• 제목/요약/키워드: Ministry of Food and Drug Safety in Korea

검색결과 314건 처리시간 0.029초

Neuroimaging in Randomized, Multi-Center Clinical Trials of Endovascular Treatment for Acute Ischemic Stroke: A Systematic Review

  • Chong Hyun Suh;Seung Chai Jung;Byungjun Kim;Se Jin Cho;Dong-Cheol Woo;Woo Yong Oh;Jong Gu Lee;Kyung Won Kim
    • Korean Journal of Radiology
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    • 제21권1호
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    • pp.42-57
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    • 2020
  • Appropriate use and analysis of neuroimaging techniques is an inevitable aspect of clinical trials for patients with acute ischemic stroke. Neuroimaging examinations were recently used to define the core eligibility criteria and outcomes in acute ischemic stroke research. Recent clinical trials for endovascular treatment in acute ischemic stroke have also demonstrated the efficacy or safety of endovascular treatment using various imaging modalities as well as clinical indices. Furthermore, independent imaging reviews and imaging core laboratory assessments are essential to manage and analyze imaging data in order to enhance the reliability of the outcomes. Therefore, we systematically reviewed the use of neuroimaging in recent randomized clinical trials for endovascular treatment of acute ischemic stroke in order to provide a thorough summary, which would serve as a resource guiding the use of appropriate imaging protocols and analyses in future clinical trials for acute ischemic stroke. This review will help researchers select appropriate imaging biomarkers among the various imaging protocols available and apply the selected type of imaging examination for each study in accordance with the academic purpose.

HACCP 인증 현황 및 발전방안 (HACCP certification status and development plan)

  • 구경민;김태웅;한선하;안영순;전예정;이제명;황수진
    • 식품과학과 산업
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    • 제54권2호
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    • pp.62-72
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    • 2021
  • HACCP 인증업체의 자율관리 능력을 제고하고 관리가 미흡한 업체 등에 대한 집중관리 등 선택과 집중을 통한 관리가 필요하다. 더불어 스마트 HACCP의 확대, 보급을 통해 HACCP 운영의 효율성과 편의성을 향상 시켜야 한다. 이처럼 HACCP 제도의 내실화와 스마트화 뿐만 아니라 동시에 적용분야를 지속적으로 발굴, 확대하는 것이 우리나라 HACCP이 나아가야할 방향이다.

Prevalence of Antibiotic Residues and Antibiotic Resistance in Isolates of Chicken Meat in Korea

  • Lee, Hyo-Ju;Cho, Seung-Hak;Shin, Dasom;Kang, Hui-Seung
    • 한국축산식품학회지
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    • 제38권5호
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    • pp.1055-1063
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    • 2018
  • The aim of study was to investigate the correlation between the level of 17 antibiotic residues and 6 antibiotic resistances of Escherichia coli isolates in chicken meats. A total of 58 chicken meats were collected from retail grocery stores in five provinces in Korea. The total detection rate of antibiotic residues was 45% (26 out of 58). Ten out of 17 antibiotics were detected in chicken meats. None of the antibiotics exceeded the maximum residue level (MRLs) in chicken established by the Ministry of Food and Drug Safety (MFDS). The most detected antibiotics were amoxicillin (15.5%), followed by enrofloxacin (12.1%) and sulfamethoxazole (10.3%). In a total of 58 chicken meats, 51 E. coli strains were isolated. E. coli isolates showed the highest resistance to ampicillin (75%), followed by tetracycline (69%), ciprofloxacin (65%), trimethoprim/sulfamethoxazole (41%), ceftiofur (22%), and amoxicillin/clavulanic acid (12%). The results of study showed basic information on relationship between antibiotic residue and resistance for 6 compounds in 13 chicken samples. Further investigation on the antibiotic resistance patterns of various bacteria species is needed to improve food safety.

