• 제목/요약/키워드: Pharmaceutical Industry

검색결과 453건 처리시간 0.027초

Non-clinical pharmacokinetic behavior of ginsenosides

  • Won, Hyo-Joong;Kim, Hyun Il;Park, Taejun;Kim, Hyeongmin;Jo, Kanghee;Jeon, Hyojin;Ha, Seo Jun;Hyun, Jung Min;Jeong, Aeri;Kim, Jung Sik;Park, Ye Jin;Eo, Yun Ho;Lee, Jaehwi
    • Journal of Ginseng Research
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    • 제43권3호
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    • pp.354-360
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    • 2019
  • Ginsenosides, the major active ingredients of ginseng and other plants of the genus Panax, have been used as natural medicines in the East for a long time; in addition, their popularity in the West has increased owing to their various beneficial pharmacological effects. There is therefore a wealth of literature regarding the pharmacological effects of ginsenosides. In contrast, there are few comprehensive studies that investigate their pharmacokinetic behaviors. This is because ginseng contains the complicated mixture of herbal materials as well as thousands of constituents with complex chemical properties, and ginsenosides undergo multiple biotransformation processes after administration. This is a significant issue as pharmacokinetic studies provide crucial data regarding the efficacy and safety of compounds. Moreover, there have been many difficulties in the development of the optimal dosage regimens of ginsenosides and the evaluation of their interactions with other drugs. Therefore, this review details the pharmacokinetic properties and profiles of ginsenosides determined in various animal models administered through different routes of administration. Such information is valuable for designing specialized delivery systems and determining optimal dosing strategies for ginsenosides.

Determinants of Sustainability Performance in Pharmaceutical Distribution Industry

  • KIM, Yong-Ha;KIM, Young-Taek
    • 유통과학연구
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    • 제18권12호
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    • pp.91-100
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    • 2020
  • Purpose: The objective of this study is to deepen our understanding of the key factors that determine sustainability in terms of suppliers based on the transactions between suppliers (pharmaceutical companies) and buyers (medical institutions) in the pharmaceutical distribution industry. Research design, data and methodology: Transaction justice factors were derived from three main components: distributive, procedural and interpersonal, five hypotheses were set up. The respondents from the data collected through an online survey are sales staff of pharmaceutical companies. Total of 319 questionnaires are collected and used to verify the hypotheses through the SPSS 22.0 and AMOS 22.0 programs. Results: Justice of transactions perceived by the salesperson of pharmaceutical companies was found to have a significant effect on the relationship commitment. Among them, procedural justice was found to have greatest relative influences. In addition, relationship commitment was found to have a significant effect on sustainability performance. Thus, all hypotheses were adopted. Conclusions: The results of this study, can be used as basic data for the guidelines for fair trade between pharmaceutical companies and medical institutions. In addition, it is expected that the study will have significance in that it examined sustainability through transactions with buyers from the viewpoint of suppliers.

Control of Uniformity in the Drug Industry By focusing on solid dosage forms for internal use

  • Lee, Seung-Woo
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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    • pp.40-41
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    • 2003
  • The present topic in pharmaceutical industry is to establish Quality Assurance System for medicinal product Therefore, the most important and urgent subject to be solved in the field of the manufacturing industry is to establish, implement and maintain the control system for ensuring uniformity of medicinal product. In case of solid dosage forms for internal use, its quality was controlled by disintegration test, etc but at present bioavailability could be predicted with dissolution test and so the assurance of its uniformity should be prerequistie to preserve suitable dissolution of the manufactured medicinal product. (omitted)

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의약품 설계 기반 품질 고도화(QbD)를 위한 QbD 6시그마 체계 구축에 관한 연구 (A Study on the Build of a QbD Six Sigma System to Promote Quality Improvement(QbD) Based on Drug Design)

