Sample records for generic structure potential
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Montefusco, Alberto; Consonni, Francesco; Beretta, Gian Paolo
2015-04-01
By reformulating the steepest-entropy-ascent (SEA) dynamical model for nonequilibrium thermodynamics in the mathematical language of differential geometry, we compare it with the primitive formulation of the general equation for the nonequilibrium reversible-irreversible coupling (GENERIC) model and discuss the main technical differences of the two approaches. In both dynamical models the description of dissipation is of the "entropy-gradient" type. SEA focuses only on the dissipative, i.e., entropy generating, component of the time evolution, chooses a sub-Riemannian metric tensor as dissipative structure, and uses the local entropy density field as potential. GENERIC emphasizes the coupling between the dissipative and nondissipative components of the time evolution, chooses two compatible degenerate structures (Poisson and degenerate co-Riemannian), and uses the global energy and entropy functionals as potentials. As an illustration, we rewrite the known GENERIC formulation of the Boltzmann equation in terms of the square root of the distribution function adopted by the SEA formulation. We then provide a formal proof that in more general frameworks, whenever all degeneracies in the GENERIC framework are related to conservation laws, the SEA and GENERIC models of the dissipative component of the dynamics are essentially interchangeable, provided of course they assume the same kinematics. As part of the discussion, we note that equipping the dissipative structure of GENERIC with the Leibniz identity makes it automatically SEA on metric leaves.
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Improving the assessment of prescribing: use of a 'substitution index'.
Kunisawa, Susumu; Otsubo, Tetsuya; Lee, Jason; Imanaka, Yuichi
2013-07-01
To analyse the current and potential utilization of generic drugs in Japan, to examine the maximum possible cost savings from generic drug use and to develop a fairer measure to assess the level of generic drug substitution. We conducted a cross-sectional retrospective analysis of nine million dispensing records during January to March 2010 in Kyoto Prefecture. Maximum potential quantity-based shares were defined as the quantity of generic drugs used plus the quantity of branded drugs that could have been replaced by generic drugs divided by the quantity of all drugs dispensed. We developed a 'substitution index', defined as the proportion of generic drugs out of the total drugs substitutable with generic drugs (based on quantity rather than cost). Generic drugs had a quantity-based share of 17.9%, a cost-based share of 8.9% and a maximum potential quantity-based share of 50.1%, which is lower than the actual generic drug shares of some other countries. The maximum possible cost savings as a result of generic drug substitution was 16.5%. We also observed wide variations in maximum potential quantity-based shares between health care sectors and health care institutions. Simple comparisons based on quantity-based shares may misrepresent the actual generic drug use. A substitution index that takes into account the maximum potential quantity-based share of generic drugs as a fairer measure may promote more realistic goals and encourage generic drug usage.
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DNA condensation and size effects of DNA condensation agent
NASA Astrophysics Data System (ADS)
Liu, Yan-Hui; Jiang, Chong-Ming; Guo, Xin-Miao; Tang, Yan-Lin; Hu, Lin
2013-08-01
Based on the model of the strong correlation of counterions condensed on DNA molecule, by tailoring interaction potential, interduplex spacing and correlation spacing between condensed counterions on DNA molecule and interduplex spacing fluctuation strength, toroidal configuration, rod-like configuration and two-hole configurations are possible. The size effects of counterion structure on the toroidal structure can be detected by this model. The autocorrelation function of the tangent vectors is found as an effective way to detect the structure of toroidal conformations and the generic pathway of the process of DNA condensation. The generic pathway of all of the configurations involves an initial nucleation loop, and the next part of the DNA chain is folded on the top of the initial nucleation loop with different manners, in agreement with the recent experimental results.
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Hammond, Matthew D; Cimpian, Andrei
2017-05-01
Stereotypes are typically defined as beliefs about groups, but this definition is underspecified. Beliefs about groups can be generic or statistical. Generic beliefs attribute features to entire groups (e.g., men are strong), whereas statistical beliefs encode the perceived prevalence of features (e.g., how common it is for men to be strong). In the present research, we sought to determine which beliefs-generic or statistical-are more central to the cognitive structure of stereotypes. Specifically, we tested whether generic or statistical beliefs are more influential in people's social judgments, on the assumption that greater functional importance indicates greater centrality in stereotype structure. Relative to statistical beliefs, generic beliefs about social groups were significantly stronger predictors of expectations (Studies 1-3) and explanations (Study 4) for unfamiliar individuals' traits. In addition, consistent with prior evidence that generic beliefs are cognitively simpler than statistical beliefs, generic beliefs were particularly predictive of social judgments for participants with more intuitive (vs. analytic) cognitive styles and for participants higher (vs. lower) in authoritarianism, who tend to view outgroups in simplistic, all-or-none terms. The present studies suggest that generic beliefs about groups are more central than statistical beliefs to the cognitive structure of stereotypes. (PsycINFO Database Record (c) 2017 APA, all rights reserved).
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Walton, Surrey M; Rash, Christine; Lambert, Bruce L; Galanter, William L
2014-11-01
Encouraging generic drug use has reduced health care costs for payers and consumers, but the availability of therapeutically interchangeable medications or generic medications of choice is not equal across disease states. The extent to which systems of care are able to substitute with generics is not well understood. To (a) define and measure the maximum generic rate (MGR) of currently prescribed drugs within an academic medical group in and (b) illustrate differences across drugs associated with selected underlying diseases. Prescription claims data were examined from an academic medical group in Chicago, Illinois. Based on pharmacologic and therapeutic criteria, drugs were classified into 2 categories-potentially substitutable and not potentially substitutable-based on whether the drugs are branded forms of the same chemical entities that are available as generics or are therapeutically interchangeable with other medications that have different chemical compositions but the same mechanisms of action and potential efficacy. A medication was considered potentially substitutable if it (a) did not have a narrow therapeutic index as defined by the FDA; (b) did not belong to 1 of 6 protected classes of drugs in the Medicare D provisions; (c) was substitutable with a generic medication containing the same chemical entity; or (d) was therapeutically interchangeable with a therapeutically equivalent medication. MGR was defined as the percentage of prescriptions that could potentially be prescribed in generic form. This rate was examined overall and across drugs known to be associated with illustrative diseases including hypertension, diabetes mellitus, and obstructive lung diseases. The MGR ranged from 100% for drugs used in hypertension to 26.7% for drugs used in obstructive lung diseases. The MGR was 83.6%. Payers wishing to promote generic substitution should incorporate the potential for substitution of clinically appropriate generic medications as part of incentives for generic utilization to avoid unintended consequences of using a fixed target rate. A practical methodology for determining an MGR is offered.
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Hydrogen and advanced aerospace materials
NASA Technical Reports Server (NTRS)
Nelson, Howard G.
1988-01-01
The hydrogen embrittlement is briefly reviewed and discussed in terms of specific structural materials considered for use on a generic, hydrogen-fueled, hypersonic aerospace vehicle. A few unusual hydrogen-material incompatibility concerns are identified and some solution methodologies are discussed that could potentially lessen these concerns.
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Bloom, Bruce E
2015-12-01
Repurposing research improves patient lives by taking drugs approved for one disease and clinically testing them to create a treatment for a different disease. Repurposing drugs that are generic, inexpensive, and widely available and that can be taken in their current dosage and formulation in the new indication provide a quick, affordable, and effective way to create "new" treatments. However, generic drug repurposing often provides no profit potential, and so there is no economic incentive for industry to pursue this, and philanthropy and government funds are often insufficient. One way to create new economic incentive for the repurposing of generic drugs is through social finance. This perspective describes how social finance can create a new economic incentive by using a social impact bond, or similar financial structure, to repay for-profit investors who fund the repurposing research from the proceeds of healthcare cost reductions generated when these affordable, effective, and widely available repurposed therapies improve healthcare outcomes.
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A Generic Theory of the Integer Quantum Hall Effect
NASA Astrophysics Data System (ADS)
Shen, Yu
The integer quantum Hall effect (IQHE) is usually modeled by a Galilean or rotationally invariant Hamiltonian. These are not generic symmetries for electrons moving in a crystal background and can potentially confuse non-topological quantities with topological ones and identify otherwise distinct geometrical properties. In this thesis we present a generic theory for the IQHE. First we show that a generic guiding-center coherent state, defined by a natural metric in each Landau level, has the form of an antiholomorphic function times a Gaussian factor. Then by numerically solving the eigenproblem for a quartic Hamiltonian and finding the roots of the antiholomorphic part we are able to define a topological spin sn = n + 1/2 where n is the number of central roots that are enclosed by the semiclassical orbit. We derive a generic formula for the Hall viscosity in the absence of rotational symmetry and show that the previous interpretation of the scalar Hall viscosity as the "intrinsic orbital angular momentum" breaks down since the concept of angular momentum requires the presence of rotational symmetry. We also calculate generic electromagnetic responses and differentiate between universal terms that are diagonal with respect to Landau level index and non-universal terms that depend on inter-Landau-level mixing. We conclude that the generic theory offers a fundamental definition for the topological spin and reveals finer structure in the geometrical properties of the IQHE.
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Societal value of generic medicines beyond cost-saving through reduced prices.
Dylst, Pieter; Vulto, Arnold; Simoens, Steven
2015-01-01
This paper aims to provide an overview of the added societal value of generic medicines beyond their cost-saving potential through reduced prices. In addition, an observational case study will document the impact of generic entry on access to pharmacotherapy in The Netherlands and an illustrative exercise was carried out to highlight the budget impact of generic entry. A narrative literature review was carried out to explore the impact of generic medicines on access to pharmacotherapy, innovation and medication adherence. Data from the Medicines and Medical Devices Information Project database in The Netherlands were used for the case study in which the impact of generic medicine entrance on the budget and the number of users was calculated as an illustrative exercise. Generic medicines have an additional societal value beyond their cost-saving potential through reduced prices. Generic medicines increase access to pharmacotherapy, provide a stimulus for innovation by both originator companies and generic companies and, under the right circumstances, have a positive impact on medication adherence. Generic medicines offer more to society than just their cost-saving potential through reduced prices. As such, governments must not focus only on the prices of generic medicines as this will threaten their long-term sustainability. Governments must therefore act appropriately and implement a coherent set of policies to increase the use of generic medicines.
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Statistical Primer on Biosimilar Clinical Development.
Isakov, Leah; Jin, Bo; Jacobs, Ira Allen
A biosimilar is highly similar to a licensed biological product and has no clinically meaningful differences between the biological product and the reference (originator) product in terms of safety, purity, and potency and is approved under specific regulatory approval processes. Because both the originator and the potential biosimilar are large and structurally complex proteins, biosimilars are not generic equivalents of the originator. Thus, the regulatory approach for a small-molecule generic is not appropriate for a potential biosimilar. As a result, different study designs and statistical approaches are used in the assessment of a potential biosimilar. This review covers concepts and terminology used in statistical analyses in the clinical development of biosimilars so that clinicians can understand how similarity is evaluated. This should allow the clinician to understand the statistical considerations in biosimilar clinical trials and make informed prescribing decisions when an approved biosimilar is available.
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NASA Astrophysics Data System (ADS)
Dlugosch, M.; Spiegelhalter, B.; Soot, T.; Lukaszewicz, D.; Fritsch, J.; Hiermaier, S.
2017-05-01
With car manufacturers simultaneously facing increasing passive safety and efficiency requirements, FRP-metal hybrid material systems are one way to design lightweight and crashworthy vehicle structures. Generic automotive hybrid structural concepts have been tested under crash loading conditions. In order to assess the state of overall damage and structural integrity, and primarily to validate simulation data, several NDT techniques have been assessed regarding their potential to detect common damage mechanisms in such hybrid systems. Significant potentials were found particularly in combining 3D-topography laser scanning and X-Ray imaging results. Ultrasonic testing proved to be limited by the signal coupling quality on damaged or curved surfaces.
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Statistical analysis of modeling error in structural dynamic systems
NASA Technical Reports Server (NTRS)
Hasselman, T. K.; Chrostowski, J. D.
1990-01-01
The paper presents a generic statistical model of the (total) modeling error for conventional space structures in their launch configuration. Modeling error is defined as the difference between analytical prediction and experimental measurement. It is represented by the differences between predicted and measured real eigenvalues and eigenvectors. Comparisons are made between pre-test and post-test models. Total modeling error is then subdivided into measurement error, experimental error and 'pure' modeling error, and comparisons made between measurement error and total modeling error. The generic statistical model presented in this paper is based on the first four global (primary structure) modes of four different structures belonging to the generic category of Conventional Space Structures (specifically excluding large truss-type space structures). As such, it may be used to evaluate the uncertainty of predicted mode shapes and frequencies, sinusoidal response, or the transient response of other structures belonging to the same generic category.
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NASA Astrophysics Data System (ADS)
Shukla, Pramod
2016-10-01
In the context of studying the 4D-effective potentials of type IIB nongeometric flux compactifications, this article has a twofold goal. First, we present a modular invariant symplectic rearrangement of the tree level nongeometric scalar potential arising from a flux superpotential which includes the S-dual pairs of nongeometric fluxes (Q , P ), the standard NS-NS and RR three-form fluxes (F3 , H3 ), and the geometric flux (ω ). This "symplectic formulation" is valid for arbitrary numbers of Kähler moduli, and the complex structure moduli which are implicitly encoded in a set of symplectic matrices. In the second part, we further explicitly rewrite all the symplectic ingredients in terms of saxionic and axionic components of the complex structure moduli. The same leads to a compact form of the generic scalar potential being explicitly written out in terms of all the real moduli/axions. Moreover, the final form of the scalar potential needs only the knowledge of some topological data (such as Hodge numbers and the triple-intersection numbers) of the compactifying threefolds and their respective mirrors. Finally, we demonstrate how the same is equivalent to say that, for a given concrete example, various pieces of the scalar potential can be directly read off from our generic proposal, without the need of starting from the Kähler and superpotentials.
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Authorized generic drugs, price competition, and consumers' welfare.
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.
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Long-term Medicaid excess payments from alleged price manipulation of generic lorazepam.
Bian, Boyang; Gorevski, Elizabeth; Kelton, Christina M L; Guo, Jeff J; Martin Boone, Jill E
2012-09-01
Cost savings from the use of generic drugs versus brand-name drugs are well known. Both private and public prescription drug plans encourage the use of generic drugs through a variety of mechanisms. The magnitude of cost savings for a given generic drug is dependent on the degree to which the generic market is competitive. Should the competitive structure become compromised, higher prices and reduced cost savings may result. An alleged conspiracy between Mylan Laboratories and its active-ingredient suppliers in 1997 was associated with an increase in seller concentration in the generic lorazepam market. The Federal Trade Commission (FTC) alleged that Mylan raised costs to consumers by $120 million because of price increases for generic lorazepam from March through December 1998 and for generic clorazepate from January through December 1998. In November 2002, a settlement with Mylan was approved by the FTC, and a federal district court required Mylan to pay $147 million, including $28.2 million to state agencies including Medicaid. To (a) describe the seller concentration in the national Medicaid generic lorazepam market over a 19-year period from January 1991 through December 2009, (b) estimate the excess payments for generic lorazepam by Medicaid between 1998 and 2009, and (c) investigate potentially increased utilization and prices of 2 substitute pharmaceuticals: branded lorazepam (Ativan) and generic alprazolam (another widely used intermediate-acting benzodiazepine). Using Medicaid State Drug Utilization Data from the Centers for Medicare Medicaid Services, we calculated the 4-firm concentration ratio (CR₄) and the Herfindahl-Hirschman Index (HHI) for the Medicaid generic lorazepam market, along with pre-rebate reimbursement for pharmacy claims, number of claims (utilization), and average pre-rebate reimbursement per claim (average "price") for generic lorazepam, from 1991 through 2009. Medicaid's excess payments were estimated under 2 different assumptions regarding what the average generic lorazepam price would have been in the absence of the alleged conspiracy. To find counterfactual prices, the average per-claim reimbursement for lorazepam for the 4 quarters prior to the alleged conspiracy, $6.80, was inflated using (a) the quarterly change in the average per-claim reimbursement for generic alprazolam and (b) the Consumer Price Index (CPI) for all urban consumers, all goods. Potential impact of the alleged conspiracy on the branded lorazepam and generic alprazolam markets was investigated. The average pre-rebate reimbursements per claim for generic lorazepam were $10.25, $23.12, and $8.48 in 1991, 1998, and 2009, respectively. For the same 3 years, CR₄ = 52.80, 76.02, and 86.74, while HHI = 905.71, 2,166.25, and 2,233.36. Medicaid's excess payments from 1998-2009 were estimated at approximately $625-$657 million. The data also suggest the possibility of small impacts on the utilization of branded lorazepam and the price of generic alprazolam. Prior to the alleged conspiracy in 1997, average pre-rebate reimbursement per claim for generic lorazepam was declining, while seller concentration was rising. After a jump in average payment per claim in the years immediately following the alleged conspiracy, prices have gradually returned to their pre-1998 levels. However, the generic lorazepam market was more concentrated in 2009 than prior to the alleged conspiracy. Copyright © 2012, Academy of Managed Care Pharmacy. All rights reserved.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Allaire, Marc, E-mail: allaire@bnl.gov; Moiseeva, Natalia; Botez, Cristian E.
The correlation coefficients calculated between raw powder diffraction profiles can be used to identify ligand-bound/unbound states of lysozyme. The discovery of ligands that bind specifically to a targeted protein benefits from the development of generic assays for high-throughput screening of a library of chemicals. Protein powder diffraction (PPD) has been proposed as a potential method for use as a structure-based assay for high-throughput screening applications. Building on this effort, powder samples of bound/unbound states of soluble hen-egg white lysozyme precipitated with sodium chloride were compared. The correlation coefficients calculated between the raw diffraction profiles were consistent with the known bindingmore » properties of the ligands and suggested that the PPD approach can be used even prior to a full description using stereochemically restrained Rietveld refinement.« less
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Gascón, Fernando; de la Fuente, David; Puente, Javier; Lozano, Jesús
2007-11-01
The aim of this paper is to develop a methodology that is useful for analyzing, from a macroeconomic perspective, the aggregate demand and the aggregate supply features of the market of pharmaceutical generics. In order to determine the potential consumption and the potential production of pharmaceutical generics in different countries, two fuzzy decision support systems are proposed. Two fuzzy decision support systems, both based on the Mamdani model, were applied in this paper. These systems, generated by Matlab Toolbox 'Fuzzy' (v. 2.0), are able to determine the potential of a country for the manufacturing or the consumption of pharmaceutical generics. The systems make use of three macroeconomic input variables. In an empirical application of our proposed methodology, the potential towards consumption and manufacturing in Holland, Sweden, Italy and Spain has been estimated from national indicators. Cross-country comparisons are made and graphical surfaces are analyzed in order to interpret the results. The main contribution of this work is the development of a methodology that is useful for analyzing aggregate demand and aggregate supply characteristics of pharmaceutical generics. The methodology is valid for carrying out a systematic analysis of the potential generics have at a macrolevel in different countries. The main advantages of the use of fuzzy decision support systems in the context of pharmaceutical generics are the flexibility in the construction of the system, the speed in interpreting the results offered by the inference and surface maps and the ease with which a sensitivity analysis of the potential behavior of a given country may be performed.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-30
... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential...: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on... Information Collection request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback...
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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.
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Space Generic Open Avionics Architecture (SGOAA) standard specification
NASA Technical Reports Server (NTRS)
Wray, Richard B.; Stovall, John R.
1994-01-01
This standard establishes the Space Generic Open Avionics Architecture (SGOAA). The SGOAA includes a generic functional model, processing structural model, and an architecture interface model. This standard defines the requirements for applying these models to the development of spacecraft core avionics systems. The purpose of this standard is to provide an umbrella set of requirements for applying the generic architecture models to the design of a specific avionics hardware/software processing system. This standard defines a generic set of system interface points to facilitate identification of critical services and interfaces. It establishes the requirement for applying appropriate low level detailed implementation standards to those interfaces points. The generic core avionics functions and processing structural models provided herein are robustly tailorable to specific system applications and provide a platform upon which the interface model is to be applied.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-08
... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY... (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-22
... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential...; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery... Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency...
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Encouraging the use of generic medicines: implications for transition economies.
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.
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Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know.
Strober, Bruce E; Armour, Katherine; Romiti, Ricardo; Smith, Catherine; Tebbey, Paul W; Menter, Alan; Leonardi, Craig
2012-02-01
The entry of biosimilar forms of biopharmaceutical therapies for the treatment of psoriasis and other immune-mediated disorders has provoked considerable interest. Although dermatologists are accustomed to the use of a wide range of generic topical agents, recognition of key differences between original agent (ie, the name brand) and the generic or biosimilar agent is necessary to support optimal therapy management and patient care. In this review we have summarized the current state of the art related to the impending introduction of biosimilars into dermatology. Biosimilars represent important interventions that are less expensive and hence offer the potential to deliver benefit to large numbers of patients who may not currently be able to access these therapies. But the development of biosimilars is not equivalent to that of small molecule generic therapies because of differences in molecular structure and processes of manufacture. The planned regulatory guidelines and path to approval may not encompass all of these potentially important differences and this may have clinical relevance to the prescriber and patient. Consequently, we have identified a series of key issues that should be considered to support the full potential of biosimilars for the treatment of psoriasis; ie, that of increased access to appropriate therapy for the psoriasis population worldwide. Copyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.
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Discussion meeting on Gossamer spacecraft (ultralightweight spacecraft)
NASA Technical Reports Server (NTRS)
Brereton, R. G. (Editor)
1980-01-01
Concepts, technology, and application of ultralightweight structures in space are examined. Gossamer spacecraft represented a generic class of space vehicles or structures characterized by a low mass per unit area (approximately 50g/m2). Gossamer concepts include the solar sail, the space tether, and various two and three dimensional large lightweight structures that were deployed or assembled in space. The Gossamer Spacecraft had a high potential for use as a transportation device (solar sail), as a science instrument (reflecting or occulting antenna), or as a large structural component for an enclosure, manned platform, or other human habitats. Inflatable structures were one possible building element for large ultralightweight structures in space.
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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.
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2013-01-01
Background Developed countries use generic competition to contain pharmaceutical expenditure. China, as a developing and transitional country, has not yet deemed an increase in the use of generic products as important; otherwise, much effort has been made to decrease the drug prices. This paper aims to explore dynamically the price and use comparison of generic and originator drugs in China, and estimate the potential savings of patients from switching originator drugs to generics. Methods A typical hospital in Chongqing, China, was selected to examine the price and use comparisons of 12 cardiovascular drugs from 2006 to 2011. Results The market share of the 12 generic medicines studied in this paper was 34.37% for volume and 31.33% for value in the second half of 2011. The price ratio of generic to originator drugs was between 0.34 and 0.98, and the volume price index of originators to generics was 1.63. The potential savings of patients from switching originator drugs to generics is 65%. Conclusion The market share of the generics was lowering and the weighted mean price kept increasing in face of the strict price control. Under the background of hospitals both prescribing and dispensing medicines, China’s comprehensive healthcare policy makers should take measures from supply and demand sides to promote the consumption of generic medicines. PMID:24093493
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Small satellite generic bus structure
NASA Astrophysics Data System (ADS)
Fiore, John N.; Summers, George D.
1993-02-01
A 'Smallsat' generic structure has been developed for LEO and expendable launch vehicles. The structure makes extensive use of Al-alloy honeycomb-stabilized panels in order to satisfy stiffness, weight, strength and thermal stability requirements in the LEO environment, in conjunction with discrete applications of multilayered insulation blankets and silverized Teflon radiators. The Smallsat structure is ideally suited for assembly-line manufacturing and storage until required.
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Binary mixtures of condensates in generic confining potentials
NASA Astrophysics Data System (ADS)
Facchi, P.; Florio, G.; Pascazio, S.; Pepe, F. V.
2011-12-01
We study a binary mixture of Bose-Einstein condensates, confined in a generic potential, in the Thomas-Fermi approximation. We search for the zero-temperature ground state of the system, both in the case of fixed numbers of particles and fixed chemical potentials. For generic potentials, we analyze the transition from mixed to separated ground-state configurations as the inter-species interaction increases. We derive a simple formula that enables one to determine the location of the domain walls. Finally, we find criteria for the energetic stability of separated configurations, depending on the number and the position of the domain walls separating the two species.
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Generic Algorithms for Estimating Foliar Pigment Content
NASA Astrophysics Data System (ADS)
Gitelson, Anatoly; Solovchenko, Alexei
2017-09-01
Foliar pigment contents and composition are main factors governing absorbed photosynthetically active radiation, photosynthetic activity, and physiological status of vegetation. In this study the performance of nondestructive techniques based on leaf reflectance were tested for estimating chlorophyll (Chl) and anthocyanin (AnC) contents in species with widely variable leaf structure, pigment content, and composition. Only three spectral bands (green, red edge, and near-infrared) are required for nondestructive Chl and AnC estimation with normalized root-mean-square error (NRMSE) below 4.5% and 6.1%, respectively. The algorithms developed are generic, not requiring reparameterization for each species allowing for accurate nondestructive Chl and AnC estimation using simple handheld field/lab instrumentation. They also have potential in interpretation of airborne and satellite data.
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Dansereau, Richard J; Crail, Debbie J; Perkins, Alan C
2009-02-01
Bisphosphonates as a class have the potential to cause upper gastrointestinal irritation. Although the generic alendronate sodium tablets are bioequivalent to the branded product, a potential concern is that the pharmaceutical attributes of the various generic formulations my affect the potential for local irritation and tolerability. The in vitro disintegration times were determined using the method described in the US Pharmacopeia 30 (USP 30). The disintegration of three generic alendronate sodium tablets 70 mg available in the United States was compared to that of the branded product. The mean disintegration times of the generic alendronate sodium tablets ranged from 9 to 10 s for the Barr lots to 108 s for the Watson lot. The disintegration time of the branded product (Fosamax) was 53 s. The three Barr lots and one Teva lot had rapid disintegration times which were similar to the disintegration standards (< 30 s) for orally disintegrating tablets. Since there is no established disintegration time for alendronate sodium tablets there can be no assurance that the generic tablets are equivalent to the branded product in terms of esophageal exposure. However, the in vitro disintegration times have not been correlated with in vivo disintegration performance. Copies of generic alendronate sodium tablets are approved based on the results of single-dose bioavailability studies in healthy subjects and this is not considered adequate to establish similar disintegration characteristics.
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The Acquisition of Generic Skills of Culturally-Diverse Student Cohorts
ERIC Educational Resources Information Center
Keneley, Monica; Jackling, Beverley
2011-01-01
The changing nature of higher education and the structure of graduate labour markets have increased emphasis on employability and graduate outcomes. Universities have responded to this changed environment by embedding generic skills in the curriculum. This paper examines the generic skills that students perceived they acquired in their accounting…
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Air Force Systems Command Research Planning Guide (Research Objectives).
1987-07-15
potential for producing alloys with superior properties. Titanium and Iron Aluminides - Basic research to identify approaches leading to the formation...performance of ni’.kel, aluminumr,, and titanium alloys and ceramics are required to provide future Air Force weapon systems components with structural...seriously block full exploitat,on. Aluminum and Titanium Alloys - Three generic families of Pylie-,7 alloys are being investigated for both alloy
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ERIC Educational Resources Information Center
Anthony, Angela Beckman
2009-01-01
Basal reading series are used in a majority of classrooms in the United States. The purpose of this study was to examine the frequency of fiction and nonfiction genres included in four recently published first and second grade basal reading series and to compare the frequencies to studies of older basal reading series. Based on the work of…
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ERIC Educational Resources Information Center
Gravesen, Katrine Frovin; Grønbaek, Niels; Winsløw, Carl
2017-01-01
We investigate the challenges students face in the transition from calculus courses, focusing on methods related to the analysis of real valued functions given in closed form, to more advanced courses on analysis where focus is on theoretical structure, including proof. We do so based on task design aiming for a number of generic potentials for…
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Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation
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
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Potential Clinical and Economic Impact of Switching Branded Medications to Generics.
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.
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Potential Clinical and Economic Impact of Switching Branded Medications to Generics
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
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Varni, James W; Limbers, Christine A; Newman, Daniel A; Seid, Michael
2008-11-01
The measurement of health-related quality of life (HRQOL) in pediatric medicine and health services research has grown significantly over the past decade. The paradigm shift toward patient-reported outcomes (PROs) has provided the opportunity to emphasize the value and critical need for pediatric patient self-report. In order for changes in HRQOL/PRO outcomes to be meaningful over time, it is essential to demonstrate longitudinal factorial invariance. This study examined the longitudinal factor structure of the PedsQL 4.0 Generic Core Scales over a one-year period for child self-report ages 5-17 in 2,887 children from a statewide evaluation of the California State Children's Health Insurance Program (SCHIP) utilizing a structural equation modeling framework. Specifying four- and five-factor measurement models, longitudinal structural equation modeling was used to compare factor structures over a one-year interval on the PedsQL 4.0 Generic Core Scales. While the four-factor conceptually-derived measurement model for the PedsQL 4.0 Generic Core Scales produced an acceptable fit, the five-factor empirically-derived measurement model from the initial field test of the PedsQL 4.0 Generic Core Scales produced a marginally superior fit in comparison to the four-factor model. For the five-factor measurement model, the best fitting model, strict factorial invariance of the PedsQL 4.0 Generic Core Scales across the two measurement occasions was supported by the stability of the comparative fit index between the unconstrained and constrained models, and several additional indices of practical fit including the root mean squared error of approximation, the non-normed fit index, and the parsimony normed fit index. The findings support an equivalent factor structure on the PedsQL 4.0 Generic Core Scales over time. Based on these data, it can be concluded that over a one-year period children in our study interpreted items on the PedsQL 4.0 Generic Core Scales in a similar manner.
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Generic maintenance immunosuppression in solid organ transplant recipients.
Ensor, Christopher R; Trofe-Clark, Jennifer; Gabardi, Steven; McDevitt-Potter, Lisa M; Shullo, Michael A
2011-11-01
Survival after solid organ transplantation has increased in the era of tacrolimus and mycophenolate. This increased survival could be due in part to the broad clinical use of these potent and specific agents for maintenance immunosuppression. These drugs have enhanced specificity and potency for T and B lymphocytes compared with their predecessors, cyclosporine and azathioprine. Between 2008 and 2010, the United States Food and Drug Administration approved several generic formulations of both tacrolimus and mycophenolate mofetil. Deciding whether generic products can be safely substituted for the innovator product is a clinical dilemma similar to that which occurred when generic formulations of cyclosporine became available. We describe the concerns regarding generic immunosuppression use, summarize expert opinion and consensus statements in transplantation, analyze the potential impact of generic substitution, and provide estimates of populations affected based on generic drug market penetration. Formulary considerations such as cost, availability, and potential drug ordering and drug selection errors are described, and transplant coordinator and patient perspectives are reviewed. Finally, general recommendations about the use of generic maintenance immunosuppression in solid organ transplant recipients are provided. Although more research is needed to confirm clinical and therapeutic equivalence and pharmacoeconomic benefit, generic immunosuppressants can be safely substituted for innovator products as long as patients consistently receive the same product, patients and clinicians are aware of when substitutions occur, and enhanced therapeutic drug monitoring is provided during the transition.
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Developing competitive and sustainable Polish generic medicines market.
Simoens, Steven
2009-10-01
To descriptively analyze the policy environment surrounding the Polish generic medicines retail market. 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 Poland using IMS Health pharmaceutical intelligence data. Poland has a mature, high-volume, low-value generic medicines market, primarily driven by the establishment of the reference price at the price of the cheapest medicine in combination with pricing regulation and the low level of medicine prices. The practice of discounting in the distribution chain implies that the National Health Fund and patients do not capture the potential savings from a generic medicines market where companies compete on price. This high-volume market has benefited in the past from the limited availability of originator medicines and a short data exclusivity period, even though there are no 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 21%. To develop a competitive and sustainable market, Poland needs to consider moving away from competition by discount to competition by price. This could be achieved by replacing maximum distribution margins by fixed margins. Also, Poland may wish to raise reference prices as a temporary measure to boost market entry for medicine classes with few generic medicines.
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77 FR 27062 - Agency Forms Undergoing Paperwork Reduction Act Review
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-08
... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... Project NIOSH Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery--NEW... Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-13
... proposed sample size, the expected response rate, methods for assessing potential non-response bias, the... Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative...): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' to OMB for...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-22
... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... Qualitative Feedback on Agency Service Delivery AGENCY: National Institute of Mental Health (NIMH), HHS... Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency...
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Federal Register 2010, 2011, 2012, 2013, 2014
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... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... Qualitative Feedback on Agency Service Delivery SUMMARY: As part of a Federal Government-wide effort to... Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-27
... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... Qualitative Feedback on Agency Service Delivery: National Cancer Center (NCI) ACTION: 30-Day notice of... Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency...
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The computational structural mechanics testbed generic structural-element processor manual
NASA Technical Reports Server (NTRS)
Stanley, Gary M.; Nour-Omid, Shahram
1990-01-01
The usage and development of structural finite element processors based on the CSM Testbed's Generic Element Processor (GEP) template is documented. By convention, such processors have names of the form ESi, where i is an integer. This manual is therefore intended for both Testbed users who wish to invoke ES processors during the course of a structural analysis, and Testbed developers who wish to construct new element processors (or modify existing ones).
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Characterizing Learning Environments Capable of Nurturing Generic Capabilities in Higher Education
ERIC Educational Resources Information Center
Kember, David; Leung, Doris Y. P.; Ma, Rosa S. F.
2007-01-01
There has been wide recognition that today's graduates need the type of generic capabilities necessary for lifelong learning. However, the mechanism by which universities can develop these generic skills is not clearly established. This study aimed to investigate the mechanism for their development. Structural equation modeling (SEM) was used to…
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Chao, Jingdong; Skup, Martha; Alexander, Emily; Tundia, Namita; Macaulay, Dendy; Wu, Eric; Mulani, Parvez
2015-03-01
The purpose of the present study was to investigate the traceability of adverse events (AEs) for branded and generic drugs with identical nonproprietary names and to consider potential implications for the traceability of AEs for branded and biosimilar biologics. Adverse event reports in the Food and Drug Administration AE Reporting System (FAERS) were compared with those in a commercial insurance claims database (Truven Health MarketScan(®)) for 2 drugs (levetiracetam and enoxaparin sodium) with manufacturing or prescribing considerations potentially analogous to those of some biosimilars. Monthly rates of branded- and generic-attributed AEs were estimated pre- and post-generic entry. Post-entry branded-to-generic AE relative rate ratios were calculated. In FAERS, monthly AE rate ratios during the post-generic period showed a pattern in which AE rates for the branded products were greater than for the generic products. Differences in rates of brand- and generic-attributed AEs were statistically significant for both study drugs; the AE rate for the branded products peaked at approximately 10 times that of the generic levetiracetam products and approximately 4 times that of the generic enoxaparin sodium products. In contrast, monthly ratios for the MarketScan data were relatively constant over time. Use of the same nonproprietary name for generic and branded products may contribute to poor traceability of AEs reported in the FAERS database due to the significant misattribution of AEs to branded products (when those AEs were in fact associated with patient use of generic products). To ensure accurate and robust safety surveillance and traceability for biosimilar products in the United States, improved product identification mechanisms, such as related but distinguishable nonproprietary names for biosimilars and reference biologics, should be considered.
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NASA Technical Reports Server (NTRS)
Johnson, Charles S.
1986-01-01
It is nearly axiomatic, that to take the greatest advantage of the useful features available in a development system, and to avoid the negative interactions of those features, requires the exercise of a design methodology which constrains their use. A major design support feature of the Ada language is abstraction: for data, functions processes, resources, and system elements in general. Atomic abstract types can be created in packages defining those private types and all of the overloaded operators, functions, and hidden data required for their use in an application. Generically structured abstract types can be created in generic packages defining those structured private types, as buildups from the user-defined data types which are input as parameters. A study is made of the design constraints required for software incorporating either atomic or generically structured abstract types, if the integration of software components based on them is to be subsequently performed. The impact of these techniques on the reusability of software and the creation of project-specific software support environments is also discussed.
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Primary propulsion/large space system interactions
NASA Technical Reports Server (NTRS)
Dergance, R. H.
1980-01-01
Three generic types of structural concepts and nonstructural surface densities were selected and combined to represent potential LSS applications. The design characteristics of various classes of large space systems that are impacted by primary propulsion thrust required to effect orbit transfer were identified. The effects of propulsion system thrust-to-mass ratio, thrust transients, and performance on the mass, area, and orbit transfer characteristics of large space systems were determined.
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Developing Competitive and Sustainable Polish Generic Medicines Market
Simoens, Steven
2009-01-01
Aim To descriptively analyze the policy environment surrounding the Polish generic medicines retail market. Method 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 Poland using IMS Health pharmaceutical intelligence data. Results Poland has a mature, high-volume, low-value generic medicines market, primarily driven by the establishment of the reference price at the price of the cheapest medicine in combination with pricing regulation and the low level of medicine prices. The practice of discounting in the distribution chain implies that the National Health Fund and patients do not capture the potential savings from a generic medicines market where companies compete on price. This high-volume market has benefited in the past from the limited availability of originator medicines and a short data exclusivity period, even though there are no 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 21%. Conclusion To develop a competitive and sustainable market, Poland needs to consider moving away from competition by discount to competition by price. This could be achieved by replacing maximum distribution margins by fixed margins. Also, Poland may wish to raise reference prices as a temporary measure to boost market entry for medicine classes with few generic medicines. PMID:19839067
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Zhao, Wenle; Pauls, Keith
2016-04-01
Centralized outcome adjudication has been used widely in multicenter clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network's data management center within a homegrown clinical trial management system. In this article, the system design strategy and database structure are presented. A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer 1 or 2 days. A total of 7336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84 days from outcome event case report form submission to adjudication procedure completion. A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality. © The Author(s) 2015.
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Gumbs, Pearl D; Verschuren, W M Monique; Souverein, Patrick C; Mantel-Teeuwisse, Aukje K; de Wit, G Ardine; de Boer, Anthonius; Klungel, Olaf H
2007-11-01
To assess the potential annual savings due to generic and therapeutic substitution of statin therapy for the general Dutch population, taking the patients medical history into account. We conducted a population-based costing study using the PHARMO Record Linkage System (RLS). PHARMO RLS contains drug dispensing records from a representative sample of pharmacies located in more than 50 regions in the Netherlands. We selected all statin users in the database since 2003. The cost-savings of generic substitution of statin therapy for all simvastatin and pravastatin users, and of therapeutic substitution of statin therapy for other statin users were calculated. Substituting current users and new users of statins were considered separately. Therapeutic substitution was based on the medical history of the individual patient. Patients were only substituted if there was an appropriate substitute available. The appropriateness of substitution was based on drug-drug interactions between statins and possible comedication and the availability of an equipotent alternative. Substituting (generic and therapeutic) statin therapy for all current users would lead to potential annual savings of approximately 87 million euros. Substituting (generic and therapeutic) all starters on statin therapy would lead to potential annual savings of around 51 million euros. In the case of generic substitution only, the potential annual savings for all current simvastatin and pravastatin users would be 2.4 million euros and for the new users about 1.8 million euros. From an economic point of view, society could gain a lot from substituting statin therapy, especially from therapeutic substitution.
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Composite structural materials
NASA Technical Reports Server (NTRS)
Loewy, R.; Wiberley, S. E.
1986-01-01
Overall emphasis is on basic long-term research in the following categories: constituent materials, composite materials, generic structural elements, processing science technology; and maintaining long-term structural integrity. Research in basic composition, characteristics, and processing science of composite materials and their constituents is balanced against the mechanics, conceptual design, fabrication, and testing of generic structural elements typical of aerospace vehicles so as to encourage the discovery of unusual solutions to present and future problems. Detailed descriptions of the progress achieved in the various component parts of this comprehensive program are presented.
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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.
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Deeply discounted medications: Implications of generic prescription drug wars.
Czechowski, Jessica L; Tjia, Jennifer; Triller, Darren M
2010-01-01
To describe the history of generic prescription pricing programs at major pharmacy chains and their potential implications on prescribing, quality of care, and patient safety. Publicly available generic prescription discount program drug lists as of May 1, 2009. Fierce competition among major pharmacy chains such as Walgreens, CVS, and Walmart has led to a generic prescription pricing war with unclear public health implications. Introduced in 2006, currently 7 of the 10 largest pharmacy chains advertise a version of a deeply discounted medication (DDM) program, accounting for more than 25,000 locations nationally. By early 2008, almost 70 million Americans had used these programs. Although DDM programs lower drug costs for many patients, DDM formularies include potentially ineffective or harmful medications, have the potential to influence physician prescribing behavior, and may impair pharmacists' ability to review complete drug-dispensing records. DDMs are widespread but have the potential for unintended consequences on patients, providers, and the health care system. A systematic review of DDMs needs to evaluate the clinical, economic, and system-level implications of such programs.
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ERIC Educational Resources Information Center
Jalilifar, Alireza; Montazeri, Ebtesam Abbasi
2017-01-01
While identifying the generic structure of academic introductions has been the focus of extensive research over the last few decades, investigating some, if not all, of the available linguistic resources that realize the identified generic structures seems to have been largely under-focused. In order to shed light on the way that the communicative…
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ERIC Educational Resources Information Center
Kirton, Stewart B.; Al-Ahmad, Abdullah; Fergus, Suzanne
2014-01-01
Increase in tuition fees means there will be renewed pressure on universities to provide "value for money" courses that provide extensive training in both subject-specific and generic skills. For graduates of chemistry this includes embedding the generic, practical, and laboratory-based skills associated with industrial research as an…
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Evaluating Multi-Input/Multi-Output Digital Control Systems
NASA Technical Reports Server (NTRS)
Pototzky, Anthony S.; Wieseman, Carol D.; Hoadley, Sherwood T.; Mukhopadhyay, Vivek
1994-01-01
Controller-performance-evaluation (CPE) methodology for multi-input/multi-output (MIMO) digital control systems developed. Procedures identify potentially destabilizing controllers and confirm satisfactory performance of stabilizing ones. Methodology generic and used in many types of multi-loop digital-controller applications, including digital flight-control systems, digitally controlled spacecraft structures, and actively controlled wind-tunnel models. Also applicable to other complex, highly dynamic digital controllers, such as those in high-performance robot systems.
