• Title/Summary/Keyword: 3P analysis

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Bioequivalence of Glimed Tablet to Amaryl Tablet (Glimepiride 2 mg) (아마릴 정(글리메피리드 2mg)에 대한 글리메드 정의 생물학적 동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Baek, Seung-Hee;Lee, Suk;Kim, Se-Mi;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.34 no.2
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    • pp.147-153
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    • 2004
  • The purpose of the present study was to evaluate the bioequivalence of two glimepiride tablets, $Amaryl^{\circledR}$ (Handok/Aventis Pharm. Co., Ltd.) and Glimed (Kuhn II Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The glimepiride release from the two glimepiride formulations in vitro was tested using KP VIII Apparatus II method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solution, water and blend of PSB 80 into each dissolution medium). Twenty six healthy male subjects, $22.65{\pm}2.19$ years in age and $66.55{\pm}8.85$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross-over study was employed. After one tablet containing 2 mg as glimepiride was orally administered, blood was taken at predetermined time intervals and the concentrations of glimepiride in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, 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 Amaryl were -3.70, -8.28 and 0.61% 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., $log(0.84){\sim}log(1.04)$ for $log(0.82){\sim}log(1.03)$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Glimed tablet and Amaryl tablet were bioequivalent.

Vegetation Model for Naturalness Restoration as an Ecological Renovation in a Golf Course (골프장의 생태적 리노베이션 방안으로서 식재모델 제안)

  • Lee, Hyun-Jung;Kang, Hyun-Kyung
    • Journal of the Korean Society of Environmental Restoration Technology
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    • v.7 no.2
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    • pp.75-86
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    • 2004
  • This study aims to figure out ecological characteristic of natural forests focusing on vegetation as a way of ecological renovation for the restoration of naturalness for golf courses that were constructed in the Country and to present vegetation models and appropriate tree species for the purpose. The study site is P golf club, which is located in Gapyong-gun, Kyeonggi Province. The site is within a forest where the grade from the natural ecology map is the first one and the level from the green index accounts for the eight, thus showing a typical environment for a golf course in terms of location. The location of the site explains a reason for restoration. The major substance of the study is to conduct ecological evaluation of vegetation structures around and inside the golf course and to present a vegetation model. In order to evaluate the ecological characteristics of the vegetation structures, the analysis of the study covered succession stages, multi-layer vegetation structures and species diversity. Plant communities that have high species diversity were selected for the vegetation model and proper density and species were proposed considering the number of species and individuals and distances between trees. The vegetation restoration model targets succession into an oak forest. Within a unit of 100 $m^2$, the recommended model include a tall-tree layer with 11 trees such as Quercus serrata and Quercus mongolica, a sub-tall-tree layer with 12 trees including Quercus mongolica, Quercus serrata, Prunus sargentii, Fraxinus rhynchophylla and Acer pseudo sieboldianum, a shrub layer with 32 trees from 16 species, and a grass layer with a cover rate of 45 %. The proposed vegetation restoration model needs to apply to : 1) damaged natural forests by the construction of golf courses; 2) boundaries between golf courses and surrounding forests; 3) buffer zones; 4) open spaces in between courses; and 5) areas between greens and tees where open spaces are available in a mass. In conclusion, one of the most important factors in presenting a vegetation model for the restoration of naturalness in the golf course and other damaged forests is to provide multi-layer vegetation structures that are composed of native species. As for the specific application for the site, it is recommended to manage the vegetation in such a way that the environment of the site can have a similar environment to the surrounding forest which is expected to succeed into an oaks-dominant one.

Nuclear Transfer using Human CD59 and IL-18BP Double Transgenic Fetal Fibroblasts in Miniature Pigs

  • Ryu, Junghyun;Kim, Minjeong;Ahn, Jin Seop;Ahn, Kwang Sung;Shim, Hosup
    • Journal of Embryo Transfer
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    • v.31 no.1
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    • pp.1-7
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    • 2016
  • Xenotransplantation involves multiple steps of immune rejection. The present study was designed to produce nuclear transfer embryos, prior to the production of transgenic pigs, using fibroblasts carrying transgenes human complement regulatory protein hCD59 and interleukin-18 binding protein (hIL-18BP) to reduce hyperacute rejection (HAR) and cellular rejection in pig-to-human xenotransplantation. In addition to the hCD59-mediated reduction of HAR, hIL-18BP may prevent cellular rejection by inhibiting the activation of natural killer cells, activated T-cell proliferation, and induction of $IFN-{\gamma}$. Transgene construct including hCD59 and ILI-18BP was introduced into miniature pig fetal fibroblasts. After antibiotic selection of double transgenic fibroblasts, integration of the transgene was screened by PCR, and the transgene expression was confirmed by RT-PCR. Treatment of human serum did not affect the survival of double-transgenic fibroblasts, whereas the treatment significantly reduced the survival of non-transgenic fibroblasts (p<0.01), suggesting alleviation of HAR. Among 337 reconstituted oocytes produced by nuclear transfer using the double transgenic fibroblasts, 28 (15.3%) developed to the blastocyst stage. Analysis of individual embryos indicated that 53.6% (15/28) of embryos contained the transgene. The result of the present study demonstrates the resistance of hCD59 and IL-18BP double-transgenic fibroblasts against HAR, and the usefulness of the transgenic approach may be predicted by RT-PCR and cytolytic assessment prior to actual production of transgenic pigs. Further study on the transfer of these embryos to surrogates may produce transgenic clone miniature pigs expressing hCD59 and hIL-18BP for xenotransplantation.

