WorldWideScience

Sample records for global specialty biopharmaceutical

  1. Biopharmaceutical industry-sponsored global clinical trials in emerging countries.

    Science.gov (United States)

    Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira

    2010-01-01

    To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (pattractiveness for biopharmaceutical industry-sponsored clinical trials.

  2. Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators

    Directory of Open Access Journals (Sweden)

    Rezaie Rahim

    2012-06-01

    Full Text Available Abstract Biopharmaceutical innovation has had a profound health and economic impact globally. Developed countries have traditionally been the source of most innovations as well as the destination for the resulting economic and health benefits. As a result, most prior research on this sector has focused on developed countries. This paper seeks to fill the gap in research on emerging markets by analyzing factors that influence innovative activity in the indigenous biopharmaceutical sectors of China, India, Brazil, and South Africa. Using qualitative research methodologies, this paper a shows how biopharmaceutical innovation is taking place within the entrepreneurial sectors of these emerging markets, b identifies common challenges that indigenous entrepreneurs face, c highlights the key role played by the state, and d reveals that the transition to innovation by companies in the emerging markets is characterized by increased global integration. It suggests that biopharmaceutical innovators in emerging markets are capitalizing on opportunities to participate in the drug development value chain and thus developing capabilities and relationships for competing globally both with and against established companies headquartered in developed countries.

  3. Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators.

    Science.gov (United States)

    Rezaie, Rahim; McGahan, Anita M; Frew, Sarah E; Daar, Abdallah S; Singer, Peter A

    2012-06-06

    Biopharmaceutical innovation has had a profound health and economic impact globally. Developed countries have traditionally been the source of most innovations as well as the destination for the resulting economic and health benefits. As a result, most prior research on this sector has focused on developed countries. This paper seeks to fill the gap in research on emerging markets by analyzing factors that influence innovative activity in the indigenous biopharmaceutical sectors of China, India, Brazil, and South Africa. Using qualitative research methodologies, this paper a) shows how biopharmaceutical innovation is taking place within the entrepreneurial sectors of these emerging markets, b) identifies common challenges that indigenous entrepreneurs face, c) highlights the key role played by the state, and d) reveals that the transition to innovation by companies in the emerging markets is characterized by increased global integration. It suggests that biopharmaceutical innovators in emerging markets are capitalizing on opportunities to participate in the drug development value chain and thus developing capabilities and relationships for competing globally both with and against established companies headquartered in developed countries.

  4. The market of biopharmaceutical medicines: A snapshot of a diverse industrial landscape

    NARCIS (Netherlands)

    Moorkens, E. (Evelien); Meuwissen, N. (Nicolas); Huys, I. (Isabelle); P.J. Declerck (Paul); A.G. Vulto (Arnold); S. Simoens (Steven)

    2017-01-01

    textabstractBackground: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market. Objectives: This study aims to identify

  5. Next Generation Biopharmaceuticals: Product Development.

    Science.gov (United States)

    Mathaes, Roman; Mahler, Hanns-Christian

    2018-04-11

    Therapeutic proteins show a rapid market growth. The relatively young biotech industry already represents 20 % of the total global pharma market. The biotech industry environment has traditionally been fast-pasted and intellectually stimulated. Nowadays the top ten best selling drugs are dominated by monoclonal antibodies (mABs).Despite mABs being the biggest medical breakthrough in the last 25 years, technical innovation does not stand still.The goal remains to preserve the benefits of a conventional mAB (serum half-life and specificity) whilst further improving efficacy and safety and to open new and better avenues for treating patients, e.g., improving the potency of molecules, target binding, tissue penetration, tailored pharmacokinetics, and reduced adverse effects or immunogenicity.The next generation of biopharmaceuticals can pose specific chemistry, manufacturing, and control (CMC) challenges. In contrast to conventional proteins, next-generation biopharmaceuticals often require lyophilization of the final drug product to ensure storage stability over shelf-life time. In addition, next-generation biopharmaceuticals require analytical methods that cover different ways of possible degradation patterns and pathways, and product development is a long way from being straight forward. The element of "prior knowledge" does not exist equally for most novel formats compared to antibodies, and thus the assessment of critical quality attributes (CQAs) and the definition of CQA assessment criteria and specifications is difficult, especially in early-stage development.

  6. Mammalian cell culture capacity for biopharmaceutical manufacturing.

    Science.gov (United States)

    Ecker, Dawn M; Ransohoff, Thomas C

    2014-01-01

    : With worldwide sales of biopharmaceuticals increasing each year and continuing growth on the horizon, the manufacture of mammalian biopharmaceuticals has become a major global enterprise. We describe the current and future industry wide supply of manufacturing capacity with regard to capacity type, distribution, and geographic location. Bioreactor capacity and the use of single-use products for biomanufacturing are also profiled. An analysis of the use of this capacity is performed, including a discussion of current trends that will influence capacity growth, availability, and utilization in the coming years.

  7. The state of biopharmaceutical manufacturing.

    Science.gov (United States)

    Molowa, David T; Mazanet, Rosemary

    2003-01-01

    The manufacturing of protein-based biopharmaceuticals is done in bacterial or mammalian cell cultures. While bacterial cultures are inexpensive, dependable, and approved by regulatory authorities, many complex proteins cannot be manufactured this way. Complex proteins must be manufactured in mammalian cell cultures to produce active products. Mammalian cell culture capacity is limited and has slowed the delivery of necessary biopharmaceutical products to patients. The nature of the production capacity problem and future outlook are critically examined.

  8. Biopharmaceuticals as Challenges to the Regulatory System

    NARCIS (Netherlands)

    Ebbers, H.C.

    2012-01-01

    Biopharmaceuticals differ from small molecules in terms of structure and pharmacology. Furthermore, they are also prescribed for different patient populations. The protein nature of biopharmaceuticals makes them especially prone for immunological reactions and their safety profile may be affected by

  9. Risk Management in Biopharmaceutical Supply Chains

    OpenAIRE

    Ma, Yao

    2011-01-01

    Biopharmaceutical supply chains present considerable complexity issue for the formulation of optimal plans due to significant uncertainty in the supply chain. The primary goal of biopharmaceutical supply chain planning is to provide reliable supply to patients while coping with various supply chain risks. In chapter 1 first I discuss the key elements and basic characteristics of the biopharmaceutical supply chain . Then I present the major challenges in biopharmaceutical supply chain planning...

  10. The Market of Biopharmaceutical Medicines: A Snapshot of a Diverse Industrial Landscape

    Directory of Open Access Journals (Sweden)

    Evelien Moorkens

    2017-06-01

    Full Text Available Background: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market.Objectives: This study aims to identify and document which investment and development strategies are adopted by industrial players in the global biopharmaceutical market.Methods: A descriptive analysis was undertaken of the investment and development strategies of the top 25 pharmaceutical companies according to 2015 worldwide prescription drug sales. Strategies were documented by collecting data on manufacturing plans, development programs, acquisition and collaboration agreements, the portfolio and pipeline of biosimilar, originator and next-generation biopharmaceutical products. Data were extracted from publicly available sources.Results: Various investment and development strategies can be identified in the global biopharmaceutical market: (a development of originator biopharmaceuticals, (b investment in biotechnology, (c development of next-generation biopharmaceuticals, (d development of biosimilars, (e investment in emerging countries, and (f collaboration between companies. In the top 25 pharmaceutical companies almost every company invests in originator biopharmaceuticals and in biotechnology in general, but only half of them develops next-generation biopharmaceuticals. Furthermore, only half of them invest in development of biosimilars. The companies' biosimilar pipeline is mainly focused on development of biosimilar monoclonal antibodies and to some extent on biosimilar insulins. A common strategy is collaboration between companies and investment in emerging countries.Conclusions: A snapshot of investment and development strategies used by industrial players in the global biopharmaceutical market shows that all top 25 pharmaceutical companies are engaged in the biopharmaceutical market and

  11. Bioethical issues in the development of biopharmaceuticals

    Directory of Open Access Journals (Sweden)

    Todorović Zoran

    2012-01-01

    Full Text Available Development of biopharmaceuticals is a challenging issue in bioethics. Unlike conventional, small molecular weight drugs, biopharmaceuticals are proteins derived from DNA technology and hybrid techniques with complex three dimensional structures. Immunogenicity of biopharmaceuticals should always be tested in clinical settings due to low predictive value of preclinical animal models. However, non-human primates (NHP and transgenic mice could be used to address certain aspects of immunogenicity. Substantial efforts have been made to reduce NHP use in biopharmaceutical drug development, e.g. study design improvements and changes in regulatory policy. In addition, several expert groups are active in this field (e.g. NC3Rs, BioSafe, and Biopharmaceutical Technical Group. Despite that, there is an increasing trend of use of NHP in preclinical safety testing of biopharmaceuticals, especially regarding monoclonal antibodies. Other potential bioethical issues related biopharmaceutical drug development are their cost/effectiveness ratio, clinical safety assessment, production of biosimilars, and comparison of their efficacy with placebo in countries without intention to market. Identification of the human genome has opened many new bioethical issues. Development of biopharmaceuticals is an important bioethical issue for several reasons. It connects all aspects of contemporary bioethics: bio­medicine (e.g. clinical trials in vulnerable subjects, animal welfare and the most recent ad­vances in biotechnology. In particular, biopharmaceutical drug development is a challenging issue regarding treatment of rare diseases.

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

    Science.gov (United States)

    Yan, Gujun

    2014-07-01

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

  13. Biosurfactants in cosmetics and biopharmaceuticals.

    Science.gov (United States)

    Varvaresou, A; Iakovou, K

    2015-09-01

    Biosurfactants are surface-active biomolecules that are produced by various micro-organisms. They show unique properties i.e. lower toxicity, higher biodegradability and environmental compatibility compared to their chemical counterparts. Glycolipids and lipopeptides have prompted application in biotechnology and cosmetics due to their multi-functional profile i.e. detergency, emulsifying, foaming and skin hydrating properties. Additionally, some of them can be served as antimicrobials. In this study the current status of research and development on rhamnolipids, sophorolipids, mannosyloerythritol lipids, trehalipids, xylolipids and lipopeptides particularly their commercial application in cosmetics and biopharmaceuticals, is described. © 2015 The Society for Applied Microbiology.

  14. Small and Medium Enterprises and Biopharmaceutical Innovations ...

    African Journals Online (AJOL)

    Small and Medium Enterprises and Biopharmaceutical Innovations in Africa: ... through biotechnological processes with links to biological sources especially those of live ... There are more than 500 biopharmaceutical products that have been ... By Country · List All Titles · Free To Read Titles This Journal is Open Access.

  15. Continuous downstream processing of biopharmaceuticals.

    Science.gov (United States)

    Jungbauer, Alois

    2013-08-01

    Continuous manufacturing has been applied in many different industries but has been pursued reluctantly in biotechnology where the batchwise process is still the standard. A shift to continuous operation can improve productivity of a process and substantially reduce the footprint. Continuous operation also allows robust purification of labile biomolecules. A full set of unit operations is available to design continuous downstream processing of biopharmaceuticals. Chromatography, the central unit operation, is most advanced in respect to continuous operation. Here, the problem of 'batch' definition has been solved. This has also paved the way for implementation of continuous downstream processing from a regulatory viewpoint. Economic pressure, flexibility, and parametric release considerations will be the driving force to implement continuous manufacturing strategies in future. Copyright © 2013 Elsevier Ltd. All rights reserved.

  16. Small and Medium Enterprises and Biopharmaceutical Innovations ...

    African Journals Online (AJOL)

    Erah

    Benin City, 300001 Nigeria. All rights ... are challenges facing African Small and Medium Enterprises (SMEs) in biopharmaceutical industry, the ... Network for Drug and Diagnostics recognizes .... functionality is in place, integration into the.

  17. Process analytical technology (PAT) for biopharmaceuticals

    DEFF Research Database (Denmark)

    Glassey, Jarka; Gernaey, Krist; Clemens, Christoph

    2011-01-01

    Process analytical technology (PAT), the regulatory initiative for building in quality to pharmaceutical manufacturing, has a great potential for improving biopharmaceutical production. The recommended analytical tools for building in quality, multivariate data analysis, mechanistic modeling, novel...

  18. The Research on International Development Path of China’s Marine Biopharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Xiu-Mei Fu

    2018-02-01

    Full Text Available Under the backdrop of the Maritime Silk Road Initiative, the study on the international development of China’s marine biopharmaceutical industry based on factor allocation is of great practical significance for industrial sustainability and building the industry into a leading international player in the global market. In this paper, we first identify the leading factors that influence the development of the marine biopharmaceutical industry, namely, resources, technologies, talents, investments and policies. Furthermore, the hierarchical structure model of these factors was established and analyzed using the analytic hierarchy process (AHP. The importance ranking of these constraints was identified, as follows: technologies > talents > resources > policies > investments. Then, based on the theory of comparative advantage and game theory, we analyzed the necessity of China’s marine biopharmaceutical industry going global, that is, international cooperation may lay a solid foundation for the win-win outcome of this industry in countries along the Maritime Silk Road. According to the status quo of China’s marine biopharmaceutical industry, based on these findings, an international factor–allocation cooperation path was designed, and the path chart of the international development of the marine biopharmaceutical industry was drawn. Finally, methods for the development of China’s marine biopharmaceutical industry were proposed, which covers efforts to protect marine resources, promote R&D for core technologies, establish a strong talent pool, encourage more investments, provide policy support and promote worldwide cooperation. It is the first report to investigate the path of the sustainable exploitation of the marine biopharmaceutical industry from the perspective of factor allocation amidst the backdrop of the Maritime Silk Road Initiative.

  19. Bioanalytical LC-MS/MS of protein-based biopharmaceuticals

    NARCIS (Netherlands)

    Broek, I. van den; Niessen, W.M.A.; Dongen, W.D. van

    2013-01-01

    Biotechnology increasingly delivers highly promising protein-based biopharmaceutical candidates to the drug development funnel. For successful biopharmaceutical drug development, reliable bioanalytical methods enabling quantification of drugs in biological fluids (plasma, urine, tissue, etc.) are

  20. Cell Engineering and Molecular Pharming for Biopharmaceuticals

    Science.gov (United States)

    Abdullah, M.A; Rahmah, Anisa ur; Sinskey, A.J; Rha, C.K

    2008-01-01

    Biopharmaceuticals are often produced by recombinant E. coli or mammalian cell lines. This is usually achieved by the introduction of a gene or cDNA coding for the protein of interest into a well-characterized strain of producer cells. Naturally, each recombinant production system has its own unique advantages and disadvantages. This paper examines the current practices, developments, and future trends in the production of biopharmaceuticals. Platform technologies for rapid screening and analyses of biosystems are reviewed. Strategies to improve productivity via metabolic and integrated engineering are also highlighted. PMID:19662143

  1. Traceability of biopharmaceuticals in spontaneous reporting systems

    DEFF Research Database (Denmark)

    Vermeer, Niels S; Straus, Sabine M J M; Mantel-Teeuwisse, Aukje K

    2013-01-01

    the period 2004-2010, including ADR reports from two major SRSs: the FDA Adverse Event Reporting System (FAERS) in the US and EudraVigilance (EV) in the EU. MAIN OUTCOME MEASURES: The availability of batch numbers was determined for biopharmaceuticals, and compared with small molecule drugs...

  2. Biopharmaceutical innovation and industrial developments in South Korea, Singapore and Taiwan.

    Science.gov (United States)

    Hsieh, Chee-Ruey; Löfgren, Hans

    2009-05-01

    South Korea, Singapore and Taiwan are well known as export-oriented developmental states which for decades employed industrial policy to target particular industries for government support. In the past fifteen years, these three countries all identified the biopharmaceutical industry as a strategic sector. This article explores, through economic analysis, the rationale for this decision and the strategies chosen for linking into the global bio-economy with the objective of catching up in biopharmaceuticals. The paper identifies three comparative advantages enjoyed by these countries in the biopharma sector: (1) public investments in basic research; (2) private investments in phase 1 clinical trials; and (3) a potentially significant contract research industry managing latter-stage clinical trials. Governments employ a range of industrial policies, consistent with these comparative advantages, to promote the biopharmaceutical industry, including public investment in biomedical hubs, research funding and research and development (R&D) tax credits. We argue that the most important feature of the biopharmaceutical industry in these countries is the dominant role of the public sector. That these countries have made progress in innovative capabilities is illustrated by input measures such as R&D expenditure as share of gross domestic product, number of patents granted and clinical trials, and volume of foreign direct investment. In contrast, output indicators such as approval of new chemical entities suggest that the process of catching up has only just commenced. Pharmaceutical innovation is at the stage of mainly generating inputs to integrated processes controlled by the globally incumbent firms.

  3. High-Throughput Process Development for Biopharmaceuticals.

    Science.gov (United States)

    Shukla, Abhinav A; Rameez, Shahid; Wolfe, Leslie S; Oien, Nathan

    2017-11-14

    The ability to conduct multiple experiments in parallel significantly reduces the time that it takes to develop a manufacturing process for a biopharmaceutical. This is particularly significant before clinical entry, because process development and manufacturing are on the "critical path" for a drug candidate to enter clinical development. High-throughput process development (HTPD) methodologies can be similarly impactful during late-stage development, both for developing the final commercial process as well as for process characterization and scale-down validation activities that form a key component of the licensure filing package. This review examines the current state of the art for HTPD methodologies as they apply to cell culture, downstream purification, and analytical techniques. In addition, we provide a vision of how HTPD activities across all of these spaces can integrate to create a rapid process development engine that can accelerate biopharmaceutical drug development. Graphical Abstract.

  4. Plant-made vaccine antigens and biopharmaceuticals.

    Science.gov (United States)

    Daniell, Henry; Singh, Nameirakpam D; Mason, Hugh; Streatfield, Stephen J

    2009-12-01

    Plant cells are ideal bioreactors for the production and oral delivery of vaccines and biopharmaceuticals, eliminating the need for expensive fermentation, purification, cold storage, transportation and sterile delivery. Plant-made vaccines have been developed for two decades but none has advanced beyond Phase I. However, two plant-made biopharmaceuticals are now advancing through Phase II and Phase III human clinical trials. In this review, we evaluate the advantages and disadvantages of different plant expression systems (stable nuclear and chloroplast or transient viral) and their current limitations or challenges. We provide suggestions for advancing this valuable concept for clinical applications and conclude that greater research emphasis is needed on large-scale production, purification, functional characterization, oral delivery and preclinical evaluation.

  5. Health economics of market access for biopharmaceuticals and biosimilars.

    Science.gov (United States)

    Simoens, Steven

    2009-09-01

    This article discusses health economic challenges of research and development, registration, pricing and reimbursement of biopharmaceuticals and biosimilars. A literature search was carried out of PubMed, Centre for Reviews and Dissemination databases, Cochrane Database of Systematic Reviews and EconLit up to March 2009. The development process of biopharmaceuticals is risky, lengthy, complex and expensive. Registration is complicated by the inherent variation between biopharmaceuticals. Also, as biopharmaceuticals are likely to be efficacious in a subgroup of the patient population, there is a need to select the most responsive target population and to identify biomarkers. To inform pricing and reimbursement decisions, the development process needs to collect comparative data to calculate the incremental cost effectiveness and budget impact of biopharmaceuticals. There is a role for innovative mechanisms such as risk-sharing arrangements to reimburse biopharmaceuticals. Given that biosimilars are similar, but not identical to the reference biopharmaceutical, the development process needs to generate clinical trial data in order to gain marketing authorisation. From a health economic perspective, the question arises whether inherent differences between biopharmaceuticals and biosimilars produce differences in safety, effectiveness and costs: to date, this question is unresolved. The early inclusion of health economics in the process of developing biopharmaceuticals and biosimilars is imperative with a view to demonstrating their relative (cost) effectiveness and informing registration, pricing and reimbursement decisions.

  6. Investigating investment in biopharmaceutical R&D

    Science.gov (United States)

    Carter, Percy H.; Berndt, Ernst R.; DiMasi, Joseph A.; Trusheim, Mark

    2016-01-01

    Recent studies have highlighted a reduction in projected financial returns associated with biopharmaceutical R&D, owing to decreased productivity, increases in costs and flattening revenue per new drug, prompting calls for dramatic revisions to R&D models. On the basis of previous financial modelling, the simplest hypothesis would be that new investment in such R&D should be minimal and focused on biologics in preference to small molecules, as the internal rate of return on investment for biologics projects has been reported to be higher. PMID:27616295

  7. Exploring the potential of Saccharomyces cerevisiae for biopharmaceutical protein production

    DEFF Research Database (Denmark)

    Wang, Guokun; Huang, Mingtao; Nielsen, Jens

    2017-01-01

    Production of recombinant proteins by yeast plays a vital role in the biopharmaceutical industry. It is therefore desirable to develop yeast platform strains for over-production of various biopharmaceutical proteins, but this requires fundamental knowledge of the cellular machinery, especially th...

  8. Delivery and Immunogenicity of Biopharmaceuticals for Vaccination or Therapy

    NARCIS (Netherlands)

    de Groot, A.M.

    2017-01-01

    Biopharmaceuticals (or biologicals) are a new class of drugs produced by the biotechnology field and offer many advantages compared to classical small molecule synthetic drugs. Biopharmaceuticals (BP) are from biological origin and may consist of proteins or peptides, nucleic acids such as RNA and

  9. Glycan characterization of biopharmaceuticals: Updates and perspectives

    Energy Technology Data Exchange (ETDEWEB)

    Planinc, Ana [Analytical Platform of the Faculty of Pharmacy and Laboratory of Pharmaceutical Chemistry, Faculty of Pharmacy, Universite Libre de Bruxelles (ULB), Brussels (Belgium); Bones, Jonathan [Characterisation and Comparability Laboratory, NIBRT – The National Institute for Bioprocessing Research and Training, Foster Avenue, Mount Merrion, Blackrock, Co. Dublin (Ireland); Dejaegher, Bieke [Laboratory of Instrumental Analysis and Bioelectrochemistry, Faculty of Pharmacy, Université Libre de Bruxelles (ULB), Boulevard du Triomphe, B-1050 Brussels (Belgium); Department of Analytical Chemistry and Pharmaceutical Technology (FABI), Center for Pharmaceutical Research (CePhaR), Faculty of Medicines and Pharmacy, Vrije Universiteit Brussel - VUB, Laarbeeklaan 103, B-1090 Brussels (Belgium); Van Antwerpen, Pierre [Analytical Platform of the Faculty of Pharmacy and Laboratory of Pharmaceutical Chemistry, Faculty of Pharmacy, Universite Libre de Bruxelles (ULB), Brussels (Belgium); Delporte, Cédric, E-mail: cedric.delporte@ulb.ac.be [Analytical Platform of the Faculty of Pharmacy and Laboratory of Pharmaceutical Chemistry, Faculty of Pharmacy, Universite Libre de Bruxelles (ULB), Brussels (Belgium)

    2016-05-19

    Therapeutic proteins are rapidly becoming the most promising class of pharmaceuticals on the market due to their successful treatment of a vast array of serious diseases, such as cancers and immune disorders. Therapeutic proteins are produced using recombinant DNA technology. More than 60% of therapeutic proteins are posttranslationally modified following biosynthesis by the addition of N- or O-linked glycans. Glycosylation is the most common posttranslational modifications of proteins. However, it is also the most demanding and complex posttranslational modification from the analytical point of view. Moreover, research has shown that glycosylation significantly impacts stability, half-life, mechanism of action and safety of a therapeutic protein. Considering the exponential growth of biotherapeutics, this present review of the literature (2009–2015) focuses on the characterization of protein glycosylation, which has witnessed an improvement in methodology. Furthermore, it discusses current issues in the fields of production and characterization of therapeutic proteins. This review also highlights the problem of non-standard requirements for the approval of biosimilars with regard to their glycosylation and discusses recent developments and perspectives for improved glycan characterization. - Highlights: • Biopharmaceuticals have emerged as the new class of blockbuster drugs in the pharmaceutical industry. • More than 60% of the approved biopharmaceuticals are glycosylated. • Glycosylation has an effect on the efficacy and the safety of therapeutic glycoproteins. • N-glycosylation characterization of therapeutic glycoproteins is a regulatory requirement. • Biosimilar releases are increasing and demonstration of comparability poses challenges for N-glycosylation characterization.

  10. Glycan characterization of biopharmaceuticals: Updates and perspectives

    International Nuclear Information System (INIS)

    Planinc, Ana; Bones, Jonathan; Dejaegher, Bieke; Van Antwerpen, Pierre; Delporte, Cédric

    2016-01-01

    Therapeutic proteins are rapidly becoming the most promising class of pharmaceuticals on the market due to their successful treatment of a vast array of serious diseases, such as cancers and immune disorders. Therapeutic proteins are produced using recombinant DNA technology. More than 60% of therapeutic proteins are posttranslationally modified following biosynthesis by the addition of N- or O-linked glycans. Glycosylation is the most common posttranslational modifications of proteins. However, it is also the most demanding and complex posttranslational modification from the analytical point of view. Moreover, research has shown that glycosylation significantly impacts stability, half-life, mechanism of action and safety of a therapeutic protein. Considering the exponential growth of biotherapeutics, this present review of the literature (2009–2015) focuses on the characterization of protein glycosylation, which has witnessed an improvement in methodology. Furthermore, it discusses current issues in the fields of production and characterization of therapeutic proteins. This review also highlights the problem of non-standard requirements for the approval of biosimilars with regard to their glycosylation and discusses recent developments and perspectives for improved glycan characterization. - Highlights: • Biopharmaceuticals have emerged as the new class of blockbuster drugs in the pharmaceutical industry. • More than 60% of the approved biopharmaceuticals are glycosylated. • Glycosylation has an effect on the efficacy and the safety of therapeutic glycoproteins. • N-glycosylation characterization of therapeutic glycoproteins is a regulatory requirement. • Biosimilar releases are increasing and demonstration of comparability poses challenges for N-glycosylation characterization.

  11. Nursing specialty and burnout.

    Science.gov (United States)

    Browning, Laura; Ryan, Carey S; Thomas, Scott; Greenberg, Martin; Rolniak, Susan

    2007-03-01

    We examined the relationship between perceived control and burnout among three nursing specialties: nurse practitioners, nurse managers, and emergency nurses. Survey data were collected from 228 nurses from 30 states. Findings indicated that emergency nurses had the least control and the highest burnout, whereas nurse practitioners had the most control and the least burnout. Mediational analyses showed that expected control, hostility, and stressor frequency explained differences between specialties in burnout. The implications of these findings for interventions that reduce burnout and promote nursing retention are discussed.

  12. Interplay of biopharmaceutics, biopharmaceutics drug disposition and salivary excretion classification systems

    Science.gov (United States)

    Idkaidek, Nasir M.

    2013-01-01

    The aim of this commentary is to investigate the interplay of Biopharmaceutics Classification System (BCS), Biopharmaceutics Drug Disposition Classification System (BDDCS) and Salivary Excretion Classification System (SECS). BCS first classified drugs based on permeability and solubility for the purpose of predicting oral drug absorption. Then BDDCS linked permeability with hepatic metabolism and classified drugs based on metabolism and solubility for the purpose of predicting oral drug disposition. On the other hand, SECS classified drugs based on permeability and protein binding for the purpose of predicting the salivary excretion of drugs. The role of metabolism, rather than permeability, on salivary excretion is investigated and the results are not in agreement with BDDCS. Conclusion The proposed Salivary Excretion Classification System (SECS) can be used as a guide for drug salivary excretion based on permeability (not metabolism) and protein binding. PMID:24493977

  13. Second International Conference on Accelerating Biopharmaceutical Development

    Science.gov (United States)

    2009-01-01

    The Second International Conference on Accelerating Biopharmaceutical Development was held in Coronado, California. The meeting was organized by the Society for Biological Engineering (SBE) and the American Institute of Chemical Engineers (AIChE); SBE is a technological community of the AIChE. Bob Adamson (Wyeth) and Chuck Goochee (Centocor) were co-chairs of the event, which had the theme “Delivering cost-effective, robust processes and methods quickly and efficiently.” The first day focused on emerging disruptive technologies and cutting-edge analytical techniques. Day two featured presentations on accelerated cell culture process development, critical quality attributes, specifications and comparability, and high throughput protein formulation development. The final day was dedicated to discussion of technology options and new analysis methods provided by emerging disruptive technologies; functional interaction, integration and synergy in platform development; and rapid and economic purification process development. PMID:20065637

  14. Separation science is the key to successful biopharmaceuticals.

    Science.gov (United States)

    Guiochon, Georges; Beaver, Lois Ann

    2011-12-09

    The impact of economic change, advances in science, therapy and production processes resulted in considerable growth in the area of biopharmaceuticals. Progress in selection of microorganisms and improvements in cell culture and bioreactors is evidenced by increased yields of the desired products in the complex fermentation mixture. At this stage the downstream process of extraction and purification of the desired biopharmaceutical requires considerable attention in the design and operation of the units used for preparative chromatography. Understanding of the process, optimization of column design and experimental conditions have become critical to the biopharmaceutical industry in order to minimize production costs while satisfying new regulatory requirements. Optimization of the purification of biopharmaceuticals by preparative liquid chromatography including an examination of column preparation and bed properties is the focus of this manuscript. Copyright © 2011 Elsevier B.V. All rights reserved.

  15. Capillary electrophoresis in the N-glycosylation analysis of biopharmaceuticals

    Czech Academy of Sciences Publication Activity Database

    Guttman, András

    2013-01-01

    Roč. 48, JUL-AUG (2013), s. 132-143 ISSN 0165-9936 Institutional support: RVO:68081715 Keywords : automated workflow * biopharmaceuticals * capillary electrophoresis Subject RIV: CB - Analytical Chemistry, Separation Impact factor: 6.612, year: 2013

  16. Follow-on biologics: competition in the biopharmaceutical marketplace.

    Science.gov (United States)

    Devine, Joshua W; Cline, Richard R; Farley, Joel F

    2006-01-01

    To describe the implications of a follow-on biologic approval process with focus on current stakeholders, implications of the status quo, and recommendations for future policy. A search using Medline, International Pharmaceutical Abstracts, Med Ad News, F-D-C Reports/Pink Sheets, and Google index directories was conducted with terms such as biologic, biopharmaceutical, generic, and follow-on. Articles pertaining to the follow-on biologic debate. By the authors. Over the past decade, the biopharmaceutical market has experienced substantial growth in the number of product approvals and sales. In contrast with prescription medications, biologic agents currently lack an abbreviated regulatory approval process. Evidence from the Drug Price Competition and Patent Term Restoration Act of 1984 suggests that reducing barriers to generic competition in the pharmaceutical market successfully increases generic market penetration and reduces overall prices to consumers. Although scientific and regulatory dissimilarities between biopharmaceuticals and other medications exist, a follow-on biologic approval process has the potential to play an important role in containing growth in pharmaceutical spending. In addition to biopharmaceutical and generic biopharmaceutical manufacturers, stakeholders with a vested interest in this debate include individual consumers who continue to bear the burden of spending increases in the pharmaceutical market. The debate over a follow-on process likely will be difficult as parties seek a balance between incentives for biopharmaceutical innovation, consumer safety, and affordability of existing biologic products.

  17. Biopharmaceutical potentials of Prosopis spp. (Mimosaceae, Leguminosa

    Directory of Open Access Journals (Sweden)

    Santhaseelan Henciya

    2017-01-01

    Full Text Available Prosopis is a commercially important plant genus, which has been used since ancient times, particularly for medicinal purposes. Traditionally, Paste, gum, and smoke from leaves and pods are applied for anticancer, antidiabetic, anti-inflammatory, and antimicrobial purposes. Components of Prosopis such as flavonoids, tannins, alkaloids, quinones, or phenolic compounds demonstrate potentials in various biofunctions, such as analgesic, anthelmintic, antibiotic, antiemetic, microbial antioxidant, antimalarial, antiprotozoal, antipustule, and antiulcer activities; enhancement of H+, K+, ATPases; oral disinfection; and probiotic and nutritional effects; as well as in other biopharmaceutical applications, such as binding abilities for tablet production. The compound juliflorine provides a cure in Alzheimer disease by inhibiting acetylcholine esterase at cholinergic brain synapses. Some indirect medicinal applications of Prosopis spp. are indicated, including antimosquito larvicidal activity, chemical synthesis by associated fungal or bacterial symbionts, cyanobacterial degradation products, “mesquite” honey and pollens with high antioxidant activity, etc. This review will reveal the origins, distribution, folk uses, chemical components, biological functions, and applications of different representatives of Prosopis.

  18. Production of biopharmaceutical proteins by yeast: Advances through metabolic engineering

    DEFF Research Database (Denmark)

    Nielsen, Jens

    2013-01-01

    Production of recombinant proteins for use as pharmaceuticals, so-called biopharmaceuticals, is a multi-billion dollar industry. Many different cell factories are used for the production of biopharmaceuticals, but the yeast Saccharomyces cerevisiae is an important cell factory as it is used for p...... production. The involvement of directed metabolic engineering through the integration of tools from genetic engineering, systems biology and mathematical modeling, is also discussed....... by yeast are human serum albumin, hepatitis vaccines and virus like particles used for vaccination against human papillomavirus. Here is given a brief overview of biopharmaceutical production by yeast and it is discussed how the secretory pathway can be engineered to ensure more efficient protein...

  19. Animal models for evaluation of oral delivery of biopharmaceuticals

    DEFF Research Database (Denmark)

    Harloff-Helleberg, Stine; Nielsen, Line Hagner; Nielsen, Hanne Mørck

    2017-01-01

    of systems for oral delivery of biopharmaceuticals may result in new treatment modalities to increase the patient compliance and reduce product cost. In the preclinical development phase, use of experimental animal models is essential for evaluation of new formulation designs. In general, the limited oral...... bioavailability of biopharmaceuticals, of just a few percent, is expected, and therefore, the animal models and the experimental settings must be chosen with utmost care. More knowledge and focus on this topic is highly needed, despite experience from the numerous studies evaluating animal models for oral drug...... delivery of small molecule drugs. This review highlights and discusses pros and cons of the most currently used animal models and settings. Additionally, it also looks into the influence of anesthetics and sampling methods for evaluation of drug delivery systems for oral delivery of biopharmaceuticals...

  20. Biopharmaceutical production: Applications of surface plasmon resonance biosensors.

    Science.gov (United States)

    Thillaivinayagalingam, Pranavan; Gommeaux, Julien; McLoughlin, Michael; Collins, David; Newcombe, Anthony R

    2010-01-15

    Surface plasmon resonance (SPR) permits the quantitative analysis of therapeutic antibody concentrations and impurities including bacteria, Protein A, Protein G and small molecule ligands leached from chromatography media. The use of surface plasmon resonance has gained popularity within the biopharmaceutical industry due to the automated, label free, real time interaction that may be exploited when using this method. The application areas to assess protein interactions and develop analytical methods for biopharmaceutical downstream process development, quality control, and in-process monitoring are reviewed. 2009 Elsevier B.V. All rights reserved.

  1. Psychiatric specialty training in Greece.

    Science.gov (United States)

    Margariti, M; Kontaxakis, V; Ploumpidis, D

    2017-01-01

    The reform and development of psychiatric services require, in addition to financial resources, reserves in specialized human resources. The role of psychiatrists in this process, and at reducing the consequences of mental morbidity is evident. Psychiatrists are required to play a multifaceted role as clinicians, as experts in multidisciplinary team environments and as advisors in the recognition of public needs in mental health issues, as teachers and mentors for students and other health professionals, as researchers in order to enrich our knowledge in the scientific field of psychiatry, and as public health specialists in the development of the mental health services system. This multifaceted role requires the continuous education of modern psychiatrists, but above all a broad, substantial and comprehensive training regime in the initial stage of their professional career, that is to say during specialization. Training in Psychiatry, as indeed has happened in all other medical specialties, has evolved considerably in recent decades, both in the content of education due to scientific advances in the fields of neurobiology, cognitive neuroscience, genetics, psychopharmacology, epidemiology and psychiatric nosology, and also because of advances in the educational process itself. Simple apprenticeship next to an experienced clinician, despite its importance in the clinical training of young psychiatrists, is no longer sufficient to meet the increased demands of the modern role of psychiatrists, resulting in the creation of educational programs defined by setting and pursuing minimum, though comprehensive educational objectives. This development has created the global need to develop organizations intended to supervise training programs. These organizations have various forms worldwide. In the European Union, the competent supervising body for medical specialties is the UEMS (European Union of Medical Specialities) and particularly in the case of the psychiatric

  2. Multivariate PAT solutions for biopharmaceutical cultivation: current progress and limitations

    NARCIS (Netherlands)

    Mercier, S.M.; Diepenbroek, B.; Wijffels, R.H.; Streefland, M.

    2014-01-01

    Increasingly elaborate and voluminous datasets are generated by the (bio)pharmaceutical industry and are a major challenge for application of PAT and QbD principles. Multivariate data analysis (MVDA) is required to delineate relevant process information from large multi-factorial and multi-collinear

  3. An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies.

    Science.gov (United States)

    Morar-Mitrica, Sorina; Adams, Monica L; Crotts, George; Wurth, Christine; Ihnat, Peter M; Tabish, Tanvir; Antochshuk, Valentyn; DiLuzio, Willow; Dix, Daniel B; Fernandez, Jason E; Gupta, Kapil; Fleming, Michael S; He, Bing; Kranz, James K; Liu, Dingjiang; Narasimhan, Chakravarthy; Routhier, Eric; Taylor, Katherine D; Truong, Nobel; Stokes, Elaine S E

    2018-02-01

    The Biophorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of best practices for the development of biopharmaceuticals. To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Point Share group conducted an intercompany collaboration exercise, which included a bench-marking survey and extensive group discussions around the scope, design, and execution of robustness studies. The results of this industry collaboration revealed several key common themes: (1) overall DP robustness is defined by both the formulation and the manufacturing process robustness; (2) robustness integrates the principles of quality by design (QbD); (3) DP robustness is an important factor in setting critical quality attribute control strategies and commercial specifications; (4) most companies employ robustness studies, along with prior knowledge, risk assessments, and statistics, to develop the DP design space; (5) studies are tailored to commercial development needs and the practices of each company. Three case studies further illustrate how a robustness study design for a biopharmaceutical DP balances experimental complexity, statistical power, scientific understanding, and risk assessment to provide the desired product and process knowledge. The BPDG-Formulation Point Share discusses identified industry challenges with regard to biopharmaceutical DP robustness and presents some recommendations for best practices. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  4. The successes and challenges of open-source biopharmaceutical innovation.

    Science.gov (United States)

    Allarakhia, Minna

    2014-05-01

    Increasingly, open-source-based alliances seek to provide broad access to data, research-based tools, preclinical samples and downstream compounds. The challenge is how to create value from open-source biopharmaceutical innovation. This value creation may occur via transparency and usage of data across the biopharmaceutical value chain as stakeholders move dynamically between open source and open innovation. In this article, several examples are used to trace the evolution of biopharmaceutical open-source initiatives. The article specifically discusses the technological challenges associated with the integration and standardization of big data; the human capacity development challenges associated with skill development around big data usage; and the data-material access challenge associated with data and material access and usage rights, particularly as the boundary between open source and open innovation becomes more fluid. It is the author's opinion that the assessment of when and how value creation will occur, through open-source biopharmaceutical innovation, is paramount. The key is to determine the metrics of value creation and the necessary technological, educational and legal frameworks to support the downstream outcomes of now big data-based open-source initiatives. The continued focus on the early-stage value creation is not advisable. Instead, it would be more advisable to adopt an approach where stakeholders transform open-source initiatives into open-source discovery, crowdsourcing and open product development partnerships on the same platform.

  5. Biopharmaceutical insights of particulate emulsified systems - a prospective overview.

    Science.gov (United States)

    Katamreddy, Jyothshna Devi; Yalavarthi, Prasanna Raju; D, Subba Rao; Battu, Sowjanya; Peesa, Jaya Preethi

    2018-05-10

    During the twenty-first century, drug discovery is expanding rapidly and a large number of chemical moieties are recognized. Many of them are poorly soluble and hence related biopharmaceutical constraints are to be addressed systematically. Among novel approaches to resolving biopharmaceutical issues, micro- and nano-emulsified systems serve as the best strategy for delivering both hydrophobic and hydrophilic drugs owing to their greater solubilization and transportation capabilities. Of late, the unique physical and biopharmaceutical properties of these liquid isotropic homogenous systems have gained substantive research importance. In addition nano/micro lipid systems share structural and functional similarity with that of the physiological lipids which offer better tolerance ability in the body. In this context, this article provides information on the historical emergence of particulate emulsified systems, importance and rationale of selection of carriers. It also encompasses the physicochemical principles that are responsible for the elevation of therapeutic outcomes of delivery systems. Detailed and schematic absorption of these drug delivery systems is explained here. Gastro-intestinal biochemistry necessary in the understanding of digestion process, lipolytic products formed, micellar structures, enzymes, transporters, mechanism of cell uptake involved after subsequent oral absorption are also emphasized. In addition, this article also explains disposition and pharmacokinetic properties of emulsified systems with real-time therapeutic research outcomes. The influence of biochemical compositions and biopharmaceutical principles on absorption and disposition patterns of ME/NEs was described in the article for the interest of readers and young researchers.

  6. Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets.

    Science.gov (United States)

    Vaithianathan, Soundarya; Raman, Siddarth; Jiang, Wenlei; Ting, Tricia Y; Kane, Maureen A; Polli, James E

    2015-07-06

    The therapeutic equivalence of generic and brand name antiepileptic drugs has been questioned by neurologists and the epilepsy community. A potential contributor to such concerns is pharmaceutical quality. The objective was to assess the biopharmaceutic risk of brand name Lamictal 100 mg tablets and generic lamotrigine 100 mg tablets from several manufacturers. Lamotrigine was characterized in terms of the Biopharmaceutics Classification System (BCS), including aqueous solubility and Caco-2 permeability. A panel of pharmaceutical quality tests was also performed on three batches of Lamictal, three batches of Teva generic, and one batch of each of four other generics: appearance, identity, assay, impurity, uniformity of dosage units, disintegration, dissolution, friability, and loss on drying. These market surveillance results indicate that all brand name and generic lamotrigine 100 mg tablets passed all tests and showed acceptable pharmaceutical quality and low biopharmaceutic risk. Lamotrigine was classified as a BCS class IIb drug, exhibiting pH-dependent aqueous solubility and dissolution. At pH 1.2 and 4.5, lamotrigine exhibited high solubility, whereas lamotrigine exhibited low solubility at pH 6.8, including non-sink dissolution. Lamotrigine showed high Caco-2 permeability. The apparent permeability (Papp) of lamotrigine was (73.7 ± 8.7) × 10(-6) cm/s in the apical-to-basolateral (AP-BL) direction and (41.4 ± 1.6) × 10(-6) cm/s in the BL-AP direction, which were higher than metoprolol's AP-BL Papp of (21.2 ± 0.9) × 10(-6) cm/s and BL-AP Papp of (34.6 ± 4.6) × 10(-6) cm/s. Overall, lamotrigine's favorable biopharmaceutics from a drug substance perspective and favorable quality characteristics from a tablet formulation perspective suggest that multisource lamotrigine tablets exhibit a low biopharmaceutic risk.

  7. Physician career satisfaction within specialties

    Directory of Open Access Journals (Sweden)

    Kravitz Richard L

    2009-09-01

    Full Text Available Abstract Background Specialty-specific data on career satisfaction may be useful for understanding physician workforce trends and for counseling medical students about career options. Methods We analyzed cross-sectional data from 6,590 physicians (response rate, 53% in Round 4 (2004-2005 of the Community Tracking Study Physician Survey. The dependent variable ranged from +1 to -1 and measured satisfaction and dissatisfaction with career. Forty-two specialties were analyzed with survey-adjusted linear regressions Results After adjusting for physician, practice, and community characteristics, the following specialties had significantly higher satisfaction levels than family medicine: pediatric emergency medicine (regression coefficient = 0.349; geriatric medicine (0.323; other pediatric subspecialties (0.270; neonatal/prenatal medicine (0.266; internal medicine and pediatrics (combined practice (0.250; pediatrics (0.250; dermatology (0.249;and child and adolescent psychiatry (0.203. The following specialties had significantly lower satisfaction levels than family medicine: neurological surgery (-0.707; pulmonary critical care medicine (-0.273; nephrology (-0.206; and obstetrics and gynecology (-0.188. We also found satisfaction was significantly and positively related to income and employment in a medical school but negatively associated with more than 50 work-hours per-week, being a full-owner of the practice, greater reliance on managed care revenue, and uncontrollable lifestyle. We observed no statistically significant gender differences and no differences between African-Americans and whites. Conclusion Career satisfaction varied across specialties. A number of stakeholders will likely be interested in these findings including physicians in specialties that rank high and low and students contemplating specialty. Our findings regarding "less satisfied" specialties should elicit concern from residency directors and policy makers since they

  8. Microtools for single-cell analysis in biopharmaceutical development and manufacturing.

    Science.gov (United States)

    Love, Kerry Routenberg; Bagh, Sangram; Choi, Jonghoon; Love, J Christopher

    2013-05-01

    Biologic drugs are promoting growth in the biopharmaceutical industry. Despite the clinical benefits of these drugs, the time and costs required to bring new biologics to market still are substantial. Three key challenges, among others, persist in the development of biologic drugs: namely, establishing product similarity, product toxicity, and global accessibility. New classes of microtools that facilitate the isolation and interrogation of single cells have the potential to impact each of these challenges. This opinion considers recent examples of microtools with demonstrated or potential utility to address problems in these areas. Integrating these advanced technologies into the development of new biologics could greatly reduce time and costs required to bring alternative products to market, and thus expand their global availability. Copyright © 2013 Elsevier Ltd. All rights reserved.

  9. Modeling in biopharmaceutics, pharmacokinetics and pharmacodynamics homogeneous and heterogeneous approaches

    CERN Document Server

    Macheras, Panos

    2016-01-01

    The state of the art in Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics Modeling is presented in this new second edition book. It shows how advanced physical and mathematical methods can expand classical models in order to cover heterogeneous drug-biological processes and therapeutic effects in the body. The book is divided into four parts; the first deals with the fundamental principles of fractals, diffusion and nonlinear dynamics; the second with drug dissolution, release, and absorption; the third with epirical, compartmental, and stochastic pharmacokinetic models, with two new chapters, one on fractional pharmacokinetics and one on bioequivalence; and the fourth mainly with classical and nonclassical aspects of pharmacodynamics. The classical models that have relevance and application to these sciences are also considered throughout. This second edition has new information on reaction limited models of dissolution, non binary biopharmaceutic classification system, time varying models, and interf...

  10. Safe handling of cytotoxic compounds in a biopharmaceutical environment.

    Science.gov (United States)

    Hensgen, Miriam I; Stump, Bernhard

    2013-01-01

    Handling cytotoxic drugs such as antibody-drug conjugates (ADCs) in a biopharmaceutical environment represents a challenge based on the potency of the compounds. These derivatives are dangerous to humans if they accidentally get in contact with the skin, are inhaled, or are ingested, either as pure compounds in their solid state or as a solution dissolved in a co-solvent. Any contamination of people involved in the manufacturing process has to be avoided. On the other hand, biopharmaceuticals need to be protected simultaneously against any contamination from the manufacturing personnel. Therefore, a tailor-made work environment is mandatory in order to manufacture ADCs. This asks for appropriate technical equipment to keep potential hazardous substances contained. In addition, clearly defined working procedures based on risk assessments as well as proper training for all personnel involved in the manufacturing process are needed to safely handle these highly potent pharmaceuticals.

  11. [Construction of biopharmaceutics classification system of Chinese materia medica].

    Science.gov (United States)

    Liu, Yang; Wei, Li; Dong, Ling; Zhu, Mei-Ling; Tang, Ming-Min; Zhang, Lei

    2014-12-01

    Based on the characteristics of multicomponent of traditional Chinese medicine and drawing lessons from the concepts, methods and techniques of biopharmaceutics classification system (BCS) in chemical field, this study comes up with the science framework of biopharmaceutics classification system of Chinese materia medica (CMMBCS). Using the different comparison method of multicomponent level and the CMMBCS method of overall traditional Chinese medicine, the study constructs the method process while setting forth academic thoughts and analyzing theory. The basic role of this system is clear to reveal the interaction and the related absorption mechanism of multicomponent in traditional Chinese medicine. It also provides new ideas and methods for improving the quality of Chinese materia medica and the development of new drug research.

  12. THE BIOPHARMACEUTICAL CLASSIFICATION SYSTEM (BCS): PRESENT STATUS AND FUTURE PROSPECTIVES

    OpenAIRE

    Budhwaar Vikaas; Nanda Arun

    2012-01-01

    The Biopharmaceutical classification system (BCS) was introduced By Amidon et al., (1995) as a method for classifying drug substances based on their dose/solubility ratio and intestinal permeability. It allows predicting the in vivo pharmacokinetic performance of drug products. The drug can be categorized into four classes of BCS, namely, High solubility high permeability, low solubility high permeability, High solubility low permeability and low solubility low permeability. An objective of B...

  13. BIOPHARMACEUTICS CLASSIFICATION SYSTEM: A STRATEGIC TOOL FOR CLASSIFYING DRUG SUBSTANCES

    OpenAIRE

    Rohilla Seema; Rohilla Ankur; Marwaha RK; Nanda Arun

    2011-01-01

    The biopharmaceutical classification system (BCS) is a scientific approach for classifying drug substances based on their dose/solubility ratio and intestinal permeability. The BCS has been developed to allow prediction of in vivo pharmacokinetic performance of drug products from measurements of permeability and solubility. Moreover, the drugs can be categorized into four classes of BCS on the basis of permeability and solubility namely; high permeability high solubility, high permeability lo...

  14. Just how good an investment is the biopharmaceutical sector?

    Science.gov (United States)

    Thakor, Richard T; Anaya, Nicholas; Zhang, Yuwei; Vilanilam, Christian; Siah, Kien Wei; Wong, Chi Heem; Lo, Andrew W

    2017-12-01

    Uncertainty surrounding the risk and reward of investments in biopharmaceutical companies poses a challenge to those interested in funding such enterprises. Using data on publicly traded stocks, we track the performance of 1,066 biopharmaceutical companies from 1930 to 2015-the most comprehensive financial analysis of this sector to date. Our systematic exploration of methods for distinguishing biotech and pharmaceutical companies yields a dynamic, more accurate classification method. We find that the performance of the biotech sector is highly sensitive to the presence of a few outlier companies, and confirm that nearly all biotech companies are loss-making enterprises, exhibiting high stock volatility. In contrast, since 2000, pharmaceutical companies have become increasingly profitable, with risk-adjusted returns consistently outperforming the market. The performance of all biopharmaceutical companies is subject not only to factors arising from their drug pipelines (idiosyncratic risk), but also from general economic conditions (systematic risk). The risk associated with returns has profound implications both for patterns of investment and for funding innovation in biomedical R&D.

  15. Delivery Systems for Biopharmaceuticals. Part I: Nanoparticles and Microparticles.

    Science.gov (United States)

    Silva, Ana C; Lopes, Carla M; Lobo, José M S; Amaral, Maria H

    2015-01-01

    Pharmaceutical biotechnology has been showing therapeutic success never achieved with conventional drug molecules. Therefore, biopharmaceutical products are currently well-established in clinic and the development of new ones is expected. These products comprise mainly therapeutic proteins, although nucleic acids and cells are also included. However, according to their sensitive molecular structures, the efficient delivery of biopharmaceuticals is challenging. Several delivery systems (e.g. microparticles and nanoparticles) composed of different materials (e.g. polymers and lipids) have been explored and demonstrated excellent outcomes, such as: high cellular transfection efficiency for nucleic acids, cell targeting, increased proteins and peptides bioavailability, improved immune response in vaccination, and viability maintenance of microencapsulated cells. Nonetheless, important issues need to be addressed before they reach clinics. For example, more in vivo studies in animals, accessing the toxicity potential and predicting in vivo failure of these delivery systems are required. This is the Part I of two review articles, which presents the state of the art of delivery systems for biopharmaceuticals. Part I deals with microparticles and polymeric and lipid nanoparticles.

  16. Principles for interactions with biopharmaceutical companies: the development of guidelines for patient advocacy organizations in the field of rare diseases.

    Science.gov (United States)

    Stein, Susan; Bogard, Elizabeth; Boice, Nicole; Fernandez, Vivian; Field, Tessa; Gilstrap, Alan; Kahn, Susan R; Larkindale, Jane; Mathieson, Toni

    2018-01-22

    Rare diseases are a global public health concern, affecting an estimated 350 million individuals. Only 5% of approximately 7000 known rare diseases have a treatment, and only about half have a patient advocacy organization. Biopharmaceutical companies face complex challenges in developing treatments for rare diseases. Patient advocacy organizations may play a major role by positively influencing research and development, clinical trials, and regulations. Thus, collaboration among patient advocacy organizations and industry is essential to bring new therapeutics to patients. We identified an unmet need for guidelines on day-to-day decision-making by rare disease patient advocacy organizations when working with biopharmaceutical partners. We convened an Independent Expert Panel experienced in collaborations between patient advocacy organizations and biopharmaceutical companies (April 2017) to develop consensus guidelines for these relationships. The guidelines were based on an original version by the International Fibrodysplasia Ossificans Progressiva Association (IFOPA). The Expert Panel reviewed and broadened these to be applicable to all patient advocacy organizations. Comments on the draft Guidelines were provided first by Panel participants and subsequently by six independent experts from patient advocacy organizations and industry. The Panel comprised four experts from the rare disease community who lead patient advocacy organizations; three leaders who perform advocacy functions within biopharmaceutical companies; and two facilitators, both having leadership experience in rare diseases and industry. The finalized Guidelines consist of four main sections: Identification and Engagement With Companies, Patient Engagement and Patient Privacy, Financial Contributions, and Clinical Trial Communication and Support. The Guidelines address the daily considerations, choices, and consequences of patient advocacy organizations as they engage with biopharmaceutical

  17. Specialty Guidelines for Forensic Psychology

    Science.gov (United States)

    American Psychologist, 2013

    2013-01-01

    In the past 50 years forensic psychological practice has expanded dramatically. Because the practice of forensic psychology differs in important ways from more traditional practice areas (Monahan, 1980) the "Specialty Guidelines for Forensic Psychologists" were developed and published in 1991 (Committee on Ethical Guidelines for Forensic…

  18. A new large-scale manufacturing platform for complex biopharmaceuticals.

    Science.gov (United States)

    Vogel, Jens H; Nguyen, Huong; Giovannini, Roberto; Ignowski, Jolene; Garger, Steve; Salgotra, Anil; Tom, Jennifer

    2012-12-01

    Complex biopharmaceuticals, such as recombinant blood coagulation factors, are addressing critical medical needs and represent a growing multibillion-dollar market. For commercial manufacturing of such, sometimes inherently unstable, molecules it is important to minimize product residence time in non-ideal milieu in order to obtain acceptable yields and consistently high product quality. Continuous perfusion cell culture allows minimization of residence time in the bioreactor, but also brings unique challenges in product recovery, which requires innovative solutions. In order to maximize yield, process efficiency, facility and equipment utilization, we have developed, scaled-up and successfully implemented a new integrated manufacturing platform in commercial scale. This platform consists of a (semi-)continuous cell separation process based on a disposable flow path and integrated with the upstream perfusion operation, followed by membrane chromatography on large-scale adsorber capsules in rapid cycling mode. Implementation of the platform at commercial scale for a new product candidate led to a yield improvement of 40% compared to the conventional process technology, while product quality has been shown to be more consistently high. Over 1,000,000 L of cell culture harvest have been processed with 100% success rate to date, demonstrating the robustness of the new platform process in GMP manufacturing. While membrane chromatography is well established for polishing in flow-through mode, this is its first commercial-scale application for bind/elute chromatography in the biopharmaceutical industry and demonstrates its potential in particular for manufacturing of potent, low-dose biopharmaceuticals. Copyright © 2012 Wiley Periodicals, Inc.

  19. History of Medical Specialty Interest Assessment

    Science.gov (United States)

    Burns, Stephanie T.

    2016-01-01

    Medical specialties require decidedly different abilities, skills, and talents; which results in divergent experiences, lifestyles, skill sets, and income levels. To help medical students select their preferred medical specialty and alleviate shortages in medical specialty staffing, US medical schools and associations invest time and money in…

  20. Consumer cost sharing and use of biopharmaceuticals for rheumatoid arthritis.

    Science.gov (United States)

    Robinson, James C

    2013-06-01

    To evaluate the effect of consumer cost sharing on use of physician-administered and patient self-administered specialty drugs for rheumatoid arthritis. Multivariate statistical analysis of probability and use of physician-administered specialty drugs, patient self-injected specialty drugs, non-biologic disease-modifying anti-rheumatic drugs, and symptom relief drugs. Analyses were conducted for patients enrolling in preferred provider organization (PPO) plans and health maintenance organization (HMO) plans with different cost-sharing requirements, adjusted for patient demographics, health status, and geographical location. Professional, facility, and pharmaceutical claims for beneficiaries of CalPERS, the public employee insurance purchasing alliance in California, for 2008-2009. Consumer cost-sharing requirements were obtained for each type of drug and service for each type of insurance plan. PPO insurance enrollees face substantially higher cost sharing for physician-administered specialty drugs, compared with HMO enrollees in CalPERS. PPO patients with rheumatoid arthritis are only half as likely as HMO enrollees to choose a physician-administered specialty drug (4.2% vs 9.3%) (P ≤.05), and use 25% less of the drugs if they use any ($10,356 vs $13,678) (P ≤.05). They are 30% more likely to use a self-administered specialty drug than are HMO enrollees (29.3% vs 22.1%) (P ≤.05), and use 35% more of the drugs if any ($16,015 vs $12,378) (P ≤.05). Consumer cost sharing reduces the use of physician-administered specialty drugs for rheumatoid arthritis. The higher use of patient self-administered specialty drugs suggests that the disincentives for use of physician-administered drugs were offset by an increased incentive to use self-administered drugs.

  1. Glyco-engineering for biopharmaceutical production in moss bioreactors

    Directory of Open Access Journals (Sweden)

    Eva L. Decker

    2014-07-01

    Full Text Available The production of recombinant biopharmaceuticals (pharmaceutical proteins is a strongly growing area in the pharmaceutical industry. While most products to date are produced in mammalian cell cultures, namely CHO cells, plant-based production systems gained increasing acceptance over the last years. Different plant systems have been established which are suitable for standardization and precise control of cultivation conditions, thus meeting the criteria for pharmaceutical production.The majority of biopharmaceuticals comprise glycoproteins. Therefore, differences in protein glycosylation between humans and plants have to be taken into account and plant-specific glycosylation has to be eliminated to avoid adverse effects on quality, safety and efficacy of the products.The basal land plant Physcomitrella patens (moss has been employed for the recombinant production of high-value therapeutic target proteins (e.g., Vascular Endothelial Growth Factor, Complement Factor H, monoclonal antibodies, Erythropoietin. Being genetically excellently characterized and exceptionally amenable for precise gene targeting via homologous recombination, essential steps for the optimization of moss as a bioreactor for the production of recombinant proteins have been undertaken.Here, we discuss the glyco-engineering approaches to avoid non-human N- and O-glycosylation on target proteins produced in moss bioreactors.

  2. Online examiner calibration across specialties.

    Science.gov (United States)

    Sturman, Nancy; Wong, Wai Yee; Turner, Jane; Allan, Chris

    2017-09-26

    Integrating undergraduate medical curricula horizontally across clinical medical specialties may be a more patient-centred and learner-centred approach than rotating students through specialty-specific teaching and assessment, but requires some interspecialty calibration of examiner judgements. Our aim was to evaluate the acceptability and feasibility of an online pilot of interdisciplinary examiner calibration. Fair clinical assessment is important to both medical students and clinical teachers METHODS: Clinical teachers were invited to rate video-recorded student objective structured clinical examination (OSCE) performances and join subsequent online discussions using the university's learning management system. Post-project survey free-text and Likert-scale participant responses were analysed to evaluate the acceptability of the pilot and to identify recommendations for improvement. Although 68 clinicians were recruited to participate, and there were 1599 hits on recordings and discussion threads, only 25 clinical teachers rated at least one student performance, and 18 posted at least one comment. Participants, including rural doctors, appeared to value the opportunity for interdisciplinary rating calibration and discussion. Although the asynchronous online format had advantages, especially for rural doctors, participants reported considerable IT challenges. Our findings suggest that fair clinical assessment is important to both medical students and clinical teachers. Interspecialty discussions about assessment may have the potential to enrich intraspecialty perspectives, enhance interspecialty engagement and collaboration, and improve the quality of clinical teacher assessment. Better alignment of university and hospital systems, a face to face component and other modifications may have enhanced clinician engagement with this project. Findings suggest that specialty assessment cultures and content expertise may not be barriers to pursuing more integrated

  3. CROHN'S DISEASE: GENERAL CHARACTERISTICS AND TREATMENT WITH ADALIMUMABE BIOPHARMACEUTICAL

    Directory of Open Access Journals (Sweden)

    S. A. Marques

    2018-02-01

    Full Text Available Crohn's Disease (CD is a chronic inflammatory disease that affects the gastrointestinal system. The etiology is not fully understood, however, genetic, immunological, microbiological and environmental factors are related to its genesis. The most common manifestations of this disease are diarrhea, abdominal pain, ulcers and fistulas. In the absence of adequate treatment it can evolve into extra intestinal complications and is also an important risk factor for colon and rectal cancer. The treatment of the disease is palliative and there is no cure for the disease, being considered only the period of remission of symptoms, as a good prognosis. The biopharmaceutical, Adalimumabe, produced by recombinant DNA technology has demonstrated efficacy in the treatment of this disease, as it prevents the action of TNF-α, a cytokine involved in inflammation and is abundant in individuals with CD. Although Adalimumabe has good results, its use leads to side effects that can be mild or fatal, such as the activation of tuberculosis.

  4. Single-use disposable technologies for biopharmaceutical manufacturing.

    Science.gov (United States)

    Shukla, Abhinav A; Gottschalk, Uwe

    2013-03-01

    The manufacture of protein biopharmaceuticals is conducted under current good manufacturing practice (cGMP) and involves multiple unit operations for upstream production and downstream purification. Until recently, production facilities relied on the use of relatively inflexible, hard-piped equipment including large stainless steel bioreactors and tanks to hold product intermediates and buffers. However, there is an increasing trend towards the adoption of single-use technologies across the manufacturing process. Technical advances have now made an end-to-end single-use manufacturing facility possible, but several aspects of single-use technology require further improvement and are continually evolving. This article provides a perspective on the current state-of-the-art in single-use technologies and highlights trends that will improve performance and increase the market penetration of disposable manufacturing in the future. Copyright © 2012 Elsevier Ltd. All rights reserved.

  5. Carrot cells: a pioneering platform for biopharmaceuticals production.

    Science.gov (United States)

    Rosales-Mendoza, Sergio; Tello-Olea, Marlene Anahí

    2015-03-01

    Carrot (Daucus carota L.) is of importance in the molecular farming field as it constitutes the first plant species approved to produce biopharmaceuticals for human use. In this review, features that make carrot an advantageous species in the molecular farming field are analyzed and a description of the developments achieved with this crop thus far is presented. A guide for genetic transformation procedures is also included. The state of the art comprises ten vaccine prototypes against Measles virus, Hepatitis B virus, Human immunodeficiency virus, Yersinia pestis, Chlamydia trachomatis, Mycobacterium tuberculosis, enterotoxigenic Escherichia coli, Corynebacterium diphtheria/Clostridium tetani/Bordetella pertussis, and Helicobacter pylori; as well as the case of the glucocerebrosidase, an enzyme used for replacement therapy, and other therapeutics. Perspectives for these developments are envisioned and innovations are proposed such as the use of transplastomic technologies-, hairy roots-, and viral expression-based systems to improve yields and develop new products derived from this advantageous plant species.

  6. Modeling in biopharmaceutics, pharmacokinetics, and pharmacodynamics homogeneous and heterogeneous approaches

    CERN Document Server

    Macheras, Panos

    2006-01-01

    The state of the art in Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics Modeling is presented in this book. It shows how advanced physical and mathematical methods can expand classical models in order to cover heterogeneous drug-biological processes and therapeutic effects in the body. The book is divided into four parts; the first deals with the fundamental principles of fractals, diffusion and nonlinear dynamics; the second with drug dissolution, release, and absorption; the third with empirical, compartmental, and stochastic pharmacokinetic models, and the fourth mainly with nonclassical aspects of pharmacodynamics. The classical models that have relevance and application to these sciences are also considered throughout. Many examples are used to illustrate the intrinsic complexity of drug administration related phenomena in the human, justifying the use of advanced modeling methods. This timely and useful book will appeal to graduate students and researchers in pharmacology, pharmaceutical scienc...

  7. Synthetic Biology for Specialty Chemicals.

    Science.gov (United States)

    Markham, Kelly A; Alper, Hal S

    2015-01-01

    In this review, we address recent advances in the field of synthetic biology and describe how those tools have been applied to produce a wide variety of chemicals in microorganisms. Here we classify the expansion of the synthetic biology toolbox into three different categories based on their primary function in strain engineering-for design, for construction, and for optimization. Next, focusing on recent years, we look at how chemicals have been produced using these new synthetic biology tools. Advances in producing fuels are briefly described, followed by a more thorough treatment of commodity chemicals, specialty chemicals, pharmaceuticals, and nutraceuticals. Throughout this review, an emphasis is placed on how synthetic biology tools are applied to strain engineering. Finally, we discuss organism and host strain diversity and provide a future outlook in the field.

  8. Capillary electrophoresis – mass spectrometry using noncovalently coated capillaries for the analysis of biopharmaceuticals

    NARCIS (Netherlands)

    Haselberg, R.

    2010-01-01

    With efficient methodologies available in biotechnology today, increasing numbers of recombinantly manufactured pharmaceutical peptides and proteins are being commercialized. The assessment of biopharmaceutical quality in terms of identity, content and purity is an important issue during

  9. Capacity Planning for Batch and Perfusion Bioprocesses Across Multiple Biopharmaceutical Facilities

    OpenAIRE

    Siganporia, Cyrus C; Ghosh, Soumitra; Daszkowski, Thomas; Papageorgiou, Lazaros G; Farid, Suzanne S

    2014-01-01

    Production planning for biopharmaceutical portfolios becomes more complex when products switch between fed-batch and continuous perfusion culture processes. This article describes the development of a discrete-time mixed integer linear programming (MILP) model to optimize capacity plans for multiple biopharmaceutical products, with either batch or perfusion bioprocesses, across multiple facilities to meet quarterly demands. The model comprised specific features to account for products with fe...

  10. Factors Influencing Medical Students' Choice of Specialty

    Directory of Open Access Journals (Sweden)

    Pei-Yeh Chang

    2006-01-01

    Conclusion: This study found that personal intelligence/ability preference and career opportunities were more important factors to the current generation of students in choosing a specialty. Knowledge of these students' attitudes could form the basis for the development of strategies to enhance the attractiveness of specialties facing the problem of a shortage of manpower.

  11. Social Dominance Theory and Medical Specialty Choice

    Science.gov (United States)

    Lepièce, Brice; Reynaert, Christine; van Meerbeeck, Philippe; Dory, Valérie

    2016-01-01

    Understanding how medical students select their specialty is a fundamental issue for public health and educational policy makers. One of the factors that students take into account is a specialty's prestige which hinges partly on its focus on technique rather than whole person. We examine the potential of a psychological framework, social…

  12. Regulatory policy and the location of bio-pharmaceutical foreign direct investment in Europe.

    Science.gov (United States)

    Koenig, Pamina; Macgarvie, Megan

    2011-09-01

    This paper examines the relationship between cross-country differences in drug price regulation and the location of biopharmaceutical Foreign Direct Investment (FDI) in Europe. Simple theory predicts that price regulation in one country might affect total investment, but not the location of that investment, if sales are global. Nevertheless, some manufacturers threaten that the introduction of price regulation in a country will motivate them to move their investments to other countries. Are such threats cheap talk, or is there evidence that firms avoid price-controlling countries when making FDI location choices? We use data on 527 investments initiated in 27 European countries between 2002 and 2009 and find that investors are less likely to choose countries with price controls, after controlling for other determinants of investment. We also observe a relative decline in investment in countries that increased the stringency of regulatory regimes during our sample period. The effect is restricted to non-manufacturing investments and is most robust for those related to administrative functions. Copyright © 2011 Elsevier B.V. All rights reserved.

