• Title/Summary/Keyword: Zero-variance

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Bioequivalence of LANIDIEM® Tablet 4 mg to Vaxar® Tablet 4 mg(Lacidipine 4 mg) (박사르®정 4 밀리그램(라시디핀 4 mg)에 대한 라니디엠®정 4 밀리그램의 생물학적동등성)

  • Lee, Yun-Young;Kim, Hye-Jin;La, Sookie;Cho, Kyung-Hee;Jang, Moon-Sun;Park, Young-Joon;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.40 no.2
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    • pp.125-131
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    • 2010
  • A bioequivalence study of LANIDIEM$^{(R)}$ tablet 4 mg (Samil. Co., Ltd.) to Vaxar$^{(R)}$ tablet 4 mg (GlaxoSmithKline Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Forty healthy male Korean volunteers were enrolled in the study and thirty six volunteers completed the study according to the protocol. Thirty six volunteers received each medicine at the lacidipine dose of 4 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of lacidipine were monitored by a high performance liquid chromatography - tandem mass spectrometry (LC-MS/MS) for over a period of 24 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 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 LANIDIEM$^{(R)}$/Vaxar$^{(R)}$ were log 0.8102~log 1.0417 and log 0.8493~log 1.1439, respectively. These values were within the acceptable bioequivalence intervals of log 0.80~log 1.25. Thus, our study demonstrated the bioequivalence of LANIDIEM$^{(R)}$ tablet 4 mg and Vaxar$^{(R)}$ tablet 4 mg with respect to the rate and extent of absorption.

Bioequivalence of RoxithrinTM Tablet to RulidTM Tablet (Roxithromycin 150 mg) (루리드 정(록시스로마이신 150 mg)에 대한 록시스린 정의 생물학적동등성)

  • Joung, Sun-Koung;Lee, Yun-Young;Cho, Tae-Seob;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.34 no.3
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    • pp.209-214
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    • 2004
  • A bioequivalence study of $Roxithrin^{TM}$ tablet (Kukje Pharma. Ind. Co., Ltd.) to $Rulid^{TM}$ tablet (Han Dok Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the roxithromycin dose of 300 mg in a $2{\times}2$ crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography for over a period of 36 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 36 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 cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Roxithrin^{TM}/Rulid^{TM}$ were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of $Roxithrin^{TM}$ and $Rulid^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of EtodolTM Tablet to KuhnillodineTM Tablet (Micronized Etodolac 200 mg) (건일로딘 정(미결정에토돌락 200 mg)에 대한 에토돌 정의 생물학적동등성)

  • Lee, Jung-Ae;Lee, Yun-Young;Cho, Tae-Seob;Park, Young-Joon;Moon, Byoung-Seok;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.4
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    • pp.319-325
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    • 2004
  • A bioequivalence of $Etodol^{TM}$ tablets (Yuhan corporation) and $Kuhnillodine^{TM}$ tablets (Kuhnil Pharm. Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 mg dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2{\times}2$ crossover design. Concentrations of etodolac in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 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 performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Etodol^{TM}/Kuhnillodine^{TM}$ were 1.01-1.10 and 0.87-1.06, respectively. This study demonstrated a bioequivalence of $Etodol^{TM}$ and $Kuhnillodine^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of BestidineTM Tablet to Dong-A GasterTM Tablet (Famotidine 20 mg) (동아가스터 정(파모티딘 20 mg)에 대한 베스티딘 정의 생물학적동등성)

  • Park, Chang-Hun;Joung, Sun-Koung;Choi, Mee-Hee;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.6
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    • pp.505-511
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    • 2004
  • A bioequivalence study of $Bestidine^{TM}$ tablets (Choong Wae Pharma. Corp., Korea) to Dong-A $Gaster^{TM}$ (Dong-A Pharmaceutical Co., Ltd., Korea) tablets was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the famotidine dose of 40 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of famotidine were monitored by a high-performance liquid chromatography for over a period of 12 hours 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 Cmax ratio for $Bestidine^{TM}/Gaster^{TM}$ were log 0.90-log 1.06 and log 0.98-log 1.20, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Bestidine^{TM}$ and $Gaster^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of Atorva Tablet® to Lipitor Tablet® (Atorvastatin 20 mg) (리피토정® (아토르바스타틴 20 mg)에 대한 아토르바정®의 생물학적동등성)

