• Journal of Pharmaceutical Investigation
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• v.36 no.6
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• pp.421-435
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• 2006

The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation(EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply. In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause my public health concerns. In fact, the post-authorisation guidance categorizes post-approval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-frame. The thrust of the EU's post-authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.

• The Journal of Asian Finance, Economics and Business
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• v.7 no.1
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• pp.229-238
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• 2020

A model is presented in this paper to provide understanding of the supply chain integration and supply chain information practices' impact on the manufacturing industries. The supply chain information practices play a crucial role in sharing information between the members of SC network. Thus, it is important to develop a comprehensive understanding of the differences and similarities among ISI and information management. It will allow firms to systematically evaluate and carefully choose the information strategy. The empirical findings of this research offer essential and interesting insights about what role SCI, supply chain information and Supply chain ISI play in determining Malaysia's financial performance. The theoretical gaps addressed in this study are of significant importance, since a little empirical evidence is available regarding system infrastructure and supply chain information management's effectiveness. This research provides further paths of exploring system infrastructure and information management, thereby defining the manufacturing industries' next step in SCM struggle i.e. modifying total integrated SC principle in other manufacturing firms. The Resource-based theory discovered organizational resources as an essential organizational success ingredient. Therefore, in order to recognize its potential value, internal resources, for instance, information system and management must be fully utilized.

• Journal of Distribution Science
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• v.15 no.12
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• pp.21-30
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• 2017

Purpose - This research approaches to the new niche market of medical tourism to investigate how factors of cultural similarity influence the international distribution management. This study also estimates the interaction effects of distribution channel on the relationships of facility attributes and customers' destination choice behavior. Research design, data, and methodology - We collected the sample of 881 potential customers from the more economically developed regions in China. Regression analysis is used to confirm the relationships in the research model. Results - The result shows that cultural similarity plays an important moderating role in the relationships of facility attributes and destination choice intention. For instance, power distance and masculinity interact with the distribution facility characteristics of medical quality and reputation to influence customers' selection of the destination country. Individualism, powder distance, and masculinity play moderating roles when social environment affects destination choice intention. Especially, all the elements of cultural similarity moderate the relationships between travel cost and destination choice intention. This research also proves that depending on distribution channel, determinants of distribution facility are the critical predictors of intention to select the medical service outside of China. Conclusions - The study enables managers to develop the more effective strategies reflecting the interaction effects of cultural similarity and distribution channel on customers' decision-making process.

• ETRI Journal
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• v.34 no.1
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• pp.24-34
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• 2012

In this paper, the directional carrier sense multiple access/collision avoidance (CSMA/CA) protocol in the immediate acknowledgement mode for IEEE 802.15.3c is analyzed under saturation environments. For the analysis, a sensing region and an exclusive region with a directional antenna are computed probabilistically and a Markov chain model in which the features of IEEE 802.15.3c and the effects of using directional antennas are incorporated is analyzed. An algorithm to find the maximal number of concurrently transmittable frames is proposed. The system throughput and the average transmission delay are obtained in closed forms. The numerical results show the impact of directional antennas on the CSMA/CA media access control (MAC) protocol. For instance, the throughput with a small beamwidth of antenna is more than ten times larger than that for an omnidirectional antenna. The overall analysis is verified by a simulation. The obtained results will be helpful in developing an MAC protocol for enhancing the performance of mmWave wireless personal area networks.

• Proceedings of the Korean Society for Technology of Plasticity Conference
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• 2000.04a
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• pp.75-78
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• 2000

There are several effective factors to influence die life in the warm forging process. For instance process design die design and die materials etc This study presented heat treatment method which could improve toughness and wear resistance simultaneously in high temperature to apply high speed tool steels like SKH51 to die material for warm forging process. To verify the feasibility of application of heat treatment method mentioned above wear test was performed under the condition of constant time in 40$0^{\circ}C$ Wear coefficient was examined to search a relation between wear amount and time for each material and heat treatment method in 30, 60, and 130 minutes. To quantify the toughness-behavior between room and high temperature impact test was performed and heat fatigue test also fulfilled to compare with the resistance of heat check in room, 200, 400, and $600^{\circ}C$ temperature. On the basis of experimental results mentioned above high speed tool steel was applied to verify appropriateness of newly proposed heat treatment method for die of rotor pole used in automobile alternator. As a result die life of high speed tool steel applied newly proposed heat treatment is longer than that of STD61.

