• Title/Summary/Keyword: lR Curve

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Bioequivalence of Efexor® XR capsule to Venfaxine® OR tablet (Venlafaxine 75 mg) (이팩사® XR서방캅셀(벤라팍신, 75 mg)에 대한 벤팍신®OR서방정의 생물학적동등성)

  • Aryal, Dipendra Kumar;Oh, Soo-Yeon;Cho, Jong-Tae;Kim, Hyung-Gun;Kim, Yoon-Gyoon
    • Journal of Pharmaceutical Investigation
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    • v.37 no.6
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    • pp.397-402
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    • 2007
  • To evaluate the bioequivalence of two venlafaxine formulations, a standard 2-way randomized cross-over study was conducted in twenty-four healthy male Korean volunteers. A single oral dose of 75 mg of test formulation Venfaxine $OR^{(R)}$ (tablet) or reference formulation Efexor $XR^{(R)}$ (capsule) was administered with one-week washout period. Plasma concentrations of venlafaxine were assayed for over a period of 72 hours with a well validated method using liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS). The $mean{\pm}S.D$. of maximum concentration $(C_{max})$ and elimination half-life $(t_{1/2})$ were $64.7{\pm}28.5$ ng/mL, $9.2{\pm}3.0$ h, and $67.2{\pm}30.2$ ng/mL, $9.9{\pm}3.5$ h for test and reference formulations, respectively. Time to reach maximum concentration $(T_{max})$ expressed in median value (range), for the test and the reference, were 10 h (6-14) and 8h (4-12), respectively. Similarly, area under the plasma concentration-time curve, from time zero to last sampling time $(AUC_t)$ and from time zero to time infinity $(AUC_{inf})$, for test and reference formulations were $1185{\pm}755$, $1326{\pm}896$ and $1124{\pm}737$, $1185{\pm}755$ $ng{\cdot}h/mL$, respectively. The parametric 90% confidence intervals on the mean of the differences between the two formulations (test-reference) of the log transformed values of $AUC_t$, and $C_{max}$ were 0.9630 to 1.1383 and 0.8650 to 1.0446, respectively. The overall results indicate that the two formulations are bioequivalent and can be prescribe interchangeably.

Validation of an analytical method of dieckol for standardization of Ecklonia cava extract as a functional ingredient (감태추출물의 기능성원료 표준화를 위한 지표성분 dieckol의 분석법 검증)

  • Xu, Yan;Kim, Eun Suh;Lee, Ji-Soo;Kim, Gun-Hee;Lee, Hyeon Gyu
    • Korean Journal of Food Science and Technology
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    • v.51 no.5
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    • pp.420-424
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    • 2019
  • An HPLC analysis method was developed and standardized for the detection of dieckol as a functional food ingredient in Ecklonia cava extracts. HPLC was performed using a Capcell Pak C18 column ($250{\times}4.6mm$, $5{\mu}m$) with a gradient elution of water and acetonitrile, both containing 0.1% (v/v) trifluoroacetic acid, at a flow rate of 1.0 mL/min at $25^{\circ}C$. The eluate was detected at 230 nm. For validation, the specificity, linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ) of dieckol were measured. The calibration curve for the detection of dieckol had high linearity ($R^2=0.9994$), with LOD and LOQ values of 0.38 and $1.16{\mu}g/mL$, respectively. Recovery of the quantified compound ranged from 99.61 to 100.71%. The relative standard deviation values of the intra-day and inter-day precisions were less than 1.7 and 1.25%, respectively. These results indicate that the reported HPLC method is simple, reliable, and reproducible for the detection of dieckol in Ecklonia cava extracts.

