• Progress in Medical Physics
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• v.20 no.4
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• pp.317-323
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• 2009

The standard dosimetry systems based on an absorbed dose to water recommend to use a planeparallel chamber for the calibration of such a low-megavoltage electron beam as a nominal energy of 6 MeV. For this energy ranges of an electron beam a cylindrical chamber should not be used for the routinely regular beam calibration, but the feasibility of the temporary use of a cylindrical chamber was studied to give temporary solutions for special situations users meet. The PTW30013 chambers and the electron beam quality of $R_{50}=2.25\;g/cm^2$ were selected for this study. 10 PTW30013 chambers, a cylindrical type of chamber, were calibrated in KFDA, the secondary standards dosimetry laboratories, and given the absorbed dose-to-water calibration factors, respectively. A "temporary" $k_{Q,Q_0}$ for each chamber were calculated using the absorbed dose determined by a cross-calibrated planeparallel chamber, with the result of an average 0.9352 for 10 chambers. This value for PTW30013 chamber was used to determine an absorbed dose to water at the reference depth. The absorbed doses determined by PTW30013 chambers were in an agreement within 2% with that by ROOS chamber. In a certain situation where a cylindrical chamber be used instead of a planeparellel chamber, the value of 0.9352 might be useful to determine an absorbed dose to water in the same beam quality of electron beam as this study.

• Radiation Oncology Journal
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• v.24 no.2
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• pp.138-143
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• 2006

Purpose: To analyze the long-term stability of Farmer-type cylindrical ionization chambers by calibration factor provided from the KFDA (Korea Food Drug Administration) Materials and Methods: The cylindrical ionization chambers used in this study were the PTW 30001 (30006), 30013, 30002, 30004, 23333, the Capintec PR06C, the WE 2571, the Exradin A12 and the Wellhofer FC65G (IC70). We were analyzed that the $N_k$ and $N_{D.W}$ calibration factor for the cylindrical chambers and compared between the measured $N_{D.W}$ and calculated $N_{D.W}$ calibration factor. Results: We have observed that the long-term stability of the PTW 30013 (30006), the Wellhofer FC65G (IC70) and the NE 2571 has varied within 0.2%. The measured $N_{D,W}$ calibration factor was about 1.0% higher than the calculated $N_{D,W}$ that determined by the $N_k$ calibration factor. Conclusion: The study has evaluated that the long-term stability of the cylindrical chambers through analysis for the $N_k\;and\;N_{D,W}$ calibration factor. It has contributed to the improvement of clinical electron dosimetry in radiotherapy centers.

• Progress in Medical Physics
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• v.19 no.4
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• pp.276-284
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• 2008

A computed tomography (CT) is a powerful system for the effectively fast and accurate diagnosis. The CT system, therefore, has used substantially and developed for improving the performance over the past decade, resulting in growing concerns over the radiation dose from the CT. Advanced CT techniques, such as a multidetector row CT scanner and dual energy or dual source CT, have led to new clinical applications that could result in further increases of radiation does for both patients and workers. The objective of this study was to review the international guidelines of the shielding requirements for a CT facility required for a new installation or when modifying an existing one. We used Google Search Engine to search the following keywords: computed tomography, CT regulation or shield or protection, dual energy or dual source CT, multidetector CT, CT radiation protection, and regulatory or legislation or regulation CT. In addition, we searched some special websites, that were provided for sources of radiation protection, shielding, and regulation, RSNA, AAPM, FDA, NIH, RCR, ICRP, IRPA, ICRP, IAEA, WHO (See in Table 1 for full explanations of the abbreviations). We finally summarized results of the investigated materials for each country. The shielding requirement of the CT room design was very well documented in the countries of Canada, United States of America, and United Kingdom. The wall thickness of the CT room could be obtained by the iso-exposure contour or the point source method. Most of documents provided by international organizations were explained in importance of radiation reduction in patients and workers. However, there were no directly-related documents of shielding and patient exposure dose for the dual energy CT system. Based international guidelines, the guideline of the CT room shielding and radiation reduction in patients and workers should be specified for all kinds of CT systems, included in the dual energy CT. We proposed some possible strategies in this paper.

