• 한국임상약학회지
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• 제27권2호
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• pp.105-112
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• 2017

Background: Generic medications are approved on the basis of bioequivalence with brand medications in healthy volunteers rather than the target population, there remains a substantial uncertainty regarding their clinical effectiveness and safety. The object of this paper is to compare the clinical equivalence of generic statin drugs in patients. Methods: Literature published before September 2016, which is indexed in PubMed, EMBASE, RISS, comparing generic to brand products in statins. Outcomes included blood lipid level, proportion of days covered (adherence), hospitalization and mortality. Results: 511 citations were screened, of which 11 studies met eligibility criteria (6 randomized clinical trials, 5 observational studies). Generic atorvastatin was clinical equivalent with brand drugs in blood lipid level (3 RCTs) and generic simvastatin was also clinical equivalent with brand drugs (2 RCTs). 2 of 3 studies reported no significant difference in proportion of days covered except 1 study which reported generic statin significantly enhance proportion of days covered (p<0.001). Hospitalization was no significant difference in all studies (p>0.05). 1 study reported that all cause of mortality was significantly low in generic drugs (p<0.0001). Conclusion: Published data on comparing clinical efficacy of generic and brand statins were insufficient in both quantity and quality. This systematic review suggests that additional studies on clinical equivalence and safety of generic medications in patients would be needed.

• 한국지반공학회:학술대회논문집
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• 한국지반공학회 2001년도 봄 학술발표회 논문집
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• pp.3-14
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• 2001

This study introduces the framework of the mutual recognition project of APEC Engineer and also tries to find out what we, Korean engineers have to do with this project. The mutual recognition framework consists of 2 main frameworks ; the substantial equivalence framework and the mutual exemption framework. The participating Economies have discussed and agreed on the framework of the substantial equivalency and have been producing APEC Engineers from the 1st, Nov 2000 based on this agreement. However, more discussions will be required from now on in order to finalize the mutual exemption agreement, even though there have been a lot of discussions including the workshop for the regulatory authority for the last 5 years. Here we have to study and find out what we have to do with this project and prepare for the bilateral agreements and the Coordinating Committee meeting to be held in Hongkong in Oct this year.

• Journal of Plant Biotechnology
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• 제47권4호
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• pp.261-272
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• 2020

전세계적으로 유전자변형(GM)작물의 재배와 수입에 대한 승인이 급격히 증가하고 있다. 영양성분 비교평가는 실질적 동등성에 기반하여 GM작물의 안전성 평가에서 중요한 역할을 담당하고 있다. 영양성분 비교평가는 GM작물과 대조작물 사이의 성분함량에서 차이와 유사성을, 그리고 GM작물과 상업품종간의 성분함량의 동등성을 결정하는데 중점을 두고 있다. 분석항목은 일반성분, 주요 영양성분과 항영양소 등이며 일반적으로 OECD 합의문에서 작물별로 제안하고 있는 항목들을 포함한다. 영양성분 비교평가를 위해서는 비교군의 선정, 포장 시험, 분석방법, 데이터 통계 처리 등의 전 과정에 걸쳐 표준화된 방법을 이용하는 것이 중요하다. 본 연구에서는 코덱스와 유럽식품안전청의 식품용 GM작물의 영양성분 비교평가를 위한 가이드라인을 소개하였다. 그리고 국내외의 GM작물 영양성분 비교평가 연구 논문들에 나타난 분석항목과 대조작물, 참조군 품종, 재배연도, 재배지역, 통계방법 등을 검토하였다. 해외의 경우 대두와 옥수수, 면화 GM작물에서 여러 나라 수출을 위한 규제기관의 가이드라인에 따른 연구가 많았다. 반면 국내의 경우는 GM작물 실험연구적 측면에서 비교평가 진행되었으며 주로 GM벼에서의 연구가 많았다. 마지막으로 국내에서 GM작물의 영양성분 비교평가 연구 수행에 적용할 수 있는 참조군 선정과 포장재배에 대한 가이드를 제시하였다.

• Architectural research
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• 제13권2호
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• pp.13-21
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• 2011

Since 2002, Architecture Schools in Korea was changing long traditional architectural education system from 4 years generalized architectural engineering curriculum to 5 years professional architecture program. Until 2010, 76 architecture schools have changed their program to 5 years course which was focused to design studio education. It was a very rapid change and there was not much time develop their own system which could represent institutional identity, character of students and local environment. Korea joined as a regular member of Canberra Accord in 2010 and it is meaningful to compare Korean architecture program contents to another country education contents. US architecture programs were selected for this comparison study. The goals of this study are to create a comparable understanding the form of contents of Architectural Education in US and Korea and to verify the substantial equivalence of these systems. To achieve above goals, three public institutes of each country were selected and analyzed with general information, history, resources, curriculum and the matrix of Student Performance Criteria for quantitative comparison. For qualitative comparison education context of programs were analyzed with program missions, the way of advising, professional connection and distribution of faculty loads.

• 한국추진공학회:학술대회논문집
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• 한국추진공학회 2009년도 제33회 추계학술대회논문집
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• pp.191-196
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• 2009

Experiments were conducted in a constant pressure combustion chamber using schlieren system to investigate the effects of carbon dioxide/nitrogen/helium diluents on cellular instabilities of syngas-air premixed flames at room temperature and elevated pressures. Laminar burning velocities and Markstein lengths were calculated by analyzing high-speed schlieren images at various diluent concentrations and equivalence ratios. Experimental results showed substantial reduction of the laminar burning velocities and of the Markstein lengths with the diluent additions in the fuel blends. Effective Lewis numbers of helium-diluted syngas-air flames increased but those of carbon dioxide- and nitrogen-diluted syngas-air flames decreased in increase of diluents in the reactant mixtures. With helium diluent, the propensity for cells formation was significantly diminished, whereas the cellular instabilities for carbon dioxide-diluted and nitrogen-diluted syngas-air flames were not suppressed.

