• Title/Summary/Keyword: food and drug

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Performance Characteristic of a CsI(Tl) Flat Panel Detector Radiography System (CsI(TI) Indirect Flat Panel Detector의 선질에 따른 물리적 영상 평가)

  • Jeong, Hoi-Woun;Min, Jung-Hwan;Kim, Jung-Min;Park, Min-Seok;Lee, Gaung-Young
    • Journal of radiological science and technology
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    • v.35 no.2
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    • pp.109-117
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    • 2012
  • The purpose of this work was to evaluate an amorphous silicon cesium iodide based indirect flat-panel detector (FPD) in terms of their modulation transfer function (MTF), Wiener spectrum (WS, or noise power spectrum, NPS), and detective quantum efficiency (DQE). Measurements were made on flat-panel detector using the International Electrotechnical Commission (IEC) defined RQA3, RQA5, RQA7, and RQA9 radiographic technique. The MTFs of the systems were measured using an edge method. The WS(NPS) of the systems were determined for a range of exposure levels by two-dimensional (2D). Fourier analysis of uniformly exposed radiographs. The DQEs were assessed from the measured MTF, WS(NPS), exposure, and estimated ideal signal-to-noise ratios. Characteristic curve in the RQA3 showed difference in the characteristic curve from RQA5, RQA7, RQA9. MTFs were not differences according to x-ray beam quality. WS(NPS) was reduced with increasing dose, and RQA 3, RQA5, RQA7, RQA9 as the order is reduced. DQE represented the best in the 1mR, RQA 3, RQA5, RQA7, RQA9 decrease in the order. The physical imaging characteristics of FPD may also differ from input beam quality. This study gives an initial motivation that the physical imaging characteristics of FPD is an important issue for the right use of digital radiography system.

Acoustic outputs from clinical ballistic extracorporeal shock wave therapeutic devices (임상에서 사용중인 탄도형 체외충격파 치료기의 음향 출력)

  • Cho, Jin Sik;Kwon, Oh Bin;Jeon, Sung Joung;Lee, Min Young;Kim, Jong Min;Choi, Min Joo
    • The Journal of the Acoustical Society of Korea
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    • v.41 no.5
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    • pp.570-588
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    • 2022
  • We scrutinized the acoustic outputs from the 70 shock wave generators of the 15 product models whose technical documents were available, among the 46 ballistic extracorporeal shock wave therapeutic devices of 11 domestic and 6 foreign manufacturers, approved by the Minster of Food & Drug Safety (Rep. Korea). We found that the acoustic Energy Flux Density (EFD), the most popular exposure parameter, was different by up to 563.64 times among shock wave generators at their minimum output settings and by up to 74.62 times at their maximum settings. In the same product model, the EFD was shown to vary depending on shock wave transmitters by up to 81.82 times at its minimum output setting and by up to 46.15 times at its maximum setting. The lowest EFD 0.013 mJ/mm2 at the maximum output settings was much lower (2.1 %) than the maximum value 0.62 mJ/mm2 at the minimum settings. The Large acoustic output differences (tens to hundreds of times)from the therapeutic devices approved for the same clinical indications imply that their therapeutic efficacy & safety may not be assured. The findings suggest the regulatory authority to revise her guideline to give clearer criteria for clinical approval and equality in performance, and recommend the authority to initiate a post-approval surveillance as well as a test in conformance between the data in technical documents and the real acoustic outputs clinically used.

Acoustic outputs from clinical extracorporeal shock wave lithotripsy devices (임상에서 사용중인 체외충격파쇄석기의 음향 출력 분포)

  • Jong Min Kim;Oh Bin Kwon;Jin Sik Cho;Sung Joung Jeon;Ki Il Nam;Sung Yong Cho;Min Joo Choi
    • The Journal of the Acoustical Society of Korea
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    • v.42 no.5
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    • pp.469-490
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    • 2023
  • Survey was carried out on the acoustic outputs from 12 shock wave fields produced by the 10 extracorporeal shock wave lithotriptors whose technical documents are available, among the 33 devices approved by the Ministry of Food & Drug Safety (MFDS).The results show that the acoustic outputs (P+, P-, efd, and E), critical to the therapeutic efficacy and the patient safety, are largely different between the devices. The maximum values of P+, P-, efd, and E vary up to 2.08, 3.72, 3.89, and 15.98 times, respectively. The acoustic output parameters are not thoroughly provided in the technical documents, and some of data (eg. efd) are suspected to be abnormal outside usual ranges. The large device to device differences in the shock wave outputs are likely to undermine equivalence between the ESWL devices approved for the same indication. To verify the reliability of the data in the technical documents of the approved devices and to confirm if the acoustic outputs from the devices in clinical use are the same as those in their technical documents, an authorized test laboratory should be available. A postapproval monitoring led by the regulatory agency is suggested to maintain the acoustic outputs from the ESWL devices that suffer from degrading in performance due to aging.

