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Sample records for industry q10 pharmaceutical

  1. International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice.

    Science.gov (United States)

    2009-04-08

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q10 Pharmaceutical Quality System." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH guidances on "Q8 Pharmaceutical Development" and "Q9 Quality Risk Management."

  2. 76 FR 57746 - Conference on the International Conference on Harmonisation Q10 Pharmaceutical Quality System: A...

    Science.gov (United States)

    2011-09-16

    ...] Conference on the International Conference on Harmonisation Q10 Pharmaceutical Quality System: A Practical Approach to Effective Life- Cycle Implementation of Systems and Processes for Pharmaceutical Manufacturing... ``Pharmaceutical Quality System (ICH Q10) Conference: A Practical Approach to Effective Life- Cycle Implementation...

  3. Enabling ICH Q10 Implementation--Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9.

    Science.gov (United States)

    Calnan, Nuala; O'Donnell, Kevin; Greene, Anne

    2013-01-01

    This article is the first in a series of articles that will focus on understanding the implementation essentials necessary to deliver operational excellence through a International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q10-based pharmaceutical quality system (PQS). The authors examine why, despite the fact that the ICH Q10 guideline has been with us since 2008, the transformation of the traditional Quality Management Systems QMS in use within the pharmaceutical industry is a work in progress for only a few forward-thinking organisations. Unfortunately, this transformation remains a mere aspiration for the majority of organisations. We explore the apparent lack of progress by the pharmaceutical sector in adopting six sigma and related quality management techniques to ensure the availability of high-quality medicines worldwide. The authors propose that the desired progress can be delivered through two key shifts in our current practices; by embodying the principles of operational excellence in every aspect of our business and by learning how to unlock the scientific and tacit knowledge within our organisations. It has been ten years since The Wall Street Journal revealed the pharmaceutical industry's "little secret" comparing the perceived level of manufacturing expertise in the industry as lagging far behind those of potato-chip and laundry-soap makers. Would you consider the quality and manufacturing strategies in place today in your organisation to be more efficient and scientifically based than those of 2003? If so, what evidence exists for you to draw any conclusion regarding enhanced performance? Do your current practices drive innovation and facilitate continual improvement and if so, how? Ultimately, can you confidently affirm that patient-related risks associated with the product(s) manufactured by your organisation have been reduced due to the quality assurance program now applied

  4. Comparative analysis of pharmaceuticals versus industrial chemicals acute aquatic toxicity classification according to the United Nations classification system for chemicals. Assessment of the (Q)SAR predictability of pharmaceuticals acute aquatic toxicity and their predominant acute toxic mode-of-action

    DEFF Research Database (Denmark)

    Sanderson, Hans; Thomsen, Marianne

    2009-01-01

    data. Pharmaceuticals were found to be more frequent than industrial chemicals in GHS category III. Acute toxicity was predictable (>92%) using a generic (Q)SAR ((Quantitative) Structure Activity Relationship) suggesting a narcotic MOA. Analysis of model prediction error suggests that 68...... a comprehensive database based on OECD's standardized measured ecotoxicological data and to evaluate if there is generally cause of greater concern with regards to pharmaceutical aquatic toxicological profiles relative to industrial chemicals. Comparisons were based upon aquatic ecotoxicity classification under...... the United Nations Global Harmonized System for classification and labeling of chemicals (GHS). Moreover, we statistically explored whether the predominant mode-of-action (MOA) for pharmaceuticals is narcosis. We found 275 pharmaceuticals with 569 acute aquatic effect data; 23 pharmaceuticals had chronic...

  5. Coenzyme Q10 production in plants: current status and future prospects.

    Science.gov (United States)

    Parmar, Sanjay Singh; Jaiwal, Anjali; Dhankher, Om Parkash; Jaiwal, Pawan K

    2015-06-01

    Coenzyme Q10 (CoQ10) or Ubiquinone10 (UQ10), an isoprenylated benzoquinone, is well-known for its role as an electron carrier in aerobic respiration. It is a sole representative of lipid soluble antioxidant that is synthesized in our body. In recent years, it has been found to be associated with a range of patho-physiological conditions and its oral administration has also reported to be of therapeutic value in a wide spectrum of chronic diseases. Additionally, as an antioxidant, it has been widely used as an ingredient in dietary supplements, neutraceuticals, and functional foods as well as in anti-aging creams. Since its limited dietary uptake and decrease in its endogenous synthesis in the body with age and under various diseases states warrants its adequate supply from an external source. To meet its growing demand for pharmaceutical, cosmetic and food industries, there is a great interest in the commercial production of CoQ10. Various synthetic and fermentation of microbial natural producers and their mutated strains have been developed for its commercial production. Although, microbial production is the major industrial source of CoQ10 but due to low yield and high production cost, other cost-effective and alternative sources need to be explored. Plants, being photosynthetic, producing high biomass and the engineering of pathways for producing CoQ10 directly in food crops will eliminate the additional step for purification and thus could be used as an ideal and cost-effective alternative to chemical synthesis and microbial production of CoQ10. A better understanding of CoQ10 biosynthetic enzymes and their regulation in model systems like E. coli and yeast has led to the use of metabolic engineering to enhance CoQ10 production not only in microbes but also in plants. The plant-based CoQ10 production has emerged as a cost-effective and environment-friendly approach capable of supplying CoQ10 in ample amounts. The current strategies, progress and constraints of

  6. Comparative analysis of pharmaceuticals versus industrial chemicals acute aquatic toxicity classification according to the United Nations classification system for chemicals. Assessment of the (Q)SAR predictability of pharmaceuticals acute aquatic toxicity and their predominant acute toxic mode-of-action

    DEFF Research Database (Denmark)

    Sanderson, Hans; Thomsen, Marianne

    2009-01-01

    data. Pharmaceuticals were found to be more frequent than industrial chemicals in GHS category III. Acute toxicity was predictable (>92%) using a generic (Q)SAR ((Quantitative) Structure Activity Relationship) suggesting a narcotic MOA. Analysis of model prediction error suggests that 68...

  7. Comparative analysis of pharmaceuticals versus industrial chemicals acute aquatic toxicity classification according to the United Nations classification system for chemicals. Assessment of the (Q)SAR predictability of pharmaceuticals acute aquatic toxicity and their predominant acute toxic mode-of-action.

    Science.gov (United States)

    Sanderson, Hans; Thomsen, Marianne

    2009-06-01

    Pharmaceuticals have been reported to be ubiquitously present in surface waters prompting concerns of effects of these bioactive substances. Meanwhile, there is a general scarcity of publicly available ecotoxicological data concerning pharmaceuticals. The aim of this paper was to compile a comprehensive database based on OECD's standardized measured ecotoxicological data and to evaluate if there is generally cause of greater concern with regards to pharmaceutical aquatic toxicological profiles relative to industrial chemicals. Comparisons were based upon aquatic ecotoxicity classification under the United Nations Global Harmonized System for classification and labeling of chemicals (GHS). Moreover, we statistically explored whether the predominant mode-of-action (MOA) for pharmaceuticals is narcosis. We found 275 pharmaceuticals with 569 acute aquatic effect data; 23 pharmaceuticals had chronic data. Pharmaceuticals were found to be more frequent than industrial chemicals in GHS category III. Acute toxicity was predictable (>92%) using a generic (Q)SAR ((Quantitative) Structure Activity Relationship) suggesting a narcotic MOA. Analysis of model prediction error suggests that 68% of the pharmaceuticals have a non-specific MOA. Additionally, the acute-to-chronic ratio (ACR) for 70% of the analyzed pharmaceuticals was below 25 further suggesting a non-specific MOA. Sub-lethal receptor-mediated effects may however have a more specific MOA.

  8. The Pharmaceutical Industry Beamline of Pharmaceutical Consortium for Protein Structure Analysis

    International Nuclear Information System (INIS)

    Nishijima, Kazumi; Katsuya, Yoshio

    2002-01-01

    The Pharmaceutical Industry Beamline was constructed by the Pharmaceutical Consortium for Protein Structure Analysis which was established in April 2001. The consortium is composed of 22 pharmaceutical companies affiliating with the Japan Pharmaceutical Manufacturers Association. The beamline is the first exclusive on that is owned by pharmaceutical enterprises at SPring-8. The specification and equipments of the Pharmaceutical Industry Beamline is almost same as that of RIKEN Structural Genomics Beamline I and II. (author)

  9. Doctors and pharmaceutical industry.

    Science.gov (United States)

    Beran, Roy G

    2009-09-01

    The pharmaceutical industry is seen as seducing doctors by providing expensive gifts, subsidising travel and underwriting practice expenses in return for those doctors prescribing products that otherwise they would not use. This paints doctors in a very negative light; suggests doctors are available to the highest bidder; implies doctors do not adequately act as independent agents; and that doctors are driven more by self-interest than by patient needs. Similar practices, in other industries, are accepted as normal business behaviour but it is automatically assumed to be improper if the pharmaceutical industry supports doctors. Should the pharmaceutical industry withdraw educational grants then there would be: fewer scientific meetings; reduced attendance at conferences; limited post graduate education; and a depreciated level of maintenance of professional standards. To suggest that doctors prescribe inappropriately in return for largesse maligns their integrity but where there is no scientific reason to choose between different treatments then there can be little argument against selecting the product manufactured by a company that has invested in the doctor and the question arises as to whether this represents bad medicine? This paper will examine what constitutes non-professional conduct in response to inducements by the pharmaceutical industry. It will review: conflict of interest; relationships between doctors and pharma and the consequences for patients; and the need for critical appraisal before automatically decrying this relationship while accepting that there remain those who do not practice ethical medicine.

  10. [The pharmaceutical industry in the industrial chemical group: the National Union of Chemical-Pharmaceutical Laboratories (1919-1936)].

    Science.gov (United States)

    Nozal, Raúl Rodríquez

    2011-01-01

    The pharmaceutical industry associations, as it happened with other businesses, had a significant rise during the dictatorship of Primo de Rivera and II Republic. The 'Cámara Nacional de Industrias Químicas', in Barcelona, represented the national chemical industry to its ultimate assimilation by the 'Organización Sindical' in 1939. In this association, matters relating to pharmaceutical products -- which we will especially deal with in this work -- were managed by the 'Unión Nacional de Laboratorios Químico-Farmacéuticos', which defended the interests of pharmaceutical companies in the presence of government authorities, using the resources and mechanisms also managed by business pressure groups. The inclusion of industrial pharmacy in the Chemical lobby separated the pharmaceutical industry from traditional exercise and its corporate environment. this created ups and downs, conflicts of interests and finally, love and hate relationships with their colleagues of the pharmacy work placement and, of course, with the association that represented them: the 'Unión Farmacéutica Nacional'.

  11. A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran.

    Science.gov (United States)

    Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Ebadifard Azar, Farbod; Nabilo, Bahram; Abolghasem Gorji, Hassan; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh

    2015-04-23

    Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world's greatest businesses. The aim of this study was to analyze Iran's comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran's trade in this field. To identify Iran's comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran's intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran's Customs Administration, Iran's pharmaceutical Statistics, World Bank and International Trade Center. The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world's total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran's pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran's intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade.

  12. Financial risk of the biotech industry versus the pharmaceutical industry.

    Science.gov (United States)

    Golec, Joseph; Vernon, John A

    2009-01-01

    The biotech industry now accounts for a substantial and growing proportion of total R&D spending on new medicines. However, compared with the pharmaceutical industry, the biotech industry is financially fragile. This article illustrates the financial fragility of the biotech and pharmaceutical industries in the US and the implications of this fragility for the effects that government regulation could have on biotech firms. Graphical analysis and statistical tests were used to show how the biotech industry differs from the pharmaceutical industry. The two industries' characteristics were measured and compared, along with various measures of firms' financial risk and sensitivity to government regulation. Data from firms' financial statements provided accounting-based measures and firms' stock returns applied to a multifactor asset pricing model provided financial market measures. The biotech industry was by far the most research-intensive industry in the US, averaging 38% R&D intensity (ratio of R&D spending to total firm assets) over the past 25 years, compared with an average of 25% for the pharmaceutical industry and 3% for all other industries. Biotech firms exhibited lower and more volatile profits and higher market-related and size-related risk, and they suffered more negative stock returns in response to threatened government price regulation. Biotech firms' financial risks increase their costs of capital and make them more sensitive to government regulations that affect their financial prospects. As biotech products grow to represent a larger share of new medicines, general stock market conditions and government regulations could have a greater impact on the level of innovation of new medicines.

  13. Q2/Q3 2017 Solar Industry Update

    Energy Technology Data Exchange (ETDEWEB)

    Feldman, David J. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Hoskins, Jack [Dept. of Energy (DOE), Washington DC (United States); Margolis, Robert M. [National Renewable Energy Lab. (NREL), Golden, CO (United States)

    2017-10-24

    This technical presentation provides an update on the major trends that occurred in the solar industry in Q2 and Q3 of 2017. Major topics of focus include global and U.S. supply and demand, module and system price, investment trends and business models, and updates on U.S. government programs supporting the solar industry.

  14. Q2/Q3 2016 Solar Industry Update

    Energy Technology Data Exchange (ETDEWEB)

    Feldman, David; Boff, Daniel; Margolis, Robert

    2016-10-11

    This technical presentation provides an update on the major trends that occurred in the solar industry in the Q2 and Q3 of 2016. Major topics of focus include global and U.S. supply and demand, module and system price, investment trends and business models, and updates on U.S. government programs supporting the solar industry.

  15. Q3/Q4 2016 Solar Industry Update

    Energy Technology Data Exchange (ETDEWEB)

    Feldman, David; Boff, Daniel; Margolis, Robert

    2016-12-21

    This technical presentation provides an update on the major trends that occurred in the solar industry in the Q3 and Q4 of 2016. Major topics of focus include global and U.S. supply and demand, module and system price, investment trends and business models, and updates on U.S. government programs supporting the solar industry.

  16. Q3/Q4 2017 Solar Industry Update

    Energy Technology Data Exchange (ETDEWEB)

    Feldman, David J. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Hoskins, Jack [Dept. of Energy (DOE), Washington DC (United States); Margolis, Robert M. [National Renewable Energy Lab. (NREL), Golden, CO (United States)

    2018-02-15

    This technical presentation provides an update on the major trends that occurred in the solar industry in the Q3 and Q4 of 2017. Major topics of focus include global and U.S. supply and demand, module and system price, investment trends and business models, and updates on U.S. government programs supporting the solar industry.

  17. A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran

    Science.gov (United States)

    Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Azar, Farbod Ebadifard; Nabilo, Bahram; Gorji, Hassan Abolghasem; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh

    2015-01-01

    Background: Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world’s greatest businesses. The aim of this study was to analyze Iran’s comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran’s trade in this field. Methods: To identify Iran’s comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran’s intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran’s Customs Administration, Iran’s pharmaceutical Statistics, World Bank and International Trade Center. Results: The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world’s total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran’s pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran’s intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. Conclusions: The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade. PMID:26153184

  18. Coenzyme Q 10: multiple benefits in one ingredient

    Directory of Open Access Journals (Sweden)

    Littarru Gian Paolo

    2011-03-01

    Full Text Available Coenzyme Q is a lipid molecule widely diffused in nature; in humans and other mammals it is present as coenzyme Q10. (CoQ10. The first recognized role of CoQ10 was in mitochondrial bioenergetics, where it plays a central role in the production of ATP. It is also present in other subcellular organelles, both in its oxidized and in its reduced state (ubiquinol-10. The reduced form of CoQ10 is endowed with powerful antioxidant activity: it acts as a chain-breaking antioxidant and is also capable of egenerating alpha-tocopherol, the active form of vitamin E. By these mechanisms CoQ10, together with vitamin E, protects lipoproteins from oxidation a process which bears considerable interest in preventing atherosclerosis. CoQ10 has also been found to support cardiovascular function and the latest findings indicate an active role in counteracting endothelial dysfunction, which is closely implicated in cardiovascular disease. CoQ10 also improves sperm motility, an effect which might be related both to its antioxidant and to its bioenergetic properties. Oxidative stress might be involved in neurodegenerative disease, and in migraine, two fields where the positive effects of CoQ10 have been documented. CoQ10 is synthesized by our body but is also present in food and can be taken as a nutritional supplement. The main source of industrially produced CoQ10 is yeast fermentation. The process results in CoQ10 which is identical to the naturally occurring molecule. Ubiquinol, the reduced form of CoQ10, has recently become available.

  19. Determinants of Iran's BilateralIntra-industry Trade in Pharmaceutical Industry.

    Science.gov (United States)

    Aghlmand, Siamak; Rahimi, Bahlol; Farrokh-Eslamlou, Hamidreza; Nabilou, Bahram; Yusefzadeh, Hassan

    2018-01-01

    Among non-oil and in trade arena, drug has always been strategic importance and most government especially industrialized countries pay special attention to its production and trade issues. Thus, having a comprehensive view from economic perspective to this section is essential for suggesting intervention. This was a descriptive-analytical and panel study. In this study, gravity model is used to estimate Iran's bilateral intra-industry trade in pharmaceutical products in the 2001-2012 periods. To illustrate the extent of pharmaceutical's intra-industry trade between Iran and its major trading partners, the explanatory variables of market size, income, factor endowments, distance, cultural contributions, and similarities and also special trade arrangements have been applied. Analysis of factors affecting Iran's bilateral intra-industry trade in pharmaceutical industry showed that the average GDP and cultural similarities had a significant positive impact on Iran's bilateral IIT, while the difference in GDP has a negative and significant effect. Coefficients obtained for the geographical distance and the average ratio of total capital to the labor force is not consistent with theoretical expectations. Special trade arrangements did not have significant impact on the extent of bilateral intra-industry trade between Iran and its trading partners. The knowledge of the intra-industry trade between Iran and its trade partners make integration between the countries. Factors affecting this type of trade pattern underlie its development in trade relationship. Therefore, the findings of this study would be useful in helping to develop and implement policies for the expansion of the pharmaceutical trade.

  20. Q4 2017/Q1 2018 Solar Industry Update

    Energy Technology Data Exchange (ETDEWEB)

    Feldman, David J [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Margolis, Robert M [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Hoskins, Jack [U.S. Department of Energy

    2018-05-16

    This technical presentation provides an update on the major trends that occurred in the solar industry in Q4 2017 and Q1 2018. Major topics of focus include global and U.S. supply and demand, module and system price, investment trends and business models, and updates on U.S. government programs supporting the solar industry.

  1. A new e-beam application in the pharmaceutical industry

    International Nuclear Information System (INIS)

    Sadat, Theo; Malcolm, Fiona

    2005-01-01

    The paper presents a new electron beam application in the pharmaceutical industry: an in-line self-shielded atropic transfer system using electron beam for surface decontamination of products entering a pharmaceutical filling line. The unit was developed by Linac Technologies in response to the specifications of a multi-national pharmaceutical company, to solve the risk of microbial contamination entering a filling line housed inside an isolator. In order to fit the sterilization unit inside the pharmaceutical plant, a 'miniature' low-energy (200 keV) electron beam accelerator and e-beam tunnel were designed, all conforming to the pharmaceutical good manufacturing practice (GMP) regulations. Process validation using biological indicators is described, with reference to the regulations governing the pharmaceutical industry. Other industrial applications of a small-sized self-shielded electron beam sterilization unit are mentioned

  2. Border between natural product and drug: Comparison of the related benzoquinones idebenone and coenzyme Q10

    Directory of Open Access Journals (Sweden)

    Nuri Gueven

    2015-04-01

    Full Text Available Coenzyme Q10 is a ubiquitous component of cellular membranes and belongs to the class of benzoquinones that mainly differ with regards to the length and composition of their hydrophobic tail. The characteristic quinone group can accept electrons from various biological sources and is converted by a one electron transfer to the unstable semiquinone or by a two electron transfer to the more stable hydroquinone. This feature makes CoQ10 the bona fide cellular electron transfer molecule within the mitochondrial respiratory chain and also makes it a potent cellular antioxidant. These activities serve as justification for its popular use as food supplement. Another quinone with similarities to the naturally occurring CoQ10 is idebenone, which shares its quinone moiety with CoQ10, but at the same time differs from CoQ10 by the presence of a much shorter, less lipophilic tail. However, despite its similarity to CoQ10, idebenone cannot be isolated from any natural sources but instead was synthesized and selected as a pharmacologically active compound in the 1980s by Takeda Pharmaceuticals purely based on its pharmacological properties. Several recent clinical trials demonstrated some therapeutic efficacy of idebenone in different indications and as a consequence, many practitioners question if the freely available CoQ10 could not be used instead. Here, we describe the molecular and pharmacological features of both molecules that arise from their structural differences to answer the question if idebenone is merely a CoQ10 analogue as frequently perpetuated in the literature or a pharmaceutical drug with entirely different features.

  3. Assessing the Factors Associated With Iran's Intra-Industry Trade in Pharmaceuticals.

    Science.gov (United States)

    Yusefzadeh, Hassan; Hadian, Mohammad; Abolghasem Gorji, Hassan; Ghaderi, Hossein

    2015-03-30

    Pharmaceutical industry is a sensitive and profitable industry. If this industry wants to survive, it should be able to compete well in international markets. So, study of Iran's intra-industry trade (IIT) in pharmaceuticals is essential in order to identify competitiveness potential of country and boost export capability in the global arena. This study assessed the factors associated with Iran's intra-industry trade in pharmaceuticals with the rest of the world during the 2001-2012 periods using seasonal time series data at the four-digit SITC level. The data was collected from Iran's pharmaceutical Statistics, World Bank and International Trade Center. Finally, we discussed a number of important policy recommendations to increase Iran's IIT in pharmaceuticals. The findings indicated that economies of scale, market structure and degree of economic development had a significantly positive impact on Iran's intra-industry trade in pharmaceuticals and tariff trade barriers were negatively related to IIT. Product differentiation and technological advancement didn't have the expected signs. In addition, we found that Iran's IIT in pharmaceuticals have shown an increasing trend during the study period. Thus, the composition of Iran trade in pharmaceuticals has changed from inter-industry trade to intra-industry trade. In order to get more prepared for integration into the global economy, the development of Iran's IIT in pharmaceuticals should be given priority. Therefore, paying attention to IIT could have an important role in serving pharmaceutical companies in relation to pharmaceutical trade.

  4. Quality Systems Implementation in the Pharmaceutical Industry

    African Journals Online (AJOL)

    Nafiisah

    quality standards imposed on local pharmaceutical manufacturers. Keywords: Quality/ .... GMP is concerned with both production and quality control. It is aimed ... in the European pharmaceutical industry in designing their quality systems:.

  5. [Chinese medicine industry 4.0:advancing digital pharmaceutical manufacture toward intelligent pharmaceutical manufacture].

    Science.gov (United States)

    Cheng, Yi-Yu; Qu, Hai-Bin; Zhang, Bo-Li

    2016-01-01

    A perspective analysis on the technological innovation in pharmaceutical engineering of Chinese medicine unveils a vision on "Future Factory" of Chinese medicine industry in mind. The strategy as well as the technical roadmap of "Chinese medicine industry 4.0" is proposed, with the projection of related core technology system. It is clarified that the technical development path of Chinese medicine industry from digital manufacture to intelligent manufacture. On the basis of precisely defining technical terms such as process control, on-line detection and process quality monitoring for Chinese medicine manufacture, the technical concepts and characteristics of intelligent pharmaceutical manufacture as well as digital pharmaceutical manufacture are elaborated. Promoting wide applications of digital manufacturing technology of Chinese medicine is strongly recommended. Through completely informationized manufacturing processes and multi-discipline cluster innovation, intelligent manufacturing technology of Chinese medicine should be developed, which would provide a new driving force for Chinese medicine industry in technology upgrade, product quality enhancement and efficiency improvement. Copyright© by the Chinese Pharmaceutical Association.

  6. The development of Bio-pharmaceutical industry in China: problems and solutions.

    Science.gov (United States)

    Yan, Gujun

    2014-07-01

    Known as the "sunrise industry" of the 21st century, bio-pharmaceutical industry has been a fast-growing global industry, and many countries have been developing this industry as the focus of their national economies. In China, there exists a huge market demand for the development of bio-pharmaceutical industry, but at the present stage the industry is faced with some problems, such as low level of R & D for innovative drugs, and inappropriate capital investment in the industrialization. In order to accelerate the development of China's bio-pharmaceutical industry, it is necessary to take strategic initiatives of improving the technology transfer system, developing the bio-pharmaceutical outsourcing, and building a diversified industrial financing system.

  7. Design, optimization and characterization of coenzyme Q10- and D-panthenyl triacetate-loaded liposomes

    Directory of Open Access Journals (Sweden)

    Çelik B

    2017-07-01

    Full Text Available Burak Çelik,1 Ali Asram Sağıroğlu,1 Samet Özdemir2 1Department of Pharmaceutical Technology, Faculty of Pharmacy, Bezmialem Vakif University, 2Department of Pharmaceutical Technology, Faculty of Pharmacy, Yeditepe University, Istanbul, Turkey Abstract: Coenzyme Q10 (CoQ10 is a lipid-soluble molecule found naturally in many eukaryotic cells and is essential for electron transport chain and energy generation in mitochondria. D-Panthenyl triacetate (PTA is an oil-soluble derivative of D-panthenol, which is essential for coenzyme A synthesis in the epithelium. Liposomal formulations that encapsulate both ingredients were prepared and optimized by applying response surface methodology for increased stability and skin penetration. The optimum formulation comprised 4.17 mg CoQ10, 4.22 mg PTA and 13.95 mg cholesterol per 100 mg of soy phosphatidylcholine. The encapsulation efficiency of the optimized formulation for CoQ10 and PTA was found to be 90.89%±3.61% and 87.84%±4.61%, respectively. Narrow size distribution was achieved with an average size of 161.6±3.6 nm, while a spherical and uniform shape was confirmed via scanning electron microscopy and transmission electron microscopy images. Cumulative release of 90.93% for PTA and 24.41% for CoQ10 was achieved after 24 hours of in vitro release study in sink conditions. Physical stability tests indicated that the optimized liposomes were suitable for storage at 4°C for at least 60 days. The results suggest that the optimized liposomal formulation would be a promising delivery system for both ingredients in various topical applications. Keywords: coenzyme Q10, D-panthenyl triacetate, liposomes, response surface methodology, stability

  8. Various endocrine disorders in children with t(13;14(q10;q10 Robertsonian translocation

    Directory of Open Access Journals (Sweden)

    Byung Ho Choi

    2013-09-01

    Full Text Available Purpose45,XY,t(13;14(q10;q10 karyotype can suggest infertility associated with more or less severe oligospermia in male adults. In addition, 45,XX,t(13;14(q10;q10 karyotype carries reproductive risks such as miscarriage or infertility in female adults. However, reports on the phenotype of this karyotype in children are very rare. This study was done to observe various phenotypes of this karyotype in children.MethodsBetween January 2007 and December 2012, children diagnosed with 45,XY,t(13;14(q10;q10 or 45,XX,t(13;14(q10;q10 karyotype by chromosome analysis were analyzed retrospectively.ResultsEight children (5 boys and 3 girls were diagnosed with 45,XY,t(13;14(q10;q10 or 45,XX,t(13;14(q10;q10 karyotype. They ranged in age from 5 years and 6 months to 12 years and 4 months. The phenotypes of the study patients consisted of 1 hypogonadotrophic hypogonadism, 1 precocious puberty, 3 early puberty, 2 growth hormone deficiency (GHD (partial and 1 idiopathic short stature. As shown here t(13;14(q10;q10 Robertsonian translocation shows a wide range of phenotypes.ConclusionIt can be said that t(13;14(q10;q10 Robertsonian translocation shows various phenotypes from GHD to precocious puberty in children. Further large-scale studies are necessary.

  9. ECONOMIC AND FINANCIAL IMPLICATIONS OF THE PHARMACEUTICAL INDUSTRY IN ROMANIA

    Directory of Open Access Journals (Sweden)

    Georgiana Daniela Minculete Piko

    2014-09-01

    Full Text Available In the wake of the financial crisis, most industries witnessed an economic downturn also boosted by the austerity measures imposed by the state. The pharmaceutical sector is one of the few sectors that followed an upward trend. Although the economic and financial crisis has long taken hold of the entire world, the domino theory did not apply to this industry; instead, the “butterfly effect” became evident. The phrase refers to the fact that the wings of a butterfly create small changes that may finally alter the route of certain elements. In the pharmaceutical industry, minor changes in research and development finally led to spectacular innovations. At present, there are no such big investments in research and development in Romania as there are in Europe; yet, due to mergers and acquisitions between Romanian and foreign companies, the pharmaceutical sector in Romania significantly contributes to the creation of added value in terms of economic development. The added value of the pharmaceutical industry in our country has increased significantly in recent years. The purpose of this article is to highlight the financial and economic significance of the pharmaceutical industry in Romania. This industry is one with an average degree of concentration; thus, the average liquidity and solvency indicators in this sector were calculated with a view to emphasizing its financial independence. The findings of this research indicate a high level of financial independence in this industry, as pharmaceutical companies are able to meet payment deadlines. This study highlights the importance of such an industry in times of economic crisis, the financial stability of the pharmaceutical sector reinforcing the need for massive investment in research and development.

  10. Assessing the Factors Associated With Iran’s Intra-Industry Trade in Pharmaceuticals

    Science.gov (United States)

    Yusefzadeh, Hassan; Hadian, Mohammad; Gorji, Hassan Abolghasem; Ghaderi, Hossein

    2015-01-01

    Background: Pharmaceutical industry is a sensitive and profitable industry. If this industry wants to survive, it should be able to compete well in international markets. So, study of Iran’s intra-industry trade (IIT) in pharmaceuticals is essential in order to identify competitiveness potential of country and boost export capability in the global arena. Methods: This study assessed the factors associated with Iran’s intra-industry trade in pharmaceuticals with the rest of the world during the 2001–2012 periods using seasonal time series data at the four-digit SITC level. The data was collected from Iran’s pharmaceutical Statistics, World Bank and International Trade Center. Finally, we discussed a number of important policy recommendations to increase Iran’s IIT in pharmaceuticals. Results: The findings indicated that economies of scale, market structure and degree of economic development had a significantly positive impact on Iran’s intra-industry trade in pharmaceuticals and tariff trade barriers were negatively related to IIT. Product differentiation and technological advancement didn’t have the expected signs. In addition, we found that Iran’s IIT in pharmaceuticals have shown an increasing trend during the study period. Thus, the composition of Iran trade in pharmaceuticals has changed from inter-industry trade to intra-industry trade. Conclusions: In order to get more prepared for integration into the global economy, the development of Iran’s IIT in pharmaceuticals should be given priority. Therefore, paying attention to IIT could have an important role in serving pharmaceutical companies in relation to pharmaceutical trade. PMID:26156931

  11. Healthcare systems, the State, and innovation in the pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Ignacio José Godinho Delgado

    Full Text Available Abstract: This article discusses the relations between healthcare systems and the pharmaceutical industry, focusing on state support for pharmaceutical innovation. The study highlights the experiences of the United States, United Kingdom, and Germany, developed countries and paradigms of modern health systems (liberal, universal, and corporatist, in addition to Japan, a case of successful catching up. The study also emphasizes the experiences of China, India, and Brazil, large developing countries that have tried different catching up strategies, with diverse histories and profiles in their healthcare systems and pharmaceutical industries. Finally, with a focus on state forms of support for health research, the article addresses the mechanisms for linkage between health systems and the pharmaceutical industry, evaluating the possibilities of Brazil strengthening a virtuous interaction, favoring the expansion and consolidation of the Brazilian health system - universal but segmented ‒ and the affirmation of the innovative national pharmaceutical industry.

  12. RFID in the pharmaceutical industry: addressing counterfeits with technology.

    Science.gov (United States)

    Taylor, Douglas

    2014-11-01

    The use of Radio Frequency Identification (RFID) in the pharmaceutical industry has grown in recent years. The technology has matured from its specialized tracking and retail uses to a systemic part of supply chain management in international pharmaceutical production and distribution. Counterfeit drugs, however, remain a significant challenge for governments, pharmaceutical companies, clinicians, and patients and the use of RFID to track these compounds represents an opportunity for development. This paper discusses the medical, technological, and economic factors that support widespread adoption of RFID technology in the pharmaceutical industry in an effort to prevent counterfeit medicines from harming patients and brand equity.

  13. Mergers and innovation in the pharmaceutical industry.

    Science.gov (United States)

    Comanor, William S; Scherer, F M

    2013-01-01

    Conflicting trends confound the pharmaceutical industry. The productivity of pharmaceutical innovation has declined in recent years. At the same time, the cohort of large companies who are the leading engines of pharmaceutical R&D has become increasingly concentrated. The concurrent presence of these trends is not sufficient to determine causation. In response to lagging innovation prospects, some companies have sought refuge in mergers and acquisitions to disguise their dwindling prospects or gain R&D synergies. On the other hand, the increased concentration brought on by recent mergers may have contributed to the declining rate of innovation. In this paper, we consider the second of these causal relationships: the likely impact of the recent merger wave among the largest pharmaceutical companies on the rate of innovation. In other words, have recent mergers, which may have been taken in response to lagging innovation, represented a self-defeating strategy that only made industry outcomes worse? Copyright © 2012 Elsevier B.V. All rights reserved.

  14. The use of atomic spectroscopy in the pharmaceutical industry for the determination of trace elements in pharmaceuticals.

    Science.gov (United States)

    Lewen, Nancy

    2011-06-25

    The subject of the analysis of various elements, including metals and metalloids, in the pharmaceutical industry has seen increasing importance in the last 10-15 years, as modern analytical instrumentation has afforded analysts with the opportunity to provide element-specific, accurate and meaningful information related to pharmaceutical products. Armed with toxicological data, compendial and regulatory agencies have revisited traditional approaches to the testing of pharmaceuticals for metals and metalloids, and analysts have begun to employ the techniques of atomic spectroscopy, such as flame- and graphite furnace atomic absorption spectroscopy (FAAS, Flame AA or FAA and GFAAS), inductively coupled plasma-atomic emission spectroscopy (ICP-AES) and inductively coupled plasma-mass spectrometry (ICP-MS), to meet their analytical needs. Newer techniques, such as laser-induced breakdown spectroscopy (LIBS) and Laser Ablation ICP-MS (LAICP-MS) are also beginning to see wider applications in the analysis of elements in the pharmaceutical industry.This article will provide a perspective regarding the various applications of atomic spectroscopy in the analysis of metals and metalloids in drug products, active pharmaceutical ingredients (API's), raw materials and intermediates. The application of atomic spectroscopy in the analysis of metals and metalloids in clinical samples, nutraceutical, metabolism and pharmacokinetic samples will not be addressed in this work. Copyright © 2010 Elsevier B.V. All rights reserved.

  15. ETHICAL ASPECTS OF THE COOPERATION BETWEEN PHYSICIAN AND PHARMACEUTICAL INDUSTRY

    Directory of Open Access Journals (Sweden)

    Jože Drinovec

    2001-09-01

    Full Text Available Background. It is not possible to isolated ethical aspects and norms in the work of physician from the professional and scientific ones. The physician will not act contrary to ethical principles if he will work for the interests of the patient and in accordance with scientific knowledge.Present situation and possible solutions. Every physician, especially if working in university institution is co-operating with pharmaceutical industry, at least he is makes the prescriptions and chooses one drug of the possible ones. There are also other aspects of co-operation: clinical trials, writing expertise and lectures at scientific meetings, sponsored by pharmaceutical industry. There are guidelines and codex in Western countries for more than ten years, which regulate the relation between physician and pharmaceutical industry. The most important ones are those from World Health Organisation, European Federation of Pharmaceutical Industries’ Associations’, and International Federation of Pharmaceutical Manufacturers Associations’. Scientific independence of lecturers and writers is tried to be achieved by disclosure of relevant financial relation with pharmaceutical corporation in advance.Conclusions. Physician working with pharmaceutical industry has o follow the guidelines of international professional associations. He/she has to be independent relaying only upon scientific and professional principles seeing primary the benefit of the patient.

  16. Effective executive management in the pharmaceutical industry.

    Science.gov (United States)

    Tran, Hoang; Kleiner, Brian H

    2005-01-01

    Along with the boom in information technology and vast development in genomic and proteomic discoveries, the pharmaceutical and biotech industries have been provided the means and tools to create a new page in medicinal history. They are now able to alter the classic ways to cure complex diseases thanks to the completion of the human genome project. To be able to compete in this industry, pharmaceutical management has to be effective not only internally but also externally in socially acceptable conduct. The first department that requires focus is marketing and sales. As the main driving force to increase revenues and profits, marketing and sales employees should be highly motivated by compensation. Also, customer relationships should be maintained for long-term gain. As important as marketing, research and development requires the financial support as well as the critical decision making to further expand the product pipeline. Similarly, finance and technologies should be adequately monitored and invested to provide support as well as prepare for future expansion. On top of that, manufacturing processes and operations are operated per quality systems and FDA guidelines to ensure high quality. Human Resources, on the other hand, should carry the managing and motivation from upper management through systematic recruitment, adequate training, and fair compensation. Moreover, effective management in a pharmaceutical would also require the social welfare and charity to help patients who cannot afford the treatment as well as improving the organization's image. Last but not least, the management should also prepare for the globalization of the industry. Inevitably, large pharmaceutical companies are merging with each other or acquiring smaller companies to enhance the competitive advantages as well as expand their product mix. For effectiveness in a pharmaceutical industry, management should focus more than just the daily routine tasks and short-term goals. Rather, they

  17. The future of the pharmaceutical, biological and medical device industry

    Directory of Open Access Journals (Sweden)

    Burgess LJ

    2011-09-01

    Full Text Available Lesley J Burgess, Marli TerblancheTREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and University of Stellenbosch, Parow, South AfricaAbstract: Numerous factors contribute to the declining pharmaceutical industry on the one hand and the rapidly growing generic industry together with the growing importance of medical devices and biologicals on the other. It is clear that the pharmaceutical industry is going to undergo a change in the next decade in order to meet the current challenges facing it and ultimately sustain its profitability and growth. This paper aims to identify a number of fairly obvious trends that are likely to have a significant impact on the product development pipeline in the next decade. It is more than clear that the current production pipeline for pharmaceutical, biotechnology and medical device industries is no longer sustainable and that urgent interventions are required in order to maintain its current level of profitability.Keywords: pharmaceutical industry, personalized medicine, trends, generics, biotechnology

  18. 75 FR 41871 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2010-07-19

    ... Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese... and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat... the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmaceutical Texts for Use in the...

  19. Scientific misconduct, the pharmaceutical industry, and the tragedy of institutions.

    Science.gov (United States)

    Cohen-Kohler, Jillian Clare; Esmail, Laura C

    2007-09-01

    This paper examines how current legislative and regulatory models do not adequately govern the pharmaceutical industry towards ethical scientific conduct. In the context of a highly profit-driven industry, governments need to ensure ethical and legal standards are not only in place for companies but that they are enforceable. We demonstrate with examples from both industrialized and developing countries how without sufficient controls, there is a risk that corporate behaviour will transgress ethical boundaries. We submit that there is a critical need for urgent drug regulatory reform. There must be robust regulatory structures in place which enforce corporate governance mechanisms to ensure that pharmaceutical companies maintain ethical standards in drug research and development and the marketing of pharmaceuticals. What is also needed is for the pharmaceutical industry to adopt authentic "corporate social responsibility" policies as current policies and practices are insufficient.

  20. New Product Introduction in the Pharmaceutical Industry

    DEFF Research Database (Denmark)

    Hansen, Klaus Reinholdt Nyhuus

    Due to the limited time of the monopoly provided by patent protection that is used for recouping the R&D investment, pharmaceutical companies focus on keeping time-to-market for new products as short as possible. This process is however getting more uncertain, as the outcome of clinical trials...... is unknown and negotiations with authorities have become harder, making market introduction more difficult. This dissertation treats the new product introduction process in the pharmaceutical industry from an operations perspective. The overarching aim of this dissertation is to improve the planning...... uncertainty and several important industry characteristics. The model is used to gain several insights on the use of risk packaging and on keeping time-to-market short. As capacity in secondary pharmaceutical production is critical for product availability, a capacity planning model for a new drug delivery...

  1. Determinants of Iran’s Bilateral Intra-industry Trade in Pharmaceutical Industry

    Science.gov (United States)

    Aghlmand, Siamak; Rahimi, Bahlol; Farrokh-Eslamlou, Hamidreza; Nabilou, Bahram; Yusefzadeh, Hassan

    2018-01-01

    Among non-oil and in trade arena, drug has always been strategic importance and most government especially industrialized countries pay special attention to its production and trade issues. Thus, having a comprehensive view from economic perspective to this section is essential for suggesting intervention. This was a descriptive-analytical and panel study. In this study, gravity model is used to estimate Iran’s bilateral intra-industry trade in pharmaceutical products in the 2001-2012 periods. To illustrate the extent of pharmaceutical’s intra-industry trade between Iran and its major trading partners, the explanatory variables of market size, income, factor endowments, distance, cultural contributions, and similarities and also special trade arrangements have been applied. Analysis of factors affecting Iran’s bilateral intra-industry trade in pharmaceutical industry showed that the average GDP and cultural similarities had a significant positive impact on Iran’s bilateral IIT, while the difference in GDP has a negative and significant effect. Coefficients obtained for the geographical distance and the average ratio of total capital to the labor force is not consistent with theoretical expectations. Special trade arrangements did not have significant impact on the extent of bilateral intra-industry trade between Iran and its trading partners. The knowledge of the intra-industry trade between Iran and its trade partners make integration between the countries. Factors affecting this type of trade pattern underlie its development in trade relationship. Therefore, the findings of this study would be useful in helping to develop and implement policies for the expansion of the pharmaceutical trade. PMID:29881438

  2. Uneasy subjects: medical students' conflicts over the pharmaceutical industry.

    Science.gov (United States)

    Holloway, Kelly

    2014-08-01

    In this article I report on an investigation of the pharmaceutical industry's influence in medical education. Findings are based on fifty semi-structured interviews with medical students in the United States and Canada conducted between 2010 and 2013. Participant responses support the survey-based literature demonstrating that there is clear and pervasive influence of the pharmaceutical industry in medical education. They also challenge the theory that medical students feel entitled to industry gifts and uncritically accept industry presence. I investigate how medical students who are critical of the pharmaceutical industry negotiate its presence in the course of their medical education. Findings suggest that these participants do not simply absorb industry presence, but interpret it and respond in complex ways. Participants were uncomfortable with industry influence throughout their medical training and found multifaceted ways to resist. They struggled with power relations in medical training and the prevailing notion that industry presence is a normal part of medical education. I argue that this pervasive norm of industry presence is located in neoliberal structural transformations within and outside both education and medicine. The idea that industry presence is normal and inevitable represents a challenge for students who are critical of industry. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

  3. Strategic imperatives for globalization of industries in developing countries: an Indian pharmaceutical industry example.

    Science.gov (United States)

    Srivastava, Rajesh; Chandra, Ashish; Kumar, Girish

    2004-01-01

    The annual global pharmaceutical sales have grown over 466 billion dollars, almost 50% of which comes from North America. Among developing countries, India, with 16% of the world population, accounts for only a small percentage of the global pharmaceutical industry. Until recently, India has had virtually no pharmaceutical industry worth the name producing drugs from basic raw materials and it used to rely mostly on the imports from countries like the USA and England for all its requirements of drugs. On the other hand, India has seen a plethora of multinational pharmaceutical companies come and do business in India. This paper develops a matrix which provides a broad guidance to the mid- to large-size Indian pharmaceutical domestic companies, which should embark on the path to global expansion to establish their might as well.

  4. Macro-economic factors influencing the architectural business model shift in the pharmaceutical industry.

    Science.gov (United States)

    Dierks, Raphaela Marie Louisa; Bruyère, Olivier; Reginster, Jean-Yves; Richy, Florent-Frederic

    2016-10-01

    Technological innovations, new regulations, increasing costs of drug productions and new demands are only few key drivers of a projected alternation in the pharmaceutical industry. The purpose of this review is to understand the macro economic factors responsible for the business model revolution to possess a competitive advantage over market players. Areas covered: Existing literature on macro-economic factors changing the pharmaceutical landscape has been reviewed to present a clear image of the current market environment. Expert commentary: Literature shows that pharmaceutical companies are facing an architectural alteration, however the evidence on the rationale driving the transformation is outstanding. Merger & Acquisitions (M&A) deals and collaborations are headlining the papers. Q1 2016 did show a major slowdown in M&A deals by volume since 2013 (with deal cancellations of Pfizer and Allergan, or the downfall of Valeant), but pharmaceutical analysts remain confident that this shortfall was a consequence of the equity market volatility. It seems likely that the shift to an M&A model will become apparent during the remainder of 2016, with deal announcements of Abbott Laboratories, AbbVie and Sanofi worth USD 45billion showing the appetite of big pharma companies to shift from the fully vertical integrated business model to more horizontal business models.

  5. Pharmaceutical industry marketing: understanding its impact on women's health.

    Science.gov (United States)

    Sufrin, Carolyn B; Ross, Joseph S

    2008-09-01

    The delivery of modern health care entails significant involvement from the pharmaceutical industry, including developing and manufacturing drugs. However, the industry also has tremendous influence on the practice of medicine through its considerable marketing efforts, both to patients through direct to consumer advertising, and to physicians through detailing, providing samples, continuing medical education, and other efforts. This article will review the role that pharmaceutical marketing plays in health care, and the substantial evidence surrounding its influence on patient and physician behaviors, with additional discussion of the medical device industry, all with particular attention to women's health. Understanding the effects of pharmaceutical marketing on women's health, through discussion of relevant examples-including oral contraceptive pills, drugs for premenstrual dysphoric disorder, Pap smear cytology techniques, and neonatal herpes prophylaxis-will help ensure that women receive unbiased, evidenced-based care. We will conclude with a discussion of guidelines that have been proposed by professional organizations, policy makers, and universities, to assist physicians in managing exposure to pharmaceutical marketing.

  6. Quality in the pharmaceutical industry - A literature review.

    Science.gov (United States)

    Haleem, Reham M; Salem, Maissa Y; Fatahallah, Faten A; Abdelfattah, Laila E

    2015-10-01

    The aim of this study is to:a.Highlight the most important guidelines and practices of quality in the pharmaceutical industry.b.Organize such guidelines and practices to create a guide to pave the way for other researchers who would like to dig deeper into these guidelines and practices. A review was conducted of 102 publications; 56 publications were concerned with the pharmaceutical quality directly while 46 publications were concerned with the general quality practices. The content of those sources was analyzed and the following themes were identified:a.Research theme 1: Guidelines of the pharmaceutical quality.b.Research theme 2: General practices recently applied in the pharmaceutical industry. The following guidelines were identified and reviewed: WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines in the research theme I. In research theme II; the following topics were identified and reviewed: quality risk management, quality by design, corrective actions and preventive actions, process capability analysis, Six Sigma, process analytical technology, lean manufacturing, total quality management, ISO series and HACCP. Upon reviewing the previously highlighted guidelines and the practices that are widely applied in the pharmaceutical industry, it was noticed that there is an abundant number of papers and articles that explain the general guidelines and practices but the literature lack those describing application; case studies of the pharmaceutical factories applying those guidelines and significance of those guidelines and practices. It is recommended that the literature would invest more in the area of application and significance of guidelines and practices. New case studies should be done to prove the feasibility of such practices.

  7. APPROACHES TO IMPLEMENTATION OF AN INTEGRATED MANAGEMENT SYSTEM IN THE PHARMACEUTICAL INDUSTRY. GALENICAL PHARMACEUTICAL PRODUCTION

    Directory of Open Access Journals (Sweden)

    Ershova Elena Vladimirovna

    2015-10-01

    Full Text Available This article reviews the issues associated with development of an integrated quality management system and its implementation into a galenical pharmaceutical company. Recently, the Russian pharmaceutical industry has been developing extensively: pharmaceutical clusters are being formed, new and innovative technologies are being developed. For the enterprises producing galenical pharmaceutical products, which feature low prices and a high level of competition, development and implementation of management systems is a way to prove their competitiveness. The purpose of this article is to review the architecture and the key elements of integrated management systems for pharmaceutical enterprises, develop an integrated management system in terms of the upcoming revision of ISO 9001:2015, as well as to describe the benefits of implementation of such systems. The presented approach is the result of an educational project implemented within the framework of the MBA programme in "Master of Business Administration (MBA" in the Federal State Budgetary Educational Institution of Continuing Professional Education Pastukhov State Academy of Industrial Management.

  8. Analysis of International Mergers and Acquisitions in the Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Božo Matić

    2011-07-01

    Full Text Available There are numerous researches which analyze mergers and acquisitions, but most of them do not focus on a certain industry, but their sample considers companies from different industries. This paper focuses on mergers and acquisitions in the pharmaceutical industry. It is assumed that pharmaceutical companies with no experience in mergers and acquisitions achieve better results in relatively small and domestic mergers and acquisitions while pharmaceutical companies with greater experience in mergers and acquisitions are successful even in bigger and international mergers and acquisitions. Bigger mergers and acquisitions and international mergers and acquisitions are more risky for the companies so lack of experience in mergers and acquisitions additionally increases risks during the process of mergers and acquisitions. On average, such increase of the risk results in lower returns for stock owners of pharmaceutical companies.

  9. The pharmaceutical industry in the industrial chemical group: The National Union of Chemical-Pharmaceutical Laboratories (1919-1936

    Directory of Open Access Journals (Sweden)

    Rodríguez Nozal, Raúl

    2011-12-01

    Full Text Available The pharmaceutical industry associations, as it happened with other businesses, had a significant rise during the dictatorship of Primo de Rivera and II Republic. The Cámara Nacional de Industrias Químicas, in Barcelona, represented the national chemical industry to its ultimate assimilation by the Organización Sindical in 1939. In this association, matters relating to pharmaceutical products —which we will specially deal with in this work— were managed by the Unión Nacional de Laboratorios Químico-Farmacéuticos, which defended the interests of pharmaceutical companies in the presence of government authorities, using the resources and mechanisms also managed by business pressure groups. The inclusion of industrial pharmacy in the Chemical lobby separated the pharmaceutical industry from traditional exercise and its corporate environment. This created ups and downs, conflicts of interests and finally, love and hate relationships with their colleagues of the pharmacy work placement and, of course, with the association that represented them: the Unión Farmacéutica Nacional.

    El asociacionismo farmacéutico industrial, al igual que ocurriera con otras actividades empresariales, experimentó un notable auge durante la Dictadura de Primo de Rivera y la II República. La Cámara Nacional de Industrias Químicas, desde Barcelona, representó a la industria química nacional hasta su asimilación definitiva por la Organización Sindical franquista, en 1939. Dentro de esta asociación, los asuntos relacionados con los productos farmacéuticos, a los que prestaremos especial atención en este trabajo, fueron gestionados por la Unión Nacional de Laboratorios Químico- Farmacéuticos, que defendió los intereses de los productores de medicamentos industriales ante las autoridades gubernamentales, utilizando para ello recursos y mecanismos también manejados por otros grupos empresariales de presión. La inclusión de la farmacia industrial

  10. Recent Regulatory Trends in Pharmaceutical Manufacturing and their Impact on the Industry.

    Science.gov (United States)

    Tabersky, Daniel; Woelfle, Michael; Ruess, Juan-Antonio; Brem, Simon; Brombacher, Stephan

    2018-03-30

    The pharmaceutical industry is one of the most regulated industries in Switzerland. Though the concept of good manufacturing practises (GMP) was implemented for chemical production in the early 1990s, the rules and regulations for our industry are in constant evolution. In this article we will highlight the impact of these changes to the industry using three recent guideline up-dates as examples: the implementation of ICH Q3D 'Guideline for elemental impurities', the EU-GMP Guideline Part III Chapter 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities' from 01. June 2015, and the new guidelines to data integrity such as 'PIC/S 041-1 Good Practices for Data Management and Integrity in regulated GMP/GDP environments'. These examples show how scientific approaches help to modernize the control strategies for our products and increase product quality for a better patient safety. The requirements of data integrity regulations are also of interest to industries and universities not working under GxP requirements as they also support the business to improve data quality (traceability) for patent applications, and reduce risk of data falsification.

  11. Metrology in Pharmaceutical Industry - A Case Study

    International Nuclear Information System (INIS)

    Yuvamoto, Priscila D.; Fermam, Ricardo K. S.; Nascimento, Elizabeth S.

    2016-01-01

    Metrology is recognized by improving production process, increasing the productivity, giving more reliability to the measurements and consequently, it impacts in the economy of a country. Pharmaceutical area developed GMP (Good Manufacture Practice) requeriments, with no introduction of metrological concepts. However, due to Nanomedicines, it is expected this approach and the consequent positive results. The aim of this work is to verify the level of metrology implementation in a Brazilian pharmaceutical industry, using a case study. The purpose is a better mutual comprehension by both areas, acting together and governmental support to robustness of Brazilian pharmaceutical area. (paper)

  12. Models for open innovation in the pharmaceutical industry.

    Science.gov (United States)

    Schuhmacher, Alexander; Germann, Paul-Georg; Trill, Henning; Gassmann, Oliver

    2013-12-01

    The nature of the pharmaceutical industry is such that the main driver for its growth is innovation. In view of the vast challenges that the industry has been facing for several years and, in particular, how to manage stagnating research and development (R&D) productivity, pharmaceutical companies have opened their R&D organizations to external innovation. Here, we identify and characterize four new types of open innovator, which we call 'knowledge creator', 'knowledge integrator', 'knowledge translator' and 'knowledge leverager', and which describe current open R&D models. Copyright © 2013 Elsevier Ltd. All rights reserved.

  13. Coenzyme Q10 and Neurological Diseases

    Directory of Open Access Journals (Sweden)

    Gabriele Siciliano

    2009-12-01

    Full Text Available Coenzyme Q10 (CoQ10, or ubiquinone is a small electron carrier of the mitochondrial respiratory chain with antioxidant properties. CoQ10 supplementation has been widely used for mitochondrial disorders. The rationale for using CoQ10 is very powerful when this compound is primary decreased because of defective synthesis. Primary CoQ10 deficiency is a treatable condition, so heightened “clinical awareness” about this diagnosis is essential. CoQ10 and its analogue, idebenone, have also been widely used in the treatment of other neurodegenerative disorders. These compounds could potentially play a therapeutic role in Parkinson’s disease, Huntington’s disease, amyotrophic lateral sclerosis, Friedreich’s ataxia, and other conditions which have been linked to mitochondrial dysfunction. This article reviews the physiological roles of CoQ10, as well as the rationale and the role in clinical practice of CoQ10 supplementation in different neurological diseases, from primary CoQ10 deficiency to neurodegenerative disorders.

  14. New Product Development in the Pharmaceutical Industry: Evidence from a generic market.

    Science.gov (United States)

    Yousefi, Nazila; Mehralian, Gholamhossein; Rasekh, Hamid Reza; Yousefi, Mina

    2017-01-01

    In today's competitive world, there are several strategies to deal with the fast changing environment, among which New product development (NPD) is a common strategy. However, almost half of the resources that companies devote to NPD are spent on products that may fail. This issue is particularly highlighted in the pharmaceutical industry mainly because of a long development-time, low success rate, high capital requirement, and market uncertainty. This study identifies critical success factors of NPD based on the relevant literatures and expert opinions in Iranian pharmaceutical industry, then prioritizes them using the methodology of multiple criteria decision making (MCDM) through analyzing 50 filled questionnaires structured based on the AHP (Analytical Hierarchy Process) approach. Although the NPD success factors seem the same in both generic and bio-generic pharmaceutical industries, the underlying factors and related sub-factors show the different importance in these two industries. However, this study reveal that, the company capabilities is the most important factor affecting new product development success in both pharmaceutical generic and bio-generic industry. The results of this study contribute to create baseline information for pharmaceutical industry especially Iranian pharmaceutical companies to be more effective in budget allocation on improving NPD success factors so that they can boost the success rate of NPD more effectively.

  15. Coenzyme Q10 defects may be associated with a deficiency of Q10-independent mitochondrial respiratory chain complexes

    Directory of Open Access Journals (Sweden)

    Konstantina Fragaki

    Full Text Available BACKGROUND: Coenzyme Q10 (CoQ10 or ubiquinone deficiency can be due either to mutations in genes involved in CoQ10 biosynthesis pathway, or to mutations in genes unrelated to CoQ10 biosynthesis. CoQ10 defect is the only oxidative phosphorylation disorder that can be clinically improved after oral CoQ10 supplementation. Thus, early diagnosis, first evoked by mitochondrial respiratory chain (MRC spectrophotometric analysis, then confirmed by direct measurement of CoQ10 levels, is of critical importance to prevent irreversible damage in organs such as the kidney and the central nervous system. It is widely reported that CoQ10 deficient patients present decreased quinone-dependent activities (segments I + III or G3P + III and II + III while MRC activities of complexes I, II, III, IV and V are normal. We previously suggested that CoQ10 defect may be associated with a deficiency of CoQ10-independent MRC complexes. The aim of this study was to verify this hypothesis in order to improve the diagnosis of this disease. RESULTS: To determine whether CoQ10 defect could be associated with MRC deficiency, we quantified CoQ10 by LC-MSMS in a cohort of 18 patients presenting CoQ10-dependent deficiency associated with MRC defect. We found decreased levels of CoQ10 in eight patients out of 18 (45 %, thus confirming CoQ10 disease. CONCLUSIONS: Our study shows that CoQ10 defect can be associated with MRC deficiency. This could be of major importance in clinical practice for the diagnosis of a disease that can be improved by CoQ10 supplementation.

  16. The Korean Pharmaceutical Industry and the Expansion of the General Pharmaceuticals Market in the 1950-1960s

    Directory of Open Access Journals (Sweden)

    Kyu-Hwan SIHN

    2015-12-01

    Full Text Available After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The

  17. [The Korean Pharmaceutical Industry and the Expansion of the General Pharmaceuticals Market in the 1950-1960s].

    Science.gov (United States)

    Sihn, Kyu-Hwan

    2015-12-01

    After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA) marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The market for

  18. Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices

    Science.gov (United States)

    Raveis, Victoria H.; Friedman, Anne; Rothman, David J.

    2011-01-01

    Health advocacy organizations (HAOs) are influential stakeholders in health policy. Although their advocacy tends to closely correspond with the pharmaceutical industry's marketing aims, the financial relationships between HAOs and the pharmaceutical industry have rarely been analyzed. We used Eli Lilly and Company's grant registry to examine its grant-giving policies. We also examined HAO Web sites to determine their grant-disclosure patterns. Only 25% of HAOs that received Lilly grants acknowledged Lilly's contributions on their Web sites, and only 10% acknowledged Lilly as a grant event sponsor. No HAO disclosed the exact amount of a Lilly grant. As highly trusted organizations, HAOs should disclose all corporate grants, including the purpose and the amount. Absent this disclosure, legislators, regulators, and the public cannot evaluate possible conflicts of interest or biases in HAO advocacy. PMID:21233424

  19. Pfizer and the Challenges of the Global Pharmaceutical Industry 2013 (B)

    DEFF Research Database (Denmark)

    Kratochvil, Renate; Nell, Phillip Christopher

    2017-01-01

    This is part of a case series. The overall case focuses on the overall pharmaceutical market, such as industry structure and trends, as well as the strategic position of innovative (R&D intensive) pharmaceutical companies. Case A starts with a description of Pfizer struggling to hold its position...... as an industry leader and questions whether this is indicative for the current developments of the entire industry, putting big pharmaceutical companies’ power and influence under pressure. Such trends are, for example, slower sales growth, expiring patents, increasing competition from generics, shorter product...... pharmaceutical companies’ (and in particular Pfizer's) strategic moves (such as mega M&As) to conquer recent trends. The reader is then referred back to Pfizer's situation, its recent strategic initiatives, and competitor’s behaviour. Both cases feature comprehensive information and a large number of tables...

  20. Pfizer and the Challenges of the Global Pharmaceutical Industry 2013 (A)

    DEFF Research Database (Denmark)

    Kratochvil, Renate; Nell, Phillip Christopher

    2018-01-01

    This is part of a case series. The overall case focuses on the overall pharmaceutical market, such as industry structure and trends, as well as the strategic position of innovative (R&D intensive) pharmaceutical companies. Case A starts with a description of Pfizer struggling to hold its position...... as an industry leader and questions whether this is indicative for the current developments of the entire industry, putting big pharmaceutical companies’ power and influence under pressure. Such trends are, for example, slower sales growth, expiring patents, increasing competition from generics, shorter product...... pharmaceutical companies’ (and in particular Pfizer's) strategic moves (such as mega M&As) to conquer recent trends. The reader is then referred back to Pfizer's situation, its recent strategic initiatives, and competitor’s behaviour. Both cases feature comprehensive information and a large number of tables...

  1. Quality in the pharmaceutical industry – A literature review

    Science.gov (United States)

    Haleem, Reham M.; Salem, Maissa Y.; Fatahallah, Faten A.; Abdelfattah, Laila E.

    2013-01-01

    Objectives The aim of this study is to:a.Highlight the most important guidelines and practices of quality in the pharmaceutical industry.b.Organize such guidelines and practices to create a guide to pave the way for other researchers who would like to dig deeper into these guidelines and practices. Design A review was conducted of 102 publications; 56 publications were concerned with the pharmaceutical quality directly while 46 publications were concerned with the general quality practices. The content of those sources was analyzed and the following themes were identified:a.Research theme 1: Guidelines of the pharmaceutical quality.b.Research theme 2: General practices recently applied in the pharmaceutical industry. Main outcome measures The following guidelines were identified and reviewed: WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines in the research theme I. In research theme II; the following topics were identified and reviewed: quality risk management, quality by design, corrective actions and preventive actions, process capability analysis, Six Sigma, process analytical technology, lean manufacturing, total quality management, ISO series and HACCP. Results Upon reviewing the previously highlighted guidelines and the practices that are widely applied in the pharmaceutical industry, it was noticed that there is an abundant number of papers and articles that explain the general guidelines and practices but the literature lack those describing application; case studies of the pharmaceutical factories applying those guidelines and significance of those guidelines and practices. Conclusions It is recommended that the literature would invest more in the area of application and significance of guidelines and practices. New case studies should be done to prove the feasibility of such practices. PMID:26594110

  2. Cleaner production at pharmaceutical industry: first steps assessment

    Directory of Open Access Journals (Sweden)

    Edilaine Conceição Rezende

    2015-12-01

    Full Text Available The Cleaner Production (CP is an environmental management system effective to comply the environmental obligations and promote sustainable development of enterprises. In this study, the implementing possibilities of CP practices were evaluated to pharmaceutical industry, through prior identification procedures for Pharmaceutical Manufacturing Practices. The study was conducted in a scientific and health care institution, which produces pharmaceutical drugs and makes assistance for public health. The production process was evaluated and made a survey of the main points of waste and sewage generations in each stage, in order to diagnose the measures of CP established and propose new actions. Thus, by using this tool, it was possible to demonstrate the reduction of environmental impacts associated with pharmaceutical production. The Pharmaceutical Manufacturing Practices also contributed to the implementation of measures CP, preserving the final product quality, and generating environmental and economic benefits.

  3. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2013-04-26

    ...] Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food... announcing the availability of a guidance for industry entitled ``Regulatory Classification of Pharmaceutical... on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This...

  4. Topical treatment with coenzyme Q10-containing formulas improves skin's Q10 level and provides antioxidative effects.

    Science.gov (United States)

    Knott, Anja; Achterberg, Volker; Smuda, Christoph; Mielke, Heiko; Sperling, Gabi; Dunckelmann, Katja; Vogelsang, Alexandra; Krüger, Andrea; Schwengler, Helge; Behtash, Mojgan; Kristof, Sonja; Diekmann, Heike; Eisenberg, Tanya; Berroth, Andreas; Hildebrand, Janosch; Siegner, Ralf; Winnefeld, Marc; Teuber, Frank; Fey, Sven; Möbius, Janne; Retzer, Dana; Burkhardt, Thorsten; Lüttke, Juliane; Blatt, Thomas

    2015-01-01

    Ubiquinone (coenzyme Q10, Q10) represents an endogenously synthesized lipid-soluble antioxidant which is crucial for cellular energy production but is diminished with age and under the influence of external stress factors in human skin. Here, it is shown that topical Q10 treatment is beneficial with regard to effective Q10 replenishment, augmentation of cellular energy metabolism, and antioxidant effects. Application of Q10-containing formulas significantly increased the levels of this quinone on the skin surface. In the deeper layers of the epidermis the ubiquinone level was significantly augmented indicating effective supplementation. Concurrent elevation of ubiquinol levels suggested metabolic transformation of ubiquinone resulting from increased energy metabolism. Incubation of cultured human keratinocytes with Q10 concentrations equivalent to treated skin showed a significant augmentation of energy metabolism. Moreover, the results demonstrated that stressed skin benefits from the topical Q10 treatment by reduction of free radicals and an increase in antioxidant capacity. © 2015 International Union of Biochemistry and Molecular Biology.

