• 제목/요약/키워드: Pharmaceutical Industry

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The Role of Transformational Leadership toward Work Performance through Intrinsic Motivation: A Study in the Pharmaceutical Field in Vietnam

  • NGUYEN, Ha Minh;MAI, Lam Tung;HUYNH, Tam Luong
    • The Journal of Asian Finance, Economics and Business
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    • 제6권4호
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    • pp.201-212
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    • 2019
  • The study aims to identify the role of transformational leadership toward work performance through intrinsic motivation in pharmaceutical field by a survey of 220 pharmacists in Vietnam. The pharmaceutical industry in Vietnam is experiencing rapid growth, accompanied by the need for a change in leadership for managers. The transformational leadership creates a proactive, positive attitude, passion, interest or an increase in intrinsic motivation of employees, thereby affecting work performance. This study performed reliable verification by Cronbach's Alpha coefficient, then the factors are analyzed by EFA before conducting multivariate regression analysis. The results showed that the transformational leadership style includes such factors as: idealized influence (attributed and behavior), inspirational motivation, intellectual stimulation, individualized consideration have a positive impact on intrinsic motivation and thereby positively affecting work performance. It confirms that employees will have a higher intrinsic motivation level when working under transformational leadership from their leaders. It makes employees work more efficiently. According to the research results, the pharmacist has an intrinsic motivation to work hard on tasks that contribute to the group overall goal of. That requires managers to have a task assignment strategy to connect the goals of the members together as well as of the members to the group.

Identification of Pharmaceuticals for process control using Near Infrared Spectroscopy and Soft Independence modeling of Class Analogy (SIMCA)

  • Cho, Chang-Hee;Kim, Hyo-Jin;Maeng, Dae-Young;Seo, Sang-Hun;Cho, Jung-Hwan
    • Near Infrared Analysis
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    • 제1권2호
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    • pp.29-33
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    • 2000
  • The identification step of raw drug materials is an indispensible procedure in the GMP manufacturing process within the pharmaceutical industry. However, wet chemistry methods for identification of drug materials, used by the various Pharmacopeia are time-consuming and expensive steps. In this paper, near-infrared spectroscopy (NIRS) has been developed for identifying eleven drug substances including calcium pantothenate, cefaclor, cefoperazone, cephradine, dextromethorphan, ehtambutol, nicotinamide, pyrozinamide, tramadol, vitamin C, and vitamin E. Also the aim of ths work is to consturct a new algorithm for calibration model using soft independence modeling of class analogy (SIMCA) with Malinowskis Indicator Function (IND), which is used for finding the number of principal components of each class of the SIMACA model. The use of NIR technique with pattern recognition to qualify raw materials can make it possible to monitor process in real time as well as to control all procedures in the pharmaceutical industry. As the result, the samples identified of 183 different batches from 11 different compounds were separated clearly by SIMCA with 2nd derivative spectra in the NIR region of 1100∼2400 nm.

의약품 관련 법규상 개념 정의의 시행연혁에 관한 소고 (A Study on the Changes in Legal Definition of Medicinal Products in the Relevant Laws and Regulations)

  • 엄석기
    • 대한예방한의학회지
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    • 제18권1호
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    • pp.23-41
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    • 2014
  • Objective : The purpose of this study was to lay the groundwork for understanding the details and scope of the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and new drugs from natural products that are present in the medical field and the medical industry. Possible solutions are proposed in the end. Method : I analyzed the changes in definition of medicinal products since 1945 that have been used in relevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New Drug Application and Investigational New Drug Application). Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceutical industry, such as the establishment of dualistic medical and pharmaceutical System and the introduction of the substance patent. Due to those changes, boundaries of Western medicinal products and health food expanded, while those of herbal medicine products relatively downscaled. Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs from Natural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceutical System.

Absorption Study of Genistein Using Solid Lipid Microparticles and Nanoparticles: Control of Oral Bioavailability by Particle Sizes

  • Kim, Jeong Tae;Barua, Sonia;Kim, Hyeongmin;Hong, Seong-Chul;Yoo, Seung-Yup;Jeon, Hyojin;Cho, Yeongjin;Gil, Sangwon;Oh, Kyungsoo;Lee, Jaehwi
    • Biomolecules & Therapeutics
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    • 제25권4호
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    • pp.452-459
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    • 2017
  • In this study, the effect of particle size of genistein-loaded solid lipid particulate systems on drug dissolution behavior and oral bioavailability was investigated. Genistein-loaded solid lipid microparticles and nanoparticles were prepared with glyceryl palmitostearate. Except for the particle size, other properties of genistein-loaded solid lipid microparticles and nanoparticles such as particle composition and drug loading efficiency and amount were similarly controlled to mainly evaluate the effect of different particle sizes of the solid lipid particulate systems on drug dissolution behavior and oral bioavailability. The results showed that genistein-loaded solid lipid microparticles and nanoparticles exhibited a considerably increased drug dissolution rate compared to that of genistein bulk powder and suspension. The microparticles gradually released genistein as a function of time while the nanoparticles exhibited a biphasic drug release pattern, showing an initial burst drug release, followed by a sustained release. The oral bioavailability of genistein loaded in solid lipid microparticles and nanoparticles in rats was also significantly enhanced compared to that in bulk powders and the suspension. However, the bioavailability from the microparticles increased more than that from the nanoparticles mainly because the rapid drug dissolution rate and rapid absorption of genistein because of the large surface area of the genistein-solid lipid nanoparticles cleared the drug to a greater extent than the genistein-solid lipid microparticles did. Therefore, the findings of this study suggest that controlling the particle size of solid-lipid particulate systems at a micro-scale would be a promising strategy to increase the oral bioavailability of genistein.

