• 한국임상약학회지
• /
• 제27권2호
• /
• pp.105-112
• /
• 2017

Background: Generic medications are approved on the basis of bioequivalence with brand medications in healthy volunteers rather than the target population, there remains a substantial uncertainty regarding their clinical effectiveness and safety. The object of this paper is to compare the clinical equivalence of generic statin drugs in patients. Methods: Literature published before September 2016, which is indexed in PubMed, EMBASE, RISS, comparing generic to brand products in statins. Outcomes included blood lipid level, proportion of days covered (adherence), hospitalization and mortality. Results: 511 citations were screened, of which 11 studies met eligibility criteria (6 randomized clinical trials, 5 observational studies). Generic atorvastatin was clinical equivalent with brand drugs in blood lipid level (3 RCTs) and generic simvastatin was also clinical equivalent with brand drugs (2 RCTs). 2 of 3 studies reported no significant difference in proportion of days covered except 1 study which reported generic statin significantly enhance proportion of days covered (p<0.001). Hospitalization was no significant difference in all studies (p>0.05). 1 study reported that all cause of mortality was significantly low in generic drugs (p<0.0001). Conclusion: Published data on comparing clinical efficacy of generic and brand statins were insufficient in both quantity and quality. This systematic review suggests that additional studies on clinical equivalence and safety of generic medications in patients would be needed.

• Communications for Statistical Applications and Methods
• /
• 제13권2호
• /
• pp.285-295
• /
• 2006

As more generic drugs become available, the quality, safety, and efficacy of generic drugs have become a public concern. Specifically, drug interchangeability among generic copies of the same brand-name drug is a safety concern. This research proposes a Bayesian method for assessing bioequivalence between two generic copies of the same brand-name drug from two independent $2{\times}2$ crossover design experiments. Uninformative priors are considered for general use and the posterior distribution of the difference of two generic drug effects is derived from which the highest probability density interval can be evaluated. Examples are presented for illustration.

• 한국산학기술학회논문지
• /
• 제16권3호
• /
• pp.1806-1814
• /
• 2015

유통업체에서 PB(Private Brand)의 선택확률을 높이기 위하여 기존 PB보다 열등한 다른 PB를 사용하는 전략은 비용적인 측면에서 어려운 문제가 있다. 따라서 본 연구는 이를 해결하고자 2개의 현실적인 실험방법을 통해 PB의 유인 및 타협효과를 검증하고자 한다. 검증결과를 살펴보면 제조업체 브랜드(NB; National Brand)와 PB에 새로운 브랜드인 무상표(GB :Generic Brand)를 추가한 경우 유인 및 타협 효과가 발생하여 PB의 선택확률이 높아짐을 발견하였다. 구체적으로 실험 1에서는 NB와 PB의 특성상 경쟁대안과 표적대안의 선호도와 선택확률의 차이가 많은 경우에도 유인브랜드 진입 시 표적대안인 PB의 선택확률 변화를 확인하였다. 실험2에서는 경쟁사 PB를 열등한 대안에 위치시킬 때도 유인효과가 발생하여 자사 PB의 선택확률이 증가한다는 것을 확인하였다. 이러한 연구결과에 대한 전략적 시사점과 연구의 한계 및 향후 방향을 제시하였다.

• 약학회지
• /
• 제55권3호
• /
• pp.195-202
• /
• 2011

Generic medication market has been increased for economic reasons in Korea. Health authorities worldwide recommend the use of generic medications nowadays. However, patients in Korea are not familiar with the generic medications and considerable percent of those do not know the definition of the generic medications. The purpose of this study was to evaluate adults' knowledge and perception on the generic medications at community pharmacies in Korea. This study was a 11-questionnaire survey conducted from August 9, 2010 to August 27, 2010. Of the 204 respondents, 63 (30.9%) responded that they knew what a generic medication was, but only 16 (25.4%) of those answered that generic medications had the same efficacy as brand medications. When pharmacists were the source of generic medication information, more patients reported having knowledge about the definition of generic medications correctly compared with other sources. Patients with negative experience with generic medications within 6 months were more reluctant to generic substitution suggested by a pharmacist than those with positive experience. Based on the results of this study, further studies should be conducted to establish the best way to provide generic medication information for patients.

• 산경연구논집
• /
• 제5권2호
• /
• pp.21-28
• /
• 2014

Purpose - This study aims to understand the brand marketing of agricultural products and redefine their status in South Korea by analyzing impacts on consumer buying behaviors. Research design, data, and methodology - Products, with independent variables, were divided into agricultural brand products and generic products. Dependent variables were limited to expanding sales of a specialty brand through consumer awareness, consumer buying behavior, and confidence in agricultural products' quality. Control variables were based on characteristics of products such as freshness, safety, quality, and their category. Moderating effects were examined on consumer characteristics, including income levels and age. Results - Consumers increasingly purchased agricultural brand products rather than generic agricultural products because of the general reliability of quality assurance. Conclusions - Large agricultural specialty stores have enhanced the perceptions of quality assurance, freshness, safety, and diversity. Through a critical analysis of the domestic consumer income levels and age, gender, and demographic factors, such as agricultural consumer buying behavior not affecting consumers' health and life, this study proposes positive changes in quality perception.

