• Title/Summary/Keyword: Body Acceptance

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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.

Meat quality characteristics of pork bellies in relation to fat level

  • Hoa, Van-Ba;Seol, Kuk-Hwan;Seo, Hyun-Woo;Seong, Pil-Nam;Kang, Sun-Moon;Kim, Yun-Seok;Moon, Sung-Sil;Kim, Jin-Hyoung;Cho, Soo-Hyun
    • Animal Bioscience
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    • v.34 no.10
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    • pp.1663-1673
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    • 2021
  • Objective: Pork belly is considered as the most commercially important and preferable primal cut by consumers worldwide. Thus, this study was conducted to determine the effects of fat levels on the meat quality characteristics of pork bellies. Methods: Seventy-eight growing-finishing pigs collected from different commercial pig farms were slaughtered and used in the present study. After slaughter 24 h, bellies were fabricated according to the Korean Pork Cutting Specification, and immediately sampled for analysis of their fat content. Based on the fat levels, the bellies were segregated into three different groups: low fat (LF, fat ≤20%, n = 15), medium fat (MF, fat 21% to 30%, n = 30), and high fat (HF, fat ≥31%, n = 33). The bellies were then analyzed for meat quality traits, fatty acids, flavor compounds and eating quality properties. Results: The HF group had lower moisture and cooking loss levels compared to the other groups (p<0.05). The LF group presented higher proportions of polyunsaturated fatty acids compared to the other groups (p<0.05). The LF group showed higher amounts of the Maillard reaction-derived flavor compounds (e.g., 2,5-dimethyl pyrazine, 2-ethyl-3,5-dimethyl, and 4-methylthiazole) associated with meaty and roasty flavors whereas, the HF group showed higher amounts of oleic acid- derived compounds (e.g., nonanal and octanal) associated with the fatty and oily flavors. Interestingly, significantly higher scores for all the eating quality attributes (flavor, juiciness, tenderness, and overall acceptance) were found in the HF group compared to those in the LF or MF group (p<0.05). Conclusion: The high-fat bellies (fat ≥31%) had a better technological quality and eating quality compared to the low-fat bellies (fat ≤20%). Thus, increasing the fat content may improve the technological quality and eating quality traits of pork bellies, however, this increase may also result in more trimmed loss due to excessively deposited body fat.

Development of Brain Tumor Detection using Improved Clustering Method on MRI-compatible Robotic Assisted Surgery (MRI 영상 유도 수술 로봇을 위한 개선된 군집 분석 방법을 이용한 뇌종양 영역 검출 개발)

  • Kim, DaeGwan;Cha, KyoungRae;Seung, SungMin;Jeong, Semi;Choi, JongKyun;Roh, JiHyoung;Park, ChungHwan;Song, Tae-Ha
    • Journal of Biomedical Engineering Research
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    • v.40 no.3
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    • pp.105-115
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    • 2019
  • Brain tumor surgery may be difficult, but it is also incredibly important. The technological improvements for traditional brain tumor surgeries have always been a focus to improve the precision of surgery and release the potential of the technology in this important area of the body. The need for precision during brain tumor surgery has led to an increase in Robotic-assisted surgeries (RAS). One of the challenges to the widespread acceptance of RAS in the neurosurgery is to recognize invisible tumor accurately. Therefore, it is important to detect brain tumor size and location because surgeon tries to remove as much tumor as possible. In this paper, we proposed brain tumor detection procedures for MRI (Magnetic Resonance Imaging) system. A method of automatic brain tumor detection is needed to accurately target the location of the lesion during brain tumor surgery and to report the location and size of the lesion. In the qualitative assessment, the proposed method showed better results than those obtained with other brain tumor detection methods. Comparisons among all assessment criteria indicated that the proposed method was significantly superior to the threshold method with respect to all assessment criteria. The proposed method was effective for detecting brain tumor.

Effectiveness Evaluation of Displacement Accommodatable Pressure Measuring Jig for Quality Assessment of Pressure Application Device (압력 인가 장치의 품질관리를 위한 변위 수용이 가능한 압력 측정용 지그의 유효성 평가)

  • Mun, Chang-Su;Jun, Sung-Chul;Noh, Si-Cheol
    • Journal of the Institute of Convergence Signal Processing
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    • v.21 no.2
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    • pp.61-66
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    • 2020
  • Recently, a variety of electric anesthetics devices have been developed and used in clinical practice to reduce the fatigue of the operator during local anesthesia for dental procedures and to compensate for the disadvantages of manual anesthesia device. In this electric anesthesia injection device, the accurate and constant delivery of pressure for drug infusion is a very important performance factor. In order to evaluate the accuracy of the transfer pressure, a small pressure gauge using a load cell is often used, but since the elastic body inside the load cell may not be able to accommodate a sufficient displacement, an error may occur when evaluating pressure performance. For these reasons, in this study, we proposed and evaluated a silicon-chrome steel (Si-Cr steel) spring jig that can accommodate relatively large displacements that can be used when evaluating the performance of a pressure-controlled pressure application device using a load cell type pressure gauge. As a result of the pressure transmissibility test and repeated measurement results using a commercial dental anesthesia injection device, a more stable result was obtained when using a spring jig, and it was confirmed that the frequency of abnormally high measurement was reduced.

