• 무역학회지
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• 제48권3호
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• pp.131-150
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• 2023

본 연구는 한국 바이오헬스 산업에 대한 미국의 수입거부(Import Refusals) 대응 방안 모색을 목적으로 한다. 이를 위해 수입거부 품목과 유형에 대한 정보가 포함된 한국무역협회 통관거부사례 데이터베이스를 활용하여 팬데믹 시기의 동향 분석을 시행하였으며, FDA 위반코드(Violation Code)에 따라 거부사유까지 분석하였다. 추가적으로 단위거부율(URR)의 측정을 통해 수입거부 대응 수준도 파악하였다. 분석 결과, 한국 바이오헬스 산업에 대한 미국의 주요 수입거부 품목은 과거 콘택트렌즈에서 코로나-19 이후 진단키트와 의약품으로 확대된 것으로 나타났으며, 주요 수입거부 사유는 의료기기와 의약품 관련법의 규정 미준수와 제품 및 시설에 대한 FDA의 미승인으로 확인되었다. 한편 바이오헬스 주요 품목의 단위거부율은 산업 평균보다 높게 측정되어 미국 수입거부 대응 수준이 낮은 것으로 파악되었다. 또한 FDA 위반코드에 따라 품목별 수입거부 사유를 분석한 결과는 다음과 같다. 우선, 콘택트렌즈와 코로나바이러스 진단키트의 주요 위반사항은 부정표시(Misbranding)에 해당한다. 이는 FDA에 관련 통지나 정보가 규정대로 제공되지 않았거나, 시판 중인 기승인 의료기기(Predicate Device)와 비교하여 본질적 동등성을 입증하지 못한 경우가 많다. 반면, 의약품은 유효성 및 안전성 입증 관련 규정에 따라 신청서의 승인을 받지 못한 미승인 신약(Unapproved New Drug)에 해당한다. 결과적으로 바이오헬스 산업의 수입거부는 무역기술장벽(TBT)과 밀접한 관련이 있다.

• 한국포장학회지
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• 제5권2호
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• pp.42-58
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• 1999

Packaging materials and articles that are used in food contact applications can transfer constituents in the foodstuffs. This kind of risk of possible health hazards to consumers has been generally recognized for a long time with the consequence of establishing corresponding food regulations in most developed countries. However, the language of these laws, their interpretation, and their level of enforcement vary from country to country. Accordingly, the actual migrating levels from packaging materials can be varied depending on the migration testing methods as prescribed in the national legislation in each countries. Therefore, there are needs of elimination of non-tariff trade barriers raised by sanitary and phytosanitary or technical measures under the Final Act of the UR Agreement. In this connection, the EU and USA are currently in an ongoing process of legislation harmonization to overcome potential barriers to free trade. In general, regulations governing component transfer in the USA are more complicated and comprehensive than similar regulations in Europe. In future, standard migration testing procedures for microwave heat susceptor materials and for the use of fatty food simulant should be established and also harmonized among countries. The objective of this investigation is to compare the current regulations for migration testing for plastic containers and packaging materials in USA, EU and Korea or Japan. For those regulations, Korean standards are required to be kept up with the international standards. By doing this, the related Korean regulation could be amended along with the worldwide progress for harmonization.

• 한국식생활문화학회지
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• 제28권1호
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• pp.89-98
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• 2013

The purpose of this study was to develop measures for establishing and enforcing legal nutrition labeling for Takju based on results from consumer awareness surveys, statistical model development, and evaluation of nutrients. The statistical model developed with consumer survey results showed that consumers would like to know the nutrients they intake from drinking Takju, as their awareness about Takju was low. Specifically, consumers would like to see information regarding alcohol content, calories, carbohydrates, and saccharides on the label. Structural equations from the research model showed that consumers who had some knowledge of Takju also had positive thoughts of the nutrition fact labels for Takju. Evaluation of nutrients in Takju showed that the starch sources and other ingredients used in Takju fermentation did not influence nutrient facts, and nutrient concentrations also varied among the different Takju. In addition, this research suggests methods for consumers to make reasonable selections and to inform them of the nutrition fact labeling for Takju. Benners and pop-up were manufactured to promote voluntary participation of companies and to provide nutrition facts from Takju. Eventually, a measure was suggested to establish and enforce nutrition labeling, using results from consumer and nutrient surveys of Takju.

