• Title/Summary/Keyword: AE parameters

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Bioequivalence of Enteric-coated Omeprazole Products (오메프라졸 장용성제제에 대한 생물학적 동등성 평가)

  • Kim, Chong-Kook;Jeong, Eun-Ju;Lee, Eun-Jin;Shin, Hee-Jong;Lee, Won-Keun
    • Journal of Pharmaceutical Investigation
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    • v.23 no.1
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    • pp.41-49
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    • 1993
  • The bioequivalence of two omeprazole enteric-coated products was evaluated in 16 normal male volunteers (age 26-32 yr, body weight 57-75 kg) following single oral administration. Test product was enteric-coated KD-182 tablet (Chong Kun Dang Corp., Korea) and reference product was $Rosec^{\circledR}$ capsule containing enteric-coated pellets of omeprazole (Yuhan Corp., Korea). Both products contain 20 mg of omeprazole. One tablet or capsule of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study ($2\;{\times}\;2$ Latin square method). Average drug concetrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products(p>0.05); the area under the concentrationtime curve to last sampling time (8 hr) $(AUC_{0-8hr})$ $(1946.5{\pm}675.3\;vs\;2018.3{\pm}761.6\;ng{\cdot}hr/ml)$, AUC from time zero to infinite $(AUC_{o-\infty})$ $(2288.6{\pm}1212.8\;vs\;2264.9{\pm}1001.3\;ng{\cdot}hr/ml)$, maximum plasma concentration $(C_{max})$ $(772.5{\pm}283.3\;vs\;925.8{\pm}187.7\;ng/ml)$, time to maximum plasma concentration $(T_{max})$ $(2.38{\pm}1.06\;vs\;2.34{\pm}1.09\;hr)$, apparent elimination rate constant $(k_{\ell})$ $(0.5339{\pm}0.2687\;vs\;0.5769 {\pm}0.2184\;hr^{-I})$, apparent absorption rate constant $(k_a)$ $(1.1536{\pm}0.5278\;vs\;0.9739{\pm}0.9507 hr^{-1})$ and mean residence time (MRT) $(3.13{\pm}0.73\;vs \;3.41{\pm}1.04\;hr)$. The differences of mean $(AUC_{0-8hr})$, $C_{max}$, $T_{max}$ and MRT between the two products (3.69, 19.83, 1.32 and 8.99%, respectively) were less than 20%. The power $(1-{\beta})$ and treatment difference $(\triangle)$ for $AUC_{o-8hr}$ $C_{max}$ and MRT were more than 0.8 and less than 0.2, respectively. Although the power for $T_{max}$ was under 0.8, $T_{max}$ of the two products was not significantly different each other(p>0.05). These results suggest that the bioavailability of KD-182 tablet is not significantly different from that of $Rosec^{\circledR}$ capsule. Therefore, two products are bioequivalent based on the current results.

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Bioequivalence of EtodolTM Tablet to KuhnillodineTM Tablet (Micronized Etodolac 200 mg) (건일로딘 정(미결정에토돌락 200 mg)에 대한 에토돌 정의 생물학적동등성)

  • Lee, Jung-Ae;Lee, Yun-Young;Cho, Tae-Seob;Park, Young-Joon;Moon, Byoung-Seok;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.4
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    • pp.319-325
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    • 2004
  • A bioequivalence of $Etodol^{TM}$ tablets (Yuhan corporation) and $Kuhnillodine^{TM}$ tablets (Kuhnil Pharm. Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 mg dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2{\times}2$ crossover design. Concentrations of etodolac in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Etodol^{TM}/Kuhnillodine^{TM}$ were 1.01-1.10 and 0.87-1.06, respectively. This study demonstrated a bioequivalence of $Etodol^{TM}$ and $Kuhnillodine^{TM}$ with respect to the rate and extent of absorption.

