• Title/Summary/Keyword: statistical data analysis

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Bioequivalence Test of Gabapentin 400 mg Capsules (가바펜틴 400밀리그람 캡슐의 생물학적동등성시험)

  • Kim, Se-Mi;Kang, Hyun-Ah;Cho, Hea-Young;Shin, Sae-Byeok;Yoo, Hee-Doo;Yoon, Hwa;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.3
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    • pp.195-200
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    • 2008
  • Gabapentin, [1-(aminomethyl) cyclohexaneacetic acid], a structural analog of $\gamma$-aminobutyric acid (GABA), is being developed for the treatment of epilepsy. Unlike GABA, gabapentin crosses the blood-brain barrier after systemic administration. Gabapentin is an effective antiepileptic drug in patients with partial and secondarily generalized seizures who are uncontrolled with use of existing anticonvulsant drug therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin 400 mg capsules, $Neurontin^{(R)}$ capsule 400 mg (Pfizer Inc.) and Gabatin capsule 400 mg (Korean Drug Co. Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, 23.58$\pm$1.50 years in age and 66.74$\pm$8.31 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After one capsule containing 400 mg as gabapentin were orally administered, blood was taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{(R)}$ capsule 400 mg, were 2.04, -3.68 and 16.79% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.91$\sim$log 1.16 and log 0.87$\sim$log 1.11 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabatin capsule 400 mg was bioequivalent to $Neurontin^{(R)}$ capsule 400 mg.

Bioequivalence Test of Fexofenadine Hydrochloride 120 mg Tablets (염산펙소페나딘 120밀리그람 정제의 생물학적동등성시험)

  • Cho, Hea-Young;Kang, Hyun-Ah;Kim, Se-Mi;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.3
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    • pp.188-194
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    • 2008
  • Fexofenadine, ($\pm$)-4-1-hydroxy-4-{4-(hydroxydiphenylmethyl)-1-piperidinyl}-butyl-a,a-dimethyl benzeneacetic acid, is a selective histamine $H_1$ receptor antagonist, and is clinically effective in the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria as a first-line therapeutic agent. The purpose of the present study was to evaluate the bioequivalence of two fexofenadine hydrochloride tablets, $Allegra^{(R)}$ (Handok Pharmaceuticals Co., Ltd.) and Alecort (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of fexofenadine from the two fexofenadine hydrochloride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media. Twenty six healthy male subjects, 25.62$\pm$3.35 years in age and 70.05$\pm$11.71 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After a single tablet containing 120 mg as fexofenadine hydrochloride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of fexofenadine in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The harmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Allegra^{(R)}$, were -1.37, 5.22 and 16.50% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.83$\sim$log 1.08 and log 0.81$\sim$log 1.03 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Alecort tablet was bioequivalent to $Allegra^{(R)}$ tablet.

Quality of Life and Economic Impact of Adult Atopic Dermatitis Patients in Seoul (서울 지역을 대상으로 모집된 성인 아토피피부염 환자의 삶의 질과 경제적 비용 부담에 관한 조사)

  • Yun, Young-Hee;Choi, In-Hwa
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.23 no.1
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    • pp.199-214
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    • 2010
  • Objective : Atopic dermatitis (AD) may profoundly affect patient's quality of life (QOL), and also cause economic impact. The aim of our study was to evaluate the quality of life and the economic impact of adult atopic dermatitis patient in Seoul. We also evaluate the relationship of QOL and economic impact with severity of AD. Methods : 30 adult atopic dermatitis patient were included and evaluated by using the SCORAD Index and EASI. Patients were asked to fill in the questionnaires about their quality of life and financial costs during the past year by AD. Data about sleep disturbance and pruritus were also obtained. Pearson's correlation were used for statistical analysis. Results : 1. Among 30 patients, women were 19(63.3%), men were 11(36.7%). The mean age of the patients were 27.3 years old, patients between the ages of 17 and 30 years were 23, over 30 were seven. 2. The mean score of Objective SCORAD was $32.89{\pm}7.30$, Subjective SCORAD was $8.13{\pm}3.53$ and EASI was $9.15{\pm}6.90$이었다. 3. The mean score of Skindex-29 was $28.26{\pm}7.58$, DLQI was $10.17{\pm}5.55$. 4. By analyzing the questionnaire, a monthly average cost of 583,200 won for each patient was determined. Direct cost was 236,800 won and indirect cost was 346,300 won. 5. By analyzing the correlation between the severity of AD and QOL, Objective SCORAD and EASI were positively correlated with QOL(Skindex-29, DLQI) but not significant, meanwhile subjective SCORAD were significantly and positively correlated with QOL(Skindex-29, DLQI). 6. By analyzing the correlation between the severity of AD and economic impact, Objective SCORAD were significantly and positively correlated with direct cost and indirect cost. Also, EASI were significantly and positively correlated with direct cost and oriental medical hospital visits. Conclusions : The above results show that the QOL of the patients with atopic dermatitis is significantly related to their disease severity. Atopic dermatitis patients pay 583,200 won a month, and the economic impact of the patients is significantly related to their disease severity.

