WorldWideScience

Sample records for international pharmaceutical federation

  1. Use of the International Pharmaceutical Federation's Basel Statements to Assess and Advance Hospital Pharmacy Practice: A Scoping Review.

    Science.gov (United States)

    Penm, Jonathan; Chaar, Betty; Moles, Rebekah J

    2016-01-01

    The Basel statements of the International Pharmaceutical Federation, which provide the first global, unified vision for the hospital pharmacy profession, have recently been revised. Originally released in 2008, the Basel statements have since been made available in 21 languages, and thus have the potential for great impact around the world. To conduct a scoping review to examine the extent and nature of research activity related to the Basel statements. Google Scholar, PubMed, and International Pharmaceutical Abstracts were searched using the key term "Basel statements" for relevant research articles. From each included study, data were extracted on geographic location, study design, study outcomes, and use of the Basel statements. The search strategy generated 113 results. Further refinement resulted in 14 English-language articles that met the inclusion criteria. Four of these articles focused on adapting the Basel statements to European practice, an initiative of the European Association of Hospital Pharmacists that led to development of the European statements of Hospital Pharmacy. Six studies focused on monitoring hospital pharmacy practice in Uganda, the Pacific island countries, and the Western Pacific Region. These studies provide valuable baseline data to measure and track the development of hospital pharmacy practices in their respective countries and regions. The remaining 4 studies used qualitative methods to explore the barriers to and facilitators of implementation of the Basel statements in South Africa, China, and Australia. The Basel statements have led to multiple initiatives around the world, involving more than 70 countries. The European and Western Pacific regions have been the most active. Current initiatives should be continued to ensure identification and resolution of issues related to sustaining their use over time.

  2. Revision of the International Pharmaceutical Federation's Basel Statements on the future of hospital pharmacy: From Basel to Bangkok.

    Science.gov (United States)

    Vermeulen, Lee C; Moles, Rebekah J; Collins, Jack C; Gray, Andy; Sheikh, Abdul Latif; Surugue, Jacqueline; Moss, Robert J; Ivey, Marianne F; Stevenson, James G; Takeda, Yasuo; Ranjit, Eurek; Chaar, Betty; Penm, Jonathan

    2016-07-15

    The processes used to revise the 2008 Basel Statements on the future of hospital pharmacy are summarized, and the revised statements are presented. The process for revising the Basel Statements followed an approach similar to that used during their initial development. The Hospital Pharmacy Section (HPS) of the International Pharmaceutical Federation (FIP) revised the 2008 FIP Basel Statements in four phases, including a survey of hospital pharmacists worldwide, an internal review, online forums, and a face-to-face "World Café" workshop in Bangkok, Thailand. The global survey on the initial Basel Statements included input from 334 respondents from 62 countries. The majority of respondents agreed that most of the initial Basel Statements were acceptable as written and did not require revision. In total, 11 statements were judged by more than 10% of respondents as needing revision or deletion. The FIP HPS executive committee used the survey results to develop 69 initial revised draft statements. After an online discussion with the international hospital pharmacy community, including individuals from 28 countries representing all six World Health Organization regions, a final set of draft statements was prepared for the live discussion involving participants from 20 countries. The final 65 revised Basel Statements were voted on and accepted. Systematic revision of the FIP Basel Statements resulted in an updated reflection of aspirational goals for the future of hospital pharmacy practice. While this revision reflects the development of new goals for hospital pharmacy practice, the core principles of the Basel Statements remain an essential foundation for the discipline. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  3. International research networks in pharmaceuticals

    DEFF Research Database (Denmark)

    Cantner, Uwe; Rake, Bastian

    2014-01-01

    of scientific publications related to pharmaceutical research and applying social network analysis, we find that both the number of countries and their connectivity increase in almost all disease group specific networks. The cores of the networks consist of high income OECD countries and remain rather stable......Knowledge production and scientific research have become increasingly more collaborative and international, particularly in pharmaceuticals. We analyze this tendency in general and tie formation in international research networks on the country level in particular. Based on a unique dataset...... over time. Using network regression techniques to analyze the network dynamics our results indicate that accumulative advantages based on connectedness and multi-connectivity are positively related to changes in the countries' collaboration intensity whereas various indicators on similarity between...

  4. International pharmaceutical expenditure differentials: why?

    Science.gov (United States)

    Dickson, Michael

    2004-03-01

    The following questions facilitate further thought on the issue of reimportation: POLICY ISSUES: Who should pay for drug development? Do NCEs provide value for money invested? What is the most efficient means of developing new drugs? What is the proper balance between societal benefit and intellectual property protection? REGULATORY QUESTIONS: If reimportation or importation is permitted, how can the provenance of a product be protected? How is reimportation defined? Can a product be transported from the United States to Europe to Canada and then be sent back to the United States? Or, is reimportation a single-step process (e.g., United States to Canada and vice versa)? If reimportation is limited to Canada, can we expect that other countries would want to be included (or excluded) from our reimportation policy? Will state pharmacy practice acts be applicable to reimportation? Does reimportation alter the balance between state and federal regulations? If legal action occurs because of alleged harm from a reimported product, who is liable? MARKET ISSUES: Will U.S. prices rise in protected markets to compensate for losses due to reimports? Will Canadians be allowed to import prescription drugs from the United States?

  5. 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.

  6. Features of Internal Audit in Pharmaceutical Industry

    OpenAIRE

    Tsvetanova, Yulia

    2014-01-01

    The review highlights the main features of internal audit by focus on distribution of medicinal products. Recent data suggest internal audit as an antidote to effects of economic recession. The present review reveals internal audit as a tool for competitiveness through implementation of good practices. The purpose of the review is to describe the advantages of internal audit in new institutional frame. The object of analysis is the distribution practice, and more concrete, the wholesale di...

  7. Impacts of international sanctions on Iranian pharmaceutical market.

    Science.gov (United States)

    Cheraghali, Abdol Majid

    2013-07-31

    Iran in recent decade faced several regional and international sanctions in foreign trade, financial and banking services. Iran national pharmaceutical industry has always played a major role in providing medicines to the Iranian patients. However, following the sanctions it has faced profound difficulties for importing of both finished products and pharmaceutical raw materials. Although medicines are exempted from sanctions, due to restriction on money transaction and proper insurance Iranian pharmaceutical companies have to pay cash in advance for imports of medicines and raw materials or to secure offshore funds at very high risks. Current situation in Iran pharmaceutical market confirms that the sanctions against Iran are affecting ordinary citizens and national health sector which resulted to reduction of availability of lifesaving medicines in the local market and has caused increasing pain and suffering for Iranian patients.

  8. 78 FR 26375 - Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship...

    Science.gov (United States)

    2013-05-06

    ...] Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship... Society of Pharmaceutical Engineering (ISPE), is announcing a conference entitled ``Redefining the `C' in CGMP: Creating, Implementing and Sustaining a Culture of Quality'' Pharmaceutical Quality System (ICH...

  9. Network on veterinary medicines initiated by the European Federation For Pharmaceutical Sciences.

    Science.gov (United States)

    Mochel, J P; Tyden, E; Hellmann, K; Vendrig, J C; Şenel, S; Dencker, L; Cristina, R T; Linden, H; Schmerold, I

    2018-06-01

    The European Federation for Pharmaceutical Sciences (EUFEPS) was founded 25 years ago by more than 20 national pharmaceutical societies and faculty members. As a pan-European organization, it brings together pharmaceutical societies as well as academic, industrial and regulatory scientists engaged in drug research and development, drug regulation and education of professionals working in these fields. EUFEPS represents pharmaceutical sciences in Europe and is recognized as such by both the European Commission and the European Medicines Agency. EUFEPS cooperates with the European Federation of Pharmaceutical Industries and other European organizations and maintains global connections with agencies such as the US Food and Drug Administration and the American Association of Pharmaceutical Scientists. EUFEPS has established specified networks forming the basis of its activities. The creation of a Network on Veterinary Medicines is prompted by the manifold problems resulting from the use of veterinary drugs and its inherent interconnections with human medicine, environmental and public health. A long-term goal of this initiative was to expand the spectrum of available therapeutics for use in animals, including the development of innovative delivery systems. © 2017 John Wiley & Sons Ltd.

  10. [Operation Pangea - standing together in combat against international pharmaceutical crime].

    Science.gov (United States)

    Smolka, Kirstin; Gronwald, Klaus

    2017-11-01

    Crime on the internet has grown accordingly to the increased use of the internet in everyday life. This includes illegal trading of pharmaceuticals via the internet. Trading in pharmaceuticals as "special commodities" underlies certain legal regulations in Germany, as in most other countries worldwide.Mail order trade (colloquially also known as internet trade) in pharmaceuticals requires approval of the competent regulatory authority. However, numerous illegal internet vendors of medicines present their websites to customers, purporting to be legal pharmacies and trading good and genuine medicines.It is not always easy for customers or patients to distinguish between legal websites, i. e. pharmacies operating with the approval of the authorities, and illegal, criminal websites. Patients accept dangerous risks when they order medicines on such illegal websites. Consumption of falsified or unlicensed pharmaceuticals of unknown origin often exposes patients' health to serious risks and dangers.Operation PANGEA is now in its tenth year of fighting illegal internet trade in pharmaceuticals at an internationally coordinated level. The results of Operation PANGEA are published in national and international media. Thus the public should be alert to the risks of buying medicines from one of the numerous illegal vendors on the internet.The competence for combatting illegal sales of medicines lies with customs and police agencies amongst others. These enforcement agencies regularly participate in the annual PANGEA Operations. The following article describes the origin and background of this operation, and outlines both the work of customs and police in this context, as well as the results of the latest PANGEA Operation.

  11. NASA and the Federal Management Intern Program.

    Science.gov (United States)

    Pound, Jack K.; Slack, Vivian M.

    A review of NASA Federal Management Intern (MI) programs indicates potential for identification, attraction, and early development of successful administrative management employees, but suggests that successful development of managers is a function of the long-term care with which an agency pursues MI programs. A recent study of separations in…

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

    Science.gov (United States)

    2009-04-08

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

  13. 76 FR 57746 - Conference on the International Conference on Harmonisation Q10 Pharmaceutical Quality System: A...

    Science.gov (United States)

    2011-09-16

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

  14. International price comparisons for pharmaceuticals. Measurement and policy issues.

    Science.gov (United States)

    Danzon, P M; Kim, J D

    1998-01-01

    Cross-national price comparisons for pharmaceuticals are commonly used for two purposes. Comparisons based on a sample of products are used to draw conclusions about differences in average price levels. Cross-national comparisons applied to individual products are also used by governments to set domestic prices. This paper examines the major methodological issues raised by international price comparisons, focusing on measurement of differences in average price levels and the validity of policy conclusions drawn from such price comparison studies. It argues that valid measures of average price levels can only be obtained from comparisons based on a comprehensive or representative sample of products, appropriately weighted, following standard index number methods. Comparisons of individual product prices should take into account the manufacturer's entire product portfolio over time rather than focus narrowly on a single product at a point in time. Because of the great variation across countries in both the range of drug compounds available and the dosage forms, strengths and pack sizes for each compound, obtaining a broadly comprehensive or representative sample is problematical. If products are required to match on all dimensions, including molecule, manufacturer, strength and pack, as is common in most international price comparisons, then only a very small and unrepresentative sample of the drugs available in each country can be included in the analysis. A trade-off between the desire to compare only identical products and the need to compare a truly representative sample of a country's pharmaceutical market is therefore necessary. A valid comparison of average drug prices should include generics and over-the-counter products that are good substitutes for branded prescription drugs, with all forms, strengths and packs. To achieve this broad representation, however, the requirements of same manufacturer, same brand, dosage form, strength and pack size must be

  15. 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.

  16. Unhealthy marketing of pharmaceutical products: An international public health concern.

    Science.gov (United States)

    Mulinari, Shai

    2016-05-01

    I consider the current state of pharmaceutical marketing vis-à-vis ethical and legal standards and advocate measures to improve it. There is abundant evidence of unethical or illicit marketing. It fuels growing concerns about undue corporate influence over pharmaceutical research, education, and consumption. The most extensive evidence of industry transgressions comes from the United States (US), where whistle-blowers are encouraged by financial rewards to help uncover illicit marketing and fraud. Outside the US increasing evidence of transgressions exists. Recently I have observed a range of new measures to align pharmaceutical marketing practices with ethical and legal standards. In the interest of public health, I highlight the need for additional and more profound reforms to ensure that information about medicines supports quality and resource-efficient care.

  17. Recovering fraudulent claims for Australian federal expenditure on pharmaceuticals and medical devices.

    Science.gov (United States)

    Faunce, Thomas; Urbas, Gregor; Skillen, Lesley; Smith, Marc

    2010-12-01

    The Australian Federal Government expends increasingly large amounts of money on pharmaceuticals and medical devices. It is likely, given government experience in other jurisdictions, that a significant proportion of this expenditure is paid as a result of fraudulent claims presented by corporations. In the United States, legislation such as the False Claims Act 1986 (US), the Fraud Enforcement and Recovery Act 2009 (US), the Stark (Physician Self-Referral) Statute 1995 (US), the Anti-Kickback Statute 1972 (US), the Food, Drug and Cosmetic Act 1938 (US), the Social Security Act 1965 (US), and the Patient Protection and Affordable Care Act 2010 (US) has created systematic processes allowing the United States Federal Government to recover billions of dollars in fraudulently made claims in the health and procurement areas. The crucial component involves the creation of financial incentives for information about fraud to be revealed from within the corporate sector to the appropriate state officials. This article explores the opportunities for creating a similar system in Australia in the health care setting.

  18. On international cost-sharing of pharmaceutical R&D.

    Science.gov (United States)

    Barros, Pedro Pita; Martinez-Giralt, Xavier

    2008-12-01

    Ramsey pricing has been proposed in the pharmaceutical industry as a principle to price discriminate among markets while allowing to recover the (fixed) R&D cost. However, such analyses neglect the presence of insurance or the fund raising costs for most of drug reimbursement. By incorporating these new elements, we aim at providing some building blocks towards an economic theory incorporating Ramsey pricing and insurance coverage. We show how coinsurance affects the optimal prices to pay for the R&D investment. We also show that under certain conditions, there is no strategic incentive by governments to set coinsurance rates in order to shift the financial burden of R&D. This will have important implications to the application of Ramsey pricing principles to pharmaceutical products across countries.

  19. 76 FR 78258 - Valeant Pharmaceuticals International, Inc.; Analysis of Agreement Containing Consent Order to...

    Science.gov (United States)

    2011-12-16

    ....htm . Analysis of Agreement Containing Consent Order to Aid Public Comment I. Introduction The Federal... merger in this market. Specifically, the Consent Agreement requires that Valeant return the marketing... highly concentrated. Pursuant to a co-marketing agreement between Valeant and Spear Pharmaceuticals...

  20. Internal Structure Quality Control of Solid Pharmaceuticals. A Comparative Study

    Directory of Open Access Journals (Sweden)

    Imre Silvia

    2016-03-01

    Full Text Available Objective: The aim of the study was a comparative investigation by spectral and thermal analysis in order to asses a number of characteristics of different varieties ofrawmaterials of ursodeoxycholic acid and ibuprofen. The different dissolution behavior of two ursodeoxycholic acid pharmaceutical product by crystallinity pattern was investigated. Methods: Raw materials of ursodeoxycholic acid and ibuprofen were used. IR spectroscopy, differential scanning calorimetry and X-Ray Diffraction Analysis were applied. Results: The results show no crystallinitydifferences for different batches of the tested drugs. No solid solid transition was proved during sample preparation for transmission IR analysis. Conclusions: A combination of two more affordabletests by IR spectrometry and differential scanning calorimetry lead to the same results as X-Ray diffraction analysis for crystallinity similarity assessment of the studied substances. The dissolution differences of test drugs were not related to the polymorphism of the raw materials.

  1. Temperance internationalism: Guy Hayler and the World Prohibition Federation.

    Science.gov (United States)

    Fahey, David M

    2006-01-01

    The World Prohibition Federation, organized in 1909, and the International Record, published from 1917 to 1968, sought to internationalize the temperance movement by collecting and disseminating anti-drink news from around the globe. The Federation was based in London, and most of its activities were English-speakers. A British reformer named Guy Hayler served as its honorary president for thirty years and edited the "International Record" until his death in 1943. The Federation emphasized that prohibitionists comprised a moral community, united regardless of race, religion, nationality, or politics. Poorly funded, the Federation had difficulty competing with the World League against Alcoholism after the Anti-Saloon League of America organized this rival propaganda society in 1919.

  2. Development of Taiwan's strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations.

    Science.gov (United States)

    Guo, Jiun-Wen; Lee, Yu-Hsuan; Huang, Hsiau-Wen; Tzou, Mei-Chyun; Wang, Ying-Jan; Tsai, Jui-Chen

    2014-01-01

    Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan's regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan.

  3. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

    Directory of Open Access Journals (Sweden)

    Nguyen Diane

    2013-01-01

    Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by

  4. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

    Science.gov (United States)

    Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

    2013-01-22

    The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5

  5. International Geoscience Workforce Trends: More Challenges for Federal Agencies

    Science.gov (United States)

    Groat, C. G.

    2005-12-01

    Concern about the decreasing number of students entering undergraduate geoscience programs has been chronic and, at times, acute over the past three decades. Despite dwindling populations of undergraduate majors, graduate programs have remained relatively robust, bolstered by international students. With Increasing competition for graduate students by universities in Europe, Japan, Australia, and some developing countries, and with procedural challenges faced by international students seeking entry into the United States and its universities, this supply source is threatened. For corporations operating on a global scale, the opportunity to employ students from and trained in the regions in which they operate is generally a plus. For U.S. universities that have traditionally supplied this workforce, the changing situation poses challenges, but also opportunities for creative international partnerships. Federal government science agencies face more challenges than opportunities in meeting workforce needs under both present and changing education conditions. Restrictions on hiring non-U.S. citizens into the permanent workforce have been a long-standing issue for federal agencies. Exceptions are granted only where they can document the absence of eligible U.S.-citizen candidates. The U.S. Geological Survey has been successful in doing this in its Mendenhall Postdoctoral Research Fellowship Program, but there has been no solution to the broader limitation. Under current and forecast workforce recruitment conditions, creativity, such as that evidenced by the Mendenhall program,will be necessary if federal agencies are to draw from the increasingly international geoscience talent pool. With fewer U.S. citizens in U.S. geoscience graduate programs and a growing number of advanced-degreed scientists coming from universities outside the U.S., the need for changes in federal hiring policies is heightened. The near-term liklihood of this is low and combined with the decline in

  6. Federalism and decentralization: impact on international and Brazilian health policies.

    Science.gov (United States)

    Leite, Valéria Rodrigues; de Vasconcelos, Cipriano Maia; Lima, Kenio Costa

    2011-01-01

    This article discusses the implications of decentralization in the light of international and Brazilian federalism, and its effects on public health policy. In a comparative analysis among countries, the authors find there is no single model; rather, each country has a unique structure of institutions and norms that have important implications for the operation of its health system. Brazil shares some similarities with other countries that have adopted a decentralized system and is assuming features ever closer to U.S. federalism, with a complex web of relationships. The degree of inequality among Brazilian municipalities and states, along with the budgetary imbalances caused by the minimal levels of resource utilization, undermines Brazil's constitutional principles and, consequently, its federalism. To ensure the constitutional mandate in Brazil, it is essential, as in other countries, to create a stable source of funds and increase the volume and efficiency of spending. Also important are investing in the training of managers, improving information systems, strengthening the principles of autonomy and interdependence, and defining patterns of cooperation within the federation.

  7. NanoXCT: a novel technique to probe the internal architecture of pharmaceutical particles.

    Science.gov (United States)

    Wong, Jennifer; D'Sa, Dexter; Foley, Matthew; Chan, John Gar Yan; Chan, Hak-Kim

    2014-11-01

    To demonstrate the novel application of nano X-ray computed tomography (NanoXCT) for visualizing and quantifying the internal structures of pharmaceutical particles. An Xradia NanoXCT-100, which produces ultra high-resolution and non-destructive imaging that can be reconstructed in three-dimensions (3D), was used to characterize several pharmaceutical particles. Depending on the particle size of the sample, NanoXCT was operated in Zernike Phase Contrast (ZPC) mode using either: 1) large field of view (LFOV), which has a two-dimensional (2D) spatial resolution of 172 nm; or 2) high resolution (HRES) that has a resolution of 43.7 nm. Various pharmaceutical particles with different physicochemical properties were investigated, including raw (2-hydroxypropyl)-beta-cyclodextrin (HβCD), poly (lactic-co-glycolic) acid (PLGA) microparticles, and spray-dried particles that included smooth and nanomatrix bovine serum albumin (BSA), lipid-based carriers, and mannitol. Both raw HβCD and PLGA microparticles had a network of voids, whereas spray-dried smooth BSA and mannitol generally had a single void. Lipid-based carriers and nanomatrix BSA particles resulted in low quality images due to high noise-to-signal ratio. The quantitative capabilities of NanoXCT were also demonstrated where spray-dried mannitol was found to have an average void volume of 0.117 ± 0.247 μm(3) and average void-to-material percentage of 3.5%. The single PLGA particle had values of 1993 μm(3) and 59.3%, respectively. This study reports the first series of non-destructive 3D visualizations of inhalable pharmaceutical particles. Overall, NanoXCT presents a powerful tool to dissect and observe the interior of pharmaceutical particles, including those of a respirable size.

  8. 15th Conference of the International Federation of Classification Societies

    CERN Document Server

    Montanari, Angela; Vichi, Maurizio

    2017-01-01

    This edited volume on the latest advances in data science covers a wide range of topics in the context of data analysis and classification. In particular, it includes contributions on classification methods for high-dimensional data, clustering methods, multivariate statistical methods, and various applications. The book gathers a selection of peer-reviewed contributions presented at the Fifteenth Conference of the International Federation of Classification Societies (IFCS2015), which was hosted by the Alma Mater Studiorum, University of Bologna, from July 5 to 8, 2015.

  9. GC-MS quantitative analysis of black market pharmaceutical products containing anabolic androgenic steroids seized by the Brazilian Federal Police.

    Science.gov (United States)

    Neves, Diana Brito da Justa; Caldas, Eloisa Dutra

    2017-06-01

    The use of counterfeit or substandard medicines can have an important health impact, resulting in therapeutic failure, be toxic or even cause death. Anabolic steroids are a frequent target for counterfeiters worldwide, being the second most frequent counterfeited class in Brazil. The aims of this work were to optimize and validate a GC-MS method for the quantitative determination of anabolic steroids in tablet, aqueous suspension and oil solution forms, and to analyze pharmaceutical products sent to Brazilian Federal Police (BFP) for forensic analysis. Sample preparation included extraction with methanol in ultrasonic bath followed by centrifugation. The method was successfully validated and 345 samples of pharmaceutical products were analyzed (328 medicines and 17 dietary supplements). About 42% of the medicines were counterfeits, 28.7% of tablets, 12.0% of suspensions and 65.2% of oil solutions; 11% were considered substandards. Five dietary supplements contained undeclared anabolic steroids, including two containing methandrostenolone at 5.4 and 5.8mg/capsule, equivalent to levels found in medicines. The proposed method is suitable for implementation in routine analysis for identification of counterfeits and substandard products. The analytical results show the need to raise awareness of consumers over the risks from the consumption of anabolic steroids from the clandestine market and for more incisive actions from government agencies aiming at decreasing the availability of these products. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. The Thalassemia International Federation: a global public health paradigm

    Directory of Open Access Journals (Sweden)

    Elpidoforos S. Soteriades

    2014-09-01

    Full Text Available Many international organizations are struggling today to coordinate limited economic and human resources in support of governments’ efforts to advance public health around the world. The United Nations and the World Health Organization, along with others play a pivotal role in this global effort. Furthermore, during the past few decades an increasingly higher percentage of global efforts on public health are carried out by specific health initiatives, international projects and non-governmental patient-oriented organizations. The Thalassemia International Federation (TIF is one such organization focusing on the control of thalassemia around the world. The current paper aims at presenting a comprehensive overview of the mission, goals, objectives and activities of this organization. Our ultimate goal is to highlight TIF’s public health paradigm and diffuse its success at an international levels for others to follow. TIF is devoted to disseminating information, knowledge, experience and best practices around the world to empower patients with thalassemia and their relatives, support health professionals providing care to such patients and promote national and international policies, which secure equal access to quality care for all patients with thalassemia.

  11. 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.

  12. International Citizenship and the International Federation of University Women before 1939

    Science.gov (United States)

    Goodman, Joyce

    2011-01-01

    This article explores discursive languages through which leading women in the International Federation of University Women (IFUW) articulated their understandings of world citizenship and looks at what Caroline Spurgeon, the first President of the IFUW, called the "organised training of women to be citizens of the world." The central section…

  13. The international pharmaceutical market as a source of low-cost prescription drugs for U.S. patients.

    Science.gov (United States)

    Kesselheim, Aaron S; Choudhry, Niteesh K

    2008-04-15

    In response to increasing prescription drug costs, more U.S. patients and policymakers are importing less-expensive pharmaceutical products from other countries. Large-scale prescription drug importation is currently illegal, but the U.S. Food and Drug Administration permits individuals to bring in 90-day supplies of drugs for personal use. As patient use of foreign-bought drugs has increased, federal legislators have continued to debate the full legalization of importation. Three factors help guide whether U.S. patients and policymakers can rely on other countries as sources of imported prescription drugs: whether the safety of the product can be ensured, how the import price compares with domestic prices, and how importation might affect the exporting country's pharmaceutical market. In wealthier countries with active regulatory systems, drug safety can be adequately ensured, and brand-name products are usually less expensive than in the United States (although generic drugs may be more expensive). However, implementing large-scale importation can negatively impact the originating country's market and can diminish the long-term cost savings for U.S. consumers. In low- and middle-income countries, prices may be reduced for both brand-name and generic drugs, but the prevalence of unauthorized products on the market makes ensuring drug safety more difficult. It may be reasonable for individual U.S. consumers to purchase essential medicines from certain international markets, but the most effective way to decrease drug costs overall is the appropriate use of domestic generic drugs, which are available for almost every major therapeutic class.

  14. 5th Conference of the International Federation of Classification Societies

    CERN Document Server

    Yajima, Keiji; Bock, Hans-Hermann; Ohsumi, Noboru; Tanaka, Yutaka; Baba, Yasumasa

    1998-01-01

    This volume, Data Science, Classification, and Related Methods, contains a selection of papers presented at the Fifth Conference of the International Federation of Oassification Societies (IFCS-96), which was held in Kobe, Japan, from March 27 to 30,1996. The volume covers a wide range of topics and perspectives in the growing field of data science, including theoretical and methodological advances in domains relating to data gathering, classification and clustering, exploratory and multivariate data analysis, and knowledge discovery and seeking. It gives a broad view of the state of the art and is intended for those in the scientific community who either develop new data analysis methods or gather data and use search tools for analyzing and interpreting large and complex data sets. Presenting a wide field of applications, this book is of interest not only to data analysts, mathematicians, and statisticians but also to scientists from many areas and disciplines concerned with complex data: medicine, biology, ...

  15. A Co-evolutionary perspective on the Drivers of International Sourcing of Pharmaceutical R&D to India

    DEFF Research Database (Denmark)

    Haakonsson, Stine Jessen; Ørberg Jensen, Peter D.; M. Mudambi, Susan

    2013-01-01

    -evolutionary theory perspective embracing both firm-internal and firm-environmental factors for location attractiveness, along with institutional and industry changes. The framework integrates constructs from past research in economic geography, international business, and R&D internationalization. The Indian case......The attractiveness of the Indian pharmaceutical industry as a destination for R&D sourcing by multinational corporations (MNCs) has evolved over the past decades. This evolution has coincided with changes in MNC strategies regarding sourcing location and governance modes. We propose a co...... illustrates how host-country institutional evolution, notably regarding intellectual property rights and education, plays a significant role for international sourcing of pharmaceutical R&D....

  16. Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations

    Directory of Open Access Journals (Sweden)

    Guo JW

    2014-10-01

    Full Text Available Jiun-Wen Guo,1 Yu-Hsuan Lee,2 Hsiau-Wen Huang,3 Mei-Chyun Tzou,3 Ying-Jan Wang,2 Jui-Chen Tsai1,4 1Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Chung Kung University, Tainan, Taiwan; 2Department of Environmental and Occupational Health, College of Medicine, National Cheng Kung University, Tainan, Taiwan; 3Food and Drug Administration, Ministry of Health and Welfare, Taiwan; 4Center for Pharmaceutical Regulatory Science, National Cheng Kung University, Tainan, Taiwan Abstract: Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan’s regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may

  17. Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals.

    Science.gov (United States)

    Nasr, Moheb M; Krumme, Markus; Matsuda, Yoshihiro; Trout, Bernhardt L; Badman, Clive; Mascia, Salvatore; Cooney, Charles L; Jensen, Keith D; Florence, Alastair; Johnston, Craig; Konstantinov, Konstantin; Lee, Sau L

    2017-11-01

    Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is based on the 2nd International Symposium on the Continuous Manufacturing of Pharmaceuticals, describes not only the advances that have taken place since the first International Symposium on Continuous Manufacturing of Pharmaceuticals in 2014, but the regulatory landscape that exists today. Key regulatory concepts including quality risk management, batch definition, control strategy, process monitoring and control, real-time release testing, data processing and management, and process validation/verification are outlined. Support from regulatory agencies, particularly in the form of the harmonization of regulatory expectations, will be crucial to the successful implementation of continuous manufacturing. Collaborative efforts, among academia, industry, and regulatory agencies, are the optimal solution for ensuring a solid future for this promising manufacturing technology. Copyright © 2017 American Pharmacists Association®. All rights reserved.

  18. 78 FR 68447 - Exposure Draft-Standards for Internal Control in the Federal Government

    Science.gov (United States)

    2013-11-14

    ... GOVERNMENT ACCOUNTABILITY OFFICE Exposure Draft--Standards for Internal Control in the Federal... revisions to the Standards for Internal Control in the Federal Government, known as the ``Green Book,'' to... proposed changes contained in the 2013 Exposure Draft update to the Standards for Internal Control in the...

  19. 78 FR 22263 - Advisory Council on the Standards for Internal Control in the Federal Government; Meeting

    Science.gov (United States)

    2013-04-15

    ... GOVERNMENT ACCOUNTABILITY OFFICE Advisory Council on the Standards for Internal Control in the... Standards for Internal Control in the Federal Government; Notice of Meeting. SUMMARY: The US Government Accountability Office (GAO) is initiating efforts to revise the Standards for Internal Control in the Federal...

  20. Pengaruh Pemberian Insentif terhadap Semangat Kerja Karyawan Departemen Marketing pada PT. Federal International Finance Pekanbaru

    OpenAIRE

    Heriyanto, Meyzi; Atmaja, Surya

    2014-01-01

    This research was conducted in PT. Federal International Finance Pekanbaru. The setting of this problem is the influence the granting of incentives to employeer morale the Department of Marketing at PT. Federal International Finance Pekanbaru. The purpose of this research is to know the granting of incentives, morale, and know how the granting of incentives to employeer morale the Department of Marketing at PT. Federal International Finance Pekanbaru.The author uses descriptive quantitative m...

  1. International Field School on Permafrost: Yenisei, Russian Federation - 2013

    Science.gov (United States)

    Nyland, K. E.; Streletskiy, D. A.; Grebenets, V. I.

    2013-12-01

    The International Field School on Permafrost was established in Russia as part of International Polar Year activities. The first course was offered in 2007 in Northwestern Siberia and attracted students from Russia, Germany, and the United States. Over the past seven years undergraduate and graduate students representing eight different countries in North America, Europe, and Asia have participated in the field school. This annual summer field course visits different regions of the Russian Arctic each year, but the three course foci remain consistent, which are to make in depth examinations of, 1) natural permafrost characteristics and conditions, 2) field techniques and applications, and 3) engineering practices and construction on permafrost. During these field courses students participate in excursions to local museums and exhibitions, meet with representatives from local administrations, mining and construction industries, and learn field techniques for complex permafrost investigations, including landscape and soil descriptions, temperature monitoring, active-layer measurements, cryostratigraphy, and more. During these courses students attend an evening lecture series by their professors and also give presentations on various regionally oriented topics of interest, such as the local geology, climate, or historical development of the region. This presentation will relate this summer's (July 2013) field course which took place in the Yenisei River region of central Siberia. The course took place along a bioclimatic transect from south to north along the Yenisei River and featured extended stays in the cities of Igarka and Noril'sk. This year's students (undergraduate, masters, and one PhD student) represented universities in the United States, Canada, and the Russian Federation. The organization of this course was accomplished through the cooperation of The George Washington University's Department of Geography and the Lomonosov Moscow State University

  2. 78 FR 36723 - Federal Management Regulation (FMR); Restrictions on International Transportation of Freight and...

    Science.gov (United States)

    2013-06-19

    ..., Sequence 1] RIN 3090-AJ34 Federal Management Regulation (FMR); Restrictions on International Transportation... Administration (GSA). ACTION: Proposed rule. SUMMARY: GSA is proposing to amend the Federal Management Regulation... Federal Management Regulation (FMR) to state clearly that this part applies to all agencies and wholly...

  3. Russian Federal Nuclear Center VNIIEF - possibilities of international cooperation

    International Nuclear Information System (INIS)

    Shaburov, V.M.; Mozharov, R.V.

    2000-01-01

    The Russian Federation Nuclear Center - the All-Russian Experimental Physics Research Institute (RFNC-AREPRI; VNIIEF) is a major scientific-technical center of Russia capable of solving the most difficult problems in the interests of defense, science and the national economy. There was a time when the RFNC-AREPRI played a decisive role in liquidating the U.S. monopoly on nuclear weapons and ensuring half a century of world civilization without global political and military conflicts. Today, RFNC-AREPRI specialists are entrusted with the mission of maintaining and perfecting Russia's nuclear shield that ensures its security and independence. As well as defense-oriented projects, the Institute is busy developing and implementing a number of projects in the most diverse fields of science and technology. At present, the Institute possesses an experimental and testing base that includes: a gas dynamic complex for testing manufactured products and explosives, irradiation facilities, nuclear reactors, laser systems, complexes for mechanical, temperature and climatic testing of specific manufactured products and instruments, and an aero-ballistic testing complex. The Institute's material base, with its mathematical support, is one of the most powerful in Russia. The RFNC-AREPRI employs about 20,000 workers, including 9,500 scientists and engineers. Today, the RFNC-AREPRI is engaged in activities in the following principal directions: - properties of material under extreme pressure and temperature; - gas dynamics; - nuclear physics; - radiation physics; - laser physics and equipment; - super-powerful magnetic fields; - high-temperature plasma physics; - development of physical models of complex physical processes and the creation of mathematical methodologies and software based on these models; - energy; - medicine; - ecology; - progressive technologies for various sectors of the economy. International cooperation of the RFNC-AREPRI is reviewed. (authors)

  4. 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.

  5. Pharmaceutical wastewater treatment by internal micro-electrolysis--coagulation, biological treatment and activated carbon adsorption.

    Science.gov (United States)

    Wang, Kangle; Liu, Suiqing; Zhang, Qiang; He, Yiliang

    2009-12-01

    Treatment of pharmaceutical wastewater by the combined process of internal micro-electrolysis and coagulation, biological treatment and activated carbon adsorption was studied. Internal micro-electrolysis and coagulation served as the pretreatment for the wastewater before biological treatment to reduce the contaminants' toxicity to microbes and improve the biodegradability of wastewater to guarantee the smooth operation of the biological process. Biological treatment was the main body of the whole process which took an unparalleled role in removing COD (chemical oxygen demand). Activated carbon adsorption was adopted as the post-treatment process to further remove the remaining non-biodegradable particles. Results showed that the removal rates of COD and S2- (sulphide ion) by pretreatment were 66.9% and 98.9%, respectively, and the biodegradability, as measured by the ratio of biodegradable COD to initial COD, of the wastewater was greatly improved from 0.16 +/- 0.02 to 0.41 +/- 0.02. The overall removal rate of COD in the wastewater achieved by this combined treatment process was up to 96%, and the effluent COD met the Chinese tertiary discharge standard (GB 8978-1996).

  6. Impact of Brand Orientation, Internal Marketing and Job Satisfaction on the Internal Brand Equity: The Case of Iranian’s Food and Pharmaceutical Companies

    Directory of Open Access Journals (Sweden)

    Shahriar Azizi

    2012-01-01

    Full Text Available Internal branding has been emerging recently as an important issue in marketing field. This study provides insights into how job satisfaction, internal marketing and brand orientation shape employees internal brand equity. Empirical data were collected by a questionnaire distributed to food and pharmaceutical firms. The empirical results indicated that while brand orientation and internal marketing were found to have impact on internal brand equity, job satisfaction has no effect on internal brand equity. Additionally, it was observed that job satisfaction and internal marketing has direct and positive impact on brand orientation and therefore indirect and positive impact on internal brand equity through brand orientation. Results of this study can help organizations to improve their financial performance through more awareness of the determinants of internal brand equity.

  7. The Russian Federation legislation. The new laws. Prospects for international cooperation

    International Nuclear Information System (INIS)

    Lebedev, A. YE.

    2002-01-01

    Survey of the regulatory basis for the international cooperation of the Russian Federation in the area of foreign commercial and research spent fuel management. Analysis of the latest legislative amendments. Complex approach and environmental priorities of the new legislative initiatives (three Federal laws): Amendments to Articles 1, 47 and 64 of the Federal Law on U tilization of atomic energy ; Amendments to Articles 50 of the Federal Law on E nvironmental protection ; The new Federal Law O n Special ecological programs for the clean- up of areas, contaminated by radiation . (author)

  8. The Russian Federation legislation. The new laws. Prospects for international cooperation

    Energy Technology Data Exchange (ETDEWEB)

    Lebedev, A. YE. [Department of project management TENEX, 26, Staromonetnyi Per., 109180 Moscow (Russian Federation)

    2002-07-01

    Survey of the regulatory basis for the international cooperation of the Russian Federation in the area of foreign commercial and research spent fuel management. Analysis of the latest legislative amendments. Complex approach and environmental priorities of the new legislative initiatives (three Federal laws): Amendments to Articles 1, 47 and 64 of the Federal Law on {sup U}tilization of atomic energy{sup ;} Amendments to Articles 50 of the Federal Law on {sup E}nvironmental protection{sup ;} The new Federal Law {sup O}n Special ecological programs for the clean- up of areas, contaminated by radiation{sup .} (author)

  9. 5 CFR 950.301 - National and international federations eligibility.

    Science.gov (United States)

    2010-01-01

    ... eligibility. 950.301 Section 950.301 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL... business days of the date of the request may result in a determination that the federation will not be... donations. (3) That it does not employ in its CFC operations the services of private consultants, consulting...

  10. 78 FR 40740 - Advisory Council on the Standards for Internal Control in the Federal Government

    Science.gov (United States)

    2013-07-08

    ... GOVERNMENT ACCOUNTABILITY OFFICE Advisory Council on the Standards for Internal Control in the... on the Green Book Advisory Council and the Standards for Internal Control in the Federal Government.... SUMMARY: The US Government Accountability Office (GAO) is preparing to revise the Standards for Internal...

  11. International scientists’ priorities for research on pharmaceutical and personal care products in the environment

    Science.gov (United States)

    Pharmaceuticals and personal care products (PPCPs) are widely discharged into the environment via diverse pathways. The effects of PPCPs in the environment have potentially important human and ecosystem health implications, so credible, salient, and legitimate scientific evidence...

  12. 78 FR 31944 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2013-05-28

    ... Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of...; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates... initiatives have been undertaken by regulatory authorities and industry associations to promote international...

  13. COMPARATIVE ANALYSIS OF AVAILABILITY OF THE MEDICINES FOR PRIVILEGED CATEGORIES OF CITIZENS SUFFERING FROM DIABETES MELLITUS IN THE RUSSIAN FEDERATION AND UKRAINE BASED ON THE PHARMACEUTICAL LAW

    Directory of Open Access Journals (Sweden)

    Shapovalov VV (Jr

    2015-04-01

    Full Text Available World Health Organization paid close attention to the timely detection and treatment of diabetes mellitus, since there are more than 382 million people suffering from this disease in the world. Life expectancy of patients with diabetes mellitus is twice as less when compared to their peers who do not suffer health problems and leading a healthy way of life. Based on the statistical data shows that 80% of patients on diabetes live in countries with a low standard of living. The dynamics of diabetes considered not only as a serious disease, but also as an important medical and pharmaceutical, social, economic and criminal legal problem, which is now very important for the Russian Federation, Ukraine and other countries of the world. This is because there is a constant increase in the number of patients suffering from diabetes on, with chronic diseases, the development of micro- and macrovascular complications, which lead to a reduction in life expectancy due to deterioration of its quality. At the same time the availability of the medicines for privileged categories of citizens, who suffer from diabetes mellitus in the Russian Federation and Ukraine depends on many factors. Some of these factors are improving of the management measures and control over the circulation of medicines (drugs; prevention and disease prevention; the use of personalized pharmacotherapy; ensuring the availability of essential medicines for privileged categories of citizens.Therefore, the aim of the work was to study the particularities of legal documents in Ukraine and Russia, aimed at organizing the rules regulating the circulation of the medicines used for diabetes mellitus pharmacotherapy by generalizing forensic and pharmaceutical practices related to the violation of the rights of patients with diabetes. To improve the system of measures of state control over the increasing availability of medicines for citizens of privileged contingent based on the norms of

  14. Importance of pharmaceutical laboratory compliance with international standard requirements in respect of raising their competitiveness

    Directory of Open Access Journals (Sweden)

    Božanić Vojislav N.

    2009-01-01

    Full Text Available Current Good Manufacturing Practice (cGMP being a legal regulation in developed countries will become a legal regulation in Republic of Serbia starting with March 2010. In this paper comparative analysis between requirements of standard ISO/IEC 17025 and requirements of cEU GMP is shown. Considering the fact that in Republic of Serbia no pharmaceutical industry laboratory has been accredited according to requirements of ISO/IEC 17025, while keeping in mind that more than 90% of these laboratories have not fulfilled cEU GMP requirements, this paper aimed at pointing to the possibility of fulfilling both of mentioned requirements at the same time, which would open the way to different types of interlaboratory cooperation for pharmaceutical quality control laboratories and contribute to improving competitiveness of pharmaceutical companies. Accreditation, especially in the case of pharmaceutical quality control laboratories, is important because it guaranties the level of organizational and technical competency. It could easily be said that accreditation is becoming a must in quality control of products in order for the organization to be able to gain a leading role in the global market. Both accreditation and cGMP show the organization's commitment to having products of highest quality level. Considering the above mentioned facts, it is of greatest advantage for pharmaceutical quality control laboratories to fulfill both requirements of ISO/IEC 17025 and cGMP and reach total compliance. The aim of doing this lies in an easier acceptance of pharmaceutical products in different markets, overcoming technical barriers and affirmation of quality as key factor in reaching competitiveness, while keeping in mind the importance of strategic and competitive positioning in the global market.

  15. Potential commercial use of the International Space Station by the biotechnology/pharmaceutical/biomedical sector

    Science.gov (United States)

    Morgenthaler, George W.; Stodieck, Louis

    1999-01-01

    The International Space Station (ISS) is the linch-pin of NASA's future space plans. It emphasizes scientific research by providing a world-class scientific laboratory in which to perform long-term basic science experiments in the space environment of microgravity, radiation, vacuum, vantage-point, etc. It will serve as a test-bed for determining human system response to long-term space flight and for developing the life support equipment necessary for NASA's Human Exploration and Development of Space (HEDS) enterprise. The ISS will also provide facilities (up to 30% of the U.S. module) for testing material, agricultural, cellular, human, aquatic, and plant/animal systems to reveal phenomena heretofore shrouded by the veil of 1-g. These insights will improve life on Earth and will provide a commercial basis for new products and services. In fact, some products, e.g., rare metal-alloys, semiconductor chips, or protein crystals that cannot now be produced on Earth may be found to be sufficiently valuable to be manufactured on-orbit. Biotechnology, pharmaceutical and biomedical experiments have been regularly flown on 10-16 day Space Shuttle flights and on three-month Mir flights for basic science knowledge and for life support system and commercial product development. Since 1985, NASA has created several Commercial Space Centers (CSCs) for the express purpose of bringing university, government and industrial researchers together to utilize space flight and space technology to develop new industrial products and processes. BioServe Space Technologies at the University of Colorado at Boulder and Kansas State University, Manhattan, Kansas, is such a NASA sponsored CSC that has worked with over 65 companies and institutions in the Biotech Sector in the past 11 years and has successfully discovered and transferred new product and process information to its industry partners. While tests in the space environment have been limited to about two weeks on Shuttle or a few

  16. Disinvestment and Value-Based Purchasing Strategies for Pharmaceuticals: An International Review.

    Science.gov (United States)

    Parkinson, Bonny; Sermet, Catherine; Clement, Fiona; Crausaz, Steffan; Godman, Brian; Garner, Sarah; Choudhury, Moni; Pearson, Sallie-Anne; Viney, Rosalie; Lopert, Ruth; Elshaug, Adam G

    2015-09-01

    Pharmaceutical expenditure has increased rapidly across many Organisation for Economic Cooperation and Development (OECD) countries over the past three decades. This growth is an increasing concern for governments and other third-party payers seeking to provide equitable and comprehensive healthcare within sustainable budgets. In order to create headroom for increasing utilisation, and to fund new high-cost therapies, there is an active push to 'disinvest' from low-value drugs. The aim of this article is to review how reimbursement policy decision makers have sought to partially or completely disinvest from drugs in a range of OECD countries (UK, France, Canada, Australia and New Zealand) where they are publicly funded or subsidised. We employed a systematic literature search strategy and the incorporation of grey literature known to the authorship team. We canvass key policy instruments from each country to outline key approaches to the identification of candidate drugs for disinvestment assessment (passive approaches vs. more active approaches); methods of disinvestment and value-based purchasing (de-listing, restricting treatment, price or reimbursement rate reductions, encouraging generic prescribing); lessons learnt from the various approaches; the potential role of coverage with evidence development; and the need for careful stakeholder management. Dedicated sections are provided with detailed coverage of policy approaches (with drug examples) from each country. Historically, countries have relied on 'passive disinvestment'; however, due to (1) the availability of new cost-effectiveness evidence, or (2) 'leakage' in drug utilisation, or (3) market failure in terms of price competition, there is an increasing focus towards 'active disinvestment'. Isolating low-value drugs that would create headroom for innovative new products to enter the market is also motivating disinvestment efforts by multiple parties, including industry. Historically, disinvestment has

  17. 75 FR 40843 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2010-07-14

    .... The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries... Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of... industry associations to promote international harmonization of regulatory requirements. FDA has...

