• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• Journal of Plant Biotechnology
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• v.39 no.4
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• pp.295-299
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• 2012

We performed in vitro assay and field trials to assess levels of changes in intrinsic properties and resistance against soft rot of the potato cv. Dejima upon the introduction of a soybean calmodulin 4 gene (SCaM4). Field trials with four lines overexpressing SCaM4 gene were conducted over two seasons, and harvested tubers were evaluated in bioassay for resistance to Pectobacterium carotovorum ssp. carotovorum. The SCaM4 transgenic potato lines inoculated with $10^8$ CFU/ml of P. carotovorum ssp. carotovorum showed enhanced resistance compared to control. Among the SCaM4 transgenic lines, the transgenic line SCaM4-4 exhibited the highest tolerance to soft rot in vitro assays, so did in field trials. In the field trial, the soft rot resistance of SCaM4-4 line was more than 5 times higher compared to that of control cultivar, Dejima. The major agronomic characteristics of the SCaM4 transgenic lines were not different from those of the nontransgenic 'Dejima'. The result demonstrated that the transformation of a calmodulin 4 gene was a successful strategy in development of potato cultivar enhanced to soft rot.

• 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.

• Korea Trade Review
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• v.41 no.3
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• pp.135-156
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• 2016

This study, with reference to data on economic conditions in Shandong Province, China, looked into trade and investment activities in Korea and major cities of Shandong - Qingdao, Yantai, Weihai and Jinan - and investigated claim cases between the two countries by type. In addition, we investigated the matter empirically by conducting a survey administered to 300 Korean companies investing in Shandong Province and, based on the data, tested hypotheses for inferential analysis. The findings are as follows: i) while hypotheses in which the size of a firm, represented by import and export volume, has a positive relation with the frequency of trade claim filings (H1) and with the financial value of the trade claims (H2) were quoted, company size proved to have a significantly negative relation with the time required to obtain a claim decision, which rejects the third hypothesis (H3) in which the relation was thought to be positive: ii) while products, as represented by the type of business, showed a clearly significant difference with the frequency of trade claim filings (H4) and with methods of preventing and responding to claims (H6), they did not show a significant link to the type of trade claim (H5). This study is a theoretical and empirical overview of Korean companies based in Shandong Province of China, and can be used to address the practical needs of the Korean companies looking to start business in Shandong Province.

• Journal of Nutrition and Health
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• v.36 no.10
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• pp.1030-1035
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• 2003

This study was conducted to evaluate the safety of herbicide-resistant rice, a genetically modified organism (GMO) developed by the Rural Development Administration, in Sprague-Dawley rats. The nutrient content of herbicide-resistant polished and brown cooked rice was compared with that of conventional Ilpum polished and brown cooked rice to assess composition equivalence. Compositional analysis was performed to measure proximates, fiber, and minerals before animal feeding. Growing male rats were fed one of the following four diets for six weeks: Ilpum polished cooked rice (IP) and Ilpum brown cooked rice (IB) as a non-GMO and herbicide-resistant polished cooked rice (GP) and brown cooked rice (GB) as a GMO. We checked clinical symptoms (anorexia, salivation, diarrhea, polyuria, anuria, fecal change) every day, food intake, change of body weight twice a week, and serum biochemistry and organ weights after 6 weeks of experimental feeding among the four groups. Nutrient content of the herbicide-resistant rice was similar to that of the non-transgenic control and was within the published range observed for non-transgenic rice. We could not find any significant difference in the above-mentioned items as the index to be checked in the animals fed the GMO. These results suggest that the nutrient content of genetically modified herbicide-resistant rice is compositionally equivalent to that of conventional Ilpum rice and that growing male rats fed herbicide-resistant rice are no different from those fed Ilpum rice, non-GMO for 6 weeks.

• KDI Journal of Economic Policy
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• v.35 no.2
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• pp.71-105
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• 2013

Now that fiscal soundness is increasingly important influenced by the euro area fiscal crisis, early budget execution has been under the spotlight as a tool for economy control, other than typical expansionary method, such as supplementary budget. Basically, early budget execution is a fiscal policy instrument that reponses to economic fluctuations through modifying the inter-temporal allocation of fiscal expenditure within budget, without affecting fiscal soundness. This study empirically examines how effective the intert-temporal reallocation of fiscal expenditure is in economy control. Using Korea's Consolidated Fiscal data, the size of inter-temporal reallocation of fiscal expenditure is defined as changes of fiscal expenditure for one year excluding seasonal factors and used to explain real economic growth rate, a dependent variable. The result shows that the macroeconomic effect of the inter-temporal reallocation turns out meaningful in general, though some policy time lag exists. Meanwhile, a simulation using macroeconomic model finds that overall effect on economic growth is not large because increase in fiscal expenditure allocation at a certain point of time is canceled by the opposite direction within the same fiscal year. However, the inter-temporal reallocation is found to reduce volatility of key macroeconomic variables so as to contribute to partially stabilizing macroeconomy. In particular, such effect of economic stabilization seems to be highly apparent at the time of financial crisis, but not very noticeable in normal economic cycle.

