequence software. The visual connectivity is measured on depth map graphs. Hence the aim is to reduce staff stress and fatigue for better patients care by minimizing staff horizontal travel time and to facilitate nurse walk path and support space distribution by increasing effectiveness in delivering care. Result: Applying visibility graph and isovist field on space syntax on I- Shape, L- Shape and U- Shape ICU (SICU, MICU and CCU) configuration, I-shape facilitated 20% more patients in linear view as they stir to rise from their beds from nurse station compared to U-shape. In conclusion, it was proved that U-Shape supply minimum walking and maximum visibility; and L shape provides just visibility as the nurse is at pivot. I shape provides panoramic view from the Nurse Station but very rigorous walking.

• YAKHAK HOEJI
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• v.52 no.4
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• pp.299-305
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• 2008

Gabapentin, 1-(aminomethyl) cyclohexaneacetic acid, is a amino acid derivative, and is clinically effective in the treatment of neuropathic pain and partial seizures of epilepsy as a complementary therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin tablets, $Neurontin^{R}$ tablet 800 mg (Pfizer Pharmaceuticals Co., Ltd.) and Gabapenin tablet 800 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with 0.06 M HCI dissolution media. Twenty six healthy male subjects, $23.85{\pm}2.24$ years in age and $69.40{\pm}11.11$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 800 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution media. The 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 using logarithmically transformed $AUC_{t}$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{R}$, were 1.28%, 0.63% and 0.62% for $AUC_{t}$, $C_{max}$ and $T_{max}$, 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 1.25 (e.g., $log0.9097{\sim}log1.1598$ and $log0.8919{\sim}log1.1262$ for $AUC_{t}$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabapenin tablet 800 mg was bioequivalent to $Neurontin^{R}$ tablet 800 mg.

• The Korean Journal of Applied Statistics
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• v.30 no.3
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• pp.453-462
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• 2017

Double propensity score adjustment is an analytic solution to address bias due to incomplete matching. However, it is difficult to estimate the standard error of the estimated treatment effect when using double propensity score adjustment. In this study, we propose two bootstrap methods to estimate the standard error. The first is a simple bootstrap method that involves drawing bootstrap samples from the matched sample using the propensity score as well as estimating the standard error from the bootstrapped samples. The second is a complex bootstrap method that draws bootstrap samples first from the original sample and then applies the propensity score matching to each bootstrapped sample. We examined the performances of the two methods using simulations under various scenarios. The estimates of standard error using the complex bootstrap were closer to the empirical standard error than those using the simple bootstrap. The simple bootstrap methods tended to underestimate. In addition, the coverage rates of a 95% confidence interval using the complex bootstrap were closer to the advertised rate of 0.95. We applied the two methods to a real data example and found also that the estimate of the standard error using the simple bootstrap was smaller than that using the complex bootstrap.

• The Korean Journal of Applied Statistics
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• v.30 no.3
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• pp.377-390
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• 2017

When conducting a survey, item nonresponse occurs if the respondent does not respond to some items. Since analysis based only on completely observed data may cause biased results, imputation is often conducted to analyze data in its complete form. The panel study is a survey method that examines changes of responses over time. In panel studies, there has been a preference for using information from response values of previous waves when the imputation of item nonresponses is performed; however, limited research has been conducted to support this preference. Therefore, this study compares the performance of imputation methods according to whether or not information from previous waves is utilized in the panel study. Among imputation methods that utilize information from previous responses, we consider ratio imputation, imputation based on the linear mixed model, and imputation based on the Bayesian linear mixed model approach. We compare the results from these methods against the results of methods that do not use information from previous responses, such as mean imputation and hot deck imputation. Simulation results show that imputation based on the Bayesian linear mixed model performs best and yields small biases and high coverage rates of the 95% confidence interval even at higher nonresponse rates.