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Sample records for industry q10 pharmaceutical

  1. Coenzyme Q10 analytical determination in biological matrices and pharmaceuticals.

    PubMed

    Lucangioli, Silvia; Martinefski, Manuela; Tripodi, Valeria

    2016-06-01

    In recent years, the analytical determination of coenzyme Q10 (CoQ10) has gained importance in clinical diagnosis and in pharmaceutical quality control. CoQ10 is an important cofactor in the mitochondrial respiratory chain and a potent endogenous antioxidant. CoQ10 deficiency is often associated with numerous diseases and patients with these conditions may benefit from administration of supplements of CoQ10. In this regard, it has been observed that the best benefits are obtained when CoQ10 deficiency is diagnosed and treated early. Therefore, it is of great value to develop analytical methods for the detection and quantification of CoQ10 in this type of disease. The methods above mentioned should be simple enough to be used in routine clinical laboratories as well as in quality control of pharmaceutical formulations containing CoQ10. Here, we discuss the advantages and disadvantages of different methods of CoQ10 analysis.

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

    PubMed

    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."

  3. 76 FR 57746 - Conference on the International Conference on Harmonisation Q10 Pharmaceutical Quality System: A...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-16

    ... Q10 Pharmaceutical Quality System: A Practical Approach to Effective Life- Cycle Implementation of... Registration of Pharmaceuticals for Human Use (ICH) entitled ``Pharmaceutical Quality System (ICH Q10) Conference: A Practical Approach to Effective Life- Cycle Implementation of Systems and Processes for...

  4. Densitometric HPTLC method for qualitative, quantitative analysis and stability study of Coenzyme Q10 in pharmaceutical formulations utilizing normal and reversed-phase silica gel plates.

    PubMed

    Abdel-Kader, Maged Saad; Alam, Prawez; Alqasoumi, Saleh Ibrahim

    2016-03-01

    Two simple, precise and stability-indicating densitometric HPTLC method were developed and validated for qualitative and quantitative analysis of Coenzyme Q10 in pharmaceutical formulations using normal-phase (Method I) and reversed phase (Method II) silica gel TLC plates. Both methods were developed and validated with 10×20 cm glass-backed plates coated with 0.2 mm layers of either silica gel 60 F254 (E-Merck, Germany) using hexane-ethyl acetate (8.5:1.5 v/v) as developing system (Method I) or RP-18 silica gel 60 F254 (E-Merck, Germany) using methanol-acetone (4:6 v/v) as mobile phase (Method II). Both analyses were scanned with a densitometer at 282 nm. Linearity was found in the ranges 50-800 ng/spot (r(2)=0.9989) and 50-800 ng/spot (r(2)=0.9987) for Method I and Method II respectively. Stability of Coenzyme Q10 was explored by the two methods using acid, base, hydrogen peroxide, temperature and different solvents. Due to the efficiency of the method in separating Coenzyme Q10 from other ingredients including its degradation products, it can be applied for quality control, standardization of different pharmaceutical formulations and stability study.

  5. The production of coenzyme Q10 in microorganisms.

    PubMed

    Cluis, Corinne P; Pinel, Dominic; Martin, Vincent J

    2012-01-01

    Coenzyme Q10 has emerged as a valuable molecule for pharmaceutical and cosmetic applications. Therefore, research into producing and optimizing coenzyme Q10 via microbial fermentation is ongoing. There are two major paths being explored for maximizing production of this molecule to commercially advantageous levels. The first entails using microbes that naturally produce coenzyme Q10 as fermentation biocatalysts and optimizing the fermentation parameters in order to reach industrial levels of production. However, the natural coenzyme Q10-producing microbes tend to be intractable for industrial fermentation settings. The second path to coenzyme Q10 production being explored is to engineer Escherichia coli with the ability to biosynthesize this molecule in order to take advantage of its more favourable fermentation characteristics and the well-understood array of genetic tools available for this bacteria. Although many studies have attempted to over-produce coenzyme Q10 in E. coli through genetic engineering, production titres still remain below those of the natural coenzyme Q10-producing microorganisms. Current research is providing the knowledge needed to alleviate the bottlenecks involved in producing coenzyme Q10 from an E. coli strain platform and the fermentation parameters that could dramatically increase production titres from natural microbial producers. Synthesizing the lessons learned from both approaches may be the key towards a more cost-effective coenzyme Q10 industry.

  6. [Pharmaceuticals: a strategic national industry].

    PubMed

    Hollender, Louis

    2004-01-01

    Asked by Mme Nicole Fontaine, Delegate Minister of Industry, to help the government with its ongoing reflections on pharmaceutical industrial strategy, and the necessary autonomy of our country in the face of major commercial threats, a working group of the French National Academy of Medicine consulted representatives of five French and two foreign major drug companies. Their statements can be classified in four categories:--the first concerns new medications, which must be approved successively by three commissions, whose opinions are often delayed and influenced by economic considerations;--second, public and private research are both insufficient and are sometimes hindered by procedural restrictions,--third, the pharmaceutical industry is unable to deal with frequent and unforseeable political upheavals,--France does not adequately recognize the strategic importance of the pharmaceutical industry in the national economy. The Academy makes several recommendations: the French pharmaceutical industry should be considered as a national priority, the strategic importance of national pharmaceutical companies should be recognized, a multi-annual contract should be signed with manufacturers, clinical trials should be facilitated in France, relationships between the national pharmaceutical industry and public research structures should be reinforced, and an inter-ministerial Council on Pharmaceuticals should be created. This study was supplemented by a survey of veterinary medications, the results and conclusions of which are very similar to those outlined above for human medicines.

  7. Chemistry in the Pharmaceutical Industry

    NASA Astrophysics Data System (ADS)

    Poindexter, Graham S.; Pendri, Yadagiri; Snyder, Lawrence B.; Yevich, Joseph P.; Deshpande, Milind

    This chapter will discuss the role of chemistry within the pharmaceutical industry. Although the focus will be upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first world nations such as Japan and those in Europe. The major objective of the pharmaceutical industry is the discovery, development, and marketing of efficacious and safe drugs for the treatment of human disease. Of course drug companies do not exist as altruistic, charitable organizations but like other share-holder owned corporations within our capitalistic society must achieve profits in order to remain viable and competitive. Thus, there exists a conundrum between the dual goals of enhancing the quality and duration of human life and that of increasing stock-holder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships this places upon the elderly and others of limited income.

  8. Coenzyme Q10 Therapy

    PubMed Central

    Garrido-Maraver, Juan; Cordero, Mario D.; Oropesa-Ávila, Manuel; Fernández Vega, Alejandro; de la Mata, Mario; Delgado Pavón, Ana; de Miguel, Manuel; Pérez Calero, Carmen; Villanueva Paz, Marina; Cotán, David; Sánchez-Alcázar, José A.

    2014-01-01

    For a number of years, coenzyme Q10 (CoQ10) was known for its key role in mitochondrial bioenergetics; later studies demonstrated its presence in other subcellular fractions and in blood plasma, and extensively investigated its antioxidant role. These 2 functions constitute the basis for supporting the clinical use of CoQ10. Also, at the inner mitochondrial membrane level, CoQ10 is recognized as an obligatory cofactor for the function of uncoupling proteins and a modulator of the mitochondrial transition pore. Furthermore, recent data indicate that CoQ10 affects the expression of genes involved in human cell signaling, metabolism and transport, and some of the effects of CoQ10 supplementation may be due to this property. CoQ10 deficiencies are due to autosomal recessive mutations, mitochondrial diseases, aging-related oxidative stress and carcinogenesis processes, and also statin treatment. Many neurodegenerative disorders, diabetes, cancer, and muscular and cardiovascular diseases have been associated with low CoQ10 levels as well as different ataxias and encephalomyopathies. CoQ10 treatment does not cause serious adverse effects in humans and new formulations have been developed that increase CoQ10 absorption and tissue distribution. Oral administration of CoQ10 is a frequent antioxidant strategy in many diseases that may provide a significant symptomatic benefit. PMID:25126052

  9. Immunotoxicology in the pharmaceutical industry.

    PubMed Central

    Norbury, K C

    1982-01-01

    Development of an immunotoxicology program within the pharmaceutical industry is described. With few guidelines in the area and a multitude of factors to consider, a basic screen for evaluating immune competence in species routinely used in toxicologic studies has been proposed. The future of immunotoxicology depends upon the ability of the selected immune function tests to be predictive of human risk. PMID:7037389

  10. The pharmaceutical industry in Cuba.

    PubMed

    Tancer, R S

    1995-01-01

    Cuba has developed a relatively sophisticated pharmaceutical sector, originally to provide medicinal products for her own population and, more recently, to earn hard currency through exports. Cuba has achieved both of these goals despite the US trade embargo, which isolates Cuba from commercial relations with US firms. Cuba is opening its economy to firms from other countries through the use of joint ventures and other forms of cooperation. US firms are unable to avail themselves of these opportunities, and the opportunities are thus being lost. In the case of pharmaceuticals, the Cubans recognize that they need assistance, particularly in the areas of marketing and packaging. Allowing the participation of US firms in the Cuban pharmaceutical industry could enhance the possibility of improving worldwide health care.

  11. Bioremediation of industrial pharmaceutical drugs.

    PubMed

    Mansour, Hedi Ben; Mosrati, Ridha; Barillier, Daniel; Ghedira, Kamel; Chekir-Ghedira, Leila

    2012-07-01

    Recently, attention has been drawn toward the occurrence of pharmaceuticals in the environment. In recent years, many reports have been made on the occurrence of the large, differentiated group of pharmaceuticals in wastewater (PW), surface water, ground water, and in soil. The pharmaceutical sector is currently expanding in Tunisia, with more than 34 industries. The aim of this work was to evaluate the ability of Pseudomonas putida mt-2 to treat PW. P. putida was very efficient in reducing chemical oxygen demand (COD), total dissolved solids (TDS), and turbidity of solution (85.5, 89.1, and 81.5%, respectively). Genotoxicity of effluent, before and after biodegradation, was evaluated in vivo in mouse bone marrow by assessing the percentage of cells bearing different chromosome aberrations. Results indicated that PW showed a significant ability to induce DNA damage. In addition, PW induced a remarkable lipid peroxidation (LPO) effect, however, activities of both acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE) were unchanged when treated with PW, compared to nontreated PW. This toxicity was imputed to the presence of pharmaceutical compounds in wastewater. However, chromosome aberration, as well as LPO of PW, were significantly reduced after bioremediation. Thus, the use of this strain for testing on the industrial scale seems possible and advantageous.

  12. Coenzyme Q10 (PDQ)

    MedlinePlus

    ... healthy. The body also uses CoQ10 as an antioxidant . An antioxidant is a substance that protects cells from chemicals ... of cancer. By protecting cells against free radicals, antioxidants help protect the body against cancer. CoQ10 is ...

  13. Ethics and the pharmaceutical industry.

    PubMed

    Green, Stephen

    2008-06-01

    Relationships between the pharmaceutical industry and the medical profession enhance the potential for physicians to become involved in conflicts of interest. Whether or not these rise to a level that violates standards of medical ethics depends on the degree to which they detract from the quality of health care and its cost, the objectivity of research, and the profession's integrity. This paper explores those issues from two perspectives--the micro-level of the medical profession and the macro-level of society. Practices and policies that affect varied aspects of the interaction between the pharmaceutical industry and the medical profession--such as education, research and marketing--are discussed. The reader is asked to reflect on the ethics of issues raised; the author offers suggestions for mitigating conflicts of interest and, in turn, the potential for unethical medical care.

  14. [Production of coenzyme Q10 by metabolically engineered Escherichia coli].

    PubMed

    Dai, Guanping; Miao, Liangtian; Sun, Tao; Li, Qingyan; Xiao, Dongguang; Zhang, Xueli

    2015-02-01

    Coenzyme Q10 (CoQ10) is a lipophilic antioxidant that improves human immunity, delays senility and enhances the vitality of the human body and has wide applications in pharmaceutical and cosmetic industries. Microbial fermentation is a sustainable way to produce CoQ10, and attracts increased interest. In this work, the native CoQ8 synthetic pathway of Escherichia coli was replaced by the CoQ10 synthetic pathway through integrating decaprenyl diphosphate synthase gene (dps) from Rhodobacter sphaeroides into chromosome of E. coli ATCC 8739, followed by deletion of the native octaprenyl diphosphate synthase gene (ispB). The resulting strain GD-14 produced 0.68 mg/L CoQ10 with a yield of 0.54 mg/g DCW. Modulation of dxs and idi genes of the MEP pathway and ubiCA genes in combination led to 2.46-fold increase of CoQ10 production (from 0.54 to 1.87 mg/g DCW). Recruiting glucose facilitator protein of Zymomonas mobilis to replace the native phosphoenolpyruvate: carbohydrate phosphotransferase systems (PTS) further led to a 16% increase of CoQ10 yield. Finally, fed-batch fermentation of the best strain GD-51 was performed, which produced 433 mg/L CoQ10 with a yield of 11.7 mg/g DCW. To the best of our knowledge, this was the highest CoQ10 titer and yield obtained for engineered E. coli.

  15. Pharmacy residents' attitudes toward pharmaceutical industry promotion.

    PubMed

    Ashker, Sumer; Burkiewicz, Jill S

    2007-08-15

    The attitudes of pharmacy residents toward pharmaceutical industry promotion and the perceived effects of such promotion on the knowledge and professional practice of the residents were studied. A questionnaire study of current postgraduate year 1 and postgraduate year 2 pharmacy residents was conducted. Questions were adapted from instruments used in studies of medical student or physician attitudes regarding the pharmaceutical industry. The questionnaire requested demographic information about the resident, information regarding the resident's exposure to specific types of pharmaceutical company-related activities, and the resident's perception of whether the residency program or department had policies or guidelines regarding interactions with the pharmaceutical industry. Questions investigated the attitudes toward pharmaceutical industry promotion and the perceived influence of pharmaceutical industry promotion on the professional knowledge and behavior of the residents. Responses were received from 496 pharmacy residents. Nearly all (89%) residents agreed that pharmaceutical company-sponsored educational events enhance knowledge. Almost half (43%) of the respondents reported that information from educational events influences therapeutic recommendations. One quarter (26%) of the pharmacy residents indicated prior training regarding pharmacist-industry interactions, and most (60%) residents indicated that their institution's residencies or departments have policies regarding interactions with the pharmaceutical industry. Most surveyed pharmacy residents believed that educational events sponsored by pharmaceutical companies enhance knowledge. Respondents whose institutions had policies or who had received training about such events were less likely than other respondents to perceive an influence of the events on their knowledge and behavior.

  16. Coenzyme Q10-containing composition (Immugen) protects against occupational and environmental stress in workers of the gas and oil industry.

    PubMed

    Korkina, Ludmila; Deeva, Irina; Ibragimova, Galina; Shakula, Alexander; Luci, Antonio; De Luca, Chiara

    2003-01-01

    The manual workers of the gas-and-oil extraction industry are exposed to hostile environmental and occupational conditions, resulting in elevated mortality and disability, due to chronic neurological and cardiovascular diseases. We evaluated the degree of oxidative stress, often associated with these pathological features, in the blood of manual and office employees of Russian Siberian extraction plants, and their psycho-physiological conditions. Results showed increased levels of spontaneous (p < 0.05) and PMA-activated (p < 0.01) luminol-dependent chemiluminescence (LDCL) in the white blood cells (WBC), and decreased peroxynitrite levels (p < 0.05) in the group of manual workers, and less markedly in the clerks and technicians working on spot, vs. a control group of city clerks. Superoxide release by WBC, and plasma/WBC membrane ubiquinol levels did not display major differences in the three groups. A relevant percentage of manual/office workers of extraction platforms presented impaired cardiovascular and neurological functions. The short term administration of a nutraceutical formulation based on coenzyme10, vitamin E, selenium, methionine and phospholipids led to significant improvement of cardiovascular parameters and psycho-emotional status, consistent with the normalization of LDCL and peroxynitrite production by WBC, with a good compliance to treatment confirmed by the increased blood levels of ubiquinol.

  17. Globalization and the pharmaceutical industry revisited.

    PubMed

    Busfield, Joan

    2003-01-01

    This survey of the pharmaceutical industry at the beginning of the 21st century updates some of the information provided in Claudio Tarabusi and Graham Vickery's survey, "Globalization in the Pharmaceutical Industry," published in the International Journal of Health Services in 1998, which was largely based on data up to 1993. However, the purpose of the present article differs from that of Tarabusi and Vickery, which covered a wide range of aspects of the industry relevant to globalization but did not explicitly address the question of the extent to which the industry could be described as globalized. After looking at the industry in some detail, the author directly confronts the question of the appropriateness of the use of the term "globalization" for characterizing the directions in which the pharmaceutical industry has been moving.

  18. Drug Information Residency Rotation with Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Cramer, Richard L.

    1986-01-01

    Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

  19. Developing Closer Ties with the Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Reid, Gregor; Hoddinott, Susan

    1991-01-01

    The need for research administrators to understand and appreciate the pharmaceutical industry's research and development environment is discussed, using examples from Canada. The research administrator's role in the technology transfer process and implications for faculty are examined. Ways to build closer school-industry ties are discussed. (MSE)

  20. Drug Information Residency Rotation with Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Cramer, Richard L.

    1986-01-01

    Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

  1. Developing Closer Ties with the Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Reid, Gregor; Hoddinott, Susan

    1991-01-01

    The need for research administrators to understand and appreciate the pharmaceutical industry's research and development environment is discussed, using examples from Canada. The research administrator's role in the technology transfer process and implications for faculty are examined. Ways to build closer school-industry ties are discussed. (MSE)

  2. Metrology in Pharmaceutical Industry - A Case Study

    NASA Astrophysics Data System (ADS)

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

    2016-07-01

    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.

  3. Halal pharmaceutical industry: opportunities and challenges.

    PubMed

    Nor Norazmi, Mohd; Lim, Li Sze

    2015-08-01

    The expanding global Muslim population has increased the demand for halal pharmaceuticals. However, there are several challenges for this emerging niche industry, foremost of which is the need to establish a proper, well-regulated, and harmonized accreditation and halal management system. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Pollution prevention in the pharmaceutical industry

    SciTech Connect

    Venkataramani, E.S.

    1995-09-01

    A clear understanding of the process, reaction pathways, process equipment, operational requirements, and waste stream characteristics are critical for the evaluation, selection, and implementation of pollution prevention in the pharmaceutical industry. Although pollution prevention opportunities are always preferred over treatment and disposal techniques, consideration of a full range of options--including at-source treatments and disposal--is a practical necessity to ensure protection of the environment using best available technology. General housekeeping can also play a major role in waste minimization. Waste minimization and pollution prevention are not new concepts for the pharmaceutical industry. But the confidential and highly competitive nature of the business stands in the way of disseminating information regarding specific activities in this area. The pharmaceutical industry could probably do much better in this respect. Successful implementation of waste minimization in the pharmaceutical industry requires that a process modification not have a negative impact on product quality. Recovered and recycled materials must meet quality specifications that are similar to those for virgin raw materials.

  5. An overview of the pharmaceutical industry.

    PubMed

    Stave, G M; Joines, R

    1997-01-01

    The research-based pharmaceutical industry is a large and diverse worldwide employer. Rapid changes in the health care marketplace have resulted in many changes for the industry, including a need to streamline the drug discovery and development process. To address this challenge, new technologies have been rapidly adapted. Another result of the changing marketplace has been a rapid consolidation with many recent mergers and acquisitions as well as internal reorganizations to better support new and varied customers.

  6. Effective executive management in the pharmaceutical industry.

    PubMed

    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

  7. Continuing medical education and pharmaceutical industry.

    PubMed

    Vakani, Farhan Saeed; Jafri, Wasim; Amin, Almas; Sheerani, Mughis

    2011-06-01

    Continuing medical education providers' (academia) and industrial relationship is drawing attention all over the world. To date, there are no national commercial support guidelines available in Pakistan to properly regulate cooperation between the two distinct entities. However, the fact is that the future of all continuing medical education depends on pharmaceutical support and the providers are heavily dependent on the pharmaceutical industry to remain in action. It should always be remembered that medical education and profession is regarded as a moral of enterprise based on a blind faith between the physician and the patient. The funding support by the industry should not bind or influence physician's prescription for any reason. To be trusted, medicine must be free of all such dependency; it should be accountable only to the society it serves and to its own professional standards.

  8. Globalization in the pharmaceutical industry, Part I.

    PubMed

    Casadio Tarabusi, C; Vickery, G

    1998-01-01

    This report on the pharmaceutical industry will be published in two parts. Part I begins with a summary of the study and its conclusions. The authors then provide an overview of the characteristics of the industry and current trends in its growth and structure: production and consumption, employment, research and development, capital investment, firm and product concentration and product competition, and pricing. A discussion of international trade follows, covering intra- and inter-regional, intra-firm, and intra-industry trade. The report will continue in the next issue of the Journal (Part II) with a look at foreign direct investment, inter-firm networks, and governmental policies.

  9. Organic solvents in the pharmaceutical industry.

    PubMed

    Grodowska, Katarzyna; Parczewski, Andrzej

    2010-01-01

    Organic solvents are commonly used in the pharmaceutical industry as reaction media, in separation and purification of synthesis products and also for cleaning of equipment. This paper presents some aspects of organic solvents utilization in an active pharmaceutical ingredient and a drug product manufacturing process. As residual solvents are not desirable substances in a final product, different methods for their removal may be used, provided they fulfill safety criteria. After the drying process, analyses need to be performed to check if amounts of solvents used at any step of the production do not exceed acceptable limits (taken from ICH Guideline or from pharmacopoeias). Also new solvents like supercritical fluids or ionic liquids are developed to replace "traditional" organic solvents in the pharmaceutical production processes.

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

    PubMed

    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.

  11. Mergers and innovation in the pharmaceutical industry.

    PubMed

    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.

  12. Globalization in the pharmaceutical industry, Part II.

    PubMed

    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.

  13. [Clinical researchers and pharmaceutical industry. Dangerous liaisons].

    PubMed

    Roos, J C

    1999-08-07

    Pharmaceutical industry and physician-investigators are mutually dependent for the development of new drugs and clinical trials of such drugs. Under pressure of increasing market orientation, clinical scientific investigations shift more and more from fundamental to clinical drug trials, the results of which sometimes do not justify the excitement with which they are presented in the scientific and lay press. More room and means should be given to less market oriented studies, addressing more fundamental clinical problems. Financial affiliation with the industry may influence the doctors' mind and the presentation and type of investigation. Apart from this type of intellectual subjection there is a form of financial subjugation of doctors to the industry, by participating in so-called 'postmarketing surveillance studies' which they in fact are not, that have no scientific value whatsoever, but only serve the financial interest of the participating doctor and the industry.

  14. The changing role of quality assurance in the pharmaceutical industry.

    PubMed

    Kieffer, Robert G

    2014-01-01

    ICH Q10. Pharmaceutical Quality System emphasizes that senior management is responsible for the quality system. Thus, it is not the quality assurance organization that has the primary responsibility for the quality system. With this shift of responsibilities, what can quality assurance do to help senior management fulfill their responsibility? How can quality assurance be more proactive, add more value? What new skills does quality assurance need to have in order to perform its new role? This article attempts to answer these questions.

  15. Coenzyme q 10 : a review.

    PubMed

    Singh, Deependra; Jain, Vandana; Saraf, Swarnlata; Saraf, S

    2002-10-01

    Ubiquinone or Co Q(10) is essentially a vitamin like substance and is a cofactor of an enzyme. It is an integral part of the memberanes of mitocondria where it is involved in the energy production. It is a nutrient necessary for the function of every cell of the body especially vital organs of the body like heart, liver, brain etc. Studies have shown that coenzyme Q(10) alters the natural history of cardiovascular illness and has the potential of prevention of cardiovascular diseases through the inhibition of LDL cholesterol oxidation by maintenance of optimal cellular and mitochondrial function throughout the ravages of time internal and external stress.

  16. COENZYME Q 10 : A REVIEW

    PubMed Central

    Singh, Deependra; Jain, Vandana; Saraf, Swarnlata; Saraf, S

    2002-01-01

    Ubiquinone or Co Q10 is essentially a vitamin like substance and is a cofactor of an enzyme. It is an integral part of the memberanes of mitocondria where it is involved in the energy production. It is a nutrient necessary for the function of every cell of the body especially vital organs of the body like heart, liver, brain etc. Studies have shown that coenzyme Q10 alters the natural history of cardiovascular illness and has the potential of prevention of cardiovascular diseases through the inhibition of LDL cholesterol oxidation by maintenance of optimal cellular and mitochondrial function throughout the ravages of time internal and external stress. PMID:22557086

  17. TDR collaboration with the pharmaceutical industry.

    PubMed

    Gutteridge, W E

    2006-12-01

    TDR's research programme was initiated in 1976 at the same time that the pharmaceutical industry began to withdraw from the discovery and development of new drugs for tropical diseases. TDR collaborated with the industry right from the start, its prime objective initially being to ensure that candidate drugs already in the development pipeline, such as praziquantel, mefloquine, ivermectin, halofantrine and atovaquone/proguanil, were not shelved. It became clear during the 1980s that once candidate drugs in these existing pipelines had been processed, that would be it. TDR therefore developed a number of other ways for collaboration, including testing compounds already in development in companies for other therapeutic areas. One candidate identified in this way was an oral formulation of miltefosine, in development in Asta Medica for an antitumour indication. A joint Asta Medica (later Zentaris)/TDR development project was agreed, and despite its fair share of traumas during the development process, miltefosine is now registered for the treatment of visceral leishmaniasis in India, Germany and Colombia. This example of a successful TDR/pharmaceutical industry collaboration lives on in the various Public Private Partnerships such as the new Medicines for Malaria Venture that TDR helped to spawn.

  18. Academic psychiatry and the pharmaceutical industry.

    PubMed

    Ban, Thomas A

    2006-05-01

    In the second half of the 19th century new drugs introduced by the pharmaceutical industry helped lead to the establishment of academic departments in psychiatry. Causal treatment of cerebral pellagra by nicotinic acid and cerebral syphilis by penicillin in the first half of the 20th century led to major changes in the diagnostic distribution of psychiatric patients. In the second half of the 20th century with the introduction of a rapidly growing number of psychotropic drugs, pharmacotherapy became the primary form of treatment in mental illness. Psychiatrists today perceive neuropharmacology as one of the basic sciences of psychiatry and psychopharmacology as the bridge between the mode of action and the clinical indications of psychotropic drugs. Pharmacotherapy with psychotropic drugs focused attention on the differential responsiveness to the same drug within the same diagnostic category. Yet, instead of re-evaluating psychiatric nosology and conducting research in psychopathology, a statistical methodology was adopted for the demonstration of therapeutic effectiveness in pharmacologically heterogeneous populations. Employment of consensus-based classifications and psychiatric rating scales in the clinical development of psychotropic drugs led to semi-finished products, which are prescribed indiscriminately. Replacement of single-center clinical trials by multi-center centrally coordinated clinical investigations led to the control of education in pharmacotherapy by the pharmaceutical industry. To separate education from marketing, the identification of the treatment-responsive forms of illness and the delineation of the therapeutic profile of psychotropic drugs are proposed with the employment of a new methodology, the "Composite Diagnostic Evaluation System." It is postulated that development of a pharmacologically valid psychiatric nosology with the employment of a "nosologic matrix" would provide the pharmaceutical industry with the necessary feedback to

  19. Pharmaceutical industry exposure in our hospitals: the final frontier.

    PubMed

    Dean, Jessica; Loh, Erwin; Coleman, Justin J

    2016-01-18

    Despite recent changes in attitudes, most hospitals continue to experience pharmaceutical industry presence. Pharmaceutical industry presence may be necessary and beneficial in the context of sponsorship of clinical trials with appropriate governance. Doctors continue to hold positive attitudes towards market-oriented activities of the pharmaceutical and medical device industries. Despite evidence to the contrary, doctors believe they are able to effectively manage pharmaceutical sales representative interactions such that their own prescribing is not adversely impacted. Doctors also share a belief that small gifts and benefits are harmless. There may be significant financial burden associated with divestment of such sponsorship by hospitals. Change requires education and effective policies to manage pharmaceutical industry relationships and conflicts of interest. We discuss case studies involving students and public hospital doctors to show that divestment is possible without significant financial detriment. Health services need to be proactive in transitioning financial and cultural reliance on pharmaceutical industry sponsorship to other potentially less harmful sources.

  20. Coenzyme Q10 - A new player in the treatment of heart failure?

    PubMed

    Jankowski, Jerzy; Korzeniowska, Katarzyna; Cieślewicz, Artur; Jabłecka, Anna

    2016-10-01

    Coenzyme Q10 is the only endogenously synthesized lipid with a redox function which exhibits broad tissue and intracellular distribution in mammals. Beneficial effects of Coenzyme Q10 supplementation were observed in several age-related diseases including heart failure. CoQ10 (coenzyme Q10) level is significantly decreased in patients with this disease, which correlates with severity of clinical symptoms. Supplementation with various pharmaceutical formulations of CoQ10 improves impaired cardiac function and clinical course of heart failure. Current data from clinical trials indicate that CoQ10 can significantly reduce morbidity and mortality of heart failure patients in addition to guideline recommended pharmacotherapy.

  1. The pharmaceutical industry as a medicines provider.

    PubMed

    Henry, David; Lexchin, Joel

    2002-11-16

    Rising prices of medicines are putting them beyond the reach of many people, even in rich countries. In less-developed countries, millions of individuals do not have access to essential drugs. Drug development is failing to address the major health needs of these countries. The prices of patented medicines usually far exceed the marginal costs of their production; the industry maintains that high prices and patent protection are necessary to compensate for high development costs of innovative products. There is controversy over these claims. Concerns about the harmful effects of the international system of intellectual property rights have led the World Trade Organization to relax the demands placed on least developed countries, and to advocate differential pricing of essential drugs. How these actions will help countries that lack domestic production capacity is unclear. Better access to essential drugs may be achieved through voluntary licensing arrangements between international pharmaceutical companies and manufacturers in developing countries.

  2. A vision of the pharmaceutical industry.

    PubMed

    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.

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

    PubMed

    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.

  4. Phytotoxicity of composted herbal pharmaceutical industry wastes.

    PubMed

    Suthar, Surindra; Singh, Deepika

    2011-08-01

    This work demonstrates the phytotoxicity screening of composted herbal pharmaceutical industry waste (HPIW) using seed bioassay method. The composted industrial waste should be tested at lab scale prior to recommendation for land application. HPIW was mixed with soil to produce four treatments: T(1) (1:1), T(2) (1:2), T(3) (1:3), and T(4) (1:0) for toxicity screening using Pisum sativum seeds. After 72 h relative seed germination (RSG), relative root growth (RRG) and germination index (GI) were recorded. Seedlings were observed for further plant growth and tissue biochemistry (chlorophyll, soluble sugar, starch, carotenoid, and protein) estimation. RSG, RRG, and GI values were better in T(1) and T(2) than others. GI was in the ranges of 36.62 % (T(4)) to 170.38 % (T(2)). The seedling growth and biochemical parameters were better in seedling obtained from potting media containing low proportion of HPIW (i.e., T(1) and T(2)). Results clearly suggested that composted HPIW may be utilized effectively for crop production after dilution under sustainable farming system program.

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

    NASA Astrophysics Data System (ADS)

    Sadat, Theo; Malcolm, Fiona

    2005-10-01

    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.

  6. Global gene mining and the pharmaceutical industry

    SciTech Connect

    Knudsen, Lisbeth E.

    2005-09-01

    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

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

    PubMed

    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.

  8. The importance of the pharmaceutical industry to the UK economy.

    PubMed

    Earl-Slater, A

    1998-01-01

    The objective of this paper is to indicate the importance of the pharmaceutical industry to the UK economy. Data on various aspects of the industry are presented and examined. As background information a collection of policies and pressures on the pharmaceutical environment are identified and discussed. The evidence shows what the UK economy stands to lose if it loses its pharmaceutical industrial base. Concludes that policy and pressure affecting drug products also affect drug companies; some of this is not realised when drug product policies are considered; the people of the UK will still need drugs whether or not the UK has a pharmaceutical base; the UK economy stands to lose a significant amount of benefits if it loses its pharmaceutical industrial base.

  9. [Justice challenges of pharmaceutical industry global research].

    PubMed

    Páez Moreno, Ricardo

    2010-01-01

    International research projects sponsored by the pharmaceutical industry are a recent modality of biomedical research, which is driven by interests that are not only scientific, but also commercial. This combination of interests is one of the natural consequences of globalization, which has brought unquestionable benefits for the world, but has also created a wider gap between the wealthy and the poor. Given that globalization has been led by the the world's leading economies, the level of injustice in the world has increased, often to the favor of the already wealthy. Globalization has a well-established dynamics, whose main characteristic is domain over the following: technological innovation, the organization of the production of goods and services, human needs, and consumption. International biomedical research fits well in this dynamics, and the result is often a poor distribution of benefits, added to a loss of scientific integrity for the sake of commercial interests. This phenomenon raises many ethical questions and it demands a reflection from different bioethical points of view, particularly an economic ethics and a global justice.

  10. [Relationship between pharmaceutical industry and public health in vaccination].

    PubMed

    Gervasi, Giuseppe; Capanna, Alessandra; Soncini, Renato; Zaratti, Laura; Franco, Elisabetta

    2015-01-01

    Vaccines play the main role in primary prevention in Public Health as they allow the control of many infectious diseases progression, reducing complications, morbidity and mortality. Pharmaceutical industry has spread worldwide the production and distribution of vaccines; moreover, research and new technological approaches inside industry make possible new formulations and preparations with an increasing safety. In spite of these positive aspects, lack of confidence in the utility of vaccination as well as in the real role of the pharmaceutical industry has grown in importance in recent decades. Aim of the study was to analyze these issues, with regards to cost and timing of vaccine production, and complex vaccine planning, related to efficacy, safety and tolerability assessment. Relationship between pharmaceutical industry and Public Health was finally considered; in particular, the role of Public Health as mediator between the pharmaceutical industry and the general population.

  11. Norwegian medical students' attitudes towards the pharmaceutical industry.

    PubMed

    Lea, Dordi; Spigset, Olav; Slørdal, Lars

    2010-07-01

    Whereas there is a considerable body of information on the interaction between physicians and the pharmaceutical industry, little is known about the pharmaceutical industry-medical student relationship. We have assessed the extent of contact between Norwegian medical students and the pharmaceutical industry as well as the attitudes of these students towards the pharmaceutical industry. A self-assessment questionnaire was distributed to fifth- and sixth-year students attending the four medical schools in Norway and to Norwegian medical students attending selected universities abroad. A total of 65.8% of all eligible students returned a completed questionnaire. Of these, 73.9% had been exposed to various levels of contact with the pharmaceutical industry, but only 17.5% reported having a generally positive attitude towards the industry. The level of exposure did not correlate in students' attitudes; rather, it correlated positively to a feeling of competence in terms of being able to handle such interactions. A majority of students responded that while they would decline accepting monetary gifts, they would welcome receiving reimbursements for meeting expenses, meals and educational material. Students favoured a practice of full disclosure of potential industry-related conflicts of interest among the university teaching staff. There were considerable differences in the students' attitudes between universities, suggesting that medical students are prone to influence from university lecturers. Norwegian medical students are opinionated, critical and curious with respect to pharmaceutical industry relations. This interest can be explored and probably also modified by educational initiatives.

  12. Physicians' attitudes towards interaction with the pharmaceutical industry.

    PubMed

    Alosaimi, F D; Al Kaabba, A; Qadi, M; Albahlal, A; Alabdulkarim, Y; Alabduljabbar, M; Alqahtani, F

    2015-02-02

    The relationship between physicians and the pharmaceutical industry has ethical implications for patient care. This study examined knowledge and attitudes towards the pharmaceutical industry, and associations with actual behaviour, among physicians working in Saudi Arabia. In a cross-sectional study in 2012, a 100-point score was created from 17 5-point Likert-scale questions to assess knowledge and attitudes. The overall score of 659 participants was 63.1 (SD 8.5), with a majority holding a generally positive attitude. Higher (i.e. better) scores were significantly associated with a lack of interactions with the pharmaceutical industry and with refusal of gifts but not with education about ethics. In multivariate analysis, refusing gifts, additional income and Saudi nationality remained independently associated with higher scores. Overall, there was suboptimal knowledge and a generally positive attitude towards the pharmaceutical industry among the sample of physicians in Saudi Arabia.

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

    PubMed

    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.

  14. The Utilization of Project Management in the Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Krusko, Diane; Cangemi, Robert R.

    1987-01-01

    A survey of 99 pharmaceutical companies concerning their organization and use of project management techniques for research and development found that the industry is using project management increasingly in a variety of ways for better business planning and operations. (MSE)

  15. Challenging pharmaceutical industry political power in Maine and Vermont.

    PubMed

    Castellblanch, Ramón

    2003-02-01

    A comparison of the Vermont and Maine cases of attempting to control pharmaceutical prices in the year 2000 shows that the Maine legislators were more successful in challenging pharmaceutical industry political power. This comparison shows that challenging the industry was aided by (1) mobilizing public support through grassroots organizations, (2) including independent pharmacists in negotiations over the legislation, and (3) developing state purchasing power leverage.

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

    PubMed Central

    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

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

    PubMed

    Choi, Byung Ho; Kim, Uk Hyun; Lee, Kun Soo; Ko, Cheol Woo

    2013-09-01

    45,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. Between 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. Eight 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. It 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.

  18. Clinical applications of coenzyme Q10.

    PubMed

    Garrido-Maraver, Juan; Cordero, Mario D; Oropesa-Avila, Manuel; Vega, Alejandro Fernandez; de la Mata, Mario; Pavon, Ana Delgado; Alcocer-Gomez, Elisabet; Calero, Carmen Perez; Paz, Marina Villanueva; Alanis, Macarena; de Lavera, Isabel; Cotan, David; Sanchez-Alcazar, Jose A

    2014-01-01

    Coenzyme Q10 (CoQ10) or ubiquinone was known for its key role in mitochondrial bioenergetics as electron and proton carrier; later studies demonstrated its presence in other cellular membranes and in blood plasma, and extensively investigated its antioxidant role. These two functions constitute the basis for supporting the clinical indication of CoQ10. Furthermore, recent data indicate that CoQ10 affects expression of genes involved in human cell signalling, metabolism and transport and some of the effects of CoQ10 supplementation may be due to this property. CoQ10 deficiencies are due to autosomal recessive mutations, mitochondrial diseases, ageing-related oxidative stress and carcinogenesis processes, and also a secondary effect of statin treatment. Many neurodegenerative disorders, diabetes, cancer, fibromyalgia, muscular and cardiovascular diseases have been associated with low CoQ10 levels. CoQ10 treatment does not cause serious adverse effects in humans and new formulations have been developed that increase CoQ10 absorption and tissue distribution. Oral CoQ10 treatment is a frequent mitochondrial energizer and antioxidant strategy in many diseases that may provide a significant symptomatic benefit.

  19. The extraterritoriality of US patents on the pharmaceutical industry.

    PubMed

    Park, Hyunseok

    2014-09-01

    As pharmaceutical industries have rapidly modernized and globalized, borders have been blurred and multiple entities in different countries are now involved with the manufacture, supply, distribution, dispensing and administration of even a single drug in the pharmaceutical industry. The cross jurisdictional nature of the modern pharmaceutical industry presents new challenges to limitations on the extraterritorial reach of US patents. The enforcement of US patents outside the jurisdictional boundaries of the USA has judicially evolved through cases such as Deep South, Microsoft, Bayer AG, Union Carbide, AT&T, Cardiac Pacemakers and others. This article explores the effects of recent cases on the extraterritorial enforcement of US pharmaceutical patents, particularly when different types of claims are involved.

  20. Biochemical Assessment of Coenzyme Q10 Deficiency.

    PubMed

    Rodríguez-Aguilera, Juan Carlos; Cortés, Ana Belén; Fernández-Ayala, Daniel J M; Navas, Plácido

    2017-03-05

    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.

  1. Biochemical Assessment of Coenzyme Q10 Deficiency

    PubMed Central

    Rodríguez-Aguilera, Juan Carlos; Cortés, Ana Belén; Fernández-Ayala, Daniel J. M.; Navas, Plácido

    2017-01-01

    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. PMID:28273876

  2. Biocatalysis in the Pharmaceutical Industry: The Need for Speed.

    PubMed

    Truppo, Matthew D

    2017-05-11

    The use of biocatalysis in the pharmaceutical industry continues to expand as a result of increased access to enzymes and the ability to engineer those enzymes to meet the demands of industrial processes. However, we are still just scratching the surface of potential biocatalytic applications. The time pressures present in pharmaceutical process development are incompatible with the long lead times required for engineering a suitable biocatalyst. Dramatic increases in the speed of protein engineering are needed to deliver on the ever increasing opportunities for industrial biocatalytic processes.

  3. Intellectual Property and the Pharmaceutical Scientist: An Industry Perspective.

    ERIC Educational Resources Information Center

    Reilly, William J., Jr.

    1989-01-01

    Three issues are discussed: (1) conflict between the pharmaceutical industry and academe; (2) how and why some companies contract their research efforts to colleges; and (3) how colleges can increase their percentage of industry monies available for contract research. (Author/MSE)

  4. Intellectual Property and the Pharmaceutical Scientist: An Industry Perspective.

    ERIC Educational Resources Information Center

    Reilly, William J., Jr.

    1989-01-01

    Three issues are discussed: (1) conflict between the pharmaceutical industry and academe; (2) how and why some companies contract their research efforts to colleges; and (3) how colleges can increase their percentage of industry monies available for contract research. (Author/MSE)

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

    PubMed

    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.

  6. Public perceptions of physician - pharmaceutical industry interactions: a systematic review.

    PubMed

    Arkinson, Janine; Holbrook, Anne; Wiercioch, Wojciech

    2010-05-01

    Interactions between physicians and the pharmaceutical industry have led to concerns about conflict of interest (COI), resulting in COI guidelines that suggest a threshold beyond which interactions may be considered unacceptable. Guidelines have also outlined the importance of public opinion on the topic. Consequently, we conducted a systematic review to determine the Canadian public's opinions of physician-pharmaceutical industry interactions. A systematic review of the standard health sciences literature as well as grey literature was conducted and a number of experts were contacted. Pre-determined eligibility criteria were used to identify appropriate studies. Meta-analysis of the study findings was not possible owing to the variety of methods of reporting outcomes, the types of interactions studied and the diversity of populations studied. No studies on Canadian opinions were identified. Ten international studies (n=13,637), seven with patient groups and three with public citizens, were identified that examined opinions on aspects of awareness, acceptability, disclosure and perceived effects of physician-pharmaceutical industry interactions. Heterogeneity was observed in the awareness, acceptability and perceived effects of physician-pharmaceutical industry interactions; however, there appeared to be greater acceptability and fewer perceived effects with smaller, less costly interactions that directly benefit patients or a medical practice. Desire for disclosure of these interactions was consistent across studies. Research on the public's perception of physician-pharmaceutical industry interactions has been inadequate internationally and non-existent in Canada, and is urgently needed to help shape policies regarding potential conflict of interest.

  7. Pharmaceutical Industry in Vietnam: Sluggish Sector in a Growing Market

    PubMed Central

    Angelino, Antonio; Khanh, Do Ta; An Ha, Nguyen; Pham, Tuan

    2017-01-01

    Vietnam is a fast growing economy in the Asian region with a significantly high population (over 92 million in 2015). Although still expanding (about 1.1% on average during 2000–2015), the Vietnamese population is considered to be entering the ageing stage at a very high rate. The rapid expansion of the middle-income urban class and the ageing people ratio have dramatically pushed up the demand for healthcare goods, particularly in terms of pharmaceutical products. Since the early 1990s the government has addressed the necessities of rising demand for healthcare products by formulating a series of policies aimed at promoting the development of the pharmaceutical industry. However, the implementation of such policies does not seem to have been completely efficient given that the country still needs to import up to 90% of its pharmaceutical consumption. This paper aims to explore the development of the pharmaceutical industry during the years 1990–2015 and to identify a series of weaknesses in the government promotion of the industry. Future developments will also be discussed on how the Vietnamese pharmaceutical industry could increase its participation in the regional supply chain, which is currently being dominated by big players like India and China. PMID:28850083

  8. Pharmaceutical Industry in Vietnam: Sluggish Sector in a Growing Market.

    PubMed

    Angelino, Antonio; Khanh, Do Ta; An Ha, Nguyen; Pham, Tuan

    2017-08-29

    Vietnam is a fast growing economy in the Asian region with a significantly high population (over 92 million in 2015). Although still expanding (about 1.1% on average during 2000-2015), the Vietnamese population is considered to be entering the ageing stage at a very high rate. The rapid expansion of the middle-income urban class and the ageing people ratio have dramatically pushed up the demand for healthcare goods, particularly in terms of pharmaceutical products. Since the early 1990s the government has addressed the necessities of rising demand for healthcare products by formulating a series of policies aimed at promoting the development of the pharmaceutical industry. However, the implementation of such policies does not seem to have been completely efficient given that the country still needs to import up to 90% of its pharmaceutical consumption. This paper aims to explore the development of the pharmaceutical industry during the years 1990-2015 and to identify a series of weaknesses in the government promotion of the industry. Future developments will also be discussed on how the Vietnamese pharmaceutical industry could increase its participation in the regional supply chain, which is currently being dominated by big players like India and China.

  9. Coenzyme Q10 and male infertility.

    PubMed

    Balercia, G; Mancini, A; Paggi, F; Tiano, L; Pontecorvi, A; Boscaro, M; Lenzi, A; Littarru, G P

    2009-07-01

    We had previously demonstrated that Coenzyme Q10 [(CoQ10) also commonly called ubiquinone] is present in well-measurable levels in human seminal fluid, where it probably exerts important metabolic and antioxidant functions; seminal CoQ10 concentrations show a direct correlation with seminal parameters (count and motility). Alterations of CoQ10 content were also shown in conditions associated with male infertility, such as asthenozoospermia and varicocele (VAR). The physiological role of this molecule was further clarified by inquiring into its variations in concentrations induced by different medical or surgical procedures used in male infertility treatment. We therefore evaluated CoQ10 concentration and distribution between seminal plasma and spermatozoa in VAR, before and after surgical treatment, and in infertile patients after recombinant human FSH therapy. The effect of CoQ10 on sperm motility and function had been addressed only through some in vitro experiments. In two distinct studies conducted by our group, 22 and 60 patients affected by idiopathic asthenozoospermia were enrolled, respectively. CoQ10 and its reduced form, ubiquinol, increased significantly both in seminal plasma and sperm cells after treatment, as well as spermatozoa motility. A weak linear dependence among the relative variations, at baseline and after treatment, of seminal plasma or intracellular CoQ10, ubiquinol levels and kinetic parameters was found in the treated group. Patients with lower baseline value of motility and CoQ10 levels had a statistically significant higher probability to be responders to the treatment. In conclusion, the exogenous administration of CoQ10 increases both ubiquinone and ubiquinol levels in semen and can be effective in improving sperm kinetic features in patients affected by idiopathic asthenozoospermia.

  10. Do gifts from the pharmaceutical industry affect trust in physicians?

    PubMed

    Green, Michael J; Masters, Rebecca; James, Benjamin; Simmons, Bree; Lehman, Erik

    2012-05-01

    Gifts to physicians from the pharmaceutical industry are receiving increased scrutiny, but no previous research has evaluated the effect of such gifts on trust. The goal of this study is to determine patient awareness of interactions between physicians and the pharmaceutical industry and to learn whether those interactions impact trust and the doctor-patient relationship. A cross-sectional, self-administered 61-item survey was administered in five outpatient clinic waiting rooms at a US medical center in 2008. A total of 220 consecutive English-speaking adults were invited to participate. Main outcome measures included: (1) Awareness of physician relationship with the pharmaceutical industry, (2) Attitudes about physician acceptance of gifts, (3) Perceived impact of gifts on trust in physicians, and (4) Effect of gifts on intent to adhere to physician recommendations. A total of 192 individuals participated (87% response rate). While most were unaware of particular interactions between physicians and the pharmaceutical industry (12% to 60%, depending on activity), approximately half (51%) wanted to know if their physician accepted gifts >$100. A majority indicated they would have less trust in their physician if they learned he or she: accepted gifts >$100 (59%) or went on industry-sponsored trips (58%) or sporting events (54%). Further, 25% said they would be less likely to take a prescribed medication if their physician had recently accepted a gift in return for listening to a pharmaceutical representative's presentation about that drug. Accepting gifts from the pharmaceutical industry has implications for the doctor-patient relationship. Doing so can undermine trust and affect patients' intent to adhere to medical recommendations.

