• 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.

• Journal of Construction Engineering and Project Management
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• v.3 no.3
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• pp.35-41
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• 2013

All infrastructure projects are said to be inter-dependent, uncertain and labour-intensive in nature. There is no exception for building services sub sector. For a real time project such as 'The construction, extension and refurbishment of Employees' State Insurance Corporation (ESIC) Hospital at Tirupathy, India with total area of 45,000 square feet at an estimated cost of 1100 million rupees, a generic process model is developed to simulate the effect of set of identified variables on construction project. The 'Stocks and Flows' of dynamic model affords relevant insights to project managers, who apply this knowledge when designing better performance through more appropriate project planning. It is concluded from the model-based approach that building services works can be improved through specific better focussed managerial efforts, such as an increasing coordination effectiveness at the planning stage, clarifying prerequisite conditions prior to installations. Otherwise, pending works arising from work clashes can lead to knock-on effects resulting in productivity constraints and pressures, as well as more rework and demolition. Current study reveals that the model enables deep insight into various interdependent processes, their by improving construction performance levels, by addressing the dynamics of design errors and defective works, and recovering delayed schedule.

• Journal of the Korean Operations Research and Management Science Society
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• v.37 no.3
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• pp.57-68
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• 2012

The recent proliferation of various smart devices like the smartphone, tablet PC, and smart TV enables consumers to download various applications from the network and to access private files stored in their desktop server at any time and at any place. The trend of ubiquitous access seems to have become stronger and more diversified toward a ubiquitous network computing environment with the aggressive deployment of commercial cloud services. Recently, many Korean network service providers launched commercial B2C public cloud services, which were widely adopted by smart device users. They include Daum cloud, N drive, ucloud, and uplus box, mostly provided by major Korean telecom companies and portals. This paper aims to explore consumers' adoption behaviors toward the B2C public cloud services that were recently deployed in the Korean market. In order to achieve the goal, we identified key influencing factors that affect the consumers' adoption behaviors, based on an extension of the technology acceptance model (TAM). Several hundred smart device users were surveyed to test the generic regression model with the extended set of TAM variables.

• Korean Journal of Computational Design and Engineering
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• v.13 no.5
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• pp.334-341
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• 2008

Computer-aided engineering (CAE) analysis is considered essential for product development because it decreases the simulation time, reduces the prototyping costs, and enhances the reusability of product parts. The reuse of quality-assured CAE data has been continually increasing due to the extension of product lifecycle management; PLM, which is widely used, shortens the product development cycle and improves the product quality. However, less attention has been paid to systematic research on the interoperability of CAE data because of the diversity of CAE data and because the structure of CAE data is more complex than that of CAD data. In this paper, we suggest a CAE data exchange method for the effective sharing of geometric and analysis data. The method relies on heterogeneous CAE systems, a virtual reality system, and our developed CAE middleware for CAE data exchange. We also designed a generic CAE kernel, which is a critical part of the CAE middleware. The kernel offers a way of storing analysis data from various CAE systems, and, with the aid of a script command, enabling the data to be translated for a different system. The reuse of CAE data is enhanced by the fact that the CAE middle-ware can be linked with a virtual reality system or a product data management system.

• Wind and Structures
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• v.17 no.3
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• pp.275-298
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• 2013

This paper presents a number of approximated analytical formulations for the flutter analysis of long-span bridges using the so-called uncoupled flutter derivatives. The formulae have been developed from the simplified framework of a bimodal coupled flutter problem. As a result, the proposed method represents an extension of Selberg's empirical formula to generic bridge sections, which may be prone to one of the aeroelastic instability such as coupled-mode or single-mode (either dominated by torsion or heaving mode) flutter. Two approximated expressions for the flutter derivatives are required so that only the experimental flutter derivatives of ($H_1^*$, $A_2^*$) are measured to calculate the onset flutter. Based on asymptotic expansions of the flutter derivatives, a further simplified formula was derived to predict the critical wind speed of the cross section, which is prone to the coupled-mode flutter at large reduced wind speeds. The numerical results produced by the proposed formulas have been compared with results obtained by complex eigenvalue analysis and available approximated methods show that they seem to give satisfactory results for a wide range of study cases. Thus, these formulas can be used in the assessment of bridge flutter performance at the preliminary design stage.

