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A Comparative Study of Statistical Methods for Population Bioequivalence in 2 X 2 Crossover Design (2 X 2 교차설계법에서 모집단 생물학적 동등성 검정 방법 비교)

  • Park Sang-Gue;Lim Nam-Kyoo;Lee Jae-Young;Kim Byung-Chun
    • The Korean Journal of Applied Statistics
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    • v.18 no.1
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    • pp.159-171
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    • 2005
  • The US Food and Drug Administration(FDA) recommends that population bioequivalence and individual bioequivalence would be assessed to address the prescribability and switchability between a brand-name drug and its new formulation or generic copy in its 2001 guidance document. The test for population bioequivalence in the latest FDA guidance is recommended in 2 x 4 crossover design, but it turns out to be very conservative. Recently Lee, Shao & Chow(2002), Chow, Shao & Wang(2003) and McNally, Iyer & Mathew(2002) proposed new statistical methods for assessing population bioequivalence between drugs to correct the biasness of current FDA method. Since 2 x 2 crossover experiment is most welcomed design in bioequivalence testing, we adopt their methods to 2 x 2 crossover designs and compare their methodologies with FDA one through the simulation study.

Physico-Chemical and Sensory Properties of Commercial Korean Traditional Soy Sauce of Mass-Produced vs. Small Scale Farm Produced in the Gyeonggi Area (한식 간장의 이화학 및 관능적 특성 - 대기업 시판 제품과 경기지역 소규모 농가 생산 제품의 비교 -)

  • Choi, Nam-Soon;Chung, Seo-Jin;Choi, Ji-Yeon;Kim, Hye-Won;Cho, Jung-Joo
    • 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.

RELATIONAL CONTRACTING: THE WAY FORWARD OR JUST A BRAND NAME?

  • Fiona Y.K. Cheung;Steve Rowlinson
    • International conference on construction engineering and project management
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    • 2005.10a
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    • pp.1013-1016
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    • 2005
  • Accounts of the development of a successful construction project often stress the importance of team relationship, project environment and senior management commitment. Numbers of studies carried out in the past decades indicate there needs to be a change of culture and attitude in the construction industry. In order for a turn around in the industry, relational contracting approaches have become more popular in recent years. However, not all relational contracting projects were successful. This paper details the fundamental principles of relational contracting. It further reports findings of a research currently taking place in Australia, how effective is relational contracting in practice. The problem addressed in this research is the implementation of relational contracting: • Throughout a range of projects • With a focus on client body staff The context within which the research was undertaken is: • Empowerment, regional development and promotion of a sustainable industry • The participating organisations have experience of partnering and alliancing • Success has been proven on large projects but performance is variable • Need has been identified to examine skill sets needed for successful partnering/alliancing The practical rationale behind this research is that: • Partnering and alliancing require a change of mind set - a culture change • The Client side must change along with contracting side • A fit is required between organisation structure and organisation culture Research Rationale: The rationale behind this project has been to conduct research within participating organisations, analyse, rationalise and generalise results and then move on to produce generic deliverables and "participating organisation specific" deliverables. This paper sets out the work so far, the links between the various elements and a plan for turning the research output into industry deliverables.

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An Empirical Study on Statistical Optimization Model for the Portfolio Construction of Sponsored Search Advertising(SSA) (키워드검색광고 포트폴리오 구성을 위한 통계적 최적화 모델에 대한 실증분석)