Productivity Effect of Firms' External R&D and the Moderating Effect of Firm Size (기업 외부 연구개발투자의 생산성효과와 기업규모의 조절효과)

  • Kim, Kyung-ho;Jung, Jin Hwa
    • Journal of Korea Technology Innovation Society
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    • v.21 no.3
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    • pp.1077-1100
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    • 2018
  • The present study analyzed the effect of firms' external research and development (R&D) on corporate productivity, while investigating the moderating effect of firm size on the external R&D-productivity nexus. In the empirical analysis, we estimated South Korean manufacturing firms' total factor productivity (TFP) using the firm level data drawn from the Survey of Business Activities (Korea National Statistical Office) for the years 2006-2015. Thereafter, focusing on the role of external R&D and its interaction with the firm size in determining firms' TFP, the productivity function was estimated as well. To this end, we used ordinary least squares (OLS) and quantile regression to highlight the heterogeneous impacts of external R&D by companies' productivity level. Empirical results confirmed that firms' external R&D significantly enhanced corporate productivity in all manufacturing industries, from high-tech to low-tech. The moderating effect of firm size in determining the productivity effect of external R&D was not as prominent as in the case for internal R&D, which exhibited some degree of the size premium in the productivity-enhancing effect. These results suggest that regardless of the firm size, external R&D can be an important channel for corporate productivity improvement, and can be a particularly effective strategy for SMEs with relatively limited internal R&D capacities.

Comparison of Fornix and Stria Terminalis Connectivity among First-Episode Schizophrenia, Chronic Schizophrenia and Healthy Controls (초발 조현병, 만성 조현병과 건강 대조군의 뇌활과 분계섬유줄 연결성 비교)

  • Lee, Arira;Yun, Mirim;Yook, Ki Hwan;Choi, Tai Kiu;Lee, Kang Soo;Bang, Minji;Lee, Sang-Hyuk
    • Korean Journal of Biological Psychiatry
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    • v.26 no.1
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    • pp.8-13
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    • 2019
  • Objectives Disrupted integrities of the fornix and stria terminalis have been suggested in schizophrenia. However, very few studies have focused on the fornix and stria terminalis comparing first-episode schizophrenia (FESZ), chronic schizophrenia (CS), and healthy controls (HCs) with the application of diffusion-tensor imaging (DTI) technique. The objective of this study is to compare the connectivity of the fornix and stria terminalis among FESZ, CS, and HCs. Methods We included the 44 FESZ patients, 39 CS patients and 20 HCs in this study. Voxel-wise statistical analysis of the fractional anisotropy (FA) data was performed using Tract-Based Spatial Statistics to analyze the connectivity of fornix and stria terminalis. In addition, the Scale for the Assessment of Positive Symptoms (SAPS) and the Scale for the Assessment of Negative Symptoms (SANS) were used to evaluate clinical symptom severities. Results There were no significant differences between the FESZ, CS, and HCs in age, sex, education years. The SAPS and SANS scores of the schizophrenia groups showed no significant differences. FA values of the right fornix cres/stria terminalis in the CS group were significantly lower than those in FESZ and HCs. There were no significant differences of FA values of the right fornix cres/stria terminalis between the FESZ and the HCs. Pearson correlation analyses revealed that significant correlation between FA values of the right fornix cres/stria terminalies of the the FESZ group and positive, negative symptom scales, and FA values of the right fornix cres/stria terminalis of the CS group and negative symptom scales. Conclusions This study shows that FA values of the fornix and stria terminalis in the CS were lower than in the FESZ and the HCs. These results suggest that the fornix and stria terminalis can play a role in pathophysiology of schizophrenia. Thus current study can broaden our understanding of the pathophysiology of schizophrenia.

