• Journal of Pharmaceutical Investigation
• /
• v.32 no.2
• /
• pp.135-140
• /
• 2002

Cefadroxil is a semi-synthetic cephalosporin active against many Gram-positive and Gram-negative bacteria. The drug has been used for the treatment of the urinary and respiratory tract infections when caused by susceptible strains of the designated microorganism. The purpose of the present study was to evaluate the bioequivalence of two cefadroxil capsules, Duricef (Bo Ryung Pharmaceutical Co. Ltd.) and Hanacef (Korean Pharmaceutical Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cefadroxil release from the two cefadroxil capsules in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four normal male volunteers, $21.58{\pm}2.43$ years in age and $70.74{\pm}10.29$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 500 mg as cefadroxil was orally administered, blood was taken at predetermined time intervals and the concentrations of cefadroxil in serum were determined using HPLC with UV detector. The dissolution profiles of two cefadroxil capsules were very similar at all dissolution media. 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 $AUC_t\;and\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two capsules based on the Duricef were 0.05%, -5.29% and 4.53%. There were no sequence effects between two capsules in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) $(e.g.,\;log(0.95){\sim}log(1.05)\;and\;log(0.87){\sim}log(1.02)$ for $AUC_t\;and\;C_{max}$, respectively). The 90% confidence interval using untransformed data was within ${pm}20%$ $(e.g.,\;-6.75{\sim}15.74\;for\;T_{max})$. All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Hanacef capsule is bioequivalent to Duricef capsule.

• Journal of Pharmaceutical Investigation
• /
• v.34 no.3
• /
• pp.215-222
• /
• 2004

The purpose of the present study was designed to evaluate the bioequivalence of two oxiracetam tablets, Neuromed tablet (Korea Drug Co., reference drug) and Neuracetam tablet (Sam Jin Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Release of oxiracetam from the tablet in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty-four healthy volunteers, $23.7\;{\pm}\;2.4$ year in age and $68.9\;{\pm}\;6.2$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was performed. After oral administration of a tablet containing 800 mg of oxiracetam, blood samples were taken at predetermined time intervals and concentrations of oxiracetam in plasma were determined using HPLC-MS-MS. The dissolution profiles of two formulations were very similar at all dissolution media. In addition, 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 $AUC_t$ and $C_{max}$ untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug were 0.42%, 0.45% and -12.58% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log0.94{\sim}log1.06$ and $log0.90{\sim}log1.07$ for $AUC_t$, and $C_{max}$, respectively), indicating that Neuracetam tablet is bioequivalent to Neuromed tablet. The major pharmacokinetic parameters, $AUC_t$, and $C_{max}$ met the criteria set by KFDA for bioequivalence indicating that Neuracetam tablet is bioequivalent to Neuromed tablet.

• Proceedings of the Korea Contents Association Conference
• /
• 2008.05a
• /
• pp.274-280
• /
• 2008

The study of subjects were 8 persons. The study measured VO2max of each person and substituted METs at exercise intensity of both VO2max 50% and VO2max 70% in accordance with energy consumption formula to set exercise time at energy consumption of both 300kcal and 600kcal. And, the study substituted inclination and rate at exercise intensity that was measured at preliminary test. T, B, NK cell varied depending upon aerobic exercise to have no significant difference of exercise intensity at relative ratio of T, B, NK lymphocyte of all of lymphocytes and to have significant difference of Expenditures Calorie (p<.01) and interaction (p<.05) by T cell and Expenditures Calorie (p<.01) by B cell and Expenditures Calorie (p <.001) and interaction (p<.05) by NK cell.

• Journal of electromagnetic engineering and science
• /
• v.13 no.2
• /
• pp.127-133
• /
• 2013

We examined the scaling effects of a number of gate_fingers (N) and gate_widths (w) on the high-frequency characteristics of $0.1-{\mu}m$ metamorphic high-electron-mobility transistors. Functional relationships of the extracted small-signal parameters with total gate widths ($w_t$) of different N were proposed. The cut-off frequency ($f_T$) showed an almost independent relationship with $w_t$; however, the maximum frequency of oscillation ($f_{max}$) exhibited a strong functional relationship of gate-resistance ($R_g$) influenced by both N and $w_t$. A greater $w_t$ produced a higher $f_{max}$; but, to maximize $f_{max}$ at a given $w_t$, to increase N was more efficient than to increase the single gate_width.

