• Title/Summary/Keyword: Drug safety assessment

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Development of Restaurant Assessment Questionnaire for Application of Concept of Green Growth (녹색성장 개념을 적용한 음식점 평가지 개발)

  • Jung, Eun-Kyung;Park, Ki-Hwan;Lee, Ae-Rang;Kim, Gun-Hee;Yoo, Kyung-Mi;Ryu, Jung-Min;Lee, Hwa-Jung;Joo, Na-Mi
    • Korean journal of food and cookery science
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    • v.26 no.6
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    • pp.811-820
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    • 2010
  • The purpose of this study was to investigate the practices for management manual development of Good Restaurants in order to apply Green Safety Management technology. A total of 128 restaurants in Seoul according to restaurant size and style were analyzed by SPSS (window ver. 12.0). Exactly 38.3% of those surveyed purchased manicured vegetables and seafood that generates less garbage; Korean restaurants displayed the lowest frequency of purchasing preprocessed foodstuff, and Japanese restaurants had the most refrigerators and thermometers and kept the refrigeration temperature the lowest. Exactly 56.5% of the restaurants sold large and small amounts of main menu separately; Chinese restaurants displayed the highest rate while Western restaurants displayed the lowest. Furthermore, only 7.3% of the restaurants were willing to sell either large or small amounts of the same menu item. Japanese style menu had the most number of side dishes (6.1) while Western style menu had the lowest (1.8). Most of the restaurants were equipped with containers for leftovers (87.4%), but the rate of customers who took out leftovers significantly differed depending on the style of restaurant (p<0.05).

Development and Validation of an Analytical Method for Glucuronolactone in Energy Drinks by Hydrophilic Interaction Liquid Chromatography-electrospray Tandem Mass Spectrometry

  • Oh, Mi Hyune;Lim, Moo Song;Chai, Jeung Young;Kim, Eun Jung;Cho, Joong Hoon;Lim, Chul Joo;Choi, Sun Ok
    • Journal of Food Hygiene and Safety
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    • v.32 no.2
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    • pp.89-95
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    • 2017
  • A rapid, sensitive analytical method for glucuronolactone in beverages was developed and validated using hydrophilic interaction liquid chromatography coupled to electrospray ionization tandem mass spectrometry (HILIC-ESI-MS/MS). To determine the optimum analytical conditions for glucuronolactone, three different kinds of HILIC columns and two mobile phases with different pH values were examined. An amide-bonded stationary phase with a pH 9 acetonitrile-rich mobile phase was the best condition in terms of column retention, ESI-MS/MS response area, and signal-to-noise ratio. After extraction, glucuronolactone was separated through the HILIC amide column and detected by negative ESI-MS/MS in selected reaction monitoring (SRM) mode. Nine energy drinks sold in Korea were spiked with glucuronolactone at a concentration of 5 ng/mL; the Monster $Energy^{TM}$ sample showed the smallest peak area and its signal-to-noise ratio was used for method validation. Good linearity was obtained in the concentration range from 20 to 1500 ng/mL with a correlation coefficient > 0.998. The developed method had a limit of detection (LOD) of 6 ng/mL and a limit of quantitation (LOQ) of 20 ng/mL. The recovery of this method at concentration of 20, 100, 500, and 1000 ng/mL was 96.3%-99.2% with relative standard deviations (RSD) of 1.6%-14.0%. A reproducibility precision assessment at concentration of 100 and 500 ng/mL was carried out among three laboratories. The recovery of that evaluation was 95.1%-102.3% with RSD of 2.7%-7.0%. An analysis of variance indicated that there was no difference between the recovery results of the three laboratories at the 5% significance level. The validated method is applicable to inspecting beverages adulterated with glucuronolactone in Korea.

