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Sample records for pharmaceutical sector perceptions

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

    PubMed Central

    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

  2. Pharmaceutical and Medicine Manufacturing Sector (NAICS 3254)

    EPA Pesticide Factsheets

    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.

  3. The pharmaceutical sector inquiry: 'Hamlet' in a nutshell.

    PubMed

    den Exter, André

    2010-03-01

    In July 2009, the European Commission (DG Competition) published a Communication on the pharmaceutical sector. This inquiry was launched because there were some indications that competition in the pharmaceutical market in the European Union might not be working well. The report examines the reasons for the observed delay. This article analyses the outcomes from a critical standpoint, arguing in favour of enhanced 'soft law' accountability mechanisms in the pharmaceutical sector, defending conditional patenting and the introduction of a Community patent.

  4. Corporate social responsibility in countries with mature and emerging pharmaceutical sectors

    PubMed Central

    Volodina, Anna; Sax, Sylvia; Anderson, Stuart

    2009-01-01

    In recent decades the concept of Corporate Social Responsibility (CSR) has been adopted by many business sectors, including the pharmaceutical industry. However, in this and other sectors its application remains variable, particularly between mature and developing economies. Its stakeholders include pharmacy and medical students, their attitude to the involvement of companies in socially responsible activities will be important determinants of public response to the industry. Objective: To investigate the knowledge, attitudes and practices of senior medical and pharmacy students towards the CSR concept in the pharmaceutical sector in mature (Germany) and developing (Russia) markets. Methods: A questionnaire survey was carried out among senior pharmacy and medical students during the summer semester 2008 in two Russian and one German university. In each country 120 questionnaires were distributed. The response rate was 95% in Russia and 93% in Germany. Results: Although the relevance of CSR was widely acknowledged by the students, very few were aware of CSR practices currently performed by companies. The reputation of the pharmaceutical industry was generally poor: less than 15% of respondents gave credence to the information provided in advertisements and fully supported pricing strategies as well as policies towards the developing countries. When choosing an employer more than 90% of respondents consider the policies affecting an employee directly as pivotal. However, for a high proportion of students (59% in Russia and 64% in Germany) socially irresponsible behavior by companies has a significant negative impact. Conclusions: This paper identifies practices which students believe should be a part of the CSR programmes for the pharmaceutical industry, and also some that should be abandoned. It recommends that corporate communication on CSR should be expanded. Key differences are seen in perceptions of students in Germany and Russia towards the extent of

  5. The Pharmaceutical Sector of Kazakhstan's Economy: Trends and Problems

    ERIC Educational Resources Information Center

    Nurpeisov, Borankul G.; Nabiev, Erboz N.; Mukashev, Temirbay A.; Daribekov, Serik S.; Raimbekov, Bagdat Kh.; Asanova, Maral K.; Bazarbaeva, Leila M.

    2016-01-01

    This research is devoted to the investigation of the general trends in the development of the pharmaceutical industry in the current conditions of economical socialization. The determination of the economic specificity of the modern operation of the pharmaceutical industry is the purpose of the research. It was found that pharmacy is a profitable…

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

    PubMed

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

    2012-03-01

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

  7. Public perceptions of health care professionals' participation in pharmaceutical marketing.

    PubMed

    Crigger, Nancy J; Courter, Laura; Hayes, Kristen; Shepherd, K

    2009-09-01

    Trust in the nurse-patient relationship is maintained not by how professionals perceive their actions but rather by how the public perceives them. However, little is known about the public's view of nurses and other health care professionals who participate in pharmaceutical marketing. Our study describes public perceptions of health care providers' role in pharmaceutical marketing and compares their responses with those of a random sample of licensed family nurse practitioners. The family nurse practitioners perceived their participation in marketing activities as significantly more ethically appropriate than did the public responders. Further research is warranted before conclusions can be drawn, but these early findings suggest that nurse practitioners should consider a conservative approach to participating in pharmaceutical marketing.

  8. Using interpersonal perception to characterize pharmacists' and patients' perceptions of the benefits of pharmaceutical care.

    PubMed

    Assa-Eley, Michelle; Kimberlin, Carole L

    2005-01-01

    Pharmacists and patients seem to have divergent beliefs about potential pharmacy services. Patients have reported desiring more from pharmacists, yet pharmacists have cited lack of patient demand as a reason for not providing pharmaceutical care. Pharmacists (N = 147) and patients (N = 151) completed a questionnaire from multiple perspectives using an interpersonal perception approach assessing their perceptions of the benefits of pharmaceutical care. Findings revealed that pharmacists and patients disagreed on the benefits of those services. Further, they misunderstood each other's perceptions of those services. Few significant differences were found between patients who reported receiving additional services from their pharmacist and those who did not. By directly addressing these differences, pharmacists can attempt to improve patients' perceptions of pharmacy services while providing valuable new services.

  9. Reconsidering Japan's underperformance in pharmaceuticals: evidence from Japan's anticancer drug sector.

    PubMed

    Umemura, Maki

    2010-01-01

    Unlike its automobile or electronics industries, Japan's pharmaceutical industry did not become a global leader. Japan remains a net importer of pharmaceuticals and has introduced few global blockbuster drugs. Alfred Chandler argued that Japan's pharmaceutical firms remained relatively weak because Western firms enjoyed an insurmountable first first-mover advantage. However, this case study of the anticancer drug sector illustrates that Chandler's explanation is incomplete. Japanese medical culture, government policy, and research environment also played a substantial role in shaping the industry. In the 1970s and 1980s, these factors encouraged firms to develop little few effective drugs with low side effects, and profit from Japan's domestic market. But, these drugs were unsuitable to foreign markets with more demanding efficacy standards. As a result, Japan not only lost more than a decade in developing ineffective drugs, but also neglected to create the infrastructure necessary to develop innovative drugs and build a stronger pharmaceutical industry.

  10. A fair day's wage? Perceptions of public sector pay.

    PubMed

    Furnham, Adrian; Stieger, Stefan; Haubner, Tanja; Voracek, Martin; Swami, Viren

    2009-12-01

    There is a scarcity of evidence pertaining to the general public's perception of public sector pay. Hence, in the present study, 161 women and 149 men were asked to estimate the wages 35 public sector professions should receive annually in the fictitious nation of Maldoria, based on a comparison value of an annual income of T10,000 for general practitioners. Analysis showed that only pilots were given a higher annual income than general practitioners; miners and local government workers were also provided with relatively high annual incomes. By contrast, newscasters were provided with the lowest annual income. Participants' sex did not affect these evaluations, and other demographic variables and public sector-related information of the participants were poor predictors of their evaluations. The implications of this research on public attitudes toward wage determination are discussed, and avenues for further research highlighted.

  11. Pharmaceutical sector in transition--a cross sectional study in Vietnam.

    PubMed

    Falkenberg, T; Nguyen, T B; Larsson, M; Nguyen, T D; Tomson, G

    2000-09-01

    Increasing efforts are being made to improve pharmaceutical sector performance in low- and middle-income countries. An essential tool for such work is an objective and standard method of assessment which can be used to promote evidenced based National Drug Policy development and implementation. The average drug expenditure per capita has steadily increased in Vietnam and at the time of this study a National Drug Policy was being developed. This study assessed the Vietnamese pharmaceutical sector 1991-1994, focusing on the standard of the drug quality control system, availability of drugs and rational use of essential drugs in the private and public sectors by means of standardised indicators. The results from this study show that the quality control system is impaired and does not have capacity to quality control all drugs on the market. The availability of essential drugs is good whereas essential drugs are poorly prescribed, injections common and there is a high average number of drugs per prescription, both in the public and private sectors. Violations are common and enforcement of regulations weak. On top of this there is an active commercial advertising and marketing of drugs. These findings identify priorities for action to improve the present situation where the development and implementation of the Vietnamese National Drug Policy will be of major importance.

  12. [Pharmaceutical procurement by the public sector: the quality/cost relationship].

    PubMed

    Luiza, V L; Castro, C G; Nunes, J M

    1999-01-01

    The authors discuss procurement and provision of pharmaceutical products from the perspective of supply management in the public health sector, focusing on two main aspects: quality and cost. The article analyzes issues to be considered by buyers when evaluating drug quality, especially formulation stability, bioequivalence, and the role of generics. Also discussed are factors involving costs and cost management in relation to technological innovations and consumer demands. New alternatives and suggestions are examined and presented for procurement of high-quality, cost-effective drug products.

  13. The politics of health sector reform in developing countries: three cases of pharmaceutical policy.

    PubMed

    Reich, M R

    1995-01-01

    This paper examines the political dynamics of health sector reform in poor countries, through a comparative study of pharmaceutical policy reform in Sri Lanka, Bangladesh, and the Philippines. The paper first reviews five reasons why policy reform is political. It then presents three political economic models of the policy reform process: the political will, political factions, and political survival models. Next, the paper describes the three cases of national pharmaceutical policy reform, and identifies common conditions that made these reforms politically feasible. The paper's analysis suggests that health sector reform is feasible at certain definable, and perhaps predictable, political moments, especially in the early periods of new regimes. The most important and manipulable political factors are: political timing, which provides opportunities for policy entrepreneurs to introduce their ideas into public debate, and political management of group competition, which allows leaders to control the political effects of distributional consequences and protect the regime's stability. A strong and narrow political coalition improves the capacity of political leaders to resist the pressures of concentrated economic costs (both inside and outside national boundaries). The paper argues that for reform to succeed, policy-makers need effective methods to analyze relevant political conditions and shape key political factors in favor of policy reform. The method of Political Mapping is briefly introduced as a technique that can help policy-makers in analyzing and managing the political dimensions of policy reform and in improving the political feasibility of reform.

  14. Pharmacists' perception of pharmaceutical care in community pharmacy: a questionnaire survey in Northwest China.

    PubMed

    Fang, Yu; Yang, Shimin; Feng, Bianling; Ni, Yufei; Zhang, Kanghuai

    2011-03-01

    The aim of this study was to explore the perceptions of community pharmacists towards the concept of pharmaceutical care, implementing frequencies of pharmaceutical care, and barriers to implementation of pharmaceutical care in China. A 38-item self-completion pre-tested questionnaire was administered to a quota sample of 130 pharmacists in community pharmacies in Xi'an, Shaanxi Province, northwest China in April 2008. Main outcome measures included understanding of pharmaceutical care; perceived frequency of pharmaceutical care activities; attitude towards pharmaceutical care; barriers to implementation of pharmaceutical care. A response rate of 77.7% (101/130) was achieved. The data were analysed descriptively. Factor analysis was used to explore potential barriers to the provision of pharmaceutical care. Respondents' understanding of the definition of pharmaceutical care was not entirely satisfactory: it was widely but incorrectly seen as a medication counselling service and many pharmacists appeared to misunderstand their role in the process. Respondents spent most of their work time performing prescription checks and providing patients with directions for drug administration, dosage, and precautions, but they tended to ignore health promotion within and outside of pharmacy settings. Factor analysis suggested four factors influencing the implementation of pharmaceutical care in the surveyed community pharmacies: lack of external conditions for developing or providing pharmaceutical care, lack of time and skills, absence of information and economic incentive, and lack of full support from other health professionals, with a cumulative variance of 64.7%. Cronbach's alpha for the four factors was 0.71, 0.72, 0.69 and 0.74, respectively. Although the respondent pharmacists had a certain degree of understanding of the definition, aim, function and use of pharmaceutical care, and carried out some activities currently, a range of barriers need to be overcome before

  15. Participants’ perception of pharmaceutical clinical research: a cross-sectional controlled study

    PubMed Central

    González-Saldivar, Gerardo; Rodríguez-Gutiérrez, René; Viramontes-Madrid, José Luis; Salcido-Montenegro, Alejandro; Carlos-Reyna, Kevin Erick Gabriel; Treviño-Alvarez, Andrés Marcelo; Álvarez-Villalobos, Neri Alejandro; González-González, José Gerardo

    2016-01-01

    Background There is scarce scientific information assessing participants’ perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials. Methods To assess the perception that 604 trial participants (cases) and 604 nonparticipants (controls) of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico. Results Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4%) than controls (50.7%) perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%). We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants’ health is put at risk (57% vs 33.3%). More cases (99.2%) than controls (77.5%) would recommend participating in a clinical trial, and 90% of cases would enroll in a clinical trial again. Conclusion Participation in clinical trials positively influences the perception that participants have about pharmaceutical clinical research when compared to nonparticipants. This information needs to be conveyed to clinicians, public health authorities, and general population to overcome misconceptions. PMID:27199549

  16. [Mechanism and implication of regulation of the pricing of essential medicines in the private pharmaceutical sector in Mali].

    PubMed

    Maïga, D; Maïga, S; Maïga, M D

    2010-04-01

    The healthcare and pharmaceutical professions in Mali were privatized in 1985. Privatization led to swift expansion of the private sector and upset the balance that had existed between the public and private sectors. A national pharmaceutical policy did not emerge until a decade later. Its purpose was to promote a system ensuring fair access to essential generic medicines for all. It was hoped that synergy between the two sectors would promote that objective. However, the policy calling for distribution of essential generic medicine through the private sector was not accompanied by an adequate system for pricing. This problem led the government to adopt a price regulation policy to realign market dynamics with public health goals. This experience shows that a sustained effort from public policy makers is necessary to prevail against the professional and business interests that can conflict with the public interest. Analysis of this experience also demonstrates the need to improve, restructure, and control the pharmaceutical industry. The government must continue to play its crucial role in the context of limited resources and inequality between consumers and pharmaceutical companies.

  17. The impact of the cox-2 inhibitor issue on perceptions of the pharmaceutical industry: content analysis and communication implications.

    PubMed

    Lofstedt, Ragnar E

    2007-01-01

    The field of risk communication has its roots in the environmental, chemical, space, and nuclear arenas. As a number of these sectors have now vastly improved their communication strategies, attention is being placed on sectors that have been more problematic as of late. Examples of such sectors, include the food industries and the pharmaceutical/health sector. This article focuses on how large, multinational pharmaceutical companies can better communicate risks by analysis of one specific case, namely, that of the Cox-2 controversy.(1) For purposes of this article, risk communication is best described as "the flow of information and risk evaluations back and forth between academic experts, regulatory practitioners, interest groups and the general public," and "big pharma" refers to the more traditional R & D-based, innovative pharmaceutical companies.

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

    NASA Astrophysics Data System (ADS)

    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. Organizational Perceptions of Telecommuting in the Private Sector

    ERIC Educational Resources Information Center

    Galusha, Repps J.

    2011-01-01

    The Internet has provided more organizations the opportunity to adopt telecommuting as a means to recruit and retain employees, boost productivity, and trim facility costs. This study expands on the work of a previous study by Hoang, Nickerson, Beckman, and Eng, in 2008 which found that private organizations, due to perceptions of organizational…

  20. Do perceptions of direct-to-consumer pharmaceutical advertising vary based on urban versus rural living?

    PubMed

    Spake, Deborah F; Joseph, Mathew; Megehee, Carol M

    2014-01-01

    This study explores the connection between perceptions of direct-to-consumer (DTC) advertising based on where people live and shop. Urban consumers were found to be more skeptical of DTC advertising, but more likely to believe that physicians select pharmaceuticals based on the efficacy of the product. Those living in rural areas were more motivated to visit a doctor and more likely to feel an equal doctor-patient relationship after exposure to DTC advertising. Interaction effects among gender, income, and education were detected, as well as an interaction effects between location and income on views of DTC advertising.

  1. Perceptions and Attitudes of Egyptian Health Professionals and Policy-Makers towards Pharmaceutical Sales Representatives and Other Promotional Activities

    PubMed Central

    Kamal, Susan; Holmberg, Christine; Russell, Jean; Bochenek, Tomasz; Tobiasz-Adamczyk, Beata; Fischer, Christiane; Tinnemann, Peter

    2015-01-01

    Background Pharmaceutical promotion activities in low and middle-income countries are often neither regulated nor monitored. While Egypt has the highest population and per capita use of medicines in the Arab world, we know very little about pharmaceutical companies promotional activities in the country. Aim To explore and analyze the perceptions of physicians towards promotional and marketing activities of pharmaceutical companies among physicians and pharmacists in Egypt. Methodology Perspectives of different healthcare system stakeholders were explored through semi-structured, in-depth interviews conducted in 2014 in Cairo, Egypt. Interviewees were chosen via purposive sampling and snowball technique. Each interview was recorded and transcribed. Then qualitative, thematic analysis was conducted with the help of NVIVO software. Findings The majority of physicians and pharmacists acknowledged exposure to pharmaceutical promotion. It was commonly believed that interaction with the pharmaceutical industry is necessary and both associated risks and benefits were acknowledged. The interviewed physicians considered themselves competent enough to minimize risks and maximize benefits to their prescribing habits. Views diverged on the extent and magnitude of the risks and benefits of pharmaceutical promotion, especially in regard to the influence on patients’ health. Conclusions Pharmaceutical promotion in Egypt is intensely directed at prescribers and dispensers. Physicians, pharmacists and policymakers expressed little skepticism to the influence of promotion towards their individual prescribing. Raising awareness of the pitfalls of pharmaceutical promotion is necessary, especially among the less experienced physicians. PMID:26473484

  2. The power of r - pharmaceutical sales decomposition in Cyprus public healthcare sector and determinants of drug expenditure evolution: any lessons learned?

    PubMed

    Petrou, Panagiotis

    2014-04-01

    The pharmaceutical sector has been established as the primary cost driver in health. The scope of this paper is to explore the drivers of pharmaceutical expenditure in Cyprus by decomposing sales and assessing impact of prices, volumes and substitution effect. We used a statistical approach to decompose the growth of public pharmaceutical expenditure during 2005-2011 into three elements: 1) substitution effect; 2) price effect; and 3) increase of consumption. We further decomposed consumption into: 1) prescription/visits; 2) visits/beneficiaries; and 3) beneficiaries. Pharmaceutical expenditure grew by 31.4 % and volume of medicines dispensed increased by 55%. Prices declined by 11% and product-mix residual was -5.5%, indicating that Cyprus experienced a switch to cheaper medicines (generics) without compromising access of patients to innovative medicines. This was enhanced by guidelines, monitoring of prescribing behavior, generic substitution and efficient tendering. The increasing number of products per prescriptions should be monitored with caution.

  3. Public perceptions of non-pharmaceutical interventions for reducing transmission of respiratory infection: systematic review and synthesis of qualitative studies

    PubMed Central

    2014-01-01

    Background Non-pharmaceutical public health interventions may provide simple, low-cost, effective ways of minimising the transmission and impact of acute respiratory infections in pandemic and non-pandemic contexts. Understanding what influences the uptake of non-pharmaceutical interventions such as hand and respiratory hygiene, mask wearing and social distancing could help to inform the development of effective public health advice messages. The aim of this synthesis was to explore public perceptions of non-pharmaceutical interventions that aim to reduce the transmission of acute respiratory infections. Methods Five online databases (MEDLINE, PsycINFO, CINAHL, EMBASE and Web of Science) were systematically searched. Reference lists of articles were also examined. We selected papers that used a qualitative research design to explore perceptions and beliefs about non-pharmaceutical interventions to reduce transmission of acute respiratory infections. We excluded papers that only explored how health professionals or children viewed non-pharmaceutical respiratory infection control. Three authors performed data extraction and assessment of study quality. Thematic analysis and components of meta-ethnography were adopted to synthesise findings. Results Seventeen articles from 16 studies in 9 countries were identified and reviewed. Seven key themes were identified: perceived benefits of non-pharmaceutical interventions, perceived disadvantages of non-pharmaceutical interventions, personal and cultural beliefs about infection transmission, diagnostic uncertainty in emerging respiratory infections, perceived vulnerability to infection, anxiety about emerging respiratory infections and communications about emerging respiratory infections. The synthesis showed that some aspects of non-pharmaceutical respiratory infection control (particularly hand and respiratory hygiene) were viewed as familiar and socially responsible actions to take. There was ambivalence about adopting

  4. Community awareness and perceptions of health sector preparedness and response to Cyclone Nargis.

    PubMed

    Myint, N W; Kaewkungwal, J; Singhasivanon, P; Chaisiri, K; Ponpet, P; Siriwan, P; Mallik, A K; Thet, K W

    2011-07-01

    Community awareness, preparedness and response to public health emergencies are essential for a successful response to public health emergencies. This study was carried out to determine community awareness and perceptions regarding health sector preparedness and response to Cyclone Nargis in Myanmar. Six focus group discussions were carried out in 3 villages severely affected by Cyclone Nargis. Thematic content analysis was carried out to determine community perceptions. Focus group participants, consisting of community members, community leaders and government personnel, were aware of the cyclone, but were unaware of its intensity and where it would make landfall. There was inadequate knowledge on how to prepare for a cyclone. There was some training on cyclone preparation but coverage was not wide enough. Participants received service and relief from health sector; they had a positive attitude toward health services provided to them. However, 5 out of 6 focus groups stated most villagers were not interested in health education. Only a few participants had some knowledge on how to prepare for a cyclone. Based on these results, there are evident weaknesses on how to prepare for cyclones. Community preparedness is essential to prevent disasters with cyclones, such as with Cyclone Nargis.

  5. Conceptualizations of water security in the agricultural sector: Perceptions, practices, and paradigms

    NASA Astrophysics Data System (ADS)

    Malekian, Atefe; Hayati, Dariush; Aarts, Noelle

    2017-01-01

    Conceptions of agricultural water security are conditioned by larger understandings of being and reality. It is still unclear what such understandings mean for perspectives on water security in general and on causes and solutions related to perceived water security risks and problems in agricultural sector in particular. Based on a systematic literature review, three conceptualizations of water security, related to different paradigms, are presented. Also the consequences of such conceptualizations for determining research objectives, research activities, and research outcomes on agricultural water security are discussed. The results showed that agricultural water security from a positivist paradigm referred to tangible and measurable water-related hazards and threats, such as floods and droughts, pollution, and so forth. A constructivist approach to agricultural water security, constituted by a process of interaction and negotiation, pointed at perceptions of water security of farmers and other stakeholders involved in agricultural sector. A critical approach to agricultural water security focused on the processes of securing vulnerable farmers and others from wider political, social, and natural impediments to sufficient water supplies. The conclusions of the study suggest that paradigms, underlying approaches should be expressed, clarified, and related to one another in order to find optimal and complementary ways to study water security issues in agricultural sector.

  6. Case studies on heat stress related perceptions in different industrial sectors in southern India

    PubMed Central

    Balakrishnan, Kalpana; Ramalingam, Ayyappan; Dasu, Venkatesan; Stephen, Jeremiah Chinnadurai; Sivaperumal, Mohan Raj; Kumarasamy, Deepan; Mukhopadhyay, Krishnendu; Ghosh, Santu; Sambandam, Sankar

    2010-01-01

    Linkages between thermal loads and its physiological consequences have been widely studied in non-tropical developed country settings. In many developing countries like India, despite the widespread recognition of the problem, limited attempts have been made to estimate health impacts related to occupational heat stress and fewer yet to link heat stress with potential productivity losses. This is reflected in the ubiquity of workplaces with limited or no controls to reduce exposures. As a prelude to understanding the feasibility of alternative interventions in different industrial sectors, we present case studies from 10 different industrial units in Tamil Nadu, Chennai, which describe perceptions of occupational heat stress among the workers and supervisors/management. Units were selected from among those who had previously requested an assessment of workplace heat stress exposure at select locations as part of routine industrial hygiene services provided by the investigators. Since the earlier measurements were performed in response to a management request, all units were revisited to generate a simple job and process profile using checklists in order to understand the overall heat exposure situation in the concerned unit. This was followed by a simple questionnaire administration to a small subsample of employees to evaluate the perceptions of workers and supervisors/management. Finally, we retrieved available quantitative data from previous measurements of heat stress at these units to correlate prevalence of exposures with respective perceptions. Results indicate that the existing level of controls may not be sufficient for managing work-related heat stress in any of the sectors studied, with wide variations in perceived risks. There was a noticeable disconnect between worker's perceptions and their ability to secure workplace improvements related to heat stress from the management. Wider availability of engineering and administrative controls in the

  7. Squaring Their Roots: Leadership Perceptions and Practices of Some U.S.-Trained African Professionals in the Public Sector

    ERIC Educational Resources Information Center

    Dant, William Patrick

    2010-01-01

    This qualitative study looks at the leadership perceptions and practices of career professionals in the public sector across three countries of sub-Saharan Africa (Ethiopia, Ghana and Madagascar). All participants were alumni of the Humphrey Fellowship program, a year-long mid-career fellowship in the United States for professional development and…

  8. The Impact of Sexuality in Contemporary Culture: An Interpretive Study of Perceptions and Choices in Private Sector Dance Education

    ERIC Educational Resources Information Center

    Risner, Doug; Godfrey, Heidi; Simmons, Linda C.

    2004-01-01

    The ways in which seven private sector dance professionals in the United States perceive the impact of sexuality in contemporary culture and the choices that they make for their own schools of dance because of these perceptions are explored. This study was conducted through in-depth interviews and a survey instrument. The participants' narratives…

  9. Perceptions and factors affecting pharmaceutical market access: results from a literature review and survey of stakeholders in different settings

    PubMed Central

    Sendyona, Semukaya; Odeyemi, Isaac; Maman, Khaled

    2016-01-01

    Background A change in the pharmaceutical environment has occurred from previously only needing to convince regulators of a product's safety and efficacy to obtain marketing authorisation to now needing to satisfy the value perceptions of other stakeholders, including payers, to attain market access for products. There is thus the need to understand the concept of market access that may be defined as ‘the process that ensures the development and commercial availability of pharmaceutical products with appropriate value propositions, leading to their prescribing and to successful uptake decisions by payers and patients, with the ultimate goal of achieving profitability and best patient outcomes’. The aim of this research therefore was to explore the understanding of market access among various stakeholders and how their understanding of this concept could improve patient access to pharmaceutical products. Methods A literature review was conducted on MEDLINE by using the term ‘market access’ to find articles with explicit definitions of market access for pharmaceutical products; non-peer–reviewed and other grey literature sources were also examined. A paper-based interview survey was also conducted in three different settings. The respondents were asked about what factors they think contribute to the successful development of pharmaceutical products, as well as their definition of market access for these medicines. Results The peer-reviewed literature review did not reveal appropriate comprehensive definitions for market access, although several definitions were proposed from the non-peer–reviewed literature. These definitions ranged from basic to detailed. The survey of 110 respondents revealed differing levels of understanding of market access. Factors considered to influence successful market access, as described by the respondents, included unmet need/burden of disease (68.2%), clinical efficacy (47.3%), comparator choice (36.4%), safety profile (36

  10. General public knowledge, perceptions and practice towards pharmaceutical drug advertisements in the Western region of KSA.

    PubMed

    Al-Haddad, Mahmoud S; Hamam, Fayez; Al-Shakhshir, Sami M

    2014-04-01

    This study aims to examine general public knowledge and behavior toward pharmaceutical advertisements in the Western part of KSA. A cross sectional convenience sampling technique was used in this study. A total of 1445 valid questionnaires were received and analyzed using SPSS version 16 at alpha value of 0.05. Majority of respondents were aware of different types of drugs to be advertised and drug advertisements should seek approval from the health authorities. Television and Internet showed the highest effect on consumers. Almost half of the participants preferred an advertised drug over non-advertised one. Most of the respondents indicated that the quality of frequently advertised drugs is not better than those prescribed by the doctors. Majority of participants had positive beliefs toward advertised drugs concerning their role in education and spreading of awareness among the public. Pharmaceutical advertisements harm the doctor-patient relationship as evidenced by one-third of the investigated sample. Moreover, majority of the participants mentioned that they would consult another doctor or even change the current doctor if he/she refused to prescribe an advertised medication. Results of this study could be used to develop awareness programs for the general public and try to enforce the regulations and policies to protect the general public and patients from the business oriented pharmaceutical companies and drug suppliers.

  11. General public knowledge, perceptions and practice towards pharmaceutical drug advertisements in the Western region of KSA

    PubMed Central

    Al-Haddad, Mahmoud S.; Hamam, Fayez; AL-Shakhshir, Sami M.

    2013-01-01

    This study aims to examine general public knowledge and behavior toward pharmaceutical advertisements in the Western part of KSA. A cross sectional convenience sampling technique was used in this study. A total of 1445 valid questionnaires were received and analyzed using SPSS version 16 at alpha value of 0.05. Majority of respondents were aware of different types of drugs to be advertised and drug advertisements should seek approval from the health authorities. Television and Internet showed the highest effect on consumers. Almost half of the participants preferred an advertised drug over non-advertised one. Most of the respondents indicated that the quality of frequently advertised drugs is not better than those prescribed by the doctors. Majority of participants had positive beliefs toward advertised drugs concerning their role in education and spreading of awareness among the public. Pharmaceutical advertisements harm the doctor–patient relationship as evidenced by one-third of the investigated sample. Moreover, majority of the participants mentioned that they would consult another doctor or even change the current doctor if he/she refused to prescribe an advertised medication. Results of this study could be used to develop awareness programs for the general public and try to enforce the regulations and policies to protect the general public and patients from the business oriented pharmaceutical companies and drug suppliers. PMID:24648823

  12. Perceptions of per diems in the health sector: evidence and implications

    PubMed Central

    Vian, Taryn; Miller, Candace; Themba, Zione; Bukuluki, Paul

    2013-01-01

    Per diems are used to pay work-related expenses and motivate employees, yet they also can distort incentives and may be abused. This study was designed to explore perceptions of per diems among 41 high-, mid- and low-level government officers and non-governmental organization (NGO) officials in Malawi and Uganda. Interviews explored attitudes about per diems, benefits and problems for organizations and individuals, and risks and patterns of abuse. The study found that per diems provide benefits such as encouraging training, increasing staff motivation and supplementing salary. Despite these advantages, respondents voiced many discontents about per diems, stating that they create conflict, contribute to a negative organizational culture where people expect to be paid for all activities, and lead to negative changes in work time allocation. Work practices are also manipulated in order to maximize financial gain by slowing work, scheduling unnecessary trainings, or exaggerating time needed for tasks. Officials may appropriate per diems meant for others or engage in various forms of fraud for personal financial gain. Abuse seemed more common in the government sector due to low pay and weaker controls. A striking finding was the distrust that lower-level workers felt toward their superiors: allowances were perceived to provide unfair financial advantages to already better-off and well-connected staff. To curb abuse of per diems, initiatives must reduce pressures and incentives to abuse, while controlling discretion and increasing transparency in policy implementation. Donors can play a role in reform by supporting development of policy analysis tools, design of control mechanisms and evaluation of reform strategies. PMID:22684639

  13. Perceptions of per diems in the health sector: evidence and implications.

    PubMed

    Vian, Taryn; Miller, Candace; Themba, Zione; Bukuluki, Paul

    2013-05-01

    Per diems are used to pay work-related expenses and motivate employees, yet they also can distort incentives and may be abused. This study was designed to explore perceptions of per diems among 41 high-, mid- and low-level government officers and non-governmental organization (NGO) officials in Malawi and Uganda. Interviews explored attitudes about per diems, benefits and problems for organizations and individuals, and risks and patterns of abuse. The study found that per diems provide benefits such as encouraging training, increasing staff motivation and supplementing salary. Despite these advantages, respondents voiced many discontents about per diems, stating that they create conflict, contribute to a negative organizational culture where people expect to be paid for all activities, and lead to negative changes in work time allocation. Work practices are also manipulated in order to maximize financial gain by slowing work, scheduling unnecessary trainings, or exaggerating time needed for tasks. Officials may appropriate per diems meant for others or engage in various forms of fraud for personal financial gain. Abuse seemed more common in the government sector due to low pay and weaker controls. A striking finding was the distrust that lower-level workers felt toward their superiors: allowances were perceived to provide unfair financial advantages to already better-off and well-connected staff. To curb abuse of per diems, initiatives must reduce pressures and incentives to abuse, while controlling discretion and increasing transparency in policy implementation. Donors can play a role in reform by supporting development of policy analysis tools, design of control mechanisms and evaluation of reform strategies.

  14. Workplace violence: differences in perceptions of nursing work between those exposed and those not exposed: a cross-sector analysis.

    PubMed

    Hegney, Desley; Tuckett, Anthony; Parker, Deborah; Eley, Robert M

    2010-04-01

    Nurses are at high risk of incurring workplace violence during their working life. This paper reports the findings on a cross-sectional, descriptive, self-report, postal survey in 2007. A stratified random sample of 3000 of the 29 789 members of the Queensland Nurses Union employed in the public, private and aged care sectors resulted in 1192 responses (39.7%). This paper reports the differences: between those nurses who experienced workplace violence and those who did not; across employment sectors. The incidence of workplace violence is highest in public sector nursing. Patients/clients/residents were the major perpetrators of workplace violence and the existence of a workplace policy did not decrease levels of workplace violence. Nurses providing clinical care in the private and aged care sectors experienced more workplace violence than more senior nurses. Although workplace violence was associated with high work stress, teamwork and a supportive workplace mitigated workplace violence. The perception of workplace safety was inversely related to workplace violence. With the exception of public sector nursing, nurses reported an inverse relationship with workplace violence and morale.

  15. Clients’ perceptions of the quality of care in Mexico City’s public-sector legal abortion program

    PubMed Central

    Becker, Davida; Díaz-Olavarrieta, Claudia; Juárez, Clara; García, Sandra G.; Sanhueza, Patricio; Harper, Cynthia C.

    2014-01-01

    Context In 2007 the Mexico City legislature made the groundbreaking decision to legalize first trimester abortion. Limited research has been conducted to understand clients’ perceptions of the abortion services available in public sector facilities. Methods We measured clients’ perceptions of quality of care at three public sector sites in Mexico City in 2009 (n=402). We assessed six domains of quality of care (client-staff interaction, information provision, technical competence, post-abortion contraceptive services, accessibility, and the facility environment), and conducted ordinal logistic regression analysis to identify which domains were important to women for their overall evaluation of care. We measured the association of overall service evaluation with socio-demographic factors and abortion-visit characteristics, in addition to specific quality of care domains. Results Clients reported a high quality of care for abortion services with an overall mean rating of 8.8 out of 10. Multivariable analysis showed that important domains for high evaluation included client perception of doctor as technically skilled (p<0.05), comfort with doctor (p<0.001), perception of confidentiality (p<.01), perception that receptionist was respectful (p<.05) and counseling on self-care at home following the abortion and post-abortion emotions (p<0.05 and p<0.01). Other relevant domains for high evaluation were convenient site hours (p<0.01), waiting time (p<0.001) and clean facility (p<0.05). Nulliparous women rated their care less favorably than parous women (p<0.05). Conclusions Our findings highlight important domains of service quality to women’s overall evaluations of abortion care in Mexico City. Strategies to improve clients’ service experiences should focus on improving counseling, service accessibility and waiting time. PMID:22227626

  16. International Students' Perceptions of Service Quality in the UK Banking Sector: An Exploratory Study

    ERIC Educational Resources Information Center

    Bond, Christopher; Hsu, Marc Ting-Chun

    2011-01-01

    This study reviews and evaluates international students' perceptions of UK banks. The specific research objectives were to identify international students' expectations and perceptions of service quality from UK banks and to assess the quality GAP or dissonance between these. A total of 297 international students studying in the UK responded to…

  17. Perceptions of Craftsmen and Apprentices Regarding Self-Employment Skill Acquisition in the Kenyan Informal Sector.

    ERIC Educational Resources Information Center

    Nelson, Robert E.; K'Aol, George O.

    1997-01-01

    Interviews with 52 craft workers and 52 apprentices in Kenya found that apprentices had more formal education and 76.9% of craft workers acquired technical skills informally. Both groups felt self-employment skills were not well taught in the informal sector, despite the need for business planning, bookkeeping, marketing, and other skills. (SK)

  18. Stepping into Higher Education from the Vocational Education Sector in Australia: Student Perceptions and Experiences

    ERIC Educational Resources Information Center

    O'Shea, Sarah; Lysaght, Pauline; Tanner, Kathleen

    2012-01-01

    It is not unusual to hear study in the vocational education sector referred to as a "stepping stone" into further studies in the higher education environment. What this pathway entails for those who choose it is not immediately clear however. This article reports on research conducted with a small cohort of students who arrived at an…

  19. Consumer perception of meat quality and implications for product development in the meat sector-a review.

    PubMed

    Grunert, Klaus G; Bredahl, Lone; Brunsø, Karen

    2004-02-01

    In the first part of the paper, the Total Food Quality Model is used as a frame of reference for analysing the way in which consumers perceive meat quality, drawing mainly on European studies involving beef and pork. The way in which consumers form expectations about quality at the point of purchase, based on their own experience and informational cues available in the shopping environment, is described, as well as the way in which quality is experienced in the home during and after meal preparation. The relationship between quality expectations and quality experience and its implications for consumer satisfaction and repeat purchase intent is addressed. In the second part of the paper, and building on the insights obtained on subjective quality perception, possibilities for consumer-oriented product development in the meat sector are addressed. Issues dealt with here are branding, differentiation by taste, healthiness and convenience, and by process characteristics like organic production and animal welfare.

  20. Does labour epidural slow the progress of labour and lead to complications? Obstetricians’ perception working in private and public sector teaching hospitals in a developing country

    PubMed Central

    Sohaib, Muhammad; Ismail, Samina

    2015-01-01

    Background and Aims: Obstetricians play a major role in the decision making for provision of analgesia for the woman in labour. As epidural analgesia (EA) is the most preferred technique, it is important to know obstetricians' perception regarding its effect on progress of labour and associated complications. Methods: The 6 months cross-sectional study included 114 obstetricians from teaching hospitals. After informed consent, obstetricians were asked to fill a predesigned questionnaire containing 13 close ended questions regarding their perception on the effect of EA on progress of labour, EA complications and whether they would recommend EA to their patients or not. Other variables included age, gender, training in EA, practice type and hospital settings (private or public sector). Results: Majority of the obstetricians had the perception of EA prolonging the first stage (89.5%) and second stage (98.2%) of labour, increasing the rate of caesarean section (87.7%), instrumental delivery (58.8%) and increasing the incidence of backache (85.5%). None of the obstetricians received any formal training in EA. Majority (84.2%) were not sure if they would recommend EA to their patients. When these responses were compared between public and private sector, a statistically higher percentage (P < 0.001) of public sector obstetricians had negative perception of EA. Conclusion: Perception of obstetrician regarding EA is contrary to the current evidence. There is a need to introduce formal curriculum on EA in obstetric training program and conduct regular refresher courses. PMID:26903670

  1. FDA pharmaceutical quality oversight.

    PubMed

    Yu, Lawrence X; Woodcock, Janet

    2015-08-01

    The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale.

  2. Exploring Typical and Atypical Safety Climate Perceptions of Practitioners in the Repair, Maintenance, Minor Alteration and Addition (RMAA) Sector in Hong Kong

    PubMed Central

    Hon, Carol K.H.; Liu, Yulin

    2016-01-01

    The safety of repair, maintenance, minor alteration and addition (RMAA) work is an under-explored area. This study explored the typical and atypical safety climate perceptions of practitioners in the RMAA sector in Hong Kong, based on a self-administered questionnaire survey of 662 local practitioners in the industry. Profile analysis, via multidimensional scaling of the respondents’ scores of three safety climate scales, identified one typical perception: high in management commitment to occupational health and safety (OHS) and employee involvement, low in applicability for safety rules and regulations, and low in responsibility for OHS. The respondents were clustered into typical and atypical perception groups according to their safety climate scores’ match to the typical perception. A comparison of demographics between the two groups with logistic regression found that work level and direct employer significantly affect their classification. A multivariate analysis of variance of safety performance measures between the two groups indicated that the typical group had a significantly higher level of safety compliance than the atypical group, with no significant difference in safety participation or injury. The significance of this study lies in revealing the typical safety climate perception profile pattern of RMAA works and offering a new perspective of safety climate research. PMID:27669269

  3. Percept

    SciTech Connect

    2014-11-26

    The Percept software package is a collection of libraries and executables that provide tools for verifying computer simulations of engineering components and systems. Percept is useful for simulations using the finite element or finite volume methods on unstructured meshes. Percept includes API's for adaptive mesh refinement, geometry representation, the method of manufactured solutions, analysis of convergence including the convergence of vibrational eigenmodes, and metrics for analyzing the difference between fields represented on two different overlapping unstructured grids.

  4. 21 CFR 26.17 - Role and composition of the Joint Sectoral Committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE... EUROPEAN COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.17...

  5. 21 CFR 26.17 - Role and composition of the Joint Sectoral Committee.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE... EUROPEAN COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.17...

  6. 21 CFR 26.17 - Role and composition of the Joint Sectoral Committee.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE... EUROPEAN COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.17...

  7. 21 CFR 26.17 - Role and composition of the Joint Sectoral Committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE... EUROPEAN COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.17...

  8. Staff Involvement in Leadership Decision Making in the UK Further Education Sector: Perceptions of Quality and Social Justice

    ERIC Educational Resources Information Center

    Maringe, Felix

    2012-01-01

    Purpose: The purpose of the paper is to explore the quality of leadership decision making at various leadership levels in the further education (FE) sector. Using Hoffberg and Korver's model for integrated decision making, the paper aims to examine how staff in five UK FE colleges perceive the quality of their involvement in decision-making teams…

  9. Pandemic preparedness: perceptions of vulnerable migrants in Thailand towards WHO-recommended non-pharmaceutical interventions: a cross-sectional study

    PubMed Central

    2014-01-01

    Background Non-pharmaceutical interventions (NPIs) constituted the principal public health response to the previous influenza A (H1N1) 2009 pandemic and are one key area of ongoing preparation for future pandemics. Thailand is an important point of focus in terms of global pandemic preparedness and response due to its role as the major transportation hub for Southeast Asia, the endemic presence of multiple types of influenza, and its role as a major receiving country for migrants. Our aim was to collect information about vulnerable migrants’ perceptions of and ability to implement NPIs proposed by the WHO. We hope that this information will help us to gauge the capacity of this population to engage in pandemic preparedness and response efforts, and to identify potential barriers to NPI effectiveness. Methods A cross-sectional survey was performed. The study was conducted during the influenza H1N1 2009 pandemic and included 801 migrant participants living in border areas thought to be high risk by the Thailand Ministry of Public Health. Data were collected by Migrant Community Health Workers using a 201-item interviewer-assisted questionnaire. Univariate descriptive analyses were conducted. Results With the exception of border measures, to which nearly all participants reported they would be adherent, attitudes towards recommended NPIs were generally negative or uncertain. Other potential barriers to NPI implementation include limited experience applying these interventions (e.g., using a thermometer, wearing a face mask) and inadequate hand washing and household disinfection practices. Conclusions Negative or ambivalent attitudes towards NPIs combined with other barriers identified suggest that vulnerable migrants in Thailand have a limited capacity to participate in pandemic preparedness efforts. This limited capacity likely puts migrants at risk of propagating the spread of a pandemic virus. Coordinated risk communication and public education are potential

  10. [Are tick medications pesticides? Implications for health and risk perception for workers in the dairy cattle sector].