Crystal Structure Analysis of $LiN(D_xH_{1-x}){_4}SO_4$ by X-ray and Neutron Diffraction (X-선과 중성자 회절을 이용한 강유전체 단결정 $LiN(D_xH_{1-x}){_4}SO_4$의 결정구조 연구)

  • Kim, Shin-Ae;Kim, Seong-Hoon;So, Ji-Yong;Lee, Jeong-Soo;Lee, Chana-Hee
    • Journal of the Mineralogical Society of Korea
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    • v.20 no.4
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    • pp.351-356
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    • 2007
  • The crystal structure of $Li(ND_4)SO_4$ was analyzed by X-ray and neutron diffraction methods. The crystal is a deuterated $Li(NH_4)SO_4$ and one of the ferroelectric materials with hydrogen atoms. The crystal is orthorhombic at room temperature, $P2_1nb$, with lattice parameters of $a=5.2773(5)\;{\AA},\;b=9.1244(23)\;{\AA},\;c=8.7719(11)\;{\AA}$ and Z=4. Neutron intensity data were collected on the Four-Circle diffractometer (FCD) at HANARO in Korea Atomic Energy Research Institute and X-ray date were given by Prof. Y. Noda of Tohoku University Japan. The structure was refined by full-matrix least-square to final R value of 0.070 for 1450 observed reflections by X-ray diffraction and to final R=0.049 for 745 observed reflections by neutron diffraction. With X-ray data we obtained only one hydrogen atomic position. However, not only all atomic positions of four hydrogen atoms at $NH_4$ but also the occupation factors of D and H were refined with neutron data. From this results we obtained the average chemical structure of this sample, $LiND_{3.05}H_{0.95}SO_4$.

Phytoplankton Community Structure of Midstream of Geum River on 2014 and 2015 (금강 중류의 식물플랑크톤 군집 동태 이해 (2014~2015))

  • Han, Sa Rang;Cho, Kichul;Yoon, Jo-Hee;Lee, Jay-Jung;Yoo, Soon-Ae;Choi, In-Chan;Joo, Hyun-Ji;Cheon, Se-Uk;Lim, Byung-Jin
    • Korean Journal of Ecology and Environment
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    • v.49 no.4
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    • pp.375-384
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    • 2016
  • Phytoplankton community is one of the important factors for the management of aquatic environment due to generation of varying toxins by harmful algal species. This study was performed to examine the phytoplankton community structure (PCS) in the midstream of Geum River (GR) from January 2014 to December 2015. The water sampling was performed in five stations on 2014, and three stations on 2015. Subsequently, the morphological identification was performed by microscopic observation in laboratory condition. As results, total 265 species were identified and it was comprised of 40.8% of Bacillariophyceae, 9.1% of Cyanophyceae, 44.5% of Chlorophyceae, and the others (4.9%). During the investigation period, total average standing crop of phytoplankton was $12,948cells\;mL^{-1}$, and it was comprised of $7,702cells\;mL^{-1}$ of Bacillariophyceae, $2,821cells\;mL^{-1}$ of Cyanophyceae, $2,121cells\;mL^{-1}$ of Chlorophyceae, and $305cells\;mL^{-1}$ of others. To verify which tributaries of upstream area influence on PCS of midstream of GR, the phytoplankton standing crops of two stations including Mihocheon (MH) and Gapcheon (GC) were examined on 2014, and compared to result of on 2015. The results were shown that the MH station had more similar phytoplankton standing crops with midstream of GR than GC station. The relationship between environmental parameters and phytoplankton dynamics was studied at the investigated station. As results, whereas water temperature and total phosphorus were represented the positive correlation, N/P ratio was remarkably exhibited negative correlation. From the results, it is suggested that the PCS of midstream of GR was more affected by MH station than GC station, and the changes of temperature, phosphorus concentration, and N/P ratio may be important factors on the PCS formation of midstream of GR.

Simulation of TOA Visible Radiance for the Ocean Target and its Possible use for Satellite Sensor Calibration (해양 표적을 이용한 대기 상단 가시영역에서의 복사휘도 모의와 위성 센서 검보정에의 활용 가능성 연구)

  • Kim, Jung-Gun;Sohn, Byung-Ju;Chung, Eui-Seok;Chun, Hyoung-Wook;Suh, Ae-Sook;Kim, Kum-Lan;Oh, Mi-Lim
    • Korean Journal of Remote Sensing
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    • v.24 no.6
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    • pp.535-549
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    • 2008
  • Vicarious calibration for the satellite sensor relies on simulated TOA (Top-of-Atmosphere) radiances over various targets. In this study, TOA visible radiance was calculated over ocean targets which are located in five different regions over the Indian and Pacific ocean, and its possible use for the satellite sensor calibration was examined. TOA radiances are simulated with the 6S radiative transfer model for the comparison with MODIS/Terra and SeaWiFS measurements. Geometric angles and sensor characteristics of the reference satellites were taken into account for the simulation. AOT (Aerosol Optical Thickness) from MODIS/Terra, pigment concentrations from Sea WiFS, and ozone amount from OMI measurements were used as inputs to the model. Other atmospheric input parameters such as surface wind and total column water vapor were taken from NCEP/NCAR reanalysis data. The 5-day averaged radiances over all targets show that the percent differences between simulated and observed radiances are within about ${\pm}5%$ in year 2005, indicating that the calculated radiances are in good agreement with satellite measurements. It has also been shown that the algorithm can produce the SeaWiFS radiances within about ${\pm}5%$ uncertainty range. It has been suggested that the algorithm can be used as a tool for calibrating the VIS bands within about 5% uncertainty range.