• Fisheries and Aquatic Sciences
• /
• v.24 no.7
• /
• pp.235-242
• /
• 2021

The present study investigated the critical thermal maxima (CT_max) of red-spotted grouper, Epinephelus akaara under different acclimation temperatures (T_acc). Fish were acclimated at 24℃, 28℃, and 32℃ water temperature for 2 weeks. Water temperature was increased at a rate of 1℃/h and CT_max level was measured following the critical thermal methodology (Paladino et al., 1980). The results showed that CT_max values of E. akaara were 35.61℃, 36.83℃, and 37.65℃ for fish acclimated at 24℃, 28℃, and 32℃, respectively. The acclimation response ratio (ARR) was 0.26. The CT_max values were significantly correlated with body size. Collectively, it is said that the CT_max value of red-spotted grouper can be affected by different adaptation temperature (24℃, 28℃, and 32℃) and the fish acclimated to a higher temperature has a higher CT_max level. Besides, the CT_max value of 35.61℃-37.65℃ indicating the upper thermal tolerance limit for E. akaara under different T_acc (24℃, 28℃, and 32℃). Understanding the thermal tolerance of E. akaara is of ecological importance in the conservation of this species.

• Environmental Mutagens and Carcinogens
• /
• v.21 no.1
• /
• pp.1-8
• /
• 2001

We have synthesized $^{99m}$Tc-mercaptoacetyltriglycine (MAG3)-biocytin as a new imaging agent for hepatobiliary scintigraphy. The aim of this study was to evaluate the usefulness of $^{99m}$Tc-MAG3-biocytin scintigraphy in differentiating carbon tetrachloride ( $CCl_4$)-induced hepatotoxicity from $\alpha$-naphthylisothiocyanate (ANIT)-induced cholestasis in mice, which reflecting the differential diagnosis of neonatal jaundice caused by neonatal hepatitis from congenital biliary atresia in humans. Methods: Balb/c mice (female, 20 g, n=4-6) were pretreated with $CCl_4$(0.5 or $1.0m\ell$/kg) and ANIT ($150 or 300 m\ell$/kg) 18 h before scintigraphy. Biochemical and histopathological examinations showed a pattern of typical acute hepatitis (increase of transaminases and hepatocellular necnsis) in $CCl_4$-treated mice and cholestasis (increase of alkaline phosphatase and ${\gamma}$-glutamyltransferase, and biliary hyperplasia) in ANIT-treated mice, respectively, Mice were fasted at least 4 hr prior to the intravenous injection of $^{99m}$Tc-MAG3-biocytin (18.5 MBq/20$\mu\textrm{g}$) in 2% human serum albumin in saline. Scintigraphy was performed with a ${\gamma}$-camera equipped with a 1-mm diameter pin-hole collimator for 30 min and images were acquired every 15 s. We compared the values of physical parameters, such as peak liver/heart ratio ($${\gamma}$_{max}$) and peak ratio time ($t_{max}$) far $^{99m}$Tc-MAG3-biocytin scintigraphy. Results: Scintigraphic parameters of the $CCl_4$-pretreated (0.5 $m\ell$/kg) group showed a 81.9% decrease of r$_{max}$, and 42.2% decrease of $t_{max}$, whereas the ANIT-pretreated ( $150m\ell$/kg) group showed a 53% decrease of $r_{max}$, and 2.36-fold increase of $t_{max}$, (P<0.05). These results demonstrate that the decrease of $r_{max}$ and the shortening of $t_{max}$ are characteristic features for hepatotoxicity, in contrast to the increase of $t_{max}$ and decrease of $r_{max}$ for biliary hyperplasia. Conclusion: $^{99m}$Tc-MAG3-biocytin hepatobiliary scintigraphy can distinguish hepatitis from cholestasis in mice model and may be similarly useful in humans which differentiating the cause of neonatal jaundice in clinical study.cal study.cal study.cal study.