의약품 자료독점제도의 국가별 현황과 국내 제도의 발전방향 (Pharmaceutical Data Exclusivity - Comparative Study and Future Direction in Korea)

  • 박실비아
    • Journal of Pharmaceutical Investigation
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    • 제39권4호
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    • pp.299-307
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    • 2009
  • Data exclusivity is one of the most important intellectual property rights of pharmaceuticals. During data exclusivity period, third parties are prohibited from relying on the data which the original company has submitted to regulatory authority for drug application. I investigated data exclusivity systems for pharmaceuticals in the US, EU, Canada and Korea. New chemical entities were usually given the longest periods of data exclusivity compared to drugs with new indication or new formulation, although the protection periods varied by country. For new drugs to be entitled to a data exclusivity, strict conditions should be met. Data exclusivity has also been provided as an incentive to promote clinical investigation and drug development for pediatric population or orphan diseases. In Korea, data exclusivity was adopted in 1995 as an additive provision to "drug re-examination" which is to investigate post-marketing safety information of new drugs. It was introduced with few discussion on the purposes or effects of data exclusivity on pharmaceutical industry and pharmaceutical market in this country. I found that Korea's data exclusivity system falls short of considerations on valuing innovation of pharmaceutical research. It is necessary to improve data exclusivity system in order to promote innovative pharmaceutical development and to balance intellectual property rights protection and access to drugs in this country.

특허 정보를 이용한 기업의 급진적 혁신에 관한 실증연구 (An Empirical Study on the Relationship between Corporate and Radical Innovation based on Patent Information)

  • 전수연
    • 한국산학기술학회논문지
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    • 제21권10호
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    • pp.471-479
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    • 2020
  • 본 연구에서는 급진적 혁신을 수행하는 기업의 특징을 특허 데이터를 중심으로 살펴보았다. 1980년도부터 특허 정보는 기업의 성과를 측정하기 위한 중요한 지표로 활용되어 왔지만, 급진적 혁신을 대표하기는 어려웠다. 따라서 본 연구를 통하여 특허 집약 산업(Patent Active Industry)인 제약 산업에서 특허 정보가 급진적 혁신 지표로서 활용 될 수 있는지 알아보고자 하였다. 분석을 위해 약 10년간의 FDA 승인 데이터, 국외 기업의 특허 데이터를 활용하였으며 네트워크 중심성 분석(Centrality Analysis)과 비모수적 분석법인 윌콕슨 부호 순위 검정(Wilcoxon Signed Rank Test)을 실시하였다. 네트워크 분석 결과 급진적 혁신을 수행하는 기업의 경우 다른 기업들보다 대학 및 타 제약 기업과 협력 활동이 활발함을 시각적으로 확인 할 수 있었으며, 통계분석 결과 급진적 혁신을 수행하는 기업과 그렇지 않은 기업 간 연결 중심성(Degree Centrality)과 근접 중심성(Closeness Centrality)에 차이가 있음을 확인 할 수 있었다. 본 연구의 결과는 기업의 연구개발 전략 및 정책 수립에 활용 될 것을 기대하며, 향후에는 기업의 급진적 혁신에 영향을 미치는 요소가 무엇인지 정량 분석이 가능할 것이다.

The Impact of Responsible Accounting on Organizational Performance: A Case Study of Pharmaceutical Enterprises in Vietnam

  • NGUYEN, Thieu Manh
    • The Journal of Asian Finance, Economics and Business
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    • 제8권3호
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    • pp.1065-1071
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    • 2021
  • This study seeks to analyze the impact, and provides more empirical evidence on the effect, of the responsible accounting model combined with scorecards on the organizational performance of pharmaceutical companies. The research methodology uses questionnaires survey distributed to pharmaceutical companies. Quantitative research was done with SPSS 25 software. After excluding invalid questionnaires due to many blank boxes, 306 questionnaires could be used by the author. Research results show that seven elements of the responsible accounting model combined with the balance scorecard all positively affect the organizational performance of enterprises in the pharmaceutical industry including: (1) dividing organizational structure into centers of responsibility according to strategy; (2) assigning management to management according to vision; (3) allocating costs and revenue; (4) making budget estimates according to balanced scorecard (BSC); (5) evaluating estimates with reality by BSC; (6) making BSC analysis reports; and (7) rewarding based on BSC. Cost allocation and revenue are the factors that have the strongest impact on the organizational efficiency of pharmaceutical enterprises. Based on the research results, the author has proposed recommendations to improve the good application of the responsible accounting model combined with the balance scorecard, thereby contributing to improving the organizational efficiency of pharmaceutical enterprises.