• Korean Journal of Clinical Pharmacy
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• v.15 no.1
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• pp.21-26
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• 2005

A bioequivalence study of CKD $Cefaclor^{(R)}$ capsule (Chong Kun Dang Pharm Co., Ltd) to $Ceclor^{(R)}$ capsule (Lilly Korea Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the cefaclor dose of 250 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. An improved high-performance liquid chromatorgraphy (HPLC) analytical method with UV detection was used to determine plasma cefaclor concentration in human volunteers for 8 hr after oral drug administration. The area under the plasma concentration-time curve from time zero to 8 hr ($AUC_{0-8hr}$) was calculated by the linear trapezoidal rule. the $C_{max}$ (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 $AUC_{0-8hr}\;and\;C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The $90{\%}$ confidence intervals of the $AUC_{0-8hr}$ ratio and the $C_{max}$ ratio for CKD $Cefaclor^{(R)}$ and $Ceclor^{(R)}$ were $0.9400{\leq}{\delta}{\leq}1.0345$ and $0.8858{\leq}{\delta}{\leq}1.1021$, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the of CKD $cefaclor^{(R)}$ capsule was bioequivalent to $Cefaclor^{(R)}$ capsule with respect to its bioavailability.

• Progress in Medical Physics
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• v.18 no.3
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• pp.126-133
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• 2007

A head-and-neck phantom was designed in order to evaluate remotely the quality of the delivery dose of intensity modulated radiation therapy (IMRT) in each institution. The phantom is homogeneous or inhomogeneous by interchanging the phantom material with the substructure like an air or bone plug. Monte Carlo simulations were executed for one beam and three beams to the phantom and compared with ion chamber and thermoluminescent dosimeter (TLD) measurements of which readings were from two independent institutions. For single beam, the ion chamber results and the MC simulations agreed to within about 2% TLDs agreed with the MC results to within 2% or 7% according to which institution read the TLDs. For three beams, the ion chamber results showed -5% maximum discrepancy and those of TLDs were $+2{\sim}+3%$. The accuracy of the TLD leadings should be increased for the remote dose monitoring. MC simulations are a valuable tool to acquire the reliability of the measurements in developing a new phantom.

• Economic and Environmental Geology
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• v.48 no.3
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• pp.255-260
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• 2015

There are more than 2000 minerals on earth, and it has been implemented in various fields such as environment, architecture, livestock, chemistry, pharmaceuticals. Clay minerals are considered that they can change the physical and chemical properties through the adsorption and release of metal ions. Although domestic deposit of non-metallic mineral resources is approximately ninety-six billion tons, its application is limited and has hardly been used in high value-added industries involved in medicine, medical supplies, and functional food materials. Bentonite and zeolite are already used for cosmetic purposes and also used in living goods and packing materials. However, direct application to the food industry is relatively very rare. Since records regarding the intake of minerals for foods and medicines are found in the old literatures, the utilization of non-metallic minerals as food materials appears to be highly profitable. According to the trends in patent research for food and mineral resources, the company plays a main role for the development of the food containing non-metallic minerals in USA, and the trends confirms that this industry is emerging. Here, we provided the information about domestic and foreign patent trend for food industries involved in mineral resources and the application of mineral resources in the food industries. We also covered the domestic regulation regarding usage of mineral resources in food, and proposed domestic application plan for food production using mineral resources in the future.

• Korean Journal of Food Science and Technology
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• v.50 no.4
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• pp.377-382
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• 2018

An HPLC method was developed to quantitate a marker, oxyresveratrol (ORT), for the standardization of mulberry branch extracts (MBE) as a functional ingredient. HPLC was performed on a $C_{18}$ column with a gradient elution using 0.05% $H_3PO_4$ and acetonitrile at a flow rate of 0.8 mL/min, and detected at 320 nm. The HPLC method was validated according to Korea Food and Drug Administration (KFDA) guideline of analytical procedures with respect to specificity, linearity, accuracy and precision. Calibration curve of ORT showed high linearity ($R^2=1$), and limits of detection and quantification were 0.3 and $1.0{\mu}g/mL$, respectively. Relative standard deviation values from intra-and inter-day precision were less than 3.52 and 4.70%, respectively. Recovery rate ranged from 97.64% to 103.69%, and ORT content in MBE was approximately 3.78%. These results suggest that the HPLC method developed for the analysis of ORT in MBE is simple, efficient, and could contribute to the quality control of MBE.