Quantification of White Spot Syndrome Virus (WSSV) in Seawaters Using Real-Time PCR and Correlation Analyses between WSSV and Environmental Parameters (Real-Time PCR을 이용한 해수 존재 흰반점 바이러스의 정량 및 양식 환경인자와의 상관관계 분석)

  • Song, Jae-Ho;Choo, Yoe-Jin;Cho, Jang-Cheon
    • Korean Journal of Microbiology
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    • v.44 no.1
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    • pp.49-55
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    • 2008
  • White Spot Syndrome Virus (WSSV) is one of the most virulent viral agents in the penaeid shrimp culture industry. In this study, WSSV in a Fenneropenaeus chinensis shrimp farm and an adjacent seawater were concentrated using a membrane filtration and quantified using the quantitative real-time PCR (QRT-PCR) method with newly designed primers and Taqman probe. Sensitivity of primers and probe was proven by WSSV standard curve assay in QRT-PCR. In order to demonstrate the relationship between WSSV and environmental parameters, physicochemical and biological parameters of the farm and influent seawaters were monitored from June to September, 2007. The abundance of WSSV ranged 3,814-121,546 copies per 1 liter of seawater, which was correlated with fecal enterococci ($r^2=0.9$, p=0.02), chlorophyll ${\alpha}$ ($r^2=0.8$, p=0.03) and $BOD_5$ ($r^2=0.8$, p=0.07). Subsequently, it is concluded that the QRT-PCR method using Taqman probe established in this study was efficient to clarify the quantification of WSSV in seawaters. Statistical analyses of environmental parameters obtained in this study also showed that the abundance of WSSV was correlated with several biological parameters rather than physicochemical parameters.

DETERMINATIONS OF ITS ABSOLUTE DIMENSIONS AND DISTANCE BY THE ANALYSES OF LIGHT AND RADIAL-VELOCITY CURVES OF THE CONTACT BINARY - I. V417 Aquilae (접촉쌍성의 광도와 시선속도곡선의 분석에 의한 절대 물리량과 거리의 결정 -1. V417 Aquilae)

  • 이재우;김천휘;이충욱;오규동
    • Journal of Astronomy and Space Sciences
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    • v.21 no.2
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    • pp.73-82
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    • 2004
  • New photometric and spectroscopic solutions of W-type overcontact binary V 417 Aql were obtained by solving the UBV light curves of Samec et al. (1997) and radial-velocity ones of Lu & Rucinski (1999) with the 2003 version of the Wilson-Devinney binary code. In the light curve synthesis the light of a third-body, which Qian (2003) proposed, was considered and obtained about 2.7%, 2.2%, and 0.4% for U, B, and V bandpasses, respectively. The model with third-light is better fitted to eclipse parts than that with no third-light. Absolute dimensions of V417 Aql are determined from our solution as $M_1$= 0.53 $M_{*}$, $M_2$= 1.45 $M_{*}$, $R_1$= 0.84 $R_{*}$, and $R_2$= 1.31 $M_{*}$, and the distance to it is deduced as about 216pc. Our distance is well consistent with that (204pc) derived from Rucinski & Duerbeck's (1997) relation, $M_{v}$ = $M_{v}$(log P, B-V), but is more distant than that (131$\pm$40pc) determined by the Hipparcos trigonometric parallax. The difference may result from the relatively large error of Hipparcos parallax for V 417 Aql.l.

Bioequivalence of Atorva Tablet® to Lipitor Tablet® (Atorvastatin 20 mg) (리피토정® (아토르바스타틴 20 mg)에 대한 아토르바정®의 생물학적동등성)

  • Lim, Hyun-Kyun;Lee, Tae-Ho;Lee, Jae-Hyun;Youm, Jeong-Rok;Song, Jin-Ho;Han, Sang-Beom
    • Journal of Pharmaceutical Investigation
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    • v.38 no.2
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    • pp.135-142
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    • 2008
  • The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor $Tablet^{(R)}$ (Pfizer, reference drug) and Atorva $Tablet^{(R)}$ (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a $2{\times}2$ crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were complied trom the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Atorva $Tablet^{(R)}$ / Lipitor $Tablet^{(R)}$ were ${\log}\;0.9413{\sim}{\log}\;1.0179$ and ${\log}\;0.831{\sim}{\log}\;1.0569$, respectively. These values were within the acceptable bioequivalence intervals of ${\log}\;0.8{\sim}{\log}\;1.25$. Based on these statistical considerations, it was concluded that the test drug, Atorva $Tablet^{(R)}$ was bioequivalent to the reference drug, Lipitor $Tablet^{(R)}$.