국내 수산용 의약품의 사용과 관리 현황 (Administration and use of aquaculture drugs in Korea)

  • 김진우;조미영;지보영;박명애;김나영
    • 한국어병학회지
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    • 제27권1호
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    • pp.67-75
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    • 2014
  • Aquaculture drugs have used to prevent disease in aquaculture field for many years. In spite of many advantages, overdose and abuse may cause environmental pollutions and antibiotic resistances. Many countries try to protect the environment, biospecies and food safety. Recently, Korea enact laws and ordinances such as the Aquatic Animal Disease Control Act. The purpose of this act to contribute to the stable production and control system for aquatic diseases. The Maximum residue limits (MRLs) of aquaculture drugs have been established by Ministry of Food and Drug Safety (MFDS) and Drug licensing was in National Fisheries Research and Development Institute (NFRDI) by Aquatic Animal Disease Control Act. There is 750 items in aquaculture drugs and these are classified into 4 group, which is approval, necessary for prescription, unregulated and safety drug, and banned drug. MRLs of 30 items in aquaculture drug have been established by Food Sanitation Act. Future research is required to determine the suitable for abundant varied fishes of drugs for side effects and safety.

Total Diet Study: For a Closer-to-real Estimate of Dietary Exposure to Chemical Substances

  • Kim, Cho-il;Lee, Jeeyeon;Kwon, Sungok;Yoon, Hae-Jung
    • Toxicological Research
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    • 제31권3호
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    • pp.227-240
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    • 2015
  • Recent amendment on the Food Sanitation Act in Korea mandated the Minister of Food & Drug Safety to secure the scientific basis for management and reevaluation of standards and specifications of foods. Especially because the current food safety control is limited within the scope of 'Farm to Market' covering from production to retail in Korea, safety control at the plane of true 'Farm to Fork' scope is urgently needed and should include 'total diet' of population instead of individual food items. Therefore, 'Total Diet Study (TDS)' which provides 'closer-to-real' estimates of exposure to hazardous materials through analysis on table-ready (cooked) samples of foods would be the solution to more comprehensive food safety management, as suggested by World Health Organization and Food and Agriculture Organization of the United Nations. Although the protection of diets from hazards must be considered as one of the most essential public health functions of any country, we may need to revisit the value of foods which has been too much underrated by the meaningless amount of some hazardous materials in Korea. Considering the primary value of foods lies on sustaining life, growth, development, and health promotion of human being, food safety control should be handled not only by the presence or absence of hazardous materials but also by maximizing the value of foods via balancing with the preservation of beneficial components in foods embracing total diet. In this regard, this article aims to provide an overview on TDS by describing procedures involved except chemical analysis which is beyond our scope. Also, details on the ongoing TDS in Korea are provided as an example. Although TDS itself might not be of keen interest for most readers, it is the main user of the safety reference values resulted from toxicological research in the public health perspective.

Analysis for Individual-authorization of Functional Food Materials in Korea

  • Son, Chang-Gue
    • 대한한의학회지
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    • 제36권4호
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    • pp.35-41
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    • 2015
  • Objectives: This study aimed to provide basic information for the trend of individual-authorization on functional food materials in Korea to side of Korean medicine. Methods: Approval of materials for individual-authorized functional food in Korea was analyzed from 2004 to August 2015 using database from Ministry of Food and Drug Safety (MFDS), regarding the kinds of function, materials and their functional level by year. Results: Korean functional food market has rapidly grown to 1.56 trillion Won in 2014, with about 10% of annual growth rate. In particular, the increase of individual-authorized functional food is worth of notices, in detail 313 kinds of functional materials covering 31 body functions have been approved by August 2015. 15.7% of individual-authorized functional foods have used the herbal materials. This quantitative and qualitative expansion of functional foods, especially of individual-authorized functional foods, will affect the herbal drug industry negatively. Conclusion: This study figured out the current pattern of material approval for individual-authorized functional food in Korea, which would be essential in development of strategies by Korean medicine community in order to overcome such conditions.

초음파골밀도측정기 정도관리 방안제시를 위한 한국 초음파골밀도 사용현황 조사 (Survey on Usage of Korean Quantitative Ultrasound for Proposing Quantitative Ultrasound Quality Control Guideline)