• Steel and Composite Structures
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• v.30 no.6
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• pp.517-534
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• 2019

In this paper, the effects of inevitable out-of-plane defects on the postbuckling behavior of single-layered graphene sheets (SLGSs) under in-plane loadings are investigated based on nonlocal first order shear deformation theory (FSDT) and von-Karman nonlinear model. A generic imperfection function, which takes the form of the products of hyperbolic and trigonometric functions, is employed to model out-of-plane defects as initial geometrical imperfections of SLGSs. Nonlinear equilibrium equations are derived from the principle of virtual work and variational formulation. The postbuckling equilibrium paths of imperfect graphene sheets (GSs) are presented by solving the governing equations via isogeometric analysis (IGA) and Newton-Raphson iterative method. Finally, the sensitivity of the postbuckling behavior of GS to shape, amplitude, extension on the surface, and location of initial imperfection is studied. Results showed that the small scale and initial imperfection effects on the postbuckling behavior of defective SLGS are important and cannot be ignored.

• Journal of Korea Multimedia Society
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• v.2 no.4
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• pp.476-489
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• 1999

HW/SW codesign is integrated design of systems implemented using both hardware and software components. Many design tools has been developed to support this new paradigm, so far. Current codesign tools are not widely used as been expected because of variety problems - rapidly evolving technology, platform dependency, absence of standard specification method, inconsistent user interface, varying target system, different functionality In this paper, we propose a web-based distributed HW/SW codesign environment to remedy this kinds of problem. Our codesign environment has object-based 3 tier client/server architecture. It supports collaborative workspace through session service. Fully object-oriented design of user interface(OOUI) enables easy extension without change of user Interface. Furthermore it contains transaction server and security server for efficient and safe transfer of design data. To show a validity of our design, we developed prototype of web-based HW/SW codesign environment called WebCEDA. Our model of HW/SW codesign can be used for web-based generic CAD tools.

• Journal of KIISE:Information Networking
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• v.35 no.3
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• pp.183-191
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• 2008

In this paper, we propose Stream Control Transmission Protocol(SCTP) proxy which supports making an SCTP connection from a Corresponding Node(CN) to a Mobile Node(MN). Recently, mobility support in transport layer is proposed, which provides mobility in end-to-end way using the extension of SCTP. Mobile SCTP can provide handover to all applications that use SCTP as a transport protocol. However, current SCTP does not include independent location management service and can not make connection from a CN to a MN without assistance of other mobile protocols. To solve this problem, Proposed SCTP proxy interoperates with generic location management service and performs an address transformation to forward connection set up messages to the MN. Using the proposed proxy, SCTP can provide a complete mobility support including a connection setup to the MN and maintaining an existing connection.

• The Korean Journal of Food And Nutrition
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• v.26 no.3
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• pp.553-564
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• 2013

The core ingredient of traditional Korean style soy sauce is soy bean without any wheat or rice incorporated. National brands as well as regional micro-brewed companies constitute the soy sauce market in Korea. The present study investigated the physico-chemical and sensory properties of soy sauces produced by small-scale or mass-production. Additionally, the key physico-chemical parameters sufficiently representing the critical sensory characteristics have been identified. Ten types of soy sauce brewed by the Korean traditional method were selected for the study. Among these samples, seven types were brewed in small-scales in the Gyeonggi-do region whereas the other 3 types were mass-production products of major national brands. The total solid, reducing sugar, salinity, sugar content, amino nitrogen, CIELAB, acidity, and pH of soy sauce samples were measured for the physico-chemical analysis. A generic descriptive analysis was conducted to analyze the sensory characteristics of the samples using six trained panelists. The descriptive panel developed 21 sensory attributes. The data were statistically analyzed using ANOVA, PCA and PLSR. Overall, the micro-brewed products showed significantly higher value of salinity and acidity but lower content of reducing sugar than the mass-production products. The micro-brewed soy sauces elicited stronger fermented flavor, sourness, and bitterness whereas the national brand products elicited stronger alcoholic odor, sweetness and umami taste. Sugar content, acidity, and amino nitrogen showed strong relationships with fish sauce flavor, umami taste, and rich flavor. Salinity was closely related to the overall flavor intensity.

• Journal of the Institute of Electronics Engineers of Korea SP
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• v.44 no.5
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• pp.54-63
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• 2007

The purpose of this study is to present a new energy minimization method for image completion with hierarchical approach. The goal of image completion is to fill in missing part in a possibly large region of an image so that a visually plausible outcome is obtained. An exemplar-based Markov Random Field Modeling(MRF) is proposed in this paper. This model can deal with following problems; detection of global features, flexibility on environmental changes, reduction of computational cost, and generic extension to other related domains such as image inpainting. We use the Priority Belief Propagation(Priority-BP) which is a kind of Belief propagation(BP) algorithms for the optimization of MRF. We propose the hierarchical Priority-BP that reduces the number of nodes in MRF and to apply hierarchical propagation of messages for image completion. We show that our approach which uses hierarchical Priority-BP algorithm in image completion works well on a number of examples.