  • Yang, Hognkyu;Hong, Juneseok;Kim, Wooju
    • Journal of Intelligence and Information Systems
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    • v.25 no.2
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    • pp.167-194
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    • 2019
  • This research starts from the four basic concepts of incentive incompatibility, limited information, myopia and decision variable which are confronted when making decisions in keyword bidding. In order to make these concept concrete, four framework approaches are designed as follows; Strategic approach for the incentive incompatibility, Statistical approach for the limited information, Alternative optimization for myopia, and New model approach for decision variable. The purpose of this research is to propose the statistical optimization model in constructing the portfolio of Sponsored Search Advertising (SSA) in the Sponsor's perspective through empirical tests which can be used in portfolio decision making. Previous research up to date formulates the CTR estimation model using CPC, Rank, Impression, CVR, etc., individually or collectively as the independent variables. However, many of the variables are not controllable in keyword bidding. Only CPC and Rank can be used as decision variables in the bidding system. Classical SSA model is designed on the basic assumption that the CPC is the decision variable and CTR is the response variable. However, this classical model has so many huddles in the estimation of CTR. The main problem is the uncertainty between CPC and Rank. In keyword bid, CPC is continuously fluctuating even at the same Rank. This uncertainty usually raises questions about the credibility of CTR, along with the practical management problems. Sponsors make decisions in keyword bids under the limited information, and the strategic portfolio approach based on statistical models is necessary. In order to solve the problem in Classical SSA model, the New SSA model frame is designed on the basic assumption that Rank is the decision variable. Rank is proposed as the best decision variable in predicting the CTR in many papers. Further, most of the search engine platforms provide the options and algorithms to make it possible to bid with Rank. Sponsors can participate in the keyword bidding with Rank. Therefore, this paper tries to test the validity of this new SSA model and the applicability to construct the optimal portfolio in keyword bidding. Research process is as follows; In order to perform the optimization analysis in constructing the keyword portfolio under the New SSA model, this study proposes the criteria for categorizing the keywords, selects the representing keywords for each category, shows the non-linearity relationship, screens the scenarios for CTR and CPC estimation, selects the best fit model through Goodness-of-Fit (GOF) test, formulates the optimization models, confirms the Spillover effects, and suggests the modified optimization model reflecting Spillover and some strategic recommendations. Tests of Optimization models using these CTR/CPC estimation models are empirically performed with the objective functions of (1) maximizing CTR (CTR optimization model) and of (2) maximizing expected profit reflecting CVR (namely, CVR optimization model). Both of the CTR and CVR optimization test result show that the suggested SSA model confirms the significant improvements and this model is valid in constructing the keyword portfolio using the CTR/CPC estimation models suggested in this study. However, one critical problem is found in the CVR optimization model. Important keywords are excluded from the keyword portfolio due to the myopia of the immediate low profit at present. In order to solve this problem, Markov Chain analysis is carried out and the concept of Core Transit Keyword (CTK) and Expected Opportunity Profit (EOP) are introduced. The Revised CVR Optimization model is proposed and is tested and shows validity in constructing the portfolio. Strategic guidelines and insights are as follows; Brand keywords are usually dominant in almost every aspects of CTR, CVR, the expected profit, etc. Now, it is found that the Generic keywords are the CTK and have the spillover potentials which might increase consumers awareness and lead them to Brand keyword. That's why the Generic keyword should be focused in the keyword bidding. The contribution of the thesis is to propose the novel SSA model based on Rank as decision variable, to propose to manage the keyword portfolio by categories according to the characteristics of keywords, to propose the statistical modelling and managing based on the Rank in constructing the keyword portfolio, and to perform empirical tests and propose a new strategic guidelines to focus on the CTK and to propose the modified CVR optimization objective function reflecting the spillover effect in stead of the previous expected profit models.

Current View of Orphan Drug Usage in Tertiary Hospital and Rare Incurable Disease Hospital (상급종합병원과 희귀난치성질환 전문병원의 희귀의약품 사용현황)

  • Choi, Kyung Suk;Jeong, Young mi;Kim, Yu Jeong;Kim, Yoon Hee;Gu, Hyunmin;Lee, Byung Koo;Lee, Eunsook;Rhie, Sandy Jeong
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.2
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    • pp.121-127
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    • 2016
  • Objective: Until now, there is minimal number of research for overall domestic status of orphan drug use in Korea. The purpose of this study is to identify the list of orphan drugs available in Korea and to understand the status of orphan drug usage in tertiary Hospitals and rare incurable disease Hospital. Methods: We made domestic orphan drug lists based on available orphan drugs in Korea. Based on this lists, we conducted e-mail survey from August, 2014 to September, 2014 to identify domestic status of orphan drug usage including the availability and management of orphan drugs. Results: There are three hundred and eighteen orphan drugs (184 ingredients) registered in Ministry of Food and Drug Safety. Among the three hundred and eighteen orphan drugs, Two hundred and twenty-eight drugs (102 ingredients) were selected. Information on each item was collected and documented with generic and brand names, manufacturers, wholesalers, indications, FDA approval status and insurance coverage. Forty-three tertiary hospitals and thirty-two rare incurable hospitals responded to the survey questionnaire (57.3%). According to the survey result, the antineoplastics and immunomodulating agents group has the highest percentage (40%) usage in the hospital. Of fortythree tertiary hospitals, thirteen hospitals manage orphan drugs separately (30.2%). Based on the reply, most of the healthcare professionals commented the drug information related to efficacy and safety including medication counseling of orphan drugs is insufficient. Conclusion: Through this study we anticipate providing an understanding of orphan drug usage status in Korea. We found the limited resources to the information on orphan drugs and this information requires updating on a regular basis. This can be the basis for further studies about preparing drug information, educational resources for rare disease patients.