A Comparison between Asia-Pacific Region Criteria and Entropy Model Criteria about Body Mass Index of Elderly Females Using Morbidity of Chronic Disease (만성질환 이환율을 이용한 여자노인의 체질량지수에 대한 아시아-태평양지역 기준과 Entropy모델 기준 비교)

  • Jeong, Gu-Beom;Park, Jin-Yong;Kwon, Se-Young;Park, Kyung-Ok;Park, Pil-Sook;Park, Mi-Yeon
    • Korean Journal of Community Nutrition
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    • v.19 no.5
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    • pp.490-498
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    • 2014
  • Objectives: This study was conducted to propose the need of re-establishing the criteria of the body weight classification in the elderly. We compared the Asia-Pacific Region Criteria (APR-C) with Entropy Model Criteria (ENT-C) using Morbidity rate of chronic diseases which correlates significantly with Body Mass Index (BMI). Methods: Subjects were 886 elderly female participating in the 2007-2009 Korea National Health and Nutrition Examination Survey (KNHANES). We compared APR-C with those of ENT-C using Receiver Operating Characteristics (ROC) curve and logistic regression analysis. Results: In the case of the morbidity of hypertension, the results were as follows: Where it was in the T-off point of APR-C, sensitivity was 67.5%, specificity was 43.1%, and Youden's index was 10.6. While in the cut-off point of ENT-C, it was 56.7%, 56.6%, and 13.3 respectively. In the case of the morbidity of diabetes, the results were as follows: In the cut-off point of APR-C, Youden's index was 14.2. While in the cut-off point of ENT-C, it was 17.2 respectively. The Area Under the ROC Curve (AUC) of the subjects who had more than 2 diseases among hypertension, diabetes, and dyslipidemia was 0.615 (95% CI: 0.578-0.652). Compared to the normal group, the odds ratio of the hypertension group which will belong to the overweight or obesity was 1.79 (95% CI: 1.30-2.47) in the APR-C, and 2.04 (95% CI: 1.49-2.80) in the ENT-C (p < 0.001). Conclusions: We conclude that the optimal cut-off point of BMI to distinguish between normal weight and overweight was $24kg/m^2$ (ENT-C) rather than $23kg/m^2$ (APR-C).

Factors Influencing Posttraumatic Growth of North Korean Defectors in South Korea (북한이탈주민의 외상 후 성장에 영향을 미치는 요인)

  • Kim, Yun Ah;Kim, MiYoung
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.5
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    • pp.332-338
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    • 2016
  • This study examined the posttraumatic growth of North Korean defectors, the relation between their characteristics and posttraumatic growth and the factors influencing their posttraumatic growth, and explored methods of improving their mental health status. 145 North Korean defectors, who were trained in B city and G city, participated in the survey from February 1 to March 10, 2016. The posttraumatic growth, resilience, self-esteem, deliberate rumination, and impact of the (traumatic) event were measured using the PTGI (Posttraumatic Growth Inventory), RS (Rumination Scale, Resilience Scale), SES (Self-esteem Scale) and ISR (Impact of Event). The data were analyzed using the t-test, ANOVA, Pearson correlation coefficient and stepwise multiple regression. The mean scores were 29.64 for posttraumatic growth. There were significant positive correlations between posttraumatic growth and resilience and between posttraumatic growth and rumination. The influence of the independent variables on the total posttraumatic growth was examined using regression analysis. Models including the variables (resilience, positive self-esteem, and rumination) explained 54.2% of the variance for the posttraumatic growth. These findings demonstrate that it is essential for nurses to continuously intervene and help North Korean defectors so as to promote their posttraumatic growth and resilience. Furthermore, it is also necessary for nurses to find ways to develop ideal interventions in order to activate deliberate rumination.