  18. 77 FR 24252 - Notice of Release From Federal Grant Assurance Obligations for Sacramento International Airport...

    Science.gov (United States)

    2012-04-23

    ... Assurance Obligations for Sacramento International Airport (SMF), Sacramento, CA AGENCY: Federal Aviation... of land comprising approximately 6.50 acres of airport property at the Sacramento International Airport, California. The County of Sacramento proposes to release the 6.50 acres for sale to the...

  19. PROBLEMATIC ASPECTS OF INTERNATIONAL COOPERATION OF THE RUSSIAN FEDERATION ON THE FIGHT AGAINST CYBERCRIME

    OpenAIRE

    MAKUSHEV DMITRY IVANOVICH

    2016-01-01

    The article is devoted to topical issues of international cooperation of the Russian Federation and foreign countries in combating cybercrime. The author offers measures in international law on the improvement of cooperation between law enforcement agencies of foreign countries in the fight against computer crimes.

  20. International nuclear legislation: proposals of the Russian Federation

    International Nuclear Information System (INIS)

    Anon.

    2011-01-01

    Proposals of the Russian Federation on the amendments to Convention on early notification of a nuclear accident and to Convention on nuclear safety, as well as proposals on enhancement of IAEA safety standards are given. It is suggested to fix a provision regarding prompt and limited in time notification of the concerned State Parties of the Convention and the IAEA by a State where an accident has occurred; as well as a provision that would require making relevant information public. It is proposed to provide for the following commitment of Contracting Parties to the Convention: a Contracting Party planning to start construction of a first nuclear installation under its jurisdiction shall take, prior to commencement of the construction, all necessary steps related to long-term planning and establishment of nuclear power infrastructure, in line with the IAEA recommendations. It is pointed out the necessity of a clear procedure of coordination and interaction between a State, concerned operator and regulator. It is necessary to revise the existing design requirements with a view to consider any combination of external impacts on a nuclear installation, as well as to include adequate provisions for nuclear safety in case of such impacts

  1. The pharmaceutical sales rep/physician relationship in Turkey: ethical issues in an international context.

    Science.gov (United States)

    Tengilimoglu, Dilaver; Kisa, Adnan; Ekiyor, Aykut

    2004-01-01

    In many developed countries, the physician/pharmaceutical sales representative relationship has increasingly become the focus of ethical questions. Given this context, the purpose of the present study was to determine the ethical dilemmas faced by pharmaceutical sales representatives in Turkey in their relations with physicians, and to identify possible solutions. Through an investigator-designed questionnaire, the ethical problems perceived by 215 pharmaceutical sales representatives were quantitatively analyzed. Nearly all of the participants (96.7%) reported that they had faced ethical dilemmas in marketing drugs to physicians. The most commonly reported problems included paramedical requests (for free lab test kits, etc.) and the necessity of bargaining with physicians over the use of their firm's drugs by offering gifts and sponsorships. The participants in the study felt that physicians were the primary source of ethical problems in the marketing of drugs, and the participants' most highly ranked potential solution to these ethical problems was a better understanding, on the part of physicians, of the role of pharmaceutical sales representatives. At the end of this study, suggestions are given with a view to helping health policy makers understand and address the current controversies involving drug company representatives and physicians.

  2. Communication of 24 April 2000 received from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency

    International Nuclear Information System (INIS)

    2000-01-01

    The document reproduces the text of the Communication of 24 April 2000 received from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency, including a statement by the Ministry of Foreign Affairs of the Russian Federation in connection with the ratification by the State Duma of the Federal Assembly of the Russian Federation of the Comprehensive Nuclear Test Ban Treaty

  3. Building on the International Polar Year: Discovering Interdisciplinary Data Through Federated Search

    Directory of Open Access Journals (Sweden)

    L Yarmey

    2014-10-01

    Full Text Available The legacy of the International Polar Year 2007–2008 (IPY includes advances in open data and meaningful progress towards interoperability of data, systems, and standards. Enabled by metadata brokering technologies and by the growing adoption of international metadata standards, federated data search welcomes diversity in Arctic data and recognizes the value of expertise in community data repositories. Federated search enables specialized data holdings to be discovered by broader audiences and complements the role of metadata registries such as the Global Change Master Directory, providing interoperability across the Arctic web-of-repositories.

  4. [Poor promotional practices in pharmaceutical communication: the anti- medical visit, International experience].

    Science.gov (United States)

    Castillo Pérez, P

    1993-05-01

    We start with a short introduction about the concept of "bad promotional practices" within the Pharmaceutical Industry's (PHI) communication, giving rise to the birth of so-called "un-representatives" (un'rep). Taking the self-control model from the "Association of the British Pharmaceutical Industry" (ABPI), based upon the "code of practice" as a paradigma, we comment about those who notify presumed code's breaches besides the assessment process and penalties that are usually imposed. We also considered the possibility that sometimes the physician instead of being a prosecutor is accused, by the PHI, of supposed "Medical Deonthological Code's" Infringement. The several modalities of malpraxis during the un-rep visit are classified into four categories: product un-information; unloyal competition; echonomical temptations addressed toward physicians; and disregarding stablished visit planning. We devote most of the text to exemplarize five common and very well documented situations; promotion of non-registered indications; influence of prescriptions through prebends to doctors; doubtful payments to compensate clinical trials and drug surveillance studies; the use of exagerated claims; and the abuse of the qualification "drug of choice". We end with a self-critism, from the phi's outlook on the prudence that a "good pharmaceutical communicator" must respect. As an excellent model of wisdom, we propose doctors, Because they follow the classical good-sense picture that illustrates the process of adoption of a new drug. We emphasize the fact that product over-estimation, creating false expectatives, is--together with the lak of informative liability--one of major reasons for a drug innovation to fail.

  5. Service Quality and Satisfaction Perspectives at the 2011 International Amateur Athletic Federation (IAAF) World Championships

    Science.gov (United States)

    Kim, Min Kil; Kim, Suk-Kyu; Lee, Donghun; Judge, Lawrence W.; Huang, Haiyan

    2013-01-01

    The purpose of this exploratory study was to identify and analyze the factors that contribute to perceived service quality, user satisfaction, and behavioral intention in covering megasporting events at the Main Media Center for the International Amateur Athletic Federation (IAAF) Track and Field World Championships. The data were collected…

  6. The Rise of International Relations Programs in the Brazilian Federal Universities: Curriculum Specificities and Current Challenges

    Science.gov (United States)

    Ferreira, Marcos Alan S. V.

    2016-01-01

    The aim of this reflection is to study the new international relations (IR) programs introduced by Brazilian federal universities, looking comparatively at their curriculum specificities and current challenges. In recent years, Brazil has seen an increase of IR programs launched in several regions. Since 2003, the Ministry of Education is in the…

  7. 76 FR 35259 - Samaritan Pharmaceuticals, Inc., Seaena, Inc., Seirios International, Inc. (f/k/a Exactly...

    Science.gov (United States)

    2011-06-16

    ...., Seirios International, Inc. (f/k/a Exactly Sportswear, Inc.), et al.; Order of Suspension of Trading June... Sportswear, Inc.), Sento Corp., Shoe Pavilion, Inc., Silver Eagle Resources Ltd. (n/k/a Mercator Minerals Ltd... concerning the securities of Seirios International, Inc. (f/k/a Exactly Sportswear, Inc.) because it has not...

  8. Communication of 17 April 2000 received from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency

    International Nuclear Information System (INIS)

    2000-01-01

    The document reproduces the text of the Communication of 17 April 2000 received from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency, including a statement by the Acting President of the Russian Federation in connection with the ratification by the State Duma of the Federal Assembly of the Russian Federation of START-II Treaty and the package agreements on antimissile defence of 1997

  9. 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.

  10. Patrick Couvreur: inspiring pharmaceutical innovation.

    Science.gov (United States)

    Stanwix, Hannah

    2014-05-01

    Patrick Couvreur speaks to Hannah Stanwix, Managing Comissioning Editor: Professor Patrick Couvreur received his pharmacy degree from the Université Catholique de Louvain (Louvain-la-Neuve, Belgium) in 1972. He holds a PhD in pharmaceutical technology from the same university and completed a postdoctoral fellowship at the Eidgenössische Technische Hochschule (Zürich, Switzerland). Since 1984, Professor Couvreur has been Full Professor of Pharmacy at the Paris-Sud University (Paris, France) and was holder of the Chair of Innovation Technologique at the prestigious Collège de France (Paris, France). He has published more than 450 peer-reviewed articles and has an H-index of 73, with over 19,000 citations. Professor Coureur has been recognized by numerous national and international awards, including the 2004 Pharmaceutical Sciences World Congress Award, the prestigious Host Madsen Medal, the Prix Galien, the European Pharmaceutical Scientist Award 2011 from the European Federation of Pharmaceutical Sciences, the Médaille de l'Innovation from the Centre National de la Recherche Scientifique, and recently the European Inventor Award 2013 from the European Patent Office.

  11. 5th European Conference of the International Federation for Medical and Biological Engineering

    CERN Document Server

    European IFMBE MBEC : Cooperation for Effective Healthcare

    2012-01-01

    This volume presents the 5th European Conference of the International Federation for Medical and Biological Engineering (EMBEC),  held in Budapest, 14-18 September, 2011. The scientific discussion on the conference and in this conference proceedings include the following issues: - Signal & Image Processing - ICT - Clinical Engineering and Applications - Biomechanics and Fluid Biomechanics - Biomaterials and Tissue Repair - Innovations and Nanotechnology - Modeling and Simulation - Education and Professional

  12. [Attractiveness of France for international clinical research: 8th survey conducted by Leem (French association for pharmaceutical companies)].

    Science.gov (United States)

    Galaup, Ariane; Barthélémy, Philippe; Pouletty-Lefebvre, Brigitte; Béhier, Jehan-Michel; Zetlaoui, Jean; Borel, Thomas

    2018-04-18

    The Leem (French association of pharmaceutical companies) has conducted the eighth survey on attractiveness of France for clinical research. It serves to measure France's global competitiveness for international clinical trials and assess its strengths and areas of excellence. It also highlights the potential for progress and emerging trends at a time when the regulatory environment in France and Europe is undergoing change. This survey has been updated every two years since 2002 using the same methodology. It assesses the current status of research undertaken in France by the pharmaceutical industry between January 1st 2014 and December 31st 2015. Thirty companies (62% of the French market) have participated in this 8th survey which involved 3474 centers (versus 2860 in 2014) and 16,622 patients (versus 14,634 in 2014) enrolled in France across 586 clinical trials (versus 613 in 2014). This survey shows a reduction in the number of phase I and phase II trials. It also confirms that the studies conducted in France are primarily concerned with oncology (45%). Despite improvements across hospital contracts times (due to the adoption of the sole agreement) and performance indicators in trials (such as the number of patients enrolled by center), trial setup times in France are still overly lengthy (with stable times by French authorities). Ensuring that clinical research remains a priority issue for country is crucial for patients because of rapid access to innovation but also for the vitality of the French economy. Constructive dialogue with stakeholders on the subject of clinical research is essential to enhance the attractiveness of France and to improve the continuum between research, innovation and care. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  13. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

    Science.gov (United States)

    2010-01-21

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.

  14. Is there an improvement on the Web sites of the national and international pharmaceutical companies in Turkey? A follow-up study.

    Science.gov (United States)

    Yegenoglu, Selen; Aslan, Dilek; Sozen, Bilge

    2012-04-01

    In this follow-up study, we aimed to assess national and international pharmaceutical companies' Web sites using guidelines of The Association of Research-Based Pharmaceutical Companies (AIFD) and Pharmaceutical Manufacturers Association of Turkey (IEIS) to define whether there has been progress since 2004. We used two national guidelines in order to evaluate the Web sites of pharmaceutical companies in our study. The first guideline was from IEIS, and the second was from AIFD, which was issued recently. We collected our data between February 1 and April 30, 2011. Data analyses were performed using SPSS version 15.0. Chi squared test was done for comparing the two assessments in different years (2004 and 2011). In general, the progress that we were expecting was not satisfactory for both the international and national companies. The percentage of unmet criteria increased for "links" (from 48.0% to 52.0%) and for "mentioning the responsible person/firm for the Web site design" (from 40.6% to 59.4%) among national companies. We observed statistically significant progress only for the "information for the public" criterion (from 52.9% to 100%) among international companies. On the other hand, there was progress and a statistically significant difference in terms of not displaying any "drug ads" on the Web sites of national firms (from 55.9% to 87.5%), availability of "mail address" (from 88.2% to 100%), "telephone number" (from 88.2% to 100%), "indication of the target group" (from 23.5% to 52.1%), and "disclaimer stating the given information cannot replace a physician or pharmacist" (from 29.4% to 53.1%). Our major recommendation to pharmaceutical companies is to update their Web sites with evidence-based scientific information about themselves and their products using international and national standards. From the companies' perspective, this should be a priority responsibility based on the ethical aspect of individual and community health.

  15. PingFederate

    Data.gov (United States)

    US Agency for International Development — PingFederate Server provides Identity Federation and Single Sign On Capabilities. Federated identity management (or identity federation) enables enterprises to...

  16. Joint nuclear safety research projects between the US and Russian Federation International Nuclear Safety Centers

    International Nuclear Information System (INIS)

    Bougaenko, S.E.; Kraev, A.E.; Hill, D.L.; Braun, J.C.; Klickman, A.E.

    1998-01-01

    The Russian Federation Ministry for Atomic Energy (MINATOM) and the US Department of Energy (USDOE) formed international Nuclear Safety Centers in October 1995 and July 1996, respectively, to collaborate on nuclear safety research. Since January 1997, the two centers have initiated the following nine joint research projects: (1) INSC web servers and databases; (2) Material properties measurement and assessment; (3) Coupled codes: Neutronic, thermal-hydraulic, mechanical and other; (4) Severe accident management for Soviet-designed reactors; (5) Transient management and advanced control; (6) Survey of relevant nuclear safety research facilities in the Russian Federation; (8) Advanced structural analysis; and (9) Development of a nuclear safety research and development plan for MINATOM. The joint projects were selected on the basis of recommendations from two groups of experts convened by NEA and from evaluations of safety impact, cost, and deployment potential. The paper summarizes the projects, including the long-term goals, the implementing strategy and some recent accomplishments for each project

  17. Animal Research, the 3Rs, and the "Internet of Things": Opportunities and Oversight in International Pharmaceutical Development.

    Science.gov (United States)

    Niemi, Steven M; Davies, Gail F

    2016-12-01

    Stages of drug (and vaccine) discovery and evaluation that involve laboratory animals increasingly occur via scientific collaborations across national borders and continents. Many of these research collaborations are between asset-rich institutions and others in less wealthy parts of the world. The care and use of laboratory animals in geographically disparate locations introduces new complexities, such as different oversight requirements and available resources, as well as diverse organizational and cultural milieus. These complexities can hamper the effectiveness of local animal welfare committees and regulatory compliance, as well as compromise good science and animal welfare. At the same time, new technologies are becoming available that offer greater transparency in how these collaborations and their animal subjects are faring in real time that, in turn, can enable progress towards the 3 Rs. The focus of this essay is to identify potential rewards and risks stemming from new techniques for producing and connecting data in preclinical pharmaceutical development and consider how further social scientific investigations have the potential to enhance the benefits of international research collaborations for both human health and animal welfare. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  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. 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 ...

  20. Internal Communication in the Public Management: The Case of a Brazilian Federal Public Authority

    Directory of Open Access Journals (Sweden)

    Priscila Reinaldo Marson

    2013-03-01

    Full Text Available The intention of this article is to present a case study on the adoption and use of new channels of internal communication in a federal public autarchy. The study was conducted at the National Institute of Social Security, in São Paulo, between July 2008 and July 2009, and aimed to monitor the period in which a new internal communication plan was developed and implemented in its initial phase. The research methodology used was the case study, consisting of documentary analysis, field research and in-depth interviews conducted with the institution’s public employees. As a result, it was possible to observe the internal resistance and the difficulties encountered in the management of the new plan. Among its conclusions, the study highlights the need for a previous study on the conditions of relationships and practices developed in a public service unit at the adoption of new communication tools. It also highlights the importance of planning and management actions in the implementation of the intended communication actions, including internal marketing efforts to sensitize users about the meaning and importance of internal communication in promoting greater agility and efficiency in the workplace, in order to offer best public services to users.

  1. Informed consent: Enforcing pharmaceutical companies' obligations abroad.

    Science.gov (United States)

    Lee, Stacey B

    2010-06-15

    The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections.

  2. From France to the World: The International Federation of Organic Agriculture Movements (IFOAM

    Directory of Open Access Journals (Sweden)

    John Paull

    2010-12-01

    Full Text Available The formation of the International Federation of Organic Agriculture Movements (IFOAM at Versailles, France, in 1972 set organic food and farming on a strong future trajectory. It was an initiative of France’s Nature et Progrès, and driven by its then President, Roland Chevriot. IFOAM was founded with the support of a small cluster of kindred organisations: Rodale Press of the USA; the Soil Association of the UK; the Soil Association of South Africa; and the Swedish Biodynamic Association. None of these five organisations bore the term ‘organic’ in their title, nevertheless, the choice of name acknowledged ‘organic’ as the term to signify their common cause. It secured ‘organic’ as the core narrative element and as the international descriptor of what is now a clearly identifiable and differentiated segment of the global food and farming sector. From the outset ‘biodynamic’ was accepted as a special case of ‘organic’. The formation of IFOAM created an entity which united the aspirations, the philosophies and the hopes of disparate groups each with roles primarily restricted to national advocacy. IFOAM has grown to a federation of 804 organisations from 111 counties. Organic production statistics are now reported by IFOAM from 154 countries and organic sector retail sales are reported to be US$51b annually. IFOAM is based in Bonn, Germany, and as the global umbrella advocacy group for the organic sector it is without peer.

  3. 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

  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. Brave and angry--the creation and development of the International Planned Parenthood Federation (IPPF).

    Science.gov (United States)

    Claeys, Vicky

    2010-12-01

    This paper looks back on the developments in thinking from birth control, through voluntary family planning, to a comprehensive approach to sexual and reproductive health and rights (SRHR), and celebrates some of the key players in this evolution. It tells the story of the creation of the International Planned Parenthood Federation (IPPF) in 1952, and scrutinises how important this organisation was then and is now. It gives an idea of the efforts it took to reassemble initiatives around the world into one body, strong enough to foster the cause to the benefit of all. While IPPF was and still is a unique association, it has increased its partnerships and works together with a multitude of organisations active in the field of SRHR. In the current political context joint efforts are still needed to protect the universally recognised human right of people to decide freely and responsibly on the number and spacing of their children, and their access to adequate education and information.

  6. 6th European Conference of the International Federation for Medical and Biological Engineering

    CERN Document Server

    Vasic, Darko

    2015-01-01

    This volume presents the Proceedings of the 6th European Conference of the International Federation for Medical and Biological Engineering (MBEC2014), held in Dubrovnik September 7 – 11, 2014. The general theme of MBEC 2014 is "Towards new horizons in biomedical engineering" The scientific discussions in these conference proceedings include the following themes: - Biomedical Signal Processing - Biomedical Imaging and Image Processing - Biosensors and Bioinstrumentation - Bio-Micro/Nano Technologies - Biomaterials - Biomechanics, Robotics and Minimally Invasive Surgery - Cardiovascular, Respiratory and Endocrine Systems Engineering - Neural and Rehabilitation Engineering - Molecular, Cellular and Tissue Engineering - Bioinformatics and Computational Biology - Clinical Engineering and Health Technology Assessment - Health Informatics, E-Health and Telemedicine - Biomedical Engineering Education

  7. Nuclear safety research collaborations between the U.S. and Russian Federation International Nuclear Safety Centers

    International Nuclear Information System (INIS)

    Hill, D. J.; Braun, J. C.; Klickman, A. E.; Bougaenko, S. E.; Kabonov, L. P.; Kraev, A. G.

    2000-01-01

    The Russian Federation Ministry for Atomic Energy (MINATOM) and the US Department of Energy (USDOE) have formed International Nuclear Safety Centers to collaborate on nuclear safety research. USDOE established the US Center (ISINSC) at Argonne National Laboratory (ANL) in October 1995. MINATOM established the Russian Center (RINSC) at the Research and Development Institute of Power Engineering (RDIPE) in Moscow in July 1996. In April 1998 the Russian center became a semi-independent, autonomous organization under MINATOM. The goals of the center are to: Cooperate in the development of technologies associated with nuclear safety in nuclear power engineering; Be international centers for the collection of information important for safety and technical improvements in nuclear power engineering; and Maintain a base for fundamental knowledge needed to design nuclear reactors. The strategic approach is being used to accomplish these goals is for the two centers to work together to use the resources and the talents of the scientists associated with the US Center and the Russian Center to do collaborative research to improve the safety of Russian-designed nuclear reactors. The two centers started conducting joint research and development projects in January 1997. Since that time the following ten joint projects have been initiated: INSC databases--web server and computing center; Coupled codes--Neutronic and thermal-hydraulic; Severe accident management for Soviet-designed reactors; Transient management and advanced control; Survey of relevant nuclear safety research facilities in the Russian Federation; Computer code validation for transient analysis of VVER and RBMK reactors; Advanced structural analysis; Development of a nuclear safety research and development plan for MINATOM; Properties and applications of heavy liquid metal coolants; and Material properties measurement and assessment. Currently, there is activity in eight of these projects. Details on each of these

  8. V International Golden Horde Forum (Kazan, Russian Federation, March 15–18, 2017

    Directory of Open Access Journals (Sweden)

    E.G. Sayfetdinova

    2017-09-01

    Full Text Available M.A.Usmanov Center for Research on the Golden Horde and Tatar Khanates of Sh.Marjani Institute of History of Tatarstan Academy of Sciences became the organizer of a major international academic event aimed at highlighting the source study of the history of the Golden Horde and the Turkic-Tatar khanates. The fifth international Golden Horde Forum was held in Kazan on March 15–18, 2017, which was attended by researchers from 18 countries: Russia, USA, France, England, Mongolia, Finland, Serbia, Kazakhstan, Ukraine, etc. Two international conferences and two round tables were held in the framework of the Forum. The first research conference “Source Study of the History of the Golden Horde and Tatar Khanates: Textology, Translations, Interpretations” wad dedicated to important issues of source study of the history of the Golden Horde and the Turkic-Tatar khanates. The second research conference was dedicated to the topic “Coinage and Money Circulation in the Golden Horde and Turkic-Tatar Khanates in the Light of Source Studies”. The round table “Ecological and Epidemic Factor in Medieval Eurasia” was the third research event in the framework of the Forum. The round table “The Golden Horde on the Great Silk Road” was organized on March 16, 2017 in conjunction with the Council of Muftis of the Russian Federation. When summing up the results of the Forum, participants noted that all events were held at a high scholarly level, contributed to the strengthening of international academic relations and made it possible to make substantial progress in solving actual research problems and to outline the prospects for further research.

  9. IPPF Charter on Sexual and Reproductive Rights. International Planned Parenthood Federation.

    Science.gov (United States)

    Newman, K; Helzner, J F

    1999-05-01

    For most of human existence and in most societies, women have been considered to be property and subject to men. Throughout history, with such notable exceptions as Queen Boadicea, Eleanor of Aquitaine, Elizabeth I of England, and Catherine the Great of Russia, women had little or no power until early in the 20th century when the women's suffrage movement was successful in the United States and in some European countries. As women have gained political rights, groups of women have sought sexual and reproductive rights, as exemplified by the feminist movement of the past few decades in the United States. Although marked strides toward achievement of reproductive choice have been taken in high-income countries, there remain major strictures to reproductive freedom for women in low-income countries. This area, which is replete with ethical and moral issues, has been addressed by the International Planned Parenthood Foundation (IPPF), which has worked to improve the sexual and reproductive health of women throughout the world. The IPPF Charter on Sexual and Reproductive Rights is a paradigm for both women's rights and human rights. Karen Newman is policy adviser with the IPPF and has codrafted the IPPF Charter on Sexual and Reproductive Rights together with two lawyers. She has held several positions within the IPPF, including medical researcher, press officer, and programme adviser in Europe, where she had responsibility for working with new family planning associations (FPAs) in the Czech Republic and Slovakia. At present, she is working to increase the capacity of IPPF member FPAs to undertake human rights-based advocacy for sexual and reproductive health and rights. Judith F. Helzner is director of Sexual and Reproductive Health at International Planned Parenthood Federation/Western Hemisphere Region, Inc., where she has worked since 1987. She holds M.A. degrees from the University of Pennsylvania in International Relations and Demography. Her previous employment

  10. Nuclear safety research collaborations between the US and Russian Federation international nuclear safety centers

    International Nuclear Information System (INIS)

    Hill, D.J; Braun, J.C; Klickman, A.E.; Bugaenko, S.E; Kabanov, L.P; Kraev, A.G.

    2000-01-01

    The Russian Federation Ministry for Atomic Energy (MINATOM) and the U.S. Department of Energy (USDOE) have formed International Nuclear Safety Centers to collaborate on nuclear safety research. USDOE established the U. S. Center at Argonne National Laboratory in October 1995. MINATOM established the Russian Center at the Research and Development Institute of Power Engineering in Moscow in July 1996. In April 1998 the Russian center became an independent, autonomous organization under MINATOM. The goals of the centers are to: cooperate in the development of technologies associated with nuclear safety in nuclear power engineering. be international centers for the collection of information important for safety and technical improvements in nuclear power engineering. maintain a base for fundamental knowledge needed to design nuclear reactors.The strategic approach that is being used to accomplish these goals is for the two centers to work together to use the resources and the talents of the scientists associated with the US Center and the Russian Center to do collaborative research to improve the safety of Russian-designed nuclear reactors

  11. Disparities in psychosocial cancer care: a report from the International Federation of Psycho-oncology Societies.

    Science.gov (United States)

    Grassi, Luigi; Fujisawa, Daisuke; Odyio, Philip; Asuzu, Chioma; Ashley, Laura; Bultz, Barry; Travado, Luzia; Fielding, Richard

    2016-10-01

    The aim of the study was to understand the characteristics of the International Federation of Psycho-oncology Societies (FPOS) and possible disparities in providing psychosocial care in countries where psycho-oncology societies exist. A survey was conducted among 29 leaders of 28 countries represented within the FPOS by using a questionnaire covering (i) characteristics of the society; (ii) characteristics of the national health care system; (iii) level of implementation of psycho-oncology; and (iv) main problems of psycho-oncology in the country. Twenty-six (90%) FPOS returned the questionnaires. One-third reported to have links with and support from their government, while almost all had links with other scientific societies. The FPOS varied in their composition of members' professions. Psychosocial care provision was covered by state-funded health services in a minority of countries. Disparities between countries arose from different causes and were problematic in some parts of the world (eg, Africa and SE Asia). Elsewhere (eg, Southern Europe and Eastern Europe), austerity policies were reportedly responsible for resource shortages with negative consequences on psychosocial cancer care. Half of FPOS rated themselves to be integrated into mainstream provision of care, although lack of funding was the most common complain. The development and implementation of psycho-oncology is fragmented and undeveloped, particularly in some parts of the world. More effort is needed at national level by strong coalitions with oncology societies, better national research initiatives, cancer plans, and patient advocacy, as well as by stronger partnership with international organizations (eg, World Health Organization and Union for International Cancer Control). Copyright © 2016 John Wiley & Sons, Ltd.

  12. H.E. Mr Leonid A. Skotnikov, Ambassador, Permanent Representative of the Russian Federation to the United Nations and other International Organisations in Geneva

    CERN Multimedia

    Patrice Loïez

    2003-01-01

    Photo 01: H.E. Mr Leonid A. Skotnikov, Ambassador of the Russian Federation to the United Nations and other International Organisations in Geneva (centre) with (from left to right) F. Grishaev, Adviser, Mission of the Russian Federation and R. Cashmore. Photo 02: H.E. Mr Leonid A. Skotnikov, Ambassador of the Russian Federation to the United Nations and other International Organisations in Geneva (right) with F. Grishaev, Adviser, Mission of the Russian Federation.

  13. [Monitoring of a protocol for the adequacy of the pharmaceutical form of the oral medication to the degree of dysphagia in patients hospitalized in an internal medicine service].

    Science.gov (United States)

    García Aparicio, J; Herrero Herrero, J I; Moreno Gómez, A Ma; Martínez Sotelo, J; González del Valle, E; Fernández de la Fuente, Ma A

    2011-01-01

    The oral route is the most convenient way of administering medication, although it may not be safe. Dysphagia is one of the factors rendering difficult a proper feeding and administration of medication. to improve the administration of oral medication in patients with dysphagia by changing the pharmaceutical formulation of the principles prescribed to tolerable textures. Pilot project for the application of a dysphagia protocol that included the patients admitted to the Internal Medicine Unit at Los Montalvos Center for 4 months. After detecting the suspicion of dysphagia, a dysphagia-viscosity test was applied to know the tolerated textures. Then, the pharmaceutical formulations were adapted and the manipulation instructions for the drugs were indicated for their proper administration. 23 out of 627 admitted patients were included, with a mean age of 85 years (σ±7.4). The pathologies implicated in dysphagia were: dementia (65.2%); cerebrovascular disease (30.4%), and Parkinson's disease (4.4%). The best texture for drug intake was a "pudding" in 48.0%. 43 active ingredients were reviewed and 134 interventions were performed: in 41% of the cases, swallowing was made easier by mixing the drug with the food and in 59% water and a thickener were used. 94% of the recommendations were considered to be appropriate. the adaptation of the pharmaceutical formulations to the degree of dysphagia impacts on the improvement of healthcare quality by implementing safety in drug prescription and administration processes.

  14. H.E. Mr Leonid A.Skotnikov Ambassador,PermanentRepresentative of the Russian Federation to the United Nations and other International Organisations in Geneva

    CERN Multimedia

    Patrice Loïez

    2003-01-01

    Photo 01: H.E. Mr Leonid A. Skotnikov, Ambassador of the Russian Federation to the United Nations and other International Organisations in Geneva (right) with CERN Director-General, L. Maiani. Photo 02: Mr Leonid A. Skotnikov, Ambassador of the Russian Federation to the United Nations and other International Organisations in Geneva. Photo 03: Mr Leonid A. Skotnikov, Ambassador of the Russian Federation to the United Nations and other International Organisations in Geneva (right) with CERN Director-General, L. Maiani.

  15. World Federation for Medical Education Policy on international recognition of medical schools' programme.

    Science.gov (United States)

    Karle, Hans

    2008-12-01

    The increasing globalisation of medicine, as manifested in the migration rate of medical doctors and in the growth of cross-border education providers, has inflicted a wave of quality assurance efforts in medical education, and underlined the need for definition of standards and for introduction of effective and transparent accreditation systems. In 2004, reflecting the importance of the interface between medical education and the healthcare delivery sector, a World Health Organization (WHO)/World Federation for Medical Education (WFME) Strategic Partnership to improve medical education was formed. In 2005, the partnership published Guidelines for Accreditation of Basic Medical Education. The WHO/WFME Guidelines recommend the establishment of proper accreditation systems that are effective, independent, transparent and based on medical education-specific criteria. An important prerequisite for this development was the WFME Global Standards programme, initiated in 1997 and widely endorsed. The standards are now being used in all 6 WHO/WFME regions as a basis for quality improvement of medical education throughout its continuum and as a template for national and regional accreditation standards. Promotion of national accreditation systems will have a pivotal influence on future international appraisal of medical education. Information about accreditation status - the agencies involved and the criteria and procedure used - will be an essential component of new Global Directories of Health Professions Educational Institutions. According to an agreement between the WHO and the University of Copenhagen (UC), these Directories (the Avicenna Directories) will be developed and published by the UC with the assistance of the WFME, starting with renewal of the WHO World Directory of Medical Schools, and sequentially expanding to cover educational institutions for other health professions. The Directories will be a foundation for international meta-recognition ("accrediting the

  16. Pharmaceutical policies for the Third World--whose responsibility?

    Science.gov (United States)

    1983-07-16

    Several developing countries, such as Bangladesh, Cuba, India, and Mozambique, are currently formulating national pharmaceutical policies to reduce expenditures on drugs while increasing their availability to those in greatest need. 5 components of such national policies have been identified: 1) elimination of ineffective and inappropriate preparations through concentrating on a selection such as the World Health Organization's 200 "basic and essential drugs", coupled with national drug pricing policies that discriminate between essential drugs and non-essential or luxury drugs; 2) public systems of drug distribution which would reduce costs to the consumer; 3) importation of the limited number of drugs distributed through the public system in bulk, which might reduce costs by 20-25%; 4) use of generic rather than brand name drugs; and 5) establishment of domestic pharmaceutical industries within developing countries to encourage research into drugs for local health problems, reduce use of foreign exchange to import drugs, and increase local self-reliance in dealing with disease. In November 1982, Health Action International, a coordinating body for more than 50 publish interest groups seeking to promote rational use of pharmaceuticals, presented a draft internationl code on pharmaceuticals to the UN Conference on Trade and Development. A voluntary code produced in 1981 by the International Federation of Pharmaceutical Manufacturers' Associations paid little attention to monitoring and enforcement. Little progress has been made, and the need for sensible policy making at the international and national levels has long been apparent.

  17. Internal social responsibility: the perception of the public servants from a federal institution

    International Nuclear Information System (INIS)

    Laranja, Leticia Cruz

    2017-01-01

    The paper aims to analyze the perception of public servants from a federal autarchy regarding its practices, actions and Corporate Social Responsibility programs towards its servants, as well as proposing improvements. Thus, a revision of the existing literature on the evolution of Corporate Social Responsibility was carried out, as well as its applications on the public sector and inside its organizations. The quantitative-descriptive research was performed from a survey using a closed questionnaire developed from the Ethos Indicators focused on workforce. The research results indicated the dominance of a negative perception by the servants regarding Internal Social Responsibility practices in the autarchy, as well as the dominant negative perception from servants without leadership positions and with shorter length of service against the point of view of servants that occupy leadership positions and with longer length of service. The research allowed the identification of practices related to Working Conditions, Working Day and Life Quality as being more relevant, and practices regarding Unions Relations as being the least relevant for servants. In order to improve the perception of the servants on the issues evaluated negatively it is recommended to developed actions and programs related to professional development, employability and retirement, health and safety, working conditions and life quality, and to developed actions aimed at employees without leadership positions and with shorter length of service, whose perceptions were more negative. (author)

  18. History and current activities of the International Diabetes Federation-Western Pacific Region (IDF-WPR).

    Science.gov (United States)

    Baba, S

    1994-10-01

    International Diabetes Federation (IDF) is one of the biggest non-governmental organizations with its 44-year history since 1950. In 1993, 114 diabetes associations in 96 countries participated in the IDF. In 1982, it was decided to divide the globe into seven regions and to promote the diagnosis, treatment, care and education of diabetes based on the environment, natural features, culture and race of the each region. On January 24, 1984, the IDF-WPR establishment meeting was held in Melbourne, Australia, with eight original member countries (Australia, New Zealand, Korea, The Philippines, Malaysia, Singapore, Fiji and Japan). In 1993, 13 diabetes associations in 12 countries joined the IDF-WPR. New member associations are from China (Beijing and Taipei), Hong Kong, Papua New Guinea and Indonesia. The IDF-WPR has been holding congresses and council meetings every 3 or 4 years since 1984 as well as formulating strategic action plans in the scientific, clinical, health care and education fields of diabetes.

  19. 11th International Federation of Automatic Control (IFAC) Workshop on Time-Delay Systems

    CERN Document Server

    Fridman, Emilia; Sename, Olivier; Dugard, Luc

    2016-01-01

    This book mostly results from a selection of papers presented during the 11th IFAC (International Federation of Automatic Control) Workshop on Time-Delay Systems, which took place in Grenoble, France, February 4 - 6, 2013.  During this event, 37 papers were presented. Taking into account the reviewers' evaluation and the papers' presentation the best papers have been selected and collected into the present volume. The authors of 13 selected papers were invited to participate to this book and provided a more detailed and improved version of the conference paper. To enrich the book, three more chapters have been included from specialists on time-delay systems who presented their work during the 52nd IEEE Conference on Decision and Control, which held in December 10 - 13, 2013, at Florence, Italy. The content of the book is divided into four main parts as follows: Modeling, Stability analysis, Stabilization and control, and Input-delay systems. Focusing on various topics of time-delay systems, this book will be...

  20. Bariatric surgery for diabetes: the International Diabetes Federation takes a position.

    Science.gov (United States)

    Dixon, John B; Zimmet, Paul; Alberti, K George; Mbanya, Jean Claude; Rubino, Francesco

    2011-12-01

    Type 2 diabetes (T2D) and obesity are both complex and chronic medical disorders, each with an escalating worldwide prevalence. When obesity is severe, and/or available medical therapies fail to control the diabetes, bariatric surgery becomes a cost-effective therapy for T2D. When there are other major comorbidities and cardiovascular risk, the option of bariatric surgery becomes even more worthy of consideration. National guidelines for bariatric surgery need to be developed and implemented for people with T2D. With this in mind, the International Diabetes Federation convened a multidisciplinary working group to develop a position statement. The key recommendations cover describing those eligible for surgery and who should be prioritized, incorporating bariatric surgery into T2D treatment algorithms, performing surgery in centers with multidisciplinary teams that are experienced in the management of both obesity and diabetes, and developing bariatric surgery registries and reporting standards. © 2011 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Blackwell Publishing Asia Pty Ltd.

  1. Walking the Line: Canadian Federalism, the Council of Ministers of Education, and the Case of International Education, 1970-1984

    Science.gov (United States)

    Allison, John

    2007-01-01

    This article will examine Canadian politicians' and administrators' leadership in the realm of education-related international activities. In the era between the 1960s and the 1980s, it became increasingly difficult for educational leaders to walk the line dividing federal and provincial responsibility in this field. Educational authorities at the…

  2. Communication received on 10 May 1999 from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency

    International Nuclear Information System (INIS)

    1999-01-01

    The document reproduces the text of a communication received on 10 May 1999 from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency, with regard to the resolution adopted by the 42nd Agency General Conference, entitled 'The safety of radiation sources and the security of radioactive materials' (GC(42)/RES/12), in connection with the war in Yugoslavia

  3. Source index A: Federal law, without agreements under international law. As of December 31, 1994

    International Nuclear Information System (INIS)

    1995-01-01

    The Federal Law Catalogue and relevant sources - BGBl. III - is the basis of the source index A, which from 1st January 1966 onwards publishes the sources of laws and statutes announced in the Federal Law Gazette, part I and part II, as well as in the Federal Gazette. The source index A covers the sources of all statutes and amendments since 1st January 1964. Official directives, however, are not always announced in the Federal Law Gazette, or in the promulgation section of the Federal Gazette, but rather in the official journals of the Federal Ministries, and in the announcement section of the Federal Gazette. This also applies to amendments or cancellations of directives first published in the Federal Law Gazette or in the promulgation section of the Federal Gazette. As the latter and the official journals on the ministries are not scanned for the source index A, there is no guarantee as to complete coverage of directives. Subject scope 75 covers acts and directives relating to mining, nuclear energy, electricity, gas and power supply. (orig.) [de

  4. Relationships of nuclear, architectural and International Federation of Gynecology and Obstetrics grading systems in endometrial cancer.

    Science.gov (United States)

    Toptaş, Tayfun; Peştereli, Elif; Bozkurt, Selen; Erdoğan, Gülgün; Şimşek, Tayup

    2018-03-01

    To examine correlations among nuclear, architectural, and International Federation of Gynecology and Obstetrics (FIGO) grading systems, and their relationships with lymph node (LN) involvement in endometrioid endometrial cancer. Histopathology slides of 135 consecutive patients were reviewed with respect to tumor grade and LN metastasis. Notable nuclear atypia was defined as grade 3 nuclei. FIGO grade was established by raising the architectural grade (AG) by one grade when the tumor was composed of cells with nuclear grade (NG) 3. Correlations between the grading systems were analyzed using Spearman's rank correlation coefficients, and relationships of grading systems with LN involvement were assessed using logistic regression analysis. Correlation analysis revealed a significant and strongly positive relationship between FIGO and architectural grading systems (r=0.885, p=0.001); however, correlations of nuclear grading with the architectural (r=0.535, p=0.165) and FIGO grading systems (r=0.589, p=0.082) were moderate and statistically non-significant. Twenty-five (18.5%) patients had LN metastasis. LN involvement rates differed significantly between tumors with AG 1 and those with AG 2, and tumors with FIGO grade 1 and those with FIGO grade 2. In contrast, although the difference in LN involvement rates failed to reach statistical significance between tumors with NG 1 and those with NG 2, it was significant between NG 2 and NG 3 (p=0.042). Although all three grading systems were associated with LN involvement in univariate analyses, an independent relationship could not be established after adjustment for other confounders in multivariate analysis. Nuclear grading is significantly correlated with neither architectural nor FIGO grading systems. The differences in LN involvement rates in the nuclear grading system reach significance only in the setting of tumor cells with NG 3; however, none of the grading systems was an independent predictor of LN involvement.

  5. The trends and constructive ambiguity in international agreements on intellectual property and pharmaceutical affairs: Implications for domestic legislations in low- and middle-income countries.

    Science.gov (United States)

    Son, Kyung-Bok; Lee, Tae-Jin

    2017-06-06

    The purpose of this study is to analyse the trends in international agreements including Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Korea-United States Free Trade Agreements, and Trans-Pacific Partnership Agreements on intellectual property and pharmaceutical affairs with the updated framework. The study also assesses constructive ambiguity in international agreements, which might affect the implementation process through interpretation and domestic legislations. Five flexibility clauses and three TRIPS-plus provisions were selected, and presence of constructive ambiguity in the agreements was analysed to draw actual trends in international agreements. Flexibility provisions excluding compulsory licensing were not noticeably changed, and TRIPS-plus provisions including data exclusivity and patent linkage were expanded in scope or newly appeared, respectively. The clause regarding compulsory licensing, extension of the patent term, data exclusivity, and patent linkage showed unclear definitions or the lack of adequate explanations. With constructive ambiguity in those clauses, a country who wants to join international agreements in the near future could amend domestic legislations to minimise the detrimental effect of international agreements on access to medicines.

  6. The argument for pharmaceutical policy.

    Science.gov (United States)

    Traulsen, Janine Morgall; Almarsdóttir, Anna Birna

    2005-02-01

    Pharmaceutical policy is a global concern. It has become a hot political topic in most countries--developed as well as developing--and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it be understood, discussed and debated within the pharmacy profession and included in the curriculum of schools of pharmacy. This, the first article in a series, argues for the importance of the academic discipline of pharmaceutical policy analysis and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how pharmaceutical policy is made; pharmaceutical policy as a dynamic process; and the new public health as a global issue. The article ends with a short description of the remaining five articles in the series which will deal with important aspects of pharmaceutical policy. The topics include: economic pressures on health care systems; drug utilization from the clinical viewpoint (rational use of medicines); the impact of pharmaceutical policy on patients and the patient impact on pharmaceutical policy; the professional perspective; and finally the last article which deals with studying and evaluating pharmaceutical policy.

  7. HIV/AIDS, health and wellbeing study among International Transport Workers' Federation (ITF) seafarer affiliates.

    Science.gov (United States)

    Altaf Chowdhury, Syed Asif; Smith, Jacqueline; Trowsdale, Steve; Leather, Susan

    2016-01-01

    Transport workers generally face a higher-than-average risk of HIV as well as other health challenges. In order to improve understanding of health issues in the maritime sector, including but not limited to HIV/AIDS, and to prepare appropriate responses the International Transport Workers' Federation (ITF) conducted a study of the views and needs of those affiliates. The ITF carried out two surveys. The first consisted of a questionnaire sent to all ITF seafarer affiliates to establish their concerns about health issues, including the impact of HIV/AIDS, and to assess the extent and nature of existing trade union programmes. The second consisted of a knowledge, attitude and behaviour survey on health, wellbeing and AIDS among a cross-section of individual members administered through anonymous and confidential questionnaires by maritime affiliates in four countries in different regions and an identical online questionnaire through Survey Monkey. For the first survey, replies were received from 35 unions in 30 countries, including major seafarer supplying countries - India, Indonesia, Myanmar, Philippines, Turkey, Ukraine - and major beneficial ownership countries such as Germany, Italy, Norway, and South Korea. Health issues of concern included HIV and other sexually transmitted infections for over three-quarters of them, and then alcohol use, weight control, and mental health. All said they would welcome ITF support in starting or strengthening a programme on general health and/or HIV. Replies were received to the second survey from 615 individual seafarers. Half to three-quarters said they worried about their weight, lack of exercise and drinking; over half felt depressed sometimes or often. There were serious knowledge gaps in a number of areas, especially HIV transmission and prevention, as well as high levels of stigma towards workmates with HIV. A number of health issues and information gaps remain unaddressed on board and pre-departure. Mental health is

  8. The Effect of Job Characteristic, Welfare and Work Environment to Employee Performance at PT. Federal International Finance Manado

    OpenAIRE

    Walangitan, Mac Donald; Mandey, S. L.; Tulandi, Christy

    2015-01-01

    Job characteristic is the determinant of the fit between person with a particular line of work that explored. Welfare is the remuneration provided by the company based on the company rules. Work environment is physical and non-physical workplaces that have direct effect on employee. The purpose of this study is to determine the influence of job characteristic, welfare and work environment on employee performance at PT. Federal International Finance Manado. The population in the study is 65 e...

