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

• Korean Journal of Human Ecology
• /
• v.22 no.3
• /
• pp.473-483
• /
• 2013

This study analyzed the consumer consulting type about cosmetics, and examined the characteristics of the consumer consulting type. The data used for the analysis are 7,126 consumer consulting cases of cosmetics, which had been applied for the consumer counseling centers, from July 2010 to June 2011. Through the consumer consulting paper, the consumer consulting types were divided into as follows : purchase, delivery, quality, product, product display and advertising, services, after purchase, simple consulting, seller's unfair bill, and other types of consulting. According to the results of the analysis, consumers were anxious about cosmetics quality and safety, and they also wanted objective information on cosmetics. Consumer consulting type were significantly different by ages. 63.3% of teenagers were consulting about purchase problem. 31.5% of the 20's were consulting about quality, and 26.0% were consulting about purchase. 30's, 40's, more than 50's groups mostly were consulting about quality. Based on that, this study suggests about policy and consumer education for how to use and purchase the cosmetics correctly.

• The Korean Journal of Ceramics
• /
• v.6 no.1
• /
• pp.32-36
• /
• 2000

Pyrolytic preparations of Ti-Al-N ceramics from three blended precursors were investigated. The precursors were prepared stirring ($HA1N^{i}Pr_m$ and an aminolysis product of $Ti(NMe_2)_4$ with $MeHNCH_2CH_2$NHMe in $C_6/H_6$ . IR and $^1H\;NMR $analyses suggested that essentially no Ti-N-Al bonds were present in the precursors. Pyrolysis of the precursors under $NH_3-N_2$led to the formation of brown solids with ceramic yields of about 30%, and the Ti-Al ratios in the pyrolyzed products were close to those of the precursors. XRD analysis of the pyrolyzed product from the precursor with Ti:Al=5:1 indicated the formation of a NaCl-type compound as the only crystalline phase. Pyrolysis of the precursor with Ti:Al=2:1 led to the formation of AlN besides the major NaCl-type compound. A ceramic composite containing AlN and the NaCl-type compound was formed by pyrolysis of the precursor with Ti:Al=1:2.

• International Journal of Advanced Culture Technology
• /
• v.6 no.3
• /
• pp.129-141
• /
• 2018

As the scope of social expectations and roles in the design field has expanded, the demand for education to cope with changes in the technology environment is increasing in design education. In response to this trend, microcontroller board-type design-prototyping tools have also been introduced into design education, and much educational content is being developed. However, there is the perception that students who are majoring in design without engineering knowledge are still barred from entry. A variety of educational content and tools have been developed to solve these difficulties, although there are several limitations to their practical application. Especially, in the design education courses in universities, the functional expectation level for prototyping is high, but most of the content developed for solving the difficulties has been developed for the lower education levels, and it could be said that a great deal of learning is necessary to solve the problem. In this study, students were asked about microcontroller board utilization and their satisfaction with their design through questionnaires and with the developed microcontroller board development direction via Focus Group Interviews. Based on this, we tested microcontroller boards that eliminate the coding process and which students can use to create and prototype their work as a suggestion to fulfil demand. After using the board, both the usability and improvement of the product were checked. Confirmation of the usefulness of the free- coding-type microcontroller was obtained through this study along with the possibility of responding to various educational demands by applying the application design related to this product.

• Journal of the Korean Home Economics Association
• /
• v.41 no.11
• /
• pp.11-20
• /
• 2003

The purpose of this study is : first, to examine factors of fashion show planning and production and to classify types of fashion show planning and production: second, to compare and analyze the factors through a case analysis to defined their differences. For the purpose, data are collected to compare and analyze from literature as well as the interview with fashion show planning and production companies in Korea. The result shows that all the factors are considered on a practical level except security and publicity among 15 factors presented in literature : the purpose of the show, target spectators, product selection, product prices, type of show, size, location, models, time of show, duration, theme, security, budget, and publicity. Show types are divided into national brands, designer brands, imported brands, and collections. The result of the comparison and analysis of the factors of the planning and production by type shows that factors vary greatly depending on the purpose of the show, target spectators, and form of the show and products. By analyzing the case study on fashion show planning and production on a practical level, the study recognizing the need of specialized development of fashion show planning in Korea's fashion industry, is a basic process of theory systematization for the planning and production in its marketing aspects, and will provide relevant theories in such aspects for those who want to enter into the field.

