• Korean Journal of Veterinary Research
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• v.34 no.2
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• pp.259-266
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• 1994

The study was carried out to determine the pharmacokinetic parameters after intravenous(iv) and intramuscular(im) administration (10mg/kr) in healthy rabbits. The results obtained through the experiments were summarized as follows: 1. Bioassay (Bacillus cereus 11778) was evaluated very useful for the determination of oxytetracycline(OTC) in the rabbit serum and tissues, with the detection limit of $0.125{\mu}g/ml$. 2. The pharmacokinetic profiles of OTC (10mg/kg, iv) in rabbits were best described with a two compartment open model $(C=29.5e^{-4,3t}{\pm}3.6^{-0.2t})$, whereas that of OTC (10mg/kg, im) showed a one compartment curve fitting. 3. Following iv administration, a rapid distribution phase was predominant [$t_{\frac{1}{2}}({\alpha}):1.43{\pm}0.98hr$ (♂), $0.5{\pm}0.1hr$(♀)], and then more slow elimination phase ensued [$t_{\frac{1}{2}}({\beta}):4.52{\pm}0.76hr$(♂), $7.32{\pm}2.52hr$(♀)]. Other computer generated pharmacokinetic values were as follows:C1 [$67.76{\pm}18.59ml/kg/h$(♂), $76.03{\pm}22.98ml/kg/h$ (♀)] Vd [$257.74{\pm}180.47ml/kg$ (♂), $92.33{\pm}23.62$ (♀)] AUC [$25.6{\pm}4.44mgh/L$ (♂), $39.6{\pm}12.13mgh/l$ (♀)]. There were no statistical significance between both sexes for all the parameters at the confidence level of 95%. 4. After im administaration, the absorption from the injection sites was very rapid [ Ka:$0.18{\pm}0.03h^{-1}$ (♂), $0.24{\pm}0.02h^{-1}$ (♀)] followed by a monoexponential elimination fashion. The time to peak blood level (Tmax) were calculated $1.64{\pm}0.15hr$ and $1.34{\pm}0.24hr$, in the male and female, respectively. The peak levels (Cmax) at the corresponding time were $1.69{\pm}0.23{\mu}g/ml$ (♂) and $2.08{\pm}0.16{\mu}g/ml$ (♀), with no statistical differences (p>0.05).

• The Korean Journal of Nuclear Medicine Technology
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• v.12 no.3
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• pp.192-198
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• 2008

Purpose: The scan time reduction helps to yield more accurate results and induce the minimization of patient's motion. Also we can expect that satisfaction of examination will increase. Nowdays medical equipment companies have developed various programs to reduce scan time. We used Onco. Flash (Pixon method, SIEMENS) that is an image processing technique gated cardiac blood pool scan and going to evaluate its clinical usefullness. Materials and Method: We analyzed the 50 patients who were examined by gated blood pool scan in nuclear medicine department of Asan Mediacal Center from June $20^{th}$ 2008 to August $14^{th}$ 2008. We acquired the Full-time (6000 Kcounts) and Half-time (3000 Kcounts) LAO image in same position. And we acquired LVEF values ten times from Full-time, Half-time images acquired by the image processing technique and analyzed its mean and standard deviation values. To estimate LVEF in same conditions, we set automatic location of the LV ROI and background ROI based on same X and Y-axis. Also we performed blinding tests to physician. Results: After making a quantitative analysis of the 50 patients EF values, each mean${\pm}$standard deviation is shown at Full-time image $68.12{\pm}7.84%$, Half- time (acquired by imaging processing technique) $68.49{\pm}8.73%$. In the 95% confidence limit, there was no statistically significant difference (p>0.05). After blinding test with a physician for making a qualitative analysis, there was no difference between Full-time image and Half-time image acquired by the image processing technique for observing LV myocardial wall motion. Conclusion: Gated cardiac blood pool scan has been reported its relatively exact EF measured results than ultrasound or CT. But gated cardiac blood pool scan takes relatively longer time than other exams and now it needs to improve time competitive power. If we adapt Half-time technique to gated cardiac blood pool scintigraphy based on this study, we expect to reduce possible artifacts and improve accessibility as well as flexibility to exam. Also we expect patient's satisfaction.

