• Korean Journal of Clinical Pharmacy
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• v.27 no.2
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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.

• Proceedings of the Korean Geotechical Society Conference
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• 2001.03a
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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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• v.47 no.4
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• pp.261-272
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• 2020

Approvals for cultivation and import of genetically modified (GM) crops have dramatically increased around the world. Comparative compositional studies are an important aspect of safety assessments of products from GM crops and are based on substantial equivalence. Compositional analyses focus on determining similarities and differences between the compositions of the GM crops and their conventional counterparts, and thereby assessing the compositional equivalence of GM crops and their conventional comparators. The analytes, such as major constituents, key nutrients, and antinutrients, are generally determined on a crop-specific basis according to the OECD consensus document. The use of standard methods throughout the processes, such as selection of comparators, field trials, analytical methods, and statistical data analysis, is crucial. In this study, we showed the general framework of compositional studies. Literature for compositional studies of GM crops conducted abroad and in Korea was reviewed to obtain information about analytes, conventional counterparts, cultivation year, location, and statistical methods. The studies conducted abroad assessed for commercial release of GM crops such as soybean, maize, and cotton, while domestic studies were mainly performed for research in rice. In addition, we suggested a guidance for conventional comparators and field trials applicable to the domestic situation.

• Architectural research
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• v.13 no.2
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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.

• Proceedings of the Korean Society of Propulsion Engineers Conference
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• 2009.11a
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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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• v.56 no.1
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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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• v.49 no.6
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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.

• The Korean Journal of Community Living Science
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• v.15 no.4
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• pp.177-184
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• 2004

This study performed compositional analyses of a genetically modified herbicide-tolerant red pepper (GMHT), developed by the Rural Development Administration, and a parental red pepper cultivar 'Subicho', and compared the nutrient composition of them. Using the Association of Official Analytical Chemists (AOAC) methods, the study measured the concentration of nutrients, including the proximate components (protein, fat, fiber, ash, and carbohydrates) and minerals (Ca, K, Na, Fe, Mg, Zn) of GMHT and 'Subicho'. Nutritional composition of GMHT and 'Subicho' were compared with the nutritional composition of conventional red peppers. The nutrient composition of GMHT and 'Subicho' were found similar, and GMHT's nutrient contents were in the range of those of the conventional red peppers. These results showed that GMHT's nutrient contents were equivalent to those of the parental red pepper and other conventional red peppers.

• Toxicological Research
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• v.17
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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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• v.35 no.1
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• pp.13-21
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• 2008

Final regulatory steps for commercialization of transgenic crops are risk assessment and variety registration. The risk assessment of transgenic crops requires broad network of scientists, high cost and long term. Developers of transgenic crops, therefore, face to additional challenges to consider theoretical and strategic aspects on risk assessment. The general concept for risk assessment of genetically modified organisms was derived from chemical risk assessment. Due to the complexity of organisms, however, comparative approaches that are substantial equivalence and familarity have been developed. In practical view, the integration of risk assessment is more difficult than the evaluation of each risk factors involving gene flow, toxicity and allergenicity. Variety registration of transgenic crops requires the results of risk assessment compared with non-GM crops and agronomic data analyzed with standard varieties. For economic and fast commercialization, risk assessment process should combined with condition of cultivation test for variety registration.