• Title/Summary/Keyword: Crossover study

Search Result 512, Processing Time 0.024 seconds

Rapid and Simple Method for the Determination of Pregabalin in Human Plasma using Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS): Application to a Bioequivalence Study of Daewoong Pregabalin Capsule To Lyrica® Capsule (Pregabalin 150 mg)

  • Jang, Ki-Ho;Seo, Ji-Hyung;Yim, Sung-Vin;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
    • /
    • v.41 no.4
    • /
    • pp.255-262
    • /
    • 2011
  • Method using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) was developed and validated for the determination of pregabalin in plasma samples. Acquisition was performed by monitoring the transitions: m/z 160.1${\rightarrow}$142.2 for pregabalin and m/z 423.2${\rightarrow}$207.1 for losartan (as an internal standard). After cold acetonitrileinduced protein precipitation of the plasma samples, separation was performed with C18 column by isocratic mobile phase consisted of 10 mM ammonium acetate and acetonitrile (15:85, v/v). Results were linear over the concentration ranged from 0.1 to $10{\mu}g$/mL and the correlation coefficients (r) were $\geq0.99$. Intra- and inter-day precisions were $\leq6.02$ and $\leq11.04%$, respectively, and intra- and inter-day accuracies were 96.60-101.09 and 98.10-102.60%, respectively. This validated method was successfully applied to a bioequivalence study of two formulations of pregabalin, Daewoong pregabalin capsule (Daewoong Pharm. Co., Ltd.) and Lyrica$^{(R)}$ capsule (Pfizer Korea Ltd.) in twenty eight healthy Korean volunteers. The subjects received a single oral dose of each formulation (150 mg as pregabalin) in a randomized $2{\times}2$ crossover study and plasma samples were obtained from each subject at predetermined time intervals. Then, the pharmacokinetic parameters ($AUC_{0-t}$, $C_{max}$ and $T_{max}$) were calculated and statistically analyzed to assess the differences between two formulations. The 90% confidence intervals for the log-transformed data were acceptable range of log 0.8-log 1.25 (e.g., log 1.0048-log 1.0692 for AUC0-t, log 0.9142-log 1.0421 for $C_{max}$). Thus, $AUC_{0-t}$ and $C_{max}$ met the criteria of the Korea Food and Drug Administration (KFDA) for bioequivalence test indicating that Daewoong pregabalin capsule was bioequivalent to Lyrica$^{(R)}$ capsule.

Bioequivalence Study of Toriem® Tablet to Motilium-M® Tablet (Domperidone Maleate 12.72 mg) Evaluated by Liquid Chromatography/Tandem Mass Spectrometry

  • Ryu, Ju-Hee;Choi, Sang-Jun;Lee, Myung-Jae;Lee, Jin-Sung;Kang, Jong-Min;Tak, Sung-Kwon;Seo, Ji-Hyung;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
    • /
    • v.39 no.1
    • /
    • pp.65-71
    • /
    • 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.

In vitro Dissolution and in vivo Bioequivalence Study of Controlled Release Carbamazepine Formulation (Epileptol CR® vs Tegretol CR® in Healthy Male Korean Volunteers

  • Kim, Ji-Young;Kim, Hyung-Tae;Kim, Chong-Kook
    • Journal of Pharmaceutical Investigation
    • /
    • v.38 no.5
    • /
    • pp.335-342
    • /
    • 2008
  • The bioequivalence of two carbamazepine preparations was conducted. The in vivo bioequivalence study in 20 healthy male Korean volunteers was designed by using a single dose, randomized, 2-period crossover with a 3-weeks washout period between the doses. Prior to the in vivo study, an in vitro comparative dissolution test was performed by the paddle and basket method as described in the bioequivalence guidance of the Korea Food and Drug Administration (KFDA). Based on the similar dissolution pattern between two preparations in the dissolution test, the two formulations are demonstrated to be pharmaceutically equivalent. In addition, in vivo bioequivalence test was used to reconfirm the in vitro dissolution results. In the in vivo bioequivalence study, the plasma concentrations of carbamazepine up to 144 h after the administration were determined using a validated HPLC method with UV detection and the bioequivalence between the two drug products was assessed by statistical analysis of the log transformed mean ratios of $C_{max}$, $AUC_{0-t}$ and $AUC_{0-\infty}$. The mean maximum concentration ($C_{max}$) of the test and reference were found to be $1467.0{\pm}335.8\;ng/mL$ and $1465.9{\pm}310.3\;ng/mL$, respectively. The 90% confidence intervals (C.I.) of $C_{max}$ were in the range from 0.95 to 1.05. As for the $AUC_{0-t}$ and $AUC_{0-\infty}$, test values were $110027.1{\pm}27786.4\;ng/mL{\cdpt}h$, $128807.0{\pm}34563.2\;ng/mL{\cdot}h$ and $105473.6{\pm}26496.2\;ng/mL{\cdot}h$, $125448.5{\pm}35975.5\;ng/mL{\cdot}h$, respectively. The 90% C.I. of $AUC_{0-t}$ were 0.97 to 1.10 and of $AUC_{0-\infty}$, 0.99 to 1.09 and thus were within the log 0.8-log 1.25 interval proposed by the KFDA. A two-way ANOVA showed no significant difference between the two formulations. Based on these statistical analysis, it was concluded that the test formulation is bioequivalent to the reference.