    PubMed

    da Silva, Tatiana Pastorello Pereira; Moreira, Josino Costa; Peres, Frederico

    2012-02-01

    This article seeks to characterize the risks related to the use of pesticides in dairy production, in terms of legislation, health and perception of risk for workers involved in this activity. It is based on methodological articulation that included: a) systematic review of the reference literature on the research topic; b) analysis of related legislation (veterinary products and pesticides); c) risk identification regarding the use of veterinary products formulated using active ingredients listed as pesticides; d) and risk perception analysis of a group of dairy production workers. Results indicate a situation of particular interest to Public Health. Regarding dairy production workers, the invisibility of risks associated with handling pesticides for veterinary use, increases their exposure and is related to several health problems, especially for women. This same invisibility leads to a neglect of the prohibition period between pesticide use and consumption of other products. Part of the problem may be associated with the non-classification of pesticides for veterinary use as 'pesticides' (they are classified as veterinary products), which highlights the importance and the urgency of discussion of the theme.

  11. The Impact of a Microfinance Program on Client Perceptions of the Quality of Care Provided by Private Sector Midwives in Uganda

    PubMed Central

    Agha, Sohail; Balal, Asma; Ogojo-Okello, Francis

    2004-01-01

    Objective To assess the impact of a microfinance program that provided business skills training and revolving loans to private sector midwives on perceived quality of services and client loyalty. Study Design A quasi-experimental study with a pretest, posttest design was used to evaluate the impact of the intervention. Exit interviews were conducted at 15 clinics that received the intervention and 7 clinics that did not. Baseline exit interviews were conducted between November and December 2000. Five days of business skills training were provided to midwives, and loans (averaging $454) were given during January and February 2001. A follow-up clinic visit was made to assess whether midwives were implementing what was emphasized during the training. The loans were to be repaid with interest within 6 to 12 months, at an interest rate that is standard within the local commercial market. For those who repaid the first set of loans (11 clinics), a second set of loans (averaging $742) was provided after June 2001. Follow-up exit interviews were conducted at the same clinics between February and March 2002. We assessed the effect of the intervention at both clinic and client levels. T-tests, the analysis of variance, and multivariate logistic regression analysis were conducted. Principal Findings These findings should be interpreted cautiously since secular trends were observed during the study period. The intervention was associated with improvement in clients' perceptions of the quality of care received at intervention clinics. The intervention was also associated with a higher level of client loyalty. Conclusions The enthusiastic response of midwives and the high loan repayment rate indicate that midwives were very receptive to the microfinance program. Overall, these findings suggest that microfinance may have an important role in strengthening private sector health services by increasing private providers' business skills and clients' satisfaction with services. PMID

  12. Patients' Perception of Clinicians Use of ICT During Patient Consultation in the Different Sectors of Danish Healthcare.

    PubMed

    Petersen, Lone Stub; Bertelsen, Pernille

    2016-01-01

    In Denmark ICT is a central part of almost all healthcare professionals' daily practices, and patients are increasingly encouraged to take and active interest in own health data. Therefore, ICT is an important part of what happens at consultations between the patients and the healthcare professionals. We explore the impact of ICT based on a survey of citizens'/patients' experience of interaction with healthcare professionals. How often and for what ICT was used in communication with the patients in different sectors of the Danish healthcare. The results show that ICT is used in communication with citizens and during interaction with patient, however the use of ICT is mostly for the healthcare professionals own benefit and only about 15%-39% of the reported instances ICT was used to communication and interact with the patient. Through the concept of boundary objects we proposes a model that split the object of the technology mediated information into three setting for communication between patients and healthcare professionals. We propose further studies into how ICT can be used to explore the possibilities for more interactive and involving care processes as a key element in further development of eHealth.

  13. Pharmaceutical laws and regulations in Iran: An overview

    PubMed Central

    Zaboli, Pardis; Hashemi-Meshkini, Amir; Varmaghani, Mehdi; Gholami, Hadi; Vazirian, Iman; Zekri, Hedieh-Sadat; Eslamitabar, Shahriar; Kebriaeezadeh, Abbas

    2016-01-01

    The pharmaceutical legal framework is a very important infrastructure in achieving predefined goals in pharmaceutical sector: Accessibility, quality, and rational use of medicine. This study aims to review the current pharmaceutical sector-related legal provisions in Iran where the Food and Drug Organization (FDO) is in charge of regulating all issues related to the pharmaceutical sector. The main laws and regulations enacted by parliament and cabinet and even internal regulations enacted by the Ministry of Health or Iran FDO are reviewed. Different laws and regulations are categorized according to the main goals of Iran national drug policy. PMID:27512704

  14. Patients’ perception of pharmaceutical services available in a community pharmacy among patients living in a rural area of the United Kingdom

    PubMed Central

    2016-01-01

    Objective: Patients’ opinion about prevalence of pharmaceutical services available in a community pharmacy among patients living in a rural area of the United Kingdom. The secondary objective was to identify appropriate action(s) to enhance patients’ awareness of pharmaceutical services in rural areas. Methods: A self-administered, anonymous questionnaire was distributed to patients visiting a community pharmacy in Eye, Suffolk, United Kingdom between July and August, 2015. The main inclusion criterion was living in a rural area. Comparisons were performed using chi-square tests and logistic regression. Results: The study included 103 respondents: 70 women (69.0%) and 33 men (32.0%), aged 16–85 years. Most respondents declared the primary tasks of a community pharmacy were dispensing medicines (86.4% of respondents) and repeat dispensing (72.8% of respondents). Additionally, 23.3% of respondents treated minor ailments at the pharmacy, including bacterial/viral infections, minor injuries, stomach problems, and allergies. The Medicines Use Review service was the only advanced service used in this pharmacy (12.6% of respondents), primarily by men. Younger patients were more familiar with the term of pharmaceutical care (p<0.05; OR=0.33). Conclusions: Only a few pharmaceutical services are utilized by people living in rural areas in the UK, namely prescription dispensing, repeat dispensing, and sale of medications that support self-care for minor ailments. We found an overall poor awareness of the expanded variety of pharmaceutical services encouraged by the community pharmacy contract introduced in the UK in 2005. Therefore, politicians, pharmacists, and pharmacy experts should actively promote these advanced pharmaceutical services in rural areas. PMID:27785163

  15. Current perceptions of the term Clinical Pharmacy and its relationship to Pharmaceutical Care: a survey of members of the European Society of Clinical Pharmacy.

    PubMed

    Dreischulte, Tobias; Fernandez-Llimos, Fernando

    2016-12-01

    Background The definitions that are being used for the terms 'clinical pharmacy' and 'pharmaceutical care' seem to have a certain overlap. Responsibility for therapy outcomes seems to be especially linked to the latter term. Both terms need clarification before a proper definition of clinical pharmacy can be drafted. Objective To identify current disagreements regarding the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care' and to assess to which extent pharmacists with an interest in Clinical Pharmacy are willing to accept responsibility for drug therapy outcomes. Setting The membership of the European Society of Clinical Pharmacy. Methods A total of 1,285 individuals affiliated with the European Society of Clinical Pharmacy were invited by email to participate in an online survey asking participants to state whether certain professional activities, providers, settings, aims and general descriptors constituted (a) 'Clinical Pharmacy only', (b) 'Pharmaceutical Care only', (c) 'both' or (d) 'neither'. Further questions examined pharmacists' willingness to accept ethical or legal responsibility for drug therapy outcomes, under current and ideal working conditions. Main outcome measures Level of agreement with a number of statements. Results There was disagreement (<80% agreement among all participants) regarding 'Clinical Pharmacy' activities, whether non-pharmacists could provide 'Clinical Pharmacy' services, and whether such services could be provided in non-hospital settings. There was disagreement (<80% agreement among those linking items to Clinical Pharmacy) as to whether Pharmaceutical care also encompassed certain professional activities, constituted a scientific discipline and targeted cost effectiveness. The proportions of participants willing to accept legal responsibility under current/ideal working conditions were: safety (32.7%/64.3%), effectiveness (17.9%/49.2%), patient-centeredness (17.1%/46.2%), cost-effectiveness (20

  16. Pharmaceutical virtue.

    PubMed

    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.

  17. Agriculture Sectors

    EPA Pesticide Factsheets

    The Agriculture sectors comprise establishments primarily engaged in growing crops, raising animals, and harvesting fish and other animals. Find information on compliance, enforcement and guidance on EPA laws and regulations on the NAICS 111 & 112 sectors.

  18. When Government Is No Longer Employer of Choice: What May the Sector Perceptions of Public Managers Be Like after the Economy Recovers?

    ERIC Educational Resources Information Center

    Boardman, Craig; Ponomariov, Branco

    2012-01-01

    In today's economic climate, government is now considered by many to be the "employer of choice." However, employers at all levels of government may eventually lose their recent gains in the war for talent, as the economy improves. Accordingly, it is important to explain how public sector managers viewed the relative advantages and…

  19. Bioremediation of industrial pharmaceutical drugs.

    PubMed

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

    2012-07-01

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

  20. Pharmaceutical marketing research and the prescribing physician.

    PubMed

    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.

  1. Metals Sector

    EPA Pesticide Factsheets

    Find environmental regulatory information about the metals sector (NAICS 331 & 332), including NESHAPs for metal coatings, effluent guidelines for metal products, combustion compliance assistance, and information about foundry sand recycling.

  2. Medical students' perception of the progress test as a quality-controlled assessment tool for improving learning and teaching, at a public sector medical college in Saudi Arabia.

    PubMed

    Sattar, Kamran; Ahmad, Tauseef; Khalil, Mahmoud Salah; Soliman, Mona Mohamed; Punnamperuma, Gominda Giatry; Abdulghani, Hamza Mohammad

    2017-02-01

    Progress test's distinguishing characteristics make it pertinent worldwide. We explored medical students' perceptions and opinions about Progress Test (PT) with a view to identifying areas concomitant with it's execution. This cross-sectional study took place at College of Medicine, Saudi Arabia, during the academic year 2015-16. A questionnaire (14 items) was administered. Reason for majority n=96 (89.7%) of the total participants to take the PT was their keenness to compare their academic standing with their peers from other participating medical colleges. The majority of students were highly satisfied with PT implementation; i.e. its orientation (58.9%) and allocated time (90.7%). Students (76.6%) considered PT to offer academic support as future physicians. Students (75.7%) also agreed to participate in the future PT. Students being highly satisfied with the organization of PT. They found it to be a tool helping them to focus on improving the knowledge domain.

  3. Do cost-sharing and entry deregulation curb pharmaceutical innovation?

    PubMed

    Grossmann, Volker

    2013-09-01

    This paper examines the role of both cost-sharing schemes in health insurance systems and the regulation of entry into the pharmaceutical sector for pharmaceutical R&D expenditure and drug prices. The analysis suggests that both an increase in the coinsurance rate and stricter price regulations adversely affect R&D spending in the pharmaceutical sector. In contrast, entry deregulation may lead to higher R&D spending of pharmaceutical companies. The relationship between R&D spending per firm and the number of firms may be hump-shaped. In this case, the number of rivals which maximizes R&D expenditure per firm is decreasing in the coinsurance rate and increasing in labor productivity.

  4. Pharmaceutical cocrystals: an overview.

    PubMed

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

    2011-10-31

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

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

    PubMed

    Semin, Semih; Güldal, Dilek

    2008-01-01

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

  6. Pharmaceutical Education in Nigeria.

    ERIC Educational Resources Information Center

    Oyegbile, F. Rachel

    1988-01-01

    Nigeria has six pharmacy schools, most offering graduate programs. The undergraduate program is being expanded from four to five years. Although behavioral and clinical sciences are offered, emphasis is on the pharmaceutical sciences. Overall, pharmaceutical education is oriented toward hospice practice. (Author/MSE)

  7. Radiation treatment of pharmaceuticals

    NASA Astrophysics Data System (ADS)

    Dám, A. M.; Gazsó, L. G.; Kaewpila, S.; Maschek, I.

    1996-03-01

    Product specific doses were calculated for pharmaceuticals to be radiation treated. Radio-pasteurization dose were determined for some heat sensitive pharmaceutical basic materials (pancreaton, neopancreatin, neopancreatin USP, duodenum extract). Using the new recommendation (ISO standards, Method 1) dose calculations were performed and radiation sterilization doses were determined for aprotinine and heparine Na.

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

    PubMed

    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.

  9. Inkjet printing for pharmaceutics - A review of research and manufacturing.

    PubMed

    Daly, Ronan; Harrington, Tomás S; Martin, Graham D; Hutchings, Ian M

    2015-10-30

    Global regulatory, manufacturing and consumer trends are driving a need for change in current pharmaceutical sector business models, with a specific focus on the inherently expensive research costs, high-risk capital-intensive scale-up and the traditional centralised batch manufacturing paradigm. New technologies, such as inkjet printing, are being explored to radically transform pharmaceutical production processing and the end-to-end supply chain. This review provides a brief summary of inkjet printing technologies and their current applications in manufacturing before examining the business context driving the exploration of inkjet printing in the pharmaceutical sector. We then examine the trends reported in the literature for pharmaceutical printing, followed by the scientific considerations and challenges facing the adoption of this technology. We demonstrate that research activities are highly diverse, targeting a broad range of pharmaceutical types and printing systems. To mitigate this complexity we show that by categorising findings in terms of targeted business models and Active Pharmaceutical Ingredient (API) chemistry we have a more coherent approach to comparing research findings and can drive efficient translation of a chosen drug to inkjet manufacturing.

  10. Amorphous pharmaceutical solids.

    PubMed

    Vranić, Edina

    2004-07-01

    Amorphous forms are, by definition, non-crystalline materials which possess no long-range order. Their structure can be thought of as being similar to that of a frozen liquid with the thermal fluctuations present in a liquid frozen out, leaving only "static" structural disorder. The amorphous solids have always been an essential part of pharmaceutical research, but the current interest has been raised by two developments: a growing attention to pharmaceutical solids in general, especially polymorphs and solvates and a revived interest in the science of glasses and the glass transition. Amorphous substances may be formed both intentionally and unintentionally during normal pharmaceutical manufacturing operations. The properties of amorphous materials can be exploited to improve the performance of pharmaceutical dosage forms, but these properties can also give rise to unwanted effects that need to be understood and managed in order for the systems to perform as required.

  11. Ecotoxicology of human pharmaceuticals.

    PubMed

    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.

  12. Paradigms in Pharmaceutical Education: Views of a Paradigm Shifter.

    ERIC Educational Resources Information Center

    Hadda, Amy Marie

    1992-01-01

    The pharmacist as a provider of "pharmaceutical care" is examined both as a notion and as a new example for training practitioners. It is concluded that the example will require more from the pharmacist of the future and a reordering of perceptions about the nature of the pharmacy profession. (MSE)

  13. Impacts of international sanctions on Iranian pharmaceutical market.

    PubMed

    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.

  14. Impacts of international sanctions on Iranian pharmaceutical market

    PubMed Central

    2013-01-01

    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. PMID:23902642

  15. Regulatory Information By Sector

    EPA Pesticide Factsheets

    Find environmental regulatory, compliance, & enforcement information for various business, industry and government sectors, listed by NAICS code. Sectors include agriculture, automotive, petroleum manufacturing, oil & gas extraction & other manufacturing

  16. [Fourcroy and pharmaceutical journals].

    PubMed

    Bonnemain, Bruno

    2011-04-01

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

  17. PHARMACEUTICALS IN THE ENVIRONMENT: OVERVIEW ...

    EPA Pesticide Factsheets

    Pharmaceuticals and personal care products (PPCPs) comprise large, diverse arrays of chemicals that can occur in the environment as unregulated pollutants. They originate largely from the combined activities and actions of multitudes of individuals as well as from veterinary and agricultural use; the wide spectrum of sources and origins of PPCPs. Concerted research that began in Europe about two decades ago, and in the U.S. in the late 1990s, has been rapidly expanding in the last few years, as reflected by an escalation in publications. Investigations that were originally limited to studying the sources, origins, and occurrence of PPCPs (mainly in waters) were led primarily by analytical chemists. The scope of this research has expanded, now accommodating more dimensions of the risk assessment paradigm. The scope has widened to encompass not just occurrence over a wider spectrum of environmental matrices but also to address the complexities involved with assessing the range of unanticipated and subtle effects that might occur from chronic, low-dose exposure of non-target organisms (Daughton 2003a; Daughton and Ternes 1999). Risk management options designed around the principles of pollution prevention and environmental stewardship are also under discussion in the many sectors of the healthcare community and by various state and local legislatures The research focused on in the subtasks is the development and application of state-of the-art technologies to meet

  18. Reflections on Pharmaceutical Education.

    ERIC Educational Resources Information Center

    Smith, Robert E.

    1992-01-01

    A discussion of the implications of adopting a new example for pharmaceutical education focuses on the need to develop a new pharmacy college culture and on the faculty's role in addressing stated educational goals. Anticipated changes in staffing and faculty development and difficulties in reorganizing curricula are examined. (MSE)

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

    PubMed Central

    Barouni, M; Ghaderi, H; Banouei, AA

    2012-01-01

    Background Computable general equilibrium models are known as a powerful instrument in economic analyses and widely have been used in order to evaluate trade liberalization effects. The purpose of this study was to provide the impacts of trade openness on pharmaceutical industry using CGE model. Methods: Using a computable general equilibrium model in this study, the effects of decrease in tariffs as a symbol of trade liberalization on key variables of Iranian pharmaceutical products were studied. Simulation was performed via two scenarios in this study. The first scenario was the effect of decrease in tariffs of pharmaceutical products as 10, 30, 50, and 100 on key drug variables, and the second was the effect of decrease in other sectors except pharmaceutical products on vital and economic variables of pharmaceutical products. The required data were obtained and the model parameters were calibrated according to the social accounting matrix of Iran in 2006. Results: The results associated with simulation demonstrated that the first scenario has increased import, export, drug supply to markets and household consumption, while import, export, supply of product to market, and household consumption of pharmaceutical products would averagely decrease in the second scenario. Ultimately, society welfare would improve in all scenarios. Conclusion: We presents and synthesizes the CGE model which could be used to analyze trade liberalization policy issue in developing countries (like Iran), and thus provides information that policymakers can use to improve the pharmacy economics. PMID:23641393

  20. EU pharmaceutical expenditure forecast

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    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.

  2. Gray marketing of pharmaceuticals.

    PubMed

    Chaudhry, P E; Walsh, M G

    1995-01-01

    Pharmaceutical marketers in the European Union are constrained by regulated prices, opening up opportunities for gray marketers. The authors investigate the legal framework that regulates gray markets by summarizing and analyzing relevant European Court of Justice decisions that favor gray marketers and actually foster parallel trade. Before marketing managers can develop effective strategies in this marketplace, they must first understand the precedents of the legal system in which they will be operating.

  3. Why Lunch Matters: Assessing Physicians' Perceptions about Industry Relationships

    ERIC Educational Resources Information Center

    Fugh-Berman; Adriane J.; Scialli, Anthony R.; Bell, Alicia M.

    2010-01-01

    Many studies have shown that pharmaceutical marketing affects prescribing choices. Studies that have assessed the effects of educational interventions on perceptions of pharmaceutical promotion have found mixed results. This study assesses the short-term effects of an educational intervention about marketing tactics on the attitudes and fund of…

  4. Effects of Information on College Students' Perceptions of Antidepressant Medication

    ERIC Educational Resources Information Center

    Frankenberger, Kristi A.; Frankenberger, William R.; Peden, Blaine F.; Hunt, Heather L.; Raschick, Christopher M.; Steller, Emily G.; Peterson, Jaclyn A.

    2004-01-01

    The authors examined the impact of pharmaceutical companies' advertisements on college students' perceptions of depression and concomitant treatment with antidepressants among 13 male and 31 female undergraduates from a midwestern university. The students were randomly assigned to groups that read either pharmaceutical company advertisements or…

  5. Trade, TRIPS, and pharmaceuticals.

    PubMed

    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.

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

    PubMed

    Amara, Amro Abd-Al-Fattah

    2013-01-01

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

  7. Bolaamphiphiles: A Pharmaceutical Review

    PubMed Central

    Fariya, Mayur; Jain, Ankitkumar; Dhawan, Vivek; Shah, Sanket; Nagarsenker, Mangal S.

    2014-01-01

    The field of drug discovery is ever growing and excipients play a major role in it. A novel class of amphiphiles has been discussed in the review. The review focuses on natural as well as synthetic bolaamphiphiles, their chemical structures and importantly, their ability to self assemble rendering them of great use to pharmaceutical industry. Recent reports on their ability to be used in fabrication of suitable nanosized carriers for drug as well as genes to target site, has been discussed substantially to understand the potential of bolaamphiphiles in field of drug delivery. PMID:25671179

  8. Is the United States still dominant in the global pharmaceutical innovation network?

    PubMed

    Hu, Yuanjia; Scherngell, Thomas; Man, Si Nga; Wang, Yitao

    2013-01-01

    The dramatic growth of research and development activities in the pharmaceutical sector in emerging economies raises the question of whether the United States still keeps its dominant role in the global pharmaceutical innovation landscape. This paper focuses on investigating the role of the United States in global pharmaceutical innovation, and differs from previous studies by shifting attention to a network analytic perspective to track the global distribution of pharmaceutical inventions. Our sample is composed of key patents covering all new drugs approved by the Food and Drug Administration between 1996 and 2010. The results show that the United States still dominates in the global pharmaceutical innovation network, especially when it comes to essential core inventions. However, the United States shows a slightly decreasing prominence in the networks of either total new drugs or New Molecular Entity (NME) drugs in the time period 2006-2010 as compared to previous time periods, revealed by subtle traces of network centralities.

  9. Is the United States Still Dominant in the Global Pharmaceutical Innovation Network?

    PubMed Central

    Hu, Yuanjia; Scherngell, Thomas; Man, Si Nga; Wang, Yitao

    2013-01-01

    The dramatic growth of research and development activities in the pharmaceutical sector in emerging economies raises the question of whether the United States still keeps its dominant role in the global pharmaceutical innovation landscape. This paper focuses on investigating the role of the United States in global pharmaceutical innovation, and differs from previous studies by shifting attention to a network analytic perspective to track the global distribution of pharmaceutical inventions. Our sample is composed of key patents covering all new drugs approved by the Food and Drug Administration between 1996 and 2010. The results show that the United States still dominates in the global pharmaceutical innovation network, especially when it comes to essential core inventions. However, the United States shows a slightly decreasing prominence in the networks of either total new drugs or New Molecular Entity (NME) drugs in the time period 2006–2010 as compared to previous time periods, revealed by subtle traces of network centralities. PMID:24223710

  10. Pharmaceutical Education and the Translation of Pharmaceutical Care into Practice.

    ERIC Educational Resources Information Center

    Newton, Gail D.

    1991-01-01

    A systematic approach to reform of pharmaceutical education is seen as necessary to link intended outcomes of reform to a progressive and generally accepted mission of professional practice. Cooperation between pharmaceutical education, professional organizations, and regulatory agencies is viewed as necessary and refinement of professional…

  11. Deliquescence of pharmaceutical systems.

    PubMed

    Mauer, Lisa J; Taylor, Lynne S

    2010-12-01

    Deliquescence is a first order phase transition from solid to solution that occurs at a relative humidity (RH) that is characteristic to the crystalline compound. Such dissolution of active pharmaceutical ingredients and excipients can lead to detrimental physical and chemical instabilities. Furthermore, in systems containing more than one deliquescent component, the RH of the solid-solution transition will be lowered, leading to some level of dissolution at unexpectedly low RH conditions. Deliquescence lowering is independent of the ratio of the deliquescent components and therefore is of concern for any formulation containing two or more deliquescent compounds. Because chemical reactions occur much more readily in solution, deliquescence will enhance the degradation of labile APIs. RH fluctuations will lead to cycles of deliquescence and efflorescence (crystallization), which will contribute to particle agglomeration and caking. This review will address the phenomenon of deliquescence, the significance of deliquescence to pharmaceutical systems, measurement techniques, the kinetics and thermodynamics of deliquescence, the behavior of mixtures of deliquescent compounds (including phase diagrams and thermodynamics of binary systems), and consequences of deliquescence on chemical and physical stability.

  12. The Pharmaceutical Commons

    PubMed Central

    Lezaun, Javier

    2015-01-01

    In the last decade, the organization of pharmaceutical research on neglected tropical diseases has undergone transformative change. In a context of perceived “market failure,” the development of new medicines is increasingly handled by public-private partnerships. This shift toward hybrid organizational models depends on a particular form of exchange: the sharing of proprietary assets in general and of intellectual property rights in particular. This article explores the paradoxical role of private property in this new configuration of global health research and development. Rather than a tool to block potential competitors, proprietary assets function as a lever to attract others into risky collaborative ventures; instead of demarcating public and private domains, the sharing of property rights is used to increase the porosity of that boundary. This reimagination of the value of property is connected to the peculiar timescape of global health drug development, a promissory orientation to the future that takes its clearest form in the centrality of “virtual” business models and the proliferation of strategies of deferral. Drawing on the anthropological literature on inalienable possessions, we reconsider property’s traditional exclusionary role and discuss the possibility that the new pharmaceutical “commons” proclaimed by contemporary global health partnerships might be the precursor of future enclosures. PMID:25866425

  13. The Future of Pharmaceutical Manufacturing Sciences

    PubMed Central

    2015-01-01

    The entire pharmaceutical sector is in an urgent need of both innovative technological solutions and fundamental scientific work, enabling the production of highly engineered drug products. Commercial‐scale manufacturing of complex drug delivery systems (DDSs) using the existing technologies is challenging. This review covers important elements of manufacturing sciences, beginning with risk management strategies and design of experiments (DoE) techniques. Experimental techniques should, where possible, be supported by computational approaches. With that regard, state‐of‐art mechanistic process modeling techniques are described in detail. Implementation of materials science tools paves the way to molecular‐based processing of future DDSs. A snapshot of some of the existing tools is presented. Additionally, general engineering principles are discussed covering process measurement and process control solutions. Last part of the review addresses future manufacturing solutions, covering continuous processing and, specifically, hot‐melt processing and printing‐based technologies. Finally, challenges related to implementing these technologies as a part of future health care systems are discussed. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3612–3638, 2015 PMID:26280993

  14. Mineral Processing Sector

    EPA Pesticide Factsheets

    Find environmental regulatory and compliance information for the nonmetallic mineral processing sector (NAICS 327), including NESHAPs for asbestos and hazardous waste, and wastewater permit information.

  15. Designing a Pharmaceutical Care Curriculum.

    ERIC Educational Resources Information Center

    Perrier, Donald G.; And Others

    1995-01-01

    Guidelines for developing a pharmacy school curriculum based on the principle of pharmaceutical care and professional responsibility are offered, beginning with mission statements for profession, practice, and pharmaceutical education in general. The University of Toronto experience in designing such a curriculum is chronicled as an illustration…

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

    PubMed

    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.

  17. Naming, labeling, and packaging of pharmaceuticals.

    PubMed

    Kenagy, J W; Stein, G C

    2001-11-01

    The problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals is discussed. Sound-alike and look-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient injury or death. The existing medication-use system is flawed because its safety depends on human perfection. Simplicity, standardization, differentiation, lack of duplication, and unambiguous communication are human factors concepts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, current methods are based on long-standing commercial considerations and bureaucratic procedures. The process for naming a marketable drug is lengthy and complex and involves submission of a new chemical entity and patent application, generic naming, brand naming, FDA review, and final approval. Drug companies seek the fastest possible approval and may believe that the incremental benefit of human factors evaluation is small. "Trade dress" is the concept that underlies labeling and packaging issues for the drug industry. Drug companies are resistant to changing trade dress and brand names. Although a variety of private-sector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem remains. Drug names, labels, and packages are not selected and designed in accordance with human factors principles. FDA standards do not require application of these principles, the drug industry has struggled with change, and private-sector initiatives have had only limited success.

  18. Problematizing ‘drugs’: A cultural assessment of recreational pharmaceutical use among young adults in the US

    PubMed Central

    QUINTERO, GILBERT

    2013-01-01

    Recent trends in the recreational use of pharmaceuticals among young adults in the United States highlight a number of issues regarding the problematization of drugs. Two constructions of recreational pharmaceutical use are analyzed. On the one hand, categorical frameworks based upon epidemiological data are created by institutions and media and depict recreational pharmaceutical use as illicit in unqualified, absolute terms. This is done through discourses that equate nonmedical pharmaceutical use with culturally established forms of illicit drug use. On the other hand, users’ multi-dimensional constructions of recreational pharmaceutical use emphasise social context, personal experience, and individual risk perceptions. The problematization of recreational pharmaceutical use points to intergenerational conflicts, as well as to struggles over definitions of “drug abuse” and “hard drugs”, and highlights the impact of pharmaceuticalization on recreational drug use among young people. PMID:24431478

  19. [Pharmaceuticals: a strategic national industry].

    PubMed

    Hollender, Louis

    2004-01-01

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

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

    PubMed

    Huff-Rousselle, M; Burnett, F

    1996-01-01

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

  1. Pharmaceutical health care and Inuit language communications in Nunavut, Canada

    PubMed Central

    Romain, Sandra J.

    2013-01-01

    Background Pharmaceutical communication is an essential component of pharmaceutical health care, optimally ensuring patients understand the proper administration and side effects of their medications. Communication can often be complicated by language and culture, but with pharmaceuticals, misunderstandings can prove particularly harmful. In Nunavut, to ensure the preservation and revitalization of Inuit languages, the Inuit Language Protection Act and Official Languages Act were passed requiring that all public and private sector essential services offer verbal and written communication in Inuit languages (Inuktitut and Inuinnaqtun) by 2012. Methods While the legislation mandates compliance, policy implementation for pharmaceutical services is problematic. Not a single pharmacist in Nunavut is fluent in either of the Inuit languages. Pharmacists have indicated challenges in formally translating written documentation into Inuit languages based on concerns for patient safety. These challenges of negotiating the joint requirements of language legislation and patient safety have resulted in pharmacies using verbal on-site translation as a tenuous solution regardless of its many limitations. Results The complex issues of pharmaceutical health care and communication among the Inuit of Nunavut are best examined through multimethod research to encompass a wide range of perspectives. This methodology combines the richness of ethnographic data, the targeted depth of interviews with key informants and the breadth of cross-Canada policy and financial analyses. Conclusions The analysis of this information would provide valuable insights into the current relationships between health care providers, pharmacists and Inuit patients and suggest future directions for policy that will improve the efficacy of pharmaceuticals and health care spending for the Inuit in Canada. PMID:23984309

  2. GMK (Progenics Pharmaceuticals).

    PubMed

    Knutson, Keith L

    2002-01-01

    Progenics Pharmaceuticals is developing GMK vaccine (a ganglioside conjugate vaccine coupled to keyhole limpet hemocyanin and formulated with the adjuvant QS-21), licensed from the Memorial Sloan-Kettering Cancer Center, for the potential treatment of melanoma and other cancers [194258], [325284]. It was previously under co-development with Bristol-Myers Squibb, but in May 2001, all rights to the GMK vaccine were returned to Progenics [409168]. It was the first of a new class of ganglioside conjugate vaccine evaluated by Progenics [194258]. GMK vaccination induces antibodies against GM2 ganglioside capable of specifically killing melanoma cells. Melanoma patients with antibodies against GM2 ganglioside have significantly improved disease-free and overall survival compared to antibody-negative subjects. The vaccine is undergoing two phase III trials, the first comparing GMK to high-dose IFNalpha in melanoma patients with more serious disease and at a high risk of relapse, and the second, in collaboration with the European Organization for Research and Treatment of Cancer, comparing GMK (14 doses of GMK over three years) to no treatment other than close monitoring of malignant melanoma patients at immediate risk of relapse [409168]. In February 1999, Lehman Brothers predicted that the vaccine had a 50% probability of reaching market, with an estimated first launch date in 2002. The analysts predicted potential peak sales in 2008 of $150 million in the US and $100 million in the rest of the world at that time [319225]. In January 2000, Lehman Brothers expected that an NDA filing would take place in 2002, with possible launch of the vaccine in 2003. In addition, Lehman Brothers estimated potential peak sales at $500 million [357788]. In August 2000, Punk, Ziegel & Company predicted that Progenics Pharmaceuticals will become sustainably profitable in 2003 following the launch of GMK and PRO-542 in 2002 [390063]. In July 2001, Ladenburg Thalmann predicted a $257 million

  3. Three Dimensional Sector Design with Optimal Number of Sectors

    NASA Technical Reports Server (NTRS)

    Xue, Min

    2010-01-01

    In the national airspace system, sectors get overloaded due to high traffic demand and inefficient airspace designs. Overloads can be eliminated in some cases by redesigning sector boundaries. This paper extends the Voronoi-based sector design method by automatically selecting the number of sectors, allowing three-dimensional partitions, and enforcing traffic pattern conformance. The method was used to design sectors at Fort-Worth and Indianapolis centers for current traffic scenarios. Results show that new designs can eliminate overloaded sectors, although not in all cases, reduce the number of necessary sectors, and conform to major traffic patterns. Overall, the new methodology produces enhanced and efficient sector designs.

  4. ENVIRONMENTAL STEWARDSHIP OF PHARMACEUTICALS ...

    EPA Pesticide Factsheets

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

  5. ENVIRONMENTAL STEWARDSHIP OF PHARMACEUTICALS ...

    EPA Pesticide Factsheets

    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 environmental pollutants (primarily in surface but also in ground waters) as a result of their widespread, continuous, combined usage in a broad range of human and veterinary therapeutic activities and practices. With respect to the risk-assessment paradigm the growing body of published work has focused primarily on the origin and occurrence of these substances. Comparatively less is known about human and ecological exposure, and even less about the documented or potential hazards associated with trace exposure to these anthropogenic substances, many of which are highly bioactive and perpetually present in many aquatic locales. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subtask 1: To integrate state-of-the-art technologies (polar organic chemical integrative samplers, advanced solid-phase extraction methodologies with liquid chromatography/electrospray/m

  6. Biricodar. Vertex Pharmaceuticals.

    PubMed

    Dey, Saibal

    2002-05-01

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

  7. OSI-774 OSI Pharmaceuticals.

    PubMed

    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].

  8. PHARMACEUTICALS AS ENVIRONMENTAL ...

    EPA Pesticide Factsheets

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

  9. PHARMACEUTICALS AS UBIQUITOUS POLLUTANTS ...

    EPA Pesticide Factsheets

    Those chemical pollutants that are regulated under various international, federal, and state programs represent but a small fraction of the universe of chemicals that occur in the environment as a result of both natural processes and human influence. Although this galaxy of targeted chemicals might be minuscule compared with the universe of both known and yet-to-be identified chemicals, an implicit assumption is that these selective lists of chemicals are responsible for the most significant share of risk with respect to environmental or economic impairment or to human health. Pharmaceuticals and personal care products (PPCPs) comprise a particularly large and diverse array of unregulated pollutants that occur in the environment from the combined activities and actions of multitudes of individuals as well as from veterinary and agricultural use. Although the concentration of any individual PPCP rarely ever exceeds the sub-ppm level (if present in drinking water, concentrations of individual PPCPs are generally less than the ppt-ppb level), evidence is accumulating that these trace-Ievel pollutants are ubiquitous, they can have a continuous presence regardless of environmental half-lives ( e.g., where sanitary wastewaters enter the environment), and the numbers of distinct and varied chemical entities could be extremely large (given that thousands are in commercial use). The research focused on in the subtasks is the development and application of state-of the-ar

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

    PubMed

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

    2016-06-25

    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.

  11. Prioritizing pharmaceuticals in municipal wastewater

    EPA Science Inventory

    Oral presentation at SETAC North America 32nd annual meeting, describing our prioritization of active pharmaceutical ingredients (APIs), based on estimates of risks posed by API residues originating from municipal wastewater. Goals of this project include prioritization of APIs f...

  12. Recognizing misleading pharmaceutical marketing online.

    PubMed

    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.

  13. [PICS: pharmaceutical inspection cooperation scheme].

    PubMed

    Morénas, J

    2009-01-01

    The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry.

  14. Actor modelling and its contribution to the development of integrative strategies for management of pharmaceuticals in drinking water.

    PubMed

    Titz, Alexandra; Döll, Petra

    2009-02-01

    Widespread presence of human pharmaceuticals in water resources across the globe is documented. While some, but certainly not enough, research on the occurrence, fate and effect of pharmaceuticals in water resources has been carried out, a holistic risk management strategy is missing. The transdisciplinary research project "start" aimed to develop an integrative strategy by the participation of experts representing key actors in the problem field "pharmaceuticals in drinking water". In this paper, we describe a novel modelling method, actor modelling with the semi-quantitative software DANA (Dynamic Actor Network Analysis), and its application in support of identifying an integrative risk management strategy. Based on the individual perceptions of different actors, the approach allows the identification of optimal strategies. Actors' perceptions were elicited by participatory model building and interviews, and were then modelled in perception graphs. Actor modelling indicated that an integrative strategy that targets environmentally-responsible prescription, therapy, and disposal of pharmaceuticals on one hand, and the development of environmentally-friendly pharmaceuticals on the other hand, will likely be most effective for reducing the occurrence of pharmaceuticals in drinking water (at least in Germany where the study was performed). However, unlike most other actors, the pharmaceutical industry itself does not perceive that the production of environmentally-friendly pharmaceuticals is an action that helps to achieve its goals, but contends that continued development of highly active pharmaceutical ingredients will help to reduce the occurrence of pharmaceuticals in the water cycle. Investment in advanced waste or drinking water treatment is opposed by both the wastewater treatment company and the drinking water supplier, and is not mentioned as appropriate by the other actors. According to our experience, actor modelling is a useful method to suggest effective

  15. Ownership of knowledge--the role of patents in pharmaceutical R&D.

    PubMed

    Correa, Carlos María

    2004-10-01

    Both the public and the private sectors contribute to research and development (R&D) in pharmaceuticals. The public sector originates many of the discoveries of new drugs. The private sector, which focuses on development, is heavily reliant on patents. Though patents are presumed to reward genuine inventions, lax rules on patentability and shortcomings in procedures permit protection to be obtained on a myriad of minor developments. These patents, though weak and possibly invalid in many cases, are used to restrain competition and delay the entry of generic competition. Developing countries should design and implement their patent laws so as to prevent strategic patenting and promote competition and access to medicines.

  16. Ownership of knowledge--the role of patents in pharmaceutical R&D.

    PubMed Central

    Correa, Carlos María

    2004-01-01

    Both the public and the private sectors contribute to research and development (R&D) in pharmaceuticals. The public sector originates many of the discoveries of new drugs. The private sector, which focuses on development, is heavily reliant on patents. Though patents are presumed to reward genuine inventions, lax rules on patentability and shortcomings in procedures permit protection to be obtained on a myriad of minor developments. These patents, though weak and possibly invalid in many cases, are used to restrain competition and delay the entry of generic competition. Developing countries should design and implement their patent laws so as to prevent strategic patenting and promote competition and access to medicines. PMID:15643801

  17. Buildings Sector Analysis

    SciTech Connect

    Hostick, Donna J.; Nicholls, Andrew K.; McDonald, Sean C.; Hollomon, Jonathan B.

    2005-08-01

    A joint NREL, ORNL, and PNNL team conducted market analysis to help inform DOE/EERE's Weatherization and Intergovernmental Program planning and management decisions. This chapter presents the results of the market analysis for the Buildings sector.

  18. Construction Sector (NAICS 23)

    EPA Pesticide Factsheets

    Find environmental regulatory information for the construction sector, including the construction of buildings or engineering projects. This includes RCRA information for hazardous waste, refrigeration compliance, asbestos, effluent guidelines & lead laws

  19. Elemental Impurities in Pharmaceutical Excipients.

    PubMed

    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 <232> 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.

  20. Availability and Perceived Value of Masters of Business Administration Degree Programs in Pharmaceutical Marketing and Management

    PubMed Central

    Clauson, Kevin A.; Latif, David A.

    2012-01-01

    Objectives. To examine pharmacist-targeted master of business administration (MBA) degree programs and investigate pharmacists’ perceptions regarding them. Methods. Specialized MBA programs in pharmaceutical marketing and management offered at US colleges and schools of pharmacy were identified in the literature and compared. Pharmacists’ perceptions of MBA programs were evaluated through a survey of clinical preceptors affiliated with a school of pharmacy. Results. Seven US universities that offer an MBA program in pharmaceutical marketing and management were identified. Thirty-three percent of the 57 pharmacist preceptors who responded to the survey reported plans to pursue an MBA degree program. Respondents preferred MBA programs related to healthcare or pharmacy (66%) over general MBA programs (33%). Conclusion. An MBA in pharmaceutical marketing and management could provide pharmacists with advanced knowledge of the operational and strategic business aspects of pharmacy practice and give pharmacy graduates an advantage in an increasingly competitive job market. PMID:22611273

  1. Marketing the use of the space environment for the processing of biological and pharmaceutical materials

    NASA Technical Reports Server (NTRS)

    1984-01-01

    The perceptions of U.S. biotechnology and pharmaceutical companies concerning the potential use of the space environment for the processing of biological substances was examined. Physical phenomena that may be important in space-base processing of biological materials are identified and discussed in the context of past and current experiment programs. The capabilities of NASA to support future research and development, and to engage in cooperative risk sharing programs with industry are discussed. Meetings were held with several biotechnology and pharmaceutical companies to provide data for an analysis of the attitudes and perceptions of these industries toward the use of the space environment. Recommendations are made for actions that might be taken by NASA to facilitate the marketing of the use of the space environment, and in particular the Space Shuttle, to the biotechnology and pharmaceutical industries.

  2. The political contradictions of incremental innovation: lessons from pharmaceutical patent examination in Brazil.

    PubMed

    Shadlen, Kenneth C

    2011-01-01

    Neodevelopmental patent regimes aim to facilitate local actors’ access to knowledge and also encourage incremental innovations. The case of pharmaceutical patent examination in Brazil illustrates political contradictions between these objectives. Brazil’s patent law includes the Ministry of Health in the examination of pharmaceutical patent applications. Though widely celebrated as a health-oriented policy, the Brazilian experience has become fraught with tensions and subject to decreasing levels of both stability and enforcement. I show how one pillar of the neodevelopmental regime, the array of initiatives to encourage incremental innovations, has fostered the acquisition of innovative capabilities in the Brazilian pharmaceutical sector, and how these new capabilities have altered actors’ policy preferences and thus contributed to the erosion of the coalition in support of the other pillar of the neodevelopmental regime, the health-oriented approach to examining pharmaceutical patents. The analysis of capability-derived preference formation points to an endogenous process of coalitional change.