A Study on the Safety Estimation of Wiring Connection Connector Manufactured by Housing Type (하우징 형태(Housing Type)로 제작된 배선 연결 커넥터의 안전성 평가에 관한 연구)

  • Choi, Chung-Seog
    • The Transactions of the Korean Institute of Electrical Engineers P
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    • v.59 no.4
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    • pp.462-466
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    • 2010
  • The purpose of this study is to evaluate the safety of a wire connector fabricated for the effective installation of a lighting fixture including its contact resistance, insulation resistance, withstanding voltage characteristics, etc., and to provide the basis for the analysis and judgment of PL(Product Liability) dispute by presenting a damage pattern due to a general flame and overcurrent. This study applied the Korean Standard (KS) for the incombustibility test of the connector using a general flame and performed an overcurrent characteristics test of the connector using PCITS (Primary Current Injection Test System). The contact resistance of the housing connector was measured using a high resistance meter and the insulation resistance was measured using a multimeter. In addition, a supply voltage of AC 1,500V for testing the withstanding voltage characteristics was applied to both ends of the connector. Measurement was performed on 5 specimens and the measured values were used as a basis for judgment. Since the connector is fabricated in the form of a housing, it can be connected and separated easily and has a structure that allows no foreign material to enter. In addition, since it has a structure that allows wires to be connected only when their polarity is identical, any misconnection that may occur during installation can be prevented. When the incombustibility test was performed by applying a general flame to the connector, it showed outstanding incombustibility characteristics and the blade and blade holder connected to the housing remained firmly secured even after the insulation sheath (PVC) was completely destroyed by fire. In addition, the mechanism of the damaged connecting wire showed a comparatively uniform carbonization pattern and it was found that some residual melted insulation material was attached to both ends. In the accelerated life test (ALT) to which approximately 500% of the rated current was applied, the connector damage proceeded in the order of white smoke generation, wire separation, spark occurrence and carbonization. That is, it could be seen that the connector damaged by overcurrent lost its own metallic color with traces of discoloration and carbonization. The contact resistance of the connector at a normal state was 2.164mV/A on average. The contact resistance measured after the high temperature test was 3.258mV/A. In addition, the insulation resistance after the temperature test was completed was greater than $10G\Omega$ and the withstanding voltage test result showed that no insulation breakdown occurred to all specimens showing stable withstanding voltage and insulation resistance characteristics.

Soil Environmental Investigation of Plastic Film House in Chonnam Area (전남지역 시설재배 토양환경 실태조사)

  • Kim, Hee-Kwon;Park, In-Jin;Kim, Joung-Keun;Kim, Sang-Chul
    • Korean Journal of Soil Science and Fertilizer
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    • v.33 no.1
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    • pp.40-46
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    • 2000
  • The investigation and the analysis of soil chemical properties, microbial flora and cultural practices in plastic house of 60 farms (pepper 20, cucumber 20, oriental melon 20) were conducted in Chonnam area film. An amount of fertilizer application of farms was more than that of standard fertilizer application. That was phosphate at two and a half times, potassium at twice and manure at three times the amount of standard application. It was inferred that excessive fertilizer application would lead to salts accumulation in soil. Continuous cropping injury would be incurred by excesive salts accumulation in soil. Even if inorganic elements in soil culturing peppers, cucumbers and oriental melons were greater than optimum level, base-saturation degree of soil culturing peppers, cucumbers and oriental melons was 40:18:12, 55:16:14 and 40:27:11 respectively. That was lower than the optimum levels (60:15:5). Therefore, crops would be affected by uptake inhibition by nutrition imbalance. Density of Fusarium is related to plant decease in soil i.e. pepper $26.2{\times}10^2\;cfu\;g^{-1}$, cucumber $75.8{\times}10^2\;cfu\;g^{-1}$ and oriental melon $6.5{\times}10^2\;cfu\;g^{-1}$. B/F of soil planted with pepper, cucumber and oriental melon was 91.2, 80.4 and 18.8, respectively.