Analysis of Vitamin $B_{12}$ in the Korean Representative Foods and Dietary Intake Assessment for Koreans

  • Choi, Youn-Ju;Kim, Ji-Yung;Lee, Haeng-Shin;Kim, Cho-Il;Hwang, In-Kyeong;Park, Hye-Kyung;Kim, Tae-Hwa;Oh, Chang-Hwan
    • Food Science and Biotechnology
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    • v.17 no.2
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    • pp.262-266
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    • 2008
  • This study was conducted to provide a vitamin $B_{12}$ database for the representative Korean food items and to assess the dietary intake assessment of vitamin $B_{12}$ for Koreans. The vitamin $B_{12}$ content of 106 foods had been determined by high performance liquid chromatography (HPLC) using column switching method. Rich sources of vitamin $B_{12}$ were meats, milk, and egg ($0.3-3.4\;{\mu}g/100g$). Vegetables and fruits contained vitamin $B_{12}$ below limit of detection (LOD). The major food sources for vitamin $B_{12}$ intake were milk (72.0%), meats (22.3%), egg (3.6%), and fishes & shellfishes (2.1%). Mean vitamin $B_{12}$ intake of Koreans was $3.16\;{\mu}g$/person/day. The proportion of population with intake below estimate average requirement (EAR) and above recommended intake (RI) of vitamin $B_{12}$ was 60.7 and 36.5%, respectively. The vitamin $B_{12}$ intake level of young children with 1-2 years which was 834.6% of RI while the intake level of the older adults 50 years and older was only 70.0% of RI. Also, there were regional differences between urban and rural area. The population with intake below RI was larger than that with intake above RI in Korea.

Prescribing Patterns of Codeine among Children under Aged 12 in Korea (건강보험자료를 이용한 12세 미만 소아에서 코데인 처방양상평가)

  • Park, Hyo-Ju;Shin, Han-Na;Shin, Ju-Young
    • Korean Journal of Clinical Pharmacy
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    • v.25 no.4
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    • pp.273-279
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    • 2015
  • Objective: Codeine may result in death or respiratory depression in children, particularly who are rapid metabolizer of CYP2D6, therefore it should be used cautiously among children under 12 years of age. This study was to investigate the prescribing pattern of codeine among children according to the age group, prescribed diagnosis, type of medical service and medical specialties. Method: We used Korea Health Insurance Review and Assessment Service-National Patient Sample (HIRA-NPS) database. Study subjects included inpatients or outpatients, who were prescribed codeine between January, 1, 2011 and December, 31, 2011. Contraindicated use of codeine was defined as the use of codeine at least one times under aged 12. Age groups were subclassified according to the <2 years, 2-4 years, 5-8 years, and 9-11 years. Frequently prescribed diagnosis (ICD-10), type of medical service, and medical specialties were also described among codeine users under aged 12. Results: Codeine users were 6,411 inpatients (9,958 prescriptions), and 3,397 outpatients (6,258 prescriptions), respectively. Codeine prescription under 12 years of age were 2.1% (210 prescriptions) among inpatients, and 12.3% (776 prescriptions) among outpatients (p-value<0.05). Outpatient prescriptions of codeine under 12 aged were issued mostly from primary care clinics and frequent diagnosis were unspecified bronchopneumonia (51.6%), and vasomotor rhinitis (23.7%). Conclusion: This study found prescribing of codeine under 12 aged is common in outpatient and primary clinics. Nationwide and community-based efforts should be needed to reduce inappropriate prescribing among children.

Hepatotoxic Events Associated with Herbal Medicinal Products, Folk Remedies and Food Supplements in Korea (국내에서 보고된 한약 및 민간요법, 건강식품 관련 약인성간손상에 대한 체계적 고찰)

