A bioequivalence study of $Roxithrin^{TM}$ tablet (Kukje Pharma. Ind. Co., Ltd.) to $Rulid^{TM}$ tablet (Han Dok Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the roxithromycin dose of 300 mg in a $2{\times}2$ crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography for over a period of 36 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 36 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 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 cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Roxithrin^{TM}/Rulid^{TM}$ were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of $Roxithrin^{TM}$ and $Rulid^{TM}$ with respect to the rate and extent of absorption.
In this study simple and sensitive high performance liquid chromatographic method using a commercially available column, was developed and validated for the determination of zolpidem tartrate in human plasma. The developed method with suitable validation was applied to a bioequivalence study of two different kinds of zolpidem tartrate. Two different formulations containing 10 mg of zolpidem tartate (CAS : 99294-93-6) were compared in 24 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, cross-over design in 24 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 12 h. The mean $AUC_{0-12h}$, $C_{max}$, $T_{max}$ and $T_{1/2}$ were $676.6{\pm}223.4$$ng{\cdot}h{\cdot}mL^{-1}$, $177.4{\pm}34.2$$ng{\cdot}mL^{-1}$, and $0.8{\pm}0.4$ and $3.5{\pm}2.1$, respectively, for the test formulations, and $640.7{\pm}186.6$$ng{\cdot}h{\cdot}mL^{-1}$, $193.0{\pm}64.5$$ng{\cdot}mL^{-1}$, and $0.9{\pm}0.4$ and $2.7{\pm}0.9$, respectively, for the reference formulation. Both primary target parameters $AUC_{0-12h}$ and $C_{max}$ were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of $AUC_{0-12h}$ and $C_{max}$ were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of zolpidem tartate are considered to be bioequivalent.
Kim, Tae-Wan;Song, Ok-Kyoung;Han, Sun-Young;Cao, Qing-Ri;Park, Mi-Jin;Kang, Sung-Ha;Shin, Kwan-Seog;Cui, Jing-Hao;Lee, Beom-Jin
Journal of Pharmaceutical Investigation
/
v.35
no.2
/
pp.117-122
/
2005
After establishing improved HPLC analytical method of cefaclor in human plasma samples, a bioavailability study of cefaclor capsules was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). The standard calibration curve using an HPLC with UV detector was constructed in a range of $0.0324{\sim}16\;{\mu}g/ml$. The 6% perchloric acid instead of 6% trichloroacetic acid was used to precipitate plasma protein. The HPLC chromatograms were precisely and accurately resolved when spiked with human plasma spiked with cefaclor and cephalexin (internal standard). Twenty healthy male Korean volunteers received two commercial cefaclor capsules, $Neocef^{\circledR}$ capsule (Jinyang Pharm. Co., Ltd) or $Ceclor^{\circledR}$ capsule (Lilly Korea. Co., Ltd.) at the 250 mg cefaclor in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of cefaclor were monitored for 8 hours after oral drug administration. $AUC_t$ the area under the plasma concentration-time curve from time zero to 8 hr (13 points), 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 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 cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Neocef^{\circledR}/Ceclor^{\circledR}$ were $0.9049{\leq}{\delta}{\leq}1.226$, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Neocef^{\circledR}/Ceclor^{\circledR}$ with respect to the extent of absorption.
The Journal of Korean Institute of Electromagnetic Engineering and Science
/
v.17
no.5
s.108
/
pp.461-475
/
2006
In this paper, it is described about the tri-band mobile antenna system design to provide broadband multimedia and direct broadcasting services using goo-stationary Koreasat 3, simultaneously operated in Ka/K/Ku band. The radiating part of the antenna system with a fan beam characteristic in the elevation plane is composed of the quasi-offset dual shaped reflector and the tri-band feeder. The tri-band feeder is also composed of the Ka/K dual band feeder with the protruding dielectric rod, the circular polarizer, the ortho-mode transducer and the circular-polarized Ku band feed array. Especially, the Ka/K dual band circular polarizer was realized firstly using the comb-type structure. For fast satellite-tracking on the movement, the Ku band feed array has the structure of the $2{\times}2$ active phased array which can make electrical beams. And, the circular-polarized characteristic in the feed array was improved by $90^{\circ}$ rotating arrangement of four radiating elements polarized circularly by a $90^{\circ}$ hybrid coupler, respectively. Four beam forming channels to make electrical beams at Ku band are divided into the main beam channel and the tracking beam channel in the output, and noise temperature characteristics of each channel were analyzed on the basis of the contributions of internal sub_units. From the fabricated antenna system, the output power at $P_{1dBc}$ of Ka_Tx channel was measured more than 34.1 dBm and the measured noise figures of K/Ku_Rx channels were less than 2.4 dB and 1.5 dB, respectively, over the operating band. The radiation patterns with co- and cross-polarization in the tri-band were measured using a near-field measurement in the anechoic chamber. Especially, Ku radiation patterns were measured after correcting each initial phase of active channels with partial radiation patterns obtained from the independent excitation of each channel. The antenna gains measured in Ka/K/Ku band of the antenna system were more than 39.6 dBi, 37.5 dBi, 29.6 dBi, respectively. And, the antenna system showed good system performances such as Ka_Tx EIRP more than 43.7 dBW and K/Ku_Rx G/T more than 13.2 dB/K and 7.12 dB/K, respectively.