  13. Lifetime earnings for physicians across specialties.

    Science.gov (United States)

    Leigh, J Paul; Tancredi, Daniel; Jerant, Anthony; Romano, Patrick S; Kravitz, Richard L

    2012-12-01

    Earlier studies estimated annual income differences across specialties, but lifetime income may be more relevant given physicians' long-term commitments to specialties. Annual income and work hours data were collected from 6381 physicians in the nationally representative 2004-2005 Community Tracking Study. Data regarding years of residency were collected from AMA FREIDA. Present value models were constructed assuming 3% discount rates. Estimates were adjusted for demographic and market covariates. Sensitivity analyses included 4 alternative models involving work hours, retirement, exogenous variables, and 1% discount rate. Estimates were generated for 4 broad specialty categories (Primary Care, Surgery, Internal Medicine and Pediatric Subspecialties, and Other), and for 41 specific specialties. The estimates of lifetime earnings for the broad categories of Surgery, Internal Medicine and Pediatric Subspecialties, and Other specialties were $1,587,722, $1,099,655, and $761,402 more than for Primary Care. For the 41 specific specialties, the top 3 (with family medicine as reference) were neurological surgery ($2,880,601), medical oncology ($2,772,665), and radiation oncology ($2,659,657). The estimates from models with varying rates of retirement and including only exogenous variables were similar to those in the preferred model. The 1% discount model generated estimates that were roughly 150% larger than the 3% model. There was considerable variation in the lifetime earnings across physician specialties. After accounting for varying residency years and discounting future earnings, primary care specialties earned roughly $1-3 million less than other specialties. Earnings' differences across specialties may undermine health reform efforts to control costs and ensure adequate numbers of primary care physicians.

  14. Biopharmaceutics classification system: importance and inclusion in biowaiver guidance

    Directory of Open Access Journals (Sweden)

    Lorena Barbosa Arrunátegui

    2015-03-01

    Full Text Available Pharmacological therapy is essential in many diseases treatment and it is important that the medicine policy is intended to offering safe and effective treatment with affordable price to the population. One way to achieve this is through biowaiver, defined as the replacement of in vivo bioequivalence studies by in vitro studies. For biowaiver of new immediate release solid oral dosage forms, data such as intestinal permeability and solubility of the drug are required, as well as the product dissolution. The Biopharmaceutics Classification System (BCS is a scientific scheme that divides drugs according to their solubility and permeability and has been used by various guides as a criterion for biowaiver. This paper evaluates biowaiver application, addressing the general concepts and parameters used by BCS, making a historical account of its use, the requirements pertaining to the current legislation, the benefits and risks associated with this decision. The results revealed that the use of BCS as a biowaiver criterion greatly expands the therapeutics options, contributing to greater therapy access of the general population with drug efficacy and safety guaranteed associated to low cost.

  15. Ion-exchange chromatography for the characterization of biopharmaceuticals.

    Science.gov (United States)

    Fekete, Szabolcs; Beck, Alain; Veuthey, Jean-Luc; Guillarme, Davy

    2015-09-10

    Ion-exchange chromatography (IEX) is a historical technique widely used for the detailed characterization of therapeutic proteins and can be considered as a reference and powerful technique for the qualitative and quantitative evaluation of charge heterogeneity. The goal of this review is to provide an overview of theoretical and practical aspects of modern IEX applied for the characterization of therapeutic proteins including monoclonal antibodies (Mabs) and antibody drug conjugates (ADCs). The section on method development describes how to select a suitable stationary phase chemistry and dimensions, the mobile phase conditions (pH, nature and concentration of salt), as well as the temperature and flow rate, considering proteins isoelectric point (pI). In addition, both salt-gradient and pH-gradient approaches were critically reviewed and benefits as well as limitations of these two strategies were provided. Finally, several applications, mostly from pharmaceutical industries, illustrate the potential of IEX for the characterization of charge variants of various types of biopharmaceutical products. Copyright © 2015 Elsevier B.V. All rights reserved.

  16. Factors Influencing Medical Students' Choice of Specialty

    OpenAIRE

    Chang, Pei-Yeh; Hung, Chih-Young; Wang, Kuei-lng; Huang, Yuan-Huei; Chang, King-Jen

    2006-01-01

    Medical school graduates are the source of a country's physicians. Determining how the graduates of these schools select their areas of specialization is the key to achieving a balanced distribution of doctors among all specialties. The purposes of this study were to determine the factors that influence medical students' choice of medical specialty, and to derive the relative weight of each factor. Methods: We constructed a two-tiered analytic hierarchy process (AHP) model which was repres...

  17. Role of Knowledge Management in Development and Lifecycle Management of Biopharmaceuticals.

    Science.gov (United States)

    Rathore, Anurag S; Garcia-Aponte, Oscar Fabián; Golabgir, Aydin; Vallejo-Diaz, Bibiana Margarita; Herwig, Christoph

    2017-02-01

    Knowledge Management (KM) is a key enabler for achieving quality in a lifecycle approach for production of biopharmaceuticals. Due to the important role that it plays towards successful implementation of Quality by Design (QbD), an analysis of KM solutions is needed. This work provides a comprehensive review of the interface between KM and QbD-driven biopharmaceutical production systems as perceived by academic as well as industrial viewpoints. A comprehensive set of 356 publications addressing the applications of KM tools to QbD-related tasks were screened and a query to gather industrial inputs from 17 major biopharmaceutical organizations was performed. Three KM tool classes were identified as having high relevance for biopharmaceutical production systems and have been further explored: knowledge indicators, ontologies, and process modeling. A proposed categorization of 16 distinct KM tool classes allowed for the identification of holistic technologies supporting QbD. In addition, the classification allowed for addressing the disparity between industrial and academic expectations regarding the application of KM methodologies. This is a first of a kind attempt and thus we think that this paper would be of considerable interest to those in academia and industry that are engaged in accelerating development and commercialization of biopharmaceuticals.

  18. The Value of Specialty Oncology Drugs

    Science.gov (United States)

    Goldman, Dana P; Jena, Anupam B; Lakdawalla, Darius N; Malin, Jennifer L; Malkin, Jesse D; Sun, Eric

    2010-01-01

    Objective To estimate patients' elasticity of demand, willingness to pay, and consumer surplus for five high-cost specialty medications treating metastatic disease or hematologic malignancies. Data Source/Study Setting Claims data from 71 private health plans from 1997 to 2005. Study Design This is a revealed preference analysis of the demand for specialty drugs among cancer patients. We exploit differences in plan generosity to examine how utilization of specialty oncology drugs varies with patient out-of-pocket costs. Data Collection/Extraction Methods We extracted key variables from administrative health insurance claims records. Principal Findings A 25 percent reduction in out-of-pocket costs leads to a 5 percent increase in the probability that a patient initiates specialty cancer drug therapy. Among patients who initiate, a 25 percent reduction in out-of-pocket costs reduces the number of treatments (claims) by 1–3 percent, depending on the drug. On average, the value of these drugs to patients who use them is about four times the total cost paid by the patient and his or her insurer, although this ratio may be lower for oral specialty therapies. Conclusions The decision to initiate therapy with specialty oncology drugs is responsive to price, but not highly so. Among patients who initiate therapy, the amount of treatment is equally responsive. The drugs we examine are highly valued by patients in excess of their total costs, although oral agents warrant further scrutiny as copayments increase. PMID:19878344

  19. Impact of Postapproval Evidence Generation on the Biopharmaceutical Industry.

    Science.gov (United States)

    Milne, Christopher-Paul; Cohen, Joshua P; Felix, Abigail; Chakravarthy, Ranjana

    2015-08-01

    Meeting marketplace demands for proving the value of new products requires more data than the industry has routinely produced. These data include evidence from comparative effectiveness research (CER), including randomized, controlled trials; pragmatic clinical trials; observational studies; and meta-analyses. We designed and conducted a survey to examine the industry's perceptions on new data requirements regarding CER evidence, the acceptability of postapproval study types, payer-specific issues related to CER, communication of data being generated postapproval, and methods used for facilitating postapproval evidence generation. CER is being used by payers for most types of postapproval decisions. Randomized, controlled trials were indicated as the most acceptable form of evidence. At the same time, there was support for the utility of other types of studies, such as pragmatic clinical trials and observational studies. Respondents indicated the use of multiple formats for communicating postapproval data with many different stakeholders including regulators, payers, providers, and patients. Risk-sharing agreements with payers were unanimously supported by respondents with regard to certain products with unclear clinical and economic outcomes at launch. In these instances, conditional reimbursement through coverage with evidence development was considered a constructive option. The Food and Drug Administration's initiative called Regulatory Science was considered by the respondents as having the most impact on streamlining the generation of postapproval research-related evidence. The biopharmaceutical industry is faced with a broad and complex set of challenges related to evidence generation for postapproval decisions by a variety of health care system stakeholders. Uncertainty remains as to how the industry and payers use postapproval studies to guide decision making with regard to pricing and reimbursement status. Correspondingly, there is uncertainty regarding

  20. Globalization

    Directory of Open Access Journals (Sweden)

    Tulio Rosembuj

    2006-12-01

    Full Text Available There is no singular globalization, nor is the result of an individual agent. We could start by saying that global action has different angles and subjects who perform it are different, as well as its objectives. The global is an invisible invasion of materials and immediate effects.

  1. Globalization

    OpenAIRE

    Tulio Rosembuj

    2006-01-01

    There is no singular globalization, nor is the result of an individual agent. We could start by saying that global action has different angles and subjects who perform it are different, as well as its objectives. The global is an invisible invasion of materials and immediate effects.

  2. Hybrid and Disposable Facilities for Manufacturing of Biopharmaceuticals: Pros and Cons

    Science.gov (United States)

    Ravisé, Aline; Cameau, Emmanuelle; de Abreu, Georges; Pralong, Alain

    Modern biotechnology has grown over the last 35 years to a maturing industry producing and delivering high-value biopharmaceuticals that yield important medical and economical benefits. The constantly increasing need for biopharmaceuticals and significant costs related to time-consuming R&D work makes this industry risky and highly competitive. This trend is confirmed by the important number of biopharmaceuticals that are actually under development at all stages by all major pharmaceutical industry companies. A consequence of this evolution is an increasing need for development and manufacturing capacity. The build up of traditional - stainless steel - technology is complicated, time consuming and very expensive. The decision for such a major investment needs to be taken early in the development cycle of a promising drug to cope with future demands for clinical trials and product launch. Possibilities for the reduction of R&D and manufacturing costs are therefore of significant interest in order to be competitive.

  3. Examining the sources of variability in cell culture media used for biopharmaceutical production.

    Science.gov (United States)

    McGillicuddy, Nicola; Floris, Patrick; Albrecht, Simone; Bones, Jonathan

    2018-01-01

    Raw materials, in particular cell culture media, represent a significant source of variability to biopharmaceutical manufacturing processes that can detrimentally affect cellular growth, viability and specific productivity or alter the quality profile of the expressed therapeutic protein. The continual expansion of the biopharmaceutical industry is creating an increasing demand on the production and supply chain consistency for cell culture media, especially as companies embrace intensive continuous processing. Here, we provide a historical perspective regarding the transition from serum containing to serum-free media, the development of chemically-defined cell culture media for biopharmaceutical production using industrial scale bioprocesses and review production mechanisms for liquid and powder culture media. An overview and critique of analytical approaches used for the characterisation of cell culture media and the identification of root causes of variability are also provided, including in-depth liquid phase separations, mass spectrometry and spectroscopic methods.

  4. 78 FR 61358 - Mylan, Inc., Agila Specialties Global Pte. Limited, Agila Specialties Private Limited and Strides...

    Science.gov (United States)

    2013-10-03

    ... following the instructions on the web-based form. If you prefer to file your comment on paper, mail or... instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home . you also may...--Mylan, [[Page 61360

  5. Dental students' perceptions of dental specialties and factors influencing specialty and career choices.

    Science.gov (United States)

    Dhima, Matilda; Petropoulos, Vicki C; Han, Rita K; Kinnunen, Taru; Wright, Robert F

    2012-05-01

    The goals of this study were to 1) evaluate dental students' perceptions of dental specialties, 2) identify factors that play an important role in students' decision to pursue specialty training or career choices, and 3) establish a baseline of students' perceptions of the dental fields with the best future in terms of salary, personal and patient quality of life, and overall impact on the dental profession. Surveys were distributed to 494 students at the University of Pennsylvania School of Dental Medicine. Data were collected from 380 traditional four-year students and thirty advanced standing students. Chi-square tests, multivariate analysis, and logistic regressions were used to determine associations and independent contributions of student demographics to their perceptions of dental specialties and factors influencing specialty training or career choices. Debt was a statistically significant factor (p<0.001) in choosing specialty training or career independent of gender, age, or class year. Enjoyment of providing care in a specialty or field was identified as the single most important factor in choosing a specialty career. Half of the respondents had decided not to specialize. Pursuing postdoctoral general dentistry training and private practice in general dentistry were the most commonly reported plans after completion of dental school. Suggestions are made for ways to inform students about specialty training.

  6. Factors affecting membership in specialty nursing organizations.

    Science.gov (United States)

    White, Mary Joe; Olson, Rhonda S

    2004-01-01

    A discouraging trend in many specialty nursing organizations is the stagnant or declining membership. The research committee of the Southeast Texas Chapter of the Association of Rehabilitation Nurses (ARN) collected data and studied this trend to determine what changes would be necessary to increase membership. Using Herzberg's motivational theory as a framework, a review of the literature was initiated. There were few current studies on this issue, but relevant information was found about nursing's emerging workforce, as well as implications of the growth of magnet hospitals, which affect whether nurses join specialty nursing organizations. A multifaceted data-collection approach using convenience samples was designed. First, relevant literature was reviewed. Second, a survey was sent by e-mail to other ARN chapters. Third, a telephone survey on other specialty organizations in the geographic region was completed. Finally, members of the local ARN chapter and four other specialty organizations, as well staff nurses in the geographic area, were given questionnaires to complete. Descriptive statistics and cross tabulations were used to determine why nurses do and do not join specialty organizations (N = 81). The most frequent reasons for joining an organization were to increase knowledge, benefit professionally, network, and earn continuing education units. Reasons for choosing not to participate were family responsibilities, lack of information about these organizations, and lack of time. Ways to reverse the decline in membership are discussed.

  7. Specialty Choice Among Sexual and Gender Minorities in Medicine: The Role of Specialty Prestige, Perceived Inclusion, and Medical School Climate.

    Science.gov (United States)

    Sitkin, Nicole A; Pachankis, John E

    2016-12-01

    Sexual and gender minorities (SGMs) in medicine experience unique stressors in training. However, little is known about SGM specialty choice. This study examined predictors of SGM specialty choice, associations between specialty prestige and perceived SGM inclusion, and self-reported influences on specialty choice. Medical trainees and practitioners (358 SGM, 1528 non-SGM) were surveyed online. We operationalized specialty choice at the individual level as respondents' specialty of practice; at the specialty level, as a percentage of SGM respondents in each specialty. We examined specialty prestige, perceived SGM inclusivity, and medical school climate as predictors of SGM specialty choice, and we compared additional influences on specialty choice between SGM and non-SGM. The percentage of SGM in each specialty was inversely related to specialty prestige (P = 0.001) and positively related to perceived SGM inclusivity (P = 0.01). Prestigious specialties were perceived as less SGM inclusive (P gender identity strongly influenced specialty choice (P role models, and work-life balance as strong influences on specialty choice. Exposure as a medical student to SGM faculty did not predict specialty prestige among SGM. Specialty prestige and perceived inclusivity predict SGM specialty choice. SGM diversity initiatives in prestigious specialties may be particularly effective by addressing SGM inclusion directly. Further research is needed to inform effective mentorship for SGM medical students. Exposure to SGM in medical training reduces anti-SGM bias among medical professionals, and SGM in medicine often assume leadership roles in clinical care, education, and research regarding SGM health. Supporting and promoting SGM diversity across the spectrum of medical specialties, therefore, represents a critical avenue to improve the care delivered to SGM populations and addresses the role of providers in the health disparities experienced by SGM.

  8. Specialty Choice Among Sexual and Gender Minorities in Medicine: The Role of Specialty Prestige, Perceived Inclusion, and Medical School Climate

    Science.gov (United States)

    Pachankis, John E.

    2016-01-01

    Abstract Purpose: Sexual and gender minorities (SGMs) in medicine experience unique stressors in training. However, little is known about SGM specialty choice. This study examined predictors of SGM specialty choice, associations between specialty prestige and perceived SGM inclusion, and self-reported influences on specialty choice. Methods: Medical trainees and practitioners (358 SGM, 1528 non-SGM) were surveyed online. We operationalized specialty choice at the individual level as respondents' specialty of practice; at the specialty level, as a percentage of SGM respondents in each specialty. We examined specialty prestige, perceived SGM inclusivity, and medical school climate as predictors of SGM specialty choice, and we compared additional influences on specialty choice between SGM and non-SGM. Results: The percentage of SGM in each specialty was inversely related to specialty prestige (P = 0.001) and positively related to perceived SGM inclusivity (P = 0.01). Prestigious specialties were perceived as less SGM inclusive (P gender identity strongly influenced specialty choice (P work–life balance as strong influences on specialty choice. Exposure as a medical student to SGM faculty did not predict specialty prestige among SGM. Conclusion: Specialty prestige and perceived inclusivity predict SGM specialty choice. SGM diversity initiatives in prestigious specialties may be particularly effective by addressing SGM inclusion directly. Further research is needed to inform effective mentorship for SGM medical students. Exposure to SGM in medical training reduces anti-SGM bias among medical professionals, and SGM in medicine often assume leadership roles in clinical care, education, and research regarding SGM health. Supporting and promoting SGM diversity across the spectrum of medical specialties, therefore, represents a critical avenue to improve the care delivered to SGM populations and addresses the role of providers in the health disparities

  9. Globalization

    OpenAIRE

    Andru?cã Maria Carmen

    2013-01-01

    The field of globalization has highlighted an interdependence implied by a more harmonious understanding determined by the daily interaction between nations through the inducement of peace and the management of streamlining and the effectiveness of the global economy. For the functioning of the globalization, the developing countries that can be helped by the developed ones must be involved. The international community can contribute to the institution of the development environment of the gl...

  10. [Infectious diseases - a specialty of internal medicine].

    Science.gov (United States)

    Fätkenheuer, G; Jung, N; Kern, W V; Fölsch, U R; Salzberger, B

    2018-04-01

    Infectious diseases have recently gained wide public interest. Emerging infections and rising rates of antibiotic resistance are determining this trend. Both challenges will need to be addressed in international and local collaborations between different specialties in medicine and basic science. Infectious diseases as a clinical specialty in this scenario is directly responsible for the care of patients with infectious diseases. Its involvement in the care of patients with complicated infections has proved to be highly effective. Antibiotic stewardship programmes are effective measures in slowing the development of antibiotic resistance and have been widely implemented. But antibiotic stewardship specialists should not be confused with or taken as an alternative to infectious disease experts. Infectious diseases requires appropriate and specific training. It mainly uses the instrumentarium of internal medicine. With the current challenges in modern medicine, infectious diseases in Germany should thus be upgraded from a subspecialty to a clinical specialty, ideally within Internal Medicine.

  11. The long overdue medical specialty: bioethiatrics.

    Science.gov (United States)

    Kevorkian, J

    1986-11-01

    Traditional bioethical codes have been unable to cope with the results of modern technology and the drastic changes in life patterns. The medical profession can reestablish bioethical order and reassert leadership through a new and urgently needed medical specialty, which the author tentatively calls bioethiatrics or bioethiatry. Bioethiatrics embodies a unique combination of ethical action and moral judgment.Training for the specialty would start with a residency program, consisting of thorough training in philosophy and religion coupled with continued experience in clinical medicine and indoctrination in contemporary research. Requirements would include the practice of general medicine for at least two years after internship, the passing of oral and written examinations after four years of residency, board certification, and subsequent periodic evaluations.Bioethiatricians would assume all the usual privileges, obligations, and risks associated with the practice of any medical specialty, thereby averting unnecessary ethical crises and ensuring a more rational response to present and future moral challenges.

  12. Capillary electrophoresis – mass spectrometry using noncovalently coated capillaries for the analysis of biopharmaceuticals

    OpenAIRE

    Haselberg, R.

    2010-01-01

    With efficient methodologies available in biotechnology today, increasing numbers of recombinantly manufactured pharmaceutical peptides and proteins are being commercialized. The assessment of biopharmaceutical quality in terms of identity, content and purity is an important issue during manufacturing. The biotechnological production process may show variability, which can introduce product diversity, isoforms and closely-related degradation products. Clearly, there is an increasing demand fo...

  13. Biotechnological production of pharmaceuticals and biopharmaceuticals in plant cell and organ cultures.

    Science.gov (United States)

    Hidalgo, Diego; Sanchez, Raul; Lalaleo, Liliana; Bonfill, Mercedes; Corchete, Purificacion; Palazon, Javier

    2018-03-09

    Plant biofactories are biotechnological platforms based on plant cell and organ cultures used for the production of pharmaceuticals and biopharmaceuticals, although to date only a few of these systems have successfully been implemented at an industrial level. Metabolic engineering is possibly the most straightforward strategy to boost pharmaceutical production in plant biofactories, but social opposition to the use of GMOs means empirical approaches are still being used. Plant secondary metabolism involves thousands of different enzymes, some of which catalyze specific reactions, giving one product from a particular substrate, whereas others can yield multiple products from the same substrate. This trait opens plant cell biofactories to new applications, in which the natural metabolic machinery of plants can be harnessed for the bioconversion of phytochemicals or even the production of new bioactive compounds. Synthetic biological pipelines involving the bioconversion of natural substrates into products with a high market value may be established by the heterologous expression of target metabolic genes in model plants. To summarize the state of the art of plant biofactories and their applications for the pipeline production of cosme-, pharma- and biopharmaceuticals. In order to demonstrate the great potential of plant biofactories for multiple applications in the biotechnological production of pharmaceuticals and biopharmaceuticals, this review broadly covers the following: plant biofactories based on cell and hairy root cultures; secondary metabolite production; biotransformation reactions; metabolic engineering tools applied in plant biofactories; and biopharmaceutical production. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  14. Guidance to Achieve Accurate Aggregate Quantitation in Biopharmaceuticals by SV-AUC.

    Science.gov (United States)

    Arthur, Kelly K; Kendrick, Brent S; Gabrielson, John P

    2015-01-01

    The levels and types of aggregates present in protein biopharmaceuticals must be assessed during all stages of product development, manufacturing, and storage of the finished product. Routine monitoring of aggregate levels in biopharmaceuticals is typically achieved by size exclusion chromatography (SEC) due to its high precision, speed, robustness, and simplicity to operate. However, SEC is error prone and requires careful method development to ensure accuracy of reported aggregate levels. Sedimentation velocity analytical ultracentrifugation (SV-AUC) is an orthogonal technique that can be used to measure protein aggregation without many of the potential inaccuracies of SEC. In this chapter, we discuss applications of SV-AUC during biopharmaceutical development and how characteristics of the technique make it better suited for some applications than others. We then discuss the elements of a comprehensive analytical control strategy for SV-AUC. Successful implementation of these analytical control elements ensures that SV-AUC provides continued value over the long time frames necessary to bring biopharmaceuticals to market. © 2015 Elsevier Inc. All rights reserved.

  15. Formulation Strategies and Particle Engineering Technologies for Pulmonary Delivery of Biopharmaceuticals

    DEFF Research Database (Denmark)

    Cun, Dongmei; Wan, Feng; Yang, Mingshi

    2015-01-01

    . In this review we discussed the formulation strategies and particle engineering technologies to improve the efficiency of pulmonary delivery of biopharmaceutical, with a focus on systemic therapy of pharmaceutical proteins/peptides and local delivery of siRNA via the lung administration....

  16. Innovator Organizations in New Drug Development: Assessing the Sustainability of the Biopharmaceutical Industry.

    Science.gov (United States)

    Kinch, Michael S; Moore, Ryan

    2016-06-23

    The way new medicines are discovered and brought to market has fundamentally changed over the last 30 years. Our previous analysis showed that biotechnology companies had contributed significantly to the US Food and Drug Administration approval of new molecular entities up to the mid-1980s, when the trends started to decline. Although intriguing, the focus on biotechnology necessarily precluded the wider question of how the biopharmaceutical industry has been delivering on its goals to develop new drugs. Here, we present a comprehensive analysis of all biopharmaceutical innovators and uncover unexpected findings. The present biopharmaceutical industry grew steadily from 1800 to 1950 and then stagnated for two decades, before a burst of growth attributable to the biotechnology revolution took place; but consolidation has reduced the number of active and independent innovators to a level not experienced since 1945. The trajectories and trends we observe raise fundamental questions about biopharmaceutical innovators and the sustainability of the drug-development enterprise. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Vulnerability of California specialty crops to projected mid-century temperature changes

    Science.gov (United States)

    Increasing global temperatures are likely to have major impacts on agriculture, but the effects will vary by crop and location. This paper describes the temperature sensitivity and exposure of selected specialty crops in California. We used literature synthesis to create several sensitivity indices ...

  18. Specialty Choices: Patterns and Determinants among Medical ...

    African Journals Online (AJOL)

    2017-07-18

    Jul 18, 2017 ... Methods: This was a cross‑sectional questionnaire‑based survey carried out ... were preferentially influenced by family/societal expectations (P = 0.03) and ..... Table 5: Distribution of specialties of first choice by age, parent's ...

  19. Immunogenicity of biopharmaceuticals and biosimilars in relation to storage, handling and stability

    International Nuclear Information System (INIS)

    Hincal, F.

    2009-01-01

    Therapeutic proteins or biopharmaceuticals provide effective treatment for many diseases and medical conditions, and vaccines, immunoglobulins and monoclonal antibodies are critical biodefense biopharmaceuticals which constitute an indispensable part of biodefense stockpiles. The manufacturing process for biopharmaceuticals and their generic forms which are called biosimilars is far more complex than for low molecular weight drugs and generics. Any minor change made at any stage may have a critical effect on the clinical efficacy and safety. Potential immunogenicity is the key issue for biopharmaceuticals and biosimilars and may have serious clinical consequences ranging from allergy and anaphylaxis, as well as loss of efficacy of the product. Immunogenicity may be influenced by factors related to manufacturing process, formulation, aggregate formation, contaminants and impurities, and also by the factors related to the storage and handling. Stability is particularly important with larger protein molecules, because their in vivo effects often depend on their three-dimensional structure. Proteins usually aggregate from partially unfolded molecules and aggregates can enhance immunogenicity. Although product formulations are developed to maximize and maintain the fraction of the protein molecules present in the native state, significant amounts of aggregates can form, especially over pharmaceutically relevant time scales and under stress conditions. Exposure to air-liquid and solid-liquid interfaces, light, temperature fluctuations or minor impurities can induce aggregation. Such exposure can occur during processing steps, as well as in the final product container during storage, shipment and handling. Biopharmaceuticals are particularly sensitive to temperature changes and/or shaking. Strict storage and handling conditions and timely and effective stability/shelf-life testing are therefore essential for maintaining product integrity and stability, and hence efficacy

  20. Globalization

    DEFF Research Database (Denmark)

    Plum, Maja

    Globalization is often referred to as external to education - a state of affair facing the modern curriculum with numerous challenges. In this paper it is examined as internal to curriculum; analysed as a problematization in a Foucaultian sense. That is, as a complex of attentions, worries, ways...... of reasoning, producing curricular variables. The analysis is made through an example of early childhood curriculum in Danish Pre-school, and the way the curricular variable of the pre-school child comes into being through globalization as a problematization, carried forth by the comparative practices of PISA...

  1. Globalization

    OpenAIRE

    F. Gerard Adams

    2008-01-01

    The rapid globalization of the world economy is causing fundamental changes in patterns of trade and finance. Some economists have argued that globalization has arrived and that the world is “flat†. While the geographic scope of markets has increased, the author argues that new patterns of trade and finance are a result of the discrepancies between “old†countries and “new†. As the differences are gradually wiped out, particularly if knowledge and technology spread worldwide, the t...

  2. Recent trends in specialty pharma business model

    Directory of Open Access Journals (Sweden)

    Mannching Sherry Ku

    2015-12-01

    Full Text Available The recent rise of specialty pharma is attributed to its flexible, versatile, and open business model while the traditional big pharma is facing a challenging time with patent cliff, generic threat, and low research and development (R&D productivity. These multinational pharmaceutical companies, facing a difficult time, have been systematically externalizing R&D and some even establish their own corporate venture capital so as to diversify with more shots on goal, with the hope of achieving a higher success rate in their compound pipeline. Biologics and clinical Phase II proof-of-concept (POC compounds are the preferred licensing and collaboration targets. Biologics enjoys a high success rate with a low generic biosimilar threat, while the need is high for clinical Phase II POC compounds, due to its high attrition/low success rate. Repurposing of big pharma leftover compounds is a popular strategy but with limitations. Most old compounds come with baggage either in lackluster clinical performance or short in patent life. Orphan drugs is another area which has gained popularity in recent years. The shorter and less costly regulatory pathway provides incentives, especially for smaller specialty pharma. However, clinical studies on orphan drugs require a large network of clinical operations in many countries in order to recruit enough patients. Big pharma is also working on orphan drugs starting with a small indication, with the hope of expanding the indication into a blockbuster status. Specialty medicine, including orphan drugs, has become the growth engine in the pharmaceutical industry worldwide. Big pharma is also keen on in-licensing technology or projects from specialty pharma to extend product life cycles, in order to protect their blockbuster drug franchises. Ample opportunities exist for smaller players, even in the emerging countries, to collaborate with multinational pharmaceutical companies provided that the technology platforms or

  3. Recent trends in specialty pharma business model.

    Science.gov (United States)

    Ku, Mannching Sherry

    2015-12-01

    The recent rise of specialty pharma is attributed to its flexible, versatile, and open business model while the traditional big pharma is facing a challenging time with patent cliff, generic threat, and low research and development (R&D) productivity. These multinational pharmaceutical companies, facing a difficult time, have been systematically externalizing R&D and some even establish their own corporate venture capital so as to diversify with more shots on goal, with the hope of achieving a higher success rate in their compound pipeline. Biologics and clinical Phase II proof-of-concept (POC) compounds are the preferred licensing and collaboration targets. Biologics enjoys a high success rate with a low generic biosimilar threat, while the need is high for clinical Phase II POC compounds, due to its high attrition/low success rate. Repurposing of big pharma leftover compounds is a popular strategy but with limitations. Most old compounds come with baggage either in lackluster clinical performance or short in patent life. Orphan drugs is another area which has gained popularity in recent years. The shorter and less costly regulatory pathway provides incentives, especially for smaller specialty pharma. However, clinical studies on orphan drugs require a large network of clinical operations in many countries in order to recruit enough patients. Big pharma is also working on orphan drugs starting with a small indication, with the hope of expanding the indication into a blockbuster status. Specialty medicine, including orphan drugs, has become the growth engine in the pharmaceutical industry worldwide. Big pharma is also keen on in-licensing technology or projects from specialty pharma to extend product life cycles, in order to protect their blockbuster drug franchises. Ample opportunities exist for smaller players, even in the emerging countries, to collaborate with multinational pharmaceutical companies provided that the technology platforms or specialty medicinal

  4. A qualitative study on physicians' perceptions of specialty characteristics.

    Science.gov (United States)

    Park, Kwi Hwa; Jun, Soo-Koung; Park, Ie Byung

    2016-09-01

    There has been limited research on physicians' perceptions of the specialty characteristics that are needed to sustain a successful career in medical specialties in Korea. Medical Specialty Preference Inventory in the United States or SCI59 (specialty choice inventory) in the United Kingdom are implemented to help medical students plan their careers. The purpose of this study was to explore the characteristics of the major specialties in Korea. Twelve physicians from different specialties participated in an exploratory study consisting of qualitative interviews about the personal ability and emotional characteristics and job attributes of each specialty. The collected data were analysed with content analysis methods. Twelve codes were extracted for ability & skill attributes, 23 codes for emotion & attitude attributes, and 12 codes for job attributes. Each specialty shows a different profile in terms of its characteristic attributes. The findings have implications for the design of career planning programs for medical students.

  5. A qualitative study on physicians' perceptions of specialty characteristics

    Directory of Open Access Journals (Sweden)

    Kwi Hwa Park

    2016-09-01

    Full Text Available Purpose: There has been limited research on physicians’ perceptions of the specialty characteristics that are needed to sustain a successful career in medical specialties in Korea. Medical Specialty Preference Inventory in the United States or SCI59 (specialty choice inventory in the United Kingdom are implemented to help medical students plan their careers. The purpose of this study was to explore the characteristics of the major specialties in Korea. Methods: Twelve physicians from different specialties participated in an exploratory study consisting of qualitative interviews about the personal ability and emotional characteristics and job attributes of each specialty. The collected data were analysed with content analysis methods. Results: Twelve codes were extracted for ability & skill attributes, 23 codes for emotion & attitude attributes, and 12 codes for job attributes. Each specialty shows a different profile in terms of its characteristic attributes. Conclusion: The findings have implications for the design of career planning programs for medical students.

  6. medical students' preference for choice of clinical specialties

    African Journals Online (AJOL)

    Zamzar

    This study seeks to determine the medical student preference for the clinical specialty and the factors that they consider in making ... undergraduates in selecting these specialties is important. .... effect of National Health Insurance on changes.

  7. Globalização e cafés especiais: a produção do comércio justo da Associação dos Agricultores Familiares do Córrego D’Antas - ASSODANTAS, Poços de Caldas (MG / Globalization and specialty coffees: the Fair trade production of Associação dos Agricultores Familiares do Córrego D’Antas - ASSODANTAS, Poços de Caldas (MG

    Directory of Open Access Journals (Sweden)

    Samuel Frederico

    2015-12-01

    Full Text Available Since the last major international coffee crisis, in the 1990s, the production of specialty coffee has been considered one of the main market alternatives for small farmers. However, the increase in world consumption of this type of coffee has also attracted the attention of major exporters, roasters and retailers, with consequent standardization of production. On the one hand, the entry in such markets has important benefits for small producers, particularly in countries recognized by the production of lower quality coffee and insufficient collective organization of farmers, as the Brazilian case, on the other hand, external regulation and the role of large companies have extended the differences of power and distribution of value along the productive spacial circuit. Therefore, this article aim to examine the paradox resulting from the insertion of small producers of the Associação dos Agricultores familiares do Córrego D’Antas, Poços de Caldas (MG, in the Fairtrade market. For this, starts the debate on globalization and standardization of specialty coffee production. Then deepens the analysis in Fairtrade and finally, it highlight the benefits and challenges faced by Assodantas.

  8. Specialty choice among dental students in Ibadan, Nigeria ...

    African Journals Online (AJOL)

    The majority of dental students at the University of Ibadan preferred the oral and maxillofacial surgery (OMS) specialty above all other dental specialties, while prosthetic dentistry was least preferred. Of all the factors to take into consideration when choosing a dental specialty, personal interest was the only factor considered ...

  9. Gender variations in specialties among medical doctors working in ...

    African Journals Online (AJOL)

    Background: Gender variations exist in the choice of specialties among ... as it affects the distribution of doctors in public health institutions and patient care. ... For female doctors,pediatrics was the topmost specialty (25%) followed by ... Keywords: Gender variation,Specialties,Doctors,Public healthcare,Health workforce ...

  10. [A new specialty is born: Vascular medicine].

    Science.gov (United States)

    Laroche, J-P

    2016-05-01

    On the 4th of December 2015, the French authorities officially recognized the birth of a specialty in vascular medicine entitled CO-DES cardiology-vascular/vascular Medicine. France is the 7th country to obtain this specialty after Switzerland, Germany, Austria, Czech Republic, Slovakia and Slovenia, six countries in the EEC. It has taken years to achieve a long but exciting experience: we went from hopes to disappointments, sometimes with the blues, but lobbying helping… with sustained confidence. This article tells the story of 30 years of struggle to achieve this vascular medicine specialty. Gaston Bachelard wrote: "Nothing is obvious, nothing is given, all is built." For the construction of vascular medicine, we had to overcome many obstacles, nothing was given to us, everything was conquered. Beware "The specialist is one who knows more and more things about an increasingly restricted field, up to 'knowing everything about nothing"' recalled Ralph Barton Ferry, philosopher; so there is room for modesty and humility but also convictions. The physical examination will remain the basis of our exercise. But let us recall the contributions of all those vascular physicians who practiced in the past, together with those currently active, who built day after day, year after year, a vascular medicine of quality. It is because of the trust of our colleagues and our patients that we can occupy the place that is ours today. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  11. Summary of the NICHD-BPCA Pediatric Formulation Initiatives Workshop-Pediatric Biopharmaceutics Classification System (PBCS) Working Group

    OpenAIRE

    Abdel-Rahman, Susan; Amidon, Gordon L.; Kaul, Ajay; Lukacova, Viera; Vinks, Alexander A.; Knipp, Gregory

    2012-01-01

    The Biopharmaceutics Classification System (BCS) allows compounds to be classified based on their in vitro solubility and intestinal permeability. The BCS has found widespread use in the pharmaceutical community as an enabling guide for the rational selection of compounds, formulation for clinical advancement and generic biowaivers. The Pediatric Biopharmaceutics Classification System (PBCS) working group was convened to consider the possibility of developing an analogous pediatric based clas...

  12. Theoretical Model of Professional Competence Development in Dual-Specialty Students (On the Example of the "History, Religious Studies" Specialty)

    Science.gov (United States)

    Karimova, A. E.; Amanova, A. S.; Sadykova, A. M.; Kuzembaev, N. E.; Makisheva, A. T.; Kurmangazina, G. Zh.; Sakenov, Janat

    2016-01-01

    The article explores the significant problem of developing a theoretical model of professional competence development in dual-specialty students (on the example of the "History, Religious studies" specialty). In order to validate the specifics of the professional competence development in dual-specialty students (on the example of the…

  13. Manufacturing, regulatory and commercial challenges of biopharmaceuticals production: a Finnish perspective.

    Science.gov (United States)

    Närhi, Marko; Nordström, Katrina

    2005-04-01

    Biopharmaceuticals product development is a broad and multidisciplinary field. Science and technology are combined with new manufacturing, regulatory and commercial challenges. However, although there is ample literature on the molecular biology and biochemistry of products, the implementation of processes from test tube to commercial scale has not received similar attention. Consequently, the present study aims to highlight, from practical point of view, some of the key issues involved with manufacturing technologies of biopharmaceuticals at a commercial scale. Regulatory requirements and investments are also addressed based on the practical experiences of start-up and small companies. Finland is used as a case-example of such companies as this is a EU-member state with strong technological growth and rapidly increasing number of biotech companies.

  14. Antibodies Against Complement Components: Relevance for the Antiphospholipid Syndrome-Biomarkers of the Disease and Biopharmaceuticals.

    Science.gov (United States)

    Bećarević, Mirjana

    2017-07-01

    Laboratory criterion for the diagnosis of antiphospholipid syndrome (APS) is the presence of antiphospholipid antibodies (aPL Abs). Complement system has a role in mediating aPL Abs-induced thrombosis in animal models. The importance of antibodies against complement components (potential biomarkers of APS) and the importance of antibodies with beneficial anti-complement effects in APS (as biopharmaceuticals) are reviewed. Antibodies against complement components described in APS patients, so far, are anti-C1q and anti-factor H Abs, although anti-factor B Abs and anti-C5a Abs were described in animal models of APS. Clinical studies in APS patients are limited to a small number of case reports. Studies that would confirm potential role of Abs against complement components (as potential biomarkers of APS) are lacking. Lack of randomized clinical trials (that would provide complete data for confirmation of beneficial effects of biopharmaceuticals in complement inhibition) in APS is alarming.

  15. Cellular targets for improved manufacturing of virus-based biopharmaceuticals in animal cells.

    Science.gov (United States)

    Rodrigues, Ana F; Carrondo, Manuel J T; Alves, Paula M; Coroadinha, Ana S

    2014-12-01

    The past decade witnessed the entry into the market of new virus-based biopharmaceuticals produced in animal cells such as oncolytic vectors, virus-like particle vaccines, and gene transfer vectors. Therefore, increased attention and investment to optimize cell culture processes towards enhanced manufacturing of these bioproducts is anticipated. Herein, we review key findings on virus-host interactions that have been explored in cell culture optimization. Approaches supporting improved productivity or quality of vector preparations are discussed, mainly focusing on medium design and genetic manipulation. This review provides an integrated outline for current and future efforts in exploring cellular targets for the optimization of cell culture manufacturing of virus-based biopharmaceuticals. Copyright © 2014 Elsevier Ltd. All rights reserved.

  16. [Study on biopharmaceutics classification system for Chinese materia medica of extract of Huanglian].

    Science.gov (United States)

    Liu, Yang; Yin, Xiu-Wen; Wang, Zi-Yu; Li, Xue-Lian; Pan, Meng; Li, Yan-Ping; Dong, Ling

    2017-11-01

    One of the advantages of biopharmaceutics classification system of Chinese materia medica (CMMBCS) is expanding the classification research level from single ingredient to multi-components of Chinese herb, and from multi-components research to holistic research of the Chinese materia medica. In present paper, the alkaloids of extract of huanglian were chosen as the main research object to explore their change rules in solubility and intestinal permeability of single-component and multi-components, and to determine the biopharmaceutical classification of extract of Huanglian from holistic level. The typical shake-flask method and HPLC were used to detect the solubility of single ingredient of alkaloids from extract of huanglian. The quantitative research of alkaloids in intestinal absorption was measured in single-pass intestinal perfusion experiment while permeability coefficient of extract of huanglian was calculated by self-defined weight coefficient method. Copyright© by the Chinese Pharmaceutical Association.

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

    OpenAIRE

    Waldron, Kelly

    2017-01-01

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

  18. Hybrid and disposable facilities for manufacturing of biopharmaceuticals: pros and cons.

    Science.gov (United States)

    Ravisé, Aline; Cameau, Emmanuelle; De Abreu, Georges; Pralong, Alain

    2009-01-01

    Modern biotechnology has grown over the last 35 years to a maturing industry producing and delivering high-value biopharmaceuticals that yield important medical and economical benefits. The constantly increasing need for biopharmaceuticals and significant costs related to time-consuming R&D work makes this industry risky and highly competitive. This trend is confirmed by the important number of biopharmaceuticals that are actually under development at all stages by all major pharmaceutical industry companies. A consequence of this evolution is an increasing need for development and manufacturing capacity. The build up of traditional - stainless steel - technology is complicated, time consuming and very expensive. The decision for such a major investment needs to be taken early in the development cycle of a promising drug to cope with future demands for clinical trials and product launch. Possibilities for the reduction of R&D and manufacturing costs are therefore of significant interest in order to be competitive.In this chapter, four case studies are presented which outline ways to reduce significantly R&D and manufacturing costs by using disposable technology in the frame of a the transfer of an antibody manufacturing process, the preparation of media and buffers in commercial manufacturing and a direct comparison of a traditional and a fully disposable pilot plant.

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

    Science.gov (United States)

    Challa, Shruthi; Potumarthi, Ravichandra

    2013-01-01

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

  20. Delivery systems for biopharmaceuticals. Part II: Liposomes, Micelles, Microemulsions and Dendrimers.

    Science.gov (United States)

    Silva, Ana C; Lopes, Carla M; Lobo, José M S; Amaral, Maria H

    2015-01-01

    Biopharmaceuticals are a generation of drugs that include peptides, proteins, nucleic acids and cell products. According to their particular molecular characteristics (e.g. high molecular size, susceptibility to enzymatic activity), these products present some limitations for administration and usually parenteral routes are the only option. To avoid these limitations, different colloidal carriers (e.g. liposomes, micelles, microemulsions and dendrimers) have been proposed to improve biopharmaceuticals delivery. Liposomes are promising drug delivery systems, despite some limitations have been reported (e.g. in vivo failure, poor long-term stability and low transfection efficiency), and only a limited number of formulations have reached the market. Micelles and microemulsions require more studies to exclude some of the observed drawbacks and guarantee their potential for use in clinic. According to their peculiar structures, dendrimers have been showing good results for nucleic acids delivery and a great development of these systems during next years is expected. This is the Part II of two review articles, which provides the state of the art of biopharmaceuticals delivery systems. Part II deals with liposomes, micelles, microemulsions and dendrimers.

  1. Organizational readiness in specialty mental health care.

    Science.gov (United States)

    Hamilton, Alison B; Cohen, Amy N; Young, Alexander S

    2010-01-01

    Implementing quality improvement efforts in clinics is challenging. Assessment of organizational "readiness" for change can set the stage for implementation by providing information regarding existing strengths and deficiencies, thereby increasing the chance of a successful improvement effort. This paper discusses organizational assessment in specialty mental health, in preparation for improving care for individuals with schizophrenia. To assess organizational readiness for change in specialty mental health in order to facilitate locally tailored implementation strategies. EQUIP-2 is a site-level controlled trial at nine VA medical centers (four intervention, five control). Providers at all sites completed an organizational readiness for change (ORC) measure, and key stakeholders at the intervention sites completed a semi-structured interview at baseline. At the four intervention sites, 16 administrators and 43 clinical staff completed the ORC, and 38 key stakeholders were interviewed. The readiness domains of training needs, communication, and change were the domains with lower mean scores (i.e., potential deficiencies) ranging from a low of 23.8 to a high of 36.2 on a scale of 10-50, while staff attributes of growth and adaptability had higher mean scores (i.e., potential strengths) ranging from a low of 35.4 to a high of 41.1. Semi-structured interviews revealed that staff perceptions and experiences of change and decision-making are affected by larger structural factors such as change mandates from VA headquarters. Motivation for change, organizational climate, staff perceptions and beliefs, and prior experience with change efforts contribute to readiness for change in specialty mental health. Sites with less readiness for change may require more flexibility in the implementation of a quality improvement intervention. We suggest that uptake of evidence-based practices can be enhanced by tailoring implementation efforts to the strengths and deficiencies of the

  2. Emergency medicine as a specialty in Asia.

    Science.gov (United States)

    Pek, Jen Heng; Lim, Swee Han; Ho, Hiu Fai; Ramakrishnan, T V; Jamaluddin, Sabariah Faizah; Mesa-Gaerlan, Faith Joan C; Tiru, Mohan; Hwang, Sung Oh; Choi, Wai-Mau; Kanchanasut, Somchai; Khruekarnchana, Pairoj; Avsarogullari, Levent; Shimazu, Takeshi; Hori, Shingo

    2016-04-01

    We aim to examine the similarities and differences in areas of EM development, workload, workforce, and capabilities and support in the Asia region. Emerging challenges faced by our EM community are also discussed. The National Societies for Emergency Medicine of Hong Kong, India, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand and Turkey participated in the joint Japanese Association of Acute Medicine (JAAM) and Asian Conference of Emergency Medicine (ACEM) Special Symposium held in October 2013 at Tokyo, Japan. The findings are reviewed in this paper. Emergency medicine (EM) has over the years evolved into a distinct and recognized medical discipline requiring a unique set of cognitive, administrative and technical skills for managing all types of patients with acute illness or injury. EM has contributed to healthcare by providing effective, safe, efficient and cost-effective patient care. Integrated systems have developed to allow continuity of emergency care from the community into emergency departments. Structured training curriculum for undergraduates, and specialty training programs for postgraduates are in place to equip trainees with the knowledge and skills required for the unique practice of EM. The practice of EM still varies among the Asian countries. However, as a region, we strive to continue in our efforts to develop the specialty and improve the delivery of EM.

  3. Therapeutic monoclonal antibodies: scFv patents as a marker of a new class of potential biopharmaceuticals

    Directory of Open Access Journals (Sweden)

    Manuela Berto Pucca

    2011-03-01

    Full Text Available Monoclonal antibodies represent the fastest growing class of biopharmaceutical products and have a host of applications in medical research, diagnosis, therapy, and basic science. The production of recombinant monoclonal antibodies has revolutionized the generation of immunoglobulins, and their use represents a strategic breakthrough, affecting the global pharmaceutical market for therapeutic proteins. In the present work, a review of scFv, and the number of related patents, has been carried out. The results show that several countries have scFv patents, most notably the United States, China and United Kingdom. The target of these scFv antibodies was also assessed and the results demonstrate that most are directed toward cancer therapy.Anticorpos monoclonais representam a classe de maior crescimento em produtos de biofármacos e possuem várias aplicações em pesquisa médica, diagnóstico, terapias e ciência básica. A produção de anticorpos monoclonais recombinantes revolucionou a geração de imunoglobulinas e sua utilização implica em avanço estratégico, afetando o mercado farmacêutico global de proteínas terapêuticas. No presente trabalho, uma revisão sobre scFv e a relação do seu número de patentes foi analisada. Os resultados mostram que vários países apresentam patentes de scFv com destaque para os Estados Unidos, China e Reino Unido. Os alvos desses anticorpos também foram avaliados e as análises revelaram que a maioria é destinado a terapias contra o câncer.

  4. Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool.

    Science.gov (United States)

    Zimmermann, Hartmut F; Hentschel, Norbert

    2011-01-01

    With the publication of the quality guideline ICH Q9 "Quality Risk Management" by the International Conference on Harmonization, risk management has already become a standard requirement during the life cycle of a pharmaceutical product. Failure mode and effect analysis (FMEA) is a powerful risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to biopharmaceutical processes brings about some difficulties. The proposal presented here is intended to serve as a brief but nevertheless comprehensive and detailed guideline on how to conduct a biopharmaceutical process FMEA. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. The application for such a biopharmaceutical process FMEA is widespread. It can be useful whenever a biopharmaceutical manufacturing process is developed or scaled-up, or when it is transferred to a different manufacturing site. It may also be conducted during substantial optimization of an existing process or the development of a second-generation process. According to their resulting risk ratings, process parameters can be ranked for importance and important variables for process development, characterization, or validation can be identified. Health authorities around the world ask pharmaceutical companies to manage risk during development and manufacturing of pharmaceuticals. The so-called failure mode and effect analysis (FMEA) is an established risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to pharmaceutical processes that use modern biotechnology (biopharmaceutical processes) brings about some difficulties, because those biopharmaceutical processes differ from processes in mechanical and electrical industries. The proposal presented here

  5. Protein N-glycosylation in eukaryotic microalgae and its impact on the production of nuclear expressed biopharmaceuticals

    Directory of Open Access Journals (Sweden)

    Elodie eMathieu-Rivet

    2014-07-01

    Full Text Available Microalgae are currently used for the production of food compounds. Recently, few microalgae species have been investigated as potential biofactories for the production of biopharmaceuticals. Indeed in this context, microalgae are cheap, classified as Generally Recognized As Safe (GRAS organisms and can be grown easily. However, problems remain to be solved before any industrial production of microalgae-made biopharmaceuticals. Among them, post-translational modifications of the proteins need to be considered. Especially, N-glycosylation acquired by the secreted recombinant proteins is of major concern since most of the biopharmaceuticals are N-glycosylated and it is well recognized that glycosylation represent one of their critical quality attribute. Therefore, the evaluation of microalgae as alternative cell factory for biopharmaceutical productions thus requires to investigate their N-glycosylation capability in order to determine to what extend it differs from their human counterpart and to determine appropriate strategies for remodelling the microalgae glycosylation into human-compatible oligosaccharides. Here, we review the secreted recombinant proteins which have been successfully produced in microalgae. We also report on recent bioinformatics and biochemical data concerning the structure of glycans N-linked to proteins from various microalgae phyla and comment the consequences on the glycan engineering strategies that may be necessary to render those microalgae-made biopharmaceuticals compatible with human therapy.

  6. Factors affecting future specialty choice among medical students in Kuwait.

    Science.gov (United States)

    Al-Fouzan, Rawan; Al-Ajlan, Sarah; Marwan, Yousef; Al-Saleh, Mervat

    2012-01-01

    Choosing a medical specialty can be either a daunting and confusing experience for some medical students and junior doctors or a foregone conclusion to others. The aim of this study is to evaluate factors affecting future specialty choice among medical students in Kuwait University. A self-administered questionnaire was used to collect data from medical students registered in Kuwait University during the academic year 2011/2012. Chi-square test and logistic regression were used to test the association between deciding a future specialty and students' sociodemographic and academic factors. Of the 422 students approached, 387 (91.7%) decided to participate. A total of 144 (37.2%) students made a decision regarding their choice of future medical specialty. Pediatrics, general surgery, and cardiology were the most desired specialties - 18 (12.5%), 17 (11.8%), and 16 (11.1%) students requested these specialties, respectively. Only 61 (42.4%) of those who selected a future specialty received advice regarding their choice. Looking for a good treatment outcome for patients (66; 45.8%) and a challenging specialty (58; 40.3%) were the most influencing incentives when selecting a future specialty. Students in the clinical phase of their study were 3.014 (95% CI: 1.498-6.065) more likely to report on their decision regarding a future specialty compared to students in the basic medical sciences phase (p=0.002). A variety of factors appeared to inspire medical students in Kuwait to choose a future medical specialty. When identified, these factors can be used by mentors of medical students and directors of residency training programs to motivate students to choose specialties that are limited in Kuwait.

  7. Factors affecting future specialty choice among medical students in Kuwait

    Directory of Open Access Journals (Sweden)

    Rawan Al-Fouzan

    2012-12-01

    Full Text Available Background: Choosing a medical specialty can be either a daunting and confusing experience for some medical students and junior doctors or a foregone conclusion to others. The aim of this study is to evaluate factors affecting future specialty choice among medical students in Kuwait University. Methods: A self-administered questionnaire was used to collect data from medical students registered in Kuwait University during the academic year 2011/2012. Chi-square test and logistic regression were used to test the association between deciding a future specialty and students’ sociodemographic and academic factors. Results: Of the 422 students approached, 387 (91.7% decided to participate. A total of 144 (37.2% students made a decision regarding their choice of future medical specialty. Pediatrics, general surgery, and cardiology were the most desired specialties – 18 (12.5%, 17 (11.8%, and 16 (11.1% students requested these specialties, respectively. Only 61 (42.4% of those who selected a future specialty received advice regarding their choice. Looking for a good treatment outcome for patients (66; 45.8% and a challenging specialty (58; 40.3% were the most influencing incentives when selecting a future specialty. Students in the clinical phase of their study were 3.014 (95% CI: 1.498–6.065 more likely to report on their decision regarding a future specialty compared to students in the basic medical sciences phase (p=0.002. Conclusion : A variety of factors appeared to inspire medical students in Kuwait to choose a future medical specialty. When identified, these factors can be used by mentors of medical students and directors of residency training programs to motivate students to choose specialties that are limited in Kuwait.

  8. Sampling and farm stories prompt consumers to buy specialty cheeses

    OpenAIRE

    Reed, Barbara A.; Bruhn, Christine M.

    2003-01-01

    California specialty cheese makers need information on what drives product sales so they can effectively market their products. Focus group and telephone research revealed that specialty cheese consumers have a strong preference for sampling cheese before making a purchase. Consumers also rely heavily on staff recommendations to select cheese. They appreciate unlimited sampling in an unhurried, low-pressure environment. Specialty cheese consumers consider themselves “food experimenters”; they...

  9. BUSINESS DEVELOPMENT STRATEGY FOR SPECIALTY COFFEE

    Directory of Open Access Journals (Sweden)

    Vharessa Aknesia

    2015-01-01

    Full Text Available Specialty coffee is a coffee of premium quality that has been made through various stages of post-harvest processing and strictly controlled to produce distinctive taste of origins. PT Sinar Mayang Lestari is one of the companies that currently produce and develop specialty coffee type, Arabica Java Preanger. The objectives of the study are to examine competitive advantages and develop an alternative strategy that need to be done by PT Sinar Mayang Lestari for their business development. The research methods used are value chain analysis and VRIO framework to explore competitive advantage owned by the company. The result shows the company currently has a temporary competitive advantage of the technological resources and reputation. By using SWOT-AHP technique, the alternative strategies that can be done by company are as follows: 1 increasing the production of natural and honey coffee  type; 2 building coffee center in plantation site for sharing knowledge and innovation media to the farmers; 3 improving the competency of human resource in plantation, post harvest, and promoting area; 4 building management system gradually 5 forwarding integration by building roast and ground coffee business; and 6 maximizing the ability of the land and human resources through research and development.Keywords: competitive advantage, specialty coffee, SWOT-AHP, value chain, VRIOABSTRAKKopi special merupakan kopi dengan kualitas premium yang sudah melalui berbagai tahapan pengolahan pascapanen yang diawasi dengan ketat sehingga menghasilkan cita rasa yang khas sesuai dengan daerah asalnya. PT Sinar Mayang Lestari adalah salah satu perusahaan yang saatini memproduksi dan mengembangkan kopi spesial jenis Arabika Java Preanger. Tujuan dari penelitian ini adalah menganalisis keunggulan bersaing yang dimiliki dan mengembangkan alternative strategi yang perlu dilakukanoleh PT Sinar Mayang Lestari untuk pengembangan usahanya. Penelitian ini menggunakan analisis rantai

  10. Dentistry's oldest specialty: orthodontics and dentofacial orthopedics.

    Science.gov (United States)

    George, Raymond

    2009-01-01

    The American Association of Orthodontists (AAO) has 15,500 members worldwide and is the oldest and largest of the recognized dental specialties. A strategic planning process has identified six key challenges, and this article describes the progress that is being made in the areas of (a) consumer education, (b) volunteer leadership development, (c) recruitment and retention of orthodontic educators, (d) relationships with ADA and other healthcare organizations, (e) the AAO's role in international orthodontics, and (f) advocacy. The AAO is working for freedom of choice in dental healthcare providers; fee-for-service dental care; orthodontic insurance coverage as a benefit of employment, with direct reimbursement as the preferred plan; self-referred access to specialists; private and public funding that promote quality orthodontic care; and the retention of tax deductibility of dental healthcare benefits, including orthodontic care.

  11. Manufacturing Amorphous Solid Dispersions with a Tailored Amount of Crystallized API for Biopharmaceutical Testing.

    Science.gov (United States)

    Theil, Frank; Milsmann, Johanna; Anantharaman, Sankaran; van Lishaut, Holger

    2018-05-07

    The preparation of an amorphous solid dispersion (ASD) by dissolving a poorly water-soluble active pharmaceutical ingredient (API) in a polymer matrix can improve the bioavailability by orders of magnitude. Crystallization of the API in the ASD, though, is an inherent threat for bioavailability. Commonly, the impact of crystalline API on the drug release of the dosage form is studied with samples containing spiked crystallinity. These spiked samples possess implicit differences compared to native crystalline samples, regarding size and spatial distribution of the crystals as well as their molecular environment. In this study, we demonstrate that it is possible to grow defined amounts of crystalline API in solid dosage forms, which enables us to study the biopharmaceutical impact of actual crystallization. For this purpose, we studied the crystal growth in fenofibrate tablets over time under an elevated moisture using transmission Raman spectroscopy (TRS). As a nondestructive method to assess API crystallinity in ASD formulations, TRS enables the monitoring of crystal growth in individual dosage forms. Once the kinetic trace of the crystal growth for a certain environmental condition is determined, this method can be used to produce samples with defined amounts of crystallized API. To investigate the biopharmaceutical impact of crystallized API, non-QC dissolution methods were used, designed to identify differences between the various amounts of crystalline materials present. The drug release in the samples manufactured in this fashion was compared to that of samples with spiked crystallinity. In this study, we present for the first time a method for targeted crystallization of amorphous tablets to simulate crystallized ASDs. This methodology is a valuable tool to generate model systems for biopharmaceutical studies on the impact of crystallinity on the bioavailability.

  12. Study on Biopharmaceutics Classification and Oral Bioavailability of a Novel Multikinase Inhibitor NCE for Cancer Therapy

    Directory of Open Access Journals (Sweden)

    Yang Yang

    2014-04-01

    Full Text Available Specific biopharmaceutics classification investigation and study on phamacokinetic profile of a novel drug candidate (2-methylcarbamoyl-4-{4-[3- (trifluoromethyl benzamido] phenoxy} pyridinium 4-methylbenzenesulfonate monohydrate, NCE were carried out. Equilibrium solubility and intrinsic dissolution rate (IDR of NCE were estimated in different phosphate buffers. Effective intestinal permeability (Peff of NCE was determined using single-pass intestinal perfusion technique in rat duodenum, jejunum and ileum at three concentrations. Theophylline (high permeability and ranitidine (low permeability were also applied to access the permeability of NCE as reference compounds. The bioavailability after intragastrical and intravenous administration was measured in beagle dogs. The solubility of NCE in tested phosphate buffers was quite low with the maximum solubility of 81.73 μg/mL at pH 1.0. The intrinsic dissolution ratio of NCE was 1 × 10−4 mg·min−1·cm−2. The Peff value of NCE in all intestinal segments was more proximate to the high-permeability reference theophylline. Therefore, NCE was classified as class II drug according to Biopharmaceutics Classification System due to its low solubility and high intestinal permeability. In addition, concentration-dependent permeability was not observed in all the segments, indicating that there might be passive transportation for NCE. The absolute oral bioavailability of NCE in beagle dogs was 26.75%. Therefore, dissolution promotion will be crucial for oral formulation development and intravenous administration route will also be suggested for further NCE formulation development. All the data would provide a reference for biopharmaceutics classification research of other novel drug candidates.

  13. Study on biopharmaceutics classification and oral bioavailability of a novel multikinase inhibitor NCE for cancer therapy.

    Science.gov (United States)

    Yang, Yang; Fan, Chun-Mei; He, Xuan; Ren, Ke; Zhang, Jin-Kun; He, Ying-Ju; Yu, Luo-Ting; Zhao, Ying-Lan; Gong, Chang-Yang; Zheng, Yu; Song, Xiang-Rong; Zeng, Jun

    2014-04-25

    Specific biopharmaceutics classification investigation and study on phamacokinetic profile of a novel drug candidate (2-methylcarbamoyl-4-{4-[3- (trifluoromethyl) benzamido] phenoxy} pyridinium 4-methylbenzenesulfonate monohydrate, NCE) were carried out. Equilibrium solubility and intrinsic dissolution rate (IDR) of NCE were estimated in different phosphate buffers. Effective intestinal permeability (P(eff)) of NCE was determined using single-pass intestinal perfusion technique in rat duodenum, jejunum and ileum at three concentrations. Theophylline (high permeability) and ranitidine (low permeability) were also applied to access the permeability of NCE as reference compounds. The bioavailability after intragastrical and intravenous administration was measured in beagle dogs. The solubility of NCE in tested phosphate buffers was quite low with the maximum solubility of 81.73 μg/mL at pH 1.0. The intrinsic dissolution ratio of NCE was 1 × 10⁻⁴ mg·min⁻¹·cm⁻². The P(eff) value of NCE in all intestinal segments was more proximate to the high-permeability reference theophylline. Therefore, NCE was classified as class II drug according to Biopharmaceutics Classification System due to its low solubility and high intestinal permeability. In addition, concentration-dependent permeability was not observed in all the segments, indicating that there might be passive transportation for NCE. The absolute oral bioavailability of NCE in beagle dogs was 26.75%. Therefore, dissolution promotion will be crucial for oral formulation development and intravenous administration route will also be suggested for further NCE formulation development. All the data would provide a reference for biopharmaceutics classification research of other novel drug candidates.

  14. Assessing the Inventiveness of Bio-Pharmaceuticals under European and US Patent Law

    DEFF Research Database (Denmark)

    Minssen, Timo

    , is utterly wrong, since any DNA and the information it contains is the embodiment of the code of life and should be regarded part of the common heritage of mankind. Some patent opponents go even further and argue for a prohibition of patents on proteins. Others, and in particular the life science industry...... specifically, it investigates how the European and US patent systems interpret and apply the so called "inventive step" (Europe) or "non-obviousness" requirement (U.S.) vis-à-vis bio-pharmaceutical technology with a special emphasis on DNA-and protein related inventions. In addition to evaluating the de lata...

  15. Gendered Perceptions of Typical Engineers across Specialties for Engineering Majors

    Science.gov (United States)

    Kelley, Margaret S.; Bryan, Kimberley K.

    2018-01-01

    Young women do not choose to be engineers nearly as often as young men, and they tend to cluster in particular specialties when they do. We examine these patterns and the role of gender schemas as applied to perceptions of typical engineers in understanding the choices that women make in terms of engineering specialties. We use Part 1 of two waves…

  16. 75 FR 42431 - Onyx Specialty Papers, Inc; Notice Soliciting Applications

    Science.gov (United States)

    2010-07-21

    ... Papers, Inc; Notice Soliciting Applications July 14, 2010. On April 29, 2009, Onyx Specialty Papers, Inc... is located in the basement of MeadWestvaco's paper mill. There are no transmission lines associated... information from the licensee, please contact Mr. John Clements, Counsel for Onyx Specialty Papers, Inc., Van...

  17. Gender bias in specialty preferences among Danish medical students

    DEFF Research Database (Denmark)

    Pedersen, Laura Erna Toftegaard; Skytte, Nanna Hasle Bak; Dissing, Agnete Skovlund

    2011-01-01

    Female medical students tend to prefer person-oriented specialties characterized by close doctor-patient contact and aspects of care. Conversely, male medical students tend to seek towards specialties with elements of autonomy, technology and "action" . Furthermore, female doctors will outnumber ...

  18. The Orientation and Development of the Public Affair Management Specialty

    Science.gov (United States)

    Li, Chenghui; Fu, Yongxian; Chen, Rongxiang; Hu, Xueqi

    2010-01-01

    Though the specialty of the public affair management has been developed for ten years, but it is still facing the actuality that the orientation and development are difficult. Only by confirming the cultivation target and the development orientation, the development of the specialty could find the development approach and method. According to the…

  19. Integration of specialties: An institutional and organizational view.

    Science.gov (United States)

    Gerson, Elihu M

    2013-12-01

    By what mechanisms of organizational and institutional change do different specialties succeed in accommodating and working with one another? How do these mechanisms function over time to support and retard the emergence and stability of new knowledge? This paper considers two such mechanisms, metawork (work that determines the organization of work) and common knowledge (knowledge that participants know is known by all participants). These mechanisms integrate specialties by making the activities of multiple specialties dependent upon one another, and by segmenting the common effort from the parent specialties. Integration of specialties can lead to the development of new specialties. Integration is facilitated and impeded by the anchoring of specialties in the system of institutions that participate in research. Host organizations, degree programs, sponsors, associations, regulators, and other organizations provide resources and impose demands that shape research. Some of these impacts are obvious and direct; others are indirect and more subtle. The research specialties form a network (not a hierarchy) in which connections constantly form and reform, and in which the influence of different anchoring institutions are constantly waxing and waning. The complexity of connections and their pattern of change are especially obvious in the life sciences, which are an especially good place to study problems of integration. Copyright © 2012 Elsevier Ltd. All rights reserved.

  20. Medical costs, Cesarean delivery rates, and length of stay in specialty hospitals vs. non-specialty hospitals in South Korea.

    Directory of Open Access Journals (Sweden)

    Seung Ju Kim

    Full Text Available Since 2011, specialty hospitals in South Korea have been known for providing high- quality care in specific clinical areas. Much research related to specialty hospitals and their performance in many such areas has been performed, but investigations about their performance in obstetrics and gynecology are lacking. Thus, we aimed to compare specialty vs. non-specialty hospitals with respect to mode of obstetric delivery, especially the costs and length of stay related to Cesarean section (CS procedures, and to provide evidence to policy-makers for evaluating the success of hospitals that specialize in obstetric and gynecological (OBGYN care.We obtained National Health Insurance claim data from 2012 to 2014, which included information from 418,141 OBGYN cases at 214 hospitals. We used a generalized estimating equation model to identify a potential association between the likelihood of CS at specialty hospitals compared with other hospitals. We also evaluated medical costs and length of stay in specialty hospitals according to type of delivery.We found that 150,256 (35.9% total deliveries were performed by CS. The odds ratio of CS was significantly lower in specialty hospitals (OR: 0.95, 95% CI: 0.93-0.96compared to other hospitals Medical costs (0.74% and length of stay (1% in CS cases increased in specialty hospitals, although length of stay following vaginal delivery was lower (0.57% in specialty hospitals compared with other hospitals.We determined that specialty hospitals are significantly associated with a lower likelihood of CS delivery and shorter length of stay after vaginal delivery. Although they are also associated with higher costs for delivery, the increased cost could be due to the high level of intensive care provided, which leads to improve quality of care. Policy-makers should consider incentive programs to maintain performance of specialty hospitals and promote efficiency that could reduce medical costs accrued by patients.