ChIP-seq Library Preparation and NGS Data Analysis Using the Galaxy Platform (ChIP-seq 라이브러리 제작 및 Galaxy 플랫폼을 이용한 NGS 데이터 분석)

  • Kang, Yujin;Kang, Jin;Kim, Yea Woon;Kim, AeRi
    • Journal of Life Science
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    • v.31 no.4
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    • pp.410-417
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    • 2021
  • Next-generation sequencing (NGS) is a high-throughput technique for sequencing large numbers of DNA fragments that are prepared from a genome. This sequencing technique has been used to elucidate whole genome sequences of living organisms and to analyze complementary DNA (cDNA) or chromatin immunoprecipitated DNA (ChIPed DNA) at the genome level. After NGS, the use of proper tools is important for processing and analyzing data with reasonable parameters. However, handling large-scale sequencing data and programing for data analysis can be difficult. The Galaxy platform, a public web service system, provides many different tools for NGS data analysis, and it allows researchers to analyze their data on a web browser with no deep knowledge about bioinformatics and/or programing. In this study, we explain the procedure for preparing chromatin immunoprecipitation-sequencing (ChIP-seq) libraries and steps for analyzing ChIP-seq data using the Galaxy platform. The data analysis steps include the NGS data upload to Galaxy, quality check of the NGS data, premapping processes, read mapping, the post-mapping process, peak-calling and visualization by window view, heatmaps, average profile, and correlation analysis. Analysis of our histone H3K4me1 ChIP-seq data in K562 cells shows that it correlates with public data. Thus, NGS data analysis using the Galaxy platform can provide an easy approach to bioinformatics.

Comparison of Mesoscale Eddy Detection from Satellite Altimeter Data and Ocean Color Data in the East Sea (인공위성 고도계 자료와 해색 위성 자료 기반의 동해 중규모 소용돌이 탐지 비교)

  • PARK, JI-EUN;PARK, KYUNG-AE
    • The Sea:JOURNAL OF THE KOREAN SOCIETY OF OCEANOGRAPHY
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    • v.24 no.2
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    • pp.282-297
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    • 2019
  • Detection of mesoscale oceanic eddies using satellite data can utilize various ocean parameters such as sea surface temperature (SST), chlorophyll-a pigment concentration in phytoplankton, and sea level altimetry measurements. Observation methods vary for each satellite dataset, as it is obtained using different temporal and spatial resolution, and optimized data processing. Different detection results can be derived for the same oceanic eddies; therefore, fundamental research on eddy detection using satellite data is required. In this study, we used ocean color satellite data, sea level altimetry data, and infrared SST data to detect mesoscale eddies in the East Sea and compared results from different detection methods. The sea surface current field derived from the consecutive ocean color chlorophyll-a concentration images using the maximum cross correlation coefficient and the geostrophic current field obtained from the sea level altimetry data were used to detect the mesoscale eddies in the East Sea. In order to compare the eddy detection from satellite data, the results were divided into three cases as follows: 1) the eddy was detected in both the ocean color and altimeter images simultaneously; 2) the eddy was detected from ocean color and SST images, but no eddy was detected in the altimeter data; 3) the eddy was not detected in ocean color image, while the altimeter data detected the eddy. Through these three cases, we described the difficulties with satellite altimetry data and the limitations of ocean color and infrared SST data for eddy detection. It was also emphasized that study on eddy detection and related research required an in-depth understanding of the mesoscale oceanic phenomenon and the principles of satellite observation.