  11. Drug discovery in pharmaceutical industry: productivity challenges and trends.

    PubMed

    Khanna, Ish

    2012-10-01

    Low productivity, rising R&D costs, dissipating proprietary products and dwindling pipelines are driving the pharmaceutical industry to unprecedented challenges and scrutiny. In this article I reflect on the current status of the pharmaceutical industry and reasons for continued low productivity. An emerging 'symbiotic model of innovation', that addresses underlying issues in drug failure and attempts to narrow gaps in current drug discovery processes, is discussed to boost productivity. The model emphasizes partnerships in innovation to deliver quality products in a cost-effective system. I also discuss diverse options to build a balanced research portfolio with higher potential for persistent delivery of drug molecules.

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

    PubMed

    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.

  13. Evolving role of pharmaceutical physicians in the industry: Indian perspective.

    PubMed

    Patil, Anant; Rajadhyaksha, Viraj

    2012-01-01

    The Indian pharmaceutical industry, like any other industry, has undergone significant change in the last decade. The role of a Medical advisor has always been of paramount importance in the pharmaceutical companies in India. On account of the evolving medical science and the competitive environment, the medical advisor's role is also increasingly becoming critical. In India, with changes in regulatory rules, safety surveillance, and concept of medical liaisons, the role of the medical advisor is evolving continuously and is further likely to evolve in the coming years in important areas like health economics, public private partnerships, and strategic planning.

  14. Models for open innovation in the pharmaceutical industry.

    PubMed

    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.

  15. Evolving role of pharmaceutical physicians in the industry: Indian perspective

    PubMed Central

    Patil, Anant; Rajadhyaksha, Viraj

    2012-01-01

    The Indian pharmaceutical industry, like any other industry, has undergone significant change in the last decade. The role of a Medical advisor has always been of paramount importance in the pharmaceutical companies in India. On account of the evolving medical science and the competitive environment, the medical advisor's role is also increasingly becoming critical. In India, with changes in regulatory rules, safety surveillance, and concept of medical liaisons, the role of the medical advisor is evolving continuously and is further likely to evolve in the coming years in important areas like health economics, public private partnerships, and strategic planning. PMID:22347701

  16. Medical education and the pharmaceutical industry.

    PubMed

    Goodman, Robert L

    2007-01-01

    Interactions with industry begin early in medical training, and attitudes toward these interactions among students and trainees are permissive, which is not surprising given the "informal curriculum" received from peers and role models. Though the Accreditation Council on Graduate Medical Education has recommended explicit policies on interactions between trainees and industry, past studies have shown that most schools and training programs do not have such policies. Given that acceptance of gifts from industry can create conflicts of interest, that promotional information may be biased, and that non-promotional sources of prescribing information are readily available, medical schools and training programs should develop and implement explicit policies restricting interactions between trainees and industry representatives.

  17. [The pharmaceutical industry in France: the turning point of 1915].

    PubMed

    Bonnemain, Bruno

    2015-12-01

    For several convergent reasons, 1915 was a key period for the pharmaceutical industry in France. The overall realization that France was dependent on Germany for chemical and pharmaceutical products came from shortages of key drugs but also from massive use of poison gas for which France was not able to face this unexpected event. France's shortage for chemists properly trained to answer the needs of industry, the weak relationship between industry and faculty, the uncomfortable situation of specialty drugs, the regulations on patents and trademarks were many subjects of controversies which will contribute to the analysis of the source of this French dependence to Germany. It will be at the origin of new orientations after the war for the pharmaceutical industry and the French society. The objective was to be independent for drugs and consequently to resolve the identified issues, as well as to have a dynamic industrial research. The creation and development of several pharmaceutical companies after the war was a more or less direct benefit from the considerations starting in 1915.

  18. Ball or aerosol? Sin, soap and the pharmaceutical industry.

    PubMed

    Ratcliff, Eric

    2013-02-01

    The purpose of this paper is to provoke careful and continuing reconsideration of the relationship between psychiatrists and the pharmaceutical industry through historical analysis of trends in the promotion of psychotropic drugs. Psychiatrists remain concerned about the relationship of the profession with the pharmaceutical industry. From examination of my own extended experience of that relationship (including as a former Royal Australian and New Zealand College of Psychiatrists General Councilor and chair of the Clinical Practice Advisory and Ethical Practice Committees), attention is drawn to the influence of the industry on the categorization and naming of drugs, attempts to propose target disorders and the obsolescence of established agents. Caution in accepting the role of 'opinion leader' is recommended but it remains important for psychiatrists to continue to ethically engage with the industry.

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

    PubMed

    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.

  20. Writing Technical Documents for the Global Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Bonk, Robert J.

    1998-01-01

    States that technical writers in the global pharmaceutical industry write for two audiences: regulatory agencies and healthcare practitioners. Contends that information products that address these audiences must balance the competing forces of business interests, market penetration, and the cultural variables of products so tied to people's…

  1. Some statistical issues in project prioritization in the pharmaceutical industry.

    PubMed

    Senn, S

    1996-12-30

    Various aspects of portfolio management and project prioritization within the pharmaceutical industry are examined. It is shown that the cost and probability architecture of a project is a crucial aspect of its value. An appropriate simple tool for ranking projects is the Pearson index. Various difficulties are considered.

  2. Writing Technical Documents for the Global Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Bonk, Robert J.

    1998-01-01

    States that technical writers in the global pharmaceutical industry write for two audiences: regulatory agencies and healthcare practitioners. Contends that information products that address these audiences must balance the competing forces of business interests, market penetration, and the cultural variables of products so tied to people's…

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

    ERIC Educational Resources Information Center

    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…

  4. An intellectual virtue "vaccination" for physician-pharmaceutical industry interactions.

    PubMed

    Ahmadi Nasab Emran, Shahram

    2015-01-01

    The pharmaceutical industry's wide range of interactions with physicians, trainees, and other medical professionals--interactions that include information transfer and financial incentives--has been the source of undue influences, especially on physicians' prescription behavior. Current literature has mainly been focused on the financial element of these influences, and the problems in medical professional-pharmaceutical industry interactions are mainly viewed in terms of conflicts of interest. There is often the assumption that physicians are intellectually competent but biased because of financial incentives.The author rejects that assumption and proposes an alternative explanation for the observed influence of the pharmaceutical industry on physicians' behavior by emphasizing the importance of the information-transfer side of the interactions and maintaining that physicians and other medical professionals need certain intellectual virtues (i.e., competencies) to properly assess the information, which is often unreliable and biased. These virtues are necessary for the practice of modern medicine and include mindfulness, the ability to understand practical implications of newly found evidence, to consider alternative explanations of data, to recognize and correct errors, to decide on the best available evidence, and to tailor that to the needs and values of individual patients. On the basis of this view, the author recommends that the best solution for the observed problems in physician-pharmaceutical industry interactions is to "vaccinate" physicians and other medical professionals by increasing efforts to inculcate the necessary intellectual virtues early in medical education and fostering them throughout those individuals' professional lives.

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

    ERIC Educational Resources Information Center

    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…

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

    PubMed

    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.

  7. Pharmaceutical Industry and Trade Liberalization Using Computable General Equilibrium Model

    PubMed Central

    Barouni, M; Ghaderi, H; Banouei, AA

    2012-01-01

    Background 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. Methods: 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. Results: 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. Conclusion: 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. PMID:23641393

  8. Premedical students' exposure to the pharmaceutical industry's marketing practices.

    PubMed

    Hodges, Laura E; Arora, Vineet M; Humphrey, Holly J; Reddy, Shalini T

    2013-02-01

    Physicians' exposure to pharmaceutical industry marketing raises concerns about their ability to make unbiased, evidence-based prescription decisions. This exposure begins early in medical education. The authors examined the frequency and context of such exposures for students before matriculation to medical school. The authors distributed two separate but related questionnaires to all 389 students who matriculated at the University of Chicago Pritzker School of Medicine between 2007 and 2010. The survey inquired about interactions with the pharmaceutical industry before entering medical school. Descriptive statistics and Wilcoxon rank sum tests were used to analyze data. Across four years, 282 (72.5%) students responded to the first survey; 219 (56.3%) responded to the follow-up survey. The majority of those (62.1%) had interacted with or were exposed to pharmaceutical marketing before medical school. The most common interactions were accepting a pen (50.2%) and attending a sponsored lunch (37.9%), which occurred most commonly while shadowing (33.6% and 42.2%, respectively). The next most common interactions were receiving a small gift (24.7%) and attending a sponsored dinner (20.6%), which occurred most commonly in "other" contexts, such as through family and while working in a medical setting (48.2% and 48.9%, respectively). The majority of students had interacted with the pharmaceutical industry before medical school. The differences in context indicate that students enter medical school with a heterogeneous set of exposures to pharmaceutical marketing. Medical schools should consider interventions to enhance students' knowledge of the impact of pharmaceutical marketing on physicians' prescribing practices.

  9. Quality in the pharmaceutical industry – A literature review

    PubMed Central

    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

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

    PubMed

    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. The ethics of pharmaceutical industry relationships with medical students.

    PubMed

    Rogers, Wendy A; Mansfield, Peter R; Braunack-Mayer, Annette J; Jureidini, Jon N

    2004-04-19

    Little research has been done on the extent of the relationship between the pharmaceutical industry and medical students, and the effect on students of receiving gifts. Potential harms to patients are documented elsewhere; we focus on potential harms to students. Students who receive gifts may believe that they are receiving something for nothing, contributing to a sense of entitlement that is not in the best interests of their moral development as doctors. Alternatively, students may be subject to recognised or unrecognised reciprocal obligations that potentially influence their decision making. Medical educators have a duty of care to protect students from influence by pharmaceutical companies.

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

    PubMed

    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.

  13. Pharmaceutical and industrial protein engineering: where we are?

    PubMed

    Amara, Amro Abd-Al-Fattah

    2013-01-01

    The huge amount of information, the big number of scientists and their efforts, labs, man/hrs, fund, companies all and others factors build the success of the amazing new branch of genetic engineering the 'protein engineering' (PE). It concerns with the modification of protein structure/function(s) or building protein from scratch. The engineered proteins usually have new criteria(s). Engineering proteins can be mediated on the level of genes or proteins. PE fined its way in different important sectors including industrial, pharmaceutical and medicinal ones. Aspects about PE and its applications will be discussed with this review. The concept, tools, and the industrial applications of the protein, engineered proteins and PE will be under focus. In order to get up to date knowledge about the applications of PE in basic protein and molecular biology, several examples are discussed. PE can play a significant role in different industrial and pharmaceutical sectors if used wisely and selectively.

  14. India's pharmaceutical industry: hype or high tech take-off?

    PubMed

    Malhotra, Prabodh; Lofgren, Hans

    2004-11-08

    India has built a large pharmaceutical industry through an array of measures in support of domestic firms. The absence of product patents enabled Indian companies to become world leading producers of generic versions of patented drugs. Low costs and a strong engineering tradition continue to sustain competitive strength. The implementation of the World Trade Organization patent regime in 2005 is driving a transformation of the industry. Key elements of the present shake-up include the return of 'big pharma' companies on a large scale and the emergence of several Indian firms that aim to become fully-fledged research-based multinationals. This article provides a description of the development and structure of the Indian pharmaceutical industry and explores questions and challenges arising from its integration into global markets.

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

    PubMed

    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.

  16. Measuring US pharmaceutical industry R&D spending.

    PubMed

    Golec, Joseph; Vernon, John

    2008-01-01

    Government policy debates on pharmaceutical pricing often turn on whether higher drug prices fund greater company-financed R&D spending. In the US, debate breaks down because each side uses a different measure of R&D spending, and the measures are far apart. Government agencies, Congress and consumer groups use government-generated survey data from the National Science Foundation (NSF), and the pharmaceutical industry uses survey data from the Pharmaceutical Research and Manufacturers of America (PhRMA). This issue is also relevant to academic work because some studies use NSF data, and others use PhRMA data. This article illustrates the pros and cons of these survey data series, and offers a more reliable, comprehensive and replicable alternative series, based on Compustat data.

  17. Challenges faced by the pharmaceutical industry: training graduates for employment in pharmaceutical R&D.

    PubMed

    Mooney, K G

    2001-02-01

    There is a shortfall between output from universities and demand by the pharmaceutical and health care industries for science and engineering graduates able to rapidly contribute to success in the business environment. Against a changing infrastructure of pharmaceutical research, the development of new chemical entities by major companies accounts for a high proportion of R&D expenditure. Allocation of staff is divided fairly evenly between discovery, non-clinical and clinical research activities and in all categories the new sciences are likely to be used extensively. In dealing with the shortfall the challenge comes from balancing education in basic science with training in the emerging areas of science and technology. There is a need for a 'partnership' that includes not only industry and academia but also government, since these three bodies have both synergistic and diverging interests in scientific education. On the education-training continuum, industry should recognise what it most values from academia and provide as much input and support as possible. At the same time universities must question their ability to fulfil their traditional educational role in the face of current rates of adoption of new sciences and technology. While disciplinary excellence remains vital for PhD students, multi-disciplinary programmes are becoming increasingly important to enable graduates to function effectively in the modern, globalised pharmaceutical industry.

  18. Acquainting veterinary students with careers in the pharmaceutical industry.

    PubMed

    McGregor, Douglas D; Fraser, David R; Haven, Michelle L; Hickey, Gerard J

    2007-01-01

    Careers in the pharmaceutical industry were revealed in modules facilitated by senior scientists from companies that sponsor the Cornell Leadership Program for Veterinary Students. One module was structured as a series of interviews for different positions in industry, the other as a competition between hypothetical companies created by students. The interview-based module stimulated wide-ranging discussion of the activities and responsibilities of veterinarians employed in a discovery-intensive pharmaceutical firm and of the characteristics such companies seek in prospective employees, from both professional and personal perspectives. The second module explored the drug discovery and development process from the perspective of animal-health companies that are competitors in the market for animal health care products. The exercise provided insights into the manner in which companies discover new chemical entities, screen candidate drugs, allocate resources, and pursue the development of products through testing, licensing, and distribution.

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

    PubMed

    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.

  20. [Morbidity patterns of workers employed in pharmaceutical-chemical industry].

    PubMed

    Milovanović, Aleksandar; Jakovljević, Branko; Milovanović, Jovica; Paunović, Katarina; Ilić, Dragan; Torbica, Nikola; Corac, Aleksandar; Samardzic, Svetomir; Blagojević, Tatjana

    2007-01-01

    Work in pharmaceutical-chemical industry is characterized by exposure to numerous hazards, both physical (microclimate, illumination, noise) and chemical (organic solvents). Organic solvents can cause damage to many organic systems and have carcinogenic, teratogenic and mutagenic effects. The aim of this study was to analyze patterns of chronic morbidity of workers employed in pharmaceutical-chemical industry during 2002. The study was conducted in the pharmaceutical-chemical industry "Zdravlje" Leskovac in 2002. A total of 143 workers in workplaces with special working conditions exposed to chemical hazards as well as 40 workers from control group took part in the study. The physical examinations of the participants were performed at the Department of Occupational Health in Health Center, Leskovac. Heart diseases were the most frequent both among exposed workers (17.8%) and in control group (33.3%). Respiratory diseases were at the second place (16.9% in the exposed group, and 7.4% in control group). Arterial hypertension was diagnosed in 14.7% workers occupationally exposed to hazards, and in 12.5% workers from control group (p > 0.05). Chronic bronchitis was diagnosed in 175% of the exposed workers and in only 5.0% of controls (p > 0.05). The highest prevalence of diseases in both groups was observed among workers aged 40-49 years, with 20-29 years of exposure working time. 73.4% of the exposed workers and 85% of control workers were capable of work (p > 0.05). Workers occupationally exposed to hazards in pharmaceutical-chemical industry have higher prevalence of various diseases compared to non-exposed workers, which can be the result of work, working conditions and work activity. Preventive measures should be directed towards the decrease of occupational hazards and unfavorable working conditions and increase of work protection. Regular physical examinations of workers are of prime importance for the prevention of occupational morbidity, traumatism and

  1. Dangerous liaisons: doctors-in-training and the pharmaceutical industry.

    PubMed

    Pokorny, A M J; Gittins, C B

    2015-10-01

    Interaction between doctors and the pharmaceutical industry is long-standing and ingrained in modern practice. Doctors-in-training are at a vulnerable stage of their careers, both in requiring knowledge and forming lasting relationships. There is evidence that limiting contact between industry and junior doctors has a positive effect on subsequent clinical behaviour. Currently in Australia, there is no limitation on pharmaceutical representatives approaching doctors-in-training, and the majority of education sessions are sponsored by pharmaceutical companies. This purposefully creates a sense of reciprocity, which may have adverse long-term consequences on attitudes, behaviours and patient care. Several guidelines exist that may assist junior doctors in navigating these potential interactions, most notably the Royal Australasian College of Physicians' own Guidelines for Ethical Relationships between Physicians and Industry. Despite this, there is no reflection of its importance or necessity within subspecialty curricula. This should be rectified, to the benefit of both the profession and public. © 2015 Royal Australasian College of Physicians.

  2. Regulatory constraints as seen from the pharmaceutical industry.

    PubMed

    Galligani, G; David-Andersen, I; Fossum, B

    2005-01-01

    In Chile, Canada, Europe, Japan, and the USA, which are the main geographical areas for fish farming of high value fish such as salmonids, sea bass, sea bream, yellowtail and catfish, vaccination has been established as an important method for the prevention of infectious diseases. To make new vaccines available to the fish farming industry, pharmaceutical companies must comply with the regulatory framework for licensing of fish vaccines, which in recent years has become more regulated. Considerable scientific and regulatory skills are thus required to develop, document and license vaccines in accordance with the requirements in the different geographical areas. International co-operation to harmonise requirements for the licensing documentation is ongoing. Even though there are obvious benefits to the pharmaceutical industry from the harmonisation process, it may sometimes impose unreasonable requirements. The regulatory framework for fish vaccines clearly has an impact on the time for bringing a new fish vaccine to the market. Several hurdles need to be passed to complete the regulatory process, i.e. obtain a licence. Fulfilment of the rather detailed and extensive requirements for documentation of the production and controls, as well as safety and efficacy of the vaccine, represent a challenge to the pharmaceutical industry, as do the different national and regional licensing procedures. This paper describes regulatory constraints related to the documentation, the licensing process, the site of production and the continuing international harmonisation work, with emphasis on inactivated conventional fish vaccines.

  3. [Pharmaceutical industry and "New German Medicine" ("Neue Deutsche Heilkunde")].

    PubMed

    Meyer, Ulrich

    2004-01-01

    THe so-called "New German Medicine", initially propagated in the health policy of the National Socialist Party, promoted greater use of phytotherapeutic and homeopathic drugs by the medical community. In response, the "Reichsfachschaft der pharmazeutischen Industrie e. V." (Association of Pharmaceutical Industry of the Reich") was obliged to pursue a carefully chosen double strategy, given that the members of the Association were both manufacturers of natural remedies and manufacturers of allopathic drugs.However, the fact that I.G. Farben completely ignored the "New German Medicine" suggests that the large chemical-pharmaceutical manufacturers did not take this policy very seriously. The only documents pertaining to increased research in the area of natural remedies stem from the medium-sized manufacturers Knoll and Schering. In the case of both companies it is noteworthy that they worked towards obtaining a scientific foundation for the developed preparates, and that they employed conventional methods of chemical analysis and proof of activity. THe growth of the classical manufacturers of natural remedies, such as the company Willmar Schwabe was, as far as any growth at all could be observed, significantly smaller than had been theoretically postulated. There is no casual relationship between any commercial success during the period in which the Nazis were in power and today's commercial prosperity.Moreover, from the viewpoint of the pharmaceutical industry, the "New German Medicine" seems to have passed its zenith before 1936, when the 4-year plan for war preparation entered into force.

  4. The US drug safety system: role of the pharmaceutical industry.

    PubMed

    Gibson, Brent R; Suh, Ryung; Tilson, Hugh

    2008-02-01

    Despite increasingly strident calls for improved drug safety in the United States, recent events underscore the continuing gap among manufacturers, regulators, patients, and physicians. In the period leading to the recent Institute of Medicine report on the future of drug safety, representatives from industry were given an opportunity to provide input into this report. In light of continuing concerns about drug safety and pending legislation, this original perspective provides an important context. This work consolidates the views of representatives of individual pharmaceutical companies; the large industry trade associations, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) and the Biotechnology Industry Association (BIO); and those of the authors with regard to the industry role of drug safety in the United States. To ensure continued protection of the public's health, manufacturers must recognize themselves as critical to ensuring safe products; maintain corporate safety functions separate from marketing functions; provide oversight by a senior medical executive; engage in structured epidemiological research, risk assessment, and risk communication; and mandate the formation and maintenance of an internal, interdisciplinary, senior level safety council. The importance of aggressive and accountable drug safety will only become more salient as the public and their elected representatives demand better accountability from industry. Individual corporations now have the opportunity to move first to counter perceptions of profit over safety and to ensure that their business practices adequately protect the public's health. Copyright 2007 John Wiley & Sons, Ltd.

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

    PubMed

    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.

  6. Generics market in Greece: the pharmaceutical industry's beliefs.

    PubMed

    Geitona, Mary; Zavras, Dimitrios; Hatzikou, Magda; Kyriopoulos, John

    2006-11-01

    The aim of this study was to investigate the beliefs and perspectives of the pharmaceutical industry on generic medication in Greece. Questionnaires were mailed to all 58 members of the Hellenic Association of Pharmaceutical Companies from November 2002 to February 2003. The response rate was 52%, namely 30 questionnaires were completed and returned. The questionnaire requested information on companies' involvement in generics, their opinion on generics' characteristics and on public policies affecting the demand and supply of generic medication. A descriptive analysis of the outcomes, that is percentage comparison through binomial tests and Fisher tests, was performed. According to our findings, 43% of the respondents were involved in the production and distribution of generics and the mean period of their involvement was 12 years. The majority of the respondents were in favor of their companies' involvement in generics, despite the relatively small market share of generics in Greece; 9.7% of total pharmaceutical market in 2003. Bearing in mind that in Greece the promotion of generics is not encouraged, pharmaceutical companies believe that the mandatory introduction of bioequivalence studies is an indirect promotional strategy towards generics. Additionally, the majority declared that their main competitive advantages are their safety, efficacy and effectiveness as well as their economic benefit to the society. Finally, the respondents expressed their preference for the introduction of pharmacoeconomic submissions for drugs' reimbursement by social insurance funds.

  7. Coenzyme Q10: Can It Prevent Statin Side Effects?

    MedlinePlus

    ... Q10: Can it prevent statin side effects? Can coenzyme Q10 reduce the risk of side effects from ... Francisco Lopez-Jimenez, M.D. At this time, coenzyme Q10 isn't universally recommended for preventing side ...

  8. Preparation and characterization of green bricks using pharmaceutical industrial wastes.

    PubMed

    Yamuna Rani, M; Bhagawan, D; Himabindu, V; Venkateswara Reddy, V; Saritha, P

    2016-05-01

    This paper reports on recycling of industrial wastes (three pharmaceutical industrial sludges) into environmental friendly value-added materials. Stabilization/Solidification (S/S or bricks) process was applied to make a safer way for the utilization of pharmaceutical waste. The additives in this study include binders (cement, lime and bentonite) and strengthening material (pulverized fuel ash (PFA), silica fume and quarry dust) was used at different compositions. Bricks were cured for 28 days, and the following analysis-like compressive strength, leachability of heavy metals, mineralogical phase identity by X-ray diffraction (XRD) spectroscopy, Fourier transform infrared spectroscopy (FTIR) and thermal behaviour by thermogravimetric-differential thermal analysis (TG-DTA) had done. All the bricks were observed to achieve the standard compressive strength as required for construction according to BIS standards. Metal concentration in the leachate has reached the dischargeable limits according to Brazilian standards. Results of this study demonstrate that production of bricks is a promising and achievable productive use of pharmaceutical sludge.

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

    PubMed

    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.

  10. Pharmaceutical industry sponsorship and research outcome and quality: systematic review

    PubMed Central

    Lexchin, Joel; Bero, Lisa A; Djulbegovic, Benjamin; Clark, Otavio

    2003-01-01

    Objective To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. Methods Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus. Results 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality. Conclusion Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias. PMID:12775614

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

    PubMed

    Delgado, Ignacio José Godinho

    2016-11-03

    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. Resumo: O artigo discute as relações entre os sistemas de saúde e a indústria farmacêutica, concentrando-se no apoio do Estado à inovação farmacêutica. Salienta as trajetórias dos Estados Unidos, Reino Unido e Alemanha, países desenvolvidos, paradigmáticos dos modernos sistemas de saúde (liberais, universais e corporativos), além do Japão, um caso de emparelhamento bem-sucedido. Também enfatiza as trajetórias de China, Índia e Brasil, países em desenvolvimento, extensos, que experimentaram diferentes estratégias de emparelhamento, dispondo de sistemas de saúde e indústrias farmacêuticas com trajetórias e perfis diversos. Finalmente, com foco nas formas estatais de apoio à pesquisa em saúde, considera os mecanismos de conexão entre os sistemas de saúde e a indústria farmacêutica, avaliando as possibilidades, no Brasil, de fortalecer uma interação virtuosa que favoreça a expansão e

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

    PubMed

    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.

  13. [Early achievements of the Danish pharmaceutical industry--3. Alfred Benzon].

    PubMed

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

    2011-01-01

    The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 3 deals with products from the company founded by Alfred Benzon in 1849. Alfred Nicolai Benzon owned the Swan Pharmacy in Copenhagen. In 1863 he started an independent company manufacturing branded pharmaceuticals, thus combining the pharmacy's activities with the wholesale business. The family owned the company until 1952, when it was converted into a foundation. After several restructuring rounds, the medicine production business continued as Benzon Pharma A/S until 1990, when Nycomed Pharma A/S bought up all the branded pharmaceuticals. As the first pharmaceutical company in Denmark, Alfred Benzon was an industrial frontrunner in the country at the time, supplying not only the domestic market but foreign markets as well. Alfred Benzon was the first Danish company to produce ether for anesthesia, and malt extract, a dietetic preparation. The high quality of both products made them valuable export articles. In the early 1890s, Alfred Benzon became the first Danish company to start the research-based production of extract of thyroid glands from slaughtered cattle. This was the beginning of a long-standing specialization in producing organotherapeutic substances from animal organs originating from Danish animal husbandry. In 1932 the company had 26 preparations of this type in its range, many of them on the market for several years. These medicine substances included iron preparations and effervescent salts followed by sulfonamides, synthetic hormones and a substance to counteract motion sickness.

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

    PubMed

    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

  15. Intellectual property rights: An overview and implications in pharmaceutical industry.

    PubMed

    Saha, Chandra Nath; Bhattacharya, Sanjib

    2011-04-01

    Intellectual property rights (IPR) have been defined as ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property. IPR provide certain exclusive rights to the inventors or creators of that property, in order to enable them to reap commercial benefits from their creative efforts or reputation. There are several types of intellectual property protection like patent, copyright, trademark, etc. Patent is a recognition for an invention, which satisfies the criteria of global novelty, non-obviousness, and industrial application. IPR is prerequisite for better identification, planning, commercialization, rendering, and thereby protection of invention or creativity. Each industry should evolve its own IPR policies, management style, strategies, and so on depending on its area of specialty. Pharmaceutical industry currently has an evolving IPR strategy requiring a better focus and approach in the coming era.

  16. Intellectual property rights: An overview and implications in pharmaceutical industry

    PubMed Central

    Saha, Chandra Nath; Bhattacharya, Sanjib

    2011-01-01

    Intellectual property rights (IPR) have been defined as ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property. IPR provide certain exclusive rights to the inventors or creators of that property, in order to enable them to reap commercial benefits from their creative efforts or reputation. There are several types of intellectual property protection like patent, copyright, trademark, etc. Patent is a recognition for an invention, which satisfies the criteria of global novelty, non-obviousness, and industrial application. IPR is prerequisite for better identification, planning, commercialization, rendering, and thereby protection of invention or creativity. Each industry should evolve its own IPR policies, management style, strategies, and so on depending on its area of specialty. Pharmaceutical industry currently has an evolving IPR strategy requiring a better focus and approach in the coming era. PMID:22171299

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

    PubMed

    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.

  18. Looking at CER from the pharmaceutical industry perspective.

    PubMed

    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.

  19. [Chapter 1. A contemporary history of the Japanese pharmaceutical industry (1980-2010). A contemporary history of the Japanese Pharmaceutical Industry (1980-2010) Task Force].

    PubMed

    2014-01-01

    This publication, commemorating the sixty years since the founding of Japan Society for the History of Pharmacy (JSHP), provides an overview of the Japanese pharmaceutical industry over a thirty-year span from 1980 to 2010. In the first section, entitled Medical Evolution: The Growth Period for Pharmaceutical Products, and the second section, "Patient-Based Medicine: The Period of Information Prioritization, the following themes are examined. Changes in Drug Pricing Policies, Promotion of Bungyō (separation of prescription from dispensing), Measures to Improve the Safety of Pharmaceutical Products; Appropriate Use of Pharmaceutical Products, Drug Discovery: Changes in Pharmaceutical Product Development and Actual Conditions in the Domestic Launch of New Medicines; Marketing (Medical Representative) Reforms, Pharmaceutical Industry Mergers and Acquisitions, Internationalization of the Pharmaceutical Industry. The following papers are provided as further references to support the conclusions made in the sections above. Changes in Japanese Drug Discovery Technologies and Drug Development. Japan's Pharmaceutical Market and Shifts in Manufacturing and Sales. Changes in Clinical Trials in Japan and Appropriate Use of Pharmaceuticals. Internationalization of the Japanese Pharmaceutical Industry.

  20. A pharmaceutical industry elective course on practice experience selection and fellowship pursuit by pharmacy students.

    PubMed

    Hartman, Rhea; Blustein, Leona; Morel, Diane; Davis, Lisa

    2014-08-15

    To design and implement 2 pharmaceutical industry elective courses and assess their impact on students' selection of advanced pharmacy practice experiences (APPEs) and pursuit of pharmaceutical industry fellowships. Two 2-credit-hour elective courses that explored careers within the prescription and nonprescription pharmaceutical drug industries were offered for second- and third-year pharmacy students in a doctor of pharmacy (PharmD) degree program. The impact of the courses on pharmacy students' pursuit of a pharmaceutical industry fellowship was evaluated based on responses to annual graduating students' exit surveys. A greater percentage (17.9%) of students who had taken a pharmaceutical industry elective course pursued a pharmaceutical industry fellowship compared to all PharmD graduates (4.8%). Of the students who enrolled in pharmaceutical industry APPEs, 31% had taken 1 of the 2 elective courses. Exposure to a pharmaceutical industry elective course within a college or school of pharmacy curriculum may increase students' interest in pursuing pharmaceutical industry fellowships and enrolling in pharmaceutical industry APPEs.

  1. A Pharmaceutical Industry Elective Course on Practice Experience Selection and Fellowship Pursuit by Pharmacy Students

    PubMed Central

    Blustein, Leona; Morel, Diane; Davis, Lisa

    2014-01-01

    Objective. To design and implement 2 pharmaceutical industry elective courses and assess their impact on students’ selection of advanced pharmacy practice experiences (APPEs) and pursuit of pharmaceutical industry fellowships. Methods. Two 2-credit-hour elective courses that explored careers within the prescription and nonprescription pharmaceutical drug industries were offered for second- and third-year pharmacy students in a doctor of pharmacy (PharmD) degree program. Results. The impact of the courses on pharmacy students’ pursuit of a pharmaceutical industry fellowship was evaluated based on responses to annual graduating students’ exit surveys. A greater percentage (17.9%) of students who had taken a pharmaceutical industry elective course pursued a pharmaceutical industry fellowship compared to all PharmD graduates (4.8%). Of the students who enrolled in pharmaceutical industry APPEs, 31% had taken 1 of the 2 elective courses. Conclusion. Exposure to a pharmaceutical industry elective course within a college or school of pharmacy curriculum may increase students’ interest in pursuing pharmaceutical industry fellowships and enrolling in pharmaceutical industry APPEs. PMID:25147398

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

    PubMed

    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

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

    PubMed

    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. Mental health nursing students' relationships with the pharmaceutical industry.

    PubMed

    Ashmore, Russell; Carver, Neil; Banks, David

    2007-08-01

    The medical profession's relationship with the pharmaceutical industry (PI) has come under increased scrutiny in recent years, however little is known on the subject in mental health nursing. The study sought to investigate: (1) the frequency of contact between mental health nursing students and PI employees; (2) students' attitudes and beliefs about their relationship with the PI; (3) the range of 'gifts', promotional items and hospitality accepted or seen in clinical environments by students in a one year period; and (4) students' attitudes to 'gifts', promotional items and hospitality offered by the industry. Employing a survey design, a 35-item questionnaire was distributed to 472 students at two universities in the UK. Data were analysed from 347 respondents by means of descriptive statistics and simple content analysis. The findings suggest that students have significant contact with the industry through one-to-one meetings with pharmaceutical representatives (PRs) and by attending events giving information on specific drugs or general mental health issues. Students also identified a number of benefits (e.g. receiving "up-to-date" information on new drugs) and problems (e.g. the potential influence exerted on practitioners to use their drugs) arising out of this contact. Most students (79.8%) had accepted some form of 'gift' from the industry but few (11.5%) believed it was unacceptable to do so. The presence of promotional items in the clinical environment was seen as advertising (84.4%) but few students (19.3%) believed clinical environment should be free of these items. Over half (57.1%) of the students believed that PRs did not always give unbiased information but thought that they and mental health nurses in general would be able to detect any bias. In parallel with medicine, the study has shown that the pharmaceutical industry has at least the potential to influence mental health nursing students. Within medicine this realisation has triggered a

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

    ERIC Educational Resources Information Center

    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…

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

    ERIC Educational Resources Information Center

    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…

  7. Preparation and physicochemical characterization of aqueous dispersions of coenzyme Q10 nanoparticles.

    PubMed

    Siekmann, B; Westesen, K

    1995-02-01

    The present study describes a novel pharmaceutical formulation of coenzyme Q10, viz. submicron-sized dispersions of the substance prepared by emulsification of molten coenzyme Q10 in an aqueous phase. Photon correlation spectroscopy reveals mean diameters of 60 to 300 nm depending on process parameters. Coenzyme Q10 nanoparticles remain stable on storage for more than 30 months. Lipophilic drugs can be incorporated into the nanoparticles demonstrating their potential use as a drug carrier system. Transmission electron micrographs of freeze-fractured replica show spherical particles with an amorphous core. Cryo-electron microscopy reveals the coexistence of small unilamellar vesicles in phospholipid stabilized dispersions. Thermoanalysis and X-ray studies indicate that the dispersed and emulsified coenzyme Q10 does not recrystallize even at 4 degrees C over 30 months. These agree with 1H NMR data which demonstrate that coenzyme Q10 molecules have a high mobility when formulated as nanoparticles and that colloidally dispersed coenzyme Q10 remains in the state of a supercooled melt. Despite the high melting point of the bulk material, coenzyme Q10 dispersions represent no suspensions but O/W emulsions according to the IUPAC definition (1).

  8. Current state of coenzyme Q(10) production and its applications.

    PubMed

    Jeya, Marimuthu; Moon, Hee-Jung; Lee, Jeong-Lim; Kim, In-Won; Lee, Jung-Kul

    2010-02-01

    Coenzyme Q(10) (CoQ(10)), an obligatory cofactor in the aerobic respiratory electron transfer for energy generation, is formed from the conjugation of a benzoquinone ring with a hydrophobic isoprenoid chain. CoQ(10) is now used as a nutritional supplement because of its antioxidant properties and is beneficial in the treatment of several human diseases when administered orally. Bioprocesses have been developed for the commercial production of CoQ(10) because of its increased demand, and these bioprocesses depend on microbes that produce high levels of CoQ(10) naturally. However, as knowledge of the biosynthetic enzymes and the regulatory mechanisms modulating CoQ(10) production increases, approaches arise for the genetic engineering of CoQ(10) production in Escherichia coli and Agrobacterium tumefaciens. This review focused on approaches for CoQ(10) production, strategies used to engineer CoQ(10) production in microbes, and potential applications of CoQ(10).

  9. Student understanding of the relationship between the health professions and the pharmaceutical industry.

    PubMed

    Monaghan, Michael S; Galt, Kimberly A; Turner, Paul D; Houghton, Bruce L; Rich, Eugene C; Markert, Ronald J; Bergman-Evans, Brenda

    2003-01-01

    Pharmaceutical sales representatives and direct-to-consumer advertising may influence physician practices, particularly prescribing. Identifying the relevant knowledge and attitudes students possess about the pharmaceutical industry may help professional curricula address these influences. To assess knowledge and attitudes toward pharmaceutical industry marketing, ethical principles guiding drug company interactions, pharmaceutical sales representatives as a source of drug information, and confidence level in addressing consumers seeking a prescription from a direct-to-consumer advertisement among senior-level medical, PharmD, and nurse practitioner students. A cross-sectional survey design was used to assess student knowledge and attitudes of four domains associated with the pharmaceutical industry. Significant deficiencies were noted in student knowledge of pharmaceutical marketing expenditures, professional ethics regarding interactions with drug companies, and accuracy of drug information from sales representatives. Health professional students' knowledge and attitudes toward the pharmaceutical industry are formed prior to graduation. Professional curricula must address the influences of sales representatives before postgraduate training.

  10. High Speed Video Applications In The Pharmaceutical Industry

    NASA Astrophysics Data System (ADS)

    Stapley, David

    1985-02-01

    The pursuit of quality is essential in the development and production of drugs. The pursuit of excellence is relentless, a never ending search. In the pharmaceutical industry, we all know and apply wide-ranging techniques to assure quality production. We all know that in reality none of these techniques are perfect for all situations. We have all experienced, the damaged foil, blister or tube, the missing leaflet, the 'hard to read' batch code. We are all aware of the need to supplement the traditional techniques of fault finding. This paper shows how high speed video systems can be applied to fully automated filling and packaging operations as a tool to aid the company's drive for high quality and productivity. The range of products involved totals some 350 in approximately 3,000 pack variants, encompassing creams, ointments, lotions, capsules, tablets, parenteral and sterile antibiotics. Pharmaceutical production demands diligence at all stages, with optimum use of the techniques offered by the latest technology. Figure 1 shows typical stages of pharmaceutical production in which quality must be assured, and highlights those stages where the use of high speed video systems have proved of value to date. The use of high speed video systems begins with the very first use of machine and materials: commissioning and validation, (the term used for determining that a process is capable of consistently producing the requisite quality) and continues to support inprocess monitoring, throughout the life of the plant. The activity of validation in the packaging environment is particularly in need of a tool to see the nature of high speed faults, no matter how infrequently they occur, so that informed changes can be made precisely and rapidly. The prime use of this tool is to ensure that machines are less sensitive to minor variations in component characteristics.

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

    PubMed

    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

  12. Multiblock PLS analysis of an industrial pharmaceutical process.

    PubMed

    Lopes, J A; Menezes, J C; Westerhuis, J A; Smilde, A K

    2002-11-20

    The performance of an industrial pharmaceutical process (production of an active pharmaceutical ingredient by fermentation, API) was modeled by multiblock partial least squares (MBPLS). The most important process stages are inoculum production and API production fermentation. Thirty batches (runs) were produced according to an experimental planning. Rather than merging all these data into a single block of independent variables (as in ordinary PLS), four data blocks were used separately (manipulated and quality variables for each process stage). With the multiblock approach it was possible to calculate weights and scores for each independent block. It was found that the inoculum quality variables were highly correlated with API production for nominal fermentations. For the nonnominal fermentations, the manipulations of the fermentation stage explained the amount of API obtained (especially the pH and biomass concentration). Based on the above process analysis it was possible to select a smaller set of variables with which a new model was built. The amount of variance predicted of the final API concentration (cross-validation) for this model was 82.4%. The advantage of the multiblock model over the standard PLS model is that the contributions of the two main process stages to the API volumetric productivity were determined.

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

    PubMed

    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.

  14. Personalized medicine: a paradigm for a sustainable pharmaceutical industry?

    PubMed

    Chackalamannil, Samuel; Desai, Manoj C

    2009-07-01

    Personalized medicine is a custom-tailored approach to patient treatment based on individual genetic traits. In personalized medicine, a patient group is characterized by a clinical biomarker that has been correlated to a differential response to drug treatment. During the past decade, several developments in the understanding of the structure and function of the human genome have occurred that bring personalized medicine closer to becoming a reality. The promise of personalized medicine lies in a clinical biomarker-driven patient stratification, and focused smaller-sized clinical trials that result in a shorter development time and reduced overall development cost. Personalized medicine has the potential to offer a new business model for the pharmaceutical industry by providing a more efficient drug discovery process with reduced cost.

  15. Managing laboratory automation in a changing pharmaceutical industry.

    PubMed

    Rutherford, M L

    1995-01-01

    The health care reform movement in the USA and increased requirements by regulatory agencies continue to have a major impact on the pharmaceutical industry and the laboratory. Laboratory management is expected to improve effciency by providing more analytical results at a lower cost, increasing customer service, reducing cycle time, while ensuring accurate results and more effective use of their staff. To achieve these expectations, many laboratories are using robotics and automated work stations. Establishing automated systems presents many challenges for laboratory management, including project and hardware selection, budget justification, implementation, validation, training, and support. To address these management challenges, the rationale for project selection and implementation, the obstacles encountered, project outcome, and learning points for several automated systems recently implemented in the Quality Control Laboratories at Eli Lilly are presented.

  16. Marketing norm perception among medical representatives in Indian pharmaceutical industry.

    PubMed

    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.

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

    PubMed

    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. Computational Chemistry in the Pharmaceutical Industry: From Childhood to Adolescence.

    PubMed

    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.

  19. What is the pharmaceutical industry doing, and what does the pharmaceutical industry want from animal science departments?

    PubMed

    Lauderdale, J W

    1999-02-01

    Perceived contemporary issues are 1) food safety and food healthfulness, 2) environment, 3) sustainability, 4) biotechnology, 5) animal well-being, 6) animals as food, and 7) research funding. Food safety is the paramount contemporary issue, and environment and sustainability issues can be considered as a single issue. Biotechnology, animal well-being, and animals as food are addressed in this paper as separate issues, but they can be considered as components of food safety and healthfulness. The pharmaceutical industry addresses these issues by providing safe and effective products to the livestock industry. These products are used to treat and prevent disease and to increase livestock production efficiency. These products contribute to a safe food supply, enhance protection of the environment, and increase the sustainability of animal agriculture through increased efficiency of livestock production. The pharmaceutical industry wants the following from animal science departments: 1) students skilled in deductive and inductive thinking and communicating to peers and the public; 2) regional research on food safety, such as irradiation, steaming of carcasses, E. coli contamination, antibiotic resistance, production facilities, and carcass contamination; 3) improved research to identify the food values of animal products and effective communication of that research to the public; 4) research on topics having the greatest potential to increase efficiency of animal production consistent with a positive impact on the environment and sustainability of animal production; 5) leadership in developing and using technologies such as biotechnology, not only as descriptors of biological processes, but as technologies to test hypotheses leading to new understandings of biology; 6) research on animal well-being and production facilities that foster animal well-being; 7) research and education on ethical and moral aspects of animals as food through encouragement of one or more

  20. Spontaneous abortions among women working in the pharmaceutical industry.

    PubMed Central

    Taskinen, H; Lindbohm, M L; Hemminki, K

    1986-01-01

    A register based study was conducted on the pregnancy outcome of female workers in eight Finnish pharmaceutical factories to determine whether they had a higher risk of spontaneous abortion than the general population or matched controls. Information about all female workers who had been employed in the factories during the years 1973 or 1975 (four factories) to 1980 was obtained from the employers. The workers' pregnancy data were collected from the nation wide hospital discharge register and polyclinic data of hospitals from 1973 to 1981. The total number of 1795 pregnancies included 1179 deliveries, 142 spontaneous abortions, and 474 induced abortions. The spontaneous abortion rate (the number of spontaneous abortions X 100, divided by the number of spontaneous abortions plus the number of births) during employment was 10.9% and before/after employment 10.6%. The rate for all the women in the corresponding central hospital districts was 11.3% [corrected] during the study period. A case-control study was also carried out in which the cases were 44 women who had a spontaneous abortion during employment in the pharmaceutical factory. Three age matched female pharmaceutical factory workers who had given birth to a child were chosen as controls for every case. The information about occupational exposures was collected from questionnaires completed by the occupational physician or nurse at the factory. The response rate was 93%. Exposure to chemicals was more common among the cases than among the controls. For methylene chloride, a solvent commonly used in the pharmaceutical industry, the increase in odds ratio of borderline significance (odds ratio 2.3, p = 0.06). In a logistic regression model (which included oestrogen exposure, solvent exposure frequency of the usage, and heavy lifting) the odds ratio was increased for oestrogens (odds ratio 4.2, p = 0.05) and for continuous heavy lifting (odds ratio 5.7, p = 0.02). The odds ratio for spontaneous abortions was

  1. Molecular diagnosis of coenzyme Q10 deficiency.

    PubMed

    Yubero, Delia; Montero, Raquel; Armstrong, Judith; Espinós, Carmen; Palau, Francesc; Santos-Ocaña, Carlos; Salviati, Leonardo; Navas, Placido; Artuch, Rafael

    2015-01-01

    Coenzyme Q10 (CoQ) deficiency syndromes comprise a growing number of neurological and extraneurological disorders. Primary-genetic but also secondary CoQ deficiencies have been reported. The biochemical determination of CoQ is a good tool for the rapid identification of CoQ deficiencies but does not allow the selection of candidate genes for molecular diagnosis. Moreover, the metabolic pathway for CoQ synthesis is an intricate and not well-understood process, where a large number of genes are implicated. Thus, only next-generation sequencing techniques (either genetic panels of whole-exome and -genome sequencing) are at present appropriate for a rapid and realistic molecular diagnosis of these syndromes. The potential treatability of CoQ deficiency strongly supports the necessity of a rapid molecular characterization of patients, since primary CoQ deficiencies may respond well to CoQ treatment.

  2. Pharmaceutical industry interactions of psychiatric trainees from 20 European countries.

    PubMed

    Riese, F; Guloksuz, S; Roventa, C; Fair, J D; Haravuori, H; Rolko, T; Flynn, D; Giacco, D; Banjac, V; Jovanovic, N; Bayat, N; Palumbo, C; Rusaka, M; Kilic, O; Augėnaitė, J; Nawka, A; Zenger, M; Kekin, I; Wuyts, P; Barrett, E; Bausch-Becker, N; Mikaliūnas, J; Del Valle, E; Feffer, K; Lomax, G A; Marques, J G; Jauhar, S

    2015-02-01

    Interactions between the pharmaceutical industry (PI) and psychiatrists have been under scrutiny recently, though there is little empirical evidence on the nature of the relationship and its intensity at psychiatry trainee level. We therefore studied the level of PI interactions and the underlying beliefs and attitudes in a large sample of European psychiatric trainees. One thousand four hundred and forty-four psychiatric trainees in 20 European countries were assessed cross-sectionally, with a 62-item questionnaire. The total number of PI interactions in the preceding two months varied between countries, with least interactions in The Netherlands (M (Mean)=0.92, SD=1.44, range=0-12) and most in Portugal (M=19.06, SD=17.44, range=0-100). Trainees were more likely to believe that PI interactions have no impact on their own prescribing behaviour than that of other physicians (M=3.30, SD=1.26 vs. M=2.39, SD=1.06 on a 5-point Likert scale: 1 "completely disagree" to 5 "completely agree"). Assigning an educational role to the pharmaceutical industry was associated with more interactions and higher gift value (IRR (incidence rate ratio)=1.21, 95%CI=1.12-1.30 and OR=1.18, 95%CI=1.02-1.37). There are frequent interactions between European psychiatric trainees and the PI, with significant variation between countries. We identified several factors affecting this interaction, including attribution of an educational role to the PI. Creating alternative educational opportunities and specific training dedicated to PI interactions may therefore help to reduce the impact of the PI on psychiatric training. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  3. Attitudes of preclinical and clinical medical students toward interactions with the pharmaceutical industry.