  • Park, Hae-Mo;Jang, In-Soo;Lee, Sun-Dong
    • The Journal of Korean Medicine
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    • v.26 no.2 s.62
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    • pp.152-165
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    • 2005
  • Background: The use of herbal preparations as remedies for various medical conditions has continuously increased in Korea Large proportions of Korean patients use herbal medicinal products, folk remedies, and food supplements. However, studies on the safety of herbal products arc conducted on a less than sufficient basis even in the countries like Korea where herbal medicine is being used extensively. Some of the reports on the safety of herbs were done by the doctors of western medicine but lack of knowledge and misclassification led to misunderstandings. Objecitves: This study aims to review the recent evidences on hepatotoxic events associated with the use of herbal medicinal products, folk remedy, and food supplements. In the process, this review will grasp trends in this field of studies and will direct further researches into the right direction. Methods: Systematic literature searches were performed on MedRic and MEDLIS in Korea. Screening and selection of the articles and the extraction of data were performed independently by two of authors. There were no restrictions regarding the published date. In order to avoid bias, the articles written by medical doctors, not by oriental doctors were selected. 43 journals were chosen for the review. Results: Analyzing the number of journals, studies on the drug-induced liver injury were increased after the year 2000. The proportion of herbal and folk remedy associated hepatotoxic injuries in all drug-induced liver injury was $21.0\%-30.0\%$. But criterion for herbal medicine is rather vague and limited objective data hindered objectiveness. Few of single medicinal herbs and combination preparations were associated with hepatotoxic injuries. But because of lack of objectivity, further researches must be conducted to yield more concrete results. Conclusions: yield more concrete results. Incidence figures are largely unknown, and in most cases a causal attribution is not established. The challenge for the future is to systematically research this area, educate all parties involved, and minimize patient risks.

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Detection of Genetically Modified Maize Safety-approved in Korea Using PCR (PCR을 이용한 국내에서 안전성이 확인된 유전자재조합 옥수수의 분석 방법)

  • Heo, Mun-Seok;Kim, Jae-Hwan;Park, Sun-Hee;Woo, Geon-Jo;Kim, Hae-Yeong
    • Korean Journal of Food Science and Technology
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    • v.35 no.6
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    • pp.1033-1038
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    • 2003
  • Four lines (MON810, GA21, NK603, and TC1507)of genetically modified maize(GMM) were recently approved after a safety-assessment by the Korea Food and Drug Administration (KFDA). In this study, five pairs of specific oligonucleotide primers, based on the gene sequences inserted into maize and zein gene as internal standards, were designed and a method using PCR was developed for monitoring GMM and GMM derived foods circulating in the market. MON810 and GA21 were detected in raw materials of feed and food in the Korean market.

Prioritizing Management Ranking for Hazardous Chemicals Reflecting Aggregate Exposure (통합노출을 고려한 유해물질 관리의 우선순위 선정)

  • Jeong, Ji-Yoon;Jung, Yoo-Kyung;Hwang, Myung-Sil;Jung, Ki-Kyung;Yoon, Hae-Jung
    • Journal of Food Hygiene and Safety
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    • v.27 no.4
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    • pp.349-355
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    • 2012
  • In this study, we configured a system which ranks hazardous chemicals to determine their management priorities based on experts' opinions and the existing CRS (chemical ranking and scoring). Aggregate exposure of food, health functional food, oriental/herbal medicine and cosmetics have been taken into account to determine management priority. In this study, 25 hazardous chemicals were selected, such as cadmium, lead, mercury, and arsenic, etc. These 25 materials were ranked according to their 1) risk (exposure or hazard) indexes, 2) exposure source-based weight, and 3) public interests, which were also formed based on the existing priority ranking system. Cadmium was scored the highest (178.5) and bisphenol A the lowest (56.8). Ten materials -- cadmium, lead, mercury, arsenic, tar, acrylamide, benzopyrene, aluminium, benzene, and PAHs -- scored higher than 100. Eight materials -- aflatoxin, manganese, phthalate, chromium, nitrate/nitrite, ethylcarbamate, formaldehyde, and copper -- recorded scores in the range from 70 to 100. Also evaluated as potential risks were 7 materials; sulfur dioxide, ochratoxin, dioxins, PCBs, fumonisin, methyl mercury, and bisphenol A, and these materials were scored above 50. Then we compared risk index and correlation coefficient of total scores to confirm the validity of the total scores; we analyzed correlation coefficient of parameter and indicator. We discovered that the total score and weight, which has incorporated public interests, were high and statistically significant. In conclusion, the result of this study contributes to strengthening risk assessment and risk management of hazardous chemicals.