A Time-series Study on Relationship between Visibility as an Indicator of Air Pollution and Daily Respiratory Mortality (대기오염 지표로서의 시정과 일별 호흡기계 사망간의 연관성에 관한 시계열적 연구)

  • Cho, Yong-Sung;Jung, Chang-Hoon;Son, Ji-Young;Chun, Young-Sin;Lee, Jong-Tae
    • Journal of Korean Society for Atmospheric Environment
    • /
    • v.23 no.5
    • /
    • pp.563-574
    • /
    • 2007
  • There seems to be a consensus among most people that visibility impairment is the most obvious indicator of air pollution. While considerable evidence on the association between air pollution and health outcomes including death and disease have been established, based on industrial complex areas or huge urban cities, time-series, case-crossover and cohort studies, scarce literature exists on the direct evidence for the association between visibility and adverse health outcomes. Our study is assessed the effect of air pollution measured by visibility impairment on respiratory mortality over a period of six years. Relative risks in respiratory deaths were estimated by a Poisson regression model of daily deaths between $1999{\sim}2004$. Daily counts of respiratory deaths as dependent variable was modelled with daily 24-hr mean visibility measurements (kilometers) as independent variable by means of Poisson regression. This model is controlled for confounding factors such as day of weeks, weather variables, seasonal variables and $PM_{10}$. The results in this study is observed the statistically significant association between an inverse health effect and visibility during the study period for respiratory mortality (percentage change in the relative risk for all aged -0.57%, 95% Cl, $-1.01%{\sim}-0.12%$; for $0{\sim}15$ aged -7.12%, 95% Cl, $-13.29%{\sim}-0.51%$; for 65+ aged -0.43%, 95% Cl, $-0.93%{\sim}-0.06%$ per 1 km increased in visibility). The effect size was much reduced during warm season. Visibility impairment resulting from air pollution is strongly associated with respiratory mortality, especially for children may be spent at outdoor. Our result provides a quick and useful indicator for eliciting the contribution of air pollution to the excess risk of respiratory mortality in Seoul, Korea.

A Comparative Study of Storytelling between and (<더 월>과 <노란 잠수함>의 스토리텔링 비교연구)

  • Choi, Don-Ill
    • Cartoon and Animation Studies
    • /
    • s.32
    • /
    • pp.23-42
    • /
    • 2013
  • The music videos of and were made based on the music of Pink Floyd and Beatles. This study aims to compare the characteristics of the two songs in terms of music and storytelling method. Previous studies investigated the narrative structure and concept of the storytelling, which are the basis of the images. This study, a comparative study of the two songs, firstly analyzed the narrative structure focusing on the roles and relationships among characters in each song. Secondly, it investigated the method of composition structure and the characteristics of the two pieces of music of which genre is different from each other. Thirdly, it classified the images into intro part, development part, and conclusion part and analyzed by comparison how the song or images inserted in the music interacts with each other. As a result, it was found that described strong progressive rock from the subjective viewpoint through the material storytelling structure by space and it represents the alienation of the hero through simile and metaphor, spatial changes crossing the past and the present, and the actual and non-actual crossover directing. On the other hand, developed a narrative storytelling structure in which progressive fantasy images developed from the psychedelic viewpoint through the confrontation of the good and the bad to deliver the messages of love and peace.