  • Lim, Hyun-Kyun;Lee, Tae-Ho;Lee, Jae-Hyun;Youm, Jeong-Rok;Song, Jin-Ho;Han, Sang-Beom
    • Journal of Pharmaceutical Investigation
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    • v.38 no.2
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    • pp.135-142
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    • 2008
  • The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor $Tablet^{(R)}$ (Pfizer, reference drug) and Atorva $Tablet^{(R)}$ (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a $2{\times}2$ crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were complied trom 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 Atorva $Tablet^{(R)}$ / Lipitor $Tablet^{(R)}$ were ${\log}\;0.9413{\sim}{\log}\;1.0179$ and ${\log}\;0.831{\sim}{\log}\;1.0569$, respectively. These values were within the acceptable bioequivalence intervals of ${\log}\;0.8{\sim}{\log}\;1.25$. Based on these statistical considerations, it was concluded that the test drug, Atorva $Tablet^{(R)}$ was bioequivalent to the reference drug, Lipitor $Tablet^{(R)}$.

Marginal Effect Analysis of Travel Behavior by Count Data Model (가산자료모형을 기초로 한 통행행태의 한계효과분석)

  • 장태연
    • Journal of Korean Society of Transportation
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    • v.21 no.3
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    • pp.15-22
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    • 2003
  • In general, the linear regression model has been used to estimate trip generation in the travel demand forecasting procedure. However, the model suffers from several methodological limitations. First, trips as a dependent variable with non-negative integer show discrete distribution but the model assumes that the dependent variable is continuously distributed between -$\infty$ and +$\infty$. Second, the model may produce negative estimates. Third, even if estimated trips are within the valid range, the model offers only forecasted trips without discrete probability distribution of them. To overcome these limitations, a poisson model with a assumption of equidispersion has frequently been used to analyze count data such as trip frequencies. However, if the variance of data is greater than the mean. the poisson model tends to underestimate errors, resulting in unreliable estimates. Using overdispersion test, this study proved that the poisson model is not appropriate and by using Vuong test, zero inflated negative binomial model is optimal. Model reliability was checked by likelihood test and the accuracy of model by Theil inequality coefficient as well. Finally, marginal effect of the change of socio-demographic characteristics of households on trips was analyzed.

The Effects of Sentiment and Readability on Useful Votes for Customer Reviews with Count Type Review Usefulness Index (온라인 리뷰의 감성과 독해 용이성이 리뷰 유용성에 미치는 영향: 가산형 리뷰 유용성 정보 활용)