  1. Hydrogen deuterium exchange mass spectrometry in biopharmaceutical discovery and development – A review

    Energy Technology Data Exchange (ETDEWEB)

    Deng, Bin, E-mail: dengbin@yorku.ca [Chemistry Department, York University, 4700 Keele Street, Toronto, ON, M3J 1P3 (Canada); The Centre for Research in Mass Spectrometry, York University, Toronto, ON, M3J1P3 (Canada); Lento, Cristina, E-mail: clento@yorku.ca [Chemistry Department, York University, 4700 Keele Street, Toronto, ON, M3J 1P3 (Canada); The Centre for Research in Mass Spectrometry, York University, Toronto, ON, M3J1P3 (Canada); Wilson, Derek J., E-mail: dkwilson@yorku.ca [Chemistry Department, York University, 4700 Keele Street, Toronto, ON, M3J 1P3 (Canada); The Centre for Research in Mass Spectrometry, York University, Toronto, ON, M3J1P3 (Canada)

    2016-10-12

    Protein therapeutics have emerged as a major class of biopharmaceuticals over the past several decades, a trend that has motivated the advancement of bioanalytical technologies for protein therapeutic characterization. Hydrogen deuterium exchange mass spectrometry (HDX-MS) is a powerful and sensitive technique that can probe the higher order structure of proteins and has been used in the assessment and development of monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs) and biosimilar antibodies. It has also been used to quantify protein-ligand, protein-receptor and other protein-protein interactions involved in signaling pathways. In manufacturing and development, HDX-MS can validate storage formulations and manufacturing processes for various biotherapeutics. Currently, HDX-MS is being refined to provide additional coverage, sensitivity and structural specificity and implemented on the millisecond timescale to reveal residual structure and dynamics in disordered domains and intrinsically disordered proteins. - Highlights: • The pharmaceuticals industry is increasingly shifting to protein therapeutics. • Hydrogen deuterium exchange mass spectrometry is uniquely well suited to support biopharmaceutical development. • Applications for hydrogen deuterium exchange span drug discovery, development and manufacturing. • Future developments will allow improved sensitivity, structural resolution and a broader range of dynamics to be monitored.

  2. Advances in industrial biopharmaceutical batch process monitoring: Machine-learning methods for small data problems.

    Science.gov (United States)

    Tulsyan, Aditya; Garvin, Christopher; Ündey, Cenk

    2018-04-06

    Biopharmaceutical manufacturing comprises of multiple distinct processing steps that require effective and efficient monitoring of many variables simultaneously in real-time. The state-of-the-art real-time multivariate statistical batch process monitoring (BPM) platforms have been in use in recent years to ensure comprehensive monitoring is in place as a complementary tool for continued process verification to detect weak signals. This article addresses a longstanding, industry-wide problem in BPM, referred to as the "Low-N" problem, wherein a product has a limited production history. The current best industrial practice to address the Low-N problem is to switch from a multivariate to a univariate BPM, until sufficient product history is available to build and deploy a multivariate BPM platform. Every batch run without a robust multivariate BPM platform poses risk of not detecting potential weak signals developing in the process that might have an impact on process and product performance. In this article, we propose an approach to solve the Low-N problem by generating an arbitrarily large number of in silico batches through a combination of hardware exploitation and machine-learning methods. To the best of authors' knowledge, this is the first article to provide a solution to the Low-N problem in biopharmaceutical manufacturing using machine-learning methods. Several industrial case studies from bulk drug substance manufacturing are presented to demonstrate the efficacy of the proposed approach for BPM under various Low-N scenarios. © 2018 Wiley Periodicals, Inc.

  3. Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing.

    Science.gov (United States)

    Jiang, Mo; Severson, Kristen A; Love, John Christopher; Madden, Helena; Swann, Patrick; Zang, Li; Braatz, Richard D

    2017-11-01

    Real-time release testing (RTRT) is defined as "the ability to evaluate and ensure the quality of in-process and/or final drug product based on process data, which typically includes a valid combination of measured material attributes and process controls" (ICH Q8[R2]). This article discusses sensors (process analytical technology, PAT) and control strategies that enable RTRT for the spectrum of critical quality attributes (CQAs) in biopharmaceutical manufacturing. Case studies from the small-molecule and biologic pharmaceutical industry are described to demonstrate how RTRT can be facilitated by integrated manufacturing and multivariable control strategies to ensure the quality of products. RTRT can enable increased assurance of product safety, efficacy, and quality-with improved productivity including faster release and potentially decreased costs-all of which improve the value to patients. To implement a complete RTRT solution, biologic drug manufacturers need to consider the special attributes of their industry, particularly sterility and the measurement of viral and microbial contamination. Continued advances in on-line and in-line sensor technologies are key for the biopharmaceutical manufacturing industry to achieve the potential of RTRT. Related article: http://onlinelibrary.wiley.com/doi/10.1002/bit.26378/full. © 2017 Wiley Periodicals, Inc.

  4. Hydrogen deuterium exchange mass spectrometry in biopharmaceutical discovery and development – A review

    International Nuclear Information System (INIS)

    Deng, Bin; Lento, Cristina; Wilson, Derek J.

    2016-01-01

    Protein therapeutics have emerged as a major class of biopharmaceuticals over the past several decades, a trend that has motivated the advancement of bioanalytical technologies for protein therapeutic characterization. Hydrogen deuterium exchange mass spectrometry (HDX-MS) is a powerful and sensitive technique that can probe the higher order structure of proteins and has been used in the assessment and development of monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs) and biosimilar antibodies. It has also been used to quantify protein-ligand, protein-receptor and other protein-protein interactions involved in signaling pathways. In manufacturing and development, HDX-MS can validate storage formulations and manufacturing processes for various biotherapeutics. Currently, HDX-MS is being refined to provide additional coverage, sensitivity and structural specificity and implemented on the millisecond timescale to reveal residual structure and dynamics in disordered domains and intrinsically disordered proteins. - Highlights: • The pharmaceuticals industry is increasingly shifting to protein therapeutics. • Hydrogen deuterium exchange mass spectrometry is uniquely well suited to support biopharmaceutical development. • Applications for hydrogen deuterium exchange span drug discovery, development and manufacturing. • Future developments will allow improved sensitivity, structural resolution and a broader range of dynamics to be monitored.

  5. Novel approaches to vaginal delivery and safety of microbicides: biopharmaceuticals, nanoparticles, and vaccines.

    Science.gov (United States)

    Whaley, Kevin J; Hanes, Justin; Shattock, Robin; Cone, Richard A; Friend, David R

    2010-12-01

    The HIV-1 epidemic remains unchecked despite existing technology; vaccines and microbicides in development may help reverse the epidemic. Reverse transcriptase inhibitors (RTIs) formulated in gels tenofovir (TFV) and IVRs (dapivirine) are under clinical development. While TFV or similar products may prove successful for HIV-1, alternatives to RTIs may provide additional benefits, e.g., broader STI prevention. Biopharmaceutical agents under development as microbicides include cyanovirin, RANTES analogues, commensals, and Mabs. Cost of manufacturing biopharmaceuticals has been reduced and they can be formulated into tablets, films, and IVRs for vaginal delivery. Nanotechnology offers a novel approach to formulate microbicides potentially leading to uniform epithelial delivery. Delivery through vaginal mucus may be possible by controlling nanoparticle size and surface characteristics. Combining prevention modalities may be the most effective means of preventing STI transmission, importantly, codelivery of microbicides and vaccines has demonstrated. Finally, the safety of microbicide preparations and excipients commonly used can be assessed using a mouse/HSV-2 susceptibility model. Screening of new microbicide candidates and formulation excipients may avoid past issues of enhancing HIV-1 transmission. This article forms part of a special supplement covering several presentations on novel microbicide formulations from the symposium on "Recent Trends in Microbicide Formulations" held on 25 and 26 January 2010, Arlington, VA. Copyright © 2010 Elsevier B.V. All rights reserved.

  6. Characterization of systems with amino-acids and oligosaccharides as modifiers of biopharmaceutical properties of furosemide.

    Science.gov (United States)

    Miranda, Julieta Abraham; Garnero, Claudia; Zoppi, Ariana; Sterren, Vanesa; Ayala, Alejandro P; Longhi, Marcela R

    2018-02-05

    Furosemide is the most commonly prescribed diuretic drug in spite of its suboptimal biopharmaceutical properties. In this work, the addition of different amino-acids was studied with the aim of selecting an enhancer of the furosemide solubility. The best results were obtained with arginine. Also, binary (furosemide:arginine) and ternary (furosemide:arginine:β-cyclodextrin and furosemide:arginine:maltodextrin) systems were prepared by the kneading method and they were compared with their corresponding physical mixtures. These new systems were characterized by Fourier transform infrared and Raman spectroscopy, X-ray powder diffractometry, scanning electron microscopy, thermogravimetric analysis, and differential scanning calorimetry. In addition, dissolution studies were performed in simulated gastric fluid. The best results in relation to improving biopharmaceutical properties were obtained with a binary combination of furosemide and arginine, demonstrating that this system could result in a suitable candidate for the development of a promising pharmaceutical formulation of the drug. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Impact of Magnetic Stirring on Stainless Steel Integrity: Effect on Biopharmaceutical Processing.

    Science.gov (United States)

    Thompson, Christopher; Wilson, Kelly; Kim, Yoen Joo; Xie, Min; Wang, William K; Wendeler, Michaela

    2017-11-01

    Stainless steel containers are widely used in the pharmaceutical and biopharmaceutical industry for the storage of buffers, process intermediates, and purified drug substance. They are generally held to be corrosion resistant, biocompatible, and nonreactive, although it is well established that trace amounts of metal ions can leach from stainless steel equipment into biopharmaceutical products. We report here that the use of stainless steel containers in conjunction with magnetic stirring bars leads to significantly aggravated metal contamination, consisting of both metal particles and significantly elevated metal ions in solution, the degree of which is several orders of magnitude higher than described for static conditions. Metal particles are analyzed by scanning electron microscopy with electron-dispersive X-ray spectroscopy, and metal content in solution is quantitated at different time points by inductively coupled plasma-mass spectrometry. The concentration of iron, chromium, nickel, and manganese increases with increasing stirring time and speed. We describe the impact of buffer components on the extent of metal particles and ions in solution and illustrate the effect on model proteins. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  8. Characterization of Protein-Excipient Microheterogeneity in Biopharmaceutical Solid-State Formulations by Confocal Fluorescence Microscopy.

    Science.gov (United States)

    Koshari, Stijn H S; Ross, Jean L; Nayak, Purnendu K; Zarraga, Isidro E; Rajagopal, Karthikan; Wagner, Norman J; Lenhoff, Abraham M

    2017-02-06

    Protein-stabilizer microheterogeneity is believed to influence long-term protein stability in solid-state biopharmaceutical formulations and its characterization is therefore essential for the rational design of stable formulations. However, the spatial distribution of the protein and the stabilizer in a solid-state formulation is, in general, difficult to characterize because of the lack of a functional, simple, and reliable characterization technique. We demonstrate the use of confocal fluorescence microscopy with fluorescently labeled monoclonal antibodies (mAbs) and antibody fragments (Fabs) to directly visualize three-dimensional particle morphologies and protein distributions in dried biopharmaceutical formulations, without restrictions on processing conditions or the need for extensive data analysis. While industrially relevant lyophilization procedures of a model IgG1 mAb generally lead to uniform protein-excipient distribution, the method shows that specific spray-drying conditions lead to distinct protein-excipient segregation. Therefore, this method can enable more definitive optimization of formulation conditions than has previously been possible.

  9. Considerations for a Pediatric Biopharmaceutics Classification System (BCS): application to five drugs.

    Science.gov (United States)

    Gandhi, Shivani V; Rodriguez, William; Khan, Mansoor; Polli, James E

    2014-06-01

    It has been advocated that biopharmaceutic risk assessment should be conducted early in pediatric product development and synchronized with the adult product development program. However, we are unaware of efforts to classify drugs into a Biopharmaceutics Classification System (BCS) framework for pediatric patients. The objective was to classify five drugs into a potential BCS. These five drugs were selected since both oral and intravenous pharmacokinetic data were available for each drug, and covered the four BCS classes in adults. Literature searches for each drug were conducted using Medline and applied to classify drugs with respect to solubility and permeability in pediatric subpopulations. Four pediatric subpopulations were considered: neonates, infants, children, and adolescents. Regarding solubility, dose numbers were calculated using a volume for each subpopulation based on body surface area (BSA) relative to 250 ml for a 1.73 m(2) adult. Dose numbers spanned a range of values, depending upon the pediatric dose formula and subpopulation. Regarding permeability, pharmacokinetic literature data required assumptions and decisions about data collection. Using a devised pediatric BCS framework, there was agreement in adult and pediatric BCS class for two drugs, azithromycin (class 3) and ciprofloxacin (class 4). There was discordance for the three drugs that have high adult permeability since all pediatric permeabilities were low: dolasetron (class 3 in pediatric), ketoprofen (class 4 in pediatric), and voriconazole (class 4 in pediatric). A main contribution of this work is the identification of critical factors required for a pediatric BCS.

  10. A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design.

    Science.gov (United States)

    Martin-Moe, Sheryl; Lim, Fredric J; Wong, Rita L; Sreedhara, Alavattam; Sundaram, Jagannathan; Sane, Samir U

    2011-08-01

    Quality by design (QbD) is a science- and risk-based approach to drug product development. Although pharmaceutical companies have historically used many of the same principles during development, this knowledge was not always formally captured or proactively submitted to regulators. In recent years, the US Food and Drug Administration has also recognized the need for more controls in the drug manufacturing processes, especially for biological therapeutics, and it has recently launched an initiative for Pharmaceutical Quality for the 21st Century to modernize pharmaceutical manufacturing and improve product quality. In the biopharmaceutical world, the QbD efforts have been mainly focused on active pharmaceutical ingredient processes with little emphasis on drug product development. We present a systematic approach to biopharmaceutical drug product development using a monoclonal antibody as an example. The approach presented herein leverages scientific understanding of products and processes, risk assessments, and rational experimental design to deliver processes that are consistent with QbD philosophy without excessive incremental effort. Data generated using these approaches will not only strengthen data packages to support specifications and manufacturing ranges but hopefully simplify implementation of postapproval changes. We anticipate that this approach will positively impact cost for companies, regulatory agencies, and patients, alike. Copyright © 2011 Wiley-Liss, Inc.

  11. Physician wages across specialties: informing the physician reimbursement debate.

    Science.gov (United States)

    Leigh, J Paul; Tancredi, Daniel; Jerant, Anthony; Kravitz, Richard L

    2010-10-25

    Disparities in remuneration between primary care and other physician specialties may impede health care reform by undermining the sustainability of a primary care workforce. Previous studies have compared annual incomes across specialties unadjusted for work hours. Wage (earnings-per-hour) comparisons could better inform the physician payment debate. In a cross-sectional analysis of data from 6381 physicians providing patient care in the 2004-2005 Community Tracking Study (adjusted response rate, 53%), we compared wages across broad and narrow categories of physician specialties. Tobit and linear regressions were run. Four broad specialty categories (primary care, surgery, internal medicine and pediatric subspecialties, and other) and 41 specific specialties were analyzed together with demographic, geographic, and market variables. In adjusted analyses on broad categories, wages for surgery, internal medicine and pediatric subspecialties, and other specialties were 48%, 36%, and 45% higher, respectively, than for primary care specialties. In adjusted analyses for 41 specific specialties, wages were significantly lower for the following than for the reference group of general surgery (wage near median, $85.98): internal medicine and pediatrics combined (-$24.36), internal medicine (-$24.27), family medicine (-$23.70), and other pediatric subspecialties (-$23.44). Wage rankings were largely impervious to adjustment for control variables, including age, race, sex, and region. Wages varied substantially across physician specialties and were lowest for primary care specialties. The primary care wage gap was likely conservative owing to exclusion of radiologists, anesthesiologists, and pathologists. In light of low and declining medical student interest in primary care, these findings suggest the need for payment reform aimed at increasing incomes or reducing work hours for primary care physicians.

  12. Commercial production of specialty chemicals and pharmaceuticals from biomass

    Energy Technology Data Exchange (ETDEWEB)

    McChesney, J.D. [Univ. of Mississippi, University, MS (United States)

    1993-12-31

    The chemical substances utilized in consumer products, and for pharmaceutical and agricultural uses are generally referred to as specialty chemicals. These may be flavor or fragrance substances, intermediates for synthesis of drugs or agrochemicals or the drugs or agrochemicals themselves, insecticides or insect pheromones or antifeedants, plant growth regulators, etc. These are in contrast to chemicals which are utilized in large quantities for fuels or preparation of plastics, lubricants, etc., which are usually referred to as industrial chemicals. The specific utilization of specialty chemicals is associated with a specific important physiochemical or biological property. They may possess unique properties as lubricants or waxes or have a very desirable biological activity such as a drug, agrochemical or perfume ingredient. These unique properties convey significant economic value to the specific specialty chemical. The economic commercial production of specialty chemicals commonly requires the isolation of a precursor or the specialty chemical itself from a natural source. The discovery, development and commercialization of specialty chemicals is presented and reviewed. The economic and sustainable production of specialty chemicals is discussed.

  13. Collaboration between paediatric surgery and other medical specialties in Nigeria

    Directory of Open Access Journals (Sweden)

    Philemon E Okoro

    2012-01-01

    Full Text Available Background: The quality of service and success of patient care and research in most fields of medicine depend on effective collaboration between different specialties. Paediatric surgery is a relatively young specialty in Nigeria and such collaborations are desirable. This survey assesses the nature and extent of collaboration between paediatric surgery and other specialties in Nigeria. Materials and Methods: This is a questionnaire survey carried out in November 2008 among paediatric surgeons and their trainees practising in Nigeria. Questionnaires were distributed and retrieved either by hand or e-mailing. The responses were then collated and analysed using the SPSS 17.0. Results: Forty-seven respondents were included in the survey. Forty-five (95.7% respondents thought that there was inadequate collaboration and that there was a need for an increased collaboration between paediatric surgery and other specialties. Anaesthesia, paediatrics and radiology are among the specialties where collaborations were most required but not adequately received. Collaboration had been required from these specialties in areas of patient care, training and research. Reasons for inadequate collaboration included the paucity of avenues for inter-specialty communication and exchange of ideas 33 (70.3%, lack of awareness of the need for collaboration 32 (68.1%, tendency to apportion blames for bad outcome 13 (27.7%, and mutual suspicion 8 (17%. Conclusion: There is presently inadequate collaboration between paediatric surgery and other specialties in Nigeria. There is a need for more inter-specialty support, communication, and exchange of ideas in order to achieve desirable outcomes.

  14. Personality traits and career choices among physicians in Finland: employment sector, clinical patient contact, specialty and change of specialty.

    Science.gov (United States)

    Mullola, Sari; Hakulinen, Christian; Presseau, Justin; Gimeno Ruiz de Porras, David; Jokela, Markus; Hintsa, Taina; Elovainio, Marko

    2018-03-27

    Personality influences an individual's adaptation to a specific job or organization. Little is known about personality trait differences between medical career and specialty choices after graduating from medical school when actually practicing different medical specialties. Moreover, whether personality traits contribute to important career choices such as choosing to work in the private or public sector or with clinical patient contact, as well as change of specialty, have remained largely unexplored. In a nationally representative sample of Finnish physicians (N = 2837) we examined how personality traits are associated with medical career choices after graduating from medical school, in terms of employment sector, patient contact, medical specialty and change of specialty. Personality was assessed using the shortened version of the Big Five Inventory (S-BFI). An analysis of covariance with posthoc tests for pairwise comparisons was conducted, adjusted for gender and age with confounders (employment sector, clinical patient contact and medical specialty). Higher openness was associated with working in the private sector, specializing in psychiatry, changing specialty and not practicing with patients. Lower openness was associated with a high amount of patient contact and specializing in general practice as well as ophthalmology and otorhinolaryngology. Higher conscientiousness was associated with a high amount of patient contact and specializing in surgery and other internal medicine specialties. Lower conscientiousness was associated with specializing in psychiatry and hospital service specialties. Higher agreeableness was associated with working in the private sector and specializing in general practice and occupational health. Lower agreeableness and neuroticism were associated with specializing in surgery. Higher extraversion was associated with specializing in pediatrics and change of specialty. Lower extraversion was associated with not practicing with

  15. 75 FR 39664 - Grant of Authority For Subzone Status Materials Science Technology, Inc. (Specialty Elastomers...

    Science.gov (United States)

    2010-07-12

    ... Status Materials Science Technology, Inc. (Specialty Elastomers and Fire Retardant Chemicals) Conroe... specialty elastomer manufacturing and distribution facility of Materials Science Technology, Inc., located... and distribution of specialty elastomers and fire retardant chemicals at the facility of Materials...

  16. Association of medical student burnout with residency specialty choice.

    Science.gov (United States)

    Enoch, Lindsey; Chibnall, John T; Schindler, Debra L; Slavin, Stuart J

    2013-02-01

    Given the trend among medical students away from primary care medicine and toward specialties that allow for more controllable lifestyles, the identification of factors associated with specialty choice is important. Burnout is one such factor. The purpose of this study was to examine the associations between burnout and residency specialty choice in terms of provision for a less versus more controllable lifestyle (e.g. internal medicine versus dermatology) and a lower versus higher income (e.g. paediatrics versus anaesthesiology). A survey was sent to 165 Year 4 medical students who had entered the residency matching system. Students answered questions about specialty choice, motivating factors (lifestyle, patient care and prestige) and perceptions of medicine as a profession. They completed the Maslach Burnout Inventory-Human Services (MBI), which defines burnout in relation to emotional exhaustion (EE), depersonalisation (DP) and personal accomplishment (PA). Burnout and other variables were tested for associations with specialty lifestyle controllability and income. A response rate of 88% (n = 145) was achieved. Experiences of MBI-EE, MBI-DP and MBI-PA burnout were reported by 42 (29%), 26 (18%) and 30 (21%) students, respectively. Specialties with less controllable lifestyles were chosen by 87 (60%) students and lower-income specialties by 81 (56%). Adjusted odds ratios (ORs) indicated that the choice of a specialty with a more controllable lifestyle was associated with higher MBI-EE burnout (OR = 1.77, 95% confidence interval [CI] 1.06-2.96), as well as stronger lifestyle- and prestige-related motivation, and weaker patient care-related motivation. The choice of a higher-income specialty was associated with lower MBI-PA burnout (OR = 0.56, 95% CI 0.32-0.98), weaker lifestyle- and patient care-related motivation, and stronger prestige-related motivation. Specialty choices regarding lifestyle controllability and income were associated with the amount and type of

  17. Two interesting cases highlighting an oblivious specialty of psychoneuroendocrinology.

    Science.gov (United States)

    Hari Kumar, K V S; Dhull, Pawan; Somasekharan, Manoj; Seshadri, K

    2012-01-01

    Psychoneuroendocrinology deals with the overlap disorders pertaining to three different specialties. Awareness about the somatic manifestations of psychiatric diseases and vice versa is a must for all the clinicians. The knowledge of this interlinked specialty is essential because of the obscure presentation of certain disorders. Our first case was treated as depressive disorder, whereas the diagnosis was hypogonadism with empty sella. Our second patient was managed as schizophrenia and the evaluation revealed bilateral basal ganglia calcification and a diagnosis of Fahr's disease. We report these cases for their unusual presentation and to highlight the importance of this emerging specialty.

  18. Accumulation of organic compounds leached from plastic materials used in biopharmaceutical process containers.

    Science.gov (United States)

    Jenke, Dennis R; Zietlow, David; Garber, Mary Jo; Sadain, Salma; Reiber, Duane; Terbush, William

    2007-01-01

    Plastic materials are widely used in medical items, such as solution containers, transfusion sets, transfer tubing, and devices. An emerging trend in the biotechnology industry is the utilization of plastic containers to prepare, transport, and store an assortment of solutions including buffers, media, and in-process and finished product. The direct contact of such containers with the product at one or more points in its lifetime raises the possibility that container leachables may accumulate in the finished product. The interaction between several commercially available container materials and numerous model test solutions (representative of buffers and media used in biopharmaceutical applications) was investigated. This paper summarizes the identification of leachables associated with the container materials and documents the levels to which targeted leachables accumulate in the test solutions under defined storage conditions.

  19. RFID sensors as the common sensing platform for single-use biopharmaceutical manufacturing

    International Nuclear Information System (INIS)

    Potyrailo, Radislav A; Surman, Cheryl; Monk, David; Morris, William G; Wortley, Timothy; Vincent, Mark; Diana, Rafael; Pizzi, Vincent; Carter, Jeffrey; Gach, Gerard; Klensmeden, Staffan; Ehring, Hanno

    2011-01-01

    The lack of reliable single-use sensors prevents the biopharmaceutical industry from fully embracing single-use biomanufacturing processes. Sensors based on the same detection platform for all critical parameters in single-use bioprocess components would be highly desirable to significantly simplify their installation, calibration and operation. We review here our approach for passive radio-frequency identification (RFID)-based sensing that does not rely on costly proprietary RFID memory chips with an analog input but rather implements ubiquitous passive 13.56 MHz RFID tags as inductively coupled sensors with at least 16 bit resolution provided by a sensor reader. The developed RFID sensors combine several measured parameters from the resonant sensor antenna with multivariate data analysis and deliver unique capability of multiparameter sensing and rejection of environmental interferences with a single sensor. This general sensing approach provides an elegant solution for both analytical measurement and identification and documentation of the measured location. (topical review)

  20. Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry.

    Science.gov (United States)

    Beck, Alain; Reichert, Janice M

    2013-01-01

    In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion's Remsima® and Hospira's Inflectra®), and recommended that they be approved for marketing in the European Union (EU). The European Commission's decision on an application is typically issued 67 d after an opinion is provided; thus, decisions are expected in early September 2013. If approved, the products will comprise the first biosimilar antibody made available to patients in a highly regulated market, although launch may be delayed due to an extension of the reference product's (Remicade®) patent in the EU.

  1. Second International Conference on Accelerating Biopharmaceutical Development: March 9-12, 2009, Coronado, CA, USA.

    Science.gov (United States)

    Reichert, Janice M; Jacob, Nitya M; Amanullah, Ashraf

    2009-01-01

    The Second International Conference on Accelerating Biopharmaceutical Development was held in Coronado, California. The meeting was organized by the Society for Biological Engineering (SBE) and the American Institute of Chemical Engineers (AIChE); SBE is a technological community of the AIChE. Bob Adamson (Wyeth) and Chuck Goochee (Centocor) were co-chairs of the event, which had the theme "Delivering cost-effective, robust processes and methods quickly and efficiently." The first day focused on emerging disruptive technologies and cutting-edge analytical techniques. Day two featured presentations on accelerated cell culture process development, critical quality attributes, specifications and comparability, and high throughput protein formulation development. The final day was dedicated to discussion of technology options and new analysis methods provided by emerging disruptive technologies; functional interaction, integration and synergy in platform development; and rapid and economic purification process development.

  2. [Impacts of multicomponent environment on solubility of puerarin in biopharmaceutics classification system of Chinese materia medica].

    Science.gov (United States)

    Hou, Cheng-Bo; Wang, Guo-Peng; Zhang, Qiang; Yang, Wen-Ning; Lv, Bei-Ran; Wei, Li; Dong, Ling

    2014-12-01

    To illustrate the solubility involved in biopharmaceutics classification system of Chinese materia medica (CMMBCS) , the influences of artificial multicomponent environment on solubility were investigated in this study. Mathematical model was built to describe the variation trend of their influence on the solubility of puerarin. Carried out with progressive levels, single component environment: baicalin, berberine and glycyrrhizic acid; double-component environment: baicalin and glycyrrhizic acid, baicalin and berberine and glycyrrhizic acid and berberine; and treble-component environment: baicalin, berberin, glycyrrhizic acid were used to describe the variation tendency of their influences on the solubility of puerarin, respectively. And then, the mathematical regression equation model was established to characterize the solubility of puerarin under multicomponent environment.

  3. Pharmacokinetic and biopharmaceutic aspects of some psoralen derivatives used in dermatology

    International Nuclear Information System (INIS)

    Stolk, L.M.L.

    1982-01-01

    In the present thesis the pharmacokinetic and biopharmaceutic properties of some psoralen derivatives, that are used in photochemotherapy of dermatological diseases like vitiligo and psoriasis, are studied. Photochemotherapy is a combination of oral administration of one of the psoralen derivatives, 8-methoxypsoralen (8-MOP), 5-methoxypsoralen (5-MOP) or 4, 5', 8-trimethylpsoralen (TMP), and irradiation with long wave ultraviolet light, U.V.-A (320-400 nm), two hours later. This treatment is commonly called PUVA (Psoralen-UV-A). The purpose of the investigation was to develop an 8-MOP dosage form with a fast and reproducible absorption. Various dosage forms of 8-MOP were administered to volunteers and patients and 8-MOP concentrations in body fluids determined. Also the pharmacokinetic properties of 5-MOP and TMP were investigated in a pilot study. (Auth.)

  4. Cell-Penetrating Peptides as Carriers for Oral Delivery of Biopharmaceuticals

    DEFF Research Database (Denmark)

    Kristensen, Mie; Nielsen, Hanne Mørck

    2016-01-01

    Oral delivery of biopharmaceuticals, for example peptides and proteins, constitutes a great challenge in drug delivery due to their low chemical stability and poor permeation across the intestinal mucosa, to a large extent limiting the mode of administration to injections, which is not favouring...... patient compliance. Nevertheless, cell-penetrating peptides (CPPs) have shown promising potential as carriers to overcome the epithelium, and this minireview highlights recent knowledge gained within the field of CPP-mediated transepithelial delivery of therapeutic peptides and proteins from the intestine...... is to be preferred depends on the physicochemical properties of both the specific CPP and the specific cargo. In addition to the physical epithelial barrier, a metabolic barrier must be overcome in order to obtain CPP-mediated delivery of a cargo drug from the intestine, and a number of strategies have been employed...

  5. Future Choice of Specialty among Students in a Caribbean Medical ...

    African Journals Online (AJOL)

    Background: The medical specialities chosen by medical students for their careers play an important part in ... data, generic factors considered as important in their specialty choice as well as factors that influence the students\\' attractiveness to ...

  6. Awareness and perception of the specialty of family medicine ...

    African Journals Online (AJOL)

    Background: Family Medicine is the medical specialty that provides ... the World Health Organization (WHO) has acknowledged the critical importance and positive ... This study evaluated the awareness, knowledge and perception of Family ...

  7. 15 CFR 2011.204 - Entry of specialty sugars.

    Science.gov (United States)

    2010-01-01

    ... UNITED STATES TRADE REPRESENTATIVE ALLOCATION OF TARIFF-RATE QUOTA ON IMPORTED SUGARS, SYRUPS AND... present a certificate to the appropriate customs official at the date of entry of specialty sugars. Entry...

  8. Fiber Fabrication Facility for Non-Oxide and Specialty Glasses

    Data.gov (United States)

    Federal Laboratory Consortium — FUNCTION: Unique facility for the research, development, and fabrication of non-oxide and specialty glasses and fibers in support of Navy/DoD programs.DESCRIPTION:...

  9. Capacity Planning for Batch and Perfusion Bioprocesses Across Multiple Biopharmaceutical Facilities

    Science.gov (United States)

    Siganporia, Cyrus C; Ghosh, Soumitra; Daszkowski, Thomas; Papageorgiou, Lazaros G; Farid, Suzanne S

    2014-01-01

    Production planning for biopharmaceutical portfolios becomes more complex when products switch between fed-batch and continuous perfusion culture processes. This article describes the development of a discrete-time mixed integer linear programming (MILP) model to optimize capacity plans for multiple biopharmaceutical products, with either batch or perfusion bioprocesses, across multiple facilities to meet quarterly demands. The model comprised specific features to account for products with fed-batch or perfusion culture processes such as sequence-dependent changeover times, continuous culture constraints, and decoupled upstream and downstream operations that permit independent scheduling of each. Strategic inventory levels were accounted for by applying cost penalties when they were not met. A rolling time horizon methodology was utilized in conjunction with the MILP model and was shown to obtain solutions with greater optimality in less computational time than the full-scale model. The model was applied to an industrial case study to illustrate how the framework aids decisions regarding outsourcing capacity to third party manufacturers or building new facilities. The impact of variations on key parameters such as demand or titres on the optimal production plans and costs was captured. The analysis identified the critical ratio of in-house to contract manufacturing organization (CMO) manufacturing costs that led the optimization results to favor building a future facility over using a CMO. The tool predicted that if titres were higher than expected then the optimal solution would allocate more production to in-house facilities, where manufacturing costs were lower. Utilization graphs indicated when capacity expansion should be considered. © 2013 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers Biotechnol. Prog., 30:594–606, 2014 PMID:24376262

  10. Aspects of research and development contract terms in the bio/pharmaceutical sector.

    Science.gov (United States)

    Banerjee, Tannista

    2012-01-01

    The cost of new drug development is increasing every year. Pharmaceutical companies use R&D joint ventures, mergers, and outsource different stages of pharmaceutical R&D activities for a faster and cost minimizing method of innovation. Pharmaceutical companies outsource R&D activities to independent small biotech or pharmaceutical companies that specialize in different stages of pharmaceutical R&D. This chapter examines the determinants of the payment structure of research contracts between large bio/pharmaceutical companies and specialized research firms. Determinants of R&D contracts are analyzed using detailed R&D contract data between bio/pharmaceutical companies and independent research firms for 10 years. A multinomial logit model is used in order to understand the determinants of three different types of contracts; royalty contracts, fixed payment contracts, and the mixed contracts. Under uncertainty, the likelihood of a royalty contract rises for the early stages of the research and with the patent stock of the research firm. It is more likely to observe both royalty and fixed payment if the pharmaceutical client has past contracts with the same research firm. The results also suggest that if Food and Drug Administration (FDA) is more stringent in any disease area in reviewing the new drug application, then the likelihood of signing pure royalty contract decreases. Understanding the nature of R&D contracts and the effects of FDA's behavior on the pharmaceutical R&D contract is important because these contracts not only affect the cost of new drug invention but also the quality and the rate of invention. VALUE: Results are useful for both the pharmaceutical companies and the economic/business researchers.

  11. Biopharmaceutical characterization of praziquantel cocrystals and cyclodextrin complexes prepared by grinding.

    Science.gov (United States)

    Cugovčan, Martina; Jablan, Jasna; Lovrić, Jasmina; Cinčić, Dominik; Galić, Nives; Jug, Mario

    2017-04-15

    Mechanochemical activation using several different co-grinding additives was applied as a green chemistry approach to improve physiochemical and biopharmaceutical properties of praziquantel (PZQ). Liquid assisted grinding with an equimolar amount of citric acid (CA), malic acid (MA), salicylic acid (SA) and tartaric acid (TA) gained in cocrystal formation, which all showed pH-dependent solubility and dissolution rate. However, the most soluble cocrystal of PZQ with MA was chemically unstable, as seen during the stability testing. Equimolar cyclodextrin complexes prepared by neat grinding with amorphous hydroxypropyl-β-cyclodextrin (HPβCD) and randomly methylated β-cyclodextrin (MEβCD) showed the highest improvement in drug solubility and the dissolution rate, but only PZQ/HPβCD product presented an acceptable chemical and photostability profile. A combined approach, by co-grinding the drug with both MA and HPβCD in equimolar ratio, also gave highly soluble amorphous product which again was chemical instable and therefore not suitable for the pharmaceutical use. Studies on Caco-2 monolayer confirmed the biocompatibility of PZQ/HPβCD complex and showed that complexation did not adversely affect the intrinsically high PZQ permeability (P app (PZQ)=(3.72±0.33)×10 -5 cms -1 and P app (PZQ/HPβCD)=(3.65±0.21)×10 -5 cms -1 ; p>0.05). All this confirmed that the co-grinding with the proper additive is as a promising strategy to improve biopharmaceutical properties of the drug. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Endotoxin inactivation via steam-heat treatment in dilute simethicone emulsions used in biopharmaceutical processes.

    Science.gov (United States)

    Britt, Keith A; Galvin, Jeffrey; Gammell, Patrick; Nti-Gyabaah, Joseph; Boras, George; Kolwyck, David; Ramirez, José G; Presente, Esther; Naugle, Gregory

    2014-01-01

    Simethicone emulsion is used to regulate foaming in cell culture operations in biopharmaceutical processes. It is also a potential source of endotoxin contamination. The inactivation of endotoxins in dilute simethicone emulsions was assessed as a function of time at different steam temperatures using a Limulus amebocyte lysate kinetic chromogenic technique. Endotoxin inactivation from steam-heat treatment was fit to a four-parameter double exponential decay model, which indicated that endotoxin inactivation was biphasic, consisting of fast and slow regimes. In the fast regime, temperature-related effects were dominant. Transitioning into the slow regime, the observed temperature dependence diminished, and concentration-related effects became increasingly significant. The change in the Gibbs free energy moving through the transition state indicated that a large energy barrier must be overcome for endotoxin inactivation to occur. The corresponding Arrhenius pre-exponential factor was >10(12) s(-1) suggesting that endotoxins in aqueous solution exist as aggregates. The disorder associated with the endotoxin inactivation reaction pathway was assessed via the change in entropy moving through the transition state. This quantity was positive indicating that endotoxin inactivation may result from hydrolysis of individual endotoxin molecules, which perturbs the conformation of endotoxin aggregates, thereby modulating the biological activity observed. Steam-heat treatment decreased endotoxin levels by 1-2 logarithm (log) reduction (LRV), which may be practically relevant depending on incoming raw material endotoxin levels. Antifoam efficiency and cell culture performance were negligibly impacted following steam-heat treatment. The results from this study show that steam-heat treatment is a viable endotoxin control strategy that can be implemented to support large-scale biopharmaceutical manufacturing. © 2014 American Institute of Chemical Engineers.

  13. Capacity planning for batch and perfusion bioprocesses across multiple biopharmaceutical facilities.

    Science.gov (United States)

    Siganporia, Cyrus C; Ghosh, Soumitra; Daszkowski, Thomas; Papageorgiou, Lazaros G; Farid, Suzanne S

    2014-01-01

    Production planning for biopharmaceutical portfolios becomes more complex when products switch between fed-batch and continuous perfusion culture processes. This article describes the development of a discrete-time mixed integer linear programming (MILP) model to optimize capacity plans for multiple biopharmaceutical products, with either batch or perfusion bioprocesses, across multiple facilities to meet quarterly demands. The model comprised specific features to account for products with fed-batch or perfusion culture processes such as sequence-dependent changeover times, continuous culture constraints, and decoupled upstream and downstream operations that permit independent scheduling of each. Strategic inventory levels were accounted for by applying cost penalties when they were not met. A rolling time horizon methodology was utilized in conjunction with the MILP model and was shown to obtain solutions with greater optimality in less computational time than the full-scale model. The model was applied to an industrial case study to illustrate how the framework aids decisions regarding outsourcing capacity to third party manufacturers or building new facilities. The impact of variations on key parameters such as demand or titres on the optimal production plans and costs was captured. The analysis identified the critical ratio of in-house to contract manufacturing organization (CMO) manufacturing costs that led the optimization results to favor building a future facility over using a CMO. The tool predicted that if titres were higher than expected then the optimal solution would allocate more production to in-house facilities, where manufacturing costs were lower. Utilization graphs indicated when capacity expansion should be considered. © 2014 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers.

  14. Animal cell cultures: recent achievements and perspectives in the production of biopharmaceuticals.

    Science.gov (United States)

    Butler, Michael

    2005-08-01

    There has been a rapid increase in the number and demand for approved biopharmaceuticals produced from animal cell culture processes over the last few years. In part, this has been due to the efficacy of several humanized monoclonal antibodies that are required at large doses for therapeutic use. There have also been several identifiable advances in animal cell technology that has enabled efficient biomanufacture of these products. Gene vector systems allow high specific protein expression and some minimize the undesirable process of gene silencing that may occur in prolonged culture. Characterization of cellular metabolism and physiology has enabled the design of fed-batch and perfusion bioreactor processes that has allowed a significant improvement in product yield, some of which are now approaching 5 g/L. Many of these processes are now being designed in serum-free and animal-component-free media to ensure that products are not contaminated with the adventitious agents found in bovine serum. There are several areas that can be identified that could lead to further improvement in cell culture systems. This includes the down-regulation of apoptosis to enable prolonged cell survival under potentially adverse conditions. The characterization of the critical parameters of glycosylation should enable process control to reduce the heterogeneity of glycoforms so that production processes are consistent. Further improvement may also be made by the identification of glycoforms with enhanced biological activity to enhance clinical efficacy. The ability to produce the ever-increasing number of biopharmaceuticals by animal cell culture is dependent on sufficient bioreactor capacity in the industry. A recent shortfall in available worldwide culture capacity has encouraged commercial activity in contract manufacturing operations. However, some analysts indicate that this still may not be enough and that future manufacturing demand may exceed production capacity as the number

  15. Pediatric Biopharmaceutical Classification System: Using Age-Appropriate Initial Gastric Volume.

    Science.gov (United States)

    Shawahna, Ramzi

    2016-05-01

    Development of optimized pediatric formulations for oral administration can be challenging, time consuming, and financially intensive process. Since its inception, the biopharmaceutical classification system (BCS) has facilitated the development of oral drug formulations destined for adults. At least theoretically, the BCS principles are applied also to pediatrics. A comprehensive age-appropriate BCS has not been fully developed. The objective of this work was to provisionally classify oral drugs listed on the latest World Health Organization's Essential Medicines List for Children into an age-appropriate BCS. A total of 38 orally administered drugs were included in this classification. Dose numbers were calculated using age-appropriate initial gastric volume for neonates, 6-month-old infants, and children aging 1 year through adulthood. Using age-appropriate initial gastric volume and British National Formulary age-specific dosing recommendations in the calculation of dose numbers, the solubility classes shifted from low to high in pediatric subpopulations of 12 years and older for amoxicillin, 5 years, 12 years and older for cephalexin, 9 years and older for chloramphenicol, 3-4 years, 9-11 and 15 years and older for diazepam, 18 years and older (adult) for doxycycline and erythromycin, 8 years and older for phenobarbital, 10 years and older for prednisolone, and 15 years and older for trimethoprim. Pediatric biopharmaceutics are not fully understood where several knowledge gaps have been recently emphasized. The current biowaiver criteria are not suitable for safe application in all pediatric populations.

  16. Factors affecting future specialty choice among medical students in Kuwait

    OpenAIRE

    Marwan, Yousef; Al-Fouzan, Rawan; Al-Ajlan, Sarah; Al-Saleh, Mervat

    2012-01-01

    Background: Choosing a medical specialty can be either a daunting and confusing experience for some medical students and junior doctors or a foregone conclusion to others. The aim of this study is to evaluate factors affecting future specialty choice among medical students in Kuwait University. Methods: A self-administered questionnaire was used to collect data from medical students registered in Kuwait University during the academic year 2011/2012. Chi-square test and logistic regression wer...

  17. Opioid Prescriptions by Specialty in Ohio, 2010-2014.

    Science.gov (United States)

    Weiner, Scott G; Baker, Olesya; Rodgers, Ann F; Garner, Chad; Nelson, Lewis S; Kreiner, Peter W; Schuur, Jeremiah D

    2018-05-01

    The current US opioid epidemic is attributed to the large volume of prescribed opioids. This study analyzed the contribution of different medical specialties to overall opioids by evaluating the pill counts and morphine milligram equivalents (MMEs) of opioid prescriptions, stratified by provider specialty, and determined temporal trends. This was an analysis of the Ohio prescription drug monitoring program database, which captures scheduled medication prescriptions filled in the state as well as prescriber specialty. We extracted prescriptions for pill versions of opioids written in the calendar years 2010 to 2014. The main outcomes were the number of filled prescriptions, pill counts, MMEs, and extended-released opioids written by physicians in each specialty, and annual prescribing trends. There were 56,873,719 prescriptions for the studied opioids dispensed, for which 41,959,581 (73.8%) had prescriber specialty type available. Mean number of pills per prescription and MMEs were highest for physical medicine/rehabilitation (PM&R; 91.2 pills, 1,532 mg, N = 1,680,579), anesthesiology/pain (89.3 pills, 1,484 mg, N = 3,261,449), hematology/oncology (88.2 pills, 1,534 mg, N = 516,596), and neurology (84.4 pills, 1,230 mg, N = 573,389). Family medicine (21.8%) and internal medicine (17.6%) wrote the most opioid prescriptions overall. Time trends in the average number of pills and MMEs per prescription also varied depending on specialty. The numbers of pills and MMEs per opioid prescription vary markedly by prescriber specialty, as do trends in prescribing characteristics. Pill count and MME values define each specialty's contribution to overall opioid prescribing more accurately than the number of prescriptions alone.

  18. Prediction of specialty coffee cup quality based on near infrared spectra of green coffee beans.

    Science.gov (United States)

    Tolessa, Kassaye; Rademaker, Michael; De Baets, Bernard; Boeckx, Pascal

    2016-04-01

    The growing global demand for specialty coffee increases the need for improved coffee quality assessment methods. Green bean coffee quality analysis is usually carried out by physical (e.g. black beans, immature beans) and cup quality (e.g. acidity, flavour) evaluation. However, these evaluation methods are subjective, costly, time consuming, require sample preparation and may end up in poor grading systems. This calls for the development of a rapid, low-cost, reliable and reproducible analytical method to evaluate coffee quality attributes and eventually chemical compounds of interest (e.g. chlorogenic acid) in coffee beans. The aim of this study was to develop a model able to predict coffee cup quality based on NIR spectra of green coffee beans. NIR spectra of 86 samples of green Arabica beans of varying quality were analysed. Partial least squares (PLS) regression method was used to develop a model correlating spectral data to cupping score data (cup quality). The selected PLS model had a good predictive power for total specialty cup quality and its individual quality attributes (overall cup preference, acidity, body and aftertaste) showing a high correlation coefficient with r-values of 90, 90,78, 72 and 72, respectively, between measured and predicted cupping scores for 20 out of 86 samples. The corresponding root mean square error of prediction (RMSEP) was 1.04, 0.22, 0.27, 0.24 and 0.27 for total specialty cup quality, overall cup preference, acidity, body and aftertaste, respectively. The results obtained suggest that NIR spectra of green coffee beans are a promising tool for fast and accurate prediction of coffee quality and for classifying green coffee beans into different specialty grades. However, the model should be further tested for coffee samples from different regions in Ethiopia and test if one generic or region-specific model should be developed. Copyright © 2015 Elsevier B.V. All rights reserved.

  19. Evaluation of the educational climate for specialty trainees in dermatology.

    Science.gov (United States)

    Goulding, J M R; Passi, V

    2016-06-01

    Dermatology specialty trainees (STs) in the United Kingdom (UK) are few in number and will join a thinly spread national consultant body. It is of paramount importance to deliver training programmes of the highest quality for these doctors, central to which is the establishment and maintenance of an educational climate conducive to learning. To conduct a pilot study to evaluate the educational climate for dermatology STs in one UK deanery (West Midlands). Secondary analysis of published data was performed, from the UK's General Medical Council (GMC) national training survey, and the Job Evaluation Survey Tool (JEST) administered by the West Midlands deanery. A modified online version of the Postgraduate Hospital Educational Environment Measure (PHEEM) was circulated among dermatology STs. The GMC's survey data show that UK dermatology STs rated their training highly in comparison with undifferentiated UK postgraduate trainees. West Midlands dermatology STs (n = 22) scored very similarly to UK dermatology STs. The JEST gave broadly encouraging results, with 21/22 (95%) happy to recommend their posts to colleagues. The modified PHEEM yielded a global mean score of 96.5/152, attracting the descriptor 'more positive than negative but room for improvement'. Despite inherent methodological limitations, the GMC, JEST and modified PHEEM surveys have revealed useful comparative triangulated data which allows the conclusion that West Midlands dermatology STs seem to be training in a favourable educational climate. This represents an important facet of the quality assurance process for medical education, and allows insight into areas which may require improvement. © 2015 European Academy of Dermatology and Venereology.

  20. Quantification of biopharmaceuticals and biomarkers in complex biological matrices: a comparison of liquid chromatography coupled to tandem mass spectrometry and ligand binding assays

    NARCIS (Netherlands)

    Bults, Peter; van de Merbel, Nico C; Bischoff, Rainer

    2015-01-01

    The quantification of proteins (biopharmaceuticals or biomarkers) in complex biological samples such as blood plasma requires exquisite sensitivity and selectivity, as all biological matrices contain myriads of proteins that are all made of the same 20 proteinogenic amino acids, notwithstanding

  1. Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium

    NARCIS (Netherlands)

    Rup, B.; Pallardy, M.; Sikkema, D.; Albert, T.; Allez, M.; Broet, P.; Carini, C.; Creeke, P.; Davidson, J.; de Vries, N. [=Niek; Finco, D.; Fogdell-Hahn, A.; Havrdova, E.; Hincelin-Mery, A.; C Holland, M.; H Jensen, P. E.; Jury, E. C.; Kirby, H.; Kramer, D.; Lacroix-Desmazes, S.; Legrand, J.; Maggi, E.; Maillère, B.; Mariette, X.; Mauri, C.; Mikol, V.; Mulleman, D.; Oldenburg, J.; Paintaud, G.; R Pedersen, C.; Ruperto, N.; Seitz, R.; Spindeldreher, S.; Deisenhammer, F.

    2015-01-01

    Biopharmaceuticals (BPs) represent a rapidly growing class of approved and investigational drug therapies that is contributing significantly to advancing treatment in multiple disease areas, including inflammatory and autoimmune diseases, genetic deficiencies and cancer. Unfortunately, unwanted

  2. Orthopedic specialty hospitals: centers of excellence or greed machines?

    Science.gov (United States)

    Badlani, Neil; Boden, Scott; Phillips, Frank

    2012-03-07

    Orthopedic specialty hospitals have recently been the subject of debate. They are patient-centered, physician-friendly health care alternatives that take advantage of the economic efficiencies of specialization. Medically, they provide a higher quality of care and increase patient and physician satisfaction. Economically, they are more efficient and profitable than general hospitals. They also positively affect society through the taxes they pay and the beneficial aspects of the competition they provide to general hospitals. Their ability to provide a disruptive innovation to the existing hospital industry will lead to lower costs and greater access to health care. However, critics say that physician ownership presents potential conflicts of interest and leads to overuse of medical care. Some general hospitals are suffering as a result of unfair specialty hospital practices, and a few drastic medical complications have occurred at specialty hospitals. Specialty hospitals have been scrutinized for increasing the inequality of health care and continue to be a target of government regulations. In this article, the pros and cons are examined, and the Emory Orthopaedics and Spine Hospital is analyzed as an example. Orthopedic specialty hospitals provide excellent care and are great assets to society. Competition between specialty and general hospitals has provided added value to patients and taxpayers. However, physicians must take more responsibility in their appropriate and ethical leadership. It is critical to recognize financial conflicts of interest, disclose ownership, and act ethically. Patient care cannot be compromised. With thoughtful and efficient leadership, specialty hospitals can be an integral part of improving health care in the long term. Copyright 2012, SLACK Incorporated.

  3. Medical specialty preferences in early medical school training in Canada.

    Science.gov (United States)

    Vo, Anthony; McLean, Laurie; McInnes, Matthew D F

    2017-11-14

    To understand what medical students consider when choosing their specialty, prior to significant clinical exposure to develop strategies to provide adequate career counseling. A cross-sectional study was performed by distributing optional questionnaires to 165 first-year medical students at the University of Ottawa in their first month of training with a sample yield of 54.5% (n=90).  Descriptive statistics, analysis of variance, Spearman's rank correlation, Cronbach's alpha coefficient, Kaiser-Meyer-Olkin Measure, and exploratory factor analyses were used to analyze the anonymized results. "Job satisfaction", "lifestyle following training" and, "impact on the patient" were the three highest rated considerations when choosing a specialty.  Fifty-two and seventeen percent (n=24) and 57.89% (n=22) of males and females ranked non-surgical specialties as their top choice. Student confidence in their specialty preferences was moderate, meaning their preference could likely change (mean=2.40/5.00, SD=1.23). ANOVA showed no significant differences between confidence and population size (F(2,86)=0.290, p=0.75) or marital status (F(2,85)=0.354, p=0.70) in both genders combined. Five underlying factors that explained 44.32% of the total variance were identified. Five themes were identified to enhance career counseling. Medical students in their first month of training have already considered their specialty preferences, despite limited exposure. However, students are not fixed in their specialty preference. Our findings further support previous results but expand what students consider when choosing their specialty early in their training. Medical educators and administrators who recognize and understand the importance of these considerations may further enhance career counseling and medical education curricula.

  4. Pakistani medical students' specialty preference and the influencing factors.

    Science.gov (United States)

    Rehman, Anis; Rehman, Tariq; Shaikh, Muhammad Ateeb; Yasmin, Haleema; Asif, Ammara; Kafil, Hina

    2011-07-01

    To elucidate the specialty preferences of Pakistani medical students and the factors which influence medical students to make the decision regarding which specialty to pursue. Both basic sciences and clinical students from four medical colleges of Pakistan, i.e., Dow Medical College, Sindh Medical College, Liaquat National Medical College and Muhammad Medical College, were included in the cross-sectional survey during the period of July 2008 to Jan' 2009. After ethical acceptance, data was collected using convenient sampling technique. The questionnaire covered the following demographic details: 13 common specialties and 15 influencing factors. Questionnaires included in the analysis were 771. Most students gave preference to surgery and its associated sub-specialties (50.3%) followed by internal medicine (26.8%), paediatrics (23.2%), dermatology (16.7%), gynaecology and obstetrics (16.7%), psychiatry (13.1%), radiology (10.8%), ENT (8.8%), anaesthesiology (8.7%), administrative medicine (8.6%), orthopaedics (8.2%), ophthalmology (7.5%), and laboratory medicine (6.1%). The highly considered factors (regarding specialties) chosen by 70% of the medical students were: applicable to respective personalities of the individuals, prestige and respect, international opportunities, and time commitment. Surgical-skills, job availability, financial rating, academic performance, and a role model were moderately influencing factors. Hospital environment, parents, general practice, peer-pressure and personal health were the least influential. This trend suggests competition in surgery and its sub-specialties along with internal medicine, paediatrics, dermatology, gynaecology and obstetrics. Specialty suited to personality, time commitment, prestige/respect and international opportunity, influenced more than 70% of the students.

  5. Specialty and full-service hospitals: a comparative cost analysis.

    Science.gov (United States)

    Carey, Kathleen; Burgess, James F; Young, Gary J

    2008-10-01

    To compare the costs of physician-owned cardiac, orthopedic, and surgical single specialty hospitals with those of full-service hospital competitors. The primary data sources are the Medicare Cost Reports for 1998-2004 and hospital inpatient discharge data for three of the states where single specialty hospitals are most prevalent, Texas, California, and Arizona. The latter were obtained from the Texas Department of State Health Services, the California Office of Statewide Health Planning and Development, and the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project. Additional data comes from the American Hospital Association Annual Survey Database. We identified all physician-owned cardiac, orthopedic, and surgical specialty hospitals in these three states as well as all full-service acute care hospitals serving the same market areas, defined using Dartmouth Hospital Referral Regions. We estimated a hospital cost function using stochastic frontier regression analysis, and generated hospital specific inefficiency measures. Application of t-tests of significance compared the inefficiency measures of specialty hospitals with those of full-service hospitals to make general comparisons between these classes of hospitals. Results do not provide evidence that specialty hospitals are more efficient than the full-service hospitals with whom they compete. In particular, orthopedic and surgical specialty hospitals appear to have significantly higher levels of cost inefficiency. Cardiac hospitals, however, do not appear to be different from competitors in this respect. Policymakers should not embrace the assumption that physician-owned specialty hospitals produce patient care more efficiently than their full-service hospital competitors.

  6. License Compliance Issues For Biopharmaceuticals: Special Challenges For Negotiations Between Companies And Non-Profit Research Institutions

    Science.gov (United States)

    Ponzio, Todd A.; Feindt, Hans; Ferguson, Steven

    2011-01-01

    Summary Biopharmaceuticals are therapeutic products based on biotechnology. They are manufactured by or from living organisms and are the most complex of all commercial medicines to develop, manufacture and qualify for regulatory approval. In recent years biopharmaceuticals have rapidly increased in number and importance with over 4001 already marketed in the U.S. and European markets alone. Many companies throughout the world are now ramping up investments in biopharmaceutical R&D and expanding their portfolios through licensing of early-stage biotechnologies from universities and other non-profit research institutions, and there is an increasing number of license agreements for biopharmaceutical product development relative to traditional small molecule drug compounds. This trend will only continue as large numbers of biosimilars and biogenerics enter the market. A primary goal of technology transfer offices associated with publicly-funded, non-profit research institutions is to establish patent protection for inventions deemed to have commercial potential and license them for product development. Such licenses help stimulate economic development and job creation, bring a stream of royalty revenue to the institution and, hopefully, advance the public good or public health by bringing new and useful products to market. In the course of applying for such licenses, a commercial development plan is usually put forth by the license applicant. This plan indicates the path the applicant expects to follow to bring the licensed invention to market. In the case of small molecule drug compounds, there exists a widely-recognized series of clinical development steps, dictated by regulatory requirements, that must be met to bring a new drug to market, such as completion of preclinical toxicology, Phase 1, 2 and 3 testing and product approvals. These steps often become the milestone/benchmark schedule incorporated into license agreements which technology transfer offices use to

  7. Microencapsulation for the Therapeutic Delivery of Drugs, Live Mammalian and Bacterial Cells, and Other Biopharmaceutics: Current Status and Future Directions

    Directory of Open Access Journals (Sweden)

    Catherine Tomaro-Duchesneau

    2013-01-01

    Full Text Available Microencapsulation is a technology that has shown significant promise in biotherapeutics, and other applications. It has been proven useful in the immobilization of drugs, live mammalian and bacterial cells and other cells, and other biopharmaceutics molecules, as it can provide material structuration, protection of the enclosed product, and controlled release of the encapsulated contents, all of which can ensure efficient and safe therapeutic effects. This paper is a comprehensive review of microencapsulation and its latest developments in the field. It provides a comprehensive overview of the technology and primary goals of microencapsulation and discusses various processes and techniques involved in microencapsulation including physical, chemical, physicochemical, and other methods involved. It also summarizes the state-of-the-art successes of microencapsulation, specifically with regard to the encapsulation of microorganisms, mammalian cells, drugs, and other biopharmaceutics in various diseases. The limitations and future directions of microencapsulation technologies are also discussed.

  8. License Compliance Issues For Biopharmaceuticals: Special Challenges For Negotiations Between Companies And Non-Profit Research Institutions.

    Science.gov (United States)

    Ponzio, Todd A; Feindt, Hans; Ferguson, Steven

    2011-09-01

    Biopharmaceuticals are therapeutic products based on biotechnology. They are manufactured by or from living organisms and are the most complex of all commercial medicines to develop, manufacture and qualify for regulatory approval. In recent years biopharmaceuticals have rapidly increased in number and importance with over 400() already marketed in the U.S. and European markets alone. Many companies throughout the world are now ramping up investments in biopharmaceutical R&D and expanding their portfolios through licensing of early-stage biotechnologies from universities and other non-profit research institutions, and there is an increasing number of license agreements for biopharmaceutical product development relative to traditional small molecule drug compounds. This trend will only continue as large numbers of biosimilars and biogenerics enter the market.A primary goal of technology transfer offices associated with publicly-funded, non-profit research institutions is to establish patent protection for inventions deemed to have commercial potential and license them for product development. Such licenses help stimulate economic development and job creation, bring a stream of royalty revenue to the institution and, hopefully, advance the public good or public health by bringing new and useful products to market. In the course of applying for such licenses, a commercial development plan is usually put forth by the license applicant. This plan indicates the path the applicant expects to follow to bring the licensed invention to market. In the case of small molecule drug compounds, there exists a widely-recognized series of clinical development steps, dictated by regulatory requirements, that must be met to bring a new drug to market, such as completion of preclinical toxicology, Phase 1, 2 and 3 testing and product approvals. These steps often become the milestone/benchmark schedule incorporated into license agreements which technology transfer offices use to monitor

  9. Microencapsulation for the Therapeutic Delivery of Drugs, Live Mammalian and Bacterial Cells, and Other Biopharmaceutics: Current Status and Future Directions

    Science.gov (United States)

    Saha, Shyamali; Malhotra, Meenakshi; Kahouli, Imen; Prakash, Satya

    2013-01-01

    Microencapsulation is a technology that has shown significant promise in biotherapeutics, and other applications. It has been proven useful in the immobilization of drugs, live mammalian and bacterial cells and other cells, and other biopharmaceutics molecules, as it can provide material structuration, protection of the enclosed product, and controlled release of the encapsulated contents, all of which can ensure efficient and safe therapeutic effects. This paper is a comprehensive review of microencapsulation and its latest developments in the field. It provides a comprehensive overview of the technology and primary goals of microencapsulation and discusses various processes and techniques involved in microencapsulation including physical, chemical, physicochemical, and other methods involved. It also summarizes the state-of-the-art successes of microencapsulation, specifically with regard to the encapsulation of microorganisms, mammalian cells, drugs, and other biopharmaceutics in various diseases. The limitations and future directions of microencapsulation technologies are also discussed. PMID:26555963

  10. Seashell specialties and food handling in Slovene Istria restaurants

    Directory of Open Access Journals (Sweden)

    Tamara POKLAR VATOVEC

    2015-11-01

    Full Text Available The purpose of the research was to evaluate the offer of seashell specialties in Slovene Istria restaurants, and to assess food safety knowledge (gained through formal and informal education as well as to assess the behaviour of food handlers in preparing shell dishes. A self-administered questionnaire was designed that included four sections: a demographic section, a general section, a restaurant menu offer, and a food safety section related to preparation of seashell specialties. Seashell specialties were offered in 41 restaurants, of which the employed food handlers 24 attended formal education and 17 informal education. Seashells specialties and seashell menus are commonly part of the culinary and gastronomic specialties along the Slovene coast, with the most frequently offered main dish being “Blue Mussels alla Busara”. Results the questionnaire indicated poor food safety knowledge and poor behaviour regardless of the (informal education of those who prepared the dishes. We propose that formal education for catering workers preparing shell dishes should be much more emphasized.

  11. Analyzing Factors to Improve Service Quality of Local Specialties Restaurants: A Comparison with Fast Food Restaurants in Southern Vietnam

    OpenAIRE

    Lai Wang Wang; Thanh Tuyen Tran

    2014-01-01

    The top fast food restaurant brands like KFC and MacDonald?s have gone global and demonstrated their successful business strategies through providing quick-service and convenience for customers. Meanwhile, local specialty food has recently emerged as a phenomenon attracting customers? attention on traditional value of ethnic food culture. The purpose of this study is to conduct a regional survey in Vietnamese restaurant companies to identify some key factors that make customers interested in ...

  12. Evaluation of the physicochemical and biopharmaceutical properties of fluoro-indomethacin.

    Science.gov (United States)

    Mori, Michela M; Airaksinen, Anu J; Hirvonen, Jouni T; Santos, Hélder A; Caramella, Carla M

    2013-01-01

    Drug nanocarriers have shown great potential in therapy and as diagnostic probes, e.g. in imaging of cancer and inflammation. Imaging can be applied to localize the carrier or the drug itself in the body and/or tissues. In this particular case it is important that drug molecules have the characteristics for possible detection, e.g. after modification with positron emission tomography compliant radioisotopes, without affecting their pharmacological behavior. In order to easily and efficiently follow the ADME profile of the drug after loaded into nanocarriers, the drug can be radiolabelled with, e.g. 18F-label, in order to assess its biodistribution after enteral and parenteral administration in rats. However, this is only possible if the derivative compound behaves similarly to the parent drug compound. In this study, indomethacin (a poorly water-soluble drug) was chosen as a model compound and aimed to evaluate the physicochemical and biopharmaceutical properties of an analog of indomethacin (IMC), fluoro-indomethacin (F-IMC). Although some of the physicochemical and biopharmaceutical properties of IMC are already known, in order to establish a feasible comparison between IMC and F-IMC, the behavior of the former was also investigated in the same conditions as for F-IMC. In this context, both IMC and F-IMC were thermally and morphologically studied. Furthermore, the following properties were also studied for both compounds: pKa and logP, solubility and dissolution profiles at physiological pH values, and toxicity at different concentrations in Caco-2 cells. Finally, the transport across Caco- 2 monolayers of the IMC and F-IMC at physiological pH range was also investigated. The results obtained showed similar values in pKalogP, solubility, dissolution, cytotoxicity, and permeability for both compounds. Thus, there might be strong evidence that both IMC and F-IMC should have a similar ADME behavior and profiles in vivo. The results provide fundamental tools and

  13. Improved Protease-Targeting and Biopharmaceutical Properties of Novel Prodrugs of Ganciclovir.

    Science.gov (United States)

    Sun, Kefeng; Xu, Hao; Hilfinger, John L; Lee, Kyung-Dall; Provoda, Chester J; Sabit, Hairat; Amidon, Gordon L

    2018-02-05

    The prodrug strategy has been frequently employed as a chemical approach for overcoming the disadvantages of existing parent drugs. In this report, we synthesized four monoester prodrugs of ganciclovir, an anticytomegalovirus drug, and demonstrated their potential advantages in protease-targeted activation and biopharmaceutical profiles over the parent compound. We demonstrated that these four prodrugs of ganciclovir, i.e., N-benzyloxycarbonyl-(L)-alanine-ganciclovir (CbzAlaGCV), N-benzyloxycarbonyl-(α,l)-aminobutyric acid-ganciclovir (CbzAbuGCV), N-acetyl-(l)-phenylalanine-(l)-alanine-ganciclovir (AcPheAlaGCV), and N-acetyl-(l)-phenylalanine-(α,l)-aminobutyric acid-ganciclovir (AcPheAbuGCV), are hydrolytically activated by the protease of human cytomegalovirus (hCMV), a serine protease that possesses intrinsic esterase activities. CbzAlaGCV and AcPheAlaGCV were found to be activated at a higher rate by the hCMV protease than CbzAbuGCV and AcPheAbuGCV. These ganciclovir prodrugs could potentially be targeted to selective activation by the hCMV protease which is only present at the viral infection sites, thereby achieving higher efficacy and lower systemic toxicity. The tissue stability, cellular uptake, and trans-epithelial transport of these ganciclovir prodrugs were also characterized. The N-acetylated dipeptide prodrugs of ganciclovir were found to be generally more stable than Cbz-amino acid prodrugs in various tissue matrices. Among the four prodrug candidates, AcPheAbuGCV was the most stable in human cell homogenates, plasma, and pooled liver microsomes. AcPheAbuGCV also possessed a superior cellular uptake profile and permeability across epithelial cell monolayers. Since the targeting and selective activation of a prodrug is determined by not only its rate of hydrolysis catalyzed by the hCMV protease target but also its biopharmaceutical properties, i.e., oral absorption and systemic availability, AcPheAbuGCV is considered the best overall candidate among

  14. Specialty pharmacy: an emerging area of interest for medical management.

    Science.gov (United States)

    Dong, Xiaoli; Fetterolf, Donald

    2005-04-01

    Specialty pharmaceuticals are expensive injectable and infusion therapies used to treat patients with chronic or life-threatening diseases. The high cost of these agents and their frequent usage in chronic diseases represent not only challenges, but also opportunities for medical management programs to improve the quality of care and moderate the rapid cost escalation seen in the industry. The number and variety of these agents have been increasing significantly, with hundreds of drug candidates in the development pipeline. The specialty pharmacy industry also is going through a consolidation stage, both horizontally and vertically. Industry approaches to medical management include the acquisition of specialty pharmacy companies, restrictive contracting to achieve concentrated buying power, and the development of utilization management strategies.

  15. Women otolaryngologist representation in specialty society membership and leadership positions.

    Science.gov (United States)

    Choi, Sukgi S; Miller, Robert H

    2012-11-01

    To determine the proportion of female otolaryngologists in leadership positions relative to their number in the specialty, their membership in various otolaryngology organizations, and age. Cross-sectional analyses of otolaryngology organization membership with a subgroup analysis on female membership and leadership proportion comparing 5-year male/female cohort groups. Information on the number of members and leaders was obtained from various specialty societies by direct communication and from their Web sites between June and December 2010. The number of female and male otolaryngologists and their age distribution in 5-year age groups was obtained from the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). Statistical analyses were used to determine whether women had proportional membership and leadership representation in various specialty societies. Additionally, female representation in other leadership roles was analyzed using the male/female ratio within the 5-year cohort groups. Female otolaryngologists were found to constitute approximately 11% of practicing otolaryngologists. The American Society of Pediatric Otolaryngology had a higher proportion of female members (22%) compared to five other societies. When the gender composition within each organization was taken into account, female representation in specialty society leadership positions was proportionate to their membership across all societies. When gender and age were considered, women have achieved proportionate representation in each of the specialty societies' leadership positions. There was also proportionate representation of females as program directors, American Board of Otolaryngology directors, Residency Review Committee members, and journal editors/editorial board members. Finally, fewer female chairs or chiefs of departments/divisions were seen, but when age was taken into consideration, this difference was no longer significant. Women have achieved parity in

  16. Optimization‐based framework for resin selection strategies in biopharmaceutical purification process development

    Science.gov (United States)

    Liu, Songsong; Gerontas, Spyridon; Gruber, David; Turner, Richard; Titchener‐Hooker, Nigel J.