  5. Negative environmental impacts of antibiotic-contaminated effluents from pharmaceutical industries.

    Science.gov (United States)

    Bielen, Ana; Šimatović, Ana; Kosić-Vukšić, Josipa; Senta, Ivan; Ahel, Marijan; Babić, Sanja; Jurina, Tamara; González Plaza, Juan José; Milaković, Milena; Udiković-Kolić, Nikolina

    2017-12-01

    Effluents from pharmaceutical industries are recognized as significant contributors to aquatic pollution with antibiotics. Although such pollution has been mostly reported in Asia, knowledge on industrial discharges in other regions of the world, including Europe, and on the effects associated with such exposures is still limited. Thus, we performed chemical, microbiological and ecotoxicological analyses of effluents from two Croatian pharmaceutical industries during four seasons. In treated effluents of the company synthesizing macrolide antibiotic azithromycin (AZI), the total concentration of AZI and two macrolide by-products from its synthesis was 1-3 orders of magnitude higher in winter and springtime (up to 10.5 mg/L) than during the other two seasons (up to 638 μg/L). Accordingly, the highest total concentrations (up to 30 μg/L) in the recipient river were measured in winter and spring. Effluents from second company formulating veterinary antibiotics contained fluoroquinolones, trimethoprim, sulfonamides and tetracyclines ranging from low μg/L to approx. 200 μg/L. Low concentrations of these antibiotics, from below the limit of quantification to approx. few μg/L, have also been measured in the recipient stream. High frequency of culturable bacteria resistant to AZI (up to 83%) or sulfamethazine (up to 90%) and oxytetracycline (up to 50%) were also found in studied effluents. Finally, we demonstrated that toxicity to algae and water fleas often exceeded the permitted values. Most highly contaminated effluents induced multiple abnormalities in zebrafish embryos. In conclusion, using a wide array of analyses we have demonstrated that discharges from pharmaceutical industries can pose a significant ecological and public health concern due to their toxicity to aquatic organisms and risks for promoting development and spread of antibiotic resistance. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. A first case of primary amenorrhea with i(X(qter---q10::---qter, rob(13;14(q10;q10, inv(9(p13q33 karyotype

    Directory of Open Access Journals (Sweden)

    Seema Korgaonkar

    2011-01-01

    Full Text Available Primary amenorrhea (PA refers to the absence of menarche by the age of 16-18 years although secondary sexual characters are developed. PA occurs in 1-3% of women in the reproductive age group. Various factors such as anatomical, genetic and hormonal factors reported to influence PA. We report triple chromosomal abnormalities of rob(13;14(q10;q10,inv(9(p13q33, i(Xq(qter---q10::---qter in a case of PA and short stature. Though proband has multiple chromosome aberrations, genotypic effect of only i(Xq is evident as proband has PA and short stature. The rob(13;14 and inv(9, which are paternally derived may have role in later reproductive age. Therefore, chromosomal analysis is essential in such cases for the accurate diagnosis and management of the disease.

  7. Psychiatric Resident and Faculty Views on and Interactions with the Pharmaceutical Industry

    Science.gov (United States)

    Misra, Sahana; Ganzini, Linda; Keepers, George

    2010-01-01

    Objective: Sales visits, or detailing, by pharmaceutical industry representatives at academic institutions has been increasingly criticized. The authors surveyed psychiatric residents and faculty members on their views and interactions with representatives of the pharmaceutical industry. Methods: In 2007, a 46-item online survey measuring…

  8. Update on the Pharmaceutical Industry | McDonald | Southern ...

    African Journals Online (AJOL)

    The Sunday Times Business Times published a supplement on the pharmaceutical industry on 30 November 2003. This has been an extremely dynamic environment and one that will be affected by impending legislative change. The objective of the survey was to provide some insight into the current status of the industry ...

  9. Development paths of China's agricultural Pharmaceutical industry under Eco-agriculture background.

    Science.gov (United States)

    Li, Jinkai; Gong, Liutang; Ji, Xi; Zhang, Jin; Miao, Pei

    2014-07-01

    Using pesticides has double effects. On one hand, it contributes to pests control and regulates the growth of crops; On the other hand, it does harm to the environment. To develop ecological agriculture should not only emphasize the output level of agriculture to pursuit of economic efficiency, but also need to keep the ecological environment protected and focus on the social benefits during the development of the industry. As a large agricultural country in the world, China is vigorously promoting the development of ecological agriculture, which is bound to put forward to developing the pesticide industry and green ecological development requirements to promote the transformation and upgrading of agricultural pharmaceutical industry. This paper discusses the mechanism of pesticide pollution on the ecological environment and analyzes China's agricultural problems in the pharmaceutical industry. Then study on the development of Chinese green pesticides and try to find the proper paths of agricultural pharmaceutical to achieve industrial upgrading.

  10. Biochemical Assessment of Coenzyme Q10 Deficiency

    Directory of Open Access Journals (Sweden)

    Juan Carlos Rodríguez-Aguilera

    2017-03-01

    Full Text Available Coenzyme Q10 (CoQ10 deficiency syndrome includes clinically heterogeneous mitochondrial diseases that show a variety of severe and debilitating symptoms. A multiprotein complex encoded by nuclear genes carries out CoQ10 biosynthesis. Mutations in any of these genes are responsible for the primary CoQ10 deficiency, but there are also different conditions that induce secondary CoQ10 deficiency including mitochondrial DNA (mtDNA depletion and mutations in genes involved in the fatty acid β-oxidation pathway. The diagnosis of CoQ10 deficiencies is determined by the decrease of its content in skeletal muscle and/or dermal skin fibroblasts. Dietary CoQ10 supplementation is the only available treatment for these deficiencies that require a rapid and distinct diagnosis. Here we review methods for determining CoQ10 content by HPLC separation and identification using alternative approaches including electrochemical detection and mass spectrometry. Also, we review procedures to determine the CoQ10 biosynthesis rate using labeled precursors.

  11. Pharmaceutical industry and trade liberalization using computable general equilibrium model.

    Science.gov (United States)

    Barouni, M; Ghaderi, H; Banouei, Aa

    2012-01-01

    Computable general equilibrium models are known as a powerful instrument in economic analyses and widely have been used in order to evaluate trade liberalization effects. The purpose of this study was to provide the impacts of trade openness on pharmaceutical industry using CGE model. Using a computable general equilibrium model in this study, the effects of decrease in tariffs as a symbol of trade liberalization on key variables of Iranian pharmaceutical products were studied. Simulation was performed via two scenarios in this study. The first scenario was the effect of decrease in tariffs of pharmaceutical products as 10, 30, 50, and 100 on key drug variables, and the second was the effect of decrease in other sectors except pharmaceutical products on vital and economic variables of pharmaceutical products. The required data were obtained and the model parameters were calibrated according to the social accounting matrix of Iran in 2006. The results associated with simulation demonstrated that the first scenario has increased import, export, drug supply to markets and household consumption, while import, export, supply of product to market, and household consumption of pharmaceutical products would averagely decrease in the second scenario. Ultimately, society welfare would improve in all scenarios. We presents and synthesizes the CGE model which could be used to analyze trade liberalization policy issue in developing countries (like Iran), and thus provides information that policymakers can use to improve the pharmacy economics.

  12. Update on the Pharmaceutical Industry | McDonald | Southern ...

    African Journals Online (AJOL)

    ... Times published a supplement on the pharmaceutical industry on 30 November 2003. This has been an extremely dynamic environment and one that will be affected by impending legislative change. The objective of the survey was to provide some insight into the current status of the industry – special attention was paid ...

  13. [The pharmaceutical industry in scandal: Mercury or Aesculapius?].

    Science.gov (United States)

    Offerhaus, L

    2004-12-18

    During the last decade public sympathy for the pharmaceutical industry has gradually been eroded because of excessive protectionism and profit margins. Its reputation as a healthy, profitable and prosperous industry has recently been seriously damaged by several errors of judgement. Data from early trials proved to be less positive than expected. The responsible drug manufacturers decided to cover the results up. So far the pharmaceutical industry has managed to weather the criticism, but recently a multitude of damaging data was published by an unexpected outsider. Angell, a former editor in chief of one of the most respected, peer-reviewed medical journals in the world, the New England Journal of Medicine, decided to collect such data and to analyze them critically. She also used this analysis to draw up recommendations for improving of what she regarded as an unhealthy situation. The book gained bestseller status on the American market and received much praise from reviewers. Although quickly denounced by the industry as controversial and excessively negative, it contains a lot of data, opinions and conclusions that also apply directly to the European situation.

  14. Electrochemical treatment of pharmaceutical and industrial wastewater by anodic oxidation

    International Nuclear Information System (INIS)

    Menapace, H. M.; Fellerer, M.; Treschnitzer, M.

    2009-01-01

    In modern medicine pharmaceuticals play a decisive role: because of an increased life expectancy and intensive care medicine an increasing amount of pharmaceuticals is produced. thus these substances are consumed in a mass of tons per year in industrialized countries. Wastewater effluents from sewage treatment plants (STP) are important point sources for residues of pharmaceuticals and complexing agents in the aquatic environment. For this reason a research project, which started in December 2006, was established to eliminate pharmaceutical substances and complexing agents found in wastewater as micropollutants. (Author)

  15. [Innovation in pharmaceutical and health biotechnology industries: challenges for a virtuous agenda].

    Science.gov (United States)

    Vargas, Marco; Gadelha, Carlos Augusto Grabois; Costa, Laís Silveira; Maldonado, José

    2012-12-01

    Pharmaceutical and biotechnology industries comprise a major production subsystem of the health industrial complex in Brazil. It stands out for both its economic importance and its prominent role in developing new technologies in strategic areas. Strengthening the local production of generic drugs in the last decade has significantly increased the number of Brazilian companies in the local pharmaceutical market and has been an important turning point for this industry's growth. However, there remain major structural bottlenecks both in terms of production and continuous innovation. These bottlenecks reveal the high vulnerability of the Brazilian National Health System and point to the need of public policies that promote strengthening the production base and innovation in the pharmaceutical industry and that at the same time meet health-related social demands in health in Brazil.

  16. Identifying and prioritizing industry-level competitiveness factors: evidence from pharmaceutical market.

    Science.gov (United States)

    Shabaninejad, Hosein; Mehralian, Gholamhossein; Rashidian, Arash; Baratimarnani, Ahmad; Rasekh, Hamid Reza

    2014-04-03

    Pharmaceutical industry is knowledge-intensive and highly globalized, in both developed and developing countries. On the other hand, if companies want to survive, they should be able to compete well in both domestic and international markets. The main purpose of this paper is therefore to develop and prioritize key factors affecting companies' competitiveness in pharmaceutical industry. Based on an extensive literature review, a valid and reliable questionnaire was designed, which was later filled up by participants from the industry. To prioritize the key factors, we used the Technique for Order Preference by Similarity to Ideal Solution (TOPSIS). The results revealed that human capital and macro-level policies were two key factors placed at the highest rank in respect of their effects on the competitiveness considering the industry-level in pharmaceutical area. This study provides fundamental evidence for policymakers and managers in pharma context to enable them formulating better polices to be proactively competitive and responsive to the markets' needs.

  17. Novel formulation and evaluation of a Q10-loaded solid lipid nanoparticle cream: in vitro and in vivo studies

    Directory of Open Access Journals (Sweden)

    Farboud ES

    2011-03-01

    Full Text Available Effat Sadat Farboud, Saman Ahmad Nasrollahi, Zahra TabbakhiDepartment of Pharmaceutics, School of Pharmacy, Tehran University of Medical Sciences, Tehran, IranAbstract: Solid lipid nanoparticles (SLNs of coenzyme Q10 (CoQ10 were formulated by a high-pressure homogenization method. The best formulation of SLN dispersion consisted of 13% lipid (cetyl palmitate or stearic acid, 8% surfactant (Tween 80 or Tego Care 450, and water. Stability tests, particle size analysis, differential scanning calorimetry, transmission electron microscopy, and release study were conducted to find the best formulation. A simple cream of CoQ10 and a cream containing CoQ10-loaded SLNs were prepared and compared on volunteers aged 20–30 years. SLNs with particle size between 50 nm and100 nm exhibited the most suitable stability. In vitro release profiles of CoQ10 from simple cream, SLN alone, and CoQ10-loaded SLN cream showed prolonged release for SLNs compared with the simple cream, whereas there was no significant difference between SLN alone and SLN in cream. In vitro release studies also demonstrated that CoQ10-loaded SLN and SLN cream possessed a biphasic release pattern in comparison with simple cream. In vivo skin hydration and elasticity studies on 25 volunteers suggested good dermal penetration and useful activity of Q10 on skin as a hydratant and antiwrinkle cream.Keywords: coenzyme Q10, SLN, release study 

  18. 76 FR 64945 - Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent...

    Science.gov (United States)

    2011-10-19

    ... FEDERAL TRADE COMMISSION [File No. 111 0166] Teva Pharmaceutical Industries Ltd. and Cephalon, Inc... Consent Orders (``Consent Agreement'') from Teva Pharmaceutical Industries Ltd. (``Teva'') and Cephalon... Pharmaceutical, Inc. (``Par'') all of Teva's rights and assets relating to its generic transmucosal fentanyl...

  19. Recent trends in laboratory automation in the pharmaceutical industry.

    Science.gov (United States)

    Rutherford, M L; Stinger, T

    2001-05-01

    The impact of robotics and automation on the pharmaceutical industry over the last two decades has been significant. In the last ten years, the emphasis of laboratory automation has shifted from the support of manufactured products and quality control of laboratory applications, to research and development. This shift has been the direct result of an increased emphasis on the identification, development and eventual marketing of innovative new products. In this article, we will briefly identify and discuss some of the current trends in laboratory automation in the pharmaceutical industry as they apply to research and development, including screening, sample management, combinatorial chemistry, ADME/Tox and pharmacokinetics.

  20. [Legislation on the pharmaceutical industry in Morocco during the French protectorate 1912 - 1956].

    Science.gov (United States)

    Nhaili, Hicham; Taoufik, Jamal

    2015-06-01

    In Morocco, the pharmaceutical industry was born with the French protectorate. She knew a great evolution: from a limited production for local needs, it became an important activity, organized to export pharmaceutical patent medicines. This article revisits the birth and history of this industry during the protectorate. It refers to the situation at the time by listing some examples of active establishments and some specialities marketed. It also aims to increase knowledge about the industry and provides an overview of the situation of practitioners remembering the texts governing the profession. Based on the available literature, we examined and analyzed the arrangements related to the establishment, organization and evolution of the pharmaceutical industry.

  1. [Pharmaceutical product quality control and good manufacturing practices].

    Science.gov (United States)

    Hiyama, Yukio

    2010-01-01

    This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

  2. Long-Term Collaboration Network Based on ClinicalTrials.gov Database in the Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Heyoung Yang

    2018-01-01

    Full Text Available Increasing costs, risks, and productivity problems in the pharmaceutical industry are important recent issues in the biomedical field. Open innovation is proposed as a solution to these issues. However, little statistical analysis related to collaboration in the pharmaceutical industry has been conducted so far. Meanwhile, not many cases have analyzed the clinical trials database, even though it is the information source with the widest coverage for the pharmaceutical industry. The purpose of this study is to test the clinical trials information as a probe for observing the status of the collaboration network and open innovation in the pharmaceutical industry. This study applied the social network analysis method to clinical trials data from 1980 to 2016 in ClinicalTrials.gov. Data were divided into four time periods—1980s, 1990s, 2000s, and 2010s—and the collaboration network was constructed for each time period. The characteristic of each network was investigated. The types of agencies participating in the clinical trials were classified as a university, national institute, company, or other, and the major players in the collaboration networks were identified. This study showed some phenomena related to the pharmaceutical industry that could provide clues to policymakers about open innovation. If follow-up studies were conducted, the utilization of the clinical trial database could be further expanded, which is expected to help open innovation in the pharmaceutical industry.

  3. "But doctors do it...": nurses' views of gifts and information from the pharmaceutical industry.

    Science.gov (United States)

    Jutel, Annemarie; Menkes, David B

    2009-06-01

    Most nurses, like their physician counterparts, lack education regarding pharmaceutical marketing strategies, and little is known of their beliefs and practices regarding this industry. Nurses are increasingly targeted by pharmaceutical companies as they become more involved in prescription and as policies restrict pharmaceutical companies' contact with physicians. To assess nurses' beliefs and reported practices concerning pharmaceutical marketing and sponsorship strategies. We conducted parallel Web- and paper-based surveys of a sample of senior registered nurses employed by government-funded health boards in 2 regions of New Zealand to explore their contact with the pharmaceutical industry as well as their beliefs and practices regarding information, gifts, and sponsorship provided by pharmaceutical companies. Returns were tested using Fisher's exact test to determine consistency in response between regions. Results for key outcome variables, including attitude toward the value of industry-derived information, were analyzed by region and in aggregate. Most nurses had contact with pharmaceutical sales representatives (69/106), accepted gifts from representatives (79/105), and believed information from the pharmaceutical industry probably improved their practice (71/106). Half believed that they would be able to detect misleading information if it were present, and 35% believed that accepting gifts and sponsorship was ethically acceptable. We found positive associations between the belief that information from the industry improved practice and reported acceptance of conference funding (OR 3.63; 95% CI 1.41 to 11.55), free food (OR 3.24; 95% CI 2.03 to 7.55), or gifts (OR 3.52; 95% CI 1.38 to 8.95). Nurses generally acknowledge the presence of pharmaceutical marketing in the hospital and the ethical challenges it presents; nonetheless, they also generally accept marketing gifts and may underestimate both the ethical challenges and their own susceptibility to

  4. LEAN AND SIX SIGMA CONCEPTS APPLICATION IN PHARMACEUTICAL INDUSTRY

    Directory of Open Access Journals (Sweden)

    Katarina Pavlović

    2012-03-01

    Full Text Available LEAN thinking and Six Sigma have been utilized by manufacturing industries to decrease cost and improve quality and productivity by reducing variation and production defects [1]. Because of the dramatic successes in manufacturing, there is rising interest among companies in the pharmaceutical industry, which chooses to implement LEAN in order to accomplish such goals as decreased wait time to release product to the market, reduce production waste, and improve communication with end users and raize quality level both in the production and in testing laboratories. In this article, basics of LEAN and Six Sigma are presented and suggestion was given for application of their concepts in pharmaceutical industry together with harmonization with legal regulation represented by requirements Good Manufacturing Practice (cGMP, in order to work "smarter", more cost-effectively and avoid was ting time and other resources.

  5. LEAN AND SIX SIGMA CONCEPTS - APPLICATION IN PHARMACEUTICAL INDUSTRY

    Directory of Open Access Journals (Sweden)

    Katarina Pavlović

    2011-06-01

    Full Text Available LEAN thinking and Six Sigma have been utilized by manufacturing industries to decrease cost and improve quality and productivity by reducing variation and production defects. Because of the dramatic successes in manufacturing, there is rising interest among companies in the pharmaceutical industry, which choose to implement LEAN in order to accomplish such goals as decreased wait time to release product to the market, reduce production waste, improve communication with end users and raise quality level both in the production and in testing laboratories. In this article, basics of LEAN and Six Sigma are presented and suggestion was given for application of their concepts in pharmaceutical industry together with harmonization with legal regulation represented by requirements Good Manufacturing Practice (cGMP, in order to work "smarter", more cost- effectively and avoid wasting time and other resources.

  6. Environmental management practices in the Lebanese pharmaceutical industries: implementation strategies and challenges.

    Science.gov (United States)

    Massoud, May A; Makarem, N; Ramadan, W; Nakkash, R

    2015-03-01

    This research attempts to provide an understanding of the Lebanese pharmaceutical industries' environmental management strategies, priorities, and perceptions as well as drivers, barriers, and incentives regarding the implementation of the voluntary ISO 14001 Environmental Management System. Accordingly, a semistructured in-depth interview was conducted with the pharmaceutical industries. The findings revealed a significant lack of knowledge about the standard among the industries. The main perceived drivers for adopting the ISO 14001 are improving the companies' image and overcoming international trade. The main perceived barriers for acquiring the standard are the lack of government support and the fact that ISO 14001 is not being legally required or enforced by the government. Moreover, results revealed that adopting the ISO 14001 standard is not perceived as a priority for the Lebanese pharmaceutical industries. Although the cost of certification was not considered as a barrier for the implementation of ISO 14001, the majority of the pharmaceutical industries are neither interested nor willing to adopt the Standard if they are not exposed to any regulatory pressure or external demand. They are more concerned with quality and safety issues with the most adopted international standard among the industries being the ISO 9001 quality management system. This study highlights the aspect that financial barriers are not always the hurdles for implementing environmental management strategies in developing countries and underscores the need for regulatory frameworks and enforcement.

  7. Globalization in the pharmaceutical industry, Part II.

    Science.gov (United States)

    Casadio Tarabusi, C; Vickery, G

    1998-01-01

    This is the second of a two-part report on the pharmaceutical industry. Part II begins with a discussion of foreign direct investment and inter-firm networks, which covers international mergers, acquisitions, and minority participation; market shares of foreign-controlled firms; international collaboration agreements (with a special note on agreements in biotechnology); and licensing agreements. The final section of the report covers governmental policies on health and safety regulation, price regulation, industry and technology, trade, foreign investment, protection of intellectual property, and competition.

  8. Evaluating the impact of Brexit on the pharmaceutical industry.

    Science.gov (United States)

    Kazzazi, Fawz; Pollard, Cleo; Tern, Paul; Ayuso-Garcia, Alejandro; Gillespie, Jack; Thomsen, Inesa

    2017-01-01

    The UK Pharmaceutical Industry is arguably one of the most important industries to consider in the negotiations following the Brexit vote. Providing tens of thousands of jobs and billions in tax revenue and research investment, the importance of this industry cannot be understated. At stake is the global leadership in the sector, which produces some of the field's most influential basic science and translation work. However, interruptions and losses may occur at multiple levels, affecting patients, researchers, universities, companies and government. By understanding the current state of pharmaceutical sector, the potential effect of leaving the European Union (EU) on this successful industry can be better understood. This paper aims to address the priorities for negotiations by collating the analyses of professionals in the field, leading companies and non-EU member states. A government healthcare policy advisor and Chief Science Officer (CSO) for a major pharmaceutical firm were consulted to scope the paper. In these discussions, five key areas were identified: contribution, legislative processes, regulatory processes, research and outcomes, commercial risk. Multiple search engines were utilised for selecting relevant material, predominantly PubMed and Google Scholar. To supplement this information, Government documents were located using the "GOV.UK" publications tool, and interviews and commentaries were found through the Google News search function. With thorough investigation of the literature, we propose four foundations in the advancement of negotiations. These prioritise: negotiation of 'associated country' status, bilaterally favourable trade agreements, minimal interruption to regulatory bodies and special protection for the movement of workforce in the life sciences industry.

  9. The case for entrepreneurship in R&D in the pharmaceutical industry.

    Science.gov (United States)

    Douglas, Frank L; Narayanan, V K; Mitchell, Lesa; Litan, Robert E

    2010-09-01

    A lack of entrepreneurial behaviour has often been highlighted as a contributor to the decline in the research and development (R&D) productivity of the pharmaceutical industry. Here, we present an assessment of entrepreneurship in the industry, based on interviews with 26 former and current leaders of R&D departments at major pharmaceutical and biotechnology companies. Factors are highlighted that could be important in promoting entrepreneurial behaviour, which might serve as a catalyst for revitalizing R&D productivity.

  10. [The attitude of physicians regarding the promotion strategies of the pharmaceutical industry].

    Science.gov (United States)

    Castresana, Leonardo; Mejia, Raul; Aznar, Mireya

    2005-01-01

    Pharmaceutical companies invest large sums of money promoting their products. They use a multifaceted approach to drug promotion, incorporating techniques such as hospital and office detailing by pharmaceutical representatives. Although these practices are commonly used, little has been published about the attitude of physicians concerning their interaction with the pharmaceutical industry. We performed a cross sectional anonymous survey to identify the extent of and attitudes towards the relationship between the physicians and the pharmaceutical industry and its representatives with its impact on the knowledge, attitude and behavior of the physicians. Internists, cardiologists and dermatologists who work in ambulatory settings from private and public hospitals in Buenos Aires city participated in this study, 44% were female, 35% residents, 65% staff physicians, averaging 41 years of age. Of these, 86% receive medical samples frecuently, 39% desk gifts, 19% invitations to congresses and 12% free lunches. Half of the doctors believe that receiving benefits from the pharmaceutical industry has an influence on medical prescription, but only 27% accept this as influential in their own prescriptions. Residents consider, more frequently than others, that these activities affect their decisions, (42% vs. 18% p = 0.007, global 30%). Most of the participants consider appropriate receiving these benefits, although 35% think that they affect the final price of medications. In conclusion, there is a high level of interaction between the pharmaceutical industry and our medical population. Although the latter recognize the influence of these interactions on prescriptions and the elevation of the cost of the final product, they find it appropriate to receive benefits.

  11. Applied statistics in the pharmaceutical industry with case studies using S-PLUS

    CERN Document Server

    Krause, Andreas

    2001-01-01

    The purpose of this book is to provide a general guide to statistical methods used in the pharmaceutical industry, and to illustrate how to use S-PLUS to implement these methods. Specifically, the goal is to: *Illustrate statistical applications in the pharmaceutical industry; *Illustrate how the statistical applications can be carried out using S-PLUS; *Illustrate why S-PLUS is a useful software package for carrying out these applications; *Discuss the results and implications of a particular application; The target audience for this book is very broad, including: *Graduate students in biostatistics; *Statisticians who are involved in the industry as research scientists, regulators, academics, and/or consultants who want to know more about how to use S-PLUS and learn about other sub-fields within the indsutry that they may not be familiar with; *Statisticians in other fields who want to know more about statistical applications in the pharmaceutical industry.

  12. Is Industry-University Interaction Promoting Innovation in the Brazilian Pharmaceutical Industry?

    Science.gov (United States)

    Paranhos, Julia; Hasenclever, Lia

    2011-01-01

    This paper analyses industry-university interaction and its characteristics in the Brazilian pharmaceutical system of innovation, taking account of the relevance of company strategies, the approach of the universities and the actions of government. By analysing primary and secondary data the authors show that, for as long as corporate investment…

  13. ASTM and ASME-BPE Standards--Complying with the Needs of the Pharmaceutical Industry.

    Science.gov (United States)

    Huitt, William M

    2011-01-01

    Designing and building a pharmaceutical facility requires the owner, engineer of record, and constructor to be knowledgeable with regard to the industry codes and standards that apply to this effort. Up until 1997 there were no industry standards directed at the needs and requirements of the pharmaceutical industry. Prior to that time it was a patchwork effort at resourcing and adopting nonpharmaceutical-related codes and standards and then modifying them in order to meet the more stringent requirements of the Food and Drug Administration (FDA). In 1997 the American Society of Mechanical Engineers (ASME) published the first Bioprocessing Equipment (BPE) Standard. Through harmonization efforts this relatively new standard has brought together, scrutinized, and refined industry accepted methodologies together with FDA compliance requirements, and has established an American National Standard that provides a comprehensive set of standards that are integral to the pharmaceutical industry. This article describes various American National Standards, including those developed and published by the American Society for Testing and Materials (ASTM), and how they apply to the pharmaceutical industry. It goes on to discuss the harmonization effort that takes place between the various standards developers in an attempt to prevent conflicts and omissions between the many standards. Also included are examples of tables and figures taken from the ASME-BPE Standard. These examples provide the reader with insight to the relevant content of the ASME-BPE Standard. Designing and building a pharmaceutical facility requires the owner, engineer of record, and constructor to be knowledgeable with regard to the industry codes and standards that apply to this effort. Up until 1997 there were no industry standards directed at the needs and requirements of the pharmaceutical industry. Prior to that time it was a patchwork effort at resourcing and adopting nonpharmaceutical-related codes and

  14. What residents don't know about physician-pharmaceutical industry interactions.

    Science.gov (United States)

    Watkins, Raquel S; Kimberly, James

    2004-05-01

    Little is known about the knowledge and skills internal medicine residents need to interact appropriately with pharmaceutical industry representatives. The authors conducted a needs assessment of current knowledge and preferences for potential components of a new educational initiative among residents. In 2001, a two-page questionnaire using a five-point ordinal scale was mailed to all internal medicine residents and faculty at one institution. Analysis included use of Wilcoxon two-sample test. Response rates were 97% (85/88) for residents and 79% (86/109) for faculty. Residents and faculty's knowledge about formal position statements or literature on the impact of marketing strategies on prescribing patterns, drug marketing costs, or how pharmaceutical representatives are trained to interact with physicians was very limited. Most responders felt residents should learn to critically interpret promotional materials, recognize potential for conflict of interest, and consider how patients perceive the physician-pharmaceutical industry relationship. More faculty than residents valued including position statements (66% versus 39%, p marketing on prescribing patterns (70% versus 41%, p education. Only one-half or fewer favored small-group discussions, lecture series, critical-reading skills seminars, or panel discussions. Internal medicine residents and faculty reported low levels of knowledge about physician-pharmaceutical industry relationships. Some consensus about educational components existed, but optimal educational formats remain uncertain. A six-hour curriculum to address this complex, emotionally charged topic was developed, implemented, and evaluated.

  15. Radiation protection in the pharmaceutical-chemical industry

    International Nuclear Information System (INIS)

    Griesser, R.

    1992-01-01

    Some aspects of the use of ionizing radiation in research in the pharmaceutical and chemical industries will be discussed, the emphasis being placed on the handling of open radioactive materials in research laboratories. The compliance with official regulations and the preparation of company internal radiation protection regulations are described. 1 tab., 9 refs

  16. Chromosome 10q tetrasomy: First reported case

    Energy Technology Data Exchange (ETDEWEB)

    Blackston, R.D.; May, K.M.; Jones, F.D. [Emory Univ., Atlanta, GA (United States)] [and others

    1994-09-01

    While there are several reports of trisomy 10q (at least 35), we are not aware of previous cases of 10q tetrasomy. We present what we believe to be the initial report of such a case. R.J. is a 6 1/2 year old white male who presented with multiple dysmorphic features, marked articulation problems, hyperactivity, and developmental delays. He is the product of a term uncomplicated pregnancy. There was a normal spontaneous vaginal delivery with a birth weight of 6 lbs. 4oz. and length was 19 1/2 inch. Dysmorphic features include small size, an asymmetrically small head, low set ears with overfolded helixes, bilateral ptosis, downslanting eyes, right eye esotropia, prominent nose, asymmetric facies, high palate, mild pectus excavatum deformity of chest, and hyperextensible elbow joints. The patient is in special needs classes for mildly mentally handicapped students. Chromosome analysis at a resolution of 800 bands revealed a complex rearrangement of chromosomes 10 and 11. The segment 10q25.3 to q16.3 appears to be inverted and duplicated within the long arm of chromosome 10 at band q25.3 and the same segment of chromosome 10 is present on the terminal end of the short arm of chromosome 11. There is no visible loss of material from chromosome 11. Fluorescence in situ hybridization was performed with a chromosome 10 specific {open_quotes}paint{close_quotes} to confirm that all of the material on the abnormal 10 and the material on the terminal short arm of 11 was from chromosome 10. Thus, it appears that the segment 10q25.3 to q26.3 is present in four copies. Parental chromosome studies are normal. We compared findings which differ in that the case of 10q tetrasomy did not have prenatal growth deficiency, microphthalmia, cleft palate, digital anomalies, heart, or renal defects. Whereas most cases of 10q trisomy are said to have severe mental deficiency, our case of 10q tetrasomy was only mildly delayed. We report this first apparent cited case of 10q tetrasomy.

  17. Coenzyme Q10 effects in neurodegenerative disease

    Directory of Open Access Journals (Sweden)

    Meredith Spindler

    2009-11-01

    Full Text Available Meredith Spindler1, M Flint Beal1,2, Claire Henchcliffe1,21Department of Neurology, 2Department of Neuroscience, Weill Medical College of Cornell University, New York, NY, USAAbstract: Coenzyme Q10 (CoQ10 is an essential cofactor in the mitochondrial respiratory chain, and as a dietary supplement it has recently gained attention for its potential role in the treatment of neurodegenerative disease. Evidence for mitochondrial dysfunction in neurodegenerative disorders derives from animal models, studies of mitochondria from patients, identification of genetic defects in patients with neurodegenerative disease, and measurements of markers of oxidative stress. Studies of in vitro models of neuronal toxicity and animal models of neurodegenerative disorders have demonstrated potential neuroprotective effects of CoQ10. With this data in mind, several clinical trials of CoQ10 have been performed in Parkinson’s disease and atypical Parkinson’s syndromes, Huntington’s disease, Alzheimer disease, Friedreich’s ataxia, and amyotrophic lateral sclerosis, with equivocal findings. CoQ10 is widely available in multiple formulations and is very well tolerated with minimal adverse effects, making it an attractive potential therapy. Phase III trials of high-dose CoQ10 in large sample sizes are needed to further ascertain the effects of CoQ10 in neurodegenerative diseases.Keywords: coenzyme Q10, neurodegenerative disease, Parkinson’s disease, Huntington’s disease, mitochondrial dysfunction

  18. The effects of advertising on sales in the pharmaceutical industry in ...

    African Journals Online (AJOL)

    Although advertising accounts for a major share of promotional expenditure of most companies in the pharmaceutical industry, most of them manifest considerable ignorance about how advertising works. This study aimed at determining the effect of advertising on the sales of pharmaceutical products bearing in mind the ...

  19. Balancing health and industrial policy objectives in the pharmaceutical sector: lessons from Australia.

    Science.gov (United States)

    Morgan, Steve; McMahon, Meghan; Greyson, Devon

    2008-08-01

    Policy-makers worldwide struggle to balance health with industrial policy objectives in the pharmaceutical sector. Tensions arise over pricing and reimbursement in particular. What health plans view as necessary to maintain equitable access to medicines, industry views as inimical to R&D and innovation. Australia has grappled with this issue for years, even incorporating the goal of "maintaining a responsible and viable medicines industry" into its National Medicines Policy. This case study was conducted via a narrative review that examined Australia's experiences balancing health and industrial policy objectives in the pharmaceutical sector. The review included electronic databases, grey literature and government publications for reports on relevant Australian policy published over the period 1985-2007. While pharmaceutical companies claim that Australia's pricing and reimbursement policies suppress drug prices and reduce profits, national policy audits indicate these claims are misguided. Australia appears to have secured relatively low prices for generics and "me-too drugs" while paying internationally competitive prices for "breakthrough" medicines. Simultaneously, Australia has focused efforts on local pharmaceutical investment through a variety of industry-targeted R&D incentive policies. Despite the fact that policy reviews suggest that Australia has achieved balance between health and industrial policy objectives, the country continues to face criticism from industry that its health goals harm innovation and R&D. Recent reforms raise the question whether Australia can sustain the apparent balance.

  20. Breeding of Coenzyme Q10 Produced Strain by Low-Energy Ion Implantation and Optimization of Coenzyme Q10 Fermentation

    International Nuclear Information System (INIS)

    Xu Dejun; Zheng Zhiming; Wang Peng; Wang Li; Yuan Hang; Yu Zengliang

    2008-01-01

    In order to increase the production efficiency of coenzyme Q 10 , the original strain Agrobacterium tumefaciens ATCC 4452 was mutated by means of Nitrogen ions implantation. A mutant strain, ATX 12, with high contents of coenzyme Q 10 was selected. Subsequently, the conditions such as carbohydrate concentration, nitrogen source concentration, inoculum's size, seed age, aeration and temperature which might affect the production of CoQ 10 were investigated in detail. Under optimal conditions, the maximum concentration of the intracellular CoQ 10 reached 200.3 mg/L after 80 h fed-batch fermentation, about 245% increasing in CoQ 10 production after ion implantation, compared to the original strain. (ion beam bioengineering)

  1. Coenzyme Q10 Supplementation in Aging and Disease

    Directory of Open Access Journals (Sweden)

    Juan D. Hernández-Camacho

    2018-02-01

    Full Text Available Coenzyme Q (CoQ is an essential component of the mitochondrial electron transport chain and an antioxidant in plasma membranes and lipoproteins. It is endogenously produced in all cells by a highly regulated pathway that involves a mitochondrial multiprotein complex. Defects in either the structural and/or regulatory components of CoQ complex or in non-CoQ biosynthetic mitochondrial proteins can result in a decrease in CoQ concentration and/or an increase in oxidative stress. Besides CoQ10 deficiency syndrome and aging, there are chronic diseases in which lower levels of CoQ10 are detected in tissues and organs providing the hypothesis that CoQ10 supplementation could alleviate aging symptoms and/or retard the onset of these diseases. Here, we review the current knowledge of CoQ10 biosynthesis and primary CoQ10 deficiency syndrome, and have collected published results from clinical trials based on CoQ10 supplementation. There is evidence that supplementation positively affects mitochondrial deficiency syndrome and the symptoms of aging based mainly on improvements in bioenergetics. Cardiovascular disease and inflammation are alleviated by the antioxidant effect of CoQ10. There is a need for further studies and clinical trials involving a greater number of participants undergoing longer treatments in order to assess the benefits of CoQ10 treatment in metabolic syndrome and diabetes, neurodegenerative disorders, kidney diseases, and human fertility.

  2. CURRENT TRENDS AND PROSPECTS OF THE RUSSIAN PHARMACEUTICAL INDUSTRY AND THE FOREIGN EXPERIENCE

    Directory of Open Access Journals (Sweden)

    Z. A. Mamedyarov

    2017-01-01

    Full Text Available Purpose: the purpose of this article is to study the current state of the pharmaceutical industry in Russia, to identify trends in Russian pharmaceutical market, and to provide preliminary analysis of the state support policy for pharmaceuticals in Russia, focusing on the federal target program "Pharma-2020".Methods: the study is based on a quantitative study of the characteristics and trends of the Russian pharmaceutical market. The emphasis was put on the period 2008–2017. The volume of the market, the structure of imports and exports are considered, and expenditures under the federal program "Pharma-2020" are studied. A qualitative comparative comparison with the tendencies of the global development of the industry is conducted and recommendations are made on further stimulating the growth of the pharma industry in Russia.Results: in the past 5 years, the pharmaceutical industry in Russia did receive special attention from the government, significant funds have been allocated for to support domestic producers, and import substitution policies have been launched. Financial results of the industry show slight improvement in a number of indicators: the market share of domestic medicines is growing, the generics production increased, production standards became tighter controlled. Nevertheless, Russia remains on the periphery of the world pharmaceutical science, import retains two thirds of the market share by value, while innovative novel drugs are now launched primarily by MNEs from the US and the EU.Conclusions and relevance: the challenges and development factors of Russia's pharmaceutical industry identified in this research require effective regulatory tools. First of all, it is necessary to reduce the gap between Russia and the developed countries in the R&D standards and their market implementation. Statistical data has showed the progress in the production of drugs from the VED list (Vital and Essential Drugs, but it is necessary to

  3. Medical students' exposure to and attitudes about the pharmaceutical industry: a systematic review.

    Directory of Open Access Journals (Sweden)

    Kirsten E Austad

    2011-05-01

    Full Text Available The relationship between health professionals and the pharmaceutical industry has become a source of controversy. Physicians' attitudes towards the industry can form early in their careers, but little is known about this key stage of development.We performed a systematic review reported according to PRISMA guidelines to determine the frequency and nature of medical students' exposure to the drug industry, as well as students' attitudes concerning pharmaceutical policy issues. We searched MEDLINE, EMBASE, Web of Science, and ERIC from the earliest available dates through May 2010, as well as bibliographies of selected studies. We sought original studies that reported quantitative or qualitative data about medical students' exposure to pharmaceutical marketing, their attitudes about marketing practices, relationships with industry, and related pharmaceutical policy issues. Studies were separated, where possible, into those that addressed preclinical versus clinical training, and were quality rated using a standard methodology. Thirty-two studies met inclusion criteria. We found that 40%-100% of medical students reported interacting with the pharmaceutical industry. A substantial proportion of students (13%-69% were reported as believing that gifts from industry influence prescribing. Eight studies reported a correlation between frequency of contact and favorable attitudes toward industry interactions. Students were more approving of gifts to physicians or medical students than to government officials. Certain attitudes appeared to change during medical school, though a time trend was not performed; for example, clinical students (53%-71% were more likely than preclinical students (29%-62% to report that promotional information helps educate about new drugs.Undergraduate medical education provides substantial contact with pharmaceutical marketing, and the extent of such contact is associated with positive attitudes about marketing and skepticism

  4. Effect of particle size on solubility, dissolution rate, and oral bioavailability: evaluation using coenzyme Q10 as naked nanocrystals

    Directory of Open Access Journals (Sweden)

    Sun J

    2012-11-01

    Full Text Available Jiao Sun,1 Fan Wang,1,2 Yue Sui,1 Zhennan She,1 Wenjun Zhai,1 Chunling Wang,1 Yihui Deng11College of Pharmacy, Shenyang Pharmaceutical University, Shenyang, China; 2Beijing Zhijianjinrui Applied Pharmaceutical Science Inc, Beijing, ChinaAbstract: In this paper work, four naked nanocrystals (size range 80–700 nm were prepared without any surfactant or polymer using the solvent/nonsolvent method. The effects of particle size on their solubility, dissolution, and oral bioavailability were investigated. Solubility and dissolution testing were performed in three types of dissolution medium, and the studies demonstrated that the equilibrium solubilities of coenzyme Q10 nanocrystals and bulk drugs were not affected by the dissolution media but the kinetic solubilities were. Kinetic solubility curves and changes in particle size distribution were determined and well explained by the proposed solubilization model for the nanocrystals and bulk drugs. The particle size effect on dissolution was clearly influenced by the diffusion coefficients of the various dissolution media, and the dissolution velocity of coenzyme Q10 increased as particle size decreased. The bioavailability of coenzyme Q10 after oral administration in beagle dogs was improved by reducing the particle size. For 700 nm nanocrystals, the AUC0–48 was 4.4-fold greater than that for the coarse suspensions, but a further decrease in particle size from 700 nm to 120 nm did not contribute to improvement in bioavailability until the particle size was reduced to 80 nm, when bioavailability was increased by 7.3-fold.Keywords: particle size, solubility, dissolution, nanocrystal, bioavailability, coenzyme Q10

  5. Ties that bind: multiple relationships between clinical researchers and the pharmaceutical industry.

    Science.gov (United States)

    Henry, David; Doran, Evan; Kerridge, Ian; Hill, Suzanne; McNeill, Paul M; Day, Richard

    2005-11-28

    It is believed that pharmaceutical industry sponsorship of clinical research leads to the development of multiple ties between clinicians and the pharmaceutical industry. To quantify this relationship we conducted a survey of medical specialists listed in the Medical Directory of Australia in 2002 and 2003. A questionnaire was mailed that elicited information about all aspects of research relationships between clinicians and pharmaceutical companies. The odds of reporting multiple additional ties (financial and professional) with pharmaceutical companies by clinicians who had an active research relationship were compared with those who did not. All clinicians who returned a completed questionnaire about their research activities were included in the study. A questionnaire was mailed to 2120 medical specialists; 823 (39%) responded. Of these, 338 (41%) reported involvement in industry-sponsored research in the previous year. They were more likely than others to have been offered industry-sponsored items or activities valued at more than 500 AU dollars (>382 US dollars; odds ratio [OR], 3.5; 95% confidence interval [CI], 2.6-4.7) and support for attending international conferences (OR, 5.4; 95% CI, 3.9-7.4). The strongest associations were seen for acting as a paid consultant to industry (OR, 9.0; 95% CI, 3.9-20.4) and for membership on advisory boards (OR, 6.9; 95% CI, 5.1-9.6). There was a strong relationship between research collaboration and accumulation of industry ties. For 1 additional tie the OR was 2.2 (95% CI, 1.2-3.8) and rose to 6.3 (95% CI, 3.5-11.1) with 3 ties and 41.8 (95% CI, 14.5-143.4) with 6 or more ties. Medical specialists who have research relationships with the pharmaceutical industry are much more likely to have multiple additional ties than those who do not have research relationships. Institutional review should discourage clinical researchers from developing multiple ties.

  6. Bioremediation Kinetics of Pharmaceutical Industrial Effluent

    Directory of Open Access Journals (Sweden)

    M. Šabić

    2015-05-01

    Full Text Available In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmented activated sludge with isolated mixed bacterial culture. The experiments were conducted in a batch reactor in submerged conditions, at initial concentration of organic matter in pharmaceutical wastewater, expressed as COD, 5.01 g dm–3 and different initial concentrations of activated sludge, which ranged from 1.16 to 3.54 g dm–3. During the experiments, the COD, pH, concentrations of dissolved oxygen and biomass were monitored. Microscopic analyses were performed to monitor the quality of activated sludge. Before starting with the bioremediation in the batch reactor, toxicity of the pharmaceutical wastewater was determined by toxicity test using bacteria Vibrio fischeri. The obtained results showed that the effective concentration of the pharmaceutical wastewater was EC50 = 17 % and toxicity impact index was TII50 = 5.9, meaning that the untreated pharmaceutical industrial effluent must not be discharged into the environment before treatment. The results of the pharmaceutical wastewater bioremediation process in the batch reactor are presented in Table 1. The ratio γXv ⁄ γX maintained high values throughout all experiments and ranged from 0.90 and 0.95, suggesting that the concentrations of biomass remained unchanged during the experiments. The important kinetic parameters required for performance of the biological removal process, namely μmax, Ks, Ki, Y and kd were calculated from batch experiments (Table 2. Figs. 1 and 2 show the experimental

  7. Quality management benchmarking: FDA compliance in pharmaceutical industry.

    Science.gov (United States)

    Jochem, Roland; Landgraf, Katja

    2010-01-01

    By analyzing and comparing industry and business best practice, processes can be optimized and become more successful mainly because efficiency and competitiveness increase. This paper aims to focus on some examples. Case studies are used to show knowledge exchange in the pharmaceutical industry. Best practice solutions were identified in two companies using a benchmarking method and five-stage model. Despite large administrations, there is much potential regarding business process organization. This project makes it possible for participants to fully understand their business processes. The benchmarking method gives an opportunity to critically analyze value chains (a string of companies or players working together to satisfy market demands for a special product). Knowledge exchange is interesting for companies that like to be global players. Benchmarking supports information exchange and improves competitive ability between different enterprises. Findings suggest that the five-stage model improves efficiency and effectiveness. Furthermore, the model increases the chances for reaching targets. The method gives security to partners that did not have benchmarking experience. The study identifies new quality management procedures. Process management and especially benchmarking is shown to support pharmaceutical industry improvements.

  8. Coenzyme Q10 protects hair cells against aminoglycoside.

    Directory of Open Access Journals (Sweden)

    Kazuma Sugahara

    Full Text Available It is well known that the production of free radicals is associated with sensory cell death induced by an aminoglycoside. Many researchers have reported that antioxidant reagents protect sensory cells in the inner ear, and coenzyme Q10 (CoQ10 is an antioxidant that is consumed as a health food in many countries. The purpose of this study was to investigate the role of CoQ10 in mammalian vestibular hair cell death induced by aminoglycoside. Cultured utricles of CBA/CaN mice were divided into three groups (control group, neomycin group, and neomycin + CoQ10 group. In the neomycin group, utricles were cultured with neomycin (1 mM to induce hair cell death. In the neomycin + CoQ10 group, utricles were cultured with neomycin and water-soluble CoQ10 (30-0.3 µM. Twenty-four hours after exposure to neomycin, the cultured tissues were fixed, and vestibular hair cells were labeled using an anti-calmodulin antibody. Significantly more hair cells survived in the neomycin + CoQ10 group than in the neomycin group. These data indicate that CoQ10 protects sensory hair cells against neomycin-induced death in the mammalian vestibular epithelium; therefore, CoQ10 may be useful as a protective drug in the inner ear.

  9. Looking at CER from the pharmaceutical industry perspective.

    Science.gov (United States)

    Dubois, Robert W

    2012-05-01

    Comparative effectiveness research (CER) is increasing as an element of health care reform in the United States. By comparing drugs against other drugs or other therapies instead of just to placebo, CER has the potential to improve decisions about the appropriate treatment for patients. But the growth of CER also brings an array of questions and decisions for purchasers and policy makers that will not be easy to answer and which require significant dialogue to fully understand and address. To describe some of the impact, both positive and negative, that comparative effectiveness research (CER) may have on the pharmaceutical industry. As CER data proliferate, questions are being raised about who can access the data, who can discuss it, and in what forums. Regulations place different communication restrictions on the pharmaceutical industry than on other health care stakeholders, which creates a potential inequality. Another CER consideration will be the tendency to apply average results to individuals, even if not every individual experiences the average result. Policy makers should implement CER findings carefully with a goal toward accommodating flexibility. A final impact to consider is whether greater expectations for CER will have a negative or positive effect on incentives for drug innovation. In some cases, CER may increase development costs or decrease market size. In other cases, better targeting of trial populations could result in lower development costs. The rising expectations and growth in CER raise questions about information access, communication restrictions, flexible implementation policies, and incentives for innovation. Members of the pharmaceutical industry should be cognizant of the questions and should be participating in dialogues now to pave the way for future solutions.

  10. Manufacturing capability as a technological development indicator in the pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    John Jairo Gallo Castro

    2010-01-01

    Full Text Available The pharmaceutical industrial has five subsectors: medicines, cosmetics, phytotherapeutics, cleaning products and medical devices. The medicine subsector consists of organisations producing, importing and selling these products. Most studies about this industry have been guided by economic interests without assessing technological aspects of production. This article was aimed at proposing a methodology for assessing and describing the medicine sector according to its technological development by using the manufacturing capability concept. The main information was taken from the Colombian Medicaments and Food Surveillance Institute’s (Instituto Nacional de Vigilancia de Medicamentos y Alimentos - INVIMA databases related to pharmaceutical plant production in Bogotá, including material transformation facilities. This study led to three characteristics being identified for defining the pharmaceutical industry’s manufacturing capability: that related to the pharmacological group to which active pharmaceutical ingredients belong, that linked to specifications regarding medicines’ sterility and that related to the technology required for manufacturing each pharmaceutical product. An analysis of these features has thus been presented and some technologies have been identified which have not been transferred or assimilated by the organisations being studied. It was found that manufacturing capability should be considered as being an indicator of the degree of technological development in these subsectors in Colombia.

  11. Transformation in the pharmaceutical industry--a systematic review of the literature.

    Science.gov (United States)

    Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J; Mouzughi, Yusra

    2013-01-01

    The evolutionary development of pharmaceutical transformation was studied through systematic review of the literature. Fourteen triggers were identified that will affect the pharmaceutical business, regulatory science, and enabling technologies in future years. The relative importance ranking of the transformation triggers was computed based on their prevalence within the articles studied. The four main triggers with the strongest literature evidence were Fully Integrated Pharma Network, Personalized Medicine, Translational Research, and Pervasive Computing. The theoretical quality risks for each of the four main transformation triggers are examined, and the remaining ten triggers are described. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities (this is termed pharmaceutical transformation). The impact of these changes on the approaches to quality risk management requires more understanding. In this paper, a comprehensive review of the academic, regulatory, and industry literature were used to identify 14 triggers that influence pharmaceutical transformation. The four main triggers, namely Fully Integrated Pharma Network, Personalized Medicine, Translational Research, and Pervasive Computing, were selected as the most important based on the strength of the evidence found during the literature review activity described in this paper. Theoretical quality risks for each of the four main transformation triggers are examined, and the remaining ten triggers are described.

  12. New strategies for innovation in global health: a pharmaceutical industry perspective.

    Science.gov (United States)

    Witty, Andrew

    2011-01-01

    Diseases that disproportionately affect developing countries play a large role in stalling economic and social development. Pharmaceutical companies are driving crucial research into new vaccines and medicines; however, although there is an imperative for industry to research new therapies for diseases of the poor, the financial returns are often seen as limited. This is beginning to change. The pharmaceutical industry and the public sector are thinking differently than before about how to improve access to medicines and advance research and development for neglected diseases. The public and private sectors must work together to develop a wide range of innovative tools, partnerships, and approaches.

  13. Transformational and Transactional Leadership Impact on Organizational Performance in Pharmaceutical Industry in Yemen

    Directory of Open Access Journals (Sweden)

    مراد محمد النشمي

    2017-12-01

    Full Text Available This study aimed at revealing the impact on transformational and transactional leadership in organizational performance of Pharmaceutical Industry in Yemen. The researchers have used descriptive analytical methods to answer the study questions and test the hypotheses. Questionnaire has been used for collecting quantitative data from the study sample which is a number of 227 middle and executive management in pharmaceutical companies. The study findings show that there is significant effect of all the dimensions of transformational and transactional leadership on organizational performance. Based on the regression analysis applied in the study, results indicated that transformational leadership is of the highest influencing variables on organizational performance. The study concluded that pharmaceutical companies adoption of modern leadership styles leads to distinguished performance. Keywords: Transformational leadership, Transactional leadership, Organizational performance, Pharmaceutical Industry.

  14. Pre-Clinical Medical Students' Exposure to and Attitudes Toward Pharmaceutical Industry Marketing.

    Science.gov (United States)

    Fein, Eric H; Vermillion, Michelle L; Uijtdehaage, Sebastian H J

    2007-12-01

    Background - Recent studies have examined the exposures and attitudes of physicians and third- and fourth-year medical students toward pharmaceutical industry marketing, but fewer studies have addressed these topics among pre-clinical medical students. Thus, the purpose of this study was to assess pre-clinical students' level of exposure to the pharmaceutical industry and their attitudes toward marketing. Method - First and second-year medical students at UCLA completed a 40-item survey based on previous studies. Results - Over three quarters of pre-clinical students (78.5% or 226 of 288) responded to the survey. Exposure to pharmaceutical industry marketing started very early in medical school. Most second-year students (77%) had received gifts including drug samples after three semesters. Most felt that this would not affect their future prescribing behavior. Conclusions - These findings and findings from related studies, coupled with the students' desire to learn more about the issue, suggest that an early educational intervention addressing this topic may be warranted in American medical schools.

  15. Sperm FISH analysis of a 44,X,der(Y),t(Y;15)(q12;q10)pat,rob(13;14)(q10;q10)mat complex chromosome rearrangement.

    Science.gov (United States)

    Ferfouri, F; Boitrelle, F; Clement, P; Molina Gomes, D; Selva, J; Vialard, F

    2014-06-01

    Complex chromosome rearrangements (CCR) with two independent chromosome rearrangements are rare. Although CCRs lead to high unbalanced gamete rates, data on meiotic segregation in this context are scarce. A male patient was referred to our clinic as part of a family screening programme prompted by the observation of a 44,X,der(Y),t(Y;15)(q12;q10)pat,rob(13;14)(q10;q10)mat karyotype in his brother. Karyotyping identified the same CCR. Sperm FISH (with locus-specific probes for the segments involved in the translocations and nine chromosomes not involved in both rearrangements) was used to investigate the rearrangements meiotic segregation products and establish whether or not an inter-chromosomal effect was present. Sperm nuclear DNA fragmentation was also evaluated. For rob(13;14) and der(Y), the proportions of unbalanced products were, respectively, 26.4% and 60.6%. Overall, 70.3% of the meiotic segregation products were unbalanced. No evidence of an inter-chromosomal effect was found, and the sperm nuclear DNA fragmentation rate was similar to our laboratory's normal cut-off value. In view of previously published sperm FISH analyses of Robertsonian translocations (and even though the mechanism is still unknown), we hypothesise that cosegregation of der(Y) and rob(13;14) could modify rob(13;14) meiotic segregation. © 2013 Blackwell Verlag GmbH.

  16. Public funding and private investment for R&D: a survey in China's pharmaceutical industry.

    Science.gov (United States)

    Qiu, Lan; Chen, Zi-Ya; Lu, Deng-Yu; Hu, Hao; Wang, Yi-Tao

    2014-06-13

    In recent years, China has experienced tremendous growth in its pharmaceutical industry. Both the Chinese government and private investors are motivated to invest into pharmaceutical research and development (R&D). However, studies regarding the different behaviors of public and private investment in pharmaceutical R&D are scarce. Therefore, this paper aims to investigate the current situation of public funding and private investment into Chinese pharmaceutical R&D. The primary data used in the research were obtained from the China High-tech Industry Statistics Yearbook (2002-2012) and China Statistical Yearbook of Science and Technology (2002-2012). We analyzed public funding and private investment in five aspects: total investment in the industry, funding sources of the whole industry, differences between provinces, difference in subsectors, and private equity/venture capital investment. The vast majority of R&D investment was from private sources. There is a significantly positive correlation between public funding and private investment in different provinces of China. However, public funding was likely to be invested into less developed provinces with abundant natural herbal resources. Compared with the chemical medicine subsector, traditional Chinese medicine and biopharmaceutical subsectors obtained more public funding. Further, the effect of the government was focused on private equity and venture capital investment although private fund is the mainstream of this type of investment. Public funding and private investment play different but complementary roles in pharmaceutical R&D in China. While being less than private investment, public funding shows its significance in R&D investment. With rapid growth of the industry, the pharmaceutical R&D investment in China is expected to increase steadily from both public and private sources.

  17. The reality behind the pharmaceutical industry, postmodernity with no mercy

    Directory of Open Access Journals (Sweden)

    Allan Rodríguez Artavia

    2014-04-01

    Full Text Available The following article analyzes the current need in the light of the principles of the (post modernity about the pharmaceutical industry. For its formulation, we conducted a literature review in the databases of the VirtualHealth Library (BIREME, and the Scientific Electronic Library Online (SciELO, where after applying predetermined inclusion criteria, it was possible to obtain a total of 23 items that served as the analysis base. Between the main results obtained in thirteen of the documents analyzed it criticizing the marketing process that has set as standard to follow in pharmaceutical production. In seven of the articles it is argued that by in pharmacological industry, there is limited access to medicines in countries or regions with less purchasing power, as there is reluctance to fund research related to diseases that are not profitable. It conclude that given currently own processes of neoliberal policies and capitalism that surround pharmaceutical production, lost focus on the health of the community, transforming such right in a process of marketing and commercialism.

  18. Understanding firm, physician and consumer choice behavior in the pharmaceutical industry

    NARCIS (Netherlands)

    Manchanda, P; Wittink, DR; Ching, A; Cleanthous, P; Ding, M; Dong, XJJ; Leeflang, PSH; Misra, S; Mizik, N; Narayanan, S; Steenburgh, T; Wieringa, JE; Wosinska, M; Xie, Y

    2005-01-01

    This paper argues that the pharmaceutical industry represents an exciting opportunity to carry out academic research. The nature of the industry allows researchers to answer new questions, develop new methodologies for answering these questions as well as to apply existing methodology to new data.

  19. Risk Management in the Pharmaceutical Industry in Slovenian Companies

    Directory of Open Access Journals (Sweden)

    Bucalo Nina

    2017-05-01

    Full Text Available The pharmaceutical industry is one of the most competitive businesses in the world. Supply chain in this industry has been directed towards the production of large batches to avoid lack of supplies, and the achievement of regulatory requirements, at the cost of high level of inventory, higher costs and inventory write-off due to expiration or other reasons. In recent years this industry is facing major changes and challenges such as intense globalization processes, increased competition and innovations in technologies, which has broadened and deepened risks in supply chain.

  20. [Innovation guidelines and strategies for pharmaceutical engineering of Chinese medicine and their industrial translation].

    Science.gov (United States)

    Cheng, Yi-Yu; Qu, Hai-Bin; Zhang, Bo-Li

    2013-01-01

    This paper briefly analyzes the bottlenecks and major technical requirements for pharmaceutical industry of Chinese medicine, providing current status of pharmaceutical engineering of Chinese medicine. The innovation directions and strategies of the pharmaceutical engineering for manufacturing Chinese medicine are proposed along with the framework of their core technology. As a consequence, the development of the third-generation pharmaceutical technology for Chinese medicine, featured as "precision, digital and intelligent", is recommended. The prospects of the pharmaceutical technology are also forecasted.

  1. Effekt og sikkerhed af kosttilskud indeholdende Q10

    DEFF Research Database (Denmark)

    Overvad, O.K; Diamant, B; Holm, L

    1997-01-01

    The literature concerning the importance of Q10 for health and disease has been reviewed. Dietary intake together with normal in vivo synthesisseems to fulfil the body's demands for Q10 in younger, healthy individuals. The importance of Q10 in general well-being has not been investigated incontro...

  2. INNOVATIVE AND INDUSTRIAL-PERFORMANCE IN PHARMACEUTICAL RESEARCH-AND-DEVELOPMENT, A MANAGEMENT CONTROL PERSPECTIVE

    NARCIS (Netherlands)

    OMTA, SWF; BOUTER, LM; VANENGELEN, JML

    In this paper management control is related to innovative and industrial performance in 14 non-biotech pharmaceutical companies. The study consisted of questionnaires, sent to the heads of the different research departments of European research laboratories of leading pharmaceutical companies,

  3. Managing the pharmaceutical industry-health system interface.

    Science.gov (United States)

    Zarowitz, B J; Muma, B; Coggan, P; Davis, G; Barkley, G L

    2001-12-01

    Direct-to-consumer advertising, media, and Internet marketing to physicians and patients, as well as enticing marketing strategies, are used by the pharmaceutical industry to ensure market share growth of new drugs. Our health system adopted a strict vendor policy governing detailing and sampling activities of pharmaceutical representatives, but realized that further analysis of vendor influence in our system was needed. An assessment of tangible benefits, ethical concerns, and financial liabilities and gains was conducted to reassess the need for further vendor restriction. Based on our findings, several recommendations have been made. Medical practices and health systems are encouraged to establish and enforce explicit vendor policies, measure their effectiveness, partner proactively with representatives to deliver a drug-detailing message consistent with system initiatives, monitor and regulate continuing medical education funding, and implement strategies to ensure appropriate drug use.

  4. Factors associated with the burnout syndrome among professionals in pharmaceutical manufacturing industry and marketing 1234

    Directory of Open Access Journals (Sweden)

    Jovanović Vesna R.

    2017-01-01

    Full Text Available Certain authors describe some professions in the healthcare industry as the more susceptible ones to developing a burnout syndrome, while others suggest psychosocial aspects of the workplace as the primary cause in its creation, but not the aspects of the job itself. The main objective of the research was to investigate which specific factors were associated with the burnout syndrome among professionals working in pharmaceutical manufacturing industry and marketing. The study was conducted in June of 2016 as a cross-sectional study and it included 75 university educated professionals from the area of pharmaceutical industry and marketing employed in several local as well as internationally renowned pharmaceutical companies located in Belgrade. The participants were surveyed anonymously. The instruments used in the study were: a general socio-demographic questionnaire, an assertiveness self-evaluation questionnaire and the Maslach Burnout Inventory. An analysis of the responses in the burnout syndrome self-evaluation questionnaires showed that the highest level of burnout was expressed through reduced personal accomplishment (53%. The average assertiveness scores were the lowest in the individuals who demonstrated the highest level of emotional exhaustion (p=0.003, depersonalization (p=0.004, and the highest inefficiency on professional accomplishment scale (p=0.001. A statistically significant difference was observed in frequency and extent of emotional exhaustion with respect to respondents' gender (x2=10.779; p<0.05, as well as the line of business (x2=6.493; p<0.05. Levels of depersonalization are influenced by: line of work (x2=5.393; p<0.05, age (p=0.004, total years of service (p=0.009 and years of service in the profession (p=0.006. A sense of reduced personal accomplishment is influenced by a respondents' profession (x2=10.922; p<0.05 and line of business (x2=7.283; p<0.05. The results obtained in this study might help in identifying

  5. [Coenzyme Q10 (Q-ter) in treatment of functional voice disorders].

    Science.gov (United States)

    Sensini, M; Corvino, A; Passeri, L; Gallone, G O; Landolfo, V; Raimondo, L; Giordano, C

    2011-01-01

    Aim of this study was to evaluate the effectivness of Coenzyme Q-Ter and Vitamin A in functional voice disorders. Twenty two patients were treated with CoQ10-ter and vitamin A twice a day for ten days. A general otolaryngological/foniatric and logopedic examination were performed. Videolaringostroboscopy, GIRBAS, Voice Handicap Index questionnaire and Multi-Dimensional Voice analysis were carried out before and after treatment. In all patients an improvement was observed in almost all parameters considered after treatment. CoQ10-ter and Vitamin A risulted effective in treatment of patients with functional voice disorders (caused by vocal "malmenage" or "surmenage").

  6. Customer relationship management in the contract pharmaceutical industry: an exploratory study for measuring success.

    Science.gov (United States)

    Kros, John F; Nadler, Scott; Molis, Justin

    2007-01-01

    Managing customer relationships is a very important issue in business-to-business markets. This research investigates the growing number of available resources defining Customer Relationship Management (CRM) efforts, and how they are being applied within the Contract Pharmaceutical Manufacturing industry. Exploratory study results using face-to-face and telephone questionnaires based on four criteria for rating a company's CRM efforts are presented. Data was collected from large Contract Pharmaceutical Manufacturing companies in the US market. The results and conclusions are discussed relating how the Contract Pharmaceutical Manufacturing industry is implementing CRM including some potential steps to take when considering a CRM initiative.

  7. How pharmaceutical industry employees manage competing commitments in the face of public criticism.

    Science.gov (United States)

    Lipworth, Wendy; Montgomery, Kathleen; Little, Miles

    2013-10-01

    The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the "medical affairs" departments of pharmaceutical companies, we conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance.

  8. [AIDS and social justice: pharmaceutical industry and economics].

    Science.gov (United States)

    López Guzmán, José

    2008-01-01

    This article takes a broad look at the complicated framework of relationships between the third world and pharmaceutical companies. In the first part of the work reference is made to the poverty of these countries, their lack of education in terms of health, the scarcity of basic hygiene, and their greatly limited access to medicines, especially those for treating AIDS. The article then proceeds to the issue of the pharmaceutical companies' degree of responsibility for the reduced availability of medicines in certain areas of the world. One of the factors that most limits access to medicines is their price, and many sectors of society propose taking action on the patents of drugs (rescinding or limiting them) in order to lower their price. However, the problem of patent exemption is more complicated than it seems at first glance, and comes with its own risks. If, for lack of funds or the uncertainty concerning a return on the capital invested, pharmaceutical companies discontinue research and development of new drugs, AIDS therapy would worsen. It is imperative and urgent to develop new drugs against the AIDS because of its resistance to the drugs currently available. The article concludes with the pharmaceutical industry's effort to look for possible forms of collaboration with developing countries.

