• 제목/요약/키워드: FDA system

검색결과 100건 처리시간 0.027초

동결-융해된 돼지난포란의 생존성에 대한 항동해제와 평형시간의 영향 (Effects of Cryoprotectants and Equilibration Time on the Viability of Frozen-thawed Porcine Oocytes)

  • 이장희;김창근;박충생
    • 한국수정란이식학회지
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    • 제12권3호
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    • pp.315-324
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    • 1997
  • This study was undertaken in an effort to develop a cryopreservation system of immature and mature porcine oocytes. For this aim, the experiments were designed to examine the effect of cryoprotectants and equdibration time on the viability of frozen-thawed oocytes by using trypan blue(TB) and fluorescene diacetate(FDA) test. The viability of frozen immature oocytes evaluated by TB test was slightly higher than that of frozen mature oocytes. The viability(25.O%) after IVM of frozen-thawed immature oocytes greatly decreased that(42.9%) of oocytes just after thawing, but it was higher than frozen-thawed mature oocytes(15.8%). When immature oocytes were equilibrated for 10, 20 and 30 minutes before freezing the oocyte viability was 20.0, 31.3 and 42.9%, respectively. There was a tendency for long equilibration before oocyte freezing to be more effective for the immature oocytes and a short equilibration time for mature oocytes. Although there was no difference in viability index of frozen oocytes hetween the viability test methods, the index of TB test was slightly higher than that of FDA test. The viability(FDA test) of frozen-immature oocytes with 3 different crtoprotectants was 22.2% for propylene glycol(PG), 9.3% for polyehtylene glycol(PEG) and 65.6% for PG+PEG, in which PG+PEG was more protective against freezing effect.

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HPLC-UVD를 이용한 농산물 중 pyrifluquinazon 잔류시험법 개발 및 검증 (Development and validation of analytical methods for pyrifluquinazon residues determination on agricultural commodities by HPLC-UVD)

  • 도정아;권지은;김미라;이은미;국주희;조윤제;장문익;권기성;오재호
    • 분석과학
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    • 제26권3호
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    • pp.174-181
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    • 2013
  • Pyrifluquinazon은 quinazoline 계통의 살충제로 진딧물, 흰파리 등 해충에 대해 음식섭취를 조절하는 신경계 또는 내분비계에 작용하여 섭식행동을 제어하고 또한 식물조직에 추가적 손상을 방지, 식물체 바이러스 확산을 막는 역할을 한다. 국내에는 2012년 사과와 배에 신규 사용등록되어 식품의약품안전처에서 잔류허용기준을 설정하였다. 본 농약은 분자량이 464.3으로 큰 편이며, 증기압이 낮아 분석을 위한 기기로 HPLC-UVD를 선택하여 잔류허용기준 준수여부 확인을 위한 시헙법을 확립하였다. 추출용매는 간섭물질의 추출이 비교적 적은 acetonitrile을 사용하였으며, pyrifluquinazon의 Log $P_{ow}$값이 3.12로 극성에 가까운 물리화학적 특성을 감안하여 액-액 분배를 위한 용매로 dichloromethane을 사용하였다. 간섭물질 제거를 위한 clean-up과정에서는 silica 카트리지를 사용하였고, acetone으로 용출하여 최적의 정제조건을 확립하였다. 분석 결과 회수율은 70~120%로 나타났으며, 분석오차는 10% 미만, 실험실간 편차 ($RSD_R$(%)) > 0.01 mg/kg, ${\leq}$0.1 mg/kg 범위에서 3.40~15.4%로 코덱스 가이드라인 기준에 적합함을 확인 하였다. 또한 본 시험법의 재현성 및 선택성을 추가로 확보할 수 있도록 LC-MS를 통한 정성시험법을 추가로 확립하였다. 본 시험법은 신규 등록된 pyrifluquinazon 분석을 위한 신속 정확한 공정 시험법으로 식품공전에 등재되어 활용되고 있다.