  • 정윤지;김미정;이승열;이태희;성열훈
    • 대한방사선기술학회지:방사선기술과학
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    • 제41권4호
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    • pp.329-337
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    • 2018
  • This study was investigated quantitative ultrasound (QUS) usage in Korea for the QUS quality control guidelines. A total of 344 questionnaires collected from July 24th to August 25th 2017 were analyzed. Questionnaires were created through user interviews, expert group advice, literature review and field observation. As a result of the general characteristics of quantitative ultrasound holding amounted to 81.98% of clinic and 6.69% of hospitals. The main user was radio-logical technologists as 31.39%. The contact methods of the gel pad (balloon) were the most used at 56.68% and the scan region was 91.9% of calcaneus. The quantitative ultrasound quality control cycle was 67.37% when the abnormality was found in the equipment, and 63.66% when the accuracy control was implemented according to the manual. The phantoms of QUS were 34.30% of the manufacturer's own phantoms. User of QUS had never received education for quality control of quantitative ultrasound as 62.20%. This study was expected to be useful when creating detailed quality control guidelines in the future, as well as guidelines for the quality control of Korea's standard quantitative ultrasound.

식품 중 oxidized polyethylene wax 분석법 연구 및 함유량 실태 조사 (Study on the Analytical Method and Monitoring of the Oxidized Polyethylene Wax in Foods)

  • 최승현;김재민;최선일;정태동;조봉연;이진하;이근영;임호수;윤상순;이옥환
    • 한국식품위생안전성학회지
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    • 제32권4호
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    • pp.284-289
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    • 2017
  • 본 연구는 국내 미지정 피막제인 산화형 폴리에틸렌 왁스를 분석하기 위해 다양한 분석방법을 비교, 검토하였으며, 확립된 최적 분석법을 이용하여 시중 유통되는 과일 및 견과류에서 산화형 폴리에틸렌 왁스의 사용여부를 모니터링 하였다. 최적 분석법을 확립하기 위하여 산가, HT-GPC, MALDI-TOF/MS, GC-FID, FT-IR 등을 비교하였다. 산가측정 결과 산화형 폴리에틸렌 왁스를 첨가한 시료와 첨가하지 않은 시료 모두 산가가 1.12 mg KOH/g로 산가의 변화가 나타나지 않아 산가를 이용한 식품 중 산화형 폴리에틸렌 왁스의 분석은 어려울 것으로 판단되었으며, HT-GPC분석은 표준물질의 분산도 값이 약 3.4로 확인되었으며, GPC를 이용한 분석은 실험실간 낮은 재현성과 컬럼 등 분석조건에 따른 결과 값이 달라질 수 있기 때문에 분자량의 분산도만으로 식품 중 산화형 폴리에틸렌 왁스의 분석은 어려울 것으로 판단되었다. MALDI-TOF/MS 분석은 700~2,000 m/z에 peak가 관찰되었지만, 산화형 폴리에틸렌 왁스 성적서에 적혀있는 분자량 범위인 2,700~2,800 m/z와 큰 차이를 보여, MALDI-TOF/MS를 이용한 분석 역시 어려울 것으로 판단되었다. GC-FID를 이용한 지방산 분석결과 산화형 폴리에틸렌 왁스 표준물질에서 과일 및 견과류에서 흔히 볼 수 없는 지방산인 C11:0, C15:1 지방산이 검출되었지만, 제외국 허용기준으로 첨가하여 분석하였을 때 관찰되지 않고, 고농도를 첨가할 경우에만 피크가 관찰되어 GC-FID를 이용한 분석은 어려울 것으로 판단되었다. FT-IR 분석결과 코팅된 견과류 시료와 코팅되지 않은 견과류 시료를 비교하였을 때 코팅된 시료에서 산화형 폴리에틸렌 왁스 표준물질의 spectrum과 일치하는 spectrum을 나타내어, 식품 중 산화형 폴리에틸렌 왁스의 분석은 FT-IR로 분석이 가능함을 확인하였다. 확립된 FT-IR 분석법을 이용하여 국내외 대형마트에서 구입한 111건의 과일 및 견과류를 분석한 결과 산화형 폴리에틸렌 왁스를 사용한 시료가 없음을 확인하였다.