• Biomolecules & Therapeutics
• /
• v.15 no.3
• /
• pp.187-191
• /
• 2007

This study was conducted to compare the bioavailability of two brands of atenolol (50 mg) tablets, which are a generic product of $Ditent^{\circledR}$ (Daewon Pharmaceutical Co., Ltd., Korea) and an innovator product $Tenormin^{\circledR}$ (Hyundai Pharm. Ind. Co., Ltd., Korea), in 20 healthy Korean male volunteers. The volunteers received a single 50 mg dose of each atenolol formulation according to a randomized, two-way cross-over design. The washout period between treatments was 1 week. Plasma samples were obtained over a 24-hour interval, and atenolol concentrations were determined by HPLC with a fluorescence detector. From the plasma atenolol concentration vs. time curves, the following parameters were compared: area under the plasma concentration-time curve ($AUC_{0-24}$), peak plasma concentration ($C_{max}$), time to reach peak plasma concentration ($T_{max}$), and terminal first order elimination half-life ($t_{1/2}$). No statistically significant difference was obtained between the $T_{max}$ values, and the logarithmic transformed $AUC_{0-24}$ and $C_{max}$ values of the two products. The 90% confidence interval for the ratio of the logarithmically transformed AUC and $C_{max}$ values of $Ditent^{\circledR}$ over those of $Tenormin^{\circledR}$ were calculated to be between 0.85 and 1.04, and 0.89 and 1.07, respectively; both were within the bioequivalence limit of 0.80-1.25. The mean of $T_{max}$ in $Tenormin^{\circledR}$ group was 3.1 hour, and that in Ditent$^{\circledR}$ group was 3.2 hour. The values of $t_{1/2}$ between the two products were found comparable, and the mean values were 5.2 hour in the both products. Based on these results, it was concluded that $Ditent^{\circledR}$ was comparable to $Tenormin^{\circledR}$ in both the rate and extent of absorption, indicating that $Ditent^{\circledR}$ was bioequivalent to the reference product, $Tenormin^{\circledR}$.

• Journal of Pharmaceutical Investigation
• /
• v.32 no.2
• /
• pp.119-125
• /
• 2002

A rapid, selective and reproducible high-performance liquid chromatographic method has been developed for the determination of terazocin in human plasma. Terazocin plus the internal standard, prazocin hydrochloride, were extracted from alkalified plasma with tert-butylmethyl ether, back-extracted into 0.05% phosphoric acid. Fifty ${\mu}l-portions$ of extract were injected onto a octadecylsilane column and eluted with a mixture of acetonitrile, water and triethylamine (30 : 70 : 0.1 v/v, adjusted to pH 5.0 with dilute phosphoric acid) at a flow rate of 1.0 ml/min. The fluorescence intensity of column eluents was monitored at excitation wavelength of 250 nm and emission wavelength of 370 nm. No interference peaks were observed. The practical limit of quantitation was 5 ng/ml for terazocin. The average intraday and interday coefficients of variation were 4.15 and 3.54%, respectively. Also intraday and interday precisions over the range $5{\sim}60\;ng/ml$ were $0.49{\sim}2.92\;and\;0.38{\sim}5.12%$, respectively. The bioequivalence of two terazosin tablets, the $Hytrine^{\circledR}$ (Il Yang Pharmaceutical Co., Ltd.) and the $Teratonin^{\circledR}$ (Sam-A Pharmaceutical Co., Ltd.), was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers $(24.6{\pm}2.0\;years\;old)$ were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 2 mg of terazosin was orally administered, blood was taken at predetermined time intervals and the concentration of terazosin in plasma was determined with a HPLC method using spectrofluorometric detector. AUC was calculated by the linear trapezoidal method. $C_{max}\;and\;T_{max}$ were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between the two preparations were 0.21 %, 5.53% and 8.82%, respectively. The powers $(1-{\beta})\;for\;AUC_t,\;C_{max}\;and\;T_{max}$ were >99%, 97.49%, and 33.26%, respectively. Minimum detectable differences $({\Delta},\;%)\;at\;{\alpha}=0.1\;and\;1-{\beta}=0.8$ and the 90% confidence intervals were all less than ${\pm}20%$ except for $T_{max}.\;AUC_t\;and\;C_{max}$ met the criteria of KDFA for bioequivalence, indicating that $Teratonin^{circledR}$ tablets are bioequivalent to $Hytrine^{circledR}$ tablets.