기능성식품 인체적용시험 제도 비교 (Human Studies on Functional Foods: How They Are Regulated)

  • 김주희;김지연;원혜숙;권혜진;권혜영;정혜인;권오란
    • Journal of Nutrition and Health
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    • 제43권6호
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    • pp.653-660
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    • 2010
  • Along with the steady growth of health functional food (HFF) markets, research evaluating the human effects of HFF has been expanding. In this study, we investigated the regulatory and management system of human study on HFF in the USA, Japan and UK, and the Korean domestic regulations on HHF, medicines, medical devices, cosmetics and biotechnology in order to improve the domestic management system. In these four countries, institutional review board (IRB) or research ethics committee (REC) approvals are required for on human study of HHF, but regulatory and management systems differ from country to country. In the USA, human studies on HFF for structure/function claims do not require the FDA's prior approval but clinical trials of the disease treatment effects of HHF require prior approval from the FDA. In the USA, IRBs are managed by the Department of Health and Human Services (DHHS) rather than the FDA, and IRBs in those institutions which would execute the clinical trials requiring prior approval from the FDA or human studies funded by the USA federal government are required to be registered on the DHHS. In the UK, although the government does not require prior approval of human study, authorized RECs managed by the National Research Ethics Service (NRES) and other independent RECs review the human study. In Japan, human study for HFF must conform with "Ethical guidelines for epidemiological research" and IRB registration has not been required. In Korean domestic regulations, the responsibilities, compositions, functions and operations of IRBs on medicines, medical devices and biotechnology are legally specified, but not those of IRB on HHF. These foreign statuses for the management of human study on HFF and comparisons with Korean regulations are expected to be used as basic data to improve the domestic legal system.

비용 효율적인 유연 디스플레이용 무색 투명 폴리이미드 필름 제작 (Cost-efficient Fabrication of Colorless and Optically Transparent Polyimide Film for Flexible Displays )

  • 조다운;김지호;오충석
    • 반도체디스플레이기술학회지
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    • 제22권1호
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    • pp.33-38
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    • 2023
  • As the demand for large flexible displays such as tablet computers continues to rise, there is an increasing need for cost-efficient colorless and optically transparent polyimide film that can meet the desired performance, particularly optical transmittance. In this study, we investigated a detailed procedure for achieving optimal optical transmittance using two different combinations of monomers: 6FDA+BAPB and 6FDA+BPA+TFDB. We employed a design of experiment method to systematically synthesize polymers, allowing for the optimization of optical transmittance. In addition, we were able to achieve uniform thickness in the films by using a doctor blade. By comparing the price and optical transmittance of four different monomer combinations, we obtained fundamental data on the production of polyimide films that can be customized to meet the specific price and performance requirements of manufacturers. This approach enables users to select the most suitable polyimide film based on their desired price and performance parameters while achieving optimal optical transmittance.

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인터넷 뱅킹의 사용자 인증을 위한 얼굴인식 시스템의 설계 (Design of Face Recognition System for Authentication of Internet Banking User)

  • 배경율
    • 지능정보연구
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    • 제9권3호
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    • pp.193-205
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    • 2003
  • 본 논문에서는 인터넷 뱅킹의 사용자 인증에 있어 더 강인성(Robustness)을 갖춘 인증 시스템을 위해서 생체의 특징을 이용해 신분을 증명 또는 인증하는 생체인식 기술 중 지문이나 장문, 정맥, 홍채를 이용한 인식과 같이 장비에 접촉해야만 것과 달리 거부감이 없고, 별도의 전문 장비를 필요로 하지 않아 일반 대중들에 쉽게 접근할 수 있는 얼굴인식을 이용해 인증 시스템의 설계 및 구현을 제안한다. 얼굴인식 알고리즘은 얼굴 특징을 분석하는 방식에 따라 PCA (Principal Component Analysis), ICA (Independent Component Analysis), FDA (Fisher Discriminant Analysis) 등이 발표되어 있다. 이들 중 가장 기본적인 알고리즘이라 할 수 있는 PCA를 이용해 얼굴 특징을 분석하고 암호화된 형태의 생체 데이터를 전달해 분석한 결과를 원격지에 신속하고 정확하게 송수신할 수 있는 인터넷 뱅킹에서의 사용자 인증을 위한 얼굴인식 시스템의 설계 방법을 제안한다.