    2017-01-01

    This work addresses rapid resin selection for integrated chromatographic separations when conducted as part of a high‐throughput screening exercise during the early stages of purification process development. An optimization‐based decision support framework is proposed to process the data generated from microscale experiments to identify the best resins to maximize key performance metrics for a biopharmaceutical manufacturing process, such as yield and purity. A multiobjective mixed integer nonlinear programming model is developed and solved using the ε‐constraint method. Dinkelbach's algorithm is used to solve the resulting mixed integer linear fractional programming model. The proposed framework is successfully applied to an industrial case study of a process to purify recombinant Fc Fusion protein from low molecular weight and high molecular weight product related impurities, involving two chromatographic steps with eight and three candidate resins for each step, respectively. The computational results show the advantage of the proposed framework in terms of computational efficiency and flexibility. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers Biotechnol. Prog., 33:1116–1126, 2017 PMID:28393478

  17. Mechanical characterisation of agarose-based chromatography resins for biopharmaceutical manufacture.

    Science.gov (United States)

    Nweke, Mauryn C; McCartney, R Graham; Bracewell, Daniel G

    2017-12-29

    Mechanical characterisation of agarose-based resins is an important factor in ensuring robust chromatographic performance in the manufacture of biopharmaceuticals. Pressure-flow profiles are most commonly used to characterise these properties. There are a number of drawbacks with this method, including the potential need for several re-packs to achieve the desired packing quality, the impact of wall effects on experimental set up and the quantities of chromatography media and buffers required. To address these issues, we have developed a dynamic mechanical analysis (DMA) technique that characterises the mechanical properties of resins based on the viscoelasticity of a 1ml sample of slurry. This technique was conducted on seven resins with varying degrees of mechanical robustness and the results were compared to pressure-flow test results on the same resins. Results show a strong correlation between the two techniques. The most mechanically robust resin (Capto Q) had a critical velocity 3.3 times higher than the weakest (Sepharose CL-4B), whilst the DMA technique showed Capto Q to have a slurry deformation rate 8.3 times lower than Sepharose CL-4B. To ascertain whether polymer structure is indicative of mechanical strength, scanning electron microscopy images were also used to study the structural properties of each resin. Results indicate that DMA can be used as a small volume, complementary technique for the mechanical characterisation of chromatography media. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

  18. A non-binary biopharmaceutical classification of drugs: the ABΓ system.

    Science.gov (United States)

    Macheras, Panos; Karalis, Vangelis

    2014-04-10

    The purpose of the present work is to develop a non-binary biopharmaceutical classification system the so called ABΓ system. The original mathematical model used for the development of BCS, appropriately modified, was applied to estimate the limiting values of drug solubility and permeability when the fraction of dose absorbed, Fa, was 0.90 or 0.20. The ABΓ system is based on the fraction of dose absorbed and relies on permeability, solubility plane. The first category (A, alpha) includes drugs with Fa ≥ 0.90, whereas the B (beta) category consists of drugs with Fa ≤ 0.20. The area lying between the two boundaries of A and B defines the third category (gamma), Γ, (0.20

  19. Continuous counter-current chromatography for capture and polishing steps in biopharmaceutical production.

    Science.gov (United States)

    Steinebach, Fabian; Müller-Späth, Thomas; Morbidelli, Massimo

    2016-09-01

    The economic advantages of continuous processing of biopharmaceuticals, which include smaller equipment and faster, efficient processes, have increased interest in this technology over the past decade. Continuous processes can also improve quality assurance and enable greater controllability, consistent with the quality initiatives of the FDA. Here, we discuss different continuous multi-column chromatography processes. Differences in the capture and polishing steps result in two different types of continuous processes that employ counter-current column movement. Continuous-capture processes are associated with increased productivity per cycle and decreased buffer consumption, whereas the typical purity-yield trade-off of classical batch chromatography can be surmounted by continuous processes for polishing applications. In the context of continuous manufacturing, different but complementary chromatographic columns or devices are typically combined to improve overall process performance and avoid unnecessary product storage. In the following, these various processes, their performances compared with batch processing and resulting product quality are discussed based on a review of the literature. Based on various examples of applications, primarily monoclonal antibody production processes, conclusions are drawn about the future of these continuous-manufacturing technologies. Copyright © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  20. Workflow for Criticality Assessment Applied in Biopharmaceutical Process Validation Stage 1

    Directory of Open Access Journals (Sweden)

    Thomas Zahel

    2017-10-01

    Full Text Available Identification of critical process parameters that impact product quality is a central task during regulatory requested process validation. Commonly, this is done via design of experiments and identification of parameters significantly impacting product quality (rejection of the null hypothesis that the effect equals 0. However, parameters which show a large uncertainty and might result in an undesirable product quality limit critical to the product, may be missed. This might occur during the evaluation of experiments since residual/un-modelled variance in the experiments is larger than expected a priori. Estimation of such a risk is the task of the presented novel retrospective power analysis permutation test. This is evaluated using a data set for two unit operations established during characterization of a biopharmaceutical process in industry. The results show that, for one unit operation, the observed variance in the experiments is much larger than expected a priori, resulting in low power levels for all non-significant parameters. Moreover, we present a workflow of how to mitigate the risk associated with overlooked parameter effects. This enables a statistically sound identification of critical process parameters. The developed workflow will substantially support industry in delivering constant product quality, reduce process variance and increase patient safety.

  1. Human Embryonic Kidney 293 Cells: A Vehicle for Biopharmaceutical Manufacturing, Structural Biology, and Electrophysiology.

    Science.gov (United States)

    Hu, Jianwen; Han, Jizhong; Li, Haoran; Zhang, Xian; Liu, Lan Lan; Chen, Fei; Zeng, Bin

    2018-01-01

    Mammalian cells, e.g., CHO, BHK, HEK293, HT-1080, and NS0 cells, represent important manufacturing platforms in bioengineering. They are widely used for the production of recombinant therapeutic proteins, vaccines, anticancer agents, and other clinically relevant drugs. HEK293 (human embryonic kidney 293) cells and their derived cell lines provide an attractive heterologous system for the development of recombinant proteins or adenovirus productions, not least due to their human-like posttranslational modification of protein molecules to provide the desired biological activity. Secondly, they also exhibit high transfection efficiency yielding high-quality recombinant proteins. They are easy to maintain and express with high fidelity membrane proteins, such as ion channels and transporters, and thus are attractive for structural biology and electrophysiology studies. In this article, we review the literature on HEK293 cells regarding their origins but also stress their advancements into the different cell lines engineered and discuss some significant aspects which make them versatile systems for biopharmaceutical manufacturing, drug screening, structural biology research, and electrophysiology applications. © 2018 S. Karger AG, Basel.

  2. Rational design and optimization of downstream processes of virus particles for biopharmaceutical applications: current advances.

    Science.gov (United States)

    Vicente, Tiago; Mota, José P B; Peixoto, Cristina; Alves, Paula M; Carrondo, Manuel J T

    2011-01-01

    The advent of advanced therapies in the pharmaceutical industry has moved the spotlight into virus-like particles and viral vectors produced in cell culture holding great promise in a myriad of clinical targets, including cancer prophylaxis and treatment. Even though a couple of cases have reached the clinic, these products have yet to overcome a number of biological and technological challenges before broad utilization. Concerning the manufacturing processes, there is significant research focusing on the optimization of current cell culture systems and, more recently, on developing scalable downstream processes to generate material for pre-clinical and clinical trials. We review the current options for downstream processing of these complex biopharmaceuticals and underline current advances on knowledge-based toolboxes proposed for rational optimization of their processing. Rational tools developed to increase the yet scarce knowledge on the purification processes of complex biologicals are discussed as alternative to empirical, "black-boxed" based strategies classically used for process development. Innovative methodologies based on surface plasmon resonance, dynamic light scattering, scale-down high-throughput screening and mathematical modeling for supporting ion-exchange chromatography show great potential for a more efficient and cost-effective process design, optimization and equipment prototyping. Copyright © 2011 Elsevier Inc. All rights reserved.

  3. Immune checkpoint blockade therapy: The 2014 Tang prize in biopharmaceutical science

    Directory of Open Access Journals (Sweden)

    Ya-Shan Chen

    2015-02-01

    Full Text Available The first Tang Prize for Biopharmaceutical Science has been awarded to Prof. James P. Allison and Prof. Tasuku Honjo for their contributions leading to an entirely new way to treat cancer by blocking the molecules cytotoxic T lymphocyte-associated antigen 4 (CTLA-4 and programmed cell death protein 1 (PD-1 that turn off immune response. The treatment, called "immune checkpoint blockade therapy," has opened a new therapeutic era. Here the discoveries of the immune checkpoints and how they contribute to the maintenance of self-tolerance, as well as how to protect tissues from the excess immune responses causing damage are reviewed. The efforts made by Prof. Allison and Prof. Honjo for developing the most promising approaches to activate therapeutic antitumor immunity are also summarized. Since these certain immune checkpoint pathways appear to be one of the major mechanisms resulting in immune escape of tumors, the presence of anti-CTLA-4 and/or anti-PD-1 should contribute to removal of the inhibition signals for T cell activation. Subsequently, it will enhance specific T cell activation and, therefore, strengthen antitumor immunity.

  4. Particle shedding from peristaltic pump tubing in biopharmaceutical drug product manufacturing.

    Science.gov (United States)

    Saller, Verena; Matilainen, Julia; Grauschopf, Ulla; Bechtold-Peters, Karoline; Mahler, Hanns-Christian; Friess, Wolfgang

    2015-04-01

    In a typical manufacturing setup for biopharmaceutical drug products, the fill and dosing pump is placed after the final sterile filtration unit in order to ensure adequate dispensing accuracy and avoid backpressure peaks. Given the sensitivity of protein molecules, peristaltic pumps are often preferred over piston pumps. However, particles may be shed from the silicone tubing employed. In this study, particle shedding and a potential turbidity increase during peristaltic pumping of water and buffer were investigated using three types of commercially available silicone tubing. In the recirculates, mainly particles of around 200 nm next to a very small fraction of particles in the lower micrometer range were found. Using 3D laser scanning microscopy, surface roughness of the inner tubing surface was found to be a determining factor for particle shedding from silicone tubing. As the propensity toward particle shedding varied between tubing types and also cannot be concluded from manufacturer's specifications, individual testing with the presented methods is recommended during tubing qualification. Choosing low abrasive tubing can help to further minimize the very low particle counts to be expected in pharmaceutical drug products. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  5. Lipid Based Formulations of Biopharmaceutics Classification System (BCS Class II Drugs: Strategy, Formulations, Methods and Saturation

    Directory of Open Access Journals (Sweden)

    Šoltýsová I.

    2016-12-01

    Full Text Available Active ingredients in pharmaceuticals differ by their physico-chemical properties and their bioavailability therefore varies. The most frequently used and most convenient way of administration of medicines is oral, however many drugs are little soluble in water. Thus they are not sufficiently effective and suitable for such administration. For this reason a system of lipid based formulations (LBF was developed. Series of formulations were prepared and tested in water and biorelevant media. On the basis of selection criteria, there were selected formulations with the best emulsification potential, good dispersion in the environment and physical stability. Samples of structurally different drugs included in the Class II of the Biopharmaceutics classification system (BCS were obtained, namely Griseofulvin, Glibenclamide, Carbamazepine, Haloperidol, Itraconazol, Triclosan, Praziquantel and Rifaximin, for testing of maximal saturation in formulations prepared from commercially available excipients. Methods were developed for preparation of formulations, observation of emulsification and its description, determination of maximum solubility of drug samples in the respective formulation and subsequent analysis. Saturation of formulations with drugs showed that formulations 80 % XA and 20 % Xh, 35 % XF and 65 % Xh were best able to dissolve the drugs which supports the hypothesis that it is desirable to identify limited series of formulations which could be generally applied for this purpose.

  6. Aftermarket Performance of Health Care and Biopharmaceutical IPOs: Evidence From ASEAN Countries.

    Science.gov (United States)

    Komenkul, Kulabutr; Kiranand, Santi

    2017-01-01

    We examine the evidence from the long-run abnormal returns using data for 76 health care and biopharmaceutical initial public offerings (IPOs) listed in a 29-year period between 1986 and 2014 in the Association of Southeast Asian Nations (ASEAN) countries such as Indonesia, Malaysia, Singapore, Thailand, the Philippines, Vietnam, Myanmar, and Laos. Based on the event-time approach, the 3-year stock returns of the IPOs are investigated using cumulative abnormal return (CAR) and buy-and-hold abnormal return (BHAR). As a robustness check, the calendar-time approach, related to the market model as well as Fama-French and Carhart models, was applied for verifying long-run abnormal returns. We found evidence that the health care IPOs overperform in the long-run, irrespective of the alternative benchmarks and methods. In addition, when we divide our sample into 5 groups by listing countries, our results show that the health care stock prices of the Singaporean firms behaved differently from those of most of the other firms in ASEAN. The Singaporean IPOs are characterized by a worse post-offering performance, whereas the IPOs of Malaysian and Thai health care companies performed better in the long-run.

  7. Bioengineering of rFVIIa Biopharmaceutical and Structure Characterization for Biosimilarity Assessment

    Directory of Open Access Journals (Sweden)

    Othman Montacir

    2018-01-01

    Full Text Available Eptacog alfa (NovoSeven® is a vitamin K-dependent recombinant Factor VIIa produced by genetic engineering from baby hamster kidney (BHK cells as a single peptide chain of 406 residues. After activation, it consists of a light chain (LC of 152 amino and a heavy chain (HC of 254 amino acids. Recombinant FVIIa undergoes many post-translational modifications (PTMs. The first ten glutamic acids of the N-terminal moiety are γ-carboxylated, Asn145 and Asn322 are N-glycosylated, and Ser52 and Ser60 are O-glycosylated. A head-to-head biosimilarity study was conducted for the originator and the first biosimilar AryoSeven™ to evaluate comparable bioengineering. Physicochemical properties were analyzed based on mass spectrometry, including intact mass, PTMs and higher-order structure. Both biotherapeutics exhibit a batch-to-batch variability in their N-glycan profiles. N-Glycopeptide analysis with UHPLC-QTOF-MSE confirmed N-glycosylation sites as well as two different O-glycopeptide sites. Ser60 was found to be O-fucosylated and Ser52 had O-glucose or O-glucose-(xylose1,2 motifs as glycan variants. Ion mobility spectrometry (TWIMS and NMR spectroscopy data affirm close similarity of the higher-order structure of both biologicals. Potency of the biodrugs was analyzed by a coagulation assay demonstrating comparable bioactivity. Consequently, careful process optimization led to a stable production process of the biopharmaceuticals.

  8. Profiling biopharmaceutical deciding properties of absorption of lansoprazole enteric-coated tablets using gastrointestinal simulation technology.

    Science.gov (United States)

    Wu, Chunnuan; Sun, Le; Sun, Jin; Yang, Yajun; Ren, Congcong; Ai, Xiaoyu; Lian, He; He, Zhonggui

    2013-09-10

    The aim of the present study was to correlate in vitro properties of drug formulation to its in vivo performance, and to elucidate the deciding properties of oral absorption. Gastrointestinal simulation technology (GST) was used to simulate the in vivo plasma concentration-time curve and was implemented by GastroPlus™ software. Lansoprazole, a typical BCS class II drug, was chosen as a model drug. Firstly, physicochemical and pharmacokinetic parameters of lansoprazole were determined or collected from literature to construct the model. Validation of the developed model was performed by comparison of the predicted and the experimental plasma concentration data. We found that the predicted curve was in a good agreement with the experimental data. Then, parameter sensitivity analysis (PSA) was performed to find the key parameters of oral absorption. The absorption was particularly sensitive to dose, solubility and particle size for lansoprazole enteric-coated tablets. With a single dose of 30 mg and the solubility of 0.04 mg/ml, the absorption was complete. A good absorption could be achieved with lansoprazole particle radius down to about 25 μm. In summary, GST is a useful tool for profiling biopharmaceutical deciding properties of absorption of lansoprazole enteric-coated tablets and guiding the formulation optimization. Crown Copyright © 2013. Published by Elsevier B.V. All rights reserved.

  9. Closed-loop optimization of chromatography column sizing strategies in biopharmaceutical manufacture.

    Science.gov (United States)

    Allmendinger, Richard; Simaria, Ana S; Turner, Richard; Farid, Suzanne S

    2014-10-01

    This paper considers a real-world optimization problem involving the identification of cost-effective equipment sizing strategies for the sequence of chromatography steps employed to purify biopharmaceuticals. Tackling this problem requires solving a combinatorial optimization problem subject to multiple constraints, uncertain parameters, and time-consuming fitness evaluations. An industrially-relevant case study is used to illustrate that evolutionary algorithms can identify chromatography sizing strategies with significant improvements in performance criteria related to process cost, time and product waste over the base case. The results demonstrate also that evolutionary algorithms perform best when infeasible solutions are repaired intelligently, the population size is set appropriately, and elitism is combined with a low number of Monte Carlo trials (needed to account for uncertainty). Adopting this setup turns out to be more important for scenarios where less time is available for the purification process. Finally, a data-visualization tool is employed to illustrate how user preferences can be accounted for when it comes to selecting a sizing strategy to be implemented in a real industrial setting. This work demonstrates that closed-loop evolutionary optimization, when tuned properly and combined with a detailed manufacturing cost model, acts as a powerful decisional tool for the identification of cost-effective purification strategies. © 2013 The Authors. Journal of Chemical Technology & Biotechnology published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

  10. Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know.

    Science.gov (United States)

    Strober, Bruce E; Armour, Katherine; Romiti, Ricardo; Smith, Catherine; Tebbey, Paul W; Menter, Alan; Leonardi, Craig

    2012-02-01

    The entry of biosimilar forms of biopharmaceutical therapies for the treatment of psoriasis and other immune-mediated disorders has provoked considerable interest. Although dermatologists are accustomed to the use of a wide range of generic topical agents, recognition of key differences between original agent (ie, the name brand) and the generic or biosimilar agent is necessary to support optimal therapy management and patient care. In this review we have summarized the current state of the art related to the impending introduction of biosimilars into dermatology. Biosimilars represent important interventions that are less expensive and hence offer the potential to deliver benefit to large numbers of patients who may not currently be able to access these therapies. But the development of biosimilars is not equivalent to that of small molecule generic therapies because of differences in molecular structure and processes of manufacture. The planned regulatory guidelines and path to approval may not encompass all of these potentially important differences and this may have clinical relevance to the prescriber and patient. Consequently, we have identified a series of key issues that should be considered to support the full potential of biosimilars for the treatment of psoriasis; ie, that of increased access to appropriate therapy for the psoriasis population worldwide. Copyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  11. Computational fluid dynamics (CFD) insights into agitation stress methods in biopharmaceutical development.

    Science.gov (United States)

    Bai, Ge; Bee, Jared S; Biddlecombe, James G; Chen, Quanmin; Leach, W Thomas

    2012-02-28

    Agitation of small amounts of liquid is performed routinely in biopharmaceutical process, formulation, and packaging development. Protein degradation commonly results from agitation, but the specific stress responsible or degradation mechanism is usually not well understood. Characterization of the agitation stress methods is critical to identifying protein degradation mechanisms or specific sensitivities. In this study, computational fluid dynamics (CFD) was used to model agitation of 1 mL of fluid by four types of common laboratory agitation instruments, including a rotator, orbital shaker, magnetic stirrer and vortex mixer. Fluid stresses in the bulk liquid and near interfaces were identified, quantified and compared. The vortex mixer provides the most intense stresses overall, while the stir bar system presented locally intense shear proximal to the hydrophobic stir bar surface. The rotator provides gentler fluid stresses, but the air-water interfacial area and surface stresses are relatively high given its low rotational frequency. The orbital shaker provides intermediate-level stresses but with the advantage of a large stable platform for consistent vial-to-vial homogeneity. Selection of experimental agitation methods with targeted types and intensities of stresses can facilitate better understanding of protein degradation mechanisms and predictability for "real world" applications. Copyright © 2011 Elsevier B.V. All rights reserved.

  12. Isolation and characterization of bioactive fungi from shark Carcharodon carcharias' gill with biopharmaceutical prospects

    Science.gov (United States)

    Zhang, Yi; Han, Jinyuan; Feng, Yan; Mu, Jun; Bao, Haiyan; Kulik, Andreas; Grond, Stephanie

    2016-01-01

    Until recently, little was known about the fungi found in shark gills and their biomedicinal potential. In this article, we described the isolation, bioactivity, diversity, and secondary metabolites of bioactive fungi from the gill of a shark ( Carcharodon carcharias). A total of 115 isolates were obtained and grown in 12 culture media. Fifty-eight of these isolates demonstrated significant activity in four antimicrobial, pesticidal, and cytotoxic bioassay models. Four randomly selected bioactive isolates inhibited human cancer cell proliferation during re-screening. These active isolates were segregated into 6 genera using the internal transcribed spacer-large subunit (ITS-LSU) rDNA-sequence BLAST comparison. Four genera, Penicillium, Aspergillus, Mucor, and Chaetomium were the dominant taxa. A phylogenic tree illustrated their intergenera and intragenera genetic diversity. HPLC-DAD-HRMS analysis and subsequent database searching revealed that nine representative strains produced diverse bioactive compound profiles. These results detail the broad range of bioactive fungi found in a shark's gills, revealing their biopharmaceutical potential. To the best of our knowledge, this is the first study characterizing shark gill fungi and their bioactivity.

  13. Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

    Directory of Open Access Journals (Sweden)

    Jesús Zurdo

    2015-01-01

    Full Text Available In drug development, the “onus” of the low R&D efficiency has been put traditionally onto the drug discovery process (i.e., finding the right target or “binding” functionality. Here, we show that manufacturing is not only a central component of product success, but also that, by integrating manufacturing and discovery activities in a “holistic” interpretation of QbD methodologies, we could expect to increase the efficiency of the drug discovery process as a whole. In this new context, early risk assessment, using developability methodologies and computational methods in particular, can assist in reducing risks during development in a cost-effective way. We define specific areas of risk and how they can impact product quality in a broad sense, including essential aspects such as product efficacy and patient safety. Emerging industry practices around developability are introduced, including some specific examples of applications to biotherapeutics. Furthermore, we suggest some potential workflows to illustrate how developability strategies can be introduced in practical terms during early drug development in order to mitigate risks, reduce drug attrition and ultimately increase the robustness of the biopharmaceutical supply chain. Finally, we also discuss how the implementation of such methodologies could accelerate the access of new therapeutic treatments to patients in the clinic.

  14. Mini review: Recombinant production of tailored bio-pharmaceuticals in different Bacillus strains and future perspectives.

    Science.gov (United States)

    Lakowitz, Antonia; Godard, Thibault; Biedendieck, Rebekka; Krull, Rainer

    2018-05-01

    Bio-pharmaceuticals like antibodies, hormones and growth factors represent about one-fifth of commercial pharmaceuticals. Host candidates of growing interest for recombinant production of these proteins are strains of the genus Bacillus, long being established for biotechnological production of homologous and heterologous proteins. Bacillus strains benefit from development of efficient expression systems in the last decades and emerge as major industrial workhorses for recombinant proteins due to easy cultivation, non-pathogenicity and their ability to secrete recombinant proteins directly into extracellular medium allowing cost-effective downstream processing. Their broad product portfolio of pharmaceutically relevant recombinant proteins described in research include antibody fragments, growth factors, interferons and interleukins, insulin, penicillin G acylase, streptavidin and different kinases produced in various cultivation systems like microtiter plates, shake flasks and bioreactor systems in batch, fed-batch and continuous mode. To further improve production and secretion performance of Bacillus, bottlenecks and limiting factors concerning proteases, chaperones, secretion machinery or feedback mechanisms can be identified on different cell levels from genomics and transcriptomics via proteomics to metabolomics and fluxomics. For systematical identification of recurring patterns characteristic of given regulatory systems and key genetic targets, systems biology and omics-technology provide suitable and promising approaches, pushing Bacillus further towards industrial application for recombinant pharmaceutical protein production. Copyright © 2017. Published by Elsevier B.V.

  15. Oral delivery of human biopharmaceuticals, autoantigens and vaccine antigens bioencapsulated in plant cells.

    Science.gov (United States)

    Kwon, Kwang-Chul; Verma, Dheeraj; Singh, Nameirakpam D; Herzog, Roland; Daniell, Henry

    2013-06-15

    Among 12billion injections administered annually, unsafe delivery leads to >20million infections and >100million reactions. In an emerging new concept, freeze-dried plant cells (lettuce) expressing vaccine antigens/biopharmaceuticals are protected in the stomach from acids/enzymes but are released to the immune or blood circulatory system when plant cell walls are digested by microbes that colonize the gut. Vaccine antigens bioencapsulated in plant cells upon oral delivery after priming, conferred both mucosal and systemic immunity and protection against bacterial, viral or protozoan pathogens or toxin challenge. Oral delivery of autoantigens was effective against complications of type 1 diabetes and hemophilia, by developing tolerance. Oral delivery of proinsulin or exendin-4 expressed in plant cells regulated blood glucose levels similar to injections. Therefore, this new platform offers a low cost alternative to deliver different therapeutic proteins to combat infectious or inherited diseases by eliminating inactivated pathogens, expensive purification, cold storage/transportation and sterile injections. Copyright © 2012 Elsevier B.V. All rights reserved.

  16. Optimization of capillary zone electrophoresis for charge heterogeneity testing of biopharmaceuticals using enhanced method development principles.

    Science.gov (United States)

    Moritz, Bernd; Locatelli, Valentina; Niess, Michele; Bathke, Andrea; Kiessig, Steffen; Entler, Barbara; Finkler, Christof; Wegele, Harald; Stracke, Jan

    2017-12-01

    CZE is a well-established technique for charge heterogeneity testing of biopharmaceuticals. It is based on the differences between the ratios of net charge and hydrodynamic radius. In an extensive intercompany study, it was recently shown that CZE is very robust and can be easily implemented in labs that did not perform it before. However, individual characteristics of some examined proteins resulted in suboptimal resolution. Therefore, enhanced method development principles were applied here to investigate possibilities for further method optimization. For this purpose, a high number of different method parameters was evaluated with the aim to improve CZE separation. For the relevant parameters, design of experiments (DoE) models were generated and optimized in several ways for different sets of responses like resolution, peak width and number of peaks. In spite of product specific DoE optimization it was found that the resulting combination of optimized parameters did result in significant improvement of separation for 13 out of 16 different antibodies and other molecule formats. These results clearly demonstrate generic applicability of the optimized CZE method. Adaptation to individual molecular properties may sometimes still be required in order to achieve optimal separation but the set screws discussed in this study [mainly pH, identity of the polymer additive (HPC versus HPMC) and the concentrations of additives like acetonitrile, butanolamine and TETA] are expected to significantly reduce the effort for specific optimization. 2017 The Authors. Electrophoresis published by Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

  17. Initial cytotoxicity assays of media for sulfate-reducing bacteria: An endodontic biopharmaceutical product under development.

    Science.gov (United States)

    Heggendorn, Fabiano Luiz; Silva, Gabriela Cristina de Carvalho; Cardoso, Elisama Azevedo; Castro, Helena Carla; Gonçalves, Lúcio Souza; Dias, Eliane Pedra; Lione, Viviane de Oliveira Freitas; Lutterbach, Márcia Teresa Soares

    2016-01-01

    This study assessed the cell viability of the inoculation vehicle of BACCOR (a combination of sulfate-reducing bacteria plus a culture media for bacteria), a biopharmaceutical product under development for dental use as aid in fractured endodontic file removal from the root canal. Different culture media for bacteria were evaluated: modified Postgate E (MCP-E mod), Modified Postgate E without Agar-agar (MCP-E w/Ag), Postgate C with Agar-agar (MCP-C Ag) and Postgate C without Agar-agar (MCP-C w/Ag). Cytotoxicity was quantified by the MTT test, exposing L929 and Vero cell lines to the vehicles over 24 h. The exposure of L929 cell line to MCP-E w/Ag resulted in biocompatibility (52% cell viability), while the exposure of the Vero kidney line revealed only MCP-E mod as cytotoxic. When diluted, all the vehicles showed biocompatibility with both cell lines. MCP-E w/Ag was the vehicle chosen for BACCOR, because of its biocompatibility with the cells used.

  18. [Biopharmaceutics classification and absorption mechanisms primary study on four kinds of flavonoids].

    Science.gov (United States)

    Li, Hui-Fang; Zhang, Dong; Qu, Wen-Jun; Wang, Hai-Lin; Liu, Yang; Borjigdai, Almaz; Cui, Jian; Dong, Zheng-Qi

    2016-04-01

    The solubility and permeability on four kinds of flavonoids (kaempferol, hesperidin, apigenin, genistein) were test according to the theory of biopharmaceutics classification system (BCS), and their absorption mechanism. The solubility was investigated by the method in determination of solubility of "Chinese Pharmacopoeia 2010". To detect appearance permeability of compounds mentioned above, the appropriate concentrations were selected by the MTT method in cell transfer experiments in Caco-2 cell model, which established by in vitro cell culture method. Therefore, these compounds were classified with BCS according to solubility and permeability. In addition, to explore absorption mechanisms, the experiments in three different concentrations of compounds in high, medium and low in bidirectional transformation methods in Caco-2 cell model contacted. The study indicated that all of kaempferol, hesperidin, apigenin, genistein have the characteristics in low solubility and high permeability, which belong to BCSⅡ, and the absorption mechanism of kaempferol was active transportation. Whereas, hesperidin, apigenin, genistein were passive transportation. In this study, it carried out initial explorations on establishment of determination for solubility and permeability in flavonoids, and provided theoretical reference for further research on BCS in traditional Chinese medicine. Copyright© by the Chinese Pharmaceutical Association.

  19. The recognition of radiation protection training as a professional specialty

    International Nuclear Information System (INIS)

    Touzet, R. E.

    2003-01-01

    After Chernobyl accident, the radiation protection training was recognized as a professional specialty. To improve this training we focussed the project in 3 points: - The recognition of radiation protective in the legislation. - Stablishment of minimum programs - Different categories: nuclear facilities, radioisotopes and radiopharmaceuticals

  20. IPM of specialty crops and community gardens in north Florida

    Science.gov (United States)

    Insect pests post serious challenges to specialty crops (vegetables, fruits and nut crops) and community gardens in North Florida. The major vegetable pests include silverleaf whitefly, Bemisia argentifolii; the green peach aphid, Myzus persicae; southeastern green stinkbug, Nezara viridula; brown s...

  1. Assessing Student Interest and Familiarity with Professional Psychology Specialty Areas

    Science.gov (United States)

    Stark-Wroblewski, Kimberly; Wiggins, Tina L.; Ryan, Joseph J.

    2006-01-01

    The present study examined undergraduate psychology students' (N = 83) self-reported interest in and familiarity with five specialty areas in professional psychology: counseling psychology, clinical psychology, school psychology, forensic psychology, and criminal profiling. Results suggest that although students are quite interested in careers…

  2. The preference of radiology as a postgraduate medical specialty ...

    African Journals Online (AJOL)

    Background: Recruitment into medical specialties outside the core clinical departments remains a stumbling block to advancing medical practice in Nigeria. We set out to determine the factors influencing choice of diagnostic radiology as a field of specialization by the final year medical students in Usmanu Danfodiyo ...

  3. Personality and Values as Predictors of Medical Specialty Choice

    Science.gov (United States)

    Taber, Brian J.; Hartung, Paul J.; Borges, Nicole J.

    2011-01-01

    Research rarely considers the combined influence of personality traits and values in predicting behavioral outcomes. We aimed to advance a germinal line of inquiry that addresses this gap by separately and simultaneously examining personality traits and physician work values to predict medical specialty choice. First-year medical students (125…

  4. Knowledge of Medical House Officers about Dental Specialties ...

    African Journals Online (AJOL)

    Background: Some patients with oral diseases present initially to a general medical practitioner who is expected to refer the patients to the appropriate dental specialist for management. Thus they are expected to have a good knowledge of the different specialties in dentistry. This study was designed to determine the ...

  5. 76 FR 22733 - Cable Statutory License: Specialty Station List

    Science.gov (United States)

    2011-04-22

    ... Counsel, Copyright GC/I&R, P.O. Box 70400, Southwest Station, Washington, DC 20024. Telephone: (202) 707... foreign- language, religious, and/or automated programming in one-third of the hours of an average... programming comports with the 1981 FCC definition, and hence, qualifies it as a specialty station. 55 FR 40021...

  6. This Specialty Line of Clothing Really Is the "Bee's Knees"

    Science.gov (United States)

    Hollingsworth, Jan Carter

    2009-01-01

    This article features "Bee's Knees," a specialty line of clothing. While not the typical product one would think of when considering mobility equipment, this line of clothing certainly does aid in helping those with disabilities access their world more safely and comfortably. "Bee's Knees" offers pint-sized pants made of kid-friendly, durable…

  7. Burnout Comparison among Residents in Different Medical Specialties

    Science.gov (United States)

    Martini, Shahm; Arfken, Cynthia L.; Churchill, Amy; Balon, Richard

    2004-01-01

    Objective: To investigate resident burnout in relation to work and home-related factors. Method: Maslach Burnout Inventory was mailed to residents in eight different medical specialties, with a response rate of 35%. Results: Overall, 50% of residents met burnout criteria, ranging from 75% (obstetrics/gynecology) to 27% (family medicine). The first…

  8. 76 FR 42112 - Specialty Crop Committee Stakeholder Listening Sessions

    Science.gov (United States)

    2011-07-18

    ... Specialty Crop Committee Stakeholder Listening Sessions AGENCY: Research, Education, and Economics, USDA. ACTION: Notice of stakeholder listening sessions. SUMMARY: In accordance with the Federal Advisory Committee Act, 5 U.S.C. App 2, the United States Department of Agriculture announces two stakeholder...

  9. [Development of MEDUC-PG14 survey to assess postgraduate teaching in medical specialties].

    Science.gov (United States)

    Pizarro, Margarita; Solís, Nancy; Rojas, Viviana; Díaz, Luis Antonio; Padilla, Oslando; Letelier, Luz María; Aizman, Andrés; Sarfatis, Alberto; Olivos, Trinidad; Soza, Alejandro; Delfino, Alejandro; Latorre, Gonzalo; Ivanovic-Zuvic, Danisa; Hoyl, Trinidad; Bitran, Marcela; Arab, Juan Pablo; Riquelme, Arnoldo

    2015-08-01

    Feedback is one of the most important tools to improve teaching in medical education. To develop an instrument to assess the performance of clinical postgraduate teachers in medical specialties. A qualitative methodology consisting in interviews and focus-groups followed by a quantitative methodology to generate consensus, was employed. After generating the instrument, psychometric tests were performed to assess the construct validity (factor analysis) and reliability (Cronbach’s alpha). Experts in medical education, teachers and residents of a medical school participated in interviews and focus groups. With this information, 26 categories (79 items) were proposed and reduced to 14 items (Likert scale 1-5) by an expert’s Delphi panel, generating the MEDUC-PG14 survey, which was answered by 123 residents from different programs of medical specialties. Construct validity was carried out. Factor analysis showed three domains: Teaching and evaluation, respectful behavior towards patients and health care team, and providing feedback. The global score was 4.46 ± 0.94 (89% of the maximum). One teachers’ strength, as evaluated by their residents was “respectful behavior” with 4.85 ± 0.42 (97% of the maximum). “Providing feedback” obtained 4.09 ± 1.0 points (81.8% of the maximum). MEDUC-PG14 survey had a Cronbach’s alpha coefficient of 0.947. MEDUC-PG14 survey is a useful and reliable guide for teacher evaluation in medical specialty programs. Also provides feedback to improve educational skills of postgraduate clinical teachers.

  10. A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control.

    Science.gov (United States)

    Andrade, Cleyton Lage; Herrera, Miguel Angel De La O; Lemes, Elezer Monte Blanco

    2018-01-01

    One key quality control parameter for biopharmaceutical products is the analysis of residual cellular DNA. To determine small amounts of DNA (around 100 pg) that may be in a biologically derived drug substance, an analytical method should be sensitive, robust, reliable, and accurate. In principle, three techniques have the ability to measure residual cellular DNA: radioactive dot-blot, a type of hybridization; threshold analysis; and quantitative polymerase chain reaction. Quality risk management is a systematic process for evaluating, controlling, and reporting of risks that may affects method capabilities and supports a scientific and practical approach to decision making. This paper evaluates, by quality risk management, an alternative approach to assessing the performance risks associated with quality control methods used with biopharmaceuticals, using the tool hazard analysis and critical control points. This tool provides the possibility to find the steps in an analytical procedure with higher impact on method performance. By applying these principles to DNA analysis methods, we conclude that the radioactive dot-blot assay has the largest number of critical control points, followed by quantitative polymerase chain reaction, and threshold analysis. From the analysis of hazards (i.e., points of method failure) and the associated method procedure critical control points, we conclude that the analytical methodology with the lowest risk for performance failure for residual cellular DNA testing is quantitative polymerase chain reaction. LAY ABSTRACT: In order to mitigate the risk of adverse events by residual cellular DNA that is not completely cleared from downstream production processes, regulatory agencies have required the industry to guarantee a very low level of DNA in biologically derived pharmaceutical products. The technique historically used was radioactive blot hybridization. However, the technique is a challenging method to implement in a quality

  11. Perfusion seed cultures improve biopharmaceutical fed-batch production capacity and product quality.

    Science.gov (United States)

    Yang, William C; Lu, Jiuyi; Kwiatkowski, Chris; Yuan, Hang; Kshirsagar, Rashmi; Ryll, Thomas; Huang, Yao-Ming

    2014-01-01

    Volumetric productivity and product quality are two key performance indicators for any biopharmaceutical cell culture process. In this work, we showed proof-of-concept for improving both through the use of alternating tangential flow perfusion seed cultures coupled with high-seed fed-batch production cultures. First, we optimized the perfusion N-1 stage, the seed train bioreactor stage immediately prior to the production bioreactor stage, to minimize the consumption of perfusion media for one CHO cell line and then successfully applied the optimized perfusion process to a different CHO cell line. Exponential growth was observed throughout the N-1 duration, reaching >40 × 10(6) vc/mL at the end of the perfusion N-1 stage. The cultures were subsequently split into high-seed (10 × 10(6) vc/mL) fed-batch production cultures. This strategy significantly shortened the culture duration. The high-seed fed-batch production processes for cell lines A and B reached 5 g/L titer in 12 days, while their respective low-seed processes reached the same titer in 17 days. The shortened production culture duration potentially generates a 30% increase in manufacturing capacity while yielding comparable product quality. When perfusion N-1 and high-seed fed-batch production were applied to cell line C, higher levels of the active protein were obtained, compared to the low-seed process. This, combined with correspondingly lower levels of the inactive species, can enhance the overall process yield for the active species. Using three different CHO cell lines, we showed that perfusion seed cultures can optimize capacity utilization and improve process efficiency by increasing volumetric productivity while maintaining or improving product quality. © 2014 American Institute of Chemical Engineers.

  12. Strategic biopharmaceutical portfolio development: an analysis of constraint-induced implications.

    Science.gov (United States)

    George, Edmund D; Farid, Suzanne S

    2008-01-01

    Optimizing the structure and development pathway of biopharmaceutical drug portfolios are core concerns to the developer that come with several attached complexities. These include strategic decisions for the choice of drugs, the scheduling of critical activities, and the possible involvement of third parties for development and manufacturing at various stages for each drug. Additional complexities that must be considered include the impact of making such decisions in an uncertain environment. Presented here is the development of a stochastic multi-objective optimization framework designed to address these issues. The framework harnesses the ability of Bayesian networks to characterize the probabilistic structure of superior decisions via machine learning and evolve them to multi-objective optimality. Case studies that entailed three- and five-drug portfolios alongside a range of cash flow constraints were constructed to derive insight from the framework where results demonstrate that a variety of options exist for formulating nondominated strategies in the objective space considered, giving the manufacturer a range of pursuable options. In all cases limitations on cash flow reduce the potential for generating profits for a given probability of success. For the sizes of portfolio considered, results suggest that naïvely applying strategies optimal for a particular size of portfolio to a portfolio of another size is inappropriate. For the five-drug portfolio the most preferred means for development across the set of optimized strategies is to fully integrate development and commercial activities in-house. For the three-drug portfolio, the preferred means of development involves a mixture of in-house, outsourced, and partnered activities. Also, the size of the portfolio appears to have a larger impact on strategy and the quality of objectives than the magnitude of cash flow constraint.

  13. Molecular and biopharmaceutical investigation of alginate-inulin synbiotic coencapsulation of probiotic to target the colon.

    Science.gov (United States)

    Atia, Abdelbasset; Gomma, Ahmed I; Fliss, Ismail; Beyssac, Eric; Garrait, Ghislain; Subirade, Muriel

    2017-03-01

    Colon targeting, as a site-specific delivery for oral formulation, remains a major challenge, especially for sensitive bioactive components such as therapeutic forms of phages, live attenuated virus and prebiotics-probiotics association. Synbiotics could be used to protect encapsulated probiotics during the gastrointestinal tract and control their release in the colon. To achieve these goals, effective prebiotics, such as inulin, could be combined with alginate - the most exploited polymer used for probiotic encapsulation - in the form of beads. This work aimed to study the biopharmaceutical behaviour of alginate beads (A) and inulin-alginate beads of different inulin concentrations (5 or 20%) in 2% alginate (AI5, AI20). Beads were loaded with three probiotic strains (Pediococcus acidilactici Ul5, Lactobacillus reuteri and Lactobacillus salivarius). Dissolution of beads was studied by USP4 under conditions simulating the gastrointestinal condition. The survival rates of the bacterial strains were measured by a specific qPCR bacterial count. Mucoadhesiveness of beads was studied by an ex vivo method using intestinal mucosa. To understand the behaviour of each formulation, the ultrastructure of the polymeric network was studied using scanning electron microscopy (SEM). Molecular interactions between alginate and inulin were studied by Fourier transform infra-red spectroscopy (FTIR). Dissolution results suggested that the presence of inulin in beads provided more protection for the tested bacterial strains against the acidic pH. AI5 was the most effective formulation to deliver probiotics to the colon simulation conditions. FTIR and SEM investigations explained the differences in behaviour of each formula. The developed symbiotic form provided a promising matrix for the development of colonic controlled release systems.

  14. Biopharmaceutical Characterization and Bioavailability Study of a Tetrazole Analog of Clofibric Acid in Rat.

    Science.gov (United States)

    Vara-Gama, Nancy; Valladares-Méndez, Adriana; Navarrete-Vazquez, Gabriel; Estrada-Soto, Samuel; Orozco-Castellanos, Luis Manuel; Rivera-Leyva, Julio César

    2017-02-14

    In the current investigation, the physicochemical, biopharmaceutical and pharmacokinetic characterization of a new clofibric acid analog (Compound 1 ) was evaluated. Compound 1 showed affinity by lipophilic phase in 1 to 5 pH interval, indicating that this compound would be absorbed favorably in duodenum or jejunum. Also, Compound 1 possess two ionic species, first above of pH 4.43 and, the second one is present over pH 6.08. The apparent permeability in everted sac rat intestine model was 8.73 × 10 -6 cm/s in duodenum and 1.62 × 10 -5 cm/s in jejunum, suggesting that Compound 1 has low permeability. Elimination constant after an oral administration of 50 μg/kg in Wistar rat was 1.81 h -1 , absorption constant was 3.05 h -1 , C max was 3.57 μg/mL at 0.33 h, AUC 0-α was 956.54 μ/mL·h and distribution volume was 419.4 mL. To IV administration at the same dose, ke was 1.21 h -1 , Vd was 399.6 mL and AUC 0-α was 747.81 μ/mL·h. No significant differences were observed between pharmacokinetic parameters at every administration route. Bioavailability evaluated was 10.4%. Compound 1 is metabolized to Compound 2 probably by enzymatic hydrolysis, and it showed a half-life of 9.24 h. With these properties, Compound 1 would be considered as a prodrug of Compound 2 with potential as an antidiabetic and anti dyslipidemic agent.

  15. Biopharmaceutical Characterization and Bioavailability Study of a Tetrazole Analog of Clofibric Acid in Rat

    Directory of Open Access Journals (Sweden)

    Nancy Vara-Gama

    2017-02-01

    Full Text Available In the current investigation, the physicochemical, biopharmaceutical and pharmacokinetic characterization of a new clofibric acid analog (Compound 1 was evaluated. Compound 1 showed affinity by lipophilic phase in 1 to 5 pH interval, indicating that this compound would be absorbed favorably in duodenum or jejunum. Also, Compound 1 possess two ionic species, first above of pH 4.43 and, the second one is present over pH 6.08. The apparent permeability in everted sac rat intestine model was 8.73 × 10−6 cm/s in duodenum and 1.62 × 10−5 cm/s in jejunum, suggesting that Compound 1 has low permeability. Elimination constant after an oral administration of 50 μg/kg in Wistar rat was 1.81 h−1, absorption constant was 3.05 h−1, Cmax was 3.57 μg/mL at 0.33 h, AUC0–α was 956.54 μ/mL·h and distribution volume was 419.4 mL. To IV administration at the same dose, ke was 1.21 h−1, Vd was 399.6 mL and AUC0–α was 747.81 μ/mL·h. No significant differences were observed between pharmacokinetic parameters at every administration route. Bioavailability evaluated was 10.4%. Compound 1 is metabolized to Compound 2 probably by enzymatic hydrolysis, and it showed a half-life of 9.24 h. With these properties, Compound 1 would be considered as a prodrug of Compound 2 with potential as an antidiabetic and anti dyslipidemic agent.

  16. Provisional in-silico biopharmaceutics classification (BCS) to guide oral drug product development.

    Science.gov (United States)

    Wolk, Omri; Agbaria, Riad; Dahan, Arik

    2014-01-01

    The main objective of this work was to investigate in-silico predictions of physicochemical properties, in order to guide oral drug development by provisional biopharmaceutics classification system (BCS). Four in-silico methods were used to estimate LogP: group contribution (CLogP) using two different software programs, atom contribution (ALogP), and element contribution (KLogP). The correlations (r(2)) of CLogP, ALogP and KLogP versus measured LogP data were 0.97, 0.82, and 0.71, respectively. The classification of drugs with reported intestinal permeability in humans was correct for 64.3%-72.4% of the 29 drugs on the dataset, and for 81.82%-90.91% of the 22 drugs that are passively absorbed using the different in-silico algorithms. Similar permeability classification was obtained with the various in-silico methods. The in-silico calculations, along with experimental melting points, were then incorporated into a thermodynamic equation for solubility estimations that largely matched the reference solubility values. It was revealed that the effect of melting point on the solubility is minor compared to the partition coefficient, and an average melting point (162.7 °C) could replace the experimental values, with similar results. The in-silico methods classified 20.76% (± 3.07%) as Class 1, 41.51% (± 3.32%) as Class 2, 30.49% (± 4.47%) as Class 3, and 6.27% (± 4.39%) as Class 4. In conclusion, in-silico methods can be used for BCS classification of drugs in early development, from merely their molecular formula and without foreknowledge of their chemical structure, which will allow for the improved selection, engineering, and developability of candidates. These in-silico methods could enhance success rates, reduce costs, and accelerate oral drug products development.

  17. Solubility behavior and biopharmaceutical classification of novel high-solubility ciprofloxacin and norfloxacin pharmaceutical derivatives.

    Science.gov (United States)

    Breda, Susana A; Jimenez-Kairuz, Alvaro F; Manzo, Ruben H; Olivera, María E

    2009-04-17

    The hydrochlorides of the 1:3 aluminum:norfloxacin and aluminum:ciprofloxacin complexes were characterized according to the Biopharmaceutics Classification System (BCS) premises in comparison with their parent compounds. The pH-solubility profiles of the complexes were experimentally determined at 25 and 37 degrees C in the range of pH 1-8 and compared to that of uncomplexed norfloxacin and ciprofloxacin. Both complexes are clearly more soluble than the antibiotics themselves, even at the lowest solubility pHs. The increase in solubility was ascribed to the species controlling solubility, which were analyzed in the solid phases at equilibrium at selected pHs. Additionally, permeability was set as low, based on data reported in the scientific literature regarding oral bioavailability, intestinal and cell cultures permeabilities and also considering the influence of stoichiometric amounts of aluminum. The complexes fulfill the BCS criterion to be classified as class 3 compounds (high solubility/low permeability). Instead, the active pharmaceutical ingredients (APIs) currently used in solid dosage forms, norfloxacin and ciprofloxacin hydrochloride, proved to be BCS class 4 (low solubility/low permeability). The solubility improvement turns the complexes as potential biowaiver candidates from the scientific point of view and may be a good way for developing more dose-efficient formulations. An immediate release tablet showing very rapid dissolution was obtained. Its dissolution profile was compared to that of the commercial ciprofloxacin hydrochloride tablets allowing to dissolution of the complete dose at a critical pH such as 6.8.

  18. Interventional radiology as clinical specialty and how this affects the radiology specialty as a whole

    International Nuclear Information System (INIS)

    Tsetis, D.

    2015-01-01

    maintain high quality clinical standards, Radiology departments must carry out regular audit and where available submitting data to national or international registries. Furthermore, IRs have a duty of care to ensure that the IR procedures are safe and effective which can only be demonstrated by high quality research. For IR to survive as clinical specialty, IR training must be adapted in order to ensure that future IR’s will acquire both clinical knowledge and confidence in the disease processes as well as in dealing with patients. Core IR training must include communication skills, clinical assessment and knowledge of the various alternative treatments to IR both surgical and medical. In order to fulfill these expectations, IR training must move to a certified residency program; an attractive format would be one year of internship, three years of Diagnostic Radiology, and then two years of IR. this IR certification will hopefully have a huge impact on local organizational issues so that at a local institution the IR service will be listed next to surgery and medicine. towards this direction, appropriate curricula and formal assessment of the appropriate skills such as the european Board of Interventional Radiology (eBIR) examination are available to ensure the high standards of the future IR workforce. the CIRSe Clinical Practice in IR Manual provides a comprehensive approach to patient care, including numerous well-structured forms for gathering data on patient or social history and conducting examinations are part of its content (www.cirse.org/Clinical_Practice) In my opinion the continuous effort to upgrade IR practice, also points to the only direction for the entire Radiology specialty to survive: the radiologist should be part of clinical decision-making, a true active clinical partner, with up-to-date clinical knowledge about a medical subspecialty. the reality is that clinicians have started to learn about the images in their subspecialty territory, and through

  19. 75 FR 34418 - Notice of the Specialty Crop Committee's Stakeholder Listening Session

    Science.gov (United States)

    2010-06-17

    ... Notice of the Specialty Crop Committee's Stakeholder Listening Session AGENCY: Research, Education, and Economics, USDA. ACTION: Notice of stakeholder listening session. SUMMARY: The notice announces the Specialty Crop Committee's Stakeholder Listening Session. The document contained the wrong date for the...

  20. pH-Dependent solubility and permeability criteria for provisional biopharmaceutics classification (BCS and BDDCS) in early drug discovery.

    Science.gov (United States)

    Varma, Manthena V; Gardner, Iain; Steyn, Stefanus J; Nkansah, Paul; Rotter, Charles J; Whitney-Pickett, Carrie; Zhang, Hui; Di, Li; Cram, Michael; Fenner, Katherine S; El-Kattan, Ayman F

    2012-05-07

    The Biopharmaceutics Classification System (BCS) is a scientific framework that provides a basis for predicting the oral absorption of drugs. These concepts have been extended in the Biopharmaceutics Drug Disposition Classification System (BDDCS) to explain the potential mechanism of drug clearance and understand the effects of uptake and efflux transporters on absorption, distribution, metabolism, and elimination. The objective of present work is to establish criteria for provisional biopharmaceutics classification using pH-dependent passive permeability and aqueous solubility data generated from high throughput screening methodologies in drug discovery settings. The apparent permeability across monolayers of clonal cell line of Madin-Darby canine kidney cells, selected for low endogenous efflux transporter expression, was measured for a set of 105 drugs, with known BCS and BDDCS class. The permeability at apical pH 6.5 for acidic drugs and at pH 7.4 for nonacidic drugs showed a good correlation with the fraction absorbed in human (Fa). Receiver operating characteristic (ROC) curve analysis was utilized to define the permeability class boundary. At permeability ≥ 5 × 10(-6) cm/s, the accuracy of predicting Fa of ≥ 0.90 was 87%. Also, this cutoff showed more than 80% sensitivity and specificity in predicting the literature permeability classes (BCS), and the metabolism classes (BDDCS). The equilibrium solubility of a subset of 49 drugs was measured in pH 1.2 medium, pH 6.5 phosphate buffer, and in FaSSIF medium (pH 6.5). Although dose was not considered, good concordance of the measured solubility with BCS and BDDCS solubility class was achieved, when solubility at pH 1.2 was used for acidic compounds and FaSSIF solubility was used for basic, neutral, and zwitterionic compounds. Using a cutoff of 200 μg/mL, the data set suggested a 93% sensitivity and 86% specificity in predicting both the BCS and BDDCS solubility classes. In conclusion, this study identified

  1. Specialty Drug Spending Trends Among Medicare And Medicare Advantage Enrollees, 2007–11

    OpenAIRE

    Trish, Erin; Joyce, Geoffrey; Goldman, Dana P.

    2014-01-01

    Specialty pharmaceuticals include most injectable and biologic agents used to treat complex conditions such as rheumatoid arthritis, multiple sclerosis, and cancer. We analyzed trends in specialty drug spending among Medicare beneficiaries ages sixty-five and older using 2007–11 pharmacy claims data from a 20 percent sample of Medicare beneficiaries. Annual specialty drug spending per beneficiary who used specialty drugs increased considerably during the study period, from $2,641 to $8,976. H...

  2. Implementation of a Cross-specialty Training Program in Basic Laparoscopy

    DEFF Research Database (Denmark)

    Bjerrum, Flemming; Sorensen, Jette Led; Thinggaard, Jette

    2015-01-01

    BACKGROUND AND OBJECTIVES: Several surgical specialties use laparoscopy and share many of the same techniques and challenges, such as entry approaches, equipment, and complications. However, most basic training programs focus on a single specialty. The objective of this study was to describe the ...... laparoscopy is feasible. There are several logistic benefits of using a cross-specialty approach; however, it is important that local departments include specialty-specific components, together with clinical departmental follow-up....

  3. The value of independent specialty designation for interventional cardiology.

    Science.gov (United States)

    Blankenship, James C; Powell, Wayne A; Gray, Dawn R; Duffy, Peter L

    2017-01-01

    Interventional cardiology has finally completed, after 26 years of advocacy, a professional hat trick: independent board certification, membership as a unique specialty in the American Medical Association House of Delegates (AMA HOD), and recognition by the Centers for Medicaid and Medicare Services (CMS) as a separate medical specialty. This article points out how these distinctions for interventional cardiology and its professional society, the Society for Cardiovascular Angiography and Interventions (SCAI), have led to clear and definite benefits for interventional cardiologists and their patients. We focus on the least understood of these three-recognition by CMS and its implications for reimbursement and quality assessment for interventional cardiologists. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  4. An analysis of the medical specialty training system in Spain.

    Science.gov (United States)

    Freire, José-Manuel; Infante, Alberto; de Aguiar, Adriana Cavalcanti; Carbajo, Pilar

    2015-06-02

    In this paper, we analyse the medical specialty training system in Spain (the so-called "residency system"). In order to do so, we a) summarize its historical evolution; b) describe the five major architectural pillars on which the system is currently based; c) analyse the special contract of the specialist-in-training; d) discuss the three major challenges for the medical specialist training future: the evolution and expansion of the residency system to other health professions, the issue of grouping specialties with a common core trunk and the continuity of the learning process; and e) draw four conclusions that may be relevant for those who are in the process of developing or revising their own medical specialization systems.

  5. [A historical view of the specialty of clinical microbiology].

    Science.gov (United States)

    Pérez, Evelio Perea; Álvarez, Rogelio Martín

    2010-10-01

    Clinical microbiology today is a well established specialty in Spain whose development has necessarily been linked to improvements in the diagnosis, treatment and prevention of infectious diseases. Over time, clinical, teaching, and research structures have been organized around these diseases. In addition, a scientific society for specialists in infectious diseases (Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica) has been set up, which in turn, publishes the journal ENFERMEDADES INFECCIOSAS Y MICROBIOLOGÍA CLÍNICA, and organizes congresses, meetings, working groups and a quality control program, etc. Clinical microbiologists will continue to be needed to meet future challenges (identification of new pathogenic microorganisms, methodological changes, diagnostic quality and speed, nosocomial infections, the development of antimicrobial resistance, etc.), which constitute a well-defined area of knowledge specific to our specialty. Copyright © 2010 Elsevier España S.L. All rights reserved.

  6. Gender inflexion in the construction of a new medical specialty

    Directory of Open Access Journals (Sweden)

    Rachel Aisengart Menezes

    2008-01-01

    Full Text Available This article presents the constitution of a new medical specialty, Palliative Care, directed to patients "out of therapeutic possibilities". The concept emerged around 1960 in England and was implemented in Brazil a couple of years before 1990. It is characterized by an active attendance of the dying process. It postulates a "spiritual assistance" to the patient and his/her family members, including the emotional universe. Ethnographical observation and interviews with Brazilian professionals showed a majority of women among the health teams involved in this proposal. This article discusses and analyses the connection between the construction of the specialty and gender representation among these professionals that reflects popular social images about death, beliefs, emotions and the roles played by women and men in these subjects.

  7. Gender Inflexion in the Construction of a New Medical Specialty

    Directory of Open Access Journals (Sweden)

    Rachel Aisengart Menezes

    2007-09-01

    Full Text Available This article presents the constitution of a new medical specialty, Palliative Care, directed to patients “out of therapeutic possibilities”. The concept emerged around 1960 in England and was implemented in Brazil a couple of years before 1990. It is characterized by an active attendance of the dying process. It postulates a “spiritual assistance” to the patient and his/her family members, including the emotional universe. Ethnographical observation and interviews with Brazilian professionals showed a majority of women among the health teams involved in this proposal. This article discusses and analyses the connection between the construction of the specialty and gender representation among these professionals that reflects popular social images about death, beliefs, emotions and the roles played by women and men in these subjects.

  8. 77 FR 40644 - Specialty Bar Products Company; A Subsidiary of Doncasters, Inc., Blairsville, PA; Notice of...

    Science.gov (United States)

    2012-07-10

    ... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-80,511] Specialty Bar Products... Application for Reconsideration for the workers and former workers of Specialty Bar Products Company, a... resulted in reduction of work force within Specialty Bar Products.'' Information obtained during the...

  9. 76 FR 2148 - Specialty Minerals, Inc., Franklin, VA; Notice of Revised Determination on Reconsideration

    Science.gov (United States)

    2011-01-12

    ... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-74,057] Specialty Minerals, Inc...) applicable to workers of Specialty Minerals, Inc., Franklin, Virginia (the subject firm). The Notice was... workers of Specialty Minerals, Inc., Franklin, Virginia, who are engaged in employment related to the...

  10. Factors considered by undergraduate medical students when selecting specialty of their future careers.

    Science.gov (United States)

    Alawad, Awad Ali Mohamed Ahmed; Khan, Waleed Shabeer; Abdelrazig, Yousif Mohammed; Elzain, Yamin Ibrahim; Khalil, Hassan Osman; Ahmed, Omer Bakri Elsayed; Adam, Omeralfaroug Ahmed Ibrahim

    2015-01-01

    Medical students are the source of a country's physicians. Determining how medical students select their areas of specialization is the key to achieve a balanced distribution of doctors among all specialties. The objective is to identify the number of medical students who have decided their postgraduate specialty career, their career specialties preference, and factors that may influence their decision to select a particular specialty. A facility based cross-sectional study was conducted in September 2013 at Faculty of Medicine, University of Medical Sciences and Technology, Khartoum, Sudan. A self-administered semi-structured questionnaire comprising demographic data and questions about future specialties preferences and factors influencing those preferences was distributed to 887 male and female students, (from first to fifth academic years) recruited in the study. Response rate was 73% with 647 questionnaires collected, out of 887 eligible medical students. Of the returned questionnaires, 604 were valid. The majority of students (541, 89.6%) have chosen a specialty. Surgery, medicine, paediatrics and obstetrics and gynecology were the most selected specialties. The least selected specialty was anaesthesiology. A significant association was found between gender and specialty choice using Chi-square test (p = 0.00). There was no association between undergraduate level and specialty choice (p = 0.633). The most common reason for choosing a specific specialty was "Personal Interest" (215, 39.7%) followed by being "Helpful to the community" (144, 26.6%). Surgery, medicine, paediatrics and obstetrics and gynecology were the most selected specialties.

  11. 76 FR 45397 - Export Inspection and Weighing Waiver for High Quality Specialty Grain Transported in Containers

    Science.gov (United States)

    2011-07-29

    ...-AB18 Export Inspection and Weighing Waiver for High Quality Specialty Grain Transported in Containers... permanent a waiver due to expire on July 31, 2012, for high quality specialty grain exported in containers... of high quality specialty grain exported in containers are small entities that up until recently...

  12. The impact of clerkships on students' specialty preferences: what do undergraduates learn for their profession?

    NARCIS (Netherlands)

    Maiorova, T.; Stevens, F.; Scherpbier, A.; Zee, J. van der

    2008-01-01

    OBJECTIVE: Clinical experiences and gender have been shown to influence medical students' specialty choices. It remains unclear, however, which aspects of experiences make students favour some specialties and reject others. This study aimed to clarify the effects of clerkships on specialty choice

  13. The Price Elasticity of Specialty Drug Use: Evidence from Cancer Patients in Medicare Part D.

    Science.gov (United States)

    Jung, Jeah Kyoungrae; Feldman, Roger; McBean, A Marshall

    2017-12-01

    Specialty drugs can bring substantial benefits to patients with debilitating conditions, such as cancer, but their costs are very high. Insurers/payers have increased patient cost-sharing for specialty drugs to manage specialty drug spending. We utilized Medicare Part D plan formulary data to create the initial price (cost-sharing in the initial coverage phase in Part D), and estimated the total demand (both on- and off-label uses) for specialty cancer drugs among elderly Medicare Part D enrollees with no low-income subsidies (non-LIS) as a function of the initial price. We corrected for potential endogeneity associated with plan choice by instrumenting the initial price of specialty cancer drugs with the initial prices of specialty drugs in unrelated classes. We report three findings. First, we found that elderly non-LIS beneficiaries with cancer were less likely to use a Part D specialty cancer drug when the initial price was high: the overall price elasticity of specialty cancer drug spending ranged between -0.72 and -0.75. Second, the price effect in Part D specialty cancer drug use was not significant among newly diagnosed patients. Finally, we found that use of Part B-covered cancer drugs was not responsive to the Part D specialty cancer drug price. As the demand for costly specialty drugs grows, it will be important to identify clinical circumstances where specialty drugs can be valuable and ensure access to high-value treatments.

  14. Information Security: A Scientometric Study of the Profile, Structure, and Dynamics of an Emerging Scholarly Specialty

    Science.gov (United States)

    Olijnyk, Nicholas Victor

    2014-01-01

    The central aim of the current research is to explore and describe the profile, dynamics, and structure of the information security specialty. This study's objectives are guided by four research questions: 1. What are the salient features of information security as a specialty? 2. How has the information security specialty emerged and evolved from…

  15. 78 FR 60766 - Clarification on Fireworks Policy Regarding Approvals or Certifications for Specialty Fireworks...

    Science.gov (United States)

    2013-10-02

    ... 173 [Docket No. PHMSA-2013-0206; Notice No. 13-15] Clarification on Fireworks Policy Regarding Approvals or Certifications for Specialty Fireworks Devices AGENCY: Pipeline and Hazardous Materials Safety... applications for specialty fireworks devices. Specialty fireworks devices are fireworks devices in various...

  16. Lipid components and oxidative status of selected specialty oils

    Energy Technology Data Exchange (ETDEWEB)

    Madawala, S. R. P.; Kochhar, S. P.; Dutta, P. C.

    2012-11-01

    Many vegetable oils are marketed as specialty oils because of their retained flavors, tastes and distinct characteristics. Specialty oil samples which were commercially produced and retailed were purchased from local superstores in Reading, UK, and Uppsala, Sweden and profiled for detailed lipid composition and oxidative status. These oil samples include: almond, hazelnut, walnut, macadamia nut, argan, avocado, grape seed, roasted sesame, rice bran, cold pressed, organic and cold pressed, warm pressed and refined rapeseed oils. The levels of PV were quite low (0.5-1.3mEq O{sub 2}/kg) but AV and Rancimat values at 100 degree centigrade (except for rapeseed oils) varied considerably at (0.5-15.5) and (4.2-37.0 h) respectively. Macadamia nut oil was found to be the most stable oil followed by argan oil, while walnut oil was the least stable. Among the specialty oils, macadamia nut oil had the lowest (4%) and walnut oil had the highest (71%) level of total PUFA. The organic cold pressed rapeseed oil had considerably lower PUFA (27%) compared with other rapeseed oils (28- 35%). In all the samples, {alpha}- and {gamma}- tocopherols were the major tocopherols; nut oils had generally lower levels. Total sterols ranged from 889 to 15,106 {mu}g/g oil. The major sterols were {beta}-sitosterol (61-85%) and campesterol (6-20%). Argan oil contained schottenol (35%) and spinasterol (32%). Compared with literature values, no marked differences were observed among the differently processed, organically grown or cold pressed rapeseed oils and other specialty oils in this study. (Author) 33 refs.

  17. Benchmarking specialty hospitals, a scoping review on theory and practice.

    Science.gov (United States)

    Wind, A; van Harten, W H

    2017-04-04

    Although benchmarking may improve hospital processes, research on this subject is limited. The aim of this study was to provide an overview of publications on benchmarking in specialty hospitals and a description of study characteristics. We searched PubMed and EMBASE for articles published in English in the last 10 years. Eligible articles described a project stating benchmarking as its objective and involving a specialty hospital or specific patient category; or those dealing with the methodology or evaluation of benchmarking. Of 1,817 articles identified in total, 24 were included in the study. Articles were categorized into: pathway benchmarking, institutional benchmarking, articles on benchmark methodology or -evaluation and benchmarking using a patient registry. There was a large degree of variability:(1) study designs were mostly descriptive and retrospective; (2) not all studies generated and showed data in sufficient detail; and (3) there was variety in whether a benchmarking model was just described or if quality improvement as a consequence of the benchmark was reported upon. Most of the studies that described a benchmark model described the use of benchmarking partners from the same industry category, sometimes from all over the world. Benchmarking seems to be more developed in eye hospitals, emergency departments and oncology specialty hospitals. Some studies showed promising improvement effects. However, the majority of the articles lacked a structured design, and did not report on benchmark outcomes. In order to evaluate the effectiveness of benchmarking to improve quality in specialty hospitals, robust and structured designs are needed including a follow up to check whether the benchmark study has led to improvements.

  18. Meta-Analysis of Surgeon Burnout Syndrome and Specialty Differences.

    Science.gov (United States)

    Bartholomew, Alex J; Houk, Anna K; Pulcrano, Marisa; Shara, Nawar M; Kwagyan, John; Jackson, Patrick G; Sosin, Michael

    2018-02-27

    Surgeon burnout compromises the quality of life of physicians and the delivery of care to patients. Burnout rates and interpretation of the Maslach Burnout Inventory (MBI) complicates the interpretation of surgeon burnout. The purpose of this study is to apply a standardized interpretation of severe surgeon burnout termed, "burnout syndrome" to analyze inherent variation within surgical specialties. A systematic literature search was performed using MEDLINE, PsycINFO, and EMBASE to identify studies reporting MBI data by surgical specialty. Data extraction was performed to isolate surgeon specific data. A meta-analysis was performed. A total of 16 cross-sectional studies were included in this meta-analysis, totaling 3581 subjects. A random effects model approximated burnout syndrome at 3.0% (95% CI: 2.0%-5.0%; I 2 = 78.1%). Subscale analysis of emotional exhaustion, depersonalization, and personal accomplishment indicated subscale burnout in 30.0% (CI: 25.0%-36.0%; I 2 = 93.2%), 34.0% (CI: 25.0%-43.0%; I 2 = 96.9%), and 25.0% (CI: 18.0%-32.0%; I 2 = 96.5%) of surgeons, respectively. Significant differences (p burnout termed "burnout syndrome," although surgeon burnout may occur in up to 34% of surgeons, characterized by high burnout in 1 of 3 subscales. Surgical specialties have significantly different rates of burnout subscales. Future burnout studies should target the specialty-specific level to understand inherent differences in an effort to better understand methods of improving surgeon burnout. Copyright © 2018 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  19. Protein A affinity chromatography of Chinese hamster ovary (CHO) cell culture broths containing biopharmaceutical monoclonal antibody (mAb): Experiments and mechanistic transport, binding and equilibrium modeling.

