• 제목/요약/키워드: drug labeling

검색결과 85건 처리시간 0.028초

한국 의약품부작용보고원시자료를 활용한 알파차단제의 이상사례 실마리정보 비교 분석 (Signal Detection of Alpha-adrenoceptor Antagonist using the KIDS-KAERS database (KIDS-KD))

  • 구현지;권준영;최재혁;유승훈;박세원;정경혜;정선영
    • 한국임상약학회지
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    • 제33권2호
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    • pp.86-96
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    • 2023
  • Background: Using KIDS-KAERS database (KIDS-KD) from 2016 to 2020, the aim is to investigate signals of adverse events of alpha-adrenoceptor antagonists and to present adverse events that are not included in the precautions for use when marketing approval. Methods: This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of alpha-adrenoceptor antagonists, such as terazosin, doxazosin, alfuzosin, silodosin, and tamsulosin. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). Detected signals were compared with product labeling and the European Medicines Agency-Important Medical Events list. Results: Out of the total number of 408,077 reports for adverse events, 6,750 cases were reported as adverse events of alpha-adrenoceptor antagonists. Dizziness, mouth dryness, hypotension postural, and oedema peripheral are identified as common adverse events of five alpha-adrenoceptor antagonists and are typically listed on drug labels. However, new signals were detected for pneumonia, chronic obstructive airway disease, eye diseases such as glaucoma and cataracts, fracture, and ileus of tamsulosin that were not previously listed on the drug labels in Korea. Conclusions: This study identified signals related to adverse drug reactions of alpha-adrenoceptor antagonists and presented serious adverse events, suggesting new adverse reactions to be aware of when using alpha-adrenoceptor antagonists.

PCR을 이용한 식품 중 알레르기 유발물질 검출법 개발 (Development of PCR Method for Rapid Detection of Allergic Materials in Foods)

  • 박용춘;김미라;신준호;김규헌;이재황;조태용;이화정;이상재;한상배
    • 한국식품위생안전성학회지
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    • 제28권2호
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    • pp.124-129
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    • 2013
  • 본 연구에서는 분자생물학적 방법을 통한 알레르기 유발 원재료 확인을 위해 PCR방법의 최적 조건을 구축하였다. 가공식품에서 알레르기 원료성분 확인을 위하여 200bp 내외의 PCR 산물을 생성할 수 있는 종특이 프라이머를 설계하거나 선행연구사업 결과를 활용하였다. 대상 원료로는 국내 식품알레르기 표시대상인 난류, 우유, 메밀, 땅콩, 대두, 밀, 고등어, 게, 새우, 돼지고기, 복숭아 및 토마토와 제외국에서 알레르기 유발 성분으로 규정하고있는 아몬드, 참깨를 포함하여 총 14종을 대상으로 하였다. 특이 프라이머를 사용하여 PCR 한 결과 난류, 우유, 메밀, 땅콩, 대두, 밀, 고등어, 게, 새우, 돼지고기, 복숭아, 토마토, 아몬드 및 참깨로부터 각각 281, 131, 138, 120, 118, 127, 211, 174, 231, 138, 174, 132, 103 및 220bp의 특이 밴드를 확인하였으며 상호간의 비 특이적 밴드는 검출되지 않았다. 본 연구에서 확립한 알레르기 유발 원재료 검출법은 식품의 부정확한 표시나 가공식품의 제조과정 중 알레르기 유발물질의 비의도적 혼입 등으로부터 소비자를 보호하고 향후 수출 제품에 있어서 정확한 알레르기 유발원재료 표기에 활용이 가능할 것으로 판단된다.