• Journal of Food Hygiene and Safety
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• v.23 no.1
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• pp.31-39
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• 2008

This study was performed to develop children's food quality certification system as part of the children's favorite foods safety management projects. As a component of the research, we developed a quality certification logo to build up brand image which is familiar with children, as well as to offer the right standard and opportunity for food selection. The age level contains elementary graders from 8 to 13. The logo concept was focused on 'Safety', 'Certification, Guidance' and 'Health' in accordance with the vision of the Korea Food and Drug Administration (KFDA), "Safe food, good nutrition and healthy children". The logo name was proposed as "Best Food for Children", "Safety Food for Children" and "Children Good Food", which was decided by public subscription in the KFDA. The 36 tentative plans for a seal were proposed depending on names. We conducted a survey for the 12 logo samples, designed by the name of "Children Good Food", to use as the basic material for the development of logo to convey the meaning of children's food quality certification system effectively. This survey was conducted among 321 elementary graders and 331 parents of elementary graders. We selected the most favorite design through the survey and applied it for products practicality. It is expected that a steady policy may be possible to implement by applying the basis of the children's food project.

• Journal of Pharmaceutical Investigation
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• v.35 no.3
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• pp.179-185
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• 2005

Acebrophylline is a compound produced by salifying ambroxol with theophylline-7 -acetic acid. After acebrophylline administration, the salt splits into these two components which feature a peculiar pharmacokinetic behavior, an adequate ambroxol and a low theophylline-7-acetic acid serum levels. The purpose of the present study was to evaluate the bioequivalence of two acebrophylline capsules, Surfolase (Hyundai Pharm. lnd. Co., Ltd.) and Burophil (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of ambroxol from the two acebrophylline formulations 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 eight healthy male subjects, $23.25{\pm}1.43$ years in age and $64.82{\pm}6.77$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two capsules containing 100 mg as acebrophylline were orally administered, blood was taken at predetermined time intervals and the concentrations of ambroxol in serum were determined using HPLC with electrochemical detector (ECD). The dissolution profiles of two formulations were similar at all dissolution media. In addition, 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 $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug Surfolase, were -1.64, -3.33 and -0.92% 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 $(e.g., \;log\;0.93{\sim}log\;1.05\;and\;log\;0.88{\sim}log\;1.05$ for $AUC_t$, and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Burophil capsule was bioequivalent to Surfolase capsule.

• Journal of Pharmaceutical Investigation
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• v.36 no.3
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• pp.209-215
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• 2006

Zaltoprofen, (2-(10,11-dihydro-10-oxodibenzo[b,f]thiepin-2-yl)propionic acid) is an NSAID with powerful anti-inflammatory effects as well as an analgesic action on inflammatory pain. The purpose of the present study was to evaluate the bioequivalence of two zaltoprofen tablets, $Soleton^{\circledR}$ (CJ Corp.) and SCD Zaltoprofen (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of zaltoprofen from the two zatoprofen formulations in vitro was tested using KP Vlll Apparatus ll method with various dissolution media. Twenty six healthy male subjects, $23.2{\pm}2.26$ years in age and$64.7{\pm}8.08$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 80 mg as zaltoprofen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of zaltoprofen in serum were determined using HPLC with 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 ANOVA test was 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, $Soleton^{\circledR}$ were 6.33, 5.91 and 17.7% for $AUC_t$, $C_{max}$ and untransformed $T_{max}$, 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 $1.01{\sim}1og\;1.11$ and log $0.928{\sim}1og\;1.18$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating SCD Zaltoprofen tablet was bioequivalent to $Soleton^{\circledR}$ tablet.

• Journal of the Korean Society of Radiology
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• v.10 no.7
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• pp.477-482
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• 2016

This study is tried to determine whether the management of medical radiation is well handled by comparison the guidelines of KFDA(korea food & drug administration) with analysis of dose indicator in mammography. As a method, it is analysed that kVp, exposure time, mAs, compressed breast thickness, average glandular dose and body mass index that were classified in the examination of both breasts by CC(cranio-caudal) and MLO(medio-lateral oblique) with EMR(electronic medical record) and dose report that were sent to the PACS(picture archiving communication system). As a result, in the site inspection according to the age, Compressed breast thickness in CC and MLO were the thickest of 45.6 mm and 49.6 mm in the 50-59 year old respectively. In the overall average compressed breast thickness, CC were 44.2 mm and MLO were 48.9 mm. MLO has more thick by 4.7 mm. In average glandular dose, CC were 1.05 mGy and MLO were 1.14 mGy. MLO has higher by 0.09 mGy than CC. As the compressed breast thickness increases 10mm, CC and MLO increases 0.15 mGy and 0.17 mGy respectively. When it was compared with the average glandular dose of 1.16 mGy per 1 film presented by KFDA, CC was showed 1.05 mGy. However, the 60 mm or more was found to exceed a 1.30 mGy. Also, As the compressed breast thickness was higher, body mass index showed high score. And in the case of 25 or more in the obese body index according to body mass index, it was showed obesity in case of the compressed breast thickness was more than 50mm.

