• Journal of Pharmaceutical Investigation
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• v.31 no.1
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• pp.49-55
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• 2001

Acetyl-L-carnitine (ALC), an endogenous component of the L-carnitine family, is naturally occurring molecule synthesized from L-carnitine (LC) by carnitine acetyl transferase. ALC has been shown to improve the cognitive performance of patients suffering from dementia of the Alzheimer's type and proposed for treating Alzheimer's disease in pharmacological doses. The purpose of the present study was to evaluate the bioequivalence of two ALC tablets, $Nicetile^{TM}$ (Dong-A pharmaceutical Co., Ltd.) and $Neurocetil^{TM}$ (Kyung-Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration. Twenty six normal male volunteers, $22.80{\pm}2.76$ year in age and $63.07{\pm}7.98\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 500 mg of ALC was orally administered, blood was taken at predetermined time intervals and the concentrations of ALC in serum were determined using HPLC with fluorescence detector. Because of the presence of endogenous ALC, the calibration was performed using dialyzed serum. Pharmacokinetic parameters such as $AUC_t$, $C_{max}\;and\;T_{max}$ were calculated and 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 two tablets were 2.72%, -0.65% and -8.42%, respectively, when calculated against the $Nicetile^{TM}$ tablet. The powers $(1-{\beta})$ for $AUC_t\;and\;C_{max}$ were 94.87% and 87.17%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 15.58% and 19.16% $AUC_t\;C_{max}$, respectively). The 90% confidence intervals were within ${\pm}20%$ (e.g., $-11.84{\sim}6.41$ and $-10.57{\sim}11.88$for $AUC_t\;and\;C_{max}$, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Neurocetil^{TM}$ tablet is bioequivalent to $Nicetile^{TM}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.31 no.1
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• pp.57-62
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• 2001

Azelastine, a phthalazinone derivative, is an antiallergic agent which demonstrates histamine $H_1-receptor$ antagonist activity and also inhibits histamine release from mast cells following antigen and non-antigen stimuli. Thus, azelastine may be useful in the management of both asthma and allergic disorders. The purpose of the present study was to evaluate the bioequivalence of two azelastine hydrochloride tablets, $Azeptin^{TM}$ (Bu Kwang Pharmaceutical Co., Ltd.) and $Azela^{TM}$ (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $22.44{\pm}2.01$ years in age and $61.99{\pm}6.18\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 1 mg of azelastine hydrochloride per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of azelastine in serum were determined using HPLC with fluorescence detector. 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. The results showed that the differences in $AUC_t$, $C_{max}\;and\;T_{max}$ between two tablets were -6.45%, -2.60% and -7.14%, respectively, when calculated against the $Azeptin^{TM}$ tablet. The powers $(1-{\beta})$ for $AUC_t\;and\;C_{max}$ were 96.65% and 88.47%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 14.40% and 17.65% for $AUC_t\;and\;C_{max}$, respectively). The 90% confidence intervals were within ${\pm}20%$ (e.g., $-14.87{\sim}1.97$ and $-12.92{\sim}7.72$ for $AUC_t\;and\;C_{max}$, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Azela^{TM]$ tablet is bioequivalent to $Azeptin^{TM}$ tablet.

• Analytical Science and Technology
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• v.23 no.5
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• pp.465-476
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• 2010

In this study, a number of volatile organic compounds (VOCs) including benzene, toluene, p-xylene, styrene, and methyl ethyl ketone were analyzed from samples collected in ambient air and under the field conditions. These samples were analyzed independently by two different set-ups for VOC analyses, i.e., between [1] gas chromatography/flame ionization detector with tube sampling - (F-T system) and [2] gas chromatography/mass spectrometer with bag sampling (M-B system). The analytical results derived by both systems showed fairly similar patterns in relative sense but with moderately large differences in absolute sense. The results of M-B system were high relative to F-T system with the F-T/M-B ratio below 1. If the relative biases of the two measurement techniques are derived in terms of percent difference (PD) in concentration values, the results were generally above 35% on average. A student t-test was applied to investigate the statistical significance of those differences between the systems. The results of both analytical systems were different at 95% confidence level for toluene, p-xylene, styrene, and methyl ethyl ketone (P < 0.043). However, F-T and M-B systems showed strong correlations for toluene and p-xylene. The observed bias is explained in large part by such factors as the differences in standard phases used for each system and the chemical loss inside the bag sampler.