This study was designed to compare the absorption fraction and extent of ketoprofen gels and a matrix typed ketoprofen plaster patch. 3g (90mg as ketoprofen) of the two gels whi ch has oleohydrogel or hydrogel as a base, respectively, and 3 pieces of plaster patches (90mg as ketoprofen) were, applied in the area of 210$cm^2$ on forearm in 12 volunteers by cross over design. Blood samples were collected serially up to 24 hours and the plasma concentrations of ketoprofen were analyzed by HPLC using flurbiprofen as an internal standard. The detection limit of the assay was 1ng/ml of ketoprofen in plasma. The pharmacokinetic parameters (e.g. $AUC_{24hr}$, $AUMC_{24hr}$, MRT, Fraction Absorbed) were calculated from the plasma concentrations time data of each volunteer. The oleo-hydrogel showed significantly higher absorption fraction and extent of ketoprofen than the current hydrogel. The mean plasma concentrations of the oleo-hydrogel were increased to 98.46${\pm}$23.15ng/ml by 6 hour after application, and increased futher to 100.61${\pm}$18.65ng/ml at 24 hour. On the other hand, those of the hydrogel were increased 17.61${\pm}$18.65ng/ml at 5 hour to 34.68${\pm}$9.65ng/ml at 24 hour gradually. Therefore the plasma concentrations of oleo-hydrogel at each measured time were 3~7 times greater than those of the hydrogel with statistical significance. The $AUC_{24hr}$ (1797.26${\pm}$52.09ng.h/ml) of the oleo-hydrogel was 3.5 times greater (P<0.05) than that (516.17${\pm}$104.52ng.h/ml) of the hydrogel. The plaster patches showed higher bioavailability ($AUC_{24hr}$ 2877.37${\pm}$578.27ng.h/ml) than the olea-hydrogel ($AUC_{24hr}$ 1797.26${\pm}$52.09ng.h/ml) without statistical significance. But the absorption fraction of the oleo-hydrogel was rather higher than that of the plaster patches during the first 6 hours after administration. These results suggest that newly developed ketoprofen gel which is used oleo-hydrogel as a base would show excellent skin permeation on topical application for the corresponding clinical indications and could be absorbed as well as plaster patches.
Kim, Tae-Wan;Cao, Qing-Ri;Han, Sun-Young;Song, Ok-Kyoung;Sin, Kwan-Seog;Kang, Sung-Ha;Lee, Beom-Jin
Korean Journal of Clinical Pharmacy
/
v.15
no.1
/
pp.21-26
/
2005
A bioequivalence study of CKD $Cefaclor^{(R)}$ capsule (Chong Kun Dang Pharm Co., Ltd) to $Ceclor^{(R)}$ capsule (Lilly Korea Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the cefaclor dose of 250 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. An improved high-performance liquid chromatorgraphy (HPLC) analytical method with UV detection was used to determine plasma cefaclor concentration in human volunteers for 8 hr after oral drug administration. The area under the plasma concentration-time curve from time zero to 8 hr ($AUC_{0-8hr}$) was calculated by the linear trapezoidal rule. the $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_{0-8hr}\;and\;C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The $90{\%}$ confidence intervals of the $AUC_{0-8hr}$ ratio and the $C_{max}$ ratio for CKD $Cefaclor^{(R)}$ and $Ceclor^{(R)}$ were $0.9400{\leq}{\delta}{\leq}1.0345$ and $0.8858{\leq}{\delta}{\leq}1.1021$, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the of CKD $cefaclor^{(R)}$ capsule was bioequivalent to $Cefaclor^{(R)}$ capsule with respect to its bioavailability.