• Journal of Pharmaceutical Investigation
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• v.31 no.4
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• pp.289-295
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• 2001

Carvedilol is an antihypertensive and antianginal compound that combines nonselective beta-adrenoceptor blocking and vasodilation properties and is devoid of intrinsic sympathomimetic activity. The purpose of the present study was to evaluate the bioequivalence of two carvedilol tablets, $Dilatrend^{TM}$ (Chong Kun Dang Pharmaceutical Co., Ltd.) and $Carvelol^{TM}$ (Dae Won Pharmaceutical Co., Ltd.), according to the prior and revised guidelines of Korea Food and Drug Administration (KFDA). The carvedilol release from the two carvedilol tablets 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, water and blend of PSB80 into water). Eighteen normal male volunteers, $24.22{\pm}1.86$ years in age and $64.81{\pm}4.56\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 25 mg of carvedilol was orally administered, blood was taken at predetermined time intervals and the concentrations of carvedilol in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two carvedilol tablets were very similar at all 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 using non-transformed and logarithmically transformed $AUC_t$ and $C_{max}$. The results showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between two tablets based on the $Dilatrend^{TM}$ were 2.23%, -2.00% and 0.00%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 13.55% and 17.61% for $AUC_t$ and $C_{max}$, respectively). The powers $(l-{\beta})$ at ${\alpha}=0.05$, ${\Delta}=0.2$ for $AUC_t$ and $C_{max}$ were 98.08% and 88.81%, respectively. The 90% confidence intervals were within ${\pm}20%$ (e.g., $-5.69{\sim}10.16$ and $-12.30{\sim}8.30$ for $AUC_t$ and $C_{max}$, respectively). There were no sequence effect between two tablets in logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals using logarithmically transformed were within the acceptance range of log(0.8) to log(1.25) (e.g., $0.95{\sim}1.11$ and $0.89{\sim}1.09$ for $AUC_t$ and $C_{max}$, respectively). Two parameters met the criteria of prior and revised KFDA guideline for bioequivalence, indicating that $Carvelol^{TM}$ tablet is bioequivalent to $Dilatrend^{TM}$ tablet.

• Journal of Food Hygiene and Safety
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• v.25 no.2
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• pp.162-169
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• 2010

The compulsory beef labelling system has launched from January 1st 2007 by the amended Food Hygiene Law, we were checked the actual conditions of beef origin with a nationwide scale by the Hanwoo differentiation specific test method which was developed by Korea FDA using 90 SNP biomarkers. The test method is useful tool to differentiate the beef origin carrying out the mission of KFDA's annual food safety management guidance. Also we have technically transferred the Hanwoo differentiation specific test method to other institutes as well regional KFDA and established the training program as a regular course in Korea Human Resource Development Institute for Health and Welfare. The beef used in this study were collected according to the 2009 Food safety guidance in roast beef restaurants where business site area greater than 100 $m^2$. Total 216 samples were consisted of 48 samples of the Seoul area and 168 of the region. The monitoring result from restaurants in all the region of Korea showed that 3 of 216 Hanwoo-labelled beefs were found out as a non-Hanwoo (1.3%). This results are gradually deceasing trend compared with 34.0% in 2005, 30.1% in 2006, 3.2% in 2007 and 5.14% in 2008. From these data, the Hanwoo differentiation specific test method on the settlement of the compulsory beef labelling system has an important role. As a outcome of this project, we might be considered the early settlement of the compulsory beef labelling system, technically transferred to other institutes and the establishment of regular training program of the test method.

• Journal of the Korean Society of Food Science and Nutrition
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• v.39 no.10
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• pp.1555-1564
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• 2010

This study investigated consumer's recognition of food labeling in order to contribute to the development of food labels which are more informative to consumers. The questionnaires had been collected from 120 male and female customers living in Seoul with the age between 10's and 60's from November 2nd to November 7th 2009. For checking the food label at the time of purchase, 58.3% of the consumers checked the food label and the main reason for checking the food label was to confirm sell-by date (60.1%). Sixty percent of the consumers were satisfied with the current food labeling. Among those who are not satisfied, 30.6% complained about difficult terms to understand and 25.8% were dissatisfied with insufficient information. In every age group, most people were not satisfied with labeling on food ingredient and additives, followed by date of manufacture and sell-by date. 53.1% of consumers demanded to label date of manufacture and sell-by date together. For more clear information, consumers wanted use-by date (47.5%) rather than sell-by date (23.3%). 56.7% of consumers was dissatisfied with warning information such as allergic warning and the reasons for dissatisfaction were poor visibility (37.5%) and insufficient information (33.4%). Moreover most consumers (90.0%) showed little knowledge on irradiation. To improve of the food labeling standards into consumer-oriented standards, both amendment of the food labeling standards and consumer education will be necessary.