WorldWideScience

Sample records for large pharmaceutical industry

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

    Science.gov (United States)

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

    2017-06-01

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

  2. Doctors and pharmaceutical industry.

    Science.gov (United States)

    Beran, Roy G

    2009-09-01

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

  3. Effective executive management in the pharmaceutical industry.

    Science.gov (United States)

    Tran, Hoang; Kleiner, Brian H

    2005-01-01

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

  4. Quality Systems Implementation in the Pharmaceutical Industry

    African Journals Online (AJOL)

    Nafiisah

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

  5. Mergers and innovation in the pharmaceutical industry.

    Science.gov (United States)

    Comanor, William S; Scherer, F M

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Ignacio José Godinho Delgado

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

  7. Marketing orientation in pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Prošić Danica

    2006-01-01

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

  8. Organic Colouring Agents in the Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Šuleková M.

    2017-09-01

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

  9. Metrology in Pharmaceutical Industry - A Case Study

    International Nuclear Information System (INIS)

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

    2016-01-01

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

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

    International Nuclear Information System (INIS)

    Nishijima, Kazumi; Katsuya, Yoshio

    2002-01-01

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

  11. New Product Introduction in the Pharmaceutical Industry

    DEFF Research Database (Denmark)

    Hansen, Klaus Reinholdt Nyhuus

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

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

    Science.gov (United States)

    Golec, Joseph; Vernon, John A

    2009-01-01

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

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

    Science.gov (United States)

    Srivastava, Rajesh; Chandra, Ashish; Kumar, Girish

    2004-01-01

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

  14. Globalization in the pharmaceutical industry, Part II.

    Science.gov (United States)

    Casadio Tarabusi, C; Vickery, G

    1998-01-01

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

  15. Risk Management in the Pharmaceutical Industry in Slovenian Companies

    Directory of Open Access Journals (Sweden)

    Bucalo Nina

    2017-05-01

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

  16. Bioremediation Kinetics of Pharmaceutical Industrial Effluent

    Directory of Open Access Journals (Sweden)

    M. Šabić

    2015-05-01

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

  17. The uncertainty budget in pharmaceutical industry

    DEFF Research Database (Denmark)

    Heydorn, Kaj

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

  18. Nonclinical statistics for pharmaceutical and biotechnology industries

    CERN Document Server

    2016-01-01

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

  19. Low R&D Efficiency in Large Pharmaceutical Companies

    DEFF Research Database (Denmark)

    Madsen, Erik Strøjer; Wu, Yanqing

    2016-01-01

    Large pharmaceutical companies will face serious challenges in the future when several of their blockbuster drugs run out of patents, and meanwhile a growing political pressure to stop the fast increase in health care expenditures has merged. The recent wave of mergers and acquisitions (M&A) within...... the industry can be seen as an effective means to reduce costs and compensate for the reduced earnings from patented drugs. The paper examines the main development in expenditure on research and development (R&D) and number of patents in the industry with a focus on the role of company size. The analysis...... builds on a data set containing information of both patents and R&D expenditure from the world’s top 90 largest pharmaceutical companies, as well as their account data from 2002 to 2013. The empirical part estimates the firm size effect on R&D efficiency and the amount of investment allocated to R...

  20. A vision of the pharmaceutical industry.

    Science.gov (United States)

    Muñio, S

    1998-01-01

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

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

    Science.gov (United States)

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

    2009-01-01

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

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

    Science.gov (United States)

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

    2015-04-23

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

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

    International Nuclear Information System (INIS)

    Sadat, Theo; Malcolm, Fiona

    2005-01-01

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

  4. Global gene mining and the pharmaceutical industry

    International Nuclear Information System (INIS)

    Knudsen, Lisbeth E.

    2005-01-01

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

  5. Bioremediation Kinetics of Pharmaceutical Industrial Effluent

    OpenAIRE

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

    2015-01-01

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

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

    Science.gov (United States)

    Taylor, Douglas

    2014-11-01

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

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

    Science.gov (United States)

    Jochem, Roland; Landgraf, Katja

    2010-01-01

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

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

    Science.gov (United States)

    Tannoury, Maya; Attieh, Zouhair

    2017-01-01

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

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

    International Nuclear Information System (INIS)

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

    2009-01-01

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

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

    Science.gov (United States)

    Cohen-Kohler, Jillian Clare; Esmail, Laura C

    2007-09-01

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

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

    Directory of Open Access Journals (Sweden)

    Jože Drinovec

    2001-09-01

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

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

    Science.gov (United States)

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

    2007-01-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Božo Matić

    2011-07-01

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

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

    Directory of Open Access Journals (Sweden)

    Georgiana Daniela Minculete Piko

    2014-09-01

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

  16. Cleaner production at pharmaceutical industry: first steps assessment

    Directory of Open Access Journals (Sweden)

    Edilaine Conceição Rezende

    2015-12-01

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

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

    DEFF Research Database (Denmark)

    Kratochvil, Renate; Nell, Phillip Christopher

    2017-01-01

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

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

    DEFF Research Database (Denmark)

    Kratochvil, Renate; Nell, Phillip Christopher

    2018-01-01

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

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

    African Journals Online (AJOL)

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

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

    African Journals Online (AJOL)

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

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

    Science.gov (United States)

    Holloway, Kelly

    2014-08-01

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

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

    Science.gov (United States)

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

    2014-07-01

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

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

    Science.gov (United States)

    Becker-Brüser, Wolfgang

    2010-01-01

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

  4. Grid computing in large pharmaceutical molecular modeling.

    Science.gov (United States)

    Claus, Brian L; Johnson, Stephen R

    2008-07-01

    Most major pharmaceutical companies have employed grid computing to expand their compute resources with the intention of minimizing additional financial expenditure. Historically, one of the issues restricting widespread utilization of the grid resources in molecular modeling is the limited set of suitable applications amenable to coarse-grained parallelization. Recent advances in grid infrastructure technology coupled with advances in application research and redesign will enable fine-grained parallel problems, such as quantum mechanics and molecular dynamics, which were previously inaccessible to the grid environment. This will enable new science as well as increase resource flexibility to load balance and schedule existing workloads.

  5. ASEAN GMP and pharmaceutical industries in Indonesia.

    Science.gov (United States)

    Soesilo, S; Sitorus, U

    1995-01-01

    Indonesia was appointed by the ASEAN Technical Cooperation in Pharmaceutical as a focal point and to coordinate the development of practical guidelines for the implementation of GMP. The ASEAN GMP Guidelines were endorsed by the ASEAN Technical Cooperation in Pharmaceutical in 1988, which among others required separation of Beta-Lactam dedicated facilities and three degrees of cleanliness for production areas. As it was realised that drug manufacturers in developing countries need more detailed guidelines to be able to implement the GMP, an Operational Manual for GMP was also prepared for providing examples of SOPs lay-outs, documentation etc. It was agreed by the technical cooperation group to leave the implementation of GMP to each member country. However, the ASEAN Manual for Inspection of GMP was drafted and endorsed by the group and training of ASEAN Drug Inspectors was organized to support the implementation. The ASEAN GMP is being implemented in Indonesia through a five-year, stepwise implementation plan, starting in 1989.

  6. Models for open innovation in the pharmaceutical industry.

    Science.gov (United States)

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

    2013-12-01

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

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

    Science.gov (United States)

    Rutherford, M L; Stinger, T

    2001-05-01

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

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

    Directory of Open Access Journals (Sweden)

    Burgess LJ

    2011-09-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Ershova Elena Vladimirovna

    2015-10-01

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

  11. Radiation protection in the pharmaceutical-chemical industry

    International Nuclear Information System (INIS)

    Griesser, R.

    1992-01-01

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

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

    Science.gov (United States)

    Ly, Phil

    2013-01-01

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

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

    Science.gov (United States)

    Barouni, M; Ghaderi, H; Banouei, Aa

    2012-01-01

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

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

    Science.gov (United States)

    Witty, Andrew

    2011-01-01

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

  15. Quality in the pharmaceutical industry – A literature review

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2015-10-01

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

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

    Science.gov (United States)

    Ufret, C M

    1995-01-01

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

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

    DEFF Research Database (Denmark)

    Nell, Phillip Christopher

    2013-01-01

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

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

    Science.gov (United States)

    Nozal, Raúl Rodríquez

    2011-01-01

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

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

    Science.gov (United States)

    Sufrin, Carolyn B; Ross, Joseph S

    2008-09-01

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

  1. LEAN AND SIX SIGMA CONCEPTS APPLICATION IN PHARMACEUTICAL INDUSTRY

    Directory of Open Access Journals (Sweden)

    Katarina Pavlović

    2012-03-01

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

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

    Directory of Open Access Journals (Sweden)

    Katarina Pavlović

    2011-06-01

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

  3. Phytoremediation of Industrial and Pharmaceutical Pollutants

    Directory of Open Access Journals (Sweden)

    Swarna Shikha

    2016-10-01

    Full Text Available Pollution in water bodies and soil is a major and ever-increasing environmental issue nowadays, and most conventional remediation approaches do not provide appropriate solutions. The contamination of soil is a major concern for the environment and needs to be remediated. These pollutants include complex organic compounds, heavy metals released from industries and plants and natural products such as oils from accidental release. Further the nature of pollution will be governed by the source and type of the contaminant, and other inorganic compounds are released into the environment from a number of sources like mining, smelting, electroplating, and farming. Plants can clean up many types of contaminants like metals, pesticides, oils, and explosives. Phytoremediation is emerging as a bio-based and low-cost alternative in the cleanup of heavy metal-contaminated soils.

  4. Global gene mining and the pharmaceutical industry

    DEFF Research Database (Denmark)

    Knudsen, Lisbeth Ehlert

    2005-01-01

    for the Evaluation of Medicinal Products (EMEA) having issued a position paper, the Council for International Organizations of Medical Sciences (CIOMS) having a working group on this issue, and the European Society of Human Genetics preparing background paper on 'Polymorphic sequence variants in medicine: Technical...... 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......, social, legal and ethical issues. Pharmacogenetics as an example'. Within the European project Privacy in Research Ethics and Law (PRIVIREAL), recommendations for common European guidelines for membership in research ethical committees have been discussed, balancing the interests and assuring...

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

    Science.gov (United States)

    Khanna, Arun Kumar

    2006-01-01

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

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

    Science.gov (United States)

    Huitt, William M

    2011-01-01

    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. In its initial development and ongoing maintenance it works with other American National Standards developers to harmonize the many standards associated with the design, engineering, and construction of bioprocessing facilities. This harmonization effort has established a comprehensive set of standards for the betterment of the pharmaceutical industry at large. This effort is, and will remain, very important as technology, along with new and improved product and processes, evolve into the future.

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

    OpenAIRE

    Wilma Viviers; Martie Lubbe; Ermie Steenkamp; Douglas Olivier

    2014-01-01

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

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

    Science.gov (United States)

    López Guzmán, José

    2008-01-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Allan Rodríguez Artavia

    2014-04-01

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

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

    Science.gov (United States)

    Ramchandren, Radhakrishnan; Schiffer, Charles A

    2016-03-01

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

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

    Directory of Open Access Journals (Sweden)

    Kyu-Hwan SIHN

    2015-12-01

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

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

    Science.gov (United States)

    Sihn, Kyu-Hwan

    2015-12-01

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

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

    Science.gov (United States)

    Offerhaus, L

    2004-12-18

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

  15. Managing the pharmaceutical industry-health system interface.

    Science.gov (United States)

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

    2001-12-01

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

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

    Science.gov (United States)

    Castresana, Leonardo; Mejia, Raul; Aznar, Mireya

    2005-01-01

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

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

    Science.gov (United States)

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

    2017-06-01

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

  18. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2013-04-26

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

  19. 76 FR 64945 - Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent...

    Science.gov (United States)

    2011-10-19

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

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

    Science.gov (United States)

    Lexchin, Joel

    2017-08-01

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

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

    Directory of Open Access Journals (Sweden)

    Rodríguez Nozal, Raúl

    2011-12-01

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

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

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

    Science.gov (United States)

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

    2013-01-01

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

  3. Looking at CER from the pharmaceutical industry perspective.

    Science.gov (United States)

    Dubois, Robert W

    2012-05-01

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

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

    International Nuclear Information System (INIS)

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

    1997-01-01

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

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

    Science.gov (United States)

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

    2015-03-30

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

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

    Directory of Open Access Journals (Sweden)

    Marisa Ohba

    2007-06-01

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

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

    Science.gov (United States)

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

    2016-01-01

    The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 8 deals with products from Lundbeck. Lundbeck which today is known as a considerable international pharmaceutical company could in 2015 celebrate its 100 years' jubilee. Among the early Danish medicinal companies H. Lundbeck & Co. is in many ways an exception as the company was not originally established as a pharmaceutical company. Not until several years after the foundation the company began to import foreign ready-made medicinal products and later-on to manufacture these medicinal products in own factory and even later to do research and development of own innovative products. When Lundbeck was established in 1915 several Danish medicinal companies, not only the well-known such as Alfred Benzon and Løvens kemiske Fabrik (LEO Pharma), but also Skelskør Frugtplantage, Ferrin and Ferraton, had emerged due to the respective enterprising pharmacy owners who had expanded their traditional pharmacy business and even with commercial success. Other medicinal companies, such as C.R. Evers & Co., Leerbeck & Holms kemiske Fabriker, Chr. F. Petri, Erslevs kemiske Laboratorium, Edward Jacobsen, Th. Fallesen-Schmidt, and yet other companies which were named after the founder had all been established by pharmacists with the primary intention to manufacture and sell medicinal products. Also for the limited companies Medicinalco, Ferrosan, Pharmacia, and GEA the primary task was to manufacture and sell medicinal products, and also in these companies pharmacists were involved in the foundation. Not until 1924, fully 9 years after the foundation, Lundbeck started to be interested in medicinal products and initiated import and sale of foreign medicinal products manufactured by a.o. German and French companies which had not established their own sales companies in Denmark. Almost all contemporary Danish manufacturers of

  8. Spin-off and Innovation in the Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Enzo Peruffo

    2014-11-01

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

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

    International Nuclear Information System (INIS)

    Hernandez Gonzalez, Ignacio

    2012-01-01

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

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

    Science.gov (United States)

    Paranhos, Julia; Hasenclever, Lia

    2011-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Aldo De Ferrari

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

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

    Science.gov (United States)

    Epstein, Richard J

    2007-10-01

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

  13. Software for rapid prototyping in the pharmaceutical and biotechnology industries.

    Science.gov (United States)

    Kappler, Michael A

    2008-05-01

    The automation of drug discovery methods continues to develop, especially techniques that process information, represent workflow and facilitate decision-making. The magnitude of data and the plethora of questions in pharmaceutical and biotechnology research give rise to the need for rapid prototyping software. This review describes the advantages and disadvantages of three solutions: Competitive Workflow, Taverna and Pipeline Pilot. Each of these systems processes large amounts of data, integrates diverse systems and assists novice programmers and human experts in critical decision-making steps.

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

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

    Lassen, Lars Christian; Thomsen, Mads Krogsgaard

    2007-02-01

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

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

    Science.gov (United States)

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

    2012-03-01

    Study of marketing norm perception among medical representatives is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the perception of marketing norms among medical representatives. The research design is quantitative and cross sectional study with medical representatives as unit of analysis. Data is collected from medical representatives (n=300) using a simple random and cluster sampling using a structured questionnaire. Results indicate that there is no difference in the perception of marketing norms among male and female medical representatives. But there is a difference in opinion among domestic and multinational company's medical representatives. Educational back ground of medical representatives also shows the difference in opinion among medical representatives. Degree holders and multinational company medical representatives have high perception of marketing norms compare to their counterparts. The researchers strongly believe that mandatory training on marketing norms is beneficial in decision making process during the dilemmas in the sales field.

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

    Science.gov (United States)

    Munos, Bernard H; Chin, William W

    2011-06-29

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

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

    Science.gov (United States)

    Barrett, J S; Koprowski, S P

    2002-03-01

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

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

    Science.gov (United States)

    Yan, Gujun

    2014-07-01

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

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

    African Journals Online (AJOL)

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

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

    Misra, Sahana; Ganzini, Linda; Keepers, George

    2010-01-01

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

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

    Science.gov (United States)

    Lobo, F

    1979-01-01

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

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

    Science.gov (United States)

    Salazar, A; Howells, J

    2000-01-01

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

  7. Alkaloids in the pharmaceutical industry: Structure, isolation and application

    Directory of Open Access Journals (Sweden)

    Nikolić Milan

    2003-01-01

    Full Text Available By the end of the 18th and the beginning of the 19th century a new era began in medicine, pharmaceutics and chemistry that was strongly connected with alkaloids and alkaloid drugs. Even before that it was known that certain drugs administered in limited doses were medicines, and toxic if taken in larger doses (opium, coke leaves, belladonna roots, monkshood tubers crocus or hemlock seeds. However, the identification, isolation and structural characterization of the active ingredients of the alkaloid drugs was only possible in the mid 20th century by the use of modern extraction equipment and instrumental methods (NMR, X-ray diffraction and others.In spite of continuing use over a long time, there is still great interest in investigating new drugs, potential raw materials for the pharmaceutical industry, as well as the more detailed investigation and definition of bio-active components and the indication of their activity range, and the partial synthesis of new alkaloid molecules based on natural alkaloids. The scope of these investigations, especially in the field of semi-synthesis is to make better use of the bio-active ingredients of alkaloid drugs, i.e. to improve the pharmacological effect (stronger and prolonged effect of the medicine, decreased toxicity and side effects, or to extend or change the applications. A combined classification of alkaloids was used, based on the chemical structure and origin, i.e. the source of their isolation to study alkaloid structure. For practical reasons, the following classification of alkaloids was used: ergot alkaloids, poppy alkaloids, tropanic alkaloids purine derivative alkaloids, carbon-cyclic alkaloids, and other alkaloids. The second part of this report presents a table of general procedures for alkaloid isolation from plant drugs (extraction by water non-miscible solvents, extraction by water-miscible solvents and extraction by diluted acid solutions. Also, methods for obtaining chelidonine and

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2017-08-30

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

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

    Science.gov (United States)

    Nhaili, Hicham; Taoufik, Jamal

    2015-06-01

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

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

    Science.gov (United States)

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

    2013-12-01

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

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

    International Nuclear Information System (INIS)

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

    2011-01-01

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

  13. Combined aerobic and physicochemical treatment of pharmaceutical industry sludge

    International Nuclear Information System (INIS)

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

    2005-01-01

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

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

    Science.gov (United States)

    Hillisch, Alexander; Heinrich, Nikolaus; Wild, Hanno

    2015-12-01

    Computational chemistry within the pharmaceutical industry has grown into a field that proactively contributes to many aspects of drug design, including target selection and lead identification and optimization. While methodological advancements have been key to this development, organizational developments have been crucial to our success as well. In particular, the interaction between computational and medicinal chemistry and the integration of computational chemistry into the entire drug discovery process have been invaluable. Over the past ten years we have shaped and developed a highly efficient computational chemistry group for small-molecule drug discovery at Bayer HealthCare that has significantly impacted the clinical development pipeline. In this article we describe the setup and tasks of the computational group and discuss external collaborations. We explain what we have found to be the most valuable and productive methods and discuss future directions for computational chemistry method development. We share this information with the hope of igniting interesting discussions around this topic. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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

    Science.gov (United States)

    Lewen, Nancy

    2011-06-25

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

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

    Science.gov (United States)

    Jutel, Annemarie; Menkes, David B

    2009-06-01

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

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

    NARCIS (Netherlands)

    OMTA, SWF; BOUTER, LM; VANENGELEN, JML

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

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

    African Journals Online (AJOL)

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

  19. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Science.gov (United States)

    2012-10-02

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

  20. The Industry of Pharmaceuticals between Competitive Development and Welfare

    OpenAIRE

    Gianfrate Fabrizio

    2007-01-01

    This paper would like to give a contribution to the discussion on which policies and rules should be adopted in order to relaunch the pharmaceutical sector in Italy. Due to its intrinsic features, social value and being one of the most regulated and strategic as based on innovation, this sector has higly specific economic and market peculiarities. Compatibility between the level of NHS expenditure for pharmaceutical provision, equity on medicines acces by the population without any kind of di...

  1. The emerging role of MD Pharmacology postgraduate in pharmaceutical industry

    OpenAIRE

    Pratishtha Banga Chaudhari

    2016-01-01

    Patient-benefit is a shared goal of the pharmaceutical company and the treating doctor. At the same time, the pharmaceutical company- in order to recur its R and D costs has to balance patient centricity with making profits. Consequently, the commercial benefits from prescription of a product and education about optimal use of product both become the responsibilities of same organization. This often leads to allegations of bias by the regulators. We are in an era where regulatory bodies close...

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

    DEFF Research Database (Denmark)

    Nell, Phillip Christopher

    2013-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2010-09-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Heyoung Yang

    2018-01-01

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

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

    Science.gov (United States)

    Yang, Y Tony; Chen, Brian

    2014-01-01

    Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.

  8. Internationalization and technological leapfrogging in the pharmaceutical industry

    OpenAIRE

    Suma Athreye; Andrew Godley

    2009-01-01

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

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

    Science.gov (United States)

    Abou-Gharbia, Magid; Childers, Wayne E

    2013-07-25

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

  10. Supply chain security orientation in the pharmaceutical industry ...

    African Journals Online (AJOL)

    Supply chain security orientation is an abstract phenomenon, which, up to now, has received little research attention. The purpose of this study, therefore, was to explore the supply chain security orientation of firms participating in the South African pharmaceutical supply chain with the aim of identifying specific risks and of ...

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

    Science.gov (United States)

    Malhotra, Prabodh

    2008-01-01

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

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

    OpenAIRE

    Adam J. Fein

    1998-01-01

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

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

    Science.gov (United States)

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

    2016-11-03

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

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

    Science.gov (United States)

    Semin, Semih; Güldal, Dilek

    2008-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2011-02-15

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

  16. Application of ion chromatography in clinical studies and pharmaceutical industry.

    Science.gov (United States)

    Michalski, Rajmund

    2014-01-01

    Ion chromatography is a well-established regulatory method for analyzing anions and cations in environmental, food and many other samples. It offers an enormous range of possibilities for selecting stationary and mobile phases. Additionally, it usually helps to solve various separation problems, particularly when it is combined with different detection techniques. Ion chromatography can also be used to determine many ions and substances in clinical and pharmaceutical samples. It provides: availability of high capacity stationary phases and sensitive detectors; simple sample preparation; avoidance of hazardous chemicals; decreased sample volumes; flexible reaction options on a changing sample matrix to be analyzed; or the option to operate a fully-automated system. This paper provides a short review of the ion chromatography applications for determining different inorganic and organic substances in clinical and pharmaceutical samples.

  17. Inherent Anticipation in the Pharmaceutical and Biotechnology Industries.

    Science.gov (United States)

    Goldman, Michael; Evans, Georgia; Zappia, Andrew

    2015-04-15

    Pharmaceutical and biotech research often involves discovering new properties of, or new methods to use, existing compositions. The doctrine of inherent anticipation, however, prevents the issuance and/or validity of a patent for discoveries deemed to have been implicitly disclosed in the prior art. This can be a barrier to patent rights in these technologies. Inherent anticipation therefore creates uncertainty for patent protection in the pharmaceutical and biotech sciences. Despite this uncertainty, Federal Circuit jurisprudence provides guidance on the boundaries of the inherent anticipation doctrine. In view of the case law, certain strategies may be employed to protect inventions that may potentially be viewed as inherent in the prior art. Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.

  18. The Sources of Quality in the Pharmaceutical Industry

    OpenAIRE

    Enrique Yacuzzi; Fernando Martín; Gabriel Vignola; Verónica Mayochi; Dante Tollio

    2004-01-01

    This paper analyzes the sources of quality of a pharmaceutical product. After identifying eight quality dimensions, a framework of hypothetical sources that contribute the most to shape those dimensions is established. The framework, based on Garvin's pioneering work, is applied to case studies of laboratories operating in Argentina. Framework relevance is considered using correlation analysis. Laboratories are ranked through expert opinion by the quality of its products using the eight dimen...

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

    Science.gov (United States)

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

    2014-04-03

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

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

    Science.gov (United States)

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

    2012-12-01

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

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

    CERN Document Server

    Krause, Andreas

    2001-01-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    CSIR Research Space (South Africa)

    Gouws, JF

    2007-05-01

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

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

    NARCIS (Netherlands)

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

    2005-01-01

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

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

    Directory of Open Access Journals (Sweden)

    مراد محمد النشمي

    2017-12-01

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

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

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

    2009-01-01

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

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

    OpenAIRE

    Du Plooy, Hilde

    2012-01-01

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

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

    Science.gov (United States)

    Bergström, Richard

    2011-04-01

    The established market model for pharmaceutical products, as for most other products, is heavily dependent on sales volumes. Thus, it is a primary interest of the producer to sell large quantities. This may be questionable for medicinal products and probably most questionable for antibacterial remedies. For these products, treatment indications are very complex and encompass both potential patient benefits, possible adverse effects in the actual patient and, which is unique for this therapeutic class, consideration about what effects the drug use will have on the future therapeutic value of the drug. This is because bacteria are sure to develop resistance. The European Federation of Pharmaceutical Industries and Associations (EFPIA) agrees with the general description of the antibacterial resistance problem and wants to participate in measures to counteract antibacterial resistance. Stakeholders should forge an alliance that will address the need for and prudent use of new antibiotics. A variety of incentives probably have to be applied, but having all in common that the financial return has to be separated from the use of the product. Copyright © 2011. Published by Elsevier Ltd.

  10. Chemometrics-based process analytical technology (PAT) tools: applications and adaptation in pharmaceutical and biopharmaceutical industries.

    Science.gov (United States)

    Challa, Shruthi; Potumarthi, Ravichandra

    2013-01-01

    Process analytical technology (PAT) is used to monitor and control critical process parameters in raw materials and in-process products to maintain the critical quality attributes and build quality into the product. Process analytical technology can be successfully implemented in pharmaceutical and biopharmaceutical industries not only to impart quality into the products but also to prevent out-of-specifications and improve the productivity. PAT implementation eliminates the drawbacks of traditional methods which involves excessive sampling and facilitates rapid testing through direct sampling without any destruction of sample. However, to successfully adapt PAT tools into pharmaceutical and biopharmaceutical environment, thorough understanding of the process is needed along with mathematical and statistical tools to analyze large multidimensional spectral data generated by PAT tools. Chemometrics is a chemical discipline which incorporates both statistical and mathematical methods to obtain and analyze relevant information from PAT spectral tools. Applications of commonly used PAT tools in combination with appropriate chemometric method along with their advantages and working principle are discussed. Finally, systematic application of PAT tools in biopharmaceutical environment to control critical process parameters for achieving product quality is diagrammatically represented.

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

    Science.gov (United States)

    Morgan, Steve; McMahon, Meghan; Greyson, Devon

    2008-08-01

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

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

    Directory of Open Access Journals (Sweden)

    Kirsten E Austad

    2011-05-01

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

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

    OpenAIRE

    Campins, Mónica; Pfeiffer, Ana

    2017-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Z. A. Mamedyarov

    2017-01-01

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

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

    Science.gov (United States)

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

    2015-03-01

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

  16. The duty of the pharmacist and the pharmaceutical industry.

    Science.gov (United States)

    Dwyer, Peter

    2003-01-01

    The common law duty of care, an essential element of the tort of negligence, focuses on conduct. Accordingly, any discussion of the existence, nature and content of the duty of care of a pharmaceutical manufacturer and of a pharmacist, requires analysis of their respective functions. Also relevant are the special nature and effects of drug products and their approval for and acceptance in, human therapy based upon a balancing of risks and benefits. Critical to a manufacturer's potential tortuous liability is the so-called 'learned intermediary, role of pharmacists, prescribers and other health professionals and whether they have current and accurate drug product information. Manufacturers are not necessarily the only source of drug information available to health professionals. These responsibilities serve patients who also need to be adequately informed so as to achieve optimal safety and efficacy when using prescribed medications.

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

    Science.gov (United States)

    Janero, David R

    2014-11-01

    The significant contribution of substance-use disorders (SUDs) to the global-disease burden and associated unmet medical needs has not engendered a commensurate level of pharma-industry research and development (R&D) for novel SUD therapeutics invention. Analysis of contextual factors shaping this position suggests potential routes toward incentivizing R&D commitment for that purpose. This article considers multiple primary factors that have consorted to disincentivize pharma industry's operating in the SUD space: ill-understood pathology; variegated treatments and patient profiles; involved clinical trials; and - with particular reference to SUDs-negative cultural/business stigmas and shallow commercial precedent. Industry incentivization for SUD drug innovation requires progress on several fronts, including: translational experimental data and systems; personalized, holistic SUD treatment approaches; interactions among pharma, nonindustry constituencies, and the medical profession with vested interests in countering negative stereotypes and expanding SUD treatment options; and public-private alliances focused on improving SUD pharmacotherapy. Given the well-entrenched business stance whereby the prospect of future profits in major markets largely determines drug-company R&D investment trajectory, strategic initiatives offering substantial reductions in the risks and opportunity (i.e., time and money) costs associated with SUD drug discovery are likely to be the most potent drivers for encouraging mainstream industry positioning in this therapeutic area. Such initiatives could originate from front-loaded R&D operational and back-loaded patent, regulatory, marketing and health-care policy reforms. These may be too involved and protracted for the turbulent pharmaceutical industry to entertain amid its recent retrenchment from psychiatric/CNS diseases and intense pressures to increase productivity and shareholder value.

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

    Science.gov (United States)

    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.

  19. Competitive Intelligence in Malaysia Pharmaceutical Industry : Effectiveness of Implementation

    OpenAIRE

    Ooi, Hooi Min

    2004-01-01

    Competitive Intelligence is increasingly being considered an important, if not mandatory, piece of every business’ overall strategy and functioning, including tactical and strategic planning. The level of Competitive Intelligence activities differ by industries, and at different stage of product life cycle. It is closely linked to Knowledge Management – another major field on the way company handling information. Competitive Intelligence has often been related to industrial espionage where so...

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2014-06-13

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

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

    Science.gov (United States)

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

    2005-11-28

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

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

    Science.gov (United States)

    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

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

    NARCIS (Netherlands)

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

    2015-01-01

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

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

    Czech Academy of Sciences Publication Activity Database

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

    2012-01-01

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

  7. Deciphering the therapeutic stem cell strategies of large and midsize pharmaceutical firms.

    Science.gov (United States)

    Vertès, Alain A

    2014-01-01

    The slow adoption of cytotherapeutics remains a vexing hurdle given clinical progress achieved to date with a variety of stem cell lineages. Big and midsize pharmaceutical companies as an asset class still delay large-scale investments in this arena until technological and market risks will have been further reduced. Nonetheless, a handful of stem cell strategic alliance and licensing transactions have already been implemented, indicating that progress is actively monitored, although most of these involve midsize firms. The greatest difficulty is, perhaps, that the regenerative medicine industry is currently only approaching the point of inflexion of the technology development S-curve, as many more clinical trials read out. A path to accelerating technology adoption is to focus on innovation outliers among healthcare actors. These can be identified by analyzing systemic factors (e.g., national science policies and industry fragmentation) and intrinsic factors (corporate culture, e.g., nimble decision-making structures; corporate finance, e.g., opportunity costs and ownership structure; and operations, e.g., portfolio management strategies, threats on existing businesses and patent expirations). Another path is to accelerate the full clinical translation and commercialization of an allogeneic cytotherapeutic product in any indication to demonstrate the disease-modifying potential of the new products for treatment and prophylaxis, ideally for a large unmet medical need such as dry age-related macular degeneration, or for an orphan disease such as biologics-refractory acute graft-versus-host disease. In times of decreased industry average research productivities, regenerative medicine products provide important prospects for creating new franchises with a market potential that could very well mirror that achieved with the technology of monoclonal antibodies.

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

    Directory of Open Access Journals (Sweden)

    Aída Salazar García

    2015-01-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    John Jairo Gallo Castro

    2010-01-01

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

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

    Science.gov (United States)

    Lipworth, Wendy; Montgomery, Kathleen; Little, Miles

    2013-10-01

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

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

    Directory of Open Access Journals (Sweden)

    Markéta Lőrinczy

    2015-01-01

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

  13. MANAGING INDUSTRIAL PHARMACEUTICAL RESEARCH-AND-DEVELOPMENT - A COMPARATIVE-STUDY OF MANAGEMENT CONTROL AND INNOVATIVE EFFECTIVENESS IN EUROPEAN AND ANGLO-AMERICAN COMPANIES

    NARCIS (Netherlands)

    OMTA, SWF; BOUTER, LM; VANENGELEN, JML

    1994-01-01

    Drug regulation and pricing have put strong pressure on the cost-benefit ratio of the innovative pharmaceutical industry. Therefore a study has been conducted in fourteen large and medium sized companies to determine some important organisational and managerial factors influencing success in

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

    Science.gov (United States)

    Watkins, Raquel S; Kimberly, James

    2004-05-01

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

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

    Science.gov (United States)

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

    2004-11-01

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

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

    Science.gov (United States)

    Edwards, Brian

    2004-01-01

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

  17. Industrial Physics Careers: A Large Company Perspective

    Science.gov (United States)

    Zollner, Stefan

    2009-03-01

    Statistical data from the American Institute of Physics and the National Science Foundation show that only about a third of physics graduates get permanent jobs in academia. A few work in government labs and hospitals. The majority of physics Ph.D.s, however, find employment in the private sector (industry). This trend has been increasing, i.e., recent Ph.D.s are even more likely to start careers in industry. Industrial physicists work in small, medium or large companies in a broad range of fields, including aerospace, semiconductors, automotive, energy, information technology, contract research, medical, chemical, optics, etc. They are also represented in fields outside of physics, such as finance. Even the ``inventor'' of the Powerball lottery game is a Ph.D. physicist. In my talk, I will describe pathways to success for an industrial physicist, from the perspective of employment in three different large corporations. Based on the NIST Baldridge criteria of Performance Excellence, I will discuss how to achieve and measure organizational success through focus on products and customers. Individual performance is linked to the goals of the organization. Performance has two components: Goals and behaviors. Both are key to success as an individual contributor or manager.[4pt] References: [0pt] http://www.aip.org/statistics/trends/emptrends.html [0pt] http://www.aps.org/about/governance/committees/commemb/index.cfm [0pt] http://www.quality.nist.gov/

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    Marta Makowska

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

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

    Science.gov (United States)

    Makowska, Marta

    2017-01-01

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

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

    Science.gov (United States)

    2017-01-01

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

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

    Science.gov (United States)

    Chakraborty, Sweta; Bouder, Frederic

    2013-02-01

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

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

    Science.gov (United States)

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

    2011-01-01

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

  4. A survey of the effects of brand value on customer satisfaction in pharmaceutical and biological industries

    OpenAIRE

    Alipour, A.; Feizi, S.J.; Heidari, M.