• Journal of Pharmaceutical Investigation
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• v.37 no.5
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• pp.315-321
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• 2007

The purpose of the present study was to evaluate the bioequivalence of two lercanidipine hydrochloride tablets, Zanidip tablet (LG Life Sciences Ltd., Korea, reference drug) and Samchundang Lercanidipine tablet 10 mg (Sam Chun Dang Pharm. Co. Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (amlodipine maleate) to human serum, serum samples were extracted using hexan-isoamyl alcohol (100:1, v/v). Compounds were analyzed by liquid chromatography/tandem mass spectrometry. This method showed linear response over the concentration range of 0.05-20 ng/mL with correlation coefficient of 0.9999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ng/mL which was sensitive enough for pharmacokinetic studies. Thirty healthy male Korean volunteers received each medicine at the lercanidipine hydrochloride dose of 20 mg in a $2\;{\times}\;2$ crossover study. There was a one-week washout period between the doses. Serum concentrations of lercanidipine were monitored by an LC/MS/MS fer over a period of 24 hr after the administration. $AUC_t$ (the area under the serum concentration-time curve from time 0 to 24 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (the maximum serum drug concentration) and $T_{max}$ (the time to reach $C_{max}$) were compiled from the serum 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 Samchundang Lercanidipine/Zanidip were log 0.9505-log 1.2258 and log 0.9987-log 1.2013, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Samchundang Lercanidipine tablet 10 mg and Zanidip tablet are bioequivalent.

• Journal of Pharmaceutical Investigation
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• v.40 no.2
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• pp.109-115
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• 2010

The purpose of the present study was to evaluate the bioequivalence of two choline alphoscerate soft capsules, Gliatilin soft capsule (Daewoong Pharmaceuticals Co., Ltd.) and Cholicerin soft capsule (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Serum concentrations of choline after oral administration of choline alphoscerate were determined using a validated LC/MS/MS method. This method showed linear response over the concentration range of 0.5-20 ${\mu}g$/mL with correlation coefficient of 0.9999. The lower limit of quantitation using 100 ${\mu}L$ of serum was 0.5 ${\mu}g$/mL which was sensitive enough for pharmacokinetic studies. Thirty six healthy male Korean volunteers received each medicine at the choline alphoscerate dose of 1200 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Blood samples were taken at predetermined time intervals up to 8 hr. $AUC_t$ (the area under the serum concentration-time curve from time 0 to 8 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (the maximum serum drug concentration) and $T_{max}$ (the time to reach $C_{max}$) were compiled from the serum 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 Cholicerin/Gliatilin were log0.9998-log1.1172 and log0.9938-1.0944, respectively. These values were within the acceptable bioequivalence intervals of log0.80-log1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Cholicerin soft capsule and Gliatilin soft capsule are bioequivalent.

• Korean Journal of Food Science and Technology
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• v.42 no.5
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• pp.541-548
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• 2010

In this study, contamination levels of 7 N-nitrosamine were investigated in processed meat products (n=51), processed fish products (n=62), salted fish pickles (n=20), and beer and malt beverages (n=21) using a GC/PCI-MS/MS method. The limits of detection (LOD) of the N-nitrosamines ranged from 0.2 to 0.5 ${\mu}g$/kg. In addition, methods were used to estimate the recovery of 7 N-nitrosamines, which ranged from 84 to 112%. N-nitrosamines were detected in 89 (58%) out of 154 samples. The exposure of an entire population group to N-nitrosamines through food intake was estimated using the average body weight of the total population and average daily food consumption, to perform risk assessment based on reports of a national health and nutrition survey. The results indicated that the daily intake of N-nitrosamines over a life time was $4.92{\times}10^{-7}$ mg/kg b.w./day. The margin of exposure (MOE) for the general population, estimated using the benchmark dose lower confidence limit 10 ($BMDL_{10}$) of N-nitrosodimethylamine, was 208,939, which was found to be safe.

