Kim, Yong-Won;Park, Wan-Su;Kim, Sung-Su;Seo, Ji-Hyung;Cho, Sung-Hee;Lee, Heon-Woo;Rew, Jae-Hwan;Lee, Kyung-Tae
Journal of Pharmaceutical Investigation
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v.36
no.2
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pp.131-136
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2006
The purpose of the present study was to evaluate the bioequivalence of two losartan tablets, $Cozaar^{TM}$ tablet (MSD Korea. Co., Ltd., Seoul, Korea, reference drug) and $Losartan^{TM}$ tablet (DaeWon Pharm. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets at the losartan kalium dose of 100 mg in a $2\;{\time}\;2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of losartan were monitored by an LC-MS/MS for over a period of 12 hr after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (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 $AUC_t$ 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 $Cozaar^{TM}/Losartan^{TM}$ were $log\;0.97{\sim}log\;1.12\;and\;log\;0.93{\sim}log\;1.23$, respectively. These values were within the acceptable bioequivalence intervals of $log\;0.80{\sim}log\;1.25$. Taken together, our study demonstrated the bioequivalence of $Cozaar^{TM}$ and $Losartan^TM$ with respect to the rate and extent of absorption.
A bioequivalence study of $Nimegen^{TM}$ soft capsule (Medica Korea Pharma. Co., Ltd.) to $RoAccutane^{(R)}$ soft capsule (Roche Korea Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty healthy male Korean volunteers received each medicine at the isotretinoin dose of 60 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of isotretinoin were monitored by a high performance liquid chromatography (HPLC) for over a period of 48 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48 hr) was calculated by the linear trapezoidal rule method. $C_{MAX}$ (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 $AUC_t\;and\;C_{MAX}$. 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 $Nimegen^{TM}/RoAccutane^{(R)}$ were $log0.860{\sim}log0.98\;and\;log0.85{\sim}log1.00$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Thus, our study demonstrated the bioequivalence of $Nimegen^{TM}\;and\;RoAccutane^{(R)}$ with respect to the rate and extent of absorption.
The purpose of the present study was to evaluate the bioequivalence of two pioglitazone HCl tablets, $Actos^{TM}$, tablets (Lilly Korea. Ltd., Korea) as a reference drug and $Piros^{TM}$, tablets (Reyon Pharm. Co., Ltd., Korea) as test drug, according to the guideline of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received one tablet containing pioglitazone HCl 15 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of pioglitazone were monitored for over a period of 36 hr after administration by using a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The area under the plasma concentration-time curve from time zero to 36 hr ($AUC_{0-36hr}$), maximum plasma drug concentration ($C_{max}$) and time to reach $C_{max}$ ($T_{max}$) 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 $AUC_{0-36hr}$ and $C_{max}$. The 90% confidence intervals of the $AUC_{0-36hr}$ ratio and the $C_{max}$ ratio for $Piros^{TM}$/$Actos^{TM}$. were log 0.8753-log 1.1286 and log 0.8669-log 1.1734, 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 the $Piros^{TM}$. tablet was bioequivalent to the $Actos^{TM}$. tablet, based on the rate and extent of absorption.
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.
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.
Purpose - The current analysis has been done in order to verify the difference between consumer attitudes on the distributor's PB products in terms of practical shopping value and attitudes about the product according to its perceived quality. Research design, data, and methodology - The target respondents of this study were those who have bought PB products at large-scale discount stores within the past six months. We asked homemakers, office workers, and students who live in Seoul or Daejon to respond to a questionnaire by filling out self-evaluations, and collected the completed questionnaires. To test the hypothesis, a t-test was carried out by group for 25 percent of the high and low rankings, including a quarter of the total respondents, to verify attitudes toward products and brands, purchase satisfaction, and re-purchase intention according to the practical shopping value and recognized quality of PB products. A variance analysis was conducted to see if there were differences among groups in terms of practical shopping value and perceived quality. Scheffe's back testing was used to identify differences between groups. Results - The result of the investigation of consumer attitudes according to practical shopping value is as follows. First, it was verified that consumer attitudes about PB products increase as practical shopping value increases. Second, there was no significant. Third, it was verified that repurchase intentions for PB products get higher as the practical shopping value of the consumer increases. The following is the result of the investigation of consumer attitudes according to the perceived quality of PB products. First, it was verified that the product attitude improves as the perceived quality of PB products increases. Second, the research confirmed that the brand attitude improves as the perceived quality of PB products increases. Third, consumer satisfaction is higher when the perceived quality of PB products is high. Fourth, this study verified that repurchase intentions for PB products are higher as the perceived quality of the product increases. Finally, the results of identifying differences between groups for perceived quality and shopping value are as follows. It was identified that there were differences in shopping value according to the characteristics of the groups. However, perceived quality does not change according to the characteristics of groups. Conclusions - These results have practical implications for the marketing strategy of PB products in order to satisfy consumer demands and provide a differentiated service by the distributor. In addition, it is suggested that a communication strategy may be necessary to increase brand loyalty and ensure the continual growth and value creation of PB products as symbolic products for distributors.