한국인의 총 당류 섭취실태 평가: 2008~2011년 국민건강영양조사 자료를 이용하여 (Dietary total sugar intake of Koreans: Based on the Korea National Health and Nutrition Examination Survey (KNHANES), 2008-2011)

  • 이행신;권성옥;연미영;김도희;이지연;남지운;박승주;연지영;이순규;이혜영;권오상;김초일
    • Journal of Nutrition and Health
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    • 제47권4호
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    • pp.268-276
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    • 2014
  • 우리 국민의 총 당류 섭취량 평가를 위해, 2008~2011년 국민건강영양조사 영양조사부문에서 24시간 회상법을 활용한 식품섭취량 조사에 응답한 33,745명 (1세 이상)의 식품섭취량 자료를 통합하여 분석자료로 활용하였으며, 미국 USDA의 SR 25와 식품의약품안전처의 1,136종 식품의 당류 함량 분석자료, 그리고 가공식품의 영양성분표시 내용 등을 활용하여 총 3,006종의 식품에 대한 총 당류 함량 DB를 구축하였다. 상기한 섭취량 데이터와 연계하여 우리 국민의 당류섭취량, 총 당류 에너지섭취비율과 주요 당류 급원식품을 분석한 결과, 우리 국민의 총 당류 섭취량은 1인 1일 평균 61.4 g이었으며, 전체 섭취 에너지의 12.8%를 차지하였다. 이 중 가공식품으로부터 섭취된 당류는 35.0 g으로 총 에너지의 7.1%에 해당되었다. 연령층에 따라서는 청소년층 (12~18세, 69.6 g)과 청년층 (19~29세, 68.4 g)의 총 당류 섭취량이 다른 연령층에 비해 높았으며, 가공식품을 통한 총 당류 섭취비율도 이들 연령층에서 가장 높은 것으로 나타났다. 가공식품을 통한 총 당류 섭취량의 주요 급원식품은 설탕, 탄산음료, 커피, 빵류, 과일 채소 음료류 등 이었으며, 가공식품을 통한 총 당류 섭취량에 대한 음료류의 기여율은 평균 18.1%이었으나 19~29세에서는 24.9%에 달할 만큼 음료류가 부각되었다. 비록 우리국민의 현재 총 당류 섭취량이 한국영양학회의 권고 수준인 총 에너지 섭취량의 10~20%를 벗어나지는 않았으나, 상대적으로 높은 총 당류 섭취수준을 보인 청소년과 청년층의 식생활에 대한 관리, 특히 음료류 섭취에 대한 관리가 필요하다는 것이 드러났으며, 우리 국민의 보다 정확한 당류섭취량 파악이 가능하도록 당의 종류별 함량 데이터베이스 구축과 함께 생애주기에 따라 차별화 된 적절한 당류 저감화 정책이 마련되고 시행되어야 할 것으로 사료된다.

국내 허가사항에 반영된 약물 유전정보 분석 (Analysis of Pharmacogenetic Information in Korea Drug Labels)

  • 이미진;김수경;이정;곽혜선;최경희
    • 한국임상약학회지
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    • 제31권1호
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    • pp.21-26
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    • 2021
  • Background: Pharmacogenomics is the study of how genetic mutations in patients affect their response to drugs. Pharmacogenomic studies aim to maximize drug effects and minimize adverse drug events. The Food and Drug Administration and the European Medicine Agency published guidelines for pharmacogenetics in 2005 and 2006, respectively; the Korean Ministry of Food and Drug Safety followed suit in 2015. Methods: This study analyzed pharmacogenomic information in the Korean Ministry of Food and Drug Safety's integrated drug information system to evaluate whether domestic pharmaceutical products reflect the current research on pharmacogenomic differences. Results: In June 2020, the Korean pharmacogenomic database contained genomic data on 90 compounds. Of these, 45 compounds were classified as "Antineoplastic and immunomodulating agents." The other 45 non-antineoplastic agents were in the following categories: Anti-infectives, Mental & behavior disorder, Hormone & metabolism related diseases, Cardiovascular system, Skin & subcutaneous tissue disease, Genito-urinary system and sex hormones, Blood and blood forming organs, Nervous system, Alimentary tract and metabolism, Musculo-skeletal system, and Other conditions including the respiratory system. In addition, 30 additives unrelated to the main ingredient were associated with genetic precautions. Conclusion: This study showed that antineoplastic and immunomodulating agents accounted for half the drugs associated with pharmacogenetic information. For antitumor and immunomodulatory drugs, genomic tests were recommended depending on the indication; this was in contrast to genomic testing recommendations for non-antineoplastic medications. Genomic tests were rarely requested or recommended for non-antineoplastic medications because the relationships between genotype and efficacy among those drugs were relatively weak.