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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...
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Generic Structure of the Blurbs in Pakistani E-Socio-Romantic Novels
ERIC Educational Resources Information Center
Asghar, Zobina Muhammad; Mahmood, Muhammad Asim; Asghar, Samina Ali
2015-01-01
This paper studies the generic move structure of the blurbs of Electronic Socio-romantic novels published in Pakistan. It explores the move schema, the number of moves and their order in different blurbs. It also observes the most focused and the most neglected move in these blurbs. 20 book blurbs have been collected from online source and the…
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NASA Technical Reports Server (NTRS)
Johnson, Charles S.
1986-01-01
The embedded systems running real-time applications, for which Ada was designed, require their own mechanisms for the management of dynamically allocated storage. There is a need for packages which manage their own internalo structures to control their deallocation as well, due to the performance implications of garbage collection by the KAPSE. This places a requirement upon the design of generic packages which manage generically structured private types built-up from application-defined input types. These kinds of generic packages should figure greatly in the development of lower-level software such as operating systems, schedulers, controllers, and device driver; and will manage structures such as queues, stacks, link-lists, files, and binary multary (hierarchical) trees. Controlled to prevent inadvertent de-designation of dynamic elements, which is implicit in the assignment operation A study was made of the use of limited private type, in solving the problems of controlling the accumulation of anonymous, detached objects in running systems. The use of deallocator prodecures for run-down of application-defined input types during deallocation operations during satellites.
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Effect of generic drug competition on the price of prescription drugs in Ontario.
Lexchin, J
1993-01-01
OBJECTIVE: To analyse the potential effect of generic drug competition on prices in Ontario to assess the costs and benefits associated with Bill C-22 (An Act to amend the Patent Act). DESIGN: Comparison of the cost of the least and most expensive versions of all products sold by more than one manufacturer in 1991. The number of brand-name and generic drug companies marketing each of the products was recorded. RESULTS: Of 1599 products 437 (27.3%) were made by more than one company. Almost half (44.6%) of the 437 were sold by two companies. The more companies that sold a drug the greater the difference in price between the least and most expensive versions. Similarly, as the proportion of generic drug companies in competition increased, the greater the price difference. When competition was between generic drug companies only, the price spread was smaller than when it was between brand-name drug companies only. CONCLUSIONS: Generic drug competition can result in savings to the Ontario Drug Benefit Plan. A more in-depth analysis of the potential savings is necessary to fully assess the costs and benefits associated with Bill C-22. PMID:8439888
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Generic medicines and generic substitution: contrasting perspectives of stakeholders in Ireland.
O'Leary, A; Usher, C; Lynch, M; Hall, M; Hemeryk, L; Spillane, S; Gallagher, P; Barry, M
2015-12-15
The Health (Pricing and Supply of Medical Goods) Act 2013 passed into law in July 2013 and legislated for generic substitution in Ireland. The aim of the study was to ascertain the knowledge and perceptions of stakeholders i.e. patients, pharmacists and prescribers, of generic medicines and to generic substitution with the passing of legislation. Three stakeholder specific questionnaires were developed to assess knowledge of and perceptions to generic medicines and generic substitution. Purposive samples of patients, prescribers and pharmacists were analysed. Descriptive quantitative and qualitative analyses were undertaken. A total of 762 healthcare professionals and 353 patients were recruited. The study highlighted that over 84% of patients were familiar with generic medicines and are supportive of the concept of generic substitution. Approximately 74% of prescribers and 84% of pharmacists were supportive of generic substitution in most cases. The main areas of concern highlighted by the healthcare professionals that might impact on the successful implementation of the policy, were the issue of bioequivalence with generic medicines, the computer software systems used at present in general practitioner (GP) surgeries and the availability of branded generics. The findings from this study identify a high baseline rate of acceptance to generic medicines and generic substitution among patients, prescribers and pharmacists in the Irish setting. The concerns of the main stakeholders provide a valuable insight into the potential difficulties that may arise in its implementation, and the need for on-going reassurance and proactive dissemination of the impact of the generic substitution policy. The existing positive attitude to generic medicines and generic substitution among key stakeholders in Ireland to generic substitution, combined with appropriate support and collaboration should result in the desired increase in rates of prescribing, dispensing and use of generic medicines.
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GENERIC Integrators: Structure Preserving Time Integration for Thermodynamic Systems
NASA Astrophysics Data System (ADS)
Öttinger, Hans Christian
2018-04-01
Thermodynamically admissible evolution equations for non-equilibrium systems are known to possess a distinct mathematical structure. Within the GENERIC (general equation for the non-equilibrium reversible-irreversible coupling) framework of non-equilibrium thermodynamics, which is based on continuous time evolution, we investigate the possibility of preserving all the structural elements in time-discretized equations. Our approach, which follows Moser's [1] construction of symplectic integrators for Hamiltonian systems, is illustrated for the damped harmonic oscillator. Alternative approaches are sketched.
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Nondeterministic data base for computerized visual perception
NASA Technical Reports Server (NTRS)
Yakimovsky, Y.
1976-01-01
A description is given of the knowledge representation data base in the perception subsystem of the Mars robot vehicle prototype. Two types of information are stored. The first is generic information that represents general rules that are conformed to by structures in the expected environments. The second kind of information is a specific description of a structure, i.e., the properties and relations of objects in the specific case being analyzed. The generic knowledge is represented so that it can be applied to extract and infer the description of specific structures. The generic model of the rules is substantially a Bayesian representation of the statistics of the environment, which means it is geared to representation of nondeterministic rules relating properties of, and relations between, objects. The description of a specific structure is also nondeterministic in the sense that all properties and relations may take a range of values with an associated probability distribution.
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Optimisation of a Generic Ionic Model of Cardiac Myocyte Electrical Activity
Guo, Tianruo; Al Abed, Amr; Lovell, Nigel H.; Dokos, Socrates
2013-01-01
A generic cardiomyocyte ionic model, whose complexity lies between a simple phenomenological formulation and a biophysically detailed ionic membrane current description, is presented. The model provides a user-defined number of ionic currents, employing two-gate Hodgkin-Huxley type kinetics. Its generic nature allows accurate reconstruction of action potential waveforms recorded experimentally from a range of cardiac myocytes. Using a multiobjective optimisation approach, the generic ionic model was optimised to accurately reproduce multiple action potential waveforms recorded from central and peripheral sinoatrial nodes and right atrial and left atrial myocytes from rabbit cardiac tissue preparations, under different electrical stimulus protocols and pharmacological conditions. When fitted simultaneously to multiple datasets, the time course of several physiologically realistic ionic currents could be reconstructed. Model behaviours tend to be well identified when extra experimental information is incorporated into the optimisation. PMID:23710254
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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.
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Balkhi, Bander; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa
2016-01-01
Despite the cost of pharmaceuticals, studies assessing prices of osteoporosis drugs are lacking. This study examined trends in prices of osteoporosis drugs in the United States in the period 1988-2014, assessed pricing structure of osteoporosis drugs, and evaluated price trends before and after generic drugs market entry. Data were derived from the U.S. Food and Drug Administration, the RedBook, the Centers for Medicare & Medicaid Services, and the Federal Supply Schedule (FSS). Descriptive statistics and segmented linear regression analyses were performed. In the period 1988-2014, osteoporosis drug prices increased faster than the inflation. The average wholesale price (AWP) of generic products at market entry represented 90 percent of the AWP for the corresponding brand. Prices of brand products continued to increase after generic entry. Drug prices showed a significant variation when compared with the brand AWP. The brand wholesale acquisition cost (WAC) was typically set at 83.3 percent of the AWP. Community pharmacies acquired osteoporosis brand drugs at a median of 80.5 percent of the brand AWP. Significant reductions in brand AWP were observed for Medicare Part B (78.5 percent of the brand AWP), generic National Average Drug Acquisition Cost (33.7 percent), and FSS (22.5 percent). There are significant differences in the manufacturer prices, pharmacy acquisition costs and reimbursement rates of osteoporosis drugs. Pharmaceutical companies listed prices are higher than the pharmacy actual estimated acquisitions costs, and the prices used for reimbursement to providers. Generic drugs entry significantly drives down prices; still, prices of branded drugs facing generic competition continued to increase after generic market entry.
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Effects of generic versus non-generic feedback on motor learning in children.
Chiviacowsky, Suzete; Drews, Ricardo
2014-01-01
Non-generic feedback refers to a specific event and implies that performance is malleable, while generic feedback implies that task performance reflects an inherent ability. The present study examined the influences of generic versus non-generic feedback on motor performance and learning in 10-year-old children. In the first experiment, using soccer ball kicking at a target as a task, providing participants with generic feedback resulted in worse performance than providing non-generic feedback, after both groups received negative feedback. The second experiment measured more permanent effects. Results of a retention test, performed one day after practicing a throwing task, showed that participants who received non-generic feedback during practice outperformed the generic feedback group, after receiving a negative feedback statement. The findings demonstrate the importance of the wording of feedback. Even though different positive feedback statements may not have an immediate influence on performance, they can affect performance, and presumably individuals' motivation, when performance is (purportedly) poor. Feedback implying that performance is malleable, rather than due to an inherent ability, seems to have the potential to inoculate learners against setbacks--a situation frequently encountered in the context of motor performance and learning.
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Effects of Generic versus Non-Generic Feedback on Motor Learning in Children
Chiviacowsky, Suzete; Drews, Ricardo
2014-01-01
Non-generic feedback refers to a specific event and implies that performance is malleable, while generic feedback implies that task performance reflects an inherent ability. The present study examined the influences of generic versus non-generic feedback on motor performance and learning in 10-year-old children. In the first experiment, using soccer ball kicking at a target as a task, providing participants with generic feedback resulted in worse performance than providing non-generic feedback, after both groups received negative feedback. The second experiment measured more permanent effects. Results of a retention test, performed one day after practicing a throwing task, showed that participants who received non-generic feedback during practice outperformed the generic feedback group, after receiving a negative feedback statement. The findings demonstrate the importance of the wording of feedback. Even though different positive feedback statements may not have an immediate influence on performance, they can affect performance, and presumably individuals' motivation, when performance is (purportedly) poor. Feedback implying that performance is malleable, rather than due to an inherent ability, seems to have the potential to inoculate learners against setbacks – a situation frequently encountered in the context of motor performance and learning. PMID:24523947
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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.
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The Portuguese generic medicines market: a policy analysis
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
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Head-on collision of multistate ultralight BEC dark matter configurations
NASA Astrophysics Data System (ADS)
Guzmán, F. S.; Avilez, Ana A.
2018-06-01
Density profiles of ultralight Bose-condensate dark matter inferred from numerical simulations of structure formation, ruled by the Gross-Pitaevskii-Poisson (GPP) system of equations, have a core-tail structure. Multistate equilibrium configurations of the GPP system, on the other hand, have a similar core-tail density profile. We now submit these multistate configurations to highly dynamical scenarios and show their potential as providers of appropriate density profiles of structures. We present the simulation of head-on collisions between two equilibrium configurations of the GPP system of equations, including the collision of ground state with multistate configurations. We study the regimes of solitonic and merger behavior and show generic properties of the dynamics of the system, including the relaxation process and attractor density profiles. We show that the merger of multistate configurations has the potential to produce core-tail density profiles, with the core dominated by the ground state and the halo dominated by an additional state.
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NASA Astrophysics Data System (ADS)
Miller, W., Jr.; Li, Q.
2015-04-01
The Wilson and Racah polynomials can be characterized as basis functions for irreducible representations of the quadratic symmetry algebra of the quantum superintegrable system on the 2-sphere, HΨ = EΨ, with generic 3-parameter potential. Clearly, the polynomials are expansion coefficients for one eigenbasis of a symmetry operator L2 of H in terms of an eigenbasis of another symmetry operator L1, but the exact relationship appears not to have been made explicit. We work out the details of the expansion to show, explicitly, how the polynomials arise and how the principal properties of these functions: the measure, 3-term recurrence relation, 2nd order difference equation, duality of these relations, permutation symmetry, intertwining operators and an alternate derivation of Wilson functions - follow from the symmetry of this quantum system. This paper is an exercise to show that quantum mechancal concepts and recurrence relations for Gausian hypergeometrc functions alone suffice to explain these properties; we make no assumptions about the structure of Wilson polynomial/functions, but derive them from quantum principles. There is active interest in the relation between multivariable Wilson polynomials and the quantum superintegrable system on the n-sphere with generic potential, and these results should aid in the generalization. Contracting function space realizations of irreducible representations of this quadratic algebra to the other superintegrable systems one can obtain the full Askey scheme of orthogonal hypergeometric polynomials. All of these contractions of superintegrable systems with potential are uniquely induced by Wigner Lie algebra contractions of so(3, C) and e(2,C). All of the polynomials produced are interpretable as quantum expansion coefficients. It is important to extend this process to higher dimensions.
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Reimbursement of biosimilars in Poland: is there a link to health technology assessment?
Neumann, Dominika; Jabłecka, Anna
2016-12-01
Due to their complex structures, biosimilars are not generics. The differences between them are considered during market authorization processes but remain unclear during reimbursement decision-making. We analyzed the reimbursement of biopharmaceuticals in Poland with an emphasis on biosimilars and compared the health technology assessment (HTA) process with that defined in other countries. Recommendations provided by the Polish HTA organization and those in other countries were included as source documents. The period of interest covered January 2012 to December 2014. The reimbursement process for biosimilars in Poland is the same as that for generics. In contrast to other countries, a HTA is not involved in decision-making in Poland. The short administrative procedure for reimbursement of biosimilars in Poland accelerates the decision-making process; therefore, therapies can be made available to patients more quickly. However, this procedure can potentially lead to underestimation of aspects concerning the effectiveness and safety of biosimilars.
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Phased Array Beamforming and Imaging in Composite Laminates Using Guided Waves
NASA Technical Reports Server (NTRS)
Tian, Zhenhua; Leckey, Cara A. C.; Yu, Lingyu
2016-01-01
This paper presents the phased array beamforming and imaging using guided waves in anisotropic composite laminates. A generic phased array beamforming formula is presented, based on the classic delay-and-sum principle. The generic formula considers direction-dependent guided wave properties induced by the anisotropic material properties of composites. Moreover, the array beamforming and imaging are performed in frequency domain where the guided wave dispersion effect has been considered. The presented phased array method is implemented with a non-contact scanning laser Doppler vibrometer (SLDV) to detect multiple defects at different locations in an anisotropic composite plate. The array is constructed of scan points in a small area rapidly scanned by the SLDV. Using the phased array method, multiple defects at different locations are successfully detected. Our study shows that the guided wave phased array method is a potential effective method for rapid inspection of large composite structures.
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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.
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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
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BRST theory without Hamiltonian and Lagrangian
NASA Astrophysics Data System (ADS)
Lyakhovich, S. L.; Sharapov, A. A.
2005-03-01
We consider a generic gauge system, whose physical degrees of freedom are obtained by restriction on a constraint surface followed by factorization with respect to the action of gauge transformations; in so doing, no Hamiltonian structure or action principle is supposed to exist. For such a generic gauge system we construct a consistent BRST formulation, which includes the conventional BV Lagrangian and BFV Hamiltonian schemes as particular cases. If the original manifold carries a weak Poisson structure (a bivector field giving rise to a Poisson bracket on the space of physical observables) the generic gauge system is shown to admit deformation quantization by means of the Kontsevich formality theorem. A sigma-model interpretation of this quantization algorithm is briefly discussed.
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Policies and perceptions on generic drugs: The case of Greece.
Xanthopoulou, Sofia-Sotiria; Katsaliaki, Korina
2018-01-01
The increase in the consumption of generic drugs to reduce pharmaceutical expenditure is a challenge for many countries, especially during the economic crisis. The purpose of the present study is to review the Greek market of generic drugs and the decisions that shape it, to determine the factors that affect Greek patients' and doctors' attitudes about generic substitution and present a set of measures for all stakeholders based on the findings of the secondary and primary analysis. The study includes (a) an analysis of international and national reports and legislation on drugs policies and (b) a questionnaire survey of 242 hospital patients and 85 doctors regarding their perceptions on generics. A small increase in the volume of generics is recorded, yet not followed by sales value, over the recent years that the measures for promoting generics prescription took effect. Distrust from both patients and doctors was observed toward generics' effectiveness and toward the appropriateness of the regulatory authorities' quality controls. The study presents a structured set of viable measures, applicable to many countries, for promoting generic drug consumption that can lead to economic efficiency without degrading the health care quality.
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Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A
2017-12-01
The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.
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ERIC Educational Resources Information Center
Fillery-Travis, Annette Jayne
2014-01-01
This paper critically engages with the pedagogical design of a generic professional doctorate programme as a framework for creation of actionable knowledge within the practice of both adviser and candidate. Within this exploration the relational dimensions of the adviser-candidate interaction are identified and their potential impact partially…
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GENERIC VERIFICATION PROTOCOL FOR AQUEOUS CLEANER RECYCLING TECHNOLOGIES
This generic verification protocol has been structured based on a format developed for ETV-MF projects. This document describes the intended approach and explain plans for testing with respect to areas such as test methodology, procedures, parameters, and instrumentation. Also ...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Boiti, M.; Pempinelli, F.; Pogrebkov, A. K.
2006-12-15
In the framework of the extended resolvent approach the direct and inverse scattering problems for the nonstationary Schroedinger equation with a potential being a perturbation of the N-soliton potential by means of a generic bidimensional smooth function decaying at large spaces are introduced and investigated. The initial value problem of the Kadomtsev-Petviashvili I equation for a solution describing N wave solitons on a generic smooth decaying background is then linearized, giving the time evolution of the spectral data.
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Zhao, Wenle; Pauls, Keith
2015-01-01
Background Centralized outcome adjudication has been used widely in multi-center clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network’s data management center within a homegrown clinical trial management system. In this paper, the system design strategy and database structure are presented. Methods A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. Results By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer one or two days. A total of 7,336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84 days from outcome event case report form submission to adjudication procedure completion. Conclusions A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality. PMID:26464429
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Abuelkhair, Mohammed; Abdu, Shajahan; Godman, Brian; Fahmy, Sahar; Malmström, Rickard E; Gustafsson, Lars L
2012-02-01
Pharmaceutical expenditure has risen rapidly in Abu Dhabi, resulting in policies surrounding generics. However, various circumstances will reduce potential savings, including pharmacists still being free to dispense either originator or branded generics and be fully reimbursed. To research the changes in utilization patterns of proton pump inhibitors (PPIs) and lipid-lowering drugs before and after combined reforms on generics; and subsequently, calculate potential savings based on 'best practices' among Western European countries. An uncontrolled before-and-after observational study of utilization and expenditure of PPIs, statins and ezetimibe between 2004 and 2010, as well as up to 12 months before the first generic policy, to 1 year after the second generic policy, was carried out. Utilization was converted to defined daily doses (DDDs; 2011 DDDs) and DDDs/1000 inhabitants per day. Expenditure/DDD was calculated for omeprazole and simvastatin. PPI utilization rose by 6.5-fold from 2004 to 2010, principally driven by increased utilization of patent-protected PPIs, although more recently stabilization in esomperazole utilization has occurred. Similar changes were seen for statins. Introduction of best practices would reduce PPI expenditure in 2010 by 32.8 million United Arab Emirates dirham (AED; €6.26 million) and statins by over 27 million AED (€5.15 million). Limited demand-side measures led to increased utilization of patent-protected products in Abu Dhabi following the generic reforms. Successful measures will release considerable resources.
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Generic Medicine Pricing Policies in Europe: Current Status and Impact
Dylst, Pieter; Simoens, Steven
2010-01-01
Generic medicine pricing is an area of national responsibility of European Union countries. This article aims to present the current status and impact of generic medicine pricing policies in ambulatory care in Europe. The study conducts a literature review of policies relating to free-pricing systems, price-regulated systems, price differentiation, price competition and discounts, and tendering procedures; and a survey of European generic medicine pricing policies. Competition from Indian generic medicine manufacturers, European variation in generic medicine prices and competition between generic medicine manufacturers by discount suggest that the potential savings to health care payers and patients from generic medicines are not fully realized in Europe. One way of attaining these savings may be to move away from competition by discount to competition by price. Free-pricing systems may drive medicine prices downwards under specific conditions. In price-regulated systems, regulation may lower prices of originator and generic medicines, but may also remove incentives for additional price reductions beyond those imposed by regulation. To date, little is known about the current status and impact of tendering procedures for medicines in ambulatory care. In conclusion, the European experience suggests that there is not a single approach towards developing generic medicine pricing policies in Europe. PMID:27713264
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Brand loyalty, patients and limited generic medicines uptake.
Costa-Font, Joan; Rudisill, Caroline; Tan, Stefanie
2014-06-01
The sluggish development of European generic drug markets depends heavily on demand side factors, and more specifically, patients' and doctors' loyalty to branded products. Loyalty to originator drugs, to the point where originator prices rise upon generic entry has been described as the 'generics paradox'. Originator loyalty can emerge for a plethora of reasons; including costs, perceptions about quality and physician advice. We know very little about the behavioural underpinnings of brand loyalty from the consumer or patient standpoint. This paper attempts to test the extent to which patients are brand loyal by drawing upon Spain's 2002 Health Barometer survey as it includes questions about consumer acceptance of generics in a country with exceptionally low generic uptake and substitution at the time of the study. Our findings suggest that at least 13% of the population would not accept generics as substitutes to the originator. These results confirm evidence of brand loyalty for a minority. Alongside high levels of awareness of generics, we find that low cost-sharing levels explain consumer brand loyalty but their impact on acceptance of generic substitution is very small. Higher cost-sharing and exempting fewer patients from cost-sharing have the potential to encourage generic acceptance. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
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A Deformable Generic 3D Model of Haptoral Anchor of Monogenean
Teo, Bee Guan; Dhillon, Sarinder Kaur; Lim, Lee Hong Susan
2013-01-01
In this paper, a digital 3D model which allows for visualisation in three dimensions and interactive manipulation is explored as a tool to help us understand the structural morphology and elucidate the functions of morphological structures of fragile microorganisms which defy live studies. We developed a deformable generic 3D model of haptoral anchor of dactylogyridean monogeneans that can subsequently be deformed into different desired anchor shapes by using direct manipulation deformation technique. We used point primitives to construct the rectangular building blocks to develop our deformable 3D model. Point primitives are manually marked on a 2D illustration of an anchor on a Cartesian graph paper and a set of Cartesian coordinates for each point primitive is manually extracted from the graph paper. A Python script is then written in Blender to construct 3D rectangular building blocks based on the Cartesian coordinates. The rectangular building blocks are stacked on top or by the side of each other following their respective Cartesian coordinates of point primitive. More point primitives are added at the sites in the 3D model where more structural variations are likely to occur, in order to generate complex anchor structures. We used Catmull-Clark subdivision surface modifier to smoothen the surface and edge of the generic 3D model to obtain a smoother and more natural 3D shape and antialiasing option to reduce the jagged edges of the 3D model. This deformable generic 3D model can be deformed into different desired 3D anchor shapes through direct manipulation deformation technique by aligning the vertices (pilot points) of the newly developed deformable generic 3D model onto the 2D illustrations of the desired shapes and moving the vertices until the desire 3D shapes are formed. In this generic 3D model all the vertices present are deployed for displacement during deformation. PMID:24204903
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A deformable generic 3D model of haptoral anchor of Monogenean.
Teo, Bee Guan; Dhillon, Sarinder Kaur; Lim, Lee Hong Susan
2013-01-01
In this paper, a digital 3D model which allows for visualisation in three dimensions and interactive manipulation is explored as a tool to help us understand the structural morphology and elucidate the functions of morphological structures of fragile microorganisms which defy live studies. We developed a deformable generic 3D model of haptoral anchor of dactylogyridean monogeneans that can subsequently be deformed into different desired anchor shapes by using direct manipulation deformation technique. We used point primitives to construct the rectangular building blocks to develop our deformable 3D model. Point primitives are manually marked on a 2D illustration of an anchor on a Cartesian graph paper and a set of Cartesian coordinates for each point primitive is manually extracted from the graph paper. A Python script is then written in Blender to construct 3D rectangular building blocks based on the Cartesian coordinates. The rectangular building blocks are stacked on top or by the side of each other following their respective Cartesian coordinates of point primitive. More point primitives are added at the sites in the 3D model where more structural variations are likely to occur, in order to generate complex anchor structures. We used Catmull-Clark subdivision surface modifier to smoothen the surface and edge of the generic 3D model to obtain a smoother and more natural 3D shape and antialiasing option to reduce the jagged edges of the 3D model. This deformable generic 3D model can be deformed into different desired 3D anchor shapes through direct manipulation deformation technique by aligning the vertices (pilot points) of the newly developed deformable generic 3D model onto the 2D illustrations of the desired shapes and moving the vertices until the desire 3D shapes are formed. In this generic 3D model all the vertices present are deployed for displacement during deformation.
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Building generic anatomical models using virtual model cutting and iterative registration.
Xiao, Mei; Soh, Jung; Meruvia-Pastor, Oscar; Schmidt, Eric; Hallgrímsson, Benedikt; Sensen, Christoph W
2010-02-08
Using 3D generic models to statistically analyze trends in biological structure changes is an important tool in morphometrics research. Therefore, 3D generic models built for a range of populations are in high demand. However, due to the complexity of biological structures and the limited views of them that medical images can offer, it is still an exceptionally difficult task to quickly and accurately create 3D generic models (a model is a 3D graphical representation of a biological structure) based on medical image stacks (a stack is an ordered collection of 2D images). We show that the creation of a generic model that captures spatial information exploitable in statistical analyses is facilitated by coupling our generalized segmentation method to existing automatic image registration algorithms. The method of creating generic 3D models consists of the following processing steps: (i) scanning subjects to obtain image stacks; (ii) creating individual 3D models from the stacks; (iii) interactively extracting sub-volume by cutting each model to generate the sub-model of interest; (iv) creating image stacks that contain only the information pertaining to the sub-models; (v) iteratively registering the corresponding new 2D image stacks; (vi) averaging the newly created sub-models based on intensity to produce the generic model from all the individual sub-models. After several registration procedures are applied to the image stacks, we can create averaged image stacks with sharp boundaries. The averaged 3D model created from those image stacks is very close to the average representation of the population. The image registration time varies depending on the image size and the desired accuracy of the registration. Both volumetric data and surface model for the generic 3D model are created at the final step. Our method is very flexible and easy to use such that anyone can use image stacks to create models and retrieve a sub-region from it at their ease. Java-based implementation allows our method to be used on various visualization systems including personal computers, workstations, computers equipped with stereo displays, and even virtual reality rooms such as the CAVE Automated Virtual Environment. The technique allows biologists to build generic 3D models of their interest quickly and accurately.
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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.
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Modified independent modal space control method for active control of flexible systems
NASA Technical Reports Server (NTRS)
Baz, A.; Poh, S.
1987-01-01
A modified independent modal space control (MIMSC) method is developed for designing active vibration control systems for large flexible structures. The method accounts for the interaction between the controlled and residual modes. It incorporates also optimal placement procedures for selecting the optimal locations of the actuators in the structure in order to minimize the structural vibrations as well as the actuation energy. The MIMSC method relies on an important feature which is based on time sharing of a small number of actuators, in the modal space, to control effectively a large number of modes. Numerical examples are presented to illustrate the application of the method to generic flexible systems. The results obtained suggest the potential of the devised method in designing efficient active control systems for large flexible structures.
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Generic medicines: Greek physicians' perceptions and prescribing practices.
Tsiantou, V; Zavras, D; Kousoulakou, H; Geitona, M; Kyriopoulos, J
2009-10-01
The penetration of generic drugs in the Greek pharmaceutical market is placed among the weakest in the EU. The Greek regulatory framework does not systematically support the development of this subsector and physicians are not provided with incentives for prescribing generics. The aim of this study was to investigate the prescribing profile of physicians in Greece with a focus on the factors that influence their decision on generics prescribing. A structured questionnaire was sent by mail to a random national sample of 1463 physicians, stratified by sex, specialty and geographical region. The response rate was 82.3%. Greek physicians have a positive view on generics but they prefer to prescribe the original products. According to our analysis, physician's age and their opinion on generics' efficacy and effectiveness are identified as important determinants of their prescribing decision. The primary reason that could make them change their prescribing habits is the appearance of side-effects. Patients' insurance coverage and income, as well as the drug cost are also referred as factors that influence their prescribing decision. Despite the fact that they do not usually prescribe generics in their clinical practice, they are willing to substitute an original drug by a generic product. Our findings suggest that Greek physicians could be persuaded to prescribe generic medicines, if a generic promotion policy was introduced in the country. To develop such a policy, a set of supply side and demand-side measures should be implemented along with provision of information on generics to physicians during their education and clinical practice.
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Setnik, Beatrice; Cone, Edward J
2016-01-01
Abuse-deterrent formulations are one strategy for mitigating the epidemic of prescription opioid abuse. Regulatory guidance documents describe the requirements for developing abuse-deterrent formulations of novel drugs and formulations; however, they do not address "abuse-deterrence equivalence" for generic formulations. As generics may be produced with different excipients and formulations compared to reference drugs, differences in their properties may impact their abuse-deterrent features. Currently, it is unclear what specific studies are needed to support generic abuse-deterrence claims. This commentary outlines several recommendations on the in vitro and in vivo testing required, including the conditions for conducting a human abuse potential study.
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Method for assigning sites to projected generic nuclear power plants
DOE Office of Scientific and Technical Information (OSTI.GOV)
Holter, G.M.; Purcell, W.L.; Shutz, M.E.
1986-07-01
Pacific Northwest Laboratory developed a method for forecasting potential locations and startup sequences of nuclear power plants that will be required in the future but have not yet been specifically identified by electric utilities. Use of the method results in numerical ratings for potential nuclear power plant sites located in each of the 10 federal energy regions. The rating for each potential site is obtained from numerical factors assigned to each of 5 primary siting characteristics: (1) cooling water availability, (2) site land area, (3) power transmission land area, (4) proximity to metropolitan areas, and (5) utility plans for themore » site. The sequence of plant startups in each federal energy region is obtained by use of the numerical ratings and the forecasts of generic nuclear power plant startups obtained from the EIA Middle Case electricity forecast. Sites are assigned to generic plants in chronological order according to startup date.« less
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Money left on the table: generic drug prices in Canada.
Law, Michael R
2013-02-01
Generic drugs are a major cost-saving opportunity for patients and drug plans. While almost every province has reduced generic drug prices, we have no information on whether these new prices are internationally competitive. Therefore, I compared Canadian prices to those in two other countries. I used 2009 data from the IMS Brogan Canadian CompuScript and PharmaStat databases and studied the 100 most frequently dispensed generic products in Ontario, which has Canada's lowest generic prices. I compared these prices to those in public drug programs in the United States and New Zealand that use tendering. Using these alternative prices, I calculated the potential savings in Ontario. Of the top 100 generic products, 82 were listed on an international formulary. In 90% of cases, generic products were less expensive in other countries. If Ontario had obtained the lowest comparator price for these products, the annual public sector and overall drug expenditure savings would have been $129 million and $245 million, respectively. Further, the province could have publicly paid for all these generic drugs - both public and private - and saved $87 million compared to current public sector expenditures. Even after recent reforms, generic drug prices in Canada remain high by international standards. I found that if Ontario had obtained commonly used generic drugs at international best prices, the province could have publicly paid for all generic drugs and lowered annual expenditures by nearly a quarter-billion dollars. Copyright © 2013 Longwoods Publishing.
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Money Left on the Table: Generic Drug Prices in Canada
Law, Michael R.
2013-01-01
Background: Generic drugs are a major cost-saving opportunity for patients and drug plans. While almost every province has reduced generic drug prices, we have no information on whether these new prices are internationally competitive. Therefore, I compared Canadian prices to those in two other countries. Methods: I used 2009 data from the IMS Brogan Canadian CompuScript and PharmaStat databases and studied the 100 most frequently dispensed generic products in Ontario, which has Canada's lowest generic prices. I compared these prices to those in public drug programs in the United States and New Zealand that use tendering. Using these alternative prices, I calculated the potential savings in Ontario. Results: Of the top 100 generic products, 82 were listed on an international formulary. In 90% of cases, generic products were less expensive in other countries. If Ontario had obtained the lowest comparator price for these products, the annual public sector and overall drug expenditure savings would have been $129 million and $245 million, respectively. Further, the province could have publicly paid for all these generic drugs – both public and private – and saved $87 million compared to current public sector expenditures. Discussion: Even after recent reforms, generic drug prices in Canada remain high by international standards. I found that if Ontario had obtained commonly used generic drugs at international best prices, the province could have publicly paid for all generic drugs and lowered annual expenditures by nearly a quarter-billion dollars. PMID:23968624
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This generic verification protocol provides a detailed method to conduct and report results from a verification test of pesticide application technologies that can be used to evaluate these technologies for their potential to reduce spray drift.
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Economic Impacts of the Generic Drug User Fee Act Fee Structure.
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.
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Perceptions of Adult Males Who Participated in Counseling for Trauma: A Generic Qualitative Study
ERIC Educational Resources Information Center
Pullen, Annette M.
2017-01-01
This generic qualitative inquiry explored the perceptions of adult males regarding their counseling for trauma experiences. Through that exploration, literature was enhanced considering the information processing theory. Individual interviews of 10 men were conducted using semi-structured, open-ended questions. Braun and Clarke's thematic analysis…
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Performance Analysis of GAME: A Generic Automated Marking Environment
ERIC Educational Resources Information Center
Blumenstein, Michael; Green, Steve; Fogelman, Shoshana; Nguyen, Ann; Muthukkumarasamy, Vallipuram
2008-01-01
This paper describes the Generic Automated Marking Environment (GAME) and provides a detailed analysis of its performance in assessing student programming projects and exercises. GAME has been designed to automatically assess programming assignments written in a variety of languages based on the "structure" of the source code and the correctness…
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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…
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-04
... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative... Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork...
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The generic drug user fee amendments: an economic perspective
Berndt, Ernst R; Murphy, Stephen J
2018-01-01
Abstract Since the vast majority of prescription drugs consumed by Americans are off patent (‘generic’), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under GDUFA I, generic manufacturers agreed to pay approximately $300 million in fees each year of the five-year program. In exchange, the US Food and Drug Administration (FDA) committed to performance goals. We describe GDUFA I’s FDA commitments, provisions, goals, and annual fee structure and compare it to that entailed in the authorization and implementation of GDUFA II on October 1, 2017. We explain how user fees required under GDUFA I erected barriers to entry and created scale and scope economies for incumbent manufacturers. Congress changed user fees under GDUFA II in part to lessen these incentives. In order to initiate and sustain user fees under GDUFA legislation, FDA requires the submission of self-reported data on generic manufacturers including domestic and foreign facilities. These data are public and our examination of them provides an unprecedented window into the recent organization of generic drug manufacturers supplying the US market. Our results suggest that generic drug manufacturing is increasingly concentrated and foreign. We discuss the implications of this observed market structure for GDUFA II’s implementation among other outcomes. PMID:29707218
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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.
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Walensky, Rochelle P.; Sax, Paul E.; Nakamura, Yoriko M.; Weinstein, Milton C.; Pei, Pamela P.; Freedberg, Kenneth A.; Paltiel, A. David; Schackman, Bruce R.
2013-01-01
Background US HIV treatment guidelines recommend branded once-daily, one-pill efavirenz/emtricitabine/tenofovir as preferred first-line antiretroviral treatment (ART). With the anticipated approval of generic efavirenz in 2012 in the US, the cost of a once-daily, three-pill alternative (generic efavirenz, generic lamivudine, tenofovir) will decrease, but adherence and virologic suppression may be reduced. Objectives To assess the clinical impact, costs, and cost-effectiveness of the generic-based three-pill regimen compared to the branded, co-formulated regimen. To project the potential national savings in the first year of a switch to generic-based ART. Design Mathematical simulation of HIV disease. Data Sources Published data from US clinical trials and observational cohorts. Target Population HIV-infected patients eligible to start on or switch to an efavirenz-based generic ART regimen. Time Horizon Lifetime, One-year Perspective US health system Interventions No ART (for comparison), Three-pill Generic ART, and Branded ART Outcome Measures Quality-adjusted life expectancy, costs, and incremental cost-effectiveness ratios (ICER, $/quality-adjusted life expectancy [QALY]). Results of Base-Case Analysis Compared to No ART, Generic ART has an ICER of $21,100/QALY. Compared to Generic ART, Branded ART increases lifetime costs by $42,500, and per-person survival gains by 0.37 QALYs, for an ICER of $114,800/QALY. Estimated first-year savings, if all eligible US patients start on or switch to Generic ART, are $920 million. Results of Sensitivity Analysis Most plausible assumptions about Generic ART efficacy and costs lead to Branded ART ICERs >$100,000/QALY. Limitations The efficacy and price reduction associated with generics are unknown; estimates are intended to be conservative. Conclusions Compared to a slightly less effective generic-based regimen, the cost-effectiveness of first-line Branded ART exceeds $100,000/QALY. Generic-based ART in the US could yield substantial budgetary savings to HIV programs. PMID:23318310
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Mechanical forces as information: an integrated approach to plant and animal development
Hernández-Hernández, Valeria; Rueda, Denisse; Caballero, Lorena; Alvarez-Buylla, Elena R.; Benítez, Mariana
2014-01-01
Mechanical forces such as tension and compression act throughout growth and development of multicellular organisms. These forces not only affect the size and shape of the cells and tissues but are capable of modifying the expression of genes and the localization of molecular components within the cell, in the plasma membrane, and in the plant cell wall. The magnitude and direction of these physical forces change with cellular and tissue properties such as elasticity. Thus, mechanical forces and the mesoscopic fields that emerge from their local action constitute important sources of positional information. Moreover, physical and biochemical processes interact in non-linear ways during tissue and organ growth in plants and animals. In this review we discuss how such mechanical forces are generated, transmitted, and sensed in these two lineages of multicellular organisms to yield long-range positional information. In order to do so we first outline a potentially common basis for studying patterning and mechanosensing that relies on the structural principle of tensegrity, and discuss how tensegral structures might arise in plants and animals. We then provide some examples of morphogenesis in which mechanical forces appear to act as positional information during development, offering a possible explanation for ubiquitous processes, such as the formation of periodic structures. Such examples, we argue, can be interpreted in terms of tensegral phenomena. Finally, we discuss the hypothesis of mechanically isotropic points as a potentially generic mechanism for the localization and maintenance of stem-cell niches in multicellular organisms. This comparative approach aims to help uncovering generic mechanisms of morphogenesis and thus reach a better understanding of the evolution and development of multicellular phenotypes, focusing on the role of physical forces in these processes. PMID:24959170
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Mechanical forces as information: an integrated approach to plant and animal development.
Hernández-Hernández, Valeria; Rueda, Denisse; Caballero, Lorena; Alvarez-Buylla, Elena R; Benítez, Mariana
2014-01-01
Mechanical forces such as tension and compression act throughout growth and development of multicellular organisms. These forces not only affect the size and shape of the cells and tissues but are capable of modifying the expression of genes and the localization of molecular components within the cell, in the plasma membrane, and in the plant cell wall. The magnitude and direction of these physical forces change with cellular and tissue properties such as elasticity. Thus, mechanical forces and the mesoscopic fields that emerge from their local action constitute important sources of positional information. Moreover, physical and biochemical processes interact in non-linear ways during tissue and organ growth in plants and animals. In this review we discuss how such mechanical forces are generated, transmitted, and sensed in these two lineages of multicellular organisms to yield long-range positional information. In order to do so we first outline a potentially common basis for studying patterning and mechanosensing that relies on the structural principle of tensegrity, and discuss how tensegral structures might arise in plants and animals. We then provide some examples of morphogenesis in which mechanical forces appear to act as positional information during development, offering a possible explanation for ubiquitous processes, such as the formation of periodic structures. Such examples, we argue, can be interpreted in terms of tensegral phenomena. Finally, we discuss the hypothesis of mechanically isotropic points as a potentially generic mechanism for the localization and maintenance of stem-cell niches in multicellular organisms. This comparative approach aims to help uncovering generic mechanisms of morphogenesis and thus reach a better understanding of the evolution and development of multicellular phenotypes, focusing on the role of physical forces in these processes.
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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.
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Floor vibration evaluations for medical facilities
NASA Astrophysics Data System (ADS)
Himmel, Chad N.
2003-10-01
The structural floor design for new medical facilities is often selected early in the design phase and in renovation projects, the floor structure already exists. Because the floor structure can often have an influence on the location of vibration sensitive medical equipment and facilities, it is becoming necessary to identify the best locations for equipment and facilities early in the design process. Even though specific criteria for vibration-sensitive uses and equipment may not always be available early in the design phase, it should be possible to determine compatible floor structures for planned vibration-sensitive uses by comparing conceptual layouts with generic floor vibration criteria. Relatively simple evaluations of planned uses and generic criteria, combined with on-site vibration and noise measurements early in design phase, can significantly reduce future design problems and expense. Concepts of evaluation procedures and analyses will be presented in this paper. Generic floor vibration criteria and appropriate parameters to control resonant floor vibration and noise will be discussed for typical medical facilities and medical research facilities. Physical, economic, and logistical limitations that affect implementation will be discussed through case studies.
