• Title, Summary, Keyword: substantial equivalence

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Systematic Review on Clinical Equivalence of Generic and Brand-name Drugs in Statin Therapy (Statin 계열 약물의 제네릭 및 브랜드 제품 간 임상 치료결과 비교를 위한 체계적 문헌 고찰)

  • Shim, Haeri;Lee, Iyn-Hyang
    • 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.

Mutual Recognition of APEC Engineer (APEC ENGINEER 상호인정 제도)

  • 백이호
    • Proceedings of the Korean Geotechical Society Conference
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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.

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A Comparison Study on Accredited Architectural Education Contents between US and Korea

  • Kim, Jin-Wook
    • 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.

Effects of Diluents on Cellular Instabilities in Outwardly Propagating Spherical Syngas-Air Premixed Flames

  • Vu, Tran Manh;Park, Jeong;Kwon, Oh-Boong;Kim, Jeong-Soo
    • Proceedings of the Korean Society of Propulsion Engineers Conference
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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.

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Comparison of the Nutritional Compositions of Insect-Resistant and Glufosinate-Tolerant Rice and Conventional Rice

  • Park, Soo-Yun;Lee, Si Myung;Yeo, Yunsoo;Kweon, Soon Jong;Cho, Hyun Suk;Kim, Jae Kwang
    • 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.

A lumped parameter method of characteristics approach and multigroup kernels applied to the subgroup self-shielding calculation in MPACT

  • Stimpson, Shane;Liu, Yuxuan;Collins, Benjamin;Clarno, Kevin
    • 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.

Safety evaluation and approval status of genetically modified foods in Korea (국내 유전자변형식품 안전성 심사 규정 및 승인현황)

  • Kang, Yun-Sook
    • Food Science and Industry
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    • v.52 no.2
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    • pp.130-139
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    • 2019
  • Safety of genetically modified foods (GM foods) in Korea is evaluated according to "Food Sanitation Act" and "Regulation on safety evaluation for GM foods" based on the concept of substantial equivalence. In which cases a person who imports, develops or manufactures GM foods for the purpose of eating imports GM foods for the first time, he/she shall undergo a safety evaluation of the relevant foods, etc. by Ministry of Food and Drug Safety (MFDS). And in which cases ten years have elapsed since GM foods underwent safety evaluation, they shall be re-evaluated for their safety. As of April 2019, a total of 199 events have been approved by MFDS and they are 169 events of GM crops including soybean (29), maize (87), cotton (29), canola (14), sugar beet (1), potato (4), alfalfa (5), 6 events of GM microorganisms (GMM) and 24 events of GM food additives originated from GMM.

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Safety Assessment of Foods Produced Using Recombinant DNA Techniques

  • Toyoda, Masatake
    • 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.

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Genetically Modified Foods and Consumer Protection (유전자재조합식품과 소비자보호)

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    • Journal of Korean Home Management Association
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    • v.20 no.4
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    • pp.89-102
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    • 2002
  • Genetically modified foods may be defined as the foods deemed as safe by current technology among the many kinds of agricultural and stockbreeding products that are now under research and development using contemporary gene-modification techniques. This study examines hotly debated arguments, both for and against genetically modified- foods, in various countries. This study also investigates consumers'rights and responsibilities. Countries that are developing and exporting genetically modified organisms(GMO) have maintained that GMO can help produce more crops while reducing labor and other production-related costs, and that the genetically modified foods signify ″the second green revolution,″ which will solve future food and environmental problems by strengthening specific nutritive substances and extending shelf-life. But consumer groups, environmental organizations. and food-importing countries are more cautious about importing and consuming those foods because the potential dangers of GMO to human bodies and the environment have not been tested thoroughly yet. South Korea, following suit with others such as EU, Japan, Australia, and New Zealand, introduced a law on 'Labeling of Genetically Modified Foods', which went in effect in March, 2001, on the basis of customers'rights to make informed choices. The law takes the ″precautionary principle″ into consideration, rather than stopping at insuring ″substantial equivalence″ in developing and consuming GM foods. The actual impact of the law will depend on the level of citizens'Participation more than on the government's willingness to carry out the law. So far the level of Korean consumers'consciousness about genetically modified foods is very low. Therefore, it is hard to expect consumers to exercise their ″rights not to buy″ foods that are potentially unsafe. The Korean government must devise an effective plan to inform and educate the people about the labeling of genetically modified foods.

Bioequivalence of Commercially available Sustained Release Tablets of Diltiazem Hydrochloride (시판 염산 딜티아젬 서방형 정제의 생물학적 동등성)

  • Lee, Young-Bok;Koh, Ik-Bae;Seo, Se-Min;Yoon, Heong-Tung
    • Korean Journal of Clinical Pharmacy
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    • v.3 no.1
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    • pp.79-88
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    • 1993
  • Bioequivalence(BE) test of commercially available sustained release tablets of diltiazem hydrochloride(DTZ) was performed to give some guidelines to BE test in korea in case of which drugs with low oral bioavaiiability(BA) due to substantial first-pass hepatic loss form pharmacologically active metabolites. In such cases, the pharmacologic activity after oral administration is greater than anticipated from BA data, based on chemical assay of drug alone. Therefore, this paper explores the use and meaning of area under the plasma concentration-time(AUC) data of parent and its metabolites to access BA if sustained release tablets. Normal healthy male volunteers(n=14) were randomly divided into 2 groups, and sustained release reference$(Herbesser^{(R)})$ and test$(Herben^{(R)})$ tablets of DTZ-30mg were given orally by balanced two-period cross-over dosing schedule. The plasma concentration of DTZ and and its active metabolite, desacetyldiitiazem(DAD), were determined by high performance liquid chromatography, and, $AUC_{DTZ},\;AUC_{DAD},\;AUC_{DTZ+DAD},\;C_{max}\;and\;T_{max}$ obtained. Analysis of varlance(ANOVA) showed that $AUC_{DTZ}\;and\;C_{max}$ passed the standard $(\alpha=0.05,\;1-\beta\geq0.8,\;\Delta\leq0.2)$ of BE test of korea, but $AUC_{DAD}$ was not satisfied from the standpoint of power. On the other hand, $AUC_{DTZ\midDAD}$ may be more avaliable than $AUC_{DAD}$ from the standpoint of statistics and pharmacologic equivalence.

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