• Title/Summary/Keyword: statistical confidence

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Bioequivalence of Lucetin Capsules to Prozac Capsules (Fluoxetine 20 mg) (푸로작 캅셀(플루옥세틴 20 mg)에 대한 루세린 캅셀의 생물학적 동등성)

  • Kim, Soo-Jin;Sim, Young-Sun;Lim, Dong-Koo;Oh, In-Joon;Suh, Soon-Pal;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.29 no.2
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    • pp.151-156
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    • 1999
  • Bioequivalence of two fluoxetine capsules, the $Prozac^{\circledR}$ (Daewoong Lilly Pharmaceutical Co., Ltd.) and the $Lucetin^{\circledR}$ (Kyungdong Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Twenty normal male volunteers $(21{\sim}30\;years\;old)$ were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three capsules containing 20 mg of fluoxetine per capsule were orally administered, blood was taken at predetermined time intervals, and the concentrations of fluoxetine in serum were determined using HPLC method with UV detector. The pharmacokinetic parameters ($AUC_t$, $C_{max}$ and $T_{max}$) were calculated and ANOVA test was utilized for the statistical analysis of parameters. The results showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between two capsules based on $Lucetin^{\circledR}$ capsules were -8.01 %, -7.02% and 1.49%, respectively. The powers $(1-{\beta})$ for $AUC_t$, $C_{max}$ and $T_{max}$ were 84.72%, 96.68% and 83.06%, respectively. Detectable differences $({\Delta})$ and confidence intervals were all less than ${\pm}20%$. All the parameters above met the criteria of KFDA for bioequivalence, indicating that $Lucetin^{\circledR}$ capsule is bioequivalent to $Prozac^{\circledR}$ capsule.

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Bioequivalence of Taepyungyang Baclofen Tablet to BaclanTM Tablet (Baclofen 10 mg) (바클란 정(바클로펜 10 mg)에 대한 태평양바클로펜 정의 생물학적동등성)

  • Kang, Il-Mo;Ryu, Ju-Hee;Lee, Heon-Woo;Seo, Ji-Hyung;Lee, Hyun-Soo;Lee, Myung-Jae;Choi, Sang-Jun;Kang, Jin-Yang;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.37 no.4
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    • pp.249-254
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    • 2007
  • The purpose of the present study was to evaluate the bioequivalence of two baclofen tablets, $Baclan^{TM}$ tablet (Yooyoung Pharm. Co., Ltd., Seoul, Korea, reference drug) and Taepyungyang Baclofen tablet (Pacificpharma Corporation, Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received three tablets containing baclofen 10 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of baclofen were monitored for over a period of 24 hr after the administration by using an LC-MS/MS. $AUC_t,\;C_{max}\;and\;T_{max}$ were compiled 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 $AUC_t$ and the $C_{max}$ for Taepyungyang $Baclofen/Baclan^{TM}$ were $log0.92{\sim}log1.06\;and\;log1.03{\sim}log1.22$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. It was concluded that Taepyungyang Baclofen tablet was bioequivalent to $Baclan^{TM}$ tablet, in terms of both rate and extent of absorption.

Effect of LCSI- based self-growth program on self-efficacy, adjustment to college life of undergraduates (LCSI를 활용한 자기성장 프로그램이 대학생의 자기 효능감, 대학생활 적응에 미치는 효과)

  • Choi, Young-Sil
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.15 no.6
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    • pp.3469-3477
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    • 2014
  • This study examined the effects of a 4 week, 8 session LCSI programs on the self-efficacy, adjustment to college of undergraduates. The number of participants was 39 students at one region. For statistical analysis, descriptive statistics, paired t-test, and Pearson correlation were used with SPSS WIN 18.0. The results are summarized as follows. The self-efficacy and underlying factors of self-efficacy in self-confidence, sense of self-regulated, task difficulty increased significantly, and the underlying factors of adjustment to college life academically, socially, emotionally, physically, love of the university, and adjustment to college increased significantly. Therefore, the self-growth program using LCSI, self-efficacy and adjustment to college life appears to have significant effects, and the LCSI program is more useful to consider the characteristics of each person by applying a range of situations to plan and deliver, such as communication or subjects, and conflict management in a variety of situations.

