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 Price Discrimination: The Pharmaceutical Industry

    NARCIS (Netherlands)

    F.T. Schut (Erik); P.A.G. van Bergeijk (Peter)

    1986-01-01

    textabstractIt is generally asserted that price discrimination is a common feature of the international pharmaceutical market, resulting in unnecessarily high medical costs to developing countries, since it is pharmaceuticals that are the largest component of their health care expenditures. However,

  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. 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.

  7. 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…

  8. [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.

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. International Conference on Harmonisation; Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals; availability. Notice.

    Science.gov (United States)

    2006-04-13

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S8 Immunotoxicity Studies for Human 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 provides recommendations on nonclinical testing approaches to identify compounds that have the potential to be immunotoxic and guidance on a weight-of-evidence decision making approach for immunotoxicity testing. The guidance is intended to provide recommendations on nonclinical testing for immunotoxicity induced by human pharmaceuticals. The guidance applies to unintended immunosuppression and immunoenhancement, excluding allergenicity or drug-specific autoimmunity.

  15. International pharmaceutical social risk regulation: An ethical perspective.

    Science.gov (United States)

    Gordon, Cameron

    2011-03-01

    Pharmaceutical production and distribution constitute big business. For the companies the rewards can be substantial. Rates of return on drug company investments tend to be higher than many other manufacturing enterprises. But reward is only one side of the story. There is also the issue of social risk, the focus of this article. Social risk for pharmaceutical production is especially pronounced. An ineffective or, worse, dangerous drug, can have dire consequences for the population at large. For this reason, there is elaborate government regulation and oversight of drug safety and risk. These systems, especially in the US and Europe, will be the main focus of this paper. The two systems will be described, and then compared and contrasted in terms of their framing of social risk and actions governments take to limit it. Systems elsewhere, especially in the developing world, are increasing in relative importance and these will be briefly discussed as well. Ethical issues that have arisen in these various systems will be surfaced and analysed. The paper will close with some conclusions and suggestions for further research.

  16. 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.

  17. 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. PMID:25342901

  18. 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.

  19. The Russian Federation and the International Climate Change Regime

    OpenAIRE

    GORDEEVA, Yelena

    2014-01-01

    Although the Russian Federation (RF) is one of the key players in the global climate change politics, the country is rather discreet in binding itself with new international climate obligations. Often the country is criticized for its weak national climate change law and policy. To provide current context as regards the status of Russian climate change mitigation efforts, this article analyzes the RF's climate law and policy at the domestic and international levels. It does so by first invest...

  20. 78 FR 26375 - Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship...

    Science.gov (United States)

    2013-05-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship..., Implementing, and Sustaining a Culture of Quality AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

  1. 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

  2. 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

  3. Transition of care: A set of pharmaceutical interventions improves hospital discharge prescriptions from an internal medicine ward.

    Science.gov (United States)

    Neeman, Marine; Dobrinas, Maria; Maurer, Sophie; Tagan, Damien; Sautebin, Annelore; Blanc, Anne-Laure; Widmer, Nicolas

    2017-03-01

    Continuity of care between hospitals and community pharmacies needs to be improved to ensure medication safety. This study aimed to evaluate whether a set of pharmaceutical interventions to prepare hospital discharge facilitates the transition of care. This study took place in the internal medicine ward and in surrounding community pharmacies. The intervention group's patients underwent a set of pharmaceutical interventions during their hospital stay: medication reconciliation at admission, medication review, and discharge planning. The two groups were compared with regards to: number of community pharmacist interventions, time spent on discharge prescriptions, and number of treatment changes. Comparison between the groups showed a much lower (77% lower) number of community pharmacist interventions per discharge prescription in the intervention (n=54 patients) compared to the control group (n=64 patients): 6.9 versus 1.6 interventions, respectively (pprescriptions; less interventions requiring a telephone call to a hospital physician. The number of medication changes at different steps was also significantly lower in the intervention group: 40% fewer (pprescriptions. Altogether, this improves continuity of care. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  4. 76 FR 65210 - Certain Products and Pharmaceutical Compositions Containing Recombinant Human Erythropoetin...

    Science.gov (United States)

    2011-10-20

    ... From the Federal Register Online via the Government Publishing Office INTERNATIONAL TRADE COMMISSION Certain Products and Pharmaceutical Compositions Containing Recombinant Human Erythropoetin... sale within the United States after importation of certain products and pharmaceutical compositions...

  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. Adaption strategy of regional department of international pharmaceutical company in a new foreign market

    Directory of Open Access Journals (Sweden)

    Uvarov V.V.

    2012-06-01

    Full Text Available In a new foreign market strategy of adaptation of the regional department of an international pharmaceutical company has its own peculiarities that arise from the specifics of the pharmaceutical market. In article the strategy to adapt to the new market has been discussed, as conceived plan for use of any of options available to the regional office. This range of options for adaptation will vary depending on the level of competition in different segments of the new market. In his article the author, based on the specifics of the pharmaceutical market, examines the impact of factors such as «competition» to choose a set of possibilities to adapt the regional office. The article is classified in the new market segments based on consumer awareness and choice in the way of treatment. In his article, the author discusses the different feature sets for adaptation the regional branch of pharmaceutical company in the new market. Conclusion: To achieve the desired level of adaptation to the new market under the current conditions (when the balance of power in favor of an informed buyer and seller competition, the regional office has to acquire and use every opportunity not only to meet but to exceed customer expectations

  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. 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.

  10. 78 FR 52532 - Exposure Draft-Standards for Internal Control in the Federal Government

    Science.gov (United States)

    2013-08-23

    ... GOVERNMENT ACCOUNTABILITY OFFICE Exposure Draft--Standards for Internal Control in the Federal... to the Standards for Internal Control in the Federal Government, known as the ``Green Book,'' under... Exposure Draft update to the Standards for Internal Control in the Federal Government reflect major...

  11. 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.

  12. 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.

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

    Science.gov (United States)

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

    2015-01-01

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

  14. 5 CFR 315.712 - Conversion based on service as a Federal Career Intern.

    Science.gov (United States)

    2010-01-01

    ... Career Intern. 315.712 Section 315.712 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL... Employment From Other Types of Employment § 315.712 Conversion based on service as a Federal Career Intern... employment, a career intern who: (1) Has successfully completed a Federal Career Intern Program, under § 213...

  15. 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, ...

  16. 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.

  17. Quality control of drugs. Certification scheme on the quality of pharmaceutical products moving in international commerce.

    Science.gov (United States)

    1979-01-01

    In an effort to ensure a desirable level of quality control of drugs in international commerce, the 28th World Health Assembly recommended, in its resolution WHA28.65, that Member States apply the requirements for "Good Practices in the Manufacture and Quality Control of Drugs" and participate in the Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce. Since the publication of the 1st list 13 countries (Austria, Congo, Denmark, El Salvador, India, Iran, Israel, Liberia, Swaziland, Thailand, Tunisia, United Republic of Tanzania, and Zaire) have informed the World Health Organization of their agreement to participate in the Certification Scheme, and the texts of their replies are included here.

  18. 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

  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. 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...

  1. Current Challenges and Potential Opportunities for the Pharmaceutical Sciences to Make Global Impact: An FIP Perspective

    NARCIS (Netherlands)

    Tucker, Geoffrey; DeSilva, Binodh; Dressman, Jennifer; Ito, Michiho; Kumamoto, Takuya; Mager, Don; Mahler, Hanns-Christian; Maitland-van der Zee, Anke H.; Pauletti, Giovanni M.; Sasaki, Hitoshi; Shah, Vinod; Tang, Daniel; Ward, Michael

    2016-01-01

    The chairs of each of the 8 Special Interest Groups of the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation have compiled opinions with regard to major challenges for the pharmaceutical sciences over the next 5-10 years. Areas covered are drug design and discovery,

  2. INTERNATIONAL DIABETES FEDERATION CONSENSUS ON DEFINITION OF THE METABOLIC SYNDROME: FACTS AND COMMENTS

    Directory of Open Access Journals (Sweden)

    M. N. Mamedov

    2009-01-01

    Full Text Available International Diabetes Federation consensus, devoted to definition of the metabolic syndrome was published in 2006. The main statements of this document are presented and commented.

  3. 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

  4. 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)

  5. 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.

  6. 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).

  7. Internal Auditing in Federal, State, and Local Governments (Part II).

    Science.gov (United States)

    Knight, Susan; Wilson, Guy

    1981-01-01

    This second part of an annotated bibliography of reports, books, and journal articles concerned with internal auditing in government contexts reviews the available literature for an understanding of the types of internal audit, methods and practices, and other facets. (FM)

  8. Govt. Pubs.: Internal Auditing in Federal, State, and Local Governments.

    Science.gov (United States)

    Knight, Susan; Wilson, Guy

    1980-01-01

    Lists reports, monographs, and journal articles of the last five years that deal with internal auditing at various governmental levels, including the growth of the internal audit, the development of guidelines, current practices, types of audit, and current issues. (FM)

  9. 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.

  10. Pharmaceutical patents and some international trade issues: Canada, the United States, and NAFTA.

    Science.gov (United States)

    Tancer, R S

    1993-01-01

    This paper traces the evolution of a more aggressive US policy for the protection of the intellectual property rights of its citizens, individual and corporate, who do business aborad. It focuses on the pharmaceutical industry and, in particular, the harmonization of conflicting US and Canadian policies. In reconciling these policy differences, the United States unilaterally applied relatively new procedures authorized under section 301 and Special 301 of its trade laws. It also utilized the bilateral dispute mechanism mandating cooperation "in the Uruguay Round ... to improve protection of intellectual property," as provided in the Canada-United States Free Trade Agreement. These efforts were successful; Canada amended its patent law in 1993 to conform to current international practices. These changes were incorporated into the North American Free Trade Agreement (NAFTA), making it a state-of-the-art example of the protection of intellectual property rights. The intellectual property chapter of NAFTA will serve as the model for US intellectual property rights negotiations for the foreseeable future.

  11. 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)

  12. 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...

  13. The international economic position of the Federal Republic of Germany

    International Nuclear Information System (INIS)

    Strube, J.

    1993-01-01

    In spite of a clear increase in the domestic demands the German industry has been investing about 175 billion marks abroad during the past decade. These investments abroad have not necessarily been undermining the economic status of the Federal Republic of Germany but can rather be explained by the importance of the market proximity to foreign locations. In the first place, the German industry's foreign investments reveal the efficiency and competiveness of the companies which have been succeeding in establishing themselves on the markets in Europe and outside of Europe and in qualifying the domestic industry for the world market. (orig.) [de

  14. 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...

  15. 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

  16. 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

    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-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...

  17. 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

  18. 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

  19. 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...

  20. 76 FR 78258 - Valeant Pharmaceuticals International, Inc.; Analysis of Agreement Containing Consent Order to...

    Science.gov (United States)

    2011-12-16

    ... Dermatologics from Janssen, a Johnson & Johnson company, in a transaction valued at approximately $345 million... Dermatologics division of Janssen Pharmaceuticals, Inc. (``Janssen''), a wholly owned subsidiary of Johnson & Johnson. The proposed Consent Agreement has been placed on the public record for thirty (30) days for...

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

    Science.gov (United States)

    Rudd, Murray A; Ankley, Gerald T; Boxall, Alistair B A; Brooks, Bryan W

    2014-10-01

    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 is needed to inform regulatory and policy responses that address potential risks. A recent "big questions" exercise with participants largely from North America identified 22 important research questions around the risks of PPCP in the environment that would help address the most pressing knowledge gaps over the next decade. To expand that analysis, we developed a survey that was completed by 535 environmental scientists from 57 countries, of whom 49% identified environmental or analytical chemistry as their primary disciplinary background. They ranked the 22 original research questions and submitted 171 additional candidate research questions they felt were also of high priority. Of the original questions, the 3 perceived to be of highest importance related to: 1) the effects of long-term exposure to low concentrations of PPCP mixtures on nontarget organisms, 2) effluent treatment methods that can reduce the effects of PPCPs in the environment while not increasing the toxicity of whole effluents, and 3) the assessment of the environmental risks of metabolites and environmental transformation products of PPCPs. A question regarding the role of cultural perspectives in PPCP risk assessment was ranked as the lowest priority. There were significant differences in research orientation between scientists who completed English and Chinese language versions of the survey. We found that the Chinese respondents were strongly orientated to issues of managing risk profiles, effluent treatment, residue bioavailability, and regional assessment. Among English language respondents, further differences in research orientation were associated with respondents' level of consistency when ranking the survey

  3. 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

  4. 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.

  5. Civil Legislation and International Treaties: The Interaction within the Legal System of the Russian Federation

    OpenAIRE

    Eremenko, Alexander

    2010-01-01

    The article deals with analysis of theoretical aspects of the category of “international treaties” from the point of view of their place in the hierarchical structure of the legal system of the Russian Federation and their correlation to the civil legislation. The author describes the synthetic models of correlation of international treaties and national legislation and formulates these models as concepts of “super-nationalism”, “sub-constitutionalism”, “super-legalism” and “inter-legalism”....

  6. [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.

  7. DEVELOPMENT STRATEGY OF INTERNATIONAL HUBS BASED ON REGIONAL AIRPORTS IN RUSSIAN FEDERATION

    Directory of Open Access Journals (Sweden)

    I. A. Belavintsev

    2014-01-01

    Full Text Available The article deals with an important area of development of the civil aviation airports network and air transport route networks in the Russian Federation and is based on priority development of the largest airport hubs considering the specific characteristics of the current status and further development of internal air transport market and subsidy programs of the Russian regional aircraft.

  8. 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…

  9. 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…

  10. 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

  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. Could international compulsory licensing reconcile tiered pricing of pharmaceuticals with the right to health?

    Science.gov (United States)

    Ooms, Gorik; Forman, Lisa; Williams, Owain D; Hill, Peter S

    2014-12-18

    The heads of the Global Fund and the GAVI Alliance have recently promoted the idea of an international tiered pricing framework for medicines, despite objections from civil society groups who fear that this would reduce the leeway for compulsory licenses and generic competition. This paper explores the extent to which an international tiered pricing framework and the present leeway for compulsory licensing can be reconciled, using the perspective of the right to health as defined in international human rights law. We explore the practical feasibility of an international tiered pricing and compulsory licensing framework governed by the World Health Organization. We use two simple benchmarks to compare the relative affordability of medicines for governments - average income and burden of disease - to illustrate how voluntary tiered pricing practice fails to make medicines affordable enough for low and middle income countries (if compared with the financial burden of the same medicines for high income countries), and when and where international compulsory licenses should be issued in order to allow governments to comply with their obligations to realize the right to health. An international tiered pricing and compulsory licensing framework based on average income and burden of disease could ease the tension between governments' human rights obligation to provide medicines and governments' trade obligation to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights.

  13. International Federation for Emergency Medicine model curriculum for medical student education in emergency medicine.

    Science.gov (United States)

    Hobgood, Cherri; Anantharaman, Venkataraman; Bandiera, Glen; Cameron, Peter; Halpern, Pinchas; Holliman, James; Jouriles, Nicholas; Kilroy, Darren; Mulligan, Terrence; Singer, Andrew

    2010-10-01

    Currently, there is no internationally recognised, standard curriculum that defines the basic minimum standards for emergency medicine education. To address this, the International Federation for Emergency Medicine convened a committee of international experts in emergency medicine and international emergency medicine development to outline a global curriculum for medical students in emergency medicine. This curriculum document represents the consensus of recommendations by this committee. The curriculum is designed with a focus on the basic minimum emergency medicine educational content that any medical school should be delivering to its students during their undergraduate years of training. The content is relevant not just for communities with mature emergency medicine systems, but also for developing nations or for nations seeking to expand emergency medicine within current educational structures. It is anticipated that there will be wide variability in how this curriculum is implemented and taught, reflecting the existing educational milieu, the resources available and the goals of the institutions' educational leadership.

  14. 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.

  15. 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.

  16. Lessons from international experience in controlling pharmaceutical expenditure. I: Influencing patients.

    OpenAIRE

    Freemantle, N.; Bloor, K.

    1996-01-01

    This is the first of three papers to review international policies to control spending on drugs and improve the efficiency of drug use. Policies can target three main groups: patients, prescribing doctors, and the drugs industry. In this paper we examine policies aimed at patients, particularly restrictions on reimbursement (such as prescription charges). Rigorous experimental and quasi-experimental studies suggest that policies to limit the level of reimbursement of drugs reduce the use of e...

  17. Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.

    Science.gov (United States)

    Basile, Edward M; Tolomeo, Deborah; Gluck, Elizabeth

    2009-01-01

    With no communication to industry except court filings in United States v. Undetermined Quantities of Boxes of Articles of Device (Shelhigh) and a draft guidance document, the Food and Drug Administration (FDA) has articulated new policies regarding export of pharmaceutical products and medical devices. FDA's departure from its historic interpretation of the export provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) significantly limits the ability of manufacturers to export misbranded drugs and medical devices that FDA deems "adulterated," contrary to the plain language and legislative intent of the FDCA. To further exacerbate the issue, FDA has begun to implement these policies without the notice-and-comment rulemaking required by the Administrative Procedures Act (APA), but rather through an enforcement proceeding brought in the United States District Court for the District of New Jersey. In a letter opinion, the District Court prevented the export of Current Good Manufacturing Practices (CGMP) --adulterated medical devices that complied with FDCA Section 801(e)(1), at least as historically interpreted by FDA. The purpose of this article is to review the history of FDA's export policies for pharmaceuticals and medical devices, particularly those aspects of the export policies that are affected by FDA's recent change in position. Three changes in FDA's interpretation of the export provisions of the FDCA will be addressed: 1) unapproved devices that a manufacturer reasonably believes are eligible for Section 510(k) clearance may no longer be exported under Section 801(e) and now must be exported under Section 802, in substantial compliance with Current CGMP; 2) adulterated devices and misbranded drugs can only be exported if the foreign purchaser's specifications cause the product to be adulterated; and 3) an article may not be exported if a like article has ever been sold or offered for sale in domestic commerce. FDA's new interpretations of FDCA

  18. 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...

  19. Internal Flow and Near-Orifice Spray Visualisations of a Model Pharmaceutical Pressurised Metered Dose Inhaler

    International Nuclear Information System (INIS)

    Versteeg, H K; Hargrave, G K; Kirby, M

    2006-01-01

    The pressurised Metered Dose Inhaler (pMDI) has become the most prescribed drug delivery system for treating the respiratory diseases. However, the spray generation mechanism of these devices has not been extensively researched and there is very little information regarding the two-phase fluid dynamics associated with pre-atomisation inside the valve stem. The aim of the work presented in this paper is to provide high-quality, time-resolved imaging of the internal flow structures of pMDIs in an attempt to link the characteristics of the internal flow to external spray atomization processes. Visualisations of the aerosols in the near-orifice region findings from previous studies of commercial pMDIs and showed the following characteristics: (i) start-up transient (ii) fully developed spray with slow spray density variations and (iii) rapid spray density pulsations with large droplet production. The results clearly highlighted the potential of optical diagnostics in the development of improved accounts of the state of the flow inside a pMDI valve and its relationship with drop formation

  20. 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.

  1. 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.

  2. The Russian Federation and the International Space Station: Leveraging Russian Space Strengths to Control its Missile Technology Proliferation

    National Research Council Canada - National Science Library

    Gloss, Lawrence

    1998-01-01

    .... This thesis discusses how a partnership with the Russian Federation and Russian Space Agency within the International Space Station can both act as an incentive for the Russians to prevent illicit...

  3. 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.

  4. 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.

  5. Evaluating an online pharmaceutical education system for pharmacy interns in critical care settings.

    Science.gov (United States)

    Yeh, Yu-Ting; Chen, Hsiang-Yin; Cheng, Kuei-Ju; Hou, Ssu-An; Yen, Yu-Hsuan; Liu, Chien-Tsai

    2014-02-01

    Incorporating electronic learning (eLearning) system into professional experimental programs such as pharmacy internships is a challenge. However, none of the current systems can fully support the unique needs of clinical pharmacy internship. In this study we enhanced a commercial eLearning system for clinical pharmacy internship (The Clinical Pharmacy Internship eLearning System, CPIES). The KAP questionnaire was used to evaluate the performance of group A with the traditional teaching model and group B with the CPIES teaching model. The CPIES teaching model showed significant improvement in interns' knowledge and practice (p = 0.002 and 0.031, respectively). The traditional teaching model only demonstrated significant improvement in practice (p = 0.011). Moreover, professionalism, such as attitudes on cooperating with other health professionals, is developed by learning from a good mentor. The on-line teaching and traditional teaching methods should undoubtedly be blended in a complete teaching model in order to improve learners' professional knowledge, facilitate correct attitude, and influence good practice. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  6. 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.

  7. 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.

