• 제목/요약/키워드: Crossover study

검색결과 509건 처리시간 0.03초

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
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    • 제38권5호
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    • pp.335-342
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    • 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.

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

  • 조용성;정창훈;손지영;전영신;이종태
    • 한국대기환경학회지
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    • 제23권5호
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    • pp.563-574
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    • 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.

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

  • 최돈일
    • 만화애니메이션 연구
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    • 통권32호
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    • pp.23-42
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    • 2013
  • <더 월>과 <노란 잠수함>은 핑크프로이드와 비틀즈의 음악을 바탕으로 영상을 전개하고 있다. 따라서 이번연구에서는 두 작품의 음악적 특징과 스토리텔링의 전개 방식을 상호 비교해보고자 하였다. 선행연구로는 영상의 근간인 서사와 스토리텔링에 대한 개념을 연구하였다. 본 연구인 두 작품 간의 비교연구는 첫째, 각각의 작품에서 등장하는 인물들의 역할과 관계를 중심으로 서사구조를 분석하였다. 둘째, 장르가 다른 두 음악의 특성과 음악구성의 방식을 연구하였다. 셋째, 영상전개연구는 도입부, 전개부, 결말부로 구분하고 구성된 삽입곡과 영상이 어떻게 상호작용하여 내용을 전개하는지를 비교 분석하였다. 연구 결과 <더 월>은 주관적 시선으로 강렬한 프로그레시브 록을 직유와 은유, 현재와 과거를 넘나드는 공간변화 그리고 실사와 비실사의 교차연출을 통해 주인공의 소외의식을 공간에 의한 사물적 스토리텔링구조로 풀어내고 있었다. 반면 <노란 잠수함>은 싸이키델릭한 시선으로 풀어낸 전위적 판타지영상을 선악의 대결구도를 통해 사랑과 평화의 메시지를 전달하는 사건적 스토리텔링구조로 전개하고 있음을 알 수 있었다.

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

  • 이재정;정재우
    • 디자인학연구
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    • 제17권3호
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    • pp.27-38
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    • 2004
  • 디자이너의 감성적$.$직관적 의사결정을 객관적으로 지원할 수 있는 컬러 코디네이션 지원 모델과 도구를 개발하기 위한 전 단계로 디자이너의 색채 사고 과정에 있어서의 효율성을 도모하고 상호간의 색채 커뮤니케이션을 도울 수 있는 컬러 그루핑 체계를 마련하였다. 이에 관한 연구의 결과를 요약하면 다음과 같다. 디자이너들의 색채 업무 효율을 높이고 디자이너간의 커뮤니케이션을 도울 수 있는 컬러 그룹의 제정과 각 그룹별 대표어휘의 필요성을 제기하여 이에 대한 대안을 제시하였다. 그루핑 방법은 고바야시와 히데끼 치지와, 그리고 엘리스 웨스트게이트와 마사 질의 이론을 참고하여 4개의 컬러 그룹으로 나누었으며 분류 방향은 색조별(톤별) 색채체계에 의한 분류가 정량적 표준 색표에 의한 분류보다 디자이너의 감성을 표현하는데 유리하다는 전제하에 섬유 색채의 특수성을 반영하여 색조별(톤별) 색채 체계를 근간으로 하였다. 각 그룹별 대표 어휘는 브라이트 , 파스텔 , 딥 , 뉴트럴로 추출$.$정의하였다. 각 그룹별 색조 개념에 대한 정의는 다음과 같다. 브라이트(Bright) - 순도 높은 기본 색상군 파스텔(Pastel) - 기본 색상 군에 화이트가 혼합된 색상군 딥(Deep) - 기본 색상 군에 블랙과 회색이 혼합된 색상군 뉴트럴(Neutral)- 기본 색상군의 성격이 드러나지 않는 중도색. 분류된 각 그룹의 추정 색상은 정시화의 색채시계와 색채 삼각형에 배치하여 색채 지각 공간에서의 분포 개념을 시각화함으로서 각 그룹별 영역 관계를 검증하였다. 4개의 대그룹으로 나누어진 색채군은 후속 연구에서 이루어질 선호 색채 수집 상황에 따라 몇 개의 소단위로 나누어지게 되며 각 소그룹의 색채군은 각 단위별로 배색 스토리를 전개할 수 있다. 또한 그룹과 그룹간의 크로스 오버 코디네이션이 가능해 짐에 따라 디자이너들은 이제까지의 개별 색상 조합의 색채 사유 패턴에서 벗어나 그룹별 색채 사유가 가능해짐으로서 디자이너들의 색채 사유 패턴의 혁신을 도모할 수 있다.