    PubMed

    Hyman, Paul L; Hochman, Michael E; Shaw, Jonathan G; Steinman, Michael A

    2007-01-01

    Medical school is a critical time for physicians in training to learn the professional norms of interacting with the pharmaceutical industry, yet little is known about how students' attitudes vary during the course of training. This study sought to determine students' opinions about pharmaceutical industry interactions with medical students and whether these opinions differ between preclinical and clinical students. The authors surveyed medical students at Harvard Medical School (HMS) from November 2003 through January 2004 using a six-question survey. The authors then analyzed how responses differed among the classes. Out of 723 questionnaires, 418 were returned--an overall response rate of 58%. A total of 107 (26%) students believed that it is appropriate for medical students to accept gifts from pharmaceutical companies, and 76 (18%) agreed that the medical school curriculum should include events sponsored by the pharmaceutical industry. Many students--253 (61%)--reported that they do not feel adequately educated about pharmaceutical industry-medical professionals' interactions. Preclinical and clinical students had similar opinions for the majority of their responses. Finally, students who reported feeling better educated about pharmaceutical industry interactions tended to be less skeptical of the industry and more likely to view interactions with the industry as appropriate. Students' opinions about interactions with the pharmaceutical industry were similar between preclinical and clinical students, suggesting that the current medical school experience may have limited impact on students' views about interactions with the pharmaceutical industry.

  4. [Conflict of interest regarding clinical physicians' relationship with pharmaceutical industry and medical education].

    PubMed

    Miyata, Yasushi

    2010-01-01

    The relationship between clinical physicians and the pharmaceutical industry is becoming an important social issue. Many lawsuits against drug companies in the area of psychiatric medicine have been heavily covered by the mass media in the U.S., and the injustices of drug companies and clinical physicians have been revealed in court. Although there are few such large social issues in Japan, the relationship between clinical physicians and the pharmaceutical industry in Japan appears inappropriate. A study on the relationship between Japanese clinical physicians and the pharmaceutical industry revealed that many physicians received "gifts" from pharmaceutical companies. This is one form of evidence for the inappropriate relationship between Japanese physicians and pharmaceutical industries. Recently, many recommendations to realize an appropriate relationship between physicians and the pharmaceutical industry have been published in the U.S. However, discussion concerning the relationship between clinical physicians and pharmaceutical companies in Japan is not active. We have received a lot of financial support for continuing medical education from pharmaceutical industries. Without such support, we may not be able to maintain the same level of medical education. Understanding such present conditions, we need to discuss what is an appropriate relationship between clinical physicians and the pharmaceutical industry.

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

    PubMed

    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

  6. [Organization and management of nationalized pharmaceutical industry in Slovakia from 1945 to 1948].

    PubMed

    Senček, Richard R

    2013-02-01

    The paper discusses a short but important period in the history of pharmaceutical industry with regard to Slovakia. The complicated post-war situation required peremptory interventions from the state, which attempted to secure the operation of strategic firms by means of National Administration Boards and nationalization. The firms which were nationalized by this measure were managed by the Ministry of Industry. They included also the pharmaceutical firms nationalized in Slovakia. The situation which produced contradictory responses in society and political scene culminated in the communist coup detat and nationalization of virtually all industries.Key words: nationalization pharmaceutical industry Ministry of Industry.

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

    PubMed

    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

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

    ERIC Educational Resources Information Center

    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…

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

    ERIC Educational Resources Information Center

    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…

  10. Paediatricians and the pharmaceutical industry: an industry perspective of the challenges ahead.

    PubMed

    Leather, David A; Davis, Sarah C

    2006-03-01

    The relationship between healthcare professionals and the pharmaceutical industry is under intense scrutiny. Accusations of corrupt practices have been levelled at the industry by both the professional and the lay press. The environment is changing, with rising expectations of transparency and ethical standards. In addition, society is becoming increasingly risk averse. There have been examples of poor practice by industry in the past, and industry is learning from these. Equally, there are many examples of excellent practice where industry has worked effectively and ethically with clinicians. The goal of industry is to bring new medicines to benefit patients and shareholders. Commercial success is dependent upon putting the patient at the centre of activity. It also allows re-investment into research and development. This allies industry and healthcare professionals with a common and key ethical arbitrator--the patient. Industry is changing as an acknowledgement of the need to adapt to the culture change demanded by society. Self regulation is increasingly active and transparent; guidelines, laws and internal/external regulators exist to examine industry. However, for the changes in regulations, behaviour and practices to be fully effective, there is a need for dialogue between industry and healthcare professionals. Commitment is needed from both sides to work together to manage the relationship.

  11. American Foundation for Pharmaceutical Education Survey of Scientific Manpower Needs in the Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Fisher, Albert B., Jr.

    1979-01-01

    Those disciplines in the pharmaceutical sciences where critical manpower shortages now exist or will occur are identified by 34 pharmaceutical manufacturers in response to a request by the American Foundation for Pharmaceutical Education, which awarded fellowships in four critical areas. High priority needs are appended. (JMD)

  12. Clinical aspects of coenzyme Q10: an update.

    PubMed

    Littarru, Gian Paolo; Tiano, Luca

    2010-03-01

    The fundamental role of coenzyme Q(10) (CoQ(10)) in mitochondrial bioenergetics and its well-acknowledged antioxidant properties constitute the basis for its clinical applications, although some of its effects may be related to a gene induction mechanism. Cardiovascular disease is still the main field of study and the latest findings confirm a role of CoQ(10) in improving endothelial function. The possible relation between CoQ(10) deficiency and statin side effects is highly debated, particularly the key issue of whether CoQ(10) supplementation counteracts statin myalgias. Furthermore, in cardiac patients, plasma CoQ(10) was found to be an independent predictor of mortality. Studies on CoQ(10) and physical exercise have confirmed its effect in improving subjective fatigue sensation and physical performance and in opposing exercise-related damage. In the field of mitochondrial myopathies, primary CoQ(10) deficiencies have been identified, involving different genes of the CoQ(10) biosynthetic pathway; some of these conditions were found to be highly responsive to CoQ(10) administration. The initial observations of CoQ(10) effects in Parkinson's and Huntington's diseases have been extended to Friedreich's ataxia, where CoQ(10) and other quinones have been tested. CoQ(10) is presently being used in a large phase III trial in Parkinson's disease. CoQ(10) has been found to improve sperm count and motility on asthenozoospermia. Moreover, for the first time CoQ(10) was found to decrease the incidence of preeclampsia in pregnancy. The ability of CoQ(10) to mitigate headache symptoms in adults was also verified in pediatric and adolescent populations.

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

    PubMed Central

    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

  14. [Brocades and Stheeman: from apothecary-manufacturer to pharmaceutical industry].

    PubMed

    Rinsema, T

    1999-01-01

    In the middle of the nineteenth century, vegetable products were the most important raw material for the pharmaceutical industry. That industry was a "pharmacist-industry" and the quality of their products was defined in the official pharmacopoeias. Eisso Post Stheeman was one of these pharmacists and although he was a producer of medicines he stayed a pharmacist between pharmacists. He communicated with them about the quality of medicines in terms of pureness, identity and preparation. His successor, Sypko Stheeman, went into his fathers steps. He too was primarily a pharmacist; only after that a producer of (vegetable) drugs. Still there was a difference between them. Sypko focussed more on commerce and production of medicines. To that end price-lists were published from 1878 onwards. These price-lists became an important medium of communication between manufacturer and pharmacist. The introduction of the steam engine in 1894 represents a turning-point. Steam energy made many new activities possible, and the production of medicines and dispensation forms became possible on a much larger scale. The development that had set in with the introduction of steam energy was completed in the years between 1901 and 1914. Production of medicines grew enormously, but an important renewal was the production of tablets. Millions of them left the factory in Meppel every day. At the same time, the firm strived to give each of the produced medicines its own identity. Brocades and Stheeman not only introduced "specialities", but chemical drugs, produced by others, were being marketed under the label of B S as well. Gradually, the standard of pharmacist-quality had been replaced by Broacades and Stheeman-quality.

  15. Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective.

    PubMed

    Jones, H M; Chen, Y; Gibson, C; Heimbach, T; Parrott, N; Peters, S A; Snoeys, J; Upreti, V V; Zheng, M; Hall, S D

    2015-03-01

    The application of physiologically based pharmacokinetic (PBPK) modeling has developed rapidly within the pharmaceutical industry and is becoming an integral part of drug discovery and development. In this study, we provide a cross pharmaceutical industry position on "how PBPK modeling can be applied in industry" focusing on the strategies for application of PBPK at different stages, an associated perspective on the confidence and challenges, as well as guidance on interacting with regulatory agencies and internal best practices.

  16. Marketing Norm Perception Among Medical Representatives in Indian Pharmaceutical Industry

    PubMed Central

    Nagashekhara, Molugulu; Agil, Syed Omar Syed; Ramasamy, Ravindran

    2012-01-01

    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. PMID:24826035

  17. Health Professionals "Make Their Choice": Pharmaceutical Industry Leaders' Understandings of Conflict of Interest.

    PubMed

    Grundy, Quinn; Tierney, Lisa; Mayes, Christopher; Lipworth, Wendy

    2017-09-14

    Conflicts of interest, stemming from relationships between health professionals and the pharmaceutical industry, remain a highly divisive and inflammatory issue in healthcare. Given that most jurisdictions rely on industry to self-regulate with respect to its interactions with health professionals, it is surprising that little research has explored industry leaders' understandings of conflicts of interest. Drawing from in-depth interviews with ten pharmaceutical industry leaders based in Australia, we explore the normalized and structural management of conflicts of interest within pharmaceutical companies. We contrast this with participants' unanimous belief that the antidote to conflicts of interest with health professionals were "informed consumers." It is, thus, unlikely that a self-regulatory approach will be successful in ensuring ethical interactions with health professionals. However, the pharmaceutical industry's routine and accepted practices for disclosing and managing employees' conflicts of interest could, paradoxically, serve as an excellent model for healthcare.

  18. Predicting drug efficacy: knockouts model pipeline drugs of the pharmaceutical industry.

    PubMed

    Zambrowicz, Brian P; Turner, C Alexander; Sands, Arthur T

    2003-10-01

    One of the major challenges for the pharmaceutical industry is to develop innovative drugs to new targets from the human genome. A systematic approach for target selection could significantly increase the rate of successful new drug development, thereby enhancing industry productivity. It has previously been shown that mouse knockout phenotypes for the targets of the 100 best-selling pharmaceutical drugs correlate well with known drug efficacy. Furthermore, physiological validation of novel pipeline targets of the pharmaceutical industry has been provided using mouse knockout data. These data demonstrate an excellent correlation between knockout phenotype and anticipated drug efficacy, establishing an important marker for superior new drug targets from the genome.

  19. Ways of Learning in the Pharmaceutical Sales Industry

    ERIC Educational Resources Information Center

    Hunter, Carrie Patricia

    2010-01-01

    Purpose: The purpose of this paper is to document the ways pharmaceutical representatives learn for work and report attributes of (in)formality and other characteristics of ways of learning perceived as effective and frequently used. Design/methodology/approach: A total of agents 20 from 11 pharmaceutical manufacturers across Canada participated…

  20. Ways of Learning in the Pharmaceutical Sales Industry

    ERIC Educational Resources Information Center

    Hunter, Carrie Patricia

    2010-01-01

    Purpose: The purpose of this paper is to document the ways pharmaceutical representatives learn for work and report attributes of (in)formality and other characteristics of ways of learning perceived as effective and frequently used. Design/methodology/approach: A total of agents 20 from 11 pharmaceutical manufacturers across Canada participated…

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

    PubMed

    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.

  2. American export control, technology spillover and innovation of Chinese pharmaceutical Industry.

    PubMed

    Hui, Jiang

    2017-05-01

    This paper was aimed to analyze whether the U.S. strict export control to China affects the technological innovation of Chinese pharmaceutical industry. This paper selected the data of technological innovation and the expenditure of high and new technology adoption in China's pharmaceutical industry from 1995 to 2014, created panel regression model to study the impact of export controls on technology spillovers and the impact of technology spillovers on innovation capacity. The results show that US export control has a significant impact on technology spillovers, but foreign technology spillovers have no significant impact on the innovation of Chinese pharmaceutical industry. Although the US export control prevented foreign technology spillovers to China, but indirectly stimulated the domestic technology spillovers to pharmaceutical manufacturing industry in China. Statistical analysis show that the correlation coefficient between innovation capacity and expenditure for high technology adoption is not significant, but the expenditure of purchasing domestic technical is essential to pharmaceutical innovation. This study shows that US export control indirectly, not directly, affected the technological innovation of China's pharmaceutical industry, affected the allocation of innovative resources, but failed to prevent the technological progress and competitiveness improvement of Chinese pharmaceutical industry.

  3. Pharmaceutical industry support and residency education: a survey of internal medicine program directors.

    PubMed

    Loertscher, Laura L; Halvorsen, Andrew J; Beasley, Brent W; Holmboe, Eric S; Kolars, Joseph C; McDonald, Furman S

    2010-02-22

    Interactions with the pharmaceutical industry are known to affect the attitudes and behaviors of medical residents; however, to our knowledge, a nationally representative description of current practices has not been reported. The Association of Program Directors in Internal Medicine surveyed 381 US internal medicine residency program directors in 2006-2007 regarding pharmaceutical industry support to their training programs. The primary outcome measure was program director report of pharmaceutical financial support to their residency. Demographic and performance variables were analyzed with regard to these responses. In all, 236 program directors (61.9%) responded to the survey. Of these, 132 (55.9%) reported accepting support from the pharmaceutical industry. One hundred seventy of the 236 program directors (72.0%) expressed the opinion that pharmaceutical support is not desirable. Residency programs were less likely to receive pharmaceutical support when the program director held the opinion that industry support was not acceptable (odds ratio [OR], 0.07; 95% confidence interval [CI], 0.02-0.22). Programs located in the southern United States were more likely to accept pharmaceutical support (OR, 8.45; 95% CI, 1.95-36.57). The American Board of Internal Medicine pass rate was inversely associated with acceptance of industry support: each 1% decrease in the pass rate was associated with a 21% increase in the odds of accepting industry support (OR, 1.21; 95% CI, 1.07-1.36). Although most of the program directors did not find pharmaceutical support desirable, more than half reported acceptance of industry support. Acceptance of pharmaceutical industry support was less prevalent among residency programs with a program director who considered support unacceptable and those with higher American Board of Internal Medicine pass rates.

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

    PubMed

    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

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

    PubMed

    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

  6. Challenges in Providing e-Learning Solutions in the Regulated Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Vesper, James L.

    Regulatory agencies around the world require that those involved in producing pharmaceutical products be adequately trained. E-learning can accomplish this, providing consistent delivery and learner assessment. However, there are some unique expectations that regulators and the pharmaceutical industry have of e-learning solutions. These include…

  7. Psychiatric Training Program Engagement with the Pharmaceutical Industry: An Educational Issue, Not Strictly an Ethical One

    ERIC Educational Resources Information Center

    Mohl, Paul C.

    2005-01-01

    OBJECTIVE: To analyze the educational and ethical issues involved in interactions between departments of psychiatry and the pharmaceutical industry. METHODS: The author analyzes the history of attitudes toward pharmaceutical companies, various conflicting ethical principles that apply, and areas of confluence and conflict of interest between…

  8. Psychiatric Training Program Engagement with the Pharmaceutical Industry: An Educational Issue, Not Strictly an Ethical One

    ERIC Educational Resources Information Center

    Mohl, Paul C.

    2005-01-01

    OBJECTIVE: To analyze the educational and ethical issues involved in interactions between departments of psychiatry and the pharmaceutical industry. METHODS: The author analyzes the history of attitudes toward pharmaceutical companies, various conflicting ethical principles that apply, and areas of confluence and conflict of interest between…

  9. Pharmaceutical industry discursives and the marketization of nursing work: a case example.

    PubMed

    Springer, Rusla Anne

    2011-07-01

    Increasing pharmaceutical industry presence in health care research and practice has evoked critical social, political, economic, and ethical questions and concern among health care providers, ethicists, economists, and the general citizenry. The case example presented of the 'marketization' of nursing practice not only reveals the magnitude of the purview of the pharmaceutical industry, it demonstrates how that industry imparts effect upon the organization of nursing work, an area of health care professional practice where the ethical polemic of pharmaceutical industry involvement and influence has been largely ignored, and the profession of nursing conspicuously silent. Drawing on a Foucauldian dispositive analysis that troubled the complex apparatus responsible for the production of knowledge and action in the neurology subspecialty of multiple sclerosis (MS), the case discloses how the pharmaceutical industry has created compliance and adherence as clinical imperatives in the practice of MS nursing. The case makes explicit the conscious transformative self-action undertaken by MS nurses as a result of their subjectivation (marketization) and demonstrates how MS nurses have become pawns in pharmaceutical industry strategic games of power, truth, identity, and wealth creation by turning their clinical practice settings into heterodiscursive spaces of surveillance and persuasion. MS nurses have become instruments of the pharmaceutical industry, and their clinical practices ordered, organized, limited, constrained, and marketized as a result.

  10. Optimized genotyping method for identification of bacterial contaminants in pharmaceutical industry.

    PubMed

    Stamatoski, Borche; Ilievska, Miroslava; Babunovska, Hristina; Sekulovski, Nikola; Panov, Sasho

    2016-06-01

    Microbiological control is of crucial importance in the pharmaceutical industry regarding the possible bacterial contamination of the environment, water, raw materials and finished products. Molecular identification of bacterial contaminants based on DNA sequencing of the hypervariable 16SrRNA gene has been introduced recently. The aim of this study is to investigate the suitability of gene sequencing using our selection of PCR primers and conditions for rapid and accurate bacterial identification in pharmaceutical industry quality control. DNA was extracted from overnight incubated colonies from 10 bacterial ATCC strains, which are common contaminants in the pharmaceutical industry. A region of bacterial 16SrRNA gene was analyzed by bidirectional DNA sequencing. Bacterial identification based on partial sequencing of the 16SrRNA gene is the appropriate method that could be used in the pharmaceutical industry after adequate validations. We have successfully identified all tested bacteria with more than 99 % similarity to the already published sequences.

  11. Analogies Among Current and Future Life Detection Missions and the Pharmaceutical/Biomedical Industries

    NASA Astrophysics Data System (ADS)

    Wainwright, N. R.; Steele, A.; Monaco, L.; Fries, M.

    2017-02-01

    Life detection goals and technologies are remarkably similar between several types of NASA missions and the pharmaceutical and biotechnology industries. Needs for sensitivity, specificity, speed have driven techniques and equipment to common ends.

  12. [Ethical advice regarding the relationship between psychiatrists and the pharmaceutical industry].

    PubMed

    Morrens, M; De Fruyt, J; Pattyn, T; Surmont, M; Pieters, G

    2015-01-01

    The pharmaceutical industry is an important partner in mental health care. To provide ethical advice that will help psychiatrists build a balanced relationship with the pharmaceutical industry. In this article we present the current advisory principles that have been developed by the Flemish Psychiatric Association (Vlaamse Vereniging voor Psychiatrie; VVP). Not only do we give general advice that is relevant for all psychiatrists, but we also give advice that is applicable specifically to the psychiatrist-researcher, teachers and psychiatric trainees. Finally, we explain more fully how the VVP, as an organisation, deals with these issues. It is important that the psychiatrists and the pharmaceutical industry deal with each other in a balanced and constructive manner, thereby stimulating progress in the field of psychiatry. For this purpose the VVP has formulated a number of ethical principles which, in our view, define the way in which psychiatrists should deal with the pharmaceutical industry.

  13. Pharmaceutical industry and the market: The case of Prozac and other antidepressants.

    PubMed

    Das, Anindya

    2011-03-01

    This article attempts to critically evaluate the role of the pharmaceutical industry in health care from the theoretical standpoint of 'medical-industrial complex'. The historical context of the expansion of the pharmaceutical industry is summarized followed by a critical evaluation of the methods of studying effectiveness of pharmaceutical agents and the aspects involved in reporting, publication and marketing. Further issues are elaborated with a case study of the antidepressants. The establishment of pharmaceutical industry is premised on various ethical principles and moral norms yet such guiding values are forsaken resulting in a contradictory stance where human life and suffering are devalued rather than saved and ameliorated in a bid to maximize profits. The conventional response of more stringent regulation and the broader reason of economic model of unequal power need to be reevaluated. Copyright © 2011 Elsevier B.V. All rights reserved.

  14. Coenzyme Q10 protects hair cells against aminoglycoside.

    PubMed

    Sugahara, Kazuma; Hirose, Yoshinobu; Mikuriya, Takefumi; Hashimoto, Makoto; Kanagawa, Eiju; Hara, Hirotaka; Shimogori, Hiroaki; Yamashita, Hiroshi

    2014-01-01

    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.

  15. Coenzyme Q10 and Cognition in atorvastatin treated dogs

    PubMed Central

    Martin, Sarah B.; Cenini, Giovanna; Barone, Eugenio; Dowling, Amy L.S.; Mancuso, Cesare; Butterfield, D. Allan; Murphy, M. Paul; Head, Elizabeth

    2011-01-01

    Statins have been suggested to protect against Alzheimer’s disease (AD). Recently, however, we reported that aged dogs that underwent chronic statin treatment exhibited cognitive deficits compared with age matched controls. In human studies, blood levels of Coenzyme Q10 (CoQ10) decrease with statin use. CoQ10 is important for proper mitochondrial function and is a powerful antioxidant, two important factors for cognitive health in aging. Thus, the current study tested the hypothesis that CoQ10 levels in the serum and/or parietal cortex are decreased in statin treated dogs and are associated with poorer cognition. Six aged beagles (>8 years) were administered 80 mg/day of atorvastatin for 14.5 months and compared with placebo-treated animals. As predicted, serum CoQ10 was significantly lower in statin-treated dogs. Parietal cortex CoQ10 was not different between the two groups. However, poorer cognition was correlated with lower parietal cortex CoQ10. This study in dogs suggests that serum CoQ10 is reduced with atorvastatin treatment. CoQ10 levels in brain may linked to impaired cognition in response to atorvastatin, in agreement with previous reports that statins may have a negative impact on cognition in the elderly. PMID:21763754

  16. Coenzyme Q10 Protects Hair Cells against Aminoglycoside

    PubMed Central

    Sugahara, Kazuma; Hirose, Yoshinobu; Mikuriya, Takefumi; Hashimoto, Makoto; Kanagawa, Eiju; Hara, Hirotaka; Shimogori, Hiroaki; Yamashita, Hiroshi

    2014-01-01

    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. PMID:25265538

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

    PubMed

    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.

  18. Interactions with the pharmaceutical industry: a survey of family medicine residents in Ontario.

    PubMed Central

    Sergeant, M D; Hodgetts, P G; Godwin, M; Walker, D M; McHenry, P

    1996-01-01

    OBJECTIVE: To determine the attitudes, knowledge and practices of family medicine residents relating to the pharmaceutical industry and to assess the effectiveness of existing guidelines on appropriate interactions with the pharmaceutical industry. DESIGN: Survey by mailed questionnaire. SETTING: Ontario. PARTICIPANTS: All 262 second-year family medicine residents in Ontario (seven centres); 226 (86.3%) responded. RESULTS: Fifty-two (23.0%) of the residents who responded stated that they had read the CMA policy statement on appropriate interactions between physicians and the pharmaceutical industry. A total of 124 (54.9%) stated that they would attend a private dinner paid for by a pharmaceutical representative; the proportion was not significantly reduced among those who had read the CMA guidelines, which prohibit the acceptance of personal gifts. In all, 186 (82.3%) reported that they would like the opportunity to interact with pharmaceutical representatives in an educational setting, even though several programs now discourage these interactions. Approximately three quarters (172/226 [76.1%]) of the residents indicated that they plan to see pharmaceutical representatives in their future practice. Residents at Centre 2 were significantly more critical of the pharmaceutical industry than those from the other centres. Overall, being aware of, and familiar with, departmental policy or CMA policy on interactions with the pharmaceutical industry did not affect the residents' attitudes or intended future practices. CONCLUSION: The presence of guidelines concerning physicians' interactions with the pharmaceutical industry does not appear to have a significant impact on family medicine residents in Ontario. PMID:8911290

  19. Interactions of staff and residents with pharmaceutical industry: a survey of psychiatric training program policies.

    PubMed

    Chakrabarti, A; Fleisher, W P; Staley, D; Calhoun, L

    2002-12-01

    In response to perceived controversies regarding interactions between physicians and the pharmaceutical industry, we undertook a study to look at the relationship between Canadian psychiatry training programs and the pharmaceutical industry. The authors distributed a survey to the residency program directors and chief residents of the 16 psychiatry training programs in Canada. Of respondents, 75 per cent were either unaware of or noted an absence of policies or guidelines regarding interactions with the pharmaceutical industry in their training programs; 70 per cent viewed staff psychiatrists and residents to be at least 50 per cent familiar with the Canadian Medical Association's policy summary; and 74 per cent were unaware of any structural teaching regarding potential conflicts of interest between psychiatry and the pharmaceutical industry. A significant number of respondents perceived occasional excessive influence by the pharmaceutical industry on residents' training. Despite concerns about potential conflicts of interest, there are a few guidelines in most psychiatry training programs in Canada regarding the relationship between physicians and the pharmaceutical industry.

  20. Development of an Integrated Performance Measurement (PM) Model for Pharmaceutical Industry

    PubMed Central

    Shabaninejad, Hosein; Mirsalehian, Mohammad Hossein; Mehralian, Gholamhossein

    2014-01-01

    With respect to special characteristics of pharmaceutical industry and lack of reported performance measure, this study tries to design an integrated PM model for pharmaceutical companies. For generating this model; we first identified the key performance indicators (KPIs) and the key result indicators (KRIs) of a typical pharmaceutical company. Then, based on experts᾽ opinions, the identified indicators were ranked with respect to their importance, and the most important of them were selected to be used in the proposed model; In this model, we identified 25 KPIs and 12 KRIs. Although, this model is mostly appropriate to measure the performances of pharmaceutical companies, it can be also used to measure the performances of other industries with some modifications. We strongly recommend pharmaceutical managers to link these indicators with their payment and reward system, which can dramatically affect the performance of employees, and consequently their organization`s success. PMID:24711848

  1. Process simulation in the pharmaceutical industry: a review of some basic physical models.

    PubMed

    Kremer, D M; Hancock, B C

    2006-03-01

    This study reviews process modeling efforts which have been developed to elucidate the fundamental physical process underlying the manufacture and delivery of pharmaceutical dosage forms. Within the pharmaceutical industry, process models have been applied to a diverse array of physical processes at length and time scales that vary by orders of magnitude. As such, both large-scale continuum and particle-scale discrete approaches will be discussed in this study. Challenges associated with the practical application of process models within the pharmaceutical industry will be discussed, and opportunities for future research will be identified.

  2. Postmodern medicine: an analysis of the pharmaceutical industry and its critics.

    PubMed

    Ghaemi, S Nassir

    2013-01-01

    The relationship between physicians and the pharmaceutical industry has been the subject of extensive debate in the last decade or so. This analysis offers some personal observations and suggestions on this discussion from the perspective of psychiatry. The article analyzes a number of critiques of the pharmaceutical industry-the free market myth, the drug price myth, the academic-pharmaceutical complex, lack of innovation, ghost authorship, and the profit motive-in relation to the ethics of medical practice and suggests some public policy solutions. While the focus here is on psychiatry, many of the concepts and principles discussed should apply generally to the medical profession as a whole.

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

    PubMed

    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.

  4. Concentration evolution of pharmaceutically active compounds in raw urban and industrial wastewater.

    PubMed

    Camacho-Muñoz, Dolores; Martín, Julia; Santos, Juan Luis; Aparicio, Irene; Alonso, Esteban

    2014-09-01

    The distribution of pharmaceutically active compounds in the environment has been reported in several works in which wastewater treatment plants have been identified as the main source of these compounds to the environment. The concentrations of these compounds in influent wastewater can vary widely not only during the day but also along the year, because of the seasonal-consumption patterns of some pharmaceuticals. However, only few studies have attempted to assess the hourly variability of the concentrations of pharmaceutically active compounds in wastewater. In this work, the distribution and seasonal and hourly variability of twenty-one pharmaceuticals, belonging to seven therapeutic groups, have been investigated in urban and industrial wastewater. The highest concentrations of pharmaceutically active compounds, except salicylic acid, were found in urban wastewater, especially in the case of anti-inflammatory drugs and caffeine. The highest concentrations of salicylic acid were measured in industrial wastewater, reaching concentration levels up to 3295μgL(-)(1). The studied pharmaceutically active compounds showed different distribution patterns during winter and summer periods. Temporal variability of pharmaceutically active compounds during a 24-h period showed a distribution in concordance with their consumption and excretion patterns, in the case of urban wastewater, and with the schedule of industrial activities, in the case of industrial wastewater.

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

    PubMed

    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.

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

    PubMed

    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.

  7. Legal considerations for social media marketing by pharmaceutical industry.

    PubMed

    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.

  8. Coenzyme Q10 and statin-related myopathy.

    PubMed

    2015-05-01

    Statins inhibit the enzyme 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, which is involved in the production of mevalonic acid in the cholesterol biosynthesis pathway. This pathway also results in the production of other bioactive molecules including coenzyme Q10 (also known as ubiquinone or ubidecarenone). Coenzyme Q10 is a naturally-occurring coenzyme with antioxidant effects that is involved in electron transport in mitochondria and is thought to play a role in energy transfer in skeletal muscle. Muscle-related problems are a frequently reported adverse effect of statins, and it has been hypothesised that a reduced endogenous coenzyme Q10 concentration is a cause of statin-induced myopathy. Coenzyme Q10 supplementation has therefore been proposed to reduce the adverse muscular effects sometimes seen with statins. Here, we consider whether coenzyme Q10 has a place in the management of statin-induced myopathy.

  9. Pathomechanisms in Coenzyme Q10-Deficient Human Fibroblasts

    PubMed Central

    López, Luis C.; Luna-Sánchez, Marta; García-Corzo, Laura; Quinzii, Catarina M.; Hirano, Michio

    2014-01-01

    Primary coenzyme Q10 (CoQ10) deficiency is a rare mitochondrial disorder associated with 5 major clinical phenotypes: (1) encephalomyopathy, (2) severe infantile multisystemic disease, (3) cerebellar ataxia, (4) isolated myopathy, and (5) steroid-resistant nephrotic syndrome. Growth retardation, deafness and hearing loss have also been described in CoQ10-deficient patients. This heterogeneity in the clinical presentations suggests that multiple pathomechanisms may exist. To investigate the biochemical and molecular consequences of CoQ10 deficiency, different laboratories have studied cultures of skin fibroblasts from patients with CoQ10 deficiency. In this review, we summarize the results obtained in these studies over the last decade. PMID:25126049

  10. Inherent Anticipation in the Pharmaceutical and Biotechnology Industries.

    PubMed

    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.

  11. Inherent Anticipation in the Pharmaceutical and Biotechnology Industries

    PubMed Central

    Goldman, Michael; Evans, Georgia; Zappia, Andrew

    2015-01-01

    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. PMID:25877394

  12. Haploinsufficiency of COQ4 causes coenzyme Q10 deficiency

    PubMed Central

    Salviati, Leonardo; Trevisson, Eva; Hernandez, Maria Angeles Rodriguez; Casarin, Alberto; Pertegato, Vanessa; Doimo, Mara; Cassina, Matteo; Agosto, Caterina; Desbats, Maria Andrea; Sartori, Geppo; Sacconi, Sabrina; Memo, Luigi; Zuffardi, Orsetta; Artuch, Rafael; Quinzii, Catarina; DiMauro, Salvatore; Hirano, Michio; Santos-Ocaña, Carlos; Navas, Plácido

    2013-01-01

    Background COQ4 encodes a protein that organises the multienzyme complex for the synthesis of coenzyme Q10 (CoQ10). A 3.9 Mb deletion of chromosome 9q34.13 was identified in a 3-year-old boy with mental retardation, encephalomyopathy and dysmorphic features. Because the deletion encompassed COQ4, the patient was screened for CoQ10 deficiency. Methods A complete molecular and biochemical characterisation of the patient’s fibroblasts and of a yeast model were performed. Results The study found reduced COQ4 expression (48% of controls), CoQ10 content and biosynthetic rate (44% and 43% of controls), and activities of respiratory chain complex II+III. Cells displayed a growth defect that was corrected by the addition of CoQ10 to the culture medium. Knockdown of COQ4 in HeLa cells also resulted in a reduction of CoQ10. Diploid yeast haploinsufficient for COQ4 displayed similar CoQ deficiency. Haploinsufficency of other genes involved in CoQ10 biosynthesis does not cause CoQ deficiency, underscoring the critical role of COQ4. Oral CoQ10 supplementation resulted in a significant improvement of neuromuscular symptoms, which reappeared after supplementation was temporarily discontinued. Conclusion Mutations of COQ4 should be searched for in patients with CoQ10 deficiency and encephalomyopathy; patients with genomic rearrangements involving COQ4 should be screened for CoQ10 deficiency, as they could benefit from supplementation. PMID:22368301

  13. CoQ10 in progressive supranuclear palsy

    PubMed Central

    Scala, Stephanie A.; Hamill, Robert W.; Simon, David K.; Pathak, Subash; Ruthazer, Robin; Standaert, David G.; Yacoubian, Talene A.

    2016-01-01

    Objective: An investigator-initiated, multicenter, randomized, placebo-controlled, double-blind clinical trial to determine whether coenzyme Q10 (CoQ10) is safe, well tolerated, and effective in slowing functional decline in progressive supranuclear palsy (PSP). Methods: Sixty-one participants received CoQ10 (2,400 mg/d) or placebo for up to 12 months. Progressive Supranuclear Palsy Rating Scale (PSPRS), Unified Parkinson's Disease Rating Scale, activities of daily living, Mini-Mental State Examination, the 39-item Parkinson's Disease Questionnaire, and 36-item Short Form Health Survey were monitored at baseline and months 3, 6, 9, and 12. The safety profile of CoQ10 was determined by adverse events, vital signs, and clinical laboratory values. Primary outcome measures were changes in PSPRS and Unified Parkinson's Disease Rating Scale scores from baseline to month 12. Results: CoQ10 was well tolerated. No statistically significant differences were noted between CoQ10 and placebo groups in primary or secondary outcome measures. A nonsignificant difference toward slower clinical decline in the CoQ10 group was observed in total PSPRS among those participants who completed the trial. Before the final study visit at 12 months, 41% of participants withdrew because of travel distance, lack of perceived benefit, comorbidities, or caregiver issues. Conclusions: High doses of CoQ10 did not significantly improve PSP symptoms or disease progression. The high withdrawal rate emphasizes the difficulty of conducting clinical trials in patients with PSP. ClinicalTrials.gov identifier: NCT00382824. Classification of evidence: This study provides Class II evidence that CoQ10 does not significantly slow functional decline in PSP. The study lacks the precision to exclude a moderate benefit of CoQ10. PMID:27583276

  14. [Laqueur and Organon. The university laboratory and the pharmaceutical industry in the Netherlands].

    PubMed

    Oudshoorn, N

    1999-01-01

    Since the 1970s cooperation between universities and pharmaceutical firms is business as usual. This has not always been the case. The first alliances between academic scientists and the pharmaceutical industry can be traced back to the 1920s. Compared to the U.S. and most other European countries, the creation of networks between the Dutch academy and industry shows a rather peculiar pattern that is illustrative in clarifying how the relationships between scientists and the pharmaceutical companies were built. Dutch scientists could not ally themselves with the pharmaceutical industry, simply because no Dutch pharmaceutical company specialized in organpreparations existed prior to the 1920s. This situation forced scientists to opt for the strongest form of alliance they could create, namely to take part in the founding of a pharmaceutical company. Ernst Laqueur, a professor in pharmacology at the University of Amsterdam, was one of the three founders of Organon, the Dutch pharmaceutical firm that was founded in 1923. Based on an analysis of the early history of sex endocrinology, this paper examines the creation of networks between Laqueur and Organon. The paper concludes that the university laboratory played a crucial role in the development of Organon. Organon was dependent on Laqueurs laboratory for the provision of the required biological essay techniques in order to manufacture standardized hormone products, Moreover, Laqueur mediated all the contacts between Organon and the clinic, required for the clinical testing of hormones and the provision of raw materials for the making of hormones into chemicals and drugs.

  15. Partial progress: governing the pharmaceutical industry and the NHS, 1948-2008.

    PubMed

    Abraham, John

    2009-12-01

    Coinciding with sixty years of the U.K. National Health Service (NHS), this article reviews the neglected area of the governance of the pharmaceutical industry and the NHS. It traces the relationships between the pharmaceutical industry, the state, and the NHS from the creation of the health service to the present, as they have grappled with the overlapping challenges of pharmaceutical safety, efficacy, cost-effectiveness, pricing, promotion, and advertising. The article draws on the concepts of "corporate bias" and "regulatory capture" from political theory, and "counter-vailing powers" and "clinical autonomy" in medical sociology, while also introducing the new concepts of "assimilated allies" and "pharmaceuticalization" in order to synthesize a theoretical framework capable of longitudinal empirical analysis of pharmaceutical governance. The analysis identifies areas in which the governance of pharmaceuticals and the NHS has contributed to progress in health care since 1948. However, it is argued that that progress has been slow, restricted, and vulnerable to misdirection due to the enormous and unrivaled influence afforded to the pharmaceutical industry in policy developments. Countervailing influences against such corporate bias have often been limited and subject to destabilization by the industry's assimilated allies either within the state or in the embrace of pharmaceuticalization and consumerism.

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

    NASA Astrophysics Data System (ADS)

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

    2008-12-01

    In order to increase the production efficiency of coenzyme Q10, 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 Q10 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 CoQ10 were investigated in detail. Under optimal conditions, the maximum concentration of the intracellular CoQ10 reached 200.3 mg/L after 80 h fed-batch fermentation, about 245% increasing in CoQ10 production after ion implantation, compared to the original strain.

  17. [Innovative urology needs innovative pharmaceuticals and technology: new cooperation established between BDU and industry].

    PubMed

    Ex, P; Schroeder, A

    2013-08-01

    For some time now medical care has been confronted with great challenges. New developments in the healthcare system result in new possibilities for cooperation in which the Professional Association of German Urologists (BDU) must participate. This is also true with respect to the Pharmaceutical Market Revision Act (AMNOG). The Industry Advisory Board aims to continuously observe and analyze the healthcare political and medical care political developments in Germany and Europe. The Professional Association has created room for a transparent cooperation with the Industry Advisory Board. The AMNOG which came into effect in 2011 also opened integrated contracts for businesses in the pharmaceutical industry.

  18. Kairos as Indeterminate Risk Management: The Pharmaceutical Industry's Response to Bioterrorism

    ERIC Educational Resources Information Center

    Scott, J. Blake

    2006-01-01

    The pharmaceutical industry's response to the threat of bioterrorism following 9-11 invoked the rhetorical notion of kairos as an urgent and ongoing opportunity not only to protect the nation but also to improve the industry's reputation and fortify its political power. Yet the notion of kairos as seizing an advantage--grounded in modernist…

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

    PubMed

    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.

  20. Kairos as Indeterminate Risk Management: The Pharmaceutical Industry's Response to Bioterrorism

    ERIC Educational Resources Information Center

    Scott, J. Blake

    2006-01-01

    The pharmaceutical industry's response to the threat of bioterrorism following 9-11 invoked the rhetorical notion of kairos as an urgent and ongoing opportunity not only to protect the nation but also to improve the industry's reputation and fortify its political power. Yet the notion of kairos as seizing an advantage--grounded in modernist…

  1. [Self-help groups conflicts of interest through sponsoring by the pharmaceutical industry].

    PubMed

    Klemperer, D

    2009-01-01

    Some patient and self-help groups accept financial support from the pharmaceutical industry and medical device manufacturers. For the industry, this constitutes an increasingly important product marketing component. The acceptance of material or other support triggers psychological mechanisms which endanger objective judgement without the persons involved realizing it. Thus, patient groups may evaluate drugs or devices in a positively distorted way.

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

    PubMed

    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.

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

    PubMed

    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.

  4. Coenzyme Q10 contents in foods and fortification strategies.

    PubMed

    Pravst, Igor; Zmitek, Katja; Zmitek, Janko

    2010-04-01

    Coenzyme Q10 (CoQ(10)) is an effective natural antioxidant with a fundamental role in cellular bioenergetics and numerous known health benefits. Reports of its natural occurrence in various food items are comprehensively reviewed and critically evaluated. Meat, fish, nuts, and some oils are the richest nutritional sources of CoQ(10), while much lower levels can be found in most dairy products, vegetables, fruits, and cereals. Large variations of CoQ(10) content in some foods and food products of different geographical origin have been found. The average dietary intake of CoQ(10) is only 3-6 mg, with about half of it being in the reduced form. The intake can be significantly increased by the fortification of food products but, due to its lipophilicity, until recently this goal was not easily achievable particularly with low-fat, water-based products. Forms of CoQ(10) with increased water-solubility or dispersibility have been developed for this purpose, allowing the fortification of aqueous products, and exhibiting improved bioavailability; progress in this area is described briefly. Three main fortification strategies are presented and illustrated with examples, namely the addition of CoQ(10) to food during processing, the addition of this compound to the environment in which primary food products are being formed (i.e. animal feed), or with the genetic modification of plants (i.e. cereal crops).

  5. Coenzyme Q-10 in Human Health: Supporting Evidence?

    PubMed

    Saha, Sibu P; Whayne, Thomas F

    2016-01-01

    Coenzyme Q-10 (CoQ10) is a widely used alternative medication or dietary supplement and one of its roles is as an antioxidant. It naturally functions as a coenzyme and component of oxidative phosphorylation in mitochondria. Decreased levels have been demonstrated in diseased myocardium and in Parkinson disease. Farnesyl pyrophosphate is a critical intermediate for CoQ10 synthesis and blockage of this step may be important in statin myopathy. Deficiency of CoQ10 also has been associated with encephalomyopathy, severe infantile multisystemic disease, cerebellar ataxia, nephrotic syndrome, and isolated myopathy. Although supplementation with CoQ10 has been reported to be beneficial in treating hypertension, congestive heart failure, statin myopathy, and problems associated with chemotherapy for cancer treatement, this use of CoQ10 as a supplement has not been confirmed in randomized controlled clinical trials. Nevertheless, it appears to be a safe supplementary medication where usage in selected clinical situations may not be inappropriate. This review is an attempt to actualize the available information on CoQ10 and define its potential benefit and appropriate usage.

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

    PubMed

    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.

  7. Reduction of ascites mortality in broilers by coenzyme Q10.

    PubMed

    Geng, A L; Guo, Y M; Yang, Y

    2004-09-01

    Effects of coenzyme Q10 (CoQ10) supplementation on growth performance and ascites were studied in broilers. One hundred eighty 1-d-old Arbor Acre male broiler chicks were randomly allocated into 3 groups with 6 replicates each. From d 8, the diets were supplemented with CoQ10 at levels of 0, 20, and 40 mg/kg, respectively. From d 15 to 21, all the chicks were exposed to low ambient temperature (15 to 18 degrees C) to induce ascites. Average feed intake, BW gain, and feed conversion ratio of the broilers during 0 to 3 wk, 3 to 6 wk, and 0 to 6 wk were measured. The results showed that there were no influences observed on broilers' growth performance, but the mortality due to ascites was reduced by CoQ10 supplementation (P < or = 0.05). Erythrocyte osmotic fragility (EOF) was significantly decreased by 40 mg/kg CoQ10 compared with the control, but no significant changes were observed on blood packed cell volume (PCV) among the treatments. Pulmonary arterial diastolic pressure was significantly decreased on d 36, but no significant changes were observed on right ventricular pressure (RVP), pulmonary arterial systolic pressure, and the maximum change ratio of right intraventricular pressure (+/- dp/ dtmax). Ascites heart index (AHI) was significantly decreased by 40 mg/kg CoQ10 supplementation (P < or = 0.05). The results of this study suggested that CoQ10 has a beneficial effect in reducing ascites mortality in broilers, and 40 mg/kg CoQ10 seems to be more effective than 20 mg/ kg CoQ10.

  8. Functions of coenzyme Q10 in inflammation and gene expression.

    PubMed

    Schmelzer, Constance; Lindner, Inka; Rimbach, Gerald; Niklowitz, Petra; Menke, Thomas; Döring, Frank

    2008-01-01

    Clinical studies demonstrated the efficacy of Coenzyme Q10 (CoQ10) as an adjuvant therapeutic in cardiovascular diseases, mitochondrial myopathies and neurodegenerative diseases. More recently, expression profiling revealed that Coenzyme Q10 (CoQ10) influences the expression of several hundred genes. To unravel the functional connections of these genes, we performed a text mining approach using the Genomatix BiblioSphere. We identified signalling pathways of G-protein coupled receptors, JAK/STAT, and Integrin which contain a number of CoQ10 sensitive genes. Further analysis suggested that IL5, thrombin, vitronectin, vitronectin receptor, and C-reactive protein are regulated by CoQ10 via the transcription factor NFkappaB1. To test this hypothesis, we studied the effect of CoQ10 on the NFkappaB1-dependent pro-inflammatory cytokine TNF-alpha. As a model, we utilized the murine macrophage cell lines RAW264.7 transfected with human apolipoprotein E3 (apoE3, control) or pro-inflammatory apoE4. In the presence of 2.5 microM or 75 microM CoQ10 the LPS-induced TNF-alpha response was significantly reduced to 73.3 +/- 2.8% and 74.7 +/- 8.9% in apoE3 or apoE4 cells, respectively. Therefore, the in silico analysis as well as the cell culture experiments suggested that CoQ10 exerts anti-inflammatory properties via NFkappaB1-dependent gene expression.

  9. Pharmacist, the pharmaceutical industry and pharmacy education in Saudi Arabia: A questionnaire-based study.

    PubMed

    Bin Saleh, Ghada; Rezk, Naser L; Laika, Laila; Ali, Anna; El-Metwally, Ashraf

    2015-10-01

    In Saudi Arabia there is an estimated need of more than 100,000 pharmacy graduates to cover all present sectors. The shortage of pharmacists has affected many of these sectors especially the pharmaceutical industry. The contribution of Saudi pharmacists to local pharmaceuticals industry would be extremely beneficial and important for shaping the future of the drug industry within the Kingdom. It is not clear whether future Saudi pharmacists are willing to contribute to local pharmaco-industrial fields. A cross-sectional, questionnaire-based survey was conducted on all final-year pharmacy students in King Saud University (KSU), Riyadh, Kingdom of Saudi Arabia (KSA). Out of a total of 130 students registered in the final-year of the pharmacy program in KSU, 122 (93.8%) were able to complete the questionnaire. The results showed that the majority (83%) of Saudi pharmacy students indicated that they had not received practical training in the pharmaceutical companies, while only 17.2% of the students felt that they had the knowledge and the skills to work in the pharmaceutical industry after graduation. The majority of the students (66.7%) chose clinical pharmacy as their future career field while only 10.9% indicated willingness to work in a pharmaceutical industry career. Only 8.2% selected working in the pharmaceutical industry. The significant predictor of possibly choosing a career in the local drug industry is a student with a bachelor's degree (compared to Pharm D degree) in pharmacy (OR = 2.7 [95% CI 1.1-6.3]). Pharmacy students who are enrolled in the capital city of Riyadh are not properly trained to play an influential role in local drug companies. As a result, their level of willingness to have a career in such important business is not promising (more among Pharm D program). Future research in other pharmacy colleges within Saudi Arabia is needed to confirm such results.

