Innovation strategies for generic drug companies: moving into supergenerics.

PubMed

Ross, Malcolm S F

2010-04-01

Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies.

Encouraging the use of generic medicines: implications for transition economies.

PubMed

King, Derek R; Kanavos, Panos

2002-08-01

Generic drugs have a key role to play in the efficient allocation of financial resources for pharmaceutical medicines. Policies implemented in the countries with a high rate of generic drug use, such as Canada, Denmark, Germany, the Netherlands, the United Kingdom, and the United States, are reviewed, with consideration of the market structures that facilitate strong competition. Savings in these countries are realized through increases in the volume of generic drugs used and the frequently significant differences in the price between generic medicines and branded originator medicines. Their policy tools include the mix of supply-side measures and demand-side measures that are relevant for generic promotion and higher generic use. On the supply-side, key policy measures include generic drug marketing regulation that facilitates market entry soon after patent expiration, reference pricing, the pricing of branded originator products, and the degree of price competition in pharmaceutical markets. On the demand-side, measures typically encompass influencing prescribing and dispensing patterns as well as introducing a co-payment structure for consumers/patients that takes into consideration the difference in cost between branded and generic medicines. Quality of generic medicines is a pre-condition for all other measures discussed to take effect. The paper concludes by offering a list of policy options for decision-makers in Central and Eastern European economies in transition.

Exploring community pharmacists' views on generic medicines: a nationwide study from Malaysia.

PubMed

Chong, Chee Ping; Hassali, Mohamed Azmi; Bahari, Mohd Baidi; Shafie, Asrul Akmal

2011-02-01

To evaluate the Malaysian community pharmacists' views on generic medicines. A sample of 1419 Malaysian community pharmacies with resident pharmacists. A cross-sectional nationwide survey using a self-completed mailing questionnaire. Pharmacists' views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence. Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia. The Malaysian pharmacists' have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.

Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.

PubMed

Borg, John Joseph; Tomasi, Paolo; Pani, Luca; Aislaitner, George; Pirozynski, Michal; Leufkens, Hubert; Melchiorri, Daniela

2014-01-01

When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioequivalence study), and safety data for the innovator. The extensive experience from bringing generic products to the market over the last decades allows the conclusion that they are well-accepted and provide a useful alternative option for cost-effective pharmacotherapy. While supporting this conclusion, there are a number of issues to be considered during the assessment of a generic product application. Six scenarios are described in total, from an efficacy and a safety perspective, where potential concerns with the current regulatory standards could arise in the approval of generic products. We also propose solutions to these scenarios in order to foster debate on these issues.

Generic Skills. Keys to Job Performance.

ERIC Educational Resources Information Center

Smith, Arthur De W.

The generic skills studies in Canada have as their objectives the formulation of generic skills, the identification of their uses for certain occupational groups, and the preparation of specifications for instructional modules in an attempt to provide greater flexibility to workers, employers, and vocational training programs. Another objective of…

Frameworks for evaluating health research capacity strengthening: a qualitative study

PubMed Central

2013-01-01

Background Health research capacity strengthening (RCS) projects are often complex and hard to evaluate. In order to inform health RCS evaluation efforts, we aimed to describe and compare key characteristics of existing health RCS evaluation frameworks: their process of development, purpose, target users, structure, content and coverage of important evaluation issues. A secondary objective was to explore what use had been made of the ESSENCE framework, which attempts to address one such issue: harmonising the evaluation requirements of different funders. Methods We identified and analysed health RCS evaluation frameworks published by seven funding agencies between 2004 and 2012, using a mixed methods approach involving structured qualitative analyses of documents, a stakeholder survey and consultations with key contacts in health RCS funding agencies. Results The frameworks were intended for use predominantly by the organisations themselves, and most were oriented primarily towards funders’ internal organisational performance requirements. The frameworks made limited reference to theories that specifically concern RCS. Generic devices, such as logical frameworks, were typically used to document activities, outputs and outcomes, but with little emphasis on exploring underlying assumptions or contextual constraints. Usage of the ESSENCE framework appeared limited. Conclusions We believe that there is scope for improving frameworks through the incorporation of more accessible information about how to do evaluation in practice; greater involvement of stakeholders, following evaluation capacity building principles; greater emphasis on explaining underlying rationales of frameworks; and structuring frameworks so that they separate generic and project-specific aspects of health RCS evaluation. The third and fourth of these improvements might assist harmonisation. PMID:24330628

76 FR 24925 - Solicitation for Public Comment on Potential Alternatives To Resolve Generic Safety Issue 191...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-03

... comment on potential alternatives for risk informing the path forward to resolve Generic Safety Issue (GSI... Notation Vote Paper (SECY-10-0113) which presented to the Commission the regulatory path forward options... the staff, in part, to explore alternative paths forward for resolving GSI-191. Discussion While GSI...

[It is not only about cost ... when it comes to generic medication].

PubMed

Piguet, Valérie; D'Incau, Stéphanie; Besson, Marie; Desmeules, Jules; Cedraschi, Christine

2016-06-22

The aim of this qualitative study was to explore patients' representations regarding generics in patients suffering from non-specific disabling chronic musculoskeletal pain, as these patients are confronted with the issue of the prescription and/or substitution of original formulations with generics. Patients' representations suggest that they might be confident in taking a generic medication: when the generic medication is prescribed by the physician and each prescription is discussed, i.e., the patient is prescribed the generic version of a given medication and not a generic medication. Economic arguments are not sufficient to accept substitution. Negative representations require attention and need be considered.

Key drivers for market penetration of biosimilars in Europe.

PubMed

Rémuzat, Cécile; Dorey, Julie; Cristeau, Olivier; Ionescu, Dan; Radière, Guerric; Toumi, Mondher

2017-01-01

Background & Objectives : Potential drivers and barriers of biosimilar uptake were mainly analysed through qualitative approaches. The study objective was to conduct a quantitative analysis and identify drivers of biosimilar uptake of all available biosimilars in the European Union (EU). Methods : A three-step process was established to identify key drivers for the uptake of biosimilars in the top 10 EU member states (MS) pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK): (1) literature review to identify incentive policies in place to enhance biosimilars adoption; (2) assessment of biosimilar market dynamics based on database analysis; (3) regression model analysis on price using the following explicative variables: incentive policies; price difference between the biosimilar and the originator product; distribution channel; generic uptake and generic price cut; pharmaceutical expenditure per capita; and market competition. Results : At the study cut-off date, 20 biosimilars were available on the market. Incentive policies applied to biosimilars were found to be heterogeneous across countries, and uptakes of biosimilars were also very heterogeneous between different therapeutic classes and countries. Results from the model demonstrated that incentive policies and the date of first biosimilar market entry were correlated to biosimilar uptake. Pharmaceutical expenditure per capita and the highest generic uptake were inversely correlated with biosimilar uptake. Average generic price discount over originator and the number of biosimilars showed a trend toward statistical significance for correlation with biosimilar uptake, but did not reach the significance threshold. Biosimilar price discount over original biologic price, the number of analogues, and the distribution channel were not correlated with the biosimilar uptake. Conclusions : Understanding drivers of biosimilar uptake becomes a critical issue to inform policy decision-makers. This study showed that incentive policies to enhance uptake remain an important driver of biosimilar penetration, while biosimilar price discounts have no impact. Future research is warranted when the biosimilar market gains maturity.

Key drivers for market penetration of biosimilars in Europe

PubMed Central

Rémuzat, Cécile; Dorey, Julie; Cristeau, Olivier; Ionescu, Dan; Radière, Guerric; Toumi, Mondher

2017-01-01

ABSTRACT Background & Objectives: Potential drivers and barriers of biosimilar uptake were mainly analysed through qualitative approaches. The study objective was to conduct a quantitative analysis and identify drivers of biosimilar uptake of all available biosimilars in the European Union (EU). Methods: A three-step process was established to identify key drivers for the uptake of biosimilars in the top 10 EU member states (MS) pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK): (1) literature review to identify incentive policies in place to enhance biosimilars adoption; (2) assessment of biosimilar market dynamics based on database analysis; (3) regression model analysis on price using the following explicative variables: incentive policies; price difference between the biosimilar and the originator product; distribution channel; generic uptake and generic price cut; pharmaceutical expenditure per capita; and market competition. Results: At the study cut-off date, 20 biosimilars were available on the market. Incentive policies applied to biosimilars were found to be heterogeneous across countries, and uptakes of biosimilars were also very heterogeneous between different therapeutic classes and countries. Results from the model demonstrated that incentive policies and the date of first biosimilar market entry were correlated to biosimilar uptake. Pharmaceutical expenditure per capita and the highest generic uptake were inversely correlated with biosimilar uptake. Average generic price discount over originator and the number of biosimilars showed a trend toward statistical significance for correlation with biosimilar uptake, but did not reach the significance threshold. Biosimilar price discount over original biologic price, the number of analogues, and the distribution channel were not correlated with the biosimilar uptake. Conclusions: Understanding drivers of biosimilar uptake becomes a critical issue to inform policy decision-makers. This study showed that incentive policies to enhance uptake remain an important driver of biosimilar penetration, while biosimilar price discounts have no impact. Future research is warranted when the biosimilar market gains maturity. PMID:28265349

Generic ICT Skills Profiles: Future Skills for Tomorrow's World.

ERIC Educational Resources Information Center

International Co-operation Europe Ltd. (ICEL), Brussels, Belgium.

This document describes generic skills profiles relevant to key jobs in information and communications technology (ICT). The profiles cover the main job areas for which the ICT industry is experiencing skills shortages. These types of information are provided for 18 generic job profiles: job description (vision, role, lifestyle); examples of job…

Unnatural selection: talent identification and development in sport.

PubMed

Abbott, Angela; Button, Chris; Pepping, Gert-Jan; Collins, Dave

2005-01-01

The early identification of talented individuals has become increasingly important across many performance domains. Current talent identification (TI) schemes in sport typically select on the basis of discrete, unidimensional measures at unstable periods in the athlete's development. In this article, the concept of talent is revised as a complex, dynamical system in which future behaviors emerge from an interaction of key performance determinants such as psychological behaviors, motor abilities, and physical characteristics. Key nonlinear dynamics concepts are related to TI approaches such as sensitivity to initial conditions, transitions, and exponential behavioral distributions. It is concluded that many TI models place an overemphasis on early identification rather than the development of potentially talented performers. A generic model of talent identification and development is proposed that addresses these issues and provides direction for future research.

Evaluation of the "e-rater"® Scoring Engine for the "GRE"® Issue and Argument Prompts. Research Report. ETS RR-12-02

ERIC Educational Resources Information Center

Ramineni, Chaitanya; Trapani, Catherine S.; Williamson, David M.; Davey, Tim; Bridgeman, Brent

2012-01-01

Automated scoring models for the "e-rater"® scoring engine were built and evaluated for the "GRE"® argument and issue-writing tasks. Prompt-specific, generic, and generic with prompt-specific intercept scoring models were built and evaluation statistics such as weighted kappas, Pearson correlations, standardized difference in…

77 FR 46127 - Interim Staff Guidance on Changes to the Generic Aging Lessons Learned (GALL) Report Revision 2...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-02

... Aging Lessons Learned (GALL) Report Revision 2 AMP XI.M41, ``Buried and Underground Piping and Tanks... AMPs in NUREG-1801, Revision 2, ``Generic Aging Lessons Learned (GALL) Report,'' and the NRC staff's... issues LR-ISG to communicate insights and lessons learned and to address emergent issues not covered in...

76 FR 54507 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-01

... design estimates. Analyses performed under the Generic Issue program (GIP) indicated the need to evaluate... Examination of External Events (IPEEE) for Severe Accident Vulnerabilities,'' (ADAMS Accession No. ML031150485) to request that each licensee identify and report to the NRC all plant- specific vulnerabilities to...

Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.

PubMed

Rostron, Allen

2011-02-01

Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

The importance of being first: evidence from Canadian generic pharmaceuticals.

PubMed

Hollis, Aidan

2002-12-01

This paper uses pooled cross-section data on Canadian ethical drug sales to examine the effect of entry timing on sales of generic drugs. The data is for all drugs for which the first generic competitor entered during the years 1994-1997. It is found that the first generic entrant has a lasting competitive advantage: being first into the market appears to lead to an increase of around 30% in market share (among generics) over a period of at least 4 years. This finding has considerable implications for the current policy of allowing brandname drug companies to issue pseudo-generic equivalents as a preemptive strike against true generic competitors. Copyright 2002 John Wiley & Sons, Ltd.

The influence of generic substitution on the content of patient-pharmacist communication in Swedish community pharmacies.

PubMed

Olsson, Erika; Wallach-Kildemoes, Helle; Ahmed, Ban; Ingman, Pontus; Kaae, Susanne; Kälvemark Sporrong, Sofia

2017-08-01

The objective was to study the relationship between the length and content of patient-pharmacist communication in community pharmacies, and generic substitution. The study was conducted in six community pharmacies in Sweden. Non-participant observations with audio recordings and short structured interviews were conducted. Out of 32 pharmacists 29 agreed to participate (90.6%), as did 282 out of 407 patients (69.3%). Logistic regression analysis was applied to calculate odds ratio for occurrence of generic substitution. Linear regression (β-coefficients) was applied to test for differences in time spent on different categories. In encounters where generic substitution occurred more time (19.2 s) was spent on non-medical (for instance administrative or economical) issues (P = 0.01, 95% confidence interval 4.8-33.6). However, the total time of the encounter was not significantly longer. The amount of time spent on non-medical issues increased with age of patient (age 60+: β, 33 s, P < 0.001). The results indicate that more time was spent on medical issues with patients who have a higher education (high school: β, 10.8 s, P = 0.07, university: β, 10.2 s, P = 0.11) relative to those with only elementary school education. Occurrence of generic substitution was correlated with more time spent on communicating on non-medical, but not on medical, issues. No extra time was spent on medical information for the groups normally overrepresented among those with low health literacy. This study suggests that pharmacists need to further embrace their role in promoting rational use of medicines, not least when generic substitution occurs. © 2016 Royal Pharmaceutical Society.

Is it ethical to prescribe generic immunosuppressive drugs to renal transplant patients?

PubMed

Allard, Julie; Fortin, Marie-Chantal

2014-01-01

This review was conducted to determine the ethical acceptability of prescribing generic immunosuppressive drugs to renal transplant patients. The literature search was conducted using Pubmed and Google Scholar. The use of generic immunosuppressive drugs (ISDs) in transplantation is a controversial topic. There is a consensus among transplant societies that clinical data is lacking and that caution should be exercised. The reluctance to use generic ISDs in organ transplantation is partly related to the fact that most are "critical dose drugs", and that either low dosing or overdosing could have serious adverse consequences for both patients and society (i.e., the loss of scarce organs). In this paper, we examine the various ethical issues involved such as distributive justice, physician duties, risks versus benefits, conflict of interest, informed consent, and logistical and economic issues. Our analysis was limited by the paucity of clinical data on generic ISDs and the absence of health economics studies to quantify the benefits of prescribing generic ISDs. Our study led us to conclude that it would be ethical to prescribe generic ISDs provided certain conditions were met. These include regulatory safeguards to minimize the risks of substitution; education of patients; and further clinical and health economics studies to better inform clinicians, patients and society of the risks and costs related to drug substitution.

Larvae of five horticulturally important species of Chrysopodes (Neuroptera, Chrysopidae): shared generic features, descriptions and keys

PubMed Central

Silva, Patrícia S.; Tauber, Catherine A.; Albuquerque, Gilberto S.; Tauber, Maurice J.

2013-01-01

Abstract An expanded list of generic level larval characteristics is presented for Chrysopodes; it includes a reinterpretation of the mesothoracic and metathoracic structure and setation. Keys, descriptions and images of Semaphoront A (first instar) and Semaphoront B (second and third instars) are offered for identifying five species of Chrysopodes (Chrysopodes) that are commonly reported from horticultural habitats in the Neotropical region. PMID:23653514

Cognitive and affective determinants of generic drug acceptance and use: cross-sectional and experimental findings

PubMed Central

Dohle, Simone; Siegrist, Michael

2013-01-01

An increase in generic substitution could be a viable approach to reduce global healthcare expenditures. In many countries, however, generic drug use is rather low. This study examines cognitive predictors (knowledge and beliefs) and affective predictors (general affect and sacred values) to explain generic drug acceptance and use. Data for the study come from a random postal survey conducted in Switzerland (N = 668). A detailed knowledge scale about generic drugs was developed. In addition, an experimental choice task was constructed in which respondents chose between branded and generic drugs. Generic drug acceptance as well as drug choices were influenced by knowledge, beliefs, and affect. It was also found that generic substitution is chosen less frequently for a more severe illness. Key insights could be used for developing information material or interventions aimed at increasing the substitution of generic drugs in order to make health care more affordable. PMID:25632372

Experiences in methods to involve key players in planning protective actions in the case of a nuclear accident.

PubMed

Sinkko, K; Hämäläinen, R P; Hänninen, R

2004-01-01

A widely used method in the planning of protective actions is to establish a stakeholder network to generate a comprehensive set of generic protective actions. The aim is to increase competence and build links for communication and coordination. The approach of this work was to systematically evaluate protective action strategies in the case of a nuclear accident. This was done in a way that the concerns and issues of all key players could be transparently and equally included in the decision taken. An approach called Facilitated Decision Analysis Workshop has been developed and tested. The work builds on case studies in which it was assumed that a hypothetical accident had led to a release of considerable amounts of radionuclides and, therefore, various types of countermeasures had to be considered. Six workshops were organised in the Nordic countries where the key players were represented, i.e. authorities, expert organisations, industry and agricultural producers. Copyright 2004 Oxford University Press

Knowledge, attitudes and practices of community pharmacists on generic medicines in Palestine: a cross-sectional study.

PubMed

Shraim, Naser Y; Al Taha, Tasneem A; Qawasmeh, Rawan F; Jarrar, Hiba N; Shtaya, Maram A N; Shayeb, Lama A; Sweileh, Waleed M

2017-12-28

Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine. This study was a cross-sectional observational study employing a self-administered questionnaire. The questionnaire was of four main sections: demographic and practice details of the participants, knowledge, attitudes and the influencing factors related to selection and dispensing of generic medicines. A convenience sampling technique was implemented in this study in which the data collection form was distributed in West Bank- Palestine among a set of practicing pharmacists. Mann-Whitney-U or Kruskal-Wallis tests were used to comparison of different issues as appropriate. P-values of <0.05 were considered significant. A total of 302 community pharmacists were interviewed, slightly more than half were males (52.3%). The mean knowledge score of participants regarding generic medicines was (5.91 ± 1.27) where the highest score was 8 of 10. Knowledge score was not significantly influenced by any of the socio-demographic characteristics. Our data showed that most of included pharmacists in the study (95.4%) agreed that health authorities should implement bioequivalence policies prior to marketing approval of generics, while 87.4% of participants agreed that they should be given the right to substitute generics and the majority (62.3%) support generic substitution for brand name drugs in all cases when a generic is available The main two factors affect pharmacists' selection and dispensing of generic medicines are personal faith in the product (86.1%) and cost effectiveness of generic medicines (84.1%). Generic medicines substitution among pharmacists is widespread and prevalent. Our data found that participant pharmacists in Palestine had basic knowledge with regards to generic medicine. However, their knowledge score pertaining the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters in particular was insufficient.

Generic medicines: solutions for a sustainable drug market?

PubMed

Dylst, Pieter; Vulto, Arnold; Godman, Brian; Simoens, Steven

2013-10-01

Generic medicines offer equally high-quality treatment as originator medicines do at much lower prices. As such, they represent a considerable opportunity for authorities to obtain substantial savings. At the moment, the pharmaceutical landscape is changing and many pharmaceutical companies have altered their development and commercial strategies, combining both originator and generic divisions. In spite of this, the generic medicines industry is currently facing a number of challenges: delayed market access; the limited price differential with originator medicines; the continuous downwards pressure on prices; and the negative perception regarding generic medicines held by some key stakeholder groups. This could jeopardize the long-term sustainability of the generic manufacturing industry. Therefore, governments must focus on demand-side policies, alongside policies to accelerate market access, as the generic medicines industry will only be able to deliver competitive and sustainable prices if they are ensured a high volume. In the future, the generic medicines industry will increasingly look to biosimilars and generic versions of orphan drugs to expand their business.

Contemporary generic market in Japan - key conditions to successful evolution.

PubMed

Jakovljevic, Mihajlo B; Nakazono, Sanae; Ogura, Seiritsu

2014-04-01

The Japanese pharmaceutical market, the world's second largest, is traditionally renowned for the domination of patented drugs and the weakest generics share among major established economies. An in-depth observation of published evidence in Japanese/English language provided closer insight into current trends in Japanese domestic legislation and pharmaceutical market development. Recent governmental interventions have resulted in significant expansion of the generic medicines market size. Substantial savings due to generic substitution of patent-protected drugs have already been achieved and are likely to increase in future. Nationwide population aging threatening sustainable healthcare funding is contributing to the relevance of generic policy success. Serious long-term challenges to the modest Japanese generic manufacturing capacities will be posed by foreign pharmaceutical industries particularly the ones based in emerging BRIC economies.

The critical success factor approach to strategic alignment: seeking a trail from a health organization's goals to its management information infrastructure.

PubMed

Tan, J K

1999-11-01

The critical success factor (CSF) approach is a technique that will aid health administrators, planners and managers to identify, specify and sort among the most relevant and critical factors determining an organization's survival and success. Following a top-down management perspective, this paper discusses the CSF methodology as a strategic information management process comprising several important phases: (i) understanding the external factors such as the organization's industry, market and environment; (ii) achieving strong support and championship from top management; (iii) encouraging the proactive involvement of management and staff in generic CSF identification; (iv) educating and directing the participation of staff members in CSF verification and further refinement of generic CSFs into specific CSFs; and (v) aggregating, prioritizing and translating activity-related CSFs into organizational information requirements for the design of the organization's management information infrastructure. The implementation of this CSF approach is illustrated in the context of a British Columbia community hospital, with insights provided into key issues for future health researchers and practitioners.

Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending.

PubMed

Wouters, Olivier J; Kanavos, Panos G; McKEE, Martin

2017-09-01

Policy Points: Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. Rising drug prices are putting pressure on health care budgets. Policymakers are assessing how they can save money through generic drugs. We compared generic drug prices and market shares in 13 European countries, using data from 2013, to assess the amount of variation that exists between countries. To place these results in context, we reviewed evidence from recent studies on the prices and use of generics in Europe and the United States. We also surveyed peer-reviewed studies, gray literature, and books published since 2000 to (1) outline existing generic drug policies in European countries and the United States; (2) identify ways to increase generic drug use and to promote price competition among generic drug companies; and (3) explore barriers to implementing reform of generic drug policies, using a historical example from the United States as a case study. The prices and market shares of generics vary widely across Europe. For example, prices charged by manufacturers in Switzerland are, on average, more than 2.5 times those in Germany and more than 6 times those in the United Kingdom, based on the results of a commonly used price index. The proportion of prescriptions filled with generics ranges from 17% in Switzerland to 83% in the United Kingdom. By comparison, the United States has historically had low generic drug prices and high rates of generic drug use (84% in 2013), but has in recent years experienced sharp price increases for some off-patent products. There are policy solutions to address issues in Europe and the United States, such as streamlining the generic drug approval process and requiring generic prescribing and substitution where such policies are not yet in place. The history of substitution laws in the United States provides insights into the economic, political, and cultural issues influencing the adoption of generic drug policies. Governments should apply coherent supply- and demand-side policies in generic drug markets. An immediate priority is to convince more physicians, pharmacists, and patients that generic drugs are bioequivalent to branded products. Special-interest groups continue to obstruct reform in Europe and the United States. © 2017 The Authors The Milbank Quarterly published by Wiley Periodicals, Inc. on behalf of The Millbank Memorial Fund.

Contextualising Higher Education Assessment Task Words with an "'Anti'-Glossary" Approach

ERIC Educational Resources Information Center

Richards, Kendall; Pilcher, Nick

2014-01-01

Key "generic" assessment task words such as "discuss" and "critically evaluate" are integral to higher education assessment. Although sources such as study skills guides give generic decontextualised glossaries of these words, much research rightly argues for greater dialogue between students (particularly…

A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

1995-11-01

The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors.more » To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report.« less

Pharmacists' views and reported practices in relation to a new generic drug substitution policy in Lebanon: a mixed methods study.

PubMed

El-Jardali, Fadi; Fadlallah, Racha; Morsi, Rami Z; Hemadi, Nour; Al-Gibbawi, Mounir; Haj, Magda; Khalil, Suzan; Saklawi, Youssef; Jamal, Diana; Akl, Elie A

2017-02-17

Governments in both developed and developing countries have adopted generic drug substitution policies to decrease pharmaceutical expenditures and improve access to medicine. In August 2015, the Ministry of Public Health (MOPH) in Lebanon introduced generic drug substitution and a unified medical prescription form as policy instruments to promote generic drug use. The objective of this exploratory study was to examine the attitudes of community pharmacists and the reported practices in relation to the implementation of the new generic drug substitution policy. We used a cross-sectional mixed methods approach composed of self-administered questionnaires and semi-structured interviews. The study population consisted of community pharmacists in Lebanon. We randomly approached one pharmacy personnel from each selected community pharmacy. We conducted descriptive analyses to assess responses to questionnaire and regression analyses to understand associations between responses and respondent demographics. We analyzed qualitative data thematically. Out of 204 invited community pharmacies, 153 pharmacies participated (75% response rate). The majority of respondents (64%) were in favor of generic drug substitution; however, less than half (40%) indicated they have substituted brand drugs for generic equivalents. Moreover, 57% indicated that the existing pricing system discourages them from performing generic drug substitution. Most respondents indicated that physicians are overusing the "non-substitutable" option (84%) and that there are technical problems with processing the new prescription form (78%). Less than half (47%) reported that the MOPH is performing regular audits on the forms collected by the pharmacy. While 45% of the respondents indicated that consumers have accepted most of the generic substitutions, 21% perceived the increase in generic drug dispensing to be significant. Findings suggested a potentially significant association between being informed about generic drugs and respondents' support of the policy. Suggested strategies to address implementation challenges included strengthening stewardship function of MOPH, securing full commitment of health care providers, conducting educational and awareness campaigns about generic drugs and generic drug substitution, and aligning incentive systems of the key stakeholders. The majority of community pharmacists were supportive of generic drug substitution in general but not of the current implementation of the policy in Lebanon. Findings revealed implementation challenges at the provider, patient, and system level which are hindering attainment of the policy objectives. The key lessons derived from this study can be used for continuous improvement of the policy and its implementation.

Children's interpretations of general quantifiers, specific quantifiers, and generics

PubMed Central

Gelman, Susan A.; Leslie, Sarah-Jane; Was, Alexandra M.; Koch, Christina M.

2014-01-01

Recently, several scholars have hypothesized that generics are a default mode of generalization, and thus that young children may at first treat quantifiers as if they were generic in meaning. To address this issue, the present experiment provides the first in-depth, controlled examination of the interpretation of generics compared to both general quantifiers ("all Xs", "some Xs") and specific quantifiers ("all of these Xs", "some of these Xs"). We provided children (3 and 5 years) and adults with explicit frequency information regarding properties of novel categories, to chart when "some", "all", and generics are deemed appropriate. The data reveal three main findings. First, even 3-year-olds distinguish generics from quantifiers. Second, when children make errors, they tend to be in the direction of treating quantifiers like generics. Third, children were more accurate when interpreting specific versus general quantifiers. We interpret these data as providing evidence for the position that generics are a default mode of generalization, especially when reasoning about kinds. PMID:25893205

Cosmic backreaction and Gauss's law

NASA Astrophysics Data System (ADS)

Fleury, Pierre

2017-06-01

Cosmic backreaction refers to the general question of whether a homogeneous and isotropic cosmological model is able to predict the correct expansion dynamics of our inhomogeneous Universe. One aspect of this issue concerns the validity of the continuous approximation: does a system of point masses expand the same way as a fluid does? This article shows that it is not exactly the case in Newtonian gravity, although the associated corrections vanish in an infinite Universe. It turns out that Gauss's law is a key ingredient for such corrections to vanish. Backreaction, therefore, generically arises in alternative theories of gravitation, which threatens the trustworthiness of their cosmological tests. This phenomenon is illustrated with a toy model of massive gravity.

Generic immunosuppression in transplantation: current evidence and controversial issues.

PubMed

El Hajj, Sandra; Kim, Miae; Phillips, Karen; Gabardi, Steven

2015-05-01

The overall success of organ transplantation in the 21st century has been predicated, in part, on the use of newer, more potent, and selective immunosuppressive agents. However, the high cost of lifelong immunosuppression represents a financial burden for many patients. In the past 15 years, regulatory agencies in Europe and America have approved several generic immunosuppressants. One concern is whether the conversion between innovator and generic immunosuppressants will prove to be problematic. This manuscript aims to compare and contrast the bioequivalence requirements among regulatory authorities in the USA, Europe, and Canada, evaluate published studies of generic immunosuppressants in transplant recipients, summarize consensus statements made by transplant organizations and discuss how to engage patients in discussion regarding the choice between innovator and generic immunosuppressants.

The Impact of Generic Competencies on Workplace Performance. Review of Research.

ERIC Educational Resources Information Center

Moy, Janelle

The impact of generic competencies on workplace performance was examined through a review of literature and evaluation research which focused on conceptualization and piloting of the following key competencies in Australia in 1993-1998: collecting, analyzing, and organizing information; communicating ideas and information; planning and organizing…

Comparative Economic Organization: The Analysis of Discrete Structural Alternatives.

ERIC Educational Resources Information Center

Williamson, Oliver E.

1991-01-01

Combines institutional economics with aspects of contract law and organization theory to identify and explicate the key differences distinguishing three generic forms of economic organization: market, hybrid, and hierarchy. These generic forms are distinguished by different coordinating and control mechanisms and by different abilities to adapt to…

76 FR 3540 - Proposed Generic Communications Reporting for Decommissioning Funding Status Reports

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-20

...-2010-0366] Proposed Generic Communications Reporting for Decommissioning Funding Status Reports AGENCY... and present to the NRC in the Decommissioning Funding Status reports to ensure that the NRC staff... Regulatory Issue Summary 2010-XXX, ``10 CFR 50-75, Reporting for Decommissioning Funding Status Reports'' is...

Generic medicine pricing in Europe: current issues and future perspective.

PubMed

Simoens, Steven

2008-01-01

This editorial discusses a number of trends affecting the pricing of generic medicines in Europe. With respect to pricing, recent evidence has emerged that European generic medicine manufacturers face competition from Indian manufacturers; that the price level of generic medicines varies substantially between European countries; and that generic medicine manufacturers engage in competition by discount rather than price competition in France, The Netherlands and the UK. These trends suggest that there may be scope for further reducing the prices of generic medicines in several countries. In relation to reference pricing, most European countries have incorporated market incentives within reference pricing systems with a view to promoting price competition. The European experience indicates that the generic medicines industry delivers competitive prices under a reference pricing system if demand-side policies are in place that stimulate physicians, pharmacists and patients to use generic medicines. Finally, caution needs to be exercised when focusing on the drivers of generic medicine pricing as these drivers not only vary between countries, but may also vary within a country. Manufacturers of originator and generic medicines do not take a single pricing approach following patent expiry, but vary their pricing strategy from molecule to molecule.

Emergency management in health: key issues and challenges in the UK.

PubMed

Lee, Andrew C K; Phillips, Wendy; Challen, Kirsty; Goodacre, Steve

2012-10-19

Emergency planning in the UK has grown considerably in recent years, galvanised by the threat of terrorism. However, deficiencies in NHS emergency planning were identified and the evidence-base that underpins it is questionable. Inconsistencies in terminologies and concepts also exist. Different models of emergency management exist internationally but the optimal system is unknown. This study examines the evidence-base and evidence requirements for emergency planning in the UK health context. The study involved semi-structured interviews with key stakeholders and opinion leaders. Purposive sampling was used to obtain a breadth of views from various agencies involved in emergency planning and response. Interviews were then analysed using a grounded approach using standard framework analysis techniques. We conducted 17 key informant interviews. Interviewees identified greater gaps in operational than technical aspects of emergency planning. Social and behavioural knowledge gaps were highlighted with regards to how individuals and organisations deal with risk and behave in emergencies. Evidence-based approaches to public engagement and for developing community resilience to disasters are lacking. Other gaps included how knowledge was developed and used. Conflicting views with regards to the optimal configuration and operation of the emergency management system were voiced. Four thematic categories for future research emerged:(i) Knowledge-base for emergency management: Further exploration is needed of how knowledge is acquired, valued, disseminated, adopted and retained.(ii) Social and behavioural issues: Greater understanding of how individuals approach risk and behave in emergencies is required.(iii) Organisational issues in emergencies: Several conflicting organisational issues were identified; value of planning versus plans, flexible versus standardized procedures, top-down versus bottom-up engagement, generic versus specific planning, and reactive versus proactive approaches to emergencies.(iv) Emergency management system: More study is required of system-wide issues relating to system configuration and operation, public engagement, and how emergency planning is assessed.

Sharing, samples, and generics: an antitrust framework.

PubMed

Carrier, Michael A

Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition. Regulations such as the federal Hatch-Waxman Act and state substitution laws foster widespread generic competition. But these regimes can only be effectuated through generic entry. And that entry can take place only if a generic can use a brand's sample to show that its product is equivalent. More than 100 generic firms have complained that they have not been able to access needed samples. One study of 40 drugs subject to restricted access programs found that generics' inability to enter cost more than $5 billion a year. Brand firms have contended that antitrust law does not compel them to deal with their competitors and have highlighted concerns related to safety and product liability in justifying their refusals. This Article rebuts these claims. It highlights the importance of samples in the regulatory regime and the FDA's inability to address the issue. It shows how a sharing requirement in this setting is consistent with Supreme Court caselaw. And it demonstrates that the brands' behavior fails the defendant-friendly "no economic sense" test because the conduct literally makes no sense other than by harming generics. Brands' denial of samples offers a textbook case of monopolization. In the universe of pharmaceutical antitrust behavior, other conduct--such as "pay for delay" settlements between brands and generics and "product hopping" from one drug to a slightly modified version--has received the lion's share of attention. But sample denials are overdue for antitrust scrutiny. This Article fills this gap. Given the failure of Congress and the FDA to remedy the issue, antitrust can play a crucial role in ensuring generic access to samples, affirming a linchpin of the pharmaceutical regime.

Generic medicines policies in the Asia Pacific region: ways forward.

PubMed

Nguyen, Tuan A; Hassali, Mohamed A A; McLachlan, Andrew

2013-01-01

Generic medicines are a key strategy used by governments and third-party payers to contain medicines costs and improve the access to essential medicines. This strategy represents an important opportunity provided by the global intellectual property regimes to discover and develop copies of original products marketed by innovator companies once the patent protection term is over. While there is an extensive experience regarding generic medicines policies in developed countries, this evidence may not translate to developing countries. The generic medicines policies workshop at the Asia Pacific Conference on National Medicines Policies 2012 provided an important opportunity to discuss and document country-specific initiatives for improving access to and the rational of use of generic medicines in the Asia Pacific region. Based on the identified barriers and enablers to implementation of generic medicines policies in the region, a set of future action plans and recommendations has been made.

[Generic drugs and the consumption trends of antihypertensives in Morocco].

PubMed

Berrada El Azizi, Ghizlane; Ahid, Samir; Ghanname, Imane; Ghannam, Imane; Belaiche, Abdelmajid; Hassar, Mohammed; Cherrah, Yahia

2013-01-01

To evaluate the evolution of consumption of antihypertensive drugs generic among 1991-2010, to assess the impacts after the institution of Mandatory Health Insurance and the marketing of generic drugs. We used sales data from the Moroccan subsidiary of IMS Health Intercontinental Marketing Service. Consumption of generic antihypertensive drugs increased from 0.08 to 10.65 DDD/1 000 inhabitants/day between 1991 and 2010. In 2010, generic of the calcium channel blockers (CCBs) represented 4.08 DDD/1 000 inhabitants/day (82.09%), followed by angiotensin converting enzyme inhibitors (ACEI) by 2.40 DDD/1 000 inhabitants/day (48.29%). The generics market of CCBs is the most dominant and represented in 2010, 79.21% in volume and 62.58% in value. In developing countries like Morocco, the generic drug is a key element for access to treatment especially for the poor population. © 2013 Société Française de Pharmacologie et de Thérapeutique.

A survey to determine the views of renal transplant patients on generic substitution in the UK.

PubMed

Al Ameri, Mubarak N; Whittaker, Clare; Tucker, Arthur; Yaqoob, Magdi; Johnston, Atholl

2011-08-01

Rising healthcare costs promote the generic substitution among patients because it is identifiable costs. A key concern is that patients should be involved in the decision of switching. The aim of this study was to examine renal transplant patients' views on generic substitution in the UK. A total of 163 renal patients were surveyed using 36 multiple-choice questions at Barts and The London Renal Transplant Clinic, in the UK. Transplant recipients over 18 years, able to read and write English and willing to fill in the questionnaire were targeted; 84% of patients were conscious of the availability of generic medicines, 70% understood the terms "generic" and "branded" in relation to medicines and 54% were aware of generic substitution practice. However, 75% did not know if they were taking generics and 84% felt that generics are not equivalent or only equivalent sometimes and they were uncertain that generics had the same quality as branded medicines. Moreover, many patients admitted that they would not accept the generic substitution of ciclosporin when become available in the UK. A number of factors such as patients' education, knowledge, severity of the disease, efficacy of generic medicines and patients' involvement in decisions regarding their health appear to drive patients' attitudes towards generic substitution. © 2011 The Authors. Transplant International © 2011 European Society for Organ Transplantation.

e-Learning Business Research Methods

ERIC Educational Resources Information Center

Cowie, Jonathan

2004-01-01

This paper outlines the development of a generic Business Research Methods course from a simple name in a box to a full e-Learning web based module. It highlights particular issues surrounding the nature of the discipline and the integration of a large number of cross faculty subject specific research methods courses into a single generic module.…

Generic Certificates. Agricultural Economic Report Number 594.

ERIC Educational Resources Information Center

Glauber, Joseph W.

The Food Security Act of 1985 authorizes the U.S. Department of Agriculture to issue generic certificates in lieu of cash payments due to program participants and merchants of agricultural products under provisions of several programs. The certificates may be used to acquire stocks held as collateral on government loans or owned by the Commodity…

Inhalation devices: from basic science to practical use, innovative vs generic products.

PubMed

Pirozynski, Michal; Sosnowski, Tomasz R

2016-11-01

Inhalation therapy is a convenient method of treating respiratory diseases. The key factors required for inhalation are the preparation of drug carriers (aerosol particles) allowing reproducible dosing during administration. These technical challenges are accomplished with a variety of inhalation devices (inhalers) and medicinal formulations, which are optimized to be easily converted into inhalable aerosols. Areas covered: This review is focused on the most important, but often overlooked, effects, which are required for the reliable and reproducible inhalable drug administration. The effects of patient-related issues that influence inhalation therapy, such as proper selection of inhalers for specific cases is discussed. We also discuss factors that are the most essential if generic inhalation product should be considered equivalent to the drugs with the clinically confirmed efficacy. Expert opinion: Proper device selection is crucial in clinical results of inhalation therapy. The patients' ability to coordinate inhalation with actuation, generation of optimal flow through the device, use of optimal inspiratory volume, all produces crucial effects on disease control. Also the severity of the disease process effects proper use of inhalers. Interchanging of inhalers can produce potentially conflicting problem regarding efficacy and safety of inhalation therapy.

Invited Commentary on Wallace and Beange (2008): "On the Need for a Specialist Service within the Generic Hospital Setting"

ERIC Educational Resources Information Center

O'Hara, David

2008-01-01

In this article, the author comments on the paper "On the need for a specialist service within the generic hospital setting" (Wallace & Beange, 2008), which raises critical issues regarding effective models of healthcare delivery for individuals with intellectual disability (ID), particularly within a hospital setting (but not…

77 FR 14446 - Changes to the Generic Aging Lessons Learned (GALL) Report Revision 2 AMP XI.M41, “Buried and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0055] Changes to the Generic Aging Lessons Learned (GALL... Aging Lessons Learned (GALL) Report,'' and the NRC staff's aging management review procedure and... into ADAMS. II. Background The NRC issues LR-ISGs to communicate insights and lessons learned and to...

Adapting the coping in deliberation (CODE) framework: a multi-method approach in the context of familial ovarian cancer risk management.

PubMed

Witt, Jana; Elwyn, Glyn; Wood, Fiona; Rogers, Mark T; Menon, Usha; Brain, Kate

2014-11-01

To test whether the coping in deliberation (CODE) framework can be adapted to a specific preference-sensitive medical decision: risk-reducing bilateral salpingo-oophorectomy (RRSO) in women at increased risk of ovarian cancer. We performed a systematic literature search to identify issues important to women during deliberations about RRSO. Three focus groups with patients (most were pre-menopausal and untested for genetic mutations) and 11 interviews with health professionals were conducted to determine which issues mattered in the UK context. Data were used to adapt the generic CODE framework. The literature search yielded 49 relevant studies, which highlighted various issues and coping options important during deliberations, including mutation status, risks of surgery, family obligations, physician recommendation, peer support and reliable information sources. Consultations with UK stakeholders confirmed most of these factors as pertinent influences on deliberations. Questions in the generic framework were adapted to reflect the issues and coping options identified. The generic CODE framework was readily adapted to a specific preference-sensitive medical decision, showing that deliberations and coping are linked during deliberations about RRSO. Adapted versions of the CODE framework may be used to develop tailored decision support methods and materials in order to improve patient-centred care. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

The role of theory in qualitative health research.

PubMed

Kelly, Moira

2010-06-01

The role of theory in qualitative research is often underplayed but it is relevant to the quality of such research in three main ways. Theory influences research design, including decisions about what to research and the development of research questions. Theory underpins methodology and has implications for how data are analyzed and interpreted. Finally, theory about a particular health issue may be developed, contributing to what is already known about the topic that is the focus of the study. This paper will critically consider the role of theory in qualitative primary care research in relation to these three areas. Different approaches to qualitative research will be drawn upon in order to illustrate the ways in which theory might variably inform qualitative research, namely generic qualitative research, grounded theory and discourse analysis. The aim is to describe and discuss key issues and provide practical guidance so that researchers are more aware of the role theory has to play and the importance of being explicit about how theory affects design, analysis and the quality of qualitative research.

Exploring Knowledge and Perceptions of Generic Medicines Among Drug Retailers and Community Pharmacists

PubMed Central

Basak, S. C.; Sathyanarayana, D.

2012-01-01

The study was carried out to evaluate community pharmacists’ and drug retailers’ knowledge and perceptions about generic medicines. A cross-sectional descriptive study, with a questionnaire, was conducted to survey community pharmacists and drug retailers working in 39 randomly selected private pharmacies from two towns of Tamil Nadu, India. Among 66 respondents (pharmacists and drug retailers), 39 (59.1%) were drug retailers; 52 (78.8%) were self-employed; majority in the age group 31-40 (31.8%); and mostly males (83.3%). Overall, 21 respondents (31.8%) did not know what generic medicines were. About 30% of the respondents thought that generic medicines are of inferior quality compared to branded medicines. Only 63.6% of the surveyed pharmacists and drug retailers agreed that generic medicines can be considered therapeutically equivalent with the branded ones. A higher level of education had a direct relationship having correct knowledge of generic medicines (P<0.01). The majority of the respondents (80%) did not support generic substitution, even in case of prescribed medicines are not available. Many community pharmacists and drug retailers have misconceptions regarding generic medicines. Lack of knowledge may negatively affect the community pharmacists’ support towards generic medicines in India. This issue should be addressed by academicians and other relevant bodies. PMID:23798785

An evaluation of consumers' knowledge, perceptions and attitudes regarding generic medicines in Auckland.

PubMed

Babar, Zaheer-Ud-Din; Stewart, Joanna; Reddy, Shiwangni; Alzaher, Woroud; Vareed, Prateeka; Yacoub, Nineweh; Dhroptee, Bandhana; Rew, Anne

2010-08-01

The aim of this project was to evaluate the perceptions, knowledge and attitudes regarding generic medicines. A cross-sectional study, with self administered questionnaires, was conducted to survey consumers visiting pharmacies in four regions of Auckland (North Shore, Waitakere, Central Auckland and South Auckland). Through stratified random sampling, approximately 10% of pharmacies from each region were selected, which turn out to be 30 pharmacies. Every alternate customer coming to the pharmacy, who was eligible to participate in the study, was asked by the researchers to complete the questionnaire. A total of 441 questionnaires were included in the analysis. Different response rates were obtained in different regions of Auckland. Of all respondents, 51.6% had previous knowledge of generic medicines. Pharmacists were the main source of information regarding generic medicines followed by doctors and media. A higher level of education had a direct relationship with having correct knowledge of generics (P = .002). Attitude of participants toward the use of generic medicines was determined by their knowledge of generics, whether it was recommended by a pharmacist and their type of illness. Participants were more prepared to change to a generic for a minor illness (79%) than for a major illness (58.7%). Those who had better knowledge were more likely than those with poor knowledge to say they would to use a generic in major illness (P = .001) as well as minor illness (P < .0001). Previous positive experiences with generics also determined consumers' willingness to use generics. Many consumers have misconceptions regarding generic medicines. Having knowledge about generics and the advice by doctors and pharmacists are key indicators to improve the quality use of generic medicines.

Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

PubMed Central

Venkatesh, M.; Bairavi, V. G.; Sasikumar, K. C.

2011-01-01

Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.. PMID:21430959

Understanding and perceptions of final-year Doctor of Pharmacy students about generic medicines in Karachi, Pakistan: a quantitative insight

PubMed Central

Jamshed, Shazia Qasim; Ibrahim, Mohamad Izham Mohamad; Hassali, Mohamad Azmi; Sharrad, Adheed Khalid; Shafie, Asrul Akmal; Babar, Zaheer-Ud-Din

2015-01-01

General objective To evaluate the understanding and perceptions of generic medicines among final-year Doctor of Pharmacy students in Karachi, Pakistan. Methods A 23-item survey instrument that included a question on the bioequivalence limits and Likert-type scale questions regarding the understanding and perceptions of generic medicines among the students was executed. Cronbach’s alpha was found to be 0.62. Results Responses were obtained from 236 final-year Doctor of Pharmacy students (n=85 from a publicly funded institute; n=151 from a privately funded institute). When comparing a brand-name medicine to a generic medicine, pharmacy students scored poorly on bioequivalence limits. More than 80% of the students incorrectly answered that all the products that are rated as generic equivalents are therapeutically equivalent to each other (P<0.04). Half of the students agreed that a generic medicine is bioequivalent to the brand-name medicine (P<0.001). With regard to quality, effectiveness, and safety, more than 75% of the students disagreed that generic medicines are of inferior quality and are less effective than brand-name medicines (P<0.001). More than 50% of the students disagreed that generic medicines produce more side effects than brand-name medicines (P<0.001). Conclusion The current study identified a positive perception toward generic medicines but also gaps in the understanding of generic medicines. Pharmacy students lacked a thorough understanding of the concepts of bioequivalence. Pharmacy academia should address these issues, which will help build confidence in generic medicines and increase the generic medicine use in Pakistan. PMID:26028981

Automated analysis in generic groups

NASA Astrophysics Data System (ADS)

Fagerholm, Edvard

This thesis studies automated methods for analyzing hardness assumptions in generic group models, following ideas of symbolic cryptography. We define a broad class of generic and symbolic group models for different settings---symmetric or asymmetric (leveled) k-linear groups --- and prove ''computational soundness'' theorems for the symbolic models. Based on this result, we formulate a master theorem that relates the hardness of an assumption to solving problems in polynomial algebra. We systematically analyze these problems identifying different classes of assumptions and obtain decidability and undecidability results. Then, we develop automated procedures for verifying the conditions of our master theorems, and thus the validity of hardness assumptions in generic group models. The concrete outcome is an automated tool, the Generic Group Analyzer, which takes as input the statement of an assumption, and outputs either a proof of its generic hardness or shows an algebraic attack against the assumption. Structure-preserving signatures are signature schemes defined over bilinear groups in which messages, public keys and signatures are group elements, and the verification algorithm consists of evaluating ''pairing-product equations''. Recent work on structure-preserving signatures studies optimality of these schemes in terms of the number of group elements needed in the verification key and the signature, and the number of pairing-product equations in the verification algorithm. While the size of keys and signatures is crucial for many applications, another aspect of performance is the time it takes to verify a signature. The most expensive operation during verification is the computation of pairings. However, the concrete number of pairings is not captured by the number of pairing-product equations considered in earlier work. We consider the question of what is the minimal number of pairing computations needed to verify structure-preserving signatures. We build an automated tool to search for structure-preserving signatures matching a template. Through exhaustive search we conjecture lower bounds for the number of pairings required in the Type~II setting and prove our conjecture to be true. Finally, our tool exhibits examples of structure-preserving signatures matching the lower bounds, which proves tightness of our bounds, as well as improves on previously known structure-preserving signature schemes.

Simulation system architecture design for generic communications link

NASA Technical Reports Server (NTRS)

Tsang, Chit-Sang; Ratliff, Jim

1986-01-01

This paper addresses a computer simulation system architecture design for generic digital communications systems. It addresses the issues of an overall system architecture in order to achieve a user-friendly, efficient, and yet easily implementable simulation system. The system block diagram and its individual functional components are described in detail. Software implementation is discussed with the VAX/VMS operating system used as a target environment.

Impact on Bacterial Resistance of Therapeutically Nonequivalent Generics: The Case of Piperacillin-Tazobactam

PubMed Central

Rodriguez, Carlos A.; Agudelo, Maria; Aguilar, Yudy A.; Zuluaga, Andres F.

2016-01-01

Previous studies have demonstrated that pharmaceutical equivalence and pharmacokinetic equivalence of generic antibiotics are necessary but not sufficient conditions to guarantee therapeutic equivalence (better called pharmacodynamic equivalence). In addition, there is scientific evidence suggesting a direct link between pharmacodynamic nonequivalence of generic vancomycin and promotion of resistance in Staphylococcus aureus. To find out if even subtle deviations from the expected pharmacodynamic behavior with respect to the innovator could favor resistance, we studied a generic product of piperacillin-tazobactam characterized by pharmaceutical and pharmacokinetic equivalence but a faulty fit of Hill’s Emax sigmoid model that could be interpreted as pharmacodynamic nonequivalence. We determined the impact in vivo of this generic product on the resistance of a mixed Escherichia coli population composed of ∼99% susceptible cells (ATCC 35218 strain) and a ∼1% isogenic resistant subpopulation that overproduces TEM-1 β-lactamase. After only 24 hours of treatment in the neutropenic murine thigh infection model, the generic amplified the resistant subpopulation up to 20-times compared with the innovator, following an inverted-U dose-response relationship. These findings highlight the critical role of therapeutic nonequivalence of generic antibiotics as a key factor contributing to the global problem of bacterial resistance. PMID:27191163

Preparing students for the ethical challenges on international health electives: A systematic review of the literature on educational interventions.

PubMed

Rahim, Anika; Knights Née Jones, Felicity; Fyfe, Molly; Alagarajah, Janagan; Baraitser, Paula

2016-09-01

International health electives pose specific ethical challenges for students travelling from to low and middle income countries. We undertook a systematic review of the literature on interventions to prepare students to identify ethical issues addressed, educational approaches and to collate evidence on the effectiveness of different strategies. We searched nine electronic databases of peer-reviewed literature and identified grey literature through key word searches; supplemented through citation mapping and expert consultation. Articles that described ethical training conducted by universities or professional bodies were included for review. We reviewed forty-four full text articles. Ten sources of published literature and seven sources of grey literature met our inclusion criteria. We identified thirteen ethical situations that students should be prepared to manage and eight generic skills to support this process. Most interventions were delivered before the elective, used case studies or guidelines. Some suggested ethical principles or a framework for analysis of ethical issues. Only two papers evaluated the intervention described. Our paper collates a small but growing body of work on education to prepare students to manage ethical issues. Ethical training should have elements that are delivered before, during and after the elective. Interventions should include case studies covering thirteen ethical issues identified here, linked to ethical principles and a process for responding to ethical issues. We suggest that evaluations of interventions are an important area for future research.

Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard.

PubMed

Ting, Tricia Y; Jiang, Wenlei; Lionberger, Robert; Wong, Jessica; Jones, Jace W; Kane, Maureen A; Krumholz, Allan; Temple, Robert; Polli, James E

2015-09-01

To test the current U.S. Food and Drug Administration (FDA) bioequivalence standard in a comparison of generic and brand-name drug pharmacokinetic (PK) performance in "generic-brittle" patients with epilepsy under clinical use conditions. This randomized, double-blind, multiple-dose, steady-state, fully replicated bioequivalence study compared generic lamotrigine to brand-name Lamictal in "generic-brittle" patients with epilepsy (n = 34) who were already taking lamotrigine. Patients were repeatedly switched between masked Lamictal and generic lamotrigine. Intensive PK blood sampling at the end of each 2-week treatment period yielded two 12-h PK profiles for brand-name and generic forms for each patient. Steady-state area under the curve (AUC), peak plasma concentration (Cmax ), and minimum plasma concentration (Cmin ) data were subjected to conventional average bioequivalence (ABE) analysis, reference-scaled ABE analysis, and within-subject variability (WSV) comparisons. In addition, generic-versus-brand comparisons in individual patients were performed. Secondary clinical outcomes included seizure frequency and adverse events. Generic demonstrated bioequivalence to brand. The 90% confidence intervals of the mean for steady-state AUC, Cmax , and Cmin for generic-versus-brand were 97.2-101.6%, 98.8-104.5%, and 93.4-101.0%, respectively. The WSV of generic and brand were also similar. Individual patient PK ratios for generic-versus-brand were similar but not identical, in part because brand-versus-brand profiles were not identical, even though subjects were rechallenged with the same product. Few subjects had seizure exacerbations or tolerability issues with product switching. One subject, however, reported 267 focal motor seizures, primarily on generic, although his brand and generic PK profiles were practically identical. Some neurologists question whether bioequivalence in healthy volunteers ensures therapeutic equivalence of brand and generic antiepileptic drugs in patients with epilepsy, who may be at increased risk for problems with brand-to-generic switching. Bioequivalence results in "generic-brittle" patients with epilepsy under clinical conditions support the soundness of the FDA bioequivalence standards. Adverse events on generic were not related to the small, allowable PK differences between generic and brand. Wiley Periodicals, Inc. © 2015 International League Against Epilepsy.

Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation

PubMed Central

Johnston, Atholl

2013-01-01

The calcineurin inhibitors (CNIs), ciclosporin and tacrolimus, are the mainstay of immunosuppression in solid organ transplantation. Generic formulations of these drugs are now available. With increasing pressure on healthcare budgets and the consequent need to match health expectations to available resources, substitution with a generic product appears an attractive option to reduce costs. Approval of generic products differs from innovator drugs, and narrow therapeutic index drugs (NTIs; including CNIs) bring their own particular considerations. With NTIs, small variations in drug exposure could result in reduced immunosuppression or drug toxicity with potentially adverse effects on patient outcomes. NTIs are subject to stricter regulatory approval versus many other generic drugs. However, different generic formulations may still not necessarily be therapeutically equivalent in individuals, raising the possibility of significant differences in exposure between products. Although regional recommendations vary, many guidelines emphasise the need for NTI drug substitution to be initiated by the transplant physician, thus ensuring careful therapeutic monitoring and reduced negative patient impact. The need for therapeutic monitoring during generic substitution has important implications for the overall costs of generic treatment as these costs have to be factored in to the potential savings made from using generic formulations. The reduced acquisition costs of generic products may not necessarily translate into lower overall healthcare costs. This article examines the issue of equivalence and interchangeability of NTI drugs used in organ transplantation, the implications of the approval process for generic drugs on treatment efficacy and safety, and the effective management of substitutions between products. PMID:24089632

A vision of the pharmaceutical industry.

PubMed

Muñio, S

1998-01-01

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

Impact of the trade-related aspects of intellectual property rights (TRIPS) agreement on India as a supplier of generic antiretrovirals.

PubMed

Babovic, Sonja; Wasan, Kishor M

2011-03-01

This is a commentary on how the trade-related aspects of intellectual property rights (TRIPS) agreement has impacted India as a supplier of generic antiretrovirals (ARVs). We provide a systematic review of the issues related to the TRIPS agreement that affects India. This includes discussion around (a) the legal landscape underpinning India as a supplier of generic ARVs; (b) supply of second-line ARVs; and (c) the future of generic drug production in India. The proclamation into force of TRIPS-compliant intellectual property law in India is likely to affect its position as a supplier of affordable ARVs, especially drugs brought to market after 2005. Currently, mechanisms exist for the generic production of almost all ARVs in India, including second-line drugs; however, the manufacture of these drugs by generic pharmaceutical companies may require additional market incentives. Compulsory licensing may emerge as an additional mechanism by which India can provide affordable versions of patented drugs to Least Developed Countries (LDCs). Copyright © 2010 Wiley-Liss, Inc.

76 FR 40282 - Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX; NRC Regulation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-08

... Commission (NRC) is proposing to issue a RIS that clarifies those discrete sources of radium-226 under... Officers. Intent The NRC is issuing this RIS to clarify which discrete sources of radium-226 under military... definition of byproduct material to include discrete sources of radium-226, discrete sources of naturally...

The Introduction of Key Skills in Schools: Core or Casualty?

ERIC Educational Resources Information Center

Glover, Derek; Gleeson, Denis; Johnson, Mike; Spencer, Pat; Watson, Ray

2000-01-01

Study of the introduction of generic Key Skills in two local education authorities in Britain found limited implementation. Results suggested the need for strategic district- and school-level management, clear aims and objectives, ownership by school staff, and cross-curricular application. (SK)

A life scientist's gateway to distributed data management and computing: the PathPort/ToolBus framework.

PubMed

Eckart, J Dana; Sobral, Bruno W S

2003-01-01

The emergent needs of the bioinformatics community challenge current information systems. The pace of biological data generation far outstrips Moore's Law. Therefore, a gap continues to widen between the capabilities to produce biological (molecular and cell) data sets and the capability to manage and analyze these data sets. As a result, Federal investments in large data set generation produces diminishing returns in terms of the community's capabilities of understanding biology and leveraging that understanding to make scientific and technological advances that improve society. We are building an open framework to address various data management issues including data and tool interoperability, nomenclature and data communication standardization, and database integration. PathPort, short for Pathogen Portal, employs a generic, web-services based framework to deal with some of the problems identified by the bioinformatics community. The motivating research goal of a scalable system to provide data management and analysis for key pathosystems, especially relating to molecular data, has resulted in a generic framework using two major components. On the server-side, we employ web-services. On the client-side, a Java application called ToolBus acts as a client-side "bus" for contacting data and tools and viewing results through a single, consistent user interface.

Bayesian Inference for Time Trends in Parameter Values: Case Study for the Ageing PSA Network of the European Commission

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dana L. Kelly; Albert Malkhasyan

2010-06-01

There is a nearly ubiquitous assumption in PSA that parameter values are at least piecewise-constant in time. As a result, Bayesian inference tends to incorporate many years of plant operation, over which there have been significant changes in plant operational and maintenance practices, plant management, etc. These changes can cause significant changes in parameter values over time; however, failure to perform Bayesian inference in the proper time-dependent framework can mask these changes. Failure to question the assumption of constant parameter values, and failure to perform Bayesian inference in the proper time-dependent framework were noted as important issues in NUREG/CR-6813, performedmore » for the U. S. Nuclear Regulatory Commission’s Advisory Committee on Reactor Safeguards in 2003. That report noted that “industry lacks tools to perform time-trend analysis with Bayesian updating.” This paper describes an application of time-dependent Bayesian inference methods developed for the European Commission Ageing PSA Network. These methods utilize open-source software, implementing Markov chain Monte Carlo sampling. The paper also illustrates the development of a generic prior distribution, which incorporates multiple sources of generic data via weighting factors that address differences in key influences, such as vendor, component boundaries, conditions of the operating environment, etc.« less

76 FR 11264 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-01

... questionnaires and certain institution notices) for a series of import injury investigations that are required by... information requested in questionnaires and five-year sunset review institution notices issued under the... Commission's generic survey clearance to issue questionnaires will not apply to repetitive questionnaires...

Key Topics for High-Lift Research: A Joint Wind Tunnel/Flight Test Approach

NASA Technical Reports Server (NTRS)

Fisher, David; Thomas, Flint O.; Nelson, Robert C.