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Hazard prediction of coal and gas outburst based on fisher discriminant analysis

  • Chen, Liang;Wang, Enyuan;Feng, Junjun;Wang, Xiaoran;Li, Xuelong
    • Geomechanics and Engineering
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    • 제13권5호
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    • pp.861-879
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    • 2017
  • Coal and gas outburst is a serious dynamic disaster that occurs during coal mining and threatens the lives of coal miners. Currently, coal and gas outburst is commonly predicted using single indicator and its critical value. However, single indicator is unable to fully reflect all of the factors impacting outburst risk and has poor prediction accuracy. Therefore, a more accurate prediction method is necessary. In this work, we first analyzed on-site impacting factors and precursors of coal and gas outburst; then, we constructed a Fisher discriminant analysis (FDA) index system using the gas adsorption index of drilling cutting ${\Delta}h_2$, the drilling cutting weight S, the initial velocity of gas emission from borehole q, the thickness of soft coal h, and the maximum ratio of post-blasting gas emission peak to pre-blasting gas emission $B_{max}$; finally, we studied an FDA-based multiple indicators discriminant model of coal and gas outburst, and applied the discriminant model to predict coal and gas outburst. The results showed that the discriminant model has 100% prediction accuracy, even when some conventional indexes are lower than the warning criteria. The FDA method has a broad application prospects in coal and gas outburst prediction.

식품의약품안전청 약물유해반응 보고자료 분석 (Analysis of the Korea Food and Drug Administration Adverse Drug Reaction Reports)

  • 유기연;이숙향
    • 한국임상약학회지
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    • 제21권2호
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    • pp.138-144
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    • 2011
  • In order to minimize such adverse drug reactions, governments and international organs have been on the watch for them. Also in South Korea, a system has been established in order that adverse drug reactions may be reported to Korea Food and Drug Administration(KFDA). This study is to analyze drugs to cause adverse reactions, the adverse reactions and patients concerned on the authority of the data of Korea FDA, which is expected to be the preliminary data on preventable adverse reactions. This study was conducted on the 74,037 cases of adverse drug reactions reported to Korea FDA between January 2007 and June 2010. Fentanyl, iopromide and tramadol caused adverse reactions with high frequencies. Oseltamivir showed a high frequency between 2009 and 2010 due to the influence of the new influenza A. Also, OTC drugs accounted for approximately 5% of the adverse reactions. In 2009, adverse drug reactions remarkably increased (2,106 cases; 10.1%) in infants and children due to the new influenza-A(H1N1). The patients aged between 31 and 64 accounted for approximately 55% during the given period. There was no significant intergender difference. In relation to regions, the adverse reactions most frequently occurred in the gastrointestinal system and the integumentary system for three and half years. In addition to anticancer drugs and immunosuppressive drugs that are known to cause adverse reactions frequently, not a few of OTC drugs and external preparations caused such reactions. In particular, the drugs containing specific ingredients caused adverse reactions more frequently than others from 2007 until the first half of 2010. It is advisable for prescribers to acquaint themselves with such adverse reactions and to prescribe drugs other than them. They also have need to sensibly cope with adverse drug reactions just in case they have no substitute drugs. In addition, patients also need to be trained to understand possible adverse reactions in order that they can sensibly accommodate them or choose healthcare services. The results of this study are expected to be helpful to minimize adverse drug reactions.

6FDA-p-TeMPD 폴리이미드 비대칭막 제조에서 용매와 비용매가 막구조에 미치는 영향 (The Effects of Solvent and Nonsolvent on Asymmetric Membrane Structure of 6FDA-p-TeMPD Polyimide)