압타머 광학 바이오센서 (Aptamer-based optical switch for biosensors)

  • 이주운;조정환;조은정
    • 분석과학
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    • 제27권3호
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    • pp.121-139
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    • 2014
  • In this review, we will discuss aptamer technologies including in vitro selection, signal transduction mechanisms, and designing aptamers and aptazyme for label-free biosensors and catalysts. Dye-displacement, a typical label-less method, is described here which allows avoiding relatively complex labeling steps and extending this application to any aptamers without specific conformational changes, in a more simple, sensitive and cost effective way. We will also describe most recent and advanced technologies of signaling aptamer and aptazyme for the various analytical and clinical applications. Quantum dot biosensor (QDB) is explained in detail covering designing and adaptations for multiplexed protein detection. Application to aptamer array utilizing self-assembled signaling aptamer DNA tile and the novel methods that can directly select smart aptamer or aptazyme experimentally and computationally will also be finally discussed, respectively.

기능성 Microspheres의 합성 및 생의학적 응용 (Synthesis of Functional Microspheres and Biomedical Applications)

  • 김중현;김우식
    • 대한의용생체공학회:학술대회논문집
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    • 대한의용생체공학회 1993년도 춘계학술대회
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    • pp.7-14
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    • 1993
  • Nowadays, microspheres are expected to be applied to biomedical areas and many studies are being performed. For biomedical applications, many kinds of microspheres were synthesized by emulsion polymerization, emulsifier-free emu]sion polymerization, and emulsifier-free emulsion polymerization with ionic surface-active comonomers. Further synthesis techniques about microencapsulation and magnetic microspheres are introduced. Among the practical applications of microspheres, some interesting subjects are introduced. These include solid-phase immunoassays, labeling and identification of lymphocyte populations, extracorporeal and hemoperfusion systems, drug delivery systems, and immunomagnetic cell separation. In addition, basic theories, problems and research trends are also introduced.

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고령친화 의료기기의 안전관리방안 연구 (A Study on Safety Management for Senior-Friendly Medical Devices)

  • 임경민;송동진
    • 대한의용생체공학회:의공학회지
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    • 제39권6호
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    • pp.256-267
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    • 2018
  • The number of items and the market size of the senior-friendly medical devices are rapidly increasing, and it is necessary to come up with a safety management plan for senior-friendly medical devices. We searched and analyzed the definition and policy of senior-friendly medical device, and classified medical device items of the Ministry of Food and Drug Safety, calculated market sizes and manufacturing export import results by classification, and investigated the current state of senior-friendly industry and the fields of its culture. In order to prepare a safety management plan, we reduce the number of items that need to be managed intensively by extracting 69 items for administration, that are substantially harmful to the elderly. As specific safety management plans of items for administration, we propose plans for introductions of readability-enhanced labeling, QR codes for cautions and manuals, universal design mandatory, UDI code system with considering a balanced viewpoint of the industry development.

Minireview on Recent Antibody-Related NMR Studies

  • Jang, Jinhwa;Kim, Ji-Hun
    • 한국자기공명학회논문지
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    • 제24권4호
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    • pp.129-135
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    • 2020
  • In a relatively short period, monoclonal antibodies have made dramatic success as therapeutics for various diseases such as cancers and autoimmune diseases and become an important development items for many pharmaceutical companies. In order to develop antibody drug, it is important to investigate the structural characteristics of both antibody and antigen. NMR studies on antibody are extremely challenging due to big huddles such as a big size of protein and isotope labeling, nevertheless, several studies have been reported in 10 years. Here, we analyzed 95 papers dealing with antibody-related NMR studies reported in recent 10 years. We categorized papers into 3 types: 1) structural characterization of antibody, 2) structural characterization of antigen using antibody, 3) amyloidosis caused by fragment of antibody. This work would shed new light on antibody-related NMR studies.