1996-01-01

Future high-lift systems must achieve improved aerodynamic performance with simpler designs that involve fewer elements and reduced maintenance costs. To expeditiously achieve this, reliable CFD design tools are required. The development of useful CFD-based design tools for high lift systems requires increased attention to unresolved flow physics issues. The complex flow field over any multi-element airfoil may be broken down into certain generic component flows which are termed high-lift building block flows. In this report a broad spectrum of key flow field physics issues relevant to the design of improved high lift systems are considered. It is demonstrated that in-flight experiments utilizing the NASA Dryden Flight Test Fixture (which is essentially an instrumented ventral fin) carried on an F-15B support aircraft can provide a novel and cost effective method by which both Reynolds and Mach number effects associated with specific high lift building block flows can be investigated. These in-flight high lift building block flow experiments are most effective when performed in conjunction with coordinated ground based wind tunnel experiments in low speed facilities. For illustrative purposes three specific examples of in-flight high lift building block flow experiments capable of yielding a high payoff are described. The report concludes with a description of a joint wind tunnel/flight test approach to high lift aerodynamics research.

Key Competencies. Second Edition.

ERIC Educational Resources Information Center

Haworth, David; Browne, Geoff

Key competencies (or generic skills) have been specified in four sources: Further Education Unit (FEU), United Kingdom (1987); Finn Report (1991) and Mayer Committee (1992), Australia; U.S. Labor Secretary's Commission on Achieving Necessary Skills (SCANS) (June 1991); and Butterworth and Lovell (1983), New South Wales. A comparison of the four…

On the use of Bayesian decision theory for issuing natural hazard warnings

NASA Astrophysics Data System (ADS)

Economou, T.; Stephenson, D. B.; Rougier, J. C.; Neal, R. A.; Mylne, K. R.

2016-10-01

Warnings for natural hazards improve societal resilience and are a good example of decision-making under uncertainty. A warning system is only useful if well defined and thus understood by stakeholders. However, most operational warning systems are heuristic: not formally or transparently defined. Bayesian decision theory provides a framework for issuing warnings under uncertainty but has not been fully exploited. Here, a decision theoretic framework is proposed for hazard warnings. The framework allows any number of warning levels and future states of nature, and a mathematical model for constructing the necessary loss functions for both generic and specific end-users is described. The approach is illustrated using one-day ahead warnings of daily severe precipitation over the UK, and compared to the current decision tool used by the UK Met Office. A probability model is proposed to predict precipitation, given ensemble forecast information, and loss functions are constructed for two generic stakeholders: an end-user and a forecaster. Results show that the Met Office tool issues fewer high-level warnings compared with our system for the generic end-user, suggesting the former may not be suitable for risk averse end-users. In addition, raw ensemble forecasts are shown to be unreliable and result in higher losses from warnings.

On the use of Bayesian decision theory for issuing natural hazard warnings.

PubMed

Economou, T; Stephenson, D B; Rougier, J C; Neal, R A; Mylne, K R

2016-10-01

Warnings for natural hazards improve societal resilience and are a good example of decision-making under uncertainty. A warning system is only useful if well defined and thus understood by stakeholders. However, most operational warning systems are heuristic: not formally or transparently defined. Bayesian decision theory provides a framework for issuing warnings under uncertainty but has not been fully exploited. Here, a decision theoretic framework is proposed for hazard warnings. The framework allows any number of warning levels and future states of nature, and a mathematical model for constructing the necessary loss functions for both generic and specific end-users is described. The approach is illustrated using one-day ahead warnings of daily severe precipitation over the UK, and compared to the current decision tool used by the UK Met Office. A probability model is proposed to predict precipitation, given ensemble forecast information, and loss functions are constructed for two generic stakeholders: an end-user and a forecaster. Results show that the Met Office tool issues fewer high-level warnings compared with our system for the generic end-user, suggesting the former may not be suitable for risk averse end-users. In addition, raw ensemble forecasts are shown to be unreliable and result in higher losses from warnings.

On the use of Bayesian decision theory for issuing natural hazard warnings

PubMed Central

Stephenson, D. B.; Rougier, J. C.; Neal, R. A.; Mylne, K. R.

2016-01-01

Warnings for natural hazards improve societal resilience and are a good example of decision-making under uncertainty. A warning system is only useful if well defined and thus understood by stakeholders. However, most operational warning systems are heuristic: not formally or transparently defined. Bayesian decision theory provides a framework for issuing warnings under uncertainty but has not been fully exploited. Here, a decision theoretic framework is proposed for hazard warnings. The framework allows any number of warning levels and future states of nature, and a mathematical model for constructing the necessary loss functions for both generic and specific end-users is described. The approach is illustrated using one-day ahead warnings of daily severe precipitation over the UK, and compared to the current decision tool used by the UK Met Office. A probability model is proposed to predict precipitation, given ensemble forecast information, and loss functions are constructed for two generic stakeholders: an end-user and a forecaster. Results show that the Met Office tool issues fewer high-level warnings compared with our system for the generic end-user, suggesting the former may not be suitable for risk averse end-users. In addition, raw ensemble forecasts are shown to be unreliable and result in higher losses from warnings. PMID:27843399

Generic Substitution of Orphan Drugs for the Treatment of Rare Diseases: Exploring the Potential Challenges.

PubMed

Di Paolo, Antonello; Arrigoni, Elena

2018-03-01

Generic drugs are important components of measures introduced by healthcare regulatory authorities to reduce treatment costs. In most patients and conditions the switch from a branded drug to its generic counterpart is performed with no major complications. However, evidence from complex diseases suggests that generic substitution requires careful evaluation in some settings and that current bioequivalence criteria may not always be adequate for establishing the interchangeability of branded and generic products. Rare diseases, also called orphan diseases, are a group of heterogeneous diseases that share important characteristics: in addition to their scarcity, most are severe, chronic, highly debilitating, and often present in early childhood. Finding a treatment for a rare disease is challenging. Thanks to incentives that encourage research and development programs in rare diseases, several orphan drugs are currently available. The elevated cost of orphan drugs is a highly debated issue and a cause of limited access to treatment for many patients. As patent protection and the exclusivity period of several orphan drugs will expire soon, generic versions of orphan drugs should reach the market shortly, with great expectations about their impact on the economic burden of rare diseases. However, consistent with other complex diseases, generic substitution may require thoughtful considerations and may be even contraindicated in some rare conditions. This article provides an overview of rare disease characteristics, reviews reports of problematic generic substitution, and discusses why generic substitution of orphan drugs may be challenging and should be undertaken carefully in rare disease patients.

Perceptions and utilization of generic medicines in Guatemala: a mixed-methods study with physicians and pharmacy staff.

PubMed

Flood, David; Mathieu, Irène; Chary, Anita; García, Pablo; Rohloff, Peter

2017-01-13

Access to low-cost essential generic medicines is a critical health policy goal in low-and-middle income countries (LMICs). Guatemala is an LMIC where there is both limited availability and affordability of these medications. However, attitudes of physicians and pharmacy staff regarding low-cost generics, especially generics for non-communicable diseases (NCDs), have not been fully explored in Guatemala. Semi-structured interviews with 30 pharmacy staff and 12 physicians in several highland towns in Guatemala were conducted. Interview questions related to perceptions of low-cost generic medicines, prescription and dispensing practices of generics in the treatment of two NCDs, diabetes and hypertension, and opinions about the roles of pharmacy staff and physicians in selecting medicines for patients. Pharmacy staff were recruited from a random sample of pharmacies and physicians were recruited from a convenience sample. Interview data were analyzed using a thematic approach for qualitative data as well as basic quantitative statistics. Pharmacy staff and physicians expressed doubt as to the safety and efficacy of low-cost generic medicines in Guatemala. The low cost of generic medicines was often perceived as proof of their inferior quality. In the case of diabetes and hypertension, the decision to utilize a generic medicine was based on multiple factors including the patient's financial situation, consumer preference, and, to a large extent, physician recommendations. Interventions to improve generic medication utilization in Guatemala must address the negative perceptions of physicians and pharmacy staff toward low-cost generics. Strengthening state capacity and transparency in the regulation and monitoring of the drug supply is a key goal of access-to-medicines advocacy in Guatemala.

Pharmacists' experiences and attitudes regarding generic drugs and generic substitution: two sides of the coin.

PubMed

Olsson, Erika; Kälvemark Sporrong, Sofia

2012-12-01

Generic drug substitution reduces costs for medicines, but the downsides include unintentional double medication, confusion and anxiety among patients. Information from pharmacists affects patients' experiences of substitution with generic drugs. The aim of this study was to explore experiences and attitudes to generic substitution among Swedish community pharmacists. An interview guide was developed. Semi-structured interviews with community pharmacists were conducted and transcribed verbatim. Analysis was inductive; extracts from the transcripts were compared and combined to form themes and subcategories. Pharmacists from a heterogeneous convenience sample of pharmacies were interviewed until data saturation had been achieved. Sixteen pharmacists were interviewed. Three main themes and twelve subcategories were identified, with the main themes being the role of the pharmacist, pharmacists' concerns regarding patients, and the generic drug. Pharmacists found it positive that generic substitution decreases the costs for pharmaceuticals but also emphasized that the switch can confuse and worry patients, which could result in less benefit from treatment. Respondents claimed that generic substitution has changed the focus in the pharmacist-patient meeting towards economics and regulations. According to the interviewed pharmacists generic substitution is not primarily an issue of generic versus brand-name products, but concerns above all the challenges that the switch implies for patients and pharmacists. To prevent known confusion and concerns among patients it is important that community pharmacists acquire the necessary tools and knowledge to manage this situation; pharmacists themselves as well as pharmacy owners and authorities share responsibility for this. © 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.

Scale in Remote Sensing and GIS: An Advancement in Methods Towards a Science of Scale

NASA Technical Reports Server (NTRS)

Quattrochi, Dale A.

1998-01-01

The term "scale", both in space and time, is central to remote sensing and geographic information systems (GIS). The emergence and widespread use of GIS technologies, including remote sensing, has generated significant interest in addressing scale as a generic topic, and in the development and implementation of techniques for dealing explicitly with the vicissitudes of scale as a multidisciplinary issue. As science becomes more complex and utilizes databases that are capable of performing complex space-time data analyses, it becomes paramount that we develop the tools and techniques needed to operate at multiple scales, to work with data whose scales are not necessarily ideal, and to produce results that can be aggregated or disaggregated in ways that suit the decision-making process. Contemporary science is constantly coping with compromises, and the data available for a particular study rarely fit perfectly with the scales at which the processes being investigated operate, or the scales that policy-makers require to make sound, rational decisions. This presentation discusses some of the problems associated with scale as related to remote sensing and GIS, and describes some of the questions that need to be addressed in approaching the development of a multidisciplinary "science of scale". Techniques for dealing with multiple scaled data that have been developed or explored recently are described as a means for recognizing scale as a generic issue, along with associated theory and tools that can be of simultaneous value to a large number of disciplines. These can be used to seek answers to a host of interrelated questions in the interest of providing a formal structure for the management and manipulation of scale and its universality as a key concept from a multidisciplinary perspective.

Scale in Remote Sensing and GIS: An Advancement in Methods Towards a Science of Scale

NASA Technical Reports Server (NTRS)

Quattrochi, D. A.

1998-01-01

The term "scale", both in space and time, is central to remote sensing and Geographic Information Systems (GIS). The emergence and widespread use of GIS technologies, including remote sensing, has generated significant interest in addressing scale as a generic topic, and in the development and implementation of techniques for dealing explicitly with the vicissitudes of scale as a multidisciplinary issue. As science becomes more complex and utilizes databases that are capable of performing complex space-time data analyses, it becomes paramount that we develop the tools and techniques needed to operate at multiple scales, to work with data whose scales are not necessarily ideal, and to produce results that can be aggregated or disaggregated ways that suit the decision-making process. Contemporary science is constantly coping with compromises, and the data available for a particular study rarely fit perfectly with the scales at which the processes being investigated operate, or the scales that policy-makers require to make sound, rational decisions. This presentation discusses some of the problems associated with scale as related to remote sensing and GIS, and describes some of the questions that need to be addressed in approaching the development of a multidisciplinary "science of scale". Techniques for dealing with multiple scaled data that have been developed or explored recently are described as a means for recognizing scale as a generic issue, along with associated theory and tools that can be of simultaneous value to a large number of disciplines. These can be used to seek answers to a host of interrelated questions in the interest of providing a formal structure for the management and manipulation of scale and its universality as a key concept from a multidisciplinary perspective.

Biosimilar safety considerations in clinical practice.

PubMed

Choy, Edwin; Jacobs, Ira Allen

2014-02-01

Biologics are important treatments for a number of cancers. Patents for several biologics will expire over the next decade, removing a barrier to the development and commercialization of biosimilars. As biologics differ from small-molecule drugs due to their size and complexity, multifaceted manufacturing process, and their potential for immunogenicity, biosimilars cannot be considered "generic versions" of currently approved biologics. In highly regulated markets, biosimilars can be authorized only if they are demonstrated to be highly similar to the original drug from an analytical and clinical perspective. Any differences must be justified and shown to have no clinically meaningful effect on the safety and efficacy of the biosimilar. The European Medicines Agency has approved a number of biosimilars and the recent approval of the biosimilar infliximab monoclonal antibody is another regulatory milestone. This article will provide context regarding key safety issues addressed in biosimilar development, approval, and delivery, as well as inform oncologists on matters of safety to consider when prescribing biosimilars. Pertinent issues about safety from countries or regions where biosimilars are currently in use also will be reviewed. © 2014 Elsevier Inc. All rights reserved.

Humans, 'things' and space: costing hospital infection control interventions.

PubMed

Page, K; Graves, N; Halton, K; Barnett, A G

2013-07-01

Previous attempts at costing infection control programmes have tended to focus on accounting costs rather than economic costs. For studies using economic costs, estimates tend to be quite crude and probably underestimate the true cost. One of the largest costs of any intervention is staff time, but this cost is difficult to quantify and has been largely ignored in previous attempts. To design and evaluate the costs of hospital-based infection control interventions or programmes. This article also discusses several issues to consider when costing interventions, and suggests strategies for overcoming these issues. Previous literature and techniques in both health economics and psychology are reviewed and synthesized. This article provides a set of generic, transferable costing guidelines. Key principles such as definition of study scope and focus on large costs, as well as pitfalls (e.g. overconfidence and uncertainty), are discussed. These new guidelines can be used by hospital staff and other researchers to cost their infection control programmes and interventions more accurately. Copyright © 2013 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Knowledge, attitudes, and practices of community pharmacists on generic medicines in Qatar.

PubMed

Awaisu, Ahmed; Kheir, Nadir; Ibrahim, Mohamed Izham Mohamed; El-Hajj, Maguy; Hazi, Huda; Khudair, Nada; Barazi, Raja

2014-04-01

The practice of generic medicines prescribing, dispensing and substitution in developing countries has been controversial among healthcare professionals, particularly due to issues on quality, safety and efficacy. These controversies are as a result of inter-country differences in policies and laws as well as individualized knowledge and attitudes of pharmacists pertaining to generic medicines. This study primarily aims to assess the knowledge, attitudes, and practices of community pharmacists in Qatar towards generic medicines. Community pharmacy settings throughout the State of Qatar. A cross-sectional study using a pretested paper-based survey was conducted among a random sample of community pharmacists in Qatar. The data were analyzed using IBM-SPSS(®) version 20. Both descriptive and inferential statistical analyses were applied. Knowledge, attitudes, and practices of generic medicines pertaining to regulatory standards, safety, efficacy, quality, and future policies. Results A total of 160 surveys were distributed to community pharmacists of which 118 were returned (response rate, 74 %). The mean total score of generic medicines knowledge among the pharmacists was 6.8 ± 1.6 (maximum possible score was 10). Years of practice as well as place of obtaining academic degree did not influence knowledge score. Approximately 72 % of the pharmacists supported generic substitution for brand name drugs in all cases where a generic medicine is available and the majority (93 %) agreed that pharmacists should be given generic substitution right. Nearly 61 % of the pharmacists considered lack of proven bioequivalence to original brands as an important barrier for selecting generic medicines and 55 % rated "lack of policy for directing the practice of generic medicine" as an important barrier. In order to enhance the quality use of and to promote the practice of generic medicines in Qatar, an educational program should be implemented. A national generic medicine policy and guidelines are warranted in the State of Qatar.

75 FR 57537 - Sunshine Act; Notice of Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-21

..., 2010 9:30 a.m. Briefing on Security Issues (Closed--Ex. 1). * * * * * * The schedule for Commission..., 2010 1 p.m. Briefing on Resolution of Generic Safety Issue (GSI)--191, Assessment of Debris... 18, 2010 1:30 p.m. NRC All Employees Meeting (Public Meeting) Marriott Bethesda North Hotel, 5701...

Solving the Software Legacy Problem with RISA

NASA Astrophysics Data System (ADS)

Ibarra, A.; Gabriel, C.

2012-09-01

Nowadays hardware and system infrastructure evolve on time scales much shorter than the typical duration of space astronomy missions. Data processing software capabilities have to evolve to preserve the scientific return during the entire experiment life time. Software preservation is a key issue that has to be tackled before the end of the project to keep the data usable over many years. We present RISA (Remote Interface to Science Analysis) as a solution to decouple data processing software and infrastructure life-cycles, using JAVA applications and web-services wrappers to existing software. This architecture employs embedded SAS in virtual machines assuring a homogeneous job execution environment. We will also present the first studies to reactivate the data processing software of the EXOSAT mission, the first ESA X-ray astronomy mission launched in 1983, using the generic RISA approach.

A Generic Framework of Performance Measurement in Networked Enterprises

NASA Astrophysics Data System (ADS)

Kim, Duk-Hyun; Kim, Cheolhan

Performance measurement (PM) is essential for managing networked enterprises (NEs) because it greatly affects the effectiveness of collaboration among members of NE.PM in NE requires somewhat different approaches from PM in a single enterprise because of heterogeneity, dynamism, and complexity of NE’s. This paper introduces a generic framework of PM in NE (we call it NEPM) based on the Balanced Scorecard (BSC) approach. In NEPM key performance indicators and cause-and-effect relationships among them are defined in a generic strategy map. NEPM could be applied to various types of NEs after specializing KPIs and relationships among them. Effectiveness of NEPM is shown through a case study of some Korean NEs.

Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? Findings from across Europe and their implications.

PubMed

Godman, Brian; Petzold, Max; Bennett, Kathleen; Bennie, Marion; Bucsics, Anna; Finlayson, Alexander E; Martin, Andrew; Persson, Marie; Piessnegger, Jutta; Raschi, Emanuel; Simoens, Steven; Zara, Corinne; Barbui, Corrado

2014-06-13

Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments. Consequently, generally there have been limited demand-side measures by health authorities to encourage the preferential prescribing of generics. This is unlike the situation with hypertension, hypercholaesterolaemia or acid-related stomach disorders.The objectives of this study were to compare the effect of the limited demand-side measures in Western European countries and regions on the subsequent prescribing of risperidone following generics; to utilise the findings to provide future guidance to health authorities; and where possible, to investigate the utilisation of generic versus originator risperidone and the prices for generic risperidone. Principally, this was a segmented regression analysis of retrospective time-series data of the effect of the various initiatives in Belgium, Ireland, Scotland and Sweden following the introduction of generic risperidone. The study included patients prescribed at least one atypical antipsychotic drug up to 20 months before and up to 20 months after generic risperidone. In addition, retrospective observational studies were carried out in Austria and Spain (Catalonia) from 2005 to 2011 as well as one English primary care organisation (Bury Primary Care Trust (PCT)). There was a consistent steady reduction in risperidone as a percentage of total selected atypical antipsychotic utilisation following generics. A similar pattern was seen in Austria and Spain, with stable utilisation in one English PCT. However, there was considerable variation in the utilisation of generic risperidone, ranging from 98% of total risperidone in Scotland to only 14% in Ireland. Similarly, the price of generic risperidone varied considerably. In Scotland, generic risperidone was only 16% of pre-patent loss prices versus 72% in Ireland. Consistent findings of no increased prescribing of risperidone post generics with limited specific demand-side measures suggests no 'spillover' effect from one class to another encouraging the preferential prescribing of generic atypical antipsychotic drugs. This is exacerbated by the complexity of the disease area and differences in the side-effects between treatments. There appeared to be no clinical issues with generic risperidone, and prices inversely reflected measures to enhance their utilisation.

Affordable antiretroviral drugs for the under-served markets: how to expand equitable access against the backdrop of challenging scenarios?

PubMed

Dionisio, Daniele; Cao, Yunzhen; Hongzhou, Lu; Kraisintu, Krisana; Messeri, Daniela

2006-01-01

Threats by enforced Intellectual Property (IP) rights to equitable HIV treatment access by poor populations are impending. India and China's policy directions in the field will be crucial in ultimately affecting the affordability and accessibility of antiretroviral (ARV) therapy in the under-served markets. These directions, together with the exploitation level of IP-bound flexibilities and the evolutionary modelling in partnerships and trade agreements between research-based and generic pharmaceutical industry, will also affect the outcomes of self-sufficiency efforts now at their beginning in the developing world as far as domestic manufacturing of generic ARV drugs is concerned. This paper explores key issues, implications and interaction dynamics across these challenging scenarios while attempting to provide equitable solution glimpses into the near future. Access-oriented long-term drug policy strategies entitled to pass muster of governments, research-based as well as generic industries in both developed and developing countries are needed if equitable access to affordable ARV treatments by poor people has to be achieved despite enforced IP rights. Predictable dynamics between western multinationals and transitional country generic corporations let regard IP-bound Voluntary License flexibilities as a fitting measure into just mentioned needs especially if substantial incentives to generic corporations are concurrently secured. Efforts to equitably expand ARV drug access through exploiting IP opportunities should encompass attainment of self-sufficiency in domestic drug manufacturing whenever basic requirements are in place in the developing world as a whole. A credible industrial potential would act, indeed, as a boosting factor for drawing branded drug producers into technology transfer agreements, the terms of which would let all contractors enjoy substantial advantages. These perspectives consistently bind up with the foreseeable long-term trade and drug policy directions of India and China according to frontier crossing implications of their key IP management trends as well as their multifaceted penetration strategies of both the wealthy and under-served markets worldwide. As coherent with these perspectives, more disbursement by wealthy country governments and donors to basic infrastructure development in sub-Saharan African nations with stable governments in place is urged both as a priority for improving Africa's economy and a prerequisite for allowing domestic industrial plants to take off. Aiming at the targets just underscored, WHO's brokering role in negotiated agreements between wealthy and developing country-based firms as well as its technical guidance in setting international standards have always to be sought if equitable and appropriate end results are to be attained. Overall insights in this paper would mean that, while research-based corporations are to be praised whenever waiving, on humanitarian purposes, part of their profits, the trade and profit rules cannot basically be given up if long-term sustainable results are the goal to look for. Only negotiated agreements securing all contracting parties lasting advantages may ensure shifting of such a goal from mere vision to a really sustainable attainment.

The Environmental Protection Agency's Safety Standards for Disposal of Spent Nuclear Fuel: Potential Path Forward in Response to the Report of the Blue Ribbon Commission on America's Nuclear Future - 13388

DOE Office of Scientific and Technical Information (OSTI.GOV)

Forinash, Betsy; Schultheisz, Daniel; Peake, Tom

2013-07-01

Following the decision to withdraw the Yucca Mountain license application, the Department of Energy created a Blue Ribbon Commission (BRC) on America's Nuclear Future, tasked with recommending a national strategy to manage the back end of the nuclear fuel cycle. The BRC issued its final report in January 2012, with recommendations covering transportation, storage and disposal of spent nuclear fuel (SNF); potential reprocessing; and supporting institutional measures. The BRC recommendations on disposal of SNF and high-level waste (HLW) are relevant to the U.S. Environmental Protection Agency (EPA), which shares regulatory responsibility with the Nuclear Regulatory Commission (NRC): EPA issues 'generallymore » applicable' performance standards for disposal repositories, which are then implemented in licensing. For disposal, the BRC endorses developing one or more geological repositories, with siting based on an approach that is adaptive, staged and consent-based. The BRC recommends that EPA and NRC work cooperatively to issue generic disposal standards-applying equally to all sites-early in any siting process. EPA previously issued generic disposal standards that apply to all sites other than Yucca Mountain. However, the BRC concluded that the existing regulations should be revisited and revised. The BRC proposes a number of general principles to guide the development of future regulations. EPA continues to review the BRC report and to assess the implications for Agency action, including potential regulatory issues and considerations if EPA develops new or revised generic disposal standards. This review also involves preparatory activities to define potential process and public engagement approaches. (authors)« less

The Spatial Vision Tree: A Generic Pattern Recognition Engine- Scientific Foundations, Design Principles, and Preliminary Tree Design

NASA Technical Reports Server (NTRS)

Rahman, Zia-ur; Jobson, Daniel J.; Woodell, Glenn A.

2010-01-01

New foundational ideas are used to define a novel approach to generic visual pattern recognition. These ideas proceed from the starting point of the intrinsic equivalence of noise reduction and pattern recognition when noise reduction is taken to its theoretical limit of explicit matched filtering. This led us to think of the logical extension of sparse coding using basis function transforms for both de-noising and pattern recognition to the full pattern specificity of a lexicon of matched filter pattern templates. A key hypothesis is that such a lexicon can be constructed and is, in fact, a generic visual alphabet of spatial vision. Hence it provides a tractable solution for the design of a generic pattern recognition engine. Here we present the key scientific ideas, the basic design principles which emerge from these ideas, and a preliminary design of the Spatial Vision Tree (SVT). The latter is based upon a cryptographic approach whereby we measure a large aggregate estimate of the frequency of occurrence (FOO) for each pattern. These distributions are employed together with Hamming distance criteria to design a two-tier tree. Then using information theory, these same FOO distributions are used to define a precise method for pattern representation. Finally the experimental performance of the preliminary SVT on computer generated test images and complex natural images is assessed.

International Solar-Terrestrial Program Key Parameter Visualization Tool Data: USA_NASA_DDF_ISTP_IM_KP_0161

NASA Technical Reports Server (NTRS)

Ocuna, M. H.; Ogilvie, K. W.; Baker, D. N.; Curtis, S. A.; Fairfield, D. H.; Mish, W. H.

2000-01-01

The Global Geospace Science Program (GGS) is designed to improve greatly the understanding of the flow of energy, mass and momentum in the solar-terrestrial environment with particular emphasis on "Geospace". The Global Geospace Science Program is the US contribution to the International Solar-Terrestrial Physics (ISTP) Science Initiative. This CD-ROM issue describes the WIND and POLAR spacecraft, the scientific experiments carried onboard, the Theoretical and Ground Based investigations which constitute the US Global Geospace Science Program and the ISTP Data Systems which support the data acquisition and analysis effort. The International Solar-Terrestrial Physics Program (ISTP) Key Parameter Visualization Tool (KPVT), provided on the CD-ROM, was developed at the ISTP Science Planning and Operations Facility (SPOF). The KPVT is a generic software package for visualizing the key parameter data produced from all ISTP missions, interactively and simultaneously. The tool is designed to facilitate correlative displays of ISTP data from multiple spacecraft and instruments, and thus the selection of candidate events and data quality control. The software, written in IDL, includes a graphical/widget user interface, and runs on many platforms, including various UNIX workstations, Alpha/Open VMS, Macintosh (680x0 and PowerPC), and PC/Windows NT, Windows 3.1, and Windows 95.

International Solar-Terrestrial Program Key Parameter Visualization Tool Data: USA_NASA_DDF_ISTP_KP_0192

NASA Technical Reports Server (NTRS)

Ocuna, M. H.; Ogilvie, K. W.; Baker, D. N.; Curtis, S. A.; Fairfield, D. H.; Mish, W. H.

2001-01-01

The Global Geospace Science Program (GGS) is designed to improve greatly the understanding of the flow of energy, mass and momentum in the solar-terrestrial environment with particular emphasis on "Geospace". The Global Geospace Science Program is the US contribution to the International Solar-Terrestrial Physics (ISTP) Science Initiative. This CD-ROM issue describes the WIND and POLAR spacecraft, the scientific experiments carried onboard, the Theoretical and Ground Based investigations which constitute the US Global Geospace Science Program and the ISTP Data Systems which support the data acquisition and analysis effort. The International Solar-Terrestrial Physics Program (ISTP) Key Parameter Visualization Tool (KPVT), provided on the CD-ROM, was developed at the ISTP Science Planning and Operations Facility (SPOF). The KPVT is a generic software package for visualizing the key parameter data produced from all ISTP missions, interactively and simultaneously. The tool is designed to facilitate correlative displays of ISTP data from multiple spacecraft and instruments, and thus the selection of candidate events and data quality control. The software, written in IDL, includes a graphical/widget user interface, and runs on many platforms, including various UNIX workstations, Alpha/Open VMS, Macintosh (680x0 and PowerPC), and PC/Windows NT, Windows 3.1, and Windows 95.

International Solar-Terrestrial Program Key Parameter Visualization Tool Data: USA_NASA_DDF_ISTP_KP_0139

NASA Technical Reports Server (NTRS)

Ocuna, M. H.; Ogilvie, K. W.; Baker, D. N.; Curtis, S. A.; Fairfield, D. H.; Mish, W. H.

1999-01-01

The Global Geospace Science Program (GGS) is designed to improve greatly the understanding of the flow of energy, mass and momentum in the solar-terrestrial environment with particular emphasis on "Geospace". The Global Geospace Science Program is the US contribution to the International Solar-Terrestrial Physics (ISTP) Science Initiative. This CD-ROM issue describes the WIND and POLAR spacecraft, the scientific experiments carried onboard, the Theoretical and Ground Based investigations which constitute the US Global Geospace Science Program and the ISTP Data Systems which support the data acquisition and analysis effort. The International Solar-Terrestrial Physics Program (ISTP) Key Parameter Visualization Tool (KPVT), provided on the CD-ROM, was developed at the ISTP Science Planning and Operations Facility (SPOF). The KPVT is a generic software package for visualizing the key parameter data produced from all ISTP missions, interactively and simultaneously. The tool is designed to facilitate correlative displays of ISTP data from multiple spacecraft and instruments, and thus the selection of candidate events and data quality control. The software, written in IDL, includes a graphical/widget user interface, and runs on many platforms, including various UNIX workstations, Alpha/Open VMS, Macintosh (680x0 and PowerPC), and PC/Windows NT, Windows 3.1, and Windows 95.

International Solar-Terrestrial Program Key Parameter Visualization Tool Data: USA_NASA_DDF_ISTP_IM_KP_0185

NASA Technical Reports Server (NTRS)

Ocuna, M. H.; Ogilvie, K. W.; Baker, D. N.; Curtis, S. A.; Fairfield, D. H.; Mish, W. H.

2000-01-01

The Global Geospace Science Program (GGS) is designed to improve greatly the understanding of the flow of energy, mass and momentum in the solar-terrestrial environment with particular emphasis on "Geospace". The Global Geospace Science Program is the US contribution to the International Solar-Terrestrial Physics (ISTP) Science Initiative. This CD-ROM issue describes the WIND and POLAR spacecraft, the scientific experiments carried onboard, the Theoretical and Ground Based investigations which constitute the US Global Geospace Science Program and the ISTP Data Systems which support the data acquisition and analysis effort. The International Solar-Terrestrial Physics Program (ISTP) Key Parameter Visualization Tool (KPVT), provided on the CD-ROM, was developed at the ISTP Science Planning and Operations Facility (SPOF). The KPVT is a generic software package for visualizing the key parameter data produced from all ISTP missions, interactively and simultaneously. The tool is designed to facilitate correlative displays of ISTP data from multiple spacecraft and instruments, and thus the selection of candidate events and data quality control. The software, written in IDL, includes a graphical/widget user interface, and runs on many platforms, including various UNIX workstations, Alpha/Open VMS, Macintosh (680x0 and PowerPC), and PC/Windows NT, Windows 3.1, and Windows 95.

A comparative analysis of generics markets in five European countries.

PubMed

Garattini, L; Tediosi, F

2000-04-01

A generic medicine is a faithful copy of a mature drug--no longer under patent marketed with the chemical name of the active ingredient. This article analyses generics markets in five European countries: France, Germany Italy, The Netherlands and the U.K. The study investigate all the main issues--patent, approval to market, pricing and reimbursement, prescription and distribution--which affect the life cycle of a pharmaceutical product. The situation in the five countries varied widely. Because of European harmonization, patent legislation and approval procedures no longer affect much the development of generics. Only national legislation on patent protection approved before the EU directive came into force still plays a role. Approval differences seem to be due mainly to common practice, rather than to the regulations themselves. None of the countries have an efficient public information system on patent expiry. Generics have had more success in countries with more flexible pricing policies. Reimbursement has not yet been used widely to discriminate between generics and proprietary drugs. Financial incentives are based more on physicians' prescribing behaviour than on pharmacists. The freedom of pharmacy ownership and the consequent possibility of dispensing pharmaceuticals through different channels affects dramatically the structure of generics markets. A free market of wholesalers and retailers can enhance a comparative market, through horizontal and vertical integration all along the distribution chain. Such an environment has stimulate the success of unbranded generics by delegating strong purchasing power to distributors.

Devising and Implementing a Suitable Graduate Education Platform for Dublin's Institute of Technology (DIT)

ERIC Educational Resources Information Center

Carton, Janet; Jerrams, Steve

2008-01-01

Graduate education platforms have received general acclaim as key components in the future structural development of third-level and fourth-level education in Europe. In Ireland the Higher Education Authority (HEA) has endorsed the restructuring of postgraduate education to incorporate the training of research students in key generic and…

Generic phytosanitary irradiation treatments

NASA Astrophysics Data System (ADS)

Hallman, Guy J.

2012-07-01

The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies.

Generic products of antiepileptic drugs: a perspective on bioequivalence, bioavailability, and formulation switches using Monte Carlo simulations.

PubMed

Karalis, Vangelis; Macheras, Panos; Bialer, Meir

2014-01-01

Generic products of antiepileptic drugs (AEDs) are currently a controversial topic as neurologists and patients are reluctant to switch from brand products to generics and to switch between generics. The aim of this study was to provide enlightenment on issues of bioequivalence (BE) and interchangeability of AED products. Monte Carlo simulations of the classic 2 × 2 BE studies were performed to study the effect of sample size, within-subject variability, and the true difference in pharmacokinetic values of the products under comparison on BE acceptance of generic AED products. Simulations were extended to study the comparative performance of two generic AED products against the same innovative product. The simulated results are compared with literature data on AEDs. The question with regard to bioavailability (BA) is whether two formulations are different, while for BE the question is whether two formulations are sufficiently similar in terms of extent and rate of absorption. Therefore, the criteria for BA and BE and the statistical analysis involved in their analysis are different. Two generic formulations that meet regulatory approval requirements for generics by being bioequivalent to the same innovative AED may not be bioequivalent to one another and therefore should not be regarded as equal or as therapeutically equivalent products. A switch from a standard or an immediate-release formulation to a modified-release product, which comprises extended-release or delayed-release formulations, should not be regarded as a switch between generics, but rather as a switch between different formulation types. Switches between bioequivalent generic AED products could potentially lead to larger changes in plasma levels and exposure than the brand-to-generic switch. The simulation work verified the clinical findings that not all generic AED products bioequivalent to the same innovative product are bioequivalent to one another. Two generic formulations that meet regulatory approval requirements for generics, by being bioequivalent to the innovative AED, may not be bioequivalent to one another. Additional BE criteria are needed for a formulation switch, particularly in epilepsy, where a breakthrough seizure may change a patient's status from seizure-free to refractory.

Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the USA and the EU.

PubMed

Conti, Rena M; Padula, William V; Larson, Richard A

2015-04-01

Imatinib is an oral tyrosine kinase inhibitor and considered to be the most successful targeted anti-cancer agent yet developed given its substantial efficacy in treating chronic myeloid leukemia (CML) and other malignant diseases. In the USA and the European Union (EU), Novartis' composition of matter patent on imatinib will expire in 2016. The potential impact on health system spending levels for CML after generic imatinib becomes available is the subject of significant interest among stakeholders. The extent of the potential savings largely depends on whether and to what extent prices decline and use stays the same or even increases. These are also empirical questions since the likely spending implications following generic imatinib's availability are predicated on multiple factors: physicians' willingness to prescribe generic imatinib, molecule characteristics, and health system priorities. This article discusses each of these issues in turn. We then review their implications for the development of country-specific cost-effectiveness models to predict the implications for cost and quality of care from generic imatinib.

Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the USA and the EU

PubMed Central

Padula, William V.; Larson, Richard A.

2015-01-01

Imatinib is an oral tyrosine kinase inhibitor and considered to be the most successful targeted anti-cancer agent yet developed given its substantial efficacy in treating chronic myeloid leukemia (CML) and other malignant diseases. In the USA and the European Union (EU), Novartis’ composition of matter patent on imatinib will expire in 2016. The potential impact on health system spending levels for CML after generic imatinib becomes available is the subject of significant interest among stakeholders. The extent of the potential savings largely depends on whether and to what extent prices decline and use stays the same or even increases. These are also empirical questions since the likely spending implications following generic imatinib’s availability are predicated on multiple factors: physicians’ willingness to prescribe generic imatinib, molecule characteristics, and health system priorities. This article discusses each of these issues in turn. We then review their implications for the development of country-specific cost-effectiveness models to predict the implications for cost and quality of care from generic imatinib. PMID:25814091

Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA.

PubMed

Bate, Roger; Mathur, Aparna; Lever, Harry M; Thakur, Dinesh; Graedon, Joe; Cooperman, Tod; Mason, Preston; Fox, Erin R

2016-03-01

The regulations for assessing the quality of generic drugs and their bioequivalence to innovator products are outdated and need to be substantially modernized. There are multiple reasons why these changes are needed, including: (i) the regulations remain largely unchanged since the passage of the Hatch-Waxman Act in 1984; (ii) medication therapies have become substantially more complex over the three decades since the passage of the Act; (iii) a switch from an innovator drug to a generic drug, or switching from one generic to another, is not a benign process - there is substantial clinical professional judgment involved and in some instances these decisions should be better informed; and (iv) pharmaceutical ingredients for finished products, whether innovator or generic, are from multiple sources of supply, adding variability in their production, and which may not be accounted for in specification tolerances. When these elements are viewed together, they clearly suggest that more transparency of responsible manufacturers in product labels and updated standards for bioequivalence are required. Copyright © 2015 Elsevier Ltd. All rights reserved.

Rural Special Education Quarterly, Volume 5, Nos. 1-4, Spring-Fall 1984, Winter 1985.

ERIC Educational Resources Information Center

Rural Special Education Quarterly, 1985

1985-01-01

Four newsletter issues examine aspects of rural special education. Issue number one considers the generic problems or solutions in rural special education leadership, the need for innovative preservice preparation for rural educators, preservice training for Native American professionals and paraprofessionals, a model for rural early intervention,…

Student Press in American Archives, Fall/Winter 1973-74.

ERIC Educational Resources Information Center

National Council of Coll. Publications Advisers.

This issue of the "Student Press in America Archives List" contains 100 entries on current issues and information, as well as cases involving student press editors, advisers, student media, and the generic subject of the campus press, emphasizing censorship practices and principles. Information concerning how and where to obtain documents of…

From theory to 'measurement' in complex interventions: methodological lessons from the development of an e-health normalisation instrument.

PubMed

Finch, Tracy L; Mair, Frances S; O'Donnell, Catherine; Murray, Elizabeth; May, Carl R

2012-05-17

Although empirical and theoretical understanding of processes of implementation in health care is advancing, translation of theory into structured measures that capture the complex interplay between interventions, individuals and context remain limited. This paper aimed to (1) describe the process and outcome of a project to develop a theory-based instrument for measuring implementation processes relating to e-health interventions; and (2) identify key issues and methodological challenges for advancing work in this field. A 30-item instrument (Technology Adoption Readiness Scale (TARS)) for measuring normalisation processes in the context of e-health service interventions was developed on the basis on Normalization Process Theory (NPT). NPT focuses on how new practices become routinely embedded within social contexts. The instrument was pre-tested in two health care settings in which e-health (electronic facilitation of healthcare decision-making and practice) was used by health care professionals. The developed instrument was pre-tested in two professional samples (N=46; N=231). Ratings of items representing normalisation 'processes' were significantly related to staff members' perceptions of whether or not e-health had become 'routine'. Key methodological challenges are discussed in relation to: translating multi-component theoretical constructs into simple questions; developing and choosing appropriate outcome measures; conducting multiple-stakeholder assessments; instrument and question framing; and more general issues for instrument development in practice contexts. To develop theory-derived measures of implementation process for progressing research in this field, four key recommendations are made relating to (1) greater attention to underlying theoretical assumptions and extent of translation work required; (2) the need for appropriate but flexible approaches to outcomes measurement; (3) representation of multiple perspectives and collaborative nature of work; and (4) emphasis on generic measurement approaches that can be flexibly tailored to particular contexts of study.

Brands or generics: the dilemma of pharmaceutical marketing in a developing country.

PubMed

Quraeshi, Z A; Luqmani, M; Malhotra, N

1983-01-01

A significant issue in pharmaceutical marketing in many developing countries is whether drugs should be sold by generic or by brand names. In Pakistan, legislation prohibited the sale of brand name drugs in order to increase price competition, and strengthen the market position of indigenous manufacturers to compete against multinationals. However, the government's objectives were not achieved for reasons discussed in the article. The Pakistan case has implications for multinational firms and for other developing countries in similar situations.

Generic guide concepts for the European Spallation Source

NASA Astrophysics Data System (ADS)

Zendler, C.; Martin Rodriguez, D.; Bentley, P. M.

2015-12-01

The construction of the European Spallation Source (ESS) faces many challenges from the neutron beam transport point of view: the spallation source is specified as being driven by a 5 MW beam of protons, each with 2 GeV energy, and yet the requirements in instrument background suppression relative to measured signal vary between 10-6 and 10-8. The energetic particles, particularly above 20 MeV, which are expected to be produced in abundance in the target, have to be filtered in order to make the beamlines safe, operational and provide good quality measurements with low background. We present generic neutron guides of short and medium length instruments which are optimised for good performance at minimal cost. Direct line of sight to the source is avoided twice, with either the first point out of line of sight or both being inside the bunker (20 m) to minimise shielding costs. These guide geometries are regarded as a baseline to define standards for instruments to be constructed at ESS. They are used to find commonalities and develop principles and solutions for common problems. Lastly, we report the impact of employing the over-illumination concept to mitigate losses from random misalignment passively, and that over-illumination should be used sparingly in key locations to be effective. For more widespread alignment issues, a more direct, active approach is likely to be needed.

From LCAs to simplified models: a generic methodology applied to wind power electricity.

PubMed

Padey, Pierryves; Girard, Robin; le Boulch, Denis; Blanc, Isabelle

2013-02-05

This study presents a generic methodology to produce simplified models able to provide a comprehensive life cycle impact assessment of energy pathways. The methodology relies on the application of global sensitivity analysis to identify key parameters explaining the impact variability of systems over their life cycle. Simplified models are built upon the identification of such key parameters. The methodology is applied to one energy pathway: onshore wind turbines of medium size considering a large sample of possible configurations representative of European conditions. Among several technological, geographical, and methodological parameters, we identified the turbine load factor and the wind turbine lifetime as the most influent parameters. Greenhouse Gas (GHG) performances have been plotted as a function of these key parameters identified. Using these curves, GHG performances of a specific wind turbine can be estimated, thus avoiding the undertaking of an extensive Life Cycle Assessment (LCA). This methodology should be useful for decisions makers, providing them a robust but simple support tool for assessing the environmental performance of energy systems.

Computational intelligence in earth sciences and environmental applications: issues and challenges.

PubMed

Cherkassky, V; Krasnopolsky, V; Solomatine, D P; Valdes, J

2006-03-01

This paper introduces a generic theoretical framework for predictive learning, and relates it to data-driven and learning applications in earth and environmental sciences. The issues of data quality, selection of the error function, incorporation of the predictive learning methods into the existing modeling frameworks, expert knowledge, model uncertainty, and other application-domain specific problems are discussed. A brief overview of the papers in the Special Issue is provided, followed by discussion of open issues and directions for future research.

The physical properties of generic latanoprost ophthalmic solutions are not identical.

PubMed

Kolko, Miriam; Koch Jensen, Peter

2017-06-01

To compare various characteristics of Xalatan ® and five generic latanoprost ophthalmic solutions. Drop size, volume, pH values, buffer capacity, viscosity, hardness of bottles and costs were determined. Drop sizes were measured in triplicates by micropipettes, and the number of drops counted in three separate bottles of each generic product was determined. pH values were measured in triplicates by a calibrated pH meter. Buffer capacity was exploited by titrating known quantities of strong base into 2.5 ml of each brand and interpolated to neutral pH. Kinematic viscosity was determined by linear regression of timed gravity flow from a vertical syringe through a 21-G cannula. The hardness of the bottles was evaluated by gradually increasing tension on a hook placed around each bottle until a drop was expelled reading the tension on an attached spring scale. Drop sizes and the number of drops in the bottles varied significantly between the generic drugs. The control value of pH in the brand version (Xalatan ® ) was markedly lower compared to the generic latanoprost products. Titration of Xalatan ® to neutrality required substantially more NaOH compared to the generic latanoprost products. Finally, the viscosity revealed a significant variability between brands. Remarkable differences were found in bottle shapes, bottle hardness and costs of the latanoprost generics. Generic latanoprost eye drops should not be considered identical to the original brand version as regards to drop size, volumes, pH values, buffer capacity, viscosity, hardness of bottles and costs. It is likely that these issues affect compliance and intraocular pressure (IOP)-lowering effect. Therefore, re-evaluation of the requirements for introducing generic eye drops seems reasonable. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Illustrative assessment of human health issues arising from the potential release of chemotoxic substances from a generic geological disposal facility for radioactive waste.

PubMed

Wilson, James C; Thorne, Michael C; Towler, George; Norris, Simon

2011-12-01

Many countries have a programme for developing an underground geological disposal facility for radioactive waste. A case study is provided herein on the illustrative assessment of human health issues arising from the potential release of chemotoxic and radioactive substances from a generic geological disposal facility (GDF) for radioactive waste. The illustrative assessment uses a source-pathway-receptor methodology and considers a number of human exposure pathways. Estimated exposures are compared with authoritative toxicological assessment criteria. The possibility of additive and synergistic effects resulting from exposures to mixtures of chemical contaminants or a combination of radiotoxic and chemotoxic substances is considered. The case study provides an illustration of how to assess human health issues arising from chemotoxic species released from a GDF for radioactive waste and highlights potential difficulties associated with a lack of data being available with which to assess synergistic effects. It also highlights how such difficulties can be addressed.

Potential Clinical and Economic Impact of Switching Branded Medications to Generics.

PubMed

Straka, Robert J; Keohane, Denis J; Liu, Larry Z

2017-05-01

Switching branded to generic medications has become a common cost-containment measure. Although this is an important objective for health care systems worldwide, the impact of this practice on patient outcomes needs to be carefully considered. We reviewed the literature summarizing the potential clinical and economic consequences of switching from branded to generic medications on patient outcomes. A literature search of peer-reviewed articles published 2003-2013 using key words of "generic switching" or "substitution" was conducted using PubMed, OvidSP, and ScienceDirect. Of 30 articles identified and reviewed, most were related to the diseases of the central nervous system, especially epilepsy. Based on our review, potential impacts of switching fell into 3 broad categories: patient attitudes and adherence, clinical and safety outcomes, and cost and resource utilization. Although in many cases generics may represent an appropriate alternative to branded products, this may not always be the case. Specifically, several studies suggested that switching may negatively impact medication adherence, whereas other studies found that generic switching was associated with poorer clinical outcomes and more adverse events. In some instances, switching accomplished cost savings but did so at increased total cost of care because of increased physician visits or hospitalizations. Although in many cases generics may represent an appropriate alternative, mandatory generic switching may lead to unintended consequences, especially in certain therapeutic areas. Although further study is warranted, based on our review, it may be medically justifiable for physicians and patients to retain the right to request the branded product in certain cases.

Potential Clinical and Economic Impact of Switching Branded Medications to Generics

PubMed Central

Straka, Robert J.; Keohane, Denis J.; Liu, Larry Z.

2017-01-01

Switching branded to generic medications has become a common cost-containment measure. Although this is an important objective for health care systems worldwide, the impact of this practice on patient outcomes needs to be carefully considered. We reviewed the literature summarizing the potential clinical and economic consequences of switching from branded to generic medications on patient outcomes. A literature search of peer-reviewed articles published 2003–2013 using key words of “generic switching” or “substitution” was conducted using PubMed, OvidSP, and ScienceDirect. Of 30 articles identified and reviewed, most were related to the diseases of the central nervous system, especially epilepsy. Based on our review, potential impacts of switching fell into 3 broad categories: patient attitudes and adherence, clinical and safety outcomes, and cost and resource utilization. Although in many cases generics may represent an appropriate alternative to branded products, this may not always be the case. Specifically, several studies suggested that switching may negatively impact medication adherence, whereas other studies found that generic switching was associated with poorer clinical outcomes and more adverse events. In some instances, switching accomplished cost savings but did so at increased total cost of care because of increased physician visits or hospitalizations. Although in many cases generics may represent an appropriate alternative, mandatory generic switching may lead to unintended consequences, especially in certain therapeutic areas. Although further study is warranted, based on our review, it may be medically justifiable for physicians and patients to retain the right to request the branded product in certain cases. PMID:26099048

The effects of workplace physical activity interventions in men: a systematic review.

PubMed

Wong, Jason Y L; Gilson, Nicholas D; van Uffelen, Jannique G Z; Brown, Wendy J

2012-07-01

The workplace is cited as a promising setting for physical activity (PA) promotion, but workplace PA interventions tend not to specifically target men. The aim of this article was to review the literature on workplace PA interventions for men and to identify key issues for future intervention development. Articles targeting PA at the workplace were located through a structured database search. Information on intervention strategies and PA outcomes were extracted. Only 13 studies (10.5%) reviewed focused on men, of which 5 showed significant increases in PA. These studies used generic, multicomponent, health promotion strategies with a variety of timeframes, self-report PA measures, and PA outcomes. The systematic review identified that evidence on the effectiveness of workplace PA interventions for men is equivocal and highlighted methodological concerns. Future research should use reliable and valid measures of PA and interventions that focus specifically on men's needs and PA preferences.

Hidden Order and Dimensional Crossover of the Charge Density Waves in TiSe 2

DOE PAGES

Chen, P.; Chan, Y. -H.; Fang, X. -Y.; ...

2016-11-29

Charge density wave (CDW) formation, a key physics issue for materials, arises from interactions among electrons and phonons that can also lead to superconductivity and other competing or entangled phases. The prototypical system TiSe 2, with a particularly simple (2 × 2 × 2) transition and no Kohn anomalies caused by electron-phonon coupling, is a fascinating but unsolved case after decades of research. Our angle-resolved photoemission measurements of the band structure as a function of temperature, aided by first-principles calculations, reveal a hitherto undetected but crucial feature: a (2 × 2) electronic order in each layer sets in at ~232more » K before the widely recognized three-dimensional structural order at ~205 K. The dimensional crossover, likely a generic feature of such layered materials, involves renormalization of different band gaps in two stages.« less

Modeling and Analysis of Multidiscipline Research Teams at NASA Langley Research Center: A Systems Thinking Approach

NASA Technical Reports Server (NTRS)

Waszak, Martin R.; Barthelemy, Jean-Francois; Jones, Kenneth M.; Silcox, Richard J.; Silva, Walter A.; Nowaczyk, Ronald H.

1998-01-01

Multidisciplinary analysis and design is inherently a team activity due to the variety of required expertise and knowledge. As a team activity, multidisciplinary research cannot escape the issues that affect all teams. The level of technical diversity required to perform multidisciplinary analysis and design makes the teaming aspects even more important. A study was conducted at the NASA Langley Research Center to develop a model of multidiscipline teams that can be used to help understand their dynamics and identify key factors that influence their effectiveness. The study sought to apply the elements of systems thinking to better understand the factors, both generic and Langley-specific, that influence the effectiveness of multidiscipline teams. The model of multidiscipline research teams developed during this study has been valuable in identifying means to enhance team effectiveness, recognize and avoid problem behaviors, and provide guidance for forming and coordinating multidiscipline teams.

A framework for service enterprise workflow simulation with multi-agents cooperation

NASA Astrophysics Data System (ADS)

Tan, Wenan; Xu, Wei; Yang, Fujun; Xu, Lida; Jiang, Chuanqun

2013-11-01

Process dynamic modelling for service business is the key technique for Service-Oriented information systems and service business management, and the workflow model of business processes is the core part of service systems. Service business workflow simulation is the prevalent approach to be used for analysis of service business process dynamically. Generic method for service business workflow simulation is based on the discrete event queuing theory, which is lack of flexibility and scalability. In this paper, we propose a service workflow-oriented framework for the process simulation of service businesses using multi-agent cooperation to address the above issues. Social rationality of agent is introduced into the proposed framework. Adopting rationality as one social factor for decision-making strategies, a flexible scheduling for activity instances has been implemented. A system prototype has been developed to validate the proposed simulation framework through a business case study.

An Integrated Academic Literacy Approach to Improving Students' Understanding of Plagiarism in an Accounting Course

ERIC Educational Resources Information Center

Powell, Lisa; Singh, Nishani

2016-01-01

Plagiarism in higher education is a widespread and complex issue. Students' understanding of plagiarism differs as a result of combining their prior learning about referencing with their current experience of institutional policies and generic resources. Plagiarism was identified as a major learning issue in a core second-year undergraduate…

A K-6 Computational Thinking Curriculum Framework: Implications for Teacher Knowledge

ERIC Educational Resources Information Center

Angeli, Charoula; Voogt, Joke; Fluck, Andrew; Webb, Mary; Cox, Margaret; Malyn-Smith, Joyce; Zagami, Jason

2016-01-01

Adding computer science as a separate school subject to the core K-6 curriculum is a complex issue with educational challenges. The authors herein address two of these challenges: (1) the design of the curriculum based on a generic computational thinking framework, and (2) the knowledge teachers need to teach the curriculum. The first issue is…

Distributive justice and the introduction of generic medicines.

PubMed

Rego, Guilhermina; Brandão, Cristina; Melo, Helena; Nunes, Rui

2002-01-01

All countries face the issue of choice in healthcare. Allocation of healthcare resources is clearly associated with the concept of distributive justice and to the existence of a right to healthcare. Nevertheless, there is still the question of whether this right should include all types of healthcare services or if it should be limited to selected types. It follows that choices must be made, priorities must be set and that efficiency of healthcare services should be maximum. Distributive justice aims at ensuring that everyone has access to necessary care based on the substantive ethical principles of equity and solidarity. Resource allocation is paramount in public policy particularly with regards pharmacoeconomics. The objective of this study is to determine the leading issues regarding the marketing and trade of generic medicines analysing the reasons why there are huge disparities between European countries with regards generic drugs acceptance by practitioners. Distributive justice aims at ensuring that everyone has access to reasonable care based on the ethical principles of equity and solidarity. However, universality implies always choice in access and efficiency in delivery. It follows that resource allocation is instrumental in public policy particularly with regards pharmacoeconomics. The acceptance of distributive justice as a new ethical paradigm for professional ethics implies that as long as the best interest of the patient is not at stake physicians should regard the use of generic drugs as a valid instrument to promote the efficiency of the system and therefore as a way to facilitate citizen's global access to healthcare.

Nuclear power plant Generic Aging Lessons Learned (GALL). Main report and appendix A

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kaza, K.E.; Diercks, D.R.; Holland, J.W.

The purpose of this generic aging lessons learned (GALL) review is to provide a systematic review of plant aging information in order to assess materials and component aging issues related to continued operation and license renewal of operating reactors. Literature on mechanical, structural, and thermal-hydraulic components and systems reviewed consisted of 97 Nuclear Plant Aging Research (NPAR) reports, 23 NRC Generic Letters, 154 Information Notices, 29 Licensee Event Reports (LERs), 4 Bulletins, and 9 Nuclear Management and Resources Council Industry Reports (NUMARC IRs) and literature on electrical components and systems reviewed consisted of 66 NPAR reports, 8 NRC Generic Letters,more » 111 Information Notices, 53 LERs, 1 Bulletin, and 1 NUMARC IR. More than 550 documents were reviewed. The results of these reviews were systematized using a standardized GALL tabular format and standardized definitions of aging-related degradation mechanisms and effects. The tables are included in volume s 1 and 2 of this report. A computerized data base has also been developed for all review tables and can be used to expedite the search for desired information on structures, components, and relevant aging effects. A survey of the GALL tables reveals that all ongoing significant component aging issues are currently being addressed by the regulatory process. However, the aging of what are termed passive components has been highlighted for continued scrutiny. This document is Volume 1, consisting of the executive summary, summary and observations, and an appendix listing the GALL literature review tables.« less

The Need and Keys for a New Generation Network Adjustment Software

NASA Astrophysics Data System (ADS)

Colomina, I.; Blázquez, M.; Navarro, J. A.; Sastre, J.

2012-07-01

Orientation and calibration of photogrammetric and remote sensing instruments is a fundamental capacity of current mapping systems and a fundamental research topic. Neither digital remote sensing acquisition systems nor direct orientation gear, like INS and GNSS technologies, made block adjustment obsolete. On the contrary, the continuous flow of new primary data acquisition systems has challenged the capacity of the legacy block adjustment systems - in general network adjustment systems - in many aspects: extensibility, genericity, portability, large data sets capacity, metadata support and many others. In this article, we concentrate on the extensibility and genericity challenges that current and future network systems shall face. For this purpose we propose a number of software design strategies with emphasis on rigorous abstract modeling that help in achieving simplicity, genericity and extensibility together with the protection of intellectual proper rights in a flexible manner. We illustrate our suggestions with the general design approach of GENA, the generic extensible network adjustment system of GeoNumerics.

Coal gasification systems engineering and analysis, volume 2

NASA Technical Reports Server (NTRS)

1980-01-01

The major design related features of each generic plant system were characterized in a catalog. Based on the catalog and requirements data, approximately 17 designs and cost estimates were developed for MBG and alternate products. A series of generic trade studies was conducted to support all of the design studies. A set of cost and programmatic analyses were conducted to supplement the designs. The cost methodology employed for the design and sensitivity studies was documented and implemented in a computer program. Plant design and construction schedules were developed for the K-T, Texaco, and B&W MBG plant designs. A generic work breakdown structure was prepared, based on the K-T design, to coincide with TVA's planned management approach. An extensive set of cost sensitivity analyses was completed for K-T, Texaco, and B&W design. Product price competitiveness was evaluated for MBG and the alternate products. A draft management policy and procedures manual was evaluated. A supporting technology development plan was developed to address high technology risk issues. The issues were identified and ranked in terms of importance and tractability, and a plan developed for obtaining data or developing technology required to mitigate the risk.

An Evaluation of Health Service Impacts Consequent to Switching from Brand to Generic Venlafaxine in New Zealand under Conditions of Price Neutrality.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter

2015-07-01

To study the health impact on adult New Zealand patients who switch from originator brand to generic venlafaxine. The national pharmacy database was used to select patients using venlafaxine for at least 6 months. Switchers and nonswitchers were identified, and switch behavior was compared for a 12-month follow-up period. Change in health service use following switching was also compared between switchers and nonswitchers including use of the emergency department, hospital, and specialist outpatient services over the same period. Approximately 12% of all originator brand users switched to generic venlafaxine, at least half of whom continued to use the generic throughout the follow-up period to August 1, 2012. Almost 60% of new users of the generic venlafaxine, however, switched to using the originator brand. Aside from a slight reduction in the use of outpatient services among switchers, there were no significant differences in health services use between switchers and nonswitchers for either existing or new venlafaxine users. Although both products remain fully subsidized and available, there is little incentive for prescribers, pharmacists, or patients to switch to the less expensive generic brand. If savings to the national New Zealand budget are to be realized, additional policy measures should be implemented to minimize incentives for multiple and reverse switching, and prescribers, as key opinion leaders, could take the lead in promoting generics to their patients. Copyright © 2015. Published by Elsevier Inc.

Clinical experience with generic levetiracetam in people with epilepsy

PubMed Central

Chaluvadi, Siresha; Chiang, Sharon; Tran, Larry; Goldsmith, Corey E.; Friedman, David E.