  8. 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

  9. International Federation for Emergency Medicine model curriculum for emergency medicine specialists

    Directory of Open Access Journals (Sweden)

    Cherri Hobgood

    2011-06-01

    Full Text Available To meet a critical and growing need for emergency physicians and emergency medicine resources worldwide, physicians must be trained to deliver time-sensitive interventions and lifesaving emergency care. Currently, there is no globally recognized, standard curriculum that defines the basic minimum standards for specialist trainees in emergency medicine. To address this deficit, the International Federation for Emergency Medicine (IFEM convened a committee of international physicians, health professionals, and other experts in emergency medicine and international emergency medicine development to outline a curriculum for training of specialists in emergency medicine. This curriculum document represents the consensus of recommendations by this committee. The curriculum is designed to provide a framework for educational programs in emergency medicine. The focus is on the basic minimum emergency medicine educational content that any emergency medicine physician specialist should be prepared to deliver on completion of a training program. It is designed not to be prescriptive but to assist educators and emergency medicine leadership to advance physician education in basic emergency medicine no matter the training venue. The content of this curriculum is relevant not just for communities with mature emergency medicine systems but in particular for developing nations or for nations seeking to expand emergency medicine within the current educational structure. We anticipate that there will be wide variability in how this curriculum is implemented and taught. This variability will reflect the existing educational milieu, the resources available, and the goals of the institutions’ educational leadership with regard to the training of emergency medicine specialists.

  10. 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.

  11. 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

  12. 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

  13. 76 FR 54287 - Notice of Intent To Release Federally-Obligated Airport Properties, Tampa International Airport...

    Science.gov (United States)

    2011-08-31

    ...-aeronautical use. The property will be released of its federal obligations for fair market value. The fair... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Notice of Intent To Release Federally-Obligated Airport Properties, Tampa...

  14. 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.

  15. International Federation for Emergency Medicine Model Curriculum for Emergency Medicine Specialists.

    Science.gov (United States)

    Hobgood, Cherri; Anantharaman, Venkataraman; Bandiera, Glen; Cameron, Peter; Halpern, Pinchas; Holliman, C James; Jouriles, Nicholas; Kilroy, Darren; Mulligan, Terrence; Singer, Andrew

    2011-10-01

    To meet a critical and growing need for emergency physicians and emergency medicine resources worldwide, physicians must be trained to deliver time-sensitive interventions and lifesaving emergency care. Currently, there is no globally recognized, standard curriculum that defines the basic minimum standards for specialist trainees in emergency medicine. To address this deficit, the International Federation for Emergency Medicine convened a committee of international physicians, health professionals and other experts in emergency medicine and international emergency medicine development to outline a curriculum for training of specialists in emergency medicine. This curriculum document represents the consensus of recommendations by this committee. The curriculum is designed to provide a framework for educational programmes in emergency medicine. The focus is on the basic minimum emergency medicine educational content that any emergency medicine physician specialist should be prepared to deliver on completion of a training programme. It is designed not to be prescriptive but to assist educators and emergency medicine leadership to advance physician education in basic emergency medicine no matter the training venue. The content of this curriculum is relevant not just for communities with mature emergency medicine systems, but in particular for developing nations or for nations seeking to expand emergency medicine within the current educational structure. We anticipate that there will be wide variability in how this curriculum is implemented and taught. This variability will reflect the existing educational milieu, the resources available, and the goals of the institutions' educational leadership with regard to the training of emergency medicine specialists. © 2011 The Authors. EMA © 2011 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  16. 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

  17. [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.

  18. Prevalence of metabolic syndrome at age 16 using the International Diabetes Federation paediatric definition.

    Science.gov (United States)

    Pirkola, J; Tammelin, T; Bloigu, A; Pouta, A; Laitinen, J; Ruokonen, A; Tapanainen, P; Järvelin, M-R; Vääräsmäki, M

    2008-11-01

    We estimated the prevalence of metabolic syndrome (MS) in adolescents, using the new International Diabetes Federation (IDF) paediatric definition and compared this with prevalence estimated using the IDF adult definition and five other previously published definitions. Cross-sectional survey in the prospective general population-based Northern Finland Birth Cohort 1986 (NFBC 1986) at age 16 years. Birth cohort in Finland. 5665 adolescents (2862 males and 2803 females) clinically examined in 2001-2002. The prevalence of MS using different definitions. The overall prevalence of MS using the IDF paediatric definition was 2.4% (95% CI 2.0 to 2.8%) at the age of 16 years. Using the IDF adult definition the overall prevalence was lower, 1.7% (CI 1.3 to 2.0%, European cut-offs for waist circumference) and 1.0% (CI 0.7 to 1.3%, North American cut-offs). In 16-year-old adolescents, the paediatric IDF definition rendered a higher prevalence estimate than the adult definition.

  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. 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)

  1. 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

  2. International Federation of Library Associations General Conference, Montreal 1982. Official Opening Statements and Speeches. Plenary Session I and II. Papers.

    Science.gov (United States)

    International Federation of Library Associations, The Hague (Netherlands).

    Official opening statements and papers on networking and the development of information technology which were presented at the 1982 International Federation of Library Associations (IFLA) conference include: (1) opening speeches by Else Granheim (IFLA president) and Kenneth H. Rogers (UNESCO Representative); (2) "The Importance of Networks…

  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. Probable blind spot in the International Diabetes Federation definition of metabolic syndrome.

    Science.gov (United States)

    Chen, Hsin-Jen; Pan, Wen-Harn

    2007-05-01

    The International Diabetes Federation (IDF) proposed a novel definition of the metabolic syndrome (MS) in 2005, which designated central obesity as mandatory. The new National Cholesterol Education Program (NCEP) version, announced by the American Heart Association and National Heart Lung and Blood Institute in October 2005, did not favor any of the five components. We set out to compare the cardiovascular profiles of patients cross-defined by these two definitions to shed light on the differential meanings of the two. We analyzed data from 2608 non-institutionalized adults (> or =19 years old) in the National Nutrition and Health Survey in Taiwan, who had complete data for the five MS defining components. Both definitions adopted lower cut-points for fasting glucose and race-specific cut-points for waist circumference. Under the IDF's and new NCEP's definitions, the MS prevalence was 6.2% and 11.6% in men and 12.6% and 16.5% in women, respectively. Although the two definitions had high agreement, IDF failed to pick up approximately 4% to 5% of people with more than three MS component disorders but a waist circumference less than the cut-point. Subjects whose physical conditions only satisfied NCEP's definition had similar or worse metabolic profiles than those whose conditions satisfied both IDF's definition and the new NCEP's definition. The IDF definition would fail to identify a portion of people who have more than three MS component disorders but a small waistline. Further research and discussion are needed on whether and how to implement the IDF's definition.

  6. 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.

  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. Pengaruh Motivasi dan Disiplin Kerja Terhadap Kinerja Karyawan Pada PT Repex Perdana International (License of Federal Express) Medan

    OpenAIRE

    Rusandi, Adiguna Dwi

    2015-01-01

    The purpose of this research is to know and analyze the influence of motivation and work dicipline variables to employees performance of PT Repex Perdana International (License of Federal Express) Medan. This research is quantitative research using the survey method of Causal Associative which looks for the relation between one variable with another variable The population in this research were all courier as many 31 people. The sampling method using a sample that is saturated sampling techni...

  10. Pharmaceutical Research Strategies

    NARCIS (Netherlands)

    S.M.W. Phlippen (Sandra); A. 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

  11. A modified high-performance liquid chromatographic method for the analysis of pantoprazole sodium in pharmaceutical dosage forms using lansoprazole as internal standard

    Directory of Open Access Journals (Sweden)

    Safwan Ashour

    2016-09-01

    Full Text Available A Simple and rapid reversed-phase high-performance liquid chromatographic method for the direct determination of pantoprazole in pharmaceutical dosage forms was developed and validated. Lansoprazole was used as internal standard. The chromatographic separation of pantoprazole and lansoprazole was achieved on a Nucleodur C8 column (250 × 4.6 mm i.d., 5 μm particle size using the photodiode array detector at 280 nm. The optimized mobile phase was consisted of a mixture of 0.1 M ammonium acetate solution and methanol (42:58, v/v, pumped at a flow rate 1.0 mL min−1. The retention times for pantoprazole and lansoprazole were 8.10 and 11.15 min, respectively. Linearity range was 3.06–1243.0 μg mL−1 with limit of detection value of 0.78 μg mL−1. The precision of the method was demonstrated using intra- and inter-day assay RSD% values which were less than 2.07%, while the recovery was 99.07–103.95%. No interference from any components of pharmaceutical dosage forms or degradation products was observed. According to the validation results, the proposed method was found to be specific, accurate, precise and could be applied to the quantitative analysis of pantoprazole in tablets.

  12. 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.

  13. 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

  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. Experience of Internal and External Education Quality Rate: Esg and the Legislation of the Russian Federation

    Directory of Open Access Journals (Sweden)

    Nikanorov Ivan N.

    2017-01-01

    Full Text Available Overview of regulation of internal and external education quality rate has been presented. The development of regulation an independent assessment of higher education in Russia in the context of ESG has been considered. Authors noticed, that instruments of internal and external quality rate interact in Russian legislation insufficiently.

  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. 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.

  18. The pharmaceutical industry in Russia: reality and prospects

    OpenAIRE

    Gordeev, A.

    2009-01-01

    This section “Forum” is about the pharmaceutical industry in Russia. We were encouraged to debate this topic after the unveiling of the Strategy of Development of the Pharmaceutical Industry in the Russian Federation developed by the Ministry of Industry and Trade of the Russian Federation. The majority of our experts, who are authorities in the federal government, business, academia, and industrial science, believe that Russia needs a fully developed pharmaceutical industry. What are the mai...

  19. 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

  20. 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.

  1. 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

  2. 77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

    Science.gov (United States)

    2012-04-11

    ... sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations..., FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which...] International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic Benefit-Risk...

  3. 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.

  4. Prevalence of metabolic syndrome in urban and suburban Rivers State, Nigeria: International Diabetes Federation and Adult Treatment Panel III definitions.

    Science.gov (United States)

    Siminialayi, I M; Emem-Chioma, P C; Odia, O J

    2010-06-01

    It was not clear for a while, which of the definitions of metabolic syndrome best predicted those at risk of cardiovascular disease and diabetes but recent studies have confirmed the predictive ability of various definitions of metabolic syndrome and have reported that the International Diabetes Federation definition, although more sensitive is associated with a higher false positive predictive rate. To determine the prevalence of metabolic syndrome, using the International Diabetes Federation and Adult Treatment Panel III definitions among adult Nigerians attending Family Medicine Clinics at two hospitals in Rivers State Nigeria. Adult subjects attending family medicine clinics at an urban and a sub-urban hospital in Rivers State, Nigeria were bled after an overnight fast, and venous blood obtained for lipid studies and fasting plasma glucose estimations. Measurements were made to determine height, weight, waist circumference and blood pressure. The data obtained was analysed using SPSS for Windows software version 12 and Epi info version 6.04D RESULTS: The prevalence of metabolic syndrome was 19.81% (ATP III) and 23.19% (IDF) at one centre and 34.17% (ATP III) and 35.42% (IDF) at the other centre. The prevalence of metabolic syndrome by the two definitions was significantly higher at the second centre. The difference in the prevalence rates by the two definitions was also much smaller in the second centre perhaps because the second centre had more women and the mean age of the subjects was significantly higher.

  5. On International Cooperation and the Fluminense Federal Institute of Education, Science and Technology

    Directory of Open Access Journals (Sweden)

    Maria Inês Albernaz Kury

    2012-10-01

    Full Text Available This article aims to make a reflection about the need for internationalization of our institution and our own as well as an approach to the theme of International Cooperation and its meaning in the current scenario. This is a compilation of some documents and readings related to the themes in question.

  6. 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

  7. Elemental Impurities in Pharmaceutical Excipients.

    Science.gov (United States)

    Li, Gang; Schoneker, Dave; Ulman, Katherine L; Sturm, Jason J; Thackery, Lisa M; Kauffman, John F

    2015-12-01

    Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by a lack of publically available information on elemental impurity levels in common pharmaceutical excipients. This paper summarizes a recent survey of elemental impurity levels in common pharmaceutical excipients as well as some drug substances. A widely applicable analytical procedure was developed and was shown to be suitable for analysis of elements that are subject to United States Pharmacopoeia Chapter and International Conference on Harmonization's Q3D Guideline on Elemental Impurities. The procedure utilizes microwave-assisted digestion of pharmaceutical materials and inductively coupled plasma mass spectrometry for quantitative analysis of these elements. The procedure was applied to 190 samples from 31 different excipients and 15 samples from eight drug substances provided through the International Pharmaceutical Excipient Council of the Americas. The results of the survey indicate that, for the materials included in the study, relatively low levels of elemental impurities are present. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association.

  8. 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.

  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. 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

  11. 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.

  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. Injuries in men's international ice hockey: a 7-year study of the International Ice Hockey Federation Adult World Championship Tournaments and Olympic Winter Games.

    Science.gov (United States)

    Tuominen, Markku; Stuart, Michael J; Aubry, Mark; Kannus, Pekka; Parkkari, Jari

    2015-01-01

    Information on ice hockey injuries at the international level is very limited. The aim of the study was to analyse the incidence, type, mechanism and severity of ice hockey injuries in men's international ice hockey tournaments. All the injuries in men's International Ice Hockey Federation World Championship tournaments over a 7-year period were analysed using a strict definition of injury, standardised reporting strategies and an injury diagnosis made by a team physician. 528 injuries were recorded in games resulting in an injury rate of 14.2 per 1000 player-games (52.1/1000 player-game hours). Additionally, 27 injuries occurred during practice. For WC A-pool Tournaments and Olympic Winter Games (OWG) the injury rate was 16.3/1000 player-games (59.6/1000 player-game hours). Body checking, and stick and puck contact caused 60.7% of the injuries. The most common types of injuries were lacerations, sprains, contusions and fractures. A laceration was the most common facial injury and was typically caused by a stick. The knee was the most frequently injured part of the lower body and the shoulder was the most common site of an upper body injury. Arenas with flexible boards and glass reduced the risk of injury by 29% (IRR 0.71, (95% CI 0.56 to 0.91)). The incidence of injury during international ice hockey competition is relatively high. Arena characteristics, such as flexible boards and glass, appeared to reduce the risk of injury. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  14. The argument for pharmaceutical policy

    DEFF Research Database (Denmark)

    Traulsen, Janine Morgall; Almarsdóttir, Anna Birna

    2005-01-01

    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...

  15. 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

  16. 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.

  17. Integrating systematic screening for gender-based violence into sexual and reproductive health services: results of a baseline study by the International Planned Parenthood Federation, Western Hemisphere Region.

    Science.gov (United States)

    Guedes, A; Bott, S; Cuca, Y

    2002-09-01

    Three Latin American affiliates of the International Planned Parenthood Federation, Western Hemisphere Region, Inc. (IPPF/WHR) have begun to integrate gender-based violence screening and services into sexual and reproductive health programs. This paper presents results of a baseline study conducted in the affiliates. Although most staff support integration and many had already begun to address violence in their work, additional sensitization and training, as well as institution-wide changes are needed to provide services effectively and to address needs of women experiencing violence. Copyright 2002 International Federation of Gynecology and Obstetrics

  18. 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...

  19. Tropical Journal of Pharmaceutical Research: Submissions

    African Journals Online (AJOL)

    Type of Manuscripts. The Tropical Journal of Pharmaceutical Research is an international Open Access journal devoted to the promotion of pharmaceutical sciences and related disciplines (including biotechnology, cell and molecular biology, drug utilization including adverse drug events, medical and other life sciences, ...

  20. Evaluation of pharmaceutical assistance in public primary care in Brasília, Brazil Avaliação da assistência farmacêutica na atenção primária no Distrito Federal

    Directory of Open Access Journals (Sweden)

    Janeth de Oliveira Silva Naves

    2005-04-01

    Full Text Available OBJECTIVE: Pharmaceutical assistance is essential in health care and a right of citizens according to Brazilian law and drug policies. The study purpose was to evaluate aspects of pharmaceutical assistance in public primary health care. METHODS: A cross-sectional study using WHO drug indicators was carried out in Brasília in 2001. From a random sample of 15 out of 62 centers thirty exiting patients per center were interviewed. RESULTS: Only 18.7% of the patients fully understood the prescription, 56.3% could read it, 61.2% of the prescribed drugs were actually dispensed, and mean duration of pharmaceutical dispensing was 53.2 seconds. Each visit lasted on average 9.4 minutes. Of prescribed and non-dispensed drugs, 85.3% and 60.6% were on the local essential drug list (EDL respectively. On average 83.2% of 40 essential drugs were in stock, and only two centers had a pharmacist in charge of the pharmacy. The mean number of drugs per prescription was 2.3, 85.3% of prescribed drugs were on the EDL, 73.2% were prescribed using the generic denomination, 26.4% included antibiotics and 7.5% were injectables. The most prescribed groups were: cardiovascular drugs (26.8%, anti-infective drugs (13.1%, analgesics (8.9%, anti-asthmatic drugs (5.8%, anti-diabetic drugs (5.3%, psychoactive drugs (3.7%, and combination drugs (2.7%. CONCLUSIONS: Essential drugs were only moderately available almost 30 years after the first Brazilian EDL was formulated. While physician use of essential drugs and generic names was fairly high, efficiency was impaired by the poor quality of pharmaceutical care, resulting in very low patient understanding and insufficient guarantee of supply, particularly for chronic diseases.OBJETIVO: O acesso a medicamentos e seus serviços é indispensável às ações de saúde e um direito do cidadão segundo a política de medicamentos e a legislação brasileira. O objetivo do estudo foi avaliar aspectos da assistência farmacêutica na aten

  1. 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

  2. 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.

  3. 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.

  4. Prevalence of metabolic syndrome defined by the International Diabetes Federation and National Cholesterol Education Program criteria among Thai adults.

    Science.gov (United States)

    Aekplakorn, Wichai; Chongsuvivatwong, Virasakdi; Tatsanavivat, Pyatat; Suriyawongpaisal, Paibul

    2011-09-01

    This study determines the prevalence of metabolic syndrome (MetS) according to the International Diabetes Federation (IDF) and National Cholesterol Education Program III (NCEP) criteria in Thai adults. Data from a national representative sample, InterASIA study, including a total of 5305 Thai adults 35 years and older were analyzed. Overall, the age-standardized prevalence of MetS by IDF and NCEP criteria were 24.0% (men 16.4%, women 31.6%) and 32.6% (men 28.7%, women 36.4%), respectively. The difference in prevalence of MetS between genders was much greater for the IDF compared with the NCEP definition. The age-standardized prevalence rates distributed by geographic region were relatively uniform with a lowest prevalence in the northeast. Among all possible sets of components for MetS, the most common combinations were a set of low high-density lipoprotein cholesterol, high triglyceride, and hyperglycemia in men (3.9%) and a set of abdominal obesity, low high-density lipoprotein cholesterol, and high triglycerides in women (6.7%). MetS is common in Thai adults and NCEP definition captures more cases of MetS compared with the IDF definition. Implementation of programs to prevent obesity and metabolic factors along with future periodic survey to monitor the problem is crucial.

  5. 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

  6. 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

  7. 77 FR 67398 - Manufacturer of Controlled Substances; Notice of Application; INB Hauser Pharmaceutical Services...

    Science.gov (United States)

    2012-11-09

    ... Pharmaceutical Services, Inc. Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on September 20, 2012, InB Hauser Pharmaceutical Services, Inc., 6880 N. Broadway...

  8. 78 FR 12101 - Importer of Controlled Substances; Notice of Application; Caraco Pharmaceutical Laboratories, LTD.

    Science.gov (United States)

    2013-02-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Caraco Pharmaceutical... November 22, 2012, Caraco Pharmaceutical Laboratories, Ltd., 270 Prospect Plains Road, Cranbury, New Jersey...

  9. Pharmaceutical counterfeiting and the RFID technology intervention.

    Science.gov (United States)

    Coustasse, Alberto; Arvidson, Cody; Rutsohn, Phil

    2010-07-01

    Both nationally and internationally, pharmaceutical counterfeiting has become a problem that is threatening economic stability and public health. The purpose of the present research study review was to analyze the scope and severity of pharmaceutical counterfeiting and to establish if the implantation of the Radio Frequency Identification Device (RFID) model can more efficiently be used within the pharmaceutical supply chain to reduce the problem counterfeit drugs impose on public health and international economic stability. Results indicated that implementing the RFID model for tracking drugs at the item level in the pharmaceutical supply chain has potential to alleviate the scope of the counterfeit drug problem. Recommendations for how the pharmaceutical industry may sooner adopt the RFID model are made.

  10. Preparticipation predictors for championship injury and illness: cohort study at the Beijing 2015 International Association of Athletics Federations World Championships.

    Science.gov (United States)

    Timpka, Toomas; Jacobsson, Jenny; Bargoria, Victor; Périard, Julien D; Racinais, Sébastien; Ronsen, Ola; Halje, Karin; Andersson, Christer; Dahlström, Örjan; Spreco, Armin; Edouard, Pascal; Alonso, Juan-Manuel

    2017-02-01

    To determine preparticipation predictors of injury and illness at a major Athletics championship. A cohort study design was used. Before the 2015 International Association of Athletics Federations World Championships in Athletics, all 207 registered national teams were approached about partaking in a study of preparticipation health; 50 teams accepted. The athletes (n=957) in the participating teams were invited to complete a preparticipation health questionnaire (PHQ). New injuries and illnesses that occurred at the championships were prospectively recorded. Logistic regression analyses were performed with simple and multiple models using any in-championship injury and in-championship illness as outcomes. The PHQ was completed by 307 (32.1%) of the invited athletes; 116 athletes (38.3%) reported an injury symptom during the month before the championships, while 40 athletes (13%) reported an illness symptom. 20 (6.5%) of the participating athletes sustained a health problem during the championships. Endurance athletes were almost 10-fold more likely to sustain an in-championship illness than speed/power athletes (OR, 9.88; 95% CI 1.20 to 81.31; p=0.033). Participants reporting a preparticipation gradual-onset injury symptom were three times more likely (OR, 3.09; 95% CI 1.08 to 8.79; p=0.035) and those reporting an illness symptom causing anxiety were fivefold more likely (OR, 5.56; 95% CI 1.34 to 23.15; p=0.018) to sustain an in-championship injury. Analyses of preparticipation predictors of injury and illness at a major Athletics championship suggest that endurance athletes require particular clinical attention. Preparticipation symptoms causing anxiety are interesting predictors for in-championship health problems. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  11. Prevalence of metabolic syndrome according to Adult Treatment Panel III and International Diabetes Federation criteria: a population-based study.