    2016-01-01

    . The purpose of this study was to describe how companies in pharmaceutical and biological sectors can ensure their position in different markets by relying on sustainable, competitive advantages, resulting from the use of a well-defined marketing model with particular emphasis on brand improvement. As competition becomes more intense among companies and phenomena such as global marketing grow in importance, domestic industries in each country become obliged to improve their competitive advan...

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

    Science.gov (United States)

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

    2018-01-01

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

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

    OpenAIRE

    Nagashekhara, Molugulu; Agil, Syed Omar Syed

    2012-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

    Bettina Schwarzer

    1995-01-01

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

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

    Directory of Open Access Journals (Sweden)

    AYOE YUSUFOGLU

    2004-01-01

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

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

    OpenAIRE

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

    2009-01-01

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

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

    Science.gov (United States)

    Amiri, Marjan; Michel, Martin C

    2015-06-01

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

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

    Science.gov (United States)

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

    2007-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Anna Skowrońska

    2015-04-01

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

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

    Directory of Open Access Journals (Sweden)

    N. O. Tkachenko

    2016-12-01

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

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

    Science.gov (United States)

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

    2012-06-01

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

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

    Science.gov (United States)

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

    2016-10-01

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

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

    Science.gov (United States)

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

    2008-12-01

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

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

    Science.gov (United States)

    Skrepnek, Grant H

    2004-01-01

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

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

    Science.gov (United States)

    Mittra, James; Tait, Joyce; Wield, David

    2011-03-01

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

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

    Directory of Open Access Journals (Sweden)

    Shamba Chatterjee

    2014-10-01

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

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

    Science.gov (United States)

    Magazzini, Laura; Pammolli, Fabio; Riccaboni, Massimo

    2004-06-01

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

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

    Science.gov (United States)

    Nagashekhara, Molugulu; Agil, Syed Omar Syed

    2011-12-01

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

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

    Science.gov (United States)

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

    2005-04-01

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

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

    Directory of Open Access Journals (Sweden)

    Kamal Uddin Zaidi

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Z. A. Mamedyarov

    2017-01-01

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

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

    CERN Document Server

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2017-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Laura M Coughlan

    2015-06-01

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

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

    Science.gov (United States)

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

    2012-08-01

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

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

    Science.gov (United States)

    Lens, S

    1993-06-01

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

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

    Directory of Open Access Journals (Sweden)

    Jovanović Vesna R.

    2017-01-01

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

  13. Elimination of micropollutants and hazardous substances at the source in the chemical and pharmaceutical industry.

    Science.gov (United States)

    Blöcher, C

    2007-01-01

    Industrial wastewater, especially from chemical and pharmaceutical production, often contains substances that need to be eliminated before being discharged into a biological treatment plant and following water bodies. This can be done within the production itself, in selected waste water streams or in a central treatment plant. Each of these approaches has certain advantages and disadvantages. Furthermore, a variety of wastewater treatment processes exist that can be applied at each stage, making it a challenging task to choose the best one in economic and ecological terms. In this work a general approach for that and examples from practice are discussed.

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

    Directory of Open Access Journals (Sweden)

    Baldissera Giovani

    2017-04-01

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

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

    Science.gov (United States)

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

    2012-03-06

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

  16. Do large mergers increase or decrease the productivity of pharmaceutical R&D?

    Science.gov (United States)

    Ringel, Michael S; Choy, Michael K

    2017-12-01

    There is current uncertainty regarding the effects of mergers on pharmaceutical R&D productivity, with various mechanisms reported by which mergers could either help or harm R&D, and mixed empirical findings in prior analyses. Here, we present an analysis that is novel in several ways: we use downstream measures of R&D productivity, account for both inputs and outputs in our calculations, and use a self-controlled design. We find that recent large pharmaceutical mergers are associated with statistically significant increases in R&D productivity. These results are perhaps not surprising in light of the broader literature on R&D productivity that points to two factors as instrumental in driving higher R&D productivity (depth of scientific information, and objectivity of decision-making based on that information), both of which could be expected to increase because of a merger. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

    International Nuclear Information System (INIS)

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

    2009-01-01

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

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

    Science.gov (United States)

    Gretton, Linda Burak

    2009-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Abofele Khoele

    2014-08-01

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

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

    Science.gov (United States)

    Expósito, Antonio J; Durán, Antonio; Monteagudo, José M; Acevedo, Alba

    2016-05-01

    An industrial wastewater effluent coming from a pharmaceutical laboratory has been treated in a semi-industrial autonomous solar compound parabolic collector (CPC) plant. A photo-Fenton process assisted with ferrioxalate has been used. Up to 79% of TOC can be removed in 2 h depending on initial conditions when treating an aqueous effluent containing up to 400 ppm of initial organic carbon concentration (TOC). An initial ratio of Fe(II)/TOC higher than 0.5 guarantees a high removal. It can be seen that most of TOC removal occurs early in the first hour of reaction. After this time, mineralization was very slow, although H2O2 was still present in solution. Indeed it decomposed to form oxygen in inefficient reactions. It is clear that remaining TOC was mainly due to the presence of acetates which are difficult to degrade. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

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

    2018-03-30

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

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

    OpenAIRE

    Niquette , Manon

    2012-01-01

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

  3. Validated electrochemical and chromatographic quantifications of some antibiotic residues in pharmaceutical industrial waste water.

    Science.gov (United States)

    Ibrahim, Heba K; Abdel-Moety, Mona M; Abdel-Gawad, Sherif A; Al-Ghobashy, Medhat A; Kawy, Mohamed Abdel

    2017-03-01

    Realistic implementation of ion selective electrodes (ISEs) into environmental monitoring programs has always been a challenging task. This could be largely attributed to difficulties in validation of ISE assay results. In this study, the electrochemical response of amoxicillin trihydrate (AMX), ciprofloxacin hydrochloride (CPLX), trimethoprim (TMP), and norfloxacin (NFLX) was studied by the fabrication of sensitive membrane electrodes belonging to two types of ISEs, which are polyvinyl chloride (PVC) membrane electrodes and glassy carbon (GC) electrodes. Linear response for the membrane electrodes was in the concentration range of 10 -5 -10 -2  mol/L. For the PVC membrane electrodes, Nernstian slopes of 55.1, 56.5, 56.5, and 54.0 mV/decade were achieved over a pH 4-8 for AMX, CPLX, and NFLX, respectively, and pH 3-6 for TMP. On the other hand, for GC electrodes, Nernstian slopes of 59.1, 58.2, 57.0, and 58.2 mV/decade were achieved over pH 4-8 for AMX, CPLX, and NFLX, respectively, and pH 3-6 for TMP. In addition to assay validation to international industry standards, the fabricated electrodes were also cross-validated relative to conventional separation techniques; high performance liquid chromatography (HPLC), and thin layer chromatography (TLC)-densitometry. The HPLC assay was applied in concentration range of 0.5-10.0 μg/mL, for all target analytes. The TLC-densitometry was adopted over a concentration range of 0.3-1.0 μg/band, for AMX, and 0.1-0.9 μg/band, for CPLX, NFLX, and TMP. The proposed techniques were successfully applied for quantification of the selected drugs either in pure form or waste water samples obtained from pharmaceutical plants. The actual waste water samples were subjected to solid phase extraction (SPE) for pretreatment prior to the application of chromatographic techniques (HPLC and TLC-densitometry). On the other hand, the fabricated electrodes were successfully applied for quantification of the antibiotic residues in actual

  4. Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation

    Science.gov (United States)

    We measured the concentrations of 56 active pharmaceutical ingredients (APIs) and seven metabolites, including 50 prioritized APIs, in 24-hour composite effluent samples collected from 50 very large municipal wastewater treatment plants across the US. Hydrochlorothiazide was foun...

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

    Science.gov (United States)

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

    2017-01-01

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

  6. Drug-disease modeling in the pharmaceutical industry - where mechanistic systems pharmacology and statistical pharmacometrics meet.

    Science.gov (United States)

    Helmlinger, Gabriel; Al-Huniti, Nidal; Aksenov, Sergey; Peskov, Kirill; Hallow, Karen M; Chu, Lulu; Boulton, David; Eriksson, Ulf; Hamrén, Bengt; Lambert, Craig; Masson, Eric; Tomkinson, Helen; Stanski, Donald

    2017-11-15

    Modeling & simulation (M&S) methodologies are established quantitative tools, which have proven to be useful in supporting the research, development (R&D), regulatory approval, and marketing of novel therapeutics. Applications of M&S help design efficient studies and interpret their results in context of all available data and knowledge to enable effective decision-making during the R&D process. In this mini-review, we focus on two sets of modeling approaches: population-based models, which are well-established within the pharmaceutical industry today, and fall under the discipline of clinical pharmacometrics (PMX); and systems dynamics models, which encompass a range of models of (patho-)physiology amenable to pharmacological intervention, of signaling pathways in biology, and of substance distribution in the body (today known as physiologically-based pharmacokinetic models) - which today may be collectively referred to as quantitative systems pharmacology models (QSP). We next describe the convergence - or rather selected integration - of PMX and QSP approaches into 'middle-out' drug-disease models, which retain selected mechanistic aspects, while remaining parsimonious, fit-for-purpose, and able to address variability and the testing of covariates. We further propose development opportunities for drug-disease systems models, to increase their utility and applicability throughout the preclinical and clinical spectrum of pharmaceutical R&D. Copyright © 2017 Elsevier B.V. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Sandeep Kumar Gupta

    2013-01-01

    Full Text Available 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.

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

    Science.gov (United States)

    Song, Chie Hoon; Han, Jeung-Whan

    2016-01-01

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

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

    Science.gov (United States)

    Iñesta, Antonio; Oteo, Luis Angel

    2011-06-01

    The global economic crisis and its impact on public finances in most developed countries are giving rise to cost-containment policies in healthcare systems. Prevailing legislation on medication requires the safety, quality, and efficacy of these products. A few countries include efficiency criteria, primarily for new medication that they wish to include in public financing. The appropriate use of generic and "biosimilar medication" is very important for maintaining the financial equilibrium of the Health Services. The problem in Latin America is that not all multisource products are bioequivalent and not all countries have the resources to conduct bioequivalence studies in vivo. The European Medicines Agency in 2005 adopted guidelines on "biosimilar medicines" and thirteen of them were subsequently approved for general release. Benchmarking of this model by other countries would be important. The influence of the pharmaceutical industry on political and administrative areas is enormous and control is necessary. The pharmaceutical companies claim that they act with corporate social responsibility, therefore, they must ensure this responsibility toward society.

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

    Science.gov (United States)

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

    2007-06-01

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

  11. Biocatalysts for the pharmaceutical industry created by structure-guided directed evolution of stereoselective enzymes.

    Science.gov (United States)

    Li, Guangyue; Wang, Jian-Bo; Reetz, Manfred T

    2018-04-01

    Enzymes have been used for a long time as catalysts in the asymmetric synthesis of chiral intermediates needed in the production of therapeutic drugs. However, this alternative to man-made catalysts has suffered traditionally from distinct limitations, namely the often observed wrong or insufficient enantio- and/or regioselectivity, low activity, narrow substrate range, and insufficient thermostability. With the advent of directed evolution, these problems can be generally solved. The challenge is to develop and apply the most efficient mutagenesis methods which lead to highest-quality mutant libraries requiring minimal screening. Structure-guided saturation mutagenesis and its iterative form have emerged as the method of choice for evolving stereo- and regioselective mutant enzymes needed in the asymmetric synthesis of chiral intermediates. The number of (industrial) applications in the preparation of chiral pharmaceuticals is rapidly increasing. This review features and analyzes typical case studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Application of the Lean Methodology in a company from the pharmaceutical and food industry

    Directory of Open Access Journals (Sweden)

    Juliana Keiko Sagawa

    2016-06-01

    Full Text Available The main goal of Lean Manufacturing is the reduction of waste and consequently the improvement of manufacturing efficiency and quality. This paper presents a case study in a company from the pharmaceutical, health and food industry. The value stream was mapped, aiming to identify waste and the possible ways of reducing it, according to the lean principles. Among the proposed solutions is the implementation of Kanban cards and the implementation of a panel for stock control and production leveling (heijunka. A 70% reduction of the total lead time was estimated as a potential result (from 71 to 19 days. The proposed improvements sought to provide a balance given the trade-off between more flexible production with smaller batches, and the lower total set up time of larger batches.

  13. Supply Network Planning for New Product Market Entry in the Pharmaceutical Industry

    DEFF Research Database (Denmark)

    Hansen, Klaus Reinholdt Nyhuus; Grunow, Martin

    2011-01-01

    uncertainty and the risk of a forced label change and includes solution robustness. While considering limited shelf life of the drug, the supply of packaging material and outsourcing, the objective of our model is to reduce supply chain cost including lost peak sales from delayed market entry....... planning before and during the market entry of the drug after the drug has been approved. Production of the active pharmaceutical ingredient [API] is characterized by long change-over times due to cleaning requirements. Production planning is long term, multiple batches of each drug are produced...... industry, reimbursement negotiations have to be carried out before a drug can be marketed. These negotiations both necessitate time phasing market entries and introduce a series of uncertainties e.g. varying allowed price and awarded subsidy. Also if the label is not approved for marketing, all packaged...

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

    Science.gov (United States)

    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. © 2013 American Society for Veterinary Clinical Pathology.

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

    International Nuclear Information System (INIS)

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

    2014-01-01

    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. -- Highlights: • Seasonal variation revealed a higher spring-summer removal compared to winter time. • Biological process was unable to provide a complete removal for most compounds. • UV-based tertiary treatment did play a complementary removal role for specific PhACs. • Diffuse river contamination and local WWTP contribution to it were observed. • River attenuation capacity is an important factor for removing most of the compounds. -- PhACs integrated WWTP-river data evaluation of coupled biological process and UV tertiary treatment in a WWTP with significant industrial contribution and in the receiving river waters

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    Klaus Lieb

    Full Text Available BACKGROUND: 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. METHOD: 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. RESULTS: 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. CONCLUSIONS: 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

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

    Science.gov (United States)

    2014-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-03-01

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

  20. Leveraging a large scale mammalian pharmacological dataset to prioritize potential environmental hazard of pharmaceuticals

    Science.gov (United States)

    The potential for pharmaceuticals in the environment to cause adverse ecological effects is of increasing concern. Given the thousands of active pharmaceutical ingredients (APIs) which can enter the aquatic environment through various means, a current challenge in aquatic toxicol...

  1. Air temperature gradient in large industrial hall

    Science.gov (United States)

    Karpuk, Michał; Pełech, Aleksander; Przydróżny, Edward; Walaszczyk, Juliusz; Szczęśniak, Sylwia

    2017-11-01

    In the rooms with dominant sensible heat load, volume airflow depends on many factors incl. pre-established temperature difference between exhaust and supply airflow. As the temperature difference is getting higher, airflow volume drops down, consequently, the cost of AHU is reduced. In high industrial halls with air exhaust grids located under the ceiling additional temperature gradient above working zone should be taken into consideration. In this regard, experimental research of the vertical air temperature gradient in high industrial halls were carried out for the case of mixing ventilation system The paper presents the results of air temperature distribution measurements in high technological hall (mechanically ventilated) under significant sensible heat load conditions. The supply airflow was delivered to the hall with the help of the swirl diffusers while exhaust grids were located under the hall ceiling. Basing on the air temperature distribution measurements performed on the seven pre-established levels, air temperature gradient in the area between 2.0 and 7.0 m above the floor was calculated and analysed.

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

    Directory of Open Access Journals (Sweden)

    Anna V Zetterqvist

    Full Text Available 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

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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

  5. Acquiring Pharmaceutical Industry Assets in the UK: 1 + 1 = 1?

    Science.gov (United States)

    Kanavos, Panos; Angelis, Aris

    2014-01-01

    The recent AstraZeneca takeover bid from Pfizer puts pharmaceutical R&D once again on the public agenda. Three pertinent questions are (a) what can be expected from this acquisition, (b) what are the implications for the UK economy and science base, and (c) whether such a deal should go ahead. Although the key driver behind this acquisition would be an improvement in company performance and shareholder value, past evidence suggests that mergers and acquisitions (M&A) of large pharmaceutical companies imply a neutral net effect on productivity, if not a decline, with employment decreasing and R&D spend following a similar trend. Similarities between the two companies include dropping sales; however, relative to its size, AstraZeneca has a more promising R&D pipeline, especially in therapeutic areas where Pfizer's strength is currently limited (e.g. oncology). Ensuring a portfolio diversification would make Pfizer's takeover proposal a knight's one, but history points towards a knave-like behavior.

  6. Reactive power compensation and loss reduction in large industrial enterprises

    Energy Technology Data Exchange (ETDEWEB)

    Jovanovic, S; Gajic, B; Mijailovic, S [Institute Nikola Tesla, Beograd (Yugoslavia)

    1991-12-01

    This paper considers the reactive power compensation and the active power and energy loss reduction of large radial power networks in the Serbian mine and smelting industry. It gives an efficient optimization procedure for positioning and sizing capacitors in large industrial systems integrated with a simple network analysis method. (Author).

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

    Science.gov (United States)

    Scott, J. Blake

    2009-01-01

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

  8. New product testing and the utilization of user expertise: Evidence from the Pharmaceutical industry

    DEFF Research Database (Denmark)

    Smed, Marie; Salomo, Søren; Schultz, Carsten

    2012-01-01

    A significant and often neglected obstacle in new product development is the testing and approval process in the late stages of development. The testing process has primarily been observed as an in-house decision process, however, in many industries products undergo extensive testing before marke....... Further, with a dispersed user network a positive effect is observed on the mean to communicate directly as issues occur. The effect of virtual communication is therefore stronger than traditional face-to-face interaction patterns.......A significant and often neglected obstacle in new product development is the testing and approval process in the late stages of development. The testing process has primarily been observed as an in-house decision process, however, in many industries products undergo extensive testing before market...... the knowledge generated and shared by medical sites and Pharmaceutical producers in late stage product development. The results show, that information regarding usage patterns and product related services are more difficult to transfer between user and developer, than issues directly related to the product...

  9. Calibration and qualification of equipment in the pharmaceutical industry: emphasis on radiopharmaceuticals production

    International Nuclear Information System (INIS)

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

    2011-01-01

    The calibration and qualification of equipment are listed items in RDC number 17 of 2010 which refers about the Good Manufacturing Practice (GMP) of medicaments and RDC number 63 of 2009 which refers about GMP of Radiopharmaceuticals. Both are essential requirements since they are involved in process control to attend the regulatory criteria and are a key part of the validation process. The aim of this work is presenting the importance of calibration and qualification, and the routine use of equipment and facilities in industrial scale production of radiopharmaceuticals in the IPEN/CNEN. The radiopharmacy of IPEN is a pharmaceutical industry that produces radiopharmaceuticals for diagnosis and therapy. It was the pioneer institute in production of radioisotopes and radiopharmaceuticals in Brazil. Currently, 38 products are distributed to the nuclear medicine centers, including primary radioisotopes, labeled molecules and lyophilized reagents for labeling with technetium-99m. To fulfill the GMP requirements for quality assurance of products, several factors must be considered including infrastructure, equipment and raw materials beyond, obviously, the whole production process should be controlled until the release of the final product. Therefore, the calibration and verification of equipment, instruments and other appliances used in the production and quality control should be performed. A program of calibration, qualification and requalification of equipment used in production and quality control of radiopharmaceuticals is necessary for the validation of production processes and analytical methods, and should be established for quality assurance of produced radiopharmaceuticals. (author)

  10. Calibration and qualification of equipment in the pharmaceutical industry: emphasis on radiopharmaceuticals production

    Energy Technology Data Exchange (ETDEWEB)

    Melero, Laura T.U.H.; Silva, Katia S. da S.; Zanette, Camila; Araujo, Elaine B. de; Mengatti, Jair [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

    2011-07-01

    The calibration and qualification of equipment are listed items in RDC number 17 of 2010 which refers about the Good Manufacturing Practice (GMP) of medicaments and RDC number 63 of 2009 which refers about GMP of Radiopharmaceuticals. Both are essential requirements since they are involved in process control to attend the regulatory criteria and are a key part of the validation process. The aim of this work is presenting the importance of calibration and qualification, and the routine use of equipment and facilities in industrial scale production of radiopharmaceuticals in the IPEN/CNEN. The radiopharmacy of IPEN is a pharmaceutical industry that produces radiopharmaceuticals for diagnosis and therapy. It was the pioneer institute in production of radioisotopes and radiopharmaceuticals in Brazil. Currently, 38 products are distributed to the nuclear medicine centers, including primary radioisotopes, labeled molecules and lyophilized reagents for labeling with technetium-99m. To fulfill the GMP requirements for quality assurance of products, several factors must be considered including infrastructure, equipment and raw materials beyond, obviously, the whole production process should be controlled until the release of the final product. Therefore, the calibration and verification of equipment, instruments and other appliances used in the production and quality control should be performed. A program of calibration, qualification and requalification of equipment used in production and quality control of radiopharmaceuticals is necessary for the validation of production processes and analytical methods, and should be established for quality assurance of produced radiopharmaceuticals. (author)

  11. Silo effect a prominence factor to decrease efficiency of pharmaceutical industry.

    Science.gov (United States)

    Vatanpour, Hossein; Khorramnia, Atoosa; Forutan, Naghmeh

    2013-01-01

    To be sure, all the industries try to be involved in globalization with a constant trend to find out ways to increase productivity across different functions within an organization to maintain competitive advantage world. Pharmaceutical industries are not exceptional and further are based on fragmentation. So these kind of companies need to cope with several barriers such as silo mentality that may affect efficiency of their business activity. Due to eliminate a part of resources such as raw materials, new molecule developed, financial and human resources and so on, companies can gradually loss their competitive potentials in the market and increase their expenses. Furthermore, to avoid any business disturbances in financially connected companies due to silo effect, they should arrange their management to integrated organization form. Otherwise, actions taken by one business member of the chain can influence the profitability of all the other members in the chain. That is why recently supply chain has generated much interest in many business units. In this paper, it has been tried to investigate the different aspects of silo effect which can affect integrate supply chain. Finally, a fluent communication, high level of information exchange, fragmentation management, cross-functional control in a supply chain management format are needed to reduce or control silo effect within entire chain of the holding company by Supply chain management.

  12. THE EFFECT OF TRAINING IN THE IMPROVEMENT OF EMPLOYEE EFFICIENCY IN PHARMACEUTICAL INDUSTRY AND AN APPLICATION

    Directory of Open Access Journals (Sweden)

    Sinem AYDOĞDU

    2013-01-01

    Full Text Available Businesses faces with important and rapid changes. This rapid change in the business environment forces the organizations to change their operations and structures. Adopting these changes fast and contionus renewal of both employees and organizations help organizations reach the set goals and survive in the competitive market. To be accomplished in competition, companies need well trained and well developed employees from front employees to the top level managers in the executive suite. Moreover, training process must gain continuity. Especially, in Pharmaceutical Industry, due to the fast and rapid changes and improvements concerning the regulations and procedures of Ministery of Health, guidelines such as GMP (Good Manufacturing Practises, GLP (Good Laboratory Practises, GDP (Good Documentation Practises etc. employees who are working should be trained and updated about the current knowledge to increase the efficiency in the organization. Vice versa, organizations can not raise their competition power in order to exist and develop themselves. To sum up, globalization, fast changes in regulations and procedures and also technological shifts lead to changes even in organizations. In order to cope with these changes, companies need to train their employees. The main purpose of this study is to investigate the effect of training on employee efficiency. Research is carried out with 74 employees from a pharmaceutical company in İstanbul, Turkey. The results of the study support the hypotheses. There’s a significant difference between white collar and blue collar employees on the idea of efficiency of training in the area of career development, area of productivity, professional growth and customer satisfaction.

  13. Value Frameworks in Oncology: Comparative Analysis and Implications to the Pharmaceutical Industry.

    Science.gov (United States)

    Slomiany, Mark; Madhavan, Priya; Kuehn, Michael; Richardson, Sasha

    2017-07-01

    As the cost of oncology care continues to rise, composite value models that variably capture the diverse concerns of patients, physicians, payers, policymakers, and the pharmaceutical industry have begun to take shape. To review the capabilities and limitations of 5 of the most notable value frameworks in oncology that have emerged in recent years and to compare their relative value and application among the intended stakeholders. We compared the methodology of the American Society of Clinical Oncology (ASCO) Value Framework (version 2.0), the National Comprehensive Cancer Network Evidence Blocks, Memorial Sloan Kettering Cancer Center DrugAbacus, the Institute for Clinical and Economic Review Value Assessment Framework, and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale, using a side-by-side comparative approach in terms of the input, scoring methodology, and output of each framework. In addition, we gleaned stakeholder insights about these frameworks and their potential real-world applications through dialogues with physicians and payers, as well as through secondary research and an aggregate analysis of previously published survey results. The analysis identified several framework-specific themes in their respective focus on clinical trial elements, breadth of evidence, evidence weighting, scoring methodology, and value to stakeholders. Our dialogues with physicians and our aggregate analysis of previous surveys revealed a varying level of awareness of, and use of, each of the value frameworks in clinical practice. For example, although the ASCO Value Framework appears nascent in clinical practice, physicians believe that the frameworks will be more useful in practice in the future as they become more established and as their outputs are more widely accepted. Along with patients and payers, who bear the burden of treatment costs, physicians and policymakers have waded into the discussion of defining value in oncology care, as well

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

    Science.gov (United States)

    Emami, Hassan; Radfar, Reza

    2017-01-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

  16. Efficiency and Ranking of Indian Pharmaceutical Industry: Does Type of Ownership Matter?

    Directory of Open Access Journals (Sweden)

    Varun MAHAJAN

    2014-11-01

    Full Text Available This paper measures the technical efficiency, super-efficiency, slacks, and input/output targets for large Indian pharmaceutical firms according to ownership by applying Data Envelopment Analysis (DEA approach. The paper uses raw material, salaries & wages, advertisement & marketing and capital usage cost as input variables and net sales revenue as output variable. The super-efficiency model is applied to rank firms on the basis of efficiency scores. The paper finds that mean overall technical efficiency scores of Private Indian and Private Foreign are higher than Group-owned firms, suggesting that type of ownership affects the performance of a given firm. Further, foreign firms were found to have minimum slacks in inputs, evidently owing to their superior technology, better engineering skills and managerial practices. The study suggests that the inputs, such as, advertisement & marketing expenditure, and also the usage of labour and capital are required to be utilized far more productively in order to improve efficiency.

  17. Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface.

    Science.gov (United States)

    Haidar Ahmad, Imad A; Blasko, Andrei

    2017-08-11

    The aim of this work is to identify the parameters that affect the recovery of pharmaceutical residues from the surface of stainless steel coupons. A series of factors were assessed, including drug product spike levels, spiking procedure, drug-excipient ratios, analyst-to-analyst variability, intraday variability, and cleaning procedure of the coupons. The lack of a well-defined procedure that consistently cleaned the coupon surface was identified as the major contributor to low and variable recoveries. Assessment of cleaning the surface of the coupons with clean-in-place solutions (CIP) gave high recovery (>90%) and reproducible results (Srel≤4%) regardless of the conditions that were assessed previously. The approach was successfully applied for cleaning verification of small molecules (MW <1,000 Da) as well as large biomolecules (MW up to 50,000 Da).

  18. The World Health Organization and the Pharmaceutical Industry. Common areas of interest and differing views.

    Science.gov (United States)

    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

  19. Determining supply chain management trends in the pharmaceutical industry / Mokgokong ElizabethTsoku

    OpenAIRE

    Tsoku, Mokgokong Elizabeth

    2014-01-01

    For quality service, business management is continually evolving. This also applies to pharmaceutical business management from manufacturing to distribution and retail pharmacies. The main problem being faced is to work on the demand and supply challenges that are being faced by the pharmaceutical businesses and to build and optimize supply chain management in pharmaceutical business in South Africa. The main objective of this study sets to evaluate whether supply chain tren...

  20. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

    Science.gov (United States)

    Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

    2017-12-05

    To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track

  1. Animals on drugs: understanding the role of pharmaceutical companies in the animal-industrial complex.

    Science.gov (United States)

    Twine, Richard

    2013-12-01

    In this paper I revisit previous critiques that I have made of much, though by no means all, bioethical discourse. These pertain to faithfulness to dualistic ontology, a taken-for-granted normative anthropocentrism, and the exclusion of a consideration of how political economy shapes the conditions for bioethical discourse (Twine Medicine, Health Care and Philosophy 8(3):285-295, 2005; International Journal of Sociology of Agriculture and Food 16(3):1-18, 2007, 2010). Part of my argument around bioethical dualist ontology is to critique the assumption of a division between the "medical" (human) and "agricultural" (nonhuman) and to show various ways in which they are interrelated. I deepen this analysis with a focus on transnational pharmaceutical companies, with specific attention to their role in enhancing agricultural production through animal drug administration. I employ the topical case of antibiotics in order to speak to current debates in not only the interdisciplinary field of bioethics but also that of animal studies. More generally, the animal-industrial complex (Twine Journal for Critical Animal Studies 10(1):12-39, 2012) is underlined as a highly relevant bioethical object that deserves more conceptual and empirical attention.

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

    Science.gov (United States)

    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

  3. Impact of Corporate Governance on Research and Development Investment in the Pharmaceutical Industry in South Korea.

    Science.gov (United States)

    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 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.

  4. Assessment of food processing and pharmaceutical industrial wastes as potential biosorbents: a review.

    Science.gov (United States)

    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.

  5. Multiplicity: discussion points from the Statisticians in the Pharmaceutical Industry multiplicity expert group.

    Science.gov (United States)

    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.

  6. Secondary patents in the pharmaceutical industry: missing the wood for the trees?

    Science.gov (United States)

    Kiran, Saritha; Kulkarni, Mohan

    2018-03-01

    The critics of the Innovator pharmaceutical industry allege that secondary patents are trivial modifications over the primary patent, which extend its term and delay the entry of the generics in the market place. The protagonists regard secondary patents a result of continuous research and development (R&D), which help them introduce and protect new, differentiated products. Areas covered: The areas covered are Product life cycle management (PLCM), Drug approval process, Orange book (OB) listed patents, US patent data. Expert opinion: Our analysis of the patents and products of four innovators viz., AstraZeneca, Takeda, Eisai and Wyeth in the field of proton pump inhibitors (PPI's) and Merck and Pfizer in the field of Statins shows that secondary patents help innovators sustain competition against other innovators in the specific product segment. The number of secondary patents listed in OB per NCE depends on the innovators interest in exploiting the NCE, the success of R & D effort and product lifecycle management strategy in the wake of market competition. Market entry decisions of innovators are strategic rather than a mere fallout of the secondary patents granted. Entry of another innovator is more unpredictable and hurts the first entrant more vis a vis the entry of generics who can enter the market when the patents protecting a product are no more enforceable, and hence more predictable. Generic entry in the field of PPI's shows that the term of the primary patent is not extended by the secondary patents.

  7. A survey of the effects of brand value on customer satisfaction in pharmaceutical and biological industries

    Directory of Open Access Journals (Sweden)

    Alipour, A.

    2016-07-01

    Full Text Available . The purpose of this study was to describe how companies in pharmaceutical and biological sectors can ensure their position in different markets by relying on sustainable, competitive advantages, resulting from the use of a well-defined marketing model with particular emphasis on brand improvement. As competition becomes more intense among companies and phenomena such as global marketing grow in importance, domestic industries in each country become obliged to improve their competitive advantages in order to survive from a marketing perspective. Customer satisfaction is among factors which could lead to the success and profitability of a company. The present research examined the relationship between brand value and customer behavioral intention. Accordingly, 80 questionnaires were distributed among customers, selected through random sampling in Tehran, Iran. The obtained data were analyzed by SPSS. Based on descriptive statistics, two aspects of customer behavioral intention included “product introduction” and “repeat purchase”, while two aspects of brand equity were “brand awareness” and “product introduction”. The research findings showed that factors such as “brand awareness” and “brand loyalty” directly affect customer behavioral intention and satisfaction.

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

    Science.gov (United States)

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

    2016-01-01

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

  9. Bulgarian electricity market and the large-scale industrial customers

    International Nuclear Information System (INIS)

    Popov, P.; Kanev, K.; Dyankov, M.; Minkov, N.

    2003-01-01

    The paper focuses on a brief overview of the Bulgarian Electricity Market Design and steps toward its development, as well as on preliminary analyses for market opening and influence of large industrial customers to system and market operation. (author)

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

    Directory of Open Access Journals (Sweden)

    Marinković Valentina D.