2015-01-01

SUMMARY Purpose To describe the clinical outcomes of a compulsory switch from branded to generic levetiracetam (LEV) among people with epilepsy (PWE) in an outpatient setting. Methods We conducted a retrospective chart review of 760 unduplicated consecutive adult patients attending a tertiary care epilepsy clinic at Ben Taub General Hospital. On November 1, 2008 hospital policy required all patients receiving branded LEV to be automatically switched to generic LEV. We calculated the proportion of patients switching back to branded LEV and reasons for the switch back. Key Findings Of the 260 patients (34%) being prescribed LEV (generic and brand name) during the study period, 105 (42.9%) were switched back to brand name LEV by their treating physicians. Reasons for switch back included increase in seizure frequency (19.6% vs. 1.6%; p < 0.0001) and adverse effects (AEs) (3.3%). AEs included headache, fatigue, and aggression. Patient age was associated with switchback when controlling for gender, epilepsy classification, and treatment characteristics [relative risk (RR) 2.44; 95% confidence interval (CI) 2.09–2.84; p < 0.05)]. An increase in seizure frequency subsequent to generic substitution was associated with polytherapy compared to monotherapy (3.225; 1.512–6.880; p < 0.05). Significance A significant proportion of patients in our cohort on generic LEV required switch back to the branded drug. Careful monitoring is imperative because a compulsory switch from branded to generic LEV may lead to poor clinical outcomes, with risk of AEs and increased seizure frequency. PMID:21426334

Definition and Classification of Generic Drugs Across the World.

PubMed

Alfonso-Cristancho, Rafael; Andia, Tatiana; Barbosa, Tatiana; Watanabe, Jonathan H

2015-08-01

Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30% of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable.

Modeling HIV/AIDS Drug Price Determinants in Brazil: Is Generic Competition a Myth?

PubMed Central

Meiners, Constance; Sagaon-Teyssier, Luis; Hasenclever, Lia; Moatti, Jean-Paul

2011-01-01

Background Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care. Methods and Findings Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition. Significance In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies. PMID:21858138

Modeling HIV/AIDS drug price determinants in Brazil: is generic competition a myth?

PubMed

Meiners, Constance; Sagaon-Teyssier, Luis; Hasenclever, Lia; Moatti, Jean-Paul

2011-01-01

Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care. Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition. In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies.

A generic coding approach for the examination of meal patterns.

PubMed

Woolhead, Clara; Gibney, Michael J; Walsh, Marianne C; Brennan, Lorraine; Gibney, Eileen R

2015-08-01

Meal pattern analysis can be complex because of the large variability in meal consumption. The use of aggregated, generic meal data may address some of these issues. The objective was to develop a meal coding system and use it to explore meal patterns. Dietary data were used from the National Adult Nutrition Survey (2008-2010), which collected 4-d food diary information from 1500 healthy adults. Self-recorded meal types were listed for each food item. Common food group combinations were identified to generate a number of generic meals for each meal type: breakfast, light meals, main meals, snacks, and beverages. Mean nutritional compositions of the generic meals were determined and substituted into the data set to produce a generic meal data set. Statistical comparisons were performed against the original National Adult Nutrition Survey data. Principal component analysis was carried out by using these generic meals to identify meal patterns. A total of 21,948 individual meals were reduced to 63 generic meals. Good agreement was seen for nutritional comparisons (original compared with generic data sets mean ± SD), such as fat (75.7 ± 29.4 and 71.7 ± 12.9 g, respectively, P = 0.243) and protein (83.3 ± 26.9 and 80.1 ± 13.4 g, respectively, P = 0.525). Similarly, Bland-Altman plots demonstrated good agreement (<5% outside limits of agreement) for many nutrients, including protein, saturated fat, and polyunsaturated fat. Twelve meal types were identified from the principal component analysis ranging in meal-type inclusion/exclusion, varying in energy-dense meals, and differing in the constituents of the meals. A novel meal coding system was developed; dietary intake data were recoded by using generic meal consumption data. Analysis revealed that the generic meal coding system may be appropriate when examining nutrient intakes in the population. Furthermore, such a coding system was shown to be suitable for use in determining meal-based dietary patterns. © 2015 American Society for Nutrition.

Traumatic brain injury patient-reported outcome measure: identification of health-related quality-of-life issues relevant to individuals with traumatic brain injury.

PubMed

Carlozzi, Noelle E; Tulsky, David S; Kisala, Pamela A

2011-10-01

This 2-part qualitative study explored health-related quality of life (HRQOL) in individuals with traumatic brain injury (TBI). A community-based participatory action research design was used, which emphasizes collaboration between researchers and individuals with disabilities to ensure that results are relevant for individuals with TBI. In study 1, community members (N=20) with TBI served as "experts" during 1-on-1 semistructured interviews, reviewing current HRQOL items and identifying HRQOL issues commonly experienced by individuals with TBI. Each participant identified at least 31 issues, with most generating more than 90 responses, highlighting the multifaceted nature of HRQOL in TBI. Study 2 consisted of 7 patient/consumer groups (33 individuals with TBI), 4 caregiver groups (17 caregivers), and 2 provider groups (15 providers). Qualitative analysis of patient focus groups indicated that 48% of focus group comments were related to emotional issues; 23%, to social functioning; 14%, to physical functioning; 11%, to cognition; and 7%, to personality changes (caregiver and provider focus group analysis indicated identical patterns of findings). In addition, both studies evaluated the applicability in TBI of generic items developed by the Patient-Reported Outcomes Measurement Information System and the Neurology Quality of Life Measurement initiative. Findings suggest that although there is some overlap between current generic measures of HRQOL and concepts reported by individuals with TBI, these generic measures do not capture the full complexity of HRQOL in TBI. TBI-targeted item banks are needed to ensure sensitive assessment of HRQOL in TBI. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Critical attributes of transdermal drug delivery system (TDDS)--a generic product development review.

PubMed

Ruby, P K; Pathak, Shriram M; Aggarwal, Deepika

2014-11-01

Bioequivalence testing of transdermal drug delivery systems (TDDS) has always been a subject of high concern for generic companies due to the formulation complexity and the fact that they are subtle to even minor manufacturing differences and hence should be clearly qualified in terms of quality, safety and efficacy. In recent times bioequivalence testing of transdermal patches has gained a global attention and many regulatory authorities worldwide have issued recommendations to set specific framework for demonstrating equivalence between two products. These current regulatory procedures demand a complete characterization of the generic formulation in terms of its physicochemical sameness, pharmacokinetics disposition, residual content and/or skin irritation/sensitization testing with respect to the reference formulation. This paper intends to highlight critical in vitro tests in assessing the therapeutic equivalence of products and also outlines their valuable applications in generic product success. Understanding these critical in vitro parameters can probably help to decode the complex bioequivalence outcomes, directing the generic companies to optimize the formulation design in reduced time intervals. It is difficult to summarize a common platform which covers all possible transdermal products; hence few case studies based on this approach has been presented in this review.

Cost comparison and economic implications of commonly used originator and generic chemotherapy drugs in India.

PubMed

Lopes, G de L

2013-09-01

Cancer treatments have improved outcomes but access to medications is an issue around the world and especially so in low- and middle-income countries, such as India. Generic substitution may lead to significant cost savings. The author aimed to compare the cost and estimate potential cost savings per cycle, per patient, and for the country as a whole with generic substitution of frequently used chemotherapy drugs in the treatment of common cancers in India. Generic paclitaxel (Taxol), docetaxel (Taxotere), gemcitabine, oxaliplatin and irinotecan cost from 8.9% to 36% of their equivalent branded originator drug, resulting in cost savings of ~ Indian Rupees (INR) 11,000 to >INR 90,000 (USD 200-1600, Euro 160-1300) per cycle; and ~INR 50,000 to >INR 240,000 (USD 900-4300, Euro 700-3400) per patient. Overall, potential yearly savings for health systems in India were nearly INR 47 billion (~USD 843 million, Euro 670 million). In conclusion, generic substitution for frequently used chemotherapy drugs in the treatment of common cancers has an enormous potential to generate significant cost savings and increase access to cancer treatments in India and other low- and middle-income countries.

Recognizing Severe Adverse Drug Reactions: Two Case Reports After Switching Therapies to the Same Generic Company.

PubMed

Gallelli, Luca; Gallelli, Giuseppe; Codamo, Giuseppe; Argentieri, Angela; Michniewicz, Andzelika; Siniscalchi, Antonio; Stefanelli, Roberta; Cione, Erika; Caroleo, Maria C; Longo, Paola; De Sarro, Giovambattista

2016-01-01

Generic formulations represent a way to reduce the costs of brand compounds when their patent is expired. While, the bio-equivalence in generic drugs is guaranteed, some excipients as well as dyes could be different and this could reduce the drug safety. Herein, we report the development of Adverse Drug Reactions (ADRs) in two patients after the switch from brand to generic formulations. We have tested cytochrome P450 enzymes expression as well as drug serum levels. None of these markers were altered. Checking deeply into both patient's medical history, they harbored poly-sensitivity or allergy to pollen and graminacea and used different active ingredients for different health problems coming from the same generic company Almus(®). This company used different dyes and excipients compared to the branded drugs made by distinguished companies. In conclusion, we strongly suggest to both pharmacists and physicians to be careful in giving the advice to change the drug, thinking to reduce health sanitary costs without considering the personal clinical history of each one. Paradoxically this behavior is causing other health issues, bringing to an increase of the overall costs for patients as well as for National Health System.

Pressurization and expulsion of cryogenic liquids: Generic requirements for a low gravity experiment

NASA Technical Reports Server (NTRS)

Vandresar, Neil T.; Stochl, Robert J.

1991-01-01

Requirements are presented for an experiment designed to obtain data for the pressurization and expulsion of a cryogenic supply tank in a low gravity environment. These requirements are of a generic nature and applicable to any cryogenic fluid of interest, condensible or non-condensible pressurants, and various low gravity test platforms such as the Space Shuttle or a free-flyer. Background information, the thermophysical process, preliminary analytical modeling, and experimental requirements are discussed. Key parameters, measurements, hardware requirements, procedures, a test matrix, and data analysis are outlined.

Security of Distributed-Phase-Reference Quantum Key Distribution

NASA Astrophysics Data System (ADS)

Moroder, Tobias; Curty, Marcos; Lim, Charles Ci Wen; Thinh, Le Phuc; Zbinden, Hugo; Gisin, Nicolas

2012-12-01

Distributed-phase-reference quantum key distribution stands out for its easy implementation with present day technology. For many years, a full security proof of these schemes in a realistic setting has been elusive. We solve this long-standing problem and present a generic method to prove the security of such protocols against general attacks. To illustrate our result, we provide lower bounds on the key generation rate of a variant of the coherent-one-way quantum key distribution protocol. In contrast to standard predictions, it appears to scale quadratically with the system transmittance.

News media coverage of medication research: reporting pharmaceutical company funding and use of generic medication names.

PubMed

Hochman, Michael; Hochman, Steven; Bor, David; McCormick, Danny

2008-10-01

The news media are an important source of information about medical research for patients and even some physicians. Little is known about how frequently news articles report when medication research has received funding from pharmaceutical companies or how frequently news articles use generic vs brand medication names. To assess the reporting of pharmaceutical company funding and generic medication name use in news articles about medication studies and to determine the views of newspaper editors about these issues. We reviewed US news articles from newspaper and online sources about all pharmaceutical company-funded medication studies published in the 5 most prominent general medical journals between April 1, 2004, and April 30, 2008. We also surveyed editors at the 100 most widely circulated newspapers in the United States. The percentage of news articles indicating when studies have been pharmaceutical company-funded and the percentage that refer to medications by their generic vs brand names. Also the percentage of newspaper editors who indicate that their articles report pharmaceutical company funding; the percentage of editors who indicate that their articles refer to medications by generic names; and the percentage of newspapers with policies about these issues. Of the 306 news articles about medication research identified,130 (42%; 95% confidence interval [CI], 37%-48%) did not report that the research had received company funding. Of the 277 of these articles reporting on medications with both generic and brand names, 186 (67%; 95% CI, 61%-73%) referred to the study medications by their brand names in at least half of the medication references. Eighty-two of the 93 (88%) newspaper editors who responded to our survey reported that articles from their publications always or often indicated when studies had received company funding (95% CI, 80%-94%), and 71 of 92 (77%) responding editors also reported that articles from their publications always or often referred to medications by the generic names (95% CI, 67%-85%). However, only 3 of 92 newspapers (3%) had written policies stating that company funding sources of medical studies be reported (95% CI 1%-9%), and 2 of 93 (2%) newspapers had written policies stating that medications should be referred to by their generic names (95% CI 1%-8%). News articles reporting on medication studies often fail to report pharmaceutical company funding and frequently refer to medications by their brand names despite newspaper editors' contention that this is not the case.

The limits of acceptable change process: modifications and clarifications

Treesearch

David N. Cole; Stephen F. McCool

1997-01-01

Limits of Acceptable Change (LAC) was originally formulated to deal with the issue of recreation carrying capacity in wilderness. Enthusiasm for the process has led to questions about its applicability to a broad range of natural resource issues—both within and outside of protected areas. This paper uses a generic version of the LAC process to identify situations where...

10 CFR 171.16 - Annual fees: Materials licensees, holders of certificates of compliance, holders of sealed source...

Code of Federal Regulations, 2012 CFR

2012-01-01

... fee is the sum of budgeted costs for the following activities: (1) Generic and other research... material issued under parts 30 and 33 of this chapter for research and development that do not authorize... licenses for possession and use of byproduct material issued under part 30 of this chapter for research and...

A new generic system for the pantropical Caesalpinia group (Leguminosae).

PubMed

Gagnon, Edeline; Bruneau, Anne; Hughes, Colin E; de Queiroz, Luciano Paganucci; Lewis, Gwilym P

2016-01-01

The Caesalpinia group is a large pantropical clade of ca. 205 species in subfamily Caesalpinioideae (Leguminosae) in which generic delimitation has been in a state of considerable flux. Here we present new phylogenetic analyses based on five plastid and one nuclear ribosomal marker, with dense taxon sampling including 172 (84%) of the species and representatives of all previously described genera in the Caesalpinia group. These analyses show that the current classification of the Caesalpinia group into 21 genera needs to be revised. Several genera ( Poincianella , Erythrostemon , Cenostigma and Caesalpinia sensu Lewis, 2005) are non-monophyletic and several previously unclassified Asian species segregate into clades that merit recognition at generic rank. In addition, the near-completeness of our taxon sampling identifies three species that do not belong in any of the main clades and these are recognised as new monospecific genera. A new generic classification of the Caesalpinia group is presented including a key for the identification of genera, full generic descriptions, illustrations (drawings and photo plates of all genera), and (for most genera) the nomenclatural transfer of species to their correct genus. We recognise 26 genera, with reinstatement of two previously described genera ( Biancaea Tod., Denisophytum R. Vig.), re-delimitation and expansion of several others ( Moullava , Cenostigma , Libidibia and Erythrostemon ), contraction of Caesalpinia s.s. and description of four new ones ( Gelrebia , Paubrasilia , Hererolandia and Hultholia ), and make 75 new nomenclatural combinations in this new generic system.

Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases.

PubMed

Park-Wyllie, Laura; van Stralen, Judy; Castillon, Genaro; Sherman, Stephen E; Almagor, Doron

2017-10-01

Our study evaluated adverse events of therapeutic failure (and specifically reduced duration of action) with the use of a branded product, Osmotic Release Oral System (OROS) methylphenidate, which is approved for the treatment of attention deficit/hyperactivity disorder, and a generic product (methylphenidate, methylphenidate ER-C), which was approved for marketing in Canada based on bioequivalence to OROS methylphenidate. This study was initiated following reports that some US-marketed generic methylphenidate ER products had substantially higher reporting rates of therapeutic failure than did the referenced brands. Through methodology similar to that used by the US Food and Drug Administration to investigate the issue with the US-marketed generic, reporting rates were calculated from cases of therapeutic failure identified in the Canadian Vigilance Adverse Reaction Online database for a 1-year period beginning 8 months after each product launch. Corresponding population exposure was estimated from the number of tablets dispensed. An in-depth analysis of narratives of individual case safety reports (ICSRs) with the use of the generic product was conducted in duplicate by 2 physicians to assess causality and to characterize the potential safety risk and clinical pattern of therapeutic failure. Similar secondary analyses were conducted on the US-marketed products. Reporting rates of therapeutic failure with the use of methylphenidate ER-C (generic) and OROS methylphenidate (brand name) were 411.5 and 37.5 cases per 100,000 patient-years, respectively (reporting rate ratio, 10.99; 95% CI, 5.93-22.21). In-depth analysis of narratives of 230 ICSRs of therapeutic failure with the Canadian-marketed generic determined that all ICSRs were either probably (60 [26%]) or possibly (170 [74%]) causally related to methylphenidate ER-C. Clinical symptoms suggestive of overdose were present in 31 reports of loss of efficacy (13.5%) and occurred primarily in the morning, and premature loss of efficacy (shorter duration of action) was described in 98 cases (42.6%) and occurred primarily in the afternoon. Impacts on social functioning, such as disruption in work or school performance or adverse social behaviors, were found in 51 cases (22.2%). The ~10-fold higher reporting rate of therapeutic failure with the generic product relative to its reference product in the present Canadian study resembles findings with US-marketed generic products. While these results should be interpreted with caution due to the limitations of spontaneous adverse event reporting, which may confound comparisons across products, similar findings nonetheless led the US Food and Drug Administration to declare in 2014 that 2 methylphenidate ER generic products in the United States were neither bioequivalent nor interchangeable with OROS methylphenidate-their reference product. Our results indicate a potential safety issue with the Canadian-marketed generic and suggest a need for further investigation by Health Canada. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Human Reliability and Ship Stability

DTIC Science & Technology

2003-07-04

models such as Miller (1957) and Broadbent (1959) is the idea of human beings as limited capacity information processors with constraints on...15 4.2.2 Outline of Some Key models ...23 TABLE 11: GENERIC ERROR MODELING SYSTEM

Experiments in Neural-Network Control of a Free-Flying Space Robot

NASA Technical Reports Server (NTRS)

Wilson, Edward

1995-01-01

Four important generic issues are identified and addressed in some depth in this thesis as part of the development of an adaptive neural network based control system for an experimental free flying space robot prototype. The first issue concerns the importance of true system level design of the control system. A new hybrid strategy is developed here, in depth, for the beneficial integration of neural networks into the total control system. A second important issue in neural network control concerns incorporating a priori knowledge into the neural network. In many applications, it is possible to get a reasonably accurate controller using conventional means. If this prior information is used purposefully to provide a starting point for the optimizing capabilities of the neural network, it can provide much faster initial learning. In a step towards addressing this issue, a new generic Fully Connected Architecture (FCA) is developed for use with backpropagation. A third issue is that neural networks are commonly trained using a gradient based optimization method such as backpropagation; but many real world systems have Discrete Valued Functions (DVFs) that do not permit gradient based optimization. One example is the on-off thrusters that are common on spacecraft. A new technique is developed here that now extends backpropagation learning for use with DVFs. The fourth issue is that the speed of adaptation is often a limiting factor in the implementation of a neural network control system. This issue has been strongly resolved in the research by drawing on the above new contributions.

Knowledge and perceptions of physicians from private medical centres towards generic medicines: a nationwide survey from Malaysia.

PubMed

Kumar, Rohit; Hassali, Mohamed Azmi; Saleem, Fahad; Alrasheedy, Alian A; Kaur, Navneet; Wong, Zhi Yen; Kader, Muhamad Ali Sk Abdul

2015-01-01

Generic medicine prescribing has become a common practice in public hospitals. However, the trend in private medical centres seems to be different. The objective of this study was to investigate knowledge, perceptions and behavior of physicians from private medical centres in Malaysia regarding generic medicines. This study was a cross-sectional nationwide survey targeting physicians from private medical centres in Malaysia. The survey was conducted using questionnaire having (i) background and demographic data of the physicians, volume of prescription in a day, stock of generic medicines in their hospital pharmacy etc. (ii) their knowledge about bioequivalence (iii) prescribing behavior (iv) physicians' knowledge of quality, safety and efficacy of generic medicines, and their cost (v) perceptions of physicians towards issues pertaining to generic medicines utilization. A total of 263 questionnaires out of 735 were received, giving a response rate of 35.8%. Of the respondents, 214 (81.4%) were male and 49 (18.6%) were females. The majority of the participants were in the age range of 41-50 years and comprised 49.0% of the respondents. Only 2.3% of physicians were aware of the regulatory limits of bioequivalence standards in Malaysia. Of the respondents, 23.2% agreed that they 'always' write their prescriptions using originator product name whereas 50.2% do it 'usually'. A number of significant associations were found between their knowledge, perceptions about generic medicines and their demographic characteristics. The majority of the physicians from private medical centres in Malaysia had negative perceptions about safety, quality and the efficacy of generic medicines. These negative perceptions could be the cause of the limited use of generic medicines in the private medical centres. Therefore, in order to facilitate their use, it is recommended that the physicians need to be reassured and educated about the drug regulatory authority approval system of generic medicines with regard to their bioequivalence, quality, efficacy and safety. Apart from the policy on generic substitution, it would also be recommended to have a national medicine pricing policy, which controls drug prices, in both the public and private sector. These efforts are worthwhile to reduce the drug expenditure and improve the medicine affordability in Malaysia.

Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease

PubMed Central

Kesselheim, Aaron S.; Misono, Alexander S.; Lee, Joy L.; Stedman, Margaret R.; Brookhart, M. Alan; Choudhry, Niteesh K.; Shrank, William H.

2009-01-01

Context Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs. Objectives To summarize clinical evidence comparing generic and brand-name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue. Data Sources Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008. Study Selection Studies compared generic and brand-name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution. Data Extraction We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors’ positions on generic substitution as negative, positive, or neutral. Results We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of β-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of α-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was −0.03 (95% confidence interval, −0.15 to 0.08), indicating no evidence of superiority of brand-name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution. Conclusions Whereas evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs. PMID:19050195

[A functional analysis of healthcare auditors' skills in Venezuela, 2008].

PubMed

Chirinos-Muñoz, Mónica S

2010-10-01

Using functional analysis for identifying the basic, working, specific and generic skills and values which a health service auditor must have. Implementing the functional analysis technique with 10 experts, identifying specific, basic, generic skills and values by means of deductive logic. A functional map was obtained which started by establishing a key purpose based on improving healthcare and service quality from which three key functions emerged. The main functions and skills' units were then broken down into the competitive elements defining what a health service auditor is able to do. This functional map (following functional analysis methodology) shows in detail the simple and complex tasks which a healthcare auditor should apply in the workplace, adopting a forward management approach for improving healthcare and health service quality. This methodology, expressing logical-deductive awareness raising, provides expert consensual information validating each element regarding overall skills.

Spontaneous Gender Categorization in Masking and Priming Studies: Key for Distinguishing Jane from John Doe but Not Madonna from Sinatra

PubMed Central

Habibi, Ruth; Khurana, Beena

2012-01-01

Facial recognition is key to social interaction, however with unfamiliar faces only generic information, in the form of facial stereotypes such as gender and age is available. Therefore is generic information more prominent in unfamiliar versus familiar face processing? In order to address the question we tapped into two relatively disparate stages of face processing. At the early stages of encoding, we employed perceptual masking to reveal that only perception of unfamiliar face targets is affected by the gender of the facial masks. At the semantic end; using a priming paradigm, we found that while to-be-ignored unfamiliar faces prime lexical decisions to gender congruent stereotypic words, familiar faces do not. Our findings indicate that gender is a more salient dimension in unfamiliar relative to familiar face processing, both in early perceptual stages as well as later semantic stages of person construal. PMID:22389697

The nine-year sustained cost-containment impact of swiss pilot physicians-pharmacists quality circles.

PubMed

Niquille, Anne; Ruggli, Martine; Buchmann, Michel; Jordan, Dominique; Bugnon, Olivier

2010-04-01

Six pioneer physicians-pharmacists quality circles (PPQCs) located in the Swiss canton of Fribourg (administratively corresponding to a state in the US) were under the responsibility of 6 trained community pharmacists moderating the prescribing process of 24 general practitioners (GPs). PPQCs are based on a multifaceted collaborative process mediated by community pharmacists for improving compliance with clinical guidelines within GPs' prescribing practices. To assess, over a 9-year period (1999-2007), the cost-containment impact of the PPQCs. The key elements of PPQCs are a structured continuous quality improvement and education process; local networking; feedback of comparative and detailed data regarding costs, drug choice, and frequency of prescribed drugs; and structured independent literature review for interdisciplinary continuing education. The data are issued from the community pharmacy invoices to the health insurance companies. The study analyzed the cost-containment impact of the PPQCs in comparison with GPs working in similar conditions of care without particular collaboration with pharmacists, the percentage of generic prescriptions for specific cardiovascular drug classes, and the percentage of drug costs or units prescribed for specific cardiovascular drugs. For the 9-year period, there was a 42% decrease in the drug costs in the PPQC group as compared to the control group, representing a $225,000 (USD) savings per GP only in 2007. These results are explained by better compliance with clinical and pharmacovigilance guidelines, larger distribution of generic drugs, a more balanced attitude toward marketing strategies, and interdisciplinary continuing education on the rational use of drugs. The PPQC work process has yielded sustainable results, such as significant cost savings, higher penetration of generics and reflection on patient safety, and the place of "new" drugs in therapy. The PPQCs may also constitute a solid basis for implementing more comprehensive collaborative programs, such as medication reviews, adherence-enhancing interventions, or disease management approaches.

Patent cliff mitigation strategies: giving new life to blockbusters.

PubMed

Kakkar, Ashish Kumar

2015-01-01

With several blockbuster drugs on the brink of another significant patent expiry cliff, innovator pharmaceutical firms are at risk of losing billions of dollars in sales to generic competition. With issues such as staggering R&D costs, reduced productivity and increasing governmental emphasis on pharmacoeconomics, timely planning and implementation of product lifecycle management strategies is becoming indispensable. A variety of strategies designed to mitigate the post-patent expiry revenue loss exist. These approaches range from fairly straightforward measures, such as strategic price cuts and launching own or authorized generics, to complex and lengthy ones, such as new formulations and indications that require companies to reinvent their pharmaceuticals. As patent expiries loom and product pipelines continue to remain thin, proactive planning for generic entry will be critical for pharma companies to drive growth and earnings in a sustainable manner.

THE PRACTICE OF STRUCTURE ACTIVITY RELATIONSHIPS (SAR) IN TOXICOLOGY

EPA Science Inventory

Both qualitative and quantitative modeling methods relating chemical structure to biological activity, called structure-activity relationship analyses or SAR, are applied to the prediction and characterization of chemical toxicity. This minireview will discuss some generic issue...

Access to generic drugs in the 1950s: the politics of a social problem.

PubMed Central

Facchinetti, N J; Dickson, W M

1982-01-01

From the published literature of the 1950s, the social history of anti-substitution law is analyzed in terms of sociological theory on the construction of social problems. The analysis reveals how the substitution of generic drugs for prescribed brands came to be recognized as a social problem in need of remedial legislation. The most influential party in the process was the brand-drug industry which centered the debate on matters of public health and professionalism instead of industrial profitability. The industry was able to form a coalition of interests and establish the saliency and legitimacy of the problem, even though there was no objective evidence to establish brand substitution as a hazard to health. The case fits well into the theory of social problem construction. Other issues in health care, particularly drug issues can be studied from this same perspective. PMID:7065335

Predicting of biomass in Brazilian tropical dry forest: a statistical evaluation of generic equations.

PubMed

Lima, Robson B DE; Alves, Francisco T; Oliveira, Cinthia P DE; Silva, José A A DA; Ferreira, Rinaldo L C

2017-01-01

Dry tropical forests are a key component in the global carbon cycle and their biomass estimates depend almost exclusively of fitted equations for multi-species or individual species data. Therefore, a systematic evaluation of statistical models through validation of estimates of aboveground biomass stocks is justifiable. In this study was analyzed the capacity of generic and specific equations obtained from different locations in Mexico and Brazil, to estimate aboveground biomass at multi-species levels and for four different species. Generic equations developed in Mexico and Brazil performed better in estimating tree biomass for multi-species data. For Poincianella bracteosa and Mimosa ophthalmocentra, only the Sampaio and Silva (2005) generic equation was the most recommended. These equations indicate lower tendency and lower bias, and biomass estimates for these equations are similar. For the species Mimosa tenuiflora, Aspidosperma pyrifolium and for the genus Croton the specific regional equations are more recommended, although the generic equation of Sampaio and Silva (2005) is not discarded for biomass estimates. Models considering gender, families, successional groups, climatic variables and wood specific gravity should be adjusted, tested and the resulting equations should be validated at both local and regional levels as well as on the scales of tropics with dry forest dominance.

Implementing the space shuttle data processing system with the space generic open avionics architecture

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1993-01-01

This paper presents an overview of the application of the Space Generic Open Avionics Architecture (SGOAA) to the Space Shuttle Data Processing System (DPS) architecture design. This application has been performed to validate the SGOAA, and its potential use in flight critical systems. The paper summarizes key elements of the Space Shuttle avionics architecture, data processing system requirements and software architecture as currently implemented. It then summarizes the SGOAA architecture and describes a tailoring of the SGOAA to the Space Shuttle. The SGOAA consists of a generic system architecture for the entities in spacecraft avionics, a generic processing external and internal hardware architecture, a six class model of interfaces and functional subsystem architectures for data services and operations control capabilities. It has been proposed as an avionics architecture standard with the National Aeronautics and Space Administration (NASA), through its Strategic Avionics Technology Working Group, and is being considered by the Society of Aeronautic Engineers (SAE) as an SAE Avionics Standard. This architecture was developed for the Flight Data Systems Division of JSC by the Lockheed Engineering and Sciences Company, Houston, Texas.

Design for Assured Safe Jettison Operations

NASA Astrophysics Data System (ADS)

Herd, Andrew; Shea, Matt

2010-09-01

The International Space Station is coming toward the end of the assembly process and will enter "steady state" operations. During this time and also in the future, there arises the need for removing items from station, and in some instances this is achieved through jettison, either robotic or crew initiated. To control this practice at the ISS Partner level, a policy document has been developed. The policy states: "While there are risks inherent in jettisoning objects, the ISS Program recognizes that there may be significant benefits in terms of operational flexibility, crew safety, etc. A thorough assessment of the risks vs. the benefits will be conducted whenever a proposal to jettison an object is made. It is the intent of the ISS Program to limit the number of objects that are jettisoned from the ISS ...". The policy addresses hardware that: "may fall into one or more of the following categories: 1. Items that pose a safety issue for the ISS or for return onboard a visiting vehicle(contamination, materials degradation, etc.) 2. Items that negatively impact ISS utilization, return or on-orbit stowage manifests 3. Items that represent an Extravehicular Activity(EVA) timeline savings large enough to reduce the sum of the risks of EVA exposure time and the orbital environment’s hazardous debris population, compared to the sum of such risks without a jettison. 4. Items that are designed for jettison ". [1] Through the use of jettison to date, as a disposal means, operational experiences have been gained during and as a result of post-disposal event analysis. The data collected has allowed a generic assessment of issues(and best practices) and the proposal of ways in which process corrective action can be taken to assure future safe jettison operations. The improvements proposed emphasize the ways in which design can offer key interface and hardware response characteristics to the jettison event and the subsequent orbital and re-entry profile. There exist simple and effective ways to address key issues(a number but not all are covered by specific requirements) and credible rationale for the case that any limited life spaceflight hardware integrated into the extravehicular environment shall be capable of being safely jettisoned(for reasons 1, 2 & 3). While most hardware was not initially intended to be disposed of in this manner, the approval process for reason 4 can accommodate necessary, and in some cases inevitable, programmatic decisions to jettison. This should be achieved either through the hardware itself being compatible with the jettison best-practice design guidelines, or the design offering an interface compatible with a generic jettison platform that inherently minimizes risk.

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

PubMed

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

2017-01-01

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

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

PubMed Central

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

2017-01-01

In today’s competitive world, there are several strategies to deal with the fast changing environment, among which New product development (NPD) is a common strategy. However, almost half of the resources that companies devote to NPD are spent on products that may fail. This issue is particularly highlighted in the pharmaceutical industry mainly because of a long development-time, low success rate, high capital requirement, and market uncertainty. This study identifies critical success factors of NPD based on the relevant literatures and expert opinions in Iranian pharmaceutical industry, then prioritizes them using the methodology of multiple criteria decision making (MCDM) through analyzing 50 filled questionnaires structured based on the AHP (Analytical Hierarchy Process) approach. Although the NPD success factors seem the same in both generic and bio-generic pharmaceutical industries, the underlying factors and related sub-factors show the different importance in these two industries. However, this study reveal that, the company capabilities is the most important factor affecting new product development success in both pharmaceutical generic and bio-generic industry. The results of this study contribute to create baseline information for pharmaceutical industry especially Iranian pharmaceutical companies to be more effective in budget allocation on improving NPD success factors so that they can boost the success rate of NPD more effectively. PMID:28979339

Generic synopsis of the jumping plant-lice (Hemiptera: Sternorrhyncha: Psylloidea) from Colombia.

PubMed

Rendón-Mera, Diana Isabel; Serna, Francisco; Burckhardt, Daniel

2017-11-20

Jumping plant-lice (Hemiptera: Sternorrhyncha: Psylloidea) are a group of phloem-feeding insects with nearly 4000        described species. Previous records from Colombia comprise 19 genera of all eight known families. The revision of material deposited in six Colombian and three foreign museums yielded another nine genera that constitute new country records. Material from 16 departments was examined. Each genus is diagnosed and information is provided on biology, damage and host-plants. Local distribution maps and a generic key for the identification of adults are provided.

A new generic system for the pantropical Caesalpinia group (Leguminosae)

PubMed Central

Gagnon, Edeline; Bruneau, Anne; Hughes, Colin E.; de Queiroz, Luciano Paganucci; Lewis, Gwilym P.

2016-01-01

Abstract The Caesalpinia group is a large pantropical clade of ca. 205 species in subfamily Caesalpinioideae (Leguminosae) in which generic delimitation has been in a state of considerable flux. Here we present new phylogenetic analyses based on five plastid and one nuclear ribosomal marker, with dense taxon sampling including 172 (84%) of the species and representatives of all previously described genera in the Caesalpinia group. These analyses show that the current classification of the Caesalpinia group into 21 genera needs to be revised. Several genera (Poincianella, Erythrostemon, Cenostigma and Caesalpinia sensu Lewis, 2005) are non-monophyletic and several previously unclassified Asian species segregate into clades that merit recognition at generic rank. In addition, the near-completeness of our taxon sampling identifies three species that do not belong in any of the main clades and these are recognised as new monospecific genera. A new generic classification of the Caesalpinia group is presented including a key for the identification of genera, full generic descriptions, illustrations (drawings and photo plates of all genera), and (for most genera) the nomenclatural transfer of species to their correct genus. We recognise 26 genera, with reinstatement of two previously described genera (Biancaea Tod., Denisophytum R. Vig.), re-delimitation and expansion of several others (Moullava, Cenostigma, Libidibia and Erythrostemon), contraction of Caesalpinia s.s. and description of four new ones (Gelrebia, Paubrasilia, Hererolandia and Hultholia), and make 75 new nomenclatural combinations in this new generic system. PMID:28814915

Government Contractors and Sticky SGA Costs

DTIC Science & Technology

2015-04-30

supply generic products such as toothpaste which do not require satisfying unique federal requirements (and related paperwork). For these reasons... toothpaste . Proctor and Gamble may not need to deal with issues involving government-specific specifications and may have minimal incremental paperwork

A Security Framework for Online Distance Learning and Training.

ERIC Educational Resources Information Center

Furnell, S. M.; Onions, P. D.; Bleimann, U.; Gojny, U.; Knahl, M.; Roder, H. F.; Sanders, P. W.

1998-01-01

Presents a generic reference model for online distance learning and discusses security issues for each stage (enrollment, study, completion, termination, suspension). Discusses a security framework (authentication and accountability, access control, intrusion detection, network communications, nonrepudiation, learning resources provider…

The Role of Condition-Specific Preference-Based Measures in Health Technology Assessment.

PubMed

Rowen, Donna; Brazier, John; Ara, Roberta; Azzabi Zouraq, Ismail

2017-12-01

A condition-specific preference-based measure (CSPBM) is a measure of health-related quality of life (HRQOL) that is specific to a certain condition or disease and that can be used to obtain the quality adjustment weight of the quality-adjusted life-year (QALY) for use in economic models. This article provides an overview of the role and the development of CSPBMs, and presents a description of existing CSPBMs in the literature. The article also provides an overview of the psychometric properties of CSPBMs in comparison with generic preference-based measures (generic PBMs), and considers the advantages and disadvantages of CSPBMs in comparison with generic PBMs. CSPBMs typically include dimensions that are important for that condition but may not be important across all patient groups. There are a large number of CSPBMs across a wide range of conditions, and these vary from covering a wide range of dimensions to more symptomatic or uni-dimensional measures. Psychometric evidence is limited but suggests that CSPBMs offer an advantage in more accurate measurement of milder health states. The mean change and standard deviation can differ for CSPBMs and generic PBMs, and this may impact on incremental cost-effectiveness ratios. CSPBMs have a useful role in HTA where a generic PBM is not appropriate, sensitive or responsive. However, due to issues of comparability across different patient groups and interventions, their usage in health technology assessment is often limited to conditions where it is inappropriate to use a generic PBM or sensitivity analyses.

Differentiating low-molecular-weight heparins based on chemical, biological, and pharmacologic properties: implications for the development of generic versions of low-molecular-weight heparins.

PubMed

Jeske, Walter P; Walenga, Jeanine M; Hoppensteadt, Debra A; Vandenberg, Curtis; Brubaker, Aleah; Adiguzel, Cafer; Bakhos, Mamdouh; Fareed, Jawed

2008-02-01

Low-molecular-weight heparins (LMWHs) are polypharmacologic drugs used to treat thrombotic and cardiovascular disorders. These drugs are manufactured using different chemical and enzymatic methods, resulting in products with distinct chemical and pharmacologic profiles. Generic LMWHs have been introduced in Asia and South America, and several generic suppliers are seeking regulatory approval in the United States and the European Union. For simple small-molecule drugs, generic drugs have the same chemical structure, potency, and bioavailability as the innovator drug. Applying this definition to complex biological products such as the LMWHs has proved difficult. One major issue is defining appropriate criteria to demonstrate bioequivalence; pharmacopoeial specifications alone appear to be inadequate. Whereas available generic versions of LMWHs exhibit similar molecular and pharmacopoeial profiles, marked differences in their biological and pharmacologic behavior have been noted. Preliminary studies have demonstrated differences in terms of anti-Xa activity and tissue factor pathway inhibitor release after subcutaneous administration, as well as antiplatelet and profibrinolytic effects. The current data emphasize the need to consider multiple functional parameters when defining bioequivalence of biologic drugs with complex structures and activities and also underscore the importance of further pharmacologic studies involving animal models and human clinical trials. The U.S. Food and Drug Administration and the European Medicine Evaluation Agency are currently developing guidelines for the acceptance of biosimilar agents including LMWHs. Until such guidelines are complete, generic interchange may not be feasible.

Generic Stellarator-like Magnetic Fusion Reactor

NASA Astrophysics Data System (ADS)

Sheffield, John; Spong, Donald

2015-11-01

The Generic Magnetic Fusion Reactor paper, published in 1985, has been updated, reflecting the improved science and technology base in the magnetic fusion program. Key changes beyond inflation are driven by important benchmark numbers for technologies and costs from ITER construction, and the use of a more conservative neutron wall flux and fluence in modern fusion reactor designs. In this paper the generic approach is applied to a catalyzed D-D stellarator-like reactor. It is shown that an interesting power plant might be possible if the following parameters could be achieved for a reference reactor: R/ < a > ~ 4 , confinement factor, fren = 0.9-1.15, < β > ~ 8 . 0 -11.5 %, Zeff ~ 1.45 plus a relativistic temperature correction, fraction of fast ions lost ~ 0.07, Bm ~ 14-16 T, and R ~ 18-24 m. J. Sheffield was supported under ORNL subcontract 4000088999 with the University of Tennessee.

Generic Raman-based calibration models enabling real-time monitoring of cell culture bioreactors.

PubMed

Mehdizadeh, Hamidreza; Lauri, David; Karry, Krizia M; Moshgbar, Mojgan; Procopio-Melino, Renee; Drapeau, Denis

2015-01-01

Raman-based multivariate calibration models have been developed for real-time in situ monitoring of multiple process parameters within cell culture bioreactors. Developed models are generic, in the sense that they are applicable to various products, media, and cell lines based on Chinese Hamster Ovarian (CHO) host cells, and are scalable to large pilot and manufacturing scales. Several batches using different CHO-based cell lines and corresponding proprietary media and process conditions have been used to generate calibration datasets, and models have been validated using independent datasets from separate batch runs. All models have been validated to be generic and capable of predicting process parameters with acceptable accuracy. The developed models allow monitoring multiple key bioprocess metabolic variables, and hence can be utilized as an important enabling tool for Quality by Design approaches which are strongly supported by the U.S. Food and Drug Administration. © 2015 American Institute of Chemical Engineers.

Generic continuity of operations/continuity of government plan for state-level transportation agencies.

DOT National Transportation Integrated Search

2011-08-01

The Homeland Security Presidential Directive 20 (HSPD-20) requires all local, state, tribal and territorial government agencies, and private sector owners of critical infrastructure and key resources (CI/KR) to create a Continuity of Operationsl:onti...

Relating GTE and Knowledge-Based Courseware Engineering: Some Epistemological Issues.

ERIC Educational Resources Information Center

De Diana, Italo P. F.; Ladhani, Al-Noor

1998-01-01

Discusses GTE (Generic Tutoring Environment) and knowledge-based courseware engineering from an epistemological point of view and suggests some combination of the two approaches. Topics include intelligent tutoring; courseware authoring; application versus acquisition of knowledge; and domain knowledge. (LRW)

Patent protection strategies

PubMed Central

Gupta, Himanshu; Kumar, Suresh; Roy, Saroj Kumar; Gaud, R. S.

2010-01-01

It is widely recognized that the pharmaceutical industry faces serious financial challenges. Large numbers of blockbuster drugs are losing patent protection and going generic. The pipeline of new drugs is too sparse to fill the gap and generate a platform for future growth. Moreover, many of the new products are biologics with much narrower target patient populations and comparatively higher prices relative to traditional pharmaceuticals. So now the time has come for pharmaceutical scientists to have a better understanding of patent fundamentals. This need is illustrated by analyses of key scientific and legal issues that arose during recent patent infringement cases involving Prozac, Prilosec, and Buspar. Facing this scenario, the pharmaceutical industry has moved to accelerate drug development process and to adopt at the same time different strategies to extend the life time of the patent monopoly to provide the economic incentives and utilizing it for drug discovery and development. This review covers the need of patent protection and various strategies to extend the patent. PMID:21814422

Australian defence requirements and initiatives in smart materials and structures

NASA Astrophysics Data System (ADS)

Wilson, Alan R.; Galea, Stephen C.; Scala, Christine; Wong, Albert

2002-11-01

The Australian Defence Force is increasingly facing escalating costs on through-life support for major platforms (ships, aircraft and land vehicles). The application of smart materials and structures technologies in platform management systems is seen as a very promising approach to reduce these costs and to potentially achieve significant enhancement of platform capability. A new DSTO Key Initiative, 'Smart Materials and Structures', has been recently developed and funded to address these technologies. The Initiative will build on and grow the current activities within DSTO and promote collaboration with external Australian institutes and industry. This paper will present an overview of the Initiative and the generic sensor and system issues inherent in the 'whole-of-platform' and 'whole-of-life' monitoring and management of major defence platforms. Examples for some particular elements of this will be drawn from current work in DSTO. Other presentations in the conference will cover the technical and scientific aspects of these in more detail.

Perceptions of the quality of generic medicines: implications for trust in public services within the local health system in Tumkur, India.

PubMed

Aivalli, Praveen Kumar; Elias, Maya Annie; Pati, Manoj Kumar; Bhanuprakash, Srinath; Munegowda, Chikkagollahalli; Shroff, Zubin Cyrus; Srinivas, Prashanth N

2017-01-01

Generic medicines are an important policy option to reduce out-of-pocket expenditure on medicines. However, negative perceptions of their quality affect utilisation and raise issues of confidence and trust in medicines and health services. The aim of the study was to test the quality of generic and branded medicines and explain negative perceptions towards generic medicines. The study was part of a larger study on access to medicines. Information on various quality parameters was collected for branded medicines and branded and unbranded generic versions of the same medicines from government and private pharmacies in Karnataka in Southern India. To assess perceptions related to quality and drivers of preferred point of care (public vs private), focus group discussions were conducted with diabetes and hypertension patients, health workers and private pharmacists. The results of the quality tests were assessed and thematic analysis was conducted on the qualitative data to develop a conceptual framework to explain perceptions of medicine and care quality in the local health system. The generic and branded variants of the medicines tested were of comparable quality. Contrary to the quality test results, patients' and health workers' perceptions of quality were largely in favour of branded medicines. Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector. Trust in the health system emerged as an underlying central theme that explained and drove choice of medicines and providers within the local health system. Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behaviour and affect trust in healthcare provided in public services. To succeed, access to medicines programmes need to systematically invest in information on quality of medicines and develop strategies to build trust in healthcare offered in government health services.

Perceptions of the quality of generic medicines: implications for trust in public services within the local health system in Tumkur, India

PubMed Central

Aivalli, Praveen Kumar; Elias, Maya Annie; Pati, Manoj Kumar; Bhanuprakash, Srinath; Munegowda, Chikkagollahalli; Shroff, Zubin Cyrus

2017-01-01

Introduction Generic medicines are an important policy option to reduce out-of-pocket expenditure on medicines. However, negative perceptions of their quality affect utilisation and raise issues of confidence and trust in medicines and health services. The aim of the study was to test the quality of generic and branded medicines and explain negative perceptions towards generic medicines. Methods The study was part of a larger study on access to medicines. Information on various quality parameters was collected for branded medicines and branded and unbranded generic versions of the same medicines from government and private pharmacies in Karnataka in Southern India. To assess perceptions related to quality and drivers of preferred point of care (public vs private), focus group discussions were conducted with diabetes and hypertension patients, health workers and private pharmacists. The results of the quality tests were assessed and thematic analysis was conducted on the qualitative data to develop a conceptual framework to explain perceptions of medicine and care quality in the local health system. Results The generic and branded variants of the medicines tested were of comparable quality. Contrary to the quality test results, patients’ and health workers’ perceptions of quality were largely in favour of branded medicines. Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector. Trust in the health system emerged as an underlying central theme that explained and drove choice of medicines and providers within the local health system. Conclusion Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behaviour and affect trust in healthcare provided in public services. To succeed, access to medicines programmes need to systematically invest in information on quality of medicines and develop strategies to build trust in healthcare offered in government health services. PMID:29531844

Planetary mapping—The datamodel's perspective and GIS framework

NASA Astrophysics Data System (ADS)

van Gasselt, S.; Nass, A.

2011-09-01

Demands for a broad range of integrated geospatial data-analysis tools and methods for planetary data organization have been growing considerably since the late 1990s when a plethora of missions equipped with new instruments entered planetary orbits or landed on the surface. They sent back terabytes of new data which soon became accessible for the scientific community and public and which needed to be organized. On the terrestrial side, issues of data access, organization and utilization for scientific and economic analyses are handled by using a range of well-established geographic information systems (GIS) that also found their way into the field of planetary sciences in the late 1990s. We here address key issues concerning the field of planetary mapping by making use of established GIS environments and discuss methods of addressing data organization and mapping requirements by using an easily integrable datamodel that is - for the time being - designed as file-geodatabase (FileGDB) environment in ESRI's ArcGIS. A major design-driving requirement for this datamodel is its extensibility and scalability for growing scientific as well as technical needs, e.g., the utilization of such a datamodel for surface mapping of different planetary objects as defined by their respective reference system and by using different instrument data. Furthermore, it is a major goal to construct a generic model which allows to perform combined geologic as well as geomorphologic mapping tasks making use of international standards without loss of information and by maintaining topologic integrity. An integration of such a datamodel within a geospatial DBMS context can practically be performed by individuals as well as groups without having to deal with the details of administrative tasks and data ingestion issues. Besides the actual mapping, key components of such a mapping datamodel deal with the organization and search for image-sensor data and previous mapping efforts, as well as the proper organization of cartographic representations and assignments of geologic/geomorphologic units within their stratigraphic context.

Finite key analysis for symmetric attacks in quantum key distribution

DOE Office of Scientific and Technical Information (OSTI.GOV)

Meyer, Tim; Kampermann, Hermann; Kleinmann, Matthias

2006-10-15

We introduce a constructive method to calculate the achievable secret key rate for a generic class of quantum key distribution protocols, when only a finite number n of signals is given. Our approach is applicable to all scenarios in which the quantum state shared by Alice and Bob is known. In particular, we consider the six state protocol with symmetric eavesdropping attacks, and show that for a small number of signals, i.e., below n{approx}10{sup 4}, the finite key rate differs significantly from the asymptotic value for n{yields}{infinity}. However, for larger n, a good approximation of the asymptotic value is found.more » We also study secret key rates for protocols using higher-dimensional quantum systems.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yuan, Chris, E-mail: cyuan@uwm.edu; Wang, Endong; Zhai, Qiang

Temporal homogeneity of inventory data is one of the major problems in life cycle assessment (LCA). Addressing temporal homogeneity of life cycle inventory data is important in reducing the uncertainties and improving the reliability of LCA results. This paper attempts to present a critical review and discussion on the fundamental issues of temporal homogeneity in conventional LCA and propose a theoretical framework for temporal discounting in LCA. Theoretical perspectives for temporal discounting in life cycle inventory analysis are discussed first based on the key elements of a scientific mechanism for temporal discounting. Then generic procedures for performing temporal discounting inmore » LCA is derived and proposed based on the nature of the LCA method and the identified key elements of a scientific temporal discounting method. A five-step framework is proposed and reported in details based on the technical methods and procedures needed to perform a temporal discounting in life cycle inventory analysis. Challenges and possible solutions are also identified and discussed for the technical procedure and scientific accomplishment of each step within the framework. - Highlights: • A critical review for temporal homogeneity problem of life cycle inventory data • A theoretical framework for performing temporal discounting on inventory data • Methods provided to accomplish each step of the temporal discounting framework.« less

Issues in developing valid assessments of speech pathology students' performance in the workplace.

PubMed

McAllister, Sue; Lincoln, Michelle; Ferguson, Alison; McAllister, Lindy

2010-01-01

Workplace-based learning is a critical component of professional preparation in speech pathology. A validated assessment of this learning is seen to be 'the gold standard', but it is difficult to develop because of design and validation issues. These issues include the role and nature of judgement in assessment, challenges in measuring quality, and the relationship between assessment and learning. Valid assessment of workplace-based performance needs to capture the development of competence over time and account for both occupation specific and generic competencies. This paper reviews important conceptual issues in the design of valid and reliable workplace-based assessments of competence including assessment content, process, impact on learning, measurement issues, and validation strategies. It then goes on to share what has been learned about quality assessment and validation of a workplace-based performance assessment using competency-based ratings. The outcomes of a four-year national development and validation of an assessment tool are described. A literature review of issues in conceptualizing, designing, and validating workplace-based assessments was conducted. Key factors to consider in the design of a new tool were identified and built into the cycle of design, trialling, and data analysis in the validation stages of the development process. This paper provides an accessible overview of factors to consider in the design and validation of workplace-based assessment tools. It presents strategies used in the development and national validation of a tool COMPASS, used in an every speech pathology programme in Australia, New Zealand, and Singapore. The paper also describes Rasch analysis, a model-based statistical approach which is useful for establishing validity and reliability of assessment tools. Through careful attention to conceptual and design issues in the development and trialling of workplace-based assessments, it has been possible to develop the world's first valid and reliable national assessment tool for the assessment of performance in speech pathology.

The economics of biosimilars.

PubMed

Blackstone, Erwin A; Joseph, P Fuhr

2013-09-01

The high cost of pharmaceuticals, especially biologics, has become an important issue in the battle to control healthcare costs. The Hatch-Waxman Act encourages generic competition but still provides incentives for pioneers to develop new drugs. The Biologics Price Competition and Innovation Act is intended to do the same for biologics and biosimilars. To examine information related to biosimilars to determine their potential impact on competition in the biologic market. Using information concerning the European Union (EU) and the pharmaceutical industry, this article reviews and analyzes the experience of biosimilars in the EU, as well as the obstacles and opportunities that biosimilars face in the United States. Much of the analysis is based on examining current trends in biologic drugs and the potential implications on the future of biosimilars. This article reviews the mixed success of biosimilars in the EU and the implications for the United States. Because biologics are produced from living organisms, manufacturing issues are more important than in the chemical drug market. The barriers to biosimilar entry into the marketplace are much more difficult to overcome than challenges generic manufacturers typically face and are similar to obstacles specialty injectable producers encounter. The competitive responses by pioneers are also likely to be more important. The capital costs and risk issues with biosimilars make alliances and partnering arrangements very likely. Biosimilars often enter emerging markets, where the barriers to entry are easier to overcome. Nevertheless, the United States represents the greatest opportunity for biosimilar producers, in part because it is the largest biologics market and has high prices for biologics. As the United States enters the biosimilar market, the pharmaceutical industry is likely to grow at an accelerated pace. Automatic substitution is likely to be slow to develop, because of safety and quality concerns. The beneficial impact of biosimilars is likely to take a long time to be realized and to be fraught with more difficulties than was the case for small-molecule generics. Various factors, such as safety, pricing, manufacturing, entry barriers, physician acceptance, and marketing, will make the biosimilar market develop different from the generic market. The high cost to enter the market and the size of the biologic drug market make entry attractive but risky.

40 CFR 52.2122 - Approval status.

Code of Federal Regulations, 2010 CFR

2010-07-01

... sources covered by CTGs issued by the previous January. (b) EPA disapproved South Carolina's generic...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) South Carolina § 52.2122 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves South Carolina's plans for...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gaba, J.M.

Three areas are addressed in this paper: generic issues that arise simply in the process of decision-making under environmental statutes; different decision-making standards under various environmental statutes; and efforts to legislate a {open_quotes}safe{close_quotes} or {open_quotes}acceptable{close_quotes} risk from exposure to carcinogenic chemicals.

A generic nuclei detection method for histopathological breast images

NASA Astrophysics Data System (ADS)

Kost, Henning; Homeyer, André; Bult, Peter; Balkenhol, Maschenka C. A.; van der Laak, Jeroen A. W. M.; Hahn, Horst K.

2016-03-01

The detection of cell nuclei plays a key role in various histopathological image analysis problems. Considering the high variability of its applications, we propose a novel generic and trainable detection approach. Adaption to specific nuclei detection tasks is done by providing training samples. A trainable deconvolution and classification algorithm is used to generate a probability map indicating the presence of a nucleus. The map is processed by an extended watershed segmentation step to identify the nuclei positions. We have tested our method on data sets with different stains and target nuclear types. We obtained F1-measures between 0.83 and 0.93.

Cryptochrysa Freitas Penny, a generic homonym, replaced by Titanochrysa Sosa Freitas (Neuroptera: Chrysopidae).

PubMed

Tauber, Catherine A; Sosa, Francisco; Contreras-Ramos, Atilano

2018-01-24

The green lacewing genus name Cryptochrysa Freitas Penny 2001 is identified as a junior homonym of Cryptochrysa Hampson 1926 (Lepidoptera: Noctuidae). Moreover, Titanochrysa Sosa Freitas 2012 is determined to be an available junior synonym of Cryptochrysa Freitas Penny. Thus, Titanochrysa becomes the substitute name for the preoccupied generic name. Here, we also provide (i) new information and images for Titanochrysa chloros (Freitas Penny) comb. nov., the only species ever included in the chrysopid genus Cryptochrysa, (ii) a clarified set of diagnostic features for the reconstituted genus Titanochrysa, and (iii) a key and images for identifying the six described Titanochrysa species.

Bioequivalence of generic and branded amoxicillin capsules in healthy human volunteers

PubMed Central

Pathak, Priyanka; Pandit, Vijaya A.; Dhande, Priti P.

2017-01-01

CONTEXT: The Medical Council of India urges doctors to prescribe generic drugs as far as possible. The Indian Medical Association had responded earlier saying that it requires guarantees on the quality of generic forms of drugs. Although no published scientific reports are available on the issue of therapeutic inequivalence, unconfirmed clinician accounts and newspaper reports of therapeutic inequivalence exist. AIM: This study was planned to ascertain whether bioequivalence of branded and generic amoxicillin capsule is comparable. SETTINGS AND DESIGN: An open-label, randomized, single-dose, two-treatment, two-sequence, two-period crossover oral bioequivalence study was conducted in 12 healthy, adult human subjects under fasting condition. MATERIALS AND METHODS: Serum samples, collected at 8 time points, were analyzed by a validated ultraviolet spectrophotometer method. Pharmacokinetic (PK) parameters such as area under the curve (AUC)0–t, AUC0–∞, Cmax, and Tmax were determined along with time above minimum inhibitory concentration (MIC). STATISTICAL ANALYSIS USED: The log-transformed PK parameters (Cmax, AUC0–t, AUC0–∞) were analyzed using a Two One-Sided Test ANOVA in SAS for each parameter. Tmax and MIC were analyzed by Wilcoxon rank-sum test in GraphPad Prism. RESULTS: Geometric mean ratio of Cmax fell within bioequivalence criteria. The upper and lower confidence limits of both AUC0–t and AUC0–∞ geometric mean ratio fell below bioequivalence criteria. Time above MIC of generic preparation was significantly lower than that of branded version. CONCLUSIONS: The generic capsule was not bioequivalent to the branded amoxicillin capsule. PMID:28706331

[Pharmacoeconomic indicators of cardiovascular drug utilization in the Republic of Croatia and city of Zagreb in 2008].

PubMed

Stimac, Danijela; Stambuk, Ivanka

2010-12-01

In comparison with original drugs, generic drugs have the same efficacy but considerably lower price and should therefore be preferred to original drugs on prescribing. The aim of the present study was to assess outpatient utilization and rationality of cardiovascular drug prescribing in the City of Zagreb and Republic of Croatia based on the generic to original drug prescribing ratio. Data on the financial indicators and number of cardiovascular drug packages issued in 2008 were obtained from the Croatian Institute of Health Insurance. These data were used to calculate the number of defined daily doses (DDD) and number of DDD per 1000 inhabitants per day (DDD/1000/day). The index of generic/original drug utilization was determined for Zagreb and Croatia as a measure for assessment of prescribing rationality; the significance of difference was determined by X2-test. The rate of prescribing original cardiovascular drugs was significantly higher in Zagreb as compared with Croatia as a whole. The index of prescribing generic versus original drugs was 1.20 (249/208 DDD/1000/day) in Zagreb and 1.65 (249/151 DDD/1000/day) in Croatia. Difference in the utilization of generic drugs between Zagreb and Croatia as determined by X2-test (the level of statistical significance was set at P<0.05) was statistically significant (P=0.021). The highest differences were recorded in the most widely prescribed drug groups, i.e. ACE inhibitors with the generic/original drug index of 1.38 in Zagreb and 2.02 in Croatia; and hypolipemics with the generic/original drug index of 0.96 in Zagreb and 1.34 in Croatia. According to financial indicators, the generic/original drug index was 1.44 in Croatia and only 0.96 in Zagreb. The significantly greater influence of pharmaceutical industry marketing in Zagreb entailed the significantly higher rate of original drug prescribing, which is associated with considerably greater drug expenses. Measures to stimulate prescribing generic drugs should be launched at the national level.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Daling, P.M.; Marler, J.E.; Vo, T.V.

This study evaluates the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue 143, ``Availability of HVAC and Chilled Water Systems.`` The study identifies vulnerabilities related to failures of HVAC, chilled water, and room cooling systems; develops estimates of room heatup rates and safety-related equipment vulnerabilities following losses of HVAC/room cooler systems; develops estimates of the core damage frequencies and public risks associated with failures of these systems; develops three proposed resolution strategies to this generic issue; and performs a value/impact analysis of the proposed resolutions. Existing probabilistic risk assessments for four representative plants, including one plantmore » from each vendor, form the basis for the core damage frequency and public risk calculations. Both internal and external events were considered. It was concluded that all three proposed resolution strategies exceed the $1,000/person-rem cost-effectiveness ratio. Additional evaluations were performed to develop ``generic`` insights on potential design-related and configuration-related vulnerabilities and potential high-frequency ({approximately}1E-04/RY) accident sequences that involve failures of HVAC/room cooling functions. It was concluded that, although high-frequency accident sequences may exist at some plants, these high-frequency sequences are plant-specific in nature or have been resolved through hardware and/or operational changes. The plant-specific Individual Plant Examinations are an effective vehicle for identification and resolution of these plant-specific anomalies and hardware configurations.« less

Guiding Principles for Data Architecture to Support the Pathways Community HUB Model.