• Journal of Food Hygiene and Safety
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• v.26 no.3
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• pp.248-253
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• 2011

KFDA compiles the statistical data of food poisoning outbreaks two or more persons since 2002 in Korea and release them to the public on the web. There is a gap of outbreak number between the real situation and the reports. To reduce the gap, addition of sporadic individual case of food poisoning may be one of the solution method. The statistical data of Japan where food consumption pattern is similar to Korea, were used in this study to compare the ratio and the pattern between the outbreak cases two or more persons and individual cases. By doing so, the data of Japan regarding to outbreak cases two or more persons will be comparable to that of Korea. The data of 2002 and 2003 in Japan showed that sporadic individual cases were 43.3% in the total food poisoning cases. The individual cases occurred highly in unknown places (90-92.3%) and home (6.2-8.5%) whileas the outbreaks two or more persons occurred mostly in the place of restaurants (46.6-50.l%) and inns (9.2-9.8%). The food-borne pathogens attributed to the individual cases were C. jejuni (51.9%), Salmonella spp. (35.3%), and V. parahaemolyticus (9.8%) while those to the outbreak cases two or more persons were norovirus (31.3%), Salmonella spp. (20.8%), C. jejuni (15.5%) in Japan. The data of 2002-2009 between Korea and Japan showed the outbreak case report rate was 1:1.5 based on the total population number.

• Toxicological Research
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• v.28 no.2
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• pp.73-79
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• 2012

While the ability to develop nanomaterials and incorporate them into products is advancing rapidly worldwide, understanding of the potential health safety effects of nanomaterials has proceeded at a much slower pace. Since 2008, Korea Food and Drug Administration (KFDA) started an investigation to prepare "Strategic Action Plan" to evaluate safety and nano risk management associated with foods, drugs, medical devices and cosmetics using nano-scale materials. Although there are some studies related to potential risk of nanomaterials, physical-chemical characterization of nanomaterials is not clear yet and these do not offer enough information due to their limitations. Their uncertainties make it impossible to determine whether nanomaterials are actually hazardous to human. According to the above mention, we have some problems to conduct the human exposure risk assessment currently. On the other hand, uncertainty about safety may lead to polarized public debate and to businesses unwillingness for further nanotechnology investigation. Therefore, the criteria and methods to assess possible adverse effects of nanomaterials have been vigorously taken into consideration by many international organizations: the World Health Organization, the Organization for Economic and Commercial Development and the European Commission. The object of this study was to develop risk assessment principles for safety management of future nanoproducts and also to identify areas of research to strengthen risk assessment for nanomaterials. The research roadmaps which were proposed in this study will be helpful to fill up the current gaps in knowledge relevant nano risk assessment.

• Journal of Pharmaceutical Investigation
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• v.41 no.4
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• pp.255-262
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• 2011

Method using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) was developed and validated for the determination of pregabalin in plasma samples. Acquisition was performed by monitoring the transitions: m/z 160.1${\rightarrow}$142.2 for pregabalin and m/z 423.2${\rightarrow}$207.1 for losartan (as an internal standard). After cold acetonitrileinduced protein precipitation of the plasma samples, separation was performed with C18 column by isocratic mobile phase consisted of 10 mM ammonium acetate and acetonitrile (15:85, v/v). Results were linear over the concentration ranged from 0.1 to $10{\mu}g$/mL and the correlation coefficients (r) were $\geq0.99$. Intra- and inter-day precisions were $\leq6.02$ and $\leq11.04%$, respectively, and intra- and inter-day accuracies were 96.60-101.09 and 98.10-102.60%, respectively. This validated method was successfully applied to a bioequivalence study of two formulations of pregabalin, Daewoong pregabalin capsule (Daewoong Pharm. Co., Ltd.) and Lyrica$^{(R)}$ capsule (Pfizer Korea Ltd.) in twenty eight healthy Korean volunteers. The subjects received a single oral dose of each formulation (150 mg as pregabalin) in a randomized $2{\times}2$ crossover study and plasma samples were obtained from each subject at predetermined time intervals. Then, the pharmacokinetic parameters ($AUC_{0-t}$, $C_{max}$ and $T_{max}$) were calculated and statistically analyzed to assess the differences between two formulations. The 90% confidence intervals for the log-transformed data were acceptable range of log 0.8-log 1.25 (e.g., log 1.0048-log 1.0692 for AUC0-t, log 0.9142-log 1.0421 for $C_{max}$). Thus, $AUC_{0-t}$ and $C_{max}$ met the criteria of the Korea Food and Drug Administration (KFDA) for bioequivalence test indicating that Daewoong pregabalin capsule was bioequivalent to Lyrica$^{(R)}$ capsule.