  • 박노춘;김건중;남세종
    • 멤브레인
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    • 제8권3호
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    • pp.157-169
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    • 1998
  • 폴리이미드(6FDA-p-TeMPD) 비대칭막을 습식 상분리법으로 제조하는데 있어서 그 구조에 미치는 용매 (DMAc, NMP, 1,4-dioxane)와 비용매($H_2O$, Methanol, n-hexane)의 영향을 고찰하였다. 고분자/용매/비용매 분리 속도를 예측함으로써 생성된 비대칭막의 구조를 해석하였다. 용해도 곡선이 용매-고분자 축에 가깝고, 응결값이 작으며, 광투과도가 즉시 감소하고, 용해도 계수차가 $\Delta \delta_{S-NS} > \Delta \delta_{P-NS} > \Delta \delta_{P-S}$ 순이면 생성막은 고분자 결절의 불연속 결집속에 finger-like pore가 형성되었다. 용해도 곡선이 용매-고분자 축에서 멀고, 응결값이 크며, 상분리 시간이 길고, 용해도 계수차 $\Delta \delta_{i-j}$$\Delta \delta_{P-NS} >(\Delta \delta_{S-NS} < > \Delta \delta_{P-S})$ 일때, 생성되는 막은 미소 고분자 결절구가 치밀하게 응집된 표피가 있으며, 고분자 연속상 스폰지층에 macropore가 발달되었다. 용해도 곡선이 용매-고분자 축으로부터 멀리 떨어지고, 응결값이 대단히 크며, 상분리 시간이 길고, 용해도 계수차 $\Delta \delta_{i-j}$$\Delta \delta_{S-NS} > (\Delta \delta_{P-NS}$\lessgtr$)\Delta \delta_{P-S}$인 경우는 고분자 미소 결절의 두터운 응집층과 다음에 성근 결절응집층이 나타났다.

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The Value of Tumor Treating Fields in Glioblastoma

  • Zhang, Chaochao;Du, Jianyang;Xu, Weidong;Huang, Haiyan;Gao, Li
    • Journal of Korean Neurosurgical Society
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    • 제63권6호
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    • pp.681-688
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    • 2020
  • Glioblastoma (GBM) is one of the most common tumors of the central nervous system, which is the most lethal brain cancer. GBM treatment is based primarily on surgical resection, combined with radiotherapy and chemotherapy. Despite the positive treatment, progression free survival and overall survival were not significantly prolonged because GBM almost always recurs. We are always looking forward to some new and effective treatments. In recent years, a novel treatment method called tumor treating fields (TTFields) for cancer treatment has been proposed. TTFields devices were approved by the Food and Drug Administration (FDA) for adjuvant treatment of recurrent and newly diagnosed GBMs in 2011 and 2015, respectively. This became the first breakthrough treatment for GBM in the past 10 years after the FDA approved bevacizumab for patients with relapsed GBM in 2009. This paper summarized the research results of TTFields in recent years and elaborated the mechanism of action of TTFields on GBM, including cell and animal experimental research, clinical application and social benefits.

Challenges in the Toxicological(Mutagenic and Teratogenic)/Environmental methods under the GLP system

  • Andrson, D.
    • 한국환경독성학회:학술대회논문집
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    • 한국환경독성학회 2002년도 추계국제학술대회
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    • pp.107-116
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    • 2002
  • GLP regulations were initially “promulgated to address assuring the validity of data in the wake of investigations by EPA and FDA during the mid -1970's which revealed that some studies submitted to the agencies had not been conducted in accordance with acceptable laboratory practices.” [1] In the early 1970s, results of an investigation by the FDA in about 40 laboratories revealed many cases of badly managed studies, poor training of personnel and some cases of deliberate fraud. The general findings were that there were poorly trained study directors and study personnel, poorly designed protocols, protocols not followed, procedures not conducted as described, raw data badly collected, data not correctly identified, data without traceability, data not verified and approved by responsible persons, lack of standardised procedures, poor animal husbandry, inadequate characterisation of test items and test systems, inadequate resources, equipment poorly calibrated or otherwise qualified, reports not sufficiently verified, not an accurate account of the actual study, not a proper reflection of raw data and inadequate archiving of data. These problems are not just past history, since they resurface time and time again, even in quite recent times as the experience of GLP inspectors shows [1]. The GLPs specify minimum practices and procedures in order to ensure the quality and integrity of data submitted in accordance with a regulatory requirement

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