• 대한약학회:학술대회논문집
• /
• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
• /
• pp.91-92
• /
• 2003

Virtually every state in US has adopted laws and regulations that mandate the generic substitution of brand-named prescription drugs in order to reduce sky-rocketing drug costs. In the late 1970s, many state governments began to recognize the need of generic substitution and requested Food and Drug Administration (FDA) to consult with this issue. FDA did consult which drugs were interchangeable each other based upon the available scientific and experimental evidences given to the agency along with New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). (omitted)

• 약학회지
• /
• 제49권4호
• /
• pp.255-259
• /
• 2005

Financial standing of National Health Insurance has been experiencing a grave deterioration during the last 4-5 years, and the yearly amount paid by the insurance for drug expense rose up to 4 trillion won recently. Furthermore, the ratio of drug expenses in the total expenditure of the insurance reached about $25\%$, showing the tendency to be levelled off. As a measure to improve the financial deterioration of the insurance and to encourage generic substitution among the health professionals, we compared pharmacokinetic parameters of brand name drug (Lamisil) and generic drug (Muzonal) containing terbinafine HCl in healthy volunteers. The area under the curve (AUC) of the two drugs showed $2220.4\pm784.7\;and\;2143.1\pm861.6hr{\cdot}ng/ml$ in the corresponding order and no statistically significant difference was identified. The peak concentration $(C_{max})$ of the generic drug demonstrated $566.6\pm246.2 ng/ml$ compared to $550.8\pm204.0$ of brand name drug, which was not significantly different either. Time to reach peak concentration showed about 6 minutes difference between the drugs, which has no clinical significance to the treatment of dermatomycosis and dermatophytosis.

• 한국임상약학회지
• /
• 제16권2호
• /
• pp.96-100
• /
• 2006

Korea Food and Drug Administration (KFDA) has been expediting the Biological Equivalence Examination (BEE) project to encourage generic substitution without expense of inappropriate therapeutic outcome. However, little is known about which considerations are most important in making the decision to prescribe a drug among many generic drugs. The purpose of this survey was to identify how strongly the KFDA certification of BEE influenced doctors when they make a choice between brand and generics of glimepiride preparations. Telephone survey was performed towards doctors working at local clinics by using a questionnaire. Most influential factor to doctors' decision was drug cost followed by pharmaceutical representatives, therapeutic efficacy, and review guideline for reimbursement. Advertisement of the drug was the least influential followed by KFDA certification of BEE. The meaning of BEE was best understood by relatively young doctors with specialty in surgical parts. This survey result further indicated that the doctors considered the therapeutic equivalence examination a preferred measure to expedite generic substitution.

• 농업과학연구
• /
• 제16권1호
• /
• pp.71-83
• /
• 1989

The purpose of this research are to forecast the demand and supply of milk in Korea, and to obtain information for attitudes affecting milk consumption, which is necessary to make a plan for increasing milk consumption in Korea. The estimation of the milk demand and production was made by the multiplicative decomposition method and the statistical function. Data on consumer were collected from 737 students who were attending primary school, middle school and university in Daejeon during the period of July 11 to July 21, 1988. The results obtained are as follows; 1. The prediction results showed that the production for milk will over supply 21,900 tons in 1,990, 70,800 tons in 1,995 by the multiplicative decomposition method and 45,400 tons in 1990, -51,500 tons in 1995 by the statistical function. 2. It was found that almost all the students awared milk as essential food-stuff of common food stuff for the Koreans. 3. Quite a few students were apt to believe that milk processors added water into fluid milk. 4. Most students showed obtaining information about the nutritional value of milk by school education and advertising of TV, Radio, and Printed media. 5. However, it was found that the advertising by TV, Radio, and Printed media did hardly give to consumers influences on the choice of a particular milk brand. Accordingly, the conclusions are as follows; 1. Need to provide consumers with well planned education programs on the nutritional value of milk. 2. Heavy brand advertising for fluid milk may mislead the understanding of consumer, since city milk is not much differentiated in Korea. Therefore the milk processors should put more efforts in generic milk promotion by reducing brand advertizement. 3. The milk processors should provide major portion of financing for generic milk promotion program.

• 패션비즈니스
• /
• 제10권3호
• /
• pp.87-99
• /
• 2006

For comprehending the duties of fashion designer, Sharon(1989) has suggested to look at the procedure how the goods are being produced. The purpose of this research is to identify the task of domestic fashion designer by comparing and analyzing one's work range and performing level in the fashion merchandising process according to the brand types which one is involved in. The preliminary research for the questionnaire was conducted with 5 chief designers of woman's apparel manufactures in Seoul. They were asked to judge if designer's tasks fit to their carry-out operations in the pre-fixed questionnaire which had been done based on preliminary researches and literatures related with fashion merchandising process. The contents of research questionnaire are 11 questions to understand the general characteristics of companies and the participated subjects, and 42 questions to understand the designers' operations. For the selection of NB, among 503 domestic female apparel brands that were in 'Korean Textile Fashion yearbook (2002-2003), the companies that were located in Seoul and possible for cooperation by researcher's personal relationship were selected. For DB, cooperation was requested for brands that were located in Seoul among the 137 brands that participates on Domestic Collection. For GB, 50 stores were selected at random or by personal relationship among 32 GB shops such as Freya Town, Doosan Tower, New Zone, and so on. Total 300 questionnaire distributed to the designers, 192 copies were used for final data analysis. For data analysis, descriptive statistics and ANOVA, Sceffe test were used using SPSS V. 11 1. The participated fashion designers operated 41 categories of suggested 42 categories in the fashion merchandising process. 2. The ranges and contents of tasks in the fashion merchandising process that fashion designers mainly carry-out are very different according to the brand types and showed much different level of task carry-out. Only in the categories of 'fashion trend information' and 'design ideation', all three brand type showed the highest level of task performance. And the design related tasks presented common higher level of performance than the other tasks in all brand types. In order to comprehend the operation of fashion designer, various approaching methods are required according to various apparel manufactures' characteristics.