• Title/Summary/Keyword: Pharmaceutical Industry

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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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    • v.43 no.3
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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
    • Journal of Distribution Science
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    • v.18 no.12
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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
    • Proceedings of the PSK Conference
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    • 2003.10a
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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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A Study on the Build of a QbD Six Sigma System to Promote Quality Improvement(QbD) Based on Drug Design (의약품 설계 기반 품질 고도화(QbD)를 위한 QbD 6시그마 체계 구축에 관한 연구)

  • Kim, Kang Hee;Kim, Hyun-jung
    • Journal of Korean Society for Quality Management
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    • v.50 no.3
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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
    • Proceedings of the PSK Conference
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    • 2003.10a
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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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An Analysis of the Productivity Changes of Korean Pharmaceutical Industry Using Bootstrapped Malmquist Index (Bootstrapped Malmquist 지수를 이용한 국내 의약품산업의 생산성 변화 요인 분석에 관한 연구)

  • So, Soon-Hu
    • Management & Information Systems Review
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    • v.35 no.4
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    • pp.141-153
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    • 2016
  • This study estimates the productivity change of pharmaceutical industry and decompose the change into technical efficiency change and technological change to explore ways to improve the productive efficiency. Unlike most previous studies, this study employs the non-radial and non-oriented slacks-based Malmquist productivity index which can deals directly with the input excesses and output shortfalls. In addition a smoothed bootstrap method is applied to estimate statistical confidence intervals for the Malmquist Index and its components. For the empirical analysis a balanced panel data set is constructed covering ten years over the period from 2005 to 2014. The input variables used in this study are number of workers, tangible assets and major production cost. The gross production is selected as a main output variable. The empirical results suggest that the productivity of pharmaceutical industry has decreased due mainly to decline in the technological progress rather than improvements in technical efficiency. An analysis result shows that the scale efficiency outweighs the pure efficiency in determining the technical efficiency of pharmaceutical industry. Therefore, in order to enhance the competitiveness of domestic pharmaceutical industry, it is important to continue supporting policies to promote the technology innovation capability through efficient R&D investment and industry reform strategy.

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

  • Park, Hyun-Chae
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • v.48
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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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    • v.30 no.9
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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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    • v.15 no.4
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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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    • v.8 no.1
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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.