Perception of sugar reduction, nutrition education, and frequency of snacking in children by the self-perceived sweet dietary habits of mothers in Busan

  • Yeon, Jee-Young;Lee, Soon-Kyu
    • Nutrition Research and Practice
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    • 제10권5호
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    • pp.546-554
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    • 2016
  • BACKGROUND/OBJECTIVES: The aim of this study was to investigate the perception of sugar reduction, nutrition education, and frequency of snacking in children according to the self-perceived dietary preferences for sweet taste by mothers in Busan. SUBJECTS/METHODS: A total of 277 mothers were surveyed, and their perceptions of sugar reduction and the frequency of snacking in children were assessed using a questionnaire. The subjects were classified into either a sweet (n = 91) or an unsweet (n = 186) group according to their self-perceived preferences for a sweet taste. RESULTS: In the sweet group, the results for sweet products were sweetened ice (86.8%), confectionery (74.7%), processed milk (73.6%), carbonated beverages (71.4%), and fermented milk (53.9%). In the unsweet group, the results were sweetened ice (88.7%), carbonated beverages (78.5%), processed milk (75.8%), confectionery (69.4%), and fermented milk (50.5%). The necessity of sugar intake reduction was high in both groups (sweet = 89.0%, unsweet = 82.8%). Beverage purchases after identifying the nutrition labeling was significantly lower in the sweet group than in the unsweet group (P < 0.05). The reasons for the beverage purchases instead of water were "habitually" (50.5%) and "like sweet taste" (25.3%) in the sweet group (P < 0.01). Snacking in children was significantly higher in the sweet group based on the increased frequencies of carbonated drinks (P < 0.01), fast food (P < 0.001), candy and chocolate (P < 0.05), crackers (P < 0.01), ramen (P < 0.01), and fish paste/hotdogs (P < 0.01). The frequency of purchase education after identifying the nutrition labeling was significantly lower in the sweet group than in the unsweet group (P < 0.01). CONCLUSIONS: These findings suggest that a perception of sugar reduction and practical nutrition education aimed at reducing the sugar intake are necessary to improve dietary habits.

Assessment of Masks Used by Healthcare Workers: Development and Validation of a Mask Qualitative Assessment Tool (MQAT)

  • Gharibi, Vahid;Cousins, Rosanna;Mokarami, Hamidreza;Jahangiri, Mehdi;Keshavarz, Mohammad A.;Shirmohammadi-Bahadoran, Mohammad M.
    • Safety and Health at Work
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    • 제13권3호
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    • pp.364-371
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    • 2022
  • Background: Respiratory masks can provide healthcare workers with protection from biological hazards when they have good performance. There is a direct relationship between the visual specifications of a mask and its efficacy; thus, the aim of this study was to develop tools for qualitative assessment of the performance of masks used by healthcare workers. Methods: A mixed-methods design was used to develop a qualitative assessment tool for medical face masks (MFM) and particle filtering half masks (PFHM). The development of domains and items was undertaken using observation and interviews, the opinions of an expert panel, and a review of texts and international standards. The second phase evaluated the psychometric properties of tools. Finally, the validated Mask Qualitative Assessment Tools (MQAT) were used to assess six samples from 10 brands of the two types of masks. Results: MQAT-MFM and MQAT-PHFM shared 42 items across seven domains: "cleanliness," "design," "marking, labeling and packaging," "mask layers," "mask strap," "materials and construction," and "nose clip." MQAT-MFM included one additional item. MQAT-PHFM included another nine items associated with an eighth "Practical Performance" domain, and the valve version had another additional "Exhalation Valve" domain and six items. The evaluation indicated 80% compliance for MFM and 71% compliance for PFHM. "Marking, labeling and packaging" and "Layers" were associated with the least compliance in both types of masks and should be checked carefully for defining mask quality. Conclusion: MQAT can be used for immediate screening and initial assessment of MFM and PHFM through appearance, simple tools, and visual inspection.