  10. Attitudes and practices of medical graduates in Delhi towards gifts from the pharmaceutical industry.

    PubMed

    Sharma, Vishal; Aggarwal, Sourabh; Singh, Harkirat; Garg, Shashank; Sharma, Alka; Sharma, Rashmi

    2010-01-01

    Pharmaceutical companies use a variety of strategies, including gifts, to influence physicians. In December 2009, the Medical Council of India amended the Code of Medical Ethics to ban medical professionals from accepting gifts from pharmaceutical companies. In view of this ban, it is important to find out the magnitude and contours of the problem amongst Indian medical professionals. We aimed to study, through an e-mail based survey, the attitudes and practices of young resident doctors and interns from two medical colleges of New Delhi regarding acceptance of gifts from the pharmaceutical industry. We e-mailed the questionnaire to 150 fresh graduates. We found that the majority of graduates agreed with existing guidelines: they accepted low cost gifts but considered expensive gifts unrelated to patient welfare unethical. Despite the low response rate, this study is important because data from India on attitudes and practices of medical professionals regarding gifts from the pharmaceutical industry are virtually non-existent.

  11. Limiting the Influence of Pharmaceutical Industry Gifts on Physicians: Self-Regulation or Government Intervention?

    PubMed Central

    2009-01-01

    Concerns over the influence of pharmaceutical gifts on physicians have surged in recent years. This has prompted wide ranging legislative proposals in numerous states and in the federal government as well as stepped up efforts at self-regulation by the pharmaceutical industry and the medical profession. Policymakers face the decision of whether to defer to self-regulation or support government intervention. This commentary describes efforts at self-regulation by the pharmaceutical industry and the medical profession. The author examines and critiques the wide ranging legislative strategies pursued to limit the influence of pharmaceutical gifts on physicians and concludes with suggestions for policymakers and the profession to limit influence and preserve public trust. PMID:19756874

  12. Characterizing dense suspensions: two case studies from the pharmaceutical industry

    NASA Astrophysics Data System (ADS)

    Goldfarb, David J.; Khawaja, Nazia; Kazakevich, Irina; Bhattacharjee, Himanshu; Heslinga, Michael; Dalton, Chad

    2015-11-01

    Liquid suspensions of Active Pharmaceutical Ingredient powders are present as pharmaceutical dosage forms in the form of oral suspensions and injectables. We present two case studies, both dense (~ 30-40%) suspensions, in which the physical characterization of the product, specifically, particle size & shape and rheology were key to understanding the key product attributes as pertaining to the manufacturing process and to patient administration. For the one case study, an oral suspension, identifying variations in particle morphology during the wet milling of the product was key to the product understanding necessary to modify the milling process. Rheological measurements were applied as well. For the second case study, an injectable, results from different particle size measurement techniques and rheological measurements indicated the possibility of flocculation in a formulation. Additionally, measurements were obtained to assess the ``injectability'' of the product via rheometer and texture analyzer measurements and Poiseuille flow modeling. As a result, the relevant shear rate regime for this drug product administration was identified.

  13. Challenges for pharmaceutical industry: new partnerships for sustainable human health.

    PubMed

    Hunter, Jackie

    2011-05-13

    The healthcare burden is increasing in both the developed and the developing world and there is widespread acceptance that the historical pharmaceutical business model is not sustainable. In order to meet the healthcare challenge, companies and academia need to develop new business models to increase the probability of success and decrease the cost of failure. New partnerships have already emerged in the area of neglected diseases and other models for diseases of the developed world are emerging.

  14. Marketing to the consumer: perspectives from the pharmaceutical industry.

    PubMed

    David, C

    2001-01-01

    Individualized health management is one of the most exciting challenges facing health care marketing today. Greater access to health information has empowered consumers to take more control of their health needs, creating a whole new landscape for marketers, manufacturers, and service providers. Customization is the key to creating marketing campaigns that successfully target today's health-conscious consumers. Drawing on individualized market intelligence and available genetic information, pharmaceutical companies are learning to tailor products to meet the needs of this growing market.

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

    PubMed

    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.

  16. Investigating inspection practices of pharmaceutical manufacturing facilities in selected Arab countries: views of inspectors and pharmaceutical industry employees.

    PubMed

    Garg, S; Hasan, R; Scahill, S; Babar, Z Ud-Din

    2013-11-01

    There are few studies that explore inspection practices of pharmaceutical facilities from the viewpoint of inspectors and industry employees. In this descriptive, cross-sectional study, inspectors and quality assurance staff from 4 Arab countries--the United Arab Emirates, Saudi Arabia, Egypt and Jordan--were surveyed about their inspection practices and views. There was considerable variation in inspection practices across countries and between the inspectorate and quality assurance staff within countries. Divergence was found in views associated with payment mechanisms. There was mutual agreement by both groups that inspectors were in short supply and that they needed to be better trained. Inspectors appeared to have less authority than expected in order to control pharmaceutical manufacturing and marketing activities. Compounding this was a dearth of policy which would support a more uniform and systematic approach to the inspection process within and across countries.

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

    PubMed

    Austad, Kirsten E; Avorn, Jerry; Kesselheim, Aaron S

    2011-05-01

    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 about negative

  18. Medical Students' Exposure to and Attitudes about the Pharmaceutical Industry: A Systematic Review

    PubMed Central

    Austad, Kirsten E.; Avorn, Jerry; Kesselheim, Aaron S.

    2011-01-01

    Background 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. Methods and Findings 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. Conclusions Undergraduate medical education provides substantial contact with pharmaceutical marketing, and the extent of such contact is associated with positive

  19. Residency Curricula on Physician-Pharmaceutical Industry Interaction: A CERA Study.

    PubMed

    Evans, David V; Waters, Richard C; Olsen, Cara; Stephens, Mark B; Brown, Steven R

    2016-01-01

    Physician interaction with pharmaceutical representatives results in less evidence-based prescribing and increased costs. Many organizations have called for strong conflict of interest policies in academic institutions. Implementing policy without educational interventions may not adequately address the influence of industry on physician prescribing patterns. The objective of this study is to assess the implementation and content of family medicine residency curricula on the physician-pharmaceutical industry relationship. We surveyed US family medicine program directors using the Council of Academic Family Medicine Educational Research Alliance (CERA) platform. The presence of a formal curriculum on the physician-industry interaction and specific curricular elements (ethics of interaction, understanding detailing sessions and advertisements, use of unbiased pharmaceutical information) were the outcome measures of interest. Fifty-two percent (212 of 406) of program directors responded. Forty percent (95% confidence interval [CI]: 33%--46%) reported having a formal curriculum on physician-pharmaceutical industry interactions. The presence of a formal curriculum was more likely in residencies permitting interaction with industry (52% [48/92] versus 30% [36/120]) or with a university affiliation (43% [75/173] versus 19% [7/36]). The use of unbiased sources of information relating to pharmaceutical products and the ethics of the physician-pharmaceutical industry relationship were the most common curricular elements (59% and 55%, respectively). This study shows that less than half of US family medicine programs have a curriculum addressing physician-industry interactions. Further research on the efficacy of and barriers to curriculum creation and implementation is warranted.

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

    PubMed Central

    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

    Abstract 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 BioFactors, 41(6):383–390, 2015 PMID:26648450

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

    PubMed

    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.

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

    PubMed

    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 < .05). One hundred fourteen (69.1%) preclinical students and 107 (92.2%) clinical students responded. Nearly all students reported at least one exposure to pharmaceutical industry marketing. Seventy-six (71.7%) clinical students compared to 38 (33.3%) preclinical students recalled over 20 exposures (p < .005). Clinical students were more likely to have received a free meal (p < .01), textbook (p < .005), pocket text (p < .005), or trinket (p < .005) than were their preclinical colleagues. Most students (68.2%) had not discussed pharmaceutical marketing with an instructor or advisor; 59 (55.7%) clinical students as compared to 87 (80.6%) preclinical students recalled no such discussion (p < .005). Medical students have extensive exposure to pharmaceutical industry 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.

  3. A systematic review of curricula on relationships between residents and the pharmaceutical industry.

    PubMed

    Montague, Brian T; Fortin, Auguste H; Rosenbaum, Julie

    2008-03-01

    Research has demonstrated the potential adverse impact of pharmaceutical company marketing techniques on doctor knowledge and prescribing practices. Lack of experience may make resident doctors particularly vulnerable to pharmaceutical industry influence. Curricula addressing resident-pharmaceutical industry relations have been reported, but there is no consensus regarding the best approach to take. This study aimed to review published curricula that address resident-pharmaceutical industry relations and to assess them for content, validity and outcomes measures. Curricula were identified via searches of electronic databases and bibliographies of collected articles. Inclusion criteria required articles to describe an educational curriculum, applied in graduate medical education, on relations between doctors and the pharmaceutical industry. The search identified 9 curricula. Most addressed detailing of residents by pharmaceutical representatives. Two articles described curriculum development. Eight articles included an evaluation component; only 1 included a control group for comparison. Modest improvements were noted in resident confidence, knowledge of guidelines, belief in the potential influence of marketing on behaviour, and self-reported acceptance of gifts. Only 2 evaluations used a validated outcome instrument, and no studies included longterm follow-up. A limited number of curricula have addressed resident-pharmaceutical industry interactions. Inconsistency in content, application and evaluation methodology prevents any meaningful synthesis of data. Resident attitudes and behaviours may be affected, but the outcome measures used lacked sufficient validity to assess improvements in knowledge and analytic skills. A clearer delineation of the curriculum development process and the use of standardised outcome measures would facilitate the reproduction of positive results at other institutions.

  4. Cardiofaciocutaneous (CFC) syndrome associated with muscular coenzyme Q10 deficiency.

    PubMed

    Aeby, A; Sznajer, Y; Cavé, H; Rebuffat, E; Van Coster, R; Rigal, O; Van Bogaert, P

    2007-10-01

    The cardiofaciocutaneous (CFC) syndrome is characterized by congenital heart defect, developmental delay, peculiar facial appearance with bitemporal constriction, prominent forehead, downslanting palpebral fissures, curly sparse hair and abnormalities of the skin. CFC syndrome phenotypically overlaps with Noonan and Costello syndromes. Mutations of several genes (PTPN11, HRAS, KRAS, BRAF, MEK1 and MEK2), involved in the mitogen-activated protein kinase (MAPK) pathway, have been identified in CFC-Costello-Noonan patients. Coenzyme Q10 (CoQ10), a lipophilic molecule present in all cell membranes, functions as an electron carrier in the mitochondrial respiratory chain, where it transports electrons from complexes I and II to complex III. CoQ10 deficiency is a rare treatable mitochondrial disorder with various neurological (cerebellar ataxia, myopathy, epilepsy, mental retardation) and extraneurological (cardiomyopathy, nephropathy) signs that are responsive to CoQ10 supplementation. We report the case of a 4-year-old girl who presented a CFC syndrome, confirmed by the presence of a pathogenic R257Q BRAF gene mutation, together with a muscular CoQ10 deficiency. Her psychomotor development was severely impaired, hindered by muscular hypotonia and ataxia, both improving remarkably after CoQ10 treatment. This case suggests that there is a functional connection between the MAPK pathway and the mitochondria. This could be through the phosphorylation of a nuclear receptor essential for CoQ10 biosynthesis. Another hypothesis is that K-Ras, one of the proteins composing the MAPK pathway, might be recruited into the mitochondria to promote apoptosis. This case highlights that CoQ10 might contribute to the pathogenesis of CFC syndrome.

  5. Hormonal Influence on Coenzyme Q10 Levels in Blood Plasma

    PubMed Central

    Mancini, Antonio; Festa, Roberto; Raimondo, Sebastiano; Pontecorvi, Alfredo; Littarru, Gian Paolo

    2011-01-01

    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. PMID:22272129

  6. Antibiotics: the changing regulatory and pharmaceutical industry paradigm.

    PubMed

    Bax, Richard; Green, Samantha

    2015-05-01

    Drug licensing is changing. Previously, regulators prioritized the licensing of innovative drugs that fulfilled a high unmet medical need for a small number of patients, including orphan, cancer and HIV medicines. Alternatives to large and costly prospective, randomized, double-blind clinical trials have led to a more bespoke development, such as adaptive design studies. Regulators have recently agreed to include much-needed narrow-spectrum antibiotics, active against certain MDR bacteria, in this paradigm. The background to why big pharmaceutical companies have largely deserted the antibacterial research arena, and the proposals that are hoped to reinvigorate their interest, are presented.

  7. Bioinformatics, target discovery and the pharmaceutical/biotechnology industry.

    PubMed

    Fagan, R; Swindells, M

    2000-12-01

    With the first draft of the human genome now available a directed genome-wide mining strategy is being implemented by many pharmaceutical and biotechnology companies in order to identify novel members of the most therapeutically relevant target families. At the same time there is an increasing amount of annotation relevant to the human genome sequence entering into the public domain. The ability to identify protein families on a genome-wide scale can only be done at speed by using high-throughput computational approaches. This review describes many of the latest algorithmic developments in this field and shows how they can be best put to use for target identification and prioritization.

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

    PubMed

    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.

  9. [PHARMACEUTICAL INDUSTRY AND PERSONALIZED MEDICINE: A PARADIGM SHIFT IN THE DEVELOPMENT OF NEW DRUGS].

    PubMed

    Scheen, A J

    2015-01-01

    The cost of pharmacotherapy is increasing in the health care budget. The pharmaceutical industry is facing the exhaustion of medications that are largely prescribed and have a high profitability (blockbusters). Because of patient heterogeneity, there is a great interindividual variability of the responses to drug therapy. Thus, it is essential to better detect potential to avoid waste of resources resulting from the prescription of expensive drugs to poor responders. The development of personalized medicine, or precision medicine, certainly offers opportunities to the pharmaceutical industry, but also exposes it to new big challenges.

  10. Health Canada and the pharmaceutical industry: a preliminary analysis of the historical relationship.

    PubMed

    Lexchin, Joel

    2013-11-01

    In the past two decades, Health Canada has been accused of favouring the pharmaceutical industry over the public in areas of pharmaceutical policy. This orientation has been tied to the introduction of user fees by the industry in 1994 that help finance key aspects of drug regulation. This paper provides a preliminary examination of the history of the relationship starting in 1939 until the mid-1980s in an attempt to discern whether 1994 really represented a key turning point. Clientele pluralism, a theory that explains the relationship between the state and interest groups, is used to explain the nature of the events described. Copyright © 2013 Longwoods Publishing.

  11. [The Brazilian pharmaceutical industry and foreign trade: is there evidence of regressive specialization?].

    PubMed

    Mota, Fábio Batista; Cassiolato, José Eduardo; Gadelha, Carlos Augusto Grabois

    2012-03-01

    Based on an exploratory discussion, the aim of this article is to investigate whether there is evidence of regressive specialization in the foreign trade pattern of the Brazilian pharmaceutical industry since trade liberalization in the 1990s. A descriptive statistical analysis drew on data for foreign trade in pharmaceutical and organic chemical products, available in the Aliceweb system of the Ministry of Development, Industry, and Foreign Trade, covering the periods 1989-1995 and 1996-2008. The results, especially concerning trends in Brazil's trade with developed countries, suggest evidence of regressive specialization.

  12. Health Canada and the Pharmaceutical Industry: A Preliminary Analysis of the Historical Relationship

    PubMed Central

    Lexchin, Joel

    2013-01-01

    In the past two decades, Health Canada has been accused of favouring the pharmaceutical industry over the public in areas of pharmaceutical policy. This orientation has been tied to the introduction of user fees by the industry in 1994 that help finance key aspects of drug regulation. This paper provides a preliminary examination of the history of the relationship starting in 1939 until the mid-1980s in an attempt to discern whether 1994 really represented a key turning point. Clientele pluralism, a theory that explains the relationship between the state and interest groups, is used to explain the nature of the events described. PMID:24359714

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

    PubMed

    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. Pharmaceutical industry interactions in family medicine residencies decreased between 2008 and 2013: a CERA study.

    PubMed

    Brown, Steven R; Evans, David V; Fugh-Berman, Adriane

    2015-04-01

    Most medical residents have some interaction with the pharmaceutical industry. It is not known if this interaction has changed over time. We determined whether interactions between family medicine residencies and the pharmaceutical industry have changed in the past 5 years. We surveyed program directors of US family medicine residencies with questions addressing industry-sponsored gifts, drug samples, access of industry representatives to trainees, and industry-sponsored residency activities. The questions were part of a larger 2013 survey administered by the Council of Academic Family Medicine Educational Research Alliance (CERA). The authors compared results from 2008 and 2013. The response rate to the 2013 CERA program director survey was 56% (251/445); 47% (208/445) of surveyed directors viewed and answered all survey questions. Between 2008 and 2013, residency programs that accept no gifts or industry-sponsored food increased from 48% (137/286) to 73% (151/208). Residencies refusing samples increased from 52% (148/286) to 78% (166/212), and residencies that do not allow industry representatives to have access to learners increased from 43% (124/286) to 74% (157/212). Residency programs that forbade industry-sponsored activities remained stable (67% versus 73%). About half (49%) (101/208)) of programs in 2013 qualified as "pharma-free," compared to 26% (75/286) in 2008. In 2013, one of two family medicine residencies disallow gifts, drug samples, interactions between residents and pharmaceutical sales representatives, and pharmaceutical industry-sponsored activities. This proportion is twice what was observed in 2008. Restrictions increased in all categories except industry-sponsored activities.

  15. Financial ties between DSM-IV panel members and the pharmaceutical industry.

    PubMed

    Cosgrove, Lisa; Krimsky, Sheldon; Vijayaraghavan, Manisha; Schneider, Lisa

    2006-01-01

    Increasing attention has been given to the transparency of potential conflicts of interest in clinical medicine and biomedical sciences, particularly in journal publishing and science advisory panels. The authors examined the degree and type of financial ties to the pharmaceutical industry of panel members responsible for revisions of the Diagnostic and Statistical Manual of Mental Disorders(DSM). By using multimodal screening techniques the authors investigated the financial ties to the pharmaceutical industry of 170 panel members who contributed to the diagnostic criteria produced for the DSM-IV and the DSM-IV-TR. Of the 170 DSM panel members 95 (56%) had one or more financial associations with companies in the pharmaceutical industry. One hundred percent of the members of the panels on 'Mood Disorders' and 'Schizophrenia and Other Psychotic Disorders' had financial ties to drug companies. The leading categories of financial interest held by panel members were research funding (42%), consultancies (22%) and speakers bureau (16%). Our inquiry into the relationships between DSM panel members and the pharmaceutical industry demonstrates that there are strong financial ties between the industry and those who are responsible for developing and modifying the diagnostic criteria for mental illness. The connections are especially strong in those diagnostic areas where drugs are the first line of treatment for mental disorders. Full disclosure by DSM panel members of their financial relationships with for-profit entities that manufacture drugs used in the treatment of mental illness is recommended.

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

    PubMed

    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. Guidelines for interactions between clinical faculty and the pharmaceutical industry: one medical school's approach.

    PubMed

    Coleman, David L; Kazdin, Alan E; Miller, Lee Ann; Morrow, Jon S; Udelsman, Robert

    2006-02-01

    A productive and ethical relationship between the pharmaceutical industry and physicians is critical to improving drug discovery and public health. In response to concerns about inappropriate financial relationships between the pharmaceutical industry and physicians, national organizations representing physicians or industry have made recommendations designed to reduce conflicts of interest, legal exposure, and dissemination of biased information. Despite these initiatives, the prescribing practices of physicians may be unduly influenced by the marketing efforts of industry and physicians may inadvertently distribute information that is biased in favor of a commercial entity. Moreover, physicians may be vulnerable to prosecution through federal anti-kickback and false claims statutes because of potentially inappropriate financial relationships with pharmaceutical companies. Since academic medical centers have a critical role in establishing professional standards, the faculty of Yale University School of Medicine developed guidelines for the relationships of faculty with the pharmaceutical industry, which were approved in May 2005. Input from clinical faculty and from representatives of the pharmaceutical industry was utilized in formulating the guidelines. In contrast to existing recommendations, the Yale guidelines, which are presented as an Appendix here, ban faculty from receiving any form of gift, meal, or free drug sample (for personal use) from industry, and set more stringent standards for the disclosure and resolution of financial conflict of interest in Yale's educational programs. The growing opportunities for drug discovery, the need to use medications in a more evidence-based manner, and preservation of the public trust require the highest professional standards of rigor and integrity. These guidelines are offered as part of the strategy to meet this compelling challenge.

  18. Coenzyme Q(10) in male infertility: physiopathology and therapy.

    PubMed

    Mancini, Antonio; Balercia, Giancarlo

    2011-01-01

    Both the bioenergetic and the antioxidant role of CoQ(10) suggest a possible involvement in sperm biochemistry and male infertility. CoQ(10) can be quantified in seminal fluid, where its concentration correlates with sperm count and motility. It was found that distribution of CoQ(10) between sperm cells and seminal plasma was altered in varicocele patients, who also presented a higher level of oxidative stress and lower total antioxidant capacity. The effect of vericocelectomy on partially reversing these biochemical abnormalities is discussed. The redox status of coenzyme Q(10) in seminal fluid was also determined: an inverse correlation was found between ubiquinol/ubiquinone ratio and hydroperoxide levels and between this ratio and the percentage of abnormal sperm forms. After the first in vitro observations CoQ(10) was administered to infertile patients affected by idiopathic asthenozoospermia, originally in an open label study and then in three randomized placebo-controlled trials; doses were around 200-300 mg/day and treatment lasted 6 months. A significant increase in the concentration of CoQ(10) was found, both in seminal plasma and sperm cells. Treatment also led to a certain improvement in sperm motility. In one of the studies there was also a decrease in plasma levels of follicle stimulating horhone (FSH) and luteinizine horhone (LH). Administration of CoQ(10) may play a positive role in the treatment of asthenozoospermia, possibly related to not only to its function in the mitochondrial respiratory chain but also to its antioxidant properties. Further studies are needed in order to determine whether there is also an effect on fertility rate. Copyright © 2011 International Union of Biochemistry and Molecular Biology, Inc.

  19. [Chapter 5. The internationalization of the Japanese pharmaceutical industry (1980-2010)].

    PubMed

    Yongue, Julia S

    2014-01-01

    The Japanese pharmaceutical industry experienced a period of rapid and economic growth following the introduction of the national healthcare system in 1961. Triggered by a major revision in Japanese legislation from process to substance patents, leading Japanese pharmaceutical companies began to invest in research and development (R&D). By the mid-1980s, some had managed to develop their first internationally marketable drugs, many of which were antibiotics. The emergence of novel drugs gave companies the impetus to engage in progressively more appreciable investments in Asia, Europe and the United States. In the 1980s, internationalization was mainly inwardly focused so as to limit firms' exposure to risk. However, as profits increased in the 1990s from the sale of new drugs, Japanese pharmaceutical companies were able to engage in even more sizeable, outwardly focused investments. By 2010, Japan's leading pharmaceutical enterprises had succeeded in putting place three types of global operations: manufacturing, marketing and R&D.

  20. Modelling and simulation in the pharmaceutical industry--some reflections.

    PubMed

    Burman, Carl-Fredrik; Wiklund, Stig Johan

    2011-01-01

    Modelling and simulation (M&S) is increasingly being applied in (clinical) drug development. It provides an opportune area for the community of pharmaceutical statisticians to pursue. In this article, we highlight useful principles behind the application of M&S. We claim that M&S should be focussed on decisions, tailored to its purpose and based in applied sciences, not relying entirely on data-driven statistical analysis. Further, M&S should be a continuous process making use of diverse information sources and applying Bayesian and frequentist methodology, as appropriate. In addition to forming a basis for analysing decision options, M&S provides a framework that can facilitate communication between stakeholders. Besides the discussion on modelling philosophy, we also describe how standard simulation practice can be ineffective and how simulation efficiency can often be greatly improved.

  1. Anti-counterfeit technologies: a pharmaceutical industry perspective.

    PubMed

    Bansal, Dipika; Malla, Swathi; Gudala, Kapil; Tiwari, Pramil

    2013-01-01

    Growth of international free trade and inadequate drug regulation have led to the expansion of trade in counterfeit drugs worldwide. Technological protection is seen to be the best way to avoid this problem. Different technologies came into existence like overt, covert, and track and trace technologies. This review emphasises ideal technological characteristics, existing anti-counterfeit technologies, and their adoption in different countries. Developed countries like the USA have implemented RFID while the European trend is towards 2D barcodes. The Indian government is getting sensitised about the extent of the problem and has formulated rules mandating barcodes. Even the pharmaceutical companies have been employing these technologies in order to detain illegitimate drugs in their supply chain.

  2. Applications of terahertz-pulsed technology in the pharmaceutical industry

    NASA Astrophysics Data System (ADS)

    Taday, Philip F.

    2010-02-01

    Coatings are applied to pharmaceutical tablets (or pills) to for either cosmetic or release control reasons. Cosmetic coatings control the colour or to mask the taste of an active ingredient; the thickness of these coating is not critical to the performance of the product. On the other hand the thickness and uniformity of a controlled release coating has been found affect the release of the active ingredient. In this work we have obtained from a pharmacy single brand of pantoprazole tablet and mapped them using terahertz pulsed imaging (TPI) prior to additional dissolution testing. Three terahertz parameters were derived for univariate analysis for each layer: coating thickness, terahertz electric field peak strength and terahertz interface index. These parameters were then correlated dissolution tested. The best fit was found to be with combined coating layer thickness of the inert layer and enteric coating. The commercial tablets showed a large variation in coating thickness.

  3. Anti-Counterfeit Technologies: A Pharmaceutical Industry Perspective

    PubMed Central

    Bansal, Dipika; Malla, Swathi; Gudala, Kapil; Tiwari, Pramil

    2013-01-01

    Growth of international free trade and inadequate drug regulation have led to the expansion of trade in counterfeit drugs worldwide. Technological protection is seen to be the best way to avoid this problem. Different technologies came into existence like overt, covert, and track and trace technologies. This review emphasises ideal technological characteristics, existing anti-counterfeit technologies, and their adoption in different countries. Developed countries like the USA have implemented RFID while the European trend is towards 2D barcodes. The Indian government is getting sensitised about the extent of the problem and has formulated rules mandating barcodes. Even the pharmaceutical companies have been employing these technologies in order to detain illegitimate drugs in their supply chain. PMID:23641326

  4. Medical specialists and pharmaceutical industry-sponsored research: a survey of the Australian experience.

    PubMed

    Henry, David A; Kerridge, Ian H; Hill, Suzanne R; McNeill, Paul M; Doran, Evan; Newby, David A; Henderson, Kim M; Maguire, Jane; Stokes, Barrie J; Macdonald, Graham J; Day, Richard O

    2005-06-06

    To characterise research relationships between medical specialists and the pharmaceutical industry in Australia. Questionnaire survey of medical specialists listed in the Medical Directory of Australia and believed to be in active practice, conducted in 2002 and 2003. Details of medical specialists' involvement in pharmaceutical industry-sponsored research, and reports of potentially undesirable research outcomes. Of 2120 specialists approached, 823 (39%) responded. Participation in pharmaceutical industry-sponsored research was more commonly reported by those in salaried practice (49%) than those in private practice (33%); P < 0.001. 216 reported that industry had made initial contact, compared with 117 who had initiated contact with industry. 14.0% of respondents reported premature termination of industry-sponsored trials, which they considered appropriate when in response to concerns about adverse drug effects. 12.3% of respondents reported that industry staff had written first drafts of reports, which they viewed as an acceptable practice for "internal" documents only. Of greatest concern to respondents were instances of delayed publication or non-publication of key negative findings (reported by 6.7% and 5.1% of respondents, respectively), and concealment of results (2.2%). Overall, 71 respondents (8.6%) had experienced at least one event that could represent breaches of research integrity. These data indicate a high level of engagement in research between the pharmaceutical industry and medical specialists, including those in private practice. Examples of possibly serious research misconduct were reported by 8.6% of respondents, equivalent to 21% of those with an active research relationship with industry.

  5. Process analytical technology in the pharmaceutical industry: a toolkit for continuous improvement.

    PubMed

    Scott, Bradley; Wilcock, Anne

    2006-01-01

    Process analytical technology (PAT) refers to a series of tools used to ensure that quality is built into products while at the same time improving the understanding of processes, increasing efficiency, and decreasing costs. It has not been widely adopted by the pharmaceutical industry. As the setting for this paper, the current pharmaceutical manufacturing paradigm and PAT guidance to date are discussed prior to the review of PAT principles and tools, benefits, and challenges. The PAT toolkit contains process analyzers, multivariate analysis tools, process control tools, and continuous improvement/knowledge management/information technology systems. The integration and implementation of these tools is complex, and has resulted in uncertainty with respect to both regulation and validation. The paucity of staff knowledgeable in this area may complicate adoption. Studies to quantitate the benefits resulting from the adoption of PAT within the pharmaceutical industry would be a valuable addition to the qualitative studies that are currently available.

  6. A randomized trial of coenzyme Q10 in mitochondrial disorders.

    PubMed

    Glover, Elisa I; Martin, Joan; Maher, Amy; Thornhill, Rebecca E; Moran, Gerald R; Tarnopolsky, Mark A

    2010-11-01

    Case reports and open-label studies suggest that coenzyme Q(10) (CoQ(10)) treatment may have beneficial effects in mitochondrial disease patients; however, controlled trials are warranted to clinically prove its effectiveness. Thirty patients with mitochondrial cytopathy received 1200 mg/day CoQ(10) for 60 days in a randomized, double-blind, cross-over trial. Blood lactate, urinary markers of oxidative stress, body composition, activities of daily living, quality of life, forearm handgrip strength and oxygen desaturation, cycle exercise cardiorespiratory variables, and brain metabolites were measured. CoQ(10) treatment attenuated the rise in lactate after cycle ergometry, increased (∽1.93 ml) VO(2)/kg lean mass after 5 minutes of cycling (P < 0.005), and decreased gray matter choline-containing compounds (P < 0.05). Sixty days of moderate- to high-dose CoQ(10) treatment had minor effects on cycle exercise aerobic capacity and post-exercise lactate but did not affect other clinically relevant variables such as strength or resting lactate.

  7. Risk Communication and the Pharmaceutical Industry: what is the reality?

    PubMed

    Edwards, Brian; Chakraborty, Sweta

    2012-11-01

    Risk communication is central to the risk management strategy of a pharmaceutical company. Pharmaceutical companies primarily communicate risk through labelling tools such as the Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL) and the carton, which are currently regulated based on templates such as those of the EU. Recent research raises concern about how effective the SmPC is alone in communicating risk. There is some evidence that carton design can influence risk comprehension. Processes to check new trade names cannot be confused with existing names is a simple measure to mitigate one form of risk. Given the central role and the vast amount of resource that is consumed, it is surprising there has not been extensive original research to see whether product information such as the SmPC is a good tool for communicating risk. Recently, EU agencies have assessed the communication value of the PIL and revised the template and guidelines. However, no evaluation of user testing has been conducted at European level since the introduction of these new requirements. As regards 'Dear Healthcare Professional Communications', there is inconsistent evidence about their ability to change patient and physician behaviour. There is a dearth of evidence about what sort of communications materials are the most effective under which circumstances. The use of templates restricts the flexibility of companies to adapt their risk messages to their targets. Effective communication requires understanding how different audiences perceive the message and what the fundamental drivers are for altering patient and prescriber behaviour to be safer. This requires careful consideration of the relationship between risk communication, perception and management. However, the focus of a company's risk communication plan is normally on the International Conference on Harmonisation (ICH) regions and their regulations. Although the same regulatory tools are

  8. How to improve R&D productivity: the pharmaceutical industry's grand challenge.

    PubMed

    Paul, Steven M; Mytelka, Daniel S; Dunwiddie, Christopher T; Persinger, Charles C; Munos, Bernard H; Lindborg, Stacy R; Schacht, Aaron L

    2010-03-01

    The pharmaceutical industry is under growing pressure from a range of environmental issues, including major losses of revenue owing to patent expirations, increasingly cost-constrained healthcare systems and more demanding regulatory requirements. In our view, the key to tackling the challenges such issues pose to both the future viability of the pharmaceutical industry and advances in healthcare is to substantially increase the number and quality of innovative, cost-effective new medicines, without incurring unsustainable R&D costs. However, it is widely acknowledged that trends in industry R&D productivity have been moving in the opposite direction for a number of years. Here, we present a detailed analysis based on comprehensive, recent, industry-wide data to identify the relative contributions of each of the steps in the drug discovery and development process to overall R&D productivity. We then propose specific strategies that could have the most substantial impact in improving R&D productivity.

  9. [Are medical students influenced by the promotion of the pharmaceutical industry?].

    PubMed

    Giustetto, Guido

    2014-12-01

    The pharmaceutical and medical devices industry provides one of the main sources of scientific information for physicians. The impact of this kind of information on physicians' prescribing behavior has been extensively studied. Available evidence consistently shows that prescription habits are affected by industry-driven scientific research data. This questionable influence has an impact also on medical students, residents, and doctors in training. Recent studies have shown that a frequent contact with industry representatives is inversely related to the knowledge of the foundations of evidence-based medicine and directly related to a higher use of brand-name prescription drugs. Several American universities decided to prohibit any relationships between students and industry representatives. It would be desirable that such policies be adopted by other institutions. In addition, the practical guide published by the World Health Organization "Understanding and Responding to Pharmaceutical Promotion" should be better known and used.

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

    PubMed

    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. Current trends in the pharmaceutical industry--a case study approach.

    PubMed

    Rusu, Alexandru; Kuokkanen, Katja; Heier, Annabelle

    2011-10-09

    This commentary offers an overview of some current trends of the pharmaceutical industry drawing on examples taken from the analysis of four companies (Pfizer, Merck, Novo Nordisk, Crucell). The very brief analysis looks at diversification paths, pipeline management strategies, generic competition as well as corporate social responsibility policies.

  12. Pharmaceutical Industry Viewpoint of Wordage Problems--Amount, Languages, and Access

    ERIC Educational Resources Information Center

    Starker, L. N.

    1972-01-01

    In the pharmaceutical industry more emphasis will be required on tertiary sources which maintain multiple computer-based files. These files are now being made available for SDI purposes, while their usefulness for retrospective searches still needs to be evaluated. (7 references) (Author/NH)

  13. Attitudes of Medical School Faculty toward Gifts from the Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Banks, James W., III; Mainous, Arch G., III

    1992-01-01

    A survey of 248 University of Kentucky medical school faculty investigated attitudes toward American Medical Association policy concerning gifts from the pharmaceutical industry. Faculty generally agreed with the guidelines but felt gifts did not influence prescribing behaviors. PhD faculty favored more prescriptive policy than did MD faculty.…

  14. A Survey of the Interactions between Psychiatry Residency Programs and the Pharmaceutical Industry

    ERIC Educational Resources Information Center

    Varley, Christopher K.; Jibson, Michael D.; McCarthy, Mary; Benjamin, Sheldon

    2005-01-01

    OBJECTIVE: The authors report a survey of the American Association of Directors of Psychiatry Residency Training (AADPRT) on interactions between the pharmaceutical industry and psychiatry residency programs. METHODS: American Association of Directors of Psychiatry Residency Training membership was anonymously surveyed by e-mail and by paper…

  15. The Role of the Pharmaceutical Industry in Teaching Psychopharmacology: A Growing Problem

    ERIC Educational Resources Information Center

    Brodkey, Amy C.

    2005-01-01

    OBJECTIVE: To describe and examine the role of the pharmaceutical industry in the teaching of psychopharmacology to residents and medical students and to make recommendations for changes in curriculum and policy based on these findings. METHODS: Literature reviews and discussions with experts, educators, and trainees. RESULTS: The pharmaceutical…

  16. Skills for a Competitive Future: A Survey for the Pharmaceutical Industry National Training Organisation. IES Report.

    ERIC Educational Resources Information Center

    Jagger, Nick; Aston, Jane

    This report focuses on a study that examined skills, recruitment, and training issues covering the whole pharmaceutical industry. It presents mailed survey material complemented and enhanced by a series of telephone interviews and focus groups. Chapter 1 is an introduction. Chapter 2 deals with the structure of the sector and reports background…

  17. Towards novel processes for the fine-chemical and pharmaceutical industries.

    PubMed

    Huisman, Gjalt W; Gray, David

    2002-08-01

    In response to the need in the pharmaceutical industry for more complex, chiral molecules, fine-chemical companies are embracing new manufacturing technologies to produce compounds of these specifications. In particular, recent developments in biocatalysis combined with novel process engineering are providing improved methods for the production of valuable chemical intermediates.

  18. [The rational basis for the short-, medium-, and long-term evolution of the pharmaceutical industry].

    PubMed

    Amédée-Manesme, O

    In the last few years, a worldwide reorganization affecting the entire pharmaceutical industry has begun and is now accelerating. This intense trend of mergers, acquisitions, market entires++ and exits, reorientation and diversification reflects a new environment. This article sets out to explain the reasons behind this inescapable and rapid evolution.

  19. The Role of the Pharmaceutical Industry in Teaching Psychopharmacology: A Growing Problem

    ERIC Educational Resources Information Center

    Brodkey, Amy C.

    2005-01-01

    OBJECTIVE: To describe and examine the role of the pharmaceutical industry in the teaching of psychopharmacology to residents and medical students and to make recommendations for changes in curriculum and policy based on these findings. METHODS: Literature reviews and discussions with experts, educators, and trainees. RESULTS: The pharmaceutical…

  20. A review on characterization and bioremediation of pharmaceutical industries' wastewater: an Indian perspective

    NASA Astrophysics Data System (ADS)

    Rana, Rajender Singh; Singh, Prashant; Kandari, Vikash; Singh, Rakesh; Dobhal, Rajendra; Gupta, Sanjay

    2014-08-01

    During the past few decades, pharmaceutical industries have registered a quantum jump contributing to high economic growth, but simultaneously it has also given rise to severe environmental pollution. Untreated or allegedly treated pharmaceutical industrial wastewater (PIWW) creates a need for time to time assessment and characterization of discharged wastewater as per the standards provided by the regulatory authorities. To control environmental pollution, pharmaceutical industries use different treatment plans to treat and reuse wastewater. The characterization of PIWW using advanced and coupled techniques has progressed to a much advanced level, but in view of new developments in drug manufacture for emerging diseases and the complexities associated with them, better sophisticated instrumentation and methods of treatment are warranted. The bioremediation process to treat PIWW has undergone more intense investigation in recent decade. This results in the complete mineralization of pharmaceutical industries' wastewater and no waste product is obtained. Moreover, high efficiency and low operation cost prove it to be an effective tool for the treatment of PIWW. The present review focuses on the characterization as well as bioremediation aspects of PIWW.

  1. An assessment of R&D productivity in the pharmaceutical industry.

    PubMed

    Dimitri, Nicola

    2011-12-01

    Recent reports suggest that R&D productivity in the pharmaceutical industry can be strengthened by reducing costs both in the early phase and, mostly, in the clinical phase of drug discovery. However, a cost-benefit probabilistic analysis reveals that despite high costs, the clinical phase shows healthy productivity, whereas the early phase, particularly lead optimization, exhibits very low productivity.

  2. A Survey of the Interactions between Psychiatry Residency Programs and the Pharmaceutical Industry

    ERIC Educational Resources Information Center

    Varley, Christopher K.; Jibson, Michael D.; McCarthy, Mary; Benjamin, Sheldon

    2005-01-01

    OBJECTIVE: The authors report a survey of the American Association of Directors of Psychiatry Residency Training (AADPRT) on interactions between the pharmaceutical industry and psychiatry residency programs. METHODS: American Association of Directors of Psychiatry Residency Training membership was anonymously surveyed by e-mail and by paper…

  3. A review on characterization and bioremediation of pharmaceutical industries' wastewater: an Indian perspective

    NASA Astrophysics Data System (ADS)

    Rana, Rajender Singh; Singh, Prashant; Kandari, Vikash; Singh, Rakesh; Dobhal, Rajendra; Gupta, Sanjay

    2017-03-01

    During the past few decades, pharmaceutical industries have registered a quantum jump contributing to high economic growth, but simultaneously it has also given rise to severe environmental pollution. Untreated or allegedly treated pharmaceutical industrial wastewater (PIWW) creates a need for time to time assessment and characterization of discharged wastewater as per the standards provided by the regulatory authorities. To control environmental pollution, pharmaceutical industries use different treatment plans to treat and reuse wastewater. The characterization of PIWW using advanced and coupled techniques has progressed to a much advanced level, but in view of new developments in drug manufacture for emerging diseases and the complexities associated with them, better sophisticated instrumentation and methods of treatment are warranted. The bioremediation process to treat PIWW has undergone more intense investigation in recent decade. This results in the complete mineralization of pharmaceutical industries' wastewater and no waste product is obtained. Moreover, high efficiency and low operation cost prove it to be an effective tool for the treatment of PIWW. The present review focuses on the characterization as well as bioremediation aspects of PIWW.

  4. Pharmaceutical Industry Viewpoint of Wordage Problems--Amount, Languages, and Access

    ERIC Educational Resources Information Center

    Starker, L. N.

    1972-01-01

    In the pharmaceutical industry more emphasis will be required on tertiary sources which maintain multiple computer-based files. These files are now being made available for SDI purposes, while their usefulness for retrospective searches still needs to be evaluated. (7 references) (Author/NH)

  5. Medical Education and the Pharmaceutical Industry: A Review of Ethical Guidelines and Their Implications for Psychiatric Training

    ERIC Educational Resources Information Center

    Geppert, Cynthia M. A.

    2007-01-01

    Objective: This article reviews and summarizes eight ethical guidelines of major professional organizations regarding the pharmaceutical industry's role in the psychiatric education of trainees. Method: The author conducted a literature review of research and guidelines pertaining to the pharmaceutical industry's relationship to trainees, with…

  6. Medical Education and the Pharmaceutical Industry: A Review of Ethical Guidelines and Their Implications for Psychiatric Training

    ERIC Educational Resources Information Center

    Geppert, Cynthia M. A.

    2007-01-01

    Objective: This article reviews and summarizes eight ethical guidelines of major professional organizations regarding the pharmaceutical industry's role in the psychiatric education of trainees. Method: The author conducted a literature review of research and guidelines pertaining to the pharmaceutical industry's relationship to trainees, with…

  7. [Patents in pharmaceutical industry: between ethics and property rights].

    PubMed

    Martínez Cárdenas, Edgar E

    2003-01-01

    The article presents a reflection on one of the greater challenges which the contemporary State is confronted with, related to guaranteeing the effective application of the fundamental rights, besides having to solve the conflicts that arise due to the rivalry between either fundamental rights or between some of these and others known as second or third generation rights. The conflict between the protection to the intellectual property rights, as in the case of the patents of the pharmaceutical multinationals, and the fundamental right to life is considered. It is observed that the interests of these companies have prevailed, as if the fundamental value to protect was the profit of these multinationals, or their efficiency, and not the right to health of the individuals which bears a direct relation with the right to the life. This situation is aggravated still more when the State, instead of being on the side of the weaker and offering him protection, safeguards the stronger who abuse of their dominant position, exerting the monopoly on the production of many essential medicines.

  8. Bioenergetic and antioxidant properties of coenzyme Q10: recent developments.

    PubMed

    Littarru, Gian Paolo; Tiano, Luca

    2007-09-01

    For a number of years, coenzyme Q (CoQ10 in humans) was known for its key role in mitochondrial bioenergetics; later studies demonstrated its presence in other subcellular fractions and in plasma, and extensively investigated its antioxidant role. These two functions constitute the basis on which research supporting the clinical use of CoQ10 is founded. Also at the inner mitochondrial membrane level, coenzyme Q is recognized as an obligatory co-factor for the function of uncoupling proteins and a modulator of the transition pore. Furthermore, recent data reveal that CoQ10 affects expression of genes involved in human cell signalling, metabolism, and transport and some of the effects of exogenously administered CoQ10 may be due to this property. Coenzyme Q is the only lipid soluble antioxidant synthesized endogenously. In its reduced form, CoQH2, ubiquinol, inhibits protein and DNA oxidation but it is the effect on lipid peroxidation that has been most deeply studied. Ubiquinol inhibits the peroxidation of cell membrane lipids and also that of lipoprotein lipids present in the circulation. Dietary supplementation with CoQ10 results in increased levels of ubiquinol-10 within circulating lipoproteins and increased resistance of human low-density lipoproteins to the initiation of lipid peroxidation. Moreover, CoQ10 has a direct anti-atherogenic effect, which has been demonstrated in apolipoprotein E-deficient mice fed with a high-fat diet. In this model, supplementation with CoQ10 at pharmacological doses was capable of decreasing the absolute concentration of lipid hydroperoxides in atherosclerotic lesions and of minimizing the size of atherosclerotic lesions in the whole aorta. Whether these protective effects are only due to the antioxidant properties of coenzyme Q remains to be established; recent data point out that CoQ10 could have a direct effect on endothelial function. In patients with stable moderate CHF, oral CoQ10 supplementation was shown to ameliorate

  9. Co-opting psychiatry: the alliance between academic psychiatry and the pharmaceutical industry.

    PubMed

    Moncrieff, Joanna

    2007-01-01

    The editorial presents the arguments that an alliance between academic psychiatry and the pharmaceutical industry is harmful through a critical review of the academic literature and media coverage of activities of the pharmaceutical industry. The industry and the psychiatric profession both gain advantages from promoting biomedical models of psychiatric disturbance and pharmacological treatment. This confluence of interests has lead to the exaggeration of the efficacy of psychiatric drugs and neglect of their adverse effects and has distorted psychiatric knowledge and practice. Academic psychiatry has helped the industry to colonise more and more areas of modern life in order to expand the market for psychotropic drugs. Persuading people to understand their problems as biological deficiencies obscures the social origin and context of distress and prevents people from seeking social or political solutions. Psychiatry has the power to challenge the dominance of the pharmaceutical industry and should put its efforts into developing alternatives to routine drug treatment. Psychiatry needs to disengage from the industry if it wants to make genuine advances in understanding psychiatric disorder and help reverse the harmful social consequences of the widening med-icalisation of human experience.

  10. The role of the pharmaceutical industry in teaching psychopharmacology: a growing problem.

    PubMed

    Brodkey, Amy C

    2005-01-01

    To describe and examine the role of the pharmaceutical industry in the teaching of psychopharmacology to residents and medical students and to make recommendations for changes in curriculum and policy based on these findings. Literature reviews and discussions with experts, educators, and trainees. The pharmaceutical industry currently plays an extensive role in teaching psychopharmacology to trainees, both directly and indirectly. Attendance at industry-sponsored lectures and drug lunches, meetings with pharmaceutical representatives, and interactions involving the acceptance of various gifts are the most obvious venues. Less apparent but equally pervasive are the influence of industry-sponsored faculty and research and industry's effect on the climate of practice and the profession as a whole. Replacing medical education with industry promotion in the guise of scholarship causes demonstrable harm to trainees, the public, and the profession. In light of these findings, the medical profession must reassert control of medical education and draw a firm barrier between commercial and professional pursuits. These issues must be actively, explicitly, and rigorously discussed with our colleagues and students.