  9. 51st and 52nd annual meeting of the Protection Committee of the Federal Ministry of Internal Affairs. Lectures

    International Nuclear Information System (INIS)

    2005-01-01

    This volume summarizes the presentations of both yearly meetings 2002 and 2003. The presentations 2002 cover the following subjects: disaster defence concept of the Land Hesse from a medical perspective, integration of the public health service into the field of catastrophic medical supply, reaction in case of anthrax incidents, pharmaceutical residues in sewage plants, waters and drinking water, international emergency case exercise '' JINEX 1'', provision of information in case of a catastrophe. The presentations 2003 cover the following subjects: joint procedures in order to improve the cooperation in the field of civil defence and the alarm and information centre of the European Committee, perspectives for the integration of the public health service into the field of catastrophic medical supply, threat of biological and chemical substances, increase of the defence readiness in the field of disaster defence. (uke) [de

  10. Internal Variations in Health-care Federalism in Canada and the United States

    Directory of Open Access Journals (Sweden)

    Vandna Bhatia

    2014-12-01

    Full Text Available Federal systems are prone to dividing health benefits inconsistently across subnational jurisdictions. In this article, we examine how federalism intersects with economic and social factors, particularly gender and immigration status, to create structural barriers to accessing and receiving necessary healthcare. Drawing on insights from the historical institutionalist literature and the experiences of immigrant women in the Canadian and American health systems, we find significant subnational variations in access to health services and insurance coverage. Gaps in service – which are filled (if at all by costly, inaccessible private provision – are the product of piecemeal policymaking, as new programs and services are layered onto existing systems which are themselves outdated and anachronistic. Our analysis demonstrates the need to move beyond analyses of federal state architectures to an intersectional approach to better understand the differential negative impact of subnational variations on equity between social groups and their ability to access to basic health services.

  11. The Evaluation of Internal Control Implementation Over Merchandise Inventory at PT. Suramando (Pharmaceutical Distributors and General Suppliers) in Manado

    OpenAIRE

    Runtu, Treesje; Seredei, Srijantri

    2015-01-01

    Inventory is a firms current assets, that its amount is material and constituting one of essential factor in the corporate operational activity. That is why a good internal controls to must be done secure supplies from the acts of fraud, deviation and damage. The purpose of this study is to evaluate the internal control over merchandise inventory at PT. Suramando it is running well. The method used is qualitative method through descriptive analysis. The final conclusion is that based on the e...

  12. Federal Administrative Court, judgement of December 17, 1986 (nuclear power station at international border)

    International Nuclear Information System (INIS)

    Anon.

    1987-01-01

    In its decision of December 17, 1986, the Federal Administrative Court accepted the right of action of Dutch borderers against an atomic licence for a German nuclear power plant. The necessary involvement according to sec. 42 Paragraph 2 of the Administrative Court Procedure Act results from the violation of the third party protection provision in sec. 7 Atomic Energy Act. (WG) [de

  13. The application of private international law in the field of labor relationship complicated by a foreign element in the Russian Federation

    Directory of Open Access Journals (Sweden)

    Matorina T.A.

    2017-02-01

    Full Text Available the article analyzes urgent issues of application of international law in the field of labor relations. The inclusion of international law in the Russian legal system has become a necessity because at the present time the most universally recognized norms of international law and international treaties can actually be achieved and implemented solely through the judicial system. The main domestic legal norm permitting courts of the Russian Federation to be guided by the provisions contained in international law is set out in part 4 of article 15 of the Constitution of the Russian Federation.

  14. Drenagem interna como fator de diferenciação de Latossolos do Distrito Federal The internal drainage as a differentiation factor in Oxisols of Distrito Federal, Brazil

    Directory of Open Access Journals (Sweden)

    Patrícia Maurício Campos

    2010-03-01

    , the water-table oscillation was monitored using 2.5-m depth observation wells, during one year. The studied Oxisols were considered chemically and physically similar. However, they differed as to morphological and mineralogical characterization, with the presence of concretionary horizons and goethite in the LVA. Goethite stability in this soils was influenced by the water-table oscillation. The presence of concretionry horizons in LVA caused an internal drainage deficiency, which resulted in lower saturated hydraulic conductivity and lower variation of the water-table levels. Therefore, LVA soils show lower agricultural potential than LV ones, in Distrito Federal. Oxisols physicohydric characteristics have little influence on soil diagnostic attributes, except for iron oxides mineralogy, which show increased contents of goethite in low internal drainage conditions.

  15. The Purpose and Scope of Pedagogy in Pharmaceutical Education.

    Science.gov (United States)

    Nakamura, Akihiro

    2017-01-01

    The WHO and International Pharmaceutical Federation (FIP) introduced the concept of the "seven-star pharmacist" in which a pharmacist is described as a caregiver, communicator, decision-maker, teacher, lifelong learner, leader and manager. In six-year pharmaceutical education programs, which have been provided in schools of pharmacy since 2006, 5th year students participate in on-site practice experiences in hospitals and community pharmacies. Thus, Japanese pharmacists also began to have a role in pharmaceutical education as teachers in clinical settings. Not only pharmacists in clinical settings, but also faculty members of pharmacy schools, had not previously been familiar with evidence-based education, and therefore they often teach in the way they were taught. Since research on teaching and learning has not been well developed in Japanese pharmaceutical education, both the model core curriculum for six-year programs and the subject benchmark statement for four-year programs are based on insufficient scientific evidence. We should promote the scholarship of teaching and learning, which promotes teaching as a scholarly endeavor and a worthy subject for research. In this review, I will summarize the needs and expectations for the establishment of pedagogy in pharmaceutical education.

  16. Voluntary league of peoples vs. coercive world federative state (Völkerstaat/Staatenverein of peoples as states: Kant's and Rawls' considerations concerning international relations: Similarities and

    Directory of Open Access Journals (Sweden)

    Stupar Milorad J.

    2004-01-01

    Full Text Available Although similar in some respects, Rawls' and Kant' visions of world order fall apart on the question of sovereignty. Rawls never advocates of an international single state with international authority. Kant, on the other hand, inspired by the project of Enlightenment, as a final form of international sovereignty sees federative state of states as a provider for eternal peace among peoples.

  17. Text of communication of 14 November 2000 received from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency concerning nuclear disarmament

    International Nuclear Information System (INIS)

    2000-01-01

    The Director General has received a communication dated 14 November 2000 from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency concerning nuclear disarmament, attaching a statement by the President of the Russian Federation. The text of the communication and, as requested therein, the text of the President of the Russian Federation, are attached hereto for the information of Member States

  18. Analysis of Russian Federation Foreign Policy in the Field of International Information Security

    Directory of Open Access Journals (Sweden)

    Elena S. Zinovieva

    2014-01-01

    Full Text Available Information and communication technologies (ICT play an essential role in the improvement of the quality of life, economic and socio-political of individual countries and humanity in general. However, ICT development is fraught with new challenges and threats to international and national security. Interstate rivalry in the information sphere generates conflicts, an extreme form of which is an information war. Since 1998, the Russian initiative supports the international cooperation on information security at the global and regional level as well as within the framework of the bilateral relations. The article analyzes the characteristics of the global information society, which has a decisive influence on the international security in the information age, as well as international cooperation in this field. The analysis of Russian foreign policy initiatives in the field of international information security is also presented. Today more than 130 countries develop cyber capabilities, both defensive and offensive, that pose serious threats to the international stability. It's difficult to trace the source of information attacks and its consequences can be devastating and cause retaliation, including the use of conventional weapons. In this situation Russian approach, advocating for the development of the rules of conduct of States and demilitarization of information space in order to ensure its safety, seems urgent and relevant with the international situation.

  19. H.E. Mr Leonid A. Skotnikov, Ambassador, Permanent Representative of the Russian Federation to the United Nations and other International Organisations in Geneva

    CERN Multimedia

    Patrice Loïez

    2003-01-01

    H.E. Mr Leonid A. Skotnikov, Ambassador of the Russian Federation to the United Nations and other International Organisations in Geneva (far right). On his right F. Grishaev, Adviser, Mission of the Russian Federation; opposite N. Koulberg and L. Maiani, CERN Director general

  20. Note to the Secretariat from the Permanent Mission of the Czech and Slovak Federal Republic to the International Organizations in Vienna

    International Nuclear Information System (INIS)

    1993-01-01

    The document reproduces the Note received by the Director General from the Permanent Mission of the Czech and Slovak Federal Republic to the International Organizations in Vienna in connection with the dissolution of the CSFR on 31 December 1992

  1. Pharmaceutical Research Strategies

    OpenAIRE

    Phlippen, Sandra; Vermeersch, Ad

    2008-01-01

    textabstractThis study analyses 1400 research projects of the top 20 R&D-spending pharmaceuticals to identify the determinants of successful research projects. We provide clear evidence that externally sourced projects and projects involving biotechnologies perform better than internal projects and chemical projects, respectively. Controlling for these effects, we find that big pharma should either build a critical mass of disease area knowledge or diversify projects over different DA’s in or...

  2. H.E. Mr Leonid A. Skotnikov, Ambassador, Permanent Representative of the Russian Federation to the United Nations and other International Organisations in Geneva

    CERN Multimedia

    Maximilien Brice

    2003-01-01

    Photo 01: H.E. Mr Leonid A. Skotnikov, Ambassador of the Russian Federation to the United Nations and other International Organisations in Geneva (centre) with (from left to right) V. Kaftanov, Ph. Bloch, N. Koulberg, F. Grishaev Photo 02: H.E. Mr Leonid A. Skotnikov, Ambassador of the Russian Federation to the United Nations and other International Organisations in Geneva (centre) with Ph. Bloch (behind the Ambassador, V. Kaftanov) visiting the crystal laboratory in building 27.

  3. 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...

  4. International Uranium Resources Evaluation Project (IUREP) national favourability studies: Federal Republic of Germany

    International Nuclear Information System (INIS)

    1977-10-01

    The Federal Republic of Germany is situated in Central Europe. It covers an area of 250,000 square kilometres and has a population of 60 millions. The Federal Republic consists of 10 individual states. The capital of the country is Bonn. The northern and northwestern parts of the country are formed of flat lowlands, the Norddeutsche Tiefebene. Towards the south follow hilly and mountainous regions with elevations not exceeding 1000 m. In the southwestern and southeastern regions the elevations may reach 1500m in the Black Forest and Bayerischer Wald. The foreland of the Alps and the northern part of the Alps itself with elevations close to 3000 m make up the southern part of the Federal Republic. The main rivers - Rhine, Weser and Elbe - are directed towards northwest and drain the country to the North Sea. Only the southern part is drained by the southeast running river Danube. The climate is moderate, generally with frequent snow during the winter season and warm periods during the summer. The precipitation is distributed uniformly throughout the year. Due to the high industrialization a dense network of railroads, highways and motorroads exists.According to what is geologically known about the country, the chances for the discovery of large quantities of low-coast uranium resources must be considered to be limited. The potential for new discoveries of those deposits can be estimated to be around 10 000 t U. The potential for very low-grade uranium ore, such as granites, low-grade sedimentary rocks (sandstones, shales) can be estimated to range between 10,000 - 50,000 t U or possibly more taking into account very low-grade concentrations in shales. This material is not mineable under present conditions. Environmental considerations may prevent mining in the future

  5. 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.

  6. The problems of international transport corridors development on the territory of the Russian Federation

    Directory of Open Access Journals (Sweden)

    Rustamzade M.N.

    2017-03-01

    Full Text Available in the transition of the leading countries of the world on an innovative way of development, transport is considered as one of the most important factors of socio-economic growth in Russia. Transport contributes to strengthening the unity of the economic area of the country, improves the interregional and international transport and economic relations, increases the efficient using of natural resources, develops entrepreneurship and international cooperation. However, there is a number of obstacles before implementation of transport and transit potential of Russia. The paper deals with features of international and national transport corridors on the territory of Russia and the key problems of their functioning and possible ways to overcome them.

  7. Exploring democracy in the Russian Federation: political regime, public opinion and international assistance

    NARCIS (Netherlands)

    Gerrits, A.W.M.

    2010-01-01

    This article discusses three questions: what is the purpose of ‘democratic’ institutions and practices in Russia's authoritarian political system; how do these institutions and practices resonate with Russian public opinion; and how do they relate to the international democracy-promotion effort in

  8. Quantitative analysis of active compounds in pharmaceutical preparations by use of attenuated total-reflection Fourier transform mid-infrared spectrophotometry and the internal standard method.

    Science.gov (United States)

    Sastre Toraño, J; van Hattum, S H

    2001-10-01

    A new method is presented for the quantitative analysis of compounds in pharmaceutical preparations Fourier transform (FT) mid-infrared (MIR) spectroscopy with an attenuated total reflection (ATR) module. Reduction of the quantity of overlapping absorption bands, by interaction of the compound of interest with an appropriate solvent, and the employment of an internal standard (IS), makes MIR suitable for quantitative analysis. Vigabatrin, as active compound in vigabatrin 100-mg capsules, was used as a model compound for the development of the method. Vigabatrin was extracted from the capsule content with water after addition of a sodium thiosulfate IS solution. The extract was concentrated by volume reduction and applied to the FTMIR-ATR module. Concentrations of unknown samples were calculated from the ratio of the vigabatrin band area (1321-1610 cm(-1)) and the IS band area (883-1215 cm(-1)) using a calibration standard. The ratio of the area of the vigabatrin peak to that of the IS was linear with the concentration in the range of interest (90-110 mg, in twofold; n=2). The accuracy of the method in this range was 99.7-100.5% (n=5) with a variability of 0.4-1.3% (n=5). The comparison of the presented method with an HPLC assay showed similar results; the analysis of five vigabatrin 100-mg capsules resulted in a mean concentration of 102 mg with a variation of 2% with both methods.

  9. Pharmaceutical interventions by collaboration between staff pharmacists and clinical pharmacists and implementation of Joint Commission International Accreditation Standards on medication use may optimize pharmacotherapy in geriatric patients

    Directory of Open Access Journals (Sweden)

    Chen M

    2016-11-01

    Full Text Available Meng Chen, Quan Zhou Department of Pharmacy, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, People’s Republic of ChinaWe read with great interest the prospective study by Cortejoso et al,1 which describes the characteristics of pharmaceutical interventions in two geriatric wards (orthogeriatric ward and geriatric day unit of a general teaching hospital. We strongly agree with their finding that shows the importance of clinical pharmacist involvement in the optimization of pharmacotherapy in elderly patients. Furthermore, we especially appreciate their new and interesting findings that the clinical pharmacist was more frequently requested by physicians and nurses for information about the pharmacotherapy of the patients on the geriatric day unit, compared with the orthogeriatric ward at admission and discharge (5.7% vs 1.2% and 1.7%, respectively, P<0.05, and that the pharmacist asked for more confirmation of the physician orders on the geriatric day unit rather than the orthogeriatric ward (19.8% vs 1.8% and 15.7% at admission and discharge, respectively, P<0.05. We are from a Joint Commission International (JCI-accredited academic medical center hospital with 3200 beds in China. Safe medication management and use are pivotal to patient safety and quality of care on which the state-of-the-art standards of the Joint Commission focus. We would like to share our perspectives in the following paragraphs.View original paper by Cortejoso and colleagues. 

  10. Asia Federation Report on International Symposium on Grid Computing (ISGC) 2010

    Science.gov (United States)

    Grey, Francois; Lin, Simon C.

    This report provides an overview of developments in the Asia-Pacific region, based on presentations made at the International Symposium on Grid Computing 2010 (ISGC 2010), held 5-12 March at Academia Sinica, Taipei. The document includes a brief overview of the EUAsiaGrid project as well as progress reports by representatives of 13 Asian countries presented at ISGC 2010. In alphabetical order, these are: Australia, China, India, Indonesia, Japan, Malaysia, Pakistan, Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam.

  11. Asia Federation Report on International Symposium on Grid Computing 2009 (ISGC 2009)

    Science.gov (United States)

    Grey, Francois

    This report provides an overview of developments in the Asia-Pacific region, based on presentations made at the International Symposium on Grid Computing 2009 (ISGC 09), held 21-23 April. This document contains 14 sections, including a progress report on general Asia-EU Grid activities as well as progress reports by representatives of 13 Asian countries presented at ISGC 09. In alphabetical order, these are: Australia, China, India, Indonesia, Japan, Malaysia, Pakistan, Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam.

  12. The pharmaceutical quality revolution

    Directory of Open Access Journals (Sweden)

    Jordi Botet

    2016-01-01

    Full Text Available Pharmaceutical products are patient-oriented. If they had a deficient quality they might put live at risk. Ensuring their quality is not, however, a straightforward task and this is why different approaches have been used along the way. This article analyzes them and shows how our present approach, if well implemented, is very effective in ensuring quality.Methods. This article analyzes the current pharmaceutical quality system as described by international guidances in the light of practical experience gathered by the author as an international GMP-consultant.Result. Nowadays we have come to understand that as quality is a global concept in terms of time and of requirements, it has to be assured in a global way too. This is why quality assurance is a permanent process that starts during the development of a product and goes on during its manufacturing life. Manufacturing should be performed within a pharmaceutical quality system which ensures GMP compliance. Decisions should be science and risk-based. Products and processes are monitored by means of critical variables.Conclusions. The approach followed in the 21st century for ensuring quality is very effective and allows for a progressive reduction of the level of quality risk. However, this quality system is either comprehensive or there is no quality

  13. The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961-1990).

    Science.gov (United States)

    Erices, Rainer; Frewer, Andreas; Gumz, Antje

    2018-01-01

    After the building of the Berlin Wall in the 1960s, a number of international pharmaceutical manufacturers from the West had their drugs tested in Eastern Germany (GDR). So far, the extensive collection of documents on the subject stored in the archives of the GDR State Security Service (Stasi, MfS) has not been systematically analysed. Until now, the role of the Stasi with respect to the surveillance of the trials has been unclear. A keyword search within the database of the Stasi files was conducted. All available files were screened in order to identify institutions, companies and personnel involved in the clinical trials. On this basis, further files were requested. A total of 259 files were available for analysis. Relevant data was derived from 160 of these files. A contextualised approach was applied, which critically explored the origin, content, and impact of the data. In addition, an approach guided by the central steps of document analysis was applied. At least 400 clinical trials were conducted during the GDR period. The exact number remains speculative. According to references found in the Stasi files, it might have been considerably higher. Initially, the main goal of the trials was for the GDR authorities to decide whether to import certain Western drugs. By 1983, this intention had changed. Now, the primary aim of the trials was the procurement of foreign currency. The Stasi feared that the pharmaceutical companies could have a significant influence on GDR Health System. Stasi spies were holding positions in the responsible medical committees, universities, and hospitals. Constant surveillance by the Stasi served the purpose of monitoring any contact between people from the West and the East. Unknowingly, representatives of Western companies were surveilled by the Stasi. The studied documents also point to the fact that a number of clinical trials conducted during the GDR period did not comply with GDR regulations, and were therefore deemed illegal

  14. [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.

  15. 75 FR 33824 - Pharmaceutical Products and Chemical Intermediates, Fourth Review: Advice Concerning the Addition...

    Science.gov (United States)

    2010-06-15

    ... INTERNATIONAL TRADE COMMISSION [Investigation No. 332-520] Pharmaceutical Products and Chemical Intermediates, Fourth Review: Advice Concerning the Addition of Certain Products to the Pharmaceutical Appendix..., Pharmaceutical Products and Chemical Intermediates, Fourth Review: Advice Concerning the Addition of Certain...

  16. 75 FR 54232 - Proposed Collection; Comment Request for Report of Covered Pharmaceutical Manufacturers and...

    Science.gov (United States)

    2010-09-03

    ... Report of Covered Pharmaceutical Manufacturers and Importers (Form-8947) AGENCY: Internal Revenue Service...)). Currently, the IRS is soliciting comments concerning Form-8947, Report of Covered Pharmaceutical...: Title: Report of Covered Pharmaceutical Manufacturers and Importers. OMB Number: 1545-XXXX. Form Number...

  17. Diagnostic value of the 2011 International Federation for Cervical Pathology and Colposcopy Terminology in predicting cervical lesions

    Science.gov (United States)

    Zhang, Liqin; Yan, Ye; Han, Cha; Xue, Fengxia

    2018-01-01

    Objective To evaluate the diagnostic accuracy of the 2011 International Federation for Cervical Pathology and Colposcopy (IFCPC) colposcopic terminology. Methods The clinicopathological data of 2262 patients who underwent colposcopy from September 2012 to September 2016 were reviewed. The colposcopic findings, colposcopic impression, and cervical histopathology of the patients were analyzed. Correlations between variables were evaluated using cervical histopathology as the gold standard. Results Colposcopic diagnosis matched biopsy histopathology in 1482 patients (65.5%), and the weighted kappa strength of agreement was 0.480 (Pterminology can improve the diagnostic accuracy for all lesion severities. The categorization of major changes and minor changes is appropriate. However, colposcopic diagnosis remains unsatisfactory. Poor reproducibility of type 2 transformation zone and the significance of leukoplakia require further study. PMID:29507681

  18. Health promotion through sport: international sport federations' priorities, actions and opportunities.

    Science.gov (United States)

    Mountjoy, Margo; Costa, A; Budgett, R; Dvorak, J; Engebretsen, L; Miller, S; Moran, J; Foster, J; Carr, J

    2018-01-01

    To identify areas of priority and activity for international sportsfederations (IFs) with respect to athlete health and safety, and global health. Results serve to direct the work of the Association of Summer Olympic IF Medical and Scientific Consultative Group, the International Olympic Committee and to influence IFs' planning and priorities. The 28 IFs participating in the Summer Olympic Games (2016) were asked to rank the relative importance of 11 health-related topics and to report their activities or research initiatives on 27 identified topics using an electronic survey. A comparison with a similar survey (2012) was made. The response rate was 100%. In general, the ' fight against doping ' had the highest priority followed by 'image as a safe sport '. The topics with the lowest importance ratings were ' increasing the number of elite athletes ', and ' health of the general population '. Despite ranking ' health of your athletes ,' as a top priority, IFs are not addressing all aspects of athlete health. In comparison with 2012, there was a significant decrease in priority for IFs is ' health of the general population '. Despite the widespread knowledge of the importance of the promotion of physical activity (sport) on global health, the decreasing priority and programming of the IFs on physical activity promotion is concerning. Although IFs have prioritised the protection of the health of elite athletes, there are gaps in programming demonstrating that IFs are missing important areas of athlete health. Improving recreational athlete health programming could also benefit population health as well as improve IF fan base and sport participation. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. Core competencies for pharmaceutical physicians and drug development scientists

    Science.gov (United States)

    Silva, Honorio; Stonier, Peter; Buhler, Fritz; Deslypere, Jean-Paul; Criscuolo, Domenico; Nell, Gerfried; Massud, Joao; Geary, Stewart; Schenk, Johanna; Kerpel-Fronius, Sandor; Koski, Greg; Clemens, Norbert; Klingmann, Ingrid; Kesselring, Gustavo; van Olden, Rudolf; Dubois, Dominique

    2013-01-01

    Professional groups, such as IFAPP (International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine), are expected to produce the defined core competencies to orient the discipline and the academic programs for the development of future competent professionals and to advance the profession. On the other hand, PharmaTrain, an Innovative Medicines Initiative project, has become the largest public-private partnership in biomedicine in the European Continent and aims to provide postgraduate courses that are designed to meet the needs of professionals working in medicines development. A working group was formed within IFAPP including representatives from PharmaTrain, academic institutions and national member associations, with special interest and experience on Quality Improvement through education. The objectives were: to define a set of core competencies for pharmaceutical physicians and drug development scientists, to be summarized in a Statement of Competence and to benchmark and align these identified core competencies with the Learning Outcomes (LO) of the PharmaTrain Base Course. The objectives were successfully achieved. Seven domains and 60 core competencies were identified and aligned accordingly. The effective implementation of training programs using the competencies or the PharmaTrain LO anywhere in the world may transform the drug development process to an efficient and integrated process for better and safer medicines. The PharmaTrain Base Course might provide the cognitive framework to achieve the desired Statement of Competence for Pharmaceutical Physicians and Drug Development Scientists worldwide. PMID:23986704

  20. Core Competencies for Pharmaceutical Physicians and Drug Development Scientists

    Directory of Open Access Journals (Sweden)

    Honorio eSilva

    2013-08-01

    Full Text Available Professional groups, such as IFAPP (International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine, are expected to produce the defined core competencies to orient the discipline and the academic programs for the development of future competent professionals and to advance the profession. On the other hand, PharmaTrain, an Innovative Medicines Initiative project, has become the largest public-private partnership in biomedicine in the European Continent and aims to provide postgraduate courses that are designed to meet the needs of professionals working in medicines development. A working group was formed within IFAPP including representatives from PharmaTrain, academic institutions and national member associations, with special interest and experience on Quality Improvement through education. The objectives were: to define a set of core competencies for pharmaceutical physicians and drug development scientists, to be summarized in a Statement of Competence and to benchmark and align these identified core competencies with the Learning Outcomes of the PharmaTrain Base Course. The objectives were successfully achieved. Seven domains and 60 core competencies were identified and aligned accordingly. The effective implementation of training programs using the competencies or the PharmaTrain Learning Outcomes anywhere in the world may transform the drug development process to an efficient and integrated process for better and safer medicines. The PharmaTrain Base Course might provide the cognitive framework to achieve the desired Statement of Competence for Pharmaceutical Physicians and Drug Development Scientists worldwide.

  1. Analysis of cocaine and its adulterants in drugs for international trafficking seized by the Brazilian Federal Police.

    Science.gov (United States)

    Lapachinske, Silvio Fernandes; Okai, Guilherme Gonçalves; dos Santos, Ariana; de Bairros, André Valle; Yonamine, Mauricio

    2015-02-01

    Here, gas chromatography with nitrogen phosphorous detector (GC-NPD) method was developed and validated for the quantification of cocaine and adulterants (caffeine, 4-dimethylaminoantipyrine, levamisole, lidocaine and phenacetin) in illicit samples. The method was based on direct dilution of samples in methanol, sonication for 5 min and centrifugation. After appropriate dilution, an aliquot was injected into GC-MS in order to identify the active compounds and into GC-NPD for the analytes quantification. Bupivacaine was used as an internal standard. The method showed to be precise, accurate and linear over a range of 0.5-100% (weight/weight percentages) for all analytes, except phenacetin which showed a linear range between 2% and 100%. The method was successfully applied to 54 samples seized by the Brazilian Federal Police in the International Airport of Sao Paulo and mailing services during the year 2011. All the samples were associated with international trafficking and were apprehended while leaving the country. The purity of cocaine ranged from 16.5% to 91.4%. Cocaine was the only detected active compound in 29.6% of total samples. Among the identified cutting agents, levamisole was the most abundant (55.6% of the total samples) and relative concentrations (weight/weight percentages) ranged from 0.7% to 23%. Lidocaine, caffeine, phenacetin and 4-dimethylaminoantipyrine were also identified in these samples in minor concentrations. In contrast with what we initially hypothesized, drugs intended to international trafficking did not present high cocaine purity and most of the samples were laced with adulterants before leaving Brazil. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  2. 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...

  3. 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).

  4. 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...

  5. 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

  6. Discriminating Between Legitimate and Predatory Open Access Journals: Report from the International Federation for Emergency Medicine Research Committee

    Directory of Open Access Journals (Sweden)

    Bhakti Hansoti

    2016-09-01

    Full Text Available Introduction: Open access (OA medical publishing is growing rapidly. While subscription-based publishing does not charge the author, OA does. This opens the door for “predatory” publishers who take authors’ money but provide no substantial peer review or indexing to truly disseminate research findings. Discriminating between predatory and legitimate OA publishers is difficult. Methods: We searched a number of library indexing databases that were available to us through the University of California, Irvine Libraries for journals in the field of emergency medicine (EM. Using criteria from Jeffrey Beall, University of Colorado librarian and an expert on predatory publishing, and the Research Committee of the International Federation for EM, we categorized EM journals as legitimate or likely predatory. Results: We identified 150 journal titles related to EM from all sources, 55 of which met our criteria for OA (37%, the rest subscription based. Of these 55, 25 (45% were likely to be predatory. We present lists of clearly legitimate OA journals, and, conversely, likely predatory ones. We present criteria a researcher can use to discriminate between the two. We present the indexing profiles of legitimate EM OA journals, to inform the researcher about degree of dissemination of research findings by journal. Conclusion: OA journals are proliferating rapidly. About half in EM are legitimate. The rest take substantial money from unsuspecting, usually junior, researchers and provide no value for true dissemination of findings. Researchers should be educated and aware of scam journals.

  7. Federal Administrative Court denies the International Union for the Protection of Life the right to file suit

    International Nuclear Information System (INIS)

    Anon.

    1980-01-01

    In its decision of July 16, 1980, the Federal Administrative Court dismissed the appeal lodged by the International Union for the Protection of Life against the dismissal by the Supreme Administrative Court concerning the action to set aside the preliminary decision on the Kruemmel reactor. The Court denied its right to file suit. The amount in ligitation was fixed at 20000 DM. The appelant cannot assert that his rights are being violated. The appelent's commitment to protect life is not hindered in an administrative way by the preliminary decision. Only members of the association could put forward that the basic rights of the individual protected in Art. 2, Sect. 2 of the Basic Law are being endangered. Section 7 (2) of the Atomic Energy Law does not serve to protect the freedom of association, it gives third party protection for associations only in case of property damage. Neither can the right to file suit be derived for the addressee of a decision from Section 4 (2) of the Ordinance concerning the procedure for licensing nuclear installations. (HSCH) [de

  8. Prevalence of the metabolic syndrome among North Indian adolescents using Adult Treatment Panel III and pediatric International Diabetic Federation definitions

    Directory of Open Access Journals (Sweden)

    Riyaz Ahmad Bhat

    2015-01-01

    Full Text Available Background and Objective: Childhood obesity is an important risk factor for the development of metabolic syndrome (MS in children and adolescent. Because of high prevalence of insulin resistance and MS in Indian adult population, studies are needed to identify the prevalence of these metabolic abnormalities in the adolescent population. The objective of this study was to estimate the prevalence of MS using pediatric International Diabetic Federation (IDF definition and compare it with estimates of Adult Treatment Panel III (ATP III definition among adolescents in Northern India. Materials and Methods: At a total of 899 adolescents attending school (aged 10-18 years participated in this population-based prospective study. All the clinical and biochemical assessment were done after proper consent. The MS was determined by the National Cholesterol Education Program ATP III definition modified for age and pediatric IDF definition. Results: The prevalence of MS was 3.5% according to ATP III criteria and 1.5% based on IDF criteria. No significant gender difference was observed in the distribution of MS. Hypertriglyceridemia was the most common and abdominal obesity the least common constituent of MS. Conclusion: This study provides the first estimates of MS using pediatric IDF definition in the adolescent population from Northern India.

  9. Communication received from the Federal Minister for European and International Affairs of Austria with regard to the Austrian proposal on the multilateralization of the nuclear fuel cycle

    International Nuclear Information System (INIS)

    2007-01-01

    The Agency has received a communication dated 10 May 2007 from the Federal Minister for European and International Affairs of the Republic of Austria, attaching a paper on the Multilateralization of the Nuclear Fuel Cycle. As requested in that communication, the paper is herewith circulated for the information of Member States

  10. Communication received from the Resident Representative of the Russian Federation to the IAEA on the establishment, structure and operation of the International Uranium Enrichment Centre

    International Nuclear Information System (INIS)

    2007-01-01

    The Director General has received a communication dated 7 June 2007 from the Resident Representative of the Russian Federation, with an attachment entitled 'Establishment, Structure and Operation of the International Uranium Enrichment Centre'. As requested in that communication, the letter and its attachment are circulated for the information of Member States

  11. Tropical Journal of Pharmaceutical Research: Submissions

    African Journals Online (AJOL)

    The Tropical Journal of Pharmaceutical Research is an international Open Access ... drug events, medical and other life sciences, and related engineering fields). ... Studies on synthesis of new compounds should only be considered if they ...

  12. Pharmaceutical Care Implementation: A Survey of Attitude ...

    African Journals Online (AJOL)

    International Journal of Health Research ... Purpose: To assess the attitude, perception and practice of pharmacists in Ogun State towards pharmaceutical care implementation. Methods: Pre-tested and validated structured questionnaire was ...

  13. Protocol between the Russian Federation and the International Atomic Energy Agency Additional to the Agreement between the Union of Soviet Socialist Republics and the International Atomic Energy Agency for the Application of Safeguards in the Union of Soviet Socialist Republics

    International Nuclear Information System (INIS)

    2008-01-01

    The text of the Protocol between the Russian Federation and the International Atomic Energy Agency Additional to the Agreement between the Union of Soviet Socialist Republics and the International Atomic Energy Agency for the Application of Safeguards in the Union of Soviet Socialist Republics is reproduced in this document for the information of all Members. The Board of Governors approved the Protocol on 21 March 2000. It was signed on 22 March 2000 in Vienna. Pursuant to Article 11 of the Additional Protocol, the Protocol entered into force on 16 October 2007, the date on which the Agency received from the Russian Federation written notification that the procedures of the Russian Federation required for entry into force had been met

  14. Protocol between the Russian Federation and the International Atomic Energy Agency Additional to the Agreement between the Union of Soviet Socialist Republics and the International Atomic Energy Agency for the Application of Safeguards in the Union of Soviet Socialist Republics

    International Nuclear Information System (INIS)

    2008-01-01

    The text of the Protocol between the Russian Federation and the International Atomic Energy Agency Additional to the Agreement between the Union of Soviet Socialist Republics and the International Atomic Energy Agency for the Application of Safeguards in the Union of Soviet Socialist Republics is reproduced in this document for the information of all Members. The Board of Governors approved the Protocol on 21 March 2000. It was signed on 22 March 2000 in Vienna. Pursuant to Article 11 of the Additional Protocol, the Protocol entered into force on 16 October 2007, the date on which the Agency received from the Russian Federation written notification that the procedures of the Russian Federation required for entry into force had been met [es

  15. Pricing and Reimbursement in U.S. Pharmaceutical Markets

    OpenAIRE

    Newhouse, Joseph Paul; Berndt, Ernst R.

    2010-01-01

    In this survey chapter on pricing and reimbursement in U.S. pharmaceutical markets, we first provide background information on important federal legislation, institutional details regarding distribution channel logistics, definitions of alternative price measures, related historical developments, and reasons why price discrimination is highly prevalent among branded pharmaceuticals. We then present a theoretical framework for the pricing of branded pharmaceuticals, without and then in the pre...

  16. Public Participation and the Rights of the Child: Reflection on International Law Standards in the Legal System of the Russian Federation

    Directory of Open Access Journals (Sweden)

    Mariya Riekkinen

    2016-01-01

    Full Text Available This article deals with the much debated issue of children’s public participation from the perspective of legal practices in the Russian Federation. Having emerged at the level of national jurisdictions, the practice of engaging minors in decision-making processes on issues of public significance – or the practice of public participation of children – is stipulated by the UN Committee on the Rights of the Child, based on Article 12 of the UN Convention on the Rights of the Child. Public participation of minors implies that children have clearly defined opportunities to take part in decision-making processes concerning those political and public matters affecting their interests.Albeit limited by the clause “regarding the issues concerning them,” the claims for such participation are dictated by emerging standards of international law. The author has examined the process of devising these standards in Russian public law. Moreover, an analysis of the evolution of academic views on public participation of children in Russian legal scholarship is also included in this article.Relying extensively on the method of legal analysis and the comparative analysis of the conformity of national public law standards with respect to international law, the author proposes several legal amendments to the Federal law “On the Basic Guarantees of the Rights of the Child in the Russian Federation,” which would lead to anchoring more solidly the participatory right of minors in the legal system of the Russian Federation.

  17. 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

  18. Developing emergency medical dispatch systems in Africa – Recommendations of the African Federation for Emergency Medicine/International Academies of Emergency Dispatch Working Group

    Directory of Open Access Journals (Sweden)

    Nee-Kofi Mould-Millman

    2015-09-01

    To facilitate the development of EMD systems appropriate for the African setting, the African Federation for Emergency Medicine (AFEM and the International Academies of Emergency Dispatch (IAED convened a working group in November 2014 to provide conceptual, technical, and innovative recommendations for contextually appropriate EMD systems for African settings. It is hoped that these recommendations will augment efficiency, effectiveness, and standardisation within and among African EMD systems, thereby improving health outcomes for sufferers of acute illness or injury.

  19. External and internal accidents in PWR power plants. Comparison of current regulations in Belgium, United States, France, Federal Republic of Germany and United Kingdom

    International Nuclear Information System (INIS)

    Maere, G. de; Roch, M.; Cavaco, A.; Preat, M.

    1986-01-01

    In this report a comparison is made of the rules and practices applied in various countries (Belgium, France, Federal Republic of Germany, United Kingdom and United States of America) in designing PWR plants to resist natural hazards (first part of the report) and hazards associated with human activities (second part). The third part of the report deals with the practices in different countries concerning the protection against accidents of internal origin [fr

  20. Integrating systems approaches into pharmaceutical sciences.

    NARCIS (Netherlands)

    Westerhoff, H.V.; Mosekilde, E.; Noe, C.; Clemensen, A.M.

    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

  1. Supervision of nuclear material in the Federal Republic of Germany by the Commission of the European Communities (Euratom) and the International Atomic Energy Organisation (IAEO)

    International Nuclear Information System (INIS)

    Brueckner, C.

    1979-01-01

    Since the fifties Euratom has controlled nuclear material in the Federal Republic of Germany. When the verification agreement came into force in the treaty on the non-proliferation of atomic weapons in February 1977, the International Atomic Energy Organisation (IAEO) has commenced the supervision of nuclear material in German nuclear energy installations. The author describes the basic principle of the supervision and the possible effects on the installations. In addition, he also deals with the discussions which have flared up about the international supervision of nuclear material, and indicates possible future developments. (orig.) [de

  2. Agreements concluded by the Federal Republic of Germany under international law in the field of environmental protection. Annex: Treaties with the GDR. (Source index in the Federal Law Gazette, part II). (As of September 15, 1987)

    International Nuclear Information System (INIS)

    Lohse, S.

    1987-01-01

    This compilation contains all agreements under international law in the field of environmental protection, the FRG has joined and that have been published and/or announced in the Federal Law Gazette, part II. The summary is of September 15, 1987. The classification is made according to the subjects: waste management law, pollution abatement law, nuclear law and energy and mining law and within these according to the date of treaty/agreement. For easier access, there are a chronological index, an index of the contracting states and an index of the places of contract. In the annex the relevant treaties with the German Democratic Republic are indicated. (orig./HP) [de

  3. Financing pharmaceuticals in transition economies.

    Science.gov (United States)

    Kanavos, P

    1999-06-01

    This paper (a) provides a methodological taxonomy of pricing, financing, reimbursement, and cost containment methodologies for pharmaceuticals; (b) analyzes complex agency relationships and the health versus industrial policy tradeoff; (c) pinpoints financing measures to balance safety and effectiveness of medicines and their affordability by publicly funded systems in transition; and (d) highlights viable options for policy-makers for the financing of pharmaceuticals in transition. Three categories of measures and their implications for pharmaceutical policy cost containing are analyzed: supply-side measures, targeting manufacturers, proxy demand-side measures, targeting physicians and pharmacists, and demand-side measures, targeting patients. In pursuing supply side measures, we explore free pricing for pharmaceuticals, direct price controls, cost-plus and cost pricing, average pricing and international price comparisons, profit control, reference pricing, the introduction of a fourth hurdle, positive and negative lists, and other price control measures. The analysis of proxy-demand measures includes budgets for physicians, generic policies, practice guidelines, monitoring the authorizing behavior of physicians, and disease management schemes. Demand-side measures explore the effectiveness of patient co-payments, the impact of allowing products over-the-counter and health promotion programs. Global policies should operate simultaneously on the supply, the proxy demand, and the demand-side. Policy-making needs to have a continuous long-term planning. The importation of policies into transition economy may require extensive and expensive adaptation, and/or lead to sub-optimal policy outcomes.

  4. 77 FR 75672 - Manufacturer of Controlled Substances, Notice of Registration, Halo Pharmaceutical, Inc.

    Science.gov (United States)

    2012-12-21

    ..., Notice of Registration, Halo Pharmaceutical, Inc. By Notice dated July 30, 2012, and published in the Federal Register on August 7, 2012, 77 FR 47114, Halo Pharmaceutical, Inc., 30 North Jefferson Road... 21 U.S.C. 823(a), and determined that the registration of Halo Pharmaceutical, Inc., to manufacture...

  5. 78 FR 33441 - Importer of Controlled Substances; Notice of Registration; Caraco Pharmaceutical Laboratories, LTD

    Science.gov (United States)

    2013-06-04

    ... Registration; Caraco Pharmaceutical Laboratories, LTD By Notice dated February 8, 2013, and published in the Federal Register on February 21, 2013, 78 FR 12101, Caraco Pharmaceutical Laboratories, Ltd., 270 Prospect... 952(a), and determined that the registration of Caraco Pharmaceutical Laboratories, Ltd., to import...

  6. 77 FR 16264 - Manufacturer of Controlled Substances, Notice of Registration; Halo Pharmaceutical Inc.

    Science.gov (United States)

    2012-03-20

    ..., Notice of Registration; Halo Pharmaceutical Inc. By Notice dated December 2, 2011, and published in the Federal Register on December 14, 2011, 76 FR 77850, Halo Pharmaceutical Inc., 30 North Jefferson Road... considered the factors in 21 U.S.C. 823(a) and determined that the registration of Halo Pharmaceutical Inc...

  7. 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...

  8. 78 FR 46373 - Manufacturer of Controlled Substances; Notice of Registration; Johnson Matthey Pharmaceutical...

    Science.gov (United States)

    2013-07-31

    ...; Notice of Registration; Johnson Matthey Pharmaceutical Materials, Inc. By Notice dated March 20, 2013, and published in the Federal Register on March 28, 2013, 78 FR 19017, Johnson Matthey Pharmaceutical Materials, Inc., Pharmaceutical Services, 25 Patton Road, Devens, Massachusetts 01434, made application by...

  9. 78 FR 12104 - Manufacturer of Controlled Substances; Notice of Registration; INB Hauser Pharmaceutical Services...

    Science.gov (United States)

    2013-02-21

    ...; Notice of Registration; INB Hauser Pharmaceutical Services, Inc. By Notice dated November 1, 2012, and published in the Federal Register on November 9, 2012, 77 FR 67398, InB Hauser Pharmaceutical Services, Inc... Hauser Pharmaceutical Services, Inc., to manufacture the listed basic class of controlled substance is...

  10. Communication of 22 May 1998 received from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency

    International Nuclear Information System (INIS)

    1998-01-01

    The document reproduces the text of a communication dated 22 May 1998 received at the IAEA from the Permanent Mission of the Russian Federation to the IAEA, including a statement from the Ministry of Foreign Affairs of Russia and a communication for publication, regarding the tests of nuclear weapons conducted by India on 11 May 1998

  11. Communication of 29 May 1998 received from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency

    International Nuclear Information System (INIS)

    1998-01-01

    The document reproduces the text of a communication dated 29 May 1998 received at the IAEA from the Permanent Mission of the Russian Federation to the IAEA, including a statement from the Ministry of Foreign Affairs of Russia regarding the tests of nuclear devices conducted by Pakistan on 28 May 1998

  12. Elaboration of the international transfer mechanism of reduction in greenhouse gas emissions on the basis of the Russian federal law About agreements of products sharing'

    International Nuclear Information System (INIS)

    Toivonen, N.R.; Koulikovskaya, L.

    2001-01-01

    Suggestions for a comprehensive legal framework for the implementation in Russia of the flexibility mechanisms established under the Kyoto Protocol (i.e. joint implementation; clean development mechanism; international emissions trading) are proposed. It is suggested that the legal framework be established using the principles embodied in the existing Russian federal law, 'About agreements of product sharing' adopted in 1995. As a basic requirement, it is suggested that the new federal law must include the fundamental elements required to create possibilities for the Russian Federation to participate in the process of certified emission reductions (CER) transfer, emissions reduction unit (ERU) negotiation, and adjusted amount units (AAU) trading within the framework of the Kyoto Protocol implementation. The new law must also embody the basic procedures required to enter into agreements at the international, inter-regional and inter-sectoral levels. Failure to develop the legislative support and the legal framework to facilitate valid Russian participation in the implementation of the Kyoto Protocol will prevent many valuable initiatives and projects from being realized

  13. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity.

