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Statistical Considerations in the Design of Biosimilar Cancer Clinical Trials

  • Ahn, Chul;Lee, Seung-Chun
    • The Korean Journal of Applied Statistics
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    • v.24 no.3
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    • pp.495-503
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    • 2011
  • When a patent of an innovative (brand-name) small-molecule drug expires, generic copies of the innovative drug may be marketed if their therapeutic equivalence to the innovative drug has been shown. The small-molecule drugs are considered therapeutically equivalent and can be used interchangeably if two drugs are shown to be pharmaceutically equivalent with identical active substance and bioequivalent with comparable pharmacokinetics in a crossover clinical trial. However, the therapeutic equivalence paradigm cannot be applied to biosimilars since the active ingredients of biosimilars are huge molecules with complex and heterogeneous structures, and these molecules are difficult to replicate in every detail. The European Medicine Agency(EMEA) has introduced a regulatory biosimilar pathway which mandates clinical trials to show therapeutic equivalence. In this paper, we discuss statistical considerations in the design and analysis of biosimilar cancer clinical trials.

Marketing Mix and Performance of the Pharmaceutical Industry in Antiulcer Drugs (국내 병의원 시장에서의 소화성 궤양 치료제의 마케팅 요인 분석)

  • Ji, Hyon-Gyong;Kwon, Soon-Man
    • Korea Journal of Hospital Management
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    • v.5 no.1
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    • pp.24-39
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    • 2000
  • This paper aims to analyze the effects that marketing mix variables have on the marketing performance of pharmaceutical manufacturers. It examines how product characteristics, price, marketing channel and promotion effort influence the sales and market share of anti-ulcer drugs in the markets for clinics and hospitals separately. Empirical results from 29 products of anti-ulcer drugs show that sales in hospitals are affected by the profit per prescription to the physician, brand name drugs relative to generics, and the age of ingredients since its introduction to the markets. Profit per prescription to the hospital, relative price, age of ingredients and promotion effort have positive effects on the market share.

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Study of Consumer's Interest in Garment Label (Garment Label과 소비자관심에 관한 연구)

  • Lim Sook ja
    • Journal of the Korean Society of Clothing and Textiles
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    • v.2 no.2
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    • pp.227-235
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    • 1978
  • This study was designed to find out consumer's interest in garments label and to help home economists make interest for the further study in relation between producers and consumers as gap bridger. The questionnair method was used to obtained the data which was made by a result of self-administered questionnair. A size of random sample for this research was 364 subjects. The study found the following: (1) Most of consumers are relatively interested in garments label. The most concious age level was woman of fourty. (2) The most interest factor was label of size, price, fiber contents. brand name, directions and precautions on proper use and care. (3) The order of complaining item after washing was change of size, and color, seam pucker. deformation of collar. and button. (4) Most of consumers do not follow the direction when they clean their garments. (5) The respondents seem to be not understand the garment's informative label.

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카탈로그 쇼핑시 패션 라이프스타일과 위험지각과의 관계에 관한 연구

  • 전달영;정혜연
    • Journal of Distribution Research
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    • v.4 no.1
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    • pp.185-203
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    • 1999
  • This paper is an exploratory study about perceived risks related to career women's fashion lifestyles in case of catalogue shopping. Three research questions are proposed: 1. The first is to examine the types of career women's fashion lifestyles. 2. The second is to find out the kinds of perceived risks when career women purchase fashion apparels through catalogues. 3. The third is to investigate the relationships between fashion lifestyles and perceived risks. The empirical results were as follows. First, career women's fashion lifestyles were distinctively divided into the fashion-oriented group, the casual preference group, and the brand-name preference group. Second, seven unique perceived risks such as socio-psychological perceived risks, product assortment perceived risks, quality/function perceived risks, customer services & conveniences perceive risks, economic perceived risks, and order waiting-time perceived risks were manifested when career women purchase fashion apparels using catalogues. Finally, significant differences in socio-psychological perceived risks, product assortment perceived risks, and quality/function perceived risks were shown among fashion lifestyle clusters. However, the others were not.

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The Comparison Analysis Between Consumers and Dealers' Willingness to Purchase Environmentally Friendly Agricultural Products (친환경농산물에 대한 소비자와 유통업자의 구매의향 비교 분석)

  • Kim, Chung-Sil;Lee, Sang-Ho
    • Korean Journal of Organic Agriculture
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    • v.17 no.3
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    • pp.291-306
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    • 2009
  • The purpose of this study is to analyze the difference between the consumers' willingness to purchase environmentally friendly agricultural products and the distributers. The main results are as follows; First, it appeared with the fact that the reliability of the consumer against environmentally friendly agricultural products is 50% under. So it is important to fully guarantee the certification of environmentally friendly agricultural products. Second, if the traceability and brand-name system were introduced, the consumers and dealers would more likely to purchase environmentally friendly agricultural products more than they are now. Third, it shows a significant result in certification, developing packing-materials and sale and consuming magnification intention by the t-test between consumers and dealers.