• 한국동물위생학회지
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• 제29권3호
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• pp.277-285
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• 2006

Plasmids are covalently closed circular molecules of DNA that are stably inherited and replicate somewhat independently of the bacterial chromosome. Genes carried on plasmids can mediate a wide variety of important functions, including antibiotics (R plasmids) and heavy metals resistance, toxins production, cell penetration, iron chelation, complement resistance, and metabolic characteristics such as sucrose and lactose fermentation. Fifty strains of lactobacilli were isolated from 26 staters and 29 fermented milk products. They were classified 27 strains as Lactobacillus paracasei subsp paracasei, 11 stains as Lactococcus lactis subsp cremoris, 6 strains as L delbrueckii subsp lactis, 4 strains as L acidophius, and 2 strains as L delbrueckii subsp bulgaricus. All of these strains were examined for drug resistance and transferability of R plasmids. All of the isolates were sensitive to Am, C, CF, E, NB, P, T, and Te. But resistant to SXT 94% (47 strains), K 66% (33 strains), S 56% (28 strains), ENR 50% (25 strains), NOR 38% (19 strains) CIP 38% (19 strains), GM 16% (8 strains), and N 14% (7 strains), in order. And 32 different resistant patterns were found. The most frequently encountered patterns were CIP-ENR-K-NOR-S-SXT (5 strains). In vitro R plasmids transfer experiment, 57 antibiotic resistant strains which were not transfer to the recipient 2 Escherichia coli strains by conjugation, These results indicate that Lactobacillus in internal trade market' stater recognize R factor but transmissible R plasmid is not existed.

• 한국식품위생안전성학회지
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• 제32권5호
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• pp.348-354
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• 2017

본 연구에서는 단일 시료를 검사하는 식품공전의 방법을 통계적 개념인 n, c, m, M을 도입하여 국제기준에 발맞춘 시스템을 확립하고자 식품 중 미생물 오염실태 조사 및 기준 규격 재평가를 실시하였다. 즉석섭취 편의식품류에 대한 미생물의 오염도 조사를 위한 모니터링을 실시하였으며, 이를 바탕으로 통계적 개념을 도입하여 새로운 기준 규격을 마련하고자 하였다. 즉석섭취 편의식품류 총 2,040건(즉석섭취식품 630건, 즉석조리식품1,020건, 신선편의식품390건)을 구입하여 일반세균수, 대장균군, E. coli, B. cereus, S. aureus, C. perfringens 에 대한 모니터링을 진행하였다. 즉석섭취 편의식품류의 일반세균수는 평균 2.10 log CFU/g, 대장균군은 평균 -0.60 log CFU/g, E.coli은 평균 -1.33 log CFU/g, B.cereus은 평균 -1.23 log CFU/g으로 검출되었으며, S.aureus은 신선편의식품에서만 평균 -1.35 log CFU/g, C. perfringens은 즉석조리식품에서만 평균 -1.37 log CFU/g 검출되었다. 일반세균수, B. cereus, S. aureus, C. perfringens은 현 기준규격을 초과하지 않은 것으로 나타났으나, 신선편의식품에 한하여 E. coli 는 34건이 식품기준 및 규격을 초과 하였다. 즉석섭취 편의식품류의 모니터링 결과를 바탕으로 Newsamplesplan 2 프로그램을 활용하여 이론적 규격을 도출하였다. 오염 분포도가 넓어 사실상 규격 마련의 실효성이 없는 것으로 파악되었고, 대장균은 즉석섭취식품 및 즉석조리식품에서 n=5 c=1 m=0 M=10으로, 신선편의식품에서는 n=5 c=1 m=10 M=100으로 이론적 규격이 필요할 것으로 판단된다.

• Communications for Statistical Applications and Methods
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• 제17권1호
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• pp.107-115
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• 2010

제제간의 생물학적 동등성을 입증하는데 실패했을 때 추가시험을 허용하는 새로운 생물학적 동등성 시험 기준이 2008년 7월부터 시행하게 되었다. 추가시험의 의미나 시험 기준에서 제시하는 절차를 살펴보고 추가시험의 통계학적 의미를 고찰한다. 또한 사례를 통해 추가시험을 고려할 경우 어떤 점에 유의하여야 성공 할 수 있을 것인가 논의한다.