PubMed

Zeigler, Bernard P; Redding, Sarah; Leath, Brenda A; Carter, Ernest L; Russell, Cynthia

2016-01-01

The Pathways Community HUB Model provides a unique strategy to effectively supplement health care services with social services needed to overcome barriers for those most at risk of poor health outcomes. Pathways are standardized measurement tools used to define and track health and social issues from identification through to a measurable completion point. The HUB use Pathways to coordinate agencies and service providers in the community to eliminate the inefficiencies and duplication that exist among them. Experience with the Model has brought out the need for better information technology solutions to support implementation of the Pathways themselves through decision-support tools for care coordinators and other users to track activities and outcomes, and to facilitate reporting. Here we provide a basis for discussing recommendations for such a data infrastructure by developing a conceptual model that formalizes the Pathway concept underlying current implementations. The main contribution is a set of core recommendations as a framework for developing and implementing a data architecture to support implementation of the Pathways Community HUB Model. The objective is to present a tool for communities interested in adopting the Model to learn from and to adapt in their own development and implementation efforts. Experience with the Community Health Access Project (CHAP) data base system (the core implementation of the Model) has identified several issues and remedies that have been developed to address these issues. Based on analysis of issues and remedies, we present several key features for a data architecture meeting the just mentioned recommendations. Presentation of features is followed by a practical guide to their implementation allowing an organization to consider either tailoring off-the-shelf generic systems to meet the requirements or offerings that are specialized for community-based care coordination. Looking to future extensions, we discuss the utility and prospects for an ontology to include care coordination in the Unified Medical Language System (UMLS) of the National Library of Medicine and other existing medical and nursing taxonomies. Pathways structures are an important principle, not only for organizing the care coordination activities, but also for structuring the data stored in electronic form in the conduct of such care. We showed how the proposed architecture encourages design of effective decision support systems for coordinated care and suggested how interested organizations can set about acquiring such systems. Although the presentation focuses on the Pathways Community HUB Model, the principles for data architecture are stated in generic form and are applicable to any health information system for improving care coordination services and population health.

New tarsonemids associated with bark beetles (Acarina: Tarsonemidae)

Treesearch

Robert L. Smiley; John C. Moser

1973-01-01

The generic characters for Ununguitarsonemus beer and nucifora are emended and U. peacocki n. sp. is described. Descriptions and illustrations for Heterotarsonemus milleri and H. makaharai n. spp. are presented, as well as a key to species for this genus. A lectotype is designated for ...

Staff's perceptions of voluntary assertiveness skills training.

PubMed

McVanel, Sarah; Morris, Beth

2010-01-01

Clinicians' ability to be assertive when unsure or concerned about procedures, treatment modalities, or patients' symptoms is key in reducing risk and preventing sentinel events. In this article, the authors provide a framework for generic, voluntary assertiveness communication skills workshops that any educator can implement.

Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored

PubMed Central

López, René; Arriagada, Elizabeth; Carrasco, René; Gallardo, Natalia; Lorca, Eduardo

2017-01-01

Background. Tacrolimus is the primary immunosuppressive drug used in kidney transplant patients. Replacing brand name products with generics is a controversial issue that we studied after a Chilean Ministry of Health mandate to implement such a switch. Methods. Forty-one stable Prograf (Astellas) receiving kidney transplant patients were switched to a generic tacrolimus (Sandoz) in a 1 : 1 dose ratio and were followed up for up to 8 months. All other drugs were maintained as per normal practice. Results. Neither tacrolimus doses nor their trough blood levels changed significantly after the switch, but serum creatinine did: 1.62 ± 0.90 versus 1.75 ± 0.92 mg/dL (p < 0.001). At the same time, five graft biopsies were performed, and two of them showed cellular acute rejection. There were nine infectious episodes treated satisfactorily with proper therapies. No patient or graft was lost during the follow-up time period. Conclusion. Switching from brand name tacrolimus to a generic tacrolimus (Sandoz) is feasible and appears to be safe, but it must be monitored carefully by treating physicians. PMID:28246556

Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored.

PubMed

González, Fernando; López, René; Arriagada, Elizabeth; Carrasco, René; Gallardo, Natalia; Lorca, Eduardo

2017-01-01

Background . Tacrolimus is the primary immunosuppressive drug used in kidney transplant patients. Replacing brand name products with generics is a controversial issue that we studied after a Chilean Ministry of Health mandate to implement such a switch. Methods . Forty-one stable Prograf (Astellas) receiving kidney transplant patients were switched to a generic tacrolimus (Sandoz) in a 1 : 1 dose ratio and were followed up for up to 8 months. All other drugs were maintained as per normal practice. Results . Neither tacrolimus doses nor their trough blood levels changed significantly after the switch, but serum creatinine did: 1.62 ± 0.90 versus 1.75 ± 0.92 mg/dL ( p < 0.001). At the same time, five graft biopsies were performed, and two of them showed cellular acute rejection. There were nine infectious episodes treated satisfactorily with proper therapies. No patient or graft was lost during the follow-up time period. Conclusion . Switching from brand name tacrolimus to a generic tacrolimus (Sandoz) is feasible and appears to be safe, but it must be monitored carefully by treating physicians.

Psychometric properties of the self-report Malay version of the Pediatric Quality of Life (PedsQLTM) 4.0 Generic Core Scales among multiethnic Malaysian adolescents.

PubMed

Ainuddin, Husna A; Loh, Siew Yim; Chinna, Karuthan; Low, Wah Yun; Roslani, April Camilla

2015-06-01

Adolescence is the potential period for growth and optimal functioning, but developmental issues like time of transition from childhood to adulthood will create stress and affect the adolescent's quality of life (QOL). However, there is a lack of research tool for measuring adolescent's QOL in Malaysia. The aim of the study was to determine the validity and reliability of the self-report Malay version of the pediatric QOL (PedsQL™) 4.0 Generic Core Scales in assessing the QOL of Malaysian adolescents. A cross-sectional study design using the 23-item self-report Malay version of the PedsQL 4.0 Generic Core Scales was administered on a convenient cluster sampling (n = 297 adolescent) from a secondary school. The internal consistency reliability had Cronbach's α values ranging from .70 to .89. Factor analysis reported a six-factor structure via principal axis factor analysis. In conclusion, the self-report Malay version of the pediatric QOL 4.0 Generic Core Scales is a reliable and valid tool to measure the QOL of multiethnic Malaysian adolescents. © The Author(s) 2013.

Towards a new generation of mission planning systems: Flexibility and performance

NASA Technical Reports Server (NTRS)

Gasquet, A.; Parrod, Y.; Desaintvincent, A.

1994-01-01

This paper presents some new approaches which are required for a better adequacy of Mission Planning Systems. In particular, the performance flexibility and genericity issues are discussed based on experience acquired through various Mission Planning systems developed by Matra Marconi Space.

76 FR 41154 - Review and Approval of Projects

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-13

... development project to an out-of-basin treatment or disposal facility; insert language authorizing ``renewal... formations that may be the subject of natural gas development using hydrofracture stimulation and replace with a generic category-- ``unconventional natural gas development;'' broaden the scope of ABRs issued...

The balance between innovation and competition: the Hatch-Waxman Act, the 2003 Amendments, and beyond.

PubMed

Kelly, Colleen

2011-01-01

In 1984, Congress passed the Hatch-Waxman Act, a landmark statute designed both to encourage innovation by pioneer drug companies and to increase competition by generic drug companies. After its enactment, drug companies attempted to "ga the regulatory regime to their respective economic advantage. In 2003, in an effort to address these issues, FDA promulgated a final rule and Congress passed the Medicare Modernization Act, amending the Hatch-Waxman Act. This article provides a comprehensive look at the 2003 statutory and regulatory changes. First, the article analyzes the history and provisions of the original Hatch-Waxman Act and the issues that arose after its enactment. Second, the article discusses the passage of the 2003 FDA rule and the 2003 Medicare Modernization Act. Next, the article demonstrates that, although the 2003 amendments may have definitively resolved some issues, the amendments did not resolve all interpretive issues and have even led to unintended consequences. In particular, the article discusses several areas of current controversy, including the effect of patent delisting and patent expiration on 180-day exclusivity, the patent delisting counterclaim provision, the declaratory judgment action provision, patent settlement agreements, and authorized generics. Finally, the article assesses the potential for future reform of the Hatch-Waxman Act. The article concludes that maintaining the balance between innovation and competition will likely remain a daunting task for legislators and regulators in the future.

Design and Development of Card-Sized Virtual Keyboard Using Permanent Magnets and Hall Sensors

NASA Astrophysics Data System (ADS)

Demachi, Kazuyuki; Ohyama, Makoto; Kanemoto, Yoshiki; Masaie, Issei

This paper proposes a method to distinguish the key-type of human fingers attached with the small permanent magnets. The Hall sensors arrayed in the credit card size area feel the distribution of the magnetic field due to the key-typing movement of the human fingers as if the keyboard exists, and the signal is analyzed using the generic algorithm or the neural network algorism to distinguish the typed keys. By this method, the keyboard can be miniaturized to the credit card size (54mm×85mm). We called this system `The virtual keyboard system'.

Encryption key distribution via chaos synchronization

NASA Astrophysics Data System (ADS)

Keuninckx, Lars; Soriano, Miguel C.; Fischer, Ingo; Mirasso, Claudio R.; Nguimdo, Romain M.; van der Sande, Guy

2017-02-01

We present a novel encryption scheme, wherein an encryption key is generated by two distant complex nonlinear units, forced into synchronization by a chaotic driver. The concept is sufficiently generic to be implemented on either photonic, optoelectronic or electronic platforms. The method for generating the key bitstream from the chaotic signals is reconfigurable. Although derived from a deterministic process, the obtained bit series fulfill the randomness conditions as defined by the National Institute of Standards test suite. We demonstrate the feasibility of our concept on an electronic delay oscillator circuit and test the robustness against attacks using a state-of-the-art system identification method.

Framework Thinking, Subject Thinking and "Taiwan-"ness"" in Environmental Education

ERIC Educational Resources Information Center

Yueh, Mei-Chun Michelle; Barker, Miles

2011-01-01

In the 1998 Taiwanese national curriculum revision, environmental education was one of six new "Important Issues". To some early observers, the generic "framework" sections of this 1998 curriculum (Aims, Goals, Core Competences) resonated well with the integrative and transdisciplinary nature of environmental education. This…

SEL Ada reuse analysis and representations

NASA Technical Reports Server (NTRS)

Kester, Rush

1990-01-01

Overall, it was revealed that the pattern of Ada reuse has evolved from initial reuse of utility components into reuse of generalized application architectures. Utility components were both domain-independent utilities, such as queues and stacks, and domain-specific utilities, such as those that implement spacecraft orbit and attitude mathematical functions and physics or astronomical models. The level of reuse was significantly increased with the development of a generalized telemetry simulator architecture. The use of Ada generics significantly increased the level of verbatum reuse, which is due to the ability, using Ada generics, to parameterize the aspects of design that are configurable during reuse. A key factor in implementing generalized architectures was the ability to use generic subprogram parameters to tailor parts of the algorithm embedded within the architecture. The use of object oriented design (in which objects model real world entities) significantly improved the modularity for reuse. Encapsulating into packages the data and operations associated with common real world entities creates natural building blocks for reuse.

Translating Genius: The Importance Of The Relationship Between Military Geniuses And A Key - Subordinate

DTIC Science & Technology

2014-04-01

reference to both the subjects of the research (who are all men ) and in reference to hypothetical, generic genius to key- subordinate relationships. These... men who so dominated the battlefield that they have come to be archetypes of personality and to even define entire ages of warfare. Brash, aggressive...great men , and their light burns so bright that their vision and will is single-handedly imposed upon their enemies? Or is there something more

Feasibility, reliability, and validity of the Pediatric Quality of Life Inventory ™ generic core scales, cancer module, and multidimensional fatigue scale in long-term adult survivors of pediatric cancer.

PubMed

Robert, Rhonda S; Paxton, Raheem J; Palla, Shana L; Yang, Grace; Askins, Martha A; Joy, Shaini E; Ater, Joann L

2012-10-01

Most health-related quality of life assessments are designed for either children or adults and have not been evaluated for adolescent and young adult survivors of pediatric cancer. The objective of this study was to examine the feasibility, reliability, and validity of the Pediatric Quality of Life Inventory (PedsQL ™ Generic Core Scales, Cancer Module, and Multidimensional Fatigue Scale in adult survivors of pediatric cancer. Adult survivors (n = 64; Mean age 35 year old; >2 years after treatment) completed the PedsQL™ Generic Core Scales, Cancer Module, and Multidimensional Fatigue Scale. Feasibility was examined with floor and ceiling effects; and internal consistency was determined by Cronbach's coefficient alpha calculations. Inter-factor correlations were also assessed. Significant ceiling effects were observed for the scales of social function, nausea, procedural anxiety, treatment anxiety, and communication. Internal consistency for all subscales was within the recommended ranges (α ≥ 0.70). Moderate to strong correlations between most Cancer Module and Generic Core Scales (r = 0.25 to r = 0.76) and between the Multidimensional Fatigue Scale and Generic Core Scales (r = 0.37 to r = 0.73). The PedsQL™ Generic Core Scales, Cancer Module, and Multidimensional Fatigue Scale appear to be feasible for an older population of pediatric cancer survivors; however, some of the Cancer Module Scales (nausea, procedural/treatment anxiety, and communication) were deemed not relevant for long-term survivors. More information is needed to determine whether the issues addressed by these modules are meaningful to long-term adult survivors of pediatric cancers. Copyright © 2012 Wiley Periodicals, Inc.

[Users sceptical about generic drugs: an anthropological approach].

PubMed

Sarradon-Eck, A; Blanc, M-A; Faure, M

2007-06-01

Since the enactment of the 2002 legislative measures favoring the prescription of generic drugs, various quantitative studies have shown that approval by prescribers and users has risen in France. Nevertheless, scepticism remains as well as distrust towards these drugs focusing on their effectiveness compared with brand-name drugs, on potential dangers, and on the interruption they cause in prescription and consumption habits. Using a comprehensive approach, this article analyzes the social and cultural logic behind the negative image of generic drugs. The materials issued from an ethnographic study on the prescription of drugs for high blood pressure. Sixty-eight interviews were undertaken between April 2002 and October 2004 with people (39 women and 29 men, between the age of 40 and 95, 52 over the age of 60) treated for over a year for high blood pressure in rural areas in the Southeast of France. Thirteen people provided unsolicited opinions about generic drugs. Analysis of the information collected shows that users have various representations of generic drugs, including the idea of counterfeited and foreign drugs. These representations interfere with the adjustment process and the development of consumer loyalty. They are part of a set of social representations about drugs which form and express the user's reality. In these representations, the drug is an ambivalent object, carrier of both biological effectiveness and toxicity; it is also the metonymical extension of the prescriber, bestowing upon the prescription a symbolic value. By placing the generic drug in its network of symbolic and social meaning, this study highlights the coherence of the scepticism towards generic drugs by consumers (and prescribers) with a system of common opinion in which drugs are everyday things, personalized and compatible with users, symbolic exchange carriers in the physician-patient relationship, and in which confidence in the drug is also that given to the health care system in general.

Diversity and Social Justice Implications for Outcome Approaches to Evaluation

ERIC Educational Resources Information Center

Arthur, Nancy; Lalande, Vivian

2009-01-01

It is important that counsellors provide evidence regarding the efficacy of their services. Although there has been an increased focus on generic outcome measurement of counselling programs and services, little attention has been paid to accountability issues for meeting the needs of diverse populations. This article highlights the increasing…

Best Practices: Power Quality and Integrated Testing at JSC

NASA Technical Reports Server (NTRS)

Davis, Lydia

2018-01-01

This presentation discusses Best Practices for Power Quality and Integrated Testing at JSC in regards to electrical systems. These high-level charts include mostly generic information; however, a specific issue is discussed involving flight hardware that could have been discovered prior to flight with an integrated test.

Inclusion of Adults with Disability in Australia: Outcomes, Legislation and Issues

ERIC Educational Resources Information Center

Stancliffe, Roger J.

2014-01-01

This paper focuses on adults with disability and their inclusion in Australian society by examining various outcomes: community living, community participation and inclusive social roles such as open (competitive) employment, participation in university education, as well as use of generic community services like public transport. Australian…

Online Collaborative Communities of Learning for Pre-Service Teachers of Languages

ERIC Educational Resources Information Center

Morgan, Anne-Marie

2015-01-01

University programs for preparing preservice teachers of languages for teaching in schools generally involve generic pedagogy, methodology, curriculum, programming and issues foci, that provide a bridge between the study of languages (or recognition of existing language proficiency) and the teaching of languages. There is much territory to cover…

Information Services at the Nuclear Safety Analysis Center.

ERIC Educational Resources Information Center

Simard, Ronald

This paper describes the operations of the Nuclear Safety Analysis Center. Established soon after an accident at the Three Mile Island nuclear power plant near Harrisburg, Pennsylvania, its efforts were initially directed towards a detailed analysis of the accident. Continuing functions include: (1) the analysis of generic nuclear safety issues,…

Prescription Drug Benefits: Cost Management Issues for Medicare

PubMed Central

Fox, Peter D.

2003-01-01

Little attention has been devoted in policy circles as to how Medicare would manage an outpatient prescription drug benefit. This article, first, discusses the role of the pharmacy benefits manager (PBM), the entity that processes claims and otherwise helps administer the benefit. It then discusses the major decisions that will be necessary regarding such matters as: which drugs should be covered; how broad should the pharmacy network be; whether there should be incentives to obtain generic rather than brand-name drugs when available; for drugs with no generic equivalent, should there be incentives to obtain less expensive, medically appropriate brand-name drugs; and how should prescription drug utilization be managed. PMID:15124374

Efficacy of generic allometric equations for estimating biomass: a test in Japanese natural forests.

PubMed

Ishihara, Masae I; Utsugi, Hajime; Tanouchi, Hiroyuki; Aiba, Masahiro; Kurokawa, Hiroko; Onoda, Yusuke; Nagano, Masahiro; Umehara, Toru; Ando, Makoto; Miyata, Rie; Hiura, Tsutom

2015-07-01

Accurate estimation of tree and forest biomass is key to evaluating forest ecosystem functions and the global carbon cycle. Allometric equations that estimate tree biomass from a set of predictors, such as stem diameter and tree height, are commonly used. Most allometric equations are site specific, usually developed from a small number of trees harvested in a small area, and are either species specific or ignore interspecific differences in allometry. Due to lack of site-specific allometries, local equations are often applied to sites for which they were not originally developed (foreign sites), sometimes leading to large errors in biomass estimates. In this study, we developed generic allometric equations for aboveground biomass and component (stem, branch, leaf, and root) biomass using large, compiled data sets of 1203 harvested trees belonging to 102 species (60 deciduous angiosperm, 32 evergreen angiosperm, and 10 evergreen gymnosperm species) from 70 boreal, temperate, and subtropical natural forests in Japan. The best generic equations provided better biomass estimates than did local equations that were applied to foreign sites. The best generic equations included explanatory variables that represent interspecific differences in allometry in addition to stem diameter, reducing error by 4-12% compared to the generic equations that did not include the interspecific difference. Different explanatory variables were selected for different components. For aboveground and stem biomass, the best generic equations had species-specific wood specific gravity as an explanatory variable. For branch, leaf, and root biomass, the best equations had functional types (deciduous angiosperm, evergreen angiosperm, and evergreen gymnosperm) instead of functional traits (wood specific gravity or leaf mass per area), suggesting importance of other traits in addition to these traits, such as canopy and root architecture. Inclusion of tree height in addition to stem diameter improved the performance of the generic equation only for stem biomass and had no apparent effect on aboveground, branch, leaf, and root biomass at the site level. The development of a generic allometric equation taking account of interspecific differences is an effective approach for accurately estimating aboveground and component biomass in boreal, temperate, and subtropical natural forests.

Evaluation of the clinical and economic impact of a brand name-to-generic warfarin sodium conversion program.

PubMed

Witt, Daniel M; Tillman, Donald J; Evans, Christy M; Plotkin, Tatyana V; Sadler, Melanie A

2003-03-01

Substitution of generic warfarin initially was discouraged because of concerns regarding therapeutic failure or toxicity. Although subsequent research with AB-rated (i.e., bioequivalent) warfarin did not confirm initial concerns, the issue is not settled for all clinicians. We sought to provide additional information regarding the clinical and economic impact of warfarin conversion by analyzing a real-life sample of patients receiving long-term anticoagulation therapy who were switched from brand name to generic warfarin. Patients who had been taking warfarin for at least 180 days and had received uninterrupted oral anticoagulation 90 days before and 90 days after switching to generic warfarin were included. The switch date was based on the first time generic warfarin was dispensed from our pharmacies. The primary end point was the calculated amount of time each patient's international normalized ratio (INR) values were within the patient-specific target INR range in the 90 days before and after the switch. Data regarding adverse events and medical resource utilization were also collected. Pharmacoeconomic analyses were performed. The analysis included 2299 patients. The overall difference in calculated time INR values were below (22.6% before vs 26.1% after switch, p<0.0001) and within (65.9% before vs 63.3% after switch, p=0.0002) the therapeutic INR range was statistically but not clinically significant. Only 28.0% of patients experienced a change in therapeutic INR control of 10% or less, 33.1% experienced INR control that improved by greater than 10%, and 38.9% experienced INR control that worsened by more than 10%. The difference in total treatment costs associated with brand name and generic warfarin was 3128 dollars/100 patient-years in favor of the generic product. Sensitivity analyses revealed that cost savings associated with warfarin conversion in this health care system were highly dependent on the difference between warfarin costs and cost of treating anticoagulation-related adverse events. Most of these patients were successfully switched from brand name to generic warfarin. However, supplemental INR monitoring is warranted when one warfarin product is substituted for another to allow timely detection of those patients who experience significant changes in anticoagulation response.

Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials.

PubMed

Zheng, Nan; Sun, Dajun D; Zou, Peng; Jiang, Wenlei

2017-05-01

In the past few decades, the development of medicine at the nanoscale has been applied to oral and parenteral dosage forms in a wide range of therapeutic areas to enhance drug delivery and reduce toxicity. An obvious response to these benefits is reflected in higher market shares of complex drug products containing nanomaterials than that of conventional formulations containing the same active ingredient. The surging market interest has encouraged the pharmaceutical industry to develop cost-effective generic versions of complex drug products based on nanotechnology when the associated patent and exclusivity on the reference products have expired. Due to their complex nature, nanotechnology-based drugs present unique challenges in determining equivalence standards between generic and innovator products. This manuscript attempts to provide the scientific rationales and regulatory considerations of key equivalence standards (e.g., in vivo studies and in vitro physicochemical characterization) for oral drugs containing nanomaterials, iron-carbohydrate complexes, liposomes, protein-bound drugs, nanotube-forming drugs, and nano emulsions. It also presents active research studies in bridging regulatory and scientific gaps for establishing equivalence of complex products containing nanomaterials. We hope that open communication among industry, academia, and regulatory agencies will accelerate the development and approval processes of generic complex products based on nanotechnology.

Politics and care: a study of Czech Americans within Leininger's theory of culture care diversity and universality.

PubMed

Miller, J

1997-01-01

The domain of inquiry for this study was the influence of the American political environmental context on professional and generic care patterns, expressions, and meanings of Czech American immigrants. The purpose of the research was to document, describe, interpret, and analyze the diversities and universalities of professional and generic care for this cultural group, to provide culturally congruent care to Czech Americans, and to explicate the role of politics as an influence on care patterns, health, and well being. The researcher's former transcultural ethnonursing study in Prague, Czechoslovakia in 1991 served as a stimulus for this in-depth study on politics and care. Twelve key and twenty general informants were interviewed. Five major themes were identified. The researcher discovered that the capitalist economic market structure of the United States influenced informant lifeways in all dimensions of Leininger's Theory of Culture Care Diversity and Universality, as depicted in the Sunrise Model. Specific care patterns discovered included care as choice, care as responsibility, and care as helping each other. Findings related to professional and generic care supported researcher predictions that generic culture care patterns would be important to immigrants. Provisions for culturally congruent nursing care were articulated based on research findings.

Harm reduction in name, but not substance: a comparative analysis of current Canadian provincial and territorial policy frameworks.

PubMed

Hyshka, Elaine; Anderson-Baron, Jalene; Karekezi, Kamagaju; Belle-Isle, Lynne; Elliott, Richard; Pauly, Bernie; Strike, Carol; Asbridge, Mark; Dell, Colleen; McBride, Keely; Hathaway, Andrew; Wild, T Cameron

2017-07-26

In Canada, funding, administration, and delivery of health services-including those targeting people who use drugs-are primarily the responsibility of the provinces and territories. Access to harm reduction services varies across jurisdictions, possibly reflecting differences in provincial and territorial policy commitments. We examined the quality of current provincial and territorial harm reduction policies in Canada, relative to how well official documents reflect internationally recognized principles and attributes of a harm reduction approach. We employed an iterative search and screening process to generate a corpus of 54 provincial and territorial harm reduction policy documents that were current to the end of 2015. Documents were content-analyzed using a deductive coding framework comprised of 17 indicators that assessed the quality of policies relative to how well they described key population and program aspects of a harm reduction approach. Only two jurisdictions had current provincial-level, stand-alone harm reduction policies; all other documents were focused on either substance use, addiction and/or mental health, or sexually transmitted and/or blood-borne infections. Policies rarely named specific harm reduction interventions and more frequently referred to generic harm reduction programs or services. Only one document met all 17 indicators. Very few documents acknowledged that stigma and discrimination are issues faced by people who use drugs, that not all substance use is problematic, or that people who use drugs are legitimate participants in policymaking. A minority of documents recognized that abstaining from substance use is not required to receive services. Just over a quarter addressed the risk of drug overdose, and even fewer acknowledged the need to apply harm reduction approaches to an array of drugs and modes of use. Current provincial and territorial policies offer few robust characterizations of harm reduction or go beyond rhetorical or generic support for the approach. By endorsing harm reduction in name, but not in substance, provincial and territorial policies may communicate to diverse stakeholders a general lack of support for key aspects of the approach, potentially challenging efforts to expand harm reduction services.

Collective attacks and unconditional security in continuous variable quantum key distribution.

PubMed

Grosshans, Frédéric

2005-01-21

We present here an information theoretic study of Gaussian collective attacks on the continuous variable key distribution protocols based on Gaussian modulation of coherent states. These attacks, overlooked in previous security studies, give a finite advantage to the eavesdropper in the experimentally relevant lossy channel, but are not powerful enough to reduce the range of the reverse reconciliation protocols. Secret key rates are given for the ideal case where Bob performs optimal collective measurements, as well as for the realistic cases where he performs homodyne or heterodyne measurements. We also apply the generic security proof of Christiandl et al. to obtain unconditionally secure rates for these protocols.

Encryption key distribution via chaos synchronization

PubMed Central

Keuninckx, Lars; Soriano, Miguel C.; Fischer, Ingo; Mirasso, Claudio R.; Nguimdo, Romain M.; Van der Sande, Guy

2017-01-01

We present a novel encryption scheme, wherein an encryption key is generated by two distant complex nonlinear units, forced into synchronization by a chaotic driver. The concept is sufficiently generic to be implemented on either photonic, optoelectronic or electronic platforms. The method for generating the key bitstream from the chaotic signals is reconfigurable. Although derived from a deterministic process, the obtained bit series fulfill the randomness conditions as defined by the National Institute of Standards test suite. We demonstrate the feasibility of our concept on an electronic delay oscillator circuit and test the robustness against attacks using a state-of-the-art system identification method. PMID:28233876

The Economics of Biosimilars

PubMed Central

Blackstone, Erwin A.; Joseph, P. Fuhr

2013-01-01

Background The high cost of pharmaceuticals, especially biologics, has become an important issue in the battle to control healthcare costs. The Hatch-Waxman Act encourages generic competition but still provides incentives for pioneers to develop new drugs. The Biologics Price Competition and Innovation Act is intended to do the same for biologics and biosimilars. Objective To examine information related to biosimilars to determine their potential impact on competition in the biologic market. Method Using information concerning the European Union (EU) and the pharmaceutical industry, this article reviews and analyzes the experience of biosimilars in the EU, as well as the obstacles and opportunities that biosimilars face in the United States. Much of the analysis is based on examining current trends in biologic drugs and the potential implications on the future of biosimilars. Discussion This article reviews the mixed success of biosimilars in the EU and the implications for the United States. Because biologics are produced from living organisms, manufacturing issues are more important than in the chemical drug market. The barriers to biosimilar entry into the marketplace are much more difficult to overcome than challenges generic manufacturers typically face and are similar to obstacles specialty injectable producers encounter. The competitive responses by pioneers are also likely to be more important. The capital costs and risk issues with biosimilars make alliances and partnering arrangements very likely. Biosimilars often enter emerging markets, where the barriers to entry are easier to overcome. Nevertheless, the United States represents the greatest opportunity for biosimilar producers, in part because it is the largest biologics market and has high prices for biologics. As the United States enters the biosimilar market, the pharmaceutical industry is likely to grow at an accelerated pace. Automatic substitution is likely to be slow to develop, because of safety and quality concerns. The beneficial impact of biosimilars is likely to take a long time to be realized and to be fraught with more difficulties than was the case for small-molecule generics. Conclusion Various factors, such as safety, pricing, manufacturing, entry barriers, physician acceptance, and marketing, will make the biosimilar market develop different from the generic market. The high cost to enter the market and the size of the biologic drug market make entry attractive but risky. PMID:24991376

Does Question Wording Predict Support for the Affordable Care Act? An Analysis of Polling During the Implementation Period, 2010-2016.

PubMed

Holl, Kristen; Niederdeppe, Jeff; Schuldt, Jonathon P

2018-07-01

The Patient Protection and Affordable Care Act (ACA) continues to be the subject of fierce political debate in the United States. Drawing on issue framing theory, together with research on wording effects in survey responding, we tested how common differences in the wording of ACA surveys relate to apparent public support for the law. We report on a content analysis of N = 376 U.S. national opinion surveys fielded during a more than six-year period, beginning 23 March 2010 (when President Obama signed the bill into law) and ending 8 November 2016 (Election Day), and use ordinary least squares (OLS) regression models to predict public support for the law as a function of variation in question wording. We coded questions gauging general sentiment toward the law for differences in issue labeling (e.g., Obamacare, Affordable Care Act), whether or not they referenced particular political entities (e.g., President Obama, Congress) or segments of the public (e.g., You, Your Family), various opinion metrics (e.g., Support, Favor), and different response options (e.g., Repeal, Expand) which we used to model aggregate levels of support. The results revealed several key differences in question wording-for example, generic references to the Healthcare Law were employed much more frequently than Obamacare or Affordable Care Act-a number of which reliably predicted aggregate levels of public support. The discussion considers possible explanations for these patterns and reiterates the value of attending to questionnaire design features when interpreting survey data about politically contentious health policy issues.

Sympotthastia wuyiensis sp. n. from China, with description of the immature stages of S. takatensis (Tokunaga) (Diptera, Chironomidae).

PubMed

Liu, Wenbin; Ferrington, Leonard C Jr; Wang, Xinhua

2016-06-20

Sympotthastia wuyiensis sp. n. is described and illustrated as male imago from China. The immature stages of S. takatensis (Tokunaga) are described. The generic diagnosis is emended. Key to the known adult males, larvae and pupae of the genus worldwide is presented.

A new species of Burumoseria Csiki, 1939 from Taiwan, with redescription of the genus and new generic synonym (Coleoptera: Chrysomelidae: Galerucinae: Alticini)

USDA-ARS?s Scientific Manuscript database

The Oriental genus Burumoseria Csiki is redescribed. A new species, Burumoseria yuae from Taiwan is described and illustrated. A key to Burumoseria species is provided. The Oriental and Australian genus Licyllus Jacoby 1885 is synonymized with Thrasychroma Jacoby 1885....

Multiple Cultures of Doing Geography Facilitate Global Studies

ERIC Educational Resources Information Center

Ahamer, Gilbert

2013-01-01

Purpose: This article aims to explain why geography is a prime discipline for analysing globalisation and a multicultural view of Global Studies. The generic approach of human geography to first select an appropriate methodology is taken as a key approach. Design/methodology/approach: Concepts from aggregate disciplines such as history, economics,…

From Access to Success: An Integrated Approach to Quality Higher Education Informed by Social Inclusion Theory and Practice

ERIC Educational Resources Information Center

Gidley, Jennifer M.; Hampson, Gary P.; Wheeler, Leone; Bereded-Samuel, Elleni

2010-01-01

Equitable access, success and quality in higher education are examined from a variety of ideological perspectives. "Quality" is positioned as a complex generic concept while "access" and "success" are identified as key concepts in the social inclusion domain, supplemented by the concept of "participation."…

A Guide to the Common Diatoms at Water Pollution Surveillance System Stations.

ERIC Educational Resources Information Center

Weber, Cornelius I.

This guide was developed by the United States Environmental Protection Agency (EPA) as a taxonomic reference for the identification of diatoms. The taxonomic information included consists of a generic key to the common genera of diatoms, a section illustrating 164 diatom species representing 43 common genera found at the Water Pollution…

78 FR 44157 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Generic...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-23

... key research questions. Qualitative information collected from site visits is a critical data source... September 23, 2013. ADDRESSES: You may submit comments by either one of the following methods: Email: Javar.... Instructions: Please submit one copy of your comments by only one method. All submissions received must include...

New generic synonyms in the Palaeotropical genus Urothrips (Thysanoptera: Phlaeothripinae) with one new species from Seychelles.

PubMed

Ulitzka, Manfred R; Mound, Laurence A

2014-01-28

Urothrips kobroi sp. n. is described from Seychelles, and reasons are given for considering Biconothrips Stannard and Coxothrips Bournier as new synonyms of Urothrips Bagnall. This genus now includes nine species, distributed between Africa and Australia, and a key to these species is provided.

Cognitive representations of flight-deck information attributes

NASA Technical Reports Server (NTRS)

Ricks, Wendell R.; Jonsson, Jon E.; Rogers, William H.

1994-01-01

A large number of aviation issues are generically being called fligh-deck information management issues, underscoring the need for an organization or classification structure. One objective of this study was to empirically determine how pilots organize flight-deck information attributes and -- based upon that data -- develop a useful taxonomy (in terms of better understanding the problems and directing solutions) for classifying flight-deck information management issues. This study also empirically determined how pilots model the importance of flight-deck information attributes for managing information. The results of this analysis suggest areas in which flight-deck researchers and designers may wish to consider focusing their efforts.

New drugs from old.

PubMed

2006-10-01

The NHS spends over pound10 billion each year on medicines. The use of generic (patent-expired) medicines rather than branded equivalents has a key role in containing this expenditure and ensuring best value for money. On average, 4 years after the patent of a branded medicine has expired in the UK, generic equivalents will account for around half of the drug's market and cost about a quarter as much as the original brand. This represents a potentially large loss of income and, therefore, a major concern for companies that market branded products. Consequently, many use a long-term strategy known as 'lifecycle management' to minimise loss and to maximise returns from such products. This encompasses prioritising products for development, forming strategic alliances with other companies to share resourses, and utilising legal processes to protect products. One part of this strategy is the development and intensive marketing of new formulations or derivatives of existing medicines nearing the end of their patent life. Here we highlight some key examples of the impact the marketing of such products can have on patients, prescribers and the NHS.

Cost-Effectiveness of Evaluating the New Technologies.

ERIC Educational Resources Information Center

Kastner, Theodore A.

1997-01-01

This commentary on a study comparing use of the brand name drug Depakene with generic valproic acid to control seizures in people with mental retardation focuses on issues of cost-effectiveness. It notes existing guidelines for pharmacoeconomic evaluation and suggests a possible model to include a threshold price (per quality-adjusted life year)…

Developing a User Oriented Design Methodology for Learning Activities Using Boundary Objects

ERIC Educational Resources Information Center

Fragou, ?lga; Kameas, Achilles

2013-01-01

International Standards in High and Open and Distance Education are used for developing Open Educational Resources (OERs). Current issues in e-learning community are the specification of learning chunks and the definition of describing designs for different units of learning (activities, units, courses) in a generic though expandable format.…

78 FR 33120 - Final Interim Staff Guidance LR-ISG-2011-04; Updated Aging Management Criteria for Reactor Vessel...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-03

..., ``Generic Aging Lessons Learned Report'' (GALL Report), for the aging management of Pressurized Water... communicate insights and lessons learned and to address emergent issues not covered in license renewal... ensure that PWR license renewal applicants will adequately address age-related degradation and aging...

Phytosanitary of irradiation of fresh tropical commodities in Hawaii: generic treatments, commercial adoption and current issues

USDA-ARS?s Scientific Manuscript database

Hawaii Pride is a pioneer in the use of phytosanitary irradiation. The commercial x-ray irradiation facility , Hawaii Pride LLC, has been shipping papaya and other tropical fruits and vegetables to the United States mainland using irradiation for 11 years. Irradiation is an approved treatment to con...

Generic Pronouns and Gender-Inclusive Language Reform in the English of Singapore and the Philippines

ERIC Educational Resources Information Center

Pauwels, Anne; Winter, Joanne

2004-01-01

The concurrent trends of globalisation and "indigenisation" affecting the English language (varieties) around the world pose some interesting questions for language planning and reform issues (e.g. Phillipson, 1992; Pennycook, 1994; Crystal, 1997). With this project we examine the impact of these competing trends on "corpus…

76 FR 57006 - Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX; NRC Regulation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-15

... amended its regulations to include jurisdiction over discrete sources of radium-226, accelerator-produced radioactive materials, and discrete sources of naturally occurring radioactive material, as required by the... those discrete sources of radium-226 under military control that are subject to NRC regulation, as...

78 FR 37848 - ASME Code Cases Not Approved for Use

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-24

...The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-1233, ``ASME Code Cases not Approved for Use.'' This regulatory guide lists the American Society of Mechanical Engineers (ASME) Code Cases that the NRC has determined not to be acceptable for use on a generic basis.

The Inter-Temporal Aspect of Well-Being and Societal Progress

ERIC Educational Resources Information Center

Sicherl, Pavle

2007-01-01

The perceptions on well-being and societal progress are influenced also by the quantitative indicators and measures used in the measurement, presentation and semantics of discussing these issues. The article presents a novel generic statistical measure S-time-distance, with clear interpretability that delivers a broader concept to look at data, to…

Encouraging Postgraduate Students of Literature and Art to Cross Conceptual Thresholds

ERIC Educational Resources Information Center

Wisker, Gina; Robinson, Gillian

2009-01-01

Much research into postgraduate student learning focuses on generic issues of research development. Early work, reported here, uses threshold concept theories and theories of conceptual threshold crossing to focus on the learning and supervisory support of postgraduates researching in the fields of literature and art. This paper is based on…

Work Force Education: Beyond Technical Skills. Trends and Issues Alert No. 1.

ERIC Educational Resources Information Center

Imel, Susan

This brief suggests that during the past 2 decades, the skills needed to succeed in the workplace have changed significantly. Technical skills remain important, but, increasingly, employers recognize another category of skills crucial to a worker's ability to work "smarter, not harder." These "soft,""core,""nontechnical,""essential,""generic," and…

Software and System Warranty Issues and Generic Warranty Clause.

DTIC Science & Technology

1987-06-01

communications networks and other government-furnished equipment. Special attention . must also be paid to software packages, such as operating...34 :- ’.-’".,:., ",’., . .’.’ . ’ -.’ -. ., .- . 0;/ .’.. ,; .’ ’.’...’. • . .. . * Phose A - Devekpment Test and Evaluation conducted at a test facility. * Phaie - Devopment Test and

Side-effects of generic.

PubMed

Ruzić, Klementina; Medved, Paola; Dadić-Hero, Elizabeta; Graovac, Mirjana; Tatalović-Vorkapić, Sanja; Grzeta, Ika Roncević

2010-03-01

New trends in medicine which are much more oriented towards pharmacoeconomy, are ever so common these days. There's an aim within the focus of the health system which is cutting down treatment expenses, and that relates to psychiatry practice too. Prescription drugs issued by specialist doctors are allowed to be switched with cheaper ones of the same group of drugs by GP doctors, with an aim of cost reduction. "Instead of the medicament prescribed, a GP doctor is allowed to prescribe an alternative medicament of the same efficacy in the dosage of an adequate strength" (taken from the specialist medical report form). A 74 years old man is treated for psychotic depression. Exogenic environmental factors caused the symptoms manifestation due to which hospitalization in a psychiatric ward occurred in two incidences. At the risperidone introduction soon after the second hospitalization event, a long term remission was obtained which lasted for several years. Despite a stable dose of psychopharmacs, new episode of the illness occurred. Researching the potential factors which lead towards the aggravation of the course of the illness disclosed that instead of the original risperidone, the pharmacist issued a generic in an equivalent dose.

NASA Aerospace Flight Battery Program: Generic Safety, Handling and Qualification Guidelines for Lithium-Ion (Li-Ion) Batteries; Availability of Source Materials for Lithium-Ion (Li-Ion) Batteries; Maintaining Technical Communications Related to Aerospace Batteries (NASA Aerospace Battery Workshop). Volume 1, Part 1

NASA Technical Reports Server (NTRS)

Manzo, Michelle A.; Brewer, Jeffrey C.; Bugga, Ratnakumar V.; Darcy, Eric C.; Jeevarajan, Judith A.; McKissock, Barbara I.; Schmitz, Paul C.

2010-01-01

This NASA Aerospace Flight Battery Systems Working Group was chartered within the NASA Engineering and Safety Center (NESC). The Battery Working Group was tasked to complete tasks and to propose proactive work to address battery related, agency-wide issues on an annual basis. In its first year of operation, this proactive program addressed various aspects of the validation and verification of aerospace battery systems for NASA missions. Studies were performed, issues were discussed and in many cases, test programs were executed to generate recommendations and guidelines to reduce risk associated with various aspects of implementing battery technology in the aerospace industry. This document contains Part 1 - Volume I: Generic Safety, Handling and Qualification Guidelines for Lithium-Ion (Li-Ion) Batteries, Availability of Source Materials for Lithium-Ion (Li-Ion) Batteries, and Maintaining Technical Communications Related to Aerospace Batteries (NASA Aerospace Battery Workshop).

Generic features of the wealth distribution in ideal-gas-like markets.

PubMed

Mohanty, P K

2006-07-01

We provide an exact solution to the ideal-gas-like models studied in econophysics to understand the microscopic origin of Pareto law. In these classes of models the key ingredient necessary for having a self-organized scale-free steady-state distribution is the trading or collision rule where agents or particles save a definite fraction of their wealth or energy and invest the rest for trading. Using a Gibbs ensemble approach we could obtain the exact distribution of wealth in this model. Moreover we show that in this model (a) good savers are always rich and (b) every agent poor or rich invests the same amount for trading. Nonlinear trading rules could alter the generic scenario observed here.

Challenges of therapeutic substitution of drugs for economic reasons: focus on CVD prevention.

PubMed

Johnston, Atholl

2010-04-01

Healthcare systems throughout the world are under increasing pressure to control and minimise costs. The substitution of initially-prescribed drugs with cheaper equivalents is an obvious option which presents a rapid and visible means to reduce these costs. Whether the substitution improves patient and/or population outcomes must be appraised and this paper highlights the conditions under which therapeutic substitution may require additional thought and consideration. In this paper, some of the medical evidence and the regulatory environment for and against the three types of therapeutic substitution - generic, within-class and between-class - are discussed. This article is not an exhaustive review of the literature, but captures some of the key clinical, pharmacological, economic, policy and ethical issues regarding generic and therapeutic substitution. Search criteria of the most commonly used terms, i.e. therapeutic substitution, switching, interchange, and bioequivalence, were applied to Embase, PubMed and Google Scholar to identify relevant publications. Although population studies support therapeutic substitution in principle, there is evidence that substitution may not always result in therapeutic equivalence in individual patients, with the consequent potential for greater risks of decreased efficacy and/or increased safety concerns. Factors such as patient choice and therapeutic equivalence also play an important role in the effectiveness of the treatment and overall management of the patient. The pan-European regulatory environment provides another contradiction, encouraging widespread cost containment through reduction in drug acquisition costs, while simultaneously promoting an increased role for patients in defining and managing their own treatment. There is a strong rationale for careful management in some patients with cardiovascular disease. Treatment decisions should be transparent and based on strong clinical evidence. If not, drug substitution on economic grounds alone cannot be considered to be in the individual patient's interest and is therefore unethical.

Health system challenges to integration of mental health delivery in primary care in Kenya--perspectives of primary care health workers.

PubMed

Jenkins, Rachel; Othieno, Caleb; Okeyo, Stephen; Aruwa, Julyan; Kingora, James; Jenkins, Ben

2013-09-30

Health system weaknesses in Africa are broadly well known, constraining progress on reducing the burden of both communicable and non-communicable disease (Afr Health Monitor, Special issue, 2011, 14-24), and the key challenges in leadership, governance, health workforce, medical products, vaccines and technologies, information, finance and service delivery have been well described (Int Arch Med, 2008, 1:27). This paper uses focus group methodology to explore health worker perspectives on the challenges posed to integration of mental health into primary care by generic health system weakness. Two ninety minute focus groups were conducted in Nyanza province, a poor agricultural region of Kenya, with 20 health workers drawn from a randomised controlled trial to evaluate the impact of a mental health training programme for primary care, 10 from the intervention group clinics where staff had received the training programme, and 10 health workers from the control group where staff had not received the training). These focus group discussions suggested that there are a number of generic health system weaknesses in Kenya which impact on the ability of health workers to care for clients with mental health problems and to implement new skills acquired during a mental health continuing professional development training programmes. These weaknesses include the medicine supply, health management information system, district level supervision to primary care clinics, the lack of attention to mental health in the national health sector targets, and especially its absence in district level targets, which results in the exclusion of mental health from such district level supervision as exists, and the lack of awareness in the district management team about mental health. The lack of mental health coverage included in HIV training courses experienced by the health workers was also striking, as was the intensive focus during district supervision on HIV to the detriment of other health issues. Generic health system weaknesses in Kenya impact on efforts for horizontal integration of mental health into routine primary care practice, and greatly frustrate health worker efforts.Improvement of medicine supplies, information systems, explicit inclusion of mental health in district level targets, management and supervision to primary care are likely to greatly improve primary care health worker effectiveness, and enable training programmes to be followed by better use in the field of newly acquired skills. A major lever for horizontal integration of mental health into the health system would be the inclusion of mental health in the national health sector reform strategy at community, primary care and district levels rather than just at the higher provincial and national levels, so that supportive supervision from the district level to primary care would become routine practice rather than very scarce activity. Trial registration ISRCTN 53515024.

An intelligent robot for helping astronauts

NASA Technical Reports Server (NTRS)

Erickson, J. D.; Grimm, K. A.; Pendleton, T. W.

1994-01-01

This paper describes the development status of a prototype supervised intelligent robot for space application for purposes of (1) helping the crew of a spacecraft such as the Space Station with various tasks, such as holding objects and retrieving/replacing tools and other objects from/into storage, and (2) for purposes of retrieving detached objects, such as equipment or crew, that have become separated from their spacecraft. In addition to this set of tasks in this low-Earth-orbiting spacecraft environment, it is argued that certain aspects of the technology can be viewed as generic in approach, thereby offering insight into intelligent robots for other tasks and environments. Candidate software architectures and their key technical issues which enable real work in real environments to be accomplished safely and robustly are addressed. Results of computer simulations of grasping floating objects are presented. Also described are characterization results on the usable reduced gravity environment in an aircraft flying parabola (to simulate weightlessness) and results on hardware performance there. These results show it is feasible to use that environment for evaluative testing of dexterous grasping based on real-time vision of freely rotating and translating objects.

Spacecraft fire-safety experiments for space station: Technology development mission

NASA Technical Reports Server (NTRS)

Youngblood, Wallace W.

1988-01-01

Three concept designs for low-gravity, fire-safety related experiments are presented, as selected for the purpose of addressing key issues of enhancing safety and yet encouraging access to long-duration, manned spacecraft such as the NASA space station. The selected low-gravity experiments are the following: (1) an investigation of the flame-spread rate and combustion-product evolution of the burning of typical thicknesses of spacecraft materials in very low-speed flows; (2) an evaluation of the interaction of fires and candidate extinguishers in various fire scenarios; and (3) an investigation of the persistence and propagation of smoldering and deep-seated combustion. Each experiment is expected to provide fundamental combustion-science data, as well as the fire-safety applications, and each requires the unique long-duration, low-gravity environment of the space station. Two generic test facilities, i.e., the Combustion Tunnel Facility and the Combustion Facility, are proposed for space station accommodation to support the selected experiments. In addition, three near-term, fire-safety related experiments are described along with other related precursor activities.

Physician performance assessment using a composite quality index.

PubMed

Liu, Kaibo; Jain, Shabnam; Shi, Jianjun

2013-07-10

Assessing physician performance is important for the purposes of measuring and improving quality of service and reducing healthcare delivery costs. In recent years, physician performance scorecards have been used to provide feedback on individual measures; however, one key challenge is how to develop a composite quality index that combines multiple measures for overall physician performance evaluation. A controversy arises over establishing appropriate weights to combine indicators in multiple dimensions, and cannot be easily resolved. In this study, we proposed a generic unsupervised learning approach to develop a single composite index for physician performance assessment by using non-negative principal component analysis. We developed a new algorithm named iterative quadratic programming to solve the numerical issue in the non-negative principal component analysis approach. We conducted real case studies to demonstrate the performance of the proposed method. We provided interpretations from both statistical and clinical perspectives to evaluate the developed composite ranking score in practice. In addition, we implemented the root cause assessment techniques to explain physician performance for improvement purposes. Copyright © 2012 John Wiley & Sons, Ltd.

The evolving drug development landscape: from blockbusters to niche busters in the orphan drug space.

PubMed

Kumar Kakkar, Ashish; Dahiya, Neha

2014-06-01

Strategy, Management and Health Policy Large pharmaceutical companies have traditionally focused on the development of blockbuster drugs that target disease states with large patient populations. However, with large-scale patent expirations and competition from generics and biosimilars, anemic pipelines, escalating clinical trial costs, and global health-care reform, the blockbuster model has become less viable. Orphan drug initiatives and the incentives accompanied by these have fostered renewed research efforts in the area of rare diseases and have led to the approval of more than 400 orphan products. Despite targeting much smaller patient populations, the revenue-generating potential of orphan drugs has been shown to be huge, with a greater return on investment than non-orphan drugs. The success of these "niche buster" therapeutics has led to a renewed interest from "Big Pharma" in the rare disease landscape. This article reviews the key drivers for orphan drug research and development, their profitability, and issues surrounding the emergence of large pharmaceutical firms into the orphan drug space. © 2014 Wiley Periodicals, Inc.

A Framework for Long-term Ecological Monitoring in Olympic National Park: Prototype for the Coniferous Forest Biome

USGS Publications Warehouse

Jenkins, Kurt; Woodward, Andrea; Schreiner, Ed

2003-01-01

This report is the result of a five-year collaboration between scientists of the U.S. Geological Survey Forest and Rangeland Ecosystem Science Center, Olympic Field Station, and the natural resources staff of Olympic National Park to develop a comprehensive strategy for monitoring natural resources of Olympic National Park. Olympic National Park is the National Park Serviceʼs prototype monitoring park, representing parks in the coniferous forest biome. Under the umbrella of the National Park Serviceʼs prototype parks program, U.S. Geological Survey and Olympic National Park staffs are obligated to:develop strategies and designs for monitoring the long-term health and integrity of national park ecosystems with a significant coniferous forest component.design exportable monitoring protocols that can be used by other parks within the coniferous forest biome (i.e., parks having similar environments), andcreate a demonstration area and ʻcenter of excellenceʼ for assisting other parks in developing ecological monitoring programs.Olympic National Park is part of the North Coast and Cascades Network, a network of seven Pacific Northwestern park units created recently by the National Park Serviceʼs Inventory and Monitoring Program to extend the monitoring of ʻvital signsʼ of park health to all National Park Service units. It is our intent and hope that the monitoring strategies and conceptual models described here will meet the overall purpose of the prototype parks monitoring program in proving useful not only to Olympic National Park, but also to parks within the North Coast and Cascades Network and elsewhere. Part I contains the conceptual design and sampling framework for the prototype long-term monitoring program in Olympic National Park. In this section, we explore key elements of monitoring design that help to ensure the spatial, ecological, and temporal integration of monitoring program elements and discuss approaches used to design an ecosystem-based monitoring program. Basic monitoring components include ecosystem drivers, (e.g., climate, atmospheric inputs, human pressures), indicators of ecosystem integrity (e.g., biogeochemical indicators), known threats (e.g., impacts of introduced mountain goats), and focal or ʻkeyʼ species (e.g., rare or listed species, Roosevelt elk). Monitoring system drivers and key indicators of ecosystem integrity provide the long-term baseline needed to judge what constitutes ʻunnaturalʼ variation in park resources and provide the earliest possible warning of unacceptable change. Monitoring effects of known threats and the status of focal species will provide information useful to park managers for dealing with current park issues. In Part I we describe the process of identifying potential indicators of ecological condition and present conceptual models of park ecosystems. In addition we report results from several workshops held in conjunction with Olympic National Park aimed at identifying potential indicators of change in the parkʼs ecosystem. First, we describe the responses of Olympic National Park staff to the generic question, “What is the most important resource to monitor in Olympic National Park and why?” followed by the responses from resource and land managers from areas adjoining the park. We also catalogue the responses of various expert groups that we asked to help identify the most appropriate system drivers and indicators of change in the Olympic National Park ecosystems. Results of the workshops provided the justification for selecting basic indicators of ecosystem integrity, effects of current threats to park resources, and focal resources of parks to detect both the currently evident and unforeseeable changes in park resources. We conclude Part I by exploring several generic statistical issues relevant to monitoring natural resources in Olympic National Park. Specifically we discuss trade-offs associated with sampling extensively versus sampling intensively in smaller geographic regions and describe a conceptual framework to guide development of a generic sampling frame for monitoring. We recommend partitioning Olympic National Park into three zones of decreasing accessibility to maximize monitoring efficiency. We present examples of how the generic sampling frame could be used to help ensure spatial integration of individual monitoring projects. Part II of the report is a record of the potential monitoring questions and indicators identified to date in our workshops. The presentation is organized according to the major system drivers, components, and processes identified in the intermediate-level working model of the Olympic National Park ecosystem. For each component of the park system, we develop the need and justification for monitoring, articulate park management issues, and describe key resources and ecosystem functions. We also present a pictorial conceptual model of each ecological subsystem, identify monitoring questions, and list potential indicators for each monitoring question. We conclude each section by identifying linkages of indicators to other ecological subsystems in our general ecosystem model, spatial and temporal contexts for monitoring (where and how often to monitor), and research and development needs. Part II represents the most current detailed listing of potential indicators—the material for subsequent discussions of monitoring priorities and selection of indicators for protocol development.Collectively, the sections of this report contain a comprehensive list of the important monitoring questions and potential indicators as well as recommendations for designing an integrated monitoring program. In Part I, Chapter 6 we provide recommendations on how to proceed with the important next steps in the design process: establishing priorities among the many possible monitoring questions and indicators, and beginning to research and design effective long-term monitoring protocols.

Pharmaceutical expenditure forecast model to support health policy decision making.

PubMed

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

2014-01-01

With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project 'European Union (EU) Pharmaceutical expenditure forecast' - http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). A model was built to assess policy scenarios' impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital). Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget. Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate, and distribution. Reducing, even slightly, the prices of generics had a major impact on savings. However, very aggressive pricing of generic and biosimilar products might make this market unattractive and can be counterproductive. Worth noting, delaying time to access innovative products was also identified as an effective leverage to increase savings but might not be a desirable policy for breakthrough products. Increasing patient financial contributions, either directly or indirectly via their private insurances, is a more likely scenario rather than expanding the national pharmaceutical expenditure coverage.

Pharmaceutical expenditure forecast model to support health policy decision making

PubMed Central

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

2014-01-01

Background and objective With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project ‘European Union (EU) Pharmaceutical expenditure forecast’ – http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Methods A model was built to assess policy scenarios’ impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital). Results Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget. Conclusions Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate, and distribution. Reducing, even slightly, the prices of generics had a major impact on savings. However, very aggressive pricing of generic and biosimilar products might make this market unattractive and can be counterproductive. Worth noting, delaying time to access innovative products was also identified as an effective leverage to increase savings but might not be a desirable policy for breakthrough products. Increasing patient financial contributions, either directly or indirectly via their private insurances, is a more likely scenario rather than expanding the national pharmaceutical expenditure coverage. PMID:27226830

Advanced Robotics for In-Space Vehicle Processing

NASA Technical Reports Server (NTRS)

Smith, Jeffrey H.; Estus, Jay; Heneghan, Cate; Bosley, John

1990-01-01

An analysis of spaceborne vehicle processing is described. Generic crew-EVA tasks are presented for a specific vehicle, the orbital maneuvering vehicle (OMV), with general implications to other on-orbit vehicles. The OMV is examined with respect to both servicing and maintenance. Crew-EVA activities are presented by task and mapped to a common set of generic crew-EVA primitives to identify high-demand areas for telerobot services. Similarly, a set of telerobot primitives is presented that can be used to model telerobot actions for alternative telerobot reference configurations. The telerobot primitives are tied to technologies and used for composting telerobot operations for an automated refueling scenario. Telerobotics technology issues and design accomodation guidelines (hooks and scars) for the Space Station Freedom are described.

Architecture-driven reuse of code in KASE

NASA Technical Reports Server (NTRS)

Bhansali, Sanjay

1993-01-01

In order to support the synthesis of large, complex software systems, we need to focus on issues pertaining to the architectural design of a system in addition to algorithm and data structure design. An approach that is based on abstracting the architectural design of a set of problems in the form of a generic architecture, and providing tools that can be used to instantiate the generic architecture for specific problem instances is presented. Such an approach also facilitates reuse of code between different systems belonging to the same problem class. An application of our approach on a realistic problem is described; the results of the exercise are presented; and how our approach compares to other work in this area is discussed.

Dimensional scaling for impact cratering and perforation

NASA Technical Reports Server (NTRS)

Watts, Alan J.; Atkinson, Dale

1995-01-01

POD Associates have revisited the issue of generic scaling laws able to adequately predict (within better than 20 percent) cratering in semi-infinite targets and perforations through finite thickness targets. The approach used was to apply physical logic for hydrodynamics in a consistent manner able to account for chunky-body impacts such that the only variables needed are those directly related to known material properties for both the impactor and target. The analyses were compared and verified versus CTH hydrodynamic code calculations and existing data. Comparisons with previous scaling laws were also performed to identify which (if any) were good for generic purposes. This paper is a short synopsis of the full report available through the NASA Langley Research Center, LDEF Science Office.

Generics and substitution modalities: proposed methods for the evaluation of equivalence, traceability and pharmacovigilance reporting.

PubMed

Lamarque, Véronique; Merle, Louis; Demarez, Jean Paul

2008-01-01

The use of generics results in savings for the budget of the health insurance, and no player of health could question seriously the principle. The generic drug of a reference medicinal product defines itself as a drug having the same qualitative and quantitative composition in active ingredients, the same dosage form and the bioequivalence with this reference medicinal product was demonstrated by appropriate studies of bioavailability. It is the right to switch granted to the pharmacists in 1999 that is at the origin of the real development of these specialties on the French pharmaceutical market. Nevertheless, about 10 years later, it seems that the system in place does not offer all the necessary securities with regard to pharmacovigilance, notably for the products with narrow therapeutic margin. By strengthening and/or by completing the role played by the health care professionals and the public institutions concerned, it is highly possible to improve the robustness of the system. Also, the recent arrival in Europe of the biosimilars, similar molecules but not bioequivalent to biological products, cause an even more tricky specific situation than that of the generics because of their nature, of the difficulty to manufacture them, and of the risk of immunogenicity. If the substitution is not permitted in several European countries including France, the other issues can appear especially in case of interchangeability requiring also, the reinforcement of certain measures.The various aspects are described in this article with concrete proposals on how the current system can be made safer, both for the generics and the biosimilars.

A new species of Stenasellus Dollfus, 1897 from Iran, with a key to the western Asian species (Crustacea, Isopoda, Stenasellidae).

