• Translational and Clinical Pharmacology
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• 제26권4호
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• pp.155-159
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• 2018

For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

• 한국식품과학회지
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• 제48권5호
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• pp.399-404
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• 2016

국내 조사처리 허용품목을 대상으로 다소비, 다빈도, 다수입 품목 12종(감자, 양파, 마늘, 건호박, 목이버섯, 검은콩, 청국장가루, 미역, 고춧가루, 라면수프, 옥수수차, 분말 녹차)을 선정하여 조사처리 선원에 따른 물리적 확인시험법(PSL 및 TL)을 적용하여 조사처리 여부를 확인하였다. PSL 적용 결과 모든 비조사 시료에서는 700 count/60초($T_1$) 이하의 값을 나타내어 음성 또는 비조사판정이 가능하였다. 감마선, 전자선과 X선을 처리한 시료에서는 879-2,414 (intermediate)와 19,951-65,919,035 (positive) 범위로 수치가 확인되었으며 조사 선원에 따른 수치차이는 보이지 않았다. TL 적용 결과 비조사 시료에서는 $300^{\circ}C$ 이상에서 자연방사선에 의한 peak를 나타내는 비특이적인 글로우 곡선을 보였으며 3개의 선종별 TL 분석 결과에서는 $150-250^{\circ}C$의 온도 범위에서 최대 peak를 나타내었다. 한편, 선종별 TL 강도 차이는 청국장 분말의 경우 감마선(${\gamma}$)>전자선(E)>X선(X), 고춧가루와 분말 녹차는 ${\gamma}$>X>E, 미역, 목이버섯, 마늘은 E>${\gamma}$>X, 양파, 감자, 검은콩는 E>X>${\gamma}$, 라면수프와 옥수수차는 X>E>${\gamma}$, 건호박은 X>${\gamma}$>E의 순서로 TL 강도 차이를 나타내었다. 이와 함께, TL ratio($TL_1/TL_2$) 값은 조사처리구에서 0.1143-2.9318 범위를 나타내어 국내 단일시료 조사판정 범위인 TL ratio 0.1 이상을 확인할 수 있었다. 따라서 조사처리선원에 따른 조사여부 판정은 현행 물리적 확인시험법으로 가능하였으며 광물질의 함량과 조사처리 선량 등 식품 중 조사처리에 관한 연구가 지속적으로 수행되어야 할 것으로 생각된다.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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• pp.125.2-126
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• 2003

Human tumor necrosis factor-alpha (TNFa) is a key pro-inflammatory cytokine produced by activated monocytes and macrophage as a part of the self-defence machinery. TNF-a converting enzyme (TACE) is the metalloproteinase that processes the membrane bound precursor of TNFa to the soluble component. (omitted)

• 대한약학회:학술대회논문집
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• 대한약학회 2001년도 Proceedings of International Convention of the Pharmaceutical Society of Korea
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• pp.203.1-203.1
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• 2001

• 대한약학회:학술대회논문집
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• 대한약학회 2004년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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• pp.111-111
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• 2004

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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• pp.42-42
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• 2003

Recently, Korean Food and Drug Administration (KFDA) has been attempting to modernize the review processes for generic drug products. Obviously, the modernization effort will lead to harmonize the guidelines in the process to the internationally acceptable level. In general, the Korean version of abbreviated new drug application (ANDA) consisted of similarly to those in developed countries (viz, specifications for bulk drug/preparation, bioequivalence, and stability); However, there exists a significant gap in the sophistication of the guidelines between the Korean version and those in the other countries. (omitted)

• 한국독성학회:학술대회논문집
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• 한국독성학회 2001년도 International Symposium on Signal transduction in Toxicology
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• pp.110-110
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• 2001

To compare skin irritation and cytotoxicity of anti-wrinkle agents, we examined skin irritation of six anti-wrinkle agents (ascorbic acid, glycolic acid, all trans-retinoic acid, ginseng extract, retinol, EB) in New Zeland white rabbit.(omitted)

• 미생물학회지
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• 제54권2호
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• pp.140-145
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• 2018

미세조류의 세포벽을 파쇄하여 지질을 추출하는 과정은 에너지를 많이 소비하는 과정으로 알려져 있다. 본 연구에서는 바이러스 감염을 통한 미세조류의 세포벽 파쇄 및 지질 추출법의 효율을 현재 사용되고 있는 마이크로파와 초음파를 이용한 추출법의 효율과 비교하였다. 바이러스 감염을 이용한 지질 생산율은 초음파 및 마이크로파의 생산율과 유의미한 차이를 보이지 않았다. 이는 같은 양의 지질을 낮은 에너지와 비용으로 얻을 수 있을 뿐만 아니라, 클로렐라 바이러스 감염에 의한 미세조류 지질 추출법을 대량 생산 시설에 적용 시 바이오 디젤 생산 비용을 절감할 수 있음을 시사한다.

• Toxicological Research
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• 제17권
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• pp.211-216
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• 2001

Drugs can have various adverse effects on the immune system including unintended immun-osuppression, induction of both drug-specific immune responses (including drug allergies) and non-specific immunostimulation (including autoimmune reactions), and direct activation of effector mechanisms (such as histamine release). As a practical matter, the Center for Drug Evaluation (CDER) relies on standard non-clinical toxicology studies to detect unintended immunosuppression. Specific assays using guinea pigs and mice are available to identify drugs that can induce immune-mediated dermal hypersensitivity reactions. Respiratory and systemic hypersensitivity and autoimmune reactions are more difficult to model in non-clinical studies. Unintended nonspecific immunstimulation can be detected in animal studies. CDER is currently developing specific guidance for evaluating potential drug immunotoxicity.

• 대한화장품학회지
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• 제21권2호
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• pp.73-93
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• 1995

The effect of natural products(drug 1, drug 2) on hair growth of frontal scalp of ten stumptailed macaques was investigated in period of 12 months. Drug 1 conteins extracts of Angelica gigantis Radix ok. and drug 2 conteins extracts of Corm Fructus, etc. Photographs of close view of the frontal scalp were taken once every month and folliclogram analysis has been done at pretretment and on 5th, 10th and 12th month after treatment. Drug 1 showed only slight effect or no effect on hair growth and drug 2 exhibited a significant degree of hair regrowth, but the control group exhibited a definite degree of regrowth and increasing density of vellum hair. Also, the physiological parameters, such as body weight, blood pressure, heart rate, serum levels of androgens, hematological measures during the treatment of drug 1, drug 2, and vehicle, were within normal limits. It indicates the drug 2 is the possible appearance of new summit of hair growth.