A Study on the Color Grouping System to Fashion (섬유컬러 그루핑 체계에 관한 연구)

  • 이재정;정재우
    • Archives of design research
    • /
    • v.17 no.3
    • /
    • pp.27-38
    • /
    • 2004
  • It is important for designers to be supported with their decision-making on colours which is often based on personal distinction rather than logical dialogue that may lead to confusion within communicating with others. To help these problems and to gain productivity, we would like to propose a way to define colour grouping method. In other words, the purpose of this study is to help to improve the communication and productivity within the design and designers. The grouping was based and inspired by from the studies of Kobayashi, Hideaki Chijiawa, Allis Westgate and Martha Gill. The study of grouping is based on the "tones" of each group, as they seem to reflect a designer s sentimentalism of chosen colours the best. Each of these groups will be named Bright , Pastel ,Deep and Neutral The general concept of each groups are: - Bright: high quality of pixels of primary colour - Pastel: primary colour with white - - Deep: Primary colour with gray or black - Neutral: colours that does not include any of above Each of the colour group has been allocated into Si-Hwa Jung's colour charts and colour prism to visualize the relationships between the colour groups. These four groups and the colours included in them will be broken down to smaller groups in order to make colour palette. This would break the barrier and result in using colours in groups as well as crossover coordination. This study would result in new ways of using colurs for designers designers

  • PDF

Efficacy and Usability of Patient Isolation Transport Module for CBRN Disaster : A Manikin Simulation Study (특수재난 대응 환자 격리 이송 장비의 효율성 및 편의성 평가: 마네킹시뮬레이션 연구)

  • Kim, Ki-Hong;Hong, Ki-Jeong;Haam, Seung-Hee;Choi, Jin-Woo
    • Fire Science and Engineering
    • /
    • v.32 no.3
    • /
    • pp.116-122
    • /
    • 2018
  • In Chemical, Biological, Radiological and Nuclear (CBRN) disaster, integrated and optimized equipment package including stretcher, isolation unit, patient monitoring and treatment equipment is essential to achieve proper treatment and prevent secondary contamination. The purpose of this study was to evaluate the efficiency and ease of use of integrated CBRN disaster equipment package for disaster medical response. This study was a randomized crossover study using a manikin simulation for emergency medical technitian (EMT). All participants used the existing devices and prototype of integrated CBRN disaster equipment package alternately. Efficiency was measured by time from vital sign change to detection or treatment application. Ease was use was measured by questionnaires for each patient monitor, stretcher care and isolation unit. 12 EMTs were enrolled. hypoxia-detection time of integrated equipment group was significantly shorter than existing equipment group (4.9 s (3.8-3.9) vs 3.5 s (2.5-3.9), p < 0.05). There was decreasing tendency of ECG change detection and facial mask oxygen supply but no statistical significance was observed. Overall satisfaction of patient monitoring device in integrated equipment group was significantly higher than existing devices (4(3.5-5) vs 3(3-3), p < 0.05). The use of integrated CBRN disaster equipment package shortened the hypoxia detection time and improved usability of vital sign monitor compared to existing devices.

The Suggest for improving the operation process of vocational education and training institutions (a beauty major of the vocational college) (직업교육 훈련기관 운영과정 개선에 대한 제안 (전문대 미용계열 중심으로))

  • Kim, Yun-Jung;Hong, Mi-Sook
    • Journal of the Korea Academia-Industrial cooperation Society
    • /
    • v.20 no.2
    • /
    • pp.368-377
    • /
    • 2019
  • The purpose of this study is to examine the present operation process and to suggest the points of improvement so that vocational education and training institutions can be activated more effectively. The subjects of this study were 250 college students who completed or attended the vocational education and training course in Seoul and Gyeonggi-do, and collected 230 data, excluding inappropriate responses. Data analysis was performed by using the statistical package program SPSS Statistics (Ver. 24: IBM, USA). In this study, frequency analysis was conducted to examine the characteristics of data, and crossover analysis was conducted mainly to investigate the correlation between categorical data. The results of this study are as follows: First, it provides information about vocational education and training course to all general high school students at the beginning of the first year of high school, and then, from the first semester of the second grade, do. Second, it is to open four major courses in beauty education at the same time. This makes it possible to acquire qualifications according to four beauty courses during the training period at the training institute rather than the private education institute where private education expenses are incurred. By training all major courses in skin, hair, make-up, and nail art, you will be given the opportunity to carefully determine the major course that fits your aptitude. Based on the results of this research, we propose a plan to improve the vocational education system for vocational high school students who are majoring in cosmetology.