    Science.gov (United States)

    Bener, Abdulbari; Zirie, Mahmoud; Musallam, Manal; Khader, Yousef S; Al-Hamaq, Abdulla O A A

    2009-06-01

    The objective of the study was to examine the prevalence of metabolic syndrome among adult Qatari population according to the revised criteria of the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) and the International Diabetes Federation (IDF), assess which component contributed to the increased risk of the metabolic syndrome, and identify the characteristics of the subjects with metabolic syndrome. This was a cross-sectional study. The survey was carried out in urban and semiurban primary health-care centers. The survey was conducted from January, 2007, to July, 2008, among Qatari nationals above 20 years of age. Of the 1496 subjects who were approached to participate in the study, 1204 (80.5%) gave their consent. Face-to-face interviews were conducted using a structured questionnaire followed by laboratory tests. Metabolic syndrome was defined using the NCEP ATP III as well as IDF criteria. The overall prevalence of metabolic syndrome in studied subjects was 26.5% and 33.7% according to ATP III and IDF criteria (P education and physical activity. Also, the prevalence of metabolic syndrome was more common in women. Among the components of metabolic syndrome, central obesity was significantly higher in the studied subjects. The IDF definition of metabolic syndrome gave a higher prevalence in all age groups. The overall prevalence of metabolic syndrome and its components according to IDF criteria was higher in the studied subjects than the estimates given by the ATP III. Multivariate logistics regression analysis (ATP III and IDF) showed that age and BMI were significant contributors for metabolic syndrome. Both definitions strongly supported age and obesity as associated factors for metabolic syndrome. The current study found a high prevalence of metabolic syndrome among Qataris. There was a steady increase in the prevalence of metabolic syndrome through the decades, independent of the definition. Age and BMI were important

  12. 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

  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 [fr

  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. 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.

  16. 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

  17. Agreements concluded by the Federal Republic of Germany under international law in the field of environmental protection. Source index in the Federal Law Gazette, part II. As of June 1, 1992

    International Nuclear Information System (INIS)

    Lohse, S.

    1992-01-01

    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 is made 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.) [de

  18. 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

  19. [Assessment of the pharmaceutical expenditure in Hungary].

    Science.gov (United States)

    Inotai, András; Merész, Gergo; Kaló, Zoltán

    2010-01-01

    Scarcity of health care resources draws attention to the expenditure on pharmaceuticals, as drugs are considered to be one of the major growth drivers of health care spending. This article assesses the Hungarian expenditure on pharmaceuticals by taking into account the economic status of the country and benchmarks from other OECD countries with special focus on indicators of Visegrad V4 countries (Czech Republic, Slovakia, Poland and Hungary). Our results highlight the heterogeneity of pharmaceutical expenditure data derived from different indicators among observed countries. Pharmaceutical spending is relatively higher in middle-income countries, mainly due the price convergence of innovative drug's, on contrary manpower cost of health care services are adjusted to local price levels, therefore the price differential of health care services between middle income and developed countries is greater. International trends of the global pharmaceutical market are also valid in Hungary. Increased private funding, mainly out of pocket payments above the average of V4 countries, has been the major growth driver of pharmaceutical expenditure recently in Hungary. Increased private pharmaceutical expenditure was mainly derived from the severe cost-containment measures in 2006. The annual growth rate of the National Health Insurance Fund's pharmaceutical budget for drug reimbursement was 1.37% in real terms between 1994 and 2009. This is much beneath the expansion of global pharmaceutical market. Consequently, cost-containment of public pharmaceutical spending was very successful in the last fifteen years, and the burden of market growth has been shifted to households. Public health programmes, investment into preventive care, with consideration on unfavourable Hungarian morbidity and mortality indicators, however, necessitate the increase of public pharmaceutical budget. In order to improve the allocative efficiency of health care spending, available resources should be spent

  20. Original Research Article Pharmaceutical Care Implementation

    African Journals Online (AJOL)

    Erah

    Federation (FIP) defined pharmaceutical care. (PC) as “the responsible provision of pharmacotherapy for the ... products” [1] This definition was a slight modification of that of Helpler and Strand. (1990) which is the most ... hypertensive patients in a Nigerian community pharmacy where a significant difference between.

  1. 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

  2. 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

  3. 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

  4. 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.

  5. International Student Access to U.S. Higher Education since World War II: How NAFSA (Association of International Educators) Has Influenced Federal Policy

    Science.gov (United States)

    Miyokawa, Norifumi

    2009-01-01

    This dissertation is a study of the policy process behind the legislation and regulation governing international student access to U.S. higher education since the immediate aftermath of World War II. The particular research focus of this dissertation is on NAFSA: Association of International Educators (originally established as the National…

  6. 78 FR 12104 - Manufacturer of Controlled Substances; Notice of Registration; INB Hauser Pharmaceutical Services...

    Science.gov (United States)

    2013-02-21

    ... 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., 6880 N. Broadway, Suite H, Denver... considered the factors in 21 U.S.C. 823(a), and determined that the registration of InB Hauser Pharmaceutical...

  7. 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.

  8. 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.

  9. 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

  10. 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)

  11. 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

  12. 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...

  13. [Healthy pharmaceutical policy].

    Science.gov (United States)

    González Pier, Eduardo

    2008-01-01

    Today, the pharmaceutical industry is experiencing a profound transition. Globalization and technological advancement represent the principal pressures for change in the market, where it is increasingly more difficult for this type of industry to efficiently recoup the growing cost of innovation. Mexico needs to analyze the policy implications of these change factors and promote, in the pharmaceutical market, policies that maximize health gains on invested resources. Pharmaceutical policy offers a rare example for a complementary approach between a sound health policy and an efficient economic policy; that is, a "healthy pharmaceutical policy."

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  15. New £30M funding for british part of international computer grid Powerful international federation of computers moves into the next phase.

    CERN Multimedia

    Reeves, Danielle

    2007-01-01

    "The British arm of an international effort to build a computing Grid powerful enough to analyse data from the Large Hadron Collider (LHC) particle accelerator at CERN has been awarded GBP 30 million new funding, it was announced last week." (1 page)

  16. Pharmaceutical policies in a crisis? : Challenges and solutions identified at the PPRI Conference

    NARCIS (Netherlands)

    Vogler, Sabine; Zimmermann, Nina; Ferrario, Alessandra; Wirtz, Veronika J; de Joncheere, Kees; Pedersen, Hanne Bak; Dedet, Guillaume; Paris, Valérie; Mantel-Teeuwisse, Aukje K|info:eu-repo/dai/nl/266775098; Babar, Zaheer-Ud-Din

    2016-01-01

    In October 2015, the third international Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference was held in Vienna to foster discussion on challenges in pricing and reimbursement policies for medicines. The research presented highlighted that commonly used pharmaceutical pricing and

  17. 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.

  18. Ethiopian Pharmaceutical Journal: Submissions

    African Journals Online (AJOL)

    Author Guidelines. Aim. Ethiopian Pharmaceutical Journal (EPJ) is a bian-nual Journal, which publishes original research works, that contribute significantly to further scientific knowledge in Pharmaceutical Sciences. The Journal publishes original research work either as a Full Re-search Paper or as a Short ...

  19. 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

  20. 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.

  1. 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…

  2. 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...

  3. 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

  4. 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.

  5. Metabolic syndrome in children: comparison of the International Diabetes Federation 2007 consensus with an adapted National Cholesterol Education Program definition in 300 overweight and obese French children.

    Science.gov (United States)

    Druet, Céline; Ong, Ken; Levy Marchal, Claire

    2010-01-01

    Former definitions of metabolic syndrome (MS) in children have been adapted from adult MS definitions using age-related thresholds for each biochemical component, whereas the International Diabetes Federation (IDF) definition is based on absolute values. We compared the IDF childhood MS definition (IDF-MS) to the adapted National Cholesterol Education Program (adapted-NCEP) definition in overweight children. 300 overweight and obese children were included with a median age of 11 years and BMI SDS of +4.7. Below 10 years of age, the frequency of MS according to the adapted-NCEP-MS definition was 18.6%, and 86.1% had abdominal obesity. In children aged 10 to definition and appears to identify a group of children with higher fasting insulin than the adapted-MS definition which uses age-related thresholds (90th percentile). Copyright 2010 S. Karger AG, Basel.

  6. Criteria for intraventricular conduction disturbances and pre-excitation. World Health Organizational/International Society and Federation for Cardiology Task Force Ad Hoc.

    Science.gov (United States)

    Willems, J L; Robles de Medina, E O; Bernard, R; Coumel, P; Fisch, C; Krikler, D; Mazur, N A; Meijler, F L; Mogensen, L; Moret, P

    1985-06-01

    In an effort to standardize terminology and criteria for clinical electrocardiography, and as a follow-up of its work on definitions of terms related to cardiac rhythm, an Ad Hoc Working Group established by the World Health Organization and the International Society and Federation of Cardiology reviewed criteria for the diagnosis of conduction disturbances and pre-excitation. Recommendations resulting from these discussions are summarized for the diagnosis of complete and incomplete right and left bundle branch block, left anterior and left posterior fascicular block, nonspecific intraventricular block, Wolff-Parkinson-White syndrome and related pre-excitation patterns. Criteria for intraatrial conduction disturbances are also briefly reviewed. The criteria are described in clinical terms. A concise description of the criteria using formal Boolean logic is given in the Appendix. For the incorporation into computer electrocardiographic analysis programs, the limits of some interval measurements may need to be adjusted.

  7. Ecotoxicology of human pharmaceuticals.

    Science.gov (United States)

    Fent, Karl; Weston, Anna A; Caminada, Daniel

    2006-02-10

    Low levels of human medicines (pharmaceuticals) have been detected in many countries in sewage treatment plant (STP) effluents, surface waters, seawaters, groundwater and some drinking waters. For some pharmaceuticals effects on aquatic organisms have been investigated in acute toxicity assays. The chronic toxicity and potential subtle effects are only marginally known, however. Here, we critically review the current knowledge about human pharmaceuticals in the environment and address several key questions. What kind of pharmaceuticals and what concentrations occur in the aquatic environment? What is the fate in surface water and in STP? What are the modes of action of these compounds in humans and are there similar targets in lower animals? What acute and chronic ecotoxicological effects may be elicited by pharmaceuticals and by mixtures? What are the effect concentrations and how do they relate to environmental levels? Our review shows that only very little is known about long-term effects of pharmaceuticals to aquatic organisms, in particular with respect to biological targets. For most human medicines analyzed, acute effects to aquatic organisms are unlikely, except for spills. For investigated pharmaceuticals chronic lowest observed effect concentrations (LOEC) in standard laboratory organisms are about two orders of magnitude higher than maximal concentrations in STP effluents. For diclofenac, the LOEC for fish toxicity was in the range of wastewater concentrations, whereas the LOEC of propranolol and fluoxetine for zooplankton and benthic organisms were near to maximal measured STP effluent concentrations. In surface water, concentrations are lower and so are the environmental risks. However, targeted ecotoxicological studies are lacking almost entirely and such investigations are needed focusing on subtle environmental effects. This will allow better and comprehensive risk assessments of pharmaceuticals in the future.

  8. Tropical Journal of Pharmaceutical Research

    African Journals Online (AJOL)

    An Overview of Pharmaceutical Validation and Process Controls in Drug Development. ... Thus validation is an integral part of quality assurance. This overview examines the need for pharmaceutical validation and the various ... pharmaceutical process control. Tropical Journal of Pharmaceutical Research 2002; 1(2): 115 ...

  9. 77 FR 29665 - International Conference on Harmonisation; Addendum to International Conference on Harmonisation...

    Science.gov (United States)

    2012-05-18

    ... Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug... products derived from cell-culture systems such as bacteria, yeast, and eukaryotic cells, including...

  10. 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

  11. [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

  12. 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

  13. 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...

  14. 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.

  15. 75 FR 54232 - Proposed Collection; Comment Request for Report of Covered Pharmaceutical Manufacturers and...

    Science.gov (United States)

    2010-09-03

    ... Request for Report of Covered Pharmaceutical Manufacturers and Importers (Form-8947) AGENCY: Internal... Pharmaceutical Manufacturers and Importers. DATES: Written comments should be received on or before November 2... INFORMATION: Title: Report of Covered Pharmaceutical Manufacturers and Importers. OMB Number: 1545-XXXX. Form...

  16. Fiscal Federalism

    Directory of Open Access Journals (Sweden)

    Tatiana Mosteanu

    2007-06-01

    Full Text Available The central budget of a country collects only a fraction of the total fiscal revenues and executes only o fraction of the national public expenditures, the rest of the revenues and expenditures becoming the responsability of subnational governments. The economist Charles Tiebout developed a theoretical model which although makes an imperfect description of the reality, shows that people’s mobility is being influenced by tax rates and the amount of state/local expenditures. Thus, he suggests that the degree of responsibility that can be appointed to the local budgets should subscribe to the tax – benefits ratio, the extend of the positive externalities and the scale economies of public goods. Also, the issue of revenues distribution among communities is being raised, being identified three kinds of grants used by the public authorities: matching grants, block grants and conditional block grants. In the concept of fiscal federalism there can be found a limited analogy between national public finance theory and international public finance theory, with the international taxation as the pivotal element.

  17. 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.

  18. Pharmaceuticals Exposed to the Space Environment: Problems and Prospects

    Science.gov (United States)

    Jaworske, Donald A.; Myers, Jerry G.

    2016-01-01

    The NASA Human Research Program (HRP) Health Countermeasures Element maintains ongoing efforts to inform detailed risks, gaps, and further questions associated with the use of pharmaceuticals in space. Most recently, the Pharmacology Risk Report, released in 2010, illustrates the problems associated with maintaining pharmaceutical efficacy. Since the report, one key publication includes evaluation of pharmaceutical products stored on the International Space Station (ISS). This study shows that selected pharmaceuticals on ISS have a shorter shelf-life in space than corresponding terrestrial controls. The HRP Human Research Roadmap for planetary exploration identifies the risk of ineffective or toxic medications due to long-term storage during missions to Mars. The roadmap also identifies the need to understand and predict how pharmaceuticals will behave when exposed to radiation for long durations. Terrestrial studies of returned samples offer a start for predictive modeling. This paper shows that pharmaceuticals returned to Earth for post-flight analyses are amenable to a Weibull distribution analysis in order to support probabilistic risk assessment modeling. The paper also considers the prospect of passive payloads of key pharmaceuticals on sample return missions outside of Earth's magnetic field to gather additional statistics. Ongoing work in radiation chemistry suggests possible mitigation strategies where future work could be done at cryogenic temperatures to explore methods for preserving the strength of pharmaceuticals in the space radiation environment, perhaps one day leading to an architecture where pharmaceuticals are cached on the Martian surface and preserved cryogenically.

  19. 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....

  20. 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.

  1. 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.

  2. Geographic variations of the International Diabetes Federation and the National Cholesterol Education Program-Adult Treatment Panel III definitions of the metabolic syndrome in nondiabetic subjects.

    Science.gov (United States)

    Lorenzo, Carlos; Serrano-Ríos, Manuel; Martínez-Larrad, María T; González-Sánchez, José L; Seclén, Segundo; Villena, Arturo; Gonzalez-Villalpando, Clicerio; Williams, Ken; Haffner, Steven M

    2006-03-01

    We have carried out international comparisons of the metabolic syndrome using the International Diabetes Federation (IDF) and National Cholesterol Education Program-Adult Treatment Panel III (ATP III) definitions. This analysis could help to discern the applicability of these definitions across populations. Nondiabetic subjects aged 35-64 years were eligible for analysis in population-based studies from San Antonio (Mexican Americans and non-Hispanic whites, n = 2,473), Mexico City (n = 1,990), Spain (n = 2,540), and Peru (n = 346). Kappa statistics examined the agreement between metabolic syndrome definitions. Because of the lower cutoff points for elevated waist circumference, the IDF definition of the metabolic syndrome generated greater prevalence estimates than the ATP III definition. Prevalence difference between definitions was more significant in Mexican-origin and Peruvian men than in Europid men from San Antonio and Spain because the IDF definition required ethnic group-specific cutoff points for elevated waist circumference. ATP III and IDF definitions disagreed in the classification of 13-29% of men and 3-7% of women. In men, agreement between these definitions was 0.54 in Peru, 0.43 in Mexico City, 0.62 in San Antonio Mexican Americans, 0.69 in San Antonio non-Hispanic whites, and 0.64 in Spain. In women, agreement between definitions was 0.87, 0.89, 0.86, 0.87, and 0.93, respectively. The IDF definition of the metabolic syndrome generates greater prevalence estimates than the ATP III definition. Agreement between ATP III and IDF definitions was lower for men than for women in all populations and was relatively poor in men from Mexico City.

  3. Prevalence of the metabolic syndrome among Korean adults using the new International Diabetes Federation definition and the new abdominal obesity criteria for the Korean people.

    Science.gov (United States)

    Kim, Hee Man; Kim, Dae Jung; Jung, In Hyun; Park, Chanwang; Park, Jong

    2007-07-01

    This study was performed to compare the prevalence of the metabolic syndrome according to the International Diabetes Federation (IDF) and National Cholesterol Education Program (NCEP) definitions, and abdominal obesity criteria of WHO and the Korean Society for the Study of Obesity (KSSO) in Korean adults. A total of 4452 adults aged > or =20 years from the Korean National Health and Nutrition Examination Survey 2001 were analyzed. The prevalence of the metabolic syndrome estimated by NCEP definition with WHO criteria, NCEP with KSSO, IDF with WHO, and IDF with KSSO were 26.7%, 23.7%, 23.8% and 17.5%, respectively. The agreement percent among the four definitions ranged from 88.7% to 100% in men, and from 85.6% to 94.9% in women. The NCEP-defined metabolic syndrome was more strongly associated with hypertension and diabetes than the IDF-defined metabolic syndrome (age-adjusted odds ratio: 5.1 versus 3.6 for hypertension and 6.4 versus 3.2 for diabetes in men, respectively; 5.4 versus 3.4-4.3 for hypertension and 11.1 versus 3.8-4.2 for diabetes in women, respectively). Both definitions of the metabolic syndrome were associated with coronary heart disease or stroke only in women. Prospective studies are warranted to evaluate the predictive ability of the new definition of the metabolic syndrome and the new criteria of abdominal obesity for cardiovascular morbidity and mortality in Korean adults.

  4. High prevalence of abdominal obesity increases the risk of the metabolic syndrome in Nigerian type 2 diabetes patients: using the International Diabetes Federation worldwide definition.

    Science.gov (United States)

    Ezenwaka, Chidum E; Okoye, Osita; Esonwune, Chibuike; Onuoha, Philip; Dioka, Chudi; Osuji, Charles; Oguejiofor, Celestine; Meludu, Samuel

    2014-06-01

    Some Nigerian studies have reported cases of the metabolic syndrome in the population. This study aims to assess the prevalence of the components of the metabolic syndrome in type 2 diabetes mellitus (T2DM) patients using the International Diabetes Federation (IDF) worldwide definition. Eighty-nine T2DM patients were studied after an overnight fast. The patients' blood pressure, anthropometric indices, and biochemical parameters were measured. The components of the metabolic syndrome-raised blood pressure, waist circumference, triglycerides (TGs), and reduced high-density lipoprotein cholesterol (HDL-C)-were calculated using the IDF definition for the European ethnic group. About 25% of the patients had raised blood pressure (>130/85 mmHg), with the male patients having higher prevalence of raised systolic blood pressure (SBP>130 mmHg) than the female patients (73.3 vs. 52.3%, P0.05), abdominal obesity predominates significantly in female patients (97.7 vs. 68.9%, Prisk of cardiovascular disease (CVD). We recommend that diabetes education emphasizing the risk of CVD in patients with increased abdominal fat should be intensified in the developing countries.

  5. 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 t...

  6. 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...

  7. Horizon Scanning for Pharmaceuticals

    DEFF Research Database (Denmark)

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

    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...

  8. 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 is ...

