Famciclovir is an oral prodrug of the antiherpesvirus nucleoside analogue, penciclovir. In human, famciclovir is orally well absorbed and then undergoes extensive first pass metabolism to penciclovir and essentially no parent compound is recovered from plasma or urine. The purpose of the present study was to evaluate the bioequivalence of two famciclovir tablets, $Famvir^{TM}$ tablet 250 mg (Novartis Korea Ltd.) and Famcivir (Hanmi Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of famciclovir from the two famciclovir formulations in vitro was tested using KP VIII Apparatus II method with water. Twenty six healthy male subjects, $24.19{\pm}2.08$ years in age and $71.55{\pm}6.89$ 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 250 mg as famciclovir was orally administered, blood samples were taken at predetermined time intervals and the concentrations of penciclovir in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar at water. 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, $Famvir^{TM}$ tablet 250 mg, were -2.93, -8.02 and 10.47% 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 log0.8 to log1.25 (e.g., $log0.92{\sim}log1.01$ and $log0.85{\sim}log1.00$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Famcivir was bioequivalent to $Famvir^{TM}$ tablet 250 mg.
Kim, Se-Mi;Yoon, Hwa;Yoo, Hee-Doo;Kim, Kyung-Ran;Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
Journal of Pharmaceutical Investigation
/
v.38
no.3
/
pp.199-205
/
2008
Famciclovir, 9-(4-hydroxy-3-hydroxymethylbut-1-yl) guanine, is an oral prodrug of the antiherpesvirus nucleoside analogue, penciclovir. In human, famciclovir is orally well absorbed and then undergoes extensive first pass metabolism to penciclovir and essentially no parent compound is recovered from plasma or urine. The purpose of the present study was to evaluate the bioequivalence of two famciclovir tablets, Famvir tablet 750 mg (Novartis Korea Ltd.) and Famcivir tablet 750 mg (Hanmi Pharmaceutical. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of famciclovir from the two famciclovir formulations in vitro was tested using KP VIII Apparatus II method with water. Twenty six healthy male subjects, $23.38{\pm}1.72$ years in age and $68.59{\pm}7.84\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 750 mg as famciclovir was orally administered, blood samples were taken at predetermined time intervals and the concentrations of penciclovir in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations ere similar at water. 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, $Famvir^{(R)}$ tablet 750 mg, were -0.53%, 1.12% and -24.82% 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., $log\;0.9569{\sim}log\;1.0423$ and $log\;0.8763{\sim}log\;1.2136$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Famcivir tablet 750 mg was bioequivalent to Famvir tablet 750 mg.
Ibudilast, 3-isobutyryl-2-isopropyrazolo[1,5-a]pyridine, is a nonselective inhibitor of cyclic nucleotide phosphodiesterase (PDE). It preferentially inhibits PDE 3A, PDE4, PDE10 and PDE11 as well as a number of the other PDE families, albeit to a lesser extent. Ibudilast is used clinically to treat bronchial asthma and cerebrovascular disorders. Thes e clinical uses are based on the ability of ibudilast to inhibit platelet aggregation, improve cerebral blood flow and attenuate allergic reactions. The purpose of the present study was to evaluate the bioequivalence of two ibudilast capsules, Ketas capsule (Handok Pharmaceuticals Co., Ltd.) and Pinatos capsule (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of ibudilast from the two ibudilast formulations was tested using KP Apparatus method with various dissolution media. Twenty six healthy male subjects, 23.31${\pm}$1.09 years in age and 70.45${\pm}$8.51 kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single capsule containing 10 mg as ibudilast was orally administered, blood samples were taken at predetermined time intervals and the concentrations of ibudilast in serum were determined using HPLC/UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were 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, Ketas, were 6.99%, -2.48% and 9.93% 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 0.8791~log 1.1861 and log 0.8347~log 1.1199 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Pinatos capsule was bioequivalent to Ketas capsule.