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NASA Workshop on Computational Structural Mechanics 1987, part 2
NASA Technical Reports Server (NTRS)
Sykes, Nancy P. (Editor)
1989-01-01
Advanced methods and testbed/simulator development topics are discussed. Computational Structural Mechanics (CSM) testbed architecture, engine structures simulation, applications to laminate structures, and a generic element processor are among the topics covered.
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On the flavor structure of natural composite Higgs models & top flavor violation
NASA Astrophysics Data System (ADS)
Azatov, Aleksandr; Panico, Giuliano; Perez, Gilad; Soreq, Yotam
2014-12-01
We explore the up flavor structure of composite pseudo Nambu-Goldstone-boson Higgs models, where we focus on the flavor anarchic minimal SO(5) case. We identify the different sources of flavor violation in this framework and emphasise the differences from the anarchic Randall-Sundrum scenario. In particular, the fact that the flavor symmetry does not commute with the symmetries that stabilize the Higgs potential may constrain the flavor structure of the theory. In addition, we consider the interplay between the fine tuning of the model and flavor violation. We find that generically the tuning of this class of models is worsen in the anarchic case due to the contributions from the additional fermion resonances. We show that, even in the presence of custodial symmetry, large top flavor violating rate are naturally expected. In particular, t → cZ branching ratio of order of 10-5 is generic for this class of models. Thus, this framework can be tested in the next run of the LHC as well as in other future colliders. We also find that the top flavor violation is weakly correlated with the increase amount of fine tuning. Finally, other related flavor violation effects, such as t → ch and in the D system, are found to be too small to be observed by the current and near future colliders.
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Wu, Nan; Rathnayaka, Tharangani; Kuroda, Yutaka
2015-10-01
Bioluminescence, the generation of visible light in a living organism, is widely observed in nature, and a large variety of bioluminescent proteins have been discovered and characterized. Luciferase is a generic term for bioluminescent enzymes that catalyze the emission of light through the oxidization of a luciferin (also a generic term). Luciferase are not necessarily evolutionary related and do not share sequence or structural similarities. Some luciferases, such as those from fireflies and Renilla, have been thoroughly characterized and are being used in a wide range of applications in bio-imaging. Gaussia luciferase (GLuc) from the marine copepod Gaussia princeps is the smallest known luciferase, and it is attracting much attention as a potential reporter protein. GLuc identification is relatively recent, and its structure and its biophysical properties remain to be fully characterized. Here, we review the bacterial production of natively folded GLuc with special emphasis on its disulfide bond formation and the re-engineering of its bioluminescence properties. We also compare the bioluminescent properties under a strictly controlled in vitro condition of selected GLuc's variants using extensively purified proteins with native disulfide bonds. Furthermore, we discuss and predict the domain structure and location of the catalytic core based on literature and on bioinformatics analysis. Finally, we review some examples of GLuc's emerging use in biomolecular imaging and biochemical assay systems. Copyright © 2015 Elsevier B.V. All rights reserved.
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Environmental modeling and recognition for an autonomous land vehicle
NASA Technical Reports Server (NTRS)
Lawton, D. T.; Levitt, T. S.; Mcconnell, C. C.; Nelson, P. C.
1987-01-01
An architecture for object modeling and recognition for an autonomous land vehicle is presented. Examples of objects of interest include terrain features, fields, roads, horizon features, trees, etc. The architecture is organized around a set of data bases for generic object models and perceptual structures, temporary memory for the instantiation of object and relational hypotheses, and a long term memory for storing stable hypotheses that are affixed to the terrain representation. Multiple inference processes operate over these databases. Researchers describe these particular components: the perceptual structure database, the grouping processes that operate over this, schemas, and the long term terrain database. A processing example that matches predictions from the long term terrain model to imagery, extracts significant perceptual structures for consideration as potential landmarks, and extracts a relational structure to update the long term terrain database is given.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-22
... justify the proposed sample size, the expected response rate, methods for assessing potential non-response... Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service... Qualitative Feedback on Agency Service Delivery '' for approval under the Paperwork Reduction Act (PRA) (44 U...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-30
... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... of Qualitative Feedback on Agency Service Delivery AGENCY: Architectural and Transportation Barriers...: ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to the Office of...
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The dark side of gendered language: The masculine-generic form as a cause for self-report bias.
Vainapel, Sigal; Shamir, Opher Y; Tenenbaum, Yulie; Gilam, Gadi
2015-12-01
Language reflects sociocultural structures, such as gender, and affects individuals' perceptions and cognitions. In gendered languages, male-inflected parts of speech are generally used for both sexes (i.e., masculine generics), thus proliferating stereotypes, inequality, and misattributions. We hypothesized that masculine-generic inflection in a questionnaire would bias women's reports compared with a gender-neutral inflection (e.g., "he or she"). We tested our prediction using an academic motivation questionnaire. We found that women reported lower task value and intrinsic goal orientation in the masculine-generic form compared with the gender-neutral form, and lower self-efficacy than men in the masculine-generic form. These findings suggest that questionnaires and surveys written in gendered languages or translated into them may contain construct-irrelevant variance that may undermine the validity of their scores' interpretations, thus risking the possibility of false conclusions. (c) 2015 APA, all rights reserved).
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ERIC Educational Resources Information Center
Bacharach, Samuel; Bamberger, Peter
1992-01-01
Survey data from 215 nurses (10 male) and 430 civil engineers (10 female) supported the plausibility of occupation-specific models (positing direct paths between role stressors, antecedents, and consequences) compared to generic models. A weakness of generic models is the tendency to ignore differences in occupational structure and culture. (SK)
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Olivier, C. P., E-mail: colivier@sansa.org.za; Maharaj, S. K., E-mail: smaharaj@sansa.org.za, E-mail: rbharuthram@uwc.ac.za; Bharuthram, R., E-mail: rbharuthram@uwc.ac.za
In a series of papers by Maharaj et al., including “Existence domains of slow and fast ion-acoustic solitons in two-ion space plasmas” [Phys. Plasmas 22, 032313 (2015)], incorrect expressions for the Sagdeev potential are presented. In this paper, we provide the correct expression of the Sagdeev potential. The correct expression was used to generate the numerical results for the above-mentioned series of papers, so that all results and conclusions are correct, despite the wrong Sagdeev potential expressions printed in the papers. The correct expression of the Sagdeev potential presented here is a very useful generic expression in the sense thatmore » a single expression can be used to study nonlinear structures associated with any acoustic mode, despite the fact that the supersonic and subsonic species would vary if solitons associated with different linear modes are studied.« less
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Energy Criterion for the Spectral Stability of Discrete Breathers.
Kevrekidis, Panayotis G; Cuevas-Maraver, Jesús; Pelinovsky, Dmitry E
2016-08-26
Discrete breathers are ubiquitous structures in nonlinear anharmonic models ranging from the prototypical example of the Fermi-Pasta-Ulam model to Klein-Gordon nonlinear lattices, among many others. We propose a general criterion for the emergence of instabilities of discrete breathers analogous to the well-established Vakhitov-Kolokolov criterion for solitary waves. The criterion involves the change of monotonicity of the discrete breather's energy as a function of the breather frequency. Our analysis suggests and numerical results corroborate that breathers with increasing (decreasing) energy-frequency dependence are generically unstable in soft (hard) nonlinear potentials.
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Interacting quantum walkers: two-body bosonic and fermionic bound states
NASA Astrophysics Data System (ADS)
Krapivsky, P. L.; Luck, J. M.; Mallick, K.
2015-11-01
We investigate the dynamics of bound states of two interacting particles, either bosons or fermions, performing a continuous-time quantum walk on a one-dimensional lattice. We consider the situation where the distance between both particles has a hard bound, and the richer situation where the particles are bound by a smooth confining potential. The main emphasis is on the velocity characterizing the ballistic spreading of these bound states, and on the structure of the asymptotic distribution profile of their center-of-mass coordinate. The latter profile generically exhibits many internal fronts.
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Searching for decaying axionlike dark matter from clusters of galaxies.
Riemer-Sørensen, Signe; Zioutas, Konstantin; Hansen, Steen H; Pedersen, Kristian; Dahle, Håkon; Liolios, Anastasios
2007-09-28
We constrain the lifetime of radiatively decaying dark matter in clusters of galaxies inspired by generic Kaluza-Klein axions, which have been invoked as a possible explanation for the solar coronal x-ray emission. These particles can be produced inside stars and remain confined by the gravitational potential of clusters. By analyzing x-ray observations of merging clusters, where gravitational lensing observations have identified massive, baryon poor structures, we derive the first cosmological lifetime constraint on this kind of particles of tau > or = 10(23) sec.
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Is There Evidence to Support Brand to Generic Interchange of the Mycophenolic Acid Products?
Phillips, Karen; Reddy, Prabashni; Gabardi, Steven
2017-02-01
The uptake of generic immunosuppressants lags comparatively to other drug classes, despite that the Food and Drug Administration (FDA) uses identical bioequivalence standards for all drugs. Transplant societies acknowledge the cost savings associated with generic immunosuppressants and support their use following heart, lung, kidney, or bone marrow transplantation. Seven studies of the pharmacokinetics or clinical efficacy of generic mycophenolate mofetil compared to the innovator product are published; all studies and products were ex-United States. Three studies did not demonstrate any pharmacokinetic differences between generic and innovator products in healthy subjects, achieving FDA bioequivalence requirements. Two studies in renal allograft recipients demonstrated no difference in area under the curves between generic and innovator products, and in one, the maximum concentration (Cmax) fell outside the FDA regulatory range. Two studies revealed no difference in acute organ rejection or graft function in renal allograft recipients. Patient surveys indicate that cost is a barrier to immunosuppressant adherence. Generics present a viable method to reduce costs to payers, patients, and health care systems. Adherence to immunosuppressants is crucial to prevent graft failure. An affordable regimen potentially confers greater adherence. Concerns regarding the presumed inferiority of generic immunosuppressants should be assuaged by regulatory requirements for bioequivalency testing, transplant society position statements, and pharmacokinetic and clinical studies.
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GERICOS: A Generic Framework for the Development of On-Board Software
NASA Astrophysics Data System (ADS)
Plasson, P.; Cuomo, C.; Gabriel, G.; Gauthier, N.; Gueguen, L.; Malac-Allain, L.
2016-08-01
This paper presents an overview of the GERICOS framework (GEneRIC Onboard Software), its architecture, its various layers and its future evolutions. The GERICOS framework, developed and qualified by LESIA, offers a set of generic, reusable and customizable software components for the rapid development of payload flight software. The GERICOS framework has a layered structure. The first layer (GERICOS::CORE) implements the concept of active objects and forms an abstraction layer over the top of real-time kernels. The second layer (GERICOS::BLOCKS) offers a set of reusable software components for building flight software based on generic solutions to recurrent functionalities. The third layer (GERICOS::DRIVERS) implements software drivers for several COTS IP cores of the LEON processor ecosystem.
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Impacts of supersymmetric higher derivative terms on inflation models in supergravity
DOE Office of Scientific and Technical Information (OSTI.GOV)
Aoki, Shuntaro; Yamada, Yusuke, E-mail: shun-soccer@akane.waseda.jp, E-mail: yuusuke-yamada@asagi.waseda.jp
2015-07-01
We show the effects of supersymmetric higher derivative terms on inflation models in supergravity. The results show that such terms generically modify the effective kinetic coefficient of the inflaton during inflation if the cut off scale of the higher derivative operators is sufficiently small. In such a case, the η-problem in supergravity does not occur, and we find that the effective potential of the inflaton generically becomes a power type potential with a power smaller than two.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Coleman, Justin
2015-02-01
Seismic isolation (SI) has the potential to drastically reduce seismic response of structures, systems, or components (SSCs) and therefore the risk associated with large seismic events (large seismic event could be defined as the design basis earthquake (DBE) and/or the beyond design basis earthquake (BDBE) depending on the site location). This would correspond to a potential increase in nuclear safety by minimizing the structural response and thus minimizing the risk of material release during large seismic events that have uncertainty associated with their magnitude and frequency. The national consensus standard America Society of Civil Engineers (ASCE) Standard 4, Seismic Analysismore » of Safety Related Nuclear Structures recently incorporated language and commentary for seismically isolating a large light water reactor or similar large nuclear structure. Some potential benefits of SI are: 1) substantially decoupling the SSC from the earthquake hazard thus decreasing risk of material release during large earthquakes, 2) cost savings for the facility and/or equipment, and 3) applicability to both nuclear (current and next generation) and high hazard non-nuclear facilities. Issue: To date no one has evaluated how the benefit of seismic risk reduction reduces cost to construct a nuclear facility. Objective: Use seismic probabilistic risk assessment (SPRA) to evaluate the reduction in seismic risk and estimate potential cost savings of seismic isolation of a generic nuclear facility. This project would leverage ongoing Idaho National Laboratory (INL) activities that are developing advanced (SPRA) methods using Nonlinear Soil-Structure Interaction (NLSSI) analysis. Technical Approach: The proposed study is intended to obtain an estimate on the reduction in seismic risk and construction cost that might be achieved by seismically isolating a nuclear facility. The nuclear facility is a representative pressurized water reactor building nuclear power plant (NPP) structure. Figure 1: Project activities The study will consider a representative NPP reinforced concrete reactor building and representative plant safety system. This study will leverage existing research and development (R&D) activities at INL. Figure 1 shows the proposed study steps with the steps in blue representing activities already funded at INL and the steps in purple the activities that would be funded under this proposal. The following results will be documented: 1) Comparison of seismic risk for the non-seismically isolated (non-SI) and seismically isolated (SI) NPP, and 2) an estimate of construction cost savings when implementing SI at the site of the generic NPP.« less
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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.
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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.
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This generic verification protocol provides a detailed method for conducting and reporting results from verification testing of pesticide application technologies. It can be used to evaluate technologies for their potential to reduce spray drift, hence the term “drift reduction t...
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Jambo, Hugues; Dispas, Amandine; Avohou, Hermane T; André, Sébastien; Hubert, Cédric; Lebrun, Pierre; Ziemons, Éric; Hubert, Philippe
2018-06-05
In this study, we describe the development of a SFC-MS method for the quality control of cannabis plants that could be potentially adulterated with synthetic cannabinoids. Considering the high number of already available synthetic cannabinoids and the high rate of development of novel structures, we aimed to develop a generic method suitable for the analysis of a large panel of substances using seventeen synthetic cannabinoids from multiple classes as model compounds. Firstly, a suitable column was chosen after a screening phase. Secondly, optimal operating conditions were obtained following a robust optimization strategy based on a design of experiments and design space methodology (DoE-DS). Finally, the quantitative performances of the method were assessed with a validation according to the total error approach. The developed method has a run time of 9.4 min. It uses a simple modifier composition of methanol with 2% H 2 O and requires minimal sample preparation. It can chromatographically separate natural cannabinoids (except THC-A and CBD-A) from the synthetics assessed. Also, the use of mass spectrometry provides sensitivity and specificity. Moreover, this quality by design (QbD) approach permits the tuning of the method (within the DS) during routine analysis to achieve a desirable separation since the future compounds that should be analyzed could be unknown. The method was validated for the quantitation of a selected synthetic cannabinoid in fiber-type cannabis matrix over the range of 2.5% - 7.5% (w/w) with LOD value as low as 14.4 ng/mL. This generic method should be easy to implement in customs or QC laboratories in the context of counterfeit drugs tracking. Copyright © 2018 Elsevier B.V. All rights reserved.
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Generic script share and the price of brand-name drugs: the role of consumer choice.
Rizzo, John A; Zeckhauser, Richard
2009-09-01
Pharmaceutical expenditures have grown rapidly in recent decades, and now total nearly 10% of health care costs. Generic drug utilization has risen substantially alongside, from 19% of scripts in 1984 to 47% in 2001, thus tempering expenditure growth through significant direct dollar savings. However, generic drugs may lead to indirect savings as well if their use reduces the average price of those brand-name drugs that are still purchased. Prior work indicates that brand-name producers do not lower their prices in the face of generic competition, and our study confirms that finding. However, prior work is silent on how the mix of consumer choices between generic and brand-name drugs might affect the average price of those brand-name drugs that are purchased. We use a nationally representative panel of data on drug utilization and costs for the years 1996-2001 to examine how the share of an individual's prescriptions filled by generics (generic script share) affects his average out-of-pocket cost for brand-name drugs, and the net cost paid by the insurer. Our principal finding is that a higher generic script share lowers average brand-name prices to consumers, presumably because consumers are more likely to substitute generics when brand-name drugs would cost them more. This effect is substantial: a 10% increase in the consumer's generic script share is associated with a 15.6% decline in the average price paid for brand-name drugs by consumers. This implies that the potential cost savings to consumers from generic substitution are far greater than prior work suggests. In contrast, the percentage reduction in average brand costs to health plans is far smaller, and statistically insignificant.
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ERIC Educational Resources Information Center
Ina-Egbe, Esther Funmilayo
2017-01-01
This study was conducted to examine counselors' experience of providing services to looked-after children in the United Kingdom. The generic qualitative design was used. A purposeful sample of 15 counselors was used and semi-structured interviews were conducted. Interviews were transcribed and analyzed using thematic analysis and constant…
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Validity and Diagnostic Accuracy of Scores from the Autism Diagnostic Observation Schedule-Generic
ERIC Educational Resources Information Center
Reid, Melissa A.
2012-01-01
The purpose of this study was to examine the internal structure, relationships with other variables, and diagnostic accuracy of scores on the Autism Diagnostic Observation Schedule-Generic (ADOS-G; Lord et al., 1999) for the purpose of diagnostic decision-making. Participants were 462 children enrolled in a public school district in the southern…
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NASA thesaurus. Volume 1: Hierarchical listing
NASA Technical Reports Server (NTRS)
1985-01-01
There are 16,835 postable terms and 3,765 nonpostable terms approved for use in the NASA scientific and technical information system in the Hierarchical Listing of the NASA Thesaurus. The generic structure is presented for many terms. The broader term and narrower term relationships are shown in an indented fashion that illustrates the generic structure better than the more widely used BT and NT listings. Related terms are generously applied, thus enhancing the usefulness of the Hierarchical Listing. Greater access to the Hierarchical Listing may be achieved with the collateral use of Volume 2 - Access Vocabulary.
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NASA Thesaurus. Volume 1: Hierarchical listing
NASA Technical Reports Server (NTRS)
1982-01-01
There are 16,713 postable terms and 3,716 nonpostable terms approved for use in the NASA scientific and technical information system in the Hierarchical Listing of the NASA Thesaurus. The generic structure is presented for many terms. The broader term and narrower term relationships are shown in an indented fashion that illustrates the generic structure better than the more widely used BT and NT listings. Related terms are generously applied, thus enhancing the usefulness of the Hierarchical Listing. Greater access to the Hierarchical Listing may be achieved with the collateral use of Volume 2 - Access Vocabulary.
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Generic drug policy in Australia: a community pharmacy perspective
Beecroft, Grahame
2007-01-01
This article provides a commentary, from a community pharmacy perspective, on the policy environment for the pharmacy sector in Australia, with a particular focus on present challenges arising from proposals to achieve substantial PBS cost savings from an anticipated surge of new generic drugs. Some $2 billion of medicines currently on the PBS will come off patent in the next 4 years. This growth comes from a low base where generics currently account for only 15% of the total PBS budget. Remuneration for PBS dispensing is fixed through five year agreements with the government, so trading terms on generics are important for the cross-subsidy of other dispensing activities and professional services. These trading terms (discounts provided by generics suppliers) have become part of the overall cost and revenue structure of pharmacies. Despite these arrangements, generic substitution rates in Australia are lower than in most comparable countries, which the government views as an opportunity to promote generic use. The future of generic drug supply via the PBS is important to allow consumers access to medications at the lowest possible price and to provide space for PBS listing of new and expensive drugs. But considerations of PBS reform need to take account of the role and viability of community pharmacy sector as provider of pharmaceuticals in a timely and efficient manner to Australian residents. PMID:17543112
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A modelling framework to simulate foliar fungal epidemics using functional–structural plant models
Garin, Guillaume; Fournier, Christian; Andrieu, Bruno; Houlès, Vianney; Robert, Corinne; Pradal, Christophe
2014-01-01
Background and Aims Sustainable agriculture requires the identification of new, environmentally responsible strategies of crop protection. Modelling of pathosystems can allow a better understanding of the major interactions inside these dynamic systems and may lead to innovative protection strategies. In particular, functional–structural plant models (FSPMs) have been identified as a means to optimize the use of architecture-related traits. A current limitation lies in the inherent complexity of this type of modelling, and thus the purpose of this paper is to provide a framework to both extend and simplify the modelling of pathosystems using FSPMs. Methods Different entities and interactions occurring in pathosystems were formalized in a conceptual model. A framework based on these concepts was then implemented within the open-source OpenAlea modelling platform, using the platform's general strategy of modelling plant–environment interactions and extending it to handle plant interactions with pathogens. New developments include a generic data structure for representing lesions and dispersal units, and a series of generic protocols to communicate with objects representing the canopy and its microenvironment in the OpenAlea platform. Another development is the addition of a library of elementary models involved in pathosystem modelling. Several plant and physical models are already available in OpenAlea and can be combined in models of pathosystems using this framework approach. Key Results Two contrasting pathosystems are implemented using the framework and illustrate its generic utility. Simulations demonstrate the framework's ability to simulate multiscaled interactions within pathosystems, and also show that models are modular components within the framework and can be extended. This is illustrated by testing the impact of canopy architectural traits on fungal dispersal. Conclusions This study provides a framework for modelling a large number of pathosystems using FSPMs. This structure can accommodate both previously developed models for individual aspects of pathosystems and new ones. Complex models are deconstructed into separate ‘knowledge sources’ originating from different specialist areas of expertise and these can be shared and reassembled into multidisciplinary models. The framework thus provides a beneficial tool for a potential diverse and dynamic research community. PMID:24925323
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The short-term impact of Ontario's generic pricing reforms.
Law, Michael R; Ystma, Alison; Morgan, Steven G
2011-01-01
Canadians pay amongst the highest generic drug prices in the world. In July 2010, the province of Ontario enacted a policy that halved reimbursement for generic drugs from the public drug plan, and substantially lowered prices for private purchases. We quantified the impact of this policy on overall generic drug expenditures in the province, and projected the impact in other provinces had they mimicked this pricing change. We used quarterly prescription generic drug dispensing data from the IMS-Brogan CompuScript Audit. We used the price per unit in both the pre- and post-policy period and two economics price indexes to estimate the expenditure reduction in Ontario. Further, we used the post-policy Ontario prices to estimate the potential reduction in other provinces. We estimate that total expenditure on generic drugs in Ontario during the second half of 2010 was between $181 and $194 million below what would be expected if prices had remained at pre-policy level. Over half of the reduction in spending was due to savings on just 10 generic ingredients. If other provinces had matched Ontario's prices, their expenditures over during the latter half of 2010 would have been $445 million lower. We found that if Ontario's pricing scheme were adopted nationally, overall spending on generic drugs in Canada would drop at least $1.28 billion annually--a 5% decrease in total prescription drug expenditure. Other provinces should seriously consider both changes to their generic drug prices and the use of more competitive bulk purchasing policies.
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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.
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Selegiline shortage: Causes and costs of a generic drug shortage.
Dorsey, E R; Thompson, J P; Dayoub, E J; George, B; Saubermann, L A; Holloway, R G
2009-07-21
In September 2007, shortages of generic selegiline occurred, forcing patients to either switch to more expensive alternatives or forego treatment. We sought to evaluate prescription trends of generic selegiline and to quantify the economic impact of any resulting drug substitution of more expensive alternatives. We analyzed proprietary data from IMS Health on monthly prescriptions in the United States for selegiline and potential substitutes from February 2002 through December 2007. Linear regression was used to predict the number of expected prescriptions after August 2007 had a shortage not occurred. The main outcome measures were the changes in prescriptions filled and the economic impact of drug substitution. Prior to the shortage, total prescriptions filled for generic selegiline decreased 42%, and supply consolidated into one company, Apotex Inc., Toronto, Canada, whose market share increased from 41% to 83%. During the first 4 months of the shortage, Apotex Inc. filled 10,500 fewer prescriptions than projected and other selegiline manufacturers filled 7,400 more than projected for a net shortage of 3,100 prescriptions. The number of branded selegiline capsules filled during this period increased by 1,800 above projections, and 1,300 prescriptions for generic selegiline were not refilled or substituted. The societal cost of substituting generic selegiline with branded capsules was $75,000 over the first 4 months of the shortage. Generic drug shortages carry economic and health implications. Given ongoing consolidation in the generics drug industry, these shortages may become more common and may require heightened regulatory scrutiny of the generic drug industry.
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Hemin as a generic and potent protein misfolding inhibitor
DOE Office of Scientific and Technical Information (OSTI.GOV)
Liu, Yanqin; Carver, John A.; Ho, Lam H.
2014-11-14
Highlights: • Hemin prevents Aβ42, α-synuclein and RCM-κ-casein forming amyloid fibrils. • Hemin inhibits the β-sheet structure formation of Aβ42. • Hemin reduces the cell toxicity caused by fibrillar Aβ42. • Hemin dissociates partially formed Aβ42 fibrils. • Hemin prevents amorphous aggregation by ADH, catalase and γs-crystallin. - Abstract: Protein misfolding causes serious biological malfunction, resulting in diseases including Alzheimer’s disease, Parkinson’s disease and cataract. Molecules which inhibit protein misfolding are a promising avenue to explore as therapeutics for the treatment of these diseases. In the present study, thioflavin T fluorescence and transmission electron microscopy experiments demonstrated that hemin preventsmore » amyloid fibril formation of kappa-casein, amyloid beta peptide and α-synuclein by blocking β-sheet structure assembly which is essential in fibril aggregation. Further, inhibition of fibril formation by hemin significantly reduces the cytotoxicity caused by fibrillar amyloid beta peptide in vitro. Interestingly, hemin degrades partially formed amyloid fibrils and prevents further aggregation to mature fibrils. Light scattering assay results revealed that hemin also prevents protein amorphous aggregation of alcohol dehydrogenase, catalase and γs-crystallin. In summary, hemin is a potent agent which generically stabilises proteins against aggregation, and has potential as a key molecule for the development of therapeutics for protein misfolding diseases.« less
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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.
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Price regulation and generic competition in the pharmaceutical market.
Dalen, Dag Morten; Strøm, Steinar; Haabeth, Tonje
2006-09-01
In March 2003 the Norwegian government implemented yardstick-based price regulation schemes on a selection of drugs subjected to generic competition. The retail price cap, termed the "index price," on a drug (chemical substance) was set equal to the average of the three lowest producer prices on that drug, plus a fixed wholesale and retail margin. This is supposed to lower barriers of entry for generic drugs and to trigger price competition. Using monthly data over the period 1998-2004 for the six drugs (chemical entities) included in the index price system, we estimate a structural model enabling us to examine the impact of the reform on both demand and market power. Our results suggest that the index price helped to increase the market shares of generic drugs and succeeded in triggering price competition.
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Structures, performance, benefit, cost study. [gas turbine engines
NASA Technical Reports Server (NTRS)
Feder, E.
1981-01-01
Aircraft engine structures were studied to identify the advanced structural technologies that would provide the most benefits to future aircraft operations. A series of studies identified engine systems with the greatest potential for improvements. Based on these studies, six advanced generic structural concepts were selected and conceptually designed. The benefits of each concept were quantitatively assessed in terms of thrust specific fuel consumption, weight, cost, maintenance cost, fuel burned and direct operating cost plus interest. The probability of success of each concept was also determined. The concepts were ranked and the three most promising were selected for further study which consisted of identifying and comprehensively outlining the advanced technologies required to develop these concepts for aircraft engine application. Analytic, fabrication, and test technology developments are required. The technology programs outlined emphasize the need to provide basic, fundamental understanding of technology to obtain the benefit goals.
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Leveraging consumer's behaviour to promote generic drugs in Italy.
Zerbini, Cristina; Luceri, Beatrice; Vergura, Donata Tania
2017-04-01
The aim of this study was to fill the lack of knowledge regarding a more grounded exploration of the consumer's decision-making process in the context of generic drugs. In this perspective, a model, within the theoretical framework of the Theory of Planned Behaviour (TPB), for studying the consumers' purchase intention of generic drugs was developed. An online survey on 2,222 Italian people who bought drugs in the past was conducted. The proposed model was tested through structural equation modelling (SEM). Almost all the constructs considered in the model, except the perceived behavioural control, contribute to explain the consumer's purchase intention of generic drugs, after controlling for demographic variables (age, income, education). Specifically, attitude, subjective norm, past behaviour, self-identity and trust in the pharmacist have a positive influence on the intention to buy generic drugs. On the contrary, perceived risk towards products and brand sensitivity act negatively. The results of the present study could be useful to public policy makers in developing effective policies and educational campaigns aimed at promoting generic drugs. Specifically, marketing efforts should be directed to inform consumers about the generic drugs' characteristics to mitigate the perceived risk towards these products and to raise awareness during their decision-making process. Copyright © 2017 Elsevier B.V. All rights reserved.
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A Generic Approach for Pen-Based User Interface Development
NASA Astrophysics Data System (ADS)
Macé, Sébastien; Anquetil, Éric
Pen-based interaction is an intuitive way to realize hand drawn structured documents, but few applications take advantage of it. Indeed, the interpretation of the user hand drawn strokes in the context of document is a complex problem. In this paper, we propose a new generic approach to develop such systems based on three independent components. The first one is a set of graphical and editing functions adapted to pen interaction. The second one is a rule-based formalism that models structured document composition and the corresponding interpretation process. The last one is a hand drawn stroke analyzer that is able to interpret strokes progressively, directly while the user is drawing. We highlight in particular the human-computer interaction induced from this progressive interpretation process. Thanks to this generic approach, three pen-based system prototypes have already been developed, for musical score editing, for graph editing, and for UML class diagram editing
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-19
... conduct or sponsor, and that a person is not required to respond to, a collection of information unless it... Non-Routine Emergency Generic Problems. 3. Current OMB approval number: 3150-0012. 4. The form number... possible non-routine generic problems which would require prompt action from the NRC to preclude potential...
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Unified theory of nonlinear electrodynamics and gravity
DOE Office of Scientific and Technical Information (OSTI.GOV)
Torres-Gomez, Alexander; Krasnov, Kirill; Scarinci, Carlos
2011-01-15
We describe a class of unified theories of electromagnetism and gravity. The Lagrangian is of the BF type, with a potential for the B field, the gauge group is U(2) (complexified). Given a choice of the potential function the theory is a deformation of (complex) general relativity and electromagnetism, and describes just two propagating polarizations of the graviton and two of the photon. When gravity is switched off the theory becomes the usual nonlinear electrodynamics with a general structure function. The Einstein-Maxwell theory can be recovered by sending some of the parameters of the defining potential to zero, but formore » any generic choice of the potential the theory is indistinguishable from Einstein-Maxwell at low energies. A real theory is obtained by imposing suitable reality conditions. We also study the spherically-symmetric solution and show how the usual Reissner-Nordstrom solution is recovered.« less
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Effects of generic language on category content and structure.
Gelman, Susan A; Ware, Elizabeth A; Kleinberg, Felicia
2010-11-01
We hypothesized that generic noun phrases ("Bears climb trees") would provide important input to children's developing concepts. In three experiments, four-year-olds and adults learned a series of facts about a novel animal category, in one of three wording conditions: generic (e.g., "Zarpies hate ice cream"), specific-label (e.g., "This zarpie hates ice cream"), or no-label (e.g., "This hates ice cream"). Participants completed a battery of tasks assessing the extent to which they linked the category to the properties expressed, and the extent to which they treated the category as constituting an essentialized kind. As predicted, for adults, generics training resulted in tighter category-property links and more category essentialism than both the specific-label and no-label training. Children also showed effects of generic wording, though the effects were weaker and required more extensive input. We discuss the implications for language-thought relations, and for the acquisition of essentialized categories. Copyright 2010 Elsevier Inc. All rights reserved.
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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.
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ERIC Educational Resources Information Center
Brandone, Amanda C.; Gelman, Susan A.
2013-01-01
The goal of the present study was to explore domain differences in young children's expectations about the structure of animal and artifact categories. We examined 5-year-olds' and adults' use of category-referring generic noun phrases (e.g., "Birds fly") about novel animals and artifacts. The same stimuli served as both animals and artifacts;…
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Promoting and regulating generic medicines: Brazil in comparative perspective.
da Fonseca, Elize Massard; Shadlen, Kenneth C
2017-04-20
Promoting the use of generic drugs can constitute a core instrument for countries' national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap for determining which dimensions of generic drug policy to assess and compare. This report fills that gap by considering national rules and regulations across four dimensions deemed crucial to any evaluation: demonstrated therapeutic equivalence; pharmaceutical packaging and labeling; drug prescription; and drug substitution. Furthermore, this report examines how the diverse interests of public and private sector stakeholders might shape generic drug policy and its implementation. To illustrate the challenges and conflicts behind policy development and implementation, this report focuses on the case of Brazil.
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Westerman, Michiel; Teunissen, Pim W; Fokkema, Joanne P I; van der Vleuten, Cees P M; Scherpbier, Albert J J A; Siegert, Carl E H; Scheele, Fedde
2013-04-01
Insight into the transition from specialist registrar to hospital consultant is needed to better align specialty training with starting as a consultant and to facilitate this transition. This study investigates whether preparedness regarding medical and generic competencies, perceived intensity, and social support are associated with burnout among new consultants. A population-based study among all 2643 new consultants in the Netherlands (all specialties) was conducted in June 2010. A questionnaire covering preparedness for practice, intensity of the transition, social support, and burnout was used. Structural equation modelling was used for statistical analysis. Data from a third of the population were available (32% n = 840) (43% male/57% female). Preparation in generic competencies received lower ratings than in medical competencies. A total of 10% met the criteria for burnout and 18% scored high on the emotional exhaustion subscale. Perceived lack of preparation in generic competencies correlated with burnout (r = 0.15, p < 0.001). No such relation was found for medical competencies. Furthermore, social support protected against burnout. These findings illustrate the relevance of generic competencies for new hospital consultants. Furthermore, social support facilitates this intense and stressful stage within the medical career.
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NASA Astrophysics Data System (ADS)
Wray, Richard B.
1991-12-01
A hybrid requirements analysis methodology was developed, based on the practices actually used in developing a Space Generic Open Avionics Architecture. During the development of this avionics architecture, a method of analysis able to effectively define the requirements for this space avionics architecture was developed. In this methodology, external interfaces and relationships are defined, a static analysis resulting in a static avionics model was developed, operating concepts for simulating the requirements were put together, and a dynamic analysis of the execution needs for the dynamic model operation was planned. The systems engineering approach was used to perform a top down modified structured analysis of a generic space avionics system and to convert actual program results into generic requirements. CASE tools were used to model the analyzed system and automatically generate specifications describing the model's requirements. Lessons learned in the use of CASE tools, the architecture, and the design of the Space Generic Avionics model were established, and a methodology notebook was prepared for NASA. The weaknesses of standard real-time methodologies for practicing systems engineering, such as Structured Analysis and Object Oriented Analysis, were identified.
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NASA Technical Reports Server (NTRS)
Wray, Richard B.
1991-01-01
A hybrid requirements analysis methodology was developed, based on the practices actually used in developing a Space Generic Open Avionics Architecture. During the development of this avionics architecture, a method of analysis able to effectively define the requirements for this space avionics architecture was developed. In this methodology, external interfaces and relationships are defined, a static analysis resulting in a static avionics model was developed, operating concepts for simulating the requirements were put together, and a dynamic analysis of the execution needs for the dynamic model operation was planned. The systems engineering approach was used to perform a top down modified structured analysis of a generic space avionics system and to convert actual program results into generic requirements. CASE tools were used to model the analyzed system and automatically generate specifications describing the model's requirements. Lessons learned in the use of CASE tools, the architecture, and the design of the Space Generic Avionics model were established, and a methodology notebook was prepared for NASA. The weaknesses of standard real-time methodologies for practicing systems engineering, such as Structured Analysis and Object Oriented Analysis, were identified.
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NASA Astrophysics Data System (ADS)
Mir, Mehedi Faruk; Muktadir Rahman, Md.; Dwaipayan, Debnath; Sakhawat Hossain Himel, Md.
2016-04-01
Energy fluctuation of ideal Fermi gas trapped under generic power law potential U=\\sumi=1d ci \\vertxi/ai \\vert n_i has been calculated in arbitrary dimensions. Energy fluctuation is scrutinized further in the degenerate limit μ ≫ KBT with the help of Sommerfeld expansion. The dependence of energy fluctuation on dimensionality and power law potential is studied in detail. Most importantly our general result can not only exactly reproduce the recently published result regarding free and harmonically trapped ideal Fermi gas in d = 3 but also can describe the outcome for any power law potential in arbitrary dimension.
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Comparison of Compounded, Generic, and Innovator-Formulated Itraconazole in Dogs and Cats.
Renschler, Janelle; Albers, Amanda; Sinclair-Mackling, Hanna; Wheat, Lawrence Joseph
2018-05-14
The triazole antifungal itraconazole may be cost prohibitive in brand name form; therefore, compounded and generic products are often used as alternatives. Itraconazole blood concentrations have not been studied in clinical patients receiving these formulations. Itraconazole bioassay was performed on serum/plasma from 95 dogs and 20 cats receiving itraconazole (compounded from bulk powder, generic pelletized, or brand name) for systemic mycosis treatment. Mean itraconazole concentration was lower in the compounded group (n = 42) as compared with the generic (n = 40) or brand name (n = 33) groups (0.5 µg/mL versus 8.3 µg/mL and 6.5 µg/mL, respectively; P < .001). No statistical difference was observed between itraconazole concentrations in the generic and brand name groups. Forty animals (95.2%) in the compounded group had subtherapeutic (<1.0 µg/mL) values. All cats in this group (n = 10) had undetectable itraconazole concentrations. Some animals in the generic and brand name groups had subtherapeutic values (12.5 and 12.1%, respectively) or potentially toxic values (>10 µg/mL; 37.5 and 24%, respectively). Compounded itraconazole should be avoided, but generic itraconazole appears to serve as a reasonable alternative to brand name itraconazole. Therapeutic drug monitoring may be beneficial in all cases.
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Sun, Dajun; Rouse, Rodney; Patel, Vikram; Wu, Yong; Zheng, Jiwen; Karmakar, Alokita; Patri, Anil K.; Keire, David; Ma, Jia; Jiang, Wenlei
2018-01-01
The objective of this study was to evaluate physicochemical equivalence between brand (i.e., Ferrlecit) and generic sodium ferric gluconate (SFG) in sucrose injection by conducting a series of comparative in vitro characterizations using advanced analytical techniques. The elemental iron and carbon content, thermal properties, viscosity, particle size, zeta potential, sedimentation coefficient, and molecular weight were determined. There was no noticeable difference between brand and generic SFG in sucrose injection for the above physical parameters evaluated, except for the sedimentation coefficient determined by sedimentation velocity analytical ultracentrifugation (SV-AUC) and molecular weight by asymmetric field flow fractionation-multi-angle light scattering (AFFF-MALS). In addition, brand and generic SFG complex products showed comparable molecular weight distributions when determined by gel permeation chromatography (GPC). The observed minor differences between brand and generic SFG, such as sedimentation coefficient, do not impact their biological activities in separate studies of in vitro cellular uptake and rat biodistribution. Coupled with the ongoing clinical study comparing the labile iron level in healthy volunteers, the FDA-funded post-market studies intended to illustrate comprehensive surveillance efforts ensuring safety and efficacy profiles of generic SFG complex in sucrose injection, and also to shed new light on the approval standards on generic parenteral iron colloidal products. PMID:29303999
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Generic Kalman Filter Software
NASA Technical Reports Server (NTRS)
Lisano, Michael E., II; Crues, Edwin Z.
2005-01-01
The Generic Kalman Filter (GKF) software provides a standard basis for the development of application-specific Kalman-filter programs. Historically, Kalman filters have been implemented by customized programs that must be written, coded, and debugged anew for each unique application, then tested and tuned with simulated or actual measurement data. Total development times for typical Kalman-filter application programs have ranged from months to weeks. The GKF software can simplify the development process and reduce the development time by eliminating the need to re-create the fundamental implementation of the Kalman filter for each new application. The GKF software is written in the ANSI C programming language. It contains a generic Kalman-filter-development directory that, in turn, contains a code for a generic Kalman filter function; more specifically, it contains a generically designed and generically coded implementation of linear, linearized, and extended Kalman filtering algorithms, including algorithms for state- and covariance-update and -propagation functions. The mathematical theory that underlies the algorithms is well known and has been reported extensively in the open technical literature. Also contained in the directory are a header file that defines generic Kalman-filter data structures and prototype functions and template versions of application-specific subfunction and calling navigation/estimation routine code and headers. Once the user has provided a calling routine and the required application-specific subfunctions, the application-specific Kalman-filter software can be compiled and executed immediately. During execution, the generic Kalman-filter function is called from a higher-level navigation or estimation routine that preprocesses measurement data and post-processes output data. The generic Kalman-filter function uses the aforementioned data structures and five implementation- specific subfunctions, which have been developed by the user on the basis of the aforementioned templates. The GKF software can be used to develop many different types of unfactorized Kalman filters. A developer can choose to implement either a linearized or an extended Kalman filter algorithm, without having to modify the GKF software. Control dynamics can be taken into account or neglected in the filter-dynamics model. Filter programs developed by use of the GKF software can be made to propagate equations of motion for linear or nonlinear dynamical systems that are deterministic or stochastic. In addition, filter programs can be made to operate in user-selectable "covariance analysis" and "propagation-only" modes that are useful in design and development stages.