    Science.gov (United States)

    Alberti, K G M M; Eckel, Robert H; Grundy, Scott M; Zimmet, Paul Z; Cleeman, James I; Donato, Karen A; Fruchart, Jean-Charles; James, W Philip T; Loria, Catherine M; Smith, Sidney C

    2009-10-20

    A cluster of risk factors for cardiovascular disease and type 2 diabetes mellitus, which occur together more often than by chance alone, have become known as the metabolic syndrome. The risk factors include raised blood pressure, dyslipidemia (raised triglycerides and lowered high-density lipoprotein cholesterol), raised fasting glucose, and central obesity. Various diagnostic criteria have been proposed by different organizations over the past decade. Most recently, these have come from the International Diabetes Federation and the American Heart Association/National Heart, Lung, and Blood Institute. The main difference concerns the measure for central obesity, with this being an obligatory component in the International Diabetes Federation definition, lower than in the American Heart Association/National Heart, Lung, and Blood Institute criteria, and ethnic specific. The present article represents the outcome of a meeting between several major organizations in an attempt to unify criteria. It was agreed that there should not be an obligatory component, but that waist measurement would continue to be a useful preliminary screening tool. Three abnormal findings out of 5 would qualify a person for the metabolic syndrome. A single set of cut points would be used for all components except waist circumference, for which further work is required. In the interim, national or regional cut points for waist circumference can be used.

  14. 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.

  15. 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.

  16. Communication from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency regarding guidelines for transfers of nuclear-related dual-use equipment, materials, software and related technology

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-08-04

    The document reproduces the text of the Note Verbale received by the Director General of the IAEA from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency providing information on the export policies and practices of the Government of the Russian Federation with respect to the export of nuclear-related dual-use equipment, materials, software and related technology.

  17. Communication from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency regarding guidelines for transfers of nuclear-related dual-use equipment, materials, software and related technology

    International Nuclear Information System (INIS)

    2000-01-01

    The document reproduces the text of the Note Verbale received by the Director General of the IAEA from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency providing information on the export policies and practices of the Government of the Russian Federation with respect to the export of nuclear-related dual-use equipment, materials, software and related technology

  18. The implementation of internal assessment mechanisms in the management of the educational program: ESG principles and new educational standards in the Russian Federation

    Directory of Open Access Journals (Sweden)

    Nikanorov Ivan

    2018-01-01

    Full Text Available The purpose of this article is to describe possible approaches to transforming the management of the educational program into an educational institution of higher education in the context of implementing the principles laid down in the Standards and Recommendations for Quality Assurance in the European Higher Education Area (ESG, as well as the updated Russian state higher education standards (RSHES 3 ++. The article analyzes the ESG, examines the main models of managing educational programs, as well as their possible transformations in terms of the formation of mechanisms for internal assessment of the quality of educational activities and the training of students, introduced in the updated federal state educational standards.

  19. Aerial Photography and Imagery, Oblique, This data set was acquired through a federal grant with Pictometry International. The imagery is either 4" or 9" resolution., Published in 2011, Not Applicable scale, Chippewa County Government.

    Data.gov (United States)

    NSGIC Local Govt | GIS Inventory — Aerial Photography and Imagery, Oblique dataset current as of 2011. This data set was acquired through a federal grant with Pictometry International. The imagery is...

  20. His Excellency Mr Deepak Dhital Ambassador Extraordinary and Plenipotentiary Permanent Representative of the Federal Democratic Republic of Nepal to the United Nations Office and other international organisations in Geneva

    CERN Multimedia

    Bennett, Sophia Elizabeth

    2017-01-01

    His Excellency Mr Deepak Dhital Ambassador Extraordinary and Plenipotentiary Permanent Representative of the Federal Democratic Republic of Nepal to the United Nations Office and other international organisations in Geneva

  1. 11 June 2012 - Austrian Federal Minister of Labour, Social Affairs and Consumer Protection R. Hundstorfer signing the guest book with Head of International Relations F. Pauss and Ambassador to the UN C. Strohal (CERN-HI-120611334)

    CERN Multimedia

    2012-01-01

    11 June 2012 - Austrian Federal Minister of Labour, Social Affairs and Consumer Protection R. Hundstorfer signing the guest book with Head of International Relations F. Pauss and Ambassador to the UN C. Strohal (CERN-HI-120611334)

  2. Organizational administrative assurance of the movement of staff within the internal affairs bodies of the Russian Federation

    Directory of Open Access Journals (Sweden)

    Galina JURAVLIOVA

    2017-06-01

    Full Text Available The insufficiency of the scientific development of the organization and legal support of the staff rotation process within Internal Affairs bodies has determined the choice of the article topic.

  3. 76 FR 65210 - Certain Products and Pharmaceutical Compositions Containing Recombinant Human Erythropoetin...

    Science.gov (United States)

    2011-10-20

    ... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-568] Certain Products and Pharmaceutical Compositions Containing Recombinant Human Erythropoetin; Termination of Investigation on the Basis of... after importation of certain products and pharmaceutical compositions containing recombinant human...

  4. Pharmaceutical Pricing in Germany: How Is Value Determined within the Scope of AMNOG?

    Science.gov (United States)

    Lauenroth, Victoria Desirée; Stargardt, Tom

    To analyze how value is determined within the scope of the German Pharmaceutical Restructuring Act, which came into effect in 2011. Using data from all pharmaceuticals that had undergone assessment, appraisal, and price negotiations in Germany before June 30, 2016, we applied generalized linear model regression to analyze the impact of added benefit on the difference between negotiated prices and the prices of comparators. Data were extracted from the Federal Joint Committee's appraisals and price databases. We specified added benefit in various ways. In all models, we controlled for additional criteria such as size of patient population, European price levels, and whether the comparators were generic. Our regression results confirmed the descriptive results, with price premiums reflecting the extent of added benefit as appraised by the Federal Joint Committee. On the substance level, an added benefit was associated with an increase in price premium of 227.2% (P price premium of 377.5% (P price premium (624.3%; P Price premiums, or "value," are driven by health gain, the share of patients benefiting from a pharmaceutical, European price levels, and whether comparators are generic. No statement can be made, however, about the appropriateness of the level of price premiums. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  5. Gas reactor international cooperative program interim report: United States/Federal Republic of Germany nuclear licensing comparison

    International Nuclear Information System (INIS)

    1978-09-01

    In order to compare US and FRG Nuclear Licensing, a summary description of United States Nuclear Licensing is provided as a basis. This is followed by detailed information on the participants in the Nuclear Licensing process in the Federal Republic of Germany (FRG). FRG licensing procedures are described and the rules and regulations imposed are summarized. The status of gas reactor licensing in both the U.S. and the FRG is outlined and overall conclusions are drawn as to the major licensing differences. An appendix describes the most important technical differences between US and FRG criteria

  6. Radiosterilization of medical products, pharmaceuticals and bioproducts

    International Nuclear Information System (INIS)

    1967-01-01

    A Panel on the Radiosterilization of Medical Products, Pharmaceuticals and Bioproducts was convened by the International Atomic Energy Agency on 17-19 January 1966 at its headquarters in Vienna. The purpose of the meeting was to survey the activities of the Member States in this field with a view to preparing the way for an international code of practice for the radiosterilization of medical products, in conformity with existing legal international rules. Refs, figs and tabs

  7. Health risks of counterfeit pharmaceuticals.

    Science.gov (United States)

    ten Ham, Martijn

    2003-01-01

    Pharmaceutical products are not exempt from the practice of counterfeiting. In recent years, many reports have become available demonstrating the presence of fake medicines on the market. Several studies have demonstrated that they are quite often of bad quality. It is estimated that 5% of all world trade in branded goods is counterfeit, leading to huge financial losses for the pharmaceutical industry. But much more important, from a public health point of view, is that history has shown that such products may lead to a great health risk. The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product. The existence of counterfeit drugs has long been ignored both by the pharmaceutical industry and by drug regulatory authorities. At present initiatives are being taken, nationally and internationally, to curb counterfeiting. It is now realised that a strong regulatory agency is essential, but the initiatives can only be successful if all parties concerned actively co-operate.

  8. Stability of Pharmaceuticals in Space

    Science.gov (United States)

    Nguyen, Y-Uyen

    2009-01-01

    Stability testing is a tool used to access shelf life and effects of storage conditions for pharmaceutical formulations. Early research from the International Space Station (ISS) revealed that some medications may have degraded while in space. This potential loss of medication efficacy would be very dangerous to Crew health. The aim of this research project, Stability of Pharmacotherapeutic Compounds, is to study how the stability of pharmaceutical compounds is affected by environmental conditions in space. Four identical pharmaceutical payload kits containing medications in different dosage forms (liquid for injection, tablet, capsule, ointment and suppository) were transported to the ISS aboard a Space Shuttle. One of the four kits was stored on that Shuttle and the other three were stored on the ISS for return to Earth at various time intervals aboard a pre-designated Shuttle flight. The Pharmacotherapeutics laboratory used stability test as defined by the United States Pharmacopeia (USP), to access the degree of degradation to the Payload kit medications that may have occurred during space flight. Once these medications returned, the results of stability test performed on them were compared to those from the matching ground controls stored on Earth. Analyses of the results obtained from physical and chemical stability assessments on these payload medications will provide researchers additional tools to promote safe and efficacious medications for space exploration.

  9. People’s Republic of China and Federal Republic of Germany in current international relations in Central Asia

    Directory of Open Access Journals (Sweden)

    A V Tsvyk

    2014-12-01

    Full Text Available This article is devoted to the analysis of the current Sino-German relations in the context of world politics and dynamics of international relations as exemplified by the Central Asia region. Basic problems and prospects for cooperation between China and Germany in this region, as well as possible ways of cooperation of the SCO and the EU are under consideration.

  10. 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.

  11. 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.

  12. Methods for the comparative evaluation of pharmaceuticals

    Directory of Open Access Journals (Sweden)

    Busse, Reinhard

    2005-11-01

    Full Text Available Political background: As a German novelty, the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen; IGWiG was established in 2004 to, among other tasks, evaluate the benefit of pharmaceuticals. In this context it is of importance that patented pharmaceuticals are only excluded from the reference pricing system if they offer a therapeutic improvement. The institute is commissioned by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA or by the Ministry of Health and Social Security. The German policy objective expressed by the latest health care reform (Gesetz zur Modernisierung der Gesetzlichen Krankenversicherung, GMG is to base decisions on a scientific assessment of pharmaceuticals in comparison to already available treatments. However, procedures and methods are still to be established. Research questions and methods: This health technology assessment (HTA report was commissioned by the German Agency for HTA at the Institute for Medical Documentation and Information (DAHTA@DIMDI. It analysed criteria, procedures, and methods of comparative drug assessment in other EU-/OECD-countries. The research question was the following: How do national public institutions compare medicines in connection with pharmaceutical regulation, i.e. licensing, reimbursement and pricing of drugs? Institutions as well as documents concerning comparative drug evaluation (e.g. regulations, guidelines were identified through internet, systematic literature, and hand searches. Publications were selected according to pre-defined inclusion and exclusion criteria. Documents were analysed in a qualitative matter following an analytic framework that had been developed in advance. Results were summarised narratively and presented in evidence tables. Results and discussion: Currently licensing agencies do not systematically assess a new drug's added value for patients and society. This is why many

  13. Methods for the comparative evaluation of pharmaceuticals.

    Science.gov (United States)

    Zentner, Annette; Velasco-Garrido, Marcial; Busse, Reinhard

    2005-11-15

    POLITICAL BACKGROUND: As a German novelty, the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen; IGWiG) was established in 2004 to, among other tasks, evaluate the benefit of pharmaceuticals. In this context it is of importance that patented pharmaceuticals are only excluded from the reference pricing system if they offer a therapeutic improvement. The institute is commissioned by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) or by the Ministry of Health and Social Security. The German policy objective expressed by the latest health care reform (Gesetz zur Modernisierung der Gesetzlichen Krankenversicherung, GMG) is to base decisions on a scientific assessment of pharmaceuticals in comparison to already available treatments. However, procedures and methods are still to be established. This health technology assessment (HTA) report was commissioned by the German Agency for HTA at the Institute for Medical Documentation and Information (DAHTA@DIMDI). It analysed criteria, procedures, and methods of comparative drug assessment in other EU-/OECD-countries. The research question was the following: How do national public institutions compare medicines in connection with pharmaceutical regulation, i.e. licensing, reimbursement and pricing of drugs? Institutions as well as documents concerning comparative drug evaluation (e.g. regulations, guidelines) were identified through internet, systematic literature, and hand searches. Publications were selected according to pre-defined inclusion and exclusion criteria. Documents were analysed in a qualitative matter following an analytic framework that had been developed in advance. Results were summarised narratively and presented in evidence tables. Currently licensing agencies do not systematically assess a new drug's added value for patients and society. This is why many countries made post-licensing evaluation of pharmaceuticals a

  14. From Soft Power to Economic Diplomacy? A Comparison of the Changing Rationales and Roles of the U. S. and Canadian Federal Governments in International Education. Research & Occasional Paper Series: CSHE.2.15

    Science.gov (United States)

    Trilokekar, Roopa Desai

    2015-01-01

    Through a historical and comparative analysis of international education policy development in Canada and the U.S., this paper will map the similarities and differences in the two countries. It will highlight the contributions and challenges of the government's involvement in international education (IE) in the two federal states and in…

  15. Methods of promotion of nuclear research and development in the Federal Republic of Germany and international cooperation

    International Nuclear Information System (INIS)

    Lehr, G.

    1987-01-01

    The promotion of nuclear research and development in the Federal Republic of Germany is part of the overall R and D policy and is geared to the long-term energy policy goals. Nuclear energy development has been successfully promoted for more than thirty years, the non-nuclear energy technologies for almost 15 years. As a result of this support for new technologies, energy production has become more efficient and cost-effective and with regard to fossil energy sources also markedly less detrimental to the environment. Nuclear energy research policy is an integral part of energy research policy as a whole, which particularly aims to increasingly promote renewable energy sources, above all photovoltaic and wind energy, the utilization of biomass and geothermal energy as well as the development of various energy storage methods. In addition to some mining projects which aim to reduce coal production costs, promotion in the field of fossil energy sources concentrates above all on power plant engineering and combustion techniques - i.e. environment-oriented technologies. In view of future supply patterns, projects on coal conversion are continued; with present supply and price structures for mineral oil and natural gas, however, commercialization of coal conversion cannot be expected to be launched on a large scale. (J.P.N.)

  16. Availability of and access to orphan drugs: an international comparison of pharmaceutical treatments for pulmonary arterial hypertension, Fabry disease, hereditary angioedema and chronic myeloid leukaemia.

    Science.gov (United States)

    Blankart, Carl Rudolf; Stargardt, Tom; Schreyögg, Jonas

    2011-01-01

    Market authorization does not guarantee patient access to any given drug. This is particularly true for costly orphan drugs because access depends primarily on co-payments, reimbursement policies and prices. The objective of this article is to identify differences in the availability of orphan drugs and in patient access to them in 11 pharmaceutical markets: Australia, Canada, England, France, Germany, Hungary, the Netherlands, Poland, Slovakia, Switzerland and the US. Four rare diseases were selected for analysis: pulmonary arterial hypertension (PAH), Fabry disease (FD), hereditary angioedema (HAE) and chronic myeloid leukaemia (CML). Indicators for availability were defined as (i) the indications for which orphan drugs had been authorized in the treatment of these diseases; (ii) the application date; and (iii) the date upon which these drugs received market authorization in each country. Indicators of patient access were defined as (i) the outcomes of technology appraisals; (ii) the extent of coverage provided by healthcare payers; and (iii) the price of the drugs in each country. For PAH we analysed bosentan, iloprost, sildenafil, treprostinil (intravenous and inhaled) as well as sitaxentan and ambrisentan; for FD we analysed agalsidase alfa and agalsidase beta; for HAE we analysed icatibant, ecallantide and two complement C1s inhibitors; for CML we analysed imatinib, dasatinib and nilotinib. Most drugs included in this study had received market authorization in all countries, but the range of indications for which they had been authorized differed by country. The broadest range of indications was found in Australia, and the largest variations in indications were found for PAH drugs. Authorization process speed (the time between application and market authorization) was fastest in the US, with an average of 362 days, followed by the EU (394 days). The highest prices for the included drugs were found in Germany and the US, and the lowest in Canada, Australia and

  17. Tropical Journal of Pharmaceutical Research: Editorial Policies

    African Journals Online (AJOL)

    The Tropical Journal of Pharmaceutical Research is an Open Access international ... Although primarily devoted to original research papers, the journal ... know so that we can keep the authors informed and, where necessary, find alternatives. ..... An example of how a search strategy should be presented can be seen in the ...

  18. EU pharmaceutical expenditure forecast

    OpenAIRE

    Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    Background and Objectives: With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States’ ph...

  19. Federal Holidays

    Data.gov (United States)

    Office of Personnel Management — Federal law (5 U.S.C. 6103) establishes the following public holidays for Federal employees. Please note that most Federal employees work on a Monday through Friday...

  20. 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

  1. [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

  2. Bangladesh pharmaceutical policy and politics.

    Science.gov (United States)

    Reich, M R

    1994-06-01

    An analysis of the politics of Bangladesh pharmaceutical policy in the 1980s shows how significant health policy reforms in developing countries depend on political conditions both inside and outside the country. Bangladesh's drug policy of 1982 illustrates that governments can sometimes change public policy in ways unfavourable to multinational corporations, while the failed health policy reform of 1990 shows that reforms unfavourable to powerful domestic interest groups can be more difficult to achieve, even contributing to a government's downfall. The case provides evidence of basic changes in how the international agenda for health policy is set, especially the growing role of non-governmental organizations in international agencies and national policy debates. Understanding the political patterns of policy reform in Bangladesh has important implications for strategies to affect health policy in developing countries.

  3. Preoperative Magnetic Resonance Volumetry in Predicting Myometrial Invasion, Lymphovascular Space Invasion, and Tumor Grade: Is It Valuable in International Federation of Gynecology and Obstetrics Stage I Endometrial Cancer?

    Science.gov (United States)

    Sahin, Hilal; Sarioglu, Fatma Ceren; Bagci, Mustafa; Karadeniz, Tugba; Uluer, Hatice; Sanci, Muzaffer

    2018-05-01

    The aim of this retrospective single-center study was to evaluate the relationship between maximum tumor size, tumor volume, tumor volume ratio (TVR) based on preoperative magnetic resonance (MR) volumetry, and negative histological prognostic parameters (deep myometrial invasion [MI], lymphovascular space invasion, tumor histological grade, and subtype) in International Federation of Gynecology and Obstetrics stage I endometrial cancer. Preoperative pelvic MR imaging studies of 68 women with surgical-pathologic diagnosis of International Federation of Gynecology and Obstetrics stage I endometrial cancer were reviewed for assessment of MR volumetry and qualitative assessment of MI. Volume of the tumor and uterus was measured with manual tracing of each section on sagittal T2-weighted images. Tumor volume ratio was calculated according to the following formula: TVR = (total tumor volume/total uterine volume) × 100. Receiver operating characteristics curve was performed to investigate a threshold for TVR associated with MI. The Mann-Whitney U test, Kruskal-Wallis test, and linear regression analysis were applied to evaluate possible differences between tumor size, tumor volume, TVR, and negative prognostic parameters. Receiver operating characteristics curve analysis of TVR for prediction of deep MI was statistically significant (P = 0.013). An optimal TVR threshold of 7.3% predicted deep myometrial invasion with 85.7% sensitivity, 46.8% specificity, 41.9% positive predictive value, and 88.0% negative predictive value. Receiver operating characteristics curve analyses of TVR, tumor size, and tumor volume for prediction of tumor histological grade or lymphovascular space invasion were not significant. The concordance between radiologic and pathologic assessment for MI was almost excellent (κ value, 0.799; P volumetry, seems to predict deep MI independently in stage I endometrial cancer with insufficient sensitivity and specificity. Its value in clinical practice for

  4. Internal social responsibility: the perception of the public servants from a federal institution; Responsabilidade social interna: a percepção dos servidores públicos de uma autarquia federal

    Energy Technology Data Exchange (ETDEWEB)

    Laranja, Leticia Cruz

    2017-07-01

    The paper aims to analyze the perception of public servants from a federal autarchy regarding its practices, actions and Corporate Social Responsibility programs towards its servants, as well as proposing improvements. Thus, a revision of the existing literature on the evolution of Corporate Social Responsibility was carried out, as well as its applications on the public sector and inside its organizations. The quantitative-descriptive research was performed from a survey using a closed questionnaire developed from the Ethos Indicators focused on workforce. The research results indicated the dominance of a negative perception by the servants regarding Internal Social Responsibility practices in the autarchy, as well as the dominant negative perception from servants without leadership positions and with shorter length of service against the point of view of servants that occupy leadership positions and with longer length of service. The research allowed the identification of practices related to Working Conditions, Working Day and Life Quality as being more relevant, and practices regarding Unions Relations as being the least relevant for servants. In order to improve the perception of the servants on the issues evaluated negatively it is recommended to developed actions and programs related to professional development, employability and retirement, health and safety, working conditions and life quality, and to developed actions aimed at employees without leadership positions and with shorter length of service, whose perceptions were more negative. (author)

  5. 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.

  6. Communication of 29 April 1996 received from the permanent mission of the Russian Federation to the International Atomic Energy Agency regarding guidelines for the export of nuclear material, equipment and technology

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-06-07

    The Director General of the International Atomic Energy Agency has received a note verbale of 29 April 1996 from the Permanent Mission of the Russian Federation providing information on the export policies and practices of the Government of the Russian Federation with respect to nuclear transfers. In light of the request expressed in the note verbale, the text of the note verbale and its attachment is being circulated.

  7. Communication of 29 April 1996 received from the permanent mission of the Russian Federation to the International Atomic Energy Agency regarding guidelines for the export of nuclear material, equipment and technology

    International Nuclear Information System (INIS)

    1996-01-01

    The Director General of the International Atomic Energy Agency has received a note verbale of 29 April 1996 from the Permanent Mission of the Russian Federation providing information on the export policies and practices of the Government of the Russian Federation with respect to nuclear transfers. In light of the request expressed in the note verbale, the text of the note verbale and its attachment is being circulated

  8. 76 FR 78966 - Federal Aviation Administration

    Science.gov (United States)

    2011-12-20

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Approval of Noise Compatibility Program for Kona International Airport at Keahole, Keahole, North Kona, HI AGENCY: Federal Aviation Administration, DOT. ACTION: Notice. SUMMARY: The Federal Aviation Administration (FAA) announces its findings on...

  9. [Fourcroy and pharmaceutical journals].

    Science.gov (United States)

    Bonnemain, Bruno

    2011-04-01

    Cadet de Gassicourt wrote a brief Eloge of Fourcroy in January 1810 as he died in December of 1809. Fourcroy had a major role concerning the new ideas on the place of pharmacy at the beginning of the 19th century. Fourcroy has had a key influence for the start of several pharmaceutical journals that wanted to emphasize the link between the new chemistry and pharmacy. None of these journals created with him will survive and one has to wait for 1909 to see the creation, without Fourcroy, of a new pharmaceutical journal, the "Journal de Pharmacie" that will become "Journal de Pharmacie et des Sciences accessoires", then "Journal de Pharmacie et de Chimie", before taking the name of"Annales Pharmaceutiques Françaises", the present official journal of the French Academy of Pharmacy. In spite of the essential role of Fourcroy at the start of pharmaceutical journals, Cadet did not even mention it in his Eloge of 1810.

  10. Rheology in Pharmaceutical Sciences

    DEFF Research Database (Denmark)

    Aho, Johanna; Hvidt, Søren; Baldursdottir, Stefania

    2016-01-01

    Rheology is the science of flow and deformation of matter. Particularly gels and non-Newtonian fluids, which exhibit complex flow behavior, are frequently encountered in pharmaceutical engineering and manufacturing, or when dealing with various in vivo fluids. Therefore understanding rheology......, together with the common measurement techniques and their practical applications. Examples of the use of rheological techniques in the pharmaceutical field, as well as other closely related fields such as food and polymer science, are also given....... is important, and the ability to use rheological characterization tools is of great importance for any pharmaceutical scientist involved in the field. Flow can be generated by shear or extensional deformations, or a combination of both. This chapter introduces the basics of both shear and extensional rheology...

  11. Pharmaceutical supply chain risks: a systematic review

    Science.gov (United States)

    2013-01-01

    Introduction Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. Objective In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Methods Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Results Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. Conclusion It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies. PMID:24355166

  12. Pharmaceutical supply chain risks: a systematic review.

    Science.gov (United States)

    Jaberidoost, Mona; Nikfar, Shekoufeh; Abdollahiasl, Akbar; Dinarvand, Rassoul

    2013-12-19

    Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies.

  13. Conceptualizing Pharmaceutical Plants

    DEFF Research Database (Denmark)

    Larsen, Bent Dalgaard; Jensen, Klaes Ladeby; Gjøl, Mikkel

    2006-01-01

    In the conceptual design phase of pharmaceutical plants as much as 80%-90% of the total cost of a project is committed. It is therefore essential that the chosen concept is viable. In this design process configuration and 3D models can help validate the decisions made. Designing 3D models...... is a complex task and requires skilled users. We demonstrate that a simple 2D/3D configuration tool can support conceptualizing of pharmaceutical plants. Present paper reports on preliminary results from a full scale implementation project at a Danish engineering company....

  14. 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.

  15. MARKETING STRATEGIES OF PHARMACEUTICAL ORGANIZATION

    Directory of Open Access Journals (Sweden)

    N. M. Sergeeva

    2015-01-01

    Full Text Available Strategy of pharmaceutical goods (PG promotion is a working out of methods of goods realization stimulation. To make PG promotion maximum effective, and to receive a sufficient result for pharmaceutical organization (PO it is necessary to conduct marketing studies (MS, to work out a marketing plan for PG promotion and to offer marketing strategies for goods promotion. To resolve these problems we have formed a concept of marketing promotion of PG system for one of big retail PO of Kursk and Kursk oblast (code name “A”. With this purpose we have identified a problem of PG promotion organization, studied an influence of external and internal environment on the PO “A” activity, determined strong and weak sides of PO activity. We have systematized the results in SWOT-analysis, and formed the strategies of PO for the improvement of work efficiency on the market. On the basis of the results received we have worked out the recommendations for the marketing strategies of PG promotion for the certain PO.

  16. Pharmaceutical packaging handbook

    National Research Council Canada - National Science Library

    Bauer, Edward J

    2009-01-01

    ... of the modern world. Pharmaceutical products and health care in developing countries and remote parts of the world seems like magic. Diseases that were once fatal and chronic conditions that destroyed lives have slowly been conquered by modern medicine. Views of the body, unimaginable for most of the last century with X rays, are now possible with new i...

  17. 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.

  18. The Effectiveness of Pharmaceutical Marketing

    NARCIS (Netherlands)

    E.R. Kappe

    2011-01-01

    textabstractPharmaceutical marketing effectiveness comprises the measurement of marketing efforts of pharmaceutical firms towards doctors and patients. These firms spend billions of dollars yearly to promote their prescription drugs. This dissertation provides empirical analyses and methods to

  19. Structural changes in the German pharmaceutical market: price setting mechanisms based on the early benefit evaluation.

    Science.gov (United States)

    Henschke, Cornelia; Sundmacher, Leonie; Busse, Reinhard

    2013-03-01

    In the past, free price setting mechanisms in Germany led to high prices of patented pharmaceuticals and to increasing expenditures in the pharmaceutical sector. In order to control patented pharmaceutical prices and to curb increasing pharmaceutical spending, the Act for Restructuring the Pharmaceutical Market in Statutory Health Insurance (AMNOG) came into effect on 1st January 2011. In a structured dossier, pharmaceutical manufacturers have to demonstrate the additional therapeutic benefit of the newly approved pharmaceutical compared to its appropriate comparator. According to the level of additional benefit, pharmaceuticals will be subject to price negotiations between the Federal Association of Statutory Health Insurance Funds and the pharmaceutical company concerned (or assigned to a reference price group in case of no additional benefit). Therefore, the health care reform is a first step to decision making based on "value for money". The process of price setting based on early benefit evaluation has an impact on the German as well as the European pharmaceutical markets. Therefore, these structural changes in Germany are of importance for pricing decisions in many European countries both from a political point of view and for strategic planning for pharmaceutical manufacturers, which may have an effect on insured patients' access to pharmaceuticals. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  20. 77 FR 16262 - Importer of Controlled Substances, Notice of Registration; Johnson Matthey, Inc., Pharmaceutical...

    Science.gov (United States)

    2012-03-20

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances, Notice of Registration; Johnson Matthey, Inc., Pharmaceutical Materials By Notice dated December 2, 2011, and published in the Federal Register on December 12, 2011, 76 FR 77253, Johnson Matthey, Inc., Pharmaceutical...

  1. 78 FR 51210 - Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical, Inc.

    Science.gov (United States)

    2013-08-20

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical, Inc. Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 8, 2013, Halo Pharmaceutical, Inc., 30 North...

  2. 78 FR 12101 - Importer of Controlled Substances; Notice of Application; Caraco Pharmaceutical Laboratories, LTD.

    Science.gov (United States)

    2013-02-21

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Caraco Pharmaceutical Laboratories, LTD. Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on November 22, 2012, Caraco Pharmaceutical Laboratories, Ltd., 270 Prospect...

  3. 77 FR 47114 - Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical Inc.

    Science.gov (United States)

    2012-08-07

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical Inc. Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 6, 2012, Halo Pharmaceutical Inc., 30 North...

  4. Federalism Lives.

    Science.gov (United States)

    Howard, A. E. Dick

    1987-01-01

    Examines the concept of federalism in terms of its past history and its encouraging future. Calls for a revival of concern for federalism not simply as a convenient administrative arrangement but as a fundamental constitutional value. (BSR)

  5. Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group.

    Science.gov (United States)

    Lis, Yvonne; Roberts, Melissa H; Kamble, Shital; J Guo, Jeff; Raisch, Dennis W

    2012-12-01

    1) To compare the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategies (REMS) and European Medicines Agency's (EMA's) Risk Management Plan (RMP) guidances and 2) to compare REMS and RMPs for specific chemical entities and biological products. FDA, EMA, and pharmaceutical company Web sites were consulted for details pertaining to REMS and RMPs. REMS requirements include medication guides, communication plans, elements to ensure safe use, implementation systems, and specified assessment intervals. RMP requirements are increased pharmacovigilance and risk minimization activities. We compared these requirements for drugs requiring both REMS and RMPs. We identified 95 drugs on FDA's REMS list as of March 2010. Of these, there were 29 drugs (11 biologics and 18 new chemical entities) with EMA RMPs. REMS and RMPs are similar in objectives, with comparable toolkits. Both allow flexibility in product-specific actions, recognizing adverse effects of potential concern. Of the 29 drugs reviewed, REMS requirements not included in RMPs were patient medication guides (100% of the drugs), provider communication plans (38%), and routine monitoring of REMS (66%). RMP requirements not included in REMS were specific adverse event reporting (45% of the drugs), prospective registry studies (34%), prospective epidemiology studies (24%), additional trial data (28%), and Summary of Product Characteristics contraindications (76%). Both REMS and RMPs provide positive guidance for identification, monitoring, and minimization of risk to patient safety. Currently, neither agency provides specific guidance on how risk should be related to benefit either qualitatively or quantitatively. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  6. Understanding Federalism.

    Science.gov (United States)

    Hickok, Eugene W., Jr.

    1990-01-01

    Urges returning to the original federalist debates to understand contemporary federalism. Reviews "The Federalist Papers," how federalism has evolved, and the centralization of the national government through acts of Congress and Supreme Court decisions. Recommends teaching about federalism as part of teaching about U.S. government…

  7. Communication from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency regarding the export of nuclear material and of certain categories of equipment and other material

    International Nuclear Information System (INIS)

    2000-01-01

    The document reproduces the text of a letter received by the Director general of the IAEA from Permanent Mission of the Russian Federation to the International Atomic Energy Agency concerning the export of nuclear material and of certain categories of equipment and other material

  8. EU pharmaceutical expenditure forecast.

    Science.gov (United States)

    Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States' pharmaceutical budgets. This model took into account population ageing, as well as current and future country-specific pricing, reimbursement, and market access policies (the project was performed for the European Commission; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). In order to have a representative heterogeneity of EU Member States, the following countries were selected for the analysis: France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. A forecasting period of 5 years (2012-2016) was chosen to assess the net pharmaceutical budget impact. A model for generics and biosimilars was developed for each country. The model estimated a separate and combined effect of the direct and indirect impacts of the patent cliff. A second model, estimating the sales development and the risk of development failure, was developed for new drugs. New drugs were reviewed individually to assess their clinical potential and translate it into commercial potential. The forecast was carried out according to three perspectives (healthcare public payer, society, and manufacturer), and several types of distribution chains (retail, hospital, and combined retail and hospital). Probabilistic and deterministic sensitivity analyses were carried out. According to the model, all countries experienced drug budget reductions except Poland (+€41 million). Savings were expected to be the highest in the United Kingdom (-€9,367 million), France (-€5,589 million), and, far behind them

  9. 11 July 2012 - Extraordinary and Plenipotentiary Ambassador M. Alemu Getahun, Permanent Representative of the Federal Democratic Republic of Ethiopia to the United Nations Office and other international organisations in Geneva signing the guest book with Head of International relations F. Pauss.

    CERN Multimedia

    Maximilien Brice

    2012-01-01

    11 July 2012 - Extraordinary and Plenipotentiary Ambassador M. Alemu Getahun, Permanent Representative of the Federal Democratic Republic of Ethiopia to the United Nations Office and other international organisations in Geneva signing the guest book with Head of International relations F. Pauss.

  10. Pharmaceutical applications of magnetic resonance imaging (MRI).

    Science.gov (United States)

    Richardson, J Craig; Bowtell, Richard W; Mäder, Karsten; Melia, Colin D

    2005-06-15

    Magnetic resonance imaging (MRI) is a powerful imaging modality that provides internal images of materials and living organisms on a microscopic and macroscopic scale. It is non-invasive and non-destructive, and one of very few techniques that can observe internal events inside undisturbed specimens in situ. It is versatile, as a wide range of NMR modalities can be accessed, and 2D and 3D imaging can be undertaken. Despite widespread use and major advances in clinical MRI, it has seen limited application in the pharmaceutical sciences. In vitro studies have focussed on drug release mechanisms in polymeric delivery systems, but isolated studies of bioadhesion, tablet properties, and extrusion and mixing processes illustrate the wider potential. Perhaps the greatest potential however, lies in investigations of pharmaceuticals in vivo, where pilot human and animal studies have demonstrated we can obtain unique insights into the behaviour of gastrointestinal, topical, colloidal, and targeted drug delivery systems.

  11. Brightening up: the effect of the Physician Payment Sunshine Act on existing regulation of pharmaceutical marketing.

    Science.gov (United States)

    Gorlach, Igor; Pham-Kanter, Genevieve

    2013-01-01

    With the passage of the Physician Payment Sunshine Act as part of the federal health care reform law, pharmaceutical manufacturers are now required to disclose a wide range of payments made by manufacturers to physicians. We review current state regulation of pharmaceutical marketing and consider how the federal sunshine provision will affect existing marketing regulation. We analyze the legal and practical implications of the Physician Payment Sunshine Act. © 2013 American Society of Law, Medicine & Ethics, Inc.

  12. Pharmaceutical new product development: the increasing role of in-licensing.

    Science.gov (United States)

    Edwards, Nancy V

    2008-12-01

    Many pharmaceutical companies are facing a pipeline gap because of the increasing economic burden and uncertainty associated with internal research and development programs designed to develop new pharmaceutical products. To fill this pipeline gap, pharmaceutical companies are increasingly relying on in-licensing opportunities. New business development identifies new pharmaceuticals that satisfy unmet needs and are a good strategic fit for the company, completes valuation models and forecasts, evaluates the ability of the company to develop and launch products, and pursues in-licensing agreements for pharmaceuticals that cannot be developed internally on a timely basis. These agreements involve the transfer of access rights for patents, trademarks, or similar intellectual property from an outside company in exchange for payments. Despite the risks, in-licensing is increasingly becoming the preferred method for pharmaceutical companies with pipeline gaps to bring new pharmaceuticals to the clinician.

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

    Science.gov (United States)

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

    2015-11-01

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

  14. Approaches to education of pharmaceutical biotechnology in faculties of pharmacy.

    Science.gov (United States)

    Calis, S; Oner, F; Kas, S; Hincal, A A

    2001-06-01

    Pharmaceutical biotechnology is developing rapidly both in academic institutions and in the biopharmaceutical industry. For this reason, FIP Special Interest Group of Pharmaceutical Biotechnology decided to develop a questionnaire concerning pharmaceutical biotechnology education. After preliminary studies were completed, questionnaires were sent to the leading scientists in academia and research directors or senior managers of various Pharmaceutical Biotechnology Companies in order to gather their views about how to create a satisfactory program. The objectives of this study were as follows: -To review all of the graduate and undergraduate courses which are presently available worldwide on pharmaceutical biotechnology in Faculties of Pharmacy. -To review all of the text books, references and scientific sources available worldwide in the area of pharmaceutical biotechnology. When replying to the questionnaires, the respondents were asked to consider the present status of pharmaceutical biotechnology education in academia and future learning needs in collaboration with the biotechnology industry. The data from various pharmacy faculties and biotechnology industry representatives from Asia, Europe and America were evaluated and the outcome of the survey showed that educational efforts in training qualified staff in the rapidly growing field of pharmaceutical biotechnology is promising. Part of the results of this questionnaire study have already been presented at the 57th International Congress of FIP Vancouver, Canada in 1997.

  15. Pharmaceutical market in Serbia

    Directory of Open Access Journals (Sweden)

    Veselin Tima Dickov

    2012-02-01

    Full Text Available Marketing concept formed around the focus on the consumers, their needs, wants and demands, evolves in the case of pharmaceutical into a care of the complex interest of constituents generating demand on this market and #8211; pres scribers whose role is to select therapies, pharmacists who dispense drugs within a specialized distribution channel to the final consumer -patient, alongside the payers and #8211; the state and or insurance companies refund a part of or total costs of the pharmaceutical product. A special challenge that the subject raises is the existence of controversy generated from two sources. Marketing controversy stems from criticism leveled at the effectiveness and efficiency of marketing activities and the debatable ethical code of conduct. [J Intercult Ethnopharmacol 2012; 1(1.000: 44-51

  16. Planejamento das atividades de auditoria interna nas universidades federais brasileiras: apresentação do embasamento normativo = Planning of the internal audit activities in Brazilian federal universities: presentation of the normative bases

    Directory of Open Access Journals (Sweden)

    Orion Augusto Platt Neto

    2008-07-01

    Full Text Available Este artigo apresenta um enfoque normativo sobre o planejamento anual que deve serrealizado nas unidades de auditoria interna, componentes da estrutura administrativadas universidades federais brasileiras. Deste modo, o objetivo do artigo é apresentar asnormas relativas à elaboração e ao acompanhamento da execução do plano anual deatividades de auditoria interna, que devem ser seguidas pelas universidades federais.Trata-se de umapesquisa aplicada, de natureza qualitativa e de caráter exploratório. O âmbito da pesquisaé restrito às instituições dedicadas ao ensino superior, componentes da administraçãoindireta na esfera federal brasileira. Foi utilizada a análise documental da legislação brasileira sobre controle e auditoria interna na administração pública. A pesquisa queembasou o artigo justifica-se, entre outros motivos, como contribuição à literatura daárea, que sofre escassez quanto às referências direcionadas para a auditoria interna nasuniversidades. Como resultados, foram apresentadas as bases normativas mais recentesque regulam as o planejamento das atividades de auditoria interna nas universidadesfederais, bem como a elaboração do Plano Anual de Atividades da Auditoria Interna (PAINT.As ações de auditoria interna nas universidades federais têm sua base normativa derivadada Constituição Federal de 1988, que, nos artigos 70 e 74, trata do sistema de controleinterno do Poder Executivo Federal. A partir disso, o Decreto Presidencial nº 3.591/00definiu atribuições à Controladoria-Geral da União (CGU e à Secretaria Federal de Controle Interno (SFC para a edição de instruções normativas sobre controle e auditoria interna.This paper presents a normative approach about the annual planning that must becarried through by internal audit units that compose the administrative structure of theBrazilian federal universities. This way, the objective of the paper is to present thespecific rules related to the

  17. Resumed Publication of Pharmaceuticals in 2009

    Directory of Open Access Journals (Sweden)

    Shu-Kun Lin

    2009-04-01

    Full Text Available After a five year hiatus, we are pleased to announce the resumption of publication of the MDPI journal Pharmaceuticals (ISSN 1424-8247. First launched in 2004, few suitable papers were submitted and only one was published [1], before our limited editorial resources at the time led us to temporarily discontinue publication. Several things have changed since then. First, there has been an explosive growth in the number of manuscripts submitted and published in MDPI’s various current journals [2], whose topics clearly fall within the intended scope of Pharmaceuticals and we feel that these manuscripts merit a dedicated forum. Second, the expansion of MDPI, now with Editorial Offices and staff in Basel (Switzerland and Beijing (China, allows us to provide Pharmaceuticals’ authors with all the services they could desire and deserve: a simple manuscript submission process, rigorous peer review, quick revision turnaround, Open Access publication on a new and attractive platform and coverage by all the major abstracting services. In addition, a new Editorial Board comprised of noted academic and industry scientists has been set up for Pharmaceuticals. Finally, to better focus the subject matter published in Pharmaceuticals on molecular medicines, we have also set up a special section in International Journal of Molecular Sciences (IJMS, ISSN 1422-0067 for papers on nutraceuticals or chemopreventives. We look forward to receiving and publishing your papers and as always, we welcome your comments and suggestions.

  18. [Logistics in the pharmaceutical service].

    Science.gov (United States)

    Stanko, P; Fulmeková, M

    2005-11-01

    The conception of the field of pharmaceutical service defines pharmaceutical service as the basic part of pharmacy, the principal task of which is to provide pharmaceutical care as an inseparable part of providing health care. It represents a set of professional activities of the pharmacist oriented to securing human and veterinary pharmaceutical products and health care products and to optimising effective, safe and quality pharmacotherapy. Technically, pharmaceutical service is an applied discipline, as it makes use of knowledge gained in other pharmaceutical, medical, psychological, social, and economic sciences. Because of its interdisciplinary character it is necessary to extend the theory of pharmaceutical service in such a way so that it may reflect all aspects of its sphere of activity. One of the possibilities is to define the pharmacy premises as an independent functional unit which operates on the basis of valid legal standards in such a way that on the one hand it secures the provision of health (pharmaceutical) care, and on the other hand it maintains its cost-effectiveness. To keep the quality of care of the patient and the economic aspect in balance, it is necessary to define the term pharmaceutical logistics also under the conditions of Slovak (Czech) pharmacy as early satisfaction of the requirements of the patient (client) in the pharmacy premises, which means that the appropriate pharmaceutical product or health care product and the appropriate information must be at the right time in the required amount and required quality in the right place.

  19. Standardization of clinical enzyme analysis using frozen human serum pools with values assigned by the International Federation of Clinical Chemistry and Laboratory Medicine reference measurement procedures.

    Science.gov (United States)

    Tong, Qing; Chen, Baorong; Zhang, Rui; Zuo, Chang

    Variation in clinical enzyme analysis, particularly across different measuring systems and laboratories, represents a critical but long-lasting problem in diagnosis. Calibrators with traceability and commutability are imminently needed to harmonize analysis in laboratory medicine. Fresh frozen human serum pools were assigned values for alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), creatine kinase (CK) and lactate dehydrogenase (LDH) by six laboratories with established International Federation of Clinical Chemistry and Laboratory Medicine reference measurement procedures. These serum pools were then used across 76 laboratories as a calibrator in the analysis of five enzymes. Bias and imprecision in the measurement of the five enzymes tested were significantly reduced by using the value-assigned serum in analytical systems with open and single-point calibration. The median (interquartile range) of the relative biases of ALT, AST, GGT, CK and LDH were 2.0% (0.6-3.4%), 0.8% (-0.8-2.3%), 1.0% (-0.5-2.0%), 0.2% (-0.3-1.0%) and 0.2% (-0.9-1.1%), respectively. Before calibration, the interlaboratory coefficients of variation (CVs) in the analysis of patient serum samples were 8.0-8.2%, 7.3-8.5%, 8.1-8.7%, 5.1-5.9% and 5.8-6.4% for ALT, AST, GGT, CK and LDH, respectively; after calibration, the CVs decreased to 2.7-3.3%, 3.0-3.6%, 1.6-2.1%, 1.8-1.9% and 3.3-3.5%, respectively. The results suggest that the use of fresh frozen serum pools significantly improved the comparability of test results in analytical systems with open and single-point calibration.

  20. First International Conference on Lysophospholipids and Related Bioactive Lipids in Biology and Disease Sponsored by the Federation of American Societies of Experimental Biology

    Directory of Open Access Journals (Sweden)

    Edward J. Goetzl

    2001-01-01

    Full Text Available The First International Conference on “Lysophospholipids and Related Bioactive Lipids in Biology and Diseases” was held in Tucson, AZ on June 10�14, 2001, under the sponsorship of the Federation of American Societies of Experimental Biology (FASEB. More than 100 scientists from 11 countries discussed the recent results of basic and clinical research in the broad biology of this emerging field. Immense progress was reported in defining the biochemistry of generation and biology of cellular effects of the bioactive lysophospholipids (LPLs. These aspects of LPLs described at the conference parallel in many ways those of the eicosanoid mediators, such as prostaglandins and leukotrienes. As for eicosanoids, the LPLs termed lysophosphatidic acid (LPA and sphingosine 1-phosphate (S1P are produced enzymatically from phospholipid precursors in cell membranes and act on cells at nanomolar concentrations through subfamilies of receptors of the G protein–coupled superfamily. The rate-limiting steps in production of LPLs were reported to be controlled by specific phospholipases for LPA and sphingosine kinases for S1P. The receptor subfamilies formerly were designated endothelial differentiation gene-encoded receptors or Edg Rs for their original discovery in endothelial cells. A currently active nomenclature committee at this conference suggested the ligand-based names: S1P1 = Edg-1, S1P2 = Edg-5, S1P3 = Edg-3, S1P4 = Edg-6, and S1P5 = Edg-8; LPA1 = Edg-2, LPA2 = Edg-4, and LPA3 = Edg-7 receptors. Several families of lysophospholipid phosphatases (LPPs have been characterized, which biodegrade LPA, whereas S1P is inactivated with similar rapidity by both a lyase and S1P phosphatases.