Effects of calcium intake, milk and dairy product intake, and blood vitamin D level on osteoporosis risk in Korean adults: analysis of the 2008 and 2009 Korea National Health and Nutrition Examination Survey

  • Hong, Heeok;Kim, Eun-Kyung;Lee, Jung-Sug
    • Nutrition Research and Practice
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    • v.7 no.5
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    • pp.409-417
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    • 2013
  • This study was performed to determine the effects of dietary calcium (Ca) intake, milk and dairy product intake, and serum vitamin D level on bone mineral density. The survey data from the 2008-2009 Korea National Health and Nutrition Examination Survey (KNHANES) for adults (3,819 males, 5,625 females) aged > 20 years were examined; osteoporosis was defined according to the standards for Asian populations (T-score < -2.5). The risk for osteoporosis significantly decreased as Ca intake increased; this effect persisted (quartile 4 vs. quartile 1 of Ca intake: odds ratio [OR] 0.66; 95% confidence interval [CI]: 0.50-0.87) even after adjustment for gender, age, and other factors (body mass index, serum vitamin D, menstruation, female hormone intake, menopausal status, and the number of days per week of muscular strength exercise). Additionally, the risk for osteoporosis significantly decreased as the Ca/P ratio increased (quartile 4 vs. quartile 1: OR 0.76; 95% CI: 0.58-0.98). The degree of risk was 0.96 (0.66-1.38) in those who consumed < 1 portion of milk or dairy products daily, and 0.71 (0.53-0.96) in those who consumed > 1 portion per day, compared with those who had zero intake. The risk for osteoporosis significantly decreased as the serum 25(OH) vitamin D level increased. From these results, we advocate an increase in Ca, milk, and dairy product intake, and that serum 25(OH) vitamin D levels be maintained within the normal range, for the maintenance of bone health and the prevention of osteoporosis in adults.

Effects of Meteorological and Oceanographic Properties on Variability of Laver Production at Nakdong River Estuary, South Coast of Korea (낙동강 하구 해양환경 및 기상 요인이 김P(orphyra yezoensis) 생산량 변화에 미치는 영향)

  • Kwon, Jung-No;Shim, JeongHee;Lee, Sang Yong;Cho, Jin Dae
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.46 no.6
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    • pp.868-877
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    • 2013
  • To understand the effects of marine environmental and meteorological parameters on laver Porphyra yezoensis production at Nakdong River Estuary, we analyzed marine environmental (water temperature, salinity, nutrients, etc.) and meteorological properties (air temperature, wind speed, precipitation, sunshine hours) with yearly and monthly variations in laver production over 10 years (2003-2013). Air and water temperature, wind speed, sunshine hours and precipitation were major factors affecting yearly variability in laver production at the Nakdong River Estuary. Lower air and water temperatures together with higher levels of nutrients and sunshine and stronger wind speeds resulted in higher laver harvests. Salinity and nitrogen did not show clear correlations with laver production, mainly due to the plentiful supply of nitrogen from river discharge and the low frequency of environmental measurements, which resulted in low statistical confidence. However, environmental factors affecting monthly laver production were related to the life cycle (culturing stage) of Porphyra yezoensis and were somewhat different from factors affecting annual laver production. In November, a young laver needs lower water temperatures for rapid growth, while a mature laver needs much stronger winds and more sunshine, as well as lower temperatures for massive production and effective photosynthesis, mostly in December and January. However, in spring (March), more stable environments with fewer fluctuations in air temperature are needed to sustain the production of newly deployed culture-nets ($2^{nd}$ time culture). These results indicate that rapid changes in weather and marine environments caused by global climate change will negatively affect laver production and, thus, to sustain the yield of and predict future variability in laver production at the Nakdong River estuary, environmental variation around laver culturing farms needs to be monitored with high resolution in space and time.