    2013-01-01

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

  11. Management of effluents and waste from pharmaceutical industry in Minas Gerais, Brazil

    Directory of Open Access Journals (Sweden)

    Eleonora Deschamps

    2012-12-01

    Full Text Available Today the management of solid waste and wastewater is a major concern for humanity. In the last decade, traces of pharmaceuticals have been reported in the water cycle and have raised concerns among regulators, water suppliers and the public regarding the potential risks to human health. This study evaluated solid waste management in the state of Minas Gerais and concluded that the main fate of hazardous waste has been incineration, while the non-hazardous waste has been recycled or sent to landfills. However, complaints to the Environmental Agency - FEAM have indicated that a significant number of companies just send their hazardous wastes to landfills or even to garbage dumps, thus highlighting the urgent need for adequate waste management in Minas Gerais. Most of the pharmaceutical companies in Minas Gerais use conventional wastewater treatment. Mass spectrometry with electrospray ionization (ESI-MS showed that the treatment routes adopted by the two 2 selected pharmaceutical industries were not effective enough since residues and degradation products of antibiotics were detected. The physicochemical analysis of the effluents showed variability in their characteristics, which may influence their treatability. The degradation assay with Fenton's reagent stood out as a promising route in achieving a higher removal capacity compared to the conventional treatment. This study contributes to enhancing our knowledge of the management of wastewater as well as of solid waste from the pharmaceutical industry in Minas Gerais and points out the need for further research.Atualmente, a gestão de resíduos sólidos e águas residuais é uma grande preocupação para a humanidade. Na ultima década, a detecção de traços de medicamentos no ciclo da água tem sido reportada e tem gerado preocupação entre os agentes reguladores, fornecedores de água e público devido os riscos potenciais para a saúde humana. As empresas farmacêuticas, em Minas Gerais

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

    Directory of Open Access Journals (Sweden)

    Raúl Rodríguez Nozal

    2017-06-01

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

  13. Perception and application of the concept “quality by design” (QbD) by the pharmaceutical industry in Portugal

    OpenAIRE

    Garcia, Ana Cristina; Fernandes, Paula O.; Santos, Andreia

    2014-01-01

    The Quality by Design (QbD) paradigm states that in order to ensure predefined product quality, improve manufacturing quality performance, and serve customers’ needs one must fully understand the processes behind it. With the purpose of assessing the perception of the pharmaceutical industry in Portugal about the usefulness of a strategy for development, production optimization and control/quality management according to the QbD concept and its level of implementation, we conducted a survey a...

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

    Directory of Open Access Journals (Sweden)

    Evert A. Jiménez-Cotes

    2015-01-01

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

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

    Science.gov (United States)

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

    2016-01-07

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

  16. Implementing US-style anti-fraud laws in the Australian pharmaceutical and health care industries.

    Science.gov (United States)

    Faunce, Thomas A; Urbas, Gregor; Skillen, Lesley

    2011-05-02

    This article critically analyses the prospects for introducing United States anti-fraud (or anti-false claims) laws in the Australian health care setting. Australian governments spend billions of dollars each year on medicines and health care. A recent report estimates that the money lost to corporate fraud in Australia is growing at an annual rate of 7%, but that only a third of the losses are currently being detected. In the US, qui tam provisions - the component of anti-fraud or anti-false claims laws involving payments to whistleblowers - have been particularly successful in providing critical evidence allowing public prosecutors to recover damages for fraud and false claims made by corporations in relation to federal and state health care programs. The US continues to strengthen such anti-fraud measures and to successfully apply them to a widening range of areas involving large public investment. Australia still suffers from the absence of any comprehensive scheme that not only allows treble damages recovery for fraud on the public purse, but crucially supports such actions by providing financial encouragement for whistleblowing corporate insiders to expose evidence of fraud. Potential areas of application could include direct and indirect government expenditure on health care service provision, pharmaceuticals, medical devices, defence, carbon emissions compensation and tobacco-related illness. The creation in Australia of an equivalent to US anti-false claims legislation should be a policy priority, particularly in a period of financial stringency.

  17. The Importance of Management Control in Monitoring the Pharmaceutical Industry Performance for Competitive Advantage

    Directory of Open Access Journals (Sweden)

    Florinel Marian SGARDEA

    2011-12-01

    Full Text Available Management control and thus managerial accounting will adapt to the requirements of market economy in terms of knowledge. Another thought other action. The sustainability of a business depends on how we use resources but also can correct measurement of performance of a project or activity. The distinction between ‘traditional’ and ‘innovative’ management accounting practices can be illustrated by reference to cost control techniques. Traditionally, management accountants’ principal technique was variance analysis, which is a systematic approach to the comparison of the actual (real costs and budgeted costs of the raw materials and labor used during a production period. In this paper we wanted to show that the new management control procedures are part of knowledge management. Today is important for pharmaceutical companies to produce new products of advanced research results. This means that, for large companies, research expenditure budget is generous. More projects need to be monitored, evaluated and presented to the Board of Directors. What indicators will be kept for financial analysis? How prospective financial situation will look in five years? What will be the level of risk accepted by investors?

  18. Pengaruh Pengendalian Intern Terhadap Efektivitas Target Produksi PT. Lucas Djaja Pharmaceutical Industry Bandung Jawa Barat

    Directory of Open Access Journals (Sweden)

    Bulan Tati Fitria

    2013-04-01

    Full Text Available The achievement of operational targets is expected by each organization / company. Due to the achievement of the target, it can be judged that the performance of the company very well. Therefore, if it is not achieved it is necessary to study the factors that influence it. For then do repairs on these factors. In the achievement of the target company, it takes a process associated with the target to be achieved. In order to achieve maximum results and effective it is necessary to an adequate internal control structure, which aims to regulate the operational steps the company to run an organized and effective.The study was conducted at PT. Lucas Djaja Pharmaceutical Industry, located in Bandung, is to know how the implementation of internal controls and how they affect the effectiveness of the production targets, in particular the production of injection of 1 (one milliliter. This research used descriptive analysis with research techniques such as interviews, observations, questionnaires and literature study. Based on the results of this study concluded that the implementation of internal control at PT. Lucas Djaja is sufficient, this can be seen from the data obtained from the questionnaire filled out by the respondents, which is related to the control environment, risk assessment, information and communication, control activities, and monitoring. Meanwhile that of the effectiveness of the production target is still this can be seen from the data obtained from the questionnaire filled out by the respondents, ranging from productivity, quality, efficiency, flexibility, excellence, development, and satisfaction. And the obtained results of the research stating that the internal control effect on effectiveness production targets with determination coefficient of 56.01% and the remaining 43.99% influenced by other factors.

  19. Novel marine actinobacteria from emerald Andaman & Nicobar Islands: a prospective source for industrial and pharmaceutical byproducts.

    Science.gov (United States)

    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. Prioritization of pharmaceuticals for potential environmental hazard through leveraging a large scale mammalian pharmacological dataset

    Science.gov (United States)

    To proceed in the investigation of potential effects of thousands of active pharmaceutical ingredients (API) which may enter the aquatic environment, a cohesive research strategy, specifically a prioritization is paramount. API are biologically active, with specific physiologica...

  1. Primary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study.

    Directory of Open Access Journals (Sweden)

    Annemarije L Kruis

    Full Text Available BACKGROUND: Guideline recommendations for chronic obstructive pulmonary disease (COPD are based on the results of large pharmaceutically-sponsored COPD studies (LPCS. There is a paucity of data on disease characteristics at the primary care level, while the majority of COPD patients are treated in primary care. OBJECTIVE: We aimed to evaluate the external validity of six LPCS (ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD on which current guidelines are based, in relation to primary care COPD patients, in order to inform future clinical practice guidelines and trials. METHODS: Baseline data of seven primary care databases (n=3508 from Europe were compared to baseline data of the LPCS. In addition, we examined the proportion of primary care patients eligible to participate in the LPCS, based on inclusion criteria. RESULTS: Overall, patients included in the LPCS were younger (mean difference (MD-2.4; p=0.03, predominantly male (MD 12.4; p=0.1 with worse lung function (FEV1% MD -16.4; p<0.01 and worse quality of life scores (SGRQ MD 15.8; p=0.01. There were large differences in GOLD stage distribution compared to primary care patients. Mean exacerbation rates were higher in LPCS, with an overrepresentation of patients with ≥ 1 and ≥ 2 exacerbations, although results were not statistically significant. Our findings add to the literature, as we revealed hitherto unknown GOLD I exacerbation characteristics, showing 34% of mild patients had ≥ 1 exacerbations per year and 12% had ≥ 2 exacerbations per year. The proportion of primary care patients eligible for inclusion in LPCS ranged from 17% (TRISTAN to 42% (ECLIPSE, UPLIFT. CONCLUSION: Primary care COPD patients stand out from patients enrolled in LPCS in terms of gender, lung function, quality of life and exacerbations. More research is needed to determine the effect of pharmacological treatment in mild to moderate patients. We encourage future guideline makers to involve primary care

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

    Directory of Open Access Journals (Sweden)

    Rizwan Raheem Ahmed

    2018-05-01

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

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

    Science.gov (United States)

    Shimura, Hirohisa; Masuda, Sachiko; Kimura, Hiromichi

    2014-02-01

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

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

    Directory of Open Access Journals (Sweden)

    Tommy C. Efrata

    2016-02-01

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

  5. The FDA guidance for industry on PROs: the point of view of a pharmaceutical company.

    Science.gov (United States)

    Arpinelli, Fabio; Bamfi, Francesco

    2006-10-31

    The importance of the patients point of view on their health status is widely recognised. Patient-reported outcomes is a broad term encompassing a large variety of different health data reported by patients, as symptoms, functional status, Quality of Life and Health-Related Quality of Life. Measurements of Health-Related Quality of Life have been developed during many years of researches, and a lot of validated questionnaires exist. However, few attempts have been made to standardise the evaluation of instruments characteristics, no recommendations are made about interpretation on Health-Related Quality of Life results, especially regarding the clinical significance of a change leading a therapeutic approach. Moreover, the true value of Health-Related Quality of Life evaluations in clinical trials has not yet been completely defined. An important step towards a more structured and frequent use of Patient-Reported Outcomes in drug development is represented by the FDA Guidance, issued on February 2006. In our paper we aim to report some considerations on this Guidance. Our comments focus especially on the characteristics of instruments to use, the Minimal Important Difference, and the methods to calculate it. Furthermore, we present the advantages and opportunities of using the Patient-Reported Outcomes in drug development, as seen by a pharmaceutical company. The Patient-Reported Outcomes can provide additional data to make a drug more competitive than others of the same pharmacological class, and a well demonstrated positive impact on the patient' health status and daily life might allow a higher price and/or the inclusion in a reimbursement list. Applying extensively the FDA Guidance in the next trials could lead to a wider culture of subjective measurement, and to a greater consideration for the patient's opinions on his/her care. Moreover, prescribing doctors and payers could benefit from subjective information to better define the value of drugs.

  6. Basic pharmaceutical technology

    OpenAIRE

    Angelovska, Bistra; Drakalska, Elena

    2017-01-01

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

  7. The politics and strategy of industry self-regulation: the pharmaceutical industry's principles for ethical direct-to-consumer advertising as a deceptive blocking strategy.

    Science.gov (United States)

    Arnold, Denis G; Oakley, James L

    2013-06-01

    As the pharmaceutical industry lobbies European regulators to permit direct-to-consumer advertising (DTCA) of prescription drugs in the European Union, we found that five leading companies violated industry-developed and -promulgated standards for ethical advertising in the United States. Utilizing multiple data sources and methods, we demonstrate a consistent failure by companies that market erectile dysfunction drugs to comply with the industry's guiding principles for ethical DTCA over a four-year period despite pledges of compliance by company leaders. Noncompliance resulted in children being exposed to sexually themed promotional messages more than 100 billion times. We argue that the guidelines are a coordinated effort by the industry to prevent unwanted federal regulation, and we introduce the concept of a blocking strategy to explain company behavior and to advance theoretical understanding of firms' public affairs strategies. We recommend policy responses to prevent deceptive practices, protect children from adult content, and promote genuine health care education.

  8. Credence goods and market power: an econometric study on the Brazilian pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Eduardo P. S. Fiuza

    2003-12-01

    Full Text Available Bearing in mind the market failures pointed out by the economic literature and following the international empirical evidence, and based on original micro data of the Brazilian pharmaceutical industry in the late 1990s, this article attempts to relate empirically drug prices in Brazil to some explaining variables. We find that, similarly to previous U.S. estimations, leading branded drugs accommodated share growth of the followers, turning towards a more inelastic market segment and raising their prices. On followers, in turn, a fall of the concentration index in a market had ambiguous effects: if due to reduced leader power, followers raised their relative prices; if due to a tougher competition within the fringe, their relative prices tended to go down.No presente artigo procuramos, tendo em mente as imperfeições de mercado apontadas pela literatura e pela experiência internacional, e com base em dados originais da indústria farmacêutica, relacionar empiricamente o preço de medicamentos no Brasil com algumas variáveis explicativas. Encontramos que, consoante com estimações anteriores da experiência norte-americana, os medicamentos líderes no Brasil, antes da lei que instituiu o medicamento genérico, acomodavam o avanço de produtos similares (do mesmo princípio ativo, porém sem o teste de bioequivalência e se recolhiam a segmentos inelásticos do mercado, elevando seus preços. Os similares, ao contrário, ao perderem mercado, reduziam seus preços em relação ao líder, de modo que uma redução no índice de concentração do mercado total de um princípio ativo tem efeitos ambíguos sobre seus preços, dependendo se a causa é uma queda da participação do líder ou um rearranjo dentre os seguidores.

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

    Science.gov (United States)

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

    2004-06-01

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

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

    NARCIS (Netherlands)

    Brown, P.; Calnan, M.

    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

  11. 76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2011-12-02

    ... of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate classification of co-crystal solid-state forms. This draft...

  12. Transparency in the pharmaceutical industry - A cost accounting approach to the prices of drugs

    NARCIS (Netherlands)

    Broekhof, Martijn

    2002-01-01

    The WTO TRIPS agreement grants pharmaceutical companies patent rights on new innovative drugs. Patents give these companies the opportunity to charge higher prices for their drugs in order to recover their R&D expenses. For developing countries this is one of the reasons why people in developing

  13. Health technology assessment of medicines in Greece: pharmaceutical industry executives' views.

    Science.gov (United States)

    Armataki, Eleni; Karampli, Eleftheria; Kyriopoulos, John; Pavi, Elpida

    2014-04-01

    The aim of this study was to investigate originator pharmaceutical companies' practices in relation to health technology assessment (HTA) and the views and perceptions of their executives on the importance of HTA in pricing and reimbursement of medicines in Greece. A qualitative study was performed, using individual semi-structured interviews based on an interview schedule with open-ended questions. The target population was market access departments' executives of originator pharmaceutical companies. Our target sample consisted of sixteen executives, of whom ten agreed to participate. Saturation point was reached after eight interviews. Data were audio recorded, transcribed verbatim, and analyzed using content analysis. Participants considered HTA as a very important complementary tool for decision making in health policy, particularly in the field of pharmaceuticals and medical devices. They believed that, in Greece, HTA could be institutionalized for the reimbursement mechanism of medicines under certain conditions relating to current health policy-making attitudes and conditions pertaining in the country. They considered that there are many constraints which must be overcome as well as opportunities to be exploited. Decisions in pharmaceutical policy should be scientifically substantiated and HTA should be institutionalized primarily for reimbursement decisions. Development of guidelines for conducting pharmaco-economic evaluation, change in health policy goals, recording of cost and epidemiological data, and broader participation of all stakeholders in HTA decision-making processes are suggested as prerequisites for a successful implementation of HTA in Greece.

  14. The simple economics of risk-sharing agreements between the NHS and the pharmaceutical industry.

    Science.gov (United States)

    Barros, Pedro Pita

    2011-04-01

    The introduction of new (and expensive) pharmaceutical products is one of the major challenges for health systems. The search for new institutional arrangements is natural. The use of the so-called risk-sharing agreements is one example. Recent discussions have somewhat neglected the economic fundamentals underlying risk-sharing agreements. We argue here that risk-sharing agreements, although attractive due to the principle of paying by results, also entail risks. Too many patients may be put under treatment. Prices are likely to be adjusted upward, in anticipation of future risk-sharing agreements between the pharmaceutical company and the third-party payer. An available instrument is a verification cost per patient treated, which allows obtaining the first-best allocation of patients to the new treatment, under the agreement. Overall, the welfare effects of risk-sharing agreements are ambiguous, and caution is urged regarding their use. Copyright © 2010 John Wiley & Sons, Ltd.

  15. AN OVERVIEW OF PHARMACEUTICAL PROCESS VALIDATION AND PROCESS CONTROL VARIABLES OF TABLETS MANUFACTURING PROCESSES IN INDUSTRY

    OpenAIRE

    Mahesh B. Wazade*, Sheelpriya R. Walde and Abhay M. Ittadwar

    2012-01-01

    Validation is an integral part of quality assurance; the product quality is derived from careful attention to a number of factors including selection of quality parts and materials, adequate product and manufacturing process design, control of the process variables, in-process and end-product testing. Recently validation has become one of the pharmaceutical industry’s most recognized and discussed subjects. It is a critical success factor in product approval and ongoing commercialization, fac...

  16. Managing Risk to the Patient: Recoding Quality Risk Management for the Pharmaceutical and Biopharmaceutical Industries

    OpenAIRE

    Waldron, Kelly

    2017-01-01

    This thesis explores the application of quality risk management (QRM) in pharmaceutical and biopharmaceutical companies and its effectiveness at managing risk to the patient. The objective of the research described in this thesis was to characterize a maturity state of QRM implementation in which the patient is adequately protected from the risks associated with medicinal products of inadequate quality. The research was conducted over three phases: first, to determine whether patients are bet...

  17. The impact of human capital outsourcing on human capital management practices in Karachi pharmaceutical industry

    OpenAIRE

    Rana, Tariq Mehmood; Syed, Qamar Ali Zaidi; Muhmmad, Sajid; Herani, Gobind M.

    2011-01-01

    Purpose: The aim of this research is to examine relationship between Human Capital Management (HRM) and Human Resource (HR) Outsourcing in the Pharmaceutical sector. The specific objective is to find out that how important is HRM for an Organization to perform its operations more efficiently, and at what level Human Resource Outsourcing is affecting it. Literature review: Literature review shows that HR outsourcing has positive impact on HRM for an Organization to perform its operations more ...

  18. The Determinants of Research and Development Investment in the Pharmaceutical Industry: Focus on Financial Structures

    OpenAIRE

    Lee, Munjae; Choi, Mankyu

    2015-01-01

    Objectives This study analyzes the influence of the financial structure of pharmaceutical companies on R&D investment to create a next-generation profit source or develop relatively cost-effective drugs to maximize enterprise value. 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 (KLCA), and data related to stock price is extracted from ...

  19. The Effect of Transformational Leadership Behavior on Organizational Culture: An Application in Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Sinem Aydogdu

    2011-01-01

    Full Text Available In this study, conducted on 96 employees from production sector in a pharmaceutical company, the effect of transformational leadership behavior on organizational culture is investigated to determine statistically significant relations. The results of the study support the hypotheses. Transformational leadership behavior has a positive and significant correlation between the components of organizational culture such as long / short term orientation, masculinity / feminity, power distance, individualism / collectivisim and uncertainity avoidance.

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

    OpenAIRE

    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 explo...

  1. Globalisation and Its Impact on Competitiveness: the Case of the British and German Pharmaceutical Industry

    OpenAIRE

    Christel Lane; Jocelyn Probert

    2003-01-01

    This paper assesses the degree of financial and economic globalisation of British and German pharmaceutical companies during 1990 and 2001 and explores the changing balance between globalisation and national embeddedness. It tries to explain both the much lower degree of globalisation of German as compared to British companies in 1990, as well as their catching up at the beginning of the 21st century. The paper suggests that the lesser degree of globalisation of German firms during most of th...

  2. Occurrence of antibiotics in pharmaceutical industrial wastewater, wastewater treatment plant and sea waters in Tunisia.

    Science.gov (United States)

    Tahrani, Leyla; Van Loco, Joris; Ben Mansour, Hedi; Reyns, Tim

    2016-04-01

    Antibiotics are among the most commonly used group of pharmaceuticals in human medicine. They can therefore reach surface and groundwater bodies through different routes, such as wastewater treatment plant effluents, surface runoff, or infiltration of water used for agricultural purposes. It is well known that antibiotics pose a significant risk to environmental and human health, even at low concentrations. The aim of the present study was to evaluate the presence of aminoglycosides and phenicol antibiotics in municipal wastewaters, sea water and pharmaceutical effluents in Tunisia. All analysed water samples contained detectable levels of aminoglycoside and phenicol antibiotics. The highest concentrations in wastewater influents were observed for neomycin and kanamycin B (16.4 ng mL(-1) and 7.5 ng mL(-1), respectively). Chloramphenicol was found in wastewater influents up to 3 ng mL(-1). It was observed that the waste water treatment plants were not efficient in completely removing these antibiotics. Chloramphenicol and florfenicol were found in sea water samples near aquaculture sites at levels up to, respectively, 15.6 ng mL(-1) and 18.4 ng mL(-1). Also aminoglycoside antibiotics were found near aquaculture sites with the highest concentration of 3.4 ng mL(-1) for streptomycin. In pharmaceutical effluents, only gentamycin was found at concentrations up to 19 ng mL(-1) over a sampling period of four months.

  3. Impacts of Large Scale Wind Penetration on Energy Supply Industry

    Directory of Open Access Journals (Sweden)

    John Kabouris

    2009-11-01

    Full Text Available Large penetration of Renewable Energy Sources (RES impacts Energy Supply Industry (ESI in many aspects leading to a fundamental change in electric power systems. It raises a number of technical challenges to the Transmission System Operators (TSOs, Distribution System Operators (DSOs and Wind Turbine Generators (WTG constructors. This paper aims to present in a thorough and coherent way the redrawn picture for Energy Systems under these conditions. Topics related to emergent technical challenges, technical solutions required and finally the impact on ESI due to large wind power penetration, are analyzed. Finally, general conclusions are extracted about the ESI current and future state and general directions are recommended.

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

    Directory of Open Access Journals (Sweden)

    Kartono R.

    2014-03-01

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

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

    Science.gov (United States)

    Kartono, R.; Basuki, Y. T.

    2014-03-01

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

  6. How can a policy foster local pharmaceutical production and still protect public health? Lessons from the health-industry complex in Brazil.

    Science.gov (United States)

    da Fonseca, Elize Massard

    2018-04-01

    The global health community is increasingly advocating for the local production of pharmaceuticals in developing countries as a way to promote technology transfer, capacity building and improve access to medicines. However, efforts to advance drug manufacturing in these countries revive an old dilemma of fostering technological development versus granting access to social services, such as healthcare. This paper explores the case of Brazil, a country that has developed large-scale health-inspired industrial policies, but is, yet, little understood. Brazil's experience suggests that progressive healthcare bureaucrats can create innovative practices for technology and knowledge transfers. It also demonstrates that highly competitive pharmaceutical firms can collaborate with each other, if a government provides them the right incentives. Reforming regulatory policies is crucial for guaranteeing high-quality products in developing countries, but governments must play a crucial role in supporting local firms to adapt to these regulations. These findings send a strong message to global health policymakers and practitioners on the conditions to create a suitable environment for local production of medical products.

  7. Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation

    International Nuclear Information System (INIS)

    Kostich, Mitchell S.; Batt, Angela L.; Lazorchak, James M.

    2014-01-01

    We measured concentrations of 56 active pharmaceutical ingredients (APIs) in effluent samples from 50 large wastewater treatment plants across the US. Hydrochlorothiazide was found in every sample. Metoprolol, atenolol, and carbamazepine were found in over 90% of the samples. Valsartan had the highest concentration (5300 ng/L), and also had the highest average concentration (1600 ng/L) across all 50 samples. Estimates of potential risks to healthy human adults were greatest for six anti-hypertensive APIs (lisinopril, hydrochlorothiazide, valsartan, atenolol, enalaprilat, and metoprolol), but nevertheless suggest risks of exposure to individual APIs as well as their mixtures are generally very low. Estimates of potential risks to aquatic life were also low for most APIs, but suggest more detailed study of potential ecological impacts from four analytes (sertraline, propranolol, desmethylsertraline, and valsartan). -- Highlights: • Report concentrations of 56 pharmaceuticals in effluents from 50 wastewater plants. • Model and measurements agree that potential risks to healthy adult humans are low. • Model and measurements agree some uncertainties remain about risks to aquatic life. -- Measurements of pharmaceuticals in municipal effluent suggest risks of exposure to healthy human adults are low, but suggest the need for study of potential impacts on aquatic life

  8. Continuing medical education and pharmaceutical industry involvement: An evaluation of policies adopted by Canadian professional medical associations.

    Science.gov (United States)

    Shnier, Adrienne; Lexchin, Joel

    2017-01-01

    Professional medical associations (PMAs) play a crucial role in providing accredited continuing medical education (CME) to physicians. Funding from the pharmaceutical industry may lead to biases in CME. This study examines publicly available policies on CME, adopted by Canadian PMAs as of December 2015. Policies were evaluated using an original scoring tool comprising 21 items, two questions about PMAs' general and CME funding from industry, and three enforcement measures. We assessed 236 policies adopted by Canadian PMAs (range, 0 to 32). Medical associations received summative scores that ranged from 0% to 49.2% of the total possible points (maximum score = 63). Twenty-seven associations received an overall score of 0%. The highest mean scores were achieved in the areas of industry involvement in planning CME activities (mean: 1.1/3), presence of a review process for topics of CME activities (mean: 1.1/3), content review for balanced information (mean: 1.1/3), and responsibility of distribution of funds (mean: 1.0/3). The lowest mean scores were achieved in the areas of awards (mean: 0.0/3), industry personnel, representatives, and employees (mean: 0.1/3), distribution of industry-funded educational materials at CME activities (mean: 0.1/3), and distinction between marketing and educational materials (mean: 0.1/3). These results suggest that Canadian PMAs' publicly available policies on industry involvement in CME are generally weak or non-existent; therefore, the accredited CME that is provided to Canadian physicians may be viewed as open to bias. We encourage all Canadian medical associations to strengthen their policies to avoid the potential for industry influence in CME.

  9. The return of the pharmaceutical industry to the market of contraception.

    Science.gov (United States)

    Johansson, E D

    2000-01-01

    In the 1980s and 1990s, the litigious climate in the US had a catastrophic effect on sales of many major contraceptives. Although oral contraceptives escaped controversy, the intrauterine device (IUD) and Norplant(R) were two targets of damaging litigation. The IUD was withdrawn from the market in 1985. Since 1994 when the attacks began against Norplant, its US sales have dramatically declined, even though no fault has been found in the method or its development. In general, pharmaceutical companies were extremely hesitant to develop new contraceptives during this period. The bleak outlook, however, began to shift in the late 1990s, as fertility rates began to decrease worldwide and contraceptive users increased. By 2025, 2500 million women will comprise the customer base for contraception. Global pharmaceutical companies are now participating in expanding markets overseas and have launched and continue to develop a range of new long-term reversible, and highly effective, contraceptive products outside the traditional oral contraceptive field. Two new contraceptives on the way to the US market are: Mirena, a levonorgestrel-releasing intrauterine system manufactured by Schering-Leiras; and Implanon, a single implant system manufactured by Organon of the Netherlands. Other birth control methods soon to be launched include: emergency contraceptives, the contraceptive patch, monthly contraceptive injections, mifepristone for medical abortion, and modified oral contraceptives.

  10. The Determinants of Research and Development Investment in the Pharmaceutical Industry: Focus on Financial Structures

    Science.gov (United States)

    Lee, Munjae; Choi, Mankyu

    2015-01-01

    Objectives This study analyzes the influence of the financial structure of pharmaceutical companies on R&D investment to create a next-generation profit source or develop relatively cost-effective drugs to maximize enterprise value. 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 (KLCA), and data related to stock price is extracted from KISVALUE-Ⅲ of NICE Information Service Co., Ltd. Stata 12.0 was used as the statistical package for panel analysis. Results The current ratio had a positive influence on R&D investment, the debt ratio had a negative influence on R&D investment, and return on investment and net sales growth rate did not have a significant influence on R&D investment. Conclusion It was found in this study that the higher liquidity ratio, the greater the R&D investment. The stability of pharmaceutical companies has a negative influence on R&D investment. This finding is consistent with the prediction that if a company faces a financial risk, it will be passive in R&D investment due to its financial difficulties. PMID:26730355

  11. The Determinants of Research and Development Investment in the Pharmaceutical Industry: Focus on Financial Structures.

    Science.gov (United States)

    Lee, Munjae; Choi, Mankyu

    2015-10-01

    This study analyzes the influence of the financial structure of pharmaceutical companies on R&D investment to create a next-generation profit source or develop relatively cost-effective drugs to maximize enterprise value. 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 (KLCA), and data related to stock price is extracted from KISVALUE-Ⅲ of NICE Information Service Co., Ltd. Stata 12.0 was used as the statistical package for panel analysis. The current ratio had a positive influence on R&D investment, the debt ratio had a negative influence on R&D investment, and return on investment and net sales growth rate did not have a significant influence on R&D investment. It was found in this study that the higher liquidity ratio, the greater the R&D investment. The stability of pharmaceutical companies has a negative influence on R&D investment. This finding is consistent with the prediction that if a company faces a financial risk, it will be passive in R&D investment due to its financial difficulties.

  12. Environmental quality indexing of large industrial development alternatives using AHP

    International Nuclear Information System (INIS)

    Solnes, Julius

    2003-01-01

    Two industrial development alternatives have been proposed for the East Coast of Iceland in order to strengthen its socio-economic basis. The favoured option is to build a large aluminium smelter, which requires massive hydropower development in the nearby highlands. Another viable option is the construction of a 6-million-ton oil refinery, following the planned exploitation of the Timan Pechora oil reserves in the Russian Arctic. A third 'fictitious' alternative could be general development of existing regional industry and new knowledge-based industries, development of ecotourism, establishment of national parks, accompanied by infrastructure improvement (roads, tunnels, communications, schools, etc.). The three alternatives will have different environmental consequences. The controversial hydropower plant for the smelter requires a large water reservoir as well as considerable land disturbance in this unique mountain territory, considered to be the largest uninhabited wilderness in Western Europe. The aluminium smelter and the oil refinery will give rise to substantial increase of the greenhouse gas (GHG) emissions of the country (about 20%). Then there is potential environmental risk associated with the refinery regarding oil spills at sea, which could have disastrous impact on the fisheries industry. However, the oil refinery does not require any hydropower development, which is a positive factor. Finally, the third alternative could be defined as a ''green'' solution whereby the detrimental environmental consequences of the two industrial solutions are mostly avoided. In order to compare the three alternatives in an orderly manner, the analytic hierarchy process methodology of Saaty was applied to calculate the environmental quality index of each alternative, which is defined as a weighted sum of selected environmental and socio-economic factors. These factors are evaluated on a comparison basis, applying the AHP methodology, and the weights in the quality

  13. Non-Conventional Applications of Computerized Tomography: Analysis of Solid Dosage Forms Produced by Pharmaceutical Industry

    International Nuclear Information System (INIS)

    Martins de Oliveira, Jose Jr.; Germano Martins, Antonio Cesar

    2010-01-01

    X-ray computed tomography (CT) refers to the cross-sectional imaging of an object measuring the transmitted radiation at different directions. In this work, we describe a non-conventional application of computerized tomography: visualization and improvements in the understanding of some internal structural features of solid dosage forms. A micro-CT X-ray scanner, with a minimum resolution of 30 μm was used to characterize some pharmaceutical tablets, granules, controlled-release osmotic tablet and liquid-filled soft-gelatin capsules. The analysis presented in this work are essentially qualitative, but quantitative parameters, such as porosity, density distribution, tablets dimensions, etc. could also be obtained using the related CT techniques.

  14. Angiotensin-I-Converting Enzyme (ACE Inhibitors from Marine Resources: Prospects in the Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Isuru Wijesekara

    2010-03-01

    Full Text Available Hypertension or high blood pressure is one of the major independent risk factors for cardiovascular diseases. Angiotensin-I-converting enzyme (EC 3.4.15.1; ACE plays an important physiological role in regulation of blood pressure by converting angiotensin I to angiotensin II, a potent vasoconstrictor. Therefore, the inhibition of ACE activity is a major target in the prevention of hypertension. Recently, the search for natural ACE inhibitors as alternatives to synthetic drugs is of great interest to prevent several side effects and a number of novel compounds such as bioactive peptides, chitooligosaccharide derivatives (COS and phlorotannins have been derived from marine organisms as potential ACE inhibitors. These inhibitory derivatives can be developed as nutraceuticals and pharmaceuticals with potential to prevent hypertension. Hence, the aim of this review is to discuss the marine-derived ACE inhibitors and their future prospects as novel therapeutic drug candidates for treat hypertension.

  15. Giat Industries selected for construction of the "Very Large Telescope"

    Science.gov (United States)

    1995-06-01

    Versailles-Satory (France) May 31, 1995 - Giat Industries has just obtained a contract from the European Southern Observatory (ESO) for the construction of the primary and tertiary mirror supports and the positioning apparatus of the world's largest optical telescope. This contract, worth almost 140 million francs, represents over 100,000 hours of work. It was won by Gitech, a division of Giat Industries, in collaboration with the Sfim group, following an international competition between the largest European groups in the space field. Gitech is charged with the development of civil and military industrial equipment for the Giat Industries group, in particular in high technology fields. The VLT (Very Large Telescope) will be installed in Chile before the year 2000; the delivery schedule provides for reception of the first assembly in May 1997. It will consist of four telescopes of 8.2m diameter, providing, in its most powerful configuration, a close-up view of an object measuring one meter on the surface of the moon. The cell, built by Gitech, is one of the key parts of the telescope. It mainly consists of a very rigid metal structure and an electro-hydraulic system of more that 200 hydraulic jacks and 150 electrically-controlled jacks linking the metallic structure to the mirror. This structure, produced to an original design of laser-welded steel chambers, weighs less than 10 tonnes and will support over 37 tonnes of mirror and equipment, while guaranteeing precise positioning to within a micron. The electro-hydraulic jack system, manufactured in collaboration with the Sfim group, will support and position the mirror, and correct its geometry by applying a precise distribution of forces to its rear. The assembly is designed to meet the requirements of para-seismic safety. Gitech is also producing the computerised control system to ensure the operation and the reliability of the assembly.

  16. Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization.