Comparison of Health-related Quality of Life Influencing Factors between Metabolic Syndrome and Osteoporotic Metabolic Syndrome in Korean Elderly People (대사증후군 노인과 골다공증을 동반한 대사증후군 노인의 건강관련 삶의 질 영향 요인 비교)

  • Kim, Eun-Sook
    • Journal of Convergence for Information Technology
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    • v.11 no.3
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    • pp.54-67
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    • 2021
  • This study is a secondary data study that analyzes the factors affecting the quality of life of the elderly with metabolic syndrome and the elderly with metabolic syndrome with osteoporosis using data from the 7th year of the National Health and Nutrition Survey (2018). The subjects of this study were 639 patients with metabolic syndrome and 161 patients with metabolic syndrome with osteoporosis. For data analysis, the composite sample Rao-Scott χ2 test, general linear model t-test, and regression model were used. As a result of the study, the factors that lowered the quality of life of metabolic syndrome were age, cohabitation, strength training, subjective health status, activity restriction, body mass index and depression, and the explanatory power was 50.4% (F=515.96, p<.001). In metabolic syndrome with osteoporosis, age, subjective health status, activity restriction, and stress were the factors that lowered the quality of life, and the explanatory power was 48.6% (F=10.42, p<.001). Based on these results, it is necessary to develop and provide an intensive multidisciplinary program for the elderly with metabolic syndrome accompanied by osteoporosis to solve the problem of activity restrictions and manage stress reduction through positive acceptance of health status, instrumental and social support, and caring support.

A Study on Wearable Augmented Reality-Based Experiential Content: Focusing on AR Stone Tower Content (착용형 증강현실 기반 체험형 콘텐츠 연구: AR 돌탑 콘텐츠를 중심으로)

  • Inyoung Choi;Hieyong Jeong;Choonsung Shin
    • Smart Media Journal
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    • v.13 no.4
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    • pp.114-123
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    • 2024
  • This paper proposes AR stone tower content, an experiential content based on wearable augmented reality (AR). Although wearable augmented reality is gaining attention, the acceptance of the technology is still focused on specialized applications such as industrial sites. On the other hand, the proposed AR stone tower content is based on the material of 'stone tower' so that general users can relate to it and easily participate in it, and it is organized to utilize space in a moving environment and find and stack stones based on natural hand gestures. The proposed AR stone tower content was implemented in the HoloLens 2 environment and evaluated by general users through a pilot exhibition in a small art museum. The evaluation results showed that the overall satisfaction with the content averaged 3.85, and the content appropriateness for the stone tower material was very high at 4.15. In particular, users were highly satisfied with content comprehension and sound, but somewhat less satisfied with object recognition, body adaptation, and object control. The above user evaluations confirm the resonance and positive response to the material, but also highlight the difficulties of the average user in experiencing and interacting with the wearable AR environment.

A Study on the Power Supply and Demand Policy to Minimize Social Cost in Competitive Market (경쟁시장 하에서 사회적 비용을 고려한 전력수급정책 방향에 관한 연구)

  • Kwon, Byung-Hun;Song, Byung Gun;Kang, Seung-Jin
    • Environmental and Resource Economics Review
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    • v.14 no.4
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    • pp.817-838
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    • 2005
  • In this paper, the resource adequacy as well as the optimum fuel mix is obtained by the following procedures. First, the regulation body, the government agency, determine the reliability index as well as the optimum portfolio of the fuel mix during the planning horizon. Here, the resources with the characteristics of public goods such as demand-side management, renewable resources are assigned in advance. Also, the optimum portfolio is determined by reflecting the economics, environmental characteristics, public acceptance, regional supply and demand, etc. Second, the government announces the required amount of each fuel-type new resources during the planning horizon and the market participants bid to the government based on their own estimated fixed cost. Here, the government announces the winners of the each auction by plant type and the guaranteed fixed cost is determined by the marginal auction price by plant type. Third, the energy market is run and the surplus of each plant except their cost (guaranteed fixed cost and operating cost) is withdrew by the regulatory body. Here, to induce the generators to reduce their operating cost some incentives for each generator is given based on their performance. The performance is determined by the mechanism of the performance-based regulation (PBR). Here the free-riding performance should be subtracted to guarantee the transparent competition. Although the suggested mechanism looks like very regulated one, it provides two mechanism of the competition. That is, one is in the resource construction auction and the other is in the energy spot market. Also the advantages of the proposed method are it guarantee the proper resource adequacy as well as the desired fuel mix. However, this mechanism should be sustained during the transient period of the deregulation only. Therefore, generation resource planning procedure and market mechanisms are suggested to minimize possible stranded costs.