Analyzing the Relationship between Dynamic Capability of Project-Based Organization and the Competitive Advantage in the E&C Companies (프로젝트 조직의 동적역량과 건설기업 경쟁우위와의 상관관계 분석)

  • Jin, Sangjoon;Oh, Minjeong;Kim, Seungchul
    • Korean Journal of Construction Engineering and Management
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    • v.20 no.1
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    • pp.73-85
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    • 2019
  • Since the beginning of a new century, many Korean construction and engineering companies are facing a very dynamic and fast changing business environment which includes severe competition, higher risk, economic depression, declining revenues and profits, etc. In order to cope with these challenges, they need to secure special capabilities to actively adapt to the paradigm changes. One of those capabilities could be project management capability which allows us to manage organizational resources dynamically and integratively based on project portfolio management concept. The objective of this study is to investigate how the dynamic capability of a project-based organization to control the resource affects the firm performance and the competitive advantages. Data was collected from the construction and engineering companies in South Korea by using survey questionnaire, and analyzed for empirical tests by using statistical methods such as structural equation modelling and path analysis. The results showed that the organizational resources, if they had the VRIN characteristics, would have positive impacts on creating the dynamic capabilities for project organization. In turn, the dynamic capabilities of a project organization would have impacts on improving business performance and creating competitive advantages. Also, it was found that the organizational resources may have direct impact on business performance and competitive advantages. The academic contribution of this study is that it attempts to integrate resource based view and the dynamic capability theory about creating competitive advantages for project based organization. This study also provided practical implications to the companies in construction industry by showing how to use organizational resources strategically to create competitive advantages.

The Elderly Welfare Housing Intention and Influencing Factors of the Elderly Women: An Application of the Theory of Planned Behavior (계획된 행동이론을 통해 본 고령여성의 노인복지주택 입주의도 영향요인)

  • Shim, Eui Kyung
    • 한국노년학
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    • v.36 no.3
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    • pp.563-579
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    • 2016
  • The purpose of this study is to examine predictors of move intention to welfare housing in Korea. Participants completed a questionnaire which included measures of socioeconomic variables, variables of the theory of planned behavior. The data was collected from 380 elderly women over the age of 60 in Korea. This study was examined by statistical analysis on SPSS program 18.0. The results of this study are as follows. First, the attitude of elderly women have a positive effect on welfare housing. Second, the subjective norm of elderly women have a positive effect on welfare housing. Third, the perceived behavioral control of elderly women positively effect on welfare housing. The results of this study prove that attitudes, subjective norms, perceived behavioral control is part of the theory of planned behavior. The finding shows that modified, the theory of planned behavior can be used as a guide in predicting behavioral intention. we should be responsible for the follow-up and monitoring of situations and reevaluate periodically to ensure that needs are being met and services are appropriate. These things are very important to succeed for senior citizens in Korea.

Assessment of Carbon Stock and Uptake by Estimation of Stem Taper Equation for Pinus densiflora in Korea (우리나라 소나무의 수간곡선식 추정에 의한 탄소저장량 및 흡수량 산정)