  1. Prevalence of Metabolic Syndrome among Malaysians using the International Diabetes Federation, National Cholesterol Education Program and Modified World Health Organization Definitions.

    Science.gov (United States)

    Bee, Ying Tan; Haresh, Kumar Kantilal; Rajibans, Singh

    2008-03-01

    The World Health Organization (WHO), National Cholesterol Education Program Adults Treatment Panel III (NCEP ATP III) and International Diabetes Federation (IDF) have proposed different criteria to diagnose metabolic syndrome (MetS). However, there is no single definition to accurately diagnose MetS. The objective of this study is to estimate the prevalence of MetS using WHO, NCEP ATP III and IDF in the Malaysian community, and to determine the concordance between these definitions for MetS. 109 men and women aged > 30 years participated in the study, and the prevalence of MetS was determined according to the three definitions. Weight, height, body mass index (BMI), waist-hip circumference, blood pressure, blood lipid profile and plasma fasting glucose were measured. In order to determine the concordance between IDF and the other two definitions, the kappa index (κ-test) was used. The prevalence of MetS (95% confidence interval) was 22.9% (22.8-23.1) by IDF definition, 16.5% (16.3-16.9) by NCEP ATP III definition and 6.4% (6.2-6.6) by modified WHO definition. The sensitivity and specificity of IDF against NCEP ATP III were 88.9% and 90.1% respectively, IDF against WHO definition were 85.7% and 81.4%. The κ statistics for the agreement of the IDF definition was 68.3 ± 0.1 with the NCEP ATP III, and 30.5 ± 0.1 with the modified WHO definition. The prevalence of the MetS among respondents using the IDF definition was highest, followed by NCEP ATP III, and finally modified WHO definition. There was a good concordance between the IDF and NCEP ATP III definitions, and a low concordance between IDF and modified WHO definitions.

  2. Prevalence of metabolic syndrome among staff in a Malaysian public university based on Harmonised, International Diabetes Federation and National Cholesterol Education Program Definitions.

    Science.gov (United States)

    Heng, K S; Hejar, A R; Rushdan, A Z; Loh, S P

    2013-04-01

    Metabolic syndrome (MetSyn) as defined by the latest Harmonised definition and the agreement between the Harmonised definition and other definitions is poorly studied among Malaysians. This study was conducted to determine and compare the prevalence of MetSyn according to the Harmonised, International Diabetes Federation (IDF) and National Cholesterol Education Program (NCEP ATPIII) definitions among Malay staff of Universiti Putra Malaysia (UPM). Subjects aged between 20 to 65 years were recruited by convenient sampling. Waist circumference, blood pressure, lipid profiles and fasting plasma glucose levels were assessed. The agreement between the Harmonised and other definitions was determined by Kappa statistics. A total of 227 subjects with a mean +/- SD age of 37.9 +/- 9.6 years participated in the study. The overall prevalence of MetSyn was 38.3%, 38.8% and 33.5% according to Harmonised, IDF and NCEP ATP III definitions, respectively. Generally, men had higher prevalence of MetSyn than women. The prevalence increased with age in both genders with a more progressive trend in women. Men in the age group of 20-39 years had a high prevalence of metabolic syndrome. A strong agreement was found between the Harmonised and the IDF definitions (Kappa index = 0.991), and between the Harmonised and the NCEP ATP III definitions (Kappa index = 0.857). Regardless of definitions used, the prevalence of metabolic syndrome in the study, especially in young men, was high and warrants further investigation. The Harmonised definition is suitable for diagnosing metabolic syndrome in any population with similar sociodemographic characteristics.

  3. Communication from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency regarding guidelines for transfers of nuclear-related dual-use equipment, materials, software and related technology

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-12-10

    The Director General of the International Atomic Energy Agency has received a Note Verbale from the Permanent Mission of the Russian Federation providing information on the export policies and practices of the Government of the Russian Federation with respect to the export of nuclear-related dual-use equipment, materials, software and related technology. In the light of the wish expressed at the end of the Note Verbale, the text of the Note Verbale is attached. The attachment to the Note Verbale was issued previously as INFCIRC/2541Rev. 4/Part 2.

  4. Communication from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency regarding guidelines for transfers of nuclear-related dual-use equipment, materials, software and related technology

    International Nuclear Information System (INIS)

    2001-01-01

    The Director General of the International Atomic Energy Agency has received a Note Verbale from the Permanent Mission of the Russian Federation providing information on the export policies and practices of the Government of the Russian Federation with respect to the export of nuclear-related dual-use equipment, materials, software and related technology. In the light of the wish expressed at the end of the Note Verbale, the text of the Note Verbale is attached. The attachment to the Note Verbale was issued previously as INFCIRC/2541Rev. 4/Part 2

  5. Risk factors associated with metabolic syndrome in type 2 diabetes mellitus patients according to World Health Organization, Third Report National Cholesterol Education Program, and International Diabetes Federation definitions

    Directory of Open Access Journals (Sweden)

    Angel Rodríguez

    2010-12-01

    Full Text Available Angel Rodríguez1, Helena Delgado-Cohen1, Jesús Reviriego1, Manuel Serrano-Ríos21Clinical Research Department, Eli Lilly and Company, Madrid, Spain; 2Department of Internal Medicine II, Hospital Clinico San Carlos, Madrid, SpainBackground: The availability of several definitions of the metabolic syndrome has created potential confusion concerning its prognostic utility. At present, little data exist about the risk factors associated with metabolic syndrome in diabetic patients.Aim: To identify risk factors associated with metabolic syndrome in patients with type 2 diabetes mellitus according to three diagnostic criteria: World Health Organization (WHO, Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults – Adult Treatment Panel III (NCEP-ATP III, and International Diabetes Federation (IDF.Subjects and methods: A logistic regression model was used to identify demographic, clinical, and lifestyle variables related with metabolic syndrome (N = 1259.Results: Hypertension, dyslipidemia, and glycosylated hemoglobin (HbA1c ≥7% were associated with increased risk of WHO-defined metabolic syndrome (odds ratio [OR], 2.33; 95% confidence interval [CI]: 1.60–3.40; OR, 1.79 95% CI: 1.25–2.55; and OR, 1.58; 95% CI: 1.12–2.22, respectively. The risk of presenting metabolic syndrome according to NCEP-ATP III criteria was increased in female patients (OR, 2.02; 95% CI: 1.37–2.97, elevated fasting glucose levels (OR, 5.99; 95% CI: 3.56–10.07, dyslipidemia (OR, 2.28; 95% CI: 1.57–3.32, hypertension (OR, 2.36; 95% CI: 1.59–3.53, and endocrine disorders (OR, 1.64; 95% CI: 1.06–2.57. For the IDF criteria, female patients and patients with left ventricular hypertrophy or insulin treatment were at higher risk of metabolic syndrome (OR, 4.00; 95% CI: 2.35–6.80; OR, 2.72 95% CI: 1.22–6.04; and OR, 1.96 95% CI: 1.24–3.11, respectively.Conclusions: The

  6. 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.

  7. 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.

  8. 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

  9. 3. Radioactive pharmaceutical medications

    International Nuclear Information System (INIS)

    2006-01-01

    In the chapter common definitions of for radio-pharmacy are given. Radio-pharmacy medications are pharmacy medications which contain minor amount of one or several radionuclides (radioactive tracers), those radiation ability is applying in diagnostic or therapeutic purposes. At the same time radionuclides with more short life time, which are ether gamma-radiators or beta-radiators are applying. The following items for such radioisotopes production; radionuclides applying in nuclear medicine; radio-pharmaceutics; radio-toxicity; quality insurance; order for 18 F-PDG production; radionuclide analysis are considered

  10. Regulation of Pharmaceutical Prices

    DEFF Research Database (Denmark)

    Kaiser, Ulrich; Mendez, Susan J.; Rønde, Thomas

    On April 1, 2005, Denmark changed the way references prices, a main determinant of reimbursements for pharmaceutical purchases, are calculated. The previous reference prices, which were based on average EU prices, were substituted to minimum domestic prices. Novel to the literature, we estimate...... the joint eects of this reform on prices and quantities. Prices decreased more than 26 percent due to the reform, which reduced patient and government expenditures by 3.0 percent and 5.6 percent, respectively, and producer revenues by 5.0 percent. The prices of expensive products decreased more than...

  11. Federal Investment

    Science.gov (United States)

    Campbell, Sheila; Tawil, Natalie

    2013-01-01

    The federal government pays for a wide range of goods and services that are expected to be useful some years in the future. Those purchases, called investment, fall into three categories: physical capital, research and development (R&D), and education and training. There are several economic rationales for federal investment. It can provide…

  12. Active methodology and blended learning: An experience in pharmaceutical care.

    Science.gov (United States)

    Czepula, Alexandra Ingrid Dos Santos; Bottacin, Wallace Entringer; Júnior, Edson Hipólito; Pontarolo, Roberto; Correr, Cassyano Januário

    The aim of this study was to analyze the implementation of an active methodology in a blended model of education in the teaching-learning processes of students enrolled in two disciplines: Pharmaceutical Care I and Pharmaceutical Care II, both part of the undergraduate Bachelor of Pharmacy program at the Federal University of Paraná. The study design was quasi-experimental, prospective, comparative, following a pre/posttest format, where Pharmaceutical Care classes were the intervention. Identical pre- and post-intervention tests were designed based on Anderson and Krathwohl's (2001) revision of Bloom's taxonomy, and according to the three levels of the cognitive domain: remember and understand; apply and analyze; evaluate and create. Participants were 133 students enrolled in the two Pharmaceutical Care classes. A significant difference between pre- and posttest results was observed, showing an increase in students' performance in the applied tests at all cognitive levels. This is the first study of its kind involving Pharmaceutical Care and Blended Learning. By comparing the results of the diagnostic and summative assessments based on Bloom's taxonomy at all levels of the cognitive domain, positive results were observed regarding the students' performance in the two disciplines (Pharmaceutical Care I and II). Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Electrochemical biosensors in pharmaceutical analysis

    OpenAIRE

    Gil, Eric de Souza; Melo, Giselle Rodrigues de

    2010-01-01

    Given the increasing demand for practical and low-cost analytical techniques, biosensors have attracted attention for use in the quality analysis of drugs, medicines, and other analytes of interest in the pharmaceutical area. Biosensors allow quantification not only of the active component in pharmaceutical formulations, but also the analysis of degradation products and metabolites in biological fluids. Thus, this article presents a brief review of biosensor use in pharmaceutical analysis, fo...

  14. Pharmaceuticals labelled with stable isotopes

    International Nuclear Information System (INIS)

    Krumbiegel, P.

    1986-11-01

    The relatively new field of pharmaceuticals labelled with stable isotopes is reviewed. Scientific, juridical, and ethical questions are discussed concerning the application of these pharmaceuticals in human medicine. 13 C, 15 N, and 2 H are the stable isotopes mainly utilized in metabolic function tests. Methodical contributions are given to the application of 2 H, 13 C, and 15 N pharmaceuticals showing new aspects and different states of development in the field under discussion. (author)

  15. Combating corruption in the pharmaceutical arena.

    Science.gov (United States)

    Lexchin, Joel; Kohler, Jillian Clare; Gagnon, Marc André; Crombie, James; Thacker, Paul; Shnier, Adrienne

    2018-03-15

    Corruption in healthcare generally and specifically in the pharmaceutical arena has recently been highlighted in reports by Transparency International. This article focuses on four areas of corruption: legislative/regulatory, financial, ideological/ethical, and communications. The problems identified and the solutions considered focus on structural considerations affecting how pharmaceuticals are discovered, developed, distributed, and ultimately used in clinical settings. These include recourse to user fees in the regulatory sphere, application of intellectual property rights to medical contexts (patents and access to research data), commercial sponsorship of ghost writing and guest authors, linkage/delinkage of the funding of research and overall health objectives to/from drug pricing and sales, transparency of payments to healthcare professionals and institutions, and credible regulatory sanctions. In general, financial and other incentives for all actors in the system should be structured to align with desired social outcomes - and to minimise conflicts of interest among researchers and clinicians.

  16. Energy policy and federalism

    Energy Technology Data Exchange (ETDEWEB)

    Thur, L M [ed.

    1981-04-01

    Separate abstracts are prepared for six papers presented as the product of an international seminar on Energy Policy and Federalism in North America. Specially commissioned papers for the seminar are presented along with a summary of the discussions. The summary appears in English, French, and Spanish; the other papers are in English. (MCW)

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

    Science.gov (United States)

    Hiyama, Yukio

    2010-01-01

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

  18. Does the new International Diabetes Federation definition of metabolic syndrome improve prediction of coronary artery disease and carotid intima-media thickening?

    Science.gov (United States)

    Timóteo, Ana; Santos, Rui; Lima, Sandra; Mamede, Andreia; Fernandes, Rita; Ferreira, Rui

    2009-02-01

    Metabolic syndrome (MS) is associated with increased incidence of diabetes and atherosclerotic complications. The new definition of the International Diabetes Federation (IDF) increases the population with this entity, compared to the NCEP ATP III definition. To study the prevalence of coronary artery disease (CAD) and carotid intima-media thickness (IMT) in patients with and without MS, according to the NCEP ATP III and IDF definitions, and the predictive ability of carotid IMT for CAD. We studied 270 consecutive patients admitted for elective coronary angiography due to suspicion of CAD. All patients underwent ultrasound study of the carotid arteries to measure IMT (the highest value between the right and left common carotid arteries was used in the analysis). Coronary stenosis of > or =70% (or 50% for the left main coronary artery) was considered significant. By the ATP III definition, 14% of the patients had MS, and these patients had a higher prevalence of CAD (87% vs. 63%, p = 0.004), but no significant difference was found for carotid IMT (1.03 +/- 0.36 mm vs. 0.95 +/- 0.35 mm, p=NS). With the IDF definition, 61% of the patients had MS; this group was slightly older and included more women. There were no differences in terms of CAD (68% vs. 63%) or carotid IMT (0.97 +/- 0.34 vs. 0.96 +/- 0.39 mm). On multivariate analysis, the ATP III definition of MS predicts CAD (OR 4.76, 95% CI 1.71-13.25, p = 0.003), but the IDF definition does not (OR 1.29, 95% CI 0.74-2.27, p = 0.37). On ROC curve analysis, an IMT of > or = 0.95 mm predicts CAD (AUC 0.66, p definition increases the population with MS, decreasing the capacity to predict the presence of CAD. In our population, neither the ATP III nor the IDF definition showed differences in terms of carotid IMT. Carotid IMT can predict CAD, but with only modest sensitivity.

  19. Agreement of 13 December 1991 between the Republic of Argentina, the Federative Republic of Brazil, the Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials and the International Atomic Energy Agency for the Application of Safeguards

    International Nuclear Information System (INIS)

    1994-03-01

    The text of the Agreement (and the Protocol thereto) between the Republic of Argentina, the Federative Republic of Brazil, the Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials and the International Atomic Energy Agency for the Application of Safeguards is reproduced in this document for the information of all Members. The Agreement was approved by the Agency's Board of Governors on 7 December 1991 and signed in Vienna on 13 December 1991

  20. Effects of soil properties on the uptake of pharmaceuticals into earthworms

    International Nuclear Information System (INIS)

    Carter, Laura J.; Ryan, Jim J.; Boxall, Alistair B.A.

    2016-01-01

    Pharmaceuticals can enter the soil environment when animal slurries and sewage sludge are applied to land as a fertiliser or during irrigation with contaminated water. These pharmaceuticals may then be taken up by soil organisms possibly resulting in toxic effects and/or exposure of organisms higher up the food chain. This study investigated the influence of soil properties on the uptake and depuration of pharmaceuticals (carbamazepine, diclofenac, fluoxetine and orlistat) in the earthworm Eisenia fetida. The uptake and accumulation of pharmaceuticals into E. fetida changed depending on soil type. Orlistat exhibited the highest pore water based bioconcentration factors (BCFs) and displayed the largest differences between soil types with BCFs ranging between 30.5 and 115.9. For carbamazepine, diclofenac and fluoxetine BCFs ranged between 1.1 and 1.6, 7.0 and 69.6 and 14.1 and 20.4 respectively. Additional analysis demonstrated that in certain treatments the presence of these chemicals in the soil matrices changed the soil pH over time, with a statistically significant pH difference to control samples. The internal pH of E. fetida also changed as a result of incubation in pharmaceutically spiked soil, in comparison to the control earthworms. These results demonstrate that a combination of soil properties and pharmaceutical physico-chemical properties are important in terms of predicting pharmaceutical uptake in terrestrial systems and that pharmaceuticals can modify soil and internal earthworm chemistry which may hold wider implications for risk assessment. - Highlights: • Uptake of pharmaceuticals into earthworms is influenced by soil parameters. • Presence of pharmaceuticals in the terrestrial environment influences soil pH. • Uptake of pharmaceuticals by earthworms changes internal earthworm pH. - The uptake of pharmaceuticals into soil invertebrates is dependent on the complex interplay between pharmaceutical physico-chemical properties and soil

  1. Federal Lands

    Data.gov (United States)

    Department of Homeland Security — This map layer consists of federally owned or administered lands of theUnited States, Puerto Rico, and the U.S. Virgin Islands. Only areas of 640 acres or more are...

  2. NMR imaging and pharmaceutical sciences

    International Nuclear Information System (INIS)

    Beall, P.T.; Good, W.R.

    1986-01-01

    Described is the technique of NMR-imaging in diagnostic medicine. Proton and phosphorus NMR in diagnosis of abnormal tissue pathology. Discussed is the value of NMR to the pharmaceutical sciences. NMR may play an important role in monitoring the response of tissues to drugs, determining the localization of drugs, performing real time pharmacokinetics and testing the use of NMR contrast pharmaceuticals

  3. 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...

  4. WHO expert committee on specifications for pharmaceutical preparations.

    Science.gov (United States)

    2013-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Release procedure for International Chemical Reference Substances; WHO guidelines on quality risk management; WHO guidelines on variations to a prequalified product; and the Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products.

  5. 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

  6. Horizon Scanning for Pharmaceuticals

    DEFF Research Database (Denmark)

    Lepage-Nefkens, Isabelle; Douw, Karla; Mantjes, GertJan

    for a joint horizon scanning system (HSS).  We propose to create a central “horizon scanning unit” to perform the joint HS activities (a newly established unit, an existing HS unit, or a third party commissioned and financed by the collaborating countries). The unit will be responsible for the identification...... and filtration of new and emerging pharmaceutical products. It will maintain and update the HS database, organise company pipeline meetings, and disseminate the HSS’s outputs.  The HS unit works closely together with the designated national HS experts in each collaborating country. The national HS experts...... will collect country-specific information, liaise between the central HS unit and country-specific clinical and other experts, coordinate the national prioritization process (to select products for early assessment), and communicate the output of the HSS to national decision makers.  The outputs of the joint...

  7. Packaging and labeling of pharmaceutical products obtained from the internet.

    Science.gov (United States)

    Veronin, Michael

    2011-02-15

    For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping

  8. FEDERALISM IN ETHIOPIA AND FOREIGN RELATIONS ...

    African Journals Online (AJOL)

    milkii

    exclusive power of foreign relations by the federal government in federal polity confronts ..... vi) Participation of regional authorities in the international events ... stipulated that, the tiers of government are independent and one should respect.

  9. Pharmaceutical advertising in emergency departments.

    Science.gov (United States)

    Marco, Catherine A

    2004-04-01

    Promotion of prescription drugs represents a growing source of pharmaceutical marketing expenditures. This study was undertaken to identify the frequency of items containing pharmaceutical advertising in clinical emergency departments (EDs). In this observational study, emergency physician on-site investigators quantified a variety of items containing pharmaceutical advertising present at specified representative times and days, in clinical EDs. Measurements were obtained by 65 on-site investigators, representing 22 states. Most EDs in this study were community EDs (87% community and 14% university or university affiliate), and most were in urban settings (50% urban, 38% suburban, and 13% rural). Investigators measured 42 items per ED (mean = 42; median = 31; interquartile range of 14-55) containing pharmaceutical advertising in the clinical area. The most commonly observed items included pens (mean 15 per ED; median 10), product brochures (mean 5; median 3), stethoscope labels (mean 4; median 2), drug samples (mean 3; median 0), books (mean 3.4), mugs (mean 2.4), and published literature (mean 3.1). EDs with a policy restricting pharmaceutical representatives in the ED had significantly fewer items containing pharmaceutical advertising (median 7.5; 95% CI = 0 to 27) than EDs without such a policy (median 35; 95% CI = 27 to 47, p = 0.005, nonparametric Wilcoxon two-sample test). There were no differences in quantities of pharmaceutical advertising for EDs in community compared with university settings (p = 0.5), rural compared with urban settings (p = 0.3), or annual ED volumes (p = 0.9). Numerous items containing pharmaceutical advertising are frequently observed in EDs. Policies restricting pharmaceutical representatives in the ED are associated with reduced pharmaceutical advertising.

  10. THE STUDY FOR REGIONAL RETAIL PHARMACEUTICAL MARKET

    Directory of Open Access Journals (Sweden)

    O. V. Sokolova

    2015-01-01

    Full Text Available Pharmacy organizations are an element of regional pharmaceutical market infrastructure formation. They have different character and activity type, organizational and legal forms, types of properties. The revelation of the features of retail pharmaceutical market of Yaroslavl oblast was the purpose of the study. The analysis of the data of regional department of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation  n Yaroslavl oblast in the beginning of 2014 showed that there are 137 acting commercial entities, which have licenses for pharmaceutical activity. The region has 487  pharmacy organizations which implement pharmaceutical activity of state (14.6%, municipal (7.4%, and private (78.0% forms of ownership. Some companies function in Yaroslavl (43.9% and Rybinsk (22.4% municipal district. The analysis of organization and legal forms revealed that 48.9% of pharmacy organizations are registered as ltd, 14.6% are state, and 14.2% are private entrepreneurs, public limited companies amount to 10.9%, the rest pharmacy organizations are included into municipal unitary enterprises and private limited companies – 7.39% and 4.1% correspondingly. The structure of retail market is represented by single pharmacy organizations (51.1% as well as organizations joined into pharmacy chains from two and more PO (48.9%. The share of commercial entities which include one PO amounted to 14.4% of all PO. Share of pharmacy chains (42.3% which include from 2 to 9 PO are 46.8% of all PO. Pharmacy chains, which have more than 9 retails spots amount to 6.6% of the total number of commercial entities. 38.8% of PO function within them. Pharmacy chains prevalence (42.3%, joined into 9 PO; pharmacy chains, which have more than 9 PO, and include state sector PO (14.6% are the features of the regional market.

  11. International

    International Nuclear Information System (INIS)

    Anon.

    1997-01-01

    This rubric reports on 10 short notes about international economical facts about nuclear power: Electricite de France (EdF) and its assistance and management contracts with Eastern Europe countries (Poland, Hungary, Bulgaria); Transnuclear Inc. company (a 100% Cogema daughter company) acquired the US Vectra Technologies company; the construction of the Khumo nuclear power plant in Northern Korea plays in favour of the reconciliation between Northern and Southern Korea; the delivery of two VVER 1000 Russian reactors to China; the enforcement of the cooperation agreement between Euratom and Argentina; Japan requested for the financing of a Russian fast breeder reactor; Russia has planned to sell a floating barge-type nuclear power plant to Indonesia; the control of the Swedish reactor vessels of Sydkraft AB company committed to Tractebel (Belgium); the renewal of the nuclear cooperation agreement between Swiss and USA; the call for bids from the Turkish TEAS electric power company for the building of the Akkuyu nuclear power plant answered by three candidates: Atomic Energy of Canada Limited (AECL), Westinghouse (US) and the French-German NPI company. (J.S.)

  12. [Pharmaceutical logistic in turnover of pharmaceutical products of Azerbaijan].

    Science.gov (United States)

    Dzhalilova, K I

    2009-11-01

    Development of pharmaceutical logistic system model promotes optimal strategy for pharmaceutical functioning. The goal of such systems is organization of pharmaceutical product's turnover in required quantity and assortment, at preset time and place, at a highest possible degree of consumption readiness with minimal expenses and qualitative service. Organization of the optimal turnover chain in the region is offered to start from approximate classification of medicaments by logistic characteristics. Supplier selection was performed by evaluation of timeliness of delivery, quality of delivered products (according to the minimum acceptable level of quality) and time-keeping of time spending for orders delivery.

  13. Corporate social responsibility: A pharmaceutical analysis

    Directory of Open Access Journals (Sweden)

    D. J. Theron

    2005-12-01

    Full Text Available In the modern business environment organisations need to address two important aspects affecting their operations: the quality of management and the impact of their operations on the well-being of the society in which they operate. This dualism often results in economic, political and social dilemmas influencing the viability of organisations in general, and more specifically and recently, local and international pharmaceutical organisations operating in South Africa. This article considers the aspect of corporate social responsibility (CSR in general and attempts to identify the social-related issues impacting on the pharmaceutical industry by means of content analysis - a research technique for making replicable and valid inferences from data. It furthermore describes the re-action of pharmaceutical organisations when confronted with such social demands, and finally analyses the management of CSR against four criteria of CSR. The article confirms the importance of managers to manage CSR towards society in a proactive manner. It furthermore suggests that the "hard" factors of strategic management and financial performance should be balanced with "soft" social/people issues. It also recommends that the industry should consider - and if applicable - endorse the concept of Issues Management as an approach to the proactive management of CSR.

  14. CHART OF ACCOUNTS OF THE RUSSIAN FEDERATION SHOULD BE DETAILED WITH REFORMING OF AN ACCOUNTING REPORTING ON THE BASIS OF THE INTERNATIONAL FINANCIAL REPORTING STANDARDS (IFRS

    Directory of Open Access Journals (Sweden)

    Gegetsik A. Tovmasyan

    2013-01-01

    Full Text Available The article deals with the problem related to information base of accounting (financial reporting, which depends on conducting accounting and creation of detailed classification of chart of accounts of the Russian Federation. It is offered to change the structure of the balance sheet and the report on changes of the capital in the Russian Federation with introduction of “paid-in capital” indicator which not only unifies the reporting according to IFRS, but also will allow objectively estimating and predicting results and risks of both business activity and investment activity.

  15. [Hospital pharmaceutical practice in prison].

    Science.gov (United States)

    Harcouët, L

    2010-09-01

    Since 1994, hospital pharmaceutical teams have been in charge of pharmaceutical tasks in "unités de consultation et de soins ambulatoires" (UCSA), which are hospital consulting care units in French prisons. In 2008, pharmaceutical team in Parisian prisons received 6500 prescriptions and prepared 85,000 nominative bags containing drugs. Prisoners were 1.3% to receive treatments against HIV, 8.2% cardiovascular drugs, 7.2% opioid substitution treatments, and 52.9% psychoactive drugs, including 39.3% hypnotics, 40.5% anxiolytics, 11.3% antidepressants and 12.2% neuroleptics. In prison, the dichotomy between somatic and mental care is marked, attitudes of prisoners about their medicines are complex (important claims, embezzlement, etc.) and it is difficult for law defendants to maintain treatment confidentiality and to prepare prison outing in terms of health. To attenuate the heterogeneity of drug distribution systems in French prisons, we propose pharmaceutical analysis of prescriptions and nominative dispensation, computerization in UCSA in coordination with hospitals, a better contribution of prison medical and pharmaceutical staff in hospital "drug committees" and the redaction of pharmaceutical guidelines. Acting in concert with multidisciplinary medical staff in UCSA, pharmaceutical teams have to develop epidemiological studies to improve knowledge in prisoner's health and also prevention and health care in prison. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

  16. 76 FR 37129 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2011-06-24

    ... sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations... Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of... recent years, many important initiatives have been undertaken by regulatory authorities and industry...

  17. 76 FR 49773 - International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or...

    Science.gov (United States)

    2011-08-11

    ... sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations... Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of..., many important initiatives have been undertaken by regulatory authorities and industry associations to...

  18. 75 FR 17147 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2010-04-05

    ... sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations... Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of... recent years, many important initiatives have been undertaken by regulatory authorities and industry...

  19. 75 FR 18509 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2010-04-12

    ... sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations... Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of... recent years, many important initiatives have been undertaken by regulatory authorities and industry...

  20. Energetic Materials - Technology, Manufacturing and Processing, 27th International Annual Conference of ICT June 25 - June 28, 1996 Karisruhe, Federal Republic of Germany

    National Research Council Canada - National Science Library

    1997-01-01

    .... The 27th International ICT Annual Conference centers at the discussion of the art in research and development of modern rocket propellants, explosives, gun propellants and pyrotechnics emphasizing...

  1. Biricodar. Vertex Pharmaceuticals.

    Science.gov (United States)

    Dey, Saibal

    2002-05-01

    Vertex is developing biricodar as a chemosensitizing agent designed to restore the effectiveness of chemotherapeutic agents in tumor multidrug resistance. By November 1998, phase II trials had commenced for biricodar, in combination with chemotherapy, for five common cancer indications: breast, ovarian, soft-tissue sarcomas, small cell lung cancer and prostate cancer. Phase II trials were ongoing in January 2002. By March 2000, Vertex was the sole developer of biricodar, as an agreement made in 1996 with BioChem Pharma (now Shire Pharmaceuticals), for the development and marketing of biricodar in Canada was terminated. Biricodar is the free base compound, which also has a citrate salt analog known as VX-710-3. Vertex has published three patents, WO-09615101, WO-09636630 and WO-09736869, disclosing derivatives of biricodar that are claimed for the treatment of multidrug resistant protein and P-glycoprotein-mediated multidrug resistant tumors. In January 2002, a Banc of America analyst report forecast that biricodar had a 30% chance of reaching the market with a launch date in the second half of 2005, with peak sales estimated at $250 million.

  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. Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety.

    Science.gov (United States)

    de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

    2018-01-01

    Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical

  4. Creeping Federalization

    DEFF Research Database (Denmark)

    Sweeney, Richard J.

    2003-01-01

    that make taxharmonization difficult to impose. Other types of harmonization have a less clear-cut costbenefitanalysis. A federal commercial code that is uniform across member states reducestransaction and information costs, compared to leaving important code issues to memberstates; further, many states may...

  5. Characterization of the evolution of the pharmaceutical regulatory environment.

    Science.gov (United States)

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

    2013-01-01

    This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main

  6. Recognizing misleading pharmaceutical marketing online.

    Science.gov (United States)

    De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

    2014-01-01

    In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. © 2014 American Academy of Psychiatry and the Law.

  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. in Leafy Vegetable and Pharmaceutical

    African Journals Online (AJOL)

    Bheema

    successfully employed for the determination of copper (II) in leafy vegetable and pharmaceutical samples. ... Our previous studies of transition metal ions such as zinc, cobalt and ..... A new method for extractive photometric determination of.

  9. Tropical Journal of Pharmaceutical Research

    African Journals Online (AJOL)

    Tropical Journal of Pharmaceutical Research. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 12, No 6 (2013) >. Log in or Register to get access to full text downloads.

  10. Nanocrystals Technology for Pharmaceutical Science.

    Science.gov (United States)

    Cheng, Zhongyao; Lian, Yumei; Kamal, Zul; Ma, Xin; Chen, Jianjun; Zhou, Xinbo; Su, Jing; Qiu, Mingfeng

    2018-05-17

    Nanocrystals technology is a promising method for improving the dissolution rate and enhancing the bioavailability of poorly soluble drugs. In recent years, it has been developing rapidly and applied to drug research and engineering. Nanocrystal drugs can be formulated into various dosage forms. This review mainly focused on the nanocrystals technology and its application in pharmaceutical science. Firstly, different preparation methods of nanocrystal technology and the characterization of nanocrystal drugs are briefly described. Secondly, the application of nanocrystals technology in pharmaceutical science is mainly discussed followed by the introduction of sustained release formulations. Then, the scaling up process, marketed nanocrystal drug products and regulatory aspects about nanodrugs are summarized. Finally, the specific challenges and opportunities of nanocrystals technology for pharmaceutical science are summarized and discussed. This review will provide a comprehensive guide for scientists and engineers in the field of pharmaceutical science and biochemical engineering. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  11. Salvia officinalis used in pharmaceutics

    Science.gov (United States)

    Lemle, K. L.

    2018-01-01

    The paper presents some pharmaceutical properties of Salvia officinalis, a plant belonging the Lamiaceae family, one of the oldest medicinal plants, which play an important role in improving the state of health.

  12. Tropical Journal of Pharmaceutical Research

    African Journals Online (AJOL)

    We seek to encourage pharmaceutical and allied research of tropical and ... and related disciplines (including biotechnology, cell and molecular biology, drug ... with ibrutinib reduces proliferation, migration and invasion of lung cancer cells ...

  13. PARTICULARITIES OF MODERN PHARMACEUTICAL PROMOTION

    Directory of Open Access Journals (Sweden)

    Юрий Владимирович Тарасов

    2014-02-01

    Full Text Available Pharmaceutical products market is one of the most saturated consumers’ markets. Characteristic features of it are: high competition, fierce struggle for the customer, specific technologies of promotion. In conditions of globalization and increase in competition both in world pharmaceutical market and in the market of medicines and goods of medical purpose in Russia modern marketing techniques of promotion of the products to the end consumers are the key tools for strengthening market positions – both of producers of pharmaceutical goods and their suppliers, distributors, big whole-sale companies. Among main tools of promotion are: advertising, public relations, stimulation of sales on the market of medicines, personal sales, computer technologies. The article describes different technologies of promotion of medicines: indoor-advertising, hot lines, pharmaceutical exhibitions, packing. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-1

  14. 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

  15. Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints

    OpenAIRE

    Kesselheim, Aaron S.; Mello, Michelle M.; Studdert, David M.

    2011-01-01

    Editors' Summary Background Before a pharmaceutical company can market a new prescription drug in the US, the drug has to go through a long approval process. After extensive studies in the laboratory and in animals, the pharmaceutical company must test the drug's safety and efficacy in a series of clinical trials in which groups of patients with specific diseases are given the drug according to strict protocols. The results of these trials are reviewed by Federal Drug Administration (FDA, the...

  16. 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.

  17. Federal research policy 1988

    International Nuclear Information System (INIS)

    1988-01-01

    The report covers several separate parts dealing with the following: Orientation and perspectives of the Federal Government's research policy; resources available for science, research and development; fields of main interest in R and D work sponsored by the Government; research and technology policy of the Lands; international and national research and technology policy; organisations promoting and establishment doing research work in the FRG; statistics. The guidelines and principles of research policy are given: freedom of science and research; restraint from governmental influence within the meaning of the subsidiarity principle; positive attitude to scientific and technical progress; investigation of long-term perspectives and options; fostering joint responsibility of the Federal Government and the Lands; development of international cooperation. (orig./HSCH) [de

  18. Provisional Measures in the Case Concerning Application of the International Convention on the Elimination of All Forms of Racial Discrimination (Georgia v. Russian Federation

    Directory of Open Access Journals (Sweden)

    Tobias Thienel

    2009-02-01

    , to facilitate humanitarian assistance, and to generally refrain from any action which might prejudice the rights under adjudication in the case. The Order of the Court was made by a vote of eight to seven, and gave rise to a Joint Dissenting Opinion by seven judges. Those judges expressed not only their dissent from the making of the Order, but also their disagreement with the majority’s finding of even prima facie jurisdiction.[3]

    The case has already raised a few interesting issues relating to the Court’s jurisdiction to indicate provisional measures, and to the interpretation of CERD. These issues were all hotly contested not only between the parties, but also between the judges of the ICJ. This note will give a brief overview of the decision of the Court, and will comment on some outstanding features of the different opinions expressed.


    [1]        Application of the International Convention on the Elimination of All Forms of Racial Discrimination (Georgia v. Russian Federation, Order of 15 October 2008 (Georgia v. Russia, available at http://www.icj-cij.org/docket/files/140/14801.pdf (last visited 10

  19. 76 FR 42625 - International Settlements Policy Reform

    Science.gov (United States)

    2011-07-19

    ...] International Settlements Policy Reform AGENCY: Federal Communications Commission. ACTION: Notice of proposed rulemaking. SUMMARY: The Federal Communications Commission proposes to remove the International Settlements... proposes to remove the International Settlements Policy (ISP) from all U.S. international routes except...

  20. Federal databases

    International Nuclear Information System (INIS)

    Welch, M.J.; Welles, B.W.

    1988-01-01

    Accident statistics on all modes of transportation are available as risk assessment analytical tools through several federal agencies. This paper reports on the examination of the accident databases by personal contact with the federal staff responsible for administration of the database programs. This activity, sponsored by the Department of Energy through Sandia National Laboratories, is an overview of the national accident data on highway, rail, air, and marine shipping. For each mode, the definition or reporting requirements of an accident are determined and the method of entering the accident data into the database is established. Availability of the database to others, ease of access, costs, and who to contact were prime questions to each of the database program managers. Additionally, how the agency uses the accident data was of major interest

  1. Aerial Photography and Imagery, Ortho-Corrected, This imagery was acquired through a Federal Grant with Pictometry International. The resolution is 6" in more densly populated areas and 1' in the other areas., Published in 2011, Not Applicable scale, Chippewa County Government.

    Data.gov (United States)

    NSGIC Local Govt | GIS Inventory — Aerial Photography and Imagery, Ortho-Corrected dataset current as of 2011. This imagery was acquired through a Federal Grant with Pictometry International. The...

  2. Russian Federation

    International Nuclear Information System (INIS)

    2001-01-01

    In the Russian Federation (RF), management of radioactive wastes will be carried out within the framework of the Federal Target Program for management of radioactive wastes and used nuclear materials for the period 1996-2005. The agency within the RF responsible for this program is the Ministry of Russian Federation on Atomic Energy. Current radioactive waste disposal activities are focused on creating regional repositories for wastes generated by radiochemical production, nuclear reactors, science centers, and from other sources outside of the nuclear-fuel cycle (the latter wastes are managed by Scientific and Industrial Association, 'RADON'). Wastes of these types are in temporary storage, with the exception of non-fuel cycle wastes which are in long term storage managed by SAI 'RADON'. The criteria for segregating between underground or near-surface disposal of radioactive waste are based on the radiation fields and radionuclide composition of the wastes. The most progress in creating regional repositories has been made in the Northwest region of Russia. However, development of a detailed design has begun for a test facility in the Northeast for disposal of radioactive wastes generated in Murmansk and Arkhangelsk provinces. The feasibility study for construction of this facility is being evaluated by state monitoring organizations, the heads of administrations of the Arkhangelsk and Murmansk provinces, and Minatom of Russia

  3. The pharmaceutical death-ride of dihydroartemisinin.

    Science.gov (United States)

    Jansen, Frans Herwig

    2010-07-22

    In the 2010 second edition of WHO's guidelines for the treatment of malaria, the relatively new fixed dose combination dihydroartemisinin-piperaquine is included as one of the recommended artemisinin combination therapies. However, experimental testing demonstrates that, due to its intrinsic chemical instability, dihydroartemisinin is not suitable to be used in pharmaceutical formulations. In addition, data show that the currently available dihydroartemisinin preparations fail to meet the internationally accepted stability requirements. At a time when many efforts aim to ban counterfeit and substandard drugs from the malaria market, the obvious question rises how WHO and public-private partnerships, such as Medicine for Malaria venture (MMV), can support the production and marketing of anti-malarial drugs that do not even meet the International Pharmacopoeia requirements?

  4. The pharmaceutical death-ride of dihydroartemisinin

    Directory of Open Access Journals (Sweden)

    Jansen Frans

    2010-07-01

    Full Text Available Abstract In the 2010 second edition of WHO's guidelines for the treatment of malaria, the relatively new fixed dose combination dihydroartemisinin-piperaquine is included as one of the recommended artemisinin combination therapies. However, experimental testing demonstrates that, due to its intrinsic chemical instability, dihydroartemisinin is not suitable to be used in pharmaceutical formulations. In addition, data show that the currently available dihydroartemisinin preparations fail to meet the internationally accepted stability requirements. At a time when many efforts aim to ban counterfeit and substandard drugs from the malaria market, the obvious question rises how WHO and public-private partnerships, such as Medicine for Malaria venture (MMV, can support the production and marketing of anti-malarial drugs that do not even meet the International Pharmacopoeia requirements?

  5. The supply of pharmaceuticals in humanitarian assistance missions: implications for military operations.

    Science.gov (United States)

    Mahmood, Maysaa; Riley, Kevin; Bennett, David; Anderson, Warner

    2011-08-01

    In this article, we provide an overview of key international guidelines governing the supply of pharmaceuticals during disasters and complex emergencies. We review the World Health Organization's guidelines on pharmaceutical supply chain management and highlight their relevance for military humanitarian assistance missions. Given the important role of pharmaceuticals in addressing population health needs during humanitarian emergencies, a good understanding of how pharmaceuticals are supplied at the local level in different countries can help military health personnel identify the most appropriate supply options. Familiarity with international guidelines involved in cross-border movement of pharmaceuticals can improve the ability of military personnel to communicate more effectively with other actors involved in humanitarian and development spheres. Enhancing the knowledge base available to military personnel in terms of existing supply models and funding procedures can improve the effectiveness of humanitarian military operations and invite policy changes necessary to establish more flexible acquisition and funding regulations.

  6. Pharmaceutical supply chain risk assessment in Iran using analytic hierarchy process (AHP) and simple additive weighting (SAW) methods.

    Science.gov (United States)

    Jaberidoost, Mona; Olfat, Laya; Hosseini, Alireza; Kebriaeezadeh, Abbas; Abdollahi, Mohammad; Alaeddini, Mahdi; Dinarvand, Rassoul

    2015-01-01

    Pharmaceutical supply chain is a significant component of the health system in supplying medicines, particularly in countries where main drugs are provided by local pharmaceutical companies. No previous studies exist assessing risks and disruptions in pharmaceutical companies while assessing the pharmaceutical supply chain. Any risks affecting the pharmaceutical companies could disrupt supply medicines and health system efficiency. The goal of this study was the risk assessment in pharmaceutical industry in Iran considering process's priority, hazard and probability of risks. The study was carried out in 4 phases; risk identification through literature review, risk identification in Iranian pharmaceutical companies through interview with experts, risk analysis through a questionnaire and consultation with experts using group analytic hierarchy process (AHP) method and rating scale (RS) and risk evaluation of simple additive weighting (SAW) method. In total, 86 main risks were identified in the pharmaceutical supply chain with perspective of pharmaceutical companies classified in 11 classes. The majority of risks described in this study were related to the financial and economic category. Also financial management was found to be the most important factor for consideration. Although pharmaceutical industry and supply chain were affected by current political conditions in Iran during the study time, but half of total risks in the pharmaceutical supply chain were found to be internal risks which could be fixed by companies, internally. Likewise, political status and related risks forced companies to focus more on financial and supply management resulting in less attention to quality management.

  7. Public Participation and the Rights of the Child: Reflection on International Law Standards in the Legal System of the Russian Federation

    OpenAIRE

    Mariya Riekkinen

    2016-01-01

    This article deals with the much debated issue of children’s public participation from the perspective of legal practices in the Russian Federation. Having emerged at the level of national jurisdictions, the practice of engaging minors in decision-making processes on issues of public significance – or the practice of public participation of children – is stipulated by the UN Committee on the Rights of the Child, based on Article 12 of the UN Convention on the Rights of the Child. Public parti...

  8. [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.

  9. Global pharmaceutical regulation: the challenge of integration for developing states.

    Science.gov (United States)

    Pezzola, Anthony; Sweet, Cassandra M

    2016-12-20

    This paper has set out to map the state of pharmaceutical regulation in the developing world through the construction of cross-national indices drawing from World Health Organization data. The last two decades have been characterized by deep changes for the pharmaceutical sector, including the complete transformation of intellectual property systems at the behest of the World Trade Organization and the consolidation of global active ingredient suppliers in China and India. Although the rules for ownership of medicine have been set and globally implemented, we know surprisingly little about how the standards for market entrance and regulation of pharmaceutical products have changed at the national level. How standardized are national pharmaceutical market systems? Do we find homogeneity or variation across the developing world? Are their patterns for understanding why some countries have moved closer to one global norm for pharmaceutical regulation and others have developed hybrid models for oversight of this sector? Access to medicine is a core tool in public health. This paper gauges the levels of standards in public and private generics markets for developing countries building on national-level pharmaceutical market surveys for 78 countries to offer three indicators of market oversight: State Regulatory Infrastructure, Monitoring the Private Market and Public Quality Control. Identifying the different variables that affect a state's institutional capacity and current standard level offers new insights to the state of pharmaceuticals in the developing world. It is notable that there are very few (none at the time of this paper) studies that map out the new global terrain for pharmaceutical regulation in the post-TRIPS context. This paper uses item response theory to develop original indicators of pharmaceutical regulation. We find remarkable resistance to the implementation of global pharmaceutical norms for quality standards in developing states and in

  10. Fiscal Federalism

    DEFF Research Database (Denmark)

    Feng, Xingyuan; Ljungwall, Christer; Guo, Sujian

    2013-01-01

    China's central–local relations have been marked by perpetual changes amidst economic restructuring. Fiscal decentralization on the expenditure side has been paralleled by centralization on the revenue side, accompanied by political centralization. Hence, our understanding of China's fiscal...... relations is not without controversy. This paper aims to make a theoretical contribution to the ongoing debate on ‘fiscal federalism’ by addressing crucial questions regarding China's central–local fiscal relations: first, to what extent do Chinese central–local fiscal relations conform to fiscal federalism...