A STUDY ON THE PREDICTION OF GROUNDWATER CONTAMINATION USING THE GIS IN HWANAM 2 SECTOR, GYEONGGI PROVINCE, KOREA (GIS를 이용한 경기도 화남2지구의 지하수오염 예측에 관한 연구)

  • HoWoongShon
    • Journal of the Korean Geophysical Society
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    • v.4 no.4
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    • pp.267-285
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    • 2001
  • This study has tried to develop the modified DRASTIC Model by supplying the parameters,such as structural lineament density and landuse, into conventional DRASTIC medal, and to predict the potential of groundwater contamination using GIS in Whanam 2 Area, Gyeonggi Province, Korea. Since the aquifers in Korea is generally through the joints of rock-mass in hydrogeological environment, lineament denisity affects to the behavior of goundwater and contaminated plumes directly, and land-use reflect the effect of point or non-point source of contamination indirectly. For the statistical analysis, lattice layers of each parameter were generated, and then level of confidence was assessed by analyzing each correlation coefficient. Composite contamination map was achieved as a final result by comparing modified DRASTIC potential and the amount of generation load of several contaminant sources logically. The result could suggest the predictability of the area of contamination potrntial in the respects of hydrogeological aspect and water quality.

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The Effects of Group Figure Therapy Programs on Psychological Exhaustion and Ego Resilience of Female Counselors (인형치료 집단프로그램이 여성 상담자들의 심리적 소진과 자아탄력성에 미치는 효과)

  • Choi, Jeong-Im
    • Journal of Convergence for Information Technology
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    • v.8 no.5
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    • pp.189-197
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    • 2018
  • The study aims to examine the availability of figure therapy in convergence perspective by verifying the effectiveness of the figure therapy programs on the psychological exhaustion and ego resilience of counselors. For the purpose, this study examine the changes of psychological exhaustion and ego resilience of participated counselors from 11 clients of general counseling center in 2 areas of Gyeonggi through the independent sample t-test and the corresponding sample t-test based on group figure therapy programs. As a result, there was a slight difference in the mean value of psychological exhaustion, and the mean of ego resilience has increased. In addition, the mean value of confidence and interpersonal efficiency, which is a sub factor of ego resilience, has increased and showed statistical significance. Based on the result, the study will be applied as a basic data of developing various figure therapy programs to improve the self resilience of counselors.

Body Sway as a Possible Indicator of Fatigue in Clerical Workers

  • Volker, Ina;Kirchner, Christine;Bock, Otmar Leo;Wascher, Edmund
    • Safety and Health at Work
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    • v.6 no.3
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    • pp.206-210
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    • 2015
  • Background: Fatigue has a strong impact on workers' performance and safety, but expedient methods for assessing fatigue on the job are not yet available. Studies discuss posturography as an indicator of fatigue, but further evidence for its use in the workplace is needed. The purpose of the study is to examine whether posturography is a suitable indicator of fatigue in clerical workers. Methods: Thirty-six employees (${\emptyset}$ 34.8 years, standard deviation = 12.5) participated in postural tasks (eyes open, eyes closed, arm swinging, and dual task) in the morning and afternoon. Position of their center of pressure (COP) was registered using a Nintendo Wii Balance Board and commercial software. From registered COP time series, we calculated the following parameters: path length (mm), velocity (mm/s), anterior-posterior variance (mm), mediolateral variance (mm), and confidence area ($mm^2$). These parameters were reduced to two orthogonal factors in a factor analysis with varimax rotation. Results: Statistical analysis of the first factor (path length and velocity) showed a significant effect of time of day: COP moved along a shorter path at a lower velocity in the afternoon compared with that in the morning. There also was a significant effect of task, but no significant interaction. Conclusion: Data suggest that postural stability of clerical workers was comparable in the morning and afternoon, but COP movement was greater in the morning. Within the framework of dynamic systems theory, this could indicate that the postural system explored the state space in more detail, and thus was more ready to respond to unexpected perturbations in the morning.