  9. Total quality through computer integrated manufacturing in the pharmaceutical industry.

    Science.gov (United States)

    Ufret, C M

    1995-01-01

    The role of Computer Integrated Manufacturing (CIM) in the pursue of total quality in pharmaceutical manufacturing is assessed. CIM key objectives, design criteria, and performance measurements, in addition to its scope and implementation in a hierarchical structure, are explored in detail. Key elements for the success of each phase in a CIM project and a brief status of current CIM implementations in the pharmaceutical industry are presented. The role of World Class Manufacturing performance standards and other key issues to achieve full CIM benefits are also addressed.

  10. Towards the design of a zero effluent facility in the pharmaceutical industry

    CSIR Research Space (South Africa)

    Gouws, JF

    2007-05-01

    Full Text Available . The pharmaceutical production industry has some unique characteristics that make it possible to reach the goal of zero effluent. In such industries wastewater is generally produced from washing out of mixing vessels. The wastewater thus contains valuable product...

  11. The future of risk communication and the role of the pharmaceutical industry.

    Science.gov (United States)

    Chakraborty, Sweta; Bouder, Frederic

    2013-02-01

    Risk communication is an interactive two-way process that various stakeholders (e.g., patients, regulators, industry) utilize to address prescription drug safety. This paper will specifically examine the pharmaceutical industry's engagement with risk communication as a tool for information exchange with patients and other stakeholders about the associated risks related to its medicines. Risk communications are not solely meant to inform; and rather effective two-way risk communications have the potential to change behavioral outcomes for the purpose of individual and societal benefit. Despite this indispensable role of risk communication for the pharmaceutical industry, more research is needed for the appropriate development and dissemination of risk communications. A crucial missing component for the crafting of pharmaceutical risk communications is the understanding of risk perceptions from the patient/consumer's perspective. This is necessary to see where any divergences in views may lie between the industry and its final consumer, which is crucial in tailoring communications to target a specific erroneous belief or to address what might be deemed as a needed behavioral shift. It is also necessary to develop communications in consideration of the levels of public trust in the industry as well as other perceived actors in the healthcare system. Even the most meticulously crafted and tested risk communications will fail to fulfill their purpose if the role of trust is not taken into consideration. These considerations can lead to the establishment of a "social contract" that effectively addresses what is required from both parties for continued and mutually beneficial interactions. Conducting risk perception research, addressing the role of trust, establishing a social contract, and having a realistic outlook on the impact of risk communications are necessary considerations as pharmaceutical risk communication evolves for the future.

  12. The Influence of Emerging Markets on the Pharmaceutical Industry.

    Science.gov (United States)

    Tannoury, Maya; Attieh, Zouhair

    2017-01-01

    Emerging markets represent an exceptional opportunity for the pharmaceutical industry. Although a precise definition is not yet available, economists define emerging markets as developing prosperous countries in which investment is expected to result in higher income despite high risks. Qualifying a market as emerging is not merely based on the economic status of the country, but also on several criteria that render the definition applicable to each country. Jim O'Neil, retired chairman of asset management at Goldman Sachs, identified leading economies of emerging markets: Brazil, Russia, India, and China (BRIC) and later Brazil, Russia, India, China, and South Africa (BRICS) and then Mexico, Indonesia, South Korea, and Turkey (MIST), which followed years later as the second tier of nations. Sales of the pharmaceutical markets in BRICS and MIST countries doubled in 5 years, reaching a market share of approximately 20%. The shift toward these new markets has been attributed to the large populations, growing prosperity, and increasing life expectancy in BRICS and MIST countries. In addition, companies are experiencing flattened growth of developed markets, expiration of patents leading to the up-selling of less expensive generic drugs, and tight regulations enforced in mature markets. Particular attention must therefore be given to these emerging markets. The strategies adopted by pharmaceutical companies that want to expand in these markets must be tailored to the pace of development of each country. These countries need drugs against infectious diseases and communicable diseases such as sexually transmitted diseases. They are readily exploitable territories for the innovative products of pharmaceuticals. Nevertheless, with the increase in wealth and longevity, a change of lifestyle is occurring. These changes accompany a shift in disease patterns. A disproportionally fast rise in the incidence of noncommunicable diseases such as cardiovascular illnesses, diabetes

  13. Public funding and private investment for R&D: a survey in China’s pharmaceutical industry

    Science.gov (United States)

    2014-01-01

    Background In recent years, China has experienced tremendous growth in its pharmaceutical industry. Both the Chinese government and private investors are motivated to invest into pharmaceutical research and development (R&D). However, studies regarding the different behaviors of public and private investment in pharmaceutical R&D are scarce. Therefore, this paper aims to investigate the current situation of public funding and private investment into Chinese pharmaceutical R&D. Methods The primary data used in the research were obtained from the China High-tech Industry Statistics Yearbook (2002–2012) and China Statistical Yearbook of Science and Technology (2002–2012). We analyzed public funding and private investment in five aspects: total investment in the industry, funding sources of the whole industry, differences between provinces, difference in subsectors, and private equity/venture capital investment. Results The vast majority of R&D investment was from private sources. There is a significantly positive correlation between public funding and private investment in different provinces of China. However, public funding was likely to be invested into less developed provinces with abundant natural herbal resources. Compared with the chemical medicine subsector, traditional Chinese medicine and biopharmaceutical subsectors obtained more public funding. Further, the effect of the government was focused on private equity and venture capital investment although private fund is the mainstream of this type of investment. Conclusions Public funding and private investment play different but complementary roles in pharmaceutical R&D in China. While being less than private investment, public funding shows its significance in R&D investment. With rapid growth of the industry, the pharmaceutical R&D investment in China is expected to increase steadily from both public and private sources. PMID:24925505

  14. Attitudes and relationship between physicians and the pharmaceutical industry in a public general hospital in Lima, Peru.

    Directory of Open Access Journals (Sweden)

    Aldo De Ferrari

    Full Text Available BACKGROUND: The interaction between physicians and the pharmaceutical industry influences physicians' attitudes and prescribing behavior. Although largely studied in the US, this topic has not been well studied in resource-poor settings, where a close relationship between physicians and industry still exists. OBJECTIVE: To describe physician interactions with and attitudes towards the pharmaceutical industry in a public general hospital in Lima, Peru. DESIGN: Descriptive, cross-sectional study through an anonymous, self-filled questionnaire distributed among faculty and trainee physicians of five different clinical departments working in a Peruvian public general hospital. A transcultural validation of an existing Spanish questionnaire was performed. Exposure to marketing activities, motivations to contact pharmaceutical representatives and attitudes towards industry were studied. Collected data was analyzed by degree of training, clinical department, gender and teaching status. Attitudes were measured on a four-point LIKERT scale. RESULTS: 155 physicians completed the survey, of which 148 were included in the study sample. 94.5% of attending physicians reported ongoing encounters with pharmaceutical representatives. The most common industry-related activities were receiving medical samples (91.2%, promotional material (87.8% and attending meetings in restaurants (81.8%. Respondents considered medical samples and continuing medical education the most ethically acceptable benefits. We found significant differences between attendings and residents, and teaching and non-teaching attendings. An association between the amount of encounters with pharmaceutical representatives, and attitudes towards industry and acceptance of medical samples was found. CONCLUSIONS: A close physician-industry relationship exists in the population under study. The contact is established mainly through pharmaceutical representatives. Medical samples are the most received

  15. Role of coenzyme Q10 (CoQ10) in cardiac disease, hypertension and Meniere-like syndrome.

    Science.gov (United States)

    Kumar, Adarsh; Kaur, Harharpreet; Devi, Pushpa; Mohan, Varun

    2009-12-01

    Coenzyme Q10 (ubiquinone) is a mitochondrial coenzyme which is essential for the production of ATP. Being at the core of cellular energy processes it assumes importance in cells with high energy requirements like the cardiac cells which are extremely sensitive to CoQ10 deficiency produced by cardiac diseases. CoQ10 has thus a potential role for prevention and treatment of heart ailments by improving cellular bioenergetics. In addition it has an antioxidant, a free radical scavenging and a vasodilator effect which may be helpful in these conditions. It inhibits LDL oxidation and thus the progression of atherosclerosis. It decreases proinflammatory cytokines and decreases blood viscosity which is helpful in patients of heart failure and coronary artery disease. It also improves ischemia and reperfusion injury of coronary revascularisation. Significant improvement has been observed in clinical and hemodynamic parameters and in exercise tolerance in patients given adjunctive CoQ10 in doses from 60 to 200 mg daily in the various trials conducted in patients of heart failure, hypertension, ischemic heart disease and other cardiac illnesses. Recently it has been found to be an independent predictor of mortality in congestive heart failure. It has also been found to be helpful in vertigo and Meniere-like syndrome by improving the immune system. Further research is going on to establish firmly its role in the therapy of cardiovascular diseases.

  16. The uncertainty budget in pharmaceutical industry

    DEFF Research Database (Denmark)

    Heydorn, Kaj

    of their uncertainty, exactly as described in GUM [2]. Pharmaceutical industry has therefore over the last 5 years shown increasing interest in accreditation according to ISO 17025 [3], and today uncertainty budgets are being developed for all so-called critical measurements. The uncertainty of results obtained...... that the uncertainty of a particular result is independent of the method used for its estimation. Several examples of uncertainty budgets for critical parameters based on the bottom-up procedure will be discussed, and it will be shown how the top-down method is used as a means of verifying uncertainty budgets, based...

  17. Building legitimacy by criticising the pharmaceutical industry: a qualitative study among prescribers and local opinion leaders.

    Science.gov (United States)

    Pittet, Anne-Laure; Saraga, Michael; Stiefel, Friedrich

    2015-01-01

    The literature has described opinion leaders not only as marketing tools of the pharmaceutical industry, but also as educators promoting good clinical practice. This qualitative study addresses the distinction between the opinion-leader-as-marketing-tool and the opinion-leader-as-educator, as it is revealed in the discourses of physicians and experts, focusing on the prescription of antidepressants. We explore the relational dynamic between physicians, opinion leaders and the pharmaceutical industry in an area of French-speaking Switzerland. Qualitative content analysis of 24 semistructured interviews with physicians and local experts in psychopharmacology, complemented by direct observation of educational events led by the experts, which were all sponsored by various pharmaceutical companies. Both physicians and experts were critical of the pharmaceutical industry and its use of opinion leaders. Local experts, in contrast, were perceived by the physicians as critical of the industry and, therefore, as a legitimate source of information. Local experts did not consider themselves opinion leaders and argued that they remained intellectually independent from the industry. Field observations confirmed that local experts criticised the industry at continuing medical education events. Local experts were vocal critics of the industry, which nevertheless sponsor their continuing education. This critical attitude enhanced their credibility in the eyes of the prescribing physicians. We discuss how the experts, despite their critical attitude, might still be beneficial to the industry's interests.

  18. Relatives with opposite chromosome constitutions, rec(10)dup(10p)inv(10)(p15.1q26.12) and rec(10)dup(10q)inv(10)(p15.1q26.12), due to a familial pericentric inversion.

    Science.gov (United States)

    Ciuladaite, Zivile; Preiksaitiene, Egle; Utkus, Algirdas; Kučinskas, Vaidutis

    2014-01-01

    Large pericentric inversions in chromosome 10 are rare chromosomal aberrations with only few cases of familial inheritance. Such chromosomal rearrangements may lead to production of unbalanced gametes. As a result of a recombination event in the inversion loop, 2 recombinants with duplicated and deficient chromosome segments, including the regions distal to the inversion, may be produced. We report on 2 relatives in a family with opposite terminal chromosomal rearrangements of chromosome 10, i.e. rec(10)dup(10p)inv(10) and rec(10)dup(10q)inv(10), due to familial pericentric inversion inv(10)(p15.1q26.12). Based on array-CGH results, we characterized the exact genomic regions involved and compared the clinical features of both patients with previous reports on similar pericentric inversions and regional differences within 10p and 10q. The fact that both products of recombination are viable indicates a potentially high recurrence risk of unbalanced offspring. This report of unbalanced rearrangements in chromosome 10 in 2 generations confirms the importance of screening for terminal imbalances in patients with idiopathic intellectual disability by molecular cytogenetic techniques such as FISH, MLPA or microarrays. It also underlines the necessity for FISH to define structural characteristics of such cryptic intrachromosomal rearrangements and the underlying cytogenetic mechanisms. © 2014 S. Karger AG, Basel.

  19. Polish physicians' cooperation with the pharmaceutical industry and its potential impact on public health.

    Directory of Open Access Journals (Sweden)

    Marta Makowska

    Full Text Available This article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health.It considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians' website (Medycyna Praktyczna between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland.The majority of respondents (96.8% said that they had talked with pharmaceutical sales representatives (PSRs in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3% said they trusted the information provided by PSRs. Over one third of respondents (36.4% claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law.The study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency and strengthen the ethical

  20. Polish physicians' cooperation with the pharmaceutical industry and its potential impact on public health.

    Science.gov (United States)

    Makowska, Marta

    2017-01-01

    This article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health. It considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians' website (Medycyna Praktyczna) between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland. The majority of respondents (96.8%) said that they had talked with pharmaceutical sales representatives (PSRs) in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3%) said they trusted the information provided by PSRs. Over one third of respondents (36.4%) claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law. The study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency and strengthen the ethical guidelines

  1. Polish physicians’ cooperation with the pharmaceutical industry and its potential impact on public health

    Science.gov (United States)

    2017-01-01

    Objective This article aims to describe how Polish physicians cooperate with the pharmaceutical industry and show how this relationship may pose a threat to public health. Methods It considers the results of an online survey of 379 physicians. The survey was hosted by surveymonkey.com with links from a Polish physicians’ website (Medycyna Praktyczna) between 29 October 2013 and 31 December 2013. The sample was purposive, respondents having to be physicians working in Poland. Results The majority of respondents (96.8%) said that they had talked with pharmaceutical sales representatives (PSRs) in their practice, with 85% saying that they had had regular contact with them. Despite the existing legal ban in Poland, 35% of respondents admitted that they had usually met with PSRs in their office during working hours. As many as 81.8% of surveyed doctors said that they had taken part in an educational meeting organized by the pharmaceutical industry at least once during the 12 months preceding the study. A majority of the respondents (72.3%) said they trusted the information provided by PSRs. Over one third of respondents (36.4%) claimed that Polish doctors accepted gifts of a type that they should not accept according to Polish law. Conclusions The study showed that Polish physicians cooperate in different ways with pharmaceutical companies and have frequent contact with them. This can influence their knowledge and doctors whose knowledge of drugs is based mainly on information from pharmaceutical industry materials may prescribe medicines in a biased way, possibly exposing their patients to sub-optimal treatments and burdening both their patients and the state budget with unnecessary costs. Lack of trust in doctors and pharmaceutical companies have other implications too: there may be a decline of faith in the efficacy of therapy and patients may be encouraged to engage in self-diagnosis and self-treatment. For these reasons it is necessary to increase transparency

  2. Discovery of innovative therapeutics: today's realities and tomorrow's vision. 1. Criticisms faced by the pharmaceutical industry.

    Science.gov (United States)

    Abou-Gharbia, Magid; Childers, Wayne E

    2013-07-25

    The pharmaceutical industry is facing enormous challenges, including reduced efficiency, declining innovation, key patent expirations, fierce price competition from generics, high regulatory hurdles, and a tarnished image. There is a clear need for change in the paradigms designed to address these challenges. Pharma has responded by embarking on a range of initiatives. However, along the way the industry has accrued critics whose accusations have tainted its reputation. The first part of this two-part series will discuss the criticisms that have been leveled at the pharmaceutical industry and summarize the supporting data for and against these criticisms. The second installment will focus on the current challenges facing the pharmaceutical industry and Pharma's responses to address these challenges. It will describe the industry's changing perspective and new business models for coping with the recent loss of talent and declining clinical pipelines as well as present some examples of recent drug discovery successes.

  3. Biotechnological applications of functional metagenomics in the food and pharmaceutical industries.

    Science.gov (United States)

    Coughlan, Laura M; Cotter, Paul D; Hill, Colin; Alvarez-Ordóñez, Avelino

    2015-01-01

    Microorganisms are found throughout nature, thriving in a vast range of environmental conditions. The majority of them are unculturable or difficult to culture by traditional methods. Metagenomics enables the study of all microorganisms, regardless of whether they can be cultured or not, through the analysis of genomic data obtained directly from an environmental sample, providing knowledge of the species present, and allowing the extraction of information regarding the functionality of microbial communities in their natural habitat. Function-based screenings, following the cloning and expression of metagenomic DNA in a heterologous host, can be applied to the discovery of novel proteins of industrial interest encoded by the genes of previously inaccessible microorganisms. Functional metagenomics has considerable potential in the food and pharmaceutical industries, where it can, for instance, aid (i) the identification of enzymes with desirable technological properties, capable of catalyzing novel reactions or replacing existing chemically synthesized catalysts which may be difficult or expensive to produce, and able to work under a wide range of environmental conditions encountered in food and pharmaceutical processing cycles including extreme conditions of temperature, pH, osmolarity, etc; (ii) the discovery of novel bioactives including antimicrobials active against microorganisms of concern both in food and medical settings; (iii) the investigation of industrial and societal issues such as antibiotic resistance development. This review article summarizes the state-of-the-art functional metagenomic methods available and discusses the potential of functional metagenomic approaches to mine as yet unexplored environments to discover novel genes with biotechnological application in the food and pharmaceutical industries.

  4. Biotechnological applications of functional metagenomics in the food and pharmaceutical industries

    Directory of Open Access Journals (Sweden)

    Laura M Coughlan

    2015-06-01

    Full Text Available Microorganisms are found throughout nature, thriving in a vast range of environmental conditions. The majority of them are unculturable or difficult to culture by traditional methods. Metagenomics enables the study of all microorganisms, regardless of whether they can be cultured or not, through the analysis of genomic data obtained directly from an environmental sample, providing knowledge of the species present and allowing the extraction of information regarding the functionality of microbial communities in their natural habitat. Function-based screenings, following the cloning and expression of metagenomic DNA in a heterologous host, can be applied to the discovery of novel proteins of industrial interest encoded by the genes of previously inaccessible microorganisms. Functional metagenomics has considerable potential in the food and pharmaceutical industries, where it can, for instance, aid (i the identification of enzymes with desirable technological properties, capable of catalysing novel reactions or replacing existing chemically synthesized catalysts which may be difficult or expensive to produce, and able to work under a wide range of environmental conditions encountered in food and pharmaceutical processing cycles including extreme conditions of temperature, pH, osmolarity, etc; (ii the discovery of novel bioactives including antimicrobials active against microorganisms of concern both in food and medical settings; (iii the investigation of industrial and societal issues such as antibiotic resistance development. This review article summarizes the state-of-the-art functional metagenomic methods available and discusses the potential of functional metagenomic approaches to mine as yet unexplored environments to discover novel genes with biotechnological application in the food and pharmaceutical industries.

  5. Micro factors bringing the pharmaceutical industry to a seismic shaking a qualitative research.

    Science.gov (United States)

    Dierks, Raphaela Marie Louisa; Bruyère, Olivier; Reginster, Jean-Yves

    2017-06-01

    Due to changing macro and micro factors, expiring patents and falling net income, pharmaceutical companies need to rethink their vertical business model. The trend shows cross-sectorial partnerships and consolidation to remain and compete on the market. Areas covered: Quantitative research interviewing a target group of 25 key executives from small, mid and large global pharmaceutical companies rounded with qualitative literature research completing the analysis. Expert commentary: Uncertainty in the industry due to changing external factors i.e. pricing pressures, regulations or an economic slowdown, slowing down innovations and new drug outcomes. Pharmaceutical companies understand the existing hurdles, and are critically optimistic implementing new business models. Also, various stakeholders are included in the value chain due to their growing importance. During the next years, the industry will be restructured from volume towards value, and only pharmaceutical companies' clairaudient and reciprocate to the changes with an out-off the box thinking will be able to resist on the market. Small biotech companies should focus on research, and big pharmaceutical companies entering at development focusing on the process until the distribution. This execution business recommendation would enable the best know-how at the right point, mitigating the risk and enhancing the patient outcomes.

  6. Structural-functional and parametric analysis of the social function of pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    N. O. Tkachenko

    2016-12-01

    Full Text Available Pharmacy has always had a special (social value and was sensitive to the new social changes in the society and the state. These changes allow better understand the issues associated with increasing the efficiency of pharmaceutical care to the population. The aim of the work: identify, justify and to summarize the main elements of the social function of pharmacy, as a component of health care system, to further evaluate the properties of the pharmaceutical industry as a system. Materials and methods. To achieve this goal the principle of a systematic approach and the complex of research methods such as structural, functional and parametric analysis, logical knowledge and comparison, ad also generalization have been used. As materials of research, we used the results of fundamental and applied research of national and foreign experts on the issue. Results and discussion. The basic principles of the welfare state and pharmacy as socially oriented sectors of the economy have been determined. We have found that the pharmaceutical industry is an agent, which implements a number of elements of the social function, such as pharmaceutical assistance to the population, the production of social goods (drugs, medical products, medical cosmetics, etc., creating and providing of working places, paying taxes (replenishment of the state budget, the formation and development of human capital, research and innovation activities, charity and sponsorship, environmental protection. Ukraine formally acceded to United Nations document, «Agenda for the XXI Century». This agreement commits our government to implement development and implementation of sustainable development strategies. Its main components are the social responsibility, social integration, an efficient worker and effective owner. Social responsibility acts as a reverse reaction on realization of social policy through the main sectors of the economy. Conclusions. We have summarized the information and

  7. Monopolistic structures and industrial analysis in Spain: the case of the pharmaceutical industry.

    Science.gov (United States)

    Lobo, F

    1979-01-01

    This article seeks to illustrate the monopolistic structure of the Spanish pharmaceutical industry, focusing on its many dimensions. The basic conditions of technology and demand, product differentiation, effect of advertising, and barriers to entry are considered, as is financial and economic concentration. Although economic conditions are emphasized, the ways they affect public and private health, the quality of health services, and health education are also highlighted.

  8. The Direct and Indirect Impact of Pharmaceutical Industry in Economic Expansion and Job Creation: Evidence from Bootstrapping and Normal Theory Methods

    Directory of Open Access Journals (Sweden)

    Rizwan Raheem Ahmed

    2018-05-01

    Full Text Available The objective of this research article is to examine the role of Pakistan’s pharmaceutical industry in job creation opportunities, with the sacred intention to eradicate poverty, and expansion in economic activities. This research is quantitative in nature, and the data is directly gathered through closed-ended questionnaires from 300 respondents. Besides predictors’, four mediating variables have also been taken into consideration that contribute indirectly in job creation opportunities. Bootstrapping and Normal theory methods have been employed in order to examine the impact of predictors’ and mediating variables. The result of this research confirmed that pharmaceutical industry plays a vital role in job creation in Pakistan. It is further concluded that the pharmaceutical industry has a direct and significant impact in job creation by providing indigenous and direct job opportunities in sales, marketing, and other supporting departments for both skilled and unskilled workers. Pharmaceutical industry also provides indirect job opportunities through other industries, which are very much linked with this industry, such as: pharmaceutical distributors, dealers, retailers, wholesalers, hotel industry, and event management industry. It is also determined that pharmaceutical industry is acting like knowledge and skills imparting institutions. Therefore, skilled-based training and organizational learning are major mediating variables that transform unskilled people into human assets, which further trigger the future job prospects. Since pharmaceutical industry is one of the biggest industries in Pakistan, providing plenteous opportunities of new jobs with consistent growth. Thus, mediating variables such as motivation and interpersonal influence also preceded an active role in new job creation

  9. Pharmaceutical industry's corporate social responsibility towards HIV/AIDS.

    Science.gov (United States)

    Khanna, Arun Kumar

    2006-01-01

    The pharmaceutical industry has a corporate social responsibility (CSR) towards HIV/AIDS. Measures taken to increase awareness of HIV/AIDS, availability and accessibility of potent and patient-friendly FDCs / Kits for adults and children will go a long way in increasing awareness and acceptance of this disease and its therapy. This will improve adherence, lower resistance and facilitate better disease management. This article discusses some of the CSR initiatives and their scope.

  10. Financial Aspects and the Future of the Pharmaceutical Industry in the United States of America

    OpenAIRE

    Karamehic, Jasenko; Ridic, Ognjen; Ridic, Goran; Jukic, Tomislav; Coric, Jozo; Subasic, Djemo; Panjeta, Mirsad; Saban, Aida; Zunic, Lejla; Masic, Izet

    2013-01-01

    Introduction: The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as “companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use”. Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers’ lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one ...

  11. Proceed to the innovation in the pharmaceutical industry. The case of Spain

    Directory of Open Access Journals (Sweden)

    Aída Salazar García

    2015-01-01

    Full Text Available This article explores sectors identified innovation in Spanish pharmaceutical companies. It also considers domestic firms and foreign subsidiaries in the country. The analysis covers the period 2009 to 2011 for a population N=200 affiliates at that time Farmaindustria and Plan Profarma. The work involved a search of useful information on the websites of pharmaceutical companies based in Spain statically describes the innovative profile of the Spanish pharmaceutical through descriptive statistical analysis. Thus a foundation for documenting the results in a database in order to get a picture with determination on the behavior of Spanish pharmaceutical sector and possible trends is created.The high content of literary contribution on the pharmaceutical sector is expressed in a globalized national and international level, rejecting data and information that could provide signals threat or opportunity regarding short period time, and which in turn are comparable to other years since the Spanish pharmaceutical industry is constituted by companies of foreign origin (50.5% and domestic capital (49.5%. Of the latter SMEs are the protagonists of small innovations established in Madrid and Barcelona mainly.

  12. FORMATION AND FURTHER DEVELOPMENT OF MODERN PROMOTION OF PHARMACEUTICAL PRODUCTS

    Directory of Open Access Journals (Sweden)

    Юрий Владимирович Тарасов

    2014-02-01

    Full Text Available The articles addresses key notions and elements of marketing of pharmaceutical companies. Key stages and particularities of formation of pharmaceutical marketing are considered. It is proved that in general pharmaceutical market is developing under general marketing rules, however while developing strategy of promotion of pharmaceutical products specific features of the industry must be taken into consideration. The authors describes specific features of modern pharmaceutical market, which must be considered while developing policy of promotion of pharmaceutical products.The analysis is made of modern state of Russian pharmaceutical industry, its place in world pharmaceutical market. It is found that development of pharmaceutical market is directly influenced by the reform of pharmaceutical industry initiated by the Government of our country in 2008. Characteristic of current stage of market development is more strict conditions in marketing sphere and promotion of drugs. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-2

  13. Missionary Ethics in Q 10:2−12

    Directory of Open Access Journals (Sweden)

    Dieter T. Roth

    2012-06-01

    Full Text Available Elements of the mission discourse of the Synoptic Gospels are found in Mark 6:6b−13; Matthew 9:35−10:15; Luke 9:1−6 and Luke 10:1−20. Similarities and differences in these accounts have led many New Testament scholars to posit the presence of a mission discourse in Q. This discourse, along with the parable that introduces it (Q 10:2, provides insight into how Q conceives of ‘mission’ as well as the ethical principles and precepts that are part of Jesus’ missional charge in this document. Through an intertextual approach to Q, with particular emphasis on narrative structure and imagery, this paper considered the interplay of mission and ethics in this early Christian text.

  14. Micronutrient special issue: Coenzyme Q10 requirements for DNA damage prevention

    International Nuclear Information System (INIS)

    Schmelzer, Constance; Döring, Frank

    2012-01-01

    Coenzyme Q 10 (CoQ 10 ) is an essential component for electron transport in the mitochondrial respiratory chain and serves as cofactor in several biological processes. The reduced form of CoQ 10 (ubiquinol, Q 10 H 2 ) is an effective antioxidant in biological membranes. During the last years, particular interest has been grown on molecular effects of CoQ 10 supplementation on mechanisms related to DNA damage prevention. This review describes recent advances in our understanding about the impact of CoQ 10 on genomic stability in cells, animals and humans. With regard to several in vitro and in vivo studies, CoQ 10 provides protective effects on several markers of oxidative DNA damage and genomic stability. In comparison to the number of studies reporting preventive effects of CoQ 10 on oxidative stress biomarkers, CoQ 10 intervention studies in humans with a direct focus on markers of DNA damage are limited. Thus, more well-designed studies in healthy and disease populations with long-term follow up results are needed to substantiate the reported beneficial effects of CoQ 10 on prevention of DNA damage.

  15. A vision of the pharmaceutical industry.

    Science.gov (United States)

    Muñio, S

    1998-01-01

    As the financial resources available for looking after the health of an aging population are limited, generic drugs (drugs that are no longer covered by a patent and marketed at a lower price) have come to be used in western countries as a means for meeting growing demand while leaving resources in the health budget for new drugs. In Spain, a law on product patents was introduced in 1992, which is much later than in other countries, and created difficulties in the definition and procedure for gaining approval for generic drugs. Circular 3/97 from the Ministry of Health finally resolved these issues. In this circular, generic pharmaceutical products (GPPs) are clearly defined and identified with a positive commitment towards guaranteeing the ability to interchange original drugs for other cheaper generic products and towards clarifying the Spanish vade mecum. The position of the pharmaceutical industry on generic drugs varies widely and consequently, it is impossible to make a general statement on the view of the industry. However, the commitment of Novartis, given the issues described above and in line with the company's global strategy, is to offer innovation and services to society. This is perfectly compatible with offering health professionals both innovative drugs and generic drugs of a high quality at a lower price, given that registering genetics requires less investment in research and development. In any case, GPPs face an uncertain future in Spain and market forecasts also differ widely, ranging from 15 billion to 80 billion pesetas in the year 2000. It will be necessary to get doctors and pharmacists positively involved, to set up fast structural measures, and to avoid rejection by patients through successful information and marketing.

  16. Homochiral drugs: a demanding tendency of the pharmaceutical industry.

    Science.gov (United States)

    Núñez, María C; García-Rubiño, M Eugenia; Conejo-García, Ana; Cruz-López, Olga; Kimatrai, María; Gallo, Miguel A; Espinosa, Antonio; Campos, Joaquín M

    2009-01-01

    The issue of drug chirality is now a major theme in the design and development of new drugs, underpinned by a new understanding of the role of molecular recognition in many pharmacologically relevant events. In general, three methods are utilized for the production of a chiral drug: the chiral pool, separation of racemates, and asymmetric synthesis. Although the use of chiral drugs predates modern medicine, only since the 1980's has there been a significant increase in the development of chiral pharmaceutical drugs. An important commercial reason is that as patents on racemic drugs expire, pharmaceutical companies have the opportunity to extend patent coverage through development of the chiral switch enantiomers with desired bioactivity. Stimulated by the new policy statements issued by the regulatory agencies, the pharmaceutical industry has systematically begun to develop chiral drugs in enantiometrically enriched pure forms. This new trend has caused a tremendous change in the industrial small- and large-scale production to enantiomerically pure drugs, leading to the revisiting and updating of old technologies, and to the development of new methodologies of their large-scale preparation (as the use of stereoselective syntheses and biocatalyzed reactions). The final decision whether a given chiral drug will be marketed in an enantiomerically pure form, or as a racemic mixture of both enantiomers, will be made weighing all the medical, financial and social proficiencies of one or other form. The kinetic, pharmacological and toxicological properties of individual enantiomers need to be characterized, independently of a final decision.

  17. Coenzyme Q10 treatment ameliorates acute cisplatin nephrotoxicity in mice

    International Nuclear Information System (INIS)

    Fouad, Amr A.; Al-Sultan, Ali Ibrahim; Refaie, Shereen M.; Yacoubi, Mohamed T.

    2010-01-01

    The nephroprotective effect of coenzyme Q10 was investigated in mice with acute renal injury induced by a single i.p. injection of cisplatin (5 mg/kg). Coenzyme Q10 treatment (10 mg/kg/day, i.p.) was applied for 6 consecutive days, starting 1 day before cisplatin administration. Coenzyme Q10 significantly reduced blood urea nitrogen and serum creatinine levels which were increased by cisplatin. Coenzyme Q10 significantly compensated deficits in the antioxidant defense mechanisms (reduced glutathione level and superoxide dismutase activity), suppressed lipid peroxidation, decreased the elevations of tumor necrosis factor-α, nitric oxide and platinum ion concentration, and attenuated the reductions of selenium and zinc ions in renal tissue resulted from cisplatin administration. Also, histopathological renal tissue damage mediated by cisplatin was ameliorated by coenzyme Q10 treatment. Immunohistochemical analysis revealed that coenzyme Q10 significantly decreased the cisplatin-induced overexpression of inducible nitric oxide synthase, nuclear factor-κB, caspase-3 and p53 in renal tissue. It was concluded that coenzyme Q10 represents a potential therapeutic option to protect against acute cisplatin nephrotoxicity commonly encountered in clinical practice.

  18. Medical students' exposure to pharmaceutical industry marketing: a survey at one U.S. medical school.

    Science.gov (United States)

    Bellin, Melena; McCarthy, Susan; Drevlow, Laurel; Pierach, Claus

    2004-11-01

    While much is known about the interactions between the pharmaceutical industry and physicians, very little is known about pharmaceutical marketing directed toward medical students. This study sought to characterize the extent and forms of medical students' exposure to pharmaceutical industry marketing. In 2001-02, an anonymous, 17-item questionnaire was distributed to 165 preclinical and 116 clinical students at the University of Minnesota Medical School-Twin Cities. The main outcome measures were the number and forms of exposures to pharmaceutical industry marketing reported by medical students and whether students had discussed these exposures with teachers or advisors. Preclinical and clinical students were compared using chi(2) analysis (p marketing. Seventy-six (71.7%) clinical students compared to 38 (33.3%) preclinical students recalled over 20 exposures (p textbook (p marketing with an instructor or advisor; 59 (55.7%) clinical students as compared to 87 (80.6%) preclinical students recalled no such discussion (p marketing during their early years of training. Given existing evidence that such exposure influences physicians' practice and prescribing patterns, the authors propose that medical school curricula include formal instruction to prepare students to critically assess these contacts.

  19. Novel Lipid-Free Nanoformulation for Improving Oral Bioavailability of Coenzyme Q10

    Directory of Open Access Journals (Sweden)

    Huafeng Zhou

    2014-01-01

    Full Text Available To improve the bioavailability of orally administered lipophilic coenzyme Q10 (CoQ10, we formulated a novel lipid-free nano-CoQ10 system stabilized by various surfactants. Nano-CoQ10s, composed of 2.5% (w/w CoQ10, 1.67% (w/w surfactant, and 41.67% (w/w glycerol, were prepared by hot high-pressure homogenization. The resulting formulations were characterized by particle size, zeta potential, differential scanning calorimetry, and cryogenic transmission electron microscopy. We found that the mean particle size of all nano-CoQ10s ranged from 66.3±1.5 nm to 92.7±1.5 nm and the zeta potential ranged from -12.8±1.4 mV to -41.6±1.4 mV. The CoQ10 in nano-CoQ10s likely existed in a supercooled state, and nano-CoQ10s stored in a brown sealed bottle were stable for 180 days at 25°C. The bioavailability of CoQ10 was evaluated following oral administration of CoQ10 formulations in Sprague-Dawley rats. Compared to the values observed following administration of CoQ10-Suspension, nano-CoQ10 modified with various surfactants significantly increased the maximum plasma concentration and the area under the plasma concentration-time curve. Thus, the lipid-free system of a nano-CoQ10 stabilized with a surfactant may be an effective vehicle for improving oral bioavailability of CoQ10.

  20. Microbial Tyrosinases: Promising Enzymes for Pharmaceutical, Food Bioprocessing, and Environmental Industry

    Directory of Open Access Journals (Sweden)

    Kamal Uddin Zaidi

    2014-01-01

    Full Text Available Tyrosinase is a natural enzyme and is often purified to only a low degree and it is involved in a variety of functions which mainly catalyse the o-hydroxylation of monophenols into their corresponding o-diphenols and the oxidation of o-diphenols to o-quinones using molecular oxygen, which then polymerizes to form brown or black pigments. The synthesis of o-diphenols is a potentially valuable catalytic ability and thus tyrosinase has attracted a lot of attention with respect to industrial applications. In environmental technology it is used for the detoxification of phenol-containing wastewaters and contaminated soils, as biosensors for phenol monitoring, and for the production of L-DOPA in pharmaceutical industries, and is also used in cosmetic and food industries as important catalytic enzyme. Melanin pigment synthesized by tyrosinase has found applications for protection against radiation cation exchangers, drug carriers, antioxidants, antiviral agents, or immunogen. The recombinant V. spinosum tryosinase protein can be used to produce tailor-made melanin and other polyphenolic materials using various phenols and catechols as starting materials. This review compiles the recent data on biochemical and molecular properties of microbial tyrosinases, underlining their importance in the industrial use of these enzymes. After that, their most promising applications in pharmaceutical, food processing, and environmental fields are presented.

  1. Spin-off and Innovation in the Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Enzo Peruffo

    2014-11-01

    Full Text Available Parent companies usually undertake corporate spin-offs to cope with higher competitive environments or when, in high technology industries, the differences between R&D investments and intangible assets are larger. Consistent with the recent “positive view”, spinoffs can be considered as a “proactive strategic choice” to foster innovation, develop new activities, being different from past strategic initiatives and, more generally, not being strictly connected to the corporate strategy of the firm. In order to investigate the relation between divestiture decisions and innovation, we conduct an explorative case study in the pharmaceutical industry to show how spin-offs can help firms to explore new opportunities for innovation, search for new funding and push to create the basis for future development.

  2. "Does organizational culture influence the ethical behavior in the pharmaceutical industry?".

    Science.gov (United States)

    Nagashekhara, Molugulu; Agil, Syed Omar Syed

    2011-12-01

    Study of ethical behavior among medical representatives in the profession is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the influence of organizational culture on ethical behavior of medical representatives. Medical representatives working for both domestic and multinational companies constitutes the sample (n=300). Data is collected using a simple random and cluster sampling through a structured questionnaire. The research design is hypothesis testing. It is a cross-sectional and correlational study, conducted under non-contrived settings. Chi-square tests were shows that there is an association between the organizational culture and ethical behavior of medical representatives. In addition, the strength of the association is measured which report to Cramer's V of 63.1% and Phi Value of 2.749. Results indicate that multinational company medical reps are more ethical compared to domestic company medical representatives vast difference in both variance and in t test results. Through better organizational culture, pharmaceutical companies can create the most desirable behavior among their employees. Authors conclude that apart from organizational culture, the study of additional organizational, individual and external factors are imperative for better understanding of ethical behavior of medical representatives in the pharmaceutical industry in India.

  3. 46,XY,DUP(10Q) IN DIRECT CVS PREPARATION AND MOSAIC 48,XXXY,DUP(10Q) IN CVS LONG-TERM CULTURE AND FETAL TISSUE

    NARCIS (Netherlands)

    SIJMONS, RH; SIKKEMARADDATZ, B; KLOOSTERMAN, MD; BRIET, JW; DEJONG, B; LESCHOT, NJ

    Chorionic villus sampling (CVS) was performed on a 40-year-old woman at 9 1/2 menstrual weeks because of advanced maternal age. The direct preparation showed 46,XY,dup(10)(q11.2q23.2). CVS long-term culture and fetal tissue revealed a rare additional abnormality: 48,XXXY,dup(10)(q11.2q23.2). This

  4. [Research in the pharmaceutical industry cannot be objective].

    Science.gov (United States)

    Becker-Brüser, Wolfgang

    2010-01-01

    In the face of tight public budgets more and more studies are being funded by the pharmaceutical industry. At the same time responsibility for conducting company-funded trials is increasingly being shifted to contract research organisations. Pharmaceutical manufacturers sponsor trials that primarily pursue company interests. The dominance of company-funded research does not only have a bearing on the choice of study priorities, though. Company sponsorship also has an influence on the results of trials. Company-funded trials are four times more likely to find evidence in favour of the trial drug than studies funded by other sponsors. There are several contributory factors, from study design (design bias) to data manipulation. And non-publication (publication bias) can distort knowledge. As a result, it is largely impossible to reliably assess the benefit and harm of medical drugs on the basis of published trials. This will have repercussions for the reliability of meta-analyses, guidelines and patient information leaflets. One consequence may be treatment errors.

  5. Pattern of Duplicate Presentations at National Hematology-Oncology Meetings: Influence of the Pharmaceutical Industry.

    Science.gov (United States)

    Ramchandren, Radhakrishnan; Schiffer, Charles A

    2016-03-01

    The major large US hematology-oncology meetings sponsored by the American Society of Hematology (ASH) and American Society of Clinical Oncology (ASCO) have specific guidelines in place discouraging submission of scientific information presented previously at other meetings. Nonetheless, duplicate submissions are frequent. The incidence and motivations for duplicate hematologic presentations and the influence of the pharmaceutical industry on this process have not been thoroughly analyzed. Therefore, were viewed four consecutive ASH and ASCO meetings to assess the frequency of duplicate abstract presentations. All abstracts presented at ASCO2010 in the area of malignant hematology were compared with abstracts from ASCO and ASH 2009 and ASH 2010, and funding sources were reviewed. More than half (54%) of all abstracts submitted to ASCO 2010 acknowledged pharmaceutical company support. Almost one third (31%) of ASCO 2010 abstracts were resubmitted in the 2-year time period, and it was notable that a high fraction (75%) of these duplicate abstracts had pharmaceutical industry sponsorship, compared with 42% of the abstracts that were submitted only once. Despite current guidelines prohibiting duplicate abstract presentation, a substantial proportion (31%) of abstracts at large international hematology-oncology meetings are duplicative, with potential negative consequences. In addition, a disproportionate percentage of the duplicate abstracts rely on pharmaceutical industry support (75%), suggesting that marketing strategies may be a motivation for some of these repetitive submissions.

  6. Qualitative Phenomenological Examination of IT Project Management in Pharmaceutical Industry

    Science.gov (United States)

    Ly, Phil

    2013-01-01

    The purpose of this study was to examine what caused IT projects to fail at a high rate in the pharmaceutical industry. IT projects failures delayed development of new drugs that can help save lives. It was imperative to evaluate what caused project failures because the collateral damage was delay in drug development. This qualitative…

  7. Treatment of CoQ(10 deficient fibroblasts with ubiquinone, CoQ analogs, and vitamin C: time- and compound-dependent effects.

    Directory of Open Access Journals (Sweden)

    Luis C López

    2010-07-01

    Full Text Available Coenzyme Q(10 (CoQ(10 and its analogs are used therapeutically by virtue of their functions as electron carriers, antioxidant compounds, or both. However, published studies suggest that different ubiquinone analogs may produce divergent effects on oxidative phosphorylation and oxidative stress.To test these concepts, we have evaluated the effects of CoQ(10, coenzyme Q(2 (CoQ(2, idebenone, and vitamin C on bioenergetics and oxidative stress in human skin fibroblasts with primary CoQ(10 deficiency. A final concentration of 5 microM of each compound was chosen to approximate the plasma concentration of CoQ(10 of patients treated with oral ubiquinone. CoQ(10 supplementation for one week but not for 24 hours doubled ATP levels and ATP/ADP ratio in CoQ(10 deficient fibroblasts therein normalizing the bioenergetics status of the cells. Other compounds did not affect cellular bioenergetics. In COQ2 mutant fibroblasts, increased superoxide anion production and oxidative stress-induced cell death were normalized by all supplements.THESE RESULTS INDICATE THAT: 1 pharmacokinetics of CoQ(10 in reaching the mitochondrial respiratory chain is delayed; 2 short-tail ubiquinone analogs cannot replace CoQ(10 in the mitochondrial respiratory chain under conditions of CoQ(10 deficiency; and 3 oxidative stress and cell death can be counteracted by administration of lipophilic or hydrophilic antioxidants. The results of our in vitro experiments suggest that primary CoQ(10 deficiencies should be treated with CoQ(10 supplementation but not with short-tail ubiquinone analogs, such as idebenone or CoQ(2. Complementary administration of antioxidants with high bioavailability should be considered if oxidative stress is present.

  8. [Early achievements of the Danish pharmaceutical industry-7].

    Science.gov (United States)

    Grevsen, Jørgen V; Kirkegaard, Hanne; Kruse, Edith; Kruse, Poul R

    2014-01-01

    A/S GEA Farmaceutisk Fabrik was established as a family business in 1927 by the pharmacist Knud L. Gad Andresen who until then had been employed in the pharmaceutical industry. Gad Andresen wanted to run a company focusing on the development of generics, and he wanted this development to take place in a close cooperation with Danish physicians. This has indeed been achieved with success. In 1995 GEA was purchase'd by the American pharmaceutical company Bristol-Myers Squibb who in a press release characterized GEA as Denmark's second largest manufacturer of generics. Immediately after this takeover GEA's R&D department ceased the research in innovative products and from now on exclusively focused on the development of generics. Three years later GEA was sold to the German generic company Hexal who later on resold GEA to the Swiss generic company Sandoz. GEA changed ownership another couple of times until the last owner went bankrupt in 2011. GEA is yet again a model example of an early Danish pharmaceutical company which was established as an individual company, and which had a long commercial success with the production and marketing of generics. GEA's earliest products, the organotherapeutics, were not innovations. The innovative products were developed already in the 1890s in Denmark by Alfred Benzon, and later on copies followed a.o. from Medicinalco and from foreign companies before GEA marketed their generics. Therefore GEA had to promote their preparations as especially qualified medicinal products and to intimate that the products of the competitors were less "active'". At the end of the 1920s the Ministry of Health became aware of the fact that there might be health problems related to the none-existing control of both the or- ganotherapeutic preparations and actually also the other medicinal products of the pharmaceutical industry. Therefore the Ministry had requested the National Board of Health for a statement regarding this problem. The National Board

  9. Evaluation of cleaner production audit in pharmaceutical production industry: case study of the pharmaceutical plant in Dalian, P. R. China

    Energy Technology Data Exchange (ETDEWEB)

    Li, Zhi-dong [Dalian University of Technology, Key Laboratory of Industrial Ecology and Environmental Engineering (MOE), School of Environmental Science and Technology, Dalian (China); Dalian Cleaner Production Centre, Dalian, Liaoning (China); Dalian Municipal Design and Research Institute of Environmental Science, Dalian, Liaoning (China); Zhang, Shu-shen; Zhang, Yun [Dalian University of Technology, Key Laboratory of Industrial Ecology and Environmental Engineering (MOE), School of Environmental Science and Technology, Dalian (China); Zhang, Yong; Wei, Li [Dalian Cleaner Production Centre, Dalian, Liaoning (China); Dalian Municipal Design and Research Institute of Environmental Science, Dalian, Liaoning (China)

    2011-02-15

    The pharmaceutical industry in China makes an important contribution to the national economy. However, the associated pollution problems cause gradual deterioration of the environment and impact adversely on the local community. Cleaner production (CP) technology, an effective way to reduce waste emission and save resources, has been widely employed in the pharmaceutical industry in the developed countries. Such technologies have been applied in a number of factories in China, although there is no integrated assessment and implementation procedure for implementing CP technologies in pharmaceutical plants. To solve such problems, a series of CP options are proposed and assessed here. CP is a powerful tool for decreasing waste production, limiting environmental pollution and natural resource depletion. Moreover, the return on investment in CP is quick, so it would seem that CP activities should be very much in demand by enterprises. Reality is less optimistic: frequently only limited interest is expressed, even after an explanation; business people hesitate to become actively involved. The processes in the pharmaceutical production industry produce a vast amount of waste, including wastewater with high concentrations of organic substances (the principal component), solid waste, and organic off-gas. To solve such problems, a series of CP options are proposed and assessed in this study. Having consideration to environmental impacts and economic efficiency, four groups of medium/high cost CP options were screened in an integrated assessment. To verify the proposed options, a case study was conducted in Degussa Luyuan, Northeast China. The characteristics of resource consumption and waste emission during the production process were identified. The proposed options were evaluated according to different aspects. An integrated CP system based on the proposed options was designed and then implemented in the factory. In three years of practical use, the productivity and

  10. Membrane-Based Technologies in the Pharmaceutical Industry and Continuous Production of Polymer-Coated Crystals/Particles.

    Science.gov (United States)

    Chen, Dengyue; Sirkar, Kamalesh K; Jin, Chi; Singh, Dhananjay; Pfeffer, Robert

    2017-01-01

    Membrane technologies are of increasing importance in a variety of separation and purification applications involving liquid phases and gaseous mixtures. Although the most widely used applications at this time are in water treatment including desalination, there are many applications in chemical, food, healthcare, paper and petrochemical industries. This brief review is concerned with existing and emerging applications of various membrane technologies in the pharmaceutical and biopharmaceutical industry. The goal of this review article is to identify important membrane processes and techniques which are being used or proposed to be used in the pharmaceutical and biopharmaceutical operations. How novel membrane processes can be useful for delivery of crystalline/particulate drugs is also of interest. Membrane separation technologies are extensively used in downstream processes for bio-pharmaceutical separation and purification operations via microfiltration, ultrafiltration and diafiltration. Also the new technique of membrane chromatography allows efficient purification of monoclonal antibodies. Membrane filtration techniques of reverse osmosis and nanofiltration are being combined with bioreactors and advanced oxidation processes to treat wastewaters from pharmaceutical plants. Nanofiltration with organic solvent-stable membranes can implement solvent exchange and catalyst recovery during organic solvent-based drug synthesis of pharmaceutical compounds/intermediates. Membranes in the form of hollow fibers can be conveniently used to implement crystallization of pharmaceutical compounds. The novel crystallization methods of solid hollow fiber cooling crystallizer (SHFCC) and porous hollow fiber anti-solvent crystallization (PHFAC) are being developed to provide efficient methods for continuous production of polymer-coated drug crystals in the area of drug delivery. This brief review provides a general introduction to various applications of membrane technologies in

  11. In vitro effects of zinc, D-aspartic acid, and coenzyme-Q10 on sperm function.

    Science.gov (United States)

    Giacone, Filippo; Condorelli, Rosita A; Mongioì, Laura M; Bullara, Valentina; La Vignera, Sandro; Calogero, Aldo E

    2017-05-01

    Reactive oxygen species favor reproductive processes at low concentrations, but damage spermatozoa and decrease their fertilizing capacity at high concentrations. During infection and/or inflammation of the accessory sex glands reactive oxygen species overproduction may occur which, in turn, may negatively impact on sperm motility, sperm DNA fragmentation, and lipid peroxidation. A number of nutraceutical formulations containing antioxidant molecules have been developed to counteract the deleterious effects of the oxidative stress. A recent formulation containing zinc, D-aspartic acid, and coenzyme-Q10 is present in the pharmaceutical market. Based on these premises, the aim of the present study was to evaluate the effects of this combination on spermatozoa in vitro. The study was conducted on 24 men (32.2 ± 5.5 years): 12 normozoospermic men and 12 asthenozoospermic patients. Spermatozoa from each sample were divided into two control aliquots (aliquot A and B) and an aliquot incubated with zinc, D-aspartic acid, and coenzyme-Q10 (aliquot C). After 3 h of incubation, the following parameters were evaluated: progressive motility, number of spermatozoa with progressive motility recovered after swim-up, lipid peroxidation, and DNA fragmentation. Incubation with zinc, D-aspartic acid, and coenzyme-Q10 maintained sperm motility in normozoospermic men (37.7 ± 1.2 % vs. 35.8 ± 2.3 % at time zero) and improved it significantly in asthenozoospermic patients (26.5 ± 1.9 % vs. 18.8 ± 2.0 % at time zero) (p aspartic acid, and coenzyme-Q10 (p < 0.05) in both normozospermic men (1.0 ± 0.4 % vs. 2.4 ± 0.9 %) and asthenozooseprmic patients (0.2 ± 0.1 % vs. 0.6 ± 0.2 %). No statistically significant effect was observed on sperm DNA fragmentation. This nutraceutical formulation may be indicated in vitro during the separation of the spermatozoa in the assisted reproduction techniques, during which the spermatozoa

  12. Syntenic homology of human unique DNA sequences within chromossome regions 5q31, 10q22, 13q32-33 and 19q13.1 in the great apes

    Directory of Open Access Journals (Sweden)

    Rhea U. Vallente-Samonte

    2000-09-01

    Full Text Available Homologies between chromosome banding patterns and DNA sequences in the great apes and humans suggest an apparent common origin for these two lineages. The availability of DNA probes for specific regions of human chromosomes (5q31, 10q22, 13q32-33 and 19q13.1 led us to cross-hybridize these to chimpanzee (Pan troglodytes, PTR, gorilla (Gorilla gorilla, GGO and orangutan (Pongo pygmaeus, PPY chromosomes in a search for equivalent regions in the great apes. Positive hybridization signals to the chromosome 5q31-specific DNA probe were observed at HSA 5q31, PTR 4q31, GGO 4q31 and PPY 4q31, while fluorescent signals using the chromosome 10q22-specific DNA probe were noted at HSA 10q22, PTR 8q22, GGO 8q22 and PPY 7q22. The chromosome arms showing hybridization signals to the Quint-EssentialTM 13-specific DNA probe were identified as HSA 13q32-33, PTR 14q32-33, GGO 14q32-33 and PPY 14q32-33, while those presenting hybridization signals to the chromosome 19q13.1-specific DNA probe were identified as HSA 19q13.1, PTR 20q13, GGO 20q13 and PPY 20q13. All four probes presumably hybridized to homologous chromosomal locations in the apes, which suggests a homology of certain unique DNA sequences among hominoid species.Homologias entre os padrões de bandamento de cromossomos e seqüências de DNA em grandes macacos e humanos sugerem uma aparente origem comum para estas duas linhagens. A disponibilidade de sondas de DNA para regiões específicas de cromossomos humanos (5q31, 10q22, 13q32-33 e 19q13.1 nos levou a realizar hibridação cruzada com cromossomos de chimpanzé (Pan troglodytes, PTR, gorila (Gorilla gorilla, GGO e orangotango (Pongo pygmaeus, PPY em um pesquisa de regiões equivalentes em grandes macacos. Sinais positivos de hibridação para a sonda de DNA específica para o cromossomo 5q31 foram observados em HSA 5q31, PTR 4q31, GGO 4q31 e PPY 4q31, enquanto que sinais fluorescentes usando a sonda de DNA específica para o cromossomo 10q22 foram

  13. Marketing orientation in pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Prošić Danica

    2006-01-01

    Full Text Available Pharmaceutical companies are major stakeholders in the global health agenda Virtually all drugs used by patients in Europe reach markets through the promotion tactics of a small number of corporations with a tremendous impact on global health. The sector is both fast growing and highly profitable. Effective marketing strategies are a crucial ingredient in making sure pharmaceutical products and profits flow in a virtuous cycle. At first glance, the relationship between doctors and drug companies, as well as advertising practices for over-the-counter medication, appears tightly regulated. According to many consumer organizations, drug promotion in Europe today can be characterized as nice and friendly marketing. This refers to the creation of a false sense of trust that consumers associate with branded pharmaceutical products, as a result of pharmaceutical marketing efforts disguised as genuine corporate responsibility.

  14. Global gene mining and the pharmaceutical industry

    International Nuclear Information System (INIS)

    Knudsen, Lisbeth E.

    2005-01-01

    Worldwide efforts are ongoing in optimizing medical treatment by searching for the right medicine at the right dose for the individual. Metabolism is regulated by polymorphisms, which may be tested by relatively simple SNP analysis, however requiring DNA from the test individuals. Target genes for the efficiency of a given medicine or predisposition of a given disease are also subject to population studies, e.g., in Iceland, Estonia, Sweden, etc. For hypothesis testing and generation, several bio-banks with samples from patients and healthy persons within the pharmaceutical industry have been established during the past 10 years. Thus, more than 100,000 samples are stored in the freezers of either the pharmaceutical companies or their contractual partners at universities and test institutions. Ethical issues related to data protection of the individuals providing samples to bio-banks are several: nature and extent of information prior to consent, coverage of the consent given by the study person, labeling and storage of the sample and data (coded or anonymized). In general, genetic test data, once obtained, are permanent and cannot be changed. The test data may imply information that is not beneficial to the patient and his/her family (e.g., employment opportunities, insurance, etc.). Furthermore, there may be a long latency between the analysis of the genetic test and the clinical expression of the disease and wide differences in the disease patterns. Consequently, information about some genetic test data may stigmatize patients leading to poor quality of life. This has raised the issue of 'genetic exceptionalism' justifying specific regulation of use of genetic information. Discussions on how to handle sampling and data are ongoing within the industry and the regulatory sphere, the European Agency for the Evaluation of Medicinal Products (EMEA) having issued a position paper, the Council for International Organizations of Medical Sciences (CIOMS) having a working

  15. The t(10;14)(q24;q11) of T-cell acute lymphoblastic leukemia juxtaposes the δT-cell receptor with TCL3, a conserved and activated locus at 10q24

    International Nuclear Information System (INIS)

    Zutter, M.; Hockett, R.D.; Roberts, C.W.M.; McGuire, E.A.; Bloomstone, J.; Korsmeyer, S.J.; Morton, C.C.; Deaven, L.L.; Crist, W.M.; Carroll, A.J.

    1990-01-01

    The authors cloned the t(10;14) recurrent translocation from CD3-negative T-cell acute lymphoblastic leukemia cells. The breakpoint at 14q11 involved an intermediate rearrangement of the δ T-cell receptor locus, suggesting that the translocation arose at the time of antigen receptor assemblage. Translocation introduced chromosome segment 10q24 as proven by hybridization of a breakpoint-derived probe to flow-sorted chromosomes and metaphase chromosomes. Two t(10;14) breakpoints were clustered within a 600-base-pair region of 10q24 but no heptamer-spacer-nonamer motifs resembling T-cell receptor/immunoglobulin rearrangement signals were noted at the breakpoint. A locus distinct from terminal deoxynucleotidyltransferase was found at 10q24. Evolutionarily conserved regions surrounding the 10q24 breakpoint were examined for transcriptional activity. A region telomeric to the 10q24 breakpoint, expected to translocate to the der(14) chromosome, recognized an abundant 2.9-kilobase RNA in a t(10;14) T-cell leukemia. This locus was not active in a variety of other normal and neoplastic T cells, arguing that it was deregulated by he introduction of the T-cell receptor. This locus is a candidate for a putative protooncogene, TCL3, involved in T-cell neoplasia

  16. Characteristics of physicians targeted by the pharmaceutical industry to participate in e-detailing.

    Science.gov (United States)

    Alkhateeb, Fadi M; Khanfar, Nile M; Doucette, William R; Loudon, David

    2009-01-01

    Electronic detailing (e-detailing) has been introduced in the last few years by the pharmaceutical industry as a new communication channel through which to promote pharmaceutical products to physicians. E-detailing involves using digital technology, such as Internet, video conferencing, and interactive voice response, by which drug companies target their marketing efforts toward specific physicians with pinpoint accuracy. A mail survey of 671 Iowa physicians was used to gather information about the physician characteristics and practice setting characteristics of those who are usually targeted by pharmaceutical companies to participate in e-detailing. A model is developed and tested to explain firms' targeting strategy for targeting physicians for e-detailing.

  17. Micronutrient special issue: Coenzyme Q{sub 10} requirements for DNA damage prevention

    Energy Technology Data Exchange (ETDEWEB)

    Schmelzer, Constance, E-mail: schmelzer@fbn-dummerstorf.de [Leibniz Institute for Farm Animal Biology (FBN), Nutritional Physiology, Wilhelm-Stahl-Allee 2, 18196 Dummerstorf (Germany); Doering, Frank [University of Kiel, Institute of Human Nutrition and Food Science, Molecular Prevention, Heinrich-Hecht-Platz 10, 24118 Kiel (Germany)

    2012-05-01

    Coenzyme Q{sub 10} (CoQ{sub 10}) is an essential component for electron transport in the mitochondrial respiratory chain and serves as cofactor in several biological processes. The reduced form of CoQ{sub 10} (ubiquinol, Q{sub 10}H{sub 2}) is an effective antioxidant in biological membranes. During the last years, particular interest has been grown on molecular effects of CoQ{sub 10} supplementation on mechanisms related to DNA damage prevention. This review describes recent advances in our understanding about the impact of CoQ{sub 10} on genomic stability in cells, animals and humans. With regard to several in vitro and in vivo studies, CoQ{sub 10} provides protective effects on several markers of oxidative DNA damage and genomic stability. In comparison to the number of studies reporting preventive effects of CoQ{sub 10} on oxidative stress biomarkers, CoQ{sub 10} intervention studies in humans with a direct focus on markers of DNA damage are limited. Thus, more well-designed studies in healthy and disease populations with long-term follow up results are needed to substantiate the reported beneficial effects of CoQ{sub 10} on prevention of DNA damage.

  18. Nonclinical statistics for pharmaceutical and biotechnology industries

    CERN Document Server

    2016-01-01

    This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The cha...

  19. Assessment of Nelumbo nucifera and Hydrilla verticillata in the treatment of pharmaceutical industry effluent from 24 Parganas, West Bengal

    Directory of Open Access Journals (Sweden)

    Shamba Chatterjee

    2014-10-01

    Full Text Available Modern day technologies employed in industrialization and unhygienic lifestyle of mankind has led to a severe environmental menace resulting in pollution of freshwater bodies. Pharmaceutical industry effluents cause eutrophication and provide adequate nutrients for growth of pathogenic bacteria. This study has been conducted with aquatic plants water lotus (Nelumbo nucifera and hydrilla (Hydrilla verticillata with an novel aim to treat pharmaceutical industry effluents showing the outcome of the experiments carried out with the effluents collected from rural areas of 24 Parganas, West Bengal, India. Determination of pH, solid suspend, BOD5, NH3-N, MPN and coliform test were used for this notioned purpose. Pharmaceutical waste effluent water treated with water lotus showed less pH, solid suspend, DO, BOD, NH3-N, MPN and coliform bacteria than hydrilla treatment when compared to the control. In conclusion, water lotus is found to be more efficient in treatment of pharmaceutical industry effluent waste water than hydrilla.

  20. Collaborating to Compete: A Search into Capabilities and Strategic Alliances in the Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Marisa Ohba

    2007-06-01

    Full Text Available Athough there is a profusion of studies related to strategic alliances and technological capacities which evaluate the issues individually, there is a scarcity of studies with empirical evidence relative to the implications of strategic alliances at the technological capacity configuration. Drawing on a scrutiny of specialised databases (Galé, Dialog, and Business & Industry covering the 1993-2003 period, this article examines the entry and exit composition of innovative capabilities of 25 pharmaceutical companies’ capabilities involved in such alliances. They are organised in three groups: (i large pharmaceutical companies (‘big-pharma’; (ii large bio-pharmaceutical companies (‘bio-pharma’; and (iii small and research-intensive companies. In terms of strategic alliance implications, a change was observed on the technological capacities’ configuration. The evidence suggests that the criteria for partner choice and technological capacity depend on the objectives and needs of each different group of company. Such type of evidence is important to provide researchers, corporate managers, and policy-makers with a concrete notion of the extent to which such division of innovative labour occurs and the actual changes going on the structure and organisation of innovative activities in the pharmaceutical industry.

  1. Managing the interface with marketing to improve delivery of pharmacovigilance within the pharmaceutical industry.

    Science.gov (United States)

    Edwards, Brian

    2004-01-01

    The pharmaceutical industry is under pressure to improve the scientific quality of its decisions concerning the benefit and risks of its products while ensuring compliance with acceptable standards of marketing. All those in a pharmaceutical company who currently work within pharmacovigilance should be encouraged to lead from the front to examine ongoing marketing activities to see how they can be adapted more towards pharmacovigilance and risk management. The current irony is that the personnel who have the greatest influence on benefit-risk decisions of a product are not necessarily those who acknowledge that they are performing pharmacovigilance. Indeed, for all concerned, whether their orientation is scientific and commercial, effective communication with prescribers and consumers usually underpins product success. Also, a substantial 'marketing' budget is culturally acceptable for the pharmaceutical industry so it is logical to assume that resource for postmarketing activity is often made available. Given these realities, I suggest we should strive for an integrated marketing and risk-management plan based on the best available evidence and that being fully aware and in control of the safety issues for your products is the best way to commercialise them successfully. This approach can still be consistent with other corporate responsibilities such as trying to reduce the financial burden of product development. If this article stimulates further debate about how the pharmaceutical industry can more effectively organise resources and operations to support pharmacovigilance, risk management, and marketing, then it will have achieved its purpose.

  2. Hormonal Influence on Coenzyme Q10 Levels in Blood Plasma

    Directory of Open Access Journals (Sweden)

    Alfredo Pontecorvi

    2011-12-01

    Full Text Available Coenzyme Q10 (CoQ10, also known as ubiquinone for its presence in all body cells, is an essential part of the cell energy-producing system. However, it is also a powerful lipophilic antioxidant protecting lipoproteins and cell membranes. Due to these two actions, CoQ10 is commonly used in clinical practice in chronic heart failure, male infertility, and neurodegenerative disease. However, it is also taken as an anti-aging substance by healthy people aiming for long-term neuroprotection and by sportsmen to improve endurance. Many hormones are known to be involved in body energy regulation, in terms of production, consumption and dissipation, and their influence on CoQ10 body content or blood values may represent an important pathophysiological mechanism. We summarize the main findings of the literature about the link between hormonal systems and circulating CoQ10 levels. In particular the role of thyroid hormones, directly involved in the regulation of energy homeostasis, is discussed. There is also a link with gonadal and adrenal hormones, partially due to the common biosynthetic pathway with CoQ10, but also to the increased oxidative stress found in hypogonadism and hypoadrenalism.

  3. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Science.gov (United States)

    2012-10-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1010] Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical... certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs...

  4. Measuring brand loyalty in the pharmaceutical industry of South Africa / Hilde du Plooy

    OpenAIRE

    Du Plooy, Hilde

    2012-01-01

    Brands are recognised as one of the most valuable assets that a company can possess and therefore brands are key role-players in the business strategies of organisations. The rivalry amongst competitors in the pharmaceutical industry is fierce and companies should design their strategies in such a way in order to achieve competitive advantage. Brand loyalty is regarded as a powerful tool in the development of pharmaceutical brands. The main aim of this study was to measure b...