  9. Doctors and pharmaceutical industry.

    Science.gov (United States)

    Beran, Roy G

    2009-09-01

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

  10. Photoinduced chemiluminescence of pharmaceuticals.

    Science.gov (United States)

    Gómez-Taylor, B; Palomeque, M; García Mateo, J V; Martínez Calatayud, J

    2006-05-03

    A screening test for the forward development of chemiluminescence systems able to determine pharmaceutical compounds is reported. The test is based on the on-line photodegradation of the drugs by using a photoreactor consisting of 697 cmx0.5 mm PTFE tubing helically coiled around an 8 W low-pressure mercury lamp. Photodegraded pharmaceuticals are detected by direct chemiluminescence of the resulting photofragments and their subsequent reaction with potassium permanganate in sulphuric acid medium as oxidant. The screening comprised 97 compounds with different molecular structures and relevant members of the most important families of pharmaceuticals are tested (amino acids, carboxylic acids, nitrocompounds, phenyl-alkyl and aromatic amines, sulphonic acid amides, polycarbocyclics, monocyclic N-containing heterocyclics, bicyclic N-containing heterocyclics, tricyclic N-containing heterocyclics, N-S containing heterocyclics...). Due to the relevant influence of the medium for the photodegradation a wide range of pH's and buffer solutions were studied. The proposed strategy (photoinduced chemiluminescence, Ph-CL) allows the development of systems for the determination of many pharmaceuticals which do not present "native" chemiluminescence (e.g. chloramphenicol, dextromethorpham, riboflavin, ephedrine, piperazinamide, chlotrimazole, theophylline...). Moreover, Ph-CL allows to increase the sensitivity of chemiluminescence procedures based on direct chemiluminescence detection (e.g. sulphonamides, thiazides, nicontinamide, nortryptiline, levamisole, phenylbarbituric acid...).

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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...

  16. 77 FR 47114 - Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical Inc.

    Science.gov (United States)

    2012-08-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical... that on July 6, 2012, Halo Pharmaceutical Inc., 30 North Jefferson Road, Whippany, New Jersey 07981...

  17. 77 FR 75223 - Spencer Pharmaceutical Inc.; Order of Suspension of Trading

    Science.gov (United States)

    2012-12-19

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Spencer Pharmaceutical Inc.; Order of Suspension of Trading December 17, 2012. It appears to the... securities of Spencer Pharmaceutical Inc. (``Spencer'') because of questions regarding the accuracy of...

  18. 78 FR 29200 - Benda Pharmaceutical, Inc. and China Shuangjii Cement Ltd., Order of Suspension of Trading

    Science.gov (United States)

    2013-05-17

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Benda Pharmaceutical, Inc. and China Shuangjii Cement Ltd., Order of Suspension of Trading May 15... information concerning the securities of Benda Pharmaceutical, Inc. because it has not filed any periodic...

  19. 78 FR 51210 - Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical, Inc.

    Science.gov (United States)

    2013-08-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Halo Pharmaceutical... that on July 8, 2013, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey 07981...

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

    Science.gov (United States)

    2012-03-20

    ... has investigated Johnson Matthey, Inc. to ensure that the company's registration is consistent with... 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 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... (9740) II The company plans to utilize this facility to manufacture small quantities of the listed...

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. Comparison of type 2 diabetes prevalence estimates in Saudi Arabia from a validated Markov model against the International Diabetes Federation and other modelling studies

    Science.gov (United States)

    Al-Quwaidhi, Abdulkareem J.; Pearce, Mark S.; Sobngwi, Eugene; Critchley, Julia A.; O’Flaherty, Martin

    2014-01-01

    Aims To compare the estimates and projections of type 2 diabetes mellitus (T2DM) prevalence in Saudi Arabia from a validated Markov model against other modelling estimates, such as those produced by the International Diabetes Federation (IDF) Diabetes Atlas and the Global Burden of Disease (GBD) project. Methods A discrete-state Markov model was developed and validated that integrates data on population, obesity and smoking prevalence trends in adult Saudis aged ≥25 years to estimate the trends in T2DM prevalence (annually from 1992 to 2022). The model was validated by comparing the age- and sex-specific prevalence estimates against a national survey conducted in 2005. Results Prevalence estimates from this new Markov model were consistent with the 2005 national survey and very similar to the GBD study estimates. Prevalence in men and women in 2000 was estimated by the GBD model respectively at 17.5% and 17.7%, compared to 17.7% and 16.4% in this study. The IDF estimates of the total diabetes prevalence were considerably lower at 16.7% in 2011 and 20.8% in 2030, compared with 29.2% in 2011 and 44.1% in 2022 in this study. Conclusion In contrast to other modelling studies, both the Saudi IMPACT Diabetes Forecast Model and the GBD model directly incorporated the trends in obesity prevalence and/or body mass index (BMI) to inform T2DM prevalence estimates. It appears that such a direct incorporation of obesity trends in modelling studies results in higher estimates of the future prevalence of T2DM, at least in countries where obesity has been rapidly increasing. PMID:24447810

  7. Differences in traditional and emerging cardiovascular risk factors of subjects discordantly classified by metabolic syndrome definitions of the International Diabetes Federation and the National Cholesterol Education Program.

    Science.gov (United States)

    Boronat, M; Saavedra, P; Varillas, V F; Wagner, A M; López-Plasencia, Y; Alberiche, M P; Nóvoa, F J

    2009-07-01

    Several working definitions of metabolic syndrome have been proposed for clinical use. However, individuals can be discordantly classified as having or not having metabolic syndrome depending on the choice of one or another definition. This study compared the cardiovascular risk profile of subjects concordantly and discordantly diagnosed by the criteria of the National Cholesterol Education Program (NCEP) and the criteria of the International Diabetes Federation (IDF). Nine hundred and twenty-nine non-diabetic adult subjects belonging to a cross-sectional population-based study in Gran Canaria island (Spain) were assessed. Participants completed a questionnaire and underwent physical examination, fasting blood analyses, and a standardized oral glucose tolerance test. Two hundred and four subjects (22%) had metabolic syndrome according to both definitions, 31 (3.3%) only by the IDF criteria, and 5 (0.5%) only by the NCEP criteria. Participants fulfilling both proposals showed more adverse age and sex-adjusted measures of BMI, waist, HDL cholesterol, triglycerides, post-load glucose, HOMA-IR and plasminogen inhibitor activator-1 (PAI-1) than individuals exclusively satisfying the IDF criteria. Moreover, in contrast to subjects meeting both criteria, those that fulfilled only the IDF criteria had levels of BMI, waist, total and HDL cholesterol, post-load glucose, glycated HbA1c, C-reactive protein, PAI-1 and fibrinogen not significantly different from those observed in subjects without metabolic syndrome. The IDF definition identifies a surplus of individuals whose cardiovascular risk profile, particularly regarding to some non-traditional cardiovascular risk factors, is less adverse than that observed in subjects also diagnosed by the NCEP definition.

  8. Prevalence of metabolic syndrome in urban Pakistan (Karachi): comparison of newly proposed International Diabetes Federation and modified Adult Treatment Panel III criteria.

    Science.gov (United States)

    Hydrie, M Zafar Iqbal; Shera, A Samad; Fawwad, Asher; Basit, Abdul; Hussain, Akhtar

    2009-04-01

    The clustering of central obesity, dyslipidemia, hypertension, and hyperglycemia known as metabolic syndrome has been associated with a two- to three-fold increase in type 2 diabetes (T2DM) and cardiovascular disease (CVD). It is recognized that the features of the metabolic syndrome can be present 10 years preceding T2DM and CVD. The objective of our study was to determine the prevalence of metabolic syndrome in adults aged 25 years and older from an urban population of Karachi, Pakistan, according to the International Diabetes Federation (IDF) definition and modified Adult Treatment Panel III (ATP III) criteria. This study involved a survey conducted from July, 2004, to December, 2004, by generating a computerized random sample of households in Lyari Town using a geographical imaging system (GIS). Out of the 85,520 households, 532 households were randomly selected and 867 adults > or =25 years old consented to take part in the survey; 363 of these subjects gave blood samples. The prevalence of diabetes was 9.4%, whereas 5.6% had impaired fasting glucose (abnormal glucose tolerance 15%). The prevalence of metabolic syndrome according to the IDF definition and modified ATP III criteria was 34.8% and 49%, respectively. Inclusion of modified waist circumference and specific body mass index (BMI) cut offs for Asians may help predict metabolic syndrome at an early stage. High prevalence of metabolic syndrome was identified irrespective of the definition applied in this population. This may call for immediate action to halt the accelerating risk of diabetes and CVD that would lead to a possible unparalleled rise in the cost of health care and human suffering.

  9. National Cholesterol Education Program and International Diabetes Federation definitions of metabolic syndrome in the prediction of diabetes. Results from the FIrenze-Bagno A Ripoli study.

    Science.gov (United States)

    Mannucci, E; Monami, M; Cresci, B; Pala, L; Bardini, G; Petracca, M G; Dicembrini, I; Pasqua, A; Buiatti, E; Rotella, C M

    2008-05-01

    The International Diabetes Federation (IDF) proposed to modify the diagnostic criteria for metabolic syndrome (MS) previously issued by the National Cholesterol Education Program (NCEP). Aim of the present investigation is to compare the predictive value for diabetes of NCEP and IDF definitions of MS in a large sample of predominantly Caucasian subjects. A prospective observational study was performed on a cohort study (n = 3096) enrolled in a diabetes-screening programme, the FIrenze-Bagno A Ripoli study. All subjects with fasting glucose >126 mg/dl and/or post-load glucose > or =200 mg/dl (5.7%) were excluded from the present analysis. Follow-up of each subject was continued until diagnosis of diabetes, death or until 31 December 2005. Mean follow-up was 27.7 +/- 11.3 months. Among subjects enrolled, 13.7 and 25.2% were affected by MS using NCEP and IDF criteria respectively. During follow-up, 38 new cases of diabetes were diagnosed, with a yearly incidence rate of 0.5%. The relative risk for diabetes in subjects with MS was 10.10 [5.13; 20.00] and 7.87 [3.70; 16.7] using NCEP and IDF definitions respectively. After adjustment for age, sex, fasting glucose and waist circumference, NCEP-defined MS, but not IDF-, was significantly associated with incident diabetes (hazard ratio, 95% CI: 2.41 [1.01; 5.95] and 2.05 [0.80; 5.29] respectively). Although the reasons for the proposed changes in diagnostic criteria for MS are easily understandable, the newer IDF definition, while increasing estimates of prevalence of the syndrome, reduces the effectiveness of MS in identifying subjects at risk for diabetes. Further research is needed before the previous NCEP criteria are abandoned.

  10. 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.

  11. 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.

  12. [Concordance between three definitions for metabolic syndrome (Hypertriglyceridemic waist, National Cholesterol Education Program, International Diabetes Federation), and prevalence of the syndrome in a French population].

    Science.gov (United States)

    Nawabzad, Raphaël; Champin, Bernard

    2010-12-20

    The metabolic syndrome is associated with an increased risk of diabetes and cardiovascular disease. However, only the Hypertriglyceridemic waist (HTGW) criterions have been chosen for their ability to identify a group of patients with a higher cardiovascular risk independently of the traditional risk factors. The aim of this study was to examinate the real concordance of the metabolic syndrome according to the HTGW definition, National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) definition and the International Diabetes Federation (IDF) definition. We also evaluated the prevalence of the metabolic syndrome in a French population. The study was conducted on a sample of 232 patients, of both sexes, aged from 30 to 65 years old, recruited in general practice. Patients had a medical examination, and biological analyses were performed to assess their metabolic status. Kappa concordance coefficient was 0.46 between HTGW and NCEP ATP III; it was 0.43 between HTGW and IDF, and 0.59 between NCEP ATP III and IDF. The prevalence of the metabolic syndrome according to the HTGW in the sample was 16.8%, 18.3% in men and 15.4% in women. According to NCEP ATP IlI prevalence were respectively 20.3%, 20.9%, and 19.7%. According to IDF they were respectively 28.4%, 33%, and 23.9%. We recommend paying the same attention to the metabolic syndrome than to the traditional cardiovascular risk factors, and we recommend the use of the HTGW definition as diagnostic tool.

  13. Trade, TRIPS, and pharmaceuticals.

    Science.gov (United States)

    Smith, Richard D; Correa, Carlos; Oh, Cecilia

    2009-02-21

    The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus.

  14. 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

  15. Obstacles and opportunities in Chinese pharmaceutical innovation.

    Science.gov (United States)

    Ni, Jingyun; Zhao, Junrui; Ung, Carolina Oi Lam; Hu, Yuanjia; Hu, Hao; Wang, Yitao

    2017-03-24

    Global healthcare innovation networks nowadays have expanded beyond developed countries with many developing countries joining the force and becoming important players. China, in particular, has seen a significant increase in the number of innovative firms and research organizations stepping up to the global network in recent years. Nevertheless, the intense Research and Development input has not brought about the expectable output. While China is ascending at a great speed to a leading position worldwide in terms of Research and Development investment, scientific publications and patents, the innovation capabilities in the pharmaceutical sector remain weak. This study discusses the challenges and opportunities for pharmaceutical innovation in China. One hand, academic, industrial, institutional and financial constraints were found to be the major and inevitable barriers hindering the development of drug innovation. On the other hand, unique advantages had been observed which included growing pharmaceutical market, Research and Development funding, distinctive source, and international cooperation. The most important thing for China's pharmaceutical sector to leap forward is to break though innovation barriers and integrate own advantages into global value-chain of healthcare product development.

  16. Pharmaceutical technology, biopharmaceutics and drug delivery.

    Science.gov (United States)

    Youn, Yu Seok; Lee, Beom-Jin

    2011-03-01

    The 40th annual international conference of the Korean Society of Pharmaceutical Sciences and Technology on Pharmaceutical Technology, Biopharmaceutics and Drug Delivery was held on 2-3 December 2010 in Jeju Special Self-Governing Providence, Korea, to celebrate its 40th anniversary. A comprehensive review of a wide spectrum of recent topics on pharmaceutical technology, biopharmaceutics and drug delivery was presented. Invited lectures and poster presentations over 2 days were divided into six parallel sessions covering areas such as biotechnology, biopharmaceutics, drug delivery, formulation/manufacture, regulatory science and frontier science. Among these, there were two sessions related to regulatory science and biopharmaceutics that were co-sponsored by the Korea Food and Drug Administration. In fact, this conference provided an opportunity for many investigators to discuss their research, collect new information and to promote the advancement of knowledge in each pharmaceutical area. This conference report summarizes the keynote podium presentations provided by many distinguished speakers, including Gordon L Amidon of the University of Michigan.

  17. Assessing the Understanding of Pharmaceutical Pictograms among Cultural Minorities: The Example of Hindu Individuals Communicating in European Portuguese.

    Science.gov (United States)

    Kanji, Lakhan; Xu, Sensen; Cavaco, Afonso

    2018-03-05

    One of the sources of poor health outcomes is the lack of compliance with the prescribed treatment plans, often due to communication barriers between healthcare professionals and patients. Pictograms are a form of communication that conveys meaning through its pictorial resemblance to a physical object or an action. Pharmaceutical pictograms are often associated with a better comprehension of treatment regimens, although their use is still subject to limitations. The main goal of this study was to examine the potential understanding of pharmaceutical pictograms by a cultural minority when providing patient information while comparing the effectiveness of two reference systems (United States Pharmacopeia USP and International Pharmacy Federation FIP) for this purpose. A self-administered questionnaire was developed comprising 30 pictograms, 15 selected from the United States Pharmacopeia Dispensing Information and the equivalent from the International Pharmaceutical Federation. The questionnaire comprised plain instructions, socio-demographic data, self-reported language fluency and pictogram labels in Portuguese presented to conveniently selected members of the Hindu community of Lisbon (Portugal) until reaching a quota of 50. Participants showed difficulties in understanding some pictograms, which was related to the self-reported reduced fluency in Portuguese. Overall, the interpretation of USP pictograms was better than FIP ones, as well as for pictograms composed of multiple images, presenting a negative reading, or when conveying information unrelated to medication instructions. Even using internationally validated pictograms, added care should be taken when community pharmacists use such communication resources with cultural minorities. It is important not to disregard other forms of patient communication and information, considering pictograms as a complement to other forms of patient counselling.

  18. 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…

  19. [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.

  20. 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.

  1. 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

  2. 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)

  3. Effective executive management in the pharmaceutical industry.

    Science.gov (United States)

    Tran, Hoang; Kleiner, Brian H

    2005-01-01

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

  4. Prevalence and cardiovascular disease risk of the metabolic syndrome using National Cholesterol Education Program and International Diabetes Federation definitions in the Korean population.

    Science.gov (United States)

    Choi, Kyung Mook; Kim, Seon Mee; Kim, Yeong-Eun; Choi, Dong Seop; Baik, Sei Hyun; Lee, Juneyoung

    2007-04-01

    To compare the prevalence of the metabolic syndrome using the National Cholesterol Education Program (NCEP) and the International Diabetes Federation (IDF) definitions and to contrast the association between the prevalence of cardiovascular disease and the metabolic syndrome using both definitions in the Korean population, we used data from the 2001 Korean Nation Health and Nutrition Survey, which is a nationally representative survey of the noninstitutionalized civilian population. The age-adjusted prevalence of the metabolic syndrome was 18.8%+/-0.5% (men, 17.8%+/-0.8%; women, 20.5%+/-0.7%) using the NCEP definition and 19.5%+/-0.5% (men 15.0%+/-0.8%, women 23.9%+/-0.7%) using the IDF definition among participants 20 years or older. The agreement rate, which is the percentage of participants who were classified as either having or not having the metabolic syndrome by both definitions of the metabolic syndrome, was 84.6%+/-0.5% (kappa=0.54). The prevalence of the metabolic syndrome using the NCEP definition was higher in participants with lower body mass index, whereas the prevalence using the IDF definition was higher in subjects with higher body mass index. The odds ratio (OR) for coronary artery disease was 3.5 (95% confidence interval [CI], 2.0-6.1) for participants with the metabolic syndrome defined by the NCEP definition, whereas it was 2.8 (95% CI, 1.6-5.0) for those with the metabolic syndrome defined by the IDF definition. Similarly, the OR for stroke was higher using the NCEP definition (OR, 3.0; 95% CI, 1.7-5.2) compared with that of the IDF definition (OR, 2.3; 95% CI, 1.3-4.0). However, the CIs by both definitions overlapped considerably. In conclusion, the prevalence of the metabolic syndrome using the IDF definition was higher than that using the NCEP definition, whereas the NCEP definition was more closely associated with cardiovascular disease in the Korean population.

  5. 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.

  6. An evaluation of the International Diabetes Federation definition of metabolic syndrome in Chinese patients older than 30 years and diagnosed with type 2 diabetes mellitus.

    Science.gov (United States)

    Lu, Bin; Yang, Yehong; Song, Xiaoyan; Dong, Xuehong; Zhang, Zhaoyun; Zhou, Linuo; Li, Yiming; Zhao, Naiqing; Zhu, XiXing; Hu, Renming

    2006-08-01

    The objective of the study was to determine the most accurate metabolic syndrome (MS) definition among the definitions proposed by the International Diabetes Federation (IDF), the 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 [ATPIII]), and the World Health Organization (WHO) and to evaluate the cutoff point of waist circumference using the IDF definition for optimally defining MS in the Chinese population. One thousand thirty-nine Chinese patients older than 30 years and diagnosed with type 2 diabetes mellitus were investigated by randomized cluster sampling in the Shanghai downtown, and 1008 patients were analyzed in this study. Body mass measurements, resting blood pressure, fasting blood measures, and carotid atherosclerotic measurements including common carotid artery intima-media thickness (IMT) and carotid plaque were investigated. The IDF definition was compared with the other 2 definitions, and the carotid atherosclerosis was evaluated among the patients according to these definitions. (1) The MS prevalence was 50.0%, 55.7%, and 70.0% under the IDF, ATPIII, and WHO definitions, respectively. (2) The percentage of all the participants categorized as either having or not having the MS was 69.9% (under the IDF and ATPIII definitions) and 70.2% (under the IDF and WHO definitions). (3) Common carotid artery IMT of patients with MS determined by the IDF definition was thicker than those determined by the WHO and ATPIII definitions, and the percentage of carotid plaque of patients with MS determined by the IDF definition was greater than those determined by the WHO and ATPIII definitions. (4) When the cutoff point of waist circumference in men determined by the IDF definition was modified from 90 to 85 cm, common carotid artery IMT of the emerging male patients with MS was thicker than that of the male patients with MS determined by the

  7. 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.

    Science.gov (United States)

    Rodríguez, Angel; Delgado-Cohen, Helena; Reviriego, Jesús; Serrano-Ríos, Manuel

    2010-12-16

    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. 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). A logistic regression model was used to identify demographic, clinical, and lifestyle variables related with metabolic syndrome (N = 1259). Hypertension, dyslipidemia, and glycosylated hemoglobin (HbA(1c)) ≥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). The risk factors for metabolic syndrome in type 2 diabetes mellitus patients are highly dependent on the criteria used to define the syndrome, supporting the need for a single clinically useful and epidemiologically useful definition.

  8. How Radio Frequency Identification Improves Pharmaceutical Industry: A Comprehensive Review Literature

    Directory of Open Access Journals (Sweden)

    Roxana Sharifian

    2016-05-01

    Full Text Available According to the vital role of pharmaceutical industry in health care system, pharmaceutical supply chain security, standard production and distribution of the pharmaceutical products are of great importance for pharmaceutical companies. Therefore, applying technology, especially Radio Frequency Identification (RFID, is essential to achieve these goals. Moreover, due to the importance of security in production and distribution and also the quality of pharmaceutical products, international pharmaceutical Institutes such as Food and Drug Administration (FDA and huge pharmaceutical companies apply RFID to increase their success and improve their efficiency and effectiveness. The present study explains the concept of RFID, its application and importance in pharmaceutical industry, and its role in struggling against counterfeit medicines in addition to presenting a framework of RFID in struggling against counterfeit medicines. It is discussed that RFID has various applications in pharmaceutical industry such as inventory and property management system, access control and machines’ performances, producing sterile pharmaceutical products, anti-thieving mechanism, preventing medicines’ diversion.Counterfeit medicines and recognition of counterfeit medicines. As a conclusion RFID can be suggested to make the pharmaceutical industry and health system smart. Therefore, it is suggested to establish this technology in pharmaceutical supply chain by the use of Information Technology and create a team of related specialists in order to successful application of this technology and gain the positive related results.