Bacterial Filtration Efficiencies of KF94 Masks According to Wearing Duration (착용 기간에 따른 KF94 마스크 세균여과효율 변화 연구)

  • Jongmin Park;Yeram Yang;SungJun Park;Kiyoung Lee;Cheonghoon Lee;Chungsik Yoon
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.34 no.1
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    • pp.48-56
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    • 2024
  • Objectives: The coronavirus pandemic that began in 2019(COVID-19) has been one of the worst pandemics of the 21st century. Masks have been used to prevent COVID-19, but there are currently no standards for the long-term use of masks in the Republic of Korea. This study was conducted to assess the microbiological safety of KF94(Korea Filter 94) disposable face masks according to wearing duration by evaluating the bacterial filtration efficiencies of masks worn by research participants. Methods: A commercially available KF94 mask certified by the Ministry of Food and Drug Safety(MFDS) in the Republic of Korea was selected as the test mask. The research participants(n = 15) wore masks for the durations of one, three, and seven days. Participants also reported several parameters, including wearing time, makeup frequency, and storage. Bacterial filtration efficiencies of the worn masks were measured by a mask bioaerosol filtration tester. Staphylococcus aureus(S. aureus) was used as the test bacteria and quantitatively measured through the cultivation method. Then, bacterial filtration efficiency was calculated using the formula suggested by the MFDS. Results: All worn masks showed over 99.98% of mean bacterial filtration efficiency for S. aureus. There were no significant differences among bacterial filtration efficiencies of face masks according to wearing duration. There was also no significant difference among bacterial filtration efficiencies among participants. There was no correlation between the results of bacterial filtration efficiencies and reported parameters from participants. Conclusions: In the absence of significant external damage to the mask, the bacterial filtration efficiency of the mask can be maintained even after seven days of wearing. This result suggests that KF94 masks certified by the MFDS can be used repeatedly for about a week without loss of bacterial filtration efficiency.

The Recent Trend of the National and International Standard of Manufacturing Quality Control for Diagnostic X-ray Equipment (진단용엑스선장치 제조품질관리에 관한 국내.외 규격의 동향)

  • Choi, In-Seok;Kim, Jung-Min;Jeong, Hoi-Woun;Min, Jung-Whan;Lee, In-Su
    • Journal of radiological science and technology
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    • v.32 no.1
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    • pp.1-15
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    • 2009
  • Newly published IEC 60601-1-3 ; 2008 2nd Edition has two important meanings. First, Radiation Quality and Dose should make sure for safety of patient and staff in manufacturing diagnostic X-ray equipment. Second, it should be minimized of Leakage Radiation, Residual Radiation, and Stray Radiation. The requirement to make enactment or revision of national standard for diagnostic X-ray Equipment is as follows : 1. It should be adjusted the new standard to the recent IEC Publication under the consideration of the Korea medical circumstances. 2. For focus to the Radiation Safety, IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment) could be applied to the new regulation. It should be compact sentence. 3. A sudden Notification change should not be desired. It needs a enough time to make easy the circumstances.

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In vivo Biological Function of a Fibrinolytic Enzyme after Oral Adminstration (혈전용해효소의 경구투여에 의한 생체 내 작용)

  • Lee, Young-Hoon;Lee, Sung-Ho;Park, Ki-Hoon;Choi, Young-Ju;Lee, Sang-Won;Kim, Cheol-Ho;Cho, Soo-Jeong;Gal, Sang-Wan
    • KSBB Journal
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    • v.21 no.6 s.101
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    • pp.433-438
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    • 2006
  • A fibrinolytic enzyme gene (BCF-1) was subcloned to the pEB vector which is high expression vector in the Bacillus host. The enzyme was purified by using FPLC after ammonium sulfate precipitation. The enzyme was oral-administrated to the rat and checked the bleeding time, blood clotting time and fibrinolytic effect of the serum. In the bleeding time retardation test, it was longer about 1.7 fold in the feeding rat than without feeding. The serum of rat feeded with the enzyme had the fibrinolytic activity from 1 hour to 3 hours after oral-administration. After 3 hours from feeding, the fibrinolytic activity was decreased gradually. Also blood clotting time after bleeding was longer than that of control rat. The enzyme could be detected at band of 30,000 Da in the blood by western blotting. The enzyme was not harmful to the all internal organs of the rats. Taken together, the enzyme originated from B. subtilis BB-1 can be a candidate to develop the drug for thrombosis, arteriosclerosis and myocardial infarction.

Some Statistical Considerations on 2×k Crossover Designs for Bioequivalence Trial (생물학적 동등성 시험을 위한 2×k 교차설계법의 통계적 고려)

  • Noh, So-Young;Park, Sang-Gue
    • The Korean Journal of Applied Statistics
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    • v.26 no.4
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    • pp.675-686
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    • 2013
  • The Korea Food and Drug Administration(KFDA) recommends the use of a $2{\times}2$ crossover design to assess the bioequivalence of generic drugs. However, a standard $2{\times}2$ crossover design for bioequivalence trials is often considered problematic due to ethical and economic issues as highly variable drugs are usually required by large numbers of subjects when designing the trial. To overcome this problem a $2{\times}4$ crossover design has been a recommended option as per US regulations; in addition, a $2{\times}3$ crossover design has also recently drawn special attention as an efficient alternative. The current KFDA regulation requires an ANOVA table for every bioequivalence study; however, ANOVA tables of $2{\times}4$ and $2{\times}3$ crossover designs have never been published in the literature. This study shows the derivation of tables of analysis of variance for a $2{\times}4$ cross-over design and a $2{\times}3$ cross-over design. We also suggest a sample size formulas for $2{\times}2$, $2{\times}4$ and $2{\times}3$ crossover designs to provide information on the selection of efficient designs for highly variable drugs.