  5. What do pharmaceutical industry professionals in Europe believe about involving patients and the public in research and development of medicines? A qualitative interview study.

    Science.gov (United States)

    Parsons, Suzanne; Starling, Bella; Mullan-Jensen, Christine; Tham, Su-Gwan; Warner, Kay; Wever, Kim

    2016-01-07

    To explore European-based pharmaceutical industry professionals' beliefs about patient and public involvement (PPI) in medicines research and development (R&D). Pharmaceutical companies in the UK, Poland and Spain. 21 pharmaceutical industry professionals, four based in the UK, five with pan-European roles, four based in Spain and eight based in Poland. Qualitative interview study (telephone and face-to-face, semistructured interviews). All interviews were audio taped, translated (where appropriate) and transcribed for analysis using the Framework approach. 21 pharmaceutical industry professionals participated. Key themes were: beliefs about (1) whether patients and the public should be involved in medicines R&D; (2) the barriers and facilitators to PPI in medicines R&D and (3) how the current relationships between the pharmaceutical industry, patient organisations and patients influence PPI in medicines R&D. Although interviewees appeared positive about PPI, many were uncertain about when, how and which patients to involve. Patients and the public's lack of knowledge and interest in medicines R&D, and the pharmaceutical industry's lack of knowledge, interest and receptivity to PPI were believed to be key challenges to increasing PPI. Interviewees also believed that relationships between the pharmaceutical industry, patient organisations, patients and the public needed to change to facilitate PPI in medicines R&D. Existing pharmaceutical industry codes of practice and negative media reporting of the pharmaceutical industry were also seen as negative influences on these relationships. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  6. Effect of Coenzyme-Q10 on Doxorubicin-Induced Nephrotoxicity in Rats

    Directory of Open Access Journals (Sweden)

    Azza A. K. El-Sheikh

    2012-01-01

    Full Text Available Nephrotoxicity is one of the limiting factors for using doxorubicin (Dox as an anticancer chemotherapeutic. Here, we investigated possible protective effect of coenzyme-Q10 (CoQ10 on Dox-induced nephrotoxicity and the mechanisms involved. Two doses (10 and 100 mg/kg of CoQ10 were administered orally to rats for 8 days, in the presence or absence of nephrotoxicity induced by a single intraperitoneal injection of Dox (15 mg/kg at day 4 of the experiment. Our results showed that the low dose of CoQ10 succeeded in reversing Dox-induced nephrotoxicity to control levels (e.g., levels of blood urea nitrogen and serum creatinine, concentrations of renal reduced glutathione (GSH and malondialdehyde, catalase activity and caspase 3 expression, and renal histopathology. Alternatively, the high dose of CoQ10 showed no superior nephroprotection over the low dose, as there were no significant improvements in renal histopathology, catalase activity, or caspase 3 expression compared to the Dox-treated group. Interestingly, the high dose of CoQ10 alone significantly decreased renal GSH level as well as catalase activity and caused a mild induction of caspase 3 expression compared to control, probably due to a prooxidant effect at this dose of CoQ10. We conclude that CoQ10 protects from Dox-induced nephrotoxicity with a precaution to dosage adjustment.

  7. Public Innovation Policy in the Pharmaceutical Industry: the Cases of the EU and USA

    Directory of Open Access Journals (Sweden)

    Z. A. Mamedyarov

    2017-01-01

    Full Text Available Purpose: the main purpose of this article was to study the modern tools of the public innovation policy in the global pharmaceutical industry (US and EU cases, which is one of the most knowledge-intensive sectors of the global economy. During the study, it was necessary to achieve the following objectives: to identify main components of the innovation policy in the sector, to consider the role of intellectual property protection, measures of innovation support, regulatory control and other factors, and, also, to identify comparative characteristics of innovation processes within the US and the EU pharmaceutical sector. Methods: this article is based on a qualitative comparative study of the US and EU innovation policy in the pharmaceutical industry. Industryoriented innovation support measures (i.e. levels of private and public financing have been quantitatively analyzed, including the evaluation of the levels of R&D productivity; also, a comparative study of the pharma patent statistics in the leading countries have been performed. This article highlights the problems of intellectual property protection, which remains an important source of financial stability for major pharma companies being the basis for new innovation agenda. Low R&D productivity and high costs of new innovative drugs together emphasize the significance of the analysis of current innovation processes within the pharmaceutical industry, and could open the way for building more effective managerial and business processes. Results: the global pharmaceutical industry today is under thorough control of government regulators and civil society organizations seeking to improve mechanisms of the drugs distribution, in order to make drugs more accessible, safe and clean. This high regulation level impedes innovation within existing pharma business models, and leads to high costs of the newest drugs. The study revealed that successful pharmaceutical innovation today requires

  8. The Pharmaceutical Industry and the Canadian Government: Folie à Deux.

    Science.gov (United States)

    Lexchin, Joel

    2017-08-01

    The interest of the pharmaceutical industry is in achieving a profit for its shareholders while the interest of the Canadian government should be in protecting public health. However, over the course of the past few decades the actions of the Canadian government have been tilted in favour of industry in two areas. The first is in the relationship between industry and Health Canada and is manifested in the regulation of clinical trials, the drug approval system, drug safety and promotion. The second is in economic policy as it applies to policies about patent protection, the price of medications and measures taken to incentivize research and development. The problems in the relationship are structural and will only be solved through systemic changes. Copyright © 2017 Longwoods Publishing.

  9. Serum Levels of Coenzyme Q10 in Patients with Multiple System Atrophy.

    Directory of Open Access Journals (Sweden)

    Takashi Kasai

    Full Text Available The COQ2 gene encodes an essential enzyme for biogenesis, coenzyme Q10 (CoQ10. Recessive mutations in this gene have recently been identified in families with multiple system atrophy (MSA. Moreover, specific heterozygous variants in the COQ2 gene have also been reported to confer susceptibility to sporadic MSA in Japanese cohorts. These findings have suggested the potential usefulness of CoQ10 as a blood-based biomarker for diagnosing MSA. This study measured serum levels of CoQ10 in 18 patients with MSA, 20 patients with Parkinson's disease and 18 control participants. Although differences in total CoQ10 (i.e., total levels of serum CoQ10 and its reduced form among the three groups were not significant, total CoQ10 level corrected by serum cholesterol was significantly lower in the MSA group than in the Control group. Our findings suggest that serum CoQ10 can be used as a biomarker in the diagnosis of MSA and to provide supportive evidence for the hypothesis that decreased levels of CoQ10 in brain tissue lead to an increased risk of MSA.

  10. Pfizer and the Challenges of the Global Pharmaceutical Industry 2013 (B)

    DEFF Research Database (Denmark)

    Nell, Phillip Christopher

    2013-01-01

    This is part of a case series. The case focuses on describing and analysing the environment, profitability and competitiveness of the global pharmaceutical industry, and to evaluate the current and future strategy of Pfizer. It features a large number of tables with quantitative data that help...... initiatives and responses to the market changes....

  11. Effects of inhibiting CoQ10 biosynthesis with 4-nitrobenzoate in human fibroblasts.

    Directory of Open Access Journals (Sweden)

    Catarina M Quinzii

    Full Text Available Coenzyme Q(10 (CoQ(10 is a potent lipophilic antioxidant in cell membranes and a carrier of electrons in the mitochondrial respiratory chain. We previously characterized the effects of varying severities of CoQ(10 deficiency on ROS production and mitochondrial bioenergetics in cells harboring genetic defects of CoQ(10 biosynthesis. We observed a unimodal distribution of ROS production with CoQ(10 deficiency: cells with <20% of CoQ(10 and 50-70% of CoQ(10 did not generate excess ROS while cells with 30-45% of CoQ(10 showed increased ROS production and lipid peroxidation. Because our previous studies were limited to a small number of mutant cell lines with heterogeneous molecular defects, here, we treated 5 control and 2 mildly CoQ(10 deficient fibroblasts with varying doses of 4-nitrobenzoate (4-NB, an analog of 4-hydroxybenzoate (4-HB and inhibitor of 4-para-hydroxybenzoate:polyprenyl transferase (COQ2 to induce a range of CoQ(10 deficiencies. Our results support the concept that the degree of CoQ(10 deficiency in cells dictates the extent of ATP synthesis defects and ROS production and that 40-50% residual CoQ(10 produces maximal oxidative stress and cell death.

  12. Measuring the efficiency of large pharmaceutical companies: an industry analysis.

    Science.gov (United States)

    Gascón, Fernando; Lozano, Jesús; Ponte, Borja; de la Fuente, David

    2017-06-01

    This paper evaluates the relative efficiency of a sample of 37 large pharmaceutical laboratories in the period 2008-2013 using a data envelopment analysis (DEA) approach. We describe in detail the procedure followed to select and construct relevant inputs and outputs that characterize the production and innovation activity of these pharmaceutical firms. Models are estimated with financial information from Datastream, including R&D investment, and the number of new drugs authorized by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) considering the time effect. The relative performances of these firms-taking into consideration the strategic importance of R&D-suggest that the pharmaceutical industry is a highly competitive sector given that there are many laboratories at the efficient frontier and many inefficient laboratories close to this border. Additionally, we use data from S&P Capital IQ to analyze 2071 financial transactions announced by our sample of laboratories as an alternative way to gain access to new drugs, and we link these transactions with R&D investment and DEA efficiency. We find that efficient laboratories make on average more financial transactions, and the relative size of each transaction is larger. However, pharmaceutical companies that simultaneously are more efficient and invest more internally in R&D announce smaller transactions relative to total assets.

  13. Financial aspects and the future of the pharmaceutical industry in the United States of america.

    Science.gov (United States)

    Karamehic, Jasenko; Ridic, Ognjen; Ridic, Goran; Jukic, Tomislav; Coric, Jozo; Subasic, Djemo; Panjeta, Mirsad; Saban, Aida; Zunic, Lejla; Masic, Izet

    2013-12-01

    The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as "companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use". Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers' lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one of the major problems fuelling aggregate health care cost inflation. Pharmaceuticals have created huge benefits for public health and economic productivity by the means of saving lives, increasing life expectancy, reducing illness related suffering, preventing surgeries and decreasing hospital stays. The goal of this review paper is to show the present conditions and future trends of the pharmaceutical industry in the U.S. THIS PAPER REPRESENTS A THOROUGH LITERATURE REVIEW OF THE MULTIFACETED SOURCES INCLUDING: studies, books, peer reviewed journals, U.S. government sources (i.e. U.S. Census Bureau, U.S. Bureau of Economic Analysis, etc.). In the thirty years pharmaceutical companies have consistently developed and launched new medicines, bringing hope to sick or - at risk patients. They also usually provide above the average financial returns for its shareholders. U.S. pharmaceutical companies had as their goal to discover blockbuster drugs. Blockbuster drugs are generally defined as drugs that solve medical problems common to hundreds of millions of people and, at the same time generate large sales increases and profits for the pharmaceutical companies. The main approach of these companies includes huge investments in research and development (R&D), innovation, marketing and sales. The trend analysis shows that for the most part the era of blockbuster drugs is nearing an end. Numerous blockbuster drugs will be coming off patent in the next few years, opening the way to generics and

  14. Therapeutic implication of coenzyme Q10 during statin therapy: pros and cons

    Directory of Open Access Journals (Sweden)

    Mir-Jamal Hosseini

    2015-09-01

    Full Text Available Coenzyme Q10 (CoQ10 is a vitamin-like substance, and a natural intermediate of electron transport chain (ETC of mitochondria which can accepts and donates electrons from complex I and complex II. CoQ10 shares a biosynthetic pathway with cholesterol and dolichol thus it can be a potential target of the widely available lipid-lowering drugs. The lipid lowering drugs such as statins, are widely administered to individuals who have high cholesterol levels. This article reviews the a clinical benefits of CoQ10 b association between administration of statin and CoQ10 deficiency and c involvement of CoQ10 in statin-associated myopathy.

  15. Characterisation and Skin Distribution of Lecithin-Based Coenzyme Q10-Loaded Lipid Nanocapsules

    Science.gov (United States)

    Zhou, Huafeng; Yue, Yang; Liu, Guanlan; Li, Yan; Zhang, Jing; Yan, Zemin; Duan, Mingxing

    2010-10-01

    The purpose of this study was to investigate the influence of the inner lipid ratio on the physicochemical properties and skin targeting of surfactant-free lecithin-based coenzyme Q10-loaded lipid nanocapsules (CoQ10-LNCs). The smaller particle size of CoQ10-LNCs was achieved by high pressure and a lower ratio of CoQ10/GTCC (Caprylic/capric triglyceride); however, the zeta potential of CoQ10-LNCs was above /- 60 mV/ with no distinct difference among them at different ratios of CoQ10/GTCC. Both the crystallisation point and the index decreased with the decreasing ratio of CoQ10/GTCC and smaller particle size; interestingly, the supercooled state of CoQ10-LNCs was observed at particle size below about 200 nm, as verified by differential scanning calorimetry (DSC) in one heating-cooling cycle. The lecithin monolayer sphere structure of CoQ10-LNCs was investigated by cryogenic transmission electron microscopy (Cryo-TEM). The skin penetration results revealed that the distribution of Nile red-loaded CoQ10-LNCs depended on the ratio of inner CoQ10/GTCC; moreover, epidermal targeting and superficial dermal targeting were achieved by the CoQ10-LNCs application. The highest fluorescence response was observed at a ratio of inner CoQ10/GTCC of 1:1. These observations suggest that lecithin-based LNCs could be used as a promising topical delivery vehicle for lipophilic compounds.

  16. Characterisation and Skin Distribution of Lecithin-Based Coenzyme Q10-Loaded Lipid Nanocapsules

    Directory of Open Access Journals (Sweden)

    Yan Zemin

    2010-01-01

    Full Text Available Abstract The purpose of this study was to investigate the influence of the inner lipid ratio on the physicochemical properties and skin targeting of surfactant-free lecithin-based coenzyme Q10-loaded lipid nanocapsules (CoQ10-LNCs. The smaller particle size of CoQ10-LNCs was achieved by high pressure and a lower ratio of CoQ10/GTCC (Caprylic/capric triglyceride; however, the zeta potential of CoQ10-LNCs was above /− 60 mV/ with no distinct difference among them at different ratios of CoQ10/GTCC. Both the crystallisation point and the index decreased with the decreasing ratio of CoQ10/GTCC and smaller particle size; interestingly, the supercooled state of CoQ10-LNCs was observed at particle size below about 200 nm, as verified by differential scanning calorimetry (DSC in one heating–cooling cycle. The lecithin monolayer sphere structure of CoQ10-LNCs was investigated by cryogenic transmission electron microscopy (Cryo-TEM. The skin penetration results revealed that the distribution of Nile red-loaded CoQ10-LNCs depended on the ratio of inner CoQ10/GTCC; moreover, epidermal targeting and superficial dermal targeting were achieved by the CoQ10-LNCs application. The highest fluorescence response was observed at a ratio of inner CoQ10/GTCC of 1:1. These observations suggest that lecithin-based LNCs could be used as a promising topical delivery vehicle for lipophilic compounds.

  17. A quality by design study applied to an industrial pharmaceutical fluid bed granulation.

    Science.gov (United States)

    Lourenço, Vera; Lochmann, Dirk; Reich, Gabriele; Menezes, José C; Herdling, Thorsten; Schewitz, Jens

    2012-06-01

    The pharmaceutical industry is encouraged within Quality by Design (QbD) to apply science-based manufacturing principles to assure quality not only of new but also of existing processes. This paper presents how QbD principles can be applied to an existing industrial pharmaceutical fluid bed granulation (FBG) process. A three-step approach is presented as follows: (1) implementation of Process Analytical Technology (PAT) monitoring tools at the industrial scale process, combined with multivariate data analysis (MVDA) of process and PAT data to increase the process knowledge; (2) execution of scaled-down designed experiments at a pilot scale, with adequate PAT monitoring tools, to investigate the process response to intended changes in Critical Process Parameters (CPPs); and finally (3) the definition of a process Design Space (DS) linking CPPs to Critical to Quality Attributes (CQAs), within which product quality is ensured by design, and after scale-up enabling its use at the industrial process scale. The proposed approach was developed for an existing industrial process. Through enhanced process knowledge established a significant reduction in product CQAs, variability already within quality specifications ranges was achieved by a better choice of CPPs values. The results of such step-wise development and implementation are described. Copyright © 2012 Elsevier B.V. All rights reserved.

  18. Method æ, the agile software development method tailored for the pharmaceutical industry.

    NARCIS (Netherlands)

    Hajou, A.; Batenburg, R.S.; Jansen, S.

    2015-01-01

    Agile software development methods have a high adoption rate due to their proven business benefits. Its success has not yet been identified in the pharmaceutical industry, due to the industry’s incompatibility with generic agile methods. Comprehensive research has been done to engineer a tailored

  19. Understanding evolutionary processes in non-manufacturing industries: Empirical insights from the shakeout in pharmaceutical wholesaling

    OpenAIRE

    Adam J. Fein

    1998-01-01

    Although the empirical pattern of industry shakeout has been documented for many manufacturing industries, we know little about the processes by which market structure evolves in non-manufacturing service industries. This paper establishes detailed empirical observations about the consolidation of a single non-manufacturing industry, the wholesale distribution of pharmaceuticals. These observations are used to explore differences between manufacturing and wholesaling in both the patterns and ...

  20. Globalization of the pharmaceutical industry and the growing dependency of developing countries: the case of Turkey.

    Science.gov (United States)

    Semin, Semih; Güldal, Dilek

    2008-01-01

    In developing countries, the effect of globalization on the pharmaceutical sector has resulted in a decrease in exportation and domestic production, accompanied by an increase in importation of pharmaceuticals and a rise in prices and expenditures. As an example of a developing country, Turkey has been facing the long-standing and increasing pressure of global regulations placed on its pharmaceutical sector. This has led to an increasing dependency on multinational companies and a gradual deterioration of an already weakened domestic pharmaceutical sector. This case study of Turkey offers points to consider in the world of increasing globalization, as it offers lessons on ways of examining the effects of globalization on the pharmaceutical industry of developing countries.

  1. Bioremediation Kinetics of Pharmaceutical Industrial Effluent

    OpenAIRE

    M. Šabić; M. Vuković Domanovac; Z. Findrik Blažević; E. Meštrović

    2015-01-01

    In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmente...

  2. Dynamic competition in pharmaceuticals. Patent expiry, generic penetration, and industry structure.

    Science.gov (United States)

    Magazzini, Laura; Pammolli, Fabio; Riccaboni, Massimo

    2004-06-01

    This paper investigates patterns of industrial dynamics and competition in the pharmaceutical industry, with particular reference to the consequences of patent expiry in different countries. We focus on the competition at the level of single chemical entities, distinguishing between original brands and generic products. Quarterly data, spanning from July 1987 to December 1998, on sales of pharmaceutical products in four countries (USA, UK, Germany, and France) constitute the basis of our analysis. All the products containing major molecules whose patent expiration date lies between 1986 and 1996 are included in our sample. We show how diffusion of generics is linked to the characteristics of the market and investigate how price dynamics of original products are affected by generic competition. Our empirical investigation shows that the dynamics of drug prices and the competition by generic drugs vary significantly across countries. This heterogeneity notwithstanding, a clear distinction seems to emerge. On the one hand, systems that rely on market-based competition in pharmaceuticals promote a clear distinction between firms that act as innovators and firms that act as imitators after patent expiry. Here, original products enjoy premium prices and exclusivity profits under patent protection, and face fierce price competition after patent expiry. On the other hand, in systems that rely on administered prices, penetration by generic drugs tends to be rather limited. Its descriptive and preliminary nature notwithstanding, our analysis seems to have relevant implications at different levels of generality, especially for Europe.

  3. Coenzyme Q10 supplementation and exercise-induced oxidative stress in humans

    DEFF Research Database (Denmark)

    Östman, Bengt; Sjödin, Anders Mikael; Michaëlsson, Karl

    2012-01-01

    Objective: The theoretically beneficial effects of coenzyme Q10 (Q10) on exercise-related oxidative stress and physical capacity have not been confirmed to our knowledge by interventional supplementation studies. Our aim was to investigate further whether Q10 supplementation at a dose recommended...... the groups were detected for hypoxanthine or uric acid (serum markers of oxidative stress) or creatine kinase (a marker of skeletal muscle damage). Conclusion: Although in theory Q10 could be beneficial for exercise capacity and in decreasing oxidative stress, the present study could not demonstrate...

  4. The impact of TRIPS on innovation and exports: a case study of the pharmaceutical industry in India.

    Science.gov (United States)

    Malhotra, Prabodh

    2008-01-01

    Currently, there is a debate on what impact the implementation of the Trade Related Aspects of Intellectual Property Rights (TRIPS) in India would have on its pharmaceutical industry and health care. The debate hinges primarily on two major questions. First, will the new patent regime provide an impetus for innovation in the pharmaceutical industry? Second, how far will India's pharmaceutical exports of copied versions of patented drugs to developing countries be restricted under the new regime? The first question seeks to find out if TRIPS will increase India's innovative capabilities to fill the current vacuum to develop drugs for tropical diseases. The large multinational companies (MNCs) that dominate the global pharmaceutical industry have no interest in commercial ventures that have little potential for great returns on investment. The second question attempts to find a solution to the lack of access to medicine in most developing countries. Indian manufacturers' supply of reverse-engineered drugs, which cost only a fraction of the prices charged by MNCs, may be coming to an end under the new regime. Against this backdrop, this article attempts to analyse the impact of strengthening intellectual property rights in India.

  5. Balneotherapy and coenzyme Q10 in clinical and experimental medicine.

    Science.gov (United States)

    Gvozdjakova, Anna; Kucharska, Jarmila; Sykora, L'ubomir; Singh, Ram B

    2014-01-01

    Balneotherapy or Spa therapy is used in neurological, cardiovascular, musculoskeletal, dermatological and gynecological diseases, in infertility as well as in metabolic disturbances. Beneficial effects of balneotherapy at the metabolic level is not fully understood. Authors have documented enhancement of antioxidants concentrations (coenzyme Q10- CoQ(10-OX) and alpha-tocopherol) of women with gynecological diseases by treatment with natural mineral water (Spa Lucky balneotherapy, Slovakia). In an experiment with rats, drinking of Spa Lucky mineral water decreased oxidative stress and enhanced concentrations of antioxidants CoQ(9-OX), CoQ(10-OX) in the myocardium, and alpha-tocopherol in uterus, ovaries and myocardium. Drinking of Spa Lucky water by rats stimulated myocardial mitochondrial respiration and energy production, and diminished skeletal muscle mitochondrial function. Simultaneous ingestion of coenzyme Q10 with drinking spa water returned mitochondrial parameters to the values of the control group. This pilot study helps explain the role of antioxidants, oxidative stress and mitochondrial energy production in beneficial effects of Spa Lucky balneotherapy.

  6. CoQ10 and L-carnitine for statin myalgia?

    Science.gov (United States)

    DiNicolantonio, James J

    2012-10-01

    Statins are a standard of care in many clinical settings such as acute myocardial infarction and for patients having or at risk of cardiovascular (CV) disease. This is based on a plethora of data showing reductions in CV events and mortality. The CV benefit of statins can be partly explained by their ability to inhibit of HMG-CoA reductase, which subsequently lowers cholesterol and decreases the formation of mevalonate. However, the inhibition of the mevalonate pathway decreases the formation of coenzyme Q10 (CoQ10) within the body. It has been a long-standing theory that statin-associated muscle pain (myalgia) is caused, or at least partly contributed by, a reduction in CoQ10 levels in muscle mitochondria. One of the main side effects of statins is myalgia, which causes the patient to either stop their statin or significantly reduce the dose of their statin. The question of whether CoQ10 can help treat statin myopathy is a common one encountered by clinicians in current day practice.

  7. International Conference on Harmonisation; guidance on Q9 Quality Risk Management; availability. Notice.

    Science.gov (United States)

    2006-06-02

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q9 Quality Risk Management."' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The guidance is intended to enable regulators and industry to make more effective and consistent risk-based decisions.

  8. LIBERALISASI KEUANGAN DAN PENGARUHNYA TERHADAP NILAI Q-TOBIN SEKTOR INDUSTRI DASAR DAN KIMIA DAN PERBANKAN

    Directory of Open Access Journals (Sweden)

    Trias Andati

    2012-05-01

    Full Text Available This research attempts to analyze the effect of financial liberalization to Q-Tobin ratio of Basic and Chemical industry and Banking sectors. Using annual data of 52 listed company’s financial report from 2002 to 2009, the results show that the financial liberalization variables i.e. Foreign Direct Investment (FDI and Investment Portfolio has negative effect on Q-Tobin of Basic and Chemical Industry and Banking sectors. The increase of the financial deepening variables has positive effect on Q-Tobin of Basic and Chemical Industry and Banking sectors. SBI (Sertifikat Bank Indonesia and Money Supply has negative impact on Q-Tobin, while loan interest rates has positive impact on both sectors. The average of net fixed asset investment of two sectors has the same pattern of Q-Tobin values, and increased from 2002 to 2009, while at the year of 2008, Q-Tobin of all sectors experienced decreasing due to financial crisis. Furthermore, there should be a corporate financial performance indicator such as leverage ratio, to prevent short term investment of FDI. Capital Market’s regulation, should be considerate a sectoral policy in portfolio investment, to prevent from financial global crisis. Corporation of two sectors could give more attention on capital structure while analyzing the company’s investment decision.Keywords: Q-Tobin Ratio, Financial Liberalization, Investment, Panel Data

  9. The devil is in the details: the pharmaceutical industry's use of gifts to physicians as marketing strategy.

    Science.gov (United States)

    McFadden, David W; Calvario, Elizabeth; Graves, Cynthia

    2007-06-01

    Marketing costs exceed 30% of revenues for the pharmaceutical industry, with over 90% of the effort aimed at physicians. Although there are currently unprecedented numbers of regulatory activities focusing on relationships between the pharmaceutical industry and the medical profession, such legislation is often unrecognized or flouted. The potential influence, although minimized by both parties, must not be ignored. Physicians and drug companies will need to re-evaluate their responsibilities to their patients and their shareholders, and both groups should assume proactive and guidance roles in the transformation.

  10. Clustering as a determinant of development the competitive pharmaceutical industry - example of Nutribiomed cluster

    Directory of Open Access Journals (Sweden)

    Anna Skowrońska

    2015-04-01

    Full Text Available Continuous improvement and follow the technology seems to be particularly important in terms of health. Given the epidemiological trends is necessary to develop advanced technologies in the medical and pharmaceutical industries. Only innovative solutions offer a chance for a battle with disease, for example, with tumors which are one of the leading causes of death in Europe. This approach perfectly illustrates the strategy known as open innovation, according to which companies should learn from external sources by combining complementary ideas for its ongoing operations. The pharmaceutical industry has a significant impact on the functioning of not only the economy, but it is also closely linked to the health sector, and thus affects the level and quality of life of societies. In this context it becomes particularly important to seek solutions that will ensure the free flow of knowledge and access to highly specialized techniques, which in turn have a positive impact on the health of citizens. Analysis of the functioning of the pharmaceutical clusters is based on case study cluster Nutribiomed. The results achieved in many areas of activity confirm the legitimate use of the structure of the group of highly specialized industry, which is the drug market and indicates a number of benefits associated with the operation as part of its structure.

  11. Decreased coenzyme Q10 concentration in plasma of children with cystic fibrosis

    NARCIS (Netherlands)

    Oudshoorn, J.H.; Lecluse, A.L.Y.; Berg, R. van den; Vaes, W.H.J.; Laag, J. van der; Houwen, R.H.J.

    2006-01-01

    OBJECTIVES: Coenzyme Q10 (CoQ10) is an effective lipophilic antioxidant and protects against lipid peroxidation by scavenging radicals. Patients with cystic fibrosis generally have fat malabsorption; thus, we hypothesized that overall plasma CoQ10 concentration in pediatric patients with cystic

  12. Basic pharmaceutical technology

    OpenAIRE

    Angelovska, Bistra; Drakalska, Elena

    2017-01-01

    The lecture deals with basics of pharmaceutical technology as applied discipline of pharmaceutical science, whose main subject of study is formulation and manufacture of drugs. In a broad sense, pharmaceutical technology is science of formulation, preparation, stabilization and determination of the quality of medicines prepared in the pharmacy or in pharmaceutical industry

  13. [Early achievements of the Danish pharmaceutical industry-6 Pharmacia].

    Science.gov (United States)

    Grevsen, Jørgen V; Kruse, Edith; Kruse, Poul R

    2014-01-01

    The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 6 deals with products from A/S Pharmacia. A/S Pharmacia was established in Copenhagen in 1922 as a Danish limited company by the enterprising pharmacist Edward Jacobsen. Pharmacia was not Jacobsen's first pharmaceutical company as previously he had established a pharmaceutical agency already in 1913 which in 1919 was reorganized to a limited company by the name of A/S Edward Jacobsen. This agency was later extended to include a production of generics. Jacobsen remained the co-owner and manager of Pharmacia until 1934 where he resigned and established another company, A/S Ejco, for the manufacture of generics. It is worth mentioning that already in 1911 a Swedish pharmaceutical company was established named AB Pharmacia. Today we do not know whether Edward Jacobsen knew about this Swedish company. Later on in 1936 AB Pharmacia and A/S Pharmacia made a contract concerning mutual market sharing, and a research cooperation was brought about between the two companies which resulted in an increase of turnover for A/S Pharmacia. In 1955 the cooperation between the two companies was increased as the Swedish company joined as principal shareholder with the purpose of continuing and developing the Danish company as an independent pharmaceutical company with its own research and development as well as manufacture, control and marketing. Therefore Pharmacia in Denmark was able to establish a synthesis factory in Koge and move the domicile to new premises in Hillered. In 1993 Pharmacia was presented in a printed matter as "The largest Nordic pharmaceutical company" as a result of the merger between the Swedish Kabi Pharmacia, formerly established by a merger between Kabi Vitrum and AB Pharmacia, and the Italian Farmitalia Carlo Erba. Only two years later in 1995 Pharmacia merged with the American pharmaceutical company The

  14. Protective Effect of Coenzyme Q10 on Methamphetamine-Induced Apoptosis in Adult Male Rats

    Directory of Open Access Journals (Sweden)

    Fatemeh Gholipour

    2017-06-01

    Full Text Available Background: The negative consequence of methamphetamine abuse is due to neuropathologic changes in the brain, which reduces dopaminergic neurons and result in damage to different brain areas. Neurotoxicity induced by methamphetamine increases the oxidative stress and associated with neuronal apoptosis. The role of the antioxidant coenzyme Q10 probably produces its neuroprotective effects. Therefore, the purpose of the present study was to examine the protective effect of coenzyme Q10 on methamphetamine-induced apoptosis in adult male rats.Materials and Methods: Fifty Wistar eight-week adult rats randomly divided into 5 groups: Healthy control, methamphetamine injection (Meth, methamphetamine injection and CoQ10 5mg/kg treatment (Meth+Post CoQ10 5mg/kg, methamphetamine injection and CoQ10 10mg/kg treatment (Meth+Post CoQ10 10mg/kg, methamphetamine injection and CoQ10 20mg/kg treatment (Meth+Post CoQ10 20mg/kg. Methamphetamine with a purity of 96% with a dosage of 20 mg/kg was injected Intraperitoneal. Coenzyme Q10 for three treatment groups was injected intraperitoneally for 14 days in a dosage of 5, 10 and 20 mg/kg/day. The protein expressions of Baxand Bcl2 were evaluated by western blotting technique.Results: Bax protein expression was significantly lower in Meth+Post CoQ10 5mg/kg (p=0.010 and so Meth+Post CoQ10 10mg/kg (p=0.004 comparing to Meth group. In addition, Bcl2 protein expression was significantly higher in Meth+Post CoQ10 5mg/kg comparing to Meth group (p=0.018. However, there were no significant differences between control and CoQ10 treatment groups. Bax/Bcl2 ratio was significantly lower in Meth+Post CoQ10 5mg/kg (p=0.005, Meth+Post CoQ10 10mg/kg (p=0.008 and Meth+Post CoQ10 20mg/kg (p=0.044 comparing to Meth group.Conclusion: We suggest that CoQ10 reduces the methamphetamine-induced apoptosis in the striatum of the rats through the reduction of apoptotic factors and increase of anti-apoptotic pathways.

  15. Growth of the Asian health-care market: global implications for the pharmaceutical industry.

    Science.gov (United States)

    Epstein, Richard J

    2007-10-01

    The global economy is being transformed by an explosion of information unleashed by the internet, the digital revolution, communications and increased international mobility. This transformation is manifesting in many ways, including rapid development of countries such as China, commoditization of public services, mobilization of workforces, shifting of market control from suppliers to consumers, interlinked rises in product demand and customer expectations, and problems regulating international business competition. As Asia is home to half of the world's population, and offers both a large relatively low-cost workforce in some countries and a potentially huge retail market, this region could be central to the future of the global economy. Like other industries, the pharmaceutical industry faces a new array of Asia-specific opportunities and challenges. Success in meeting these challenges will go to those pharmaceutical companies that best understand the unique strengths and constraints of Asia's diverse cultures, talents and markets.

  16. Vermicomposting of herbal pharmaceutical industry waste: earthworm growth, plant-available nutrient and microbial quality of end materials.

    Science.gov (United States)

    Singh, Deepika; Suthar, Surindra

    2012-05-01

    Efforts were made to decompose herbal pharmaceutical industrial waste (HPIW) spiked with cow dung (CD) using Eisenia fetida. A total of five vermibeds: T(1) - HPIW (0%+CD 100%, control), T(2) - HPIW (25%), T(3) - HPIW (50%), T(4) - HPIW (75%) and T(5) - HPIW (100%) were used for vermicomposting. The changes in biology and chemistry of vermibeds were measured after ten days interval. E. fetida showed high growth and cocoon production rate in all vermibeds. The vermicomposted material contained great population of fungi 6.0-40.6 (CFU × 10(5)g(-1)), bacteria 220-1276.0 (CFU × 10(8)g(-1)) and actinomycetes 410.0-2962.0 (CFU × 10(5)g(-1)) than initial material. Vermicomposted material was rich in plant-available forms of nutrients (N-NO(3)(-),PO(4)(3-),available K and SO(4)(-2)). Results suggested that noxious industrial waste can be converted into valuable product for sustainable soil fertility programme. Copyright © 2012 Elsevier Ltd. All rights reserved.

  17. The development of a self-sufficient pharmaceutical industry in autarchic Spain: between need, utopia and fracoist propaganda

    Directory of Open Access Journals (Sweden)

    Raúl Rodríguez Nozal

    2017-06-01

    Full Text Available The history of the Spanish pharmaceutical industry is conditioned by its ascription to a Mediterranean model, with small economic impact and a high presence of artisan and professional elements. The industry of organic and fermentative raw materials did not appear until the Franco dictatorship. During the autarchy period, an interest to stimulate the sector seems to have arose: first, by continuing the long going investment on industries of natural products to obtain medical active principles, hence preventing their import; secondly, aimed at long term, by establishing an integral organic chemistry industry to obtain drugs from coal; and finally, by promoting the development of an industry of penicillin synthesis. However, there were a number of elements that hindered the development of the chemical-pharmaceutical industry, including the inherent limitations of the autarchic policies, the excessive number of laboratories and commercialized products, the poor capitalization and lack of research programs of these companies and the insufficient technical and scientific abilities required for these activities.

  18. Expectations and satisfaction of academic investigators in nonclinical collaboration with the pharmaceutical industry.

    Science.gov (United States)

    Amiri, Marjan; Michel, Martin C

    2015-06-01

    In light of a growing role of research collaborations between academia and the pharmaceutical industry, we have explored expectations and experience of academic investigators with preclinical collaborations. Researchers from Western Europe, North America, and Japan with preclinical publications in the obstructed airways or diabetes fields were invited to anonymously participate in a web-based survey. A total of 134 investigators (28 % of invitees) participated in the two sequentially performed surveys with similar responses in both therapeutic areas. A secondary but prespecified subgroup analysis was based on region of residence, gender, and career level of the investigator. Across all groups, responders considered freedom to publish, obtaining funding and obtaining compounds to be the most important objectives of nonclinical collaborations with the pharmaceutical industry, whereas cultivating professional relationships, getting external scientific input, direct relationship to disease treatment, and involvement with drug development were less important. Among eight attributes of the primary contact person in the company, trustworthiness ranked highest, followed by a collaborative spirit and transparent information sharing; supportiveness, scientific qualification, accessibility, and timeliness of responses ranked lower, and friendliness, lowest. Related to their most recent collaboration, investigators also expressed the highest level of satisfaction with the trustworthiness attribute. On the other hand, the process of reaching a contract was often considered too long and difficult, for which both university and company legal departments were reported as culprits. We conclude that academic researchers are generally satisfied with their preclinical collaboration with the pharmaceutical industry but look for improved contracting procedures.

  19. Value of pharmaceuticals: ensuring the future of research and development.

    Science.gov (United States)

    Serajuddin, Hamida K; Serajuddin, Abu T M

    2006-01-01

    To analyze the current situation under which the pharmaceutical industry is criticized for the production of drugs with potential adverse effects, the high prices of medicines, and aggressive marketing practices, and to provide a proposal to rectify the situation. Published books, pharmaceutical journals, Web of Science database using the search terms pharmaceutical, research, development, marketing, cost, and the Food and Drug Administration (FDA) Web site. Most breakthroughs in the treatment of diseases and prolongation of lives have come about through pharmaceuticals discovered and developed by the pharmaceutical industry. While the process of discovering and developing new pharmaceuticals is lengthy, costly, and lacking any assurance of success, investment in research and development by the U.S. pharmaceutical industry has increased progressively, reaching 51.3 billion dollars in 2005. Yet the annual number of FDA approvals of new molecular entities (NMEs) has gradually decreased over the past 10 years. Additionally, a large part of the patent life of a successful NME is consumed during this lengthy development phase. Few businesses, if any, have such long product gestation lives and risks. For these reasons, the pharmaceutical industry is often in a rush to recoup its investment before the product's patent expires, and this is the root cause of many criticisms against the pharmaceutical industry. To rectify the current situation, a new system is proposed under which innovator pharmaceutical companies would be allowed royalties for their products after the expiration of patents, in a manner similar to the way in which other intellectual properties (such as books, music, films) are protected by copyright. Such a system would allow pharmaceutical companies to continue research on new pharmaceutical products unimpeded by the patent clock. Given appropriate legislative or other facilitatory actions, a royalty-based system for the marketing of generic products after

  20. Hepatoprotective effect of taurine and coenzyme Q10 and their ...

    African Journals Online (AJOL)

    CoQ10) for mitigation of acrylamide- induced oxidative damage. . Method: Acrylamide (AA), TA and CoQ10 were administered orally to rats for 2 and 4 weeks. Sixty albino rats of either sex weighing 200 ± 5 were randomly divided into five groups; ...

  1. 7Q10 flows for SRS streams

    International Nuclear Information System (INIS)

    Chen, K.F.

    1996-01-01

    The Environmental Transport Group of the Environmental Technology Section was requested to predict the seven-day ten-year low flow (7Q10 flow) for the SRS streams based on historical stream flow records. Most of the historical flow records for the SRS streams include reactor coolant water discharged from the reactors and process water released from the process facilities. The most straight forward way to estimate the stream daily natural flow is to subtract the measured upstream reactor and/or facility daily effluents from the measured downstream daily flow. Unfortunately, this method does not always work, as indicated by the fact that sometimes the measured downstream volumetric flow rates are lower than the reactor effluent volumetric flow rates. For those cases that cannot be analyzed with the simple subtracting method, an alternative method was used to estimate the stream natural flows by statistically separating reactor coolant and process water flow data. The correlation between the calculated 7Q10 flows and the watershed areas for Four Mile Branch and Pen Branch agrees with that calculated by the USGS for Upper Three Runs and Lower Three Runs Creeks. The agreement between these two independent calculations lends confidence to the 7Q10 flow calculations presented in this report

  2. Business Ethics and CSR in Pharmaceutical Industry in the Czech Republic and Hungary?

    Directory of Open Access Journals (Sweden)

    Markéta Lőrinczy

    2015-01-01

    Full Text Available How do business ethics and CSR form part of pharmaceutical business in the Czech Republic and Hungary? The question was analyzed through empirical studies where surveys were the main tool. The research investigated business ethics, CSR, ethical code, ethical involvement of employees as factors that might be important to achieve ethical behaviour in the pharmaceutical industry. Results showed that, with 69.4% response rate, that Czech and Hungarian original companies are more towards ethical behaviour and the employees know more about the organization they work for. The data were compared with parametric statistical analysis based on Mann-Whitney U calculator.

  3. Creating knowledge structures in the pharmaceutical industry: the increasing significance of virtual organisation.

    Science.gov (United States)

    Salazar, A; Howells, J

    2000-01-01

    This paper explores the specific trend and challenges facing the pharmaceutical industry regarding the exploitation of Internet e-commerce technology and virtual organisation to develop and maintain competitive advantage. There are two important facets of the current trend. One is the rapid development of a complex network of alliances between the established pharmaceutical companies and the specialised biotechnology company start-ups. The other is the rapid growth of internet e-commerce companies dedicated to developing specialised technological platforms for acquiring and selling genetic and biochemical knowledge. The underlying challenge is how big pharmaceutical companies can emulate some of the innovation processes of smaller biotechnology company start-ups, and how they can appropriate and applied new technological knowledge on the development of new drugs. Pharmaceutical companies in order to retain competitive advantage need to continuously monitor all aspects of knowledge management with regard to the R&D and manufacturing process (as well as customer management and marketing). Technological change and organisational restructuring should be aimed at boosting the capacity of large firms to innovate rapidly.

  4. Potential role of coenzyme Q10 in health and disease conditions

    Directory of Open Access Journals (Sweden)

    Rodick TC

    2018-02-01

    Full Text Available Taylor C Rodick,1 Donna R Seibels,2 Jeganathan Ramesh Babu,1 Kevin W Huggins,1 Guang Ren,3 Suresh T Mathews2 1Department of Nutrition, Dietetics, & Hospitality Management, Auburn University, Auburn, 2Department of Nutrition and Dietetics, Samford University, 3Medicine-Endocrinology, Diabetes & Metabolism, University of Alabama at Birmingham, Birmingham, AL, USA Abstract: Coenzyme Q10 (CoQ10, an endogenously produced compound, is found in all human cells. Within the mitochondria, it plays a substantial role in energy production by acting as a mobile electron carrier in the electron transport chain. Outside the mitochondria, it acts as an excellent antioxidant by sequestering free radicals and working synergistically with other antioxidants, including vitamin E. Dietary contribution is limited, making endogenous production the primary source for optimal function. Now widely available as an over-the-counter supplement, CoQ10 has gained attention for its possible therapeutic use in minimizing the outcomes of certain metabolic diseases, notably cardiovascular disease, diabetes, neurodegenerative disease, and cancer. Research has shown positive results in subjects supplemented with CoQ10, especially in relation to upregulating antioxidant capability. Emerging research suggests beneficial effects of CoQ10 supplementation in individuals on statin medications. CoQ10 supplementation in individuals participating in strenuous exercise seems to exert some beneficial effects, although the data are conflicting with other types of physical activity. This broad review of current CoQ10 literature, while outlining its physiological/functional significance in health and disease conditions, also offers a dietitian’s perspective on its potential use as a supplement in the promotion of health and management of disease conditions. Keywords: coenzyme Q, antioxidant, oxidative stress, dietary supplement, statin

  5. Organic Colouring Agents in the Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Šuleková M.

    2017-09-01

    Full Text Available Food dyes are largely used in the process of manufacturing pharmaceutical products. The aim of such a procedure is not only to increase the attractiveness of products, but also to help patients distinguish between pharmaceuticals. Various dyes, especially organic colouring agents, may in some cases have a negative impact on the human body. They are incorporated into pharmaceutical products including tablets, hard gelatine capsules or soft gelatine capsules, lozenges, syrups, etc. This article provides an overview of the most widely used colouring agents in pharmaceuticals, their characteristics and the EU legislation which regulates their use.

  6. Cold-Induced Ascites in Broilers: Effects of Vitamin C and Coenzyme Q10

    Directory of Open Access Journals (Sweden)

    MH Nemati

    Full Text Available ABSTRACT We hypothesized that the supplementation of vitamin C (Vit. C and coenzyme Q10 (CoQ10 alone or in combination could reduce the negative effects of cold stress in broilers. Four hundred male chicks were exposed for 24 h to cold stress (15 ºC starting from 15d of age, while a positive control group (PC, 100 birds was kept under normal temperature condition. The experimental groups under cold stress (four treatments in 5 replicates of 20 birds were: negative control (NC, basal diet, Vit. C (basal diet + 300 mg/kg Vit. C, CoQ10 (basal diet + 40 mg/kg CoQ10 and Vit. C plus CoQ10 (basal diet + Vit. C+ CoQ10at above mentioned doses. Vit. C or CoQ10 supplementation were restored (p<0.01 performance and lowered (p<0.01 ascites mortality. Blood hematocrit and hemoglobin concentration were decreased (p<0.01 to the level comparable to PC by Vit. C supplementation. Lower plasma concentrations of thyroxin (T4 and higher triiodothyronine (T3 were observed in NC birds (p<0.01 and were not affected by Vit. C or CoQ10. In conclusion, supplementation of Vit. C or CoQ10 in diet of broilers under cold stress conditions resulted improved performance parameters (body weight and feed conversion ratio and ascites related traits (low red blood cell count, hematocrit, T3, and heart weights and high T4. No additional benefit was observed by combination of Vit. C and CoQ10.

  7. Bioavailability enhancement of coenzyme Q10: an extensive review of patents.

    Science.gov (United States)

    Beg, Sarwar; Javed, Shamama; Kohli, Kanchan

    2010-11-01

    Coenzyme Q10 (CoQ10) is a major antioxidant principle found in human body which plays a vital role in maintaining several biochemical pathways of body. It acts as a potential mediator in transferring electrons in oxidoreductive reactions of electron transport chain. Chemically, it is a basic quinone containing moiety having a large and high molecular weight structure. Deficiency of this in body leads to several potential disorders like dysfunctions in cellular energetics, neurological degeneration, higher oxidative stress induced damage, breast cancer etc. The high molecular weight and lipophilicity of CoQ10 makes it poorly water soluble and consequently leads to low systemic availability. Several advancements have been made to enhance the bioavailability of CoQ10 using various approaches like size reduction, solubility enhancement (by solid dispersion, prodrug, complexation, ionization) and use of novel drug carriers such as liposomes, microspheres, nanoparticles, nanoemulsions and self-emulsifying system. The primary objective of the present review is to assemble patents representing the various approaches used for enhancement of CoQ10 bioavailability.

  8. Nedsat koenzym Q10 kan være årsag til statinassocieret myopati

    DEFF Research Database (Denmark)

    Nielsen, Mette Lundgren; Pareek, Manan; Henriksen, Jan Erik

    2011-01-01

    Statin treatment can cause muscular side effects. It has been suggested that the mechanism is reduced synthesis of coenzyme Q10 (coQ10) and a subsequent dysfunction of the respiratory chain. A literature review resulted in insufficient evidence supporting this theory. It is uncertain whether...... intramuscular levels of coQ10 and mitochondrial function are affected by statin therapy and whether the symptoms of myopathy can be alleviated with coQ10 supplementation. Nevertheless, due to a favourable safety profile, coQ10 can be tested in patients whose muscular symptoms cannot be managed otherwise....

  9. Preformed β-amyloid fibrils are destabilized by coenzyme Q10 in vitro

    International Nuclear Information System (INIS)

    Ono, Kenjiro; Hasegawa, Kazuhiro; Naiki, Hironobu; Yamada, Masahito

    2005-01-01

    Inhibition of the formation of β-amyloid fibrils (fAβ), as well as the destabilization of preformed fAβ in the CNS, would be attractive therapeutic targets for the treatment of Alzheimer's disease (AD). We reported previously that nordihydroguaiaretic acid (NDGA) and wine-related polyphenol, myricetin (Myr), inhibit fAβ formation from Aβ and destabilize preformed fAβ in vitro. Using fluorescence spectroscopic analysis with thioflavin T and electron microscopic studies, we examined the effects of coenzyme Q 10 (CoQ 10 ) on the formation, extension, and destabilization of fAβ at pH 7.5 at 37 deg C in vitro. We next compared the anti-amyloidogenic activities of CoQ 10 with NDGA and Myr. CoQ 10 dose-dependently inhibited fAβ formation from amyloid β-peptide (Aβ), as well as their extension. Moreover, it destabilized preformed fAβs. The anti-amyloidogenic effects of CoQ 10 were slightly weaker than those of NDGA and Myr. CoQ 10 could be a key molecule for the development of therapeutics for AD

  10. Does brand differentiate pharmaceuticals?

    Science.gov (United States)

    Bednarik, Josef

    2005-12-01

    Role of marketing in pharmaceutical industry is increasing and inspiration by successful brands known from consumer goods market influenced pharmaceutical companies enough to switch their attention to branding initiatives. Still there is little evidence that pharmaceutical brands represent anything more than product only. This study aims to explore the area of branding in pharmaceutical industry. Central hypothesis of the research has been that brand and its emotional content differentiate pharmaceuticals as well as rational data derived from clinical studies. It has been tested by extensive review of available literature as well as by primary research focused on drivers of physicians' attitudes towards products and their influence on prescribing behavior. The research has been conducted in the sample of psychiatrists in the Czech Republic. No evidence about pharmaceutical brand exceeding value of product has been found in reviewed literature. Nevertheless, the primary research conducted in the sample of Czech psychiatrists indicates that emotional brand in pharmaceutical industry exists and enables author to draw a model of Customer/product life cycle that describes likely impact of functional, emotional and self-expressive benefits throughout pharmaceutical product's market presence. Pharmaceutical brand is likely to develop differently than the same of consumer goods products--it seems to be built predominantly on long-term positive experience. Marketing role in this process should lie in finding relevant product position and building brand identity compliant with real product capabilities.

  11. Heterogeneous batch distillation processes for waste solvent recovery in pharmaceutical industry

    OpenAIRE

    Rodriguez-Donis, Ivonne; Gerbaud, Vincent; Arias-Barreto, Alien; Joulia, Xavier

    2009-01-01

    A summary about our experiences in the introduction of heterogeneous entrainers in azeotropic and extractive batch distillation is presented in this work. Essential advantages of the application of heterogeneous entrainers are showed by rigorous simulation and experimental verification in a bench batch distillation column for separating several azeotropic mixtures such as acetonitrile – water, n hexane – ethyl acetate and chloroform – methanol, commonly found in pharmaceutical industry.

  12. A randomized trial of coenzyme Q10 in patients with confirmed statin myopathy.

    Science.gov (United States)

    Taylor, Beth A; Lorson, Lindsay; White, C Michael; Thompson, Paul D

    2015-02-01

    Coenzyme Q10 (CoQ10) supplementation is the most popular therapy for statin myalgia among both physicians and patients despite limited and conflicting evidence of its efficacy. This study examined the effect of coenzyme Q10 (CoQ10) supplementation on simvastatin-associated muscle pain, muscle strength and aerobic performance in patients with confirmed statin myalgia. Statin myalgia was confirmed in 120 patients with prior symptoms of statin myalgia using an 8-week randomized, double-blind crossover trial of simvastatin 20 mg/d and placebo. Forty-one subjects developed muscle pain with simvastatin but not with placebo and were randomized to simvastatin 20 mg/d combined with CoQ10 (600 mg/d ubiquinol) or placebo for 8 weeks. Muscle pain (Brief Pain Inventory [BPI]), time to pain onset, arm and leg muscle strength, and maximal oxygen uptake (VO2max) were measured before and after each treatment. Serum CoQ10 increased from 1.3 ± 0.4 to 5.2 ± 2.3 mcg/mL with simvastatin and CoQ10, but did not increase with simvastatin and placebo (1.3 ± 0.3 to 0.8 ± 0.2) (p pain severity and interference scores increased with simvastatin therapy (both p muscle strength or VO2max with simvastatin with or without CoQ10 (all p > 0.10). Marginally more subjects reported pain with CoQ10 (14 of 20 vs 7 of 18; p = 0.05). There was no difference in time to pain onset in the CoQ10 (3.0 ± 2.0 weeks) vs. placebo (2.4 ± 2.1 wks) groups (p = 0.55). A similar lack of CoQ10 effect was observed in 24 subjects who were then crossed over to the alternative treatment. Only 36% of patients complaining of statin myalgia develop symptoms during a randomized, double-blind crossover of statin vs placebo. CoQ10 supplementation does not reduce muscle pain in patients with statin myalgia. Trial RegistrationNCT01140308; www.clinicaltrials.gov. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  13. Gamma radiodecontamination of natural products uses in Cuban pharmaceutical industry

    International Nuclear Information System (INIS)

    Rodriguez, M.; Lopez, M.; Guerra, M.; Lastra, H.; Prieto, E.; Padron, E.

    1997-01-01

    The aim of the present paper was to carry out the gamma radiodecontamination of industrial productions from there medicinal plant species (C. officinalis, P. incarta and M. recuttia) and two pharmaceuticals forms (S. platensis and bee pollen tabs) which presented high levels of microbiological count. Adequate irradiation doses calculated for each product were used in decontamination. The results obtained showed the effectiveness of the process in the elimination of microbial contamination from theses natural products. No changes in nutritional constituents or physico-chemical properties were observed

  14. Determinants of FDI Localization in China: A County-Level Analysis for the Pharmaceutical Industry.

    Science.gov (United States)

    Li, Su; Angelino, Antonio; Yin, Haitao; Spigarelli, Francesca

    2017-08-30

    Foreign direct investments (FDIs) have been widely recognized as a crucial feature of the Chinese industrial development process. Over the past decades, China has been attracting huge amounts of inward FDIs as a consequence of both spontaneous market dynamics and place-based preferential policies at the sub-national level. However, the Chinese market exhibits large dissimilarities in terms of FDI localization across territories that are worth investigating at a more disaggregated level. In this regards, our study explores the determinants of attraction of inward FDIs in China, at the county level. It focuses on the pharmaceutical industry and attempts to assess whether factors related to location advantages, agglomeration dynamics, information cost effects and environmental regulation costs affect foreign firms' localization choices as well as invested amounts in that location. By means of discrete choice models, our paper confirms the findings of the prevalent literature about the positive effects of location advantages on pharmaceutical FDI attraction. Different from our expectations, a higher proportion of foreign enterprises do not stimulate significant effects on FDI localization, while preferential policies and sectoral agglomeration are positively correlated with the localization of pharmaceutical foreign firms. Finally, our results suggest that investing firms tend to avoid areas with strict environment regulation.

  15. The epiphany of data warehousing technologies in the pharmaceutical industry.

    Science.gov (United States)

    Barrett, J S; Koprowski, S P

    2002-03-01

    The highly competitive pharmaceutical industry has seen many external changes to its landscape as companies consume each other increasing their pipelines while removing redundant functions and processes. Internally, companies have sought to streamline the discovery and development phases in an attempt to improve candidate selection and reduce the time to regulatory filing. In conjunction with efforts to screen and develop more compounds faster and more efficiently, database management systems (DBMS) have been developed for numerous groups supporting various R&D efforts. An outgrowth of DBMS evolution has been the birth of data warehousing. Often confused with DBMS, data warehousing provides a conduit for data residing across platforms, networks, and in different data structures. Through the use of metadata, the warehouse establishes connectivity of varied data stores (operational detail data, ODD) and permits identification of data ownership, location and transaction history. This evolution has closely mirrored and in some ways been driven by the electronic submission (formerly CANDA). The integration of the electronic submissions and document management with R&D data warehousing initiatives should provide a platform by which companies can address compliance with 21 CFR Part 11. Now more than ever "corporate memory" is being extended to the data itself. The when, why and how of successes and failures are constantly being probed by R&D management teams. The volume of information being generated by today's pharmaceutical companies requires mining of historical data on a routine basis. Data warehousing represents a core technology to assist in this endeavor. New initiatives in this field address the necessity of data portals through which warehouse data can be web-enabled and exploited by diverse data customers both internal and external to the company. The epiphany of data warehousing technologies within the pharmaceutical industry has begun and promises to change

  16. Pharmaceutical product cross-contamination: industrial and clinical ...

    African Journals Online (AJOL)

    problems. Pharmaceutical product cross-contamination is a serious problem which has been detected as an obstacle ... In the pharmaceutical care of patients in developed countries, cross-contamination ..... neonatal intensive care units.

  17. Accounting- versus economic-based rates of return: implications for profitability measures in the pharmaceutical industry.

    Science.gov (United States)

    Skrepnek, Grant H

    2004-01-01

    Accounting-based profits have indicated that pharmaceutical firms have achieved greater returns relative to other sectors. However, partially due to the theoretically inappropriate reporting of research and development (R&D) expenditures according to generally accepted accounting principles, evidence suggests that a substantial and upward bias is present in accounting-based rates of return for corporations with high levels of intangible assets. Given the intensity of R&D in pharmaceutical firms, accounting-based profit metrics in the drug sector may be affected to a greater extent than other industries. The aim of this work was to address measurement issues associated with corporate performance and factors that contribute to the bias within accounting-based rates of return. Seminal and broadly cited works on the subject of accounting- versus economic-based rates of return were reviewed from the economic and finance literature, with an emphasis placed on issues and scientific evidence directly related to the drug development process and pharmaceutical industry. With international convergence and harmonization of accounting standards being imminent, stricter adherence to theoretically sound economic principles is advocated, particularly those based on discounted cash-flow methods. Researchers, financial analysts, and policy makers must be cognizant of the biases and limitations present within numerous corporate performance measures. Furthermore, the development of more robust and valid economic models of the pharmaceutical industry is required to capture the unique dimensions of risk and return of the drug development process. Empiric work has illustrated that estimates of economic-based rates of return range from approximately 2 to approximately 11 percentage points below various accounting-based rates of return for drug companies. Because differences in the nature of risk and uncertainty borne by drug manufacturers versus other sectors make comparative assessments

  18. Autism spectrum disorder with microdeletion 10q26 by subtelomere FISH

    Directory of Open Access Journals (Sweden)

    Tonk VS

    2011-05-01

    Full Text Available Vijay S Tonk1,2, Golder N Wilson11Department of Pediatrics, Texas Tech University Health Sciences Center, Lubbock, TX, USA; 2Departments of Pathology, Obstetrics and Gynecology, Texas Tech University Health Sciences Center, Lubbock, TX, USAAbstract: An 11-year-old female with early feeding problems, mild motor delays, normal speech, subtle facial changes, social difficulties, anxiety and a diagnosis of Asperger disorder was found to have deletion of 10q26.3 by subtelomere fluorescent in situ hybridization (stF analysis. Our patient and others with 10q26 aneuploidy add this region to 11 other autism susceptibility loci qualified by converging genome linkage/association, high resolution chromosome, and mutation studies in our review. We summarize these loci and the current spectrum of terminal 10q deletion cases.Keywords: autism disorder, Asperger disorder, subtelomere FISH, microarray analysis, 10q26 deletion, gene changes in autism

  19. Coenzyme Q10 Supplementation and Oocyte Aneuploidy in Women Undergoing IVF-ICSI Treatment

    Directory of Open Access Journals (Sweden)

    Yaakov Bentov

    2014-01-01

    Full Text Available Background The age-related reduction in live-birth rate is attributed to a high rate of aneuploidy and follicle depletion. We showed in an animal model that treatment with Coenzyme Q10 (CoQ10 markedly improved reproductive outcome. The aim of this study was to compare the post-meiotic oocyte aneuploidy rate in in vitro fertilization (IVF and intra cytoplasmic sperm injection (ICSI patients treated with CoQ10 or placebo. Methods We conducted a double blind placebo controlled randomized trial that included IVF-ICSI patients 35-43 years of age. The patients were treated with either 600 mg of CoQ10 or an equivalent number of placebo caps. We compared the post-meiotic aneuploidy rate using polar body biopsy (PBBX and comparative genomic hybridization (CGH. According to the power calculation, 27 patients were needed for each arm. Results Owing to safety concerns regarding the effects of polar body biopsy on embryo quality and implantation, the study was terminated before reaching the target number of participants. A total of 39 patients were evaluated and randomized (17 CoQ10, 22 placebo, 27 were given the study medication (12 CoQ10, 15 placebo, and 24 completed an IVF-ICSI cycle including PBBX and embryo transfer (10 CoQ10, 14 placebo. Average age, base line follicle stimulating hormone (FSH, peak estradiol and progesterone serum level, as well as the total number of human menopausal gonadotropin (hMG units–-did not differ between the groups. The rate of aneuploidy was 46.5% in the CoQ10 group compared to 62.8% in the control. Clinical pregnancy rate was 33% for the CoQ10 group and 26.7% for the control group. Conclusion No significant differences in outcome were detected between the CoQ10 and placebo groups. However, the final study was underpowered to detect a difference in the rate of aneuploidy.

  20. Nanotechnology tools in pharmaceutical R&D

    OpenAIRE

    Challa S.S.R. Kumar

    2010-01-01

    Nanotechnology is a new approach to problem solving and can be considered as a collection of tools and ideas which can be applied in pharmaceutical industry. Application of nanotechnology tools in pharmaceutical R&D is likely to result in moving the industry from ‘blockbuster drug’ model to ‘personalized medicine’. There are compelling applications in pharmaceutical industry where inexpensive nanotechnology tools can be utilized. The review explores the possibility of categorizing various nan...

  1. CoQ10 plasmatic levels in breast-fed infants compared to formula-fed infants.

    Science.gov (United States)

    Compagnoni, G; Giuffrè, B; Lista, G; Mosca, F; Marini, A

    2004-01-01

    Coenzyme Q10 has been recognized as an important antioxidant factor besides its main role in bioenergetic metabolism. CoQ10 tissue levels depend both on exogenous dietetic intake and on endogenous biosynthesis, as this compound can be partly synthesized in human cells. Q10 plasma levels reflect the tissue content of the coenzyme and can be used to evaluate the presence of this compound in the human organism. Aim of the study was to measure CoQ10 plasmatic levels in a newborn breast-fed population and to compare them to CoQ10 levels in a newborn formula-fed population in order to verify whether changes in CoQ10 plasmatic contents could be related to a different dietetic intakes. We measured CoQ10 plasmatic levels in 25 healthy term neonates with different dietetic intakes: 15 breast-fed and 10 bottle-fed with a common infant formula. These infants were evaluated prospectively during the first month of life. The analyses were performed on the mothers' blood samples and cord blood samples at the time of delivery, then on infants at 4 and 28 days of age. Our results showed markedly reduced Q10 levels in cord blood samples compared to maternal Q10 plasmatic levels at the time of delivery, suggesting placental impermeability towards this molecule or increased fetal utilization during labor and delivery. At 4 days of age Q10 levels had increased in both groups of neonates, but significantly more in breast-fed infants compared to formula-fed babies (p <0.05). At 4 weeks of age no significant changes occurred in breast-fed infants, while values increased significantly in formula-fed infants (p <0.05). The content of Q10 in breast milk samples was lower than in infant formula. The results of this study show that CoQ10 plasmatic levels are at least partly influenced by the exogenous dietetic supply.

  2. Plasma coenzyme Q10 levels in type 2 diabetic patients with retinopathy

    Science.gov (United States)

    Ates, Orhan; Bilen, Habip; Keles, Sadullah; Alp, H. Hakan; Keleş, Mevlüt Sait; Yıldırım, Kenan; Öndaş, Osman; Pınar, L. Can; Civelekler, Mustafa; Baykal, Orhan

    2013-01-01

    AIM To determine the relationship between proliferative diabetic retinopathy (PDRP) and plasma coenzyme Q10(CoQ10) concentration. METHODS Patients with type 2 diabetes and PDRP were determined to be the case group (n=50). The control group was consist of healthy individuals (n=50). Plasma CoQ10 and malondialdehyde (MDA) levels were measured in both groups. RESULTS Ubiquinone-10 (Coenzyme Q10) levels in PDRP and control subjects are 3.81±1.19µmol/L and 1.91±0.62µmol/L, respectively. Plasma MDA levels in PDRP and control subjects were 8.16±2µmol/L and 3.44±2.08µmol/L, respectively. Ratio of Ubiquinol-10/ubiquinone-10 in PDRP and control subjects were 0.26±0.16 and 1.41±0.68, respectively. CONCLUSION The ratio of ubiquinol-10/ubiquinone-10 is found lower in patients with PDRP. High levels of plasma ubiquinol-10/ubiquinone-10 ratio indicate the protective effect on diabetic retinopathy. PMID:24195048

  3. Plasma coenzyme Q10 levels in type 2 diabetic patients with retinopathy

    Directory of Open Access Journals (Sweden)

    Orhan Ates

    2013-10-01

    Full Text Available AIM: To determine the relationship between proliferative diabetic retinopathy (PDRP and plasma coenzyme Q10(CoQ10 concentration.METHODS: Patients with type 2 diabetes and PDRP were determined to be the case group (n=50. The control group was consist of healthy individuals (n=50. Plasma CoQ10 and malondialdehyde (MDA levels were measured in both groups.RESULTS: Ubiquinone-10 (Coenzyme Q10 levels in PDRP and control subjects are 3.81±1.19µmol/L and 1.91±0.62µmol/L, respectively. Plasma MDA levels in PDRP and control subjects were 8.16±2µmol/L and 3.44±2.08µmol/L, respectively. Ratio of Ubiquinol-10/ubiquinone-10 in PDRP and control subjects were 0.26±0.16 and 1.41±0.68, respectively.CONCLUSION:The ratio of ubiquinol-10/ubiquinone-10 is found lower in patients with PDRP. High levels of plasma ubiquinol-10/ubiquinone-10 ratio indicate the protective effect on diabetic retinopathy.