Validation of Analytical Method of Marker Compounds in Extract of Pear Pomace as a Functional Health Ingredient (건강기능식품 원료로서 나주 배박 추출물의 지표성분 분석법 벨리데이션)

  • Cho, Eun-Jung;Bang, Mi-Ae;Cho, Seung-Sik
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.44 no.11
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    • pp.1682-1686
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    • 2015
  • This study was conducted to establish an HPLC analysis method for determination of marker compounds as part of materials standardization for development of health functional food materials from pear pomace. The quantitative determination method of caffeic acid and chlorogenic acid as marker compounds of pear pomace extract (PPE) was optimized by HPLC analysis using a C18 column ($5{\times}250mm$, $5{\mu}m$) with a 0.2% elution gradient of acetic acid and methanol as the mobile phase at a flow rate of 0.8 mL/min and detection wavelength of 330 nm. The HPLC/UV method was applied successfully to the quantification of marker compounds in PPE after validation of the method with linearity, accuracy, and precision. The method showed high linearity of the calibration curve with a coefficient of correlation ($R^2$) of 0.9999, and limit of detection and limit of quantification were $1.14{\mu}g/mL$ (caffeic acid) and $1.61{\mu}g/mL$ (chlorogenic acid) as well as $4.9{\mu}g/mL$ (caffeic acid) and $4.9{\mu}g/mL$ (chlorogenic acid), respectively. Relative standard deviation values from intra- and inter-day precision were less than 3.1% (caffeic acid) and 4.0% (chlorogenic acid), respectively. Recovery rates of caffeic acid and chlorogenic acid at 12.5, 25, and $50{\mu}g/mL$ were 93.66~106.32% and 97.33~105.68%, respectively. An optimized method for extraction of caffeic acid and chlorogenic acid in PPE was established through diverse extraction conditions, and the validation indicated that the method is very useful for evaluation of marker compounds in PPE to develop a health functional food material.

Variation of Fatigue Properties in Nanoskinned Ti-6Al-4V - Rotating Bending and Axial Loading Tension-Compression Cycle - (Ti-6Al-4V 재의 UNSM 처리에 의한 피로특성변화 - 회전굽힘 피로시험과 축하중 인장압축 피로시험 비교 -)

  • Suh, Min-Soo;Pyoun, Young-Shik;Suh, Chang-Min
    • Transactions of the Korean Society of Mechanical Engineers A
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    • v.36 no.4
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    • pp.443-449
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    • 2012
  • Nanoskins were fabricated on a Ti-6Al-4V material by carrying out various surface treatments, i.e., deep rolling, laser shot peening, and ultrasonic nanocrystal surface modification (UNSM). These surface treatments are newly developed techniques and are becoming more popular for industrial applications. Fatigue tests were carried out using material test system (MTS); these tests included the axial loading tension-compression fatigue test (R = -1, RT, 5 Hz, sinusoidal wave) and rotating bending fatigue test (R = -1, RT, 3200 rpm). The analysis of the crack initiation pattern in the UNSM-treated material indicated that the crack was interior originating in the axial loading tension-compression cycle, and was surface originating in the bending fatigue test. UNSM treatment significantly improved the fatigue strength for the regime of above $10^6$ cycles that S-N curve of rotating bending stress clearly show the performance of a 5 mm titanium specimen after UNSM treatment is similar to that of an untreated 6 mm titanium specimen.

Relationship between the abdominal sagging index and the reproductive performance of the Roman goose

  • S. C. Chang;M. J. Lin;L. J. Lin;S. Y. Peng;Tzu Tai Lee
    • Animal Bioscience
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    • v.36 no.4
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    • pp.584-590
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    • 2023
  • Objective: This research aimed to explore the changes in the observed abdominal sagging index (ASI) and reproductive performance of Roman male and female geese during the breeding period. Methods: The 339 six-month-old breeding geese (109 male; 230 female) were used in this study, in which five male and five female geese were slaughtered on a monthly basis to record the ASI. Results: The short diameter of the testes of the male goose when the female goose lays eggs and in the second, third, and fourth months was significantly wider than in the fifth months (19.0, 20.8, 21.4, and 19.6 vs 12.7 and 14.0 mm/bird; p = 0.0105). On the other hand, the testicular weight of the male goose in the second and third months after the female goose lays eggs was significantly higher than that in the second and fifth months after laying (0.33% and 0.37% vs 0.11% and 0.19%; p = 0.0212). During the exploring period, the length and weight of the fallopian tube, the weight of the ovary, the number of follicles in 2 to 3 cm, the number of follicles in 3 to 4 cm, the fallopian tube weight in the carcass weight percentage, and the ovary weight in the carcass weight percentage all demonstrated a significant curve response. Further, female ASI was positively correlated with reproductive tract length (r = 0.815; p<0.05) and egg production per female (r = 0.790; p<0.05). Conclusion: The ASI classification method is more objective and easy to distinguish. This scoring method has a high correlation with the number of eggs laid by each goose and the length of the reproductive tract, inferring that the goose observation could take advantage of ASI during egg-laying and can predict the reproductive system development during the laying period and determine when the breeding goose begins to lay eggs.