    Science.gov (United States)

    Grady, Haiyan; Elder, David; Webster, Gregory K; Mao, Yun; Lin, Yiqing; Flanagan, Talia; Mann, James; Blanchard, Andy; Cohen, Michael J; Lin, Judy; Kesisoglou, Filippos; Hermans, Andre; Abend, Andreas; Zhang, Limin; Curran, David

    2018-01-01

    This article intends to summarize the current views of the IQ Consortium Dissolution Working Group, which comprises various industry companies, on the roles of dissolution testing throughout pharmaceutical product development, registration, commercialization, and beyond. Over the past 3 decades, dissolution testing has evolved from a routine and straightforward test as a component of end-product release into a comprehensive set of tools that the developer can deploy at various stages of the product life cycle. The definitions of commonly used dissolution approaches, how they relate to one another and how they may be applied in modern drug development, and life cycle management is described in this article. Specifically, this article discusses the purpose, advantages, and limitations of quality control, biorelevant, and clinically relevant dissolution methods. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  17. Environmental sustainability of the solar photo-Fenton process for wastewater treatment and pharmaceuticals mineralization at semi-industrial scale.

    Science.gov (United States)

    Foteinis, Spyros; Monteagudo, Jose Maria; Durán, Antonio; Chatzisymeon, Efthalia

    2018-01-15

    The environmental sustainability of a semi-industrial solar photo-Fenton reactor, treating real effluents emanating from a pharmaceutical laboratory, is assessed herein. The life cycle assessment/analysis (LCA) methodology was employed and real life cycle inventory (LCI) data was collected from a ferrioxalate-assisted homogeneous solar photo-Fenton wastewater treatment plant (WWTP), at Ciudad Real, Spain. Electricity was provided by photovoltaic (PV) panels in tandem with a battery bank, making the plant autonomous from the local grid. The effective treatment of 1m 3 of secondary-treated pharmaceutical wastewater, containing antipyrine, was used as a functional unit. The main environmental hotspot was identified to be the chemical reagents used to enhance treatment efficiency, mainly hydrogen peroxide (H 2 O 2 ) and to a smaller degree oxalic acid. On the other hand, land use, PV panels, battery units, compound parabolic collectors (CPC), tanks, pipes and pumps, as materials, had a low contribution, ranging from as little as 0.06% up to about 2% on the total CO 2eq emissions. Overall, the solar photo-Fenton process was found to be a sustainable technology for treating wastewater containing micropollutants at semi-industrial level, since the total environmental footprint was found to be 2.71kgCO 2 m -3 or 272mPtm -3 , using IPCC 2013 and ReCiPe impact assessment methods, respectively. A sensitivity analysis revealed that if the excess of solar power is fed back into the grid then the total environmental footprint is reduced. Depending on the amount of solar power fed back into the grid the process could have a near zero total environmental footprint. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Possibility of the microbiological decontamination by irradiation of talc for pharmaceutical and industrial use

    International Nuclear Information System (INIS)

    Espinosa, R.; Varela, A.

    1988-01-01

    The sterilization of talc is a demand of the national industry and health system. The results of a feasibility study on the radiosterilization of talc for industrial use and the manufacture of tablets using the Producto 1 facility are reviewed. It was found that a minimum dose of 25 kGy allows elimination of all microorganisms present. This assertion was proved through application of microbiological control according to the current Cuba standards. Physiochemical analysis of the irradiated talc demonstrated that the treatment did not cause detrimental changes of the product

  19. Innovation in the pharmaceutical industry: New estimates of R&D costs.

    Science.gov (United States)

    DiMasi, Joseph A; Grabowski, Henry G; Hansen, Ronald W

    2016-05-01

    The research and development costs of 106 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug and biologics development. The costs of compounds abandoned during testing were linked to the costs of compounds that obtained marketing approval. The estimated average out-of-pocket cost per approved new compound is $1395 million (2013 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a real discount rate of 10.5% yields a total pre-approval cost estimate of $2558 million (2013 dollars). When compared to the results of the previous study in this series, total capitalized costs were shown to have increased at an annual rate of 8.5% above general price inflation. Adding an estimate of post-approval R&D costs increases the cost estimate to $2870 million (2013 dollars). Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Electronic Noses and Tongues: Applications for the Food and Pharmaceutical Industries

    Directory of Open Access Journals (Sweden)

    Sharon Dea

    2011-05-01

    Full Text Available The electronic nose (e-nose is designed to crudely mimic the mammalian nose in that most contain sensors that non-selectively interact with odor molecules to produce some sort of signal that is then sent to a computer that uses multivariate statistics to determine patterns in the data. This pattern recognition is used to determine that one sample is similar or different from another based on headspace volatiles. There are different types of e-nose sensors including organic polymers, metal oxides, quartz crystal microbalance and even gas-chromatography (GC or combined with mass spectroscopy (MS can be used in a non-selective manner using chemical mass or patterns from a short GC column as an e-nose or “Z” nose. The electronic tongue reacts similarly to non-volatile compounds in a liquid. This review will concentrate on applications of e-nose and e-tongue technology for edible products and pharmaceutical uses.

  1. Chemical and Microbial Dynamics during Composting of Herbal Pharmaceutical Industrial Waste

    Directory of Open Access Journals (Sweden)

    Farhan Zameer

    2010-01-01

    Full Text Available A study was performed to analyze the dynamics of chemical, biochemical and microbial parameters during composting of herbal pharmaceutical waste. All the parameters were analyzed at three different intervals of composting (1st, 15th and 60th days. Temperature of the compost pile was initially high (46.2 °C and on 60th day it dropped to 33.3 °C. The pH of the sample was initially acidic (2.39 and with the progress of decomposition gradually changed to neutrality (7.55. Electrical conductivity (EC value was high (3.8 mS during last day of composting compared to other stages. The activity of degradative enzymes namely amylase, invertase and urease were initially high (4.1, 4.79 mg of glucose/g/h and 0.19 mg of ammonia/g/h respectively while it decreased with composting. The beneficial microbial load was initially low and very high at the last stages of decomposition. The bioassay studies using compost extracts revealed that the 60th day old sample was not phytotoxic in nature.

  2. Optimization of large-scale industrial systems : an emerging method

    Energy Technology Data Exchange (ETDEWEB)

    Hammache, A.; Aube, F.; Benali, M.; Cantave, R. [Natural Resources Canada, Varennes, PQ (Canada). CANMET Energy Technology Centre

    2006-07-01

    This paper reviewed optimization methods of large-scale industrial production systems and presented a novel systematic multi-objective and multi-scale optimization methodology. The methodology was based on a combined local optimality search with global optimality determination, and advanced system decomposition and constraint handling. The proposed method focused on the simultaneous optimization of the energy, economy and ecology aspects of industrial systems (E{sup 3}-ISO). The aim of the methodology was to provide guidelines for decision-making strategies. The approach was based on evolutionary algorithms (EA) with specifications including hybridization of global optimality determination with a local optimality search; a self-adaptive algorithm to account for the dynamic changes of operating parameters and design variables occurring during the optimization process; interactive optimization; advanced constraint handling and decomposition strategy; and object-oriented programming and parallelization techniques. Flowcharts of the working principles of the basic EA were presented. It was concluded that the EA uses a novel decomposition and constraint handling technique to enhance the Pareto solution search procedure for multi-objective problems. 6 refs., 9 figs.

  3. Application of large radiation sources in chemical processing industry

    International Nuclear Information System (INIS)

    Krishnamurthy, K.

    1977-01-01

    Large radiation sources and their application in chemical processing industry are described. A reference has also been made to the present developments in this field in India. Radioactive sources, notably 60 Co, are employed in production of wood-plastic and concrete-polymer composites, vulcanised rubbers, polymers, sulfochlorinated paraffin hydrocarbons and in a number of other applications which require deep penetration and high reliability of source. Machine sources of electrons are used in production of heat shrinkable plastics, insulation materials for cables, curing of paints etc. Radiation sources have also been used for sewage hygienisation. As for the scene in India, 60 Co sources, gamma chambers and batch irradiators are manufactured. A list of the on-going R and D projects and organisations engaged in research in this field is given. (M.G.B.)

  4. Industrial metrology as applied to large physics experiments

    International Nuclear Information System (INIS)

    Veal, D.

    1993-05-01

    A physics experiment is a large complex 3-D object (typ. 1200 m 3 , 35000 tonnes), with sub-millimetric alignment requirements. Two generic survey alignment tasks can be identified; first, an iterative positioning of the apparatus subsystems in space and, second, a quantification of as-built parameters. The most convenient measurement technique is industrial triangulation but the complexity of the measured object and measurement environment constraints frequently requires a more sophisticated approach. To enlarge the ''survey alignment toolbox'' measurement techniques commonly associated with other disciplines such as geodesy, applied geodesy for accelerator alignment, and mechanical engineering are also used. Disparate observables require a heavy reliance on least squares programs for campaign pre-analysis and calculation. This paper will offer an introduction to the alignment of physics experiments and will identify trends for the next generation of SSC experiments

  5. Industrial metrology as applied to large physics experiments

    Energy Technology Data Exchange (ETDEWEB)

    Veal, D.

    1993-05-01

    A physics experiment is a large complex 3-D object (typ. 1200 m{sup 3}, 35000 tonnes), with sub-millimetric alignment requirements. Two generic survey alignment tasks can be identified; first, an iterative positioning of the apparatus subsystems in space and, second, a quantification of as-built parameters. The most convenient measurement technique is industrial triangulation but the complexity of the measured object and measurement environment constraints frequently requires a more sophisticated approach. To enlarge the ``survey alignment toolbox`` measurement techniques commonly associated with other disciplines such as geodesy, applied geodesy for accelerator alignment, and mechanical engineering are also used. Disparate observables require a heavy reliance on least squares programs for campaign pre-analysis and calculation. This paper will offer an introduction to the alignment of physics experiments and will identify trends for the next generation of SSC experiments.

  6. Strategies for patient empowerment through the promotion of medicines in Israel: regulatory framework for the pharmaceutical industry.

    Science.gov (United States)

    Schwartzberg, Eyal; Barnett-Itzhaki, Zohar; Grotto, Itamar; Marom, Eli

    2017-09-29

    The correct and rational use of medications can have a positive direct impact on disease outcomes, as well on the utilization of the health system resources. Unfortunately, 50% of the patients do not take their medications as prescribed, largely due to lack of patients' understanding of their medical condition, as well as the lack of reliable medicine information.There are multiple strategies implemented in many countries to tackle this challenge including: disease awareness campaigns (DAC) to raise the public awareness to specific diseases, direct-to-consumer advertisement (DTCA) to raise the public awareness to prescription medicines, specific treatments and over-the-counter (OTC) products to improve the accessibility of patients to specific medicines.Prior to 2013, the Israeli policy prohibited prescribing medication advertising and prevented the flow of information from pharmaceutical companies to the patient. In the last five years, the Pharmaceutical division in the Israeli Ministry of Health, as part of the "empowering the patient" agenda, has taken new innovative approaches to raise public awareness to diseases, medications and appropriate usage, as well as promotion of information to improve patient adherence to the prescribed medication.This paper elaborates on the aforementioned strategies implemented in developed countries, and specifically focuses on newly implemented strategies and regulations in Israel regarding pre- and post-prescription information, to improve patient appropriate utilization and adherence to medication.

  7. Treatment of real effluents from the pharmaceutical industry: A comparison between Fenton oxidation and conductive-diamond electro-oxidation.

    Science.gov (United States)

    Pérez, J F; Llanos, J; Sáez, C; López, C; Cañizares, P; Rodrigo, M A

    2017-06-15

    Wastewater produced in pharmaceutical manufacturing plants (PMPs), especially the one coming from organic-synthesis facilities, is characterized by its large variability due to the wide range of solvents and chemical reagents used in the different stages of the production of medicines. Normally, the toxicity of the organic compounds prevent the utilization of biological processes and more powerful treatments are needed becoming advanced oxidation processes (AOPs) a valid alternative. In this work, the efficiency in abatement of pollution by Fenton oxidation (FO) and conductive-diamond electro-oxidation (CDEO) are compared in the treatment of 60 real effluents coming from different processes carried out in a pharmaceutical facility, using standardized tests. In 80% of the samples, CDEO was found to be more efficient than FO and in the remaining 20%, coagulation was found to exhibit a great significance in the COD abatement mechanism during FO, pointing out the effectiveness of the oxidation promoted by the electrochemical technology. Mean oxidation state of carbon was found to be a relevant parameter to understand the behavior of the oxidation technologies. It varied inversely proportional to efficiency in FO and it showed practically no influence in the case of CDEO. Copyright © 2016 Elsevier Ltd. All rights reserved.

  8. Gateway to the Future. Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories.

    Science.gov (United States)

    Education Development Center, Inc., Newton, MA.

    The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceutical companies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…

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

    Science.gov (United States)

    Singh, Deepika; Suthar, Surindra

    2012-05-01

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

  10. PDA survey of quality risk management practices in the pharmaceutical, devices, & biotechnology industries.

    Science.gov (United States)

    Ahmed, Ruhi; Baseman, Harold; Ferreira, Jorge; Genova, Thomas; Harclerode, William; Hartman, Jeffery; Kim, Samuel; Londeree, Nanette; Long, Michael; Miele, William; Ramjit, Timothy; Raschiatore, Marlene; Tomonto, Charles

    2008-01-01

    In July 2006 the Parenteral Drug Association's Risk Management Task Force for Aseptic Processes, conducted an electronic survey of PDA members to determine current industry practices regarding implementation of Quality Risk Management in their organizations. This electronic survey was open and publicly available via the PDA website and targeted professionals in our industry who are involved in initiating, implementing, or reviewing risk management programs or decisions in their organizations. One hundred twenty-nine members participated and their demographics are presented in the sidebar "Correspondents Profile". Among the major findings are: *The "Aseptic Processing/Filling" operation is the functional area identified as having the greatest need for risk assessment and quality risk management. *The most widely used methodology in industry to identify risk is Failure Mode and Effects Analysis (FMEA). This tool was most widely applied in assessing change control and for adverse event, complaint, or failure investigations. *Despite the fact that personnel training was identified as the strategy most used for controlling/minimizing risk, the largest contributors to sterility failure in operations are still "Personnel". *Most companies still rely on "Manufacturing Controls" to mitigate risk and deemed the utilization of Process Analytical Technology (PAT) least important in this aspect. *A majority of correspondents verified that they did not periodically assess their risk management programs. *A majority of the correspondents desired to see case studies or examples of risk analysis implementation (as applicable to aseptic processing) in future PDA technical reports on risk management.

  11. THE GENERIC DRUGS LAUNCH AND THEIR IMPACT ON THE COMPETITIVE STRATEGIES OF THE BRAZILIAN PHARMACEUTICAL INDUSTRY

    OpenAIRE

    FELIPE DAVID COHEN

    2004-01-01

    O propósito deste estudo é analisar o advento dos genéricos e verificar seu impacto nas estratégias competitivas implementadas por empresas da indústria farmacêutica brasileira. Este trabalho adota como base o estudo de Michael Porter sobre tipologias, identificando as estratégias relevantes e os grupamentos existentes nesse segmento industrial, buscando também relacionar o posicionamento estratégico assumido pelos laboratórios ao desempenho observado. O método ...

  12. Concentrations of prioritized pharmaceuticals in effluents from 50 large wastewater treatment plants in the US and implications for risk estimation.

    Science.gov (United States)

    Kostich, Mitchell S; Batt, Angela L; Lazorchak, James M

    2014-01-01

    We measured concentrations of 56 active pharmaceutical ingredients (APIs) in effluent samples from 50 large wastewater treatment plants across the US. Hydrochlorothiazide was found in every sample. Metoprolol, atenolol, and carbamazepine were found in over 90% of the samples. Valsartan had the highest concentration (5300 ng/L), and also had the highest average concentration (1600 ng/L) across all 50 samples. Estimates of potential risks to healthy human adults were greatest for six anti-hypertensive APIs (lisinopril, hydrochlorothiazide, valsartan, atenolol, enalaprilat, and metoprolol), but nevertheless suggest risks of exposure to individual APIs as well as their mixtures are generally very low. Estimates of potential risks to aquatic life were also low for most APIs, but suggest more detailed study of potential ecological impacts from four analytes (sertraline, propranolol, desmethylsertraline, and valsartan). Published by Elsevier Ltd.

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

    Science.gov (United States)

    Makowska, Marta

    2017-08-10

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

  14. Plant seeds as sources of potential industrial chemicals, pharmaceuticals, and pest control agents.

    Science.gov (United States)

    Powell, Richard G

    2009-03-27

    Investigations of natural products isolated from seeds have resulted in a remarkable variety of compounds having unusual structures. Seeds of many plant species contain uncommon fatty acids and lipids, some of which have found uses in the cosmetic industry or as renewable (non-petroleum based) industrial raw materials. In addition to proteins and energy storage substances such as carbohydrates and lipids, seeds generally contain, or have the ability to produce, protective compounds that are active as plant growth regulators, fungicides, insecticides, and repellents of herbivores; seeds occasionally contain compounds that are toxic to most other organisms. These compounds may also be present in other plant parts, but often are found at higher concentrations in seeds. Other compounds of interest have been associated with plant-endophyte interactions that are of mutual benefit to both organisms. Tests of seed extracts for cytotoxic and antitumor activity, toxicity to insects, and relationships to several animal disease syndromes have been revealing. Examples of compounds isolated from plant seeds that have served as lead compounds for additional research, or that continue to be of interest to researchers in multiple areas, are reviewed.

  15. Health technology assessment and comparative effectiveness research: a pharmaceutical industry perspective.

    Science.gov (United States)

    Hao, Yanni; Thomas, Adrian

    2013-08-01

    We briefly review the characteristics of several established health technology assessment (HTA) programs in industrialized societies including Germany, the UK and France. Special attention is paid on two issues: the position of HTA in coverage decision making and the role of economic assessment in evaluation processes. Although law makers in the USA have barred the use of NICE's cost/quality-adjusted life year or similar health economics approaches by public payers for coverage decision making, there are suggestions of prioritizing relative efficacy evaluation over economic assessment under a comparative effectiveness research (CER) framework to inform payment rates of public payers (an approach similar to German and French HTA processes). However, such an approach is unlikely to prove viable. It should also be noted that, if cost considerations are made explicit in US CER policy decisions, CER may become an unsustainable approach undermined by a conflicting emphasis on both cost containment and a demand for costly comparative evidence. On the other hand, properly designed CER initiatives can serve as a facilitator of more efficient research activities and drug development models. With these points in mind, the likely pathway of US CER is explored and the plausible impact on industry innovation is discussed.

  16. Implementation of a protein profiling platform developed as an academic-pharmaceutical industry collaborative effort.

    Science.gov (United States)

    Végvári, Akos; Magnusson, Mattias; Wallman, Lars; Ekström, Simon; Bolmsjö, Gunnar; Nilsson, Johan; Miliotis, Tasso; Ostling, Jörgen; Kjellström, Sven; Ottervald, Jan; Franzén, Bo; Hultberg, Hans; Marko-Varga, György; Laurell, Thomas

    2008-06-01

    As much attention has devoted to the proteome research during the last few years, biomarker discovery has become an increasingly hot area, potentially enabling the development of new assays for diagnosis and prognosis of severe diseases. This is the field of research interest where efforts originating from both academic and industrial groups should jointly work on solutions. In this paper, we would like to demonstrate the fruitful combination of both research domains where the scientific crossroads sprout fresh ideas from the basic research domain and how these are refined and tethered to industrial standards. We will present an approach that is based on novel microfluidic devices, utilizing their benefits in processing small-volume samples. Our biomarker discovery strategy, built around this platform, involves optimized samples processing (based on SPE and sample enrichment) and fast MALDI-MS readout. The identification of novel biomarkers at low-abundance level has been achieved by the utilization of a miniaturized sample handling platform, which offers clean-up and enrichment of proteins in one step. Complete automation has been realized in the form of a unique robotic instrumentation that is able to extract and transfer 96 samples onto standard MALDI target plates with high throughput. The developed platform was operated with a 60 sample turnaround per hour allowing sensitivities in femtomol regions of medium- and low-abundant target proteins from clinical studies on samples of multiple sclerosis and gastroesophageal reflux disease. Several proteins have been identified as new biomarkers from cerebrospinal fluid and esophagus epithelial cells.

  17. Interactions between physicians and the pharmaceutical industry generally and sales representatives specifically and their association with physicians' attitudes and prescribing habits: a systematic review.

    Science.gov (United States)

    Fickweiler, Freek; Fickweiler, Ward; Urbach, Ewout

    2017-09-27

    The objective of this review is to explore interactions between physicians and the pharmaceutical industry including sales representatives and their impact on physicians' attitude and prescribing habits. PubMed, Embase, Cochrane Library and Google scholar electronic databases were searched from 1992 to August 2016 using free-text words and medical subject headings relevant to the topic. Studies included cross-sectional studies, cohort studies, randomised trials and survey designs. Studies with narrative reviews, case reports, opinion polls and letters to the editor were excluded from data synthesis. Two reviewers independently extracted the data. Data on study design, study year, country, participant characteristics, setting and number of participants were collected. Pharmaceutical industry and pharmaceutical sales representative (PSR) interactions influence physicians' attitudes and their prescribing behaviour and increase the number of formulary addition requests for the company's drug. Physician-pharmaceutical industry and its sales representative's interactions and acceptance of gifts from the company's PSRs have been found to affect physicians' prescribing behaviour and are likely to contribute to irrational prescribing of the company's drug. Therefore, intervention in the form of policy implementation and education about the implications of these interactions is needed. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  18. Pharmaceutical Cocrystals

    OpenAIRE

    Korotkova, Elena I.; Kratochvíl, B.

    2014-01-01

    Cocrystals are very interesting and useful product. In this paper the main information about cocrystals is presented. It is shown that cocrystals are solid substances, which consist of few components mixed together. There are a lot of ways of cocrystals production and application. It is shown that cocrystals can be applied in medicine and pharmaceutical industry for improving different properties such as dissolution rate, melting point, solubility, chemical stability etc. Another way of cocry...

  19. Antibacterial Effects of Cinnamon: From Farm to Food, Cosmetic and Pharmaceutical Industries

    Directory of Open Access Journals (Sweden)

    Seyed Fazel Nabavi

    2015-09-01

    Full Text Available Herbs and spices have been used since ancient times, because of their antimicrobial properties increasing the safety and shelf life of food products by acting against foodborne pathogens and spoilage bacteria. Plants have historically been used in traditional medicine as sources of natural antimicrobial substances for the treatment of infectious disease. Therefore, much attention has been paid to medicinal plants as a source of alternative antimicrobial strategies. Moreover, due to the growing demand for preservative-free cosmetics, herbal extracts with antimicrobial activity have recently been used in the cosmetic industry to reduce the risk of allergies connected to the presence of methylparabens. Some species belonging to the genus Cinnamomum, commonly used as spices, contain many antibacterial compounds. This paper reviews the literature published over the last five years regarding the antibacterial effects of cinnamon. In addition, a brief summary of the history, traditional uses, phytochemical constituents, and clinical impact of cinnamon is provided.

  20. Antibacterial Effects of Cinnamon: From Farm to Food, Cosmetic and Pharmaceutical Industries

    Science.gov (United States)

    Nabavi, Seyed Fazel; Di Lorenzo, Arianna; Izadi, Morteza; Sobarzo-Sánchez, Eduardo; Daglia, Maria; Nabavi, Seyed Mohammad

    2015-01-01

    Herbs and spices have been used since ancient times, because of their antimicrobial properties increasing the safety and shelf life of food products by acting against foodborne pathogens and spoilage bacteria. Plants have historically been used in traditional medicine as sources of natural antimicrobial substances for the treatment of infectious disease. Therefore, much attention has been paid to medicinal plants as a source of alternative antimicrobial strategies. Moreover, due to the growing demand for preservative-free cosmetics, herbal extracts with antimicrobial activity have recently been used in the cosmetic industry to reduce the risk of allergies connected to the presence of methylparabens. Some species belonging to the genus Cinnamomum, commonly used as spices, contain many antibacterial compounds. This paper reviews the literature published over the last five years regarding the antibacterial effects of cinnamon. In addition, a brief summary of the history, traditional uses, phytochemical constituents, and clinical impact of cinnamon is provided. PMID:26378575

  1. Users Ability to Share Knowledge when Integrated in New Product Development - Evidence from the Pharmaceutical Industry

    DEFF Research Database (Denmark)

    Smed, Marie; Salomo, Søren; Schultz, Carsten

    their professional experiences, but also concerningissues, which go beyond their pre-defined role. The overall research question for this paper is therefore: Can usersability to share their knowledge obtained in product development integration be differentiated by topic area? Are topicareas related to their own......In technological intensive industries knowledge input from both internal and external sources is crucial (Ahuja 2000,Gulati ét al. 2000, Von Hippel 2005; Thompson 2005). A highly well informed and increasingly recognized source ofknowledge is users of these technological products. By establishing...... and maintaining a close network with key users,firms can tap into unique knowledge, which can be useful in product development processes (Urban and von Hippel1988, Shah 2000, Rothwell 1994). Previous studies have here pointed to the professional capabilities of users, whichmay generate a community of common...

  2. Pharmaceutical virtue.

    Science.gov (United States)

    Martin, Emily

    2006-06-01

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

  3. Knowledge, Beliefs and Attitudes of Patients and the General Public towards the Interactions of Physicians with the Pharmaceutical and the Device Industry: A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Racha Fadlallah

    Full Text Available To systematically review the evidence on the knowledge, beliefs, and attitudes of patients and the general public towards the interactions of physicians with the pharmaceutical and the device industry.We included quantitative and qualitative studies addressing any type of interactions between physicians and the industry. We searched MEDLINE and EMBASE in August 2015. Two reviewers independently completed data selection, data extraction and assessment of methodological features. We summarized the findings narratively stratified by type of interaction, outcome and country.Of the 11,902 identified citations, 20 studies met the eligibility criteria. Many studies failed to meet safeguards for protecting from bias. In studies focusing on physicians and the pharmaceutical industry, the percentages of participants reporting awareness was higher for office-use gifts relative to personal gifts. Also, participants were more accepting of educational and office-use gifts compared to personal gifts. The findings were heterogeneous for the perceived effects of physician-industry interactions on prescribing behavior, quality and cost of care. Generally, participants supported physicians' disclosure of interactions through easy-to-read printed documents and verbally. In studies focusing on surgeons and device manufacturers, the majority of patients felt their care would improve or not be affected if surgeons interacted with the device industry. Also, they felt surgeons would make the best choices for their health, regardless of financial relationship with the industry. Participants generally supported regulation of surgeon-industry interactions, preferably through professional rather than governmental bodies.The awareness of participants was low for physicians' receipt of personal gifts. Participants also reported greater acceptability and fewer perceived influence for office-use gifts compared to personal gifts. Overall, there appears to be lower awareness

  4. Knowledge, Beliefs and Attitudes of Patients and the General Public towards the Interactions of Physicians with the Pharmaceutical and the Device Industry: A Systematic Review.

    Science.gov (United States)

    Fadlallah, Racha; Nas, Hala; Naamani, Dana; El-Jardali, Fadi; Hammoura, Ihsan; Al-Khaled, Lina; Brax, Hneine; Kahale, Lara; Akl, Elie A

    2016-01-01

    To systematically review the evidence on the knowledge, beliefs, and attitudes of patients and the general public towards the interactions of physicians with the pharmaceutical and the device industry. We included quantitative and qualitative studies addressing any type of interactions between physicians and the industry. We searched MEDLINE and EMBASE in August 2015. Two reviewers independently completed data selection, data extraction and assessment of methodological features. We summarized the findings narratively stratified by type of interaction, outcome and country. Of the 11,902 identified citations, 20 studies met the eligibility criteria. Many studies failed to meet safeguards for protecting from bias. In studies focusing on physicians and the pharmaceutical industry, the percentages of participants reporting awareness was higher for office-use gifts relative to personal gifts. Also, participants were more accepting of educational and office-use gifts compared to personal gifts. The findings were heterogeneous for the perceived effects of physician-industry interactions on prescribing behavior, quality and cost of care. Generally, participants supported physicians' disclosure of interactions through easy-to-read printed documents and verbally. In studies focusing on surgeons and device manufacturers, the majority of patients felt their care would improve or not be affected if surgeons interacted with the device industry. Also, they felt surgeons would make the best choices for their health, regardless of financial relationship with the industry. Participants generally supported regulation of surgeon-industry interactions, preferably through professional rather than governmental bodies. The awareness of participants was low for physicians' receipt of personal gifts. Participants also reported greater acceptability and fewer perceived influence for office-use gifts compared to personal gifts. Overall, there appears to be lower awareness, less concern and

  5. The Applied Aspects of Transposition and Integration of Development Resources in the System of Strategic Management of the Pharmaceutical Industry Enterprises

    Directory of Open Access Journals (Sweden)

    Mykhailiuk Myroslava О.

    2018-02-01

    Full Text Available The article is aimed at researching the transposition and integration of development resources in the system of strategic management of pharmaceutical enterprises. It has been determined that in the current of market functioning, resources are transformed into development resources. The proposed scheme of transposition and integration of development resources in the system of strategic management of enterprises provides a combination of resource opportunities of company with market conditions and reflects synergistic interaction between two classical theories of strategic management: the M. Porter’s sectoral competition theory and the resource theory. The basic priorities of development of the pharmaceutical industry in the contemporary market environment are defined and trends of activity of pharmaceutical companies are indicated. Enterprises are distributed according to the criterion of introduction of development resources strategy, measures on increase of efficiency of their activity are suggested.

  6. Pharmaceutical compounds in drinking water

    Directory of Open Access Journals (Sweden)

    Vikas Chander

    2016-06-01

    Full Text Available Pharmaceutical products and their wastes play a major role in the degradation of environment. These drugs have positive as well as negative consequences on different environmental components including biota in different ways. Many types of pharmaceutical substances have been detected with significant concentrations through various advanced instrumental techniques in surface water, subsurface water, ground water, domestic waste water, municipal waste water and industrial effluents. The central as well as state governments in India are providing supports by creating excise duty free zones to promote the pharmaceutical manufacturers for their production. As a result, pharmaceutical companies are producing different types of pharmaceutical products at large scale and also producing complex non-biodegradable toxic wastes byproducts and releasing untreated or partially treated wastes in the environment in absence of strong regulations. These waste pollutants are contaminating all types of drinking water sources. The present paper focuses on water quality pollution by pharmaceutical pollutants, their occurrences, nature, metabolites and their fate in the environment.

  7. Federalism, the economic-industrial health care complex and high-cost pharmaceutical assistance in Brazil.

    Science.gov (United States)

    da Fonseca, Elize Massard; Costa, Nilson do Rosario

    2015-04-01

    Brazil has a relevant, although relatively unknown, special medicines programme that distributes high-cost products, such as drugs needed for cancer treatments. In 2009, the purchase of these medicines became the responsibility of the Brazilian Federal Government. Until then, there were no clear norms regarding the responsibilities, in terms of the management/financing of these medicines, of the Brazilian Federal Government and of the states themselves. This qualitative study analyses the policy process needed to transfer this programme to the central government. The study examines the reports of the Tripartite Commission between 2000 and 2012, and in-depth interviews with eleven key informants were conducted. The study demonstrates that throughout the last decade, institutional changes have been made in regard to the federal management of these programmes (such as recentralisation of the purchasing of medicines). It concludes that these changes can be explained because of the efficiency of the coordinating mechanisms of the Federal Government. These findings reinforce the idea that the Ministry of Health is the main driver of public health policies, and it has opted for the recentralisation of activities as a result of the development project implicit in the agenda of the Industrial and Economic Heal.

  8. Pharmaceutical policies in European countries.

    Science.gov (United States)

    Barros, Pedro Pita

    2010-01-01

    Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers. To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies. Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a "silver bullet" to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).

  9. Numerical simulation of low-pulsation gerotor pumps for use in the pharmaceutical industry and in biomedicine

    Directory of Open Access Journals (Sweden)

    Klopsch Vincent

    2015-09-01

    Full Text Available The reduction of the pulsation of flow and pressure as well as the increase of the mean flow of a displacement pump will be a benefit to many technical processes, especially in the pharmaceutical industry and in biomedicine. By reducing the flow pulsation, microreactors could work more efficiently and thin-film coatings or fluids in biomedical applications could be applied with more precision. This article presents a new toolbox to analyse and compare different types of gerotor pump gear profiles. The main objective was the development of a toolbox to analyse the mean flow and the flow ripple of theoretical and reverse engineered gerotor gear sets. For that reason, the presented toolbox does not work with analytic functions, but with numerical methods based on point cloud data. A comparison of four different profile types shows that these profiles perform very differently if they are limited by a given maximal outer root diameter and by the numbers of the teeth of both rotors.

  10. Occurrence of pharmaceuticals and personal care products, and their associated environmental risks in a large shallow lake in north China.

    Science.gov (United States)

    Zhang, Panwei; Zhou, Huaidong; Li, Kun; Zhao, Xiaohui; Liu, Qiaona; Li, Dongjiao; Zhao, Gaofeng

    2018-01-13

    Eighteen selected pharmaceuticals and personal care products (PPCPs), consisting of five non-antibiotic pharmaceuticals (N-APs), four sulfonamides (SAs), four tetracyclines (TCs), four macrolides (MCs), and one quinolone (QN) were detected in water, pore water, and sediment samples from Baiyangdian Lake, China. A total of 31 water samples and 29 sediment samples were collected in March 2017. Caffeine was detected with 100% frequency in surface water, pore water, and sediment samples. Carbamazepine was detected with 100% frequency in surface water and sediment samples. Five N-APs were prominent, with mean concentrations of 4.90-266.24 ng/l in surface water and 5.07-14.73 μg/kg in sediment samples. Four MCs were prominent, with mean concentrations of 0.97-29.92 ng/l in pore water samples. The total concentrations of the different classes of PPCPs followed the order: N-APs (53.26%) > MCs (25.39) > SAs (10.06%) > TCs (7.64%) > QNs (3.64%) in surface water; N-APs (42.70%) > MCs (25.43%) > TCs (14.69%) > SAs (13.90%) > QNs (3.24%) in sediment samples, and MCs (42.12%) > N-APs (34.80%) > SAs (11.71%) > TCs (7.48%) > QNs (3.88%) in pore water samples. The geographical differences of PPCP concentrations were largely due to anthropogenic activities. Sewage discharged from Baoding City and human activities around Baiyangdian Lake were the main sources of PPCPs in the lake. An environmental risk assessment for the upper quartile concentration was undertaken using calculated risk quotients and indicated a low or medium-high risk from 18 PPCPs in Baiyangdian Lake and its five upstream rivers.

