• Journal of Pharmaceutical Investigation
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• v.38 no.2
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• pp.135-142
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• 2008

The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor $Tablet^{(R)}$ (Pfizer, reference drug) and Atorva $Tablet^{(R)}$ (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a $2{\times}2$ crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were complied trom 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 crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Atorva $Tablet^{(R)}$ / Lipitor $Tablet^{(R)}$ were ${\log}\;0.9413{\sim}{\log}\;1.0179$ and ${\log}\;0.831{\sim}{\log}\;1.0569$, respectively. These values were within the acceptable bioequivalence intervals of ${\log}\;0.8{\sim}{\log}\;1.25$. Based on these statistical considerations, it was concluded that the test drug, Atorva $Tablet^{(R)}$ was bioequivalent to the reference drug, Lipitor $Tablet^{(R)}$.

• The Korea Journal of Herbology
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• v.28 no.3
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• pp.17-24
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• 2013

Objectives : This study was to evaluate the single dose toxicity of Persicae Semen (PS) in ICR mice. Methods : Aqueous extracts of PS (Yield = 18.60%) were administered as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) guidelines (2009-116, 2009). Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 12 principle organs were examined. Results : Amygdalin contents in PS aqueous extracts were detected as $32.50{\pm}5.96{\mu}g/ml$. We could not find any PS extracts treatment related mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations up to 2,000 mg/kg in both female and male mice, except for transient and slight loss of locomotion detected in female and male mice treated with 2,000 mg/kg. In addition, pharmacological immunomodulatory effects related findings were also demonstrated in 2,000mg/kg treated female and male mice as hypertrophy and hyperplasia of lymphoid cells in the submandibular lymph nodes. Conclusions : Based on the results of this experiment, the approximate lethal dose (ALD) of PS extracts after single oral treatment in female and male mice were considered above 2,000 mg/kg, respectively. It should be carefully used in clinics because the possibilities of respiratory or neurological disorders were observed when administered over 2,000 mg/kg of PS extract related to amygdalin.

• Journal of Pharmaceutical Investigation
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• v.34 no.1
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• pp.49-55
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• 2004

To develop a aceclofenac soft capsule, four preparations with various solubilizers were prepared and their dissolution test was carried out. Among four preparations tested, a preparation with ethanolamine was selected as a formula of aceclofenac soft capsule (Clanza $S^{TM}$), since it showed the fastεst dissolution rate. Bioequivalence of aceclofenac tablet, $Airtal^{TM}$ (Dae-Woong Pharmaceutical Co., Ltd.) and aceclofenac soft capsule, Clanza $S^{TM}$ (Korea United Pharmaceutical Co., Ltd.) was evaluated according to the guideline of KA Fourteen normal male volunteers (age 20 - 25 years old) were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After oral administration of one tablet or capsule containing 100 mg of aceclofenac, blood was taken at predetermined time intervals and the concentration of aceclofenac in plasma was determined with an HPLC method under UV detector The pharmacokinetic parameters ($C_{max}$ and $AUC_t$) were calculated and ANOVA was utilized for the statistical analysis of parameters using logarithmetically transformed $AUC_t$, $C_{max}$ and $T_{max}$. The results showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between Aral tablet and Clanza soft capsule were 2.89%, 0.18% and 43.0%, 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(15) (e.g. log(0.81) -log(1.23) ad log(0.89) -log(1.4)) fo $AUC_t$ and $C_{max}$, respectively. Thus, the criteria of the KFDA guidelines for the equivalence was satisfied, indicating that Clanza $S^{TM}$ soft capsule is bioequivalent to$Airtal^{TM}$ tablet.

• Progress in Medical Physics
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• v.20 no.1
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• pp.21-29
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• 2009

Breast cancer is the most common form of cancer among korean woman. Therefore, the early detection activities of breast cancer such as breast self-examinations, clinical breast examinations, mammography are important. A yearly mammography examination has been recommended for women aged 40 and older for the early detection of breast cancer in asymptomatic periods. However, the glandular tissue of breast is the most radiation-sensitive tissue, and the determination of average glandular dose (AGD) forms an important part of the quality control of the mammographic systems. Because of the difficulty of estimating AGD directly, it is often estimated from the measurements of the incident air kerma and by applying the appropriate conversion factors. The primary objective of this study was to standardize the method of measuring AGD. The secondary objective was to evaluate the relationships between AGD per various composition and thickness of the breast using Monte Carlo simulations. As a result, we standardized the method of measuring AGD according to International Atomic Energy Agency (IAEA) guidelines (CoP: an international code of practice). Overall, AGD for mammographic practice in Korea was less than 3.0 mGy recommended by the Korea Food and Drug Adminstration (KFDA) protocol, and Korean Institute for Accreditation of Medical Image (KIAMI). The measured and simulated AGD for a given condition were calculated as 1.7 and 1.6 mGy, respectively. For the AGDs obtained, there was no significant difference between them. The simulated AGD was dependent on the fraction of glandular tissue of the breast. The AGD increases with increasing of the breast glandularity due to increasing absorption of low energy photons. The AGD also increases as a function of breast thickness. In conclusion, the results of this study could be used as a baseline to establish a reference level of radiation dose in mammography.

• Journal of the Korean Society of Food Science and Nutrition
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• v.46 no.9
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• pp.1128-1136
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• 2017

Previous studies of the caffeine consumption pattern were limited primarily to beverages containing caffeine. Therefore, this study examined the caffeine consumption patterns and levels in beverages and foods containing caffeine among high school students (n=310) in the Yongin region. The participants included 171 boys (55.2%) and 139 girls (44.8%). The daily mean caffeine intake of the respondents was 41.27 mg (0.651 mg/kg) and 36.47 mg (0.696 mg/kg) in boys and girls, respectively. Among the caffeinated food groups, coffee had the highest caffeine intake group in both boys (18.95 mg) and girls (26.28 mg). Girls consumed large amounts of caffeine in the form of Americano-style coffee (20.04 mg), whereas boys consumed more canned coffee (6.77 mg) than girls (2.43 mg, P<0.01). Carbonated soft drinks were the second most prevalent source of caffeine intake in both groups, even though boys (14.29 mg) consumed larger amounts of caffeine than girls (5.85 mg, P<0.001). Multiple regression analysis investigating the major contributing food group to daily total caffeine intake also showed that the highest standardized coefficient was in coffee regardless of gender (boys 0.492, P<0.001 and girls 0.944, P<0.001), followed by carbonated soft drinks and energy drinks. Approximately 95% of high school students consumed normal levels of caffeine, whereas 3.5% of boys and 5.8% of girls consumed excessive amounts based on the standard limit of Korea Food and Drug Administration (<2.5 mg/kg/d) for adolescents. The daily mean caffeine intake of the excess group was 5.38 mg/kg and 6.96 mg/kg in boys and girls, respectively. Consequently, safe daily caffeine intake needs to be determined throughout continuous national management guidelines and nutritional education.