Evaluation of the Method for Total Homocysteine in Plasma Using LC-MS/MS (LC-MS/MS를 이용한 Homocysteine 측정과 그 유용성 평가)

  • Jun, Sun-Hee;Lim, Mi-Suk;Jung, Yong-Sun;Song, Jung-Han
    • Korean Journal of Clinical Laboratory Science
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    • v.37 no.1
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    • pp.22-26
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    • 2005
  • Total homocysteine is now considered a risk factor for cardiovascular diseases. I increased interest has led to a multitude of studies requiring the determination of total homocysteine in conjunction with other factor. There are various methods for measuring total homocysteine, including HPLC, FPIA, GC-MS and LC-MS/MS. The most recent method for measuring total homocysteine uses a deuterium-labelled internal standard and tandem mass spectrometry. This development requires no derivatization and therefore leads to an increase in sample throughput compared to other techniques. We have evaluated the method for homocysteine by the LC-MS/MS method, and the correlation between the FPIA method and the LC-MS/MS method. The standard curve (0, 5, 10, 20, 50, 100 uM) was linear over the range examined (up to 100 uM). The lower limit of quantification (CV < 10 %) was 0.5 uM/L and the lower limit of detection (S/N >3) was 0.1 uM/L. Intra-assay variation and inter-assay variation were both <6 %. The comparision study for homocysteine concentration showed good correlation (r=0.9684) between the FPIA method and LC-MS/MS methods. Our conclusion is that the method showed relatively good precision, and was rapid and accurate.

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Biodegradation of Diazinon by Serratia marcescens DI101 and its Use in Bioremediation of Contaminated Environment

  • Abo-Amer, Aly E.
    • Journal of Microbiology and Biotechnology
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    • v.21 no.1
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    • pp.71-80
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    • 2011
  • Four diazinon-degrading bacteria were isolated from agricultural soil by using an enrichment technique. The biochemical analysis and molecular method including RFLP indicated that these isolates were identical, and one strain designated DI101 was selected for further study. Phylogenetic analysis based on 16S rDNA sequencing indicated that the strain DI101 clearly belongs to the Serratia marcescens group. The ability of the strain to utilize diazinon as a source of carbon and phosphorus was investigated under different culture conditions. The DI101 strain was able to completely degrade 50 mg/l diazinon in MSM within 11 days with a degradation rate of 0.226 $day^{-1}$. The inoculation of sterilized soil treated with 100 mg/kg of diazinon with $10^6$ CFU/g DI101 resulted in a faster degradation rate than was recorded in non-sterilized soil. The diazinon degradation rate by DI101 was efficient at temperatures from 25 to $30^{\circ}C$ and at pHs from 7.0 to 8.0. The degradation rate of diazinon was not affected by the absence of a phosphorus supplement, and addition of other carbon sources (glucose or succinate) resulted in the slowing down of the degradation rate. The maximum degradation rate ($V_{max}$) of diazinon was 0.292 $day^{-1}$ and its saturation constant ($K_s$) was 11 mg/l, as determined by a Michaelis-Menten curve. The strain was able to degrade diethylthiophosphate-containing organophosphates such as chlorpyrifos, coumaphos, parathion, and isazofos when provided as a source of carbon and phosphorus, but not ethoprophos, cadusafos, and fenamiphos. These results propose useful information for the potential application of the DI101 strain in bioremediation of pesticide-contaminated environments.