  3. Human rights responsibilities of pharmaceutical companies in relation to access to medicines.

    PubMed

    Lee, Joo-Young; Hunt, Paul

    2012-01-01

    Although access to medicines is a vital feature of the right to the highest attainable standard of health ("right to health"), almost two billion people lack access to essential medicines, leading to immense avoidable suffering. While the human rights responsibility to provide access to medicines lies mainly with States, pharmaceutical companies also have human rights responsibilities in relation to access to medicines. This article provides an introduction to these responsibilities. It briefly outlines the new UN Guiding Principles on Business and Human Rights and places the human rights responsibilities of pharmaceutical companies in this context. The authors draw from the work of the first UN Special Rapporteur on the right to the highest attainable standard of health, in particular the Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines that he presented to the UN General Assembly in 2008, and his UN report on GlaxoSmithKline (GSK). While the Guiding Principles on Business and Human Rights are general human rights standards applicable to all business entities, the Human Rights Guidelines for Pharmaceutical Companies consider the specific human rights responsibilities of one sector (pharmaceutical companies) in relation to one area of activity (access to medicines). The article signals the human rights responsibilities of all pharmaceutical companies, with particular attention to patent-holding pharmaceutical companies. Adopting a right-to-health "lens," the article discusses GSK and accountability. The authors argue that human rights should shape pharmaceutical companies' policies, and provide standards in relation to which pharmaceutical companies could, and should, be held accountable. They conclude that it is now crucial to devise independent, accessible, transparent, and effective mechanisms to monitor pharmaceutical companies and hold them publicly accountable for their human rights responsibilities.

  4. [Bioequivalence studies of pharmaceutical preparations].

    PubMed

    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.

  5. Sector-scanning echocardiography

    NASA Technical Reports Server (NTRS)

    Henry, W. L.; Griffith, J. M.

    1975-01-01

    The mechanical sector scanner is described in detail, and its clinical application is discussed. Cross sectional images of the heart are obtained in real time using this system. The sector scanner has three major components: (a) hand held scanner, (b) video display, and (c) video recorder. The system provides diagnostic information in a wide spectrum of cardiac diseases, and it quantitates the severity of mitral stenosis by measurement of the mitral valve orifice area in diagnosing infants, children and adults with cyanotic congenital heart disease.

  6. Chemistry in the Pharmaceutical Industry

    NASA Astrophysics Data System (ADS)

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

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

  7. Macro trends in pharmaceutical innovation.

    PubMed

    Cohen, Fredric J

    2005-04-01

    Extract: A lately recycled criticism of the pharmaceutical industry is that it is failing in its mission to innovate. In particular, critics question the industry's incentives to innovate, and they deride those innovations the industry makes as imitative. Industry advocates contend the opposite. The truth is that there are no generally accepted measures of innovation that would conclusively prove either side's point. However, I have found trends in several measures that support both sides of the innovation debate. Overall, the bulk of evidence suggests that the pharmaceutical industry continues to regard pioneering innovations as important (evidenced by the motivation, effort and ability of the industry to create such innovations). However, like other mature manufacturing industries, the pharmaceutical industry relies heavily on incremental innovations (what critics call "me-too" drugs) to sustain its profits. To a large extent, these incremental innovations are themselves medically beneficial and should be encouraged rather than dismissed as merely imitative.

  8. Planning and coordinating pharmaceutical purchasing.

    PubMed

    Buchanan, E C

    1984-09-01

    The planning and coordination of the pharmaceutical purchasing process are discussed. Planning for pharmaceutical purchasing should begin with decisions regarding why a purchasing policy is needed, what the institution's purchasing policy will be, and what departments will be involved in purchasing. General goals of purchasing and procedures for revising purchasing functions are presented, and the role of the pharmacy department, materials management, and other hospital departments in purchasing is discussed. Coordinating input on purchasing decisions from medical staff, administration, and clinical and technical pharmacy personnel to achieve purchasing goals and objectives is discussed. A well-designed pharmaceutical purchasing system provides for planned and scheduled purchases, competitive bidding, product standardization, group purchasing, information sharing, internal accountability, and quality assurance.

  9. Misperceptions of peer pill-popping: the prevalence, correlates, and effects of inaccurate assumptions about peer pharmaceutical misuse.

    PubMed

    Sanders, Amber; Stogner, John; Seibert, Jonathan; Miller, Bryan Lee

    2014-06-01

    Peer behaviors may significantly influence personal behavior yet individuals may not accurately estimate their peers' actions. Overestimations of peer substance use may encourage initiation or exacerbate extant problems. The present study examines misperceptions of peer pharmaceutical misuse and explores the relationship between reported misuse and perceptions of misuse for four categories of prescription drugs. Data collected from 2,349 college students in the Southeastern United States were analyzed and results indicated that overall perceptions of misuse were significantly higher than actual misuse. These findings suggest that intervention efforts may benefit from addressing misperceptions of pharmaceutical misuse. Study limitations and implications are addressed.

  10. 21 CFR 26.17 - Role and composition of the Joint Sectoral Committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Role and composition of the Joint Sectoral Committee. 26.17 Section 26.17 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL...

  11. 21 CFR 26.47 - Role and composition of the Joint Sectoral Committee.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Role and composition of the Joint Sectoral Committee. 26.47 Section 26.47 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL...

  12. 21 CFR 26.47 - Role and composition of the Joint Sectoral Committee.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Role and composition of the Joint Sectoral Committee. 26.47 Section 26.47 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL...

  13. 76 FR 41266 - Critical Path Manufacturing Sector Research Initiative (U01)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-13

    ... HUMAN SERVICES Food and Drug Administration Critical Path Manufacturing Sector Research Initiative (U01) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... research in a way that can improve reliability of pharmaceutical product manufacturing and quality...

  14. 21 CFR 26.47 - Role and composition of the Joint Sectoral Committee.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Role and composition of the Joint Sectoral Committee. 26.47 Section 26.47 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL...

  15. Methods of Rapid Microbiological Assay and Their Application to Pharmaceutical and Medical Device Fabrication.

    PubMed

    Shintani, Hideharu

    2016-01-01

     There are several rapid microbiological methods becoming available that have useful applications in pharmaceutical and medical devices. They are ATP bioluminescence, fluorescent labeling, electrical resistance, and nucleic acid probes. In choosing to employ rapid methods, the microbiologist should examine their prospective performances against the specific requirements for that sector. Some methods may require expensive equipment and offer full automation, and others represent only a small investment. The regulatory view of these methods is changing and they still officially have not been approved in medical and pharmaceutical area, but it will still be up to the microbiologist to demonstrate that the method chosen is fit for the purpose intended.

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

    PubMed

    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.

  17. Endocrine-Active Pharmaceuticals: An Environmental Concern?

    EPA Science Inventory

    Recently, there has been growing interest in pharmaceuticals that are specifically designed to have endocrine activity, such as the estrogens used in birth control pills, exerting unintended effects on fish and other aquatic organisms. These pharmaceuticals may not be persistent...

  18. Pharmaceutical Research and Manufacturers of America

    MedlinePlus

    ... The New Era of Medicine SHARE THIS The Pharmaceutical Research and Manufacturers of America, PhRMA, represents the ... PhRMA Privacy Policy Terms of Service Site Map Pharmaceutical Research and Manufacturers of America® 950 F Street, ...

  19. Modeling picking on pharmaceutical tablets

    NASA Astrophysics Data System (ADS)

    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.).

  20. Financing pharmaceuticals in transition economies.

    PubMed

    Kanavos, P

    1999-06-01

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

  1. Pharmaceutical care in smoking cessation

    PubMed Central

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

    2015-01-01

    As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients’ access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre–post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy’s smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. PMID:25678779

  2. Immunotoxicology in the pharmaceutical industry.

    PubMed Central

    Norbury, K C

    1982-01-01

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

  3. Patrick Couvreur: inspiring pharmaceutical innovation.

    PubMed

    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.

  4. Changing Perceptions

    ERIC Educational Resources Information Center

    Mallett, Susanne; Wren, Steve; Dawes, Mark; Blinco, Amy; Haines, Brett; Everton, Jenny; Morgan, Ellen; Barton, Craig; Breen, Debbie; Ellison, Geraldine; Burgess, Danny; Stavrou, Jim; Carre, Catherine; Watson, Fran; Cherry, David; Hawkins, Chris; Stapenhill-Hunt, Maria; Gilderdale, Charlie; Kiddle, Alison; Piggott, Jennifer

    2009-01-01

    A group of teachers involved in embedding NRICH tasks (http://nrich.maths.org) into their everyday practice were keen to challenge common perceptions of mathematics, and of the teaching and learning of mathematics. In this article, the teachers share what they are doing to change these perceptions in their schools.

  5. Machine perception

    SciTech Connect

    Not Available

    1982-01-01

    The book is aimed at the level of a graduate student or the practising professional and discusses visual perception by computers. Topics covered include: pattern classification methods; polyhedra scenes; shape analysis and recognition; perception of brightness and colour; edge and curve detection; region segmentation; texture analysis; depth measurement analysis; knowledge-based systems and applications. A subject index is included.

  6. The Effect of Active Learning Methodologies on the Teaching of Pharmaceutical Care in a Brazilian Pharmacy Faculty

    PubMed Central

    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. Sector Study Guideline

    DTIC Science & Technology

    1990-03-01

    LIMITS . . . . . . . . 8 5.1 Market Groups . ................ 8 5.2 Market Group A and the Level of Effort (LOE) Assessment...9 5.3 Market Groups B and Level of Effort (LOE) Assessment . . . . . . . . . 10 5.4 Market Group C and the Level of Effort Assessment 11 5.5... Market Groups Al, B1, C1 versus A2, B2, C2 (LOE) 11 6.0 AVAILABILITY OF INFORMATION . . . . . . . . . . . . . 12 7.0 OVERVIEW OF THE PROPOSED SECTOR

  8. Social Work-Business Sector Collaboration in Pursuit of Economic Justice.

    PubMed

    Lee, Wonhyung

    2016-07-01

    This article examines social workers' perceptions, experiences, and prospects regarding working in the business sector after participating in an MSW field practicum with a local microlending program. Social workers' insights suggest that cross-sector collaboration leads to vast opportunities not only for the populations served by the collaborative efforts, but also for social work as a profession. However, several challenges are evealed, including social workers' unfamiliarity with business operations, the business sector's narrow understanding of social workers' roles, and divisions between participants in interprofessional collaboration. This article calls for enhancing the role of social work to maximize its impact on economic development through further research and tangible cross-sector projects.

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

    PubMed

    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

  10. Consumer-perceived risks and choices about pharmaceuticals in the environment: a cross-sectional study

    PubMed Central

    2013-01-01

    Background There is increasing concern that pollution from pharmaceuticals used in human medicine and agriculture can be a threat to the environment. Little is known, however, if people are aware that pharmaceuticals may have a detrimental influence on the environment. The present study examines people’s risk perception and choices in regard to environmental risks of pharmaceuticals used in human medicine and for agricultural purposes. Methods A representative sample of the U.S. population (N = 640) was surveyed. Respondents completed a hypothetical choice task that involved tradeoffs between human and environmental health. In addition, it was examined how much people would support an environment policy related to drug regulation. Results For agricultural pharmaceuticals, respondents reported a high level of satisfaction for a policy requiring farms to limit their use of antibiotics. In the domain of pharmaceuticals used in human medicine, we found that people were willing to consider environmental consequences when choosing a drug, but only when choices were made about treatment options for a rather harmless disease. In contrast, when decisions were made about treatment options for a severe disease, the drug’s effectiveness was the most important criterion. Conclusions It can be concluded that the environmental impact of a drug will be hardly considered in decisions about pharmaceuticals for severe diseases like cancer, and this may be due to the fact that these decisions are predominantly affective in nature. However, for less severe health risks, people are willing to balance health and environmental considerations. PMID:23734758

  11. Students' Perception of University Teaching Behaviours

    ERIC Educational Resources Information Center

    Ali, Akhtar; Tariq, Riaz H.; Topping, J.

    2009-01-01

    The purpose of the paper is to explore students' perception of university teaching behaviours in Pakistan. Three hundred and fifty students from the six public sector Pakistani universities returned questionnaires. Assessment framework, learning activities and instructional strategies emerged from factor analysis as common factors. Students' views…

  12. Public policy and pharmaceutical innovation.

    PubMed

    Grabowski, H G

    1982-09-01

    Historically, new drug introductions have played a central role in medical progress and the availability of cost-effective therapies. Nevertheless, public policy toward pharmaceuticals has been characterized in recent times by increasingly stringent regulatory controls, shorter effective patent terms, and increased encouragement of generic product usage. This has had an adverse effect on the incentives and capabilities of firms to undertake new drug research and development activity. The industry has experienced sharply rising research and development costs, declining annual new drug introductions, and fewer independent sources of drug development. This paper considers the effects of government regulatory policies on the pharmaceutical innovation process from several related perspectives. It also examines the merits of current public policy proposals designed to stimulate drug innovation including patent restoration and various regulatory reform measures.

  13. Public Policy and Pharmaceutical Innovation

    PubMed Central

    Grabowski, Henry G.

    1982-01-01

    Historically, new drug introductions have played a central role in medical progress and the availability of cost-effective therapies. Nevertheless, public policy toward pharmaceuticals has been characterized in recent times by increasingly stringent regulatory controls, shorter effective patent terms, and increased encouragement of generic product usage. This has had an adverse effect on the incentives and capabilities of firms to undertake new drug research and development activity. The industry has experienced sharply rising research and development costs, declining annual new drug introductions, and fewer independent sources of drug development. This paper considers the effects of government regulatory policies on the pharmaceutical innovation process from several related perspectives. It also examines the merits of current public policy proposals designed to stimulate drug innovation including patent restoration and various regulatory reform measures. PMID:10309721

  14. Biosafe Nanoscale Pharmaceutical Adjuvant Materials

    PubMed Central

    Jin, Shubin; Li, Shengliang; Wang, Chongxi; Liu, Juan; Yang, Xiaolong; Wang, Paul C.; Zhang, Xin; Liang, Xing-Jie

    2014-01-01

    Thanks to developments in the field of nanotechnology over the past decades, more and more biosafe nanoscale materials have become available for use as pharmaceutical adjuvants in medical research. Nanomaterials possess unique properties which could be employed to develop drug carriers with longer circulation time, higher loading capacity, better stability in physiological conditions, controlled drug release, and targeted drug delivery. In this review article, we will review recent progress in the application of representative organic, inorganic and hybrid biosafe nanoscale materials in pharmaceutical research, especially focusing on nanomaterial-based novel drug delivery systems. In addition, we briefly discuss the advantages and notable functions that make these nanomaterials suitable for the design of new medicines; the biosafety of each material discussed in this article is also highlighted to provide a comprehensive understanding of their adjuvant attributes. PMID:25429253

  15. Examining pharmaceuticals using terahertz spectroscopy

    NASA Astrophysics Data System (ADS)

    Sulovská, Kateřina; Křesálek, Vojtěch

    2015-10-01

    Pharmaceutical trafficking is common issue in countries where they are under stricter dispensing regime with monitoring of users. Most commonly smuggled pharmaceuticals include trade names Paralen Plus, Modafen, Clarinase repetabs, Aspirin complex, etc. These are transported mainly from Eastern Europe (e.g. Poland, Ukraine, Russia) to countries like Czech Republic, which is said to have one of the highest number of methamphetamine producers in Europe. The aim of this paper is to describe the possibility of terahertz spectroscopy utilization as an examining tool to distinguish between pharmaceuticals containing pseudoephedrine compounds and those without it. Selected medicaments for experimental part contain as an active ingredient pseudoephedrine hydrochloride or pseudoephedrine sulphate. Results show a possibility to find a pseudoephedrine compound spectra in samples according to previously computed and experimentally found ones, and point out that spectra of same brand names pills may vary according to their expiration date, batch, and amount of absorbed water vapours from ambience. Mislead spectrum also occurs during experimental work in a sample without chosen active ingredient, which shows persistent minor inconveniences of terahertz spectroscopy. All measurement were done on the TPS Spectra 3000 instrument.

  16. [E-commerce of pharmaceuticals].

    PubMed

    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.

  17. Understanding pharmaceutical quality by design.

    PubMed

    Yu, Lawrence X; Amidon, Gregory; Khan, Mansoor A; Hoag, Stephen W; Polli, James; Raju, G K; Woodcock, Janet

    2014-07-01

    This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review.

  18. Stability of Pharmaceuticals in Space

    NASA Technical Reports Server (NTRS)

    Nguyen, Y-Uyen

    2009-01-01

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

  19. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    EPA Pesticide Factsheets

    Modern sanitary practices result in large volumes of human waste, as well as domestic and industrial sewage, being collected and treated at common collection points, wastewater treatment plants (WWTP). In recognition of the growing use of sewage sludges as a fertilizers and as soilamendments, and the scarcity of current data regarding the chemical constituents in sewage sludges, the United States National Research Council (NRC) in 2002 produced a report on sewage sludges. Among the NRC's recommendations was the need for investigating the occurrence of pharmaceuticals and personal care products (PPCPs) in sewage sludges. PPCPsare a diverse array of non-regulated contaminants that had not been studied in previous sewage sludges surveys but which are likely to be present. The focus of this paper will be to review the current analytical methodologies available for investigating whether pharmaceuticals are present in WWTP-produced sewage sludges, to summarize current regulatory practices regarding sewage sludges, and to report on the presence of pharmaceuticals in sewage sludges. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subta

  20. Relevance of variation in use of terminology to define generic pharmaceutical products.

    PubMed

    Fonseca, Elize Massard da

    2015-02-01

    The World Health Organization (WHO) promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country) and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies.

  1. Pitch perception.

    PubMed

    Yost, William A

    2009-11-01

    This article is a review of the psychophysical study of pitch perception. The history of the study of pitch has seen a continual competition between spectral and temporal theories of pitch perception. The pitch of complex stimuli is likely based on the temporal regularities in a sound's waveform, with the strongest pitches occurring for stimuli with low-frequency components. Thus, temporal models, especially those based on autocorrelation-like processes, appear to account for the majority of the data.

  2. Nanotechnology and its applications in the food sector.

    PubMed

    Sozer, Nesli; Kokini, Jozef L

    2009-02-01

    Nanoscience and nanotechnology are new frontiers of this century. Their applications to the agriculture and food sector are relatively recent compared with their use in drug delivery and pharmaceuticals. Smart delivery of nutrients, bioseparation of proteins, rapid sampling of biological and chemical contaminants and nanoencapsulation of nutraceuticals are some of the emerging topics of nanotechnology for food and agriculture. Advances in technologies, such as DNA microarrays, microelectromechanical systems and microfluidics, will enable the realization of the potential of nanotechnology for food applications. In this review, we intended to summarize the applications of nanotechnology relevant to food and nutraceuticals together with identifying the outstanding challenges.

  3. A course in constructing effective displays of data for pharmaceutical research personnel.

    PubMed

    Bradstreet, Thomas E; Nessly, Michael L; Short, Thomas H

    2013-01-01

    Interpreting data and communicating effectively through graphs and tables are requisite skills for statisticians and non-statisticians in the pharmaceutical industry. However, the quality of visual displays of data in the medical and pharmaceutical literature and at scientific conferences is severely lacking. We describe an interactive, workshop-driven, 2-day short course that we constructed for pharmaceutical research personnel to learn these skills. The examples in the course and the workshop datasets source from our professional experiences, the scientific literature, and the mass media. During the course, the participants are exposed to and gain hands-on experience with the principles of visual and graphical perception, design, and construction of both graphic and tabular displays of quantitative and qualitative information. After completing the course, with a critical eye, the participants are able to construct, revise, critique, and interpret graphic and tabular displays according to an extensive set of guidelines.

  4. Transitioning to a national health system in Cyprus: a stakeholder analysis of pharmaceutical policy reform

    PubMed Central

    Kanavos, Panos G

    2015-01-01

    Abstract Objective To review the pharmaceutical sector in Cyprus in terms of the availability and affordability of medicines and to explore pharmaceutical policy options for the national health system finance reform expected to be introduced in 2016. Methods We conducted semi-structured interviews in April 2014 with senior representatives from seven key national organizations involved in pharmaceutical care. The captured data were coded and analysed using the predetermined themes of pricing, reimbursement, prescribing, dispensing and cost sharing. We also examined secondary data provided by the Cypriot Ministry of Health; these data included the prices and volumes of prescription medicines in 2013. Findings We identified several key issues, including high medicine prices, underuse of generic medicines and high out-of-pocket drug spending. Most stakeholders recommended that the national government review existing pricing policies to ensure medicines within the forthcoming national health system are affordable and available, introduce a national reimbursement system and incentivize the prescribing and dispensing of generic medicines. There were disagreements over how to (i) allocate responsibilities to governmental agencies in the national health system, (ii) reconcile differences in opinion between stakeholders and (iii) raise awareness among patients, physicians and pharmacists about the benefits of greater generic drug use. Conclusion In Cyprus, if the national health system is going to provide universal health coverage in a sustainable fashion, then the national government must address the current issues in the pharmaceutical sector. Importantly, the country will need to increase the market share of generic medicines to contain drug spending. PMID:26478624

  5. Chiral Dark Sector

    NASA Astrophysics Data System (ADS)

    Co, Raymond T.; Harigaya, Keisuke; Nomura, Yasunori

    2017-03-01

    We present a simple and natural dark sector model in which dark matter particles arise as composite states of hidden strong dynamics and their stability is ensured by accidental symmetries. The model has only a few free parameters. In particular, the gauge symmetry of the model forbids the masses of dark quarks, and the confinement scale of the dynamics provides the unique mass scale of the model. The gauge group contains an Abelian symmetry U (1 )D , which couples the dark and standard model sectors through kinetic mixing. This model, despite its simple structure, has rich and distinctive phenomenology. In the case where the dark pion becomes massive due to U (1 )D quantum corrections, direct and indirect detection experiments can probe thermal relic dark matter which is generically a mixture of the dark pion and the dark baryon, and the Large Hadron Collider can discover the U (1 )D gauge boson. Alternatively, if the dark pion stays light due to a specific U (1 )D charge assignment of the dark quarks, then the dark pion constitutes dark radiation. The signal of this radiation is highly correlated with that of dark baryons in dark matter direct detection.

  6. Consumer Perceptions of Sponsors of Disease Awareness Advertising

    ERIC Educational Resources Information Center

    Hall, Danika V.; Jones, Sandra C.; Iverson, Donald C.

    2011-01-01

    Purpose: In many countries there is emerging concern regarding alliances between the pharmaceutical industry and health non-profit organizations (NPOs), and the increase of co-sponsored marketing activities such as disease awareness advertising. The current study aims to explore Australian women's perceptions of disease awareness advertising with…

  7. The Use of Animated Videos to Illustrate Oral Solid Dosage Form Manufacturing in a Pharmaceutics Course

    PubMed Central

    Roberson, Charles

    2016-01-01

    Objective. To evaluate the impact of animated videos of oral solid dosage form manufacturing as visual instructional aids on pharmacy students’ perception and learning. Design. Data were obtained using a validated, paper-based survey instrument designed to evaluate the effectiveness, appeal, and efficiency of the animated videos in a pharmaceutics course offered in spring 2014 and 2015. Basic demographic data were also collected and analyzed. Assessment data at the end of pharmaceutics course was collected for 2013 and compared with assessment data from 2014, and 2015. Assessment. Seventy-six percent of the respondents supported the idea of incorporating animated videos as instructional aids for teaching pharmaceutics. Students’ performance on the formative assessment in 2014 and 2015 improved significantly compared to the performance of students in 2013 whose lectures did not include animated videos as instructional aids. Conclusions. Implementing animated videos of oral solid dosage form manufacturing as instructional aids resulted in improved student learning and favorable student perceptions about the instructional approach. Therefore, use of animated videos can be incorporated in pharmaceutics teaching to enhance visual learning. PMID:27899837

  8. Introduction: Institutional corruption and the pharmaceutical policy.

    PubMed

    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.

  9. The sun's magnetic sector structure

    NASA Technical Reports Server (NTRS)

    Svalgaard, L.; Wilcox, J. M.; Scherrer, P. H.; Howard, R.

    1975-01-01

    The synoptic appearance of solar magnetic sectors is studied using 454 sector boundaries observed at earth during 1959-1973. The sectors are clearly visible in the photospheric magnetic field. Sector boundaries can be clearly identified as north-south running demarcation lines between regions of persistent magnetic polarity imbalances. These regions extend up to about 35 deg of latitude on both sides of the equator. They generally do not extend into the polar caps. The polar cap boundary can be identified as an east-west demarcation line marking the poleward limit of the sectors. The typical flux imbalance for a magnetic sector is about 4 x 10 to the 21st power Maxwells.

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

    EPA Science Inventory

    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...

  11. Energy Sector Market Analysis

    SciTech Connect

    Arent, D.; Benioff, R.; Mosey, G.; Bird, L.; Brown, J.; Brown, E.; Vimmerstedt, L.; Aabakken, J.; Parks, K.; Lapsa, M.; Davis, S.; Olszewski, M.; Cox, D.; McElhaney, K.; Hadley, S.; Hostick, D.; Nicholls, A.; McDonald, S.; Holloman, B.

    2006-10-01

    This paper presents the results of energy market analysis sponsored by the Department of Energy's (DOE) Weatherization and International Program (WIP) within the Office of Energy Efficiency and Renewable Energy (EERE). The analysis was conducted by a team of DOE laboratory experts from the National Renewable Energy Laboratory (NREL), Oak Ridge National Laboratory (ORNL), and Pacific Northwest National Laboratory (PNNL), with additional input from Lawrence Berkeley National Laboratory (LBNL). The analysis was structured to identify those markets and niches where government can create the biggest impact by informing management decisions in the private and public sectors. The analysis identifies those markets and niches where opportunities exist for increasing energy efficiency and renewable energy use.

  12. Exploring Oman's Energy Sector

    NASA Astrophysics Data System (ADS)

    Al-Saqlawi, Juman; Madani, Kaveh; Mac Dowell, Niall

    2016-04-01

    Located in a region where over 40% of the world's oil and gas reserves lie and in a trend similar to that of its neighbors, Oman's economy has been reliant on crude oil export since the 1970's. Being aware of the dangers of this reliance along with the discovery of Natural Gas since the 1980s, the Omani government's policy of diversifying its economy has shifted its reliance on Oil to another fossil fuel, namely Natural Gas. Given that energy is the lifeline of Oman's economy, effective and efficient forward planning and policy development is essential for the country's current and future economic development. This presentation explores the current status of the energy sector in Oman from home production and import to eventual final uses. The presentation highlights the major issues with Oman's current energy policies and suggests various strategies that could be adopted by Oman for a more efficient and sustainable future.

  13. Pharmaceuticals and Controlled Substances and Demolition

    EPA Pesticide Factsheets

    Pharmaceuticals and controlled substances found during residential demolition, such as prescription medications or illegal drugs, may require special treatment for disposal or recycling before demolition.

  14. Agenda for an anthropology of pharmaceutical practice.

    PubMed

    Nichter, M; Vuckovic, N

    1994-12-01

    Over the last two decades, patterns of pharmaceutical-related behavior and the cultural interpretation of medicines have been examined by anthropologists in several cultural settings. In this paper the authors identify additional issues warranting study so as to broaden the scope of pharmaceutical anthropology, utilizing as a unifying focus the examination of pharmaceutical use in the context of social transformation. Ten interactive themes are presented which bridge micro-level and macro-level investigations of pharmaceutical use. The discussion moves from the discourse on 'rational drug use' to the rationales which underscore drug prescription, manufacture, and demand.

  15. Uncertainty bounds using sector theory

    NASA Technical Reports Server (NTRS)

    Waszak, Martin R.; Schmidt, David K.

    1989-01-01

    An approach based on sector-stability theory can furnish a description of the uncertainty associated with the frequency response of a model, given sector-bounds on the individual parameters of the model. The application of the sector-based approach to the formulation of useful uncertainty descriptions for linear, time-invariant multivariable systems is presently explored, and the approach is applied to two generic forms of parameter uncertainty in order to investigate its advantages and limitations. The results obtained show that sector-uncertainty bounds can be used to evaluate the impact of parameter uncertainties on the frequency response of the design model.

  16. Plant cells as pharmaceutical factories.

    PubMed

    Rischer, Heiko; Häkkinen, Suvi T; Ritala, Anneli; Seppänen-Laakso, Tuulikki; Miralpeix, Bruna; Capell, Teresa; Christou, Paul; Oksman-Caldentey, Kirsi-Marja

    2013-01-01

    Molecules derived from plants make up a sizeable proportion of the drugs currently available on the market. These include a number of secondary metabolite compounds the monetary value of which is very high. New pharmaceuticals often originate in nature. Approximately 50% of new drug entities against cancer or microbial infections are derived from plants or micro-organisms. However, these compounds are structurally often too complex to be economically manufactured by chemical synthesis, and frequently isolation from naturally grown or cultivated plants is not a sustainable option. Therefore the biotechnological production of high-value plant secondary metabolites in cultivated cells is potentially an attractive alternative. Compared to microbial systems eukaryotic organisms such as plants are far more complex, and our understanding of the metabolic pathways in plants and their regulation at the systems level has been rather poor until recently. However, metabolic engineering including advanced multigene transformation techniques and state-of-art metabolomics platforms has given us entirely new tools to exploit plants as Green Factories. Single step engineering may be successful on occasion but in complex pathways, intermediate gene interventions most often do not affect the end product accumulation. In this review we discuss recent developments towards elucidation of complex plant biosynthetic pathways and the production of a number of highvalue pharmaceuticals including paclitaxel, tropane, morphine and terpenoid indole alkaloids in plants and cell cultures.

  17. PHARMACEUTICALS IN THE ENVIRONMENT: SOURCES ...

    EPA Pesticide Factsheets

    An issue that began to receive more attention by environmental scientists in the late 1990s was the conveyancy of pharmaceuticals in the environment by way of their use in human and veterinary medical practices and personal care The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subtask 1: To integrate state-of-the-art technologies (polar organic chemical integrative samplers, advanced solid-phase extraction methodologies with liquid chromatography/electrospray/mass spectrometry) and apply them to studying the sources and fate of a select list of PPCPs. Application and improvement of analytical methodologies that can detect non-volatile, polar, water-soluble pharmaceuticals in source waters at levels that could be environmentally significant (at concentrations less than parts per billion, ppb). IAG with USGS ends in FY05. APM 20 due in FY05.Subtask 2: Coordination of interagency research and public outreach activities for PPCPs. Participate on NSTC Health and Environment subcommittee working group on PPCPs. Web site maintenance and expansion, invited technical presentations, invited articles for peer-reviewed journals, intervi

  18. ABSTRACT PRESENTATION--PHARMACEUTICALS AS ...

    EPA Pesticide Factsheets

    Pharmaceuticals comprise a large and diverse array of contaminants that can occur in the environmentfrom the combined activities and actions of multitudes of individuals as well as from veterinary andagricultural use. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subtask 1: To integrate state-of-the-art technologies (polar organic chemical integrative samplers, advanced solid-phase extraction methodologies with liquid chromatography/electrospray/mass spectrometry) and apply them to studying the sources and fate of a select list of PPCPs. Application and improvement of analytical methodologies that can detect non-volatile, polar, water-soluble pharmaceuticals in source waters at levels that could be environmentally significant (at concentrations less than parts per billion, ppb). IAG with USGS ends in FY05. APM 20 due in FY05.Subtask 2: Coordination of interagency research and public outreach activities for PPCPs. Participate on NSTC Health and Environment subcommittee working group on PPCPs. Web site maintenance and expansion, invited technical presentations, invited articles for peer-reviewed journals, interviews for med

  19. An examination of pharmaceutical systems in severely disrupted countries

    PubMed Central

    2012-01-01

    This research assesses informal markets that dominate pharmaceutical systems in severely disrupted countries and identifies areas for further investigation. Findings are based on recent academic papers, policy and grey literature, and field studies in Somalia, Afghanistan, the Democratic Republic of Congo and Haiti. The public sector in the studied countries is characterized in part by weak Ministries of Health and low donor coordination. Informal markets, where medicines are regularly sold in market stalls and unregulated pharmacies, often accompanied by unqualified medical advice, have proliferated. Counterfeit and sub-standard medicines trade networks have also developed. To help increase medicine availability for citizens, informal markets should be integrated into existing access to medicines initiatives. PMID:23217184

  20. Exposure of medical students to pharmaceutical marketing in primary care settings: frequent and influential.

    PubMed

    Sarikaya, Ozlem; Civaner, Murat; Vatansever, Kevser

    2009-12-01

    It is known that interaction between pharmaceutical companies and medical professionals may lead to corruption of professional values, irrational use of medicine, and negative effects on the patient-physician relationship. Medical students frequently interact with pharmaceutical company representatives and increasingly accept their gifts. Considering the move toward early clinical encounters and community-based education, which expose students early to pharmaceutical representatives, the influence of those gifts is becoming a matter of concern. This study examines the frequency and influence of student exposure to drug marketing in primary care settings, as well as student perceptions of physician-pharmaceutical company relationships. This was a two-phase study consisting of qualitative research followed by a cross-sectional survey. Clinical experience logbooks of 280 second-year students in one school were analysed, and the themes that emerged were used to develop a survey that was administered to 308 third-year students from two medical schools. Survey results showed a 91.2% exposure to any type of marketing, and 56.8% of students were exposed to all classes of marketing methods studied. Deliberate targeting of students by pharmaceutical representatives, in particular, was correlated with being less sensitive to the negative effects of and having positive opinions about interactions with pharmaceutical companies. The vast majority of students are exposed to drug marketing in primary care settings, and may become more vulnerable to that strategy. Considering that medical students are vulnerable and are targeted deliberately by pharmaceutical companies, interventions aimed at developing skills in the rational use of medicines and in strategies for coping with drug marketing should be devised.

  1. The shaping of pharmaceutical governance: the Israeli case

    PubMed Central

    2014-01-01

    This article focuses on governance of the pharmaceutical sector in Israel. It traces the relationships between the state, industry, and sick funds from before the establishment of National Health Insurance (NHI) in 1995 to the beginning of this decade, in particular as they have grappled with the challenge of making national formulary decisions in a rational manner. Subsequent to the introduction of NHI there have been shifts in the modes and mix of governance. This research shows empirically that a relatively complex mix of hierarchical and network modes of governance can be successfully established over an extended period of time when flexibility is maintained through the implementation process. The system for defining and updating a standard basket of health services has coped well with the challenge of managing a range of difficult and potentially volatile stakeholder relationships in the pharmaceutical sector and of distancing ministers from controversies of funding and listing decisions. Government has succeeded in containing drug costs whilst still maintaining a basket of reimbursable drugs that, from an international perspective, is comprehensive and technologically advanced. On the other hand, network arrangements appear to have delayed the introduction of suitable accountability relationships and hindered their development. The state has traditionally played an intermediary role between unavoidable corporate interests of industry and sick funds, with little transparency and to the detriment of more pluralistic access to decision making. Governance arrangements in Israel appear to limit the potential and incentive of the state and the sick funds to realize their potential countervailing powers in subsidy and pricing decisions. PMID:24914409

  2. The shaping of pharmaceutical governance: the Israeli case.

    PubMed

    Sax, Philip

    2014-01-01

    This article focuses on governance of the pharmaceutical sector in Israel. It traces the relationships between the state, industry, and sick funds from before the establishment of National Health Insurance (NHI) in 1995 to the beginning of this decade, in particular as they have grappled with the challenge of making national formulary decisions in a rational manner. Subsequent to the introduction of NHI there have been shifts in the modes and mix of governance. This research shows empirically that a relatively complex mix of hierarchical and network modes of governance can be successfully established over an extended period of time when flexibility is maintained through the implementation process. The system for defining and updating a standard basket of health services has coped well with the challenge of managing a range of difficult and potentially volatile stakeholder relationships in the pharmaceutical sector and of distancing ministers from controversies of funding and listing decisions. Government has succeeded in containing drug costs whilst still maintaining a basket of reimbursable drugs that, from an international perspective, is comprehensive and technologically advanced. On the other hand, network arrangements appear to have delayed the introduction of suitable accountability relationships and hindered their development. The state has traditionally played an intermediary role between unavoidable corporate interests of industry and sick funds, with little transparency and to the detriment of more pluralistic access to decision making. Governance arrangements in Israel appear to limit the potential and incentive of the state and the sick funds to realize their potential countervailing powers in subsidy and pricing decisions.

  3. Nanoparticulate carriers (NPC) for oral pharmaceutics and nutraceutics.

    PubMed

    Lopes, C M; Martins-Lopes, P; Souto, E B

    2010-02-01

    The introduction of nanoparticulate carriers (NPC) in the pharmaceutic and nutraceutic fields has changed the definitions of disease management and treatment, diagnosis, as well as the supply food chain in the agri-food sector. NPC composed of synthetic polymers, proteins or polysaccharides gather interesting properties to be used for oral administration of pharmaceutics and nutraceutics. Oral administration remains the most convenient way of delivering drugs (e.g. peptides, proteins and nucleic acids) since these suffer similar metabolic pathways as food supply. Recent advances in biotechnology have produced highly potent new molecules however with low oral bioavailability. A suitable and promising approach to overcome their sensitivity to chemical and enzymatic hydrolysis as well as the poor cellular uptake, would be their entrapment within suitable gastrointestinal (GI) resistant NPC. Increasing attention has been paid to the potential use of NPC for peptides, proteins, antioxidants (carotenoids, omega fatty acids, coenzyme Q10), vitamins, probiotics, for oral administration. This review focuses on the most important materials to produce NPC for oral administration, and the most recent achievements in the production techniques and bioactives successfully delivered by these means.

  4. Partnership in Sector Wide Approaches

    ERIC Educational Resources Information Center

    Tolley, Hilary

    2011-01-01

    Within the context of bilateral support to the education sector in Tonga and the Solomon Islands, this paper will explore how the discourse of "partnership" has been interpreted and activated within the Sector wide approach (SWAp). In concentrating particularly on the relationship between the respective Ministries of Education and New…

  5. Synthetic biology advances for pharmaceutical production

    PubMed Central

    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

  6. Potential bias in ophthalmic pharmaceutical clinical trials

    PubMed Central

    Varner, Paul

    2008-01-01

    To make clinicians aware of potential sources of error in ophthalmic pharmaceutical clinical trials that can lead to erroneous interpretation of results, a critical review of the study design of various pharmaceutical ophthalmic clinical trials was completed. Discrepancies as a result of study shortcomings may explain observed differences between reported ophthalmic trial data and observed clinical results. PMID:19668731

  7. Nanostructured materials in electroanalysis of pharmaceuticals.

    PubMed

    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.

  8. Pharmaceutical experiment aboard STS-67 mission

    NASA Technical Reports Server (NTRS)

    1995-01-01

    Astronaut William G. Gregory, pilot, works with a pharmaceutical experiment on the middeck of the Earth-orbiting Space Shuttle Endeavour during the STS-67 mission. Commercial Materials Dispersion Apparatus Instruments Technology Associates Experiments (CMIX-03) includes not only pharmaceutical, but also biotechnology, cell biology, fluids, and crystal growth investigation

  9. The Impact of Biotechnology on Pharmaceutics.

    ERIC Educational Resources Information Center

    Block, Lawrence H.

    1990-01-01

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

  10. Synthetic biology advances for pharmaceutical production.

    PubMed

    Breitling, Rainer; Takano, Eriko

    2015-12-01

    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.

  11. Pharmaceutical counterfeiting and the RFID technology intervention.

    PubMed

    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.

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

    PubMed

    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

  13. 50 CFR 648.87 - Sector allocation.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Fixed Gear Sector, as defined in § 648.87(d)(1) or (2), joins a new sector, or fishes pursuant to the... in a sector may only fish in a particular stock area, as specified in paragraphs (b)(1)(ii)(A... that sector to fish under the provisions of the common pool or in another sector in the year...

  14. Marine-Derived Bioactive Peptides for Biomedical Sectors: A Review.

    PubMed

    Ruiz-Ruiz, Federico; Mancera-Andrade, Elena I; Iqbal, Hafiz M N

    2017-01-01

    Marine-based resources such as algae and other marine by-products have been recognized as rich sources of structurally diverse bioactive peptides. Evidently, their structural characteristics including unique amino acid residues are responsible for their biological activity. Several of the above-mentioned marine-origin species show multi-functional bioactivities that are useful for a new discovery and/or reinvention of biologically active ingredients, nutraceuticals and/or pharmaceuticals. Therefore, in recent years, marine-derived bioactive peptides have gained a considerable attention with high-value biomedical and/or pharmaceutical potentials. Furthermore, a wider spectrum of bioactive peptides can be produced through proteolytic-assisted hydrolysis of various marine resources under controlled physicochemical (pH and temperature of the reaction media) environment. Owing to their numerous health-related beneficial effects and therapeutic potential in the treatment and/or prevention of many diseases, such marine-derived bioactive peptides exhibit a wider spectrum of biological activities such as anti-cancerous, anti-proliferative, anti-coagulant, antibacterial, antifungal, and anti-tumor activities among many others. Based on emerging evidence of marine-derived peptide mining, the above-mentioned marine resources contain noteworthy levels of high-value protein. The present review article mainly summarizes the marine-derived bioactive peptides and emphasizing their potential applications in biomedical and/or pharmaceutical sectors of the modern world. In conclusion, recent literature has provided evidence that marine-derived bioactive peptides play a critical role in human health along with many possibilities of designing new functional nutraceuticals and/or pharmaceuticals to clarify potent mechanisms of action for a wider spectrum of diseases.

  15. Thermal relics in hidden sectors

    SciTech Connect

    Feng, Jonathan L; Tu, Huitzu; Yu, Hai-Bo E-mail: huitzut@uci.edu

    2008-10-15

    Dark matter may be hidden, with no standard model gauge interactions. At the same time, in WIMPless models (WIMP: weakly interacting massive particles) with hidden matter masses proportional to hidden gauge couplings squared, the hidden dark matter's thermal relic density may naturally be in the right range, preserving the key quantitative virtue of WIMPs. We consider this possibility in detail. We first determine model-independent constraints on hidden sectors from big bang nucleosynthesis and the cosmic microwave background. Contrary to conventional wisdom, large hidden sectors are easily accommodated. A flavour-free version of the standard model is allowed if the hidden sector is just 30% colder than the observable sector after reheating. Alternatively, if the hidden sector contains a one-generation version of the standard model with characteristic mass scale below 1 MeV, even identical reheating temperatures are allowed. We then analyse hidden sector freeze-out in detail for a concrete model, solving the Boltzmann equation numerically and explaining the results from both observable and hidden sector points of view. We find that WIMPless dark matter does indeed obtain the correct relic density for masses in the range keV{approx}

  16. Evolution of Plant-Made Pharmaceuticals

    PubMed Central

    Thomas, David R.; Penney, Claire A.; Majumder, Amrita; Walmsley, Amanda M.

    2011-01-01

    The science and policy of pharmaceuticals produced and/or delivered by plants has evolved over the past twenty-one years from a backyard remedy to regulated, purified products. After seemingly frozen at Phase I human clinical trials with six orally delivered plant-made vaccines not progressing past this stage over seven years, plant-made pharmaceuticals have made a breakthrough with several purified plant-based products advancing to Phase II trials and beyond. Though fraught with the usual difficulties of pharmaceutical development, pharmaceuticals made by plants have achieved pertinent milestones albeit slowly compared to other pharmaceutical production systems and are now at the cusp of reaching the consumer. Though the current economic climate begs for cautious investment as opposed to trail blazing, it is perhaps a good time to look to the future of plant-made pharmaceutical technology to assist in planning for future developments in order not to slow this technology’s momentum. To encourage continued progress, we highlight the advances made so far by this technology, particularly the change in paradigms, comparing developmental timelines, and summarizing the current status and future possibilities of plant-made pharmaceuticals. PMID:21686181

  17. Vulnerabilities to misinformation in online pharmaceutical marketing.

    PubMed

    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.