  4. Impact analysis of the implemented quality management system on business performances in pharmaceutical-chemical industry in Serbia

    Directory of Open Access Journals (Sweden)

    Marinković Valentina D.

    2013-01-01

    Full Text Available International quality management standard (QMS ISO 9001 became widely accepted as a framework for product and/or services quality improvement. There are recent research conducted in order to define relationships and effects between the applied QMS and financial and/or non-financial business parameters. The effects of the applied pharmaceutical quality system (PQS on the business performances in Serbian pharmaceutical-chemical industry are analyzed in this paper using multivariate linear regression analysis. The empirical data were collected using a survey that was performed among experts from Serbian pharmaceutical-chemical industrial sector during 2010. An extensive questionnaire was used in the survey, grouping the questions in eight groups: Implementation of pharmaceutical quality system (AQ, Quality/strategy planning (QP, Human resource management (HR, Supply management (SM, Customer focus (CF, Process management (PM, Continuous improvement (CI, and Business results (BR. The primary goal of the research was to analyze the effects of the elements of first seven groups (AQ, QP, HR, SM, CF, PM, and CI that present various aspects of the implementation of PQS, on the elements of business results (BR. Based on empirical data, regression relations were formed to present the effects of all considered elements of PQS implementation on the business performance parameters (BR. The positive effects of PQS implementation on the business performances such as the assessment of performance indicators, continual products and/or services quality improvement, and efficient problem solving, are confirmed in the presented research for the Serbian pharmaceutical-chemical industrial sector. The results of the presented research will create a room for the improvement of the existing models in application, and for attracting interested parties that aim to commence this business standardization process. Hence, implementation of PQS is not only the regulatory

  5. Presentation of a Novel Model for Evaluation of Commercialization of Research and Development: Case Study of the Pharmaceutical Biotechnology Industry.

    Science.gov (United States)

    Emami, Hassan; Radfar, Reza

    2017-01-01

    The current situation in Iran suggests an appropriate basis for developing biotechnology industries, because the patents for the majority of hi-tech medicines registered in developed countries are ending. Biosimilar and technology-oriented companies which do not have patents will have the opportunity to enter the biosimilar market and move toward innovative initiatives. The present research proposed a model by which one can evaluate commercialization of achievements obtained from research with a focus on the pharmaceutical biotechnology industry. This is a descriptive-analytic study where mixed methodology is followed by a heuristic approach. The statistical population was pharmaceutical biotechnology experts at universities and research centers in Iran. Structural equations were employed in this research. The results indicate that there are three effective layers within commercialization in the proposed model. These are a general layer (factors associated with management, human capital, legal infrastructure, communication infrastructure, a technical and executive infrastructures, and financial factors), industrial layer (internal industrial factors and pharmaceutical industry factors), and a third layer that included national and international aspects. These layers comprise 6 domains, 21 indices, 41 dimensions, and 126 components. Compilation of these layers (general layer, industrial layer, and national and international aspects) can serve commercialization of research and development as an effective evaluation package.

  6. An Estimation of the Potential Utilization in Iranian Pharmaceutical Industry Involved in the Stock Exchange, 2008-2012

    Science.gov (United States)

    Annabi, Majid; Kebriaeezadeh, Abbas; Mohammadi, Timor; Marashi Shoshtari, Seyed Nasrolah; Abedin Dorkoosh, Farid; Pourreza, Abolghasem; Heydari, Hassan

    2017-01-01

    The aim of this study was to measure the potential of production and the capacity used in the pharmaceutical industry. Capacity use is the actual production rate to the potential output, which reflects the gap between actual production and production capacity. Through econometric methods, translog cost function in the short run along with functions of share cost of production factors is estimated through seemingly unrelated repeated regression (SURE) as a multivariate regression analysis provided by zeller. During the study the capacity used is decreasing. The capacity used, which calculated by weighted average, also decreased and the amount during the study period is much less than the simple average of the industry. Average capacity utilization in the industry over five years of study is equal to 57% while the average capacity used calculated by the weighted of industry average is 37%. To enhance the economic potential requires a proper use of resources, creation of favorable economic structure and productivity of the industry. Due to the large amount of unused capacity in the pharmaceutical industry there is no need to invest anymore unless in new grounds and it is obvious that more investment will change using capacity. PMID:29552074

  7. An Estimation of the Potential Utilization in Iranian Pharmaceutical Industry Involved in the Stock Exchange, 2008-2012.

    Science.gov (United States)

    Annabi, Majid; Kebriaeezadeh, Abbas; Mohammadi, Timor; Marashi Shoshtari, Seyed Nasrolah; Abedin Dorkoosh, Farid; Pourreza, Abolghasem; Heydari, Hassan

    2017-01-01

    The aim of this study was to measure the potential of production and the capacity used in the pharmaceutical industry. Capacity use is the actual production rate to the potential output, which reflects the gap between actual production and production capacity . Through econometric methods, translog cost function in the short run along with functions of share cost of production factors is estimated through seemingly unrelated repeated regression (SURE) as a multivariate regression analysis provided by zeller. During the study the capacity used is decreasing. The capacity used, which calculated by weighted average, also decreased and the amount during the study period is much less than the simple average of the industry. Average capacity utilization in the industry over five years of study is equal to 57% while the average capacity used calculated by the weighted of industry average is 37%. To enhance the economic potential requires a proper use of resources, creation of favorable economic structure and productivity of the industry. Due to the large amount of unused capacity in the pharmaceutical industry there is no need to invest anymore unless in new grounds and it is obvious that more investment will change using capacity.

  8. [Attitudes of general practitioners to pharmaceutical sales representatives in Sousse].

    Science.gov (United States)

    Ben Abdelaziz, A; Harrabi, I; Rahmani, S; Ghedira, A; Gaha, K; Ghannem, H

    2003-01-01

    The therapeutic knowledge of physicians is the corner stone to the rational use of medicines; however information about medicines is generally obtained from the pharmaceutical industry via their sales representatives (reps). We aimed to identify general practitioners' (GPs) attitudes to pharmaceutical reps and the information they provide. We surveyed 140 GPs using a self-administered questionnaire. The response rate was 78% (72 GPs from the public sector and 68 from the private sector). About 10% of the GPs said they received daily visits from pharmaceutical reps; 84% of GPs considered them an efficient source of information and 31% said they might change their therapeutic prescribing following visits from these reps. Because of their positive perception of pharmaceutical reps, GPs are susceptible to the information they provide. Controlling the validity of the therapeutic information imparted by the pharmaceutical industry is thus a fundamental component of the programme for the rational use of medicines.

  9. Energy Efficiency Improvement and Cost Saving Opportunities for the Pharmaceutical Industry. An ENERGY STAR Guide for Energy and Plant Managers

    Energy Technology Data Exchange (ETDEWEB)

    Galitsky, Christina; Galitsky, Christina; Chang, Sheng-chieh; Worrell, Ernst; Masanet, Eric

    2008-03-01

    The U.S. pharmaceutical industry consumes almost $1 billion in energy annually. Energy efficiency improvement is an important way to reduce these costs and to increase predictable earnings, especially in times of high energy price volatility. There are a variety of opportunities available at individual plants in the U.S. pharmaceutical industry to reduce energy consumption in a cost-effective manner. This Energy Guide discusses energy efficiency practices and energy efficient technologies that can be implemented at the component, process, system, and organizational levels. A discussion of the trends, structure, and energy consumption characteristics of the U.S. pharmaceutical industry is provided along with a description of the major process steps in the pharmaceutical manufacturing process. Expected savings in energy and energy-related costs are given for many energy efficiency measures, based on case study data from real-world applications in pharmaceutical and related facilities worldwide. Typical measure payback periods and references to further information in the technical literature are also provided, when available. The information in this Energy Guide is intended to help energy and plant managers reduce energy consumption in a cost-effective manner while meeting regulatory requirements and maintaining the quality of products manufactured. At individual plants, further research on the economics of the measures?as well as their applicability to different production practices?is needed to assess potential implementation of selected technologies.

  10. Publication Trend of Clinical Trials with Negative Results Funded by Pharmaceutical Industries for the 2007-2012 Period

    Directory of Open Access Journals (Sweden)

    Evert A. Jiménez-Cotes

    2015-01-01

    Full Text Available Abstract: Objective: To evaluate the results of clinical trials financed by the pharmaceutical industries during the period 2007-2012 in a general medical journal. Materials and methods: We performed an observational cross sectional study where originals clinical trials financed by the pharmaceutical industry published between 2007 and 2012 in the journal The New England Journal of Medicine (http://www.nejm.org were reviewed. Trend Chi2 test was used to evaluate the results of studies over the years. A database was created with different variables, identifying the number of publications and the period of greater publishing negatives studies, as well as the medical specialty and pharmaceutical industry funding. Results: 321 clinical trials were analyzed. The Odds Ratio was calculated for each year evaluated, finding a Chi2 of linear trend in negatives studies of 2.91 with value p 0.08 and positive studies of 1.16 with value p 0.28. It was found that in the period 2007-2009 123 studies were published, 40 % of which presented negative results; unlike the 2010-2012 period in which 198 clinical trials where published, 142 of them, showed positive results, OR 1.68, 95 % CI (1.02-2.78 value p 0.03. The highest figures of negative results were published in 2007: 44.7 %. Conclusions: A progressive decrease in the number of publications with annual general negative results has been observed. A statistically significant difference in the publication of negative studies per year was not found between the periods 2007-2012. The medical specialty that showed the largest number of total and negative publications in both periods was cardiology. The pharmaceutical industry that sponsored most total clinical trials with negative results in both periods did so through Merck, Glaxo SmithKline, and Sanofi-Aventis. 50% of neurology publications showed negative results.

  11. The role of the pharmaceutical animal health industry in post-marketing surveillance of resistance.

    Science.gov (United States)

    Lens, S

    1993-06-01

    The pharmaceutical animal health industry must be committed to the total life cycle of products, i.e. during both the pre- and post-marketing period. Support of antibacterial agents during the postmarketing period is not restricted to maintaining a well-established distribution and promotion system. Care has to be taken continuously to maintain and/or improve the quality, safety (for user, target animal and environment) and clinical efficacy. The pharmaceutical industry contributes to this by: 1. Introducing antibacterials in different animal species for the most effective disease condition only and by ensuring the veterinary profession is informed about relevant findings on: a. the mechanism of action; b. pharmacodynamic properties; c. pharmacokinetic properties (plasma, target tissue); d. clinical efficacy data and in vitro sensitivity data; e. valid species-specific MIC breakpoints; f. precise dose and treatment regime. 2. Updating on a regular basis on: a. new findings on the mechanism of action (in vitro and in vivo); b. the optimal use program in the light of changes in animal husbandry, farm management and epidemiology on national and international level; c. adjustment of species-specific MIC breakpoints when necessary. 3. Providing continuous information in collaboration with animal health laboratories about: a. clinical field surveillance for efficacy (national, international); b. in vitro sensitivity/resistance surveillance (national, international); c. use of in vitro data to support prediction of in vivo efficacy. Surveillance of resistance, in vitro, is therefore part of a package of information needed on a routine basis by the pharmaceutical industry to allow the best possible use of antibacterials and to minimize induction of resistance.(ABSTRACT TRUNCATED AT 250 WORDS)

  12. Activity of coenzyme Q 10 (Q-Ter multicomposite) on recovery time in noise-induced hearing loss.

    Science.gov (United States)

    Staffa, Paola; Cambi, Jacopo; Mezzedimi, Chiara; Passali, Desiderio; Bellussi, Luisa

    2014-01-01

    A potential consequence of exposure to noise is a temporary reduction in auditory sensitivity known as temporary threshold shift (TTS), which mainly depends on the intensity and duration of exposure to the noise. Recovery time is related to the amount of initial hearing loss, and the most recovery takes place during the first 15 min following exposure. This study evaluated the efficacy in otoprotection against noise-induced hearing loss of an orally administrated food supplement containing coenzyme Q 10 -Ter. This water-soluble formulation of coenzyme Q 10 shows better bioavailability than the native form and has been found to have a protective effect on outer hair cells after exposure to noise in animal models. Thirty volunteers were enrolled, and the right ear of each subject was exposed to a narrow-band noise centered at 3 kHz for 10 min at the intensity of 90 dB HL. In the 30 subjects enrolled, TTS was evaluated after 2, 15, and 30 min and the recovery time was recorded in each subject. The longest recovery time was 45 min. Among the 18 subjects who underwent a second test after treatment with Q-Ter, the mean recovery time was 31.43 min. The results of the present study show that 30 days' treatment with Q-Ter can aid faster recovery after exposure to noise (P < 0.0001). The reduction in the recovery time following treatment can be explained by Q-Ter-mediated improvement of the outer hair cells' response to oxidative stress.

  13. The importance of social networks on the origins of argentinian pharmaceutical industry. The case of Catalans

    OpenAIRE

    Campins, Mónica; Pfeiffer, Ana

    2017-01-01

    This article aims to give a broader interpretation of the development of science-based industries in latecomer countries like Argentina. The approach used in the research work is supported by contributions from Nuria Puig on the role of social networks in the pharmaceutical industry development in late industrializing countries and reinforces the idea of Franco Ramella about the importance of a strong use of network concept. Historical research shows that social networks of the Catalan commun...

  14. Modeling of process parameters for enhanced production of coenzyme Q10 from Rhodotorula glutinis.

    Science.gov (United States)

    Balakumaran, Palanisamy Athiyaman; Meenakshisundaram, Sankaranarayanan

    2015-01-01

    Coenzyme Q10 (CoQ10) plays an indispensable role in ATP generation through oxidative phosphorylation and helps in scavenging superoxides generated during electron transfer reactions. It finds extensive applications specifically related to oxidative damage and metabolic dysfunctions. This article reports the use of a statistical approach to optimize the concentration of key variables for the enhanced production of CoQ10 by Rhodotorula glutinis in a lab-scale fermenter. The culture conditions that promote optimum growth and CoQ10 production were optimized and the interaction of significant variables para-hydroxybenzoic acid (PHB, 819.34 mg/L) and soybean oil (7.78% [v/v]) was studied using response surface methodology (RSM). CoQ10 production increased considerably from 10 mg/L (in control) to 39.2 mg/L in batch mode with RSM-optimized precursor concentration. In the fed-batch mode, PHB and soybean oil feeding strategy enhanced CoQ10 production to 78.2 mg/L.

  15. Coenzyme Q10 Status as a Determinant of Muscular Strength in Two Independent Cohorts.

    Directory of Open Access Journals (Sweden)

    Alexandra Fischer

    Full Text Available Aging is associated with sarcopenia, which is a loss of skeletal muscle mass and function. Coenzyme Q10 (CoQ10 is involved in several important functions that are related to bioenergetics and protection against oxidative damage; however, the role of CoQ10 as a determinant of muscular strength is not well documented. The aim of the present study was to evaluate the determinants of muscular strength by examining hand grip force in relation to CoQ10 status, gender, age and body mass index (BMI in two independent cohorts (n = 334, n = 967. Furthermore, peak flow as a function of respiratory muscle force was assessed. Spearman's correlation revealed a significant positive association between CoQ10/cholesterol level and hand grip in the basic study population (p<0.01 as well as in the validation population (p<0.001. In the latter, we also found a negative correlation with the CoQ10 redox state (p<0.01, which represents a lower percentage of the reduced form of CoQ10 (ubiquinol in subjects who exhibit a lower muscular strength. Furthermore, the age of the subjects showed a negative correlation with hand grip (p<0.001, whereas BMI was positively correlated with hand grip (p<0.01, although only in the normal weight subgroup (BMI <25 kg/m2. Analysis of the covariance (ANCOVA with hand grip as the dependent variable revealed CoQ10/cholesterol as a determinant of muscular strength and gender as the strongest effector of hand grip. In conclusion, our data suggest that both a low CoQ10/cholesterol level and a low percentage of the reduced form of CoQ10 could be an indicator of an increased risk of sarcopenia in humans due to their negative associations to upper body muscle strength, peak flow and muscle mass.

  16. Potential role of coenzyme Q10 in facilitating recovery from statin-induced rhabdomyolysis.

    Science.gov (United States)

    Wang, L W; Jabbour, A; Hayward, C S; Furlong, T J; Girgis, L; Macdonald, P S; Keogh, A M

    2015-04-01

    Rhabdomyolysis is a rare, but serious complication of statin therapy, and represents the most severe end of the spectrum of statin-induced myotoxicity. We report a case where coenzyme Q10 facilitated recovery from statin-induced rhabdomyolysis and acute renal failure, which had initially persisted despite statin cessation and haemodialysis. This observation is biologically plausible due to the recognised importance of coenzyme Q10 in mitochondrial bioenergetics within myocytes, and the fact that statins inhibit farnesyl pyrophosphate production, a biochemical step crucial for coenzyme Q10 synthesis. Coenzyme Q10 is generally well tolerated, and may potentially benefit patients with statin-induced rhabdomyolysis. © 2015 Royal Australasian College of Physicians.

  17. A chromosome 10 variant with a 12 Mb inversion [inv(10)(q11.22q21.1)] identical by descent and frequent in the Swedish population.

    Science.gov (United States)

    Entesarian, Miriam; Carlsson, Birgit; Mansouri, Mahmoud Reza; Stattin, Eva-Lena; Holmberg, Eva; Golovleva, Irina; Stefansson, Hreinn; Klar, Joakim; Dahl, Niklas

    2009-03-01

    We identified a paracentric inversion of chromosome 10 [inv(10)(q11.22q21.1)] in 0.20% of Swedish individuals (15/7,439) referred for cytogenetic analysis. A retrospective analysis of 8,896 karyotypes from amniocenteses in Sweden revealed a carrier frequency of 0.079% (7/8,896) for the inversion. Cloning and detailed analysis of the inversion breakpoint regions show enrichment for interspersed repeat elements and AT-stretches. The centromeric breakpoint coincides with that of a predicted inversion from HapMap data, which suggests that this region is involved in several chromosome 10 variants. No known gene or predicted transcript are disrupted by the inversion which spans approximately 12 Mb. Carriers from four non-related Swedish families have identical inversion breakpoints and haplotype analysis confirmed that the rearrangement is identical by descent. Diagnosis was retrieved in 6 out of the 15 carriers referred for cytogenetic analysis. No consistent phenotype was found to be associated with the inversion. Our study demonstrates that the inv(10)(q11.22q21.1) is a rare and inherited chromosome variant with a broad geographical distribution in Sweden. 2009 Wiley-Liss, Inc.

  18. The Identification Of Realistic Export Opportunities For The South African Pharmaceutical Industry

    OpenAIRE

    Wilma Viviers; Martie Lubbe; Ermie Steenkamp; Douglas Olivier

    2014-01-01

    South Africa needs to advance its industrialisation process and diversify its exports if it is to enhance its global competitiveness ranking and meaningfully tackle the double scourge of unemployment and poverty. The pharmaceutical industry makes a significant contribution to the countrys economy, and has a growing international footprint. However, export activity is largely centred on Southern and Eastern Africa, while markets in other parts of the world remain largely untapped. A lo...

  19. R&D INTENSITY AND IPO UNDERPRICING: CASE STUDY ON PHARMACEUTICAL AND BIOTECH INDUSTRIES IN THE US

    Directory of Open Access Journals (Sweden)

    Tommy C. Efrata

    2016-02-01

    Full Text Available Asymmetric information between the issuer to potential investors believed by some academics in finance as one of the main causes of the phenomenon of underpricing at the time of the initial public offering (IPO. On science and technology-based company main problem lies in how to conduct assessments on the future value of a product that is still in the development stage. The issue became more prominent on pharmaceutical companies and biotechnology, due to the characteristics of this industry is the high expense, complex process, and the lengthy process of research and development (R & D of a product. This study describes the characteristics above is associated with the phenomenon of underpricing when companies conduct IPO. The samples are 82 pharmaceutical companies and biotechnology conduct IPO in the United States stock market in 1998-2005. The results of this study revealed a negative correlation between the intensity of R & D and IPO underpricing phenomenon in this industry. These studies have identified R & D as the main source of information asymmetry that led to the phenomenon of underpricing for pharmaceutical companies and biotechnology.

  20. Strategic of Applying Free Chemical Usage In Purified Water System For Pharmaceutical Industry Toward CPOB (Cara Pembuatan Obat yang Baik Indonesia To Reducing Environmental Pollution

    Directory of Open Access Journals (Sweden)

    Kartono R.

    2014-03-01

    Full Text Available The purpose of this paper is to examine the sets of model and literature review to prove that strategy of applying free chemical usage in purified water system for pharmaceutical industry would be help the existing and new pharmaceutical companies to comply with part of Natioanal Agency of Drug and Food Control / Badan Pengawas Obat dan Makanan (NADFC/BPOM regulation in order to achieve “Cara Pembuatan Obat yang Baik” (CPOB of Indonesia pharmaceutical industry. One of the main reasons is when we figured out the number of Indonesian pharmaceutical industries in 2012 are kept reducing compare to the increasing numbers of Indonesian population growth. This strategy concept also might help the industries to reducing environmental pollution, and operational cost in pharmaceutical industries, by reducing of the chemical usage for water treatment process in floculation and cougulation and chlorination for sterillization. This new model is free usage of chemicals for purified water generation system process and sterilization. The concept offering of using membrane technology- Reverse Osmosis (RO membrane base treatment to replace traditional chemical base treatment, following enhance Electrodeionization (EDI as final polisher for controlling conductivity, and finally Ultra Violet (UV disinfectant technology as final guard for bacteria controls instead of chemical base system in purified water generation system.

  1. Strategic of Applying Free Chemical Usage In Purified Water System For Pharmaceutical Industry Toward CPOB (Cara Pembuatan Obat yang Baik) Indonesia To Reducing Environmental Pollution

    Science.gov (United States)

    Kartono, R.; Basuki, Y. T.

    2014-03-01

    The purpose of this paper is to examine the sets of model and literature review to prove that strategy of applying free chemical usage in purified water system for pharmaceutical industry would be help the existing and new pharmaceutical companies to comply with part of Natioanal Agency of Drug and Food Control / Badan Pengawas Obat dan Makanan (NADFC/BPOM) regulation in order to achieve "Cara Pembuatan Obat yang Baik" (CPOB) of Indonesia pharmaceutical industry. One of the main reasons is when we figured out the number of Indonesian pharmaceutical industries in 2012 are kept reducing compare to the increasing numbers of Indonesian population growth. This strategy concept also might help the industries to reducing environmental pollution, and operational cost in pharmaceutical industries, by reducing of the chemical usage for water treatment process in floculation and cougulation and chlorination for sterillization. This new model is free usage of chemicals for purified water generation system process and sterilization. The concept offering of using membrane technology- Reverse Osmosis (RO) membrane base treatment to replace traditional chemical base treatment, following enhance Electrodeionization (EDI) as final polisher for controlling conductivity, and finally Ultra Violet (UV) disinfectant technology as final guard for bacteria controls instead of chemical base system in purified water generation system.

  2. A Method to Identify Best Available Technologies (BAT) for Hydrogenation Reactors in the Pharmaceutical Industry

    Czech Academy of Sciences Publication Activity Database

    Le Doan, T.V.; Stavárek, Petr; de Bellefon, C.

    2012-01-01

    Roč. 2, č. 3 (2012), s. 77-82 ISSN 2062-249X Grant - others:IMPULSE(XE) FP6-NMP2-CT-2005-011816 Institutional support: RVO:67985858 Keywords : hydrogenation * pharmaceuticals * methodology Subject RIV: CI - Industrial Chemistry, Chemical Engineering Impact factor: 4.091, year: 2012

  3. Plasma coenzyme Q10 concentrations are not decreased in male patients with coronary atherosclerosis

    NARCIS (Netherlands)

    Vijver, L.P.L. van de; Weber, C.; Kardinaal, A.F.M.; Grobbee, D.E.; Princen, H.M.G.; Poppel, G. van

    1999-01-01

    Coenzyme Q10 (CoQ10) is an important mitochondrial electron transfer component and has been postulated to function as a powerful antioxidant protecting LDL from oxidative damage. It could thus reduce the risk of cardiovascular disease. Thus far, beneficial effects of supplementation with CoQ10 have

  4. Coenzyme Q10 and its effects in the treatment of neurodegenerative diseases

    Directory of Open Access Journals (Sweden)

    Graciela Cristina dos Santos

    2009-12-01

    Full Text Available According to clinical and pre-clinical studies, oxidative stress and its consequences may be the cause or, at least, a contributing factor, to a large number of neurodegenerative diseases. These diseases include common and debilitating disorders, characterized by progressive and irreversible loss of neurons in specific regions of the brain. The most common neurodegenerative diseases are Parkinson's disease, Huntington's disease, Alzheimer's disease and amyotrophic lateral sclerosis. Coenzyme Q10 (CoQ10 has been extensively studied since its discovery in 1957. It is a component of the electron transportation chain and participates in aerobic cellular respiration, generating energy in the form of adenosine triphosphate (ATP. The property of CoQ10 to act as an antioxidant or a pro-oxidant, suggests that it also plays an important role in the modulation of redox cellular status under physiological and pathological conditions, also performing a role in the ageing process. In several animal models of neurodegenerative diseases, CoQ10 has shown beneficial effects in reducing disease progression. However, further studies are needed to assess the outcome and effectiveness of CoQ10 before exposing patients to unnecessary health risks at significant costs.De acordo com estudos clínicos e pré-clínicos, o estresse oxidativo e suas conseqüências podem ser a causa, ou, no mínimo, o fator que contribui para grande número de doenças degenerativas. Estas doenças incluem problemas comuns e debilitantes, caracterizados por perda progressiva e irreversível de neurônios em regiões específicas do cérebro. As doenças degenerativas mais comuns são doença de Parkinson, de Hutington, de Alzheimer e esclerose amiotrófica lateral. A Coenzima Q10 (CoQ10 tem sido intensamente estudada desde sua descoberta, em 1957. É um componente da cadeia de transporte eletrônico e participa da respiração aeróbica celular, gerando energia na forma de trifosfato de

  5. Does growing up with a physician influence the ethics of medical students' relationships with the pharmaceutical industry? The cases of the US and Poland.

    Science.gov (United States)

    Makowska, Marta

    2017-08-10

    Medical schools have a major impact on future doctors' ethics and their attitudes towards cooperation with the pharmaceutical industry. From childhood, medical students who are related to a physician are exposed to the characteristics of a medical career and learn its professional ethics not only in school but also in the family setting. The present paper sought to answer the research question: 'How does growing up with a physician influence medical students' perceptions of conflicts of interest in their relationships with industry?' An anonymous questionnaire was completed by 451 medical students from four Philadelphia medical schools and 554 medical students from Warsaw Medical University during 2013. Medical schools in these two cities were chosen because they are both university cities with similar population sizes. Students who had and who did not have a family member working as a physician were compared using chi-square analysis. Data were analysed for each country separately. For both the US and Poland, there were statistically significant differences (p < .05) between medical students with a physician as a family member and other students with respect to views regarding relationship with the pharmaceutical industry. In both groups, this difference occurred for three important dimensions: students' relationship with the pharmaceutical industry; students' views on physicians' rights to cooperate with the pharmaceutical industry; trust in the pharmaceutical industry. In the US, students related to a doctor were characterized by more restrictive opinions on all three dimensions than other students (e.g., 27.8% of the former students vs. 31.4% of the latter students thought doctors had unrestricted rights to cooperate with the industry). However, the contrary was observed in Poland: students with a physician in the family had less strict views than their colleagues (e.g., 56.8% of the former vs. 39.7% of the latter thought that doctors should have unrestricted

  6. Pfizer and the Challenges of the Global Pharmaceutical Industry 2013 (A)

    DEFF Research Database (Denmark)

    Nell, Phillip Christopher

    2013-01-01

    This is part of a case series. The case focuses on describing and analysing the environment, profitability and competitiveness of the global pharmaceutical industry, and to evaluate the current and future strategy of Pfizer. It features a large number of tables with quantitative data that help...... solving the case study. The case starts with a short description of recent important events that might mark a turning point for the whole industry. It then focuses on the overall market on drugs - structure, growth, blockbusters, and the influence of national health care systems. Furthermore, firms’ R...... a number of strategic manoeuvres of major players in the last years. At the end, the reader is referred back to the Pfizer situation and Pfizer’s recent strategic initiatives and responses to the market changes....

  7. Tropical Journal of Pharmaceutical Research

    African Journals Online (AJOL)

    Journal Homepage Image. We seek to encourage pharmaceutical and allied research of tropical and international relevance and to foster multidisciplinary research and collaboration among scientists, the pharmaceutical industry and the healthcare professionals. We publish articles in pharmaceutical sciences and related ...

  8. A Boy with an LCR3/4-Flanked 10q22.3q23.2 Microdeletion and Uncommon Phenotypic Features

    Science.gov (United States)

    Petrova, E.; Neuner, C.; Haaf, T.; Schmid, M.; Wirbelauer, J.; Jurkutat, A.; Wermke, K.; Nanda, I.; Kunstmann, E.

    2014-01-01

    The recurrent 10q22.3q23.2 deletion with breakpoints within low copy repeats 3 and 4 is a rare genomic disorder, reported in only 13 patients to date. The phenotype is rather uncharacteristic, which makes a clinical diagnosis difficult. A phenotypic feature described in almost all patients is a delay in speech development, albeit systematic studies are still pending. In this study, we report on a boy with an LCR3/4-flanked 10q22.3q23.2 deletion exhibiting an age-appropriate language development evaluated by a standardized test at an age of 2 years and 3 months. The boy was born with a cleft palate – a feature not present in any of the patients described before. Previously reported cases are reviewed, and the role of the BMPR1A gene is discussed. The phenotype of patients with an LCR3/4-flanked 10q22.3q23.2 deletion can be rather variable, so counseling the families regarding the prognosis of an affected child should be done with caution. Long-term studies of affected children are needed to delineate the natural history of this rare disorder. PMID:24550761

  9. The Rhetorical Helix of the Biotechnology and Pharmaceutical Industries: Strategies of Transformation through Definition, Description and Ingratiation

    Science.gov (United States)

    Gretton, Linda Burak

    2009-01-01

    The current pharmaceutical industry, whose origins date from the early 20th century, and the biotechnology industry, which emerged in the 1980s both have foundations built on the modern scientific method and share a mission to develop new drugs for humans and animals. At the same time, they are also made distinct by size (small biotechs versus…

  10. The exploitation of "sicko-chatting" by the pharmaceutical industry : a strategy for the normalization of drug use

    OpenAIRE

    Niquette , Manon

    2012-01-01

    International audience; The Exploitation of 'sicko-chatting' by the Pharmaceutical industry: a strategy for the Normalization of drug use Pharmaceutical drugs are consumer goods. As such, they inscribe the transition from normality to pathology within the ambit of health marketing (Duclos, 2008, p. 109). It is now widely acknowledged that this pathology is not just a mere quantitative modification of the normal state, but that it also implies the patient's qualitative assessment of his or her...

  11. Statistical applications for chemistry, manufacturing and controls (CMC) in the pharmaceutical industry

    CERN Document Server

    Burdick, Richard K; Pfahler, Lori B; Quiroz, Jorge; Sidor, Leslie; Vukovinsky, Kimberly; Zhang, Lanju

    2017-01-01

    This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recomm...

  12. Water-soluble Coenzyme Q10 formulation (Q-ter) promotes outer hair cell survival in a guinea pig model of noise induced hearing loss (NIHL).

    Science.gov (United States)

    Fetoni, Anna Rita; Piacentini, Roberto; Fiorita, Antonella; Paludetti, Gaetano; Troiani, Diana

    2009-02-27

    The mitochondrial respiratory chain is a powerful source of reactive oxygen species (ROS) also in noise induced hearing loss (NIHL) and anti-oxidants and free-radicals scavengers have been shown to attenuate the damage. Coenzyme Q(10) (CoQ(10)) or ubiquinone has a bioenergetic role as a component of the mithocondrial respiratory chain, it inhibits mitochondrial lipid peroxidation, inducing ATP production and it is involved in ROS removal and prevention of oxidative stress-induced apoptosis. However the therapeutic application of CoQ(10) is limited by the lack of solubility and poor bio- availability, therefore it is a challenge to improve its water solubility in order to ameliorate the efficacy in tissues and fluids. This study was conducted in a model of acoustic trauma in the guinea pig where the effectiveness of CoQ(10) was compared with a soluble formulation of CoQ(10) (multicomposite CoQ(10) Terclatrate, Q-ter) given intraperitoneally 1 h before and once daily for 3 days after pure tone noise exposure (6 kHz for 1 h at 120 dB SPL). Functional and morphological studies were carried out by measuring auditory brainstem responses, scanning electron microscopy for hair cell loss count, active caspase 3 staining and terminal deoxynucleotidyl transferase-mediated dUTP labelling assay in order to identify initial signs of apoptosis. Treatments decreased active caspase 3 expression and the number of apoptotic cells, but animals injected with Q-ter showed a greater degree of activity in preventing apoptosis and thus in improving hearing. These data confirm that solubility of Coenzyme Q(10) improves the ability of CoQ(10) in preventing oxidative injuries that result from mitochondrial dysfunction.

  13. Acute Hypoglycemia Induces Painful Neuropathy and the Treatment of Coenzyme Q10

    Directory of Open Access Journals (Sweden)

    Yan Ping Zhang

    2016-01-01

    Full Text Available Diabetic neuropathic pain is reduced with tight glycemic control. However, strict control increases the risk of hypoglycemic episodes, which are themselves linked to painful neuropathy. This study explored the effects of hypoglycemia-related painful neuropathy. Pretreatment with coenzyme Q10 (CoQ10 was performed to explore the preventive effect of CoQ10 on hypoglycemia-related acute neuropathic pain. Two strains of mice were used and 1 unit/kg of insulin was given to induce hypoglycemia. Mechanical sensitivity of hindpaw withdrawal thresholds was measured using von Frey filaments. Blood glucose levels were clamped at normal levels by joint insulin and glucose injection to test whether insulin itself induced hypersensitivity. Results suggest that the increased mechanical sensitivity after insulin injection is related to decreased blood glucose levels. When blood glucose levels remained at a normal level by the linked administration of insulin and glucose, mice demonstrated no significant change in mechanical sensitivity. Pretreatment with CoQ10 prevented neuropathic pain and the expression of the stress factor c-Fos. These results support the concept that pain in the diabetic scenario can be the result of hypoglycemia and not insulin itself. Additionally, pretreatment with CoQ10 may be a potent preventive method for the development of neuropathic pain.

  14. Utilization of Lavandula angustifolia Miller extracts as naturalrepellents, pharmaceutical and industrial auxiliaries

    Directory of Open Access Journals (Sweden)

    AYOE YUSUFOGLU

    2004-01-01

    Full Text Available Essential oils, absolutes and concretes were prepared from the flowers and leaves of the plant Lavandula angustifolia Miller cultivated in the Bosphorus region of Istanbul, Turkey. The difference in the chemical composition of the mentioned extracts was investigated and compared by using a combination of capillary GC-MS with the aim of offering them as repellent, pharmaceutical and industrial auxiliaries. The IR-spectra, the yields and the physico-chemical data of the extracts were also analysed.

  15. Non clinical research at CENTIS supporting biotechnological and pharmaceutical industry

    International Nuclear Information System (INIS)

    Hernandez Gonzalez, Ignacio

    2012-01-01

    Drugs production is a highly demanding industry because the rigor of legislations and guidelines. Standards are applied to manufacturing facilities and also to research and development stage. Our national biotechnological industry is developing and producing important medications for diseases like cancer, some of them in the national and international market. Isotopes Centre is an institution supporting such development by means of a work platform to carry out researches in the field of pharmacokinetic and biodistribution in experimental models. Accumulated experience allows us to contribute to research and development of different kind of molecules as pharmaceuticals, specially the biotechnological ones. We are evolving in direction to new technologies and methodologies more suitable to current standards. Radiolabeling is still a convenient choice considering present and new imaging technologies to investigate distribution and kinetic in living subjects. With the techniques we have and the ones to incorporate in a near future, new and more demanding investigations will be affordable. (author)

  16. Does a General Temperature-Dependent Q10 Model of Soil Respiration Exist at Biome and Global Scale?

    Institute of Scientific and Technical Information of China (English)

    Hua CHEN; Han-Qin TIAN

    2005-01-01

    Soil respiration (SR) is commonly modeled by a Q10 (an indicator of temperature sensitivity)function in ecosystem models. Q10is usually treated as a constant of 2 in these models, although Q10 value of SR often decreases with increasing temperatures. It remains unclear whether a general temperaturedependent Q10 model of SR exists at biome and global scale. In this paper, we have compiled the long-term Q10 data of 38 SR studies ranging from the Boreal, Temperate, to Tropical/Subtropical biome on four continents.Our analysis indicated that the general temperature-dependent biome Q10 models of SR existed, especially in the Boreal and Temperate biomes. A single-exponential model was better than a simple linear model in fitting the average Q10 values at the biome scale. Average soil temperature is a better predictor of Q10 value than average air temperature in these models, especially in the Boreal biome. Soil temperature alone could explain about 50% of the Q10 variations in both the Boreal and Temperate biome single-exponential Q10 model. Q10 value of SR decreased with increasing soil temperature but at quite different rates among the three biome Q10 models. The k values (Q10 decay rate constants) were 0.09, 0.07, and 0.02/℃ in the Boreal, Temperate, and Tropical/Subtropical biome, respectively, suggesting that Q10 value is the most sensitive to soil temperature change in the Boreal biome, the second in the Temperate biome, and the least sensitive in the Tropical/Subtropical biome. This also indirectly confirms that acclimation of SR in many soil warming experiments probably occurs. The k value in the "global" single-exponential Q10 model which combined both the Boreal and Temperate biome data set was 0.08/℃. However, the global general temperature-dependent Q10model developed using the data sets of the three biomes is not adequate for predicting Q10 values of SR globally.The existence of the general temperature-dependent Q10 models of SR in the Boreal and

  17. How to revive breakthrough innovation in the pharmaceutical industry.

    Science.gov (United States)

    Munos, Bernard H; Chin, William W

    2011-06-29

    Over the past 20 years, pharmaceutical companies have implemented conservative management practices to improve the predictability of therapeutics discovery and success rates of drug candidates. This approach has often yielded compounds that are only marginally better than existing therapies, yet require larger, longer, and more complex trials. To fund them, companies have shifted resources away from drug discovery to late clinical development; this has hurt innovation and amplified the crisis brought by the expiration of patents on many best-selling drugs. Here, we argue that more breakthrough therapeutics will reach patients only if the industry ceases to pursue "safe" incremental innovation, re-engages in high-risk discovery research, and adopts collaborative innovation models that allow sharing of knowledge and costs among collaborators.

  18. Supplementation of Coenzyme Q10 among Patients with Type 2 Diabetes Mellitus

    Directory of Open Access Journals (Sweden)

    Qiuhua Shen

    2015-05-01

    Full Text Available Type 2 diabetes mellitus (T2DM is a major cause of morbidity and mortality with ever increasing prevalence in the United States and worldwide. There is growing body of evidence suggesting that mitochondrial dysfunction secondary to oxidative stress plays a critical role in the pathogenesis of T2DM. Coenzyme Q10 is an important micronutrient acting on the electron transport chain of the mitochondria with two major functions: (1 synthesis of adenosine triphosphate (ATP; and (2 a potent antioxidant. Deficiency in coenzyme Q10 is often seen in patients with T2DM. Whether restoration of coenzyme Q10 will help alleviate oxidative stress, preserve mitochondrial function, and thus improve glycemic control in T2DM is unclear. This article reviews the relationships among oxidative stress, mitochondrial dysfunction, and T2DM and examines the evidence for potential use of coenzyme Q10 as a supplement for the treatment of T2DM.

  19. Water-soluble coenzyme Q10 formulation in presbycusis: long-term effects.

    Science.gov (United States)

    Guastini, Luca; Mora, Renzo; Dellepiane, Massimo; Santomauro, Valentina; Giorgio, Manini; Salami, Angelo

    2011-05-01

    These findings provide the basis for understanding the duration of the effect after the last use of the drug and encourage a larger clinical trial to collect additional evidence on the effect of coenzyme Q10 (CoQ10) in preventing the development of hearing loss in subjects with presbycusis. The aim of this study was to evaluate the long-term effects of a water-soluble formulation of CoQ10 (Q-TER) in subjects with presbycusis. Sixty patients with presbycusis were included and divided at random into three numerically equal groups. For 30 days, group A underwent therapy with Q-TER, group B underwent therapy with vitamin E, and group C received placebo. Before, at the end, and 6 months after the end of the treatment, all patients underwent evaluation of pure tone audiometry, transient evoked otoacoustic emissions and otoacoustic products of distortion, auditory brainstem response, and speech audiometry. Compared with group B, at the end of the treatment in group A the pure tone audiometry showed a significant (p < 0.05) improvement of the audiometric thresholds at 1000, 2000, 4000, and 8000 Hz. This improvement was confirmed by the speech audiometry and last check. We found no significant differences in the other parameters and in group C.

  20. Pharmaceutical virtue.

    Science.gov (United States)

    Martin, Emily

    2006-06-01

    In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good.

  1. From maturity to value-added innovation: lessons from the pharmaceutical and agro-biotechnology industries.

    Science.gov (United States)

    Mittra, James; Tait, Joyce; Wield, David

    2011-03-01

    The pharmaceutical and agro-biotechnology industries have been confronted by dwindling product pipelines and rapid developments in life sciences, thus demanding a strategic rethink of conventional research and development. Despite offering both industries a solution to the pipeline problem, the life sciences have also brought complex regulatory challenges for firms. In this paper, we comment on the response of these industries to the life science trajectory, in the context of maturing conventional small-molecule product pipelines and routes to market. The challenges of managing transition from maturity to new high-value-added innovation models are addressed. Furthermore, we argue that regulation plays a crucial role in shaping the innovation systems of both industries, and as such, we suggest potentially useful changes to the current regulatory system. Copyright © 2010 Elsevier Ltd. All rights reserved.

  2. “Does Organizational Culture Influence the Ethical Behavior in the Pharmaceutical Industry?”

    OpenAIRE

    Nagashekhara, Molugulu; Agil, Syed Omar Syed

    2012-01-01

    Study of ethical behavior among medical representatives in the profession is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the influence of organizational culture on ethical behavior of medical representatives. Medical representatives working for both domestic and multinational companies constitutes the sample (n=300). Data is collected using a simple random and cluster sampling through a structured question...

  3. Entrepreneurial patent management in pharmaceutical startups.

    Science.gov (United States)

    Holgersson, Marcus; Phan, Tai; Hedner, Thomas

    2016-07-01

    Startups fill an increasingly important role as innovators in the pharmaceutical industry, and patenting is typically central to their success. This article aims to explore patent management in pharmaceutical startups. The results show that startups need to deal with several challenges related to patenting and an 'entrepreneurial' approach to patent management is called for. Resource constraints, venture capital provision, exits and other conditions and events must be readily considered in the patent management process to build a successful pharmaceutical venture, something that could benefit the pharmaceutical industry as a whole. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Proposed changes to the reimbursement of pharmaceuticals and medical devices in Poland and their impact on market access and the pharmaceutical industry

    Science.gov (United States)

    Badora, Karolina; Caban, Aleksandra; Rémuzat, Cécile; Dussart, Claude; Toumi, Mondher

    2017-01-01

    ABSTRACT In Poland, two proposed amendments to the reimbursement act are currently in preparation; these are likely to substantially change the pricing and reimbursement landscape for both drugs and medical devices. Proposed changes include: alignment of medical device reimbursement with that of pharmaceuticals; relaxing the strict reimbursement criteria for ultra-orphan drugs; establishment of an additional funding category for vaccines; introduction of compassionate use, and a simplified reimbursement pathway for well-established off-label indications; appreciation of manufacturers’ innovation and research and development efforts by creating a dedicated innovation budget; introduction of a mechanism preventing excessive parallel import; prolonged duration of reimbursement decisions and reimbursement lists; and increased flexibility in defining drug programmes. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. Nonetheless, the overall direction of some of the changes is already evident and warrants discussion due to their high expected impact on pharmaceutical and device manufacturers. Here we evaluate the main changes proposed to the reimbursement of drugs, vaccines, and medical devices, and examine the impact they are likely to have on market access and pharmaceutical industry in Poland. PMID:29081924

  5. Effects of benfotiamine and coenzyme Q10 on kidney damage induced gentamicin.

    Science.gov (United States)

    Ustuner, Mehmet Alperen; Kaman, Dilara; Colakoglu, Neriman

    2017-12-01

    Gentamicin (GM) is an effective antibiotic against severe infection but has limitations related to nephrotoxicity. In this study, we investigated whether benfotiamine (BFT) and coenzyme Q10 (CoQ10), could ameliorate the nephrotoxic effect of GM in rats. Rats were divided into five groups. Group 1 and 2 served as control and sham respectively, Group 3 as GM group, Group 4 as GM+CoQ10 and Group 5 as GM+BFT for 8days. At the end of the study, all rats were euthanized by cervical decapitation and then blood samples and kidneys were collected for further analysis. Serum urea, creatinine, cytokine TNF-a, oxidant and antioxidant parameters, as well as histopathological examination of kidney tissues were assessed. Gentamicin administration caused a severe nephrotoxicity which was evidenced by an elevated serum creatinine, urea and KIM-1 level as compared with the controls. Moreover, a significant increase in serum malondialdehyde, reduced glutathione. Histopathological examination of renal tissue in gentamisin administered group, there were extremly pronounced necrotic tubules in the renal cortex and hyalen cast accumulation in the medullar tubuli. BFT given to GM rats reduced these nephrotoxicity parameters. Serum creatinine, urea, and KIM-1 were almost normalized in the GM+BFT group. Benfotiamin treatment was significantly decreased necrotic tubuli and hyalen deposition in gentamisin plus benfotiamin group. CoQ10 given to GM rats did not cause any statistically significant alterations in these nephrotoxicity parameters when compared with GM group but histopathological examination of renal tissue in GM+CoQ10 administered group, CoQ10 treatment was decreased necrotic tubuli rate and hyalen accumulation in tubuli. The results from our study indicate that BFT supplement attenuates gentamicin-induced renal injury via the amelioration of oxidative stress and inflammation of renal tubular cells. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. Supply Chain Management in Zhendong Pharmaceutical Company

    OpenAIRE

    Li, Yan

    2011-01-01

    Medicines are special commodity related to people’s lives and health, therefore, pharmaceutical distribution is an industry affecting the national economy and the people's livelihood. With health care reform, changeable pharmaceutical policy and fiercely increasing competition in the medical industry, pharmaceutical distribution companies should improve their level of logistics operations and reduce overall logistics management costs in order to gain a leading position in the competition. In ...

  7. Investigating the turnover of middle and senior managers in the pharmaceutical industry in South Africa

    Directory of Open Access Journals (Sweden)

    Abofele Khoele

    2014-08-01

    Full Text Available Orientation: Today, knowledge is a commodity and thus skilled knowledge workers, particularly in management positions, are vital for organisations’ success; their increased turnover has an adverse effect on productivity and profitability. High staff turnover is a cause for alarm, not only because of the costs associated with recruitment, selection and training, but also due to the increasing scarcity of experienced talent. Research purpose: This research investigates the reasons for the turnover of middle and senior managers in the pharmaceutical industry in South Africa in order to identify the possible reasons and formulate solutions to address the issue. Motivation for the study: In South Africa, employment, retention and turnover occur against the backdrop of a history of discrimination and inequality and attempts by government and organisations at redress. The significance of this background cannot be underestimated. Research approach, design and method: This study was qualitative and inductive to allow dominant themes to emerge from the raw data. Data was collected through in-depth, semi-structured one-on-one interviews as well as a review of company turnover reports and employment equity reports. Main findings: The study found that in the sampled organisations, employee turnover averaged almost 22% per annum between 2007 and 2010. Reasons for the turnover include a range of industry, company and personal factors. Practical/managerial implications: The overall turnover rate remains high, particularly amongst black knowledge workers, the attraction, recruitment and retention of whom is as important for addressing historical inequities in the local industry as it is for ensuring the diversity that companies need to reach a bigger market and gain a competitive edge. Further, as government is a significant purchaser of pharmaceutical goods and services, companies must ensure that the required Black Economic Empowerment (BEE rating level is

  8. Analysis on Time-Lag Effect of Research and Development Investment in the Pharmaceutical Industry in Korea.

    Science.gov (United States)

    Lee, Munjae; Choi, Mankyu

    2015-08-01

    The aim of this study is to analyze the influence of the research and development (R&D) investment of pharmaceutical companies on enterprise value. The period of the empirical analysis is from 2000 to 2012, considering the period after the influence of the financial crisis. Financial statements and comments in general and internal transactions were extracted from TS-2000 of the Korea Listed Company Association, and data related to stock price were extracted from KISVALUE-III of National Information and Credit Evaluation Information Service Co., Ltd. STATA 12.0 was used as the statistical package for panel analysis. In the pharmaceutical firms, the influence of the R&D intensity with regard to Tobin's q was found to be positive. However, only the R&D expenditure intensities of previous years 2 and 5 (t-2 and t-5, respectively) were statistically significant (p company, such as generic, incrementally modified drugs, and biosimilar products.

  9. Coenzyme Q10 Supplementation Modulates NFκB and Nrf2 Pathways in Exercise Training

    Directory of Open Access Journals (Sweden)

    Ragip Pala, Cemal Orhan, Mehmet Tuzcu, Nurhan Sahin, Shakir Ali, Vedat Cinar, Mustafa Atalay, Kazim Sahin

    2016-03-01

    Full Text Available This study reports the effects of Q10, coenzyme Q10 or ubiquinone, a component of the electron transport chain in mitochondria, on nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB, inhibitors of kappa B (IκB, nuclear factor (erythroid-derived 2-like 2 (Nrf2 and hemeoxygenase 1 (HO-1 in rats after chronic exercise training for 6 weeks. 8-week old male Wistar rats were assigned randomly to one of four treatments planned in a 2 x 2 factorial arrangement of two condition (sedentary vs. exercise training, and two coenzyme Q10 levels (0 and 300 mg/kg per day for 6 weeks. The expression levels of the target proteins were determined in the heart, liver and muscle, and biochemical parameters including creatinine, urea, glucose and lipid profile were investigated in plasma. When compared with sedentary group, significant decreases in heart, liver and muscle NFκB levels by 45%, 26% and 44% were observed in Q10 supplemented rats after exercise training, respectively, while the inhibitory protein IκB increased by 179%, 111% and 127% in heart, liver and muscle tissues. Q10 supplementation caused an increase in Nrf2 (167%, 165% and 90% and HO-1 (107%, 156% and 114% after exercise training in heart, liver and muscle tissues (p < 0.05. No significant change was observed in any of the parameters associated with protein, carbohydrate and lipid metabolism, except that exercise caused a decrease in plasma triglyceride, which was further decreased by Q10. In conclusion, these results suggest that Q10 modulates the expression of NFκB, IκB, Nrf2 and HO-1 in exercise training, indicating an anti-inflammatory effect of Q10 and emphasizes its role in antioxidant defense.

  10. Assessment of Food Processing and Pharmaceutical Industrial Wastes as Potential Biosorbents: A Review

    OpenAIRE

    El-Sayed, Hanan E. M.; El-Sayed, Mayyada M. H.

    2014-01-01

    There is a growing need for the use of low-cost and ecofriendly adsorbents in water/wastewater treatment applications. Conventional adsorbents as well as biosorbents from different natural and agricultural sources have been extensively studied and reviewed. However, there is a lack of reviews on biosorption utilizing industrial wastes, particularly those of food processing and pharmaceuticals. The current review evaluates the potential of these wastes as biosorbents for the removal of some ha...

  11. PHARMACEUTICAL COMPANIES BETWEEN CRISIS AND COMPETITIVENESS - SECTORAL DIAGNOSIS

    Directory of Open Access Journals (Sweden)

    Mihaela\tBÎRSAN

    2015-06-01

    Full Text Available The evolution of the pharmaceutical industry was a positive constant with the indicators of industrial production even in years of crisis. Although the economic crisis in Romania decreased average growth rate of pharmaceutical companies, market value is expected to increase. The explanation comes from the fact that in order to boost productivity, pharmaceutical companies are turning to emerging countries with aging populations such as open new markets for future development. Add to this the recent health policies implemented by newly industrialized countries that are aimed at ensuring increased access to care. Analysts see the field phenomenon called "Farma-merger" a good chance for European pharmaceutical companies oriented to developing countries where drug sales should record a double-digit annual growth until 2017. In Erste Group reports stated that the impact of the crisis on the pharmaceutical industry should be limited markets for EU only their economic slowdown. This will be possible because the external indebtedness of pharmaceutical companies in the EU remains at a minimum, they are able to finance their investment plans without tapping financial markets, are not adversely affected by the current limited availability of credit resources. Therefore major pharmaceutical companies in the EU will remain a solid investment on the long term, the negative developments are limited due to high resistance to the crisis their business model segment "generic". The consequence of these developments is reflected in the recognition for the first time, the pharmaceutical sector as a strategic sector for the Romanian economy. In the context of public debate launching the National Strategy for Competitiveness 2014-2020, Generic Medicines Industry Association of Romania (APMGR local pharmaceutical industry reminds the Government proposals on correcting the current fiscal and operational regulatory framework, to allow unlocking investments in facilities

  12. Biocatalytic Synthesis of Chiral Pharmaceutical Intermediates

    Directory of Open Access Journals (Sweden)

    Ramesh N. Patel

    2004-01-01

    Full Text Available The production of single enantiomers of drug intermediates has become increasingly important in the pharmaceutical industry. Chiral intermediates and fine chemicals are in high demand from both the pharmaceutical and agrochemical industries for the preparation of bulk drug substances and agricultural products. The enormous potential of microorganisms and enzymes for the transformation of synthetic chemicals with high chemo-, regio- and enantioselectivities has been demonstrated. In this article, biocatalytic processes are described for the synthesis of chiral pharmaceutical intermediates.

  13. Water-soluble coenzyme Q10 formulation (Q-TER(®)) in the treatment of presbycusis.

    Science.gov (United States)

    Salami, Angelo; Mora, Renzo; Dellepiane, Massimo; Manini, Giorgio; Santomauro, Valentina; Barettini, Luciano; Guastini, Luca

    2010-10-01

    These preliminary data are encouraging for a larger clinical trial to collect additional evidence on the effect of Q-TER(®) in preventing the development of hearing loss in subjects with presbycusis. The purpose of this study was to evaluate the efficiency and applicability of a water-soluble formulation of CoQ10 (Q-TER(®)) in subjects with presbycusis. A total of 60 patients with presbycusis were included and divided into three numerically equal groups. Group A underwent therapy with Q-TER(®), 160 mg, once a day for 30 days; group B underwent therapy with vitamin E (50 mg), once a day for 30 days; group C received placebo, once a day for 30 days. Before and at the end of the treatment, all patients underwent pure tone audiometry, transient evoked otoacoustic emissions, otoacoustic products of distortion, auditory brainstem response, and speech audiometry. Compared with group B, at the end of the treatment in group A the liminar tonal audiometry showed a significant improvement of the air and bone thresholds at the 1000 (14/20 vs 9/20), 2000 (14/20 vs 7/20), 4000 (15/20 vs 6/20), and 8000 Hz (13/20 vs 5/20). We found no significant differences in the other parameters and in group C.

  14. Temperature-related changes in respiration and Q10 coefficient of Guava

    Directory of Open Access Journals (Sweden)

    Bron Ilana Urbano

    2005-01-01

    Full Text Available Guava (Psidium guajava L. is a tropical fruit that presents fast post-harvest ripening; therefore it is a very perishable product. Inappropriate storage temperature and retail practices can accelerate fruit quality loss. The objective of this study was to evaluate the respiratory activity (RA, the ethylene production (EP and Q10 of guava fruit at different storage temperatures. 'Paluma' guava fruits were harvested at maturity stage 1 (dark-green skin and stored at either 1, 11, 21, 31 or 41ºC; RA and EP were determined after 12, 36, 84 and 156 h of storage. RA and EP rates at 1 and 11ºC were the lowest - 0.16 and 0.43 mmol CO2 kg-1 h-1 and 0.003 and 0.019 µmol C2H4 kg-1 h-1, respectively. When guavas were stored at 21ºC, a gradual increase occurred in RA and EP, reaching 2.24 mmol CO2 kg-1 h-1 and 0.20 µmol C2H4 kg-1 h-1, after 156 h of storage. The highest RA and EP were recorded for guavas stored at 31ºC. In spite of high RA, guavas stored at 41ºC presented EP similar to guavas stored at 11ºC, an indicator of heat-stress injury. Considering the 1-11ºC range, the mean Q10 value was around 3.0; the Q10 value almost duplicated at 11-21ºC range (5.9. At 21-31ºC and 31-41ºC, Q10 was 1.5 and 0.8, respectively. Knowing Q10, respiratory variation and ripening behavior in response to different temperatures, fruit storage and retail conditions can be optimized to reduce quality losses.

  15. High sensitive multiresidue analysis of pharmaceuticals and antifungals in surface water using U-HPLC-Q-Exactive Orbitrap HRMS. Application to the Danube river basin on the Romanian territory

    NARCIS (Netherlands)

    Chitescu, C.L.; Kaklamanos, George; Nicolau, A.I.; Stolker, Linda

    2015-01-01

    The occurrence of 67 pharmaceutical and antifungal residues in the Danube river on the Romanian territory was studied by using solid-phase extraction (SPE) and LC-Q Exactive Orbitrap high resolution MS in both full scan (FS) MS and targeted MS/MS modes. A single-laboratory validation procedure

  16. Effect of coenzyme q10 on myopathic symptoms in patients treated with statins.

    Science.gov (United States)

    Caso, Giuseppe; Kelly, Patricia; McNurlan, Margaret A; Lawson, William E

    2007-05-15

    Treatment of hypercholesterolemia with statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) is effective in the primary and secondary prevention of cardiovascular disease. However, statin use is often associated with a variety of muscle-related symptoms or myopathies. Myopathy may be related in part to statin inhibition of the endogenous synthesis of coenzyme Q10, an essential cofactor for mitochondrial energy production. The aim of this study is to determine whether coenzyme Q10 supplementation would reduce the degree of muscle pain associated with statin treatment. Patients with myopathic symptoms were randomly assigned in a double-blinded protocol to treatment with coenzyme Q10 (100 mg/day, n = 18) or vitamin E (400 IU/day, n = 14) for 30 days. Muscle pain and pain interference with daily activities were assessed before and after treatment. After a 30-day intervention, pain severity decreased by 40% (p pain interference with daily activities decreased by 38% (p pain severity (+9%, p = NS) or pain interference with daily activities (-11%, p = NS) was observed in the group treated with vitamin E. In conclusion, results suggest that coenzyme Q10 supplementation may decrease muscle pain associated with statin treatment. Thus, coenzyme Q10 supplementation may offer an alternative to stopping treatment with these vital drugs.

  17. Coenzyme Q10 Supplementation Decreases Statin-Related Mild-to-Moderate Muscle Symptoms: A Randomized Clinical Study

    OpenAIRE

    Skarlovnik, Ajda; Janić, Miodrag; Lunder, Mojca; Turk, Martina; Šabovič, Mišo

    2014-01-01

    Background Statin use is frequently associated with muscle-related symptoms. Coenzyme Q10 supplementation has yielded conflicting results in decreasing statin myopathy. Herein, we tested whether coenzyme Q10 supplementation could decrease statin-associated muscular pain in a specific group of patients with mild-to-moderate muscle symptoms. Material/Methods Fifty patients treated with statins and reporting muscle pain were recruited. The Q10 group (n=25) received coenzyme Q10 supplementation o...

  18. Organizing Global IS Management to Meet Competitive Challenges: Experiences from the Pharmaceutical Industry

    OpenAIRE

    Bettina Schwarzer

    1995-01-01

    Despite the widely acknowledged importance information technology plays in multinational corporations, many companies lack an understanding of when and how to (re)organize global IS management. The issues of timing and organization of global IS management, however, seem to be of utmost importance in a company’s attempt to implement a new, global business strategy. Based on three case studies from the pharmaceutical industry, this paper analyzes the sequence in which business strategy, organ...

  19. The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school.

    Science.gov (United States)

    Stanley, A G; Jackson, D; Barnett, D B

    2005-04-01

    Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK.

  20. Introduction: Institutional corruption and the pharmaceutical policy.

    Science.gov (United States)

    Rodwin, Marc A

    2013-01-01

    Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. © 2013 American Society of Law, Medicine & Ethics, Inc.

  1. THERMODYNAMIC PROPERTIES OF NONAQUEOUS SINGLE SALT SOLUTIONS USING THE Q-ELECTROLATTICE EQUATION OF STATE

    Directory of Open Access Journals (Sweden)

    A. Zuber

    2015-09-01

    Full Text Available AbstractThe correlation of thermodynamic properties of nonaqueous electrolyte solutions is relevant to design and operation of many chemical processes, as in fertilizer production and the pharmaceutical industry. In this work, the Q-electrolattice equation of state (EOS is used to model vapor pressure, mean ionic activity coefficient, osmotic coefficient, and liquid density of sixteen methanol and ten ethanol solutions containing single strong 1:1 and 2:1 salts. The Q-electrolattice comprises the lattice-based Mattedi-Tavares-Castier (MTC EOS, the Born term and the explicit MSA term. The model requires two adjustable parameters per ion, namely the ionic diameter and the solvent-ion interaction energy. Predictions of osmotic coefficient at 298.15 K and liquid density at different temperatures are also presented.

  2. Traceability in the pharmaceutical industry: application to radiopharmaceutical production

    International Nuclear Information System (INIS)

    Zanette, Camila; Melero, Laura T.U.H.; Araujo, Elaine B. de; Mengatti, Jair; Silva, Katia S. de S.

    2011-01-01

    The development of tools to promote the traceability of the drugs in the pharmaceutical industry during all the production chain is a necessary requisite. The traceability system is applied to enable the identification of the origin, destination and exact location of the drug. Traceability optimizes the process chain, reduces errors, is a requirement for quality process, promotes safety for the user and assists in pharmacovigilance. The health regulatory agency in Brazil (ANVISA) will implement a tracking system for medicaments with RDC no. 59 of 2009, to control distribution since the producer until the patients in order to prevent the traffic and adulteration of drugs. Thus, this study discusses the importance and impact of the new traceability system proposed by ANVISA in the production and distribution of radiopharmaceuticals from the Nuclear and Energy Research Institute (IPEN-CNEN). The radiopharmaceuticals have a difference track when compared with another drug classes. In this context, this RDC would increase the price of the medicines by up to 10%, since it provides deployment of a single stamp supplied by the Mint. Considering that radiopharmaceuticals are not sold to the final consumer (patients), but only for accredited medical clinics and nuclear medicine physicians, and the transport of radiopharmaceuticals is performed by specialized companies licensed by CNEN (National Nuclear Energy Commission), the use of the stamp to ensure authenticity and prevent falsification should not be appropriated and represents and additional cost for the radiopharmaceuticals. (author)

  3. Coenzyme Q10 protects retinal cells from apoptosis induced by radiation in vitro and in vivo

    International Nuclear Information System (INIS)

    Lulli, M.; Witort, E.; Papucci, L.; Torre, E.; Schiavone, N.; Capaccioli, S.; Dal Monte, M.

    2012-01-01

    The key pathogenetic event of many retinopathies is apoptosis of retinal cells. Our previous studies have demonstrated that Coenzyme Q10 (CoQ10) prevents apoptosis of corneal keratocytes both in vitro and in vivo, by virtue of its ability to inhibit mitochondrial depolarization, independently of its free radical scavenger role. The aim of this study was to evaluate whether CoQ10 can protect cultured retinal cells and the retinas of rats from radiation-induced apoptosis, if instilled as eye drops in the cornea. In vitro experiments were carried out on cultured ARPE-19 or retinal ganglion cells (RGC)-5 cells pretreated with CoQ10 before eliciting apoptosis by ultraviolet (UV)- and γ-radiation, chemical hypoxia (Antimycin A) and serum starvation. Cell viability was evaluated by light microscopy and fluorescence activated cell sorting analysis. Apoptotic events were scored by time-lapse videomicroscopy. Mitochondrial permeability transition was evaluated by JC-1. The anti-apoptotic effectiveness of CoQ10 in retina was also evaluated by an in situ end-labeling assay in Wistar albino rats treated with CoQ10 eye drops prior to UV irradiation of the eye. CoQ10 substantially increased cell viability and lowered retinal cell apoptosis in response both to UV- and γ-radiation and to chemical hypoxia or serum starvation by inhibiting mitochondrion depolarization. In the rat, CoQ10, even when applied as eye drops on the cornea, protected all retina layers from ultraviolet radiation (UVR)-induced apoptosis. The ability of CoQ10 to protect retinal cells from radiation-induced apoptosis following its instillation on the cornea suggests the possibility for CoQ10 eye drops to become a future therapeutic countermeasure for radiation-induced retinal lesions. (author)

  4. API Specification Q1: The quality system specification for the oil and gas industry

    International Nuclear Information System (INIS)

    Peurifoy, C.K.

    1994-01-01

    The Oil and Gas Production Industry began using the American Petroleum Institute's Specification Q1, ''Specification for Quality Programs'' (1st Edition, January 1, 1985) in late 1984. The generic ISO 9000 Series Standards, ''Quality management and quality assurance standards,'' were developed at about the same time and were published for public use in 1987. By late 1989 and into the early nineties, the formation of the European Economic Community and the issuance of the EC Procurement Directives sparked a rush by companies worldwide to comply with all the requirements necessary to do business in Europe. The ensuing ''ISO Mania'' has created a windfall for any company providing ISO 9000 quality system certification, consulting, training and almost anything to do with ISO 9000. It is difficult to miss one of the hundreds of newspaper and trade magazine articles promoting the ISO 9000 Quality Standards for use in almost every industry. This paper discusses the latest developments of both the lesser known API Spec Q1 and the much publicized ISO 9001 as well as discusses some of the similarities and differences between them and possible future trends. It also reviews some of the strengths and weaknesses of both documents to support the sentiment that API Spec Q1, in conjunction with the API Monogram Program, is the best quality standard for use in ordering equipment, materials and services for the Oil and Gas Industry

  5. Direct-to-consumer communication on prescription only medicines via the internet in the Netherlands, a pilot study. Opinion of the pharmaceutical industry, patient associations and support groups.