  11. Funding pharmaceutical innovation through direct tax credits.

    Science.gov (United States)

    Lybecker, Kristina M; Freeman, Robert A

    2007-07-01

    Rising pharmaceutical prices, increasing demand for more effective innovative drugs and growing public outrage have heightened criticism of the pharmaceutical industry. The public debate has focused on drug prices and access. As a consequence, the patent system is being reexamined as an efficient mechanism for encouraging pharmaceutical innovation and drug development. We propose an alternative to the existing patent system, instead rewarding the innovating firm with direct tax credits in exchange for marginal cost pricing. This concept is based on the fundamental assumption that innovation that benefits society at large may be financed publicly. As an industry which produces a social good characterized by high fixed costs, high information and regulatory costs, and relatively low marginal costs of production, pharmaceuticals are well-suited to such a mechanism. Under this proposal, drug prices fall, consumer surplus increases, access is enhanced, and the incentives to innovate are preserved.

  12. Nontarget analysis of polar contaminants in freshwater sediments influenced by pharmaceutical industry using ultra-high-pressure liquid chromatography-quadrupole time-of-flight mass spectrometry

    International Nuclear Information System (INIS)

    Terzic, Senka; Ahel, Marijan

    2011-01-01

    A comprehensive analytical procedure for a reliable identification of nontarget polar contaminants in aquatic sediments was developed, based on the application of ultra-high-pressure liquid chromatography (UHPLC) coupled to hybrid quadrupole time-of-flight mass spectrometry (QTOFMS). The procedure was applied for the analysis of freshwater sediment that was highly impacted by wastewater discharges from the pharmaceutical industry. A number of different contaminants were successfully identified owing to the high mass accuracy of the QTOFMS system, used in combination with high chromatographic resolution of UHPLC. The major compounds, identified in investigated sediment, included a series of polypropylene glycols (n = 3-16), alkylbenzene sulfonate and benzalkonium surfactants as well as a number of various pharmaceuticals (chlorthalidone, warfarin, terbinafine, torsemide, zolpidem and macrolide antibiotics). The particular advantage of the applied technique is its capability to detect less known pharmaceutical intermediates and/or transformation products, which have not been previously reported in freshwater sediments. - Research highlights: → UHPLC-QTOFMS coupling was applied for nontarget analysis of polar contaminants. → Wide spectrum of polar contaminants was identified in polluted sediments. → Pharmaceuticals and their intermediates were present in high concentrations. - Comprehensive analysis of freshwater sediments by UPLC/QTOF indicated importance of pharmaceutically-derived polar contaminants.

  13. Nontarget analysis of polar contaminants in freshwater sediments influenced by pharmaceutical industry using ultra-high-pressure liquid chromatography-quadrupole time-of-flight mass spectrometry

    Energy Technology Data Exchange (ETDEWEB)

    Terzic, Senka, E-mail: terzic@irb.h [Division of Marine and Environmental Research, Rudjer Boskovic Institute, 10000 Zagreb (Croatia); Ahel, Marijan [Division of Marine and Environmental Research, Rudjer Boskovic Institute, 10000 Zagreb (Croatia)

    2011-02-15

    A comprehensive analytical procedure for a reliable identification of nontarget polar contaminants in aquatic sediments was developed, based on the application of ultra-high-pressure liquid chromatography (UHPLC) coupled to hybrid quadrupole time-of-flight mass spectrometry (QTOFMS). The procedure was applied for the analysis of freshwater sediment that was highly impacted by wastewater discharges from the pharmaceutical industry. A number of different contaminants were successfully identified owing to the high mass accuracy of the QTOFMS system, used in combination with high chromatographic resolution of UHPLC. The major compounds, identified in investigated sediment, included a series of polypropylene glycols (n = 3-16), alkylbenzene sulfonate and benzalkonium surfactants as well as a number of various pharmaceuticals (chlorthalidone, warfarin, terbinafine, torsemide, zolpidem and macrolide antibiotics). The particular advantage of the applied technique is its capability to detect less known pharmaceutical intermediates and/or transformation products, which have not been previously reported in freshwater sediments. - Research highlights: UHPLC-QTOFMS coupling was applied for nontarget analysis of polar contaminants. Wide spectrum of polar contaminants was identified in polluted sediments. Pharmaceuticals and their intermediates were present in high concentrations. - Comprehensive analysis of freshwater sediments by UPLC/QTOF indicated importance of pharmaceutically-derived polar contaminants.

  14. Valorization of solid wastes from chestnut industry processing: Extraction and optimization of polyphenols, tannins and ellagitannins and its potential for adhesives, cosmetic and pharmaceutical industry.

    Science.gov (United States)

    Aires, Alfredo; Carvalho, Rosa; Saavedra, Maria José

    2016-02-01

    The aim of the current study was to evaluate the potential of chestnut peels to produce pomaces enhanced with tannins to be used in the formulations of wood adhesives, leather tanning or as natural antioxidants in food, cosmetic and pharmaceutical industry. An analytical procedure was planned as 2 factorial design to analyze the influence of solvent (water, Na2SO3 and NaOH at different concentrations of 1, 2, 4, and 8% in water) and extraction time (30, 60, and 120, 240, 480 and 960min) on extraction yield, pH, Stiasny index, and tannins. HPLC-diode array detector equipped with an ionization mass spectrophotometer was used to assess the polyphenol composition. Our results showed that both extraction properties and phytochemicals were significantly affected (Ptannins identified were the hydrolyzable gallic acid, vescalagin castalagin and ellagic acid, and the condensed epigallocatechin, catechin and epicatechin. The solvent 1% Na2SO3 was more effective to extract the condensed tannins whilst hydrolyzable tannins were extracted efficiently by 1% NaOH. The multivariable analysis and the Pearson's correlation coefficients showed a direct association between Stiasny number and the average levels of condensed tannins. Copyright © 2015 Elsevier Ltd. All rights reserved.

  15. Emerging Genetic Counselor Roles within the Biotechnology and Pharmaceutical Industries: as Industry Interest Grows in Rare Genetic Disorders, How are Genetic Counselors Joining the Discussion?

    Science.gov (United States)

    Field, Tessa; Brewster, Stephanie Jo; Towne, Meghan; Campion, MaryAnn W

    2016-08-01

    Traditionally, the biotechnology and pharmaceutical industry (BPI) has focused drug development at the mass-market level targeting common medical issues. However, a recent trend is the development of therapies for orphan or rare disorders, including many genetic disorders. Developing treatments for genetic disorders requires an understanding of the needs of the community and translating genomic information to clinical and non-clinical audiences. The core skills of genetic counselors (GCs) include a deep knowledge of genetics and ability to communicate complex information to a broad audience, making GCs a choice fit for this shift in drug development. To date there is limited data defining the roles GCs hold within this industry. This exploratory study aimed to define the roles and motivation of GCs working in BPI, assess job satisfaction, and identify translatable skills and current gaps in GC training programs. The authors surveyed 26 GCs working in BPI in the United States; 79 % work for companies focused on rare disorders. GC positions in BPI are growing, with 57 % of respondents being the first GC in their role. GCs in BPI continue to utilize core genetic counseling competencies, though 72 % felt their training did not fully prepare them for BPI. These data suggest opportunities for exposure to BPI in GC training to better prepare future generations of GCs for these career opportunities. GC satisfaction was high in BPI, notably in areas traditionally reported as less satisfying on the National Society for Genetic Counselors Professional Status Survey: salary and advancement opportunities. BPI's growing interest in rare disorders represents a career opportunity for GCs, addressing both historic areas of dissatisfaction for GCs and BPI's genomic communication needs.

  16. Gamma Ray Tomographic Scan Method for Large Scale Industrial Plants

    International Nuclear Information System (INIS)

    Moon, Jin Ho; Jung, Sung Hee; Kim, Jong Bum; Park, Jang Geun

    2011-01-01

    The gamma ray tomography systems have been used to investigate a chemical process for last decade. There have been many cases of gamma ray tomography for laboratory scale work but not many cases for industrial scale work. Non-tomographic equipment with gamma-ray sources is often used in process diagnosis. Gamma radiography, gamma column scanning and the radioisotope tracer technique are examples of gamma ray application in industries. In spite of many outdoor non-gamma ray tomographic equipment, the most of gamma ray tomographic systems still remained as indoor equipment. But, as the gamma tomography has developed, the demand on gamma tomography for real scale plants also increased. To develop the industrial scale system, we introduced the gamma-ray tomographic system with fixed detectors and rotating source. The general system configuration is similar to 4 th generation geometry. But the main effort has been made to actualize the instant installation of the system for real scale industrial plant. This work would be a first attempt to apply the 4th generation industrial gamma tomographic scanning by experimental method. The individual 0.5-inch NaI detector was used for gamma ray detection by configuring circular shape around industrial plant. This tomographic scan method can reduce mechanical complexity and require a much smaller space than a conventional CT. Those properties make it easy to get measurement data for a real scale plant

  17. Exploring Multidimensional View of Intellectual Capital and Business Ethics on Organizational Performance by Using Bootstrapping Method: Evidence from Pakistani Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Rizwan Raheem Ahmed

    2017-03-01

    Full Text Available The objective of this research is to examine the effect of business ethics (BE and intellectual capital (IC on the organizational performance (OP. In order to run this study, a conceptual model was designed based on the literature review, and the employees of the knowledge-based organization in pharmaceutical sector were surveyed using a closed-ended questionnaire. Modern successful and thriving organizations are those that create IC and convert it into applicable methods to improve their activities and performance within the boundaries of BE. This research is exploratory and quantitative in nature: 400 responses were directly gathered from the employees of the pharmaceutical industry through five-scaled questionnaire. This research examined the direct and indirect effect of BE and IC on the OP. Structural equation modeling (SEM, descriptive statistics, correlation, multiple regression techniques were used to analyze the impact of IC and BE on the performance. Bootstrapping method is employed in order to test the mediating effect of variables. Two-step SEM was used to the models to regress the cause and effect relation. The findings depicted that there is a very significant effect on BE and IC in the performance of pharmaceutical organizations. General BE, ethics in finance, ethics in human resource management, and ethics in sales and marketing have direct and significant impact on the OP. Human capital, structural capital and relational capital have significant indirect (mediating effect on the performance of the pharmaceutical industry. Finally, it has been concluded from the results of the research study that IC is the major contributor of the OP as a mediating variable with defined set of principles of BE in the pharmaceutical sector of Pakistan.

  18. Access to essential medicines for sexual and reproductive health care: the role of the pharmaceutical industry and international regulation.

    Science.gov (United States)

    Cottingham, Jane; Berer, Marge

    2011-11-01

    The range of medicines and technologies that are essential for sexual and reproductive health care is well established, but access to them is far from universally assured, particularly in less developed countries. This paper shows how the pharmaceutical industry plays a major role in the lack of access to essential medicines for sexual and reproductive health care, by a) investing in products for profit-making reasons despite their negative health impact (e.g. hormone replacement therapy), b) marketing new essential medicines at prices beyond the reach of countries that most need them (e.g. HPV vaccines), and c) failing to invest in the development of new products (e.g. microbicides and medical abortion pills). Small companies, some of them non-profit-making, struggle to fill some of that demand (e.g. for female condoms). International patent protection contributes to high prices of medicines, and while international agreements such as compulsory licensing under TRIPS and the Medicines Patent Pool allow for mechanisms to enable poorer countries to get access to essential medicines, the obstacles created by "big pharma" are daunting. All these barriers have fostered a market in sub-standard medicines (e.g. fake medical abortion pills sold over the internet). An agenda driven by sexual and reproductive health needs, based on the right to health, must focus on universal access to essential medicines at prices developing countries can afford. We call for greater public investment in essential medicines, expanded production of affordable generic drugs, and the development of broad strategic plans, that include affordable medicines and technologies, for addressing identified public health problems, such as cervical cancer. Copyright © 2011 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.

  19. Does brand differentiate pharmaceuticals?

    Science.gov (United States)

    Bednarik, Josef

    2005-12-01

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

  20. Experimental industrial signal acquisition board in a large scientific device

    Science.gov (United States)

    Zeng, Xiangzhen; Ren, Bin

    2018-02-01

    In order to measure the industrial signal of neutrino experiment, a set of general-purpose industrial data acquisition board has been designed. It includes the function of switch signal input and output, and the function of analog signal input. The main components are signal isolation amplifier and filter circuit, ADC circuit, microcomputer systems and isolated communication interface circuit. Through the practical experiments, it shows that the system is flexible, reliable, convenient and economical, and the system has characters of high definition and strong anti-interference ability. Thus, the system fully meets the design requirements.

  1. Preclinical Pharmacokinetic/Pharmacodynamic Modeling and Simulation in the Pharmaceutical Industry: An IQ Consortium Survey Examining the Current Landscape

    OpenAIRE

    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

    2015-01-01

    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...

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

    Science.gov (United States)

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

    2011-09-15

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

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

    Science.gov (United States)

    Vystavna, Yuliya

    2014-05-01

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

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

    Science.gov (United States)

    Sanderson, Hans; Thomsen, Marianne

    2009-06-01

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

  5. [Bioequivalence studies of pharmaceutical preparations].

    Science.gov (United States)

    Vetchý, D; Frýbortová, K; Rabisková, M; Danecková, H

    2007-01-01

    Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs. The target of such study is to evaluate the therapeutic compatibility of tested drugs (pharmaceutical equivalents or pharmaceutical alternatives). The importance of bioequivalence studies is increasing also due to the large growth of the production and consumption of generic products. Generic products represent approximately 50 % of the whole consumption in many European countries and USA. The search output of bioequivalence study is together with the pharmaceutical quality data of medical product one of the main part of the registration file submitted to a national regulatory authorities. The registration of generic products does not demand complicated and expensive clinical study contrary to original product. The comparison of the original and the generic product via bioequivalence study is suggested as sufficient. The aim of this article is to provide to a medical public a summary about the types of bioequivalence studies, their range, rules of their practise and let them gain their own attitude to this question.

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

    DEFF Research Database (Denmark)

    Sanderson, Hans; Thomsen, Marianne

    2009-01-01

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

  7. Analysis of the importance of drug packaging quality for end users and pharmaceutical industry as a part of the quality management system

    Directory of Open Access Journals (Sweden)

    Lončar Irma M.

    2013-01-01

    Full Text Available In this study, we collected and analyzed information on the importance of drug packaging quality to end users and pharmaceutical industry, as an indicator of the process of traceability and originality of drugs. Two surveys were conducted: one among the end users of drugs (252 patients and the other among professionals working in seven pharmaceutical companies in Serbia. For most end users (82.5% quality on the packaging of drugs was important, but only 41.8% of them thought that the appearance of the packaging could be an indicator of genuinity of drugs. The existence of the control marks (KM on drug packaging was not of great importance, since most of them (86.9% know, its function, but majority (60.2% would nevertheless decide to buy the drug without KM. Regarding the experts from the pharmaceutical industry, more then two-thirds of them (68.4% believed that the existence of KM did not contribute to efficient operations. Although a great number of pharmaceutical industry professionals (84.2% answered that the introduction of GS1 DataMatrix system would allow for complete traceability of the drug from the manufacturer to the end user, only 22.2% of them introduced this system to their products. This study also showed that domestic producers did not have a great interest for additional protection (special inks, holograms, special graphics, smart multicolor design, watermark, chemically labeled paper and cardboard etc.. on their products, given that only 15.8 % of them had some kind of additional protection against counterfeiting. Monitoring drug traceability from a manufacturer to end user is achieved by many complex activities regulated by law. A high percentage of responders said they were satisfied with the functionality of traceability systems used in their companies. As a way to increase the quality of drug packaging and business performance most responders saw in the continuous improvement of the system of traceability within the company

  8. The need for a transparent, ethical, and successful relationship between academic scientists and the pharmaceutical industry: a view of the Group for the Respect of Ethics and Excellence in Science (GREES).

    Science.gov (United States)

    Bruyere, O; Kanis, J A; Ibar-Abadie, M-E; Alsayed, N; Brandi, M L; Burlet, N; Cahall, D L; Chines, A; Devogelaer, J-P; Dere, W; Goel, N; Hughes, N; Kaufman, J-M; Korte, S; Mitlak, B H; Niese, D; Rizzoli, R; Rovati, L C; Reginster, J-Y

    2010-05-01

    This paper provides recommendations for fair and unbiased relationship between academic scientists and the pharmaceutical industry. Real or perceived problems in the relationship between academics and the industry have been the subject of much recent debate. It has been suggested that academic clinicians should sever all links with the industry-a view that is rarely challenged. Academic experts and members of the pharmaceutical industry were invited to an expert consensus meeting to debate this topic. This meeting was organized by the Group for the Respect of Ethics and Excellence in Science. Conflict of interest, competing interest, right and duties of academic scientist, authorship, and staff and student education were discussed. Guidelines for a transparent, ethical, strong, and successful partnership between the academic scientist and the pharmaceutical industry have been provided. The Group support interactions between the industry and clinicians provided that it is transparent and ethical.

  9. Chemical process research and development in the 21st century: challenges, strategies, and solutions from a pharmaceutical industry perspective.

    Science.gov (United States)

    Federsel, Hans-Jürgen

    2009-05-19

    In process research and development (PR&D), the generation and manipulation of small-molecule drugs ranges from bench-scale (laboratory) chemistry to pilot plant manufacture to commercial production. A broad range of disciplines, including process chemistry (organic synthesis), analytical chemistry, process engineering (mass and heat transfer, unit operations), process safety (chemical risk assessment), regulatory compliance, and plant operation, must be effectively applied. In the critical handover between medicinal chemistry and PR&D, compound production is typically scaled up from a few hundred grams to several kilograms. Can the methodologies applied to the former also satisfy the technical, safety, and scalability aspects that come into play in the latter? Occasionally, the transition might occur smoothly, but more often the situation is the opposite: much work and resources must be invested to design a process that is feasible for manufacturing on pilot scale and, eventually, for commercial production. Authentic examples provide enlightening illustrations of dos and don'ts for developing syntheses designed for round-flask operation into production-scale processes. Factors that are easily underestimated or even neglected in the laboratory, such as method robustness, chemical hazards, safety concerns, environmental impact, availability of starting materials and building blocks in bulk quantities, intellectual property (IP) issues, and the final cost of the product, will come into play and need to be addressed appropriately. The decision on which route will be the best for further development is a crucial event and should come into focus early on the R&D timeline. In addition to scientific and technical concerns, the parameter of speed has come to the forefront in the pharmaceutical arena. Although historically the drug industry has tolerated a total time investment of far more than 10 years from idea to market, the current worldwide paradigm requires a

  10. Pharmaceutical technology management--profitable business avenue.

    Science.gov (United States)

    Puthli, Shivanand P

    2010-01-01

    Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business.

  11. Tropical Journal of Pharmaceutical Research

    African Journals Online (AJOL)

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

  12. Respecting the right to access to medicines: Implications of the UN Guiding Principles on Business and Human Rights for the pharmaceutical industry.

    Science.gov (United States)

    Moon, Suerie

    2013-06-14

    What are the human rights responsibilities of pharmaceutical companies with regard to access to medicines? The state-based international human rights framework has long struggled with the issue of the human rights obligations of non-state actors, a question sharpened by economic globalization and the concomitant growing power of private for-profit actors ("business"). In 2011, after a six-year development process, the UN Human Rights Council unanimously endorsed the Guiding Principles advanced by the UN Secretary General's Special Representative on Business and Human Rights, John Ruggie. The Ruggie Principles sought to clarify and differentiate the responsibilities of states and non-state actors-in this case, "business" -with respect to human rights. The framework centered on "three core principles: the state duty to protect against human rights abuses by third parties, including business; the corporate responsibility to respect human rights; and the need for more effective access to remedies." The "Protect, Respect, and Remedy" Framework emerged from a review of many industrial sectors operating from local to global scales, in many regions of the world, and involving multiple stakeholder consultations. However, their implications for the pharmaceutical industry regarding access to medicines remain unclear. This article analyzes the 2008 Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines advanced by then-UN Special Rapporteur on the Right to Health, Paul Hunt, in light of the Ruggie Principles. It concludes that some guidelines relate directly to the industry's responsibility to respect the right to access to medicines, and form a normative baseline to which firms should be held accountable. It also finds that responsibility for other guidelines may better be ascribed to states than to private actors, based on conceptual and practical considerations. While not discouraging the pharmaceutical industry from making additional

  13. Industry potential of large scale uses for peaceful nuclear explosives

    International Nuclear Information System (INIS)

    Russell, P.L.

    1969-01-01

    The industrial potential for peaceful uses of nuclear explosions entering a critical stage of development. Should Project Gasbuggy, an experiment to determine to what extent an underground nuclear explosion can stimulate the production of natural gas from low-permeability formations, prove a technical or economic success, a great step forward will have been made. Should other experiments now being considered in natural gas, oil shale, copper, coal, water resources, underground storage, and others, also demonstrate technical or economic advantage, it is conceivable to expect peaceful nuclear explosion to grow from our current rate of one or two experimental shots per year to hundreds of production explosions per year. This growth rate could be severely restricted or reduced to zero if public safety and environmental control cannot be exercised. (author)

  14. Industry potential of large scale uses for peaceful nuclear explosives

    Energy Technology Data Exchange (ETDEWEB)

    Russell, P L [Bureau of Mines, Denver, CO (United States)

    1969-07-01

    The industrial potential for peaceful uses of nuclear explosions entering a critical stage of development. Should Project Gasbuggy, an experiment to determine to what extent an underground nuclear explosion can stimulate the production of natural gas from low-permeability formations, prove a technical or economic success, a great step forward will have been made. Should other experiments now being considered in natural gas, oil shale, copper, coal, water resources, underground storage, and others, also demonstrate technical or economic advantage, it is conceivable to expect peaceful nuclear explosion to grow from our current rate of one or two experimental shots per year to hundreds of production explosions per year. This growth rate could be severely restricted or reduced to zero if public safety and environmental control cannot be exercised. (author)

  15. RESEARCH ON COMPLEX, LARGE INDUSTRIAL PROJECTS IN TRANSNATIONAL ENVIRONMENT

    Directory of Open Access Journals (Sweden)

    Florin POPESCU

    2016-12-01

    Full Text Available More and more projects from different industrial sectors developed in transnational environment are becoming more characterized as "complex". In recent years, there has been much discussion and controversy about the complexity of the projects, and, despite what has been written and said in various papers, journals and professional conferences, more confusion than clarification was created, complexity of projects being interpreted differently from one author to another. Most of the literature studied is based on linear, analytical and rational approach, focusing on the size of project management planning and control and actually less on projects that are characterized as taking place and grow into a dynamic socio-human environment in a continuous change. This study represents a critical review of existing theoretical models found in literature, highlighting their limitations. The output of this literature study represents an integration of different approaches concerning complexity under one umbrella to provide a common understanding of the evolution of this concept.

  16. Continuous improvement concepts as a link between quality assurance and implementation of cleaner production: Case study in the generic pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Boltić Zorana

    2016-01-01

    Full Text Available The subject and the research objective presented in this article is establishing of the relationship between quality assurance and implementation of cleaner production in the generic pharmaceutical industry through the comprehensive concept of continuous improvement. This is mostly related to application of Lean and Six Sigma tools and techniques for process improvement and their link to other known concepts used in the industrial environment, especially manufacturing of generic pharmaceutical products from which two representative case studies were selected for comparative analysis, also considering relevant regulatory requirements in the field of quality management, as well as appropriate quality standards. Although the methodology discussed in this conceptual and practice oriented article is strongly related to chemical engineering, the focus is mainly on process industry, i.e. production systems, rather than any specific technological process itself. The scope of this research is an engineering approach to evaluation of the production systems in terms of continuous improvement concepts application, considering both quality aspects and efficiency of such systems. [Projekat Ministarstva nauke Republike Srbije, br. TR 34009

  17. Actitud de los médicos frente a las prácticas de promoción de la industria farmacéutica The attitude of physicians regarding the promotion strategies of the pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Leonardo Castresana

    2005-06-01

    Full Text Available Hay evidencia de que las prácticas de promoción de la industria farmacéutica influyen en los patrones de prescripción de los médicos y en el consumo de medicamentos, pudiendo generar conflictos de intereses que alteren el juicio clínico. El objetivo del presente trabajo fue estimar la frecuencia con que los médicos reciben beneficios de la industria farmacéutica y su opinión acerca de este tipo de actividades de promoción. Se realizó un estudio multicéntrico, descriptivo, de corte transversal en el cual se aplicó una encuesta anónima, autoadministrada, a médicos/as clínicos, cardiólogos y dermatólogos que practican atención ambulatoria de adultos en la ciudad de Buenos Aires. De 96 cuestionarios entregados se recuperaron 78 (tasa de respuesta 81%. La edad promedio fue de 41 años, 44% fueron mujeres y 35% residentes. El 86% de los encuestados recibe muestras médicas con elevada frecuencia, 39% útiles de escritorio, 19% inscripciones a congresos y 12% invitaciones a comer. La mitad de los médicos opina que los beneficios de la industria farmacéutica influyen en la prescripción, pero sólo el 27% reconoce que modifica su propia prescripción. Los residentes consideran con mayor frecuencia que estas actividades los afectan (42% vs. 18% p = 0.007, global: 30%; La mayoría de los encuestados considera apropiado recibir estos beneficios. Sin embargo, el 35% acuerda que éstos inciden en el costo final de los medicamentos. En conclusión, la población encuestada muestra una alta interacción con la industria farmacéutica. Si bien reconocen que las actividades de promoción influyen en la prescripción y elevan el costo final de los productos, encuentran apropiado recibir esos beneficios.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

  18. Opportunities for Data Science in the Pharmaceutical Industry: The Use of Data to Find Efficiencies in Drug Development Can?t Come Too Soon.

    Science.gov (United States)

    Keshava, Nirmal

    2017-01-01

    By the numbers, 2016 was not a good year for the U.S. pharmaceutical industry. As of early December, only 19 new drugs had been approved by the Food and Drug Administration (FDA), fewer than half of those approved in 2015 and the lowest number since 2007. Further, the FDA approved only 61% of submissions in 2016, compared to 95% in 2015 [1]. And, among the largest companies, the return on investment for research and development (R&D) fell to 3.7% [2].

  19. Multivariate statistical modelling of the pharmaceutical process of wet granulation and tableting

    NARCIS (Netherlands)

    Westerhuis, Johannes Arnold

    1997-01-01

    Wet granulation in high-shear mixers is a process of particle size enlargement much used in the pharmaceutical industry to improve the tableting properties of powder mixtures, such as flowability and compactibility, necessary for the large scale production of pharmaceutical talbets. ... Zie: Summary

  20. Dual market structures and the likelihood of repeated ties - evidence from pharmaceutical biotechnology

    NARCIS (Netherlands)

    Roijakkers, A.H.W.M.; Hagedoorn, J.; Kranenburg, van H.

    2005-01-01

    This paper analyses the role of repeated ties in the high-tech pharmaceutical biotechnology industry, a sector that is characterized by a strong dual market structure. Our most important finding is that previous ties in pairs of large pharmaceutical companies and small biotechnology firms have a

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

    Science.gov (United States)

    Lee, Munjae; Choi, Mankyu

    2015-08-01

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

  2. Pharmaceutical cocrystals: an overview.

    Science.gov (United States)

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

    2011-10-31

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

  3. Coding of DNA samples and data in the pharmaceutical industry: current practices and future directions--perspective of the I-PWG.

    Science.gov (United States)

    Franc, M A; Cohen, N; Warner, A W; Shaw, P M; Groenen, P; Snapir, A

    2011-04-01

    DNA samples collected in clinical trials and stored for future research are valuable to pharmaceutical drug development. Given the perceived higher risk associated with genetic research, industry has implemented complex coding methods for DNA. Following years of experience with these methods and with addressing questions from institutional review boards (IRBs), ethics committees (ECs) and health authorities, the industry has started reexamining the extent of the added value offered by these methods. With the goal of harmonization, the Industry Pharmacogenomics Working Group (I-PWG) conducted a survey to gain an understanding of company practices for DNA coding and to solicit opinions on their effectiveness at protecting privacy. The results of the survey and the limitations of the coding methods are described. The I-PWG recommends dialogue with key stakeholders regarding coding practices such that equal standards are applied to DNA and non-DNA samples. The I-PWG believes that industry standards for privacy protection should provide adequate safeguards for DNA and non-DNA samples/data and suggests a need for more universal standards for samples stored for future research.

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

    Science.gov (United States)

    Serajuddin, Hamida K; Serajuddin, Abu T M

    2006-01-01

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

  5. Enantiomeric separation of pharmaceutically important drug intermediates using a Metagenomic lipase and optimization of its large scale production.

    Science.gov (United States)

    Kumar, Rakesh; Banoth, Linga; Banerjee, Uttam Chand; Kaur, Jagdeep

    2017-02-01

    In the present study, efficient enzymatic methods were developed using a recombinant metagenomic lipase (LipR1) for the synthesis of corresponding esters by the transesterification of five different pharmaceutically important secondary alcohols. The recombinant lipase (specific activity=87m6U/mg) showed maximum conversion in presence of ionic liquid with Naphthyl-ethanol (eeP=99%), Indanol and Methyl-4 pyridine methanol (eeS of 98% and 99%) respectively in 1h. Vinyl acetate was found as suitable acyl donor in transesterification reactions. It was interesting to observe that maximum eeP of 85% was observed in just 15min with 1-indanol. As this enzyme demonstrated pharmaceutical applications, attempts were made to scale up the enzyme production on a pilot scale in a 5litre bioreactor. Different physical parameters affecting enzyme production and biomass concentration such as agitation rate, aeration rate and inoculum concentration were evaluated. Maximum lipase activity of 8463U/ml was obtained at 7h of cultivation at 1 lpm, 300rpm and 1.5% inoculum. Copyright © 2016 Elsevier B.V. All rights reserved.

  6. [Drug advertising as communication between the pharmaceutical industry and the physician: advertisements for psychotropic drugs in the Dutch medical journal, Nederlands Tijdschrift voor Geneeskunde, 1900-1940].

    Science.gov (United States)

    van der Hoogte, Arjo Roersch; Pieters, Toine

    2010-01-01

    In this article we explore the historical development of drug advertisements for psychotropic drugs in the leading Dutch medical journal from 1900 to 1940. The advertisements for hypnotics and sedatives, in The Nederlands Tijdschrift voor Geneeskunde (Dutch medical journal) reflected the changes in the vocabulary and image promoted by the pharmaceutical companies. In the first two decades, the advertisements were sober and to the point, and included the trademark, company name, molecular formula and therapeutic properties of the medication. The emphasis was on creating a scientific image of reliable symptom control for the therapeutic drug. In doing so, the ethical drug companies tried (successfully) to distinguish themselves from the producers of patent medicines. Once scientific credibility was established, the form and content of the advertisements changed significantly. In the late 1920s and 1930s drug companies embraced modern advertising techniques, developing a figurative language to address the changing beliefs and practices of Dutch physicians. Instead of promoting therapeutic drugs as safe and scientific, the emphasis was on their effectiveness in comparison to similar drugs. In the process, scientific information was reduced to an indispensable standardized minimum, whereby therapeutic drugs were advertised according to the latest pharmacological taxonomy rather than molecular formulas. The image-making of 'ethical marketing' began during the interwar years when marketers applied modern advertising techniques and infotainment strategies. The scanty black and white informational bulletins transitioned into colourful advertisements. The pharmaceutical companies employed the same medical language as used by physicians, so that one word or image in an advertisement would suffice for the physician to recognize a drug and its therapeutic properties. These developments show the changing relationship between the modern ethical pharmaceutical industry and Dutch

  7. Remuneration for non-interventional studies – results of a survey in the pharmaceutical industry in Germany

    Directory of Open Access Journals (Sweden)

    Thorsten Ruppert

    2012-02-01

    Full Text Available In 2007 the Association of Research-Based Pharmaceutical Companies (vfa published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: Gebührenordnung für Ärzte by taking into account the actual efforts at the study center.

  8. Present and future breast cancer management--bench to bedside and back: a positioning paper of academia, regulatory authorities and pharmaceutical industry.

    Science.gov (United States)

    Bartsch, R; Frings, S; Marty, M; Awada, A; Berghoff, A S; Conte, P; Dickin, S; Enzmann, H; Gnant, M; Hasmann, M; Hendriks, H R; Llombart, A; Massacesi, C; von Minckwitz, G; Penault-Llorca, F; Scaltriti, M; Yarden, Y; Zwierzina, H; Zielinski, C C

    2014-04-01

    Insights into tumour biology of breast cancer have led the path towards the introduction of targeted treatment approaches; still, breast cancer-related mortality remains relatively high. Efforts in the field of basic research revealed new druggable targets which now await validation within the context of clinical trials. Therefore, questions concerning the optimal design of future studies are becoming even more pertinent. Aspects such as the ideal end point, availability of predictive markers to identify the optimal cohort for drug testing, or potential mechanisms of resistance need to be resolved. An expert panel representing the academic community, the pharmaceutical industry, as well as European Regulatory Authorities met in Vienna, Austria, in November 2012, in order to discuss breast cancer biology, identification of novel biological targets and optimal drug development with the aim of treatment individualization. This article summarizes statements and perspectives provided by the meeting participants.

  9. Design of General-purpose Industrial signal acquisition system in a large scientific device

    Science.gov (United States)

    Ren, Bin; Yang, Lei

    2018-02-01

    In order to measure the industrial signal of a large scientific device experiment, a set of industrial data general-purpose acquisition system has been designed. It can collect 4~20mA current signal and 0~10V voltage signal. Through the practical experiments, it shows that the system is flexible, reliable, convenient and economical, and the system has characters of high definition and strong anti-interference ability. Thus, the system fully meets the design requirements..

  10. Biocatalytic degradation of pharmaceuticals, personal care products, industrial chemicals, steroid hormones and pesticides in a membrane distillation-enzymatic bioreactor.