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The Death Orientation of nursing students in Korea and China (한국과 중국 간호대학생의 죽음에 대한 의식)

  • Li, Zhen-Shu;Choe, Wha-Sook
    • Korean Journal of Hospice Care
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    • v.8 no.1
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    • pp.1-12
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    • 2008
  • Perpose: The purpose of this study was to investigate the perception of death between Korean and Chinese nursing students. And it will help develop curriculum for preparing death, the quality of hospice care, as well as nursing education and practice. Methods: Data was collected from 492 nursing students participated(248 Korean and 244 Chinese) by questionnaire designed for examining Death Orientation (Thorson & Powell, 1988). They were analyzed using Cronbach's Alpha coefficients, factor analysis, t-test, ANOVA and regression analysis (SPSS; win 12.0 version) Results: More than half of the Korean nursing students followed a religion (58.5%) while the majority of Chinese nursing students did not follow a religion (93.9%). In the view of the afterlife, nursing students in China had two views. 'I really don't know what happens after a person dies (30.3%)' and ‘There is no afterlife and death is the end (29.5%)’. On the other hand the Korean nursing students’ answer were, 'After dying, a person goes to heaven or hell (27.3%)' and 'I really don't know what happens after a person dies. (22.9%)' The study also found that the average of 25 items in Death Orientation is 2.36points of nursing students in Korea and 2.50points of nursing students in China. This means that the concern, anxiety and fear were of the middle level for the Chinese Students and were higher than Korean students (t=3.51, p=.000). In the low factor of death orientation, those in Korea had higher 'anxiety of burden to family' than those in China (t=-3.50, p=.001). The nursing students in China had higher 'anxiety of the unknown (t=4.96, p=.000)', 'fear of suffering (t=6.88, p=.000), 'fear of extinction body and life (t=5.20, p=.000), 'fear of lost self-control(t=2.12, p=.034)', and 'anxiety of future existence and nonexistence (t=2.33, p=.020)' than those in Korea. There was no statistically significant difference for the 'concern of body and fear of identity lost' category. The death orientation of Korean nursing students had statistically significant differences according to age (t=3.20, p=.002), religion (t=2.56, p=.011), and afterlife (F=4.64, p=.000). The contribution of Death Orientation had a statistically significant difference, the afterlife variable (0.735, p=0.001). The death orientation of Chinese nursing students did not have any statistically significant differences. Conclusion: In conclusion, there were differences in death orientation between Korean and Chinese nursing students. In particular, those who believed in afterlife showed acceptance of death. The results of this study suggest that nursing curricula should include education program on death and spiritual nursing. Additional studies are needed to establish death education in China with careful considerations on Chinese policies, cultures and social systems.

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Bioequivalence of Burophil Capsule to Surfolase Capsule (Acebrophylline 100 mg) (설포라제 캡슐(아세브로필린 100 mg)에 대한 부로필 캡슐의 생물학적 동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Kim, Se-Mi;Park, Chan-Ho;Oh, In-Joon;Lim, Dong-Koo;Lee, Myung-Hee;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.3
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    • pp.179-185
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    • 2005
  • Acebrophylline is a compound produced by salifying ambroxol with theophylline-7 -acetic acid. After acebrophylline administration, the salt splits into these two components which feature a peculiar pharmacokinetic behavior, an adequate ambroxol and a low theophylline-7-acetic acid serum levels. The purpose of the present study was to evaluate the bioequivalence of two acebrophylline capsules, Surfolase (Hyundai Pharm. lnd. Co., Ltd.) and Burophil (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of ambroxol from the two acebrophylline 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 eight healthy male subjects, $23.25{\pm}1.43$ years in age and $64.82{\pm}6.77$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two capsules containing 100 mg as acebrophylline were orally administered, blood was taken at predetermined time intervals and the concentrations of ambroxol in serum were determined using HPLC with electrochemical detector (ECD). 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 Surfolase, were -1.64, -3.33 and -0.92% 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 $(e.g., \;log\;0.93{\sim}log\;1.05\;and\;log\;0.88{\sim}log\;1.05$ for $AUC_t$, and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Burophil capsule was bioequivalent to Surfolase capsule.