• Journal of the Korea institute for structural maintenance and inspection
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• v.17 no.6
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• pp.130-137
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• 2013

This research was performed through the experimental design to get the statistical analysis on foamed concrete mixed plaster with hydrogen peroxide. In this experiment, we set the ratio of each material, which part of lightweight concrete, as experimental factors and evaluated on the mechanical properties by statistical analysis for response variables obtained from experiments. Experimental factors are plaster replacement, water binder ratio, and hydrogen peroxide ratio. Response variables are dry density, compressive strength, and flexural strength. Mixing design of the foamed concrete set up a total of 15 experimental points by Box-Behnken (BB) method of the response surface analysis. Thus, the results of a study were summarized as follows. Values of the probability in experimental factors (plaster replacement, water binder ratio and hydrogen peroxide ratio) on the response variables were estimated to be significant at the 95% of confidence limit. On response surface analysis for dry density of foamed concrete, water binder ratio and hydrogen peroxide ratio were estimated to be significant (${\alpha}$ = 0.05), and the relationship between the amount of void and the water content for dry density is inverse proportional. On response surface analysis for the compressive strength of foamed concrete, water binder ratio, hydrogen peroxide ratio and (hydrogen peroxide ratio)$^2$ was estimated to be significant (${\alpha}$ = 0.05). On response surface analysis for the flexural strength of foamed concrete, water binder ratio, hydrogen peroxide ratio was estimated to be significant (${\alpha}$ = 0.05). Through multi response surface analysis, we found the optimal area that meets performance goals.

• Journal of Life Science
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• v.14 no.4
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• pp.547-552
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• 2004

The present study was carried out to investigate the potential acute toxicity of amitraz by a single subcutaneous dose in beagle dogs. The test chemical was administered subcutaneously to male beagle dogs at dose levels of 0, 2, 10, or 50 mg/kg. Mortalities, clinical findings, and body weight changes were monitored for the 14-day period following the administration. At the end of 14-day observation period, hematology, serum biochemistry, and gross postmortem examinations were examined. A single dog in the 50 mg/kg group was found dead on day 3 after treatment and the other two dogs in the group were sacrificed because of the severe clinical signs on day 7 after treatment. Treatment related clinical signs, including anorexia, edema, mass and abscess formation in the injection sites, depression, vomiting, lacrimation, decreased locomotor activity, ataxia, recumbency, paresis in the limbs, and/or moribundity were observed in all treatment groups in a dose-dependent manner. Decreased or suppressed body weight gain was also observed dose-dependently in all treated groups. In autopsy, dead animals in the 50 mg/kg group showed muscular hemorrhage and inflammation in the injection sites and congestion in the liver and kidney. The terminal sacrificed animals in the 10 mg/kg group also exhibited muscular hemorrhage and inflammation in the injection sites. Whereas, no treatment related effects on hematology and serum biochemistry were observed on day 14 after treatment at any dose tested. On the basis of the results, it was concluded that a single subcutaneous injection of amitraz to beagle dogs resulted in increased incidence of abnormal clinical signs and death, decreased body weight, and increased incidence of abnormal gross findings. In the experimental conditions, the $LD_{50}$value of amitraz was 22.3 mg/kg (95% confidence limit not specified) and the no-observed-adverse-effect level (NOAEL) was considered to be below 2 mg/kg for male dogs.

• Journal of Pharmaceutical Investigation
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• v.36 no.5
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• pp.343-348
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• 2006

The purpose of the present study was to evaluate the bioequivalence of two zolpidem tartrate tablets, Stilnox tablet(Sanofi-aventis Korea, reference product) and Zanilo tablet(ChoDang Pharm Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration(KFDA). After adding an internal standard(cimetropium), 250 ${\mu}L$ plasma samples were extracted using 1.3 mL of ethyl acetate. Extracted compounds were analyzed by HPLC with triple-quadrupole mass spectrometry. This method for determination of zolpidem is proved accurate and reproducible with the limit of quantitation of 1 ng/mL in human plasma. Twenty-four healthy male Korean volunteers received each medicine at the zolpidem tartrate dose of 10 mg in a $2{\times}2$ crossover study. There was one-week washout period between the doses. Plasma concentrations of zolpidem were monitored for over a period of 8 hr after the administration. $AUC_{0-t}$(the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$(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 $AUC_{0-t}$ and $C_{max}$. No significant sequence effect was found for all of the bio-availability parameters indicating that the crossover design was properly performed. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25(e.g., log 0.92-log 1.06 for $AUC_{0-t}$, log 0.96-log 1.13 for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zanilo tablet is bioequivalent to Stilnox tablet.