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

  • 김기홍;홍기정;함승희;최진우
    • 한국화재소방학회논문지
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    • 제32권3호
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    • pp.116-122
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    • 2018
  • 본 연구의 목적은 개발 중인 화학, 생물학, 방사능 및 원자력 특수재난 대응 격리 이송 장비의 효율성과 사용 용이성을 평가하는 것이다. 상기 개발 장비는 자체 개발한 격리, 이송, 환자 감시 모듈을 통합하여 제작하였다. 응급구조사를 대상으로 한 마네킹을 이용한 무작위 교차 실험(또는 시뮬레이션)연구이며, 모든 연구대상자는 기존 장비와 특수재난 대응 격리 이송 장비의 시제품을 교대로 사용하였다. 생체신호 변화 검출 소요 시간과 치료 적용 소요 시간으로 효율성을 평가하였고 각 감시장치, 이송카트, 격리 장치 편의성에 대한 설문조사를 통해 사용 편의성으로 평가하였다. 총 12명의 응급구조사가 연구에 참여하였고 특수재난 대응 격리 이송 장비 군의 저산소증 검출 시간이 3.5초(2.5-3.9)로 기존 장비군의 4.9초(3.8-3.9)보다 유의하게 짧았다(p < 0.05). 심전도 변화 감지 소요 시간 및 안면 마스크 산소 공급 소요 시간의 감소 경향은 있었으나 통계적 유의성은 관찰되지 않았다. 특수재난 대응 격리 이송 장비 군의 환자 감시 장치의 전반적 만족도도 특수재난 대응 격리 이송 장비 군이 4점(3.5-5)으로 기존 장비군의 3점(3-3)에 비해 높았다(p < 0.05). 특수재난 대응 격리 이송 장비 사용군이 저산소증 검출 시간이 짧았으며 기존장비에 비해 환자 감시 장치의 전반적 만족도가 높은 것을 확인하였다.

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

  • 김윤정;홍미숙
    • 한국산학기술학회논문지
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    • 제20권2호
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    • pp.368-377
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    • 2019
  • 본 연구는 전문대학이 직업교육 훈련 기관으로써 더욱 효과적으로 활성화될 수 있도록 현재 운영 과정에 대해 살펴보고 개선점을 제안하기 위하여 시도되었다. 연구 대상자는 서울과 경기 지역의 전문대에서 미용계열 직업교육 훈련과정을 수료하였거나 재학 중인 250명을 대상으로 자료 수집을 실시하여 부적절한 응답을 제외한 총 230부를 분석하였다. 자료 분석은 설문조사에서 회수된 설문지 응답 결과를 통계 패키지 프로그램인 SPSS Statistics (Ver. 24: IBM, USA)를 이용하여 분석하였다. 본 연구에서 자료의 특성을 살펴보기 위하여 빈도 분석을 실시하였고, 범주 형 자료 간의 연관성을 살펴보기 위하여 교차분석을 주로 실시하였다. 연구 결과 첫째, 고등학교 1학년 학기 초 일반고 전교생들에게 직업교육 훈련과정에 대한 정보를 일률적으로 제공하고, 이후 2학년 1학기부터 충분한 직업교육 훈련시간을 통해 본인의 적성에 부합한 진로를 결정할 수 있게 하는 것이다. 둘째, 미용계열 훈련과정에 네 개의 전공과목을 동시에 개설하는 것이다. 훈련생들이 네 개의 미용 과목에 따른 자격증을 훈련기관에서 훈련기간 중 취득할 수 있게 하며. 피부, 헤어, 메이크업, 네일아트의 모든 전공과목을 교육 받고 자격증을 취득하는 과정에 본인의 적성에 부합한 전공 진로를 신중히 결정할 수 있게 기회를 갖는 것이다. 이러한 결과를 바탕으로 전문대가 미용을 전공으로 하는 일반고 비진학 학생들에게 효율적인 직업교육 훈련기관으로 더욱 활성화될 수 있는 방안을 제안하였다.