  18. The distribution of pharmaceuticals in Europe--current and future trends in wholesaling.

    PubMed

    Andersson, F

    1994-03-01

    As of January 1, 1993 a huge market, encompassing more than 325 million people, has been established with the unification of the 12 member states in the European Community. During the last 10 years, the pharmaceutical wholesaling sector has therefore been involved in an intense restructuring process. But, there is a considerable scientific gap in the knowledge of pharmaceutical wholesaling. In view of the uncertain situation and the scarcity of structured information, the purpose of this article is to examine current and future trends in the European pharmaceutical wholesaling sector. We reviewed the literature and identified three major areas of interest; general threats to traditional full-line wholesaling, wholesalers' response to these threats, and the new Glaxo distribution scheme. The current and expected importance of these areas were assessed with the help of a survey, encompassing 20 experts in this field. Based on the review and the survey, we conclude that there are many serious threats to traditional wholesaling, the major ones being governmental pressures to lower the already relatively low gross margins, manufacturers contemplating taking over the drug distribution process themselves and increasing international competition. The major responses to these threats are to become a truly international player (via mergers, acquisitions and joint ventures), or being able to provide the customers with detailed management information through computerised networks. In order to survive the next 5-10 years, companies have to be very alert to the changing competitive situation.

  19. Temperature compensation for miniaturized magnetic sector

    NASA Technical Reports Server (NTRS)

    Sinha, Mahadeva P. (Inventor)

    2002-01-01

    Temperature compensation for a magnetic sector used in mass spectrometry. A high temperature dependant magnetic sector is used. This magnetic sector is compensated by a magnetic shunt that has opposite temperature characteristics to those of the magnet.

  20. Why the MDGs need good governance in pharmaceutical systems to promote global health

    PubMed Central

    2014-01-01

    Background Corruption in the health sector can hurt health outcomes. Improving good governance can in turn help prevent health-related corruption. We understand good governance as having the following characteristics: it is consensus-oriented, accountable, transparent, responsive, equitable and inclusive, effective and efficient, follows the rule of law, is participatory and should in theory be less vulnerable to corruption. By focusing on the pharmaceutical system, we explore some of the key lessons learned from existing initiatives in good governance. As the development community begins to identify post-2015 Millennium Development Goals targets, it is essential to evaluate programs in good governance in order to build on these results and establish sustainable strategies. This discussion on the pharmaceutical system illuminates why. Discussion Considering pharmaceutical governance initiatives such as those launched by the World Bank, World Health Organization, and the Global Fund, we argue that country ownership of good governance initiatives is essential but also any initiative must include the participation of impartial stakeholders. Understanding the political context of any initiative is also vital so that potential obstacles are identified and the design of any initiative is flexible enough to make adjustments in programming as needed. Finally, the inherent challenge which all initiatives face is adequately measuring outcomes from any effort. However in fairness, determining the precise relationship between good governance and health outcomes is rarely straightforward. Summary Challenges identified in pharmaceutical governance initiatives manifest in different forms depending on the nature and structure of the initiative, but their regular occurrence and impact on population-based health demonstrates growing importance of addressing pharmaceutical governance as a key component of the post-2015 Millennium Development Goals. Specifically, these challenges need

  1. Textile Manufacturing Sector (NAICS 313)

    EPA Pesticide Factsheets

    Find environmental regulatory and compliance information for the textile and leather manufacturing sector, including NESHAPs for leather tanning and fabric printing, and small business guidance for RCRA hazardous waste requirements.

  2. Chemical Manufacturing Sector (NAICS 325)

    EPA Pesticide Factsheets

    find EPA regulatory information for the chemical manufacturing sector, including NESHAPs, the SNAP program for ozone depleting substances,effluent guidelines, and new and existing chemicals testing requirements under TSCA.

  3. Wood and Paper Manufacturing Sectors

    EPA Pesticide Factsheets

    Find EPA regulatory information for the wood product and paper manufacturing sectors, including paper, pulp and lumber. Information includes NESHAPs and effluent guidelines for pulp and paper rulemaking, and compliance guidelines

  4. Public Service Motivation as a Predictor of Attraction to the Public Sector

    ERIC Educational Resources Information Center

    Carpenter, Jacqueline; Doverspike, Dennis; Miguel, Rosanna F.

    2012-01-01

    According to public service motivation theory, individuals with a strong public service orientation are attracted to government jobs. This proposition was investigated in three studies by measuring public sector motivation at a pre-entry level as an individual difference variable affecting perceptions of fit and organizational attraction. Results…

  5. Stakeholder Perception Comparison Through the Use of Mental Models

    NASA Astrophysics Data System (ADS)

    Tillotson, K.; Grecu, N.

    2012-12-01

    The WSC-Category 1 Sustainability Dynamics for Water Resources in a Rapidly Urbanizing and Climatically Sensitive Region grant seeks to develop an understanding of water planning and use for urbanization in the Spokane, Washington-Coeur d'Alene, Idaho Corridor. One way of achieving this understanding is through the use of mental mapping. A mental map is an internalized representation of a system or process that represents a real system, but does is not completely accurate (Doyle and Ford, 1997). Mental maps and models have potential application in risk assessment and perception comparison within or between interest groups, here referred to as sectors. Similarities and differences between the development sector and "expert" mental models, based on interviews from the development sector and from "experts" in water management and use, were examined in order to assess where gaps in knowledge lie or where the perceived risks are different between the two sectors. Assessing these differences can help target future communication between those that manage water and those that are impacted by water management practices. I will present briefly present the iterative steps of building the expert and development sector mental maps as well as the final mental map that combines expert and development perceptions. Discussion of the differences between the two sector maps and the implications of those differences will be included. Understanding these different perceptions is important in this region where water quantity and quality are highly regulated and development is rapid.

  6. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    EPA Pesticide Factsheets

    Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the individual activities of consumers and their environment. In contrast to other types of pollutants, PPCPs owe their origins in the environment directly to their worldwide, universal, frequent, highly dispersed, and individually small but aggregate/cumulative usage and disposal by multitudes of individuals. An overview of this multi-faceted issue can be found at a U.S. EPA web site (http://www.epa.gov/nerlesdl/chemistry/pharma/index.htm), which also provides a reprint of a review article published in Environmental Health Perspectives. PPCPs can enter the environment following their ingestion or application by the user or administration to domestic animals. Disposal of unused/expired PPCPS in landfills and to domestic sewage are additional routes to the environment. Domestic sewage treatment plants are not specifically engineered to remove PPCPS; the efficiencies with which they are removed from sewage vary from nearly complete to ineffective. The aquatic environment serves as the major, ultimate receptacle for most PPCPS. Little is known with respect to actual or even potential adverse effects on non-target species; human exposure via drinking water is poorly defined. While PPCPs in the environment (or domestic drinking water) are not regulated

  7. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    EPA Pesticide Factsheets

    Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the individual activities of consumers and their environment. In contrast to other types of pollutants, PPCPs owe their origins in the environment directly to their worldwide, universal, frequent, highly dispersed, and individually small but aggregate/cumulative usage and disposal by multitudes of individuals. An overview of this multi-faceted issue can be found at a U.S. EPA web site (http://www.epa.gov/nerlesdl/chemistry/pharma/index.htm), which also provides a reprint of an Environmental Health Perspectives review article. PPCPs can enter the environment via excreta or wash water following their ingestion or application by the user or administration to domestic animals. Direct disposal of unused/expired PPCPs in landfills and domestic sewage is an additional route to the environment. Domestic sewage treatment plants are not specifically engineered to remove PPCPS; removal efficiencies vary from nearly complete to ineffective. The aquatic and groundwater environments serve as the major, ultimate receptacles for most PPCPS. Little is known with respect to actual or even potential adverse effects on non-target species; human exposure via drinking water is poorly defined. While PPCPs in the environment (or drinking water) are not regulated, and even t

  8. Pharmaceutical research involving the homeless.

    PubMed

    Beauchamp, Tom L; Jennings, Bruce; Kinney, Eleanor D; Levine, Robert J

    2002-10-01

    Discussions of research involving vulnerable populations have left the homeless comparatively ignored. Participation by these subjects in drug studies has the potential to be upsetting, inconvenient, or unpleasant. Participation occasionally produces injury, health emergencies, and chronic health problems. Nonetheless, no ethical justification exists for the categorical exclusion of homeless persons from research. The appropriate framework for informed consent for these subjects of pharmaceutical research is not a single event of oral or written consent, but a multi-staged arrangement of disclosure, dialogue, and permission-giving. Payments and other rewards in biomedical research raise issues of whether it is ethical to offer inducements to the homeless in exchange for participation in drug studies. Such inducements can influence desperate persons who are seriously lacking in resources. The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement. This proposal does not underestimate the risks of research, which are often overestimated and need to be appraised in light of the relevant empirical literature.

  9. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    EPA Pesticide Factsheets

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

  10. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    EPA Pesticide Factsheets

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

  11. OVERVIEW OF PHARMACEUTICALS AND PERSONAL ...

    EPA Pesticide Factsheets

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

  12. ORIGINS AND RAMIFICATIONS OF PHARMACEUTICALS ...

    EPA Pesticide Factsheets

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

  13. PHARMACEUTICALS IN SOURCE WATER - OVERVIEW ...

    EPA Pesticide Factsheets

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

  14. INTRODUCTION TO PHARMACEUTICALS AND PERSONAL ...

    EPA Pesticide Factsheets

    There is no abstract for this product. If further information is requested, please refer to the bibliographic citation and contact the person listed under Contact field. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subtask 1: To integrate state-of-the-art technologies (polar organic chemical integrative samplers, advanced solid-phase extraction methodologies with liquid chromatography/electrospray/mass spectrometry) and apply them to studying the sources and fate of a select list of PPCPs. Application and improvement of analytical methodologies that can detect non-volatile, polar, water-soluble pharmaceuticals in source waters at levels that could be environmentally significant (at concentrations less than parts per billion, ppb). IAG with USGS ends in FY05. APM 20 due in FY05.Subtask 2: Coordination of interagency research and public outreach activities for PPCPs. Participate on NSTC Health and Environment subcommittee working group on PPCPs. Web site maintenance and expansion, invited technical presentations, invited articles for peer-reviewed journals, interviews for media, responding to public inquiries. Subtask 3: T

  15. WATER QUALITY MONITORING OF PHARMACEUTICALS ...

    EPA Pesticide Factsheets

    The demand on freshwater to sustain the needs of the growing population is of worldwide concern. Often this water is used, treated, and released for reuse by other communities. The anthropogenic contaminants present in this water may include complex mixtures of pesticides, prescription and nonprescription drugs, personal care and common consumer products, industrial and domestic-use materials and degradation products of these compounds. Although, the fate of these pharmaceuticals and personal care products (PPCPs) in wastewater treatment facilities is largely unknown, the limited data that does exist suggests that many of these chemicals survive treatment and some others are returned to their biologically active form via deconjugation of metabolites.Traditional water sampling methods (i.e., grab or composite samples) often require the concentration of large amounts of water to detect trace levels of PPCPs. A passive sampler, the polar organic chemical integrative sampler (POCIS), has been developed to integratively concentrate the trace levels of these chemicals, determine the time-weighted average water concentrations, and provide a method of estimating the potential exposure of aquatic organisms to these complex mixtures of waterborne contaminants. The POCIS (U.S. Patent number 6,478,961) consists of a hydrophilic microporous membrane, acting as a semipermeable barrier, enveloping various solid-phase sorbents that retain the sampled chemicals. Sampling rates f

  16. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    EPA Pesticide Factsheets

    Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the individual activities of consumers and their environment. In contrast to other types of pollutants, PPCPs owe their origins in the environment directly to their worldwide, universal, frequent, highly dispersed, and individually small but aggregate/cumulative usage and disposal by multitudes of individuals. An overview of this multi-faceted issue can be found at a U.S. EPA web site (http://www.epa.gov/nerlesdl/chemistry/pharma/index.htm), which also provides a reprint of a review article published in Environmental Health Perspectives as well as many other resources including several chapters from a new American Chemical Society book. PPCPs can enter the environment following their ingestion or application by the user or administration to domestic animals. Disposal of unused/expired PPCPs in landfills and to domestic sewage are additional routes to the environment. Domestic sewage treatment plants are not specifically engineered to remove PPCPS; the efficiencies with which they are removed from sewage vary from nearly complete to ineffective. The aquatic environment serves as the major, ultimate receptacle for most PPCPS. Little is known with respect to actual or even potential adverse effects on non-target species; human exposure via drinking wate

  17. PHARMACEUTICAL AND PERSONAL CARE PRODUCTS ...

    EPA Pesticide Factsheets

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

  18. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    EPA Pesticide Factsheets

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

  19. ORIGINS AND RAMIFICATIONS OF PHARMACEUTICALS ...

    EPA Pesticide Factsheets

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

  20. PREFACE TO: "PHARMACEUTICALS AND PERSONAL ...

    EPA Pesticide Factsheets

    Often overlooked in our daily lives are the inescapable, intimate, and immediate connections between our personal activities and the environment in which we live. This is especially true with regard to the use and disposal of consumer chemicals. A significant aspect of our global society that illustrates the potential impact of our lives on the environment is the widespread and escalating use of pharmaceuticals and personal care products - simply referred to as PPCPS. Many of these chemicals are specifically designed to elicit potent pharmacological or toxicological effects. In distinct contrast to nearly all agro/industrial chemicals, which are often used on large, relatively confined scales, the end use for PPCPs is highly dispersed and centered around the activities and actions of the individual. PPCPs enjoy worldwide usage and attendant discharge or inadvertent release to the environment. Their introduction to the environment has no geographic boundaries or climatic-use limitations as do many other synthetic chemicals - they are discharged to the environment wherever people live or visit, regardless of the time of year. It is difficult for the individual to perceive their small-scale activities as having any measurable impact on the larger environment - personal actions are often deemed minuscule or inconsequential in the larger scheme. Yet it is the combined actions and activities of individuals that indeed can significantly impact the environment in a myri

  1. PHARMACEUTICALS IN THE ENVIRONMENT: OVERVIEW ...

    EPA Pesticide Factsheets

    Pharmaceuticals and personal care products (PPCPs) comprise a large and diverse array of unregulated pollutants that can occur in the environment from the combined activities and actions of multitudes of individuals as well as from veterinary and agricultural use (http://epa.gov/nerlesd1/chemistry/pharma/images/drawing.pdf). Concerted research that began in Europe about two decades ago, and in the u.s. in the late 1990s, has begun escalating in the last few years. Investigation that was originally limited to studying the sources, origins, and occurrence of PPCPs primarily in waters has now expanded to encompass occurrence in other matrices and to consider the complexities involved with the range of unanticipated and subtle effects that might occur from low-dose. chronic exposure of non-target organisms. Risk management options designed around the principles of pollution prevention and environmental stewardship are also under discussion in the healthcare community. This paper will focus on the efforts being coordinated by the U.S. Environmental Protection Agency, much of which is captured on the PPCPs web site: http://epa.gov/nerlesd1/chemistry/pharma/. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth co

  2. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    EPA Pesticide Factsheets

    The occurrence of pharmaceuticals and personal care products (PPCPs) as trace environmental pollutants is a multifaceted issue whose scope of concerns continues to expand. PPCPs comprise thousands of distinct chemicals from numerous therapeutic and consumer classes. They typically occur as trace environmental pollutants (primarily in surface but also in ground waters) as a result of their widespread, continuous, combined usage in a broad range of human and veterinary therapeutic activities and practices. With respect to the risk-assessment paradigm, the growing body of published work has focused primarily on the origin and occurrence of these substances. Comparatively less is known about human and ecological exposure, and even less about the documented or potential hazards associated with trace exposure to these anthropogenic substances, many of which are highly bioactive and perpetually present in many aquatic locales. The continually growing, worldwide importance of freshwater resources underscores the need for ensuring that any aggregate or cumulative impacts on water supplies and resultant potential for human or ecological exposure be minimized.Of the many facets involved in this complex issue, that of sources/origins and environmental occurrence is the better understood end of the larger spectrum. The potential for adverse ecological or human health effects (especially from long-term, combined exposure to multiple xenobiotics at low concentrations) is the

  3. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    EPA Pesticide Factsheets

    The occurrence of pharmaceuticals and personal care products (PPCPs) as trace environmental pollutants is a multifaceted issue whose scope of concerns continues to expand. PPCPs comprise thousands of distinct chemicals from numerous therapeutic and consumer classes. They typically occur as trace environmental pollutants (primarily in surface but also in ground waters) as a result of their widespread, continuous, combined usage in a broad range of human and veterinary therapeutic activities and practices. With respect to the risk-assessment paradigm, the growing body of published work has focused primarily on the origin and occurrence of these substances. Comparatively less is known about human and ecological exposure, and even less about the documented or potential hazards associated with trace exposure to these anthropogenic substances, many of which are highly bioactive and perpetually present in many aquatic locales. The continually growing, worldwide importance of freshwater resources underscores the need for ensuring that any aggregate or cumulative impacts on water supplies and resultant potential for human or ecological exposure be minimized.Of the many facets involved in this complex issue, that of sources/origins and environmental occurrence is the better understood end of the larger spectrum. The potential for adverse ecological or human health effects (especially from long-term, combined exposure to multiple xenobiotics at low concentrations) is the l

  4. Roundtable discussion: what is the future role of the private sector in health?

    PubMed Central

    2014-01-01

    Background The role for the private sector in health remains subject to much debate, especially within the context of achieving universal health coverage. This roundtable discussion offers diverse perspectives from a range of stakeholders – a health funder, a representative from an implementing organization, a national-level policy-maker, and an expert working in a large multi-national company – on what the future may hold for the private sector in health. Discussion The first perspective comes from a health funder, who argues that the discussion about the future role of the private sector has been bogged down in language. He argues for a ‘both/and’ approach rather than an ‘either/or’ when it comes to talking about health service provision in low- and middle-income countries. The second perspective is offered by an implementer of health insurance in sub-Saharan Africa. The piece examines the comparative roles of public sector actors, private sector actors and funding agencies, suggesting that they must work together to mobilize domestic resources to fund and deliver health services in the longer term. Thirdly, a special advisor working in the federal government of Nigeria considers the situation in that country. He notes that the private sector plays a significant role in funding and delivering health services there, and that the government must engage the private sector or forever be left behind. Finally, a representative from a multi-national pharmaceutical corporation gives an overview of global shifts that are creating opportunities for the private sector in health markets. Summary Overall, the roundtable discussants agree that the private sector will play an important role in future health systems. But we must agree a common language, work together, and identify key issues and gaps that might be more effectively filled by the private sector. PMID:24961806

  5. Information flow in the pharmaceutical supply chain.

    PubMed

    Yousefi, Nazila; Alibabaei, Ahmad

    2015-01-01

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

  6. Mergers and innovation in the pharmaceutical industry.

    PubMed

    Comanor, William S; Scherer, F M

    2013-01-01

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

  7. ENVIRONMENTAL STEWARDSHIP OF PHARMACEUTICALS - THE GREEN PHARMACY

    EPA Science Inventory

    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...

  8. Paying for On-Patent Pharmaceuticals

    PubMed Central

    Goldfield, Norbert

    2016-01-01

    In this article we propose a new approach to pricing for patent-protected (on-patent) pharmaceuticals. We describe and define limit pricing as a method for drug companies to maximize revenue for their investment by offering budget-neutral pricing to encourage early adoption by payers. Under this approach, payers are incentivized to adopt innovative but expensive drugs more quickly if drug companies provide detailed analyses of the net impact of the new pharmaceutical upon total health budgets. For payers to adopt use of a new pharmaceutical, they would require objective third-party evaluation and pharmaceutical manufacturer accountability for projected outcomes efficacy of their treatments on population health. The pay for outcomes underpinning of this approach falls within the wider aspirations of health reform. PMID:26945298

  9. Information flow in the pharmaceutical supply chain

    PubMed Central

    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. PMID:26664401

  10. Pharmaceutical technology management--profitable business avenue.

    PubMed

    Puthli, Shivanand P

    2010-01-01

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

  11. Active Pharmaceutical Ingredients and Aquatic Organisms

    EPA Science Inventory

    The presence of active pharmaceuticals ingredients (APIs) in aquatic systems in recent years has led to a burgeoning literature examining environmental occurrence, fate, effects, risk assessment, and treatability of these compounds. Although APIs have received much attention as ...

  12. Pharmaceutical applications of non-linear imaging.

    PubMed

    Strachan, Clare J; Windbergs, Maike; Offerhaus, Herman L

    2011-09-30

    Non-linear optics encompasses a range of optical phenomena, including two- and three-photon fluorescence, second harmonic generation (SHG), sum frequency generation (SFG), difference frequency generation (DFG), third harmonic generation (THG), coherent anti-Stokes Raman scattering (CARS), and stimulated Raman scattering (SRS). The combined advantages of using these phenomena for imaging complex pharmaceutical systems include chemical and structural specificities, high optical spatial and temporal resolutions, no requirement for labels, and the ability to image in an aqueous environment. These features make such imaging well suited for a wide range of pharmaceutical and biopharmaceutical investigations, including material and dosage form characterisation, dosage form digestion and drug release, and drug and nanoparticle distribution in tissues and within live cells. In this review, non-linear optical phenomena used in imaging will be introduced, together with their advantages and disadvantages in the pharmaceutical context. Research on pharmaceutical and biopharmaceutical applications is discussed, and potential future applications of the technology are considered.

  13. Agreements at the Pharmaceutical/University Interface.

    ERIC Educational Resources Information Center

    Ku, Katherine

    1987-01-01

    Specific agreements that arise at the interface between universities and pharmaceutical companies are described including sponsored research agreements, license agreements, clinical study agreements, material transfer agreements, and patient consent forms with respect to commercialization rights. (Author/MLW)

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

    PubMed Central

    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 <1 μg/L. Four pharmaceuticals (methadone, oxycodone, butalbital, and metaxalone) in samples of NY3 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

  15. Why are pharmaceutical companies gradually abandoning vaccines?

    PubMed

    Offit, Paul A

    2005-01-01

    During the past fifty years, the number of pharmaceutical companies making vaccines has decreased dramatically, and those that still make vaccines have reduced resources to make new ones. Pharmaceutical companies are gradually abandoning vaccines because the research, development, testing, and manufacture of vaccines are expensive and because the market to sell vaccines is much smaller than the market for other drug products. Congressional action could assure both a steady supply of existing vaccines and the promise of vaccines for the future.

  16. Production of Plasmid DNA as Pharmaceutical.

    PubMed

    Schmeer, Marco; Schleef, Martin

    2015-01-01

    Pharmaceutical applications of plasmid DNA require certain quality standards, depending on the intended use of the plasmids. That is, for direct gene transfer into human, GMP Grade is mandatory, however, for GMP production of for example viral vectors (AAV or mRNA etc.), the plasmid DNA used has not to be produced under GMP necessarily. Here we summarize important features of producing plasmid DNA, ensuring the required quality for the intended (pharmaceutical) application.

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

    PubMed

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

    2015-03-01

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

  18. Short Summary European Reports on Retail Sector, Motor Vehicle Repair and Sales Sector, Food and Beverages Sector.

    ERIC Educational Resources Information Center

    European Centre for the Development of Vocational Training, Berlin (Germany).

    This document is composed of European synthesis reports on retail trade, the agro-food sector, and the motor vehicle sales and repair sector. They are based on the most important findings of the European report and the 12 national reports for each sector. Section 1, "Retail Sector," deals in part 1 with the structure of retailing in the…

  19. Bromination of selected pharmaceuticals in water matrices.

    PubMed

    Benitez, F Javier; Acero, Juan L; Real, Francisco J; Roldan, Gloria; Casas, Francisco

    2011-11-01

    The bromination of five selected pharmaceuticals (metoprolol, naproxen, amoxicillin, phenacetin, and hydrochlorothiazide) was studied with these compounds individually dissolved in ultra-pure water. The apparent rate constants for the bromination reaction were determined as a function of the pH, obtaining the sequence amoxicillin>naproxen>hydrochlorothiazide≈phenacetin≈metoprolol. A kinetic mechanism specifying the dissociation reactions and the species formed for each compound according to its pK(a) value and the pH allowed the intrinsic rate constants to be determined for each elementary reaction. There was fairly good agreement between the experimental and calculated values of the apparent rate constants, confirming the goodness of the proposed reaction mechanism. In a second stage, the bromination of the selected pharmaceuticals simultaneously dissolved in three water matrices (a groundwater, a surface water from a public reservoir, and a secondary effluent from a WWTP) was investigated. The pharmaceutical elimination trend agreed with the previously determined rate constants. The influence of the main operating conditions (pH, initial bromine dose, and characteristics of the water matrix) on the degradation of the pharmaceuticals was established. An elimination concentration profile for each pharmaceutical in the water matrices was proposed based on the use of the previously evaluated apparent rate constants, and the theoretical results agreed satisfactorily with experiment. Finally, chlorination experiments performed in the presence of bromide showed that low bromide concentrations slightly accelerate the oxidation of the selected pharmaceuticals during chlorine disinfection.

  20. Pharmaceutical regulation in 15 European countries review.

    PubMed

    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.

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

    PubMed

    Cohen, A F

    2001-07-28

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

  2. Stereoscopic Perception

    NASA Astrophysics Data System (ADS)

    Clapp, Robert E.

    1987-06-01

    There is only one real world, We "see" that world as extending into three dimensions because we look at it with two eyes. We are not presented with two "pictures" of the real world, but with two separate views. Views not pictures. The analog of the eye as a camera has done violence to the development of concepts of human vision. The eye is a dynamic sensing apparatus that supplies the brain with inputs from which the brain constructs the scene we "see", and so is responsible for our perceptual structuring of the real world. These visual perceptions are dependent upon our other sensory inputs as well. Indeed, our body senses control and direct, to some degree, where out eyes look and what we "see". This process of conceptualization is thoroughly egocentric. This paper addresses the processes by which our mind/eye/senses interact to form our perception (and concepts) of the world (real or illusionary) and the advantages (and problems) of our egocentric reduction of the data inputs.

  3. Physicians’ perceptions of medical representative visits in Yemen: a qualitative study

    PubMed Central

    2013-01-01

    Background The pharmaceutical industry invests heavily in promotion, and it uses a variety of promotional strategies to influence physicians’ prescribing decisions. Within this context, medical representatives (MRs) are the key personnel employed in promoting their products. One significant consequence of the interactions between physicians and medical representatives is a conflict of interests which may contribute to the over prescribing of medications and thus negative effects on patients’ health and economics. There is limited detailed information published on the reasons why physicians interact with pharmaceutical representatives. This study aims to qualitatively explore physicians’ attitudes about interactions with medical representatives and their reasons for accepting the medical representatives’ visits. Methods In-depth interviews were used to gain a better understanding of physicians’ perceptions of medical representative visits. A total of 32 physicians from both private and public hospitals were interviewed. The recordings of the interviews were transcribed verbatim and subject to thematic analysis using a framework analysis approach. Results The present qualitative study found that the majority of the physicians had positive interactions with medical representatives. The physicians’ main reasons stated for allowing medical representatives’ visits are the social contacts and mutual benefits they will gain from these representatives. They also emphasized that the meeting with representatives provides educational and scientific benefits. A few physicians stated that the main reasons behind refusing the meeting with medical representatives were lack of conviction about the product and obligation to prescribe medicine from the representative company. Most of the physicians believed that they were under marketing pressure to prescribe certain medicines. Conclusions Although physicians are aware that the medical representatives could influence

  4. Cure for empire: the 'Conquer-Russia-Pill', pharmaceutical manufacturers, and the making of patriotic Japanese, 1904-45.

    PubMed

    Kim, Hoi-Eun

    2013-04-01

    Seirogan, a popular anti-diarrhoeal pill, is arguably one of the most successful pharmaceutical products of modern Japan. What is less known is that the Japanese army initially developed Seirogan during the Russo-Japanese War as the ‘Conquer-Russia-Pill’, which was later marketed to the public by private manufacturers. Previous scholars have emphasised the top–down governmental method of mobilising private sectors to manipulate public opinion for the cause of external imperialist expansion and domestic stability during wartime Japan. But the matrix that the Conquer-Russia-Pill allows us to glimpse is an inverted power relation among the state, commercial sectors, and imperial citizens. While the Japanese government remained indifferent if not hostile to jingoistic pharmaceutical manufacturers who could easily disrupt international relations, pharmaceutical companies quickly recognised and exploited the opportunities that the Conquer-Russia-Pill and its symbolism provided under the banner of the empire. In turn, Japanese consumers reacted to commercial sermons carefully anchored in patriotic and militaristic discourses and images by opening their wallets. In other words, the popularity of the Conquer-Russia-Pill was a culmination of the convergence of a governmental initiative to enhance military capabilities, the commercial ingenuity of pharmaceutical manufacturers, and a consumer response to patriotic exhortations.

  5. Stem cells in pharmaceutical biotechnology.

    PubMed

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

    2011-11-01

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

  6. 50 CFR 648.87 - Sector allocation.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Fixed Gear Sector, as defined in § 648.87(d)(1) or (2), joins a new sector, or fishes pursuant to the...) Areas that can be fished. Vessels in a sector may only fish in a particular stock area, as specified in... penalty shall be applied to any member permit/vessel that leaves that sector to fish under the...

  7. 50 CFR 648.87 - Sector allocation.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Fixed Gear Sector, as defined in § 648.87(d)(1) or (2), joins a new sector, or fishes pursuant to the...) Areas that can be fished. Vessels in a sector may only fish in a particular stock area, as specified in... penalty shall be applied to any member permit/vessel that leaves that sector to fish under the...

  8. Spatially Enabling the Health Sector

    PubMed Central

    Weeramanthri, Tarun Stephen; Woodgate, Peter

    2016-01-01

    Spatial information describes the physical location of either people or objects, and the measured relationships between them. In this article, we offer the view that greater utilization of spatial information and its related technology, as part of a broader redesign of the architecture of health information at local and national levels, could assist and speed up the process of health reform, which is taking place across the globe in richer and poorer countries alike. In making this point, we describe the impetus for health sector reform, recent developments in spatial information and analytics, and current Australasian spatial health research. We highlight examples of uptake of spatial information by the health sector, as well as missed opportunities. Our recommendations to spatially enable the health sector are applicable to high- and low-resource settings. PMID:27867933

  9. Network topology of economic sectors

    NASA Astrophysics Data System (ADS)

    Djauhari, Maman A.; Gan, Siew Lee

    2016-09-01

    A lot of studies dealing with stock network analysis, where each individual stock is represented by a univariate time series of its closing price, have been published. In these studies, the similarity of two different stocks is quantified using a Pearson correlation coefficient on the logarithmic price returns. In this paper, we generalize the notion of similarity between univariate time series into multivariate time series which might be of different dimensions. This allows us to deal with economic sector network analysis, where the similarity between economic sectors is defined using Escoufier’s vector correlation RV. To the best of our knowledge, there is no study dealing with this notion of economic sector similarity. Two examples of data from the New York stock exchange will be presented and discussed, and some important results will be highlighted.

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

    PubMed

    Chakraborty, Sweta; Bouder, Frederic

    2013-02-01

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

  11. Design of experiments (DoE) in pharmaceutical development.

    PubMed

    N Politis, Stavros; Colombo, Paolo; Colombo, Gaia; M Rekkas, Dimitrios

    2017-02-23

    At the beginning of the twentieth century, Sir Ronald Fisher introduced the concept of applying statistical analysis during the planning stages of research rather than at the end of experimentation. When statistical thinking is applied from the design phase, it enables to build quality into the product, by adopting Deming's profound knowledge approach, comprising system thinking, variation understanding, theory of knowledge, and psychology. The pharmaceutical industry was late in adopting these paradigms, compared to other sectors. It heavily focused on blockbuster drugs, while formulation development was mainly performed by One Factor At a Time (OFAT) studies, rather than implementing Quality by Design (QbD) and modern engineering-based manufacturing methodologies. Among various mathematical modeling approaches, Design of Experiments (DoE) is extensively used for the implementation of QbD in both research and industrial settings. In QbD, product and process understanding is the key enabler of assuring quality in the final product. Knowledge is achieved by establishing models correlating the inputs with the outputs of the process. The mathematical relationships of the Critical Process Parameters (CPPs) and Material Attributes (CMAs) with the Critical Quality Attributes (CQAs) define the design space. Consequently, process understanding is well assured and rationally leads to a final product meeting the Quality Target Product Profile (QTPP). This review illustrates the principles of quality theory through the work of major contributors, the evolution of the QbD approach and the statistical toolset for its implementation. As such, DoE is presented in detail since it represents the first choice for rational pharmaceutical development.

  12. Water and stability of pharmaceutical solids

    NASA Astrophysics Data System (ADS)

    Shalaev, Evgenyi

    2007-03-01

    Solid pharmaceuticals are multi-component systems consisting of an active pharmaceutical ingredient (API) and inactive ingredients (excipients). Excipients may include inorganic salts (e.g., NaCl), carbohydrates (e.g., lactose), and polymers, to name a few, whereas APIs range from relatively simple molecules (e.g., aspirin) to proteins and olygonucleotides. Pharmaceutical solids could exist either as single-phase or heterophase systems. They also may have different extent of order, such as highly ordered crystalline phases, amorphous solids that are thermodynamically unstable but might be kinetically stable under the time frame of observation, and crystalline mesophases including liquid crystals. With all this diversity, there are common features for such systems, and two of them will be discussed in the presentation. (i) Requirements for chemical stability of pharmaceuticals are very strict. A very limited (e.g., less than 0.1%) extent of conversion is allowed in these materials over the shelf life, i.e., during several years of storage at ambient and (sometimes) not fully controlled (e.g., a medicine cabinet in one's bathroom) conditions. (ii) All pharmaceutical solids contain some water, although its amount and physical state are highly variable and may change during manufacturing and shelf life. There are many challenging questions and issues associated with the ``Water and stability of pharmaceutical solids'' subject; some of them will be considered in the presentation: (i) What are the features of chemical reactivity of crystalline vs disordered systems? (ii) What is the role of water in solid state chemical reactivity of amorphous solids, e.g., water as plasticizer vs reactant vs reaction media? (iii) How homogeneous are pharmaceutical amorphous solid solutions, e.g., carbohydrate-water systems? (iv) What is the optimal water content? With water being the most common destabilizing factor, is ``the drier - the better'' always the case?

  13. [Social change and Pharmaceutical Affairs Law (PAL)].

    PubMed

    Masuyama, Koichi; Isobe, Soichiro

    2010-01-01

    Former Japanese pharmaceutical laws, originally based on the Pharmaceutical Marketing and Handling Regulations enacted in 1874 were in operation for many years before World War II. However, in order to address several drug issues, such as poor drug quality and insufficiences regarding the role of pharmacists during the War, the laws needed to be unified and revised. In this paper, we analyzed the record of discussions held by the Imperial Diet on the bill for the Pharmaceutical Affairs Law (PAL) in 1943. This is also regarded as the origin of the current PAL (LawNo.145 in 1960). Through this analysis, we tried to clarify the relationship between the social change and the role of PAL in society. During the War, the bill was discussed, aiming at the improvement of both human resources who treated drugs, and the quality of drug materials. Diet members discussed three main points, namely, "the duty of pharmacists", "the mission of the Japan Pharmaceutical Association" and "the quality control of pharmaceutical products". Notably, the bill pharmacists are required not only to dispense drugs, a role they had previously, but also to manage drug and food hygiene through the quality control of pharmaceutical products and the inspection of food and drink, in order to improve the public health in Japan. Originally, the law was passed to deal with the extraordinary circumstances during the War, but through our analysis, we found that they proactively improved the role of the law to comply with various drug issues raised during the War, the rapid change of the pharmaceutical hygiene concept and the social transformation.

  14. The UK pharmaceutical market. An overview.

    PubMed

    Towse, A

    1996-01-01

    The National Health Service (NHS) accounts for more than 98% of the UK prescription medicines market, which is the sixth largest pharmaceutical market in the world. Most of this market is driven by the UK's approximately 35,000 general practitioners (GPs). It is an open market, with most leading foreign pharmaceutical companies having a strong presence. While the growth rate of this market has been decelerating, it remains one of the fastest growing components of NHS expenditure. The NHS does not operate any kind of national reimbursement list, but the UK government has adopted several means to keep medicines expenditure under control. These include cash incentives and constraints for GPs relating to expenditure on medicines, individual quarterly updates on GP prescribing, the publication of a list of medicines that cannot be prescribed by GPs, the switching of some prescription-only medicines to over-the-counter medicines, and a co-payment system. The main form of economic regulation in the UK, however, remains the Pharmaceutical Price Regulation Scheme (PPRS). This limits the rate-of-return on capital attributable to medicines sales to the NHS, with the intended rate-of-return being equal to that of UK industry overall. The pharmaceutical industry has generally performed relatively well in the UK market, managing to preserve incentives to innovation. This reflects the fact that UK GPs have been able to maintain their clinical freedom, as well as government recognition of the economic contribution made by the pharmaceutical industry. Current issues of interest in the UK pharmaceutical market context include the future of the PPRS, the debates over the imposition of a national formulary and generic substitution, and over parallel trade, the potential impact of managed-care protocols and computer-based prescribing on pharmaceutical expenditures, and possible political changes.

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

    EPA Science Inventory

    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...

  16. Economic Indicators of the Farm Sector. Farm Sector Review, 1986.

    ERIC Educational Resources Information Center

    Economic Research Service (USDA), Washington, DC.

    This report contains 44 tables and 23 figures, along with narrative summaries, that provide an overall view of the farm sector in the United States in 1986. Some of the findings highlighted in the report are the following: (1) farmers spent less to produce their crops and livestock in 1986; (2) government payments to farmers increased, but prices…

  17. The biotech equipment and supplies sector in Europe-is it European?

    PubMed

    Reiss, Thomas; Woerner, Stefan

    2002-09-11

    Socio-economic research on biotechnology is dealing mainly with the sectors of biopharmaceuticals, agro-food or environmental technologies. In contrast, the equipment and supplies sector seems to be largely ignored. This is surprising because this sector provides important input in terms of technology and material for the development of biotechnology in general. Our comparative analysis of the sector in eight countries indicates that there exists no specific science base for the sector and that it is largely neglected by public research funding. Commercial activities are concentrated in countries with a large general science base in biotechnology and strong multinational pharmaceutical or chemical companies. There is a rather broad diversity in the way the sector has developed in the eight countries. Our data support the notion that national peculiarities seem dominant for explaining this picture. We anticipate growing business opportunities for European firms to step into large markets of equipment and supplies for functional genomics and protein analyses where Europe maintains a strong science base.

  18. Attitude toward Democracy in Pakistan: Secondary School Teachers' Perceptions

    ERIC Educational Resources Information Center

    Sarwar, Muhammad; Yousuf, Muhammad Imran; Hussain, Shafqat

    2010-01-01

    The study aimed at exploring the public sector secondary school teachers' perceptions for development of democratic values and strategies to improve the democratic system and attitudes toward democracy. Sixty secondary school teachers were selected as a sample. The qualitative data in the form of interview responses were collected to explore…

  19. Qualification Users' Perceptions and Experiences of Assessment Reliability

    ERIC Educational Resources Information Center

    Chamberlain, Suzanne

    2013-01-01

    This paper presents the findings of a study designed to explore qualification users' perceptions and experiences of reliability in the context of national assessment outcomes in England. The study consisted of 17 focus groups conducted across six sectors of qualification users: students, teachers, trainee teachers, job-seekers, employers and…

  20. New pharmaceuticals reduce cost of illness.

    PubMed

    Hansen, R W

    1986-06-01

    The cost of illness includes not only the funds required to treat illness, but also the effect on the patient's quality of life. Recent concern about rising health costs have focused on the direct expenditures without noting that the cost of illness in terms of mortality and morbidity has declined significantly. Pharmaceuticals have played a major role in reducing the total cost of illness. Several studies of the cost-effectiveness of past introductions of vaccines and pharmaceuticals reveal large cost savings. Although the focus of most studies has been on major advances, the continuing process of less dramatic therapeutic improvements has significantly trimmed the cost of illness. Cost-benefit studies of new drugs or changes in drug use, while more difficult to perform, make it possible to influence the selection of therapy. Since pharmaceuticals represent less than 10% of total treatment costs, reduction in the cost of pharmaceutical products can only have a minor impact on the total cost of illness. Pharmaceuticals can reduce the cost of illness by providing alternative therapies that reduce direct treatment cost or improve the public health.

  1. Characterization and Quality Control of Pharmaceutical Cocrystals.

    PubMed

    Izutsu, Ken-Ichi; Koide, Tatsuo; Takata, Noriyuki; Ikeda, Yukihiro; Ono, Makoto; Inoue, Motoki; Fukami, Toshiro; Yonemochi, Etsuo

    2016-10-01

    Recent active research and new regulatory guidance on pharmaceutical cocrystals have increased the rate of their development as promising approaches to improve handling, storage stability, and bioavailability of poorly soluble active pharmaceutical ingredients (APIs). However, their complex structure and the limited amount of available information related to their performance may require development strategies that differ from those of single-component crystals to ensure their clinical safety and efficacy. This article highlights current methods of characterizing pharmaceutical cocrystals and approaches to controlling their quality. Different cocrystal regulatory approaches between regions are also discussed. The physical characterization of cocrystals should include elucidating the structure of their objective crystal form as well as their possible variations (e.g., polymorphs, hydrates). Some solids may also contain crystals of individual components. Multiple processes to prepare pharmaceutical cocrystals (e.g., crystallization from solutions, grinding) vary in their applicable ingredients, scalability, and characteristics of resulting solids. The choice of the manufacturing method affects the quality control of particular cocrystals and their formulations. In vitro evaluation of the properties that govern clinical performance is attracting increasing attention in the development of pharmaceutical cocrystals. Understanding and mitigating possible factors perturbing the dissolution and/or dissolved states, including solution-mediated phase transformation (SMPT) and precipitation from supersaturated solutions, are important to ensure the bioavailability of orally administrated lower-solubility APIs. The effect of polymer excipients on the performance of APIs emphasizes the relevance of formulation design for appropriate use.

  2. Pharmaceutical supply chain risks: a systematic review

    PubMed Central

    2013-01-01

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

  3. Cloud computing in pharmaceutical R&D: business risks and mitigations.

    PubMed

    Geiger, Karl

    2010-05-01

    Cloud computing provides information processing power and business services, delivering these services over the Internet from centrally hosted locations. Major technology corporations aim to supply these services to every sector of the economy. Deploying business processes 'in the cloud' requires special attention to the regulatory and business risks assumed when running on both hardware and software that are outside the direct control of a company. The identification of risks at the correct service level allows a good mitigation strategy to be selected. The pharmaceutical industry can take advantage of existing risk management strategies that have already been tested in the finance and electronic commerce sectors. In this review, the business risks associated with the use of cloud computing are discussed, and mitigations achieved through knowledge from securing services for electronic commerce and from good IT practice are highlighted.