  • Cruz, Ruth Angelie;Lee, Hong Joo
    • Journal of Intelligence and Information Systems
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    • v.22 no.1
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    • pp.43-61
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    • 2016
  • Customer reviews help potential customers make purchasing decisions. However, the prevalence of reviews on websites push the customer to sift through them and change the focus from a mere search to identifying which of the available reviews are valuable and useful for the purchasing decision at hand. To identify useful reviews, websites have developed different mechanisms to give customers options when evaluating existing reviews. Websites allow users to rate the usefulness of a customer review as helpful or not. Amazon.com uses a ratio-type helpfulness, while Yelp.com uses a count-type usefulness index. This usefulness index provides helpful reviews to future potential purchasers. This study investigated the effects of sentiment and readability on useful votes for customer reviews. Similar studies on the relationship between sentiment and readability have focused on the ratio-type usefulness index utilized by websites such as Amazon.com. In this study, Yelp.com's count-type usefulness index for restaurant reviews was used to investigate the relationship between sentiment/readability and usefulness votes. Yelp.com's online customer reviews for stores in the beverage and food categories were used for the analysis. In total, 170,294 reviews containing information on a store's reputation and popularity were used. The control variables were the review length, store reputation, and popularity; the independent variables were the sentiment and readability, while the dependent variable was the number of helpful votes. The review rating is the moderating variable for the review sentiment and readability. The length is the number of characters in a review. The popularity is the number of reviews for a store, and the reputation is the general average rating of all reviews for a store. The readability of a review was calculated with the Coleman-Liau index. The sentiment is a positivity score for the review as calculated by SentiWordNet. The review rating is a preference score selected from 1 to 5 (stars) by the review author. The dependent variable (i.e., usefulness votes) used in this study is a count variable. Therefore, the Poisson regression model, which is commonly used to account for the discrete and nonnegative nature of count data, was applied in the analyses. The increase in helpful votes was assumed to follow a Poisson distribution. Because the Poisson model assumes an equal mean and variance and the data were over-dispersed, a negative binomial distribution model that allows for over-dispersion of the count variable was used for the estimation. Zero-inflated negative binomial regression was used to model count variables with excessive zeros and over-dispersed count outcome variables. With this model, the excess zeros were assumed to be generated through a separate process from the count values and therefore should be modeled as independently as possible. The results showed that positive sentiment had a negative effect on gaining useful votes for positive reviews but no significant effect on negative reviews. Poor readability had a negative effect on gaining useful votes and was not moderated by the review star ratings. These findings yield considerable managerial implications. The results are helpful for online websites when analyzing their review guidelines and identifying useful reviews for their business. Based on this study, positive reviews are not necessarily helpful; therefore, restaurants should consider which type of positive review is helpful for their business. Second, this study is beneficial for businesses and website designers in creating review mechanisms to know which type of reviews to highlight on their websites and which type of reviews can be beneficial to the business. Moreover, this study highlights the review systems employed by websites to allow their customers to post rating reviews.

A Study on Sea Water and Ocean Current in the Sea Adjacent to Korea Peninsula -The Vertical Structure of Temperatures in the East Sea of Korea- (한반도 근해의 해류 및 해수특성 -한국 동해의 수온의 수직구조-)

  • NA Jung-Yul;LEE Seong-Wook;CHO Kyu-Dae
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.24 no.4
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    • pp.215-228
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    • 1991
  • In the East Sea of Korea the vertical structure functions of the temperature field were evaluated and the characteristic thermal zone was classified by the use of the empirical orthogonal function(EOF) method. The East Sea of Korea within the hydrographic lines of 10-107 of the Fisheries Research and Development Agency of Korea(FRDA) can be divided into three thermal regions by the characteristics of the vertical temperature variability. They are the North Korean Cold Current(NKCC) region near the coast which extends parallel to the north-south direction, the Warm-Core(WC) region which dominates almost all the hydrographic stations of the Line 104 of the FRDA and occupies a few stations of the Line-103 and -105 with its axis at the Line 104, and the East Korea Warm Current(EKWC) region which is bisected into the northern and the southern part by the WC region, respectively. Considering the two most important modes, $85.20-98.20\%$ of the total variance of temperature variation are explained in the NKCC region, $85.20-92.90\%$ in the EKWC region, and$85.50-91.70\%$ in the WC region. The first mode has its peak value at the surface with the annual cycle of variation. The spatial pattern of the first mode portrays a coherent vertical variation in the EKWC region and a clear anti-correlation both in the NKCC region and in the WC region where the zero-crossing depths are loom and 200m, respectively. The second mode of the NKCC region is particularly noticeable, haying its peak at loom with coherent vertical variation. To study the time dependency of the vertical structure functions, the extended EOF(EEOF) method was used. The persistence of the first mode is less than 4 months in the study area. The annual variation of the first mode in the NKCC region is different from those in the WC region and in the EKWC region.

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