    Science.gov (United States)

    Fabius, A Mariette; Cheung, Ka-Chun; Rijcken, Cristianne J F; Vinkers, Christiaan H; Talsma, Herre

    2004-06-01

    Investigation of the current application of direct-to-consumer (DTC) communication on prescription only medicines via the Intemet in the Netherlands. Questionnaires were sent by e-mail to 43 Dutch innovative pharmaceutical industries and 130 Patient Association and Support Groups (PASGs). In this pilot study, the response of the pharmaceutical industry was rather low but the impression is that they were willing to invest in DTC communication. The majority of the websites of PASGs did not link to websites of pharmaceutical companies. The PASGs had no opinion whether patients can make a good distinction between DTC advertising and information on websites of the pharmaceutical industry nor about the quality. PASGs did not think unambiguously about the impact on the patient-doctor relationship. The impact of DTC communication on prescription only medicines via the internet is not yet clear in the Netherlands.

  6. Pharmacoligaclly Active: Clinical Trials and the Pharmaceuticals ...

    African Journals Online (AJOL)

    Multinational pharmaceutical companies ('pharmas') import and produce pharmaceuticals and also conduct clinical trials which are an important aspect of research and development (R&D). This may raise the question: Is South Africa a guinea pig for the pharmas? The Department of Trade and Industry National Industrial ...

  7. A lesson from Japan: research and development efficiency is a key element of pharmaceutical industry consolidation process.

    Science.gov (United States)

    Shimura, Hirohisa; Masuda, Sachiko; Kimura, Hiromichi

    2014-02-01

    Scholarly attention to pharmaceutical companies' ability to sustain research and development (R&D) productivity has increased as they increasingly handle business challenges. Furthermore, the deterioration of R&D productivity has long been considered a major cause of mergers and acquisitions (M&As). This study attempts to investigate quantitatively the possible causes of the deterioration and the relationship between the deterioration and M&As by examining the Japanese pharmaceutical industry. Japan from 1980 to 1997 is an ideal case because of the availability of official data, but more importantly the significant changes in its business environment at the time. Using the Malmquist Index and data envelopment analysis, we measured the deterioration of R&D productivity from 1980 to 1997 based on a sample of 15 Japanese companies. Two lessons can be learned from Japan's case. First, to sustain R&D productivity over the long term, companies should use licensing activities and focus on the dominant therapeutic franchises. Second, if a company fails significantly to catch up with the benchmark, it is likely to pursue an M&A or seek an alternative way to improve R&D productivity. These findings appear similar to the current situation of the global pharmaceutical industry, although Japan pursued more licensing activities than M&A to improve R&D productivity.

  8. New applications to computerized tomography: analysis of solid dosage forms produced by pharmaceutical industry

    International Nuclear Information System (INIS)

    Oliveira Junior, Jose Martins de; Martins, Antonio Cesar Germano

    2009-01-01

    Full text: In recent years, computerized tomography (CT) has been used as a new probe to study solid dosage forms (tablets) produced by pharmaceutical industry. This new approach to study tablet and powder, or granulation, properties used in pharmaceutical industry is very suitable. First because CT can generate information that traditional technologies used in this kind of analysis can not, such as, density distribution of internal structures and tablet dimensions, pore size distribution, particle shape information, and also investigation of official and unofficial (counterfeit) copies of solid dosage forms. Second because CT is a nondestructive technique, allowing the use of tablets or granules in others analysis. In this work we discus how CT can be used to acquire and reconstruct internal microstructure of tablets and granules. CT is a technique that is based on attenuation of X-rays passing through matter. Attenuation depends on the density and atomic number of the material that is scanned. In this work, a micro-CT X-ray scanner (manufactured by the group of Applied Nuclear Physics at University of Sorocaba) was used to obtain three-dimensional images of the tablets and granules for nondestructive analysis. These images showed a non uniform density distribution of material inside some tablets, the morphology of some granules analyzed, the integrity of the liquid-filled soft-gelatin capsule and so on. It could also be observed that the distribution of different constituents presents an osmotic controlled-release dosage form. The present work shows that it is possible to use X-ray microtomography to obtain useful qualitative and quantitative information on the structure of pharmaceutical dosage forms. (author)

  9. American Academy of Neurology policy on pharmaceutical and device industry support.

    Science.gov (United States)

    Hutchins, J C; Rydell, C M; Griggs, R C; Sagsveen, M; Bernat, J L

    2012-03-06

    To examine the American Academy of Neurology (AAN)'s prevention and limitation of conflicts of interest (COI) related to relationships with pharmaceutical and medical device manufacturers and other medically related commercial product and service companies (industry). We reviewed the AAN's polices governing its interactions with industry, mechanisms for enforcement, and the recent findings of the board-appointed COI task force, in the context of the 2009 David Rothman and colleagues' article in JAMA, the Council of Medical Specialty Societies (CMSS) Code for Interactions with Companies (Code), efforts of the American Medical Association in this area, and increased public and Congressional scrutiny of physician/physician organizations' relationships with industry. The AAN's Policy on Conflicts of Interest provides 4 mechanisms for addressing COI: avoidance, separation, disclosure, and regulation. The AAN's Principles Governing Academy Relationships with External Sources of Support, including recent amendments proposed by the COI task force, regulate industry interaction with AAN programming, products, and leadership. With the Policy, Principles, and other methods of COI prevention, the AAN meets or exceeds all recommendations of the CMSS Code. With its adherence to the Principles since 2004, the AAN has been a leader among professional medical associations in appropriately managing COI related to interactions with industry. Recent amendments to the Principles maintain the AAN's position as a leader in a time of increased public scrutiny of physicians' and professional medical associations' relationships with industry. The AAN is responsive to the recommendations of the COI task force, and has adopted the CMSS Code.

  10. The ethics of the medical-pharmaceutical relationship.

    Science.gov (United States)

    Vashi, Neelam A; Latkowski, Jo-Ann M

    2012-01-01

    Physician interaction with the pharmaceutical industry raises many ethical concerns. This relationship is complex, owing to a pluralism of beliefs held by physicians, patients, and third parties. As a result, determining whether physicians fulfill their responsibilities to both the professional and public communities is an arduous endeavor. In an effort to clarify the situation and provide transparency to this complex relationship, medical and pharmaceutical organizations have enacted their own respective codes and guidelines. Even with adherence to these guidelines, questions remain regarding the codependent relationship that interweaves the pharmaceutical industry with the medical community. Owing to the ever-changing landscape enmeshing product development, scientific advancement, corporate realities and patient care, the proper choice for physicians is rarely obvious; however, to operate to the highest standards, those in the medical community must be candid about relations with the pharmaceutical industry and transparent in their financial interests. Further undertakings should focus not on the eradication of physician-pharmaceutical interaction, but instead on the education of physicians about industry marketing strategies and the delineation of boundaries of these interactions to benefit not the individual physician, but our patients. Copyright © 2012. Published by Elsevier Inc.

  11. Patent cliff and strategic switch: exploring strategic design possibilities in the pharmaceutical industry.

    Science.gov (United States)

    Song, Chie Hoon; Han, Jeung-Whan

    2016-01-01

    Extending the period of the market exclusivity and responding properly to the recent agglomeration of patent expiries are pivotal to the success of pharmaceutical companies. Declining R&D productivity, rising costs of commercialization, near-term patent expirations for many top-selling drugs are forcing companies to adopt new systems to introduce innovative products to market and to focus on strategies that increase the returns from the existing product portfolio. This systematic review explores various strategic and tactical management approaches by synthesizing the relevant literature and practical examples on patent expiration strategies. It further discusses how the mix of competition policies and strategic instruments can be used to maintain declining revenue streams from the blockbuster business model of the pharmaceutical industry. The review provides a comprehensive overview of the research on various strategies, offers both theoretical and practical guidelines for strategy transformation that companies can use to prolong the market exclusivity, and identifies knowledge gaps that needed to be addressed in order to improve efficiency in policy design.

  12. CoQ10 Deficiency May Indicate Mitochondrial Dysfunction in Cr(VI Toxicity

    Directory of Open Access Journals (Sweden)

    Xiali Zhong

    2017-04-01

    Full Text Available To investigate the toxic mechanism of hexavalent chromium Cr(VI and search for an antidote for Cr(VI-induced cytotoxicity, a study of mitochondrial dysfunction induced by Cr(VI and cell survival by recovering mitochondrial function was performed. In the present study, we found that the gene expression of electron transfer flavoprotein dehydrogenase (ETFDH was strongly downregulated by Cr(VI exposure. The levels of coenzyme 10 (CoQ10 and mitochondrial biogenesis presented by mitochondrial mass and mitochondrial DNA copy number were also significantly reduced after Cr(VI exposure. The subsequent, Cr(VI-induced mitochondrial damage and apoptosis were characterized by reactive oxygen species (ROS accumulation, caspase-3 and caspase-9 activation, decreased superoxide dismutase (SOD and ATP production, increased methane dicarboxylic aldehyde (MDA content, mitochondrial membrane depolarization and mitochondrial permeability transition pore (MPTP opening, increased Ca2+ levels, Cyt c release, decreased Bcl-2 expression, and significantly elevated Bax expression. The Cr(VI-induced deleterious changes were attenuated by pretreatment with CoQ10 in L-02 hepatocytes. These data suggest that Cr(VI induces CoQ10 deficiency in L-02 hepatocytes, indicating that this deficiency may be a biomarker of mitochondrial dysfunction in Cr(VI poisoning and that exogenous administration of CoQ10 may restore mitochondrial function and protect the liver from Cr(VI exposure.

  13. Windows of opportunities and technological innovation in the Brazilian pharmaceutical industry.

    Science.gov (United States)

    Tigre, Paulo Bastos; Nascimento, Caio Victor Machado França do; Costa, Laís Silveira

    2016-11-03

    The Brazilian pharmaceutical industry is heavily dependent on external sources of inputs, capital, and technology. However, the emergence of technological opportunities and the development of biotechnology and the decline of the patent boom and resulting advances by generic drugs have opened windows of opportunities for the local industry. The article examines the Brazilian industry's innovative behavior vis-à-vis these opportunities, showing that although the industry as a whole invests little in innovation, a few large Brazilian companies have expanded their market share and stepped up their investments in research and development, supported by public policies for innovation. Resumo: A indústria farmacêutica brasileira caracteriza-se pela grande dependência de fontes externas de insumos, capital e tecnologia. O surgimento de oportunidades tecnológicas, associadas ao desenvolvimento da biotecnologia e ao fim do boom das patentes com o consequente avanço dos medicamentos genéricos, entretanto, vem abrindo janelas de oportunidades para a indústria local. Este artigo examina o comportamento inovador da indústria brasileira à luz dessas oportunidades, revelando que, embora o conjunto da indústria mantenha baixos níveis de investimentos em inovação, um pequeno grupo de grandes empresas nacionais vem ampliando sua participação no mercado e intensificando seus investimentos em pesquisa e desenvolvimento, apoiados por políticas públicas de inovação.

  14. Interaction of Coenzyme Q10 with Liposomes and its Impact on Suppression of Selenite – Induced Experimental Cataract

    Directory of Open Access Journals (Sweden)

    Medhat Wahba Shafaa

    2018-03-01

    Full Text Available Purpose: To stress the influence of Coenzyme Q10 (CoQ10 on the structural properties of liposomes as model membranes and to investigate the possible role of CoQ10 or CoQ10 doped in liposomes when topically instilled as eye drops, in preventing cataract. Methods: The molecular interaction between liposomes and Coenzyme Q10 was examined using differential scanning calorimetry (DSC and Fourier transform infrared spectroscopy (FTIR. Rat pups were randomly divided into six groups comprising 15 pups. Group (1, control group. Group (2, untreated model of cataract, received a single subcutaneous injection of sodium selenite. Instillation of pure CoQ10 (Group 3, CoQ10 encapsulated into neutral (Group 4, positive (Group 5 and negative (Group 6 Dipalmitoyl phosphatidylcholine (DPPC liposomes on the opacification of lenses in rat pups after sodium selenite injection was topically received. Results: The incorporated CoQ10 is probably associated with lipid bilayers where it interacts to a large extent and perturbs them. This results in strong broadening and shift to lower temperature (94°C of the major characteristic endothermic peak of pure DPPC at 105°C. FTIR showed that the incorporation of CoQ10 into DPPC induces a conformational change in the polar region of DPPC. Ophthalmological and Biochemical studies revealed that CoQ10 alone followed by negatively charged liposomes doped with CoQ10 are more effective in reducing the progress of cataract as well as improving the lens soluble proteins levels and total antioxidant capacity. Conclusion: The interactions of CoQ10 with membrane systems may contribute to a better understanding of CoQ10 physiological properties and the development of therapeutically advanced systems.

  15. Coenzyme Q10 does not prevent oral dyskinesias induced by long-term haloperidol treatment of rats

    DEFF Research Database (Denmark)

    OA, Andreassen; Weber, Christine; HA, Jorgensen

    1999-01-01

    dyskinesias in rats, a putative analogue to human TD, could be prevented by the antioxidant coenzyme Q10 (CoQ10). Rats received 16 weeks of treatment with haloperidol decanoate (HAL) IM alone or together with orally administered CoQ10, and the behavior was recorded during and after treatment. HAL...

  16. Coenzyme Q10 supplementation decreases statin-related mild-to-moderate muscle symptoms: a randomized clinical study.

    Science.gov (United States)

    Skarlovnik, Ajda; Janić, Miodrag; Lunder, Mojca; Turk, Martina; Šabovič, Mišo

    2014-11-06

    Statin use is frequently associated with muscle-related symptoms. Coenzyme Q10 supplementation has yielded conflicting results in decreasing statin myopathy. Herein, we tested whether coenzyme Q10 supplementation could decrease statin-associated muscular pain in a specific group of patients with mild-to-moderate muscle symptoms. Fifty patients treated with statins and reporting muscle pain were recruited. The Q10 group (n=25) received coenzyme Q10 supplementation over a period of 30 days (50 mg twice daily), and the control group (n=25) received placebo. The Brief Pain Inventory (BPI) questionnaire was used and blood testing was performed at inclusion in the study and after 30 days of supplementation. The intensity of muscle pain, measured as the Pain Severity Score (PSS), in the Q10 group was reduced from 3.9±0.4 to 2.9±0.4 (PPain Interference Score (PIS) after Q10 supplementation was reduced from 4.0±0.4 to 2.6±0.4 (Pstatin-related muscle symptoms in 75% of patients. The relative values of PSS and PIS significantly decreased (-33.1% and -40.3%, respectively) in the Q10 group compared to placebo group (both Pmuscle enzymes or cholesterol values were found. The present results show that coenzyme Q10 supplementation (50 mg twice daily) effectively reduced statin-related mild-to-moderate muscular symptoms, causing lower interference of statin-related muscular symptoms with daily activities.

  17. Effects of Coenzyme Q10 on Markers of Inflammation: A Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Junya Zhai

    Full Text Available Chronic inflammation contributes to the onset and development of metabolic diseases. Clinical evidence has suggested that coenzyme Q10 (CoQ10 has some effects on inflammatory markers. However, these results are equivocal. The aim of this systematic review was to assess the effects of CoQ10 on serum levels of inflammatory markers in people with metabolic diseases.Electronic databases were searched up to February 2016 for randomized controlled trials (RCTs. The outcome parameters were related to inflammatory factors, including interleukin-6 (IL-6, tumor necrosis factor-alpha (TNF-α and C reactive protein (CRP. RevMan software was used for meta-analysis. Meta-regression analysis, Egger line regression test and Begg rank correlation test were performed by STATA software.Nine trials involving 428 subjects were included in this meta-analysis. The results showed that compared with control group, CoQ10 supplementation has significantly improved the serum level of CoQ10 by 1.17μg/ml [MD = 1.17, 95% CI (0.47 to 1.87 μg/ml, I2 = 94%]. Meanwhile, it has significantly decreased TNF-α by 0.45 pg/ml [MD = -0.45, 95% CI (-0.67 to -0.24 pg/ml, I2 = 0%]. No significant difference was observed between CoQ10 and placebo with regard to CRP [MD = -0.21, 95% CI (-0.60 to 0.17 mg/L, I2 = 21%] and IL-6 [MD = -0.89, 95% CI (-1.95 to 0.16 pg/ml, I2 = 84%].CoQ10 supplementation may partly improve the process of inflammatory state. The effects of CoQ10 on inflammation should be further investigated by conducting larger sample size and well-defined trials of long enough duration.

  18. Genetics Home Reference: primary coenzyme Q10 deficiency

    Science.gov (United States)

    ... mutations have occurred in the COQ2 , COQ4 , COQ6 , COQ8A , and COQ8B genes. Smaller numbers of mutations in other COQ genes have also been found ... primary coenzyme Q10 deficiency ... Related Information What is a gene? What is a gene mutation and how do mutations occur? How can gene ...

  19. Global risk of pharmaceutical contamination from highly populated developing countries.

    Science.gov (United States)

    Rehman, Muhammad Saif Ur; Rashid, Naim; Ashfaq, Muhammad; Saif, Ameena; Ahmad, Nasir; Han, Jong-In

    2015-11-01

    Global pharmaceutical industry has relocated from the west to Asian countries to ensure competitive advantage. This industrial relocation has posed serious threats to the environment. The present study was carried out to assess the possible pharmaceutical contamination in the environment of emerging pharmaceutical manufacturing countries (Bangladesh, China, India and Pakistan). Although these countries have made tremendous progress in the pharmaceutical sector but most of their industrial units discharge wastewater into domestic sewage network without any treatment. The application of untreated wastewater (industrial and domestic) and biosolids (sewage sludge and manure) in agriculture causes the contamination of surface water, soil, groundwater, and the entire food web with pharmaceutical compounds (PCs), their metabolites and transformed products (TPs), and multidrug resistant microbes. This pharmaceutical contamination in Asian countries poses global risks via product export and international traveling. Several prospective research hypotheses including the development of new analytical methods to monitor these PCs/TPs and their metabolites, highly resistant microbial strains, and mixture toxicity as a consequence of pharmaceutical contamination in these emerging pharmaceutical exporters have also been proposed based on the available literature. Copyright © 2013 Elsevier Ltd. All rights reserved.

  20. Coenzyme Q10 and alpha-tocopherol protect against amitriptyline toxicity

    International Nuclear Information System (INIS)

    Cordero, Mario D.; Moreno-Fernandez, Ana Maria; Gomez-Skarmeta, Jose Luis; Miguel, Manuel de; Garrido-Maraver, Juan; Oropesa-Avila, Manuel; Rodriguez-Hernandez, Angeles; Navas, Placido; Sanchez-Alcazar, Jose Antonio

    2009-01-01

    Since amitriptyline is a very frequently prescribed antidepressant drug, it is not surprising that amitriptyline toxicity is relatively common. Amitriptyline toxic systemic effects include cardiovascular, autonomous nervous, and central nervous systems. To understand the mechanisms of amitriptyline toxicity we studied the cytotoxic effects of amitriptyline treatment on cultured primary human fibroblasts and zebrafish embryos, and the protective role of coenzyme Q 10 and alpha-tocopherol, two membrane antioxidants. We found that amitriptyline treatment induced oxidative stress and mitochondrial dysfunction in primary human fibroblasts. Mitochondrial dysfunction in amitriptyline treatment was characterized by reduced expression levels of mitochondrial proteins and coenzyme Q 10 , decreased NADH:cytochrome c reductase activity, and a drop in mitochondrial membrane potential. Moreover, and as a consequence of these toxic effects, amitriptyline treatment induced a significant increase in apoptotic cell death activating mitochondrial permeability transition. Coenzyme Q 10 and alpha-tocopherol supplementation attenuated ROS production, lipid peroxidation, mitochondrial dysfunction, and cell death, suggesting that oxidative stress affecting cell membrane components is involved in amitriptyline cytotoxicity. Furthermore, amitriptyline-dependent toxicity and antioxidant protection were also evaluated in zebrafish embryos, a well established vertebrate model to study developmental toxicity. Amitriptyline significantly increased embryonic cell death and apoptosis rate, and both antioxidants provided a significant protection against amitriptyline embryotoxicity

  1. Distal trisomy 10q syndrome, report of a patient with duplicated q24.31 – qter, autism spectrum disorder and unusual features

    Science.gov (United States)

    Al-Sarraj, Yasser; Al-Khair, Hakam Abu; Taha, Rowaida Ziad; Khattab, Namat; El Sayed, Zakaria H; Elhusein, Bushra; El-Shanti, Hatem

    2014-01-01

    Key Clinical Message We report on a patient with distal trisomy 10q syndrome presenting with a few previously undescribed physical features, as well as, autism spectrum disorder (ASD). We recommend that patients with distal trisomy 10q syndrome should have a behavioral evaluation for ASD for the early institution of therapy. PMID:25614812

  2. Is Co Q10 really valuable in shielding statin induced myopathy-an exploration

    International Nuclear Information System (INIS)

    Noor, M.; Waheed, A.; Muhammad, I; Bakhtiar, S.

    2016-01-01

    Objective: This study was designed to scrutinize the shielding effects of Co enzyme Q10 (Co Q10) supplementation in statin associated muscular adverse effects in rabbits. Study Design: Randomized controlled trial. Place and Duration of Study: Pharmacology dept Army Medical College Rawalpindi from Jan 2012 to Jun 2012. Material and Methods: Twenty two healthy rabbits were taken and divided into four equal groups randomly with six in each batch. The two groups (G1 and G2) were given toxic doses of simvastatin (60mg/kg/day) with and without Co Q10 (5mg/kg/day) orally for 14 days and rest of two groups (G3 and G4) were kept on therapeutic doses (1mg/kg/day) of simvastatin with and without Co Q10 (5mg/kg/day) orally for 90 days. Blood samples were drawn and serum creatinine kinase (CK) and lactate dehydrogenase (LDH) were assessed before and after the drug therapy. Histopathological examination was done to observe the inflammatory changes under light microscope. The results were analyzed by applying paired 't' test, independent 't' test and ANOVA test for biochemical markers and 'Chi-Square test' for histopathological findings. The p-value < 0.05 was considered significant. Results: The biochemical markers went up sharply (G1. CK=28899.5 +- 874.09 IU/L and LDH = 4694.33 +- 352 IU/L) and (G2. CK = 29191.33 +- 3019.79 IU/L and LDH = 4334.83 +- 143.44 IU/L) as compared to baseline values. They were given toxic doses of simvastatin with and without Co Q10. Histopathological examination of muscular tissue also revealed gross inflammatory changes in these groups. However histopathological examination of groups who were given therapeutic doses of simvastatin with and without Co Q10 for 90 days showed mild to moderate inflammatory changes but serum CK and LDH remained in the normal ranges in these groups. Conclusion: Our results suggest that Co Q10 supplementation could not produce any beneficial effects on the statin induced muscular adverse

  3. Global health: the ethical responsibility of the pharmaceutical industry.

    Science.gov (United States)

    Lassen, Lars Christian; Thomsen, Mads Krogsgaard

    2007-02-01

    Health as a global issue concerns all and clearly manifests global inequality. All stakeholders of the healthcare systems and disease treatment--including the pharmaceutical industry--have an ethical obligation to contribute to promoting global health. At Novo Nordisk we primarily focus on providing our contribution to global health through defeating diabetes. At the same time we stand by being a private company required to deliver a financial profit, which is why we must create positive results on the financial, the environmental and the social bottom lines. In this article we attempt to provide a brief overview of some of the initiatives that we think business companies can take--and therefore are also obliged to in promoting global health. Further, we have pointed out a number of dilemmas within research and development as well as business ethics that all companies face when they convert the ethical principles to daily practice globally.

  4. PSE in Pharmaceutical Process Development

    DEFF Research Database (Denmark)

    Gernaey, Krist; Cervera Padrell, Albert Emili; Woodley, John

    2011-01-01

    The pharmaceutical industry is under growing pressure to increase efficiency, both in production and in process development. This paper will discuss the use of Process Systems Engineering (PSE) methods in pharmaceutical process development, and searches for answers to questions such as: Which PSE...

  5. Open Data for Research and Strategic Monitoring in the Pharmaceutical and Biotech Industry

    Directory of Open Access Journals (Sweden)

    Baldissera Giovani

    2017-04-01

    Full Text Available Open data is considered the new oil. As oil can be used to produce fertilisers, pesticides, lubricants, plastics and many other derivatives, so data is considered the commodity to use and re-use to create value. The number of initiatives supporting free access to data has increased in the last years and open data is becoming the norm in the public sector; the approach empowers stakeholders and nurtures the economy. Even if at early stage, private companies also are adapting to the open data market. A survey was conducted to which thirteen companies of different size (from micro enterprises to world-leading pharmas in the pharmaceutical and biotech sector and representing four business models archetypes of companies exploiting open data (aggregators, developers, enrichers and enablers participated. The information collected provides a snapshot of the use of open data by the pharmaceutical and biotech industry in 2015–2016. The companies interviewed use open data to complement proprietary data for research purposes, to implement licensing-in/licensing-out strategies, to map partnerships and connections among players or to identify key expertise and hire staff. Pharmaceutical and biotech companies have made of the protection of knowledge a dogma at the foundation of their business models, but using and contributing to the open data movement may change their approach to intellectual property and innovation.

  6. Pharmaceutical contamination in residential, industrial, and agricultural waste streams: risk to aqueous environments in Taiwan.

    Science.gov (United States)

    Lin, Angela Yu-Chen; Yu, Tsung-Hsien; Lin, Cheng-Fang

    2008-12-01

    This is a comprehensive study of the occurrence of antibiotics, hormones and other pharmaceuticals in water sites that have major potential for downstream environmental contamination. These include residential (hospitals, sewage treatment plants, and regional discharges), industrial (pharmaceutical production facilities), and agricultural (animal husbandries and aquacultures) waste streams. We assayed 23 Taiwanese water sites for 97 targeted compounds, of which a significant number were detected and quantified. The most frequently detected compounds were sulfamethoxazole, caffeine, acetaminophen, and ibuprofen, followed closely by cephalexin, ofloxacin, and diclofenac, which were detected in >91% of samples and found to have median (maximum) concentrations of 0.2 (5.8), 0.39 (24.0), 0.02 (100.4), 0.41 (14.5), 0.15 (31.4), 0.14 (13.6) and 0.083 (29.8) microg/L, respectively. Lincomycin and acetaminophen had high measured concentrations (>100 microg/L), and 35 other pharmaceuticals occurred at the microg/L level. These incidence and concentration results correlate well with published data for other worldwide locations, as well as with Taiwanese medication usage data, suggesting a human contamination source. Many pharmaceuticals also occurred at levels exceeding predicted no-effect concentrations (PNEC), warranting further investigation of their occurrence and fate in receiving waters, as well as the overall risks they pose for local ecosystems and human residents. The information provided here will also be useful for development of strategies for regulation and remediation.

  7. Protection of dichlorvos induced oxidative stress and nigrostriatal neuronal death by chronic Coenzyme Q10 pretreatment

    International Nuclear Information System (INIS)

    Binukumar, BK; Gupta, Nidhi; Bal, Amanjit; Gill, Kiran Dip

    2011-01-01

    Numerous epidemiological studies have shown an association between pesticide exposure and increased risk of developing Parkinson's diseases. Oxidative stress generated as a result of mitochondrial dysfunction has been implicated as an important factor in the etiology of Parkinson's disease. Previously, we reported that chronic dichlorvos exposure causes mitochondrial impairments and nigrostriatal neuronal death in rats. The present study was designed to test whether Coenzyme Q 10 (CoQ 10 ) administration has any neuroprotective effect against dichlorvos mediated nigrostriatal neuronal death, α-synuclein aggregation, and motor dysfunction. Male albino rats were administered dichlorvos by subcutaneous injection at a dose of 2.5 mg/kg body weight over a period of 12 weeks. Results obtained there after showed that dichlorvos exposure leads to enhanced mitochondrial ROS production, α-synuclein aggregation, decreased dopamine and its metabolite levels resulting in nigrostriatal neurodegeneration. Pretreatment by Coenzyme Q 10 (4.5 mg/kg ip for 12 weeks) to dichlorvos treated animals significantly attenuated the extent of nigrostriatal neuronal damage, in terms of decreased ROS production, increased dopamine and its metabolite levels, and restoration of motor dysfunction when compared to dichlorvos treated animals. Thus, the present study shows that Coenzyme Q 10 administration may attenuate dichlorvos induced nigrostriatal neurodegeneration, α-synuclein aggregation and motor dysfunction by virtue of its antioxidant action. - Highlights: → CoQ 10 administration attenuates dichlorvos induced nigrostriatal neurodegenaration. → CoQ 10 pre treatment leads to preservation of TH-IR neurons. → CoQ 10 may decrease oxidative damage and α-synuclin aggregation. → CoQ 10 treatment enhances motor function and protects rats from catalepsy.

  8. On radiation treatment of pharmaceutical products

    International Nuclear Information System (INIS)

    Zukov, V.; Mende, V.

    1976-01-01

    The progress made in the GDR over the past decade in the field of radiosterilization of products of the medical industry, has naturally raised the question of radiosterilization in pharmaceutics. However, because of the diversity and complicated nature of pharmaceutical products and, consequently, longer periods of time required for preliminary studies, their radiosterilization has not yet been applied on an industrial scale, in contrast to the situation in the medical industry. The studies carried out so far have been mainly concerned with ascertaining the permissibility and effectiveness of radiosterilization of individual products under particular conditions rather than with laying down a broad theoretical basis. Accordingly, the present paper does not describe results of special studies but presents a brief rewiev of some studies on radiation treatment of pharmaceutical products undertaken in the GDR. (author)

  9. Improvement of Coenzyme Q10 Production: Mutagenesis Induced by High Hydrostatic Pressure Treatment and Optimization of Fermentation Conditions

    Directory of Open Access Journals (Sweden)

    Yahong Yuan

    2012-01-01

    Full Text Available Coenzyme Q10 (CoQ10, ubiquinone, a potent antioxidative dietary supplement, was produced by submerged fermentation using Agrobacterium tumefaciens instead of chemical synthesis or solvent extraction. Agrobacterium tumefaciens 1.2554 was subjected to mutagenesis using a series of treatments including high hydrostatic pressure (HHP treatment, UV irradiation, and diethyl sulfate (DES treatment to obtain mutant strains showing higher CoQ10 production than wild-type strains. A mutant strain PK38 with four genetic markers was isolated: the specific CoQ10 content of the mutant strain increased by 52.83% compared with the original strain. Effects of carbon and nitrogen sources on CoQ10 production with PK38 were studied. Sucrose at concentration of 30 g/l was tested as the best carbon source, and yeast extract at concentration of 30 g/l supplemented with 10 g/l of ammonium sulfate was identified to be the most favorable for CoQ10 production using PK38. Fed-batch culture strategy was then used for increasing production of CoQ10 in 5-l fermentor. Using the exponential feeding fed-batch culture of sucrose, cell growth and CoQ10 formation were significantly improved. With this strategy, the final cell biomass, CoQ10 production, and specific CoQ10 production increased by 126.11, 173.12, and 22.76%, respectively, compared to those of batch culture.

  10. Examining intentions to use CoQ10 amongst breast cancer patients.

    Science.gov (United States)

    Hill, Gina Jarman; Shriver, Brent J; Arnett, Dennis B

    2006-01-01

    To determine factors that influence breast cancer patients' intentions to supplement with CoQ10. A survey based upon the expanded rational expectations intentions model was completed by breast cancer outpatients (N=160). A significantly positive relationship existed between referent other (the influence specific people have in terms of an individual's behavior) and subjective norm (subject's perception of how people view a behavior). Beliefs, referent other, attitude, and subjective norm did have a significant effect on intention to use CoQ10. Health practitioners may address supplementation with breast cancer patients with a better understanding of what factors impact supplement use.

  11. Novel recessive mutations in COQ4 cause severe infantile cardiomyopathy and encephalopathy associated with CoQ10 deficiency

    Directory of Open Access Journals (Sweden)

    Neal Sondheimer

    2017-09-01

    Full Text Available Coenzyme Q10 (CoQ10 or ubiquinone is one of the two electron carriers in the mitochondrial respiratory chain which has an essential role in the process of oxidative phosphorylation. Defects in CoQ10 synthesis are usually associated with the impaired function of CoQ10–dependent complexes I, II and III. The recessively transmitted CoQ10 deficiency has been associated with a number of phenotypically and genetically heterogeneous groups of disorders manifesting at variable age of onset. The infantile, multisystemic presentation is usually caused by mutations in genes directly involved in CoQ10 biosynthesis. To date, mutations in COQ1 (PDSS1 and PDSS2, COQ2, COQ4, COQ6, COQ7, COQ8A/ADCK3, COQ8B/ADCK4, and COQ9 genes have been identified in patients with primary form of CoQ10 deficiency. Here we report novel mutations in the COQ4 gene, which were identified in an infant with profound mitochondrial disease presenting with perinatal seizures, hypertrophic cardiomyopathy and severe muscle CoQ10 deficiency.

  12. Novel recessive mutations in COQ4 cause severe infantile cardiomyopathy and encephalopathy associated with CoQ10 deficiency.

    Science.gov (United States)

    Sondheimer, Neal; Hewson, Stacy; Cameron, Jessie M; Somers, Gino R; Broadbent, Jane Dunning; Ziosi, Marcello; Quinzii, Catarina Maria; Naini, Ali B

    2017-09-01

    Coenzyme Q 10 (CoQ 10 ) or ubiquinone is one of the two electron carriers in the mitochondrial respiratory chain which has an essential role in the process of oxidative phosphorylation. Defects in CoQ 10 synthesis are usually associated with the impaired function of CoQ 10 -dependent complexes I, II and III. The recessively transmitted CoQ 10 deficiency has been associated with a number of phenotypically and genetically heterogeneous groups of disorders manifesting at variable age of onset. The infantile, multisystemic presentation is usually caused by mutations in genes directly involved in CoQ 10 biosynthesis. To date, mutations in COQ1 ( PDSS1 and PDSS2 ), COQ2 , COQ4 , COQ6 , COQ7 , COQ8A / ADCK3 , COQ8B/ADCK4 , and COQ9 genes have been identified in patients with primary form of CoQ 10 deficiency. Here we report novel mutations in the COQ4 gene, which were identified in an infant with profound mitochondrial disease presenting with perinatal seizures, hypertrophic cardiomyopathy and severe muscle CoQ 10 deficiency.

  13. Occurrence and removal of antibiotics, hormones and several other pharmaceuticals in wastewater treatment plants of the largest industrial city of Korea.

    Science.gov (United States)

    Behera, Shishir Kumar; Kim, Hyeong Woo; Oh, Jeong-Eun; Park, Hung-Suck

    2011-09-15

    Occurrence and removal efficiencies of 20 pharmaceuticals and personal care products (PPCPs) including antibiotics, hormones, and several other miscellaneous pharmaceuticals (analgesics, antiepileptics, antilipidemics, antihypertensives, antiseptics, and stimulants) were investigated in five wastewater treatment plants (WWTPs) of Ulsan, the largest industrial city of Korea. The compounds were extracted from wastewater samples by solid-phase extraction (SPE) and analyzed by High-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). The results showed that acetaminophen, atenolol and lincomycin were the main individual pollutants usually found in concentrations over 10 μg/L in the sewage influent. In the WWTPs, the concentrations of analgesic acetaminophen, stimulant caffeine, hormones estriol and estradiol decreased by over 99%. On the contrary, the antibiotic sulfamethazine, the antihypertensive metoprolol, and the antiepileptic carbamazepine exhibited removal efficiencies below 30%. Particularly, removal of antibiotics was observed to vary between -11.2 and 69%. In the primary treatment (physico-chemical processes), the removal of pharmaceuticals was insignificant (up to 28%) and removal of majority of the pharmaceuticals occurred during the secondary treatment (biological processes). The compounds lincomycin, carbamazepine, atenolol, metoprolol, and triclosan showed better removal in WWTPs employing modified activated sludge process with co-existence of anoxic-oxic condition. Further investigation into the design and operational aspects of the biological processes is warranted for the efficient removal of PPCPs, particularly antibiotics, to secure healthy water resource in the receiving downstream, thereby ensuring a sustainable water cycle management. Copyright © 2011. Published by Elsevier B.V.

  14. Novel recessive mutations in COQ4 cause severe infantile cardiomyopathy and encephalopathy associated with CoQ10 deficiency

    OpenAIRE

    Sondheimer, Neal; Hewson, Stacy; Cameron, Jessie M.; Somers, Gino R.; Broadbent, Jane Dunning; Ziosi, Marcello; Quinzii, Catarina Maria; Naini, Ali B.

    2017-01-01

    Coenzyme Q10 (CoQ10) or ubiquinone is one of the two electron carriers in the mitochondrial respiratory chain which has an essential role in the process of oxidative phosphorylation. Defects in CoQ10 synthesis are usually associated with the impaired function of CoQ10–dependent complexes I, II and III. The recessively transmitted CoQ10 deficiency has been associated with a number of phenotypically and genetically heterogeneous groups of disorders manifesting at variable age of onset. The infa...

  15. Pharmaceutical marketing research and the prescribing physician.

    Science.gov (United States)

    Greene, Jeremy A

    2007-05-15

    Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue.

  16. Self-reported adherence and biomarker levels of CoQ10 and alpha-tocopherol

    Directory of Open Access Journals (Sweden)

    Vitolins MZ

    2018-04-01

    Full Text Available Mara Z Vitolins,1 L Douglas Case,1 Stephen R Rapp,2 Mark O Lively,3 Edward G Shaw,4 Michelle J Naughton,5 Jeffrey Giguere,6 Glenn J Lesser7 1Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA; 2Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA; 3Department of Biochemistry, Wake Forest School of Medicine, Winston-Salem, NC, USA; 4Department of Internal Medicine-Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA; 5Department of Internal Medicine, The Ohio State University, Columbus, OH, USA; 6Greenville Community Oncology Research Program of the Carolinas, Greenville, SC, USA; 7Department of Internal Medicine-Hematology and Oncology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, USA Purpose: Women with breast cancer were randomized to receive coenzyme Q10 (CoQ10 plus Vitamin E or placebo in a clinical trial. The objective of this evaluation is to examine the association between participant self-reported adherence to the study supplements and changes in plasma biomarker levels.Patients and methods: Correlation coefficients quantified the association between changes in alpha-tocopherol and CoQ10 levels and the association between self-reported adherence and changes in biomarkers. Participants were categorized by self-reported adherence; Kruskal–Wallis tests compared changes in alpha-tocopherol and CoQ10 levels between self-reported adherence groups.Results: Women (N=155 provided baseline and post-treatment biomarkers; 147 completed at least one diary. While changes in alpha-tocopherol and CoQ10 levels were moderately correlated, correlations ranged from 0.40 to 0.48, association between self-reported adherence and plasma alpha-tocopherol or CoQ10 levels was weak; correlations ranged from 0.10 to 0.29 at weeks 8, 16, and 24. Some participants with high self-reported adherence actually

  17. Pharmaceutical cocrystals: an overview.

    Science.gov (United States)

    Qiao, Ning; Li, Mingzhong; Schlindwein, Walkiria; Malek, Nazneen; Davies, Angela; Trappitt, Gary

    2011-10-31

    Pharmaceutical cocrystals are emerging as a new class of solid drugs with improved physicochemical properties, which has attracted increased interests from both industrial and academic researchers. In this paper a brief and systematic overview of pharmaceutical cocrystals is provided, with particular focus on cocrystal design strategies, formation methods, physicochemical property studies, characterisation techniques, and recent theoretical developments in cocrystal screening and mechanisms of cocrystal formations. Examples of pharmaceutical cocrystals are also summarised in this paper. Copyright © 2011 Elsevier B.V. All rights reserved.

  18. Evaluation of Co-Q10 anti-gingivitis effect on plaque induced gingivitis: A randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Anirban Chatterjee

    2012-01-01

    Full Text Available Background: Deficiency of Co-Q10 has been found to be responsible for periodontal destruction; therefore, this study was undertaken to evaluate the anti-gingivitis effect of Co-Q10 on plaque induced gingivitis. Materials and Methods: Thirty subjects with plaque induced gingivitis were enrolled in a split mouth randomized controlled trial. For each subject, scaling was randomly performed for any two quadrants, followed by the topical application of Co-Q10 randomly in a previously scaled and as an unscaled quadrant for a period of 28 days. Four treatment options were planned: option A: scaling only; option B: Co-Q10 along with scaling; option C: Co-Q10. Results: Marked reduction in gingival, bleeding, and plaque scores were recorded at the sites where C0-Q10 was applied. Mean±S.D of aforementioned periodontal parameters at 28th day showed significant reduction for option A, B, and C when compared with baseline. Conclusion: Promising results were obtained after the solitary application of Co-Q10 as well as when it was used as an adjunct to scaling and root planing for treatment of plaque induced gingivitis.

  19. Coenzyme Q10 and soyphosphatidylcholine in EK extender on preservation of Rhode Island Red poultry semen

    Directory of Open Access Journals (Sweden)

    Amit Kumar Nath

    2015-06-01

    Full Text Available The objective of this study was to evaluate the efficacy of EK extender alone or incorporation with CoenzymeQ10 (CoQ10 and/or soyphosphatidylcholine (SPC in poultry semen and their effects on seminal traits during temporal storage at 4⁰C for different time intervals (12 h, 24 h, and 36 h. Heterospermic pooled semen samples diluted (1:4 with EK, EK + SPC, EK+ CoQ10 and EK + SPC + CoQ10 extenders separately, preserved and different spermiogram were assessed. Various seminal traits within the same extender differ significantly (p<0.05 among different groups and with different time intervals of storage. CoQ10 and SPC in the EK extender exhibited favorable synergistic effect on sperm quality and were able to protect the male gametes against cold-stress up to 36h at 4⁰C. In this study, we concluded that incorporation of SPC and CoQ10 together in EK extender possess novel potentiality to maintain seminal quality during liquid storage of poultry semen at 4⁰C and for their safe transportation and further use for Artificial Reproductive technologies (ARTs.

  20. A prospective before-and-after trial of an educational intervention about pharmaceutical marketing.

    Science.gov (United States)

    Agrawal, Sacha; Saluja, Inderpal; Kaczorowski, Janusz

    2004-11-01

    There is increasing evidence that physicians may be compromised by their interactions with the pharmaceutical industry. The authors aimed to develop and determine the effect of an educational intervention to inform family medicine residents about pharmaceutical marketing. Confidential, self-administered questionnaires were administered to family medicine residents at McMaster University, Hamilton, Canada, immediately before and after a two-part, 2.5-hour educational intervention. The curriculum consisted of (1) a faculty-led debate and discussion of a systematic review of physician-pharmaceutical industry interactions, and (2) an interactive workshop that included a presentation highlighting key empirical findings, a video illustrating techniques to optimize pharmaceutical sales representatives' visits, and small- and large-group problem-based discussions. Residents were asked about their attitudes toward five marketing strategies: drug samples, industry-sponsored continuing medical education, one-on-one interactions with sales representatives, free meals, and gifts worth less than CAN $10. A total of 37 residents responded to both questionnaires. After the intervention residents had more cautious attitudes, rating marketing strategies on a five-point Likert scale as less ethically appropriate (-0.41, p marketing. Its long-term sustainability and effect on behavior remain unknown.

  1. Coenzyme Q10 Attenuates High Glucose-Induced Endothelial Progenitor Cell Dysfunction through AMP-Activated Protein Kinase Pathways

    Directory of Open Access Journals (Sweden)

    Hsiao-Ya Tsai

    2016-01-01

    Full Text Available Coenzyme Q10 (CoQ10, an antiapoptosis enzyme, is stored in the mitochondria of cells. We investigated whether CoQ10 can attenuate high glucose-induced endothelial progenitor cell (EPC apoptosis and clarified its mechanism. EPCs were incubated with normal glucose (5 mM or high glucose (25 mM enviroment for 3 days, followed by treatment with CoQ10 (10 μM for 24 hr. Cell proliferation, nitric oxide (NO production, and JC-1 assay were examined. The specific signal pathways of AMP-activated protein kinase (AMPK, eNOS/Akt, and heme oxygenase-1 (HO-1 were also assessed. High glucose reduced EPC functional activities, including proliferation and migration. Additionally, Akt/eNOS activity and NO production were downregulated in high glucose-stimulated EPCs. Administration of CoQ10 ameliorated high glucose-induced EPC apoptosis, including downregulation of caspase 3, upregulation of Bcl-2, and increase in mitochondrial membrane potential. Furthermore, treatment with CoQ10 reduced reactive oxygen species, enhanced eNOS/Akt activity, and increased HO-1 expression in high glucose-treated EPCs. These effects were negated by administration of AMPK inhibitor. Transplantation of CoQ10-treated EPCs under high glucose conditions into ischemic hindlimbs improved blood flow recovery. CoQ10 reduced high glucose-induced EPC apoptosis and dysfunction through upregulation of eNOS, HO-1 through the AMPK pathway. Our findings provide a potential treatment strategy targeting dysfunctional EPC in diabetic patients.

  2. Coenzyme Q10 Attenuates High Glucose-Induced Endothelial Progenitor Cell Dysfunction through AMP-Activated Protein Kinase Pathways

    Science.gov (United States)

    Tsai, Hsiao-Ya; Lin, Chih-Pei; Huang, Po-Hsun; Li, Szu-Yuan; Chen, Jia-Shiong; Lin, Feng-Yen; Chen, Jaw-Wen; Lin, Shing-Jong

    2016-01-01

    Coenzyme Q10 (CoQ10), an antiapoptosis enzyme, is stored in the mitochondria of cells. We investigated whether CoQ10 can attenuate high glucose-induced endothelial progenitor cell (EPC) apoptosis and clarified its mechanism. EPCs were incubated with normal glucose (5 mM) or high glucose (25 mM) enviroment for 3 days, followed by treatment with CoQ10 (10 μM) for 24 hr. Cell proliferation, nitric oxide (NO) production, and JC-1 assay were examined. The specific signal pathways of AMP-activated protein kinase (AMPK), eNOS/Akt, and heme oxygenase-1 (HO-1) were also assessed. High glucose reduced EPC functional activities, including proliferation and migration. Additionally, Akt/eNOS activity and NO production were downregulated in high glucose-stimulated EPCs. Administration of CoQ10 ameliorated high glucose-induced EPC apoptosis, including downregulation of caspase 3, upregulation of Bcl-2, and increase in mitochondrial membrane potential. Furthermore, treatment with CoQ10 reduced reactive oxygen species, enhanced eNOS/Akt activity, and increased HO-1 expression in high glucose-treated EPCs. These effects were negated by administration of AMPK inhibitor. Transplantation of CoQ10-treated EPCs under high glucose conditions into ischemic hindlimbs improved blood flow recovery. CoQ10 reduced high glucose-induced EPC apoptosis and dysfunction through upregulation of eNOS, HO-1 through the AMPK pathway. Our findings provide a potential treatment strategy targeting dysfunctional EPC in diabetic patients. PMID:26682233

  3. Civic Engagement as Risk Management and Public Relations: What the Pharmaceutical Industry Can Teach Us about Service-Learning

    Science.gov (United States)

    Scott, J. Blake

    2009-01-01

    The pharmaceutical industry's corporate responsibility reports illustrate how the liberal rhetoric of civic engagement can be reappropriated to serve the market-driven aims of risk management and public relations. Tracing the ideologic linkage of corporate responsibility and service-learning versions of civic engagement, and contextualizing…

  4. Experimental cross sections for two-electron capture into nitrogen autoionising states in Nsup(q+) (q=6,7) on He and H2 collisions at 10.5q keV

    International Nuclear Information System (INIS)

    Bordenave-Montesquieu, A.; Benoit-Cattin, P.; Gleizes, A.; Marrakchi, A.I.

    1985-01-01

    Singly differential cross sections for two-electron capture into autoionising states (nl,n'l') with n=2,3,4 and n'>=n in Nsup(q+) (q=6,7) on He and H 2 collisions have been measured at 10,5q ke V collision energy and an observation angle thetasub(lab)=11.6 0 . Total cross sections are estimated assuming isotropic angular distributions. (orig.)

  5. Efficient Lewis Acid Ionic Liquid-Catalyzed Synthesis of the Key Intermediate of Coenzyme Q10 under Microwave Irradiation

    Directory of Open Access Journals (Sweden)

    Thomas Efferth

    2010-12-01

    Full Text Available An efficient synthesis of a valuable intermediate of coenzyme Q10 by microwave-assisted Lewis acidic ionic liquid (IL-catalyzed Friedel-Crafts alkylation is reported. The acidity of six [Etpy]BF4-based ionic liquids was characterized by means of the FT-IR technique using acetonitrile as a molecular probe. The catalytic activities of these ionic liquids were correlated with their Lewis acidity. With increasing Lewis acid strength of the ionic liquids, their catalytic activity in the Friedel-Crafts reaction increased, except for [Etpy]BF4-AlCl3. The effects of the reaction system, the molar fraction of Lewis acid in the Lewis acid ILs and heating techniques were also investigated. Among the six Lewis acid ionic liquids tested [Etpy]BF4-ZnCl2 showed the best catalytic activity, with a yield of 89% after a very short reaction time (150 seconds. This procedure has the advantages of higher efficiency, better reusability of ILs, energy conservation and eco-friendliness. The method has practical value for preparation of CoQ10 on an industrial scale.

  6. Combined aerobic and physicochemical treatment of pharmaceutical industry sludge

    International Nuclear Information System (INIS)

    Asia, Q.I.; Ademoroti, A.M.C.

    2005-01-01

    Composite samples of sludge obtained from a pharmaceutical factory were analysed for their pollution characteristics. The samples were then treated by integrated aerobic biological and physicochemical methods. The analysis revealed that the BOD and COD of the sludge liquor were high, as well as were the levels of solids concentration, nitrogen, phosphorus and bacterial count. These showed that sludge from this industry had a high pollution potential, and therefore needed treatment before disposal or reuse in other applications. Percentage solids reduction achieved were in the range of 26.1 to 29% of total soluble solids, 26.1 to 33% of suspended solids, and 43 to 52% of volatile solids, BOD and COD reductions were in the range of 96.1 to 98.2% and 96.8 to 98.4% respectively. Ammonia nitrogen reductions in this sludge were about 85.2 to 93.3%. Total nitrogen and phosphorus were also found to be appreciably reduced by the combined aerobic and physicochemical treatment methods. (author)

  7. Effects of coenzyme Q10 on statin-induced myopathy: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Banach, Maciej; Serban, Corina; Sahebkar, Amirhossein; Ursoniu, Sorin; Rysz, Jacek; Muntner, Paul; Toth, Peter P; Jones, Steven R; Rizzo, Manfredi; Glasser, Stephen P; Lip, Gregory Y H; Dragan, Simona; Mikhailidis, Dimitri P

    2015-01-01

    To evaluate the efficacy of coenzyme Q10 (CoQ10) supplementation on statin-induced myopathy. We searched the MEDLINE, Cochrane Library, Scopus, and EMBASE databases (November 1, 1987, to May 1, 2014) to identify randomized controlled trials investigating the impact of CoQ10 on muscle pain and plasma creatine kinase (CK) activity as 2 measures of statin-induced myalgia. Two independent reviewers extracted data on study characteristics, methods, and outcomes. We included 6 studies with 302 patients receiving statin therapy: 5 studies with 226 participants evaluated the effect of CoQ10 supplementation on plasma CK activity, and 5 studies (4 used in the CK analysis and 1 other study) with 253 participants were included to assess the effect of CoQ10 supplementation on muscle pain. Compared with the control group, plasma CK activity was increased after CoQ10 supplementation, but this change was not significant (mean difference, 11.69 U/L [to convert to μkat/L, multiply by 0.0167]; 95% CI, -14.25 to 37.63 U/L; P=.38). Likewise, CoQ10 supplementation had no significant effect on muscle pain despite a trend toward a decrease (standardized mean difference, -0.53; 95% CI, -1.33 to 0.28; P=.20). No dose-effect association between changes in plasma CK activity (slope, -0.001; 95% CI, -0.004 to 0.001; P=.33) or in the indices of muscle pain (slope, 0.002; 95% CI, -0.005 to 0.010; P=.67) and administered doses of CoQ10 were observed. The results of this meta-analysis of available randomized controlled trials do not suggest any significant benefit of CoQ10 supplementation in improving statin-induced myopathy. Larger, well-designed trials are necessary to confirm the findings from this meta-analysis. Copyright © 2015 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  8. A novel approach for inventory problem in the pharmaceutical supply chain.

    Science.gov (United States)

    Candan, Gökçe; Yazgan, Harun Reşit

    2016-02-24

    In pharmaceutical enterprises, keeping up with global market conditions is possible with properly selected supply chain management policies. Generally; demand-driven classical supply chain model is used in the pharmaceutical industry. In this study, a new mathematical model is developed to solve an inventory problem in the pharmaceutical supply chain. Unlike the studies in literature, the "shelf life and product transition times" constraints are considered, simultaneously, first time in the pharmaceutical production inventory problem. The problem is formulated as a mixed-integer linear programming (MILP) model with a hybrid time representation. The objective is to maximize total net profit. Effectiveness of the proposed model is illustrated considering a classical and a vendor managed inventory (VMI) supply chain on an experimental study. To show the effectiveness of the model, an experimental study is performed; which contains 2 different supply chain policy (Classical and VMI), 24 and 30 months planning horizon, 10 and 15 different cephalosporin products. Finally the mathematical model is compared to another model in literature and the results show that proposed model is superior. This study suggest a novel approach for solving pharmaceutical inventory problem. The developed model is maximizing total net profit while determining optimal production plan under shelf life and product transition constraints in the pharmaceutical industry. And we believe that the proposed model is much more closed to real life unlike the other studies in literature.

  9. Hepatoprotective effect of taurine and coenzyme Q10 and their ...

    African Journals Online (AJOL)

    stress in rats. Afaf Abbass Sayed ... Keywords: Taurine, Coenzyme Q10, Acrylamide, Oxidative stress, Biochemical profile, ... uses, AA formation in foods has its major routes through .... release of serum inflammatory markers and neutrophil ...

  10. Coenzyme Q10 Levels Are Decreased in the Cerebellum of Multiple-System Atrophy Patients.

    Directory of Open Access Journals (Sweden)

    Lucia V Schottlaender

    Full Text Available The objective of this study was to evaluate whether the levels of coenzyme Q10 (CoQ10 in brain tissue of multiple system atrophy (MSA patients differ from those in elderly controls and in patients with other neurodegenerative diseases.Flash frozen brain tissue of a series of 20 pathologically confirmed MSA patients [9 olivopontocerebellar atrophy (OPCA type, 6 striatonigral degeneration (SND type, and 5 mixed type] was used for this study. Elderly controls (n = 37 as well as idiopathic Parkinson's disease (n = 7, dementia with Lewy bodies (n = 20, corticobasal degeneration (n = 15 and cerebellar ataxia (n = 18 patients were used as comparison groups. CoQ10 was measured in cerebellar and frontal cortex tissue by high performance liquid chromatography.We detected a statistically significant decrease (by 3-5% in the level of CoQ10 in the cerebellum of MSA cases (P = 0.001, specifically in OPCA (P = 0.001 and mixed cases (P = 0.005, when compared to controls as well as to other neurodegenerative diseases [dementia with Lewy bodies (P<0.001, idiopathic Parkinson's disease (P<0.001, corticobasal degeneration (P<0.001, and cerebellar ataxia (P = 0.001].Our results suggest that a perturbation in the CoQ10 biosynthetic pathway is associated with the pathogenesis of MSA but the mechanism behind this finding remains to be elucidated.

  11. Oxidative Stress Correlates with Headache Symptoms in Fibromyalgia: Coenzyme Q10 Effect on Clinical Improvement

    Science.gov (United States)

    Cordero, Mario D.; Cano-García, Francisco Javier; Alcocer-Gómez, Elísabet; De Miguel, Manuel; Sánchez-Alcázar, José Antonio

    2012-01-01

    Background Fibromyalgia (FM) is a chronic pain syndrome with unknown etiology and a wide spectrum of symptoms such as allodynia, debilitating fatigue, joint stiffness and migraine. Recent studies have shown some evidences demonstrating that oxidative stress is associated to clinical symptoms in FM of fibromyalgia. We examined oxidative stress and bioenergetic status in blood mononuclear cells (BMCs) and its association to headache symptoms in FM patients. The effects of oral coenzyme Q10 (CoQ10) supplementation on biochemical markers and clinical improvement were also evaluated. Methods We studied 20 FM patients and 15 healthy controls. Clinical parameters were evaluated using the Fibromyalgia Impact Questionnaire (FIQ), visual analogues scales (VAS), and the Headache Impact Test (HIT-6). Oxidative stress was determined by measuring CoQ10, catalase and lipid peroxidation (LPO) levels in BMCs. Bioenergetic status was assessed by measuring ATP levels in BMCs. Results We found decreased CoQ10, catalase and ATP levels in BMCs from FM patients as compared to normal control (P<0.05 and P<0.001, respectively) We also found increased level of LPO in BMCs from FM patients as compared to normal control (P<0.001). Significant negative correlations between CoQ10 or catalase levels in BMCs and headache parameters were observed (r = −0.59, P<0.05; r = −0.68, P<0.05, respectively). Furthermore, LPO levels showed a significant positive correlation with HIT-6 (r = 0.33, P<0.05). Oral CoQ10 supplementation restored biochemical parameters and induced a significant improvement in clinical and headache symptoms (P<0.001). Discussion The results of this study suggest a role for mitochondrial dysfunction and oxidative stress in the headache symptoms associated with FM. CoQ10 supplementation should be examined in a larger placebo controlled trial as a possible treatment in FM. PMID:22532869

  12. Application of coenzyme Q10 for accelerating soft tissue wound healing after tooth extraction in rats.

    Science.gov (United States)

    Yoneda, Toshiki; Tomofuji, Takaaki; Kawabata, Yuya; Ekuni, Daisuke; Azuma, Tetsuji; Kataoka, Kota; Kunitomo, Muneyoshi; Morita, Manabu

    2014-12-10

    Accelerating wound healing after tooth extraction is beneficial in dental treatment. Application of antioxidants, such as reduced coenzyme Q10 (rCoQ10), may promote wound healing after tooth extraction. In this study, we examined the effects of topical application of rCoQ10 on wound healing after tooth extraction in rats. After maxillary first molars were extracted, male Fischer 344 rats (8 weeks old) (n = 27) received topical application of ointment containing 5% rCoQ10 (experimental group) or control ointment (control group) to the sockets for 3 or 8 days (n = 6-7/group). At 3 days after extraction, the experimental group showed higher collagen density and lower numbers of polymorphonuclear leukocytes in the upper part of socket, as compared to the control group (p healing in the soft tissue of the alveolar socket, but that rCoQ10 has a limited effect on bone remodeling in rats.

  13. Could the Pharmaceutical Industry Benefit from Full-Scale Adoption of Radio-Frequency Identification (RFID) Technology with New Regulations?

    Science.gov (United States)

    Coustasse, Alberto; Kimble, Craig A; Stanton, Robert B; Naylor, Mariah

    2016-01-01

    Healthcare regulators are directing attention to the pharmaceutical supply chain with the passage of the Drug Quality and Security Act (DQSA) and the Drug Supply Chain Security Act (DSCSA). Adoption of Radio-Frequency Identification (RFID) technology has the ability to improve compliance, reduce costs, and improve safety in the supply chain but its implementation has been limited; primarily because of hardware and tag costs. The purpose of this research study was to analyze the benefits to the pharmaceutical industry and healthcare system of the adoption of RFID technology as a result of newly implemented supply chain regulations. The methodology was a review following the steps of a systematic review with a total of 96 sources used. With the DSCSA, pharmaceutical companies must track and trace prescription drugs across the supply chain, and RFID can resolve many track-and-trace issues with manufacturer control of data. The practical implication of this study is that pharmaceutical companies must continue to have the potential to increase revenues, decrease associated costs, and increase compliance with new FDA regulations with RFID. Still, challenges related to regulatory statute wording, implementation of two-dimensional barcode technology, and the variety of interfaces within the pharmaceutical supply chain have delayed adoption and its full implementation.

  14. Additive enhancement of wound healing in diabetic mice by low level light and topical CoQ10

    Science.gov (United States)

    Mao, Zhigang; Wu, Jeffrey H.; Dong, Tingting; Wu, Mei X.

    2016-02-01

    Diabetes, a highly prevalent disease that affects 9.3% of Americans, often leads to severe complications and slow wound healing. Preclinical studies have suggested that low level light therapy (LLLT) can accelerate wound healing in diabetic subjects, but significant improvements must be made to overcome the absence of persuasive evidence for its clinical use. We demonstrate here that LLLT can be combined with topical Coenzyme Q10 (CoQ10) to heal wounds in diabetic mice significantly faster than LLLT alone, CoQ10 alone, or controls. LLLT followed by topical CoQ10 enhanced wound healing by 68~103% in diabetic mice in the first week and more than 24% in the second week compared with untreated controls. All wounds were fully healed in two weeks following the dual treatment, in contrast to only 50% wounds or a fewer being fully healed for single or sham treatment. The accelerated healing was corroborated by at least 50% higher hydroxyproline levels, and tripling cell proliferation rates in LLLT and CoQ10 treated wounds over controls. The beneficial effects on wound healing were probably attributed to additive enhancement of ATP production by LLLT and CoQ10 treatment. The combination of LLLT and topical CoQ10 is safe and convenient, and merits further clinical study.

  15. Additive enhancement of wound healing in diabetic mice by low level light and topical CoQ10.

    Science.gov (United States)

    Mao, Zhigang; Wu, Jeffrey H; Dong, Tingting; Wu, Mei X

    2016-02-02

    Diabetes, a highly prevalent disease that affects 9.3% of Americans, often leads to severe complications and slow wound healing. Preclinical studies have suggested that low level light therapy (LLLT) can accelerate wound healing in diabetic subjects, but significant improvements must be made to overcome the absence of persuasive evidence for its clinical use. We demonstrate here that LLLT can be combined with topical Coenzyme Q10 (CoQ10) to heal wounds in diabetic mice significantly faster than LLLT alone, CoQ10 alone, or controls. LLLT followed by topical CoQ10 enhanced wound healing by 68~103% in diabetic mice in the first week and more than 24% in the second week compared with untreated controls. All wounds were fully healed in two weeks following the dual treatment, in contrast to only 50% wounds or a fewer being fully healed for single or sham treatment. The accelerated healing was corroborated by at least 50% higher hydroxyproline levels, and tripling cell proliferation rates in LLLT and CoQ10 treated wounds over controls. The beneficial effects on wound healing were probably attributed to additive enhancement of ATP production by LLLT and CoQ10 treatment. The combination of LLLT and topical CoQ10 is safe and convenient, and merits further clinical study.

  16. Internationalization and technological leapfrogging in the pharmaceutical industry

    OpenAIRE

    Suma Athreye; Andrew Godley

    2009-01-01

    The pre-refereed author version of this article was published as a UNI-MERIT Working Paper under the title “Internationalising to create Firm Specific Advantages: Leapfrogging strategies of U.S. Pharmaceutical firms in the 1930s and 1940s & Indian Pharmaceutical firms in the 1990s and 2000s”. The paper can be downloaded from the UNU-MERIT website from the following link: http://arno.unimaas.nl/show.cgi?fid=12607. Internationalization is a useful strategy for gaining firm-specific technolog...

  17. Concentrations in beef and lamb of taurine, carnosine, coenzyme Q(10), and creatine.

    Science.gov (United States)

    Purchas, R W; Rutherfurd, S M; Pearce, P D; Vather, R; Wilkinson, B H P

    2004-03-01

    Levels of taurine, carnosine, coenzyme Q(10), and creatine were measured in beef liver and several muscles of beef and lamb and in cooked and uncooked meat. The amino acid taurine has numerous biological functions, the dipeptide carnosine is a buffer as well as an antioxidant, coenzyme Q(10) is also an antioxidant present within mitochondria, and creatine along with creatine phosphate is involved with energy metabolism in muscle. Large differences were shown for all compounds between beef cheek muscle (predominantly red fibres) and beef semitendinosus muscle (mainly white fibres), with cheek muscle containing 9.9 times as much taurine, and 3.2 times as much coenzyme Q(10), but only 65% as much creatine and 9% as much carnosine. Levels in lamb relative to beef semitendinosus muscles were higher for taurine but slightly lower for carnosine, coenzyme Q(10) and creatine. Values for all the compounds varied significantly between eight lamb muscles, possibly due in part to differences in the proportion of muscle fibre types. Slow cooking (90 min at 70 °C) of lamb longissimus and semimembranosus muscles led to significant reductions in the content of taurine, carnosine, and creatine (Plamb, but that these levels vary between muscles, between animals, and with cooking.

  18. Preclinical QSP Modeling in the Pharmaceutical Industry: An IQ Consortium Survey Examining the Current Landscape

    Science.gov (United States)

    Wu, Fan; Bansal, Loveleena; Bradshaw‐Pierce, Erica; Chan, Jason R.; Liederer, Bianca M.; Mettetal, Jerome T.; Schroeder, Patricia; Schuck, Edgar; Tsai, Alice; Xu, Christine; Chimalakonda, Anjaneya; Le, Kha; Penney, Mark; Topp, Brian; Yamada, Akihiro

    2018-01-01

    A cross‐industry survey was conducted to assess the landscape of preclinical quantitative systems pharmacology (QSP) modeling within pharmaceutical companies. This article presents the survey results, which provide insights on the current state of preclinical QSP modeling in addition to future opportunities. Our results call attention to the need for an aligned definition and consistent terminology around QSP, yet highlight the broad applicability and benefits preclinical QSP modeling is currently delivering. PMID:29349875

  19. Widening the debate about conflict of interest: addressing relationships between journalists and the pharmaceutical industry.