• Resources Recycling
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• v.25 no.2
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• pp.49-59
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• 2016

Steel slag is being recycled into industrial by-products for civil generated inevitably in the seasonal course, road and cement raw materials. However, the field of recycling most of the bottom portion is concentrated in the areas that are required to take advantage of the situation in various fields taking advantage of the steel slag. But various studies to take advantage of the steel slag as aggregate for concrete made for limiting slag was a situation that most of the studies are incomplete research on the suitability of as aggregate for concrete practical relates to an expandable suppressed. In this study, the separation of the slag aggregate according to the production methods to assess the feasibility aggregate for concrete aggregates, including through Steel making slag, a total of seven kinds of steel slag aggregate. Studies show that ordinary concrete, steel slag aggregate for aggregate and on the equally to take advantage of grading, chloride content standards such as to what is lacking, although appropriate aggregate of concrete include the deployment of only in special sectors through the combination was assessed to have a very high.

• The Journal of the Korea Contents Association
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• v.17 no.12
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• pp.357-367
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• 2017

The study investigated information about the effects of message framing on colorectal cancer(CRC) screening related health beliefs and compliance with the CRC screening test within the theoretical framework of the prospect theory and the Health belief model (HBM). This study was using a non-randomized controlled quasi-experimental design. One hundred and sixty-four in the industrial workers who were currently nonadherent to guidelines for receiving screening were assigned to one of three experimental conditions: (a) gain-framed message, (b) loss-framed message, and (c) general-framed message. CRC screening-related health beliefs was self-reported after the intervention. And the immunoassay Fecal Occult Blood Test (iFOBT) kit was collected at 1 week. The research finding were analyzed by $x^2$ test and one-way ANOVA using SPSS 21.0. The loss-framed message group had higher perceived susceptibility, severity and benefit than the gain-framed message and general message. The participation rate for the immunoassay Fecal Occult Blood Test(iFOBT) was highest in the loss-framed message group. The loss framed messages more effective to enhance screening behavior. The present results provide a theoretical basis for developing educational guidelines for CRC testing and could be used for performing comprehensive approach by predicting and suggesting the practical effects according to message type in advance.

• Investigative Magnetic Resonance Imaging
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• v.5 no.1
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• pp.43-48
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• 2001

Purpose : To evaluate changes in rabbit liver parenchyma on MR images following percutaneous Holmium-166 injection, and to correlate those changes with histologic findings. Materials and methods. Holmium-166 (10-25 mCi) was percutaneously injected into the liver of rabbit (n=12) under sonographic guidance. MR images were obtained between one to two weeks (acute phasea) after the injection in four rabbits, and between two to four weeks (subacute phase) after the injection in four rabbits. Tissue specimens of these eight rabbits were obtained immediately after MR imaging. Tissue specimens were obtained without MR imaging in four rabbits (between one to two weeks in one rabbit and between three to four weeks in three rabbits). Results : Tissue specimens showed central liquefactive necrosis and peripheral coagulative necrosis containing deposition of small particles and hemorrhage. The peripheral margin of the lesions showed formation of the granulation tissue with fibrosis, which tended to be more prominent in subacute phase. The area of the necrosis tended to correlate with the dose of the radioactive Holmium-166. On MR images, the central portion of the necrosis showed hyperintensity on 72-weighted image, hypointensity on the precontrast T1-weighted images, and no enhancement on the dynamic MR images. The peripheral portion of the necrosis showed hypointensity on T2-weighted images, iso or mild hypointensity on the T1-weighted images, and mild peripheral enhancement on the delayed dynamic MR images. The peripheral margin of the lesion showed hypointensity on both T1- and T1-weighted images with increased enhancement on the delayed phase images of the dynamic MR images. Conclusion : After percutaneous Holmium-166 injection into rabbit liver parenchyma, the central portion showed liquefactive necrosis, the peripheral portion showed coagulative necrosis with granulation, fibrosis, hemorrhage and depostition of small granules. MR imaging may be helpful in evaluation of the histological change of the liver after percutaneous Holmium-166 treatment.

• Journal of Convergence Society for SMB
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• v.1 no.1
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• pp.19-28
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• 2011

In today and near future, most of the commercially manufactured IT products will be evolved into software convergence product. Recently, the embedded software products is called as 'Software Convergence Products.' This phenomenon does not simply show the trendy fashion, but has the seriously implication that the functionalities of IT product is accomplished and evolved via software technology, not via mechanical nor electrical means. It will become true that the quality of the convergence product is dominantly governed by the software it uses. Meanwhile, we are facing with the threatening fact that software defects in the mass products will requires tremendous amounts of cost proportional to the quantity of the product. We can remind ourselves of the disasters that have been already happened, such as Automotive recalls, Smart-phone recalls, and others. In software engineering, there have been large amount of work done in software quality improvement for the past couple of decades. Software process improvement, and testings are the representative ones. But we are facing with limitations of those traditional approaches in current convergence industry; exponentially increasing software sizes and rapid changes in software technology. In this paper, we analyze the characteristics of the software convergence industry, the limitations of the traditional Software quality improvement approaches. We suggest a new approaches in software quality improvement in different angles of thought and philosophy.