    Science.gov (United States)

    Grom, Matic; Kozorog, Mirijam; Caserman, Simon; Pohar, Andrej; Likozar, Blaž

    2018-04-15

    Protein A-based affinity chromatography is a highly-efficient separation method to capture, purify and isolate biosimilar monoclonal antibodies (mAb) - an important medical product of biopharmaceutical industrial manufacturing. It is considered the most expensive step in purification downstream operations; therefore, its performance optimization offers a great cost saving in the overall production expenditure. The biochemical mixture-separating specific interaction experiments with Chinese hamster ovary (CHO) cell culture harvest, containing glycosylated extracellular immunoglobulins (Ig), were made using five different state-of-the-art commercial resins. Packing breakthrough curves were recorded at an array of prolonged residence times. A mathematical simulation model was developed, applied and validated in combination with non-linear regression algorithms on bed effluent concentrations to determine the previously-unknown binding properties of stationary phase materials. Apart from the columns' differential partitioning, the whole external system was also integrated. It was confirmed that internal pore diffusion is the global rate-limiting resistance of the compound retention process. Immobilizing substrate characteristics, obtained in this engineering study, are indispensable for the scale-up of the periodic counter-current control with mechanistic load, elution and wash reduction. Furthermore, unit's volumetric flow screening measurements revealed dynamic effect correlation to eluate quality parameters, like the presence of aggregates, the host cell-related impurities at supernatant's extended feeding, and titre. Numerical sensitivity outputs demonstrated the impacts of fluidics (e.g. axial dispersion coefficient), thermodynamics (Langmuir adsorption) and mass transfer fluxes. Copyright © 2018 Elsevier B.V. All rights reserved.

  20. Topical anaesthesia in children: reducing the need for specialty referral.

    LENUS (Irish Health Repository)

    O'Connor, Gabrielle

    2012-01-31

    OBJECTIVE: The management of wounds in children is stressful, not only for the child, but also for parents and staff. In our Emergency Department (ED), we currently do not have a paediatric sedation policy, and thus children requiring suturing, not amenable to distraction and infiltrative anaesthesia, are referred to specialty teams for general anaesthesia. We proposed that the introduction of a topical anaesthetic gel (lidocaine, adrenaline, tetracaine - LAT) might help to reduce the number of referrals, by allowing the ED staff to perform the procedures, in combination with nonpharmacological approaches. METHODS: We carried out a retrospective review of ED records of all children aged 14 years or less attending with wounds, over an 8-month period, from 01 May 2007 to 31 January 2008. RESULTS: Two hundred and one (50.6%) patients presented before the introduction of LAT gel, whereas 196 (49.3%) patients presented afterwards. A total of 39 (19.4%) patients were referred for specialty review pre-LAT, whereas only 19 (9.7%) patients were referred in the LAT group. Of these, 31 (15.4%) pre-LAT and 15 (7.7%) LAT group required general anaesthesia. There is a significant difference between these two groups, using Fischer\\'s exact test, P=0.018. CONCLUSION: We have found that the introduction of topical anaesthetic gel in ED has significantly reduced the number of children with wounds referred to specialty teams for general anaesthesia. This has important implications for patient safety and hospital resources.

  1. Evaluation of feedback given to trainees in medical specialties.

    Science.gov (United States)

    Tham, Tony Ck; Burr, Bill; Boohan, Mairead

    2017-07-01

    The aim of this study was to evaluate the quality of feedback provided to specialty trainees (ST3 or higher) in medical specialties during their workplace-based assessments (WBAs). The feedback given in WBAs was examined in detail in a group of 50 ST3 or higher trainees randomly selected from those taking part in a pilot study of changes to the WBA system conducted by the Joint Royal Colleges of Physicians Training Board. They were based in Health Education Northeast (Northern Deanery) and Health Education East of England (Eastern Deanery). Thematic analysis was used to identify commonly occurring themes. Feedback was mainly positive but there were differences in quality between specialties. Problems with feedback included insufficient detail, such that it was not possible to map the progression of the trainee, insufficient action plans made and the timing of feedback not being contemporaneous (feedback not being given at the time of assessment). Recommendations included feedback should be more specific; there need to be more options in the feedback forms for the supervisor to compare the trainee's performance to what is expected and action plans need to be made. © Royal College of Physicians 2017. All rights reserved.

  2. Shale oil specialty markets: Screening survey for United States applications

    Energy Technology Data Exchange (ETDEWEB)

    1987-12-01

    EG and G requested J. E. Sinor Consultants Inc. to carry out an initial screening study on the possibilities for producing specialty chemicals from oil shale. Raw shale oil is not an acceptable feedstock to refineries and there are not enough user of heavy fuel oil in the western oil shale region to provide a dependable market. The only alternatives are to hydrotreat the oil, or else ship it long distances to a larger market area. Either of these alternatives results in a cost penalty of several dollars per barrel. Instead of attempting to enter the large-volume petroleum products market, it was hypothesized that a small shale oil facility might be able to produce specialty chemicals with a high enough average value to absorb the high costs of shipping small quantities to distant markets and still provide a higher netback to the plant site than sales to the conventional petroleum products market. This approach, rather than attempting to refine shale oil or to modify its characteristics to satisfy the specifications for petroleum feedstocks or products, focuses instead on those particular characteristics which distinguish shale oil from petroleum, and attempts to identify applications which would justify a premium value for those distinctive characteristics. Because byproducts or specialty chemicals production has been a prominent feature of oil shale industries which have flourished for periods of time in various countries, a brief review of those industries provides a starting point for this study. 9 figs., 32 tabs.

  3. Fostering Change from Within: Influencing Teaching Practices of Departmental Colleagues by Science Faculty with Education Specialties.

    Science.gov (United States)

    Bush, Seth D; Rudd, James A; Stevens, Michael T; Tanner, Kimberly D; Williams, Kathy S

    2016-01-01

    Globally, calls for the improvement of science education are frequent and fervent. In parallel, the phenomenon of having Science Faculty with Education Specialties (SFES) within science departments appears to have grown in recent decades. In the context of an interview study of a randomized, stratified sample of SFES from across the United States, we discovered that most SFES interviewed (82%) perceived having professional impacts in the realm of improving undergraduate science education, more so than in research in science education or K-12 science education. While SFES reported a rich variety of efforts towards improving undergraduate science education, the most prevalent reported impact by far was influencing the teaching practices of their departmental colleagues. Since college and university science faculty continue to be hired with little to no training in effective science teaching, the seeding of science departments with science education specialists holds promise for fostering change in science education from within biology, chemistry, geoscience, and physics departments.

  4. Medical student debt and major life choices other than specialty

    Directory of Open Access Journals (Sweden)

    James Rohlfing

    2014-11-01

    Full Text Available Background: Median indebtedness at graduation is now more than $170,000 for graduates of US Medical Schools. Debate still exists as to whether higher debt levels influence students to choose high paying non-primary care specialties. Notably, no previous research on the topic has taken into account cost of attendance when constructing a debt model, nor has any research examined the non-career major life decisions that medical students face. Methods: Medical students were surveyed using an anonymous electronic instrument developed for this study. The survey was delivered through a link included in a study email and students were recruited from school wide listservs and through snowball sampling (students were encouraged to share a link to the survey with other medical students. No incentives were offered for survey completion. Results: Responses were recorded from 102 US Allopathic medical schools (n=3,032, with 22 institutions (11 public, 11 private meeting inclusion criteria of 10% student body response proportion (n=1,846. Students with higher debt relative to their peers at their home institution reported higher frequencies of feeling callous towards others, were more likely to choose a specialty with a higher average annual income, were less likely to plan to practice in underserved locations, and were less likely to choose primary care specialties. Students with higher aggregate amounts of medical student loan debt were more likely to report high levels of stress from their educational debt, to delay getting married and to report disagreement that they would choose to become a physician again, if given the opportunity to revisit that choice. Increases in both aggregate and relative debt were associated with delaying having children, delaying buying a house, concerns about managing and paying back educational debt, and worrying that educational debt will influence one's specialty choice. Conclusions: Medical student debt and particularly debt

  5. Medical student debt and major life choices other than specialty.

    Science.gov (United States)

    Rohlfing, James; Navarro, Ryan; Maniya, Omar Z; Hughes, Byron D; Rogalsky, Derek K

    2014-01-01

    Median indebtedness at graduation is now more than $170,000 for graduates of US Medical Schools. Debate still exists as to whether higher debt levels influence students to choose high paying non-primary care specialties. Notably, no previous research on the topic has taken into account cost of attendance when constructing a debt model, nor has any research examined the non-career major life decisions that medical students face. Medical students were surveyed using an anonymous electronic instrument developed for this study. The survey was delivered through a link included in a study email and students were recruited from school wide listservs and through snowball sampling (students were encouraged to share a link to the survey with other medical students). No incentives were offered for survey completion. Responses were recorded from 102 US Allopathic medical schools (n=3,032), with 22 institutions (11 public, 11 private) meeting inclusion criteria of 10% student body response proportion (n=1,846). Students with higher debt relative to their peers at their home institution reported higher frequencies of feeling callous towards others, were more likely to choose a specialty with a higher average annual income, were less likely to plan to practice in underserved locations, and were less likely to choose primary care specialties. Students with higher aggregate amounts of medical student loan debt were more likely to report high levels of stress from their educational debt, to delay getting married and to report disagreement that they would choose to become a physician again, if given the opportunity to revisit that choice. Increases in both aggregate and relative debt were associated with delaying having children, delaying buying a house, concerns about managing and paying back educational debt, and worrying that educational debt will influence one's specialty choice. Medical student debt and particularly debt relative to peers at the same institution appears to

  6. The Biopharmaceutics Classification System: subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC.

    Science.gov (United States)

    Tsume, Yasuhiro; Mudie, Deanna M; Langguth, Peter; Amidon, Greg E; Amidon, Gordon L

    2014-06-16

    The Biopharmaceutics Classification System (BCS) has found widespread utility in drug discovery, product development and drug product regulatory sciences. The classification scheme captures the two most significant factors influencing oral drug absorption; solubility and intestinal permeability and it has proven to be a very useful and a widely accepted starting point for drug product development and drug product regulation. The mechanistic base of the BCS approach has, no doubt, contributed to its wide spread acceptance and utility. Nevertheless, underneath the simplicity of BCS are many detailed complexities, both in vitro and in vivo which must be evaluated and investigated for any given drug and drug product. In this manuscript we propose a simple extension of the BCS classes to include sub-specification of acid (a), base (b) and neutral (c) for classes II and IV. Sub-classification for Classes I and III (high solubility drugs as currently defined) is generally not needed except perhaps in border line solubility cases. It is well known that the , pKa physical property of a drug (API) has a significant impact on the aqueous solubility dissolution of drug from the drug product both in vitro and in vivo for BCS Class II and IV acids and bases, and is the basis, we propose for a sub-classification extension of the original BCS classification. This BCS sub-classification is particularly important for in vivo predictive dissolution methodology development due to the complex and variable in vivo environment in the gastrointestinal tract, with its changing pH, buffer capacity, luminal volume, surfactant luminal conditions, permeability profile along the gastrointestinal tract and variable transit and fasted and fed states. We believe this sub-classification is a step toward developing a more science-based mechanistic in vivo predictive dissolution (IPD) methodology. Such a dissolution methodology can be used by development scientists to assess the likelihood of a

  7. [Effect of multicomponent environment on intestinal permeability of puerarin in biopharmaceutics classification system of Chinese materia medica].

    Science.gov (United States)

    Liu, Yang; Wang, Gang; Dong, Ling; Tang, Ming-Min; Zhu, Mei-Ling; Dong, Hong-Huant; Hou, Cheng-Bo

    2014-12-01

    The evaluation of permeability in biopharmaceutics classification system of Chinese materia medica (CMMBCS) requires multicomponent as a whole in order to conduct research, even in the study of a specific component, should also be put in the multicomponent environment. Based on this principle, the high content components in Gegen Qinlian decoction were used as multicomponent environmental impact factors in the experiment, and the relevant parameters of intestinal permeability about puerarin were measured with using in situ single-pass intestinal perfusion model, to investigate and evaluate the intestinal permeability of puerarin with other high content components. The experimental results showed that different proportions of baicalin, glycyrrhizic acid and berberine had certain influence on intestinal permeability of puerarin, and glycyrrhizic acid could significantly inhibit the intestinal absorption of puerarin, moreover, high concentration of berberine could promote the absorption of puerarin. The research results indicated that the important research ideas of permeability evaluation in biopharmaceutics classification system of Chinese materia medica with fully considering the effects of other ingredients in multicomponent environment.

  8. The biopharmaceutics of successful controlled release drug product: Segmental-dependent permeability of glipizide vs. metoprolol throughout the intestinal tract.

    Science.gov (United States)

    Zur, Moran; Cohen, Noa; Agbaria, Riad; Dahan, Arik

    2015-07-15

    The purpose of this work was to study the challenges and prospects of regional-dependent absorption in a controlled-release scenario, through the oral biopharmaceutics of the sulfonylurea antidiabetic drug glipizide. The BCS solubility class of glipizide was determined, and its physicochemical properties and intestinal permeability were thoroughly investigated, both in-vitro (PAMPA and Caco-2) and in-vivo in rats. Metoprolol was used as the low/high permeability class boundary marker. Glipizide was found to be a low-solubility compound. All intestinal permeability experimental methods revealed similar trend; a mirror image small intestinal permeability with opposite regional/pH-dependency was obtained, a downward trend for glipizide, and an upward trend for metoprolol. Yet the lowest permeability of glipizide (terminal Ileum) was comparable to the lowest permeability of metoprolol (proximal jejunum). At the colon, similar permeability was evident for glipizide and metoprolol, that was higher than metoprolol's jejunal permeability. We present an analysis that identifies metoprolol's jejunal permeability as the low/high permeability class benchmark anywhere throughout the intestinal tract; we show that the permeability of both glipizide and metoprolol matches/exceeds this threshold throughout the entire intestinal tract, accounting for their success as controlled-release dosage form. This represents a key biopharmaceutical characteristic for a successful controlled-release dosage form. Copyright © 2015 Elsevier B.V. All rights reserved.

  9. Specialty-service lines: salvos in the new medical arms race.

    Science.gov (United States)

    Berenson, Robert A; Bodenheimer, Thomas; Pham, Hoangmai H

    2006-01-01

    Hospitals and physicians are developing and marketing discrete and profitable specialty-service lines. Although closely affiliated specialist physicians are central to hospitals' service-line products, other physicians compete directly with hospitals via physician-owned specialty facilities. Specialty-service lines may be provided in a variety of settings, both inside and outside traditional hospital walls. Thus far, the escalating battle between hospitals and physicians for control over specialty services has not affected hospital profitability. However, as the scope of care that can be safely performed in the outpatient arena expands, physician competition for control over specialty services may threaten hospitals' financial health.

  10. Knowledge silos: assessing knowledge sharing between specialties through the vestibular schwannoma literature.

    Science.gov (United States)

    Schnurman, Zane; Golfinos, John G; Roland, J Thomas; Kondziolka, Douglas

    2017-12-01

    OBJECTIVE It is common for a medical disorder to be managed or researched by individuals who work within different specialties. It is known that both neurosurgeons and neurotologists manage vestibular schwannoma (VS) patients. While overlap in specialty focus has the potential to stimulate multidisciplinary collaboration and innovative thinking, there is a risk of specialties forming closed-communication loops, called knowledge silos, which may inhibit knowledge diffusion. This study quantitatively assessed knowledge sharing between neurosurgery and otolaryngology on the subject of VS. METHODS A broad Web of Science search was used to download details for 4439 articles related to VS through 2016. The publishing journal's specialty and the authors' specialties (based on author department) were determined for available articles. All 114,647 of the article references were categorized by journal specialty. The prevalence of several VS topics was assessed using keyword searches of titles. RESULTS For articles written by neurosurgeons, 44.0% of citations were from neurosurgery journal articles and 23.4% were from otolaryngology journals. The citations of otolaryngology authors included 11.6% neurosurgery journals and 56.5% otolaryngology journals. Both author specialty and journal specialty led to more citations of the same specialty, though author specialty had the largest effect. Comparing the specialties' literature, several VS topics had significantly different levels of coverage, including radiosurgery and hearing topics. Despite the availability of the Internet, there has been no change in the proportions of references for either specialty since 1997 (the year PubMed became publicly available). CONCLUSIONS Partial knowledge silos are observed between neurosurgery and otolaryngology on the topic of VS, based on the peer-reviewed literature. The increase in access provided by the Internet and searchable online databases has not decreased specialty reference bias

  11. Using marketing research concepts to investigate specialty selection by medical students.

    Science.gov (United States)

    Weissman, Charles; Schroeder, Josh; Elchalal, Uriel; Weiss, Yoram; Tandeter, Howard; Zisk-Rony, Rachel Y

    2012-10-01

    This study was intended to examine whether a marketing research approach improves understanding of medical specialty selection by medical students. This approach likens students to consumers who are deciding whether or not to purchase a product (specialty). This approach proposes that when consumers' criteria match their perceptions of a product's features, the likelihood that they will purchase it (select the specialty) increases. This study examines whether exploring students' selection criteria and perceptions of various specialties provides additional insights into the selection process. Using a consumer behaviour model as a framework, a questionnaire was designed and administered to Year 6 (final-year) students in 2008 and 2009 to elicit information on their knowledge about and interests in various specialties, the criteria they used in specialty selection, and their perceptions of six specialties. A total of 132 (67%) questionnaires were returned. In many instances, consistency between selection criteria and perceptions of a specialty was accompanied by interest in pursuing the specialty. Exceptions were noted and pointed to areas requiring additional research. For example, although > 70% of female students replied that the affordance of a controllable lifestyle was an important selection criterion, many were interested in obstetrics and gynaecology despite the fact that it was not perceived as providing a controllable lifestyle. Minimal overlap among students reporting interest in primary specialties that possess similar characteristics (e.g. paediatrics and family medicine) demonstrated the need to target marketing (recruitment) efforts for each specialty individually. Using marketing research concepts to examine medical specialty selection may precipitate a conceptual shift among health care leaders which acknowledges that, to attract students, specialties must meet students' selection criteria. Moreover, if consumers (students) deem a product (specialty

  12. Specialty-specific admission: a cost-effective intervention?

    LENUS (Irish Health Repository)

    Slattery, E

    2012-02-01

    INTRODUCTION: Cost effectiveness of healthcare has become an important component in its delivery. Current practices need to be assessed and measured for variations that may lead to financial savings. Speciality specific admission is known not only to lead improved clinical outcomes but also to lead important cost reductions. METHODS: All patients admitted to an Irish teaching hospital via the emergency department over a 2-year period with a gastroenterology (GI) related illness were included in this analysis.GI illness was classified using the Disease related grouping (DRG) system. Mean length of stay (LOS) and patient level costing (PLC) were calculated. Differences between DRGs with respect to speciality (i.e. specialist vs. non-specialist) were calculated for the five commonest DRGs. RESULTS: Significant variations in LOS and PLC were demonstrated in the DRGs. Mean LOS varied with increasing complexity, from 3.2 days for non-complex GI haemorrhage to 14.4 days for complex alcohol related cirrhosis as expected. A substantial difference in LOS within DRG groups was demonstrated by large standard deviations in the mean (up to 8.1 days in some groups) and was independent of complexity of cases. PLC also varied widely in both complex and non-complex cases with standard deviations of up to 17,342 noted. Specialty-specific admission was associated with shorter LOS for most GI admissions. CONCLUSION: Significant disparity exists for both LOS and PLC for most GI diagnoses. Specialty-specific admissions are associated with reduced LOS. Specialty-specific admission would appear to be cost-effective which may also lead to improved clinical outcomes.

  13. Access to specialty mental health services among women in California.

    Science.gov (United States)

    Kimerling, Rachel; Baumrind, Nikki

    2005-06-01

    The Anderson behavioral model was used to investigate racial and ethnic disparities in access to specialty mental health services among women in California as well as factors that might account for such disparities. The study was a cross-sectional examination of a probability sample of 3,750 California women. The main indicators of access to services were perceived need, service seeking, and service use. Multivariate models were constructed that accounted for need and enabling and demographic variables. Significant racial and ethnic variations in access to specialty mental health services were observed. African-American, Hispanic, and Asian women were significantly less likely to use specialty mental health services than white women. Multivariate analyses showed that Hispanic and Asian women were less likely than white women to report perceived need, even after frequent mental distress had been taken into account. Among women with perceived need, African-American and Asian women were less likely than white women to seek mental health services after differences in insurance status had been taken into account. Among women who sought services, Hispanic women were less likely than white women to obtain services after adjustment for the effects of poverty. Need and enabling factors did not entirely account for the observed disparities in access to services. Additional research is needed to identify gender- and culture-specific models for access to mental health services in order to decrease disparities in access. Factors such as perceived need and decisions to seek services are important factors that should be emphasized in future studies.

  14. Surgical resident perceptions of trauma surgery as a specialty.

    Science.gov (United States)

    Hadzikadic, Lejla; Burke, Peter A; Esposito, Thomas J; Agarwal, Suresh

    2010-05-01

    Presenting the opinions of surgical residents about the appeal of trauma surgery as a specialty may influence current reform. Survey study. Academic research. General surgery residents (postgraduate years 1-5 and recent graduates) registered with the American College of Surgeons. A 22-item survey. Career plans and perceptions about trauma surgery as a specialty. Of 6006 mailed surveys, we had a 20.1% response rate. Midlevel residents comprised most of the respondents, and most were undecided about their career choice or planned to enter general surgical private practice. The typical residency programs represented were academic (81.7%), urban (90.6%), and level I trauma centers (78.7%), and included more than 6 months of trauma experience (77.6%). Most respondents (70.6%) thought that trauma surgery was unappealing. The most important deterrents to entering the field were lifestyle, poor reimbursement, and limited operating room exposure, while increased surgical critical care was not seen as a restriction. When questioned about the future of trauma surgery, they believed that trauma surgeons should perform elective (86.8%) and nontrauma emergency (91.5%) cases and would benefit from active association with an outpatient clinic (76.0%). Intellectual challenge and exciting nature of the field were listed as the most appealing aspects, and ideal practice characteristics included guaranteed salary and time away from work. As demand for trauma surgeons increases, resident interest has dwindled. As a specialty, trauma surgery must undergo changes that reflect the needs of the incoming generation. We present a sampling of current surgical resident opinion and offer these data to assist the changing discipline and the evolving field of acute care surgery.

  15. Strategies for Introducing Outpatient Specialty Palliative Care in Gynecologic Oncology.

    Science.gov (United States)

    Hay, Casey M; Lefkowits, Carolyn; Crowley-Matoka, Megan; Bakitas, Marie A; Clark, Leslie H; Duska, Linda R; Urban, Renata R; Creasy, Stephanie L; Schenker, Yael

    2017-09-01

    Concern that patients will react negatively to the idea of palliative care is cited as a barrier to timely referral. Strategies to successfully introduce specialty palliative care to patients have not been well described. We sought to understand how gynecologic oncologists introduce outpatient specialty palliative care. We conducted a national qualitative interview study at six geographically diverse academic cancer centers with well-established palliative care clinics between September 2015 and March 2016. Thirty-four gynecologic oncologists participated in semistructured telephone interviews focusing on attitudes, experiences, and practices related to outpatient palliative care. A multidisciplinary team analyzed interview transcripts using constant comparative methods to inductively develop and refine a coding framework. This analysis focuses on practices for introducing palliative care. Mean participant age was 47 years (standard deviation, 10 years). Mean interview length was 25 minutes (standard deviation, 7 minutes). Gynecologic oncologists described the following three main strategies for introducing outpatient specialty palliative care: focus initial palliative care referral on symptom management to dissociate palliative care from end-of-life care and facilitate early relationship building with palliative care clinicians; use a strong physician-patient relationship and patient trust to increase acceptance of referral; and explain and normalize palliative care referral to address negative associations and decrease patient fear of abandonment. These strategies aim to decrease negative patient associations and encourage acceptance of early referral to palliative care specialists. Gynecologic oncologists have developed strategies for introducing palliative care services to alleviate patient concerns. These strategies provide groundwork for developing system-wide best practice approaches to the presentation of palliative care referral.

  16. Resident and program director gender distribution by specialty.

    Science.gov (United States)

    Long, Timothy R; Elliott, Beth A; Warner, Mary Ellen; Brown, Michael J; Rose, Steven H

    2011-12-01

    Although enrollment of women in U.S. medical schools has increased, women remain less likely to achieve senior academic rank, lead academic departments, or be appointed to national leadership positions. The purpose of this paper is to compare the gender distribution of residency program directors (PDs) with residents and faculty in the 10 largest specialties. The gender distribution of residents training in the 10 specialties with the largest enrollment was obtained from the annual education issue of Journal of the American Medical Association. The gender distribution of the residents was compared with the gender distribution of PDs and medical school faculty. The number of programs and the names of the PDs were identified by accessing the Accreditation Council for Graduate Medical Education web site. Gender was confirmed through electronic search of state medical board data, program web sites, or by using internet search engines. The gender distribution of medical school faculty was determined using the Association of American Medical Colleges faculty roster database (accessed June 15, 2011). The correlation between female residents and PDs was assessed using Pearson's product-moment correlation. The gender distribution of female PDs appointed June 1, 2006, through June 1, 2010, was compared with the distribution appointed before June 1, 2006, using chi square analysis. Specialties with higher percentages of female PDs had a higher percentage of female residents enrolled (r=0.81, p=0.005). The number of female PDs appointed from July 1, 2006, through June 30, 2010, was greater than the number appointed before July 1, 2006, in emergency medicine (pWomen remain underrepresented in PD appointments relative to the proportion of female medical school faculty and female residents. Mechanisms to address gender-based barriers to advancement should be considered.

  17. Residents' views about family medicine specialty education in Turkey

    Directory of Open Access Journals (Sweden)

    Uzuner Arzu

    2010-04-01

    Full Text Available Abstract Background Residents are one of the key stakeholders of specialty training. The Turkish Board of Family Medicine wanted to pursue a realistic and structured approach in the design of the specialty training programme. This approach required the development of a needs-based core curriculum built on evidence obtained from residents about their needs for specialty training and their needs in the current infrastructure. The aim of this study was to obtain evidence on residents' opinions and views about Family Medicine specialty training. Methods This is a descriptive, cross-sectional study. The board prepared a questionnaire to investigate residents' views about some aspects of the education programme such as duration and content, to assess the residents' learning needs as well as their need for a training infrastructure. The questionnaire was distributed to the Family Medicine Departments (n = 27 and to the coordinators of Family Medicine residency programmes in state hospitals (n = 11 by e-mail and by personal contact. Results A total of 191 questionnaires were returned. The female/male ratio was 58.6%/41.4%. Nine state hospitals and 10 university departments participated in the study. The response rate was 29%. Forty-five percent of the participants proposed over three years for the residency duration with either extensions of the standard rotation periods in pediatrics and internal medicine or reductions in general surgery. Residents expressed the need for extra rotations (dermatology 61.8%; otolaryngology 58.6%; radiology 52.4%. Fifty-nine percent of the residents deemed a rotation in a private primary care centre necessary, 62.8% in a state primary care centre with a proposed median duration of three months. Forty-seven percent of the participants advocated subspecialties for Family Medicine, especially geriatrics. The residents were open to new educational methods such as debates, training with models, workshops and e

  18. Summary of the NICHD-BPCA Pediatric Formulation Initiatives Workshop-Pediatric Biopharmaceutics Classification System (PBCS) Working Group

    Science.gov (United States)

    Abdel-Rahman, Susan; Amidon, Gordon L.; Kaul, Ajay; Lukacova, Viera; Vinks, Alexander A.; Knipp, Gregory

    2012-01-01

    The Biopharmaceutics Classification System (BCS) allows compounds to be classified based on their in vitro solubility and intestinal permeability. The BCS has found widespread use in the pharmaceutical community as an enabling guide for the rational selection of compounds, formulation for clinical advancement and generic biowaivers. The Pediatric Biopharmaceutics Classification System (PBCS) working group was convened to consider the possibility of developing an analogous pediatric based classification system. Since there are distinct developmental differences that can alter intestinal contents, volumes, permeability and potentially biorelevant solubilities at the different ages, the PBCS working group focused on identifying age specific issues that would need to be considered in establishing a flexible, yet rigorous PBCS. Objective To summarize the findings of the PBCS working group and provide insights into considerations required for the development of a pediatric based biopharmaceutics classification system. Methods Through several meetings conducted both at The Eunice Kennedy Shriver National Institute of Child Health, Human Development (NICHD)-US Pediatric Formulation Initiative (PFI) workshop (November 2011) and via teleconferences, the PBCS working group considered several high level questions that were raised to frame the classification system. In addition, the PBCS working group identified a number of knowledge gaps that would need to be addressed in order to develop a rigorous PBCS. Results It was determined that for a PBCS to be truly meaningful, it would need to be broken down into several different age groups that would account for developmental changes in intestinal permeability, luminal contents, and gastrointestinal transit. Several critical knowledge gaps where identified including: 1) a lack of fully understanding the ontogeny of drug metabolizing enzymes and transporters along the gastrointestinal (GI) tract, in the liver and in the kidney; 2

  19. Prevalence of dry eye syndrome in residents of surgical specialties.

    Science.gov (United States)

    Castellanos-González, José Alberto; Torres-Martínez, Verónica; Martínez-Ruiz, Adriana; Fuentes-Orozco, Clotilde; Rendón-Félix, Jorge; Irusteta-Jiménez, Leire; Márquez-Valdez, Aída Rebeca; Cortés-Lares, José Antonio; González-Ojeda, Alejandro

    2016-07-16

    The aim of this study was to determine the prevalence and severity of dry eye syndrome in a group of Mexican residents of different surgical specialties. A cross-sectional descriptive study where the residents were studied using the Ocular Surface Disease Index, together with diagnostic tests for dry eye syndrome, such as tear breakup time, Oxford Schema, Schirmer's test I, and meibomian gland dysfunction testing. Statistical analyses were performed by Pearson's chi-squared test for categorical variables and student's t-test for quantitative variables. Any P value eyes); 90 (73 %) were male and 33 (27 %) were female. The mean age was 27.8 ± 2.1 years. A higher number of residents with dry eye syndrome was found in the cardiothoracic surgery (75 %) and otorhinolaryngology (71 %) specialties; 70 % of them reported ocular symptoms, with teardrop quality involvement in >50 % of them. We found a prevalence of 56 % for mild-to-moderate/severe stages of the condition. Their presence in the operating room predisposes surgical residents to dry eye syndrome because of environmental conditions.

  20. Oral health in Brazil - Part II: Dental Specialty Centers (CEOs

    Directory of Open Access Journals (Sweden)

    Vinícius Pedrazzi

    2008-08-01

    Full Text Available The concepts of health promotion, self-care and community participation emerged during the 1970s and, since then, their application has grown rapidly in the developed world, showing evidence of effectiveness. In spite of this, a major part of the population in the developing countries still has no access to specialized dental care such as endodontic treatment, dental care for patients with special needs, minor oral surgery, periodontal treatment and oral diagnosis. This review focuses on a program of the Brazilian Federal Government named CEOs (Dental Specialty Centers, which is an attempt to solve the dental care deficit of a population that is suffering from oral diseases and whose oral health care needs have not been addressed by the regular programs offered by the SUS (Unified National Health System. Literature published from 2000 to the present day, using electronic searches by Medline, Scielo, Google and hand-searching was considered. The descriptors used were Brazil, Oral health, Health policy, Health programs, and Dental Specialty Centers. There are currently 640 CEOs in Brazil, distributed in 545 municipal districts, carrying out dental procedures with major complexity. Based on this data, it was possible to conclude that public actions on oral health must involve both preventive and curative procedures aiming to minimize the oral health distortions still prevailing in developing countries like Brazil.

  1. The demand for ambulatory mental health services from specialty providers.

    Science.gov (United States)

    Horgan, C M

    1986-01-01

    A two-part model is used to examine the demand for ambulatory mental health services in the specialty sector. In the first equation, the probability of having a mental health visit is estimated. In the second part of the model, variations in levels of use expressed in terms of visits and expenditures are examined in turn, with each of these equations conditional on positive utilization of mental health services. In the second part of the model, users are additionally grouped into those with and without out-of-pocket payment for services. This specification accounts for special characteristics regarding the utilization of ambulatory mental health services: (1) a large part of the population does not use these services; (2) of those who use services, the distribution of use is highly skewed; and (3) a large number of users have zero out-of-pocket expenditures. Cost-sharing does indeed matter in the demand for ambulatory mental health services from specialty providers; however, the decision to use mental health services is affected by the level of cost-sharing to a lesser degree than is the decision regarding the level of use of services. The results also show that price is only one of several important factors in determining the demand for services. The lack of significance of family income and of being female is notable. Evidence is presented for the existence of bandwagon effects. The importance of Medicaid in the probability of use equations is noted. PMID:3721874

  2. High prevalence of sexual dysfunction in a vulvovaginal specialty clinic

    Science.gov (United States)

    Gordon, Dina; Gardella, Carolyn; Eschenbach, David; Mitchell, Caroline M.

    2014-01-01

    Objective Our study evaluated the presence and predictors of sexual dysfunction in a vulvovaginal specialty clinic population. Materials & Methods Women who presented to a vulvovaginal specialty clinic were eligible to enroll. Participants completed a questionnaire, including Female Sexual Function Index (FSFI) to assess sexual dysfunction and Patient Health Questionnaire (PHQ)-9 depression screen, and underwent a standardized physical exam, with vaginal swabs collected for wet mount and culture. Logistic regression assessed the relationship between sexual dysfunction and clinical diagnosis. Results We enrolled 161 women, aged 18–80 years (median = 36), presenting with vulvovaginal complaints. Median symptom duration was 24 months; 131 women (81%) reported chronic symptoms (≥12 months). By PHQ-9, 28 (17%) women met depression criteria. In the month prior to assessment, 86 (53%) women experienced sexual dysfunction. Women were primarily diagnosed with vaginitis (n = 46, 29%), vestibulodynia/vulvitis (n = 70; 43%), lichen planus or lichen sclerosus (n = 24; 15%). Controlling for age, sexual dysfunction did not correlate with chronic symptoms (IRR 0.86, 95% CI 0.50–1.48), depression (IRR 1.24; 95% CI 0.59, 2.58), or presence of any of the three main diagnoses (IRR 1.16, 95% CI 0.47, 2.88). Discussion Sexual dysfunction is present in over half of women presenting to a vulvovaginitis referral clinic, more than twice the rate in the wider population. PMID:25259664

  3. Physician attitudes toward industry: a view across the specialties

    Science.gov (United States)

    Korenstein, Deborah; Keyhani, Salomeh; Ross, Joseph S.

    2010-01-01

    Objectives Physician relationships with industry are receiving attention as government and professional organizations move toward restrictive policies and financial transparency. Our objective was to explore attitudes of physicians from all specialties toward gifts from and interactions with the pharmaceutical and device industries. Design Anonymous cross sectional survey. Setting Hospitals in the Mount Sinai School of Medicine consortium, in the New York City metro area Participants Faculty and trainee physicians from all clinical departments Main Outcome Measures Attitudes toward industry interactions and gifts and their appropriateness, measured on 4-point Likert scales. Results Five hundred ninety physicians and medical students completed the survey (response rate=67%); 59% were male, 39% were attendings, and 24% were from surgical specialties. Attitudes toward industry and gifts were generally positive. More than 65% found educational materials and sponsored lunches appropriate, whereas fewer than 25% considered vacations or large gifts appropriate. Surgeons, trainees, and those unfamiliar with institutional policies on industry interactions held more positive attitudes than others and were more likely to deem some gifts appropriate, including industry funding of residency programs and, among surgeons, receiving meals, travel expenses, and payments for attending lectures. Non-attendings held more positive attitudes toward meals in clinical settings, textbooks and samples. Conclusions Physicians continue to hold positive attitudes toward marketing-oriented activities of the pharmaceutical and device industries. Changes in medical culture and physician education focused on surgeons and trainees may align physician attitudes with current policy trends. PMID:20566978

  4. Application of transglycosylated stevia and hesperidin as drug carriers to enhance biopharmaceutical properties of poorly-soluble artemisinin.

    Science.gov (United States)

    Letchmanan, Kumaran; Shen, Shou-Cang; Ng, Wai Kiong; Tan, Reginald B H

    2018-01-01

    Biopharmaceutical properties of poorly water-soluble antimalarial drug, Artemisinin (ART), were improved by formulating amorphous solid dispersions with transglycosylated food additives (Hsp-G and Stevia-G) via co-spray drying. Both the formulated ART/Hsp-G and ART/Stevia-G showed superior dissolution properties with a burst release of more than 95% of drug within 5 min, whereas untreated ART dissolved only 4% in 5min. The supersaturation solubility of the formulated ART was enhanced by 2-fold as compared with untreated counterpart. The storage stability tests indicated that these formulations chemically stable at room temperature and under low humidity (water-soluble ART. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Prediction of bioavailability of selected bisphosphonates using in silico methods towards categorization into a biopharmaceutical classification system.

    Science.gov (United States)

    Biernacka, Joanna; Betlejewska-Kielak, Katarzyna; Kłosińska-Szmurło, Ewa; Pluciński, Franciszek A; Mazurek, Aleksander P

    2013-01-01

    The physicochemical properties relevant to biological activity of selected bisphosphonates such as clodronate disodium salt, etidronate disodium salt, pamidronate disodium salt, alendronate sodium salt, ibandronate sodium salt, risedronate sodium salt and zoledronate disodium salt were determined using in silico methods. The main aim of our research was to investigate and propose molecular determinants thataffect bioavailability of above mentioned compounds. These determinants are: stabilization energy (deltaE), free energy of solvation (deltaG(solv)), electrostatic potential, dipole moment, as well as partition and distribution coefficients estimated by the log P and log D values. Presented values indicate that selected bisphosphonates a recharacterized by high solubility and low permeability. The calculated parameters describing both solubility and permeability through biological membranes seem to be a good bioavailability indicators of bisphosphonates examined and can be a useful tool to include into Biopharmaceutical Classification System (BCS) development.

  6. FEATURES OF THE HIGHEST QUALIFICATION IN THE SPECIALTY «INFORMATION AND COMMUNICATION TECHNOLOGIES IN EDUCATION»

    OpenAIRE

    O.M. Spirin; A.V. Iatsyshyn

    2013-01-01

    The paper analyzes the prerequisites for developing and becoming of new specialty 13.00.10 – information and communication technology in education. The features of training of the high-qualified specialists at the Institute of information technologies and learning tools of NAPS of Ukraine are examined. The subjects of dissertations on new specialty, are studied the respective research directions in new specialty are defined. The features of the formulation of scientific and categorical appara...

  7. A survey of sub-specialty preferences of radiography students of the University of Lagos, Nigeria

    Directory of Open Access Journals (Sweden)

    E T Namah

    2013-01-01

    Full Text Available Background: Technological advances and computing have expanded both the scope and capacity of diagnostic medical imaging (the radiography profession. This has created many diverse imaging modalities which in turn, have culminated in different sub-specialties in the profession. Objective: The aims of the study were to determine the level of awareness of imaging sub-specialties, preferred sub specialties and reasons for preferences of sub-specialties in senior level radiography students of the University of Lagos. Methods: The study was a prospective cross-sectional survey. Consents were obtained before the students were recruited for the study. Data Collection and Analysis: A questionnaire semi-structured in line with objectives of the study was used in data collection. A computer software Epi Info version 3.3 was used to analyze data while results were expressed as percentages of responses and were presented in tables and pie charts. Results : Greater than 90% showed awareness of sub-specialties in the radiography profession whereas 35% preferred ultrasonography to other sub-specialties. The least preferred sub-specialty was conventional radiography (4.3%. Remuneration (73.3% and less physical exertion (73.3% were major attractors to preferred sub-specialties whereas concerns over radiation hazard were major detractors (58.3%. Conclusion : Awareness of sub-specialties in the radiography profession was high amongst students studied. Furthermore, ultrasonography was the most preferred sub-specialty among the respondents. Remuneration was the main attractor to sub-specialties whereas fears over effects of ionizing radiation were the major detractors to some sub-specialties.

  8. Abstracts of the Canadian Society for Civil Engineering annual conference including the general conference, the 1. international structural specialty conference, the 1. international construction specialty conference, and the 1. specialty conference on disaster mitigation : towards a sustainable future

    International Nuclear Information System (INIS)

    El-Badry, M.; Loov, R.E.; Ruwanpura, J.; El-Hacha, R.; Kroman, J.; Rankin, J.

    2006-01-01

    This conference provided a forum for national and international practicing engineers, researchers and technical experts to discuss sustainable solutions to infrastructure development. Discussions focused on recent developments in new technologies for building more economic and sustainable infrastructure, while improving the safety of buildings, bridges, roads, water supply and sewage treatment systems. The conference was held in conjunction with associated specialty conferences, including a first international structures specialty conference, a first international construction specialty conference, and a first specialty conference on disaster mitigation. This book of abstracts highlights all the specialty conferences and accompanies a CD-ROM that has the full text of all the papers. Manuscripts of the full papers submitted to the specialty conferences were peer-reviewed by international scientific committees. The general conference provided a forum to learn about new technologies and future directions in various areas of civil engineering. It included a special theme session on sustainable development and a special session on innovation and information technology. Other technical sessions focused on topics such as civil engineering history and education; infrastructure management and renewal; asset management; risk assessment and management; engineering materials and mechanics; environmental engineering and science; hydrotechnical engineering; cold region engineering; and, transportation engineering. The general conference featured 88 presentations, of which 15 have been catalogued separately for inclusion in this database

  9. 40 CFR 407.80 - Applicability; description of the canned and miscellaneous specialties subcategory.

    Science.gov (United States)

    2010-07-01

    ... ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CANNED AND PRESERVED FRUITS AND VEGETABLES PROCESSING POINT SOURCE CATEGORY Canned and Miscellaneous Specialties Subcategory § 407.80...

  10. The research on teaching reformation of photoelectric information science and engineering specialty experiments

    Science.gov (United States)

    Zhu, Zheng; Yang, Fan; Zhang, Yang; Geng, Tao; Li, Yuxiang

    2017-08-01

    This paper introduced the idea of teaching reformation of photoelectric information science and engineering specialty experiments. The teaching reformation of specialty experiments was analyzed from many aspects, such as construction of specialized laboratory, experimental methods, experiment content, experiment assessing mechanism, and so on. The teaching of specialty experiments was composed of four levels experiments: basic experiments, comprehensive and designing experiments, innovative research experiments and engineering experiments which are aiming at enterprise production. Scientific research achievements and advanced technology on photoelectric technology were brought into the teaching of specialty experiments, which will develop the students' scientific research ability and make them to be the talent suitable for photoelectric industry.

  11. Doctors who considered but did not pursue specific clinical specialties as careers: questionnaire surveys.

    Science.gov (United States)

    Goldacre, Michael J; Goldacre, Raph; Lambert, Trevor W

    2012-04-01

    To report doctors' rejection of specialties as long-term careers and reasons for rejection. Postal questionnaires. United Kingdom. Graduates of 2002, 2005 and 2008 from all UK medical schools, surveyed one year after qualification. Current specialty choice; any choice that had been seriously considered but not pursued (termed 'rejected' choices) with reasons for rejection. 2573 of 9155 respondents (28%) had seriously considered but then not pursued a specialty choice. By comparison with positive choices, general practice was under-represented among rejected choices: it was the actual choice of 27% of respondents and the rejected choice of only 6% of those who had rejected a specialty. Consideration of 'job content' was important in not pursuing general practice (cited by 78% of those who considered but rejected a career in general practice), psychiatry (72%), radiology (69%) and pathology (68%). The surgical specialties were the current choice of 20% of respondents and had been considered but rejected by 32% of doctors who rejected a specialty. Issues of work-life balance were the single most common factor, particularly for women, in not pursuing the surgical specialties, emergency medicine, the medical hospital specialties, paediatrics, and obstetrics and gynaecology. Competition for posts, difficult examinations, stressful working conditions, and poor training were mentioned but were mainly minority concerns. There is considerable diversity between doctors in their reasons for finding specialties attractive or unattractive. This underlines the importance of recruitment strategies to medical school that recognize diversity of students' interests and aptitudes.

  12. Design and Implementation of the Automatic Assessment System for the Command and Control Specialty in Ships

    Directory of Open Access Journals (Sweden)

    Zhang Hao

    2017-01-01

    Full Text Available On the basis of analyzing the actual demand of automated assessment system for the command and control specialty in ships, the thought of the overall design of automated assessment system for the command and control specialty in ships is given, and the concrete realization methods of the user login module, test paper operation module and system maintenance module are studied and demonstrated. The proposed design idea and implementation method of automated assessment system for the command and control specialty in ships is scientific, efficient and practical, and provides reference for the exploitation of automated assessment system for the command and control specialty in ships.

  13. The taste transformation ritual in the specialty coffee market

    Directory of Open Access Journals (Sweden)

    Ronan Torres Quintão

    2017-10-01

    Full Text Available Although the consumer culture field has addressed the role of ritual processes in consumption, no research has yet identified how connoisseur consumers, through ritual practices, establish and manipulate their distinction from other consumers. Drawing on key concepts from ritual theory, this research addresses the role played by ritual in connoisseurship consumption and consumers’ taste. In conducting an ethnographic study on connoisseurship consumption, the first author immersed himself in the North American specialty coffee context—Toronto, Montreal, Seattle, and New York—from August 2013 to July 2014. He used long interviews and participant observation to collect data, which was then interpreted using a hermeneutic approach. We introduce the taste transformation ritual, theorizing the process that converts regular consumers into connoisseur consumers by establishing and reinforcing differences between mass and connoisseurship consumption. We develop a broader theoretical account that builds on consumption ritual and taste formation.

  14. Amaurosis fugax – delay between symptoms and surgery by specialty

    Directory of Open Access Journals (Sweden)

    Kvickström P

    2016-11-01

    Full Text Available Pia Kvickström,1 Bertil Lindblom,2,3 Göran Bergström,4,5 Madeleine Zetterberg2,3 1Department of Ophthalmology, Skaraborg Hospital, Skövde, 2Department of Clinical Neuroscience/Ophthalmology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, 3Department of Ophthalmology, Sahlgrenska University Hospital, Mölndal, 4Department of Molecular and Clinical Medicine, The Sahlgrenska Academy at University of Gothenburg, 5Department of Clinical Physiology, Sahlgrenska University Hospital, Gothenburg, Sweden Purpose: To describe the time course of management of patients with amaurosis fugax and analyze differences in management by different specialties.Methods: Patients diagnosed with amaurosis fugax and subjected to carotid ultrasound in 2004–2010 at the Sahlgrenska University Hospital, Gothenburg, Sweden (n=302 were included in this retrospective cohort study, and data were collected from medical records.Results: The prevalence of significant carotid stenosis was 18.9%, and 14.2% were subjected to carotid endarterectomy. A trend of longer delay for surgery was noted for patients first consulting a general practitioner (P=0.069 as compared to hospital-based specialties. For 46.3% of the patients, an ophthalmologist was their first medical contact. No significant difference in time interval to endarterectomy was seen between ophthalmologists and neurologists/internists. Only 31.8% of the patients with significant carotid stenosis had carotid endarterectomy within 2 weeks from the debut of symptoms, and this proportion was smaller for patients residing outside the Gothenburg city area (P=0.038.Conclusion: Initially consulting an ophthalmologist does not delay the time to ultrasound or carotid endarterectomy. The overall time from symptoms to surgery is longer than recommended for a majority of the patients, especially for patients from rural areas and for patients initially consulting a general

  15. Consumer interest in specialty beers in three European markets.

    Science.gov (United States)

    Donadini, G; Fumi, M D; Kordialik-Bogacka, E; Maggi, L; Lambri, M; Sckokai, P

    2016-07-01

    This study explores the quality perception of specialty beers (SBs) in Italy, Spain and Poland. Five-hundred and fifty mainstream beer consumers were enrolled in this study (two-hundred and thirty Italians, one hundred and sixty Poles and Spaniards respectively). The authors adopted a conjoint rating experiment in which the respondents were given forty SB profiles to evaluate. Each profile was described on six attributes (malt type, adjuncts, alternative source of sugars, characterizing ingredients, sensory characteristics, and retail price) varied at different levels and were asked to state his/her preference for each profile on a 9-point scale of interest. The results of this study showed that the ideal SB: (1) for the aggregate Polish panel is brewed from malted wheat, raw wheat, honey, and tropical fruits, is alcoholic and is priced below 2.00 Euros; (2) for the aggregate Italian panel consists of a beer brewed from malted wheat, maize, honey, and vanilla, is blonde and costs a maximum of 2.00 Euros; (3) for the aggregate Spanish panel is brewed from malted wheat, rye or maize, vanilla, is fruity and is priced below 2.00 Euros. The heterogeneity of interest in specialty beers observed in the three countries under test requires for the adaptation of a SB specifically to each culture in which it is sold. In this process of customization, brewers must take into account that gender modulates the effect of culture on consumer interest in SB sensory characteristics and ingredient formulation. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. In-gap discounts in Medicare Part D and specialty drug use.

    Science.gov (United States)

    Jung, Jeah; Xu, Wendy Yi; Cheong, Chelim

    2017-09-01

    Specialty drugs can bring significant benefits to patients, but they can be expensive. Medicare Part D plans charge relatively high cost-sharing costs for specialty drugs. A provision in the Affordable Care Act reduced cost sharing in the Part D coverage gap phase in an attempt to mitigate the financial burden of beneficiaries with high drug spending. We examined the early impact of the Part D in-gap discount on specialty cancer drug use and patients' out-of-pocket (OOP) spending. Natural experimental design. We compared changes in outcomes before and after the in-gap discount among beneficiaries with and without low-income subsidies (LIS). Beneficiaries with LIS, who were not affected by the in-gap discount, made up the control group. We studied a random sample of elderly standalone prescription drug plan enrollees with relatively uncommon cancers (eg, leukemia, skin, pancreas, kidney, sarcomas, and non-Hodgkin lymphoma) between 2009 and 2013. We constructed 4 outcome variables annually: 1) use of any specialty cancer drug, 2) the number of specialty cancer drug fills, 3) total specialty drug spending, and 4) OOP spending for specialty cancer drugs. The in-gap discount did not influence specialty cancer drug use, but reduced annual OOP spending for specialty cancer drugs among users without LIS by $1108. In-gap discounts in Part D decreased patients' financial burden to some extent, but resulted in no change in specialty drug use. As demand for specialty drugs increases, it will be important to ensure patients' access to needed drugs, while simultaneously reducing their financial burden.

  17. Study on the Higher Vocational and Professional Specialty Ability Module of "Construction Management"

    Science.gov (United States)

    Gao, Qun

    2008-01-01

    The higher vocational and professional specialty of "construction management" of China begun late, and the talent training mode of various colleges are different, especially the analysis to the specialty ability modules on the higher vocational and professional layer is not mature. In this article, combining with the practice of Manjing…

  18. Formation of Professional Competence of Legal Specialty Students in the Elective Courses Studying

    Science.gov (United States)

    Akhmejanova, Gulnara; Olzhabayev, Bulat; Grigoryeva, Roza; Karibaeva, Zhanara; Avilkhan, Akmamyk; Sakenov, Janat

    2016-01-01

    This article examines the scientific problem of the formation of professional competence of legal specialty students in the elective courses studying. The analysis has been conducted and the content of professional competence of legal specialty students has been substantiated. This work substantiates the role of elective courses in the formation…

  19. The impact of endovascular repair on specialties performing abdominal aortic aneurysm repair

    NARCIS (Netherlands)

    K.H.J. Ultee (Klaas); R. Hurks (Rob); D.B. Buck (Dominique B.); G.S. Dasilva (George S.); P.A. Soden (Peter A.); J.A. van Herwaarden (Joost); H.J.M. Verhagen (Hence); M.L. Schermerhorn (Marc)

    2015-01-01

    textabstractBackground Abdominal aortic aneurysm (AAA) repair has been performed by various surgical specialties for many years. Endovascular aneurysm repair (EVAR) may be a disruptive technology, having an impact on which specialties care for patients with AAA. Therefore, we examined the proportion

  20. [Medical student perception of physician values in practice by individual characteristics and preferred medical specialty field].

    Science.gov (United States)

    Park, Kwi Hwa; Yoo, Hyo Hyun; Yim, Jun

    2014-12-01

    Medical students' values figure prominently in their choice of medical specialty; yet, little research has been performed on this topic. The purpose of this study was to analyze the differences in values according to medical students' individual characteristics (medical educational system, gender, and grade) and preferred medical specialty. A total of 905 medical students participated in the study; 426 were graduate-entry medical students (GEMS), and 479 were undergraduate medical students (UMS). Further, 561 were male and 316 were female; 356 were in year 1, 219 were in year 2, 230 were in year 3, and 100 were in year 4. Students completed the Physician Values in Practice Scale (PVIPS). The PVIPS comprises six dimensions: autonomy, management, prestige, service, lifestyle, and scholarly pursuits. The data were analyzed by t-test and analysis of variance. GEMS had higher scores for service, management, and scholarly pursuits than UMS. Males had higher scores for prestige, lifestyle, and management, whereas female scored higher on service and scholarly pursuits. Higher grade was associated with increased scores for prestige, lifestyle, and management. The differences in lifestyle and scholarly pursuits were significant between preferred specialties. Students in support specialties scored significantly higher on lifestyle. With regard to scholarly pursuits, basic science specialties scored significantly higher than other specialties. There were significant differences in PVIPS according to individual characteristics and preferred medical specialty. This result could be useful in developing a medical specialty choice program for medical students.

  1. 27 CFR 6.84 - Point of sale advertising materials and consumer advertising specialties.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Point of sale advertising materials and consumer advertising specialties. 6.84 Section 6.84 Alcohol, Tobacco Products and Firearms....84 Point of sale advertising materials and consumer advertising specialties. (a) General. The act by...

  2. 77 FR 40353 - Onyx Specialty Papers, Inc; Notice of Availability of Environmental Assessment

    Science.gov (United States)

    2012-07-09

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2985-008 Massachusetts] Onyx Specialty Papers, Inc; Notice of Availability of Environmental Assessment In accordance with the...), Commission staff has reviewed the Onyx Specialty Papers, Inc.'s application for surrender of project license...

  3. Embracing a competency-based specialty curriculum for community-based nursing roles.

    Science.gov (United States)

    Levin, Pamela F; Swider, Susan M; Breakwell, Susan; Cowell, Julia M; Reising, Virginia

    2013-01-01

    The Quad Council competencies for public health nursing (PHN) provide guidance in developing curricula at both the generalist and specialist level. However, these competencies are based on nursing roles in traditional public health agencies and community/public health is defined more broadly than official agency practice. The question arises as to whether community-based specialties require largely the same knowledge and skill set as PHN. The purpose of the competency cross-mapping project reported here was to (a) assess the intersection of the Quad Council competencies with four community-based specialties and (b) ensure the appropriateness of a Quad Council-based curriculum to prepare graduates across these four specialties (home health, occupational health, environmental health, and school nursing). This article details the multistep cross-mapping process, including validation with practice leaders. Results indicate strong alignment of community-based specialty competencies with Quad Council competencies. Community-based specialty-specific content that did not align well is identified, along with examples of didactic and clinical strategies to address gaps. This work indicates that a Quad Council-based curriculum is appropriate to prepare graduates in community-based specialties when attention to the specialty-specific competencies in the clinical setting is included. This work guides the development of a doctorate of nursing practice curriculum in PHN, encompassing the four additional community-based specialties. © 2013 Wiley Periodicals, Inc.

  4. The impact of endovascular repair on specialties performing abdominal aortic aneurysm repair

    NARCIS (Netherlands)

    Ultee, Klaas H J; Hurks, Rob; Buck, Dominique B.; Dasilva, George S.; Soden, Peter A.; Van Herwaarden, Joost A.; Verhagen, Hence J M; Schermerhorn, Marc L.

    2015-01-01

    Background Abdominal aortic aneurysm (AAA) repair has been performed by various surgical specialties for many years. Endovascular aneurysm repair (EVAR) may be a disruptive technology, having an impact on which specialties care for patients with AAA. Therefore, we examined the proportion of AAA

  5. Specialty pharmaceuticals care management in an integrated health care delivery system with electronic health records.

    Science.gov (United States)

    Monroe, C Douglas; Chin, Karen Y

    2013-05-01

    The specialty pharmaceuticals market is expanding more rapidly than the traditional pharmaceuticals market. Specialty pharmacy operations have evolved to deliver selected medications and associated clinical services. The growing role of specialty drugs requires new approaches to managing the use of these drugs. The focus, expectations, and emphasis in specialty drug management in an integrated health care delivery system such as Kaiser Permanente (KP) can vary as compared with more conventional health care systems. The KP Specialty Pharmacy (KP-SP) serves KP members across the United States. This descriptive account addresses the impetus for specialty drug management within KP, the use of tools such as an electronic health record (EHR) system and process management software, the KP-SP approach for specialty pharmacy services, and the emphasis on quality measurement of services provided. Kaiser Permanente's integrated system enables KP-SP pharmacists to coordinate the provision of specialty drugs while monitoring laboratory values, physician visits, and most other relevant elements of the patient's therapy. Process management software facilitates the counseling of patients, promotion of adherence, and interventions to resolve clinical, logistic, or pharmacy benefit issues. The integrated EHR affords KP-SP pharmacists advantages for care management that should become available to more health care systems with broadened adoption of EHRs. The KP-SP experience may help to establish models for clinical pharmacy services as health care systems and information systems become more integrated.

  6. Dental specialty, career preferences and their influencing factors among final year dental students in Saudi Arabia

    Directory of Open Access Journals (Sweden)

    Hassan Suliman Halawany

    2017-01-01

    Conclusion: The results of this study show the top preferred specialties and career choices which can be a baseline for establishing national policies and for the improvement of graduate programs. There seems to be a need to promote mentoring activities and provide guidance and encouragement to pre-doctoral dental students in selecting the most appropriate specialty within their capability domain.

  7. DETERMINANTS OF SPECIALTY CHOICE OF RESIDENT DOCTORS; CASE STUDY--AMONG RESIDENT DOCTORS IN NIGERIA.

    Science.gov (United States)

    Osuoji, Roland I; Adebanji, Atinuke; Abdulsalam, Moruf A; Oludara, Mobolaji A; Abolarinwa, Abimbola A

    2015-01-01

    This study examined medical specialty selection by Nigerian resident doctors using a marketing research approach to determine the selection criteria and the role of perceptions, expected remuneration, and job placement prospects of various specialties in the selection process. Data were from the Community of residents from April 2014 to July 2014. The cohort included 200 residents, but only 171 had complete information. Data were obtained from a cross section of resident doctors in the Lagos State University Teaching Hospital and at the 2014 Ordinary General Meeting of the National Association of Resident Doctors(NARD) where representatives from over 50 Teaching hospitals in Nigeria attended. Using a client behaviour model as a framework, a tripartite questionnaire was designed and administered to residents to deduce information on their knowledge about and interests in various specialties, their opinions of sixteen specialties, and the criteria they used in specialty selection. A total of 171 (85.5%) questionnaires were returned. ln many instances, consistency between selection criteria and perceptions of a specialty were accompanied by interest in pursuing the specialty. Job security, job availability on completion of programme, duration of training and qualifying examinations were highly correlated with p value marketing research concepts for medical specialty selection (Weissmanet al 2012) stipulates that choice of speciality is influenced by criteria and perception. This study shows that job security expected financial remuneration, and examination requirements for qualification are major determinants of the choice of speciality for residents.

  8. Do financial incentives linked to ownership of specialty hospitals affect physicians' practice patterns?

    Science.gov (United States)

    Mitchell, Jean M

    2008-07-01

    Although physician-owned specialty hospitals have become increasingly prevalent in recent years, little research has examined whether the financial incentives linked to ownership influence physicians' referral rates for services performed at the specialty hospital. We compared the practice patterns of physician owners of specialty hospitals in Oklahoma, before and after ownership, to the practice patterns of physician nonowners who treated similar cases over the same time period in Oklahoma markets without physician-owned specialty hospitals. We constructed episodes of care for injured workers with a primary diagnosis of back/spine disorders. We used pre-post comparisons and difference-in-differences analysis to evaluate changes in practice patterns for physician owners and nonowners over the time period spanned by the entry of the specialty hospital. Findings suggest the introduction of financial incentives linked to ownership coincided with a significant change in the practice patterns of physician owners, whereas such changes were not evident among physician nonowners. After physicians established ownership interests in a specialty hospital, the frequency of use of surgery, diagnostic, and ancillary services used in the treatment of injured workers with back/spine disorders increased significantly. Physician ownership of specialty hospitals altered the frequency of use for an array of procedures rendered to patients treated at these hospitals. Given the growth in physician-owned specialty hospitals, these findings suggest that health care expenditures will be substantially greater for patients treated at these institutions relative to persons who obtain care from nonself-referral providers.

  9. 75 FR 27536 - Notice of the Specialty Crop Committee's Stakeholder Listening Session

    Science.gov (United States)

    2010-05-17

    ... Stakeholder Listening Session AGENCY: Research, Education, and Economics, USDA. ACTION: Notice of stakeholder... United States Department of Agriculture announces a stakeholder listening session of the Specialty Crop... Advisory Board (NAREEE). DATES: The Specialty Crop Committee will hold the stakeholder listening session on...

  10. 75 FR 32735 - Notice of the Specialty Crop Committee's Stakeholder Listening Session

    Science.gov (United States)

    2010-06-09

    ... Stakeholder Listening Session AGENCY: Research, Education, and Economics, USDA. ACTION: Notice of stakeholder... United States Department of Agriculture announces a stakeholder listening session of the Specialty Crop... Advisory Board (NAREEE). DATES: The Specialty Crop Committee will hold the stakeholder listening session on...

  11. Marketing of specialty forest products in the southeast: opportunities for research, education and outreach (poster abstract)

    Science.gov (United States)

    A.L. Hammett; J.L. Chamberlain

    1999-01-01

    The specialty forest products sector in the Southeast is growing rapidly - perhaps faster than in other sections of the country. In 1993, the state of Virginia exported almost 10 percent of the national total of wild harvested ginseng. On a yearly basis, the value of the specialty forest products extracted from Virginia?s forests has been estimated at $35 million. The...

  12. Optimizing solubility and permeability of a biopharmaceutics classification system (BCS) class 4 antibiotic drug using lipophilic fragments disturbing the crystal lattice.

    Science.gov (United States)

    Tehler, Ulrika; Fagerberg, Jonas H; Svensson, Richard; Larhed, Mats; Artursson, Per; Bergström, Christel A S

    2013-03-28

    Esterification was used to simultaneously increase solubility and permeability of ciprofloxacin, a biopharmaceutics classification system (BCS) class 4 drug (low solubility/low permeability) with solid-state limited solubility. Molecular flexibility was increased to disturb the crystal lattice, lower the melting point, and thereby improve the solubility, whereas lipophilicity was increased to enhance the intestinal permeability. These structural changes resulted in BCS class 1 analogues (high solubility/high permeability) emphasizing that simple medicinal chemistry may improve both these properties.

  13. Evaluation of the Membrane Permeability (PAMPA and Skin) of Benzimidazoles with Potential Cannabinoid Activity and their Relation with the Biopharmaceutics Classification System (BCS)

    OpenAIRE

    Alvarez-Figueroa, M. Javiera; Pessoa-Mahana, C. David; Palavecino-González, M. Elisa; Mella-Raipán, Jaime; Espinosa-Bustos, Cristián; Lagos-Muñoz, Manuel E.

    2011-01-01

    The permeability of five benzimidazole derivates with potential cannabinoid activity was determined in two models of membranes, parallel artificial membrane permeability assay (PAMPA) and skin, in order to study the relationship of the physicochemical properties of the molecules and characteristics of the membranes with the permeability defined by the Biopharmaceutics Classification System. It was established that the PAMPA intestinal absorption method is a good predictor for classifying thes...

  14. Footprint and imprint: an ecologic time-trend analysis of cardiovascular publications in general and specialty journals.

    Science.gov (United States)

    Baldridge, Abigail S; Huffman, Mark D; Bloomfield, Gerald S; Prabhakaran, Dorairaj

    2014-06-01

    Studies have demonstrated strong associations between publication source and citations, as well as investigatory analysis of collaboration effects, in general and medical literature, but are limited to specific journals or short duration of time. This study sought to analyze time trends in cardiovascular research publications in leading general and specialty journals and to determine the association between collaboration and citation index. Cardiovascular publications were retrieved from Web of Knowledge by a cardiovascular bibliometric filter, and annual publication volumes in 8 general and specialty journals were compared. Univariable linear regression models were used to determine global and journal-specific trends for overall publication, cardiovascular publication, proportion of cardiovascular publication, collaboration, and citations. Cardiovascular publications increased (1999 to 2008) by 36% and number of sources by 74%. Volume increased in European Heart Journal (beta: 18.4, 95% confidence interval [CI]: 10.6 to 26.3) and decreased in Circulation (beta: -42.9, 95% CI: -79.3 to -6.5), Annals of Internal Medicine (beta: -1.9, 95% CI: -3.5 to -0.3), and Lancet (beta: -11.2, 95% CI: -14.7 to -7.8). Number of contributing countries increased in 3 journals: BMJ (beta: 0.8, 95% CI: 0.2 to 1.5), European Heart Journal (beta: -1.2, 95% CI: 0.8 to 1.7), and New England Journal of Medicine (beta: 1.6, 95% CI: 0.6 to 2.7). Fraction of collaborative publications increased (beta: 1.1 to 2.9) in all but Annals of Internal Medicine. Collaboration was associated with a higher median actual citation index (p general and specialty journals. Contribution by country in selected journals was disproportionate and under-represents total cardiovascular research in low- and middle-income countries. Copyright © 2014 World Heart Federation (Geneva). Published by Elsevier B.V. All rights reserved.

  15. Educational debt: does it have an influence on initial job location and specialty choice?

    Science.gov (United States)

    Snyder, Jennifer; Nehrenz, Guy; Danielsen, Randy; Pedersen, Donald

    2014-01-01

    This study applied a quantitative design and analyzed the impact of educational debt on initial specialty and location choices for physician assistant (PA) graduates in Indiana. PAs who graduated between January 1, 2000, and December 31, 2010, and actively practice in Indiana were surveyed. Descriptive statistics and chi-square analyses were performed to determine whether any significant relationships existed among practice specialty, location, and gender. 157 participants (33%) responded to the survey and were considered in the final analysis. Males were more likely than females to be influenced by debt in choosing their specialty and the location of their initial job. A majority of PAs would have reconsidered rural practice if they had received federal and or state loan forgiveness for educational debt. This study provides evidence that debt may influence practice specialty and location choice. Further studies are needed to determine how gender might account for decisions to practice in certain specialties and location.

  16. Calculating radiation exposures during use of (14)C-labeled nutrients, food components, and biopharmaceuticals to quantify metabolic behavior in humans.

    Science.gov (United States)

    Kim, Seung-Hyun; Kelly, Peter B; Clifford, Andrew J

    2010-04-28

    (14)C has long been used as a tracer for quantifying the in vivo human metabolism of food components, biopharmaceuticals, and nutrients. Minute amounts (food components, biopharmaceuticals, or nutrients to be organized into models suitable for quantitative hypothesis testing and determination of metabolic parameters. In vivo models are important for specification of intake levels for food components, biopharmaceuticals, and nutrients. Accurate estimation of the radiation exposure from ingested (14)C is an essential component of the experimental design. Therefore, this paper illustrates the calculation involved in determining the radiation exposure from a minute dose of orally administered (14)C-beta-carotene, (14)C-alpha-tocopherol, (14)C-lutein, and (14)C-folic acid from four prior experiments. The administered doses ranged from 36 to 100 nCi, and radiation exposure ranged from 0.12 to 5.2 microSv to whole body and from 0.2 to 3.4 microSv to liver with consideration of tissue weighting factor and fractional nutrient. In comparison, radiation exposure experienced during a 4 h airline flight across the United States at 37000 ft was 20 microSv.

  17. Stock market returns and clinical trial results of investigational compounds: an event study analysis of large biopharmaceutical companies.