이온크로마토그래프를 이용한 조제유류 및 영아용·성장기용 조제식 중 콜린 함량 분석법 연구 (Establishment of Choline Analysis in Infant Formulas and Follow-up Formulas by Ion Chromatograph)

  • 황경미;함현숙;이화정;강윤정;윤혜성;홍진환;이현영;김천회;오금순
    • 한국식품위생안전성학회지
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    • 제32권5호
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    • pp.411-417
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    • 2017
  • 본 연구는 "축산물의 가공기준 및 성분규격"에 기준규격은 설정되어 있지 않으나, 국제 기준과의 조화를 위해 콜린의 분석법을 마련하고자 수행하였다. 조제유류에 함유된 콜린 함량 분석을 위해 IC를 이용한 분석법을 확립하고 시중에 유통 중인 제품을 대상으로 적용성을 검토하였다. 콜린 표준품을 이용하여 IC를 이용한 기기분석조건을 확립하고 시료중의 콜린을 추출하여 분석하였다. 분석법 검증은 특이성, 직선성, 검출한계 및 정량한계, 정확성, 정밀성에 대해 수행되었다. 0.5~10 mg/L의 농도범위에서 $R^2=0.999$ 이상의 우수한 직선성을 확인할 수 있었으며, LOD와 LOQ는 각각 0.14, 0.43 mg/L였다. CRM (NIST SRM 1849a) 및 표준물질 첨가법을 이용하여 정확성을 검토하였으며, CRM에서 95%, 조제분유에서 90~91%, 조제우유에서 81~98%의 회수율을 확인할 수 있었다. 정밀성을 검토한 결과 시료 채취량에 따른 반복성은 RSD값이 조제분유 0.4~2.0%, 조제우유 0.5~1.5%, 영아용조제식 0.6~1.0%, 성장기용조제식 0.8~2.7%,로 확인하였으며, 실험일자에 따른 재현성은 조제분유 3.1%, 조제우유 2.5%, 영아용조제식 4.8%, 성장기용조제식 2.7%로 확인하였다. 본 연구에서 확립된 분석법을 적용하여 조제분유 11건, 조제우유 2건, 성장기용조제분유 9건, 영아용조제식 2건, 성장기용조제식 8건 등 국내 유통 중인 조제유류 및 영아용 성장기용조제식 등 32건에 대해 적용성 검토를 실시한 결과 전체 시료에서 분석이 용이하였으며, 모두 표시기준에 적합함을 확인하였다.

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

  • 홍진;임동길;김미경;박경식;윤태형;노기미;정자영
    • 한국식품위생안전성학회지
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    • 제25권2호
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    • pp.162-169
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    • 2010
  • 식품위생법개정에 의한 음식점 식육 원산지 표시제가 시행됨에 따라 표시제도의 정착을 위해 마련한 과학적 한우판별 시험법을 이용하여 소고기 원산지 표시제에 대한 실패를 전국적 규모로 점검하였다. 본 연구에 사용한 한우판별시험법은 앞선 사업에서 검증된 90개의 한우판별용 SNP 바이오마커를 이용한 시험방법으로 소고기원산지표시제의 제도정착에 큰 기여를 하고 있다. 2009년도 식품안전관리지침에 계획도니 음식점 소고기 원산지 표시제 시행 대상 음식점으로는 구이용 쇠고기 판매 음식점으로서 영업장 면접이 $100m^2$이상인 곳 가운데 서울지역 48개 시료 및 지방 168개 시료 등 총 216건에 대하여 원산지 표시실태 모니터링 검사를 실시하였으며, 그 결과 총 검체의 1.3% (3건/216건)가 허위표시임이 파악되었다. 이는 2008년도의 모니터링 검사를 통하여 확인한 허위표시 비율인 5.14%에 비해 감소한 결과로 "음식점식육원산지표시제"가 점차 정착되고 있는 것으로 판단된다. 또한, 한우판별시험법이 마련되기 전 실시했던 음식점 소고기 원산지 표시에 대한 모니터링 실시결과 2005년 34.0%, 2006년 30.1%으로 나타난 반면 한우판별시험법이 확립된 후 모니터링 결과는 2007년도 3.2%, 2008년도 5.14%으로 나타나 한우판별시헙법의 확립이 음식점 소고기 원산지 표시제에 큰 기여를 하고 있음을 증명해 주고 있다.