Quality Control of Radiation Dosimetry Service (개인피폭선량 측정기관의 품질관리기준 개발)

  • Lee, Jun-Haeng;Lee, Sang-Bock;Chang, Kun-Jo;Lee, Kwang-Yong;Lee, Hyun-Koo;Kim, Hyeog-Ju;Jin, Gye-Hwan
    • Progress in Medical Physics
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    • v.20 no.4
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    • pp.253-259
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    • 2009
  • We have developed standards based on international criterions for the quality control of dose tested by the measurement institutions of individual exposure doses through improving the reliability of data on the exposure dose of individuals working in radioactive environment and securing the accuracy and reliability of individual dose measurements. Laws related to radiation dose applied to domestic institutions refer to ANSI N13.11.1993, but currently, in U.S. and some other countries the measurement of radiation doses is based on ANSI N13.11.2001 that reduced test categories and tightened the standards. We made efforts to simplify the standards and to reduce the number of dosimeters required in experiment, and avoided preventing or hindering the use of future technologies not approved under the current law such as glass dosimeter and optical stimulation dosimeter. The Quality Management Manual of Radiation Dosimetry Service, Assessment Manual of Radiation Dosimetry Service Accreditation Program, and the Personnel Dosimetry Performance. Criteria for Testing are documents applicable in supervising laboratories.

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Gene Expression Profiling of Acetaminophen Induced Hepatotoxicity in Mice

  • Suh, Soo-Kyung;Jung, Ki-Kyung;Jeong, Youn-Kyoung;Kim, Hyun-Ju;Lee, Woo-Sun;Koo, Ye-Mo;Kim, Tae-Gyun;Kang, Jin-Seok;Kim, Joo-Hwan;Lee, Eun-Mi;Park, Sue-Nie;Kim, Seung-Hee;Jung, Hai-Kwan
    • Molecular & Cellular Toxicology
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    • v.2 no.4
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    • pp.236-243
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    • 2006
  • Microarray analysis of gene expression has become a powerful approach for exploring the biological effects of drugs, particularly at the stage of toxicology and safety assessment. Acetaminophen (APAP) has been known to induce necrosis in liver, but the molecular mechanism involved has not been fully understood. In this study, we investigated gene expression changes of APAP using microarray technology. APAP was orally administered with a single dose of 50 mg/kg or 500 mg/kg into ICR mice and the animals were sacrificed at 6, 24 and 72 h of APAP administration. Serum biochemical markers for liver toxicity were measured to estimate the maximal toxic time and hepatic gene expression was assessed using high-density oligonucleotide microarrays capable of determining the expression profile of >30,000 well-substantiated mouse genes. Significant alterations in gene expression were noted in the liver of APAP-administered mice. The most notable changes in APAP-administered mice were the expression of genes involved in apoptosis, cell cycle, and calcium signaling pathway, cystein metabolism, glutatione metabolism, and MAPK pathway. The majority of the genes upregulated included insulin-like growth factor binding protein 1, heme oxygenase 1, metallothionein 1, S100 calcium binding protein, caspase 4, and P21. The upregulation of apoptosis and cell cycle-related genes were paralleled to response to APAP. Most of the affected gene expressions were returned to control levels after 72 hr. In conclusion, we identified potential hepatotoxicity makers, and these expressions profiling lead to a better understanding of the molecular basis of APAP-induced hapatotoxicity.

Foods Derived from Cloned Animals and Management Policies in Worldwide

  • Lee, Soo-Jin;Jang, Yang-Ho;Kim, Hyo-Bi;Lee, Myoung-Heon;So, Byung-Jae;Yang, Byoung-Chul;Kang, Jong-Koo;Choe, Nong-Hoon
    • Food Science of Animal Resources
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    • v.32 no.4
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    • pp.389-395
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    • 2012
  • Cloned animals are a result of asexual reproduction of animals using somatic cell nuclear transfer. Ever since the first report of a cloned sheep 'Dolly' produced by SCNT, increasing numbers of livestock, such as bovine and swine clones, have been generated worldwide. Foods derived from cloned animals have not been produced yet. However, the food safety of cloned animals has provoked controversy. The EU Food Safety Authority and U.S. Food and Drug Administration announced that milk and meat from cloned and non-cloned animals have no difference regarding food safety. However, food derived from cloned animals is considered unsuitable for eating vaguely. Moreover, there were scant information about cloned animals in Korea. Therefore, we surveyed the number of cloned animals worldwide including Korea and summarized the reports for cloned animals and discussed predictable problems.