Comparison of the Immediate Effects of Two Types of Muscle Energy Techniques Applied to the Hamstring of Adults in Their Twenties With or Without Low Back Pain on the Pelvic Inclination and the Length of the Hamstring (요통 유무에 따른 20대 성인의 넙다리뒤근에 적용한 두 가지 근에너지 기법 종류에 따른 골반 경사각 및 넙다리뒤근 길이에 미치는 즉각적 효과 비교)

  • Hwang, Lee-kyeong;Kim, Suhn-yeop
    • Physical Therapy Korea
    • /
    • v.29 no.1
    • /
    • pp.37-47
    • /
    • 2022
  • Background: Lower back pain (LBP) is a major cause of disability and a common musculoskeletal disorder encountered at some point in life. Dysfunction of the lumbar vertebrae has been associated with decreased flexibility of the hamstrings, which exhibited a strong positive correlation with LBP. Hamstring tension affects lumbar pelvic rhythm. We aimed to activate pelvic stability with compression by Active Therapeutic Movement (ATM), muscle energy technique (MET) was applied to increase the flexibility of the hamstring. Objects: In this study, we aimed to investigate the effects of MET with ATM and general MET were applied to the hamstring of adults, who were in their twenties with nor without LBP, on their pelvic inclination and the length of their hamstring. Methods: A total of 32 subjects were briefed about the purpose of this study and agreed to participate voluntarily. Before the experiment, all subjects were pre-examined, and they were divided into an LBP group and a no lower back pain group accordingly. Thereafter, all subjects participated in both in a crossover manner. After at least one week, they switched to another group and participated in the same experiment. Results: The study results revealed that both groups demonstrated significant results in the modified active knee extension test (p < 0.01) and the sit and reach test (p < 0.01) performed to assess the hamstring flexibility; an interaction (p < 0.05) was noted. Moreover, a more significant difference was observed between the MET with ATM and the general MET. Although significant results were obtained for the pelvic inclination (p < 0.01), interaction was not noted. Conclusion: Conclusively, in this study, when the MET with ATM was applied to the two groups, there was a significant difference compared to the general MET for hamstring flexibility, but it was confirmed that there was no significant difference for the pelvic inclination.

The Analysis of Mechanism on Color Scheme and Emotional Affectivity Preferences according to Wood Material Finishing in the Cafe Images (카페 이미지에서 목재 마감재에 따른 색채배색과 감성 선호도 분석 메커니즘)

  • Choi, Jin-Kyung;Kim, Ju-Yeon
    • Journal of Korean Living Environment System
    • /
    • v.24 no.5
    • /
    • pp.654-664
    • /
    • 2017
  • The use of environmentally friendly finishing materials allows us to create a space where we can feel nature and to have stability and peace in the city center. In this paper, we examined the sensitivity of people to the three café spaces where wooden finishing materials are used in the space elements that change according to people's demands for environmentally friendly space due to pollution of living environment. First, we examined the wood and finishing materials and emotional vocabulary through literature review and previous research. Second, the values of L *, a *, b* and sR, sG and sB values were extracted by using a line spectrophotometer (Ci6X). Third, we conducted a 7 - point scale questionnaire based on the extracted 13 pairs of emotional vocabulary. Using SPSS 21, frequency analysis by descriptive statistics, crossover analysis by visiting purpose and intention, and emotional lexical factor analysis were performed. Through the study, the following points were found. First, CB (The Coffee Bean), SB (Starbucks) and HS (Hollys Coffee) showed differences in CB (65%), SB (40%) and HS (37%) in the spatial analysis. Second, CB gave color similar to the color of wall and furniture wood, but HS changed the color or brightness of wood finishing color of furniture. HS or SB showed favorable use of wood color scheme. Third, SB (26.3%) and HS (19.7%) were selected by taste. Fourth, there were differences in the items of CB, 'local-exotic' and SB 'dark-bright' in the factor value. The use of wood finishing materials differed in the atmosphere evaluation depending on the spatial factors and the color of the furniture. However, in this study, there are many factors that are insufficient in the accuracy of the ratio of the applied wood finishing material to the space element and the amount of the survey. If we further study the evaluation of emotional image according to the ratio of wood finishing materials, we think that it is necessary to study now that interest in environmentally friendly is increasing.