  4. Inter-Sectoral Educational Planning.

    ERIC Educational Resources Information Center

    Organisation for Economic Cooperation and Development, Paris (France).

    This book contains papers discussing inter-sectoral educational planning in countries belonging to the Organisation for Economic Co-operation and Development (OECD). Intersectoral educational planning is interpreted as educational policy formation by any country which takes into consideration influences generated by that country's social and…

  5. Does Your Drug Expertise Include Clinical Pharmaceutics?

    PubMed

    Newton, David W

    2016-01-01

    Whose job is it to protect patients from harm from drug instabilities and incompatibilities and other aspects of clinical pharmaceutics? Pharmacists are better educated via multiple required general and organic chemistry prerequisite and professional curricula medicinal chemistry and pharmaceutics courses. Therefore, no healthcare professional other than pharmacists are nicknamed drug experts or are better formally educated to master drug chemistry in the bottle (i.e., injection stability and compatibility/incompatibility clinical pharmaceutics) as a prerequisite for drug administration to cause safe and effective drug chemistry in the body (i.e., clinical pharmacokinetics and pharmacology). To be a patient's last chance for safe and effective drug therapy requires terminal control by pharmacists over identification, retrieval, preparation, labeling, and counseling or instruction of drug therapy.

  6. Thermal properties of food and pharmaceutical powders

    NASA Astrophysics Data System (ADS)

    Abiad, Mohamad Ghassan

    Foods and pharmaceuticals are complex systems usually exposed to various environmental conditions during processing and thus storage, stability, functionality and quality are key attributes that deserve careful attention. The quality and stability of foods and pharmaceuticals are mainly affected by environmental conditions such as temperature, humidity, time, and processing conditions (e.g. shear, pressure) under which they may undergo physical and/or chemical transformations. Glass transition as well as other thermal properties is a key to understand how external conditions affect physical changes of such materials. Development of new materials and understanding the physico-chemical behavior of existing ones require a scientific foundation that translates into safe and high quality foods, improved quality of pharmaceuticals and nutraceuticals with lower risk to patients and functional efficacy of polymers used in food and medicinal products. This research provides an overview of the glass transition and other thermal properties and introduces novel methods developed to characterize such properties.

  7. Pharmaceutical strategy and innovation: an academics perspective.

    PubMed

    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.

  8. Modeling choice behavior for new pharmaceutical products.

    PubMed

    Bingham, M F; Johnson, F R; Miller, D

    2001-01-01

    This paper presents a dynamic generalization of a model often used to aid marketing decisions relating to conventional products. The model uses stated-preference data in a random-utility framework to predict adoption rates for new pharmaceutical products. In addition, this paper employs a Markov model of patient learning in drug selection. While the simple learning rule presented here is only a rough approximation to reality, this model nevertheless systematically incorporates important features including learning and the influence of shifting preferences on market share. Despite its simplifications, the integrated framework of random-utility and product attribute updating presented here is capable of accommodating a variety of pharmaceutical marketing and development problems. This research demonstrates both the strengths of stated-preference market research and some of its shortcomings for pharmaceutical applications.

  9. Agglomeration tendency in dry pharmaceutical granular systems.

    PubMed

    Lachiver, Emilie DesRosiers; Abatzoglou, Nicolas; Cartilier, Louis; Simard, Jean-Sébastien

    2006-10-01

    The agglomeration tendency of dry pharmaceutical mixtures containing various concentrations of Xylitab 100 (Xylitol), calcium carbonate precipitated (CCP) and magnesium stearate (MgSt) was evaluated statistically as a function of mixing time. A Ro-Tap tester was employed to mix the three pharmaceutical components, and the agglomerates formed were measured with respect to their weight and size. An experimental design was devised and applied to structure and then statistically analyze the results. Xylitab was found not to be influential in the formation of agglomerates, but aided in deagglomeration when mixed with other components. CCP and MgSt formed agglomerates over time and showed positive interactions favouring agglomeration. The agglomerates started to fracture when they reached a critical size, at which stage the particles' attraction forces (cohesion forces) were weaker than both gravity and inertia. It has been shown and quantitatively demonstrated that the mixing time and ingredient concentrations of a three-component pharmaceutical mixture can affect agglomeration tendency.

  10. Marketing concepts for pharmaceutical service development.

    PubMed

    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.

  11. Globalization and the pharmaceutical industry revisited.

    PubMed

    Busfield, Joan

    2003-01-01

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

  12. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2009-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new standards and guidelines were adopted and recommended for use: the current list of available International Chemical Reference Substances and International Infrared Reference Spectra; guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products; procedure for prequalification of pharmaceutical products; and the procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products.

  13. WHO Expert Committee on specifications for pharmaceutical preparations.

    PubMed

    2010-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality control laboratories; supplementary guidelines for active pharmaceutical ingredients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products; good distribution practices for pharmaceutical products; guidelines on the requalification of prequalified dossiers: and guidelines for the preparation of a contract research organization master file.

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

    PubMed Central

    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. Assessing potential impacts of the EVFTA on Vietnam's pharmaceutical imports from the EU: an application of SMART analysis.

    PubMed

    Vu, Huong Thanh

    2016-01-01

    This paper by adopting the Software on Market Analysis and Restrictions on Trade assessed the ex-ante impact of tariff elimination under the European-Vietnam free trade agreement (EVFTA) on Vietnam's pharmaceutical imports from the EU based on two scenarios. The results showed that although Vietnam's tariff removal for the EU's medicines would not result in a significant increase in Vietnam's imports from the EU, Vietnam's deeper integration with ASEAN + 3 and TPP (the Trans-Pacific Partnership) nations would affect quite slightly on its imports from the EU. Therefore, the EU would be still the most important and biggest source of pharmaceuticals for Vietnam in the near future. In addition, there might be an uneven distribution in Vietnam's import increases by the EU nation, pharmaceutical group and product. The simulation results also pointed out that the EVFTA's trade creation effect would be higher than trade diversion effect and therefore the agreement would improve welfare of Vietnam. When Vietnam extends its coverage of tariff elimination to also TPP and ASEAN + 3, Vietnam's welfare would potentially increase more but Vietnam would face with the relatively high increases of pharmaceutical imports from not only the EU but also the US, Australia, South Korea, Thailand and China. Bases on these results, the paper argued that both the Vietnamese government and pharmaceutical enterprises should not neglect the EVFTA and its impacts on the pharmaceutical sector, and perceive clearly the uneven distribution of Vietnam's import changes from the EU by nation and by product to design appropriate business and investment strategy. In addition, Vietnam should take measures to diversify its European import markets to be less dependent on the traditional ones in the current context of the EU. Finally, Vietnam should promote the integration in the pharmaceutical sector with all three groups of nations, especially ASEAN and ASEAN's key partners, to reduce trade diversion

  16. The pharmaceutical sciences in 2020--report of a conference organized by the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP).

    PubMed

    Shah, Vinod P; Besançon, Luc J R; Stolk, Pieter; Tucker, Geoffrey; Crommelin, Daan J A

    2009-12-08

    In accordance with its missions, the Board of Pharmaceutical Sciences (BPS) of the International Pharmaceutical Federation (FIP) has developed a view on the future of pharmaceutical sciences in 2020. This followed an international conference with invited participants from various fields (scientists, academicians, regulators, industrialists, venture capitalists...) who shared their views on the forces that might determine how the pharmaceutical sciences will look in 2020. The participants of the conference identified major research activities which will drive drug discovery and development, the enabling technologies, as well as likely paradigm shifts in drug discovery, development, regulation and usage. In addition, they discussed the translation of these changes into the education of pharmaceutical scientists and the potential role of FIP. The outcome of this exercise could serve as a starting point for a scenario analysis of the future of pharmaceutical sciences and the challenges that await the pharmaceutical scientist.

  17. Student Perceptions of the Benefits of a Learner-Based Writing Assignment in Organic Chemistry

    ERIC Educational Resources Information Center

    Ablin, Lois

    2008-01-01

    A writing assignment to increase student understanding of and interest in practical applications of organic chemistry is described. Students were required to study a pharmaceutical or other organic compound and perform a qualitative risk assessment on the chemical. Student perceptions of the benefits of the paper were generally positive. (Contains…

  18. MSc degree in color technology for the automotive sector

    NASA Astrophysics Data System (ADS)

    Martinez-Verdu, F.; Perales, E.; Chorro, E.; Viqueira, V.; Gilabert, E.

    2014-07-01

    Nowadays, the measurement and management of color quality of the gonio-apparent materials is complex, but highly demanded in many industrial sectors, as automotive, cosmetics, plastics for consumer electronics, printing inks, architectural coatings, etc. It is necessary to control complex instrumentation and to do visual assessments of texture and color differences to get, for instance, a visual harmony in car bodies; and a profound knowledge of physics and chemistry of special-effect pigments for their optical formulation to obtain attractive visual effects in coatings, plastics, etc, combining among them and with solid pigments. From University of Alicante, for the academic year 2013-14, we are organizing the first MSc degree in Color Technology for the Automotive Sector, with a design of contents embracing CIE colorimetry and visual perception, included the AUDI2000 color difference formula, instrumentation and color management software, fundamentals of coatings and plastics in the automotive sector, and, optical formulation of pigments. The MSc syllabus, with 60 ECTS, is designed to be taught in two semesters: from September to February with on classroom theoretical and practical activities, and, from March to June at virtual level, with internships of training in some companies. Therefore, the MSc Thesis would be the performance report during the internship in companies or research institutions. Some multinational companies, both as car makers and coatings and plastics providers, from European and non-European countries have already shown their support and interest in welcoming students for specific training, even some job offers when the first MSc edition finishes.

  19. Profit, payment and pharmaceutical practices: perspectives from hospitals in Bangkok.

    PubMed

    Pitaknetinan, K; Tangcharoensathien, V; Supachutikul, A; Bennett, S; Mills, A

    1999-03-01

    Means by which to improve the quality of care offered in the private sector have received increasing interest. This paper considers the influences upon hospital physician prescribing practices. It presents data on drug management practices and prescribing patterns in a sample of private for-profit, private non-profit and public hospitals in Bangkok. Clear differences emerge in prescription patterns between the different groups of hospitals: public hospitals exhibit greater use of essential drugs and generic prescribing than either group of private hospital, and prescriptions at private for-profit hospitals tended to have more essential drugs and drugs prescribed by generic name than non-profit hospitals. Prescribing patterns in public hospitals are probably largely explained by national government policy on pharmaceutical procurement. In contrast, prescribing patterns in private for-profit hospitals appear heavily influenced by pressure upon management to contain costs, in circumstances where high drug costs cannot be passed on to purchasers. Hence hospital management have developed policies encouraging the use of generic drugs and essential drugs. These same financial pressures also explain some less desirable forms of behaviour in private for-profit hospitals such as prescribing courses of antibiotic treatment of extremely short duration. Possible measures which government may take to encourage appropriate prescribing within private hospitals are discussed.

  20. Printed sectoral horn power combiner

    NASA Astrophysics Data System (ADS)

    Boccia, Luigi; Emanuele, Antonio; Shamsafar, Alireza; Arnieri, Emilio; Amendola, Giandomenico

    2015-02-01

    In this work, it is presented a new configuration of planar power combiner/divider based on an H-plane sectoral horn antenna. This component is proposed to realise the basic building blocks of printed power-combining amplifiers. It will be shown how the sectoral horn elements can be implemented on substrate integrated waveguide and multilayer printed circuit board technologies, thus obtaining a high integration level. In the following, the design procedure will be described reporting an example of an 11-stage power divider/combiner in C-band. A prototype has been fabricated, and the measured results compared with the numerical model. Experimental results are in good agreement with theoretical expectations showing a single-stage efficiency of about 90% and a bandwidth of 40%.

  1. NON-TRADITIONAL RESPONSES TO PHARMACEUTICALS IN AQUATIC ECOSYSTEMS

    EPA Science Inventory

    Quantitation of human and veterinary pharmaceuticals in environmental matrices has resulted in pharmaceuticals in the environment receiving unprecedented attention from the scientific community. Aquatic hazard assessments often use quantitative structure activity relationships an...

  2. Risks to aquatic organisms posed by human pharmaceutical use

    EPA Science Inventory

    In order to help prioritize future research efforts within the US, risks associated with exposure to human prescription pharmaceutical residues in wastewater were estimated from marketing and pharmacological data. Masses of 371 active pharmaceutical ingredients (APIs) dispensed ...

  3. Predicting variability of aquatic concentrations of human pharmaceuticals

    EPA Science Inventory

    Potential exposure to active pharmaceutical ingredients (APIs) in the aquatic environment is a subject of ongoing concern. We recently estimated maximum likely potency-normalized exposure rates at the national level for several hundred commonly used human prescription pharmaceut...

  4. 99M-technetium labeled macroaggregated human serum albumin pharmaceutical

    DOEpatents

    Winchell, Harry S.; Barak, Morton; Van Fleet, III, Parmer

    1977-05-17

    A reagent comprising macroaggregated human serum albumin having dispersed therein particles of stannous tin and a method for instantly making a labeled pharmaceutical therefrom, are disclosed. The labeled pharmaceutical is utilized in organ imaging.

  5. The Pharmaceutical Care Movement: Opportunities for Collaboration.

    ERIC Educational Resources Information Center

    Temple, Thomas R.

    1996-01-01

    Areas in which pharmacy educators and practitioners can collaborate to hasten pharmacy curriculum development are outlined, including: state and regional centers for operationalizing the pharmaceutical care concept; training, formal resource programs for pharmacists; research advisory boards; public education; links with medical community;…

  6. Who Dispenses Pharmaceuticals to Children at School?

    ERIC Educational Resources Information Center

    Francis, Elaine Esielionis; And Others

    1996-01-01

    This study examined how pharmaceuticals were dispensed in one Florida county's public elementary, middle, and high schools and in six private schools. Surveys indicated that of 28,134 children surveyed, 1,016 received 5,411 doses of medication from school personnel, who were not necessarily health care personnel. Methylphenidate was the most…

  7. New pharmaceuticals in inflammatory bowel disease.

    PubMed

    Łodyga, Michał; Eder, Piotr; Bartnik, Witold; Gonciarz, Maciej; Kłopocka, Maria; Linke, Krzysztof; Małecka-Panas, Ewa; Radwan, Piotr; Rydzewska, Grażyna

    2015-01-01

    This paper complements the previously published Guidelines of the Working Group of the Polish Society of Gastroenterology and former National Consultant in Gastroenterology regarding the management of patients with Crohn's disease and ulcerative colitis. Attention was focused on the new pharmaceutical recently registered for inflammatory bowel disease treatment.

  8. Drug Information Residency Rotation with Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Cramer, Richard L.

    1986-01-01

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

  9. Pharmaceuticals and Hormones in the Environment

    EPA Science Inventory

    Some of the earliest initial reports from Europe and the United States demonstrated that a variety of pharmaceuticals and hormones could be found in surface waters, source waters, drinking water, and influents and effluents from wastewater treatment plants (WWTPs). It is unknown...

  10. [Alternatives to pharmaceutical distribution and reimbursement].

    PubMed

    Meneu, R

    2002-01-01

    In Spain pharmaceutical distribution is carried out mainly thorugh the 20,000 independent pharmacies located throughout the country. This situation contrasts with that in other countries where other health care providers play a major role in drug dispensation or where pharmacies form part of industrial conglomerates or commercial chains. We describe the pharmaceutical distribution chain in Spain wholesale and through the pharmacies and place particular emphasis on five aspects of relevance when considering alternatives: ownership of the pharmacy and norms of professional service, criteria for setting up a pharmacy, monopoly on dispensing, automatic ageement with the Spanish national health system and reimbursement system. Several alternatives found in comparable countries are described: mail order and on-line distribution, sale of over-the counter pharmaceutical products in establishments other than pharmacies, the estabilishment of pharmaceutical chains, dispensing by providers, the repercussions of electronic prescribing and the possibilities of the still-emerging Pharmacuetical Care. The characteristics of pharmacy reimbursement systems are also reviewed. We recommend modification of limitations on ownership of pharmacies, the establishment of optional agreements between pharmacies and the Spanish national health system and the authorization of alternative or complementary channels of distribution for some products. We propose a mixed model of reimbursement that would include: a) a ficed price for dispensing; b) almost total return of the cost of the product; c) reimbursement for services explicity defined by the financer, and d) the possibility of a selective fixed payment for certain situations depending on the agreed services or a guaranteed minimum income.

  11. Developing Closer Ties with the Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Reid, Gregor; Hoddinott, Susan

    1991-01-01

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

  12. Pharmaceutical Applications of Ion-Exchange Resins

    ERIC Educational Resources Information Center

    Elder, David

    2005-01-01

    The historical uses of ion-exchanged resins and a summary of the basic chemical principles involved in the ion-exchanged process are discussed. Specific applications of ion-exchange are provided that include drug stabilization, pharmaceutical excipients, taste-masking agents, oral sustained-release products, topical products for local application…

  13. Pharmaceutical Education. Bulletin, 1921, No. 11

    ERIC Educational Resources Information Center

    Rudd, Wortley F.

    1921-01-01

    Any history of pharmaceutical education during the two years 1918 to 1920 would be wholly incomplete without a review of the influences, which have brought about the conditions during the period under consideration. In pharmacy, as in medicine and law, the preceptorial system largely prevailed for the first century of pharmacy in the United…

  14. An Interdisciplinary Course in Pharmaceutical Advertising.

    ERIC Educational Resources Information Center

    Grieshaber, Larry D.; And Others

    1980-01-01

    A course in pharmaceutical product merchandising offered at the St. Louis College of Pharmacy incorporated as its three major components the development of a one-page print advertisement, a recorded radio commercial, and a videotape commercial series. Student evaluations were based on performance rather than effort. (MSE)

  15. Pharmaceutical drugs chatter on Online Social Networks.

    PubMed

    Wiley, Matthew T; Jin, Canghong; Hristidis, Vagelis; Esterling, Kevin M

    2014-06-01

    The ubiquity of Online Social Networks (OSNs) is creating new sources for healthcare information, particularly in the context of pharmaceutical drugs. We aimed to examine the impact of a given OSN's characteristics on the content of pharmaceutical drug discussions from that OSN. We compared the effect of four distinguishing characteristics from ten different OSNs on the content of their pharmaceutical drug discussions: (1) General versus Health OSN; (2) OSN moderation; (3) OSN registration requirements; and (4) OSNs with a question and answer format. The effects of these characteristics were measured both quantitatively and qualitatively. Our results show that an OSN's characteristics indeed affect the content of its discussions. Based on their information needs, healthcare providers may use our findings to pick the right OSNs or to advise patients regarding their needs. Our results may also guide the creation of new and more effective domain-specific health OSNs. Further, future researchers of online healthcare content in OSNs may find our results informative while choosing OSNs as data sources. We reported several findings about the impact of OSN characteristics on the content of pharmaceutical drug discussion, and synthesized these findings into actionable items for both healthcare providers and future researchers of healthcare discussions on OSNs. Future research on the impact of OSN characteristics could include user demographics, quality and safety of information, and efficacy of OSN usage.

  16. Pollution prevention in the pharmaceutical industry

    SciTech Connect

    Venkataramani, E.S.

    1995-09-01

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

  17. An Innovative Pharmaceutical Care Practical Course

    ERIC Educational Resources Information Center

    Bulatova, N. R.; Aburuz, S.; Yousef, A. M.

    2007-01-01

    The innovative practical course was developed to improve the students' ability to acquire pharmaceutical care skills. The primary components of the course were in-school training using small group discussions and hospital experience including identification, analysis, prevention and resolution of drug-therapy problems, patient counseling on their…

  18. Deep pharma: psychiatry, anthropology, and pharmaceutical detox.

    PubMed

    Oldani, Michael

    2014-06-01

    Psychiatric medication, or psychotropics, are increasingly prescribed for people of all ages by both psychiatry and primary care doctors for a multitude of mental health and/or behavioral disorders, creating a sharp rise in polypharmacy (i.e., multiple medications). This paper explores the clinical reality of modern psychotropy at the level of the prescribing doctor and clinical exchanges with patients. Part I, Geographies of High Prescribing, documents the types of factors (pharmaceutical-promotional, historical, cultural, etc.) that can shape specific psychotropic landscapes. Ethnographic attention is focused on high prescribing in Japan in the 1990s and more recently in the Upper Peninsula of Michigan, in the US. These examples help to identify factors that have converged over time to produce specific kinds of branded psychotropic profiles in specific locales. Part II, Pharmaceutical Detox, explores a new kind of clinical work being carried out by pharmaceutically conscious doctors, which reduces the number of medications being prescribed to patients while re-diagnosing their mental illnesses. A high-prescribing psychiatrist in southeast Wisconsin is highlighted to illustrate a kind of med-checking taking place at the level of individual patients. These various examples and cases call for a renewed emphasis by anthropology to critically examine the "total efficacies" of modern pharmaceuticals and to continue to disaggregate mental illness categories in the Boasian tradition. This type of detox will require a holistic approach, incorporating emergent fields such as neuroanthropology and other kinds of creative collaborations.

  19. Sectoral shifts and aggregate unemployment

    SciTech Connect

    Loungani, P.

    1986-01-01

    Some recent research has taken the view that sectoral or industry-specific shocks significantly affect aggregate unemployment by increasing the amount of inter-industry labor reallocation required. The empirical evidence for this view rests on the finding that during the 1950s - and again during the 1970s - there was a positive correlation between aggregate unemployment and the dispersion of employment growth rates. This thesis demonstrates that this correlation arises largely because oil price shocks affect both unemployment and the dispersion of employment growth. Once the dispersion due to oil shocks is accounted for, the residual dispersion in employment has very low explanatory power for unemployment. Since the dispersion index does not measure pure sectoral shifts, an alternate measure of dispersion is developed that serves as a better proxy for the amount of inter-industry labor reallocation required each period. Estimates using this measure suggest that, during the 1950s, temporary increases in the relative price of oil were responsible for generating the observed correlation. On the other hand, sectoral shifts were important during the 1970s; in particular, the 1973 oil price increase has had significant reallocative effects on the economy. This contention is subjected to further tests by looking at the time-series behavior of employment in durable-goods industries and also by following the inter-industry movements of workers over time through the use of panel data.

  20. Pharmaceuticals as Groundwater Tracers - Applications and Limitations

    NASA Astrophysics Data System (ADS)

    Scheytt, T. J.; Mersmann, P.; Heberer, T.

    2003-12-01

    Pharmaceutically active substances and metabolites are found at concentrations up to the microgram/L-level in groundwater samples from the Berlin (Germany) area and from several other places world wide. Among the compounds detected in groundwater are clofibric acid, propyphenazone, diclofenac, ibuprofen, and carbamazepine. Clofibric acid, the active metabolite of clofibrate and etofibrate (blood lipid regulators) is detected in groundwater at maximum concentrations of 7300 ng/L. Among the most important input paths of drugs are excretion and disposal into the sewage system. Groundwater contamination is likely to be due to leaky sewage systems, influent streams, bank filtration, and irrigation with effluent water from sewage treatment plants. There are no known natural sources of the above mentioned pharmaceuticals. The use of pharmaceuticals as tracers may include: (a) Quantification of infiltration from underground septic tanks (b) Detection of leaky sewage systems / leaky sewage pipes (c) Estimation of the effectiveness of sewage treatment plants (d) Identification of transport pathways of other organic compounds (e) Quantification of surface water / groundwater interaction (f) Characterization of the biodegradation potential. The use of pharmaceuticals as tracers is limited by variations in input. These variations depend on the amount of drugs prescribed and used in the study area, the social structure of the community, the amount of hospital discharge, and temporal concentration variations. Furthermore, the analysis of trace amounts of pharmaceuticals is sophisticated and expensive and may therefore limit the applicability of pharmaceuticals as tracers. Finally, the transport and degradation behavior of pharmaceuticals is not fully understood. Preliminary experiments in the laboratory were conducted using sediment material and groundwater from the Berlin area to evaluate the transport and sorption behavior of selected drugs. Results of the column experiments

  1. Polymer therapeutics: Top 10 selling pharmaceuticals - what next?

    PubMed

    Duncan, Ruth

    2014-09-28

    At the time of the first issue of the Journal of Controlled Release (JCR), polymeric drugs, polymer-drug and protein conjugates and block copolymer micelles carrying bound drugs, i.e. polymer therapeutics, were still regarded as scientific curiosities with little or no prospect of generating practical to use medicines. How this perception has changed. Many major Pharma now have R&D programmes in this area and in 2013 two polymer therapeutics, Copaxone and Neulasta, are featured in the Top 10 US pharmaceutical sales list. Although there are a growing number of marketed products (e.g. PEGylated proteins, a PEG-aptamer and oral polymeric sequestrants), and the first follow-on (generic products) are emerging, the first polymer-drug conjugates and block copolymer micelle products (as covalent conjugates) have yet to enter routine clinical use. Industrial familiarity and recent advances in the underpinning scientific disciplines will no doubt accelerate the transfer of polymer therapeutics into clinically useful medicines and imaging agents. This short personal perspective reflects on the current status of polymer therapeutics and the future opportunities to improve their successful translation. It adds to recent and historical reviews that comprehensively document the evolution of the field since JCR was born.

  2. Environmental risk assessment of human pharmaceuticals in Denmark after normal therapeutic use.

    PubMed

    Stuer-Lauridsen, F; Birkved, M; Hansen, L P; Lützhøft, H C; Halling-Sørensen, B

    2000-04-01

    An environmental risk assessment is presented for the 25 most used pharmaceuticals in the primary health sector in Denmark. Predicted environmental concentrations (PECs) for the aquatic environment were calculated using conservative assumptions and all PECs exceeded 1 ng/l. Measured concentrations were in general within a factor of 2-5 of PECs and ranged from approximately 0.5 ng/l to 3 micrograms/l for nine of the pharmaceuticals reported in literature. The calculation of predicted no-effect concentration (PNEC) based on aquatic ecotoxicity data was possible for six of the pharmaceuticals. PEC/PNEC ratio exceeded one for ibuprofen, acetylsalicylic acid, and paracetamol. For estrogens the PEC/PNEC ratio approached one when non-standard test was used. The ratio was below one for estrogens (standard test), diazepam and digoxin. For the terrestrial compartment, toxicity data were not available, and no assessment was carried out. Comparisons of predicted concentrations of furosemide, ibuprofen, oxytetracycline and ciprofloxacin in sludge based on either preliminary experimental sludge-water partition coefficients (Kd), octanol-water coefficients (Kow) or acid-base constants (pKa) revealed large variations.

  3. The integrated assessment of occupational risks in a pharmaceutical manufacturing plant.

    PubMed

    Attaianese, Erminia; Duca, Gabriella

    2012-01-01

    Pharmaceutical plants are usually characterized by workplaces with quality levels generally higher than in other manufactoring sectors since healthcare products need to be produced in special conditions, keeping under a strong control hygiene, chemical and biological contaminants, and giving a particular emphasis on equipment maintenance. Limited physical work load, a low rate of injuries and work related pathologies together with a high level of quality process control contribute to consider pharma work conditions as generally light and safe. In this kind of contexts risk assessment cannot be based on factors individually considered, neither work load can be essentially measured on material handling and physical effort. Risk assessment and work environment improvements, on the contrary, have to be studied by an integrated view point. The paper presents methodologies and results of the applied research project IntegrARE (INTEGRated Assessment of Risks within Ergonomics) aimed at analyzing, in a big solid forms pharmaceutical plant, three different risk categories - architectural, ergonomic and active pharmaceutical ingredients risks - in order to highlight possible interactions on workers health, safety and wellbeing. After a detailed risk situations survey, singularly analyzed by a number of ad-hoc procedures, the study presents a methodology for integrated assessment of risks, aimed at identifying and evaluating integrated effects increasing or triggering risk situations for workers.

  4. An overview of pharmaceutical cocrystals as intellectual property.

    PubMed

    Trask, Andrew V

    2007-01-01

    This review article focuses on the interaction among certain scientific, legal, and regulatory aspects of pharmaceutical crystal forms. The article offers an analysis of pharmaceutical cocrystals as patentable inventions by drawing upon recent scientific developments in the field. Several potential commercial advantages of pharmaceutical cocrystals are highlighted, and a number of recent court decisions involving salient issues are summarized. The article provides an outlook on how the developing field of cocrystallization may impact the pharmaceutical intellectual property landscape.

  5. Is the pharmaceutical market in Bulgaria innovative?

    PubMed

    Stoimenova, A; Stankova, M; Samev, K; Petrova, G

    2003-09-01

    After the turn to market oriented economy a lot of drugs were authorized for sale in the East European countries. Because of the limited resources of these countries, mainly generic or brand generic products were licensed. The number of the patented drugs on the market could be used as measure of the market attractiveness to the R&D producers. The study shows the analysis of the innovativeness of the Bulgarian drug market comparing the registration and the patient activity of the producers. The number of the authorized products for five years period (1990-2000) and share of the patented products were investigated. During the observed period the number of newly authorized pharmaceuticals increased almost seven times from 800 (650 INN) to 6000 (2000 INN) dosage forms. The prevailing part of the newly registered drugs was found to be brand generics and possess only trade name protection. The share of drugs that are patented is less than five percent of all newly registered medicines, and among the fifty most commonly prescribed and sold medicines between 1996-2000, only 0.5 percent of drugs were patented. Obviously the Bulgarian pharmaceutical market is very competitive but not that attractive for most of the R&D producers. In general the registration of the patent protected products is increasing during the years and especially after harmonization of the related legislation with the EU requirements. The patent activity of the pharmaceutical companies regarding newly authorized drugs is influenced by the structure of morbidity and population. During the last two years the patent activity is increasing and is oriented mainly towards the protection of newly authorized drugs or pharmaceutical forms and obligatory registration of trademarks for the privatized Bulgarian pharmaceutical manufacturers.

  6. Effective executive management in the pharmaceutical industry.

    PubMed

    Tran, Hoang; Kleiner, Brian H

    2005-01-01

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

  7. Interventions to reduce corruption in the health sector

    PubMed Central

    Gaitonde, Rakhal; Oxman, Andrew D; Okebukola, Peter O; Rada, Gabriel

    2016-01-01

    doctors from accepting any form of benefits from the pharmaceutical industry may improve doctors' attitudes about the influence of pharmaceutical companies on their choice of medicines (low certainty of the evidence). A study in the USA, evaluated the effects of introducing a law that required pharmaceutical companies to report the gifts they gave to healthcare workers. Another study in the USA evaluated the effects of a variety of internal control mechanisms used by community health centres to stop corruption. The effects of these strategies is unclear because the evidence was of very low certainty. Authors' conclusions There is a paucity of evidence regarding how best to reduce corruption. Promising interventions include improvements in the detection and punishment of corruption, especially efforts that are coordinated by an independent agency. Other promising interventions include guidelines that prohibit doctors from accepting benefits from the pharmaceutical industry, internal control practices in community health centres, and increased transparency and accountability for co-payments combined with reduced incentives for informal payments. The extent to which increased transparency alone reduces corruption is uncertain. There is a need to monitor and evaluate the impacts of all interventions to reduce corruption, including their potential adverse effects. Interventions to reduce corruption in the health sector What is the aim of this review? The aim of this Cochrane review is to assess the effectiveness of strategies to reduce corruption in the health sector. Cochrane researchers searched for all potentially relevant studies, and found nine studies that met their criteria. Key messages The review suggests that some strategies to fight corruption in the health sector can have an effect on corruption. These strategies include the use of independent agencies to investigate and punish corruption, telling healthcare workers that they are not allowed to accept payments from

  8. Energy Sector Impacts and Opportunities

    NASA Astrophysics Data System (ADS)

    Newmark, R. L.; Macknick, J.; Martinez, A.; Hallett, K. C.

    2011-12-01

    The power sector is the largest user of freshwater in the U.S. The dominant use of water in power plants is for steam cycle cooling. The current portfolio of electricity generating technologies in the U.S. has highly regionalized and technology-specific requirements for water. Certain areas employ once-through cooling technologies with high withdrawals and low consumptive uses, whereas other areas employ recirculating cooling technologies with relatively low withdrawals but high consumptive uses. As water availability differs widely throughout the nation, assessments of water withdrawal and consumption impacts from the power sector must have a high geographic resolution and consider regional differences. The U.S. electricity portfolio is likely to evolve in coming years, shaped by various energy policies and economic drivers on both the national and regional level, which will impact power sector water demands. It is likely that the U.S. will continue to decarbonize its electricity industry, leading to more low-carbon technologies. However, many low-carbon technologies, such as coal with carbon capture and storage, nuclear, and concentrated solar power, can use more water than the current electricity portfolio average. National- and state-level water policies have been proposed (and enacted) that affect cooling system choices for power plants, with resulting implications for water use as well as power plant installed and operating costs and reliability. Energy policy analyses that do not consider power plant cooling system impacts may miss an important component power plant siting decisions. Similarly, water policies that do not take into consideration potential impacts on power plant operations or comprehensive regional water budget impacts may have deleterious effects on the energy industry. Analysis of future energy scenarios that incorporate technology options and constraints as well as different policies can provide useful insights about likely changes to both

  9. Business and AIDS: sectoral challenges and opportunities.

    PubMed

    Weston, Mark D; Churchyard, Gavin J; Mametja, David; McIntyre, James A; Randera, Fazel

    2007-07-01

    The Business and AIDS think tank held in Durban, South Africa, in June 2006, included a discussion of the policies with which different types of employer could address HIV/AIDS in southern Africa. Breakout groups discussed the role of large and small private sector firms, the public sector, and parastatal organizations. They made recommendations for policies, programmes and future research for each sector.

  10. 42 CFR 482.25 - Condition of participation: Pharmaceutical services.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Condition of participation: Pharmaceutical services... Hospital Functions § 482.25 Condition of participation: Pharmaceutical services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by...

  11. 42 CFR 482.25 - Condition of participation: Pharmaceutical services.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Condition of participation: Pharmaceutical services... Hospital Functions § 482.25 Condition of participation: Pharmaceutical services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by...

  12. A review of pharmaceutical policies in response to economic crises and sanctions.

    PubMed

    Kheirandish, Mehrnaz; Rashidian, Arash; Kebriaeezade, Abbas; Cheraghali, Abdol Majid; Soleymani, Fatemeh

    2015-01-01

    An economic crisis has been defined as a situation in which the scale of a country's economy becomes smaller in a period of time. Economic crises happen for various reasons, including economic sanctions. Economic crises in a country may affect national priorities for investment and expenditure and reduce available resources, and hence may affect the health care sector including access to medicines. We reviewed the pharmaceutical policies that the countries adopted in order to mitigate the potential negative effects on access to medicines. We reviewed published reports and articles after conducting a comprehensive search of the PubMed and the Google Scholar. After extracting relevant data from the identified articles, we used the World Health Organization (WHO) access to medicines framework as a guide for the categorization of the policies. We identified a total of 40 studies, of which 10 reported the national pharmaceutical policies adopted to reduce the negative impacts of economic crises on access to medicines in high-income and middle-income countries. We identified 89 policies adopted in the 11 countries and categorized them into 12 distinct policy directions. Most of the policies focused on financial aspects of the pharmaceutical sector. In some cases, countries adopted policies that potentially had negative effects on access to medicines. Only Italy had adopted policies encompassing all four accesses to medicine factors recommended by the WHO. While the countries have adopted many seemingly effective policies, little evidence exists on the effectiveness of these policies to improve access to medicines at a time of an economic crisis.

  13. A review of pharmaceutical policies in response to economic crises and sanctions

    PubMed Central

    Kheirandish, Mehrnaz; Rashidian, Arash; Kebriaeezade, Abbas; Cheraghali, Abdol Majid; Soleymani, Fatemeh

    2015-01-01

    An economic crisis has been defined as a situation in which the scale of a country's economy becomes smaller in a period of time. Economic crises happen for various reasons, including economic sanctions. Economic crises in a country may affect national priorities for investment and expenditure and reduce available resources, and hence may affect the health care sector including access to medicines. We reviewed the pharmaceutical policies that the countries adopted in order to mitigate the potential negative effects on access to medicines. We reviewed published reports and articles after conducting a comprehensive search of the PubMed and the Google Scholar. After extracting relevant data from the identified articles, we used the World Health Organization (WHO) access to medicines framework as a guide for the categorization of the policies. We identified a total of 40 studies, of which 10 reported the national pharmaceutical policies adopted to reduce the negative impacts of economic crises on access to medicines in high-income and middle-income countries. We identified 89 policies adopted in the 11 countries and categorized them into 12 distinct policy directions. Most of the policies focused on financial aspects of the pharmaceutical sector. In some cases, countries adopted policies that potentially had negative effects on access to medicines. Only Italy had adopted policies encompassing all four accesses to medicine factors recommended by the WHO. While the countries have adopted many seemingly effective policies, little evidence exists on the effectiveness of these policies to improve access to medicines at a time of an economic crisis. PMID:26312250

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

    PubMed

    Schmid, Esther F; Smith, Dennis A

    2005-08-01

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

  15. Risk perception as a driver for risk management policies

    NASA Astrophysics Data System (ADS)

    Carmona, María; Mañez, María

    2016-04-01

    Risk is generally defined as the "combination of the probability of the occurrence of an event and its negative consequences" ( UNISDR, 2009). However, the perception of a risk differs among cultures regarding different features such as the context,causes, benefits or damage. Risk perception is the subjective valuation of the probability of an event happening and how concerned individuals or groups are with the consequences (Sjöberg, 2004). Our study is based on an existing framework for risk perception (Rehn and Rohrmann, 2000). We analyse the characteristics of the risk perception regarding extreme events (e.g.droughts) and how the perception of the group drives the action to manage the risk. We do this to achieve an overview of the conditions that let stakeholders join each other to improve risk management especially when governments are not reacting properly. For our research, attention is paid on risk perception of Multi-Sector Partnerships not taking into account the individual level of risk perception. We focus on those factors that make risk management effective and increase resilience. Multi-Sector Partnerships, considered as significant governance structures for risk management, might contribute to reduce vulnerability in prone areas to natural hazards and disasters. The Multi-Sector Partnerships used for our research are existing partnerships identified in the cases studies of the European project ENHANCE. We implement a survey to analyse the perception of risk in the case studies. That survey is based on the Cultural Theory (Douglas and Wildavsky, 1982)and the Protection Motivation Theory (Rogers, 1975). We analyse the results using the Qualitative-Comparative Analysis proposed by Ragin in 1987. The results show the main characteristics of a risk culture that are beneficial to manage a risk. Those characteristics are shaped by the perception of risk of the people involved in the partnership, which in turn shapes their risk management. Nevertheless, we

  16. Behavior of selected pharmaceuticals in topsoil of Greyic Phaeozem

    NASA Astrophysics Data System (ADS)

    Kodesova, Radka; Klement, Ales; Kocarek, Martin; Fer, Miroslav; Golovko, Oksana; Grabic, Roman; Jaksik, Ondrej

    2014-05-01

    It has been documented in several studies that soil may be contaminated by human or veterinary pharmaceuticals. Some of pharmaceutical ingredient may be retained in soils. The rest can be transported to the surface and groundwater through surface runoff and infiltration. Mobility of contaminants in soils is dependent on many soil and pharmaceutical properties (e.g. pharmaceutical adsorption on soil particles and pharmaceutical degradation). The goals of this study were: (1) to measure adsorption isotherms of selected pharmaceuticals in one soil; (2) to evaluate degradation of selected pharmaceuticals in this soil, and (3) to evaluate impact of applied pharmaceuticals on biological activity in soil, which influences pharmaceutical decomposition. Batch sorption tests were performed for 7 selected pharmaceuticals (beta blockers Atenolol and Metoprolol, anticonvulsant Carbamazepin, and antibiotics Clarithromycin, Clindamycin, Trimetoprim and Sulfamethoxazol) and one soil (topsoil of Greyic Phaeozem from Čáslav). The same concentrations (0.5, 1, 2.5, 5 and 10 mg/l) were used for almost all pharmaceuticals except Clarithromycin (0.033, 0.08, 0.165, 0.25, 0.33 mg/l). The Freundlich equations were used to describe adsorption isotherms. Degradation of all 7 pharmaceuticals was also studied. Solutes of different pharmaceuticals (concentration of 8.3 mg/l) were added into the plastic bottles (one pharmaceutical per bottle) with soil. Concentrations of pharmaceuticals remaining in soil 1, 2, 5, 12, 23, 40 and 61 days after the pharmaceutical application were analyzed. Colony forming unites were evaluated to describe microbial activity in time affected by different pharmaceuticals. Adsorption of studied pharmaceuticals on soil particles decreasing as follows: Clarithromycin, Trimetoprim, Metoprolol, Clindamycin, Atenolol, Carbamazepin, Sulfamethoxazol. Degradation rates in some degree reflected adsorption of studied pharmaceuticals on soil particles and increased with

  17. Jordanian pharmaceutical companies: are their marketing efforts paying off?

    PubMed

    Al-Shaikh, Mustafa S; Torres, Ivonne M; Zuniga, Miguel A; Ghunaim, Ayman

    2011-04-01

    The pharmaceuticals industry is one of the main industries in Jordan. Jordanian pharmaceuticals rank third in the export industry of this country. This study aims to examine the strengths that Jordanian pharmaceutical companies have, which, in turn, form their competitiveness base. In addition, this study aims to identify their weaknesses and the effects of marketing their products in the local market. What is the relationship between Jordanian pharmaceutical product quality, price and value, and the competitiveness of pharmaceutical companies in the local market? Our study aims to answer this and other questions. Our results and practical implications are discussed.

  18. The effect of pharmaceutical benefits managers: is it being evaluated?

    PubMed

    Schulman, K A; Rubenstein, L E; Abernethy, D R; Seils, D M; Sulmasy, D P

    1996-05-15

    Over the last decade, the number of pharmaceutical benefits managers has increased, and their influence has expanded rapidly. These managers now provide prescription drug coverage to more than 100 million Americans. The effect of pharmaceutical benefits managers on health care delivery remains unclear. We review the development of these organizations, their current role in the delivery of pharmaceutical therapies to patients, and their relationship with pharmaceutical manufacturers. We discuss potential advantages and disadvantages of pharmaceutical benefits manager practices and suggest ways in which these organizations can be made more accountable to the employer groups that hire them.

  19. Dynamically Evolving Sectors for Convective Weather Impact

    NASA Technical Reports Server (NTRS)

    Drew, Michael C.

    2010-01-01

    A new strategy for altering existing sector boundaries in response to blocking convective weather is presented. This method seeks to improve the reduced capacity of sectors directly affected by weather by moving boundaries in a direction that offers the greatest capacity improvement. The boundary deformations are shared by neighboring sectors within the region in a manner that preserves their shapes and sizes as much as possible. This reduces the controller workload involved with learning new sector designs. The algorithm that produces the altered sectors is based on a force-deflection mesh model that needs only nominal traffic patterns and the shape of the blocking weather for input. It does not require weather-affected traffic patterns that would have to be predicted by simulation. When compared to an existing optimal sector design method, the sectors produced by the new algorithm are more similar to the original sector shapes, resulting in sectors that may be more suitable for operational use because the change is not as drastic. Also, preliminary results show that this method produces sectors that can equitably distribute the workload of rerouted weather-affected traffic throughout the region where inclement weather is present. This is demonstrated by sector aircraft count distributions of simulated traffic in weather-affected regions.