    Science.gov (United States)

    Asif, Muhammad B; Hai, Faisal I; Kang, Jinguo; van de Merwe, Jason P; Leusch, Frederic D L; Price, William E; Nghiem, Long D

    2018-01-01

    Laccase-catalyzed degradation of a broad spectrum of trace organic contaminants (TrOCs) by a membrane distillation (MD)-enzymatic membrane bioreactor (EMBR) was investigated. The MD component effectively retained TrOCs (94-99%) in the EMBR, facilitating their continuous biocatalytic degradation. Notably, the extent of TrOC degradation was strongly influenced by their molecular properties. A significant degradation (above 90%) of TrOCs containing strong electron donating functional groups (e.g., hydroxyl and amine groups) was achieved, while a moderate removal was observed for TrOCs containing electron withdrawing functional groups (e.g., amide and halogen groups). Separate addition of two redox-mediators, namely syringaldehyde and violuric acid, further improved TrOC degradation by laccase. However, a mixture of both showed a reduced performance for a few pharmaceuticals such as primidone, carbamazepine and ibuprofen. Mediator addition increased the toxicity of the media in the enzymatic bioreactor, but the membrane permeate (i.e., final effluent) was non-toxic, suggesting an added advantage of coupling MD with EMBR. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Combined electrocoagulation and TiO2 photoassisted treatment applied to wastewater effluents from pharmaceutical and cosmetic industries

    International Nuclear Information System (INIS)

    Boroski, Marcela; Rodrigues, Angela Claudia; Garcia, Juliana Carla; Sampaio, Luiz Carlos; Nozaki, Jorge; Hioka, Noboru

    2009-01-01

    The treated wastewater consists of refractory materials and high organic content of hydrolyzed peptone residues from pharmaceutical factory. The combination of electrocoagulation (EC) followed by heterogeneous photocatalysis (TiO 2 ) conditions was maximized. The EC: iron cathode/anode (12.50 cm x 2.50 cm x 0.10 cm), current density 763 A m -2 , 90 min and initial pH 6.0. As EC consequence, the majority of the dissolved organic and suspended material was removed (about 91% and 86% of the turbidity and chemical oxygen demand (COD), respectively). After EC, refractory residues still remained in the effluent. The subsequent photocatalysis: UV/TiO 2 /H 2 O 2 (mercury lamps), pH 3.0, 4 h irradiation, 0.25 g L -1 TiO 2 and 10 mmol L -1 H 2 O 2 shows high levels of inorganic and organic compounds eliminations. The obtained COD values: 1753 mg L -1 for the sample from the factory, 160 mg L -1 after EC and 50 mg L -1 after EC/photocatalyzed effluents pointed out that the combined treatment stresses this water purification

  12. Combined electrocoagulation and TiO{sub 2} photoassisted treatment applied to wastewater effluents from pharmaceutical and cosmetic industries

    Energy Technology Data Exchange (ETDEWEB)

    Boroski, Marcela; Rodrigues, Angela Claudia; Garcia, Juliana Carla; Sampaio, Luiz Carlos; Nozaki, Jorge [Departamento de Quimica, Universidade Estadual de Maringa, Avenida Colombo 5790, Maringa-PR 87020-900 (Brazil); Hioka, Noboru [Departamento de Quimica, Universidade Estadual de Maringa, Avenida Colombo 5790, Maringa-PR 87020-900 (Brazil)], E-mail: nhioka2@yahoo.com.br

    2009-02-15

    The treated wastewater consists of refractory materials and high organic content of hydrolyzed peptone residues from pharmaceutical factory. The combination of electrocoagulation (EC) followed by heterogeneous photocatalysis (TiO{sub 2}) conditions was maximized. The EC: iron cathode/anode (12.50 cm x 2.50 cm x 0.10 cm), current density 763 A m{sup -2}, 90 min and initial pH 6.0. As EC consequence, the majority of the dissolved organic and suspended material was removed (about 91% and 86% of the turbidity and chemical oxygen demand (COD), respectively). After EC, refractory residues still remained in the effluent. The subsequent photocatalysis: UV/TiO{sub 2}/H{sub 2}O{sub 2} (mercury lamps), pH 3.0, 4 h irradiation, 0.25 g L{sup -1} TiO{sub 2} and 10 mmol L{sup -1} H{sub 2}O{sub 2} shows high levels of inorganic and organic compounds eliminations. The obtained COD values: 1753 mg L{sup -1} for the sample from the factory, 160 mg L{sup -1} after EC and 50 mg L{sup -1} after EC/photocatalyzed effluents pointed out that the combined treatment stresses this water purification.

  13. Distribution network design under demand uncertainty using genetic algorithm and Monte Carlo simulation approach: a case study in pharmaceutical industry

    Science.gov (United States)

    Izadi, Arman; Kimiagari, Ali Mohammad

    2014-05-01

    Distribution network design as a strategic decision has long-term effect on tactical and operational supply chain management. In this research, the location-allocation problem is studied under demand uncertainty. The purposes of this study were to specify the optimal number and location of distribution centers and to determine the allocation of customer demands to distribution centers. The main feature of this research is solving the model with unknown demand function which is suitable with the real-world problems. To consider the uncertainty, a set of possible scenarios for customer demands is created based on the Monte Carlo simulation. The coefficient of variation of costs is mentioned as a measure of risk and the most stable structure for firm's distribution network is defined based on the concept of robust optimization. The best structure is identified using genetic algorithms and 14 % reduction in total supply chain costs is the outcome. Moreover, it imposes the least cost variation created by fluctuation in customer demands (such as epidemic diseases outbreak in some areas of the country) to the logistical system. It is noteworthy that this research is done in one of the largest pharmaceutical distribution firms in Iran.

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

    DEFF Research Database (Denmark)

    Sanderson, Hans; Thomsen, Marianne

    2009-01-01

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

  15. PSE in Pharmaceutical Process Development

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  16. Automated Bug Assignment: Ensemble-based Machine Learning in Large Scale Industrial Contexts

    OpenAIRE

    Jonsson, Leif; Borg, Markus; Broman, David; Sandahl, Kristian; Eldh, Sigrid; Runeson, Per

    2016-01-01

    Bug report assignment is an important part of software maintenance. In particular, incorrect assignments of bug reports to development teams can be very expensive in large software development projects. Several studies propose automating bug assignment techniques using machine learning in open source software contexts, but no study exists for large-scale proprietary projects in industry. The goal of this study is to evaluate automated bug assignment techniques that are based on machine learni...

  17. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    Science.gov (United States)

    Modern sanitary practices result in large volumes of human waste, as well as domestic and industrial sewage, being collected and treated at common collection points, wastewater treatment plants (WWTP). In recognition of the growing use of sewage sludges as a fertilizers and as soilamendments, and the scarcity of current data regarding the chemical constituents in sewage sludges, the United States National Research Council (NRC) in 2002 produced a report on sewage sludges. Among the NRC's recommendations was the need for investigating the occurrence of pharmaceuticals and personal care products (PPCPs) in sewage sludges. PPCPsare a diverse array of non-regulated contaminants that had not been studied in previous sewage sludges surveys but which are likely to be present. The focus of this paper will be to review the current analytical methodologies available for investigating whether pharmaceuticals are present in WWTP-produced sewage sludges, to summarize current regulatory practices regarding sewage sludges, and to report on the presence of pharmaceuticals in sewage sludges. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subta

  18. The Holo-Transcriptome of the Zoantharian Protopalythoa variabilis (Cnidaria: Anthozoa: A Plentiful Source of Enzymes for Potential Application in Green Chemistry, Industrial and Pharmaceutical Biotechnology

    Directory of Open Access Journals (Sweden)

    Jean-Étienne R. L. Morlighem

    2018-06-01

    Full Text Available Marine invertebrates, such as sponges, tunicates and cnidarians (zoantharians and scleractinian corals, form functional assemblages, known as holobionts, with numerous microbes. This type of species-specific symbiotic association can be a repository of myriad valuable low molecular weight organic compounds, bioactive peptides and enzymes. The zoantharian Protopalythoa variabilis (Cnidaria: Anthozoa is one such example of a marine holobiont that inhabits the coastal reefs of the tropical Atlantic coast and is an interesting source of secondary metabolites and biologically active polypeptides. In the present study, we analyzed the entire holo-transcriptome of P. variabilis, looking for enzyme precursors expressed in the zoantharian-microbiota assemblage that are potentially useful as industrial biocatalysts and biopharmaceuticals. In addition to hundreds of predicted enzymes that fit into the classes of hydrolases, oxidoreductases and transferases that were found, novel enzyme precursors with multiple activities in single structures and enzymes with incomplete Enzyme Commission numbers were revealed. Our results indicated the predictive expression of thirteen multifunctional enzymes and 694 enzyme sequences with partially characterized activities, distributed in 23 sub-subclasses. These predicted enzyme structures and activities can prospectively be harnessed for applications in diverse areas of industrial and pharmaceutical biotechnology.

  19. How the pill became a lifestyle drug: the pharmaceutical industry and birth control in the United States since 1960.

    Science.gov (United States)

    Watkins, Elizabeth Siegel

    2012-08-01

    Marketing decisions, rather than scientific innovations, have guided the development and positioning of contraceptive products in recent years. I review the stalled progress in contraceptive development in the decades following the advent of the Pill in 1960 and then examine the fine-tuning of the market for oral contraceptives in the 1990s and 2000s. Although birth control has been pitched in the United States as an individual solution, rather than a public health strategy, the purpose of oral contraceptives was understood by manufacturers, physicians, and consumers to be the prevention of pregnancy, a basic health care need for women. Since 1990, the content of that message has changed, reflecting a shift in the drug industry's view of the contraception business. Two factors contributed to bring about this change: first, the industry's move away from research and development in birth control and second, the growth of the class of medications known as lifestyle drugs.

  20. Particle physics and polyedra proximity calculation for hazard simulations in large-scale industrial plants

    Science.gov (United States)

    Plebe, Alice; Grasso, Giorgio

    2016-12-01

    This paper describes a system developed for the simulation of flames inside an open-source 3D computer graphic software, Blender, with the aim of analyzing in virtual reality scenarios of hazards in large-scale industrial plants. The advantages of Blender are of rendering at high resolution the very complex structure of large industrial plants, and of embedding a physical engine based on smoothed particle hydrodynamics. This particle system is used to evolve a simulated fire. The interaction of this fire with the components of the plant is computed using polyhedron separation distance, adopting a Voronoi-based strategy that optimizes the number of feature distance computations. Results on a real oil and gas refining industry are presented.

  1. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres.

    Science.gov (United States)

    van Ommen, Gert-Jan B; Törnwall, Outi; Bréchot, Christian; Dagher, Georges; Galli, Joakim; Hveem, Kristian; Landegren, Ulf; Luchinat, Claudio; Metspalu, Andres; Nilsson, Cecilia; Solesvik, Ove V; Perola, Markus; Litton, Jan-Eric; Zatloukal, Kurt

    2015-07-01

    Biological resources (cells, tissues, bodily fluids or biomolecules) are considered essential raw material for the advancement of health-related biotechnology, for research and development in life sciences, and for ultimately improving human health. Stored in local biobanks, access to the human biological samples and related medical data for transnational research is often limited, in particular for the international life science industry. The recently established pan-European Biobanking and BioMolecular resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC) aims to improve accessibility and interoperability between academic and industrial parties to benefit personalized medicine, disease prevention to promote development of new diagnostics, devices and medicines. BBMRI-ERIC is developing the concept of Expert Centre as public-private partnerships in the precompetitive, not-for-profit field to provide a new structure to perform research projects that would face difficulties under currently established models of academic-industry collaboration. By definition, Expert Centres are key intermediaries between public and private sectors performing the analysis of biological samples under internationally standardized conditions. This paper presents the rationale behind the Expert Centres and illustrates the novel concept with model examples.

  2. A central solar-industrial waste heat heating system with large scale borehole thermal storage

    NARCIS (Netherlands)

    Guo, F.; Yang, X.; Xu, L.; Torrens, I.; Hensen, J.L.M.

    2017-01-01

    In this paper, a new research of seasonal thermal storage is introduced. This study aims to maximize the utilization of renewable energy source and industrial waste heat (IWH) for urban district heating systems in both heating and non-heating seasons through the use of large-scale seasonal thermal

  3. Nanotechnology tools in pharmaceutical R&D

    OpenAIRE

    Challa S.S.R. Kumar

    2010-01-01

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

  4. Study of the Continuous Improvement Trend for Health, Safety and Environmental Indicators, after Establishment of Integrated Management System (IMS) in a Pharmaceutical Industry in Iran.

    Science.gov (United States)

    Mariouryad, Pegah; Golbabaei, Farideh; Nasiri, Parvin; Mohammadfam, Iraj; Marioryad, Hossein

    2015-10-01

    Nowadays, organizations try to improve their services and consequently adopt management systems and standards which have become key parts in various industries. One of these management systems which have been noticed in the recent years is Integrated Management System that is the combination of quality, health, safety and environment management systems. This study was conducted with the aim of evaluating the improvement trend after establishment of integrated management system for health, safety and environment indicators, in a pharmaceutical industry in Iran. First, during several inspections in different parts of the industry, indicators that should have been noted were listed and then these indicators were organized in 3 domains of health, safety and environment in the form of a questionnaire that followed Likert method of scaling. Also, the weight of each index was resulted from averaging out of 30 managers and the viewpoints of the related experts in the field. Moreover, by checking the documents and evidence of different years (5 contemplation years of this study), the score of each indicator was determined by multiplying the weight and score of the indices and were finally analysed. Over 5 years, scores of health scope indicators, increased from 161.99 to 202.23. Score in the first year after applying the integrated management system establishment was 172.37 in safety part and in the final year increased to 197.57. The changes of environmental scope rates, from the beginning of the program up to the last year increased from 49.24 to 64.27. Integrated management systems help organizations to improve programs to achieve their objectives. Although in this study all trends of health, safety and environmental indicator changes were positive, but at the same time showed to be slow. So, one can suggest that the result of an annual evaluation should be applied in planning future activities for the years ahead.

  5. The emerging role of large eddy simulation in industrial practice: challenges and opportunities.

    Science.gov (United States)

    Hutton, A G

    2009-07-28

    That class of methods for treating turbulence gathered under the banner of large eddy simulation is poised to enter mainstream engineering practice. There is a growing body of evidence that such methods offer a significant stretch in industrial capability over solely Reynolds-averaged Navier-Stokes (RANS)-based modelling. A key enabling development will be the adaptation of innovative processor architectures, resulting from the huge investment in the gaming industry, to engineering analysis. This promises to reduce the computational burden to practicable levels. However, there are many lessons to be learned from the history of the past three decades. These lessons should be analysed in order to inform, if not modulate, the unfolding of this next cycle in the development of industrial modelling capability. This provides the theme for this paper, which is written very much from the standpoint of the informed practitioner rather than the innovator; someone with a strong motivation to improve significantly the competence with which industrial turbulent flows are treated. It is asserted that the reliable deployment of the methodology in the industrial context will prove to be a knowledge-based discipline, as was the case with RANS-based modelling, if not more so. The community at large should collectively make great efforts to put in place that knowledge base from which best practice advice can be derived at the very start of this cycle of advancement and continue to enrich it as the cycle progresses.

  6. Normas para la publicación de investigaciones clínicas patrocinadas por la industria farmacéutica Publication standards for clinical research sponsored by the pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    2003-07-01

    Full Text Available The role played by the private sector, in particular the pharmaceutical industry, in funding research has been growing at an accelerated pace in recent decades. So much so, in fact, that the private sector has become the primary funding source of clinical trials in some countries. As a result, pharmaceutical companies exercise ever-growing control over not only the design of clinical trials but also the publication of their results. The conflicts of interest involved in this kind of situation can lead to ethical breaches (for example, suppression or distortion of results or the intimidation of investigators, and it is crucial to take concrete steps to guard against such breaches. This is exactly what a Working Group made up of members of the pharmaceutical industry itself has done, preparing a series of guidelines for that industry in order to promote good publication practices. These guidelines, which were just recently published in English, represent an important step in efforts to achieve greater transparency and accountability in the presentation of results of research funded by manufacturers of pharmaceutical products. Although the guidelines, now translated into Spanish in this piece, are subject to future revisions, they are a valuable starting point for further discussion of a problem that deserves the urgent attention of the scientific community.

  7. Association of medical students' reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study.

    Science.gov (United States)

    Yeh, James S; Austad, Kirsten E; Franklin, Jessica M; Chimonas, Susan; Campbell, Eric G; Avorn, Jerry; Kesselheim, Aaron S

    2014-10-01

    Professional societies use metrics to evaluate medical schools' policies regarding interactions of students and faculty with the pharmaceutical and medical device industries. We compared these metrics and determined which US medical schools' industry interaction policies were associated with student behaviors. Using survey responses from a national sample of 1,610 US medical students, we compared their reported industry interactions with their schools' American Medical Student Association (AMSA) PharmFree Scorecard and average Institute on Medicine as a Profession (IMAP) Conflicts of Interest Policy Database score. We used hierarchical logistic regression models to determine the association between policies and students' gift acceptance, interactions with marketing representatives, and perceived adequacy of faculty-industry separation. We adjusted for year in training, medical school size, and level of US National Institutes of Health (NIH) funding. We used LASSO regression models to identify specific policies associated with the outcomes. We found that IMAP and AMSA scores had similar median values (1.75 [interquartile range 1.50-2.00] versus 1.77 [1.50-2.18], adjusted to compare scores on the same scale). Scores on AMSA and IMAP shared policy dimensions were not closely correlated (gift policies, r = 0.28, 95% CI 0.11-0.44; marketing representative access policies, r = 0.51, 95% CI 0.36-0.63). Students from schools with the most stringent industry interaction policies were less likely to report receiving gifts (AMSA score, odds ratio [OR]: 0.37, 95% CI 0.19-0.72; IMAP score, OR 0.45, 95% CI 0.19-1.04) and less likely to interact with marketing representatives (AMSA score, OR 0.33, 95% CI 0.15-0.69; IMAP score, OR 0.37, 95% CI 0.14-0.95) than students from schools with the lowest ranked policy scores. The association became nonsignificant when fully adjusted for NIH funding level, whereas adjusting for year of education, size of school, and publicly versus

  8. Association of medical students' reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study.

    Directory of Open Access Journals (Sweden)

    James S Yeh

    2014-10-01

    Full Text Available Professional societies use metrics to evaluate medical schools' policies regarding interactions of students and faculty with the pharmaceutical and medical device industries. We compared these metrics and determined which US medical schools' industry interaction policies were associated with student behaviors.Using survey responses from a national sample of 1,610 US medical students, we compared their reported industry interactions with their schools' American Medical Student Association (AMSA PharmFree Scorecard and average Institute on Medicine as a Profession (IMAP Conflicts of Interest Policy Database score. We used hierarchical logistic regression models to determine the association between policies and students' gift acceptance, interactions with marketing representatives, and perceived adequacy of faculty-industry separation. We adjusted for year in training, medical school size, and level of US National Institutes of Health (NIH funding. We used LASSO regression models to identify specific policies associated with the outcomes. We found that IMAP and AMSA scores had similar median values (1.75 [interquartile range 1.50-2.00] versus 1.77 [1.50-2.18], adjusted to compare scores on the same scale. Scores on AMSA and IMAP shared policy dimensions were not closely correlated (gift policies, r = 0.28, 95% CI 0.11-0.44; marketing representative access policies, r = 0.51, 95% CI 0.36-0.63. Students from schools with the most stringent industry interaction policies were less likely to report receiving gifts (AMSA score, odds ratio [OR]: 0.37, 95% CI 0.19-0.72; IMAP score, OR 0.45, 95% CI 0.19-1.04 and less likely to interact with marketing representatives (AMSA score, OR 0.33, 95% CI 0.15-0.69; IMAP score, OR 0.37, 95% CI 0.14-0.95 than students from schools with the lowest ranked policy scores. The association became nonsignificant when fully adjusted for NIH funding level, whereas adjusting for year of education, size of school, and publicly

  9. Assessment of clean development mechanism potential of large-scale energy efficiency measures in heavy industries

    International Nuclear Information System (INIS)

    Hayashi, Daisuke; Krey, Matthias

    2007-01-01

    This paper assesses clean development mechanism (CDM) potential of large-scale energy efficiency measures in selected heavy industries (iron and steel, cement, aluminium, pulp and paper, and ammonia) taking India and Brazil as examples of CDM project host countries. We have chosen two criteria for identification of the CDM potential of each energy efficiency measure: (i) emission reductions volume (in CO 2 e) that can be expected from the measure and (ii) likelihood of the measure passing the additionality test of the CDM Executive Board (EB) when submitted as a proposed CDM project activity. The paper shows that the CDM potential of large-scale energy efficiency measures strongly depends on the project-specific and country-specific context. In particular, technologies for the iron and steel industry (coke dry quenching (CDQ), top pressure recovery turbine (TRT), and basic oxygen furnace (BOF) gas recovery), the aluminium industry (point feeder prebake (PFPB) smelter), and the pulp and paper industry (continuous digester technology) offer promising CDM potential

  10. Biodegradation and reversible inhibitory impact of sulfamethoxazole on the utilization of volatile fatty acids during anaerobic treatment of pharmaceutical industry wastewater

    International Nuclear Information System (INIS)

    Cetecioglu, Zeynep; Ince, Bahar; Gros, Meritxell; Rodriguez-Mozaz, Sara; Barceló, Damia; Ince, Orhan; Orhon, Derin

    2015-01-01

    This study evaluated the chronic impact and biodegradability of sulfamethoxazole under anaerobic conditions. For this purpose, a lab-scale anaerobic sequencing batch reactor was operated in a sequence of different phases with gradually increasing sulfamethoxazole doses of 1 to 45 mg/L. Conventional parameters, such as COD, VFA, and methane generation, were monitored with corresponding antimicrobial concentrations in the reactor and the methanogenic activity of the sludge. The results revealed that anaerobic treatment was suitable for pharmaceutical industry wastewater with concentrations of up to 40 mg/L of sulfamethoxazole. Higher levels exerted toxic effects on the microbial community under anaerobic conditions, causing the inhibition of substrate/COD utilization and biogas generation and leading to a total collapse of the reactor. The adverse long-term impact was quite variable for fermentative bacteria and methanogenic achaea fractions of the microbial community based on changes inflicted on the composition of the residual organic substrate and mRNA expression of the key enzymes. - Highlights: • Chronic impact of sulfamethoxazole was lethal at 45 mg/L on the microbial community. • Sulfamethoxazole was highly biodegradable under anaerobic conditions. • While the COD removal stopped, the sorption of sulfamethoxazole into the sludge increased. • Sulfamethoxazole has a reversible inhibitory effect on acetoclastic methanogens

  11. [The status of occupational health of female migrant workers in traditional Chinese medicine, western medicine and bio-pharmaceutical industry in Gansu province].

    Science.gov (United States)

    Liao, Ping-Tai; Kou, Zhen-Xia; Li, Zhi-Lan; He, Yu-Hong; Yu, Wen-Lan; Zho, An-Shou

    2011-09-01

    To understand the status of occupational health of female migrant workers in different kinds of pharmaceutical industries in Gansu province and to provide the basis for improving occupational health condition. One thousand eight hundreds and one female workers from 16 enterprises were selected by cluster sampling in Gansu province and investigated by interviewing and questionnaires. There were statistical significances of education level, status of residency registrations, employment relationship and occupational hazards among female workers in three types of enterprises (P < 0.05 or P < 0.01). The morbidities of skin disease in female workers for three kinds of enterprises were 4.46%, 2.53% and 3.70%, respectively. The morbidities of reproductive system disease in female workers for three kinds of enterprises were 48.57%, 36.70% and 36.11%, respectively. The levels of education and working conditions of female workers in the traditional Chinese medicine, western medicine plants are low. There are more severe occupational hazards in female workers of the traditional Chinese medicine plants.

  12. Highly invasive alien plant Reynoutria japonica Houtt. represents a novel source for pharmaceutical industry - evidence from phenolic profile and biological activity

    Directory of Open Access Journals (Sweden)

    Božin Biljana

    2017-01-01

    Full Text Available Reynoutria japonica is on the IUCN list of the Worlds’100 worst invasive species, but it is also, especially its rhizome, an integral part of traditional chinese medicine. The objective of this study was to determine the amount of selected phenolic compounds in rhizome, stems, leaves and inflorescence methanol extracts of this plant, their antioxidant and anticholinesterase activity. The chemical profile of the examined extracts was obtained by a high-performance liquid chromatography. In vitro assays on DPPH, OH and NO radicals were used to estimate antioxidant potential and Ellman’s method was applied for the determination of anticholinesterase activity. Leaves and rhizome extracts were found to be rich in rosmarinic and chlorogenic acid, and selected flavonoids. Resveratrol was exclusively present in rhizome and stems extracts. All the investigated extracts expressed certain antioxidant activity, where leaves extract was the most active. However, rhizome extract was the strongest inhibitor of acetylcholinesterase. These findings indicate that there is a possibility of R. japonica exploitation for the isolation of biologically active phenolic compounds used in pharmaceutical and food industry.

  13. Evaluation of New Chemical Entities as Substrates of Liver Transporters in the Pharmaceutical Industry: Response to Regulatory Requirements and Future Steps.

    Science.gov (United States)

    Okudaira, Noriko

    2017-09-01

    This article discusses the evaluation of drug candidates as hepatic transporter substrates. Recently, research on the applications of hepatic transporters in the pharmaceutical industry has improved to meet the requirements of the regulatory guidelines for the evaluation of drug interactions. To identify the risk of transporter-mediated drug-drug interactions at an early stage of drug development, we used a strategy of reviewing the in vivo animal pharmacokinetics and tissue distribution data obtained in the discovery stage together with the in vitro data obtained for regulatory submission. In the context of nonclinical evaluation of new chemical entities as medicines, we believe that transporter studies are emerging as a key strategy to predict their pharmacological and toxicological effects. In combination with the recent progress in systems approaches, the estimation of effective concentrations in the target tissues, by using mathematical models to describe the transporter-mediated distribution and elimination, has enabled us to identify promising compounds for clinical development at the discovery stage. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  14. Biodegradation and reversible inhibitory impact of sulfamethoxazole on the utilization of volatile fatty acids during anaerobic treatment of pharmaceutical industry wastewater

    Energy Technology Data Exchange (ETDEWEB)

    Cetecioglu, Zeynep, E-mail: cetecioglu@itu.edu.tr [Istanbul Technical University, Environmental Engineering Department, 34469 Maslak, Istanbul (Turkey); Catalan Institute for Water Research (ICRA), Emili Grahit 101, 17003 Girona (Spain); Ince, Bahar [Bogazici University, Institute of Environmental Sciences, Rumelihisarustu - Bebek, 34342 Istanbul (Turkey); Gros, Meritxell; Rodriguez-Mozaz, Sara; Barceló, Damia [Catalan Institute for Water Research (ICRA), Emili Grahit 101, 17003 Girona (Spain); Ince, Orhan; Orhon, Derin [Istanbul Technical University, Environmental Engineering Department, 34469 Maslak, Istanbul (Turkey)

    2015-12-01

    This study evaluated the chronic impact and biodegradability of sulfamethoxazole under anaerobic conditions. For this purpose, a lab-scale anaerobic sequencing batch reactor was operated in a sequence of different phases with gradually increasing sulfamethoxazole doses of 1 to 45 mg/L. Conventional parameters, such as COD, VFA, and methane generation, were monitored with corresponding antimicrobial concentrations in the reactor and the methanogenic activity of the sludge. The results revealed that anaerobic treatment was suitable for pharmaceutical industry wastewater with concentrations of up to 40 mg/L of sulfamethoxazole. Higher levels exerted toxic effects on the microbial community under anaerobic conditions, causing the inhibition of substrate/COD utilization and biogas generation and leading to a total collapse of the reactor. The adverse long-term impact was quite variable for fermentative bacteria and methanogenic achaea fractions of the microbial community based on changes inflicted on the composition of the residual organic substrate and mRNA expression of the key enzymes. - Highlights: • Chronic impact of sulfamethoxazole was lethal at 45 mg/L on the microbial community. • Sulfamethoxazole was highly biodegradable under anaerobic conditions. • While the COD removal stopped, the sorption of sulfamethoxazole into the sludge increased. • Sulfamethoxazole has a reversible inhibitory effect on acetoclastic methanogens.

  15. Culture of human mesenchymal stem cells using a candidate pharmaceutical grade xeno-free cell culture supplement derived from industrial human plasma pools.

    Science.gov (United States)

    Díez, José M; Bauman, Ewa; Gajardo, Rodrigo; Jorquera, Juan I

    2015-03-13

    Fetal bovine serum (FBS) is an animal product used as a medium supplement. The animal origin of FBS is a concern if cultured stem cells are to be utilized for human cell therapy. Therefore, a substitute for FBS is desirable. In this study, an industrial, xeno-free, pharmaceutical-grade supplement for cell culture (SCC) under development at Grifols was tested for growth of human mesenchymal stem cells (hMSCs), cell characterization, and differentiation capacity. SCC is a freeze-dried product obtained through cold-ethanol fractionation of industrial human plasma pools from healthy donors. Bone marrow-derived hMSC cell lines were obtained from two commercial suppliers. Cell growth was evaluated by culturing hMSCs with commercial media or media supplemented with SCC or FBS. Cell viability and cell yield were assessed with an automated cell counter. Cell surface markers were studied by indirect immunofluorescence assay. Cells were cultured then differentiated into adipocytes, chondrocytes, osteoblasts, and neurons, as assessed by specific staining and microscopy observation. SCC supported the growth of commercial hMSCs. Starting from the same number of seeded cells in two consecutive passages of culture with medium supplemented with SCC, hMSC yield and cell population doubling time were equivalent to the values obtained with the commercial medium and was consistent among lots. The viability of hMSCs was higher than 90%, while maintaining the characteristic phenotype of undifferentiated hMSCs (positive for CD29, CD44, CD90, CD105, CD146, CD166 and Stro-1; negative for CD14 and CD19). Cultured hMSCs maintained the potential for differentiation into adipocytes, chondrocytes, osteoblasts, and neurons. The tested human plasma-derived SCC sustains the adequate growth of hMSCs, while preserving their differentiation capacity. SCC can be a potential candidate for cell culture supplement in advanced cell therapies.

  16. Giga-Investments: Modelling the Valuation of Very Large Industrial Real Investments

    OpenAIRE

    Collan, Mikael

    2004-01-01

    In this doctoral dissertation characteristics of very large industrial real investments (VLIRI) are investigated and a special group of VLIRI is defined as giga-investments. The investment decision-making regarding to giga-investments is discussed from the points of view of discounted cash-flow based methods and real option valuation. Based on the bacground of establishing giga-investments, state-of-the-art in capital budgeting (including real options) and by applying fuzzy numbers a novel me...

  17. [Reflection on developing bio-energy industry of large oil company].

    Science.gov (United States)

    Sun, Haiyang; Su, Haijia; Tan, Tianwei; Liu, Shumin; Wang, Hui

    2013-03-01

    China's energy supply becomes more serious nowadays and the development of bio-energy becomes a major trend. Large oil companies have superb technology, rich experience and outstanding talent, as well as better sales channels for energy products, which can make full use of their own advantages to achieve the efficient complementary of exist energy and bio-energy. Therefore, large oil companies have the advantages of developing bio-energy. Bio-energy development in China is in the initial stage. There exist some problems such as available land, raw material supply, conversion technologies and policy guarantee, which restrict bio-energy from industrialized development. According to the above key issues, this article proposes suggestions and methods, such as planting energy plant in the marginal barren land to guarantee the supply of bio-energy raw materials, cultivation of professional personnel, building market for bio-energy counting on large oil companies' rich experience and market resources about oil industry, etc, aimed to speed up the industrialized process of bio-energy development in China.

  18. Desafios da química analítica frente às necessidades da indústria farmacêutica Challenges of analytical chemistry in face of the needs of the pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Alberto dos Santos Pereira

    2005-12-01

    Full Text Available The development of liquid chromatography-mass spectrometric (LC-MS techniques in the last few decades has made possible the analysis of trace amounts of analytes from complex matrices. With LC, the analytes of interest can be separated from each other as well as from the interfering matrix, after which they can be reliably identified thanks to the sensitivity and specificity of MS. LC-MS has become an irreplaceable tool for many applications, ranging from the analysis of proteins or pharmaceuticals in biological fluids to the analysis of toxic substances in environmental samples. In different segments of Brazilian Industry mass spectrometry has an important role, e.g. in the pharmaceutical industry in the development of generic formulations, contributing to the growth of Industry and social inclusion. However, the Brazilian chemists until this moment don't have an effective role in this new segment of the analytical chemistry in Brazil. The present paper shows the actual scenario for mass spectrometry in the pharmaceutical industry, emphasizing the need of a revision of graduation courses to attend the needs of this growing market.

  19. Pharmaceutical Raw Material Identification Using Miniature Near-Infrared (MicroNIR) Spectroscopy and Supervised Pattern Recognition Using Support Vector Machine

    OpenAIRE

    Sun, Lan; Hsiung, Chang; Pederson, Christopher G.; Zou, Peng; Smith, Valton; von Gunten, Marc; O?Brien, Nada A.

    2016-01-01

    Near-infrared spectroscopy as a rapid and non-destructive analytical technique offers great advantages for pharmaceutical raw material identification (RMID) to fulfill the quality and safety requirements in pharmaceutical industry. In this study, we demonstrated the use of portable miniature near-infrared (MicroNIR) spectrometers for NIR-based pharmaceutical RMID and solved two challenges in this area, model transferability and large-scale classification, with the aid of support vector machin...

  20. The use of industrial type control and monitoring components for a large fusion experiment

    International Nuclear Information System (INIS)

    Hemming, O.N.; Manduchi, G.; Luchetta, A.; Schmidt, V.; Vitturi, S.

