• 한국식품위생안전성학회지
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• 제24권3호
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• pp.238-246
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• 2009

많은 산업체와 실험실에서 사용되고 있는 공업용 화학물질인 아크릴아마이드는 발암유발가능성이 있는 것으로 알려져 있으며, 국내 외 모니터링 결과 감자, 밀 등 고탄수화물 식품을 고온에서 조리,가공한 식품에서 많이 검출되는 것으로 알려져 있다. 아크릴아마이드의 위해평가를 위해서는 식품 내 아크릴아마이드 함량 및 식이노출평가 등의 기초자료가 절실히 요구되나 우리나라는 제 외국에 비해 식품 내 아크릴아마이드 관한 데이터베이스가 미약한 편이다. 이에 본 연구는 국내 유통식품의 모니터링을 통해 아크릴아마이드의 국내 실태를 파악하기 위해 수행 되었다. 모니터 링을 위해 우리나라에서 많이 섭취한 식품을 중심으로 국내 food market shares 등의 통계를 이용하여 17개 식품군에서 470여 개의 시료를 선정하였으며, 이를 FDA의 LC-MS/MS 방법으로 분석하였다. 모니터링 결과, '감자스낵류', '비스킷류', '시리얼류', '초콜릿류', '커피류','prune juice' 등에서 비교적 많은 양의 아크릴 아마이드가 검출되었으며, 각 식품군의 검출수준은 감자스낵류 $195{\sim}4,002ppb$, 비스킷류 $ND{\sim}681ppb$, 시리얼류 $79{\sim}233ppb$, 초콜릿류 $ND{\sim}447ppb$, 커피류 $ND{\sim}681ppb$, prune juice 366ppb로 이는 이전 국내외 분석결과와 비슷한 수치이다. 그러나 지금까지 아크릴아마이드 문제와 관련해서 안전하다고 인식되어 온 과일, 채소류, 해조류, 한과류에서도 아크릴아마이드가 검출됨으로 인해 이들 식품군도 조리방법에 따라서 식이를 통한 아크릴아마이드 노출원이 될 수 있음이 확인되었다. 그 외의 껌, 잼류, 두부류 또는 묵류, 포도씨유, 주류, 건포류에서는 아크릴아마이드가 검출되지 않았다. 본 연구의 결과는 우리나라의 실정에 맞는 아크릴아마이드의 위해 평가를 위한 기초자료로서 사용 될 수 있을 것으로 사료된다.

• KSII Transactions on Internet and Information Systems (TIIS)
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• 제5권10호
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• pp.1830-1840
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• 2011

CDISC (Clinical Data Interchanging Standards Consortium) standards are to support the acquisition, exchange, submission and archival of clinical trial and research data. SDTM (Study Data Tabulation Model) for Case Report Forms (CRFs) was recommended for U.S. Food and Drug Administration (FDA) regulatory submissions since 2004. Although the SDTM Implementation Guide gives a standardized and predefined collection of submission metadata 'domains' containing extensive variable collections, transforming CRFs to SDTM files for FDA submission is still a very hard and time-consuming task. For addressing this issue, we developed metadata based SDTM mapping rules. Using these mapping rules, we also developed a semi-automatic tool, named CDISC Transformer, for transforming clinical trial data to CDISC standard compliant data. The performance of CDISC Transformer with or without MDR support was evaluated using CDISC blank CRF as the 'gold standard'. Both MDR and user inquiry-supported transformation substantially improved the accuracy of our transformation rules. CDISC Transformer will greatly reduce the workloads and enhance standardized data entry and integration for clinical trial and research in various healthcare domains.

• 한국환경과학회지
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• 제17권8호
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• pp.841-856
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• 2008

This research outlines a new method for evaluation of shellfish production in Gamak Bay based on the concept of EMERGY. Better understanding of those environmental factors influencing oyster production and the management of oyster stocks requires the ability to assess the real value of environmental sources such as solar energy, river, tide, wave, wind, and other physical mechanisms. In this research, EMERGY flows from environment sources were 76% for shellfish aquaculture in Gamak Bay. EMERGY yield ratio, Environmental Loading Ratio, and Sustainability Index were 4.26, 0.31 and 13.89, respectively. Using the Emergy evaluation data, the predicted maximum shellfish aquaculture production in Gamak Bay and the FDA (Food and Drug Administration, U.S.) designated area in Gamak Bay were 10,845 ton/y and 7,548 ton/yr, respectively. Since the predicted shellfish production was approximately 1.3 times more than produced shellfish production in 2005, the carrying capacity of Gamak Bay is estimated to be 1.3 times more than the present oyster production.