• Journal of Distribution Science
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• v.11 no.11
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• pp.57-61
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• 2013

Purpose - This study aimed to understand the influence of visible factors directly shown to and experienced by consumers such as physical evidence, and invisible factors obtained through acquaintances or other experienced consumers such as word-of-mouth, in the discount stores' marketing communication on impulse buying intention and store loyalty. Research Design, Data, and Methodology - This study examined the effect of factors in discount stores' marketing communication, for instance, physical evidence, word-of-mouth, and buying impulse intention. The questionnaire survey resulted in 68 completed questionnaires. Results - Physical evidence and word-of-mouth have a statistically significant positive effect on store loyalty. The results of regression analysis regarding whether visible or invisible factors have more impact showed that word-of-mouth has a statistically significant positive effect on store loyalty. With regard to impulse buying intention, only word-of-mouth was statistically significant. Conclusion These results suggested that visible and invisible factors that appeal to customers are very important. In particular, the results suggested that stores should create invisible factors (e.g., positive word-of-mouth) for their customers.

• Journal of the Korean Society of Propulsion Engineers
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• v.10 no.2
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• pp.115-128
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• 2006

A technical analysis of current scramjet and combined-cycle engine is presented. Substantial research has been pursued to characterize the operation mechanism of scramjet propulsion, especially in the areas of flame stabilization and system integration, dramatically over the years in support of both military and space access application. Major technology that had significant impact on the maturation of scramjet propulsion technology are dual combustion ramjet, dual mode ramjet, and combined cycle engine to cover a typical wide rage of flight, up to flight Mach number 10. Notable are the fundamental and practical techniques, for instance, scram propulsion itself, thermal relaxation and protection using endothermic fuel and/or CSiC composit materials, and design/manufacture of movable intake and nozzle, to realize high speed propulsion system in near future.

• Journal of the Korea Safety Management & Science
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• v.17 no.2
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• pp.89-96
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• 2015

The weapon systems development has some distinct characteristics in that a big size of government budget (derived from national tax) has been expended frequently and the completion of the development projects seems to take long. Thus, the impact of the potential changes in the required operational capability on the development activities can induce some type of project risks. As such, proper management of project risk has been one of crucial subjects in the weapon systems development. Although a variety of methods can be considered, an approach based on the test and evaluation (T&E) process has been selected in this paper in order to appropriately handle those potential risks. In the study of the underlying T&E process, the safety consideration (for instance, explosiveness) of weapon systems is also included. To achieve the objective of the paper, a step-by-step procedure is first presented in the analysis of the T&E process. Then, to pursue some enhancement on the process, a set of necessary and useful activities are added in terms of risk and safety management. The resultant process is further analyzed and tailored based on a design structure matrix method. The case study of a tank development is also discussed.

• Nuclear Engineering and Technology
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• v.50 no.3
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• pp.494-503
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• 2018

As public acceptance of nuclear energy in Korea worsens due to the Fukushima accident and the earthquakes that occurred in the Gyeongju area near the Wolsong nuclear power plant (NPP), estimating the effects of earthquakes has become more essential for the nuclear industry. Currently, most countermeasures against earthquakes are limited to large-scale disasters. Minor-scale earthquakes used to be ignored. Even though people do not feel the shaking due to minor earthquakes and minor earthquakes incur little damage to NPPs, they can change the environmental conditions, for instance, underground water level and the conductivity of the groundwater. This study conducted a questionnaire survey of residents living in the vicinity of an NPP to determine their perception and acceptance of plant safety against minor earthquakes. The results show that the residents feel earthquakes at levels that can be felt by people, but incur little damage to NPPs, as minor earthquakes (magnitude of 2.0-3.9) and set this level as a standard for countermeasures. Even if a minor earthquake has little impact on the safety of an NPP, there is still a possibility that public opinion will get worse. This study provides analysis results about problems of earthquake measures of Korean NPPs and specific things that can bring about an effect of deterioration of public acceptance. Based on these data, this article suggests that active management of minor earthquakes is necessary for the sustainability of nuclear energy.

• Microbiology and Biotechnology Letters
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• v.49 no.2
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• pp.249-254
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• 2021

The study of the impact of weather on viral respiratory infections enables the assignment of causality to disease outbreaks caused by climatic factors. A better understanding of the seasonal distribution of viruses may facilitate the development of potential treatment approaches and effective preventive strategies for respiratory viral infections. We analyzed the incidence of human mastadenovirus infection using real-time reverse transcription polymerase chain reaction in 9,010 test samples obtained from Cheonan, South Korea, and simultaneously collected the weather data from January 1, 2012, to December 31, 2018. We used the data collected on the infection frequency to detect seasonal patterns of human mastadenovirus prevalence, which were directly compared with local weather data obtained over the same period. Descriptive statistical analysis, frequency analysis, t-test, and binomial logistic regression analysis were performed to examine the relationship between weather, particulate matter, and human mastadenovirus infections. Patients under 10 years of age showed the highest mastadenovirus infection rates (89.78%) at an average monthly temperature of 18.2℃. Moreover, we observed a negative correlation between human mastadenovirus infection and temperature, wind chill, and air pressure. The obtained results indicate that climatic factors affect the rate of human mastadenovirus infection. Therefore, it may be possible to predict the instance when preventive strategies would yield the most effective results.