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Export Positions in the Global Apparel Commodity Chain and Unit Values of Apparel and Textile Products Exported to the United States (국제의류사슬 내 수출위치가 섬유 및 의류제품의 미국 내 수출단가에 미치는 영향)

  • Lee, Eun-Ju;Lee, Kwang-Bae
    • Journal of the Korean Society of Clothing and Textiles
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    • v.26 no.12
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    • pp.1716-1726
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    • 2002
  • 본 연구는 국제의류사슬 내 수출위치를 단순조립 생산 (Mere-Assembly Production), 주문자 상표부착 생간방식 (Origin Equipment Manufacturing), 고유상표 생산방식 (Original Brand Name Manufacturing)으로 규명하고, 각 국가의 의류사슬 내 수출 위치가 수입 단가에 어떠한 영향을 미치는지 조사하였다. 1999년 미국Department of commerce의 무역 자료를 사용하여 국제 의류사슬 내 각각의 위치를 점하고 있는 방글라데시, 홍콩, 한국, 이태리를 비교한 결과, 의류사슬 내 위치에 따라 이들 국가로부터의 섬유 및 의류제품의 미국 내 수출단가가 통계 적으로 유의 한 차이를 보이는 것으로 나타났다.

A Study on Self-Image of the Eldery Women (노년(老年) 여성(女性)의 자아(自我)이미지에 관(關)한 연구(硏究))

  • Wee, Hye-Jung;Sohn, Hee-Soon
    • Journal of Fashion Business
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    • v.5 no.2
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    • pp.117-127
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    • 2001
  • This study identified self-image of the eldery wemen by relatied to body-satisfaction, self-image, shopping-orientatons. For study, a questionnaire was used a method of mearsurement and eldery women in seoul and kyunggi were selected as a sample. Data was processed by SPSS PC+ program and analyzed by using frequency, percentage, t-test, factor analysis and Pearson's correlation. As a result, the body-satisfaction of eldery women was very low, their pursuiting self-image was gracios, younger, noble. The self-image classified grace attraction factor, intelligence factor and activity factor. Relationship between body-satisfaction and self-images was significant to gracious attractive factor and active factor. The shopping-orientatons classified brand name disply factor, personality pride factor, pratical benefit factor, prudence factor, planning purchase factor. Shopping-orientatons and self-images were significant to Pearson's correlation. The aim of this study help fashion contractors and retailers to establish effective marketing strategies.

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Piracy of China's Trade Marks and Domain Names and Cultivation of its Famous Brands

  • Wang, Guo-an
    • International Commerce and Information Review
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    • v.6 no.2
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    • pp.3-12
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    • 2004
  • A large number of Chinese trade marks and domain names have been registered improperly or illegally by foreign companies or businessmen. Additionally, a large number of famous Chinese brands have vanished through joint ventures, mergers and acquisitions since foreign direct investment (FDI) came to China more than two decades ago because some Chinese managers have not been fully aware of the value of trade marks and domain names. Consequently, the number of China's registered trade marks and famous brands does not match China's export volume and its Number four trade status in the world. China's enterprises have yet to realize the effects of these events. It is very important for China to protect and cultivate its own famous brands. This paper discusses Chinese companies' neglect of the value of their trade marks and domain names, and the possible consequences. Additionally, this paper puts forward suggestions concerning the protection and cultivation of China's famous brands.

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A study on the Perfume Purchasing Behaviors and Fashion Leadership (유행선도력에 따른 향수 구매행동에 관한 연구)

  • 류은정;김경화;이경화
    • Journal of the Korean Home Economics Association
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    • v.38 no.12
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    • pp.101-110
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    • 2000
  • The purpose of this study were to investigate the influences of fashion leadership on consumers'evaluation of domestic and imported perfume product, and perfume purchasing behaviors and to find out the demographics and consumer value on fashion leadership. The data were collected from 369 female college students using questionnaire. The results were as follows: First, there were significant differences on consumers'evaluation of domestic and imported perfume product between the groups on fashion leadership. The higher the fashion leadership, the much positive consumers'evaluation of imported perfume product. Second, Fashion leaders'the frequency of perfume usage and the pieces of perfume product were higher than fashion followers. The most important perfume attribute of all groups was scent, and fashion leader took the much significant view of brand name than fashion followers. Third, Fashion leaders'economical level and pleasure oriented value was higher than fashion followers.

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Ecological support system for promoting youth culture in a new millenium age A study of Adolescents consumer conspicuous consumption - Comparisons between seoul city, small and medium-sized cities and towns - (새 밀레니엄에서의 청소년 문화창조를 위한 생태학적 지원체계(III): 청소년의 건전소비문화 정착을 위한 과시소비 기초 분석 -서울시, 중소도시, 군.읍.면 비교-)

  • 계선자;이정우;김명자;박미석;강기정
    • Journal of the Korean Home Economics Association
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    • v.38 no.12
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    • pp.15-28
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    • 2000
  • The purpose of this study is to analyze Adolescents spending habits and examine it. The data was collected from 1125 high school students and their parents nationwide. The resets are as follows. 1. About seventy eight percent of the responded students own relatively high-priced goods such as brand-name jeans (59.1%), a mobile phone (31.9%), perfume with a price of 50,000 won or more (26.5%), CD Player (24.4%) or electronic pocket diary (17.1%). The percentage varies according to region. 2. The Adolescents tendency for conspicuous consumption is reflected by 2.92 points out of a total 5 points, while their mothers'marks 2.18 points. By region, conspicuous consumption behavior is more common in Seoul than in other small and medium-sized cities and towns. Also, the more mother attribute children's behavior internally, the lower the childeren's competence is.

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