• Korean Journal of Environmental Agriculture
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• v.30 no.1
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• pp.60-67
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• 2011

BACKGROUND: Because dried herbal medicines have many active ingredients, it is not easy to determine the residue amount after extraction, partition and clean up of pesticides from them. Especially, liquid-liquid partition method is consuming many times and solvents. Macroporous diatomaceous earth(MDE) column was used to replace the separatory funnel for liquid-liquid extraction with dichloromethane to analyze the endosulfan and its metabolite. METHODS AND RESULTS: The residue analysis method using MDE column instead of liquid-liquid partition for determining insecticide endosulfan and its metabolite in 4 dried herbal medicines was developed by GC/MS. As a result, the recovery rates of the pesticides in 4 herbal medicines were ranged from 80.3 to 93.5% for ${\alpha}$-endosulfan, from 81.0 to 100.3% for ${\beta}$-endosulfan and from 80.6 to 95.6% for endosulfan sulfate, respectively. The coefficients of variation for triplicate were ranged from 1.1 to 3.4%. CONCLUSION: The improved methods are more ecofriendly, safer, faster and less laborious than conventional method by KFDA.

• Journal of Pharmaceutical Investigation
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• v.33 no.3
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• pp.215-221
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• 2003

A bioequivalence study of $Ambrect^{TM}$ tablets (Dong Wha Pharm. Ind. Co., Ltd.) to $Mucopect^{TM}$ tablets (Boehringer Ingelheim Korea, Ltd.) was conducted according to the guideline of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korea volunteers received each medicine at the ambroxol hydrochloride dose of 30 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of ambroxol were monitored by a high-performance liquid chromatography for over a period of 24 hours after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 hr) was calulated by the linear trapezoidal rule method. $C_{max}$ (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 $AUC_t\;and\;C_{max}$. 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 $Ambrect^{TM}/Mucopect^{TM}$ were 0.89-1.01 and 0.89-1.02, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Ambrect^{TM}\;and\;Mucopect^{TM}$ with respect to the rate and extent of absorption.

• Korean Journal of Environmental Agriculture
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• v.28 no.4
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• pp.412-418
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• 2009

This study is conducted in order to know the residue patterns of insecticide cypermethrin and fungicide diethofencarb in ginseng sprayed by various application methods. Two pesticides were sprayed separately on ginseng using traditional, soil and vinyl mulching applications. The vinyl mulching application was that head part of ginseng protected from pesticides. When cypermethrin was sprayed on ginseng by traditional application, its residue amount in ginseng was 0.25 mg/kg which exceeded 0.1 mg/kg, maximum residue limit(MRL) established by Korea Food & Drug Administration(KFDA). But in case of vinyl mulching and soil application, its residue amounts were 0.04 and 0.07 mg/kg, respectively. The residue amount of diethofencarb in ginseng was 3.01 mg/kg which exceeded the MRL, 0.3 mg/kg. Further, in case of vinyl mulching and soil application, its residue amounts were 1.71 and 9.39 mg/kg which exceeded the MRL 0.3 mg/kg. Although the residue amounts of both pesticides exceeded the MRLs for ginseng, we can explain that pesticides remained in head part of ginseng is probably the reason why higher pesticides residue levels were observed.