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Hill, Andrew; Gotham, Dzintars; Cooke, Graham; Bhagani, Sanjay; Andrieux-Meyer, Isabelle; Cohn, Jennifer; Fortunak, Joseph
2015-04-01
In 2013, an estimated 686,000 people died from hepatitis B virus (HBV) infection worldwide. Mass treatment programmes for hepatitis B will require very low drug costs. International treatment guidelines recommend first-line monotherapy with either entecavir or tenofovir disoproxil fumarate (TDF). While the basic patent on TDF expires in 2017/8, entecavir is already generic in several countries, including the US. The chemical structure of entecavir is related to abacavir, which costs <$200 per person-year in low-income countries. The clinical efficacy, chemical structures, daily doses, routes of chemical synthesis, costs of raw materials and patent expiry dates were analysed for entecavir and TDF. Costs of sustainable, generic production were calculated for entecavir, and compared with published originator and generic prices in high- and low-income countries. With a daily dose of 0.5 mg, one year's supply of entecavir treatment requires <0.2 g of active pharmaceutical ingredient (API) per person, estimated to cost $4/year, based on quotations of API production from generic suppliers. With an additional $20 per year for formulation/packaging and a 50% profit margin, entecavir was estimated to cost a minimum of $36/person-year, substantially lower than current originator and generic prices. Entecavir is no longer under patent protection in the USA, China, Brazil and South Africa, with European expiry in 2017. Given differences in daily dosing, production volumes for entecavir would be 600 times lower than TDF (300 mg once daily) for treating the same numbers of patients. Mass treatment for hepatitis B with generic entecavir could be achieved at very low cost in all countries, provided that important projections can be met in terms of pricing for the API and finished dosage form.
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THE PRACTICE OF STRUCTURE ACTIVITY RELATIONSHIPS (SAR) IN TOXICOLOGY
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...
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Failure behavior of generic metallic and composite aircraft structural components under crash loads
NASA Technical Reports Server (NTRS)
Carden, Huey D.; Robinson, Martha P.
1990-01-01
Failure behavior results are presented from crash dynamics research using concepts of aircraft elements and substructure not necessarily designed or optimized for energy absorption or crash loading considerations. To achieve desired new designs incorporating improved energy absorption capabilities often requires an understanding of how more conventional designs behave under crash loadings. Experimental and analytical data are presented which indicate some general trends in the failure behavior of a class of composite structures including individual fuselage frames, skeleton subfloors with stringers and floor beams without skin covering, and subfloors with skin added to the frame-stringer arrangement. Although the behavior is complex, a strong similarity in the static/dynamic failure behavior among these structures is illustrated through photographs of the experimental results and through analytical data of generic composite structural models.
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A comparative analysis of generics markets in five European countries.
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.
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The Short-Term Impact of Ontario's Generic Pricing Reforms
Law, Michael R.; Ystma, Alison; Morgan, Steven G.
2011-01-01
Background Canadians pay amongst the highest generic drug prices in the world. In July 2010, the province of Ontario enacted a policy that halved reimbursement for generic drugs from the public drug plan, and substantially lowered prices for private purchases. We quantified the impact of this policy on overall generic drug expenditures in the province, and projected the impact in other provinces had they mimicked this pricing change. Methods We used quarterly prescription generic drug dispensing data from the IMS-Brogan CompuScript Audit. We used the price per unit in both the pre- and post-policy period and two economics price indexes to estimate the expenditure reduction in Ontario. Further, we used the post-policy Ontario prices to estimate the potential reduction in other provinces. Results We estimate that total expenditure on generic drugs in Ontario during the second half of 2010 was between $181 and $194 million below what would be expected if prices had remained at pre-policy level. Over half of the reduction in spending was due to savings on just 10 generic ingredients. If other provinces had matched Ontario's prices, their expenditures over during the latter half of 2010 would have been $445 million lower. Discussion We found that if Ontario's pricing scheme were adopted nationally, overall spending on generic drugs in Canada would drop at least $1.28 billion annually—a 5% decrease in total prescription drug expenditure. Other provinces should seriously consider both changes to their generic drug prices and the use of more competitive bulk purchasing policies. PMID:21829581
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Generic and therapeutic statin switches and disruptions in therapy.
Chapman, Richard H; Benner, Joshua S; Girase, Prafulla; Benigno, Michael; Axelsen, Kirsten; Liu, Larry Z; Nichol, Michael B
2009-05-01
The study objective was to compare dose-equivalence, adherence and subsequent switch rates among patients recently switched from a branded to generic version of the same statin (generic substitution, GS) vs. those switched from branded statin to generic version of a different statin (therapeutic substitution, TS). In a retrospective cohort analysis among adult enrollees in over 90 US health plans, the authors identified adult patients who switched from a branded to generic statin from July-December 2006 (simvastatin became generic in June 2006). Patients were classified by type of statin switch: GS (e.g., branded simvastatin --> generic simvastatin), and TS (e.g., branded atorvastatin --> generic simvastatin). Demographic and clinical data were collected from claims before switch through 6 months follow-up. Separate outcomes of interest included proportion of patients that switched to a less potent daily dose, that switched back to previous branded statin after switch, and that were at least 80% adherent during the 6 months after initial switch. Significant predictors of each clinical outcome were identified using multivariable logistic regression models, adjusting for differences between groups in covariates and potential confounders. The 6-month TS (n = 3807) and GS (n = 40,165) groups were generally similar demographically. Compared to GS, TS patients were significantly more likely to be switched to a less potent dose (26.2% vs. 0.5%, adjusted odds ratio [AOR] in patients with high-potency index medication = 83.4, p < 0.0001); 33% less likely to be adherent in the 6 months after switch (67.7% vs. 75.9%, AOR in patients with no switch in first 6 months follow-up = 0.67, p < 0.0001); and four times more likely to switch back to previous branded statin (11.3% vs. 2.9%, AOR = 4.1, p < 0.0001). This study did not account for co-payment changes, lipid measurements, or changes in pill burden. While this study did not have data on why patients had TS (e.g., for cost or clinical reasons), TS was more likely to involve a subsequent disruption to statin therapy than GS. TS could potentially lead to adverse impacts on patients' outcomes, and should be studied further.
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Vortical flow management techniques
NASA Technical Reports Server (NTRS)
Rao, Dhanvada M.; Campbell, James F.
1987-01-01
The aerodynamic performance and controllability of advanced, highly maneuverable supersonic aircraft can be enhanced by means of 'vortex management', which refers to the purposeful manipulation and reordering of stable and concentrated vortical structures due to flow separations from highly swept leading edges and slender forebodies at moderate-to-high angles-of-attack. Attention is presently given to a variety of results obtained in the course of experiments on generic research models at NASA Langley, clarifying their underlying aerodynamics and evaluating their performance-improvement potential. The vortex-management concepts discussed encompass aerodynamic compartmentation of highly swept leading edges, vortex lift augmentation and modulation, and forebody vortex manipulation.
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National Space Transportation and Support Study/technology requirements and plans
NASA Technical Reports Server (NTRS)
Walberg, G. D.; Gasperich, F. J., Jr.; Scheyhing, E. R.
1986-01-01
This paper presents a generic technology plan which has been developed as part of the National Space Transportation and Support Study. This program, which addresses a wide variety of potentially high payoff technology areas, is structured to promote both enhanced vehicle performance and greatly improved operational efficiency and includes both evolutionary and breakthrough technologies. The plan is presented in terms of disciplinary plan elements, which were developed by joint NASA/USAF disciplinary working groups, and as a set of demonstration projects which serve as focal points for the overall plan and drive the development of the many interrelated disciplinary activities.
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NASA thesaurus. Volume 1: Hierarchical Listing
NASA Technical Reports Server (NTRS)
1988-01-01
There are over 17,000 postable terms and nearly 4,000 nonpostable terms approved for use in the NASA scientific and technical information system in the Hierarchical Listing of the NASA Thesaurus. The generic structure is presented for many terms. The broader term and narrower term relationships are shown in an indented fashion that illustrates the generic structure better than the more widely used BT and NT listings. Related terms are generously applied, thus enhancing the usefulness of the Hierarchical Listing. Greater access to the Hierarchical Listing may be achieved with the collateral use of Volume 2 - Access Vocabulary and Volume 3 - Definitions.
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Genericness of inflation in isotropic loop quantum cosmology.
Date, Ghanashyam; Hossain, Golam Mortuza
2005-01-14
Nonperturbative corrections from loop quantum cosmology (LQC) to the scalar matter sector are already known to imply inflation. We prove that the LQC modified scalar field generates exponential inflation in the small scale factor regime, for all positive definite potentials, independent of initial conditions and independent of ambiguity parameters. For positive semidefinite potentials it is always possible to choose, without fine-tuning, a value of one of the ambiguity parameters such that exponential inflation results, provided zeros of the potential are approached at most as a power law in the scale factor. In conjunction with the generic occurrence of bounce at small volumes, particle horizon is absent, thus eliminating the horizon problem of the standard big bang model.
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Medicare Part D payments for neurologist-prescribed drugs
Burke, James F.; Kerber, Kevin A.; Skolarus, Lesli E.; Callaghan, Brian C.
2016-01-01
Objective: To describe neurologists' Medicare Part D prescribing patterns and the potential effect of generic substitutions and price negotiation, which is currently prohibited. Methods: The 2013 Medicare Part D Prescriber Public Use and Summary files were used. Payments for medications were aggregated by provider and drug (brand or generic). Payment, proportion of generic claims or day's supply, and median payment per monthly supply of medication were calculated by physician specialty and drug. Savings from generic substitution were estimated for brand drugs with a generic available. Medicare prices were compared to drug prices negotiated by the federal government with pharmaceutical manufacturers for the Veterans Administration (VA). Results: Neurologists comprised 13,060 (1.2%) providers with $5.0 billion (4.8%) in total payments, third highest of all specialties, with a median monthly payment of $141 (interquartile range $85–225). Multiple sclerosis drugs had the highest payments ($1.8 billion). Within neurologic disease groups ($3.4 billion in payments), 54.2%–91.8% of monthly supplies were generic, but 11.9%–71.3% of the payment was for generic medications. Generic substitution resulted in a $269 million (6.5%) payment decrease. VA pricing resulted in $1.5 billion (44.5% of $3.4 billion) in savings. Conclusions: High payment per monthly supply of medication underlies the high total neurology drug payments and is driven by multiple sclerosis drugs. Lowering drug expenditures by Medicare should focus on drug prices. PMID:27009256
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Generic and therapeutic substitutions in the UK: are they a good thing?
Duerden, Martin G; Hughes, Dyfrig A
2010-01-01
There is considerable interest and debate concerning the place of generic substitution (switching from a brand to generic product); and on therapeutic substitution, that is, switching to a cheaper, but apparently equivalent, product, usually within the drug class. Generic substitution by pharmacists is standard practice in UK hospital settings, and is being proposed for implementation in primary care. Although most prescriptions are already written generically (83% in the community in England in 2008), there are still cost savings that could be made if generic medicines are substituted against prescriptions written by branded name or by getting prescribers to adhere to advice to prescribe generically. Therapeutic substitution is more contentious, as direct evidence to support equivalence is normally lacking. However, the price differential between established drugs whose patents have expired and for which generics are available and newer, branded medicines within the same therapeutic class, makes therapeutic substitution an attractive application of cost-minimization analysis for the more efficient use of healthcare resources. Here we explore the tension that exists between the clinical appropriateness and safety of switching from an individual patient perspective and the consideration of value for money which is required to maximize population health from a health service perspective. Although substitution may affect individual patients (such as, for instance, reduced adherence, increased potential for medication error), it might be a price worth paying given the opportunity cost associated with the use of medicines that are clinically no better than cheaper alternatives. PMID:20716231
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Gasser, Urs E; Fischer, Anton; Timmermans, Jan P; Arnet, Isabelle
2013-04-23
By definition, a generic product is considered interchangeable with the innovator brand product. Controversy exists about interchangeability, and attention is predominantly directed to contaminants. In particular for chronic, degenerative conditions such as in Parkinson's disease (PD) generic substitution remains debated among physicians, patients and pharmacists. The objective of this study was to compare the pharmaceutical quality of seven generic levodopa/benserazide hydrochloride combination products marketed in Germany with the original product (Madopar® / Prolopa® 125, Roche, Switzerland) in order to evaluate the potential impact of Madopar® generics versus branded products for PD patients and clinicians. Madopar® / Prolopa® 125 tablets and capsules were used as reference material. The generic products tested (all 100 mg/25 mg formulations) included four tablet and three capsule formulations. Colour, appearance of powder (capsules), disintegration and dissolution, mass of tablets and fill mass of capsules, content, identity and amounts of impurities were assessed along with standard physical and chemical laboratory tests developed and routinely practiced at Roche facilities. Results were compared to the original "shelf-life" specifications in use by Roche. Each of the seven generic products had one or two parameters outside the specifications. Deviations for the active ingredients ranged from +8.4% (benserazide) to -7.6% (levodopa) in two tablet formulations. Degradation products were measured in marked excess (+26.5%) in one capsule formulation. Disintegration time and dissolution for levodopa and benserazide hydrochloride at 30 min were within specifications for all seven generic samples analysed, however with some outliers. Deviations for the active ingredients may go unnoticed by a new user of the generic product, but may entail clinical consequences when switching from original to generic during a long-term therapy. Degradation products may pose a safety concern. Our results should prompt caution when prescribing a generic of Madopar®/Prolopa®, and also invite to further investigations in view of a more comprehensive approach, both pharmaceutical and clinical.
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Triple effect absorption cycles
DOE Office of Scientific and Technical Information (OSTI.GOV)
Erickson, D.C.; Potnis, S.V.; Tang, J.
1996-12-31
Triple effect absorption chillers can achieve 50% COP improvement over double-effect systems. However, to translate this potential into cost-effective hardware, the most promising embodiments must be identified. In this study, 12 generic triple effect cycles and 76 possible hermetic loop arrangements of those 12 generic cycles were identified. The generic triple effect cycles were screened based on their pressure and solubility field requirements, generic COPs, risk involved in the component design, and number of components in a high corrosive environment. This screening identified four promising arrangements: Alkitrate Topping cycle, Pressure Staged Envelope cycle, High Pressure Overlap cycle, and Dual Loopmore » cycle. All of these arrangements have a very high COP ({approximately} 1.8), however the development risk and cost involved is different for each arrangement. Therefore, the selection of a particular arrangement will depend upon the specific situation under consideration.« less
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Mansfield, Sarah J
2014-02-01
To assess the degree to which reimbursement prices in Australia and England differ for a range of generic drugs, and to analyse the supply- and demand-side factors that may contribute to these differences. Australian and English reimbursement prices were compared for a range of generic drugs using pricing information obtained from government websites. Next, a literature review was conducted to identify supply- and demand-side factors that could affect generic prices in Australia and England. Various search topics were identified addressing potential supply-side (e.g. market approval, intellectual property protection of patented drugs, generic pricing policy, market size, generic supply chain and discounting practices) and demand-side (consumers, prescribers and pharmacists) factors. Related terms were searched in academic databases, official government websites, national statistical databases and internet search engines. Analysis of drug reimbursement prices for 15 generic molecules (representing 45 different drug presentations) demonstrated that Australian prices were on average over 7-fold higher than in England. Significant supply-side differences included aspects of pricing policy, the relative size of the generics markets and the use of clawback policies. Major differences in demand-side policies related to generic prescribing, pharmacist substitution and consumer incentives. Despite recent reforms, the Australian Government continues to pay higher prices than its English counterpart for many generic medications. The results suggest that particular policy areas may benefit from review in Australia, including the length of the price-setting process, the frequency of subsequent price adjustments, the extent of price competition between originators and generics, medical professionals' knowledge about generic medicines and incentives for generic prescribing. WHAT IS KNOWN ABOUT THE TOPIC? Prices of generic drugs have been the subject of much scrutiny over recent years. From 2005 to 2010 the Australian Government responded to observations that Pharmaceutical Benefits Scheme prices for many generics were higher than in numerous comparable countries by instituting several reforms aimed at reducing the prices of generics. Despite this, several studies have demonstrated that prices for generic statins (one class of cholesterol-lowering drug) are higher in Australia compared with England and many other developed countries, and prices of numerous other generics remain higher than in the USA and New Zealand. Recently there has been increasing interest in why these differences exist. WHAT DOES THIS PAPER ADD? By including a much larger range of commonly used and costly generic drugs, this paper builds significantly on the limited previous investigations of generic drug prices in Australia and England. Additionally, this is the first comprehensive investigation of multiple supply- and, in particular, demand-side factors that may explain any price differences between these countries. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners may contribute to the higher prices of generic medications in Australia compared with England through relatively low rates of generic prescribing. There are also significant implications for health policy makers, as this paper demonstrates that if Australia achieved the same prices as England for many generic drugs there could be substantial savings for the Pharmaceutical Benefits Scheme.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Rana, Malay Kumar; Chandra, Amalendu, E-mail: amalen@iitk.ac.in
2015-01-21
Atomistic simulations of model nonpolar nanotubes in a Stockmayer liquid are carried out for varying nanotube diameter and nanotube-solvent interactions to investigate solvophobic interactions in generic dipolar solvents. We have considered model armchair type single-walled nonpolar nanotubes with increasing radii from (5,5) to (12,12). The interactions between solute and solvent molecules are modeled by the well-known Lennard-Jones and repulsive Weeks-Chandler-Andersen potentials. We have investigated the density profiles and microscopic arrangement of Stockmayer molecules, orientational profiles of their dipole vectors, time dependence of their occupation, and also the translational and rotational motion of solvent molecules in confined environments of the cylindricalmore » nanopores and also in their external peripheral regions. The present results of structural and dynamical properties of Stockmayer molecules inside and near atomistically rough nonpolar surfaces including their wetting and dewetting behavior for varying interactions provide a more generic picture of solvophobic effects experienced by simple dipolar liquids without any specific interactions such as hydrogen bonds.« less
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NASA Astrophysics Data System (ADS)
Mehedi Faruk, Mir; Sazzad Hossain, Md.; Muktadir Rahman, Md.
2016-02-01
The changes in characteristics of Bose condensation of ideal Bose gas due to an external generic power law potential U=\\sumi=1dci\\vert xi/ai\\vertni are studied carefully. Detailed calculation of Kim et al. (J. Phys. Condens. Matter 11 (1999) 10269) yielded the hierarchy of condensation transitions with changing fractional dimensionality. In this manuscript, some theorems regarding specific heat at constant volume CV are presented. Careful examination of these theorems reveal the existence of hidden hierarchy of the condensation transition in trapped systems as well.
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TARGETED THERAPY: Generic imatinib — impact on frontline and salvage therapy for CML
Gorkin, Larry; Kantarjian, Hagop
2017-01-01
Imatinib has revolutionized the treatment of chronic myeloid leukaemia (CML). In 2016, generic imatinib will be introduced into the US market. We analyse the potential impact of this new product on patient care and optimal CML therapy, and comment on the effect that distorted cancer drug pricing in the USA will have on treatment for patients with limited therapeutic options. PMID:27098218
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Lätzer, Joachim; Shen, Tongye; Wolynes, Peter G
2008-02-19
We investigate how post-translational phosphorylation modifies the global conformation of a protein by changing its free energy landscape using two test proteins, cystatin and NtrC. We first examine the changes in a free energy landscape caused by phosphorylation using a model containing information about both structural forms. For cystatin the free energy cost is fairly large indicating a low probability of sampling the phosphorylated conformation in a perfectly funneled landscape. The predicted barrier for NtrC conformational transition is several times larger than the barrier for cystatin, indicating that the switch protein NtrC most probably follows a partial unfolding mechanism to move from one basin to the other. Principal component analysis and linear response theory show how the naturally occurring conformational changes in unmodified proteins are captured and stabilized by the change of interaction potential. We also develop a partially guided structure prediction Hamiltonian which is capable of predicting the global structure of a phosphorylated protein using only knowledge of the structure of the unphosphorylated protein or vice versa. This algorithm makes use of a generic transferable long-range residue contact potential along with details of structure short range in sequence. By comparing the results obtained with this guided transferable potential to those from the native-only, perfectly funneled Hamiltonians, we show that the transferable Hamiltonian correctly captures the nature of the global conformational changes induced by phosphorylation and can sample substantially correct structures for the modified protein with high probability.
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Self-locking degree-4 vertex origami structures
Li, Suyi; Wang, K. W.
2016-01-01
A generic degree-4 vertex (4-vertex) origami possesses one continuous degree-of-freedom for rigid folding, and this folding process can be stopped when two of its facets bind together. Such facet-binding will induce self-locking so that the overall structure stays at a pre-specified configuration without additional locking elements or actuators. Self-locking offers many promising properties, such as programmable deformation ranges and piecewise stiffness jumps, that could significantly advance many adaptive structural systems. However, despite its excellent potential, the origami self-locking features have not been well studied, understood, and used. To advance the state of the art, this research conducts a comprehensive investigation on the principles of achieving and harnessing self-locking in 4-vertex origami structures. Especially, for the first time, this study expands the 4-vertex structure construction from single-component to dual-component designs and investigates their self-locking behaviours. By exploiting various tessellation designs, this research discovers that the dual-component designs offer the origami structures with extraordinary attributes that the single-component structures do not have, which include the existence of flat-folded locking planes, programmable locking points and deformability. Finally, proof-of-concept experiments investigate how self-locking can effectively induce piecewise stiffness jumps. The results of this research provide new scientific knowledge and a systematic framework for the design, analysis and utilization of self-locking origami structures for many potential engineering applications. PMID:27956889
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Self-locking degree-4 vertex origami structures.
Fang, Hongbin; Li, Suyi; Wang, K W
2016-11-01
A generic degree-4 vertex (4-vertex) origami possesses one continuous degree-of-freedom for rigid folding, and this folding process can be stopped when two of its facets bind together. Such facet-binding will induce self-locking so that the overall structure stays at a pre-specified configuration without additional locking elements or actuators. Self-locking offers many promising properties, such as programmable deformation ranges and piecewise stiffness jumps, that could significantly advance many adaptive structural systems. However, despite its excellent potential, the origami self-locking features have not been well studied, understood, and used. To advance the state of the art, this research conducts a comprehensive investigation on the principles of achieving and harnessing self-locking in 4-vertex origami structures. Especially, for the first time, this study expands the 4-vertex structure construction from single-component to dual-component designs and investigates their self-locking behaviours. By exploiting various tessellation designs, this research discovers that the dual-component designs offer the origami structures with extraordinary attributes that the single-component structures do not have, which include the existence of flat-folded locking planes, programmable locking points and deformability. Finally, proof-of-concept experiments investigate how self-locking can effectively induce piecewise stiffness jumps. The results of this research provide new scientific knowledge and a systematic framework for the design, analysis and utilization of self-locking origami structures for many potential engineering applications.
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Thermodynamic theory of the plasmoelectric effect
van de Groep, Jorik; Sheldon, Matthew T.; Atwater, Harry A.; ...
2016-03-18
Resonant metal nanostructures exhibit an optically induced electrostatic potential when illuminated with monochromatic light under off-resonant conditions. This plasmoelectric effect is thermodynamically driven by the increase in entropy that occurs when the plasmonic structure aligns its resonant absorption spectrum with incident illumination by varying charge density. As a result, the elevated steady-state temperature of the nanostructure induced by plasmonic absorption is further increased by a small amount. Here, we study in detail the thermodynamic theory underlying the plasmoelectric effect by analyzing a simplified model system consisting of a single silver nanoparticle. We find that surface potentials as large as 473more » mV are induced under 100 W/m2 monochromatic illumination, as a result of a 11 mK increases in the steady-state temperature of the nanoparticle. Hence, we discuss the applicability of this analysis for realistic experimental geometries, and show that this effect is generic for optical structures in which the resonance is linked to the charge density.« less
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Farfan-Portet, Maria-Isabel; Van de Voorde, Carine; Vrijens, France; Vander Stichele, Robert
2012-06-01
The generic reference price system (RPS) can impose a financial penalty for patients using a brand name drug instead of its generic alternative. Previous studies on the impact of the RPS have not considered the potentially differential effect of using generic alternatives for individuals with a different socioeconomic background. However, patients' characteristics might determine their overall knowledge of the existence of the system and thus of the financial burden to which they may be confronted. The association between patients' characteristics and the use of generic drugs versus brand name drugs was analyzed for ten highly prescribed pharmaceutical molecules included in the Belgian generic reference price system. Prescriptions were obtained from a 10% sample of all general practitioners in 2008 (corresponding to 120,670 adult patients and 368,101 prescriptions). For each pharmaceutical molecule, logistic regression models were performed, with independent variables for patient socioeconomic background at the individual level (work status, having a guaranteed income and being entitled to increased reimbursement of co-payments) and at the level of the neighborhood (education). The percentage of generic prescriptions ranged from 24.7 to 76.4%, and the mean reference supplement in 2008 ranged from €4.3 to €37.8. For seven molecules, higher use of a generic alternative was associated with either having a guaranteed income, with receiving increased reimbursement of co-payments or with living in areas with the lowest levels of education. Globally, results provided evidence that the generic RPS in Belgium does not lead to a higher financial burden on individuals from a low socioeconomic background.
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Generic substitution of antihypertensive drugs: does it affect adherence?
Van Wijk, Boris L G; Klungel, Olaf H; Heerdink, Eibert R; de Boer, Anthonius
2006-01-01
Generic substitution is an important opportunity to reduce the costs of pharmaceutical care. However, pharmacists and physicians often find that patients and brand-name manufacturers have doubt about the equivalence of the substituted drug. This may be reflected by decreased adherence to therapy. To assess the association between generic substitution and nonadherence to antihypertensive drugs. We conducted a matched cohort study between January 1, 1999, and December 31, 2002. Data were obtained from PHARMO, a record linkage system containing drug-dispensing records from community pharmacies and linked hospital discharge records of approximately 950,000 people in The Netherlands. Residents of 30 medium-sized cities who initiated antihypertensive drug therapy were potential subjects. Refill adherence with antihypertensive drugs after substitution was determined; those with refill adherence below 80% were considered nonadherent. Four hundred sixty-three patients with a substitution in therapy and 565 controls, matched on age, gender, therapy start date, duration of use, and generic product code, were identified. Of the patients who switched from brand-name to generic formulations ("substituted"), 13.6% were nonadherent, and of the non-substituted patients (those who did not switch to generic), 18.7% were nonadherent (OR 0.68; 95% CI 0.48 to 0.96). The association was absent in males. None of the patients discontinued the medication. No differences in hospitalizations for cardiovascular disease in the 6 months after the substitution were observed. Generic substitution of antihypertensive drugs does not lead to lower adherence or more discontinuation and cardiovascular disease-related hospitalizations compared with brand-name therapy. When a less-expensive antihypertensive generic equivalent becomes available, generic substitution should be considered to achieve economic benefits.
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Engelkes, Marjolein; van Blijderveen, Jan C; Overbeek, Jetty A; Kuiper, Josephine; Herings, Ron C M; Sturkenboom, Miriam C J M; de Jongste, Johan C; Verhamme, Katia M C; Janssens, Hettie M
2017-11-29
The expiration of patents of brand inhalation medications and the ongoing pressure on healthcare budgets resulted in a growing market for generics. To study the use of brand and generic inhalation medication and the frequency of switching between brand and generic and between devices. In addition, we investigated whether switching affected adherence. From dispensing data from the Dutch PHARMO Database Network a cohort aged ≥ 5 years, using ≥ 1 year of inhalation medication between 2003 and 2012 was selected. Switching was defined as changing from brand to generic or vice versa. In addition, we studied change in aerosol delivery device type (e.g., DPI, pMDI, and nebulizers). Adherence was calculated using the medication possession ratio (MPR). The total cohort comprised 70,053 patients with 1,604,488 dispensations. Per calendar year, 5% switched between brand and generic inhalation medication and 5% switched between devices. Median MPRs over the first 12 months ranged between 33 and 55%. Median MPR over the total period was lower after switch from brand to generic and vice versa for formoterol (44.5 vs. 42.1 and 63.5 vs. 53.8) and beclomethasone (93.8 vs. 59.8 and 81.3 vs. 55.9). Per year, switching between brand and generic inhalation medication was limited to 5% of the patients, switching between device types was observed in 5% as well. Adherence to both generic and brand inhalation medication was low. Effect of switching on adherence was contradictory; depending on time period, medication and type, and direction of switching. Further research on reasons for switching and potential impact on clinical outcomes is warranted.
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The Clinical and Economic Impact of Generic Locking Plate Utilization at a Level II Trauma Center.
Mcphillamy, Austin; Gurnea, Taylor P; Moody, Alastair E; Kurnik, Christopher G; Lu, Minggen
2016-12-01
In today's climate of cost containment and fiscal responsibility, generic implant alternatives represent an interesting area of untapped resources. As patents have expired on many commonly used trauma implants, generic alternatives have recently become available from a variety of sources. The purpose of this study was to examine the clinical and economic impact of a cost containment program using high quality, generic orthopaedic locking plates. The implants available for study were anatomically precontoured plates for the clavicle, proximal humerus, distal radius, proximal tibia, distal tibia, and distal fibula. Retrospective review. Level II Trauma center. 828 adult patients with operatively managed clavicle, proximal humerus, distal radius, proximal tibia, tibial pilon, and ankle fractures. Operative treatment with conventional or generic implants. The 414 patients treated with generic implants were compared with 414 patients treated with conventional implants. There were no significant differences in age, sex, presence of diabetes, smoking history or fracture type between the generic and conventional groups. No difference in operative time, estimated blood loss or intraoperative complication rate was observed. No increase in postoperative infection rate, hardware failure, hardware loosening, malunion, nonunion or need for hardware removal was noted. Overall, our hospital realized a 56% reduction in implant costs, an average savings of $1197 per case, and a total savings of $458,080 for the study period. Use of generic orthopaedic implants has been successful at our institution, providing equivalent clinical outcomes while significantly reducing implant expenditures. Based on our data, the use of generic implants has the potential to markedly reduce operative costs as long as quality products are used. Therapeutic Level III.
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Projection Moire Interferometry Measurements of Micro Air Vehicle Wings
NASA Technical Reports Server (NTRS)
Fleming, Gary A.; Bartram, Scott M.; Waszak, Martin R.; Jenkins, Luther N.
2001-01-01
Projection Moire Interferometry (PMI) has been used to measure the structural deformation of micro air vehicle (MAV) wings during a series of wind tunnel tests. The MAV wings had a highly flexible wing structure, generically reminiscent of a bat s wing, which resulted in significant changes in wing shape as a function of MAV angle-of-attack and simulated flight speed. This flow-adaptable wing deformation is thought to provide enhanced vehicle stability and wind gust alleviation compared to rigid wing designs. Investigation of the potential aerodynamic benefits of a flexible MAV wing required measurement of the wing shape under aerodynamic loads. PMI was used to quantify the aerodynamically induced changes in wing shape for three MAV wings having different structural designs and stiffness characteristics. This paper describes the PMI technique, its application to MAV testing, and presents a portion of the PMI data acquired for the three different MAV wings tested.
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Subsumption principles underlying medical concept systems and their formal reconstruction.
Bernauer, J.
1994-01-01
Conventional medical concept systems represent generic concept relations by hierarchical coding principles. Often, these coding principles constrain the concept system and reduce the potential for automatical derivation of subsumption. Formal reconstruction of medical concept systems is an approach that bases on the conceptual representation of meanings and that allows for the application of formal criteria for subsumption. Those criteria must reflect intuitive principles of subordination which are underlying conventional medical concept systems. Particularly these are: The subordinate concept results (1) from adding a specializing criterion to the superordinate concept, (2) from refining the primary category, or a criterion of the superordinate concept, by a concept that is less general, (3) from adding a partitive criterion to a criterion of the superordinate, (4) from refining a criterion by a concept that is less comprehensive, and finally (5) from coordinating the superordinate concept, or one of its criteria. This paper introduces a formalism called BERNWARD that aims at the formal reconstruction of medical concept systems according to these intuitive principles. The automatical derivation of hierarchical relations is primarily supported by explicit generic and explicit partititive hierarchies of concepts, secondly, by two formal criteria that base on the structure of concept descriptions and explicit hierarchical relations between their elements, namely: formal subsumption and part-sensitive subsumption. Formal subsumption takes only generic relations into account, part-sensitive subsumption additionally regards partive relations between criteria. This approach seems to be flexible enough to cope with unforeseeable effects of partitive criteria on subsumption. PMID:7949907
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Generic Tasks for Knowledge-Based Problem Solving: Extension and New Directions
1991-02-01
Report. i 3] D. Brown and B. Chandrasekaran. Design: An information processing level analy- sis. In Design Problem Solving: Knowledge Structures and...generic information processing tasks. In Proceedings of the Internaoional Joint Conference on Artificial Inte!lzjence. IJCAI, 1987. [181 B...Chandrasekaran. What kind of information processing is intelligence? a perspective I on ai paradigms and a proposal. In D. Partridge and Y. Wilks, editors
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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
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Context-dependent effects of noise on echolocation pulse characteristics in free-tailed bats
Smotherman, Michael S.
2010-01-01
Background noise evokes a similar suite of adaptations in the acoustic structure of communication calls across a diverse range of vertebrates. Echolocating bats may have evolved specialized vocal strategies for echolocating in noise, but also seem to exhibit generic vertebrate responses such as the ubiquitous Lombard response. We wondered how bats balance generic and echolocation-specific vocal responses to noise. To address this question, we first characterized the vocal responses of flying free-tailed bats (Tadarida brasiliensis) to broadband noises varying in amplitude. Secondly, we measured the bats’ responses to band-limited noises that varied in the extent of overlap with their echolocation pulse bandwidth. We hypothesized that the bats’ generic responses to noise would be graded proportionally with noise amplitude, total bandwidth and frequency content, and consequently that more selective responses to band-limited noise such as the jamming avoidance response could be explained by a linear decomposition of the response to broadband noise. Instead, the results showed that both the nature and the magnitude of the vocal responses varied with the acoustic structure of the outgoing pulse as well as non-linearly with noise parameters. We conclude that free-tailed bats utilize separate generic and specialized vocal responses to noise in a context-dependent fashion. PMID:19672604
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Crystal growth, structure and morphology of hydrocortisone methanol solvate
NASA Astrophysics Data System (ADS)
Chen, Jianxin; Wang, Jiangkang; Zhang, Ying; Wu, Hong; Chen, Wei; Guo, Zhichao
2004-04-01
Hydrocortisone (HC), an important grucocorticoid, was crystallized from methanol solvent in the form of its methanol solvate. Its crystal structure belongs to orthorhombic, space group P2 12 12 1, with the unit cell parameters a=7.712(3) Å, b=14.392(5) Å, c=18.408(6) Å, Z=4. The methanol takes part in intermolecular hydrogen bonding, so if we change the solvent, the crystal habit of HC maybe different. The long parallelepiped morphology was also predicted by Cerius 2TM simulation program. The influence of intermolecular interaction was taken into account in the attachment energy model. The morphology calculation performed on the potential energy minimized model using a generic DREIDING 2.21 force field and developed minimization protocol with derived partial charges fits the experimental crystal shape well.
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A Generic Structural Integrity Assurance Technology Program for the Army
1989-11-01
and Pressure Vessel Code , American Society of Mechanical Engineers, 1986. DEFINITIONS AND ACRONYMS Definitions A-Basis: At least 99 percent of the...Aluminum Bridge and Other Highway Structures, 1976. Aluminum Association Specifications for Aluminum Structures, Third Edition, 1976. ASME ASME Boiler
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76 FR 69292 - Aging Management of Stainless Steel Structures and Components in Treated Borated Water
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-08
... NUCLEAR REGULATORY COMMISSION [NRC-2011-0256] Aging Management of Stainless Steel Structures and... Stainless Steel Structures and Components in Treated Borated Water.'' This LR-ISG revises the guidance in...) and Generic Aging Lessons Learned (GALL) Report for the aging management of stainless steel structures...
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Survey of inorganic polymers. [for composite matrix resins
NASA Technical Reports Server (NTRS)
Gerber, A. H.; Mcinerney, E. F.
1979-01-01
A literature search was carried out in order to identify inorganic, metallo-organic, and hybrid inorganic-organic polymers that could serve as potential matrix resins for advanced composites. The five most promising candidates were critically reviewed and recommendations were made for the achievement of their potential in terms of performance and cost. These generic polymer classes comprise: (1) Poly(arylsil sesquioxanes); (2) Poly(silyl arylene siloxanes); (3) Poly(silarylenes); (4) Poly(silicon-linked ferrocenes); and (5) Poly(organo phosphazenes). No single candidate currently possesses the necessary combination of physicomechanical properties, thermal stability, processability, and favorable economics. The first three classes exhibit the best thermal performance. On the other hand, poly (organo phosphazenes), the most extensively studied polymer class, exhibit the best combination of structure-property control, processability, and favorable economics.
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NASA Thesaurus. Volume 1: Hierarchical listing. Volume 2: Access vocabulary. Volume 3: Definitions
NASA Technical Reports Server (NTRS)
1994-01-01
There are over 17,500 postable terms and some 4,000 nonpostable terms approved for use in the NASA Scientific and Technical Information Database in the Hierarchical Listing of the NASA Thesaurus. The generic structure is presented for many terms. The broader term and narrower term relationships are shown in an indented fashion that illustrates the generic structure better than the more widely used BT and NT listings. Related terms are generously applied, thus enhancing the usefulness of the Hierarchical Listing. Greater access to the Hierarchical Listing may be achieved with the collateral use of Volume 2 - Access Vocabulary and Volume 3 - Definitions.
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Estimating structural collapse fragility of generic building typologies using expert judgment
Jaiswal, Kishor; Wald, David J.; Perkins, David M.; Aspinall, Willy P.; Kiremidjian, Anne S.
2014-01-01
The structured expert elicitation process proposed by Cooke (1991), hereafter referred to as Cooke's approach, is applied for the first time in the realm of structural collapse-fragility assessment for selected generic construction types. Cooke's approach works on the principle of objective calibration scoring of judgments couple with hypothesis testing used in classical statistics. The performance-based scoring system reflects the combined measure of an expert's informativeness about variables in the problem are under consideration, and their ability to enumerate, in a statistically accurate way through expressing their true beliefs, the quantitative uncertainties associated with their assessments. We summarize the findings of an expert elicitation workshop in which a dozen earthquake-engineering professionals from around the world were engaged to estimate seismic collapse fragility for generic construction types. Development of seismic collapse fragility-functions was accomplished by combining their judgments using weights derived from Cooke's method. Although substantial effort was needed to elicit the inputs of these experts successfully, we anticipate that the elicitation strategy described here will gain momentum in a wide variety of earthquake seismology and engineering hazard and risk analyses where physical model and data limitations are inherent and objective professional judgment can fill gaps.
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Estimating structural collapse fragility of generic building typologies using expert judgment
Jaiswal, Kishor S.; Wald, D.J.; Perkins, D.; Aspinall, W.P.; Kiremidjian, Anne S.; Deodatis, George; Ellingwood, Bruce R.; Frangopol, Dan M.
2014-01-01
The structured expert elicitation process proposed by Cooke (1991), hereafter referred to as Cooke’s approach, is applied for the first time in the realm of structural collapse-fragility assessment for selected generic construction types. Cooke’s approach works on the principle of objective calibration scoring of judgments coupled with hypothesis testing used in classical statistics. The performance-based scoring system reflects the combined measure of an expert’s informativeness about variables in the problem area under consideration, and their ability to enumerate, in a statistically accurate way through expressing their true beliefs, the quantitative uncertainties associated with their assessments. We summarize the findings of an expert elicitation workshop in which a dozen earthquake-engineering professionals from around the world were engaged to estimate seismic collapse fragility for generic construction types. Development of seismic collapse fragility functions was accomplished by combining their judgments using weights derived from Cooke’s method. Although substantial effort was needed to elicit the inputs of these experts successfully, we anticipate that the elicitation strategy described here will gain momentum in a wide variety of earthquake seismology and engineering hazard and risk analyses where physical model and data limitations are inherent and objective professional judgment can fill gaps.
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Pose estimation of teeth through crown-shape matching
NASA Astrophysics Data System (ADS)
Mok, Vevin; Ong, Sim Heng; Foong, Kelvin W. C.; Kondo, Toshiaki
2002-05-01
This paper presents a technique for determining a tooth's pose given a dental plaster cast and a set of generic tooth models. The ultimate goal of pose estimation is to obtain information about the sizes and positions of the roots, which lie hidden within the gums, without the use of X-rays, CT or MRI. In our approach, the tooth of interest is first extracted from the 3D dental cast image through segmentation. 2D views are then generated from the extracted tooth and are matched against a target view generated from the generic model with known pose. Additional views are generated in the vicinity of the best view and the entire process is repeated until convergence. Upon convergence, the generic tooth is superimposed onto the dental cast to show the position of the root. The results of applying the technique to canines demonstrate the excellent potential of the algorithm for generic tooth fitting.
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Nonequilibrium thermodynamics of the shear-transformation-zone model
NASA Astrophysics Data System (ADS)
Luo, Alan M.; Ã-ttinger, Hans Christian
2014-02-01
The shear-transformation-zone (STZ) model has been applied numerous times to describe the plastic deformation of different types of amorphous systems. We formulate this model within the general equation for nonequilibrium reversible-irreversible coupling (GENERIC) framework, thereby clarifying the thermodynamic structure of the constitutive equations and guaranteeing thermodynamic consistency. We propose natural, physically motivated forms for the building blocks of the GENERIC, which combine to produce a closed set of time evolution equations for the state variables, valid for any choice of free energy. We demonstrate an application of the new GENERIC-based model by choosing a simple form of the free energy. In addition, we present some numerical results and contrast those with the original STZ equations.