  • Kang, Jin-Taek;Son, Yeong-Mo;Jeon, Ju-Hyeon;Lee, Sun-Jeoung
    • Journal of Climate Change Research
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    • v.8 no.4
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    • pp.415-424
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    • 2017
  • This study was conducted to estimate carbon stocks of Pinus densiflora with drawing volume of trees in each tree height and DBH applying the suitable stem taper equation and tree specific carbon emission factors, using collected growth data from all over the country. Information on distribution area, tree age, tree number per hectare, tree volume and volume stocks were obtained from the $5^{th}$ National Forest Inventory (2006~2010) and Statistical yearbook of forest (2016), and method provided in IPCC GPG was applied to estimate carbon stock and uptake. Performance in predicting stem diameter at a specific point along a stem in Pinus densiflora by applying Kozak's model, $d=a_{1}DBH^{a_2}a_3^{DBH}X^{b_{1}Z^2+b_2ln(Z+0.001)+b_3\sqrt{Z}+b_4e^z+b_5(\frac{DBH}{H})}$, which is well known equation in stem taper estimation, was evaluated with validations statistics, Fitness Index, Bias and Standard Error of Bias. Consequently, Kozak's model turned out to be suitable in all validations statistics. Stem volume table of P. densiflora was derived by applying Kozak's model and carbon stock tables in each tree height and DBH were developed with country-specific carbon emission factors ($WD=0.445t/m^3$, BEF = 1.445, R = 0.255) of P. densiflora. As the results of analysis in carbon uptake for each province, the values were high with Gangwon-do $9.4tCO_2/ha/yr$, Gyeongsandnam-do and Gyeonggi-do $8.7tCO_2/ha/yr$, Chungcheongnam-do $7.9tCO_2/ha/yr$ and Gyeongsangbuk-do $7.8tCO_2/ha/yr$ in order, and Jeju-do was the lowest with $6.8tC/ha/yr$. Total carbon stocks of P. densiflora were 127,677 thousands tC which is 25.5% compared with total percentage of forest and carbon stock per hectare (ha) was $84.5tC/ha/yr$ and $7.8tCO_2/ha/yr$, respectively.

An Empirical Analysis on the Effects of Kyoto Protocol on the Greenhouse Gas Emissions (교토의정서의 온실가스 감축 변화로 본 레짐효과 분석)

  • Kim, Yeong Sin;Chon, Chun Hwang;Baek, Hee Jeong
    • Journal of Climate Change Research
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    • v.1 no.1
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    • pp.1-11
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    • 2010
  • This study is analyzed based on the statistical data for the effect of Kyoto Protocol which is adopted on 1997. The first greenhouse gas obligation reduction countries such as OECD (Organization for Economic Cooperation and Development), and the first non-obligated developing countries such as China and India, the increasing rate of carbon dioxide emission displayed -10.2% and 88.1% in 2005 with respect to 1990, respectively. This increasing rate is not only shows statistically significant differences but also shows significant meanings when we consider the global increasing rate of carbon dioxide is 29.1%. Changes in the carbon dioxide emissions are also analyzed based on the time of the adaptation of Kyoto Protocol, time of the publication of the second and third reports of IPCC, and withdrawal of the Kyoto Protocol of the United States. Withdrawal of the Kyoto Protocol of the United States is the most significantly affected to the differences in the carbon dioxide emission rates rather than the adaptation of Kyoto Protocol, international agreement on the greenhouse gas reduction, and belief on the scientific evidence for the reasons for increasing carbon dioxide concentrations. Therefore, acceptance of the post-Kyoto Protocol in the United States is very important in order to success as a climate regime.

Grandparenting Style and Consumption Behavior of Elderly Consumers for Grandchildren (한국 노인의 조부모역할 유형과 손자녀를 위한 소비행동)

  • Hong, Seung Woo;Choi, Hye Kyong
    • 한국노년학
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    • v.32 no.4
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    • pp.1163-1180
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    • 2012
  • The main purpose of this study is to figure out the spending tendency of elderly consumers for their grandchildren. To this end, a detailed survey was carried out for two months from October 1 to November 30, 2011. The respondents consist of 461 elderly consumers over 60s who have grandchildren in elementary grades. Among the gathered data, relevant information was sorted out, coded, and then turned into statistical figures through SPSS 18.0 program. The outcome of this research is explained in the following three respects. First of all, based upon factor and cluster analysis, the role of grandparents has been divided into three categories, which are a babysitter, a friend and a visitor. Depending on their role, the surveyed elderly have been split into three groups-'Friend Group', 'Formal Visitor Group', 'Attached Group'. Second, to give you an overview of the consumption trend of the three groups, this study has reviewed the expenditure items, spending amount and consumption patterns, and made a list of products and services they purchased for the past one year for their grandchildren. Third, given the probability of wealth transfer to the next generation, there is a compelling need to figure out the purchase pattern of financial products. The elderly have been categorized into those with bank deposits only and those with a mixture of bank deposits and other financial products (insurance, fund, stocks, gold, dollar etc.).