    Science.gov (United States)

    Lipworth, Wendy; Kerridge, Ian; Sweet, Melissa; Jordens, Christopher; Bonfiglioli, Catriona; Forsyth, Rowena

    2012-08-01

    The phone-hacking scandal that led to the closure of the News of the World newspaper in Britain has prompted international debate about media practices and regulation. It is timely to broaden the discussion about journalistic ethics and conduct to include consideration of the impact of media practices upon the population's health. Many commercial organisations cultivate relationships with journalists and news organisations with the aim of influencing the content of health-related news and information communicated through the media. Given the significant influence of the media on the health of individuals and populations, we should be alert to the potential impact of industry-journalist relationships on health care, health policy and public health. The approach taken by the medical profession to its interactions with the pharmaceutical industry provides a useful model for management of industry influence.

  20. New opportunities for biocatalysis: making pharmaceutical processes greener

    DEFF Research Database (Denmark)

    Woodley, John

    2008-01-01

    The pharmaceutical industry requires synthetic routes to be environmentally compatible as well as to fulfill the demands of process economics and product specification and to continually reduce development times. Biocatalysis has the potential to deliver 'greener' chemical syntheses, and in this ......The pharmaceutical industry requires synthetic routes to be environmentally compatible as well as to fulfill the demands of process economics and product specification and to continually reduce development times. Biocatalysis has the potential to deliver 'greener' chemical syntheses...... of biocatalysis for making pharmaceutical processes greener....

  1. Monitoring of trace metals and pharmaceuticals as anthropogenic and socio-economic indicators of urban and industrial impact on surface waters

    Science.gov (United States)

    Vystavna, Yuliya

    2014-05-01

    The research focuses on the monitoring of trace metals and pharmaceuticals as potential anthropogenic indicators of industrial and urban influences on surface water in poorly gauged transboundary Ukraine/Russia region. This study includes analysis of tracers use for the indication of water pollution events, including controlled and emerging discharges, and discussion of the detection method of these chemicals. The following criteria were proposed for the evaluation of indicators: specificity (physical chemical properties), variability (spatial and temporal) and practicality (capacity of the sampling and analytical techniques). The combination of grab and passive water sampling (i.e. DGT and POCIS) procedure was applied for the determination of dissolved and labile trace metals (Ag, Cd, Cr, Cu, Ni, Pb and Zn) and pharmaceuticals (carbamazepine, diazepam, paracetamol, caffeine, diclofenac and ketoprofen). Samples were analysed using ICP - MS (trace metals) and LC-MS/MS ESI +/- (pharmaceuticals). Our results demonstrate the distinctive spatial and temporal patterns of trace elements distribution along an urban watercourse. Accordingly, two general groups of trace metals have been discriminated: 'stable' (Cd and Cr) and 'time-varying' (Cu, Zn, Ni and Pb). The relationship Cd >> Cu > Ag > Cr ≥ Zn was proposed as an anthropogenic signature of the industrial and urban activities pressuring the environment from point sources (municipal wastewaters) and the group Pb - Ni was discussed as a relevant fingerprint of the economic activity (industry and transport) mainly from non-point sources (run-off, atmospheric depositions, etc.). Pharmaceuticals with contrasting hydro-chemical properties of molecules (water solubility, bioaccumulation, persistence during wastewater treatment processes) were discriminated on conservative, labile and with combined properties in order to provide information on wastewater treatment plant efficiency, punctual events (e.g. accidents on sewage

  2. 46 CFR 90.10-16 - Industrial vessel.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Industrial vessel. 90.10-16 Section 90.10-16 Shipping... PROVISIONS Definition of Terms Used in This Subchapter § 90.10-16 Industrial vessel. This term means every vessel which by reason of its special outfit, purpose, design, or function engages in certain industrial...

  3. Detection of foodborne pathogens by qPCR: A practical approach for food industry applications

    Directory of Open Access Journals (Sweden)

    María-José Chapela

    2015-12-01

    Full Text Available Microbiological analysis of food is an integrated part of microbial safety management in the food chain. Monitoring and controlling foodborne pathogens are traditionally carried out by conventional microbiological methods based on culture-dependent approaches in control laboratories and private companies. However, polymerase chain reaction (PCR has revolutionized microbiological analysis allowing detection of pathogenic microorganisms in food, without the necessity of classical isolation and identification. However, at present, PCR and quantitative polymerase chain reaction (qPCR are essential analytical tools for researchers working in the field of foodborne pathogens. This manuscript reviews recently described qPCR methods applied for foodborne bacteria detection, serving as economical, safe, and reliable alternatives for application in the food industry and control laboratories. Multiplex qPCR, which allows the simultaneous detection of more than one pathogen in one single reaction, saving considerable effort, time, and money, is emphasized in the article.

  4. The use of coenzyme Q0 as a template in the development of a molecularly imprinted polymer for the selective recognition of coenzyme Q10.

    Science.gov (United States)

    Contin, Mario; Flor, Sabrina; Martinefski, Manuela; Lucangioli, Silvia; Tripodi, Valeria

    2014-01-07

    In this work, a novel molecularly imprinted polymer (MIP) for use as a solid phase extraction sorbent was developed for the determination of coenzyme Q10 (CoQ10) in liver extract. CoQ10 is an essential cofactor in mitochondrial oxidative phosphorylation and a powerful antioxidant agent found in low concentrations in biological samples. This fact and its high hydrophobicity make the analysis of CoQ10 technically challenging. Accordingly, a MIP was synthesised using coenzyme Q0 as the template, methacrylic acid as the functional monomer, acetonitrile as the porogen, ethylene glycol dimethacrylate as the crosslinker and benzoyl peroxide as the initiator. Various parameters affecting the polymer preparation and extraction efficiency were evaluated. Morphological characterisation of the MIP and its proper comparison with C18 as a sorbent in solid phase extraction were performed. The optimal conditions for the molecularly imprinted solid phase extraction (MISPE) consisted of 400 μL of sample mixed with 30 mg of MIP and 600 μL of water to reach the optimum solution loading. The loading was followed by a washing step consisting of 1 mL of a 1-propanol solution (1-propanol:water, 30:70,v/v) and elution with 1 mL of 1-propanol. After clean-up, the CoQ10 in the samples was analysed by high performance liquid chromatography. The extraction recoveries were higher than 73.7% with good precision (3.6-8.3%). The limits of detection and quantification were 2.4 and 7.5 μg g(-1), respectively, and a linear range between 7.5 and 150 μg g(-1) of tissue was achieved. The new MISPE procedure provided a successful clean-up for the determination of CoQ10 in a complex matrix. Copyright © 2013 Elsevier B.V. All rights reserved.

  5. Interaction of coenzyme Q10 with the intestinal drug transporter P-glycoprotein.

    Science.gov (United States)

    Itagaki, Shirou; Ochiai, Akiko; Kobayashi, Masaki; Sugawara, Mitsuru; Hirano, Takeshi; Iseki, Ken

    2008-08-27

    In clinical trials, patients usually take many kinds of drugs at the same time. Thus, drug-drug interactions can often directly affect the therapeutic safety and efficacy of many drugs. Oral delivery is the most desirable means of drug administration. Changes in the activity of drug transporters may substantially influence the absorption of administered drugs from the intestine. However, there have been a few studies on food-drug interactions involving transporters. It is important to be aware of the potential of food-drug interactions and to act in order to prevent undesirable and harmful clinical consequences. Coenzyme Q10 (CoQ10) is very widely consumed by humans as a food supplement because of its recognition by the public as an important nutrient in supporting human health. Since intestinal efflux transporter P-glycoprotein (P-gp) is one of the major factors in drug-drug interactions, we focused on this transporter. We report here for the first time that CoQ10, which is widely used as a food supplement, affects the transport activity of P-gp.

  6. Coenzyme Q10 Protects Hippocampal Neurons Against Ischemia/Reperfusion Injury via Modulation of BAX/Bcl-2 Expression

    Directory of Open Access Journals (Sweden)

    M Zamani

    2012-12-01

    Full Text Available Introduction : Preliminary studies confirmed reduction in cell death following treatment with antioxidants. According to this finding we study the relationship between consumption of CoQ10 and expression of bax and bcl2 in hippocampus following ischemia/reperfusion as proteins involved in cell programmed death or apoptosis.Material & methods : We studied the protective role of CoQ10 against Ischemia-Reperfusion. Experimental design includes four groups: intact, ischemic control, sham control and treatment groups with CoQ10. The mice treated with CoQ10 as Pre - Treatment for a week. Then, ischemia induced by common carotid artery ligation and following the reduction in inflammation (a week the mice post-treated with CoQ10.Nissl staining applied to counting necrotic cells of hippocampus and the western blotting performed to measurement the bax and bcl2 expression.Results :. Cell death was significantly lower when mice treated with CoQ10. Bax expression was significantly high in ischemic group but in treatment group was less and reversely the bcl2 expression in ischemic group was lower than treatment and vehicle groups.Conclusion : Ischemia for 15 minutes induced cell death in hippocampus with more potent effect on CA1. CoQ10 intake significantly reduced cell death and prevented the expression of bax while inducing an increase in expression of bcl2.

  7. The Antioxidant Status and Concentrations of Coenzyme Q10 and Vitamin E in Metabolic Syndrome

    Directory of Open Access Journals (Sweden)

    Chi-Hua Yen

    2013-01-01

    Full Text Available The purpose of this study was to investigate the levels of coenzyme Q10 and vitamin E and the antioxidant status in subjects with metabolic syndrome (MS. Subjects with MS (n=72 were included according to the criteria for MS. The non-MS group (n=105 was comprised of healthy individuals with normal blood biochemical values. The plasma coenzyme Q10, vitamin E concentrations, lipid profiles, and antioxidant enzymes levels (catalase, superoxide dismutase, and glutathione peroxidase were measured. The subjects with MS had significantly higher concentrations of plasma coenzyme Q10 and vitamin E than those in the non-MS group, but these differences were not significant after being normalized for triglyceride level. The levels of antioxidant enzymes were significantly lower in the MS group than in the non-MS group. The subjects with the higher antioxidant enzymes activities had significant reductions in the risk of MS (P<0.01 after being adjusted for coenzyme Q10 and vitamin E. In conclusion, the subjects with MS might be under higher oxidative stress resulting in low levels of antioxidant enzyme activities. A higher level of antioxidant enzymes activities was significantly associated with a reduction in the risk of MS independent of the levels of coenzyme Q10 and vitamin E.

  8. The need for a transparent, ethical, and successful relationship between academic scientists and the pharmaceutical industry: a view of the Group for the Respect of Ethics and Excellence in Science (GREES).

    Science.gov (United States)

    Bruyere, O; Kanis, J A; Ibar-Abadie, M-E; Alsayed, N; Brandi, M L; Burlet, N; Cahall, D L; Chines, A; Devogelaer, J-P; Dere, W; Goel, N; Hughes, N; Kaufman, J-M; Korte, S; Mitlak, B H; Niese, D; Rizzoli, R; Rovati, L C; Reginster, J-Y

    2010-05-01

    This paper provides recommendations for fair and unbiased relationship between academic scientists and the pharmaceutical industry. Real or perceived problems in the relationship between academics and the industry have been the subject of much recent debate. It has been suggested that academic clinicians should sever all links with the industry-a view that is rarely challenged. Academic experts and members of the pharmaceutical industry were invited to an expert consensus meeting to debate this topic. This meeting was organized by the Group for the Respect of Ethics and Excellence in Science. Conflict of interest, competing interest, right and duties of academic scientist, authorship, and staff and student education were discussed. Guidelines for a transparent, ethical, strong, and successful partnership between the academic scientist and the pharmaceutical industry have been provided. The Group support interactions between the industry and clinicians provided that it is transparent and ethical.

  9. Application of Coenzyme Q10 for Accelerating Soft Tissue Wound Healing after Tooth Extraction in Rats

    Directory of Open Access Journals (Sweden)

    Toshiki Yoneda

    2014-12-01

    Full Text Available Accelerating wound healing after tooth extraction is beneficial in dental treatment. Application of antioxidants, such as reduced coenzyme Q10 (rCoQ10, may promote wound healing after tooth extraction. In this study, we examined the effects of topical application of rCoQ10 on wound healing after tooth extraction in rats. After maxillary first molars were extracted, male Fischer 344 rats (8 weeks old (n = 27 received topical application of ointment containing 5% rCoQ10 (experimental group or control ointment (control group to the sockets for 3 or 8 days (n = 6–7/group. At 3 days after extraction, the experimental group showed higher collagen density and lower numbers of polymorphonuclear leukocytes in the upper part of socket, as compared to the control group (p < 0.05. Gene expression of interleukin-1β, tumor necrosis factor-α and nuclear factor-κB were also lower in the experimental group than in the control group (p < 0.05. At 8 days after tooth extraction, there were no significant differences in collagen density, number of polymorphonuclear leukocytes and bone fill between the groups. Our results suggest that topical application of rCoQ10 promotes wound healing in the soft tissue of the alveolar socket, but that rCoQ10 has a limited effect on bone remodeling in rats.

  10. Experimental cross sections for two-electron capture into nitrogen autoionising states in Nsup(q+) (q=6,7) on He and H/sub 2/ collisions at 10. 5q keV

    Energy Technology Data Exchange (ETDEWEB)

    Bordenave-Montesquieu, A.; Benoit-Cattin, P.; Gleizes, A.; Marrakchi, A.I.; Dousson, S.; Hitz, D.

    1985-07-01

    Singly differential cross sections for two-electron capture into autoionising states (nl,n'l') with n=2,3,4 and n'>=n in Nsup(q+) (q=6,7) on He and H/sub 2/ collisions have been measured at 10,5q ke V collision energy and an observation angle thetasub(lab)=11.6/sup 0/. Total cross sections are estimated assuming isotropic angular distributions. (orig.).

  11. Blepharophimosis and mental retardation (BMR) phenotypes caused by chromosomal rearrangements: description in a boy with partial trisomy 10q and monosomy 4q and review of the literature.

    Science.gov (United States)

    Bartholdi, Deborah; Toelle, Sandra P; Steiner, Bernhard; Boltshauser, Eugen; Schinzel, Albert; Riegel, Mariluce

    2008-01-01

    Blepharophimosis is a rare congenital anomaly of the palpebral fissure which is often associated with mental retardation and additional malformations. We report on a boy with blepharophimosis, ptosis and severe mental retardation carrying an unbalanced 4;10 translocation with terminal duplication of 10q [dup(10)(q25.1-->qter)] and monosomy of a small terminal segment of chromosome 4q [del(4)(34.3-->qter)]. Detailed clinical examination and review of the literature showed that the phenotype of the patient was mainly determined by the dup(10q). This paper reviews the chromosomal aberrations associated with BMR (blepharophimosis mental retardation) phenotypes. Searching different databases and reviewing the literature revealed 14 microscopically visible aberrations (among them UPD(14)pat) and two submicroscopic rearrangements causing blepharophimosis and mental retardation (BMR) syndrome. Some of these rearrangements-like the terminal dup(10q) identified in our patient or interstitial del(2q)-are associated with clearly defined phenotypes and can be well distinguished from each other on basis of clinical examination. This paper should assist clinicians and cytogeneticists when evaluating patients with BMR syndrome.

  12. Interactions between physicians and the pharmaceutical industry generally and sales representatives specifically and their association with physicians' attitudes and prescribing habits: a systematic review.

    Science.gov (United States)

    Fickweiler, Freek; Fickweiler, Ward; Urbach, Ewout

    2017-09-27

    The objective of this review is to explore interactions between physicians and the pharmaceutical industry including sales representatives and their impact on physicians' attitude and prescribing habits. PubMed, Embase, Cochrane Library and Google scholar electronic databases were searched from 1992 to August 2016 using free-text words and medical subject headings relevant to the topic. Studies included cross-sectional studies, cohort studies, randomised trials and survey designs. Studies with narrative reviews, case reports, opinion polls and letters to the editor were excluded from data synthesis. Two reviewers independently extracted the data. Data on study design, study year, country, participant characteristics, setting and number of participants were collected. Pharmaceutical industry and pharmaceutical sales representative (PSR) interactions influence physicians' attitudes and their prescribing behaviour and increase the number of formulary addition requests for the company's drug. Physician-pharmaceutical industry and its sales representative's interactions and acceptance of gifts from the company's PSRs have been found to affect physicians' prescribing behaviour and are likely to contribute to irrational prescribing of the company's drug. Therefore, intervention in the form of policy implementation and education about the implications of these interactions is needed. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  13. Coenzyme Q10 Inhibits the Aging of Mesenchymal Stem Cells Induced by D-Galactose through Akt/mTOR Signaling

    Directory of Open Access Journals (Sweden)

    Dayong Zhang

    2015-01-01

    Full Text Available Increasing evidences indicate that reactive oxygen species are the main factor promoting stem cell aging. Recent studies have demonstrated that coenzyme Q10 (CoQ10 plays a positive role in organ and cellular aging. However, the potential for CoQ10 to protect stem cell aging has not been fully evaluated, and the mechanisms of cell senescence inhibited by CoQ10 are still poorly understood. Our previous study had indicated that D-galactose (D-gal can remarkably induce mesenchymal stem cell (MSC aging through promoting intracellular ROS generation. In this study, we showed that CoQ10 could significantly inhibit MSC aging induced by D-gal. Moreover, in the CoQ10 group, the expression of p-Akt and p-mTOR was clearly reduced compared with that in the D-gal group. However, after Akt activating by CA-Akt plasmid, the senescence-cell number in the CoQ10 group was significantly higher than that in the control group. These results indicated that CoQ10 could inhibit D-gal-induced MSC aging through the Akt/mTOR signaling.

  14. Legal considerations for social media marketing by pharmaceutical industry.

    Science.gov (United States)

    Yang, Y Tony; Chen, Brian

    2014-01-01

    Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.

  15. Stability-Indicating HPLC Assay for Determination of Idebenone in Pharmaceutical Forms

    Directory of Open Access Journals (Sweden)

    Sonoube Kombath

    2015-01-01

    Full Text Available A stability-indicating method was validated for the determination in pharmaceutical forms of idebenone a coenzyme Q10-like compound. The assay was achieved by liquid chromatography analysis using a reversed-phase C18 column and a detector set at 480 nm. The optimized mobile phase consisted of isocratic flow rate at 1.0 mL/min for 3 min with methanol. The linearity of the assay was demonstrated in the range of 3.0 to 8.0 mg/mL with a correlation coefficient r2>0.998. The limits of detection and quantification were 0.03 and 0.05 mg/mL, respectively. The intraday and interday precisions were less than 1.0%. Accuracy of the method ranged from 98.6 to 101.5% with RSD < 0.6%. Specificity of the assay showed no interference from tablets components and breakdown products formed by alkaline, acidic, oxidative, sunlight, and high temperature conditions. This method allows accurate and reliable determination of idebenone for drug stability assay in pharmaceutical studies.

  16. Pharmaceutical policies in European countries.

    Science.gov (United States)

    Barros, Pedro Pita

    2010-01-01

    Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers. To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies. Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a "silver bullet" to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).

  17. Paraquat induces oxidative stress and neuronal cell death; neuroprotection by water-soluble Coenzyme Q10

    International Nuclear Information System (INIS)

    McCarthy, S.; Somayajulu, M.; Sikorska, M.; Borowy-Borowski, H.; Pandey, S.

    2004-01-01

    Neuronal cell death induced by oxidative stress is correlated with numerous neurodegenerative diseases, including Alzheimer's disease (AD), Parkinson's disease (PD), and stroke. The causes of sporadic forms of age-related neurodegenerative diseases are still unknown. Recently, a correlation between paraquat exposure and neurodegenerative diseases has been observed. Paraquat, a nonselective herbicide, was once widely used in North America and is still routinely used in Taiwan. We have used differentiated Human Neuroblastoma (SHSY-5Y) cells as an in vitro model to study the mechanism of cell death induced by paraquat. We observed that paraquat-induced oxidative stress in differentiated SHSY-5Y cells as indicated by an increase in the production of cellular reactive oxygen species (ROS). Furthermore, apoptosis was evident as indicated by cellular and nuclear morphology and DNA fragmentation. Interestingly, pretreatment of SHSY-5Y cells with water-soluble Coenzyme Q 10 (CoQ 10 ) before paraquat exposure inhibited ROS generation. Pretreatment with CoQ 10 also significantly reduced the number of apoptotic cells and DNA fragmentation. We also analyzed the effect of paraquat and CoQ 10 on isolated mitochondria. Our results indicated that treatment with paraquat induced the generation of ROS from isolated mitochondria and depolarization of the inner mitochondrial membrane. Pretreatment with CoQ 10 was able to inhibit ROS generation from isolated mitochondria as well as the collapse of mitochondrial membrane potential. Our results indicate that water-soluble CoQ 10 can prevent oxidative stress and neuronal damage induced by paraquat and therefore, can be used for the prevention and therapy of neurodegenerative diseases caused by environmental toxins

  18. Coenzyme Q10 Protects Hippocampal Neurons against Ischemia/ Reperfusion Injury via Modulation of BAX/Bcl-2 Expression

    Directory of Open Access Journals (Sweden)

    Mohammad Zamani

    2012-09-01

    Full Text Available Introduction: Preliminary studies have con.rmed reduction in cell death following treatment with antioxidants. According to this .nding we study the relationship between consumption of CoQ10 and expression of Bax and Bcl2 in hippocampus following ischemia/reperfusion as proteins involved in cell programmed death or apoptosis. Methods: We studied the protective role of CoQ10 against ischemia-reperfusion. Experimental design includes four groups:  intact, ischemic control, sham control and treatment group with CoQ10. The mice were pre-treated with CoQ10 for a week, then ischemia was induced by common carotid artery ligation and following the reduction in in.ammation (a week the mice was treated with CoQ10.  Nissl staining was applied for counting the necrotic cells of hippocampus and the western blot was performed to measure the Bax and Bcl2 expression.Results: Cell death was signi.cantly lower when mice were treated with CoQ10. Bax expression was signi.cantly high in the ischemic group but low in the treatment group, and the bcl2 expression was lower in the ischemic group than the treatment and the vehicle groups.Discussion: Ischemia for 15 minutes induced cell death in hippocampus with more potent effect on CA1. CoQ10 intake signi.cantly reduced cell death and prevented the expression of Bax while inducing an increase in expression of bcl2.

  19. Coenzyme Q10, α-Tocopherol, and Oxidative Stress Could Be Important Metabolic Biomarkers of Male Infertility

    Directory of Open Access Journals (Sweden)

    Anna Gvozdjáková

    2015-01-01

    Full Text Available Oxidative stress, decreased antioxidant capacity, and impaired sperm mitochondrial function are the main factors contributing to male infertility. The goal of the present study was to assess the effect of the per os treatment with Carni-Q-Nol (440 mg L-carnitine fumarate + 30 mg ubiquinol + 75 IU vitamin E + 12 mg vitamin C in each softsule in infertile men on sperm parameters, concentration of antioxidants (coenzyme Q10,  CoQ10-TOTAL, γ, and α-tocopherols, and oxidative stress in blood plasma and seminal fluid. Forty infertile men were supplemented daily with two or three Carni-Q-Nol softsules. After 3 and 6 months of treatment, improved sperm density was observed (by 48.9% and 80.9%, resp. and after 3-month treatment the sperm pathology decreased by 25.8%. Concentrations of CoQ10-TOTAL (ubiquinone + ubiquinol and α-tocopherol were significantly increased and the oxidative stress was decreased. In conclusion, the effect of supplementary therapy with Carni-Q-Nol showed benefits on sperm function in men, resulting in 45% pregnancies of their women. We assume that assessment of oxidative stress, CoQ10-TOTAL, and α-tocopherol in blood plasma and seminal fluid could be important metabolic biomarkers in both diagnosis and treatment of male infertility.

  20. The politics and strategy of industry self-regulation: the pharmaceutical industry's principles for ethical direct-to-consumer advertising as a deceptive blocking strategy.

    Science.gov (United States)

    Arnold, Denis G; Oakley, James L

    2013-06-01

    As the pharmaceutical industry lobbies European regulators to permit direct-to-consumer advertising (DTCA) of prescription drugs in the European Union, we found that five leading companies violated industry-developed and -promulgated standards for ethical advertising in the United States. Utilizing multiple data sources and methods, we demonstrate a consistent failure by companies that market erectile dysfunction drugs to comply with the industry's guiding principles for ethical DTCA over a four-year period despite pledges of compliance by company leaders. Noncompliance resulted in children being exposed to sexually themed promotional messages more than 100 billion times. We argue that the guidelines are a coordinated effort by the industry to prevent unwanted federal regulation, and we introduce the concept of a blocking strategy to explain company behavior and to advance theoretical understanding of firms' public affairs strategies. We recommend policy responses to prevent deceptive practices, protect children from adult content, and promote genuine health care education.

  1. 31 CFR 30.10 - Q-10: What actions are necessary for a TARP recipient to comply with section 111(b)(3)(D) of EESA...

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Q-10: What actions are necessary for....10 Section 30.10 Money and Finance: Treasury Office of the Secretary of the Treasury TARP STANDARDS FOR COMPENSATION AND CORPORATE GOVERNANCE § 30.10 Q-10: What actions are necessary for a TARP...

  2. The antioxidant status of coenzyme Q10 and vitamin E in children with type 1 diabetes.

    Science.gov (United States)

    Alkholy, Usama M; Abdalmonem, Nermin; Zaki, Ahmed; Elkoumi, Mohamed A; Hashim, Mustafa I Abu; Basset, Maha A A; Salah, Hossam E

    2018-02-07

    The purpose of this study was to evaluate the antioxidant status of plasma vitamin E and plasma and intracellular coenzyme Q10 in children with type 1 diabetes. This case-control study was conducted on 72 children with type 1 diabetes and compared to 48 healthy children, who were age, sex, and ethnicity-matched. The diabetic children were divided according to their glycosylated hemoglobin (A1c %) into two groups: poor and good glycemic control groups. All children underwent full history taking, clinical examination, and laboratory measurement of complete blood count, A1c %, plasma cholesterol, triglycerides, and vitamin E levels and coenzyme Q10 levels in plasma, erythrocytes, and platelets. Children with poor glycemic control showed significantly higher plasma vitamin E, coenzyme Q10, triglycerides, low-density lipoproteins, waist circumference/height ratio, cholesterol levels, and lower high-density lipoproteins and platelet coenzyme Q10 redox status in comparison to those with good glycemic control and the control group (p<0.05). Plasma coenzyme Q10 showed a positive correlation with the duration of type 1 diabetes, triglycerides, cholesterol, vitamin E, and A1c %, and negative correlation with the age of the diabetic group (p<0.05). The platelet redox status showed a negative correlation with the A1c % levels (r=-0.31; p=0.022) and the duration of type 1 diabetes (r=-0.35, p=0.012). Patients with type 1 diabetes, especially poorly controlled, had elevation of plasma vitamin E and coenzyme Q10 levels and decreased platelet redox status of coenzyme Q10, which may be an indicator of increased oxidative stress. Copyright © 2018 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

  3. Approaches to education of pharmaceutical biotechnology in faculties of pharmacy.

    Science.gov (United States)

    Calis, S; Oner, F; Kas, S; Hincal, A A

    2001-06-01

    Pharmaceutical biotechnology is developing rapidly both in academic institutions and in the biopharmaceutical industry. For this reason, FIP Special Interest Group of Pharmaceutical Biotechnology decided to develop a questionnaire concerning pharmaceutical biotechnology education. After preliminary studies were completed, questionnaires were sent to the leading scientists in academia and research directors or senior managers of various Pharmaceutical Biotechnology Companies in order to gather their views about how to create a satisfactory program. The objectives of this study were as follows: -To review all of the graduate and undergraduate courses which are presently available worldwide on pharmaceutical biotechnology in Faculties of Pharmacy. -To review all of the text books, references and scientific sources available worldwide in the area of pharmaceutical biotechnology. When replying to the questionnaires, the respondents were asked to consider the present status of pharmaceutical biotechnology education in academia and future learning needs in collaboration with the biotechnology industry. The data from various pharmacy faculties and biotechnology industry representatives from Asia, Europe and America were evaluated and the outcome of the survey showed that educational efforts in training qualified staff in the rapidly growing field of pharmaceutical biotechnology is promising. Part of the results of this questionnaire study have already been presented at the 57th International Congress of FIP Vancouver, Canada in 1997.

  4. The Pharmaceutical Sector of Kazakhstan's Economy: Trends and Problems

    Science.gov (United States)

    Nurpeisov, Borankul G.; Nabiev, Erboz N.; Mukashev, Temirbay A.; Daribekov, Serik S.; Raimbekov, Bagdat Kh.; Asanova, Maral K.; Bazarbaeva, Leila M.

    2016-01-01

    This research is devoted to the investigation of the general trends in the development of the pharmaceutical industry in the current conditions of economical socialization. The determination of the economic specificity of the modern operation of the pharmaceutical industry is the purpose of the research. It was found that pharmacy is a profitable…

  5. Determinants of Pharmaceutical Industry’s Performance in Nigeria

    Directory of Open Access Journals (Sweden)

    Wakeel A. Isola

    2016-09-01

    Full Text Available This study focused on the relationships amongmarket structure, efficiency and performance of the Nigerian Pharmaceutical industry. It employed market share and operational efficiency to determine the efficiency of the industry, pre-tax return on asset to measure performance, Herfindahl- Hirschman index to measure market structure. In addition, earnings per share was used in the study as control variable. Data were obtained from the Nigerian Stock Market Factbook covering 1996 to 2010. The panel ordinary least squares technique was employed in estimating the data. Thus over the course of the study, both fixed and random effect results clearly showed that efficiency hypothesis does not hold in the case of pharmaceutical industry in Nigeria. Rather, it is shown that it is structure that determines performance. Consequently, the study recommended that necessary structures must be put in place by the Federal Ministry of Health to enhance the capacity of local pharmaceutical firms in producing the desired quality and quantity drugs needed in the country. It was also recommended that efforts should be geared towards eradicating totally the importation of fake drugs in the pharmaceutical industry.

  6. Coenzyme Q10: A New Treatment for Hemorrhagic Shock

    Science.gov (United States)

    2014-10-29

    SUBJECT TERMS hemorrhagic shock, ubiquinol, Coenzyme Q10, patient outcome 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18...o leo& to tboOigllll failure. The < Iota fur AlM •1 ha"’ boon ._...runym.,..,; •• ted in p=en~atlons and publiobed tn Expu""’""" P/u<llology. Tho

  7. Fine mapping of a de novo interstitial 10q22-q23 duplication in a patient with congenital heart disease and microcephaly

    DEFF Research Database (Denmark)

    Erdogan, F; Belloso, J M; Gabau, E

    2008-01-01

    deletions or duplications elsewhere in the genome. The main clinical features of the patient are microcephaly and congenital heart disease, which are likely to be caused by dosage effect of one or several genes in the duplicated region. Similar phenotypes have been found in other patients with 10q11-q22...

  8. Non-Price Competition and the Structure of the Online Information Industry: Q-Analysis of Medical Databases and Hosts.

    Science.gov (United States)

    Davies, Roy

    1987-01-01

    Discussion of the online information industry emphasizes the effects of non-price competition on its structure and the firms involved. Q-analysis is applied to data on medical databases and hosts, changes over a three-year period are identified, and an optimum structure for the industry based on economic theory is considered. (Author/LRW)

  9. Exploring Multidimensional View of Intellectual Capital and Business Ethics on Organizational Performance by Using Bootstrapping Method: Evidence from Pakistani Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Rizwan Raheem Ahmed

    2017-03-01

    Full Text Available The objective of this research is to examine the effect of business ethics (BE and intellectual capital (IC on the organizational performance (OP. In order to run this study, a conceptual model was designed based on the literature review, and the employees of the knowledge-based organization in pharmaceutical sector were surveyed using a closed-ended questionnaire. Modern successful and thriving organizations are those that create IC and convert it into applicable methods to improve their activities and performance within the boundaries of BE. This research is exploratory and quantitative in nature: 400 responses were directly gathered from the employees of the pharmaceutical industry through five-scaled questionnaire. This research examined the direct and indirect effect of BE and IC on the OP. Structural equation modeling (SEM, descriptive statistics, correlation, multiple regression techniques were used to analyze the impact of IC and BE on the performance. Bootstrapping method is employed in order to test the mediating effect of variables. Two-step SEM was used to the models to regress the cause and effect relation. The findings depicted that there is a very significant effect on BE and IC in the performance of pharmaceutical organizations. General BE, ethics in finance, ethics in human resource management, and ethics in sales and marketing have direct and significant impact on the OP. Human capital, structural capital and relational capital have significant indirect (mediating effect on the performance of the pharmaceutical industry. Finally, it has been concluded from the results of the research study that IC is the major contributor of the OP as a mediating variable with defined set of principles of BE in the pharmaceutical sector of Pakistan.

  10. Pharmaceuticals, political money, and public policy: a theoretical and empirical agenda.

    Science.gov (United States)

    Jorgensen, Paul D

    2013-01-01

    Why, when confronted with policy alternatives that could improve patient care, public health, and the economy, does Congress neglect those goals and tailor legislation to suit the interests of pharmaceutical corporations? In brief, for generations, the pharmaceutical industry has convinced legislators to define policy problems in ways that protect its profit margin. It reinforces this framework by selectively providing information and by targeting campaign contributions to influential legislators and allies. In this way, the industry displaces the public's voice in developing pharmaceutical policy. Unless citizens mobilize to confront the political power of pharmaceutical firms, objectionable industry practices and public policy will not change. Yet we need to refine this analysis. I propose a research agenda to uncover pharmaceutical influence. It develops the theory of dependence corruption to explain how the pharmaceutical industry is able to deflect the broader interests of the general public. It includes empirical studies of lobbying and campaign finance to uncover the means drug firms use to: (1) shape the policy framework adopted and information used to analyze policy; (2) subsidize the work of political allies; and (3) influence congressional voting. © 2013 American Society of Law, Medicine & Ethics, Inc.

  11. Constraining the Q10 of respiration in water-limited environments

    Science.gov (United States)

    Collins, A.; Ryan, M. G.; Xu, C.; Grossiord, C.; Michaletz, S. T.; McDowell, N. G.

    2016-12-01

    If the current rate of greenhouse emissions remains constant over the next few decades, projections of climate change forecast increased atmospheric temperatures by a least 1.1°C by the end of the century. Warmer temperatures are expected to largely influence the exchange of energy, carbon and water between plants and the atmosphere. Several studies support that terrestrial ecosystems currently act as a major carbon sink, however warmer temperatures may amplify respiration processes and shift terrestrial ecosystems from a sink to a source of carbon in the future. Most Earth System Models incorporate the temperature dependence of plant respiration (Q10) to estimate and predict respiration processes and associated carbon fluxes. Using a temperature and precipitation manipulation experiment in natural conditions, we present evidence that this parameter is poorly constrained especially in water-limited environments. We discuss the utility of the Q10 framework and suggest improvements for this parameter along with trait-based approaches to better resolve models.

  12. Process Analytical Technology for Crystallization of Active Pharmaceutical Ingredients

    DEFF Research Database (Denmark)

    Malwade, Chandrakant Ramkrishna; Qu, Haiyan

    2018-01-01

    Background: Pharmaceutical industry is witnessing increased pressure to introduce innovative and efficient processes for manufacturing of Active Pharmaceutical Ingredients (APIs) in order to be competitive as well as to meet the stringent product quality requirements set by regulatory authorities...... parameters and their impact on quality of APIs and subsequently the drug products assume great significance for pharmaceutical industry. Methods: This review paper focuses on application of PAT tools, an integral part of Quality by Design (QbD) approach, for better understanding, control, and design...

  13. RISK-FACTORS, PATHOGENESIS, AND PHARMACEUTICAL APPROACHES FOR TREATMENT OF STEROID-INDUCED BONE INFARCTION OF FEMORAL HEAD.

    Science.gov (United States)

    Wang, Fei; Wang, Yang; Hu, Ningning; Miao, Xuman

    2016-01-01

    During first year of steroid usage, osteocyte necrosis and blood vessel blockage may occur, which subsequently may produce steroid-induced bone infarction (SIBI) resulting in painful movement of patient. For treatment of SIBI, pharmaceutical strategy is the basic approach. It involves the use of various pharmacologically active compounds including bisphosphonates, hyperbaric oxygen (HBO), coenzyme Q10, erythropoietin, antihyperlipidemics, anticoagulants, antioxidants, and tissue repair protein. Out of these, there is no pharmaceutical agent that may completely treat this disease because many factors are found to be responsible for SIBI development; therefore, there are multiple biomarkers of this disease. This situation argues for need of new therapeutic agents for SIEB1.

  14. Genomic Deletion at 10q23 in Prostate Cancer: More Than PTEN Loss?

    Directory of Open Access Journals (Sweden)

    Raghavendra Tejo Karthik Poluri

    2018-06-01

    Full Text Available The PTEN gene encodes for the phosphatase and tensin homolog; it is a tumor suppressor gene that is among the most frequently inactivated genes throughout the human cancer spectrum. The most recent sequencing approaches have allowed the identification of PTEN genomic alterations, including deletion, mutation, or rearrangement in about 50% of prostate cancer (PCa cases. It appears that mechanisms leading to PTEN inactivation are cancer-specific, comprising gene mutations, small insertions/deletions, copy number alterations (CNAs, promoter hypermethylation, and RNA interference. The examination of publicly available results from deep-sequencing studies of various cancers showed that PCa appears to be the only cancer in which PTEN is lost mostly through CNA. Instead of inactivating mutations, which are seen in other cancers, deletion of the 10q23 locus is the most common form of PTEN inactivation in PCa. By investigating the minimal deleted region at 10q23, several other genes appear to be lost simultaneously with PTEN. Expression data indicate that, like PTEN, these genes are also downregulated upon loss of 10q23. These analyses raise the possibility that 10q23 is lost upon selective pressure not only to inactivate PTEN but also to impair the expression of surrounding genes. As such, several genes from this deleted region, which represents about 500 kb, may also act as tumor suppressors in PCa, requiring further studies on their respective functions in that context.

  15. Coenzyme Q10 quantification in muscle, fibroblasts and cerebrospinal fluid by liquid chromatography/tandem mass spectrometry using a novel deuterated internal standard.

    Science.gov (United States)

    Duberley, Kate E C; Hargreaves, Iain P; Chaiwatanasirikul, Korn-Anong; Heales, Simon J R; Land, John M; Rahman, Shamima; Mills, Kevin; Eaton, Simon

    2013-05-15

    Neurological dysfunction is common in primary coenzyme Q10 (2,3-dimethoxy, 5-methyl, 6-polyisoprene parabenzoquinone; CoQ10 ; ubiquinone) deficiencies, the most readily treatable subgroup of mitochondrial disorders. Therapeutic benefit from CoQ10 supplementation has also been noted in other neurodegenerative diseases. CoQ10 can be measured by high-performance liquid chromatography (HPLC) in plasma, muscle or leucocytes; however, there is no reliable method to quantify CoQ10 in cerebrospinal fluid (CSF). Additionally, many methods use CoQ9 , an endogenous ubiquinone in humans, as an internal standard. Deuterated CoQ10 (d6 -CoQ10 ) was synthesised by a novel, simple, method. Total CoQ10 was measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) using d6 -CoQ10 as internal standard and 5 mM methylamine as an ion-pairing reagent. Chromatography was performed using a Hypsersil GOLD C4 column (150 × 3 mm, 3 µm). CoQ10 levels were linear over a concentration range of 0-200 nM (R(2) = 0.9995). The lower limit of detection was 2 nM. The inter-assay coefficient of variation (CV) was 3.6% (10 nM) and 4.3% (20 nM), and intra-assay CV 3.4% (10 nM) and 3.6% (20 nM). Reference ranges were established for CoQ10 in CSF (5.7-8.7 nM; n = 17), fibroblasts (57.0-121.6 pmol/mg; n = 50) and muscle (187.3-430.1 pmol/mg; n = 15). Use of d6 -CoQ10 internal standard has enabled the development of a sensitive LC/MS/MS method to accurately determine total CoQ10 levels. Clinical applications of CSF CoQ10 determination include identification of patients with cerebral CoQ10 deficiency, and monitoring CSF CoQ10 levels following supplementation. Copyright © 2013 John Wiley & Sons, Ltd.

  16. A survey of the effects of brand value on customer satisfaction in pharmaceutical and biological industries

    OpenAIRE

    Alipour, A.; Feizi, S.J.; Heidari, M.

    2016-01-01

    . The purpose of this study was to describe how companies in pharmaceutical and biological sectors can ensure their position in different markets by relying on sustainable, competitive advantages, resulting from the use of a well-defined marketing model with particular emphasis on brand improvement. As competition becomes more intense among companies and phenomena such as global marketing grow in importance, domestic industries in each country become obliged to improve their competitive advan...

  17. Marketing norm perception among medical representatives in Indian pharmaceutical industry.

    Science.gov (United States)

    Nagashekhara, Molugulu; Agil, Syed Omar Syed; Ramasamy, Ravindran

    2012-03-01

    Study of marketing norm perception among medical representatives is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the perception of marketing norms among medical representatives. The research design is quantitative and cross sectional study with medical representatives as unit of analysis. Data is collected from medical representatives (n=300) using a simple random and cluster sampling using a structured questionnaire. Results indicate that there is no difference in the perception of marketing norms among male and female medical representatives. But there is a difference in opinion among domestic and multinational company's medical representatives. Educational back ground of medical representatives also shows the difference in opinion among medical representatives. Degree holders and multinational company medical representatives have high perception of marketing norms compare to their counterparts. The researchers strongly believe that mandatory training on marketing norms is beneficial in decision making process during the dilemmas in the sales field.

  18. 22q11.2q13 duplication including SOX10 causes sex-reversal and peripheral demyelinating neuropathy, central dysmyelinating leukodystrophy, Waardenburg syndrome, and Hirschsprung disease.

    Science.gov (United States)

    Falah, Nadia; Posey, Jennifer E; Thorson, Willa; Benke, Paul; Tekin, Mustafa; Tarshish, Brocha; Lupski, James R; Harel, Tamar

    2017-04-01

    Diagnosis of genetic syndromes may be difficult when specific components of a disorder manifest at a later age. We present a follow up of a previous report [Seeherunvong et al., (2004); AJMGA 127: 149-151], of an individual with 22q duplication and sex-reversal syndrome. The subject's phenotype evolved to include peripheral and central demyelination, Waardenburg syndrome type IV, and Hirschsprung disease (PCWH; MIM 609136). DNA microarray analysis defined the duplication at 22q11.2q13, including SOX10. Sequencing of the coding region of SOX10 did not reveal any mutations. Our data suggest that SOX10 duplication can cause disorders of sex development and PCWH, supporting the hypothesis that SOX10 toxic gain of function rather than dominant negative activity underlies PCWH. © 2017 Wiley Periodicals, Inc.

  19. Alkaloids in the pharmaceutical industry: Structure, isolation and application

    Directory of Open Access Journals (Sweden)

    Nikolić Milan

    2003-01-01

    Full Text Available By the end of the 18th and the beginning of the 19th century a new era began in medicine, pharmaceutics and chemistry that was strongly connected with alkaloids and alkaloid drugs. Even before that it was known that certain drugs administered in limited doses were medicines, and toxic if taken in larger doses (opium, coke leaves, belladonna roots, monkshood tubers crocus or hemlock seeds. However, the identification, isolation and structural characterization of the active ingredients of the alkaloid drugs was only possible in the mid 20th century by the use of modern extraction equipment and instrumental methods (NMR, X-ray diffraction and others.In spite of continuing use over a long time, there is still great interest in investigating new drugs, potential raw materials for the pharmaceutical industry, as well as the more detailed investigation and definition of bio-active components and the indication of their activity range, and the partial synthesis of new alkaloid molecules based on natural alkaloids. The scope of these investigations, especially in the field of semi-synthesis is to make better use of the bio-active ingredients of alkaloid drugs, i.e. to improve the pharmacological effect (stronger and prolonged effect of the medicine, decreased toxicity and side effects, or to extend or change the applications. A combined classification of alkaloids was used, based on the chemical structure and origin, i.e. the source of their isolation to study alkaloid structure. For practical reasons, the following classification of alkaloids was used: ergot alkaloids, poppy alkaloids, tropanic alkaloids purine derivative alkaloids, carbon-cyclic alkaloids, and other alkaloids. The second part of this report presents a table of general procedures for alkaloid isolation from plant drugs (extraction by water non-miscible solvents, extraction by water-miscible solvents and extraction by diluted acid solutions. Also, methods for obtaining chelidonine and

  20. Self-Nanoemulsifying Drug Delivery System of Coenzyme (Q10) with Improved Dissolution, Bioavailability, and Protective Efficiency on Liver Fibrosis.

    Science.gov (United States)

    Khattab, Abeer; Hassanin, Lobna; Zaki, Nashwah

    2017-07-01

    The aim of our investigation is to develop and characterize self-nanoemulsifying drug delivery systems (SNEDDS) of CoQ 10 to improve its water solubility, dissolution rate, and bioavailability, and then evaluate its biochemical and physiological effect on liver cirrhosis in rats compared with CoQ 10 powder. SNEDDS are isotropic and thermodynamically stable mixture of oil, surfactant, co-surfactant, and drug that form an oil/water nanoemulsion when added to aqueous phases with soft agitation. Upon administration, self-nanoemulsifying system becomes in contact with gastrointestinal fluid and forms o/w nanoemulsion by the aid of gastrointestinal motility. When the nanoemulsion is formed in the gastrointestinal tract, it presents the drug in a solubilized form inside small nano-sized droplets that provide a large surface area for enhancing the drug release and absorption. Solubility of CoQ 10 in various oils, surfactants, and co-surfactants were studied to identify the components of SNEDDS; pseudo-ternary phase diagrams were plotted to identify the efficient self-emulsifying regions. CoQ 10 -loaded SNEDDS were prepared using isopropyl myristate as oil; Cremophor El, Labrasol, or Tween80 as surfactant; and Transcutol as co-surfactant. The amount of CoQ 10 in each vehicle was 3%. The formulations that passed thermostability evaluation test were assessed for particle size analysis, morphological characterization, refractive index, zeta potential, viscosity, electroconductivity, drug release profile, as well as ex vivo permeability. Pharmacokinetics and hepatoprotective efficiency of the optimized SNEDDS of CoQ 10 compared with CoQ 10 suspension were performed. Results showed that all optimized formulae have the ability to form a good and stable nanoemulsion when diluted with water; the mean droplet size of all formulae was in the nanometric range (11.7-13.5 nm) with optimum polydispersity index values (0.2-0.21). All formulae showed negative zeta potential (-11.3 to -17

  1. Compound Heterozygous Inheritance of Mutations in Coenzyme Q8A Results in Autosomal Recessive Cerebellar Ataxia and Coenzyme Q10 Deficiency in a Female Sib-Pair.

    Science.gov (United States)

    Jacobsen, Jessie C; Whitford, Whitney; Swan, Brendan; Taylor, Juliet; Love, Donald R; Hill, Rosamund; Molyneux, Sarah; George, Peter M; Mackay, Richard; Robertson, Stephen P; Snell, Russell G; Lehnert, Klaus

    2017-11-21

    Autosomal recessive ataxias are characterised by a fundamental loss in coordination of gait with associated atrophy of the cerebellum. There is significant clinical and genetic heterogeneity amongst inherited ataxias; however, an early molecular diagnosis is essential with low-risk treatments available for some of these conditions. We describe two female siblings who presented early in life with unsteady gait and cerebellar atrophy. Whole exome sequencing revealed compound heterozygous inheritance of two pathogenic mutations (p.Leu277Pro, c.1506+1G>A) in the coenzyme Q8A gene (COQ8A), a gene central to biosynthesis of coenzyme Q (CoQ). The paternally derived p.Leu277Pro mutation is predicted to disrupt a conserved motif in the substrate-binding pocket of the protein, resulting in inhibition of CoQ 10 production. The maternal c.1506+1G>A mutation destroys a canonical splice donor site in exon 12 affecting transcript processing and subsequent protein translation. Mutations in this gene can result in primary coenzyme Q 10 deficiency type 4, which is characterized by childhood onset of cerebellar ataxia and exercise intolerance, both of which were observed in this sib-pair. Muscle biopsies revealed unequivocally low levels of CoQ 10, and the siblings were subsequently established on a therapeutic dose of CoQ 10 with distinct clinical evidence of improvement after 1 year of treatment. This case emphasises the importance of an early and accurate molecular diagnosis for suspected inherited ataxias, particularly given the availability of approved treatments for some subtypes.

  2. Funding pharmaceutical innovation through direct tax credits.

    Science.gov (United States)

    Lybecker, Kristina M; Freeman, Robert A

    2007-07-01

    Rising pharmaceutical prices, increasing demand for more effective innovative drugs and growing public outrage have heightened criticism of the pharmaceutical industry. The public debate has focused on drug prices and access. As a consequence, the patent system is being reexamined as an efficient mechanism for encouraging pharmaceutical innovation and drug development. We propose an alternative to the existing patent system, instead rewarding the innovating firm with direct tax credits in exchange for marginal cost pricing. This concept is based on the fundamental assumption that innovation that benefits society at large may be financed publicly. As an industry which produces a social good characterized by high fixed costs, high information and regulatory costs, and relatively low marginal costs of production, pharmaceuticals are well-suited to such a mechanism. Under this proposal, drug prices fall, consumer surplus increases, access is enhanced, and the incentives to innovate are preserved.

  3. Attitude and practice of dental surgeons towards pharmaceutical companies' marketing gifts.

    Science.gov (United States)

    Tahir, Shaila; Rafique, Adeela; Ghafoor, Farkhanda; Saleem, Akif; Khan, Amanullah

    2013-01-01

    Interaction of pharmaceutical companies (PC) with healthcare services has been a reason for concern. In medicine, awareness of the ethical implications of these interactions have been emphasized upon, while this issue has not been highlighted in dentistry. This study undertook a cross-sectional rapid assessment procedure to gather views of dentists in various institutions towards unethical practices in health care and pharmaceutical industry. The purpose of this study was to assess the need for the formulation and implementation of guidelines for the interaction of dentists with the pharmaceutical and device industry in the best interest of patients. A group of 209 dentists of Lahore including faculty members, demonstrators, private practitioners and fresh graduates responded to a questionnaire to assess their attitudes and practices towards pharmaceutical companies' marketing gifts. The study was conducted during 2011 and provided interesting data that showed the pharmaceutical industry is approaching private practitioners more frequently than academicians and fresh graduates. Private practioners accepted the gifts but mostly recognized them as unethical (over 65%). Both groups considered sponsoring of on-campus lectures as acceptable (over 70%). Respondents are not fully aware of the ethical demands which are imperative for all health care industries, and there is a dire need of strict guidelines and code of ethics for the dentist's interaction with the pharmaceutical and device industry so that patient interest is protected.

  4. Continuous improvement concepts as a link between quality assurance and implementation of cleaner production: Case study in the generic pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Boltić Zorana

    2016-01-01

    Full Text Available The subject and the research objective presented in this article is establishing of the relationship between quality assurance and implementation of cleaner production in the generic pharmaceutical industry through the comprehensive concept of continuous improvement. This is mostly related to application of Lean and Six Sigma tools and techniques for process improvement and their link to other known concepts used in the industrial environment, especially manufacturing of generic pharmaceutical products from which two representative case studies were selected for comparative analysis, also considering relevant regulatory requirements in the field of quality management, as well as appropriate quality standards. Although the methodology discussed in this conceptual and practice oriented article is strongly related to chemical engineering, the focus is mainly on process industry, i.e. production systems, rather than any specific technological process itself. The scope of this research is an engineering approach to evaluation of the production systems in terms of continuous improvement concepts application, considering both quality aspects and efficiency of such systems. [Projekat Ministarstva nauke Republike Srbije, br. TR 34009

  5. The Industry of Pharmaceuticals between Competitive Development and Welfare

    OpenAIRE

    Gianfrate Fabrizio

    2007-01-01

    This paper would like to give a contribution to the discussion on which policies and rules should be adopted in order to relaunch the pharmaceutical sector in Italy. Due to its intrinsic features, social value and being one of the most regulated and strategic as based on innovation, this sector has higly specific economic and market peculiarities. Compatibility between the level of NHS expenditure for pharmaceutical provision, equity on medicines acces by the population without any kind of di...

  6. Knowledge, Beliefs and Attitudes of Patients and the General Public towards the Interactions of Physicians with the Pharmaceutical and the Device Industry: A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Racha Fadlallah

    Full Text Available To systematically review the evidence on the knowledge, beliefs, and attitudes of patients and the general public towards the interactions of physicians with the pharmaceutical and the device industry.We included quantitative and qualitative studies addressing any type of interactions between physicians and the industry. We searched MEDLINE and EMBASE in August 2015. Two reviewers independently completed data selection, data extraction and assessment of methodological features. We summarized the findings narratively stratified by type of interaction, outcome and country.Of the 11,902 identified citations, 20 studies met the eligibility criteria. Many studies failed to meet safeguards for protecting from bias. In studies focusing on physicians and the pharmaceutical industry, the percentages of participants reporting awareness was higher for office-use gifts relative to personal gifts. Also, participants were more accepting of educational and office-use gifts compared to personal gifts. The findings were heterogeneous for the perceived effects of physician-industry interactions on prescribing behavior, quality and cost of care. Generally, participants supported physicians' disclosure of interactions through easy-to-read printed documents and verbally. In studies focusing on surgeons and device manufacturers, the majority of patients felt their care would improve or not be affected if surgeons interacted with the device industry. Also, they felt surgeons would make the best choices for their health, regardless of financial relationship with the industry. Participants generally supported regulation of surgeon-industry interactions, preferably through professional rather than governmental bodies.The awareness of participants was low for physicians' receipt of personal gifts. Participants also reported greater acceptability and fewer perceived influence for office-use gifts compared to personal gifts. Overall, there appears to be lower awareness

  7. Knowledge, Beliefs and Attitudes of Patients and the General Public towards the Interactions of Physicians with the Pharmaceutical and the Device Industry: A Systematic Review.

    Science.gov (United States)

    Fadlallah, Racha; Nas, Hala; Naamani, Dana; El-Jardali, Fadi; Hammoura, Ihsan; Al-Khaled, Lina; Brax, Hneine; Kahale, Lara; Akl, Elie A

    2016-01-01

    To systematically review the evidence on the knowledge, beliefs, and attitudes of patients and the general public towards the interactions of physicians with the pharmaceutical and the device industry. We included quantitative and qualitative studies addressing any type of interactions between physicians and the industry. We searched MEDLINE and EMBASE in August 2015. Two reviewers independently completed data selection, data extraction and assessment of methodological features. We summarized the findings narratively stratified by type of interaction, outcome and country. Of the 11,902 identified citations, 20 studies met the eligibility criteria. Many studies failed to meet safeguards for protecting from bias. In studies focusing on physicians and the pharmaceutical industry, the percentages of participants reporting awareness was higher for office-use gifts relative to personal gifts. Also, participants were more accepting of educational and office-use gifts compared to personal gifts. The findings were heterogeneous for the perceived effects of physician-industry interactions on prescribing behavior, quality and cost of care. Generally, participants supported physicians' disclosure of interactions through easy-to-read printed documents and verbally. In studies focusing on surgeons and device manufacturers, the majority of patients felt their care would improve or not be affected if surgeons interacted with the device industry. Also, they felt surgeons would make the best choices for their health, regardless of financial relationship with the industry. Participants generally supported regulation of surgeon-industry interactions, preferably through professional rather than governmental bodies. The awareness of participants was low for physicians' receipt of personal gifts. Participants also reported greater acceptability and fewer perceived influence for office-use gifts compared to personal gifts. Overall, there appears to be lower awareness, less concern and

  8. Pharmaceutical compounds in drinking water

    Directory of Open Access Journals (Sweden)

    Vikas Chander

    2016-06-01

    Full Text Available Pharmaceutical products and their wastes play a major role in the degradation of environment. These drugs have positive as well as negative consequences on different environmental components including biota in different ways. Many types of pharmaceutical substances have been detected with significant concentrations through various advanced instrumental techniques in surface water, subsurface water, ground water, domestic waste water, municipal waste water and industrial effluents. The central as well as state governments in India are providing supports by creating excise duty free zones to promote the pharmaceutical manufacturers for their production. As a result, pharmaceutical companies are producing different types of pharmaceutical products at large scale and also producing complex non-biodegradable toxic wastes byproducts and releasing untreated or partially treated wastes in the environment in absence of strong regulations. These waste pollutants are contaminating all types of drinking water sources. The present paper focuses on water quality pollution by pharmaceutical pollutants, their occurrences, nature, metabolites and their fate in the environment.

  9. A randomized clinical trial of high-dosage coenzyme Q10 in early Parkinson disease: no evidence of benefit.

    Science.gov (United States)

    Beal, M Flint; Oakes, David; Shoulson, Ira; Henchcliffe, Claire; Galpern, Wendy R; Haas, Richard; Juncos, Jorge L; Nutt, John G; Voss, Tiffini Smith; Ravina, Bernard; Shults, Clifford M; Helles, Karen; Snively, Victoria; Lew, Mark F; Griebner, Brian; Watts, Arthur; Gao, Shan; Pourcher, Emmanuelle; Bond, Louisette; Kompoliti, Katie; Agarwal, Pinky; Sia, Cherissa; Jog, Mandar; Cole, Linda; Sultana, Munira; Kurlan, Roger; Richard, Irene; Deeley, Cheryl; Waters, Cheryl H; Figueroa, Angel; Arkun, Ani; Brodsky, Matthew; Ondo, William G; Hunter, Christine B; Jimenez-Shahed, Joohi; Palao, Alicia; Miyasaki, Janis M; So, Julie; Tetrud, James; Reys, Liza; Smith, Katharine; Singer, Carlos; Blenke, Anita; Russell, David S; Cotto, Candace; Friedman, Joseph H; Lannon, Margaret; Zhang, Lin; Drasby, Edward; Kumar, Rajeev; Subramanian, Thyagarajan; Ford, Donna Stuppy; Grimes, David A; Cote, Diane; Conway, Jennifer; Siderowf, Andrew D; Evatt, Marian Leslie; Sommerfeld, Barbara; Lieberman, Abraham N; Okun, Michael S; Rodriguez, Ramon L; Merritt, Stacy; Swartz, Camille Louise; Martin, W R Wayne; King, Pamela; Stover, Natividad; Guthrie, Stephanie; Watts, Ray L; Ahmed, Anwar; Fernandez, Hubert H; Winters, Adrienna; Mari, Zoltan; Dawson, Ted M; Dunlop, Becky; Feigin, Andrew S; Shannon, Barbara; Nirenberg, Melissa Jill; Ogg, Mattson; Ellias, Samuel A; Thomas, Cathi-Ann; Frei, Karen; Bodis-Wollner, Ivan; Glazman, Sofya; Mayer, Thomas; Hauser, Robert A; Pahwa, Rajesh; Langhammer, April; Ranawaya, Ranjit; Derwent, Lorelei; Sethi, Kapil D; Farrow, Buff; Prakash, Rajan; Litvan, Irene; Robinson, Annette; Sahay, Alok; Gartner, Maureen; Hinson, Vanessa K; Markind, Samuel; Pelikan, Melisa; Perlmutter, Joel S; Hartlein, Johanna; Molho, Eric; Evans, Sharon; Adler, Charles H; Duffy, Amy; Lind, Marlene; Elmer, Lawrence; Davis, Kathy; Spears, Julia; Wilson, Stephanie; Leehey, Maureen A; Hermanowicz, Neal; Niswonger, Shari; Shill, Holly A; Obradov, Sanja; Rajput, Alex; Cowper, Marilyn; Lessig, Stephanie; Song, David; Fontaine, Deborah; Zadikoff, Cindy; Williams, Karen; Blindauer, Karen A; Bergholte, Jo; Propsom, Clara Schindler; Stacy, Mark A; Field, Joanne; Mihaila, Dragos; Chilton, Mark; Uc, Ergun Y; Sieren, Jeri; Simon, David K; Kraics, Lauren; Silver, Althea; Boyd, James T; Hamill, Robert W; Ingvoldstad, Christopher; Young, Jennifer; Thomas, Karen; Kostyk, Sandra K; Wojcieszek, Joanne; Pfeiffer, Ronald F; Panisset, Michel; Beland, Monica; Reich, Stephen G; Cines, Michelle; Zappala, Nancy; Rivest, Jean; Zweig, Richard; Lumina, L Pepper; Hilliard, Colette Lynn; Grill, Stephen; Kellermann, Marye; Tuite, Paul; Rolandelli, Susan; Kang, Un Jung; Young, Joan; Rao, Jayaraman; Cook, Maureen M; Severt, Lawrence; Boyar, Karyn

    2014-05-01

    Coenzyme Q10 (CoQ10), an antioxidant that supports mitochondrial function, has been shown in preclinical Parkinson disease (PD) models to reduce the loss of dopamine neurons, and was safe and well tolerated in early-phase human studies. A previous phase II study suggested possible clinical benefit. To examine whether CoQ10 could slow disease progression in early PD. A phase III randomized, placebo-controlled, double-blind clinical trial at 67 North American sites consisting of participants 30 years of age or older who received a diagnosis of PD within 5 years and who had the following inclusion criteria: the presence of a rest tremor, bradykinesia, and rigidity; a modified Hoehn and Yahr stage of 2.5 or less; and no anticipated need for dopaminergic therapy within 3 months. Exclusion criteria included the use of any PD medication within 60 days, the use of any symptomatic PD medication for more than 90 days, atypical or drug-induced parkinsonism, a Unified Parkinson's Disease Rating Scale (UPDRS) rest tremor score of 3 or greater for any limb, a Mini-Mental State Examination score of 25 or less, a history of stroke, the use of certain supplements, and substantial recent exposure to CoQ10. Of 696 participants screened, 78 were found to be ineligible, and 18 declined participation. The remaining 600 participants were randomly assigned to receive placebo, 1200 mg/d of CoQ10, or 2400 mg/d of CoQ10; all participants received 1200 IU/d of vitamin E. Participants were observed for 16 months or until a disability requiring dopaminergic treatment. The prospectively defined primary outcome measure was the change in total UPDRS score (Parts I-III) from baseline to final visit. The study was powered to detect a 3-point difference between an active treatment and placebo. The baseline characteristics of the participants were well balanced, the mean age was 62.5 years, 66% of participants were male, and the mean baseline total UPDRS score was 22.7. A total of 267 participants

  10. The effect of CoQ10 and vitamin E on serum total sialic acid, lipid ...

    African Journals Online (AJOL)

    Administrator

    2011-06-13

    Jun 13, 2011 ... This study was designed to evaluate the effect of CoQ10 and vitamin E on serum total sialic acid (TSA), lipid bound sialic acid (LSA) and some elements in rat administered doxorubicin (DXR). Cu levels were increased in the group treated with DXR + vitamin E in comparison with DXR (p<0.05) and CoQ10 ...

  11. The effect of CoQ 10 and vitamin E on serum total sialic acid, lipid ...

    African Journals Online (AJOL)

    This study was designed to evaluate the effect of CoQ10 and vitamin E on serum total sialic acid (TSA), lipid bound sialic acid (LSA) and some elements in rat administered doxorubicin (DXR). Cu levels were increased in the group treated with DXR + vitamin E in comparison with DXR (p<0.05) and CoQ10 groups (p ...

  12. Supplementing in the diet of lactating Holstein cows may naturally produce coenzyme Q10-enriched milk

    Directory of Open Access Journals (Sweden)

    Gui-Seck Bae

    2018-01-01

    Full Text Available Objective To examine the effects of Rhodobacter sphaeroides (R. sphaeroides supplementation as a direct-fed microbial (DFM on rumen fermentation in dairy cows and on coenzyme Q10 (CoQ10 transition into milk, an in vitro rumen simulation batch culture and an in vivo dairy cow experiment were conducted. Methods The characteristics of in vitro ruminal fermentation were investigated using rumen fluids from six cannulated Holstein dairy cows at 2 h post-afternoon feeding. A control treatment was included in the experiments based on a typified total mixed ration (TMR for lactating dairy cows, which was identical to the one used in the in vivo study, plus R. sphaeroides at 0.1%, 0.3%, and 0.5% TMR dry matter. The in vivo study employed six ruminally cannulated lactating Holstein cows randomly allotted to either the control TMR (C-TMR treatment or to a diet supplemented with a 0.5% R. sphaeroides culture (S-TMR, dry matter basis ad libitum. The presence of R. sphaeroides was verified using denaturing gradient gel electrophoresis (DGGE applied to the bacterial samples obtained from the in vivo study. The concentration of CoQ10 in milk and in the supernatant from the in vitro study was determined using high performance liquid chromatography. Results The results of the in vitro batch culture and DGGE showed that the concentration of CoQ10 significantly increased after 2 h of R. sphaeroides supplementation above 0.1%. When supplemented to the diet of lactating cows at the level of 0.5%, R. sphaeroides did not present any adverse effect on dry matter intake and milk yield. However, the concentration of CoQ10 in milk dramatically increased, with treated cows producing 70.9% more CoQ10 than control cows. Conclusion The CoQ10 concentration in milk increased via the use of a novel DFM, and R. sphaeroides might be used for producing value-added milk and dairy products in the future.