• Journal of Distribution Science
• /
• v.18 no.10
• /
• pp.65-75
• /
• 2020

Purpose: This study aims to examine how to review contents of experiential and utilitarian products (e.g., skincare products) and how to affect review helpfulness by applying natural language processing techniques. Research design, data, and methodology: This study uses 69,633 online reviews generated for the products registered at Amazon.com by 13 Korean cosmetic firms. The authors identify key topics that emerge about consumers' use of skincare products such as skin type and skin trouble, by applying bigram analysis. The review content variables are included in the review helpfulness model, including other important determinants. Results: The estimation results support the positive effect of review extremity and content on the helpfulness. In particular, the reviewer's skin type information was recognized as highly useful when presented together as a basis for high-rated reviews. Moreover, the content related to skin issues positively affects review helpfulness. Conclusions: The positive relationship between extreme reviews and helpfulness of reviews challenges the findings from prior literature. This result implies that an in-depth study of the effect of product types on review helpfulness is needed. Furthermore, a positive effect of review content on helpfulness suggests that applying big data analytics can provide meaningful customer insights in the online retail industry.

• Journal of Fashion Business
• /
• v.21 no.6
• /
• pp.77-86
• /
• 2017

This study aims to explore the unethical issues in leather processing and to develop designs of leather products based on the concept of reincarnation by ecosystem circulation. The method used in this research include the review of previous literature and the design process for development fashion accessories using waste leather. The design process comprises collecting waste leather, classifying waste leather by type, color, and size, and developing leather products according to line carnation method. For this research, the material was limited to waste cowhide leather collected from leather workshops and leather product factories. The leather pieces were divided into typical and atypical types and developed leather accessories based on the leather piece's color and size. A twill brooch, four-string bracelet, a brooch using the four-stringed leather strap and mini handbag designs were developed using regular type waste leather. An armband of abstract patterns and a cellphone case with graffiti pattern using irregular type over-splitting waste leather. The environmental issues in design are observed as part of understanding the significance of this study. Development of waste leather accessory can expand the usability of the waste leather as well as increase the product value by creating limited-line editions. By understanding the role and benefits of sustainable upcycling, this research suggests an efficient way to use waste materials in fashion to coexist with the natural environment.

• Korean Journal of Mathematics
• /
• v.27 no.1
• /
• pp.221-267
• /
• 2019

In the five first sections of this paper we define and study the hypergeometric transmutation operators $V^W_k$ and $^tV^W_k$ called also the trigonometric Dunkl intertwining operator and its dual corresponding to the Heckman-Opdam's theory on ${\mathbb{R}}^d$. By using these operators we define the hypergeometric translation operator ${\mathcal{T}}^W_x$, $x{\in}{\mathbb{R}}^d$, and its dual $^t{\mathcal{T}}^W_x$, $x{\in}{\mathbb{R}}^d$, we express them in terms of the hypergeometric Fourier transform ${\mathcal{H}}^W$, we give their properties and we deduce simple proofs of the Plancherel formula and the Plancherel theorem for the transform ${\mathcal{H}}^W$. We study also the hypergeometric convolution product on W-invariant $L^p_{\mathcal{A}k}$-spaces, and we obtain some interesting results. In the sixth section we consider a some root system of type $BC_d$ (see [17]) of whom the corresponding hypergeometric translation operator is a positive integral operator. By using this positivity we improve the results of the previous sections and we prove others more general results.

• The Journal of the Convergence on Culture Technology
• /
• v.8 no.3
• /
• pp.435-439
• /
• 2022

Many of the industry was changed because of the pandemic of covid 19. It combined with the tendency of modern people to pursue convenience. The industry of Cosmetics also changed business channel from offline to online. Before, people can not get suggestions after they complete the survey. This paper research how to suggest some cosmetics products with their skin type and skin data. We will develop Beauty Concierge system that can get suggestion after the survey. It's will make people attend activity and can make more benefit to the people.

• Proceedings of the Korean Institute of Building Construction Conference
• /
• 2022.04a
• /
• pp.17-18
• /
• 2022

Carbon dioxide emissions in the construction sector account for 38% of all industries, and environmental destruction is occurring due to indiscriminate use of natural resources. The purpose of this study is to develop by-product aggregate Non-Sintered Cement(NSC) that can replace sand used as natural aggregate and Portland cement. Therefore, Ground Granulated Blast Furnace Slag, Type C Fly Ash and Type F Fly Ash are used to replace cement, and water granulated ferro-nickel slag(FNS) is used to replace aggregate. The flow, compressive strength and flexural strength of the formulation using sand as an aggregate and the formulation replacing 100% FNS were compared. As a result of the experiment, the formulation using FNS had higher overall strength than the formulation using sand, and as the substitution rate of Type C fly ash increased, the strength was the best. Formulation using FNS is more fluid than using sand. Through this study, we show the possibility of 100% substitution of FNS and its applicability to secondary concrete products of by-product aggregate NSC.