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Di Mascolo, Maria; Gouin, Alexia
2013-03-01
The work presented here is with a view to improving performance of sterilization services in hospitals. We carried out a survey in a large number of health establishments in the Rhône-Alpes region in France. Based on the results of this survey and a detailed study of a specific service, we have built a generic model. The generic nature of the model relies on a common structure with a high level of detail. This model can be used to improve the performance of a specific sterilization service and/or to dimension its resources. It can also serve for quantitative comparison of performance indicators of various sterilization services.
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Chen, Limei; Li, Haijuan; He, Haili; Wu, Haoxi; Jin, Yongdong
2015-07-07
Fast and accurate identification of cancer cells from healthy normal cells in a simple, generic way is very crucial for early cancer detection and treatment. Although functional nanoparticles, like fluorescent quantum dots and plasmonic Au nanoparticles (NPs), have been successfully applied for cancer cell imaging and photothermal therapy, they suffer from the main drawback of needing time-consuming targeting preparation for specific cancer cell detection and selective ablation. The lack of a generic and effective method therefore limits their potential high-throughput cancer cell preliminary screening and theranostic applications. We report herein a generic in vitro method for fast, targeting-free (avoiding time-consuming preparations of targeting moiety for specific cancer cells) visual screening and selective killing of cancer cells from normal cells, by using glucose-responsive/-sensitive glucose oxidase-modified Ag/Au nanoshells (Ag/Au-GOx NSs) as a smart plasmonic theranostic agent. The method is generic to some extent since it is based on the distinct localized surface plasmon resonance (LSPR) responses (and colors) of the smart nanoprobe with cancer cells (typically have a higher glucose uptake level) and normal cells.
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Cimpian, Andrei; Cadena, Cristina
2010-10-01
Artifacts pose a potential learning problem for children because the mapping between their features and their functions is often not transparent. In solving this problem, children are likely to rely on a number of information sources (e.g., others' actions, affordances). We argue that children's sensitivity to nuances in the language used to describe artifacts is an important, but so far unacknowledged, piece of this puzzle. Specifically, we hypothesize that children are sensitive to whether an unfamiliar artifact's features are highlighted using generic (e.g., "Dunkels are sticky") or non-generic (e.g., "This dunkel is sticky") language. Across two studies, older-but not younger-preschoolers who heard such features introduced via generic statements inferred that they are a functional part of the artifact's design more often than children who heard the same features introduced via non-generic statements. The ability to pick up on this linguistic cue may expand considerably the amount of conceptual information about artifacts that children derive from conversations with adults. Copyright 2010 Elsevier B.V. All rights reserved.
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Fractal geometry as a new approach for proving nanosimilarity: a reflection note.
Demetzos, Costas; Pippa, Natassa
2015-04-10
Nanosimilars are considered as new medicinal outcomes combining the generic drugs and the nanocarrier as an innovative excipient, in order to evaluate them as final products. They belong to the grey area - concerning the evaluation process - between generic drugs and biosimilar medicinal products. Generic drugs are well documented and a huge number of them are in market, replacing effectively the off-patent drugs. The scientific approach for releasing them to the market is based on bioequivalence studies, which are well documented and accepted by the regulatory agencies. On the other hand, the structural complexity of biological/biotechnology-derived products demands a new approach for the approval process taking into consideration that bioequivalence studies are not considered as sufficient as in generic drugs, and new clinical trials are needed to support their approval process of the product to the market. In proportion, due to technological complexity of nanomedicines, the approaches for proving the statistical identity or the similarity for generic and biosimilar products, respectively, with those of prototypes, are not considered as effective for nanosimilar products. The aim of this note is to propose a complementary approach which can provide realistic evidences concerning the nanosimilarity, based on fractal analysis. This approach is well fit with the structural complexity of nanomedicines and smooths the difficulties for proving the similarity between off-patent and nanosimilar products. Fractal analysis could be considered as the approach that completely characterizes the physicochemical/morphological characteristics of nanosimilar products and could be proposed as a start point for a deep discussion on nanosimilarity. Copyright © 2015 Elsevier B.V. All rights reserved.
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Modeling HIV/AIDS Drug Price Determinants in Brazil: Is Generic Competition a Myth?
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
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Definition and Classification of Generic Drugs Across the World.
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.
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Halme, Merja; Linden, Kari; Kääriä, Kimmo
2009-12-01
: Despite increased use of generic medicines, little is known about either the attitudes of patients towards them or the decision-making process surrounding them. Young adults use over-the-counter (OTC) analgesics relatively often. : To assess the preferences of patients for generic and branded OTC pain medicines, to identify clusters with different preference structures, and to estimate the price elasticity of a generic alternative among university students. : Finnish university students (n = 256; students in courses at the Helsinki School of Economics) responded to an adaptive conjoint analysis (ACA) questionnaire on the choice between branded and generic OTC ibuprofen products. Product attributes of price, brand, onset time of effect, place of purchase and source of information were included in the questionnaire on the basis of the literature, a focus group and a previous pilot study. Several socioeconomic and health behavior descriptors were employed. Individual-level utility functions were estimated, preference clusters were identified, and the price elasticity of the generic medicine was assessed. : Five clusters with characteristic individual-level preferences and price elasticity but few differences in socioeconomic background were detected. Approximately half of the respondents were strongly price sensitive while the others had other preferences such as brand or an opportunity to buy the medicine at a pharmacy or to have a physician or a pharmacist as an information source. : The study provided new information on the concomitant effects of brand, price and other essential product attributes on the choice by patients between branded and generic medicines.
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Modeling HIV/AIDS drug price determinants in Brazil: is generic competition a myth?
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.
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Neto, Alberto Moreira Da Silva; Aldrete, Alfonso N García; Rafael, José Albertino
2016-03-03
Brasineura serranortensis sp. n. is here described and illustrated. This is the third known species of Brasineura and differs from the other species in the genus in phallosome, hypandrium and paraproct structure. Comments on variation in fore wing venation, and new records for B. troglophilica are included. A revised generic diagnosis is also presented.
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Finch, Aureliano Paolo; Brazier, John Edward; Mukuria, Clara; Bjorner, Jakob Bue
2017-12-01
Generic preference-based measures such as the EuroQol five-dimensional questionnaire (EQ-5D) are used in economic evaluation, but may not be appropriate for all conditions. When this happens, a possible solution is adding bolt-ons to expand their descriptive systems. Using review-based methods, studies published to date claimed the relevance of bolt-ons in the presence of poor psychometric results. This approach does not identify the specific dimensions missing from the Generic preference-based measure core descriptive system, and is inappropriate for identifying dimensions that might improve the measure generically. This study explores the use of principal-component analysis (PCA) and confirmatory factor analysis (CFA) for bolt-on identification in the EQ-5D. Data were drawn from the international Multi-Instrument Comparison study, which is an online survey on health and well-being measures in five countries. Analysis was based on a pool of 92 items from nine instruments. Initial content analysis provided a theoretical framework for PCA results interpretation and CFA model development. PCA was used to investigate the underlining dimensional structure and whether EQ-5D items were represented in the identified constructs. CFA was used to confirm the structure. CFA was cross-validated in random halves of the sample. PCA suggested a nine-component solution, which was confirmed by CFA. This included psychological symptoms, physical functioning, and pain, which were covered by the EQ-5D, and satisfaction, speech/cognition,relationships, hearing, vision, and energy/sleep which were not. These latter factors may represent relevant candidate bolt-ons. PCA and CFA appear useful methods for identifying potential bolt-ons dimensions for an instrument such as the EQ-5D. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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Spine labeling in MRI via regularized distribution matching.
Hojjat, Seyed-Parsa; Ayed, Ismail; Garvin, Gregory J; Punithakumar, Kumaradevan
2017-11-01
This study investigates an efficient (nearly real-time) two-stage spine labeling algorithm that removes the need for an external training while being applicable to different types of MRI data and acquisition protocols. Based solely on the image being labeled (i.e., we do not use training data), the first stage aims at detecting potential vertebra candidates following the optimization of a functional containing two terms: (i) a distribution-matching term that encodes contextual information about the vertebrae via a density model learned from a very simple user input, which amounts to a point (mouse click) on a predefined vertebra; and (ii) a regularization constraint, which penalizes isolated candidates in the solution. The second stage removes false positives and identifies all vertebrae and discs by optimizing a geometric constraint, which embeds generic anatomical information on the interconnections between neighboring structures. Based on generic knowledge, our geometric constraint does not require external training. We performed quantitative evaluations of the algorithm over a data set of 90 mid-sagittal MRI images of the lumbar spine acquired from 45 different subjects. To assess the flexibility of the algorithm, we used both T1- and T2-weighted images for each subject. A total of 990 structures were automatically detected/labeled and compared to ground-truth annotations by an expert. On the T2-weighted data, we obtained an accuracy of 91.6% for the vertebrae and 89.2% for the discs. On the T1-weighted data, we obtained an accuracy of 90.7% for the vertebrae and 88.1% for the discs. Our algorithm removes the need for external training while being applicable to different types of MRI data and acquisition protocols. Based on the current testing data, a subject-specific model density and generic anatomical information, our method can achieve competitive performances when applied to T1- and T2-weighted MRI images.
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Gama, Helena; Torre, Carla; Guerreiro, José Pedro; Azevedo, Ana; Costa, Suzete; Lunet, Nuno
2017-06-29
The successful control of cardiovascular diseases at the lowest possible cost requires the use of the most effective and affordable medicines. We aimed to describe the trends in the ambulatory use of medicines for prevention and treatment of cardiovascular diseases [Anatomic Therapeutic Chemical classification system (ATC): C and B01A] in Portugal, between 2004 and 2012, and to estimate the potential for expenditure reduction through changes in patterns of use. We analysed sell-out data, expressed as defined daily doses (DDD) and pharmacy retail price (€), from a nationwide database. We estimated potential reduction in expenditures through the increase, up to 90% of the volume of DDD, in the use of generic and essential medicines; the latter were defined according to guidelines from Portugal and another European country. Overall consumption increased by approximately 50% from 2004 to 2012, reaching nearly 2400 million DDD, whereas expenditure decreased to 753 million € (-31.3% since 2006). Use of generics and essential medicines increased, representing 43.6 and 39.9% of DDD consumption in 2012, respectively. The 40 most used groups of medicines in 2012 accounted for just over 80% of overall consumption; among these, increase in use of generics and essential medicines would have contributed to a saving of 275 million €. Changes in patterns of consumption of medicines towards a more frequent use of generics, a preferential use of essential medicines and a more rational use of fixed-dose combinations may contribute to a more efficient use of health resources.
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Summers, Alexander; Ruderman, Carly; Leung, Fok-Han; Slater, Morgan
2017-09-22
Studies in the United States have shown that physicians commonly use brand names when documenting medications in an outpatient setting. However, the prevalence of prescribing and documenting brand name medication has not been assessed in a clinical teaching environment. The purpose of this study was to describe the use of generic versus brand names for a select number of pharmaceutical products in clinical documentation in a large, urban academic family practice centre. A retrospective chart review of the electronic medical records of the St. Michael's Hospital Academic Family Health Team (SMHAFHT). Data for twenty commonly prescribed medications were collected from the Cumulative Patient Profile as of August 1, 2014. Each medication name was classified as generic or trade. Associations between documentation patterns and physician characteristics were assessed. Among 9763 patients prescribed any of the twenty medications of interest, 45% of patient charts contained trade nomenclature exclusively. 32% of charts contained only generic nomenclature, and 23% contained a mix of generic and trade nomenclature. There was large variation in use of generic nomenclature amongst physicians, ranging from 19% to 93%. Trade names in clinical documentation, which likely reflect prescribing habits, continue to be used abundantly in the academic setting. This may become part of the informal curriculum, potentially facilitating undue bias in trainees. Further study is needed to determine characteristics which influence use of generic or trade nomenclature and the impact of this trend on trainees' clinical knowledge and decision-making.
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2013-01-01
Background By definition, a generic product is considered interchangeable with the innovator brand product. Controversy exists about interchangeability, and attention is predominantly directed to contaminants. In particular for chronic, degenerative conditions such as in Parkinson’s disease (PD) generic substitution remains debated among physicians, patients and pharmacists. The objective of this study was to compare the pharmaceutical quality of seven generic levodopa/benserazide hydrochloride combination products marketed in Germany with the original product (Madopar® / Prolopa® 125, Roche, Switzerland) in order to evaluate the potential impact of Madopar® generics versus branded products for PD patients and clinicians. Methods Madopar® / Prolopa® 125 tablets and capsules were used as reference material. The generic products tested (all 100 mg/25 mg formulations) included four tablet and three capsule formulations. Colour, appearance of powder (capsules), disintegration and dissolution, mass of tablets and fill mass of capsules, content, identity and amounts of impurities were assessed along with standard physical and chemical laboratory tests developed and routinely practiced at Roche facilities. Results were compared to the original “shelf-life” specifications in use by Roche. Results Each of the seven generic products had one or two parameters outside the specifications. Deviations for the active ingredients ranged from +8.4% (benserazide) to −7.6% (levodopa) in two tablet formulations. Degradation products were measured in marked excess (+26.5%) in one capsule formulation. Disintegration time and dissolution for levodopa and benserazide hydrochloride at 30 min were within specifications for all seven generic samples analysed, however with some outliers. Conclusions Deviations for the active ingredients may go unnoticed by a new user of the generic product, but may entail clinical consequences when switching from original to generic during a long-term therapy. Degradation products may pose a safety concern. Our results should prompt caution when prescribing a generic of Madopar®/Prolopa®, and also invite to further investigations in view of a more comprehensive approach, both pharmaceutical and clinical. PMID:23617953
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Alkhuzaee, Fahad S; Almalki, Hamdan M; Attar, Ammar Y; Althubiani, Shoeab I; Almuallim, Wassam Ali; Cheema, Ejaz; Hadi, Muhammad Abdul
2016-12-01
To assess the community pharmacists' knowledge, attitude, perception and current practices towards generic medicines substitution in Saudi Arabia. A cross-sectional study was conducted between February and March 2016 in the Makkah region, Saudi Arabia. A 25-item, structured, validated, pilot-tested and self-completed questionnaire was used to achieve study objectives. A 4-step systematic sampling technique was used to recruit community pharmacists. Data were analysed using SPSS version 20. Of 128 community pharmacists approached, 121 participated in the study (response rate=95%). Majority of the participants (n=108; 89.3%) had graduated from Egypt, were working as staff pharmacists (n=85; 70%) and had BPharm degree (97; 80.2%). Only 26 (22%) of the participants correctly answered all knowledge questions accurately. No statistically significant difference in total knowledge score was observed across different sociodemographic characteristics of participants (all P>0.05).Two-thirds of the respondents (83; 68.2%) supported the use of generic substitution. Medicines cost and patients' request were the most commonly cited reasons for performing generic substitution. Country of graduation (P=0.01) and number of years of practicing in Saudi Arabia (P=0.02) was associated with the pharmacists' support towards generic substitution. The community pharmacists had clear knowledge deficits about generic medicines and their substitution which may partly explain low consumption of generic medicines in Saudi Arabia. Healthcare policy makers need to improve awareness about the safety and efficacy of generic medicines and promote their use in order to cut down cost of medicines and overall healthcare expenditure. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
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Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer
2017-04-01
In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands on quality and transparency, triggered by, amongst others, current legislation (Hospital Structures Act, anti-corruption legislation). Copyright © 2017. Published by Elsevier GmbH.
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A methodology for the environmental assessment of advanced coal extraction systems
NASA Technical Reports Server (NTRS)
Sullivan, P. J.; Hutchinson, C. F.; Makihara, J.; Evensizer, J.
1980-01-01
Procedures developed to identify and assess potential environment impacts of advanced mining technology as it moves from a generic concept to a more systems definition are described. Two levels of assessment are defined in terms of the design stage of the technology being evaluated. The first level of analysis is appropriate to a conceptual design. At this level it is assumed that each mining process has known and potential environmental impacts that are generic to each mining activity. By using this assumption, potential environmental impacts can be identified for new mining systems. When two or more systems have been assessed, they can be evaluated comparing potential environmental impacts. At the preliminary stage of design, a systems performance can be assessed again with more precision. At this level of systems definition, potential environmental impacts can be analyzed and their significane determined in a manner to facilitate comparisons between systems. At each level of analysis, suggestions calculated to help the designer mitigate potentially harmful impacts are provided.
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Firm- and drug-specific patterns of generic drug payments by US medicaid programs: 1991-2008.
Kelton, Christina M L; Chang, Lenisa V; Guo, Jeff J; Yu, Yan; Berry, Edmund A; Bian, Boyang; Heaton, Pamela C
2014-04-01
The entry of generic drugs into markets previously monopolized by patented, branded drugs often represents large potential savings for healthcare payers in the USA. Our objectives were to describe and explain the trends in drug reimbursement by public Medicaid programmes post-generic entry for as many drug markets and for as long a time period as possible. The data were the Medicaid State Drug Utilization Data maintained by the Centers for Medicare and Medicaid Services. Quarterly utilization and expenditure data from 1991 to 2008 were extracted for 83 drugs, produced by 229 firms, that experienced initial generic entry between 1992 and 2004. A relative 'price' for a specific drug, firm and quarter was constructed as Medicaid reimbursement per unit (e.g. tablet, capsule or vial) divided by average reimbursement per unit for the branded drug the year before entry. Fixed-effects models controlling for time-, firm- and drug-specific differences were estimated to explain reimbursement. Twelve quarters after generic entry, 18 % of drugs had average per-unit reimbursement less than 50 % of the original branded-drug reimbursement. For each additional firm manufacturing the drug, reimbursement per unit, relative to the pre-generic-entry branded-drug reimbursement, was estimated to fall by 17 (p < 0.01) and 3 (p < 0.01) percentage points for generic and branded-drug companies, respectively. Each additional quarter post-generic entry brought a 2 (p < 0.01) percentage point drop in relative reimbursement. State Medicaid programmes generally have been able to obtain relief from high drug prices following patent expirations for many branded-drug medications by adjusting reimbursement following the expanded competition in the pharmaceutical market.
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Moon, James C; Godman, Brian; Petzold, Max; Alvarez-Madrazo, Samantha; Bennett, Kathleen; Bishop, Iain; Bucsics, Anna; Hesse, Ulrik; Martin, Andrew; Simoens, Steven; Zara, Corinne; Malmström, Rickard E
2014-01-01
There is an urgent need for health authorities across Europe to fully realize potential savings from increased use of generics to sustain their healthcare systems. A variety of strategies were used across Europe following the availability of generic losartan, the first angiotensin receptor blocker (ARB) to be approved and marketed, to enhance its prescribing vs. single-sourced drugs in the class. Demand-side strategies ranged from 100% co-payment for single-sourced ARBs in Denmark to no specific measures. We hypothesized this heterogeneity of approaches would provide opportunities to explore prescribing in a class following patent expiry. Contrast the impact of the different approaches among European countries and regions to the availability of generic losartan to provide future guidance. Retrospective segmented regression analyses applying linear random coefficient models with country specific intercepts and slopes were used to assess the impact of the various initiatives across Europe following the availability of generic losartan. Utilization measured in defined daily doses (DDDs). Price reductions for generic losartan were also measured. Utilization of losartan was over 90% of all ARBs in Denmark by the study end. Multiple measures in Sweden and one English primary care group also appreciably enhanced losartan utilization. Losartan utilization actually fell in some countries with no specific demand-side measures. Considerable differences were seen in the prices of generic losartan. Delisting single-sourced ARBs produced the greatest increase in losartan utilization. Overall, multiple demand-side measures are needed to change physician prescribing habits to fully realize savings from generics. There is no apparent "spill over" effect from one class to another to influence future prescribing patterns even if these are closely related.
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The impact of generic language about ability on children's achievement motivation.
Cimpian, Andrei
2010-09-01
Nuances in how adults talk about ability may have important consequences for children's sustained involvement and success in an activity. In this study, I tested the hypothesis that children would be less motivated while performing a novel activity if they were told that boys or girls in general are good at this activity (generic language) than if they were told that a particular boy or girl is good at it (non-generic language). Generic language may be detrimental because it expresses normative societal expectations regarding performance. If these expectations are negative, they may cause children to worry about confirming them; if positive, they may cause worries about failing to meet them. Moreover, generic statements may be threatening because they imply that performance is the result of stable traits rather than effort. Ninety-seven 4- to 7-year-olds were asked to play a game in which they succeeded at first but then made a few mistakes. Since young children remain optimistic in achievement situations until the possibility of failure is made clear, I hypothesized that 4- and 5-year-olds would not be affected by the implications of generic language until after they made mistakes; 6- and 7-year-olds, however, may be susceptible earlier. As expected, the older children who heard that boys or girls are good at this game displayed lower motivation (e.g., more negative emotions, lower perceived competence) from the start, while they were still succeeding and receiving praise. Four- and 5-year-olds who heard these generic statements had a similar reaction, but only after they made mistakes. These findings demonstrate that exposure to generic language about ability can be an obstacle to children's motivation and, potentially, their success.
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Moon, James C.; Godman, Brian; Petzold, Max; Alvarez-Madrazo, Samantha; Bennett, Kathleen; Bishop, Iain; Bucsics, Anna; Hesse, Ulrik; Martin, Andrew; Simoens, Steven; Zara, Corinne; Malmström, Rickard E.
2014-01-01
Introduction: There is an urgent need for health authorities across Europe to fully realize potential savings from increased use of generics to sustain their healthcare systems. A variety of strategies were used across Europe following the availability of generic losartan, the first angiotensin receptor blocker (ARB) to be approved and marketed, to enhance its prescribing vs. single-sourced drugs in the class. Demand-side strategies ranged from 100% co-payment for single-sourced ARBs in Denmark to no specific measures. We hypothesized this heterogeneity of approaches would provide opportunities to explore prescribing in a class following patent expiry. Objective: Contrast the impact of the different approaches among European countries and regions to the availability of generic losartan to provide future guidance. Methodology: Retrospective segmented regression analyses applying linear random coefficient models with country specific intercepts and slopes were used to assess the impact of the various initiatives across Europe following the availability of generic losartan. Utilization measured in defined daily doses (DDDs). Price reductions for generic losartan were also measured. Results: Utilization of losartan was over 90% of all ARBs in Denmark by the study end. Multiple measures in Sweden and one English primary care group also appreciably enhanced losartan utilization. Losartan utilization actually fell in some countries with no specific demand-side measures. Considerable differences were seen in the prices of generic losartan. Conclusion: Delisting single-sourced ARBs produced the greatest increase in losartan utilization. Overall, multiple demand-side measures are needed to change physician prescribing habits to fully realize savings from generics. There is no apparent “spill over” effect from one class to another to influence future prescribing patterns even if these are closely related. PMID:25339902
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Generic immunosuppression in solid organ transplantation: a Canadian perspective.
Harrison, Jennifer J; Schiff, Jeffrey R; Coursol, Christian J; Daley, Christopher J A; Dipchand, Anne I; Heywood, Norine M; Keough-Ryan, Tammy M; Keown, Paul A; Levy, Gary A; Lien, Dale C; Wichart, Jenny R; Cantarovich, Marcelo
2012-04-15
The introduction of generic immunosuppressant medications may present an opportunity for cost savings in solid organ transplantation if equivalent clinical outcomes to the branded counterparts can be achieved. An interprofessional working group of the Canadian Society of Transplantation was established to develop recommendations on the use of generic immunosuppression in solid organ transplant recipients (SOTR) based on a review of the available data. Under current Health Canada licensing requirements, a demonstration of bioequivalence with the branded formulation in healthy volunteers allows for bridging of clinical data. Cyclosporine, tacrolimus, and sirolimus are designated as "critical dose drugs" and are held to stricter criteria. However, whether this provides sufficient guarantee of therapeutic equivalence in SOTR remains controversial, and failure to maintain an appropriate balance of immunosuppression may have serious consequences, including rejection, graft loss, and death. Published evidence supporting therapeutic equivalence of generic formulations in SOTR is lacking. Moreover, in the setting of multiple generic formulations the potential for uncontrolled product switching is a major concern, since generic preparations are not required to demonstrate bioequivalence with each other. Although close monitoring is recommended with any change in formulation, drug product switches are likely to occur without prescriber knowledge and may pose a significant patient safety risk. The advent of generic immunosuppression will require new practices including more frequent therapeutic drug and clinical monitoring, and increased patient education. The additional workload placed on transplant centers without additional funding will create challenges and could ultimately jeopardize patient outcomes. Until more robust clinical data are available and adequate regulatory safeguards are instituted, caution in the use of generic immunosuppressive drugs in solid organ transplantation is warranted.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Mohamed Abdelrahman; roger Haggard; Wagdy Mahmoud
The final goal of this project was the development of a system that is capable of controlling an industrial process effectively through the integration of information obtained through intelligent sensor fusion and intelligent control technologies. The industry of interest in this project was the metal casting industry as represented by cupola iron-melting furnaces. However, the developed technology is of generic type and hence applicable to several other industries. The system was divided into the following four major interacting components: 1. An object oriented generic architecture to integrate the developed software and hardware components @. Generic algorithms for intelligent signal analysismore » and sensor and model fusion 3. Development of supervisory structure for integration of intelligent sensor fusion data into the controller 4. Hardware implementation of intelligent signal analysis and fusion algorithms« less
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Structures performance, benefit, cost-study
NASA Technical Reports Server (NTRS)
Woike, O. G.; Salemme, C.; Stearns, E.; Oritz, P.; Roberts, M. L.; Baughman, J. L.; Johnston, R. P.; Demel, H. F.; Stabrylla, R. G.; Coffinberry, G. A.
1981-01-01
New technology concepts and structural analysis development needs which could lead to improved life cycle cost for future high-bypass turbofans were studied. The NASA-GE energy efficient engine technology is used as a base to assess the concept benefits. Recommended programs are identified for attaining these generic structural and other beneficial technologies.
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Intrinsically Disordered Protein Specific Force Field CHARMM36IDPSFF.
Liu, Hao; Song, Dong; Lu, Hui; Luo, Ray; Chen, Hai-Feng
2018-05-28
Intrinsically disordered proteins (IDPs) are closely related to various human diseases. Because IDPs lack certain tertiary structure, it is difficult to use X-ray and NMR methods to measure their structures. Therefore, molecular dynamics simulation is a useful tool to study the conformer distribution of IDPs. However, most generic protein force fields were found to be insufficient in simulations of IDPs. Here we report our development for the CHARMM community. Our residue-specific IDP force field (CHARMM36IDPSFF) was developed based on the base generic force field with CMAP corrections of for all 20 naturally occurring amino acids. Multiple tests show that the simulated chemical shifts with the newly developed force field are in quantitative agreement with NMR experiment and are more accurate than the base generic force field. Comparison of J-couplings with previous work shows that CHARMM36IDPSFF and its corresponding base generic force field have their own advantages. In addition, CHARMM36IDPSFF simulations also agree with experiment for SAXS profiles and radii of gyration of IDPs. Detailed analysis shows that CHARMM36IDPSFF can sample more diverse and disordered conformers. These findings confirm that the newly developed force field can improve the balance of accuracy and efficiency for the conformer sampling of IDPs. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
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TrOn: an anatomical ontology for the beetle Tribolium castaneum.
Dönitz, Jürgen; Grossmann, Daniela; Schild, Inga; Schmitt-Engel, Christian; Bradler, Sven; Prpic, Nikola-Michael; Bucher, Gregor
2013-01-01
In a morphological ontology the expert's knowledge is represented in terms, which describe morphological structures and how these structures relate to each other. With the assistance of ontologies this expert knowledge is made processable by machines, through a formal and standardized representation of terms and their relations to each other. The red flour beetle Tribolium castaneum, a representative of the most species rich animal taxon on earth (the Coleoptera), is an emerging model organism for development, evolution, physiology, and pest control. In order to foster Tribolium research, we have initiated the Tribolium Ontology (TrOn), which describes the morphology of the red flour beetle. The content of this ontology comprises so far most external morphological structures as well as some internal ones. All modeled structures are consistently annotated for the developmental stages larva, pupa and adult. In TrOn all terms are grouped into three categories: Generic terms represent morphological structures, which are independent of a developmental stage. In contrast, downstream of such terms are concrete terms which stand for a dissectible structure of a beetle at a specific life stage. Finally, there are mixed terms describing structures that are only found at one developmental stage. These terms combine the characteristics of generic and concrete terms with features of both. These annotation principles take into account the changing morphology of the beetle during development and provide generic terms to be used in applications or for cross linking with other ontologies and data resources. We use the ontology for implementing an intuitive search function at the electronic iBeetle-Base, which stores morphological defects found in a genome wide RNA interference (RNAi) screen. The ontology is available for download at http://ibeetle-base.uni-goettingen.de.
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Generic health/safety/environment cases
DOE Office of Scientific and Technical Information (OSTI.GOV)
Kelland, A.N.; Primrose, M.; Pickles, J.C.
1996-12-31
A desire to implement HSE Management Systems including HSE Cases in all Shell companies operations prompted the development of a relational data base software package (THESIS) to provide a structured way of preparing an HSE Case. The software includes features which facilitate the management of {open_quotes}Keeping the Case Alive{close_quotes}, enabling the dissemination of tasks and hazard information to the workplace. During the software development it was recognized that a significant reduction could be made in the resources which would be required to prepare an HSE Case for each and every operation by the building of {open_quotes}Generic HSE Cases{close_quotes} addressing specificmore » activities which were repeated across the Company`s operations. This was recognized to be particularly valid for the smaller Single String Venture type of operations. The activities selected for the initial Generic HSE Case development include Land Drilling Operations, Land Seismic Acquisition, and Land Transport. To establish the Generic HSE Case, the THESIS data base is populated with data for a generic operation, identifying all the hazards and activities associated with that operation including all the associated controls, with established formats for the textual sections. In effect, the Generic Case defines the standards required for that type of operation. To generate an operation specific HSE Case, the Generic Case thereafter requires to be modified/adapted so that it represents the actual situation in the operation which it defines. This process includes itemization of all the operation specific details, and may involve the inclusion/deletion of any additional/existing activities or hazards together with their associated controls.« less
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Hartung, Daniel M; Middleton, Luke; Svoboda, Leanne; McGregor, Jessina C
2012-08-01
Controversy exists about the safety of substituting generic antiepileptic drugs (AEDs). Lamotrigine, the prototypical newer AED, is often used for psychiatric and neurological conditions other than epilepsy. The safety of generic substitution of lamotrigine in diverse populations of AED users is unclear. The objective of this study was to evaluate potential associations between generic substitution of lamotrigine and adverse consequences in a population of diverse users of this drug. This study was a retrospective cohort-crossover design using state Medicaid claims data from July 2006 through June 2009. Subjects were included in the cohort if they converted from brand to generic lamotrigine and had 2 years of lamotrigine use prior to conversion. The frequency of emergency department (ED) visits, hospitalizations and condition-specific ED visits or hospitalizations were recorded in the 60 days immediately following the conversion to generic lamotrigine, then compared with the incidence of the same events during a randomly selected time period indexed to one of the patient's past refills of branded lamotrigine. Multivariate conditional logistic regression was used to quantify the association between generic conversion and health services utilization while controlling for changes in lamotrigine dose and concurrent drug use. Of the 616 unique subjects included in this analysis, epilepsy was the most common diagnosis (41%), followed by bipolar disorder (32%), pain (30%) and migraine (18%). Conversion to generic lamotrigine was not associated with a statistically significant increase in the odds of an ED visit (adjusted odds ratio [AOR] = 1.35; 95% confidence interval [CI] 0.92, 1.97), hospitalization (AOR = 1.21; 95% CI 0.60, 2.50) or condition-specific encounter (AOR 1.75; 95 CI 0.87, 3.51). A statistically significant increase in ED visits, hospitalizations or condition-specific encounters was not observed following the switch from brand to generic lamotrigine, although a type II error cannot be ruled out.
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Catoni, Nicholas
2015-01-01
Abstract High-frequency oscillations (HFOs) are an intriguing potential biomarker for epilepsy, typically categorized according to peak frequency as either ripples (100–250 Hz) or fast ripples (>250 Hz). In the hippocampus, fast ripples were originally thought to be more specific to epileptic tissue, but it is still very difficult to distinguish which HFOs are caused by normal versus pathological brain activity. In this study, we use a computational model of hippocampus to investigate possible network mechanisms underpinning normal ripples, pathological ripples, and fast ripples. Our results unify several prior findings regarding HFO mechanisms, and also make several new predictions regarding abnormal HFOs. We show that HFOs are generic, emergent phenomena whose characteristics reflect a wide range of connectivity and network input. Although produced by different mechanisms, both normal and abnormal HFOs generate similar ripple frequencies, underscoring that peak frequency is unable to distinguish the two. Abnormal ripples are generic phenomena that arise when input to pyramidal cells overcomes network inhibition, resulting in high-frequency, uncoordinated firing. In addition, fast ripples transiently and sporadically arise from the precise conditions that produce abnormal ripples. Lastly, we show that such abnormal conditions do not require any specific network structure to produce coherent HFOs, as even completely asynchronous activity is capable of producing abnormal ripples and fast ripples in this manner. These results provide a generic, network-based explanation for the link between pathological ripples and fast ripples, and a unifying description for the entire spectrum from normal ripples to pathological fast ripples. PMID:26146658
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Herbaut, Mickaël; Zoghlami, Aya; Habrant, Anouck; Falourd, Xavier; Foucat, Loïc; Chabbert, Brigitte; Paës, Gabriel
2018-01-01
Biomass recalcitrance to enzymatic hydrolysis has been assigned to several structural and chemical factors. However, their relative importance remains challenging to evaluate. Three representative biomass species (wheat straw, poplar and miscanthus) were submitted to four standard pretreatments (dilute acid, hot water, ionic liquid and sodium chlorite) in order to generate a set of contrasted samples. A large array of techniques, including wet chemistry analysis, porosity measurements using NMR spectroscopy, electron and fluorescence microscopy, were used in order to determine possible generic factors of biomass recalcitrance. The pretreatment conditions selected allowed obtaining samples displaying different susceptibility to enzymatic hydrolysis (from 3 up to 98% of the initial glucose content released after 96 h of saccharification). Generic correlation coefficients were calculated between the measured chemical and structural features and the final saccharification rates. Increases in porosity displayed overall strong positive correlations with saccharification efficiency, but different porosity ranges were concerned depending on the considered biomass. Lignin-related factors displayed highly negative coefficients for all biomasses. Lignin content, which is likely involved in the correlations observed for porosity, was less detrimental to enzymatic hydrolysis than lignin composition. Lignin influence was highlighted by the strong negative correlation with fluorescence intensity which mainly originates from monolignols in mature tissues. Our results provide a better understanding of the factors responsible for biomass recalcitrance that can reasonably be considered as generic. The correlations with specific porosity ranges are biomass species-dependent, meaning that enzymes cocktails with fitted enzyme size are likely to be needed to optimise saccharification depending on the biomass origin. Lignin composition, which probably influences its structure, is the most important parameter to overcome to enhance enzymes access to the polysaccharides. Accordingly, fluorescence intensity was found to be a rapid and simple method to assess recalcitrance after pretreatment.
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A Multifunctional Hot Structure Heatshield Concept for Planetary Entry
NASA Technical Reports Server (NTRS)
Walker, Sandra P.; Daryabeigi, Kamran; Samareh, Jamshid A.; Wagner, Robert; Waters, Allen
2015-01-01
A multifunctional hot structure heatshield concept is being developed to provide technology enhancements with significant benefits compared to the current state-of-the-art heatshield technology. These benefits can potentially enable future planetary missions. The concept is unique in integrating the function of the thermal protection system with the primary load carrying structural component. An advanced carbon-carbon material system has been evaluated for the load carrying structure, which will be utilized on the outer surface of the heatshield, and thus will operate as a hot structure exposed to the severe aerodynamic heating associated with planetary entry. Flexible, highly efficient blanket insulation is sized for use underneath the hot structure to maintain required operational internal temperatures. The approach followed includes developing preliminary designs to demonstrate feasibility of the concept and benefits over a traditional, baseline design. Where prior work focused on a concept for an Earth entry vehicle, the current efforts presented here are focused on developing a generic heatshield model and performing a trade study for a Mars entry application. This trade study includes both structural and thermal evaluation. The results indicate that a hot structure concept is a feasible alternative to traditional heatshields and may offer advantages that can enable future entry missions.
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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.
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A Generic Mesh Data Structure with Parallel Applications
ERIC Educational Resources Information Center
Cochran, William Kenneth, Jr.
2009-01-01
High performance, massively-parallel multi-physics simulations are built on efficient mesh data structures. Most data structures are designed from the bottom up, focusing on the implementation of linear algebra routines. In this thesis, we explore a top-down approach to design, evaluating the various needs of many aspects of simulation, not just…
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BLAST for Behind-the-Meter Applications Lite Tool | Transportation Research
provided by NREL's PV Watts calculator. A generic utility rate structure framework makes it possible to the BLAST documentation for proper CSV formatting. Rate structure values Define demand charges and energy costs to best represent your utility rate structure of interest. Demand charges and energy costs
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SGML Authoring Tools for Technical Communication.
ERIC Educational Resources Information Center
Davidson, W. J.
1993-01-01
Explains that structured authoring systems designed for the creation of generically encoded reusable information have context-sensitive application of markup, markup suppression, queing and automated formatting, structural navigation, and self-validation features. Maintains that they are a real alternative to conventional publishing systems. (SR)
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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
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Comparison of main-shock and aftershock fragility curves developed for New Zealand and US buildings
Uma, S.R.; Ryu, H.; Luco, N.; Liel, A.B.; Raghunandan, M.
2011-01-01
Seismic risk assessment involves the development of fragility functions to express the relationship between ground motion intensity and damage potential. In evaluating the risk associated with the building inventory in a region, it is essential to capture 'actual' characteristics of the buildings and group them so that 'generic building types' can be generated for further analysis of their damage potential. Variations in building characteristics across regions/countries largely influence the resulting fragility functions, such that building models are unsuitable to be adopted for risk assessment in any other region where a different set of building is present. In this paper, for a given building type (represented in terms of height and structural system), typical New Zealand and US building models are considered to illustrate the differences in structural model parameters and their effects on resulting fragility functions for a set of main-shocks and aftershocks. From this study, the general conclusion is that the methodology and assumptions used to derive basic capacity curve parameters have a considerable influence on fragility curves.
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Duru, O Kenrik; Ettner, Susan L; Turk, Norman; Mangione, Carol M; Brown, Arleen F; Fu, Jeffery; Simien, Leslie; Tseng, Chien-Wen
2014-01-01
Drug substitution is a promising approach to reducing medication costs. To calculate the potential savings in a Medicare Part D plan from generic or therapeutic substitution for commonly prescribed drugs. Cross-sectional, simulation analysis. Low-income subsidy (LIS) beneficiaries (n = 145,056) and non low-income subsidy (non-LIS) beneficiaries (n = 1,040,030) enrolled in a large, national Part D health insurer in 2007 and eligible for a possible substitution. Using administrative data from 2007, we identified claims filled for brand-name drugs for which a direct generic substitute was available. We also identified the 50 highest cost drugs separately for LIS and non-LIS beneficiaries, and reached consensus on which drugs had possible therapeutic substitutes (27 for LIS, 30 for non-LIS). For each possible substitution, we used average daily costs of the original and substitute drugs to calculate the potential out-of-pocket savings, health plan savings, and when applicable, savings for the government/LIS subsidy. Overall, 39 % of LIS beneficiaries and 51 % of non-LIS beneficiaries were eligible for a generic and/or therapeutic substitution. Generic substitutions resulted in an average annual savings of $160 in the case of LIS beneficiaries and $127 in the case of non-LIS beneficiaries. Therapeutic substitutions resulted in an average annual savings of $452 in the case of LIS beneficiaries and $389 in the case of non-LIS beneficiaries. Our findings indicate that drug substitution, particularly therapeutic substitution, could result in significant cost savings. There is a need for additional studies evaluating the acceptability of therapeutic substitution interventions within Medicare Part D.
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Meier, Frederick A; Badrick, Tony C; Sikaris, Kenneth A
2018-02-17
For 50 years, structure, process, and outcomes measures have assessed health care quality. For clinical laboratories, structural quality has generally been assessed by inspection. For assessing process, quality indicators (QIs), statistical monitors of steps in the clinical laboratory total testing, have proliferated across the globe. Connections between structural and process laboratory measures and patient outcomes, however, have rarely been demonstrated. To inform further development of clinical laboratory quality systems, we conducted a selective but worldwide review of publications on clinical laboratory quality assessment. Some QIs, like seven generic College of American Pathologists Q-Tracks monitors, have demonstrated significant process improvement; other measures have uncovered critical opportunities to improve test selection and result management. The College of Pathologists of Australasia Key Indicator Monitoring and Management System has deployed risk calculations, introduced from failure mode effects analysis, as surrogate measures for outcomes. Showing economic value from clinical laboratory testing quality is a challenge. Clinical laboratories should converge on fewer (7-14) rather than more (21-35) process monitors; monitors should cover all steps of the testing process under laboratory control and include especially high-risk specimen-quality QIs. Clinical laboratory stewardship, the combination of education interventions among clinician test orderers and report consumers with revision of test order formats and result reporting schemes, improves test ordering, but improving result reception is more difficult. Risk calculation reorders the importance of quality monitors by balancing three probabilities: defect frequency, weight of potential harm, and detection difficulty. The triple approach of (1) a more focused suite of generic consensus quality indicators, (2) more active clinical laboratory testing stewardship, and (3) integration of formal risk assessment, rather than competing with economic value, enhances it.