  13. ASEAN GMP and pharmaceutical industries in Indonesia.

    Science.gov (United States)

    Soesilo, S; Sitorus, U

    1995-01-01

    Indonesia was appointed by the ASEAN Technical Cooperation in Pharmaceutical as a focal point and to coordinate the development of practical guidelines for the implementation of GMP. The ASEAN GMP Guidelines were endorsed by the ASEAN Technical Cooperation in Pharmaceutical in 1988, which among others required separation of Beta-Lactam dedicated facilities and three degrees of cleanliness for production areas. As it was realised that drug manufacturers in developing countries need more detailed guidelines to be able to implement the GMP, an Operational Manual for GMP was also prepared for providing examples of SOPs lay-outs, documentation etc. It was agreed by the technical cooperation group to leave the implementation of GMP to each member country. However, the ASEAN Manual for Inspection of GMP was drafted and endorsed by the group and training of ASEAN Drug Inspectors was organized to support the implementation. The ASEAN GMP is being implemented in Indonesia through a five-year, stepwise implementation plan, starting in 1989.

  14. Pharmaceutical policy and the lay public

    DEFF Research Database (Denmark)

    Traulsen, Janine Marie; Almarsdóttir, Anna Birna

    2005-01-01

    Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient organisati......Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient...... organisations, industry and, most recently, the media. Although the overall aim of health and pharmaceutical policy is to address the needs of all citizens, there are only a few, well organised groups who are actually consulted and involved in the policymaking process, often with the support of the industry....... The reasons for this lack of citizen involvement in health and pharmaceutical policymaking are many, for example: there is no consensus about what public involvement means; there is a predominance of special interest groups with narrow, specific agendas; not all decision makers welcome lay participation...

  15. Solar photo-degradation of a pharmaceutical wastewater effluent in a semi-industrial autonomous plant.

    Science.gov (United States)

    Expósito, Antonio J; Durán, Antonio; Monteagudo, José M; Acevedo, Alba

    2016-05-01

    An industrial wastewater effluent coming from a pharmaceutical laboratory has been treated in a semi-industrial autonomous solar compound parabolic collector (CPC) plant. A photo-Fenton process assisted with ferrioxalate has been used. Up to 79% of TOC can be removed in 2 h depending on initial conditions when treating an aqueous effluent containing up to 400 ppm of initial organic carbon concentration (TOC). An initial ratio of Fe(II)/TOC higher than 0.5 guarantees a high removal. It can be seen that most of TOC removal occurs early in the first hour of reaction. After this time, mineralization was very slow, although H2O2 was still present in solution. Indeed it decomposed to form oxygen in inefficient reactions. It is clear that remaining TOC was mainly due to the presence of acetates which are difficult to degrade. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Animals on drugs: understanding the role of pharmaceutical companies in the animal-industrial complex.

    Science.gov (United States)

    Twine, Richard

    2013-12-01

    In this paper I revisit previous critiques that I have made of much, though by no means all, bioethical discourse. These pertain to faithfulness to dualistic ontology, a taken-for-granted normative anthropocentrism, and the exclusion of a consideration of how political economy shapes the conditions for bioethical discourse (Twine Medicine, Health Care and Philosophy 8(3):285-295, 2005; International Journal of Sociology of Agriculture and Food 16(3):1-18, 2007, 2010). Part of my argument around bioethical dualist ontology is to critique the assumption of a division between the "medical" (human) and "agricultural" (nonhuman) and to show various ways in which they are interrelated. I deepen this analysis with a focus on transnational pharmaceutical companies, with specific attention to their role in enhancing agricultural production through animal drug administration. I employ the topical case of antibiotics in order to speak to current debates in not only the interdisciplinary field of bioethics but also that of animal studies. More generally, the animal-industrial complex (Twine Journal for Critical Animal Studies 10(1):12-39, 2012) is underlined as a highly relevant bioethical object that deserves more conceptual and empirical attention.

  17. Antiatherogenic, hepatoprotective, and hypolipidemic effects of coenzyme Q10 in alloxan-induced type 1 diabetic rats

    Directory of Open Access Journals (Sweden)

    Hassan Ahmadvand

    2014-07-01

    Full Text Available BACKGROUND: Diabetes mellitus, one of the leading metabolic syndromes, accounts for highest morbidity and mortality worldwide. In this study, we examined possible protective effect of coenzyme Q10 on lipid profile, atherogenic index, and liver enzyme markers in alloxan-induced type 1 diabetic rats. METHODS: A total of 30 male rats were randomly divided into three groups; group 1 as control, group 2 diabetic untreatment, and group 3 treatments with coenzyme Q10 by 15 mg/kg i.p. daily, respectively .Diabetes was induced in the second and third groups by alloxan injection subcutaneously. After 8 weeks, the levels of fasting blood glucose (FBG, triglyceride (TG, total cholesterol (TC, low density lipoprotein (LDL, very low-density lipoprotein (VLDL, high density lipoprotein (HDL, atherogenic index, atherogenic coefficient, cardiac risk ratio, and the activities of alanine aminotransferase (ALT, aspartate aminotransferase (AST, and alkaline phosphatase (ALP of all groups were analyzed. Data were analyzed using non-parametric Mann-Whitney test (using SPSS and P < 0.05 was considered as significant. RESULTS: Coenzyme Q10 inhibited significantly the activities of ALT (11.17%, AST (19.35% and ALP (36.67% and decreased FBG (21.19%, TG (37.24%, TC (17.15%, LDL (30.44%, VLDL (37.24%, atherogenic index (44.24%, atherogenic coefficient (49.69%, and cardiac risk ratio (37.97%, HDL level was significantly (33.38% increased when treated with coenzyme Q10. CONCLUSION: The findings of this study suggest that coenzyme Q10 exert beneficial effects on the lipid profile, atherogenic index, and liver enzymes activity in alloxan-induced type 1 diabetic rats.   Keywords: Diabetes, Lipid Profile, Atherogenic Index, Rats, Liver Enzymes, Coenzyme Q10 

  18. [PICS: pharmaceutical inspection cooperation scheme].

    Science.gov (United States)

    Morénas, J

    2009-01-01

    The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry.

  19. Pharmaceutical strategy and innovation: an academics perspective.

    Science.gov (United States)

    Baxendale, Ian R; Hayward, John J; Ley, Steven V; Tranmer, Geoffrey K

    2007-06-01

    The pharmaceutical industry is under increasing pressure on many fronts, from investors requiring larger returns to consumer groups and health authorities demanding cheaper and safer drugs. It is also feeling additional pressure from the infringement upon its profit margins by generic drug producers. Many companies are aggressively pursuing outsourcing contracts in an attempt to counter many of the financial pressures and streamline their operations. At the same time, the productivity of the pharmaceutical industry at its science base is being questioned in terms of the number of products and the timeframes required for each company to deliver them to market. This has generated uncertainties regarding the current corporate strategies that have been adopted and the levels of innovation being demonstrated. In this essay we discuss these topics in the context of the global pharmaceutical market, investigating the basis for many of these issues and highlighting the hurdles the industry needs to overcome, especially as they relate to the chemical sciences.

  20. High serum coenzyme Q10, positively correlated with age, selenium and cholesterol in Inuit of Greenland

    DEFF Research Database (Denmark)

    Pedersen, Henning Sloth; Mortensen, S.A.; Rhode, M.

    1999-01-01

    impact. From a health survey we chose the subpopulation from the most remote area, where the traditional Greenlandic diet with high intake of sea mammals and fish predominates. The mean (SD) of S-CoQ10 in males was 1.495 (0.529) nmol/ml and 1.421 (0.629) nmol/ml in females, significantly higher (p ....001) compared to a Danish population. In a linear multiple regression model the S-CoQ10 level is significantly positively associated with age and S-selenium in males, and S-total cholesterol in females. The high level of CoQ10 in Greenlanders probably reflects diet, since no bioaccumulation takes place...

  1. Antioxidant vitamins C, E and coenzyme Q10 vs Dexamethasone: comparisons of their effects in pulmonary contusion model

    Directory of Open Access Journals (Sweden)

    Gokce Mertol

    2012-09-01

    Full Text Available Abstract Background The goal of our study is to evaluate the effects of antioxidant vitamins (vitamin C and E, Coenzyme Q10 (CoQ10 and dexamethasone (Dxm in experimental rat models with pulmonary contusion (PC. Methods Rats were randomly divided into six groups. Except for the control, all subgroups had a moderate pulmonary contusion. Animals in the group I and group II received intraperitoneal saline, group III received 10mg.kg-1 CoQ10 group IV received 100mg.kg-1 vitamin C, group V received 150mg.kg-1 vitamin E, and group VI received 10mg.kg-1 Dxm. Blood gas analysis, serum nitric oxide (NO and malondialdehyde (MDA levels as well as superoxide dismutase (SOD activity assays, bronchoalveolar lavage (BAL fluid and histopathological examination were performed. Results Administration of CoQ10 resulted in a significant increase in PaO2 values compared with the group I (p = 0.004. Levels of plasma MDA in group II were significantly higher than those in the group I (p = 0.01. Early administration of vitamin C, CoQ10, and Dxm significantly decreased the levels of MDA (p = 0.01. Lung contusion due to blunt trauma significantly decreased SOD activities in rat lung tissue compared with group I (p = 0.01. SOD levels were significantly elevated in animals treated with CoQ10, Vitamin E, or Dxm compared with group II (p = 0.01. Conclusions In our study, CoQ10, vitamin C, vitamin E and Dxm had a protective effect on the biochemical and histopathological outcome of PC after experimental blunt thorax trauma.

  2. Effect of cooking and in vitro digestion on the stability of co-enzyme Q10 in processed meat products.

    Science.gov (United States)

    Tobin, Brian D; O'Sullivan, Maurice G; Hamill, Ruth; Kerry, Joseph P

    2014-05-01

    The use of CoQ10 fortification in the production of a functional food has been demonstrated in the past but primarily for dairy products. This study aimed to determine the bio-accessibility of CoQ10 in processed meat products, beef patties and pork breakfast sausages, fortified with CoQ10. Both the patties and sausages were fortified with a micellarized form of CoQ10 to enhance solubility to a concentration of 1mg/g of sample (NovaSolQ®). An assay was developed combining in vitro digestion and HPLC analysis to quantify the CoQ10 present in fortified products (100mg/g). The cooking retention level of CoQ10 in the products was found to be 74±1.42% for patties and 79.69±0.75% for sausages. The digestibility for both products ranged between 93% and 95%, sausages did have a higher digestibility level than patties but this was not found to be significant (P<0.01). Copyright © 2013 Elsevier Ltd. All rights reserved.

  3. Medications development for substance-use disorders: contextual influences (dis)incentivizing pharmaceutical-industry positioning.

    Science.gov (United States)

    Janero, David R

    2014-11-01

    The significant contribution of substance-use disorders (SUDs) to the global-disease burden and associated unmet medical needs has not engendered a commensurate level of pharma-industry research and development (R&D) for novel SUD therapeutics invention. Analysis of contextual factors shaping this position suggests potential routes toward incentivizing R&D commitment for that purpose. This article considers multiple primary factors that have consorted to disincentivize pharma industry's operating in the SUD space: ill-understood pathology; variegated treatments and patient profiles; involved clinical trials; and - with particular reference to SUDs-negative cultural/business stigmas and shallow commercial precedent. Industry incentivization for SUD drug innovation requires progress on several fronts, including: translational experimental data and systems; personalized, holistic SUD treatment approaches; interactions among pharma, nonindustry constituencies, and the medical profession with vested interests in countering negative stereotypes and expanding SUD treatment options; and public-private alliances focused on improving SUD pharmacotherapy. Given the well-entrenched business stance whereby the prospect of future profits in major markets largely determines drug-company R&D investment trajectory, strategic initiatives offering substantial reductions in the risks and opportunity (i.e., time and money) costs associated with SUD drug discovery are likely to be the most potent drivers for encouraging mainstream industry positioning in this therapeutic area. Such initiatives could originate from front-loaded R&D operational and back-loaded patent, regulatory, marketing and health-care policy reforms. These may be too involved and protracted for the turbulent pharmaceutical industry to entertain amid its recent retrenchment from psychiatric/CNS diseases and intense pressures to increase productivity and shareholder value.

  4. Keeping modern in medicine: pharmaceutical promotion and physician education in postwar America.

    Science.gov (United States)

    Greene, Jeremy A; Podolsky, Scott H

    2009-01-01

    Recent critiques of the role of pharmaceutical promotion in medical practice invoke a nostalgic version of 1950s and 1960s medicine as representing an uncomplicated relationship between an innovative pharmaceutical industry and an idealistic and sovereign medical profession-a relationship that was later corrupted by regulatory or business practice changes in the 1980s or 1990s. However, the escalation of innovation and promotion in the pharmaceutical industry at mid-century had already provoked a broader crisis of overflow in medical education in which physicians came to use both commercial and professional sources in an attempt to "keep modern" by incorporating emerging therapeutics into their practices. This phenomenon was simultaneously a crisis for the medical profession- playing a key role in attempts to inculcate a "rational therapeutics"-and a marketing opportunity for the pharmaceutical industry, and produced the structural foundations for contemporary debates regarding the role of pharmaceutical promotion in medical practice. Tracing the issue from the advent of the wonder drugs through today's concerns regarding formal CME, we document how and why the pharmaceutical industry was allowed (and even encouraged) to develop and maintain the central role it now plays within postgraduate medical education and prescribing practice.

  5. Gateway to the Future. Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories.

    Science.gov (United States)

    Education Development Center, Inc., Newton, MA.

    The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceutical companies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…

  6. MANAGING INDUSTRIAL PHARMACEUTICAL RESEARCH-AND-DEVELOPMENT - A COMPARATIVE-STUDY OF MANAGEMENT CONTROL AND INNOVATIVE EFFECTIVENESS IN EUROPEAN AND ANGLO-AMERICAN COMPANIES

    NARCIS (Netherlands)

    OMTA, SWF; BOUTER, LM; VANENGELEN, JML

    1994-01-01

    Drug regulation and pricing have put strong pressure on the cost-benefit ratio of the innovative pharmaceutical industry. Therefore a study has been conducted in fourteen large and medium sized companies to determine some important organisational and managerial factors influencing success in

  7. Molecular rational for riboflavin and CoQ10

    DEFF Research Database (Denmark)

    Cornelius, Nanna

    2013-01-01

    A new PhD project from Health, Aarhus University, shows that there is a molecular rationale for riboflavin and CoQ10 treatment in patients with Riboflavin Responsive Multiple acyl-CoA dehydrogenation deficiency. The project was carried out by Nanna Cornelius, a molecular biologist who defended her......-QO) protein. High dosis Riboflavin treatment nearly normalizes the clinical and biochemical symptoms of these patients. Until now, no studies have investigated the molecular effect of riboflavin in the patients. However, in her recently completed PhD project, Nanna Cornelius shows that riboflavin has...

  8. Inherent Anticipation in the Pharmaceutical and Biotechnology Industries.

    Science.gov (United States)

    Goldman, Michael; Evans, Georgia; Zappia, Andrew

    2015-04-15

    Pharmaceutical and biotech research often involves discovering new properties of, or new methods to use, existing compositions. The doctrine of inherent anticipation, however, prevents the issuance and/or validity of a patent for discoveries deemed to have been implicitly disclosed in the prior art. This can be a barrier to patent rights in these technologies. Inherent anticipation therefore creates uncertainty for patent protection in the pharmaceutical and biotech sciences. Despite this uncertainty, Federal Circuit jurisprudence provides guidance on the boundaries of the inherent anticipation doctrine. In view of the case law, certain strategies may be employed to protect inventions that may potentially be viewed as inherent in the prior art. Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.

  9. The effect of coenzyme Q10 included by γ-cyclodextrin on the growth of fission yeast studied by microscope Raman spectroscopy

    Science.gov (United States)

    Nishida, Tatsuro; Kaino, Tomohiro; Ikarashi, Ryo; Nakata, Daisuke; Terao, Keiji; Ando, Masahiro; Hamaguchi, Hiro-o.; Kawamukai, Makoto; Yamamoto, Tatsuyuki

    2013-09-01

    The inclusion complex of coenzyme Q10 (CoQ10) by γ-cyclodextrin (γ-CD), CoQ10-CD complex, was recently developed. The addition of the CoQ10-CD complex recovered the growth of a fission yeast mutant strain, Δdps1, which otherwise cannot grow well due to the lack of coenzyme Q producing ability. However, the oxygen consumption rate of this strain was not restored by the addition of the CoQ10-CD complex. The addition of two other anti-oxidative reagents, glutathione and ascorbic acid, also recovered the growth of the Δdps1 strain as well. These results indicated that the recovery of the growth of Δdps1 was brought about by the anti-oxidative property of CoQ10. The intensity of Raman spectra of Δdps1 at 1602 cm-1, which is prominently observed for the wild type of the fission yeast, was compared between before and after addition of the CoQ10-CD complex. The signal was very weakly observed for Δdps1 and did not increase in intensity by the addition of the CoQ10-CD complex. These results suggested the recovery of the growth of Δdps1 was brought about not by the restoration of respiration function of Δdps1 but by the anti-oxidative property of CoQ10 to result in the decrease in the oxidative stress.

  10. Reconsidering Japan's underperformance in pharmaceuticals: evidence from Japan's anticancer drug sector.

    Science.gov (United States)

    Umemura, Maki

    2010-01-01

    Unlike its automobile or electronics industries, Japan's pharmaceutical industry did not become a global leader. Japan remains a net importer of pharmaceuticals and has introduced few global blockbuster drugs. Alfred Chandler argued that Japan's pharmaceutical firms remained relatively weak because Western firms enjoyed an insurmountable first first-mover advantage. However, this case study of the anticancer drug sector illustrates that Chandler's explanation is incomplete. Japanese medical culture, government policy, and research environment also played a substantial role in shaping the industry. In the 1970s and 1980s, these factors encouraged firms to develop little few effective drugs with low side effects, and profit from Japan's domestic market. But, these drugs were unsuitable to foreign markets with more demanding efficacy standards. As a result, Japan not only lost more than a decade in developing ineffective drugs, but also neglected to create the infrastructure necessary to develop innovative drugs and build a stronger pharmaceutical industry.

  11. The role of the pharmaceutical industry in meeting the public health threat of antibacterial resistance.

    Science.gov (United States)

    Bergström, Richard

    2011-04-01

    The established market model for pharmaceutical products, as for most other products, is heavily dependent on sales volumes. Thus, it is a primary interest of the producer to sell large quantities. This may be questionable for medicinal products and probably most questionable for antibacterial remedies. For these products, treatment indications are very complex and encompass both potential patient benefits, possible adverse effects in the actual patient and, which is unique for this therapeutic class, consideration about what effects the drug use will have on the future therapeutic value of the drug. This is because bacteria are sure to develop resistance. The European Federation of Pharmaceutical Industries and Associations (EFPIA) agrees with the general description of the antibacterial resistance problem and wants to participate in measures to counteract antibacterial resistance. Stakeholders should forge an alliance that will address the need for and prudent use of new antibiotics. A variety of incentives probably have to be applied, but having all in common that the financial return has to be separated from the use of the product. Copyright © 2011. Published by Elsevier Ltd.

  12. Drivers of peak sales for pharmaceutical brands

    NARCIS (Netherlands)

    Fischer, Marc; Leeflang, Peter S. H.; Verhoef, Peter C.

    2010-01-01

    Peak sales are an important metric in the pharmaceutical industry. Specifically, managers are focused on the height-of-peak-sales and the time required achieving peak sales. We analyze how order of entry and quality affect the level of peak sales and the time-to-peak-sales of pharmaceutical brands.

  13. Protective effect of coenzyme Q10 in simvastatin and gemfibrozil induced rhabdomyolysis in rats.

    Science.gov (United States)

    Farswan, Mamta; Rathod, S P; Upaganlawar, A B; Semwal, Arvind

    2005-10-01

    Administration of simvastatin (80 mg/kg, po. evening dose) and gemfibrozil (600 mg/kg, po twice) for 30 days produced significant decrease in the level of reduced glutathione, superoxide dismutase, catalase and increase in the level of lipid peroxidation and various serum parameters (creatine phosphokinase, lactate dehydrogenase, serum glutamate oxaloacetate transaminase, creatinine, urea and blood urea nitrogen). This suggested involvement of oxidative stress in rhabdomyolysis. Increase in the level of reduced glutathione, superoxide dismutase, catalase and decrease in the level of lipid peroxidation and serum parameters after administration of antioxidant CoQ10 (10 mg/kg.ip) proved the protective effect of CoQ10 in rhabdomyolysis.

  14. Effects of ubiquinone (coenzyme Q10) on myopathy in statin users.

    NARCIS (Netherlands)

    Schaars, C.F.; Stalenhoef, A.F.H.

    2008-01-01

    PURPOSE OF REVIEW: Statins are associated with muscle complaints, including myositis. The mechanism through which statin use causes muscle toxicity is unknown. One of the theories is that statin therapy reduces coenzyme Q10 levels in muscle mitochondria, which leads to muscle injury and myopathy.

  15. The Applied Aspects of Transposition and Integration of Development Resources in the System of Strategic Management of the Pharmaceutical Industry Enterprises

    Directory of Open Access Journals (Sweden)

    Mykhailiuk Myroslava О.

    2018-02-01

    Full Text Available The article is aimed at researching the transposition and integration of development resources in the system of strategic management of pharmaceutical enterprises. It has been determined that in the current of market functioning, resources are transformed into development resources. The proposed scheme of transposition and integration of development resources in the system of strategic management of enterprises provides a combination of resource opportunities of company with market conditions and reflects synergistic interaction between two classical theories of strategic management: the M. Porter’s sectoral competition theory and the resource theory. The basic priorities of development of the pharmaceutical industry in the contemporary market environment are defined and trends of activity of pharmaceutical companies are indicated. Enterprises are distributed according to the criterion of introduction of development resources strategy, measures on increase of efficiency of their activity are suggested.

  16. A randomized controlled trial of coenzyme Q10 for fatigue in the late-onset sequelae of poliomyelitis.

    Science.gov (United States)

    Peel, Margaret M; Cooke, Marie; Lewis-Peel, Helen J; Lea, Rodney A; Moyle, Wendy

    2015-12-01

    To determine if coenzyme Q(10) alleviates fatigue in the late-onset sequelae of poliomyelitis. Parallel-group, randomized, placebo-controlled trial. Coenzyme Q(10) has been shown to boost muscle energy metabolism in post-polio subjects but it does not promote muscle strength, endurance or function in polio survivors with post-poliomyelitis syndrome. However, the collective increased energy metabolism might contribute to a reduction in post-polio fatigue. Polio survivors from the Australian post-polio networks in Queensland and New South Wales who attribute a moderate to high level of fatigue to their diagnosed late-onset sequelae of poliomyelitis. Those with fatigue-associated comorbidities of diabetes, anaemia, hypothyroidism and fibromyalgia were excluded. Participants were assigned (1:1), with stratification of those who use energy-saving mobility aids, to receive 100 mg coenzyme Q(10) or matching placebo daily for 60 days. Participants and investigators were blinded to group allocation. Fatigue was assessed by the Multidimensional Assessment of Fatigue as the primary outcome and the Fatigue Severity Scale as secondary outcome. Of 103 participants, 54 were assigned to receive coenzyme Q(10) and 49 to receive the placebo. The difference in the mean score reductions between the two groups was not statistically significant for either fatigue measure. Oral supplementation with coenzyme Q(10) was safe and well-tolerated. A daily dose of 100 mg coenzyme Q(10) for 60 days does not alleviate the fatigue of the late-onset sequelae of poliomyelitis. The registration number for the clinical trial is ACTRN 12612000552886. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Modelling of drying processes of pharmaceutical granules. Pharmaceutical Sciences for the Future of Medicines

    DEFF Research Database (Denmark)

    Mortier, S.T.F.C.; Vedantam, S.; De Beer, T.

    Tablets are conventionally produced via consecutive batch process steps. Recent introduction of continuous process equipment is gaining industrial importance in pharmaceutics. Transition to continuous production requires improved understanding of all operations, necessitating the development...... of mechanistic models of multi‐phase systems which in the end allow process control. This contribution focuses on continuous fluidized bed drying of pharmaceutical wet granules. A stepwise approach is used in model development, starting with the drying behaviour of single granules. Experiments to determine...

  18. Pharmaceutical Public-Private Partnerships

    DEFF Research Database (Denmark)

    Bagley, Constance; Tvarnø, Christina D.

    2014-01-01

    This article provides a game theory and law-and-management analysis of for- profit pharmaceutical public-private partnerships, a complex type of legal arrangement in the highly regulated pharmaceutical industry. A pharmaceutical public-private partnership (PPPP) agreement is a legally binding...... and a practical perspective on how properly crafted PPPP arrangements can promote innovation more efficiently than traditional self-optimizing contracts. In particular, a properly framed binding contract, coupled with respect for positive incentives, can move the parties away from an inefficient prisoners...... systems to build and share innovation. When coupled with appropriate attention to the difficult task of coordinating the actions of interdependent actors, a PPPP arrangement can enhance the likelihood of successful commercialization of pharmacological discoveries by flipping the par- ties’ incentives...

  19. Computational Chemistry in the Pharmaceutical Industry: From Childhood to Adolescence.

    Science.gov (United States)

    Hillisch, Alexander; Heinrich, Nikolaus; Wild, Hanno

    2015-12-01

    Computational chemistry within the pharmaceutical industry has grown into a field that proactively contributes to many aspects of drug design, including target selection and lead identification and optimization. While methodological advancements have been key to this development, organizational developments have been crucial to our success as well. In particular, the interaction between computational and medicinal chemistry and the integration of computational chemistry into the entire drug discovery process have been invaluable. Over the past ten years we have shaped and developed a highly efficient computational chemistry group for small-molecule drug discovery at Bayer HealthCare that has significantly impacted the clinical development pipeline. In this article we describe the setup and tasks of the computational group and discuss external collaborations. We explain what we have found to be the most valuable and productive methods and discuss future directions for computational chemistry method development. We share this information with the hope of igniting interesting discussions around this topic. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  20. Exogenous coenzyme Q10 modulates MMP-2 activity in MCF-7 cell line as a breast cancer cellular model

    Directory of Open Access Journals (Sweden)

    Mirmiranpour Hossein

    2010-11-01

    Full Text Available Abstract Background/Aims Matrix Metalloproteinases 2 is a key molecule in cellular invasion and metastasis. Mitochondrial ROS has been established as a mediator of MMP activity. Coenzyme Q10 contributes to intracellular ROS regulation. Coenzyme Q10 beneficial effects on cancer are still in controversy but there are indications of Coenzyme Q10 complementing effect on tamoxifen receiving breast cancer patients. Methods In this study we aimed to investigate the correlation of the effects of co-incubation of coenzyme Q10 and N-acetyl-L-cysteine (NAC on intracellular H2O2 content and Matrix Metalloproteinase 2 (MMP-2 activity in MCF-7 cell line. Results and Discussion Our experiment was designed to assess the effect in a time and dose related manner. Gelatin zymography and Flowcytometric measurement of H2O2 by 2'7',-dichlorofluorescin-diacetate probe were employed. The results showed that both coenzyme Q10 and N-acetyl-L-cysteine reduce MMP-2 activity along with the pro-oxidant capacity of the MCF-7 cell in a dose proportionate manner. Conclusions Collectively, the present study highlights the significance of Coenzyme Q10 effect on the cell invasion/metastasis effecter molecules.

  1. Rosuvastatin lowers coenzyme Q10 levels, but not mitochondrial adenosine triphosphate synthesis, in children with familial hypercholesterolemia

    NARCIS (Netherlands)

    Avis, Hans J.; Hargreaves, Ian P.; Ruiter, Jos P. N.; Land, John M.; Wanders, Ronald J.; Wijburg, Frits A.

    2011-01-01

    To investigate whether statin therapy affects coenzyme Q10 (CoQ10) status in children with heterozygous familial hypercholesterolemia (FH). Samples were obtained at baseline (treatment naïve) and after dose titration with rosuvastatin, aiming for a low-density lipoprotein cholesterol level of 110

  2. Significance of Ubiad1 for Epidermal Keratinocytes Involves More Than CoQ10 Synthesis: Implications for Skin Aging

    Directory of Open Access Journals (Sweden)

    Florian Labarrade

    2018-01-01

    Full Text Available The significance of Coenzyme Q10 (CoQ10 as an anti-oxidant barrier of the skin, as well as a key component in anti-aging strategies for skin care products, has been firmly established. Biosynthesis of CoQ10 in the mitochondria is well known, but there is only limited information on the non-mitochondrial synthesis of CoQ10 in the skin. Recent findings in zebrafish identified that a tumor suppressor, Ubiad1, is also a key enzyme in the non-mitochondrial synthesis of CoQ10. The purpose of this study was to investigate expression of Ubiad1 in human skin, and its implication in the skin’s cutaneous response to oxidative stress. We observed Ubiad1 localization in the epidermis, particularly a subcellular localization in the Golgi apparatus. Ubiad1 modulation by a pentapeptide was associated with an observed reduction in ROS/RNS stresses (−44%/−19% respectively, lipid peroxidation (−25% and preservation of membrane fluidity under stress conditions. Electron microscopy of keratinocytes revealed a significant degree of stimulation of the Golgi complex, as well as significantly improved mitochondrial morphology. Given the importance of CoQ10 in mitigating the visible signs of skin aging, our findings identify Ubiad1 as an essential component of the defensive barriers of the epidermis.

  3. Phenotypic variability in Waardenburg syndrome resulting from a 22q12.3-q13.1 microdeletion involving SOX10.

    Science.gov (United States)

    Jelena, Brezo; Christina, Lam; Eric, Vilain; Fabiola, Quintero-Rivera

    2014-06-01

    Waardenburg syndrome (WS) is a neurocristopathy characterized by pigmentation abnormalities of the skin, hair, and iris, as well as sensorineural hearing loss. Contiguous gene deletions encompassing SOX10 are rare, which limits conclusions about genotype-phenotype correlation regarding patient prognosis and management. This study adds to the existing body of knowledge by characterizing a 2.4 Mb deletion [arr[hg19] 22q12.3-q13.1 (36467502-38878207)x1] encompassing SOX10 and 53 additional RefSeq genes in a 15-year-old female with atypical WS. The patient presented with developmental delay, profound bilateral sensorineural hearing loss, heterochromia iridis, hypotonia, and bilateral finger contractures. Published genomic and phenotypic profiles of patients with SOX10-encompassing deletions point toward several plausible candidate gene that could account for the considerable clinical heterogeneity. These studies suggest the existence of modifiers among the co-deleted, dosage-sensitive genes (e.g., MYH9) and among genes whose effect may depend on the unmasking of recessive mutations (e.g., PLA2G6). Finally, we highlight evidence illustrating extensive interconnectivity of SOX10-hypothesizing that haploinsufficiency of SOX10 may "unmask" subtler effects on expression or epistasis associated with variants in SOX10 targets (e.g., DHH), in its partners (e.g., PAX3, EGR2), and in genes with functional overlap (e.g., SOX8, SOX9). © 2014 Wiley Periodicals, Inc.

  4. Pharmacist-industry relationships.

    Science.gov (United States)

    Saavedra, Keene; O'Connor, Bonnie; Fugh-Berman, Adriane

    2017-12-01

    The purpose of this study was to document, in their own words, beliefs and attitudes that American pharmacists have towards the pharmaceutical industry and pharmacists' interactions with industry. An ethnographic-style qualitative study was conducted utilizing open-ended interviews with four hospital pharmacists, two independent pharmacists, two retail pharmacists and one administrative pharmacist in the Washington, DC, metropolitan area to elicit descriptions of and attitudes towards pharmacists' relationships with industry. Analysis of the qualitative material followed established ethnographic conventions of narrative thematic analysis. All pharmacists reported interactions with pharmaceutical company representatives. Most had received free resources or services from industry, including educational courses. Respondents uniformly believed that industry promotional efforts are primarily directed towards physicians. Although respondents felt strongly that drug prices were excessive and that 'me-too' drugs were of limited use, they generally had a neutral-to-positive view of industry-funded adherence/compliance programmes, coupons, vouchers, and copay payment programmes. Interviewees viewed direct-to-consumer advertising negatively, but had a generally positive view of industry-funded drug information. Pharmacists may represent a hitherto under-identified cohort of health professionals who are targeted for industry influence; expanding roles for pharmacists may make them even more attractive targets for future industry attention. Pharmacy schools should ensure that students learn to rely on unbiased information sources and should teach students about conflicts of interest and the risks of interacting with industry. Further research should be conducted on the extent to which pharmacists' attitudes towards their duties and towards drug assessment and recommendation are influenced by the pharmaceutical industry. © 2017 Royal Pharmaceutical Society.

  5. Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

    Energy Technology Data Exchange (ETDEWEB)

    Razem, D; Katusin-Razem, B [Institut Rudjer Boskovic, Zagreb (Yugoslavia); Starcevic, M; Galekovic, B [PLIVA Pharmaceutical Works, Zagreb (Yugoslavia)

    1990-01-01

    The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author).

  6. Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

    International Nuclear Information System (INIS)

    Razem, D.; Katusin-Razem, B.; Starcevic, M.; Galekovic, B.

    1990-01-01

    The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author)

  7. Respecting the right to access to medicines: Implications of the UN Guiding Principles on Business and Human Rights for the pharmaceutical industry.

    Science.gov (United States)

    Moon, Suerie

    2013-06-14

    What are the human rights responsibilities of pharmaceutical companies with regard to access to medicines? The state-based international human rights framework has long struggled with the issue of the human rights obligations of non-state actors, a question sharpened by economic globalization and the concomitant growing power of private for-profit actors ("business"). In 2011, after a six-year development process, the UN Human Rights Council unanimously endorsed the Guiding Principles advanced by the UN Secretary General's Special Representative on Business and Human Rights, John Ruggie. The Ruggie Principles sought to clarify and differentiate the responsibilities of states and non-state actors-in this case, "business" -with respect to human rights. The framework centered on "three core principles: the state duty to protect against human rights abuses by third parties, including business; the corporate responsibility to respect human rights; and the need for more effective access to remedies." The "Protect, Respect, and Remedy" Framework emerged from a review of many industrial sectors operating from local to global scales, in many regions of the world, and involving multiple stakeholder consultations. However, their implications for the pharmaceutical industry regarding access to medicines remain unclear. This article analyzes the 2008 Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines advanced by then-UN Special Rapporteur on the Right to Health, Paul Hunt, in light of the Ruggie Principles. It concludes that some guidelines relate directly to the industry's responsibility to respect the right to access to medicines, and form a normative baseline to which firms should be held accountable. It also finds that responsibility for other guidelines may better be ascribed to states than to private actors, based on conceptual and practical considerations. While not discouraging the pharmaceutical industry from making additional

  8. Silo effect a prominence factor to decrease efficiency of pharmaceutical industry.

    Science.gov (United States)

    Vatanpour, Hossein; Khorramnia, Atoosa; Forutan, Naghmeh

    2013-01-01

    To be sure, all the industries try to be involved in globalization with a constant trend to find out ways to increase productivity across different functions within an organization to maintain competitive advantage world. Pharmaceutical industries are not exceptional and further are based on fragmentation. So these kind of companies need to cope with several barriers such as silo mentality that may affect efficiency of their business activity. Due to eliminate a part of resources such as raw materials, new molecule developed, financial and human resources and so on, companies can gradually loss their competitive potentials in the market and increase their expenses. Furthermore, to avoid any business disturbances in financially connected companies due to silo effect, they should arrange their management to integrated organization form. Otherwise, actions taken by one business member of the chain can influence the profitability of all the other members in the chain. That is why recently supply chain has generated much interest in many business units. In this paper, it has been tried to investigate the different aspects of silo effect which can affect integrate supply chain. Finally, a fluent communication, high level of information exchange, fragmentation management, cross-functional control in a supply chain management format are needed to reduce or control silo effect within entire chain of the holding company by Supply chain management.

  9. Health risks of counterfeit pharmaceuticals.

    Science.gov (United States)

    ten Ham, Martijn

    2003-01-01

    Pharmaceutical products are not exempt from the practice of counterfeiting. In recent years, many reports have become available demonstrating the presence of fake medicines on the market. Several studies have demonstrated that they are quite often of bad quality. It is estimated that 5% of all world trade in branded goods is counterfeit, leading to huge financial losses for the pharmaceutical industry. But much more important, from a public health point of view, is that history has shown that such products may lead to a great health risk. The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product. The existence of counterfeit drugs has long been ignored both by the pharmaceutical industry and by drug regulatory authorities. At present initiatives are being taken, nationally and internationally, to curb counterfeiting. It is now realised that a strong regulatory agency is essential, but the initiatives can only be successful if all parties concerned actively co-operate.

  10. Desafios da química analítica frente às necessidades da indústria farmacêutica Challenges of analytical chemistry in face of the needs of the pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Alberto dos Santos Pereira

    2005-12-01

    Full Text Available The development of liquid chromatography-mass spectrometric (LC-MS techniques in the last few decades has made possible the analysis of trace amounts of analytes from complex matrices. With LC, the analytes of interest can be separated from each other as well as from the interfering matrix, after which they can be reliably identified thanks to the sensitivity and specificity of MS. LC-MS has become an irreplaceable tool for many applications, ranging from the analysis of proteins or pharmaceuticals in biological fluids to the analysis of toxic substances in environmental samples. In different segments of Brazilian Industry mass spectrometry has an important role, e.g. in the pharmaceutical industry in the development of generic formulations, contributing to the growth of Industry and social inclusion. However, the Brazilian chemists until this moment don't have an effective role in this new segment of the analytical chemistry in Brazil. The present paper shows the actual scenario for mass spectrometry in the pharmaceutical industry, emphasizing the need of a revision of graduation courses to attend the needs of this growing market.

  11. Integrating systems Approaches into Pharmaceutical Sciences

    DEFF Research Database (Denmark)

    Westerhoff, H.V.; Mosekilde, Erik; Noe, C. R.

    2008-01-01

    During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and BioSim, the major European Network of Excellence on Systems Biology, held a challenging conference on the use of mathematical models in the drug development process. More precisely, the purpose...... of the conference was to promote the ‘Integration of Systems Approaches into Pharmaceutical Sciences’ in view of optimising the development of new effective drugs. And a challenge this is, considering both the high attrition rates in the pharmaceutical industry and the failure of finding definitive drug solutions...... for many of the diseases that plague mankind today. The conference was co-sponsored by the American College of Clinical Pharmacology, the European Center for Pharmaceutical Medicine, and the Swiss Society of Pharmaceutical Sciences and, besides representatives from the European Regulatory Agencies and FDA...

  12. Elimination of micropollutants and hazardous substances at the source in the chemical and pharmaceutical industry.

    Science.gov (United States)

    Blöcher, C

    2007-01-01

    Industrial wastewater, especially from chemical and pharmaceutical production, often contains substances that need to be eliminated before being discharged into a biological treatment plant and following water bodies. This can be done within the production itself, in selected waste water streams or in a central treatment plant. Each of these approaches has certain advantages and disadvantages. Furthermore, a variety of wastewater treatment processes exist that can be applied at each stage, making it a challenging task to choose the best one in economic and ecological terms. In this work a general approach for that and examples from practice are discussed.

  13. Determining supply chain management trends in the pharmaceutical industry / Mokgokong ElizabethTsoku

    OpenAIRE

    Tsoku, Mokgokong Elizabeth

    2014-01-01

    For quality service, business management is continually evolving. This also applies to pharmaceutical business management from manufacturing to distribution and retail pharmacies. The main problem being faced is to work on the demand and supply challenges that are being faced by the pharmaceutical businesses and to build and optimize supply chain management in pharmaceutical business in South Africa. The main objective of this study sets to evaluate whether supply chain tren...

  14. Supply Network Planning for New Product Market Entry in the Pharmaceutical Industry

    DEFF Research Database (Denmark)

    Hansen, Klaus Reinholdt Nyhuus; Grunow, Martin

    2011-01-01

    uncertainty and the risk of a forced label change and includes solution robustness. While considering limited shelf life of the drug, the supply of packaging material and outsourcing, the objective of our model is to reduce supply chain cost including lost peak sales from delayed market entry....... planning before and during the market entry of the drug after the drug has been approved. Production of the active pharmaceutical ingredient [API] is characterized by long change-over times due to cleaning requirements. Production planning is long term, multiple batches of each drug are produced...... industry, reimbursement negotiations have to be carried out before a drug can be marketed. These negotiations both necessitate time phasing market entries and introduce a series of uncertainties e.g. varying allowed price and awarded subsidy. Also if the label is not approved for marketing, all packaged...

  15. The effect of coenzyme Q10 in statin myopathy.

    Science.gov (United States)

    Zlatohlavek, Lukas; Vrablik, Michal; Grauova, Barbora; Motykova, Eva; Ceska, Richard

    2012-01-01

    Statins significantly reduce CV morbidity and mortality. Unfortunately, one of the side effects of statins is myopathy, for which statins cannot be administered in sufficient doses or administered at all. The aim of this study was to demonstrate the effect of coenzyme Q10 in patients with statin myopathy. Twenty eight patients aged 60.6±10.7 years were monitored (18 women and 10 men) and treated with different types and doses of statin. Muscle weakness and pain was monitored using a scale of one to ten, on which patients expressed the degree of their inconvenience. Examination of muscle problems was performed prior to administration of CQ10 and after 3 and 6 months of dosing. Statistical analysis was performed using Friedman test, Annova and Students t-test. Pain decreased on average by 53.8% (pmuscle weakness by 44.4% (pmuscle pain and sensitivity statistically significantly decreased.

  16. Coenzyme Q10 prevented full blown splenomegaly and decreased melarsoprol-induced reactive encephalopathy in mice infected with Trypanosoma brucei rhodesiense

    Directory of Open Access Journals (Sweden)

    James Nyabuga Nyariki

    2015-03-01

    Full Text Available Objective: To establish the modulatory effects of coenzyme Q10 on experimental trypanosome infections in mice and evaluate the risk of occurrence and severity of melarsoprol-induced post treatment reactive encephalopathy (PTRE. Methods: Female Swiss white mice were orally administered with 200 mg/kg of coenzyme Q10 after which they were intraperitoneally inoculated with Trypanasoma brucei rhodesiense (T. b. rhodesiense. The resultant infection was allowed to develop and simulate all phases of human African trypanosomiasis and PTRE. Parasitaemia development, packed cell volume, haematological and pathological changes were determined. Results: A histological study in the brain tissue of T. b. rhodesiense infected mice demonstrated neuroinflammatory pathology which was highly amplified in the PTRE-induced groups. A prominent reduction in the severity of the neuroinflammatory response was detected when coenzyme-Q10 was administered. Furthermore, the mean tissue weight of spleen to body ratio in coenzyme Q10 supplemented group was significantly (P<0.05 different compared to un-supplemented groups, and clearly indicated that coenzyme Q10 prevented full blown splenomegaly pathogenesis by T. b. rhodesiense. A significant (P<0.05 increase in hemoglobin levels and red blood cells was observed in coenzyme Q10 mice compared to those infected and un-supplemented with coenzyme Q10. Conclusions: The capacity of coenzyme Q10 to alter the pathogenesis of T. b. rhodesiense infection in mice and following treatment with melarsoprol, may find application by rendering humans and animals less susceptible to deleterious effects of trypanosome infection such as splenomegaly and melarsoprol-induced PTRE and neurotoxicity.

  17. Analysis of the importance of drug packaging quality for end users and pharmaceutical industry as a part of the quality management system

    Directory of Open Access Journals (Sweden)

    Lončar Irma M.

    2013-01-01

    Full Text Available In this study, we collected and analyzed information on the importance of drug packaging quality to end users and pharmaceutical industry, as an indicator of the process of traceability and originality of drugs. Two surveys were conducted: one among the end users of drugs (252 patients and the other among professionals working in seven pharmaceutical companies in Serbia. For most end users (82.5% quality on the packaging of drugs was important, but only 41.8% of them thought that the appearance of the packaging could be an indicator of genuinity of drugs. The existence of the control marks (KM on drug packaging was not of great importance, since most of them (86.9% know, its function, but majority (60.2% would nevertheless decide to buy the drug without KM. Regarding the experts from the pharmaceutical industry, more then two-thirds of them (68.4% believed that the existence of KM did not contribute to efficient operations. Although a great number of pharmaceutical industry professionals (84.2% answered that the introduction of GS1 DataMatrix system would allow for complete traceability of the drug from the manufacturer to the end user, only 22.2% of them introduced this system to their products. This study also showed that domestic producers did not have a great interest for additional protection (special inks, holograms, special graphics, smart multicolor design, watermark, chemically labeled paper and cardboard etc.. on their products, given that only 15.8 % of them had some kind of additional protection against counterfeiting. Monitoring drug traceability from a manufacturer to end user is achieved by many complex activities regulated by law. A high percentage of responders said they were satisfied with the functionality of traceability systems used in their companies. As a way to increase the quality of drug packaging and business performance most responders saw in the continuous improvement of the system of traceability within the company

  18. Pharmaceutical technology management--profitable business avenue.

    Science.gov (United States)

    Puthli, Shivanand P

    2010-01-01

    Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business.

  19. ADCK3, an ancestral kinase, is mutated in a form of recessive ataxia associated with coenzyme Q10 deficiency.

    Science.gov (United States)

    Lagier-Tourenne, Clotilde; Tazir, Meriem; López, Luis Carlos; Quinzii, Catarina M; Assoum, Mirna; Drouot, Nathalie; Busso, Cleverson; Makri, Samira; Ali-Pacha, Lamia; Benhassine, Traki; Anheim, Mathieu; Lynch, David R; Thibault, Christelle; Plewniak, Frédéric; Bianchetti, Laurent; Tranchant, Christine; Poch, Olivier; DiMauro, Salvatore; Mandel, Jean-Louis; Barros, Mario H; Hirano, Michio; Koenig, Michel

    2008-03-01

    Muscle coenzyme Q(10) (CoQ(10) or ubiquinone) deficiency has been identified in more than 20 patients with presumed autosomal-recessive ataxia. However, mutations in genes required for CoQ(10) biosynthetic pathway have been identified only in patients with infantile-onset multisystemic diseases or isolated nephropathy. Our SNP-based genome-wide scan in a large consanguineous family revealed a locus for autosomal-recessive ataxia at chromosome 1q41. The causative mutation is a homozygous splice-site mutation in the aarF-domain-containing kinase 3 gene (ADCK3). Five additional mutations in ADCK3 were found in three patients with sporadic ataxia, including one known to have CoQ(10) deficiency in muscle. All of the patients have childhood-onset cerebellar ataxia with slow progression, and three of six have mildly elevated lactate levels. ADCK3 is a mitochondrial protein homologous to the yeast COQ8 and the bacterial UbiB proteins, which are required for CoQ biosynthesis. Three out of four patients tested showed a low endogenous pool of CoQ(10) in their fibroblasts or lymphoblasts, and two out of three patients showed impaired ubiquinone synthesis, strongly suggesting that ADCK3 is also involved in CoQ(10) biosynthesis. The deleterious nature of the three identified missense changes was confirmed by the introduction of them at the corresponding positions of the yeast COQ8 gene. Finally, a phylogenetic analysis shows that ADCK3 belongs to the family of atypical kinases, which includes phosphoinositide and choline kinases, suggesting that ADCK3 plays an indirect regulatory role in ubiquinone biosynthesis possibly as part of a feedback loop that regulates ATP production.

  20. Normas para la publicación de investigaciones clínicas patrocinadas por la industria farmacéutica Publication standards for clinical research sponsored by the pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    2003-07-01

    Full Text Available The role played by the private sector, in particular the pharmaceutical industry, in funding research has been growing at an accelerated pace in recent decades. So much so, in fact, that the private sector has become the primary funding source of clinical trials in some countries. As a result, pharmaceutical companies exercise ever-growing control over not only the design of clinical trials but also the publication of their results. The conflicts of interest involved in this kind of situation can lead to ethical breaches (for example, suppression or distortion of results or the intimidation of investigators, and it is crucial to take concrete steps to guard against such breaches. This is exactly what a Working Group made up of members of the pharmaceutical industry itself has done, preparing a series of guidelines for that industry in order to promote good publication practices. These guidelines, which were just recently published in English, represent an important step in efforts to achieve greater transparency and accountability in the presentation of results of research funded by manufacturers of pharmaceutical products. Although the guidelines, now translated into Spanish in this piece, are subject to future revisions, they are a valuable starting point for further discussion of a problem that deserves the urgent attention of the scientific community.

  1. Characterization of the evolution of the pharmaceutical regulatory environment.

    Science.gov (United States)

    Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

    2013-01-01

    This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main

  2. Perception and application of the concept “quality by design” (QbD) by the pharmaceutical industry in Portugal

    OpenAIRE

    Garcia, Ana Cristina; Fernandes, Paula O.; Santos, Andreia

    2014-01-01

    The Quality by Design (QbD) paradigm states that in order to ensure predefined product quality, improve manufacturing quality performance, and serve customers’ needs one must fully understand the processes behind it. With the purpose of assessing the perception of the pharmaceutical industry in Portugal about the usefulness of a strategy for development, production optimization and control/quality management according to the QbD concept and its level of implementation, we conducted a survey a...

  3. Genetic Rescue of Mitochondrial and Skeletal Muscle Impairment in an Induced Pluripotent Stem Cells Model of Coenzyme Q10 Deficiency.

    Science.gov (United States)

    Romero-Moya, Damià; Santos-Ocaña, Carlos; Castaño, Julio; Garrabou, Gloria; Rodríguez-Gómez, José A; Ruiz-Bonilla, Vanesa; Bueno, Clara; González-Rodríguez, Patricia; Giorgetti, Alessandra; Perdiguero, Eusebio; Prieto, Cristina; Moren-Nuñez, Constanza; Fernández-Ayala, Daniel J; Victoria Cascajo, Maria; Velasco, Iván; Canals, Josep Maria; Montero, Raquel; Yubero, Delia; Jou, Cristina; López-Barneo, José; Cardellach, Francesc; Muñoz-Cánoves, Pura; Artuch, Rafael; Navas, Plácido; Menendez, Pablo

    2017-07-01

    Coenzyme Q 10 (CoQ 10 ) plays a crucial role in mitochondria as an electron carrier within the mitochondrial respiratory chain (MRC) and is an essential antioxidant. Mutations in genes responsible for CoQ 10 biosynthesis (COQ genes) cause primary CoQ 10 deficiency, a rare and heterogeneous mitochondrial disorder with no clear genotype-phenotype association, mainly affecting tissues with high-energy demand including brain and skeletal muscle (SkM). Here, we report a four-year-old girl diagnosed with minor mental retardation and lethal rhabdomyolysis harboring a heterozygous mutation (c.483G > C (E161D)) in COQ4. The patient's fibroblasts showed a decrease in [CoQ 10 ], CoQ 10 biosynthesis, MRC activity affecting complexes I/II + III, and respiration defects. Bona fide induced pluripotent stem cell (iPSCs) lines carrying the COQ4 mutation (CQ4-iPSCs) were generated, characterized and genetically edited using the CRISPR-Cas9 system (CQ4 ed -iPSCs). Extensive differentiation and metabolic assays of control-iPSCs, CQ4-iPSCs and CQ4 ed -iPSCs demonstrated a genotype association, reproducing the disease phenotype. The COQ4 mutation in iPSC was associated with CoQ 10 deficiency, metabolic dysfunction, and respiration defects. iPSC differentiation into SkM was compromised, and the resulting SkM also displayed respiration defects. Remarkably, iPSC differentiation in dopaminergic or motor neurons was unaffected. This study offers an unprecedented iPSC model recapitulating CoQ 10 deficiency-associated functional and metabolic phenotypes caused by COQ4 mutation. Stem Cells 2017;35:1687-1703. © 2017 AlphaMed Press.

  4. The emerging role of MD Pharmacology postgraduate in pharmaceutical industry

    OpenAIRE

    Pratishtha Banga Chaudhari

    2016-01-01

    Patient-benefit is a shared goal of the pharmaceutical company and the treating doctor. At the same time, the pharmaceutical company- in order to recur its R and D costs has to balance patient centricity with making profits. Consequently, the commercial benefits from prescription of a product and education about optimal use of product both become the responsibilities of same organization. This often leads to allegations of bias by the regulators. We are in an era where regulatory bodies close...

  5. Chemometrics-based process analytical technology (PAT) tools: applications and adaptation in pharmaceutical and biopharmaceutical industries.

    Science.gov (United States)

    Challa, Shruthi; Potumarthi, Ravichandra

    2013-01-01

    Process analytical technology (PAT) is used to monitor and control critical process parameters in raw materials and in-process products to maintain the critical quality attributes and build quality into the product. Process analytical technology can be successfully implemented in pharmaceutical and biopharmaceutical industries not only to impart quality into the products but also to prevent out-of-specifications and improve the productivity. PAT implementation eliminates the drawbacks of traditional methods which involves excessive sampling and facilitates rapid testing through direct sampling without any destruction of sample. However, to successfully adapt PAT tools into pharmaceutical and biopharmaceutical environment, thorough understanding of the process is needed along with mathematical and statistical tools to analyze large multidimensional spectral data generated by PAT tools. Chemometrics is a chemical discipline which incorporates both statistical and mathematical methods to obtain and analyze relevant information from PAT spectral tools. Applications of commonly used PAT tools in combination with appropriate chemometric method along with their advantages and working principle are discussed. Finally, systematic application of PAT tools in biopharmaceutical environment to control critical process parameters for achieving product quality is diagrammatically represented.

  6. [The pharmaceutical industry and the sustainability of healthcare systems in developed countries and in Latin America].

    Science.gov (United States)

    Iñesta, Antonio; Oteo, Luis Angel

    2011-06-01

    The global economic crisis and its impact on public finances in most developed countries are giving rise to cost-containment policies in healthcare systems. Prevailing legislation on medication requires the safety, quality, and efficacy of these products. A few countries include efficiency criteria, primarily for new medication that they wish to include in public financing. The appropriate use of generic and "biosimilar medication" is very important for maintaining the financial equilibrium of the Health Services. The problem in Latin America is that not all multisource products are bioequivalent and not all countries have the resources to conduct bioequivalence studies in vivo. The European Medicines Agency in 2005 adopted guidelines on "biosimilar medicines" and thirteen of them were subsequently approved for general release. Benchmarking of this model by other countries would be important. The influence of the pharmaceutical industry on political and administrative areas is enormous and control is necessary. The pharmaceutical companies claim that they act with corporate social responsibility, therefore, they must ensure this responsibility toward society.

  7. An Assay of Bax and Bcl2 Expression in Mice Hippocampus Following Ischemia-Reperfusion Treatment with CoQ10

    Directory of Open Access Journals (Sweden)

    Jalal Hassanshahi

    2013-10-01

    Full Text Available Introduction: Preliminary studies confirmed reduction of cell death following treatment with antioxidants. According to this finding we investigated the relationship between consumption of CoQ10 and expression of bax and bcl2 in hippocampus ischemia that this expression related to cell programmed death.Material and Methods: We studied the protective role of CoQ10 against ischemia-reperfusion. Experimental design includes four groups: intact (N=7, ischemic control (N=7, sham control (N=7 and treatment groups with CoQ10 (N=7. The mice (treatment group treated with CoQ10 as Pre-Treatment for a week. Then, ischemia induced by common carotid artery ligation and following the reduction in inflammation (a week the treatment group post-treated with CoQ10 for a week. Nissl staining applied to counting necrotic cells of hippocampus and the western blotting performed to measurement the bax and bcl2 expression. Tunnel kit was used to quantify apoptotic cell death while to short term memory scale, we apply Y-maze.Results: Cell death was significantly lower when mice treated with CoQ10. Bax expression was significantly high in ischemic group but in treatment group was less and reversely the bcl2 expression in ischemic group was lower than treatment and vehicle groups. The memory test results were consistent with cell death results. Conclusion: Ischemia for 15 minutes induced cell death in hippocampus with more potent effect on CA1. CoQ10 intake significantly reduced cell death and decreased memory loss. with prevent of expression of bax and increase in expression of bcl2.

  8. [Early achievements of the Danish pharmaceutical industry--8. Lundbeck].

    Science.gov (United States)

    Grevsen, Jørgen V; Kirkegaard, Hanne; Kruse, Edith; Kruse, Poul R

    2016-01-01

    The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 8 deals with products from Lundbeck. Lundbeck which today is known as a considerable international pharmaceutical company could in 2015 celebrate its 100 years' jubilee. Among the early Danish medicinal companies H. Lundbeck & Co. is in many ways an exception as the company was not originally established as a pharmaceutical company. Not until several years after the foundation the company began to import foreign ready-made medicinal products and later-on to manufacture these medicinal products in own factory and even later to do research and development of own innovative products. When Lundbeck was established in 1915 several Danish medicinal companies, not only the well-known such as Alfred Benzon and Løvens kemiske Fabrik (LEO Pharma), but also Skelskør Frugtplantage, Ferrin and Ferraton, had emerged due to the respective enterprising pharmacy owners who had expanded their traditional pharmacy business and even with commercial success. Other medicinal companies, such as C.R. Evers & Co., Leerbeck & Holms kemiske Fabriker, Chr. F. Petri, Erslevs kemiske Laboratorium, Edward Jacobsen, Th. Fallesen-Schmidt, and yet other companies which were named after the founder had all been established by pharmacists with the primary intention to manufacture and sell medicinal products. Also for the limited companies Medicinalco, Ferrosan, Pharmacia, and GEA the primary task was to manufacture and sell medicinal products, and also in these companies pharmacists were involved in the foundation. Not until 1924, fully 9 years after the foundation, Lundbeck started to be interested in medicinal products and initiated import and sale of foreign medicinal products manufactured by a.o. German and French companies which had not established their own sales companies in Denmark. Almost all contemporary Danish manufacturers of

  9. Effect of DHA and CoenzymeQ10 Against Aβ- and Zinc-Induced Mitochondrial Dysfunction in Human Neuronal Cells

    Directory of Open Access Journals (Sweden)

    Nadia Sadli

    2013-07-01

    Full Text Available Background: Beta-amyloid (Aβ protein is a key factor in the pathogenesis of Alzheimer's disease (AD and it has been reported that mitochondria is involved in the biochemical pathway by which Aβ can lead to neuronal dysfunction. Coenzyme Q10 (CoQ10 is an essential cofactor involved in the mitochondrial electron transport chain and has been suggested as a potential therapeutic agent in AD. Zinc toxicity also affects cellular energy production by decreasing oxygen consumption rate (OCR and ATP turnover in human neuronal cells, which can be restored by the neuroprotective effect of docosahexaenoic acid (DHA. Method: In the present study, using Seahorse XF-24 Metabolic Flux Analysis we investigated the effect of DHA and CoQ10 alone and in combination against Aβ- and zinc-mediated changes in the mitochondrial function of M17 neuroblastoma cell line. Results: Here, we observed that DHA is specifically neuroprotective against zinc-triggered mitochondrial dysfunction, but does not directly affect Aβ neurotoxicity. CoQ10 has shown to be protective against both Aβ- and zinc-induced alterations in mitochondrial function. Conclusion: Our results indicate that DHA and CoQ10 may be useful for the prevention, treatment and management of neurodegenerative diseases such as AD.

  10. Coenzyme Q10 and pro-inflammatory markers in children with Down syndrome: clinical and biochemical aspects.

    Science.gov (United States)

    Zaki, Moushira E; El-Bassyouni, Hala T; Tosson, Angie M S; Youness, Eman; Hussein, Jihan

    Evidence of oxidative stress was reported in individuals with Down syndrome. There is a growing interest in the contribution of the immune system in Down syndrome. The aim of this study is to evaluate the coenzyme Q10 and selected pro-inflammatory markers such as interleukin 6 and tumor necrosis factor α in children with Down syndrome. Eighty-six children (5-8 years of age) were enrolled in this case-control study from two public institutions. At the time of sampling, the patients and controls suffered from no acute or chronic illnesses and received no therapies or supplements. The levels of interleukin 6, tumor necrosis factor α, coenzyme Q10, fasting blood glucose, and intelligence quotient were measured. Forty-three young Down syndrome children and forty-three controls were included over a period of eight months (January-August 2014). Compared with the control group, the Down syndrome patients showed significant increase in interleukin 6 and tumor necrosis factor α (p=0.002), while coenzyme Q10 was significantly decreased (p=0.002). Also, body mass index and fasting blood glucose were significantly increased in patients. There was a significantly positive correlation between coenzyme Q10 and intelligence quotient levels, as well as between interleukin 6 and tumor necrosis factor α. Interleukin 6 and tumor necrosis factor α levels in young children with Down syndrome may be used as biomarkers reflecting the neurodegenerative process in them. Coenzyme Q10 might have a role as a good supplement in young children with Down syndrome to ameliorate the neurological symptoms. Copyright © 2016 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

  11. Coenzyme Q10 and pro-inflammatory markers in children with Down syndrome: clinical and biochemical aspects

    Directory of Open Access Journals (Sweden)

    Moushira E. Zaki

    Full Text Available Abstract: Objective: Evidence of oxidative stress was reported in individuals with Down syndrome. There is a growing interest in the contribution of the immune system in Down syndrome. The aim of this study is to evaluate the coenzyme Q10 and selected pro-inflammatory markers such as interleukin 6 and tumor necrosis factor α in children with Down syndrome. Methods: Eighty-six children (5-8 years of age were enrolled in this case-control study from two public institutions. At the time of sampling, the patients and controls suffered from no acute or chronic illnesses and received no therapies or supplements. The levels of interleukin 6, tumor necrosis factor α, coenzyme Q10, fasting blood glucose, and intelligence quotient were measured. Results: Forty-three young Down syndrome children and forty-three controls were included over a period of eight months (January-August 2014. Compared with the control group, the Down syndrome patients showed significant increase in interleukin 6 and tumor necrosis factor α (p = 0.002, while coenzyme Q10 was significantly decreased (p = 0.002. Also, body mass index and fasting blood glucose were significantly increased in patients. There was a significantly positive correlation between coenzyme Q10 and intelligence quotient levels, as well as between interleukin 6 and tumor necrosis factor α. Conclusion: Interleukin 6 and tumor necrosis factor α levels in young children with Down syndrome may be used as biomarkers reflecting the neurodegenerative process in them. Coenzyme Q10 might have a role as a good supplement in young children with Down syndrome to ameliorate the neurological symptoms.

  12. Effect of the additives on clouding behavior and thermodynamics of coenzyme Q10-Kolliphor HS15 micelle aqueous solutions

    Science.gov (United States)

    Hu, Li; Zhang, Jing; Zhu, Chao; Pan, Hong-chun; Liu, Hong

    2017-11-01

    Herein we investigate the effect of different additives (electrolytes, amino acids, PEG, and sugars) on the cloud points (CP) of coenzyme Q10 (CoQ10) - Kolliphor HS15 (HS15) micelle aqueous solutions. The CP values were decreased with the increase of electrolytes and sugars, following: CPAl3+ reduced the CP. A depression of CP for CoQ10-HS15 micelle solution with PEG was molecular weight of PEG dependent. The significant thermodynamic parameters were also evaluated and discussed.

  13. New product testing and the utilization of user expertise: Evidence from the Pharmaceutical industry

    DEFF Research Database (Denmark)

    Smed, Marie; Salomo, Søren; Schultz, Carsten

    2012-01-01

    A significant and often neglected obstacle in new product development is the testing and approval process in the late stages of development. The testing process has primarily been observed as an in-house decision process, however, in many industries products undergo extensive testing before marke....... Further, with a dispersed user network a positive effect is observed on the mean to communicate directly as issues occur. The effect of virtual communication is therefore stronger than traditional face-to-face interaction patterns.......A significant and often neglected obstacle in new product development is the testing and approval process in the late stages of development. The testing process has primarily been observed as an in-house decision process, however, in many industries products undergo extensive testing before market...... the knowledge generated and shared by medical sites and Pharmaceutical producers in late stage product development. The results show, that information regarding usage patterns and product related services are more difficult to transfer between user and developer, than issues directly related to the product...

  14. Invariant-mass distributions for the pp{yields}pp{eta} reaction at Q=10 MeV

    Energy Technology Data Exchange (ETDEWEB)

    Moskal, P.; Czerwinski, E.; Klaja, J.; Klaja, P.; Krzemien, W. [Jagellonian University, Institute of Physics, Cracow (Poland); Research Center Juelich, Nuclear Physics Institute, Juelich (Germany); Czyzykiewicz, R. [Jagellonian University, Institute of Physics, Cracow (Poland); University of Silesia, Institute of Physics, Katowice (Poland); Gil, D.; Jarczyk, L.; Kamys, B.; Silarski, M.; Smyrski, J.; Zdebik, J.; Zielinski, M.J. [Jagellonian University, Institute of Physics, Cracow (Poland); Grzonka, D.; Oelert, W.; Ritman, J.; Sefzick, T.; Wuestner, P. [Research Center Juelich, Nuclear Physics Institute, Juelich (Germany); Khoukaz, A.; Taeschner, A.; Zipper, W. [Westfaelische Wilhelms-Universitaet, IKP, Muenster (Germany); Siemaszko, M. [University of Silesia, Institute of Physics, Katowice (Poland); Wolke, M. [SE-751 05 Uppsala University, Department of Physics and Astronomy, Uppsala (Sweden)

    2010-02-15

    Proton-proton and proton-{eta} invariant-mass distributions and the total cross-section for the pp{yields}pp{eta} reaction have been determined near the threshold at an excess energy of Q=10 MeV. The experiment has been conducted using the COSY-11 detector setup and the cooler synchrotron COSY. The determined invariant-mass spectra reveal significant enhancements in the region of low proton-proton relative momenta, similarly as observed previously at higher excess energies of Q=15.5 MeV and Q=40 MeV. (orig.)

  15. Replication the association of 2q32.2-q32.3 and 14q32.11 with hepatocellular carcinoma.

    Science.gov (United States)

    Chen, Wei; Wang, Mi