PubMed

Khalaji-Pirbalouty, Valiallah; Fatemi, Yaser; Malek-Hosseini, Mohammad Javad; Kuntner, Matjaž

2018-01-01

A new stenasellid isopod is described from Tashan Cave, Khuzestan Province, south-west Iran, belonging to the genus Stenasellus Dollfus, 1897. The first recorded species of Stenasellidae from Iran, Stenasellus tashanicus sp. n. , is diagnosed by the presence of antennae with a minute squama bearing paired, long, robust setae; a maxilliped endite with six coupling hooks; and slender appendix masculina with an acute apex. A revised generic diagnosis is provided with a key to the six known western Asian Stenasellus species.

Typed Multiset Rewriting Specifications of Security Protocols

DTIC Science & Technology

2011-10-01

to define the type of a tuple as the sequence of the types of its components. Therefore, if A is a principal name and kA is a public key for A, the...tuple (A, kA ) would have type “principal × pubK A” (the Cartesian product symbol “×” is the standard constructor for tuple types). This construction...allows us to associate a generic principal with A’s public key: if B is another principal, then (B, kA ) will have this type as well. We will often need

Guiding Principles for Data Architecture to Support the Pathways Community HUB Model

PubMed Central

Zeigler, Bernard P.; Redding, Sarah; Leath, Brenda A.; Carter, Ernest L.; Russell, Cynthia

2016-01-01

Introduction: The Pathways Community HUB Model provides a unique strategy to effectively supplement health care services with social services needed to overcome barriers for those most at risk of poor health outcomes. Pathways are standardized measurement tools used to define and track health and social issues from identification through to a measurable completion point. The HUB use Pathways to coordinate agencies and service providers in the community to eliminate the inefficiencies and duplication that exist among them. Pathways Community HUB Model and Formalization: Experience with the Model has brought out the need for better information technology solutions to support implementation of the Pathways themselves through decision-support tools for care coordinators and other users to track activities and outcomes, and to facilitate reporting. Here we provide a basis for discussing recommendations for such a data infrastructure by developing a conceptual model that formalizes the Pathway concept underlying current implementations. Requirements for Data Architecture to Support the Pathways Community HUB Model: The main contribution is a set of core recommendations as a framework for developing and implementing a data architecture to support implementation of the Pathways Community HUB Model. The objective is to present a tool for communities interested in adopting the Model to learn from and to adapt in their own development and implementation efforts. Problems with Quality of Data Extracted from the CHAP Database: Experience with the Community Health Access Project (CHAP) data base system (the core implementation of the Model) has identified several issues and remedies that have been developed to address these issues. Based on analysis of issues and remedies, we present several key features for a data architecture meeting the just mentioned recommendations. Implementation of Features: Presentation of features is followed by a practical guide to their implementation allowing an organization to consider either tailoring off-the-shelf generic systems to meet the requirements or offerings that are specialized for community-based care coordination. Discussion: Looking to future extensions, we discuss the utility and prospects for an ontology to include care coordination in the Unified Medical Language System (UMLS) of the National Library of Medicine and other existing medical and nursing taxonomies. Conclusions and Recommendations: Pathways structures are an important principle, not only for organizing the care coordination activities, but also for structuring the data stored in electronic form in the conduct of such care. We showed how the proposed architecture encourages design of effective decision support systems for coordinated care and suggested how interested organizations can set about acquiring such systems. Although the presentation focuses on the Pathways Community HUB Model, the principles for data architecture are stated in generic form and are applicable to any health information system for improving care coordination services and population health. PMID:26870743

Empirically supported religious and spiritual therapies.

PubMed

Hook, Joshua N; Worthington, Everett L; Davis, Don E; Jennings, David J; Gartner, Aubrey L; Hook, Jan P

2010-01-01

This article evaluated the efficacy status of religious and spiritual (R/S) therapies for mental health problems, including treatments for depression, anxiety, unforgiveness, eating disorders, schizophrenia, alcoholism, anger, and marital issues. Religions represented included Christianity, Islam, Taoism, and Buddhism. Some studies incorporated a generic spirituality. Several R/S therapies were found to be helpful for clients, supporting the further use and research on these therapies. There was limited evidence that R/S therapies outperformed established secular therapies, thus the decision to use an R/S therapy may be an issue of client preference and therapist comfort.

Tank 241-C-112 vapor sampling and analysis tank characterization report. Revision 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huckaby, J.L.

1995-05-31

Tank 241-C-112 headspace gas and vapor samples were collected and analyzed to help determine the potential risks to tank farm workers due to fugitive emissions from the tank. The drivers and objectives of waste tank headspace sampling and analysis are discussed in {open_quotes}Program Plan for the Resolution of Tank Vapor Issues.{close_quotes} Tank 241-C-112 was vapor sampled in accordance with {open_quotes}Data Quality Objectives for Generic In-Tank Health and Safety Issue Resolution.{close_quotes}

Product qualification: a barrier to point-of-care microfluidic-based diagnostics?

PubMed

Tantra, Ratna; van Heeren, Henne

2013-06-21

One of the most exciting applications of microfluidics-based diagnostics is its potential use in next generation point-of-care (POC) devices. Many prototypes are already in existence, but, as of yet, few have achieved commercialisation. In this article, we consider the issue surrounding product qualification as a potential barrier to market success. The study discusses, in the context of POC microfluidics-based diagnostics, what the generic issues are and potential solutions. Our findings underline the need for a community-based effort that is necessary to speed up the product qualification process.

Evolution of the Generic Lock System at Jefferson Lab

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brian Bevins; Yves Roblin

2003-10-13

The Generic Lock system is a software framework that allows highly flexible feedback control of large distributed systems. It allows system operators to implement new feedback loops between arbitrary process variables quickly and with no disturbance to the underlying control system. Several different types of feedback loops are provided and more are being added. This paper describes the further evolution of the system since it was first presented at ICALEPCS 2001 and reports on two years of successful use in accelerator operations. The framework has been enhanced in several key ways. Multiple-input, multiple-output (MIMO) lock types have been added formore » accelerator orbit and energy stabilization. The general purpose Proportional-Integral-Derivative (PID) locks can now be tuned automatically. The generic lock server now makes use of the Proxy IOC (PIOC) developed at Jefferson Lab to allow the locks to be monitored from any EPICS Channel Access aware client. (Previously clients had to be Cdev aware.) The dependency on the Qt XML parser has been replaced with the freely available Xerces DOM parser from the Apache project.« less

Stakeholder participation in health impact assessment: A multicultural approach

DOE Office of Scientific and Technical Information (OSTI.GOV)

Negev, Maya, E-mail: mayane@tau.ac.il; Davidovitch, Nadav, E-mail: nadavd@bgu.ac.il; Garb, Yaakov, E-mail: ygarb@bgu.ac.il

2013-11-15

The literature on impact assessment (HIA) registers the importance of stakeholder participation in the assessment process, but still lacks a model for engaging stakeholders of diverse ethnic, professional and sectorial backgrounds. This paper suggests that the multicultural approach can contribute to HIA through a revision of the generic 5-step HIA model, and its implementation in a metropolitan plan in Southern Israel. The health issue scoped by the stakeholders in the HIA is related to land uses in the vicinity of the national hazardous industry and hazardous waste site. The stakeholders were representatives of the diverse populations at stake, including ruralmore » Bedouins and Jewish city dwellers, as well as representatives from the public sector, private sector, non-governmental organizations and academia. The case study revealed that a multicultural stakeholder participation process helps to uncover health issues known to the community which were not addressed in the original plan, and provides local knowledge regarding health conditions that is especially valuable when scientific data is uncertain or absent. It enables diverse stakeholders to prioritize the health issues that will be assessed. The case study also reveals ways in which the model needs revisions and improvements such as in recruitment of diverse participants. This paper presents a multicultural model of HIA and discusses some of the challenges that are faced when HIA is implemented in the context of current decision-making culture. -- Highlights: • We revised the generic HIA model in light of the multicultural approach. • We tested the model in a case study of zoning a hazardous industry site. • Multicultural stakeholder participation uncovers health issues known to communities. • It enables community prioritization of health issues. • We present a model for multicultural stakeholder participation in HIA.« less

Conceptual design of the National Ignition Facility

NASA Astrophysics Data System (ADS)

Paisner, Jeffrey A.; Boyes, John D.; Kumpan, Steven A.; Lowdermilk, W. Howard; Sorem, Michael S.

1995-12-01

The Secretary of the U.S. Department of Energy (DOE) commissioned a conceptual design report (CDR) for the National Ignition Facility (NIF) in January 1993 as part of a key decision zero (KD0), justification of mission need. Motivated by the progress to date by the inertial confinement fusion (ICF) program in meeting the Nova technical contract goals established by the National Academy of Sciences in 1989, the Secretary requested a design using a solid-state laser driver operating at the third harmonic (0.35 micrometer) of neodymium (Nd) glass. The participating ICF laboratories signed a memorandum of agreement in August 1993, and established a project organization, including a technical team from the Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Sandia National Laboratories (SNL), and the Laboratory for Laser Energetics at the University of Rochester. Since then, we completed the NIF conceptual design, based on standard construction at a generic DOE defense program's site, and issued a 7,000-page, 27-volume CDR in May 1994. Over the course of the conceptual design study, several other key documents were generated, including a facilities requirements document, a conceptual design scope and plan, a target physics design document, a laser design cost basis document, a functional requirements document, an experimental plan for indirect drive ignition, and a preliminary hazards analysis (PHA) document. DOE used the PHA to categorize the NIF as a low-hazard, non-nuclear facility. On October 21, 1994 the Secretary of Energy issued a key decision one (KD1) for the NIF, which approved the project and authorized DOE to request Office of Management and Budget-approval for congressional line-item FY 1996 NIF funding for preliminary engineering design and for National Environmental Policy Act activities. In addition, the Secretary declared Livermore as the preferred site for constructing the NIF. In February 1995, the NIF Project was formally submitted to Congress as part of the President's FY 1996 budget. If funded as planned, the Project will cost approximately $1.1 billion and will be completed at the end of FY 2002.

GeoSegmenter: A statistically learned Chinese word segmenter for the geoscience domain

NASA Astrophysics Data System (ADS)

Huang, Lan; Du, Youfu; Chen, Gongyang

2015-03-01

Unlike English, the Chinese language has no space between words. Segmenting texts into words, known as the Chinese word segmentation (CWS) problem, thus becomes a fundamental issue for processing Chinese documents and the first step in many text mining applications, including information retrieval, machine translation and knowledge acquisition. However, for the geoscience subject domain, the CWS problem remains unsolved. Although a generic segmenter can be applied to process geoscience documents, they lack the domain specific knowledge and consequently their segmentation accuracy drops dramatically. This motivated us to develop a segmenter specifically for the geoscience subject domain: the GeoSegmenter. We first proposed a generic two-step framework for domain specific CWS. Following this framework, we built GeoSegmenter using conditional random fields, a principled statistical framework for sequence learning. Specifically, GeoSegmenter first identifies general terms by using a generic baseline segmenter. Then it recognises geoscience terms by learning and applying a model that can transform the initial segmentation into the goal segmentation. Empirical experimental results on geoscience documents and benchmark datasets showed that GeoSegmenter could effectively recognise both geoscience terms and general terms.

Two-Dimensional Work: Workplace Literacy in the Aged Care and Call Centre Industries

ERIC Educational Resources Information Center

Waterhouse, Peter; Virgona, Crina

2004-01-01

A key challenge of Australia's vocational education and training (VET) system is to serve the broad needs of individuals, communities, and industries. This includes the provision of literacy and generic skills which meet the needs of all groups. This study investigates and documents workplace literacy in aged care facilities and call centres,…

Learning Analytics and Educational Data Mining in Practice: A Systematic Literature Review of Empirical Evidence

ERIC Educational Resources Information Center

Papamitsiou, Zacharoula; Economides, Anastasios A.

2014-01-01

This paper aims to provide the reader with a comprehensive background for understanding current knowledge on Learning Analytics (LA) and Educational Data Mining (EDM) and its impact on adaptive learning. It constitutes an overview of empirical evidence behind key objectives of the potential adoption of LA/EDM in generic educational strategic…

A Corpus-Based View of Lexical Gender in Written Business English

ERIC Educational Resources Information Center

Fuertes-Olivera, Pedro A.

2007-01-01

This article investigates lexical gender in specialized communication. The key method of analysis is that of forms of address, professional titles, and "generic man" in a 10 million word corpus of written Business English. After a brief introduction and literature review on both gender in specialized communication and similar corpus-based views of…

Elucidations on the Reciprocal Lattice and the Ewald Sphere

ERIC Educational Resources Information Center

Foadi, J.; Evans, G.

2008-01-01

The reciprocal lattice is derived through the Fourier transform of a generic crystal lattice, as done previously in the literature. A few key derivations are this time handled in detail, and the connection with x-ray diffraction is clearly pointed out. The Ewald sphere is subsequently thoroughly explained and a few comments on its representation…

Life prediction systems for critical rotating components

NASA Technical Reports Server (NTRS)

Cunningham, Susan E.

1993-01-01

With the advent of advanced materials in rotating gas turbine engine components, the methodologies for life prediction of these parts must also increase in sophistication and capability. Pratt & Whitney's view of generic requirements for composite component life prediction systems are presented, efforts underway to develop these systems are discussed, and industry participation in key areas requiring development is solicited.

A Systematic Review of Developing Team Competencies in Information Systems Education

ERIC Educational Resources Information Center

Figl, Kathrin

2010-01-01

The ability to work effectively in teams has been a key competence for information systems engineers for a long time. Gradually, more attention is being paid to developing this generic competence as part of academic curricula, resulting in two questions: how to best promote team competencies and how to implement team projects successfully. These…

Strategies for teaching object-oriented concepts with Java

NASA Astrophysics Data System (ADS)

Sicilia, Miguel-Ángel

2006-03-01

A considerable amount of experiences in teaching object-oriented concepts using the Java language have been reported to date, some of which describe language pitfalls and concrete learning difficulties. In this paper, a number of additional issues that have been experienced as difficult for students to master, along with approaches intended to overcome them, are addressed. Concretely, practical issues regarding associations, interfaces, genericity and exceptions are described. These issues suggest that more emphasis is required on presenting Java programs as derivations of conceptual models, in order to guarantee that a thorough design of the object structure actually precedes implementation issues. In addition, common student misunderstandings about the uses of interfaces and exceptions point to the necessity of introducing both specific design philosophies and also a clear distinction between design-for-reuse and more specific implementation issues.

Reconstruction of genome-scale human metabolic models using omics data.

PubMed

Ryu, Jae Yong; Kim, Hyun Uk; Lee, Sang Yup

2015-08-01

The impact of genome-scale human metabolic models on human systems biology and medical sciences is becoming greater, thanks to increasing volumes of model building platforms and publicly available omics data. The genome-scale human metabolic models started with Recon 1 in 2007, and have since been used to describe metabolic phenotypes of healthy and diseased human tissues and cells, and to predict therapeutic targets. Here we review recent trends in genome-scale human metabolic modeling, including various generic and tissue/cell type-specific human metabolic models developed to date, and methods, databases and platforms used to construct them. For generic human metabolic models, we pay attention to Recon 2 and HMR 2.0 with emphasis on data sources used to construct them. Draft and high-quality tissue/cell type-specific human metabolic models have been generated using these generic human metabolic models. Integration of tissue/cell type-specific omics data with the generic human metabolic models is the key step, and we discuss omics data and their integration methods to achieve this task. The initial version of the tissue/cell type-specific human metabolic models can further be computationally refined through gap filling, reaction directionality assignment and the subcellular localization of metabolic reactions. We review relevant tools for this model refinement procedure as well. Finally, we suggest the direction of further studies on reconstructing an improved human metabolic model.

Comparison of Standard Wind Turbine Models with Vendor Models for Power System Stability Analysis: Preprint

DOE Office of Scientific and Technical Information (OSTI.GOV)

Honrubia-Escribano, A.; Gomez Lazaro, E.; Jimenez-Buendia, F.

The International Electrotechnical Commission Standard 61400-27-1 was published in February 2015. This standard deals with the development of generic terms and parameters to specify the electrical characteristics of wind turbines. Generic models of very complex technological systems, such as wind turbines, are thus defined based on the four common configurations available in the market. Due to its recent publication, the comparison of the response of generic models with specific vendor models plays a key role in ensuring the widespread use of this standard. This paper compares the response of a specific Gamesa dynamic wind turbine model to the corresponding genericmore » IEC Type III wind turbine model response when the wind turbine is subjected to a three-phase voltage dip. This Type III model represents the doubly-fed induction generator wind turbine, which is not only one of the most commonly sold and installed technologies in the current market but also a complex variable-speed operation implementation. In fact, active and reactive power transients are observed due to the voltage reduction. Special attention is given to the reactive power injection provided by the wind turbine models because it is a requirement of current grid codes. Further, the boundaries of the generic models associated with transient events that cannot be represented exactly are included in the paper.« less

Key Technical Aspects Influencing the Accuracy of Tablet Subdivision.

PubMed

Teixeira, Maíra T; Sá-Barreto, Lívia C L; Gratieri, Taís; Gelfuso, Guilherme M; Silva, Izabel C R; Cunha-Filho, Marcílio S S

2017-05-01

Tablet subdivision is a common practice used mainly for dose adjustment. The aim of this study was to investigate how the technical aspects of production as well as the method of tablets subdivision (employing a tablet splitter or a kitchen knife) influence the accuracy of this practice. Five drugs commonly used as subdivided tablets were selected. For each drug, the innovator drug product, a scored-generic and a non-scored generic were investigated totalizing fifteen drug products. Mechanical and physical tests, including image analysis, were performed. Additionally, comparisons were made between tablet subdivision method, score, shape, diluent composition and coating. Image analysis based on surface area was a useful tool as an alternative assay to evaluate the accuracy of tablet subdivision. The tablet splitter demonstrates an advantage relative to a knife as it showed better results in weight loss and friability tests. Oblong, coated and scored tablets had better results after subdivision than round, uncoated and non-scored tablets. The presence of elastic diluents such as starch and dibasic phosphate dehydrate conferred a more appropriate behaviour for the subdivision process than plastic materials such as microcrystalline cellulose and lactose. Finally, differences were observed between generics and their innovator products in all selected drugs with regard the quality control assays in divided tablet, which highlights the necessity of health regulations to consider subdivision performance at least in marketing authorization of generic products.

Coast Guard Cutter Procurement: Background and Issues for Congress

DTIC Science & Technology

2015-07-28

Research Service Summary The Coast Guard’s program of record (POR) calls for procuring 8 National Security Cutters (NSCs), 25 Offshore Patrol Cutters...3 Figure 2. Offshore Patrol Cutter (Generic Conceptual... Offshore Patrol Cutters (OPCs), and 58 Fast Response Cutters (FRCs). These 91 planned cutters are intended as replacements for 90 aging Coast Guard cutters

Diagnostic, Predictive and Compositional Modeling with Data Mining in Integrated Learning Environments

ERIC Educational Resources Information Center

Lee, Chien-Sing

2007-01-01

Models represent a set of generic patterns to test hypotheses. This paper presents the CogMoLab student model in the context of an integrated learning environment. Three aspects are discussed: diagnostic and predictive modeling with respect to the issues of credit assignment and scalability and compositional modeling of the student profile in the…

Developing Professionalism in the Child Care Industry. An Instructional Program Guide for Child Care Workers.

ERIC Educational Resources Information Center

Johnson, Ann; And Others

This program guide documents a child care job family curriculum that develops competence in generic work force education skills through two minicourses: Basic Issues in Child Care and Child Development Associate. An annotated table of contents lists a brief description of the questions answered in each section. An introduction presents a program…

76 FR 2924 - Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX; Adequacy of Station...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... positions. No specific action or written response is required. DATES: Comment period expires 30 days after... new requirements or staff positions. No specific action or written response is required. Background... on the operation of Class 1E loads. These degraded voltage conditions will not be detected by the...

Current Issues in Self-Regulation Research and Their Significance for Therapeutic Intervention in Offender Groups

ERIC Educational Resources Information Center

Ross, Thomas

2008-01-01

During the last decade, theory and research on human self-regulation has made significant progress. While self-regulation may be understood as a generic term comprising a range of different cognitive, emotional, and behavioral processes, most research pertains to a subcomponent of self-regulation, namely emotional self-regulation, or emotional…

Space transfer concepts and analysis for exploration missions

NASA Technical Reports Server (NTRS)

1991-01-01

Covered here is the second phase of a broad scoped and systematic study of space transfer concepts for human lunar and Mars missions. The study addressed issues that were raised during Phase 1, developed generic Mars missions profile analysis data, and conducted preliminary analysis of the Mars in-space transportation requirements and implementation from the Stafford Committee Synthesis Report.

75 FR 54384 - Notice of Intent To Prepare an Environmental Impact Statement for the Gas Hills Uranium Project...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

..., the reader is referred to the Nuclear Regulatory Commission's Generic EIS of In-Situ Leach Uranium.... SUMMARY: Pursuant to the National Environmental Policy Act of 1969, as amended, (NEPA) and in response to... to solicit public comments regarding issues and resource information for the proposed Gas Hills in...

Generic screen representations for future-proof systems, is it possible? There is more to a GUI than meets the eye.

PubMed

van der Linden, Helma; Austin, Tony; Talmon, Jan

2009-09-01

Future-proof EHR systems must be capable of interpreting information structures for medical concepts that were not available at the build-time of the system. The two-model approach of CEN 13606/openEHR using archetypes achieves this by separating generic clinical knowledge from domain-related knowledge. The presentation of this information can either itself be generic, or require design time awareness of the domain knowledge being employed. To develop a Graphical User Interface (GUI) that would be capable of displaying previously unencountered clinical data structures in a meaningful way. Through "reasoning by analogy" we defined an approach for the representation and implementation of "presentational knowledge". A proof-of-concept implementation was built to validate its implementability and to test for unanticipated issues. A two-model approach to specifying and generating a screen representation for archetype-based information, inspired by the two-model approach of archetypes, was developed. There is a separation between software-related display knowledge and domain-related display knowledge and the toolkit is designed with the reuse of components in mind. The approach leads to a flexible GUI that can adapt not only to information structures that had not been predefined within the receiving system, but also to novel ways of displaying the information. We also found that, ideally, the openEHR Archetype Definition Language should receive minor adjustments to allow for generic binding.

Canada's Patented Medicine Notice of Compliance regulations: balancing the scales or tipping them?

PubMed Central

2011-01-01

Background In order to comply with the provisions of the North American Free Trade Agreement, in 1993 the Canadian federal government introduced the Patented Medicine Notice of Compliance Linkage Regulations. These regulations were meant to achieve a balance between the timely entry of generic medicines and the rights of patent holders. The regulations tied the regulatory approval of generic medicines to the patent status of the original brand-name product. Discussion Since their introduction the regulations have been a source of contention between the generic and the brand-name industry. While the regulations have generated a considerable amount of work for the Federal Court of Canada both sides dispute the interpretation of the "win rate" in the court cases. Similarly, there is no agreement on whether multiple patents on single drugs represent a legitimate activity by the brand-name industry or an "evergreening" tactic. The generic industry's position is that the regulations are being abused leading to the delay in the introduction of lower cost generic products by as much as 8 years. The brand-name companies counter that the regulations are necessary because injunctions against the introduction of generic products are frequently unavailable to them. The regulations were amended in 2006 and again in 2008 but both sides continue to claim that the regulations favour the other party. The battle around the regulations also has an international dimension with interventions by PhRMA, the trade association representing the United States based multinational companies, arguing that the regulations are not stringent enough and that Canada needs to be placed on the U.S. Priority Watch List of countries. Finally, there are multiple costs to Canadian society as a result of the NOC regulations. Summary Despite the rhetoric there has been almost no empiric academic research done into the effect of the regulations. In order to develop rational policy in this area a number of key research questions have been formulated. PMID:21435247

Freedom of information applications as an "evergreening" tactic: Secretary, Department of Health and Ageing v iNOVA Pharmaceuticals (Australia) Pty Ltd (2010) 191 FCR 573; [2010] FCA 1442.

PubMed

Vines, Tim; Faunce, Thomas

2011-09-01

A recent decision of the Federal Court of Australia illustrates how patent-holding pharmaceutical companies are attempting to use Australia's Freedom of Information Act 1982 (Cth) to force Australian safety, quality and efficacy regulators to disclose whether generic competitors are attempting to enter the market. In Secretary, Department of Health and Ageing v iNova Pharmaceuticals (Australia) Pty Ltd (2010) 191 FCR 573; [2010] FCA 1442 a single judge of the Federal Court overturned a decision of the Administrative Appeals Tribunal (AAT) that would have compelled the Australian Therapeutic Goods Administration (TGA) to reveal whether they were in possession of an application to register generic versions of two iNova products: imiquimod and phentermine. In its justification to the AAT for refusing to confirm or deny the existence of any application, the TGA argued that to reveal the existence of such a document would prejudice the proper administration of the National Health Act 1953 (Cth) as it could compromise the listing of a generic on the Pharmaceutical Benefits Scheme. The AAT failed to appreciate the extent to which this revelation to a competitor would have undercut 2004 amendments to the Therapeutic Goods Act 1989 (Cth) that provided penalties for evergreening tactics involving TGA notifications to drug patent-holders and 2006 amendments to the Patents Act 1990 (Cth) which protected the right of generic manufacturers to "springboard". The decision of the Federal Court is one of the first to explore the use of freedom of information legislation by patent-holders as a potential "evergreening" technique to prolong royalties by marginalising generic competition. Because of the significant amounts of money involved in ensuring rapid market entry of low-cost generic products, the issue has considerable public health significance.

Evaluating Drug Prices, Availability, Affordability, and Price Components: Implications for Access to Drugs in Malaysia

PubMed Central

Babar, Zaheer Ud Din; Ibrahim, Mohamed Izham Mohamed; Singh, Harpal; Bukahri, Nadeem Irfan; Creese, Andrew

2007-01-01

Background Malaysia's stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components. Methods and Findings The methodology developed by the World Health Organization (WHO) and Health Action International (HAI) was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs) to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB) prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%–76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high—25%–38% and 100%–140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a month's treatment for peptic ulcer disease and hypertension people have to pay about a week's wages in the private sector. Conclusions The free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and affordability, promotion of generic medicines and improved availability of medicines in the public sector are required. PMID:17388660

Evaluating drug prices, availability, affordability, and price components: implications for access to drugs in Malaysia.

PubMed

Babar, Zaheer Ud Din; Ibrahim, Mohamed Izham Mohamed; Singh, Harpal; Bukahri, Nadeem Irfan; Creese, Andrew

2007-03-27

Malaysia's stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components. The methodology developed by the World Health Organization (WHO) and Health Action International (HAI) was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs) to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB) prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%-76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high-25%-38% and 100%-140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a month's treatment for peptic ulcer disease and hypertension people have to pay about a week's wages in the private sector. The free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and affordability, promotion of generic medicines and improved availability of medicines in the public sector are required.

Notes on Phalangiidae (Arachnida: Opiliones) of southern Africa with description of new species and comments on within-species variation.

PubMed

Taylor, Christopher K

2017-05-29

Notes are provided on a collection of Afrotropical harvestmen (Opiliones: Palpatores: Phalangiidae) from the California Academy of Sciences. A new species of Rhampsinitus, R. conjunctidens n. sp., is described from Limpopo province of South Africa. Rhampsinitus flavobrunneus Staręga 2009 and R. silvaticus Lawrence 1931 are recognised as junior synonyms of R. nubicolus Lawrence 1963 and R. vittatus Lawrence 1931, respectively. Both R. conjunctidens and R. nubicolus are recognised as exhibiting strong male dimorphism with major males exhibiting larger body size and greatly enlarged chelicerae relative to minor males; minor males cannot be readily identified to species without examination of genitalia. A discussion is also provided on generic boundaries within Afrotropical Phalangiidae, and a generic key to males of the region is presented.

G STL: the geostatistical template library in C++

NASA Astrophysics Data System (ADS)

Remy, Nicolas; Shtuka, Arben; Levy, Bruno; Caers, Jef

2002-10-01

The development of geostatistics has been mostly accomplished by application-oriented engineers in the past 20 years. The focus on concrete applications gave birth to many algorithms and computer programs designed to address different issues, such as estimating or simulating a variable while possibly accounting for secondary information such as seismic data, or integrating geological and geometrical data. At the core of any geostatistical data integration methodology is a well-designed algorithm. Yet, despite their obvious differences, all these algorithms share many commonalities on which to build a geostatistics programming library, lest the resulting library is poorly reusable and difficult to expand. Building on this observation, we design a comprehensive, yet flexible and easily reusable library of geostatistics algorithms in C++. The recent advent of the generic programming paradigm allows us elegantly to express the commonalities of the geostatistical algorithms into computer code. Generic programming, also referred to as "programming with concepts", provides a high level of abstraction without loss of efficiency. This last point is a major gain over object-oriented programming which often trades efficiency for abstraction. It is not enough for a numerical library to be reusable, it also has to be fast. Because generic programming is "programming with concepts", the essential step in the library design is the careful identification and thorough definition of these concepts shared by most geostatistical algorithms. Building on these definitions, a generic and expandable code can be developed. To show the advantages of such a generic library, we use G STL to build two sequential simulation programs working on two different types of grids—a surface with faults and an unstructured grid—without requiring any change to the G STL code.

Review of the leafhopper genus Alnetoidia Dlabola (Hemiptera: Cicadellidae: Typhlocybinae: Erythroneurini) from China, with descriptions of  two new species.

PubMed

Cao, Yanghui; Yang, Meixia; Zhang, Yalin

2016-11-17

Generic characteristics of genus Alnetoidia Dlabola are revised based on study of nine species from China, including two new species: A. (Alnetoidia) gracilis, A. (Alnella) dentata spp. nov., and four new records to China. A key to species for identification of Chinese adult males is provided.

A new species of Glochinomyia Kertész from Papua New Guinea (Diptera: Stratiomyidae, Pachygastrinae).

PubMed

Rozkošný, Rudolf

2013-01-01

Glochinomyia nigriseta sp. nov. is described and illustrated. The generic characters of Glochinomyia are summarized and the new species is compared with the description of the only known species, G albiseta Kertész. The taxonomic position of Glochinomyia is briefly discussed and the Papuan species of the Pachygastrinae with four scutellar spines are keyed.

Taking the Sociological Imagination to School: An Analysis of the (Lack of) Impact of Information and Communication Technologies on Education Systems

ERIC Educational Resources Information Center

Somekh, Bridget

2004-01-01

This article suggests that it is time for sociologists to redirect their focus from critiques of policy makers' unrealistic visions for information and communication technologies (ICTs) to the more generic issues that consistently mobilise resistance to ICTs within schools and education systems. There is an extraordinary difference between young…

76 FR 10072 - Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX, Adequacy of Station...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-23

... electronic form will be posted on the NRC Web site and on the Federal Rulemaking Web site Regulations.gov... that they do not want publicly disclosed. Federal rulemaking Web site: Go to http://www.regulations.gov... through this Web site. Address questions about NRC dockets to Carol Gallagher, telephone: 301-492-3668, e...

Shifting the Balance in First-Year Learning Support: From Staff Instruction to Peer-Learning Primacy

ERIC Educational Resources Information Center

van der Meer, Jacques; Scott, Carole

2008-01-01

Effective response to the learning needs of first-year students is a contested issue. In many learning support centres the dominant approach to developing student learning skills is through generic or tailored workshops and/or individual consultations. Although there is a place for these activities, we argue that the balance should be shifted…

Topical Trends in a Corpus of Persuasive Writing. Research Report. ETS RR-12-19

ERIC Educational Resources Information Center

Heilman, Michael; Madnani, Nitin

2012-01-01

Many writing assessments use generic prompts about social issues. However, we currently lack an understanding of how test takers respond to such prompts. In the absence of such an understanding, automated scoring systems may not be as reliable as they could be and may worsen over time. To move toward a deeper understanding of responses to generic…

Fusing Horizons -- A Grammatical Design Approach for the Arts and Humanities: Using Rules, Contingency and Hermeneutics in Design Education

ERIC Educational Resources Information Center

Bruton, Dean

2007-01-01

This article argues that grammatical thinking within a framework of phenomenological hermeneutics assists designing and may properly be used as a fundamental teaching approach for an interdisciplinary art and design studio. Furthermore, it argues that the theme of grammatical design awareness could be considered as a generic issue across all…

Students' and Teachers' Perceptions of Creativity, Communication and Problem-Solving in the School Curriculum: Hong Kong Perspective

ERIC Educational Resources Information Center

Lee, John Chi-Kin; Chan, Nim Chi; Xu, Huixuan; Chun, Derek Wai-sun

2017-01-01

The development of generic skills is a focal issue in education policy and school curriculum reform across countries. This study in the Hong Kong context explores the sources of formal and non-formal curriculum and learning activities related to senior secondary students' perceptions of learning outcomes in creativity, communication, and problem…

Coast Guard Cutter Procurement: Background and Issues for Congress

DTIC Science & Technology

2016-04-04

and 58 Fast Response Cutters (FRCs) as replacements for 90 aging Coast Guard cutters and patrol craft. The Coast Guard’s proposed FY2017 budget...Offshore Patrol Cutter (Generic Conceptual Rendering) ................................................. 5 Figure 3. Fast Response Cutter...National Security Cutters (NSCs), 25 Offshore Patrol Cutters (OPCs), and 58 Fast Response Cutters (FRCs). These 91 planned cutters are intended as

How could (should) we make contact between string/M-theory and our four-dimensional world, and associated LHC predictions?

NASA Astrophysics Data System (ADS)

Kane, Gordon

2015-12-01

String/M-theory is an exciting framework within which we try to understand our universe and its properties. Compactified string/M-theories address and offer solutions to almost every important question and issue in particle physics and particle cosmology. But earlier goals of finding a top-down “vacuum selection” principle and deriving the 4D theory have not yet been realized. Does that mean we should stop trying, as nearly all string theorists have? Or can we proceed in the historical way to make a few generic, robust assumptions not closely related to observables, and follow where they lead to testable predictions and explanations? Making only very generic assumptions is a significant issue. I discuss how to try to proceed with this approach, particularly in M-theory compactified on a 7D manifold of G2 holonomy. One goal is to understand our universe as a string/M-theory vacuum for its own sake, in the long tradition of trying to understand our world, and what that implies. In addition, understanding our vacuum may be a prelude to understanding its connection to the multiverse.

Development of pressure containment and damage tolerance technology for composite fuselage structures in large transport aircraft

NASA Technical Reports Server (NTRS)

Smith, P. J.; Thomson, L. W.; Wilson, R. D.

1986-01-01

NASA sponsored composites research and development programs were set in place to develop the critical engineering technologies in large transport aircraft structures. This NASA-Boeing program focused on the critical issues of damage tolerance and pressure containment generic to the fuselage structure of large pressurized aircraft. Skin-stringer and honeycomb sandwich composite fuselage shell designs were evaluated to resolve these issues. Analyses were developed to model the structural response of the fuselage shell designs, and a development test program evaluated the selected design configurations to appropriate load conditions.

An ideal hospital.

PubMed

Chandrasiri, Singithi Sidney

2017-07-03

Purpose The purpose of this paper is to explore a novel overarching strategy in tackling the key issues raised by the recent inquiry into bullying, harassment and discrimination in surgical practice and surgical training in Australian and New Zealand hospitals. Design/methodology/approach The approach taken is an analysis of the available evidence-based literature to inform the proposed viewpoint. The theoretical subject scope presented is a discussion of how and why the various strategies put forward in this paper should be integrated into and led from an overarching workforce engagement platform. Findings The key themes isolated from the Inquiry into Australian and New Zealand surgical practice ranged from abuse of power by those in leadership positions, gender inequity in the surgical workforce, opaque and corrupt complaints handling processes, excessive surgical trainee working hours to bystander silence secondary to a fear of reprisal. A workforce engagement perspective has elicited the potential to counter various impacts, that of clinical ineffectiveness, substandard quality and safety, inefficient medical workforce management outcomes, adverse economic implications and the operational profitability of a hospital. Generic strategies grounded in evidence-based literature were able to then be aligned with specific action areas to provide a new leadership framework for addressing these impacts. Originality/value To the author's knowledge, this is one of the first responses providing a framework on how medical managers and hospital executives can begin to lead a comprehensive and practical strategy for changing the existing culture of bullying, harassment and discrimination in surgical practice by using a staff engagement framework.

Qualitative exploration of the career aspirations of rural origin health science students in South Africa.

PubMed

Diab, Paula N; Flack, Penny S; Mabuza, Langalibalele H; Reid, Stephen J Y

2012-01-01

There is evidence in the literature that rural background significantly encourages eventual rural practice. Given the shortage of healthcare providers in rural areas, we need to explore ways of ensuring throughput and success of rural-origin students in health sciences. It is therefore important to understand who these students are, what motivates them and the factors involved in the formation of their career choices. The aim of this study is to understand the aspirations of undergraduate health science students of rural origin with regard to their future career plans. The objectives of the study include to explore and identify the key issues facing rural-origin students with regard to their future career plans. Individual interviews were conducted with 15 health science students from two South African universities. Transcriptions were analyzed with the aid of Nvivo v8 (www.qsrinternational.com). The findings suggest health science students of rural origin studying at universities in the South African context face specific challenges related to the nature of the contrast between rural and urban life, in addition to the more generic adaptations that confront all students on entering tertiary education. In order to support rural students in their studies, academic, financial, emotional and social stressors need to be addressed. Universities should strengthen existing support structures as well as aid the development of further support that may be required.Key words: career plan, health science, rural background, South Africa.

Technical issues affecting the implementation of US Environmental Protection Agency's proposed fish tissue-based aquatic criterion for selenium.

PubMed

Lemly, A Dennis; Skorupa, Joseph P

2007-10-01

The US Environmental Protection Agency is developing a national water quality criterion for selenium that is based on concentrations of the element in fish tissue. Although this approach offers advantages over the current water-based regulations, it also presents new challenges with respect to implementation. A comprehensive protocol that answers the "what, where, and when" is essential with the new tissue-based approach in order to ensure proper acquisition of data that apply to the criterion. Dischargers will need to understand selenium transport, cycling, and bioaccumulation in order to effectively monitor for the criterion and, if necessary, develop site-specific standards. This paper discusses 11 key issues that affect the implementation of a tissue-based criterion, ranging from the selection of fish species to the importance of hydrological units in the sampling design. It also outlines a strategy that incorporates both water column and tissue-based approaches. A national generic safety-net water criterion could be combined with a fish tissue-based criterion for site-specific implementation. For the majority of waters nationwide, National Pollution Discharge Elimination System permitting and other activities associated with the Clean Water Act could continue without the increased expense of sampling and interpreting biological materials. Dischargers would do biotic sampling intermittently (not a routine monitoring burden) on fish tissue relative to the fish tissue criterion. Only when the fish tissue criterion is exceeded would a full site-specific analysis including development of intermedia translation factors be necessary.

Integrated risk framework for onsite wastewater treatment systems.

PubMed

Carroll, Steven; Goonetilleke, Ashantha; Thomas, Evan; Hargreaves, Megan; Frost, Ray; Dawes, Les

2006-08-01

Onsite wastewater treatment systems (OWTS) are becoming increasingly important for the treatment and dispersal of effluent in new urbanised developments that are not serviced by centralised wastewater collection and treatment systems. However, the current standards and guidelines adopted by many local authorities for assessing suitable site and soil conditions for OWTS are increasingly coming under scrutiny due to the public health and environmental impacts caused by poorly performing systems, in particular septic tank-soil adsorption systems. In order to achieve sustainable onsite wastewater treatment with minimal impacts on the environment and public health, more appropriate means of assessment are required. This paper highlights an integrated risk based approach for assessing the inherent hazards associated with OWTS in order to manage and mitigate the environmental and public health risks inherent with onsite wastewater treatment. In developing a sound and cohesive integrated risk framework for OWTS, several key issues must be recognised. These include the inclusion of relevant stakeholders throughout framework development, the integration of scientific knowledge, data and analysis with risk assessment and management ideals, and identification of the appropriate performance goals for successful management and mitigation of associated risks. These issues were addressed in the development of the risk framework to provide a generic approach to assessing risk from OWTS. The utilisation of the developed risk framework for achieving more appropriate assessment and management techniques for OWTS is presented in a case study for the Gold Coast region, Queensland State, Australia.

Integrated Risk Framework for Onsite Wastewater Treatment Systems

NASA Astrophysics Data System (ADS)

Carroll, Steven; Goonetilleke, Ashantha; Thomas, Evan; Hargreaves, Megan; Frost, Ray; Dawes, Les

2006-08-01

Onsite wastewater treatment systems (OWTS) are becoming increasingly important for the treatment and dispersal of effluent in new urbanised developments that are not serviced by centralised wastewater collection and treatment systems. However, the current standards and guidelines adopted by many local authorities for assessing suitable site and soil conditions for OWTS are increasingly coming under scrutiny due to the public health and environmental impacts caused by poorly performing systems, in particular septic tank-soil adsorption systems. In order to achieve sustainable onsite wastewater treatment with minimal impacts on the environment and public health, more appropriate means of assessment are required. This paper highlights an integrated risk based approach for assessing the inherent hazards associated with OWTS in order to manage and mitigate the environmental and public health risks inherent with onsite wastewater treatment. In developing a sound and cohesive integrated risk framework for OWTS, several key issues must be recognised. These include the inclusion of relevant stakeholders throughout framework development, the integration of scientific knowledge, data and analysis with risk assessment and management ideals, and identification of the appropriate performance goals for successful management and mitigation of associated risks. These issues were addressed in the development of the risk framework to provide a generic approach to assessing risk from OWTS. The utilisation of the developed risk framework for achieving more appropriate assessment and management techniques for OWTS is presented in a case study for the Gold Coast region, Queensland State, Australia.

An ICU Preanesthesia Evaluation Form Reduces Missing Preoperative Key Information.

PubMed

Chuy, Katherine; Yan, Zhe; Fleisher, Lee; Liu, Renyu

2012-09-28

A comprehensive preoperative evaluation is critical for providing anesthetic care for patients from the intensive care unit (ICU). There has been no preoperative evaluation form specific for ICU patients that allows for a rapid and focused evaluation by anesthesia providers, including junior residents. In this study, a specific preoperative form was designed for ICU patients and evaluated to allow residents to perform the most relevant and important preoperative evaluations efficiently. The following steps were utilized for developing the preoperative evaluation form: 1) designed a new preoperative form specific for ICU patients; 2) had the form reviewed by attending physicians and residents, followed by multiple revisions; 3) conducted test releases and revisions; 4) released the final version and conducted a survey; 5) compared data collection from new ICU form with that from a previously used generic form. Each piece of information on the forms was assigned a score, and the score for the total missing information was determined. The score for each form was presented as mean ± standard deviation (SD), and compared by unpaired t test. A P value < 0.05 was considered statistically significant. Of 52 anesthesiologists (19 attending physicians, 33 residents) responding to the survey, 90% preferred the final new form; and 56% thought the new form would reduce perioperative risk for ICU patients. Forty percent were unsure whether the form would reduce perioperative risk. Over a three month period, we randomly collected 32 generic forms and 25 new forms. The average score for missing data was 23 ± 10 for the generic form and 8 ± 4 for the new form (P = 2.58E-11). A preoperative evaluation form designed specifically for ICU patients is well accepted by anesthesia providers and helped to reduce missing key preoperative information. Such an approach is important for perioperative patient safety.

Summary on several key techniques in 3D geological modeling.

PubMed

Mei, Gang

2014-01-01

Several key techniques in 3D geological modeling including planar mesh generation, spatial interpolation, and surface intersection are summarized in this paper. Note that these techniques are generic and widely used in various applications but play a key role in 3D geological modeling. There are two essential procedures in 3D geological modeling: the first is the simulation of geological interfaces using geometric surfaces and the second is the building of geological objects by means of various geometric computations such as the intersection of surfaces. Discrete geometric surfaces that represent geological interfaces can be generated by creating planar meshes first and then spatially interpolating; those surfaces intersect and then form volumes that represent three-dimensional geological objects such as rock bodies. In this paper, the most commonly used algorithms of the key techniques in 3D geological modeling are summarized.

Social sensing of urban land use based on analysis of Twitter users’ mobility patterns

PubMed Central

Soltani, Kiumars; Yin, Junjun; Padmanabhan, Anand; Wang, Shaowen

2017-01-01

A number of recent studies showed that digital footprints around built environments, such as geo-located tweets, are promising data sources for characterizing urban land use. However, challenges for achieving this purpose exist due to the volume and unstructured nature of geo-located social media. Previous studies focused on analyzing Twitter data collectively resulting in coarse resolution maps of urban land use. We argue that the complex spatial structure of a large collection of tweets, when viewed through the lens of individual-level human mobility patterns, can be simplified to a series of key locations for each user, which could be used to characterize urban land use at a higher spatial resolution. Contingent issues that could affect our approach, such as Twitter users’ biases and tendencies at locations where they tweet the most, were systematically investigated using 39 million geo-located Tweets and two independent datasets of the City of Chicago: 1) travel survey and 2) parcel-level land use map. Our results support that the majority of Twitter users show a preferential return, where their digital traces are clustered around a few key locations. However, we did not find a general relation among users between the ranks of locations for an individual—based on the density of tweets—and their land use types. On the contrary, temporal patterns of tweeting at key locations were found to be coherent among the majority of users and significantly associated with land use types of these locations. Furthermore, we used these temporal patterns to classify key locations into generic land use types with an overall classification accuracy of 0.78. The contribution of our research is twofold: a novel approach to resolving land use types at a higher resolution, and in-depth understanding of Twitter users’ location-related and temporal biases, promising to benefit human mobility and urban studies in general. PMID:28723936

Social sensing of urban land use based on analysis of Twitter users' mobility patterns.

PubMed

Soliman, Aiman; Soltani, Kiumars; Yin, Junjun; Padmanabhan, Anand; Wang, Shaowen

2017-01-01

A number of recent studies showed that digital footprints around built environments, such as geo-located tweets, are promising data sources for characterizing urban land use. However, challenges for achieving this purpose exist due to the volume and unstructured nature of geo-located social media. Previous studies focused on analyzing Twitter data collectively resulting in coarse resolution maps of urban land use. We argue that the complex spatial structure of a large collection of tweets, when viewed through the lens of individual-level human mobility patterns, can be simplified to a series of key locations for each user, which could be used to characterize urban land use at a higher spatial resolution. Contingent issues that could affect our approach, such as Twitter users' biases and tendencies at locations where they tweet the most, were systematically investigated using 39 million geo-located Tweets and two independent datasets of the City of Chicago: 1) travel survey and 2) parcel-level land use map. Our results support that the majority of Twitter users show a preferential return, where their digital traces are clustered around a few key locations. However, we did not find a general relation among users between the ranks of locations for an individual-based on the density of tweets-and their land use types. On the contrary, temporal patterns of tweeting at key locations were found to be coherent among the majority of users and significantly associated with land use types of these locations. Furthermore, we used these temporal patterns to classify key locations into generic land use types with an overall classification accuracy of 0.78. The contribution of our research is twofold: a novel approach to resolving land use types at a higher resolution, and in-depth understanding of Twitter users' location-related and temporal biases, promising to benefit human mobility and urban studies in general.

MTK: An AI tool for model-based reasoning

NASA Technical Reports Server (NTRS)

Erickson, William K.; Rudokas, Mary R.

1988-01-01

A 1988 goal for the Systems Autonomy Demonstration Project Office of the NASA Ames Research Office is to apply model-based representation and reasoning techniques in a knowledge-based system that will provide monitoring, fault diagnosis, control, and trend analysis of the Space Station Thermal Control System (TCS). A number of issues raised during the development of the first prototype system inspired the design and construction of a model-based reasoning tool called MTK, which was used in the building of the second prototype. These issues are outlined here with examples from the thermal system to highlight the motivating factors behind them, followed by an overview of the capabilities of MTK, which was developed to address these issues in a generic fashion.

Dynamic issues in launch vehicle design

NASA Technical Reports Server (NTRS)

Ryan, Robert S.; Jewell, Ronald E.

1993-01-01

Launch vehicles, in general, have been defined using performance requirements and generic payload characteristics which dictated the propulsion system and the payload carrier. The vehicle concept is then selected using these requirements in conjunction with basic criteria and standards. During the design phase, the selected concept must be modified in order to cope with the numerous dynamic and other problems that occur during design and development. This is costly and is, to some extent, unnecessary. The purpose of this paper is to propose an approach for bringing the dynamic issues into focus during concept selection, where the greatest payoff exists. Delaying consideration of the issues to the design phases creates many problems, not the least of which are the impacts levied against the payload community. Volumes of information exist from prior programs on these dynamic issues and serve as the guidelines for this paper.

Inter-organizational future proof EHR systems. A review of the security and privacy related issues.

PubMed

van der Linden, Helma; Kalra, Dipak; Hasman, Arie; Talmon, Jan

2009-03-01

Identification and analysis of privacy and security related issues that occur when health information is exchanged between health care organizations. Based on a generic scenario questions were formulated to reveal the occurring issues. Possible answers were verified in literature. Ensuring secure health information exchange across organizations requires a standardization of security measures that goes beyond organizational boundaries, such as global definitions of professional roles, global standards for patient consent and semantic interoperable audit logs. As to be able to fully address the privacy and security issues in interoperable EHRs and the long-life virtual EHR it is necessary to realize a paradigm shift from storing all incoming information in a local system to retrieving information from external systems whenever that information is deemed necessary for the care of the patient.

An exploratory survey of methods used to develop measures of performance

NASA Astrophysics Data System (ADS)

Hamner, Kenneth L.; Lafleur, Charles A.

1993-09-01

Nonmanufacturing organizations are being challenged to provide high-quality products and services to their customers, with an emphasis on continuous process improvement. Measures of performance, referred to as metrics, can be used to foster process improvement. The application of performance measurement to nonmanufacturing processes can be very difficult. This research explored methods used to develop metrics in nonmanufacturing organizations. Several methods were formally defined in the literature, and the researchers used a two-step screening process to determine the OMB Generic Method was most likely to produce high-quality metrics. The OMB Generic Method was then used to develop metrics. A few other metric development methods were found in use at nonmanufacturing organizations. The researchers interviewed participants in metric development efforts to determine their satisfaction and to have them identify the strengths and weaknesses of, and recommended improvements to, the metric development methods used. Analysis of participants' responses allowed the researchers to identify the key components of a sound metrics development method. Those components were incorporated into a proposed metric development method that was based on the OMB Generic Method, and should be more likely to produce high-quality metrics that will result in continuous process improvement.

A Case Study of Pharmaceutical Pricing in China: Setting the Price for Off-Patent Originators.

PubMed

Hu, Shanlian; Zhang, Yabing; He, Jiangjiang; Du, Lixia; Xu, Mingfei; Xie, Chunyan; Peng, Ying; Wang, Linan

2015-08-01

This article aims to define a value-based approach to pricing and reimbursement for off-patent originators using a multiple criteria decision analysis (MCDA) approach centered on a systematic analysis of current pricing and reimbursement policies in China. A drug price policy review was combined with a quantitative analysis of China's drug purchasing database. Policy preferences were identified through a MCDA performed by interviewing well-known academic experts and industry stakeholders. The study findings indicate that the current Chinese price policy includes cost-based pricing and the establishment of maximum retail prices and premiums for off-patent originators, whereas reference pricing may be adopted in the future. The literature review revealed significant differences in the dissolution profiles between originators and generics; therefore, dissolution profiles need to be improved. Market data analysis showed that the overall price ratio of generics and off-patent originators was around 0.54-0.59 in 2002-2011, with a 40% price difference, on average. Ten differentiating value attributes were identified and MCDA was applied to test the impact of three pricing policy scenarios. With the condition of implementing quality consistency regulations and controls, a reduction in the price gap between high-quality off-patent products (including originator and generics) seemed to be the preferred policy. Patents of many drugs will expire within the next 10 years; thus, pricing will be an issue of importance for off-patent originators and generic alternatives.

Dating Violence among College Students: Key Issues for College Counselors

ERIC Educational Resources Information Center

Murray, Christine E.; Kardatzke, Kerrie N.

2007-01-01

The authors present a review of literature examining dating violence among college students. They describe 6 key issues related to dating violence among college students that affect college counselors' work. These key issues relate to the incidence and prevalence of physical, sexual, and psychological violence in college students' dating…

Synopsis of the cyclocephaline scarab beetles (Coleoptera, Scarabaeidae, Dynastinae)

PubMed Central

Moore, Matthew R.; Cave, Ronald D.; Branham, Marc A.

2018-01-01

Abstract The cyclocephaline scarabs (Scarabaeidae: Dynastinae: Cyclocephalini) are a speciose tribe of beetles that include species that are ecologically and economically important as pollinators and pests of agriculture and turf. We provide an overview and synopsis of the 14 genera of Cyclocephalini that includes information on: 1) the taxonomic and nomenclatural history of the group; 2) diagnosis and identification of immature life-stages; 3) economic importance in agroecosystems; 4) natural enemies of these beetles; 5) use as food by humans; 6) the importance of adults as pollination mutualists; 7) fossil cyclocephalines and the evolution of the group; 8) generic-level identification of adults. We provide an expanded identification key to genera of world Cyclocephalini and diagnoses for each genus. Character illustrations and generic-level distribution maps are provided along with discussions on the relationships of the tribe’s genera. PMID:29670448

Synopsis of the cyclocephaline scarab beetles (Coleoptera, Scarabaeidae, Dynastinae).

PubMed

Moore, Matthew R; Cave, Ronald D; Branham, Marc A

2018-01-01

The cyclocephaline scarabs (Scarabaeidae: Dynastinae: Cyclocephalini) are a speciose tribe of beetles that include species that are ecologically and economically important as pollinators and pests of agriculture and turf. We provide an overview and synopsis of the 14 genera of Cyclocephalini that includes information on: 1) the taxonomic and nomenclatural history of the group; 2) diagnosis and identification of immature life-stages; 3) economic importance in agroecosystems; 4) natural enemies of these beetles; 5) use as food by humans; 6) the importance of adults as pollination mutualists; 7) fossil cyclocephalines and the evolution of the group; 8) generic-level identification of adults. We provide an expanded identification key to genera of world Cyclocephalini and diagnoses for each genus. Character illustrations and generic-level distribution maps are provided along with discussions on the relationships of the tribe's genera.

Generic worklist handler for workflow-enabled products

NASA Astrophysics Data System (ADS)

Schmidt, Joachim; Meetz, Kirsten; Wendler, Thomas

1999-07-01

Workflow management (WfM) is an emerging field of medical information technology. It appears as a promising key technology to model, optimize and automate processes, for the sake of improved efficiency, reduced costs and improved patient care. The Application of WfM concepts requires the standardization of architectures and interfaces. A component of central interest proposed in this report is a generic work list handler: A standardized interface between a workflow enactment service and application system. Application systems with embedded work list handlers will be called 'Workflow Enabled Application Systems'. In this paper we discus functional requirements of work list handlers, as well as their integration into workflow architectures and interfaces. To lay the foundation for this specification, basic workflow terminology, the fundamentals of workflow management and - later in the paper - the available standards as defined by the Workflow Management Coalition are briefly reviewed.

Phytosanitary Irradiation

PubMed Central

Hallman, Guy J.; Blackburn, Carl M.

2016-01-01

Phytosanitary treatments disinfest traded commodities of potential quarantine pests. Phytosanitary irradiation (PI) treatments use ionizing radiation to accomplish this, and, since their international commercial debut in 2004, the use of this technology has increased by ~10% annually. Generic PI treatments (one dose is used for a group of pests and/or commodities, although not all have been tested for efficacy) are used in virtually all commercial PI treatments, and new generic PI doses are proposed, such as 300 Gy, for all insects except pupae and adult Lepidoptera (moths). Fresh fruits and vegetables tolerate PI better than any other broadly used treatment. Advances that would help facilitate the use of PI include streamlining the approval process, making the technology more accessible to potential users, lowering doses and broadening their coverage, and solving potential issues related to factors that might affect efficacy. PMID:28231103

Descriptions of eight new species of Phaelota (Coleoptera: Chrysomelidae) with a new generic synonymy and a key to species of Indian subcontinent

USDA-ARS?s Scientific Manuscript database

Six new species of Phaelota Jacoby from India viz. P. assamensis, P. kottigehara, P. maculipennis, P. mauliki, P. saluki, and P. viridipennis and two new species from Sri Lanka viz. P. ogloblini and P. schereri are described and illustrated. Thrylaea Jacoby is treated as a new junior synonym of Phae...

A new record and two new species of Cryptochironomus Kieffer, 1918 from China (Diptera, Chironomidae).

PubMed

Yan, Chuncai; Zhao, Guangjun; Liu, Ting; Guo, Qin; Hou, Ziyuan; Wang, Xinhua; Pan, Baoping

2016-12-19

Two new species of the genus Cryptochironomus Kieffer, C. maculus Yan & Wang sp. n. and C. protuberans Yan & Wang sp. n. are described and illustrated as adult males. C. albofasciatus (Staeger) is recorded from China for the first time. A key to the males of Cryptochironomus in China is presented and generic diagnosis is emended.

Assessing Individual Lessons Using a Generic Teacher Observation Instrument: How Useful Is the International System for Teacher Observation and Feedback (ISTOF)?

ERIC Educational Resources Information Center

Muijs, Daniel; Reynolds, David; Sammons, Pamela; Kyriakides, Leonidas; Creemers, Bert P. M.; Teddlie, Charles

2018-01-01

Teacher effectiveness, which impacts student attainment even when controlling for student characteristics, is of key importance as a factor in educational effectiveness and improvement. Improving the quality of teaching is thus the primary means by which we can enhance student learning outcomes. Thus there has long been great interest in the…

Thumbtops as Learning Tools: From "Development for Learning" to "Learner as Developer"

ERIC Educational Resources Information Center

Lim, Kenneth Y. T.; Chen, Der-Thanq; Hung, David

2010-01-01

This article describes some of the key affordances for learning of the generic class of handheld computers known variously as smartphones, palmtops, and thumbtops--using the Apple iPhone 3G as one of the most mature exemplars of this class--based on the authors' experiences with and reflections about the device over a period of a year. An argument…

Opening the black box of transfer systems in public sector health services in a Western state in India.

PubMed

Purohit, Bhaskar; Martineau, Tim; Sheikh, Kabir

2016-08-22

Limited research on Posting and Transfer (P&T) policies and systems in the public sector health services and the reluctance for an open debate on the issue makes P&T as a black box. Limited research on P&T in India suggests that P&T policies and systems are either non-existent, weak, poorly implemented or characterized by corruption. Hence the current study aimed at opening the "black box" of P&T systems in public sector health services in India by assessing the implementation gaps between P&T policies and their actual implementation. This was a qualitative study carried out in Department of Health, in a Western State in India. To understand the extant P&T policies, a systems map was first developed with the help of document review and Key Informant (KI) Interviews. Next systems audit was carried out to assess the actual implementation of transfer policies by interviewing Medical Officers (MOs), the group mainly affected by the P&T policies. Job histories were constructed from the interviews to understand transfer processes like frequencies of transfers and to assess if transfer rules were adhered. The analysis is based on a synthesis of document review, 19 in-depth interviews with MOs working with state health department and five in-depth interviews with Key Informants (KIs). Framework analysis approach was used to analyze data using NVIVO. The state has a generic transfer guideline applicable to all government officers but there is no specific transfer policy or guideline for government health personnel. The generic transfer guidelines are weakly implemented indicating a significant gap between policy and actual implementation. The formal transfer guidelines are undermined by a parallel system in which desirable posts are attained, retained or sometimes given up by the use of political connections and money. MOs' experiences of transfers were marked by perceptions of unfairness and irregularities reflected through interviews as well as the job histories. The generic transfer rules and ambiguity in how transfers are treated may explain the discrepancy between policy and implementation leading to systems abuse. This discrepancy could have negative influence on MOs' morale which could in turn affect distribution of MOs. Where possible, ambiguity in the rules should be avoided and a greater transparency on implementation of the transfer rules is needed. However, it may not be possible to make any significant improvements to P&T policies and how they are implemented until the external pressure that creates parallel systems is greatly reduced in translating HR policy into HR practice. Effective P&T policies and implementation may have important implications for organizational performance and may help to improve Human Resource (HR) policy and HR expertise. Also there is a greater need for transparency on implementation of the rules. However, it may not be possible to make any significant improvements to P&T policies and how they are implemented until the external pressure that creates parallel systems is greatly reduced.

Advanced control techniques for teleoperation in earth orbit

NASA Technical Reports Server (NTRS)

Bejczy, A. K.; Brooks, T. L.