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A visual interface for generic message translation
DOE Office of Scientific and Technical Information (OSTI.GOV)
Blattner, M.M.; Kou, L.T.; Carlson, J.W.
1988-06-21
This paper is concerned with the translation of data structures we call messages. Messages are an example of a type of data structure encountered in generic data translation. Our objective is to provide a system that the nonprogrammer can use to specify the nature of translations from one type to another. For this reason we selected a visual interface that uses interaction techniques that do not require a knowledge of programming or command languages. The translator must accomplish two tasks: create a mapping between fields in different message types that specifies which fields have similar semantic content, and reformat ormore » translate data specifications within those fields. The translations are accomplished with appropriate, but different, visual metaphors. 14 refs., 4 figs.« less
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Dynamic competition in pharmaceuticals. Patent expiry, generic penetration, and industry structure.
Magazzini, Laura; Pammolli, Fabio; Riccaboni, Massimo
2004-06-01
This paper investigates patterns of industrial dynamics and competition in the pharmaceutical industry, with particular reference to the consequences of patent expiry in different countries. We focus on the competition at the level of single chemical entities, distinguishing between original brands and generic products. Quarterly data, spanning from July 1987 to December 1998, on sales of pharmaceutical products in four countries (USA, UK, Germany, and France) constitute the basis of our analysis. All the products containing major molecules whose patent expiration date lies between 1986 and 1996 are included in our sample. We show how diffusion of generics is linked to the characteristics of the market and investigate how price dynamics of original products are affected by generic competition. Our empirical investigation shows that the dynamics of drug prices and the competition by generic drugs vary significantly across countries. This heterogeneity notwithstanding, a clear distinction seems to emerge. On the one hand, systems that rely on market-based competition in pharmaceuticals promote a clear distinction between firms that act as innovators and firms that act as imitators after patent expiry. Here, original products enjoy premium prices and exclusivity profits under patent protection, and face fierce price competition after patent expiry. On the other hand, in systems that rely on administered prices, penetration by generic drugs tends to be rather limited. Its descriptive and preliminary nature notwithstanding, our analysis seems to have relevant implications at different levels of generality, especially for Europe.
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OTV propulsion tecnology programmatic overview
NASA Astrophysics Data System (ADS)
Cooper, L. P.
1984-04-01
An advanced orbit transfer vehicles (OTV) which will be an integral part of the national space transportation system to carry men and cargo between low Earth orbit and geosynchronous orbit will perform planetary transfers and deliver large acceleration limited space structures to high Earth orbits is reviewed. The establishment of an advanced propulsion technology base for an OTV for the mid 1990's is outlined. The program supports technology for three unique engine concepts. Work is conducted to generic technologies which benefit all three concepts and specific technology which benefits only one of the concepts. Concept and technology definitions to identify propulsion innovations, and subcomponent research to explore and validate their potential benefits are included.
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Generic Bistability in Creased Conical Surfaces
NASA Astrophysics Data System (ADS)
Lechenault, F.; Adda-Bedia, M.
2015-12-01
The emerging field of mechanical metamaterials has sought inspiration in the ancient art of origami as archetypal deployable structures that carry geometric rigidity, exhibit exotic material properties, and are potentially scalable. A promising venue to introduce functionality consists in coupling the elasticity of the sheet and the kinematics of the folds. In this spirit, we introduce a scale-free, analytical description of a very general class of snap-through, bistable patterns of creases naturally occurring at the vertices of real origami that can be used as building blocks to program and actuate the overall shape of the decorated sheet. These switches appear at the simplest possible level of creasing and admit straightforward experimental realizations.
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OTV propulsion tecnology programmatic overview
NASA Technical Reports Server (NTRS)
Cooper, L. P.
1984-01-01
An advanced orbit transfer vehicles (OTV) which will be an integral part of the national space transportation system to carry men and cargo between low Earth orbit and geosynchronous orbit will perform planetary transfers and deliver large acceleration limited space structures to high Earth orbits is reviewed. The establishment of an advanced propulsion technology base for an OTV for the mid 1990's is outlined. The program supports technology for three unique engine concepts. Work is conducted to generic technologies which benefit all three concepts and specific technology which benefits only one of the concepts. Concept and technology definitions to identify propulsion innovations, and subcomponent research to explore and validate their potential benefits are included.
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Estimation of Potential Savings Through Therapeutic Substitution.
Johansen, Michael E; Richardson, Caroline
2016-06-01
Therapeutic substitution offers potential to decrease pharmaceutical expenditures and potentially improve the efficiency of the health care system. To estimate potential savings through therapeutic substitution in terms of both overall and out-of-pocket expenditures of branded drugs when a generic in the same class with the same indication was available. Repeated cross-sectional study using the 107 132 individuals included in the nationally representative Medical Expenditure Panel Survey (2010-2012) along with their reported prescribed medicine use. The Orange Book, company financial statements, US Food and Drug Administration records, and published research were used for adjunctive information. Estimated excess expenditure due to branded drug overuse when a lower-cost generic in the same class with the same indication was available. The study included 107 132 individuals between 2010 and 2012, of whom 62.1% (95% CI, 61.4%-62.8%) reported use of any prescribed medicine. A total of 31.5% (95% CI, 30.7%-32.2%) used a medication from an included drug class, whereas 16.6% (95% CI, 16.0%-17.1%) of the population used a branded drug from the included classes compared with 24.0% (95% CI, 23.4%-24.7%) who used a generic and 9.1% (95% CI, 8.7%-9.4%) who used both. In the included drug classes, the majority of the drugs were generics, with a total of 93.5 billion standardized doses compared with 47.4 billion standardized doses of branded drugs. Total expenditure of the branded drugs accounted for $147 (95% CI, $137-$156) billion compared with $62.7 (95% CI, $58.9-$66.5) billion for the generics. Between 2010 and 2012, an estimated $73.0 (95% CI, $67.6-$78.5) billion in total excess expenditure and $24.6 (95% CI, $22.6-$26.5) billion in out-of-pocket excess expenditure was attributable to branded drug overuse. The excess was present across numerous drug classes throughout many aspects of medicine and equates to 9.6% of total and 14.1% of out-of-pocket prescribed medicine expenses. The drug classes with the highest excess expenditure included statins ($10.9 [SE, $0.41] billion), atypical antipsychotics ($9.99 [SE, $1.03] billion), proton pump inhibitors ($6.12 [SE, $0.38] billion), selective serotonin reuptake inhibitors ($6.08 [SE, $0.49] billion), and angiotensin receptor blockers ($5.53 [SE, $0.35] billion). Although therapeutic substitution is controversial, it offers a potential mechanism to significantly decrease drug costs if it can be implemented in a way that does not negatively affect quality of care.
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NASA Astrophysics Data System (ADS)
Meyer, Sam; Everaers, Ralf
2015-02-01
The histone-DNA interaction in the nucleosome is a fundamental mechanism of genomic compaction and regulation, which remains largely unknown despite increasing structural knowledge of the complex. In this paper, we propose a framework for the extraction of a nanoscale histone-DNA force-field from a collection of high-resolution structures, which may be adapted to a larger class of protein-DNA complexes. We applied the procedure to a large crystallographic database extended by snapshots from molecular dynamics simulations. The comparison of the structural models first shows that, at histone-DNA contact sites, the DNA base-pairs are shifted outwards locally, consistent with locally repulsive forces exerted by the histones. The second step shows that the various force profiles of the structures under analysis derive locally from a unique, sequence-independent, quadratic repulsive force-field, while the sequence preferences are entirely due to internal DNA mechanics. We have thus obtained the first knowledge-derived nanoscale interaction potential for histone-DNA in the nucleosome. The conformations obtained by relaxation of nucleosomal DNA with high-affinity sequences in this potential accurately reproduce the experimental values of binding preferences. Finally we address the more generic binding mechanisms relevant to the 80% genomic sequences incorporated in nucleosomes, by computing the conformation of nucleosomal DNA with sequence-averaged properties. This conformation differs from those found in crystals, and the analysis suggests that repulsive histone forces are related to local stretch tension in nucleosomal DNA, mostly between adjacent contact points. This tension could play a role in the stability of the complex.
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Liu, Ya-Ming; Ou, Huang-Tz; Yang, Yen-Kuang
2014-12-01
A health care system in which there is no separation between prescription and dispensation, combined with a regulated prescription drug market, leads to various generic substitution mechanisms for antidepressants. We investigated the determinants of generic versus brand-name antidepressant choices in a regulated prescription market where physicians both prescribe and dispense drugs. Using data from a sample of one million individuals selected randomly from the registry of National Health Insurance beneficiaries in 2010, and all claims for these one million enrollees between January 1997 and December 2011, we employed logistic regression to examine the choice of generic versus brand-name antidepressants in the Taiwanese prescription drug market. Access to various antidepressant brands varies according to the accreditation level and type of ownership of the healthcare provider. Private healthcare providers and those with lower accreditation levels were more likely to prescribe generic antidepressants compared to their brand-name counterparts. The diversity of products and competition in the molecule market was positively associated with the probability of prescribing generic antidepressants. In a regulated prescription drug market with no separation between prescription and dispensation, the substitution of generic antidepressant prescriptions in place of brand-name prescriptions is likely driven by drug and provider market characteristics, rather than by lowering costs. The allocation of different types of ownership and accreditation levels of healthcare providers may lead to unequal access to various brands of antidepressants. Policies for improving the treatment of depression should take into account the structure of molecule and provider markets as important factors in determining the choice and utilization of antidepressants, in a healthcare system where physicians both prescribe and dispense drugs. Other psychotropic drug classes should be investigated to explore the effect of molecule and provider characteristics on the utilization of various classes of medication.
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Internal structure of vortices in a dipolar spinor Bose-Einstein condensate
NASA Astrophysics Data System (ADS)
Borgh, Magnus O.; Lovegrove, Justin; Ruostekoski, Janne
2017-04-01
We demonstrate how dipolar interactions (DI) can have pronounced effects on the structure of vortices in atomic spinor Bose-Einstein condensates and illustrate generic physical principles that apply across dipolar spinor systems. We then find and analyze the cores of singular non-Abelian vortices in a spin-3 52Cr condensate. Using a simpler spin-1 model system, we analyze the underlying dipolar physics and show how a dipolar healing length interacts with the hierarchy of healing lengths of the contact interaction and leads to simple criteria for the core structure: vortex core size is restricted to the shorter spin-dependent healing length when the interactions both favor the ground-state spin condition, but can conversely be enlarged by DI when interactions compete. We further demonstrate manifestations of spin-ordering induced by the DI anisotropy, including DI-dependent angular momentum of nonsingular vortices, as a result of competition with adaptation to rotation, and potentially observable internal vortex-core spin textures. We acknowledge financial support from the EPSRC.
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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.
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New Product Development in the Pharmaceutical Industry: Evidence from a generic market.
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.
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New Product Development in the Pharmaceutical Industry: Evidence from a generic market
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
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Glauser, Bianca F; Vairo, Bruno C; Oliveira, Stephan-Nicollas M C G; Cinelli, Leonardo P; Pereira, Mariana S; Mourão, Paulo A S
2012-02-01
Patent protection for enoxaparin has expired. Generic preparations are developed and approved for clinical use in different countries. However, there is still skepticism about the possibility of making an exact copy of the original drug due to the complex processes involved in generating low-molecular-weight heparins. We have undertaken a careful analysis of generic versions of enoxaparin available for clinical use in Brazil. Thirty-three batches of active ingredient and 70 of the final pharmaceutical product were obtained from six different suppliers. They were analysed for their chemical composition, molecular size distribution, in vitro anticoagulant activity and pharmacological effects on animal models of experimental thrombosis and bleeding. Clearly, the generic versions of enoxaparin available for clinical use in Brazil are similar to the original drug. Only three out of 33 batches of active ingredient from one supplier showed differences in molecular size distribution, resulting from a low percentage of tetrasaccharide or the presence of a minor component eluted as monosaccharide. Three out of 70 batches of the final pharmaceutical products contained lower amounts of the active ingredient than that declared by the suppliers. Our results suggest that the generic versions of enoxaparin are a viable therapeutic option, but their use requires strict regulations to ensure accurate standards.
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2012-01-01
Background Epidemiological research often requires collection of data from a representative sample of the community or recruitment of specific groups through broad community approaches. The population coverage of traditional survey methods such as mail-outs to residential addresses, and telephone contact via public directories or random-digit-dialing is declining and survey response rates are falling. There is a need to explore new sampling frames and consider multiple response modes including those offered by changes in telecommunications and internet technology. Methods We evaluated response rates and cost-effectiveness for three modes of survey administration (postal invitation/postal survey, postal invitation/internet survey and postal invitation/telephone survey) and two styles of contact approach (personalised and generic) in a community survey of greywater use. Potential respondents were contacted only once, with no follow up of non-responders. Results The telephone survey produced the highest adjusted response rate (30.2%), followed by the personalised postal survey (10.5%), generic postal survey (7.5%) and then the internet survey (4.7% for the personalised approach and 2.2% for the generic approach). There were some differences in household characteristics and greywater use rates between respondents to different survey modes, and between respondents to personalised and generic approaches. These may be attributable to the differing levels of motivations needed for a response, and varying levels of interest in the survey topic among greywater users and non-users. The generic postal survey had the lowest costs per valid survey received (Australian $22.93), followed by the personalised postal survey ($24.75). Conclusions Our findings suggest that postal surveys currently remain the most economic option for population-based studies, with similar costs for personalised and generic approaches. Internet surveys may be effective for specialised groups where email lists are available for initial contact, but barriers other than household internet access still exist for community-based surveys. Given the increasing recruitment challenges facing community-based studies, there is an imperative to gather contemporary comparative data on different survey modes and recruitment approaches in order to determine their strengths, limitations and costs. Researchers also need to document and report on the potential biases in the target and respondent populations and how this may affect the data collected. PMID:22938205
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Brand Medications and Medicare Part D: How Eye Care Providers' Prescribing Patterns Influence Costs.
Newman-Casey, Paula Anne; Woodward, Maria A; Niziol, Leslie M; Lee, Paul P; De Lott, Lindsey B
2018-03-01
To quantify costs of eye care providers' Medicare Part D prescribing patterns for ophthalmic medications and to estimate the potential savings of generic or therapeutic drug substitutions and price negotiation. Retrospective cross-sectional study. Eye care providers prescribing medications through Medicare Part D in 2013. Medicare Part D 2013 prescriber public use file and summary file were used to calculate medication costs by physician specialty and drug. Savings from generic or therapeutic drug substitutions were estimated for brand drugs. The potential savings from price negotiation was estimated using drug prices negotiated by the United States Veterans Administration (USVA). Total cost of brand and generic medications prescribed by eye care providers. Eye care providers accounted for $2.4 billion in total Medicare part D prescription drug costs and generated the highest percentage of brand name medication claims compared with all other providers. Brand medications accounted for a significantly higher proportion of monthly supplies by volume, and therefore, also by total cost for eye care providers compared with all other providers (38% vs. 23% by volume, P < 0.001; 79% vs. 56% by total cost, P < 0.001). The total cost attributable to eye care providers is driven by glaucoma medications, accounting for $1.2 billion (54% of total cost; 72% of total volume). The second costliest category, dry eye medications, was attributable mostly to a single medication, cyclosporine ophthalmic emulsion (Restasis, Allergan, Irvine, CA), which has no generic alternative, accounting for $371 million (17% of total cost; 4% of total volume). If generic medications were substituted for brand medications when available, $148 million would be saved (7% savings); if generic and therapeutic substitutions were made, $882 million would be saved (42% savings). If Medicare negotiated the prices for ophthalmic medications at USVA rates, $1.09 billion would be saved (53% savings). Eye care providers prescribe more brand medications by volume than any other provider group. Efforts to reduce prescription expenditures by eye care providers should focus on increasing the use of generic medications, primarily through therapeutic substitutions. Policy changes enabling Medicare to negotiate prescription drug prices could decrease costs to Medicare. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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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
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Quality of generic medicines in South Africa: perceptions versus reality - a qualitative study.
Patel, Aarti; Gauld, Robin; Norris, Pauline; Rades, Thomas
2012-09-03
Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines must be addressed to ensure that people use them with confidence. Campaigns to increase the uptake of generic medicines by consumers and providers of healthcare need to be informed by local norms and practices. This study sought to compare South African consumers' and healthcare providers' perceptions of quality of generics to the actual quality of selected products. The study was conducted at the local level in three cities of South Africa: Johannesburg, Durban and Cape Town. Purposive sampling was used to recruit consumer participants (n = 73) and random sampling used to recruit healthcare providers from public and private sectors (n = 15). Data were obtained through twelve focus group discussions with consumers and semi-structured interviews (n = 15) with healthcare providers in order to gain familiarity with perceptions of quality. One hundred and thirty five products comprising paracetamol tablets (n = 47), amoxicillin capsules (n = 45) and hydrochlorothiazide tablets (n = 43) were sourced from public and private sector healthcare providers. These products were subjected to in vitro dissolution, uniformity of weight and identity (Fourier Transformed Infrared Spectroscopy) tests using prescribed methods from the British (2005) and United States Pharmacopeias (2006). Respondents described drug quality in relation to the effect on symptoms. Procurement and use behavior of healthcare providers was influenced by prior experience, manufacturers' names and consumers' ability to pay. All formulations passed the in vitro tests for quality. This study showed clear differences between perceptions of quality and actual quality of medicines suggesting deficiencies in public engagement by government regarding the implementation of generic medicines policy. Implementation of generic medicines policy requires the involvement of consumers and healthcare providers to specifically address their information gaps and needs.
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Quality of generic medicines in South Africa: Perceptions versus Reality – A qualitative study
2012-01-01
Background Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines must be addressed to ensure that people use them with confidence. Campaigns to increase the uptake of generic medicines by consumers and providers of healthcare need to be informed by local norms and practices. This study sought to compare South African consumers’ and healthcare providers’ perceptions of quality of generics to the actual quality of selected products. Methods The study was conducted at the local level in three cities of South Africa: Johannesburg, Durban and Cape Town. Purposive sampling was used to recruit consumer participants (n = 73) and random sampling used to recruit healthcare providers from public and private sectors (n = 15). Data were obtained through twelve focus group discussions with consumers and semi-structured interviews (n = 15) with healthcare providers in order to gain familiarity with perceptions of quality. One hundred and thirty five products comprising paracetamol tablets (n = 47), amoxicillin capsules (n = 45) and hydrochlorothiazide tablets (n = 43) were sourced from public and private sector healthcare providers. These products were subjected to in vitro dissolution, uniformity of weight and identity (Fourier Transformed Infrared Spectroscopy) tests using prescribed methods from the British (2005) and United States Pharmacopeias (2006). Results Respondents described drug quality in relation to the effect on symptoms. Procurement and use behavior of healthcare providers was influenced by prior experience, manufacturers’ names and consumers’ ability to pay. All formulations passed the in vitro tests for quality. Conclusions This study showed clear differences between perceptions of quality and actual quality of medicines suggesting deficiencies in public engagement by government regarding the implementation of generic medicines policy. Implementation of generic medicines policy requires the involvement of consumers and healthcare providers to specifically address their information gaps and needs. PMID:22943592
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Medicare Part D Payments for Topical Steroids
Song, Hannah; Adamson, Adewole
2017-01-01
Importance Rising pharmaceutical costs in the United States are an increasing source of financial burden for payers and patients. Although topical steroids are among the most commonly prescribed medications in dermatology, there are limited data on steroid-related spending and utilization. Objective To characterize Medicare and patient out-of-pocket costs for topical steroids, and to model potential savings that could result from substitution of the cheapest topical steroid from the corresponding potency class. Design, Setting, and Participants This study was a retrospective cost analysis of the Medicare Part D Prescriber Public Use File, which details annual drug utilization and spending on both generic and branded drugs from 2011 to 2015 by Medicare Part D participants who filled prescriptions for topical steroids. Main Outcomes and Measures Total and potential Medicare and out-of-pocket patient spending. Costs were adjusted for inflation and reported in 2015 dollars. Results Medicare Part D expenditures on topical steroids between 2011 and 2015 were $2.3 billion. Patients’ out-of-pocket spending for topical steroids over the same period was $333.7 million. The total annual spending increased from $237.6 million to $775.9 million, an increase of 226.5%. Patients’ annual out-of-pocket spending increased from $41.4 million to $101.8 million, an increase of 145.9%. The total number of prescriptions were 7.7 million in 2011 and 10.6 million in 2015, an increase of 37.0%. Generic medication costs accounted for 97.8% of the total spending during this time period. The potential health care savings and out-of-pocket patient savings from substitution of the cheapest topical steroid within the corresponding potency class were $944.8 million and $66.6 million, respectively. Conclusions and Relevance Most topical steroids prescribed were generic drugs. There has been a sharp increase in Medicare and out-of-pocket spending on topical steroids that is driven by higher costs for generics. Use of clinical decision support tools to enable substitution of the most affordable generic topical steroid from the corresponding potency class may reduce drug expenditures. PMID:28453645
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Witness recall across repeated interviews in a case of repeated abuse.
Brubacher, Sonja P; La Rooy, David
2014-02-01
In this illustrative case study we examine the three forensic interviews of a girl who experienced repeated sexual abuse from ages 7 to 11. She disclosed the abuse after watching a serialized television show that contained a storyline similar to her own experience. This triggered an investigation that ended in successful prosecution of the offender. Because this case involved abuse that was repeated on a weekly basis for 4 years we thus investigated the degree to which the child's narrative reflected specific episodes or generic accounts, and both the interviewer's and child's attempts to elicit and provide, respectively, specific details across the 3 interviews collected in a 1 month period. Across the 3 interviews, the child's account was largely generic, yet on a number of occasions she provided details specific to individual incidents (episodic leads) that could have been probed further. As predicted: earlier interviews were characterized more by episodic than generic prompts and the reverse was true for the third interview; the child often responded using the same style of language (episodic or generic) as the interviewer; and open questions yielded narrative information. We discuss the importance of adopting children's words to specify occurrences, and the potential benefits of permitting generic recall in investigative interviews on children's ability to provide episodic leads. Despite the fact that the testimony was characterized by generic information about what usually happened, rather than specific episodic details about individual occurrences, this case resulted in successful prosecution. Copyright © 2013 Elsevier Ltd. All rights reserved.
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Migration of the CERN IT Data Centre Support System to ServiceNow
NASA Astrophysics Data System (ADS)
Alvarez Alonso, R.; Arneodo, G.; Barring, O.; Bonfillou, E.; Coelho dos Santos, M.; Dore, V.; Lefebure, V.; Fedorko, I.; Grossir, A.; Hefferman, J.; Mendez Lorenzo, P.; Moller, M.; Pera Mira, O.; Salter, W.; Trevisani, F.; Toteva, Z.
2014-06-01
The large potential and flexibility of the ServiceNow infrastructure based on "best practises" methods is allowing the migration of some of the ticketing systems traditionally used for the monitoring of the servers and services available at the CERN IT Computer Centre. This migration enables the standardization and globalization of the ticketing and control systems implementing a generic system extensible to other departments and users. One of the activities of the Service Management project together with the Computing Facilities group has been the migration of the ITCM structure based on Remedy to ServiceNow within the context of one of the ITIL processes called Event Management. The experience gained during the first months of operation has been instrumental towards the migration to ServiceNow of other service monitoring systems and databases. The usage of this structure is also extended to the service tracking at the Wigner Centre in Budapest.
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Quantum no-scale regimes in string theory
NASA Astrophysics Data System (ADS)
Coudarchet, Thibaut; Fleming, Claude; Partouche, Hervé
2018-05-01
We show that in generic no-scale models in string theory, the flat, expanding cosmological evolutions found at the quantum level can be attracted to a "quantum no-scale regime", where the no-scale structure is restored asymptotically. In this regime, the quantum effective potential is dominated by the classical kinetic energies of the no-scale modulus and dilaton. We find that this natural preservation of the classical no-scale structure at the quantum level occurs when the initial conditions of the evolutions sit in a subcritical region of their space. On the contrary, supercritical initial conditions yield solutions that have no analogue at the classical level. The associated intrinsically quantum universes are sentenced to collapse and their histories last finite cosmic times. Our analysis is done at 1-loop, in perturbative heterotic string compactified on tori, with spontaneous supersymmetry breaking implemented by a stringy version of the Scherk-Schwarz mechanism.
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Kim, Jong Man; Kwon, Choon Hyuck David; Joh, Jae-Won; Sinn, Dong Hyun; Choi, Gyu-Seong; Park, Jae Berm; Kang, Eun-Suk; Lee, Suk-Koo
2017-01-01
In this study, peripheral blood lymphocytes were compared between a brand-name and a generic tacrolimus group in stable liver transplant recipients. Sixteen patients who underwent ABO-compatible living donor liver transplants between 2012 and 2013 and had stable graft function were included in this study. Ten patients received brand-name tacrolimus and 6 patients received generic tacrolimus. CD3, CD4, CD8, γδ, CD4+FoxP3+, and CD3-CD56+ T cells were analyzed in peripheral blood obtained preoperatively and 4, 8, 12, and 24 weeks after liver transplantation. Categorical variables were compared using a χ2 test or Fisher exact test, and continuous variables were compared using the Mann-Whitney U test. Regarding the baseline and perioperative characteristics, there were no statistically significant differences between the 2 groups. Immunosuppression also was not different. Subtype analysis of T-cell populations carried out in parallel showed similar levels of CD3, CD4, CD8, and γδT cells with brand-name tacrolimus and generic tacrolimus in stable liver transplant recipients. However, the levels of CD4+Foxp3+ and CD3-CD56+ T cells were higher in the brand-name tacrolimus group than in the generic tacrolimus group 8 weeks after transplantation (p < 0.05). The level of CD4+Foxp3+ T cells was higher in the brand-name tacrolimus group than in the generic tacrolimus group after transplantation. This finding showed that brand-name tacrolimus could have more potential immunosuppressive activity than generic tacrolimus regarding the contribution of CD4+Foxp3+ T cells to graft tolerance in liver transplant recipients. © 2017 S. Karger AG, Basel.
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Kyle, G J; Nissen, L M; Tett, S E
2008-10-01
Pharmaceuticals are big business, reporting strong market growth year after year. The 'gatekeepers' of this market are prescribers of medicines, who are the major target of pharmaceutical companies, utilizing direct and indirect influences. This paper draws on previous research investigating pharmaceutical company prescribing influences to develop a qualitative model demonstrating the synergism between commercial influences on prescribing. The generic model was used to explore a realistic but hypothetical scenario to ascertain the applicability of the model. A generic influence model was developed. The model was readily able to be adapted to reflect a realistic practice scenario. Prescriber awareness of the linkages between various seemingly separate marketing techniques could potentially improve medicines usage in an evidence-based practice paradigm.
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On the Spectra of Real and Complex Lamé Operators
NASA Astrophysics Data System (ADS)
Haese-Hill, William A.; Hallnäs, Martin A.; Veselov, Alexander P.
2017-07-01
We study Lamé operators of the form L = -{d^2}/{dx^2} + m(m+1)ω^2\\wp(ω x+z_0), with m\\in{N} and ω a half-period of \\wp(z). For rectangular period lattices, we can choose ω and z_0 such that the potential is real, periodic and regular. It is known after Ince that the spectrum of the corresponding Lamé operator has a band structure with not more than m gaps. In the first part of the paper, we prove that the opened gaps are precisely the first m ones. In the second part, we study the Lamé spectrum for a generic period lattice when the potential is complex-valued. We concentrate on the m=1 case, when the spectrum consists of two regular analytic arcs, one of which extends to infinity, and briefly discuss the m=2 case, paying particular attention to the rhombic lattices.
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Cost variability of suggested generic treatment alternatives under the Medicare Part D benefit.
Patel, Rajul A; Walberg, Mark P; Tong, Emily; Tan, Florence; Rummel, Ashley E; Woelfel, Joseph A; Carr-Lopez, Sian M; Galal, Suzanne M
2014-03-01
The substitution of generic treatment alternatives for brand-name drugs is a strategy that can help lower Medicare beneficiary out-of-pocket costs. Beginning in 2011, Medicare beneficiaries reaching the coverage gap received a 50% discount on the full drug cost of brand-name medications and a 7% discount on generic medications filled during the gap. This discount will increase until 2020, when beneficiaries will be responsible for 25% of total drug costs during the coverage gap. To examine the cost variability of brand and generic drugs within 4 therapeutic classes before and during the coverage gap for each 2011 California stand-alone prescription drug plan (PDP) and prospective coverage gap costs in 2020 to determine the effects on beneficiary out-of-pocket drug costs. Equivalent doses of brand and generic drugs in the following 4 pharmacological classes were examined: angiotensin II receptor blockers (ARBs), bisphosphonates, HMG-CoA reductase inhibitors (statins), and proton pump inhibitors (PPIs). The full drug cost and patient copay/coinsurance amounts during initial coverage and the coverage gap of each drug was recorded based on information retrieved from the Medicare website. These drug cost data were recorded for 28 California PDPs. The highest cost difference between a brand medication and a Centers for Medicare Medicaid Services (CMS)-suggested generic treatment alternative varied between $110.53 and $195.49 at full cost and between $51.37 and $82.35 in the coverage gap. The lowest cost difference varied between $38.45 and $76.93 at full cost and between -$4.11 and $18.52 during the gap. Medicare beneficiaries can realize significant out-of-pocket cost savings for their drugs by taking CMS-suggested generic treatment alternatives. However, due to larger discounts on brand medications made available through recent changes reducing the coverage gap, the potential dollar savings by taking suggested generic treatment alternatives during the gap is less compelling and will decrease as subsidies increase.
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Buckling Behavior of Long Anisotropic Plates Subjected to Fully Restrained Thermal Expansion
NASA Technical Reports Server (NTRS)
Nemeth, Michael P.
2003-01-01
An approach for synthesizing buckling results and behavior for thin, balanced and unbalanced symmetric laminates that are subjected to uniform heating or cooling and which are fully-restrained against thermal expansion or contraction is presented. This approach uses a nondimensional analysis for infinitely long, flexurally anisotropic plates that are subjected to combined mechanical loads and is based on useful nondimensional parameters. In addition, stiffness-weighted laminate thermal-expansion parameters are derived and used to determine critical temperature changes in terms of physically intuitive mechanical buckling coefficients. The effects of membrane orthotropy and anisotropy are included. Many results are presented for some common laminates that are intended to facilitate a structural designer's transition to the use of the generic buckling design curves that are presented in the paper. Several generic buckling design curves are presented that provide physical insight into buckling response and provide useful design data. Examples are presented that demonstrate the use of generic design curves. The analysis approach and generic results indicate the effects and characteristics of laminate thermal expansion, membrane orthotropy and anisotropy, and flexural orthotropy and anisotropy in a very general, unifying manner.
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Thermal Modeling and Analysis of a Cryogenic Tank Design Exposed to Extreme Heating Profiles
NASA Technical Reports Server (NTRS)
Stephens, Craig A.; Hanna, Gregory J.
1991-01-01
A cryogenic test article, the Generic Research Cryogenic Tank, was designed to qualitatively simulate the thermal response of transatmospheric vehicle fuel tanks exposed to the environment of hypersonic flight. One-dimensional and two-dimensional finite-difference thermal models were developed to simulate the thermal response and assist in the design of the Generic Research Cryogenic Tank. The one-dimensional thermal analysis determined the required insulation thickness to meet the thermal design criteria and located the purge jacket to eliminate the liquefaction of air. The two-dimensional thermal analysis predicted the temperature gradients developed within the pressure-vessel wall, estimated the cryogen boiloff, and showed the effects the ullage condition has on pressure-vessel temperatures. The degree of ullage mixing, location of the applied high-temperature profile, and the purge gas influence on insulation thermal conductivity had significant effects on the thermal behavior of the Generic Research Cryogenic Tank. In addition to analysis results, a description of the Generic Research Cryogenic Tank and the role it will play in future thermal structures and transatmospheric vehicle research at the NASA Dryden Flight Research Facility is presented.
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Kumar, Mahadeo; Kumar, Sharad
2014-11-01
Molecular genetic analysis was performed using random amplified polymorphic DNA (RAPD) on three commonly used laboratory bred rodent genera viz. mouse (Mus musculus), rat (Rattus norvegicus) and guinea pig (Cavia porcellus) as sampled from the breeding colony maintained at the Animal Facility, CSIR-Indian Institute of Toxicology Research, Lucknow. In this study, 60 samples, 20 from each genus, were analyzed for evaluation of genetic structure of rodent stocks based on polymorphic bands using RAPD markers. Thirty five random primers were assessed for RAPD analysis. Out of 35, only 20 primers generated a total of 56.88% polymorphic bands among mice, rats and guinea pigs. The results revealed significantly variant and distinct fingerprint patterns specific to each of the genus. Within-genera analysis, the highest (89.0%) amount of genetic homogeneity was observed in mice samples and the least (79.3%) were observed in guinea pig samples. The amount of genetic homogeneity was observed very high within all genera. The average genetic diversity index observed was low (0.045) for mice and high (0.094) for guinea pigs. The inter-generic distances were maximum (0.8775) between mice and guinea pigs; and the minimum (0.5143) between rats and mice. The study proved that the RAPD markers are useful as genetic markers for assessment of genetic structure as well as inter-generic variability assessments.
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Array structure design handbook for stand alone photovoltaic applications
NASA Technical Reports Server (NTRS)
Didelot, R. C.
1980-01-01
This handbook will permit the user to design a low-cost structure for a variety of photovoltaic system applications under 10 kW. Any presently commercially available photovoltaic modules may be used. Design alternatives are provided for different generic structure types, structural materials, and electric interfaces. The use of a hand-held calculator is sufficient to perform the necessary calculations for the array designs.
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Generic superweak chaos induced by Hall effect
NASA Astrophysics Data System (ADS)
Ben-Harush, Moti; Dana, Itzhack
2016-05-01
We introduce and study the "kicked Hall system" (KHS), i.e., charged particles periodically kicked in the presence of uniform magnetic (B ) and electric (E ) fields that are perpendicular to each other and to the kicking direction. We show that for resonant values of B and E and in the weak-chaos regime of sufficiently small nonintegrability parameter κ (the kicking strength), there exists a generic family of periodic kicking potentials for which the Hall effect from B and E significantly suppresses the weak chaos, replacing it by "superweak" chaos (SWC). This means that the system behaves as if the kicking strength were κ2 rather than κ . For E =0 , SWC is known to be a classical fingerprint of quantum antiresonance, but it occurs under much less generic conditions, in particular only for very special kicking potentials. Manifestations of SWC are a decrease in the instability of periodic orbits and a narrowing of the chaotic layers, relative to the ordinary weak-chaos case. Also, for global SWC, taking place on an infinite "stochastic web" in phase space, the chaotic diffusion on the web is much slower than the weak-chaos one. Thus, the Hall effect can be relatively stabilizing for small κ . In some special cases, the effect is shown to cause ballistic motion for almost all parameter values. The generic global SWC on stochastic webs in the KHS appears to be the two-dimensional closest analog to the Arnol'd web in higher dimensional systems.
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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).
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Clinical outcomes associated with brand-to-generic phenytoin interchange.
Kinikar, Shilpa A; Delate, Thomas; Menaker-Wiener, C Mindy; Bentley, William H
2012-05-01
Concerns that antiepileptic brand-to-generic interchange results in disruption of seizure control are widespread. However, little within-patient evidence exists examining such interchanges. To compare within-patient seizure control before and after the interchange of a branded to a single-source generic phenytoin among patients with seizures in a managed care organization. This was a pre-post, self-controlled, retrospective study. Adults with a history of seizure who used Dilantin Kapseals 100 mg extended phenytoin sodium, USP, capsules and whose therapy was interchanged to Taro Pharmaceuticals' AB-rated generic extended phenytoin sodium capsules, USP, 100 mg between July 2007 and May 2008 were included. Study outcomes included the comparisons of the proportions of patients with at least emergency department (ED) visit/inpatient hospitalization and medical office visit/nonoffice consultation for acute seizure in the 6 months before and after interchange. Outcomes were confirmed with manual chart reviews and adjusted for potential confounding medication use. A total of 222 patients were included in the study. Patients were primarily middle-aged (mean 56 years), equally mixed by sex (47% female); most had nonintractable seizures. The majority of patients (~70%) were on phenytoin as monotherapy and had equivalent rates of purchases for potentially confounding medications in both pre- and postinterchange time periods (all p > 0.05). Low serum concentrations were detected more often in the postinterchange study period (adjusted p < 0.001). Despite this, there were low proportions of patients with confirmed seizure events that resulted in an ED visit/inpatient hospitalization in both pre- and postinterchange periods (both 6.3%, adjusted p = 0.937). The proportion of patients with confirmed seizure events diagnosed at a medical office visit was not significantly different between the preinterchange and postinterchange periods (12.2% vs 11.3%, adjusted p = 0.545). No increased proportion of seizures was observed within patients when branded phenytoin was interchanged to an AB-rated, single-source, generic equivalent. More rigorous studies should be conducted to more thoroughly evaluate patient tolerability and drug efficacy when antiepileptic drugs are interchanged from brand to generic formulations.
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NASA Astrophysics Data System (ADS)
Bahauddin, Shah Mohammad; Mehedi Faruk, Mir
2016-09-01
From the unified statistical thermodynamics of quantum gases, the virial coefficients of ideal Bose and Fermi gases, trapped under generic power law potential are derived systematically. From the general result of virial coefficients, one can produce the known results in d = 3 and d = 2. But more importantly we found that, the virial coefficients of Bose and Fermi gases become identical (except the second virial coefficient, where the sign is different) when the gases are trapped under harmonic potential in d = 1. This result suggests the equivalence between Bose and Fermi gases established in d = 1 (J. Stat. Phys. DOI 10.1007/s10955-015-1344-4). Also, it is found that the virial coefficients of two-dimensional free Bose (Fermi) gas are equal to the virial coefficients of one-dimensional harmonically trapped Bose (Fermi) gas.
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Short, Camille E; Rebar, Amanda L; Vandelanotte, Corneel
2015-08-19
Previous research has shown that the personalisation of study invitations improves response rates in survey-based research. To examine if this finding extends to experimental studies, we examined the impact of personalised study invitation e-mails on the response rates of potentially eligible breast cancer survivors for participation in a 6 month randomised controlled trial testing the efficacy of a physical activity intervention. Potential participants (n = 344) were sent either a personalised email or a generic email. Those sent the personalised email were 1.5 times (95 % CI = 1.18-1.93) more likely to respond than those sent the generic email. These findings suggest that personalisation may be a useful and potentially powerful tool that can be utilised when recruiting participants into experimental studies in order to boost response rates.
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Toward Optimizing VEMP: Calculating VEMP Inhibition Depth With a Generic Template.
Noij, Kimberley S; van Tilburg, Mark J; Herrmann, Barbara S; Marciniak, Piotr; Rauch, Steven D; Guinan, John J
2018-04-05
Cervical vestibular evoked myogenic potentials (cVEMP) indirectly reveal the response of the saccule to acoustic stimuli through the inhibition of sternocleidomastoid muscle electromyographic response. VEMP inhibition depth (VEMPid) is a recently developed metric that estimates the percentage of saccular inhibition. VEMPid provides both normalization and better accuracy at low response levels than amplitude-normalized cVEMPs. Hopefully, VEMPid will aid in the clinical assessment of patients with vestibulopatholgy. To calculate VEMPid a template is needed. In the original method, a subject's own cVEMP was used as the template, but this method can be problematic in patients who do not have robust cVEMP responses. We hypothesize that a "generic" template, created by assembling cVEMPs from healthy subjects, can be used to compute VEMPid, which would facilitate the use of VEMPid in subjects with pathological conditions. A generic template was created by averaging cVEMP responses from 6 normal subjects. To compare VEMPid calculations using a generic versus a subject-specific template, cVEMPs were obtained in 40 healthy subjects using 500, 750, and 1000 Hz tonebursts at sound levels ranging from 98 to 123 dB peSPL. VEMPids were calculated both with the generic template and with the subject's own template. The ability of both templates to determine whether a cVEMP was present or not was compared with receiver operating characteristic curves. No significant differences were found between VEMPid calculations using a generic template versus using a subject-specific template for all frequencies and sound levels. Based on the receiver operating characteristic curves, the subject-specific and generic template did an equally good job at determining threshold. Within limits, the shape of the generic template did not affect these results. A generic template can be used instead of a subject-specific template to calculate VEMPid. Compared with cVEMP normalized by electromyographic amplitudes, VEMPid is advantageous because it averages zero when there is no sound stimulus and it allows the accumulating VEMPid value to be shown during data acquisition as a guide to deciding when enough data has been collected.
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Shaw, K L; Southwood, T R; McDonagh, J E
2007-07-01
To develop a scale to assess satisfaction with transitional health care among adolescents with a chronic illness and their parents. The 'Mind the Gap' scale was developed using evidence from a previous needs assessment, in three stages: (1) definition of the construct; (2) design of the scale items, response options and instructions; (3) full administration of the scale, item analysis and dimensionality analysis. The scale was administered to 308 adolescents with juvenile idiopathic arthritis (JIA) and 303 parents/guardians, prior to and 12 months after the implementation of an evaluation of a structured and co-ordinated programme of transitional care. The patient population involved adolescents with JIA and their parents recruited from 10 major UK rheumatology centres. A total of 301 (97.7%) adolescents and 286 (95.0%) parents chose to complete the questionnaire, with median item completion rates of 100.0% (0-100%) for both adolescents and parents thus confirming feasibility. Face and content validity were confirmed. Factor analyses revealed a three-factor structure which explained 49.5% and 56.1% of the variation in adolescent and parent scores respectively. The internal consistency of each subscale ('management of environment', 'provider characteristics' and 'process issues') was indicated by Cronbach's alphas of 0.71, 0.89 and 0.89 for adolescents, respectively, and 0.83, 0.91 and 0.92 for parents respectively. Cronbach's alphas for the entire scales were 0.91 and 0.94 for the adolescent and parent forms respectively. These preliminary results report the potential of the 'Mind the Gap' scale in evaluating transitional care for adolescents with JIA. In view of the generic nature of transitional care reflected in the scale, this scale has wider potential for use with adolescents with other chronic illness in view of the generic nature of transition. This development is particularly timely in the context of transitional care developments in the UK and further validation of the scale is in progress.