• Journal of radiological science and technology
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• v.40 no.3
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• pp.493-499
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• 2017

In order to analyze the degree of self-learning development ability after the clinical training curriculum, the results of 121 questionnaires were analyzed for 3rd and 4th grade students in radiology in the metropolitan area. The overall average of self-learning ability according to gender was $3.07{\pm}0.85$, which was statistically significant according to gender. However, the results according to educational system showed that the overall average was $3.07{\pm}0.85$, which was higher than the average level of self-learning development ability. There was no statistically significant difference according to educational system. The results of the self-learning development ability according to the motivation for selecting the department showed that the students who have chosen their department due to their higher employment rate after graduation had high self-development ability level($3.58{\pm}0.85$) but the students who entered the school due to self-aptitude had relatively lower self-development ability level ($2.30{\pm}0.40$). The overall average of self-learning ability according to direction of career path was $3.08{\pm}0.76$, which was over-average of self-learning development ability. Thus, there was statistically significant difference according to career path. It is necessary to improve the self-learning ability in clinical practice. In addition, the lack of statistical significance suggests problems and diversity.

• Journal of radiological science and technology
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• v.40 no.1
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• pp.79-85
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• 2017

The purpose of this study was to measure contrast to noise ratio (CNR) and signal to noise ratio (SNR) according to change of reconstruction from region of interest (ROI) in breast positron emission tomography-computed tomography (PET-CT), and to analyze the CNR and SNR statically. We examined images of breast PET-CT of 100 patients in a University-affiliated hospital, Seoul, Korea. Each patient's image of breast PET-CT were calculated by using ImageJ. Differences of CNR and SNR among four reconstruction algorithms were tested by SPSS Statistics21 ANOVA test for there was statistical significance (p<0.05). We have analysis socio-demographical variables, CNR and SNR according to reconstruction images, 95% confidence according to CNR and SNR of reconstruction and difference in a mean of CNR and SNR. SNR results, with the quality of distributions in the order of PSF_TOF, Iterative and Iterative-TOF, FBP-TOF. CNR, with the quality of distributions in the order of PSF_TOF, Iterative and Iterative-TOF, FBP-TOF. CNR and SNR of PET-CT reconstruction methods of the breast would be useful to evaluate breast diseases.

• Korean Journal of Food Science and Technology
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• v.35 no.6
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• pp.1053-1059
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• 2003

This study aimed to determine the amount of vitamin C from vegetable & fruit juice by high performance liquid chromatograhy (HPLC). Components for estimation of measurement uncertainty associated with the analysis of vitamin C, such as standard weight, purity, molecular weight, dilution of standard solution, calibration curve, recovery, and precision, were importantly applied. The estimation of uncertainty obtained with systematic and random error based on the GUM (Guide to the expression of uncertainty in measurement) and EURACHEM document with mathematical calculation and statistical analysis. The components, evaluated ty either Type A or Type B methods, were combined to produce an overall value of uncertainty known as the combined standard uncertainty. An expanded uncertainty was obtained by multiplying the combined standard uncertainty with a coverage factor (k) calculated from the effective degree of freedom. The content of vitamin C from vegetable and fruit juice was 27.53 mg/100g and the expanded uncertainty by multiplying by the coverage factor (k, 2.06) was 0.63 mg/100g at a 95% confidence level. It was concluded that the main sources were, in order of recovery and precision, weight and purity of the reference material, dilution of the standard solution, and calibration curve. Careful experiments on other higher uncertainties is further needed in addition to better personal proficiency in sample analysis in terms of accuracy and precision.

