• Title/Summary/Keyword: Drug labeling

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Monitoring of Restaurant Beef Labeling System (음식점 식육 원산지 표시 모니터링)

  • Hong, Jin;Leem, Dong-Gil;Kim, Mi-Gyeong;Park, Kyoung-Sik;Yoon, Tae-Hyung;No, Ki-Mi;Jeong, Ja-Young
    • 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.

A Study on the Labeling Efficiency and Cytotoxicity of Hepatocyte-targeting Galactosylated Chitosan Compounds (간세포 지향성 Galactosylated Chitosan 화합물의 표지 수율 향상 및 세포 독성에 대한 연구)

  • Kim, Dae-Weung;Jeong, Hwan-Jeong;Kim, Eun-Mi;Kim, Se-Lim;Kang, Yun-Hee;Kim, Min-Woo;Kim, Chang-Guhn;Sohn, Myung-Hee
    • The Korean Journal of Nuclear Medicine
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    • v.39 no.5
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    • pp.278-283
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    • 2005
  • Purpose: In prior study, we synthesized $^{99m}Tc$-galactosylated chitosan (GC) and performed in vivo biodistribution study, showed specific targeting to hepatocyte. The aim of this study is to evaluate the labeling efficiency and cytotoxicity of modified galactosylated chitosan compounds, galactosyl methylated chitosan (GMC) and HYNIC-galactosylated chitosan (GCH). Materials and Methods: GC, GMC and GCH were synthesized and radiolabeled with $^{99m}Tc$. Then, they were incubated for 6 hours at room temperature and human serum at $37^{\circ}C$. Labeling efficiencies were determined at 15, 30 m, 1, 2, 3 and 6 h after radiolabeling. To evaluate cytotoxicity, MTT assay was performed in HeLa and HepG2 cells. Results: In comparison with them of $^{99m}Tc$-GC labeling efficiencies of $^{99m}Tc$-GMC were significantly improved (100, 97 and 89%) in acetone and 96.3, 95.8 and 75.6% in saline at 15 m, 1 and 6 h, respectively). Moreover, $^{99m}Tc$-GCH showed more improved labeling efficiencies (>95% in acetone and human serum and >90% in saline at 6 h). In MTT assay, cytotoxicity was very low and not different from that of controls. Conclusion: These results represent that these compounds are radiochemically compatible radiopharmaceuticals, can be used in hepatocyte specific imaging study and in vivo gene or drug delivery monitoring.

Improvement of Analysis Methods for Fatty Acids in Infant Formula by Gas Chromatography Flame-Ionization Detector (GC-FID를 이용한 조제유류 중 지방산 분석법 개선 연구)

  • Hwang, Keum Hee;Choi, Won Hee;Hu, Soo Jung;Lee, Hye young;Hwang, Kyung Mi
    • Journal of Food Hygiene and Safety
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    • v.36 no.1
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    • pp.34-41
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    • 2021
  • The purpose of this research is to improve analysis methods of determining the contents of fatty acids in infant formulas and follow-up formulas. A gas chromatography (GC) method was performed on a GC system coupled to flame ionization detector, with a fused silica capillary column (SP2560, 100 m×0.25 mm, 0.20 ㎛). The method was validated using standard reference material (SRM, NIST 1849a). Performance parameters for method validation such as specificity, linearity, limits of detection (LOD) and quantification (LOQ), accuracy and precision were examined. The linearity of standard solution with correlation coefficient was higher than 0.999 in the range of 0.1-5 mg/mL. The LOD and LOQ were 0.01-0.06 mg/mL and 0.03-0.2 mg/mL, respectively. The recovery using standard reference material was confirmed and the precision was found to be between 0.8% and 2.9% relative standard deviation (RSD). Optimized methods were applied in sample analysis to verify the reliability. All the tested products had acceptable contents of fatty acids compared with component specification for nutrition labeling. The result of this research will provide efficient experimental information and strengthen the management of nutrients in infant formula and follow-up formula.

What makes Consumers to Prolong their Consumption on Perishable Food beyond Its Expiration Date?