• Journal of Applied Biological Chemistry
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• 제56권1호
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• pp.5-9
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• 2013

The nutritional composition of transgenic rice (Agb0101) with bar and modified cry1Ac1 genes grown with herbicides was compared with that of its non-transgenic counterpart. The analyzed components (proximates, amino acids, fatty acids, minerals, vitamins, trypsin inhibitors, and phytic acid) in the herbicide-treated Agb0101 brown rice were substantially equivalent to those of its non-transgenic counterpart.

• Nuclear Engineering and Technology
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• 제49권6호
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• pp.1240-1249
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• 2017

An essential component of the neutron transport solver is the resonance self-shielding calculation used to determine equivalence cross sections. The neutron transport code, MPACT, is currently using the subgroup self-shielding method, in which the method of characteristics (MOC) is used to solve purely absorbing fixed-source problems. Recent efforts incorporating multigroup kernels to the MOC solvers in MPACT have reduced runtime by roughly $2{\times}$. Applying the same concepts for self-shielding and developing a novel lumped parameter approach to MOC, substantial improvements have also been made to the self-shielding computational efficiency without sacrificing any accuracy. These new multigroup and lumped parameter capabilities have been demonstrated on two test cases: (1) a single lattice with quarter symmetry known as VERA (Virtual Environment for Reactor Applications) Progression Problem 2a and (2) a two-dimensional quarter-core slice known as Problem 5a-2D. From these cases, self-shielding computational time was reduced by roughly $3-4{\times}$, with a corresponding 15-20% increase in overall memory burden. An azimuthal angle sensitivity study also shows that only half as many angles are needed, yielding an additional speedup of $2{\times}$. In total, the improvements yield roughly a $7-8{\times}$ speedup. Given these performance benefits, these approaches have been adopted as the default in MPACT.

• 한국지역사회생활과학회지
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• 제15권4호
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• pp.177-184
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• 2004

본 연구는 농촌진흥청에서 개발한 유전자 변형(제초제 저항성) 고추와 모종인 수비초 고추의 영양성분을 분석하고 유전자 변형된 경우 영양성분에 차이가 있는지 비교하기 위하여 수행하였다. 영양성분은 AOAC법을 이용하여 주요 영양소(단백질, 지방, 섬유소, 회분, 당질)와 무기질(칼슘, 칼륨, 나트륨, 마그네슘, 아연, 철) 함량을 분석하였고, 식품성분표에 제시된 일반 고추의 영양성분과 비교하였다. 그 결과 유전자 변형 고추는 모종 고추와 영양성분 함량이 유사하였고, 일반적인 고추의 영양성분 함량 범위 내에 있어 실질적인 동등성을 갖는 것으로 나타났다.

• Toxicological Research
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• 제17권
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• pp.167-171
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• 2001

The introduction of genetically modified crops has raised concerns regarding safety issues over the insertion of foreign genes into plant genomes using recombinant DNA technology. Since 1991 in Japan, 29 foods and 6 food additives have been evaluated, based on the "Guideline for Safety Assessment", before these foods were marketed. The MHW, however, decided that safety assessment of such foods and food additives should be legally imposed. because soon such foods and food additives are expected to circulate globally and a new system for assessing safety of such foods and food additives at a pre-market stage is necessary, in order to avoid the distribution of any genetically modified foods that have had no safety assessment. The MHW published relevant announcements to amend existing regulations on 1 May 2000. "Standards for safety assessment of seed plant" is established based on a concept of substantial equivalence, and applicable to the products which are regarded as equivalent to the existing products used as foods and food additives. The characterization of the food products entails consideration of the molecular characterization. phenotypic and compositional characteristics, key nutrients and toxicants, and toxicity and allergenicity of the introduced proteins, and if there are indications of unintended effects of the modification, whether further safety testing (animal studies etc.) is needed should be considered. Safety and wholesomeness studies with whole foods should be care fully designed in order to avoid nutritional imbalances causing artifacts and uninterpretable results as was the case of Dr. Pusztaiis report. A case study of genetically modified soybeans (glyphosate-tolerant soybeans) on the immune system of rats and mice is shown. Chemical compositions were also compared with those of the non-GM soybeans. The studies failed to detect any differences in immuno-toxic activity.muno-toxic activity.

• Journal of Plant Biotechnology
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• 제35권1호
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• pp.13-21
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• 2008

형질전환작물 상업화의 최종 규제단계는 위해성심사와 품종출원이다. 위해성심사를 위한 형질전환작물의 위해성 평가는 광범위한 과학자 네트워크, 고비용과 오랜 기간을 필요로 한다. 따라서 형질전환작물 개발자는 우수한 형질의 개발 이외에 위해성평가에 대한 이론적 및 전략적 측면을 부가적으로 고려해야 한다. 유전자변형생물체의 위해성평가에 대한 일반적인 개념은 화학물 위해성평가로부터 유래하였다. 그러나 생물체가 가지는 복잡성 때문에 실질적동등성과 친숙성으로 대표되는 비교접근 방법이 개발되어 왔다. 실제적인 측면에서 통합적인 위해성평가는 유전자이동성, 독성과 알레르기와 같은 개별 위해성평가보다 더 어렵다. 형질전환 계통의 품종출원을 위해서는 위해성평가 단계에서부터 품종보호요건을 고려한 평가자료 생산과 위해성 심사 승인 계통을 이용한 다양한 LMO 품종 육종전략이 필요하다.