Proceedings of the Korea Water Resources Association Conference
/
2015.05a
/
pp.237-237
/
2015
The district of Marlborough has had more than its share of river management projects over the past 150 years, each one uniquely affecting the geomorphology and flood hazard of the Wairau Plains. A major early project was to block the Opawa distributary channel at Conders Bend. The Opawa distributary channel took a third and more of Wairau River floodwaters and was a major increasing threat to Blenheim. The blocking of the Opawa required the Wairau and Lower Wairau rivers to carry greater flood flows more often. Consequently the Lower Wairau River was breaking out of its stopbanks approximately every seven years. The idea of diverting flood waters at Tuamarina by providing a direct diversion to the sea through the beach ridges was conceptualised back around the 1920s however, limits on resources and machinery meant the mission of excavating this diversion didn't become feasible until the 1960s. In 1964 a 10 m wide pilot channel was cut from the sea to Tuamarina with an initial capacity of $700m^3/s$. It was expected that floods would eventually scour this 'Wairau Diversion' to its design channel width of 150 m. This did take many more years than initially thought but after approximately 50 years with a little mechanical assistance the Wairau Diversion reached an adequate capacity. Using the power of the river to erode the channel out to its design width and depth was a brilliant idea that saved many thousands of dollars in construction costs and it is somewhat ironic that it is that very same concept that is now being used to deal with the aggradation problem that the Wairau Diversion has caused. The introduction of the Wairau Diversion did provide some flood relief to the lower reaches of the river but unfortunately as the Diversion channel was eroding and enlarging the Lower Wairau River was aggrading and reducing in capacity due to its inability to pass its sediment load with reduced flood flows. It is estimated that approximately $2,000,000m^3$ of sediment was deposited on the bed of the Lower Wairau River in the time between the Diversion's introduction in 1964 and 2010, raising the Lower Wairau's bed upwards of 1.5m in some locations. A numerical morphological model (MIKE-11 ST) was used to assess a number of options which led to the decision and resource consent to construct an erodible (fuse plug) bank at the head of the Wairau Diversion to divert more frequent scouring-flows ($+400m^3/s$)down the Lower Wairau River. Full control gates were ruled out on the grounds of expense. The initial construction of the erodible bank followed in late 2009 with the bank's level at the fuse location set to overtop and begin washing out at a combined Wairau flow of $1,400m^3/s$ which avoids berm flooding in the Lower Wairau. In the three years since the erodible bank was first constructed the Wairau River has sustained 14 events with recorded flows at Tuamarina above $1,000m^3/s$ and three of events in excess of $2,500m^3/s$. These freshes and floods have resulted in washout and rebuild of the erodible bank eight times with a combined rebuild expenditure of $80,000. Marlborough District Council's Rivers & Drainage Department maintains a regular monitoring program for the bed of the Lower Wairau River, which consists of recurrently surveying a series of standard cross sections and estimating the mean bed level (MBL) at each section as well as an overall MBL change over time. A survey was carried out just prior to the installation of the erodible bank and another survey was carried out earlier this year. The results from this latest survey show for the first time since construction of the Wairau Diversion the Lower Wairau River is enlarging. It is estimated that the entire bed of the Lower Wairau has eroded down by an overall average of 60 mm since the introduction of the erodible bank which equates to a total volume of $260,000m^3$. At a cost of $$0.30/m^3$ this represents excellent value compared to mechanical dredging which would likely be in excess of $$10/m^3$. This confirms that the idea of using the river to enlarge the channel is again working for the Wairau River system and that in time nature's "excavator" will provide a channel capacity that will continue to meet design requirements.
Kim, Jae-Woo;Kong, Sung-A;Lee, On;Jin, Cheng-Zhu;Kim, Yeon-Soo
The Korean Journal of Community Living Science
/
v.20
no.1
/
pp.81-89
/
2009
The purpose of this study was to analyze the patterns and interrelationships for meeting recommendations of physical activity, sedentary behavior, and dietary behavior in elementary school students. A cross-sectional design was used to assess 259 students ages 11 to 13 years. Physical activity (moderate to vigorous physical activity $\geqq$60min/day), sedentary behavior (viewing time for TV, computer, DVD, video, etc<3hr/day), and dietary behavior (servings of fruits and vegetables$\geqq$5times/day) were categorized into two levels: meeting recommendations or not meeting recommendations. Parents' health behaviors and home environmental variables were assessed with self-reported measures. Chi-squared tests and independent t-tests were conducted to compare anthropometric variables and the prevalence of students not meeting the recommendation for the three health behaviors. Comparison between males and females and logistic linear regression were used to determine the interrelationships of three health behaviors. 25.9% of students did not meet the physical activity recommendations. 15.4% did not meet sedentary behavior recommendations, and 41.7% did not meet dietary recommendation. Only 39.8% of students met all three recommendations, but 19.0% did not meet over two recommendations. Patterns that simultaneously did not meet two recommendations were: sedentary and dietary behavior in males (8.1%), and physical activity and dietary behavior in females (10.4%). Students who did not meet dietary recommendations were at greater risk of not meeting physical activity (OR 2.76; 95% CI 1.15 to 6.64), and sedentary behavior (OR 3.07; 95% CI 1.15 to 8.16) compared with students who did meet dietary recommendations. The findings of this study support not an independent behavior approach but a multiple behavior approach taking into account gender and interrelationships among the three behaviors.