1980-01-01

Emerging teleoperation tasks in space invite advancements in teleoperator control technology. This paper briefly summarizes the generic issues related to earth orbital applications of teleoperators, and describes teleoperator control technology development work including visual and non-visual sensors and displays, kinesthetic feedback and computer-aided controls. Performance experiments were carried out using sensor and computer aided controls with promising results which are briefly summarized.

Quality Assurance in Education: Current Debates. A Report on a SOED-Sponsored Seminar (Stirling, Scotland, United Kingdom, June 1992).

ERIC Educational Resources Information Center

Stronach, Ian, Ed.

Proceedings of a workshop held at the University of Stirling, Scotland, to critically examine issues in quality assurance (QA) in education are provided in this document. QA is the generic title for a series of business-management models that have been applied to educational contexts to describe and promote school effectiveness. Five papers and…

An Assessment of the Nature and Extent of Community and Employee Fitness Programs and Levels of Participation. Final Report. Report No. 9.

ERIC Educational Resources Information Center

Bozzo, Robert; And Others

This report presents an assessment and comparison of the nature and extent of general population, employee, and school fitness programs. Chapter I provides an overview of the research effort and the research questions developed as a framework for delineating issues to be examined. Chapter II identifies the generic approach used to examine the…

Speaking Personally about Distance Education: Foundations of Contemporary Practice. Readings in Distance Education, Number 6.

ERIC Educational Resources Information Center

Moore, Michael G., Ed.; Shin, Namin, Ed.

"Speaking Personally" is the generic name given to one of the regular features of "The American Journal of Distance Education"--AJDE--an interview with a leading personality in the field. As implied in the title, interviewees have always been encouraged to talk in a relatively informal way. Since an interview has been reported in every issue of…

The Need for Deeper Roots: Making a Mission-Driven Case for Poverty-Related Issues in Business Education

ERIC Educational Resources Information Center

Naughton, Michael; de la Cruz, Rachelle

2016-01-01

We begin with the argument that if universities are to form and educate future business leaders with a disciplined sensitivity to those who suffer from both material and spiritual poverty, they will be most successful when they draw upon a mission that has a deeper root system than generic values or instrumental rationality. Recognizing that…

Volunteer, lay tutors' experiences of the Chronic Disease Self-Management Course: being valued and adding value.

PubMed

Barlow, J H; Bancroft, G V; Turner, A P

2005-04-01

Chronic disease is a public health issue that could be addressed, in part, by increasing the ability of individuals to better manage their condition and its consequences on a day-to-day basis. One intervention designed to facilitate this is the Chronic Disease Self Management Course (CDSMC) that is delivered by volunteer, lay tutors who themselves have a chronic disease. Although there is growing evidence of course effectiveness for participants, the experiences of tutors have been neglected. This study aims to address this omission. Telephone interviews were conducted with 11 (six male) tutors: all interviews were transcribed and thematically analysed. Being a volunteer lay-tutor was perceived to be an enjoyable and valuable experience despite the challenges associated with course delivery, such as organizational demands and managing the diverse needs of mixed groups of chronic disease participants that led to a tension between disease-specific needs and the generic approach of the course. Being valued and adding value to the lives of others were key benefits of being a volunteer tutor, along with increased confidence that they were doing something positive for others. Course delivery prompted the initiation and maintenance of tutors' own self-management behaviours.

Education of advanced practice nurses in Canada.

PubMed

Martin-Misener, Ruth; Bryant-Lukosius, Denise; Harbman, Patricia; Donald, Faith; Kaasalainen, Sharon; Carter, Nancy; Kilpatrick, Kelley; DiCenso, Alba

2010-12-01

In Canada, education programs for the clinical nurse specialist (CNS) and nurse practitioner (NP) roles began 40 years ago. NP programs are offered in almost all provinces. Education for the CNS role has occurred through graduate nursing programs generically defined as providing preparation for advanced nursing practice. For this paper, we drew on pertinent sections of a scoping review of the literature and key informant interviews conducted for a decision support synthesis on advanced practice nursing to describe the following: (1) history of advanced practice nursing education in Canada, (2) current status of advanced practice nursing education in Canada, (3) curriculum issues, (4) interprofessional education, (5) resources for education and (6) continuing education. Although national frameworks defining advanced nursing practice and NP competencies provide some direction for education programs, Canada does not have countrywide standards of education for either the NP or CNS role. Inconsistency in the educational requirements for primary healthcare NPs continues to cause significant problems and interferes with inter-jurisdictional licensing portability. For both CNSs and NPs, there can be a mismatch between a generalized education and specialized practice. The value of interprofessional education in facilitating effective teamwork is emphasized. Recommendations for future directions for advanced practice nursing education are offered.

Use of job-exposure matrices to estimate occupational exposure to pesticides: A review.

PubMed

Carles, Camille; Bouvier, Ghislaine; Lebailly, Pierre; Baldi, Isabelle

2017-03-01

The health effects of pesticides have been extensively studied in epidemiology, mainly in agricultural populations. However, pesticide exposure assessment remains a key methodological issue for epidemiological studies. Besides self-reported information, expert assessment or metrology, job-exposure matrices still appear to be an interesting tool. We reviewed all existing matrices assessing occupational exposure to pesticides in epidemiological studies and described the exposure parameters they included. We identified two types of matrices, (i) generic ones that are generally used in case-control studies and document broad categories of pesticides in a large range of jobs, and (ii) specific matrices, developed for use in agricultural cohorts, that generally provide exposure metrics at the active ingredient level. The various applications of these matrices in epidemiological studies have proven that they are valuable tools to assess pesticide exposure. Specific matrices are particularly promising for use in agricultural cohorts. However, results obtained with matrices have rarely been compared with those obtained with other tools. In addition, the external validity of the given estimates has not been adequately discussed. Yet, matrices would help in reducing misclassification and in quantifying cumulated exposures, to improve knowledge about the chronic health effects of pesticides.

HIV and the Right to Health in Colombia

PubMed Central

Villar de Onís, Jimena

2016-01-01

Abstract The first Colombian to claim a judicially enforceable right to health was a gay man living with HIV, who in 1992 claimed a violation of his constitutional rights on account of being denied antiretroviral therapy. Since then, HIV activists have been at the forefront of advancing both the judicialization and social reconstruction of health as a human right. However, their role—and its implications today—has been sometimes overlooked in the study of Colombia’s right to health. Based on semi-structured interviews with key stakeholders, we evaluate the HIV movement’s effect on the progression of the right to health and resulting health care reform, and analyze the reform’s success in addressing the needs of people living with HIV. While the landmark Constitutional Court decision T-760 and resulting health care reform are not the result of any one group, the HIV movement played a significant role in these developments, and its values are largely reflected in the country’s new sociopolitical conceptualization of the right to health. However, the movement has faced division over the issue of generic medication availability and among subpopulations who have not been strongly represented or consistent beneficiaries of its successes. PMID:28559683

Investigating Integration Capabilities Between Ifc and Citygml LOD3 for 3d City Modelling

NASA Astrophysics Data System (ADS)

Floros, G.; Pispidikis, I.; Dimopoulou, E.

2017-10-01

Smart cities are applied to an increasing number of application fields. This evolution though urges data collection and integration, hence major issues arise that need to be tackled. One of the most important challenges is the heterogeneity of collected data, especially if those data derive from different standards and vary in terms of geometry, topology and semantics. Another key challenge is the efficient analysis and visualization of spatial data, which due to the complexity of the physical reality in modern world, 2D GIS struggles to cope with. So, in order to facilitate data analysis and enhance the role of smart cities, the 3rd dimension needs to be implemented. Standards such as CityGML and IFC fulfill that necessity but they present major differences in their schemas that render their integration a challenging task. This paper focuses on addressing those differences, examining the up to date research work and investigates an alternative methodology in order to bridge the gap between those Standards. Within this framework, a generic IFC model is generated and converted to a CityGML Model, which is validated and evaluated on its geometrical correctness and semantical coherence. General results as well as future research considerations are presented.

How much could be saved in Chinese hospitals in procurement of anti-hypertensives and anti-diabetics?

PubMed

Sun, Jing; Ren, Luo; Wirtz, Veronika

2016-09-01

Efficient use of government funding has been increasingly relevant for the success and sustainability of ongoing health-system reform in China; however, as there is no generic substitution policy, patients and basic health-insurance programs pay more for public-preferred brand originators. Such phenomenon is especially typical in public hospitals. The objective of this study is to estimate the potential cost savings in procurement by Chinese public hospitals when switching from brand originators of anti-hypertensive and anti-diabetic medications to their generic equivalents between 2012-2014. IMS Health volume and value consumption data (IMS China Hospitals Audit system 2012-2014) were used, which covered all Chinese hospitals with 100 beds and above. The top 60% IMS volume consumption of respective anti-hypertensive and anti-diabetic medication with unique dosage form and strength were included. The potential cost savings were calculated from a switch of brand originators with their generic equivalents on the Chinese and international market. An independent sample t-test was conducted to compare the difference of proportion of cost savings in value between the Chinese and international market. An average of 44% (US$44 million) and 87% (US$90 million) and a total of US$1.4 and 2.8 billion (2014 US$) could be saved from a switch from originator brand anti-hypertensives and anti-diabetics to domestically and internationally available generic equivalents, respectively. The differences of cost savings (in proportion) between domestic and international market were statistically significant (α = 0.005, p = 0.003, p = 0.002, p = 0.000). Expensive brand originators dominated the anti-hypertensive and anti-diabetic market in Chinese hospitals between 2012-2014. Preference of brand originators wastes a huge amount of health resources in China and these limited resources could have been used more efficiently. As one of the world's key generic suppliers, if China wants to use its health resource more efficiently on medicines, comprehensive measures are needed to address both demand-side (consumers' low trust in the quality of local generics) and supply-side barriers (health professionals' preference of brand originators).

Summary on Several Key Techniques in 3D Geological Modeling

PubMed Central

2014-01-01

Several key techniques in 3D geological modeling including planar mesh generation, spatial interpolation, and surface intersection are summarized in this paper. Note that these techniques are generic and widely used in various applications but play a key role in 3D geological modeling. There are two essential procedures in 3D geological modeling: the first is the simulation of geological interfaces using geometric surfaces and the second is the building of geological objects by means of various geometric computations such as the intersection of surfaces. Discrete geometric surfaces that represent geological interfaces can be generated by creating planar meshes first and then spatially interpolating; those surfaces intersect and then form volumes that represent three-dimensional geological objects such as rock bodies. In this paper, the most commonly used algorithms of the key techniques in 3D geological modeling are summarized. PMID:24772029

Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL 4.0 Generic Core Scales.

PubMed

Varni, James W; Limbers, Christine A; Burwinkle, Tasha M

2007-07-16

Advances in biomedical science and technology have resulted in dramatic improvements in the healthcare of pediatric chronic conditions. With enhanced survival, health-related quality of life (HRQOL) issues have become more salient. The objectives of this study were to compare generic HRQOL across ten chronic disease clusters and 33 disease categories/severities from the perspectives of patients and parents. Comparisons were also benchmarked with healthy children data. The analyses were based on over 2,500 pediatric patients from 10 physician-diagnosed disease clusters and 33 disease categories/severities and over 9,500 healthy children utilizing the PedsQL 4.0 Generic Core Scales. Patients were recruited from general pediatric clinics, subspecialty clinics, and hospitals. Pediatric patients with diabetes, gastrointestinal conditions, cardiac conditions, asthma, obesity, end stage renal disease, psychiatric disorders, cancer, rheumatologic conditions, and cerebral palsy self-reported progressively more impaired overall HRQOL than healthy children, respectively, with medium to large effect sizes. Patients with cerebral palsy self-reported the most impaired HRQOL, while patients with diabetes self-reported the best HRQOL. Parent proxy-reports generally paralleled patient self-report, with several notable differences. The results demonstrate differential effects of pediatric chronic conditions on patient HRQOL across diseases clusters, categories, and severities utilizing the PedsQL 4.0 Generic Core Scales from the perspectives of pediatric patients and parents. The data contained within this study represents a larger and more diverse population of pediatric patients with chronic conditions than previously reported in the extant literature. The findings contribute important information on the differential effects of pediatric chronic conditions on generic HRQOL from the perspectives of children and parents utilizing the PedsQL 4.0 Generic Core Scales. These findings with the PedsQL have clinical implications for the healthcare services provided for children with chronic health conditions. Given the degree of reported impairment based on PedsQL scores across different pediatric chronic conditions, the need for more efficacious targeted treatments for those pediatric patients with more severely impaired HRQOL is clearly and urgently indicated.

Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL™ 4.0 Generic Core Scales

PubMed Central

Varni, James W; Limbers, Christine A; Burwinkle, Tasha M

2007-01-01

Background Advances in biomedical science and technology have resulted in dramatic improvements in the healthcare of pediatric chronic conditions. With enhanced survival, health-related quality of life (HRQOL) issues have become more salient. The objectives of this study were to compare generic HRQOL across ten chronic disease clusters and 33 disease categories/severities from the perspectives of patients and parents. Comparisons were also benchmarked with healthy children data. Methods The analyses were based on over 2,500 pediatric patients from 10 physician-diagnosed disease clusters and 33 disease categories/severities and over 9,500 healthy children utilizing the PedsQL™ 4.0 Generic Core Scales. Patients were recruited from general pediatric clinics, subspecialty clinics, and hospitals. Results Pediatric patients with diabetes, gastrointestinal conditions, cardiac conditions, asthma, obesity, end stage renal disease, psychiatric disorders, cancer, rheumatologic conditions, and cerebral palsy self-reported progressively more impaired overall HRQOL than healthy children, respectively, with medium to large effect sizes. Patients with cerebral palsy self-reported the most impaired HRQOL, while patients with diabetes self-reported the best HRQOL. Parent proxy-reports generally paralleled patient self-report, with several notable differences. Conclusion The results demonstrate differential effects of pediatric chronic conditions on patient HRQOL across diseases clusters, categories, and severities utilizing the PedsQL™ 4.0 Generic Core Scales from the perspectives of pediatric patients and parents. The data contained within this study represents a larger and more diverse population of pediatric patients with chronic conditions than previously reported in the extant literature. The findings contribute important information on the differential effects of pediatric chronic conditions on generic HRQOL from the perspectives of children and parents utilizing the PedsQL™ 4.0 Generic Core Scales. These findings with the PedsQL™ have clinical implications for the healthcare services provided for children with chronic health conditions. Given the degree of reported impairment based on PedsQL™ scores across different pediatric chronic conditions, the need for more efficacious targeted treatments for those pediatric patients with more severely impaired HRQOL is clearly and urgently indicated. PMID:17634123

The EVOTION Decision Support System: Utilizing It for Public Health Policy-Making in Hearing Loss.

PubMed

Katrakazas, Panagiotis; Trenkova, Lyubov; Milas, Josip; Brdaric, Dario; Koutsouris, Dimitris

2017-01-01

As Decision Support Systems start to play a significant role in decision making, especially in the field of public-health policy making, we present an initial attempt to formulate such a system in the concept of public health policy making for hearing loss related problems. Justification for the system's conceptual architecture and its key functionalities are presented. The introduction of the EVOTION DSS sets a key innovation and a basis for paradigm shift in policymaking, by incorporating relevant models, big data analytics and generic demographic data. Expected outcomes for this joint effort are discussed from a public-health point of view.

76 FR 26290 - Science Advisory Board Staff Office; Notification of a Public Teleconference of the Chartered...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-06

... report entitled ``SAB Review of EPA's Reanalysis of Key Issues Related to Dioxin Toxicity and Response to... of EPA's Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments.'' The SAB... Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments.'' To conduct this review...

Computational and experimental aftbody flow fields for hypersonic, airbreathing configurations with scramjet exhaust flow simulation

NASA Technical Reports Server (NTRS)

Huebner, Lawrence D.; Tatum, Kenneth E.

1991-01-01

Computational results are presented for three issues pertinent to hypersonic, airbreathing vehicles employing scramjet exhaust flow simulation. The first issue consists of a comparison of schlieren photographs obtained on the aftbody of a cruise missile configuration under powered conditions with two-dimensional computational solutions. The second issue presents the powered aftbody effects of modeling the inlet with a fairing to divert the external flow as compared to an operating flow-through inlet on a generic hypersonic vehicle. Finally, a comparison of solutions examining the potential of testing powered configurations in a wind-off, instead of a wind-on, environment, indicate that, depending on the extent of the three-dimensional plume, it may be possible to test aftbody powered hypersonic, airbreathing configurations in a wind-off environment.

Improving the Rainbow Attack by Reusing Colours

NASA Astrophysics Data System (ADS)

Ågren, Martin; Johansson, Thomas; Hell, Martin

Hashing or encrypting a key or a password is a vital part in most network security protocols. The most practical generic attack on such schemes is a time memory trade-off attack. Such an attack inverts any one-way function using a trade-off between memory and execution time. Existing techniques include the Hellman attack and the rainbow attack, where the latter uses different reduction functions ("colours") within a table.

Device-independent quantum key distribution

NASA Astrophysics Data System (ADS)

Hänggi, Esther

2010-12-01

In this thesis, we study two approaches to achieve device-independent quantum key distribution: in the first approach, the adversary can distribute any system to the honest parties that cannot be used to communicate between the three of them, i.e., it must be non-signalling. In the second approach, we limit the adversary to strategies which can be implemented using quantum physics. For both approaches, we show how device-independent quantum key distribution can be achieved when imposing an additional condition. In the non-signalling case this additional requirement is that communication is impossible between all pairwise subsystems of the honest parties, while, in the quantum case, we demand that measurements on different subsystems must commute. We give a generic security proof for device-independent quantum key distribution in these cases and apply it to an existing quantum key distribution protocol, thus proving its security even in this setting. We also show that, without any additional such restriction there always exists a successful joint attack by a non-signalling adversary.

Added value of involving patients in the first step of multidisciplinary guideline development: a qualitative interview study among infertile patients.

PubMed

den Breejen, Elvira M E; Hermens, Rosella P M G; Galama, Wienke H; Willemsen, Wim N P; Kremer, Jan A M; Nelen, Willianne L D M

2016-06-01

Patient involvement in scoping the guideline is emphasized, but published initiatives actively involving patients are generally limited to the writing and reviewing phase. To assess patients' added value to the scoping phase of a multidisciplinary guideline on infertility. Qualitative interview study. We conducted interviews among 12 infertile couples and 17 professionals. We listed and compared the couples' and professionals' key clinical issues (=care aspects that need improvement) to be addressed in the guideline according to four domains: current guidelines, professionals, patients and organization of care. Main key clinical issues suggested by more than three quarters of the infertile couples and/or at least two professionals were identified and compared. Overall, we identified 32 key clinical issues among infertile couples and 23 among professionals. Of the defined main key clinical issues, infertile couples mentioned eight issues that were not mentioned by the professionals. These main key clinical issues mainly concerned patient-centred (e.g. poor information provision and poor alignment of care) aspects of care on the professional and organizational domain. Both groups mentioned two main key clinical issues collectively that were interpreted differently: the lack of emotional support and respect for patients' values. Including patients from the first phase of the guideline development process leads to valuable additional main key clinical issues for the next step of a multidisciplinary guideline development process and broadens the scope of the guideline, particularly regarding patient-centredness and organizational issues from a patients' perspective. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Astrophysical payload accommodation on the space station

NASA Technical Reports Server (NTRS)

Woods, B. P.

1985-01-01

Surveys of potential space station astrophysics payload requirements and existing point mount design concepts were performed to identify potential design approaches for accommodating astrophysics instruments from space station. Most existing instrument pointing systems were designed for operation from the space shuttle and it is unlikely that they will sustain their performance requirements when exposed to the space station disturbance environment. The technology exists or is becoming available so that precision pointing can be provided from the space station manned core. Development of a disturbance insensitive pointing mount is the key to providing a generic system for space station. It is recommended that the MSFC Suspended Experiment Mount concept be investigated for use as part of a generic pointing mount for space station. Availability of a shirtsleeve module for instrument change out, maintenance and repair is desirable from the user's point of view. Addition of a shirtsleeve module on space station would require a major program commitment.

Aerodynamic design of electric and hybrid vehicles: A guidebook

NASA Technical Reports Server (NTRS)

Kurtz, D. W.

1980-01-01

A typical present-day subcompact electric hybrid vehicle (EHV), operating on an SAE J227a D driving cycle, consumes up to 35% of its road energy requirement overcoming aerodynamic resistance. The application of an integrated system design approach, where drag reduction is an important design parameter, can increase the cycle range by more than 15%. This guidebook highlights a logic strategy for including aerodynamic drag reduction in the design of electric and hybrid vehicles to the degree appropriate to the mission requirements. Backup information and procedures are included in order to implement the strategy. Elements of the procedure are based on extensive wind tunnel tests involving generic subscale models and full-scale prototype EHVs. The user need not have any previous aerodynamic background. By necessity, the procedure utilizes many generic approximations and assumptions resulting in various levels of uncertainty. Dealing with these uncertainties, however, is a key feature of the strategy.

Leisure and Pleasure: Science events in unusual locations

NASA Astrophysics Data System (ADS)

Bultitude, Karen; Margarida Sardo, Ana

2012-12-01

Building on concepts relating to informal science education, this work compares science-related activities which successfully engaged public audiences at three different 'generic' locations: a garden festival, a public park, and a music festival. The purpose was to identify what factors contribute to the perceived success of science communication activities occurring within leisure spaces. This article reports the results of 71 short (2-3 min) structured interviews with public participants at the events, and 18 structured observations sessions, demonstrating that the events were considered both novel and interesting by the participants. Audience members were found to perceive both educational and affective purposes from the events. Three key elements were identified as contributing to the success of the activities across the three 'generic venues': the informality of the surroundings, the involvement of 'real' scientists, and the opportunity to re-engage participants with scientific concepts outside formal education.

Population biological principles of drug-resistance evolution in infectious diseases.

PubMed

zur Wiesch, Pia Abel; Kouyos, Roger; Engelstädter, Jan; Regoes, Roland R; Bonhoeffer, Sebastian

2011-03-01

The emergence of resistant pathogens in response to selection pressure by drugs and their possible disappearance when drug use is discontinued are evolutionary processes common to many pathogens. Population biological models have been used to study the dynamics of resistance in viruses, bacteria, and eukaryotic microparasites both at the level of the individual treated host and of the treated host population. Despite the existence of generic features that underlie such evolutionary dynamics, different conclusions have been reached about the key factors affecting the rate of resistance evolution and how to best use drugs to minimise the risk of generating high levels of resistance. Improved understanding of generic versus specific population biological aspects will help to translate results between different studies, and allow development of a more rational basis for sustainable drug use than exists at present. Copyright © 2011 Elsevier Ltd. All rights reserved.

On some Cuban species of the genus Longior Travassos & Kloss, 1958 (Oxyurida, Hystrignathidae), with description of a new species

PubMed Central

Morffe, Jans; García, Nayla

2011-01-01

Abstract Longior zayasi Coy, García & Alvarez, 1993 is established as incertae sedis because the males (declared as the holotype) are inconsistent with the generic diagnosis, particularly in relation to the morphology of the head and tail. Thus, the females of Longior zayasi species (which agree with the generic diagnosis) are renamed and re-described as Longior longior Morffe & García sp. n. We also described males found in the sample and considered as conspecific with the new species. A comparative table with the measurements of the most of the records of Longior longior is given. The male of Longior similis Morffe, García & Ventosa, 2009 is described from the type locality of the species and compared with the known males of the genus. A key to the females of the Cuban Longior is given. PMID:21594153

A view of software management issues

NASA Technical Reports Server (NTRS)

Manley, J. H.

1985-01-01

The Software Development Environment (SDE) Panel addressed key programmatic, scope, and structural issues raised by its members and the general audience regarding the proposed software development environment for the Space Station program. The general team approach taken by this group led to a consensus on 18 recommendations to NASA mangament regarding the acquisition and definition of the SDE. This approach was keyed by the initial issues presentation given to the general audience. Additional issues (for a total of 23) were developed by the panelists in their first closed session from which key areas were selected and discussed in open session. These discussions led to key recommendations which are summarized and described.

Multiple criteria decision analysis for health technology assessment.

PubMed

Thokala, Praveen; Duenas, Alejandra

2012-12-01

Multicriteria decision analysis (MCDA) has been suggested by some researchers as a method to capture the benefits beyond quality adjusted life-years in a transparent and consistent manner. The objectives of this article were to analyze the possible application of MCDA approaches in health technology assessment and to describe their relative advantages and disadvantages. This article begins with an introduction to the most common types of MCDA models and a critical review of state-of-the-art methods for incorporating multiple criteria in health technology assessment. An overview of MCDA is provided and is compared against the current UK National Institute for Health and Clinical Excellence health technology appraisal process. A generic MCDA modeling approach is described, and the different MCDA modeling approaches are applied to a hypothetical case study. A comparison of the different MCDA approaches is provided, and the generic issues that need consideration before the application of MCDA in health technology assessment are examined. There are general practical issues that might arise from using an MCDA approach, and it is suggested that appropriate care be taken to ensure the success of MCDA techniques in the appraisal process. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Generic extravehicular (EVA) and telerobot task primitives for analysis, design, and integration. Version 1.0: Reference compilation for the EVA and telerobotics communities

NASA Technical Reports Server (NTRS)

Smith, Jeffrey H.; Drews, Michael

1990-01-01

The results are described of an effort to establish commonality and standardization of generic crew extravehicular (crew-EVA) and telerobotic task analysis primitives used for the study of spaceborne operations. Although direct crew-EVA plans are the most visible output of spaceborne operations, significant ongoing efforts by a wide variety of projects and organizations also require tools for estimation of crew-EVA and telerobotic times. Task analysis tools provide estimates for input to technical and cost tradeoff studies. A workshop was convened to identify the issues and needs to establish a common language and syntax for task analysis primitives. In addition, the importance of such a syntax was shown to have precedence over the level to which such a syntax is applied. The syntax, lists of crew-EVA and telerobotic primitives, and the data base in diskette form are presented.

Evaluation of RxNorm for Medication Clinical Decision Support.

PubMed

Freimuth, Robert R; Wix, Kelly; Zhu, Qian; Siska, Mark; Chute, Christopher G

2014-01-01

We evaluated the potential use of RxNorm to provide standardized representations of generic drug name and route of administration to facilitate management of drug lists for clinical decision support (CDS) rules. We found a clear representation of generic drug name but not route of administration. We identified several issues related to data quality, including erroneous or missing defined relationships, and the use of different concept hierarchies to represent the same drug. More importantly, we found extensive semantic precoordination of orthogonal concepts related to route and dose form, which would complicate the use of RxNorm for drug-based CDS. This study demonstrated that while RxNorm is a valuable resource for the standardization of medications used in clinical practice, additional work is required to enhance the terminology so that it can support expanded use cases, such as managing drug lists for CDS.

Evaluation of RxNorm for Medication Clinical Decision Support

PubMed Central

Freimuth, Robert R.; Wix, Kelly; Zhu, Qian; Siska, Mark; Chute, Christopher G.

2014-01-01

We evaluated the potential use of RxNorm to provide standardized representations of generic drug name and route of administration to facilitate management of drug lists for clinical decision support (CDS) rules. We found a clear representation of generic drug name but not route of administration. We identified several issues related to data quality, including erroneous or missing defined relationships, and the use of different concept hierarchies to represent the same drug. More importantly, we found extensive semantic precoordination of orthogonal concepts related to route and dose form, which would complicate the use of RxNorm for drug-based CDS. This study demonstrated that while RxNorm is a valuable resource for the standardization of medications used in clinical practice, additional work is required to enhance the terminology so that it can support expanded use cases, such as managing drug lists for CDS. PMID:25954360

Linkage of additional contents to moving objects and video shots in a generic media framework for interactive television

NASA Astrophysics Data System (ADS)

Lopez, Alejandro; Noe, Miquel; Fernandez, Gabriel

2004-10-01

The GMF4iTV project (Generic Media Framework for Interactive Television) is an IST European project that consists of an end-to-end broadcasting platform providing interactivity on heterogeneous multimedia devices such as Set-Top-Boxes and PCs according to the Multimedia Home Platform (MHP) standard from DVB. This platform allows the content providers to create enhanced audiovisual contents with a degree of interactivity at moving object level or shot change from a video. The end user is then able to interact with moving objects from the video or individual shots allowing the enjoyment of additional contents associated to them (MHP applications, HTML pages, JPEG, MPEG4 files...). This paper focus the attention to the issues related to metadata and content transmission, synchronization, signaling and bitrate allocation of the GMF4iTV project.

Faunus: An object oriented framework for molecular simulation

PubMed Central

Lund, Mikael; Trulsson, Martin; Persson, Björn

2008-01-01

Background We present a C++ class library for Monte Carlo simulation of molecular systems, including proteins in solution. The design is generic and highly modular, enabling multiple developers to easily implement additional features. The statistical mechanical methods are documented by extensive use of code comments that – subsequently – are collected to automatically build a web-based manual. Results We show how an object oriented design can be used to create an intuitively appealing coding framework for molecular simulation. This is exemplified in a minimalistic C++ program that can calculate protein protonation states. We further discuss performance issues related to high level coding abstraction. Conclusion C++ and the Standard Template Library (STL) provide a high-performance platform for generic molecular modeling. Automatic generation of code documentation from inline comments has proven particularly useful in that no separate manual needs to be maintained. PMID:18241331

A call for a moratorium on the .health generic top-level domain: preventing the commercialization and exclusive control of online health information.

PubMed

Mackey, Tim K; Eysenbach, Gunther; Liang, Bryan A; Kohler, Jillian C; Geissbuhler, Antoine; Attaran, Amir

2014-09-26

In just a few weeks, the Internet could be expanded to include a new .health generic top-level domain name run by a for-profit company with virtually no public health credentials - unless the international community intervenes immediately. This matters to the future of global public health as the "Health Internet" has begun to emerge as the predominant source of health information for consumers and patients. Despite this increasing use and reliance on online health information that may have inadequate quality or reliability, the Internet Corporation for Assigned Names and Numbers (ICANN) recently announced it intends to move forward with an auction to award the exclusive, 10 year rights to the .health generic top-level domain name. This decision is being made over the protests of the World Medical Association, World Health Organization, and other stakeholders, who have called for a suspension or delay until key questions can be resolved. However, rather than engage in constructive dialogue with the public health community over its concerns, ICANN chose the International Chamber of Commerce-a business lobbying group for industries to adjudicate the .health concerns. This has resulted in a rejection of challenges filed by ICANN's own independent watchdog and others, such that ICANN's Board decided in June 2014 that there are "no noted objections to move forward" in auctioning the .health generic top-level domain name to the highest bidder before the end of the year. This follows ICANN's award of several other health-related generic top-level domain names that have been unsuccessfully contested. In response, we call for an immediate moratorium/suspension of the ICANN award/auction process in order to provide the international public health community time to ensure the proper management and governance of health information online.

Systematic conversion to generic tacrolimus in stable kidney transplant recipients.

PubMed

Rosenborg, Staffan; Nordström, Annica; Almquist, Tora; Wennberg, Lars; Bárány, Peter

2014-04-01

Tacrolimus (Prograf ® ) is a key drug in the immunosuppressive treatment of renal transplant patients. Since the expiration of the patent for Prograf ® , generic preparations have been approved in Europe as bioequivalence has been shown in healthy volunteers. However, few studies have investigated whether patients can be successfully converted from Prograf ® to generic tacrolimus. Tacrolimus drug costs are by far the largest single item in the total drug expenditure for patients with renal disease in the Stockholm area. Considerable reductions in drug costs could be achieved if generic tacrolimus were to be used. The aim of this quality assurance study was to evaluate whether a switch from Prograf ® to generic tacrolimus (Tacrolimus Sandoz ® ) could be safely performed in renal transplant patients. It further aimed to investigate changes of renal function (measured in estimated glomerular filtration rate, eGFR), need for dose changes and to calculate potential drug cost savings as a result of the conversion. We planned to recruit at least 50 patients. Plasma creatinine levels and trough concentrations of tacrolimus were collected from patients with renal transplants at three occasions during treatment with Prograf ® and three times after conversion to Tacrolimus Sandoz ® . The eGFR was calculated before and after the conversion. Sixty-three of 67 enrolled patients (69% males, age 28-80 years) are included in this analysis. The ratio of mean trough concentrations of tacrolimus after comparison with before conversion was 1.02 (90% confidence interval 0.95-1.09). Fourteen patients experienced a change in tacrolimus levels >20% compared with baseline, no patients changed >20% in eGFR. The drug cost saving per daily dose was 33.40 SEK (∼€3.60, -23%). Stable kidney transplant patients treated with Prograf ® can be converted to Tacrolimus Sandoz ® if trough concentrations of tacrolimus and plasma creatinine levels are closely monitored. The conversion brought savings, despite costs for extra monitoring.

Systematic conversion to generic tacrolimus in stable kidney transplant recipients

PubMed Central

Rosenborg, Staffan; Nordström, Annica; Almquist, Tora; Wennberg, Lars; Bárány, Peter

2014-01-01

Background Tacrolimus (Prograf®) is a key drug in the immunosuppressive treatment of renal transplant patients. Since the expiration of the patent for Prograf®, generic preparations have been approved in Europe as bioequivalence has been shown in healthy volunteers. However, few studies have investigated whether patients can be successfully converted from Prograf® to generic tacrolimus. Tacrolimus drug costs are by far the largest single item in the total drug expenditure for patients with renal disease in the Stockholm area. Considerable reductions in drug costs could be achieved if generic tacrolimus were to be used. The aim of this quality assurance study was to evaluate whether a switch from Prograf® to generic tacrolimus (Tacrolimus Sandoz®) could be safely performed in renal transplant patients. It further aimed to investigate changes of renal function (measured in estimated glomerular filtration rate, eGFR), need for dose changes and to calculate potential drug cost savings as a result of the conversion. Methods We planned to recruit at least 50 patients. Plasma creatinine levels and trough concentrations of tacrolimus were collected from patients with renal transplants at three occasions during treatment with Prograf® and three times after conversion to Tacrolimus Sandoz®. The eGFR was calculated before and after the conversion. Results Sixty-three of 67 enrolled patients (69% males, age 28–80 years) are included in this analysis. The ratio of mean trough concentrations of tacrolimus after comparison with before conversion was 1.02 (90% confidence interval 0.95–1.09). Fourteen patients experienced a change in tacrolimus levels >20% compared with baseline, no patients changed >20% in eGFR. The drug cost saving per daily dose was 33.40 SEK (∼€3.60, −23%). Conclusions Stable kidney transplant patients treated with Prograf® can be converted to Tacrolimus Sandoz® if trough concentrations of tacrolimus and plasma creatinine levels are closely monitored. The conversion brought savings, despite costs for extra monitoring. PMID:24944783

Application of Gene Expression Trajectories Initiated from ErbB Receptor Activation Highlights the Dynamics of Divergent Promoter Usage.

PubMed

Carbajo, Daniel; Magi, Shigeyuki; Itoh, Masayoshi; Kawaji, Hideya; Lassmann, Timo; Arner, Erik; Forrest, Alistair R R; Carninci, Piero; Hayashizaki, Yoshihide; Daub, Carsten O; Okada-Hatakeyama, Mariko; Mar, Jessica C

2015-01-01

Understanding how cells use complex transcriptional programs to alter their fate in response to specific stimuli is an important question in biology. For the MCF-7 human breast cancer cell line, we applied gene expression trajectory models to identify the genes involved in driving cell fate transitions. We modified trajectory models to account for the scenario where cells were exposed to different stimuli, in this case epidermal growth factor and heregulin, to arrive at different cell fates, i.e. proliferation and differentiation respectively. Using genome-wide CAGE time series data collected from the FANTOM5 consortium, we identified the sets of promoters that were involved in the transition of MCF-7 cells to their specific fates versus those with expression changes that were generic to both stimuli. Of the 1,552 promoters identified, 1,091 had stimulus-specific expression while 461 promoters had generic expression profiles over the time course surveyed. Many of these stimulus-specific promoters mapped to key regulators of the ERK (extracellular signal-regulated kinases) signaling pathway such as FHL2 (four and a half LIM domains 2). We observed that in general, generic promoters peaked in their expression early on in the time course, while stimulus-specific promoters tended to show activation of their expression at a later stage. The genes that mapped to stimulus-specific promoters were enriched for pathways that control focal adhesion, p53 signaling and MAPK signaling while generic promoters were enriched for cell death, transcription and the cell cycle. We identified 162 genes that were controlled by an alternative promoter during the time course where a subset of 37 genes had separate promoters that were classified as stimulus-specific and generic. The results of our study highlighted the degree of complexity involved in regulating a cell fate transition where multiple promoters mapping to the same gene can demonstrate quite divergent expression profiles.

Application of process mapping to understand integration of high risk medicine care bundles within community pharmacy practice.

PubMed

Weir, Natalie M; Newham, Rosemary; Corcoran, Emma D; Ali Atallah Al-Gethami, Ashwag; Mohammed Abd Alridha, Ali; Bowie, Paul; Watson, Anne; Bennie, Marion

2017-11-21

The Scottish Patient Safety Programme - Pharmacy in Primary Care collaborative is a quality improvement initiative adopting the Institute of Healthcare Improvement Breakthrough Series collaborative approach. The programme developed and piloted High Risk Medicine (HRM) Care Bundles (CB), focused on warfarin and non-steroidal anti-inflammatories (NSAIDs), within 27 community pharmacies over 4 NHS Regions. Each CB involves clinical assessment and patient education, although the CB content varies between regions. To support national implementation, this study aims to understand how the pilot pharmacies integrated the HRM CBs into routine practice to inform the development of a generic HRM CB process map. Regional process maps were developed in 4 pharmacies through simulation of the CB process, staff interviews and documentation of resources. Commonalities were collated to develop a process map for each HRM, which were used to explore variation at a national event. A single, generic process map was developed which underwent validation by case study testing. The findings allowed development of a generic process map applicable to warfarin and NSAID CB implementation. Five steps were identified as required for successful CB delivery: patient identification; clinical assessment; pharmacy CB prompt; CB delivery; and documentation. The generic HRM CB process map encompasses the staff and patients' journey and the CB's integration into routine community pharmacy practice. Pharmacist involvement was required only for clinical assessment, indicating suitability for whole-team involvement. Understanding CB integration into routine practice has positive implications for successful implementation. The generic process map can be used to develop targeted resources, and/or be disseminated to facilitate CB delivery and foster whole team involvement. Similar methods could be utilised within other settings, to allow those developing novel services to distil the key processes and consider their integration within routine workflows to effect maximal, efficient implementation and benefit to patient care. Copyright © 2017 Elsevier Inc. All rights reserved.

Generic and scientific constraints involving geoethics and geoeducation in planetary geosciences

NASA Astrophysics Data System (ADS)

Martínez-Frías, Jesús

2013-04-01

Geoscience education is a key factor in the academic, scientific and professional progress of any modern society. Geoethics is an interdisciplinary field, which involves Earth and Planetary Sciences as well as applied ethics, regarding the study of the abiotic world. These coss-cutting interactions linking scientific, societal and cultural aspects, consider our planet, in its modern approach, as a system and as a model. This new perspective is extremely important in the context of geoducation in planetary geosciences. In addition, Earth, our home planet, is the only planet in our solar system known to harbor life. This also makes it crucial to develop any scientific strategy and methodological technique (e.g. Raman spectroscopy) of searching for extraterrestrial life. In this context, it has been recently proposed [1-3] that the incorporation of the geoethical and geodiversity issues in planetary geology and astrobiology studies would enrich their methodological and conceptual character (mainly but not only in relation to planetary protection). Modern geoscience education must take into account that, in order to understand the origin and evolution of our planet, we need to be aware that the Earth is open to space, and that the study of meteorites, asteroids, the Moon and Mars is also essential for this purpose (Earth analogs are also unique sites to define planetary guidelines). Generic and scientific constraints involving geoethics and geoeducation should be incorporated into the teaching of all fundamental knowledge and skills for students and teachers. References: [1] Martinez-Frias, J. et al. (2009) 9th European Workshop on Astrobiology, EANA 09, 12-14 October 2009, Brussels, Belgiam. [2] Martinez-Frias, J., et al. (2010) 38th COSPAR Scientific Assembly. Protecting the Lunar and Martian Environments for Scientific Research, Bremen, Germany, 18-25 July. [3] Walsh et al. (2012) 43rd Lunar and Planetary Science Conference, 1910.pdf

Self-Management and Self-Management Support Outcomes: A Systematic Review and Mixed Research Synthesis of Stakeholder Views.

PubMed

Boger, Emma; Ellis, Jaimie; Latter, Sue; Foster, Claire; Kennedy, Anne; Jones, Fiona; Fenerty, Vicky; Kellar, Ian; Demain, Sara

2015-01-01

Self-management has received growing attention as an effective approach for long-term condition management. Little is known about which outcomes of supported self-management are valued by patients, their families, health professionals and those who commission self-management services. This study systematically reviewed published empirical evidence in accordance with PRISMA guidelines to determine the outcomes of self-management valued by these key stakeholder groups, using three prominent exemplar conditions: colorectal cancer, diabetes and stroke. To systematically review the literature to identify which generic outcomes of self-management have been targeted and are considered important using three exemplar conditions (colorectal cancer, diabetes and stroke), which collectively have a range of features that are likely to be representative of generic self-management issues. Systematic searching of nine electronic databases was conducted in addition to hand searches of review articles. Abstracts were identified against inclusion criteria and appraised independently by two reviewers, using a critical appraisal tool. Synthesis of findings was conducted using mixed research synthesis. Over 20,536 abstracts were screened. 41 studies which met the review criteria were fully retrieved and appraised. The majority of evidence related to diabetes. Few studies directly focussed on stakeholders' views concerning desired self-management outcomes; the majority of evidence was derived from studies focusing upon the experience of self-management. The views of health care commissioners were absent from the literature. We identified that self-management outcomes embrace a range of indicators, from knowledge, skills, and bio-psychosocial markers of health through to positive social networks. Patients', families', health professionals' and commissioners' views regarding which outcomes of self-management are important have not been clearly elicited. The extent to which bio-psychosocial indicators relate to successful self-management from the perspectives of all groups of stakeholders is unknown. Further investigation regarding which self-management outcomes are considered important by all stakeholders is necessary to guide the commissioning and design of future self-management services.

Developing a policy game intervention to enhance collaboration in public health policymaking in three European countries.

PubMed

Spitters, H P E M; van Oers, J A M; Sandu, P; Lau, C J; Quanjel, M; Dulf, D; Chereches, R; van de Goor, L A M

2017-12-19

One of the key elements to enhance the uptake of evidence in public health policies is stimulating cross-sector collaboration. An intervention stimulating collaboration is a policy game. The aim of this study was to describe the design and methods of the development process of the policy game ‘In2Action’ within a real-life setting of public health policymaking networks in the Netherlands, Denmark and Romania. The development of the policy game intervention consisted of three phases, pre intervention, designing the game intervention and tailoring the intervention. In2Action was developed as a role-play game of one day, with main focus to develop in collaboration a cross-sector implementation plan based on the approved strategic local public health policy. This study introduced an innovative intervention for public health policymaking. It described the design and development of the generic frame of the In2Action game focusing on enhancing collaboration in local public health policymaking networks. By keeping the game generic, it became suitable for each of the three country cases with only minor changes. The generic frame of the game is expected to be generalizable for other European countries to stimulate interaction and collaboration in the policy process.

Framing access to medicines in developing countries: an analysis of media coverage of Canada's Access to Medicines Regime.

PubMed

Esmail, Laura C; Phillips, Kaye; Kuek, Victoria; Cosio, Andrea Perez; Kohler, Jillian Clare

2010-01-04

In September 2003, the Canadian government committed to developing legislation that would facilitate greater access to affordable medicines for developing countries. Over the course of eight months, the legislation, now known as Canada's Access to Medicines Regime (CAMR), went through a controversial policy development process and the newspaper media was one of the major venues in which the policy debates took place. The purpose of this study was to examine how the media framed CAMR to determine how policy goals were conceptualized, which stakeholder interests controlled the public debate and how these variables related to the public policy process. We conducted a qualitative content analysis of newspaper coverage of the CAMR policy and implementation process from 2003-2008. The primary theoretical framework for this study was framing theory. A total of 90 articles from 11 Canadian newspapers were selected for inclusion in our analysis. A team of four researchers coded the articles for themes relating to access to medicines and which stakeholders' voice figured more prominently on each issue. Stakeholders examined included: the research-based industry, the generic industry, civil society, the Canadian government, and developing country representatives. The most frequently mentioned themes across all documents were the issues of drug affordability, intellectual property, trade agreements and obligations, and development. Issues such as human rights, pharmaceutical innovation, and economic competitiveness got little media representation. Civil society dominated the media contents, followed far behind by the Canadian government, the research-based and generic pharmaceutical industries. Developing country representatives were hardly represented in the media. Media framing obscured the discussion of some of the underlying policy goals in this case and failed to highlight issues which are now significant barriers to the use of the legislation. Using the media to engage the public in more in-depth exploration of the policy issues at stake may contribute to a more informed policy development process. The media can be an effective channel for those stakeholders with a weaker voice in policy deliberations to raise public attention to particular issues; however, the political and institutional context must be taken into account as it may outweigh media framing effects.

Clinical review: impact of statin substitution policies on patient outcomes.

PubMed

Atar, Dan; Carmena, Rafael; Clemmensen, Peter; K-Laflamme, Annik; Wassmann, Sven; Lansberg, Peter; Hobbs, Richard

2009-01-01

The increasing awareness of cost issues in health care has led to the increasing use of policy-driven substitution of branded for generic medications, particularly relative to statin treatment for cardiovascular diseases. While there are potential short-term health care savings, the consequences for primary care are under-researched. Our objective was to review data on intensive statin therapy and generic substitution in patients at high cardiovascular risk. Current treatment guidelines for the prevention of cardiovascular disease are consistent in their recommendations regarding statin therapy and treatment targets. Clinical trials demonstrate that to reduce cardiovascular events, a statin is more effective than placebo, intensive statin therapy is more effective than moderate statin therapy in patients with established coronary disease, and in patients receiving intensive statin therapy the lowest risk is associated with the lowest low-density lipoprotein levels. However, in clinical practice, patients at high cardiovascular risk are prone to be undertreated. Observational studies suggest that mandatory statin substitution may increase the gap between achieved and recommended therapeutic targets. Substitution of generic statins may be cost-saving, particularly at the primary prevention level. However, statin substitution policies have not been adequately studied on a population level. Data raise concern that mandated statin substitution may lead to unfavourable treatment choices at the level of the individual high-risk patient.

Pharmaceutical pricing: an empirical study of market competition in Chinese hospitals.

PubMed

Wu, Jing; Xu, Judy; Liu, Gordon; Wu, Jiuhong

2014-03-01

High pharmaceutical prices and over-prescribing of high-priced pharmaceuticals in Chinese hospitals has long been criticized. Although policy makers have tried to address these issues, they have not yet found an effective balance between government regulation and market forces. Our objective was to explore the impact of market competition on pharmaceutical pricing under Chinese government regulation. Data from 11 public tertiary hospitals in three cities in China from 2002 to 2005 were used to explore the effect of generic and therapeutic competition on prices of antibiotics and cardiovascular products. A quasi-hedonic regression model was employed to estimate the impact of competition. The inputs to our model were specific attributes of the products and manufacturers, with the exception of competition variables. Our results suggest that pharmaceutical prices are inversely related to the number of generic and therapeutic competitors, but positively related to the number of therapeutic classes. In addition, the product prices of leading local manufacturers are not only significantly lower than those of global manufacturers, but are also lower than their non-leading counterparts when other product attributes are controlled for. Under the highly price-regulated market in China, competition from generic and therapeutic competitors did decrease pharmaceutical prices. Further research is needed to explore whether this competition increases consumer welfare in China's healthcare setting.

Education Studies: Issues & Critical Perspectives

ERIC Educational Resources Information Center

Kassem, Derek; Mufti, Emmanuel; Robinson, John

2006-01-01

This major text for Education Studies students provides a critical account of key issues in education today. The text features: (1) A critical analysis of key issues in Education Studies to encourage students' thinking about education in the broadest terms; (2) Themed sections with introductions to link the issues discussed in each chapter; (3)…

Hydrogeology and management of freshwater lenses on atoll islands: Review of current knowledge and research needs

NASA Astrophysics Data System (ADS)

Werner, Adrian D.; Sharp, Hannah K.; Galvis, Sandra C.; Post, Vincent E. A.; Sinclair, Peter

2017-08-01

On atoll islands, fresh groundwater occurs as a buoyant lens-shaped body surrounded by saltwater derived from the sea, forming the main freshwater source for many island communities. A review of the state of knowledge of atoll island groundwater is overdue given their susceptibility to adverse impacts, and the task to address water access and sanitation issues within the United Nations' Sustainable Development Goals framework before the year 2030. In this article, we review available literature to summarise the key processes, investigation techniques and management approaches of atoll island groundwater systems. Over fifty years of investigation has led to important advancements in the understanding of atoll hydrogeology, but a paucity of hydrogeological data persists on all but a small number of atoll islands. We find that the combined effects of buoyancy forces, complex geology, tides, episodic ocean events, strong climatic variability and human impacts create highly dynamic fresh groundwater lenses. Methods used to quantify freshwater availability range from simple empirical relationships to three-dimensional density-dependent models. Generic atoll island numerical models have proven popular in trying to unravel the individual factors controlling fresh groundwater lens behaviour. Major challenges face the inhabitants and custodians of atoll island aquifers, with rising anthropogenic stresses compounded by the threats of climate variability and change, sea-level rise, and some atolls already extracting freshwater at or above sustainability limits. We find that the study of atoll groundwater systems remains a critical area for further research effort to address persistent knowledge gaps, which lead to high uncertainties in water security issues for both island residents and surrounding environs.

Generic process design and control strategies used to develop a dynamic model and training software for an IGCC plant with CO2 sequestration

DOE Office of Scientific and Technical Information (OSTI.GOV)

Provost, G.; Stone, H.; McClintock, M.

2008-01-01

To meet the growing demand for education and experience with the analysis, operation, and control of commercial-scale Integrated Gasification Combined Cycle (IGCC) plants, the Department of Energy’s (DOE) National Energy Technology Laboratory (NETL) is leading a collaborative R&D project with participants from government, academia, and industry. One of the goals of this project is to develop a generic, full-scope, real-time generic IGCC dynamic plant simulator for use in establishing a world-class research and training center, as well as to promote and demonstrate the technology to power industry personnel. The NETL IGCC dynamic plant simulator will combine for the first timemore » a process/gasification simulator and a power/combined-cycle simulator together in a single dynamic simulation framework for use in training applications as well as engineering studies. As envisioned, the simulator will have the following features and capabilities: A high-fidelity, real-time, dynamic model of process-side (gasification and gas cleaning with CO2 capture) and power-block-side (combined cycle) for a generic IGCC plant fueled by coal and/or petroleum coke Full-scope training simulator capabilities including startup, shutdown, load following and shedding, response to fuel and ambient condition variations, control strategy analysis (turbine vs. gasifier lead, etc.), representative malfunctions/trips, alarms, scenarios, trending, snapshots, data historian, and trainee performance monitoring The ability to enhance and modify the plant model to facilitate studies of changes in plant configuration and equipment and to support future R&D efforts To support this effort, process descriptions and control strategies were developed for key sections of the plant as part of the detailed functional specification, which will form the basis of the simulator development. These plant sections include: Slurry Preparation Air Separation Unit Gasifiers Syngas Scrubbers Shift Reactors Gas Cooling, Medium Pressure (MP) and Low Pressure (LP) Steam Generation, and Knockout Sour Water Stripper Mercury Removal Selexol™ Acid Gas Removal System CO2 Compression Syngas Reheat and Expansion Claus Plant Hydrogenation Reactor and Gas Cooler Combustion Turbine (CT)-Generator Assemblies Heat Recovery Steam Generators (HRSGs) and Steam Turbine (ST)-Generator In this paper, process descriptions, control strategies, and Process & Instrumentation Diagram (P&ID) drawings for key sections of the generic IGCC plant are presented, along with discussions of some of the operating procedures and representative faults that the simulator will cover. Some of the intended future applications for the simulator are discussed, including plant operation and control demonstrations as well as education and training services such as IGCC familiarization courses.« less

Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

PubMed

Hansen, R A; Qian, J; Berg, R L; Linneman, J G; Seoane-Vazquez, E; Dutcher, S; Raofi, S; Page, C D; Peissig, P L

2018-02-01

Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999 and 2014, 5,234 unique patients were on brand drugs prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12 months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department (ED) visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparators. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Patient empowerment: The need to consider it as a measurable patient-reported outcome for chronic conditions

PubMed Central

2012-01-01

Background Health policy in the UK and elsewhere is prioritising patient empowerment and patient evaluations of healthcare. Patient reported outcome measures now take centre-stage in implementing strategies to increase patient empowerment. This article argues for consideration of patient empowerment itself as a directly measurable patient reported outcome for chronic conditions, highlights some issues in adopting this approach, and outlines a research agenda to enable healthcare evaluation on the basis of patient empowerment. Discussion Patient empowerment is not a well-defined construct. A range of condition-specific and generic patient empowerment questionnaires have been developed; each captures a different construct e.g. personal control, self-efficacy/self-mastery, and each is informed by a different implicit or explicit theoretical framework. This makes it currently problematic to conduct comparative evaluations of healthcare services on the basis of patient empowerment. A case study (clinical genetics) is used to (1) illustrate that patient empowerment can be a valued healthcare outcome, even if patients do not obtain health status benefits, (2) provide a rationale for conducting work necessary to tighten up the patient empowerment construct (3) provide an exemplar to inform design of interventions to increase patient empowerment in chronic disease. Such initiatives could be evaluated on the basis of measurable changes in patient empowerment, if the construct were properly operationalised as a patient reported outcome measure. To facilitate this, research is needed to develop an appropriate and widely applicable generic theoretical framework of patient empowerment to inform (re)development of a generic measure. This research should include developing consensus between patients, clinicians and policymakers about the content and boundaries of the construct before operationalisation. This article also considers a number of issues for society and for healthcare providers raised by adopting the patient empowerment paradigm. Summary Healthcare policy is driving the need to consider patient empowerment as a measurable patient outcome from healthcare services. Research is needed to (1) tighten up the construct (2) develop consensus about what is important to include (3) (re)develop a generic measure of patient empowerment for use in evaluating healthcare (4) understand if/how people make trade-offs between empowerment and gain in health status. PMID:22694747

Strategies of Educational Decentralization: Key Questions and Core Issues.

ERIC Educational Resources Information Center

Hanson, E. Mark

1998-01-01

Explains key issues and forces that shape organization and management strategies of educational decentralization, using examples from Colombia, Venezuela, Argentina, Nicaragua, and Spain. Core decentralization issues include national and regional goals, planning, political stress, resource distribution, infrastructure development, and job…

A synoptic review of the genus Thaumaspis Bolívar (Orthoptera, Tettigoniidae, Meconematinae) with the description of a new genus and four new species.

PubMed

Wang, Hanqiang; Liu, Xianwei; Li, Kai

2014-01-01

Two new species of the new genus Athaumaspisgen. n., Athaumaspisminutussp. n. and Athaumaspistibetanussp. n. from Vietnam and China are described. The subgenus Pseudothaumaspis of Thaumaspis is elevated to generic status and another two new species Pseudothaumaspisbispinosussp. n. and Pseudothaumaspisfurcocercussp. n. are described, the remaining species of Thaumaspis are reviewed and keyed with the four new species.

Review of the genus Neotetricodes Zhang et Chen (Hemiptera: Fulgoromorpha: Issidae) with description of two new species.

PubMed

Chang, Zhi-Min; Yang, Lin; Zhang, Zheng-Guang; Chen, Xiang-Sheng

2015-12-11

Two new species of the issid genus Neotetricodes Zhang et Chen (Hemiptera: Fulgoromorpha: Issidae): Neotetricodes longispinus Chang et Chen sp. nov. (China: Yunnan) and Neotetricodes xiphoideus Chang et Chen sp. nov. (China: Yunnan) are described and illustrated. The generic characteristic is redefined. A checklist and key to the species of the genus are provided. The female genitalia of the genus are firstly described.

Optimization design and laser damage threshold analysis of pulse compression multilayer dielectric gratings

NASA Astrophysics Data System (ADS)

Fan, Shuwei; Bai, Liang; Chen, Nana

2016-08-01

As one of the key elements of high-power laser systems, the pulse compression multilayer dielectric grating is required for broader band, higher diffraction efficiency and higher damage threshold. In this paper, the multilayer dielectric film and the multilayer dielectric gratings(MDG) were designed by eigen matrix and optimized with the help of generic algorithm and rigorous coupled wave method. The reflectivity was close to 100% and the bandwith were over 250nm, twice compared to the unoptimized film structure. The simulation software of standing wave field distribution within MDG was developed and the electric field of the MDG was calculated. And the key parameters which affected the electric field distribution were also studied.

Intelligent multi-sensor integrations

NASA Technical Reports Server (NTRS)

Volz, Richard A.; Jain, Ramesh; Weymouth, Terry

1989-01-01

Growth in the intelligence of space systems requires the use and integration of data from multiple sensors. Generic tools are being developed for extracting and integrating information obtained from multiple sources. The full spectrum is addressed for issues ranging from data acquisition, to characterization of sensor data, to adaptive systems for utilizing the data. In particular, there are three major aspects to the project, multisensor processing, an adaptive approach to object recognition, and distributed sensor system integration.

Ask the experts: the challenges and benefits of flow chemistry to optimize drug development.

PubMed

Anderson, Neal; Gernaey, Krist V; Jamison, Timothy F; Kircher, Manfred; Wiles, Charlotte; Leadbeater, Nicholas E; Sandford, Graham; Richardson, Paul

2012-09-01

Against a backdrop of a struggling economic and regulatory climate, pharmaceutical companies have recently been forced to develop new ways to provide more efficient technology to meet the demands of a competitive drug industry. This issue, coupled with an increase in patent legislation and a rising generics market, makes these themes common issues in the growth of drug development. As a consequence, the importance of process chemistry and scale-up has never been more under the spotlight. Future Medicinal Chemistry wishes to share the thoughts and opinions of a variety of experts from this field, discussing issues concerning the use of flow chemistry to optimize drug development, the potential regulatory and environmental challenges faced with this, and whether the academic and industrial sectors could benefit from a more harmonized system relevant to process chemistry.

Comparison of generic-to-brand switchback patterns for generic and authorized generic drugs

PubMed Central

Hansen, Richard A.; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K.; Raofi, Saeid; Page, C. David; Peissig, Peggy

2018-01-01

Background While generic drugs are therapeutically equivalent to brand drugs, some patients and healthcare providers remain uncertain about whether they produce identical outcomes. Authorized generics, which are identical in formulation to corresponding brand drugs but marketed as a generic, provide a unique post-marketing opportunity to study whether utilization patterns are influenced by perceptions of generic drugs. Objectives To compare generic-to-brand switchback rates between generics and authorized generics. Methods A retrospective cohort study was conducted using claims and electronic health records data from a regional U.S. healthcare system. Ten drugs with authorized generics and generics marketed between 1999 and 2014 were evaluated. Eligible adult patients received a brand drug during the 6 months preceding generic entry, and then switched to a generic or authorized generic. Patients in this cohort were followed for up to 30 months from the index switch date to evaluate occurrence of generic-to-brand switchbacks. Switchback rates were compared between patients on authorized generics versus generics using Kaplan-Meier curves and Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson comorbidity score, pre-index drug use characteristics, and pre-index healthcare utilization. Results Among 5,542 unique patients that switched from brand-to-generic or brand-to-authorized generic, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for authorized generics compared with generics (HR=0.86; 95% CI 0.65-1.15). The likelihood of switchback was higher for alendronate (HR=1.64; 95% CI 1.20-2.23) and simvastatin (HR=1.81; 95% CI 1.30-2.54) and lower for amlodipine (HR=0.27; 95% CI 0.17-0.42) compared with other drugs in the cohort. Conclusions Overall switchback rates were similar between authorized generic and generic drug users, indirectly supporting similar efficacy and tolerability profiles for brand and generic drugs. Reasons for differences in switchback rates among specific products need to be further explored. PMID:28152215

Determinants of branded prescription medicine prices in OECD countries.