  20. Sectoral approaches to improve regional carbon budgets

    SciTech Connect

    Smith, Pete; Nabuurs, Gert-Jan; Marland, Gregg

    2008-06-01

    Humans utilise about 40% of the earth s net primary production (NPP) but the products of this NPP are often managed by different sectors, with timber and forest products managed by the forestry sector and food and fibre products from croplands and grasslands managed by the agricultural sector. Other significant anthropogenic impacts on the global carbon cycle include human utilization of fossil fuels and impacts on less intensively managed systems such as peatlands, wetlands and permafrost. A great deal of knowledge, expertise and data is available within each sector. We describe the contribution of sectoral carbon budgets to our understanding of the global carbon cycle. Whilst many sectors exhibit similarities for carbon budgeting, some key differences arise due to differences in goods and services provided, ecology, management practices used, landmanagement personnel responsible, policies affecting land management, data types and availability, and the drivers of change. We review the methods and data sources available for assessing sectoral carbon budgets, and describe some of key data limitations and uncertainties for each sector in different regions of the world. We identify the main gaps in our knowledge/data, show that coverage is better for the developed world for most sectors, and suggest how sectoral carbon budgets could be improved in the future. Research priorities include the development of shared protocols through site networks, a move to full carbon accounting within sectors, and the assessment of full greenhouse gas budgets.

  1. Trust and the regulation of pharmaceuticals: South Asia in a globalised world

    PubMed Central

    2011-01-01

    Background Building appropriate levels of trust in pharmaceuticals is a painstaking and challenging task, involving participants from different spheres of life, including producers, distributors, retailers, prescribers, patients and the mass media. Increasingly, however, trust is not just a national matter, but involves cross-border flows of knowledge, threats and promises. Methods Data for this paper comes from the project 'Tracing Pharmaceuticals in South Asia', which used ethnographic fieldwork and qualitative interviews to compared the trajectories of three pharmaceuticals (Rifampicin, Oxytocin and Fluoxetine) from producer to patient in three sites (north India, West Bengal and Nepal) between 2005-08. Results We argue that issues of trust are crucial in reducing the likelihood of appropriate use of medicines. Unlike earlier discussions of trust, we suggest that trust contexts beyond the patient-practitioner relationship are important. We illustrate these arguments through three case studies: (i) a conflict over ethics in Nepal, involving a suggested revised ethical code for retailers, medical representatives, producers and prescribers; (ii) disputes over counterfeit, fake, substandard and spurious medicines, and quality standards in Indian generic companies, looking particularly at the role played by the US FDA; and (iii) the implications of lack of trust in the DOTS programmes in India and Nepal for the relationships among patients, government and the private sector. Conclusions We conclude that the building of trust is a necessary but always vulnerable and contingent process. While it might be desirable to outline steps that can be taken to build trust, the range of conflicting interests in the pharmaceutical field make feasible solutions hard to implement. PMID:21529358

  2. Macroscopic theory of dark sector

    NASA Astrophysics Data System (ADS)

    Meierovich, Boris

    A simple Lagrangian with squared covariant divergence of a vector field as a kinetic term turned out an adequate tool for macroscopic description of the dark sector. The zero-mass field acts as the dark energy. Its energy-momentum tensor is a simple additive to the cosmological constant [1]. Space-like and time-like massive vector fields describe two different forms of dark matter. The space-like massive vector field is attractive. It is responsible for the observed plateau in galaxy rotation curves [2]. The time-like massive field displays repulsive elasticity. In balance with dark energy and ordinary matter it provides a four parametric diversity of regular solutions of the Einstein equations describing different possible cosmological and oscillating non-singular scenarios of evolution of the universe [3]. In particular, the singular big bang turns into a regular inflation-like transition from contraction to expansion with the accelerate expansion at late times. The fine-tuned Friedman-Robertson-Walker singular solution corresponds to the particular limiting case at the boundary of existence of regular oscillating solutions in the absence of vector fields. The simplicity of the general covariant expression for the energy-momentum tensor allows to analyse the main properties of the dark sector analytically and avoid unnecessary model assumptions. It opens a possibility to trace how the additional attraction of the space-like dark matter, dominating in the galaxy scale, transforms into the elastic repulsion of the time-like dark matter, dominating in the scale of the Universe. 1. B. E. Meierovich. "Vector fields in multidimensional cosmology". Phys. Rev. D 84, 064037 (2011). 2. B. E. Meierovich. "Galaxy rotation curves driven by massive vector fields: Key to the theory of the dark sector". Phys. Rev. D 87, 103510, (2013). 3. B. E. Meierovich. "Towards the theory of the evolution of the Universe". Phys. Rev. D 85, 123544 (2012).

  3. Herbal remedy clinical trials in the media: a comparison with the coverage of conventional pharmaceuticals

    PubMed Central

    Bubela, Tania; Boon, Heather; Caulfield, Timothy

    2008-01-01

    Background This study systematically compares newspaper coverage of clinical trials for herbal remedies, a popular type of complementary and alternative medicine, with clinical trials for pharmaceuticals using a comparative content analysis. This is a timely inquiry given the recognized importance of the popular press as a source of health information, the complex and significant role of complementary and alternative medicine in individual health-care decisions, and the trend toward evidence-based research for some complementary and alternative medical therapies. We searched PubMed for clinical trials, Lexis/Nexis for newspaper articles in the UK, US, Australia/New Zealand, and Factiva for Canadian newspaper articles from 1995 to 2005. We used a coding frame to analyze and compare 48 pharmaceutical and 57 herbal remedy clinical trials as well as 201 pharmaceutical and 352 herbal remedy newspaper articles. Results Herbal remedy clinical trials had similar Jadad scores to pharmaceutical trials but were significantly smaller and of shorter duration. The trials were mostly studies from Western countries and published in high-ranking journals. The majority of pharmaceutical (64%) and herbal remedy (53%) clinical trials had private sector funding involvement. A minority declared further author conflicts of interest. Newspaper coverage of herbal remedy clinical trials was more negative than for pharmaceutical trials; a result only partly explained by the greater proportion of herbal remedy clinical trials reporting negative results (P = 0.0201; χ2 = 7.8129; degrees of freedom = 2). Errors of omission were common in newspaper coverage, with little reporting of dose, sample size, location, and duration of the trial, methods, trial funding, and conflicts of interest. There was an under-reporting of risks, especially for herbal remedies. Conclusion Our finding of negative coverage of herbal remedy trials is contrary to the positive trends in most published research based

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

    PubMed

    Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

    2016-12-01

    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 employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

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

    PubMed Central

    Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

    2016-01-01

    Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations. PMID:28101455

  6. The creation of the health consumer: challenges on health sector regulation after managed care era

    PubMed Central

    2011-01-01

    Background We utilized our previous studies analyzing the reforms affecting the health sector developed in the 1990s by financial groups to frame the strategies implemented by the pharmaceutical industry to regain market positions and to understand the challenges that regulatory agencies are confronting. Methods We followed an analytical approach for analyzing the process generated by the disputes between the financial groups and the pharmaceutical corporations and the challenges created to governmental regulation. We analyzed primary and secondary sources using situational and discourse analyses. We introduced the concepts of biomedicalization and biopedagogy, which allowed us to analyze how medicalization was radicalized. Results In the 1990s, structural adjustment policies facilitated health reforms that allowed the entrance of multinational financial capital into publicly-financed and employer-based insurance. This model operated in contraposition to the interests of the medical industrial complex, which since the middle of the 1990s had developed silent reforms to regain authority in defining the health-ill-care model. These silent reforms radicalized the medicalization. Some reforms took place through deregulatory processes, such as allowing direct-to-consumer advertisements of prescription drugs in the United States. In other countries different strategies were facilitated by the lack of regulation of other media such as the internet. The pharmaceutical industry also has had a role in changing disease definitions, rebranding others, creating new ones, and pressuring for approval of treatments to be paid by public, employer, and private plans. In recent years in Brazil there has been a substantial increase in the number of judicial claims demanding that public administrations pay for new treatments. Conclusions We found that the dispute for the hegemony of the health sector between financial and pharmaceutical companies has deeply transformed the sector

  7. Patent indicators: a window to pharmaceutical market success.

    PubMed

    Guo, Yang; Hu, Yuanjia; Zheng, Mingli; Wang, Yitao

    2013-07-01

    Pharmaceutical success in the market is the best reward for pharmaceutical investors undergoing the lengthy, costly and risky process of pharmaceutical Research and Development (R&D). Drugs with high market revenues trigger fierce competition between pharmaceutical enterprises, as is demonstrated by the increasing Mergers & Acquisitions (M&A) cases focusing on seizing the best-selling products. On the other hand, patents, as the best shield for innovative drugs against generic drugs, become a powerful weapon for pharmaceutical enterprises to win the substantial returns generated by market exclusivity. Patents seem to be directly responsible for the commercial success of new medicines. In this context, it is of great significance to find out the empirical associations between pharmaceutical commercial success and patents. By comprehensively analysing 127 drugs marketed in the USA and their 621 American patents, this article identifies the evidence to link various patent indicators with pharmaceutical sales in actual market.

  8. External referencing and pharmaceutical price negotiation.

    PubMed

    Garcia Mariñoso, Begoña; Jelovac, Izabela; Olivella, Pau

    2011-06-01

    External referencing (ER) imposes a price cap for pharmaceuticals, based on prices of identical or comparable products in foreign countries. Suppose a foreign country (F) negotiates prices with a pharmaceutical firm, whereas a home country (H) can either negotiate prices independently or implement ER, based on the foreign price. We show that country H prefers ER if copayments in H are relatively high. This preference is reinforced when H's population is small. Irrespective of relative country sizes, ER by country H harms country F. Our model is inspired by the wide European experience with this cost-containment policy. Namely, in Europe, drug authorization and price negotiations are carried out by separate agencies. We confirm our main results in two extensions. The first one allows for therapeutic competition between drugs. In the second one, drug authorization and price negotiation take place in a single agency.

  9. Private versus social incentives for pharmaceutical innovation.

    PubMed

    González, Paula; Macho-Stadler, Inés; Pérez-Castrillo, David

    2016-12-01

    We provide a theoretical framework to contribute to the current debate regarding the tendency of pharmaceutical companies to direct their R&D toward marketing products that are "follow-on" drugs of already existing drugs, rather than toward the development of breakthrough drugs. We construct a model with a population of patients who can be treated with drugs that are horizontally and vertically differentiated. In addition to a pioneering drug, a new drug can be marketed as the result of an innovative process. We analyze physician prescription choices and the optimal pricing decision of an innovative firm. We also characterize the incentives of the innovative firm to conduct R&D activities, disentangling the quest for breakthrough drugs from the firm effort to develop follow-on drugs. Our results offer theoretical support for the conventional wisdom that pharmaceutical firms devote too many resources to conducting R&D activities that lead to incremental innovations.

  10. Chitosan Modification and Pharmaceutical/Biomedical Applications

    PubMed Central

    Zhang, Jiali; Xia, Wenshui; Liu, Ping; Cheng, Qinyuan; Tahirou, Talba; Gu, Wenxiu; Li, Bo

    2010-01-01

    Chitosan has received much attention as a functional biopolymer for diverse applications, especially in pharmaceutics and medicine. Our recent efforts focused on the chemical and biological modification of chitosan in order to increase its solubility in aqueous solutions and absorbability in the in vivo system, thus for a better use of chitosan. This review summarizes chitosan modification and its pharmaceutical/biomedical applications based on our achievements as well as the domestic and overseas developments: (1) enzymatic preparation of low molecular weight chitosans/chitooligosaccharides with their hypocholesterolemic and immuno-modulating effects; (2) the effects of chitin, chitosan and their derivatives on blood hemostasis; and (3) synthesis of a non-toxic ion ligand—D-Glucosaminic acid from Oxidation of D-Glucosamine for cancer and diabetes therapy. PMID:20714418

  11. Multifaceted role of clay minerals in pharmaceuticals

    PubMed Central

    Khurana, Inderpreet Singh; Kaur, Satvinder; Kaur, Harpreet; Khurana, Rajneet Kaur

    2015-01-01

    The desirable physical and physiochemical properties of clay minerals have led them to play a substantial role in pharmaceutical formulations. Clay minerals like kaolin, smectite and palygorskite-sepiolite are among the world's most valuable industrial minerals and of considerable importance. The elemental features of clay minerals which caused them to be used in pharmaceutical formulations are high specific area, sorption capacity, favorable rheological properties, chemical inertness, swelling capacity, reactivity to acids and inconsiderable toxicity. Of course, these are highly cost effectual. This special report on clay minerals provides a bird's eye view of the chemical composition and structure of these minerals and their influence on the release properties of active medicinal agents. Endeavor has been made to rope in myriad applications depicting the wide acceptability of these clay minerals. PMID:28031881

  12. Combinatorial nanodiamond in pharmaceutical and biomedical applications.

    PubMed

    Lim, Dae Gon; Prim, Racelly Ena; Kim, Ki Hyun; Kang, Eunah; Park, Kinam; Jeong, Seong Hoon

    2016-11-30

    One of the newly emerging carbon materials, nanodiamond (ND), has been exploited for use in traditional electric materials and this has extended into biomedical and pharmaceutical applications. Recently, NDs have attained significant interests as a multifunctional and combinational drug delivery system. ND studies have provided insights into granting new potentials with their wide ranging surface chemistry, complex formation with biopolymers, and combination with biomolecules. The studies that have proved ND inertness, biocompatibility, and low toxicity have made NDs much more feasible for use in real in vivo applications. This review gives an understanding of NDs in biomedical engineering and pharmaceuticals, focusing on the classified introduction of ND/drug complexes. In addition, the diverse potential applications that can be obtained with chemical modification are presented.

  13. Raman spectroscopy in pharmaceutical product design.

    PubMed

    Paudel, Amrit; Raijada, Dhara; Rantanen, Jukka

    2015-07-15

    Almost 100 years after the discovery of the Raman scattering phenomenon, related analytical techniques have emerged as important tools in biomedical sciences. Raman spectroscopy and microscopy are frontier, non-invasive analytical techniques amenable for diverse biomedical areas, ranging from 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.

  14. Rosmarinic Acid--Pharmaceutical and Clinical Aspects.

    PubMed

    Amoah, Solomon K S; Sandjo, Louis P; Kratz, Jadel M; Biavatti, Maique W

    2016-03-01

    The biosynthesis and biotechnological production of Rosmarinic acid, a phenolic ester that is widespread in the plant kingdom, has been widely investigated. This compound has shown many remarkable biological and pharmacological activities, which have led to its pharmaceutical and analytical development, as well as clinical studies, which are summarized and analyzed here for the first time. This review compiles data from the Pubmed, Scopus, Scifinder, Web Of Science, and Science Direct databases published between 1990 and 2015, restricting the search to works with the keywords "Rosmarinic acid" in the title. The initial search identified more than 800 articles; after an initial screening and removal of duplicate works, the search was further refined, resulting in approximately 300 articles that were scrutinized and comprise this review. The articles were organized to describe extraction and isolation, analytical methods, pharmaceutical development, and biological and pharmacological activities [divided into nonclinical (in vitro, in vivo) and clinical studies], pharmacokinetic studies, and stability studies.

  15. Globalization, pharmaceutical pricing, and South African health policy: managing confrontation with U.S. firms and politicians.

    PubMed

    Bond, P

    1999-01-01

    Brewing since the advent of South African democracy in 1994 and promises of health sector transformation, an extraordinary drug war between President Nelson Mandela's African National Congress government and U.S. pharmaceutical manufacturers took on global proportions in 1998-1999. Within months of the passage of South African legislation aimed at lowering drug prices, the U.S. government quickly applied powerful pressure points to repeal a clause allowing potential importation of generic substitutes and imposition of compulsory licensing. At stake were not only local interpretations of patent law and World Trade Organization rules on Trade in Intellectual Property, but international power relations between developing countries and the pharmaceutical industry. In reviewing the ongoing debate, this article considers post-apartheid public health policy, U.S. government pressure to change the law, and pharmaceutical industry interests and links to the U.S. government, and evaluates various kinds of resistance to U.S. corporate and government behavior. The case thus raises--not for the first time--concerns about contemporary imperialism ("globalization"), the role of the profit motive as an incentive in vital pharmaceutical products, and indeed the depth of "democracy" in a country where high-bidding international drug firms have sufficient clout to embarrass Vice President Al Gore by pitting him against the life-and-death interests of millions of consumers of essential drugs in South Africa and other developing countries.

  16. Bioceramics and pharmaceuticals: A remarkable synergy

    NASA Astrophysics Data System (ADS)

    Vallet-Regí, María; Balas, Francisco; Colilla, Montserrat; Manzano, Miguel

    2007-09-01

    The research on controlled drug delivery systems using bioceramics as host matrices presents two distinct sides; one route aims at embedding pharmaceuticals in biomaterials designed for the reconstruction or regeneration of living tissues, in order to counteract inflammatory responses, infections, bone carcinomas and so forth, while the other route deals with the more traditional drug introduction systems, i.e. oral administration. The incorporation of pharmaceuticals to bioceramic matrices could be very interesting in clinical practice. It is rather common in these days for an orthopedic surgeon working in bone reconstruction to use bioceramics. An added value to the production of these ceramics would be the optional addition of pharmaceuticals such as antibiotics, anti-inflammatories, anti-carcinogens, etc. In this sense, if we take into account the infections statistics at hip joint prostheses, the incidence varies between 2 and 4%, reaching up to a 45% in bolts used as external fixation. One of the main problems in these situations is the access to the infected area of the bone, in order to deliver the adequate antibiotic. If the pharmaceutical could be included within the implant itself, the added value would be straightforward. And if the bioceramic is bioactive, and therefore precursor of new bone tissue, the capability to introduce peptides, proteins or growth factors at its pores could accelerate the bone regeneration processes. We are facing a fine example of multidisciplinary research, where the so-called transversal supply of knowledge from and between the domains of materials science, biology and medicine will empower the know-how and applications that shall, undoubtedly, give rise to new advances in science and technology.

  17. An overview of the pharmaceutical industry.

    PubMed

    Stave, G M; Joines, R

    1997-01-01

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

  18. The Pharmaceutical Benefits Scheme 2003-2004.

    PubMed

    Harvey, Ken J

    2005-01-12

    The Pharmaceutical Benefits Scheme (PBS) grew by 8% in 2003-04; a slower rate than the 12.0% pa average growth over the last decade. Nevertheless, the sustainability of the Scheme remained an ongoing concern given an aging population and the continued introduction of useful (but increasingly expensive) new medicines. There was also concern that the Australia-United States Free Trade Agreement could place further pressure on the Scheme. In 2003, as in 2002, the government proposed a 27% increase in PBS patient co-payments and safety-net thresholds in order to transfer more of the cost of the PBS from the government to consumers. While this measure was initially blocked by the Senate, the forthcoming election resulted in the Labor Party eventually supporting this policy. Recommendations of the Pharmaceutical Benefits Advisory Committee to list, not list or defer a decision to list a medicine on the PBS were made publicly available for the first time and the full cost of PBS medicines appeared on medicine labels if the price was greater than the co-payment. Pharmaceutical reform in Victorian public hospitals designed to minimise PBS cost-shifting was evaluated and extended to other States and Territories. Programs promoting the quality use of medicines were further developed coordinated by the National Prescribing Service, Australian Divisions of General Practice and the Pharmacy Guild of Australia. The extensive uptake of computerised prescribing software by GPs produced benefits but also problems. The latter included pharmaceutical promotion occurring at the time of prescribing, failure to incorporate key sources of objective therapeutic information in the software and gross variation in the ability of various programs to detect important drug-drug interactions. These issues remain to be tackled.

  19. Cubanes: Super explosives and potential pharmaceutical intermediates

    NASA Technical Reports Server (NTRS)

    Bashir-Hashemi, A.

    1994-01-01

    The cubane molecule, in which eight carbon atoms are locked in a cubic framework, shows great potential for both military and pharmaceutical applications. Octanitrocubane, with a predicted density of 2.1 g/cc and strain energy of more than 165 kcal/mol, is considered to be the 'super-explosive', while cubane derivatives submitted to the National Institutes of Health for preliminary biological activity screening have displayed promising anti-cancer and anti-HIV activity.

  20. Probing the string winding sector

    NASA Astrophysics Data System (ADS)

    Aldazabal, Gerardo; Mayo, Martín; Nuñez, Carmen

    2017-03-01

    We probe a slice of the massive winding sector of bosonic string theory from toroidal compactifications of Double Field Theory (DFT). This string subsector corresponds to states containing one left and one right moving oscillators. We perform a generalized Kaluza Klein compactification of DFT on generic 2 n-dimensional toroidal constant backgrounds and show that, up to third order in fluctuations, the theory coincides with the corresponding effective theory of the bosonic string compactified on n-dimensional toroidal constant backgrounds, obtained from three-point amplitudes. The comparison between both theories is facilitated by noticing that generalized diffeomorphisms in DFT allow to fix generalized harmonic gauge conditions that help in identifying the physical degrees of freedom. These conditions manifest as conformal anomaly cancellation requirements on the string theory side. The explicit expression for the gauge invariant effective action containing the physical massless sector (gravity+antisymmetric+gauge+ scalar fields) coupled to towers of generalized Kaluza Klein massive states (corresponding to compact momentum and winding modes) is found. The action acquires a very compact form when written in terms of fields carrying O( n, n) indices, and is explicitly T-duality invariant. The global algebra associated to the generalized Kaluza Klein compactification is discussed.

  1. Photo-pharmaceutical therapy: features and prospects

    NASA Astrophysics Data System (ADS)

    Zharov, Vladimir P.; Potapenko, Alexander Y.; Minenkov, Alexander A.

    2001-07-01

    This article is an attempt to analyze the concept, distinguishing features and possible application of photo- pharmaceutical therapy (PPT). Besides photopheresis, PUVA, and photodynamic therapy, PPT also embraces a broad spectrum of various combinations of light and drugs. PPT techniques can be classified according to the role of light in drug therapy into several groups: 1) Light activation of drugs before, during or after their administration, 2) light activation of cells of biotissue to potentiate the pharmaceutical effect of drugs, 3) light assisted drug delivery, 4) optical sensing of drug action at cellular and subcellular levels, and 5) selective photochemistry of drugs during their manufacturing. PPT seeks to describe the mechanisms of light-drug interaction, to time and sequence light-drug action, and to verify their synergetic effect. This article yields the results of developing new PPT modifications created in collaboration with some Russian scientific institutes and medical centers. The developed modifications are as follows: 1) drug pre-administration photoactivation, 2) antibody-photoconformation photoimmunotherapy, 3) photophonophoresis with a blend of photosensitizers and antibiotics, 4) photoelectrophoresis, 5) drug effect enhancement due to laser-induced blood circulation activation, 6) photoimmunization with alpha- fetoprotein, 7) photo-pharmaceutical dosimetry, and 8) a rapid drug toxicity photoassay.

  2. Improving environmental risk assessment of human pharmaceuticals.

    PubMed

    Ågerstrand, Marlene; Berg, Cecilia; Björlenius, Berndt; Breitholtz, Magnus; Brunström, Björn; Fick, Jerker; Gunnarsson, Lina; Larsson, D G Joakim; Sumpter, John P; Tysklind, Mats; Rudén, Christina

    2015-05-05

    This paper presents 10 recommendations for improving the European Medicines Agency's guidance for environmental risk assessment of human pharmaceutical products. The recommendations are based on up-to-date, available science in combination with experiences from other chemical frameworks such as the REACH-legislation for industrial chemicals. The recommendations concern: expanding the scope of the current guideline; requirements to assess the risk for development of antibiotic resistance; jointly performed assessments; refinement of the test proposal; mixture toxicity assessments on active pharmaceutical ingredients with similar modes of action; use of all available ecotoxicity studies; mandatory reviews; increased transparency; inclusion of emission data from production; and a risk management option. We believe that implementation of our recommendations would strengthen the protection of the environment and be beneficial to society. Legislation and guidance documents need to be updated at regular intervals in order to incorporate new knowledge from the scientific community. This is particularly important for regulatory documents concerning pharmaceuticals in the environment since this is a research field that has been growing substantially in the last decades.

  3. Pharmaceutical policy reform in the Russian Federation.

    PubMed

    Rudisill, Caroline; Vandoros, Sotiris; Antoun, Joseph George

    2014-06-01

    Of Russia's 142 million citizens, fewer than 20 million are enrolled in outpatient drug coverage plans. The current government aims to establish universal health insurance including outpatient medicines. Based on the current political and regulatory environment, this report explores pharmaceutical pricing options for Russia that balance greater access to medicines with achieving government plans of boosting local pharmaceutical production. To match innovative medicine prices with their health benefits, in the long run, we suggest that Russia consider adopting value-based pricing, and in the short term, that it introduce direct price negotiations and price drugs according to reference countries that use health technology assessment. Although generic market shares are high, generic medicine prices are higher than they should be. We propose tenders at the manufacturer level for the pricing of high-selling generics, and free pricing for products with sufficient market competition. These policy recommendations are a jumping-off point for further discussion about how pharmaceutical policy could aid this major economy to achieve its population health and health service goals.

  4. New Medium for Pharmaceutical Grade Arthrospira

    PubMed Central

    Amara, Amro A.; Steinbüchel, Alexander

    2013-01-01

    The aim of this study is to produce a pharmaceutical grade single cell product of Arthrospira from a mixed culture. We have designed a medium derived from a combination between George's and Zarrouk's media. Our new medium has the ability to inhibit different forms of cyanobacterium and microalgae except the Chlorella. The medium and the cultivation conditions have been investigated to map the points where only Arthrospira could survive. For that, a mixed culture of pure Chlorella and Arthrospira (~90 : 10) has been used to develop the best medium composition that can lead to the enrichment of the Arthrospira growth and the inhibition of the Chlorella growth. To enable better control and to study its growth, an 80 l photobioreactor has been used. We have used high saline (2xA-St) medium which has been followed by in fermentor reducing its concentration to 1.5x. The investigation proves that Chlorella has completely disappeared. A method and a new saline medium have been established using a photobioreactor for in fermentor production of single cell Arthrospira. Such method enables the production of pure pharmaceutical grade Arthrospira for medicinal and pharmaceutical applications or as a single cell protein. PMID:26904724

  5. Defining Patient Centric Pharmaceutical Drug Product Design.

    PubMed

    Stegemann, Sven; Ternik, Robert L; Onder, Graziano; Khan, Mansoor A; van Riet-Nales, Diana A

    2016-09-01

    The term "patient centered," "patient centric," or "patient centricity" is increasingly used in the scientific literature in a wide variety of contexts. Generally, patient centric medicines are recognized as an essential contributor to healthy aging and the overall patient's quality of life and life expectancy. Besides the selection of the appropriate type of drug substance and strength for a particular indication in a particular patient, due attention must be paid that the pharmaceutical drug product design is also adequately addressing the particular patient's needs, i.e., assuring adequate patient adherence and the anticipate drug safety and effectiveness. Relevant pharmaceutical design aspects may e.g., involve the selection of the route of administration, the tablet size and shape, the ease of opening the package, the ability to read the user instruction, or the ability to follow the recommended (in-use) storage conditions. Currently, a harmonized definition on patient centric drug development/design has not yet been established. To stimulate scientific research and discussions and the consistent interpretation of test results, it is essential that such a definition is established. We have developed a first draft definition through various rounds of discussions within an interdisciplinary AAPS focus group of experts. This publication summarizes the outcomes and is intended to stimulate further discussions with all stakeholders towards a common definition of patient centric pharmaceutical drug product design that is useable across all disciplines involved.

  6. Cross-Sector Review of Drivers and Available 3Rs Approaches for Acute Systemic Toxicity Testing

    PubMed Central

    Seidle, Troy; Robinson, Sally; Holmes, Tom; Creton, Stuart; Prieto, Pilar; Scheel, Julia; Chlebus, Magda

    2010-01-01

    Acute systemic toxicity studies are carried out in many sectors in which synthetic chemicals are manufactured or used and are among the most criticized of all toxicology tests on both scientific and ethical grounds. A review of the drivers for acute toxicity testing within the pharmaceutical industry led to a paradigm shift whereby in vivo acute toxicity data are no longer routinely required in advance of human clinical trials. Based on this experience, the following review was undertaken to identify (1) regulatory and scientific drivers for acute toxicity testing in other industrial sectors, (2) activities aimed at replacing, reducing, or refining the use of animals, and (3) recommendations for future work in this area. PMID:20484382

  7. Responsible leader behavior in health sectors.

    PubMed

    Longest, Beaufort

    2017-02-06

    Purpose The purpose of this paper is to expand attention to responsible leader behavior in the world's health sectors by explaining how this concept applies to health sectors, considering why health sector leaders should behave responsibly, reviewing how they can do so, and asserting potential impact through an applied example. Design/methodology/approach This paper is a viewpoint, reflecting conceptualizations rooted in leadership literature which are then specifically applied to health sectors. A definition of responsible leader behavior is affirmed and applied specifically in health sectors. Conceptualizations and viewpoints about practice of responsible leader behavior in health sectors and potential consequences are then discussed and asserted. Findings Leadership failures and debacles found in health, but more so in other sectors, have led leadership researchers to offer insights, many of them empirical, into the challenges of leadership especially by more clearly delineating responsible leader behavior. Practical implications Much of what has been learned in the research about responsible leader behavior offers pathways for health sector leaders to more fully practice responsible leadership. Social implications This paper asserts and provides a supporting example that greater levels of responsible leader behavior in health sectors hold potentially important societal benefits. Originality/value This paper is the first to apply emerging conceptualizations and early empirical findings about responsible leader behavior specifically to leaders in health sectors.

  8. [Essential medicines and the selection process in management practices of pharmaceutical services in Brazilian states and municipalities].

    PubMed

    Magarinos-Torres, Rachel; Pepe, Vera Lucia Edais; Oliveira, Maria Auxiliadora; Osorio-de-Castro, Claudia Garcia Serpa

    2014-09-01

    The selection of medicines is a skilled process that produces an essential medicines list (EML) and substantiates rational management of pharmaceutical services. This paper presents the selection of essential medicines in Brazilian states and municipalities. It discusses the perception of pharmaceutical services managers regarding the concept of essential medicines and strategies adopted for their implementation, in addition to investigating how the National Essential Medicines List was adopted and is supporting local pharmaceutical services actions. A nationwide study was carried out adopting a qualitative methodological approach in health. State and municipal managers from the five Brazilian regions were interviewed. The findings point to weaknesses in local selection procedures and in the use of the National Essential Medicines List (Rename). Barriers such as lack of formalization of pharmaceutical services at regional levels, difficulties in drafting and maintaining a pharmacy and therapeutics committee and the acritical incorporation of drugs on the EML were identified. States and municipalities have distortions that exclude the EML form the concept of essential medicines.

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

    PubMed Central

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

    2013-01-01

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

  10. Novel methodology for pharmaceutical expenditure forecast

    PubMed Central

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

    2014-01-01

    Background and objective The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the ‘EU Pharmaceutical expenditure forecast’; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Methods 1) Identification of all pharmaceuticals going off-patent and new branded medicinal products over a 5-year forecasting period in seven European Union (EU) Member States. 2) Development of a model to estimate direct and indirect impacts (based on health policies and clinical experts) on savings of generics and biosimilars. Inputs were originator sales value, patent expiry date, time to launch after marketing authorization, price discount, penetration rate, time to peak sales, and impact on brand price. 3) Development of a model for new drugs, which estimated sales progression in a competitive environment. Clinical expected benefits as well as commercial potential were assessed for each product by clinical experts. Inputs were development phase, marketing authorization dates, orphan condition, market size, and competitors. 4) Separate analysis of the budget impact of products going off-patent and new drugs according to several perspectives, distribution chains, and outcomes. 5) Addressing uncertainty surrounding estimations via deterministic and probabilistic sensitivity analysis. Results This methodology has proven to be effective by 1) identifying the main parameters impacting the variations in pharmaceutical expenditure forecasting across countries: generics discounts and penetration, brand price after patent loss, reimbursement rate, the penetration of biosimilars and

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

    PubMed

    Sihn, Kyu-Hwan

    2015-12-01

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

  12. [Opportunities in the pharmaceutical industry and the local development logic based on the Brazilian biomes: the basis for a national policy discussion].

    PubMed

    Villas Bôas, Glauco de Kruse; Gadelha, Carlos Augusto Grabois

    2007-06-01

    This study discusses new concepts in the technological development of plant-derived medicines and their relevance to public health, highlighting opportunities in the pharmaceutical market both for the production of herbal medicines and the development of new drugs based on plant substrates and molecules. Recent theoretical and scientific premises for the socioeconomic development of the "Knowledge Age" (considering local production arrangements and systems) could guarantee a competitive advantage for the sector, given the exuberant flora and biodiversity in the various Brazilian biomes.

  13. [History of pharmaceutical packaging in modern Japan. II--Package size of pharmaceuticals].

    PubMed

    Hattori, Akira

    2014-01-01

    When planning pharmaceutical packaging, the package size for the product is important for determining the basic package concept. Initially, the sales unit for herbal medicines was the weight; however in 1868, around the early part of the Meiji era, Japanese and Western units were being used and the sales unit was confusing. Since the Edo era, the packing size for OTC medicines was adopted using weight, numbers, dosage or treatment period. These were devised in various ways in consideration of convenience for the consumer, but the concept was not simple. In 1887, from the time that the first edition of the Japanese Pharmacopoeia came out, use of the metric system began to spread in Japan. Its use spread gradually for use in the package size of pharmaceutical products. At the time, the number of pharmaceutical units (i.e., tablets), became the sales unit, which is easy to understand by the purchaser.

  14. Life cycle analysis within pharmaceutical process optimization and intensification: case study of active pharmaceutical ingredient production.

    PubMed

    Ott, Denise; Kralisch, Dana; Denčić, Ivana; Hessel, Volker; Laribi, Yosra; Perrichon, Philippe D; Berguerand, Charline; Kiwi-Minsker, Lioubov; Loeb, Patrick

    2014-12-01

    As the demand for new drugs is rising, the pharmaceutical industry faces the quest of shortening development time, and thus, reducing the time to market. Environmental aspects typically still play a minor role within the early phase of process development. Nevertheless, it is highly promising to rethink, redesign, and optimize process strategies as early as possible in active pharmaceutical ingredient (API) process development, rather than later at the stage of already established processes. The study presented herein deals with a holistic life-cycle-based process optimization and intensification of a pharmaceutical production process targeting a low-volume, high-value API. Striving for process intensification by transfer from batch to continuous processing, as well as an alternative catalytic system, different process options are evaluated with regard to their environmental impact to identify bottlenecks and improvement potentials for further process development activities.

  15. Pharmaceutical applications of confocal laser scanning microscopy: the physical characterisation of pharmaceutical systems.

    PubMed

    Pygall, Samuel R; Whetstone, Joanne; Timmins, Peter; Melia, Colin D

    2007-12-10

    The application of confocal laser scanning microscopy (CLSM) to the physicochemical characterisation of pharmaceutical systems is not as widespread as its application within the field of cell biology. However, methods have been developed to exploit the imaging capabilities of CLSM to study a wide range of pharmaceutical systems, including phase-separated polymers, colloidal systems, microspheres, pellets, tablets, film coatings, hydrophilic matrices, and chromatographic stationary phases. Additionally, methods to measure diffusion in gels, bioadhesives, and for monitoring microenvironmental pH change within dosage forms have been utilised. CLSM has also been used in the study of the physical interaction of dosage forms with biological barriers such as the eye, skin and intestinal epithelia, and in particular, to determine the effectiveness of a plethora of pharmaceutical systems to deliver drugs through these barriers. In the future, there is continuing scope for wider exploitation of existing techniques, and continuing advancements in instrumentation.

  16. Human pharmaceutical products in the environment - the "problem" in perspective.

    PubMed

    Taylor, David; Senac, Thomas

    2014-11-01

    Concerns about the potential for significant environmental impact from residues of human pharmaceuticals emerged at the beginning of the 21st century. Since then there has been an exponential rise in the number of publications and conferences on this "problem". However, this intense focus on human pharmaceuticals is misplaced. Pharmaceuticals do not consist of a coherent group of substances with similar chemical, structural, biological or toxicological properties. Pharmaceuticals are only identifiable from their use: in other words substances can be divided into two classes, those that are used as pharmaceuticals and those for which a possible pharmaceutical use has not yet been discovered. For example, nitro-glycerine, Warfarin and dimethyl fumarate, initially sold respectively as an explosive, a rodenticide and a mould inhibitor have subsequently all been used as pharmaceuticals. As analytical science advances, an increasing range of environmental contaminants, including pharmaceuticals, is being identified at sub μgL(-1) concentrations. Although, human and environmental exposure to these contaminants will be low, all of them need to be subjected to risk assessment on a case by case basis. Many of these substances, including human pharmaceuticals, may have little, if any, impact on human health or the environment, however for some substances there may be a significant risk and in these cases appropriate action should be taken. However considering all human pharmaceuticals as a special case, isolated from the wider range of emerging contaminants, is scientifically unjustifiable and diverts resources away from the consideration of other substances that may be of considerably more significance.

  17. First report on interspecies quantitative correlation of ecotoxicity of pharmaceuticals.

    PubMed

    Kar, Supratik; Roy, Kunal

    2010-10-01

    Pharmaceuticals being extensively and progressively used in human and veterinary medicine are emerging as significant environmental contaminants. Pharmaceuticals are designed to have a specific mode of action and many of them are persistent in the body. These features among others make pharmaceuticals to be evaluated for potential effects on aquatic flora and fauna. Low levels of pharmaceuticals have been detected in many countries in sewage treatment plant effluents, surface waters, groundwater and drinking waters. In contrast, there is a general scarcity of publicly available ecotoxicological data concerning pharmaceuticals. Interspecies toxicity correlations provide a tool for estimating contaminant sensitivity with known levels of uncertainty for a diversity of wildlife species. In this context, we have developed interspecies toxicity correlation between Daphnia magna (zooplankton) and fish (species according to OECD guidelines) assessing the ecotoxicological hazard potential of diverse 77 pharmaceuticals. The developed models are validated and consensus models are presented to predict toxicity of the individual compounds for any one species when the data for the other species are available. Informative illustrations of the contributing structural fragments which are responsible for the greater toxicity of the diverse pharmaceuticals are identified by the developed models. Developed models are also used to predict fish toxicities of 59 pharmaceuticals (for which Daphnia toxicities are present) and Daphnia toxicities of 30 pharmaceuticals (for which fish toxicities are present). This study will allow a better and comprehensive risk assessment of pharmaceuticals for which toxicity data is missing for a particular endpoint.

  18. Why lunch matters: assessing physicians' perceptions about industry relationships.

    PubMed

    Fugh-Berman, Adriane J; Scialli, Anthony R; Bell, Alicia M

    2010-01-01

    Many studies have shown that pharmaceutical marketing affects prescribing choices. Studies that have assessed the effects of educational interventions on perceptions of pharmaceutical promotion have found mixed results. This study assesses the short-term effects of an educational intervention about marketing tactics on the attitudes and fund of knowledge of residents, medical students, and attending physicians. A 1-hour slide show that covered detailing, prescription tracking, drug samples, medical meetings, and journals was developed by PharmedOut and presented at a total of 14 grand rounds and seminars at departments of family medicine, internal medicine, pediatrics, psychiatry, cardiology, and neurology. Pre- and posttests included attitudinal and fact questions addressing the influence of drug reps, gifts, pharmaceutical advertising and drug samples on prescribing behavior. The posttest asked whether attendees intended to change their prescribing behavior. The Mann-Whitney U test was used for Likert-scale questions and the Fisher exact test was used to compare the number of pre- and posttest correct answers for the multiple choice and true/false questions. Three hundred seventy-three participants completed pre- and posttests. Significant attitudinal shifts were seen overall, particularly in questions addressing influence of salespeople on physicians in general and on the respondent individually. Some participants commented that they intended to stop seeing drug reps or stop attending industry-funded meals. A new educational presentation can substantially shift attitudes toward perceived susceptibility to pharmaceutical marketing activities. Further research is needed to see if attitude change persists.

  19. Ecological risk assessment of pharmaceuticals in the receiving environment of pharmaceutical wastewater in Pakistan.

    PubMed

    Ashfaq, Muhammad; Nawaz Khan, Khujasta; Saif Ur Rehman, Muhammad; Mustafa, Ghulam; Faizan Nazar, Muhammad; Sun, Qian; Iqbal, Javed; Mulla, Sikandar I; Yu, Chang-Ping

    2017-02-01

    The pharmaceutical industry of Pakistan is growing with an annual growth rate of 10%. Besides this growth, this industry is not complying with environmental standards, and discharging its effluent into domestic wastewater network. Only limited information is available about the occurrence of pharmaceutical compounds (PCs) in the environmental matrices of Pakistan that has motivated us to aim at the occurrence and ecological risk assessment of 11 PCs of different therapeutic classes in the wastewater of pharmaceutical industry and in its receiving environmental matrices such as sludge, solid waste and soil samples near the pharmaceutical formulation units along Shiekhupura road, Lahore, Pakistan. Target PCs (paracetamol, naproxen, diclofenac, ibuprofen, amlodipine, rosuvastatin, ofloxacin, ciprofloxacin, moxifloxacin, sparfloxacin and gemifloxacin) were quantified using in-house developed HPLC-UV. Ibuprofen (1673µg/L, 6046µg/kg, 1229µg/kg and 610µg/kg), diclofenac (836µg/L, 4968µg/kg, 6632µg/kg and 257µg/kg) and naproxen (464µg/L, 7273µg/kg, 4819µg/kg and 199µg/kg) showed the highest concentrations among 11 target PCs in wastewater, sludge, solid waste and soil samples, respectively. Ecological risk assessment, in terms of risk quotient (RQ), was also carried out based on the maximum measured concentration of PCs in wastewater. The maximum RQ values obtained were with paracetamol (64 against daphnia), naproxen (177 against fish), diclofenac (12,600 against Oncorhynchus mykiss), ibuprofen (167,300 against Oryzias latipes), ofloxacin (81,000 against Pseudomonas putida) and ciprofloxacin (440 against Microcystis aeruginosa). These results show a high level of ecological risk due to the discharge of untreated wastewater from pharmaceutical units. This risk may further lead to food web contamination and drug resistance in pathogens. Thus, further studies are needed to detect the PCs in crops as well as the government should strictly enforce environmental

  20. Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials.

    PubMed

    Fisher, Jill A

    2015-03-01

    Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating in the studies. For research staff, there are three mechanisms by which risk becomes banal: a perceived homogeneity of studies, Fordist work regimes, and data-centric discourse. For healthy volunteers, repeat study participation contributes to the institutional banalization of risk both through the process of desensitization to risk and the formation of trust in the clinics. I argue that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research.