• 한국산학기술학회논문지
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• 제21권10호
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• pp.471-479
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• 2020

본 연구에서는 급진적 혁신을 수행하는 기업의 특징을 특허 데이터를 중심으로 살펴보았다. 1980년도부터 특허 정보는 기업의 성과를 측정하기 위한 중요한 지표로 활용되어 왔지만, 급진적 혁신을 대표하기는 어려웠다. 따라서 본 연구를 통하여 특허 집약 산업(Patent Active Industry)인 제약 산업에서 특허 정보가 급진적 혁신 지표로서 활용 될 수 있는지 알아보고자 하였다. 분석을 위해 약 10년간의 FDA 승인 데이터, 국외 기업의 특허 데이터를 활용하였으며 네트워크 중심성 분석(Centrality Analysis)과 비모수적 분석법인 윌콕슨 부호 순위 검정(Wilcoxon Signed Rank Test)을 실시하였다. 네트워크 분석 결과 급진적 혁신을 수행하는 기업의 경우 다른 기업들보다 대학 및 타 제약 기업과 협력 활동이 활발함을 시각적으로 확인 할 수 있었으며, 통계분석 결과 급진적 혁신을 수행하는 기업과 그렇지 않은 기업 간 연결 중심성(Degree Centrality)과 근접 중심성(Closeness Centrality)에 차이가 있음을 확인 할 수 있었다. 본 연구의 결과는 기업의 연구개발 전략 및 정책 수립에 활용 될 것을 기대하며, 향후에는 기업의 급진적 혁신에 영향을 미치는 요소가 무엇인지 정량 분석이 가능할 것이다.

• Communications for Statistical Applications and Methods
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• 제24권6호
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• pp.561-581
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• 2017

Bayesian statistics can play a key role in the design and analysis of clinical trials and this has been demonstrated for medical device trials. By 1995 Bayesian statistics had been well developed and the revolution in computing powers and Markov chain Monte Carlo development made calculation of posterior distributions within computational reach. The Food and Drug Administration (FDA) initiative of Bayesian statistics in medical device clinical trials, which began almost 20 years ago, is reviewed in detail along with some of the key decisions that were made along the way. Both Bayesian hierarchical modeling using data from previous studies and Bayesian adaptive designs, usually with a non-informative prior, are discussed. The leveraging of prior study data has been accomplished through Bayesian hierarchical modeling. An enormous advantage of Bayesian adaptive designs is achieved when it is accompanied by modeling of the primary endpoint to produce the predictive posterior distribution. Simulations are crucial to providing the operating characteristics of the Bayesian design, especially for a complex adaptive design. The 2010 FDA Bayesian guidance for medical device trials addressed both approaches as well as exchangeability, Type I error, and sample size. Treatment response adaptive randomization using the famous extracorporeal membrane oxygenation example is discussed. An interesting real example of a Bayesian analysis using a failed trial with an interesting subgroup as prior information is presented. The implications of the likelihood principle are considered. A recent exciting area using Bayesian hierarchical modeling has been the pediatric extrapolation using adult data in clinical trials. Historical control information from previous trials is an underused area that lends itself easily to Bayesian methods. The future including recent trends, decision theoretic trials, Bayesian benefit-risk, virtual patients, and the appalling lack of penetration of Bayesian clinical trials in the medical literature are discussed.

• 대한피부과학회지
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• 제56권10호
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• pp.581-593
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• 2018

Atopic dermatitis (AD) is a common, chronic, relapsing, inflammatory skin disease that affects both children and adults. AD is the cause of considerable morbidity including severe pruritus and impaired quality of life. Treatments for active disease include avoidance of triggering factors, barrier repair, topical medications including topical corticosteroids (TCs) and topical calcineurin inhibitors (TCIs), phototherapy, antibacterial agents, and systemic immunosuppressants including cyclosporine. Until recently, the only Food and Drug Administration (FDA)-approved systemic treatment options for patients with moderate-to-severe AD were steroids and cyclosporine. Systemic steroids are not recommended by current guidelines and are commonly associated with disease rebound. Instead, clinicians choose from several off-label immunosuppressants. In 2018, the Korean FDA approved dupilumab for adults with moderate-to-severe AD whose disease is not adequately controlled with topical therapies. The implementation of treatment guidelines for AD is challenging. Herein, we review the several treatment modalities for AD and recommend a treatment algorithm.

• Journal of Microbiology and Biotechnology
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• 제16권5호
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• pp.651-660
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• 2006

Natural products are a rich source of biologically active small molecules and a fertile area for lead discovery of new drugs [10, 52]. For instance, 5% of the 1,031 new chemical entities approved as drugs by the US Food and Drug Administration (FDA) were natural products between 1981 and 2002, and another 23% were natural product-derived molecules [53]. These molecules have evolved through millions of years of natural selection to interact with biomolecules in the cells or organisms and offer unrivaled chemical and structural diversity [14, 37]. Nonetheless, a large percentage of nature remains unexplored, in particular, in the marine and microbial environments. Therefore, natural products are still major valuable sources of innovative therapeutic agents for human diseases. However, even when a natural product is found to exhibit biological activity, the cellular target and mode of action of the compound are mostly mysterious. This is also true of many natural products that are currently under clinical trials or have already been approved as clinical drugs [11]. The lack of information on a definitive cellular target for a biologically active natural product prevents the rational design and development of more potent therapeutics. Therefore, there is a great need for new techniques to expedite the rapid identification and validation of cellular targets for biologically active natural products. Chemical genomics is a new integrated research engine toward functional studies of genome and drug discovery [40, 69]. The identification and validation of cellular receptors of biologically active small molecules is one of the key goals of the discipline. This eventually facilitates subsequent rational drug design, and provides valuable information on the receptors in cellular processes. Indeed, several biologically crucial proteins have already been identified as targets for natural products using chemical genomics approach (Table 1). Herein, the representative case studies of chemical genomics using natural products derived from microbes, marine sources, and plants will be introduced.