  11. 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)

  12. Seventh meeting of the International Working Group on Gas-Cooled Reactors, Beckum, Federal Republic of Germany, 29-30 October 1987

    International Nuclear Information System (INIS)

    1988-06-01

    The document contains a summary report on the seventh meeting of the International Working Group on Gas-Cooled Reactors and 8 reports describing the national GCR programmes of Austria, China, France, Japan, Switzerland, USSR, UK and Commission of European Communities. A separate abstract was prepared for each of these reports. Refs and tabs

  13. 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...

  14. Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

    Science.gov (United States)

    Hojo, Taisuke

    2017-01-01

    Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

  15. A strategy to improve skills in pharmaceutical supply management in East Africa: the regional technical resource collaboration for pharmaceutical management

    Directory of Open Access Journals (Sweden)

    Minzi Omary

    2008-12-01

    Full Text Available Abstract Background International initiatives such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, the President's Emergency Plan for AIDS Relief and the President's Malaria Initiative have significantly increased availability and access to medicines in some parts of the developing world. Despite this, however, skills remain limited on quantifying needs for medications and ordering, receiving and storing medications appropriately; recording medications inventories accurately; distributing medications for use appropriately; and advising patients on how to use medications appropriately. The Regional Technical Resource Collaboration for Pharmaceutical Management (RTRC has been established to help address the problem of skills shortage in pharmaceutical management in East Africa. Methods The initiative brings together academic institutions from four East African countries to participate in skills-building activities in pharmaceutical supply management. The initiative targeted the institutions' ability to conduct assessments of pharmaceutical supply management systems and to develop and implement effective skills-building programmes for pharmaceutical supply chain management. Results Over a two-year period, the RTRC succeeded in conducting assessments of pharmaceutical supply management systems and practices in Kenya, Rwanda, Tanzania and Uganda. In 2006, the RTRC participated in a materials-development workshop in Kampala, Uganda, and contributed to the development of comprehensive HIV/AIDS pharmaceutical management training materials; these materials are now widely available in all four countries. In Tanzania and Uganda the RTRC has been involved with the training of health care workers in HIV/AIDS pharmaceutical management. In Kenya, Tanzania and Uganda the RTRC has been conducting operations research to find solutions to their countries' skills-shortage problems. Some of the interventions tested include applying and evaluating the

  16. Regulation of Pharmaceutical Prices

    DEFF Research Database (Denmark)

    Kaiser, Ulrich; Méndez, Susan J.; Rønde, Thomas

    2014-01-01

    Reference prices constitute a main determinant of patient health care reimbursement in many countries. We study the effects of a change from an "external" (based on a basket of prices in other countries) to an "internal" (based on comparable domestic products) reference price system. We find...... that while our estimated consumer compensating variation is small, the reform led to substantial reductions in list and reference prices as well as co-payments, and to sizeable decreases in overall producer revenues, health care expenditures, and co-payments. These effects differ markedly between branded...

  17. Regulation of Pharmaceutical Prices

    DEFF Research Database (Denmark)

    Kaiser, Ulrich; Méndez, Susan J.; Rønde, Thomas

    Reference prices constitute a main determinant of patient health care reimbursement in many countries. We study the effects of a change from an "external" (based on a basket of prices in other countries) to an "internal" (based on comparable domestic products) reference price system. We find...... that while our estimated consumer compensating variation is small, the reform led to substantial reductions in list and reference prices as well as co-payments, and to sizeable decreases in overall producer revenues, health care expenditures, and co-payments. These effects differ markedly between branded...

  18. Determinants of Pharmaceutical Industry’s Performance in Nigeria

    Directory of Open Access Journals (Sweden)

    Wakeel A. Isola

    2016-09-01

    Full Text Available This study focused on the relationships amongmarket structure, efficiency and performance of the Nigerian Pharmaceutical industry. It employed market share and operational efficiency to determine the efficiency of the industry, pre-tax return on asset to measure performance, Herfindahl- Hirschman index to measure market structure. In addition, earnings per share was used in the study as control variable. Data were obtained from the Nigerian Stock Market Factbook covering 1996 to 2010. The panel ordinary least squares technique was employed in estimating the data. Thus over the course of the study, both fixed and random effect results clearly showed that efficiency hypothesis does not hold in the case of pharmaceutical industry in Nigeria. Rather, it is shown that it is structure that determines performance. Consequently, the study recommended that necessary structures must be put in place by the Federal Ministry of Health to enhance the capacity of local pharmaceutical firms in producing the desired quality and quantity drugs needed in the country. It was also recommended that efforts should be geared towards eradicating totally the importation of fake drugs in the pharmaceutical industry.

  19. 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

  20. Acknowledgements [3. international conference on small angle neutron scattering dedicated to the 80 anniversary of Yu.M. Ostanevich, Dubna (Russian Federation), 6-9 June 2016

    International Nuclear Information System (INIS)

    2017-01-01

    The Organizers of the III International Conference on Small Angle Neutron Scattering dedicated to the 80-th anniversary of Yu. M. Ostanevich, acknowledge the financial support from the Grants of the Governmental Plenipotentiary Representatives of Romania, Slovakia, Czech Republic, scientific projects of the Cooperation Programmes JINR-Romania. Special gratitude to the JINR and FLNP administration and staff is expressed. The conference is also dedicated to the 60th Anniversary of the Joint Institute for Nuclear Research, Dubna. (paper)

  1. Pharmaceutical care in smoking cessation.

    Science.gov (United States)

    Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando

    2015-01-01

    As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre-post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation.

  2. The argument for pharmaceutical policy

    DEFF Research Database (Denmark)

    Traulsen, Janine Morgall; Almarsdóttir, Anna Birna

    2005-01-01

    and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how...

  3. Probing Pharmaceutical Mixtures during Milling

    DEFF Research Database (Denmark)

    Walker, Greg; Römann, Philipp; Poller, Bettina

    2017-01-01

    interpret the spectral changes. Overall, this study demonstrates the potential of low-frequency Raman spectroscopy, which has several practical advantages over XRPD, for probing (dis-)order during pharmaceutical processing, showcasing its potential for future development, and implementation as an in...

  4. UV imaging in pharmaceutical analysis

    DEFF Research Database (Denmark)

    Østergaard, Jesper

    2018-01-01

    UV imaging provides spatially and temporally resolved absorbance measurements, which are highly useful in pharmaceutical analysis. Commercial UV imaging instrumentation was originally developed as a detector for separation sciences, but the main use is in the area of in vitro dissolution...

  5. Archives: Tropical Journal of Pharmaceutical Research

    African Journals Online (AJOL)

    Items 1 - 50 of 97 ... Archives: Tropical Journal of Pharmaceutical Research. Journal Home > Archives: Tropical Journal of Pharmaceutical Research. Log in or Register to get access to full text downloads.

  6. 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:.

  7. Archives: Nigerian Journal of Pharmaceutical Research

    African Journals Online (AJOL)

    Items 1 - 9 of 9 ... Archives: Nigerian Journal of Pharmaceutical Research. Journal Home > Archives: Nigerian Journal of Pharmaceutical Research. Log in or Register to get access to full text downloads.

  8. Toward a Regional Research Agenda on Pharmaceutical ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    African policymakers are pushing for local pharmaceutical manufacturing as a ... Africa Development Community Pharmaceutical Business Plan (2007-2013) and ... IDRC congratulates first cohort of Women in Climate Change Science Fellows.

  9. Pharmaceutical and Medicine Manufacturing Sector (NAICS 3254)

    Science.gov (United States)

    Find environmental regulatory and compliance information for the pharmaceutical manufacturing sector, including essential uses of CFCs, NESHAP for pharmaceutical production, effluent guidelines for wastewater and management of hazardous waste.

  10. 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.

  11. Pharmaceutical care in smoking cessation

    Directory of Open Access Journals (Sweden)

    Marín Armero A

    2015-01-01

    Full Text Available Alicia Marín Armero,1 Miguel A Calleja Hernandez,2 Sabina Perez-Vicente,3 Fernando Martinez-Martinez4 1Community Pharmacy, Murcia, Spain; 2Hospital Pharmacy, University Hospital Virgen de las Nieves, Granada, Spain; 3Result Evaluation Unit, Institute of Biomedicine, Sevilla, Spain; 4Research Unit in Pharmaceutical Care, University of Granada, Granada, Spain Abstract: As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients’ access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre–post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy’s smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. Keywords: community pharmacy, health campaign, tobacco cessation, nicotine replacement therapy

  12. Pharmaceutical Advertising and Medicare Part D

    Science.gov (United States)

    Lakdawalla, Darius; Sood, Neeraj; Gu, Qian

    2013-01-01

    We explore how and to what extent prescription drug insurance expansions affects incentives for pharmaceutical advertising. When insurance expansions make markets more profitable, firms respond by boosting advertising. Theory suggests this effect will be magnified in the least competitive drug classes, where firms internalize a larger share of the benefits from advertising. Empirically, we find that the implementation of Part D coincides with a 14% to 19% increase in total advertising expenditures. This effect is indeed concentrated in the least competitive drug classes. The additional advertising raised utilization among non-elderly patients outside the Part D program by about 3.6%. This is roughly half of the direct utilization effect of Part D on elderly beneficiaries. The results suggest the presence of considerable spillover effects from publicly subsidized prescription drug insurance on the utilization and welfare of consumers outside the program. PMID:24308884

  13. Pharmaceutical advertising and Medicare Part D.

    Science.gov (United States)

    Lakdawalla, Darius; Sood, Neeraj; Gu, Qian

    2013-12-01

    We explore how and to what extent prescription drug insurance expansions affect incentives for pharmaceutical advertising. When insurance expansions make markets more profitable, firms respond by boosting advertising. Theory suggests this effect will be magnified in the least competitive drug classes, where firms internalize a larger share of the benefits from advertising. Empirically, we find that the implementation of Part D coincides with a 14-19% increase in total advertising expenditures. This effect is indeed concentrated in the least competitive drug classes. The additional advertising raised utilization among non-elderly patients outside the Part D program by about 3.6%. This is roughly half of the direct utilization effect of Part D on elderly beneficiaries. The results suggest the presence of considerable spillover effects from publicly subsidized prescription drug insurance on the utilization and welfare of consumers outside the program. Copyright © 2013 Elsevier B.V. All rights reserved.

  14. Adherence of non-pharmaceutically sponsored oncology trial protocols to the International Conference on Harmonization (ICH) guidelines in an academic institution outside the ICH jurisdictions and the impact of IRB implementation on this adherence

    International Nuclear Information System (INIS)

    Zeeneldin, A.A.

    2013-01-01

    Purpose: To assess adherence of non-pharmaceutically sponsored trials (non-PSTs) to ICH protocol structure guidelines and to estimate the effect of implementing Institutional Review Boards (IRB) review on this adherence. Methods: This is a retrospective exploratory study where 60 non-PST clinical trial protocols (CTPs) were reviewed and halved to IRB-reviewed CTPs (IRCTPs) and non-lRB-reviewed CTPs (non-lRCTPs). Adherence score (AS) was calculated as the number of fulfilled items or sub-items divided by their total number. Results: Three adherence patterns were encountered: (1) items consistently present in both groups e.g. general and background information, objectives, inclusion criteria and intervention details, (2) items consistently absent in both groups and included contact information of investigators and trial sites, product accountability, randomization codes management, interim analyses and many other statistical aspects, and (3) items variably present in both groups where the effect of IRB was verifiable. Trial site details, potential benefits, discontinuation and exclusion criteria, and follow up for adverse events were more encountered in IRCTPs than non-IRCTPs. Withdrawal criteria monitoring of treatment compliance showed a reverse pattern (p < 0.05 for all). The total AS, administrative AS and ethics AS for IRCTPs was 43%, 22% and 70% compared to 38%, 16% and 33% for non-IRCTPs (p < 0.003, <0.001, 0.004), respectively. The scientific AS was 54% for both groups (p = 0.87). Conclusions: IRB-implementation at NCl-Egypt improved ethical and administrative sections of academic protocols. However, this improvement is modest and needs further actions including adoption of protocol templates. Scientific sections were as good after IRB-implementation as they were before that

  15. Controle Interno e as Fundações de apoio à pesquisa universitária: uma análise do funcionamento do Controle Interno nas Fundações da Universidade Federal de Santa Catarina no ano de 2010 = Internal Control and foundations to support university research: a review of the functioning of internal control in the foundations of the Federal University of Santa Catarina in 2010

    Directory of Open Access Journals (Sweden)

    Natalia Kirchner Azevedo

    2010-09-01

    Full Text Available O Controle Interno tem por finalidade planejar, organizar e supervisionar informações por meio de medidas que buscam proteger o patrimônio, incrementar a eficiência operacional e promover obediência às diretrizes administrativas. Por gerenciar recursos públicos, o Controle Interno torna-se um importante órgão que atua como supervisor dos procedimentos internos. Diante disso, este artigo tem como objetivo verificar a existência e a atuação do Controle Interno nas cinco Fundações de Amparo à Pesquisa da Universidade Federal de Santa Catarina. Trata-se de um estudo descritivo, com abordagem qualitativa dos dados e fontes de coleta dos dados primária. Conclui-se que, apesar da importância do Controle Interno, apenas três Fundações apresentam um órgão de controle; constatou-se também que alguns dos procedimentos que auxiliam o desenvolvimento harmônico e possibilitam maior eficiência nas operações não são praticados em várias das Fundações analisadas, procedimentos como: plano de carreira, relatórios de desempenho, manuais internos, rotação de funcionários e segregação de funções. Os Controles Internos analisados demonstram integralizar informações entre os setores contábil, administrativo, financeiro, de pessoal e a unidade de gerenciamento de projetos. Os gestores reconhecem a importância do Controle Interno para a Fundação e são unanimes em afirmar o interesse nisso para a promoção da eficiência operacional.Internal control is designed to plan, organize and supervise information through measures that seek to protect assets, increase operational efficiency and promote adherence to administrative policies. Manage public resources for internal control becomes an important organ of internal control that acts as a supervisor of internal procedures. Thus, this study aims to verify the existence and operation of internal control in five Foundations of the Federal University of Santa Catarina. This is a

  16. Pharmaceuticals: pharmaceutical cost controls--2005. End of Year Issue Brief.

    Science.gov (United States)

    Seay, Melicia; Varma, Priya

    2005-12-31

    The enactment of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) gave states the option of offering pharmaceutical benefits within their Medicaid programs. But the law placed restrictions on states' flexibility to control what prescriptions they would cover and required the states to reimburse outpatient prescription drugs from manufacturers that signed rebate agreements with the U.S. Department of Health and Human Services. Forty-nine states--Arizona is excluded, based on its program structure--and the District of Columbia currently offer prescription drug coverage under the Medicaid Drug Rebate Program. During the past four years, states all over the country have been plagued with revenue shortfalls in their state Medicaid budgets. While the fiscal situation improved for most states in the 2004 legislative session, many states still face budget pressures in 2005. Compounding existing budget pressures are threats from the Bush Administration to shift increased costs of the Medicaid program on to the states. All things considered, the economic pressure of funding Medicaid is at the top of legislative agendas in 2005. As in previous years, states are attempting to reduce costs to their Medicaid programs by seeking savings in their pharmaceutical programs. Prescription drug costs are highly attributed as a contributing factor to the fiscal climate of state Medicaid programs. Currently, prescription drug spending outpaces that of every other category of health care and drug prices are rising faster than inflation. In response, states are instituting a variety of pharmaceutical cost control measures such as creating preferred drug lists (PDLs), negotiating supplemental rebates, forming bulk purchasing pools, promoting generic drug substitution and implementing price controls. As prescription drug cost containment tools have gained acceptance and momentum, they continue to be controversial. This issue brief explores the debate, history, methodology, utilization

  17. More Accurate Definition of Clinical Target Volume Based on the Measurement of Microscopic Extensions of the Primary Tumor Toward the Uterus Body in International Federation of Gynecology and Obstetrics Ib-IIa Squamous Cell Carcinoma of the Cervix

    Energy Technology Data Exchange (ETDEWEB)

    Xie, Wen-Jia [Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, Shantou, Guangdong Province (China); Wu, Xiao [Department of Pathology, Cancer Hospital of Shantou University Medical College, Shantou, Guangdong Province (China); Xue, Ren-Liang; Lin, Xiang-Ying [Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, Shantou, Guangdong Province (China); Kidd, Elizabeth A. [Department of Radiation Oncology, Stanford University, Stanford, California (United States); Yan, Shu-Mei [Department of Pathology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong Province (China); Zhang, Yao-Hong [Department of Radiation Oncology, Chaozhou Hospital of Chaozhou City, Guangdong Province (China); Zhai, Tian-Tian; Lu, Jia-Yang; Wu, Li-Li; Zhang, Hao [Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, Shantou, Guangdong Province (China); Huang, Hai-Hua [Department of Pathology, The Second Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong Province (China); Chen, Zhi-Jian; Li, De-Rui [Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, Shantou, Guangdong Province (China); Xie, Liang-Xi, E-mail: xieliangxi1@qq.com [Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, Shantou, Guangdong Province (China)

    2015-01-01

    Purpose: To more accurately define clinical target volume for cervical cancer radiation treatment planning by evaluating tumor microscopic extension toward the uterus body (METU) in International Federation of Gynecology and Obstetrics stage Ib-IIa squamous cell carcinoma of the cervix (SCCC). Patients and Methods: In this multicenter study, surgical resection specimens from 318 cases of stage Ib-IIa SCCC that underwent radical hysterectomy were included. Patients who had undergone preoperative chemotherapy, radiation, or both were excluded from this study. Microscopic extension of primary tumor toward the uterus body was measured. The association between other pathologic factors and METU was analyzed. Results: Microscopic extension toward the uterus body was not common, with only 12.3% of patients (39 of 318) demonstrating METU. The mean (±SD) distance of METU was 0.32 ± 1.079 mm (range, 0-10 mm). Lymphovascular space invasion was associated with METU distance and occurrence rate. A margin of 5 mm added to gross tumor would adequately cover 99.4% and 99% of the METU in the whole group and in patients with lymphovascular space invasion, respectively. Conclusion: According to our analysis of 318 SCCC specimens for METU, using a 5-mm gross tumor volume to clinical target volume margin in the direction of the uterus should be adequate for International Federation of Gynecology and Obstetrics stage Ib-IIa SCCC. Considering the discrepancy between imaging and pathologic methods in determining gross tumor volume extent, we recommend a safer 10-mm margin in the uterine direction as the standard for clinical practice when using MRI for contouring tumor volume.

  18. 76 FR 25353 - Hikma Pharmaceuticals PLC; Analysis of Agreement Containing Consent Orders To Aid Public Comment

    Science.gov (United States)

    2011-05-04

    ... FEDERAL TRADE COMMISSION [File No. 111 0051] Hikma Pharmaceuticals PLC; Analysis of Agreement...-based form. To ensure that the Commission considers an electronic comment, you must file it on the Web-based form at the Web link: https://ftcpublic.commentworks.com/ftc/hikmabaxter . If this Notice appears...

  19. The role of cocrystals in pharmaceutical science.

    Science.gov (United States)

    Shan, Ning; Zaworotko, Michael J

    2008-05-01

    Pharmaceutical cocrystals, a subset of a long known but little-studied class of compounds, represent an emerging class of crystal forms in the context of pharmaceutical science. They are attractive to pharmaceutical scientists because they can significantly diversify the number of crystal forms that exist for a particular active pharmaceutical ingredient (API), and they can lead to improvements in physical properties of clinical relevance. In this article we address pharmaceutical cocrystals from the perspective of design (crystal engineering) and present a series of case studies that demonstrate how they can enhance the solubility, bioavailability, and/or stability of API crystal forms.

  20. Influence of pharmaceutical marketing on Medicare prescriptions in the District of Columbia.

    Science.gov (United States)

    Wood, Susan F; Podrasky, Joanna; McMonagle, Meghan A; Raveendran, Janani; Bysshe, Tyler; Hogenmiller, Alycia; Fugh-Berman, Adriane

    2017-01-01

    Gifts from pharmaceutical companies are believed to influence prescribing behavior, but few studies have addressed the association between industry gifts to physicians and drug costs, prescription volume, or preference for generic drugs. Even less research addresses the effect of gifts on the prescribing behavior of nurse practitioners (NPs), physician assistants (PAs), and podiatrists. To analyze the association between gifts provided by pharmaceutical companies to individual prescribers in Washington DC and the number of prescriptions, cost of prescriptions, and proportion of branded prescriptions for each prescriber. Gifts data from the District of Columbia's (DC) AccessRx program and the federal Center for Medicare and Medicaid Services (CMS) Open Payments program were analyzed with claims data from the CMS 2013 Medicare Provider Utilization and Payment Data. Washington DC, 2013. Physicians, nurse practitioners, physician assistants, podiatrists, and other licensed Medicare Part D prescribers who participated in Medicare Part D (a Federal prescription drug program that covers patients over age 65 or who are disabled). Gifts to healthcare prescribers (including cash, meals, and ownership interests) from pharmaceutical companies. Average number of Medicare Part D claims per prescriber, number of claims per patient, cost per claim, and proportion of branded claims. In 2013, 1,122 (39.1%) of 2,873 Medicare Part D prescribers received gifts from pharmaceutical companies totaling $3.9 million in 2013. Compared to non-gift recipients, gift recipients prescribed 2.3 more claims per patient, prescribed medications costing $50 more per claim, and prescribed 7.8% more branded drugs. In six specialties (General Internal Medicine, Family Medicine, Obstetrics/Gynecology, Urology, Ophthalmology, and Dermatology), gifts were associated with a significantly increased average cost of claims. For Internal Medicine, Family Medicine, and Ophthalmology, gifts were associated with

  1. Human resource management and learning for innovation: pharmaceuticals in Mexico

    OpenAIRE

    Santiago-Rodriguez, Fernando

    2010-01-01

    This paper investigates the influence of human resource management on learning from internal and external sources of knowledge. Learning for innovation is a key ingredient of catching-up processes. The analysis builds on survey data about pharmaceutical firms in Mexico. Results show that the influence of human resource management is contingent on the knowledge flows and innovation goals pursued by the firm. Practices such as training-- particularly from external partners; and remuneration for...

  2. Phytoremediation of Pharmaceuticals - Preliminary Study

    OpenAIRE

    Kotyza, J. (Jan); Soudek, P. (Petr); Kafka, Z.; Vaněk, T. (Tomáš)

    2010-01-01

    Phytoremediation of selected pharmaceuticals (diclofenac, ibuprofen, and acetaminophen) using Armoracia rusticana and Linum usitatissimum cell cultures and by hydroponically cultivated Lupinus albus, Hordeum vulgaris, and Phragmites australis plants in laboratory conditions is described. During in vitro experiments, the best results for acetaminophen were achieved using Armoracia rusticana hairy root cultures, where 100% of the starting amount was removed from the media during eight days. To...

  3. Pharmaceutical cocrystals: walking the talk.

    Science.gov (United States)

    Bolla, Geetha; Nangia, Ashwini

    2016-06-28

    Pharmaceutical cocrystals belong to a sub-class of cocrystals wherein one of the components is a drug molecule (or an active pharmaceutical ingredient, API) and the second is a benign food or drug grade additive (generally regarded as safe, GRAS). The two components are hydrogen-bonded in a fixed stoichiometric ratio in the crystal lattice. In the past decade, pharmaceutical cocrystals have demonstrated significant promise in their ability to modify the physicochemical and pharmacokinetic properties of drug substances, such as the solubility and dissolution rate, bioavailability, particle morphology and size, tableting and compaction, melting point, physical form, biochemical and hydration stability, and permeability. In this feature review, we highlight some prominent examples of drug cocrystals which exhibit variable hardness/softness and elasticity/plasticity depending on coformer selection, improvement of solubility and permeability in the same cocrystal, increase of the melting point for solid formulation, enhanced color performance, photostability and hydration stability, and a longer half-life. Cocrystals of flavanoids and polyphenols can make improved pharmaceuticals and also extend to the larger class of nutraceuticals. The application of crystal engineering to assemble ternary cocrystals expands this field to drug-drug cocrystals which may be useful in multi-drug resistance, mitigating side effects of drugs, or attenuating/enhancing drug action synergistically by rational selection. The advent of new techniques for structural characterization beyond the standard X-ray diffraction will provide a better understanding of drug phases which are at the borderline of crystalline-amorphous nature and even newer opportunities in the future.

  4. Pharmaceutical microparticle engineering with electrospraying

    DEFF Research Database (Denmark)

    Bohr, Adam; Wan, Feng; Kristensen, Jakob

    2015-01-01

    Microparticles of Celecoxib, dispersed in a matrix of poly(lactic-co-glycolic acid) (PLGA), were prepared by electrospraying using different solvent mixtures to investigate the influence upon particle formation and the resulting particle characteristics. Mixtures consisting of a good solvent, ace...... demonstrated by the increasingly higher drug release rates. The results demonstrate the importance of solvent composition in particle preparation and indicate potential for exploiting this dependence to improve pharmaceutical particle design and performance....

  5. 15 CFR 287.4 - Responsibilities of Federal agencies.

    Science.gov (United States)

    2010-01-01

    ... assessment decision. (c) Use the results of other governmental agency and private sector organization... conducted by other Federal, state and international organizations and agencies and private sector..., the International Organization for Standardization (ISO), the International Electrotechnical...

  6. 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

  7. [E-commerce of pharmaceuticals].

    Science.gov (United States)

    Shani, Segev

    2003-05-01

    The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications.

  8. Transparency in Nigeria's public pharmaceutical sector: perceptions from policy makers

    Directory of Open Access Journals (Sweden)

    Kohler Jillian C

    2009-10-01

    Full Text Available Abstract Background Pharmaceuticals are an integral component of health care systems worldwide, thus, regulatory weaknesses in governance of the pharmaceutical system negatively impact health outcomes especially in developing countries 1. Nigeria is one of a number of countries whose pharmaceutical system has been impacted by corruption and has struggled to curtail the production and trafficking of substandard drugs. In 2001, the National Agency for Food and Drug Administration and Control (NAFDAC underwent an organizational restructuring resulting in reforms to reduce counterfeit drugs and better regulate pharmaceuticals 2. Despite these changes, there is still room for improvement. This study assessed the perceived level of transparency and potential vulnerability to corruption that exists in four essential areas of Nigeria's pharmaceutical sector: registration, procurement, inspection (divided into inspection of ports and of establishments, and distribution. Methods Standardized questionnaires were adapted from the World Health Organization assessment tool and used in semi-structured interviews with key stakeholders in the public and private pharmaceutical system. The responses to the questions were tallied and converted to scores on a numerical scale where lower scores suggested greater vulnerability to corruption and higher scores suggested lower vulnerability. Results The overall score for Nigeria's pharmaceutical system was 7.4 out of 10, indicating a system that is marginally vulnerable to corruption. The weakest links were the areas of drug registration and inspection of ports. Analysis of the qualitative results revealed that the perceived level of corruption did not always match the qualitative evidence. Conclusion Despite the many reported reforms instituted by NAFDAC, the study findings suggest that facets of the pharmaceutical system in Nigeria remain fairly vulnerable to corruption. The most glaring deficiency seems to be the

  9. Transparency in Nigeria's public pharmaceutical sector: perceptions from policy makers.

    Science.gov (United States)

    Garuba, Habibat A; Kohler, Jillian C; Huisman, Anna M

    2009-10-29

    Pharmaceuticals are an integral component of health care systems worldwide, thus, regulatory weaknesses in governance of the pharmaceutical system negatively impact health outcomes especially in developing countries 1. Nigeria is one of a number of countries whose pharmaceutical system has been impacted by corruption and has struggled to curtail the production and trafficking of substandard drugs. In 2001, the National Agency for Food and Drug Administration and Control (NAFDAC) underwent an organizational restructuring resulting in reforms to reduce counterfeit drugs and better regulate pharmaceuticals 2. Despite these changes, there is still room for improvement. This study assessed the perceived level of transparency and potential vulnerability to corruption that exists in four essential areas of Nigeria's pharmaceutical sector: registration, procurement, inspection (divided into inspection of ports and of establishments), and distribution. Standardized questionnaires were adapted from the World Health Organization assessment tool and used in semi-structured interviews with key stakeholders in the public and private pharmaceutical system. The responses to the questions were tallied and converted to scores on a numerical scale where lower scores suggested greater vulnerability to corruption and higher scores suggested lower vulnerability. The overall score for Nigeria's pharmaceutical system was 7.4 out of 10, indicating a system that is marginally vulnerable to corruption. The weakest links were the areas of drug registration and inspection of ports. Analysis of the qualitative results revealed that the perceived level of corruption did not always match the qualitative evidence. Despite the many reported reforms instituted by NAFDAC, the study findings suggest that facets of the pharmaceutical system in Nigeria remain fairly vulnerable to corruption. The most glaring deficiency seems to be the absence of conflict of interest guidelines which, if present and

  10. 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

  11. 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.

  12. Pharmaceutical product development: A quality by design approach

    Science.gov (United States)

    Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

  13. Pharmaceutical product development: A quality by design approach.

    Science.gov (United States)

    Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

  14. Recent trends in the impurity profile of pharmaceuticals

    Directory of Open Access Journals (Sweden)

    Kavita Pilaniya

    2010-01-01

    Full Text Available Various regulatory authorities such as the International Conference on Harmonization (ICH, the United States Food and Drug administration (FDA, and the Canadian Drug and Health Agency (CDHA are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredients (APIs. The various sources of impurity in pharmaceutical products are - reagents, heavy metals, ligands, catalysts, other materials like filter aids, charcoal, and the like, degraded end products obtained during \\ after manufacturing of bulk drugs from hydrolysis, photolytic cleavage, oxidative degradation, decarboxylation, enantiomeric impurity, and so on. The different pharmacopoeias such as the British Pharmacopoeia, United State Pharmacopoeia, and Indian Pharmacopoeia are slowly incorporating limits to allowable levels of impurities present in APIs or formulations. Various methods are used to isolate and characterize impurities in pharmaceuticals, such as, capillary electrophoresis, electron paramagnetic resonance, gas-liquid chromatography, gravimetric analysis, high performance liquid chromatography, solid-phase extraction methods, liquid-liquid extraction method, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction column chromatography, mass spectrometry, Nuclear magnetic resonance (NMR spectroscopy, and RAMAN spectroscopy. Among all hyphenated techniques, the most exploited techniques for impurity profiling of drugs are Liquid Chromatography (LC-Mass Spectroscopy (MS, LC-NMR, LC-NMR-MS, GC-MS, and LC-MS. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research.

  15. A validated high performance thin layer chromatography method for determination of yohimbine hydrochloride in pharmaceutical preparations

    OpenAIRE

    Jihan M Badr

    2013-01-01

    Background: Yohimbine is an indole alkaloid used as a promising therapy for erectile dysfunction. A number of methods were reported for the analysis of yohimbine in the bark or in pharmaceutical preparations. Materials and Method: In the present work, a simple and sensitive high performance thin layer chromatographic method is developed for determination of yohimbine (occurring as yohimbine hydrochloride) in pharmaceutical preparations and validated according to International Conference of Ha...

  16. Ronald Reagan's "New Federalism."

    Science.gov (United States)

    Parker, Joseph B.

    1982-01-01

    Describes how changes in federal fiscal policies affect the federal government's relationship to state and local government. Franklin D. Roosevelt's and Ronald Reagan's formulas for "New Federalism" are compared. (AM)

  17. Electrochemical biosensors in pharmaceutical analysis

    Directory of Open Access Journals (Sweden)

    Eric de Souza Gil

    2010-09-01

    Full Text Available Given the increasing demand for practical and low-cost analytical techniques, biosensors have attracted attention for use in the quality analysis of drugs, medicines, and other analytes of interest in the pharmaceutical area. Biosensors allow quantification not only of the active component in pharmaceutical formulations, but also the analysis of degradation products and metabolites in biological fluids. Thus, this article presents a brief review of biosensor use in pharmaceutical analysis, focusing on enzymatic electrochemical sensors.Em virtude do aumento da demanda por técnicas analíticas simples e de baixo custo, os biossensores têm atraído a atenção para a análise de fármacos, medicamentos e outros analitos de interesse em controle de qualidade de medicamentos. Os biossensores permitem a quantificação não somente de princípio ativo em formulações farmacêuticas, mas também de produtos de degradação e metabólitos em fluídos biológicos, bem como análise de amostras de interesse clínico e industrial, além de possibilitar a determinação de enantiômeros. Desta forma, este artigo objetiva fazer uma breve revisão a respeito do emprego de biossensores em análise farmacêutica, com ênfase em sensores eletroquímicos enzimáticos.

  18. MARIAN: Flexible Interoperability for Federated Digital Libraries

    OpenAIRE

    Goncalves, Marcos A.; France, Robert K.; Fox, Edward A.; Hilf, Eberhard R.; Zimmermann, Kerstin; Severiens, Thomas

    2001-01-01

    Federated digital libraries are composed of distributed autonomous (heterogeneous) information services but provide users with a transparent, integrated view of collected information respecting different information sources' autonomy. In this paper we discuss a federated system for the Networked Digital Library of Theses and Dissertations (NDLTD), an international consortium of universities, libraries, and other supporting institutions focused on electronic theses and dissertations (ETDs). Th...

  19. 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.

  20. [Community pharmacy and general internal medicine are at the same crossroads: some opportunities should be seized].

    Science.gov (United States)

    Bugnon, O; Buchmann, M

    2012-11-28

    The medicines give some symptoms relief and save lives every day. However, the responsible use of medicines is not definitively attained for the modern health systems. The shortcomings in this area are the cause of major negative clinical outcomes for the patients and the cause of additional cost for the health financing system. The two centenarians, as the International Pharmaceutical Federation (FIP) and the "Policlinique Médicale Universitaire (PMU)" in Lausanne, preview the solutions from now on for reversing this trend, such as the interdisciplinary collaborative approaches, the introduction of adequate financial incentives and the strengthening of education and research in community medicine, pharmacy and health.

  1. 78 FR 54680 - NASA Federal Advisory Committees

    Science.gov (United States)

    2013-09-05

    ... Committee Management Division, Office of International and Interagency Relations, NASA Headquarters... AGENCY: National Aeronautics and Space Administration. ACTION: Annual Invitation for Public Nominations... invitation for public nominations for service on NASA Federal advisory committees. U.S. citizens may nominate...

  2. Parallel Federal/State Antitrust Investigations

    OpenAIRE

    Stephen Houck

    2012-01-01

    Those matters in which both federal and state antitrust authorities do take an interest usually have significant impacts across state lines and even international borders. Stephen D. Houck (Menaker & Herrmann LLP)

  3. Tria Pharmaceuticals in the Baltics

    DEFF Research Database (Denmark)

    Kratochvil, Renate; Nell, Phillip C.

    2016-01-01

    Linda, a management consultant, had to solve a tricky problem regarding difficulties with the 'Baltic region subsidiary' of a global pharmaceutical company. She was hired by their Regional Headquarters (RHQ) for Central and Eastern Europe to disentangle this multifaceted challenge (eg sales down...... on the topic were the cultural misunderstandings between the employees of the various countries, or the company’s outdated products. Linda was challenged to, first, get a clear and comprehensive picture of the situation, and, second, propose a well-conceived solution to the RHQ. This case is written as a two...

  4. 75 FR 53973 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2010-09-02

    ... Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese... and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat... regulatory authorities and industry associations to promote international harmonization of regulatory...

  5. 75 FR 54153 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2010-09-03

    ... Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese... and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat... regulatory authorities and industry associations to promote international harmonization of regulatory...

  6. 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.

  7. Novel methodology for pharmaceutical expenditure forecast

    OpenAIRE

    Vataire, Anne-Lise; Cetinsoy, Laurent; Aball?a, Samuel; R?muzat, C?cile; Urbinati, Duccio; Kornfeld, ?sa; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    Background and objective: The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the ‘EU Pharmaceutical e...

  8. 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...

  9. 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 ...

  10. 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...

  11. Evaluation of P-Listed Pharmaceutical Residues in Empty Pharmaceutical Containers

    Science.gov (United States)

    Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have stru...

  12. 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.

  13. 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.

  14. Coming Soon to a Physician Near You: Medical Neoliberalism and Pharmaceutical Clinical Trials.

    Science.gov (United States)

    Fisher, Jill A

    2007-01-01

    This paper aims to expand standard conceptions of current ethical issues by discussing pharmaceutical clinical trials in terms of the broader political economy. Specifically, it explores one important characteristic of the political economy in the United States: the trend towards the neoliberalization of health care. First, it provides an overview of neoliberalism and its manifestations in the health care sector. Then, it applies this perspective to pharmaceutical drug development. The paper argues that federal regulation must attend to the context of clinical research to protect human subjects more fully.

  15. Comprehensive taxonomy and worldwide trends in pharmaceutical policies in relation to country income status.

    Science.gov (United States)

    Maniadakis, N; Kourlaba, G; Shen, J; Holtorf, A

    2017-05-25

    Rapidly evolving socioeconomic and technological trends make it challenging to improve access, effectiveness and efficiency in the use of pharmaceuticals. This paper identifies and systematically classifies the prevailing pharmaceutical policies worldwide in relation to a country's income status. A literature search was undertaken to identify and taxonomize prevailing policies worldwide. Countries that apply those policies and those that do not were then grouped by income status. Pharmaceutical policies are linked to a country's socioeconomics. Developed countries have universal coverage and control pharmaceuticals with external and internal price referencing systems, and indirect price-cost controls; they carry out health technology assessments and demand utilization controls. Price-volume and risk-sharing agreements are also evolving. Developing countries are underperforming in terms of coverage and they rely mostly on restrictive state controls to regulate prices and expenditure. There are significant disparities worldwide in the access to pharmaceuticals, their use, and the reimbursement of costs. The challenge in high-income countries is to maintain access to care whilst dealing with trends in technology and aging. Essential drugs should be available to all; however, many low- and middle-income countries still provide most of their population with only poor access to medicines. As economies grow, there should be greater investment in pharmaceutical care, looking to the policies of high-income countries to increase efficiency. Pharmaceutical companies could also develop special access schemes with low prices to facilitate coverage in low-income countries.

  16. Markets and Molecules: A Pharmaceutical Primer from the South.

    Science.gov (United States)

    Banerjee, Dwaipayan

    2017-01-01

    The Indian pharmaceutical industry has historically manufactured low-cost drugs for the global poor. Activist mobilizations at the height of the HIV/AIDS epidemic revealed a vast cost gap between global brands and Indian generics, much to the embarrassment of Euro-American corporations that were in the habit of pricing drugs for only the wealthy or well insured. As new drug access controversies focus on anticancer therapies, they reveal new flows of international capital, emergent genetic technologies, and increasingly coercive trade regimes. Together these favor multinational corporate oligopolies, which imperil the legacy of HIV/AIDS activism and the future availability of essential life-saving drugs for the work of global public health. In this essay, I describe how the future of the right to drug access rests uneasily, and potentially calamitously, on a shifting balance of power between global south interests and Euro-American pharmaceutical capital.

  17. Cyclodextrins and their pharmaceutical applications.

    Science.gov (United States)

    Loftsson, Thorsteinn; Duchêne, Dominique

    2007-02-01

    Cyclodextrins were first described by Villiers in 1891. Schardinger laid the foundation of the cyclodextrin chemistry in 1903-1911 and identified both alpha- and beta-cyclodextrin. In the 1930s, Freudenberg identified gamma-cyclodextrin and suggested that larger cyclodextrins could exist. Freudenberg and co-workers showed that cyclodextrins were cyclic oligosaccharides formed by glucose units and somewhat later Cramer and co-workers described their ability to form inclusion complexes. By the early 1950s the basic physicochemical characteristics of cyclodextrins had been discovered, including their ability to solubilize and stabilize drugs. The first cyclodextrin-related patent was issued in 1953 to Freudenberg, Cramer and Plieninger. However, pure cyclodextrins that were suitable for pharmaceutical applications did not come available until about 25 years later and at the same time the first cyclodextrin-containing pharmaceutical product was marketed in Japan. Later cyclodextrin-containing products appeared on the European market and in 1997 also in the US. New cyclodextrin-based technologies are constantly being developed and, thus, 100 years after their discovery cyclodextrins are still regarded as novel excipients of unexplored potential.

  18. Federal Workplace Literacy Project. Internal Evaluation Report.

    Science.gov (United States)

    Matuszak, David J.

    This report describes the following components of the Nestle Workplace Literacy Project: six job task analyses, curricula for six workplace basic skills training programs, delivery of courses using these curricula, and evaluation of the process. These six job categories were targeted for training: forklift loader/checker, BB's processing systems…

  19. Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer.

    Science.gov (United States)

    Anyakora, Chimezie; Ekwunife, Obinna; Alozie, Faith; Esuga, Mopa; Ukwuru, Jonathan; Onya, Steve; Nwokike, Jude

    2017-09-18

    Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. The cost benefit of improving the quality of Chi Pharmaceuticals Limited's facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0-5.5). Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.

  20. 18 June 2012 - DST Global Founder Y. Milner signing the guest book with Head of International Relations F. Pauss; visiting the AD facility in building 193 with AEGIS Collaboration Spokesperson M. Doser and Adviser for the Russian Federation T. Kurtyka. Managing Director I. Osborne also present with Mrs J. Milner and DST Global A. Lebedkina.

    CERN Multimedia

    Maximilien Brice

    2012-01-01

    18 June 2012 - DST Global Founder Y. Milner signing the guest book with Head of International Relations F. Pauss; visiting the AD facility in building 193 with AEGIS Collaboration Spokesperson M. Doser and Adviser for the Russian Federation T. Kurtyka. Managing Director I. Osborne also present with Mrs J. Milner and DST Global A. Lebedkina.

  1. Tuesday 28 January 2014 - K. E. Huthmacher Ministerialdirektor Provision for the Future - Basic and Sustainability Research Federal Ministry of Education and Research (BMBF) visiting the stands with R. Heuer CERN Director-General on the occasion of the Inauguration of the Industrial Exhibition Germany@CERN and visiting the ATLAS Cavern with D. Charlton ATLAS Collaboration Spokesperson and R. Voss Head of International Relations.

    CERN Multimedia

    Pantelia, Anna

    2014-01-01

    Tuesday 28 January - K. E. Huthmacher Ministerialdirektor Provision for the Future - Basic and Sustainability Research Federal Ministry of Education and Research (BMBF) visiting the stands with R. Heuer CERN Director-General on the occasion of the Inauguration of the Industrial Exhibition Germany@CERN and visiting the ATLAS Cavern with D. Charlton ATLAS Collaboration Spokesperson and R. Voss Head of International Relations.

  2. 3rd December 2010 - President Swiss Federal Institute of Technology Zürich (ETHZ)President R. Eichler signing the Guest Book with CERN Head of International Relations and ETHZ F. Pauss and visiting CMS service cavern at LHC Point 5.

    CERN Multimedia

    Maximilien Brice

    2010-01-01

    3rd December 2010 - President Swiss Federal Institute of Technology Zürich (ETHZ)President R. Eichler signing the Guest Book with CERN Head of International Relations and ETHZ F. Pauss and visiting CMS service cavern at LHC Point 5.

  3. Pharmaceutical care in Kuwait: hospital pharmacists' perspectives.

    Science.gov (United States)

    Katoue, Maram G; Awad, Abdelmoneim I; Schwinghammer, Terry L; Kombian, Samuel B

    2014-12-01

    Pharmaceutical care practice has been championed as the primary mission of the pharmacy profession, but its implementation has been suboptimal in many developing countries including Kuwait. Pharmacists must have sufficient knowledge, skills, and positive attitudes to practise pharmaceutical care, and barriers in the pharmacy practice model must be overcome before pharmaceutical care can be broadly implemented in a given healthcare system. To investigate hospital pharmacists' attitudes towards pharmaceutical care, perceptions of their preparedness to provide pharmaceutical care, and the barriers to its implementation in Kuwait. Six general hospitals, eight specialized hospitals and seven specialized health centers in Kuwait. A descriptive, cross-sectional survey was distributed to all pharmacists working in the governmental hospitals in Kuwait (385 pharmacists). Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (standard deviations) were calculated and compared using statistical package for social sciences, version 20. Statistical significance was accepted at a p value of Kuwait. Completed surveys were received from 250 (64.9%) of the 385 pharmacists. Pharmacists expressed overall positive attitudes towards pharmaceutical care. They felt well prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Pharmacists with more practice experience expressed significantly more positive attitudes towards pharmaceutical care (p = 0.001) and they felt better prepared to provide pharmaceutical care competencies (p Kuwait advocate implementation of pharmaceutical care while also appreciating the organizational, technical and professional barriers to its widespread adoption. Collaborative efforts between health authorities and educational institutions, and the integration of innovative approaches in

  4. Federated Identity Management

    OpenAIRE

    Chadwick, David W.

    2009-01-01

    Abstract. This paper addresses the topic of federated identity management. It discusses in detail the following topics: what is digital identity, what is identity management, what is federated identity management, Kim Camerons 7 Laws of Identity, how can we protect the users privacy in a federated environment, levels of assurance, some past and present federated identity management systems, and some current research in FIM.