Lethal effects of high voltage pulsed electric fields (PEF) on suspensions of Lactobacillus plantarum cells in phosphate buffer solution were examined by using continuous recycle treatment system. Critical electric field strength and treatment time needed for inactivation of L. plantarum were 13.6 kV/cm and $16.1\;{\mu}s$ at room temperature, respectively. As decrease in frequency (decreasing pulse number), the degree of inactivation of L. plantarum was increased. A 2.5 log reduction in microbial population could be achieved with an electric field strength of 80 kV/cm, 300 Hz frequency and $2000\;{\mu}s$ treatment time. Survivability was decreased with increase in total treatment time (cycle number) and frequency at the same cycle number. As sterilization model of continuous recycle PEF treatment, $logS=-N_m\;log\;m+B$ and $N_m=k_1\;P_n+k_2$ were established. This model was very well fitted to tile empirical data. The rate of inactivation increased with increase in the processing temperature. The maximum reduction in survivability (5.6 log reduction) was obtained with 80 kV/cm electric field strength at $50^{\circ}C$ for $1000\;{\mu}s$ treatment.
The gas hydrate exploration using seismic reflection data, the detection of BSR(Bottom Simulating Reflector) on the seismic section is the most important work flow because the BSR have been interpreted as being formed at the base of a gas hydrate zone. Usually, BSR has some dominant qualitative characteristics on seismic section i.e. Wavelet phase reversal compare to sea bottom signal, Parallel layer with sea bottom, Strong amplitude, Masking phenomenon above the BSR, Cross bedding with other geological layer. Even though a BSR can be selected on seismic section with these guidance, it is not enough to conform as being true BSR. Some other available methods for verifying the BSR with reliable analysis quantitatively i.e. Interval velocity analysis, AVO(Amplitude Variation with Offset)analysis etc. Usually, AVO analysis can be divided by three main parts. The first part is AVO analysis, the second is AVO modeling and the last is AVO inversion. AVO analysis is unique method for detecting the free gas zone on seismic section directly. Therefore it can be a kind of useful analysis method for discriminating true BSR, which might arise from an Possion ratio contrast between high velocity layer, partially hydrated sediment and low velocity layer, water saturated gas sediment. During the AVO interpretation, as the AVO response can be changed depend upon the water saturation ratio, it is confused to discriminate the AVO response of gas layer from dry layer. In that case, the AVO modeling is necessary to generate synthetic seismogram comparing with real data. It can be available to make conclusions from correspondence or lack of correspondence between the two seismograms. AVO inversion process is the method for driving a geological model by iterative operation that the result ing synthetic seismogram matches to real data seismogram wi thin some tolerance level. AVO inversion is a topic of current research and for now there is no general consensus on how the process should be done or even whether is valid for standard seismic data. Unfortunately, there are no well log data acquired from gas hydrate exploration area in Korea. Instead of that data, well log data and seismic data acquired from gas sand area located nearby the gas hydrate exploration area is used to AVO analysis, As the results of AVO modeling, type III AVO anomaly confirmed on the gas sand layer. The Castagna's equation constant value for estimating the S-wave velocity are evaluated as A=0.86190, B=-3845.14431 respectively and water saturation ratio is $50\%$. To calculate the reflection coefficient of synthetic seismogram, the Zoeppritz equation is used. For AVO inversion process, the dataset provided by Hampson-Rushell CO. is used.
In order to estimate the hydrocarbon reserves, the porosity of the reservoir must be determined. The porosity of the area without a well is generally calculated by extrapolating the porosity logs measured at wells. However, if not only well logs but also seismic data exist on the same site, the more accurate pseudo porosity log can be obtained through artificial neural network technique by extracting the relations between the seismic data and well logs at the site. In this study, we have developed a module which creates pseudo porosity logs by using the polynomial neural network method. In order to obtain more accurate pseudo porosity logs, we selected the seismic attributes which have high correlation values in the correlation analysis between the seismic attributes and the porosity logs. Through the training procedure between selected seismic attributes and well logs, our module produces the correlation weights which can be used to generate the pseudo porosity log in the well free area. To verify the reliability and the applicability of the developed module, we have applied the module to the field data acquired from F3 Block in the North Sea and compared the results to those from the probabilistic neural network method in a commercial program. We could confirm the reliability of our module because both results showed similar trend. Moreover, since the pseudo porosity logs from polynomial neural network method are closer to the true porosity logs at the wells than those from probabilistic method, we concluded that the polynomial neural network method is effective for the data sets with insufficient wells such as F3 Block in the North Sea.