  9. 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

  10. 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...

  11. 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)

  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. The argument for pharmaceutical policy

    DEFF Research Database (Denmark)

    Traulsen, Janine Morgall; Almarsdóttir, Anna Birna

    2005-01-01

    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...... 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...

  14. 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.

  15. [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.

  16. Results of a survey on applied quality standards in non-interventional studies among the members of the German Association of Research-based Pharmaceutical Companies

    Science.gov (United States)

    Hahn, Michael; Ruppert, Thorsten; Bethke, Thomas D.; Hundt, Ferdinand

    2010-01-01

    After the regulatory approval has been obtained, epidemiological studies are acknowledged scientific medical research methods for a new drug which provide additional knowledge about routine application of the drug in clinical daily routine. These studies are performed according to the recommendations of both international and national expert associations, the recommendations of the higher federal authorities in Germany and according to the recommendations of the associations of the pharmaceutical industry. Two surveys among the member companies of the Association of Research-based Pharmaceutical Companies investigated the status of the implementation of the recommendations in the years 2008 and 2010 and compared the results with each other. It could be shown that these recommendations were implemented successfully and were fully adhered to during the conduct of non-interventional studies in Germany. The recommendations define a quality standard which justifies a high level of confidence in the validity of the data collected and the results from these investigations. PMID:21063466

  17. 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.)

  18. 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.

  19. 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...

  20. Nigerian Journal of Pharmaceutical Research

    African Journals Online (AJOL)

    The Nigerian Journal of Pharmaceutical Research publishes scientific work in all areas of Pharmaceutical and life sciences, including (but not restricted to): medicinal ... Evaluation of viability of lactic acid bacteria in a Nigerian commercial yogurt and its antagonistic effects on selected strains of diarrheagenic Eschericia coli ...

  1. Pharmaceutical study of Yashadabhasma.

    Science.gov (United States)

    Bhojashettar, Santhosh; Jadar, P G; Rao, V Nageswara

    2012-01-01

    Rasashastra is a branch which deals with the pharmaceutics of Rasaoushadhis. Bhasmas are one among such Rasaoushadhis which are known for their low doses and fast action. A verse from Rasaratnasamuchchaya says that the bhasma prepared by using Mercury as media is of best quality. Following this principle, Yashadabhasma (Zinc calx) was prepared by subjecting it to Samanya shodhana (general purification method for all metals), Vishesha shodhana (specific putification method for Zinc), Jarana (roasting) and Marana (incineration) with Parada(Mercury) as a media under Gajaputa (classical heating system with 1000 cowdung cakes). Yellow colored Yashadabhasma which passed all the classical bhasmaparikshas (tests for properly prepared calx) was obtained after two putas. The bhasma did not pass Nishchandratva(free from shining particles) test after 1(st)puta but was passed after giving it 2(nd)puta.

  2. Making Progress and Gaining Momentum in Global 3Rs Efforts: How the European Pharmaceutical Industry Is Contributing

    Science.gov (United States)

    Fleetwood, Gill; Chlebus, Magda; Coenen, Joachim; Dudoignon, Nicolas; Lecerf, Catherine; Maisonneuve, Catherine; Robinson, Sally

    2015-01-01

    Animal research together with other investigational methods (computer modeling, in vitro tests, etc) remains an indispensable part of the pharmaceutical research and development process. The European pharmaceutical industry recognizes the responsibilities inherent in animal research and is committed to applying and enhancing 3Rs principles. New nonsentient, ex vivo, and in vitro methods are developed every day and contribute to reducing and, in some instances, replacing in vivo studies. Their utility is however limited by the extent of our current knowledge and understanding of complex biological systems. Until validated alternative ways to model these complex interactions become available, animals remain indispensable in research and safety testing. In the interim, scientists continue to look for ways to reduce the number of animals needed to obtain valid results, refine experimental techniques to enhance animal welfare, and replace animals with other research methods whenever feasible. As research goals foster increasing cross-sector and international collaboration, momentum is growing to enhance and coordinate scientific innovation globally—beyond a single company, stakeholder group, sector, region, or country. The implementation of 3Rs strategies can be viewed as an integral part of this continuously evolving science, demonstrating the link between science and welfare, benefiting both the development of new medicines and animal welfare. This goal is one of the key objectives of the Research and Animal Welfare working group of the European Federation of Pharmaceutical Industries and Associations. PMID:25836966

  3. 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

  4. Packaging and Labeling of Pharmaceutical Products Obtained from the Internet

    Science.gov (United States)

    2011-01-01

    Background 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. Objective 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. Methods 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. Results 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

  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. 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...... contract be- tween a private pharmaceutical enterprise and a public research university (or a private university conducting publicly funded research) to support research leading to new commercial pharmaceutical and biologic products. The key purpose of this article is to provide a theoretical explanation...... 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...

  7. 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.

  8. 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...

  9. [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.

  10. 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.

  11. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA).

    Science.gov (United States)

    Hernlund, E; Svedbom, A; Ivergård, M; Compston, J; Cooper, C; Stenmark, J; McCloskey, E V; Jönsson, B; Kanis, J A

    2013-01-01

    This report describes the epidemiology, burden, and treatment of osteoporosis in the 27 countries of the European Union (EU27). Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased risk of fragility fractures which represent the main clinical consequence of the disease. Fragility fractures are associated with substantial pain and suffering, disability and even death for affected patients and substantial costs to society. The aim of this report was to characterize the burden of osteoporosis in the EU27 in 2010 and beyond. The literature on fracture incidence and costs of fractures in the EU27 was reviewed and incorporated into a model estimating the clinical and economic burden of osteoporotic fractures in 2010. Twenty-two million women and 5.5 million men were estimated to have osteoporosis; and 3.5 million new fragility fractures were sustained, comprising 610,000 hip fractures, 520,000 vertebral fractures, 560,000 forearm fractures and 1,800,000 other fractures (i.e. fractures of the pelvis, rib, humerus, tibia, fibula, clavicle, scapula, sternum and other femoral fractures). The economic burden of incident and prior fragility fractures was estimated at 37 billion. Incident fractures represented 66 % of this cost, long-term fracture care 29 % and pharmacological prevention 5 %. Previous and incident fractures also accounted for 1,180,000 quality-adjusted life years lost during 2010. The costs are expected to increase by 25 % in 2025. The majority of individuals who have sustained an osteoporosis-related fracture or who are at high risk of fracture are untreated and the number of patients on treatment is declining. In spite of the high social and economic cost of osteoporosis, a substantial treatment gap and projected increase of the economic burden driven by the aging populations, the use of pharmacological interventions to prevent fractures has decreased in recent years, suggesting that a change in healthcare policy is warranted.

  12. 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...

  13. [Counterfeit pharmaceuticals in Peru].

    Science.gov (United States)

    Exebio, Luis E Moreno; Rodríguez, Javier; Sayritupac, Freddy

    2010-02-01

    To determine the quantity of counterfeit pharmaceutical drugs found by the National Quality Control Center (Centro Nacional de Control de Calidad (CNCC), Instituto Nacional de Salud, Peru) during the period from 2005&2008, and the types and properties of these drugs. A form was created to amass the relevant data collected directly from CNCC reports. The reports underwent a review and analysis process, and where counterfeiting was confirmed, it was categorized by type into one of four groups. The percentage of counterfeit drugs relative to the total drugs evaluated was: 3.0% in 2005, 5.0% in 2006, 7.3% in 2007, and 9.2% in 2008. The main groups of counterfeit drugs, classified according to the World Health Organization Anatomical Therapeutic Chemical Classification System, were: alimentary tract and metabolism, 34.5% (29.1%-39.8%); antiinfectives for systemic use, 21.1% (16.5%-25.7%); nervous system, 17.1% (12.8%-21.3%); and musculo-skeletal system, 15.4% (11.3%-19.5%). The most common type of forgery occurred in cases where the drug contained the correct amount of active ingredients, but the manufacturer was one other than the one indicated (62.4% of the total counterfeit drugs); and medications that did not contain any active ingredient (22.4%). Of the counterfeit drugs, 61.0% (56.0%-67.0%) were national brands and 39.0%, (33.0%-44.0%) were imported. The pharmaceutical formulations with the highest rate of forgery were tablets, 66.0% (60.0%-71.0%); injectables, 19.0% (14.0%-23.0%); and capsules 7.0% (4.0%-10.0%). From 2005-2008, drug counterfeiting had an average annual variation of 45%. Drug counterfeiting was shown to be most prevalent among national brands - as opposed to imported medications - although the types and formulations of the fake drugs attest to a certain level of sophistication employed in the forgery process. The counterfeiting of life-saving drugs, such as antimicrobials, signifies a serious public health threat.

  14. Radionuclides in pharmaceutical researches

    International Nuclear Information System (INIS)

    Khujaev, S.

    2005-01-01

    Full text: The development of modern stage of nuclear medicine is characterized by the increasing role of methods using radionuclides. Radioactive nuclides used in nuclear medicine may be divided into 2 groups. Radionuclides used for diagnostic researches and radionuclides used for therapeutic purposes. These two directions are considered to be the main ones in usage of radionuclides in medicine. However there is one more direction in the research of new medical products where it is possible to use radionuclides to study their pharmacological kinetics. In these researches radionuclide is applied as a radioactive label at the stage of studying pharmacological kinetics of a new medical product. In Institute of Nuclear Physics AS RUz the works are being carried out in the recent years focused on studying pharmacology of some new medical preparations, which are synthesized in Tashkent Pharmaceutical Institute. Syntheses these preparations are based on use microelements. Its compounds are possessed expressed biological activity and be of great importance in the pharmaceutical science of Uzbekistan. Introducing a radioisotope at the stage of synthesis carried out reception of labeled connections of all preparations. The output of the final product reached the yield of no less than 80 % in all cases of synthesis. This work presents the results of research on synthesis and study of pharmacology of radioactively labeled preparations - Piracin, labeled by radioisotope 69m Zn; Pheramed, labeled by radioisotope 59 Fe; Cobavit, labeled by radioisotope 57 Co; VUC, labeled by radioisotope 57 Co, CO-101, labeled by radioisotope 57 Co. Received radioisotope - labeled compounds of medical preparations were used in the study of their pharmacological kinetics on experimental rats. In all cases, preliminary irradiation of corresponding nuclear targets in the nuclear reactor and cyclotron, radiochemical procedures on separation, purification and concentration oi radioactive isotopes

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 77 FR 69634 - International Conference on Harmonisation; Guidance on Q11 Development and Manufacture of Drug...

    Science.gov (United States)

    2012-11-20

    ... 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... years, many important initiatives have been undertaken by regulatory authorities and industry...

  20. 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

  1. Cyclodextrins as pharmaceutical solubilizers.

    Science.gov (United States)

    Brewster, Marcus E; Loftsson, Thorsteinn

    2007-07-30

    Cyclodextrins are useful functional excipients that have enjoyed widespread attention and use. The basis for this popularity from a pharmaceutical standpoint, is the ability of these materials to interact with poorly water-soluble drugs and drug candidates resulting in an increase in their apparent water solubility. The mechanism for this solubilization is rooted in the ability of cyclodextrin to form non-covalent dynamic inclusion complexes in solution. Other solubilizing attribute may include the ability to form non-inclusion based complexes, the formation of aggregates and related domains and the ability of cyclodextrins to form and stabilize supersaturated drug solutions. The increase in solubility also can increase dissolution rate and thus improve the oral bioavailability of BCS Class II and IV materials. A number of cyclodextrin-based products have reached the market based on their ability to camouflage undesirable physicochemical properties. This review is intended to give a general background to the use of cyclodextrin as solubilizers as well as highlight kinetic and thermodynamic tools and parameters useful in the study of drug solubilization by cyclodextrins.

  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. OSI-774 OSI Pharmaceuticals.

    Science.gov (United States)

    Norman, P

    2001-02-01

    OSI-774 (formerly CP-358774), a quinazoline derivative, is an orally active epidermal growth factor receptor (EGFR) inhibitor which was originally under joint development by Pfizer and OSI Pharmaceuticals (formerly Oncogene Science) for the potential treatment of cancer (eg, ovarian, non-small cell lung cancer (NSCLC) and head and neck). It is being evaluated in phase II trials [304305], [372201]. On 8 January 2001, OSI announced that it had signed an agreement with Roche and Genentech for the global co-development and marketing of OSI-774. The agreement with Genentech covers the United States, that with Roche the rest of the world [395371], [395526]. In June 2000, OSI gained all development and marketing rights for OSI-774 following Pfizer's merger with Warner-Lambert [371439]. In September 2000, Pfizer transferred the IND dossierfor OSI-774 to OSI ahead of the timeline agreed in the June 2000 development and marketing rights agreement [383786]. The phase II trials will assess OSI-774 both as a single agent and in combination with existing chemotherapy regimens [347783]. Phase III trials are expected to be initiated in 2001 [347783]. In October 2000, Lehman Brothers predicted that OSI-774 would move into pivotal trials in thefirst half of 2001 and that the drug would be launched in 2003. The analysts also estimated worldwide sales of US $66 million, $285 million and $461 million in 2003, 2004 and 2005, respectively, and peak sales in excess of US $500 million [395189].

  4. 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

  5. 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...... in the Western literature? Second, are there any problems with existing principles of fiscal federalism and, if so, how to refine them? Third, how are refined principles relevant to the Chinese case and what policies should the Chinese government pursue in the future? Based on an in-depth and critical review...

  6. 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

  7. 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.

  8. 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.

  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. 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.

  11. 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

  12. 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 5, No 1 (2006) >. Log in or Register to get access to full text downloads.

  13. 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...

  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. Practice of pharmaceutical care in community pharmacies in Jordan

    African Journals Online (AJOL)

    (DOAJ), African Journal Online, Bioline International, Open-J-Gate and Pharmacy Abstracts. INTRODUCTION. Pharmaceutical care (PC) is .... customers, such as drug indications, dosage forms, counselling on adherence and side ..... adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies.

  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. How Two Small Pharmacy Schools' Competency Standards Compare with an International Competency Framework and How Well These Schools Prepare Students for International Placements.

    Science.gov (United States)

    Hawboldt, John; Nash, Rose; FitzPatrick, Beverly

    2017-03-06

    International standards of pharmacy curricula are necessary to ensure student readiness for international placements. This paper explores whether curricula from two pharmacy programs, in Australia and Canada, are congruent with international standards and if students feel prepared for international placements. Nationally prescribed educational standards for the two schools were compared to each other and then against the International Pharmaceutical Federation (FIP) Global Competency Framework. Written student reflections complemented this analysis. Mapping results suggested substantial agreement between the FIP framework and Australia and Canada, with two gaps being identified. Moreover, the students felt their programs prepared them for their international placements. Despite differences in countries, pharmacy programs, and health-systems all students acclimatized to their new practice sites. Implications are that if pharmacy programs align well with FIP, pharmacists should be able to integrate and practise in other jurisdictions that also align with the FIP. This has implications for the mobility of pharmacy practitioners to countries not of their origin of training.

  18. 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...

  19. 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...

  20. 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?

  1. 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?

  2. 75 FR 44794 - Rendezvous International v.

    Science.gov (United States)

    2010-07-29

    ... From the Federal Register Online via the Government Publishing Office FEDERAL MARITIME COMMISSION Rendezvous International v. Chief Cargo Services, Inc., Kaiser Apparel, Inc., Edco Logistics, Inc., Oriental... complaint has been filed with the Federal Maritime Commission (``Commission'') by Rendezvous International...

  3. 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.

  4. 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

  5. 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.

  6. Deforestation: environmental impact and research needs. Joint hearing before the Subcommittee on Natural Resources, Agriculture Research and Environment of the Committee on Science and Technology and the Subcommittee on Human Rights and International Organizations of the Committee on Foreign Affairs, US House of Representatives, Ninety-Seventh Congress, Second Session, September 16, 1982

    Energy Technology Data Exchange (ETDEWEB)

    1983-01-01

    Witnesses from several federal agencies involved in international development and environmental concerns described the destabilizing global effects of tropical deforestation from carbon dioxide buildup and the loss of trees due to population pressures. The witnesses explained the environmental impacts and the research underway to minimize and manage the impacts of deforestation, such as the loss to pharmaceutical research. They emphasized the need for coordinating forestry and agriculture and of the importance of international cooperation among researchers. (DCK)

  7. Studies of international organizations in the Russian Federation. Interview with Doctor of political sciences, Professor, Director of the Center for International Institutions Research (CIIR of RANEPA M.V. Larionova

    Directory of Open Access Journals (Sweden)

    S A Bokeriya

    2017-12-01

    Full Text Available Marina V. Larionova is a leading Russian expert in studying international institutions. In 2007 she defended her doctoral thesis on the theme: “Creating a common educational space in conditions of the development of integration processes in the European Union” at the Peoples’ Friendship University of Russia. In the period from 2002 to 2009 Marina Vladimirovna held the position of Vice-Rector of the National Research University “Higher School of Economics”, and now she is currently a professor at the Department of World Economy of the Faculty of World Economy and World Politics at HSE. Also in 2005-2016 she headed the Institute of International Organizations and International Cooperation of this University. Since 2014 Marina Vladimirovna is the Managing Director and Vice President for International Cooperation of the Russian Union of Industrialists and Entrepreneurs. Since 2015 she also heads the Center for International Institutions Research (CIIR in RANEPA. M.V. Larionova has more than 70 scientific publications, is member of the Political Science Academy, University Association for Contemporary European Studies (UACES and the president of the Association of Experts in the field of international development assistance. Marina Vladimirovna is also the chief editor of the scientific journal the International Organisations Research Journal (IORJ, a member of the editorial board of the Vestnik RUDN. International relations and a member of the editorial board of Global Summitry Journal - GSJ. In the interview, M.V. Larionova speaks about studies of international institutions (organizations both in Russia and in the world, describes main schools and research methodology.

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

    CERN Document Server

    Nishijima, K

    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)

  10. Upstream biomanufacturing of pharmaceutical colchicine.

    Science.gov (United States)

    Sivakumar, Ganapathy

    2018-02-01

    The plant-based colchicine potentially affects major diseases such as cardiovascular events, cancers and gout. Gloriosa superba seeds are a conventional pharmaceutical source of colchicine. The demand for pharmaceutical-grade colchicine has increased due to the shortage of feasible upstream manufacturing, encompassing all stages in the processes of biosynthesis and biomanufacturing before the raw material is ready for purification. Consequently, developing sustainable upstream industrial colchicine biofactories is imperative, especially in curtailing drug costs. A new upstream bioprocess has been established, using specialized biorhizomes with comprehensive specific-enzymes that catalyze the construction of biogenic functionalized intermediates that are converted into colchicine. This review emphasizes a novel biorhizome approach for biomanufacturing pharmaceutical-grade natural colchicine, a biosynthetic pathway elucidation and its challenges to synthetic biotechnology.

  11. Chemistry in the Pharmaceutical Industry

    Science.gov (United States)

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

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

  12. 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

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

    Science.gov (United States)

    Matowe, Lloyd; Waako, Paul; Adome, Richard Odoi; Kibwage, Isaac; Minzi, Omary; Bienvenu, Emile

    2008-12-23

    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. 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. 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 effectiveness of a novel skills-building approach for

  14. 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.

  15. 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

  16. 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

  17. Fundamentals of quality assessment of molecular amplification methods in clinical diagnostics. International Federation of Clinical Chemistry Scientific Division Committee on Molecular Biology Techniques.

    Science.gov (United States)

    Neumaier, M; Braun, A; Wagener, C

    1998-01-01

    The increasing interest in molecular biology diagnostics is a result of the tremendous gain of scientific knowledge in genetics, made possible especially since the introduction of amplification techniques. High expectations have been placed on genetic testing, and the number of laboratories now using the relevant technology is rapidly increasing--resulting in an obvious need for standardization and definition of laboratory organization. This communication is an effort towards that end. We address aspects that should be considered when structuring a new molecular diagnostic laboratory, and we discuss individual preanalytical and analytical procedures, from sampling to evaluation of assay results. In addition, different means of controlling contamination are discussed. Because the methodology is in constant change, no general standards can be defined. Accordingly, this publication is intended to serve as a recommendation for good laboratory practice and internal quality control and as a guide to troubleshooting, primarily in amplification techniques.

  18. Modeling picking on pharmaceutical tablets

    Science.gov (United States)

    Swaminathan, Shrikant

    Tablets are the most popular solid dosage form in the pharmaceutical industry because they are cheap to manufacture, chemically and mechanically stable and easy to transport and fairly easy to control dosage. Pharmaceutical tableting operations have been around for decades however the process is still not well understood. One of the common problems faced during the production of pharmaceutical tablets by powder compaction is sticking of powder to the punch face, This is known as 'sticking'. A more specialized case of sticking is picking when the powder is pulled away form the compact in the vicinity of debossed features. In the pharmaceutical industry, picking is solved by trial and error which is an expensive, labor intensive and time consuming affair. The objective of this work was to develop, validate, and implement a modeling framework for predicting picking in powder compacts. The model was developed in Abaqus a commercially available finite element package. The resulting model was used to investigate the influence of debossed feature geometry viz. the stroke angle and degree of pre-pick, and, influence of lubricant on picking. (Abstract shortened by ProQuest.).