• 한국임상약학회지
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• 제26권2호
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• pp.172-180
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• 2016

Background: Ischemic heart disease is the most common type of heart disease and an important cause of death in Korea. Among marketed anti-anginal medications, molsidomine, nicorandil, and trimetazidine are approved in Korea with unique mechanism of actions. As these drugs are not approved by the US Food and Drug Administration, the access to the up-to-dated and comprehensive safety-related information has been less than optimal from drug information resources used by Korean pharmacists. Methods: A systematic review was conducted using Embase and Korean manuscripts to compile safety updates for these medications. Out of 418 articles from keyword searches, 52 studies were reviewed in full to compare adverse effects (AEs) with the approved package inserts (PI). Results: Molsidomine related adverse effects were mostly mild or moderate, but anxiety, palpitation, epigastric pain, and sexual potency reduction were additional AEs found from the review not listed in PI. Although PI has included ulceration in oral cavity and gastrointestinal tracts including anus by nicorandil, the Korea FDA recently recommended adding corneal, genital, and skin ulcers to the approved PI. Trimetazidine induced Parkinsonism, worsening of the symptoms for patients diagnosed with Parkinson's disease, gastrointestinal burning, and muscle cramps were additionally identified AEs not listed in PI for trimetazidine. Conclusion: Continuous evaluations of the safety profile of these agents are needed to balance the risks and benefits to provide evidence-based safety counseling to the patients. In addition, more focused efforts on spontaneous reporting are warranted by healthcare professionals to safeguard patients against AEs.

• 구강회복응용과학지
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• 제38권1호
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• pp.34-41
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• 2022

최근 디지털 기술과 Computer-aided design/Computer-aided manufacturing (CAD/CAM) 작업 환경은 의치 제작에 있어 임상의의 진료 과정의 변화를 가져왔다. CAD/CAM 기술을 이용한 의치 제작 방식은 진료 및 기공 과정을 단순화하여 오류의 발생을 감소시키며, 임상적인 효율성과 편리함을 제공한다. 본 증례는 하악 편위를 가진 상·하악 완전 무치악 환자에서 광경화 SLA 기반의 3D 프린팅을 이용한 디지털 제작 방식의 양악 총의치 수복 증례이다. 구강 스캐너로 채득한 디지털 모형에서 기록상을 제작하였고 교합제에 악간관계를 기록한 후 부가 중합형 실리콘 인상재로 폐구 정밀 인상을 채득하였다. 또한 교합제를 장착하고 촬영한 안면 스캔 데이터를 추가로 획득하여 기공 작업 시 교합 평면 결정이나 인공치 배열에 참고할 수 있도록 하였다. 인상체를 3차원 스캔 후 CAD 프로그램을 통해 인공치를 배열하였고, 연마면을 형성하여 의치 디자인을 완성하였다. 시적 의치 및 최종 의치는 미국식품의약국(Food and Drug Administraion, FDA) 승인을 받은 액체 광경화성 레진을 이용하여 stereolithography (SLA) 기반 3D 프린터로 출력하였고, 최종 의치는 적절한 안정과 유지, 지지를 보였으며 기능적, 심미적으로 만족스러운 결과를 얻을 수 있었다.

• The Korean Journal of Physiology and Pharmacology
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• 제26권6호
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• pp.405-413
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• 2022

Hair loss is a common status found among people of all ages. Since the role of hair is much more related to culture and individual identity, hair loss can have a great influence on well-being and quality of life. It is a disorder that is observed in only scalp patients with androgenetic alopecia (AGA) or alopecia areata caused by stress or immune response abnormalities. Food and Drug Administration (FDA)-approved therapeutic medicines such as finasteride, and minoxidil improve hair loss temporarily, but when they stop, they have a limitation in that hair loss occurs again. As an alternative strategy for improving hair growth, many studies reported that there is a relationship between the expression levels of prostaglandins (PGs) and hair growth. Four major PGs such as prostaglandin D2 (PGD2₂), prostaglandin I2 (PGI₂), prostaglandin E2 (PGE₂), and prostaglandin F2 alpha (PGF_2α) are spatiotemporally expressed in hair follicles and are implicated in hair loss. This review investigated the physiological roles and pharmacological interventions of the PGs in the pathogenesis of hair loss and provided these novel insights for clinical therapeutics for patients suffering from alopecia.