  11. Public Perceptions of Physician – Pharmaceutical Industry Interactions: A Systematic Review

    PubMed Central

    Arkinson, Janine; Holbrook, Anne; Wiercioch, Wojciech

    2010-01-01

    Background: Interactions between physicians and the pharmaceutical industry have led to concerns about conflict of interest (COI), resulting in COI guidelines that suggest a threshold beyond which interactions may be considered unacceptable. Guidelines have also outlined the importance of public opinion on the topic. Consequently, we conducted a systematic review to determine the Canadian public's opinions of physician–pharmaceutical industry interactions. Methods: A systematic review of the standard health sciences literature as well as grey literature was conducted and a number of experts were contacted. Pre-determined eligibility criteria were used to identify appropriate studies. Meta-analysis of the study findings was not possible owing to the variety of methods of reporting outcomes, the types of interactions studied and the diversity of populations studied. Results: No studies on Canadian opinions were identified. Ten international studies (n=13,637), seven with patient groups and three with public citizens, were identified that examined opinions on aspects of awareness, acceptability, disclosure and perceived effects of physician–pharmaceutical industry interactions. Heterogeneity was observed in the awareness, acceptability and perceived effects of physician–pharmaceutical industry interactions; however, there appeared to be greater acceptability and fewer perceived effects with smaller, less costly interactions that directly benefit patients or a medical practice. Desire for disclosure of these interactions was consistent across studies. Interpretation: Research on the public's perception of physician–pharmaceutical industry interactions has been inadequate internationally and non-existent in Canada, and is urgently needed to help shape policies regarding potential conflict of interest. PMID:21532771

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed

    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.

  15. Pharmacist, the pharmaceutical industry and pharmacy education in Saudi Arabia: A questionnaire-based study

    PubMed Central

    Bin Saleh, Ghada; Rezk, Naser L.; Laika, Laila; Ali, Anna; El-Metwally, Ashraf

    2015-01-01

    Background: In Saudi Arabia there is an estimated need of more than 100,000 pharmacy graduates to cover all present sectors. The shortage of pharmacists has affected many of these sectors especially the pharmaceutical industry. The contribution of Saudi pharmacists to local pharmaceuticals industry would be extremely beneficial and important for shaping the future of the drug industry within the Kingdom. It is not clear whether future Saudi pharmacists are willing to contribute to local pharmaco-industrial fields. Methods: A cross-sectional, questionnaire-based survey was conducted on all final-year pharmacy students in King Saud University (KSU), Riyadh, Kingdom of Saudi Arabia (KSA). Results: Out of a total of 130 students registered in the final-year of the pharmacy program in KSU, 122 (93.8%) were able to complete the questionnaire. The results showed that the majority (83%) of Saudi pharmacy students indicated that they had not received practical training in the pharmaceutical companies, while only 17.2% of the students felt that they had the knowledge and the skills to work in the pharmaceutical industry after graduation. The majority of the students (66.7%) chose clinical pharmacy as their future career field while only 10.9% indicated willingness to work in a pharmaceutical industry career. Only 8.2% selected working in the pharmaceutical industry. The significant predictor of possibly choosing a career in the local drug industry is a student with a bachelor’s degree (compared to Pharm D degree) in pharmacy (OR = 2.7 [95% CI 1.1–6.3]). Conclusion: Pharmacy students who are enrolled in the capital city of Riyadh are not properly trained to play an influential role in local drug companies. As a result, their level of willingness to have a career in such important business is not promising (more among Pharm D program). Future research in other pharmacy colleges within Saudi Arabia is needed to confirm such results. PMID:26594125

  16. Was Part D a giveaway to the pharmaceutical industry?

    PubMed

    Newhouse, Joseph P; Seiguer, Erica; Frank, Richard G

    2007-01-01

    The Medicare Modernization Act (MMA) prohibited the government from negotiating drug prices, a feature that the act's critics characterize as a giveaway to the drug industry. Instead of the government negotiating to keep prices down, the act relies on competition among drug companies to obtain business from private insurers; yet, competition cannot be effective when there are no close clinical substitutes. In the past few years, the rate of introduction of first-in-class drugs has been low; if this continues, the prohibition on negotiation may be only a minor problem. However, if the prior rate of introduction resumes, the government may find itself with unacceptable expenditure levels.

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

    PubMed

    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.

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

    PubMed

    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.

  19. The hidden curriculum: medical students' changing opinions toward the pharmaceutical industry.

    PubMed

    Fitz, Matthew M; Homan, David; Reddy, Shalini; Griffith, Charles H; Baker, Elizabeth; Simpson, Kevin P

    2007-10-01

    Authorities suggest academic medical centers eliminate conflicts of interest. The authors evaluated medical students' opinions and knowledge of the pharmaceutical industry. An anonymous 20-item questionnaire was administered to medical students from four different medical schools; 15 items addressed opinions, and five items were free-response knowledge questions. Results were analyzed by Fisher exact test. Authors received 667 responses from the schools. Sixty-five percent of clinical students believed accepting gifts was appropriate; 28% of preclinical students believed it was appropriate (P < .001). Knowledge was the same for clinical and preclinical students. Clinical students were more favorable toward receiving gifts than were preclinical students, yet there was no difference in their knowledge of the industry. Increased formal and informal education about the pharmaceutical industry is necessary during the clinical years.

  20. High reprint orders in medical journals and pharmaceutical industry funding: case-control study.

    PubMed

    Handel, Adam E; Patel, Sunil V; Pakpoor, Julia; Ebers, George C; Goldacre, Ben; Ramagopalan, Sreeram V

    2012-06-28

    To assess the extent to which funding and study design are associated with high reprint orders. Case-control study. Top articles by size of reprint orders in seven journals, 2002-09. Lancet, Lancet Neurology, Lancet Oncology (Lancet Group), BMJ, Gut, Heart, and Journal of Neurology, Neurosurgery & Psychiatry (BMJ Group) matched to contemporaneous articles not in the list of high reprint orders. Funding and design of randomised controlled trials or other study designs. Median reprint orders for the seven journals ranged from 3000 to 126,350. Papers with high reprint orders were more likely to be funded by the pharmaceutical industry than were control papers (industry funding versus other or none: odds ratio 8.64, 95% confidence interval 5.09 to 14.68, and mixed funding versus other or none: 3.72, 2.43 to 5.70). Funding by the pharmaceutical industry is associated with high numbers of reprint orders.

  1. [The pharmaceutical industry during the Second World War: issues and evolution].

    PubMed

    Bonnemain, Bruno

    2002-01-01

    During the Second World War, French pharmaceutical industry was facing several crises at the same time: economic, social and political crisis, in its relationship with the German occupying forces and the Vichy regime. However, the industrial pharmacy continued its investments and innovation: several specialties were born. Other specialties are largely increasing their sales as they replace missing food (sugar, oil). Relationship with the occupying forces are first to try to escape constraints that are imposed to the companies. But contracts signed with German companies are obviously related to the defeated position of France. Allied are also a source of breach between French companies and their subsidiaries abroad (UK or USA). In this context, the new French law of September 11, 1941 on French Pharmacy appears for Vichy's regime and German occupying forces as a way among others to control the French pharmaceutical industry.

  2. Exploring Perceptions of Early-Career Psychiatrists About Their Relationships With the Pharmaceutical Industry.

    PubMed

    Stark, Thomas Johann; Brownell, Alvin Keith; Brager, Nancy Patricia; Berg, Amanda; Balderston, Rhea; Lockyer, Jocelyn Margot

    2016-04-01

    The pharmaceutical industry has engaged physicians through medical education, patient care, and medical research. New conflict of interest policy has highlighted the challenges to these relationships. The objective of this study was to explore the perceptions that early career psychiatrists (e.g. those within 5 years of entering practice) have regarding their relationship with the pharmaceutical industry. Data were collected through semi-structured interviews and were analysed using a grounded theory methodology. Interviews were conducted and analyzed in an iterative way using a constant comparison approach in which data were collected and open coded for themes and subthemes. As new interviews were conducted, the themes were applied to data along with emergent themes and previous interviews recoded until additional interviews failed to provide new themes and thematic saturation was achieved. Through axial coding, a process of relating codes (categories and concepts) to each other, the theory was generated to explain the core variable mediating perceptions participants had about the relationship with industry. The participants described increasing frequency of experiences with industry throughout training into practice. Their perceptions developed through training, physician culture, industry promotion, and their own practices. In managing the relationship with industry, participants would either avoid interactions or engage in behaviors aimed to reduce the risk of influence. Maintaining one's professional integrity was the underlying driver used to manage the relationship with industry. Psychiatrists develop perceptions about industry through experience and observation leading them to develop their own strategies to manage these relationships while maintaining their professional integrity.

  3. Refinement and validation of an exposure model for the pharmaceutical industry.

    PubMed

    McDonnell, Patricia E; Cherrie, John W; Sleeuwenhoek, Anne; Gilles, Andy; Coggins, Marie A

    2011-03-01

    Assessment of worker's exposure is becoming increasingly critical in the pharmaceutical industry as drugs of higher potency are being manufactured. The batch nature of operations often makes it difficult to obtain sufficient numbers of exposure measurements and occupational exposure models may be useful tools in the exposure assessment process. This paper aims to describe further refinement and validation of an existing deterministic occupational exposure model to predict airborne exposure of workers in this industry. Workplace exposure assessment data (n = 381) containing all the contextual information required for the exposure model were collated from a multinational pharmaceutical company. The measured exposure levels ranged from 5 × 10⁻⁷ to 200 mg m⁻³ for largely task based samples, and included a range of handling activities, local control measures and abnormal operating conditions. Model input parameters for local control measures and handling activities were refined to reflect pharmaceutical situations. The refined exposure model resulted in good correlations between the log-transformed model predictions and the actual measured data for the overall dataset (r(s) = 0.61, n = 381, p < 0.001) and at scenario level (r(s) = 0.69, n = 48, p < 0.001). The model overestimated scenarios with measured exposure levels < 0.1 mg m⁻³ (r(s) = 0.69, bias = 0.71, n = 46, p < 0.001), and underestimated scenarios with higher measured concentrations ( > 0.1 mg m⁻³) (r(s) = 0.59, bias = -4.9, n = 33, p < 0.001). Including information on the refined sub-parameters improved the correlations, suggesting the uncertainty in the model parameters was partly responsible for the bias. Further scientific data from the pharmaceutical industry on model input parameters, particularly on the efficacy of local control measures, may help improve the accuracy of the model predictions. The refined exposure model appears to be a useful exposure assessment screening tool for the

  4. An improved synthesis of the "miracle nutrient" coenzyme Q10.

    PubMed

    Lipshutz, Bruce H; Lower, Asher; Berl, Volker; Schein, Karin; Wetterich, Frank

    2005-09-15

    [reaction: see text] A new route to the key coupling partner, chloromethylated CoQ0 (1), allows for direct formation of CoQ10 (3) via nickel-catalyzed cross-coupling with the side chain in the form of an in situ-derived vinyl alane (2).

  5. [Effect of coenzyme Q10 in patients with kidney diseases].

    PubMed

    Gazdíková, K; Gvozdjáková, A; Kucharská, J; Spustová, V; Braunová, Z; Dzúrik, R

    2001-05-24

    Coenzyme Q10 belongs to important antioxidants and it has a key role in the synthesis of adenosinetriphosphate. Its beneficial effect was proved in several diseases, e.g. in mitochondrial encephalopathy, mitochondrial myopathy, mitochondrial cardiomyopathy. All 15 patients of the studied group (5 with tubulopathy and 10 with chronic tubulointersticial nephritis) received antioxidative therapy for three months (E vitamin, C vitamin, riboflavin) and for the last two months coenzyme Q10 was added. Renal functions, spectrum of lipids, parameters of lipid peroxidation (malondialdehyde), levels of alpha-tocopherol, beta-carotene, coenzyme Q10. Before the substitutive antioxidative treatment, coenzyme Q10 levels reached in blood 0.11 +/- 0.03 mumol/l and 0.15 +/- 0.04 mumol/l in plasma. These values were well below the reference range (rr) is 0.4 +/- 1.0 mumol/l). After the substitution coenzyme Q10 levels significantly increased (p < 0.001) to the values of 1.66 +/- 0.16 mumol/l in blood and to 1.78 +/- 0.27 mumol/l in plasma. Plasma levels of beta-carotene increased from the markedly subnormal values 0.25 +/- 0.07 mumol/l (rr > 0.8 mumol/l) to 0.56 +/- 0.02 mumol/l (no statistical difference). Plasma levels of alpha-tocopherol remained within the reference range 32.15 +/- 4.73 mumol/l (rr 15-30 mumol/l) and they increased up to the plasma level of 44.83 +/- 5.82 mumol/l during the period of testing. Malondialdehyde levels did not significantly change within the testing period. No changes in renal functions and parameters of lipid metabolism were described. Patients well tolerated the treatment and no adverse effects were seen during the period of observation. Our results ascertained that levels of antioxidant CoQ10 were lower in patients with nephropathy who underwent conservative treatment with peroral substation. Such deficit can be amended by CoQ10 administration, which could be therefore taken as complementary treatment of nephrology.

  6. A measure of productivity and innovation in the pharmaceutical industry 2011-2015.

    PubMed

    Harrison, R

    2016-11-01

    The pharmaceutical industry has faced enormous pressures over the last few decades. Declining revenues, increasing payer pressures, and a constantly changing regulatory landscape have forced all companies to identify processes to increase productivity and innovation. However, to date, no one agrees on precisely how to measure these attributes or how to interpret these results to understand the state of the industry. We propose new quantitative measures of productivity and innovation and use these to illustrate an industry that has in recent years become more innovative and productive after years of decline. Copyright 2016 Prous Science, S.A.U. or its licensors. All rights reserved.

  7. The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations.

    PubMed

    Kelleher, Finnuala

    2004-01-01

    Pharmaceutical companies increasingly perform clinical trials in developing nations. Governments of host nations see the trials as a way to provide otherwise unaffordable medical care, while trial sponsors are drawn to those countries by lower costs, the prevalence of diseases rare in developed nations, and large numbers of impoverished patients. Local governments, however, fail to police trials, and the FDA does not monitor trials in foreign countries, resulting in the routine violation of international standards for the protection of human subjects. This Note proposes independent accreditation of those institutions involved in clinical trials--the institutional review boards which oversee trial protocol; the organizations, such as pharmaceutical companies, which sponsor the trials; and the research organizations that conduct the trials. Accreditation, similar to that used in the footwear and apparel industries, would increase the transparency of pharmaceutical trials and would enable the United States government and consumers to hold trial sponsors accountable for their actions.

  8. Health care reform and the pharmaceutical industry: crucial decisions are expected.

    PubMed

    Liberman, Aaron; Rubinstein, Jason

    2002-03-01

    For the past 30 years, the largest growing segment of the United States economy is the health care industry. The United States is in a transitional period as American citizens born between 1946 and 1964, the Baby Boomer generation, reach retirement age. In recent years, pharmaceutical costs have been rising faster than the inflation rate, leaving the American public to ask many questions. A major area of interest to policymakers regarding the health care reform agenda is patient spending on pharmaceutical items. Government-funded programs such as Medicare and Medicaid are facing the possibility of running out of funds and require substantive reform. Pharmaceuticals are not covered under the basic Medicare programs. As a result, senior citizens are forced to cover their prescription expenses out of pocket or purchase supplemental insurance plans. This extra expense is leaving many senior citizens across the country struggling to support their ongoing medical needs.

  9. High rate composting of herbal pharmaceutical industry solid waste.

    PubMed

    Ali, M; Duba, K S; Kalamdhad, A S; Bhatia, A; Khursheed, A; Kazmi, A A; Ahmed, N

    2012-01-01

    High rate composting studies of hard to degrade herbal wastes were conducted in a 3.5 m(3) capacity rotary drum composter. Studies were spread out in four trials: In trial 1 and 2, one and two turns per day rotation was observed, respectively, by mixing of herbal industry waste with cattle (buffalo) manure at a ratio of 3:1 on wet weight basis. In trial 3 inocula was added in raw waste to enhance the degradation and in trial 4 composting of a mixture of vegetable market waste and herbal waste was conducted at one turn per day. Results demonstrated that the operation of the rotary drum at one turn a day (trial 1) could provide the most conducive composting conditions and co-composting (trial 4) gave better quality compost in terms of temperature, moisture, nitrogen, and Solvita maturity index. In addition a FT-IR study also revealed that trial 1 and trial 4 gave quality compost in terms of stability and maturity due to the presence of more intense peaks in the aromatic region and less intense peaks were found in the aliphatic region compared with trial 2 and trial 3.

  10. Automatic plaque assay for the pharmaceutical industry using machine vision

    NASA Astrophysics Data System (ADS)

    Wilder, Joseph; Tsai, Augustine; Festa, J. M.

    1995-10-01

    A crucial step in the manufacture of vaccines is the verification of their potency. An assay of the potency must be carried out on every batch produced to determine the safety and efficacy of the vaccine. Currently, human inspectors count the number of plaques (holes) in a cell layer in a petri dish to estimate the potency.They must determine whether nearby plaques that have overgrown each other's borders are single or multiple plaques and distinguish between plaques and small tears in the cell layer resulting from the processing operations (the edges of tears differ in appearance from the edges of plaques). Because of the judgments required to make these subtle distinctions, human inspectors are inconsistent. In cooperation with Merck & Co., Inc., the Rutgers University Center for Computer Aids for Industrial Productivity has demonstrated the feasibility of achieving consistent automatic counting of plaques by a prototype intelligent machine vision system. The David Sarnoff Research Center developed materials handling equipment and factory information system interfaces to enable this prototype system to be installed in a quality control facility at Merck. This paper describes the overall operation of the machine vision aspects of the system, including optics, illumination, sensing, preprocessing, feature extraction and shape recognition. Results of initial tests of the system are also reported.

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

    PubMed Central

    2014-01-01

    Background 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). Results 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. Conclusion 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. PMID:24708770

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

    PubMed

    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.

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

    PubMed

    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

  14. Transformation in the pharmaceutical industry: transformation-induced quality risks--a survey.

    PubMed

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

    2013-01-01

    This paper is the fourth in a series that explores ongoing transformation in the pharmaceutical industry and its impact on pharmaceutical quality from the perspective of risk identification. The aim of this paper is to validate proposed quality risks through elicitation of expert opinion and define the resultant quality risk model. Expert opinion was obtained using a questionnaire-based survey with participants with recognized expertise in pharmaceutical regulation, product lifecycle, or technology. The results of the survey validate the theoretical and operational evidence in support of the four main pharmaceutical transformation triggers previously identified. The quality risk model resulting from the survey indicated a firm relationship between the pharmaceutical quality risks and regulatory compliance outcomes during the marketing approval and post-marketing phases of the product lifecycle and a weaker relationship during the pre-market evaluation phase. In this paper through conduct of an expert opinion survey the proposed quality risks carried forward from an earlier part of the research are validated and resultant quality risk model is defined. The survey results validate the theoretical and operational evidence previously identified. The quality risk model indicates that transformation-related risks have a larger regulatory compliance impact during product approval, manufacturing, distribution, and commercial use than during the development phase.

  15. [Approval of drugs by national and European agencies--sequelae for the pharmaceutical industry].

    PubMed

    Zierenberg, O

    1997-11-01

    The research-based pharmaceutical industry supports the European harmonization process for the granting of pharmaceutical registrations. In order to improve consumer protection and the therapeutic options available to physicians in comparison to nationally registered products, the harmonization must be carried out on schedule and transparently a high scientific standard. It must not lead to the adoption of all national restrictions regarding data sheets and patient leaflets. Pharmaceutical products with the same ingredients can be registered either through the national or through the European procedure. This situation can only be remedied by the harmonization of core SPCs. This process must be agreed in consultation between pharmaceutical companies and regulatory authorities. With regard to measures to avert drug risks, professional associations and the pharmaceutical companies affected should be heard by the national authorities and their arguments given due consideration. In addition, national authorities and the CPMP must coordinate their decisions before they are published. In particular, the basis of these decisions should be made clear and therapeutic alternatives should be known.

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

    PubMed

    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.

  17. Eliciting views of Australian pharmaceutical industry employees on collaboration and the concept of Quality Use of Medicines.

    PubMed

    Wang, N; Lipworth, W L; Ritchie, J E; Williams, K M; Day, R O

    2011-04-01

    Pharmaceutical industry involvement in biomedicine has produced major benefits but has also caused concern. At present, there is no consensus as to how medical and government organizations should relate to the pharmaceutical industry and this is partly due to the absence of systematic study of the various alternatives. In Australia industry cooperation has been elicited through the 'Quality Use of Medicines' (QUM) framework within the 'National Medicines Policy'. Little is known about the way employees of pharmaceutical companies respond to the QUM policy and strategies. To examine the engagement of the Australian pharmaceutical industry with QUM with a view to assisting medical, government and consumer organizations who may wish to collaborate with industry. We carried out a qualitative study using in-depth, semistructured interviews with industry employees, primarily from medical and regulatory affairs departments. Employees of pharmaceutical companies claim that collaboration is important, and that they are altruistic and committed to QUM. At the same time, there is little evidence from this study to support the notion that QUM has brought about structural changes to industry or is positioned as the central goal or framework in designing a company's operational strategies. Moreover, there is a significant degree of ambivalence towards governments and medical organizations. Employees within the pharmaceutical industry claim a commitment to collaboration and QUM. While these claims cannot be taken entirely at face value, there is potential for meaningful collaboration with industry. © 2011 The Authors. Internal Medicine Journal © 2011 Royal Australasian College of Physicians.

  18. Peering into the pharmaceutical "pipeline": investigational drugs, clinical trials, and industry priorities.

    PubMed

    Fisher, Jill A; Cottingham, Marci D; Kalbaugh, Corey A

    2015-04-01

    In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry's investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding--and often problematic--role of pharmaceuticals in society. To access the pharmaceutical industry's pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2477 different drugs in 4182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline was being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered.

  19. Health advocacy organizations and the pharmaceutical industry: an analysis of disclosure practices.

    PubMed

    Rothman, Sheila M; Raveis, Victoria H; Friedman, Anne; Rothman, David J

    2011-04-01

    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.

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

    PubMed Central

    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

  1. Barriers to Alzheimer disease drug discovery and drug development in the pharmaceutical industry.

    PubMed

    Anand, Ravi

    2002-01-01

    The drug development process in the pharmaceutical industry has evolved from separate programs, specific for each country, into one coordinated, global development scheme. As a result, such a development program must meet regulatory requirements for all countries in which approval for the new drug will be sought. Barriers to Alzheimer disease (AD) drug discovery and development in the pharmaceutical industry can be categorized as (1) regulatory, (2) logistical, and (3) drug development issues. Some of the regulatory barriers could be overcome by international harmonization of guidelines for the development of antidementia drugs. The logistical issues can be reduced through international collaboration in the conduct of clinical studies, and the developmental issues can be addressed by using an expedited drug development plan that not only can reduce the time but also the resources required to develop the drug.

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

    PubMed

    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.

  3. [Bitter and gilded pills: psychiatry in the light (or shadow) of the pharmaceutical industry].

    PubMed

    Vandereycken, W

    2006-01-01

    Psychotropic medication has brought about far-reaching changes in psychiatry: in its nature and practice, its image of man and its public image. Never before have so many psychotropic drugs been prescribed for young people. 'Difficult' children are now referred to as ADHD children and moody youngsters are given antidepressants. In adult psychiatry treatment is being dictated more and more by protocols and guidelines: very often medication is the treatment of choice. The reasons for this are largely economic. Increasingly 'research' is being sponsored by the pharmaceutical industry. Published research results are often skewed so as to favour the sponsor. Some scientific journals owe their survival to drug advertisements. Even some patient organisations are supported by the pharmaceutical industry. How will psychiatry and mental health care be able to escape from this 'straightjacket' in the future? The purpose of this polemical essay is to draw the attention of health care professionals and researchers to this rather worrying development.

  4. Price-cost margin in the pharmaceutical industry. Empirical evidence from Finland.

    PubMed

    Linnosmaa, Ismo; Hermans, Raine; Hallinen, Taru

    2004-06-01

    This contribution estimates the price-cost margin in the Finnish pharmaceutical industry. The estimation is based on the method developed by Hall who shows that under constant returns to scale total factor productivity growth depends on the growth of output-capital ratio if the market is imperfectly competitive. Measurement of the price-cost margin is based on this theoretical result. We utilize data on the Finnish pharmaceutical industry. The data cover the years 1975-1999 and include information on output, labor hours, and capital stock. The results show that the estimated price-cost margin is in the range 0.59-0.67, which is close to the estimates obtained in the United States market.

  5. Braving a faceless new world? Conceptualizing trust in the pharmaceutical industry and its products.

    PubMed

    Brown, Patrick; Calnan, Michael

    2012-01-01

    Pharmaceutical products are commonly relied upon by professionals, and correspondingly patients, within a wide range of healthcare contexts. This dependence, combined with the inherent risk and uncertainty surrounding both medical practice and the drugs it harnesses, points towards the importance of trust in the pharmaceutical industry--a subject which has been much neglected by researchers. This article begins to address this deficiency by mapping out a conceptual framework which may form a useful basis for future research into this important topic. The often negative portrayal of the pharmaceutical industry in the public sphere belies a state of apparent confidence in its products. The role of prescribing professionals as 'mediators of trust' amid a faceless system of production and, alongside regulators, as bases of assurance in the quality of drugs goes some way towards explaining this contradiction. Recent policy moves towards fostering increased patient 'expertise' and responsibility for illness management, a widening of over-the-counter medication availability and a growing market of products (mainstream and illicit) via the Internet suggest this role of 'facework' in facilitating trust may be becoming more marginal. This heightened requirement for trusting amid the unfamiliar, and an apparent willingness to do so, underlines the need for further research into trust in the industry--both mainstream and underground--and its products. Within this discussion an agenda for furthering our understandings of the political-economy of the pharmaceutical industry becomes apparent, one which might be most effectively approached by way of a broader political-economy of hope and trust.

  6. Prerequisites for the pharmaceutical industry to develop and commercialise helminths and helminth-derived product therapy.

    PubMed

    Tilp, Cornelia; Kapur, Vishal; Loging, Will; Erb, Klaus J

    2013-03-01

    During the past 10 years, immunologists, epidemiologists and parasitologists have made many new exciting discoveries in the field of helminth-mediated immune regulation. In addition, many animal experiments have shown that certain helminths or products derived from helminths can protect mice from developing allergic or autoimmune disease. Some clinical trials utilising Trichuris suis or Necator americanus for the treatment of allergic disorders and inflammatory bowel disease have been conducted. The outcomes of these trials suggest that they may be used to treat these disorders. However, to date no helminth therapy is routinely being applied to patients and no helminth-derived product therapy has been developed. In order to bring new drugs to the market and shoulder the enormous costs involved in developing such therapies, pharmaceutical companies need to be involved. However, currently the resources from the pharmaceutical industry devoted to this concept are relatively small and there are good reasons why the industry may have been reluctant to invest in developing these types of therapies. In this review article, the hurdles that must be overcome before the pharmaceutical industry might invest in these novel therapies are outlined. Copyright © 2013 Australian Society for Parasitology Inc. Published by Elsevier Ltd. All rights reserved.

  7. Building the world's supply of quinine: Dutch colonialism and the origins of a global pharmaceutical industry.

    PubMed

    Goss, Andrew

    2014-03-01

    Quinine, a naturally occurring alkaloid from the Cinchona tree, was one of the first drugs produced and sold by a global pharmaceutical industry during the nineteenth century. Factories in Europe and North America dominated the manufacturing industry, and between 1890 and 1940, Cinchona plantations on Java supplied most of the bark for the quinine pharmaceutical business. At the end of the nineteenth century, the Dutch colonial state kept a hands-off approach to the Cinchona enterprises, in keeping with its liberal orientation. But the persistent low-price for bark, which led to the near ruin of the Cinchona planters, eventually pushed the colonial state to actively protect the Cinchona plantations. Colonial officials sought to stabilize the colonial Cinchona export-business by encouraging the integration of the quinine industry on a global scale. Most important was the colonial state's sponsorship in 1913 of the Quinine Agreement, establishing a set price for Cinchona bark, which created the world's first pharmaceutical cartel. In the interwar period, an alliance of Dutch government officials, planters, scientists, doctors and drug-makers, working in both the motherland and the colony, actively promoted the expansion of quinine consumption, as well as the merit of the Quinine Agreement, which they argued supplied guaranteed a steady supply of quinine, all for the wellbeing of global humanity. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

    PubMed

    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.

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

    PubMed

    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.

  10. Economic analysis of final effluent limitations guidelines and standards for the pharmaceutical manufacturing industry

    SciTech Connect

    1998-07-01

    This economic analysis (EA) examines compliance costs and economic impacts resulting from the US Environmental Protection Agency`s (EPA`s) Final Effluent Limitations Guidelines and Standards for the Pharmaceutical Manufacturing Industry Point Source Category. It also investigates the costs and impacts associated with an air rule requiring Maximum Achievable Control Technology (MACT) to control air emissions, both separately and together with the Final Pharmaceutical Industry Effluent Guidelines. The EA estimates the economic effects of compliance with both final rules in terms of total aggregate annualized costs of compliance, facility closures, impacts on firms (likelihood of bankruptcy and effects on profit margins), and impacts on new sources. The EA also investigates secondary impacts on employment and communities, foreign trade, specific demographic groups, and environmental justice. This report includes a Final Regulatory Flexibility Analysis (FRFA) detailing the impacts on small businesses within the pharmaceutical industry to meet the requirements of the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA). Finally, the EA presents a cost-benefit analysis to meet the requirements of Executive Order 12866 and the Unfunded Mandates Reform Act.

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

    PubMed

    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.

  12. Cooperative partnerships or conflict-of-interest? A national survey of interaction between the pharmaceutical industry and medical organizations.

    PubMed

    Kerridge, I; Maguire, J; Newby, D; McNeill, P M; Henry, D; Hill, S; Day, R; Macdonald, G; Stokes, B; Henderson, K

    2005-04-01

    There is extensive and varied interaction between the pharmaceutical industry and the medical profession. Most empirical research concerns contact between individual physicians and industry, and reflects North American experience. We sought to clarify the extent and nature of relationships between the pharmaceutical industry and Australian medical organizations. We administered questionnaires to 63 medical organizations concerned with clinical practice, continuing medical education or professional accreditation, or the political representation of medical professionals. Survey instruments were received from 29 organizations, giving a response rate of 46%. Seventeen of these organizations (59%) had received support from one or more pharmaceutical company in the past financial year. Support was predominantly for annual conferences, with some support for continuing medical education, research, travel and library purchases. The majority of organizations had an academic journal or newsletter, and 10 (34%) accepted revenue from pharmaceutical advertising. Twenty organizations (72%) had policies or guidelines covering their relationship with industry. Few organizations indicated that they would be unable to continue their activities without pharmaceutical industry support. These data indicate a high level of inter-action between the pharmaceutical industry and medical organizations in Australia. While most organizations have policies for guiding their relationship with industry, it is unclear whether these are effective in preventing conflicts of interest and maintaining public trust.

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

    PubMed

    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

  14. A cross-sectional analysis of pharmaceutical industry-funded events for health professionals in Australia.

    PubMed

    Fabbri, Alice; Grundy, Quinn; Mintzes, Barbara; Swandari, Swestika; Moynihan, Ray; Walkom, Emily; Bero, Lisa A

    2017-06-30

    To analyse patterns and characteristics of pharmaceutical industry sponsorship of events for Australian health professionals and to understand the implications of recent changes in transparency provisions that no longer require reporting of payments for food and beverages. Cross-sectional analysis. 301 publicly available company transparency reports downloaded from the website of Medicines Australia, the pharmaceutical industry trade association, covering the period from October 2011 to September 2015. Forty-two companies sponsored 116 845 events for health professionals, on average 608 per week with 30 attendees per event. Events typically included a broad range of health professionals: 82.0% included medical doctors, including specialists and primary care doctors, and 38.3% trainees. Oncology, surgery and endocrinology were the most frequent clinical areas of focus. Most events (64.2%) were held in a clinical setting. The median cost per event was $A263 (IQR $A153-1195) and over 90% included food and beverages. Over this 4-year period, industry-sponsored events were widespread and pharmaceutical companies maintained a high frequency of contact with health professionals. Most events were held in clinical settings, suggesting a pervasive commercial presence in everyday clinical practice. Food and beverages, known to be associated with changes to prescribing practice, were almost always provided. New Australian transparency provisions explicitly exclude meals from the reporting requirements; thus, a large proportion of potentially influential payments from pharmaceutical companies to health professionals will disappear from public view. © 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.

  15. Prescription preferences in antipsychotics and attitude towards the pharmaceutical industry in Belgium.

    PubMed

    Cleymans, Stijn; Morrens, Manuel; Bervoets, Chris

    2017-06-01

    The number of antipsychotic prescriptions are increasing rapidly worldwide, a trend which is mainly driven by the steep rise in second-generation antipsychotic (SGA) prescriptions. However, the success of SGA, compared with the older first-generation antipsychotics (FGAs), cannot be explained by evidence. Several studies concluded on equal efficacy of FGA and SGA on positive, negative and cognitive symptoms of schizophrenia. Next to that, the influence of the pharmaceutical industry on prescription behaviour has drawn considerable interest. Therefore, the relationship between antipsychotic prescription patterns and exposure to information directly provided by pharmaceutical companies was studied. A cross-sectional online survey, addressing psychiatrists, general practitioners (GPs) and trainees in Flanders, was carried out. Respondents were questioned about their prescription behaviour, opinion about efficacy of SGA versus FGA and the nature and frequency of their contact with the pharmaceutical industry. Using Spearman's rank correlations and χ(2) tests, the relationship between different variables and group differences were examined. Psychiatrists, GPs and trainees in Flanders clearly favour olanzapine and risperidone, followed by quetiapine and aripiprazole above all other agents. This behaviour is supported by the conviction that SGAs have superior efficacy and a more benign side effect profile, compared with FGA. Frequent contact with drug representatives is correlated with a preference of SGA over FGA. 41% of the respondents acknowledge to be influenced by the pharmaceutical industry, which is more than that previously reported. 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/.

  16. A Study of Attitude and Knowledge of the Psychiatry Resident Doctors toward Clinician-Pharmaceutical Industry Interaction.

    PubMed

    Balhara, Yatan Pal Singh; Mathur, Shachi; Anand, Nikhilesh

    2012-01-01

    Pharmaceutical industry and clinicians are the two important stakeholders in the modern-day health care. However, concerns have been expressed about the lack of congruence between the goals of these two. The current study aimed at exploring the knowledge and attitude of the psychiatry resident doctors toward the clinician-pharmaceutical industry interaction and also at exploring the knowledge of the residents about the new Medical Council of India guidelines on this issue. The survey was conducted among psychiatry residents. Descriptive statistics with frequency distribution was carried out by using SPSS version 17.0. It had a good response rate of around 90%. The survey reveals the knowledge and attitude of the psychiatry residents toward the psychiatrist-pharmaceutical industry interaction. The survey provides understanding in knowledge and attitude of the psychiatry residents towards the psychiatrist-pharmaceutical industry interaction.

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

    PubMed

    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

  18. International experience in controlling pharmaceutical expenditure: influencing patients and providers and regulating industry - a systematic review.

    PubMed

    Lee, Iyn-Hyang; Bloor, Karen; Hewitt, Catherine; Maynard, Alan

    2015-01-01

    To review international policies to control expenditure on pharmaceuticals by influencing the behaviour of patients and providers and regulating the pharmaceutical industry. Systematic review of experimental and quasi-experimental studies. Published studies were identified with an electronic search strategy using MEDLINE and EMBASE from 1980 to May 2012. Studies were eligible if they assessed the effect of policies aimed at influencing the behaviour of patients and providers, and regulating the pharmaceutical industry. Outcome measures included pharmaceutical expenditure, prices or utilization; other resource use relating to pharmaceuticals; and health outcomes and patients' or providers' behaviour relating to pharmaceutical use. Quality assessment criteria for each study design were developed based on the standard criteria recommended by the Cochrane Effective Practice and Organisation of Care (EPOC) group. The review includes studies based on randomized controlled trials and rigorous quasi-experimental designs (interrupted time-series and controlled before-and-after studies). Studies were excluded if they were conducted within a single hospital or practice; related to pharmaceutical care services or disease management; had less than 6 months of follow-up period (or less than 12 months overall for interrupted time series); if data in controlled before-and-after studies were not collected contemporaneously or if no rationale was stated for the choice of control group; or if relevant and interpretable data were not presented. A total of 255 studies met the inclusion criteria for this review. The majority of the studies relating to patients evaluated cost sharing interventions such as user charges (52 studies). User charges do reduce utilization of pharmaceuticals, and reduce public expenditure by shifting costs to patients. But they reduce the use of essential as well as non-essential drugs, and without adequate exemptions they affect vulnerable groups

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed

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

    PubMed

    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.

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

    PubMed Central

    Nagashekhara, Molugulu; Agil, Syed Omar Syed

    2011-01-01

    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 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. PMID:24826027

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

    PubMed

    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.

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

    PubMed Central

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

    2005-01-01

    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. PMID:15801942

  7. Inhalable dust measurements as a first approach to assessing occupational exposure in the pharmaceutical industry.

    PubMed

    Champmartin, C; Clerc, F

    2014-01-01

    Occupational exposure to active ingredients in the pharmaceutical industry has been the subject of very few published studies. Nevertheless, operations involving active powdered drugs or dusty operations potentially lead to operator exposure. The aim of this study was to collect occupational exposure data in the pharmaceutical industry for production processes involving powdered active ingredients. While the possibility of assessing drug exposure from dust level is examined, this article focuses on inhalable dust exposure, without taking chemical risk into account. A total of 377 atmospheric (ambient and personal) samples were collected in nine drug production sites (pharmaceutical companies and contract manufacturing organizations) and the dust levels were assessed. For each sample, relevant contextual information was collected. A wide range of results was observed, both site- and operation-dependent. Exposure to inhalable dust levels varied from 0.01 mg/m(3)to 135 mg/m(3). Though restricted to dust exposure, the study highlighted some potentially critical situations or operations, in particular manual tasks (loading, unloading, mechanical actions) performed in open systems. Simple preventive measures such as ventilation, containment, and minimization of manual handling should reduce dust emissions and workers' exposure to inhalable dust.

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

    PubMed

    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.

  9. Pursuit of personalized anticancer therapy: leveraging collaboration between academia and the biotech/pharmaceutical industry.

    PubMed

    Buck, Elizabeth; Mulvihill, Mark; Iwata, Kenneth K

    2010-01-01

    Over the past 2 decades, our increased understanding of tumor biology has resulted in the delivery of a new generation of molecularly targeted cancer drugs with greater efficacy and less toxicity. This understanding has also provided pharmaceutical and academic institutions with a greater appreciation for the complexities and challenges associated with discovering and developing molecularly targeted drugs. To deal with the complexities of tumor biology and the associated technologies needed to develop molecularly targeted drugs, there has been increased cooperation and collaboration between academic and pharmaceutical-industry researchers in a broader number of aspects of the drug discovery and development continuum, including structural biology and translational research. This collaborative effort has played a role in molecularly targeted drugs such as cetuximab, trastuzumab, imatinib, and new promising drug candidates such as OSI-906. Cooperative efforts by industry and academia have also provided important insights to optimize the use of such agents in the clinic. This review aims to emphasize the need for academic/industrial collaborations for success and efficiency through the drug discovery and development continuum, and will highlight several examples of collaborations between academic and industrial scientists that facilitated the development of molecularly targeted antitumor agents into the clinic.

  10. [Conflicts of interest in clinical practice. Ethical analysis of some relationships with the pharmaceutical industry].

    PubMed

    Salas, Sofía P; Osorio F, Marcial; Vial C, Pablo; Rehbein V, Ana María; Salas A, Camila; Beca I, Juan Pablo

    2006-12-01

    Sometimes, the prescription practice of physicians can be influenced by factors that are not related to scientific evidence due to the appearance of several conflicts of interest. These conflicts cause social concern and have prompted actions to regulate the ethics of individual and corporative activities related to healthcare. We analyzed the ethical problems involved in the physician-industry relationship. For this purpose, we considered as the main actors related to this problem, the pharmaceutical industry and their marketing strategies, medical doctors and the independence and objectivity that should guide prescriptions and, finally, patients and their right to receive prescriptions based on scientific evidence. From the point of view of the Bioethics principles, Beneficence would not be respected when gifts or other donations received from the industry affect doctor's independence. Non Maleficence principle could be jeopardized if there is an increased risk of treatment failure and finally Justice could be altered if there is a cost increase for either patients or health institutions. As a conclusion, we consider that the presence of conflicts of interest in the relationship of physicians with the pharmaceutical industry is an important ethical problem. In consequence, this group endorses the recommendations of the Chilean Association of Medical Scientific Societies and advices to include ethical guidelines on this topic in the curriculum of medical schools.

  11. Microbial tyrosinases: promising enzymes for pharmaceutical, food bioprocessing, and environmental industry.

    PubMed

    Zaidi, Kamal Uddin; Ali, Ayesha S; Ali, Sharique A; Naaz, Ishrat

    2014-01-01

    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.

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

    PubMed Central

    Zaidi, Kamal Uddin; Ali, Ayesha S.; Ali, Sharique A.; Naaz, Ishrat

    2014-01-01

    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. PMID:24895537

  13. Pharmaceutical industry financial support for medical education: benefit, or undue influence?

    PubMed

    Brody, Howard

    2009-01-01

    Presently, the pharmaceutical industry funds about half of the costs of continuing medical education (CME) programs in the U.S. This contributes to the ethical problems that pervade the relationship between medicine and the pharmaceutical industry: trustworthiness and conflicts of interest. The problems are exacerbated by rationalizations prevalent on both sides that deny the ethical concerns. Commercialism and commercial bias are highly visible at large CME gatherings, and available data, while scanty, back up the view that physician attendees' subsequent prescribing practices are influenced by the commercial message. The industry believes that it will recoup $3.56 in increased sales for every dollar that it invests in CME. New guidelines instituted by the Accreditation Council for Continuing Medical Education (ACCME) in 2004 may succeed in reducing excessive commercial influence, especially since the Department of Health and Human Services has also warned the industry of possible anti-kickback violations if firewalls are not erected between CME funding and marketing of drugs. Critics counter that early indicators of improvement are lacking.

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

    PubMed Central

    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 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. Purpose: The goal of this review paper is to show the present conditions and future trends of the pharmaceutical industry in the U.S. Methodology: 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.). Discussion: 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. Conclusion: Numerous blockbuster drugs will be coming off

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

    PubMed

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

    2017-09-09

    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.

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

    PubMed

    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.

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

    PubMed Central

    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. PMID:26175729

  18. [Medical research and the pharmaceutical industry. Uneasy bedfellows or a prenuptial agreement?].

    PubMed

    Cohen, A F

    2001-07-28

    Recent publications in medical journals and the media seem to indicate that there are a number of major problems in the relationship between researchers and the pharmaceutical sector. Results of research allegedly are influenced or manipulated, the right to publish the results are taken away from the researchers, and all this for money. The underlying data do not seem to indicate that this is a very common problem, but rather a generalisation of incidents. To efficiently develop medicines in future requires an ever-growing amount of academic know-how that these companies simply lack; in modern pharmaceutical development there are many opportunities to connect academic and industrial research programmes, resulting in synergy rather than an academic sell-out. All parties concerned should make transparent and clear agreements.

  19. Process modeling in the pharmaceutical industry using the discrete element method.

    PubMed

    Ketterhagen, William R; am Ende, Mary T; Hancock, Bruno C

    2009-02-01

    The discrete element method (DEM) is widely used to model a range of processes across many industries. This paper reviews current DEM models for several common pharmaceutical processes including material transport and storage, blending, granulation, milling, compression, and film coating. The studies described in this review yielded interesting results that provided insight into the effects of various material properties and operating conditions on pharmaceutical processes. Additionally, some basic elements common to most DEM models are overviewed. A discussion of some common model extensions such as nonspherical particle shapes, noncontact forces, and interstitial fluids is also presented. While these more complex systems have been the focus of many recent studies, considerable work must still be completed to gain a better understanding of how they can affect the processing behavior of bulk solids.

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

    PubMed

    De Ferrari, Aldo; Gentille, Cesar; Davalos, Long; Huayanay, Leandro; Malaga, German

    2014-01-01

    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. To describe physician interactions with and attitudes towards the pharmaceutical industry in a public general hospital in Lima, Peru. 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. 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. 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 and ethically accepted benefit. The attitudes of physicians on the

  1. Attitudes and Relationship between Physicians and the Pharmaceutical Industry in a Public General Hospital in Lima, Peru

    PubMed Central

    De Ferrari, Aldo; Gentille, Cesar; Davalos, Long; Huayanay, Leandro; Malaga, German

    2014-01-01

    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 and ethically accepted

  2. Changing interactions between physician trainees and the pharmaceutical industry: a national survey.

    PubMed

    Austad, Kirsten E; Avorn, Jerry; Franklin, Jessica M; Kowal, Mary K; Campbell, Eric G; Kesselheim, Aaron S

    2013-08-01

    Increasingly, medical school policies limit pharmaceutical representatives' access to students and gifts from drugmakers, but little is known about how these policies affect student attitudes toward industry. To assess interactions between trainees and the pharmaceutical industry, and to determine whether learning environment characteristics influence students' practices and attitudes. We conducted a cross-sectional survey with a nationally-representative sample of first- and fourth-year medical students and third-year residents, stratified by medical school, including ≥ 14 randomly selected trainees at each level per school. We measured frequency of industry interactions and attitudes regarding how such interactions affect medical training and the profession. Chi-squared tests assessed bivariate linear trend, and hierarchical logistic regression models were fitted to assess associations between trainees' attitudes and their schools' National Institutes of Health (NIH) funding levels and American Medical Student Association (AMSA) PharmFree Scorecard grades reflecting industry-related conflict of interest policies. Among 1,610 student (49.3 % response rate) and 739 resident (43.1 %) respondents, industry-sponsored gifts were common, rising from 33.0 % (first-year students) to 56.8 % (fourth-year students) and 54 % (residents) (p < 0.001). These gifts included meals outside the hospital (reported by 5 % first-year students, 13.4 % fourth-year students, 27.5 % residents (p < 0.001)) and free drug samples (reported by 7.4 % first-year students, 14.1 % fourth-year students, 14.3 % residents (p < 0.001)). The perception that industry interactions lead to bias was prevalent, but the belief that physicians receive valuable education through these interactions increased (64.1 % to 67.5 % to 79.8 %, p < 0.001). Students in schools receiving more NIH funding reported industry gifts less often (OR = 0.51, 95 % CI: 0.38-0.68, p < 0.001), but the

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

    PubMed

    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.

  4. High reprint orders in medical journals and pharmaceutical industry funding: case-control study

    PubMed Central

    Handel, Adam E; Patel, Sunil V; Pakpoor, Julia; Ebers, George C; Goldacre, Ben

    2012-01-01

    Objectives To assess the extent to which funding and study design are associated with high reprint orders. Design Case-control study. Setting Top articles by size of reprint orders in seven journals, 2002-09. Participants Lancet, Lancet Neurology, Lancet Oncology (Lancet Group), BMJ, Gut, Heart, and Journal of Neurology, Neurosurgery & Psychiatry (BMJ Group) matched to contemporaneous articles not in the list of high reprint orders. Main outcome measures Funding and design of randomised controlled trials or other study designs. Results Median reprint orders for the seven journals ranged from 3000 to 126 350. Papers with high reprint orders were more likely to be funded by the pharmaceutical industry than were control papers (industry funding versus other or none: odds ratio 8.64, 95% confidence interval 5.09 to 14.68, and mixed funding versus other or none: 3.72, 2.43 to 5.70). Conclusions Funding by the pharmaceutical industry is associated with high numbers of reprint orders. PMID:22745328

  5. Effects of L-carnitine and coenzyme q10 on impaired spermatogenesis caused by isoproterenol in male rats.

    PubMed

    Ghanbarzadeh, S; Garjani, A; Ziaee, M; Khorrami, A

    2014-09-01

    Nowadays, cardiovascular diseases and male infertility are two big health problems in industrial countries.The aim of the present study was to investigate the protective role of coenzyme Q10 and L-Carnitine pretreatment in the impaired spermatogenesis caused by isoproterenol (ISO) in male rats.Thirty-two male Wistar rats were allocated in 4 groups. ISO was injected for 2 consecutive days (100 mg/kg) in ISO treated groups. Before ISO administration, pretreatment with Coenzyme Q10 (10 mg/kg/day) and L-Carnitine (350 mg/kg/day) were conducted for 20 consecutive days. Sex hormones level, malondialdehyde (MDA) and total antioxidant concentration as well as testis, epididymis and seminal vesicle weight were investigated.Increase in the concentration of MDA and decrease in total antioxidant level was observed following ISO administration. Accordingly, the sperm viability as well as testis, epididymis and seminal vesicle weights were decreased. In the case of sex hormones, the testosterone and LH levels were decreased and the concentration of FSH was increased. Pretreatment with L-carnitine and Coenzyme Q10 significantly decreased the MDA level and increased total antioxidant, LH and testosterone levels. Pretreatment with L-carnitine and Coenzyme Q10 also improved semen parameters and organs weight which were impaired by ISO administration.L-carnitine and Coenzyme Q10 pretreatment could protect spermatogenesis in male rats with ISO administration.

