• Journal of Pharmaceutical Investigation
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• v.30 no.4
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• pp.299-307
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• 2000

생물학적 동등성 시험은 동일 성분을 동량 함유한 제제가 유사조건에서 투여되었을 경우 그 유효성분이 전신순환혈이나 작용부위에서 유용하게 되는 속도 및 양에 큰 차이가 없음을 입증하는 시험이다. 즉 이미 제조허가 되어 시판중인 의약품과 동일한 품목의 제조허가를 받기 위한 경우이거나 생체이용률이 동일함을 증명하기 위해 실시하는 시험이다. 우리 나라에서는 1989년 1월 1일 이후 허가된 전문의약품으로서 신약과 동일한 의약품, 패취제제, 제제개선을 통해 흡수율을 높이는 경우에 생물학적 동등성 시험을 하도록 의무화하고 있다. 미국 FDA는 1975년 6월 생체이용률, 생물학적 동등성에 관한 규제안을 발표하였고, 우리 나라에서도 1988년 10월에 생물학적 동등성 시험 기준을 제정하였다. 유럽에서는 1991년 12월 CPMP(Committee for Proprietary Medicinal Products)에 의해 최초로 "생체이용률 및 생물학적 동등성에 대한 가이드라인"이 채택되었다. 그후 전문가 회의를 거쳐 규정 전반에 관한 것과 일반적 항목에 대한 검토가 이루어져 최종 개정된 가이드라인이 만들어졌다. 현재 in vivo 생체 이용률을 비교하는 생물학적 동등성 시험의 중요성이 증대되고 있고, 국제적으로도 각 국가별 생물학적 동등성 시험의 평가방법이나 기준설정에 대한 연구가 다양하게 이루어지고 있다. 또한 ICH에서도 생물학적 동등성 시험의 국제적 조화를 위한 시도가 이루어지고 있다. 우리 나라의 현행 생물학적 동등성 기준은 1998년 개정된 것을 사용하고 있으나 국제적 발전 추세에 맞추어 기준의 제고를 모색하고 있다. 그 일환으로 유럽의 "의약품의 생체이용률 및 생물학적 동등성 시험 가이드라인"을 소개하고자 한다., globunlin II의 두 component로 분리(分離)되었고 oryzenin은 시료(試料) 육우(陸羽) 132호(號), 등판(藤坂) 5호(號), 관산(關山) 재건(再建)에서는 oryzenin I, oryzenin II, oryzenin III의 3 component를 분리(分離)하였고 팔달(八達), 진흥(振興), 서광(瑞光), 은방주(銀坊主), 다마금(多摩錦), Pin Galw56의 6시료(試料)에서는 oryzenin II, oryzenin III의 2 component만 분리(分離)하였다. 3. 각(各) fraction을 여지전기영동(濾紙電氣泳動)하여 각(各) component의 농도곡선(濃度曲線)에 의해 함량(含量)을 구(求)한 결과(結果) albumin 0.26%, globulin I, 0.35%, globulin II, 0.32%, prolamin, 0.41%, oryzenin I, 0.30%, oryzenin II, 2.23%, oryzenin III, 2.66%이었다.미국의 경우 3일 이내 전화나 FAX로 보고하고, 10일이내 문서로써 보고하도록 되어 있다. 이러한 임상적 안전성 자료 관리에 대한 신속 보고 정의 및 기준에 대해서는 ICH에서도 논의가 되어 Step 4까지 다다르고 있으므로 앞으로 각 국에서의 적용만 남아있는 상태이고 보면 신약의 개발과 더불어 임상시험에서의 부작용등의 안전성 자료 관리에 대한 중요성은 더욱 강조될 것이다.공하는 음식의 섭취정도에도 영향을 주고 있으므로 학생들에게 학부모와 전담교사 및 학교영양사는 학생들에게 이상적인 아침식사에 대한 교육은 물론이고 아침식사를 실천할 수 있도록 다양한 방안에 대해 함께 연구해야 하겠다. 정부차원에서 학교급식에 아침식사 프로그램을 도입할

• Journal of Nutrition and Health
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• v.46 no.5
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• pp.447-460
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• 2013