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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.
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NASA Astrophysics Data System (ADS)
Cheng, Zihao; Campbell, Robert E.
2007-02-01
Binding proteins suitable for expression and high affinity molecular recognition in the cytoplasm or nucleus of live cells have numerous applications in the biological sciences. In an effort to add a new minimal motif to the growing repertoire of validated non-immunoglobulin binding proteins, we have undertaken the development of a generic protein scaffold based on a single β-hairpin that can fold efficiently in the cytoplasm. We have developed a method, based on the measurement of fluorescence resonance energy transfer (FRET) between a genetically fused cyan fluorescent protein (CFP) and yellow fluorescent protein (YFP), that allows the structural stability of recombinant β-hairpin peptides to be rapidly assessed both in vitro and in vivo. We have previously reported the validation of this method when applied to a 16mer tryptophan zipper β-hairpin. We now describe the use of this method to evaluate the potential of a designed 20mer β-hairpin peptide with a 3rd Trp/Trp cross-strand pair to function as a generic protein scaffold. Quantitative analysis of the FRET efficiency, resistance to proteolysis (assayed by loss of FRET), and circular dichroism spectra revealed that the 20mer peptide is significantly more tolerant of destabilizing mutations than the 16mer peptide. Furthermore, we experimentally demonstrate that the in vitro determined β-hairpin stabilities are well correlated with in vivo β-hairpin stabilities as determined by FRET measurements of colonies of live bacteria expressing the recombinant peptides flanked by CFP and YFP. Finally, we report on our progress to develop highly folded 24mer and 28mer β-hairpin peptides through the use of fluorescence-based library screening.
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Specialty-specific multi-source feedback: assuring validity, informing training.
Davies, Helena; Archer, Julian; Bateman, Adrian; Dewar, Sandra; Crossley, Jim; Grant, Janet; Southgate, Lesley
2008-10-01
The white paper 'Trust, Assurance and Safety: the Regulation of Health Professionals in the 21st Century' proposes a single, generic multi-source feedback (MSF) instrument in the UK. Multi-source feedback was proposed as part of the assessment programme for Year 1 specialty training in histopathology. An existing instrument was modified following blueprinting against the histopathology curriculum to establish content validity. Trainees were also assessed using an objective structured practical examination (OSPE). Factor analysis and correlation between trainees' OSPE performance and the MSF were used to explore validity. All 92 trainees participated and the assessor response rate was 93%. Reliability was acceptable with eight assessors (95% confidence interval 0.38). Factor analysis revealed two factors: 'generic' and 'histopathology'. Pearson correlation of MSF scores with OSPE performances was 0.48 (P = 0.001) and the histopathology factor correlated more highly (histopathology r = 0.54, generic r = 0.42; t = - 2.76, d.f. = 89, P < 0.01). Trainees scored least highly in relation to ability to use histopathology to solve clinical problems (mean = 4.39) and provision of good reports (mean = 4.39). Three of six doctors whose means were < 4.0 received free text comments about report writing. There were 83 forms with aggregate scores of < 4. Of these, 19.2% included comments about report writing. Specialty-specific MSF is feasible and achieves satisfactory reliability. The higher correlation of the 'histopathology' factor with the OSPE supports validity. This paper highlights the importance of validating an MSF instrument within the specialty-specific context as, in addition to assuring content validity, the PATH-SPRAT (Histopathology-Sheffield Peer Review Assessment Tool) also demonstrates the potential to inform training as part of a quality improvement model.
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Protein Solubility and Protein Homeostasis: A Generic View of Protein Misfolding Disorders
Vendruscolo, Michele; Knowles, Tuomas P.J.; Dobson, Christopher M.
2011-01-01
According to the “generic view” of protein aggregation, the ability to self-assemble into stable and highly organized structures such as amyloid fibrils is not an unusual feature exhibited by a small group of peptides and proteins with special sequence or structural properties, but rather a property shared by most proteins. At the same time, through a wide variety of techniques, many of which were originally devised for applications in other disciplines, it has also been established that the maintenance of proteins in a soluble state is a fundamental aspect of protein homeostasis. Taken together, these advances offer a unified framework for understanding the molecular basis of protein aggregation and for the rational development of therapeutic strategies based on the biological and chemical regulation of protein solubility. PMID:21825020
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DABI: A data base for image analysis with nondeterministic inference capability
NASA Technical Reports Server (NTRS)
Yakimovsky, Y.; Cunningham, R.
1976-01-01
A description is given of the data base used in the perception subsystem of the Mars robot vehicle prototype being implemented at the Jet Propulsion Laboratory. This data base contains two types of information. The first is generic (uninstantiated, abstract) information that specifies the general rules of perception of objects in the expected environments. The second kind of information is a specific (instantiated) description of a structure, i.e., the properties and relations of objects in the specific case being analyzed. The generic knowledge can be used by the approximate reasoning subsystem to obtain information on the specific structures which is not directly measurable by the sensory instruments. Raw measurements are input either from the sensory instruments or a human operator using a CRT or a TTY.
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Competitive Strategy in Continuing Education.
ERIC Educational Resources Information Center
Baden, Clifford
1987-01-01
Reviews strategic variables available to those planning continuing education marketing programs. Discusses generic competitive strategies: (1) overall cost leadership, (2) differentiation, and (3) specialization. Mentions several potential problems. (CH)
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Yeung, Nelson C Y; Lau, Joseph T F; Yu, Xiao-nan; Chu, Yvonne; Shing, Matthew M K; Leung, Ting Fan; Li, Chi Kong; Fok, Tai Fai; Mak, Winnie W S
2013-01-01
The Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales are commonly used to assess health-related quality of life of healthy children and pediatric patients. Validation of the Generic Core Scales among Chinese pediatric cancer patients has not been reported in the literature. The scales can serve to measure different quality-of-life domains that are not captured by the PedsQL Cancer Module. Psychometric properties of the Chinese version of the PedsQL 4.0 among pediatric cancer patients and their caretakers were examined. The Generic Core Scales were administered to 335 pairs of pediatric cancer patients (aged 8-18 years) and their caretakers in Hong Kong. A 5-factor structure (physical, emotional, social, school-related cognitive function, and missed school) was identified in the patient and proxy versions of the scales using confirmatory factor analysis. Both versions of the total scale reported Cronbach α's of .90 or greater, with almost all subscales reporting α's of .70 or greater. Test-retest reliability at 2 weeks was acceptable (intraclass correlations ≥0.60) for a majority of subscales. Agreement between patients' and caretakers' ratings was medium. The scales demonstrated acceptable psychometric properties and construct validity. This study validated the Chinese version of the Generic Core Scales among pediatric cancer patients and their caretakers, which supports the future use of the scales in clinical settings. The Generic Core Scales can also be supplementary to the PedsQL Cancer Module for measuring multiple domains of quality of life in cancer population.
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Generic mission planning concepts for space astronomy missions
NASA Technical Reports Server (NTRS)
Guffin, O. T.; Onken, J. F.
1993-01-01
The past two decades have seen the rapid development of space astronomy, both manned and unmanned, and the concurrent proliferation of the operational concepts and software that have been produced to support each individual project. Having been involved in four of these missions since the '70's and three yet to fly in the present decade, the authors believe it is time to step back and evaluate this body of experience from a macro-systems point of view to determine the potential for generic mission planning concepts that could be applied to future missions. This paper presents an organized evaluation of astronomy mission planning functions, functional flows, iteration cycles, replanning activities, and the requirements that drive individual concepts to specific solutions. The conclusions drawn from this exercise are then used to propose a generic concept that could support multiple missions.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Banerjee, Atreyee; Nandi, Manoj Kumar; Bhattacharyya, Sarika Maitra, E-mail: mb.sarika@ncl.res.in
2016-07-21
In this paper, we present a study of supercooled liquids interacting with the Lennard Jones potential and the corresponding purely repulsive (Weeks-Chandler-Andersen) potential, over a range of densities and temperatures, in order to understand the origin of their different dynamics in spite of their structures being similar. Using the configurational entropy as the thermodynamic marker via the Adam Gibbs relation, we show that the difference in the dynamics of these two systems at low temperatures can be explained from thermodynamics. At higher densities both the thermodynamical and dynamical difference between these model systems decrease, which is quantitatively demonstrated in thismore » paper by calculating different parameters. The study also reveals the origin of the difference in pair entropy despite the similarity in the structure. Although the maximum difference in structure is obtained in the partial radial distribution function of the B type of particles, the rdf of AA pairs and AB pairs gives rise to the differences in the entropy and dynamics. This work supports the observation made in an earlier study [A. Banerjee et al., Phys. Rev. Lett. 113, 225701 (2014)] and shows that they are generic in nature, independent of density.« less
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NASA Astrophysics Data System (ADS)
Przybylska, M.
2009-06-01
In this paper the problem of classification of integrable natural Hamiltonian systems with n degrees of freedom given by a Hamilton function, which is the sum of the standard kinetic energy and a homogeneous polynomial potential V of degree k > 2, is investigated. It is assumed that the potential is not generic. Except for some particular cases a potential V is not generic if it admits a nonzero solution of equation V'( d) = 0. The existence of such a solution gives very strong integrability obstructions obtained in the frame of the Morales-Ramis theory. This theory also gives additional integrability obstructions which have the form of restrictions imposed on the eigenvalues ( λ 1, …, λ n ) of the Hessian matrix V″( d) calculated at a nonzero d ∈ ℂ n satisfying V'( d) = d. In our previous work we showed that for generic potentials some universal relations between ( λ 1, …, λ n ) calculated at various solutions of V' ( d) = d exist. These relations allow one to prove that the number of potentials satisfying the necessary conditions for the integrability is finite. The main aim of this paper was to show that relations of such forms also exist for nongeneric potentials. We show their existence and derive them for the case n = k = 3 applying the multivariable residue calculus. We demonstrate the strength of the results analyzing in details the nongeneric cases for n = k = 3. Our analysis covers all the possibilities and we distinguish those cases where known methods are too weak to decide if the potential is integrable or not. Moreover, for n = k = 3, thanks to this analysis, a three-parameter family of potentials integrable or superintegrable with additional polynomial first integrals which seemingly can be of an arbitrarily high degree with respect to the momenta was distinguished.
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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
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Generic Wing-Body Aerodynamics Data Base
NASA Technical Reports Server (NTRS)
Holst, Terry L.; Olsen, Thomas H.; Kwak, Dochan (Technical Monitor)
2001-01-01
The wing-body aerodynamics data base consists of a series of CFD (Computational Fluid Dynamics) simulations about a generic wing body configuration consisting of a ogive-circular-cylinder fuselage and a simple symmetric wing mid-mounted on the fuselage. Solutions have been obtained for Nonlinear Potential (P), Euler (E) and Navier-Stokes (N) solvers over a range of subsonic and transonic Mach numbers and angles of attack. In addition, each solution has been computed on a series of grids, coarse, medium and fine to permit an assessment of grid refinement errors.
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Energy use in the marine transportation industry. Task II. Efficiency improvements. Draft report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1977-06-02
Research and development areas that hold promise for maritime energy conservation are identified and evaluated. The methodology used in the evaluation of potential research areas and results, conclusions, and recommendations are presented. Fifteen programs are identified in four generic technologies and these are discussed in detail in appendices A-D. The areas are: main propulsion plants, propulsors, hydrodynamics, and vessel operations. Fuels are discussed briefly in appendix E. Additional information is presented on the generic US flag baseline operational and cost parameters; a sample output model is presented. (MCW)
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Cheng, Yuanyuan; Nathanail, Paul C
2009-12-20
Generic Assessment Criteria (GAC) are derived using widely applicable assumptions about the characteristics and behaviour of contaminant sources, pathways and receptors. GAC provide nationally consistent guidance, thereby saving money and time. Currently, there are no human health based Generic Assessment Criteria (GAC) for contaminated sites in China. Protection of human health is therefore difficult to ensure and demonstrate; and the lack of GAC makes it difficult to tell if there is potential significant risk to human health unless site-specific criteria are derived. This paper derived Chinese GAC (GAC) for five inorganic and eight organic substances for three regions in China for three land uses: urban residential without plant uptake, Chinese cultivated land, and commercial/industrial using the SNIFFER model. The SNIFFER model has been further implemented with a dermal absorption algorithm and the model default input values have been changed to reflect the Chinese exposure scenarios. It is envisaged that the modified SNIFFER model could be used to derive GAC for more contaminants, more Regions, and more land uses. Further research to enhance the reliability and acceptability of the GAC is needed in regional/national surveys in diet and working patterns.
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NASA Astrophysics Data System (ADS)
Zhang, X. F.; Hu, S. D.; Tzou, H. S.
2014-12-01
Converting vibration energy to useful electric energy has attracted much attention in recent years. Based on the electromechanical coupling of piezoelectricity, distributed piezoelectric zero-curvature type (e.g., beams and plates) energy harvesters have been proposed and evaluated. The objective of this study is to develop a generic linear and nonlinear piezoelectric shell energy harvesting theory based on a double-curvature shell. The generic piezoelectric shell energy harvester consists of an elastic double-curvature shell and piezoelectric patches laminated on its surface(s). With a current model in the closed-circuit condition, output voltages and energies across a resistive load are evaluated when the shell is subjected to harmonic excitations. Steady-state voltage and power outputs across the resistive load are calculated at resonance for each shell mode. The piezoelectric shell energy harvesting mechanism can be simplified to shell (e.g., cylindrical, conical, spherical, paraboloidal, etc.) and non-shell (beam, plate, ring, arch, etc.) distributed harvesters using two Lamé parameters and two curvature radii of the selected harvester geometry. To demonstrate the utility and simplification procedures, the generic linear/nonlinear shell energy harvester mechanism is simplified to three specific structures, i.e., a cantilever beam case, a circular ring case and a conical shell case. Results show the versatility of the generic linear/nonlinear shell energy harvesting mechanism and the validity of the simplification procedures.
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Ageing management of french NPP civil work structures
NASA Astrophysics Data System (ADS)
Gallitre, E.; Dauffer, D.
2011-04-01
This paper presents EDF practice about concrete structure ageing management, from the mechanisms analysis to the formal procedure which allows the French company to increase 900 MWe NPP lifetime until 40 years; it will also introduce its action plan for 60 years lifetime extension. This practice is based on a methodology which identifies every ageing mechanism; both plants feedback and state of the art are screened and conclusions are drawn up into an "ageing analysis data sheet". That leads at first to a collection of 57 data sheets which give the mechanism identification, the components that are concerned and an analysis grid which is designed to assess the safety risk. This analysis screens the reference documents describing the mechanism, the design lifetime hypotheses, the associated regulation or codification, the feedback experiences, the accessibility, the maintenance actions, the repair possibility and so one. This analysis has to lead to a conclusion about the risk taking into account monitoring and maintenance. If the data sheet conclusion is not clear enough, then a more detailed report is launched. The technical document which is needed, is a formal detailed report which summarizes every theoretical knowledge and monitoring data: its objective is to propose a solution for ageing management: this solution can include more inspections or specific research development, or additional maintenance. After a first stage on the 900 MWe units, only two generic ageing management detailed reports have been needed for the civil engineering part: one about reactor building containment, and one about other structures which focuses on concrete inflating reactions. The second stage consists on deriving this generic analysis (ageing mechanism and detailed reports) to every plant where a complete ageing report is required (one report for all equipments and structures of the plant, but specific for each reactor). This ageing management is a continuous process because the 57 generic data sheets set is updated every year and the detailed generic reports every five years. After this 40 year lifetime extension, EDF is preparing a 60 years lifetime action plan which includes R&D actions, specific industrial studies and also monitoring improvements.
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NASA Astrophysics Data System (ADS)
Yoo, S.; Zeng, X. C.
2006-05-01
We performed a constrained search for the geometries of low-lying neutral germanium clusters GeN in the size range of 21⩽N⩽29. The basin-hopping global optimization method is employed for the search. The potential-energy surface is computed based on the plane-wave pseudopotential density functional theory. A new series of low-lying clusters is found on the basis of several generic structural motifs identified previously for silicon clusters [S. Yoo and X. C. Zeng, J. Chem. Phys. 124, 054304 (2006)] as well as for smaller-sized germanium clusters [S. Bulusu et al., J. Chem. Phys. 122, 164305 (2005)]. Among the generic motifs examined, we found that two motifs stand out in producing most low-lying clusters, namely, the six/nine motif, a puckered-hexagonal-ring Ge6 unit attached to a tricapped trigonal prism Ge9, and the six/ten motif, a puckered-hexagonal-ring Ge6 unit attached to a bicapped antiprism Ge10. The low-lying clusters obtained are all prolate in shape and their energies are appreciably lower than the near-spherical low-energy clusters. This result is consistent with the ion-mobility measurement in that medium-sized germanium clusters detected are all prolate in shape until the size N ˜65.
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The complex folding pathways of protein A suggest a multiple-funnelled energy landscape
NASA Astrophysics Data System (ADS)
St-Pierre, Jean-Francois; Mousseau, Normand; Derreumaux, Philippe
2008-01-01
Folding proteins into their native states requires the formation of both secondary and tertiary structures. Many questions remain, however, as to whether these form into a precise order, and various pictures have been proposed that place the emphasis on the first or the second level of structure in describing folding. One of the favorite test models for studying this question is the B domain of protein A, which has been characterized by numerous experiments and simulations. Using the activation-relaxation technique coupled with a generic energy model (optimized potential for efficient peptide structure prediction), we generate more than 50 folding trajectories for this 60-residue protein. While the folding pathways to the native state are fully consistent with the funnel-like description of the free energy landscape, we find a wide range of mechanisms in which secondary and tertiary structures form in various orders. Our nonbiased simulations also reveal the presence of a significant number of non-native β and α conformations both on and off pathway, including the visit, for a non-negligible fraction of trajectories, of fully ordered structures resembling the native state of nonhomologous proteins.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Oegetbil, O.
After reviewing the existing results we give an extensive analysis of the critical points of the potentials of the gauged N=2 Yang-Mills/Einstein supergravity theories coupled to tensor multiplets and hypermultiplets. Our analysis includes all the possible gaugings of all N=2 Maxwell-Einstein supergravity theories whose scalar manifolds are symmetric spaces. In general, the scalar potential gets contributions from R-symmetry gauging, tensor couplings, and hypercouplings. We show that the coupling of a hypermultiplet into a theory whose potential has a nonzero value at its critical point, and gauging a compact subgroup of the hyperscalar isometry group will only rescale the value ofmore » the potential at the critical point by a positive factor, and therefore will not change the nature of an existing critical point. However this is not the case for noncompact SO(1,1) gaugings. An SO(1,1) gauging of the hyperisometry will generally lead to de Sitter vacua, which is analogous to the ground states found by simultaneously gauging SO(1,1) symmetry of the real scalar manifold with U(1){sub R} in earlier literature. SO(m,1) gaugings with m>1, which give contributions to the scalar potential only in the magical Jordan family theories, on the other hand, do not lead to de Sitter vacua. Anti-de Sitter vacua are generically obtained when the U(1){sub R} symmetry is gauged. We also show that it is possible to embed certain generic Jordan family theories into the magical Jordan family preserving the nature of the ground states. However the magical Jordan family theories have additional ground states which are not found in the generic Jordan family theories.« less
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Ciardo, Delia; Gerardi, Marianna Alessandra; Vigorito, Sabrina; Morra, Anna; Dell'acqua, Veronica; Diaz, Federico Javier; Cattani, Federica; Zaffino, Paolo; Ricotti, Rosalinda; Spadea, Maria Francesca; Riboldi, Marco; Orecchia, Roberto; Baroni, Guido; Leonardi, Maria Cristina; Jereczek-Fossa, Barbara Alicja
2017-04-01
Atlas-based automatic segmentation (ABAS) addresses the challenges of accuracy and reliability in manual segmentation. We aim to evaluate the contribution of specific-purpose in ABAS of breast cancer (BC) patients with respect to generic-purpose libraries. One generic-purpose and 9 specific-purpose libraries, stratified according to type of surgery and size of thorax circumference, were obtained from the computed tomography of 200 BC patients. Keywords about contralateral breast volume and presence of breast expander/prostheses were recorded. ABAS was validated on 47 independent patients, considering manual segmentation from scratch as reference. Five ABAS datasets were obtained, testing single-ABAS and multi-ABAS with simultaneous truth and performance level estimation (STAPLE). Center of mass distance (CMD), average Hausdorff distance (AHD) and Dice similarity coefficient (DSC) between corresponding ABAS and manual structures were evaluated and statistically significant differences between different surgeries, structures and ABAS strategies were investigated. Statistically significant differences between patients who underwent different surgery were found, with superior results for conservative-surgery group, and between different structures were observed: ABAS of heart, lungs, kidneys and liver was satisfactory (median values: CMD<2 mm, DSC≥0.80, AHD<1.5 mm), whereas chest wall, breast and spinal cord obtained moderate performance (median values: 2 mm ≤ CMD<5 mm, 0.60 ≤ DSC<0.80, 1.5 mm ≤ AHD<4 mm) and esophagus, stomach, brachial plexus and supraclavicular nodes obtained poor performance (median CMD≥5 mm, DSC<0.60, AHD≥4 mm). The application of STAPLE algorithm generally yields higher performance and the use of keywords improves results for breast ABAS. The homogeneity in the selection of atlases based on multiple anatomical and clinical features and the use of specific-purpose libraries can improve ABAS performance with respect to generic-purpose libraries. Copyright © 2016 Elsevier Ltd. All rights reserved.
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How language shapes the cultural inheritance of categories
Gelman, Susan A.; Roberts, Steven O.
2017-01-01
It is widely recognized that language plays a key role in the transmission of human culture, but relatively little is known about the mechanisms by which language simultaneously encourages both cultural stability and cultural innovation. This paper examines this issue by focusing on the use of language to transmit categories, focusing on two universal devices: labels (e.g., shark, woman) and generics (e.g., “sharks attack swimmers”; “women are nurturing”). We propose that labels and generics each assume two key principles: norms and essentialism. The normative assumption permits transmission of category information with great fidelity, whereas essentialism invites innovation by means of an open-ended, placeholder structure. Additionally, we sketch out how labels and generics aid in conceptual alignment and the progressive “looping” between categories and cultural practices. In this way, human language is a technology that enhances and expands the categorization capacities that we share with other animals. PMID:28739931
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Multiferroicity in the generic easy-plane triangular lattice antiferromagnet RbFe(MoO4)2
NASA Astrophysics Data System (ADS)
White, J. S.; Niedermayer, Ch.; Gasparovic, G.; Broholm, C.; Park, J. M. S.; Shapiro, A. Ya.; Demianets, L. A.; Kenzelmann, M.
2013-08-01
RbFe(MoO4)2 is a quasi-two-dimensional (quasi-2D) triangular lattice antiferromagnet (TLA) that displays a zero-field magnetically driven multiferroic phase with a chiral spin structure. By inelastic neutron scattering, we determine quantitatively the spin Hamiltonian. We show that the easy-plane anisotropy is nearly 1/3 of the dominant spin exchange, making RbFe(MoO4)2 an excellent system for studying the physics of the model 2D easy-plane TLA. Our measurements demonstrate magnetic-field-induced fluctuations in this material to stabilize the generic finite-field phases of the 2D XY TLA. We further explain how Dzyaloshinskii-Moriya interactions can generate ferroelectricity only in the zero-field phase. Our conclusion is that multiferroicity in RbFe(MoO4)2, and its absence at high fields, results from the generic properties of the 2D XY TLA.
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Composite structural materials
NASA Technical Reports Server (NTRS)
Ansell, G. S.; Loewy, R. G.; Wiberley, S. E.
1982-01-01
Research in the basic composition, characteristics, and processng science of composite materials and their constituents is balanced against the mechanics, conceptual design, fabrication, and testing of generic structural elements typical of aerospace vehicles so as to encourage the discovery of unusual solutions to problems. Detailed descriptions of the progress achieved in the various component parts of his program are presented.
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The Semiotic Structure of Geometry Diagrams: How Textbook Diagrams Convey Meaning
ERIC Educational Resources Information Center
Dimmel, Justin K.; Herbst, Patricio G.
2015-01-01
Geometry diagrams use the visual features of specific drawn objects to convey meaning about generic mathematical entities. We examine the semiotic structure of these visual features in two parts. One, we conduct a semiotic inquiry to conceptualize geometry diagrams as mathematical texts that comprise choices from different semiotic systems. Two,…
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The Structure of PhD Conclusion Chapters
ERIC Educational Resources Information Center
Bunton, David
2005-01-01
This paper considers the generic structure of "Conclusion" chapters in PhD theses or dissertations. From a corpus of 45 PhD theses covering a range of disciplines, chapters playing a concluding role were identified and analysed for their functional moves and steps. Most "Conclusions" were found to restate purpose, consolidate research space with a…
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Structural Patterns in Empirical Research Articles: A Cross-Disciplinary Study
ERIC Educational Resources Information Center
Lin, Ling; Evans, Stephen
2012-01-01
This paper presents an analysis of the major generic structures of empirical research articles (RAs), with a particular focus on disciplinary variation and the relationship between the adjacent sections in the introductory and concluding parts. The findings were derived from a close "manual" analysis of 433 recent empirical RAs from high-impact…
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Effect of stress concentrations in composite structures
NASA Technical Reports Server (NTRS)
Babcock, G. D.; Knauss, W. G.
1984-01-01
The goal of achieving a better understanding of the failure of complex composite structure is sought. This type of structure requires a thorough understanding of the behavior under load both on a macro and micro scale if failure mechanisms are to be understood. The two problems being studied are the failure at a panel/stiffener interface and a generic problem of failure at a stress concentration.
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NASA Technical Reports Server (NTRS)
Mineck, Raymond E.
1999-01-01
An unstructured-grid Navier-Stokes solver was used to predict the surface pressure distribution, the off-body flow field, the surface flow pattern, and integrated lift and drag coefficients on the ROBIN configuration (a generic helicopter) without a rotor at four angles of attack. The results are compared to those predicted by two structured- grid Navier-Stokes solvers and to experimental surface pressure distributions. The surface pressure distributions from the unstructured-grid Navier-Stokes solver are in good agreement with the results from the structured-grid Navier-Stokes solvers. Agreement with the experimental pressure coefficients is good over the forward portion of the body. However, agreement is poor on the lower portion of the mid-section of the body. Comparison of the predicted surface flow patterns showed similar regions of separated flow. Predicted lift and drag coefficients were in fair agreement with each other.
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Origin of chaos near three-dimensional quantum vortices: A general Bohmian theory
NASA Astrophysics Data System (ADS)
Tzemos, Athanasios C.; Efthymiopoulos, Christos; Contopoulos, George
2018-04-01
We provide a general theory for the structure of the quantum flow near three-dimensional (3D) nodal lines, i.e., one-dimensional loci where the 3D wave function becomes equal to zero. In suitably defined coordinates (comoving with the nodal line) the generic structure of the flow implies the formation of 3D quantum vortices. We show that such vortices are accompanied by nearby invariant lines of the comoving quantum flow, called X lines, which are normally hyperbolic. Furthermore, the stable and unstable manifolds of the X lines produce chaotic scatterings of nearby quantum (Bohmian) trajectories, thus inducing an intricate form of the quantum current in the neighborhood of each 3D quantum vortex. Generic formulas describing the structure around 3D quantum vortices are provided, applicable to an arbitrary choice of 3D wave function. We also give specific numerical examples as well as a discussion of the physical consequences of chaos near 3D quantum vortices.
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Origin of chaos near three-dimensional quantum vortices: A general Bohmian theory.
Tzemos, Athanasios C; Efthymiopoulos, Christos; Contopoulos, George
2018-04-01
We provide a general theory for the structure of the quantum flow near three-dimensional (3D) nodal lines, i.e., one-dimensional loci where the 3D wave function becomes equal to zero. In suitably defined coordinates (comoving with the nodal line) the generic structure of the flow implies the formation of 3D quantum vortices. We show that such vortices are accompanied by nearby invariant lines of the comoving quantum flow, called X lines, which are normally hyperbolic. Furthermore, the stable and unstable manifolds of the X lines produce chaotic scatterings of nearby quantum (Bohmian) trajectories, thus inducing an intricate form of the quantum current in the neighborhood of each 3D quantum vortex. Generic formulas describing the structure around 3D quantum vortices are provided, applicable to an arbitrary choice of 3D wave function. We also give specific numerical examples as well as a discussion of the physical consequences of chaos near 3D quantum vortices.
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Entanglement on linked boundaries in Chern-Simons theory with generic gauge groups
NASA Astrophysics Data System (ADS)
Dwivedi, Siddharth; Singh, Vivek Kumar; Dhara, Saswati; Ramadevi, P.; Zhou, Yang; Joshi, Lata Kh
2018-02-01
We study the entanglement for a state on linked torus boundaries in 3 d Chern-Simons theory with a generic gauge group and present the asymptotic bounds of Rényi entropy at two different limits: (i) large Chern-Simons coupling k, and (ii) large rank r of the gauge group. These results show that the Rényi entropies cannot diverge faster than ln k and ln r, respectively. We focus on torus links T (2 , 2 n) with topological linking number n. The Rényi entropy for these links shows a periodic structure in n and vanishes whenever n = 0 (mod p), where the integer p is a function of coupling k and rank r. We highlight that the refined Chern-Simons link invariants can remove such a periodic structure in n.
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Composite Load Spectra for Select Space Propulsion Structural Components
NASA Technical Reports Server (NTRS)
Ho, Hing W.; Newell, James F.
1994-01-01
Generic load models are described with multiple levels of progressive sophistication to simulate the composite (combined) load spectra (CLS) that are induced in space propulsion system components, representative of Space Shuttle Main Engines (SSME), such as transfer ducts, turbine blades and liquid oxygen (LOX) posts. These generic (coupled) models combine the deterministic models for composite load dynamic, acoustic, high-pressure and high rotational speed, etc., load simulation using statistically varying coefficients. These coefficients are then determined using advanced probabilistic simulation methods with and without strategically selected experimental data. The entire simulation process is included in a CLS computer code. Applications of the computer code to various components in conjunction with the PSAM (Probabilistic Structural Analysis Method) to perform probabilistic load evaluation and life prediction evaluations are also described to illustrate the effectiveness of the coupled model approach.
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Woods-Giscombé, Cheryl L.; Lobel, Marci
2008-01-01
Based on prior research and theory, the authors constructed a multidimensional model of stress in African American women comprised of race-related, gender-related, and generic stress. Exposure to and appraisal of these three types of stress were combined into a higher-order global stress factor. Using structural equation modeling, the fit of this stress factor and its ability to predict distress symptoms were examined in 189 socioeconomically diverse African American women aged 21 to 78. Results support the multidimensional conceptualization and operationalization of stress. Race-related, gender-related, and generic stress contributed equally to the global stress factor, and global stress predicted a significant amount of variance in distress symptoms and intensity. This model exhibited better fit than a model without a global stress factor, in which each stress component predicted distress directly. Furthermore, race-related, gender-related, and generic stress did not contribute to distress beyond their representation in the global stress factor. These findings illustrate that stress related to central elements of identity, namely race and gender, cohere with generic stress to define the stress experience of African American women. PMID:18624581
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Woods-Giscombé, Cheryl L; Lobel, Marci
2008-07-01
Based on prior research and theory, the authors constructed a multidimensional model of stress in African American women comprised of race-related, gender-related, and generic stress. Exposure to and appraisal of these three types of stress were combined into a higher-order global stress factor. Using structural equation modeling, the fit of this stress factor and its ability to predict distress symptoms were examined in 189 socioeconomically diverse African American women aged 21 to 78. Results support the multidimensional conceptualization and operationalization of stress. Race-related, gender-related, and generic stress contributed equally to the global stress factor, and global stress predicted a significant amount of variance in distress symptoms and intensity. This model exhibited better fit than a model without a global stress factor, in which each stress component predicted distress directly. Furthermore, race-related, gender-related, and generic stress did not contribute to distress beyond their representation in the global stress factor. These findings illustrate that stress related to central elements of identity, namely race and gender, cohere with generic stress to define the stress experience of African American women. Copyright (c) 2008 APA, all rights reserved.
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Buckling Behavior of Long Anisotropic Plates Subjected to Fully Restrained Thermal Expansion
NASA Technical Reports Server (NTRS)
Nemeth, Michael P.
2001-01-01
An approach for synthesizing buckling results and behavior for thin balanced and unbalanced symmetric laminates that are subjected to uniform heating or cooling and fully restrained against thermal expansion or contraction is presented. This approach uses a nondimensional analysis for infinitely long, flexurally anisotropic plates that are subjected to combined mechanical loads and is based on useful nondimensional parameters. In addition, stiffness-weighted laminate thermal-expansion parameters are derived that are used to determine critical temperatures in terms of physically intuitive mechanical buckling coefficients, and the effects of membrane orthotropy and membrane anisotropy are included. Many results are presented for some common laminates that are intended to facilitate a structural designer's transition to the use of the generic buckling design curves that are presented in the paper. Several generic buckling design curves are presented that provide physical insight into the buckling response in addition to providing useful design data. Examples are presented that demonstrate the use of the generic design curves. The analysis approach and generic results indicate the effects and characteristics of laminate thermal expansion, membrane orthotropy and anisotropy, and flexural orthotropy and anisotropy in a very general and unifying manner.
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Ramiro, Miguel A; Llibre, Josep M
2014-11-01
The availability of generic lamivudine in the context of the current economic crisis has raised a new issue in some European countries: breaking up the once-daily fixed-dose antiretroviral combinations (FDAC) of efavirenz/tenofovir/emtricitabine, tenofovir/emtricitabine, or abacavir/lamivudine, in order to administer their components separately, thereby allowing the use of generic lamivudine instead of branded emtricitabine or lamivudine. The legal, ethical, and economic implications of this potential strategy are reviewed, particularly in those patients receiving a once-daily single-tablet regimen. An unfamiliar change in antiretroviral treatment from a successful patient-friendly FDAC into a more complex regimen including separately the components to allow the substitution of one (or some) of them for generic surrogates (in the absence of a generic bioequivalent FDAC) could be discriminatory because it does not guarantee access to equal excellence in healthcare to all citizens. Furthermore, it could violate the principle of non-maleficence by potentially causing harm both at the individual level (hindering adherence and favouring treatment failure and resistance), and at the community level (hampering control of disease transmission and transmission of HIV-1 resistance). Replacing a FDAC with the individual components of that combination should only be permitted when the substituting medication has the same qualitative and quantitative composition of active ingredients, pharmaceutical form, method of administration, dosage and presentation as the medication being replaced, and a randomized study has demonstrated its non-inferiority. Finally, a strict pharma-economic study supporting this change, comparing the effectiveness and the cost of a specific intervention with the best available alternative, should be undertaken before its potential implementation. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.
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FOSSIL2 energy policy model documentation: generic structures of the FOSSIL2 model
DOE Office of Scientific and Technical Information (OSTI.GOV)
None
1980-10-01
This report discusses the structure, derivations, assumptions, and mathematical formulation of the FOSSIL2 model. Each major facet of the model - supply/demand interactions, industry financing, and production - has been designed to parallel closely the actual cause/effect relationships determining the behavior of the United States energy system. The data base for the FOSSIL2 program is large. When possible, all data were obtained from sources well known to experts in the energy field. Cost and resource estimates are based on DOE data whenever possible. This report presents the FOSSIL2 model at several levels. In Volume I, an overview of the basicmore » structures, assumptions, and behavior of the FOSSIL2 model is presented so that the reader can understand the results of various policy tests. The discussion covers the three major building blocks, or generic structures, used to construct the model: supply/demand balance; finance and capital formation; and energy production. These structures reflect the components and interactions of the major processes within each energy industry that directly affect the dynamics of fuel supply, demand, and price within the energy system as a whole.« less
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A vision of the pharmaceutical industry.
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.
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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.
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Anderson, Bruce; Ke, Xuehua; Klein-Schwartz, Wendy
2010-08-01
In 2006, the annual report of poison centers in the United States changed the method of reporting profiles for generic substance categories from all exposures to single-substance exposures only. The objective of this study is to describe the potential impact of this reporting change on longitudinal analysis of outcomes. Generic substance categories with data available for all years of the study were manually extracted from Table 22 of the National Poison Data System (NPDS) annual reports for 2002-2007. For each generic substance category, the following data were extracted for each of the 6 years: total number of substance mentions (2002-2005) or single-substance exposures (2006-2007), reason (unintentional or intentional), pediatric exposures (children age <6 years), and outcomes of major effect and death. Data were compared using descriptive analysis (Wilcoxon signed-rank test) and negative binomial regression. There were 65 generic substance categories (30 drug categories and 35 nondrug categories) that had data in all study years. For drug categories the average annual number of reported deaths by substance category decreased by 80.8%, from 2,229 in year 2002-2005 to 428 after the 2006 reporting change (p < 0.0001). The average annual number of reported major outcomes by substance category dropped by 76.0% (p < 0.0001). The impact on nondrug categories was similar: the annual average number of deaths and major effects by substance category decreased by about 50% from 394 and 4,639 per year during 2002-2005 to 198 deaths (p < 0.0001) and 2,357 major effects (p ≤ 0.0001) during 2006-2007. After controlling for potential covariates, multivariate regression showed that there were significant decreases in average rates of reported deaths (61.7 and 35.9%) and major effects (36.3 and 11.2%) for drug categories and nondrug categories, respectively (p < 0.01 for all). Overall rates of major outcomes and deaths reported to poison control centers from 2002 to 2007 have remained constant. The new method of describing demographic data in Table 22 results in outcomes that are different from those reported in previous NPDS annual reports. Comparing NPDS generic substance outcome data before and after the reporting change in 2006 will yield inaccurate results if the change in reporting methodology is not taken into account.
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[Users sceptical about generic drugs: an anthropological approach].
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.
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Cost-effectiveness analysis of valsartan versus losartan and the effect of switching.
Baker, Timothy M; Goh, Jowern; Johnston, Atholl; Falvey, Heather; Brede, Yvonne; Brown, Ruth E
2012-01-01
Losartan will shortly become generic, and this may encourage switching to the generic drug. However, valsartan was shown in a meta-analysis to be statistically superior in lowering blood pressure (BP) to losartan. This paper examines the costs of treatment with these two drugs and the potential consequences of switching established valsartan patients to generic losartan. A US payer cost-effectiveness model was developed incorporating the risk of cardiovascular disease (CVD) events related to systolic blood pressure (SBP) control comparing valsartan to continual losartan and switching from valsartan to generic losartan. The model, based upon a meta-analysis by Nixon et al. and Framingham equations, included first CVD event costs calculated from US administrative data sets and utility values from published sources. The modeled outcomes were number of CVD events, costs and incremental cost per quality-adjusted life-year (QALY) and life-year (LY). Fewer patients had fatal and non-fatal CVD events with valsartan therapy compared with continual losartan and with patients switched from valsartan to generic losartan. The base-case model results indicated that continued treatment with valsartan had an incremental cost-effectiveness ratio of $27,268 and $25,460 per life year gained, and $32,313 and $30,170 per QALY gained, relative to continual losartan and switching treatments, respectively. Sensitivity analyses found that patient discontinuation post-switching was a sensitive parameter. Including efficacy offsets with lowered adherence or discontinuation resulted in more favorable ratios for valsartan compared to switching therapy. The model does not evaluate post-primary CVD events and considers change in SBP from baseline level as the sole predictor of CVD risk. Valsartan appears to be cost-effective compared to switching to generic losartan and switching to the generic drug does not support a cost offset argument over the longer term. Physicians should continue to consider the needs of individual patient and not cost offsets.
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van der Meersch, Amélie; Dechartres, Agnès; Ravaud, Philippe
2011-01-01
Background Generic drugs are used by millions of patients for economic reasons, so their evaluation must be highly transparent. Objective To assess the quality of reporting of bioequivalence trials comparing generic to brand-name drugs. Methodology/Principal Findings PubMed was searched for reports of bioequivalence trials comparing generic to brand-name drugs between January 2005 and December 2008. Articles were included if the aim of the study was to assess the bioequivalency of generic and brand-name drugs. We excluded case studies, pharmaco-economic evaluations, and validation dosage assays of drugs. We evaluated whether important information about funding, methodology, location of trials, and participants were reported. We also assessed whether the criteria required by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) to conclude bioequivalence were reported and that the conclusions were in agreement with the results. We identified 134 potentially relevant articles but eliminated 55 because the brand-name or generic drug status of the reference drug was unknown. Thus, we evaluated 79 articles. The funding source and location of the trial were reported in 41% and 56% of articles, respectively. The type of statistical analysis was reported in 94% of articles, but the methods to generate the randomization sequence and to conceal allocation were reported in only 15% and 5%, respectively. In total, 65 articles of single-dose trials (89%) concluded bioequivalence. Of these, 20 (31%) did not report the 3 criteria within the limits required by the FDA and 11 (17%) did not report the 2 criteria within the limits required by the EMA. Conclusions/Significance Important information to judge the validity and relevance of results are frequently missing in published reports of trials assessing generic drugs. The quality of reporting of such trials is in need of improvement. PMID:21858184
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Consumer choice between common generic and brand medicines in a country with a small generic market.