  • Suh, Hyunsuk;Ju, Hyoungjun
    • Asia Marketing Journal
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    • v.15 no.2
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    • pp.133-173
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    • 2013
  • Consumers empty perfectly safe to intake perishable foods everyday if they are older than what prints on expiration date. The variation in expiration dating is freshness labeling represented in various terms such as sell by, package, best before, and so on. Regardless of the terms used and meanings are attached, consumers tend to conceive of freshness labeling on food as end of its shelf-life. Consequently, the food waste becomes a big issue for businesses in food sector. In an effort to demonstrate flexibility on this, KFDA(Korea Food & Drug Administration) introduced "best before" date in domestic market place to reduce food waste, based on the food safety test conducted by KCA(Korea Consumer Agency 2009). The results indicated freshness labeling on food should not be considered as the end of its life. Current study examined the underlying mechanisms(i.e. risk perception, self-construals, and indecisiveness) that influence consumers' intention on prolonged consumption of food beyond its stamped date when the KCA test results are shown to them. In addition, the moderating effect of regulatory focus is tested in the causal relationships between underlying mechanisms and different groups of prolonged consumption intention. Study participants are divided into three groups of prolonged consumption intention: no-change, moderate-change, and wide-change. The group with moderate-change in intention being as our point of reference, logistic regression analyses are conducted on 276 sample population. The results indicated that consumers with high source credibility risk are likely to show wide-change in intention on prolonged consumption while physical risk did not show significance. The consumers with independent self-construal are likely to show no-change in intention on prolonged consumption while interdependent self-construal did not show significance. Indecisiveness showed association a group with wide-change in intention on prolonged consumption. The moderating effect of regulatory focus showed valid results in most situations; the promotion-focused consumers showed wide-change in intention, while prevention-focused consumers showed no-change in intention. Furthermore, the moderating effect of promotion-focus showed a dominant position over the causal effect of indecisiveness in which decisive consumers(i.e. no-change in intention); if they are promotion-focused they tend show for the wide-change in intention instead. It is important to note that for those promotion-focused consumers(or situations), promotion-related arguments are more effective, while for those prevention-focused consumers(or situations) prevention- related arguments are more effective means of persuasion.

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Expression Patterns of Cancer Stem Cell Markers During Specific Celecoxib Therapy in Multistep Rat Colon Carcinogenesis Bioassays

  • Salim, Elsayed I;Hegazi, Mona M;Kang, Jin Seok;Helmy, Hager M
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.3
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    • pp.1023-1035
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    • 2016
  • The purpose of this study was to investigate the role of colon cancer stem cells (CSCs) during chemically-induced rat multi-step colon carcinogenesis with or without the treatment with a specific cyclooxygenase-2 inhibitor drug (celecoxib). Two experiments were performed, the first, a short term 12 week colon carcinogenesis bioassay in which only surrogate markers for colon cancer, aberrant crypt foci (ACF) lesions, were formed. The other experiment was a medium term colon cancer rat assay in which tumors had developed after 32 weeks. Treatment with celecoxib lowered the numbers of ACF, as well as the tumor volumes and multiplicities after 32 weeks. Immunohistochemical proliferating cell nuclear antigen (PCNA) labeling indexes LI (%) were downregulated after treatment by celecoxib. Also different cell surface antigens known to associate with CSCs such as the epithelial cell adhesion molecule (EpCAM), CD44 and CD133 were compared between the two experiments and showed differential expression patterns depending on the stage of carcinogenesis and treatment with celecoxib. Flow cytometric analysis demonstrated that the numbers of CD133 cells were increased in the colonic epithelium after 12 weeks while those of CD44 but not CD133 cells were increased after 32 weeks. Moreover, aldehyde dehydrogenase-1 activity levels in the colonic epithelium (a known CSC marker) detected by ELISA assay were found down-regulated after 12 weeks, but were up-regulated after 32 weeks. The data have also shown that the protective effect of celecoxib on these specific markers and populations of CSCs and on other molecular processes such as apoptosis targeted by this drug may vary depending on the genetic and phenotypic stages of carcinogenesis. Therefore, uncovering these distinction roles of CSCs during different phases of carcinogenesis and during specific treatment could be useful for targeted therapy.

The Liability for Unsafe Medical Product and The Preemption Clause of Medical Device Act (의료기기의 결함으로 인한 손해배상책임과 미국 연방법 우선 적용 이론에 관하여)

  • Kim, Jang Han
    • The Korean Society of Law and Medicine
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    • v.15 no.2
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    • pp.63-89
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    • 2014
  • In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

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Two-Cell Spheroid Angiogenesis Assay System Using Both Endothelial Colony Forming Cells and Mesenchymal Stem Cells

  • Shah, Sajita;Kang, Kyu-Tae
    • Biomolecules & Therapeutics
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    • v.26 no.5
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    • pp.474-480
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    • 2018
  • Most angiogenesis assays are performed using endothelial cells. However, blood vessels are composed of two cell types: endothelial cells and pericytes. Thus, co-culture of two vascular cells should be employed to evaluate angiogenic properties. Here, we developed an in vitro 3-dimensional angiogenesis assay system using spheroids formed by two human vascular precursors: endothelial colony forming cells (ECFCs) and mesenchymal stem cells (MSCs). ECFCs, MSCs, or ECFCs+MSCs were cultured to form spheroids. Sprout formation from each spheroid was observed for 24 h by real-time cell recorder. Sprout number and length were higher in ECFC+MSC spheroids than ECFC-only spheroids. No sprouts were observed in MSC-only spheroids. Sprout formation by ECFC spheroids was increased by treatment with vascular endothelial growth factor (VEGF) or combination of VEGF and fibroblast growth factor-2 (FGF-2). Interestingly, there was no further increase in sprout formation by ECFC+MSC spheroids in response to VEGF or VEGF+FGF-2, suggesting that MSCs stimulate sprout formation by ECFCs. Immuno-fluorescent labeling technique revealed that MSCs surrounded ECFC-mediated sprout structures. We tested vatalanib, VEGF inhibitor, using ECFC and ECFC+MSC spheroids. Vatalanib significantly inhibited sprout formation in both spheroids. Of note, the $IC_{50}$ of vatalanib in ECFC+MSC spheroids at 24 h was $4.0{\pm}0.40{\mu}M$, which are more correlated with the data of previous animal studies when compared with ECFC spheroids ($0.2{\pm}0.03{\mu}M$). These results suggest that ECFC+MSC spheroids generate physiologically relevant sprout structures composed of two types of vascular cells, and will be an effective pre-clinical in vitro assay model to evaluate pro- or anti-angiogenic property.