Dietary supplement use is prevalent and represents an important source of nutrition. This study was conducted in order to assess the dietary maximum exposure of vitamins and minerals from various sources including regular diet, vitamin mineral supplements for non-prescription drug (VMS-NPD), vitamin mineral supplements for health functional foods (VMS-HFF), and fortified foods (FF). A total of 1,407 adolescent boys and girls attending middle or high schools were chosen from various cities and rural communities in Korea. Users of vitamin and mineral supplements (n = 60, 15-18 years of age) were chosen from the above 1,407 students. Intake of vitamins and minerals from a regular diet and FF was assessed by both food record method and direct interview for three days of two weekdays and one weekend, and those from VMS-NPD and VMS-HFF were assessed by both questionnaire and direct interview, and compared with the recommended nutrient intake (RNI) and the tolerable upper intake level (UL) for Korean adolescents. Daily average exposure range of vitamins and minerals from a regular diet was 0.3 to 4.4 times of the RNI. Some subjects had an excessive exposure to the UL in the following areas: from regular diets, vitamin A (1.7%) and niacin (5.0%); from only VMS-NPD, vitamin C (9.1%) and iron (5.6%); and from only VMS-HFF, niacin (8.6%) > vitamin $B_6$ (7.5%) > folic acid (2.9%) > vitamin C (2.3%). Nutrients of daily total intake from regular diet, VMS-NPD, VMS-HFF, and FF higher than the UL included nicotinic acid for 33.3% of subjects, and, then, in order, vitamin C (26.6%) > vitamin A (13.3%), iron (13.3%) > zinc (11.7%) > calcium (5.0%) > vitamin E (1.7%), vitamin $B_6$ (1.7%). Thus, findings of this study showed that subjects may potentially be at risk due to overuse of supplements, even though most of them took enough vitamins and minerals from their regular diet. Therefore, we should encourage adolescents to have sound health care habits through systematic and educational aspects.

• Journal of Oral Medicine and Pain
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• v.38 no.2
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• pp.109-114
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• 2013

Chemical burn on the oral mucosa is caused by contact with various chemical products and manifests with localized mucositis, keratotic white lesions, bleeding, and painful tissue surface due to the coagulation of the tissue. Policresulen ($Albothyl^{(R)}$) is a topical antiseptic, commonly used over-the-counter drug for vaginitis, thrush and stomatitis. This drug is highly acidic with pH 0.6, and can act as a strong corrosive agent to oral mucosa. When inadvertently used in oral cavity, it may cause chemical burns of oral mucosa, resulting necrosis and bleeding surface resembling to erythema multifome. A 56 years old female patient presented with the chief complaints of painful ulcerations on the tongue, the upper and lower lips. On intraoral examination, an erythromatous, erosive or ulcerative surface covered with inflammatory exudates or bleeding crust is observed on the anterior half of the tongue and the upper and lower lips. She has occasionally applied the policresulen solution topically on the tongue to relieve pain from recurrent focal glossitis for about 10 years. In this time she applied it broadly and repeatedly to the tongue, the upper and lower lips for the purpose of pain relief by herself without instruction by physician or dentist. After cessation of policresulen application, the oral mucosa was rapidly recovered with use of topical steroids. In 2 weeks the lesions subsided completely. In summary, inadvertent use of $Albothyl^{(R)}$ on oral mucosa may result in chemical burn, causing mucosal erosion, ulceration and inflammation. It can be recovered by topical use of corticosteroid for 2 weeks after cessation of using $Albothyl^{(R)}$.

• The Journal of the Convergence on Culture Technology
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• v.8 no.3
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• pp.405-413
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• 2022

Since the COVID-19 outbreak, the active utilization of new health care service utilizing the ICT technology and data science such as telemedicine, smart hospital, AI dignosis has been increasingly found. In this study we examined the business model of Amazon healthcare which leads disruptive innovation in U.S. health care industry with the introduction of hybrid model of telemedicin, in-person care and customer-centric online drug delivery, home-use diagnostic kit, characterized by the integrated model combining medical care, drug delivery and the use of diagnostic kit. We showed using the multiproduct competition model that the synergy effect between the Amazon's original business areas and the healthcare business area causes the active market penetration and the increase in the customer value from utilization of the Amazon care. Using Hotelling's spatial competition model, we also showed that the competition in the health care market can be greater when consumer's choice of health care providers are available in telemedicine platform. In the long, run the issue of competition being weakened due to the exit of less competent healthcare providers may arise, to which the policymakers in the charge of fair competition in health care industry should pay attention.