• Natural Product Sciences
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• 제18권2호
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• pp.76-82
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• 2012

Stamens of Mesua ferrea L. are a well-known herbal drug used in Indian System of Traditional Medicine to treat various diseases. The claimed activity of this plant part is necessitated to investigate antioxidant and hepatoprotective activity. Authenticated plant sample was extracted with hexane, ethanol (EtOH) and water (aq.) using ASE 100 accelerated solvent extractor. Antioxidant activity was evaluated by means of different in vitro assays. Hepatoprotective effect was investigated on carbon tetrachloride induced oxidative stress in liver slice culture model. Cytotoxic marker lactate dehydrogenase (LDH) released in culture medium and the activity of lipid peroxidation along with antioxidant enzymes (AOEs) namely superoxide dismutase (SOD), catalase (CAT) and glutathione reductase (GR) were estimated. Hexane and EtOH extracts were significantly inhibited DPPH, NO, SOD and $ABTS^+$ radical in dose dependent manner. The trade of phenol content was: aq. extract < hexane extract < EtOH extract. A significant correlation was shown by total phenol content and free radical scavenging activity of extracts. The culture system treated with hexane extract, EtOH extract or ascorbic acid exhibited significant depletion in LDH, lipid peroxidation, antioxidative enzymes SOD, CAT and GR. Hexane extract and EtOH extracts of stamen of M. ferrea protected liver slice culture cells by alleviating oxidative stress induced damage to liver cells.

• 동아시아식생활학회지
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• 제17권3호
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• pp.456-462
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• 2007

Food safety has been a growing consumer concern over the last few decades, and remains a priority for consumers, the food industry, and regulatory agencies alike. Although consumer concern for food safety has increased, consumer confidence has decreased. The emphasis on food safety is related to that of preliminary risk management. The ability to collect and provide food risk information is a key element in enhancing the way food safety authorities protect consumers from risk. This review aims to investigate the current situations of international organizations, as well as several countries' systems for collecting and providing food risk information. Through the comparison and analysis of each system, this review proposes strategies to establish a systematic collecting of information and provision of infrastructure in Korea. To develop an information collection system suited to Korea's situation, it is necessary for Korea to strengthen interactions and cooperation with other trade partners through the enlargement of international networks. Such efforts on food risk communication should be made by providing high quality and clear information.

• 대한한의학원전학회지
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• 제12권2호
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• pp.56-71
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• 1999