    Science.gov (United States)

    Hwang, Thomas J

    2013-01-01

    For biopharmaceutical companies, investments in research and development are risky, and the results from clinical trials are key inflection points in the process. Few studies have explored how and to what extent the public equity market values clinical trial results. Our study dataset matched announcements of clinical trial results for investigational compounds from January 2011 to May 2013 with daily stock market returns of large United States-listed pharmaceutical and biotechnology companies. Event study methodology was used to examine the relationship between clinical research events and changes in stock returns. We identified public announcements for clinical trials of 24 investigational compounds, including 16 (67%) positive and 8 (33%) negative events. The majority of announcements were for Phase 3 clinical trials (N = 13, 54%), and for oncologic (N = 7, 29%) and neurologic (N = 6, 24%) indications. The median cumulative abnormal returns on the day of the announcement were 0.8% (95% confidence interval [CI]: -2.3, 13.4%; P = 0.02) for positive events and -2.0% (95% CI: -9.1, 0.7%; P = 0.04) for negative events, with statistically significant differences from zero. In the day immediately following the announcement, firms with positive events were associated with stock price corrections, with median cumulative abnormal returns falling to 0.4% (95% CI: -3.8, 12.3%; P = 0.33). For firms with negative announcements, the median cumulative abnormal returns were -1.7% (95% CI: -9.5, 1.0%; P = 0.03), and remained significantly negative over the two day event window. The magnitude of abnormal returns did not differ statistically by indication, by trial phase, or between biotechnology and pharmaceutical firms. The release of clinical trial results is an economically significant event and has meaningful effects on market value for large biopharmaceutical companies. Stock return underperformance due to negative events is greater in magnitude and persists longer than

  18. Trigeminal neuralgia--a coherent cross-specialty management program.

    Science.gov (United States)

    Heinskou, Tone; Maarbjerg, Stine; Rochat, Per; Wolfram, Frauke; Jensen, Rigmor Højland; Bendtsen, Lars

    2015-01-01

    Optimal management of patients with classical trigeminal neuralgia (TN) requires specific treatment programs and close collaboration between medical, radiological and surgical specialties. Organization of such treatment programs has never been described before. With this paper we aim to describe the implementation and feasibility of an accelerated cross-speciality management program, to describe the collaboration between the involved specialties and to report the patient flow during the first 2 years after implementation. Finally, we aim to stimulate discussions about optimal management of TN. Based on collaboration between neurologists, neuroradiologists and neurosurgeons a standardized program for TN was implemented in May 2012 at the Danish Headache Center (DHC). First out-patient visit and subsequent 3.0 Tesla MRI scan was booked in an accelerated manner. The MRI scan was performed according to a special TN protocol developed for this program. Patients initially referred to neurosurgery were re-directed to DHC for pre-surgical evaluation of diagnosis and optimization of medical treatment. Follow-up was 2 years with fixed visits where medical treatment and indication for neurosurgery was continuously evaluated. Scientific data was collected in a structured and prospective manner. From May 2012 to April 2014, 130 patients entered the accelerated program. Waiting time for the first out-patient visit was 42 days. Ninety-four percent of the patients had a MRI performed according to the special protocol after a mean of 37 days. Within 2 years follow-up 35% of the patients were referred to neurosurgery after a median time of 65 days. Five scientific papers describing demographics, clinical characteristics and neuroanatomical abnormalities were published. The described cross-speciality management program proved to be feasible and to have acceptable waiting times for referral and highly specialized work-up of TN patients in a public tertiary referral centre for headache

  19. Temperamental traits may be associated with medical students’ specialty preferences – pilot study

    Directory of Open Access Journals (Sweden)

    Agnieszka Pawełczyk

    2010-06-01

    Full Text Available Objective: This study was aimed at checking a hypothesis about a possible correlation between medical students’ temperamental traits and specialty preferences. Material and methods: The study was carried out among 202 students of the 6th year at the Medical University of Łódź in academic year 2008/2009. The examined group consisted of 140 women (69% and 62 men (31%. The average age of the students included into the study was 24.7 years (range: 23-29. The subjects were asked to fill in a questionnaire on demographic variables and the Formal Characteristics of BehaviourTemperament Inventory (FCB-TI by Zawadzki and Strelau. Results: The students taking part in the study preferred specialties in internal diseases (22%, surgery (18% and paediatrics (11%. Two point five percent of the students were indecisive in the specialty choice, 26% preferred surgical specialty and 71% – non-surgical specialty. Differences in temperamental traits were indicated between the students preferring different specialties. Students preferring surgery scored higher than those preferring internal medicine in Endurance (p=0.0036, d=0.63 and Activity (p=0.0292, d=0.63. Significantly higher average values were observed within two temperamental traits: Briskness (p=0.0083, d=0.5 and Endurance (p=0.0070, d=0.49 in students preferring surgical specialties, as compared to those choosing non-surgical specialties. Conclusions: Students’ preferring different medical specialties differ in temperamental traits. They obtained different results on the scales of Briskness, Endurance and Activity. The obtained results may be useful in vocational guidance within the choice of medical specialty.

  20. Integrated specialty service readiness in health reform: connections in haemophilia comprehensive care.

    Science.gov (United States)

    Pritchard, A M; Page, D

    2008-05-01

    The World Health Organization (WHO) has identified primary healthcare reform as a global priority whereby innovative practice changes are directed at improving health. This transformation to health reform in haemophilia service requires clarification of comprehensive care to reflect the WHO definition of health and key elements of primary healthcare reform. While comprehensive care supports effective healthcare delivery, comprehensive care must also be regarded beyond immediate patient management to reflect the broader system purpose in the care continuum with institutions, community agencies and government. Furthermore, health reform may be facilitated through integrated service delivery (ISD). ISD in specialty haemophilia care has the potential to reduce repetition of assessments, enhance care plan communication between providers and families, provide 24-h access to care, improve information availability regarding care quality and outcomes, consolidate access for multiple healthcare encounters and facilitate family self-efficacy and autonomy [1]. Three core aspects of ISD have been distinguished: clinical integration, information management and technology and vertical integration in local communities [2]. Selected examples taken from Canadian haemophilia comprehensive care illustrate how practice innovations are bridged with a broader system level approach and may support initiatives in other contexts. These innovations are thought to indicate readiness regarding ISD. Reflecting on the existing capacity of haemophilia comprehensive care teams will assist providers to connect and direct their existing strengths towards ISD and health reform.

  1. Health plan utilization and costs of specialty drugs within 4 chronic conditions.

    Science.gov (United States)

    Gleason, Patrick P; Alexander, G Caleb; Starner, Catherine I; Ritter, Stephen T; Van Houten, Holly K; Gunderson, Brent W; Shah, Nilay D

    2013-09-01

    Drugs are most typically defined as specialty because they are expensive; however, other criteria used to define a drug as specialty include biologic drugs, the need to inject or infuse the drug, the requirement for special handling, or drug availability only via a limited distribution network. Specialty drugs play an increasingly important role in the treatment of chronic conditions such as multiple sclerosis (MS), rheumatoid arthritis (RA), psoriasis, and inflammatory bowel disease (IBD), yet little is known regarding the comprehensive medical and pharmacy benefit utilization and cost trends for these conditions. To describe MS, RA, psoriasis, and IBD trends for condition prevalence, treatment with specialty drugs, specialty costs, nonspecialty costs, and total direct costs of care within the medical and pharmacy benefits. This was a descriptive analysis of a commercially insured population made up of 1 million members, using integrated medical and pharmacy administrative claims data from 2008 to 2010. Analyses were limited to continuously enrolled commercially insured individuals less than 65 years of age. Condition-specific cohorts for MS, RA, psoriasis, and IBD were defined using standardized criteria. Trends in condition prevalence, specialty drug use for the conditions, and direct total cost of care were analyzed. The direct costs were subcategorized into the following: medical benefit specialty drug costs, medical benefit all other costs, pharmacy benefit specialty drug costs, and pharmacy benefit all other costs. Trends and compound annual growth rates were calculated for the total cost of care and subcategory costs from 2008 through 2010. Condition prevalence ranged from a low of 1,720 per million members for MS to a high of 4,489 per million members for RA. Psoriasis and MS condition prevalence rates were unchanged over the 3 years; however, IBD prevalence increased 7.0%, and RA prevalence increased 9.7%. The rate of specialty drug use was lowest for IBD

  2. ENGINEERING SPECIALTY ASSESSMENT OF TANK WASTE COMPATIBILITY REPORTING

    International Nuclear Information System (INIS)

    KNIGHT, M.A.

    2003-01-01

    This Engineering Specialty Assessment was conducted to review the Tank Farm Waste Transfer Compatibility Program to assess whether the program meets the needs of accelerated retrieval and closure and waste feed delivery and to identify areas and methods for streamlining the program. The assessment was conducted in June 2003 and resulted in two findings and thirteen observations. The assessment results indicate that significant opportunities exist for streamlining the program by reducing the number of criteria requiring evaluation from 21 to 11, with only six of the criteria requiring evaluation for the majority of transfers. The assessment identified areas where existing criteria require strengthening to ensure that the risks of undesirable solids precipitation, from either waste mixing or waste transfer, are minimized. The assessment further identified opportunities for using existing engineering tools to simplify the calculations involved with preparation of waste compatibility assessments. The need to ensure that a revision to the waste compatibility program is prepared to align the program criteria with those that will be implemented with the DSA approval was also identified. Finally, the assessment identified that corrective actions are required to implement a tank-by-tank PCB inventory within the Best Basis Inventory and to ensure that sample data from external waste generators is entered into the TWINS database

  3. Predictors of Final Specialty Choice by Internal Medicine Residents

    Science.gov (United States)

    Diehl, Andrew K; Kumar, Vineeta; Gateley, Ann; Appleby, Jane L; O'Keefe, Mary E

    2006-01-01

    BACKGROUND Sociodemographic factors and personality attributes predict career decisions in medical students. Determinants of internal medicine residents' specialty choices have received little attention. OBJECTIVE To identify factors that predict the clinical practice of residents following their training. DESIGN Prospective cohort study. PARTICIPANTS Two hundred and four categorical residents from 2 university-based residency programs. MEASUREMENTS Sociodemographic and personality inventories performed during residency, and actual careers 4 to 9 years later. RESULTS International medical school graduates (IMGs) were less likely to practice general medicine than U.S. graduates (33.3% vs 70.6%, Pinternal medicine was observed among those who perceived General Internists to have lower potential incomes (69.0% vs 53.3%, P = .08). There was a trend for generalists to have lower scores on scales measuring authoritarianism, negative orientation to psychological problems, and Machiavellianism (0.05medicine, with trends apparent for higher debt (P = .05) and greater comfort caring for patients with psychological problems (P = .07). CONCLUSION Recruitment of IMGs may not increase the supply of General Internists. Prospects of lower income, even in the face of large debt, may not discourage residents from becoming generalists. If increasing generalist manpower is a goal, residencies should consider weighing applicants' personal attributes during the selection process. PMID:16836624

  4. Lipid components and oxidative status of selected specialty oils

    Directory of Open Access Journals (Sweden)

    P. Madawala, S. R.

    2012-06-01

    Full Text Available Many vegetable oils are marketed as specialty oils because of their retained flavors, tastes and distinct characteristics. Specialty oil samples which were commercially produced and retailed were purchased from local superstores in Reading, UK, and Uppsala, Sweden and profiled for detailed lipid composition and oxidative status. These oil samples include: almond, hazelnut, walnut, macadamia nut, argan, avocado, grape seed, roasted sesame, rice bran, cold pressed, organic and cold pressed, warm pressed and refined rapeseed oils. The levels of PV were quite low (0.5-1.3mEq O₂/kg but AV and Rancimat values at 100 °C (except for rapeseed oils varied considerably at (0.5-15.5 and (4.2-37.0 h respectively. Macadamia nut oil was found to be the most stable oil followed by argan oil, while walnut oil was the least stable. Among the specialty oils, macadamia nut oil had the lowest (4% and walnut oil had the highest (71% level of total PUFA. The organic cold pressed rapeseed oil had considerably lower PUFA (27% compared with other rapeseed oils (28- 35%. In all the samples, α- and γ- tocopherols were the major tocopherols; nut oils had generally lower levels. Total sterols ranged from 889 to 15,106 μg/g oil. The major sterols were β-sitosterol (61-85% and campesterol (6-20%. Argan oil contained schottenol (35% and spinasterol (32%. Compared with literature values, no marked differences were observed among the differently processed, organically grown or cold pressed rapeseed oils and other specialty oils in this study.

    Muchos aceites vegetales se venden como aceites especiales debido a su flavor, gusto y características distintas. Muestras de aceites especiales de almendra, avellana, nuez, nuez de macadamia, argán, aguacate, semillas de uva, de sésamo tostadas, salvado de arroz, y aceites orgánico de semillas de colza prensado en frío y, prensado caliente, y refinados que se producen y comercializan al por menor, se obtuvieron en

  5. Variability in Resident Operative Hand Experience by Specialty.

    Science.gov (United States)

    Silvestre, Jason; Lin, Ines C; Levin, L Scott; Chang, Benjamin

    2018-01-01

    Recent attention has sought to standardize hand surgery training in the United States. This study analyzes the variability in operative hand experience for orthopedic and general surgery residents. Case logs for orthopedic and general surgery residency graduates were obtained from the American Council of Graduate Medical Education (2006-2007 to 2014-2015). Plastic surgery case logs were not available for comparison. Hand surgery case volumes were compared between specialties with parametric tests. Intraspecialty variation in orthopedic surgery was assessed between the bottom and top 10th percentiles in procedure categories. Case logs for 9605 general surgery residents and 5911 orthopedic surgery residents were analyzed. Orthopedic surgery residents performed a greater number of hand surgery cases than general surgery residents ( P < .001). Mean total hand experience ranged from 2.5 ± 4 to 2.8 ± 5 procedures for general surgery residents with no reported cases of soft tissue repairs, vascular repairs, and replants. Significant intraspecialty variation existed in orthopedic surgery for all hand procedure categories (range, 3.3-15.0). As the model for hand surgery training evolves, general surgeons may represent an underutilized talent pool to meet the critical demand for hand surgeon specialists. Future research is needed to determine acceptable levels of training variability in hand surgery.

  6. Meals at medical specialty society annual meetings: a preliminary assessment.

    Science.gov (United States)

    La Puma, John; Schiedermayer, David; Becker, Jennifer

    2003-01-01

    Little isd known about how meals are chosen for medical meetings. We surveyed the annual meeting planners for 20 major specialty societies. Thirteen (65%) responded; all were currently planning their next meeting. Attendance in 2000 was reported at 113,477 physicians, with 2 million planned meals and snacks. No physician was named as responsible for food choices; the meeting planner and staff were primarily responsible for deciding what food to serve, excluding exhibit halls. Twelve (92%) respondents rated "available budget" as the most important factor. "Nutritional guidelines" were rated "very important" by eight of 13 (63%). However, no specific nutritional guidelines could be identified by any planner. All respondents indicated that members would attend a meeting if "healthy" food were the only option. For 2000, 100% of respondents indicated that for each lunch and for each dinner, a dessert had been included. No annual meeting and no planned 2001 meeting excluded potato chips, snack mixes, or candies at breaks; soda pop was offered at each break. Most respondents (89%) relied on a concluding questionnaire about the meeting facilities to evaluate the food. Respondents reported no difference in charges for "special meals," including vegetarian and kosher meals. Physicians may be unaware that some food served at medical meetings may impair learning, with excessive calorie, fat, and carbohydrate consumption. Small changes can improve the quality of food and beverages selected, without increased cost, and provide choices that conform to national nutritional guidelines. Medical meetings should serve flavorful, healthful food.

  7. Development of nurses with specialties: the nurse administrators' perspective.

    Science.gov (United States)

    Onishi, Mami; Sasaki, Minako; Nagata, Ayako; Kanda, Katsuya

    2008-10-01

    This study clarified how Japanese nurse administrators consider the current status and future prospects of development and utilization of nurses with specialties. The demand for specialized nurses is not satisfied throughout the country. Nine nurse administrators participated in three focus-group discussions. Data were analyzed using qualitative content analysis technique. On development of specialized nurses, four categories were abstracted: offering opportunities for career development; establishing an environment of life-term continuous learning; providing well-balanced support for the needs of organizations and individual nurses; and support for career development as a specialist. To develop specialized nurses effectively it is important to focus more attention on qualitative aspects of nurses' professional experience in in-service education and to support appropriate personnel for strategic human resource development. Facilitating frequent contacts between specialized and general nurses should be highly valued as making an environment where nurses can face career goals daily leads to steady preservation of human resources. It is necessary for nurse administrators to keep human resources quantitatively and to clarify the developmental process after nurses obtain special roles to plan for continuous education.

  8. Do the recommended standards for in vitro biopharmaceutic classification of drug permeability meet the "passive transport" criterion for biowaivers?

    Science.gov (United States)

    Žakelj, Simon; Berginc, Katja; Roškar, Robert; Kraljič, Bor; Kristl, Albin

    2013-01-01

    BCS based biowaivers are recognized by major regulatory agencies. An application for a biowaiver can be supported by or even based on "in vitro" measurements of drug permeability. However, guidelines limit the application of biowaivers to drug substances that are transported only by passive mechanisms. Regarding published permeability data as well as measurements obtained in our institution, one can rarely observe drug substances that conform to this very strict criterion. Therefore, we measured the apparent permeability coefficients of 13 drugs recommended by FDA's Guidance to be used as standards for "in vitro" permeability classification. The asymmetry of permeability data determined for both directions (mucosal-to-serosal and serosalto- mucosal) through the rat small intestine revealed significant active transport for four out of the nine high-permeability standards and for all four low-permeability standard drugs. As could be expected, this asymmetry was abolished at 4°C on rat intestine. The permeability of all nine high-permeability, but none of the low permeability standards, was also much lower when measured with intestinal tissue, Caco-2 cell monolayers or artificial membranes at 4°C compared to standard conditions (37°C). Additionally, concurrent testing of several standard drugs revealed that membrane transport can be affected by the use of internal permeability standards. The implications of the results are discussed regarding the regulatory aspects of biopharmaceutical classification, good practice in drug permeability evaluation and regarding the general relevance of transport proteins with broad specificity in drug absorption.

  9. Quantifying Trace Amounts of Aggregates in Biopharmaceuticals Using Analytical Ultracentrifugation Sedimentation Velocity: Bayesian Analyses and F Statistics.

    Science.gov (United States)

    Wafer, Lucas; Kloczewiak, Marek; Luo, Yin

    2016-07-01

    Analytical ultracentrifugation-sedimentation velocity (AUC-SV) is often used to quantify high molar mass species (HMMS) present in biopharmaceuticals. Although these species are often present in trace quantities, they have received significant attention due to their potential immunogenicity. Commonly, AUC-SV data is analyzed as a diffusion-corrected, sedimentation coefficient distribution, or c(s), using SEDFIT to numerically solve Lamm-type equations. SEDFIT also utilizes maximum entropy or Tikhonov-Phillips regularization to further allow the user to determine relevant sample information, including the number of species present, their sedimentation coefficients, and their relative abundance. However, this methodology has several, often unstated, limitations, which may impact the final analysis of protein therapeutics. These include regularization-specific effects, artificial "ripple peaks," and spurious shifts in the sedimentation coefficients. In this investigation, we experimentally verified that an explicit Bayesian approach, as implemented in SEDFIT, can largely correct for these effects. Clear guidelines on how to implement this technique and interpret the resulting data, especially for samples containing micro-heterogeneity (e.g., differential glycosylation), are also provided. In addition, we demonstrated how the Bayesian approach can be combined with F statistics to draw more accurate conclusions and rigorously exclude artifactual peaks. Numerous examples with an antibody and an antibody-drug conjugate were used to illustrate the strengths and drawbacks of each technique.

  10. Transgenic mammalian species, generated by somatic cell cloning, in biomedicine, biopharmaceutical industry and human nutrition/dietetics--recent achievements.

    Science.gov (United States)

    Samiec, M; Skrzyszowska, M

    2011-01-01

    Somatic cell cloning technology in mammals promotes the multiplication of productively-valuable genetically engineered individuals, and consequently allows also for standardization of transgenic farm animal-derived products, which, in the context of market requirements, will have growing significance. Gene farming is one of the most promising areas in modern biotechnology. The use of live bioreactors for the expression of human genes in the lactating mammary gland of transgenic animals seems to be the most cost-effective method for the production/processing of valuable recombinant therapeutic proteins. Among the transgenic farm livestock species used so far, cattle, goats, sheep, pigs and rabbits are useful candidates for the expression of tens to hundreds of grams of genetically-engineered proteins or xenogeneic biopreparations in the milk. At the beginning of the new millennium, a revolution in the treatment of disease is taking shape due to the emergence of new therapies based on recombinant human proteins. The ever-growing demand for such pharmaceutical or nutriceutical proteins is an important driving force for the development of safe and large-scale production platforms. The aim of this paper is to present an overall survey of the state of the art in investigations which provide the current knowledge for deciphering the possibilities of practical application of the transgenic mammalian species generated by somatic cell cloning in biomedicine, the biopharmaceutical industry, human nutrition/dietetics and agriculture.

  11. Chloroplast-derived vaccine antigens and biopharmaceuticals: protocols for expression, purification, or oral delivery and functional evaluation.

    Science.gov (United States)

    Singh, N Dolendro; Ding, Yi; Daniell, Henry

    2009-01-01

    Many vaccine antigens and biopharmaceutical proteins have been expressed at high levels via the chloroplast genome and their functionality has been evaluated using in vitro assays in cell cultures (i.e., macrophage lysis assay, inhibition of vesicular stomatitis virus-induced cytopathicity in baby hamster kidney cells, or inhibition of human HIV infection in TZM-BL cells) as well as protection after challenge with bacterial or viral pathogens or antitumor assays or delay the onset of insulitis in suitable animal models. Production of therapeutic proteins in chloroplasts eliminates the expensive fermentation technology. Moreover, oral delivery of chloroplast-derived therapeutic proteins eliminates expensive purification steps, cold storage, cold transportation, and delivery via sterile needles, thereby further decreasing their cost. In this chapter, we describe detailed protocols for chloroplast transformation including the construction of chloroplast transformation vectors, delivery of DNA into plant cells using particle bombardment, selection and regeneration of transformants by tissue culture, confirmation of transgene integration into the chloroplast genome and homoplasmy, evaluation of foreign gene expression, purification of foreign protein, or oral delivery via bioencapsulation, functional evaluation using in vitro and in vivo assays, and evaluation of immunity after challenge with pathogens in suitable animal models.

  12. Gender difference in preference of specialty as a career choice among Japanese medical students.

    Science.gov (United States)

    Kawamoto, Ryuichi; Ninomiya, Daisuke; Kasai, Yoshihisa; Kusunoki, Tomo; Ohtsuka, Nobuyuki; Kumagi, Teru; Abe, Masanori

    2016-11-10

    In Japan, the absolute deficiency of doctors and maldistribution of doctors by specialty is a significant problem in the Japanese health care system. The purpose of this study was to investigate the factors contributing to specialty preference in career choice among Japanese medical students. A total of 368 medical students completed the survey giving an 88.2 % response rate. The subjects comprised 141 women aged 21 ± 3 (range, 18-34) years and 227 men aged 22 ± 4 (range, 18-44) years. Binary Logistic regression analysis was performed using specialty preferences as the criterion variable and the factors in brackets as six motivational variables (e.g., Factor 1: educational experience; Factor 2: job security; Factor 3: advice from others; Factor 4: work-life balance; Factor 5: technical and research specialty; and Factor 6: personal reasons). Women significantly preferred pediatrics, obstetrics & gynecology, and psychology than the men. Men significantly preferred surgery and orthopedics than the women. For both genders, a high odds ratio (OR) of "technical & research specialty" and a low OR for "personal reasons" were associated with preference for surgery. "Technical & research specialty" was positively associated with preference for special internal medicine and negatively for pediatrics. "Work-life balance" was positively associated with preference for psychology and negatively for emergency medicine. Among the women only, "technical & research specialty" was negatively associated with preference for general medicine/family medicine and obstetrics & gynecology, and "job security" was positively associated for general medicine/family medicine and negatively for psychology. Among men only, "educational experience" and "personal reasons" were positively, and "job security" was negatively associated with preference for pediatrics. For both genders, "work-life balance" was positively associated with preference for controllable lifestyle specialties. We

  13. Specialties differ in which aspects of doctor communication predict overall physician ratings.

    Science.gov (United States)

    Quigley, Denise D; Elliott, Marc N; Farley, Donna O; Burkhart, Q; Skootsky, Samuel A; Hays, Ron D

    2014-03-01

    Effective doctor communication is critical to positive doctor-patient relationships and predicts better health outcomes. Doctor communication is the strongest predictor of patient ratings of doctors, but the most important aspects of communication may vary by specialty. To determine the importance of five aspects of doctor communication to overall physician ratings by specialty. For each of 28 specialties, we calculated partial correlations of five communication items with a 0-10 overall physician rating, controlling for patient demographics. Consumer Assessment of Healthcare Providers and Systems Clinician and Group (CG-CAHPS®) 12-month Survey data collected 2005-2009 from 58,251 adults at a 534-physician medical group. CG-CAHPS includes a 0 ("Worst physician possible") to 10 ("Best physician possible") overall physician rating. Five doctor communication items assess how often the physician: explains things; listens carefully; gives easy-to-understand instructions; shows respect; and spends enough time. Physician showing respect was the most important aspect of communication for 23/28 specialties, with a mean partial correlation (0.27, ranging from 0.07 to 0.44 across specialties) that accounted for more than four times as much variance in the overall physician rating as any other communication item. Three of five communication items varied significantly across specialties in their associations with the overall rating (p importance of other aspects of communication varied significantly by specialty. Quality improvement efforts by all specialties should emphasize physicians showing respect to patients, and each specialty should also target other aspects of communication that matter most to their patients. The results have implications for improving provider quality improvement and incentive programs and the reporting of CAHPS data to patients. Specialists make important contributions to coordinated patient care, and thus customized approaches to measurement

  14. Providing Specialty Care for the Poor and Underserved at Student-Run Free Clinics in the San Francisco Bay Area.

    Science.gov (United States)

    Liu, Max Bolun; Xiong, Grace; Boggiano, Victoria Lynn; Ye, Patrick Peiyong; Lin, Steven

    2017-01-01

    This report describes the model of specialty clinics implemented at Stanford University's two student-run free clinics, Arbor Free Clinic and Pacific Free Clinic, in the San Francisco Bay Area. We describe our patient demographic characteristics and the specialty services provided. We discuss challenges in implementing specialty care at student-run free clinics.

  15. Medical specialty considerations by medical students early in their clinical experience

    Directory of Open Access Journals (Sweden)

    Weissman Charles

    2012-03-01

    Full Text Available Abstract Background Specialty selection by medical students determines the future composition of the physician workforce. Selection of career specialties begins in earnest during the clinical rotations with exposure to the clinical and intellectual environments of various specialties. Career specialty selection is followed by choosing a residency program. This is the period where insight into the decision process might help healthcare leaders ascertain whether, when, and how to intervene and attempt to influence students' decisions. The criteria students consider important in selecting a specialty and a residency program during the early phases of their clinical rotations were examined. Methods Questionnaires distributed to fifth-year medical students at two Israeli medical schools. Results 229 of 275 (83% questionnaires were returned. 80% of the students had considered specialties; 62% considered one specialty, 25% two, the remainder 3-5 specialties. Students took a long-range view; 55% considered working conditions after residency more important than those during residency, another 42% considered both equally important. More than two-thirds wanted an interesting and challenging bedside specialty affording control over lifestyle and providing a reasonable relationship between salary and lifestyle. Men were more interested in well-remunerated procedure-oriented specialties that allowed for private practice. Most students rated as important selecting a challenging and interesting residency program characterized by good relationships between staff members, with positive treatment by the institution, and that provided much teaching. More women wanted short residencies with few on-calls and limited hours. More men rated as important residencies affording much responsibility for making clinical decisions and providing research opportunities. More than 50% of the students considered it important that their residency be in a leading department, and in

  16. Satellite Estimation of Fractional Cover in Several California Specialty Crops

    Science.gov (United States)

    Johnson, L.; Cahn, M.; Rosevelt, C.; Guzman, A.; Lockhart, T.; Farrara, B.; Melton, F. S.

    2016-12-01

    Past research in California and elsewhere has revealed strong relationships between satellite NDVI, photosynthetically active vegetation fraction (Fc), and crop evapotranspiration (ETc). Estimation of ETc can support efficiency of irrigation practice, which enhances water security and may mitigate nitrate leaching. The U.C. Cooperative Extension previously developed the CropManage (CM) web application for evaluation of crop water requirement and irrigation scheduling for several high-value specialty crops. CM currently uses empirical equations to predict daily Fc as a function of crop type, planting date and expected harvest date. The Fc prediction is transformed to fraction of reference ET and combined with reference data from the California Irrigation Management Information System to estimate daily ETc. In the current study, atmospherically-corrected Landsat NDVI data were compared with in-situ Fc estimates on several crops in the Salinas Valley during 2011-2014. The satellite data were observed on day of ground collection or were linearly interpolated across no more than an 8-day revisit period. Results will be presented for lettuce, spinach, celery, broccoli, cauliflower, cabbage, peppers, and strawberry. An application programming interface (API) allows CM and other clients to automatically retrieve NDVI and associated data from NASA's Satellite Irrigation Management Support (SIMS) web service. The SIMS API allows for queries both by individual points or user-defined polygons, and provides data for individual days or annual timeseries. Updates to the CM web app will convert these NDVI data to Fc on a crop-specific basis. The satellite observations are expected to play a support role in Salinas Valley, and may eventually serve as a primary data source as CM is extended to crop systems or regions where Fc is less predictable.

  17. Specialty Payment Model Opportunities and Assessment: Oncology Model Design Report.

    Science.gov (United States)

    Huckfeldt, Peter J; Chan, Chris; Hirshman, Samuel; Kofner, Aaron; Liu, Jodi L; Mulcahy, Andrew W; Popescu, Ioana; Stevens, Clare; Timbie, Justin W; Hussey, Peter S

    2015-07-15

    This article describes research related to the design of a payment model for specialty oncology services for possible testing by the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services (CMS). Cancer is a common and costly condition. Episode-based payment, which aims to create incentives for high-quality, low-cost care, has been identified as a promising alternative payment model for oncology care. Episode-based payment systems can provide flexibility to health care providers to select among the most effective and efficient treatment alternatives, including activities that are not currently reimbursed under Medicare payment policies. However, the model design also needs to ensure that high-quality care is delivered and that beneficial treatments are not withheld from patients. CMS asked MITRE and RAND to conduct analyses to inform design decisions related to an episode-based oncology model for Medicare beneficiaries undergoing chemotherapy treatment for cancer. In particular, this study focuses on analyses of Medicare claims data related to the definition of the initiation of an episode of chemotherapy, patterns of spending during and surrounding episodes of chemotherapy, and attribution of episodes of chemotherapy to physician practices. We found that the time between the primary cancer diagnosis and chemotherapy initiation varied widely across patients, ranging from one day to over seven years, with a median of 2.4 months. The average level of total monthly payments varied considerably across cancers, with the highest spending peak of $9,972 for lymphoma, and peaks of $3,109 for breast cancer and $2,135 for prostate cancer.

  18. Specialty Payment Model Opportunities and Assessment: Oncology Simulation Report.

    Science.gov (United States)

    White, Chapin; Chan, Chris; Huckfeldt, Peter J; Kofner, Aaron; Mulcahy, Andrew W; Pollak, Julia; Popescu, Ioana; Timbie, Justin W; Hussey, Peter S

    2015-07-15

    This article describes the results of a simulation analysis of a payment model for specialty oncology services that is being developed for possible testing by the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services (CMS). CMS asked MITRE and RAND to conduct simulation analyses to preview some of the possible impacts of the payment model and to inform design decisions related to the model. The simulation analysis used an episode-level dataset based on Medicare fee-for-service (FFS) claims for historical oncology episodes provided to Medicare FFS beneficiaries in 2010. Under the proposed model, participating practices would continue to receive FFS payments, would also receive per-beneficiary per-month care management payments for episodes lasting up to six months, and would be eligible for performance-based payments based on per-episode spending for attributed episodes relative to a per-episode spending target. The simulation offers several insights into the proposed payment model for oncology: (1) The care management payments used in the simulation analysis-$960 total per six-month episode-represent only 4 percent of projected average total spending per episode (around $27,000 in 2016), but they are large relative to the FFS revenues of participating oncology practices, which are projected to be around $2,000 per oncology episode. By themselves, the care management payments would increase physician practices' Medicare revenues by roughly 50 percent on average. This represents a substantial new outlay for the Medicare program and a substantial new source of revenues for oncology practices. (2) For the Medicare program to break even, participating oncology practices would have to reduce utilization and intensity by roughly 4 percent. (3) The break-even point can be reduced if the care management payments are reduced or if the performance-based payments are reduced.

  19. The Emergence and Development of the Sociology of Sport as an Academic Specialty.

    Science.gov (United States)

    Loy, John W.; And Others

    1980-01-01

    Sport sociology as an academic specialty and its stages of development are described. Problems confronting future developments in sport sociology include critical mass, academic status, and ideological orientation, both in physical education and in sociology. (CJ)

  20. CLASSIFICATION OF SPECIALTIES AND QUALIFICATIONS IN REPUBLIC OF BELARUS: TENDENCIES AND PROSPECTS

    Directory of Open Access Journals (Sweden)

    O. A. Oleks

    2016-01-01

    Full Text Available In the present publication short data on the system of specialties and qualifications functioning in Republic of Belarus, her features, scope of application are given. The purpose and problems of the revision of the National classifier of the Republic of Belarus «Specialties and qualifications», its orientation to reduce the gap between the content of education and content of activity of graduates of establishments of education are described. The main tendencies of change of the operating classification – on the basis of types of economic activity and international standard classification of education taking into account requirements of employers, minimization of economic expenses for education, including due to minimization of classification units, rapprochement of positions with educational systems of other states are revealed. Prospects of development of national system of specialties and qualifications are disclosed. Tendencies and prospects of the expected changes are shown on the examples of the certain specialties offered by BNTU (Belarusian National Technical University.

  1. Forecasting U.S. Marine Corps Reenlistments by Military Occupational Specialty and Grade

    National Research Council Canada - National Science Library

    Conatser, Dean G

    2006-01-01

    .... Currently the First Term Alignment Plan (FTAP) Model and Subsequent Term Alignment Plan (STAP) Model are used to determine the number of required reenlistments by Marine military occupational specialty...

  2. Are new medical students' specialty preferences gendered? Related motivational factors at a Dutch medical school.

    NARCIS (Netherlands)

    Tongeren-Alers, M.L.G. van; Esch, M. van der; Verdonk, P.; Johansson, E.; Hamberg, K.; Lagro-Janssen, T.

    2011-01-01

    BACKGROUND: Female students currently outnumber male students in most medical schools. Some medical specialties are highly gender segregated. Therefore, it is interesting to know whether medical students have early specialization preferences based on their gender. Consequently, we like to know

  3. 78 FR 10608 - David Grant United States Air Force Medical Center Specialty Care Travel Reimbursement...

    Science.gov (United States)

    2013-02-14

    ... principle of the TRICARE program and the Military Health System (MHS) business design is that MTFs have... identified specialties. There will also be quarterly tracking of marketing initiatives to measure their...

  4. Social media in the mentorship and networking of physicians: Important role for women in surgical specialties.

    Science.gov (United States)

    Luc, Jessica G Y; Stamp, Nikki L; Antonoff, Mara B

    2018-04-01

    Social media may be a useful supplement to physician and trainee interactions; however, its role in enhancing mentorship has not been described. A 35-item survey investigating trainee and physician social media use was distributed. Responses were analyzed using descriptive statistics. 282 respondents completed the survey, among whom 136 (48.2%) reported careers in surgical specialties. Women in surgical specialties were more likely to describe the specialty as being dominated by the opposite sex (p media to build a network of same-sex mentorship (p = 0.031). Social media serves as a valuable tool to enhance the networking and mentorship of surgeons, particularly for women in surgical specialties who may lack exposure to same-sex mentors at their own institution. Copyright © 2018 Elsevier Inc. All rights reserved.

  5. Application-specific specialty microstructured optical fibers for mid-IR and THz photonics (Invited)

    DEFF Research Database (Denmark)

    Pal, Bishnu P.; Barh, Ajanta; Varshney, Ravi K.

    2016-01-01

    A review of several of our designed specialty microstructured optical fibers (MOFs) for mid-IR and THz generation and transmission including high power transmission is presented. Extensive results on performance of the designed MOFs are described....

  6. THE SPECIALTY OF EMERGENCY MEDICINE IN CHILE: 20 YEARS OF HISTORY

    Directory of Open Access Journals (Sweden)

    WK Mallon

    2017-03-01

    Full Text Available Chile is uniquely situated to be a leader in South American development of the specialty of Emergency Medicine. Chilean emergency medicine has successfully transitioned from a novelty training idea to a nationally and internationally recognized entity with serious public health goals. There are more residency training programs in Chile than in any other South American or Latin American country, and the specialty is formally recognized by the Ministry of Health. Chilean emergency medicine thought leaders have networked internationally with multiple groups, intelligently used outside resources, and created durable academic relationships. While focusing on locally important issues and patient care they have successfully advanced their agenda. Despite this, the specialty faces many new challenges and remains fragile but sustainable. Policy makers and the Chilean MOH need to be acutely aware of this fragility to preserve the progress achieved so far, and support ongoing maturation of the specialty of Emergency Medicine.

  7. The Impact of HIV/AIDS Epidemic on the Choice of Specialties ...

    African Journals Online (AJOL)

    The Impact of HIV/AIDS Epidemic on the Choice of Specialties among Medical ... satisfaction and favourable work schedule respectively. ... We recommend improvements in the work environment and adherence to universal precautions to

  8. 48 CFR 252.225-7008 - Restriction on Acquisition of Specialty Metals.

    Science.gov (United States)

    2010-10-01

    ... CLAUSES Text of Provisions And Clauses 252.225-7008 Restriction on Acquisition of Specialty Metals. As... more of the following limits: Manganese, 1.65 percent; silicon, 0.60 percent; or copper, 0.60 percent...

  9. 8. Seminar of the IMP-IIE-ININ on technological specialties. Topic 10: Earth Sciences

    International Nuclear Information System (INIS)

    1996-01-01

    The document contains two papers within INIS subject scope which were presented at the 8th Seminar of the IMP-IIE-ININ on technological specialties. Topic 10: Earth Sciences. A separate abstract was prepared for each paper

  10. Oncofertility: A New Medical Specialty Helping Young Cancer Patients Have Children

    Science.gov (United States)

    ... Oncofertility: A New Medical Specialty Helping Young Cancer Patients Have Children Past Issues / Fall 2014 Table of ... old problem: the fertility needs of young cancer patients. The word itself was coined through NIH-sponsored ...

  11. Routine Prenatal Care Visits by Provider Specialty in the United States, 2009-2010

    Science.gov (United States)

    ... and are not in the specialties of anesthesiology, pathology, or radiology. The NAMCS physician response rate was ... last reviewed: November 6, 2015 Page last updated: March 13, 2014 Content source: Email Recommend Tweet YouTube ...

  12. Medical specialty selection criteria of Israeli medical students early in their clinical experience: subgroups.

    Science.gov (United States)

    Avidan, Alexander; Weissman, Charles; Elchalal, Uriel; Tandeter, Howard; Zisk-Rony, Rachel Yaffa

    2018-04-18

    Israeli medical school classes include a number of student subgroups. Therefore, interventions aimed at recruiting medical students to the various specialties should to be tailored to each subgroup. Questionnaires, distributed to 6 consecutive 5th-year classes of the Hebrew University - Hadassah School of Medicine, elicited information on criteria for choosing a career specialty, criteria for choosing a residency program and the importance of finding a specialty interesting and challenging when choosing a residency. Completed questionnaires were returned by 540 of 769 (70%) students. The decision processes for choosing a medical specialty and choosing a residency program were different. Family and colleagues had minimal influence on choosing a specialty, while family and their residential locality had much influence on choosing a residency, especially among women. Older age, marriage, and spousal influence were positively associated with choice of a specialty. Two-thirds of the students had completed military service, 20% were attending medical school prior to military service, 5% had completed national service and 9% had entered medical school without serving. Despite the pre-military subgroup being younger and having another 7 years of medical school, internship and military service before residency, they had begun thinking about which specialty to choose, just like the post-military students. When choosing a residency program, post-military women were more influenced by their families and family residential locality than their pre-military counterparts; differences ascribed to the older and often married post-military women having or wanting to begin families. This difference was reinforced by fewer post- than pre-military women willing to wait 2-3 years for a residency in the specialty that interested them most and were willing to begin residency immediately after internship in a specialty that interested them less. Medical school classes are composed of

  13. Recent patents in plant biotechnology: impact on global health.

    Science.gov (United States)

    Hefferon, Kathleen L

    2012-08-01

    Agricultural biotechnology offers a robust series of tools by which to address global concerns such as food security, crop protection, and fuel/energy requirements. A number of advances made recently in plant molecular biology also have resulted in applications which largely focus on improving global human health. This review describes some of the recent innovations in plant biotechnology that have come to the forefront over the past year. Included are novel techniques by which plants can be improved as platforms for biopharmaceutical protein production, a growing field also referred to as 'molecular pharming'. The metabolic engineering of plants to produce compounds which have additional nutritional benefits is also outlined. The review concludes with a discussion of the future impact that these innovations may have both on global health and on the development of our future intellectual property landscape.

  14. Factors influencing the implementation, adoption, use, sustainability and scalability of eLearning for family medicine specialty training: a systematic review protocol.

    Science.gov (United States)

    Cotič, Živa; Rees, Rebecca; Wark, Petra A; Car, Josip

    2016-10-19

    In 2013, there was a shortage of approximately 7.2 million health workers worldwide, which is larger among family physicians than among specialists. eLearning could provide a potential solution to some of these global workforce challenges. However, there is little evidence on factors facilitating or hindering implementation, adoption, use, scalability and sustainability of eLearning. This review aims to synthesise results from qualitative and mixed methods studies to provide insight on factors influencing implementation of eLearning for family medicine specialty education and training. Additionally, this review aims to identify the actions needed to increase effectiveness of eLearning and identify the strategies required to improve eLearning implementation, adoption, use, sustainability and scalability for family medicine speciality education and training. A systematic search will be conducted across a range of databases for qualitative studies focusing on experiences, barriers, facilitators, and other factors related to the implementation, adoption, use, sustainability and scalability of eLearning for family medicine specialty education and training. Studies will be synthesised by using the framework analysis approach. This study will contribute to the evaluation of eLearning implementation, adoption, use, sustainability and scalability for family medicine specialty training and education and the development of eLearning guidelines for postgraduate medical education. PROSPERO http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016036449.

  15. How are the different specialties represented in the major journals in general medicine?

    Science.gov (United States)

    Gehanno, Jean-Francois; Ladner, Joel; Rollin, Laetitia; Dahamna, Badisse; Darmoni, Stefan J

    2011-01-21

    General practitioners and medical specialists mainly rely on one "general medical" journal to keep their medical knowledge up to date. Nevertheless, it is not known if these journals display the same overview of the medical knowledge in different specialties. The aims of this study were to measure the relative weight of the different specialties in the major journals of general medicine, to evaluate the trends in these weights over a ten-year period and to compare the journals. The 14,091 articles published in The Lancet, the NEJM, the JAMA and the BMJ in 1997, 2002 and 2007 were analyzed. The relative weight of the medical specialities was determined by categorization of all the articles, using a categorization algorithm which inferred the medical specialties relevant to each article MEDLINE file from the MeSH terms used by the indexers of the US National Library of Medicine to describe each article. The 14,091 articles included in our study were indexed by 22,155 major MeSH terms, which were categorized into 81 different medical specialties. Cardiology and Neurology were in the first 3 specialties in the 4 journals. Five and 15 specialties were systematically ranked in the first 10 and first 20 in the four journals respectively. Among the first 30 specialties, 23 were common to the four journals. For each speciality, the trends over a 10-year period were different from one journal to another, with no consistency and no obvious explanatory factor. Overall, the representation of many specialties in the four journals in general and internal medicine included in this study may differ, probably due to different editorial policies. Reading only one of these journals may provide a reliable but only partial overview.

  16. Some theoretic elements about vocational guidance in the specialty Carpintería

    Directory of Open Access Journals (Sweden)

    Odelmi Miló García

    2016-03-01

    Full Text Available Presently article the methodological conceptual theoretical bases are presented that sustain in an essential way the cultural historical theory, The objective of the same one is to elaborate a methodological strategy for the development of the professional orientation toward the specialty carpentry in students of the first year of the Polytechnic Leonides Blanco González, being given the problem that the students are not motivated by the specialty.

  17. Gender Distribution Among American Board of Medical Specialties Boards of Directors.

    Science.gov (United States)

    Walker, Laura E; Sadosty, Annie T; Colletti, James E; Goyal, Deepi G; Sunga, Kharmene L; Hayes, Sharonne N

    2016-11-01

    Since 1995, women have comprised more than 40% of all medical school graduates. However, representation at leadership levels in medicine remains considerably lower. Gender representation among the American Board of Medical Specialties (ABMS) boards of directors (BODs) has not previously been evaluated. Our objective was to determine the relative representation of women on ABMS BODs and compare it with the in-training and in-practice gender composition of the respective specialties. The composition of the ABMS BODs was obtained from websites in March 2016 for all Member Boards. Association of American Medical Colleges and American Medical Association data were utilized to identify current and future trends in gender composition. Although represented by a common board, neurology and psychiatry were evaluated separately because of their very different practices and gender demographic characteristics. A total of 25 specialties were evaluated. Of the 25 specialties analyzed, 12 BODs have proportional gender representation compared with their constituency. Seven specialties have a larger proportion of women serving on their boards compared with physicians in practice, and 6 specialties have a greater proportion of men populating their BODs. Based on the most recent trainee data (2013), women have increasing workforce representation in almost all specialties. Although women in both training and practice are approaching equal representation, there is variability in gender ratios across specialties. Directorship within ABMS BODs has a more equitable gender distribution than other areas of leadership in medicine. Further investigation is needed to determine the reasons behind this difference and to identify opportunities to engage women in leadership in medicine. Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  18. Surgery or general medicine: a study of the reasons underlying the choice of medical specialty

    Directory of Open Access Journals (Sweden)

    Patrícia Lacerda Bellodi

    Full Text Available CONTEXT: The reality of medical services in Brazil points towards expansion and diversification of medical knowledge. However, there are few Brazilian studies on choosing a medical specialty. OBJECTIVE: To investigate and characterize the process of choosing the medical specialty among Brazilian resident doctors, with a comparison of the choice between general medicine and surgery. TYPE OF STUDY: Stratified survey. SETTING: Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (HC-FMUSP. METHODS: A randomized sample of resident doctors in general medicine (30 and surgery (30 was interviewed. Data on sociodemographic characteristics and the moment, stability and reasons for the choice of specialty were obtained. RESULTS: The moment of choice between the two specialties differed. Surgeons (30% choose the specialty earlier, while general doctors decided progressively, mainly during the internship (43%. Most residents in both fields (73% general medicine, 70% surgery said they had considered another specialty before the current choice. The main reasons for general doctors' choice were contact with patients (50%, intellectual activities (30% and knowledge of the field (27%. For surgeons the main reasons were practical intervention (43%, manual activities (43% and the results obtained (40%. Personality was important in the choice for 20% of general doctors and for 27% of surgeons. DISCUSSION: The reasons found for the choice between general medicine and surgery were consistent with the literature. The concepts of wanting to be a general doctor or a surgeon are similar throughout the world. Personality characteristics were an important influencing factor for all residents, without statistical difference between the specialties, as was lifestyle. Remuneration did not appear as a determinant. CONCLUSION: The results from this group of Brazilian resident doctors corroborated data on choosing a medical specialty from other countries

  19. Current and future funding sources for specialty mental health and substance abuse treatment providers.

    Science.gov (United States)

    Levit, Katharine R; Stranges, Elizabeth; Coffey, Rosanna M; Kassed, Cheryl; Mark, Tami L; Buck, Jeffrey A; Vandivort-Warren, Rita

    2013-06-01

    Goals were to describe funding for specialty behavioral health providers in 1986 and 2005 and examine how the recession, parity law, and Affordable Care Act (ACA) may affect future funding. Numerous public data sets and actuarial methods were used to estimate spending for services from specialty behavioral health providers (general hospital specialty units; specialty hospitals; psychiatrists; other behavioral health professionals; and specialty mental health and substance abuse treatment centers). Between 1986 and 2005, hospitals-which had received the largest share of behavioral health spending-declined in importance, and spending shares trended away from specialty hospitals that were largely funded by state and local governments. Hospitals' share of funding from private insurance decreased from 25% in 1986 to 12% in 2005, and the Medicaid share increased from 11% to 23%. Office-based specialty providers continued to be largely dependent on private insurance and out-of-pocket payments, with psychiatrists receiving increased Medicaid funding. Specialty centers received increased funding shares from Medicaid (from 11% to 29%), and shares from other state and local government sources fell (from 64% to 46%). With ACA's full implementation, spending on behavioral health will likely increase under private insurance and Medicaid. Parity in private plans will also push a larger share of payments for office-based professionals from out-of-pocket payments to private insurance. As ACA provides insurance for formerly uninsured individuals, funding by state behavioral health authorities of center-based treatment will likely refocus on recovery and support services. Federal Medicaid rules will increase in importance as more people needing behavioral health treatment become covered.

  20. Stability of and Factors Related to Medical Student Specialty Choice of Psychiatry.

    Science.gov (United States)

    Goldenberg, Matthew N; Williams, D Keith; Spollen, John J

    2017-09-01

    Targeted efforts are needed to increase the number of medical students choosing psychiatry, but little is known about when students decide on their specialty or what factors influence their choice. The authors examined the timing and stability of student career choice of psychiatry compared with other specialties and determined what pre- and intra-medical school factors were associated with choosing a career in psychiatry. Using survey data from students who graduated from U.S. allopathic medical schools in 2013 and 2014 (N=29,713), the authors computed rates of psychiatry specialty choice at the beginning and end of medical school and assessed the stability of that choice. A multivariate-adjusted logistic regression and recursive partitioning were used to determine the association of 29 factors with psychiatry specialty choice. Choice of psychiatry increased from 1.6% at the start of medical school to 4.1% at graduation. The stability of psychiatry specialty choice from matriculation to graduation, at just over 50%, was greater than for any other specialty. However, almost 80% of future psychiatrists did not indicate an inclination toward the specialty at matriculation. A rating of "excellent" for the psychiatry clerkship (odds ratio=2.66), a major in psychology in college (odds ratio=2.58), and valuing work-life balance (odds ratio=2.25) were the factors most strongly associated with psychiatry career choice. Students who enter medical school planning to become psychiatrists are likely to do so, but the vast majority of students who choose psychiatry do so during medical school. Increasing the percentage of medical students with undergraduate psychology majors and providing an exemplary psychiatry clerkship are modifiable factors that may increase the rate of psychiatry specialty choice.

  1. Ideal versus real conditions for type 2 diabetes care : diabetes specialty nurses’ perspectives

    OpenAIRE

    Jutterström, Lena; Hällgren Graneheim, Ulla; Isaksson, Ulf; Hörnsten, Åsa

    2012-01-01

    Background: Since diabetes specialty nurses are the professionals who spend the most time with patients living with diabetes, they probably have the greatest influence on the quality of diabetes care. Therefore, their personal perceptions about what constitutes “good care” in type 2 diabetes care are important to explore. Aim: The aim of this study was to describe conditions for “good care” in type 2-diabetes as perceived by diabetes specialty nurses. Method: Twenty-one experienced diabetes s...

  2. The study of base and surface-active substances influence on biopharmaceutical characteristics of suppository with praziquantel

    Directory of Open Access Journals (Sweden)

    D. M. Romanina

    2016-12-01

    Full Text Available Acne dermatoses (rosacea, perioral dermatitis, seborrheic dermatitis etc. are one of the most actual problems in dermatology. Praziquantel is an antiparasitic medication effective towards trematodes, cestodes. Investigations developed by domestic scientists revealed antidemodicosis activity of praziquantel. Use of semisolid dosage forms for rectal administration will allow to increase its efficacy and minimize the risks of adverse reactions. The aim of this work is the study of influence of excipients (bases and surfactants use in suppository manufacturing on the biopharmaceutical characteristics of praziquantel rectal dosage form. Methods and results. As excipients for praziquantel rectal dosage form we have investigated suppository bases and surfactants, which are widely used in manufacturing and compounding of semisolid dosage forms and are described in literature. Suppositories were made by the fusion method. Concentration of surfactants in all compositions was 2%, praziquantel – 0,6 g on one suppository. Investigation was carried out by the 2-factors dispersive analysis with repeated observations. Suppository compounding was carried out by the suspension type. After thorough pulverization of praziquantel, it was mixed with some part of the base and then obtained mixture was added to the all melted base. As optimization parameter the praziquantel releasing was chosen as the first step of bioavailability investigation. Praziquantel releasing from suppository was studied by the equilibrium dialysis by Kruvchinsky. Ethyl alcohol was chosen as a dialysis medium considering the solubility of praziquantel. Concentration of released praziquantel after 30 minutes of the dialysis was determined by spectrophotometric analysis. Conclusion. It has been established that the sort of the base and surfactant have significant influence on praziquantel releasing from rectal suppository. It has been revealed that sort of base has the greatest influence on

  3. Acceptability and characteristics of 124 human bioequivalence studies with active substances classified according to the Biopharmaceutic Classification System

    Science.gov (United States)

    Ramirez, Elena; Laosa, Olga; Guerra, Pedro; Duque, Blanca; Mosquera, Beatriz; Borobia, Alberto M; Lei, Suhua H; Carcas, Antonio J; Frias, Jesus

    2010-01-01

    AIM The aim of this study was to evaluate the acceptability of 124 bioequivalence (BE) studies with 80 active substances categorized according to the Biopharmaceutics Classification System (BCS) in order to establish if there were different probabilities of proving BE between the different BCS classes. METHODS We evaluated the differences between pharmaceutical products with active substances from different BCS classes in terms of acceptability, number of subjects in the study (n), the point estimates, and intra- and inter-subject coefficients of variation data from BE studies with generic products. RESULTS Out of 124 BE studies 89 (71.77%) were performed with pharmaceutical products containing active substances classified by the BCS. In all BCS classes there were non-bioequivalent pharmaceutical products: 4 out of 26 (15.38%) in class 1, 14 out of 28 (50%) in class 2, 3 out of 22 (13.63%) in class 3 and 1 out of 13 (7.69%) in class 4. When we removed those pharmaceutical products in which intra-subject variability was higher than predicted (2 in class 1 active substances, 9 in class 2 and 2 in class 3) there were still non-BE pharmaceutical products in classes 1, 2 and 3. CONCLUSIONS Comparisons between pharmaceutical products with active substances from the four BCS classes have not allowed us to define differential characteristics of each class in terms of n, inter and intra-subject variability for Cmax or AUC. Despite the usually employed test dissolution methodology proposed as quality control, pharmaceutical products with active substances from the four classes of BCS showed non-BE studies. PMID:21039763

  4. Intestinal permeability study of minoxidil: assessment of minoxidil as a high permeability reference drug for biopharmaceutics classification.

    Science.gov (United States)

    Ozawa, Makoto; Tsume, Yasuhiro; Zur, Moran; Dahan, Arik; Amidon, Gordon L

    2015-01-05

    The purpose of this study was to evaluate minoxidil as a high permeability reference drug for Biopharmaceutics Classification System (BCS). The permeability of minoxidil was determined in in situ intestinal perfusion studies in rodents and permeability studies across Caco-2 cell monolayers. The permeability of minoxidil was compared with that of metoprolol, an FDA reference drug for BCS classification. In rat perfusion studies, the permeability of minoxidil was somewhat higher than that of metoprolol in the jejunum, while minoxidil showed lower permeability than metoprolol in the ileum. The permeability of minoxidil was independent of intestinal segment, while the permeability of metoprolol was region-dependent. Similarly, in mouse perfusion study, the jejunal permeability of minoxidil was 2.5-fold higher than that of metoprolol. Minoxidil and metoprolol showed similar permeability in Caco-2 study at apical pH of 6.5 and basolateral pH of 7.4. The permeability of minoxidil was independent of pH, while metoprolol showed pH-dependent transport in Caco-2 study. Minoxidil exhibited similar permeability in the absorptive direction (AP-BL) in comparison with secretory direction (BL-AP), while metoprolol had higher efflux ratio (ER > 2) at apical pH of 6.5 and basolateral pH of 7.4. No concentration-dependent transport was observed for either minoxidil or metoprolol transport in Caco-2 study. Verapamil did not alter the transport of either compounds across Caco-2 cell monolayers. The permeability of minoxidil was independent of both pH and intestinal segment in intestinal perfusion studies and Caco-2 studies. Caco-2 studies also showed no involvement of carrier mediated transport in the absorption process of minoxidil. These results suggest that minoxidil may be an acceptable reference drug for BCS high permeability classification. However, minoxidil exhibited higher jejunal permeability than metoprolol and thus to use minoxidil as a reference drug would raise the

  5. [Reinventing specialty training of physicians? Principles and challenges].

    Science.gov (United States)

    Morán-Barrios, J; Ruiz de Gauna Bahillo, P

    2010-01-01

    In a world undergoing constant change, in the era of globalisation, the training of medical professionals should be under constant review so that it can be tailored to meet the needs of this society in transition. This is all the more true at times of economic uncertainty, such as the current conditions, which have a direct impact on health services. Professionals need new Competencies for new times. Over the last decade initiatives have emerged in various Anglo-Saxon countries which have defined a framework of basic Competencies that all medical specialists should demonstrate in their professional practice. In addition to this, we must respond to the creation of the European Higher Education Area which has implications for specialised training. In Spain, training for medical specialists was in need of an overhaul and the recently passed law (Real Decreto 183/2008) will allow us to move forward and implement, in medical education, initiatives and innovations required in our medical centres, to respond to the new society and bring us in line with international professional education and practice. The way forward is a Competency-based model for medical education with assessment of these Competencies using simple instruments, validated and accepted by all the stakeholders. The institutions involved (hospitals, medical centres and other health care services) should trial different approaches within the general framework established by the current legislation and be conscious of the duty they have to society as accredited training organisations. Accordingly, they should consolidate their teaching and learning structures and the various different educational roles (Director of Studies, Tutors, and other teaching positions), showing the leadership necessary to allow proper implementation of their training programmes. For this, the Spanish Autonomous Regions must develop their own legislation regulating Medical Specialty Training. So, medical professionals should receive

  6. Specialty choice preference of medical students according to personality traits by Five-Factor Model.

    Science.gov (United States)

    Kwon, Oh Young; Park, So Youn

    2016-03-01

    The purpose of this study was to determine the relationship between personality traits, using the Five-Factor Model, and characteristics and motivational factors affecting specialty choice in Korean medical students. A questionnaire survey of Year 4 medical students (n=110) in July 2015 was administered. We evaluated the personality traits of Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Openness by using the Korean version of Big Five Inventory. Questions about general characteristics, medical specialties most preferred as a career, motivational factors in determining specialty choice were included. Data between five personality traits and general characteristics and motivational factors affecting specialty choice were analyzed using Student t-test, Mann-Whitney test and analysis of variance. Of the 110 eligible medical students, 105 (95.4% response rate) completed the questionnaire. More Agreeableness students preferred clinical medicine to basic medicine (p=0.010) and more Openness students preferred medical departments to others (p=0.031). Personal interest was the significant motivational factors in more Openness students (p=0.003) and Conscientiousness students (p=0.003). Medical students with more Agreeableness were more likely to prefer clinical medicine and those with more Openness preferred medical departments. Personal interest was a significant influential factor determining specialty choice in more Openness and Conscientiousness students. These findings may be helpful to medical educators or career counselors in the specialty choice process.

  7. Physician work intensity among medical specialties: emerging evidence on its magnitude and composition.

    Science.gov (United States)

    Horner, Ronnie D; Szaflarski, Jerzy P; Ying, Jun; Meganathan, Karthikeyan; Matthews, Gerald; Schroer, Brian; Weber, Debra; Raphaelson, Marc

    2011-11-01

    Similarities and differences in physician work intensity among specialties are poorly understood but have implications for quality of care, patient safety, practice organization and management, and payment. To determine the magnitude and important dimensions of physician work intensity for 4 specialties. Cross-sectional assessment of work intensity associated with actual patient care in the examination room or operating room. A convenience sample of 45 family physicians, 20 general internists, 22 neurologists, and 21 surgeons, located in Kansas, Kentucky, Maryland, Ohio, and Virginia. Work intensity measures included the National Aeronautics and Space Administration-Task Load Index (NASA-TLX), Subjective Work Assessment Technique (SWAT), and Multiple Resource Questionnaire. Stress was measured by the Dundee Stress State Questionnaire. Physicians reported similar magnitude of work intensity on the NASA-TLX and Multiple Resource Questionnaire. On the SWAT, general internists reported work intensity similar to surgeons but significantly lower than family physicians and neurologists (P=0.035). Surgeons reported significantly higher levels of task engagement on the stress measure than the other specialties (P=0.019), significantly higher intensity on physical demand (P NASA-TLX than the other specialties (P=0.003). Surgeons reported the lowest intensity for temporal demand of all specialties, being significantly lower than either family physicians or neurologists (P=0.014). Family physicians reported the highest intensity on the time dimension of the SWAT, being significantly higher than either general internists or surgeons (P=0.008). Level of physician work intensity seems to be similar among specialties.

  8. Specialty choice preference of medical students according to personality traits by Five-Factor Model

    Directory of Open Access Journals (Sweden)

    Oh Young Kwon

    2016-03-01

    Full Text Available Purpose: The purpose of this study was to determine the relationship between personality traits, using the Five-Factor Model, and characteristics and motivational factors affecting specialty choice in Korean medical students. Methods: A questionnaire survey of Year 4 medical students (n=110 in July 2015 was administered. We evaluated the personality traits of Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Openness by using the Korean version of Big Five Inventory. Questions about general characteristics, medical specialties most preferred as a career, motivational factors in determining specialty choice were included. Data between five personality traits and general characteristics and motivational factors affecting specialty choice were analyzed using Student t-test, Mann-Whitney test and analysis of variance. Results: Of the 110 eligible medical students, 105 (95.4% response rate completed the questionnaire. More Agreeableness students preferred clinical medicine to basic medicine (p=0.010 and more Openness students preferred medical departments to others (p=0.031. Personal interest was the significant motivational factors in more Openness students (p=0.003 and Conscientiousness students (p=0.003. Conclusion: Medical students with more Agreeableness were more likely to prefer clinical medicine and those with more Openness preferred medical departments. Personal interest was a significant influential factor determining specialty choice in more Openness and Conscientiousness students. These findings may be helpful to medical educators or career counselors in the specialty choice process.

  9. Surgical specialty procedures in rural surgery practices: implications for rural surgery training.

    Science.gov (United States)

    Sticca, Robert P; Mullin, Brady C; Harris, Joel D; Hosford, Clint C

    2012-12-01

    Specialty procedures constitute one eighth of rural surgery practice. Currently, general surgeons intending to practice in rural hospitals may not get adequate training for specialty procedures, which they will be expected to perform. Better definition of these procedures will help guide rural surgery training. Current Procedural Terminology codes for all surgical procedures for 81% of North Dakota and South Dakota rural surgeons were entered into the Dakota Database for Rural Surgery. Specialty procedures were analyzed and compared with the Surgical Council on Resident Education curriculum to determine whether general surgery training is adequate preparation for rural surgery practice. The Dakota Database for Rural Surgery included 46,052 procedures, of which 5,666 (12.3%) were specialty procedures. Highest volume specialty categories included vascular, obstetrics and gynecology, orthopedics, cardiothoracic, urology, and otolaryngology. Common procedures in cardiothoracic and vascular surgery are taught in general surgical residency, while common procedures in obstetrics and gynecology, orthopedics, urology, and otolaryngology are usually not taught in general surgery training. Optimal training for rural surgery practice should include experience in specialty procedures in obstetrics and gynecology, orthopedics, urology, and otolaryngology. Copyright © 2012 Elsevier Inc. All rights reserved.

  10. A reaction limited in vivo dissolution model for the study of drug absorption: Towards a new paradigm for the biopharmaceutic classification of drugs.

    Science.gov (United States)

    Macheras, Panos; Iliadis, Athanassios; Melagraki, Georgia

    2018-05-30

    The aim of this work is to develop a gastrointestinal (GI) drug absorption model based on a reaction limited model of dissolution and consider its impact on the biopharmaceutic classification of drugs. Estimates for the fraction of dose absorbed as a function of dose, solubility, reaction/dissolution rate constant and the stoichiometry of drug-GI fluids reaction/dissolution were derived by numerical solution of the model equations. The undissolved drug dose and the reaction/dissolution rate constant drive the dissolution rate and determine the extent of absorption when high-constant drug permeability throughout the gastrointestinal tract is assumed. Dose is an important element of drug-GI fluids reaction/dissolution while solubility exclusively acts as an upper limit for drug concentrations in the lumen. The 3D plots of fraction of dose absorbed as a function of dose and reaction/dissolution rate constant for highly soluble and low soluble drugs for different "stoichiometries" (0.7, 1.0, 2.0) of the drug-reaction/dissolution with the GI fluids revealed that high extent of absorption was found assuming high drug- reaction/dissolution rate constant and high drug solubility. The model equations were used to simulate in vivo supersaturation and precipitation phenomena. The model developed provides the theoretical basis for the interpretation of the extent of drug's absorption on the basis of the parameters associated with the drug-GI fluids reaction/dissolution. A new paradigm emerges for the biopharmaceutic classification of drugs, namely, a model independent biopharmaceutic classification scheme of four drug categories based on either the fulfillment or not of the current dissolution criteria and the high or low % drug metabolism. Copyright © 2018. Published by Elsevier B.V.

  11. Strategic establishment of an International Pharmacology Specialty Laboratory in a resource-limited setting.

    Science.gov (United States)

    Mtisi, Takudzwa J; Maponga, Charles; Monera-Penduka, Tsitsi G; Mudzviti, Tinashe; Chagwena, Dexter; Makita-Chingombe, Faithful; DiFranchesco, Robin; Morse, Gene D

    2018-01-01

    A growing number of drug development studies that include pharmacokinetic evaluations are conducted in regions lacking a specialised pharmacology laboratory. This necessitated the development of an International Pharmacology Specialty Laboratory (IPSL) in Zimbabwe. The aim of this article is to describe the development of an IPSL in Zimbabwe. The IPSL was developed collaboratively by the University of Zimbabwe and the University at Buffalo Center for Integrated Global Biomedical Sciences. Key stages included infrastructure development, establishment of quality management systems and collaborative mentorship in clinical pharmacology study design and chromatographic assay development and validation. Two high performance liquid chromatography instruments were donated by an instrument manufacturer and a contract research organisation. Laboratory space was acquired through association with the Zimbabwe national drug regulatory authority. Operational policies, standard operating procedures and a document control system were established. Scientists and technicians were trained in aspects relevant to IPSL operations. A high-performance liquid chromatography method for nevirapine was developed with the guidance of the Clinical Pharmacology Quality Assurance programme and approved by the assay method review programme. The University of Zimbabwe IPSL is engaged with the United States National Institute of Allergy and Infectious Diseases Division of AIDS research networks and is poised to begin drug assays and pharmacokinetic analyses. An IPSL has been successfully established in a resource-limited setting through the efforts of an external partnership providing technical guidance and motivated internal faculty and staff. Strategic partnerships were beneficial in navigating challenges leading to laboratory development and training new investigators. The IPSL is now engaged in clinical pharmacology research.

  12. Gender differences in specialty preference and mismatch with real needs in Japanese medical students

    Directory of Open Access Journals (Sweden)

    Harada Tadanari

    2010-02-01

    Full Text Available Abstract Background The shortage of doctors and maldistribution among specialties are of great concern in the Japanese health care system. This study investigated specialty preference in medical students of one university, and examined gender differences and compared their preference with real needs. Methods We conducted a self-administered questionnaire including specialty preference in all students of one medical university. Preference was assessed by the five-level probability of their future choice: 1 = very low, 2 = low, 3 = moderate, 4 = high, and 5 = very high. The proportion of 4 or 5 was calculated as the preference rate. The real needs (magnitude of doctor shortage in the prefecture were drawn from two different surveys. The relationship between the sex-specific preference rate by specialty and real needs was assessed by Spearman's correlation coefficient. Results Internal medicine showed the highest preference rate, followed by general surgery, pediatrics, and emergency medicine. There was no significant correlation between the preference rates of men and women (r = 0.27, p = 0.34. The preference rates for general surgery, orthopedics, neurosurgery, and emergency medicine were significantly higher in men than in women, while those of obstetrics & gynecology, pediatrics, and dermatology were significantly higher in women. The magnitude of doctor shortage by specialty from two surveys were significantly correlated with the total preference rate and men's preference rate (r = 0.54 to 0.74, but not with women's preference rate (r = 0.06 and 0.32. Conclusions This study elucidated not only gender differences in specialty preference but also the relationship to real needs. Critical gender differences and mismatch with real needs were found in women. In addition to traditional gender roles and insufficient support for women's participation in Japan, gender differences and mismatch influence the current and future maldistribution of

  13. Care coordination and unmet specialty care among children with special health care needs.

    Science.gov (United States)

    Boudreau, Alexy Arauz; Perrin, James M; Goodman, Elizabeth; Kurowski, Daniel; Cooley, W Carl; Kuhlthau, Karen

    2014-06-01

    Care coordination and the medical home may ensure access to specialty care. Children with special health care needs (CSHCN) have higher rates of specialty care use and unmet need compared with the general pediatric population. We hypothesized that care coordination, regardless of whether it was provided in a medical home, would decrease unmet specialty care needs among CSHCN and that the effect of care coordination would be greater among low-income families. Secondary data analysis of participants in the 2009–2010 National Survey of CSHCN who reported unmet specialty care needs and for whom care coordination and medical home status could be determined (n = 18 905). Logistic regression models explored the association of unmet need with care coordination and medical home status adjusting for household income. Approximately 9% of CSHCN reported having unmet specialty care needs. Care coordination was associated with reduced odds of unmet specialty care need (without a medical home, odds ratio: 0.63, 95% confidence interval: 0.47–0.86; within a medical home, odds ratio: 0.22, 95% confidence interval: 0.16–0.29) with a greater reduction among those receiving care coordination within a medical home versus those receiving care coordination without a medical home. We did not find differences in the impact of care coordination by percentage of the federal poverty level. Care coordination is associated with family report of decreased unmet specialty care needs among CSHCN independent of household income. The effect of care coordination is greater when care is received in a medical home.