    1994-01-01

    RFX is one of the large nuclear fusion experiments within the framework of the co-ordinated nuclear fusion research programme of the European Community. During the control system design phase in 1986, the increase in power and flexibility of industrial type programmable controllers lead to the decision for a complete physical split of control, monitoring and data acquisition functions according to speed requirements, allowing the exploitation of the relative advantages of both CAMAC and programmable controllers. The 'slow' control and monitoring functions (for about 4000 digital and 200 analog I/O signals with scanning times of similar 1 second) have been implemented using a series of networked industrial PLCs and personal computers. This has allowed us to choose from a wide range of off-the-shelf hardware and software components for the plant interface and to utilize specialized expertise from the industrial field for the application software implementation. The paper gives the expectations and results gained from this design choice and how it has influenced the decisions for the evolution of the system over the next few years with the utilization of new industrial hardware components. Details are also given regarding the system integration (via the Ethernet network) with the VAX-based CAMAC frontend fast control and data-acquisition system. ((orig.))

  1. Complaints, Complainants, and Rulings Regarding Drug Promotion in the United Kingdom and Sweden 2004–2012: A Quantitative and Qualitative Study of Pharmaceutical Industry Self-Regulation

    Science.gov (United States)

    Zetterqvist, Anna V.; Merlo, Juan; Mulinari, Shai

    2015-01-01

    Background In many European countries, medicines promotion is governed by voluntary codes of practice administered by the pharmaceutical industry under its own system of self-regulation. Involvement of industry organizations in policing promotion has been proposed to deter illicit conduct, but few detailed studies on self-regulation have been carried out to date. The objective of this study was to examine the evidence for promotion and self-regulation in the UK and Sweden, two countries frequently cited as examples of effective self-regulation. Methods and Findings We performed a qualitative content analysis of documents outlining the constitutions and procedures of these two systems. We also gathered data from self-regulatory bodies on complaints, complainants, and rulings for the period 2004–2012. The qualitative analysis revealed similarities and differences between the countries. For example, self-regulatory bodies in both countries are required to actively monitor promotional items and impose sanctions on violating companies, but the range of sanctions is greater in the UK where companies may, for instance, be audited or publicly reprimanded. In total, Swedish and UK bodies ruled that 536 and 597 cases, respectively, were in breach, equating to an average of more than one case/week for each country. In Sweden, 430 (47%) complaints resulted from active monitoring, compared with only two complaints (0.2%) in the UK. In both countries, a majority of violations concerned misleading promotion. Charges incurred on companies averaged €447,000 and €765,000 per year in Sweden and the UK, respectively, equivalent to about 0.014% and 0.0051% of annual sales revenues, respectively. One hundred cases in the UK (17% of total cases in breach) and 101 (19%) in Sweden were highlighted as particularly serious. A total of 46 companies were ruled in breach of code for a serious offence at least once in the two countries combined (n = 36 in the UK; n = 27 in Sweden); seven

  2. Pharmaceutical applications of graphene

    Directory of Open Access Journals (Sweden)

    Justyna Żwawiak

    2017-02-01

    Full Text Available Nowadays, dynamic development in nanotechnological sciences is observed. Nanoparticles are frequently used in medicine and pharmacy as delivery systems for different kinds of active substances. One of the latest developed substances, with an unusually wide scope of utility, is graphene. The ways of its use in different fields of industry, not only pharmaceutical and medical, have been a subject of study for many research groups since the moment of its development in 2004. Graphene in pure form is highly hydrophobic. However, the presence of defects on its surface allows chemical modifications to be made, e.g. introduction of oxygen groups by covalent bonding. Also, non-covalent modifications are extensively used, including van der Waals forces, hydrogen bonding, coordination bonds, electrostatic and π-π stacking interactions. Due to the large surface area, graphene can be used in combination therapy, consisting in simultaneous administration of two or more pharmacologically active agents. Another interesting approach is gene therapy. Application of the PEI-graphene oxide system increased the efficacy of transfection. Possibilities of graphene and graphene oxide are not limited to their use as active substance delivery systems. These compounds by themselves were also found to be bacteriostatic and antibacterial agents.

  3. Market profile and conservation opportunity assessment for large industrial operations in Ontario

    International Nuclear Information System (INIS)

    Keyes, C.; Balbaa, I.; Cuthbert, D.; Young, D.

    2006-01-01

    In view of the expected electricity shortages in Ontario, there is an urgent need for not only new supply but also a significant increase in conservation and load shifting efforts. This report presented the results of a study focused on key technology or market areas that presented opportunities for implementation of energy efficient measures. The materials, analytical results, and outcomes of the study could be utilized as a framework for developing future program delivery models. The report provided a comprehensive market analysis for large industrial operations in Ontario. A market profile was presented for the following sectors: mining; pulp and paper; iron and steel; the chemical industry; petroleum refining; motor vehicle, body and parts manufacturing; cement; and food. Opportunities for conservation and demand management were identified. The report also presented an analysis and recommendations for energy conservation demand management and demand response applicable to large industry. Examples of programs in other jurisdictions in Canada as well as the United States were discussed. 34 refs., 7 tabs., 23 figs., 1 appendix.

  4. Biocatalytic Synthesis of Chiral Pharmaceutical Intermediates

    Directory of Open Access Journals (Sweden)

    Ramesh N. Patel

    2004-01-01

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

  5. Supply Chain Management in Zhendong Pharmaceutical Company

    OpenAIRE

    Li, Yan

    2011-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Юрий Владимирович Тарасов

    2014-02-01

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

  7. Saving Energy in Industrial Companies: Case Studies of Energy Efficiency Programs in Large U.S. Industrial Corporations and the Role of Ratepayer-Funded Support

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    2017-03-08

    This paper is designed for companies looking to cut costs through energy savings, ratepayer-funded program administrators interested in increasing large industrial company participation in energy efficiency program offerings, and state utility commissions.

  8. Industrial Technology for Unprecented Energy and Luminosity The Large Hadron Collider

    CERN Document Server

    Lebrun, P

    2004-01-01

    With over 3 billion Swiss francs procurement contracts under execution in industry and the installation of major technical systems in its first 3.3 km sector, the Large Hadron Collider (LHC) construction is now in full swing at CERN, the European Organization for Nuclear Research. The LHC is not only the most challenging particle accelerator, it is also the largest global project ever for a scientific instrument based on advanced technology. Starting from accelerator performance requirements, we recall how these can be met by an appropriate combination of technologies, such as high-field superconducting magnets, superfluid helium cryogenics, power electronics, with particular emphasis on developments required to meet demanding specifications, and industrialization issues which had to be solved for achieving series production of precision components under tight quality assurance and within limited resources. This provides the opportunity for reviewing the production status of the main systems and the progress ...

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

    African Journals Online (AJOL)

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

  10. Comparative standardization study for determination of reserpine in Rauwolfia serpentina homoeopathic mother tinctures manufactured by different pharmaceutical industries using HPTLC as a check for quality control

    Directory of Open Access Journals (Sweden)

    Binit Kumar Dwivedi

    2017-01-01

    Full Text Available Background: Rauwolfia serpentina (L. Benth. ex Kurz (Apocynaceae (Indian snakeroot, popularly known as Sarpagandha (Sanskrit, is used for the treatment of insanity, fever, snake bites, anxiety and in neuropsychiatric conditions. The antihypertensive actions of Reserpine are a result of its ability to deplete catecholamines (amongst other monoamine neurotransmitters from peripheral sympathetic nerve endings which are normally involved in controlling heart rate, force of cardiac contraction and peripheral vascular resistance. Objective: Comparative study of Reserpine content in R. serpentina homoeopathic mother tinctures manufactured by different pharmaceutical industries and in-house mother tinctures applying high-performance thin-layer chromatography investigative techniques to facilitate the use of correct species. Materials and Methods: The authentic samples of roots of R. serpentina were supplied by Centre of Medicinal Plants Research in Homoeopathy, Emerald, Tamil Nadu, India. Authentic plant material was used to prepare the mother tincture (as per Homoeopathic Pharmacopoeia of India. Reserpine (C33H40N2O9,M.P. 360°C, purity >99% w/w by high-performance liquid chromatography [HPLC] was purchased from Sigma-Aldrich as a standard reference. The solvents for the study, namely, ethanol, HPLC water, toluene, ethyl acetate, diethylamine and chloroform were of analytical grade purity (MERCK Ltd.,, used throughout. Results: Five samples of mother tinctures were used for the study, in-house mother tinctures (labelled: D and E of R. serpentina shows a higher amount of Reserpine content than the marketed samples (labelled: A, B and C. Conclusion: It may be concluded that mother tinctures prepared by authentic plants showed the excess amount of Reserpine rather than that of mother tinctures procured from the market.

  11. Internal quality evolution of a large test system – an industrial study

    Directory of Open Access Journals (Sweden)

    Kovács Attila

    2016-12-01

    Full Text Available This paper presents our empirical observations related to the evolution of a large automated test system. The system observed is used in the industry as a test tool for complex telecommunication systems, itself consisting of more than one million lines of source code. This study evaluates how different changes during the development have changed the number of observed Code Smells in the test system. We have monitored the development of the test scripts and measured the code quality characteristics over a five years period.

  12. Development of Conductivity Method as an Alternative to Titration for Hydrolytic Resistance Testing Used for Evaluation of Glass Vials Used in Pharmaceutical Industry.

    Science.gov (United States)

    Fujimori, Kiyoshi; Lee, Hans; Phillips, Joseph; Nashed-Samuel, Yasser

    The European Pharmacopeia surface test to analyze the hydrolytic resistance is a common industrial method to understand and ensure the quality of produced glass vials. Hydrolytic resistance is evaluated by calculating the alkalinity of water extract from autoclaved vials by titration. As an alternative to this titration technique, a conductivity technique was assessed, which directly measures the ions in the water extract. A conductivity meter with a 12 mm diameter electrode was calibrated with a 100 μS/cm conductivity standard and carryover minimized by rinsing the probe in a water beaker per analysis. The limit of quantification at 1 μS/cm was determined as having a signal-to-noise ratio of 3 compared with the water blank. The conductivity method was selective for glass-composing elements (boron, sodium, aluminum, silicon, potassium, and calcium) within the vial extract. Accuracies of spiked conductivity standard within the range of 1 to 100 μS/cm were ±7% and had linearity with coefficient of determination (R 2 ) of ≥0.9999. Intraday precision had a relative standard deviation (RSD) (n = 5) of ≤6% for spiked conductivity standard within the range of 1 to 100 μS/cm. Interday precision had a RSD (n = 4) of ≤6% for 10 vials from three glass vial lots. Conductivity of water extracts from nine sets of seven lots of glass vials had a precise linear relationship [R 2 = 0.9876, RSD = 1% (n = 9)] with titration volumes of the same lots. Conductivity results in μS/cm could be converted to titration volumes in milliliters by a conversion factor of 0.0275. The simplicity, sample stability, and individual vial analysis of the conductivity technique were more advantageous than the current titration technique. The quality of glass vials used as primary containers in the pharmaceutical industry is of concern due to recent observations of glass flake-like delamination, or lamellae, under specific storage conditions. The current European Pharmacopoeia method to assess

  13. Capitated chronic disease management programs: a new market for pharmaceutical companies.

    Science.gov (United States)

    Cave, D G

    1995-01-01

    With corporatism of the medical care delivery system, the pharmaceutical industry is searching for new ways to market prescription drug product lines. A new strategy focuses on developing chronic disease management programs. In doing so, pharmaceutical companies work with clinical leaders of HMOs or large physician groups on disease management guidelines to reduce practice pattern variations and improve the quality of patient care. In addition, pharmaceutical companies capitate payment to physicians treating chronic disease patients to give them financial incentives to comply with the disease management guidelines.

  14. Large eddy simulation of flows in industrial compressors: a path from 2015 to 2035

    Science.gov (United States)

    Gourdain, N.; Sicot, F.; Duchaine, F.; Gicquel, L.

    2014-01-01

    A better understanding of turbulent unsteady flows is a necessary step towards a breakthrough in the design of modern compressors. Owing to high Reynolds numbers and very complex geometry, the flow that develops in such industrial machines is extremely hard to predict. At this time, the most popular method to simulate these flows is still based on a Reynolds-averaged Navier–Stokes approach. However, there is some evidence that this formalism is not accurate for these components, especially when a description of time-dependent turbulent flows is desired. With the increase in computing power, large eddy simulation (LES) emerges as a promising technique to improve both knowledge of complex physics and reliability of flow solver predictions. The objective of the paper is thus to give an overview of the current status of LES for industrial compressor flows as well as to propose future research axes regarding the use of LES for compressor design. While the use of wall-resolved LES for industrial multistage compressors at realistic Reynolds number should not be ready before 2035, some possibilities exist to reduce the cost of LES, such as wall modelling and the adaptation of the phase-lag condition. This paper also points out the necessity to combine LES to techniques able to tackle complex geometries. Indeed LES alone, i.e. without prior knowledge of such flows for grid construction or the prohibitive yet ideal use of fully homogeneous meshes to predict compressor flows, is quite limited today. PMID:25024422

  15. Large eddy simulations of isothermal confined swirling flow in an industrial gas-turbine

    International Nuclear Information System (INIS)

    Bulat, G.; Jones, W.P.; Navarro-Martinez, S.

    2015-01-01

    Highlights: • We conduct a large eddy simulation of an industrial gas turbine. • The results are compared with measurements obtained under isothermal conditions. • The method reproduces the observed precessing vortex and central vortex cores. • The profiles of mean and rms velocities are found to be captured to a good accuracy. - Abstract: The paper describes the results of a computational study of the strongly swirling isothermal flow in the combustion chamber of an industrial gas turbine. The flow field characteristics are computed using large eddy simulation in conjunction with a dynamic version of the Smagorinsky model for the sub-grid-scale stresses. Grid refinement studies demonstrate that the results are essentially grid independent. The LES results are compared with an extensive set of measurements and the agreement with these is overall good. The method is shown to be capable of reproducing the observed precessing vortex and central vortex cores and the profiles of mean and rms velocities are found to be captured to a good accuracy. The overall flow structure is shown to be virtually independent of Reynolds number

  16. The large-scale process of microbial carbonate precipitation for nickel remediation from an industrial soil.

    Science.gov (United States)

    Zhu, Xuejiao; Li, Weila; Zhan, Lu; Huang, Minsheng; Zhang, Qiuzhuo; Achal, Varenyam

    2016-12-01

    Microbial carbonate precipitation is known as an efficient process for the remediation of heavy metals from contaminated soils. In the present study, a urease positive bacterial isolate, identified as Bacillus cereus NS4 through 16S rDNA sequencing, was utilized on a large scale to remove nickel from industrial soil contaminated by the battery industry. The soil was highly contaminated with an initial total nickel concentration of approximately 900 mg kg -1 . The soluble-exchangeable fraction was reduced to 38 mg kg -1 after treatment. The primary objective of metal stabilization was achieved by reducing the bioavailability through immobilizing the nickel in the urease-driven carbonate precipitation. The nickel removal in the soils contributed to the transformation of nickel from mobile species into stable biominerals identified as calcite, vaterite, aragonite and nickelous carbonate when analyzed under XRD. It was proven that during precipitation of calcite, Ni 2+ with an ion radius close to Ca 2+ was incorporated into the CaCO 3 crystal. The biominerals were also characterized by using SEM-EDS to observe the crystal shape and Raman-FTIR spectroscopy to predict responsible bonding during bioremediation with respect to Ni immobilization. The electronic structure and chemical-state information of the detected elements during MICP bioremediation process was studied by XPS. This is the first study in which microbial carbonate precipitation was used for the large-scale remediation of metal-contaminated industrial soil. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Entrepreneurial patent management in pharmaceutical startups.

    Science.gov (United States)

    Holgersson, Marcus; Phan, Tai; Hedner, Thomas

    2016-07-01

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

  18. 78 FR 58315 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2013-09-23

    ...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... continuous manufacturing for pharmaceutical products. Speakers from the Agency, academia, and industry will...

  19. Drivers and barriers to e-invoicing adoption in Greek large scale manufacturing industries

    Energy Technology Data Exchange (ETDEWEB)

    Marinagi, Catherine, E-mail: marinagi@teihal.gr, E-mail: ptrivel@yahoo.com, E-mail: preklitis@yahoo.com; Trivellas, Panagiotis, E-mail: marinagi@teihal.gr, E-mail: ptrivel@yahoo.com, E-mail: preklitis@yahoo.com; Reklitis, Panagiotis, E-mail: marinagi@teihal.gr, E-mail: ptrivel@yahoo.com, E-mail: preklitis@yahoo.com [Technological Educational Institute of Sterea Ellada, Department of Logistics management, 1st km of Old National Road Thiva-Elefsis-32200, Thiva (Greece); Skourlas, Christos, E-mail: cskourlas@teiath.gr [Technological Educational Institute of Athens, Department of Informatics, Ag. Spyridonos, Aigaleo-12210, Athens (Greece)

    2015-02-09

    This paper attempts to investigate the drivers and barriers that large-scale Greek manufacturing industries experience in adopting electronic invoices (e-invoices), based on three case studies with organizations having international presence in many countries. The study focuses on the drivers that may affect the increase of the adoption and use of e-invoicing, including the customers demand for e-invoices, and sufficient know-how and adoption of e-invoicing in organizations. In addition, the study reveals important barriers that prevent the expansion of e-invoicing, such as suppliers’ reluctance to implement e-invoicing, and IT infrastructures incompatibilities. Other issues examined by this study include the observed benefits from e-invoicing implementation, and the financial priorities of the organizations assumed to be supported by e-invoicing.

  20. Progress in Root Cause and Fault Propagation Analysis of Large-Scale Industrial Processes

    Directory of Open Access Journals (Sweden)

    Fan Yang

    2012-01-01

    Full Text Available In large-scale industrial processes, a fault can easily propagate between process units due to the interconnections of material and information flows. Thus the problem of fault detection and isolation for these processes is more concerned about the root cause and fault propagation before applying quantitative methods in local models. Process topology and causality, as the key features of the process description, need to be captured from process knowledge and process data. The modelling methods from these two aspects are overviewed in this paper. From process knowledge, structural equation modelling, various causal graphs, rule-based models, and ontological models are summarized. From process data, cross-correlation analysis, Granger causality and its extensions, frequency domain methods, information-theoretical methods, and Bayesian nets are introduced. Based on these models, inference methods are discussed to find root causes and fault propagation paths under abnormal situations. Some future work is proposed in the end.

  1. Drivers and barriers to e-invoicing adoption in Greek large scale manufacturing industries

    International Nuclear Information System (INIS)

    Marinagi, Catherine; Trivellas, Panagiotis; Reklitis, Panagiotis; Skourlas, Christos

    2015-01-01

    This paper attempts to investigate the drivers and barriers that large-scale Greek manufacturing industries experience in adopting electronic invoices (e-invoices), based on three case studies with organizations having international presence in many countries. The study focuses on the drivers that may affect the increase of the adoption and use of e-invoicing, including the customers demand for e-invoices, and sufficient know-how and adoption of e-invoicing in organizations. In addition, the study reveals important barriers that prevent the expansion of e-invoicing, such as suppliers’ reluctance to implement e-invoicing, and IT infrastructures incompatibilities. Other issues examined by this study include the observed benefits from e-invoicing implementation, and the financial priorities of the organizations assumed to be supported by e-invoicing

  2. Ethical pharmaceutical promotion and communications worldwide: codes and regulations

    Science.gov (United States)

    2014-01-01

    The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice. Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines. PMID:24679064

  3. Idea management in support of pharmaceutical front end innovation

    DEFF Research Database (Denmark)

    Aagaard, Annabeth

    2012-01-01

    The pharmaceutical industry faces continuing pressures from rising R&D costs and depreciating value of patents, as patent lives is eroded by testing procedures and pressures from public authorities to cut health care costs. These challenges have increased the focus on shortening development times......, which again put pressure on the efficiency of front end innovation (FEI). In the attempt to overcome these various challenges pharmaceutical companies are looking for new models to support FEI. This paper explores in what way idea management can be applied as a tool in facilitation of front end...... innovation in practice. First I show through a literature study, how idea management and front end innovation are related and may support each other. Hereafter I apply an exploratory case study of front end innovation in eight medium to large pharmaceutical companies in examination of how idea management...

  4. Ethical pharmaceutical promotion and communications worldwide: codes and regulations.

    Science.gov (United States)

    Francer, Jeffrey; Izquierdo, Jose Zamarriego; Music, Tamara; Narsai, Kirti; Nikidis, Chrisoula; Simmonds, Heather; Woods, Paul

    2014-03-29

    The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines.

  5. ANALYSIS OF SCIENTIFIC RESEARCHES IN PHARMACEUTICAL PROMOTION GLOBALLY: TOWARDS INTERNATIONALLY DEVELOPING PRACTICALLY-ORIENTED GUIDELINES FOR PHARMACEUTICAL COMPANIES

    Directory of Open Access Journals (Sweden)

    M. M. Bahlol

    2016-01-01

    Full Text Available Purpose. Pharmaceutical industry is transnational and globally important. Many pharmaceutical companies operate their business in multinational and international forms in different countries. Diverse researches from different countries indicated and confirmed marketing promotion importance in pharmaceutical field. Therefore, marketing promotion and its effects are a very important issue that should be globally investigated in real life and evidence context. We oriented our research according to these scientific and practical values.Methodology. We reviewed pharmaceutical marketing promotion researches from more than 25 different countries, e.g., USA, Canada, Italy, France, Russia, India, Egypt and Syria where we employed our knowledge of three widely spread languages, i.e., English, Russian and Arabic. Such language variation supports us with large and variable amount of scientific knowledge, deep understanding and ability of analysis. Some studies investigated average response to pharmaceutical marketing promotion and few studies took into consideration heterogeneity in their effects with respect to advertising medium or drug characteristics.Originality. We investigated empirical evidences of pharmaceutical marketing promotion that can be directed to either consumer or healthcare professionals.Findings. We extracted, gathered and associated information of pharmaceutical promotion globally which oriented us to several evidence and practical facts with regard to employing promotion tools in different definite situations pertinent to main directions; their welfare and health enhancing effects and adverse effects. Practical Implications- Consequently, we developed practically-oriented guidelines for companies concerning pharmaceutical promotion globally ate the end of this paper.

  6. Introduction: Institutional corruption and the pharmaceutical policy.

    Science.gov (United States)

    Rodwin, Marc A

    2013-01-01

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

  7. In Silico Absorption, Distribution, Metabolism, Excretion, and Pharmacokinetics (ADME-PK): Utility and Best Practices. An Industry Perspective from the International Consortium for Innovation through Quality in Pharmaceutical Development.

    Science.gov (United States)

    Lombardo, Franco; Desai, Prashant V; Arimoto, Rieko; Desino, Kelly E; Fischer, Holger; Keefer, Christopher E; Petersson, Carl; Winiwarter, Susanne; Broccatelli, Fabio

    2017-11-22

    In silico tools to investigate absorption, distribution, metabolism, excretion, and pharmacokinetics (ADME-PK) properties of new chemical entities are an integral part of the current industrial drug discovery paradigm. While many companies are active in the field, scientists engaged in this area do not necessarily share the same background and have limited resources when seeking guidance on how to initiate and maintain an in silico ADME-PK infrastructure in an industrial setting. This work summarizes the views of a group of industrial in silico and experimental ADME scientists, participating in the In Silico ADME Working Group, a subgroup of the International Consortium for Innovation through Quality in Pharmaceutical Development (IQ) Drug Metabolism Leadership Group. This overview on the benefits, caveats, and impact of in silico ADME-PK should serve as a resource for medicinal chemists, computational chemists, and DMPK scientists working in drug design to increase their knowledge in the area.

  8. New insights into liquid chromatography for more eco-friendly analysis of pharmaceuticals.

    Science.gov (United States)

    Shaaban, Heba

    2016-10-01

    Greening the analytical methods used for analysis of pharmaceuticals has been receiving great interest aimed at eliminating or minimizing the amount of organic solvents consumed daily worldwide without loss in chromatographic performance. Traditional analytical LC techniques employed in pharmaceutical analysis consume tremendous amounts of hazardous solvents and consequently generate large amounts of waste. The monetary and ecological impact of using large amounts of solvents and waste disposal motivated the analytical community to search for alternatives to replace polluting analytical methodologies with clean ones. In this context, implementing the principles of green analytical chemistry (GAC) in analytical laboratories is highly desired. This review gives a comprehensive overview on different green LC pathways for implementing GAC principles in analytical laboratories and focuses on evaluating the greenness of LC analytical procedures. This review presents green LC approaches for eco-friendly analysis of pharmaceuticals in industrial, biological, and environmental matrices. Graphical Abstract Green pathways of liquid chromatography for more eco-friendly analysis of pharmaceuticals.

  9. [PICS: pharmaceutical inspection cooperation scheme].

    Science.gov (United States)

    Morénas, J

    2009-01-01

    The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry.

  10. Method for manufacturing carrier containing e.g. proteins for human during oral drug delivery operation for food and drug administration application in pharmaceutical industry, involves providing active ingredient to core layer

    DEFF Research Database (Denmark)

    2015-01-01

    NOVELTY - The method involves preparing a multi-layered film comprising a core layer and a barrier layer, where the core layer comprises active ingredient. The multi-layered film is subjected to a hot embossing step using an embossing stamp including protrusions that allows for generation...... delivery operation for a food and drug administration (FDA) application in a pharmaceutical industry. ADVANTAGE - The method enables allowing an individual micro-structure stuck in an embossing stamp to be demolded under the conditions such that demolding operation is done by treating elastically...

  11. Heat pump applications in utility centres for large industrial areas in the Netherlands

    NARCIS (Netherlands)

    Wit, J.B. de

    1999-01-01

    A grand design for industrial waste heat utilisation has been composed in Rijnmond Industrial Area, the largest (petrochemical) industrial area in The Netherlands. In combination with local CHP plants, an HP, MP and LP steam exchange system has been developed. The primary energy savings of this

  12. Inter-firm R&D partnering in pharmaceutical biotechnology since 1975 : trends, patterns, and networks

    NARCIS (Netherlands)

    Roijakkers, A.H.W.M.; Hagedoorn, J.

    2006-01-01

    This paper analyses a large, longitudinal database on inter-firm R&D partnerships formed in the high-tech pharmaceutical biotechnology industry since 1975. Our research indicates an overall growth in the number of annually, newly established R&D partnerships where research partners consistently

  13. Drivers of peak sales for pharmaceutical brands

    NARCIS (Netherlands)

    Fischer, Marc; Leeflang, Peter S. H.; Verhoef, Peter C.

    2010-01-01

    Peak sales are an important metric in the pharmaceutical industry. Specifically, managers are focused on the height-of-peak-sales and the time required achieving peak sales. We analyze how order of entry and quality affect the level of peak sales and the time-to-peak-sales of pharmaceutical brands.

  14. Análise comparativa da concentração industrial e de turnover da indústria farmacêutica no Brasil para os segmentos de medicamentos de marca e genéricos Comparative analysis of the Industrial Concentration and Turnover of the pharmaceutical industry in Brazil for the segments of mark and generic drugs

    Directory of Open Access Journals (Sweden)

    Gerson Rosenberg

    2010-04-01

    Full Text Available Este artigo analisa a evolução da estrutura do segmento de medicamentos de marca e genéricos no Brasil a partir de 1997. Após a entrada dos medicamentos genéricos, constatou-se que não houve diminuição significativa da concentração na indústria farmacêutica brasileira, porém, o mesmo não ocorreu em nível mundial, verificando-se um aumento da concentração a partir de 2001, impulsionado pelo expressivo processo de fusões e aquisições nos últimos anos da década de 1990. Em relação ao turnover, notou-se que este foi muito baixo para o grupo das maiores empresas em ambos os segmentos de medicamentos. Entretanto, observa-se um elevado turnover com a entrada dos genéricos, mostrando o fortalecimento da indústria nacional. Verifica-se que o processo de fusões e aquisições entre empresas nacionais é pouco significativo, o que pode ser uma alternativa para as pequenas empresas farmacêuticas aumentarem a sua participação no mercado brasileiro.This paper analyzes the evolution of brand-name and generic drugs structure in Brazil since 1997. After the introduction of generic drugs it was not verified a significant decrease in the concentration of Brazilian pharmaceutical industry. The process of mergers and acquisitions in the 90's enhanced the process of concentration in the international market. However, a non-expressive turnover can be demonstrated in both pharmaceutical and generic markets. At the same time, the entrance of the generic industry in Brazil explains the invigoration of the national industry. The mergers and acquisitions process in the pharmaceutical industry is quite intense in Europe and in the USA, although in Brazil it is still not significant.

  15. Large-Scale Selection and Breeding To Generate Industrial Yeasts with Superior Aroma Production

    Science.gov (United States)

    Steensels, Jan; Meersman, Esther; Snoek, Tim; Saels, Veerle

    2014-01-01

    The concentrations and relative ratios of various aroma compounds produced by fermenting yeast cells are essential for the sensory quality of many fermented foods, including beer, bread, wine, and sake. Since the production of these aroma-active compounds varies highly among different yeast strains, careful selection of variants with optimal aromatic profiles is of crucial importance for a high-quality end product. This study evaluates the production of different aroma-active compounds in 301 different Saccharomyces cerevisiae, Saccharomyces paradoxus, and Saccharomyces pastorianus yeast strains. Our results show that the production of key aroma compounds like isoamyl acetate and ethyl acetate varies by an order of magnitude between natural yeasts, with the concentrations of some compounds showing significant positive correlation, whereas others vary independently. Targeted hybridization of some of the best aroma-producing strains yielded 46 intraspecific hybrids, of which some show a distinct heterosis (hybrid vigor) effect and produce up to 45% more isoamyl acetate than the best parental strains while retaining their overall fermentation performance. Together, our results demonstrate the potential of large-scale outbreeding to obtain superior industrial yeasts that are directly applicable for commercial use. PMID:25192996

  16. Experience with LHC Magnets from Prototyping to Large Scale Industrial Production and Integration

    CERN Multimedia

    Rossi, L

    2004-01-01

    The construction of the LHC superconducting magnets is approaching its half way to completion. At the end of 2003, main dipoles cold masses for more than one octant were delivered; meanwhile the winding for the second octant was almost completed. The other large magnets, like the main quadrupoles and the insertion quadrupoles, have entered into series production as well. Providing more than 20 km of superconducting magnets, with the quality required for an accelerator like LHC, is an unprecedented challenge in term of complexity that has required many steps from the construction of 1 meterlong magnets in the laboratory to today’s production of more than one 15 meter-long magnet per day in Industry. The work and its organization is made even more complex by the fact that CERN supplies most of the critical components and part of the main tooling to the magnet manufacturers, both for cost reduction and for quality issues. In this paper the critical aspects of the construction will be reviewed and the actual ...

  17. Pooling knowledge and improving safety for contracted works at a large industrial park.

    Science.gov (United States)

    Agnello, Patrizia; Ansaldi, Silvia; Bragatto, Paolo

    2015-01-01

    At a large chemical park maintenance is contracted by the major companies operating the plants to many small firms. The cultural and psychological isolation of contractor workers was recognized a root cause of severe accidents in the recent years. That problem is common in chemical industry. The knowledge sharing has been assumed a good key to involve contractors and sub contractors in safety culture and contributing to injuries prevention. The selection of personal protective equipment PPE for the maintenance works has been taken as benchmark to demonstrate the adequateness of the proposed approach. To support plant operators, contractors and subcontractors in PPE discussion, a method has been developed. Its core is a knowledge-base, organized in an Ontology, as suitable for inferring decisions. By means of this tool all stakeholders have merged experience and information and find out the right PPE, to be provided, with adequate training and information package. PPE selection requires sound competencies about process and environmental hazards, including major accident, preventive and protective measures, maintenance activities. These pieces of knowledge previously fragmented among plant operators and contractors, have to be pooled, and used to find out the adequate PPE for a number of maintenance works. The PPE selection is per se important, but it is also a good chance to break the contractors' isolation and involve them in safety objectives. Thus by pooling experience and practical knowledge, the common understanding of safety issues has been strengthened.

  18. Carbon dioxide recycling: emerging large-scale technologies with industrial potential.

    Science.gov (United States)

    Quadrelli, Elsje Alessandra; Centi, Gabriele; Duplan, Jean-Luc; Perathoner, Siglinda

    2011-09-19

    This Review introduces this special issue of ChemSusChem dedicated to CO(2) recycling. Its aim is to offer an up-to-date overview of CO(2) chemical utilization (inorganic mineralization, organic carboxylation, reduction reactions, and biochemical conversion), as a continuation and extension of earlier books and reviews on this topic, but with a specific focus on large-volume routes and projects/pilot plants that are currently emerging at (pre-)industrial level. The Review also highlights how some of these routes will offer a valuable opportunity to introduce renewable energy into the existing energy and chemical infrastructure (i.e., "drop-in" renewable energy) by synthesis of chemicals from CO(2) that are easy to transport and store. CO(2) conversion therefore has the potential to become a key pillar of the sustainable and resource-efficient production of chemicals and energy from renewables. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  19. Production of highly efficient activated carbons from industrial wastes for the removal of pharmaceuticals from water-A full factorial design.

    Science.gov (United States)

    Jaria, Guilaine; Silva, Carla Patrícia; Oliveira, João A B P; Santos, Sérgio M; Gil, María Victoria; Otero, Marta; Calisto, Vânia; Esteves, Valdemar I

    2018-02-26

    The wide occurrence of pharmaceuticals in aquatic environments urges the development of cost-effective solutions for their removal from water. In a circular economy context, primary paper mill sludge (PS) was used to produce activated carbon (AC) aiming the adsorptive removal of these contaminants. The use of low-cost precursors for the preparation of ACs capable of competing with commercial ACs continues to be a challenge. A full factorial design of four factors (pyrolysis temperature, residence time, precursor/activating agent ratio, and type of activating agent) at two levels was applied to the production of AC using PS as precursor. The responses analysed were the yield of production, percentage of adsorption for three pharmaceuticals (sulfamethoxazole, carbamazepine, and paroxetine), specific surface area (S BET ), and total organic carbon (TOC). Statistical analysis was performed to evaluate influencing factors in the responses and to determine the most favourable production conditions. Four ACs presented very good responses, namely on the adsorption of the pharmaceuticals under study (average adsorption percentage around 78%, which is above that of commercial AC), and S BET between 1389 and 1627 m 2  g -1 . A desirability analysis pointed out 800 °C for 60 min and a precursor/KOH ratio of 1:1 (w/w) as the optimal production conditions. Copyright © 2018 Elsevier B.V. All rights reserved.