This study, consisting of two experiments, was conducted to determine the effects of feeding heat treated protein and mineral complex (HPM) on milk production and composition, and ruminal fermentation of Holstein dairy cows. In in vitro experiment, HPM levels were 0, 0.2, 1 and 2%, and Timothy hay, which was substrate, was milled as 1 mm size, and the effects of HPM on pH, ammonia and VFA were analyzed after incubation times of 0, 6, 12, 24 and 48 h, respectively. The pH and ammonia production were not significantly different between treatments during the incubation. In addition, generally, total VFA and individual VFA were not affected by HPM on 0, 6 and 24 h. While, total VFA and individual VFA were increased in 0.2% and 1% of HPM supplemented treatments, but decreased in 2% of HPM treatment compared with control on 12 h. On 48 h, total VFA and individual VFA were increased in HPM treatments compared to control (P<0.05). However, A/P ratio was not affected by HPM supplementation. Gas production was higher in HPM treatment compared to control on 24 h (P<0.05) and 48 h (P<0.05). In lactating experiment, fourteen lactating Holstein cows were used for 4 months in a cross over experimental design. There were two treatments; no added HPM as a control and 0.2% of HPM added as a test treatment. Daily milk yield (P<0.001), 4% FCM (P<0.001), milk protein (P<0.05) and SNF (solid not fat; P<0.05) were increased in HPM treatment compared to control. While, milk fat, MUN (milk urea nitrogen) and SCC (somatic cell count) were not significantly different between treatments.
Journal of Korean Academy of Nursing Administration
/
v.3
no.1
/
pp.119-133
/
1997
Continuing shift service of clinical nurses can be not only the cause of occupational dissatisfaction by being connected with the change of circadian rhythm and the burden of duties to be applicable to such changes. But also of inviting the lowering of nursing quality by being affected to the resignation of the nurses as the threat to the health of the nurses. This study has selected 500 nurses at random under non-probability sampling who have been serving by shift in 7 general hospitals which have over 400 sickbeds for the purpose of cross-sectional survey design from Sep. 7 through 20, 1996. Standardized modification of the CMI has been used which was designed for Koreans with Cornell Medical Index developed by Broadman and his fellow workers as the study device. The structure of the device was composed of 35 questions on physical appeal(Chronbach's ${\alpha}=8507$) and 22 questions of mental appeal(Cronbach's ${\alpha}=.8166$ totalling 57 questions. The collected data has been computerrized by using SPSS. General character, present symptom, perceived symptom and others are sought by practical number and percentage, and the health condition comparison followed by general characters was conducted by t-test and ANOVA. The post test was by Duncan's test by the level of p<.05. 1) The items of the answer that they have the physical symptom presently by 50% or over of the nurses were as "Do you often have spells of severe dizziness", "Are your eyes often red or inflamed", "Does press or pain in the head often make like miserable", "Are your ankles often badly swollen", "Do pains in the back make it hard for you to keep up with your work". 2) The items of the answer by over 50% of the nurses as the mental symptom at present were "do you fell bad when criticized?", "Do you get angry when everything is against your will?", "do you get angry when ordered to do this and that?", "do you feel uneasy by such a trifle thing?", "do you tremble or are you freightened by sudden sound?". The mental and physical symptoms which have appeared presently in connection with the shift service have been agreed with each other. But the physical condition has been worse than the mental one. 3) In the physical health conditions followed by demosociological character, there were the significant differences by sex, religion and place of residence(p<.05), and in the mental health conditions, there were the significant differences by age, marital status, residence place and the required time for attending hospital(p<.05). 4) There was significant difference by the degree of satisfaction about the duty in both the physical and mental health conditions. In short, the higher the degree of duty satisfaction, the better the health conditions. 5) There were the significant difference according to the times of night duty and whether they take the drug or not or the kinds of the drugs in the physical health conditions related with the characters of night shift. Mental health conditions in the night shift case showed significant differences according to their taking drug or not or the kinds of the drugs(p<.05). I can confirm that the nurses have been affected continuously by the shift service mentally and physically. The maintenance of the physical and mental health of the nurses and its promotion are very important problem to guarantee the quality nursing in the performance of the nursing service continuously and effectively, so the hospital should make every effort to improve the duty conditions by finding out the causes affecting to their health. In the nursing management viewpoint, I think that elevating the satisfaction degree about the duty would be a great help to the promotion of physical and mental health conditions. But what is most important is that the nurses themselves should take care of themselves in maintaining the good conditions in their service in the hospital.
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