  1. Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials

    PubMed Central

    Fisher, Jill A.

    2015-01-01

    Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating in the studies. For research staff, there are three mechanisms by which risk becomes banal: a perceived homogeneity of studies, Fordist work regimes, and data-centric discourse. For healthy volunteers, repeat study participation contributes to the institutional banalization of risk both through the process of desensitization to risk and the formation of trust in the clinics. I argue that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research. PMID:25914430

  2. Research Frontiers in Public Sector Performance Measurement

    NASA Astrophysics Data System (ADS)

    Zhonghua, Cai; Ye, Wang

    In "New Public Management" era, performance measurement has been widely used in managerial practices of public sectors. From the content and features of performance measurement, this paper aims to explore inspirations on Chinese public sector performance measurement, which based on a review of prior literatures including influencial factors, methods and indicators of public sector performance evaluation. In the end, arguments are presented in this paper pointed out the direction of future researches in this field.

  3. Security Force Assistance and Security Sector Reform

    DTIC Science & Technology

    2013-09-01

    development, and planning, 63 Shultz: Security Force Assistance and Security Sector Reform budgeting and management are critical in reforming a defense...and Security Sector Reform Richard H. Shultz, Jr. JSOU Report 13-5 September 2013 Joint Special Operations University 7701 Tampa Point Boulevard...Assistance and Security Sector Reform 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK

  4. Healthcare and Social Assistance Sector (NAICS 62)

    EPA Pesticide Factsheets

    Environmental regulations and information for the Healthcare sector, including doctor's offices, hospitals, and medical laboratories. Includes information about dental amalgam wastewater, sterilizers, and medical waste.

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

    PubMed

    Edwards, Brian; Chakraborty, Sweta

    2012-11-01

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

  6. The institutionalization of pharmaceutical administration after the korean liberation: focusing on regulating the pharmaceutical affairs law(yaksabeop) in 1953.

    PubMed

    Sihn, Kyu-Hwan

    2013-12-01

    The pharmaceutical administration under U.S Military Government in Korea and government of the Republic of Korea aimed at cleaning up the vestiges of Japanese imperialism which the pharmaceutical administration attached police administration and preparing with legal and systemic basis after the Korean liberation. The pharmaceutical bureau under U.S Military Government in Korea was reorganized as the independent division. The pharmaceutical bureau focused on preserving order, narcotics control and the distribution of relief drug. U.S Military Government proceeded supply side pharmaceutical policy for the distribution of relief drug without constructing human and material infrastructure. After the Korean War, Korean society asked the construction of system for nation building. Korean national assembly regulated National Medical Law(Gukmin uiryobeop) for promotion of public health in 1951. The Pharmaceutical Affairs Law(Yaksabeop) was regulated in 1953, and it prescribed the job requirement of pharmacist, apothecary, and drug maker and seller, and presented the frame of managing medical supplies. The Pharmaceutical Law originally planned the ideal pharmaceutical administration, but it rather secured the status of traditional apothecary, and drug maker and seller. On the contrary, though the Pharmaceutical Law guaranteed the traditional druggists, it did not materialize reproduction system such as educational and license system. It means that the traditional druggists would be degenerated in the near future. After the armistice agreement in 1953, Korean was in medical difficulties. Korean government was suffered from the deficiency of medical resources. Because of destruction of pharmaceutical facilities, Korean had to depend on United States and international aid. The Pharmaceutical Affairs Law did not cleaned up the vestiges of Japanese imperialism, and compromised with reality lacked human and material infrastructure. As a result, the law became the origin of

  7. Patients Perception of Community Pharmacist in Bosnia and Herzegovina

    PubMed Central

    Catic, Tarik; Jusufovic, Fatima Insanic; Tabakovic, Vedad

    2013-01-01

    Community pharmacists play a significant role in patient/disease management and perception by patients is increasingly important. A self-administered questionnaire was developed consisted of sociodemographic part and 15 questions. Patients have a positive overall perception of community pharmacists that is comparable to most studies in Europe. Community pharmacists’ beyond dispensing drugs play a significant role in patient and disease management. This role of the pharmacist is performed through pharmaceutical care. Patient’s opinion is increasingly considered to be a useful component in the determination of care outcomes and consumer satisfaction is an integral component of the quality of primary health care. For the purpose of this study we developed self-administered questionnaire consisted of sociodemographic part, and 15 questions. Survey has been conducted in 10 pharmacies. Results are presented in tables and figures and descriptive statistics has been used. We found that patients in Bosnia and Herzegovina have a positive overall perception of community pharmacists and of the services offered from community pharmacies that is comparable to most studies in Europe, but there is still room for improvement of relationships and pharmaceutical services. PMID:24167438

  8. Embodied Perception: A Proposal to Reconcile Affordance and Spatial Perception

    PubMed Central

    2015-01-01

    Proffitt's embodied approach to perception is deeply indebted to Gibson's ecological approach to visual perception, in particular the idea that the primary objects of perception are affordances or what the environment offers for action. Yet, rather than directly addressing affordance perception, most of the empirical work evaluating Proffitt's approach focuses on the perception of spatial properties of the environment. We propose that theoretical and empirical efforts should be directed toward an understanding of the relationship between affordance perception and spatial perception, keeping in mind that this relationship is nontrivial because affordance perception is dichotomous, whereas the perception of spatial properties is gradual. We argue that the perception of spatial properties of the environment is enslaved by affordance perception, most notably at the critical boundaries for action. To empirically scrutinize this proposition, and to solve issues raised regarding the validity of several empirical findings, we call for joint research efforts to further understanding of embodied perception.

  9. Artificial perception and consciousness

    NASA Astrophysics Data System (ADS)

    Caulfield, H. John; Johnson, John L.

    2000-06-01

    Perception has both unconscious and conscious aspects. In all cases, however, what we perceive is a model of reality. By brain construction through evolution, we divide the world into two parts--our body and the outside world. But the process is the same in both cases. We perceive a construct usually governed by sensed data but always involving memory, goals, fears, expectations, etc. As a first step toward Artificial Perception in man-made systems, we examine perception in general here.

  10. Psychobiology and Food Perception

    NASA Technical Reports Server (NTRS)

    Neilson, A.

    1985-01-01

    Psychobiology is a scientific discipline which encompasses the phenomena known to be important as regards nutrition and food consumption in space. Specifically, it includes those areas of biology which are clearly related to behavior, human subjective experience and problems of coping and adapting to stress. Taste and odor perception; perception (knowledge gaps); perception (needs); food preference and menu selection; and choosing of acceptable diets are discussed.

  11. Vendor qualification for pharmaceutical excipients--GMP requirements and approach.

    PubMed

    Patel, K T; Chotal, N P

    2010-11-01

    Excipients are, in the large majority of cases, not made specifically for pharmaceutical use. Most pharmaceutical excipient manufacturers supply less than 10% of the total production of that particular material for pharmaceutical use. Excipient product portfolio consists of hundreds of products differing in chemistry, origin and functionality and they are used in many different applications. The days of treating excipients like commodities and buying them without fully qualifying the source and the entire distribution chain have gone by as GMP regulations demands to ensure quality of other materials used in the manufacturing process. The paradigm that exists in some pharmaceutical companies today where excipients are sourced from distributors without knowing the actual manufacturer, manufacturing site and full distribution lifecycle chain to be changed. The present contribution gives an overview about the current moves on GMP requirements for pharmaceutical excipient and approach for qualification of pharmaceutical excipient manufacturers.

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

    PubMed

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

    2016-01-18

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

  13. Invisible pollution: the impact of pharmaceuticals in the water supply.

    PubMed

    Strauch, Kimberly A

    2011-12-01

    During the past decade, interest in the public and environmental health effects of trace levels of pharmaceuticals and personal care products in the water supply has evolved. Although most pharmaceuticals are tested for human safety and efficacy prior to marketing and distribution, the potential for adverse effects in nontarget populations exposed to minute environmental medication doses has not been established. Several recent studies have demonstrated adverse effects from longstanding, low-dose exposures in both aquatic and terrestrial wildlife, although human toxicity related to trace levels of pharmaceuticals in the water supply remains unknown. This article provides a brief overview of the routes through which pharmaceuticals are introduced into the environment; a description of the effects of longstanding, low-dose exposures in aquatic and terrestrial animals, including human health effects; an update on the current regulations and solutions regarding pharmaceutical disposal practices; and a discussion of implications for reducing pharmaceuticals in the environment for occupational health nurses and other allied health professionals.

  14. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2012-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Development of monographs for The International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products--points to consider; Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients.

  15. Public perceptions and information gaps in solar energy in Texas

    NASA Astrophysics Data System (ADS)

    Rai, Varun; Beck, Ariane L.

    2015-07-01

    Studying the behavioral aspects of the individual decision-making process is important in identifying and addressing barriers in the adoption of residential solar photovoltaic (PV). However, there is little systematic research focusing on these aspects of residential PV in Texas, an important, large, populous state, with a range of challenges in the electricity sector including increasing demand, shrinking reserve margins, constrained water supply, and challenging emissions reduction targets under proposed federal regulations. This paper aims to address this gap through an empirical investigation of a new survey-based dataset collected in Texas on solar energy perceptions and behavior. The results of this analysis offer insights into the perceptions and motivations influencing intentions and behavior toward solar energy in a relatively untapped market and help identify information gaps that could be targeted to alleviate key barriers to adopting solar, thereby enabling significant emissions reductions in the residential sector in Texas.

  16. Spectrofluorimetric determination of fluoroquinolones in pharmaceutical preparations

    NASA Astrophysics Data System (ADS)

    Ulu, Sevgi Tatar

    2009-02-01

    Simple, rapid and highly sensitive spectrofluorimetric method is presented for the determination of four fluoroquinolone (FQ) drugs, ciprofloxacin, enoxacin, norfloxacin and moxifloxacin in pharmaceutical preparations. Proposed method is based on the derivatization of FQ with 4-chloro-7-nitrobenzofurazan (NBD-Cl) in borate buffer of pH 9.0 to yield a yellow product. The optimum experimental conditions have been studied carefully. Beer's law is obeyed over the concentration range of 23.5-500 ng mL -1 for ciprofloxacin, 28.5-700 ng mL -1 for enoxacin, 29.5-800 ng mL -1 for norfloxacin and 33.5-1000 ng mL -1 for moxifloxacin using NBD-Cl reagent, respectively. The detection limits were found to be 7.0 ng mL -1 for ciprofloxacin, 8.5 ng mL -1 for enoxacin, 9.2 ng mL -1 for norfloxacin and 9.98 ng mL -1 for moxifloxacin, respectively. Intra-day and inter-day relative standard deviation and relative mean error values at three different concentrations were determined. The low relative standard deviation values indicate good precision and high recovery values indicate accuracy of the proposed methods. The method is highly sensitive and specific. The results obtained are in good agreement with those obtained by the official and reference method. The results presented in this report show that the applied spectrofluorimetric method is acceptable for the determination of the four FQ in the pharmaceutical preparations. Common excipients used as additives in pharmaceutical preparations do not interfere with the proposed method.

  17. Identification of gliadin presence in pharmaceutical products.

    PubMed

    Miletic, I D; Miletic, V D; Sattely-Miller, E A; Schiffman, S S

    1994-07-01

    Celiac disease is characterized by hypersensitivity to the alcohol-soluble wheat proteins called gliadins. Total avoidance of gliadin is the lifelong treatment for such patients. However, wheat gliadins are often present as impurities in industrial starch commonly used in the preparation of different pharmaceutical products. Therefore, some drugs might contain gliadin, which can be dangerous for sensitive patients if taken in large amounts or used permanently. The purpose of this study was to develop a sensitive, reliable assay that is specific for the detection of gliadins in pharmaceutical products. Gliadins were extracted here using sodium dodecyl sulfate rather than 70% ethyl alcohol, which has been the traditional solvent. This gliadin extract was utilized in a dot-blot assay that incorporated an antigliadin antibody developed in rabbit and labeled with peroxidase. 4-Chloro-1-naphthol was used as a peroxidase-specific substrate. Isolated wheat gliadin was used as the positive control. Dilution experiments showed that the lower level of sensitivity for the assay was in the range of 0.0045 mg/ml of gliadin, which is a concentration level lower than that suggested for a gluten-free diet. The assay developed here revealed that 71.2% of 59 prescription and nonprescription drugs tested contained gliadin in the amount detected by our dot-blot assay. The prescription drugs tested were among the top 50 most frequently dispensed in U.S. community pharmacies. The nonprescription drugs were among those that constitute the largest sales in the United States. The results showed that the simple dot-blot assay developed here can be used for pharmaceutical testing performed either by hospital laboratories or by patients themselves.

  18. Academic psychiatry and the pharmaceutical industry.

    PubMed

    Ban, Thomas A

    2006-05-01

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

  19. Spectrofluorimetric determination of fluoroquinolones in pharmaceutical preparations.

    PubMed

    Ulu, Sevgi Tatar

    2009-02-01

    Simple, rapid and highly sensitive spectrofluorimetric method is presented for the determination of four fluoroquinolone (FQ) drugs, ciprofloxacin, enoxacin, norfloxacin and moxifloxacin in pharmaceutical preparations. Proposed method is based on the derivatization of FQ with 4-chloro-7-nitrobenzofurazan (NBD-Cl) in borate buffer of pH 9.0 to yield a yellow product. The optimum experimental conditions have been studied carefully. Beer's law is obeyed over the concentration range of 23.5-500 ng mL(-1) for ciprofloxacin, 28.5-700 ng mL(-1) for enoxacin, 29.5-800 ng mL(-1) for norfloxacin and 33.5-1000 ng mL(-1) for moxifloxacin using NBD-Cl reagent, respectively. The detection limits were found to be 7.0 ng mL(-1) for ciprofloxacin, 8.5 ng mL(-1) for enoxacin, 9.2 ng mL(-1) for norfloxacin and 9.98 ng mL(-1) for moxifloxacin, respectively. Intra-day and inter-day relative standard deviation and relative mean error values at three different concentrations were determined. The low relative standard deviation values indicate good precision and high recovery values indicate accuracy of the proposed methods. The method is highly sensitive and specific. The results obtained are in good agreement with those obtained by the official and reference method. The results presented in this report show that the applied spectrofluorimetric method is acceptable for the determination of the four FQ in the pharmaceutical preparations. Common excipients used as additives in pharmaceutical preparations do not interfere with the proposed method.

  20. Medications at School: Disposing of Pharmaceutical Waste

    ERIC Educational Resources Information Center

    Taras, Howard; Haste, Nina M.; Berry, Angela T.; Tran, Jennifer; Singh, Renu F.

    2014-01-01

    Background: This project quantified and categorized medications left unclaimed by students at the end of the school year. It determined the feasibility of a model medication disposal program and assessed school nurses' perceptions of environmentally responsible medication disposal. Methods: At a large urban school district all unclaimed…

  1. Laser irradiation to produce amorphous pharmaceuticals.

    PubMed

    Titapiwatanakun, Varin; Tankul, Junlathip; Basit, Abdul W; Gaisford, Simon

    2016-11-30

    Using a high-power CO2 laser to irradiate powder beds, it was possible to induce phase transformation to the amorphous state. Irradiation of a model drug, indometacin, resulted in formation of a glass. Varying the settings of the laser (power and raster speed) was shown to change the physicochemical properties of the glasses produced and all irradiated glasses were found to be more stable than a reference glass produced by melt-quenching. Irradiation of a powder blend of paracetamol and polyvinylpyrrolidone K30 was found to produce a solid amorphous dispersion. The results suggest that laser-irradiation might be a useful method for making amorphous pharmaceuticals.

  2. In silico toxicology for the pharmaceutical sciences

    SciTech Connect

    Valerio, Luis G.

    2009-12-15

    The applied use of in silico technologies (a.k.a. computational toxicology, in silico toxicology, computer-assisted tox, e-tox, i-drug discovery, predictive ADME, etc.) for predicting preclinical toxicological endpoints, clinical adverse effects, and metabolism of pharmaceutical substances has become of high interest to the scientific community and the public. The increased accessibility of these technologies for scientists and recent regulations permitting their use for chemical risk assessment supports this notion. The scientific community is interested in the appropriate use of such technologies as a tool to enhance product development and safety of pharmaceuticals and other xenobiotics, while ensuring the reliability and accuracy of in silico approaches for the toxicological and pharmacological sciences. For pharmaceutical substances, this means active and impurity chemicals in the drug product may be screened using specialized software and databases designed to cover these substances through a chemical structure-based screening process and algorithm specific to a given software program. A major goal for use of these software programs is to enable industry scientists not only to enhance the discovery process but also to ensure the judicious use of in silico tools to support risk assessments of drug-induced toxicities and in safety evaluations. However, a great amount of applied research is still needed, and there are many limitations with these approaches which are described in this review. Currently, there is a wide range of endpoints available from predictive quantitative structure-activity relationship models driven by many different computational software programs and data sources, and this is only expected to grow. For example, there are models based on non-proprietary and/or proprietary information specific to assessing potential rodent carcinogenicity, in silico screens for ICH genetic toxicity assays, reproductive and developmental toxicity, theoretical

  3. Globalization in the pharmaceutical industry, Part II.

    PubMed

    Casadio Tarabusi, C; Vickery, G

    1998-01-01

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

  4. Globalization in the pharmaceutical industry, Part I.

    PubMed

    Casadio Tarabusi, C; Vickery, G

    1998-01-01

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

  5. [Pharmaceutical chemistry in a pharmacy practice].

    PubMed

    Hankó, B; Takácsné, N K

    2001-10-01

    The authors examine the utility and application of pharmaceutical chemistry is taught at the Faculty of Pharmacy, Semmelweis University, in the everyday pharmacy practice. Selected examples of the professional chemical knowledge necessary in different activities of pharmacists (as in drug quality control, storage of medicines, preparation of drugs in pharmacy and their issue (expenditure) to the patient etc.) are reviewed. Their experimental work on determination of expiry of an "ex tempore" prepared medicine demonstrates that it is possible to meet the principles of Good Pharmacy Practice (GPP). The paper is based on certain chapters of diploma work of H. B., tutor T. N. K.

  6. [Pharmaceutical marketers: professional and informative aspects].

    PubMed

    Hevia, A; López-Valpuesta, F J; Vázquez, J A; Castellanos, A

    1993-10-01

    This study tries to know the opinion of pharmaceutical detailers about their profession, as well as their pharmacological knowledge. 75 questionnaires were distributed to an equal number of detailers. The questionnaires were composed of two parts. In the first one, several questions about their profession were posed. In the second one, the questions were about Pharmacology. The main results were that most of them have got only lower degrees; however, they all have carried out training courses in their companies. With regard to pharmacological questions, percentage of success was 61%.

  7. Technology evaluation: ISIS-2503, Isis Pharmaceuticals.

    PubMed

    Morse, M A

    2001-12-01

    ISIS-2503, a 20-mer antisense oligonucleotide that inhibits Ha-Ras expression, is being developed by Isis Pharmaceuticals Inc as a potential treatmentfor cancer, particularly tumors that commonly have abnormalities of Ras function. It is in phase II trials. According to an April 2001 report by Bear Stearns & Co, Elan Corp plc had an unspecified collaboration with Isis for the development of ISIS-2503 [419357], but Isis later clarified that there was no agreement between the two companies and that ISIS-2503 had merely been used for the 'OraSense' joint venture that explores the use of antisense oligonucleotidesfor oral administration [419673].

  8. Financial Times Global Pharmaceutical & Biotechnology Conference 2009.

    PubMed

    Scattereggia, Jennifer

    2010-01-01

    The Financial Times Global Pharmaceutical & Biotechnology conference, held in London, included topics covering the current and future challenges confronting the pharma and biotech industry, and presented possible solutions to those challenges. This conference report highlights selected presentations on the industry challenges for big pharma companies, diversification as a solution to industry problems, overcoming challenges with collaborations and M&As, and the role of emerging markets in the pharma industry. Other subjects discussed included the expected impact of personalized medicine on the industry, the entry of big pharma into the generics market and the problems that are confronting the small pharma and biotech industry.

  9. [Review of effervescent technique in pharmaceutics research].

    PubMed

    Luo, Xiao-Jian; Xin, Hong-Liang; Rao, Xiao-Yong; Xiao, Zhi-Qiang; Gao, Li-Li; Sun, Ting-Ting; Guo, Qi-Li

    2008-04-01

    Effervescent technique, which can accelerate drug disintegration and dissolution, is usually applied in quick release preparations. Along with the development of pharmaceutical technique and theory, effervescent technique is used more and more extensively to adjust the behavior of drug release, such as in sustained and controlled release preparations, pulsatile drug delivery systems, and so on. This review demonstrated the new applying of effervescent technique in effervescent tablets, stomach floating forms, osmotic pump tablets and pulsatile drug delivery systems, adding to the critical common technique of effervescent forms in drug research. This will be benefit for the further research and development of effervescent technique.

  10. Method for microbiological testing of nonsterile pharmaceuticals.

    PubMed

    Bühlmann, X

    1968-12-01

    A method for testing nonsterile pharmaceutical preparations for their microbial content is described. As far as possible, only solid culture media were used to obtain quantitative results. Aqueous and water-soluble products were tested with membrane-filter techniques. Nonfilterable products were first emulsified or suspended and the homogenate was used for examination. In both procedures, the total number of colonies is determined for aerobic bacteria and fungi. Tests for certain undesirable microbial groups were conducted with selected media. The method described is applicable for finished products, bulk products, raw materials, and active ingredients.

  11. How the Pharmaceutical Benefits Scheme began.

    PubMed

    Goddard, Martyn S

    2014-07-07

    Seventy years ago, the Curtin wartime government introduced legislation for a Pharmaceutical Benefits Scheme (PBS). It was a response to the need to provide access to a wave of antibiotic drugs - sulfonamides, streptomycin, penicillin - to the whole population, not only to the minority able to afford them. The scheme was immediately and successfully opposed by doctors and the conservative opposition, which saw in universal health care an underhand plan to nationalise medicine. There were two High Court challenges, two referendums and a constitutional amendment; but it was not until 1960 that Australians had the comprehensive PBS envisaged by Curtin in 1944.

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

    PubMed

    Taylor, Douglas

    2014-11-01

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

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

    NASA Technical Reports Server (NTRS)

    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.

  14. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2011-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

  15. Diffuse pollution of surface water by pharmaceutical products.

    PubMed

    Derksen, J G M; Rijs, G B J; Jongbloed, R H

    2004-01-01

    Pharmaceutical products for humans or animals, as well as their related metabolites (degradation products) end up in the aquatic environment after use. Recent investigations from abroad show that low concentrations of pharmaceuticals are detectable in municipal waste water, surface water, groundwater and even drinking water. Little is known about the effects, and with that the risk, of long term exposure to low concentrations of pharmaceuticals for aquatic organisms. On the basis of the current knowledge, further attention to map the presence and effects of pharmaceutical residues on aquatic organisms is justified. To map the Dutch situation, recently a monitoring program has started.

  16. Price and welfare effects of a pharmaceutical substitution reform.

    PubMed

    Granlund, David

    2010-12-01

    The price effects of the Swedish pharmaceutical substitution reform are analyzed using data for a panel of all pharmaceutical product sold in Sweden in 1997-2007. The price reduction due to the reform was estimated to average 10% and was found to be significantly larger for brand-name pharmaceuticals than for generics. The results also imply that the reform amplified the effect that generic entry has on brand-name prices by a factor of 10. Results of a demand estimation imply that the price reductions increased total pharmaceutical consumption by 8% and consumer welfare by SEK 2.7 billion annually.

  17. The pharmaceutical biochemistry group: where pharmaceutical chemistry meets biology and drug delivery.

    PubMed

    Kalia, Yogeshvar N; Perozzo, Remo; Scapozza, Leonardo

    2012-01-01

    Successful drug discovery and development of new therapeutics is a long, expensive multidisciplinary process needing innovation and the integration of smart cutting edge science and technology to overcome the challenges in taking a drug from the bench to the bedside. The research activities of the Pharmaceutical Biochemistry group span the drug discovery and development process, providing an interface that brings together pharmaceutical chemistry, biochemistry, structural biology, computational chemistry and biopharmaceutics. Formulation and drug delivery are brought into play at an earlier stage when facing the perennial challenge of transforming a potent molecule in vitro into a therapeutic agent in vivo. Concomitantly, drug delivery results can be understood at a molecular level. This broad range of interdisciplinary research activities and competences enables us to address key challenges in modern drug discovery and development, provides a powerful collaborative platform for other universities and the pharmaceutical industry and an excellent training platform for pharmacists and pharmaceutical scientists who will later be involved in drug discovery and development.

  18. IT Governance and the Public Sector: A Survey of Perceptions, Attitudes, and Knowledge of Federal Public Sector IT Employees

    ERIC Educational Resources Information Center

    Martin, David P.

    2013-01-01

    IT governance has become an important topic as both public and private organizations struggle to meet the challenge of aligning complex IT systems with operational needs. Without effective IT governance, organizations fail to gain strategic benefits that come by the proper strategic alignment of IT resources with the larger organizational mission.…

  19. Private Sector Contracting and Democratic Accountability

    ERIC Educational Resources Information Center

    DiMartino, Catherine; Scott, Janelle

    2013-01-01

    Public officials are increasingly contracting with the private sector for a range of educational services. With much of the focus on private sector accountability on cost-effectiveness and student performance, less attention has been given to shifts in democratic accountability. Drawing on data from the state of New York, one of the most active…

  20. Do Sectoral Training Funds Stimulate Training?

    ERIC Educational Resources Information Center

    Kamphuis, Pascal; Glebbeek, Arie C.; Van Lieshout, Harm

    2010-01-01

    Sectoral levelling funds are an arrangement aimed at alleviating a well-known theoretical problem of underinvestment in worker training because of free-rider behaviour of firms. In the Netherlands, collective agreements require firms to participate in such funds in a number of sectors. Using a comprehensive dataset of Dutch firms, we attempt to…

  1. Entrepreneurship Education: Towards an Industry Sector Approach

    ERIC Educational Resources Information Center

    Richardson, Ita; Hynes, Briga

    2008-01-01

    Purpose: The purpose of this paper is to consider the requirements for an industry sector approach to entrepreneurship education--the information and communications technology (ICT) sector. A modified Process Framework for Entrepreneurship Education is presented focusing specifically on ICT. The primary components of the Process Framework are…

  2. Motivating the Private vs. Public Sector Managers.

    ERIC Educational Resources Information Center

    Khojasteh, Mak

    1993-01-01

    A questionnaire on intrinsic/extrinsic rewards received 362 responses from 380 managers. Pay and security were greater motivators for private than for public sector managers. Recognition had higher motivating potential in the public sector. Both groups were motivated by achievement and advancement. (SK)

  3. 33 CFR 84.17 - Horizontal sectors.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... RULES ANNEX I: POSITIONING AND TECHNICAL DETAILS OF LIGHTS AND SHAPES § 84.17 Horizontal sectors. (a)(1... intensities. The intensities shall decrease to reach practical cut-off between 1 and 3 degrees outside the prescribed sectors. (2) For sternlights and masthead lights and at 22.5 degrees abaft the beam for...

  4. 33 CFR 84.19 - Vertical sectors.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... required intensity of electric lights as fitted shall be maintained on the horizontal. (d) In the case of... RULES ANNEX I: POSITIONING AND TECHNICAL DETAILS OF LIGHTS AND SHAPES § 84.19 Vertical sectors. (a) The vertical sectors of electric lights as fitted, with the exception of lights on sailing vessels underway...

  5. 33 CFR 84.19 - Vertical sectors.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... required intensity of electric lights as fitted shall be maintained on the horizontal. (d) In the case of... RULES ANNEX I: POSITIONING AND TECHNICAL DETAILS OF LIGHTS AND SHAPES § 84.19 Vertical sectors. (a) The vertical sectors of electric lights as fitted, with the exception of lights on sailing vessels underway...

  6. 33 CFR 84.19 - Vertical sectors.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... required intensity of electric lights as fitted shall be maintained on the horizontal. (d) In the case of... RULES ANNEX I: POSITIONING AND TECHNICAL DETAILS OF LIGHTS AND SHAPES § 84.19 Vertical sectors. (a) The vertical sectors of electric lights as fitted, with the exception of lights on sailing vessels underway...

  7. 33 CFR 84.19 - Vertical sectors.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... required intensity of electric lights as fitted shall be maintained on the horizontal. (d) In the case of... RULES ANNEX I: POSITIONING AND TECHNICAL DETAILS OF LIGHTS AND SHAPES § 84.19 Vertical sectors. (a) The vertical sectors of electric lights as fitted, with the exception of lights on sailing vessels underway...

  8. 33 CFR 84.17 - Horizontal sectors.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... RULES ANNEX I: POSITIONING AND TECHNICAL DETAILS OF LIGHTS AND SHAPES § 84.17 Horizontal sectors. (a)(1... intensities. The intensities shall decrease to reach practical cut-off between 1 and 3 degrees outside the prescribed sectors. (2) For sternlights and masthead lights and at 22.5 degrees abaft the beam for...

  9. 33 CFR 84.19 - Vertical sectors.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... required intensity of electric lights as fitted shall be maintained on the horizontal. (d) In the case of... RULES ANNEX I: POSITIONING AND TECHNICAL DETAILS OF LIGHTS AND SHAPES § 84.19 Vertical sectors. (a) The vertical sectors of electric lights as fitted, with the exception of lights on sailing vessels underway...

  10. 33 CFR 84.17 - Horizontal sectors.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... RULES ANNEX I: POSITIONING AND TECHNICAL DETAILS OF LIGHTS AND SHAPES § 84.17 Horizontal sectors. (a)(1... intensities. The intensities shall decrease to reach practical cut-off between 1 and 3 degrees outside the prescribed sectors. (2) For sternlights and masthead lights and at 22.5 degrees abaft the beam for...

  11. FORCE Sectoral Survey on European Retail Trade.

    ERIC Educational Resources Information Center

    Bertzeletou, Tina

    1993-01-01

    A sectoral survey focused on ways in which vocational training plans are formulated and analysis of the cost effectiveness of continuing vocational training at the company level. It examined techniques applied to developing continuing vocational training and improving access. National surveys carried out for the retail trade sector revealed…

  12. National Electric Sector Cybersecurity Organization Resource (NESCOR)

    SciTech Connect

    None, None

    2014-06-30

    The goal of the National Electric Sector Cybersecurity Organization Resource (NESCOR) project was to address cyber security issues for the electric sector, particularly in the near and mid-term. The following table identifies the strategies from the DOE Roadmap to Achieve Energy Delivery Systems Cybersecurity published in September 2011 that are applicable to the NESCOR project.

  13. Dark Sectors 2016 Workshop: Community Report

    SciTech Connect

    Alexander, Jim; et al.

    2016-08-30

    This report, based on the Dark Sectors workshop at SLAC in April 2016, summarizes the scientific importance of searches for dark sector dark matter and forces at masses beneath the weak-scale, the status of this broad international field, the important milestones motivating future exploration, and promising experimental opportunities to reach these milestones over the next 5-10 years.

  14. 50 CFR 648.87 - Sector allocation.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... new sector, or fishes pursuant to the provisions of the common pool. (i) GB cod PSC for permits... only fish in a particular stock area, as specified in paragraphs (b)(1)(ii)(A) through (F) of this... penalty shall be applied to any member permit/vessel that leaves that sector to fish under the...

  15. Youth Employment in the Hospitality Sector.

    ERIC Educational Resources Information Center

    Schiller, Bradley R.

    A study used data from the National Longitudinal Surveys of Youth to analyze the long-term effects of hospitality industry employment on youth. The subsample extracted for the study included all youth who were aged 16-24 in 1980 and employed in the civilian sector for pay at any time in the year. Statistics indicated the hospitality sector was…

  16. Mixed-Sector Tertiary Education. Research Overview

    ERIC Educational Resources Information Center

    Moodie, Gavin

    2012-01-01

    This research overview provides the key messages arising from two related projects investigating tertiary education institutions that have recently begun to offer tertiary programs outside the sector of their initial establishment and the sector of the majority of their enrolments. These are TAFE institutes offering higher education programs,…

  17. The Economic Effects of a Booming Sector.

    ERIC Educational Resources Information Center

    Corden, W. M.

    1983-01-01

    Since the 1970s, economists have recognized that a booming export sector of the economy can have unfortunate consequences for other sectors and lead to both appreciation of that nation's currency and a weakening position for its exports. A model to stimulate the effects of this situation is discussed. (IS)

  18. Labor in the Public and Nonprofit Sectors.

    ERIC Educational Resources Information Center

    Hamermesh, Daniel S., Ed.

    Originally presented at a Conference on Labor in Nonprofit Industry and Government held at Princeton University, the studies are the first to provide an economic discussion of the public sector labor market. Melvin Reder examines the effect of the absence of the profit motive on employment and wage determination in the public sector. Orley…

  19. Education and Human Resources Sector Assessment Manual.

    ERIC Educational Resources Information Center

    Pigozzi, Mary Joy; Cieutat, Victor J.

    This manual endorses and adopts the sector-assessment approach for planning and managing the allocation of educational resources. Chapter 1 presents the manual's goals. Chapter 2 describes the manual's content and information sources, explains the term "sector assessment," identifies the groups that benefit from recommendations made by…

  20. TDR collaboration with the pharmaceutical industry.

    PubMed

    Gutteridge, W E

    2006-12-01

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

  1. The pharmaceutical heritage of the Netherlands.

    PubMed

    Bosman-Jelgersma, H A

    1995-01-01

    For the last 40 years the 'Kring voor de Geschiedenis van de Pharmacie in Benelux' (Society for the History of Pharmacy in Benelux) has been studying the pharmaceutical past, in which the pharmacist, the preparer of medicines from way back, occupies an important place. This historical study supplies some unexpected views of the past and the future. Sarton also pointed this out to us in his 'new humanism' (28). In his own words: "The present without its past is insipid and meaningless; the past without the present is obscure. The life of science, like the life of art, is eternal." His new humanism did not result in narrow specialism, but in what he refers to as a 'double Renaissance', which also incorporates nature, culture and man. In this way an inspiring influence emanates from the past and thus our common pharmaceutical heritage can form a link between our nations. In turn this can contribute to the process of evolution which is necessary to realize harmonization within the framework of the European community.

  2. Metaphors and myths in pharmaceutical advertising.

    PubMed

    Delbaere, Marjorie

    2013-04-01

    It should come as no surprise that the ancient Greek word for drug, pharmakon, meant remedy. But this same word also meant poison as well as magical charm. We speak of heart attacks and of a long road to recovery. These meanings and phrases are reflective of how society conceives of illness and medical therapies. Metaphors and myths of magic, sports and journey are prevalent in medical terminology and they permeate pharmaceutical advertising. This research investigates the conceptual metaphors that are present in advertisements for pharmaceuticals, both those directed to consumers as well as those directed to physicians, for a broad range of drugs and medical conditions. This research employed a content analysis of advertisements appearing in popular consumer magazines as well as in physician journals and an analysis of online consumer drug reviews. The research concludes with a discussion of the similarities and differences among the conceptual metaphors in consumer versus physician ads, across different medical conditions, and the impact of specific metaphors on consumers' understanding of illness and drug therapies.

  3. Potentiometric determination of famotidine in pharmaceutical formulations.

    PubMed

    Ayad, Magda M; Shalaby, Abdalla; Abdellatef, Hisham E; Elsaid, Heba M

    2002-06-20

    Two new potentiometric methods for determination of famotidine in pure form and in its pharmaceutical tablet form are developed. In the first method, the construction of plasticised poly(vinyl chloride) (PVC) matrix-type famotidine ion-selective membrane electrode and its use in the potentiometric determination of famotidine in pharmaceutical preparations are described. It is based on the use of the ion-associate species, formed by famotidine cation and tetraphenyl borate (TPB) counterion. The electrode exhibited a linear response for 1 x 10(-3)-1 x 10(-5) M of famotidine solutions over the pH range 1-5 with an average recovery of 99.26% and mean standard deviation of 1.12%. Common organic and inorganic cations showed negligible interference. In the second method, the conditions for the oxidimetric titration of famotidine have been studied. The method depends on using lead(IV) acetate for oxidation of the thioether contained in famotidine. The titration takes place in presence of catalytic quantities of potassium bromide (KBr). Direct potentiometric determination of 1.75 x 10(-2) M famotidine solution showed an average recovery of 100.51% with a mean standard deviation of 1.26%. The two methods have been applied successfully to commercial tablet. The results obtained reveal good percentage recoveries, which are in good agreement with those obtained by the official methods.

  4. Old Yet New--Pharmaceuticals from Plants

    NASA Astrophysics Data System (ADS)

    Houghton, Peter J.

    2001-02-01

    Plants or their crude extracts have been used since prehistory to treat human ailments. Plants are still used in this way in many parts of the world, but Western scientific medicine has tended to isolate active compounds, or make derivatives of them, for use as drugs. Compounds produced by the plant have been important pharmaceuticals since the isolation of morphine almost two hundred years ago and new naturally occurring compounds such as paclitaxel are continually being introduced commercially. Bioactive molecules may also be produced from chemicals found in plants by chemical modification using synthetic chemistry or microorganisms (as in the production of steroids). A third major contribution of plant chemicals to drugs is their utilization as templates for the design of new compounds made by synthesis (e.g. the discovery of aspirin and related compounds from substances in willow bark). New pharmaceuticals from plants are being discovered by examining traditional medicines and by large-scale bioassay screening processes. In addition, the chemical survival systems of plants that exist in hostile environments are receiving increasing attention as leads to discover active compounds. The knowledge of botanical relationships helps find new sources of known compounds of interest and novel compounds with similar structures from related species. Future prospects for the discovery of new compounds from plants are broadened by the new technologies of gene manipulation, tissue culture, and combinatorial chemistry, so it is very likely that natural products from plants will continue to play an important role in the fight against disease.

  5. UPLC: a preeminent technique in pharmaceutical analysis.

    PubMed

    Kumar, Ashok; Saini, Gautam; Nair, Anroop; Sharma, Rishbha

    2012-01-01

    The pharmaceutical companies today are driven to create novel and more efficient tools to discover, develop, deliver and monitor the drugs. In this contest the development of rapid chromatographic method is crucial for the analytical laboratories. In precedent decade, substantial technological advances have been done in enhancing particle chemistry performance, improving detector design and in optimizing the system, data processors and various controls of chromatographic techniques. When all was blended together, it resulted in the outstanding performance via ultra-high performance liquid chromatography (UPLC), which holds back the principle of HPLC technique. UPLC shows a dramatic enhancement in speed, resolution as well as the sensitivity of analysis by using particle size less than 2 pm and the system is operational at higher pressure, while the mobile phase could be able to run at greater linear velocities as compared to HPLC. This technique is considered as a new focal point in field of liquid chromatographic studies. This review focuses on the basic principle, instrumentation of UPLC and its advantages over HPLC, furthermore, this article emphasizes various pharmaceutical applications of this technique.

  6. Automatic conceptual indexing of French pharmaceutical theses.

    PubMed

    Mary, Vincent; Pouliquen, Bruno; Le Duff, Franck; Darmoni, Stefan J; Segui, Alain; Le Beux, Pierre

    2002-01-01

    French pharmaceutical theses are rarely quoted. If the main obstacles originate from language or access barriers, proper indexation could also be blamed. Manually extracted key-words don't necessary come from a structured thesaurus. In the following work, this manual indexing method is compared to an automated one, "Nomindex", based on UMLS. The automated method is improved by the addition of a relevance scoring system. The first indexing step consists of downloading, adapting and indexing theses in electronic format. Results will then be analyzed and sorted by relevance, through the comparison of classic statistical indices (noise, silence and relevance). It was assumed that the manually obtained key-words were always relevant. The silence of manual indexing is nevertheless high: seven new key-words are proposed by Nomindex, which results are mixed (10% of silence, but 50% of noise). These results are promising on the first experiment on pharmaceutical document without lexicon improvement. The indexing, if it is currently insufficient for a real life use, could easily be improved by specific updates of the lexicon.

  7. [Challenges and opportunities for the development of a national pharmaceutical policy in México].

    PubMed

    Wirtz, Veronika J; Dreser, Anahí; Heredia-Pi, Ileana

    2013-01-01

    Unlike many other Latin American countries Mexico has no coherent and explicit national pharmaceutical policy (NPP). Other national challenges are: high out-of-pocket expenditure on medicines despite the implementation of universal health care coverage through Seguro Popular, high prices of medicines in the private sector in comparison to other countries when adjusted for income level, and the lack of clear strategies to improve safety and efficiency in the use of medicines, in particular interventions aimed at private physicians, pharmacies and consumers. The aim of this paper is to describe the challenges and opportunities to (1) consolidate the processes of formulating, implementing and evaluating NPP, and (2) define the policy content with regard to access and use of medicines.

  8. Community Perception Survey, 2001.

    ERIC Educational Resources Information Center

    Rasmussen, Patricia; Silverman, Barbara

    This document is a report on the 2001 Community Perception Survey administered by Mt. San Antonio College (SAC) (California). The survey gathered public perception data of SAC services and programs. The survey was mailed to 773 service area community leaders; 160 (21%) responded. Survey results showed that: (1) 70% had knowledge of SAC programs…

  9. Studying Sensory Perception.

    ERIC Educational Resources Information Center

    Ackerly, Spafford C.

    2001-01-01

    Explains the vestibular organ's role in balancing the body and stabilizing the visual world using the example of a hunter. Describes the relationship between sensory perception and learning. Recommends using optical illusions to illustrate the distinctions between external realities and internal perceptions. (Contains 13 references.) (YDS)

  10. Distance Perception within Europe.

    ERIC Educational Resources Information Center

    Eysberg, Cees D.

    1985-01-01

    A distance perception survey was used to get college students enrolled in a human geography course involved and interested in the topic of perception. Students were asked to arrange 12 European capitals in sequence according to their distance from Amsterdam. Survey results are presented. (RM)

  11. The Trans Pacific Partnership Agreement and Pharmaceutical Regulation in Canada and Australia.

    PubMed

    Lexchin, Joel; Gleeson, Deborah

    2016-10-01

    The Trans Pacific Partnership Agreement (TPP) is a large regional trade agreement involving 12 countries. It was signed in principle in February 2016 but has not yet been ratified in any of the participating countries. The TPP provisions place a range of constraints on how governments regulate the pharmaceutical sector and set prices for medicines. This article presents a prospective policy analysis of the possible effects of the TPP on these two points in Canada and Australia. Five chapters of relevance to pharmaceutical policy are analyzed: chapters on Technical Barriers to Trade (Chapter 8), Intellectual Property (Chapter 18), Investment (Chapter 9), Dispute Resolution (Chapter 28), and an annex of the chapter on Transparency and Anti-Corruption (Chapter 26, Annex 26-A). The article concludes that the TPP could have profound effects on the criteria these countries use to decide on drug safety and effectiveness, how new drugs are approved (or not) for marketing, post-market surveillance and inspection, the listing of drugs on public formularies, and how individual drugs are priced in the future. Furthermore, the TPP, if ratified and enforced, will reduce future policy flexibility to address the increasing challenge of rising drug prices.