• The Korean Journal of Nuclear Medicine Technology
• /
• v.23 no.1
• /
• pp.69-74
• /
• 2019

Purpose $^{18}F$-FDOPA using amino acid is particularly attractive for imaging of brain tumors because of the high uptake in tumor tissue and the low uptake in normal brain tissue. But, on the other hand, $^{18}F$-FDG is highly uptake in both tumor tissue and normal brain tissue. The purpose of study is to evaluate comparison of contrasts in $^{18}F$-FDOPA Brain PET/CT and $^{18}F$-FDG Brain PET/CT and to find out optimal scan time by analysis of variation in SUV with the passage of uptake time. Materials and Methods A region of interest of approximately $350mm^2$ at the center of the tumor and cerebellum in 12 patients ($51.4{\pm}12.8yrs$) who $^{18}F$-FDG Brain PET/CT and $^{18}F$-FDOPA Brain PET/CT were examined more than once each. The $SUV_{max}$ was measured, and the $SUV_{max}$ ratio (T/C ratio) of the tumor cerebellum was calculated. In the analysis of SUV, T/C ratio was calculated for each frame after dividing into 15 frames of 2 minutes each using List mode data in 25 patients ($49.{\pm}10.3yrs$). SPSS 21 was used to compare T/C ratio of $^{18}F$-FDOPA and T/C ratio of $^{18}F$-FDG. Results The T/C ratio of $^{18}F$-FDOPA Brain PET/CT was higher than the T/C ratio of $^{18}F$-FDG Brain, and show a significant difference according to a paired t-test(t=-5.214, p=0.000). As a result of analyzing changes in $SUV_{max}$ and T/C ratio, the peak point of $SUV_{max}$ was $5.6{\pm}2.9$ and appeared in the fourth frame (6 to 8 minutes), and the peak of T/C ratio also appeared in the fourth frame (6 to 8 minutes). Taking this into consideration and comparing the existing 10 to 30 minutes image and 6 to 26 minutes image, the $SUV_{max}$ and T/C ratio increased by 0.2 and 0.1 each, compared to the 10 to 30 minutes image for 6 to 26 minutes image. Conclusion From this study, $^{18}F$-FDOPA Brain PET/CT is effective when reading the image, because the T/C ratio of $^{18}F$-FDOPA Brain PET/CT was higher than T/C ratio of $^{18}F$-FDG Brain PET/CT. In addition, in the case of $^{18}F$-FDOPA Brain PET/CT, there was no difference between the existing 10 to 30 minutes image and 6 to 26 minutes image. Through continuous research, we can find possibility of shortening examination time in $^{18}F$-FDOPA Brain PET/CT. Also, we can help physician to accurate reading using additional scan data.

• Journal of Oral Medicine and Pain
• /
• v.25 no.4
• /
• pp.345-353
• /
• 2000

This study was to investigate normal salivary flow rates and normal indices of Quantitative analysis of salivary scintigraphy. 96 adult volunteers were studied by Questionnaire evaluating salivary conditions and clinical examinations. 35(male 23, female 12, age range 23-31years) that absented subjective and objective symptoms related saliva were classified as normal group. The normal group underwent measurement unstimulated and stimulated salivary flow rates and salivary scintigraphy. The obtained results were as follows: 1. There were not significant in sex differences of unstimulated and stimulated salivary flow rates. The unstimulated salivary flow rate was $0.66{\pm}0.41g/min$, stimulated salivary flow rates was $1.61{\pm}0.69g/min$. 2. As comparing of parameters of salivary scintigraphy, the Uptake ratio(UR), $T_{max}$, $T_{min}$, Maximum accumulation (MA), Maximum secretion(MS) of parotid and submandibular glands were not significant in sex and side-ralated differences. 3. The UR, $T_{max}$, MA, MS of parotid gland were significantly higher than those of submandibular gland; in the parotid gland, UR, $3.67{\pm}0.88$, $T_{max}$, $18.77{\pm}0.43min$, MA, $41.35{\pm}9.22%$, MS, $43.13{\pm}9.13%$; in the submandibular gland, UR, $3.04{\pm}0.10$, $T_{max}$, $18.48{\pm}0.52min$, MA, $36.47{\pm}14.18%$, MS, $36.88{\pm}12.20%$. 4. As classifying of time-activity curve, the most of parotid gland was N-type(97.1%), submandibular gland was observed in order of M-type(67.1%), N-type(21.4%), F-type(11.4%), however, was not observed S-type. 5. As the type of time-activity curve of submandibular gland was more flattened, the UR, $T_{max}$, MA, MS were significantly decresed.