  20. Industry

    International Nuclear Information System (INIS)

    Schindler, I.; Wiesenberger, H.

    2001-01-01

    This chapter of the environmental control report deals with the environmental impact of the industry in Austria. It gives a review of the structure and types of the industry, the legal framework and environmental policy of industrial relevance. The environmental situation of the industry in Austria is analyzed in detail, concerning air pollution (SO 2 , NO x , CO 2 , CO, CH 4 , N 2 O, NH 3 , Pb, Cd, Hg, dioxin, furans), waste water, waste management and deposit, energy and water consumption. The state of the art in respect of the IPPC-directives (European Integrated Pollution Prevention and Control Bureau) concerning the best available techniques of the different industry sectors is outlined. The application of European laws and regulations in the Austrian industry is described. (a.n.)

  1. Coordinated research project on radiation sterilization and decontamination of pharmaceuticals and pharmaceutical raw materials. CRP report

    International Nuclear Information System (INIS)

    2005-01-01

    Radiation processing is a very convenient tool for imparting desirable effects in materials and it has been an area of enormous interest in the last few decades. Radiation processing of synthetic and natural polymers for improving their characteristics is largely used in laboratory and industrial scale. Radiation sterilization is a well developed and established technology for many products. It is especially useful for the treatment of pharmaceuticals due to flexibility of radiation processing to be carried out at any desired temperature, sterilizability of mixed products in kits, offering simultaneous sterilization and modification of polymer based formulations. The success of radiation technology for processing of synthetic and natural polymers and treatment of pharmaceuticals has been based, to a large extent, on empirical knowledge. But now, the applications of natural polymers are being sought in knowledge-demanding areas such as pharmacy and biotechnology. Reliable analytical methods are being developed for controlling of degradation effects of radiation on polymers. Procedures and chemical formulations are being investigated enhancing or preventing degradation effects depending on the desired application of the process. The Coordinated Research Project (CRP) on the use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials has been completed in 2002. The overall objective of the CRP was to coordinate the research and development programmes carried out in different countries in use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutic raw materials. It has been concluded that in addition to well known advantages of radiation sterilization being a well developed and established technology requiring the control of only one parameter, dose, to achieve sterilization; it is especially useful for the treatment of pharmaceuticals due to flexibility of radiation

  2. Coordinated research project on radiation sterilization and decontamination of pharmaceuticals and pharmaceutical raw materials. CRP report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2005-07-01

    Radiation processing is a very convenient tool for imparting desirable effects in materials and it has been an area of enormous interest in the last few decades. Radiation processing of synthetic and natural polymers for improving their characteristics is largely used in laboratory and industrial scale. Radiation sterilization is a well developed and established technology for many products. It is especially useful for the treatment of pharmaceuticals due to flexibility of radiation processing to be carried out at any desired temperature, sterilizability of mixed products in kits, offering simultaneous sterilization and modification of polymer based formulations. The success of radiation technology for processing of synthetic and natural polymers and treatment of pharmaceuticals has been based, to a large extent, on empirical knowledge. But now, the applications of natural polymers are being sought in knowledge-demanding areas such as pharmacy and biotechnology. Reliable analytical methods are being developed for controlling of degradation effects of radiation on polymers. Procedures and chemical formulations are being investigated enhancing or preventing degradation effects depending on the desired application of the process. The Coordinated Research Project (CRP) on the use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials has been completed in 2002. The overall objective of the CRP was to coordinate the research and development programmes carried out in different countries in use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutic raw materials. It has been concluded that in addition to well known advantages of radiation sterilization being a well developed and established technology requiring the control of only one parameter, dose, to achieve sterilization; it is especially useful for the treatment of pharmaceuticals due to flexibility of radiation

  3. Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease

    DEFF Research Database (Denmark)

    Jones, Roy; Wilkinson, David; Lopez, Oscar L

    2011-01-01

    Large clinical trials databases, developed over the course of a comprehensive clinical trial programme, represent an invaluable resource for clinical researchers. Data mining projects sponsored by industry that use these databases, however, are often not viewed favourably in the academic medical...... community because of concerns that commercial, rather than scientific, goals are the primary purpose of such endeavours. Thus, there are few examples of sustained collaboration between leading academic clinical researchers and industry professionals in a large-scale data mining project. We present here...

  4. Pharmaceutical powder compaction technology

    National Research Council Canada - National Science Library

    Çelik, Metin

    2011-01-01

    "Revised to reflect modern pharmaceutical compacting techniques, this Second Edition guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel...

  5. Thermal performance assessment of a large aperture concentrating collector in an industrial application in Chile

    Science.gov (United States)

    Murray, Clare; Pino, Alan; Cardemil, José Miguel; Escobar, Rodrigo

    2017-06-01

    The application of solar thermal energy to meet the heat demands of the food and beverage processing industry in Chile has huge potential. This paper presents an assessment of the first large aperture trough collector installed in Latin America. The collector preheats water for a boiler in a juice-concentrating factory, 100 km north of Santiago. An analysis of the system for a day in November indicates the system was not able to utilize the heat generated, resulting in rapid de- and refocusing of the collector and problems with sensor calibration. An analysis of a day in March indicates the tracking algorithm has not correctly aligned the collector with the sun's position. An investigation into the design document reveals that the meteorological data underestimates the actual irradiation values by 40%, resulting in an oversized system given the actual conditions. To increase the energy gain in the system it is proposed to increase the working pressure from the current value of 1.5bar to up to 5bar, which could increase the system utilization from 41% to 65% and reduce the dumped energy to near zero. The simulation results with actual weather data and a fixed inlet temperature indicate the annual solar fraction could increase from the design value of 8.1% to 31.8% with a working pressure of 5 bar. The plant presents multiple opportunities for improvement not only to the performance of the plant but also in the design and installation of solar thermal systems in Chile in the future.

  6. WATER QUALITY MONITORING OF PHARMACEUTICALS ...

    Science.gov (United States)

    The demand on freshwater to sustain the needs of the growing population is of worldwide concern. Often this water is used, treated, and released for reuse by other communities. The anthropogenic contaminants present in this water may include complex mixtures of pesticides, prescription and nonprescription drugs, personal care and common consumer products, industrial and domestic-use materials and degradation products of these compounds. Although, the fate of these pharmaceuticals and personal care products (PPCPs) in wastewater treatment facilities is largely unknown, the limited data that does exist suggests that many of these chemicals survive treatment and some others are returned to their biologically active form via deconjugation of metabolites.Traditional water sampling methods (i.e., grab or composite samples) often require the concentration of large amounts of water to detect trace levels of PPCPs. A passive sampler, the polar organic chemical integrative sampler (POCIS), has been developed to integratively concentrate the trace levels of these chemicals, determine the time-weighted average water concentrations, and provide a method of estimating the potential exposure of aquatic organisms to these complex mixtures of waterborne contaminants. The POCIS (U.S. Patent number 6,478,961) consists of a hydrophilic microporous membrane, acting as a semipermeable barrier, enveloping various solid-phase sorbents that retain the sampled chemicals. Sampling rates f

  7. Analysis on Potential of Electric Energy Market based on Large Industrial Consumer

    Science.gov (United States)

    Lin, Jingyi; Zhu, Xinzhi; Yang, Shuo; Xia, Huaijian; Yang, Di; Li, Hao; Lin, Haiying

    2018-01-01

    The implementation of electric energy substitution by enterprises plays an important role in promoting the development of energy conservation and emission reduction in china. In order to explore alternative energy potential of industrial enterprises, to simulate and analyze the process of industrial enterprises, identify high energy consumption process and equipment, give priority to alternative energy technologies, and determine the enterprise electric energy substitution potential predictive value, this paper constructs the evaluation model of the influence factors of the electric energy substitution potential of industrial enterprises, and uses the combined weight method to determine the weight value of the evaluation factors to calculate the target value of the electric energy substitution potential. Taking the iron and steel industry as an example, this method is used to excavate the potential. The results show that the method can effectively tap the potential of the electric power industry

  8. Incentivos y desincentivos de la industria farmacéutica privada para la I+D de nuevos medicamentos Incentives and disincentives for research and development of new drugs by the pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Pasqualina Curcio Curcio

    2008-10-01

    Full Text Available En el trabajo se desarrolló un modelo con los factores que influyen sobre la decisión de I+D de la industria farmacéutica. Los factores son el riesgo de contagio y la posibilidad de controlarlo; la letalidad y la presencia de curas o tratamientos; el ingreso; el número de personas que demandan y los costos de oportunidad de la empresa. Las empresas invertirán en mercados con demandas más inelásticas (enfermedades muy contagiosas sin posibilidad de controlar la transmisión y/o muy letales sin curas o tratamientos y/o donde los demandantes tienen elevados ingresos y/o son numerosos. No invertirá en mercados donde sus costos marginales son superiores a sus ingresos marginales, particularmente cuando sus costos incrementan permanentemente como consecuencia del aumento del costo de oportunidad generado por lo que dejaría de ganar en otros mercados. Para estos casos, las políticas de subsidio de la I+D no son efectivas, por lo tanto, éstas deben orientarse al fortalecimiento de las investigaciones, tanto básica como aplicada, realizadas por las instituciones públicas o sin fines de lucro.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

  9. Depositional history of sedimentary linear alkylbenzenes (LABs) in a large South American industrial coastal area (Santos Estuary, Southeastern Brazil)

    International Nuclear Information System (INIS)

    Martins, Cesar C.; Bicego, Marcia C.; Mahiques, Michel M.; Figueira, Rubens C.L.; Tessler, Moyses G.; Montone, Rosalinda C.

    2010-01-01

    This paper reports the reconstruction of the contamination history of a large South American industrial coastal area (Santos Estuary, Brazil) using linear alkylbenzenes (LABs). Three sediment cores were dated by 137 Cs. Concentrations in surficial layers were comparable to the midrange concentrations reported for coastal sediments worldwide. LAB concentrations increased towards the surface, indicating increased waste discharges into the estuary in recent decades. The highest concentration values occurred in the early 1970s, a time of intense industrial activity and marked population growth. The decreased LAB concentration, in the late 1970s was assumed to be the result of the world oil crisis. Treatment of industrial effluents, which began in 1984, was represented by decreased LAB levels. Microbial degradation of LABs may be more intense in the industrial area sediments. The results show that industrial and domestic waste discharges are a historical problem in the area. - The contamination history of a large South American industrial coastal area indicated by molecular indicator of sewage input.

  10. A Comparison of Customer Relationships between Large Chain Stores and Small Local Stores in the Fashion Industry

    OpenAIRE

    Krstevska, Biljana

    2017-01-01

    This research investigates customer relationships of two distinct store formats (small local stores and large chain stores) in the fashion industry. The aim is to find out if there are differences between the store formats regarding customer relationships. Relationship marketing theory was used to formulate hypotheses. Shoppers of small local stores and large chain stores in Würzburg, Germany, were surveyed to test the hypotheses. Results indicate that customer relationships significantly dif...

  11. Industrialization

    African Journals Online (AJOL)

    Lucy

    . African states as ... regarded as the most important ingredients that went to add value to land and labour in order for countries ... B. Sutcliffe Industry and Underdevelopment (Massachusetts Addison – Wesley Publishing Company. 1971), pp.

  12. Industrialization

    African Journals Online (AJOL)

    Lucy

    scholar, Walt W. Rostow presented and supported this line of thought in his analysis of ... A Brief Historical Background of Industrialization in Africa ... indicative) The western model allowed for the political economy to be shaped by market.

  13. Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease

    DEFF Research Database (Denmark)

    Jones, Roy; Wilkinson, David; Lopez, Oscar L

    2011-01-01

    community because of concerns that commercial, rather than scientific, goals are the primary purpose of such endeavours. Thus, there are few examples of sustained collaboration between leading academic clinical researchers and industry professionals in a large-scale data mining project. We present here...... a successful example of this type of collaboration in the field of dementia....

  14. Pharmaceutical Public-Private Partnerships

    DEFF Research Database (Denmark)

    Bagley, Constance; Tvarnø, Christina D.

    2014-01-01

    This article provides a game theory and law-and-management analysis of for- profit pharmaceutical public-private partnerships, a complex type of legal arrangement in the highly regulated pharmaceutical industry. A pharmaceutical public-private partnership (PPPP) agreement is a legally binding...... and a practical perspective on how properly crafted PPPP arrangements can promote innovation more efficiently than traditional self-optimizing contracts. In particular, a properly framed binding contract, coupled with respect for positive incentives, can move the parties away from an inefficient prisoners...... systems to build and share innovation. When coupled with appropriate attention to the difficult task of coordinating the actions of interdependent actors, a PPPP arrangement can enhance the likelihood of successful commercialization of pharmacological discoveries by flipping the par- ties’ incentives...

  15. Pharmaceutical marketing research and the prescribing physician.

    Science.gov (United States)

    Greene, Jeremy A

    2007-05-15

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

  16. Industry

    Energy Technology Data Exchange (ETDEWEB)

    Bernstein, Lenny; Roy, Joyashree; Delhotal, K. Casey; Harnisch, Jochen; Matsuhashi, Ryuji; Price, Lynn; Tanaka, Kanako; Worrell, Ernst; Yamba, Francis; Fengqi, Zhou; de la Rue du Can, Stephane; Gielen, Dolf; Joosen, Suzanne; Konar, Manaswita; Matysek, Anna; Miner, Reid; Okazaki, Teruo; Sanders, Johan; Sheinbaum Parado, Claudia

    2007-12-01

    This chapter addresses past, ongoing, and short (to 2010) and medium-term (to 2030) future actions that can be taken to mitigate GHG emissions from the manufacturing and process industries. Globally, and in most countries, CO{sub 2} accounts for more than 90% of CO{sub 2}-eq GHG emissions from the industrial sector (Price et al., 2006; US EPA, 2006b). These CO{sub 2} emissions arise from three sources: (1) the use of fossil fuels for energy, either directly by industry for heat and power generation or indirectly in the generation of purchased electricity and steam; (2) non-energy uses of fossil fuels in chemical processing and metal smelting; and (3) non-fossil fuel sources, for example cement and lime manufacture. Industrial processes also emit other GHGs, e.g.: (1) Nitrous oxide (N{sub 2}O) is emitted as a byproduct of adipic acid, nitric acid and caprolactam production; (2) HFC-23 is emitted as a byproduct of HCFC-22 production, a refrigerant, and also used in fluoroplastics manufacture; (3) Perfluorocarbons (PFCs) are emitted as byproducts of aluminium smelting and in semiconductor manufacture; (4) Sulphur hexafluoride (SF{sub 6}) is emitted in the manufacture, use and, decommissioning of gas insulated electrical switchgear, during the production of flat screen panels and semiconductors, from magnesium die casting and other industrial applications; (5) Methane (CH{sub 4}) is emitted as a byproduct of some chemical processes; and (6) CH{sub 4} and N{sub 2}O can be emitted by food industry waste streams. Many GHG emission mitigation options have been developed for the industrial sector. They fall into three categories: operating procedures, sector-wide technologies and process-specific technologies. A sampling of these options is discussed in Sections 7.2-7.4. The short- and medium-term potential for and cost of all classes of options are discussed in Section 7.5, barriers to the application of these options are addressed in Section 7.6 and the implication of

  17. Business Process Flow Diagrams in Tissue Bank Informatics System Design, and Identification and Communication of Best Practices: The Pharmaceutical Industry Experience.

    Science.gov (United States)

    McDonald, Sandra A; Velasco, Elizabeth; Ilasi, Nicholas T

    2010-12-01

    Pfizer, Inc.'s Tissue Bank, in conjunction with Pfizer's BioBank (biofluid repository), endeavored to create an overarching internal software package to cover all general functions of both research facilities, including sample receipt, reconciliation, processing, storage, and ordering. Business process flow diagrams were developed by the Tissue Bank and Informatics teams as a way of characterizing best practices both within the Bank and in its interactions with key internal and external stakeholders. Besides serving as a first step for the software development, such formalized process maps greatly assisted the identification and communication of best practices and the optimization of current procedures. The diagrams shared here could assist other biospecimen research repositories (both pharmaceutical and other settings) for comparative purposes or as a guide to successful informatics design. Therefore, it is recommended that biorepositories consider establishing formalized business process flow diagrams for their laboratories, to address these objectives of communication and strategy.

  18. The innovative use of a large-scale industry biomedical consortium to research the genetic basis of drug induced serious adverse events.

    Science.gov (United States)

    Holden, Arthur L

    2007-01-01

    The International Serious Adverse Event Consortium (SAEC) is a pharmaceutical industry and FDA led international (501 c3 non-profit) consortium, focused on identifying and validating DNA-variants useful in predicting the risk of drug induced, rare serious adverse events (SAEs). As such, it functions with the explicit purpose of enhancing the 'public good'. Its members are (i) organizations engaged principally in the business of discovering, developing and marketing pharmaceutical products, or (ii) a charitable, governmental, or other non-profit organization with an interest in researching the molecular basis of drug response.Drug-induced, rare SAEs present significant health issues for patients; and pose challenges for the safe use of approved drugs and the development of new drugs. Examples of drug-induced, rare SAEs include hepatotoxicity, QT prolongation, rhabdomyolosis, serious skin rashes (e.g. SJS), edema, acute renal failure, acute hypersensitivity, anemias/neutropenias, excessive weigh gain, retinopathy, vasculitis, among others. The rarity of such drug induced SAEs and the absence of effective government surveillance/research networks, makes it extremely difficult for any one company or research entity to accrue enough SAE cases and controls to conduct effective whole genome studies. Central to the notion of the SAEC is industry, government and health care providers can join forces to make use of a variety of sample and data resources in researching the genetic basis of these events.The purpose of the SAEC is threefold:•To carry out research directed toward the discovery of DNA-variants clinically useful in understanding and predicting the risk of drug induced serious adverse events and similar scientific research.•To ensure the widespread availability of the results of such research to the scientific research community and the public at large for no charge through publication and web-based methods; and•To educate the scientific research and medical

  19. Shaping a novel security approach in chemical industrial clusters to prevent large-scale domino events

    NARCIS (Netherlands)

    Reniers, Genserik L L; Dullaert, Wout; Soudan, Karel

    2009-01-01

    Two aspects are important when it comes to guaranteeing an effective and efficient security policy in a chemical industrial cluster. The first issue involves obtaining an acceptable level of collaboration between the different enterprises forming the cluster. The second topic is to ensure that an

  20. Mechanisms of public participation in siting and licensing of large industrial facilities

    International Nuclear Information System (INIS)

    Freymond, J.F.

    1993-01-01

    When we look at nuclear facilities in the perspective of the public participation we search for common points with other industrial plants of great risks. In most of countries nuclear facilities are treated in the perspective of public participation, this participation supposes a previous sufficient information; the public reaction is an inverse function of confidence in the authorities to manage that kind of problems

  1. Curbing variations in packaging process through Six Sigma way in a large-scale food-processing industry

    Science.gov (United States)

    Desai, Darshak A.; Kotadiya, Parth; Makwana, Nikheel; Patel, Sonalinkumar

    2015-03-01

    Indian industries need overall operational excellence for sustainable profitability and growth in the present age of global competitiveness. Among different quality and productivity improvement techniques, Six Sigma has emerged as one of the most effective breakthrough improvement strategies. Though Indian industries are exploring this improvement methodology to their advantage and reaping the benefits, not much has been presented and published regarding experience of Six Sigma in the food-processing industries. This paper is an effort to exemplify the application of Six Sigma quality improvement drive to one of the large-scale food-processing sectors in India. The paper discusses the phase wiz implementation of define, measure, analyze, improve, and control (DMAIC) on one of the chronic problems, variations in the weight of milk powder pouch. The paper wraps up with the improvements achieved and projected bottom-line gain to the unit by application of Six Sigma methodology.

  2. Information sources and utilization patterns of pharmaceutical ...

    African Journals Online (AJOL)

    The study investigated the adequacy of pharmaceutical scientists' information environment in feeding their occupational activities. Data was collected through observation and through questionnaire administration to all the twenty-seven scientists in two large pharmaceutical companies in Lagos, Nigeria. Findings revealed ...

  3. The Pharmaceutical Sector of Kazakhstan's Economy: Trends and Problems

    Science.gov (United States)

    Nurpeisov, Borankul G.; Nabiev, Erboz N.; Mukashev, Temirbay A.; Daribekov, Serik S.; Raimbekov, Bagdat Kh.; Asanova, Maral K.; Bazarbaeva, Leila M.

    2016-01-01

    This research is devoted to the investigation of the general trends in the development of the pharmaceutical industry in the current conditions of economical socialization. The determination of the economic specificity of the modern operation of the pharmaceutical industry is the purpose of the research. It was found that pharmacy is a profitable…

  4. Large Industrial Point Sources in Italy: a focus on mercury concentrations resulting from three seasonal ship-borne measurements

    Directory of Open Access Journals (Sweden)

    Bencardino M.

    2013-04-01

    Full Text Available In Italy there are 25 Large Industrial Point Sources whose mercury emissions in air exceed the established threshold of 10 kg year−1. Many of these mercury point sources, mostly distributed along the Italian coastal area, are located at sites qualified as National Interest Rehabilitation Sites because of documented contamination in qualitative and/or quantitative terms and of potential health impact. Atmospheric mercury emissions related to Italian Large Industrial Point Sources, with a value of 1.04 Mg·yr−1 for 2007, have a not negligible contribution, accounting, on their own, for more than 10% of the total mercury emissions resulting from all activity sectors at a national level. Among others, thermal power stations, pig iron and steel as well as basic inorganic chemical production, result to be the main contributing industrial activities. In order to assess how mercury species concentrations and distribution in the Marine Boundary Layer (MBL change with vicinity to large industrial sites, measurements of atmospheric mercury were performed during three oceanographic campaigns aboard the Research Vessel (R.V. Urania of the Italian CNR. Collection of GEM, GOM and PBM was conducted across the Adriatic sea, during autumn 2004 (27th of October to 12th of November and summer 2005 (17th to 29th of June, and across the Tyrrhenian sea during autumn 2007 (12th of September to 1st October. Analysis were carried out with reference to the period in which the R.V. Urania has stopped close to the main Italian industrial contaminated sites. Explorative statistical parameters of atmospheric mercury species were computed over each single stop-period and then compared with the overall cruise campaign measurements. Results are herein presented and discussed.

  5. Integrating systems Approaches into Pharmaceutical Sciences

    DEFF Research Database (Denmark)

    Westerhoff, H.V.; Mosekilde, Erik; Noe, C. R.

    2008-01-01

    During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and BioSim, the major European Network of Excellence on Systems Biology, held a challenging conference on the use of mathematical models in the drug development process. More precisely, the purpose...... of the conference was to promote the ‘Integration of Systems Approaches into Pharmaceutical Sciences’ in view of optimising the development of new effective drugs. And a challenge this is, considering both the high attrition rates in the pharmaceutical industry and the failure of finding definitive drug solutions...... for many of the diseases that plague mankind today. The conference was co-sponsored by the American College of Clinical Pharmacology, the European Center for Pharmaceutical Medicine, and the Swiss Society of Pharmaceutical Sciences and, besides representatives from the European Regulatory Agencies and FDA...

  6. How might the Trans-Pacific Partnership impact on the pharmaceutical sector in Vietnam?

    Science.gov (United States)

    Binh, Nguyen Hoa; Anh, Pham Ngoc Kieu; Phuong, Nguyen Minh

    2016-07-01

    Ratification of the Trans-Pacific Partnership (TPP) will attract a large number of foreign drug companies in the coming years to Vietnam. It is anticipated to bring investment to Vietnam's pharmaceutical industries, lead to increased infrastructure and enable the use of more sophisticated technologies for the discovery, development and manufacture of drugs. However, with respect to pharmaceutical companies, which are producing generic drugs primarily, the availability of biologic will be reduced. Thus, the consequence is, an increase in drug cost resulting in difficulties for patients wishing to procure these drugs. This will be particularly detrimental for developing countries, such as Vietnam and Malaysia.

  7. Characterization of cellulose biomass for use as an excipient in pharmaceutical field

    International Nuclear Information System (INIS)

    Garcia, Keth R.; Turella, Tais C.; Santos, Venina dos; Brandalise, Rosmary N.; Angeli, Valeria W.

    2015-01-01

    Every day the industry of paper and cellulose discards large amounts of waste. An alternative to reuse this kind of biomass is to transform part of it in cellulose nanocrystals and nanofibrils to be used as excipients in pharmaceutical field. Thus, cellulose fibrils were obtained in nanoscale using mill and fibrils' characterization study were performed by scanning electron microscopy, transmission electron microscopy, thermal analysis, differential scanning calorimetry, infrared Fourier transform and X-rays diffraction. Hence, the methodology used to obtain and characterize nanocellulose was effective and the fibers/fibrils lengths are in nanometer dimension with high potential to apply in the pharmaceutical field. (author)

  8. 3D rendering and interactive visualization technology in large industry CT

    International Nuclear Information System (INIS)

    Xiao Yongshun; Zhang Li; Chen Zhiqiang; Kang Kejun

    2001-01-01

    This paper introduces the applications of interactive 3D rendering technology in the large ICT. It summarizes and comments on the iso-surfaces rendering and the direct volume rendering methods used in ICT. The paper emphasizes on the technical analysis of the 3D rendering process of ICT volume data sets, and summarizes the difficulties of the inspection subsystem design in large ICT

  9. 3D rendering and interactive visualization technology in large industry CT

    International Nuclear Information System (INIS)

    Xiao Yongshun; Zhang Li; Chen Zhiqiang; Kang Kejun

    2002-01-01

    The author introduces the applications of interactive 3D rendering technology in the large ICT. It summarizes and comments on the iso-surfaces rendering and the direct volume rendering methods used in ICT. The author emphasizes on the technical analysis of the 3D rendering process of ICT volume data sets, and summarizes the difficulties of the inspection subsystem design in large ICT

  10. A Within-Industry Comparison of Employed Mothers' Experiences in Small and Large Workplaces.

    Science.gov (United States)

    MacDermid, Shelley M.; Williams, Margaret L.

    1997-01-01

    Focuses on links among mothers' (N=71) perceptions of their parenting practices, their parenting values, their children's behavior, and the work conditions they experience in small and large workplaces. Results found significant relationships between work conditions and parenting, and significant differences between small and large workplaces.…

  11. Development of large scale industrial complex and its pollution. Case study of Kashima area

    Energy Technology Data Exchange (ETDEWEB)

    Nagai, S

    1975-01-01

    The development of Kashima industrial complex which embraces three townships started in 1960 to promote both agricultural and industrial developments using the most advanced techniques available for environmental pollution control. The chronological development progress is described with reference to the capital investment, gross product, employment and labor supply, population, status of the use of agricultural land, annual revenue and expenditure of three townships, and township tax. The environmental pollution control policies and measures taken since 1964 are reviewed. The emphasis was placed on preliminary investigations by various means and emission standards were applied. However, many incidences of pollution damage occurred due to operational errors and accidental causes. The emission quantity of sulfur dioxide is to be reduced from 8212 N cu m/h in 1973 to 4625 N cu m/h in 1976.

  12. Control Optimization through Simulations of Large Scale Solar Plants for Industrial Heat Applications

    OpenAIRE

    Hassine, Ilyes Ben; Sehgelmeble., Mariela Cotrado; Söll, Robert; Pietruschka, Dirk

    2015-01-01

    The European FP7 Project InSun; which started in April 2012; aims to demonstrate the reliability and efficiency of three different collector technologies suitable for heat production employed in diverse industrial processes in different climatic regions. These collectors are installed and will be monitored in detail over a period of almost two years. One of the plants is installed at Fleischwaren Berger GmbH located in Sieghartskirchen, Austria, a company which produces meat and sausage p...

  13. Drivers Act behind Forming Strategic Alliances between Large and Small Players- The Case of Small Players in the Telecommunication Industry

    OpenAIRE

    Sultana, Kazi Afroza

    2016-01-01

    Background: Strategic alliances enable businesses to gain competitive advantage by providing access to the each other s resources which can be utilized to ensure the business profitability of the firms in the alliance. Telecommunication industry is dominated by large players, such as Mobile Network Operators. In contrary, comparatively small players, such as Mobile Virtual Network Operators, are struggling to sustain themselves in the business. Although a lot of literature is present on strat...

  14. Investigating the Impact uf E-Learning as an Alternative for Business Education in Pharmaceutical Industry in Romania by Roi Methodology

    Directory of Open Access Journals (Sweden)

    Petruţa Blaga

    2014-08-01

    Full Text Available The capability of organizations to accumulate and apply new knowledge is a key factor in order to achieve the new competitive standards. A continuous changing diversity, to which the need of adaptation to the changes of external environment is added, speeds up the rate of development and business education. The new information and communication technologies speed up the rate of change and increase the need of education that is subject to a higher information flow. The achievements of information technology, along with changes within society, determine the creation of new paradigms for business education and training. Under these circumstances, e-learning has become one of the main educational forms of human resources in business. This research aims to measure the impact of some initiatives within human resources on an organization, market leader within pharmaceutical field, namely measuring the efficiency of business education programs concerning human resources through e-learning. Under these circumstances, the carried-out research aims to put into practice the theoretical frame of ROI (Return on Investment methodology of evaluating the business education programs concerning human resources in five stages, suggested by J. J. Phillips. The research validates theoretical data of the surveyed model and it is based on the analysis of the data gathering process within the ROI Methodology. This work shows only aspects related to the measuring of the participants` reaction towards the e-learning business education program, respectively

  15. Pharmaceutical biotechnology: drug discovery and clinical applications

    National Research Council Canada - National Science Library

    Kayser, Oliver; Müller, Rainer H

    2004-01-01

    .... The biopharmaceutical industry has changed dramatically since the first recombinant ® protein (Humulin ) was approved for marketing in 1982. The range of resources required for the pharmaceutical industry has expanded from its traditional fields. Advances in the field of recombinant genetics allows scientists to routinely clone genes and create ge...

  16. LLNL medical and industrial laser isotope separation: large volume, low cost production through advanced laser technologies

    International Nuclear Information System (INIS)

    Comaskey, B.; Scheibner, K. F.; Shaw, M.; Wilder, J.

    1998-01-01

    The goal of this LDRD project was to demonstrate the technical and economical feasibility of applying laser isotope separation technology to the commercial enrichment (>lkg/y) of stable isotopes. A successful demonstration would well position the laboratory to make a credible case for the creation of an ongoing medical and industrial isotope production and development program at LLNL. Such a program would establish LLNL as a center for advanced medical isotope production, successfully leveraging previous LLNL Research and Development hardware, facilities, and knowledge

  17. Environmental pollution study around a large industrial area near Cairo, Egypt

    International Nuclear Information System (INIS)

    Abdel-Halim, A.S.

    2003-01-01

    Neutron activation analysis is one of the most extensively used methods for environmental studies due to its high sensitivity, precision, versatility and multielemental character. Cement factories at Helwan, south of Cairo, contribute substantially to environmental pollution. Determination of minor and trace-elements in dust particulates from the cement industrial areas has been performed to assess the air quality from an environmental and human health point of view. Soil-7 standard reference material from IAEA and SRM-1571 from NBS were used for quality assurance testing. The data obtained indicate there is an indication that the pollution could be hazardous to people living in and around the area surveyed. (author)

  18. Multifaceted role of clay minerals in pharmaceuticals

    OpenAIRE

    Khurana, Inderpreet Singh; Kaur, Satvinder; Kaur, Harpreet; Khurana, Rajneet Kaur

    2015-01-01

    The desirable physical and physiochemical properties of clay minerals have led them to play a substantial role in pharmaceutical formulations. Clay minerals like kaolin, smectite and palygorskite-sepiolite are among the world's most valuable industrial minerals and of considerable importance. The elemental features of clay minerals which caused them to be used in pharmaceutical formulations are high specific area, sorption capacity, favorable rheological properties, chemical inertness, swelli...

  19. Large-screen display industry: market and technology trends for direct view and projection displays

    Science.gov (United States)

    Castellano, Joseph A.; Mentley, David E.

    1996-03-01

    Large screen information displays are defined as dynamic electronic displays that can be viewed by more than one person and are at least 2-feet wide. These large area displays for public viewing provide convenience, entertainment, security, and efficiency to the viewers. There are numerous uses for large screen information displays including those in advertising, transportation, traffic control, conference room presentations, computer aided design, banking, and military command/control. A noticeable characteristic of the large screen display market is the interchangeability of display types. For any given application, the user can usually choose from at least three alternative technologies, and sometimes from many more. Some display types have features that make them suitable for specific applications due to temperature, brightness, power consumption, or other such characteristic. The overall worldwide unit consumption of large screen information displays of all types and for all applications (excluding consumer TV) will increase from 401,109 units in 1995 to 655,797 units in 2002. On a unit consumption basis, applications in business and education represent the largest share of unit consumption over this time period; in 1995, this application represented 69.7% of the total. The market (value of shipments) will grow from DOL3.1 billion in 1995 to DOL3.9 billion in 2002. The market will be dominated by front LCD projectors and LCD overhead projector plates.

  20. Patents for critical pharmaceuticals: the AZT case.

    Science.gov (United States)

    Ackiron, E

    1991-01-01

    Patents and other statutory types of market protections are used in the United States to promote scientific research and innovation. This incentive is especially important in research intensive fields such as the pharmaceutical industry. Unfortunately, these same protections often result in higher monopoly pricing once a successful product is brought to market. Usually this consequence is viewed as the necessary evil of an incentive system that encourages costly research and development by promising large rewards to the successful inventor. However, in the case of the AIDS drug Zidovudine (AZT), the high prices charged by the pharmaceutical company owning the drug have led to public outcry and a re-examination of government incentive systems. This Note traces the evolution of these incentive programs--the patent system, and, to a lesser extent, the orphan drug program--and details the conflicting interests involved in their development. It then demonstrates how the AZT problem brings the interest of providing inventors with incentives for risky innovative efforts into a sharp collision with the ultimate goal of such systems: ensuring that the public has access to the resulting products at a reasonable price. Finally, the Note describes how Congress and the courts have attempted to resolve these problems in the past, and how they might best try to solve the AZT problem in the near future.