1. In the recohnition of cosmos true form, It is compared to the Boundless(無極) the Great Absolute(太極),Yin and Yang(兩儀) throungh the fertilazation process of spermatozoon and ovum. 2. It is explained that principle of unchange through the Form and Action(體 用) relation of the outer appearances and Number (象數) with matching the number of nine and ten to HaDoo(河圖) and RakSye(洛書). 3. Eigth divinations(八卦) being compared to the human body, Care presevation of pregnancy(養胎) is explained that head forms firstly(Gun-I 1乾一), secondly lung(Tae-E 兌二), heart(E-Sam 離三), liver(Jin-Sa 震四), gall bladder(Son-Oo 巽五), kidney(Gam-Yuk 坎六), intestines and stomach(Gan-Chill 艮七), lastly flesh forms(Gon-Pal 坤八). 4. It is explained that process of physiological change of $\ll$Nei Ching The Natural Truth in Ancient Times$\gg$(內經 上古天眞論) by matching boy at the age of 8 to Gan-divination(艮卦), and girl at the age of 7 to Tae-divination(兌卦). 5. The theory of six sons from Gun-Gon(乾坤六子論) is explained by relation of Apriority Eight-divination(先天八卦) obedience and disobedience-left and right. 6. It is explained that form of the human-body and the relationship of the Heart - the Kidney through the Gam(坎) Li(離) - divination 7. The effort of interpretating time and space of the Twelve Horary signs is explanined by season, direction, Five elements(五行), rise and decline, the Three Sum(三合), the Six Sum (六合), the six crash(六衡)'s relation. 8. the process of change from apriority(先天) to postery(後天) in the book of Changes(周易) is explanined by comparing to the phenomenum of nature and the human body. 9. The Energy Satus(氣位) are different from the direction of Eight-divination(八卦) and the properties of the good or bad of herb-drugs are differnt from the place of production. 10. The rightness of realizating the Overlapping-divinations(重卦) are compared to the phenomenum of nature through the Divination Virture(卦德). 11. The dependence-relations of The Twelve Meridians(十二經脈) are explained by-matching January with liver meridian, February with gall bladder meridian, march with heart pericardium meridiam, April with small intestine meridkan, August with lung spleen meridian, jury with stomach meridian, August with lung meridian, September with large intestine meridian, October with urinary bladder meridianm November with kidney meridian. December with triple energizer meridian throng The Twelve Byuk-divination. 12. The process of menstration cycle is explained by The Month symbolizing-divination(月候卦). 13. Through The Trade(交易) prove the reason of feverish sympotoms to use feverish Drug, mill sympotoms to use mill drug of prescription and Heart-Kidneys Consensus(心賢相交) and through The Change(變易), prove the chill and feverish consensus of forechill after feverish, fore feverish after chill and through. The Non-Change(不易) explain the reason of chill sympotoms to use feverish drug, feverish sympotoms to use chill drug of prscription. 14. Ho-divination(互卦) applicate Jxa Sa(佐使) herb drug match of Kun Sin Jwa Sa() theory. 15. According to the Hyo-position(爻位) match the ages, body form and drug by matching Ehight-divination(八卦) to the human body form and function in medicine and the book of Changes(周易) application emphasize the human body Ehight-divination(人身八卦). 16. Throgh the Order-divination(序卦) explain the rightness of Divination Image(卦象) arrangement and all things take shape by cosmo-energy conseusus(宇宙氣交). 17. Throgh the Mixing-divination(難卦) supply the vacancy of medicine and the book of Changes(周易) relationship in the foreword explian the human energy movements, sleep, vomitting, the energy arrival(逮氣), heart pericardium(心包), lung membrane(肺膜) etc.... Like the above sentence medicine and the book of Changes(周易) theory of scholar Tang on the viewpoint of easten-the way Western appliance(東道西器) researching abyss of medicine impart to descendants, so I think that the achievement of medicine and the book of Changes(周易) study is very excellant and I expect that the study Korean Oriental Medicine(韓醫學) theory by means of medicine the book of Changes(周易) reference, will be accelarated.

• 한국식품위생안전성학회지
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• 제32권5호
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• pp.381-388
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• 2017

본 연구에서는 향신료 중 천연유래 보존료의 함유량을 조사하기 위하여 안식향산, 소브산 및 프로피온산의 함유량을 분석하였다. 향신료 중 안식향산 및 소브산 함량은 액체크로마토그래프 질량분석기(LC-MS/MS)를 이용하였고, 프로피온산 함량은 가스크로마토그래프 질량분석기(GC-MS)를 이용하였다. 에탄올을 이용하여 용매추출 후원심분리 후 농축하는 방법으로 전처리 방법을 확립하였고, 직선성, 검출한계, 정량한계, 회수율 측정으로 분석방법을 검증하였다. 향신료 493건 수거하여 분석한 결과, 안식향산, 소브산, 프로피온산은 각각 165건, 88건, 398건에서 검출되었다. 안식향산, 소브산, 프로피온산의 검출 범위는 각각 불검출-391.99 mg/L, 불검출-57.70 mg/L, 불검출-188.21 mg/L이었다. 안식향산, 소브산, 프로피온산의 평균 검출량이 가장 높게 나타난 품목은 각각 계피(167.15 mg/L), 바질잎(22.79 mg/L), 백후추(51.48 mg/L)이었다. 본 연구에서 확립된 분석방법은 다양한 향신료를 대상으로 낮은 함량의 천연유래 보존료(안식향산, 소브산, 프로피온산) 분석에 적합한 방법이며, 분석결과는 향신료의 천연유래 보존료 함유량을 알 수 있는 근거자료이다. 따라서, 본 연구의 결과는 향후 식품 검사 시 보존료 사용기준 위반 판정으로 인한 민원제기나 국가간 무역마찰 시 기초자료로 활용될 수 있을 것이다.