RBAC-based health care service platform for individual recommended health information service (RBAC에 기반한 개인 맞춤형 건강 정보 제공 헬스케어 서비스 플랫폼)

  • Song, Je-Min;Kim, Myung-Sic;Jeong, Kyeong-Ja;Shin, Moon-Sun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.15 no.3
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    • pp.1740-1748
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    • 2014
  • In this paper, we propose an RBAC based personalized health care service platform in order to provide smart management of personal health record using smart devices. It helps to guide healthful service and provide useful information according to one's individual health record. Personalized health care services platform supports a healthy lifestyle by measuring personal health information in a hospital clinical, imaging, and drug data, as well as that can be obtained from smart devices. Everyone can enter his health related data in everyday life such as food, sleeping time, mood, movement and exercise so that one can manage his personal health information of modern smart features. In addition, if necessary, personal health information can be provided to the hospital information system and staff with the consent of the individual. It can be contributed to simplify the complex process for remote medical. The proposed platform, which applies role based access control model to protect security and privacy, supports a smart health care services for users by providing personalized health care services through the smart applications.

Caffeic Acid Phenethyl Ester Induces the Expression of NAG-1 via Activating Transcription Factor 3 (ATF3를 통한 caffeic acid phenethyl ester에 의한 NAG-1 유전자의 발현 증가)

  • Park, Min-Hee;Chung, Chungwook;Lee, Seong Ho;Baek, Seung Joon;Kim, Jong Sik
    • Journal of Life Science
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    • v.28 no.1
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    • pp.37-42
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    • 2018
  • Non-steroidal anti-inflammatory drug-activated gene-1 (NAG-1) is a transforming growth factor beta (TGF-${\beta}$) superfamily gene associated with pro-apoptotic and anti-tumorigenic activities. In the present study, we investigated if caffeic acid phenethyl ester (CAPE) derived from propolis could induce the expression of anti-tumorigenic gene NAG-1. Our results indicate that CAPE significantly induced NAG-1 expression in a time- and concentration-dependent manner in HCT116 cells. We also found that CAPE induced NAG-1 expression in a concentration-dependent manner in another human colorectal cancer cell line, LOVO. In addition, CAPE triggered apoptosis, which was detected with Western blot analysis using poly-(ADP-ribose) polymerase antibody. NAG-1 induction by CAPE was not dependent on transcription factor p53, which was confirmed with Western blot analysis using p53 null HCT116 cells. The luciferase assay results indicated that the new cis-elements candidates were located between -474 and -1,086 of the NAG-1 gene promoter. CAPE dramatically induced activating transcription factor 3 (ATF3) expression, but not cAMP response element-binding protein (CREB), which shares the same binding sites with ATF3. The co-transfection experiment with pCG-ATF3 and pCREB showed that only ATF3 was associated with NAG-1 up-regulation by CAPE, whereas CREB had no effect. In conclusion, the results suggest that CAPE could induce the expression of anti-tumorigenic gene NAG-1 mainly through ATF3.

As (v) immobilization in an aqueous solution by zerovalent iron under various environmental conditions (영가철(Zerovalent Iron)을 이용한 수용액 중 비소(V)의 불용화)

  • Yoo, Kyung-Yoal;Ok, Yong-Sik;Yang, Jae-E.
    • Korean Journal of Environmental Agriculture
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    • v.26 no.3
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    • pp.197-203
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    • 2007
  • Zerovalent iron (ZVI) has been widely used in the removal of environmental contaminants from water. The objective of this research was to assess the efficiency of ZVI for immobilization of As (V) in the contaminated water under various chemical conditions. Batch-type experiments showed that the immobilization process followed a first-order kinetic model. Rate constant (k) of the reaction increased consistently and proportionally as increasing ZVI concentrations from 1% (0.158 $hr^{-1}$) to 3% (0.342 $hr^{-1}$), and temperatures from $15^{\circ}C$ (0.117 $hr^{-1}$) to $35^{\circ}C$ (0.246 $hr^{-1}$), respectively. Whereas the rate constant decreased as increasing As (V) concentrations from 1 mg $\Gamma^{-1}$ (0.284 $hr^{-1}$) to 3 mg $\Gamma^{-1}$ (0.153 $hr^{-1}$), and the initial pH from 3 (0.393 $hr^{-1}$) to 9 (0.067 $hr^{-1}$), respectively. Results demonstrated that As (V) in an aqueous solution was rapidly immobilized by ZVI treatments. Zerovalent iron was fast method for remediation of As (V) contaminated water.