Jo, Jun-Han;Han, Jong-Hyeon;Kim, Seong-Ho;Lee, Byeong-Saeng
Journal of Korean Society of Transportation
/
v.24
no.6
s.92
/
pp.33-43
/
2006
This research is to the selection of optimal probability distribution as well as the estimation for design hourly factor in consideration of traffic characteristic, such as road function, lane number and AADT. To accomplish the objectives, we are applied to various probability distribution using traffic data that observed at permanent traffic count points in 2005. The parameters or the selected 14 probability distribution were estimated based on the method of maximum likelihood and the validity condition of the estimated parameter The goodness-of-fit test, such as chi-square test. was performed as well as the estimation of design hourly factor. As a result, An appropriate distributions of each case were selected : Pearson V for two lane of rural roads, LogLogistic for the four lane of rural roads, LogLogistic for the urban roads, Extreme value for recreation roads. And optimal K factor are as following : $0.1{\sim}0.2 $ for two lane of rural roads, $0.09{\sim}0.14$ for the four lane of rural roads. $0.07{\sim}0.13$ for the urban roads, $0.1{\sim}0.2$ for recreation roads.
Journal of the Korean Society of Food Science and Nutrition
/
v.18
no.4
/
pp.398-402
/
1989
Moisture sorption and cooking properties of two varieties of Korean soybean(Jangyup and Whangkeum) were studied. When soybean was stored under the various relative humidities (RH) of 33-86% at 16'E for 125hours, its sorption behaviors were divided into two : desorption at the RHs of 33 and 44% and adsorption at the RHs of above 55%. The sorption rate was decreased rapidly during storage. In comparisons with only storage humidities, the sample stored at higher RH held the higher sorption rate. The relationships between storage time and sorption rate were applied well to the equation, log dw/dt= b log t+ log a, where w is the moisture content(%, db), t is time(hour) and a and b are the parameters which were calculated from the experimental data. The calculated moisture contents from the equation agreed well with the measured moisture contents. On the other hand, the cooking degrees of soybean which was steamed in an autoclave at $106-121^{\circ}C$ were compared by the maximum cutting forces. The cooking time to attain the same degree of cooking decreased logarithmically as the cooking temperature increased. The z-values which were calculated from the time-temperature combinations that gave the same degree of cooking for Jangyup and Whangkeum were $13.3^{\circ}C$ and $12.8^{\circ}C$ respectively.
Five parameters such as the entrance size of the front wall, conduit size, wave period, wave height and the width of water pool were selected to estimate the inflow rate, which is basic and essential input data to design seawater exchange breakwater with a submerged mound by conducting hydraulic model experiments. In the results of multiple regression analysis, log-log equation showed a good agreement rather than linear equation and the estimation of inflow rate was well done with only two parameters except entrance size of the front wall, wave period and the width of water pool. Finally, non-dimensional flow rate equation is derived.
Purpose - This study measures how competitive securities broker-dealers are in the Korean financial markets. It aims to test whether the markets are perfectly competitive or monopolistic since the global financial crisis of 2008. Research design, data, and methodology - We apply the method developed by Panzar and Rosse (1987), H-statistics, which offers an index for the competitiveness as well as statistical tests. The dataset in use is retrieved mainly from the quarterly statements of the financial services companies by the Financial Statistics Information System of the Financial Supervisory Service. General information on officers and employees is utilized in addition to balance sheets and income statements of securities companies. Results - H-statistics for 2009-2015 is about 0.7 that is a robust estimate regardless of model specifications such as full trans-log, partial trans-log, and Cobb-Douglas regression equations. H-statistics for each year is also computed in similar ways in that it varies between 0.3 and 0.9. Conclusions - Since the global financial crisis, H-statistics concludes that securities broker-dealer markets in Korea is neither perfectly competitive nor monopolistic. It evidences that the markets are rather monopolistically competitive. The trend in annual H-statistics leads to the same conclusion but the result is not such stable that overall H-statistics implies.
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