  19. Tropical Journal of Pharmaceutical Research

    African Journals Online (AJOL)

    We publish articles in pharmaceutical sciences and related disciplines (including biotechnology, cell and molecular biology, drug utilization including adverse drug events, medical and other life sciences, and related engineering fields). Although primarily devoted to original research papers, we welcome reviews on current ...

  20. 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

    International Nuclear Information System (INIS)

    Xie, Wen-Jia; Wu, Xiao; Xue, Ren-Liang; Lin, Xiang-Ying; Kidd, Elizabeth A.; Yan, Shu-Mei; Zhang, Yao-Hong; Zhai, Tian-Tian; Lu, Jia-Yang; Wu, Li-Li; Zhang, Hao; Huang, Hai-Hua; Chen, Zhi-Jian; Li, De-Rui; Xie, Liang-Xi

    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

  1. 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.

    Science.gov (United States)

    Xie, Wen-Jia; Wu, Xiao; Xue, Ren-Liang; Lin, Xiang-Ying; Kidd, Elizabeth A; Yan, Shu-Mei; Zhang, Yao-Hong; Zhai, Tian-Tian; Lu, Jia-Yang; Wu, Li-Li; Zhang, Hao; Huang, Hai-Hua; Chen, Zhi-Jian; Li, De-Rui; Xie, Liang-Xi

    2015-01-01

    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). 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. 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. 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. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. 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.

  3. 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.

  4. 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.

  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. Pediatric Exposures to Veterinary Pharmaceuticals.

    Science.gov (United States)

    Tomasi, Suzanne; Roberts, Kristin J; Stull, Jason; Spiller, Henry A; McKenzie, Lara B

    2017-03-01

    To describe the epidemiology of veterinary pharmaceutical-related exposures to children based on calls to a regional poison control center. A retrospective analysis of pediatric (≤19 years of age) exposures to pharmaceutical products intended for animal use, managed by a regional poison control center from 1999 through 2013, was conducted. Case narratives were reviewed and coded for exposure-related circumstances and intended species. Descriptive statistics were generated. From 1999 through 2013, the Central Ohio Poison Center received 1431 calls that related to a veterinary pharmaceutical exposure for children ≤19 years of age. Most of the pediatric calls (87.6%) involved children ≤5 years of age. Exploratory behavior was the most common exposure-related circumstance (61.4%) and ingestion accounted for the exposure route in 93% of cases. Substances commonly associated with exposures included: veterinary drugs without human equivalent (17.3%), antimicrobial agents (14.8%), and antiparasitics (14.6%). Based on substance and quantity, the majority of exposures (96.9%) were not expected to result in long-term or lasting health effects and were managed at home (94.1%). A total of 80 cases (5.6%) were referred to a health care facility, and 2 cases resulted in a moderate health effect. Children ≤5 years of age are most at risk for veterinary pharmaceutical-related exposures. Although most exposures do not result in a serious medical outcome, efforts to increase public awareness, appropriate product dispensing procedures, and attention to home storage practices may reduce the risk of veterinary pharmaceutical exposures to young children. Copyright © 2017 by the American Academy of Pediatrics.

  7. 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.

  8. 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

  9. [Report of the World Federation of Neurosurgical Societies (WFNS) international course and Cameroon Neurosurgery Society Congress (CNS) Yaoundé (Cameroon), 1st--4th October 2007].

    Science.gov (United States)

    Eyenga, V C; Ndoumbe, A; Eloundou, N J

    2008-04-01

    Neurosurgery remains a very marginal activity in sub-Saharan Africa. In this part of the world which counts nearly 40 countries, some do not have a single neurosurgeon, some have one to five, the number of ten neurosurgeons per country remaining an exception! In its concern of popularizing and of developing neurosurgery worldwide, the WFNS organized an international course in Africa, October 2007 2nd-3rd in Yaoundé (Cameroon). The Cameroon Neurosurgery Society (CNS) took this opportunity to organize its very first congress in the presence of the WFNS delegation from October 1st to 4th, 2007. The joint meeting with the WFNS was baptized the "African Week of Neurosurgery". This special event was a first in sub-Saharan Africa. The delegation of the WFNS, led by Professor J. Brotchi (Belgium) President of the WFNS, was made up of Professors A. Sousa (Brazil), Mr. Choux (France), N. Tribolet (Swiss), M. Arraez (Spain), A. Bricolo (Italy), A. Kamlichi (Morocco), G. Dechambenoit (France), K. Kalangu (Zimbabwe). Twenty three neurosurgeons coming from nine African countries (Cameroon, Nigeria, Gabon, Congo, Niger, Burkina Faso, Ivory Coast, Senegal, and Guinea) took an active part in work. The scientific success of this event led to the creation of the "Association of Neurological Surgeons of Africa (ANSA)" which will be the WFNS-Africa interface in order to insure the development of neurosurgery in Africa.

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

    African Journals Online (AJOL)

    Multinational pharmaceutical companies ('pharmas') import and produce pharmaceuticals and also conduct ... The Department of Trade and Industry National Industrial Policy Framework1 designates chemicals, plastic fabrication and pharmaceuticals as a key value chain. So a second question could be: Can South Africa ...

  11. 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

  12. 78 FR 19017 - Manufacturer of Controlled Substances; Notice of Application; Johnson Matthey Pharmaceutical...

    Science.gov (United States)

    2013-03-28

    ...; Notice of Application; Johnson Matthey Pharmaceutical Materials, Inc. Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on November 15, 2012, Johnson... Remifentanil (9739) II Sufentanil (9740) II The company plans to utilize this facility to manufacture small...

  13. 77 FR 16264 - Manufacturer of Controlled Substances, Notice of Registration; Johnson Matthey Pharmaceutical...

    Science.gov (United States)

    2012-03-20

    ..., Notice of Registration; Johnson Matthey Pharmaceutical Materials Inc. By Notice dated November 18, 2011, and published in the Federal Register on November 28, 2011, 76 FR 72974, Johnson Matthey... Sufentanil (9740) II The company plans to utilize this facility to manufacture small quantities of the listed...

  14. 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

  15. Tackling corruption in the pharmaceutical systems worldwide with courage and conviction.

    Science.gov (United States)

    Cohen, J C; Mrazek, M; Hawkins, L

    2007-03-01

    Poor drug access continues to be one of the main global health problems. Global inequalities in access to pharmaceuticals are caused by a number of variables including poverty, high drug prices, poor health infrastructure, and fraud and corruption--the latter being the subject of this article. There is growing recognition among policy makers that corruption in the pharmaceutical system can waste valuable resources allocated to pharmaceutical products and services. This, in turn, denies those most in need from life-saving or life-enhancing medicines. As a result, international organizations, including the World Health Organization and the World Bank are beginning to address the issue of corruption in the health sector broadly and the pharmaceutical system specifically. This is encouraging news for improving drug access for the global poor who are most harmed by corruption as they tend to purchase less expensive drugs from unqualified or illegal drug sellers selling counterfeit or sub-standard drugs. In our paper, we illuminate what are the core issues that relate to corruption in the pharmaceutical sector. We argue that corruption in the pharmaceutical system can be detrimental to a country's ability to improve the health of its population. Moreover, unless policy makers deal with the issue of corruption, funding allocated to the pharmaceutical system to treat health conditions may simply be wasted and the inequality between rich and poor in access to health and pharmaceutical products will be aggravated.

  16. The undiscovered Argentine pharmaceutical market.

    Science.gov (United States)

    Felix, P F; Thomas, R K; Pol, L G

    2001-01-01

    The Argentine health care system is more highly developed than most systems in Latin America and gives most of its citizens access to a reasonable level of care. Now after 50 years of government control the system is becoming privatized, which provides new possibilities for health care marketers. One company developed an innovative approach to pharmaceutical marketing in Argentina that, while perhaps not appropriate for the U.S. market, may reap rewards in certain cultures and provide lessons for others.

  17. Surface modification of pharmaceutical powders

    OpenAIRE

    Zhou, Qi

    2017-01-01

    This thesis describes a body of work to investigate a mechanical dry powder coating approach aiming to modify the surface properties of fine pharmaceutical powders. Powders were coated with magnesium stearate (MgSt) in order to improve their bulk powder properties such as flowability, fluidization and aerosolization. The flow characteristics of a cohesive milled lactose monohydrate powder (Pharmatose® 450M, VMD around 20 μm) were substantially improved by processing with 1% w/w magn...

  18. Pharmaceutical microparticle engineering with electrospraying

    DEFF Research Database (Denmark)

    Bohr, Adam; Wan, Feng; Kristensen, Jakob

    2015-01-01

    , acetone, and an anti-solvent, methanol, for PLGA were studied in different ratios. Properties of the spraying solutions were examined and the resulting microparticles were characterized with regard to size, morphology, porosity, solid state form, surface chemistry and drug release. Particle formation...... 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....

  19. Progress of Pharmaceutical Continuous Crystallization

    Directory of Open Access Journals (Sweden)

    Dejiang Zhang

    2017-06-01

    Full Text Available Crystallization is an important unit operation in the pharmaceutical industry. At present, most pharmaceutical crystallization processes are performed in batches. However, due to product variability from batch to batch and to the low productivity of batch crystallization, continuous crystallization is gaining increasing attention. In the past few years, progress has been made to allow the products of continuous crystallization to meet different requirements. This review summarizes the progress in pharmaceutical continuous crystallization from a product engineering perspective. The advantages and disadvantages of different types of continuous crystallization are compared, with the main difference between the two main types of crystallizers being their difference in residence time distribution. Approaches that use continuous crystallization to meet different quality requirements are summarized. Continuous crystallization has advantages in terms of size and morphology control. However, it also has the problem of a process yield that may be lower than that of a batch process, especially in the production of chirality crystals. Finally, different control strategies are compared.

  20. [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.

  1. 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

  2. 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

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

    Science.gov (United States)

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

    2009-01-01

    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 absence of conflict of

  4. Globalization of the pharmaceutical industry: the physician's role in evaluating drug safety.

    Science.gov (United States)

    Beg, M M

    1990-11-01

    The trend toward uniformity of drug registration procedures due to imminent European Economic Community globalization has encouraged pharmaceutical companies to conduct studies on a worldwide basis. This standardization of methods will facilitate the "poolability" of efficacy and safety data generated by these international studies into a common database. With the internationalization of the pharmaceutical marketplace, physicians in industry may be required to collect and interpret such reports from all over the globe. The globalization of the pharmaceutical industry will thus broaden the opportunities for physician involvement in safety detection.

  5. 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.

  6. 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.

  7. 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.

  8. Engineering automated systems for pharmaceutical manufacturing: quality, regulations and business performance

    OpenAIRE

    Meagher, Diarmuid P.

    2006-01-01

    The pharmaceutical sector is very heavily regulated Drug safety regulations form one of the pillars of this regulation. The manufacture of pharmaceuticals is carried out in an environment of onerous regulatory requirements, often from several national and international regulatory bodies. The quality systems operated by drug manufacturers and their regulatory practices have an important impact on product quality. The quality and regulatory requirements apply not only to handling of the medicin...

  9. 77 FR 76414 - William D. Ford Federal Direct Loan Program

    Science.gov (United States)

    2012-12-28

    ... Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys . At this site you... exempt from taxation under section 501(a) of the Internal Revenue Code; and [[Page 76415

  10. 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...

  11. 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)

  12. The Federal Forecasters Conference--1999. Papers and Proceedings (10th, Washington, DC, June 24, 1999) and Selected Papers from the International Symposium on Forecasting (19th, Washington, DC, June 27-30, 1999).

    Science.gov (United States)

    Gerald, Debra E., Ed.

    The 10th Federal Forecasters Conference provided a forum where 127 forecasters from different federal agencies and other organizations met to discuss various aspects of the conference's theme, "Forecasting in the New Millennium," that could be applied in the United States. A keynote address, "Procedures for Auditing Federal Forecasts" by J. Scott…

  13. 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.

  14. 75 FR 10487 - International Conference on Harmonisation; Guidance on S9 Nonclinical Evaluation for Anticancer...

    Science.gov (United States)

    2010-03-08

    ... 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...

  15. 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...

  16. 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...

  17. 76 FR 38187 - International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of...

    Science.gov (United States)

    2011-06-29

    ... 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...

  18. 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.

  19. Kaolinite in pharmaceutics and biomedicine.

    Science.gov (United States)

    Awad, Mahmoud E; López-Galindo, Alberto; Setti, Massimo; El-Rahmany, Mahmoud M; Iborra, César Viseras

    2017-11-25

    Kaolinite Al 2 Si 2 O 5 (OH) 4 is an abundant and inexpensive geomaterial regarded as one of the most common clay minerals in the earth's crust and the most widespread phase among the other kaolin polymorphs (halloysite, dickite and nacrite). Structurally, it is a hydrous aluminum phyllosilicate member belonging to the dioctahedral 1:1 kaolin mineral group. The particle size of the pseudohexagonal kaolinite platelets is normally kaolinite platelets, either stacked together with a common booklet-like shape in a highly ordered structure (well crystallized) or disordered structure (poorly crystallized), consist of layers considered as a strong dipole of hydrophobic siloxane surface dominated by negative charges, and the other hydrophilic aluminol surface carries positive charges. Kaolinite has been used in many pharmaceutical applications as excipient or active ingredient, because it exhibits excellent physical, chemical and surface physicochemical properties. In addition to their classical pharmaceutical uses, kaolinite and its derivatives have been recently considered as a promising material in many biomedical innovation areas such as drug, protein and gene delivery based on the high interaction capacities with organic and biochemical molecules, bioadhesion and cellular uptake. Pharmaceutical kaolin grades are considerably demanded for usage as excipient in formulations of solid and semi-solid dosage forms. The most important functionalities of kaolin used as excipient are reported as diluent, binder, disintegrant, pelletizing and granulating, amorphizing, particle film coating, emulsifying and suspending agent. Because of its uninjured bioactivity, kaolinite has been also used as active agent for treatment of some common diseases. It can be topically administered as hemostatic agent, dermatological protector, anti-inflammatory agent and in pelotherapy, or orally as gastrointestinal protector, and antibacterial, antiviral, detoxification or antidiarrheal agent. With

  20. The New Unified International Diabetes Federation/American Heart Association/National Heart, Lung, and Blood Institute Metabolic Syndrome definition: does it correlate better with C-reactive protein in Chinese patients diagnosed with type 2 diabetes?

    Science.gov (United States)

    Lu, B; Zhang, S; Wen, J; Yang, Y; Yang, Z; Zhang, Z; Wang, X; Hu, R

    2010-01-01

    This study evaluated the association between high-sensitivity C-reactive protein (hsCRP) and metabolic syndrome, defined by the definition proposed by the International Diabetes Federation (IDF), American Heart Association (AHA) and National Heart, Lung, and Blood Institute (NHLBI) versus the older IDF definition, in 506 Chinese patients with type 2 diabetes. Anthropometric and biochemical parameters were compared and analysed using multivariate linear regression models. Serum hsCRP was higher in patients with metabolic syndrome compared with those without metabolic syndrome for both definitions and increased as the number of components of metabolic syndrome increased (after adjusting for age, gender and smoking). Patients with metabolic syndrome according to the IDF/AHA/NHLBI but not the IDF definition had significantly higher hsCRP levels than those not meeting either definition and similar hsCRP levels to those meeting both definitions. Serum hsCRP levels were significantly associated with metabolic syndrome according to the IDF definition after adjusting for age, gender and smoking. Adding metabolic syndrome status according to the IDF/AHA/NHLBI definition significantly increased the fit of the multivariate linear regression model. The new IDF/AHA/NHLBI definition of metabolic syndrome may have a stronger relationship with serum hsCRP than the IDF definition.

  1. Russian Federation Rising Power: Strengths and Weaknesses

    OpenAIRE

    KEITAN, Ahmed Yousif

    2017-01-01

    The ongoing developments in the Russian Federation since the beginning of the twenty-first century have been a dramatic turning point in its role at regional and international levels. A series of attempt to redraw the balances and become an international force that ultimately leads to its main goal of changing the balance of power in the system and building a new international order. The Russian diplomatic activity has evolved from competition, conflict, and cooperation with other internation...

  2. 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.

  3. 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.

  4. 16 February 2012 - Permanent Representative of the Russian Federation to the United Nations Office and other international organisations at Geneva Ambassador A.Borodavkin signing the the guest book with CERN Director-General R. Heuer; visiting ATLAS underground experimental area with Collaboration Members O. Fedin, S. Malyukov and A. Romaniouk; throughout accompanied by Adviser T. Kurtyka.

    CERN Multimedia

    Maximilien Brice

    2012-01-01

    16 February 2012 - Permanent Representative of the Russian Federation to the United Nations Office and other international organisations at Geneva Ambassador A.Borodavkin signing the the guest book with CERN Director-General R. Heuer; visiting ATLAS underground experimental area with Collaboration Members O. Fedin, S. Malyukov and A. Romaniouk; throughout accompanied by Adviser T. Kurtyka.

  5. Lubricants in Pharmaceutical Solid Dosage Forms

    OpenAIRE

    Jinjiang Li; Yongmei Wu

    2014-01-01

    Lubrication plays a key role in successful manufacturing of pharmaceutical solid dosage forms; lubricants are essential ingredients in robust formulations to achieve this. Although many failures in pharmaceutical manufacturing operations are caused by issues related to lubrication, in general, lubricants do not gain adequate attention in the development of pharmaceutical formulations. In this paper, the fundamental background on lubrication is introduced, in which the relationships between lu...

  6. Vulnerabilities to misinformation in online pharmaceutical marketing

    OpenAIRE

    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...

  7. 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.

  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. 75 FR 29744 - Federal Pell Grant, Federal Perkins Loan, Federal Work-Study, Federal Supplemental Educational...

    Science.gov (United States)

    2010-05-27

    ..., section 601 of the College Cost Reduction and Access Act of 2007 (CCRAA, Pub. L. 110-84) amended sections.... Education Savings and Asset Protection Allowance. This allowance protects a portion of net worth (assets... DEPARTMENT OF EDUCATION Federal Pell Grant, Federal Perkins Loan, Federal Work-Study, Federal...

  10. 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…

  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. 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.

  13. 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.

  14. 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.

  15. International Journal of Health Research: Submissions

    African Journals Online (AJOL)

    It seeks particularly (but not exclusively) to encourage pharmaceutical and allied research of tropical relevance and to foster multidisciplinary research and collaboration among scientists, the pharmaceutical industry and the healthcare professionals. It will also provide an international forum for the communication and ...

  16. [Pharmacy, pharmacists and society--pharmaceutical science and practice with philosophy].

    Science.gov (United States)

    Nagai, Tsuneji

    2003-03-01

    In Japanese pharmaceutical community, there seems to be a lack of "Science of Science" and "Research on Research" which are to utilize unit sciences and research for the benefit of human being. In other words, pharmaceutical people in Japan should have much more pharmaceutical philosophy. The late Professor Komei Miyaki, founder Editor-in-Chief of FARUMASHIA, the monthly membership magazine of Pharmaceutical Society of Japan, under whom I worked as one of editorial board members, taught me that scientists should have their own philosophy of their sciences. Such a pharmaceutical philosophy as mentioned above should be established on the basis of complete separation of medical profession between doctors and pharmacists, which form the most important and necessary issue in safety assurance for patients with the complete zero defect (ZD action), as there is a long history for that in Europe since the separation was completed by King Friedrich II in 1240. Therefore, we have to learn the social status of European/American pharmacist practitioners who are the great No. 1 among all the professions. European pharmacists guarantee the safety of every chemical used for human body and pets, such as medicines, cosmetics, foods, tooth stuffs and so on. Regarding the pharmaceutical sciences in Japan also there seems to be a lack of pharmaceutical philosophy, as pharmaceutical scientists have no identity in research object that may be similar to basic scientists who are non-pharmacy graduates. Japanese sciences generally have developed along the lines of the Western model, reaching the current high level. We now not only should receive profits from the outside but also should embark on a mission to support pharmaceutical sciences throughout the world, especially Asian courtiers. At the present, we do not seem to be fulfilling our mission to do that, even though general activity includes significant international exchange. We have to make much more effort for international

  17. Export Readiness Assessment of Ten Iranian Pharmaceutical Companies and Comparison with their Export Performance

    Directory of Open Access Journals (Sweden)

    Mehdi Mohammadzadeh, Mohammad Poloee, Tayebeh Ghari

    2016-09-01

    Full Text Available Background: In the area of exporting, in developing countries, including Iran, the concept of export readiness is unknown to many decision makers and field of activity of Iranian pharmaceutical companies have been limited to the domestic market. Therefore, the main objective of this study is to compare the export performance of ten Iranian pharmaceutical companies with their export readiness. Methods: In order to do this, the top ten of Iranian pharmaceutical companies were selected as the sample. The companies' export readiness was measured, and compared with their export volume as well as their export growth (as two factors for determining the export performance in five years, to practically check the model and find the strengths and weaknesses of these Iranian pharmaceutical companies in the export factors. Results: Base on the results of the study, the export readiness of these companies does not have significant correlation with companies' export volume in the current circumstances, but it can predict the export growth in the firm's export rate with 95% certainty. Conclusion: The most important thing is that according to the data collected in our study, most of these ten Iranian pharmaceutical companies are not ready to attend in exporting and international markets and only two companies were ready to export. It seems that making improvement in some variables like obtaining international standards, marketing and exporting education, having a transparent and documented plan and having the responsible person for export could increase export readiness of pharmaceutical companies.