  5. Federal Student Loan Programs

    Science.gov (United States)

    Federal Student Aid, US Department of Education, 2014

    2014-01-01

    For those needing a loan to attend college, think federal aid first. Federal student loans usually offer borrowers lower interest rates and have more flexible repayment terms and options than private student loans. This brief report answers the following questions about federal aid: (1) What is a federal student loan?; (2) What is a private…

  6. Pharmaceutical spray drying: solid-dose process technology platform for the 21st century.

    Science.gov (United States)

    Snyder, Herman E

    2012-07-01

    Requirement for precise control of solid-dosage particle properties created with a scalable process technology are continuing to expand in the pharmaceutical industry. Alternate methods of drug delivery, limited active drug substance solubility and the need to improve drug product stability under room-temperature conditions are some of the pharmaceutical applications that can benefit from spray-drying technology. Used widely for decades in other industries with production rates up to several tons per hour, pharmaceutical uses for spray drying are expanding beyond excipient production and solvent removal from crystalline material. Creation of active pharmaceutical-ingredient particles with combinations of unique target properties are now more common. This review of spray-drying technology fundamentals provides a brief perspective on the internal process 'mechanics', which combine with both the liquid and solid properties of a formulation to enable high-throughput, continuous manufacturing of precision powder properties.

  7. Synthetic biology advances for pharmaceutical production

    OpenAIRE

    Breitling, Rainer; Takano, Eriko

    2015-01-01

    Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems.

  8. Synthetic biology advances for pharmaceutical production

    Science.gov (United States)

    Breitling, Rainer; Takano, Eriko

    2015-01-01

    Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems. PMID:25744872

  9. The Impact of Biotechnology on Pharmaceutics.

    Science.gov (United States)

    Block, Lawrence H.

    1990-01-01

    The emergence of bioactive peptides and proteins as new drug species poses formidable problems for the pharmaceutical scientist. Implications for revision or change in undergraduate and graduate pharmaceutics curricula derive from the biopharmaceutical, pharmacokinetic, and physiochemical aspects of the new drug species, which differ from…

  10. 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 ...

  11. 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.

  12. National transparency assessment of Kuwait's pharmaceutical sector.

    Science.gov (United States)

    Badawi, Dalia A; Alkhamis, Yousif; Qaddoumi, Mohammad; Behbehani, Kazem

    2015-09-01

    Corruption is one of several factors that may hinder the access to pharmaceuticals. Since Kuwait has the highest per-capita spending on pharmaceuticals in the region, we wanted to evaluate the level of transparency in its pharmaceutical sector using an established assessment tool adapted by the World Health Organization. Standardized questionnaires were conducted via semi-structured interviews with key informants to measure the level of transparency in eight functions of the public pharmaceutical sector. The scores for the degree of vulnerability to corruption reflected marginal to moderate venerability to corruption for most pharmaceutical sectors. The perceived strengths included availability of appropriate laws, the presence of clear standard operating procedures, and the use of an efficient registration/distribution system. Weaknesses included lack of conflict of interest guidelines and written terms of reference, absence of pharmacoeconomic studies, and inconsistencies in law enforcement. Findings reveal that few functions of Kuwait pharmaceutical sector remain fairly vulnerable to corruption. However, the willingness of Kuwait Ministry of Health to adopt the assessment study and the acknowledgement of the weaknesses of current processes of the pharmaceutical sector may assist to achieve a transparent pharmaceutical system in the near future. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  13. 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 ...

  14. [Horus: technological innovation in pharmaceutical assistance within the Brazilian unified health system].

    Science.gov (United States)

    Costa, Karen Sarmento; Nascimento, José Miguel do

    2012-12-01

    To analyze results of the Horus Information System, comparing elements of this system with some international experiences. Horus is a technological innovation introduced in 2009 in the Pharmaceutical management information system of the Sistema Único de Saúde (Brazilian Unified Health System). In 2011, local managers and health professionals of 1,247 municipalities (16 states) that adhered to Horus answered questionnaires on pharmaceutical assistance in primary care and about the Horus system. This is a descriptive and exploratory study, developed with the use of quantitative and qualitative methods of research. Multivariate tools were used for data collection and interpretative support of the statistical inference and thematic analysis. The main changes identified after the implementation of this system were: improvement on technical and scientific quality control of Pharmaceutical Assistance, improvement on the supply of medications and health care; training of human resources and knowledge management; improvement on the relationship health managers/users; development in the administrative management and greater inter-state management; and improvement on the technological infrastructure. In terms of health information systems, these categories are consistent with programs and obstacles observed in international experiences. The biggest gap identified was the fact that Horus was not included in a national policy of health information systems, which is in a process of consolidation in Brazil. The national database of actions and services within the Pharmaceutical Assistance will enable the collection, analysis and dissemination of information regarding integrated pharmaceutical assistance in the Brazilian context. The Horus System is a technological innovation that enables the management of the Pharmaceutical Assistance. The national base will enable the definition and agreement on national indicators of Pharmaceutical Assistance, aiming to produce evidence of

  15. 75 FR 44794 - Rendezvous International v.

    Science.gov (United States)

    2010-07-29

    ... FEDERAL MARITIME COMMISSION [Docket No. 10-07] Rendezvous International v. Chief Cargo Services, Inc., Kaiser Apparel, Inc., Edco Logistics, Inc., Oriental Logistics, Inc., and Razor Enterprise... Federal Maritime Commission (``Commission'') by Rendezvous International (``Rendezvous''), hereinafter...

  16. 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

  17. Cost containment through pharmaceutical procurement: a Caribbean case study.

    Science.gov (United States)

    Huff-Rousselle, M; Burnett, F

    1996-01-01

    This article discusses the potential for health sector cost containment in developing countries through improved pharmaceutical procurement. By describing the specific example of the Eastern Caribbean Drug Service (ECDS), which provides a pooled procurement service to nine ministries of health in the small island nations of the Caribbean, it examines the elements of the procurement operation that allowed ECDS to reduce unit costs for pharmaceuticals by over 50 per cent during its first procurement cycle. The analysis of ECDS considers: (1) political will, institutional alliances, and the creation of a public sector monopsony; (2) pooling demand; (3) restricted international tendering and the pharmaceutical industry; (4) estimating demand and supplier guarantees; (5) reducing variety and increasing volume through standardizing pack sizes, dosage forms and strengths; (6) generic bidding and therapeutic alternative bidding; (7) mode of transport from foreign suppliers; (8) financing mechanisms, including choice of currency, foreign exchange, and terms of payment; (9) market conditions and crafting and enforcing supplier contracts; and, (10) the adjudication process, including consideration of suppliers' past performance, precision requirements in the manufacturing process, number of products awarded to suppliers, and issues of judgment. The authors consider the relevance of this agency's experience to other developing countries by providing a blueprint that can be adopted or modified to suit other situations.

  18. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fiftieth report.

    Science.gov (United States)

    2016-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Good pharmacopoeial practices; FIP-WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products; Guidance on good manufacturing practices for biological products; Guidance on good manufacturing practices: inspection report, including Appendix 1: Model inspection report; Guidance on good data and record management practices; Good trade and distribution practices for starting materials; Guidelines on the conduct of surveys of the quality of medicines; Collaborative procedure between the World Health Organization (WHO) prequalification team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines; Guidance for organizations performing in vivo bioequivalence studies; and World Health Organization (WHO) general guidance on variations to multisource pharmaceutical products.

  19. Stromal cells from the adipose tissue-derived stromal vascular fraction and culture expanded adipose tissue-derived stromal/stem cells: a joint statement of the International Federation for Adipose Therapeutics and Science (IFATS) and the International Society for Cellular Therapy (ISCT).

    Science.gov (United States)

    Bourin, Philippe; Bunnell, Bruce A; Casteilla, Louis; Dominici, Massimo; Katz, Adam J; March, Keith L; Redl, Heinz; Rubin, J Peter; Yoshimura, Kotaro; Gimble, Jeffrey M

    2013-06-01

    Adipose tissue is a rich and very convenient source of cells for regenerative medicine therapeutic approaches. However, a characterization of the population of adipose-derived stromal and stem cells (ASCs) with the greatest therapeutic potential remains unclear. Under the authority of International Federation of Adipose Therapeutics and International Society for Cellular Therapy, this paper sets out to establish minimal definitions of stromal cells both as uncultured stromal vascular fraction (SVF) and as an adherent stromal/stem cells population. Phenotypic and functional criteria for the identification of adipose-derived cells were drawn from the literature. In the SVF, cells are identified phenotypically by the following markers: CD45-CD235a-CD31-CD34+. Added value may be provided by both a viability marker and the following surface antigens: CD13, CD73, CD90 and CD105. The fibroblastoid colony-forming unit assay permits the evaluation of progenitor frequency in the SVF population. In culture, ASCs retain markers in common with other mesenchymal stromal/stem cells (MSCs), including CD90, CD73, CD105, and CD44 and remain negative for CD45 and CD31. They can be distinguished from bone-marrow-derived MSCs by their positivity for CD36 and negativity for CD106. The CFU-F assay is recommended to calculate population doublings capacity of ASCs. The adipocytic, chondroblastic and osteoblastic differentiation assays serve to complete the cell identification and potency assessment in conjunction with a quantitative evaluation of the differentiation either biochemically or by reverse transcription polymerase chain reaction. The goal of this paper is to provide initial guidance for the scientific community working with adipose-derived cells and to facilitate development of international standards based on reproducible parameters. Copyright © 2013 International Society for Cellular Therapy. All rights reserved.

  20. Harmonizing the definition of the metabolic syndrome: comparison of the criteria of the Adult Treatment Panel III and the International Diabetes Federation in United States American and European populations.

    Science.gov (United States)

    Assmann, Gerd; Guerra, Rudy; Fox, Garrett; Cullen, Paul; Schulte, Helmut; Willett, DuWayne; Grundy, Scott M

    2007-02-15

    The 2 most widely used criteria to diagnose the metabolic syndrome (MS) are those developed by the United States Adult Treatment Panel III of the National Cholesterol Education Program (ATP III) and by the International Diabetes Federation (IDF). A major difference between these 2 sets of criteria is that the IDF places more emphasis on waist circumference. We compared the prevalence of MS using the ATP III and the IDF guidelines in 2 American (the Dallas Health Study and National Health and Nutrition Examination Survey) and 1 German (Prospective Cardiovascular Munster study) population samples. When the ATP III criteria were used, the prevalence of MS was higher in the United States than the German samples in both women (37% vs. 18%) and men (30% vs 25%), whereas when the IDF criteria were used, the prevalence of MS was 25% higher in the German than the American sample. Although in the United States both sets of criteria identified mostly the same people (concordance of about 90%), this was less true in Germany (concordance about 80%). To determine which criteria better predicted adverse cardiovascular outcomes, the incidence of coronary events associated with MS, as defined using the ATP III or the IDF criteria, were compared over a 10-year period among the middle-aged men in the German sample (n = 7,152). A total of 3.4% of men without MS developed an event. A much higher percentage of the men with MS defined by the ATP III criteria (10.7%) than the IDF criteria (5.5%) had a cardiovascular event. In conclusion, although the prevalence of MS was higher when the IDF criteria were used in the German sample, the IDF criteria have lower predictive power for coronary events.

  1. Communication of 29 April 1996 received from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency regarding guidelines for the export of nuclear material, equipment and technology

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-06-07

    The document contains the text of a note verbale dated 29 April 1996 received by the Director General of IAEA from the Permanent Mission of the Russian Federation which provides information on the export policies and practices of the Government of the Russian Federation with respect to transfer of nuclear-related dual-use equipment, material and related technology.

  2. Communication of 29 April 1996 received from the Permanent Mission of the Russian Federation to the International Atomic Energy Agency regarding guidelines for the export of nuclear material, equipment and technology

    International Nuclear Information System (INIS)

    1996-01-01

    The document contains the text of a note verbale dated 29 April 1996 received by the Director General of IAEA from the Permanent Mission of the Russian Federation which provides information on the export policies and practices of the Government of the Russian Federation with respect to transfer of nuclear-related dual-use equipment, material and related technology

  3. Vulnerabilities to misinformation in online pharmaceutical marketing

    Science.gov (United States)

    De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

    2013-01-01

    Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users’ vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain. PMID:23761527

  4. Strategic Management of Innovations at Pharmaceutical Enterprises

    Directory of Open Access Journals (Sweden)

    Honcharova Svіtlana Yu.

    2014-01-01

    Full Text Available The article is devoted to theoretical and practical issues of the use of the concept of strategic management of innovations at pharmaceutical enterprises. It studies main barriers, which restrict development of Ukrainian pharmaceutical enterprises. It analyses the state and tendencies of development of innovation activity of pharmaceutical enterprises and studies foreign experience of innovation activity. It marks out specific features of strategic management of innovation development in pharmaceutical industry. It specifies the role and advantages of methods of strategic analysis in the system of management of a pharmaceutical enterprise. It considers the essence of “innovation development” and “innovation model of development” notions and analyses their organisational and legal provision. It justifies strategic tasks of the pharmaceutical filed to focus on in order to achieve a breakthrough when building an innovation model of economic development. The article proves that the most important factors that ensure growth of efficiency of pharmaceutical production are: wide application of the concept of strategic management and creation of innovations.

  5. Vulnerabilities to misinformation in online pharmaceutical marketing.

    Science.gov (United States)

    De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

    2013-05-01

    Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users' vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain.

  6. International Journal of Health Research: Submissions

    African Journals Online (AJOL)

    International Journal of Health Research: Submissions ... The journal is devoted to the promotion of pharmaceutical sciences and related disciplines ... adverse drug events, medical and other life sciences, and related engineering fields).

  7. Supramolecular Pharmaceutical Sciences: A Novel Concept Combining Pharmaceutical Sciences and Supramolecular Chemistry with a Focus on Cyclodextrin-Based Supermolecules.

    Science.gov (United States)

    Higashi, Taishi; Iohara, Daisuke; Motoyama, Keiichi; Arima, Hidetoshi

    2018-01-01

    Supramolecular chemistry is an extremely useful and important domain for understanding pharmaceutical sciences because various physiological reactions and drug activities are based on supramolecular chemistry. However, it is not a major domain in the pharmaceutical field. In this review, we propose a new concept in pharmaceutical sciences termed "supramolecular pharmaceutical sciences," which combines pharmaceutical sciences and supramolecular chemistry. This concept could be useful for developing new ideas, methods, hypotheses, strategies, materials, and mechanisms in pharmaceutical sciences. Herein, we focus on cyclodextrin (CyD)-based supermolecules, because CyDs have been used not only as pharmaceutical excipients or active pharmaceutical ingredients but also as components of supermolecules.

  8. Federal Fleet Report

    Data.gov (United States)

    General Services Administration — Annual report of Federal agencies' motor vehicle fleet data collected in the Federal Automotive Statistical Tool (FAST), a web-based reporting tool cosponsored by...

  9. Federal Register in XML

    Data.gov (United States)

    National Archives and Records Administration — The Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and...

  10. Radiation sterilization of pharmaceuticals and biomedical products

    International Nuclear Information System (INIS)

    Blackburn, R.; Iddon, B.; Moore, J.S.; Phillips, G.O.; Power, D.M.; Woodward, T.W.

    1975-01-01

    Sterilization of pharmaceuticals by radiation is accompanied by chemical degradation which must be eliminated or minimised if the method is to be successfully applied. In order to devise ways in which the pharmaceutical can be protected it is necessary to know the yield and nature of the decomposition products, the mechanisms by which degradation occurs, and the rate constants for the reactions involved. We have obtained such data for a variety of pharmaceutical compounds, viz. vitamin B12, benzyl penicillin, sulphonamides, indoles, heparin, alginates and phenylmercurics, both in the solid state and in aqueous solution. The scope and limitations of radiation sterilization are discussed in the light of these results. (author)

  11. Metrology in Pharmaceutical Industry - A Case Study

    International Nuclear Information System (INIS)

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

    2016-01-01

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

  12. 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.

  13. ACHP | Unified Federal Review

    Science.gov (United States)

    Search skip specific nav links Home arrow Unified Federal Review Three logos: 1) Executive Office of the Homeland Security. Unified Federal Environmental and Historic Preservation Review Process Please visit the new location for the Unified Federal Review located here: http://www.fema.gov/environmental-historic

  14. Framing Canadian federalism

    National Research Council Canada - National Science Library

    Saywell, John; Anastakis, Dimitry; Bryden, Penny E

    2009-01-01

    ... the pervasive effects that federalism has on Canadian politics, economics, culture, and history, and provide a detailed framework in which to understand contemporary federalism. Written in honour of John T. Saywell's half-century of accomplished and influential scholarly work and teaching, Framing Canadian Federalism is a timely and fitting t...

  15. 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

  16. ORIGINS AND RAMIFICATIONS OF PHARMACEUTICALS & ...

    Science.gov (United States)

    There is no abstract available for this product. If further information is requested, please refer to the bibliographic citation and contact the person listed under Contact field. 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.Subtask 1: To integrate state-of-the-art technologies (polar organic chemical integrative samplers, advanced solid-phase extraction methodologies with liquid chromatography/electrospray/mass spectrometry) and apply them to studying the sources and fate of a select list of PPCPs. Application and improvement of analytical methodologies that can detect non-volatile, polar, water-soluble pharmaceuticals in source waters at levels that could be environmentally significant (at concentrations less than parts per billion, ppb). IAG with USGS ends in FY05. APM 20 due in FY05.Subtask 2: Coordination of interagency research and public outreach activities for PPCPs. Participate on NSTC Health and Environment subcommittee working group on PPCPs. Web site maintenance and expansion, invited technical presentations, invited articles for peer-reviewed journals, interviews for media, responding to public inquiries. S

  17. ORIGINS AND RAMIFICATIONS OF PHARMACEUTICALS ...

    Science.gov (United States)

    Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the personal activities of individual citizens and their environment. PPCPS, in contrast to other types of pollutants, owe their origins in the environment directly to their worldwide, universal, frequent, highly dispersed, and individually small but cumulative usage by multitudes of individuals - as opposed to the larger, highly delineated, and more controllable industrial manufacturing/usage of most high- volume synthetic chemicals. Many PPCPs (as well as their metabolites and transformation products) can enter the environment following ingestion or application by the user or administration to domestic animals. Disposal of unused/expired PPCPs in landfills and in domestic sewage is another route to the environment. The aquatic environment serves as the major, ultimate receptacle for these chemicals, for which little is known with respect to actual or potential adverse effects. Domestic sewage treatment plants are not designed to remove PPCPS, and the efficiencies with which they are removed vary from nearly complete to ineffective. While PPCPs in the environment (or domestic drinking water) are not regulated, and even though their concentrations are extremely low (ng/L-@Lg/L), the consequences of exposure to multiple compounds having different as w

  18. Mixed Reality Meets Pharmaceutical Development.

    Science.gov (United States)

    Forrest, William P; Mackey, Megan A; Shah, Vivek M; Hassell, Kerry M; Shah, Prashant; Wylie, Jennifer L; Gopinath, Janakiraman; Balderhaar, Henning; Li, Li; Wuelfing, W Peter; Helmy, Roy

    2017-12-01

    As science evolves, the need for more efficient and innovative knowledge transfer capabilities becomes evident. Advances in drug discovery and delivery sciences have directly impacted the pharmaceutical industry, though the added complexities have not shortened the development process. These added complexities also make it difficult for scientists to rapidly and effectively transfer knowledge to offset the lengthened drug development timelines. While webcams, camera phones, and iPads have been explored as potential new methods of real-time information sharing, the non-"hands-free" nature and lack of viewer and observer point-of-view render them unsuitable for the R&D laboratory or manufacturing setting. As an alternative solution, the Microsoft HoloLens mixed-reality headset was evaluated as a more efficient, hands-free method of knowledge transfer and information sharing. After completing a traditional method transfer between 3 R&D sites (Rahway, NJ; West Point, PA and Schnachen, Switzerland), a retrospective analysis of efficiency gain was performed through the comparison of a mock method transfer between NJ and PA sites using the HoloLens. The results demonstrated a minimum 10-fold gain in efficiency, weighing in from a savings in time, cost, and the ability to have real-time data analysis and discussion. In addition, other use cases were evaluated involving vendor and contract research/manufacturing organizations. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  19. Emerging pharmaceutical therapies for COPD

    Science.gov (United States)

    Lakshmi, Sowmya P; Reddy, Aravind T; Reddy, Raju C

    2017-01-01

    COPD, for which cigarette smoking is the major risk factor, remains a worldwide burden. Current therapies provide only limited short-term benefit and fail to halt progression. A variety of potential therapeutic targets are currently being investigated, including COPD-related proinflammatory mediators and signaling pathways. Other investigational compounds target specific aspects or complications of COPD such as mucus hypersecretion and pulmonary hypertension. Although many candidate therapies have shown no significant effects, other emerging therapies have improved lung function, pulmonary hypertension, glucocorticoid sensitivity, and/or the frequency of exacerbations. Among these are compounds that inhibit the CXCR2 receptor, mitogen-activated protein kinase/Src kinase, myristoylated alanine-rich C kinase substrate, selectins, and the endothelin receptor. Activation of certain transcription factors may also be relevant, as a large retrospective cohort study of COPD patients with diabetes found that the peroxisome proliferator-activated receptor γ (PPARγ) agonists rosiglitazone and pioglitazone were associated with reduced COPD exacerbation rate. Notably, several therapies have shown efficacy only in identifiable subgroups of COPD patients, suggesting that subgroup identification may become more important in future treatment strategies. This review summarizes the status of emerging therapeutic pharmaceuticals for COPD and highlights those that appear most promising. PMID:28790817

  20. A evolução do sistema internacional de propriedade intelectual: proteção patentária para o setor farmacêutico e acesso a medicamentos Evolution of the international intellectual property rights system: patent protection for the pharmaceutical industry and access to medicines

    Directory of Open Access Journals (Sweden)

    Gabriela Costa Chaves

    2007-02-01

    Full Text Available O artigo discute a evolução do sistema internacional de direitos de propriedade intelectual em três fases e as implicações para saúde pública, especialmente para a implementação de políticas de acesso a medicamentos. Durante a primeira fase, caracterizada pelas Convenções de Paris e de Berna, os países signatários determinavam os campos tecnológicos que seriam protegidos ou não. Na segunda fase, com a implementação do Acordo TRIPS pela OMC, os países são obrigados a garantir proteção patentária a todos os campos tecnológicos, inclusive para a indústria farmacêutica. Dentro das suas respectivas legislações nacionais, os países também têm a oportunidade de implementar o acesso às flexibilidades do TRIPS para medicamentos. Com a terceira fase, caracterizada pela negociação e assinatura de acordos comerciais bilaterais e regionais, os países terão que implementar medidas TRIPS-plus que podem ter implicações negativas para as flexibilidades do TRIPS e para políticas de acesso a medicamentos. Os autores concluem que a proposta atual de sistema internacional de direitos de propriedade intelectual favorece os direitos dos detentores de patentes, que deveriam estar em equilíbrio com os direitos à saúde para a população.This article discusses the evolution of the international intellectual property rights system in three phases and the implications for public health, especially for the implementation of policies for access to medicines. During the first phase, characterized by the Paris and Berne Convention, signatory countries defined which technological fields should be protected (or not. Under the second phase, with the enforcement of the WTO TRIPS Agreement, countries are obliged to grant patent protection for all technological fields, including for the pharmaceutical industry. Within their national legislations, countries also have the opportunity to implement access to TRIPS flexibilities for medicines

  1. PHARMACEUTICAL PARTNERSHIPS IN THE DEVELOPMENT OF NEW PHARMACEUTICALS

    Directory of Open Access Journals (Sweden)

    A. L. Bulgakov

    2018-01-01

    Full Text Available This article examines the causes for creating alliances between manufacturers and drug developers. The attention has also been paid to the classification of such partnerships depending on the level of integration. The classification is necessary for further study of relations in the alliances. It is important to understand how economically effective and justified such partnerships are. The aim of the study is to determine the reasons for creating partnerships between drug developers and manufacturers, and to work out a classification of partnerships in the field of pharmacology. Materials and methods. The study analyzes existing alliances, partnerships of Big Pharma companies such as Bayer AG, Merck & Co, Pfizer. Results and discussion. The variety of forms of partnerships allows all participants in this market to get from cooperation the benefits they need. Some seek to reduce risk, others look forward to gaining access to new research opportunities, the third seek to share knowledge for greater productivity. However, there is always the opposite side, they have to sacrifice something to get a market advantage. For example, increased integration leads to a reduction in the risk of drug creation, but also leads to a decrease in the company’s independence. Conclusion. The results of this study can be used later in the study of the financial effectiveness of pharmaceutical partnerships, as well as in exploring the causes of alliances’ collapses. Any partnership has its value and can be considered as an intangible asset of the company. However, at the moment, there is no universal way of assessing this type of active assets, therefore, classification is a key step in creating a model for determining the value of a partnership. 

  2. Differences in the volume of pharmaceutical advertisements between print general medical journals.

    Directory of Open Access Journals (Sweden)

    Jennifer Gettings

    Full Text Available BACKGROUND: Pharmaceutical advertisements have been argued to provide revenue that medical journals require but they are intended to alter prescribing behaviour and they are known to include low quality information. We determined whether a difference exists in the current level of pharmaceutical advertising in print general medical journals, and we estimated the revenue generated from print pharmaceutical advertising. METHODS: Six print general medical journals in Canada, the United States, and the United Kingdom were sampled between 2007 and 2012. The number of advertisements and other journal content in selected issues of the Canadian Medical Association Journal (CMAJ, Canadian Family Physician (CFP, Journal of the American Medical Association (JAMA, New England Journal of Medicine (NEJM, British Medical Journal (BMJ, and Lancet were determined. Revenue gained from pharmaceutical advertising was estimated using each journal's 2013 advertising price list. FINDINGS: The two Canadian journals sampled (CMAJ, CFP contained five times more advertisements than the two American journals (JAMA, NEJM, and two British journals (BMJ, Lancet (p<0.0001. The estimated annual revenue from pharmaceutical advertisements ranged from £0.025 million (for Lancet to £3.8 million (for JAMA. The cost savings due to revenue from pharmaceutical advertising to each individual subscriber ranged from £0.02 (for Lancet to £3.56 (for CFP per issue. CONCLUSION: The volume of pharmaceutical advertisements differs between general medical journals, with the two Canadian journals sampled containing the most advertisements. International and temporal variations suggest that there is an opportunity for all general medical journals to reduce the number of pharmaceutical advertisements, explore other sources of revenue, and increase transparency regarding sources of revenue.

  3. Stability of Dosage Forms in the Pharmaceutical Payload Aboard Space Missions

    Science.gov (United States)

    Du, Brian J.; Daniels, Vernie; Boyd, Jason L.; Crady, Camille; Satterfield, Rick; Younker, Diane R.; Putcha, Lakshmi

    2009-01-01

    Efficacious pharmaceuticals with adequate shelf lives are essential for successful space medical operations. Stability of pharmaceuticals, therefore, is of paramount importance for assuring the health and wellness of astronauts on future space exploration missions. Unique physical and environmental factors of space missions may contribute to the instability of pharmaceuticals, e.g., radiation, humidity and temperature variations. Degradation of pharmaceutical formulations can result in inadequate efficacy and/or untoward toxic effects, which could compromise astronaut safety and health. Methods: Four identical pharmaceutical payload kits containing 31 medications in different dosage forms (liquid, tablet, capsule, ointment and suppository) were transported to the International Space Station aboard the Space Shuttle (STS-121). One of the 4 kits was stored on the Shuttle and the other 3 were stored on the International Space Station (ISS) for return to Earth at 6-month interval aboard a pre-designated Shuttle flight for each kit. The kit stored on the Shuttle was returned to Earth aboard STS-121 and 2 kits from ISS were returned on STS 117 and STS-122. Results: Analysis of standard physical and chemical parameters of degradation was completed for pharmaceuticals returned by STS-121 after14 days, STS - 117 after11 months and STS 122 after 19 months storage aboard ISS. Analysis of all flight samples along with ground-based matching controls was completed and results were compiled. Conclusion: Evaluation of results from the shuttle (1) and ISS increments (2) indicate that the number of formulations degraded in space increased with duration of storage in space and was higher in space compared to their ground-based counterparts. Rate of degradation for some of the formulations tested was faster in space than on Earth. Additionally, some of the formulations included in the medical kits were unstable, more so in space than on the ground. These results indicate that the

  4. Assessing the assessments: Pharmaceuticals in the environment

    International Nuclear Information System (INIS)

    Enick, O.V.; Moore, M.M.

    2007-01-01

    The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accurately reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development

  5. Information flow in the pharmaceutical supply chain.

    Science.gov (United States)

    Yousefi, Nazila; Alibabaei, Ahmad

    2015-01-01

    Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead.

  6. ENVIRONMENTAL STEWARDSHIP OF PHARMACEUTICALS - THE GREEN PHARMACY

    Science.gov (United States)

    The occurrence of pharmaceuticals and personal care products (PPCPS) as environmental pollutants is a multifaceted issue whose scope continues to become better delineated since the escalation of conceited attention beginning in the 1980s. PPCPs typically occur as trace environme...

  7. 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.

  8. Pharmaceutical and pharmacological approaches for bioavailability

    Indian Academy of Sciences (India)

    2014-01-27

    Jan 27, 2014 ... Etoposide posses high plasma protein binding (97%) and is degraded via ... The present article gives insight on pharmaceutical and pharmacological .... caprolactone and were found efficient as drug delivery vehicles.

  9. Pharmaceutical Research and Manufacturers of America

    Science.gov (United States)

    ... Trials Pediatrics The Value Collaborative 340B Science x Science Today, cutting-edge medical science is transforming patients’ ... Prescription Medicines: Costs in Context SHARE THIS The Pharmaceutical Research and Manufacturers of America, PhRMA, represents the ...

  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. 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. Characterization of the medical department of pharmaceutical companies operating in Portugal

    Directory of Open Access Journals (Sweden)

    Acílio Gala

    2017-04-01

    Full Text Available In a context of strong regulatory demands and high economic pressures and constraints, medical departments within pharmaceutical companies, have demonstrated its strategic relevance even though the functions to embrace are not globally consensual. In this context, a study that intended to analyse the management of medical activities, in pharmaceutical companies operating in Portugal, including allocated human resources and investment trends, was implemented. Quantitative information was collected through an electronic survey, in pharmaceutical companies with activity in Portugal. The analysis of the results supported the conclusion that the majority of the companies are affiliates of international companies and that 79% of them have formalized medical departments. The human resources of the medical departments of the participant companies include several professional classes, with predominance of pharmacists. Globally, the number of employees of the medical area has registered a systematic growth in the last years. It was also possible to conclude that the majority of the companies are increasing the investment in medical affairs activities. This study enables the understanding of these activities in pharmaceutical companies operating in Portugal, within the international panorama of pharmaceutical industry. It contributes to improve the knowledge about the relevance of medical departments while enabling the definition of novel pathways to increase the competiveness and sustainability of the companies.

  13. Changing the field of carcinogenicity testing of human pharmaceuticals by emphasizing mode of action

    NARCIS (Netherlands)

    Laan, J.W. van der; Duijndam, B.; Hoorn, T. van den; Woutersen, R.; Water, B. van de

    2017-01-01

    Lifetime testing for carcinogenicity of pharmaceuticals in rodents has been a controversial issue since the start of the International Conference on Harmonisation in 1990. Since 2010 the debate reached a new level following the proposal that a negative outcome of carcinogenicity studies can be

  14. Sales Growth of New Pharmaceuticals Across the Globe: The Role of Regulatory Regimes

    NARCIS (Netherlands)

    S. Stremersch (Stefan); A. Lemmens (Aurélie)

    2008-01-01

    textabstractPrior marketing literature has overlooked the role of regulatory regimes in explaining international sales growth of new products. This paper addresses this gap in the context of new pharmaceuticals (15 new molecules in 34 countries) and sheds light on the effect regulatory regimes have

  15. A Simple Model of Pharmaceutical Price Dynamics

    OpenAIRE

    Bhattacharya, Jayanta; Vogt, William B

    2003-01-01

    Branded pharmaceutical firms use price and promotional strategy to manage public knowledge about their drugs. We propose a dynamic theory of pharmaceutical pricing and conduct an exploratory empirical analysis inspired by the theory. Our theory predicts a pattern of increasing prices and decreasing promotional activities over a drug's life cycle. Prices are kept low and advertising levels high early in the life cycle in order to build public knowledge about the drug. As knowledge grows, price...

  16. 'Linkage' pharmaceutical evergreening in Canada and Australia

    OpenAIRE

    Faunce, Thomas A; Lexchin, Joel

    2007-01-01

    'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong...

  17. Pharmaceutical Distribution Market Channels in Poland

    Directory of Open Access Journals (Sweden)

    Agnieszka Woś

    2009-09-01

    Full Text Available Distribution on the pharmaceutical market in Poland is interesting and the most difficult sphere to manage. Numerous varied and specialized companies operating on the market cause that the processes of choosing middlemen in distribution channels are very complex. The hereby article presents the role and location of the companies operating within distribution channels on the pharmaceutical market. It draws attention to the development of non-pharmacy and non-wholesale sales channels.

  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. Optimization of the pharmaceutical care system for diabetes patients using modern pharmaceutical informatics methodology

    Directory of Open Access Journals (Sweden)

    Андрій Ігорович Бойко

    2016-04-01

    Full Text Available Aim. Implementation of pharmaceutical informatics methods in the system of pharmaceutical care for diabetes patients in Ukraine.Methods. System method was used for the analysis of status and reforming the pharmaceutical care for patients with diabetes; program-oriented management at informatization project realization; pharmaceutical informatics in the creation of computer pharmaceutical knowledge bases; methods of data synthesis and summarizing.Results. System analysis of the basic directions of reforming the pharmaceutical care for patients with diabetes in Ukraine was carried out. Ways of it’s of optimization were processed: establishment of specialized pharmacies with implementation of modern information technologies and special postgraduate education for pharmacists. Structure and information providing of computer knowledge base “Pharmaceutical care for patients with diabetes” was substantiated.Conclusion. Based on the regional project “Informatization of prescription antidiabetic drugs circulation in Ukraine” realization, the necessity of establishment of specialized pharmacies providing pharmaceutical care for patients with diabetes was substantiated. Ways for optimization of postgraduate education for pharmacists of the specialized pharmacies by implementation of special thematic improvement cycles were proceed. Computer knowledge base as an effective tool for optimization of pharmaceutical care for patients with diabetes was realized

  20. Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to U.S. wastewaters

    Science.gov (United States)

    Scott, Tia-Marie; Phillips, Patrick J.; Kolpin, Dana W.; Colella, Kaitlyn M.; Furlong, Edward T.; Foreman, William T.; Gray, James L.

    2018-01-01

    Discharges from pharmaceutical manufacturing facilities (PMFs) previously have been identified as important sources of pharmaceuticals to the environment. Yet few studies are available to establish the influence of PMFs on the pharmaceutical source contribution to wastewater treatment plants (WWTPs) and waterways at the national scale. Consequently, a national network of 13 WWTPs receiving PMF discharges, six WWTPs with no PMF input, and one WWTP that transitioned through a PMF closure were selected from across the United States to assess the influence of PMF inputs on pharmaceutical loading to WWTPs. Effluent samples were analyzed for 120 pharmaceuticals and pharmaceutical degradates. Of these, 33 pharmaceuticals had concentrations substantially higher in PMF-influenced effluent (maximum 555,000 ng/L) compared to effluent from control sites (maximum 175 ng/L). Concentrations in WWTP receiving PMF input are variable, as discharges from PMFs are episodic, indicating that production activities can vary substantially over relatively short (several months) periods and have the potential to rapidly transition to other pharmaceutical products. Results show that PMFs are an important, national-scale source of pharmaceuticals to the environment.

  1. THz spectroscopy: An emerging technology for pharmaceutical development and pharmaceutical Process Analytical Technology (PAT) applications

    Science.gov (United States)

    Wu, Huiquan; Khan, Mansoor

    2012-08-01

    As an emerging technology, THz spectroscopy has gained increasing attention in the pharmaceutical area during the last decade. This attention is due to the fact that (1) it provides a promising alternative approach for in-depth understanding of both intermolecular interaction among pharmaceutical molecules and pharmaceutical product quality attributes; (2) it provides a promising alternative approach for enhanced process understanding of certain pharmaceutical manufacturing processes; and (3) the FDA pharmaceutical quality initiatives, most noticeably, the Process Analytical Technology (PAT) initiative. In this work, the current status and progress made so far on using THz spectroscopy for pharmaceutical development and pharmaceutical PAT applications are reviewed. In the spirit of demonstrating the utility of first principles modeling approach for addressing model validation challenge and reducing unnecessary model validation "burden" for facilitating THz pharmaceutical PAT applications, two scientific case studies based on published THz spectroscopy measurement results are created and discussed. Furthermore, other technical challenges and opportunities associated with adapting THz spectroscopy as a pharmaceutical PAT tool are highlighted.

  2. 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...

  3. 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...

  4. Pharmaceutical regulation in 15 European countries review.

    Science.gov (United States)

    Panteli, Dimitra; Arickx, Francis; Cleemput, Irina; Dedet, Guillaume; Eckhardt, Helen; Fogarty, Emer; Gerkens, Sophie; Henschke, Cornelia; Hislop, Jennifer; Jommi, Claudio; Kaitelidou, Daphne; Kawalec, Pawel; Keskimaki, Ilmo; Kroneman, Madelon; Lopez Bastida, Julio; Pita Barros, Pedro; Ramsberg, Joakim; Schneider, Peter; Spillane, Susan; Vogler, Sabine; Vuorenkoski, Lauri; Wallach Kildemoes, Helle; Wouters, Olivier; Busse, Reinhard

    2016-10-01

    In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. With the aim of guiding the health policy discourse towards questions that are important to actual and potential patients, this study investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution and resulting price levels in a sample of 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical care, albeit with varying configurations and rigour. This variation also influences the extent of publicly financed pharmaceutical costs. Overall, observed differences in pharmaceutical expenditure should be interpreted in conjunction with the differing volume and composition of consumption and price levels, as well as dispensation practices and their impact on measurement of pharmaceutical costs. No definitive evidence has yet been produced on the effects of different cost-containment measures on patient outcomes. Depending on the foremost policy concerns in each country, different levers will have to be used to enable the delivery of appropriate care at affordable prices. World Health Organization 2016 (acting as the host organization for, and secretariat of, the European Observatory on Health Systems and Policies).

  5. Pharmaceutical care education in Kuwait: pharmacy students’ perspectives

    OpenAIRE

    Katoue, Maram G.; Awad, Abdelmoneim I.; Schwinghammer, Terry L.; Kombian, Samuel B.

    2014-01-01

    Background: Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients’ quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective: To investigate pharmacy students’ attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance...

  6. Pharmaceutical drug detailing in primary care: extent and methods

    DEFF Research Database (Denmark)

    Schramm, Jesper

    The dimension and methods of pharmaceutical marketing towards 47 danish general practitioners is described. Conclusions: Pharmaceutical drug detailing possesses a huge potential to influence the prescription pattern of GP's.......The dimension and methods of pharmaceutical marketing towards 47 danish general practitioners is described. Conclusions: Pharmaceutical drug detailing possesses a huge potential to influence the prescription pattern of GP's....

  7. Emerging pharmaceutical therapies for COPD

    Directory of Open Access Journals (Sweden)

    Lakshmi SP

    2017-07-01

    Full Text Available Sowmya P Lakshmi,1,2 Aravind T Reddy,1,2 Raju C Reddy1,2 1Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh School of Medicine, 2Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, PA, USA Abstract: COPD, for which cigarette smoking is the major risk factor, remains a worldwide burden. Current therapies provide only limited short-term benefit and fail to halt progression. A variety of potential therapeutic targets are currently being investigated, including COPD-related proinflammatory mediators and signaling pathways. Other investigational compounds target specific aspects or complications of COPD such as mucus hypersecretion and pulmonary hypertension. Although many candidate therapies have shown no significant effects, other emerging therapies have improved lung function, pulmonary hypertension, glucocorticoid sensitivity, and/or the frequency of exacerbations. Among these are compounds that inhibit the CXCR2 receptor, mitogen-activated protein kinase/Src kinase, myristoylated alanine-rich C kinase substrate, selectins, and the endothelin receptor. Activation of certain transcription factors may also be relevant, as a large retrospective cohort study of COPD patients with diabetes found that the peroxisome proliferator-activated receptor γ (PPARγ agonists rosiglitazone and pioglitazone were associated with reduced COPD exacerbation rate. Notably, several therapies have shown efficacy only in identifiable subgroups of COPD patients, suggesting that subgroup identification may become more important in future treatment strategies. This review summarizes the status of emerging therapeutic pharmaceuticals for COPD and highlights those that appear most promising. Keywords: pulmonary, PPAR, phosphodiesterase, emphysema, cigarette, mucus 

  8. Stem cells in pharmaceutical biotechnology.

    Science.gov (United States)

    Zuba-Surma, Ewa K; Józkowicz, Alicja; Dulak, Józef

    2011-11-01

    Multiple populations of stem cells have been indicated to potentially participate in regeneration of injured organs. Especially, embryonic stem cells (ESC) and recently inducible pluripotent stem cells (iPS) receive a marked attention from scientists and clinicians for regenerative medicine because of their high proliferative and differentiation capacities. Despite that ESC and iPS cells are expected to give rise into multiple regenerative applications when their side effects are overcame during appropriate preparation procedures, in fact their most recent application of human ESC may, however, reside in their use as a tool in drug development and disease modeling. This review focuses on the applications of stem cells in pharmaceutical biotechnology. We discuss possible relevance of pluripotent cell stem populations in developing physiological models for any human tissue cell type useful for pharmacological, metabolic and toxicity evaluation necessary in the earliest steps of drug development. The present models applied for preclinical drug testing consist of primary cells or immortalized cell lines that show limitations in terms of accessibility or relevance to their in vivo counterparts. The availability of renewable human cells with functional similarities to their in vivo counterparts is the first landmark for a new generation of cell-based assays. We discuss the approaches for using stem cells as valuable physiological targets of drug activity which may increase the strength of target validation and efficacy potentially resulting in introducing new safer remedies into clinical trials and the marketplace. Moreover, we discuss the possible applications of stem cells for elucidating mechanisms of disease pathogenesis. The knowledge about the mechanisms governing the development and progression of multitude disorders which would come from the cellular models established based on stem cells, may give rise to new therapeutical strategies for such diseases. All

  9. Assessment of Parametrial Response by Growth Pattern in Patients With International Federation of Gynecology and Obstetrics Stage IIB and IIIB Cervical Cancer: Analysis of Patients From a Prospective, Multicenter Trial (EMBRACE)

    Energy Technology Data Exchange (ETDEWEB)

    Yoshida, Kenji [Medical University of Vienna, Comprehensive Cancer Center, Vienna (Austria); Kobe University Graduate School of Medicine, Kobe (Japan); Jastaniyah, Noha [Medical University of Vienna, Comprehensive Cancer Center, Vienna (Austria); King Faisal Specialist Hospital and Research Center, Riyadh (Saudi Arabia); Sturdza, Alina, E-mail: alina.sturdza@akhwien.at [Medical University of Vienna, Comprehensive Cancer Center, Vienna (Austria); Lindegaard, Jacob [Aarhus University Hospital, Aarhus (Denmark); Segedin, Barbara [Institute of Oncology Ljubljana, Ljubljana (Slovenia); Mahantshetty, Umesh [Tata Memorial Hospital, Mumbai (India); Rai, Bhavana [Post Graduate Institute of Medical Education and Research, Chandigarh (India); Jürgenliemk-Schulz, Ina [University Medical Center, Utrecht (Netherlands); Haie-Meder, Christine [Institut Gustave Roussy, Paris (France); Sasaki, Ryohei [Kobe University Graduate School of Medicine, Kobe (Japan); Pötter, Richard [Medical University of Vienna, Comprehensive Cancer Center, Vienna (Austria)

    2015-11-15

    Purpose: To assess disease response along the parametrial space according to tumor morphology in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIB and IIIB cervical cancer at the time of image-guided adaptive brachytherapy. Methods and Materials: Patients with FIGO stage IIB and IIIB cervical cancer registered as of November 2013 in the EMBRACE study were evaluated. Tumors were stratified according to morphologic subtype on magnetic resonance imaging (expansive and infiltrative), and the characteristics of those subtypes were analyzed. Parametrial involvement at diagnosis and at brachytherapy was evaluated, and the response to chemo-radiotherapy was classified as good, moderate, or poor. The response grade was compared between the 2 groups and analyzed with regard to tumor volumes, and dosimetric parameters. Results: A total of 452 patients were evaluated, of whom 186 had expansive growth type and 266 had infiltrative morphology. Patients with infiltrative tumors had more extensive disease, as indicated by a higher rate of FIGO stage IIIB disease, as well as radiologic evidence of extension into the distal parametrial space and to the pelvic side wall on magnetic resonance imaging. Cervical necrosis was more common in the infiltrative group. Good response was more common in the expansive group (34% vs 24%; P=.02), and poor response was more common in the infiltrative group (11% and 19%; P=.02). Mean gross tumor volume at diagnosis was equal in both groups (51.7 cm{sup 3}). The high-risk clinical target volume was larger in infiltrative tumors (37.9 cm{sup 3} vs 33.3 cm{sup 3}, P=.005). The mean high-risk clinical target volume D{sub 90} was slightly higher in expansive tumors (92.7 Gy and 89.4 Gy, P<.001). Conclusion: Infiltrative tumors are more advanced at presentation and respond less favorably to chemo-radiotherapy when compared with expansive tumors that are more or less equivalent in size. The use of image

  10. 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

  11. Pharmaceutical costs of assisted reproduction in Spain.

    Science.gov (United States)

    Lorente, Maria-Reyes; Hernández, Juana; Antoñanzas, Fernando

    2013-11-01

    Assisted reproduction is one of the health services currently being considered for possible limitation or exclusion from the public health services portfolio in Spain. One of the main reasons claimed for this is the impact on the budget for pharmaceutical expenditure. The objective of this study was to assess the significance of the pharmaceutical costs of assisted reproduction in Spain. This study focused on medical practice in Spain, and is based on the opinions of experts in assisted reproduction and the results provided by professional societies' publications. The reference year is 2012 and the setting was secondary care. We have included all existing pharmaceutical modalities for assisted reproduction, as well as the most common drug for each modality. We have considered the pharmaceutical cost per cycle for artificial insemination, in vitro fertilisation with or without intracytoplasmic sperm injection (IVF_ICSI), and cryotransfer and donated fresh oocytes reception. In Spain, artificial insemination has a pharmaceutical cost per cycle of between €69.36 and €873.79. This amounts to an average cycle cost of €364.87 for partner's sperm and €327.10 for donor sperm. The pharmaceutical cost of IVF_ICSI ranges between €278.16 and €1,902.66, giving an average cost per cycle of €1,139.65. In the case of cryotransfer and donated fresh oocytes reception, the pharmaceutical cost per cycle is between €22.61 and €58.73, yielding an average cost of €40.67. The budgetary impact of pharmaceutical expenditure for assisted reproduction in Spain for the year 2012 was estimated at €98.7 million. In Spain, the total pharmaceutical cost of assisted reproduction is substantial. According to our results, we can say that about 29% of the total pharmaceutical expenditure for assisted reproduction techniques is funded by the National Health System and the rest represents 2.4% of the total annual out-of-pocket family expenditure on drugs.