  6. A critique of emerging European legislation in the pharmaceutical industry: a clinical trials analysis.

    PubMed

    Murray, Elizabeth; McAdam, Rodney; Burke, Moira T

    2004-01-01

    The objective of this paper is to critique emerging legislation in the pharmaceutical industry, focusing on the clinical trials sector. Possible changes are identified and discussed inrelation to their impact on phase I clinical trials conducted in the UK. It is concluded that smaller contract research organisations, which have benefited in the past from European Union legislative variation, may have resource problems in trying to cope with the changing business environment created through legislative harmonization. These SMEs must use this opportunity to seek clinical trials research partnerships in a new harmonized EU market.

  7. Monitoring versus interim analysis of clinical trials: a perspective from the pharmaceutical industry.

    PubMed

    Enas, G G; Dornseif, B E; Sampson, C B; Rockhold, F W; Wuu, J

    1989-03-01

    The definitions of "interim analysis" and "monitoring" of clinical trials are often ambiguous in the current literature. The resulting confusion can lead to erroneous conclusions and misguided decisions, especially when activities that are operational or observational are evaluated in a probabilistic sense as inferential. The authors seek to define "interim analysis" and "monitoring" in a mutually exclusive fashion. These definitions will then provide the opportunity to review and categorize existing clinical trial practices and procedures. This will clarify such issues as "when to look" and "when to pay a price" (e.g., test size and power) and characterize such issues in the context of pharmaceutical industry drug development.

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

    PubMed

    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.

  9. Fenton-biological treatment processes for the removal of some pharmaceuticals from industrial wastewater.

    PubMed

    Badawy, Mohamed I; Wahaab, Rifaat A; El-Kalliny, A S

    2009-08-15

    A treatability study of pharmaceutical wastewater from El-Nasr Pharmaceutical and Chemical Company, South-East of Cairo, was carried out. The company discharges both industrial (6000 m(3)/d) and municipal wastewater (128 m(3)/d) into a nearby evaporation pond without any treatment. The generated raw wastewater is characterized by high values of COD (4100-13,023), TSS (20-330 mg/L), and oil grease (17.4-600 mg/L). In addition, the presence of refractory compounds decreases BOD/COD ratio (0.25-0.30). Analysis of raw wastewater confirmed that pre-treatment is required prior to discharge into public sewers to comply with the Egyptian Environmental laws and regulations. The obtained results indicated that the refractory compounds and their by-products cannot be readily removed by biological treatment and always remain in the treated effluent or adsorbed on the sludge flocs. The application of Fenton oxidation process as a pre-treatment improved the removal of pharmaceuticals from wastewater and appears to be an affective solution to achieve compliance with the law legislation with respect to discharge in a determined receptor medium.

  10. Pharmacists’ Perceptions of the Influence of Interactions with the Pharmaceutical Industry on Clinical Decision-Making

    PubMed Central

    Tejani, Aaron M; Loewen, Peter; Bachand, Richard; Harder, Curtis K

    2015-01-01

    Background: There is a paucity of literature examining the perceptions of Canadian pharmacists toward drug promotion by the pharmaceutical industry and pharmacist–industry interactions. Objectives: To determine whether hospital pharmacists perceive their interactions with the pharmaceutical industry as influencing their clinical decision-making or that of their colleagues and whether hospital pharmacists perceive that interactions with the pharmaceutical industry create a conflict of interest. Methods: A cross-sectional survey of the complete sample of hospital pharmacists practising in 3 large health authorities in a single Canadian province was conducted from February to April 2010. Results: A total of 224 responses were received from the approximately 480 pharmacists in the target health authorities (response rate approximately 47%). Fifty-eight percent of respondents (127/218) did not believe that information received at industry-sponsored events influenced their clinical decision-making. Most (142/163 [87%]) disagreed that small gifts influenced their clinical decision-making, whereas responses were divided for large gifts. Respondents were also divided on the issue of whether their interactions created conflicts of interest, with most of those who had received gifts agreeing that large gifts would create a conflict of interest (134/163 [82%]) whereas small gifts would not (100/163 [61%]). There were positive correlations between respondents’ beliefs about their own susceptibility to influence from sponsored events or receipt of small or large gifts and the susceptibility of others, but 22% of respondents (28/127) expressed a different perception about sponsored events, all believing themselves to be less influenced than their colleagues. Only 6% (4/64) of those who received large gifts and 4% (5/142) of those who received small gifts and felt they were not influenced by these gifts reported that it was likely others would be influenced by the receipt of

  11. Pharmacists' Perceptions of the Influence of Interactions with the Pharmaceutical Industry on Clinical Decision-Making.

    PubMed

    Tejani, Aaron M; Loewen, Peter; Bachand, Richard; Harder, Curtis K

    2015-01-01

    There is a paucity of literature examining the perceptions of Canadian pharmacists toward drug promotion by the pharmaceutical industry and pharmacist-industry interactions. To determine whether hospital pharmacists perceive their interactions with the pharmaceutical industry as influencing their clinical decision-making or that of their colleagues and whether hospital pharmacists perceive that interactions with the pharmaceutical industry create a conflict of interest. A cross-sectional survey of the complete sample of hospital pharmacists practising in 3 large health authorities in a single Canadian province was conducted from February to April 2010. A total of 224 responses were received from the approximately 480 pharmacists in the target health authorities (response rate approximately 47%). Fifty-eight percent of respondents (127/218) did not believe that information received at industry-sponsored events influenced their clinical decision-making. Most (142/163 [87%]) disagreed that small gifts influenced their clinical decision-making, whereas responses were divided for large gifts. Respondents were also divided on the issue of whether their interactions created conflicts of interest, with most of those who had received gifts agreeing that large gifts would create a conflict of interest (134/163 [82%]) whereas small gifts would not (100/163 [61%]). There were positive correlations between respondents' beliefs about their own susceptibility to influence from sponsored events or receipt of small or large gifts and the susceptibility of others, but 22% of respondents (28/127) expressed a different perception about sponsored events, all believing themselves to be less influenced than their colleagues. Only 6% (4/64) of those who received large gifts and 4% (5/142) of those who received small gifts and felt they were not influenced by these gifts reported that it was likely others would be influenced by the receipt of such gifts. Most hospital pharmacists who

  12. Medicine and pharmacy--facts and myths about the development of an innovative pharmaceutical industry in Poland.

    PubMed

    Kubiak, Włodzimierz

    2005-01-01

    Innovation is fundamental to the pharmaceutical industry and a key to improvements in healthcare. Its effectiveness depends on huge, constant investments in research. This innovative industry directly affects the course of studies in healthcare and medicine. Its efforts translate directly into the length and quality of our lives. For several years now, the progress underway in pharmaceutical industry has produced measurable benefits. Doctors have new pharmaceuticals at their disposal, including many types of antibiotics and anti-viral drugs, vaccines and a wide range of drugs which save lives or make them more comfortable. In the near future, ever more efficient cures for neoplastic, rheumatic, neurological, psychic, metabolic, circulatory or respiratory diseases can be expected. Innovation is necessary. The human population is ageing, and the task of an innovative pharmaceutical industry is to keep it in a good condition. The use of innovative drugs can translate directly into lowering the costs of illness. A continuous reduction in spending on healthcare has been observed. The costs of inventing an innovative drug are enormous though (US dollar 800 million), and studies on a new drug last between 10 and 13 years. An essential element in recovering the incurred costs and ensuring funds needed for new research is protection by patent. Innovative pharmaceutical companies in Poland are committed to increasing the competitiveness and sustaining the development of not only the market, but also the entire pharmaceutical sector. It is a group of companies of crucial importance to the Polish healthcare system, as it influences improvement in the quality of medical services. Through their investments and spending on research and development, innovative companies accelerate economic growth. In Poland, the innovative pharmaceutical industry is represented by the Association of Pharmaceutical Companies Representatives in Poland (SPFFwP).

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

    ERIC Educational Resources Information Center

    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…

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

    ERIC Educational Resources Information Center

    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…

  15. The Value of Coenzyme Q10 Determination in Mitochondrial Patients

    PubMed Central

    Yubero, Delia; Allen, George; Artuch, Rafael; Montero, Raquel

    2017-01-01

    Coenzyme Q10 (CoQ) is a lipid that is ubiquitously synthesized in tissues and has a key role in mitochondrial oxidative phosphorylation. Its biochemical determination provides insight into the CoQ status of tissues and may detect CoQ deficiency that can result from either an inherited primary deficiency of CoQ metabolism or may be secondary to different genetic and environmental conditions. Rapid identification of CoQ deficiency can also allow potentially beneficial treatment to be initiated as early as possible. CoQ may be measured in different specimens, including plasma, blood mononuclear cells, platelets, urine, muscle, and cultured skin fibroblasts. Blood and urinary CoQ also have good utility for CoQ treatment monitoring. PMID:28338638

  16. Solar photo-degradation of a pharmaceutical wastewater effluent in a semi-industrial autonomous plant.

    PubMed

    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.

  17. The politics of access to expensive drugs: INESSS and the innovative pharmaceutical industry.

    PubMed

    Hughes, David

    2012-05-01

    The innovative pharmaceutical industry employs thousands of people in Quebec and so has the ability to exert strong political pressure; the public statements of Sanofi-Aventis concerning the provincial reimbursement of certain expensive drugs are an example. "Maintaining a dynamic biopharmaceutical industry" is one of four main axes of the drug policy of Quebec's ministry of health. However, this role of government should not take precedence over the efficient and equitable management of health resources. We defend the legitimate and responsible choice of the Institut national d'excellence en santé et en services sociaux du Québec (INESSS) to require an acceptable cost-effectiveness ratio from expensive new drugs.

  18. Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.

    PubMed

    Rockhold, F W; Enas, G G

    1993-03-01

    The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. Data monitoring is a continuous process in industry trials due to the regulatory requirements and the need to more thoroughly evaluate safety of new compounds. As part of this process, interim analyses are employed to make decisions about treatment effects. In some cases, such analyses may require the use of an external data monitoring committee to assist in the data review, analysis and decision making. A number of examples of interim analyses, with and without data monitoring committees, are discussed. Issues surrounding the need for external data monitoring committees and recommendations are presented. In particular the issues of sponsor participation in the data monitoring committee and controls of the decision making process are considered.

  19. Pharmaceuticals occurrence in a WWTP with significant industrial contribution and its input into the river system.

    PubMed

    Collado, N; Rodriguez-Mozaz, S; Gros, M; Rubirola, A; Barceló, D; Comas, J; Rodriguez-Roda, I; Buttiglieri, G

    2014-02-01

    Occurrence and removal of 81 representative Pharmaceutical Active Compounds (PhACs) were assessed in a municipal WWTP located in a highly industrialized area, with partial water reuse after UV tertiary treatment and discharge to a Mediterranean river. Water monitoring was performed in an integrated way at different points in the WWTP and river along three seasons. Consistent differences between therapeutic classes were observed in terms of influent concentration, removal efficiencies and seasonal variation. Conventional (primary and secondary) treatment was unable to completely remove numerous compounds and UV-based tertiary treatment played a complementary role for some of them. Industrial activity influence was highlighted in terms of PhACs presence and seasonal distribution. Even if global WWTP effluent impact on the studied river appeared to be minor, PhACs resulted widespread pollutants in river waters. Contamination can be particularly critical in summer in water scarcity areas, when water flow decreases considerably. Copyright © 2013 Elsevier Ltd. All rights reserved.

  20. Spectroscopic sensors for in-line bioprocess monitoring in research and pharmaceutical industrial application.

    PubMed

    Claßen, Jens; Aupert, Florian; Reardon, Kenneth F; Solle, Dörte; Scheper, Thomas

    2017-01-01

    The use of spectroscopic sensors for bioprocess monitoring is a powerful tool within the process analytical technology (PAT) initiative of the US Food and Drug Administration. Spectroscopic sensors enable the simultaneous real-time bioprocess monitoring of various critical process parameters including biological, chemical, and physical variables during the entire biotechnological production process. This potential can be realized through the combination of spectroscopic measurements (UV/Vis spectroscopy, IR spectroscopy, fluorescence spectroscopy, and Raman spectroscopy) with multivariate data analysis to obtain relevant process information out of an enormous amount of data. This review summarizes the newest results from science and industry after the establishment of the PAT initiative and gives a critical overview of the most common in-line spectroscopic techniques. Examples are provided of the wide range of possible applications in upstream processing and downstream processing of spectroscopic sensors for real-time monitoring to optimize productivity and ensure product quality in the pharmaceutical industry.

  1. Regulating drug information in Europe: a pyrrhic victory for pharmaceutical industry critics?

    PubMed

    Mulinari, Shai

    2013-06-01

    Informed by recent sociological debates on pharmaceuticalisation, this article examines the evolution of the current EU legal proposal on prescription drug information to patients, as well as the surrounding controversies. In 2008 the European Commission proposed the relaxation of the existing rules governing drug information provision to patients by the pharmaceutical industry. Critics of the industry's influence over health policy and markets, including consumer organisations, industry-independent patient organisations and health professionals, rejected the Commission's proposal, claiming that the industry cannot be considered a reliable source of patient information due to inherent financial conflicts of interest. Since these critics were at least partially successful in rallying opinion against the Commission proposal, they functioned as countervailing forces to promotion-driven pharmaceuticalisation. Even so, as a watered-down version of the proposal moved through the European Parliament it was further modified to ultimately resemble the Swedish system that was held up as a high-quality example of industry-based information provision. Yet this article contends that the Swedish system displays evidence of corporate bias. Significantly, basing EU policy on a drug information system not resistant to corporate bias risks creating practices that violate the legally mandated mission of EU drug regulation, which is to 'promote and protect public health'.

  2. In whose interest? Relationships between health consumer groups and the pharmaceutical industry in the UK.

    PubMed

    Jones, Kathryn

    2008-09-01

    This paper explores how health consumer groups in the UK disclose and manage links with pharmaceutical companies in the context of their growing involvement in the policy process. In particular, it examines claims that industry engages with groups in an attempt to capture the groups' policy agenda, thereby increasing industry's political influence. Drawing on theories of disclosure, analysis of group and industry websites revealed a varying level of detail on the nature and extent of relationships. Only 26 per cent of consumer groups known to be in receipt of industry financial or in-kind support openly acknowledged this. Interviews undertaken with representatives from consumer groups, industry and other health-care stakeholders, highlighted a coincidence of aims between the two sectors, an acknowledgement that collaboration was inevitable, and tacit support for policy guidelines to manage conflicts of interest. The paper concludes by arguing that while claims of organisational capture are over-stated, the shallow approach to transparency adopted by the majority of companies and groups strengthens critiques of undue influence. This may ultimately reduce policy makers' willingness to see consumer groups as the legitimate voice of patients, users and carers in the policy process.

  3. [Specificities of patent protection in the pharmaceutical industry: modalities and traits of intellectual property].

    PubMed

    Jannuzzi, Anna Haydée Lanzillotti; Vasconcellos, Alexandre Guimarães; de Souza, Cristina Gomes

    2008-06-01

    Different forms of protection for inventions in the pharmaceutical industry point to strategies for the perpetuation of patent protection. Based on a literature review showing the specificities of patenting in the industry, the article provides a brief history of drug patents in Brazil, a discussion of patentable and non-patentable inventions, and the modalities and traits of patent protection that aim to extend the temporary monopoly granted under the patent. Such strategies include patents targeting polimorphs and optical isomers of drugs and drug combinations and specific clinical preparations, increasingly present in the drug patent claims filed by pharmaceutical companies. The study's objective is to discuss the specificities of drug patent claims in order to help develop expertise in the area and discuss the impact of expanding the scope of patent protection. In conclusion, while the tendency to expand towards more a permissive protective scope could produce opportunities for Brazilian national inventors, it could also be harmful to a policy for access to medicines.

  4. An insight into the emerging role of regional medical advisor in the pharmaceutical industry.

    PubMed

    Gupta, Sandeep Kumar; Nayak, Roopa P

    2013-07-01

    The position of regional medical advisor (RMA) is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving. The RMA is a field based position whose main mission is to foster collaborative relationships with the key opinion leaders (KOLs) and to facilitate the exchange of unbiased scientific information between the medical community and the company. Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry's increased focus on global operations including emerging markets. Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. The major objective of the RMA is to develop the professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact. The RMA can facilitate investigator-initiated clinical research proposals from approval until completion, presentation, and publication. It is possible for a RMA to have valuable access to KOLs through his expertise in the clinical research. The RMA can assist in the development, review, and follow-up of the clinical studies initiated within the relevant therapeutic area at the regional/local level. The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines.

  5. An insight into the emerging role of regional medical advisor in the pharmaceutical industry

    PubMed Central

    Gupta, Sandeep Kumar; Nayak, Roopa P.

    2013-01-01

    The position of regional medical advisor (RMA) is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving. The RMA is a field based position whose main mission is to foster collaborative relationships with the key opinion leaders (KOLs) and to facilitate the exchange of unbiased scientific information between the medical community and the company. Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry's increased focus on global operations including emerging markets. Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. The major objective of the RMA is to develop the professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact. The RMA can facilitate investigator-initiated clinical research proposals from approval until completion, presentation, and publication. It is possible for a RMA to have valuable access to KOLs through his expertise in the clinical research. The RMA can assist in the development, review, and follow-up of the clinical studies initiated within the relevant therapeutic area at the regional/local level. The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines. PMID:24010061

  6. Coenzyme Q10 in the diet--daily intake and relative bioavailability.

    PubMed

    Weber, C; Bysted, A; Hølmer, G

    1997-01-01

    The coenzyme Q10 content of the average Danish diet was estimated from consumption data and from analysis of food items to be 3-5 mg coenzyme Q10 per day, primarily derived (64% of the total) from meat and poultry. To investigate if coenzyme Q10 was absorbed to any significant degree from a food item, a randomized cross-over study with single doses of coenzyme Q10 (30 mg/person), administered either as a meal or as capsules, was carried out in healthy subjects. The serum coenzyme Q10 concentration increased significantly, and the maximum concentrations did not differ significantly for the two forms of administration. The study indicates that coenzyme Q10 is present in food items and absorbed to a significant degree. Thus, dietary coenzyme Q10 may contribute to the plasma coenzyme Q10 concentration.

  7. Scalable Technology for the Extraction of Pharmaceutics (STEP): the transition from academic knowhow to industrial reality.

    PubMed

    Sutherland, Ian; Ignatova, Svetlana; Hewitson, Peter; Janaway, Lee; Wood, Philip; Edwards, Neil; Harris, Guy; Guzlek, Hacer; Keay, David; Freebairn, Keith; Johns, David; Douillet, Nathalie; Thickitt, Chris; Vilminot, Elsa; Mathews, Ben

    2011-09-09

    This paper addresses the technological readiness of counter-current chromatography (CCC) instruments to become platform technology for the pharmaceutical industry. It charts the development of the prototype technology since its inception in 1966, through conceptual improvements in the 1980s that led to higher speed separations in hours as opposed to days. It then describes the engineering improvements that have led to the development of high performance counter-current chromatography with the potential for scale-up to process scale for manufacturing products in industry with separation times in minutes rather than hours. A new UK Technology Strategy Board high value manufacturing £1.5 m research programme to take CCC through to technology readiness level 8 (i.e. as platform technology for continuous 24 × 7 operation by industry) is introduced. Four case studies are given as examples of successes from its expanding applications portfolio, which is mainly confidential. Finally, the hurdles for the uptake of new technology by industry are highlighted and the following potential solutions given: rapid method development, automation, continuous processing and instrument reliability and robustness. The future challenge for the CCC community will be to address these development needs urgently if CCC is to become the platform technology it deserves to be.

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

    PubMed

    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.

  9. A survey on IVIVC/IVIVR development in the pharmaceutical industry - Past experience and current perspectives.

    PubMed

    Nguyen, M A; Flanagan, T; Brewster, M; Kesisoglou, F; Beato, S; Biewenga, J; Crison, J; Holm, R; Li, R; Mannaert, E; McAllister, M; Mueller-Zsigmondy, M; Muenster, U; Ojala, K; Page, S; Parr, A; Rossenu, S; Timmins, P; Van Peer, A; Vermeulen, A; Langguth, P

    2017-05-01

    The present work aimed to describe the current status of IVIVC/IVIVR development in the pharmaceutical industry, focusing on the use and perception of specific approaches as well as successful and failed case studies. Two questionnaires have been distributed to 13 EFPIA partners of the Oral Biopharmaceutics Tools Initiative and to the Pharmacokinetics Working Party of the European Medicines Agency in order to capture the perspectives and experiences of industry scientists and agency members, respectively. Responses from ten companies and three European Agencies were received between May 21st 2014 and January 19th 2016. The majority of the companies acknowledged the importance of IVIVC/IVIVR throughout the drug development stages and a well-balanced rate of return on investment. However, the IVIVC/IVIVR approach seemed to be underutilized in regulatory submissions. Four of the ten companies stated to have an internal guidance related to IVIVC/IVIVR modelling, whereas three felt that an overall strategy is not necessary. Successful models mainly served to support formulation development and to provide a better mechanistic understanding. There was not yet much experience with safe-space IVIVRs as well as the use of physiologically based modelling in the field of IVIVC. At the same time, the responses from both industry and agencies indicated that there might be a need for a regulatory framework to guide the application of these novel approaches. The relevance of IVIVC/IVIVR for oral IR drug products was recognized by most of the companies. For IR formulations, relationships other than Level A correlation were more common outcomes among the provided case studies, such as multiple Level C correlation or safe-space IVIVR, which could be successfully used for requesting regulatory flexibility. Compared to the responses from industry scientists, there was a trend towards a higher appreciation of the BCS among the regulators, but a less positive attitude towards the utility

  10. Muscle coenzyme Q10 deficiencies in ataxia with oculomotor apraxia 1.

    PubMed

    Le Ber, I; Dubourg, O; Benoist, J-F; Jardel, C; Mochel, F; Koenig, M; Brice, A; Lombès, A; Dürr, A

    2007-01-23

    APTX gene mutations responsible for ataxia-oculomotor apraxia 1 (AOA1) were identified in a family previously reported with ataxia and coenzyme Q10 (CoQ10) deficiency. We measured muscle CoQ10 levels in six patients with AOA1 and found decreased levels in five. Patients homozygous for the W279X mutation had lower values (p = 0.003). A therapeutic trial of CoQ10 may be warranted in patients with AOA1.

  11. Relative bioavailability and antioxidant potential of two coenzyme q10 preparations.

    PubMed

    Kurowska, Elzbieta M; Dresser, George; Deutsch, Luisa; Bassoo, Errol; Freeman, David J

    2003-01-01

    Coenzyme Q10 (CoQ10) is synthesized by the human body and found in certain foods. Daily supplementation of CoQ10 could protect against heart disease but the bioavailability of CoQ10 supplements depends on the formulation taken. We compared the bioavailability and antioxidant properties of two commercial CoQ10 formulations, a commercial grade CoQ10 powder (commercial grade CoQ) and a new BT-CoQ10 BIO-TRANSFORMED (BT-CoQ10) obtained by fermentation of a soy-based, CoQ10-rich media with baker's yeast. Eleven healthy individuals participated in a randomized two-way crossover trial, with a 3-week washout period. Capsules containing 300 mg of either BT-CoQ10 or commercial grade CoQ10 were given daily for 1 week and multiple blood samples were taken for CoQ10, glutathione and glutathione peroxidase (GPx) determination. In 3 subjects, baseline plasma CoQ10 levels were lower prior to BT than prior to commercial grade CoQ treatment. In the remaining participants, ingestion of BT vs. commercial grade CoQ significantly increased maximum plasma CoQ10 concentration (+126%, p = 0.04) and tended to increase CoQ10 area under the curve from 0 to 24 h (+160%, p = 0.07). One week of treatment with each formulation increased plasma CoQ10 but did not alter plasma glutathione or GPx activity. The enhanced bioavailability of the BT product might be due to its predominantly reduced, hydrophilic membrane-complex form. Copyright 2003 S. Karger AG, Basel

  12. Smoking habits and coenzyme Q10 status in healthy European adults

    PubMed Central

    Fischer, Alexandra; Onur, Simone; Paulussen, Michael; Menke, Thomas; Döring, Frank

    2016-01-01

    Introduction Coenzyme Q10 (CoQ10) is a lipophilic endogenously synthesised antioxidant that is present in nearly all human tissues and plays an important role in mitochondrial energy production. It has been postulated that smoking has a consumptive effect on CoQ10. Material and methods To further define the relation between smoking and the serum CoQ10 status, 276 healthy volunteers aged 19 to 62 years were grouped into non-smokers (n = 113; 77 male, 36 female) and smokers (n = 163; 102 male, 61 female). Serum lipid profile was analysed by standard clinical chemistry. Coenzyme Q10 concentration and redox status were analysed by high-pressure liquid chromatography with electrochemical detection. Results Male smokers showed higher serum CoQ10 levels than female smokers. This sex-related difference was accounted for when CoQ10 was related to low-density lipoprotein (LDL) cholesterol as the main carrier of CoQ10 in the circulation. Neither LDL-adjusted CoQ10 concentration nor redox status significantly differed when smokers and non-smokers were compared. Regarding the smoking history, the number of cigarettes consumed per day did not significantly affect the CoQ10 status. Interestingly, with increasing time of smoking habit we observed increasing levels of LDL-adjusted serum CoQ10 concentration (Spearman's p < 0.002) and of the reduced form of CoQ10 (Spearman's p < 0.0001). Conclusions As an adaptive response to oxidative stress in long-term smokers an increased demand for antioxidant capacity may be covered by increasing levels of LDL-adjusted CoQ10 serum concentrations and by a concomitantly increased availability of the reduced, active form of CoQ10, possibly by induction of enzymes that are involved in converting CoQ10ox to CoQ10red. PMID:27478450

  13. [From the design of use study to the assessment of the benefit: with or without pharmaceutical industry?].

    PubMed

    Porzsolt, Franz

    2010-12-01

    The financing of clinical studies by the pharmaceutical industry is a controversial topic both internationally and in here in Germany. The well-known unacceptable shortcomings require no further confirmation. It is, however, indisputable that the pharmaceutical industry and medical science are co-dependent. Neither the marketing of industrial products nor the research and education of clinical scientists could function without this cooperation. Therefore, all partners need suggestions concerning goal orientation and consensus. The aim of this discussion is to formulate just such suggestions. To structure this discussion, we have raised the following questions: Must we always be suspicious of the results of studies financed by the pharmaceutical industry? We have to keep in mind that in Germany all clinical trials leading to approval of a drug were supported by the industry. What, exactly, do we want to achieve with our explicit and often justified criticism of these studies? What should be done to achieve a higher validity of the published data if we avoid answering the decisive question of whether we accept the challenge of continuing to let research and teaching be financed by the pharmaceutical industry or reject this kind of cooperation and support altogether.

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

    PubMed

    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

  15. Nano-encapsulation of coenzyme Q10 using octenyl succinic anhydride modified starch

    USDA-ARS?s Scientific Manuscript database

    Octenyl succinic anhydride modified starch (OSA-ST) was used to encapsulate Coenzyme Q10 (CoQ10). CoQ10 was dissolved in rice bran oil (RBO), and incorporated into an aqueous OSA-ST solution. High pressure homogenization (HPH) of the mixture was conducted at 170 MPa for 5-6 cycles. The resulting ...

  16. Performance and data interpretation of the in vivo comet assay in pharmaceutical industry: EFPIA survey results.

    PubMed

    van der Leede, Bas-Jan; Doherty, Ann; Guérard, Melanie; Howe, Jonathan; O'Donovan, Mike; Plappert-Helbig, Ulla; Thybaud, Véronique

    2014-12-01

    In genotoxicity testing of pharmaceuticals the rodent alkaline comet assay is being increasingly used as a second in vivo assay in addition to the in vivo micronucleus assay to mitigate in vitro positive results as recommended by the ICH S2(R1) guideline. This paper summarizes a survey suggested by the Safety Working Party of European Medicines Agency (EMA), and conducted by the European Federation of Pharmaceutical Industries and Associations (EFPIA) to investigate the experience among European pharmaceutical companies by conducting the in vivo comet assay for regulatory purpose. A special focus was given on the typology of the obtained results and to identify potential difficulties encountered with the interpretation of study data. The participating companies reported a total of 147 studies (conducted in-house or outsourced) and shared the conclusion on the comet assay response for 136 studies. Most of the studies were negative (118/136). Only about 10% (14/136 studies) of the comet assays showed a positive response. None of the positive comet assay results were clearly associated with organ toxicity indicating that the positive responses are not due to cytotoxic effects of the compound in the tissue examined. The number of comet assays with an equivocal or inconclusive response was rare, respectively <1% (1/147 studies) and 2% (3/147 studies). In case additional information (e.g. repeat assay, organ toxicity, metabolism, tissue exposure) would have been available for evaluation, a final conclusion could most probably have been drawn for most or all of these studies. All (46) negative in vivo comet assays submitted alongside with a negative in vivo micronucleus assay were accepted by the regulatory authorities to mitigate a positive in vitro mammalian cell assay following the current ICH S2 guidance. The survey results demonstrate the robustness of the comet assay and the regulatory acceptance of the current ICH S2 guidance.

  17. Assessment of the Embryonic Stem Cell Test and application and use in the pharmaceutical industry.

    PubMed

    Paquette, Jennifer A; Kumpf, Steven W; Streck, Randal D; Thomson, Jason J; Chapin, Robert E; Stedman, Donald B

    2008-04-01

    The European Centre for the Validation of Alternative Methods (ECVAM) designed the Embryonic Stem Cell Test (EST) as a tool for classifying developmentally toxic compounds. An in vitro tool to assess developmental toxicity would be of great value to the pharmaceutical industry to help with toxicity-associated attrition. ECVAM's EST protocol was used, but employing a different mouse embryonic stem cell (ESC) line and an alternative differentiation medium. A subset of the compounds used to validate the EST assay along with a number of in-house pharmaceutical compounds plus marketed pharmaceutical compounds were used to assess the EST performance with receptor-mediated compounds. Our results with ECVAM compounds mirrored ECVAM's. Compounds that were developmentally toxic in vivo were classified by the EST as moderate risk. Overall, the accuracy was 75% with the current set of data and the predictivity of low-, moderate-, and high-risk compounds was 90, 71, and 60% while the precision was 59, 86, and 100%, respectively. Interestingly, a number of the non-developmentally toxic compounds had values for the 3T3 IC(50) values, which were lower than the ESC IC(50) and ID(50), a situation not taken into account by ECVAM when designing the EST algorithm. The assay as currently constructed has a significant false-positive rate (approximately 40%), but a very low false-negative rate (approximately 7%). Additional moderate- and high-risk compounds need to be assessed to increase confidence, accuracy, and understanding in the EST's predictivity. (c) 2008 Wiley-Liss, Inc.

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

    PubMed

    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.

  19. Effect of rosuvastatin on plasma coenzyme Q10 in HIV-infected individuals on antiretroviral therapy

    PubMed Central

    Morrison, Justin T.; Longenecker, Chris T.; Mittelsteadt, Alison; Jiang, Ying; Debanne, Sara M.; McComsey, Grace A.

    2016-01-01

    BACKGROUND Coenzyme Q10 (CoQ10) deficiency has been associated with statin-induced myopathy, and supplementation with CoQ10 may reduce inflammation markers. The effects of statins on CoQ10 and its anti-inflammatory properties have not been investigated in HIV-positive patients. OBJECTIVE The objectives of this study were to examine the effect of rosuvastatin on CoQ10 and CoQ10/LDL ratio over 24 weeks SATURN-HIV trial, explore the associations between CoQ10 levels and markers of vascular disease, inflammation, and immune activation, and assess whether changes in CoQ10 affected the anti-inflammatory effects of statin therapy or were associated with myalgia symptoms. METHODS This was a secondary analysis of the SATURN-HIV trial, a 96-week randomized clinical trial of 10mg daily rosuvastatin vs. placebo in HIV-infected patients on antiretroviral therapy. We assessed the statin treatment effect on CoQ10 levels and CoQ10/LDL ratios and whether changes in these markers were related to myalgias. Relationships between CoQ10, subclinical vascular disease, and biomarkers of inflammation and immune activation were explored using Spearman correlations and multivariable regression models. RESULTS Overall, 147 patients were included. Median age was 46 years; 78% were male, 68% African American. At baseline, CoQ10 levels and CoQ10/LDL ratio were modestly correlated with markers of HIV disease, immune activation, and carotid distensibility. After 24 weeks of statin therapy, CoQ10 levels decreased (p=0.002 for between group difference) and CoQ10/LDL ratio increased (p=0.036). In the statin treatment arm, we did not find evidence of a relationship between changes in CoQ10 or CoQ10/LDL ration and changes in markers of inflammation or immune activation. There was a borderline statistically significant association between changes in CoQ10 and myalgia symptoms [OR 4.0 per 0.1mg/L decrease in CoQ10, p=0.07]. CONCLUSION Twenty-four weeks of 10mg daily rosuvastatin decreases CoQ10

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

    PubMed Central

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

    2016-01-01

    Objectives To explore European-based pharmaceutical industry professionals’ beliefs about patient and public involvement (PPI) in medicines research and development (R&D). Setting Pharmaceutical companies in the UK, Poland and Spain. Participants 21 pharmaceutical industry professionals, four based in the UK, five with pan-European roles, four based in Spain and eight based in Poland. Method 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. Results 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. Conclusions 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. PMID:26743701

  1. Marketed Marine Natural Products in the Pharmaceutical and Cosmeceutical Industries: Tips for Success

    PubMed Central

    Martins, Ana; Vieira, Helena; Gaspar, Helena; Santos, Susana

    2014-01-01

    The marine environment harbors a number of macro and micro organisms that have developed unique metabolic abilities to ensure their survival in diverse and hostile habitats, resulting in the biosynthesis of an array of secondary metabolites with specific activities. Several of these metabolites are high-value commercial products for the pharmaceutical and cosmeceutical industries. The aim of this review is to outline the paths of marine natural products discovery and development, with a special focus on the compounds that successfully reached the market and particularly looking at the approaches tackled by the pharmaceutical and cosmetic companies that succeeded in marketing those products. The main challenges faced during marine bioactives discovery and development programs were analyzed and grouped in three categories: biodiversity (accessibility to marine resources and efficient screening), supply and technical (sustainable production of the bioactives and knowledge of the mechanism of action) and market (processes, costs, partnerships and marketing). Tips to surpass these challenges are given in order to improve the market entry success rates of highly promising marine bioactives in the current pipelines, highlighting what can be learned from the successful and unsuccessful stories that can be applied to novel and/or ongoing marine natural products discovery and development programs. PMID:24549205

  2. [The pharmaceutical industry and the sustainability of healthcare systems in developed countries and in Latin America].

    PubMed

    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.

  3. Keynote review: Is declining innovation in the pharmaceutical industry a myth?

    PubMed

    Schmid, Esther F; Smith, Dennis A

    2005-08-01

    Increasing the rate of innovation is a requirement to achieve much-needed advances in patient care, as well as to secure the future of the pharmaceutical industry. Currently, there is a perception in the external environment that pharmaceutical R&D is no longer innovative, fails to bring new drugs to market or, at best, produces a rising number of 'me-too' drugs with no advantage over existing treatments. In addition, the cost to discover and develop new medicines (i.e. cost per launch) has risen dramatically in recent years. The quoted development cost per medicine is a reality, and is not disputed here. However, data are provided that demonstrate that with regard to innovation rates, the current perception is wrong - although there have been, and continue to be, fluctuations in drug launches, there has been a steady increase in the number of new chemical entities launched, both in absolute numbers of FDA-approved medicines and in the proportion of priority reviews.

  4. Key issues in the pharmaceutical industry: consequences on R&D.

    PubMed

    Malik, Nafees N

    2009-01-01

    Drug discovery is hard, and is becoming progressively harder, with the passage of time! No other field has to handle such an interplay of scientific, fiscal and political factors. The rewards are, nonetheless, worth it: people now live healthier and longer lives than at any point of time in the past. Times are, however, hard for pharmaceutical companies: research and development (R&D) costs are spiralling out of control. New drug approvals, on the other hand, have hit a record low; and the situation is expected to worsen, now that the FDA seems to be exhibiting stricter drug approval standards. Other issues also exacerbate circumstances: huge numbers of blockbuster medicines, which drugmakers rely on to generate their incomes, are coming off patent, and generic competition is intensifying. Both public and investor confidence in the industry have fallen drastically owing to rising drug prices, product safety concerns and late-stage clinical trial failures. This article discusses the key issues that pharmaceutical companies face and in particular the implications they have for the R&D process. I finish by suggesting how drugmakers should change their R&D strategies to succeed.

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

    PubMed

    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.

  6. The role of the pharmaceutical industry in meeting the public health threat of antibacterial resistance.

    PubMed

    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.

  7. Curbing misconduct in the pharmaceutical industry: insights from behavioral ethics and the behavioral approach to law.

    PubMed

    Feldman, Yuval; Gauthier, Rebecca; Schuler, Troy

    2013-01-01

    Two insights of psychology on which we would like to draw are that people react to law in more complex ways than rational-choice models assume and that good people sometimes do bad things. With that starting point, this article provides a behavioral perspective on some of the factors that policymakers seeking to reduce the level of misconduct in the pharmaceutical industry should consider. Effective regulation and enforcement need to address the following questions: Who are the regulation's targeted actors - researchers or executives? Are the regulations directed toward research or marketing activities? Is the misconduct a product of explicit rational choice or implicit processes of which the actor is unaware? Is it reasonable to address all types of misconduct using the same approach? Certain misconduct - particularly by researchers - is due to automatic, intuitive, and unconscious decisions and needs to be addressed through different means than those used to address misconduct due to controlled, deliberate decisions. This article therefore recommends using different sorts of regulation depending on the context. It suggests more tailored enforcement mechanisms that will be sensitive to the pharmaceutical researchers' unique work motivations and to their awareness or lack of awareness of their own misconduct.

  8. Marketed marine natural products in the pharmaceutical and cosmeceutical industries: tips for success.

    PubMed

    Martins, Ana; Vieira, Helena; Gaspar, Helena; Santos, Susana

    2014-02-17

    The marine environment harbors a number of macro and micro organisms that have developed unique metabolic abilities to ensure their survival in diverse and hostile habitats, resulting in the biosynthesis of an array of secondary metabolites with specific activities. Several of these metabolites are high-value commercial products for the pharmaceutical and cosmeceutical industries. The aim of this review is to outline the paths of marine natural products discovery and development, with a special focus on the compounds that successfully reached the market and particularly looking at the approaches tackled by the pharmaceutical and cosmetic companies that succeeded in marketing those products. The main challenges faced during marine bioactives discovery and development programs were analyzed and grouped in three categories: biodiversity (accessibility to marine resources and efficient screening), supply and technical (sustainable production of the bioactives and knowledge of the mechanism of action) and market (processes, costs, partnerships and marketing). Tips to surpass these challenges are given in order to improve the market entry success rates of highly promising marine bioactives in the current pipelines, highlighting what can be learned from the successful and unsuccessful stories that can be applied to novel and/or ongoing marine natural products discovery and development programs.

  9. The effects of lifelong ubiquinone Q10 supplementation on the Q9 and Q10 tissue concentrations and life span of male rats and mice.

    PubMed

    Lönnrot, K; Holm, P; Lagerstedt, A; Huhtala, H; Alho, H

    1998-04-01

    The effect of lifelong oral supplementation with ubiquinone Q10 (10 mg/kg/day) was examined in Sprague-Dawley rats and C57/B17 mice. There were no significant differences in survival or life-span found in either rats or mice. Histopathologic examination of different rat tissues showed no differences between the groups. In Q10 supplemented rats, plasma and liver Q10 levels were 2.6 to 8.4 times higher at all age points than in control rats. Interestingly, in supplemented rats the Q9 levels also were significantly higher (p<0.05) in plasma and liver at ages 18 and 24 months. Neither Q9 nor Q10 levels were affected by supplementation in kidney, heart, or brain tissues. In spite of the significant changes in plasma and liver ubiquinone concentrations, lifelong Q10 supplementation did not prolong or shorten the lifespan of either rats or mice.

  10. Biodegradability of pharmaceutical industrial wastewater and formation of recalcitrant organic compounds during aerobic biological treatment.

    PubMed

    Mascolo, G; Balest, L; Cassano, D; Laera, G; Lopez, A; Pollice, A; Salerno, C

    2010-04-01

    The biodegradability of different wastewater samples originated from the industrial production of three pharmaceuticals (naproxen, acyclovir, and nalidixic acid) was performed through the standard Zahn-Wellens test. Moreover, the wastewater composition before and during the test was evaluated in terms of parent compounds and main metabolites by LC/MS, and the biodegradability of the parent compounds was also assessed by performing extra Zahn-Wellens tests on synthetic solutions. The results, besides showing the relatively good biodegradability of acyclovir and naproxen, evidenced the masking role of the organic matrices, especially in the case of nalidixic acid. The latter compound showed to be recalcitrant and persistent, despite the apparently good performance of the Zahn-Wellens test. Deeper evaluation evidenced that the biodegradation of high concentrations of organic solvents and other biodegradable compound tended to "hide" the lack of removal of the target compound. Copyright 2009 Elsevier Ltd. All rights reserved.

  11. [Incentives and disincentives for research and development of new drugs by the pharmaceutical industry].

    PubMed

    Curcio, Pasqualina Curcio

    2008-10-01

    The authors present a model with factors that influence research and development decisions by the pharmaceutical industry: risk of disease transmission and possibility of control; case-fatality and the presence of cure or treatments; income; number of persons who demand the medicine; and opportunity costs for the company. Companies tend to invest in markets with inelastic demand (highly contagious diseases with no possibility of controlling transmission and/or very lethal diseases without treatment) and/or where there is a large population or high per capita income. Companies tend not to invest in markets where marginal costs exceed marginal income, particularly when costs increase permanently as a consequence of rising opportunity costs generated by foregoing profit in other markets. In such cases, policies to subsidize R&D are not effective, and policies must be orientated towards strengthening basic and applied research by public institutions.

  12. Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries.

    PubMed

    Tomlinson, Lindsay; Boone, Laura I; Ramaiah, Lila; Penraat, Kelley A; von Beust, Barbara R; Ameri, Mehrdad; Poitout-Belissent, Florence M; Weingand, Kurt; Workman, Heather C; Aulbach, Adam D; Meyer, Dennis J; Brown, Diane E; MacNeill, Amy L; Bolliger, Anne Provencher; Bounous, Denise I

    2013-09-01

    The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines) and published recommendations for best practices in veterinary toxicologic clinical pathology, particularly in the pharmaceutical and biotechnology industries, and to utilize the combined experience of ASVCP RAC to provide updated recommendations. Discussion points include (1) instrumentation, validation, and sample collection, (2) routine laboratory variables, (3) cytologic laboratory variables, (4) data interpretation and reporting (including peer review, reference intervals and statistics), and (5) roles and responsibilities of clinical pathologists and laboratory personnel. Revision and improvement of current practices should be in alignment with evolving regulatory guidance documents, new technology, and expanding understanding and utility of clinical pathology. These recommendations provide a contemporary guide for the refinement of veterinary toxicologic clinical pathology best practices.

  13. In search of sustainability: process R&D in light of current pharmaceutical industry challenges.

    PubMed

    Federsel, Hans-Jürgen

    2006-11-01

    Is there a need for a paradigm shift in the pharmaceutical industry? Many researchers think so and take as examples the eroding corporate reputation, a regulatory environment that is harsher than ever, and the request for cheaper drugs from patient organizations and authorities. Process R&D, which interfaces medicinal chemistry and production, has taken on this challenge by increasing the delivery focus early on to ensure timely availability of desired compounds. The quest for lower costs of goods has forced the design of best synthetic routes that, given the molecular complexity, often lead to catalytic methodologies. Applying these methodologies will enable not only the cost element, but also the increasingly important aspects of environmental friendliness, and atom and stage efficiency, to be addressed.

  14. Impact of the World Trade Organization TRIPS agreement on the pharmaceutical industry in Thailand.

    PubMed Central

    Supakankunti, S.; Janjaroen, W. S.; Tangphao, O.; Ratanawijitrasin, S.; Kraipornsak, P.; Pradithavanij, P.

    2001-01-01

    The 1994 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) established minimum universal standards in all areas of intellectual property. It is intended to implement these standards globally through a WTO enforcement mechanism. The present article proposes a strategy for alleviating the potentially negative impact of TRIPS in Thailand in relation to the following: purchasers; prescribers and dispensers; producers; products; price control; patent-to-third-party; parallel imports; power of the customer; patentable new drugs; personnel; and prevention policies. The following TRIPS provisions are pertinent to the pharmaceutical industry in Thailand: the limited term of product and process patents; the conditions of protection; and the broad scope for compulsory licensing and enforcement procedures in the national patent system. PMID:11417042

  15. Crystalline coats or hollow crystals as tools for product design in pharmaceutical industry

    NASA Astrophysics Data System (ADS)

    Ulrich, J.; Schuster, A.; Stelzer, T.

    2013-01-01

    The coating of pharmaceutical compounds is a field of high interest. As most of the coating materials form an amorphous layer around the material, the studies on crystalline coatings are rare. In this work the progress in this domain should be summarized and innovative results concerning crystalline hollow needles as coating material are presented. Since the first reports on needles formed via a solvent-mediated phase transition from solvates to hydrates, the field could be widened to hydrate-to-anhydrate and anhydrate-to-hydrate transformations. Novel investigations on hollow theophylline monohydrate and carbamazepine dihydrate needles are presented. It is shown that the inclusion of substances into the hollow needle crystals is feasible by simple means, which enable an application in industry as coating for sensitive materials.

  16. [Emission characteristics and hazard assessment analysis of volatile organic compounds from chemical synthesis pharmaceutical industry].

    PubMed

    Li, Yan; Wang, Zhe-Ming; Song, Shuang; Xu, Zhi-Rong; Xu, Ming-Zhu; Xu, Wei-Li

    2014-10-01

    In this study, volatile organic compounds (VOCs) released from chemical synthesis pharmaceutical industry in Taizhou, Zhejiang province were analyzed quantitatively and qualitatively. The total volatile organic compounds (TVOCs) was in the range of 14.9-308.6 mg · m(-3). Evaluation models of ozone formation potentials (OFP) and health risk assessment were adopted to preliminarily assess the environmental impact and health risk of VOCs. The results showed that the values of OFP of VOCs were in the range of 3.1-315.1 mg · m(-3), based on the maximum incremental reactivity, the main principal contribution was toluene, tetrahydrofuran (THF), acetic ether etc. The non-carcinogenic risk and the carcinogen risk fell in the ranges of 9.48 x 10(-7)-4.98 x 10(-4) a(-1) and 3.17 x 10(-5)- 6.33 x 10(-3). The principal contribution of VOCs was benzene, formaldehyde and methylene chloride.