  18. 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.

  19. 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

  20. Application of 19F NMR Spectroscopy for Content Determination of Fluorinated Pharmaceuticals

    Directory of Open Access Journals (Sweden)

    Alex O. Okaru

    2017-01-01

    Full Text Available A simple, rapid, and selective quantitative nuclear magnetic resonance spectroscopic method was evaluated for the determination of the content of fluorinated pharmaceuticals. 19F NMR spectra were either obtained in dimethylsulfoxide-d6 or aqueous buffer, using trifluoroacetic acid as internal standard. Quantification of 13 fluorine-containing pharmaceuticals spanning various pharmacological classes was accomplished using the proposed method. The method was found to be fit for purpose (interday precision 1.2% relative standard deviation and may thus be applied for routine analysis and quality control of fluorine-containing pharmaceuticals due to its simplicity, nondestructive sample measurement, reliability, and high specificity. Therefore, 19F NMR may serve as a suitable analytical tool for the identification and selective determination of fluorinated pharmaceuticals used as reference materials and bulk samples.

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

    Science.gov (United States)

    Yongue, Julia S

    2014-01-01

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

  2. Pharmaceutical marketing practices: balancing public health and law enforcement interests; moving beyond regulation-through-litigation.

    Science.gov (United States)

    Zalesky, Christopher D

    2006-01-01

    Fraudulent or abusive sales and marketing practices by pharmaceutical companies can result in costly overutilization of products that are increasingly paid for by government healthcare programs and may result in adverse health and safety consequences to the patient-beneficiaries of those programs. Federal enforcement efforts in this area are largely modeled on those used to combat white-collar crime, with cases taking years to reach conclusion. This approach overlooks the impact on patients who receive unnecessary care or are denied access to appropriate care during the course of the investigation. Many states are beginning to regulate certain pharmaceutical sales and marketing practices, but state-by-state regulation ignores the importance of a uniform federal regulatory and enforcement approach in an area already occupied by federal law. This Article explores current federal and state efforts to limit overutilization, fraud, and abuse in the sale and marketing of prescription drugs, and illustrates the merits of an expanded role for the U.S. Food and Drug Administration (FDA) to regulate pharmaceutical sales and marketing practices. This approach borrows lessons learned from the FDA's efficient and effective regulatory and enforcement methods and maintains a careful balance between the interests of patient-beneficiaries, the government and industry.

  3. Patients Comprehension of Pharmaceutical Package Inserts ...

    African Journals Online (AJOL)

    Patients Comprehension of Pharmaceutical Package ... Tropical Journal of Pharmaceutical Research is indexed by Science Citation Index (SciSearch), Scopus, ... of problem in reading and understanding of PPI by patients [7-9]. It is imperative to know the perception of patients/consumers about PPI. Such type of.

  4. 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.

  5. 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 way to attain self-sufficiency in drug supplies, improve access to medicine, and create job opportunities. Their call to action is reflected in the Pharmaceutical Manufacturing Plan for Africa. It is also found at the sub-regional levels, including the ...

  6. Assessment of Human Pharmaceutical Products Registered in ...

    African Journals Online (AJOL)

    The aim of this study was to assess the human pharmaceutical products that have been registered in Kenya in order to determine the most common routes of administration and type of dosage forms that are used. Registered pharmaceutical products were categorized by route of administration and then sub-categorized by ...

  7. Integrating systems Approaches into Pharmaceutical Sciences

    DEFF Research Database (Denmark)

    Westerhoff, H.V.; Mosekilde, Erik; Noe, C. R.

    2008-01-01

    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...

  8. 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.

  9. Recent advances in pharmaceutical sciences VII

    OpenAIRE

    Muñoz-Torrero López-Ibarra, Diego; Riu Aumatell, Montserrat; Feliu José, Carlos

    2017-01-01

    The E-book series Recent Advances in Pharmaceutical Sciences reports research contributions from different areas of the multidisciplinary field of Pharmaceutical Sciences. This seventh volume consists of nine chapters, mainly dealing with the fields of botany, physiology, food science, biochemistry & molecular biology, plant physiology, microbiology, parasitology, pharmacology, and medicinal chemistry.

  10. 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

  11. 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 ...

  12. Archives: Journal of Pharmaceutical and Allied Sciences

    African Journals Online (AJOL)

    Items 1 - 34 of 34 ... Archives: Journal of Pharmaceutical and Allied Sciences. Journal Home > Archives: Journal of Pharmaceutical and Allied Sciences. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register · Journal Home · ABOUT THIS JOURNAL · Advanced Search ...

  13. To protect peptide pharmaceuticals against peptidases

    NARCIS (Netherlands)

    Rink, R.; Arkema-Meter, A.; Baudoin, I.; Post, E.; Kuipers, A.; Nelemans, S. A.; Akanbi, M. Haas Jimoh; Moll, G. N.

    2010-01-01

    Introduction: The major hurdle in the application and delivery of peptide pharmaceuticals is their rapid in vivo breakdown. Methods: We here combined two approaches to stabilize peptide pharmaceuticals, introduction of D-amino acids and cyclization, by applying an innovative enzymatic method. This

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

    Science.gov (United States)

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

    2016-06-01

    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. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. 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.

  17. 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...... and release testing studies. The review covers the basic principles of the technology and summarizes the main applications in relation to intrinsic dissolution rate determination, excipient compatibility studies and in vitro release characterization of drug substances and vehicles intended for parenteral...... administration. UV imaging has potential for providing new insights to drug dissolution and release processes in formulation development by real-time monitoring of swelling, precipitation, diffusion and partitioning phenomena. Limitations of current instrumentation are discussed and a perspective to new...

  18. 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.

  19. Comparison of the prevalence of metabolic syndrome and its association with diabetes and cardiovascular disease in the rural population of Bangladesh using the modified National Cholesterol Education Program Expert Panel Adult Treatment Panel III and International Diabetes Federation definitions

    Science.gov (United States)

    Bhowmik, Bishwajit; Afsana, Faria; Siddiquee, Tasnima; Munir, Sanjida B; Sheikh, Fareeha; Wright, Erica; Bhuiyan, Farjana R; Ashrafuzzaman, Sheikh Mohammad; Mahtab, Hajera; Azad Khan, Abul Kalam; Hussain, Akhtar

    2015-01-01

    Aims/Introduction To compare the prevalence of metabolic syndrome (MS) using the modified National Cholesterol Education Program Adult Treatment Plan III (NCEP) and the International Diabetes Federation (IDF) definitions and, using both definitions, determine and compare the association of MS, prediabetes, type 2 diabetes, hypertension (HTN) and cardiovascular disease risk (CVD). Materials and Methods A total of 2,293 randomly selected participants (aged ≥20 years) in a rural community in Bangladesh were investigated in a population-based cross-sectional study. Sociodemographic and anthropometric characteristics, blood pressure, blood glucose, and lipid profiles were studied. Age-adjusted data for MS and cardiometabolic risk factors were assessed, and their relationships were examined. Results The age-adjusted prevalence of MS was 30.7% (males 30.5%; females 30.5%) using the NCEP definition, and 24.5% (males 19.2%, females 27.5%) using the IDF definition. The prevalence of MS using the NCEP definition was also higher in study participants with prediabetes, type 2 diabetes, HTN and CVD risk. The agreement rate between both definitions was 92% (k = 0.80). The NCEP definition had a stronger association with type 2 diabetes and HTN (odds ratio 12.4 vs 5.2; odds ratio 7.0 vs 4.7, respectively) than the IDF definition. However, the odds ratios for prediabetes and CVD risk were not significantly different. Conclusions The prevalence of MS was higher using the NCEP definition, and was more strongly associated with prediabetes, type 2 diabetes, HTN and CVD in this Bangladeshi population. PMID:25969712

  20. The reliability of the National Cholesterol Education Program's Adult Treatment Panel III (NCEP/ATP III) and the International Diabetes Federation (IDF) definitions in diagnosing metabolic syndrome (MetS) among Gaza Strip Palestinians.

    Science.gov (United States)

    Sirdah, Mahmoud M; Abu Ghali, Asmaa S; Al Laham, Nahed A

    2012-01-01

    Metabolic syndrome (MetS) which is a multifaceted syndrome, has been demonstrated as a common precursor for developing cardiovascular diseases and/or type 2 diabetes mellitus. Different diagnostic definitions for MetS have been proposed and recommended. We set up to evaluate the reliabilities of the National Cholesterol Education Program's Adult Treatment Panel III (NCEP/ATP III) and the International Diabetes Federation (IDF) definitions in diagnosing MetS among Gaza Strip Palestinians. This cross sectional study involved a randomly selected two hundred and thirty apparently healthy adults from the Gaza Strip. Anthropometric measurements, blood pressure, fasting plasma glucose, lipid profile, and questionnaire interviews were performed. The overall prevalence of MetS in our Gaza Strip cohort was 23.0% and 39.5% according to NCEP/ATP III and IDF definitions respectively (pdefinition (mean 3.42 ± 0.63 vs 3.52 ± 0.69 respectively, p=0.865). Both IDF and NCEP/ATP III showed an increased prevalence of MetS with age, and body mass index (BMI), however they revealed different prevalence trends with sex. Except for BMI, there were no significant differences in the general and metabolic related characteristics between subjects with MetS of IDF and NCEP/ATP III definitions. Independently of the definition used, MetS is highly prevalent in Gaza Strip population, with a steady increase in MetS prevalence through age and BMI. The IDF definition tends to give higher values for MetS prevalence, and therefore could be more appropriate for diagnosing MetS in Gaza Strip cohort. Copyright © 2012 Diabetes India. Published by Elsevier Ltd. All rights reserved.

  1. Comparison of the prevalence of metabolic syndrome and its association with diabetes and cardiovascular disease in the rural population of Bangladesh using the modified National Cholesterol Education Program Expert Panel Adult Treatment Panel III and International Diabetes Federation definitions.

    Science.gov (United States)

    Bhowmik, Bishwajit; Afsana, Faria; Siddiquee, Tasnima; Munir, Sanjida B; Sheikh, Fareeha; Wright, Erica; Bhuiyan, Farjana R; Ashrafuzzaman, Sheikh Mohammad; Mahtab, Hajera; Azad Khan, Abul Kalam; Hussain, Akhtar

    2015-05-01

    To compare the prevalence of metabolic syndrome (MS) using the modified National Cholesterol Education Program Adult Treatment Plan III (NCEP) and the International Diabetes Federation (IDF) definitions and, using both definitions, determine and compare the association of MS, prediabetes, type 2 diabetes, hypertension (HTN) and cardiovascular disease risk (CVD). A total of 2,293 randomly selected participants (aged ≥20 years) in a rural community in Bangladesh were investigated in a population-based cross-sectional study. Sociodemographic and anthropometric characteristics, blood pressure, blood glucose, and lipid profiles were studied. Age-adjusted data for MS and cardiometabolic risk factors were assessed, and their relationships were examined. The age-adjusted prevalence of MS was 30.7% (males 30.5%; females 30.5%) using the NCEP definition, and 24.5% (males 19.2%, females 27.5%) using the IDF definition. The prevalence of MS using the NCEP definition was also higher in study participants with prediabetes, type 2 diabetes, HTN and CVD risk. The agreement rate between both definitions was 92% (k = 0.80). The NCEP definition had a stronger association with type 2 diabetes and HTN (odds ratio 12.4 vs 5.2; odds ratio 7.0 vs 4.7, respectively) than the IDF definition. However, the odds ratios for prediabetes and CVD risk were not significantly different. The prevalence of MS was higher using the NCEP definition, and was more strongly associated with prediabetes, type 2 diabetes, HTN and CVD in this Bangladeshi population.

  2. The usefulness of the International Diabetes Federation and the National Cholesterol Education Program's Adult Treatment Panel III definitions of the metabolic syndrome in predicting coronary heart disease in subjects with type 2 diabetes.

    Science.gov (United States)

    Tong, Peter C; Kong, Alice P; So, Wing-Yee; Yang, Xilin; Ho, Chung-Shun; Ma, Ronald C; Ozaki, Risa; Chow, Chun-Chung; Lam, Christopher W; Chan, Juliana C N; Cockram, Clive S

    2007-05-01

    The purpose of this study was to compare the predictive value for coronary heart disease (CHD) of the International Diabetes Federation (IDF) definition (with Asian criteria for central obesity) of the metabolic syndrome with existing criteria of the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) in Chinese subjects with type 2 diabetes. Subjects with type 2 diabetes and without macrovascular diseases or end-stage renal disease were categorized by the criteria of the IDF and the NCEP ATP III. CHD was defined as myocardial infarction, ischemic heart disease, coronary revascularization, heart failure, and death related to CHD. Of 4,350 patients (aged 54.4 +/- 13.4 years; median follow-up period 7.1 [interquartile range 5.2-8.5] years), 65.9% had metabolic syndrome according to either IDF or NCEP ATP III criteria. The NCEP ATP III definition identified metabolic syndrome in 786 subjects (18.1%) who did not fulfill the criteria of the IDF. HDL cholesterol and systolic blood pressure were predictors of CHD after adjustment for other confounding factors. Compared with subjects without metabolic syndrome, the IDF criteria failed to predict CHD (hazard ratio 1.13 [95% CI 0.86-1.48], P = 0.374). In contrast, the NCEP ATP III definition (2.51 [1.80-3.50], P definition of the metabolic syndrome failed to identify a subgroup of patients who had the highest risk for CHD. Practitioners must recognize the appropriate setting for its application.

  3. PHARMACEUTICAL PRODUCT AND PROCEDURE LEGAL PROTECTION – ANDEAN COMMUNITARIAN LAW, TRIPS AGREEMENT AND FREE TRADE AGREEMENTS COLOMBIA/US AND COLOMBIA/EU

    OpenAIRE

    Jiménez Valderrama, Fernando Augusto; Universidsd de la Sabana

    2012-01-01

    Patent protection law for pharmaceutical products and medicines must har- monize the interests of both pharmaceutical industry and public health. Any pharmaceutical product must fulfill the requirements established by law to be registered as a patent. In the Andean Community, communitarian law gives preference to local law even if it comes from national sources or international treaties. Free Trade Agreements between Colombia and the United States of America, or Colombia and the European Unio...

  4. 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

  5. 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

  6. 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...

  7. Photostability Issues in Pharmaceutical Dosage Forms and Photostabilization.

    Science.gov (United States)

    Janga, Karthik Yadav; King, Tamara; Ji, Nan; Sarabu, Sandeep; Shadambikar, Gauri; Sawant, Sagar; Xu, Pengchong; Repka, Michael A; Murthy, S Narasimha

    2018-01-01

    Photodegradation is one of the major pathways of the degradation of drugs. Some therapeutic agents and excipients are highly sensitive to light and undergo significant degradation, challenging the quality and the stability of the final product. The adequate knowledge of photodegradation mechanisms and kinetics of photosensitive therapeutic entities or excipients is a pivotal aspect in the product development phase. Hence, various pharmaceutical regulatory agencies, across the world, mandated the industries to assess the photodegradation of pharmaceutical products from manufacturing stage till storage, as per the guidelines given in the International Conference on Harmonization (ICH). Recently, numerous formulation and/or manufacturing strategies has been investigated for preventing the photodegradation and enhancing the photostability of photolabile components in the pharmaceutical dosage forms. The primary focus of this review is to discuss various photodegradation mechanisms, rate kinetics, and the factors that influence the rate of photodegradation. We also discuss light-induced degradation of photosensitive lipids and polymers. We conclude with a brief note on different approaches to improve the photostability of photosensitive products.

  8. Cooperation between developing countries and the pharmaceutical industry in the control of parasitic diseases: a proposal for a practical approach.

    Science.gov (United States)

    Van Belle, N

    1984-01-01

    In this paper a pragmatic approach to the cooperation between developing countries and the pharmaceutical industry is proposed. This approach is based upon a division of tasks between the partners involved, thus maximizing the output through optimal use of each partner's capabilities. In the model proposed here, the pharmaceutical industry remains responsible for continued therapeutic research and development. These efforts are rewarded by the industry's transfers of active ingredients to pharmaceutical production plants. Pharmaceutical production and packaging plants can be decentralized and located in developing countries. Local organized integrated health care programs are the clients of the regional pharmaceutical plants. These programs can be coordinated and sponsored by national and international agencies and organizations. It is suggested that the transactions, possibly with the exception of the delivery of the products to the patients, be concluded along principles of the market economy. Dirigism and bureaucracy must be avoided.

  9. 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...

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. Metrology in Pharmaceutical Industry - A Case Study

    Science.gov (United States)

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

    2016-07-01

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

  15. Quality Evaluation of Pharmaceutical Formulations Containing Hydrochlorothiazide

    Directory of Open Access Journals (Sweden)

    Marcelo Antonio de Oliveira

    2014-10-01

    Full Text Available Hydrochlorothiazide is a diuretic used to treat hypertension that belongs to class IV of the Biopharmaceutics Classification System. The drug was evaluated by quality control, thermal characterization tests, and pharmaceutical formulation compatibility studies. It was concluded that the generic drug, Lab 2, was not a pharmaceutical equivalent. The compounded drugs, Lab 5 and Lab 6, produced unsatisfactory but expected results, since there is no requirement for dissolution and dissolution profile testing for the commercialization of these products. In a compatibility study, lactose and mannitol were shown to be incompatible with HCTZ, which may explain the lack of equivalence of the generic pharmaceutical product, associated with other situations.

  16. 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)

  17. 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

  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. 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

  20. 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.

  1. [On the Chosen Pharmaceutical Association and "The Journal of the Chosen Pharmaceutical Association"].

    Science.gov (United States)

    Ushikubo, Hiroko; Chiba, Yoshihiko; Misawa, Miwa

    2008-01-01

    In the 20th century, the medical and pharmaceutical fields in Korea and Japan were markedly developed. There was a deep relationship between the two countries as Japan had annexed Korea from 1910 to 1945, until the end of World War II. The present study was performed to investigate the Chosen Pharmaceutical Association and "The Journal of the Chosen Pharmaceutical Association" to research part of the history of Korean pharmacology in those days. In 1914, the Chosen Pharmaceutical Association was established; Takasato Kojima was appointed as the first chairman. The first issue of "The Journal of the Chosen Pharmaceutical Association" was published in 1921 as the only chemical bulletin in Korea. The contents of the journals mainly consisted of academic papers, investigations on hygiene and health in Korea and management reports of the association. Concerning the academic papers, most of them were on studies of environmental health and medicinal plants in Korea. The Chosen Pharmaceutical Association was disbanded by 1945.

  2. An analysis of Australia's legal regime for imposing liability on manufacturers of pharmaceutical drugs.

    Science.gov (United States)

    Tsui, Mabel

    2014-03-01

    Following a trial in June 2009 where the Federal Court heard submissions regarding whether Merck Sharpe and Dohme Australia should be held liable for an increased risk of cardiovascular conditions noted in patients who had taken the anti-inflammatory drug Vioxx, a judgment was handed down against MSDA in March 2010. MSDA then appealed to the Full Federal Court, where it was successful. A subsequent special leave to appeal application to the High Court of Australia was rejected in May 2012. This article examines the themes raised in the trial judgment and the appropriateness of Australia's statutory consumer protection regime through the lens of pharmaceutical drug injuries and side effects.

  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. 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...

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. [The history of modern Korean pharmaceutical education].

    Science.gov (United States)

    Ishida, Sumio

    2009-01-01

    During the Korean colonial days from 1910 to 1945, many Japanese pharmacists, druggists, apothecaries and pharmaceutical scientists worked in Korea. Although these fields belong to Japanese pharmaceutical history, there are very few papers about modern Korean pharmaceutical education written in Japanese. There is, however, a huge amount of general books written in Japanese which were published during Korean colonial days. These books are reprinted versions of originals, reprinted in Japan or Korea. It is possible to read these books at the Seoul National University Central Library, Medical Library, the History of Hospital Institute Library, the Central National Library in Seoul, the library in the Pusan Modern History Museum or the Pusan Municipal Library. While reading these books over four weeks in September 2008 in Seoul, information about modern Korean pharmaceutical education was obtained for this paper.

  10. 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.

  11. 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

  12. 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

  13. Pharmaceutical Distribution Market Channels in Poland

    OpenAIRE

    Agnieszka Woś

    2009-01-01

    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.

  14. Innovation strategies of Mexican pharmaceutical firms

    OpenAIRE

    José Luis Solleiro; Roberto E. López Martínez; Gabriela Sánchez; Yissel Inurrueta; Ana L. Sánchez; Antonia Terán; Jorge I. Castillo

    2010-01-01

    Mexican pharmaceutical market is the most important in Latin America and a significant number of global firms have different business activities in this country: production, licensing of patents, alliances with Mexican firms, distribution facilities or partnerships, etc. In terms of innovation, global pharmaceutical industry has passed through structural changes mainly of technological and institutional nature. These changes have been influential along the whole value chain and have triggered...

  15. INTRODUCING PATENT PROTECTION IN THE PHARMACEUTICAL SECTOR:

    OpenAIRE

    Maria Pluvia ZUNIGA; Emmanuel COMBE

    2002-01-01

    Reformed under NAFTA negotiations and in compliance with the TRIPs Agreement (Trade Related Intellectual Property Rights) when Mexico joined the World Trade Organization, patent protection for pharmaceuticals in this country has been reinforced since 1991 with the new Industrial Property Law. The aim of this paper is to make a first brief evaluation of the static and dynamic effects of the introduction of patent protection for pharmaceuticals in Mexico and to compare them to those predicted b...