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Formation of MOCVD TiN from a New Precursor (새로운 증착원으로 형성된 MOCVD TiN에 관한 연구)

  • Choe, Jeong-Hwan;Lee, Jae-Gap;Kim, Ji-Yong;Lee, Eun-Gu;Hong, Hae-Nam;Sin, Hyeon-Guk
    • Korean Journal of Materials Research
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    • v.9 no.3
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    • pp.244-250
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    • 1999
  • MOCVD TiN films were prepared from a new TiN precursor, tetrakis(etylmethylamino)titanium (TEMAT) and ammonia. Deposition of TiN films from a single precursor, TEMA T yielded the growth rates of $70 to 1050\AA$/min, depending on the deposition temperature. Furthermore, the excellent bottom coverage of -90% over $0.35\mu\textrm{m}$ contacts was obtained at $275^{\circ}C$. The addition of ammonia to TEMA T lowered the resistivity of as- deposited TiN film to ~ $800\mu\omega-cm$ from $3500~6000\mu\omega-cm$ and improved the stability of TiN film in air. Examination of the films by Auger electron spectroscopy(AES) showed that the oxygen and carbon contents decreased with the addition of ammonia. However, increasing ammonia flow rate decreased the bottom coverage of TiN films over $0.5\mu\textrm{m}$ contacts, probably due to the high sticking coefficient of intermediate species produced from the gas phase reaction of TEMA T and ammonia. Based on the byproduct gases detected by the quadrupole mass spectrometer (QMS), the transammination reaction was proposed to be responsible for TiN deposition. In addition, XPS analysis revealed that the carbon in the films made from TEMA T and ammonia was metallic carbon, suggesting that $\beta$-hydrogen activation process occurs competitively with the transammination reaction.

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Immunoblot analysis for serum antibodies to Pneumocystis carinii by age and intensity of infection in rats (흰쥐의 연령과 감염과정에 따른 폐포자충에 대한 항체형성 양상)

  • 홍성태;이미정
    • Parasites, Hosts and Diseases
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    • v.33 no.3
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    • pp.187-194
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    • 1995
  • The present study aims to observe changing patterns of serum antibody to hleumuvstis calinii in normal rats of different ages and in immunosuppressed rats. The serum IgG antibody was observed by immunoblotting with crude antigen of f carinii which were purified from the lungs of infected rats. The crude antigens separated in SDS-PAGE resolved more than 20 protein bands from 20 to 200 kDa. Of them,40-45, 50-55, 116 and 200 kDa bands were major antigens of R cori.nii. Most of the normal rats of up to 4 weeks had the antibodies reacting the 4 bands, but none of 8-week-old rats revealed the specific antibody. After the rats grew for 40 weeks, all were found to have the antibody in their serum. Same pattern of serum antibody level by age was found in ELISA. When immunosuppressed rats became heavily infected, the antibody in their serum decreased distinctively. The present results suggest that antibodies in normal newborn rats are transferred from their mother and lowered up to 8 weeks. Thereafter, the levels of the antibodies begin to increase by natural exposure to R cnrinii. It was also confirmed that the intensity of P cnrinii infection is inversely related with levels of serum antibodies.

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Clinical Analysis of the Prognosis of the Patients with Cerebral Diffuse Axonal Injuries, Based on Gradient-echo MR Imaging (경사에코자기공명영상을 이용한 뇌미만성 축삭 손상 환자의 예후 분석)

  • Kim, Hyoung Jong;Park, In Sung;Kim, Jae Hyoung;Kim, Ki Jeong;Hwang, Soo Hyun;Kim, Eun-Sang;Jung, Jin-Myung;Han, Jong Woo
    • Journal of Korean Neurosurgical Society
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    • v.30 no.2
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    • pp.168-172
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    • 2001
  • Objective : The authors have studied the clinical outcome of patients with diffuse axonal injuries(DAI) to evaluate the prognostic value of gradient-echo MR imaging findings. Materials and Methods : From March 1995 to March 1998, there were nineteen patients with DAI whose initial Glasgow coma scales were eight or less. Authors divided them into two groups according to Glasgow outcome scales ; those patients with GOS 3 or less(group A ; 9) and those with 4 or more(group B ; 10). We subdivided the lesions as superficial and deep lesion, and analyzed the numbers, anatomical loci of the lesions on the gradient echo images of each group. Results : Mean numbers of the lesions were 15 per case in group A(135/9) and 10 in group B(100/10). The common loci involved in DAI were cerebral cortex, brain stem, and corpus callosum. Cortical lesions were 31.1% in group A(42/135) and 47% in group B(47/100). Brain stem lesions were 25.9%(35/135) and 15%(15/100) each. Callosal lesions were 31.1%(26/135) and 13%(13/100) each. The frequency of callosal and brain stem lesions was significantly different between two groups(p<0.05). We divided callosal lesions as genu, body, and splenium and body lesions as anterior, middle, posterior, but no significant topographical difference of lesions was observed between two groups. Deep lesions were observed more frequently in group A(58.5%, 79/135) than group B(36%, 36/100). Conclusion : The poor outcome group showed more numbers of lesion and more frequent involvement of brain stem and corpus callosum than favorable outcome group. Gradient-echo MR imaging seems to have predictive value for clinical outcome in patients with DAI.

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