PubMed

Kanavos, Panos G; Vandoros, Sotiris

2011-07-01

This paper investigates the determinants of the prices of branded prescription medicines across different regulatory settings and health care systems, taking into account their launch date, patent status, market dynamics and the regulatory context in which they diffuse. By using volume-weighted price indices, this paper analyzes price levels for a basket of prescription medicines and their differences in 15 OECD countries, including the United States and key European countries, the impact of distribution margins and generic entry on public prices and to what extent innovation, by means of introducing newer classes of medicines, contributes to price formation across countries. In doing so, the paper seeks to understand the factors that contribute to the existing differences in prices across countries, whether at an ex-factory or a retail level. The evidence shows that retail prices for branded prescription medicines in the United States are higher than those in key European and other OECD countries, but not as high as widely thought. Large differences in prices are mainly observed at an ex-factory level, but these are not the prices that consumers and payers pay. Cross-country differences in retail prices are actually not as high as expected and, when controlling for exchange rates, these differences can be even smaller. Product age has a significant effect on prices in all settings after having controlled for other factors. Price convergence is observed across countries for newer prescription medicines compared with older medicines. There is no evidence that originator brand prices fall after generic entry in the United States, a phenomenon known as the 'generics paradox'. Finally, distribution and taxes are important determinants of retail prices in several of the study countries. To the extent that remuneration of the distribution chain and taxation are directly and proportionately linked to product prices this is likely to persist over time.

Economic Impacts of the Generic Drug User Fee Act Fee Structure.

PubMed

Dong, Ke; Boehm, Garth; Zheng, Qiang

2017-06-01

A Food and Drug Administration (FDA) Generic Drug User system, Generic Drug User Fee Amendment of 2012 (GDUFA), started October 1, 2012, and has been in place for over 3 years. There is controversy about the GDUFA fee structure but no analysis of GDUFA data that we could find. To look at the economic impact of the GDUFA fee structure. We compared the structure of GDUFA with that of other FDA Human Drug User fees. We then, using FDA-published information, analyzed where GDUFA facility and Drug Master File fees are coming from. We used the Orange Book to identify the sponsors of all approved Abbreviated New Drug Applications (ANDAs) and the S&P Capital IQ database to find the ultimate parent companies of sponsors of approved ANDAs. The key differences between the previous structure for Human Drug User fees and the GDUFA are as follows: GDUFA has no approved product fee and no first-time or small business fee exemptions and GDUFA charges facility fees from the time of filing and charges a foreign facility levy. Most GDUFA fees are paid by or on behalf of foreign entities. The top 10 companies hold nearly 50% of all approved ANDAs but pay about 14% of GDUFA facility fees. We conclude that the regressive nature of the GDUFA fee structure penalizes small, new, and foreign firms while benefiting the large established firms. A progressive fee structure in line with other human drug user fees is needed to ensure a healthy generic drug industry. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Testing of complementarity of PDA and MS detectors using chromatographic fingerprinting of genuine and counterfeit samples containing sildenafil citrate.

PubMed

Custers, Deborah; Krakowska, Barbara; De Beer, Jacques O; Courselle, Patricia; Daszykowski, Michal; Apers, Sandra; Deconinck, Eric

2016-02-01

Counterfeit medicines are a global threat to public health. High amounts enter the European market, which is why characterization of these products is a very important issue. In this study, a high-performance liquid chromatography-photodiode array (HPLC-PDA) and high-performance liquid chromatography-mass spectrometry (HPLC-MS) method were developed for the analysis of genuine Viagra®, generic products of Viagra®, and counterfeit samples in order to obtain different types of fingerprints. These data were included in the chemometric data analysis, aiming to test whether PDA and MS are complementary detection techniques. The MS data comprise both MS1 and MS2 fingerprints; the PDA data consist of fingerprints measured at three different wavelengths, i.e., 254, 270, and 290 nm, and all possible combinations of these wavelengths. First, it was verified if both groups of fingerprints can discriminate between genuine, generic, and counterfeit medicines separately; next, it was studied if the obtained results could be ameliorated by combining both fingerprint types. This data analysis showed that MS1 does not provide suitable classification models since several genuines and generics are classified as counterfeits and vice versa. However, when analyzing the MS1_MS2 data in combination with partial least squares-discriminant analysis (PLS-DA), a perfect discrimination was obtained. When only using data measured at 254 nm, good classification models can be obtained by k nearest neighbors (kNN) and soft independent modelling of class analogy (SIMCA), which might be interesting for the characterization of counterfeit drugs in developing countries. However, in general, the combination of PDA and MS data (254 nm_MS1) is preferred due to less classification errors between the genuines/generics and counterfeits compared to PDA and MS data separately.

In search of standards to support circularity in product policies: A systematic approach.

PubMed

Tecchio, Paolo; McAlister, Catriona; Mathieux, Fabrice; Ardente, Fulvio

2017-12-01

The aspiration of a circular economy is to shift material flows toward a zero waste and pollution production system. The process of shifting to a circular economy has been initiated by the European Commission in their action plan for the circular economy. The EU Ecodesign Directive is a key policy in this transition. However, to date the focus of access to market requirements on products has primarily been upon energy efficiency. The absence of adequate metrics and standards has been a key barrier to the inclusion of resource efficiency requirements. This paper proposes a framework to boost sustainable engineering and resource use by systematically identifying standardization needs and features. Standards can then support the setting of appropriate material efficiency requirements in EU product policy. Three high-level policy goals concerning material efficiency of products were identified: embodied impact reduction, lifetime extension and residual waste reduction. Through a lifecycle perspective, a matrix of interactions among material efficiency topics (recycled content, re-used content, relevant material content, durability, upgradability, reparability, re-manufacturability, reusability, recyclability, recoverability, relevant material separability) and policy goals was created. The framework was tested on case studies for electronic displays and washing machines. For potential material efficiency requirements, specific standardization needs were identified, such as adequate metrics for performance measurements, reliable and repeatable tests, and calculation procedures. The proposed novel framework aims to provide a method by which to identify key material efficiency considerations within the policy context, and to map out the generic and product-specific standardisation needs to support ecodesign. Via such an approach, many different stakeholders (industry, academics, policy makers, non-governmental organizations etc.) can be involved in material efficiency standards and regulations. Requirements and standards concerning material efficiency would compel product manufacturers, but also help designers and interested parties in addressing the sustainable resource use issue.

Parameter estimation in large-scale systems biology models: a parallel and self-adaptive cooperative strategy.

PubMed

Penas, David R; González, Patricia; Egea, Jose A; Doallo, Ramón; Banga, Julio R

2017-01-21

The development of large-scale kinetic models is one of the current key issues in computational systems biology and bioinformatics. Here we consider the problem of parameter estimation in nonlinear dynamic models. Global optimization methods can be used to solve this type of problems but the associated computational cost is very large. Moreover, many of these methods need the tuning of a number of adjustable search parameters, requiring a number of initial exploratory runs and therefore further increasing the computation times. Here we present a novel parallel method, self-adaptive cooperative enhanced scatter search (saCeSS), to accelerate the solution of this class of problems. The method is based on the scatter search optimization metaheuristic and incorporates several key new mechanisms: (i) asynchronous cooperation between parallel processes, (ii) coarse and fine-grained parallelism, and (iii) self-tuning strategies. The performance and robustness of saCeSS is illustrated by solving a set of challenging parameter estimation problems, including medium and large-scale kinetic models of the bacterium E. coli, bakerés yeast S. cerevisiae, the vinegar fly D. melanogaster, Chinese Hamster Ovary cells, and a generic signal transduction network. The results consistently show that saCeSS is a robust and efficient method, allowing very significant reduction of computation times with respect to several previous state of the art methods (from days to minutes, in several cases) even when only a small number of processors is used. The new parallel cooperative method presented here allows the solution of medium and large scale parameter estimation problems in reasonable computation times and with small hardware requirements. Further, the method includes self-tuning mechanisms which facilitate its use by non-experts. We believe that this new method can play a key role in the development of large-scale and even whole-cell dynamic models.

The oribatid mite genus Macrogena (Acari, Oribatida, Ceratozetidae), with description of two new species from New Zealand

PubMed Central

Ermilov, Sergey G.; Minor, Maria A.

2015-01-01

Abstract Two new species of oribatid mites of the genus Macrogena (Oribatida, Ceratozetidae) are described from alpine soils of the South Island of New Zealand. Macrogena brevisensilla sp. n. and Macrogena abbreviata sp. n. differ from all species of this genus by the tridactylous legs and by the comparatively short interlamellar setae, respectively. New generic diagnosis and an identification key to the known species of Macrogena are provided. PMID:26085792

A Best Practices Model for Implementing Successful Electronic Disease Surveillance Systems: Insights from Peru and Around the Globe

DTIC Science & Technology

2013-06-03

associated Program design: Kenya . and written project with improved I) Generic model should be adaptable documentation. diagnosis or treatment. to local...potential for and threats to development through an unsustainable and 3) Gaps in evaluation in area of building sustainable to performance -based...implementation in developing countries by building a framework that will identify key elements in this process and serve as guidance to implementers. This study

Pathophysiology of chest trauma.

PubMed

Calhoon, J H; Trinkle, J K

1997-05-01

Recent information indicates that there is a complex cellular and molecular generic response to injury that can lead to multi-organ failure. For many years, basic physiology and biochemistry were considered to be the systemic mechanisms to injury, but now it is known that subcellular and molecular events are the keys to unlocking the secrets of the body's response to trauma. The interaction of the endothelial cell with neutrophils and platelets to produce cytokines, free radicals, and upregulating adhesion molecules is especially significant.

First record of Odontomesa Pagast from China, with description of the immature stages of O. ferringtoni Sæther (Diptera, Chironomidae, Prodiamesinae).

PubMed

Liu, Wenbin; Ferrington, Leonard C Jr; Wang, Xinhua

2016-06-28

The genus Odontomesa Pagast is newly recorded from China. Based on associated material collected from China and U.S.A, the immature stages of Odontomesa fulva (Kieffer) and Odontomesa ferringtoni Sæther are redescribed. Odontomesa sp. A Sæther is confirmed as conspecific with O. ferringtoni. The generic diagnosis of immature stages is emended. Keys to the known larvae and pupae of the genus are presented.

From Domain Specific Languages to DEVS Components: Application to Cognitive M&S

DTIC Science & Technology

2011-04-01

AND SUBTITLE From Domain Specific Languages to DEVS Components: Application to Cognitive M&S 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ...that is devoid of any DEVS and programming language constructs (Figure 4). The key idea being domain specialists need not delve in the DEVS world to...DSL. DSLs can be created using many available tools and technologies such as: Generic Modeling Environment (GME) [23], Xtext, Ruby, Scala and many

An understanding of modified release matrix tablets behavior during drug dissolution as the key for prediction of pharmaceutical product performance - case study of multimodal characterization of quetiapine fumarate tablets.

PubMed

Kulinowski, Piotr; Woyna-Orlewicz, Krzysztof; Rappen, Gerd-Martin; Haznar-Garbacz, Dorota; Węglarz, Władysław P; Dorożyński, Przemysław P

2015-04-30

Motivation for the study was the lack of dedicated and effective research and development (R&D) in vitro methods for oral, generic, modified release formulations. The purpose of the research was to assess multimodal in vitro methodology for further bioequivalence study risk minimization. Principal results of the study are as follows: (i) Pharmaceutically equivalent quetiapine fumarate extended release dosage form of Seroquel XR was developed using a quality by design/design of experiment (QbD/DoE) paradigm. (ii) The developed formulation was then compared with originator using X-ray microtomography, magnetic resonance imaging and texture analysis. Despite similarity in terms of compendial dissolution test, developed and original dosage forms differed in micro/meso structure and consequently in mechanical properties. (iii) These differences were found to be the key factors of failure of biorelevant dissolution test using the stress dissolution apparatus. Major conclusions are as follows: (i) Imaging methods allow to assess internal features of the hydrating extended release matrix and together with the stress dissolution test allow to rationalize the design of generic formulations at the in vitro level. (ii) Technological impact on formulation properties e.g., on pore formation in hydrating matrices cannot be overlooked when designing modified release dosage forms. Copyright © 2015 Elsevier B.V. All rights reserved.

Relative stability of DNA as a generic criterion for promoter prediction: whole genome annotation of microbial genomes with varying nucleotide base composition.

PubMed

Rangannan, Vetriselvi; Bansal, Manju

2009-12-01

The rapid increase in genome sequence information has necessitated the annotation of their functional elements, particularly those occurring in the non-coding regions, in the genomic context. Promoter region is the key regulatory region, which enables the gene to be transcribed or repressed, but it is difficult to determine experimentally. Hence an in silico identification of promoters is crucial in order to guide experimental work and to pin point the key region that controls the transcription initiation of a gene. In this analysis, we demonstrate that while the promoter regions are in general less stable than the flanking regions, their average free energy varies depending on the GC composition of the flanking genomic sequence. We have therefore obtained a set of free energy threshold values, for genomic DNA with varying GC content and used them as generic criteria for predicting promoter regions in several microbial genomes, using an in-house developed tool PromPredict. On applying it to predict promoter regions corresponding to the 1144 and 612 experimentally validated TSSs in E. coli (50.8% GC) and B. subtilis (43.5% GC) sensitivity of 99% and 95% and precision values of 58% and 60%, respectively, were achieved. For the limited data set of 81 TSSs available for M. tuberculosis (65.6% GC) a sensitivity of 100% and precision of 49% was obtained.

Coalition Building for Adult Literacy: Historical and Organizational Perspectives.

ERIC Educational Resources Information Center

Newman, Anabel P.; Lehman, Bernadette

Selected successful literacy coalitions were examined to identify key issues and trends in coalition building. The six key issues identified (focus and functions, funding, governance, membership, key figures, and evaluation) were used as a framework to review the early efforts, current activities, and future visions of literacy coalitions…

New Borns...Getting a Good Start.

ERIC Educational Resources Information Center

Huraux-Rendu, Christine; And Others

1991-01-01

This issue of Children in the Tropics analyzes key issues relating to protecting the health of newborn infants. Many of the suggestions offered concern rudimentary health care situations in developing countries. Key issues are addressed in four sections. The first section discusses the early care and first medical examination of infants born in…

Authorized generic drugs, price competition, and consumers' welfare.

PubMed

Berndt, Ernst R; Mortimer, Richard; Bhattacharjya, Ashoke; Parece, Andrew; Tuttle, Edward

2007-01-01

The growing frequency of authorized generics has important implications for the welfare of prescription drug consumers. Authorized generic entry could affect the timing of generic entry, brand-name and generic prices, and generic penetration. We reviewed 1999-2003 data and found that generic entry in the absence of short-run exclusivity restrictions benefits consumers through lower short-run prices. We suggest that these benefits likely also result from authorized generics. We posit that long-run prices and shares are likely essentially unaffected by authorized generics and that potential costs to consumers from any delayed generic entry are likely small.

Site Specific Probable Maximum Precipitation Estimates and Professional Judgement

NASA Astrophysics Data System (ADS)

Hayes, B. D.; Kao, S. C.; Kanney, J. F.; Quinlan, K. R.; DeNeale, S. T.

2015-12-01

State and federal regulatory authorities currently rely upon the US National Weather Service Hydrometeorological Reports (HMRs) to determine probable maximum precipitation (PMP) estimates (i.e., rainfall depths and durations) for estimating flooding hazards for relatively broad regions in the US. PMP estimates for the contributing watersheds upstream of vulnerable facilities are used to estimate riverine flooding hazards while site-specific estimates for small water sheds are appropriate for individual facilities such as nuclear power plants. The HMRs are often criticized due to their limitations on basin size, questionable applicability in regions affected by orographic effects, their lack of consist methods, and generally by their age. HMR-51 for generalized PMP estimates for the United States east of the 105th meridian, was published in 1978 and is sometimes perceived as overly conservative. The US Nuclear Regulatory Commission (NRC), is currently reviewing several flood hazard evaluation reports that rely on site specific PMP estimates that have been commercially developed. As such, NRC has recently investigated key areas of expert judgement via a generic audit and one in-depth site specific review as they relate to identifying and quantifying actual and potential storm moisture sources, determining storm transposition limits, and adjusting available moisture during storm transposition. Though much of the approach reviewed was considered a logical extension of HMRs, two key points of expert judgement stood out for further in-depth review. The first relates primarily to small storms and the use of a heuristic for storm representative dew point adjustment developed for the Electric Power Research Institute by North American Weather Consultants in 1993 in order to harmonize historic storms for which only 12 hour dew point data was available with more recent storms in a single database. The second issue relates to the use of climatological averages for spatially interpolating 100-year dew point values rather than a more gauge-based approach. Site specific reviews demonstrated that both issues had potential for lowering the PMP estimate significantly by affecting the in-place and transposed moisture maximization value and, in turn, the final controlling storm for a given basin size and PMP estimate.

Literature Survey for Issues in Naval Decision Support: Phase 2

DTIC Science & Technology

1999-01-01

human cognition, the specific goals of Soar ( Congdon & Laird, 1996, cited in Kalus et al., 1996) are to: • Work on a full range of tasks from routine...leadership, and communication (Weaver et al., 1995). 5.5.4.4 Team Performance Assessment Battery (TPAB) TP AB is a more generic scenario...permits multiple tasks, including monitoring tasks, to be imposed on teams to assess factors related to workload. Thus, TP AB is suitable for assessing

Exploration and Production of Hydrocarbon Resources in Coastal Alabama and Mississippi. Executive Summary.

DTIC Science & Technology

1984-11-01

r .-. u S FINAL GENERIC ENVIROMENTAL IMPACT SlAiLMENT .XPLORAYION AND PRODUCTION OF HYDROCARBON RESOU CES IN COASTAL AIABAMA AND MISSISSIPPI The...a service could potentially affect cultural resources in the area of development. Prior to issuing any project permit, conflicts on potential impacts...34 Air Emission. 6-34 Noise 6-34 Solid and Hazardous Waste 6-34 Socioe -conomic Characteristics 6-34 Navigation 6-34 xxiv TABLE OF CONTENTS (Continued

Space station structures and dynamics test program

NASA Technical Reports Server (NTRS)

Moore, Carleton J.; Townsend, John S.; Ivey, Edward W.

1987-01-01

The design, construction, and operation of a low-Earth orbit space station poses unique challenges for development and implementation of new technology. The technology arises from the special requirement that the station be built and constructed to function in a weightless environment, where static loads are minimal and secondary to system dynamics and control problems. One specific challenge confronting NASA is the development of a dynamics test program for: (1) defining space station design requirements, and (2) identifying the characterizing phenomena affecting the station's design and development. A general definition of the space station dynamic test program, as proposed by MSFC, forms the subject of this report. The test proposal is a comprehensive structural dynamics program to be launched in support of the space station. The test program will help to define the key issues and/or problems inherent to large space structure analysis, design, and testing. Development of a parametric data base and verification of the math models and analytical analysis tools necessary for engineering support of the station's design, construction, and operation provide the impetus for the dynamics test program. The philosophy is to integrate dynamics into the design phase through extensive ground testing and analytical ground simulations of generic systems, prototype elements, and subassemblies. On-orbit testing of the station will also be used to define its capability.

Palliative and end-of-life care for adults with advanced chronic obstructive pulmonary disease: a rapid review focusing on patient and family caregiver perspectives.

PubMed

Mathews, Gillian; Johnston, Bridget

2017-12-01

The aim of the review was to explore patient and family caregiver perspectives on key issues for ensuring quality of end-of-life care for people with chronic obstructive pulmonary disease (COPD). The growing evidence on the value of specialist palliative care services demonstrates significant improvements in treatments and provisions; however, much of the literature is generic in nature or centred on people with a cancer diagnosis. In this review, we examine the literature to ascertain the views and needs of patients and carers affected by advanced COPD, a highly debilitating condition that can have a profoundly negative impact on the quality of end-of-life experience. A total of 19 papers were included in the review. The main themes in the literature were Holistic Care, Illness Trajectory and Technology. Areas of unmet need emphasized across physical, psychosocial and spiritual domains were identified, particularly in relation to appropriate and timely conversations. Positive developments in the care and treatment of advanced COPD include the use of the STIOLTO Respimat inhaler, a brief educative and psychosocial intervention based on cognitive-behavioural therapy, and high-intensity exercise training. There is some evidence regarding the use of technology in end-stage COPD.

Large-scale organizational and managerial change in health care: a review of the literature.

PubMed

Ferlie, E

1997-07-01

This paper takes an overview of the organizational and managerial literature on recent large-scale change efforts within health care organizations. Such literature refers to issues of enhanced policy significance, as a succession of such changes has swept through health care, at an international level. Interpretive and case study method have been widely employed in this field. While the literature is emergent, key empirical concerns can be identified: (1) Changing roles and relationships, with the rise of management and the challenge to clinical domination; some argue that radical deprofessionalization now is evident, while others take a more nuanced view. (2) The impact of marketization, with health care becoming more of a commodity; various models of a health care 'quasi market' have been formulated. (3) Understanding the process of change in health care organizations, such as the development of a management of change literature. New theoretical frameworks have been developed, notably 'the reform cycle' as a way of understanding progressive cycles of organizational reform, the impact on health care of the rise of the new public management, and examining the demedicalization thesis through the more generic literature on professions. The paper concludes with a discussion of what this research base could contribute to policy-making.

The regulator's perspective: How should new therapies and follow-on products for MS be clinically evaluated in the future?

PubMed

Crommelin, Daan Ja; Broich, Karl; Holloway, Chris; Meesen, Bianca; Lizrova Preiningerova, Jana; Prugnaud, Jean-Louis; Silva-Lima, Beatriz

2016-08-01

Although there is still no cure for multiple sclerosis (MS), the introduction of several innovative drugs with modes of action different from that of the existing drug arsenal and the progress in monitoring disease progression by imaging and using biomarkers are currently causing a knowledge surge. This provides opportunities for improving patient disease management. New therapies are also under development and pose challenges to the regulatory bodies regarding the optimal design of clinical trials with more patient-focused clinical endpoints. Moreover, with the upcoming patent expiry of some of the key first-line MS treatments in Europe, regulatory bodies will also face the challenge of recommending marketing authorisation for generic and abridged versions based on appropriate requirements for demonstrating equality/similarity to the innovator's product. The goal of this article is to improve the understanding of the relevant guidance documents of the European Medicines Agency (EMA) on clinical investigation of medicinal products and to highlight the issues that the agency will need to clarify regarding follow-on products of first-line MS treatments. Today, it is clear that close collaboration between patients, healthcare professionals, regulatory bodies and industry is crucial for developing new safe and effective drugs, which satisfy the needs of MS patients. © The Author(s), 2016.

Surfactant-free Colloidal Particles with Specific Binding Affinity

PubMed Central

2017-01-01

Colloidal particles with specific binding affinity are essential for in vivo and in vitro biosensing, targeted drug delivery, and micrometer-scale self-assembly. Key to these techniques are surface functionalizations that provide high affinities to specific target molecules. For stabilization in physiological environments, current particle coating methods rely on adsorbed surfactants. However, spontaneous desorption of these surfactants typically has an undesirable influence on lipid membranes. To address this issue and create particles for targeting molecules in lipid membranes, we present here a surfactant-free coating method that combines high binding affinity with stability at physiological conditions. After activating charge-stabilized polystyrene microparticles with EDC/Sulfo-NHS, we first coat the particles with a specific protein and subsequently covalently attach a dense layer of poly(ethyelene) glycol. This polymer layer provides colloidal stability at physiological conditions as well as antiadhesive properties, while the protein coating provides the specific affinity to the targeted molecule. We show that NeutrAvidin-functionalized particles bind specifically to biotinylated membranes and that Concanavalin A-functionalized particles bind specifically to the glycocortex of Dictyostelium discoideum cells. The affinity of the particles changes with protein density, which can be tuned during the coating procedure. The generic and surfactant-free coating method reported here transfers the high affinity and specificity of a protein onto colloidal polystyrene microparticles. PMID:28847149

Active magnetic radiation shielding system analysis and key technologies.

PubMed

Washburn, S A; Blattnig, S R; Singleterry, R C; Westover, S C

2015-01-01

Many active magnetic shielding designs have been proposed in order to reduce the radiation exposure received by astronauts on long duration, deep space missions. While these designs are promising, they pose significant engineering challenges. This work presents a survey of the major systems required for such unconfined magnetic field design, allowing the identification of key technologies for future development. Basic mass calculations are developed for each system and are used to determine the resulting galactic cosmic radiation exposure for a generic solenoid design, using a range of magnetic field strength and thickness values, allowing some of the basic characteristics of such a design to be observed. This study focuses on a solenoid shaped, active magnetic shield design; however, many of the principles discussed are applicable regardless of the exact design configuration, particularly the key technologies cited. Copyright © 2015 The Committee on Space Research (COSPAR). All rights reserved.

The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine use

PubMed Central

Hassali, Mohamed Azmi; Alrasheedy, Alian A.; McLachlan, Andrew; Nguyen, Tuan Anh; AL-Tamimi, Saleh Karamah; Ibrahim, Mohamed Izham Mohamed; Aljadhey, Hisham

2013-01-01

Generic medicines are clinically interchangeable with original brand medicines and have the same quality, efficacy and safety profiles. They are, nevertheless, much cheaper in price. Thus, while providing the same therapeutic outcomes, generic medicines lead to substantial savings for healthcare systems. Therefore, the quality use of generic medicines is promoted in many countries. In this paper, we reviewed the role of generic medicines in healthcare systems and the experiences of promoting the use of generic medicines in eight selected countries, namely the United States (US), the United Kingdom (UK), Sweden, Finland, Australia, Japan, Malaysia and Thailand. The review showed that there are different main policies adopted to promote generic medicines such as generic substitution in the US, generic prescribing in the UK and mandatory generic substitution in Sweden and Finland. To effectively and successfully implement the main policy, different complementary policies and initiatives were necessarily introduced. Barriers to generic medicine use varied between countries from negative perceptions about generic medicines to lack of a coherent generic medicine policy, while facilitators included availability of information about generic medicines to both healthcare professionals and patients, brand interchangeability guidelines, regulations that support generic substitution by pharmacists, and incentives to both healthcare professionals and patients. PMID:25561861

What shapes research impact on policy? Understanding research uptake in sexual and reproductive health policy processes in resource poor contexts

PubMed Central

2011-01-01

Assessing the impact that research evidence has on policy is complex. It involves consideration of conceptual issues of what determines research impact and policy change. There are also a range of methodological issues relating to the question of attribution and the counter-factual. The dynamics of SRH, HIV and AIDS, like many policy arenas, are partly generic and partly issue- and context-specific. Against this background, this article reviews some of the main conceptualisations of research impact on policy, including generic determinants of research impact identified across a range of settings, as well as the specificities of SRH in particular. We find that there is scope for greater cross-fertilisation of concepts, models and experiences between public health researchers and political scientists working in international development and research impact evaluation. We identify aspects of the policy landscape and drivers of policy change commonly occurring across multiple sectors and studies to create a framework that researchers can use to examine the influences on research uptake in specific settings, in order to guide attempts to ensure uptake of their findings. This framework has the advantage that distinguishes between pre-existing factors influencing uptake and the ways in which researchers can actively influence the policy landscape and promote research uptake through their policy engagement actions and strategies. We apply this framework to examples from the case study papers in this supplement, with specific discussion about the dynamics of SRH policy processes in resource poor contexts. We conclude by highlighting the need for continued multi-sectoral work on understanding and measuring research uptake and for prospective approaches to receive greater attention from policy analysts. PMID:21679384

Routes to the past: neural substrates of direct and generative autobiographical memory retrieval.

PubMed

Addis, Donna Rose; Knapp, Katie; Roberts, Reece P; Schacter, Daniel L

2012-02-01

Models of autobiographical memory propose two routes to retrieval depending on cue specificity. When available cues are specific and personally-relevant, a memory can be directly accessed. However, when available cues are generic, one must engage a generative retrieval process to produce more specific cues to successfully access a relevant memory. The current study sought to characterize the neural bases of these retrieval processes. During functional magnetic resonance imaging (fMRI), participants were shown personally-relevant cues to elicit direct retrieval, or generic cues (nouns) to elicit generative retrieval. We used spatiotemporal partial least squares to characterize the spatial and temporal characteristics of the networks associated with direct and generative retrieval. Both retrieval tasks engaged regions comprising the autobiographical retrieval network, including hippocampus, and medial prefrontal and parietal cortices. However, some key neural differences emerged. Generative retrieval differentially recruited lateral prefrontal and temporal regions early on during the retrieval process, likely supporting the strategic search operations and initial recovery of generic autobiographical information. However, many regions were activated more strongly during direct versus generative retrieval, even when we time-locked the analysis to the successful recovery of events in both conditions. This result suggests that there may be fundamental differences between memories that are accessed directly and those that are recovered via the iterative search and retrieval process that characterizes generative retrieval. Copyright © 2011 Elsevier Inc. All rights reserved.

Routes to the past: Neural substrates of direct and generative autobiographical memory retrieval

PubMed Central

Addis, Donna Rose; Knapp, Katie; Roberts, Reece P.; Schacter, Daniel L.

2011-01-01

Models of autobiographical memory propose two routes to retrieval depending on cue specificity. When available cues are specific and personally-relevant, a memory can be directly accessed. However, when available cues are generic, one must engage a generative retrieval process to produce more specific cues to successfully access a relevant memory. The current study sought to characterize the neural bases of these retrieval processes. During functional magnetic resonance imaging (fMRI), participants were shown personally-relevant cues to elicit direct retrieval, or generic cues (nouns) to elicit generative retrieval. We used spatiotemporal partial least squares to characterize the spatial and temporal characteristics of the networks associated with direct and generative retrieval. Both retrieval tasks engaged regions comprising the autobiographical retrieval network, including hippocampus, and medial prefrontal and parietal cortices. However, some key neural differences emerged. Generative retrieval differentially recruited lateral prefrontal and temporal regions early on during the retrieval process, likely supporting the strategic search operations and initial recovery of generic autobiographical information. However, many regions were activated more strongly during direct versus generative retrieval, even when we time-locked the analysis to the successful recovery of events in both conditions. This result suggests that there may be fundamental differences between memories that are accessed directly and those that are recovered via the iterative search and retrieval process that characterizes generative retrieval. PMID:22001264

Estimating pesticide runoff in small streams.

PubMed

Schriever, Carola A; von der Ohe, Peter C; Liess, Matthias

2007-08-01

Surface runoff is one of the most important pathways for pesticides to enter surface waters. Mathematical models are employed to characterize its spatio-temporal variability within landscapes, but they must be simple owing to the limited availability and low resolution of data at this scale. This study aimed to validate a simplified spatially-explicit model that is developed for the regional scale to calculate the runoff potential (RP). The RP is a generic indicator of the magnitude of pesticide inputs into streams via runoff. The underlying runoff model considers key environmental factors affecting runoff (precipitation, topography, land use, and soil characteristics), but predicts losses of a generic substance instead of any one pesticide. We predicted and evaluated RP for 20 small streams. RP input data were extracted from governmental databases. Pesticide measurements from a triennial study were used for validation. Measured pesticide concentrations were standardized by the applied mass per catchment and the water solubility of the relevant compounds. The maximum standardized concentration per site and year (runoff loss, R(Loss)) provided a generalized measure of observed pesticide inputs into the streams. Average RP explained 75% (p<0.001) of the variance in R(Loss). Our results imply that the generic indicator can give an adequate estimate of runoff inputs into small streams, wherever data of similar resolution are available. Therefore, we suggest RP for a first quick and cost-effective location of potential runoff hot spots at the landscape level.

GOMMA: a component-based infrastructure for managing and analyzing life science ontologies and their evolution

PubMed Central

2011-01-01

Background Ontologies are increasingly used to structure and semantically describe entities of domains, such as genes and proteins in life sciences. Their increasing size and the high frequency of updates resulting in a large set of ontology versions necessitates efficient management and analysis of this data. Results We present GOMMA, a generic infrastructure for managing and analyzing life science ontologies and their evolution. GOMMA utilizes a generic repository to uniformly and efficiently manage ontology versions and different kinds of mappings. Furthermore, it provides components for ontology matching, and determining evolutionary ontology changes. These components are used by analysis tools, such as the Ontology Evolution Explorer (OnEX) and the detection of unstable ontology regions. We introduce the component-based infrastructure and show analysis results for selected components and life science applications. GOMMA is available at http://dbs.uni-leipzig.de/GOMMA. Conclusions GOMMA provides a comprehensive and scalable infrastructure to manage large life science ontologies and analyze their evolution. Key functions include a generic storage of ontology versions and mappings, support for ontology matching and determining ontology changes. The supported features for analyzing ontology changes are helpful to assess their impact on ontology-dependent applications such as for term enrichment. GOMMA complements OnEX by providing functionalities to manage various versions of mappings between two ontologies and allows combining different match approaches. PMID:21914205

Bioequivalence Between Generic and Branded Lamotrigine in People With Epilepsy: The EQUIGEN Randomized Clinical Trial.

PubMed

Berg, Michel; Welty, Timothy E; Gidal, Barry E; Diaz, Francisco J; Krebill, Ron; Szaflarski, Jerzy P; Dworetzky, Barbara A; Pollard, John R; Elder, Edmund J; Jiang, Wenlei; Jiang, Xiaohui; Switzer, Regina D; Privitera, Michael D

2017-08-01

Switching between generic antiepileptic drugs is a highly debated issue that affects both clinical care and overall health care costs. To evaluate the single-dose pharmacokinetic bioequivalence of 3 (1 branded and 2 generic drugs) on-market, immediate-release lamotrigine drug products. The Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy (EQUIGEN) single-dose study is a crossover, prospective, sequence-randomized, replicate pharmacokinetic study conducted at 5 US academic epilepsy centers. Fifty adults (≥18 years) with epilepsy who were taking concomitant antiepileptic drugs and not currently receiving lamotrigine were enrolled between July 18, 2013, and January 19, 2015. Every participant was randomly assigned to 1 of 3 equivalent sequences, each comprising 6 study periods, during which they had blood draws before and after medication administration. Forty-nine participants were included in intention-to-treat analyses. Participants received a single 25-mg dose of immediate-release lamotrigine at the start of each period, with the branded and the 2 most disparate generic products each studied twice. Lamotrigine was selected as the antiepileptic drug of interest because of its wide use, publications indicating problems with generic switches, and complaints to the US Food and Drug Administration regarding generic products. Both participants and study personnel were blinded to the specific generic products selected. The primary outcome was bioequivalence between products. Maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC) were compared, and average bioequivalence (ABE) was established if the 90% CIs of the ratios of the 2 products were within equivalence limits (80%-125%). Of the 50 randomized participants, 49 (98%) received all 3 lamotrigine products and completed at least 3 pharmacokinetic assessments and 46 (92%) completed all 6 pharmacokinetic assessments. Among the 49 participants, 28 (57%) were men and 21 (43%) were women, 42 (86%) self-identified as white, and 46 (16) years was the mean (SD) age. The 3 drug products were considered bioequivalent because the 90% CIs were within equivalence limits (lowest and highest CI limits for Cmax, 92.6% and 110.4%; for AUC0-96, 96.9% and 101.9%). Replicate testing demonstrated no significant differences in within-subject variability across the 3 products (likelihood ratios, χ22 for log-transformed variables: AUC0-96, 2.58; Cmax, 0.64; and AUC0-∞, 4.05; P ≥ .13) and that the 3 products were also bioequivalent according to scaled ABE and individual bioequivalence criteria with no subject × formulation interaction (Cmax, 0.00; AUC0-96, 0.54; and AUC0-∞, 0.36; P ≥ .76). This study provides evidence that the disparate lamotrigine products studied are bioequivalent when tested in people with epilepsy taking concomitant antiepileptic drugs. clinicaltrials.gov Identifier: NCT01733394.

Factors influencing community nursing roles and health service provision in rural areas: a review of literature.

PubMed

Barrett, Annette; Terry, Daniel R; Lê, Quynh; Hoang, Ha

2016-02-01

This review sought to better understand the issues and challenges experienced by community nurses working in rural areas and how these factors shape their role. Databases were searched to identify relevant studies, published between 1990 and 2015, that focussed on issues and challenges experienced by rural community nurses. Generic and grey literature relating to the subject was also searched. The search was systematically conducted multiple times to assure accuracy. A total of 14 articles met the inclusion criteria. This critical review identified common issues impacting community nursing and included role definition, organisational change, human resource, workplace and geographic challenges. Community nurses are flexible, autonomous, able to adapt care to the service delivery setting, and have a diversity of knowledge and skills. Considerably more research is essential to identify factors that impact rural community nursing practice. In addition, greater advocacy is required to develop the role.

Salt-gradient Solar Ponds: Summary of US Department of Energy Sponsored Research

NASA Technical Reports Server (NTRS)

French, R. L.; Johnson, D. H.; Jones, G. F.; Zangrando, F.

1984-01-01

The solar pond research program conducted by the United States Department of Energy was discontinued after 1983. This document summarizes the results of the program, reviews the state of the art, and identifies the remaining outstanding issues. Solar ponds is a generic term but, in the context of this report, the term solar pond refers specifically to saltgradient solar pond. Several small research solar ponds have been built and successfully tested. Procedures for filling the pond, maintaining the gradient, adjusting the zone boundaries, and extracting heat were developed. Theories and models were developed and verified. The major remaining unknowns or issues involve the physical behavior of large ponds; i.e., wind mixing of the surface, lateral range or reach of horizontally injected fluids, ground thermal losses, and gradient zone boundary erosion caused by pumping fluid for heat extraction. These issues cannot be scaled and must be studied in a large outdoor solar pond.

Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

DOE Office of Scientific and Technical Information (OSTI.GOV)

Szebeni, Janos, E-mail: jszebeni2@gmail.com; Storm, Gert

Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs.more » long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.« less

Relationships between healthcare and research records.

PubMed

Duwe, Helmut

2004-01-01

The ultimate end-point of healthcare and health-related life sciences, more or less as regulatory idea, is the prevention and cure of diseases, considering the fate of individual patients as well as the challenge of providing sufficient care for all. However, all undertakings stand under the "proviso of rightness of action". The movement of evidence-based medicine has triggered a renaissance of systematic self-assurance of best practise. The systematic utilization of healthcare records and research study recordings in an inter-linked manner provides a better enabling environment to improve evidence. Good e-health must contribute to accumulate inter-generation clinical experience. Qualified research should ensure methodological strictness via gold standards like controlled, randomised and masked trials. Building information systems for e-health as well as for e-science bears as a special focus the mutual cross-fertilization of these application domains. Analysing a variety of building blocks shows that both areas can benefit from generic solution pattern, keeping in mind that each domain has distinguished knowledge realms. Generic patterns as well as distinguished special features are illustrated by analysing state of the art solutions plus some experimental approaches, as there are: the generic part of the HL7 V3 RIM, the RCRIM work, laboratory information handling, vital sign standardization efforts, like ECG information models.Finally, the precision of the usage of the ubiquitous term "metadata" is taken as example of an open issue.

New engineering: from knowledge to competences

NASA Astrophysics Data System (ADS)

Cartagena, M. C.; Tarquis, A. M.; Arce, A.

2009-04-01

One of the main innovations of Bologna system has been to link learning outcomes, ECTS workload based credits and competences. Competences represent a dynamic combination of knowledge, understanding, skills and abilities. Competences can be distinguished in subject specific and generic ones (instrumental, interpersonal and systemic competences). Actually in Spain Engineering degrees are changing to the new University educational system and should aim to satisfy the real needs of European society. This change has been long and complex, particularly. on the issue that have influenced curricular change Consultation with "actors" and "stakeholders", the definition of academic and professionals profiles and the translation of these into desired learning outcomes. Generic competences or transferable skills are relevant for preparing students well for their future role in society in terms of employability and citizenship. The criteria used by the companies to select their engineers are based in a good background and capacity to adapt and to acquire new knowledge, better than specific education, even postgraduate. It was interesting to note the great importance of generic competences However, Spanish government has regulated conditions of core curriculum need for to guarantee the acquisition of the competences needs to exercise the correspondent professional activities. The new degrees should comply with the core curriculum if the graduates want maintain the legal attributions guaranteed actually by the Spanish Professional Associations. After these degrees, students can access to professional master with actually horizontal attributions of regulated professions.

A generic concept to overcome bandgap limitations for designing highly efficient multi-junction photovoltaic cells

PubMed Central

Guo, Fei; Li, Ning; Fecher, Frank W.; Gasparini, Nicola; Quiroz, Cesar Omar Ramirez; Bronnbauer, Carina; Hou, Yi; Radmilović, Vuk V.; Radmilović, Velimir R.; Spiecker, Erdmann; Forberich, Karen; Brabec, Christoph J.

2015-01-01

The multi-junction concept is the most relevant approach to overcome the Shockley–Queisser limit for single-junction photovoltaic cells. The record efficiencies of several types of solar technologies are held by series-connected tandem configurations. However, the stringent current-matching criterion presents primarily a material challenge and permanently requires developing and processing novel semiconductors with desired bandgaps and thicknesses. Here we report a generic concept to alleviate this limitation. By integrating series- and parallel-interconnections into a triple-junction configuration, we find significantly relaxed material selection and current-matching constraints. To illustrate the versatile applicability of the proposed triple-junction concept, organic and organic-inorganic hybrid triple-junction solar cells are constructed by printing methods. High fill factors up to 68% without resistive losses are achieved for both organic and hybrid triple-junction devices. Series/parallel triple-junction cells with organic, as well as perovskite-based subcells may become a key technology to further advance the efficiency roadmap of the existing photovoltaic technologies. PMID:26177808

A generic concept to overcome bandgap limitations for designing highly efficient multi-junction photovoltaic cells.

PubMed

Guo, Fei; Li, Ning; Fecher, Frank W; Gasparini, Nicola; Ramirez Quiroz, Cesar Omar; Bronnbauer, Carina; Hou, Yi; Radmilović, Vuk V; Radmilović, Velimir R; Spiecker, Erdmann; Forberich, Karen; Brabec, Christoph J

2015-07-16

The multi-junction concept is the most relevant approach to overcome the Shockley-Queisser limit for single-junction photovoltaic cells. The record efficiencies of several types of solar technologies are held by series-connected tandem configurations. However, the stringent current-matching criterion presents primarily a material challenge and permanently requires developing and processing novel semiconductors with desired bandgaps and thicknesses. Here we report a generic concept to alleviate this limitation. By integrating series- and parallel-interconnections into a triple-junction configuration, we find significantly relaxed material selection and current-matching constraints. To illustrate the versatile applicability of the proposed triple-junction concept, organic and organic-inorganic hybrid triple-junction solar cells are constructed by printing methods. High fill factors up to 68% without resistive losses are achieved for both organic and hybrid triple-junction devices. Series/parallel triple-junction cells with organic, as well as perovskite-based subcells may become a key technology to further advance the efficiency roadmap of the existing photovoltaic technologies.

Thermalization and its mechanism for generic quantum isolated systems

NASA Astrophysics Data System (ADS)

Olshanii, Maxim; Dunjko, Vanja; Rigol, Marcos

2008-05-01

Time dynamics of isolated many-body quantum systems has long been an elusive subject, perhaps most urgently needed in the foundations of quantum statistical mechanics. In generic systems, one expects the nonequilibrium dynamics to lead to thermalization: a relaxation to states where the values of macroscopic quantities are stationary, universal with respect to widely differing initial conditions, and predictable through the time-tested recipe of statistical mechanics. The relaxation mechanism is not obvious, however; dynamical chaos cannot play the key role as it does in classical systems since quantum evolution is linear. Here we demonstrateootnotetextM. Rigol, V. Dunjko, and M. Olshanii, to appear in Nature (2008), using the results of an ab initio numerical experiment with 5 hard-core bosons moving in a 5x5 lattice, that in quantum systems thermalization happens not in course of time evolution but instead at the level of individual eigenstates, as first proposed by DeutschootnotetextJ. M. Deutsch, Phys.Rev. A 43, 2046 (1991) and SrednickiootnotetextM. Srednicki, Phys. Rev. E 50, 888 (1994).

Identification and Characterization of Key Human Performance Issues and Research in the Next Generation Air Transportation System (NextGen)

NASA Technical Reports Server (NTRS)

Lee, Paul U.; Sheridan, Tom; Poage, james L.; Martin, Lynne Hazel; Jobe, Kimberly K.

2010-01-01

This report identifies key human-performance-related issues associated with Next Generation Air Transportation System (NextGen) research in the NASA NextGen-Airspace Project. Four Research Focus Areas (RFAs) in the NextGen-Airspace Project - namely Separation Assurance (SA), Airspace Super Density Operations (ASDO), Traffic Flow Management (TFM), and Dynamic Airspace Configuration (DAC) - were examined closely. In the course of the research, it was determined that the identified human performance issues needed to be analyzed in the context of NextGen operations rather than through basic human factors research. The main gaps in human factors research in NextGen were found in the need for accurate identification of key human-systems related issues within the context of specific NextGen concepts and better design of the operational requirements for those concepts. By focusing on human-system related issues for individual concepts, key human performance issues for the four RFAs were identified and described in this report. In addition, mixed equipage airspace with components of two RFAs were characterized to illustrate potential human performance issues that arise from the integration of multiple concepts.

Task-Based Pronunciation Teaching and Research: Key Issues and Future Directions

ERIC Educational Resources Information Center

Mora, Joan C.; Levkina, Mayya

2017-01-01

This article synthesizes the conclusions of the empirical studies in this special issue and outlines key questions in future research. The research reported in this volume has identified several fundamental issues in pronunciation-focused task design that are discussed in detail and on which suggestions for further research are outlined. One…

Key Policy Issues in the Implementation of User Choice. Working Paper No. 8.

ERIC Educational Resources Information Center

Smith, Joy Selby; Smith, Chris Selby; Ferrier, Fran

This working paper examines key policy issues in the implementation of Australia's User Choice policy regarding allocating public funds for vocational education and training (VET). Part 1 explains the process used to obtain stakeholders regarding the User Choice policy, the administrative arrangements required to support it, and issues that must…

Is there a relationship between patient beliefs or communication about generic drugs and medication utilization?

PubMed

Shrank, William H; Cadarette, Suzanne M; Cox, Emily; Fischer, Michael A; Mehta, Jyotsna; Brookhart, Alan M; Avorn, Jerry; Choudhry, Niteesh K

2009-03-01

Insurers and policymakers strive to stimulate more cost-effective prescribing and, increasingly, are educating beneficiaries about generics. To evaluate the relationship between patient beliefs and communication about generic drugs and actual drug use. We performed a national mailed survey of a random sample of 2500 commercially-insured adults. Patient responses were linked to pharmacy claims data to assess actual generic medication use. We used factor analysis to develop 5 multi-item scales from patient survey responses that measured: (1) general preferences for generics, (2) generic safety/effectiveness, (3) generic cost/value, (4) comfort with generic substitution, and (5) communication with providers about generics. The relationship between each scale and the proportion of prescriptions filled for generics was assessed using linear regression, controlling for demographic, health, and insurance characteristics. Separate models were created for each scale and then all 5 scales were included simultaneously in a fully-adjusted model. The usable response rate was 48%. When evaluated independently, a 1 SD increase in each of the 5 scales was associated with a 3.1% to 6.3% increase in generic drug use (P < 0.05 for each). In the fully adjusted model, only 2 scales were significantly associated with generic drug use: comfort with generic substitution (P = 0.021) and communication with providers about generic drugs (P = 0.012). Generic drug use is most closely associated with the 2 actionable items we evaluated: communication with providers about generics and comfort with generic substitution. Educational campaigns that focus on these 2 domains may be most effective at influencing generic drug use.

A new mesophotic goby, Palatogobius incendius (Teleostei: Gobiidae), and the first record of invasive lionfish preying on undescribed biodiversity.

PubMed

Tornabene, Luke; Baldwin, Carole C

2017-01-01

A new species of deep-reef fish in the goby genus Palatogobius is described from recent submersible collections off Curaçao and Dominica. Video footage of schools of this species reveal predation by the invasive Indo-Pacific lionfish (Pterois spp.), the first record of undescribed fauna potentially being eaten by lionfish outside of its native range. We present molecular phylogenetic data for all valid species of Palatogobius and related genera, as well as a taxonomic key to the species of Palatogobius and a generic key to Palatogobius and related genera in the western Atlantic. Lastly, we discuss ecological and behavioral aspects of some deep-reef fishes in light of potential threats from invasive lionfish.

On generic obstructions to recovering correct statistics from climate simulations: Homogenization for deterministic maps and multiplicative noise

NASA Astrophysics Data System (ADS)

Gottwald, Georg; Melbourne, Ian

2013-04-01

Whereas diffusion limits of stochastic multi-scale systems have a long and successful history, the case of constructing stochastic parametrizations of chaotic deterministic systems has been much less studied. We present rigorous results of convergence of a chaotic slow-fast system to a stochastic differential equation with multiplicative noise. Furthermore we present rigorous results for chaotic slow-fast maps, occurring as numerical discretizations of continuous time systems. This raises the issue of how to interpret certain stochastic integrals; surprisingly the resulting integrals of the stochastic limit system are generically neither of Stratonovich nor of Ito type in the case of maps. It is shown that the limit system of a numerical discretisation is different to the associated continuous time system. This has important consequences when interpreting the statistics of long time simulations of multi-scale systems - they may be very different to the one of the original continuous time system which we set out to study.

Prescription of antibiotics and awareness of antibiotic costs by paediatricians in two hospitals in Greece.

PubMed

Maltezou, Helena C; Mougkou, Katerina; Iosifidis, Elias; Katerelos, Panos; Roilides, Emmanuel; Theodoridou, Maria

2014-02-01

Our aim was to study the antibiotic prescription practices and the knowledge about antibiotic costs, brand and generic drugs of paediatricians working in two hospitals in Greece. The 2007 national guidelines were used as the gold standard for antibiotic prescription. A total of 126 paediatricians participated in the study (50.4% response rate). The mean compliance rate with the guidelines was 50.1% (range per infection: 10.6-84.7%). The mean scores of knowledge about antibiotic costs and about brand name and generic drugs were 35.6 and 60.3%, respectively. Linear regression analysis found a significant association between the mean compliance rate with the national guidelines and the paediatricians' age (mean compliance rates were 49.1, 53.0, and 43.0% in the ≤ 30, 31-40, and > 40 years age-groups, respectively; P  =  0.003). In conclusion, five years after the first national guidelines were issued in Greece only half of the paediatricians working in hospitals comply fully with them.

Modeling Zone-3 Protection with Generic Relay Models for Dynamic Contingency Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huang, Qiuhua; Vyakaranam, Bharat GNVSR; Diao, Ruisheng

This paper presents a cohesive approach for calculating and coordinating the settings of multiple zone-3 protections for dynamic contingency analysis. The zone-3 protections are represented by generic distance relay models. A two-step approach for determining zone-3 relay settings is proposed. The first step is to calculate settings, particularly, the reach, of each zone-3 relay individually by iteratively running line open-end fault short circuit analysis; the blinder is also employed and properly set to meet the industry standard under extreme loading conditions. The second step is to systematically coordinate the protection settings of the zone-3 relays. The main objective of thismore » coordination step is to address the over-reaching issues. We have developed a tool to automate the proposed approach and generate the settings of all distance relays in a PSS/E dyr format file. The calculated zone-3 settings have been tested on a modified IEEE 300 system using a dynamic contingency analysis tool (DCAT).« less

A report from CPhI Worldwide 2013, Fifth Annual Pre-Connect Conference (October 22-24, 2013 - Frankfurt, Germany).

PubMed

Kuhrt, K; Gilpatrick, J

2013-11-01

A day before the start of the 2013 Conference on Pharmaceutical Ingredients (CPhI) Worldwide, the world's leading pharmaceutical networking event, a number of attendees gathered for the Fifth Annual Pre-Connect Conference to discuss trends in business development, manufacturing and regulatory arenas. Of the six modules presented at the meeting, one was dedicated to the sourcing environment in emerging markets, with special attention paid to developments in India and China. Other modules evaluated the current trends in the creation of generics and supergenerics in emerging markets. Additionally, there were updates on issues surrounding the regulatory and development hurdles that biosimilars and biobetters are facing today. Common themes for both discussions include appropriate pricing and erosion demographics for generics and biosimilars, licensing scenarios, commercialization strategies, and how to stay competitive and find novel innovations within new delivery systems, improved formulations and modifications to create better quality active pharmaceutical ingredients. Copyright 2013 Prous Science, S.A.U. or its licensors. All rights reserved.

Architectural Optimization of Digital Libraries

NASA Technical Reports Server (NTRS)

Biser, Aileen O.

1998-01-01

This work investigates performance and scaling issues relevant to large scale distributed digital libraries. Presently, performance and scaling studies focus on specific implementations of production or prototype digital libraries. Although useful information is gained to aid these designers and other researchers with insights to performance and scaling issues, the broader issues relevant to very large scale distributed libraries are not addressed. Specifically, no current studies look at the extreme or worst case possibilities in digital library implementations. A survey of digital library research issues is presented. Scaling and performance issues are mentioned frequently in the digital library literature but are generally not the focus of much of the current research. In this thesis a model for a Generic Distributed Digital Library (GDDL) and nine cases of typical user activities are defined. This model is used to facilitate some basic analysis of scaling issues. Specifically, the calculation of Internet traffic generated for different configurations of the study parameters and an estimate of the future bandwidth needed for a large scale distributed digital library implementation. This analysis demonstrates the potential impact a future distributed digital library implementation would have on the Internet traffic load and raises questions concerning the architecture decisions being made for future distributed digital library designs.

Association of authorized generic marketing with prescription drug spending on antidepressants from 2000 to 2011.

PubMed

Cheng, Ning; Banerjee, Tannista; Qian, Jingjing; Hansen, Richard A

Prior research suggests that authorized generic drugs increase competition and decrease prices, but little empirical evidence supports this conclusion. This study evaluated the impact of authorized generic marketing on brand and generic prices. Longitudinal analysis of the household component of the Medical Expenditure Panel Survey. Interview panels over 12 years, with a new panel each year. For each panel, 5 rounds of household interviews were conducted over 30 months. Nationally representative sample of the U.S. civilian noninstitutionalized population, focusing on people using 1 of 5 antidepressant drugs that became generically available between 2000 to 2011. Drugs and dose/formulations with versus without an authorized generic drug marketed. Multiple linear regression models with lagged variables evaluated the effect of an authorized generic on average inflation-adjusted brand and generic price, adjusting for payment sources, generic entry time, competitor price, and year. During 2000-2011, annual brand antidepressant utilization decreased from 51.47 to 7.52 million prescriptions, and generic antidepressant utilization increased from 0 to 88.83 million prescriptions. Over time, payment per prescription for brand prescriptions increased 25% overall, and generic payments decreased 70% for all payer types. With unadjusted data, after generic entry the average brand price decreased $0.59 per year with and $3.62 per year without an authorized generic in the market. Average generic prices decreased $10.30 per year with and $8.47 per year without an authorized generic in the market. In multiple regression models with lagged variables adjusted for heteroscedasticity, payer source, time since generic entry, competitor price, and year, authorized generics significantly reduced average payment for generic (-$3.03) and brand (-$60.64) prescriptions, and over time this price change slowly diminished. Availability of an authorized generic was associated with reduced average generic and brand price in the antidepressant market, supporting prior evidences. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Equipment issues regarding the collection of video data for research

NASA Astrophysics Data System (ADS)

Kung, Rebecca Lippmann; Kung, Peter; Linder, Cedric

2005-12-01

Physics education research increasingly makes use of video data for analysis of student learning and teaching practice. Collection of these data is conceptually simple but execution is often fraught with costly and time-consuming complications. This pragmatic paper discusses the development of systems to record and permanently archive audio and video data in real-time. We focus on a system based upon consumer video DVD recorders, but also give an overview of other technologies and detail issues common to all systems. We detail common yet unexpected complications, particularly with regard to sound quality and compatibility with transcription software. Information specific to fixed and transportable systems, other technology options, and generic and specific equipment recommendations are given in supplemental appendices

Future science issues for Galactic very-high-energy gamma-ray astronomy

NASA Astrophysics Data System (ADS)

Torres, Diego F.

2008-12-01

This work intends to provide a brief summary of some of the Galactic science issues for the next generation of very high energy (VHE) instruments. The latter is here generically understood, as an instrument or set of instruments providing about one order of magnitude more sensitivity at its central energy (at about 1 TeV), but extending the observational window to have a real broadband capability (from a few tens of GeV up to tens of TeV) exceeding at low energies the current VHE threshold for observations set by MAGIC as well as the few-tens-of-GeV sensitivity set by Fermi. Science topics regarding populations of emitters, pulsars and their nebula, binaries, supernova remnants, stars, and their associations, are discussed.

Exploration of picture grammars, grammar learning, and inductive logic programming for image understanding

NASA Astrophysics Data System (ADS)

Ducksbury, P. G.; Kennedy, C.; Lock, Z.

2003-09-01

Grammars have been used for the formal specification of programming languages, and there are a number of commercial products which now use grammars. However, these have tended to be focused mainly on flow control type applications. In this paper, we consider the potential use of picture grammars and inductive logic programming in generic image understanding applications, such as object recognition. A number of issues are considered, such as what type of grammar needs to be used, how to construct the grammar with its associated attributes, difficulties encountered with parsing grammars followed by issues of automatically learning grammars using a genetic algorithm. The concept of inductive logic programming is then introduced as a method that can overcome some of the earlier difficulties.

Considerations in pharmaceutical conversion: focus on antihistamines.

PubMed

Garbus, S B; Moulton, B W; Meltzer, E O; Reich, P R; Weinreb, L F; Friedman, J A; Orland, B I

1997-04-01

The practice of pharmaceutical conversion, which encompasses three types of drug interchange (generic, brand, and therapeutic substitution), is increasing in managed care settings. Pharmaceutical conversion has numerous implications for managed care organizations, their healthcare providers, and their customers. Although drug cost may be a driving consideration in pharmaceutical conversion, a number of other considerations are of equal or greater importance in the decision-making process may affect the overall cost of patient care. Among these considerations are clinical, psychosocial, and safety issues; patient adherence; patient satisfaction; and legal implications of pharmaceutical conversion. Patient-centered care must always remain central to decisions about pharmaceutical conversion. This article discusses the issues related to, and implications of, pharmaceutical conversion utilizing the antihistamines class of drugs as the case situation.

A national survey on availability, price and affordability of selected essential medicines for non communicable diseases in Sri Lanka.

PubMed

Dabare, Panthihage Ruvini L; Wanigatunge, Chandanie A; Beneragama, Bvs Hemantha

2014-08-08

Access to medicines is a universal right. Low availability and low affordability of medicines are issues that deny this right to a significant proportion of the world population. The objective of this study was to determine the availability, price and affordability of essential medicines prescribed to treat non communicable diseases in Sri Lanka. Methodology was based on the 2nd edition of the World Health Organization Health Action International Manual. A country survey was conducted and facilities representing both public and private pharmacies were selected. A total of 109 facilities was surveyed. At each facility data on the availability and prices of 50 essential medicines for non communicable diseases were collected. Percentage availability, median price of originator brand and lowest priced generic, median price ratio to the International Reference Price were calculated for surveyed medicines. Affordability was determined using the daily incomes of the lowest--paid unskilled government worker. Semi government community pharmacies had the highest (>80%) availability while outdoor pharmacies of public health care facilities, private pharmacies and outdoor pharmacies of private hospital showed a fairly high availability (50 - 80%) of surveyed medicines.Unit price of 76% of selected individual medicines was less than ten Sri Lankan rupees. Out of these 28% of medicines cost less than one Sri Lanka rupee. For 21 of the surveyed medicines the median price ratio to the international reference price was less than one. The prices of originator brands for 14 surveyed medicines were more than five times that of the lowest price generics.Less than a single day's wages was adequate to purchase a month's supply of the lowest priced generic of more than 67% of surveyed medicines. The availability of selected essential medicines was fairly high in both public and private sectors in Sri Lanka. Most medicines are affordable to the lowest income earners in the community. There were many generic brands and generics available for most of the medicines in private and semi government community pharmacies increasing both availability and affordability.

PubMed-supported clinical term weighting approach for improving inter-patient similarity measure in diagnosis prediction.