The Study on Identifying the Components of Community Pharmacy Externship Based on Korean Community Pharmacists' Consensus (약학교과과정의 개국약국실습 방향에 관한 연구)

  • Kim, Sung Hyun;Oh, Jung Mi
    • Korean Journal of Clinical Pharmacy
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    • v.9 no.2
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    • pp.109-118
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    • 1999
  • The need for and components of a contemporary community pharmacy externship for pharmacy students have not been clearly identified in Korea. Mail survey was performed among 20 college of pharmacy deans and 800 community pharmacists to analyze the current status and develop a consensus regarding major focus area and criteria of community pharmacy externship to be implemented under the separation of dispensary from medical practice in year 2000. Mail survey yielded $80\%\;and\;23.5\%$ response rate for pharmacy school deans and community pharmacists, respectively. Of the 16 pharmacy schools that responded 14 said they have externship program in hospital pharmacy, and only 8 pharmacy schools responded of having externship program for community pharmacy. However, these community pharmacy programs lacked criteria and standard guideline for the externship. The results of survey revealed that community pharmacy externship program for students should be organized and directed toward developing expert knowledge and skills in pharmacy practice activities, clinical services, communications, pharmacy management, and professionalism. Pharmacy practice components should include competencies and skills in computer application, prescription processing, dispensing, pharmaceutical compounding, Narcotics Control Law application, maintenance and provision of drug information, and laws and regulations. Clinical service components should include the ability to identify patient's drug-related problems, provide long-term patient care and appreciate drug therapy services. Communication skills should be taught to effectively express his/her professional opinion, deduce the needs of others, utilize appropriate techniques and media to communicate ideas and conduct a patient interview and to obtain patient drug history. Pharmacy management skills should be taught to be efficient in medical insurance and drug control process. It was found that professionalism, morality, pharmacy practice experience, ability to provide clinical services, collect and provide drug information and regality are important criteria of preceptors. Externship sites should possess the ability to stock various drugs, access and provide diverse pharmacy services and should have private patient counseling area. Most pharmacists agreed that top 200 drugs' generic and brand name, indications, dosage, side effects, and contraindication should be instructed during the externship. It was also found that student and preceptor should be evaluated for their performances during the externship. This information will be incorporated into teaming objectives for students and to develop Academic Extemship Program Guidelines.

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Recognition and attitude to functional division between physicians and pharmacists of practising physicians and pharmacists in Taegu city (대구시 개원의사와 개국약사의 의약분업에 대한 인식과 태도)

  • Lee, Moo-Sik;Yoon, Nung-Ki;Suh, Suk-Kwon;Park, Jae-Yong
    • Journal of Preventive Medicine and Public Health
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    • v.26 no.1 s.41
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    • pp.1-19
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    • 1993
  • Mail questionnaire was administrated to 370 practising physicians and 388 pharmacists in Taegu city selected by systematic sampling to examine utilization states and opinion of pharmacy under medical care insurance programme and the attitude to the functional division between physicians and pharmacists from April to May 1992. Regarding the opinion on the outcome of drug-store under medical insurance, 71.2 percent of practicing physician answered faliure but 13.4 percent of practicing pharmacists answered failure in contrast. Fifty percent of practicing physician asserted introducing functional division between physician and pharmacist while 66.9 percent of practicing pharmacist answered drug-store under medical insurance itself is sucessful programme. Average daily numbers of preparation of medicine was 32.2 case. Percentage of utilization of drug-store under medical issurance to average daily cases of preparing of medicine was 20 percent, percentage of utilization with physician's prescription was 0.7 percent. And 58.7 percent of practicing physician experienced outside the institute prescription. Regarding the opinion on the pros and cons of enforcing functional division between physician and pharmacist, 59.2 percent of practicing physician prefered pros and 17.7 percent cons, but 38 percent of practicing pharmacist prefered pros and 45.5 percent cons. And pharmacist knew better the content of functional division between physician and pharmacist than physician. As a reason for pros of enforcing functional division between physician and pharmacist, practicing physician emphasized to prevent misuse or abuse of medicine but practicing pharmacist emphasized to display physician and pharmacist's professional ability. And as an opinion on implementation style of functional division between physician and pharmacist in pros respondents, practicing physician favored mandatory enforcement (52.3%), while practicing pharmacist favored partial incomplete functional division (81.7%). As the method of prescription if functional division between physician and pharmacist will be enforced, both practicing physician and pharmacist prefered generic name (44.0%, 89%) mostly, but physician prefered brand name (35.3%) secondly. Regarding the reason for not implementing functional division between physician and pharmacist up to date, both physician and pharmacist answered problem of business right between physician and pharmacist, followed by lack of recognition, and interest of people and lack of the govermental willness. Regarding the opinion on prior decision of condition for enforcing functional division between physician and pharmacist, practicing physician and pharmacist named uneven distribution of medical facilities and drug-store between rural and urban, inequality of physician and pharmacist manpower and the problem of manpower demand and supply mostly, and practicing physician pointed out establishing attitude of acceptance on the part of pharmacist and practicing pharmacist favored establishing attitude of acceptance on the part of physician, which was different attitudes between physician and pharmacist. Following conclusion was reached ; 1. Current drug-store under medical insurance program yield insufficient outcome, so we should consider program conversion from drug-store under medical insurance program to functional division between physician and pharmacist. 2. There were problem of business right and conflicts between physician and pharmacist at enforcing functional division between physician and pharmacist, so the goverment should search for formulating plan to resolve the problem and have neutral willness for the protection of the national health.

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