  14. Analysis, biomedicine, collaboration, and determinism challenges and guidance: wish list for biopharmaceuticals on the interface of computing and statistics.

    Science.gov (United States)

    Goodman, Arnold F

    2011-11-01

    I have personally witnessed processing advance from desk calculators and mainframes, through timesharing and PCs, to supercomputers and cloud computing. I have also witnessed resources grow from too little data into almost too much data, and from theory dominating data into data beginning to dominate theory while needing new theory. Finally, I have witnessed problems advance from simple in a lone discipline into becoming almost too complex in multiple disciplines, as well as approaches evolve from analysis driving solutions into solutions by data mining beginning to drive the analysis itself. How we do all of this has transitioned from competition overcoming collaboration into collaboration starting to overcome competition, as well as what is done being more important than how it is done has transitioned into how it is done becoming as important as what is done. In addition, what or how we do it being more important than what or how we should actually do it has shifted into what or how we should do it becoming just as important as what or how we do it, if not more so. Although we have come a long way in both our methodology and technology, are they sufficient for our current or future complex and multidisciplinary problems with their massive databases? Since the apparent answer is not a resounding yes, we are presented with tremendous challenges and opportunities. This personal perspective adapts my background and experience to be appropriate for biopharmaceuticals. In these times of exploding change, informed perspectives on what challenges should be explored with accompanying guidance may be even more valuable than the far more typical literature reviews in conferences and journals of what has already been accomplished without challenges or guidance. Would we believe that an architect who designs a skyscraper determines the skyscraper's exact exterior, interior and furnishings or only general characteristics? Why not increase dependability of conclusions in

  15. Multivariate statistical monitoring as applied to clean-in-place (CIP) and steam-in-place (SIP) operations in biopharmaceutical manufacturing.

    Science.gov (United States)

    Roy, Kevin; Undey, Cenk; Mistretta, Thomas; Naugle, Gregory; Sodhi, Manbir

    2014-01-01

    Multivariate statistical process monitoring (MSPM) is becoming increasingly utilized to further enhance process monitoring in the biopharmaceutical industry. MSPM can play a critical role when there are many measurements and these measurements are highly correlated, as is typical for many biopharmaceutical operations. Specifically, for processes such as cleaning-in-place (CIP) and steaming-in-place (SIP, also known as sterilization-in-place), control systems typically oversee the execution of the cycles, and verification of the outcome is based on offline assays. These offline assays add to delays and corrective actions may require additional setup times. Moreover, this conventional approach does not take interactive effects of process variables into account and cycle optimization opportunities as well as salient trends in the process may be missed. Therefore, more proactive and holistic online continued verification approaches are desirable. This article demonstrates the application of real-time MSPM to processes such as CIP and SIP with industrial examples. The proposed approach has significant potential for facilitating enhanced continuous verification, improved process understanding, abnormal situation detection, and predictive monitoring, as applied to CIP and SIP operations. © 2014 American Institute of Chemical Engineers.

  16. On-line coupling of size exclusion chromatography with mixed-mode liquid chromatography for comprehensive profiling of biopharmaceutical drug product.

    Science.gov (United States)

    He, Yan; Friese, Olga V; Schlittler, Michele R; Wang, Qian; Yang, Xun; Bass, Laura A; Jones, Michael T

    2012-11-02

    A methodology based on on-line coupling of size exclusion chromatography (SEC) with mixed-mode liquid chromatography (LC) has been developed. The method allows for simultaneous measurement of a wide range of components in biopharmaceutical drug products. These components include the active pharmaceutical ingredient (protein) and various kinds of excipients such as cations, anions, nonionic hydrophobic surfactant and hydrophilic sugars. Dual short SEC columns are used to separate small molecule excipients from large protein molecules. The separated protein is quantified using a UV detector at 280 nm. The isolated excipients are switched, online, to the Trinity P1 mixed-mode column for separation, and detected by an evaporative light scattering detector (ELSD). Using a stationary phase with 1.7 μm particles in SEC allows for the use of volatile buffers for both SEC and mix-mode separation. This facilitates the detection of different excipients by ELSD and provides potential for online characterization of the protein with mass spectrometry (MS). The method has been applied to quantitate protein and excipients in different biopharmaceutical drug products including monoclonal antibodies (mAb), antibody drug conjugates (ADC) and vaccines. Copyright © 2012 Elsevier B.V. All rights reserved.

  17. Evaluation of spectral libraries and sample preparation for DIA-LC-MS analysis of host cell proteins: A case study of a bacterially expressed recombinant biopharmaceutical protein.

    Science.gov (United States)

    Heissel, Søren; Bunkenborg, Jakob; Kristiansen, Max Per; Holmbjerg, Anne Fich; Grimstrup, Marie; Mørtz, Ejvind; Kofoed, Thomas; Højrup, Peter

    2018-07-01

    Recombinantly expressed biopharmaceutical proteins often undergo a series of purification steps with the aim of removing contaminating material. Depending on the application of the protein, there are various requirements for the degree of purity, but host cell proteins (HCPs) will in general remain in small amounts. LC-MS has emerged as an orthogonal technique, capable of providing detailed information regarding the individual proteins. The aim of this case study was to characterize the HCPs associated with a biopharmaceutical protein, provided by Statens Serum Institut (DK), which is used in the field of tuberculosis and has not previously been studied by LC-MS. The developed method and acquired experiences served to develop a generalized strategy for HCP-characterization in our laboratory. We evaluated the use of different spectral libraries, recorded in data-dependent mode for obtaining the highest HCP coverage, combined with SWATH-based absolute quantification. The accuracy of two label-free absolute quantification strategies was evaluated using stable isotope peptides. Two different sample preparation workflows were evaluated for optimal HCP yield. . The label-free strategy produced accurate quantification across several orders of magnitude, and the calculated purity was found to be in agreement with previously obtained ELISA data. Copyright © 2018 Elsevier Inc. All rights reserved.

  18. Questionnaire survey on the process of specialty training in neurology in Japan.

    Science.gov (United States)

    Sonoo, Masahiro; Nishiyama, Kazutoshi; Ando, Tetsuo; Shindo, Katsuro; Kanda, Takashi; Aoki, Masashi; Kamei, Satoshi; Kikuchi, Seiji; Kusunoki, Susumu; Suzuki, Norihiro; Sobue, Gen; Nakashima, Kenji; Hara, Hideo; Hirata, Koichi; Mizusawa, Hidehiro; Murai, Hiroyuki; Murata, Miho; Mochizuki, Hideki; Takahashi, Ryosuke; Kira, Jun-Ichi

    2017-07-29

    Documentation of the current status of specialty training to become a neurologist in Japan would represent an important basis for constructing better neurology training program in the planned reform of the specialty training system in Japan. The committee for future neurology specialty system of Japanese Society of Neurology (JSN) conducted a questionnaire survey on the process of specialty training of each trainee for neurology in board-certified educational facilities and semi-educational facilities throughout Japan. The response rate was 46.2% in all facilities and 87.5% in medical universities. The training process of 905 trainees over 5 grades was clarified, which was estimated to be about 80% of all the relevant subjects. Specialty training dedicated to neurology was started at the 3rd year of residency in 87.8% of subjects. During the 3 years following junior residency, 51.3% of subjects ran the rotation training between university and city hospital, whereas 36.5% was trained within the same institution throughout the 3 years of training period.

  19. Choosing a career in paediatrics: do trainees' views change over the first year of specialty training?

    Science.gov (United States)

    Goodyear, Helen M; Lakshminarayana, Indumathy; Wall, David; Bindal, Taruna

    2014-09-01

    To look at why a regional cohort of UK doctors chose a paediatric career and to ascertain views on their career near the end of training year one. A 20-item questionnaire was sent to all new regional paediatric specialty trainees. Three focus groups were held with trainees near the end of year one to elicit key themes. West Midlands Deanery, UK. Twenty-nine new regional paediatric specialty trainees in year one completed the questionnaire. A total of 15 trainees participated in the focus groups near the end of year one training. Reasons for choosing a paediatric career and factors which further influence career choice for trainees during their first specialty training year. Key influencing factors for choosing paediatrics were enjoying working with children and positive undergraduate experience of the specialty. All trainees had paediatrics as their first choice specialty and undertook a paediatric Foundation post. Near the end of year one, doubts were cast on career aspirations due to seeing middle grade colleagues struggling with work-life balance and a growing feeling that family came first. Senior trainees need to be aware that they act as powerful role models for their more junior colleagues and therefore have an influential role on how juniors perceive a paediatric career. Family friendly flexible working patterns in paediatrics are vital to retain junior trainees. All paediatric staff are role models and need to be enthusiastic, keen to teach and to promote a positive working environment.

  20. Specialty preferences and motivating factors: A national survey on medical students from five uae medical schools.

    Science.gov (United States)

    Abdulrahman, Mahera; Makki, Maryam; Shaaban, Sami; Al Shamsi, Maryam; Venkatramana, Manda; Sulaiman, Nabil; Sami, Manal M; Abdelmannan, Dima K; Salih, AbdulJabbar M A; AlShaer, Laila

    2016-01-01

    Workforce planning is critical for being able to deliver appropriate health service and thus is relevant to medical education. It is, therefore, important to understand medical students' future specialty choices and the factors that influence them. This study was conducted to identify, explore, and analyze the factors influencing specialty preferences among medical students of the United Arab Emirates (UAE). A multiyear, multicenter survey of medical student career choice was conducted with all five UAE medical schools. The questionnaire consisted of five sections. Chi-squared tests, regression analysis, and stepwise logistic regression were performed. The overall response rate was 46% (956/2079). Factors that students reported to be extremely important when considering their future career preferences were intellectual satisfaction (87%), work-life balance (71%), having the required talent (70%), and having a stable and secure future (69%). The majority of students (60%) preferred internal medicine, surgery, emergency medicine, or family Medicine. The most common reason given for choosing a particular specialty was personal interest (21%), followed by flexibility of working hours (17%). The data show that a variety of factors inspires medical students in the UAE in their choice of a future medical specialty. These factors can be used by health policymakers, university mentors, and directors of residency training programs to motivate students to choose specialties that are scarce in the UAE and therefore better serve the health-care system and the national community.

  1. Preparation for a postgraduate specialty examination by medical students in Turkey: processes and sources of anxiety.

    Science.gov (United States)

    Turan, Sevgi; Üner, Sarp

    2015-01-01

    PHENOMENON: Interns in Turkey must endeavor to study for a specialty exam during their internship. The preparation process for the specialty exam and the effect of this process on the students' anxiety has not been studied comprehensively. The purpose of this study was to evaluate the interns' preparation time for the specialty exam, their perception of how the preparation process affects their training, and which factors are related to their test anxiety. A cross-sectional study was conducted with 6th-year students (interns). A questionnaire asked participants to report health status, academic achievement, exam-related anxiety, and trait anxiety. Two open-ended questions asked about views regarding the specialty exam. Multiple linear regression was used to identify the significant predictors of anxiety level due to the exam. The average duration of exam preparations of participating interns (n = 214) was 16.8 months and 14.3 hours/week. Participating interns' health status, economic level, perception of academic achievement, time allocated to study for the exam, time remaining until the exam, and trait anxiety level demonstrated a relationship with anxiety level due to the exam (R =.35, R(2) =.13, p anxiety level. The internship curriculum, requirements, and timing of the specialty exam should be reconsidered.

  2. Much ado about nothing? The financial impact of physician-owned specialty hospitals.

    Science.gov (United States)

    Chakravarty, Sujoy

    2016-06-01

    The U.S. hospital industry has recently witnessed a number of policy changes aimed at aligning hospital payments to costs and these can be traced to significant concerns regarding selection of profitable patients and procedures by physician-owned specialty hospitals. The policy responses to specialty hospitals have alternated between payment system reforms and outright moratoriums on hospital operations including one in the recently enacted Affordable Care Act. A key issue is whether physician-owned specialty hospitals pose financial strain on the larger group of general hospitals through cream-skimming of profitable patients, yet there is no study that conducts a systematic analysis relating such selection behavior by physician-owners to financial impacts within hospital markets. The current paper takes into account heterogeneity in specialty hospital behavior and finds some evidence of their adverse impact on profit margins of competitor hospitals, especially for-profit hospitals. There is also some evidence of hospital consolidation in response to competitive pressures by specialty hospitals. Overall, these findings underline the importance of the payment reforms aimed at correcting distortions in the reimbursement system that generate incentives for risk-selection among providers groups. The identification techniques will also inform empirical analysis on future data testing the efficacy of these payment reforms.

  3. Advanced specialty fiber designs for high power fiber lasers

    Science.gov (United States)

    Gu, Guancheng

    The output power of fiber lasers has increased rapidly over the last decade. There are two major limiting factors, namely nonlinear effects and transverse mode instability, prohibiting the power scaling capability of fiber lasers. The nonlinear effects, originating from high optical intensity, primarily limit the peak power scaling. The mode instability, on the other hand, arises from quantum-defect driven heating, causing undesired mode coupling once the power exceeds the threshold and degradation of beam quality. The mode instability has now become the bottleneck for average output power scaling of fiber lasers. Mode area scaling is the most effective way to mitigate nonlinear effects. However, the use of large mode area may increase the tendency to support multiple modes in the core, resulting in lower mode instability threshold. Therefore, it is critical to maintain single mode operation in a large mode area fiber. Sufficient higher order mode suppression can lead to effective single-transverse-mode propagation. In this dissertation, we explore the feasibility of using specialty fiber to construct high power fiber lasers with robust single-mode output. The first type of fiber discussed is the resonantly-enhanced leakage channel fiber. Coherent reflection at the fiber outer boundary can lead to additional confinement especially for highly leaky HOM, leading to lower HOM losses than what are predicted by conventional finite element mothod mode solver considering infinite cladding. In this work, we conducted careful measurements of HOM losses in two leakage channel fibers (LCF) with circular and rounded hexagonal boundary shapes respectively. Impact on HOM losses from coiling, fiber boundary shapes and coating indexes were studied in comparison to simulations. This work demonstrates the limit of the simulation method commonly used in the large-mode-area fiber designs and the need for an improved approach. More importantly, this work also demonstrates that a

  4. Biosimilars--global issues, national solutions.

    Science.gov (United States)

    Knezevic, Ivana; Griffiths, Elwyn

    2011-09-01

    Biotechnology derived medicinal products are presently the best characterized biologicals with considerable production and clinical experience, and have revolutionized the treatment of some of the most difficult-to-treat diseases, prolonging and improving the quality of life and patient care. They are also currently one of the fastest growing segments of the pharmaceutical industry market. The critical challenge that the biopharmaceutical industry is facing is the expiry of patents for the first generation of biopharmaceuticals, mainly recombinant DNA derived products, such as interferons, growth hormone and erythropoetin. The question that immediately arose was how should such copies of the originator products be licensed, bearing in mind that they are highly complex biological molecules produced by equally complex biological production processes with their inherent problem of biological variability. Copying biologicals is much more complex than copying small molecules and the critical issue was how to handle the licensing of products if relying in part on data from an innovator product. Since 2004 there has been considerable international consultation on how to deal with biosimilars and biological copy products. This has led to a better understanding of the challenges in the regulatory evaluation of the quality, safety and efficacy of "biosimilars", to the exchange of information between regulators, as well as to the identification of key issues. The aim of this article is to provide a brief overview of the scientific and regulatory challenges faced in developing and evaluating similar biotherapeutic products for global use. It is intended as an introduction to the series of articles in this special issue of Biologicals devoted to similar biotherapeutic products. Copyright © 2011. Published by Elsevier Ltd.

  5. The microbiological safety of ready-to-eat specialty meats from markets and specialty food shops: a UK wide study with a focus on Salmonella and Listeria monocytogenes.

    Science.gov (United States)

    Gormley, F J; Little, C L; Grant, K A; de Pinna, E; McLauchlin, J

    2010-04-01

    From 2359 specialty meats (continental sausages, cured/fermented, dried meats) sampled from markets and specialty food shops, 98.9% of samples were of satisfactory or acceptable microbiological quality. However, 16 (0.7%) were unsatisfactory as a result of Escherichia coli, Staphylococcus aureus or Listeria spp. contamination (>or=10(2) CFU/g), and nine (0.4%) were unacceptable due to presence of Salmonella spp. or Listeria monocytogenes (>10(2) CFU/g). Meats with unacceptable levels of L. monocytogenes were within shelf life (range: 8-143 days remaining). Nine different subtypes of L. monocytogenes were detected with sero/AFLP type 1/2c VII predominating (37%), although this subtype was not overrepresented in any particular meat type (P > 0.05). Ninety-six percent of continental sausages and cured/fermented products were stored at potential for L. monocytogenes to be present at levels hazardous to health at the point of sale.

  6. BIOCHEMISTRY IN THE SPECIALTY IN VISUAL FUNCTION, AND VIRTUAL ENVIRONMENTS IN THE CICS UMA-IPN

    Directory of Open Access Journals (Sweden)

    Blanca Elisa Pérez-Magaña

    2014-07-01

    Full Text Available The higher education and postgraduate in Mexico." delivered at the National Polytechnic Institute is located in a period of constant modification and sustained that has led to the creation of new pedagogical proposals aimed at the promotion of learning emphasizing virtual education. The development of ICT (Information Technologies and Communication in the last few years has favored the emergence and consolidation of degrees, diplomas, Specialties, Master's Degrees among other, using the distance learning based on a web environment. This work analyzes the importance that had the Biochemistry course taught in the specialty of Visual Function in the CICS and UMA that allowed both to the students as the teachers try to virtually eliminate the disadvantages theoretical to traditional teaching. The results obtained in addition to the skills and competences acquired the students were highly successful, and it is hoped to be able to continue implementing such environments in other specialties and master's degrees.

  7. Lessons Learned in Pilot Testing Specialty Consultations to Benefit Individuals with Lower Limb Loss

    Directory of Open Access Journals (Sweden)

    Christine Elnitsky

    2012-12-01

    Full Text Available Telerehabilitation technologies enable the delivery of rehabilitation services from providers to people with disabilities as well as specialty care consultations. This article discusses the barriers experienced when planning and pilot testing a telerehabilitation multi-site specialty consultation for specialists in their medical centers, and the lessons learned. The barriers included integration and participation, coordination across organizational units, and privacy and information security. Lessons learned included the need for collaboration across multiple departments, telerehabilitation equipment back-ups, and anonymous and private communication protocols. Despite delays resulting from coordination at multiple levels of a national organization, we developed a program plan and successfully implemented a pilot test of the southeast region program.  Specialty consultation using telerehabilitation delivery methods requires identifying provider preferences for technological features. Lessons learned could inform development of outpatient telerehabilitation for patients with amputations and studies of patients and providers involved in telerehabilitation.

  8. Global climate change: a framework for nursing action

    Directory of Open Access Journals (Sweden)

    GAVIN J. ANDREWS

    2009-01-01

    Full Text Available Recent research papers and commentaries have articulated the considerable effects that global climate change has had, and will have, on human health. Arguing that nursing must become more centrally involved in mitigation and response efforts, this paper develops a framework for professional consideration and action. Four core components of the framework are common tactics, maximizing specialties, prioritizing places and public scholarship.

  9. Does a single specialty intensive care unit make better business sense than a multi-specialty intensive care unit? A costing study in a trauma center in India.

    Science.gov (United States)

    Kumar, Parmeshwar; Jithesh, Vishwanathan; Gupta, Shakti Kumar

    2015-01-01

    Though intensive care units (ICUs) only account for 10% of hospital beds, they consume nearly 22% of hospital resources. Few definitive costing studies have been conducted in Indian settings that would help determine appropriate resource allocation. To evaluate and compare the cost of intensive care delivery between multi-specialty and neurosurgery ICU in an apex trauma care facility in India. The study was conducted in a polytrauma and neurosurgery ICU at a 203 bedded level IV trauma care facility in New Delhi, India from May, 2012 to June 2012. The study was cross-sectional, retrospective, and record-based. Traditional costing was used to arrive at the cost for both direct and indirect cost estimates. The cost centers included in study were building cost, equipment cost, human resources, materials and supplies, clinical and nonclinical support services, engineering maintenance cost, and biomedical waste management. Fisher's two-tailed t-test. Total cost/bed/day for the multi-specialty ICU was Rs. 14,976.9/- and for the neurosurgery ICU was Rs. 14,306.7/-, manpower constituting nearly half of the expenditure in both ICUs. The cost center wise and overall difference in the cost among the ICUs were statistically significant. Quantification of expenditure in running an ICU in a trauma center would assist healthcare decision makers in better allocation of resources. Although multi-specialty ICUs are more expensive, other factors will also play a role in defining the kind of ICU that need to be designed.

  10. Perception of 1 st year medical students towards career choices and specialty of psychiatry

    Directory of Open Access Journals (Sweden)

    Suneet Kumar Upadhyaya

    2015-01-01

    Full Text Available Background: Shortage of psychiatrists is a worldwide phenomenon. If the factors that attract or repel students towards a specialty can be identified, it may be possible to encourage them towards it. Choice of specialty as a career depends on the complex interplay of experiences before, during or after exposure to the specialty. Objectives: The aim was to understand perceptions of 1 st year medical students regarding career choices and the specialty of psychiatry through a cross-sectional questionnaire-based study. Materials and Methods: Perceptions of 137 1 st year medical students from the Government Medical College were recorded using a semi-structured questionnaire. Students provided their opinions about future career choices; perspective of these specialties in terms of financial reward, reputation, work-life balance, challenging aspect, ability to help patients effectively and emotional stability; their preferences in life and interaction with psychiatrist and its impact. Statistical Analysis Used: One-way analysis of variance (ANOVA with post-hoc analysis by Tukey-Kramer test. Results: Surgery was a high priority for 69 (50% while psychiatry was a high priority only for 11 (8%. Surgery was highest for financial reward and reputation, but lowest for work-life balance. Psychiatry had higher emotional stability, however, its the reputation was lower than surgery, medicine, obstetrics and gynaecology and paediatrics. Students preferred reputation (41% over social service opportunities (43%, work-life balance (16%, and high-income (11%. Interaction with psychiatrist increased inclination for psychiatry in 69% (9/13 students. Conclusions: Psychiatry is not a preferred specialty among 1 st year medical students due to its poor reputation.

  11. International Medical Graduates in Radiation Oncology: Historical Trends and Comparison With Other Medical Specialties

    Energy Technology Data Exchange (ETDEWEB)

    Verma, Vivek, E-mail: vivek333@gmail.com [Department of Radiation Oncology, University of Nebraska Medical Center, Omaha, Nebraska (United States); Shah, Chirag [Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio (United States); Lautenschlaeger, Tim [Department of Radiation Oncology, Indiana University School of Medicine, Indianapolis, Indiana (United States); Lin, Chi [Department of Radiation Oncology, University of Nebraska Medical Center, Omaha, Nebraska (United States); Beriwal, Sushil [Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (United States); Zhen, Weining [Department of Radiation Oncology, University of Nebraska Medical Center, Omaha, Nebraska (United States); Mehta, Minesh P. [Department of Radiation Oncology, Miami Cancer Institute, Coral Gables, Florida (United States); Zietman, Anthony L. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States)

    2016-07-15

    Purpose: This is the first National Resident Matching Program analysis evaluating historical patterns of international medical graduates (IMGs) in radiation oncology (RO) and providing comparison with American (MD) medical graduates (AMGs), osteopathic students (DOs), unfilled positions, and other specialties. Methods and Materials: National Resident Matching Program data for IMGs were available from 2003 to 2015, with limited data for other specialty matches. The following RO-specific figures were obtained per year: total positions available; total matched positions; number of unfilled positions; and number of IMG, AMG, and DO matches. In addition, the number of IMG matches and total matched positions were obtained for 19 other specialties. Fisher exact tests and χ{sup 2} tests were considered significant at α <.05. Results: From 2010 to 2015, 0.8% of RO matches were IMGs, a decline from 2.4% in 2003 to 2009 (P=.006). Proportions of DO matches during these intervals increased by 40% (from 1.0% to 1.4%), significantly lower than IMGs for 2003 to 2009 (P=.03) but not 2010 to 2015 (P=.26). From 2003 to 2015, the percentage of IMG matches, at 1.5%, was significantly lower than the percentage of unfilled seats, at 3.5% (P<.001). In comparison with other specialties (2003-2015), RO had the fewest IMG matches (1.5%), followed by otolaryngology (1.9%) and orthopedics (2.2%); specialties with the highest IMG proportions were internal medicine (37.1%), family medicine (35.7%), and neurology (31.1%). Conclusions: Presently, IMGs represent <1% of RO matches, the lowest among major specialties. There are several speculative factors associated with this low proportion. There are significantly more unfilled positions than those filled by IMGs; programs at risk of not matching could weigh the advantages and disadvantages of interviewing IMGs.

  12. Does Specialty Bias Trump Evidence in the Management of High-risk Prostate Cancer?

    Science.gov (United States)

    Kishan, Amar U; Duchesne, Gillian; Wang, Pin-Chieh; Rwigema, Jean-Claude M; Saigal, Christopher; Rettig, Matthew; Steinberg, Michael L; King, Christopher R

    2018-06-01

    The objective was to query how specialty influences treatment recommendations for high-risk prostate cancer in 3 clinical settings: upfront management, postoperative management, and management of biochemical recurrences (BCRs) after radiotherapy (RT). We hypothesized that specialty bias would manifest in all settings, trumping available evidence. A survey of practicing urologists and radiation oncologists was distributed through electronic mail. Questions pertained to upfront management, postoperative treatment, and local salvage for postradiation BCRs. The associations between 26 selected categorical responses and specialty were assessed using multivariate logistic regression. Training level/expertise, practice setting, percentage of consultation caseload consisting of prostate cancer, and nationality were set as effect modifiers. One thousand two hundred fifty-three physicians (846 radiation oncologists and 407 urologists) completed the survey. Radiation oncologists were more likely to recommend adjuvant RT and consider it to be underutilized, and more likely to recommend salvage RT at lower prostate-specific antigen thresholds (P<0.0001). Urologists were more likely to recommend salvage radical prostatectomy or cryoablation for local salvage after RT, whereas radiation oncologists were more likely to recommend RT-based modalities and more likely to report that local salvage was underutilized after RT (P<0.0001). Urologists were more likely to report that upfront radical prostatectomy was a better definitive treatment (P<0.0001), whereas radiation oncologists were more likely to report the opposite (P=0.005). Specialty biases permeate recommendations for upfront management and management in the postoperative and post-RT BCR setting, irrespective of available evidence. These data reveal the critical need for multidisciplinary clinics and cross-specialty training as potential solutions for overcoming specialty bias.

  13. Comparison of Women in Department Leadership in Obstetrics and Gynecology With Those in Other Specialties.

    Science.gov (United States)

    Hofler, Lisa G; Hacker, Michele R; Dodge, Laura E; Schutzberg, Rose; Ricciotti, Hope A

    2016-03-01

    To compare the representation of women in obstetrics and gynecology department-based leadership to other clinical specialties while accounting for proportions of women in historical residency cohorts. This was a cross-sectional observational study. The gender of department-based leaders (chair, vice chair, division director) and residency program directors was determined from websites of 950 academic departments of anesthesiology, diagnostic radiology, general surgery, internal medicine, neurology, obstetrics and gynecology, pathology, pediatrics, and psychiatry. Each specialty's representation ratio-proportion of leadership roles held by women in 2013 divided by proportion of residents in 1990 who were women-and 95% confidence interval (CI) were calculated. A ratio of 1 indicates proportionate representation. Women were significantly underrepresented among chairs for all specialties (ratios 0.60 or less, P≤.02) and division directors for all specialties except anesthesiology (ratio 1.13, 95% CI 0.87-1.46) and diagnostic radiology (ratio 0.97, 95% CI 0.81-1.16). The representation ratio for vice chair was below 1.0 for all specialties except anesthesiology; this finding reached statistical significance only for pathology, pediatrics, and psychiatry. Women were significantly overrepresented as residency program directors in general surgery, anesthesiology, obstetrics and gynecology, and pediatrics (ratios greater than 1.19, P≤.046). Obstetrics and gynecology and pediatrics had the highest proportions of residents in 1990 and department leaders in 2013 who were women. Despite having the largest proportion of leaders who were women, representation ratios demonstrate obstetrics and gynecology is behind other specialties in progression of women to departmental leadership. Women's overrepresentation as residency program directors raises concern because education-based academic tracks may not lead to major leadership roles.

  14. Roadmap for a Smart Factory: A Modular, Intelligent Concept for the Production of Specialty Chemicals.

    Science.gov (United States)

    Reitze, Arnulf; Jürgensmeyer, Nikolas; Lier, Stefan; Kohnke, Marco; Riese, Julia; Grünewald, Marcus

    2018-04-09

    Digitalization and increasing the flexibility of production concepts offer the possibility to react to market challenges in the field of specialty chemicals. Shorter product lifetimes, increasing product individualization, and the resulting market volatility impose new requirements on plant operators. Novel concepts such as modular production plants and developments in digitalization (Industry 4.0) are able to assist the implementation of smart factories in specialty chemicals. These essential concepts will be presented in this Minireview. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

  15. Urology – a specialty that will be faced by all future doctors

    Directory of Open Access Journals (Sweden)

    Miah S

    2016-01-01

    Full Text Available Saiful Miah,1 Karl H Pang2 1Department of Urology, Royal Hallamshire Hospital, 2Academic Urology Unit, School of Medicine and Biomedical Sciences at the University of Sheffield, Sheffield, UKWe read with great interest the articles by Shah, and Ah-kee and Khan regarding the various potential methods that could increase the exposure of undergraduate medical students to smaller specialties.1,2 We would like to draw attention to a small but high clinical volume specialty, ie, urology.Read the original article by ShahRead the original article by Ah-kee and Khan 

  16. Experience with DICOM for the clinical specialties in the healthcare enterprise

    Science.gov (United States)

    Kuzmak, Peter M.; Dayhoff, Ruth E.

    2003-05-01

    DICOM is a success for radiology and cardiology and it is now beginning to be used for other clinical specialties. The US Department of Veterans Affairs has been instrumental in promoting this technological advancement. We have worked with a number of non-radiology imaging vendors over the past several years, encouraging them to support DICOM, providing requirement specifications, validating their implementations, installing their products, and integrating their systems with the VA healthcare enterprise. We require each new non-radiology vendor to support the DICOM Modality Worklist and Storage services, as specified in the IHE Technical Framework, and insist that they perform validation testing with us over the Internet before installing at a VA site. Three years ago we began working with commercial DICOM image acquisition applications in ophthalmology and endoscopy. Today we are interfacing with six vendors in ophthalmology, six in dental, and two in endoscopy. Getting imaging modality vendors to support DICOM is only part of the story, however. We have also developed the capabilities of the VistA hospital information system to properly handle DICOM interfaces to the different clinical specialties. The workflow in the clinical specialties is different than that of radiology, and is much more diverse. We designed the VistA DICOM image acquisition and display interface to use the generic order entry, result entry, result reporting, and appointment scheduling applications of our hospital information system, which are common to other hospital information systems, in order to maintain existing clinical workflow, minimize operational disruptions, simplify training, and win user acceptance. This software is now being field tested with dental and ophthalmology systems at a large number of VA medical centers. We have learned several things from this field test. The DICOM Modality Worklist and Storage services can be successfully used for image acquisition in the clinical

  17. Medical Specialty Choice and Related Factors of Brazilian Medical Students and Recent Doctors.

    Directory of Open Access Journals (Sweden)

    Ligia Correia Lima de Souza

    Full Text Available Choosing a medical specialty is an important, complex, and not fully understood process. The present study investigated the factors that are related to choosing and rejecting medical specialties in a group of students and recent medical doctors.A cross-sectional survey of 1,223 medical students and doctors was performed in Brazil in 2012. A standardized literature-based questionnaire was applied that gathered preferable or rejected specialties, and asked questions about extracurricular experiences and the influence of 14 factors on a Likert-type scale from 0 to 4. Specialties were grouped according to lifestyle categories: controllable and uncontrollable, which were subdivided into primary care, internal medicine, and surgical specialties. Notably, the time period of rejection was usually earlier than the time period of intended choice (p < 0.0001, χ(2 = 107.2. The choice mainly occurred during the internship period in medical school (n = 466; 38.7%. An overall large frequency of participation in extracurricular activities was observed (n = 1,184; 95.8%, which were highly associated with the respective medical area. Orthopedic surgery had the highest correlation with participation in specialty-specific organized groups (OR = 59.9, 95% CI = 21.6-166.3 and psychiatry was correlated with participation in research groups (OR = 18.0, 95% CI = 9.0-36.2. With regard to influential factors in controllable lifestyle specialties, "financial reason" (mean score ± standard deviation: 2.8 ± 1.0; median = 3 and "personal time" (3.1 ± 1.3; median = 4 were important factors. In primary care, these factors were less important (1.7 ± 1.3 and 1.7 ± 1.5, respectively; median = 2 for both, and higher scores were observed for "curricular internship" (3.2 ± 1.1, median = 4 and "social commitment" (2.6 ± 1.3, median = 3.The present findings provide important insights into developing strategies to stimulate interest in specialties based on the needs of the

  18. [A scintillating specialty. Excerpts from the history of nuclear medicine in Denmark].

    Science.gov (United States)

    Hess, Søren

    2010-01-01

    Nuclear medicine is among the youngest medical specialties but its history spans more than a century. From the earliest discoveries of radioactivity and the establishment of the novel field of nuclear physics at the turn of the twentieth century and via the developments in radiochemistry set in motion by George de Hevesy from his base in Copenhagen to the specialty of today offering a multitude of diagnostic procedures. The present work is not intended to cover the entire history of nuclear medicine exhaustively but focus on pivotal events in the development of the field with special reference to Denmark.

  19. Gender difference in preference of specialty as a career choice among Japanese medical students

    OpenAIRE

    Kawamoto, Ryuichi; Ninomiya, Daisuke; Kasai, Yoshihisa; Kusunoki, Tomo; Ohtsuka, Nobuyuki; Kumagi, Teru; Abe, Masanori

    2016-01-01

    Abstract Background In Japan, the absolute deficiency of doctors and maldistribution of doctors by specialty is a significant problem in the Japanese health care system. The purpose of this study was to investigate the factors contributing to specialty preference in career choice among Japanese medical students. Methods A total of 368 medical students completed the survey giving an 88.2 % response rate. The subjects comprised 141 women aged 21 ± 3 (range, 18–34) years and 227 men aged 22 ± 4 ...

  20. Preclinical tools in PET-tracer development : automatisation and biopharmaceutical evaluation with special emphasis on the adenosine A3 receptor

    International Nuclear Information System (INIS)

    Haeusler, D. I. B.

    2010-01-01

    Positron Emission Tomography (PET) is the first choice technology for the visualization and quantification of receptors and transporters, enabling examination of e.g. neurological, psychiatric and oncological diseases on a molecular level. Therefore, new and innovative PET-radiopharmaceuticals need to be developed to get further insights into the biochemical mechanisms involved in pathological changes. PET-tracer development starts with the idea or modelling of the chemical structure of a (new) molecule with (hopefully) good binding characteristics to the desired target site. As next steps, the compound needs to be synthesized and radiolabelled with a suitable PET-nuclide. Then it has to be evaluated regarding its parameters in various preclinical experimental settings. Hence, two major tools are crucial in the development-process of new PET-tracers: 1) a fast and reliable production method, most desirable and optimal in an automated set-up, and 2) proof of tracer suitability (high affinity, high selectivity and specificity, beside low unspecific binding) through preclinical evaluation in an animal model, prior to human application. Both aspects, the radiochemical preparation and automatisation, as well as the biopharmaceutical evaluation are presented in the thesis in 5 different manuscripts. In detail, the development and preclinical evaluation of 4 different PET-tracers ([11C]DASB, [18F]FE SUPPY, [18F]FE SUPPY:2, and [18F]FE CIT) for 3 targets, the serotonin transporter (SERT), the adenosine A3 receptor (A3R) and the dopamine transporter (DAT), respectively, are covered in the present thesis. The first manuscript presents a method for a fast, reliable and fully-automated radiosynthesis of [11C]DASB (a tracer for the imaging of the SERT in human brain in e.g. depression patients) will facilitate further clinical investigations (e.g. for the department of psychiatry and psychotherapy of the medical university of Vienna) with this tracer. [18F]FE SUPPY was

  1. The "high solubility" definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs.

    Science.gov (United States)

    Yazdanian, Mehran; Briggs, Katherine; Jankovsky, Corinne; Hawi, Amale

    2004-02-01

    The purpose of this study was to assess if the definition of high solubility as proposed in the FDA Guidance on Biopharmaceutical Classification System (BCS) is too strict for highly permeable acidic drugs. The solubility and permeability values of 20 (18 acidic and 2 non-acidic) nonsteroidal anti-inflammatory drugs (NSAID) were determined. The NSAIDs were grouped into three different sets having acetic acid, propionic acid, or other acidic moieties such as fenamate, oxicam, and salicylate. Two nonacidic NSAIDs (celecoxib and rofecoxib) were also included for comparison purposes. Equilibrium solubility values were determined at pH 1.2, 5.0, 7.4, and in biorelevant media simulating fed intestinal fluid at pH 5.0. For a select number of acids, we also measured solubility values in media simulating gastric and fasted intestinal fluids. Permeability classification was established relative to that of reference drugs in the Caco-2 cell permeability model. Permeability coefficients for all drugs were measured at concentrations corresponding to the lowest and highest marketed dose strengths dissolved in 250 ml volume, and their potential interaction with cellular efflux pumps was investigated. All NSAIDs with different acidic functional groups were classified as highly permeable based on their Caco-2 cell permeability. Only ketorolac appeared to have a potential for interaction with cellular efflux pumps. Solubility classification was based on comparison of equilibrium solubility at pH 1.2, 5.0. and 7.4 relative to marketed dose strengths in 250 ml. The pKa values for the acidic NSAIDs studied were between 3.5 and 5.1. and, as expected, their solubility increased dramatically at pH 7.4 compared to pH 1.2. Only three NSAIDs, ketorolac, ketoprofen. and acetyl salicylic acid, meet the current criteria for high solubility over the entire pH range. However, with the exception of ibuprofen, oxaprozin, and mefenamic acid, the remaining compounds can be classified as Class I drugs

  2. 6. Seminar of the IIE-ININ-IMP on technological specialties. Topic 8: computation

    International Nuclear Information System (INIS)

    1992-01-01

    The document includes 10 papers presented at the 6. Seminar of the IIE-ININ-IMP (Mexico) on technological specialties in the field of computation. (Topic 8). Three items were in INIS subject scope and a separate abstract was prepared for each of them

  3. 6. Seminar of the IIE-ININ-IMP on technological specialties. Topic 4: dynamics

    International Nuclear Information System (INIS)

    1992-01-01

    The document includes 7 papers presented at the 6. Seminar of the IIE-ININ-IMP (Mexico) on technological specialties in the field of dynamics. (Topic 4). One item was in INIS subject scope and a separate abstract was prepared for it

  4. The professional orientation to the masonry specialty: a system of activities

    Directory of Open Access Journals (Sweden)

    Jóse Andrés Gómez Torres

    2018-03-01

    Full Text Available The specialty Masonry in Technical and Vocational Education is of great importance given the mission that has to train workers who have to use the most efficient and updated techniques and technologies for the construction of buildings and other construction works. In the pedagogical practice manifested a contradiction expressed in the need to raise the quality of the professional training of the workers in the specialty Masonry, however, there were inadequacies in the work of professional guidance with students who attend the first year in the Polytechnical center "Leonides Blanco", reflected in the insufficient inclination towards the study profile, which led to the failure of a percentage of students. The objective of the work was to elaborate a system of activities that perfected the process of professional orientation towards the specialty Albañilería the first year at the "Leonides Blanco" PolytechnicCenter. In the investigative process, the dialectical-materialist method was assumed as the general method, which supported the theoretical methods, the application of statistical techniques that made possible the study and systematization of the theoretical and methodological foundations of the process under investigation. The practical significance is expressed in a system of activities that contributed to the professional orientation of the first-year students of the specialty Masonry, which guarantees a relevant initial training process, depending on the demands of the professional model and the needs educational and social

  5. Classification Model That Predicts Medical Students' Choices of Primary Care or Non-Primary Care Specialties.

    Science.gov (United States)

    Fincher, Ruth-Marie E.; And Others

    1992-01-01

    This study identified factors in graduating medical students' choice of primary versus nonprimary care specialty. Subjects were 509 students at the Medical College of Georgia in 1988-90. Students could be classified by such factors as desire for longitudinal patient care opportunities, monetary rewards, perception of lifestyle, and perception of…

  6. Purple Pelisse: A specialty fingerling potato with purple skin and flesh and medium specific gravity

    Science.gov (United States)

    Purple Pelisse is a specialty fingerling potato with purple skin and dark purple flesh. It has medium maturity and sets a large number of smooth, small, fingerling-shaped tubers. The tubers have medium specific gravity and high levels of antioxidants. This potato variety is mainly intended for the f...

  7. Personality Patterns of Physicians in Person-Oriented and Technique-Oriented Specialties

    Science.gov (United States)

    Borges, Nicole J.; Gibson, Denise D.

    2005-01-01

    This study investigated differences in personality patterns between person-oriented and technique-oriented physicians. It tested an integrative framework by converting the scores on the Personality Research Form (PRF) to the Big-Five factors and built a predictive model of group membership in clinical specialty area. PRF scores from 238 physicians…

  8. On the Development of Professional Competence in Students of Creative Pedagogical Specialties

    Science.gov (United States)

    Makhashova, Patima; Meirmanov, Asylbek; Zhunusbekov, Zhaxybek; Makasheva, Orynkul; Mirzaliyeva, Elmira; Ermuratova, Almagul; Sakenov, Janat

    2016-01-01

    The relevance of the topic revealed is caused by necessity to update the organization of professional activity for pedagogical higher education institution on a competence-based basis, creating conditions for developing the corresponding professional competences in students of creative pedagogical specialties. The paper addresses the structure,…

  9. 75 FR 52989 - Specialty Minerals, Inc., Franklin, VA; Notice of Negative Determination Regarding Application...

    Science.gov (United States)

    2010-08-30

    ... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-74,057] Specialty Minerals, Inc., Franklin, VA; Notice of Negative Determination Regarding Application for Reconsideration By applications dated July 9, 2010 and July 16, 2010 (filed by a company official and a worker, respectively...

  10. Patient-Centered Specialty Practice: Defining the Role of Specialists in Value-Based Health Care.

    Science.gov (United States)

    Ward, Lawrence; Powell, Rhea E; Scharf, Michael L; Chapman, Andrew; Kavuru, Mani

    2017-04-01

    Health care is at a crossroads and under pressure to add value by improving patient experience and health outcomes and reducing costs to the system. Efforts to improve the care model in primary care, such as the patient-centered medical home, have enjoyed some success. However, primary care accounts for only a small portion of total health-care spending, and there is a need for policies and frameworks to support high-quality, cost-efficient care in specialty practices of the medical neighborhood. The Patient-Centered Specialty Practice (PCSP) model offers ambulatory-based specialty practices one such framework, supported by a formal recognition program through the National Committee for Quality Assurance. The key elements of the PCSP model include processes to support timely access to referral requests, improved communication and coordination with patients and referring clinicians, reduced unnecessary and duplicative testing, and an emphasis on continuous measurement of quality, safety, and performance improvement for a population of patients. Evidence to support the model remains limited, and estimates of net costs and value to practices are not fully understood. The PCSP model holds promise for promoting value-based health care in specialty practices. The continued development of appropriate incentives is required to ensure widespread adoption. Copyright © 2017. Published by Elsevier Inc.

  11. The choice of surgery as a future career specialty among medical ...

    African Journals Online (AJOL)

    Aim: To determine the factors affecting the choice of surgery as a future career specialty among medical interns in a regional hospital in Nigeria. Method: A total of 74 junior doctors who completed internship training at the university of Benin teaching Hospital in 2012 were interviewed in this cross sectional study.

  12. 76 FR 2290 - TRICARE; Reimbursement for Travel for Specialty Care Under Exceptional Circumstances

    Science.gov (United States)

    2011-01-13

    ... or TRICARE Prime Remote. The Director, TRICARE Management Activity, shall issue procedures and... from members of the public is to make these submissions available for viewing on the Internet at http... live in certain more remote areas where there are insufficient numbers or types of specialty or...

  13. 6. Seminar of the IIE-ININ-IMP on technological specialties. Topic 3: thermal fluids

    International Nuclear Information System (INIS)

    1992-01-01

    The document includes 10 papers presented at the 6. Seminar of the IIE-ININ-IMP (Mexico) on technological specialties in the field of thermal fluids. (Topic 3). From these, 4 papers were in INIS subject scope and a separate abstract was prepared for each of them

  14. 6. Seminar of the IIE-ININ-IMP on technological specialties. Topic 13: earth sciences

    International Nuclear Information System (INIS)

    1992-01-01

    The document includes 12 papers presented at the 6. Seminar of the IIE-ININ-IMP (Mexico) on technological specialties in the field of earth sciences. (Topic 13). Four items were in INIS subject scope and a separate abstract was prepared for each of them

  15. 75 FR 41693 - Export Inspection and Weighing Waiver for High Quality Specialty Grains Transported in Containers

    Science.gov (United States)

    2010-07-19

    ... Specialty Grains Transported in Containers AGENCY: Grain Inspection, Packers and Stockyards Administration... rule to potentially make permanent the current waiver for high quality grain exported in containers... exported in containers that was established by a final rule on December 13, 2005 (70 FR 73556). This...

  16. Factors Affecting the Choice of Anesthesiology by Medical Students for Specialty Training.

    Science.gov (United States)

    Chandra, Phool; Hughes, Mark

    1984-01-01

    A study of medical students' choice of anesthesiology as a specialty and the quality of clerkships available established several factors in students' choice, including the negative effect of certified registered nurse anesthetists on the operating room floor. A study of relationships with nurse practitioners, physician's assistants, and…

  17. 75 FR 6377 - Onyx Specialty Papers, Inc.; Notice of Availability of Draft Environmental Assessment

    Science.gov (United States)

    2010-02-09

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2985-006] Onyx Specialty Papers, Inc.; Notice of Availability of Draft Environmental Assessment February 2, 2010. In accordance... lieu of paper. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii...

  18. 76 FR 19467 - Mueller Steam Specialty Formerly Known As Core Industries Including Workers Whose Unemployment...

    Science.gov (United States)

    2011-04-07

    ... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-73,851] Mueller Steam Specialty... to Apply for Worker Adjustment Assistance on October 7, 2010, applicable to workers of Mueller Steam... shows that workers separated from employment at the St. Pauls, North Carolina location of Mueller Steam...

  19. Medical Informatics Specialty in the Developed English-Speaking Countries: The Terminology Comparative Analysis

    Science.gov (United States)

    Kobryn, Nadia

    2015-01-01

    The article studies the development process of medical informatics specialty terminology as the ground for further research into foreign countries' experience, including the Canadian one, of specialists' professional training in the field of MI. The study determines the origin and chief stages of the formation and development of the medical…

  20. Are new medical students' specialty preferences gendered? Related motivational factors at a Dutch medical school.

    Science.gov (United States)

    van Tongeren-Alers, Margret; van Esch, Maartje; Verdonk, Petra; Johansson, Eva; Hamberg, Katarina; Lagro-Janssen, Toine

    2011-01-01

    Female students currently outnumber male students in most medical schools. Some medical specialties are highly gender segregated. Therefore, it is interesting to know whether medical students have early specialization preferences based on their gender. Consequently, we like to know importance stipulated to motivational factors. Our study investigates new medical students' early specialization preferences and motivational factors. New students at a Dutch medical school (n = 657) filled in a questionnaire about specialty preferences (response rate = 94%; 69.5% female, 30.5% male). The students chose out of internal medicine, psychiatry, neurology, pediatrics, surgery, gynecology and family medicine, "other" or "I don't know." Finally, they valued ten motivational factors. Forty percent of the medical students reported no specialty preference yet. Taken together, female medical students preferred pediatrics and wished to combine work and care, whereas male students opted for surgery and valued career opportunities. Gender-driven professional preferences in new medical students should be noticed in order to use competencies. Changes in specialty preferences and motivational factors in pre- and post graduates should further assess the role of medical education.

  1. 75 FR 5152 - Ancor Specialties: A Division of Hoeganaes Corporation Ridgway, PA; Notice of Revised...

    Science.gov (United States)

    2010-02-01

    ... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-71,251] Ancor Specialties: A..., resulted in a negative determination issued on October 15, 2009, was based on the finding that imports of... certification, and all workers in the group threatened with total or partial separation from employment on date...

  2. Mapping change in scientific specialties: a scientometric case study of the development or artificial intelligence

    NARCIS (Netherlands)

    van den Besselaar, P.; Leydesdorff, L.

    1996-01-01

    Has an identifiable core of activities called AI been established, during the AI-boom in the eighties? Is AI already in a “paradigmatic” phase? There has been a lot of disagreement among commentators and specialists about the nature of Artificial Intelligence as a specialty. This makes AI an

  3. 6. Seminar of the IIE-ININ-IMP on technological specialties. Topic 7: energy savings

    International Nuclear Information System (INIS)

    1992-01-01

    The document includes 6 papers presented at the 6. Seminar of the IIE-ININ-IMP (Mexico) on technological specialties in the field of energy savings. (Topic 7). One item was in INIS subject scope and a separate abstract was prepared for it

  4. Oral speech teaching to students of mathematic specialties: a grammatical aspect

    Directory of Open Access Journals (Sweden)

    Ibragimov I.I.

    2016-08-01

    Full Text Available the paper considers teaching features of English speech grammar aspects. The case studies include undergraduates of mathematical specialties. The content of students’ educational activity at the final stage of language teaching is pointed out. Besides the structure of grammar section, a special didactic training unit in which framework mastering grammar phenomena used in oral speech takes place is described.

  5. The assessment of clinical skills is imperative in postgraduate specialty training

    DEFF Research Database (Denmark)

    Tolsgaard, Martin G; Ostergaard, Doris; Konge, Lars

    2014-01-01

    According to the Danish Ministry of Health recommendations, workplace-based assessment (WPBA) should be a central component in postgraduate specialty training. In this review the potential impact of WPBA with regard to patient safety, medical licensing and effects on doctors' learning is explored...

  6. Construction and Practice of the New Business Specialty Talent Cultivation Mode

    Science.gov (United States)

    Xiao, Xiaokong

    2009-01-01

    The vocational education of business should actively adapt the demands of the domestic and foreign business development to cultivate high-quality applicable talents with international knowledge. The traditional business specialty teaching and the talent cultivation mode have not followed the domestic and foreign market demands, and are difficult…

  7. Pain medicine: The case for an independent medical specialty and training programs.

    Science.gov (United States)

    Dubois, Michel Y; Follett, Kenneth A

    2014-06-01

    Over the last 30 years, pain has become one of the most dynamic areas of medicine and a public health issue. According to a recent Institute of Medicine report, pain affects approximately 100 million Americans at an estimated annual economic cost of $560 to $635 billion and is poorly treated overall. The American Board of Medical Specialties (ABMS) recognizes a pain subspecialty, but pain care delivery has struggled with increasing demand and developed in an inconsistent and uncoordinated fashion. Pain education is insufficient and highly variable. Multiple pain professional organizations have led to fragmentation of the field and lack of interdisciplinary agreement, resulting in confusion regarding who speaks for pain medicine. In this Perspective, the authors argue that ABMS recognition of pain medicine as an independent medical specialty would provide much needed structure and oversight for the field and would generate credibility for the specialty and its providers among medical peers, payers, regulatory and legislative agencies, and the public at large. The existing system, managed by three ABMS boards, largely excludes other specialties that contribute to pain care, fails to provide leadership from a single professional organization, provides suboptimal training exposure to pain medicine, and lengthens training, which results in inefficient use of time and educational resources. The creation of a primary ABMS conjoint board in pain medicine with its own residency programs and departments would provide better coordinated training, ensure the highest degree of competence of pain medicine specialists, and improve the quality of pain care and patient safety.

  8. A patient group based business planning model for a surgical specialty

    NARCIS (Netherlands)

    Adan, I.J.B.F.; Vissers, J.M.H.; van den Heuvel, M.N.; Wiersema, K.; Vissers, J.M.H.; Beech, R.

    2005-01-01

    In this contribution we present an approach for a business planning model for a surgical specialty, based on modelling of all patient processes as well as of the dynamics involved in planning and managing resources. An important basis of the model is the description of the processes of all patient

  9. 78 FR 79658 - Okanagan Specialty Fruits, Inc.; Availability of Plant Pest Risk Assessment and Environmental...

    Science.gov (United States)

    2013-12-31

    ..., DC, this 20th day of December 2013. Kevin Shea, Administrator, Animal and Plant Health Inspection... DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2012-0025] Okanagan Specialty Fruits, Inc.; Availability of Plant Pest Risk Assessment and Environmental Assessment...

  10. Toward the establishment of a forensic nursing specialty in Brazil: an integrative literature review.

    Science.gov (United States)

    Esteves, Rafael Braga; Lasiuk, Gerri C; Cardoso, Lucilene; Kent-Wilkinson, Arlene

    2014-01-01

    Over the past two decades, Brazil has made progress in bringing political and community attention to issues related to violence. The recognition of links between violence and health has intensified calls to accelerate the development of a forensic nursing specialty in Brazil. The aim of this study was to systematically examine and synthesize the literature on the development of the forensic nursing specialty around the globe and to extract important lessons for the establishment of a forensic nursing specialty in Brazil. An integrative review was conducted according to the method described by Whittmore and Knafl (2005). Electronic searches of the following databases were conducted between December 2012 and March 2013: CINAHL Plus with Full Text, Criminal Justice, Index to Legal periodicals, MEDLINE, Soc Index with Full Text, Social Work Abstracts, SCOPUS, and PsycINFO. The search terms used were: [(TI nurs* or SU nurs*) and [TI (forensic* or penal or prison*) or SU (forensic* or penal or prison*)] and (sexual assault nurse examiner*). Preestablished inclusion/exclusion criteria were used to select published articles for review. Twenty-three articles met inclusion criteria and were included in the full review. Important lessons for Brazil are discussed in terms of education and curricular issues and forensic psychiatric nursing. In Brazil, there is a window of opportunity to contribute the theoretical foundations of forensic nursing science and to advance nursing specialty practice in the areas of Sexual Assault Nurse Examiners and forensic psychiatric nurses.

  11. The relation between specialty choice of psychology students and their interests, personality, and cognitive abilities

    NARCIS (Netherlands)

    Wicherts, J.M.; Vorst, H.C.M.

    2010-01-01

    The aim of this longitudinal study was to investigate differences in interests, personality, and cognitive abilities between students majoring in the six specialties of psychology at the University of Amsterdam. Results show that students at Social Psychology and Work and Organizational Psychology

  12. Influence of gender and other factors on medical student specialty interest.

    Science.gov (United States)

    Boyle, Veronica; Shulruf, Boaz; Poole, Phillippa

    2014-09-12

    Medical schools must select and educate to meet anticipated health needs. Factors influencing career choice include those of the student and their background as well as subsequent experience. Women have comprised over 50% of medical classes for over 20 years. This study describes gender patterns of current specialty interest among medical students at the University of Auckland, and models the predictive effect of gender compared to other career influencing factors. The study analysed career intention survey data from 711 graduating medical students (response rate, 79%) from 2006 to 2011. Interest level was highest for medicine, followed by subspecialty surgery, general practice and paediatrics. There were differences by gender for most specialties, but not for general practice. Women were more likely than men to be interested in Obstetrics and Gynaecology, Paediatrics, Geriatrics, Public Health or General Medicine, and less interested in Surgery, Anaesthesia, Emergency Medicine or post graduate study. Each specialty had a different pattern of influencing factors with the most important factor being the experience on a clinical attachment. Factors in career choice are complex and vary by gender and specialty. General practice levels of interest are too low for workforce needs. Predictive models need to be validated in longer term studies but may help guide selection and curriculum design.

  13. Artificial intelligence in radiation oncology: A specialty-wide disruptive transformation?

    Science.gov (United States)

    Thompson, Reid F; Valdes, Gilmer; Fuller, Clifton D; Carpenter, Colin M; Morin, Olivier; Aneja, Sanjay; Lindsay, William D; Aerts, Hugo J W L; Agrimson, Barbara; Deville, Curtiland; Rosenthal, Seth A; Yu, James B; Thomas, Charles R

    2018-06-12

    Artificial intelligence (AI) is emerging as a technology with the power to transform established industries, and with applications from automated manufacturing to advertising and facial recognition to fully autonomous transportation. Advances in each of these domains have led some to call AI the "fourth" industrial revolution [1]. In healthcare, AI is emerging as both a productive and disruptive force across many disciplines. This is perhaps most evident in Diagnostic Radiology and Pathology, specialties largely built around the processing and complex interpretation of medical images, where the role of AI is increasingly seen as both a boon and a threat. In Radiation Oncology as well, AI seems poised to reshape the specialty in significant ways, though the impact of AI has been relatively limited at present, and may rightly seem more distant to many, given the predominantly interpersonal and complex interventional nature of the specialty. In this overview, we will explore the current state and anticipated future impact of AI on Radiation Oncology, in detail, focusing on key topics from multiple stakeholder perspectives, as well as the role our specialty may play in helping to shape the future of AI within the larger spectrum of medicine. Published by Elsevier B.V.

  14. The Relation between Specialty Choice of Psychology Students and Their Interests, Personality, and Cognitive Abilities

    Science.gov (United States)

    Wicherts, Jelte M.; Vorst, Harrie C. M.

    2010-01-01

    The aim of this longitudinal study was to investigate differences in interests, personality, and cognitive abilities between students majoring in the six specialties of psychology at the University of Amsterdam. Results show that students at Social Psychology and Work and Organizational Psychology were on average more extraverted than students of…

  15. Medical Imaging Field of Magnetic Resonance Imaging: Identification of Specialties within the Field

    Science.gov (United States)

    Grey, Michael L.

    2009-01-01

    This study was conducted to determine if specialty areas are emerging in the magnetic resonance imaging (MRI) profession due to advancements made in the medical sciences, imaging technology, and clinical applications used in MRI that would require new developments in education/training programs and national registry examinations. In this…

  16. Emergency medicine journal impact factor and change compared to other medical and surgical specialties.

    Science.gov (United States)

    Reynolds, Joshua C; Menegazzi, James J; Yealy, Donald M

    2012-11-01

    A journal impact factor represents the mean number of citations per article published. Designed as one tool to measure the relative importance of a journal, impact factors are often incorporated into academic evaluation of investigators. The authors sought to determine how impact factors of emergency medicine (EM) journals compare to journals from other medical and surgical specialties and if any change has taken place over time. The 2010 impact factors and 5-year impact factors for each journal indexed by the Thomson Reuters ISI Web of Knowledge Journal Citation Reports (JCR) were collected, and EM, medical, and surgical specialties were evaluated. The maximum, median, and interquartile range (IQR) of the current impact factor and 5-year impact factor in each journal category were determined, and specialties were ranked according to the summary statistics. The "top three" impact factor journals for each specialty were analyzed, and growth trends from 2001 through 2010 were examined with random effects linear regression. Data from 2,287 journals in 31 specialties were examined. There were 23 EM journals with a current maximum impact factor of 4.177, median of 1.269, and IQR of 0.400 to 2.176. Of 23 EM journals, 57% had a 5-year impact factor available, with a maximum of 4.531, median of 1.325, and IQR of 0.741 to 2.435. The top three EM journals had a mean standard deviation (±SD) impact factor of 3.801 (±0.621) and median of 4.142 and a mean (±SD) 5-year impact factor of 3.788 (±1.091) and median of 4.297, with a growth trend of 0.211 (95% confidence interval [CI] = 0.177 to 0.245; p journals ranked no higher than 24th among 31 specialties. Emergency medicine journals rank low in impact factor summary statistics and growth trends among 31 medical and surgical specialties. © 2012 by the Society for Academic Emergency Medicine.

  17. Dental student perceptions of oral and maxillofacial surgery as a specialty.

    Science.gov (United States)

    Jarosz, Krystian F; Ziccardi, Vincent B; Aziz, Shahid R; Sue-Jiang, Shuying

    2013-05-01

    The specialty of oral and maxillofacial surgery (OMS) encompasses the diagnosis and surgical management of a variety of pathologic, functional, and esthetic conditions of the oral and maxillofacial region. Despite the specialty's prominent role in the field of dentistry, a lack of complete understanding still remains among dental and medical health professionals as to the exact scope and expertise of the oral and maxillofacial surgeon. The present study aimed to analyze a population of dental students' perceptions of OMS as a specialty with respect to treatment rendered, referral patterns, and a general opinion of the specialty as a whole. A survey consisting of 10 multiple-choice questions was compiled and distributed to dental students through an on-line polling service (SurveyMonkey). A total of 5 dental student classes at a single dental school were polled using school-based electronic mail, including the graduating seniors. All answers were kept confidential, and no individual students were identified. The students were not able to retake the survey once completed. The final tallies of the survey results were compiled and submitted for statistical analysis. Statistically significant associations between the year of dental education and student perceptions of OMS were determined. As dental students progress through their undergraduate studies, their perceptions change with regard to the referral of dental implants. Periodontists were found to have statistically significantly greater rates of referral than oral and maxillofacial surgeons from dental students in the fourth year and recent graduates compared with younger dental students from the first, second, and third years for placement of dental implants. Statistically insignificant in terms of a changing dental student perception was the finding that third molar removal was within the domain of the oral and maxillofacial surgeon, as well as the management of cleft lip and palate deformities and mandibular

  18. Evaluation of the membrane permeability (PAMPA and skin) of benzimidazoles with potential cannabinoid activity and their relation with the Biopharmaceutics Classification System (BCS).

    Science.gov (United States)

    Alvarez-Figueroa, M Javiera; Pessoa-Mahana, C David; Palavecino-González, M Elisa; Mella-Raipán, Jaime; Espinosa-Bustos, Cristián; Lagos-Muñoz, Manuel E

    2011-06-01

    The permeability of five benzimidazole derivates with potential cannabinoid activity was determined in two models of membranes, parallel artificial membrane permeability assay (PAMPA) and skin, in order to study the relationship of the physicochemical properties of the molecules and characteristics of the membranes with the permeability defined by the Biopharmaceutics Classification System. It was established that the PAMPA intestinal absorption method is a good predictor for classifying these molecules as very permeable, independent of their thermodynamic solubility, if and only if these have a Log P(oct) value permeability is conditioned on the solubility of the molecule so that it can only serve as a model for classifying the permeability of molecules that possess high solubility (class I: high solubility, high permeability; class III: high solubility, low permeability).

  19. Perceived Health Status and Utilization of Specialty Care: Racial and Ethnic Disparities in Patients with Chronic Diseases

    Science.gov (United States)

    Glover, Saundra; Bellinger, Jessica D.; Bae, Sejong; Rivers, Patrick A.; Singh, Karan P.

    2010-01-01

    Objective: The objective of this study is to determine racial and ethnic variations in specialty care utilization based on (a) perceived health status and (b) chronic disease status. Methods: Variations in specialty care utilization, by perceived health and chronic disease status, were examined using the Commonwealth Fund Health Care Quality…

  20. 77 FR 6584 - Specialty Bar Products Company,a Subsidiary of Doncasters, Inc., Blairsville, PA; Notice of...

    Science.gov (United States)

    2012-02-08

    ... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-80,511] Specialty Bar Products Company,a Subsidiary of Doncasters, Inc., Blairsville, PA; Notice of Affirmative Determination Regarding... Assistance (TAA) applicable to workers and former workers of Specialty Bar Products Company, a subsidiary of...

  1. The dynamics of triads in aggregated journal-journal citation relations: specialty developments at the above-journal level

    NARCIS (Netherlands)

    de Nooy, W.; Leydesdorff, L.

    2015-01-01

    Dyads of journals—related by citations—can agglomerate into specialties through the mechanism of triadic closure. Using the Journal Citation Reports 2011, 2012, and 2013, we analyze triad formation as indicators of integration (specialty growth) and disintegration (restructuring). The strongest

  2. 76 FR 50285 - Fiscal Year 2012 Tariff-Rate Quota Allocations for Raw Cane Sugar, Refined and Specialty Sugar...

    Science.gov (United States)

    2011-08-12

    ... for Raw Cane Sugar, Refined and Specialty Sugar and Sugar-Containing Products AGENCY: Office of the... quantity of the tariff-rate quotas for imported raw cane sugar, refined and specialty sugar and sugar...), the United States maintains tariff-rate quotas (TRQs) for imports of raw cane sugar and refined sugar...

  3. 77 FR 57180 - Fiscal Year 2013 Tariff-rate Quota Allocations for Raw Cane Sugar, Refined and Specialty Sugar...

    Science.gov (United States)

    2012-09-17

    ... Sugar, Refined and Specialty Sugar, and Sugar-Containing Products AGENCY: Office of the United States... quantity of the tariff-rate quotas for imported raw cane sugar, refined and specialty sugar, and sugar... imports of raw cane sugar and refined sugar. Pursuant to Additional U.S. Note 8 to Chapter 17 of the HTS...

  4. The Effect of Teaching Experience and Specialty (Vocal or Instrumental) on Vocal Health Ratings of Music Teachers

    Science.gov (United States)

    Hackworth, Rhonda S.

    2010-01-01

    The current study sought to determine the relationship among music teachers' length of teaching experience, specialty (vocal or instrumental), and ratings of behaviors and teaching activities related to vocal health. Participants (N = 379) were experienced (n = 208) and preservice (n = 171) music teachers, further categorized by specialty, either…

  5. Agile Model Driven Development of Electronic Health Record-Based Specialty Population Registries

    Science.gov (United States)

    Kannan, Vaishnavi; Fish, Jason C.; Willett, DuWayne L.

    2018-01-01

    The transformation of the American healthcare payment system from fee-for-service to value-based care increasingly makes it valuable to develop patient registries for specialized populations, to better assess healthcare quality and costs. Recent widespread adoption of Electronic Health Records (EHRs) in the U.S. now makes possible construction of EHR-based specialty registry data collection tools and reports, previously unfeasible using manual chart abstraction. But the complexities of specialty registry EHR tools and measures, along with the variety of stakeholders involved, can result in misunderstood requirements and frequent product change requests, as users first experience the tools in their actual clinical workflows. Such requirements churn could easily stall progress in specialty registry rollout. Modeling a system’s requirements and solution design can be a powerful way to remove ambiguities, facilitate shared understanding, and help evolve a design to meet newly-discovered needs. “Agile Modeling” retains these values while avoiding excessive unused up-front modeling in favor of iterative incremental modeling. Using Agile Modeling principles and practices, in calendar year 2015 one institution developed 58 EHR-based specialty registries, with 111 new data collection tools, supporting 134 clinical process and outcome measures, and enrolling over 16,000 patients. The subset of UML and non-UML models found most consistently useful in designing, building, and iteratively evolving EHR-based specialty registries included User Stories, Domain Models, Use Case Diagrams, Decision Trees, Graphical User Interface Storyboards, Use Case text descriptions, and Solution Class Diagrams. PMID:29750222

  6. Empathy differences by gender and specialty preference in medical students: a study in Brazil.

    Science.gov (United States)

    Santos, Mariana A; Grosseman, Suely; Morelli, Thiago C; Giuliano, Isabela C B; Erdmann, Thomas R

    2016-05-21

    We have conducted this study to assess medical students' empathy and to examine empathy differences by students' socio-demographic characteristics, including gender, and specialty preference. We have conducted a cross-sectional and descriptive research. Among 595 medical students registered at the Federal University of Santa Catarina (Brazil) in 2012, we have selected a sample of 320 enrolled in the first, third, fifth, seventh, ninth, eleventh, and in the last semester of the course. The response rate obtained was 70.6% (n=226). Data was collected by using a self-report questionnaire, and the variables analyzed included course semester, socio-demographic characteristics (such as age, gender, household monthly income and parents level of education), students' specialty preference, and empathy assessed by the Jefferson Scale of Empathy. We have used descriptive statistics, 95% Confidence Interval for percentages, Student's t-test, and Analysis of Variance to analyze the data. Mean empathy among students was (M=119.7, SD=9.9), with no difference by according to semester (F=1.5, p=.2). Empathy means were higher among females (M=118.3, SD=10.6) than among males (M=121.0, SD=9.3, t=-2.1, p=.032). Students who preferred a people-oriented specialty obtained significantly higher mean scores (M=121.5, SD=8.1) in comparison to students who preferred technology-oriented specialties (M=118.0, SD=11.3, t=2.4, p=.02). Our study has found consistently high scores of empathy among medical students enrolled in all levels of training at the Federal University of Santa Catarina, and higher empathy among women and students who intend to pursue a people-oriented specialty. Conclusions on higher empathy among medical students require further study.