The Effects of Ecklonia stolonifera Extracts on Improvement of Hepatic Function: a Double-Blind, Randomized, Placebo-Controlled Clinical Study (곰피추출물의 간기능 개선 효과 평가를 위한 12주, 무작위배정, 이중맹검, 위약-대조 인체적용시험)

  • Kim, Junghee;Kim, Eun Jin;Kang, Dahye;Kim, Hyung-Bin;Jang, Jae Young;Om, Ae-Son;Kim, Jongwook
    • Journal of Food Hygiene and Safety
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    • v.37 no.3
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    • pp.198-205
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    • 2022
  • Hepatic diseases are divided into two types: alcoholic and non-alcoholic. Non-alcoholic liver injury finally induces fatty liver and damages liver function. Many studies have demonstrated that Ecklonia stolonifera has antioxidative, anti-inflammatory, and hepatoprotective activities. We conducted a 12-week double-blind, placebo-controlled, randomized trial to examine the efficacy of E. stolonifera extracts (ESE) on biochemical markers of hepatic function. Sixty-five subjects with mild or moderate liver injuries were randomly allocated to receive either 420 mg/d of ESE or a placebo for 12 weeks. Fifty-five participants completed the trial. No significant adverse events were observed among the subjects during the study. The primary end points were changes in plasma levels of aspartate transaminase (AST), alanine transaminase (ALT), and γ-glutamyltransferase (γ-GT). The secondary end points were changes in lipid profile levels, including total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL). Compared with the baseline, AST and ALT levels decreased significantly in the ESE group compared to those in the placebo group (P<0.001). In addition, γ-GT levels in the ESE group were significantly lower than those in the placebo group (P=0.016). There were no differences in the TC, TG, HDL, and LDL levels between groups. In conclusion, ESE consumption for 12 weeks improved liver parameters in subjects with liver injury. Regular consumption of ESE could maintain liver health in individuals at risk of hepatic damage.

Simultaneous analysis of residual glucocorticoids in egg by LC/MS/MS (LC/MS/MS를 이용한 계란 중 잔류 글루코코티코이드의 동시분석)

  • Jang, Mi-Ae;Myung, Seung-Woon
    • Analytical Science and Technology
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    • v.22 no.4
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    • pp.326-335
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    • 2009
  • A specific analytical method able to identify and quantify traces of six glucocorticoids residues in eggs were developed. The extraction and clean-up parameters for simultaneous analysis were evaluated and HPLC and spectrometric conditions were also established. For determination of glucocorticoids, 5 g of egg was transferred into a test tube, adjusted pH 5.2 with acetate buffer and was $\beta$-glucuronidase/arylsulfatase from Helix pomatia added. The mixture was centrifuged and supernatant was extracted twice with 20 mL n-hexane. The extraction was performed with HLB cartridge using methanol, followed by clean-up with silica cartridge using methanol/ethyl acetate (4/6, v/v). The analytes were determined by HPLC/ESI-MS/MS operating in the negative ion mode. Validation studies with fortified egg samples for established method were performed. The result of method validation gave good efficiency, linearity, accuracy and precision. The correlation coefficients ($r^2$) of the calibration curves appeared to be higher than 0.99 in egg, indicating excellent linearity. LOD was ranged 0.09 to $0.17{\mu}g/kg$, and recoveries for most compounds were in the range of 55.7-69.8%. This method can be used to determine ${\mu}g/kg$ levels of glucocorticoids in eggs.

A Study on the Development of a Program for Predicting Successful Welding of Electric Vehicle Batteries Using Laser Welding (레이저 용접을 이용한 전기차 배터리 이종접합 성공 확률 예측 프로그램 개발에 관한 연구)

  • Cheol-Hwan Kim;Chan-Su Moon;Kwan-Su Lee;Jin-Su Kim;Ae-Ryeong Jo;Bo-Sung Shin
    • Journal of the Microelectronics and Packaging Society
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    • v.30 no.4
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    • pp.44-49
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    • 2023
  • In the global pursuit of carbon neutrality, the rapid increase in the adoption of electric vehicles (EVs) has led to a corresponding surge in the demand for batteries. To achieve high efficiency in electric vehicles, considerations of weight reduction and battery safety have become crucial factors. Copper and aluminum, both recognized as lightweight materials, can be effectively joined through laser welding. However, due to the distinct physical characteristics of these two materials, the process of joining them poses technical challenges. This study focuses on conducting simulations to identify the optimal laser parameters for welding copper and aluminum, with the aim of streamlining the welding process. Additionally, a Graphic User Interface (GUI) program has been developed using the Python language to visually present the results. Using machine learning image data, this program is anticipated to predict joint success and serve as a guide for safe and efficient laser welding. It is expected to contribute to the safety and efficiency of the electric vehicle battery assembly process.