• Journal of Pharmaceutical Investigation
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• v.31 no.4
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• pp.281-287
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• 2001

Rebamipide is a novel anti-gastric ulcer agent that has been reported to increase the synthesis of mucus, to increase the mucosal concentration of prostaglandin, and to promote rapid ulcer healing. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, $Mucosta^{TM}$ (Otsuka Korea Pharmaceutical Co., Ltd.) and $Rebamide^{TM}$ (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The rebamipide release from the two rebamipide tablets in vitro was tested using KP VII Apparatus II method at pH 6.8 dissolution media. Twenty normal male volunteers, $24.20{\pm}2.26$ years in age and $66.19{\pm}9.41\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 100 mg of rebamipide was orally administered, blood was taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two rebamipide tablets were very similar at pH 6.8 dissolution media. Besides, 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. The results showed that the differences in $AUC_t$, $C_{max}\;and\;T_{max}$ between two tablets based on the $Mucosta^{TM}$ were -2.57%, 5.77% and -1.47%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 12.62% and 17.63% for $AUC_t,\;and\;C_{max}$, respectively). The powers $(1-{\beta})$ at ${\alpha}=0.05$, ${\Delta}=0.2$ for $AUC_t\;and\;C_{max}$ were above 99.00% and 88.56%, respectively. The 90% confidence intervals were within ${\pm}20%$ (e.g., $-9.96{\sim}4.82$ and $-4.54{\sim}16.09$ for $AUC_t\;and\;C_{max}$, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Rebamide^{TM}$ tablet is bioequivalent to $Mucosta^{TM}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.30 no.1
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• pp.61-65
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• 2000

Doxazosin, a postsynaptic selective ${\alpha}1-adrenoceptor$ antagonist, is a potent antihypertensive agent which reduces peripheral resistance and blood pressure by vasodilatation of peripheral vessels. It is also used in the treatment of urinary obstruction by benign prostatic hypertrophy. The purpose of the present study was to evaluate the bioequivalence of two doxazosin tablets, $Cardura^{TM}$ (Pfizer Korea Ltd.) and $Cardil^{TM};$ (Kyungdong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers, $24.19{\pm}2.48$ years in age and $62.41{\pm}6.66$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 2 mg of doxazosin was orally administered, blood was taken at predetermined time intervals and the concentrations of doxazosin in serum were determined with an HPLC method using spectrofluorometric detector. 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. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets were -1.54%, -1.51 % and 3.42%, respectively, when calculated against the $Cardura^{TM}$ tablet. The powers $(1-{\beta})$ for $AUC_t,\;C_{max}\;and\;T_{max}$ were all more than 99.00%. Minimum detectable differences $(\Delta)$ at ${\alpha}=0.05\;and\;1-{\beta}=0.8$ were all less than 20% (e.g., 12.73%, 12.84% and 13.01% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively). The 90% confidence intervals were all within :${\pm}20%$ (e.g., $-8.97{\sim}5.90,\;-9.01{\sim}6.00\;and\;-4.16{\sim}11.05\;for\;AUC_t,\;C_{max}\;and\;T_{max},\;respectively)$. All of the above para- meters met the criteria of KFDA for bioequivalence, indicating that $Cardil^{TM}$ tablet is bioequivalent to $Cardura^{TM}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.40 no.2
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• pp.117-123
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• 2010

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.

• Korean Journal of Clinical Laboratory Science
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• v.36 no.1
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• pp.19-26
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• 2004

According to increase of domestic blood components use, the quality control of blood components is necessary to support good products. The purpose of this study is used to provide the producing index of the good product as compared with the accuracy and validity for the distribution of the quality control data. The value of mean, standard deviation, 95% confidence interval and degree of normal distribution of data were calculated by univariate procedure, the value of monthly mean of each blood centers per items were compared by Analysis of Variance(ANOVA) test for the degree of distribution. When there was difference among the mean values, the Duncan's multiple range test was done to confirm the difference. Finally, methods for accessing accuracy and validity of the quality data was done by the Contingency table test. The quality data of five blood centers was showed to the normal distribution and it was in a acceptable range. For each blood centers, the monthly means of Hematocrit(Hct), Platelet(PLT) and pH were not significantly different except Hct of C center, PLT of B, D center and pH of A center. The quality data per items was graded according to quality to six level. As a result of the comparative analysis, the monthly means of Hct of C and E center was significantly different higher than that of D, B and A center. The monthly means of PLT of A center and pH of C center was significantly different higher than that of the others. In the accuracy and validity of the quality control data, C center for Hct, A center for PLT and C center for pH were better than the other. The C blood center was most satisfiable and stable in the quality control for blood component. If the quality control method used in C blood center is adopted in other blood centers, the prepared level of the blood component of the center will be improved partly.