  12. Early Introduction to Professional and Ethical Dilemmas in a Pharmaceutical Care Laboratory Course

    PubMed Central

    2015-01-01

    Objective. To study the effects of an early professional development series in a pharmaceutical care laboratory (PCL) course on first-year pharmacy students’ perceptions of the importance of professional attitudes and action. Design. Three hundred thirty-four first-year students enrolled in a PCL course participated in a new required learning activity centered on development of professional attitudes and behaviors. Students discussed situational dilemmas in pharmacy practice in small groups, highlighting application of the Oath of a Pharmacist and the Pharmacists’ Code of Ethics. Assessment. Students completed an optional questionnaire at the beginning and end of the semester to assess change in their attitudes and behaviors related to professionalism in pharmacy practice. Conclusion. While students entered their training with a strong appreciation for professionalism, they felt more confident in applying the Oath of a Pharmacist and the Pharmacists Code of Ethics to dilemmas in practice following the new learning activity. PMID:26889068

  13. Dimensions of the Independent Sector: A Statistical Profile. Second Edition.

    ERIC Educational Resources Information Center

    Hodgkinson, Virginia Ann; Weitzman, Murray S.

    The second in a biennial series of statistical profiles of the independent sector (voluntary sector, third sector, or nonprofit sector) describes and charts the activities of groups and individuals associated with this sector. Included are voluntary organizations, foundations, the social responsibility programs of corporations, and people who…

  14. [Accident risk perception in high-voltage electrical maintenance workers].

    PubMed

    Micheli, M; Zanaletti, W; Giorgi, I; Argentero, P; Candura, S M

    2006-01-01

    Promoting safety at work represents a fundamental task for achieving improvement in the quality of working life and preventing accidental injuries at work. Nevertheless, over the last few decades injuries at work have continued to constitute a significant problem. The aim of this study was to examine accident risk perception in a sample of 45 subjects employed in the electricity sector and to relate their risk perception to personality characteristics, cognitive functioning, and personal and professional history. The instruments used were: "Cognitive Behavioral Assessment 2.0", the "Workplace safety questionnaire" (an Italian questionnaire on safety at work), and a battery of neuropsychological tests. Findings show that electricity (current variability) was perceived as the most serious risk factor, while the most frequent perceived risk factors for accidents were accidental falls, cuts and bruises. The subjects of our sample showed a good awareness of risk perception, and good mood response and augmented psychophysiological activation during accidental injuries.

  15. Air Traffic Sector Configuration Change Frequency

    NASA Technical Reports Server (NTRS)

    Chatterji, Gano B.; Drew, Michael

    2010-01-01

    A Mixed Integer Linear Programming method is used for creating sectors in Fort Worth, Cleveland, and Los Angeles centers based on several days of good-weather traffic data. The performance of these sectors is studied when they are subjected to traffic data from different days. Additionally, the advantage of using different sector designs at different times of day with varying traffic loads is examined. Specifically, traffic data from 10 days are used for design, and 47 other days are played back to test if the traffic-counts stay below the design values used in creating the partitions. The primary findings of this study are as follows. Sectors created with traffic from good-weather days can be used on other good-weather days. Sector configurations created with two hours of traffic can be used for 6 to 12 hours without exceeding the peak-count requirement. Compared to using a single configuration for the entire day, most of the sector-hour reduction is achieved by using two sector configurations -one during daytime hours and one during nighttime hours.

  16. Pharmaceutical Concern and Prioritization Framework for Aquatic Life Effects

    EPA Science Inventory

    Human pharmaceuticals and veterinary drugs are being developed and used at an increasing rate world-wide. This, and increasingly sensitive analytical techniques, have lead to recurrent detection of pharmaceuticals as environmental pollutants. The goal of the present work was to d...

  17. The pharmaceutical care in asthma - Polish and global perspective.

    PubMed

    Swieczkowski, Damian; Poniatowski, Patryk; Merks, Piotr; Jaguszewski, Milosz

    2016-01-01

    The pharmaceutical care is a pharmacist's contribution to the care of individual patients and leads to optimize the use of drugs. The pharmaceutical care may improve adherence, clinical effectiveness of providing therapy and improve the health-related quality of life. The conducted literature review confirmed that pharmaceutical care and advanced pharmaceutical services are clinical effective in asthma. The implementation of pharmaceutical care under Polish conditions is currently insufficient and remains challenging for the future. Herein we should admit, that the polish government has recently put an effort to appoint specially dedicated team establishing a program of reimbursed pharmaceutical care. This move should be considered as a new phase for amendments community pharmacy in Poland. The experience of different health care systems, including for instance United Kingdom, Australia or Canada, might be used in the process of changing Polish perspective. Herein, we have reviewed the literature and highlighted the services creating the program of pharmaceutical care in asthma. This unique work describes the complex nature of optimal pharmaceutical services emphasizing the strong necessity of multidimensional approach in this field.

  18. Biotechnology, nanotechnology, and pharmacogenomics and pharmaceutical compounding, Part 1.

    PubMed

    Allen, Loyd V

    2015-01-01

    The world of pharmaceuticals is changing rapidly as biotechnology continues to grow and nanotechnology appears on the horizon. Biotechnology is gaining in importance in extemporaneous pharmaceutical compounding, and nanotechnology and pharmacogenomics could drastically change the practice of pharmacy. This article discusses biotechnology and the factors to consider when compounding biotechnology drugs.

  19. 42 CFR 482.25 - Condition of participation: Pharmaceutical services.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a... the hospital's organized pharmaceutical service. (a) Standard: Pharmacy management and administration. The pharmacy or drug storage area must be administered in accordance with accepted...

  20. 42 CFR 482.25 - Condition of participation: Pharmaceutical services.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a... the hospital's organized pharmaceutical service. (a) Standard: Pharmacy management and administration. The pharmacy or drug storage area must be administered in accordance with accepted...

  1. The Third Wave in Pharmaceutical Education: The Clinical Movement.

    ERIC Educational Resources Information Center

    Hepler, Charles D.

    1987-01-01

    Pharmaceutical education and pharmaceutical practice began to diverge in the early twentieth century for socioeconomic reasons and have since grown along separate paths. The movement toward clinical pharmacy, emerging about 1970, may reunite the two but it first faces new challenges. (MSE)

  2. Recommendations on the environmental risk assessment of pharmaceuticals: Effect characterization.

    PubMed

    Schmitt, Heike; Boucard, Tatiana; Garric, Jeanne; Jensen, John; Parrott, Joanne; Péry, Alexandre; Römbke, Jörg; Straub, Jürg Oliver; Hutchinson, Thomas H; Sánchez-Argüello, Paloma; Wennmalm, Ake; Duis, Karen

    2010-07-01

    The effects testing of pharmaceuticals consists of a tiered investigation of ecotoxicological endpoints. However, effects testing has to be performed only when the predicted environmental concentrations (PECs) of pharmaceuticals are above certain action limits. To study the appropriateness of these action limits, a literature search was performed for pharmaceuticals with predicted no-effect concentrations (PNECs) close to or below the action limits. Some human pharmaceuticals showed effects at concentrations ≤100 ng/L, mostly in nonstandard fish or invertebrate tests. In addition, antibiotics and parasiticides sometimes had effects at concentrations <10  mg/kg soil. To help in identifying pharmaceuticals that should undergo effects testing although their PECs are below the action limits, "however clauses" are postulated for pharmaceuticals that are potentially persistent, bioaccumulative, carcinogenic, mutagenic, or reproductively toxic. Effects testing should also be performed for pharmaceuticals that 1) affect target structures that are conserved across species, 2) have a high potency or a small therapeutic margin, 3) are from a new therapeutic class, and 4) are structurally similar to compounds with known effects. Furthermore, suggestions for improving the effects testing of pharmaceuticals are made. These include inter alia chronic effects testing as a general approach, the use of invertebrate tests including sexual reproduction, the application of endpoints reflecting the mode of action of the drug or known side effects, and the simulation of more realistic exposure conditions in terrestrial laboratory tests.

  3. Introductory Level Problems Illustrating Concepts in Pharmaceutical Engineering

    ERIC Educational Resources Information Center

    McIver, Keith; Whitaker, Kathryn; De Delva, Vladimir; Farrell, Stephanie; Savelski, Mariano J.; Slater, C. Stewart

    2012-01-01

    Textbook style problems including detailed solutions introducing pharmaceutical topics at the level of an introductory chemical engineering course have been created. The problems illustrate and teach subjects which students would learn if they were to pursue a career in pharmaceutical engineering, including the unique terminology of the field,…

  4. Astronaut William Gregory works with pharmaceutical experiments on middeck

    NASA Technical Reports Server (NTRS)

    1995-01-01

    Astronaut William G. Gregory, STS-67 pilot, works with a pharmaceutical experiment on the middeck of the Earth-orbiting Space Shuttle Endeavour. Commercial Materials Dispersion Apparatus Instruments Technology Associates Experiments (CMIX-03) includes not only pharmaceutical but also biotechnology, cell biology, fluids and crystal growth investigations.

  5. Ways of Learning in the Pharmaceutical Sales Industry

    ERIC Educational Resources Information Center

    Hunter, Carrie Patricia

    2010-01-01

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

  6. Pharmaceutical Sales--An Experiential Learning Elective Course.

    ERIC Educational Resources Information Center

    Scribner, William; And Others

    1979-01-01

    To provide an opportunity for pharmacy students to acquire a better understanding of the medical service representative's functions as a member of the pharmaceutical industries' marketing force, a practice experience elective course in pharmaceutical sales was developed at the University of Cincinnati. Course planning and implementation are…

  7. Pharmaceutical prices continue to drive up supply costs.

    PubMed

    Hard, R

    1992-03-05

    The 1992 purchasing outlook from the Joint Purchasing Corp. (JPC), New York City, forecasts a difficult winter followed by a mild economic recovery beginning in the spring or early summer. Pharmaceuticals, however, are forecast to undergo significant price increases, due in part to hospital pharmaceutical price hikes associated with the ramifications of the 1990 Medicaid drug rebate legislation passed by Congress.

  8. 77 FR 30326 - Importer of Controlled Substances; Notice Of Registration; Mylan Pharmaceuticals, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-22

    ... Enforcement Administration Importer of Controlled Substances; Notice Of Registration; Mylan Pharmaceuticals... 12620, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, made... registration of Mylan Pharmaceuticals, Inc. to import the basic classes of controlled substances is...

  9. 78 FR 19016 - Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-28

    ... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals... FR 72409, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, made... Mylan Pharmaceuticals, Inc. to import the basic classes of controlled substances is consistent with...

  10. 77 FR 34072 - Importer of Controlled Substances; Notice of Registration; Meda Pharmaceuticals, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-08

    ... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Meda Pharmaceuticals... 21998, Meda Pharmaceuticals, Inc., 705 Eldorado Street, Decatur, Illinois 62523, made application by... Pharmaceuticals Inc. to import the basic class of controlled substance is consistent with the public interest,...

  11. 77 FR 12621 - Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals... FR 81978, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, made...), and determined that the registration of Mylan Pharmaceuticals, Inc. to import the basic classes...

  12. 75 FR 54627 - Best Management Practices for Unused Pharmaceuticals at Health Care Facilities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-08

    ... AGENCY Best Management Practices for Unused Pharmaceuticals at Health Care Facilities AGENCY... guidance document entitled, Best Management Practices for Unused Pharmaceuticals at Health Care Facilities... been studying unused pharmaceutical disposal practices at health care facilities, prompted by...

  13. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants of new drug... Research's (CDER's) current thinking on the appropriate regulatory classification of pharmaceutical...

  14. 75 FR 33824 - Pharmaceutical Products and Chemical Intermediates, Fourth Review: Advice Concerning the Addition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-15

    ... COMMISSION Pharmaceutical Products and Chemical Intermediates, Fourth Review: Advice Concerning the Addition of Certain Products to the Pharmaceutical Appendix to the HTS AGENCY: United States International... (Commission) instituted investigation No. 332-520, Pharmaceutical Products and Chemical Intermediates,...

  15. 78 FR 33441 - Importer of Controlled Substances; Notice of Registration; Caraco Pharmaceutical Laboratories, LTD

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-04

    ... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Caraco Pharmaceutical..., 78 FR 12101, Caraco Pharmaceutical Laboratories, Ltd., 270 Prospect Plains Road, Cranbury, New Jersey... registration of Caraco Pharmaceutical Laboratories, Ltd., to import the basic class of controlled substance...

  16. 77 FR 75672 - Manufacturer of Controlled Substances, Notice of Registration, Halo Pharmaceutical, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-21

    ... Enforcement Administration Manufacturer of Controlled Substances, Notice of Registration, Halo Pharmaceutical... 47114, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey 07981, made application... determined that the registration of Halo Pharmaceutical, Inc., to manufacture the listed basic classes...

  17. 75 FR 15642 - Schedules of Controlled Substances: Exempted Prescription Product; River Edge Pharmaceutical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-30

    ... Prescription Product; River Edge Pharmaceutical, Servira AGENCY: Drug Enforcement Administration (DEA... one new application for exemption for River Edge Pharmaceutical's Servira . Having reviewed this... Pharmaceutical's Servira (NDC Code 68032-256) tablets containing 48.6 mg phenobarbital in combination...

  18. 77 FR 16264 - Manufacturer of Controlled Substances, Notice of Registration; Halo Pharmaceutical Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... Enforcement Administration Manufacturer of Controlled Substances, Notice of Registration; Halo Pharmaceutical... FR 77850, Halo Pharmaceutical Inc., 30 North Jefferson Road, Whippany, New Jersey 07981, made... determined that the registration of Halo Pharmaceutical Inc. to manufacture the listed basic classes...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-19

    ... Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent Orders... Consent Orders (``Consent Agreement'') from Teva Pharmaceutical Industries Ltd. (``Teva'') and Cephalon... Pharmaceutical, Inc. (``Par'') all of Teva's rights and assets relating to its generic transmucosal...

  20. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2005-01-01

    This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products and related materials and draft guidelines for registration of fixed-dose combination medicinal products.

  1. Membrane Bioprocesses for Pharmaceutical Micropollutant Removal from Waters

    PubMed Central

    de Cazes, Matthias; Abejón, Ricardo; Belleville, Marie-Pierre; Sanchez-Marcano, José

    2014-01-01

    The purpose of this review work is to give an overview of the research reported on bioprocesses for the treatment of domestic or industrial wastewaters (WW) containing pharmaceuticals. Conventional WW treatment technologies are not efficient enough to completely remove all pharmaceuticals from water. Indeed, these compounds are becoming an actual public health problem, because they are more and more present in underground and even in potable waters. Different types of bioprocesses are described in this work: from classical activated sludge systems, which allow the depletion of pharmaceuticals by bio-degradation and adsorption, to enzymatic reactions, which are more focused on the treatment of WW containing a relatively high content of pharmaceuticals and less organic carbon pollution than classical WW. Different aspects concerning the advantages of membrane bioreactors for pharmaceuticals removal are discussed, as well as the more recent studies on enzymatic membrane reactors to the depletion of these recalcitrant compounds. PMID:25295629

  2. Scientific Knowledge and Technology, Animal Experimentation, and Pharmaceutical Development.

    PubMed

    Kinter, Lewis B; DeGeorge, Joseph J

    2016-12-01

    Human discovery of pharmacologically active substances is arguably the oldest of the biomedical sciences with origins >3500 years ago. Since ancient times, four major transformations have dramatically impacted pharmaceutical development, each driven by advances in scientific knowledge, technology, and/or regulation: (1) anesthesia, analgesia, and antisepsis; (2) medicinal chemistry; (3) regulatory toxicology; and (4) targeted drug discovery. Animal experimentation in pharmaceutical development is a modern phenomenon dating from the 20th century and enabling several of the four transformations. While each transformation resulted in more effective and/or safer pharmaceuticals, overall attrition, cycle time, cost, numbers of animals used, and low probability of success for new products remain concerns, and pharmaceutical development remains a very high risk business proposition. In this manuscript we review pharmaceutical development since ancient times, describe its coevolution with animal experimentation, and attempt to predict the characteristics of future transformations.

  3. Artificial neural networks: theoretical background and pharmaceutical applications: a review.

    PubMed

    Wesolowski, Marek; Suchacz, Bogdan

    2012-01-01

    In recent times, there has been a growing interest in artificial neural networks, which are a rough simulation of the information processing ability of the human brain, as modern and vastly sophisticated computational techniques. This interest has also been reflected in the pharmaceutical sciences. This paper presents a review of articles on the subject of the application of neural networks as effective tools assisting the solution of various problems in science and the pharmaceutical industry, especially those characterized by multivariate and nonlinear dependencies. After a short description of theoretical background and practical basics concerning the computations performed by means of neural networks, the most important pharmaceutical applications of neural networks, with suitable references, are demonstrated. The huge role played by neural networks in pharmaceutical analysis, pharmaceutical technology, and searching for the relationships between the chemical structure and the properties of newly synthesized compounds as candidates for drugs is discussed.

  4. Occurrence and treatment efficiency of pharmaceuticals in landfill leachates.

    PubMed

    Lu, Mu-Chen; Chen, Yao Yin; Chiou, Mei-Rung; Chen, Men Yu; Fan, Huan-Jung

    2016-09-01

    Landfill leachates might contain pharmaceuticals due to the expired or unwanted drugs were disposed of at landfills. These pharmaceuticals might pose a threat to soil and groundwater. Therefore, this study investigated the distributions of pharmaceutical residues and toxicities among four typical municipal landfill leachates. Twenty six pharmaceuticals were investigated in this study and fifteen of them were found in all samples from four leachates. In addition, ampicillin and methylenedioxymethamphetamine (MDMA) were detected in urban landfills (A1 and A2) but were not in rural and suburb landfills (B and C). On the other hand, some compounds were much more abundant in suburb/rural landfill leachates than those in urban landfills including diclofenac, gemfibrozil and amphetamine. Landfill leachate treatment plants could not remove most of the pharmaceuticals effectively. Landfill leachates without proper treatments would have significant adverse health impacts on human and aquatic life.

  5. Acid deposition research in the private sector

    SciTech Connect

    Kinsman, J.D.; Wisniewski, J.; Nelson, J.

    1984-02-01

    Acid deposition research funded by the private sector since 1980 is reviewed. Types of studies (e.g., atmospheric processes, emissions and monitoring, environmental effects) supported by the private sector during this period are overviewed. The specific industries/organizations (e.g., electric utility industry, environmental interest groups) funding reserach during 1980-1982 are discussed, with relation to the number of studies supported and funds (by year) provided by each. Finally, 13 research projects supported by the private sector and initiated by December 1983, each at greater than $1 million, are described.

  6. Perception of trigeminal mixtures.

    PubMed

    Filiou, Renée-Pier; Lepore, Franco; Bryant, Bruce; Lundström, Johan N; Frasnelli, Johannes

    2015-01-01

    The trigeminal system is a chemical sense allowing for the perception of chemosensory information in our environment. However, contrary to smell and taste, we lack a thorough understanding of the trigeminal processing of mixtures. We, therefore, investigated trigeminal perception using mixtures of 3 relatively receptor-specific agonists together with one control odor in different proportions to determine basic perceptual dimensions of trigeminal perception. We found that 4 main dimensions were linked to trigeminal perception: sensations of intensity, warmth, coldness, and pain. We subsequently investigated perception of binary mixtures of trigeminal stimuli by means of these 4 perceptual dimensions using different concentrations of a cooling stimulus (eucalyptol) mixed with a stimulus that evokes warmth perception (cinnamaldehyde). To determine if sensory interactions are mainly of central or peripheral origin, we presented stimuli in a physical "mixture" or as a "combination" presented separately to individual nostrils. Results showed that mixtures generally yielded higher ratings than combinations on the trigeminal dimensions "intensity," "warm," and "painful," whereas combinations yielded higher ratings than mixtures on the trigeminal dimension "cold." These results suggest dimension-specific interactions in the perception of trigeminal mixtures, which may be explained by particular interactions that may take place on peripheral or central levels.

  7. Particle-size analysis of pharmaceutical powders.

    PubMed

    Beaubien, L J; Vanderwielen, A J

    1980-06-01

    An automated electrolytic sensing zone (electrozone) method was developed to determine the particle-size distribution of milled and micronized pharmaceutical powders. The powdered drugs obeyed log-normal statistics, and the distributions were well defined by thier geometric volume mean diameter and the geometric standard deviation. The results show that accurate data can be obtained between 2 and 80 micron with a precision of approximately 0.5 micron. Pulse-width analyses were performed to determine the feasibility of using a pulse-width discrimination program. However, in this case, the program discriminates against real particles and, therefore, its usefulness is limited. Milled and micronized materials are described adequately by a spherical diameter, and the automated electrozone system described is an excellent method for quality control purposes.

  8. The pharmaceutical death-ride of dihydroartemisinin

    PubMed Central

    2010-01-01

    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? PMID:20649950

  9. The ethics and economics of pharmaceutical pricing.

    PubMed

    Parker-Lue, Sara; Santoro, Michael; Koski, Greg

    2015-01-01

    The cost of drugs is a major and rapidly rising component of health-care expenditures. We survey recent literature on the ethics and economics of skyrocketing pharmaceutical prices and find that advances in economic research have increased the sharpness and focus of the ethically based calls to increase access by modifying patent protection and reducing prices. In some cases, research supports ethical arguments for broader access. Other research suggests that efforts to broaden access result in unintended consequences for innovation and the medical needs of patients. Both ethicists and economists need to be more cognizant of the real clinical settings in which physicians practice medicine with real patients. Greater cross-disciplinary interaction among economists, ethicists, and physicians can help reduce the disjunction between innovation and access and improve access and patient care. This dialogue will impact private industry and may spur new multistakeholder paradigms for drug discovery, development, and pricing.

  10. OTI-010 Osiris Therapeutics/JCR Pharmaceuticals.

    PubMed

    Taupin, Philippe

    2006-05-01

    Osiris Therapeutics is developing the donor-derived mesenchymal stem cell (MSC) therapy OTI-010, which repopulates the bone marrow stroma and thus supports engraftment of hematopoietic stem cells from the same donor. This stem cell therapy, which has been awarded Orphan Drug status, is currently in development for the potential enhancement of bone marrow transplants in cancer patients, for the prevention of graft versus host disease (GVHD), and for the treatment of Crohn's disease. Japanese licensee JCR Pharmaceuticals is investigating the therapy for the potential treatment of GVHD in patients undergoing bone marrow transplantation to treat leukemia. Phase II clinical trials in acute gastrointestinal GVHD and in adult and pediatric patients with treatment-refractory severe GVHD are currently underway.

  11. Pharmaceutical advertising and Medicare Part D.

    PubMed

    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.

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

    PubMed

    Roos, J C

    1999-08-07

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

  13. Regulating pharmaceutical advertising: what will work?

    PubMed

    Shapiro, M F

    1997-02-01

    As Dr. Joel Lexchin makes painfully obvious in this issue (see pages 351 to 356), regulatory processes governing pharmaceutical advertising in Canada and elsewhere are seriously compromised. However, the remedial measures Lexchin proposes are not sufficient. Financial sanctions against improper advertising are likely to be regarded by manufacturers as the cost of doing business, and any regulatory body that includes drug industry representatives or individuals receiving financial support from the drug industry cannot be genuinely independent. Moreover, manufacturers are now using promotional strategies that are particularly difficult to regulate. These include providing drugs at lower than the usual cost to ensure their inclusion in managed-care formularies, and using direct-to-consumer advertising to take advantage of the public's lack of sophistication in interpreting scientific evidence. Our best hope of counteracting the power and influence of the drug industry lies in regulation by government agencies, whose interest is the protection of the public.

  14. Quantitative risk modelling for new pharmaceutical compounds.

    PubMed

    Tang, Zhengru; Taylor, Mark J; Lisboa, Paulo; Dyas, Mark

    2005-11-15

    The process of discovering and developing new drugs is long, costly and risk-laden. Faced with a wealth of newly discovered compounds, industrial scientists need to target resources carefully to discern the key attributes of a drug candidate and to make informed decisions. Here, we describe a quantitative approach to modelling the risk associated with drug development as a tool for scenario analysis concerning the probability of success of a compound as a potential pharmaceutical agent. We bring together the three strands of manufacture, clinical effectiveness and financial returns. This approach involves the application of a Bayesian Network. A simulation model is demonstrated with an implementation in MS Excel using the modelling engine Crystal Ball.

  15. Are Pharmaceutical Patents Protected By Human Rights?

    PubMed Central

    Millum, Joseph

    2016-01-01

    The International Bill of Rights enshrines a right to health, which includes a right to access essential medicines. This right frequently appears to conflict with the intellectual property regime that governs pharmaceutical patents. However, there is also a human right that protects creative works, including scientific productions. Does this right support intellectual property protections, even when they may negatively affect health? This article examines the recent attempt by the Committee on Economic, Social and Cultural Rights to resolve this issue and argues that it fails. This is problematic because it means defenders of the present patent regime can continue using human rights documents to support their position. I offer a new framework for resolving the problem by examining the values that underlie human rights. PMID:18974405

  16. Pharmaceutical applications of dynamic mechanical thermal analysis.

    PubMed

    Jones, David S; Tian, Yiwei; Abu-Diak, Osama; Andrews, Gavin P

    2012-04-01

    The successful development of polymeric drug delivery and biomedical devices requires a comprehensive understanding of the viscoleastic properties of polymers as these have been shown to directly affect clinical efficacy. Dynamic mechanical thermal analysis (DMTA) is an accessible and versatile analytical technique in which an oscillating stress or strain is applied to a sample as a function of oscillatory frequency and temperature. Through cyclic application of a non-destructive stress or strain, a comprehensive understanding of the viscoelastic properties of polymers may be obtained. In this review, we provide a concise overview of the theory of DMTA and the basic instrumental/operating principles. Moreover, the application of DMTA for the characterization of solid pharmaceutical and biomedical systems has been discussed in detail. In particular we have described the potential of DMTA to measure and understand relaxation transitions and miscibility in binary and higher-order systems and describe the more recent applications of the technique for this purpose.

  17. Marine Polysaccharides in Pharmaceutical Applications: An Overview

    PubMed Central

    Laurienzo, Paola

    2010-01-01

    The enormous variety of polysaccharides that can be extracted from marine plants and animal organisms or produced by marine bacteria means that the field of marine polysaccharides is constantly evolving. Recent advances in biological techniques allow high levels of polysaccharides of interest to be produced in vitro. Biotechnology is a powerful tool to obtain polysaccharides from a variety of micro-organisms, by controlling the growth conditions in a bioreactor while tailoring the production of biologically active compounds. Following an overview of the current knowledge on marine polysaccharides, with special attention to potential pharmaceutical applications and to more recent progress on the discovering of new polysaccharides with biological appealing characteristics, this review will focus on possible strategies for chemical or physical modification aimed to tailor the final properties of interest. PMID:20948899

  18. Price competition in the Chinese pharmaceutical market.

    PubMed

    Wang, Y Richard

    2006-06-01

    We study price competition between high-quality global products and low-quality local products in a developing country, i.e., China, Nearly all previous studies on pharmaceutical price competition focused on developed countries with bioequivalent generics. In China, local generic products are not bioequivalent and are deemed of lower quality, while global products in the same class are considered similar in quality and better substitutes. We hypothesize that local generic competition drives down local product price but not global product price. In addition, we hypothesize that therapeutic competition among similar global products lowers global product price. Our empirical results support both hypotheses. Number of local generic competitors has a significantly negative effect on local product price but no effect on global product price, while number of global therapeutic competitors has a significantly negative effect on global product price. Policy changes that encourage bioequivalent local products and accelerate global product approvals will enhance price competition in China.

  19. Advancing drug discovery: a pharmaceutics perspective.

    PubMed

    Kwong, Elizabeth

    2015-03-01

    Current industry perspective of how discovery is conducted seems to be fragmented and does not have a unified overall outlook of how discovery challenges are being addressed. Consequently, well-defined processes and drug-likeness criteria are being viewed as "broken" and will not maintain future R&D productivity. In this commentary, an analysis of existing practices for defining successful development candidates resulted in a 5 "must do" list to help advance Drug Discovery as presented from a Pharmaceutics perspective. The 5 "must do" list includes: what an ideal discovery team model should look like, what criteria should be considered for the desired development candidate profile, what the building blocks of the development candidate should look like, and how to assess the development risks of the candidate.

  20. Pharmaceutical Particle Engineering via Spray Drying

    PubMed Central

    2007-01-01

    This review covers recent developments in the area of particle engineering via spray drying. The last decade has seen a shift from empirical formulation efforts to an engineering approach based on a better understanding of particle formation in the spray drying process. Microparticles with nanoscale substructures can now be designed and their functionality has contributed significantly to stability and efficacy of the particulate dosage form. The review provides concepts and a theoretical framework for particle design calculations. It reviews experimental research into parameters that influence particle formation. A classification based on dimensionless numbers is presented that can be used to estimate how excipient properties in combination with process parameters influence the morphology of the engineered particles. A wide range of pharmaceutical application examples—low density particles, composite particles, microencapsulation, and glass stabilization—is discussed, with specific emphasis on the underlying particle formation mechanisms and design concepts. PMID:18040761

  1. A vision of the pharmaceutical industry.

    PubMed

    Muñio, S

    1998-01-01

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

  2. Technology evaluation: PRO-542, Progenics Pharmaceuticals inc.

    PubMed

    Mukhtar, M; Parveen, Z; Pomerantz, R J

    2000-12-01

    Progenics's rCD4-IgG2 (PRO-542) is a recombinant fusion protein, which has been developed using the company's Universal Antiviral Binding (UnAB) technology, and is in phase I/II clinical trials for the treatment of human immunodeficiency virus type I (HIV-1) infection [273391]. At the beginning of 1997, Progenics received a Phase II Small Business Innovation Research Program (SBIR) grant from the National Institute of Allergy and Infectious diseases (NIAID) to fund the development of PRO-542 [236048]. A further grant of $2.7 million was awarded in August 1998 for the clinical evaluation of PRO-542 and other anti-HIV therapies [294200]. Progenics is collaborating with the Aaron Diamond AIDS Research Center (ADARC) in New York and the Center for Disease Control and Prevention in Atlanta [178410]. In February 2000, Progenics and Genzyme Transgenics Corp signed an agreement to continue the development of a transgenic source of PRO-542. Genzyme will develop transgenic goats that produce PRO-542 in their milk in exchange for undisclosed fees and milestone payments. Genzyme will supply PRO-542 to Progenics for clinical trials with a possibility for eventual commercial supply [357291]. Following on from this, in October 2000, Progenics received an SBIR grant to fund a two-year project with Genzyme Transgenics into the development of cost-effective methods for the manufacture of PRO-542, by optimization of the production of the drug in the milk of transgenic dairy animals [385982]. In August 2000, Punk, Ziegel & Company predicted that Progenics Pharmaceuticals will become sustainably profitable in 2003 following the launch of PRO-542 and GMK (Progenics Pharmaceuticals) in 2002 [390063].

  3. [On teaching the chemistry of pharmaceutical auxiliary substances within the framework of pharmaceutical education in the Czech and Slovak Republics].

    PubMed

    Jan, Subert

    2011-02-01

    The paper emphasizes the need of the introduction of the subject Chemistry of Pharmaceutical Auxiliaries into the Pharmacy study programme at more colleges in the Czech and Slovak Republics. It also introduces and discusses some topics for possible extension of the content of the courses of the subject (the presented examples are taken form the field of analytical chemistry of pharmaceutical auxiliaries).

  4. 77 FR 21989 - Critical Infrastructure Private Sector Clearance Program Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-12

    ... SECURITY Critical Infrastructure Private Sector Clearance Program Request AGENCY: National Protection and... information provided. SUPPLEMENTARY INFORMATION: The Critical Infrastructure Private Sector Clearance Program (PSCP) sponsors clearances for private sector partners who are responsible for critical...

  5. Perceptions of Professionalism: A Case Study of Community College Baccalaureate Faculty

    ERIC Educational Resources Information Center

    Nasse, Jeffrey Peter

    2013-01-01

    This case study analyzed the perceptions of professionalism among an emerging and distinct occupational sector of community college faculty: community college faculty who teach in baccalaureate programs. The research was designed to address three questions as to the experiences of Community College Baccalaureate (CCB) faculty. First, what are the…

  6. Perceptions of Older Veterans with Visual Impairments Regarding Computer Access Training and Quality of Life

    ERIC Educational Resources Information Center

    DuBosque, Richard Stanborough

    2013-01-01

    The widespread integration of the computer into the mainstream of daily life presents a challenge to various sectors of society, and the incorporation of this technology into the realm of the older individual with visual impairments is a relatively uncharted field of study. This study was undertaken to acquire the perceptions of the impact of the…

  7. Multi-Sector Sustainability Browser (MSSB)

    EPA Pesticide Factsheets

    A browser which lets the user navigate through text and graphics and understand the interrelationship among four key sectors of a community crucial to sustainability: Land Use, Buildings and Infrastructure, Transportation, and Materials Management.

  8. Climate Leadership in the Financial Sector Webinar

    EPA Pesticide Factsheets

    Financial sector winners from the 2015 Climate Leadership Awards discuss best practices and challenges faced by their corporations based on their experience of attempting to reduce greenhouse gas emissions and address climate risk.

  9. Occupational health scenario of Indian informal sector

    PubMed Central

    NAG, Anjali; VYAS, Heer; NAG, Pranab

    2016-01-01

    Workers in the Indian informal sector are engaged with different occupations. These occupations involve varied work related hazards. These occupational hazards are a consequent risk to health. The study aimed to determine occupational health scenario in the Indian Informal sector. One thousand eleven hundred twenty two workers from five different occupations namely weaving (handloom and power loom), construction, transportation, tobacco processing and fish processing were assessed by interviewer administered health questionnaire. Workers suffered from musculo-skeletal complaints, respiratory health hazards, eye problems and skin related complaints. There was a high prevalence of self-reported occupational health problems in the selected sectors. The study finds that workers have occupational exposures to multiple hazards. The absence of protective guards aggrevate their health condition. The study attempts to draws an immediate attention on the existing health scenario of the Indian Informal sector. PMID:26903262

  10. Oil and Gas Extraction Sector (NAICS 211)

    EPA Pesticide Factsheets

    Environmental regulatory information for oil and gas extraction sectors, including oil and natural gas drilling. Includes information about NESHAPs for RICE and stationary combustion engines, and effluent guidelines for synthetic-based drilling fluids

  11. Automotive Sectors (NAICS 336, 4231, 8111)

    EPA Pesticide Factsheets

    Find regulatory, compliance, and enforcement information for environmental laws and regulations for the automotive sectors, which includes transportation equipment manufacturing, and establishments involved in repair and maintenance services for vehicles

  12. Ship and Boat Building Sector (NAICS 3336)

    EPA Pesticide Factsheets

    Find environmental regulatory and compliance information for the shipbuilding sector (NAICS 3336), including NESHAPs and air toxics regulations, nonroad engines and vehicles, managing used oil, and polluted runoff from marinas and boating areas.

  13. Market Report for the Industrial Sector, 2009

    SciTech Connect

    Sastri, Bhima; Brueske, Sabine; de los Reyes, Pamela; Jamison, Keith; Justiniano, Mauricio; Margolis, Nancy; Monfort, Joe; Raghunathan, Anand; Sabouni, Ridah

    2009-07-01

    This report provides an overview of trends in industrial-sector energy use. It focuses on some of the largest and most energy-intensive industrial subsectors and several emerging technologies that could transform key segments of industry.

  14. The Relationship among Training Policy, Knowledge Transfer, and Performance Improvement: A Study of Private Sector Organizations in the Kingdom of Saudi Arabia

    ERIC Educational Resources Information Center

    Shafloot, Fayez M.

    2012-01-01

    The purpose of this study was to explore human resource (HR) managers' perceptions of training practices (i.e., needs assessment, trainee preparation, training program review, accountability, management support, knowledge transfer, and performance improvement) in Saudi private sector organizations. The research questions were: (1) How do HR…

  15. Hidden drivers of low-dose pharmaceutical pollutant mixtures revealed by the novel GSA-QHTS screening method

    PubMed Central

    Rodea-Palomares, Ismael; Gonzalez-Pleiter, Miguel; Gonzalo, Soledad; Rosal, Roberto; Leganes, Francisco; Sabater, Sergi; Casellas, Maria; Muñoz-Carpena, Rafael; Fernández-Piñas, Francisca

    2016-01-01

    The ecological impacts of emerging pollutants such as pharmaceuticals are not well understood. The lack of experimental approaches for the identification of pollutant effects in realistic settings (that is, low doses, complex mixtures, and variable environmental conditions) supports the widespread perception that these effects are often unpredictable. To address this, we developed a novel screening method (GSA-QHTS) that couples the computational power of global sensitivity analysis (GSA) with the experimental efficiency of quantitative high-throughput screening (QHTS). We present a case study where GSA-QHTS allowed for the identification of the main pharmaceutical pollutants (and their interactions), driving biological effects of low-dose complex mixtures at the microbial population level. The QHTS experiments involved the integrated analysis of nearly 2700 observations from an array of 180 unique low-dose mixtures, representing the most complex and data-rich experimental mixture effect assessment of main pharmaceutical pollutants to date. An ecological scaling-up experiment confirmed that this subset of pollutants also affects typical freshwater microbial community assemblages. Contrary to our expectations and challenging established scientific opinion, the bioactivity of the mixtures was not predicted by the null mixture models, and the main drivers that were identified by GSA-QHTS were overlooked by the current effect assessment scheme. Our results suggest that current chemical effect assessment methods overlook a substantial number of ecologically dangerous chemical pollutants and introduce a new operational framework for their systematic identification. PMID:27617294

  16. Hidden drivers of low-dose pharmaceutical pollutant mixtures revealed by the novel GSA-QHTS screening method.

    PubMed

    Rodea-Palomares, Ismael; Gonzalez-Pleiter, Miguel; Gonzalo, Soledad; Rosal, Roberto; Leganes, Francisco; Sabater, Sergi; Casellas, Maria; Muñoz-Carpena, Rafael; Fernández-Piñas, Francisca

    2016-09-01

    The ecological impacts of emerging pollutants such as pharmaceuticals are not well understood. The lack of experimental approaches for the identification of pollutant effects in realistic settings (that is, low doses, complex mixtures, and variable environmental conditions) supports the widespread perception that these effects are often unpredictable. To address this, we developed a novel screening method (GSA-QHTS) that couples the computational power of global sensitivity analysis (GSA) with the experimental efficiency of quantitative high-throughput screening (QHTS). We present a case study where GSA-QHTS allowed for the identification of the main pharmaceutical pollutants (and their interactions), driving biological effects of low-dose complex mixtures at the microbial population level. The QHTS experiments involved the integrated analysis of nearly 2700 observations from an array of 180 unique low-dose mixtures, representing the most complex and data-rich experimental mixture effect assessment of main pharmaceutical pollutants to date. An ecological scaling-up experiment confirmed that this subset of pollutants also affects typical freshwater microbial community assemblages. Contrary to our expectations and challenging established scientific opinion, the bioactivity of the mixtures was not predicted by the null mixture models, and the main drivers that were identified by GSA-QHTS were overlooked by the current effect assessment scheme. Our results suggest that current chemical effect assessment methods overlook a substantial number of ecologically dangerous chemical pollutants and introduce a new operational framework for their systematic identification.

  17. Intervention studies on rational use of drugs in public and private sector in Nepal.

    PubMed

    Kafle, Kumud Kumar; Shrestha, Naveen; Karkee, Shiba Bahadur; Prasad, Radha Raman; Bhuju, Gajendra Bahadur; Das, Prabhakar Lal

    2005-06-01

    In developing countries, inappropriate, inefficient and ineffective use of pharmaceuticals have resulted into the poor health and medical cares for the community people. For improving the situation, various interventions have been tested and proved effective in different settings. In Nepal also, various strategies have been tested and found effective to improve the prescribing and dispensing practices. This paper has examined the process and results of different studies. The educational intervention, the training has not been effective in improving the prescribing practices but has limited effect on dispensing practices in the public sector. However, it becomes effective in improving prescribing practices if combined with a managerial intervention e.g. peer-group discussion. In private sector, training alone is effective in changing the drug recommendation practices of retailers. But none of interventions have been found to be effective in improving dispensing practices. After examining the effectiveness of different interventions, training combined with peer-group discussion is recommended for piloting in all Primary Health Care (PHC) outlets of a district to improve the prescribing practices. For improving the dispensing practices in both public and private sector, additional studies have to be carried out using different strategies.

  18. Building recycling rates through the informal sector.

    PubMed

    Wilson, David C; Araba, Adebisi O; Chinwah, Kaine; Cheeseman, Christopher R

    2009-02-01

    Many developing country cities aspire to modern waste management systems, which are associated with relatively high recycling rates of clean, source separated materials. Most already have informal sector recycling systems, which are driven solely by the revenues derived from selling recovered materials, even though they are saving the formal sector money by reducing waste quantities. There is clear potential for 'win-win' co-operation between the formal and informal sectors, as providing support to the informal sector, to build recycling rates and to address some of the social issues could reduce the overall costs of waste management for the formal sector. This paper shows that recycling rates already achieved by the informal sector can be quite high, typically in the range from 20% to 50%; often up to half of this is in the form of clean, source separated materials collected directly from households and businesses by itinerant waste buyers. Four country case studies provide a number of lessons on how this solid foundation could be used to build high recycling rates of clean materials.

  19. Building recycling rates through the informal sector

    SciTech Connect

    Wilson, David C.; Araba, Adebisi O.; Chinwah, Kaine; Cheeseman, Christopher R.

    2009-02-15

    Many developing country cities aspire to modern waste management systems, which are associated with relatively high recycling rates of clean, source separated materials. Most already have informal sector recycling systems, which are driven solely by the revenues derived from selling recovered materials, even though they are saving the formal sector money by reducing waste quantities. There is clear potential for 'win-win' co-operation between the formal and informal sectors, as providing support to the informal sector, to build recycling rates and to address some of the social issues could reduce the overall costs of waste management for the formal sector. This paper shows that recycling rates already achieved by the informal sector can be quite high, typically in the range from 20% to 50%; often up to half of this is in the form of clean, source separated materials collected directly from households and businesses by itinerant waste buyers. Four country case studies provide a number of lessons on how this solid foundation could be used to build high recycling rates of clean materials.

  20. Cyclical absenteeism among private sector, public sector and self-employed workers.

    PubMed

    Pfeifer, Christian

    2013-03-01

    This research note analyzes differences in the number of absent working days and doctor visits and in their cyclicality between private sector, public sector and self-employed workers. For this purpose, I used large-scale German survey data for the years 1995 to 2007 to estimate random effects negative binomial (count data) models. The main findings are as follows. (i) Public sector workers have on average more absent working days than private sector and self-employed workers. Self-employed workers have fewer absent working days and doctor visits than dependent employed workers. (ii) The regional unemployment rate is on average negatively correlated with the number of absent working days among private and public sector workers as well as among self-employed men. The correlations between regional unemployment rate and doctor visits are only significantly negative among private sector workers.