  • 김강희;김현정
    • 품질경영학회지
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    • 제50권3호
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    • pp.373-386
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    • 2022
  • Purpose: This study proposes the application of Six Sigma management innovation method for more systematically enhanced execution of Quality by Design (QbD) activities. QbD requires a deeper understanding of the product and process at the design and development stage of the drug, and it is very important to ensure that no fault is fundamentally generated through thorough process control. Methods: Analyzing the background and specific procedures of quality improvement based on the drug design basis, and analyzing the key contents of each step, we have differentated and common points from the 6 Sigma methodology. We propose a new model of Six Sigma management innovation method suitable for pharmaceutical industry. Results: Regulatory agencies are demanding results from statistical analysis as a scientific basis in developing medicines to treat human life through quality improvement activities based on drug design. By utilizing the education system to improve the statistical analysis capacity in the Six Sigma activities and operating the 6 Sigma Belt system in conjunction, it helped systematically strengthen the execution power of quality improvement activities based on pharmaceutical design based on the members of the pharmaceutical industry. Conclusion: By using QbD Six Sigma, which combines quality enhancement based on pharmaceutical design basis and Six Sigma methodology suitable for pharmaceutical industry, it is possible to obtain satisfactory results both by pharmaceutical companies and regulators by using appropriate statistical analysis methods for preparing scientific evidence data required by regulatory.

A Strategy of Improved Formulation Development in Pharmaceutical Industry

  • Shin, Hee-Jong
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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    • pp.44-46
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    • 2003
  • Although Cyclosporin A (CsA) is a powerful immunosuppresant with little adverse effect on the bone marrow, CsA administered orally in the general formulation cannot obtain high bioavailability due to its poor aqueous solubility. To improve the solubility and enhance the bioavailability of poorly water-soluble CsA, many different approaches have been made in our laboratory. (omitted)

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Bootstrapped Malmquist 지수를 이용한 국내 의약품산업의 생산성 변화 요인 분석에 관한 연구 (An Analysis of the Productivity Changes of Korean Pharmaceutical Industry Using Bootstrapped Malmquist Index)

  • 소순후
    • 경영과정보연구
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    • 제35권4호
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    • pp.141-153
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    • 2016
  • 본 연구는 Bootstrapped Malmquist 지수를 이용하여 국내 의약품산업의 생산성 변화 추이를 측정하고 이러한 변화를 기술효율성 변화와 기술변화 요인으로 분해함으로써 의약품산업의 생산효율성을 제고하기 위한 시사점을 제시하고자 한다. 특히 기존의 연구들과 달리 투입 및 산출요소의 여분을 반영하여 투입최소화와 산출최대화를 측정할 수 있는 투입산출지향 비방사적 Malmquist 지수를 분석에 활용한다. 또한 평활부트스트랩 방법을 적용하여 Malmquist 지수와 그 구성요인의 통계적 신뢰구간을 추정한다. 실증분석을 위해 2005년에서 2014년까지 10개년의 균형패널자료를 수집하였으며, 분석에 사용된 투입요소는 종사자수, 유형자산, 주요생산비를 선정하였고, 생산액을 산출요소로 사용하였다. 분석 결과, 의약품산업의 생산성은 분석기간 동안 하락한 것으로 나타났으며, 이러한 생산성 하락은 기술진보의 둔화에 기인한 것으로 나타났다. 또한 의약품산업의 기술적 효율성은 순수효율성보다는 규모효율성에 보다 많은 영향을 받은 것으로 분석되었다. 따라서 향후 의약품산업의 경쟁력 강화를 위해서는 효율적 R&D 투자와 산업구조의 선진화를 통해 기술혁신역량을 강화하는 정책적 지원이 요구된다.

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How to Enhance International Competitiveness of Korean Pharmaceutical Industry with CEPA as a momentum?