요통 유무에 따른 20대 성인의 넙다리뒤근에 적용한 두 가지 근에너지 기법 종류에 따른 골반 경사각 및 넙다리뒤근 길이에 미치는 즉각적 효과 비교 (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)

  • 황리경;김선엽
    • 한국전문물리치료학회지
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    • 제29권1호
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    • pp.37-47
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    • 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.

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

  • 최진경;김주연
    • 한국생활환경학회지
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    • 제24권5호
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    • pp.654-664
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    • 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.

Effects of Cardiotonic Pills® on Cerebrovascular CO2 Reactivity and Erythrocyte Deformability in Normal Subjects: A Pilot Study

  • Sang-Kwan Moon;Han-Gyul Lee;Seungwon Kwon;Seung-Yeon Cho;Seong-Uk Park;Woo-Sang Jung;Jung-Mi Park;Chang-Nam Ko;Ki-Ho Cho
    • 대한한의학회지
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    • 제44권4호
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    • pp.87-103
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    • 2023
  • Backgrounds and objectives: Cardiotonic Pills® (CP) are used for vascular diseases such as coronary diseases, atherosclerosis, and cerebral infarction. This study aimed to determine the transient effects of CP on cerebrovascular CO2 reactivity (CVR) and erythrocyte deformability in normal subjects. Methods: This study had a crossover design and included 10 participants who were randomly allocated to 2 groups. The experimental group was given CP with water, while the control group was given only water. CVR was measured by hyperventilation-induced CVR of the middle cerebral artery (MCA) using transcranial Doppler (TCD). Erythrocyte deformability was measured using a Rheoscan-D microfluidic ektacytometer. All measurements were performed prior to and 1, 2, and 3 hours after CP or water administration. Blood pressure and heart rate were also measured before and after administration. Results: CP significantly improved CVR 3 hours after administration in the experimental group compared to the control group (p = 0.042). The corrected blood flow velocity at partial pressure of end-tidal carbon dioxide (PETCO2) = 40mmHg (CV40) was also significantly improved 2 and 3 hours after administration in the CP group compared to the control group (p = 0.036 and p = 0.021, respectively). CP significantly improved erythrocyte deformability 3 hours after administration in the experimental group compared to the control group (p = 0.027). Mean heart rate and mean blood pressure showed no change. Conclusions: This study demonstrated that CP increases CVR and erythrocyte deformability. These results suggested that CP improves cerebral microcirculation which provide evidence for the future use of CP for prevention of ischemic stroke and neurodegenerative diseases.

건강한 한국인 피험자에서 Cefcapene Pivoxil Hydrochloride 75 mg 제제의 생물학적동등성시험 (Pharmacokinetic Properties and Bioequivalence of Cefcapene Pivoxil Hydrochloride 75 mg in Korean Healthy Volunteers)

  • 전지영;임용진;황민호;김윤정;한수미;조명진;김희선;김선영;김강석;채수완;김민걸
    • 한국임상약학회지
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    • 제22권1호
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    • pp.9-12
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    • 2012
  • Background: Cefcapene pivoxil hydrochloride, is an ester-type oral cephem antibiotic. This study was performed to compare the pharmacokinetics and evaluate the bioequivalence of two cefcapene pivoxil hydrochloride 75 mg formulations. Method: In a randomized $2{\times}2$ crossover study, sixty healthy male volunteers were randomly assigned into two groups. After a single dose of 75 mg cefcapene pivoxil hydrochloride oral administration, blood samples were collected at specific time intervals from 0-12 hours. The plasma concentrations of cefcapene pivoxil hydrochloride were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The pharmacokinetic parameters such as $AUC_{last}$, $AUC_{inf}$ and $C_{max}$, were calculated and the 90% confidence intervals for test/reference ratio for pharmacokinetic parameters were obtained by analysis of variance on logarithmically transformed data. Results: The mean value for $AUC_{last}$ in test and reference drug was $4053.1{\pm}876.5\;ng{\cdot}hr/mL$ and $3595.7{\pm}1029.1\;ng{\cdot}h/mL$, respectively. The mean value for $C_{max}$ in test and reference drug was $1324.9{\pm}321.4$ ng/mL and $1159.1{\pm}335.9$ ng/mL, respectively. The 90% confidence intervals of the $AUC_{last}$ and $C_{max}$ ratio for test drug and reference drug were log 1.09-log1.22 and log 1.09-log1.24, respectively. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. Conclusion: This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in these health volunteers. Both formulations were safe and well tolerated in 75 mg of cefcapene pivoxil hydrochloride.