Decreased Diethylnitrosamine-induced Liver Preneoplastic Lesions by Estradiol-3-benzoate Treatment

  • Kang, Jin-Seok;Park, Ki-Dae;Ahn, Byeong-Woo;Han, Beom-Seok
    • Toxicological Research
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    • v.27 no.4
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    • pp.247-251
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    • 2011
  • To clarify whether inhibitory effect of estrogen on liver tumor is associated with cell proliferation, we investigated its role in diethylnitrosamine (DEN)-induced rat preneoplastic lesions, with time sequenced manners. F344 male rats (n = 90) were divided into three groups at 5 weeks of age. The mini-osmotic pumps providing a continuous infusion of DEN was implanted into the abdominal cavity of each animal in group 1, 2 and 3 at 6 weeks of age. To see the effect of estrogen, pellet containing 1 or 10 ${\mu}g$ of estradiol-3-benzoate (EB) was implanted subcutaneously in the animals of groups 2 or 3, respectively, one week prior to DEN treatment. Ten animals of each group were euthanized at 10, 14 and 18 weeks after DEN treatment. Liver tissues at each time point were fixed in 10% phosphate-buffered formalin and were processed and embedded in paraffin and 5 ${\mu}g$ sections mounted on a silanized slide. Glutathione S-transferase placental form (GST-P) positive foci and 5-bromo-2-deoxyuridine (BrdU) labeling cells were detected at each time point. Area of GST-P positive foci in DEN+EB 1 or 10 ${\mu}g$ group was significantly decreased compared to DEN alone at 14 weeks (p < 0.01 or p < 0.05, respectively) an at 18 weeks (p < 0.05 or p < 0.01, respectively). BrdU index in DEN+EB 1 or 10 ${\mu}g$ groups was significantly decreased compared to DEN alone at 14 weeks and at 18 weeks (p < 0.01). Taken together, we conclude that EB treatment decrease the DEN-induced liver preneoplastic lesions and this may be associated with decrease of cellular proliferation.

Determination of β-Carotene in Infant Formulas by High-Performance Liquid Chromatography (HPLC를 이용한 조제유류 중 베타카로틴 함량 분석 연구)

  • Hwang, Kyung Mi;Bae, Ji Won;Hu, Soo Jung;Oh, Keum Soon
    • Journal of Food Hygiene and Safety
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    • v.34 no.4
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    • pp.334-339
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    • 2019
  • A procedure based on high-performance liquid chromatography (HPLC) is described to determine ${\beta}-carotene$ in infant formulas. The method for ${\beta}-carotene$ analysis was performed on a C18 reversed-phase column using acetonitrile/methanol/dichloromethane (6:1:3, v/v/v) as a mobile phase. ${\beta}-Carotene$ was determined in HPLC with photo diode array (PDA) detector. The parameters of validation were specificity, linearity, LOD, LOQ, accuracy, precision and repeatability. The specificity was confirmed by the retention time and the linearity ($R^2$), which was over 0.999 in the range of 0.125~2 mg/L. The detection and quantification limits were 0.064 and 0.193 mg/L, respectively. The accuracy and precision of this method using an STD spiked sample were 80~119% and 1.02~2.05% respectively. The method was applied to the analysis of various infant formula and follow-up formulas products containing ${\beta}-carotene$, and all the products contained acceptable levels of ${\beta}-carotene$ for nutrition labeling.

Intake of Processed Foods and the Effects of Nutrition Label Education in 5th Grade Children (초등학교 5학년 아동의 가공식품 섭취와 영양표시 교육의 효과)

  • Chang, Soon-Ok;Lee, Ok-Hee;Lee, Kyung-Shil
    • Journal of the Korean Dietetic Association
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    • v.14 no.2
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    • pp.166-175
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    • 2008
  • The effects of nutrition label education on the perception, nutrition knowledge, understanding and applicability of labeling for 81 5$^{th}$ grade students was assessed. Prior to the education, the students' purchasing behavior of processed food was assessed by self-administered questionnaires. The evaluation of subjects' perception and understanding on nutrition label was completed prior to and following four education sessions utilizing materials developed by Korea Food and Drug Administration and Korea Health Industry Development Institute. More than 90% and 15% of subjects purchased processed food weekly and daily, respectively. Considering the nutrition label became an important factor in food purchases following the education sessions. Perception of the value of nutrition label improved from 2.93 to 3.32, although the belief that nutrition labels contributed to the maintenance of good food intake was not significantly increased. The total nutrition knowledge score increased from 5.47 to 7.14 and understanding nutrients composition table was significantly improved (3.17 to 4.80). The results indicate that a school-based nutrition label education program might be an effective aid for adoption of healthier food choices by children.

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