  17. The Impact of Chemical Probes in Drug Discovery: A Pharmaceutical Industry Perspective.

    PubMed

    Garbaccio, Robert M; Parmee, Emma R

    2016-01-21

    Chemical probes represent an important component of both academic and pharmaceutical drug discovery research. As a complement to prior reviews that have defined this scientific field, we aim to provide an industry perspective on the value of having high-quality chemical probes throughout the course of preclinical research. By studying examples from the internal Merck pipeline, we recognize that these probes require significant collaborative investment to realize their potential impact in clarifying the tractability and translation of a given therapeutic target. This perspective concludes with recommendations for chemical probe discovery aimed toward maximizing their potential to identify targets that result in the successful delivery of novel therapeutics. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

    PubMed Central

    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

  19. Medications development for substance-use disorders: contextual influences (dis)incentivizing pharmaceutical-industry positioning.

    PubMed

    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.

  20. Pharmaceutical industry gifts to physicians: patient beliefs and trust in physicians and the health care system.

    PubMed

    Grande, David; Shea, Judy A; Armstrong, Katrina

    2012-03-01

    Pharmaceutical industry gifts to physicians are common and influence physician behavior. Little is known about patient beliefs about the prevalence of these gifts and how these beliefs may influence trust in physicians and the health care system. To measure patient perceptions about the prevalence of industry gifts and their relationship to trust in doctors and the health care system. Cross sectional random digit dial telephone survey. African-American and White adults in 40 large metropolitan areas. Respondents' beliefs about whether their physician and physicians in general receive industry gifts, physician trust, and health care system distrust. Overall, 55% of respondents believe their physician receives gifts, and 34% believe almost all doctors receive gifts. Respondents of higher socioeconomic status (income, education) and younger age were more likely to believe their physician receives gifts. In multivariate analyses, those that believe their personal physician receives gifts were more likely to report low physician trust (OR 2.26, 95% CI 1.56-3.30) and high health care system distrust (OR 2.03, 95% CI 1.49-2.77). Similarly, those that believe almost all doctors accept gifts were more likely to report low physician trust (OR 1.69, 95% CI 1.25-2.29) and high health care system distrust (OR 2.57, 95% CI 1.82-3.62). Patients perceive physician-industry gift relationships as common. Patients that believe gift relationships exist report lower levels of physician trust and higher rates of health care system distrust. Greater efforts to limit industry-physician gifts could have positive effects beyond reducing influences on physician behavior.

  1. Total coenzyme Q10 concentrations in Asian men following multiple oral 50-mg doses administered as coenzyme Q10 sustained release tablets or regular tablets.

    PubMed

    Lu, Wan-Liang; Zhang, Qiang; Lee, How-Sung; Zhou, Tian-Yan; Sun, Hua-Dong; Zhang, Da-Wei; Zheng, Li; Lee, Michael; Wong, Sai-Ming

    2003-01-01

    Coenzyme Q(10) (CoQ(10)), a highly lipophilic compound present in the inner mitochondrial membrane, is essential for production of cellular energy in the form of ATP. CoQ(10) is used as a dietary supplement and for treatment of various cardiovascular disorders. Our goal was to compare the CoQ(10) levels in Asians following multiple oral doses administered as sustained release or regular tablets. Twenty healthy male volunteers (19-23 years old) were divided into two equal groups. Each subject in Group I received 50 mg oral doses of coenzyme Q(10) as sustained release tablets once a day for fifteen days, while subject in Group II received 50 mg doses of coenzyme Q(10) regular tablets. The CoQ(10) levels were measured by HPLC-UV (reverse phase ODS column, 10 microm, 250 x 4.6 mm; oven temperature 30 degrees C). Mobile phase was constituted by methanol-ethanol 9 : 1 v/v. Flow rate was 1.5 ml/min and UV detection was carried out at 275 nm. Coenzyme Q(9) was used as an internal standard. CoQ(10) baseline in the morning was 0.88+/-0.48 mg/l. Following 1 week 50 mg/d dosing of CoQ(10), plasma CoQ(10) concentrations increased to 1.85+/-1.03 mg/l for sustained release tablets and up to 1.37+/-0.74mg/l for regular tablets. The net increment proportion in AUC for sustained release and regular tablets were 148.26+/-176.56%, 102.57+/-130.00%, respectively. Both preparations significantly increased the systemic exposure when compared to endogenous baseline.

  2. Contact between doctors and the pharmaceutical industry, their perceptions, and the effects on prescribing habits.

    PubMed

    Lieb, Klaus; Scheurich, Armin

    2014-01-01

    The prescribing behaviour of doctors is influenced by the pharmaceutical industry. This study investigated the extent to which contacts with pharmaceutical sales representatives (PSR) and the perception of these contacts influence prescribing habits. An online questionnaire regarding contact with PSRs and perceptions of this contact was sent to 1,388 doctors, 11.5% (n = 160) of whom completed the survey. Individual prescribing data over a year (number of prescriptions, expenditure, and daily doses) for all on-patent branded, off-patent branded, and generic drugs were obtained from the Bavarian Association of Statutory Health Insurance Physicians. 84% of the doctors saw PSR at least once a week, and 14% daily. 69% accepted drug samples, 39% accepted stationery and 37% took part in sponsored continuing medical education (CME) frequently. 5 physicians (3%) accepted no benefits at all. 43% of doctors believed that they received adequate and accurate information from PSRs frequently or always and 42% believed that their prescribing habits were influenced by PSR visits occasionally or frequently. Practices that saw PSRs frequently had significantly higher total prescriptions and total daily doses (but not expenditure) than practices that were less frequently visited. Doctors who believed that they received accurate information from PSRs showed higher expenditures on off-patent branded drugs (thus available as generics) and a lower proportion of generics. The eschewal of sponsored CME was associated with a lower proportion of on patent-branded drug prescriptions, lower expenditure on off-patent branded drug prescriptions and a higher proportion of generics. Acceptance of office stationery was associated with higher daily doses. Avoidance of industry-sponsored CME is associated with more rational prescribing habits. Furthermore, gift acceptance and the belief that one is receiving adequate information from a PSR are associated with changed prescribing habits. Further

  3. The pharmaceutical industry and the German National Socialist Regime: I.G. Farben and pharmacological research.

    PubMed

    López-Muñoz, F; García-García, P; Alamo, C

    2009-02-01

    Before the National Socialist party came to power, the German pharmaceutical industry constituted an international reference as far as the development of new medicines was concerned, having been responsible for synthetic analgesics (phenacetin, phenazones, acetylsalicylic acid), arsphenamine, barbiturates and sulfonamides. The year 1925 saw the founding of I.G. Farben (Interessen-Gemeinschaft Farbenindustrie AG), a conglomerate of companies that would monopolize the country's chemical production and come to own all its major pharmaceutical industries. During the World War II, I.G. Farben participated in numerous operations associated with the criminal activities of the Nazi executive, including the use of slave labour in plants built close to concentration camps, such as that at Auschwitz. With regard to medical and pharmacological research projects, I.G. Farben became involved in experimental programmes using patients from the Nazi regime's euthanasia programmes and healthy subjects recruited without their consent from concentration camps, on whom various pharmacological substances were tested, including sulfamide and arsenical derivatives and other preparations whose composition is not precisely known (B-1012, B-1034, 3382 or Rutenol, 3582 or Acridine), generally in relation to the treatment of infectious diseases, such as typhus, erysipelas, scarlet fever or paratyphoid diarrhoea. Furthermore, I.G. Farben played a decisive role in the German army's chemical warfare programme, contributing to the development of the first two neurotoxic substances, later known as 'nerve agents', tabun and sarin. Some of these activities came to light as a result of the one the famous Nuremberg Trials in 1947, which saw 24 executives and scientists from I.G. Farben brought to justice for, among other offences, the use of slave labour in the concentration camps and forced experimentation with drugs on prisoners.

  4. Pharmaceutical industry's barriers and preferences to conduct clinical drug trials in Finland: a qualitative study.

    PubMed

    Keinonen, Tuija; Keränen, Tapani; Klaukka, Timo; Saano, Veijo; Ylitalo, Pauli; Enlund, Hannes

    2003-09-01

    The objectives of our study were to explore the barriers, preferences and attitudes of the pharmaceutical industry towards conducting clinical trials in Finland. In-depth semi-structured interviews were conducted with 18 representatives of the pharmaceutical industry with different amounts of experience of clinical trials. The interviews were audiotaped, transcribed verbatim and analysed qualitatively. Overall, the respondents had a positive attitude towards conducting clinical trials in Finland. The major barriers seemed to occur at the beginning of the trial and mostly consisted of bureaucratic obstacles. The informants hoped for a more positive attitude of the public sector, more flexibility in hospitals and professionalism in practical implementation, e.g. having special research centres or site management services. The most dismotivating factors were the high costs and the constraints imposed by bureaucracy. The variety in practices of local ethics committees was considered problematic, and the need for common standard operating procedures was pointed out. The smallest barriers were encountered in subject recruitment by the investigators and their clinical work, documentation, investigational product logistics and communication with the regulatory authorities. The quality, know-how and reliability of the study personnel, the tightening of time lines in general, an investigator register/pool and collaboration with media in disseminating information about clinical trials to the general public were reported as the most appealing factors. Training in GCP, mainly incorporated in the medical education programme, and a certificate or equivalent were generally considered necessary, though a voluntary system was preferred. The barriers and preferences pointed out suggest various improvements and ways to produce high-quality, GCP-compliant clinical drug research and to ensure the availability of sufficient conditions to carry out clinical trials also in the future.

  5. [Reduced synthesis of coenzyme Q10 may cause statin related myopathy].

    PubMed

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

    2011-11-14

    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.

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

    SciTech Connect

    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.

  7. Review of the performance of the 3T3 NRU in vitro phototoxicity assay in the pharmaceutical industry.

    PubMed

    Lynch, Anthony M; Wilcox, Phillip

    2011-03-01

    Based on current regulatory guidelines a substantial proportion of drug development portfolios within the pharmaceutical industry trigger the requirements for photosafety testing i.e. absorb light in the range 290-700 nm, and are either applied locally/topically, or 'reach' (EMEA)/'significantly partition to' (FDA) the skin or eyes. There has been growing concern within the pharmaceutical industry over recent years regarding the performance of the in vitro photosafety tests with respect to in vivo predictivity (in animals and in humans). Therefore, the Safety Ad hoc Group (SAHG) of the European Federation of Pharmaceutical Industries and Associations (EFPIA) commissioned a survey of member companies to better understand the triggers for photosafety testing and how in vitro hazard characterisation translated to in vivo risk (both in animal models and in humans). Data were collated for 361 compounds from 10 EFPIA member companies and the results of the phototoxicity survey are reported. Based on these results, it appears that the in vitro photosafety assays are substantially over predicting animal photosafety hazard in vivo and also human photosafety risk in the clinic. This raises concern regarding the use of in vitro photosafety assays for the assessment of chemical photosafety of pharmaceuticals for regulatory purposes. At the very least, a review of the current guidance documents for the photosafety evaluation of pharmaceuticals should be undertaken urgently. Copyright © 2009 Elsevier GmbH. All rights reserved.

  8. Serum levels of coenzyme Q10 in patients with Parkinson's disease.

    PubMed

    Jiménez-Jiménez, F J; Molina, J A; de Bustos, F; García-Redondo, A; Gómez-Escalonilla, C; Martínez-Salio, A; Berbel, A; Camacho, A; Zurdo, M; Barcenilla, B; Enríquez de Salamanca, R; Arenas, J

    2000-01-01

    We compared serum levels of coenzyme Q10 and the coenzyme Q10/cholesterol ratio in 33 patients with Parkinson's disease (PD) and 31 matched controls. The mean serum coenzyme Q10 levels did not differ significantly between the 2 study groups. Coenzyme Q10 levels were not correlated with age, age at onset, duration of the disease, scores of the Unified Parkinson Disease Rating Scale (UPDRS) or the Hoehn and Yahr staging in the PD group. The coenzyme Q10/cholesterol ratio had a significant correlation (although low) with duration of the disease (r = -0.46), total UPDRS score (r = -0.39), motor examination of the UPDRS (r = 0.45). These values were not influenced significantly by therapy with levodopa or dopamine agonists. The normality of serum coenzyme Q10 and coenzyme Q10/cholesterol ratio suggest that these values are not related with the risk for PD.

  9. Coenzyme Q10 Administration Increases Brain Mitochondrial Concentrations and Exerts Neuroprotective Effects

    NASA Astrophysics Data System (ADS)

    Matthews, Russell T.; Yang, Lichuan; Browne, Susan; Baik, Myong; Flint Beal, M.

    1998-07-01

    Coenzyme Q10 is an essential cofactor of the electron transport chain as well as a potent free radical scavenger in lipid and mitochondrial membranes. Feeding with coenzyme Q10 increased cerebral cortex concentrations in 12- and 24-month-old rats. In 12-month-old rats administration of coenzyme Q10 resulted in significant increases in cerebral cortex mitochondrial concentrations of coenzyme Q10. Oral administration of coenzyme Q10 markedly attenuated striatal lesions produced by systemic administration of 3-nitropropionic acid and significantly increased life span in a transgenic mouse model of familial amyotrophic lateral sclerosis. These results show that oral administration of coenzyme Q10 increases both brain and brain mitochondrial concentrations. They provide further evidence that coenzyme Q10 can exert neuroprotective effects that might be useful in the treatment of neurodegenerative diseases.

  10. Plasma Coenzyme Q10 Predicts Lipid-lowering Response to High-Dose Atorvastatin

    PubMed Central

    Pacanowski, Michael A.; Frye, Reginald F.; Enogieru, Osatohanmen; Schofield, Richard S.; Zineh, Issam

    2008-01-01

    Background Coenzyme Q10 (CoQ10) is a provitamin synthesized via the HMG-CoA reductase pathway, and thus may serve as a potential marker of intrinsic HMG-CoA reductase activity. HMG-CoA reductase inhibitors (statins) decrease CoQ10, although it is unclear whether this is due to reductions in lipoproteins, which transport CoQ10. Objectives We evaluated whether baseline plasma CoQ10 concentrations predict the lipid-lowering response to high-dose atorvastatin, and to what extent CoQ10 changes following atorvastatin therapy depend on lipoprotein changes. Methods Individuals without dyslipidemia or known cardiovascular disease (n=84) received atorvastatin 80 mg daily for 16 weeks. Blood samples collected at baseline and after 4, 8, and 16 weeks of treatment were assayed for CoQ10. Results Individuals with higher baseline CoQ10:LDL-C ratios displayed diminished absolute and percent LDL-C reductions at 8 and 16 weeks of atorvastatin treatment (P<0.001 to 0.01). After 16 weeks of atorvastatin, plasma CoQ10 decreased 45% from 762±301 ng/ml to 374±150 ng/ml (P<0.001). CoQ10 changes were correlated with LDL-C and apolipoprotein B changes (r=0.27-0.38, P=0.001-0.02), but remained significant when normalized to all lipoproteins. CoQ10 changes were not associated with adverse drug reactions. Conclusion Baseline CoQ10:LDL-C ratio was associated with the degree of LDL-C response to atorvastatin. Atorvastatin decreased CoQ10 concentrations in a manner that was not completely dependent on lipoprotein changes. The utility of CoQ10 as a predictor of atorvastatin response should be further explored in patients with dyslipidemia. PMID:19649137

  11. Misleading Advertising for Antidepressants in Sweden: A Failure of Pharmaceutical Industry Self-Regulation

    PubMed Central

    Zetterqvist, Anna V.; Mulinari, Shai

    2013-01-01

    Background The alleged efficacy of pharmaceutical industry self-regulation has been used to repudiate increased government oversight over promotional activity. European politicians and industry have cited Sweden as an excellent example of self-regulation based on an ethical code. This paper considers antidepressant advertising in Sweden to uncover the strengths and weaknesses of self-regulation. Methodology We analyzed all antidepressant advertisements in the Swedish Medical Journal, 1994–2003. The regulation of these advertisements was analyzed using case reports from self-regulatory bodies. The authors independently reviewed this material to investigate: (1) extent of violative advertising; (2) pattern of code breaches; (3) rate at which the system reacted to violative advertising; (4) prevalence of and oversight over claims regarding antidepressant efficacy and disease causality, and (5) costs for manufactures associated with violative advertising. Principal Findings Self-regulatory bodies identified numerous code breaches. Nonetheless, they failed to protect doctors from unreliable information on antidepressants, since as many as 247 of 722 (34%) advertisements breached the industry code. Self-regulatory bodies repeatedly failed to challenge inflated claims of antidepressant efficacy, lending evidence of lax oversight. On average, 15 weeks elapsed between printing and censure of a wrongful claim, and in 25% of cases 47 weeks or more elapsed. Industry paid roughly €108000 in fines for violative advertising, adding an estimated additional average cost of 11% to each purchased violative advertisement, or amounting to as little as 0.009% of total antidepressant sales of around €1.2 billion. Conclusions Lax oversight, combined with lags in the system and low fines for violations, may explain the Swedish system’s failure to pressure companies into providing reliable antidepressants information. If these shortcomings prove to be consistent across self

  12. Misleading advertising for antidepressants in Sweden: a failure of pharmaceutical industry self-regulation.

    PubMed

    Zetterqvist, Anna V; Mulinari, Shai

    2013-01-01

    The alleged efficacy of pharmaceutical industry self-regulation has been used to repudiate increased government oversight over promotional activity. European politicians and industry have cited Sweden as an excellent example of self-regulation based on an ethical code. This paper considers antidepressant advertising in Sweden to uncover the strengths and weaknesses of self-regulation. We analyzed all antidepressant advertisements in the Swedish Medical Journal, 1994-2003. The regulation of these advertisements was analyzed using case reports from self-regulatory bodies. The authors independently reviewed this material to investigate: (1) extent of violative advertising; (2) pattern of code breaches; (3) rate at which the system reacted to violative advertising; (4) prevalence of and oversight over claims regarding antidepressant efficacy and disease causality, and (5) costs for manufactures associated with violative advertising. Self-regulatory bodies identified numerous code breaches. Nonetheless, they failed to protect doctors from unreliable information on antidepressants, since as many as 247 of 722 (34%) advertisements breached the industry code. Self-regulatory bodies repeatedly failed to challenge inflated claims of antidepressant efficacy, lending evidence of lax oversight. On average, 15 weeks elapsed between printing and censure of a wrongful claim, and in 25% of cases 47 weeks or more elapsed. Industry paid roughly €108000 in fines for violative advertising, adding an estimated additional average cost of 11% to each purchased violative advertisement, or amounting to as little as 0.009% of total antidepressant sales of around €1.2 billion. Lax oversight, combined with lags in the system and low fines for violations, may explain the Swedish system's failure to pressure companies into providing reliable antidepressants information. If these shortcomings prove to be consistent across self-regulatory settings, and if appropriate measures are not taken to

  13. University-Pharmaceutical Industry Cooperation: Creation of a New Administrative Position to Broker the Placement of Clinical Trials.

    ERIC Educational Resources Information Center

    Mishler, John M.

    1989-01-01

    A pilot program at the University of Missouri-Kansas City included creation of a part-time administrative position to enhance cooperative ventures between the university and the pharmaceutical industry through placement of clinical trials among academic units with interdisciplinary research programs in the health sciences. Sponsored funding levels…

  14. Multivariate analysis in the pharmaceutical industry: enabling process understanding and improvement in the PAT and QbD era.

    PubMed

    Ferreira, Ana P; Tobyn, Mike

    2015-01-01

    In the pharmaceutical industry, chemometrics is rapidly establishing itself as a tool that can be used at every step of product development and beyond: from early development to commercialization. This set of multivariate analysis methods allows the extraction of information contained in large, complex data sets thus contributing to increase product and process understanding which is at the core of the Food and Drug Administration's Process Analytical Tools (PAT) Guidance for Industry and the International Conference on Harmonisation's Pharmaceutical Development guideline (Q8). This review is aimed at providing pharmaceutical industry professionals an introduction to multivariate analysis and how it is being adopted and implemented by companies in the transition from "quality-by-testing" to "quality-by-design". It starts with an introduction to multivariate analysis and the two methods most commonly used: principal component analysis and partial least squares regression, their advantages, common pitfalls and requirements for their effective use. That is followed with an overview of the diverse areas of application of multivariate analysis in the pharmaceutical industry: from the development of real-time analytical methods to definition of the design space and control strategy, from formulation optimization during development to the application of quality-by-design principles to improve manufacture of existing commercial products.

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

    ERIC Educational Resources Information Center

    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…

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

    ERIC Educational Resources Information Center

    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…

  17. Evaluating the "greenness" of chemical processes and products in the pharmaceutical industry--a green metrics primer.

    PubMed

    Jiménez-González, Concepción; Constable, David J C; Ponder, Celia S

    2012-02-21

    This tutorial review presents an overview of the main metrics that have been used to test and compare the 'greenness' of processes and products, primarily in the pharmaceutical industry. The green metrics cover areas of resources, materials, processing, cleaning, life cycle assessment, renewability, amongst others. Application examples of these metrics are also presented to illustrate key points and concepts.

  18. Review of patents and application of spray drying in pharmaceutical, food and flavor industry.

    PubMed

    Patel, Bhavesh B; Patel, Jayvadan K; Chakraborty, Subhashis

    2014-04-01

    Spray drying has always remained an energetic field of innovation in pharmaceutical, food and flavor industry since last couple of decades. The current communication embodies an in-depth application of spray drying in pulmonary drug delivery for production of uniform and respirable size particles suitable for nebulizers, dry powder inhalers (DPI) and pressurized metered dose inhalers (pMDI). The review also highlights spray drying application in the manufacturing of mucoadhesive formulation suitable for nasal cavities to improve the drug absorption and bioavailability. Recent research works and patents filed by various researchers on spray drying technology for solubility enhancement have also been accentuated. Benefits of spray drying in production of dry flavorings to meet a product with maximum yield and least flavor loss are also discussed. The use of spray drying in production of various food products like milk or soymilk powder, tomato pulp, dry fruit juice etc, and in encapsulation of vegetable oil or fish oil and dry creamer has been discussed. Current review also highlights the application of spray drying in the biotechnology field like production of dry influenza or measles vaccine as well as application in ceramic industry. Spray drying based patents issued by the U.S. Patent and Trademark Office in the area of drug delivery have also been included in the current review to emphasize importance of spray drying in the recent research scenario.

  19. Perspectives on the failure of pharmaceutical and medical device industries to fully protect public health interests.

    PubMed

    Maron, Barry J; Hauser, Robert G

    2007-07-01

    This discussion raises a fundamental, yet simple, public health issue--failure by the pharmaceutical and device industries to institute proper informed consent and full disclosure of critical medical information to patients (through their physicians) and recognize the autonomous right of patients to participate in important medical decisions that may affect their well-being, including the risk of death or injury. In this discussion, 2 recent affairs with high public visibility were analyzed as models illustrating these issues involving Merck and Co. (Whitehouse Station, New Jersey; for Vioxx) and Guidant Corp. (Indianapolis, Indiana; for implantable defibrillators). These scenarios proved to be remarkably similar with regard to their themes and parallel pathways and the pitfalls they illustrate. In conclusion, the focus of this review emphasizes the lessons learned and the changes already underway that will promote improved communication between industry and the physician community (and their patients) so that ultimately patient trust in the medical establishment can be restored and maintained and the errors of the past not repeated.

  20. Silo Effect a Prominence Factor to Decrease Efficiency of Pharmaceutical Industry

    PubMed Central

    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. PMID:24250690

  1. Silo effect a prominence factor to decrease efficiency of pharmaceutical industry.

    PubMed

    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.

  2. [The investment of pharmaceutical industry in hospital clinical research: an estimate for france in 2010].

    PubMed

    Fagnani, Francis

    2012-01-01

    The objective of this study was to estimate the investment of pharmaceutical industry in hospital clinical research in France for 2010. The method consisted in combining data extracted from various sources about volumes of patients and unit costs per patient according to phase (I, II and II) and therapeutic domains. The numbers of French patients enrolled were estimated through an extraction of the National Institute of Health (NIH) database. Unit costs per patient were estimated from a sample of 54 clinical studies covering the most frequent combinations of phases and therapeutic domains and documented independently by 5 international companies. We identified 1, 178 clinical studies ongoing in 2010, having included a total of about 73, 000 French patients. Among these studies, 40.3% and 12.8% concerned Onco-Haematology and Rare Diseases respectively. The total annual investment from industry was estimated at 488 million euros, comprising 83.6 M€ of medical honoraria (17%), 73 M€ of hospital extra cost (15%), 99 M€ of drug provision (20%) and 232 M€ of internal cost for french affiliates (48%).

  3. Protective effect of Co-enzyme Q10 On doxorubicin-induced cardiomyopathy of rat hearts.

    PubMed

    Chen, Pei-Yu; Hou, Chien-Wen; Shibu, Marthandam Asokan; Day, Cecilia Hsuan; Pai, Peiying; Liu, Zhao-Rong; Lin, Tze-Yi; Viswanadha, Vijaya Padma; Kuo, Chia-Hua; Huang, Chih-Yang

    2017-02-01

    Q10 is a powerful antioxidant often used in medical nutritional supplements for cancer treatment. This study determined whether Q10 could effectively prevent cardio-toxicity caused by doxorubicin treatment. Four week old SD rats were segregated into groups namely control, doxorubicin group (challenged with doxorubicin), Dox + Q10 group (with doxorubicin challenge and oral Q10 treatment), and Q10 group (with oral Q10 treatment). Doxorubicin groups received IP doxorubicin (2.5 mg/kg) every 3 days and Q10 groups received Q10 (10 mg/kg) every day. Three weeks of doxorubicin challenge caused significant reduction in heart weight, disarray in cardiomyocyte arrangement, elevation of collagen accumulation, enhancement of fibrosis and cell death associated proteins, and inhibition of survival proteins. However, Q10 effectively protected cardiomyocytes and ameliorated fibrosis and cell death induced by doxorubicin. Q10 is, therefore, evidently a potential drug to prevent heart damage caused by doxorubicin. © 2016 Wiley Periodicals, Inc. Environ Toxicol 32: 679-689, 2017. © 2016 Wiley Periodicals, Inc.

  4. Micronutrient special issue: coenzyme Q(10) requirements for DNA damage prevention.

    PubMed

    Schmelzer, Constance; Döring, Frank

    2012-05-01

    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. Copyright © 2011 Elsevier B.V. All rights reserved.

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

    NASA Astrophysics Data System (ADS)

    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.

  6. Coenzyme Q10 ameliorates oxidative stress and prevents mitochondrial alteration in ischemic retinal injury.

    PubMed

    Lee, Dongwook; Kim, Keun-Young; Shim, Myoung Sup; Kim, Sang Yeop; Ellisman, Mark H; Weinreb, Robert N; Ju, Won-Kyu

    2014-04-01

    Coenzyme Q10 (CoQ10) acts by scavenging reactive oxygen species for protecting neuronal cells against oxidative stress in neurodegenerative diseases. We tested whether a diet supplemented with CoQ10 ameliorates oxidative stress and mitochondrial alteration, as well as promotes retinal ganglion cell (RGC) survival in ischemic retina induced by intraocular pressure elevation. A CoQ10 significantly promoted RGC survival at 2 weeks after ischemia. Superoxide dismutase 2 (SOD2) and heme oxygenase-1 (HO-1) expression were significantly increased at 12 h after ischemic injury. In contrast, the CoQ10 significantly prevented the upregulation of SOD2 and HO-1 protein expression in ischemic retina. In addition, the CoQ10 significantly blocked activation of astroglial and microglial cells in ischemic retina. Interestingly, the CoQ10 blocked apoptosis by decreasing caspase-3 protein expression in ischemic retina. Bax and phosphorylated Bad (pBad) protein expression were significantly increased in ischemic retina at 12 h. Interestingly, while CoQ10 significantly decreased Bax protein expression in ischemic retina, CoQ10 showed greater increase of pBad protein expression. Of interest, ischemic injury significantly increased mitochondrial transcription factor A (Tfam) protein expression in the retina at 12 h, however, CoQ10 significantly preserved Tfam protein expression in ischemic retina. Interestingly, there were no differences in mitochondrial DNA content among control- or CoQ10-treated groups. Our findings demonstrate that CoQ10 protects RGCs against oxidative stress by modulating the Bax/Bad-mediated mitochondrial apoptotic pathway as well as prevents mitochondrial alteration by preserving Tfam protein expression in ischemic retina. Our results suggest that CoQ10 may provide neuroprotection against oxidative stress-mediated mitochondrial alterations in ischemic retinal injury.

  7. Factors affecting the chemical durability of glass used in the pharmaceutical industry.

    PubMed

    Iacocca, Ronald G; Toltl, Nick; Allgeier, M; Bustard, B; Dong, Xia; Foubert, M; Hofer, J; Peoples, S; Shelbourn, T

    2010-09-01

    Delamination, or the generation of glass flakes in vials used to contain parenteral drug products, continues to be a persistent problem in the pharmaceutical industry. To understand all of the factors that might contribute to delamination, a statistical design of experiments was implemented to describe this loss of chemical integrity for glass vials. Phase I of this study focused on the effects of thermal exposure (prior to product filling) on the surface chemistry of glass vials. Even though such temperatures are below the glass transition temperature for the glass, and parenteral compounds are injected directly into the body, data must be collected to show that the glass was not phase separating. Phase II of these studies examined the combined effects of thermal exposure, glass chemistry, and exposure to pharmaceutically relevant molecules on glass delamination. A variety of tools was used to examine the glass and the solution contained in the vial including: scanning electron microscopy and dynamic secondary ion mass spectroscopy for the glass; and visual examination, pH measurements, laser particle counting, and inductively coupled plasma-optical emission spectrometry for the analysis of the solution. The combined results of phase I and II showed depyrogenation does not play a significant role in delamination. Terminal sterilization, glass chemistry, and solution chemistry are the key factors in the generation of glass flakes. Dissolution of silica may be an effective indicator that delamination will occur with a given liquid stored in glass. Finally, delamination should not be defined by the appearance of visible glass particulates. There is a mechanical component in the delamination process whereby the flakes must break away from the interior vial surface. Delamination should be defined by the observation of flakes on the interior surface of the vial, which can be detected by several other analytical techniques.

  8. Empirical uncertainty and moral contest: a qualitative analysis of the relationship between medical specialists and the pharmaceutical industry in Australia.

    PubMed

    Doran, E; Kerridge, I; McNeill, P; Henry, David

    2006-03-01

    Alliances between the medical profession and the pharmaceutical industry have become increasingly widespread in recent years. While there are clearly benefits for doctors and their patients derived from the medical profession working with industry, concern has arisen that the commercial imperative of industry may conflict with physicians' independence and professional integrity. This paper reports the findings of an in-depth interview study with 50 Australian medical specialists undertaken to explore how and why they interact with the pharmaceutical industry and to gain insight into specialists' moral evaluation of the relationship and its consequences. Analysis of the qualitative data led to the categorizing medical specialists into three types--Confident Engagers, Ambivalent Engagers and Avoiders--based on their descriptions and evaluations of their relationship. The majority of interviewees believed that some relationship with the pharmaceutical industry was inevitable, that there were both risks and benefits associated with the relationship and that as individuals they were competent in minimizing the risks and maximizing the benefits. However, their views diverged on the extent and magnitude of the risks and benefits. The data suggested that there is considerable variance in specialists' judgments of what constituted appropriate industry largesse. Specialists' relationship with the pharmaceutical industry has inherent tensions that are managed by different doctors in different ways. Moral evaluation of the relationship and its consequences varies and the ethical concerns surrounding the relationship appeared as an area of contest. The findings suggest that in developing normative guidelines for academic and professional practice, policy makers should recognise and account for the complexity of the relationship and for the variation in medical specialists' views and feelings.

  9. "Dualities of interest": the inter-organizational relationships between disease-specific nonprofits and the pharmaceutical industry.

    PubMed

    Paluzzi, Joan E

    2012-01-01

    Health care and biomedical research environments in the United States are largely characterized by strategic relational practices conducted beyond the public gaze. The very nature of health care has been widely reconceptualized from a response to physical/biological imperatives regulated by health promotion and the epidemiological distribution of diseases to profit/market imperatives regulated by "product/brand" promotion and market dynamics. At critical decision points throughout the system, we find the multinational pharmaceutical industry wielding the influence that its wealth and power have bought. This study contributes to the growing body of work that seeks to illuminate the relationships between the pharmaceutical industry and the various entities that constitute the U.S. health and research systems. Through the use of case studies, it examines the relationships between the multinational pharmaceutical industry and the large disease-specific public and professional nonprofit organizations. It explores several questions, including: Is the concept of what constitutes a conflict of interest being purposefully manipulated? Is the public benevolence afforded to nonprofits extended to their corporate partners in ways that preclude critical oversight of relational dynamics? And are public donations, solicited by and given in good faith to these organizations, inevitably serving the economic interests and profits of donor pharmaceutical companies?

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

    PubMed

    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.

  11. The World Health Organization and the Pharmaceutical Industry. Common areas of interest and differing views.

    PubMed

    Hardwicke, Caroline J

    2002-01-01

    No article published in the scientific press in the last 10 years reviews the various areas of interest common to the World Health Organization (WHO) and the pharmaceutical industry. Despite a vast amount of information in the public domain, the policies expound the views only of the bodies they represent rather than comparing differing views. An understanding of the factors which affect the interaction between these organisations as well as the organisational structures and the actual areas of intersecting interest, may help to find ways for the industry to assist the WHO in its endeavours in developing countries. Modern drug development is performed initially in and for western society, leaving the areas of infectious or tropical diseases with relatively less industry investment than cancer and cardiovascular disorders. Aspects of the development of an ethical drug, regardless of its therapeutic class (selection of drug name, intellectual property rights, drug safety, marketing and pricing, quality assurance and counterfeiting, generic use, emerging drug donations) are influenced to varying degrees by the triad of money, politics and medical need and the perspectives (each defensible) placed thereon by the WHO and industry. Instead of simply defending their positions combining the best of these strategies to optimise drug development for the needs of developing countries appears logical. Similarly, via its philanthropic initiatives, industry will have donated over $US1 billion in drug and research aid in the period 1995 to 2005. These charitable projects should yield useful information for planning and organising future aid efforts. Global warming, only recently given serious governmental consideration, is an area not yet addressed in drug development policy although along with geographical effects, it is likely to have an impact on the epidemiology of diseases e.g. malaria returning to the Mediterranean, worldwide. With changing disease patterns (and

  12. Serum levels of coenzyme Q10 in patients with Alzheimer's disease.

    PubMed

    de Bustos, F; Molina, J A; Jiménez-Jiménez, F J; García-Redondo, A; Gómez-Escalonilla, C; Porta-Etessam, J; Berbel, A; Zurdo, M; Barcenilla, B; Parrilla, G; Enriquez-de-Salamanca, R; Arenas, J

    2000-01-01

    We compared serum levels of coenzyme Q10 and the coenzyme Q10/cholesterol ratio in 44 patients with Alzheimer's disease (AD), 17 patients with vascular dementia (VD), and 21 matched controls. The mean serum coenzyme Q10 and cholesterol levels and the coenzyme Q10/cholesterol ratio of patients with AD or VD did not differ significantly from those of controls. Coenzyme Q10 levels and coenzyme Q10/cholesterol ratio of AD or VD patients were not correlated with age, age at onset, duration of the disease or scores of the MiniMental State Examination. These results suggest that these values are not related with the risk for AD or VD.

  13. Serum levels of coenzyme Q10 in patients with multiple sclerosis.

    PubMed

    de Bustos, F; Jiménez-Jiménez, F J; Molina, J A; Gómez-Escalonilla, C; de Andrés, C; del Hoyo, P; Zurdo, M; Tallón-Barranco, A; Berbel, A; Porta-Etessam, J; Parrilla, G; Arenas, J

    2000-03-01

    To elucidate whether serum coenzyme Q10 levels are related with the risk for multiple sclerosis (MS) or are a marker for the activity of the disease, we compared serum levels of coenzyme Q10 and the coenzyme Q10/cholesterol ratio, in 31 patients with MS (during exacerbations) and 19 matched controls using a high performance liquid chromatography technique. The mean serum coenzyme Q10 levels and the coenzyme Q10/cholesterol ratio did not differ significantly between the 2 study groups. The values did not correlate with age, age at onset, and duration of the disease. These results suggest that serum coenzyme Q10 concentrations are unrelated with the risk for MS and are not a useful marker of activity of the disease.

  14. Coenzyme Q(10): a novel therapeutic approach for Fibromyalgia? case series with 5 patients.

    PubMed

    Cordero, Mario D; Alcocer-Gómez, Elísabet; de Miguel, Manuel; Cano-García, Francisco Javier; Luque, Carlos M; Fernández-Riejo, Patricia; Fernández, Ana María Moreno; Sánchez-Alcazar, José Antonio

    2011-07-01

    Coenzyme Q(10) (CoQ(10)) is an essential electron carrier in the mitochondrial respiratory chain and a strong antioxidant. Low CoQ(10) levels have been detected in patients with Fibromyalgia (FM). The purpose of the present work was to assess the effect of CoQ(10) on symptoms of five patients with FM. Patients were evaluated clinically with Visual Analogical Scale of pain (VAS), and Fibromyalgia Impact Questionnaire (FIQ). Patients with CoQ(10) deficiency showed a statistically significant reduction on symptoms after CoQ(10) treatment during 9 months (300 mg/day). Determination of deficiency and consequent supplementation in FM may result in clinical improvement. Further analysis involving more scientifically rigorous methodology will be required to confirm this observation.

  15. [Coenzyme Q10--its importance, properties and use in nutrition and cosmetics].

    PubMed

    Hojerová, J

    2000-05-01

    Coenzyme Q10, or ubiquinone, is a nutrient--a vitamin-like substance which plays a crucial role in the generation of cellular energy an in free radical scavenging in the human body. After the age of 35 to 40, the organism begins to lose its ability to synthesize Co Q10 from food and its deficiency develops. Ageing, poor eating habits, stress and infection--they all affect our ability to provide adequate amounts of Co Q10. Therefore Co Q10 supplementation may be very helpful for the organism. The present summarizing study reports the history of the discovery and research, properties, biochemical effects, dosage of Co Q10 deficiency in the human body. A possible use of Co Q10 as a dietary supplement and an ingredient for topical cosmetic products is described.

  16. Combination therapy with metformin and coenzyme Q10 in murine experimental autoimmune arthritis.

    PubMed

    Jhun, JooYeon; Lee, SeungHoon; Kim, Se-Young; Na, Hyun Sik; Kim, Eun-Kyung; Kim, Jae-Kyung; Jeong, Jeong-Hee; Park, Sung Hwan; Cho, Mi-La

    2016-01-01

    Metformin (Met) and coenzyme Q10 (CoQ10) are reported to have therapeutic functions in several inflammatory diseases. These drugs have shown anti-inflammatory effects and have been utilized in mouse models of rheumatoid arthritis (RA). However, there is no evidence of the additive effect of Met and CoQ10 in RA. Although Met and CoQ10 may be involved in the improvement of mitochondrial dysfunction, limited information is available regarding whether this effect can improve mitochondrial dysfunction in RA in particular. In this study, we sought to determine whether Met and CoQ10 attenuate the severity of collagen-induced arthritis (CIA) and show an additive effect in a mouse model. The combination of Met and CoQ10 improved CIA, reducing joint inflammation, Th17 differentiation and IgG production. In contrast, the combination of Met and CoQ10 induced Treg differentiation. Osteoclastogenesis was reduced by the combination of Met and CoQ10. The protein expression of interleukin-1β, interleukin-6 and tumor necrosis factor-alpha in mice splenocytes exposed to lipopolysaccharide decreased after drug combination therapy. We also found that the expression of JC-1 and COX IV were enhanced by treatment with the combination of Met and CoQ10. Moreover, the combination of Met and CoQ10 promoted mitochondrial O2 consumption. These findings suggest that the combination of Met and CoQ10 reduced CIA severity, improving mitochondrial dysfunction compared to Met or CoQ10 alone. These results present a novel, significant preventive targets in RA and may enhance our understanding of its pathogenesis.

  17. The impact of the cox-2 inhibitor issue on perceptions of the pharmaceutical industry: content analysis and communication implications.

    PubMed

    Lofstedt, Ragnar E

    2007-01-01

    The field of risk communication has its roots in the environmental, chemical, space, and nuclear arenas. As a number of these sectors have now vastly improved their communication strategies, attention is being placed on sectors that have been more problematic as of late. Examples of such sectors, include the food industries and the pharmaceutical/health sector. This article focuses on how large, multinational pharmaceutical companies can better communicate risks by analysis of one specific case, namely, that of the Cox-2 controversy.(1) For purposes of this article, risk communication is best described as "the flow of information and risk evaluations back and forth between academic experts, regulatory practitioners, interest groups and the general public," and "big pharma" refers to the more traditional R & D-based, innovative pharmaceutical companies.

  18. Physical activity affects plasma coenzyme Q10 levels differently in young and old humans.

    PubMed

    Del Pozo-Cruz, Jesús; Rodríguez-Bies, Elisabet; Ballesteros-Simarro, Manuel; Navas-Enamorado, Ignacio; Tung, Bui Thanh; Navas, Plácido; López-Lluch, Guillermo

    2014-04-01

    Coenzyme Q (Q) is a key lipidic compound for cell bioenergetics and membrane antioxidant activities. It has been shown that also has a central role in the prevention of oxidation of plasma lipoproteins. Q has been associated with the prevention of cholesterol oxidation and several aging-related diseases. However, to date no clear data on the levels of plasma Q during aging are available. We have measured the levels of plasmatic Q10 and cholesterol in young and old individuals showing different degrees of physical activity. Our results indicate that plasma Q10 levels in old people are higher that the levels found in young people. Our analysis also indicates that there is no a relationship between the degree of physical activity and Q10 levels when the general population is studied. However, very interestingly, we have found a different tendency between Q10 levels and physical activity depending on the age of individuals. In young people, higher activity correlates with lower Q10 levels in plasma whereas in older adults this ratio changes and higher activity is related to higher plasma Q10 levels and higher Q10/Chol ratios. Higher Q10 levels in plasma are related to lower lipoperoxidation and oxidized LDL levels in elderly people. Our results highlight the importance of life habits in the analysis of Q10 in plasma and indicate that the practice of physical activity at old age can improve antioxidant capacity in plasma and help to prevent cardiovascular diseases.

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

    PubMed

    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.

  20. Container Closure Integrity Testing-Practical Aspects and Approaches in the Pharmaceutical Industry.

    PubMed

    Brown, Helen; Mahler, Hanns-Christian; Mellman, James; Nieto, Alejandra; Wagner, Daniel; Schaar, Matthias; Mathaes, Roman; Kossinna, Juergen; Schmitting, Franz; Dreher, Sascha; Roehl, Holger; Hemminger, Markus; Wuchner, Klaus

    2017-01-01

    The assurance of sterility of a parenteral drug product, prior to any human use, is a regulatory requirement. Hence, all strategies related to container closure integrity (CCI) must demonstrate absence of microbial contamination through leaks as part of the container closure system (CCS) qualification, during manufacturing, for quality control purposes and to ensure microbiological integrity (sterility) during storage and shipment up to the end of product shelf life. Current regulatory guidances, which differ between countries and regions, provide limited detail on how to assess CCI. The new revision of USP <1207> aims to provide extensive and detailed guidance for CCI assessments for sterile products. However, practical questions and considerations are yet to be addressed by the pharmaceutical industry. These may include: (1) choice of method, for example whether a deterministic CCI method (e.g., helium leak) is preferable over the probabilistic CCI method (e.g., microbial ingress), (2) the type of primary packaging (e.g., vial, syringe, device), (3) dosage form (e.g., liquid versus lyophilisate), (4) suitable acceptance criteria, (5) appropriate sample size, (6) the most appropriate way to introduce artificial leaks into the CCS, (7) ensuring suitable assurance of CCI during drug product manufacturing, and (8) evaluating CCI under intended shipment and storage conditions (e.g., in the frozen state).A group of European industry peers have met to discuss these and other related questions in order to provide their viewpoint and best practice on practical approaches to CCI. Their perspective is provided in this white paper. Through these discussions, it became clear that there is currently no gold standard for CCI test methods or for the generation of artificial leaks; therefore flexibility toward CCI approaches is required. Although there should be flexibility, any CCI approach must consider the intended use (e.g., CCS qualification, routine manufacturing, or

  1. Impact of Corporate Governance on Research and Development Investment in the Pharmaceutical Industry in South Korea.

    PubMed

    Lee, Munjae

    2015-08-01

    The purpose of this study is to analyze the influence of the corporate governance of pharmaceutical companies on research and development (R&D) investment. The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general, and internal transactions were extracted from TS-2000 of the Korea Listed Company Association. Sample firms were those that belong to the medical substance and drug manufacturing industries. Ultimately, 786 firm-year data of 81 firms were included in the sample (unbalanced panel data). The shareholding ratio of major shareholders and foreigners turned out to have a statistically significant influence on R&D investment (p < 0.05). No statistical significance was found in the shareholding ratio of institutional investors and the ratio of outside directors. The higher the shareholding ratio of the major shareholders, the greater the R&D investment. There will be a need to establish (or switch to) a holding company structure. Holding companies can directly manage R&D in fields with high initial risks, and they can diversify these risks. The larger the number of foreign investors, the greater the R&D investment, indicating that foreigners directly or indirectly impose pressure on a manager to make R&D investments that bring long-term benefits.

  2. Patents on Phytochemicals: Methodologies of Extraction, Application in Food and Pharmaceutical Industry.

    PubMed

    Ordaz-Trinidad, Nancy; Dorantes-Alvarez, Lidia; Salas-Benito, Juan

    2015-01-01

    Patents on phytochemicals are being registered worldwide. Such phytochemicals provide benefits to human health, and include terpenoids, phenolic compounds, alkaloids, lignin, and fiber. This review has the purpose to provide a comprehensive overview of patents published in the last five years about extraction of phytochemicals and their application in the food and pharmaceutical industry. Forty eight pa- tents were analyzed and classified in four topics of interest; 1) Extraction, 2) Functional foods, 3) Biological activity, and 4) Prevention of diseases. Extraction yield of phytochemicals is the critical step. The techniques to extract phytochemicals include enzymat- ic hydrolysis, nano-particulate precipitation, salts formation and combination of solvents; however, the use of ultrasound and microwave is increasing. Patents concerning functional foods include pediatric formulations, sport drink, and compo- sitions that produce beneficial effects. Biological activity of plant extracts tested in animals or cell cultures, as antioxidant, anti-inflammatory, anticancer activity, reduction of obesity and diabetes are presented in this review. Application of phy- tochemicals in the prevention and treatment of health disorders, such as diabetes, gastritis, enteritis, topical inflammation, macular degeneration, gingivitis, prostatic hyperplasia, urinary impairments. Patents revised include 30% methodologies for extraction of phytochemicals, 16% application of phytochem- icals in food matrixes to obtain functional foods, 18% biological activity of extracts or compounds and 36% application in the prevention and treatment of illness, which reveals a great interest to protect intellectual property concerning applica- tion of phytochemicals formulations for human health.

  3. An in silico algal toxicity model with a wide applicability potential for industrial chemicals and pharmaceuticals.

    PubMed

    Önlü, Serli; Saçan, Melek Türker

    2017-04-01

    The authors modeled the 72-h algal toxicity data of hundreds of chemicals with different modes of action as a function of chemical structures. They developed mode of action-based local quantitative structure-toxicity relationship (QSTR) models for nonpolar and polar narcotics as well as a global QSTR model with a wide applicability potential for industrial chemicals and pharmaceuticals. The present study rigorously evaluated the generated models, meeting the Organisation for Economic Co-operation and Development principles of robustness, validity, and transparency. The proposed global model had a broad structural coverage for the toxicity prediction of diverse chemicals (some of which are high-production volume chemicals) with no experimental toxicity data. The global model is potentially useful for endpoint predictions, the evaluation of algal toxicity screening, and the prioritization of chemicals, as well as for the decision of further testing and the development of risk-management measures in a scientific and regulatory frame. Environ Toxicol Chem 2017;36:1012-1019. © 2016 SETAC. © 2016 SETAC.