• Journal of Applied Biological Chemistry
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• v.63 no.3
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• pp.267-274
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• 2020

The dissipation characteristics and kinetics of fungicide mandipropamid and insecticide thiamethoxam in lettuce under greenhouse conditions were investigated at three different lettuce-growing fields for estimating the pre-harvest residue limits (PHRLs). The analytical methods were fully validated for the quantitation of pesticide residues using High-Performance Liquid Chromatography-Photo Diode Array detector or Ultraviolet-Visible Detector and applied to real samples. The lettuces suitable for shipment were harvested during 10 days including pre-harvest interval after treatment at the recommended dose by safe-use guidelines. The initial mean residues in different fields were 6.68-17.87 and 4.96-8.31 mg/kg for mandipropamid and thiamethoxam, respectively, which decreased to 16-54 and 14-44% in 10 days. The clothianidin, a metabolite of thiamethoxam, was detected in <0.02 to 0.37 mg/kg. The dissipation of both pesticides followed first-order kinetics over a period of 10 days after application. Based on the residue data, the mean dissipation rate constant (λ) and biological half-lives (T_1/2) were estimated to be -0.1060 and 6.5 days of mandipropamid and -0.1236 and 5.6 days of thiamethoxam. The PHRLs for lettuce on the 10th and 5th day before harvesting were calculated to be 63.24 and 43.56 mg/kg for mandipropamid, and 44.66 and 25.88 mg/kg for thiamethoxam, with -0.0746 and -0.1091 of the upper 95% confidence intervals of dissipation rate constant, respectively. This work would be useful as guidance for adjusting the shipment date and contribute to stabilizing the income of farmers in Korea.

• The Korean Journal of Nuclear Medicine
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• v.21 no.2
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• pp.143-150
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• 1987

To assess the analytic performance of immunoradiometric TSH assay (IRMA TSH), assay precision determined by intra and interassay variance, assay accuracy determined by dilution and recovery study, were evaluated by using two commercial kit $(Abott^{(R)}\;and\;Daichi^{(R)})$. Normal range of basal serum TSH and TRH stimulated TSH increment were also determined in 234 healthy subjects (male 110, female 124; age 20-70) and 30 voluteers (male 10, female 20; age 21-26). In addition, basal TSH levels of 70 patients with untreated hyperthyroidism, 50 untreated hypothyroidism, and 60 euthyroidism were measured to assess the clinical utility of IRMA TSH. The detection limit of IRMA TSH was 0.04 mU/l and 0.08 mU/l by Abott Kit and Daichi kit respectively. Using Abott kit, intra assay variance were 2.0, 3.1 and 1.4% in mean TSH concentration 2.4, 31.6 and 98.2 mU/l repectively and interassay variance were 2.0 and 3.2% in mean TSH concentration 2.3 and 31.3 mU/l. Mean recovery rate was 92.5% and dilution study showed nearly straight line. When Daichi kit was used, intrasssay variance were 5.6, 5.2 and 6.2% in mean TSH concentration of 2.4, 31.6 and 98.2 mU/l respectively and interassay variance were 7.1 and 7.4% in mean TSH of 2.3 and 31.3 mU/l. Mean recoveray rate was 89.9%. Normal range of basal TSH and TRH stimulated peak TSH were 0.38-4.02 mU/l and 2.85-30.8 mU/l repectively (95% confidence interval, Abott kit used). Sensitivity and specificity of basal TSH levels for diagnosing hypothyroidism as well as specificity for diagnosing hyperthyroidism were 100% by using both kit. Sensitivity of basal TSH level for diagnosing hyperthyroidism was 100% when TSH levels were measured by Abott kit while that was 80.9% when measured by Daichi kit. These results suggest that IRMA TSH was very precise and accurate method and might be used as a first line test in the evaluation of thyroid function.