  16. Pharmaceutical patent bargains: the Brazilian experience

    OpenAIRE

    Salama, Bruno Meyerhof; Benoliel, Daniel

    2010-01-01

    In the backdrop of the strict patent regime flatly adopted by the World Trade Organization (WTO) for all countries, a few countries constantly challenge this system through aggressive patent bargains. Within the pharmaceutical sector, noticeably, some countries now threaten to issue or otherwise actually issue compulsory licenses that may sway large pharmaceutical companies into selling drugs with large discounts or into granting voluntary licenses domestically. That is conspicuously the nego...

  17. Economic Drivers of Pharmaceutical Investment Location

    OpenAIRE

    David Lewis; Edward Bramley-Harker; Joshua Farahnik

    2007-01-01

    The article examines the range of economic factors that underlie decision making about the location of investments by research-based pharmaceutical companies. Set in the context of the commercial challenges facing the industry, structured interviews with 34 senior executives in pharmaceutical companies examined hypothetical investment scenarios. Unsurprisingly, both cost and quality factors are important to decision making, but their nature and relative importance depend heavily on the type o...

  18. Nanostructured materials in electroanalysis of pharmaceuticals.

    Science.gov (United States)

    Rahi, A; Karimian, K; Heli, H

    2016-03-15

    Basic strategies and recent developments for the enhancement of the sensory performance of nanostructures in the electroanalysis of pharmaceuticals are reviewed. A discussion of the properties of nanostructures and their application as modified electrodes for drug assays is presented. The electrocatalytic effect of nanostructured materials and their application in determining low levels of drugs in pharmaceutical forms and biofluids are discussed. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Raman spectroscopy in pharmaceutical product design

    DEFF Research Database (Denmark)

    Paudel, Amrit; Raijada, Dhara; Rantanen, Jukka

    2015-01-01

    molecular-based drug discovery, design of innovative drug delivery systems and quality control of finished products. This review presents concise accounts of various conventional and emerging Raman instrumentations including associated hyphenated tools of pharmaceutical interest. Moreover, relevant...... application cases of Raman spectroscopy in early and late phase pharmaceutical development, process analysis and micro-structural analysis of drug delivery systems are introduced. Finally, potential areas of future advancement and application of Raman spectroscopic techniques are discussed....

  20. 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

  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. 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.

  3. 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...

  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 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....

  6. 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...

  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. 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

  9. 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.

  10. 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...

  11. Engagement of the private pharmaceutical sector for TB control: rhetoric or reality?

    Science.gov (United States)

    Konduri, Niranjan; Delmotte, Emily; Rutta, Edmund

    2017-01-01

    Private-sector retail drug outlets are often the first point of contact for common health ailments, including tuberculosis (TB). Systematic reviews on public-private mix (PPM) interventions for TB did not perform in-depth reviews specifically on engaging retail drug outlets and related stakeholders in the pharmaceutical sector. Our objective was to better understand the extent to which the World Health Organization's (WHO) recommendation on engaging retail drug outlets has been translated into programmatic policy, strategy, and intervention in low- and middle-income countries. The study included a content analysis of global-level documents from WHO and the Stop TB Partnership in five phases. A country-level content analysis from four data sources was performed. Global-level findings were tabulated based on key messages related to engaging retail drug outlets. Country-level findings were analyzed based on four factors and tabulated. National strategic plans for TB control from 14 countries with varying TB burdens and a strong private sector were reviewed. 33 global-level documents and 77 full-text articles and Union World Lung Health conference abstracts were included for review. Based on experience of engaging retail drug outlets that has emerged since the mid-2000s, in 2011 WHO and the International Pharmaceutical Federation released a joint statement on promoting the engagement of national pharmacy associations in partnership with national TB programs. Only two of 14 countries' national strategic plans had explicit statements on the need to engage their national pharmacy professional association. The success rate of referrals from retail drug outlets who visited an approved health facility for TB screening ranged from 48% in Vietnam to 86% in Myanmar. Coverage of retail drug outlets ranged from less than 5 to 9% of the universe of retail drug outlets. For WHO's End TB Strategy to be successful, scaling up retail drug outlets to increase national coverage, at

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

    OpenAIRE

    Dipak Dilip Gadade; Sanjay Sudhakar Pekamwar

    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. 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

  14. Pharmaceutical policies in a crisis? Challenges and solutions identified at the PPRI Conference.

    Science.gov (United States)

    Vogler, Sabine; Zimmermann, Nina; Ferrario, Alessandra; Wirtz, Veronika J; de Joncheere, Kees; Pedersen, Hanne Bak; Dedet, Guillaume; Paris, Valérie; Mantel-Teeuwisse, Aukje K; Babar, Zaheer-Ud-Din

    2016-01-01

    In October 2015, the third international Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference was held in Vienna to foster discussion on challenges in pricing and reimbursement policies for medicines. The research presented highlighted that commonly used pharmaceutical pricing and reimbursement policies are not sufficiently effective to address current challenges. Conference participants called for fundamental reforms to ensure access to medicines, particularly to new and potentially more effective and/or safe medicines, while safeguarding the financial sustainability of health systems and working towards universal health coverage.

  15. Building a world class, globally competitive pharmaceutical business out of South Africa

    CSIR Research Space (South Africa)

    Nicolaou, Stavros

    2017-10-01

    Full Text Available to an international pharmaceutical manufacturer with the developed capability to supply various dosage forms to any pharmaceutical market in the world • In the last 10 years, billions have been invested in the Group’s South African facilities for infrastructural... & Canada 1 043 662 58% 618 69% Total 41 213 35 559 16% 33 751 22% Group revenue | by customer geography 7  Performance in ZAR is determined by − Fluctuations in exchange rate; and − Underlying operational performance  Exchange rate effect...

  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. AN INFORMATIC APPROACH TO ESTIMATING ECOLOGICAL RISKS POSED BY PHARMACEUTICAL USE: HUMAN PRESCRIPTION PHARMACEUTICALS

    Science.gov (United States)

    Pharmaceuticals are often excreted from patients as the parent compound or as active metabolites. Some of these compounds have been found in the environment. However, the environmental concentrations of the majority of pharmaceuticals and their metabolites are not known. The re...

  18. Energy transition in federalism

    International Nuclear Information System (INIS)

    Mueller, Thorsten; Kahl, Hartmut

    2015-01-01

    The conference transcript assemble the presentations of the 10th Wuerzburg discussions for environmental energy law. The contributions discuss the political development objectives of the Federal Government and Federal States as well as the coordination tasks between the different political levels, inter alia, of constitutional and European law perspective. [de

  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. [French language pharmaceutical publications in 1995. I. Assessment and analysis of French language pharmaceutical periodicals].

    Science.gov (United States)

    Bador, P; Grand, C; Locher, F

    1996-01-01

    Periodicals constitute a vital source of information and an invaluable continuing education medium to pharmacists. The aim of the present study was to compile the list of the 83 pharmacy-related periodicals published in French as at 1995 with a view to establishing their main characteristics. The first part focuses on the definition of the concept of "French language pharmaceutical periodicals" selected for the survey needed a) to be in circulation in 1995 and published at least two times a year, b) published by pharmacists or non-pharmacists but must carry articles intended to help, inform, or retrain pharmacists irrespective of their specialties (community, hospital, biological or industrial pharmacy) as well as their closest collaborators (assistants, technicians, etc.) and c) published in French. The second section presents the methodology of the survey, which consisted essentially in consulting publisher and library catalogs and direct interviews with embassies and Pharmacy Associations in French-speaking countries. Questionnaires were also sent out to editors of periodicals and the information gathered was analysed by computer. The following section reproduces the results of the the survey: These were classified into three categories: scientific, professional, and continuing education periodicals. The last section concentrates on their readership (national, international), frequency, modalities of publication, date of creation, indexing in bibliographic databases.

  1. 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.

  2. 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

  3. 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…

  4. 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

  5. [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

  6. Lubricants in Pharmaceutical Solid Dosage Forms

    Directory of Open Access Journals (Sweden)

    Jinjiang Li

    2014-02-01

    Full Text Available Lubrication plays a key role in successful manufacturing of pharmaceutical solid dosage forms; lubricants are essential ingredients in robust formulations to achieve this. Although many failures in pharmaceutical manufacturing operations are caused by issues related to lubrication, in general, lubricants do not gain adequate attention in the development of pharmaceutical formulations. In this paper, the fundamental background on lubrication is introduced, in which the relationships between lubrication and friction/adhesion forces are discussed. Then, the application of lubrication in the development of pharmaceutical products and manufacturing processes is discussed with an emphasis on magnesium stearate. In particular, the effect of its hydration state (anhydrate, monohydrate, dihydrate, and trihydrate and its powder characteristics on lubrication efficiency, as well as product and process performance is summarized. In addition, the impact of lubrication on the dynamics of compaction/compression processes and on the mechanical properties of compacts/tablets is presented. Furthermore, the online monitoring of magnesium stearate in a blending process is briefly mentioned. Finally, the chemical compatibility of active pharmaceutical ingredient (API with magnesium stearate and its reactive impurities is reviewed with examples from the literature illustrating the various reaction mechanisms involved.

  7. Occurence of pharmaceuticals in surface water

    Directory of Open Access Journals (Sweden)

    Dajana Gašo-Sokač

    2017-01-01

    Full Text Available Pharmaceuticals constitute a large group of human and veterinary medicinal organic compounds which have long been used throughout the world. According to their therapeutic activity they are classified in several groups: antibiotics, analgesics/antipyretic, CNS (Central nervous system drugs, cardiovascular drugs, endocrinology treatments, diagnostic aid-adsorbable organic halogen compounds. Pharmaceuticals are designed to have a physiological effect on humans and animals in trace concentrations. Pharmaceuticals end up in soil, surface waters and eventually in ground water, which can be used as a source of drinking water, after their excretion (in unmetabolized form or as active metabolites from humans or animals via urine or faeces. The possible fates of pharmaceuticals once they get into the aquatic environment are mainly three: (i ultimately they are mineralized to carbon dioxide and water, (ii the compound does not degrade readily because it is lipophilic and is partially retained in the sedimentation sludge and (iii the compound metabolizes to a more hydrophilic molecule, passes through the wastewater treatment plant and ends up in receiving waters (which are surface waters, mainly rivers. These compounds exhibit the highest persistence in the environment. In recent years, and in particular after the use of the advanced measurement technologies, many pharmaceuticals have been identified worldwide and detected at ng/L levels (trace concentrations in the aquatic environment, and are considered as an emerging environmental problem due to their continuous input and persistence in the aquatic ecosystem even at low concentrations.

  8. 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.

  9. 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.

  10. 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.

  11. Impact of pharmaceutical care on quality of life in patients with type 2 diabetes mellitus.

    Science.gov (United States)

    Sriram, Shanmugam; Chack, Lini Elizabeth; Ramasamy, Rajeswari; Ghasemi, Ali; Ravi, Thengungal Kochupapy; Sabzghabaee, Ali Mohammad

    2011-03-01

    Diabetes mellitus has become an international healthcare crisis that requires new approaches to prevent and treat it. The objective of this study was to evaluate the impact of pharmaceutical care on quality of life (QOL) in patients with type 2 diabetes mellitus. A prospective study on impact of pharmaceutical care on QOL in patients with type 2 diabetes mellitus was conducted in a private tertiary care teaching hospital in South India for a period of 8 months. Study was done on 120 eligible patients with type 2 diabetes mellitus enrolled randomly in the intervention group (with pharmaceutical care teachings) or the control (without drug related educations). The intervention group patients received pharmaceutical care through diabetes education, medication counseling, instructions on lifestyle that needed modifications (necessary for better drug function) and dietary regulations regarding their prescribed drugs, whereas the control group patients were deprived of any pharmaceutical care till the end of the study. The "Audit of Diabetes Dependent Quality of Life" standard questionnaire was used to assess the relevant parameters (including: Fasting Blood Glucose, HbA1c, Body Mass Index) and to evaluate the impact of the pharmaceutical care on the subjects. Data were analyzed using t-student test. The intervention group showed an improvement in the quality of life score from -2.156 ± 0.12 at the baseline to -1.41 ± 0.13 at the final interview (p diabetes treatment satisfaction score also changed in a similar pattern. The pharmaceutical care program was effective in improving the clinical outcome and the patients' QOL with type 2 diabetes mellitus.

  12. 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

  13. 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...

  14. 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.

  15. 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.

  16. 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.

  17. The men behind the eponymous pharmaceuticals companies

    Directory of Open Access Journals (Sweden)

    Khalid Al Aboud

    2014-01-01

    Full Text Available There are different sources of names in medical field. Similarly, the names given to pharmaceuticals companies are derived from different things. Selecting a good name is not always easy. In fact, there are now professional companies to help finding proper names for medical organizations and medications [1]. These were of help in naming pharmaceutical companies. For instance; ”Zeneca” was an invented name created by the branding consultancy Interbrand. Interbrand had been instructed to find a name which began with a letter from either the top or bottom of the alphabet and was phonetically memorable, of no more than three syllables and did not have an offensive meaning in any language. However, using the names of the founders (eponyms is a common type of naming pharmaceuticals companies.

  18. 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.

  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. Stability of Formulations Contained in the Pharmaceutical Payload Aboard Space Missions

    Science.gov (United States)

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

    2008-01-01

    Efficacious pharmaceuticals with adequate shelf life are essential for successful space medical operations in support of space exploration missions. Physical and environmental factors unique to space missions such as vibration, G forces and ionizing radiation may adversely affect stability of pharmaceuticals intended for standard care of astronauts aboard space missions. Stable pharmaceuticals, therefore, are of paramount importance for assuring health and wellness of astronauts in space. Preliminary examination of stability of formulations from Shuttle and International Space Station (ISS) medical kits revealed that some of these medications showed physical and chemical degradation after flight raising concern of reduced therapeutic effectiveness with these medications in space. A research payload experiment was conducted with a select set of formulations stowed aboard a shuttle flight and on ISS. The payload consisted of four identical pharmaceutical kits containing 31 medications in different dosage forms that were transported to the International Space Station (ISS) aboard the Space Shuttle, STS 121. One of the four kits was stored on the shuttle and the other three were stored on the ISS for return to Earth at six months intervals on a pre-designated Shuttle flight for each kit; the shuttle kit was returned to Earth on the same flight. Standard stability indicating physical and chemical parameters were measured for all pharmaceuticals returned from the shuttle and from the first ISS increment payload along with ground-based matching controls. Results were compared between shuttle, ISS and ground controls. Evaluation of data from the three paradigms indicates that some of the formulations exhibited significant degradation in space compared to respective ground controls; a few formulations were unstable both on the ground and in space. An increase in the number of pharmaceuticals from ISS failing USP standards was noticed compared to those from the shuttle

  1. 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.)

  2. 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) (pjournals, 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. FEDERAL BALANCING IN NIGERIA: A PARADIGM FOR ...

    African Journals Online (AJOL)

    user

    In Nigeria presently, the crisis of federalism has gone beyond the case of bickering among ethnic groups .... Internal affairs, Finance and Health are considered very important. So these juicy portfolios need to be fairly ..... President Shehu Shagari in 1980 but it submitted its report in 1981. It was headed by Dr. Pius Okigbo, ...

  4. 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

  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)

    2015-01-01

    Background 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. Methods 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. Results 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. Conclusions The results suggest that an active learning course can enhance the learning of pharmaceutical care competences. In

  7. 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

  8. 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...

  9. 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...

  10. 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...

  11. 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)

  12. REGULATORY CHALLENGES IN GLOBAL PHARMACEUTICAL MARKET

    OpenAIRE

    Vibhu Yadav et al.

    2012-01-01

    The global pharmaceutical industry “looks like the epitome of a modern, mature industry that has found a comfortable way to make profits by the billion: it’s global, hi-tech, and has the ultimate customer, the health care budget of the world’s richest countries. A number of factors contributed to the globalization of the pharmaceutical industry. Chief among these are the convergence of medical science and practice under the influence of modern communication technology and increased and inform...

  13. International Journal of Health Research

    African Journals Online (AJOL)

    Erah

    collaboration among scientists, the industry and the healthcare professionals. It will also provide an international forum for the ... private hospitals (35.2%) followed by pharmaceutical store. (27.9%) and 17.0% for general/teaching ..... convenience and proximity (71.6%), privacy. (58.7%), respect or good attitude by workers.

  14. Sulfite-containing Canadian pharmaceutical products available in 1991.

    Science.gov (United States)

    Miyata, M; Schuster, B; Schellenberg, R

    1992-01-01

    OBJECTIVE: To compile an inclusive list of Canadian pharmaceutical products available in 1991 that contained sulfites. DATA SOURCES: Written and oral responses from 94 pharmaceutical companies selected from the 1989 Compendium of Pharmaceuticals and Specialties. RESULTS: A list of sulfite-containing pharmaceutical products was compiled from data supplied by the 90 responding companies. Companies whose products contained no sulfites were separately identified. CONCLUSIONS: Sulfites are present in many pharmaceutical products and are one of many excipients and additives that have been reported to cause severe adverse reactions. The provided list should be a useful aid for health care practitioners when prescribing pharmaceutical products for sulfite-sensitive patients. PMID:1483237

  15. 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)

    2000-01-01

    The document reproduces the text of the Exchange of Letters concerning an agreement with the Federative Republic of Brazil in connection with the Treaty on the Non-Proliferation of Nuclear Weapons and 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 20 September 1999, and entered into force on that date

  16. The reasons behind medicine shortages from the perspective of pharmaceutical companies and pharmaceutical wholesalers in Finland.

    Science.gov (United States)

    Heiskanen, Kati; Ahonen, Riitta; Kanerva, Risto; Karttunen, Pekka; Timonen, Johanna

    2017-01-01

    The aim of this study was to explore the reasons behind medicine shortages from the perspective of pharmaceutical companies and pharmaceutical wholesalers in Finland. The study took the form of semi-structured interviews. Forty-one pharmaceutical companies and pharmaceutical wholesalers were invited to participate in the study. The pharmaceutical companies were the member organizations of Pharma Industry Finland (PIF) (N = 30) and the Finnish Generic Pharmaceutical Association (FGPA) (N = 7). One company which is a central player in the pharmaceutical market in Finland but does not belong to PIF or FGPA was also invited. The pharmaceutical wholesalers were those with a nationwide distribution network (N = 3). A total of 30 interviews were conducted between March and June 2016. The data were subjected to qualitative thematic analysis. The most common reasons behind medicine shortages in Finland were the small size of the pharmaceutical market (29/30), sudden or fluctuating demand (28/30), small stock sizes (25/30), long delivery time (23/30) and a long or complex production chain (23/30). The reasons for the medicine shortages were supply-related more often than demand-related. However, the reasons were often complex and there was more than one reason behind a shortage. Supply-related reasons behind shortages commonly interfaced with the country-specific characteristics of Finland, whereas demand-related reasons were commonly associated with the predictability and attractiveness of the market. Some reasons, such as raw material shortages, were considered global and thus had similar effects on other countries.

  17. The reasons behind medicine shortages from the perspective of pharmaceutical companies and pharmaceutical wholesalers in Finland.

    Directory of Open Access Journals (Sweden)

    Kati Heiskanen

    Full Text Available The aim of this study was to explore the reasons behind medicine shortages from the perspective of pharmaceutical companies and pharmaceutical wholesalers in Finland. The study took the form of semi-structured interviews. Forty-one pharmaceutical companies and pharmaceutical wholesalers were invited to participate in the study. The pharmaceutical companies were the member organizations of Pharma Industry Finland (PIF (N = 30 and the Finnish Generic Pharmaceutical Association (FGPA (N = 7. One company which is a central player in the pharmaceutical market in Finland but does not belong to PIF or FGPA was also invited. The pharmaceutical wholesalers were those with a nationwide distribution network (N = 3. A total of 30 interviews were conducted between March and June 2016. The data were subjected to qualitative thematic analysis. The most common reasons behind medicine shortages in Finland were the small size of the pharmaceutical market (29/30, sudden or fluctuating demand (28/30, small stock sizes (25/30, long delivery time (23/30 and a long or complex production chain (23/30. The reasons for the medicine shortages were supply-related more often than demand-related. However, the reasons were often complex and there was more than one reason behind a shortage. Supply-related reasons behind shortages commonly interfaced with the country-specific characteristics of Finland, whereas demand-related reasons were commonly associated with the predictability and attractiveness of the market. Some reasons, such as raw material shortages, were considered global and thus had similar effects on other countries.

  18. ACA Federal Upper Limits

    Data.gov (United States)

    U.S. Department of Health & Human Services — Affordable Care Act Federal Upper Limits (FUL) based on the weighted average of the most recently reported monthly average manufacturer price (AMP) for...

  19. New Mexico Federal Lands

    Data.gov (United States)

    Earth Data Analysis Center, University of New Mexico — This map layer consists of federally owned or administered lands of the United States, Puerto Rico, and the U.S. Virgin Islands. Only areas of 640 acres or more are...

  20. Federal Ballpark Estimator

    Data.gov (United States)

    Office of Personnel Management — The Federal Ballpark E$timate(R) was developed by the Employee Benefit Research Institute(R) and its American Savings Education Council(R) (ASEC(R)) program. It is...