• Korean Journal of Clinical Laboratory Science
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• v.56 no.2
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• pp.171-180
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• 2024

The endotoxin test is based on the reaction between Limulus Amebocyte Lysate (LAL) and the lipopolysaccharides of Gram-negative bacteria. In this study, we sought to identify factors that interfere with the LAL testing of radiopharmaceuticals and evaluated acceptable ranges. A gel-clot LAL test and a chromogenic LAL test were used as endotoxin tests. We compared the performances of the Endosafe^Ⓡ LAL and recombinant Endosafe^Ⓡ Recombinant Cascade Reagent (rCR) cartridges for the chromogenic test. The factors that interfered with ⁶⁸Ga-DOTATOC injection were pH, 4-(2-hydroxyethyl) piperazine-1-ethanesulfonic acid (HEPES) buffer, and organic solvents, especially ethanol. However, interference by these factors was overcome by diluting the ⁶⁸Ga-DOTATOC injection tenfold. In addition, no interference was observed at pH values between 4 and 8, at a HEPES concentration of 2,000 ㎍/mL, or an ethanol concentration of <1%. Furthermore, results showed that interfering factors had similar effects on the performances of the Endosafe^Ⓡ LAL and Endosafe^Ⓡ rCR cartridges. The results of this study are expected to be useful for evaluating factors that interfere with the endotoxin testing of new radiopharmaceuticals.

• Culinary science and hospitality research
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• v.21 no.5
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• pp.160-170
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• 2015

In accordance to the increasing number of death due to cancer and side effects of chemotherapy, attention has recently focused on combined treatment of natural component and anti-tumor agent. Therefore development of safe and effective functional substances derived from natural materials is required. The emergence of various functional activities of Rubus coreanus Miquel, such as antioxidant, anticancer, anti-inflammatory, etc. is continuously increasing its consumption. To utilize the above activities, many products developed by using Rubus coreanus Miquel extracts in the areas of foods, liquors, and cosmetics and medicines. In this review, anti-cancer, anti-inflammatory activity and patents of Rubus coreanus Miquel are summarized. Further studies are needed to search for development of functional material from natural origin and various application possibility using stem, leaf and fruit of Rubus coreanus Miquel.

• Health Policy and Management
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• v.24 no.2
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• pp.164-171
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• 2014

Background: Safety of drugs has become a major issue in public healthcare. Spontaneous reporting of adverse drug reaction (ADR) is the cornerstone in management of drug safety. We aimed to investigate the awareness and knowledge of spontaneous ADR reporting in general public of Korea. Methods: A total of 1,500 study subjects aged 19-69 years were interviewed with a questionnaire for their awareness and knowledge related to spontaneous ADR reporting. Computer assisted telephone interview was performed from 27th February 2013 to 4th March 2013. Target population was selected with quota sampling, using age, sex, and residence area. Healthcare professionals such as physicians, pharmacists, and nurses were excluded. The survey questions included awareness of spontaneous ADR reporting, opinions on ways to activate ADR reporting, and sociodemographic characteristics. Results: Overall awareness of spontaneous ADR reporting system was 8.3% (${\pm}2.53%$) among general population of Korea. Major source from which people got the information regarding ADR reporting was television/radio (69.9%), followed by internet (19.3%), and poster/brochure (6.1%). Awareness level differed between age groups (p<0.0001) and education levels (p<0.0001). Upon learning about the ADR reporting system, 88.5% of study subjects agreed on the necessity of ADR reporting system, while 46.6% thought promotion through internet and mass media as an effective way to activate ADR reporting. Conclusion: The overall awareness of spontaneous ADR reporting should be enhanced in order to establish a firm national system for drug safety. Adequate promotions should be performed targeting lower awareness groups, as well as various publicity activities via effective channels for the general population.

• Korean Journal of Clinical Pharmacy
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• v.21 no.3
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• pp.237-242
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• 2011

This study measures seriousness of adverse drug reactions (ADRs) among Korean physicians and pharmacists using two times surveys based on Delphi technique. Each participant scored 20 ADR terms on a scale of one to ten (10 being the most serious). We repeated the exercise for the 49 first survey respondents and 32 re-evaluated score. We compared the results of our survey with those of WHO CIOMS (Council for International Organization of Medical Sciences) working groups members conducted in 1995. The overall mean ADR seriousness score was 6.49 for Koreans and 5.12 for WHO CIOMS members, presenting Korean experts perceived more seriously for each ADR. Mean score changes for the same respondents showed similar trends regardless of access to the first survey results. There were no statistically significant score differences between the physicians and the pharmacists. The high consensus of seriousness for each ADR between the Korean experts and the WHO CIOMS members implies that the similar results are reproducible, suggesting the possibility of developing standardized tools for measuring the seriousness of individual ADRs in the future.