  7. High and specialty-related musculoskeletal disorders afflict dental professionals even since early training years

    Directory of Open Access Journals (Sweden)

    Jianru YI

    2013-07-01

    Full Text Available OBJECTIVE: To determine how early musculoskeletal disorders (MSDs develop in dental professionals and to explore the potential differences among distinct dental specialties. MATERIAL AND METHODS: 271 dental postgraduates majoring in five dental specialties were recruited, i.e., orthodontics, prosthodontics, endodontics, periodontics and alveolar surgery. 254 age-matched non-dental postgraduates served as the control. The standardized Nordic questionnaire on MSDs and a self-report questionnaire regarding correlative factors (only for dental postgraduates were answered through emails. Reliability of responses was assessed applying test-retest method. RESULTS: The intraclass correlation coefficient of participants' answers ranged from 0.89 to 0.96. Dental postgraduates had significantly higher prevalence of MSDs than the control group, especially at neck, upper back and lower back. In all dental specialties included, high prevalence of MSDs was reported at neck (47.5%-69.8%, shoulders (50.8%-65.1%, lower back (27.1%-51.2% and upper back (25.6%-46.5%, with lower prevalence at elbows (5.1%-18.6%, hips (3.4%-16.3% and ankles (5.1%-11.6%. Periodontics students reported the worst MSDs in most body regions except wrists and knees, which were more prevalent for prosthodontic and alveolar surgery students, respectively. Furthermore, year of clinical work, clinical hours per week and desk hours per week were found as risk factors for MSDs, whereas physical exercise and rest between patients as protective factors. CONCLUSIONS: High and specialty-related MSDs afflict dental professionals even since very early stage of careers. Prevention aimed at the specialty-related characteristics and the risk/protective factors revealed in this study should be introduced to dental personnel as early as possible.

  8. Impact of a national specialty e-consultation implementation project on access.

    Science.gov (United States)

    Kirsh, Susan; Carey, Evan; Aron, Dacid C; Cardenas, Omar; Graham, Glenn; Jain, Rajiv; Au, David H; Tseng, Chin-Lin; Franklin, Heather; Ho, P Michael

    2015-12-01

    To assess the early impact of implementation of the electronic consults (e-consults) initiative by the Veterans Health Administration (VHA), designed to improve specialty care access. Observational cohort study exploiting a natural experiment begun in May 2011 at 12 VHA medical centers and expanded to 122 medical centers by December 2013. The following were assessed: 1) growth of e-consults by VHA regional networks, medical centers, and specialty; 2) location of patient's primary care provider (medical center vs community-based outpatient clinic [CBOC]); 3) potential patient miles needed to travel for a specialty care face-to-face consult in place of the observed e-consults using estimated geodesic distance; 4) use of specialty care subsequent to the e-consult. Of 11,270,638 consults completed in 13 clinics of interest, 217,014 were e-consults (adjusted rate, 1.93 e-consults per 100 consults). The e-consult rate was highest in endocrinology (5.0 per 100), hematology (3.0 per 100), and gastroenterology (3.0 per 100). The percentage of e-consult patients with CBOC-based primary care grew from 28.5% to 44.4% in the first year of implementation and to 45.6% at year 3. Of those e-consult patients from community clinics, the average potential miles needed to travel was 72.1 miles per patient (SD = 72.6; median = 54.6; interquartile range = 17.1-108), translating to a potential savings of 6,875,631 total miles and travel reimbursement costs of $2,853,387. E-consult volume increased significantly since inception within many medical and surgical specialties. For patients receiving primary care at one of more than 800 CBOCs, e-consults may decrease travel burden and direct travel costs for patients.

  9. Access to specialty care in autism spectrum disorders-a pilot study of referral source

    Directory of Open Access Journals (Sweden)

    West Therese

    2011-05-01

    Full Text Available Abstract Background In the United States, a medical home model has been shown to improve the outcomes for children with special health care needs. As part of this model, primary care physicians provide comprehensive medical care that includes identification of delayed and/or atypical development in children and coordination of care with specialists. However, it is not clear if families of children with Autism Spectrum Disorder (ASD rely on the medical home model for care of their child to the same extent as families of children with other special health care needs. This study aims to add to the understanding of medical care for children with ASD by examining the referral source for specialty care. Methods This retrospective study was accomplished by evaluating parent completed intake data for children with ASD compared to those with other neurological disorders in a single physician Pediatric Neurology Practice at a major urban medical center in Northern New Jersey. To account for referral bias, a similar comparison study was conducted using a multispecialty ASD practice at the same medical center. Parent reported "source of referral" and "reason for the referral" of 189 ASD children and 108 non-ASD neurological disordered children were analyzed. Results The specialty evaluations of ASD were predominantly parent initiated. There were significantly less referrals received from primary care physicians for children with ASD compared to children with other neurodevelopmental disorders. Requirement of an insurance referral was not associated with a primary care physician prompted specialty visit.We identified different patterns of referral to our specialty clinics for children with ASD vs. children with other neurolodevelopmental disorders. Conclusion The majority of the families of children with ASD evaluated at our autism center did not indicate that a primary care physician initiated the specialty referral. This study suggests that families of

  10. Improving the communication between teams managing boarded patients on a surgical specialty ward.

    Science.gov (United States)

    Puvaneswaralingam, Shobitha; Ross, Daniella

    2016-01-01

    Transferring patients from the ward of their specialty or consultant is described as boarding. 1 Boarding patients is becoming increasingly prevalent due to greater pressure on hospital capacity. This practice compromises patient safety through delayed investigations, prolonged hospital stays, and increased risk of hospital-acquired infections. 1 2 We evaluated how regularly boarded patients were reviewed, and how effectively information regarding their management was communicated from their primary specialty to ward staff. We aimed to improve the frequency of patient reviews by ensuring that each patient was reviewed every weekday and increase communication between primary specialty, and medical and nursing teams by 20% from baseline during the data collection period. The project was based in the Otolaryngology ward in Ninewells Hospital, Dundee, where there was a high prevalence of boarded patients. Baseline data showed a clear deficit in communication between the primary specialty and ward staff with only 31% of patient reviews being communicated to ward doctors. We designed and implemented a communication tool, in the form of a sticker, to be inserted into patients' medical notes for use by the primary specialty. Implementation of the sticker improved communication between teams as stickers were completed in 93% of instances. In 88% of patient reviews, the junior doctor was informed of the management plan, showing a large increase from baseline. Through PDSA cycles, we aimed to increase the sustainability and reliability of the sticker; however, we faced challenges with sustainability of sticker insertion. We aim to engage more stakeholders to raise awareness of the problem, brainstorm solutions together, and review the production and implementation of stickers with senior hospital management to discuss the potential use of this tool within practice. There is potentially a large scope for utilisation of this communication tool on a local level, which we hope

  11. Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium.

    Science.gov (United States)

    Rup, B; Pallardy, M; Sikkema, D; Albert, T; Allez, M; Broet, P; Carini, C; Creeke, P; Davidson, J; De Vries, N; Finco, D; Fogdell-Hahn, A; Havrdova, E; Hincelin-Mery, A; C Holland, M; H Jensen, P E; Jury, E C; Kirby, H; Kramer, D; Lacroix-Desmazes, S; Legrand, J; Maggi, E; Maillère, B; Mariette, X; Mauri, C; Mikol, V; Mulleman, D; Oldenburg, J; Paintaud, G; R Pedersen, C; Ruperto, N; Seitz, R; Spindeldreher, S; Deisenhammer, F

    2015-09-01

    Biopharmaceuticals (BPs) represent a rapidly growing class of approved and investigational drug therapies that is contributing significantly to advancing treatment in multiple disease areas, including inflammatory and autoimmune diseases, genetic deficiencies and cancer. Unfortunately, unwanted immunogenic responses to BPs, in particular those affecting clinical safety or efficacy, remain among the most common negative effects associated with this important class of drugs. To manage and reduce risk of unwanted immunogenicity, diverse communities of clinicians, pharmaceutical industry and academic scientists are involved in: interpretation and management of clinical and biological outcomes of BP immunogenicity, improvement of methods for describing, predicting and mitigating immunogenicity risk and elucidation of underlying causes. Collaboration and alignment of efforts across these communities is made difficult due to lack of agreement on concepts, practices and standardized terms and definitions related to immunogenicity. The Innovative Medicines Initiative (IMI; www.imi-europe.org), ABIRISK consortium [Anti-Biopharmaceutical (BP) Immunization Prediction and Clinical Relevance to Reduce the Risk; www.abirisk.eu] was formed by leading clinicians, academic scientists and EFPIA (European Federation of Pharmaceutical Industries and Associations) members to elucidate underlying causes, improve methods for immunogenicity prediction and mitigation and establish common definitions around terms and concepts related to immunogenicity. These efforts are expected to facilitate broader collaborations and lead to new guidelines for managing immunogenicity. To support alignment, an overview of concepts behind the set of key terms and definitions adopted to date by ABIRISK is provided herein along with a link to access and download the ABIRISK terms and definitions and provide comments (http://www.abirisk.eu/index_t_and_d.asp). © 2015 British Society for Immunology.

  12. Does a single specialty intensive care unit make better business sense than a multi-specialty intensive care unit? A costing study in a trauma center in India

    Science.gov (United States)

    Kumar, Parmeshwar; Jithesh, Vishwanathan; Gupta, Shakti Kumar

    2015-01-01

    Context: Though intensive care units (ICUs) only account for 10% of hospital beds, they consume nearly 22% of hospital resources. Few definitive costing studies have been conducted in Indian settings that would help determine appropriate resource allocation. Aim: To evaluate and compare the cost of intensive care delivery between multi-specialty and neurosurgery ICU in an apex trauma care facility in India. Materials and Methods: The study was conducted in a polytrauma and neurosurgery ICU at a 203 bedded level IV trauma care facility in New Delhi, India from May, 2012 to June 2012. The study was cross-sectional, retrospective, and record-based. Traditional costing was used to arrive at the cost for both direct and indirect cost estimates. The cost centers included in study were building cost, equipment cost, human resources, materials and supplies, clinical and nonclinical support services, engineering maintenance cost, and biomedical waste management. Statistical Analysis: Fisher's two-tailed t-test. Results: Total cost/bed/day for the multi-specialty ICU was Rs. 14,976.9/- and for the neurosurgery ICU was Rs. 14,306.7/-, manpower constituting nearly half of the expenditure in both ICUs. The cost center wise and overall difference in the cost among the ICUs were statistically significant. Conclusions: Quantification of expenditure in running an ICU in a trauma center would assist healthcare decision makers in better allocation of resources. Although multi-specialty ICUs are more expensive, other factors will also play a role in defining the kind of ICU that need to be designed. PMID:25829909

  13. Does a single specialty intensive care unit make better business sense than a multi-specialty intensive care unit? A costing study in a trauma center in India

    Directory of Open Access Journals (Sweden)

    Parmeshwar Kumar

    2015-01-01

    Full Text Available Context: Though intensive care units (ICUs only account for 10% of hospital beds, they consume nearly 22% of hospital resources. Few definitive costing studies have been conducted in Indian settings that would help determine appropriate resource allocation. Aim: To evaluate and compare the cost of intensive care delivery between multi-specialty and neurosurgery ICU in an apex trauma care facility in India. Materials and Methods: The study was conducted in a polytrauma and neurosurgery ICU at a 203 bedded level IV trauma care facility in New Delhi, India from May, 2012 to June 2012. The study was cross-sectional, retrospective, and record-based. Traditional costing was used to arrive at the cost for both direct and indirect cost estimates. The cost centers included in study were building cost, equipment cost, human resources, materials and supplies, clinical and nonclinical support services, engineering maintenance cost, and biomedical waste management. Statistical Analysis: Fisher′s two-tailed t-test. Results: Total cost/bed/day for the multi-specialty ICU was Rs. 14,976.9/- and for the neurosurgery ICU was Rs. 14,306.7/-, manpower constituting nearly half of the expenditure in both ICUs. The cost center wise and overall difference in the cost among the ICUs were statistically significant. Conclusions: Quantification of expenditure in running an ICU in a trauma center would assist healthcare decision makers in better allocation of resources. Although multi-specialty ICUs are more expensive, other factors will also play a role in defining the kind of ICU that need to be designed.

  14. Just fun or a prejudice? - physician stereotypes in common jokes and their attribution to medical specialties by undergraduate medical students.

    Science.gov (United States)

    Harendza, Sigrid; Pyra, Martin

    2017-07-26

    Many jokes exist about stereotypical attributes of physicians in various specialties, which could lead to prejudices against physicians from a specific specialty. It is unknown whether and when medical students are aware of stereotypes about different specialties. The goal of this study was to analyze the degree of stereotypes that exist about medical specialties amongst undergraduate medical students at different stages of their education. One hundred fifty-two jokes with different content about attributes of physicians from different specialties were found by an internet search. In total, 36 characteristics of the five specialties of anesthesia, general surgery, internal medicine, orthopedics, and psychiatry were extracted from the jokes and they constituted the basis for the development of an online questionnaire. The questionnaire allowed each characteristic to be assigned to one of the five specialties and was sent to 999 undergraduate medical students from semester 1, 7, and 12 at the Medical Faculty of Hamburg University. Three hundred eight (30.8%) of the invited students completed the survey. The characteristics of general surgeons and psychiatrists were assigned congruently most frequently (>50%). For internists and orthopedics, there was a significantly more congruent assignment of the characteristics by final year students versus students in their first semester. Male students assigned the characteristics of anesthetists and internists significantly more congruently than female students. The three characteristics "…are a bit slow on the uptake", "…consider income to be relatively unimportant", and "...apologize a lot" were not assigned to any of the five specialties by more than 50% of the students. While stereotypes about physicians from certain specialties seem to exist commonly, medical educators need to be aware that stereotypes about specialties might develop during undergraduate medical training. In order to support students in their

  15. An International, Multi-Specialty Validation Study of the IgG4-Related Disease Responder Index.

    Science.gov (United States)

    Wallace, Zachary S; Khosroshahi, Arezou; Carruthers, Mollie D; Perugino, Cory A; Choi, Hyon; Campochiaro, Corrado; Culver, Emma L; Cortazar, Frank; Della-Torre, Emanuel; Ebbo, Mikael; Fernandes, Ana; Frulloni, Luca; Hart, Philip; Karadag, Omer; Kawa, Shigeyuki; Kawano, Mitsuhiro; Kim, Myung-Hwan; Lanzillotta, Marco; Matsui, Shoko; Okazaki, Kazuichi; Ryu, Jay H; Saeki, Takako; Schleinitz, Nicolas; Tanasa, Paula; Umehara, Hisanori; Webster, George; Zhang, Wen; Stone, John H

    2018-02-18

    IgG4-related disease (IgG4-RD) can cause fibro-inflammatory lesions in nearly any organ, leading to organ dysfunction and failure. The IgG4-RD Responder Index (RI) was developed to help investigators assess the efficacy of treatment in a structured manner. We sought to validate the RI in a multi-national investigation. The RI guides investigators through assessments of disease activity and damage in 25 domains, incorporating higher weights for disease manifestations that require treatment urgently or that worsen despite treatment. After a training exercise, investigators reviewed 12 written IgG4-RD vignettes (mean length: 279 words, range: 76-511 words) based upon real patients. Investigators calculated both an RI score as well as a physician global assessment (PGA) for each vignette. Three investigators used the RI on fifteen patients followed over serial visits after treatment. We assessed inter- and intra-rater reliability, precision, validity, and responsiveness. Twenty-six physician-investigators included representatives from 6 specialties and 9 countries. The inter-rater and intra-rater reliabilities of the RI were strong (0.88 and 0.69, respectively) and superior to those of the PGA. Correlations (construct validity) between the RI and PGA were high (Spearman's r=0.9, Preliable disease activity assessment tool that can be used to measure response to therapy. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  16. Primary care specialty career choice among Canadian medical students: Understanding the factors that influence their decisions.

    Science.gov (United States)

    Osborn, Heather Ann; Glicksman, Jordan T; Brandt, Michael G; Doyle, Philip C; Fung, Kevin

    2017-02-01

    To identify which factors influence medical students' decision to choose a career in family medicine and pediatrics, and which factors influence their decision to choose careers in non-front-line specialties. Survey that was created based on a comprehensive literature review to determine which factors are considered important when choosing practice specialty. Ontario medical school. An open cohort of medical students in the graduating classes of 2008 to 2011 (inclusive). The main factors that influenced participants' decision to choose a career in primary care or pediatrics, and the main factors that influenced participants' decision to choose a career in a non-front-line specialty. A total of 323 participants were included in this study. Factors that significantly influenced participants' career choice in family medicine or pediatrics involved work-life balance (acceptable hours of practice [ P = .005], acceptable on-call demands [ P = .012], and lifestyle flexibility [ P = .006]); a robust physician-patient relationship (ability to promote individual health promotion [ P = .014] and the opportunity to form long-term relationships [ P  < .001], provide comprehensive care [ P = .001], and treat patients and their families [ P = .006]); and duration of residency program ( P = .001). The career-related factors that significantly influenced participants' decision to choose a non-front-line specialty were as follows: becoming an expert ( P  < .001), maintaining a focused scope of practice ( P  < .001), having a procedure-focused practice ( P = .001), seeing immediate results from one's actions ( P  < .001), potentially earning a high income ( P  < .001), and having a perceived status among colleagues ( P  < .001). In this study, 8 factors were found to positively influence medical students' career choice in family medicine and pediatrics, and 6 factors influenced the decision to choose a career in a non-front-line specialty. Medical students can be

  17. Challenges in referral communication between VHA primary care and specialty care.

    Science.gov (United States)

    Zuchowski, Jessica L; Rose, Danielle E; Hamilton, Alison B; Stockdale, Susan E; Meredith, Lisa S; Yano, Elizabeth M; Rubenstein, Lisa V; Cordasco, Kristina M

    2015-03-01

    Poor communication between primary care providers (PCPs) and specialists is a significant problem and a detriment to effective care coordination. Inconsistency in the quality of primary-specialty communication persists even in environments with integrated delivery systems and electronic medical records (EMRs), such as the Veterans Health Administration (VHA). The purpose of this study was to measure ease of communication and to characterize communication challenges perceived by PCPs and primary care personnel in the VHA, with a particular focus on challenges associated with referral communication. The study utilized a convergent mixed-methods design: online cross-sectional survey measuring PCP-reported ease of communication with specialists, and semi-structured interviews characterizing primary-specialty communication challenges. 191 VHA PCPs from one regional network were surveyed (54% response rate), and 41 VHA PCPs and primary care staff were interviewed. PCP-reported ease of communication mean score (survey) and recurring themes in participant descriptions of primary-specialty referral communication (interviews) were analyzed. Among PCPs, ease-of-communication ratings were highest for women's health and mental health (mean score of 2.3 on a scale of 1-3 in both), and lowest for cardiothoracic surgery and neurology (mean scores of 1.3 and 1.6, respectively). Primary care personnel experienced challenges communicating with specialists via the EMR system, including difficulty in communicating special requests for appointments within a certain time frame and frequent rejection of referral requests due to rigid informational requirements. When faced with these challenges, PCPs reported using strategies such as telephone and e-mail contact with specialists with whom they had established relationships, as well as the use of an EMR-based referral innovation called "eConsults" as an alternative to a traditional referral. Primary-specialty communication is a continuing

  18. Gender difference in preference of specialty as a career choice among Japanese medical students

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    Ryuichi Kawamoto

    2016-11-01

    Full Text Available Abstract Background In Japan, the absolute deficiency of doctors and maldistribution of doctors by specialty is a significant problem in the Japanese health care system. The purpose of this study was to investigate the factors contributing to specialty preference in career choice among Japanese medical students. Methods A total of 368 medical students completed the survey giving an 88.2 % response rate. The subjects comprised 141 women aged 21 ± 3 (range, 18–34 years and 227 men aged 22 ± 4 (range, 18–44 years. Binary Logistic regression analysis was performed using specialty preferences as the criterion variable and the factors in brackets as six motivational variables (e.g., Factor 1: educational experience; Factor 2: job security; Factor 3: advice from others; Factor 4: work-life balance; Factor 5: technical and research specialty; and Factor 6: personal reasons. Results Women significantly preferred pediatrics, obstetrics & gynecology, and psychology than the men. Men significantly preferred surgery and orthopedics than the women. For both genders, a high odds ratio (OR of “technical & research specialty” and a low OR for “personal reasons” were associated with preference for surgery. “Technical & research specialty” was positively associated with preference for special internal medicine and negatively for pediatrics. “Work-life balance” was positively associated with preference for psychology and negatively for emergency medicine. Among the women only, “technical & research specialty” was negatively associated with preference for general medicine/family medicine and obstetrics & gynecology, and “job security” was positively associated for general medicine/family medicine and negatively for psychology. Among men only, “educational experience” and “personal reasons” were positively, and “job security” was negatively associated with preference for pediatrics. For both genders,

  19. Evaluation of HIV testing recommendations in specialty guidelines for the management of HIV indicator conditions

    DEFF Research Database (Denmark)

    Lord, E; Stockdale, A J; Malek, R

    2017-01-01

    OBJECTIVES: European guidelines recommend HIV testing for individuals presenting with indicator conditions (ICs) including AIDS-defining conditions (ADCs). The extent to which non-HIV specialty guidelines recommend HIV testing in ICs and ADCs is unknown. Our aim was to pilot a methodology in the UK...... are piloting methods to engage with guideline development groups to ensure that patients diagnosed with ICs/ADCs are tested for HIV. We then plan to apply our methodology in other European settings as part of the Optimising Testing and Linkage to Care for HIV across Europe (OptTEST) project....... to review specialty guidelines and ascertain if HIV was discussed and testing recommended. METHODS: UK and European HIV testing guidelines were reviewed to produce a list of 25 ADCs and 49 ICs. UK guidelines for these conditions were identified from searches of the websites of specialist societies...

  20. Specialty pharmaceuticals: policy initiatives to improve assessment, pricing, prescription, and use.

    Science.gov (United States)

    Robinson, James C; Howell, Scott

    2014-10-01

    The value of "specialty pharmaceuticals" for cancer and other complex conditions depends not merely on their molecular structures but also on the manner in which the drugs are assessed, insured, priced, prescribed, and used. This article analyzes the five principal stages through which a specialty drug must pass on its journey from the laboratory to the bedside. These include regulatory approval by the Food and Drug Administration for market access, insurance coverage, pricing and payment, physician prescription, and patient engagement. If structured appropriately, each stage improves performance and supports continued research and development. If structured inappropriately, however, each stage adds to administrative burdens, distorts clinical decision making, and weakens incentives for innovation. Cautious optimism is in order, but neither the continued development of breakthrough products nor their use according to evidence-based guidelines can be taken for granted. Project HOPE—The People-to-People Health Foundation, Inc.

  1. A Delphi developed syllabus for the medical specialty of sport and exercise medicine.

    Science.gov (United States)

    Humphries, David; Jaques, Rod; Dijkstra, Hendrik Paulus

    2018-04-01

    Training in the medical specialty of sport and exercise medicine is now available in many, but not all countries. Lack of resources may be a barrier to the development of this important specialty field and the International Syllabus in Sport and Exercise Medicine Group was convened to reduce one potential barrier, the need to develop a syllabus. The group is composed of 17 sport and exercise medicine specialists residing in 12 countries (Australia, Canada, India, Ireland, Malaysia, the Netherlands, Qatar, South Africa, Sweden, Switzerland, the UK and USA). This paper presents the first phase of this project covering the domains and general learning areas of a specialist training syllabus in sport and exercise medicine. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  2. Specialty resident perceptions of the impact of a distributed education model on practice location intentions.

    Science.gov (United States)

    Myhre, Douglas L; Adamiak, Paul J; Pedersen, Jeanette S

    2015-01-01

    There is an increased focus internationally on the social mandate of postgraduate training programs. This study explores specialty residents' perceptions of the impact of the University of Calgary's (UC) distributed education rotations on their self-perceived likelihood of practice location, and if this effect is influenced by resident specialty or stage of program. Residents participating in the UC Distributed Royal College Initiative (DistRCI) between July 2010 and June 2013 completed an online survey following their rotation. Descriptive statistics and student's t-test were employed to analyze quantitative survey data, and a constant comparative approach was used to analyze free text qualitative responses. Residents indicated they were satisfied with the program (92%), and that the distributed rotations significantly increased their self-reported likelihood of practicing in smaller centers (p education program in contributing to future practice and career development, and its relevance in the social accountability of postgraduate programs.

  3. The role of emergency medicine physicians in trauma care in North America: evolution of a specialty

    Directory of Open Access Journals (Sweden)

    Grossman Michael D

    2009-08-01

    Full Text Available Abstract The role of Emergency Medicine Physicians (EMP in the care of trauma patients in North America has evolved since the advent of the specialty in the late 1980's. The evolution of this role in the context of the overall demands of the specialty and accreditation requirements of North American trauma centers will be discussed. Limited available data published in the literature examining the role of EMP's in trauma care will be reviewed with respect to its implications for an expanded role for EMPs in trauma care. Two training models currently in the early stages of development have been proposed to address needs for increased manpower in trauma and the critical care of trauma patients. The available information regarding these models will be reviewed along with the implications for improving the care of trauma patients in both Europe and North America.

  4. Investigation on the learning interest of senior undergraduate students in optoelectronics specialty

    Science.gov (United States)

    Wu, Shenjiang; Wang, Na; Li, Dangjuan; Liu, Chanlao

    2017-08-01

    With the increasing number of the graduate students, many of them have some troubles in job finding. This situation make a huge pressure on the senior students and loss them the interesting in study. This work investigate the reasons by questionnaire survey, panel discussion, interview, etc. to achieve the factors influence their learning interesting. The main reason of students do not have the motivation on study is that they do not understand the development and competition of photoelectric specialty, lack of innovation and entrepreneurship training, hysteresis of the learning knowledge and practical application. Finally, the paper gives some suggestions through teaching reform on how to improve students' learning enthusiasm. This work will contribute to the teaching and training of senior undergraduate students of optoelectronics specialty.

  5. Best practices across surgical specialties relating to simulation-based training.

    Science.gov (United States)

    Gardner, Aimee K; Scott, Daniel J; Pedowitz, Robert A; Sweet, Robert M; Feins, Richard H; Deutsch, Ellen S; Sachdeva, Ajit K

    2015-11-01

    Simulation-based training is playing an increasingly important role in surgery. However, there is insufficient discussion among the surgical specialties regarding how simulation may best be leveraged for training. There is much to be learned from one another as we all strive to meet new requirements within the context of Undergraduate Medical Education, Graduate Medical Education, and Continuing Medical Education. To address this need, a panel was convened at the 6th Annual Meeting of the Consortium of the American College of Surgeons-Accredited Education Institutes consisting of key leaders in the field of simulation from 4 surgical subspecialties, namely, general surgery, orthopedic surgery, cardiothoracic surgery, urology, and otolaryngology. An overview of how the 5 surgical specialties are using simulation-based training to meet a wide array of educational needs for all levels of learners is presented. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Beyond yields: Climate change effects on specialty crop quality and agroecological management

    Directory of Open Access Journals (Sweden)

    Selena Ahmed

    2016-03-01

    Full Text Available Abstract Climate change is impacting the sustainability of food systems through shifts in natural and human dimensions of agroecosystems that influence farmer livelihoods, consumer choices, and food security. This paper highlights the need for climate studies on specialty crops to focus not only on yields, but also on quality, as well as the ability of agroecological management to buffer climate effects on quality parameters. Crop quality refers to phytonutrient and secondary metabolite profiles and associated health and sensory properties that influence consumer buying decisions. Through two literature reviews, we provide examples of specialty crops that are vulnerable to climate effects on quality and examples of climate-resilient agroecological strategies. A range of specialty crops including fruits, vegetables, tree nuts, stimulants, and herbs were identified to respond to climate variables with changes in quality. The review on climate-resilient strategies to mitigate effects on crop quality highlighted a major gap in the literature. However, agricultural diversification emerged as a promising strategy for climate resilience more broadly and highlights the need for future research to assess the potential of diversified agroecosystems to buffer climate effects on crop quality. We integrate the concepts from our literature review within a socio-ecological systems framework that takes into account feedbacks between crop quality, consumer responses, and agroecosystem management. The presented framework is especially useful for two themes in agricultural development and marketing, nutrition-sensitive agriculture and terroir, for informing the design of climate-change resilient specialty crop systems focused on management of quality and other ecosystem services towards promoting environmental and human wellbeing.

  7. About training of Kazakh students of not language specialties basis of scientific speech

    OpenAIRE

    Ospanova D.

    2016-01-01

    The article discusses the process of written scientific speech training should include two components: teaching understanding and evaluating texts that make the scientific speech in all its substantive and problematic species and learning the rules of creating texts in the chosen specialty. The idea about functional languages develops in the theory vernaculars among which numerous languages of science take essentially important place; studying of these languages represents the theory and prac...

  8. Investigation of Science Faculty with Education Specialties within the Largest University System in the United States

    OpenAIRE

    Bush, Seth D; Pelaez, Nancy; Rudd, James A, II; Stevens, Michael T; Tanner, Kimberly D; Williams, Kathy, PhD

    2011-01-01

    Efforts to improve science education include university science departments hiring Science Faculty with Education Specialties (SFES), scientists who take on specialized roles in science education within their discipline. Although these positions have existed for decades and may be growing more common, few reports have investigated the SFES approach to improving science education. We present comprehensive data on the SFES in the California State University (CSU) system, the largest university ...

  9. VOCATIONAL AND PATRIOTIC EDUCATION OF STUDENTS OF DEFENSE SPECIALTIES AT A TECHNICAL UNIVERSITY

    Directory of Open Access Journals (Sweden)

    N. P. Ustinova

    2016-01-01

    Full Text Available The aim of the publication is an experimental research of patriotic qualities of students – future engineers of the defense industry. Methods. The study is conducted with the use of system-based analysis methods, teacher modeling, observation, interviews, pedagogical testing, and questionnaires. Diagnosis and evaluation of personal qualities of students are carried out using morphological life values test (modified by I. G. Senin, and questionnaire «The need for achieving the goal» (modified by Y. M. Orlov. The reliability of the results is granted by the use of statistical processing of empirical methods. Results. The average empirical values have been obtained concerning the level of professional and patriotic education of students of defence specialties at technical universities. It has been shown that targeted educational activities carried out on the basis of the identified organizational and pedagogical conditions, contributes to the level of professional and patriotic education of students of defense specialties at a Technical University.Scientific novelty. In relation to students – future professionals of defense industry, the concept of «professional – patriotic education» is clarified, which appears to be an integrative quality of a person, including cognitive, emotion-andvalue component and rational-activity components. The organizational and pedagogical conditions of vocational patriotic education of students of defense specialties are identified; the conditions are united into two groups: the creation of professional-oriented educative environment and creating the opportunities for active participation of students in educational and professional activities. Practical significance. Designed criterion-evaluation units are used to evaluate the current level of professional and patriotic education of students. Identified set of organizational and pedagogical conditions has been implemented in the process of patriotic education

  10. Publication trends of research articles from infectious diseases specialty in a medical journal from India

    Directory of Open Access Journals (Sweden)

    KVS Hari Kumar

    2012-01-01

    Full Text Available Background: Details about research productivity in the infectious diseases specialty from India are lacking. Objective: To analyse publishing trends and research productivity of articles related to infectious diseases in the Journal of the Association of Physicians of India (JAPI. Materials and Methods : We carried out bibliometric analysis of articles related to infectious diseases specialty from JAPI published between 2000 and 2011. Data were derived from the journal′s website and the articles were analysed for type (original article, case reports, etc., microorganism (bacterial, viral, etc. place of the research and timelines for publication. Results : Out of 2977 articles published in JAPI over last 12 years, 256 articles belong to infectious diseases subspecialty. Infectious diseases contributed 11-18% of the published articles per year in JAPI during the last decade. Original articles (31%, case reports (38% and correspondence (22% constitute the majority of article types, while remaining 9% was made up by images. Bacterial (22%, protozoal and helminthic (20%, HIV (15% and mycobacterial (16% diseases lead the type of microorganisms represented in the research articles. Mumbai (16%, Delhi (9% and Kolkata (7% are the top three places contributing to the articles, followed by Chandigarh and Chennai. Original articles and case reports took approximately 14 months for publication, as compared to 6 months for an image (P < 0.0001. Conclusion : Infectious diseases specialty contributes about 15% of articles per annum in JAPI. HIV and tuberculosis together account for 30% of published litearture with fair representation from other organisms. Mumbai and Delhi are the leading contributors towards research productivity in this specialty.

  11. Information Security: A Scientometric Study of the Profile, Structure, and Dynamics of an Emerging Scholarly Specialty

    Science.gov (United States)

    2014-03-01

    analysis to study biotechnology research and development. Co-classification, according to McCain, relies on the interpretation of subject analysts...difficulties when mapping higher levels entities (e.g., specialties). Chen and Guan (2011) argued that nanotechnology, biotechnology , and pharmaceuticals... Magazine Communications of the ACM 56 (6): 48-53. Georgi, Christoph, Inga-Lena Darkow, and Herbert Kotzab. 2010. “The Intellectual Foundation of the

  12. Detecting clinically relevant new information in clinical notes across specialties and settings.

    Science.gov (United States)

    Zhang, Rui; Pakhomov, Serguei V S; Arsoniadis, Elliot G; Lee, Janet T; Wang, Yan; Melton, Genevieve B

    2017-07-05

    Automated methods for identifying clinically relevant new versus redundant information in electronic health record (EHR) clinical notes is useful for clinicians and researchers involved in patient care and clinical research, respectively. We evaluated methods to automatically identify clinically relevant new information in clinical notes, and compared the quantity of redundant information across specialties and clinical settings. Statistical language models augmented with semantic similarity measures were evaluated as a means to detect and quantify clinically relevant new and redundant information over longitudinal clinical notes for a given patient. A corpus of 591 progress notes over 40 inpatient admissions was annotated for new information longitudinally by physicians to generate a reference standard. Note redundancy between various specialties was evaluated on 71,021 outpatient notes and 64,695 inpatient notes from 500 solid organ transplant patients (April 2015 through August 2015). Our best method achieved at best performance of 0.87 recall, 0.62 precision, and 0.72 F-measure. Addition of semantic similarity metrics compared to baseline improved recall but otherwise resulted in similar performance. While outpatient and inpatient notes had relatively similar levels of high redundancy (61% and 68%, respectively), redundancy differed by author specialty with mean redundancy of 75%, 66%, 57%, and 55% observed in pediatric, internal medicine, psychiatry and surgical notes, respectively. Automated techniques with statistical language models for detecting redundant versus clinically relevant new information in clinical notes do not improve with the addition of semantic similarity measures. While levels of redundancy seem relatively similar in the inpatient and ambulatory settings in the Fairview Health Services, clinical note redundancy appears to vary significantly with different medical specialties.

  13. The educational impact of the Specialty Care Access Network-Extension of Community Healthcare Outcomes program.

    Science.gov (United States)

    Salgia, Reena J; Mullan, Patricia B; McCurdy, Heather; Sales, Anne; Moseley, Richard H; Su, Grace L

    2014-11-01

    With the aging hepatitis C cohort and increasing prevalence of fatty liver disease, the burden on primary care providers (PCPs) to care for patients with liver disease is growing. In response, the Veterans Administration implemented initiatives for primary care-specialty referral to increase PCP competency in complex disease management. The Specialty Care Access Network-Extension of Community Healthcare Outcomes (SCAN-ECHO) program initiative was designed to transfer subspecialty knowledge to PCPs through case-based distance learning combined with real-time consultation. There is limited information regarding the initiative's ability to engage PCPs to learn and influence their practice. We surveyed PCPs to determine the factors that led to their participation in this program and the educational impact of participation. Of 51 potential participants, 24 responded to an anonymous survey. More than 75% of respondents participated more than one time in a SCAN-ECHO clinic. Providers were motivated to participate by a desire to learn more about liver disease, to apply the knowledge gained to future patients, and to save their patients time traveling to another center for specialty consultation. Seventy-one percent responded that the didactic component and case-based discussion were equally important. It is important that participation changed clinical practice: 75% of providers indicated they had personally discussed the information they learned from the case presentations with their colleague(s), and 42% indicated they helped a colleague care for their patient with the knowledge learned during discussions of other participants' cases. This study shows that the SCAN-ECHO videoconferencing program between PCPs and specialists can educate providers in the delivery of specialty care from a distance and potentially improve healthcare delivery.

  14. Specialty Training's Organizational Readiness for curriculum Change (STORC): development of a questionnaire in a Delphi study.

    Science.gov (United States)

    Bank, Lindsay; Jippes, Mariëlle; van Luijk, Scheltus; den Rooyen, Corry; Scherpbier, Albert; Scheele, Fedde

    2015-08-05

    In postgraduate medical education (PGME), programs have been restructured according to competency-based frameworks. The scale and implications of these adjustments justify a comprehensive implementation plan. Organizational Readiness for Change (ORC) is seen as a critical precursor for a successful implementation of change initiatives. Though, ORC in health care settings is mostly assessed in small scale settings and in relation to new policies and practices rather than educational change. Therefore our aim with this work was to develop an instrument to asses Specialty Training's Organizational Readiness for curriculum Change (STORC). A Delphi procedure was conducted to examine the applicability of a preliminary questionnaire in PGME, which was based on existing instruments designed for business and health care organizations. The 41 panellists (19 trainees and 22 supervisors from 6 specialties) from four different countries who were confronted with an apparent curriculum change, or would be in the near future, were asked to rate the relevance of a 89-item web-based questionnaire with regard to changes in specialty training on a 5-point Likert scale. Furthermore, they were invited to make qualitative comments on the items. In two rounds the 89-item preliminary questionnaire was reduced to 44 items. Items were either removed, kept, adapted or added based on individual item scores and qualitative comments. In the absence of a gold standard, this Delphi procedure was considered complete when the overall questionnaire rating exceeded 4.0 (scale 0-5). The overall item score reached 4.1 in the second round, meeting our criteria for completion of this Delphi procedure. This Delphi study describes the initial validating step in the development of an instrument to asses Specialty Training's Organisational Readiness for curriculum Change (STORC). Since ORC is measured on various subscales and presented as such, its strength lies in analysing these subscales. The latter makes

  15. E-cigarette specialty retailers: Data to assess the association between retail environment and student e-cigarette use

    OpenAIRE

    Georgiana Bostean; Catherine M. Crespi; Patsornkarn Vorapharuek; William J. McCarthy

    2017-01-01

    The retail environment is a major social determinant of health, yet little is known about the e-cigarette specialty retailer environment. The e-cigarette specialty retail environment may be associated with e-cigarette use by middle and high school students, an issue that was addressed in a recent article entitled, ?E-cigarette use among students and e-cigarette specialty retailer presence near schools,? by Bostean and colleagues (G. Bostean, C.M. Crespi, P. Vorapharuek, W.J. McCarthy, 2016 [1...

  16. Global warning, global warming

    International Nuclear Information System (INIS)

    Benarde, M.A.

    1992-01-01

    This book provides insights into the formidable array of issues which, in a warmer world, could impinge upon every facet of readers lives. It examines climatic change and long-term implications of global warming for the ecosystem. Topics include the ozone layer and how it works; the greenhouse effect; the dangers of imbalance and its effects on human and animal life; disruptions to the basic ecology of the planet; and the real scientific evidence for and against aberrant climatic shifts. The author also examines workable social and political programs and changes that must be instituted to avoid ecological disaster

  17. [Prosthodontic specialty training in the United States: what can we learn].

    Science.gov (United States)

    Qing, H

    2017-12-09

    Prosthodontics is one of the nine recognized specialties by American Dental Association. The postgraduate prosthodontic program used to train prosthodontic specialists in U S A started about 70 years ago. Compared to China which just launched the dental residency programs, the programs in U S A have more developed and relatively more mature education system. It is worthwhile for China to study and learn the U S A prosthodontic residency education program. Prosthodontics is a specialty to diagnose and treat complex dental problems, and is often considered as the 'orchestrator' directing and coordinating all the other dental specialists to manage complex situations. This specialty plays an important role in a nation's oral health system. The present article is aimed to introduce the history of US prosthodontic residency program, initial accreditation, curriculum, education standards and mechanisms of the residency program, and how the program is monitored and managed post initial accreditation, with the hope that this system can serve as a reference for China's developing its own residency program.

  18. Specialty Practice and Cost Considerations in the Management of Uveitis Associated With Juvenile Idiopathic Arthritis.

    Science.gov (United States)

    Palestine, Alan G; Singh, Jasleen K; Kolfenbach, Jason R; Ozzello, Daniel J

    2016-07-01

    To evaluate whether cost, prior insurance authorization concerns, and subspecialty practice influence therapeutic decisions in the treatment of uveitis associated with juvenile idiopathic arthritis. A total of 2,965 pediatric ophthalmologists, uveitis specialists, retina specialists, and rheumatologists across the United States were surveyed via e-mail regarding their choice in long-term therapy for a hypothetical patient with uveitis associated with juvenile idiopathic arthritis. Outcomes of interest were differences in therapy choice based on cost/prior authorization and specialty practice. There were significant differences in the use of methotrexate and biologics among specialists, both with and without consideration for cost and prior authorization. Physicians in four different specialties who treat uveitis associated with juvenile idiopathic arthritis agree on methotrexate as a first-line treatment choice and a biologic immunosuppressive medication as a second choice, but there are significant differences between the specialties in their use of these medications. Cost and insurance considerations did not affect therapy selection. [J Pediatr Ophthalmol Strabismus. 2016;53(4):246-251.]. Copyright 2016, SLACK Incorporated.

  19. Expanding Educators' Contributions to Continuous Quality Improvement of American Board of Medical Specialties Maintenance of Certification.

    Science.gov (United States)

    Nora, Lois Margaret; Pouwels, Mellie Villahermosa; Irons, Mira

    2016-01-01

    The American Board of Medical Specialties board certification has transformed into a career-long process of learning, assessment, and performance improvement through its Program for Maintenance of Certification (MOC). Medical educators across many medical professional organizations, specialty societies, and other institutions have played important roles in shaping MOC and tailoring its overarching framework to the needs of different specialties. This Commentary addresses potential barriers to engagement in work related to MOC for medical school (MS) and academic health center (AHC) educators and identifies reasons for, and ways to accomplish, greater involvement in this work. The authors present ways that medical and other health professions educators in these settings can contribute to the continuous improvement of the MOC program including developing educational and assessment activities, engaging in debate about MOC, linking MOC with institutional quality improvement activities, and pursuing MOC-related scholarship. MS- and AHC-based educators have much to offer this still-young and continually improving program, and their engagement is sought, necessary, and welcomed.

  20. Gender in clinical neuropsychology: practice survey trends and comparisons outside the specialty.

    Science.gov (United States)

    Sweet, Jerry J; Lee, Catherine; Guidotti Breting, Leslie M; Benson, Laura M

    2018-02-01

    This paper describes gender-related trends within clinical neuropsychology, based primarily on recurrent practice surveys within the specialty and, to a lesser extent, job-related information from medical specialties and the general U.S. labor market. Chronological and cross-sectional analyses of professional practice survey data from 2005, 2010, and 2015 relevant to gender. As is common with survey data, descriptive analysis and independent samples t-tests were conducted. Longitudinal data allowed for examination of gender trends, as well as observations of change and stability of factors associated with gender, over time. Women have become dominant in number in clinical neuropsychology, and also comprise a vast majority of practitioners entering the specialty. Gender differences are noted in professional identity, work status, work settings, types of career satisfaction, and retirement expectations. Women are more likely to identify work environment and personal/family obstacles to aspects of career satisfaction. A gender pay gap was found at all time points and is not narrowing. As is true nationally, multiple factors appear related to the gender pay gap in clinical neuropsychology. Women in neuropsychology are now dominant in number, and their presence is strongly associated with specific practice patterns, such as greater institutional employment, less involvement in forensic practice, and strong involvement in pediatric practice, which may be maintaining the sizeable gender pay gap in neuropsychology. As the proportion of women neuropsychologists continues to increase, flexible work hours, and alternative means of remuneration may be needed to offset current disproportionate family-related responsibilities.

  1. Mapping Direct Observations From Objective Structured Clinical Examinations to the Milestones Across Specialties.

    Science.gov (United States)

    Baker-Genaw, Kimberly; Kokas, Maria S; Ahsan, Syed F; Darnley-Fisch, Deborah; Drake, Sean; Goyal, Nikhil; Inamdar, Kedar; Moutzouros, Vasilios; Prabhakar, Deepak; Rolland, Laurie; Sangha, Roopina; Shreve, Maria; Woodward, Ann

    2016-07-01

    Little is known about residents' performance on the milestones at the institutional level. Our institution formed a work group to explore this using an institutional-level curriculum and residents' evaluation of the milestones. We assessed whether beginner-level milestones for interpersonal and communication skills (ICS) related to observable behaviors in ICS-focused objective structured clinical examinations (OSCEs) for postgraduate year (PGY) 1 residents across specialties. The work group compared ICS subcompetencies across 12 programs to identify common beginner-level physician-patient communication milestones. The selected ICS milestone sets were compared for common language with the ICS-OSCE assessment tool-the Kalamazoo Essential Elements of Communication Checklist-Adapted (KEECC-A). To assess whether OSCE scores related to ICS milestone scores, all PGY-1 residents from programs that were part of Next Accreditation System Phase 1 were identified; their OSCE scores from July 2013 to June 2014 and ICS subcompetency scores from December 2014 were compared. The milestones for 10 specialties and the transitional year had at least 1 ICS subcompetency that related to physician-patient communication. The language of the ICS beginner-level milestones appears similar to behaviors outlined in the KEECC-A. All 60 residents with complete data received at least a beginner-level ICS subcompetency score and at least a satisfactory score on all 3 OSCEs. The ICS-OSCE scores for PGY-1 residents appear to relate to beginner-level milestones for physician-patient communication across multiple specialties.

  2. Specialty glass development for radiation shielding windows and nuclear waste immobilization

    International Nuclear Information System (INIS)

    Mandal, S.; Ghorui, S.; Roy Chowdhury, A.; Sen, R.; Chakraborty, A.K.; Sen, S.; Maiti, H.S.

    2015-01-01

    The technology of two important varieties of specialty glasses, namely high density Radiation Shielding Window (RSW) glass and specialty glass beads of borosilicate composition have been successfully developed in CGCRI with an aim to meet the countries requirement. Radiation Shielding Windows used in nuclear installations, are viewing devices, which allow direct viewing into radioactive areas while still providing adequate protection to the operating personnel. The glass blocks are stabilized against damage from radiation by introducing cerium in definite proportions. Considering the essentially of developing an indigenous technology to make the country self-sufficient for this critical item, CGCRI has taken up a major programme to develop high lead containing glasses required for RSWs under a MoD with BARC. On the other hand, the specialty glass bead of specific composition and properties is a critical material required for management of radioactive waste in a closed nuclear fuel cycle that is followed by India. During reprocessing of the spent nuclear fuel, high level radio-active liquid waste (HLW) is produced containing unwanted radio isotopes some of which remain radioactive for thousands of years. The need is to immobilize them within a molecular structure so that they will not come out and be released to the ambience and thereby needs to be resolved if nuclear power is to make a significant contribution to the country's power requirement. Borosilicate glass has emerged as the material of choice for immobilization due to its unique random network structure

  3. Operational experience with DICOM for the clinical specialties in the healthcare enterprise

    Science.gov (United States)

    Kuzmak, Peter M.; Dayhoff, Ruth E.

    2004-04-01

    A number of clinical specialties routinely use images in treating patients, for example ophthalmology, dentistry, cardiology, endoscopy, and surgery. These images are captured by a variety of commercial digital image acquisition systems. The US Department of Veterans Affairs has been working for several years on advancing the use of the Digital Imaging and Communications in Medicine (DICOM) Standard in these clinical specialties. This is an effort that has involved several facets: (1) working with the vendors to ensure that they satisfy existing DICOM requirements, (2) developing interface software to the VistA hospital information system (HIS), (3) field testing DICOM systems, (4) deploying these DICOM interfaces nation-wide to all VA medical centers, (5) working with the healthcare providers using the system, and (6) participating in the DICOM working groups to improve the standard. The VA is now beginning to develop clinical applications that make use of the DICOM interfaces in the clinical specialties. The first of these will be in ophthalmology to remotely screen patients for diabetic retinopathy.

  4. Estimated cost savings associated with the transfer of office-administered specialty pharmaceuticals to a specialty pharmacy provider in a Medical Injectable Drug program.

    Science.gov (United States)

    Baldini, Christopher G; Culley, Eric J

    2011-01-01

    A large managed care organization (MCO) in western Pennsylvania initiated a Medical Injectable Drug (MID) program in 2002 that transferred a specific subset of specialty drugs from physician reimbursement under the traditional "buy-and-bill" model in the medical benefit to MCO purchase from a specialty pharmacy provider (SPP) that supplied physician offices with the MIDs. The MID program was initiated with 4 drugs in 2002 (palivizumab and 3 hyaluronate products/derivatives) growing to more than 50 drugs by 2007-2008. To (a) describe the MID program as a method to manage the cost and delivery of this subset of specialty drugs, and (b) estimate the MID program cost savings in 2007 and 2008 in an MCO with approximately 4.6 million members. Cost savings generated by the MID program were calculated by comparing the total actual expenditure (plan cost plus member cost) on medications included in the MID program for calendar years 2007 and 2008 with the total estimated expenditure that would have been paid to physicians during the same time period for the same medication if reimbursement had been made using HCPCS (J code) billing under the physician "buy-and-bill" reimbursement rates. For the approximately 50 drugs in the MID program in 2007 and 2008, the drug cost savings in 2007 were estimated to be $15.5 million (18.2%) or $290 per claim ($0.28 per member per month [PMPM]) and about $13 million (12.7%) or $201 per claim ($0.23 PMPM) in 2008. Although 28% of MID claims continued to be billed by physicians using J codes in 2007 and 22% in 2008, all claims for MIDs were limited to the SPP reimbursement rates. This MID program was associated with health plan cost savings of approximately $28.5 million over 2 years, achieved by the transfer of about 50 physician-administered injectable pharmaceuticals from reimbursement to physicians to reimbursement to a single SPP and payment of physician claims for MIDs at the SPP reimbursement rates.

  5. Specialty magnets

    International Nuclear Information System (INIS)

    Halbach, K.

    1986-07-01

    A number of basic conceptual designs are explained for magnet systems that use permanent magnet materials. Included are iron free multipoles and hybrid magnets. Also appended is a discussion of the manufacturing process and magnetic properties of some permanent magnet materials

  6. Against Globalization

    DEFF Research Database (Denmark)

    Philipsen, Lotte; Baggesgaard, Mads Anders

    2013-01-01

    In order to understand globalization, we need to consider what globalization is not. That is, in order to understand the mechanisms and elements that work toward globalization, we must, in a sense, read against globalization, highlighting the limitations of the concept and its inherent conflicts....... Only by employing this as a critical practice will we be analytically able to gain a dynamic understanding of the forces of globalization as they unfold today and as they have developed historically....

  7. Contingent Valuation Analysis of an Otolaryngology and Ophthalmology Emergency Department: The Value of Acute Specialty Care.

    Science.gov (United States)

    Naunheim, Matthew R; Kozin, Elliot D; Sethi, Rosh K; Ota, H G; Gray, Stacey T; Shrime, Mark G

    2017-03-01

    Specialty emergency departments (EDs) provide a unique mechanism of health care delivery, but the value that they add to the medical system is not known. Evaluation of patient preferences to determine value can have a direct impact on resource allocation and direct-to-specialist care. To assess the feasibility of contingent valuation (CV) methodology using a willingness-to-pay (WTP) survey to evaluate specialty emergency services, in the context of an ophthalmology- and otolaryngology-specific ED. Contingent valuation analysis of a standalone otolaryngology and ophthalmology ED. Participants were English-speaking adults presenting to a dedicated otolaryngology and ophthalmology ED. The WTP questions were assessed using a payment card format, with reference to an alternative modality of treatment (ie, general ED), and were analyzed with multivariate regression. Validated WTP survey administered from October 14, 2014, through October 1, 2015. Sociodemographic data, level of distress, referral data, income, and WTP. A total of 327 of 423 (77.3%) ED patients responded to the WTP survey, with 116 ophthalmology and 211 otolaryngology patients included (52.3% female; mean [range] age, 46 [18-90] years). The most common reason for seeking care at this facility was a reputation for specialty care for both ear, nose, and throat (80 [37.9%]) and ophthalmology (43 [37.1%]). Mean WTP for specialty-specific ED services was $377 for ophthalmology patients, and $321 for otolaryngology patients ($340 overall; 95% CI, $294 to $386), without significant difference between groups (absolute difference, $56; 95% CI, $-156 to $43). Self-reported level of distress was higher among ear, nose, and throat vs ophthalmology patients (absolute difference, 0.47 on a Likert scale of 1-7; 95% CI, 0.10 to 0.84). Neither level of distress, income, nor demographic characteristics influenced WTP, but patients with higher estimates of total visit cost were more likely to have higher WTP (β coefficient

  8. Emergency Contraception: A multi-specialty survey of clinician knowledge and practices

    Science.gov (United States)

    Batur, Pelin; Cleland, Kelly; McNamara, Megan; Wu, Justine; Pickle, Sarah

    2015-01-01

    Objectives To assess knowledge and provision of emergency contraception (EC), particularly the most effective methods. Study Design A web-based survey was distributed to a cross-sectional convenience sample of healthcare providers across specialties treating reproductive-aged women. The survey was sent to 3,260 practicing physicians and advanced practice clinicians in 14 academic centers between February 2013 and April 2014. We analyzed responses by provider specialty using multivariable logistic regression. Results The final sample included 1,684 providers (response rate = 51.7%). Ninety-five percent of the respondents had heard of levonorgestrel (LNG) EC. Among reproductive health specialists, 81% provide levonorgestrel EC in their practice, although only half (52%) had heard of ulipristal acetate (UPA) and very few provide it (14%). The majority in family medicine (69%) and emergency medicine (74%) provide levonorgestrel, in contrast to 42% of internists and 55% of pediatricians. However, the more effective methods (UPA and copper IUD) were little known and rarely provided outside of reproductive health specialties; 18% of internists and 14% of emergency medicine providers had heard of UPA and 4% provide it. Only 22% of emergency providers and 32% of pediatricians had heard of the copper IUD used as EC. Among reproductive health specialists, only 36% provide copper IUD as EC in their practice. Specialty, provider type and proportion of women of reproductive age in the practice were related to knowledge and provision of some forms of EC. Conclusions Awareness and provision of the most effective EC methods, UPA and the copper IUD (which are provider-dependent), are substantially lower than for LNG EC, especially among providers who do not focus on reproductive health. Implications In our sample of 1,684 healthcare providers from diverse specialties who treat reproductive-aged women, knowledge and provision of the most effective forms of emergency contraception

  9. Summary of the National Institute of Child Health and Human Development-best pharmaceuticals for Children Act Pediatric Formulation Initiatives Workshop-Pediatric Biopharmaceutics Classification System Working Group.

    Science.gov (United States)

    Abdel-Rahman, Susan M; Amidon, Gordon L; Kaul, Ajay; Lukacova, Viera; Vinks, Alexander A; Knipp, Gregory T

    2012-11-01

    The Biopharmaceutics Classification System (BCS) allows compounds to be classified based on their in vitro solubility and intestinal permeability. The BCS has found widespread use in the pharmaceutical community to be an enabling guide for the rational selection of compounds, formulation for clinical advancement, and generic biowaivers. The Pediatric Biopharmaceutics Classification System (PBCS) Working Group was convened to consider the possibility of developing an analogous pediatric-based classification system. Because there are distinct developmental differences that can alter intestinal contents, volumes, permeability, and potentially biorelevant solubilities at different ages, the PBCS Working Group focused on identifying age-specific issues that need to be considered in establishing a flexible, yet rigorous PBCS. We summarized the findings of the PBCS Working Group and provided insights into considerations required for the development of a PBCS. Through several meetings conducted both at The Eunice Kennedy Shriver National Institute of Child Health, Human Development-US Pediatric Formulation Initiative Workshop (November 2011) and via teleconferences, the PBCS Working Group considered several high-level questions that were raised to frame the classification system. In addition, the PBCS Working Group identified a number of knowledge gaps that need to be addressed to develop a rigorous PBCS. It was determined that for a PBCS to be truly meaningful, it needs to be broken down into several different age groups that account for developmental changes in intestinal permeability, luminal contents, and gastrointestinal (GI) transit. Several critical knowledge gaps were identified, including (1) a lack of fully understanding the ontogeny of drug metabolizing enzymes and transporters along the GI tract, in the liver, and in the kidney; (2) an incomplete understanding of age-based changes in the GI, liver, and kidney physiology; (3) a clear need to better understand

  10. 78 FR 44922 - Vegetable and Specialty Crop Marketing Orders; Notice of Request for Extension and Revision of a...

    Science.gov (United States)

    2013-07-25

    ... Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request... assured of consideration. Additional Information or Comments: Contact Andrew Hatch, Supervisory Marketing....regulations.gov . SUPPLEMENTARY INFORMATION: Title: Vegetable and Specialty Crop Marketing Orders. OMB Number...

  11. 6. Seminar of the IIE-ININ-IMP on technological specialties. Topic 10: industrial applications of radiation and control

    International Nuclear Information System (INIS)

    1992-01-01

    The document includes 7 papers presented at the 6. Seminar of the IIE-ININ-IMP (Mexico) on technological specialties in the field of industrial applications of radiation and control. (Topic 10). A separate abstract was prepared for each paper

  12. Survey results show that adults are willing to pay higher insurance premiums for generous coverage of specialty drugs.

    Science.gov (United States)

    Romley, John A; Sanchez, Yuri; Penrod, John R; Goldman, Dana P

    2012-04-01

    Generous coverage of specialty drugs for cancer and other diseases may be valuable not only for sick patients currently using these drugs, but also for healthy people who recognize the potential need for them in the future. This study estimated how healthy people value insurance coverage of specialty drugs, defined as high-cost drugs that treat cancer and other serious health conditions like multiple sclerosis, by quantifying willingness to pay via a survey. US adults were estimated to be willing to pay an extra $12.94 on average in insurance premiums per month for generous specialty-drug coverage--in effect, $2.58 for every dollar in out-of-pocket costs that they would expect to pay with a less generous insurance plan. Given the value that people assign to generous coverage of specialty drugs, having high cost sharing on these drugs seemingly runs contrary to what people value in their health insurance.

  13. Specialty pharmacies and other restricted drug distribution systems: financial and safety considerations for patients and health-system pharmacists.

    Science.gov (United States)

    Kirschenbaum, Bonnie E

    2009-12-15

    To discuss the role of restricted drug distribution systems in the implementation of risk evaluation and mitigation strategies (REMS), health-system pharmacists' concerns associated with the use of specialty pharmacies and other restricted drug distribution systems, reimbursement policies for high-cost specialty drugs, supply chain models for traditional and specialty drugs, and emerging trends in the management of and reimbursement for specialty pharmaceuticals. Restricted drug distribution systems established by pharmaceutical manufacturers, specialty pharmacies, or other specialty suppliers may be a component of REMS, which are required by the Food and Drug Administration for the management of known or potential serious risks from certain drugs. Concerns of health-system pharmacists using specialty suppliers include access to pharmaceuticals, operational challenges, product integrity, financial implications, continuity of care, and patient safety. An ambulatory care patient taking a specialty drug product from home to a hospital outpatient clinic or inpatient setting for administration, a practice known as "brown bagging," raises concerns about product integrity and institutional liability. An institution's finances, tolerance for liability, and ability to skillfully manage the processes involved often determine its choice between an approach that prohibits brown bagging but is costly and one that permits the practice under certain conditions and is less costly. The recent shift from a traditional supply chain model to a specialty pharmacy supply chain model for high-cost pharmaceuticals has the potential to increase pharmaceutical costs for health systems. A dialogue is needed between health-system pharmacists and group purchasing organizations to address the latter's role in mitigating the financial implications of this change and to help clarify the safety issues. Some health plans have shifted part of the cost of expensive drugs to patients by establishing a

  14. A Call to Action to Address Gender Equity Within Our Specialty: Time's Up on Waiting for Change.

    Science.gov (United States)

    Baecher-Lind, Laura; Abbott, Jodi; Atkins, Katharyn Meredith; Nijjar, J Biba; Royce, Celeste; Schiff, Lauren; Ricciotti, Hope A

    2018-06-01

    Although national attention has been focused on sexual harassment and gender inequity in the United States, leaders within the obstetrics and gynecology community have remained relatively silent. Sexual harassment and gender inequity remain pervasive in our specialty. This article serves as a call to action for leadership as well as physicians within obstetrics and gynecology to implement ethical and evidence-based approaches to reduce gender inequity and improve workplace culture within our specialty.

  15. [Impact of the Core Training Law on preventive medicine and public health training and other common medical specialties].

    Science.gov (United States)

    Latasa, Pello; Gil-Borrelli, Christian; Aguilera, José Antonio; Reques, Laura; Barreales, Saúl; Ojeda, Elena; Alemán, Guadalupe; Iniesta, Carlos; Gullón, Pedro

    2016-01-01

    The purpose of the Core Training Law (CTL) is to amend specialised medical training to include 24 months of common training. The aim of this study is to assess its potential impact on the Preventive Medicine and Public Health (PM&PH) training programme and other medical specialties. The programmes of the 21 common medical specialties were analysed and the recommended training periods for each specialty collected, before the information was agreed upon by three observers. The training impact was calculated as the percentage of months that should be amended per specialty to adapt to the common training schedule. The Preventive Medicine and Public Health training programme is the specialty most affected by the Core Training Law (100%, 24 months). Intensive medicine (0%, 0 months) and medical oncology (17%, 4 months) is the least affected. The CTL affects the common medical specialties in different ways and requires a complete reorganisation of the activities and competencies of PM&PH professionals. Copyright © 2016 SESPAS. Published by Elsevier Espana. All rights reserved.

  16. Global Strategy

    DEFF Research Database (Denmark)

    Li, Peter Ping

    2013-01-01

    Global strategy differs from domestic strategy in terms of content and process as well as context and structure. The content of global strategy can contain five key elements, while the process of global strategy can have six major stages. These are expounded below. Global strategy is influenced...... by rich and complementary local contexts with diverse resource pools and game rules at the national level to form a broad ecosystem at the global level. Further, global strategy dictates the interaction or balance between different entry strategies at the levels of internal and external networks....

  17. Preparation, in-vitro and in-vivo evaluation of spray-dried ternary solid dispersion of biopharmaceutics classification system class II model drug.

    Science.gov (United States)

    Paidi, Sharan K; Jena, Sunil K; Ahuja, Bhupesh K; Devasari, Naresh; Suresh, Sarasija

    2015-05-01

    The objective of this study was to investigate the impact of a novel spray-dried ternary solid dispersion (TSD) on the dissolution rate and bioavailability of a biopharmaceutics classification system (BCS) class II model drug, atorvastatin calcium trihydrate (ATC), and evaluate its in-vitro and in-vivo performance. TSD of ATC was prepared by spray-drying method employing ethanol/water solvent systems. The TSD formulations, composed of hydroxypropyl methylcellulose (HPMC E5) and nicotinamide, were optimized by rotatable central composite design. Physicochemical characterization along with dissolution, stability and pharmacokinetic study of optimized TSD was evaluated. The optimized TSD was found to be amorphous with spherical shape morphology. It exhibited a fourfold increase in dissolution rate in comparison to ATC, with a considerable enhancement in oral bioavailability (relative bioavailability of 134.11%). Physicochemical characterization and dissolution study of optimized TSD at the end of stability studies clearly indicated that the stability of optimized TSD was due to hydrogen bonding between drug and HPMC E5 and nicotinamide. This bonding remained unaffected even under stressful conditions of high temperature and humidity. The TSD exhibits a significant increase in dissolution rate, and for this reason should be useful as an efficacious tool to enhance the bioavailability of BCS class II drug molecule, ATC. © 2015 Royal Pharmaceutical Society.

  18. Evaluation of the use of partition coefficients and molecular surface properties as predictors of drug absorption: a provisional biopharmaceutical classification of the list of national essential medi

    Directory of Open Access Journals (Sweden)

    NU Rahman

    2011-05-01

    Full Text Available Background and the purpose of the study: Partition coefficients (log D and log P and molecular surface area (PSA are potential predictors of the intestinal permeability of drugs. The aim of this investigation was to evaluate and compare these intestinal permeability indicators.   Methods: Aqueous solubility data were obtained from literature or calculated using ACD/Labs and ALOGPS. Permeability data were predicted based on log P, log D at pH 6.0 (log D6.0, and PSA.  Results: Metoprolol's log P, log D6.0 and a PSA of <65 Å correctly predicted 55.9%, 50.8% and 54.2% of permeability classes, respectively. Labetalol's log P, log D6.0, and PSA correctly predicted 54.2%, 64.4% and 61% of permeability classes, respectively. Log D6.0 correlated well (81% with Caco-2 permeability (Papp. Of the list of national essential medicines, 135 orally administered drugs were classified into biopharmaceutical classification system (BCS. Of these, 57 (42.2%, 28 (20.7%, 44 (32.6%, and 6 (4.4% were class I, II, III and IV respectively. Conclusion: Log D6.0 showed better prediction capability than log P. Metoprolol as permeability internal standard was more conservative than labetalol.

  19. BIOPHARMACEUTICAL RESEARCHES IN VITRO ON THE CHOICE OF OPTIMAL COMPOSITION OF PHARMACEUTICAL AID FOR OINTMENT PRODUCTION BASED ON СО2 EXTRACT OF SCHISANDRA CHINENSIS SEEDS

    Directory of Open Access Journals (Sweden)

    Y. A. Morozov

    2014-01-01

    Full Text Available Schisandra chinensis is valuable species of herbal medicines raw materials (fruits, seeds, caruncles, leaves, stem cortex, and roots with root systems which are used for medicines and biologically active supplements production in food and cosmetic industry. However nowadays medicines from Schisandra chinensis are only represented by tincture for internal use on domestic pharmaceutical market. There are data about positive implementation of medicines based on raw materials of Schisandra chinensis as external medicine forms in folk medicine and in literature. The purpose of this work is the development of soft external medicine form – ointment based on СО2 extract of Schisandra chinensis seeds. Biopharmaceutical researches in vitro on the choice of optimal ointment composition by the method of dialysis through semi permeable membrane were conducted for this purpose. Release rate was calculated in relation to base biologically active substances of Schisandra chinensis – lignans (schizandrin and γ-schizandrin which determine its basic pharmacological value. Based on the results of the research conducted it is possible to conclude that the best ointment bases are hydrophilous “classic” poly ethylene oxide and oleogel based on paraffinic oil and aerosil.

  20. First Steps to Develop and Validate a CFPD Model in Order to Support the Design of Nose-to-Brain Delivered Biopharmaceuticals.

    Science.gov (United States)

    Engelhardt, Lucas; Röhm, Martina; Mavoungou, Chrystelle; Schindowski, Katharina; Schafmeister, Annette; Simon, Ulrich

    2016-06-01

    Aerosol particle deposition in the human nasal cavity is of high interest in particular for intranasal central nervous system (CNS) drug delivery via the olfactory cleft. The objective of this study was the development and comparison of a numerical and experimental model to investigate various parameters for olfactory particle deposition within the complex anatomical nasal geometry. Based on a standardized nasal cavity, a computational fluid and particle dynamics (CFPD) model was developed that enables the variation and optimization of different parameters, which were validated by in vitro experiments using a constructed rapid-prototyped human nose model. For various flow rates (5 to 40 l/min) and particle sizes (1 to 10 μm), the airflow velocities, the calculated particle airflow patterns and the particle deposition correlated very well with the experiment. Particle deposition was investigated numerically by varying particle sizes at constant flow rate and vice versa assuming the particle size distribution of the used nebulizer. The developed CFPD model could be directly translated to the in vitro results. Hence, it can be applied for parameter screening and will contribute to the improvement of aerosol particle deposition at the olfactory cleft for CNS drug delivery in particular for biopharmaceuticals.