PubMed

Chan, Lawrence Wc; Liu, Ying; Chan, Tao; Law, Helen Kw; Wong, S C Cesar; Yeung, Andy Ph; Lo, K F; Yeung, S W; Kwok, K Y; Chan, William Yl; Lau, Thomas Yh; Shyu, Chi-Ren

2015-06-02

Similarity-based retrieval of Electronic Health Records (EHRs) from large clinical information systems provides physicians the evidence support in making diagnoses or referring examinations for the suspected cases. Clinical Terms in EHRs represent high-level conceptual information and the similarity measure established based on these terms reflects the chance of inter-patient disease co-occurrence. The assumption that clinical terms are equally relevant to a disease is unrealistic, reducing the prediction accuracy. Here we propose a term weighting approach supported by PubMed search engine to address this issue. We collected and studied 112 abdominal computed tomography imaging examination reports from four hospitals in Hong Kong. Clinical terms, which are the image findings related to hepatocellular carcinoma (HCC), were extracted from the reports. Through two systematic PubMed search methods, the generic and specific term weightings were established by estimating the conditional probabilities of clinical terms given HCC. Each report was characterized by an ontological feature vector and there were totally 6216 vector pairs. We optimized the modified direction cosine (mDC) with respect to a regularization constant embedded into the feature vector. Equal, generic and specific term weighting approaches were applied to measure the similarity of each pair and their performances for predicting inter-patient co-occurrence of HCC diagnoses were compared by using Receiver Operating Characteristics (ROC) analysis. The Areas under the curves (AUROCs) of similarity scores based on equal, generic and specific term weighting approaches were 0.735, 0.728 and 0.743 respectively (p < 0.01). In comparison with equal term weighting, the performance was significantly improved by specific term weighting (p < 0.01) but not by generic term weighting. The clinical terms "Dysplastic nodule", "nodule of liver" and "equal density (isodense) lesion" were found the top three image findings associated with HCC in PubMed. Our findings suggest that the optimized similarity measure with specific term weighting to EHRs can improve significantly the accuracy for predicting the inter-patient co-occurrence of diagnosis when compared with equal and generic term weighting approaches.

A synoptic review of the genus Thaumaspis Bolívar (Orthoptera, Tettigoniidae, Meconematinae) with the description of a new genus and four new species

PubMed Central

Wang, Hanqiang; Liu, Xianwei; Li, Kai

2014-01-01

Abstract Two new species of the new genus Athaumaspis gen. n., Athaumaspis minutus sp. n. and Athaumaspis tibetanus sp. n. from Vietnam and China are described. The subgenus Pseudothaumaspis of Thaumaspis is elevated to generic status and another two new species Pseudothaumaspis bispinosus sp. n. and Pseudothaumaspis furcocercus sp. n. are described, the remaining species of Thaumaspis are reviewed and keyed with the four new species. PMID:25349494

Pump CFD code validation tests

NASA Technical Reports Server (NTRS)

Brozowski, L. A.

1993-01-01

Pump CFD code validation tests were accomplished by obtaining nonintrusive flow characteristic data at key locations in generic current liquid rocket engine turbopump configurations. Data were obtained with a laser two-focus (L2F) velocimeter at scaled design flow. Three components were surveyed: a 1970's-designed impeller, a 1990's-designed impeller, and a four-bladed unshrouded inducer. Two-dimensional velocities were measured upstream and downstream of the two impellers. Three-dimensional velocities were measured upstream, downstream, and within the blade row of the unshrouded inducer.

Biosimilars: Company Strategies to Capture Value from the Biologics Market

PubMed Central

Calo-Fernández, Bruno; Martínez-Hurtado, Juan Leonardo

2012-01-01

Patents for several biologic blockbusters will expire in the next few years. The arrival of biosimilars, the biologic equivalent of chemical generics, will have an impact on the current biopharmaceuticals market. Five core capabilities have been identified as paramount for those companies aiming to enter the biosimilars market: research and development, manufacturing, supporting activities, marketing, and lobbying. Understanding the importance of each of these capabilities will be key to maximising the value generated from the biologics patent cliff. PMID:24281342

Is There a Relationship Between Patient Beliefs or Communication About Generic Drugs and Medication Utilization?

PubMed Central

Shrank, William H.; Cadarette, Suzanne M.; Cox, Emily; Fischer, Michael A.; Mehta, Jyotsna; Brookhart, Alan M.; Avorn, Jerry; Choudhry, Niteesh K.

2009-01-01

Background Insurers and policymakers strive to stimulate more cost-effective prescribing and, increasingly, are educating beneficiaries about generics. Objectives To evaluate the relationship between patient beliefs and communication about generic drugs and actual drug use. Research Design and Subjects We performed a national mailed survey of a random sample of 2500 commercially-insured adults. Patient responses were linked to pharmacy claims data to assess actual generic medication use. Measures We used factor analysis to develop 5 multi-item scales from patient survey responses that measured: (1) general preferences for generics, (2) generic safety/effectiveness, (3) generic cost/value, (4) comfort with generic substitution, and (5) communication with providers about generics. The relationship between each scale and the proportion of prescriptions filled for generics was assessed using linear regression, controlling for demographic, health, and insurance characteristics. Separate models were created for each scale and then all 5 scales were included simultaneously in a fully-adjusted model. Results The usable response rate was 48%. When evaluated independently, a 1 SD increase in each of the 5 scales was associated with a 3.1% to 6.3% increase in generic drug use (P < 0.05 for each). In the fully adjusted model, only 2 scales were significantly associated with generic drug use: comfort with generic substitution (P = 0.021) and communication with providers about generic drugs (P = 0.012). Conclusions Generic drug use is most closely associated with the 2 actionable items we evaluated: communication with providers about generics and comfort with generic substitution. Educational campaigns that focus on these 2 domains may be most effective at influencing generic drug use. PMID:19194329

Integrating Water, Actors, and Structure to Study Socio-Hydro-Ecological Systems

NASA Astrophysics Data System (ADS)

Hale, R. L.; Armstrong, A.; Baker, M. A.; Bedingfield, S.; Betts, D.; Buahin, C. A.; Buchert, M.; Crowl, T.; Dupont, R.; Endter-Wada, J.; Flint, C.; Grant, J.; Hinners, S.; Horns, D.; Horsburgh, J. S.; Jackson-Smith, D.; Jones, A. S.; Licon, C.; Null, S. E.; Odame, A.; Pataki, D. E.; Rosenberg, D. E.; Runburg, M.; Stoker, P.; Strong, C.

2014-12-01

Urbanization, climate uncertainty, and ecosystem change represent major challenges for managing water resources. Water systems and the forces acting upon them are complex, and there is a need to understand and generically represent the most important system components and linkages. We developed a framework to facilitate understanding of water systems including potential vulnerabilities and opportunities for sustainability. Our goal was to produce an interdisciplinary framework for water resources research to address water issues across scales (e.g., city to region) and domains (e.g., water supply and quality, urban and transitioning landscapes). An interdisciplinary project (iUTAH - innovative Urban Transitions and Aridregion Hydro-sustainability) with a large (N=~100), diverse team having expertise spanning the hydrologic, biological, ecological, engineering, social, planning, and policy sciences motivated the development of this framework. The framework was developed through review of the literature, meetings with individual researchers, and workshops with participants. The Structure-Water-Actor Framework (SWAF) includes three main components: water (quality and quantity), structure (natural, built, and social), and actors (individual and organizational). Key linkages include: 1) ecological and hydrological processes, 2) ecosystem and geomorphic change, 3) planning, design, and policy, 4) perceptions, information, and experience, 5) resource access, and 6) operational water use and management. Our expansive view of structure includes natural, built, and social components, allowing us to examine a broad set of tools and levers for water managers and decision-makers to affect system sustainability and understand system outcomes. We validate the SWAF and illustrate its flexibility to generate insights for three research and management problems: green stormwater infrastructure in an arid environment, regional water supply and demand, and urban river restoration. These applications show that the framework can help identify key components and linkages across diverse water systems.

Single Channel EEG Artifact Identification Using Two-Dimensional Multi-Resolution Analysis.

PubMed

Taherisadr, Mojtaba; Dehzangi, Omid; Parsaei, Hossein

2017-12-13

As a diagnostic monitoring approach, electroencephalogram (EEG) signals can be decoded by signal processing methodologies for various health monitoring purposes. However, EEG recordings are contaminated by other interferences, particularly facial and ocular artifacts generated by the user. This is specifically an issue during continuous EEG recording sessions, and is therefore a key step in using EEG signals for either physiological monitoring and diagnosis or brain-computer interface to identify such artifacts from useful EEG components. In this study, we aim to design a new generic framework in order to process and characterize EEG recording as a multi-component and non-stationary signal with the aim of localizing and identifying its component (e.g., artifact). In the proposed method, we gather three complementary algorithms together to enhance the efficiency of the system. Algorithms include time-frequency (TF) analysis and representation, two-dimensional multi-resolution analysis (2D MRA), and feature extraction and classification. Then, a combination of spectro-temporal and geometric features are extracted by combining key instantaneous TF space descriptors, which enables the system to characterize the non-stationarities in the EEG dynamics. We fit a curvelet transform (as a MRA method) to 2D TF representation of EEG segments to decompose the given space to various levels of resolution. Such a decomposition efficiently improves the analysis of the TF spaces with different characteristics (e.g., resolution). Our experimental results demonstrate that the combination of expansion to TF space, analysis using MRA, and extracting a set of suitable features and applying a proper predictive model is effective in enhancing the EEG artifact identification performance. We also compare the performance of the designed system with another common EEG signal processing technique-namely, 1D wavelet transform. Our experimental results reveal that the proposed method outperforms 1D wavelet.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Speetjens, M. F. M.; Demissie, E. A.; Metcalfe, G.

Laminar mixing by the inline-mixing principle is a key to many industrial fluids-engineering systems of size extending from micrometers to meters. However, insight into fundamental transport phenomena particularly under the realistic conditions of three-dimensionality (3D) and fluid inertia remains limited. This study addresses these issues for inline mixers with cylindrical geometries and adopts the Rotated Arc Mixer (RAM) as a representative system. Transport is investigated from a Lagrangian perspective by identifying and examining coherent structures that form in the 3D streamline portrait. 3D effects and fluid inertia introduce three key features that are not found in simplified configurations: transition zonesmore » between consecutive mixing cells of the inline-mixing flow; local upstream flow (in certain parameter regimes); transition/inertia-induced breaking of symmetries in the Lagrangian equations of motion (causing topological changes in coherent structures). Topological considerations strongly suggest that there nonetheless always exists a net throughflow region between inlet and outlet of the inline-mixing flow that is strictly separated from possible internal regions. The Lagrangian dynamics in this region admits representation by a 2D time-periodic Hamiltonian system. This establishes one fundamental kinematic structure for the present class of inline-mixing flows and implies universal behavior in that all states follow from the Hamiltonian breakdown of one common integrable state. A so-called period-doubling bifurcation is the only way to eliminate transport barriers originating from this state and thus is a necessary (yet not sufficient) condition for global chaos. Important in a practical context is that a common simplification in literature, i.e., cell-wise fully-developed Stokes flow (“2.5D approach”), retains these fundamental kinematic properties and deviates from the generic 3D inertial case only in a quantitative sense. This substantiates its suitability for (at least first exploratory) studies on (qualitative) mixing properties.« less

Ecosystem services and livelihoods in deltaic environments

NASA Astrophysics Data System (ADS)

Nicholls, R. J.; Rahman, M. M.; Salehin, M.; Hutton, C.

2015-12-01

While overall, deltas account for only 1% of global land area, they are home to more than a half billion people or ca. 7% of the world's population. In many deltas, livelihoods and food security are strongly dependent on ecosystem services, which in turn are affected by various environmental change factors, including climate variability and change, modifications to upstream river, sediment and nutrient fluxes, evolving nearshore ecosystems, and delta-level change factors such as subsidence, changing land use and management interventions such as polders. Key limits include scarcity of fresh water, saline water intrusion and the impacts of extreme events (e.g. river floods, cyclones and storm surges), which constrain land use choices and livelihood opportunities for the deltaic populations. The ESPA Deltas project takes a systemic perspective of the interaction between the coupled bio-physical environment and the livelihoods of rural delta residents. The methods emphasise poverty reduction and use coastal Bangladesh as an example. This includes a set of consistent biophysical analyses of the delta and the upstream catchments and the downstream Bay of Bengal, as well as governance and policy analysis and socio-demographic analysis, including an innovative household survey on ecosystem utilization. These results are encapsulated in an integrated model that analyses ecosystem services and livelihood implications. This integrated approach is designed to support delta-level policy formulation. It allows the exploration of contrasting development trajectories, including issues such as robustness of different governance options on ecosystem services and livelihoods. The method is strongly participatory including an ongoing series of stakeholder workshops addressing issue identification, scenario development and consideration of policy responses. The methods presented are generic and transferable to other deltas. The paper will consider the overall ESPA Deltas project and its wider lessons for integrated assessment of deltaic environments.

Standardisation of the FAERS database: a systematic approach to manually recoding drug name variants.

PubMed

Wong, Carmen K; Ho, Samuel S; Saini, Bandana; Hibbs, David E; Fois, Romano A

2015-07-01

The US Food and Drug Administration Adverse Event Reporting System (FAERS), one of the world's largest spontaneous reporting systems, is difficult to use because of report duplication and a lack of standardisation in the recording of drug names. Unresolved data quality issues may distort statistical analyses, rendering the results difficult to interpret when detecting and monitoring adverse effects of pharmaceutical products. The aim of this study was to develop and implement a data cleaning protocol to identify and resolve drug nomenclature issues. The key 'data treatment' plan involved standardising drug names held in the FAERS database. Four million five hundred and six thousand five hundred and seventy-seven. Individual Safety Reports submitted to the FAERS between 1 January 2003 and 31 August 2012 were included for this study. OpenRefine was used to standardise drug name variants in the database such that they were consistent with international non-proprietary nomenclature defined by the World Health Organisation Anatomical Therapeutic Chemical classification. Drug variants where generic constituents could not be confidently determined, undecipherable drug names and non-medicinal products were retained verbatim. After the standardisation process, more than 16 611 916 drug entries were cleaned to their relevant international non-proprietary name. The cleaned drug table comprised 71 858 drug name variants and includes both standardised and original terms. Ninety-nine per cent of drug names was standardised using this method. The millions of reports enclosed in the FAERS contain valuable information that is of interest to pharmacovigilance, toxicology and post-marketing surveillance researchers. With the standardisation of the drug nomenclature, the database can be better utilised by research groups around the world. Copyright © 2015 John Wiley & Sons, Ltd.

Structural Design of Dual-Mode Ramjets and Associated System Issues (Conception structurale des statoreacteurs mixtes et defis systeme associes)

DTIC Science & Technology

2010-09-01

Institute PAO Protection Against Oxidation RBCC Rocket Based Combined Cycle RSL Reusable Space Launchers SSTO Single Stage to Orbit TOW Take-Off Weight...Orbit) or Single Stage To Orbit ( SSTO ) vehicles, or other kind of hypersonic vehicles. For example, in the scope of the French PREPHA program, the...study of a generic SSTO vehicle led to conclusion that the best type of airbreathing engine could be the dual-mode ramjet (subsonic then supersonic

DOE Office of Scientific and Technical Information (OSTI.GOV)

Va'Vra, J.

The publication of the ICFA Instrumentation Bulletin is an activity of the Panel on Future Innovation and Development of ICFA (International Committee for Future Accelerators). The Bulletin reports on research and progress in the field of instrumentation with emphasis on application in the field of high-energy physics. It encourages issues of generic instrumentation. This volume contains the following articles: (1) ''Gaseous Micropattern Detectors: High-Energy Physics and Beyond''; (2) ''DIRC Dreams Redux: Research Directions for the Next Generation of Internally Reflected Imaging Counters''; and (3) ''Corrosion of Glass Windows in DIRC PMTs''.

A Feasibility Study on the Control of a Generic Air Vehicle Using Control Moment Gyros

NASA Technical Reports Server (NTRS)

Lim, Kyong B.; Moerder, Daniel D.

2006-01-01

This paper examines feasibility and performance issues in using Control Moment Gyroscopes (CMGs) to control the attitude of a fixed-wing aircraft. The paper describes a control system structure that permits allocating control authority and bandwidth between a CMG system and conventional aerodynamic control surfaces to stabilize a vehicle with neutral aerodynamic stability. A simulation study explores the interplay between aerodynamic and CMG effects, and indicates desirable physical characteristics for a CMG system to be used for aircraft attitude control.

AADL Fault Modeling and Analysis Within an ARP4761 Safety Assessment

DTIC Science & Technology

2014-10-01

Analysis Generator 27 3.2.3 Mapping to OpenFTA Format File 27 3.2.4 Mapping to Generic XML Format 28 3.2.5 AADL and FTA Mapping Rules 28 3.2.6 Issues...PSSA), System Safety Assessment (SSA), Common Cause Analysis (CCA), Fault Tree Analysis ( FTA ), Failure Modes and Effects Analysis (FMEA), Failure...Modes and Effects Summary, Mar - kov Analysis (MA), and Dependence Diagrams (DDs), also referred to as Reliability Block Dia- grams (RBDs). The

An instability in neutron stars at birth

NASA Technical Reports Server (NTRS)

Burrows, Adam; Fryxell, Bruce A.

1992-01-01

Calculations with a two-dimensional hydrodynamic simulation show that a generic Raleigh-Taylor-like instability occurs in the mantles of nascent neutron stars, that it is possibly violent, and that the standard spherically symmetric models of neutron star birth and supernova explosion may be inadequate. Whether this 'convective' instability is pivotal to the supernova mechanism, pulsar nagnetic fields, or a host of other important issues that attend stellar collapse remains to be seen, but its existence promises to modify all questions concerning this most energetic of astronomical phenomena.

Optical linear algebra processors - Architectures and algorithms

NASA Technical Reports Server (NTRS)

Casasent, David

1986-01-01

Attention is given to the component design and optical configuration features of a generic optical linear algebra processor (OLAP) architecture, as well as the large number of OLAP architectures, number representations, algorithms and applications encountered in current literature. Number-representation issues associated with bipolar and complex-valued data representations, high-accuracy (including floating point) performance, and the base or radix to be employed, are discussed, together with case studies on a space-integrating frequency-multiplexed architecture and a hybrid space-integrating and time-integrating multichannel architecture.

Workplace wellness programs in Canada: an exploration of key issues.

PubMed

Morrison, Erin; MacKinnon, Neil J

2008-01-01

Faced with the reality of rising health costs, Canadian employers are thinking beyond traditional notions of responsibility for employee health and have begun to embrace Workplace Wellness Programs (WWPs). This article investigates the critical issues of WWPs in the Canadian context from the perspective of key stakeholders. Using a combination of literature and key informant interviews, seven key themes are presented along with recommendations for wider implementation of WWPs in Canada.

The balancing act: key issues in the lives of women general practitioners in Australia.

PubMed

Kilmartin, Margaret R; Newell, Christopher J; Line, Martin A

2002-07-15

To identify key issues affecting women general practitioners in their professional and non-professional lives. A qualitative study using the Delphi technique, with three rounds of data provision circulated to each participant. Coding was used to ensure anonymity. The participants were a purposive sample of 40 women GPs drawn from all Australian States and Territories. The study was conducted between October 1996 and January 1997. Key issues affecting the professional and non-professional lives of women GPs. Some of the key professional issues for women GPs were job satisfaction, balancing work and personal life, autonomy, availability of flexible and part-time work and training, affordability of professional expenses, fair remuneration, and having a voice in decision-making. Key non-professional issues included self-care; time for relationships with a partner, children, family and friends; and time management to allow pursuit of non-medical interests. The conflicting demands made on women GPs diminish their job satisfaction and lead to stress and imbalance in their lives. Recommendations to ameliorate the problems for women GPs include appropriate training, policy formation, financial and other support, and a change in cultural expectations of women GPs by the community, the profession and governments.

Framing access to medicines in developing countries: an analysis of media coverage of Canada's Access to Medicines Regime

PubMed Central

2010-01-01

Background In September 2003, the Canadian government committed to developing legislation that would facilitate greater access to affordable medicines for developing countries. Over the course of eight months, the legislation, now known as Canada's Access to Medicines Regime (CAMR), went through a controversial policy development process and the newspaper media was one of the major venues in which the policy debates took place. The purpose of this study was to examine how the media framed CAMR to determine how policy goals were conceptualized, which stakeholder interests controlled the public debate and how these variables related to the public policy process. Methods We conducted a qualitative content analysis of newspaper coverage of the CAMR policy and implementation process from 2003-2008. The primary theoretical framework for this study was framing theory. A total of 90 articles from 11 Canadian newspapers were selected for inclusion in our analysis. A team of four researchers coded the articles for themes relating to access to medicines and which stakeholders' voice figured more prominently on each issue. Stakeholders examined included: the research-based industry, the generic industry, civil society, the Canadian government, and developing country representatives. Results The most frequently mentioned themes across all documents were the issues of drug affordability, intellectual property, trade agreements and obligations, and development. Issues such as human rights, pharmaceutical innovation, and economic competitiveness got little media representation. Civil society dominated the media contents, followed far behind by the Canadian government, the research-based and generic pharmaceutical industries. Developing country representatives were hardly represented in the media. Conclusions Media framing obscured the discussion of some of the underlying policy goals in this case and failed to highlight issues which are now significant barriers to the use of the legislation. Using the media to engage the public in more in-depth exploration of the policy issues at stake may contribute to a more informed policy development process. The media can be an effective channel for those stakeholders with a weaker voice in policy deliberations to raise public attention to particular issues; however, the political and institutional context must be taken into account as it may outweigh media framing effects. PMID:20044940

Key Higher-Education Issues in the States

ERIC Educational Resources Information Center

Fischer, Karin; Hebel, Sara

2007-01-01

Legislatures are set to convene in January in 43 states. This article presents the key issues that are expected to be debated by legislatures in states this year. These issues include: (1) Annulment of a controversial law in Texas that guarantees students who graduate in the top 10 percent of their high-school classes admission to any public…

Understanding Key Education Issues: How We Got Here and Where We Go from Here

ERIC Educational Resources Information Center

Lynch, Matthew

2017-01-01

In this age of education innovation and reform, schools must evolve and react to current policy trends. This accessible book offers research-based insights into six key educational trends and issues that are impacting K-12 learning today: year-round schooling, assessments, educating minorities, anti-intellectualism, issues of social promotion and…

The Market Dynamics of Generic Medicines in the Private Sector of 19 Low and Middle Income Countries between 2001 and 2011: A Descriptive Time Series Analysis

PubMed Central

Kaplan, Warren A.; Wirtz, Veronika J.; Stephens, Peter

2013-01-01

This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive “switching” to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted. PMID:24098644

The market dynamics of generic medicines in the private sector of 19 low and middle income countries between 2001 and 2011: a descriptive time series analysis.

PubMed

Kaplan, Warren A; Wirtz, Veronika J; Stephens, Peter

2013-01-01

This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted.

Generics, Supergenerics and Patent Strategies--SMi's 13th Annual Meeting.

PubMed

Edwards, Catherine

2010-07-01

SMi's 13th Annual Meeting on Generics, Supergenerics and Patent Strategies, held in London, included topics covering new trends in the generics field, the difficulties faced by companies in entering the generics market and recent developments in IP. This conference report highlights selected presentations on generics in India, protecting pharmaceutical products in China, changes in generics law and litigation in the US and Europe, challenges for market selection and entry for generics companies, the influence of changes in the healthcare market on the generics industry, supergenerics, and biosimilars.

Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

PubMed

Alatawi, Y; Rahman, Md M; Cheng, N; Qian, J; Peissig, P L; Berg, R L; Page, C D; Hansen, R A

2018-06-01

Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P < .01). Inconsistent reporting patterns were observed more between brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported. © 2017 John Wiley & Sons Ltd.

Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.

PubMed

Hansen, Richard A; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K; Raofi, Saeid; Page, C David; Peissig, Peggy

2017-04-01

Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic-to-brand switchback rates between generic and AGs. Retrospective cohort study. Claims and electronic health record data from a regional U.S. health care system. The full cohort consisted of 5542 unique patients who received select branded drugs during the 6 months prior to their generic drug market availability (between 1999 and 2014) and then were switched to an AG or generic drug within 30 months of generic drug entry. For these patients, 5929 unique patient-drug combinations (867 with AGs and 5062 with generic drugs) were evaluated. Ten drugs with AGs and generics marketed between 1999 and 2014 were evaluated. The date of the first generic prescription was considered the index date for each drug, and it marked the beginning of follow-up to evaluate the occurrence of generic-to-brand switchback patterns over the subsequent 30 months. Switchback rates were compared between patients receiving AGs versus those receiving generics using multivariable Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson Comorbidity Score, pre-index drug use characteristics, and pre-index health care utilization. Among the 5542 unique patients who switched from brand to generic or brand to AG, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for AGs compared with generics (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15). The likelihood of switchback was higher for alendronate (HR 1.64, 95% CI 1.20-2.23) and simvastatin (HR 1.81, 95% CI 1.30-2.54) and lower for amlodipine (HR 0.27, 95% CI 0.17-0.42) compared with the other drugs evaluated. Overall switchback rates were similar between AG and generic drug users, indirectly supporting similar efficacy and tolerability profiles for brand and generic drugs. Reasons for differences in switchback rates among specific products need to be explored further. © 2017 Pharmacotherapy Publications, Inc.

For Dr. Nancy Snyderman's Parents, Staying Close to Family Is Key

MedlinePlus

... Issues Feature: Senior Living For Dr. Nancy Snyderman's Parents, Staying Close to Family Is Key Past Issues / ... home. "Watching my children grow closer to my parents has been a blessing, and having us nearby ...

27 CFR 4.24 - Generic, semi-generic, and non-generic designations of geographic significance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Generic, semi-generic, and non-generic designations of geographic significance. 4.24 Section 4.24 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND...

Generic drugs in Brazil: known by many, used by few.

PubMed

Bertoldi, Andréa D; Barros, Aluísio J D; Hallal, Pedro C

2005-01-01

This study evaluated knowledge and use of generic drugs in a population-based sample of adults from a southern Brazilian city. The outcomes were: the proportion of generics in total medicines used; theoretical and practical knowledge about generics; and strategies used to buy medicines on medical prescriptions. The recall period for drug utilization was 15 days. The proportion of generics in total medicines was 3.9%. While 86.0% knew that generics cost less and 70.0% that the quality is similar to brand name medicines, only 57.0% knew any packaging characteristics that distinguish generics from other medicines. The highest proportion of generic drug utilization was in the antimicrobial pharmacological group. A brand name medicine (with a brand similar to the generic name) was mistakenly classified as a generic through photos by 48.0% of the interviewees. Among subjects who bought medicines in the 15-day period, 18.9% reported buying a generic, but this result should be interpreted with caution, because the population frequently fails to differentiate between generics and other medicines.

Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

PubMed

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya V; Peissig, Peggy L; Berg, Richard L; Page, David; Hansen, Richard A

2017-09-01

Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected P<0.01. A total of 27,150 events with lamotrigine, 13,950 events with carbamazepine, and 5077 events with oxcarbazepine were reported, with generics accounting for 27%, 41%, and 32% of reports, respectively. Although RORs for the majority of known AEs were different between brand and generics for all three drugs of interest (Breslow-Day P<0.001), RORs generally were similar for AG and generic comparisons. Generic lamotrigine and carbamazepine were more commonly involved in reports of suicide or suicidal ideation compared with the respective AGs based on a multiple comparison-adjusted P<0.01. Similar AED reporting rates were observed for the AG and generic comparisons for most outcomes and drugs, suggesting that brands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B.V. All rights reserved.

Knowledge, perceptions and use of generic drugs: a cross sectional study

PubMed Central

de Lira, Claudio Andre Barbosa; Oliveira, Jéssica Nathalia Soares; Andrade, Marília dos Santos; Vancini-Campanharo, Cássia Regina; Vancini, Rodrigo Luiz

2014-01-01

Objective To assess the level of knowledge, perceptions and usage profile for generic drugs among laypersons. Methods A cross-sectional study was conducted with 278 volunteers (180 women and 98 men, aged 37.1±15.8 years). A questionnaire was drawn up with questions on their use, perceptions and knowledge of generic drugs. Results Most respondents (99.6%) knew that generic drugs exist, but only 48.6% were able to define them correctly, while 78.8% of the respondents had some information about generics. This information was obtained mainly through television (49.3%). In terms of generic drug characteristics, 79.1% stated that they were confident about their efficacy, 74.8% believed that generic drugs have the same effect as branded medications, 88.8% said that generics were priced lower than branded medications, and 80.2% stated that they bought generic drugs because of price. With regard to drugs prescribed by medical practitioners, 17.6% of the participants said that their doctors never prescribed generics and only 7.5% confirmed that their doctors always prescribed generics. Conclusion For the lay public, the sample in this study has sufficient knowledge of generic drugs in terms of definition, efficacy and cost. Consequently, the volunteers interviewed are very likely to use generics. Furthermore, the results of this study indicate that programs should be implemented in order to boost generic drug prescriptions by medical practitioners. PMID:25295444

What use is generic prescribing?

PubMed Central

Archer, Michael

1985-01-01

The dispensing of generic preparations at four dispensing chemist shops was investigated by means of a questionnaire. Certain generic prescriptions result in the dispensing of proprietary products despite the existence of generic preparations, and the pharmacist may be reimbursed for the cost of the proprietary drug which has been dispensed. Not all generic prescriptions result in the dispensing of cheaper drugs because of the methods of payment to chemists. If doctors write more generic prescriptions there will ultimately be more dispensing of generic products. Even in the case of drugs still under patent, prescribing by generic name should be encouraged. The savings achieved by generic prescribing are to some extent at the cost of the dispensing chemists. The method and scale of payments for dispensing requires urgent review. PMID:4032358

Washington state short line rail inventory and needs assessment.

DOT National Transportation Integrated Search

2015-06-01

The recently completed State Rail Plan for the state of Washington identified several key issues facing the states : rail system. Among these key issues are abandonment, port access and competitive needs of the ports and local : production regions...

Key Issues in Instructional Computer Graphics.

ERIC Educational Resources Information Center

Wozny, Michael J.

1981-01-01

Addresses key issues facing universities which plan to establish instructional computer graphics facilities, including computer-aided design/computer aided manufacturing systems, role in curriculum, hardware, software, writing instructional software, faculty involvement, operations, and research. Thirty-seven references and two appendices are…

Impact of medicare part D plan features on use of generic drugs.

PubMed

Tang, Yan; Gellad, Walid F; Men, Aiju; Donohue, Julie M

2014-06-01

Little is known about how Medicare Part D plan features influence choice of generic versus brand drugs. To examine the association between Part D plan features and generic medication use. Data from a 2009 random sample of 1.6 million fee-for-service, Part D enrollees aged 65 years and above, who were not dually eligible or receiving low-income subsidies, were used to examine the association between plan features (generic cost-sharing, difference in brand and generic copay, prior authorization, step therapy) and choice of generic antidepressants, antidiabetics, and statins. Logistic regression models accounting for plan-level clustering were adjusted for sociodemographic and health status. Generic cost-sharing ranged from $0 to $9 for antidepressants and statins, and from $0 to $8 for antidiabetics (across 5th-95th percentiles). Brand-generic cost-sharing differences were smallest for statins (5th-95th percentiles: $16-$37) and largest for antidepressants ($16-$64) across plans. Beneficiaries with higher generic cost-sharing had lower generic use [adjusted odds ratio (OR)=0.97, 95% confidence interval (CI), 0.95-0.98 for antidepressants; OR=0.97, 95% CI, 0.96-0.98 for antidiabetics; OR=0.94, 95% CI, 0.92-0.95 for statins]. Larger brand-generic cost-sharing differences and prior authorization were significantly associated with greater generic use in all categories. Plans could increase generic use by 5-12 percentage points by reducing generic cost-sharing from the 75th ($7) to 25th percentiles ($4-$5), increasing brand-generic cost-sharing differences from the 25th ($25-$26) to 75th ($32-$33) percentiles, and using prior authorization and step therapy. Cost-sharing features and utilization management tools were significantly associated with generic use in 3 commonly used medication categories.

Do higher-priced generic medicines enjoy a competitive advantage under reference pricing?

PubMed

Puig-Junoy, Jaume

2012-11-01

In many countries with generic reference pricing, generic producers and distributors compete by means of undisclosed discounts offered to pharmacies in order to reduce acquisition costs and to induce them to dispense their generic to patients in preference over others. The objective of this article is to test the hypothesis that under prevailing reference pricing systems for generic medicines, those medicines sold at a higher consumer price may enjoy a competitive advantage. Real transaction prices for 179 generic medicines acquired by pharmacies in Spain have been used to calculate the discount rate on acquisition versus reimbursed costs to pharmacies. Two empirical hypotheses are tested: the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical presentations for which there are more generic competitors; and, the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical forms for which the consumer price has declined less in relation to the consumer price of the brand drug before generic entry (higher-priced generic medicines). An average discount rate of 39.3% on acquisition versus reimbursed costs to pharmacies has been observed. The magnitude of the discount positively depends on the number of competitors in the market. The higher the ratio of the consumer price of the generic to that of the brand drug prior to generic entry (i.e. the smaller the price reduction of the generic in relation to the brand drug), the larger the discount rate. Under reference pricing there is intense price competition among generic firms in the form of unusually high discounts to pharmacies on official ex-factory prices reimbursed to pharmacies. However, this effect is highly distorting because it favours those medicines with a higher relative price in relation to the brand price before generic entry.

Questionnaire on the awareness of generic drugs among outpatients and medical staff.

PubMed

Hoshi, S; Kimura, H

2008-06-01

Generic drugs are not as widely used in Japan as they are in the West. The objective of this study was to survey the awareness of generic drugs among outpatients and medical staff and propose methods of promoting the use of generic drugs. Our survey showed that 86.7% of respondents were aware of generic drugs. This is a higher awareness rate than that in a survey of other groups conducted last year. One reason to explain this higher awareness is the recent increase in generic drug advertisements both in newspapers and on television. However, a point of note is that generic drug usage has not increased. Our survey also showed that generic drug awareness was differed widely among age groups, as younger respondents were much more aware of generic drugs than older respondents. Still, about 40% of respondents who were aware of generic drugs did not realize that they were less expensive than name-brand drugs ? including 30% of medical staff. In addition to continuing advertisement of generic drugs in the media, medical doctors and pharmacists should also be encouraged to endorse the use of generic drugs. Furthermore a new system allowing for substitution prescriptions started in April 2008 and consequently pharmacists can now play an important role in promoting the use of generic drugs.

Analysis of French generic medicines retail market: why the use of generic medicines is limited.

PubMed

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2014-12-01

The market share of generic medicines in France is low compared to other European countries. This perspective paper provides an overview of the generic medicines retail market in France and how the current policy environment may affect the long-term sustainability. Looking at the French generic medicines retail market and the surrounding regulatory framework, all conditions seem to be in place to create a healthy generic medicines market: the country has well-respected regulatory authorities, generic medicines enter the market in a timely manner and prices of generic medicines are competitive compared with other European countries. Despite the success of the demand-side policies targeted at pharmacists and patients, those targeted at physicians were less successful due to a lack of enforcement and a lack of trust in generic medicines by French physicians. Recommendations to increase the use of generic medicines in France round off this perspective paper.

Health-related quality of life in children and adolescents who use cochlear implants.

PubMed

Warner-Czyz, Andrea D; Loy, Betty; Tobey, Emily A; Nakonezny, Paul; Roland, Peter S

2011-01-01

Examination of health-related quality of life (HRQoL) in children and adolescents who wear a cochlear implant (CI) primarily has depended on parent proxy report of the child's HRQoL rather than child self-report and generic domains rather than CI-specific issues. This study simultaneously assessed self-report ratings on a generic HRQoL instrument and a preliminary CI module in pediatric CI users. The impact of demographic factors (chronologic age, age at CI, and CI experience) on HRQoL also was explored. This cross-sectional study included 138 children grouped by chronologic age: 4-7, 8-11 and 12-16 years. The KINDL(R) questionnaire for measuring HRQoL in children and adolescents (generic) and a preliminary CI module (specific) were completed as a researcher-administered interview (4-7 years) or self-administered questionnaire (8-16 years) at CI summer camp or home. Scores were transformed to a 100-point scale with 100 representing the most positive response. The impact of chronologic age group on HRQoL ratings was evaluated using Analysis of Variance. Spearman rank-order correlations and point-biserial correlations tested associations between demographic factors and HRQoL scores. Principal factor analysis was used to discover the factor structure and internal consistency of the preliminary CI module. The youngest group (M=82.8) rated generic HRQoL significantly more positively than older children (8-11 years: M=75.3; 12-16 years: M=70.4). Similar significant results emerged on the overall CI module (4-7 years: M=79.8; 8-11 years: M=77.8; 12-16 years: M=71.3). The youngest group rated CI-specific items on friends and self-image more positively than older groups, but reported greater difficulties hearing teachers at school. The oldest group provided more consistent responses than younger groups on the CI module (Cronbach α=0.72). Generic and CI module scores correlated positively (r=0.19, p=.03) but this association reflects the strong correlation in the oldest group (r=0.49, p=0.0033) and camouflages non-significant results in younger groups. Chronologic age impacts self-report of HRQoL for pediatric CI users such that younger children rate HRQoL more positively than older children and adolescents on a generic instrument and preliminary CI module. Older children provide more consistent responses on the CI module. Results support the need for further development of a CI-specific self-report HRQoL instrument. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Perception of Generic Prescription Drugs and Utilization of Generic Drug Discount Programs

PubMed Central

Omojasola, Anthony; Hernandez, Mike; Sansgiry, Sujit; Jones, Lovell

2012-01-01

Objective Our study aimed to assess patient’s perceptions of generic drugs and utilization of generic drug discount programs. Design, Setting and Participants A survey was administered to adult participants at community health centers and community-based organizations in Houston, Texas, USA (n=525). Main Outcome Measures Multivariate logistic regression was used to quantify the strength of association between generic drug perception and utilization of generic drug discount programs. Results Respondents who agreed that “Generic prescription drugs are as effective as brand name prescription drugs,” were 3 times as likely to utilize generic drug discount programs (AOR: 3.0, 95% CI: 1.8–4.8, P<.001). Compared to non-Hispanic Whites, African Americans (OR: 10.2; 95% CI: 1.4–76.4) and Hispanics (OR: 10.3; 95% CI: 1.3–79.4) were 10 times as likely to agree that generic drugs have more side effects than brand name drugs. Conclusion Race/ethnicity had no impact in utilization of generic drug discount programs, despite racial disparities in perception toward generic drugs’ side effects and generic drugs being inferior to brand name drugs. PMID:23140080

Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates.

PubMed

Dellson, P; Nilbert, M; Bendahl, P-O; Malmström, P; Carlsson, C

2011-07-01

Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used in three clinical trials for breast cancer. Primary data collection was done in focus group interviews with breast cancer patient advocates. Content analysis identified three major themes: comprehensibility, emotions and associations, and decision making. Based on the advocates' suggestions for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials. © 2010 Blackwell Publishing Ltd.

A new mesophotic goby, Palatogobius incendius (Teleostei: Gobiidae), and the first record of invasive lionfish preying on undescribed biodiversity

PubMed Central

Baldwin, Carole C.

2017-01-01

A new species of deep-reef fish in the goby genus Palatogobius is described from recent submersible collections off Curaçao and Dominica. Video footage of schools of this species reveal predation by the invasive Indo-Pacific lionfish (Pterois spp.), the first record of undescribed fauna potentially being eaten by lionfish outside of its native range. We present molecular phylogenetic data for all valid species of Palatogobius and related genera, as well as a taxonomic key to the species of Palatogobius and a generic key to Palatogobius and related genera in the western Atlantic. Lastly, we discuss ecological and behavioral aspects of some deep-reef fishes in light of potential threats from invasive lionfish. PMID:28542432

LifeWatch - a Large-scale eScience Infrastructure to Assist in Understanding and Managing our Planet's Biodiversity

NASA Astrophysics Data System (ADS)

Hernández Ernst, Vera; Poigné, Axel; Los, Walter

2010-05-01

Understanding and managing the complexity of the biodiversity system in relation to global changes concerning land use and climate change with their social and economic implications is crucial to mitigate species loss and biodiversity changes in general. The sustainable development and exploitation of existing biodiversity resources require flexible and powerful infrastructures offering, on the one hand, the access to large-scale databases of observations and measures, to advanced analytical and modelling software, and to high performance computing environments and, on the other hand, the interlinkage of European scientific communities among each others and with national policies. The European Strategy Forum on Research Infrastructures (ESFRI) selected the "LifeWatch e-science and technology infrastructure for biodiversity research" as a promising development to construct facilities to contribute to meet those challenges. LifeWatch collaborates with other selected initiatives (e.g. ICOS, ANAEE, NOHA, and LTER-Europa) to achieve the integration of the infrastructures at landscape and regional scales. This should result in a cooperating cluster of such infrastructures supporting an integrated approach for data capture and transmission, data management and harmonisation. Besides, facilities for exploration, forecasting, and presentation using heterogeneous and distributed data and tools should allow the interdisciplinary scientific research at any spatial and temporal scale. LifeWatch is an example of a new generation of interoperable research infrastructures based on standards and a service-oriented architecture that allow for linkage with external resources and associated infrastructures. External data sources will be established data aggregators as the Global Biodiversity Information Facility (GBIF) for species occurrences and other EU Networks of Excellence like the Long-Term Ecological Research Network (LTER), GMES, and GEOSS for terrestrial monitoring, the MARBEF network for marine data, and the Consortium for European Taxonomic Facilities (CETAF) and its European Distributed Institute for Taxonomy (EDIT) for taxonomic data. But also "smaller" networks and "volunteer scientists" may send data (e.g. GPS supported species observations) to a LifeWatch repository. Autonomous operating wireless environmental sensors and other smart hand-held devices will contribute to increase data capture activities. In this way LifeWatch will directly underpin the development of GEOBON, the biodiversity component if GEOSS, the Global Earth observation System. To overcome all major technical difficulties imposed by the variety of currently and future technologies, protocols, data formats, etc., LifeWatch will define and use common open interfaces. For this purpose, the LifeWatch Reference Model was developed during the preparatory phase specifying the service-oriented architecture underlying the ICT-infrastructure. The Reference Model identifies key requirements and key architectural concepts to support workflows for scientific in-silico experiments, tracking of provenance, and semantic enhancement, besides meeting the functional requirements mentioned before. It provides guidelines for the specification and implementation of services and information models, defining as well a number of generic services and models. Another key issue addressed by the Reference Model is that the cooperation of many developer teams residing in many European countries has to be organized to obtain compatible results in that conformance with the specifications and policies of the Reference Model will be required. The LifeWatch Reference Model is based on the ORCHESTRA Reference Model for geospatial-oriented architectures and services networks that provides a generic framework and has been endorsed as best practice by the Open Geospatial Consortium (OGC). The LifeWatch Infrastructure will allow (interdisciplinary) scientific researchers to collaborate by creating e-Laboratories or by composing e-Services which can be shared and jointly developed. For it a long-term vision for the LifeWatch Biodiversity Workbench Portal has been developed as a one-stop application for the LifeWatch infrastructure based on existing and emerging technologies. There the user can find all available resources such as data, workflows, tools, etc. and access LifeWatch applications that integrate different resource and provides key capabilities like resource discovery and visualisation, creation of workflows, creation and management of provenance, and the support of collaborative activities. While LifeWatch developers will construct components for solving generic LifeWatch tasks, users may add their own facilities to fulfil individual needs. Examples for application of the LifeWatch Reference Model and the LifeWatch Biodiversity Workbench Portal will be given.

The Portuguese generic medicines market: a policy analysis

PubMed Central

Simoens, Steven

2008-01-01

Objectives: This study aims to conduct a descriptive analysis of the policy environment surrounding the generic medicines retail market in Portugal. The policy analysis focuses on supply-side measures (i.e. market access, pricing, reference-pricing and reimbursement of generic medicines) and demand-side measures (i.e. incentives for physicians to prescribe, for pharmacists to dispense and for patients to use generic medicines). Methods: The policy analysis was based on an international literature review. Also, a simulation exercise was carried out to compute potential savings from substituting generic for originator medicines in Portugal using IMS Health data. Results: Portugal has developed a successful generic medicines market by increasing reimbursement of generic medicines (until October 2005), by introducing a reference-pricing system, by encouraging physicians to prescribe by international non-proprietary name (INN), and by allowing generic substitution by pharmacists. However, the development of the generic medicines market has been hindered by the existence of copies, pricing regulation, certain features of the reference-pricing system, weak incentives for physicians to prescribe generic medicines and a financial disincentive for pharmacists to dispense generic medicines. Increased generic substitution would be expected to reduce public expenditure on originator medicines by 45%. Conclusions: The development of the Portuguese generic medicines market has mainly been fuelled by supply-side measures. To support the further expansion of the market, policy makers need to strengthen demand-side measures inciting physicians to prescribe, pharmacists to dispense and patients to use generic medicines. PMID:25152781

A summary and integration of research concerning single pilot IFR operational problems

NASA Technical Reports Server (NTRS)

Chapman, G. C.

1983-01-01

A review of seven research studies pertaining to Single Pilot IFR (SPIFR) operations was performed. Two studies were based on questionnaire surveys; two based on National Transportation Safety Board (NTSB) reports; two were based on Aviation Safety Reporting System (ASRS) incident reports, and one report used event analysis and statistics to forecast problems. The results obtained in each study were extracted and integrated. Results were synthesized and key issues pertaining to SPIFR operations problems were identified. The research that was recommended by the studies and that addressed the key issues is catalogued for each key issue.

A System for Modelling Cell–Cell Interactions during Plant Morphogenesis

PubMed Central

Dupuy, Lionel; Mackenzie, Jonathan; Rudge, Tim; Haseloff, Jim

2008-01-01

Background and aims During the development of multicellular organisms, cells are capable of interacting with each other through a range of biological and physical mechanisms. A description of these networks of cell–cell interactions is essential for an understanding of how cellular activity is co-ordinated in regionalized functional entities such as tissues or organs. The difficulty of experimenting on living tissues has been a major limitation to describing such systems, and computer modelling appears particularly helpful to characterize the behaviour of multicellular systems. The experimental difficulties inherent to the multitude of parallel interactions that underlie cellular morphogenesis have led to the need for computer models. Methods A new generic model of plant cellular morphogenesis is described that expresses interactions amongst cellular entities explicitly: the plant is described as a multi-scale structure, and interactions between distinct entities is established through a topological neighbourhood. Tissues are represented as 2D biphasic systems where the cell wall responds to turgor pressure through a viscous yielding of the cell wall. Key Results This principle was used in the development of the CellModeller software, a generic tool dedicated to the analysis and modelling of plant morphogenesis. The system was applied to three contrasting study cases illustrating genetic, hormonal and mechanical factors involved in plant morphogenesis. Conclusions Plant morphogenesis is fundamentally a cellular process and the CellModeller software, through its underlying generic model, provides an advanced research tool to analyse coupled physical and biological morphogenetic mechanisms. PMID:17921524

A method to improve the nutritional quality of foods and beverages based on dietary recommendations.

PubMed

Nijman, C A J; Zijp, I M; Sierksma, A; Roodenburg, A J C; Leenen, R; van den Kerkhoff, C; Weststrate, J A; Meijer, G W

2007-04-01

The increasing consumer interest in health prompted Unilever to develop a globally applicable method (Nutrition Score) to evaluate and improve the nutritional composition of its foods and beverages portfolio. Based on (inter)national dietary recommendations, generic benchmarks were developed to evaluate foods and beverages on their content of trans fatty acids, saturated fatty acids, sodium and sugars. High intakes of these key nutrients are associated with undesirable health effects. In principle, the developed generic benchmarks can be applied globally for any food and beverage product. Product category-specific benchmarks were developed when it was not feasible to meet generic benchmarks because of technological and/or taste factors. The whole Unilever global foods and beverages portfolio has been evaluated and actions have been taken to improve the nutritional quality. The advantages of this method over other initiatives to assess the nutritional quality of foods are that it is based on the latest nutritional scientific insights and its global applicability. The Nutrition Score is the first simple, transparent and straightforward method that can be applied globally and across all food and beverage categories to evaluate the nutritional composition. It can help food manufacturers to improve the nutritional value of their products. In addition, the Nutrition Score can be a starting point for a powerful health indicator front-of-pack. This can have a significant positive impact on public health, especially when implemented by all food manufacturers.

Big issues, small systems: managing with information in medical research.

PubMed

Jones, J; Preston, H

2000-08-01

This subject of this article is the design of a database system for handling files related to the work of the Molecular Genetics Department of the International Blood Group Reference Laboratory. It examines specialist information needs identified within this organization and it indicates how the design of the Rhesus Information Tracking System was able to meet current needs. Rapid Applications Development prototyping forms the basis of the investigation, linked to interview, questionnaire, and observation techniques in order to establish requirements for interoperability. In particular, the place of this specialist database within the much broader information strategy of the National Blood Service will be examined. This unique situation is analogous to management activities in broader environments and a number of generic issues are highlighted by the research.

Making Temporal Logic Calculational: A Tool for Unification and Discovery

NASA Astrophysics Data System (ADS)

Boute, Raymond

In temporal logic, calculational proofs beyond simple cases are often seen as challenging. The situation is reversed by making temporal logic calculational, yielding shorter and clearer proofs than traditional ones, and serving as a (mental) tool for unification and discovery. A side-effect of unifying theories is easier access by practicians. The starting point is a simple generic (software tool independent) Functional Temporal Calculus (FTC). Specific temporal logics are then captured via endosemantic functions. This concept reflects tacit conventions throughout mathematics and, once identified, is general and useful. FTC also yields a reasoning style that helps discovering theorems by calculation rather than just proving given facts. This is illustrated by deriving various theorems, most related to liveness issues in TLA+, and finding strengthenings of known results. Educational issues are addressed in passing.

Issues in the use of Weapons-Grade MOX Fuel in VVER-1000 Nuclear Reactors: Comparison of UO2 and MOX Fuels

DOE Office of Scientific and Technical Information (OSTI.GOV)

Carbajo, J.J.

2005-05-27

The purpose of this report is to quantify the differences between mixed oxide (MOX) and low-enriched uranium (LEU) fuels and to assess in reasonable detail the potential impacts of MOX fuel use in VVER-1000 nuclear power plants in Russia. This report is a generic tool to assist in the identification of plant modifications that may be required to accommodate receiving, storing, handling, irradiating, and disposing of MOX fuel in VVER-1000 reactors. The report is based on information from work performed by Russian and U.S. institutions. The report quantifies each issue, and the differences between LEU and MOX fuels are describedmore » as accurately as possible, given the current sources of data.« less

Experimentation and evaluation of advanced integrated system concepts

NASA Astrophysics Data System (ADS)

Ross, M.; Garrigus, K.; Gottschalck, J.; Rinearson, L.; Longee, E.

1980-09-01

This final report examines the implementation of a time-phased test bed for experimentation and evaluation of advanced system concepts relative to the future Defense Switched Network (DSN). After identifying issues pertinent to the DSN, a set of experiments which address these issues are developed. Experiments are ordered based on their immediacy and relative importance to DSN development. The set of experiments thus defined allows requirements for a time phased implementation of a test bed to be identified, and several generic test bed architectures which meet these requirements are examined. Specific architecture implementations are costed and cost/schedule profiles are generated as a function of experimental capability. The final recommended system consists of two separate test beds: a circuit switch test bed, configured around an off-the-shelf commercial switch, and directed toward the examination of nearer term and transitional issues raised by the evolving DSN; and a packet/hybrid test bed, featuring a discrete buildup of new hardware and software modules, and directed toward examination of the more advanced integrated voice and data telecommunications issues and concepts.

Measuring performance in off-patent drug markets: a methodological framework and empirical evidence from twelve EU Member States.

PubMed

Kanavos, Panos

2014-11-01

This paper develops a methodological framework to help evaluate the performance of generic pharmaceutical policies post-patent expiry or after loss of exclusivity in non-tendering settings, comprising five indicators (generic availability, time delay to and speed of generic entry, number of generic competitors, price developments, and generic volume share evolution) and proposes a series of metrics to evaluate performance. The paper subsequently tests this framework across twelve EU Member States (MS) by using IMS data on 101 patent expired molecules over the 1998-2010 period. Results indicate that significant variation exists in generic market entry, price competition and generic penetration across the study countries. Size of a geographical market is not a predictor of generic market entry intensity or price decline. Regardless of geographic or product market size, many off patent molecules lack generic competitors two years after loss of exclusivity. The ranges in each of the five proposed indicators suggest, first, that there are numerous factors--including institutional ones--contributing to the success of generic entry, price decline and market penetration and, second, MS should seek a combination of supply and demand-side policies in order to maximise cost-savings from generics. Overall, there seems to be considerable potential for faster generic entry, uptake and greater generic competition, particularly for molecules at the lower end of the market. Copyright © 2014. Published by Elsevier Ireland Ltd.

Long-term evaluation of solid oxide fuel cell candidate materials in a 3-cell generic stack test fixture, part III: Stability and microstructure of Ce-(Mn,Co)-spinel coating, AISI441 interconnect, alumina coating, cathode and anode

NASA Astrophysics Data System (ADS)

Chou, Yeong-Shyung; Stevenson, Jeffry W.; Choi, Jung-Pyung

2014-07-01

A generic solid oxide fuel cell stack test fixture was developed to evaluate candidate materials and processing under realistic conditions. Part III of the work investigated the stability of Ce-(Mn,Co) spinel coating, AISI441 metallic interconnect, alumina coating, and cell's degradation. After 6000 h test, the spinel coating showed densification with some diffusion of Cr. At the metal interface, segregation of Si and Ti was observed, however, no continuous layer formed. The alumina coating for perimeter sealing areas appeared more dense and thick at the air side than the fuel side. Both the spinel and alumina coatings remained bonded. EDS analysis of Cr within the metal showed small decrease in concentration near the coating interface and would expect to cause no issue of Cr depletion. Inter-diffusion of Ni, Fe, and Cr between spot-welded Ni wire and AISI441 interconnect was observed and Cr-oxide scale formed along the circumference of the weld. The microstructure of the anode and cathode was discussed relating to degradation of the top and middle cells. Overall, the Ce-(Mn,Co) spinel coating, alumina coating, and AISI441 steel showed the desired long-term stability and the developed generic stack fixture proved to be a useful tool to validate candidate materials for SOFC.

A Automated Tool for Supporting FMEAs of Digital Systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yue,M.; Chu, T.-L.; Martinez-Guridi, G.

2008-09-07

Although designs of digital systems can be very different from each other, they typically use many of the same types of generic digital components. Determining the impacts of the failure modes of these generic components on a digital system can be used to support development of a reliability model of the system. A novel approach was proposed for such a purpose by decomposing the system into a level of the generic digital components and propagating failure modes to the system level, which generally is time-consuming and difficult to implement. To overcome the associated issues of implementing the proposed FMEA approach,more » an automated tool for a digital feedwater control system (DFWCS) has been developed in this study. The automated FMEA tool is in nature a simulation platform developed by using or recreating the original source code of the different module software interfaced by input and output variables that represent physical signals exchanged between modules, the system, and the controlled process. For any given failure mode, its impacts on associated signals are determined first and the variables that correspond to these signals are modified accordingly by the simulation. Criteria are also developed, as part of the simulation platform, to determine whether the system has lost its automatic control function, which is defined as a system failure in this study. The conceptual development of the automated FMEA support tool can be generalized and applied to support FMEAs for reliability assessment of complex digital systems.« less

Designing of a Digital Behind-the-Ear Hearing Aid to Meet the World Health Organization Requirements

PubMed Central

Bento, Ricardo Ferreira; Penteado, Silvio Pires

2010-01-01

Hearing loss is a common health issue that affects nearly 10% of the world population as indicated by many international studies. The hearing impaired typically experience more frustration, anxiety, irritability, depression, and disorientation than those with normal hearing levels. The standard rehabilitation tool for hearing impairment is an electronic hearing aid whose main components are transducers (microphone and receiver) and a digital signal processor. These electronic components are manufactured by supply chain rather than by hearing aid manufacturers. Manufacturers can use custom-designed components or generic off-the-shelf components. These electronic components are available as application-specific or off-the-shelf products, with the former designed for a specific manufacturer and the latter for a generic approach. The choice of custom or generic components will affect the product specifications, pricing, manufacturing, life cycle, and marketing strategies of the product. The World Health Organization is interested in making available to developing countries hearing aids that are inexpensive to purchase and maintain. The hearing aid presented in this article was developed with these specifications in mind together with additional contemporary features such as four channels with wide dynamic range compression, an adjustable compression rate for each channel, four comfort programs, an adaptive feedback manager, and full volume control. This digital hearing aid is fitted using a personal computer with minimal hardware requirements in intuitive three-step fitting software. A trimmer-adjusted version can be developed where human and material resources are scarce. PMID:20724354

Generic concepts in Nectriaceae

PubMed Central

Lombard, L.; van der Merwe, N.A.; Groenewald, J.Z.; Crous, P.W.

2015-01-01

The ascomycete family Nectriaceae (Hypocreales) includes numerous important plant and human pathogens, as well as several species used extensively in industrial and commercial applications as biodegraders and biocontrol agents. Members of the family are unified by phenotypic characters such as uniloculate ascomata that are yellow, orange-red to purple, and with phialidic asexual morphs. The generic concepts in Nectriaceae are poorly defined, since DNA sequence data have not been available for many of these genera. To address this issue we performed a multi-gene phylogenetic analysis using partial sequences for the 28S large subunit (LSU) nrDNA, the internal transcribed spacer region and intervening 5.8S nrRNA gene (ITS), the large subunit of the ATP citrate lyase (acl1), the RNA polymerase II largest subunit (rpb1), RNA polymerase II second largest subunit (rpb2), α-actin (act), β-tubulin (tub2), calmodulin (cmdA), histone H3 (his3), and translation elongation factor 1-alpha (tef1) gene regions for available type and authentic strains representing known genera in Nectriaceae, including several genera for which no sequence data were previously available. Supported by morphological observations, the data resolved 47 genera in the Nectriaceae. We re-evaluated the status of several genera, which resulted in the introduction of six new genera to accommodate species that were initially classified based solely on morphological characters. Several generic names are proposed for synonymy based on the abolishment of dual nomenclature. Additionally, a new family is introduced for two genera that were previously accommodated in the Nectriaceae. PMID:26955195

Designing of a digital behind-the-ear hearing aid to meet the World Health Organization requirements.

PubMed

Bento, Ricardo Ferreira; Penteado, Silvio Pires

2010-06-01

Hearing loss is a common health issue that affects nearly 10% of the world population as indicated by many international studies. The hearing impaired typically experience more frustration, anxiety, irritability, depression, and disorientation than those with normal hearing levels. The standard rehabilitation tool for hearing impairment is an electronic hearing aid whose main components are transducers (microphone and receiver) and a digital signal processor. These electronic components are manufactured by supply chain rather than by hearing aid manufacturers. Manufacturers can use custom-designed components or generic off-the-shelf components. These electronic components are available as application-specific or off-the-shelf products, with the former designed for a specific manufacturer and the latter for a generic approach. The choice of custom or generic components will affect the product specifications, pricing, manufacturing, life cycle, and marketing strategies of the product. The World Health Organization is interested in making available to developing countries hearing aids that are inexpensive to purchase and maintain. The hearing aid presented in this article was developed with these specifications in mind together with additional contemporary features such as four channels with wide dynamic range compression, an adjustable compression rate for each channel, four comfort programs, an adaptive feedback manager, and full volume control. This digital hearing aid is fitted using a personal computer with minimal hardware requirements in intuitive three-step fitting software. A trimmer-adjusted version can be developed where human and material resources are scarce.

Using threshold messages to promote physical activity: implications for public perceptions of health effects.

PubMed

Knox, Emily C L; Webb, Oliver J; Esliger, Dale W; Biddle, Stuart J H; Sherar, Lauren B

2014-04-01

The promotion of physical activity (PA) guidelines to the general public is an important issue that lacks empirical investigation. PA campaigns often feature participation thresholds that cite PA guidelines verbatim [e.g., 150 min/week moderate-to-vigorous physical activity (MVPA)]. Some campaigns instead prefer to use generic PA messages (e.g., do as much MVPA as possible). 'Thresholds' may disrupt understanding of the health benefits of modest PA participation. This study examined the perception of health benefits of PA after exposure to PA messages that did and did not contain a duration threshold. Brief structured interviews were conducted with a convenience sample of adults (n = 1100). Participants received a threshold message (150 min/week MVPA), a message that presented the threshold as a minimum; a generic message or no message. Participants rated perceived health effects of seven PA durations. One-way analyses of variance with post hoc tests for group differences were used to assess raw perception ratings for each duration of PA. Recipients of all three messages held more positive perceptions of >150 min/week of MVPA relative to those not receiving any message. For MVPA durations <150 min/week, the generic PA message group perceived the greatest health benefits. Those receiving the threshold message tended to have the least positive perceptions of durations <150 min/week. Threshold messages were associated with lower perceived health benefits for modest PA durations. Campaigns based on threshold messages may be limited when promoting small PA increases at a population level.