• The Optical Journal
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• s.158
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• pp.48-51
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• 2015

2013년 12월 2일에 아마존의 제프 베조스가 드론을 통하여 30분 배송을 실현하겠다고 배송 테스트를 했다. 고객이 주문한 물건을 플라스틱 보호 박스에 잘 담아 드론에 싣고 고객의 마당에 떨구고 돌아오는 모습을 담았다. 미국의 모든 언론은 드론에 대하여 대서특필하였고, 30분 배송의 실현 가능성에 대한 논쟁을 벌였다. 그 해 연말, 아마존은 쇼핑특수를 누렸다. 돈 안들이고 광고를 독특하게 한 셈이다. 나는 개인적으로 아마존의 드론 배달을 '쇼'라고 생각했다. 고객들의 주거 형태, 드론 비행의 법적인 문제, 드론으로 발생되는 사고, 사람들의 인식 등등 문제가 산적해 있기 때문이다. 그런데 2015년 초부터 알리바바는 1시간 내 차(Tea) 배달 서비스를 상하이와 광저우에서 테스트 중이라고 한다. 또한, DHL이 바다를 건너 섬으로 의약품을 수송하는 시연을 했다. CES 2015에서는 드론 전용관을 만들어 많은 사람들과 언론의 주목을 받았다. 마치 꿈과 같던 것이 실현되는 느낌이었다. 드론을 띄울 수 있는 권리 외에도 드론을 떨어뜨릴 권리도 논의되고 있다. 일본 총리관저에 드론이 떨어지기도 했다. 미국에서는 소형 드론에 폭발물을 탑재하여 타격하는 영상을 보이기도 했다. 개인적인 프라이버시가 존중되어야 할 가정집 위로 카메라가 달린 드론이 날아다니기도 하며, 재소자들의 수감시설에 마약과 담배를 실어 나르다 적발되기도 하였다. 부작용도 만만치 않다는 이야기이다. 나는 학생들에게 100만 원이 넘는 드론을 구매하여 주었더니, 동력인 배터리가 20분밖에 안 된다고 투덜거린다. 영상에 그리고 비행에 소리가 너무 난다고 또 투덜거린다. 바람에 밀려 조정이 어렵다고 또한 투덜투덜하더니만, 결국은 비행 중 조절이 안 되고 떨어져서 결국 박살이 났다. 내구성이 약하다는 이야기는 곧 전반적으로 아직 한계가 있으며 개선할 점이 많다는 의미이다. 위와 같은 부정적인 요인에도 불구하고 드론은 새로운 서비스의 융합으로 신시장이 기대되는 만큼 많은 국가와 기업들이 주목하고 있다. 미국가전협회(CEA)는 2015년 세계 드론 시장이 2014년보다 무려 55% 성장한 1억 3,000만 달러의 규모로 성장하고 5년 뒤에는 10억 달러까지 증가할 것으로 전망하면서 드론 산업의 가능성을 높게 평가하기도 했다.

• Analytical Science and Technology
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• v.23 no.6
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• pp.579-586
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• 2010

Commercially widely used antitumor agents such as hydroxy urea, 6-mercaptopurine monohydrate, cytosine arabinoside, cyclophosphamide monohydrate and uracil were reacted with 3-(triethoxysilyl)propyl isocyanate and the product hydrolyzed to give silica nanoparticles bound antitumor agents ranging from 10 nm to micron-sized aggregates. The silyl isocyanate derivative was also reacted neat with water to give hybrid organicsilicananoparticles containing $-CH_2-CH_2-CH_2-NH-COOH$ or the corresponding decarboxylated propylamine groups depending on solvent and temperature employed. In vitro tests these functionalized silica nanoparticles were effective in the treatment of malignant tumor cells but had little or no effect on normal cells. Malignant human lung, ovarian, melanoma, CNS(Central nervous system) and colon tumor cells were used in this research. The use of silica as a carrier medium in the present research serves as a model material due to its ready functionalization via silation. The proof of concept established by the results suggests that the technique may be applied to other, more biocompatible carrier nanoparticles.