Journal of the Korea Academia-Industrial cooperation Society
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v.19
no.4
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pp.178-185
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2018
The low birth rate in South Korea is a very serious problem. Recently, as personal happiness has emerged as an important life value of life, unmarried people have developed a negative tendency toward marriage. This study was conducted to investigate the attitude toward marriage, gender role and having children among college students, and to identify the factors affecting marriage. The participants were 383 unmarried nursing college students who live in D city. Data were collected from self-report questionnaires and analyzed using the t-test, one-way ANOVA, Pearson's correlation coefficients, and stepwise multiple regression using the SPSS 22.0 program. Gender was a significant variable influencing attitude toward marriage. Moreover, the attitude toward marriage was negatively correlated with gender role, and positively correlated with having children. Attitude toward gender role was negatively correlated with having children. Regression analysis of the factors affecting attitude toward marriage showed that gender (male), attitude toward gender role, and attitude toward having children were significant influencing factors. Moreover, this model explained 51.9% of variance in attitude toward marriage. Overall, it is necessary to change individual values to solve the problem of low birthrate.
This study develops an indicator to manage regional variations of approval rates for long-term care (LTC) service. We used LTC insurance data for grade assessment that include 433,155 applicants from 227 LTC centers across Korea in 2015. The approval rate for each center was defined as the proportion of the numbers of approved applicants out of all applicants. We assumed that the approval rates depended on the characteristics of applicants. We estimated the 'standard' approval rates from a multiple linear regression analysis using the characteristics of applicants as independent variables. The difference between the observed and the standard rates was then defined as an indicator for deviation. A center having a large difference could be considered as a center with a potential error in grade assessment. We also examined if the characteristics of investigators affected the approval rates. We found that the socio-demographic characteristics of applicants and reapplication rate for LTC grade were independent factors affecting the approval rates. Centers having the management indicator values falling outside the middle 95% of the distribution were identified as centers with an error in grading. We expect that this study will contribute to enhancing reliability and equity in LTC grading.
This paper solves the problem in underdetermined convolutive mixture by improving the disadvantages of the multichannel nonnegative matrix factorization technique widely used in blind source separation. In conventional researches based on Spatial Covariance Matrix (SCM), each element composed of values such as power gain of single channel and correlation tends to degrade the quality of the separated sources due to high variance. In this paper, level and frequency normalization is performed to effectively cluster the estimated sources. Therefore, we propose a novel SCM and an effective distance function for cluster pairs. In this paper, the proposed SCM is used for the initialization of the spatial model and used for hierarchical agglomerative clustering in the bottom-up approach. The proposed algorithm was experimented using the 'Signal Separation Evaluation Campaign 2008 development dataset'. As a result, the improvement in most of the performance indicators was confirmed by utilizing the 'Blind Source Separation Eval toolbox', an objective source separation quality verification tool, and especially the performance superiority of the typical SDR of 1 dB to 3.5 dB was verified.
Major cities have strengthened their efforts to improve the environmental function of the urban forest through aspects of quantity and quality. Yet, it is difficult to propose both long-term improvement and management policy direction continuously due to a lack of evaluating method that social needs could be reflected. After all, effective strengthening of the function of an urban forest, composed of social and biotic environments, is essential to create evaluation criteria. Such data reflects a quantity variation and identifies the distribution and habitation of biotic sources as well. An assessment of utilization possibilities presents such values as a green connectivity, an ecological healthiness, and usage and access opportunities. Consequently, this research was executed to create an urban forest sustainability index that proposes a management and policy direction based on the evaluation of quantity and quality aspects. This study was processed by the following steps: a degree of importance of ecological aspect, a sub-classification index choice, and an examination of adequacy. This research was conducted from premises that urban forest had another functions comparisons to a natural forest. As a result, a criteria of sustainability should be considered to evaluate an ecological aspect, as well as the social and management aspects regarding human disturbance. This research is designed to develop an evaluation index for ecological aspect. In order to evaluate the ecological healthiness of an urban forest, a vegetation index considers aspects of related rarity, damage possibility, naturalness, area, and diversity. In a wildbird index-related study, forest duration and area were selected. Finally, a variance analysis is presented, inclusive of stability, naturalness, diversity, potentiality, and possibility of wildlife inhabitation, which is indicative of an urban forest sustainability index.
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