  12. Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

    OpenAIRE

    Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

    2016-01-01

    Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employe...

  13. An Export-Marketing Model for Pharmaceutical Firms (The Case of Iran)

    OpenAIRE

    Mohammadzadeh, Mehdi; Aryanpour, Narges

    2013-01-01

    Internationalization is a matter of committed decision-making that starts with export marketing, in which an organization tries to diagnose and use opportunities in target markets based on realistic evaluation of internal strengths and weaknesses with analysis of macro and microenvironments in order to gain presence in other countries. A developed model for export and international marketing of pharmaceutical companies is introduced. The paper reviews common theories of the internationalizati...

  14. ANALISIS FAKTOR INTERNAL DAN EKSTERNAL YANG TERKAIT DENGAN MODEL PELAYANAN PRIMA DI APOTEK

    Directory of Open Access Journals (Sweden)

    Max Joseph Herman

    2012-11-01

    Full Text Available The development of prime pharmaceutical services in pharmacies, especially from the aspect of drug information for chronic and degenerative disease in the year of 2003, gave a patient-oriented model focused on drug information services including communication, drug counseling and consulting as well as drug effect monitoring on patient. An explorative qualitative study was carried out to identify internal and external factors associated wtth prime pharmaceutical services in pharmacies so as measuring the gap amongst the pharmaceutical services model developed, the guidelines of pharmaceutical services in pharmacies, the existing practices in pharmaceutical services at this moment, pharmacists' professionalism and pharmaceutical faculty curiculum in an attempt to bridge the gap. The study carried out in 2004 on pharmacists, pharmacist assistants and the owners of 40 pharmacies in Jakarta, Yogyakarta and Makassar. Data were collected using interviews, Focus Group Discussion, Checklist and observation, covering the opinion of Directorate General of Pharmaceutical Services, District and Provincial Health Offices, Central and Regional Indonesian Pharmacist Association, Pharmaceutical Company Association, pharmaceutical faculty, NGO and practitioners. Internal and external factors that influence pharmaceutical services in pharmacies were analyzed using SWOT method to solve problems in the implementation of prime pharmaceutical in pharmacies model. Results of the study showed that the tendency to perform prime pharmaceutical services in pharmacies is great enough, especially in conjunction with conducive regulation and an opportunity to promote the quality of human resources in pharmacies. Key words: prime pharmaceutical services, pharmacies, SWOT analysis

  15. Supercritical fluid technology: concepts and pharmaceutical applications.

    Science.gov (United States)

    Deshpande, Praful Balavant; Kumar, G Aravind; Kumar, Averineni Ranjith; Shavi, Gopal Venkatesh; Karthik, Arumugam; Reddy, Meka Sreenivasa; Udupa, Nayanabhirama

    2011-01-01

    In light of environmental apprehension, supercritical fluid technology (SFT) exhibits excellent opportunities to accomplish key objectives in the drug delivery sector. Supercritical fluid extraction using carbon dioxide (CO(2)) has been recognized as a green technology. It is a clean and versatile solvent with gas-like diffusivity and liquid-like density in the supercritical phase, which has provided an excellent alternative to the use of chemical solvents. The present commentary provides an overview of different techniques using supercritical fluids and their future opportunity for the drug delivery industry. Some of the emerging applications of SFT in pharmaceuticals, such as particle design, drug solubilization, inclusion complex, polymer impregnation, polymorphism, drug extraction process, and analysis, are also covered in this review. The data collection methods are based on the recent literature related to drug delivery systems using SFT platforms. SFT has become a much more versatile and environmentally attractive technology that can handle a variety of complicated problems in pharmaceuticals. This cutting-edge technology is growing predominantly to surrogate conventional unit operations in relevance to the pharmaceutical production process. Supercritical fluid technology has recently drawn attention in the field of pharmaceuticals. It is a distinct conception that utilizes the solvent properties of supercritical fluids above their critical temperature and pressure, where they exhibit both liquid-like and gas-like properties, which can enable many pharmaceutical applications. For example, the liquid-like properties provide benefits in extraction processes of organic solvents or impurities, drug solubilization, and polymer plasticization, and the gas-like features facilitate mass transfer processes. It has become a much more versatile and environmentally attractive technology that can handle a variety of complicated problems in pharmaceuticals. This review is

  16. Pharmaceutical Formulation Facilities as Sources of Opioids and Other Pharmaceuticals to Wastewater Treatment Plant Effluents

    Science.gov (United States)

    2010-01-01

    Facilities involved in the manufacture of pharmaceutical products are an under-investigated source of pharmaceuticals to the environment. Between 2004 and 2009, 35 to 38 effluent samples were collected from each of three wastewater treatment plants (WWTPs) in New York and analyzed for seven pharmaceuticals including opioids and muscle relaxants. Two WWTPs (NY2 and NY3) receive substantial flows (>20% of plant flow) from pharmaceutical formulation facilities (PFF) and one (NY1) receives no PFF flow. Samples of effluents from 23 WWTPs across the United States were analyzed once for these pharmaceuticals as part of a national survey. Maximum pharmaceutical effluent concentrations for the national survey and NY1 effluent samples were generally effluent had median concentrations ranging from 3.4 to >400 μg/L. Maximum concentrations of oxycodone (1700 μg/L) and metaxalone (3800 μg/L) in samples from NY3 effluent exceeded 1000 μg/L. Three pharmaceuticals (butalbital, carisoprodol, and oxycodone) in samples of NY2 effluent had median concentrations ranging from 2 to 11 μg/L. These findings suggest that current manufacturing practices at these PFFs can result in pharmaceuticals concentrations from 10 to 1000 times higher than those typically found in WWTP effluents. PMID:20521847

  17. Federal environmental inspections handbook

    International Nuclear Information System (INIS)

    1991-10-01

    This Federal Environmental Inspection Handbook has been prepared by the Department of Energy (DOE), Office of Environmental Guidance, RCRA/CERCLA Division (EH-231). It is designed to provide DOE personnel with an easily accessible compilation of the environmental inspection requirements under Federal environmental statutes which may impact DOE operations and activities. DOE personnel are reminded that this Handbook is intended to be used in concert with, and not as a substitute for, the Code of Federal Regulations (CFR). Federal Register (FR), and other applicable regulatory documents

  18. SOME ASPECTS OF THE MARKETING STUDIES FOR THE PHARMACEUTICAL MARKET OF ANTIVIRAL DRUGS

    Directory of Open Access Journals (Sweden)

    A. G. Salnikova

    2015-01-01

    Full Text Available Antiviral drugs are widely used in medicinal practice. They suppress the originator and stimulate the protection of an organism. The drugs are used for the treatment of flu and ARVI, herpetic infections, virus hepatitis, HIV-infection. Contemporary pharmaceutical market is represented by a wide range of antiviral drugs. Marketing studies are conducted to develop strategies, used for the enhancement of pharmacy organization activity efficiency. Conduction of the marketing researches of pharmaceutical market is the purpose of this study. We have used State Registry of Drugs, State Record of Drugs, List of vital drugs, questionnaires of pharmaceutical workers during our work. Historical, sociological, mathematical methods, and a method of expert evaluation were used in the paper. As the result of the study we have made the following conclusions. We have studied and generalized the literature data about classification and application of antiviral drugs, marketing, competition. The assortment of antiviral drugs on the pharmaceutical market of the Russian Federation was also studied. We have conducted an analysis for the obtainment of the information about antiviral drugs by pharmaceutical workers. We have determined the competitiveness of antiviral drugs, and on the basis of the research conducted we have submitted an offer for pharmaceutical organizations to form the range of antiviral drugs.

  19. An export-marketing model for pharmaceutical firms (the case of iran).

    Science.gov (United States)

    Mohammadzadeh, Mehdi; Aryanpour, Narges

    2013-01-01

    Internationalization is a matter of committed decision-making that starts with export marketing, in which an organization tries to diagnose and use opportunities in target markets based on realistic evaluation of internal strengths and weaknesses with analysis of macro and microenvironments in order to gain presence in other countries. A developed model for export and international marketing of pharmaceutical companies is introduced. The paper reviews common theories of the internationalization process, followed by examining different methods and models for assessing preparation for export activities and examining conceptual model based on a single case study method on a basket of seven leading domestic firms by using mainly questionares as the data gathering tool along with interviews for bias reduction. Finally, in keeping with the study objectives, the special aspects of the pharmaceutical marketing environment have been covered, revealing special dimensions of pharmaceutical marketing that have been embedded within the appropriate base model. The new model for international activities of pharmaceutical companies was refined by expert opinions extracted from result of questionnaires.

  20. 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.

  1. An Export-Marketing Model for Pharmaceutical Firms (The Case of Iran)

    Science.gov (United States)

    Mohammadzadeh, Mehdi; Aryanpour, Narges

    2013-01-01

    Internationalization is a matter of committed decision-making that starts with export marketing, in which an organization tries to diagnose and use opportunities in target markets based on realistic evaluation of internal strengths and weaknesses with analysis of macro and microenvironments in order to gain presence in other countries. A developed model for export and international marketing of pharmaceutical companies is introduced. The paper reviews common theories of the internationalization process, followed by examining different methods and models for assessing preparation for export activities and examining conceptual model based on a single case study method on a basket of seven leading domestic firms by using mainly questionares as the data gathering tool along with interviews for bias reduction. Finally, in keeping with the study objectives, the special aspects of the pharmaceutical marketing environment have been covered, revealing special dimensions of pharmaceutical marketing that have been embedded within the appropriate base model. The new model for international activities of pharmaceutical companies was refined by expert opinions extracted from result of questionnaires. PMID:24250597

  2. Concept of the Ural pharmaceutical cluster formation

    Directory of Open Access Journals (Sweden)

    Aleksandr Petrovich Petrov

    2011-06-01

    Full Text Available This paper substantiates the necessity of cluster organization of the pharmaceutical industry in the region. The estimation of the state and prospects of development of such structures in the domestic economy is given. Sverdlovsk region was chosen as the object of study on the possibility of forming a pharmaceutical cluster. Objective prerequisites for the organization of a cluster of pharmaceutical production in Sverdlovsk region are considered, among these were distinguished: capacious and fast-growing market for pharmaceutical products, availability of potential development of the pharmaceutical industry in the territory and the key success factors for enterprises - potential participants of the cluster. Indicated key success factors are: presence of a creative team and close interaction between business and government, high level of cooperation among the enterprises of the cluster and commercialization of products, implementation of research and development expenditures etc. Thus, it was substantiated that in there all references and resources for the formation of a pharmaceutical cluster. The concept of formation and development of the Ural pharmaceutical cluster was elaborated. Inside the concept, the goals, objectives, processing, product and organizational priorities for cluster formation are identified. Architecture of this structure with a justification of its members and certain forms of interaction between them is proposed. The stages of formation and development of the Ural pharmaceutical cluster on the basis of a ten-year settlement period for the full range of activities for this project are substantiated. At each stage, a set of key objectives and results of the cluster was defined. The choice of phases was carried out on the basis of investment programs of cluster's enterprises strategic position on the mastering of markets and infrastructure development. An assessment of socio-economic efficiency of the Ural pharmaceutical

  3. [An analysis of the pharmaceuticals market in Vietnam].

    Science.gov (United States)

    Simonet, D

    2001-01-01

    pharmaceutical researchers. A strong decentralisation process characterises the pharmaceutical sector, with pharmacies in the provinces and districts while wholesalers remain located in Hanoi and Saigon. The presence of many middlemen has contributed to an increase in prices. Today, a concentration of pharmacies is still noted in inner cities while the suburbs and the villages still have difficulties supplying drugs for inhabitants. Solutions have been implemented such as the opening of new pharmacies and additional professional training for pharmacists. Prices were lowered while the quality of the supply chain was improved. Local production is encouraged as hospitals are prompted to prescribe Vietnamese products. The modernisation of the Vietnamese pharmaceutical industry is also visible through the importation of medical materials and an increase in the number of private hospitals financed with both the help of local and foreign investors, mainly through joint-ventures, most often in Saigon and Hanoi. The renovation of local hospitals was also possible with the help of France and Japan. Columbia Gia Dinh International, located in Saigon, is one of the very few US/Vietnamese medical institutions created with a local partner, the Gia Dinh hospital. The recovery of the economy will accelerate the creation of new projects designed to improve local medical infrastructures. Other private companies, some of which are based in Singapore, have been specifically designed to deliver care to expatriates working in Vietnam. Insurance coverage has been provided in Vietnam since in 1992. Other improvements concern the implementation of "Good Manufacturing Practices" (GMP) and "Good Laboratory Practices" and "Good Storage Practices". Most norms were implemented at the end of the 90s in joint companies linking foreign investors and local partners or in independent foreign drug manufacturers based in Vietnam. Special areas were created to receive high tech investments in the medical and

  4. Radiation sterilization of some pharmaceutical preparations and medical products

    International Nuclear Information System (INIS)

    Tashmetov, M.Yu.; Makhkamov, Sh.M.; Urinov, Sh.S.; Turaev, A.S.; Sultanov, M.S.; Inagomov, Kh.S.

    2006-01-01

    Full text: In connection with intensive development of pharmacology and medical techniques, use of the products contacting to blood, with the internal environment of an organism, with wound surface, with mucous membranes and skin there were high requirements to sterility of pharmaceutical preparations and medical products. Traditional methods of sterilization (heat treatment, gas processing and processing the ferry) have some restrictions in application, and not insufficient degree of sterilization required for pharmaceutical preparations and medical products. Thermal processing can lead to degradation of structure (medicine), mechanical changes and loss of medical properties. Besides, it is impossible to carry out sterilization of many pharmaceutical preparations by a method of heat treatment. Sterilization of products in packing is very complicated, because sterilization temperature of packing and a product is different. Gas processing is basically applied to sterilization of medical products (syringes, bandage, cotton wools, etc.). However, the degree of sterility is low, because of rather low ability and heterogeneity of sterilizing substance. Sterilization in packing represents special difficulty and demands additional charges related with delivery of the purified gas from abroad. Last years alongside with known technological methods of sterilization of medical products and pharmaceutical preparations radiating methods of processing have found wide application. Use of electronic bunches with the moderate energy and various isotopes became a basis for formation and development of a new direction in the medicine, called by 'radiation sterilization'. The radiation technology is highly harmless and economic, not polluting substance and surrounding space. Unlike the specified traditional methods, radiating processing of products by the isotope 60 Co, radiating the gamma quantum, has unique opportunities - high penetrability in substance, providing uniformity of

  5. Case histories in pharmaceutical risk management.

    Science.gov (United States)

    McCormick, Cynthia G; Henningfield, Jack E; Haddox, J David; Varughese, Sajan; Lindholm, Anders; Rosen, Susan; Wissel, Janne; Waxman, Deborah; Carter, Lawrence P; Seeger, Vickie; Johnson, Rolley E

    2009-12-01

    The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Administration (FDA) since the mid 1990s. This paper provides four case histories of risk management and post-marketing surveillance programs utilized recently to address problems associated with possible abuse, dependence and diversion. The pharmaceutical sponsors of each of these drugs were invited to present their programs and followed a similar template for their summaries that are included in this article. The drugs and presenting companies were OxyContin, an analgesic marketed by Purdue Pharma L.P., Daytrana and Vyvanse, ADHD medications marketed by Shire Pharmaceuticals, Xyrem for narcolepsy marketed by Jazz Pharmaceuticals, and Subutex and Suboxone for opioid dependence marketed by Reckitt Benckiser Pharmaceuticals Inc. These case histories and subsequent discussions provide invaluable real-world examples and illustrate both the promise of risk management programs in providing a path to market and/or for keeping on the market drugs with serious potential risks. They also illustrate the limitations of such programs in actually controlling unintended consequences, as well as the challenge of finding the right balance of reducing risks without posing undue barriers to patient access. These experiences are highly relevant as the FDA increasingly requires pharmaceutical sponsors to develop and implement the more formalized and enforceable versions of the risk management term Risk Evaluation and Mitigation Strategies (REMS).

  6. Pharmaceutical policy and the pharmacy profession

    DEFF Research Database (Denmark)

    Traulsen, Janine Marie; Almarsdóttir, Anna Birna

    2005-01-01

    In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy and indu......In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy...... and industrial policy. In order to analyse and understand pharmaceutical policy, it is important to know how policymakers view pharmacy and pharmacists. The authors look at the issues that arise when policy regulates pharmacy as a business, and what this means for the profession. The perspective of pharmacy...... in managerialism, and how the division of labour with other health professionals such as physicians and pharmacy assistants is affecting the pharmacy profession's position in the labour market. Next the authors look at ways in which the pharmacy profession has affected policy. Pharmacists have been instrumental...

  7. 'Linkage' pharmaceutical evergreening in Canada and Australia

    Science.gov (United States)

    Faunce, Thomas A; Lexchin, Joel

    2007-01-01

    'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines. PMID:17543113

  8. Teaching about American Federal Democracy.

    Science.gov (United States)

    Schechter, Stephen L., Ed.

    Ten essays discuss federal democracy, the form of government of the United States. The first essay discusses the origins of American federalism. The second examines why we have a federal system, the functions federalism serves, and the consequences of federalism for the American political system. Federalism in the Constitution and constitutional…

  9. Fiscal federalism approach for controlling global environmental pollution

    International Nuclear Information System (INIS)

    Murty, M.N.

    1996-01-01

    It is found that optimal international carbon taxes are country specific and we can decompose a tax on a domestically produced carbon-intensive commodity into a revenue tax, a tax to control local atmospheric pollution and an international carbon tax. It shows that an institutional arrangement for the world economy similar to the fiscal federalism in the federal countries can be useful to internalize the global externalities of atmospheric pollution. 18 refs

  10. Differences in the volume of pharmaceutical advertisements between print general medical journals.

    Science.gov (United States)

    Gettings, Jennifer; O'Neill, Braden; Chokshi, Dave A; Colbert, James A; Gill, Peter; Lebovic, Gerald; Lexchin, Joel; Persaud, Navindra

    2014-01-01

    Pharmaceutical advertisements have been argued to provide revenue that medical journals require but they are intended to alter prescribing behaviour and they are known to include low quality information. We determined whether a difference exists in the current level of pharmaceutical advertising in print general medical journals, and we estimated the revenue generated from print pharmaceutical advertising. Six print general medical journals in Canada, the United States, and the United Kingdom were sampled between 2007 and 2012. The number of advertisements and other journal content in selected issues of the Canadian Medical Association Journal (CMAJ), Canadian Family Physician (CFP), Journal of the American Medical Association (JAMA), New England Journal of Medicine (NEJM), British Medical Journal (BMJ), and Lancet were determined. Revenue gained from pharmaceutical advertising was estimated using each journal's 2013 advertising price list. The two Canadian journals sampled (CMAJ, CFP) contained five times more advertisements than the two American journals (JAMA, NEJM), and two British journals (BMJ, Lancet) (padvertisements ranged from £0.025 million (for Lancet) to £3.8 million (for JAMA). The cost savings due to revenue from pharmaceutical advertising to each individual subscriber ranged from £0.02 (for Lancet) to £3.56 (for CFP) per issue. The volume of pharmaceutical advertisements differs between general medical journals, with the two Canadian journals sampled containing the most advertisements. International and temporal variations suggest that there is an opportunity for all general medical journals to reduce the number of pharmaceutical advertisements, explore other sources of revenue, and increase transparency regarding sources of revenue.

  11. Differences in the Volume of Pharmaceutical Advertisements between Print General Medical Journals

    Science.gov (United States)

    Gettings, Jennifer; O'Neill, Braden; Chokshi, Dave A.; Colbert, James A.; Gill, Peter; Lebovic, Gerald; Lexchin, Joel; Persaud, Navindra

    2014-01-01

    Background Pharmaceutical advertisements have been argued to provide revenue that medical journals require but they are intended to alter prescribing behaviour and they are known to include low quality information. We determined whether a difference exists in the current level of pharmaceutical advertising in print general medical journals, and we estimated the revenue generated from print pharmaceutical advertising. Methods Six print general medical journals in Canada, the United States, and the United Kingdom were sampled between 2007 and 2012. The number of advertisements and other journal content in selected issues of the Canadian Medical Association Journal (CMAJ), Canadian Family Physician (CFP), Journal of the American Medical Association (JAMA), New England Journal of Medicine (NEJM), British Medical Journal (BMJ), and Lancet were determined. Revenue gained from pharmaceutical advertising was estimated using each journal's 2013 advertising price list. Findings The two Canadian journals sampled (CMAJ, CFP) contained five times more advertisements than the two American journals (JAMA, NEJM), and two British journals (BMJ, Lancet) (padvertisements ranged from £0.025 million (for Lancet) to £3.8 million (for JAMA). The cost savings due to revenue from pharmaceutical advertising to each individual subscriber ranged from £0.02 (for Lancet) to £3.56 (for CFP) per issue. Conclusion The volume of pharmaceutical advertisements differs between general medical journals, with the two Canadian journals sampled containing the most advertisements. International and temporal variations suggest that there is an opportunity for all general medical journals to reduce the number of pharmaceutical advertisements, explore other sources of revenue, and increase transparency regarding sources of revenue. PMID:24416286

  12. Pharmaceutical solvates, hydrates and amorphous forms: A special emphasis on cocrystals.

    Science.gov (United States)

    Healy, Anne Marie; Worku, Zelalem Ayenew; Kumar, Dinesh; Madi, Atif M

    2017-08-01

    Active pharmaceutical ingredients (APIs) may exist in various solid forms, which can lead to differences in the intermolecular interactions, affecting the internal energy and enthalpy, and the degree of disorder, affecting the entropy. Differences in solid forms often lead to differences in thermodynamic parameters and physicochemical properties for example solubility, dissolution rate, stability and mechanical properties of APIs and excipients. Hence, solid forms of APIs play a vital role in drug discovery and development in the context of optimization of bioavailability, filing intellectual property rights and developing suitable manufacturing methods. In this review, the fundamental characteristics and trends observed for pharmaceutical hydrates, solvates and amorphous forms are presented, with special emphasis, due to their relative abundance, on pharmaceutical hydrates with single and two-component (i.e. cocrystal) host molecules. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. The effect of capital structure on the profitability of pharmaceutical companies the case of iran.

    Science.gov (United States)

    Mohammadzadeh, Mehdi; Rahimi, Farimah; Rahimi, Forough; Aarabi, Seyed Mohammad; Salamzadeh, Jamshid

    2013-01-01

    Funding combination is the most important issue for the companies while they know the amount of required capital. Companies should be careful regarding the appliance of financial providing methods compatible with the investment strategy of company and profitability. This study seeks to examine the relationship between the capital structure and the profitability of pharmaceutical companies in Iran. For this purpose, top 30 Iranian pharmaceutical companies defined as study samples and their financial data were gathered for the period of 2001-2010. In this study, the net margin profit and debts to asset ratio were used as indicators of profitability and capital structure, respectively and sales growth was used as a control variable. Results showed that there was significant negative relationship between the profitability and the capital structure which means that the pharmaceutical companies have established a Pecking Order Theory and the internal financing has led to more profitability.

  14. Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality.

    Science.gov (United States)

    O'Connor, Thomas F; Yu, Lawrence X; Lee, Sau L

    2016-07-25

    Issues in product quality have produced recalls and caused drug shortages in United States (U.S.) in the past few years. These quality issues were often due to outdated manufacturing technologies and equipment as well as lack of an effective quality management system. To ensure consistent supply of safe, effective and high-quality drug products available to the patients, the U.S. Food and Drug Administration (FDA) supports modernizing pharmaceutical manufacturing for improvements in product quality. Specifically, five new initiatives are proposed here to achieve this goal. They include: (i) advancing regulatory science for pharmaceutical manufacturing; (ii) establishing a public-private institute for pharmaceutical manufacturing innovation; (iii) creating incentives for investment in the technological upgrade of manufacturing processes and facilities; (iv) leveraging external expertise for regulatory quality assessment of emerging technologies; and (v) promoting the international harmonization of approaches for expediting the global adoption of emerging technologies. Published by Elsevier B.V.

  15. 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.

  16. Japanese practicing physicians' relationships with pharmaceutical representatives: a national survey.

    Directory of Open Access Journals (Sweden)

    Sayaka Saito

    Full Text Available BACKGROUND: Previous surveys on the relationship between physicians and pharmaceutical representatives (PRs have been of limited quality. The purpose of our survey of practicing physicians in Japan was to assess the extent of their involvement in pharmaceutical promotional activities, physician characteristics that predict such involvement, attitudes toward relationships with PRs, correlations between the extent of involvement and attitudes, and differences in the extent of involvement according to self-reported prescribing behaviors. METHODS AND FINDINGS: From January to March 2008, we conducted a national survey of 2621 practicing physicians in seven specialties: internal medicine, general surgery, orthopedic surgery, pediatrics, obstetrics-gynecology, psychiatry, and ophthalmology. The response rate was 54%. Most physicians met with PRs (98%, received drug samples (85% and stationery (96%, and participated in industry-sponsored continuing medical education (CME events at the workplace (80% and outside the workplace (93%. Half accepted meals outside the workplace (49% and financial subsidies to attend CME events (49%. Rules at the workplace banning both meetings with PRs and gifts predicted less involvement of physicians in promotional activities. Physicians valued information from PRs. They believed that they were unlikely to be influenced by promotional activities, but that their colleagues were more susceptible to such influence than themselves. They were divided about the appropriateness of low-value gifts. The extent of physician involvement in promotional activities was positively correlated with the attitudes that PRs are a valuable source of information and that gifts are appropriate. The extent of such involvement was higher among physicians who prefer to ask PRs for information when a new medication becomes available, physicians who are not satisfied with patient encounters ending only with advice, and physicians who prefer to

  17. Pharmaceutical strategy and innovation: an academics perspective.

    Science.gov (United States)

    Baxendale, Ian R; Hayward, John J; Ley, Steven V; Tranmer, Geoffrey K

    2007-06-01

    The pharmaceutical industry is under increasing pressure on many fronts, from investors requiring larger returns to consumer groups and health authorities demanding cheaper and safer drugs. It is also feeling additional pressure from the infringement upon its profit margins by generic drug producers. Many companies are aggressively pursuing outsourcing contracts in an attempt to counter many of the financial pressures and streamline their operations. At the same time, the productivity of the pharmaceutical industry at its science base is being questioned in terms of the number of products and the timeframes required for each company to deliver them to market. This has generated uncertainties regarding the current corporate strategies that have been adopted and the levels of innovation being demonstrated. In this essay we discuss these topics in the context of the global pharmaceutical market, investigating the basis for many of these issues and highlighting the hurdles the industry needs to overcome, especially as they relate to the chemical sciences.

  18. PRINTING TECHNIQUES: RECENT DEVELOPMENTS IN PHARMACEUTICAL TECHNOLOGY.

    Science.gov (United States)

    Jamroz, Witold; Kurek, Mateusz; Lyszczarz, Ewelina; Brniak, Witold; Jachowicz, Renata

    2017-05-01

    In the last few years there has been a huge progress in a development of printing techniques and their application in pharmaceutical sciences and particularly in the pharmaceutical technology. The variety of printing methods makes it necessary to systemize them, explain the principles of operation, and specify the possibilities of their use in pharmaceutical technology. This paper aims to review the printing techniques used in a drug development process. The growing interest in 2D and 3D printing methods results in continuously increasing number of scientific papers. Introduction of the first printed drug Spritam@ to the market seems to be a milestone of the 3D printing development. Thus, a particular aim of this review is to show the latest achievements of the researchers in the field of the printing medicines.

  19. 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...

  20. In Defense of Pharmaceutically Enhancing Human Morality.

    Science.gov (United States)

    Protopapadakis, Evangelos D

    2017-01-01

    I will discuss the prospect of pharmaceutically enhancing human morality and decision making in such a way as to eliminate morally unjustifiable choices and promote desirable ones. Our species in the relatively short period since it has emerged has enormously advanced in knowledge, science, and technical progress. When it comes to moral development, the distance it has covered is almost negligible. What if we could medically accelerate our moral development? What if we could once and for all render our species totally immune to certain vices? I will examine whether pharmaceutically intervening in human morality would compromise the autonomy of moral agents. I will argue that the argument from the autonomy of the moral agent is neither stable nor convincing. In the light of Kantian ethics we might consider moral enhancement by pharmaceutical means to be a perfect duty for moral agents.

  1. Marketing concepts for pharmaceutical service development.

    Science.gov (United States)

    Grauer, D W

    1981-02-01

    Marketing concepts as a mechanism to help pharmacy develop, communicate, and sell future pharmaceutical services to consumers are discussed. Pharmacy as a profession must define itself broadly to take advantage of future growth opportunities. These growth opportunities will be realized from unmet health-care needs and changing consumer life style trends and values. New services must therefore be oriented toward consumers (i.e., patients, health professionals, and third-party agencies) to gain acceptance. Dispensing and drug-knowledge-distribution pharmaceutical services are reviewed by a product life cycle analysis of sales profits versus time. A marketing mix for new pharmaceutical services is developed consisting of service, price, distribution, and promotion strategies. Marketing can encompass those key elements necessary to meet the organizational goals of pharmacy and provide a systematic, disciplined approach for presenting a new service to consumers.

  2. On radiation treatment of pharmaceutical products

    International Nuclear Information System (INIS)

    Zukov, V.; Mende, V.

    1976-01-01

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

  3. Dimensions of Modern Federalism.

    Science.gov (United States)

    Williams, Robert F.; And Others

    1995-01-01

    Encapsulates a series of brief essays exploring different aspects of modern federalism. Issues include further protection of individual rights extended through state constitutions and federalism and the world economy. Authors include Robert F. Williams, Earl H. Fry, and Daniel J. Elazar. (MJP)

  4. Review of recent applications of flow injection spectrophotometry to pharmaceutical analysis

    International Nuclear Information System (INIS)

    Tzanavaras, Paraskevas D.; Themelis, Demetrius G.

    2007-01-01

    Pharmaceutical analysis is one of the most important fields in analytical chemistry. The discovery of new drugs and the on-going update of international regulations for the safety and efficacy of pharmaceutical formulations demand the continuous development of new analytical methods. Inevitably, automation plays an important role, especially when a lot of samples have to be analyzed in the minimum of time. The present study reviews the applications of flow injection (FI) spectrophotometry to the determination of active pharmaceutical ingredients (APIs) in their respective formulations. However, the topic covered in this study is important not only to pharmaceutical analytical scientists. The principles, figures of merit and 'chemistry' of the presented methods can be of interest to bio-analytical and clinical chemists as well for the analysis of biological samples, to environmental analysts that study the up-to-date demand of the determination of the fate of pharmaceuticals in the environment and even to toxicologists and forensic scientists. This review covers scientific contributions published later than 2000. A variety of FI procedures based on homogeneous (direct UV measurements, colour-forming reactions, metal-drug interactions) and heterogeneous (optical sensors and solid-phase reactors) systems are discussed. A third section covers on-line sample pretreatment (solid-phase extraction, liquid-liquid extraction, on-line digestion, etc.)

  5. The effect of active learning methodologies on the teaching of pharmaceutical care in a Brazilian pharmacy faculty.

    Directory of Open Access Journals (Sweden)

    Alessandra R Mesquita

    Full Text Available In recent years, pharmacists have been involved in expanded patient care responsibilities, for example patient counseling in self-medication, medication review and pharmaceutical care, which require graduates to develop the necessary competences. Consequently, reorientation of pharmacy education has become necessary. As such, active learning strategies have been introduced into classrooms to increase problem-solving and critical thinking skills of students. The objective of this study was to evaluate the performance and perceptions of competency of students in a new pharmaceutical care course that uses active learning methodologies.This pharmaceutical care course was conducted in the first semester of 2014, in the Federal University of Sergipe. In the pharmaceutical care course, active learning methods were used, consisting of dialogic classroom expository, simulation and case studies. Student learning was evaluated using classroom tests and instruments that evaluated the perception of competency in pharmaceutical care practice. Furthermore, students' satisfaction with the course was evaluated.Thirty-three students completed the four evaluations used in the course (i.e., a discursive written exam, seminars, OSCE, and virtual patient; 25 were female (75.75%, and the median age was 23.43 (SD 2.82 years. The overall mean of student scores, in all evaluation methods was 7.97 (SD 0.59 on a scale of 0 to 10 points, and student performance on the virtual patient method was statistically superior to other methods. With respect to the perception of competency in pharmaceutical care practice, a comparison of pre- and post-test scores revealed statistically significant improvement for all evaluated competences. At the end of the semester, the students presented positive opinions of the pharmaceutical care course.The results suggest that an active learning course can enhance the learning of pharmaceutical care competences. In future studies it will be

  6. The effect of active learning methodologies on the teaching of pharmaceutical care in a Brazilian pharmacy faculty.

    Science.gov (United States)

    Mesquita, Alessandra R; Souza, Werlissandra M; Boaventura, Thays C; Barros, Izadora M C; Antoniolli, Angelo R; Silva, Wellington B; Lyra Júnior, Divaldo P

    2015-01-01

    In recent years, pharmacists have been involved in expanded patient care responsibilities, for example patient counseling in self-medication, medication review and pharmaceutical care, which require graduates to develop the necessary competences. Consequently, reorientation of pharmacy education has become necessary. As such, active learning strategies have been introduced into classrooms to increase problem-solving and critical thinking skills of students. The objective of this study was to evaluate the performance and perceptions of competency of students in a new pharmaceutical care course that uses active learning methodologies. This pharmaceutical care course was conducted in the first semester of 2014, in the Federal University of Sergipe. In the pharmaceutical care course, active learning methods were used, consisting of dialogic classroom expository, simulation and case studies. Student learning was evaluated using classroom tests and instruments that evaluated the perception of competency in pharmaceutical care practice. Furthermore, students' satisfaction with the course was evaluated. Thirty-three students completed the four evaluations used in the course (i.e., a discursive written exam, seminars, OSCE, and virtual patient); 25 were female (75.75%), and the median age was 23.43 (SD 2.82) years. The overall mean of student scores, in all evaluation methods was 7.97 (SD 0.59) on a scale of 0 to 10 points, and student performance on the virtual patient method was statistically superior to other methods. With respect to the perception of competency in pharmaceutical care practice, a comparison of pre- and post-test scores revealed statistically significant improvement for all evaluated competences. At the end of the semester, the students presented positive opinions of the pharmaceutical care course. The results suggest that an active learning course can enhance the learning of pharmaceutical care competences. In future studies it will be necessary to

  7. Using compression calorimetry to characterize powder compaction behavior of pharmaceutical materials.

    Science.gov (United States)

    Buckner, Ira S; Friedman, Ross A; Wurster, Dale Eric

    2010-02-01

    The process by which pharmaceutical powders are compressed into cohesive compacts or tablets has been studied using a compression calorimeter. Relating the various thermodynamic results to relevant physical processes has been emphasized. Work, heat, and internal energy change values have been determined with the compression calorimeter for common pharmaceutical materials. A framework of equations has been proposed relating the physical processes of friction, reversible deformation, irreversible deformation, and inter-particle bonding to the compression calorimetry values. The results indicate that irreversible deformation dominated many of the thermodynamic values, especially the net internal energy change following the compression-decompression cycle. The relationships between the net work and the net heat from the complete cycle were very clear indicators of predominating deformation mechanisms. Likewise, the ratio of energy stored as internal energy to the initial work input distinguished the materials according to their brittle or plastic deformation tendencies. (c) 2009 Wiley-Liss, Inc. and the American Pharmacists Association.

  8. Pharmaceutical care: the PCNE definition 2013.

    Science.gov (United States)

    Allemann, Samuel S; van Mil, J W Foppe; Botermann, Lea; Berger, Karin; Griese, Nina; Hersberger, Kurt E

    2014-06-01

    Twenty-three years after Hepler and Strand published their well-known definition of Pharmaceutical Care (PhC), confusion remains about what the term includes and how to differentiate it from other terms. The board of the Pharmaceutical Care Network Europe (PCNE) felt the need to redefine PhC and to answer the question: "What is Pharmaceutical Care in 2013". The aims of this paper were to review existing definitions of PhC and to describe the process of developing a redefined definition. A literature search was conducted in the MEDLINE database (1964-January 2013). Keywords included "Pharmaceutical Care", "Medication (Therapy) Management", "Medicine Management", and "Pharmacist Care" in the title or abstract together with the term "defin*". To ease comparison between definitions, we developed a standardised syntax to paraphrase the definitions. During a dedicated meeting, a moderated discussion about the definition of PhC was organised. The initial literature search produced 186 hits, with eight unique PhC definitions. Hand searching identified a further 11 unique definitions. These 19 definitions were paraphrased using the standardised syntax (provider, recipient, subject, outcome, activities). Fourteen members of PCNE and 10 additional experts attended the moderated discussion. Working groups of increasing size developed intermediate definitions, which had similarities and differences to those retrieved in the literature search. At the end of the session, participants reached a consensus on a "PCNE definition of Pharmaceutical Care" reading: "Pharmaceutical Care is the pharmacist's contribution to the care of individuals in order to optimize medicines use and improve health outcomes". It was possible to paraphrase definitions of PhC using a standardised syntax focusing on the provider, recipient, subject, outcomes, and activities included in PhC practice. During a one-day workshop, experts in PhC research agreed on a definition, intended to be applicable for the

  9. Foreign Languages: Workforce Planning Could Help Address Staffing and Proficiency Shortfalls. Testimony before the Subcommittee on International Security, Proliferation, and Federal Services, Committee on Governmental Affairs, U.S. Senate.

    Science.gov (United States)

    Westin, Susan S.

    This statement examines the nature and impact of foreign language proficiency and personnel shortages in the Army, State Department, Central Intelligence Agency, and Federal Bureau of Investigation (FBI), discussing strategies used to address these shortages and efforts made to address current and projected shortages. All four agencies reported…

  10. District of Columbia Public Education: Agencies Have Enhanced Internal Controls over Federal Payments for School Improvement, but More Consistent Monitoring Needed. Report to Congressional Requesters. GAO-11-16

    Science.gov (United States)

    Ashby, Cornelia M.

    2010-01-01

    Between fiscal years 2004 and 2009, Congress appropriated nearly $190 million in federal payments for school improvement to the District of Columbia (D.C.). This includes $85 million to the state education office--currently the Office of the State Superintendent of Education (OSSE)--to expand public charter schools and $105 million to D.C. Public…

  11. Agreement of 13 December 1991 between the Republic of Argentina, the Federative Republic of Brazil, the Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials and the International Atomic Energy Agency for the applications of safeguards

    International Nuclear Information System (INIS)

    1998-01-01

    The document reproduces the text of an Agreement by exchange of letters with the Federative Republic of Brazil in connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Caribbean. The agreement reflected in the Exchange of Letters was approved by the Board of Governors on 10 June 1997 and entered into force on that date

  12. 76 FR 20690 - Preparation for International Conference on Harmonization Steering Committee and Expert Working...

    Science.gov (United States)

    2011-04-13

    ... ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries... Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of.../industry project to improve, through harmonization, the efficiency of the process for developing and...

  13. 75 FR 57803 - Preparation for International Conference on Harmonisation Steering Committee and Expert Working...

    Science.gov (United States)

    2010-09-22

    ... the European Commission; the European Federation of Pharmaceutical Industries Associations; the... Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of... ICH was established in 1990 as a joint regulatory/industry project to improve, through harmonization...

  14. 75 FR 17148 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Science.gov (United States)

    2010-04-05

    .... The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries... Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of... recent years, many important initiatives have been undertaken by regulatory authorities and industry...

  15. Diagnostic and therapeutic radio pharmaceutical capsules

    International Nuclear Information System (INIS)

    Haney, T.A.; Wedeking, P.W.; Morcos, N.A.

    1981-01-01

    An improved pharmaceutical radioactive capsule consisting of a non-toxic, water soluble material adapted to being ingested and rapidly disintegrating on contact with fluids of the gastro-intestinal tract is described. Each capsule is provided with filler material supporting a pharmaceutically useful radioactive compound absorbable from the gastro-intestinal tract. The capsule is preferably of gelatin, methyl cellulose or polyvinyl alcohol and the filler is a polyethylene glycol. The radioactive compound may be iodine e.g. sodium radioiodide I-131 or 123. The capsule may also contain a reducing agent e.g. sodium thiosulphate, sulphite, or bisulphite. (author)

  16. 75 FR 38999 - Federal Perkins Loan Program: Federal Family Education Loan Program and William D. Ford Federal...

    Science.gov (United States)

    2010-07-07

    ..., or Direct Loan Program, excluding PLUS loans made under the FFEL and Direct Loan Programs to parents... that repaid a parent PLUS loan. Employee means an individual who, under Federal tax law, is considered... Internal Revenue Code. Involuntary separation due to misconduct means termination from [[Page 39001...

  17. 26 CFR 31.6011(a)-3 - Returns under Federal Unemployment Tax Act.

    Science.gov (United States)

    2010-04-01

    ... 26 Internal Revenue 15 2010-04-01 2010-04-01 false Returns under Federal Unemployment Tax Act. 31... Provisions of Subtitle F, Internal Revenue Code of 1954) § 31.6011(a)-3 Returns under Federal Unemployment Tax Act. (a) Requirement. Every person shall make a return of tax under the Federal Unemployment Tax...

  18. 26 CFR 31.6402(a)-3 - Refund of Federal unemployment tax.

    Science.gov (United States)

    2010-04-01

    ... 26 Internal Revenue 15 2010-04-01 2010-04-01 false Refund of Federal unemployment tax. 31.6402(a... Provisions of Subtitle F, Internal Revenue Code of 1954) § 31.6402(a)-3 Refund of Federal unemployment tax... 3301 of the Federal Unemployment Tax Act or a corresponding provision of prior law, or (b) Interest...

  19. A risk-based auditing process for pharmaceutical manufacturers.

    Science.gov (United States)

    Vargo, Susan; Dana, Bob; Rangavajhula, Vijaya; Rönninger, Stephan

    2014-01-01

    The purpose of this article is to share ideas on developing a risk-based model for the scheduling of audits (both internal and external). Audits are a key element of a manufacturer's quality system and provide an independent means of evaluating the manufacturer's or the supplier/vendor's compliance status. Suggestions for risk-based scheduling approaches are discussed in the article. Pharmaceutical manufacturers are required to establish and implement a quality system. The quality system is an organizational structure defining responsibilities, procedures, processes, and resources that the manufacturer has established to ensure quality throughout the manufacturing process. Audits are a component of the manufacturer's quality system and provide a systematic and an independent means of evaluating the manufacturer's overall quality system and compliance status. Audits are performed at defined intervals for a specified duration. The intention of the audit process is to focus on key areas within the quality system and may not cover all relevant areas during each audit. In this article, the authors provide suggestions for risk-based scheduling approaches to aid pharmaceutical manufacturers in identifying the key focus areas for an audit.

  20. Pharmaceutical cost-containment policies and sustainability: recent Irish experience.

    Science.gov (United States)

    Kenneally, Martin; Walshe, Valerie

    2012-01-01

    Our objective is to review and assess the main pharmaceutical cost-containment policies used in Ireland in recent years, and to highlight how a policy that improved fiscal sustainability but worsened economic sustainability could have improved both if an option-based approach was implemented. The main public pharmaceutical cost-containment policy measures including reducing the ex-factory price of drugs, pharmacy dispensing fees and community drug scheme coverage, and increasing patient copayments are outlined along with the resulting savings. We quantify the cost implications of a new policy that restricts the entitlement to free prescription drugs of persons older than 70 years and propose an alternative option-based policy that reduces the total cost to both the state and the patient. This set of policy measures reduced public spending on community drugs by an estimated €380m in 2011. The policy restricting free prescription drugs for persons older than 70 years, though effective in reducing public cost, increased the total cost of the drugs supplied. The policy-induced cost increase stems from a fees anomaly between the two main community drugs schemes which is circumvented by our alternative option-based policy. Our findings highlight the need for policymakers, even when absorbed with reducing cost, to design cost-containment policies that are both fiscally and economically sustainable. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.