  • Park, Hyun-Chae
    • 무역상무연구
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    • 제48권
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    • pp.101-125
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    • 2010
  • CEPA(Comprehensive Economic Partnership Agreement, hereinafter CEPA) between India and Korea may influence some changes on Korean pharmaceutical industry which shows less competitive advantages than Indian industry in many regards. So the purpose of this paper remains on suggesting the way of enhancing international competitiveness for Korean industry on the basis of double diamond model. Through the comprehensive and deep analysis, our findings on recommendable business strategies for Korea are as follows ; in terms of factor conditions, first, cooperative strategy in R&D for developing generics will be required. Second, Introduction of CMO business can be considered. In terms of demand condition, Korean firms should find out the chance for demand creation in Indian market which has future market potential and American market exploration, as soon as possible. With regards to strategy, structure and competition, trying M&A with leading Indian companies and utilizing well organized medical professionals in India will be considered. In the points of related and supportive parts, lastly, Korean government should try to make so called "National Strategic R&D committee" for pharmaceuticals and bring u-healthcare service to Korea in the first place. If Korean pharmaceutical industry implement above-mentioned strategies, CEPA can be turned into business opportunities from the crisis. As a result, Korean firms shall have more powerful global competitiveness eventually.

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Polymorphic Characterization of Pharmaceutical Solids, Donepezil Hydrochloride, by 13C CP/MAS Solid-State Nuclear Magnetic Resonance Spectroscopy

  • Park, Tae-Joon;Ko, Dong-Hyun;Kim, Young-Ju;Kim, Yon-Gae
    • Bulletin of the Korean Chemical Society
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    • 제30권9호
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    • pp.2007-2010
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    • 2009
  • Donepezil hydrochloride is a reversible acetylcholinesterase inhibitor that is used in the treatment of Alzheimer’s disease to improve the cognitive performance. It shows different crystalline forms including hydrates. Therefore, it is very important to confirm the polymorphic forms in the formulations of pharmaceutical materials because polymorphs of the same drug often exhibit significant differences in solubility, bioavailability, processability and physical/chemical stability. In this paper, four different forms of donepezil hydrochloride were prepared and characterized using X-ray powder diffraction, Fourier transform infrared, and solid-state nuclear magnetic resonance (NMR) spectroscopy. This study showed that solid-state NMR spectroscopy is a powerful technique for obtaining structural information and the polymorphology of pharmaceutical solids.

An Efficient and Stable Method for the Transformation of Heterogeneous Genes into Cephalosporium acremonium Mediated by Agrobacterium tumefaciens

  • XU WEI;ZHU CHUNBAO;ZHU BAOQUAN
    • Journal of Microbiology and Biotechnology
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    • 제15권4호
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    • pp.683-688
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    • 2005
  • A transformation system mediated by Agrobacterium tumefaciens is routinely used for the genetic engineering of plants. Here, we report an efficient and stable method for transformation of heterogeneous genes into an industrial Cephalosporium acremonium by using a similar transformation system established in plants. Both the phleomycin-resistant gene and vgb gene were used as screening markers to confirm the success of transformation by either Southern hybridization or PCR amplification. It was found that acetosyringone (AS) was necessary only for protoplast transformation and the heterogeneous genes transferred were integrated into the genome of C. acremonium. The transformation efficiency obtained with this system was much higher than the conventional techniques used for transformation of C. acremonium.

Review for Innovation and Patent System in the Pharmaceutical Sector

  • Minn, Mari
    • STI Policy Review
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    • 제8권1호
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    • pp.87-112
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    • 2017
  • This study analyzes patenting practices in the pharmaceutical industry and the impacts of sequential innovation. The main argument of the research is that strategic patenting is common in the pharmaceutical sector and it is legal within the context of patent law. However, when these practices have negative effects on the competition process post-grant, the practices that are legal under patent law may come into conflict with antitrust laws, which are not applied. The study brings into question whether sequential patenting practices characteristic of the pharmaceutical industry encourage or discourage innovation, and moreover, the overall functionality of the patent system. Ultimately, the functionality of the patent system creates market incentives that neglect consumer, i.e., patient, welfare; potential solutions to deal with the shortcomings are discussed.