  4. Animals on drugs: understanding the role of pharmaceutical companies in the animal-industrial complex.

    PubMed

    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.

  5. A full-scale biological treatment system application in the treated wastewater of pharmaceutical industrial park.

    PubMed

    Lei, Ge; Ren, Hongqiang; Ding, Lili; Wang, Feifei; Zhang, Xingsong

    2010-08-01

    A full-scale combined biological system is used for the treatment of treated wastewater discharged from a pharmaceutical industrial park. This treated water is rich in NH(4)(+)-N (average in 86.4 mg/L), low in COD/NH(4)(+)-N (average in 3.4) and low in BOD(5)/COD ratio (average in 0.24) with pH varying from 7.16 to 7.78. The final effluent of the combined treatment process was stably below 100mg/L COD and 20mg/L NH(4)(+)-N, separately, with organic loading rate of 4954 kg COD/d and 92.5 kg NH(4)(+)-N/d. It is found that the BOD(5)/COD ratio could be raised from 0.24 to 0.35, and the production of total VFAs account for 9.57% of the total COD via the treatment of hydrolysis/acidification. MBBR and oxidation ditch represent 35.4% and 60.7% of NH(4)(+)-N removal, 30.2% and 61.5% of COD removal, separately, of the total treatment process. PCR-DGGE is used for microbial community analysis of MBBR and oxidation ditch. (c) 2010. Published by Elsevier Ltd. All rights reserved.

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

    PubMed Central

    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 hazardous contaminants. Sources and applications of these biosorbents are presented, while factors affecting biosorption are discussed. Equilibrium, kinetics, and mechanisms of biosorption are also reviewed. In spite of the wide spread application of these biosorbents in the treatment of heavy metals and dyes, more research is required on other classes of pollutants. In addition, further work should be dedicated to studying scaling up of the process and its economic feasibility. More attention should also be given to enhancing mechanical strength, stability, life time, and reproducibility of the biosorbent. Environmental concerns regarding disposal of consumed biosorbents should be addressed by offering feasible biosorbent regeneration or pollutant immobilization options. PMID:25110656

  7. Treatment of mixed pharmaceutical industry and domestic wastewater by sequencing batch reactor.

    PubMed

    Ileri, R; Sengil, I A; Kulac, S; Damar, Y

    2003-01-01

    Raw mixed pharmaceutical industry and domestic wastewater characteristics are such as BOD5 = 90-130 mg L(-1), COD = 200-300 mg L(-1), SS = 900 mg L(-1), pH = 6.4-6.8, T = 20 degrees C, NH3 = 26 mg L(-1), PO4(3-) = 8.5 mg L(-1). In treatment plant, the parameters such as BOD5, NH3, PO4(3-), SS, MLVSS, pH, temperature, sludge volume and microorganisms predominance are studied, under constant sedimentation time (30 min) against variable aeration times. As a second step, the same parameters are studied under the constant aeration time (4 h) against variable sedimentation times. Effluent concentrations from sequencing batch reactor (SBR) are determined BOD5 = 13-18 mg L(-1), COD = 25-37 mg L(-1), SS= 9-21 mg L(-1), pH = 7.3-7.6, TDF = 1-2, T = 23 degrees C, NH3 = 1 mg L(-1), PO4(3-) = 8.1 mg L(-1). At the end of 6 h of aeration time, the efficiency of BOD5 reaches to 83%. The efficiency of BOD5 reaches to 81% under a 4 h aeration time and at 90 min sedimentation time. As a result, the optimum treatment efficiency has been taken under 4 h of aeration time and of 60 min of sedimentation time.

  8. [The scientific information that the pharmaceutical industry provides to family doctors].

    PubMed

    Rivera Casares, F; Richart Rufino, M J; Navas Cutanda, J; Rodríguez Górriz, E; Gómez Moruno, C; Gómez García, B

    2005-06-15

    To check whether the information in the written publicity that the pharmaceutical industry gives to family doctors really is based on the scientific studies that support it. Cross-sectional study. Health centre on the outskirts of a big city. Over a year, all the scientific studies that laboratory reps gave family doctors along with the advertising for medicines were collected. A total of 63 paired studies and advertising pieces were obtained. 1-3 advertising messages with each supporting study were selected and reviewed in a structured fashion. Then whether or not the messages selected were based on the study was appraised. 44.5% of the advertising messages were not based on the accompanying study; 29.9% clearly were based on the study; and in the rest there was a half-and-half relationship. There was a significant relationship between the evaluation of the advertising messages and the kind of study, masking and the kind of result variable. A high proportion of advertising messages are not based on the study that is reputed to support them. A critique of these studies has to be undertaken before the advertising messages can be looked at.

  9. Assessment of food processing and pharmaceutical industrial wastes as potential biosorbents: a review.

    PubMed

    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 hazardous contaminants. Sources and applications of these biosorbents are presented, while factors affecting biosorption are discussed. Equilibrium, kinetics, and mechanisms of biosorption are also reviewed. In spite of the wide spread application of these biosorbents in the treatment of heavy metals and dyes, more research is required on other classes of pollutants. In addition, further work should be dedicated to studying scaling up of the process and its economic feasibility. More attention should also be given to enhancing mechanical strength, stability, life time, and reproducibility of the biosorbent. Environmental concerns regarding disposal of consumed biosorbents should be addressed by offering feasible biosorbent regeneration or pollutant immobilization options.

  10. Multiplicity: discussion points from the Statisticians in the Pharmaceutical Industry multiplicity expert group.

    PubMed

    Phillips, Alan; Fletcher, Chrissie; Atkinson, Gary; Channon, Eddie; Douiri, Abdel; Jaki, Thomas; Maca, Jeff; Morgan, David; Roger, James Henry; Terrill, Paul

    2013-01-01

    In May 2012, the Committee of Health and Medicinal Products issued a concept paper on the need to review the points to consider document on multiplicity issues in clinical trials. In preparation for the release of the updated guidance document, Statisticians in the Pharmaceutical Industry held a one-day expert group meeting in January 2013. Topics debated included multiplicity and the drug development process, the usefulness and limitations of newly developed strategies to deal with multiplicity, multiplicity issues arising from interim decisions and multiregional development, and the need for simultaneous confidence intervals (CIs) corresponding to multiple test procedures. A clear message from the meeting was that multiplicity adjustments need to be considered when the intention is to make a formal statement about efficacy or safety based on hypothesis tests. Statisticians have a key role when designing studies to assess what adjustment really means in the context of the research being conducted. More thought during the planning phase needs to be given to multiplicity adjustments for secondary endpoints given these are increasing in importance in differentiating products in the market place. No consensus was reached on the role of simultaneous CIs in the context of superiority trials. It was argued that unadjusted intervals should be employed as the primary purpose of the intervals is estimation, while the purpose of hypothesis testing is to formally establish an effect. The opposing view was that CIs should correspond to the test decision whenever possible. Copyright © 2013 John Wiley & Sons, Ltd.

  11. Impact of Corporate Governance on Research and Development Investment in the Pharmaceutical Industry in South Korea

    PubMed Central

    Lee, Munjae

    2015-01-01

    Objectives The purpose of this study is to analyze the influence of the corporate governance of pharmaceutical companies on research and development (R&D) investment. Methods The period of the empirical analysis is from 2000 to 2012. Financial statements and comments in general, and internal transactions were extracted from TS-2000 of the Korea Listed Company Association. Sample firms were those that belong to the medical substance and drug manufacturing industries. Ultimately, 786 firm-year data of 81 firms were included in the sample (unbalanced panel data). Results The shareholding ratio of major shareholders and foreigners turned out to have a statistically significant influence on R&D investment (p < 0.05). No statistical significance was found in the shareholding ratio of institutional investors and the ratio of outside directors. Conclusion The higher the shareholding ratio of the major shareholders, the greater the R&D investment. There will be a need to establish (or switch to) a holding company structure. Holding companies can directly manage R&D in fields with high initial risks, and they can diversify these risks. The larger the number of foreign investors, the greater the R&D investment, indicating that foreigners directly or indirectly impose pressure on a manager to make R&D investments that bring long-term benefits. PMID:26473092

  12. Clinical trials research in pediatrics: strategies for effective collaboration between investigator sites and the pharmaceutical industry.

    PubMed

    Bush, Andrew

    2006-01-01

    There is a paucity of clinical trials work in children, which leads to the frequent use of off-label and unlicensed medications in this very vulnerable group. Clinical trials work in children may be more difficult than in adults, and there are certainly ethical constraints. However, the differences between adults and children, and at different stages of childhood development, mandate strategies to improve this situation rather than continually relying on extrapolation from adult studies. Therefore, new strategies have to be established between the pharmaceutical industry and pediatric centers to facilitate effective trials work. These must be based on a clear and mutual understanding of the differences between working with children and adults. Disease phenotypes may be completely different in children; for example, wheeze in infants is not miniature adult asthma. Clinical trial design must be practical, and a trial is more likely to succeed if a simple design is utilized, with minimal interference with school work and the work of carers. The new UK initiative, 'Medicines for Children', should go a long way towards addressing the problem, and increase the evidence base for the utilization of medications in pediatric practice.

  13. In-line optimization and control of an industrial freeze-drying process for pharmaceuticals.

    PubMed

    Pisano, Roberto; Fissore, Davide; Velardi, Salvatore A; Barresi, Antonello A

    2010-11-01

    This paper deals with the in-line optimization and control of the freeze-drying process of pharmaceuticals in vials. The proposed control system, named LyoDriver, uses a mathematical model of the process to calculate the values of the temperature of the heating fluid: the goal is to minimize the time required to get the desired amount of residual water in the dried product, and to maintain product temperature below the maximum allowed value, thus preserving product quality. The values of product temperature and residual ice content, as well as other parameters, are required to perform the calculations: these variables are estimated in-line by means of the Dynamic Parameters Estimation algorithm, an advanced tool based on the pressure rise test, but also other monitoring systems can be used. Two different control algorithms are presented and investigated by means of mathematical simulation and experiments carried out in a small industrial-type apparatus (LyoBeta 25 by Telstar). Results show the effectiveness of LyoDriver in a wide range of operating conditions, even when the process becomes mass-transfer controlled, or when the operating pressure is changed. © 2010 Wiley-Liss, Inc. and the American Pharmacists Association

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

    PubMed Central

    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. PMID:27843419

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

    PubMed

    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.

  16. Preclinical pharmacokinetic/pharmacodynamic modeling and simulation in the pharmaceutical industry: an IQ consortium survey examining the current landscape.

    PubMed

    Schuck, Edgar; Bohnert, Tonika; Chakravarty, Arijit; Damian-Iordache, Valeriu; Gibson, Christopher; Hsu, Cheng-Pang; Heimbach, Tycho; Krishnatry, Anu Shilpa; Liederer, Bianca M; Lin, Jing; Maurer, Tristan; Mettetal, Jerome T; Mudra, Daniel R; Nijsen, Marjoleen Jma; Raybon, Joseph; Schroeder, Patricia; Schuck, Virna; Suryawanshi, Satyendra; Su, Yaming; Trapa, Patrick; Tsai, Alice; Vakilynejad, Majid; Wang, Shining; Wong, Harvey

    2015-03-01

    The application of modeling and simulation techniques is increasingly common in preclinical stages of the drug discovery and development process. A survey focusing on preclinical pharmacokinetic/pharmacodynamics (PK/PD) analysis was conducted across pharmaceutical companies that are members of the International Consortium for Quality and Innovation in Pharmaceutical Development. Based on survey responses, ~68% of companies use preclinical PK/PD analysis in all therapeutic areas indicating its broad application. An important goal of preclinical PK/PD analysis in all pharmaceutical companies is for the selection/optimization of doses and/or dose regimens, including prediction of human efficacious doses. Oncology was the therapeutic area with the most PK/PD analysis support and where it showed the most impact. Consistent use of more complex systems pharmacology models and hybrid physiologically based pharmacokinetic models with PK/PD components was less common compared to traditional PK/PD models. Preclinical PK/PD analysis is increasingly being included in regulatory submissions with ~73% of companies including these data to some degree. Most companies (~86%) have seen impact of preclinical PK/PD analyses in drug development. Finally, ~59% of pharmaceutical companies have plans to expand their PK/PD modeling groups over the next 2 years indicating continued growth. The growth of preclinical PK/PD modeling groups in pharmaceutical industry is necessary to establish required resources and skills to further expand use of preclinical PK/PD modeling in a meaningful and impactful manner.

  17. Investigation of Risk Factors of Work-Related Upper-Limb Musculoskeletal Disorders in a Pharmaceutical Industry or Research Article

    NASA Astrophysics Data System (ADS)

    Pourmahabadian, Mohammad; Akhavan, Mehdi; Azam, Kamal

    This study was performed among workers of an Iranian pharmaceutical industry with the aiming to determine WRMDs prevalence and exposure assessment of WRMDs risks. In this cross-sectional study, 84 female and male workers randomly selected from five packing operations. Modified Nordic Musculoskeletal Questionnaire (NMQ) was applied to study the prevalence of WRMDs and Rapid Upper Limb Assessment (RULA) method was used for the evaluation of the exposure to risk factors associated with work-related upper limb disorders. Results showed a significant association exists between neck, lower arm and A scores group with those obtained by self-reported pain (p<0.01). Similar RULA grand scores of 3 and 4 and action level of 2 were found for workers in five packing operations. Also, the results of this study revealed that RULA method is a fairly suitable tool for the evaluation of WRMDs among packing workers in pharmaceutical industry.

  18. [Effects of a mandatory guideline that prohibit hospital doctors from accepting any form of benefits in any form from the pharmaceutical industry].

    PubMed

    Gundermann, C; Meier-Hellmann, A; Bauer, M; Hartmann, M

    2010-05-01

    Several hospitals have issued their own guidelines that regulate the conduct of staff members toward the pharmaceutical industry. The effect of theses guidelines on the attitude of the doctors toward the pharmaceutical industry in Germany has so far been unknown. This study investigated whether hospital doctors with guidelines and those without guidelines differ in their attitude toward the pharmaceutical industry. A retrospective analysis was undertaken to determine the influence of hospital guidelines on the attitude of doctors toward the pharmaceutical industry. In May 2008 all doctors in intensive care of a hospital with and one without guidelines were asked anonymously by a questionnaire about their dealings with the pharmaceutical industry. The response rate was 64.9 % (37/57) and 55.1 % (59/107) respectively. The cooperation rate in both groups was 100 %. In the hospital with guidelines every doctor was on average carrying 0.56 +/- 0.64 pharmaceutical advertising gifts with a company logo, while the average in the institution without guidelines was 1.2 +/- 0.61 advertising gifts (p = 0.026). Whereas 49 % of doctors with guidelines considered the acceptance of advertising gifts as not questionable, 81 % without guidelines did (p = 0.001; RRR = 0.65; 95 % CI = 0.48-0.91). Furthermore, 70 % of doctors in the institution with guidelines compared with 92 % of those doctors in the hospital without guidelines believed that the advertising practices of the pharmaceutical industry had no influence on their prescribing behaviour (p = 0.010; RRR = 3.6; 95 % CI = 1.36-9.52). Both groups of doctors are convinced that other doctors are more influenced by the pharmaceutical industry than they are themselves (51 % with and 37 % without guidelines, p = 0.207). 70 % and 90 %, respectively of all participants considered hospital guidelines setting standards of conduct toward the pharmaceutical industry and those not sponsored by industry to have a positive effect. Every other

  19. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants of new drug...-crystal solid-state forms. This guidance also provides information about the data the applicant should...

  20. Challenges and solutions for clinical development of new antibacterial agents: results of a survey among pharmaceutical industry professionals.

    PubMed

    Bettiol, Esther; Wetherington, Jeffrey D; Schmitt, Nicola; Harbarth, Stephan

    2015-07-01

    As the number of antibacterial medicines in the pipeline remains low, we anonymously surveyed pharmaceutical industry professionals on challenges and solutions for clinical development of these agents. Challenges were reported primarily as financial and regulatory. For multidrug-resistant organisms, there are needs for rapid diagnostic tests, new regulatory guidance, and adaptation of endpoints/trial designs. Regulators and public/private initiatives are addressing these challenges to help ensure that proposed solutions have the support of all involved stakeholders.

  1. Coenzyme Q10 counteracts testicular injury induced by sodium arsenite in rats.

    PubMed

    Fouad, Amr A; Al-Sultan, Ali Ibrahim; Yacoubi, Mohamed T

    2011-03-25

    The protective effect of coenzyme Q10 against testicular toxicity induced by sodium arsenite (10mg/kg/day, orally for two consecutive days) was investigated in rats. Coenzyme Q10 treatment (10mg/kg/day, i.p.) was applied for five consecutive days, starting three days before arsenite administration. Coenzyme Q10 significantly increased serum testosterone level which was reduced by sodium arsenite. Coenzyme Q10 significantly suppressed lipid peroxidation, restored the depleted antioxidant defenses, and attenuated the increases of tumor necrosis factor-α and nitric oxide resulted from arsenic administration. Also, the elevation of arsenic ion, and the reductions of selenium and zinc ions in testicular tissue were mitigated by coenzyme Q10. Histopathological examination showed that testicular injury mediated by arsenic was ameliorated by coenzyme Q10 treatment. Immunohistochemical analysis revealed that coenzyme Q10 significantly decreased the arsenic-induced expression of inducible nitric oxide synthase, nuclear factor-κB, Fas ligand and caspase-3 in testicular tissue. It was concluded that coenzyme Q10 represents a potential therapeutic option to protect the testicular tissue from the detrimental effects of arsenic intoxication.

  2. ADCK4 mutations promote steroid-resistant nephrotic syndrome through CoQ10 biosynthesis disruption.

    PubMed

    Ashraf, Shazia; Gee, Heon Yung; Woerner, Stephanie; Xie, Letian X; Vega-Warner, Virginia; Lovric, Svjetlana; Fang, Humphrey; Song, Xuewen; Cattran, Daniel C; Avila-Casado, Carmen; Paterson, Andrew D; Nitschké, Patrick; Bole-Feysot, Christine; Cochat, Pierre; Esteve-Rudd, Julian; Haberberger, Birgit; Allen, Susan J; Zhou, Weibin; Airik, Rannar; Otto, Edgar A; Barua, Moumita; Al-Hamed, Mohamed H; Kari, Jameela A; Evans, Jonathan; Bierzynska, Agnieszka; Saleem, Moin A; Böckenhauer, Detlef; Kleta, Robert; El Desoky, Sherif; Hacihamdioglu, Duygu O; Gok, Faysal; Washburn, Joseph; Wiggins, Roger C; Choi, Murim; Lifton, Richard P; Levy, Shawn; Han, Zhe; Salviati, Leonardo; Prokisch, Holger; Williams, David S; Pollak, Martin; Clarke, Catherine F; Pei, York; Antignac, Corinne; Hildebrandt, Friedhelm

    2013-12-01

    Identification of single-gene causes of steroid-resistant nephrotic syndrome (SRNS) has furthered the understanding of the pathogenesis of this disease. Here, using a combination of homozygosity mapping and whole human exome resequencing, we identified mutations in the aarF domain containing kinase 4 (ADCK4) gene in 15 individuals with SRNS from 8 unrelated families. ADCK4 was highly similar to ADCK3, which has been shown to participate in coenzyme Q10 (CoQ10) biosynthesis. Mutations in ADCK4 resulted in reduced CoQ10 levels and reduced mitochondrial respiratory enzyme activity in cells isolated from individuals with SRNS and transformed lymphoblasts. Knockdown of adck4 in zebrafish and Drosophila recapitulated nephrotic syndrome-associated phenotypes. Furthermore, ADCK4 was expressed in glomerular podocytes and partially localized to podocyte mitochondria and foot processes in rat kidneys and cultured human podocytes. In human podocytes, ADCK4 interacted with members of the CoQ10 biosynthesis pathway, including COQ6, which has been linked with SRNS and COQ7. Knockdown of ADCK4 in podocytes resulted in decreased migration, which was reversed by CoQ10 addition. Interestingly, a patient with SRNS with a homozygous ADCK4 frameshift mutation had partial remission following CoQ10 treatment. These data indicate that individuals with SRNS with mutations in ADCK4 or other genes that participate in CoQ10 biosynthesis may be treatable with CoQ10.

  3. Coenzyme Q10 prevents high glucose-induced oxidative stress in human umbilical vein endothelial cells.

    PubMed

    Tsuneki, Hiroshi; Sekizaki, Naoto; Suzuki, Takashi; Kobayashi, Shinjiro; Wada, Tsutomu; Okamoto, Tadashi; Kimura, Ikuko; Sasaoka, Toshiyasu

    2007-07-02

    Hyperglycemia-induced oxidative stress plays a crucial role in the pathogenesis of vascular complications in diabetes. Although some clinical evidences suggest the use of an antioxidant reagent coenzyme Q10 in diabetes with hypertension, the direct effect of coenzyme Q10 on the endothelial functions has not been examined. In the present study, we therefore investigated the protective effect of coenzyme Q10 against high glucose-induced oxidative stress in human umbilical vein endothelial cells (HUVEC). HUVEC exposed to high glucose (30 mM) exhibited abnormal properties, including the morphological and biochemical features of apoptosis, overproduction of reactive oxygen species, activation of protein kinase Cbeta2, and increase in endothelial nitric oxide synthase expression. Treatment with coenzyme Q10 strongly inhibited these changes in HUVEC under high glucose condition. In addition, coenzyme Q10 inhibited high glucose-induced cleavage of poly(ADP-ribose) polymerase, an endogenous caspase-3 substrate. These results suggest that coenzyme Q10 prevents reactive oxygen species-induced apoptosis through inhibition of the mitochondria-dependent caspase-3 pathway. Moreover, consistent with previous reports, high glucose caused upregulation of intercellular adhesion molecule 1 (ICAM-1) and vascular cell adhesion molecule 1 (VCAM-1) in HUVEC, and promoted the adhesion of U937 monocytic cells. Coenzyme Q10 displayed potent inhibitory effects against these endothelial abnormalities. Thus, we provide the first evidence that coenzyme Q10 has a beneficial effect in protecting against the endothelial dysfunction by high glucose-induced oxidative stress in vitro.

  4. ADCK4 mutations promote steroid-resistant nephrotic syndrome through CoQ10 biosynthesis disruption

    PubMed Central

    Ashraf, Shazia; Gee, Heon Yung; Woerner, Stephanie; Xie, Letian X.; Vega-Warner, Virginia; Lovric, Svjetlana; Fang, Humphrey; Song, Xuewen; Cattran, Daniel C.; Avila-Casado, Carmen; Paterson, Andrew D.; Nitschké, Patrick; Bole-Feysot, Christine; Cochat, Pierre; Esteve-Rudd, Julian; Haberberger, Birgit; Allen, Susan J.; Zhou, Weibin; Airik, Rannar; Otto, Edgar A.; Barua, Moumita; Al-Hamed, Mohamed H.; Kari, Jameela A.; Evans, Jonathan; Bierzynska, Agnieszka; Saleem, Moin A.; Böckenhauer, Detlef; Kleta, Robert; El Desoky, Sherif; Hacihamdioglu, Duygu O.; Gok, Faysal; Washburn, Joseph; Wiggins, Roger C.; Choi, Murim; Lifton, Richard P.; Levy, Shawn; Han, Zhe; Salviati, Leonardo; Prokisch, Holger; Williams, David S.; Pollak, Martin; Clarke, Catherine F.; Pei, York; Antignac, Corinne; Hildebrandt, Friedhelm

    2013-01-01

    Identification of single-gene causes of steroid-resistant nephrotic syndrome (SRNS) has furthered the understanding of the pathogenesis of this disease. Here, using a combination of homozygosity mapping and whole human exome resequencing, we identified mutations in the aarF domain containing kinase 4 (ADCK4) gene in 15 individuals with SRNS from 8 unrelated families. ADCK4 was highly similar to ADCK3, which has been shown to participate in coenzyme Q10 (CoQ10) biosynthesis. Mutations in ADCK4 resulted in reduced CoQ10 levels and reduced mitochondrial respiratory enzyme activity in cells isolated from individuals with SRNS and transformed lymphoblasts. Knockdown of adck4 in zebrafish and Drosophila recapitulated nephrotic syndrome-associated phenotypes. Furthermore, ADCK4 was expressed in glomerular podocytes and partially localized to podocyte mitochondria and foot processes in rat kidneys and cultured human podocytes. In human podocytes, ADCK4 interacted with members of the CoQ10 biosynthesis pathway, including COQ6, which has been linked with SRNS and COQ7. Knockdown of ADCK4 in podocytes resulted in decreased migration, which was reversed by CoQ10 addition. Interestingly, a patient with SRNS with a homozygous ADCK4 frameshift mutation had partial remission following CoQ10 treatment. These data indicate that individuals with SRNS with mutations in ADCK4 or other genes that participate in CoQ10 biosynthesis may be treatable with CoQ10. PMID:24270420

  5. Functional connections and pathways of coenzyme Q10-inducible genes: an in-silico study.

    PubMed

    Schmelzer, Constance; Lindner, Inka; Vock, Christina; Fujii, Kenji; Döring, Frank

    2007-10-01

    Coenzyme Q10 (CoQ10, ubiquinone) is an essential cofactor in the electron transport chain, serves as a potent antioxidant in mitochondria and lipid membranes, and is often used as a dietary supplement for a number of diseases including cardiovascular diseases. Recently, we obtained evidence that CoQ10 (Kaneka Q10) affects the expression of hundreds of human genes. To decipher the functional and regulatory connections of these genes, a literature search combined with transcription factor binding site analysis was performed using Genomatix BiblioSphere and MatInspector. This in-silico analysis revealed 17 CoQ10-inducible genes which are functionally connected by signalling pathways of G-protein coupled receptors, JAK/STAT, integrin, and beta-arrestin. Promoter analysis of these CoQ10-inducible genes showed one group of NF B-regulated genes, namely IL5, thrombin, vitronectin receptor and C-reactive protein (CRP). Furthermore, a common promoter framework containing binding sites of the transcription factor families EVI1, HOXF, HOXC, and CLOX was identified in the promoters of IL5, CRP, and vitronectin receptor. The identified CoQ10-inducible genes and pathways play an important role in inflammatory response. Since these effects are based on an in-vitro study, the effect of CoQ10 on vascular health in vivo needs to be addressed in further animal and/or human intervention studies.

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

    PubMed

    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/

  7. Ultra-small NLC for improved dermal delivery of coenyzme Q10.

    PubMed

    Schwarz, Julia C; Baisaeng, Nuttakorn; Hoppel, Magdalena; Löw, Monika; Keck, Cornelia M; Valenta, Claudia

    2013-04-15

    Coenzyme Q10 (CoQ10) acts as an antioxidant in the skin and is frequently contained in anti-aging products. In previous studies, it could be shown that nano-structured lipid carriers (NLC) with a size of about 230 nm are beneficial for the dermal delivery of CoQ10. They increased Q10 skin penetration when compared to equally sized nanoemulsion. In this study, ultra-small NLC were prepared with even smaller mean particles sizes of around 80 nm. The influence of this decrease of particle size was investigated in terms of skin permeation and penetration as well as physicochemical stability of the NLC. Improved dermal delivery of CoQ10 by ultra-small NLC could be achieved.

  8. Coenzyme Q10 and Heart Failure: A State-of-the-Art Review.

    PubMed

    Sharma, Abhinav; Fonarow, Gregg C; Butler, Javed; Ezekowitz, Justin A; Felker, G Michael

    2016-04-01

    Heart failure (HF) with either preserved or reduced ejection fraction is associated with increased morbidity and mortality. Evidence-based therapies are often limited by tolerability, hypotension, electrolyte disturbances, and renal dysfunction. Coenzyme Q10 (CoQ10) may represent a safe therapeutic option for patients with HF. CoQ10 is a highly lipophilic molecule with a chemical structure similar to vitamin K. Although being a common component of cellular membranes, CoQ10's most prominent role is to facilitate the production of adenosine triphosphate in the mitochondria by participating in redox reactions within the electron transport chain. Numerous trials during the past 30 years examining CoQ10 in patients with HF have been limited by small numbers and lack of contemporary HF therapies. The recent publication of the Q-SYMBIO randomized controlled trial demonstrated a reduction in major adverse cardiovascular events with CoQ10 supplementation in a contemporary HF population. Although having limitations, this study has renewed interest in evaluating CoQ10 supplementation in patients with HF. Current literature suggests that CoQ10 is relatively safe with few drug interactions and side effects. Furthermore, it is already widely available as an over-the-counter supplement. These findings warrant future adequately powered randomized controlled trials of CoQ10 supplementation in patients with HF. This state-of-the-art review summarizes the literature about the mechanisms, clinical data, and safety profile of CoQ10 supplementation in patients with HF.

  9. Coenzyme Q10 attenuated DMH-induced precancerous lesions in SD rats.

    PubMed

    Kim, Jung-Mi; Park, Eunju

    2010-01-01

    Coenzyme Q10 (CoQ10) is known to be a compound with mitochondrial bioenergetic functions and antioxidant activity. In this study, we evaluated the effect of CoQ10 on the formation of aberrant crypt foci (ACF) induced by 1,2-dimethylhydrazine (DMH), DMH-induced leukocytic DNA damage and gene expression of cyclooxygenase-2 (COX-2) and inducible nitric oxide synthase (iNOS) by real-time PCR in colonic mucosa of male SD rats. The animals were divided into three groups and fed a casein-based high-fat and low fiber diet (100 g lard+20 g cellulose/kg diet) with or without CoQ10 (0.4 mg in soybean oil/kg BW/d, i.p.). One week after beginning the diets, the rats were subjected to 6 wk of treatment with DMH (30 mg/kg/wk, s.c.) and CoQ10 treatments continued over the entirety of the experimental period (59 d). Administration of CoQ10 resulted in reduction of ACF numbers, to 20% of the carcinogen control value. CoQ10 supplementation induced an antigenotoxic effect on DMH-induced DNA damage in the blood cells. Colonic mucosa of DMH-injected rats had significantly greater COX-2 and iNOS gene expression than those of control rats, while treatment with CoQ10 induced an inhibitory effect on over-expression of COX-2 and iNOS in colon tumors. Our results provide evidence that CoQ10 has a protective effect on the process of colon carcinogenesis, suppressing the development of preneoplastic lesions, possibly by modulating COX-2 and iNOS gene expression in colonic mucosa and DNA damage in leukocytes, suggesting that CoQ10 has chemotherapeutic activity.

  10. Coenzyme Q10 suppresses Th17 cells and osteoclast differentiation and ameliorates experimental autoimmune arthritis mice.

    PubMed

    Jhun, JooYeon; Lee, Seung Hoon; Byun, Jae-Kyeong; Jeong, Jeong-Hee; Kim, Eun-Kyung; Lee, Jennifer; Jung, Young-Ok; Shin, Dongyun; Park, Sung Hwan; Cho, Mi-La

    2015-08-01

    Coenzyme Q10 (CoQ10) is a lipid-soluble antioxidant synthesized in human body. This enzyme promotes immune system function and can be used as a dietary supplement. Rheumatoid arthritis (RA) is an autoimmune disease leading to chronic joint inflammation. RA results in severe destruction of cartilage and disability. This study aimed to investigate the effect of CoQ10 on inflammation and Th17 cell proliferation on an experimental rheumatoid arthritis (RA) mice model. CoQ10 or cotton seed oil as control was orally administrated once a day for seven weeks to mice with zymosan-induced arthritis (ZIA). Histological analysis of the joints was conducted using immunohistochemistry. Germinal center (GC) B cells, Th17 cells and Treg cells of the spleen tissue were examined by confocal microscopy staining. mRNA expression was measured by real-time PCR and protein levels were estimated by enzyme-linked immunosorbent assay (ELISA). Flow cytometric analysis (FACS) was used to evaluate Th17 cells and Treg cells. CoQ10 mitigated the severity of ZIA and decreased serum immunoglobulin concentrations. CoQ10 also reduced RANKL-induced osteoclastogenesis, inflammatory mediators and oxidant factors. Th17/Treg axis was reciprocally controlled by CoQ10 treatment. Moreover, CoQ10 treatment on normal mouse and human cells cultured in Th17 conditions decreased the number of Th17 cells and enhanced the number of Treg cells. CoQ10 alleviates arthritis in mice with ZIA declining inflammation, Th17 cells and osteoclast differentiation. These findings suggest that CoQ10 can be a potential therapeutic substance for RA.

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

    PubMed Central

    Fischer, Alexandra; Onur, Simone; Niklowitz, Petra; Menke, Thomas; Laudes, Matthias; Rimbach, Gerald; Döring, Frank

    2016-01-01

    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. PMID:27907044

  12. [The pharmaceutical industry and specialised medical training: Residents' perceptions in Madrid, Spain].

    PubMed

    González-Rubio, Raquel; Escortell-Mayor, Esperanza; Del Cura González, Isabel

    2017-10-06

    To assess the frequency of exposure and attitudes to the pharmaceutical industry (PI) of residents in the Region of Madrid (RM), Spain, and to analyse the association with specialty, professional environment and training. Cross-sectional electronic survey in May and June 2015 of all medical residents in RM. We collected sociodemographic variables and those of interaction with the PI in four blocks: frequency of interactions, attitudes and perceptions, environment and regulatory framework, and skills; with the first two blocks we created a Synthetic PI Interaction Index (SPIII). Bivariate and multivariate analysis of logistic regression. 350 resident's responses (28% family and community medicine [FCM], 57% hospital, 15% others). Ninety-eight percent reported interacting with the PI. Twenty percent believed their prescribing was influenced by the PI and 48% believed it was influenced by other doctors. Sixty-five precent considered more training necessary. Ninety-six percent had received no information from their college of physicians, 80% did not know the regulations in their medical society and 50% were unaware of those of their institution. Hospital specialty residents showed more likelihood of SPIII ≥ percentile 75 than those of FCM (odds ratio [OR]: 3.96; 95% confidence interval [95%CI]: 1.88-8.35). Training in informal settings was associated with SPIII ≤ percentile 25 (OR: 2.83; 95%CI: 1.32-6.07). The medical residents in RM had a high level of interaction with the PI and believed its influence low. Hospital specialty residents showed more interaction with the PI. Regulations were not well known by residents and they consideredmore training necessary. Copyright © 2017 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  13. Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation.

    PubMed Central

    Herxheimer, A; Collier, J

    1990-01-01

    Since 1958 the Association of the British Pharmaceutical Industry (ABPI) has attempted to regulate the promotion of prescription medicines through its code of practice. This regulation is described and analysed for the six years 1983-8 using the reports on 302 complaints considered by its code of practice committee and annual reports. The complaints came mainly from doctors (143, 48%) and competing companies (103, 33%). The committee found a total of 379 breaches of the code in 192 (63%) of the complaints. Additional breaches were detected by informational scrutiny of advertisements by the ABPI secretariat. Analysis showed that 270 (71%) of these breaches involved possible breaches of the Medicines Act. The rules that forbid misleading or unsubstantiated information and misleading claims or comparisons were broken most often. The committee found the most frequent offenders to be Organon (32 breaches), Smith Kline and French (23), Glaxo (21), A H Robins (18), Bayer (17), Merck Sharp and Dohme (17), and Lederle (16). Often the promotion of one product led to several breaches. The promotional wars over histamine H2 receptor antagonists accounted for 33 breaches. It is estimated that in 1983-8 about 100 breaches of the code were detected a year. In the 18 years 1972-88 the Medicines Act was breached probably over 1200 times. Health ministers, by not enforcing the regulations controlling promotion, have abrogated their responsibility to the ABPI, but the evidence suggests that the code has failed to deter promotional excesses. The ABPI's wish to secure compliance with the code seems weaker than its wish to pre-empt outside criticism and action: its self regulation seems to be a service to itself rather than to the public. It is suggested that the code of practice committee should become publicly accountable, that the majority of its members should represent the health professions and the public, and that effective sanctions are needed. PMID:2106963

  14. Impact of a heterogeneous liquid droplet on a dry surface: application to the pharmaceutical industry.

    PubMed

    Bolleddula, D A; Berchielli, A; Aliseda, A

    2010-09-15

    Droplet impact has been studied for over a hundred years dating back to the pioneering work of Worthington. In fact, much of his ingenuity contributed to modern day high speed photography. Over the past 40 years significant contributions in theoretical, numerical, and experimental work have been made. Droplet impact is a problem of fundamental importance due to the wealth of applications involved, namely, spray coating, spray painting, delivery of agricultural chemicals, spray cooling, inkjet printing, soil erosion due to rain drop impact, and turbine wear. Here we highlight one specific application, spray coating. Although most studies have focused their efforts on low viscosity Newtonian fluids, many industrial applications such as spray coating utilize more viscous and complex rheology liquids. Determining dominant effects and quantifying their behavior for colloidal suspensions and polymer solutions remains a challenge and thus has eluded much effort. In the last decade, it has been shown that introducing polymers to Newtonian solutions inhibits the rebounding of a drop upon impact, Bergeron et al. Furthermore Bartolo et al. concluded that the normal stress component of the elongational viscosity was responsible for the rebounding inhibition of polymer based non-Newtonian solutions. We aim to uncover the drop impact dynamics of highly viscous Newtonian and complex rheology liquids used in pharmaceutical coating processes. The generation and impact of drops of mm and microm size drops of coating liquids and glycerol/water mixtures on tablet surfaces are systematically studied over a range of We approximately O(1-300), Oh approximately O(10(-2)-1), and Re approximately O(1-700). We extend the range of Oh to values above 1, which are not available to previous studies of droplet impacts. Outcomes reveal that splashing and rebounding are completely inhibited and the role of wettability is negligible in the early stages of impact. The maximum spreading diameter of

  15. Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation.

    PubMed

    Herxheimer, A; Collier, J

    1990-02-03

    Since 1958 the Association of the British Pharmaceutical Industry (ABPI) has attempted to regulate the promotion of prescription medicines through its code of practice. This regulation is described and analysed for the six years 1983-8 using the reports on 302 complaints considered by its code of practice committee and annual reports. The complaints came mainly from doctors (143, 48%) and competing companies (103, 33%). The committee found a total of 379 breaches of the code in 192 (63%) of the complaints. Additional breaches were detected by informational scrutiny of advertisements by the ABPI secretariat. Analysis showed that 270 (71%) of these breaches involved possible breaches of the Medicines Act. The rules that forbid misleading or unsubstantiated information and misleading claims or comparisons were broken most often. The committee found the most frequent offenders to be Organon (32 breaches), Smith Kline and French (23), Glaxo (21), A H Robins (18), Bayer (17), Merck Sharp and Dohme (17), and Lederle (16). Often the promotion of one product led to several breaches. The promotional wars over histamine H2 receptor antagonists accounted for 33 breaches. It is estimated that in 1983-8 about 100 breaches of the code were detected a year. In the 18 years 1972-88 the Medicines Act was breached probably over 1200 times. Health ministers, by not enforcing the regulations controlling promotion, have abrogated their responsibility to the ABPI, but the evidence suggests that the code has failed to deter promotional excesses. The ABPI's wish to secure compliance with the code seems weaker than its wish to pre-empt outside criticism and action: its self regulation seems to be a service to itself rather than to the public. It is suggested that the code of practice committee should become publicly accountable, that the majority of its members should represent the health professions and the public, and that effective sanctions are needed.

  16. Physicians' intent to comply with the American Medical Association's guidelines on gifts from the pharmaceutical industry

    PubMed Central

    Pinto, Sharrel L; Lipowski, Earlene; Segal, Richard; Kimberlin, Carole; Algina, James

    2007-01-01

    Objective To identify factors that predict physicians' intent to comply with the American Medical Association's (AMA's) ethical guidelines on gifts from the pharmaceutical industry. Methods A survey was designed and mailed in June 2004 to a random sample of 850 physicians in Florida, USA, excluding physicians with inactive licences, incomplete addresses, addresses in other states and pretest participants. Factor analysis extracted six factors: attitude towards following the guidelines, subjective norms (eg, peers, patients, etc), facilitating conditions (eg, knowledge of the guidelines, etc), profession‐specific precedents (eg, institution's policies, etc), individual‐specific precedents (physicians' own discretion, policies, etc) and intent. Multivariate regression modelling was conducted. Results Surveys were received from 213 physicians representing all specialties, with a net response rate of 25.5%. 62% (n = 133) of respondents were aware of the guidelines; 50% (n = 107) had read them. 48% (n = 102) thought that following the guidelines would increase physicians' credibility and professional image; 68% (n = 145) agreed that it was important to do so. Intent to comply was positively associated with attitude, subjective norms, facilitators and sponsorship of continuing medical education (CME) events, while individual‐specific precedents had a negative relationship with intent to comply. Predictors of intent (R2 = 0.52, p <0) were attitude, subjective norms, the interaction term (attitude and subjective norms), sponsorship of CME events and individual‐specific precedents. Conclusions Physicians are more likely to follow the AMA guidelines if they have positive attitudes towards the guidelines, greater subjective norms, fewer expectations of CME sponsorship and fewer individual‐specific precedents. Physicians believing that important individuals or organisations expect them to comply with the guidelines are more likely to express

  17. Peptide Therapeutics and the Pharmaceutical Industry: Barriers Encountered Translating from the Laboratory to Patients.

    PubMed

    Rafferty, John; Nagaraj, Hema; McCloskey, Alice P; Huwaitat, Rawan; Porter, Simon; Albadr, Alyaa; Laverty, Garry

    2016-01-01

    Peptides are receiving increasing interest as clinical therapeutics. These highly tunable molecules can be tailored to achieve desirable biocompatibility and biodegradability with simultaneously selective and potent therapeutic effects. Despite challenges regarding up-scaling and licensing of peptide products, their vast clinical potential is reflected in the 60 plus peptide-based therapeutics already on the market, and the further 500 derivatives currently in developmental stages. Peptides are proving effective for a multitude of disease states including: type 2 diabetes (controlled using the licensed glucagon-like peptide-1 receptor liraglutide); irritable bowel syndrome managed with linaclotide (currently at approval stages); acromegaly (treated with octapeptide somatostatin analogues lanreotide and octreotide); selective or broad spectrum microbicidal agents such as the Gram-positive selective PTP-7 and antifungal heliomicin; anticancer agents including goserelin used as either adjuvant or monotherapy for prostate and breast cancer, and the first marketed peptide derived vaccine against prostate cancer, sipuleucel-T. Research is also focusing on improving the biostability of peptides. This is achieved through a number of mechanisms ranging from replacement of naturally occurring L-amino acid enantiomers with D-amino acid forms, lipidation, peptidomimetics, N-methylation, cyclization and exploitation of carrier systems. The development of self-assembling peptides are paving the way for sustained release peptide formulations and already two such licensed examples exist, lanreotide and octreotide. The versatility and tunability of peptide-based products is resulting in increased translation of peptide therapies, however significant challenges remain with regard to their wider implementation. This review highlights some of the notable peptide therapeutics discovered to date and the difficulties encountered by the pharmaceutical industry in translating these

  18. Pricing and welfare implications of parallel imports in the pharmaceutical industry.

    PubMed

    Jelovac, Izabela; Bordoy, Catalina

    2005-03-01

    In this paper we investigate the implications of permitting parallel imports of pharmaceuticals produced by a monopoly, from one country to another. We use a model where countries differ in the patients' level of co-payment for buying pharmaceuticals, and patients differ in the utility obtained from the consumption of pharmaceuticals. We show that the effects of parallel imports on total welfare are as follows: On the one hand, when countries differ in their health system only, parallel imports decrease total welfare; On the other hand, when countries differ in the health needs of their patients only, parallel imports enhance total welfare.

  19. Novel marine actinobacteria from emerald Andaman & Nicobar Islands: a prospective source for industrial and pharmaceutical byproducts.

    PubMed

    Meena, Balakrishnan; Rajan, Lawrance Anbu; Vinithkumar, Nambali Valsalan; Kirubagaran, Ramalingam

    2013-06-22

    Andaman and Nicobar Islands situated in the eastern part of Bay of Bengal are one of the distinguished biodiversity hotspot. Even though number of studies carried out on the marine flora and fauna, the studies on actinobacteria from Andaman and Nicobar Islands are meager. The aim of the present study was to screen the actinobacteria for their characterization and identify the potential sources for industrial and pharmaceutical byproducts. A total of 26 actinobacterial strains were isolated from the marine sediments collected from various sites of Port Blair Bay where no collection has been characterized previously. Isolates were categorized under the genera: Saccharopolyspora, Streptomyces, Nocardiopsis, Streptoverticillium, Microtetraspora, Actinopolyspora, Actinokineospora and Dactylosporangium. Majority of the isolates were found to produce industrially important enzymes such as amylase, protease, gelatinase, lipase, DNase, cellulase, urease and phosphatase, and also exhibited substantial antibacterial activity against human pathogens. 77% of isolates exhibited significant hemolytic activity. Among 26 isolates, three strains (NIOT-VKKMA02, NIOT-VKKMA22 and NIOT-VKKMA26) were found to generate appreciable extent of surfactant, amylase, cellulase and protease enzyme. NIOT-VKKMA02 produced surfactant using kerosene as carbon source and emulsified upto E(24)-63.6%. Moreover, NIOT-VKKMA02, NIOT-VKKMA22 and NIOT-VKKMA26 synthesized 13.27 U/ml, 9.85 U/ml and 8.03 U/ml amylase; 7.75 U/ml, 5.01 U/ml and 2.08 U/ml of cellulase and 11.34 U/ml, 6.89 U/ml and 3.51 U/ml of protease enzyme, respectively. High diversity of marine actinobacteria was isolated and characterized in this work including undescribed species and species not previously reported from emerald Andaman and Nicobar Islands, including Streptomyces griseus, Streptomyces venezuelae and Saccharopolyspora salina. The enhanced salt, pH and temperature tolerance of the actinobacterial isolates along with their

  20. Novel marine actinobacteria from emerald Andaman & Nicobar Islands: a prospective source for industrial and pharmaceutical byproducts

    PubMed Central

    2013-01-01

    Background Andaman and Nicobar Islands situated in the eastern part of Bay of Bengal are one of the distinguished biodiversity hotspot. Even though number of studies carried out on the marine flora and fauna, the studies on actinobacteria from Andaman and Nicobar Islands are meager. The aim of the present study was to screen the actinobacteria for their characterization and identify the potential sources for industrial and pharmaceutical byproducts. Results A total of 26 actinobacterial strains were isolated from the marine sediments collected from various sites of Port Blair Bay where no collection has been characterized previously. Isolates were categorized under the genera: Saccharopolyspora, Streptomyces, Nocardiopsis, Streptoverticillium, Microtetraspora, Actinopolyspora, Actinokineospora and Dactylosporangium. Majority of the isolates were found to produce industrially important enzymes such as amylase, protease, gelatinase, lipase, DNase, cellulase, urease and phosphatase, and also exhibited substantial antibacterial activity against human pathogens. 77% of isolates exhibited significant hemolytic activity. Among 26 isolates, three strains (NIOT-VKKMA02, NIOT-VKKMA22 and NIOT-VKKMA26) were found to generate appreciable extent of surfactant, amylase, cellulase and protease enzyme. NIOT-VKKMA02 produced surfactant using kerosene as carbon source and emulsified upto E24–63.6%. Moreover, NIOT-VKKMA02, NIOT-VKKMA22 and NIOT-VKKMA26 synthesized 13.27 U/ml, 9.85 U/ml and 8.03 U/ml amylase; 7.75 U/ml, 5.01 U/ml and 2.08 U/ml of cellulase and 11.34 U/ml, 6.89 U/ml and 3.51 U/ml of protease enzyme, respectively. Conclusions High diversity of marine ac