Role of the Neutrophil-to-Lymphocyte Ratio at the Time of Arrival at the Emergency Room as a Predictor of Rhabdomyolysis in Severe Trauma Patients

  • Bae, Jin Chul;Sun, Kyung Hoon;Park, Yong Jin
    • Journal of Trauma and Injury
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    • v.33 no.2
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    • pp.96-103
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    • 2020
  • Purpose: In patients with trauma, rhabdomyolysis (RM) can lead to fatal complications resulting from muscle damage. Thus, RM must be immediately diagnosed and treated to prevent complications. Creatine kinase (CK) is the most sensitive marker for diagnosing RM. However, relying on CK tests may result in delayed treatment, as it takes approximately 1 hour to obtain CK blood test results. Hence, this study investigated whether the neutrophil-to-lymphocyte ratio (NLR) could predict RM at an earlier time point in patients with trauma, since NLR results can be obtained within 10 minutes. Methods: This retrospective study included 130 patients with severe trauma who were admitted to the emergency room of a tertiary institution between January 2017 and April 2020. RM was defined as a CK level ≥1,000 U/L at the time of arrival. Patients with severe trauma were categorized into non-RM and RM groups, and their characteristics and blood test results were analyzed. Statistical analysis was performed using SPSS version 26.0 for Windows. Results: Of the 130 patients with severe trauma, 50 presented with RM. In the multivariate analysis, the NLR (odds ratio [OR], 1.252; 95% confidence interval [CI], 1.130-1.386), pH level (OR, 0.006; 95% CI, 0.000-0.198), presence of acute kidney injury (OR, 3.009; 95% CI, 1.140-7.941), and extremity Abbreviated Injury Scale score (OR, 1.819; 95% CI, 1.111-2.980) significantly differed between the non-RM and RM groups. A receiver operating characteristic analysis revealed that a cut-off NLR value of 3.64 was the best for predicting RM. Conclusions: In patients with trauma, the NLR at the time of arrival at the hospital is a useful biochemical marker for predicting RM.

Metformin Association with Lower Prostate Cancer Recurrence in Type 2 Diabetes: a Systematic Review and Meta-analysis

  • Hwang, In Cheol;Park, Sang Min;Shin, Doosup;Ahn, Hong Yup;Rieken, Malte;Shariat, Shahrokh F.
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.2
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    • pp.595-600
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    • 2015
  • Background: Accumulating evidence suggests that metformin possesses anticarcinogenic properties, and its use is associated with favorable outcomes in several cancers. However, it remains unclear whether metformin influences prognosis in prostate cancer (PCa) with concurrent type 2 diabetes (T2D). Materials and Methods: We searched PubMed, EMBASE, and the Cochrane Library from database inception to April 16, 2014 without language restrictions to identify studies investigating the effect of metformin treatment on outcomes of PCa with concurrent T2D. We conducted a meta-analysis to quantify the risk of recurrence, progression, cancer-specific mortality, and all-cause mortality. Summary relative risks (RRs) with corresponding 95% confidence intervals (CIs) were calculated. Publication bias was assessed by Begg's rank correlation test. Results: A total of eight studies fulfilled the eligibility criteria. We found that diabetic PCa patients who did not use metformin were at increased risk of cancer recurrence (RR, 1.20; 95%CI, 1.00-1.44), compared with those who used metformin. A similar trend was observed for other outcomes, but their relationships did not reach statistical significance. Funnel plot asymmetry was not observed among studies reporting recurrence (p=0.086). Conclusions: Our results suggest that metformin may improve outcomes in PCa patients with concurrent T2D. Well-designed large studies and collaborative basic research are warranted.