Fraeyman, Jessica; Peeters, Lies; Van Hal, Guido; Beutels, Philippe; De Meyer, Guido R Y; De Loof, Hans
2015-04-01
Generic medicines offer an opportunity for governments to contain pharmaceutical expenditures, since generics are generally 10%-80% lower in price than brand medicines. Belgium has a small generic market that takes up 15% of the total pharmaceutical market in packages sold. To determine the knowledge of consumers about the different available packages of a common over-the-counter medicine (acetaminophen) with regard to price advantage, quality, and effectiveness in a country with a small generic market. We conducted an online survey in the general Flemish population using a questionnaire with 25 statements. The questionnaire also contained 2 informative interventions. First, we showed the price per package and per tablet that the patient would pay in the pharmacy. Second, we provided the respondent with general information about generic medication (equivalence, effectiveness, price, and recognition). Before and after the interventions, we probed for preferences and knowledge about the different packages. Multivariate logistic models were used to examine the independent effects of consumer characteristics on responses to the survey statements. We obtained a sample of 1,636 respondents. The general attitude towards generic medication was positive-only 5% would rather not use a generic. Nevertheless, only 17% of the respondents were able to recognize a generic medicine. Older consumers (aged 60 years and above) were more often confused about the different packages (OR = 2.59, 95% CI = 1.76-3.80, P ≤ 0.001). Consumers without a higher education degree tended to be more doubtful about the difference in effectiveness and quality between the different brands (OR = 0.59, 95% CI = 0.44-0.79, P ≤ 0.001). Consumer recognition of the name of the active substance of acetaminophen was poor. When different brands were displayed, possible price advantage seemed to be an important motive to switch to a cheaper brand. Consumers generally found medicines to be too expensive; however, consumers with medical or paramedical training had a different opinion. Two main recommendations can be made to increase the knowledge and enhance the trust in cheaper equivalent medicines. First, highlighting the name of the active substance on the label of medicine packages can reduce confusion and avoid health risks, especially among older consumers. Second, new investments or reallocation of budgets should be considered in order to provide consumers with authoritative information on the bioequivalence and price differences between the different available brands. This would be a cost-effective and potentially cost-saving investment for health care payers.
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Roebuck, M Christopher; Liberman, Joshua N
2009-06-01
To study the impact of various elements of pharmacy benefit design on both the absolute and relative utilization of generics, brands, retail pharmacy, and mail service. Panel data on 1,074 plan sponsors covering 21.6 million individuals over 12 calendar quarters (2005-2007). A retrospective analysis of pharmacy claims. To control for potential endogeneity, linear fixed effects models were estimated for each of six dependent variables: the generic utilization rate, the brand utilization rate, the generic dispensing rate (GDR), the retail pharmacy utilization rate, the mail service utilization rate, and the mail distribution rate. Most member cost-share variables were nonlinearly associated with changes in prescription drug utilization. Marginal effects were generally greater in magnitude for brand out-of-pocket costs than for generic out-of-pocket costs. Time dummies, as well as other pharmacy benefit design elements, also yielded significant results. Prior estimates of the effect of member cost sharing on prescription drug utilization may be biased if complex benefit designs, mail service fulfillment, and unmeasured factors such as pharmaceutical pipelines are not accounted for. Commonly cited relative utilization metrics, such as GDR, may be misleading if not examined alongside absolute prescription drug utilization.
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Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets.
Vaithianathan, Soundarya; Raman, Siddarth; Jiang, Wenlei; Ting, Tricia Y; Kane, Maureen A; Polli, James E
2015-07-06
The therapeutic equivalence of generic and brand name antiepileptic drugs has been questioned by neurologists and the epilepsy community. A potential contributor to such concerns is pharmaceutical quality. The objective was to assess the biopharmaceutic risk of brand name Lamictal 100 mg tablets and generic lamotrigine 100 mg tablets from several manufacturers. Lamotrigine was characterized in terms of the Biopharmaceutics Classification System (BCS), including aqueous solubility and Caco-2 permeability. A panel of pharmaceutical quality tests was also performed on three batches of Lamictal, three batches of Teva generic, and one batch of each of four other generics: appearance, identity, assay, impurity, uniformity of dosage units, disintegration, dissolution, friability, and loss on drying. These market surveillance results indicate that all brand name and generic lamotrigine 100 mg tablets passed all tests and showed acceptable pharmaceutical quality and low biopharmaceutic risk. Lamotrigine was classified as a BCS class IIb drug, exhibiting pH-dependent aqueous solubility and dissolution. At pH 1.2 and 4.5, lamotrigine exhibited high solubility, whereas lamotrigine exhibited low solubility at pH 6.8, including non-sink dissolution. Lamotrigine showed high Caco-2 permeability. The apparent permeability (Papp) of lamotrigine was (73.7 ± 8.7) × 10(-6) cm/s in the apical-to-basolateral (AP-BL) direction and (41.4 ± 1.6) × 10(-6) cm/s in the BL-AP direction, which were higher than metoprolol's AP-BL Papp of (21.2 ± 0.9) × 10(-6) cm/s and BL-AP Papp of (34.6 ± 4.6) × 10(-6) cm/s. Overall, lamotrigine's favorable biopharmaceutics from a drug substance perspective and favorable quality characteristics from a tablet formulation perspective suggest that multisource lamotrigine tablets exhibit a low biopharmaceutic risk.
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A Generic Protocol for Intracellular Expression of Recombinant Proteins in Bacillus subtilis.
Phan, Trang; Huynh, Phuong; Truong, Tuom; Nguyen, Hoang
2017-01-01
Bacillus subtilis (B. subtilis) is a potential and attractive host for the production of recombinant proteins. Different expression systems for B. subtilis have been developed recently, and various target proteins have been recombinantly synthesized and purified using this host. In this chapter, we introduce a generic protocol to express a recombinant protein in B. subtilis. It includes protocols for (1) using our typical expression vector (plasmid pHT254) to introduce a target gene, (2) transformation of the target vector into B. subtilis, and (3) evaluation of the actual expression of a recombinant protein.
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Generic approach for synthesizing asymmetric nanoparticles and nanoassemblies
Sun, Yugang; Hu, Yongxing
2015-05-26
A generic route for synthesis of asymmetric nanostructures. This approach utilizes submicron magnetic particles (Fe.sub.3O.sub.4--SiO.sub.2) as recyclable solid substrates for the assembly of asymmetric nanostructures and purification of the final product. Importantly, an additional SiO.sub.2 layer is employed as a mediation layer to allow for selective modification of target nanoparticles. The partially patched nanoparticles are used as building blocks for different kinds of complex asymmetric nanostructures that cannot be fabricated by conventional approaches. The potential applications such as ultra-sensitive substrates for surface enhanced Raman scattering (SERS) have been included.
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NASA Technical Reports Server (NTRS)
Campbell, Stefan F.; Kaneshige, John T.; Nguyen, Nhan T.; Krishakumar, Kalmanje S.
2010-01-01
Presented here is the evaluation of multiple adaptive control technologies for a generic transport aircraft simulation. For this study, seven model reference adaptive control (MRAC) based technologies were considered. Each technology was integrated into an identical dynamic-inversion control architecture and tuned using a methodology based on metrics and specific design requirements. Simulation tests were then performed to evaluate each technology s sensitivity to time-delay, flight condition, model uncertainty, and artificially induced cross-coupling. The resulting robustness and performance characteristics were used to identify potential strengths, weaknesses, and integration challenges of the individual adaptive control technologies
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Entry decisions in the generic pharmaceutical industry.
Morton, F M
1999-01-01
Data on all generic drug entries in the period 1984-1994 are used to estimate which markets heterogeneous potential entrants will decide to enter. I find that organizational experience predicts entry. Firms tend to enter markets with supply and demand characteristics similar to the firm's existing drugs. Larger revenue markets, markets with more hospital sales, and products that treat chronic conditions attract more entry. The simultaneous nature of entry leads to an additional interpretation: specialization is profitable because of the severe risk to profits when a market is "overentered." However, I am unable to make any conclusions about the efficiency of entry decisions.
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Residual life and strength estimates of aircraft structural components with MSD/MED
NASA Technical Reports Server (NTRS)
Singh, Ripudaman; Park, Jai H.; Atluri, Satya N.
1994-01-01
Economic and safe operation of the flight vehicles flying beyond their initial design life calls for an in-depth structural integrity evaluation of all components with potential for catastrophic damages. Fuselage panels with cracked skin and/or stiffening elements is one such example. A three level analytical approach is developed to analyze the pressurized fuselage stiffened shell panels with damaged skin or stiffening elements. A global finite element analysis is first carried out to obtain the load flow pattern through the damaged panel. As an intermediate step, the damaged zone is treated as a spatially three-dimensional structure modeled by plate and shell finite elements, with all the neighboring elements that can alter the stress state at the crack tip. This is followed by the Schwartz-Neumann alternating method for local analysis to obtain the relevant crack tip parameters that govern the onset of fracture and the crack growth. The methodology developed is generic in nature and aims at handling a large fraction of problem areas identified by the Industry Committee on Wide-Spread Fatigue Damage.
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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.
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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.
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[Access to drugs and the situation of the pharmaceutical market in Ecuador].
Ortiz-Prado, Esteban; Galarza, Claudio; León, Fernando Cornejo; Ponce, Jorge
2014-07-01
In the area of public health, it is fundamental to understand the structure and dynamics of the Ecuadorian pharmaceutical market, its segmentation between the public and private sectors, and its relationship with supply and demand, both for generic and brand-name drugs. To achieve this, an observational descriptive study was conducted with information obtained from the available scientific, institutional, technical-administrative, and economic databases. Furthermore, the scientific information concerning the Ecuadorian and regional pharmaceutical market was reviewed through the PubMed and Ovid search engines. In Ecuador, 69.6% of dispensed drugs are brand-name and 30.4% are generics. Of all registered drugs in the country, 1,829 (13.6%) are considered over-the-counter and 11,622 (86.4%) are for sale under medical prescription. In terms of sales, 93.15% correspond to brand-name drugs and only 6.85% to generics. Ninety percent of the pharmacies are located in urban areas and only 10% in rural areas. In the last five years, prices have increased by 12.5% for brand-name drugs and 0.86% for generics. Brand-name drugs are dispensed and consumed 2.3 times more than generics. The majority of pharmacies are located in urban areas, showing that there is a relationship between purchasing power and access to drugs. Although the regulatory authority stipulates that 13% of drugs should be over-the-counter, approximately 60% of the population acquires drugs without a medical prescription.
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Structure of Greyhound hemoglobin: origin of high oxygen affinity.
Bhatt, Veer S; Zaldívar-López, Sara; Harris, David R; Couto, C Guillermo; Wang, Peng G; Palmer, Andre F
2011-05-01
This study presents the crystal structure of Greyhound hemoglobin (GrHb) determined to 1.9 Å resolution. GrHb was found to crystallize with an α₁β₁ dimer in the asymmetric unit and belongs to the R2 state. Oxygen-affinity measurements combined with the fact that GrHb crystallizes in the R2 state despite the high-salt conditions used for crystallization strongly indicate that GrHb can serve as a model high-oxygen-affinity hemoglobin (Hb) for higher mammals, especially humans. Structural analysis of GrHb and its comparison with the R2-state of human Hb revealed several regions that can potentially contribute to the high oxygen affinity of GrHb and serve to rationalize the additional stability of the R2-state of GrHb. A previously well studied hydrophobic cluster of bar-headed goose Hb near α119 was also incorporated in the comparison between GrHb and human Hb. Finally, a structural comparison with generic dog Hb and maned wolf Hb was conducted, revealing that in contrast to GrHb these structures belong to the R state of Hb and raising the intriguing possibility of an additional allosteric factor co-purifying with GrHb that can modulate its quaternary structure.
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Parallel-vector solution of large-scale structural analysis problems on supercomputers
NASA Technical Reports Server (NTRS)
Storaasli, Olaf O.; Nguyen, Duc T.; Agarwal, Tarun K.
1989-01-01
A direct linear equation solution method based on the Choleski factorization procedure is presented which exploits both parallel and vector features of supercomputers. The new equation solver is described, and its performance is evaluated by solving structural analysis problems on three high-performance computers. The method has been implemented using Force, a generic parallel FORTRAN language.
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Implementing Restricted Maximum Likelihood Estimation in Structural Equation Models
ERIC Educational Resources Information Center
Cheung, Mike W.-L.
2013-01-01
Structural equation modeling (SEM) is now a generic modeling framework for many multivariate techniques applied in the social and behavioral sciences. Many statistical models can be considered either as special cases of SEM or as part of the latent variable modeling framework. One popular extension is the use of SEM to conduct linear mixed-effects…
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Results of a Nationwide Survey: Correctional Education Organizational Structure Trends.
ERIC Educational Resources Information Center
Gehring, Thom
1990-01-01
Describes a state-by-state three-part study of the generic types of organizational structures used to deliver correctional education services. The first product was a list of correctional education state directors; this report, including the models used in each state, is the second; and the third was an analysis of correctional school district…
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Infused chemotherapy use in the elderly after patent expiration.
Conti, Rena M; Rosenthal, Meredith B; Polite, Blase N; Bach, Peter B; Shih, Ya-Chen Tina
2012-05-01
The use of anticancer drugs (chemotherapies) is an important determinant of national spending trends. Recent policies have aimed to accelerate generic entry among chemotherapies to generate cost savings. We examined the effects of generic entry on the choice of chemotherapy for the treatment of metastatic colorectal cancer (MCRC) between 2006 and 2009 using autoregressive-moving average modeling with case control. A nationally representative sample of oncologists and patients with cancer (age ≥ 65 years) was employed to estimate the magnitude and significance of the impact of the generic entry of irinotecan in February 2008 on the number of administrations of irinotecan compared with oxaliplatin. The generic entry of irinotecan resulted in a 17% to 19% decrease (P < .001) in use among elderly patients with MCRC compared with oxaliplatin. The results were robust to multiple sensitivity checks. This study provides novel and robust estimates of the decline in use of a chemotherapy to treat a common cancer in the elderly after patent expiration. The results suggest estimates from a previous Office of the Inspector General report of the potential savings derived from the generic entry of irinotecan for public payers are an overestimate, likely confounded by oncologists' response to financial incentives, changes in scientific evidence, and promotional activities. As calls for improving the quality and cost efficiency of oncology increase, future empirical work is needed to examine the responsiveness of oncologists' treatment decision making to incentives among patients of all ages and insurance types.
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Infused chemotherapy use in the elderly after patent expiration.
Conti, Rena M; Rosenthal, Meredith B; Polite, Blase N; Bach, Peter B; Shih, Ya-Chen Tina
2012-05-01
The use of anticancer drugs (chemotherapies) is an important determinant of national spending trends. Recent policies have aimed to accelerate generic entry among chemotherapies to generate cost savings. We examined the effects of generic entry on the choice of chemotherapy for the treatment of metastatic colorectal cancer (MCRC) between 2006 and 2009 using autoregressivemoving average modeling with case control. A nationally representative sample of oncologists and patients with cancer (aged ≥65 years) was employed to estimate the magnitude and significance of the impact of the generic entry of irinotecan in February 2008 on the number of administrations of irinotecan compared with oxaliplatin. The generic entry of irinotecan resulted in a 17% to 19% decrease (P <.001) in use among elderly patients with MCRC compared with oxaliplatin. The results were robust to multiple sensitivity checks. This study provides novel and robust estimates of the decline in use of a chemotherapy to treat a common cancer in the elderly after patent expiration. The results suggest estimates from a previous Office of the Inspector General report of the potential savings derived from the generic entry of irinotecan for public payers are an overestimate, likely confounded by oncologists' response to financial incentives, changes in scientific evidence, and promotional activities. As calls for improving the quality and cost efficiency of oncology increase, future empirical work is needed to examine the responsiveness of oncologists' treatment decision making to incentives among patients of all ages and insurance types.
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Generic functional requirements for a NASA general-purpose data base management system
NASA Technical Reports Server (NTRS)
Lohman, G. M.
1981-01-01
Generic functional requirements for a general-purpose, multi-mission data base management system (DBMS) for application to remotely sensed scientific data bases are detailed. The motivation for utilizing DBMS technology in this environment is explained. The major requirements include: (1) a DBMS for scientific observational data; (2) a multi-mission capability; (3) user-friendly; (4) extensive and integrated information about data; (5) robust languages for defining data structures and formats; (6) scientific data types and structures; (7) flexible physical access mechanisms; (8) ways of representing spatial relationships; (9) a high level nonprocedural interactive query and data manipulation language; (10) data base maintenance utilities; (11) high rate input/output and large data volume storage; and adaptability to a distributed data base and/or data base machine configuration. Detailed functions are specified in a top-down hierarchic fashion. Implementation, performance, and support requirements are also given.
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New generic indexing technology
NASA Technical Reports Server (NTRS)
Freeston, Michael
1996-01-01
There has been no fundamental change in the dynamic indexing methods supporting database systems since the invention of the B-tree twenty-five years ago. And yet the whole classical approach to dynamic database indexing has long since become inappropriate and increasingly inadequate. We are moving rapidly from the conventional one-dimensional world of fixed-structure text and numbers to a multi-dimensional world of variable structures, objects and images, in space and time. But, even before leaving the confines of conventional database indexing, the situation is highly unsatisfactory. In fact, our research has led us to question the basic assumptions of conventional database indexing. We have spent the past ten years studying the properties of multi-dimensional indexing methods, and in this paper we draw the strands of a number of developments together - some quite old, some very new, to show how we now have the basis for a new generic indexing technology for the next generation of database systems.
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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.
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The Researching on Evaluation of Automatic Voltage Control Based on Improved Zoning Methodology
NASA Astrophysics Data System (ADS)
Xiao-jun, ZHU; Ang, FU; Guang-de, DONG; Rui-miao, WANG; De-fen, ZHU
2018-03-01
According to the present serious phenomenon of increasing size and structure of power system, hierarchically structured automatic voltage control(AVC) has been the researching spot. In the paper, the reduced control model is built and the adaptive reduced control model is researched to improve the voltage control effect. The theories of HCSD, HCVS, SKC and FCM are introduced and the effect on coordinated voltage regulation caused by different zoning methodologies is also researched. The generic framework for evaluating performance of coordinated voltage regulation is built. Finally, the IEEE-96 stsyem is used to divide the network. The 2383-bus Polish system is built to verify that the selection of a zoning methodology affects not only the coordinated voltage regulation operation, but also its robustness to erroneous data and proposes a comprehensive generic framework for evaluating its performance. The New England 39-bus network is used to verify the adaptive reduced control models’ performance.
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First stage identification of syntactic elements in an extra-terrestrial signal
NASA Astrophysics Data System (ADS)
Elliott, John
2011-02-01
By investigating the generic attributes of a representative set of terrestrial languages at varying levels of abstraction, it is our endeavour to try and isolate elements of the signal universe, which are computationally tractable for its detection and structural decipherment. Ultimately, our aim is to contribute in some way to the understanding of what 'languageness' actually is. This paper describes algorithms and software developed to characterise and detect generic intelligent language-like features in an input signal, using natural language learning techniques: looking for characteristic statistical "language-signatures" in test corpora. As a first step towards such species-independent language-detection, we present a suite of programs to analyse digital representations of a range of data, and use the results to extrapolate whether or not there are language-like structures which distinguish this data from other sources, such as music, images, and white noise.
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NASA Astrophysics Data System (ADS)
Hütter, Markus; Svendsen, Bob
2013-11-01
An essential part in modeling out-of-equilibrium dynamics is the formulation of irreversible dynamics. In the latter, the major task consists in specifying the relations between thermodynamic forces and fluxes. In the literature, mainly two distinct approaches are used for the specification of force-flux relations. On the one hand, quasi-linear relations are employed, which are based on the physics of transport processes and fluctuation-dissipation theorems (de Groot and Mazur in Non-equilibrium thermodynamics, North Holland, Amsterdam, 1962, Lifshitz and Pitaevskii in Physical kinetics. Volume 10, Landau and Lifshitz series on theoretical physics, Pergamon Press, Oxford, 1981). On the other hand, force-flux relations are also often represented in potential form with the help of a dissipation potential (Šilhavý in The mechanics and thermodynamics of continuous media, Springer, Berlin, 1997). We address the question of how these two approaches are related. The main result of this presentation states that the class of models formulated by quasi-linear relations is larger than what can be described in a potential-based formulation. While the relation between the two methods is shown in general terms, it is demonstrated also with the help of three examples. The finding that quasi-linear force-flux relations are more general than dissipation-based ones also has ramifications for the general equation for non-equilibrium reversible-irreversible coupling (GENERIC: e.g., Grmela and Öttinger in Phys Rev E 56:6620-6632, 6633-6655, 1997, Öttinger in Beyond equilibrium thermodynamics, Wiley Interscience Publishers, Hoboken, 2005). This framework has been formulated and used in two different forms, namely a quasi-linear (Öttinger and Grmela in Phys Rev E 56:6633-6655, 1997, Öttinger in Beyond equilibrium thermodynamics, Wiley Interscience Publishers, Hoboken, 2005) and a dissipation potential-based (Grmela in Adv Chem Eng 39:75-129, 2010, Grmela in J Non-Newton Fluid Mech 165:980-986, 2010, Mielke in Continuum Mech Therm 23:233-256, 2011) form, respectively, relating the irreversible evolution to the entropy gradient. It is found that also in the case of GENERIC, the quasi-linear representation encompasses a wider class of phenomena as compared to the dissipation-based formulation. Furthermore, it is found that a potential exists for the irreversible part of the GENERIC if and only if one does for the underlying force-flux relations.
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Comparison of generic-to-brand switchback patterns for generic and authorized generic drugs
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
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Integrated corridor management analysis, modeling and simulation (AMS) methodology.
DOT National Transportation Integrated Search
2008-03-01
This AMS Methodologies Document provides a discussion of potential ICM analytical approaches for the assessment of generic corridor operations. The AMS framework described in this report identifies strategies and procedures for tailoring AMS general ...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-27
... and efficiency of existing products and services; to obtain knowledge about the potential public... audiences and customers. Current Actions: None. Type of Review: Extension. Affected Public: Individuals or...
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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
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Thai generic-brand dry canine foods: mutagenicity and the effects of feeding in vivo and in vitro.
Khuntamoon, Tanyalak; Thepouyporn, Apanchanid; Kaewprasert, Sarunya; Prangthip, Pattaneeya; Pooudoung, Somchai; Chaisri, Urai; Maneesai, Phudit; Kwanbunjan, Karunee
2016-01-20
The commercial pet-food industry and the market value of the pet industry have increased. Most owners are concerned about their pets' health, and prefer commercial pet foods as their regular diet. This study thus aimed to determine whether a selection of local generic-brand dry canine foods had any potential to promote chronic disease. Five local, generic-brand, dry canine foods were studied for potential mutagenicity; the effects of long-term consumption were also observed in rats. All canine foods were extracted with distilled water and absolute ethanol. The Ames test was used to detect short-term genetic damage, using Salmonella typhimurium tester strains TA98 and TA100. Simultaneously, the long-term effects were studied in an animal model by observing rats fed with these canine foods, compared with normal rat food, for a period of 15 weeks. Using the water extracts, all dry canine foods studied showed considerable mutagenic effects on the tester strains. One brand affected both tester strains, whereas 3 showed positive to TA98, and one to TA100. With the absolute ethanol extract, three of the five brands had a considerable mutagenic effect on TA98, and another affected TA100. In the long-term test, all rats remained alive until the end of the experiment, exhibited no apparent signs of toxicity or serious illness, and maintained normal bodyweight and weight gain. Serum blood biochemistry and hematological parameters in canine food-fed rats showed some negative effects. Correspondingly, histopathological investigation of their liver and kidneys showed deterioration. Mutagenic potential and the negative potential health impacts were observed in all local-brand dry canine foods tested.
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NASA Astrophysics Data System (ADS)
Ionescu, Clara M.; Copot, Cosmin; Verellen, Dirk
2017-03-01
The purpose of this work is to integrate the concept of patient-in-the-closed-loop application with tumour treatment of cancer-diagnosed patients in remote areas. The generic closed loop control objective is effective synchronisation of the radiation focus to the movement of a lung tissue tumour during actual breathing of the patient. This is facilitated by accurate repositioning of a robotic arm manipulator, i.e. we emulate the Cyberknife Robotic Radiosurgery system. Predictive control with disturbance filter is used in this application in a minimalistic model design. Performance of the control structure is validated by means of simulation using real recorded breathing patterns from patients measured in 3D space. Latency in communication protocol is taken into account, given telerobotics involve autonomous operation of a robot interacting with a human being in different location. Our results suggest that the proposed closed loop control structure has practical potential to individualise the treatment and improves accuracy by at least 15%.
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Morphew, Daniel; Shaw, James; Avins, Christopher; Chakrabarti, Dwaipayan
2018-03-27
Colloidal self-assembly is a promising bottom-up route to a wide variety of three-dimensional structures, from clusters to crystals. Programming hierarchical self-assembly of colloidal building blocks, which can give rise to structures ordered at multiple levels to rival biological complexity, poses a multiscale design problem. Here we explore a generic design principle that exploits a hierarchy of interaction strengths and employ this design principle in computer simulations to demonstrate the hierarchical self-assembly of triblock patchy colloidal particles into two distinct colloidal crystals. We obtain cubic diamond and body-centered cubic crystals via distinct clusters of uniform size and shape, namely, tetrahedra and octahedra, respectively. Such a conceptual design framework has the potential to reliably encode hierarchical self-assembly of colloidal particles into a high level of sophistication. Moreover, the design framework underpins a bottom-up route to cubic diamond colloidal crystals, which have remained elusive despite being much sought after for their attractive photonic applications.
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Dust as a versatile matter for high-temperature plasma diagnostic.
Wang, Zhehui; Ticos, Catalin M
2008-10-01
Dust varies from a few nanometers to a fraction of a millimeter in size. Dust also offers essentially unlimited choices in material composition and structure. The potential of dust for high-temperature plasma diagnostic is largely unfulfilled yet. The principles of dust spectroscopy to measure internal magnetic field, microparticle tracer velocimetry to measure plasma flow, and dust photometry to measure heat flux are described. Two main components of the different dust diagnostics are a dust injector and a dust imaging system. The dust injector delivers a certain number of dust grains into a plasma. The imaging system collects and selectively detects certain photons resulted from dust-plasma interaction. One piece of dust gives the local plasma quantity, a collection of dust grains together reveals either two-dimensional (using only one or two imaging cameras) or three-dimensional (using two or more imaging cameras) structures of the measured quantity. A generic conceptual design suitable for all three types of dust diagnostics is presented.
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Simons, Sereh M J; Cillessen, Felix H J M; Hazelzet, Jan A
2016-08-02
A problem-oriented approach is one of the possibilities to organize a medical record. The problem-oriented medical record (POMR) - a structured organization of patient information per presented medical problem- was introduced at the end of the sixties by Dr. Lawrence Weed to aid dealing with the multiplicity of patient problems. The problem list as a precondition is the centerpiece of the problem-oriented medical record (POMR) also called problem-oriented record (POR). Prior to the digital era, paper records presented a flat list of medical problems to the healthcare professional without the features that are possible with current technology. In modern EHRs a POMR based on a structured problem list can be used for clinical decision support, registries, order management, population health, and potentially other innovative functionality in the future, thereby providing a new incentive to the implementation and use of the POMR. On both 12 May 2014 and 1 June 2015 a systematic literature search was conducted. From the retrieved articles statements regarding the POMR and related to successful or non-successful implementation, were categorized. Generic determinants were extracted from these statements. In this research 38 articles were included. The literature analysis led to 12 generic determinants: clinical practice/reasoning, complete and accurate problem list, data structure/content, efficiency, functionality, interoperability, multi-disciplinary, overview of patient information, quality of care, system support, training of staff, and usability. Two main subjects can be distinguished in the determinants: the system that the problem list and POMR is integrated in and the organization using that system. The combination of the two requires a sociotechnical approach and both are equally important for successful implementation of a POMR. All the determinants have to be taken into account, but the weight given to each of the determinants depends on the organizationusing the problem list or POMR.
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Qu, Liangti; Vaia, Rich A; Dai, Liming
2011-02-22
A simple multiple contact transfer technique has been developed for controllable fabrication of multilevel, multicomponent microarchitectures of vertically aligned carbon nanotubes (VA-CNTs). Three dimensional (3-D) multicomponent micropatterns of aligned single-walled carbon nanotubes (SWNTs) and multiwalled carbon nanotubes (MWNTs) have been fabricated, which can be used to develop a newly designed touch sensor with reversible electrical responses for potential applications in electronic devices, as demonstrated in this study. The demonstrated dependence of light diffraction on structural transfiguration of the resultant CNT micropattern also indicates their potential for optical devices. Further introduction of various components with specific properties (e.g., ZnO nanorods) into the CNT micropatterns enabled us to tailor such surface characteristics as wettability and light response. Owing to the highly generic nature of the multiple contact transfer strategy, the methodology developed here could provide a general approach for interposing a large variety of multicomponent elements (e.g., nanotubes, nanorods/wires, photonic crystals, etc.) onto a single chip for multifunctional device applications.
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Simplicity of condensed matter at its core: generic definition of a Roskilde-simple system.
Schrøder, Thomas B; Dyre, Jeppe C
2014-11-28
The isomorph theory is reformulated by defining Roskilde-simple systems by the property that the order of the potential energies of configurations at one density is maintained when these are scaled uniformly to a different density. If the potential energy as a function of all particle coordinates is denoted by U(R), this requirement translates into U(Ra) < U(Rb) ⇒ U(λRa) < U(λRb). Isomorphs remain curves in the thermodynamic phase diagram along which structure, dynamics, and excess entropy are invariant, implying that the phase diagram is effectively one-dimensional with respect to many reduced-unit properties. In contrast to the original formulation of the isomorph theory, however, the density-scaling exponent is not exclusively a function of density and the isochoric heat capacity is not an exact isomorph invariant. A prediction is given for the latter quantity's variation along the isomorphs. Molecular dynamics simulations of the Lennard-Jones and Lennard-Jones Gaussian systems validate the new approach.
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Song, Qingfeng; Chen, Dairui; Long, Stephen P; Zhu, Xin-Guang
2017-01-01
Windows Intuitive Model of Vegetation response to Atmosphere and Climate Change (WIMOVAC) has been used widely as a generic modular mechanistically rich model of plant production. It can predict the responses of leaf and canopy carbon balance, as well as production in different environmental conditions, in particular those relevant to global change. Here, we introduce an open source Java user-friendly version of WIMOVAC. This software is platform independent and can be easily downloaded to a laptop and used without any prior programming skills. In this article, we describe the structure, equations and user guide and illustrate some potential applications of WIMOVAC. © 2016 The Authors Plant, Cell & Environment Published by John Wiley & Sons Ltd.
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NASA Technical Reports Server (NTRS)
Kharisov, Evgeny; Gregory, Irene M.; Cao, Chengyu; Hovakimyan, Naira
2008-01-01
This paper explores application of the L1 adaptive control architecture to a generic flexible Crew Launch Vehicle (CLV). Adaptive control has the potential to improve performance and enhance safety of space vehicles that often operate in very unforgiving and occasionally highly uncertain environments. NASA s development of the next generation space launch vehicles presents an opportunity for adaptive control to contribute to improved performance of this statically unstable vehicle with low damping and low bending frequency flexible dynamics. In this paper, we consider the L1 adaptive output feedback controller to control the low frequency structural modes and propose steps to validate the adaptive controller performance utilizing one of the experimental test flights for the CLV Ares-I Program.
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Real-Time Adaptive Least-Squares Drag Minimization for Performance Adaptive Aeroelastic Wing
NASA Technical Reports Server (NTRS)
Ferrier, Yvonne L.; Nguyen, Nhan T.; Ting, Eric
2016-01-01
This paper contains a simulation study of a real-time adaptive least-squares drag minimization algorithm for an aeroelastic model of a flexible wing aircraft. The aircraft model is based on the NASA Generic Transport Model (GTM). The wing structures incorporate a novel aerodynamic control surface known as the Variable Camber Continuous Trailing Edge Flap (VCCTEF). The drag minimization algorithm uses the Newton-Raphson method to find the optimal VCCTEF deflections for minimum drag in the context of an altitude-hold flight control mode at cruise conditions. The aerodynamic coefficient parameters used in this optimization method are identified in real-time using Recursive Least Squares (RLS). The results demonstrate the potential of the VCCTEF to improve aerodynamic efficiency for drag minimization for transport aircraft.
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NASA Astrophysics Data System (ADS)
Kassim, Syara; Zahari, Siti Balqis; Tahrin, Rabiatul Addawiyah Azwa; Harun, Noor Aniza
2017-09-01
Photonic crystals are being the great interest of researcher to studies due to a variety of potential application for the interaction of light including the solar cells, optical sensors and paints. In order to evaluate the fabrication of photonic crystals thin film, a free-emulsifier emulsion copolymerization of styrene and methyl methacrylate was carried out. By using the self -assembly approach, this method offers the opportunity to produce crystalline polymer sphere in more ease operation, low cost and environmental friendly. The influences of the mixing ratio of monomer and amount of initiators were studied. In advance, the presence of styrene as co-monomer had improved the thermal degradation of polymer methyl methacrylate. While in changing the mixing ratio of styrene and methyl methacrylate resulted in particle size of the sphere. The size of polymer particles slightly increased on increasing volume of styrene monomer ratio. This occurred because the properties of styrene in water where it sparingly soluble and lead to coagulation of particles. This simple, yet effective method for preparing functional complex 3D structures has the potential to be used generically to fabricate a variety of functional porous 3D structures that could find application not only in new or improved photonic crystal (PC) devices but also in areas such as catalysis, solar cell, separation, fuel cells technology, microelectronics and optoelectronics.
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Mapping Risks of Indonesian Tuna Supply Chain
NASA Astrophysics Data System (ADS)
Karningsih, P. D.; Anggrahini, D.; Kurniati, N.; Suef, M.; Fachrur, A. R.; Syahroni, N.
2018-04-01
Due to its high economic value and is produced by many countries, Tuna is considered as one of the world’s popular fish. Demand for Tuna species are very high and it usually sells in three form: fresh, frozen or canned. Competition in Tuna trading is challengin with the potential risk of price and supply fluctuations. With recent focus of Indonesia government that see the future of Indonesia civilization depend on the oceans and as the three biggest Tuna producing country, Ministry of Marine Affairs and Fisheries should ensure sustainability and competitiveness of Indonesian tuna. Therefore, there is a great need to develop a proper and effective strategy to manage potential risks in Indonesian Tuna supply chain. This paper is aimed at identifying and mapping potential Tuna supply chain risks and its interrelationships that would assist government in determining proper strategies to manage Indonesian Tuna. A framework for identifying Tuna supply chain risks is proposed. Generic risk structure of Supply Chain Risk Identification System is adopted and modified to match with particular object, which is Indonesian Tuna. The proposed model consists of hierarchical and causal structure that encompass potential risks of Tuna supply chain operations from fishing, trading, processing and distribution. The causal structure consist of risk events and its risk agents which is the cause of risk events. To ensure the root cause of risk events are identified properly, five why’s analysis is utilized to obtain risk agents. This proposed model also captures risk interrelationship between internal and external environment of Tuna supply chain. Preliminary result of this study identifies 15 risk events and 13 risk factors on fishing and trading operations and maps their interrelationships.
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An Aerodynamic Analysis of a Spinning Missile with Dithering Canards
NASA Technical Reports Server (NTRS)
Meakin, Robert L.; Nygaard, Tor A.
2003-01-01
A generic spinning missile with dithering canards is used to demonstrate the utility of an overset structured grid approach for simulating the aerodynamics of rolling airframe missile systems. The approach is used to generate a modest aerodynamic database for the generic missile. The database is populated with solutions to the Euler and Navier-Stokes equations. It is used to evaluate grid resolution requirements for accurate prediction of instantaneous missile loads and the relative aerodynamic significance of angle-of-attack, canard pitching sequence, viscous effects, and roll-rate effects. A novel analytical method for inter- and extrapolation of database results is also given.
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Potential applications of electron emission membranes in medicine
NASA Astrophysics Data System (ADS)
Bilevych, Yevgen; Brunner, Stefan E.; Chan, Hong Wah; Charbon, Edoardo; van der Graaf, Harry; Hagen, Cornelis W.; Nützel, Gert; Pinto, Serge D.; Prodanović, Violeta; Rotman, Daan; Santagata, Fabio; Sarro, Lina; Schaart, Dennis R.; Sinsheimer, John; Smedley, John; Tao, Shuxia; Theulings, Anne M. M. G.
2016-02-01
With a miniaturised stack of transmission dynodes, a noise free amplifier is being developed for the detection of single free electrons, with excellent time- and 2D spatial resolution and efficiency. With this generic technology, a new family of detectors for individual elementary particles may become possible. Potential applications of such electron emission membranes in medicine are discussed.
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Saadawi, Gilan M; Harrison, James H
2006-10-01
Clinical laboratory procedure manuals are typically maintained as word processor files and are inefficient to store and search, require substantial effort for review and updating, and integrate poorly with other laboratory information. Electronic document management systems could improve procedure management and utility. As a first step toward building such systems, we have developed a prototype electronic format for laboratory procedures using Extensible Markup Language (XML). Representative laboratory procedures were analyzed to identify document structure and data elements. This information was used to create a markup vocabulary, CLP-ML, expressed as an XML Document Type Definition (DTD). To determine whether this markup provided advantages over generic markup, we compared procedures structured with CLP-ML or with the vocabulary of the Health Level Seven, Inc. (HL7) Clinical Document Architecture (CDA) narrative block. CLP-ML includes 124 XML tags and supports a variety of procedure types across different laboratory sections. When compared with a general-purpose markup vocabulary (CDA narrative block), CLP-ML documents were easier to edit and read, less complex structurally, and simpler to traverse for searching and retrieval. In combination with appropriate software, CLP-ML is designed to support electronic authoring, reviewing, distributing, and searching of clinical laboratory procedures from a central repository, decreasing procedure maintenance effort and increasing the utility of procedure information. A standard electronic procedure format could also allow laboratories and vendors to share procedures and procedure layouts, minimizing duplicative word processor editing. Our results suggest that laboratory-specific markup such as CLP-ML will provide greater benefit for such systems than generic markup.
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Disentangling the f(R)-duality
DOE Office of Scientific and Technical Information (OSTI.GOV)
Broy, Benedict J.; Pedro, Francisco G.; Westphal, Alexander
2015-03-16
Motivated by UV realisations of Starobinsky-like inflation models, we study generic exponential plateau-like potentials to understand whether an exact f(R)-formulation may still be obtained when the asymptotic shift-symmetry of the potential is broken for larger field values. Potentials which break the shift symmetry with rising exponentials at large field values only allow for corresponding f(R)-descriptions with a leading order term R{sup n} with 1
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Disentangling the f(R)-duality
DOE Office of Scientific and Technical Information (OSTI.GOV)
Broy, Benedict J.; Westphal, Alexander; Pedro, Francisco G., E-mail: benedict.broy@desy.de, E-mail: francisco.pedro@desy.de, E-mail: alexander.westphal@desy.de
2015-03-01
Motivated by UV realisations of Starobinsky-like inflation models, we study generic exponential plateau-like potentials to understand whether an exact f(R)-formulation may still be obtained when the asymptotic shift-symmetry of the potential is broken for larger field values. Potentials which break the shift symmetry with rising exponentials at large field values only allow for corresponding f(R)-descriptions with a leading order term R{sup n} with 1
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ERIC Educational Resources Information Center
Singh, Sukhdev; Bedi, Navkiran Kaur
2013-01-01
Every text has a communicative purpose that it performs by dividing itself into generic stages. These stages are assigned specific goals and have differing linguistic structures. This paper makes an attempt to investigate whether there is a definable co-relation between linguistic features and stages in the genre of look-good advertisements. It…
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Fixed-dose combination and single active ingredient drugs: a comparative cost analysis.
Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique
2016-01-01
Fixed-dose combination (FDC) drugs are formulations of two or more active ingredients. To assess the pricing structure and price difference of all US FDA-approved FDCs and single drugs included in the combination. Data were collected from the FDA Orange Book and Drugs@FDA. Average Wholesale Price (AWP) unit price data were derived from The Red Book. The FDA approved 117 FDC. The average AWP difference percentage between the FDC and the sum of the single drugs in the FDC is 84.9 ± 26.2%, and varied by therapeutic class (p < 0.001). The FDC AWP averaged 83.3 ± 23.4% of the single drug AWP sum when there are no generics, and 95.1 ± 42.3% (p < 0.01) when there are two generic single active ingredients in the FDC. The price difference between FDC and single active ingredients in the combination is correlated with the therapeutic class, the year of FDC approval, and the number of single ingredients in the combination that have generics.
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NASA Astrophysics Data System (ADS)
Servigne, S.; Gripay, Y.; Pinarer, O.; Samuel, J.; Ozgovde, A.; Jay, J.
2016-09-01
Concerning energy consumption and monitoring architectures, our goal is to develop a sustainable declarative monitoring architecture for lower energy consumption taking into account the monitoring system itself. Our second is to develop theoretical and practical tools to model, explore and exploit heterogeneous data from various sources in order to understand a phenomenon like energy consumption of smart building vs inhabitants' social behaviours. We focus on a generic model for data acquisition campaigns based on the concept of generic sensor. The concept of generic sensor is centered on acquired data and on their inherent multi-dimensional structure, to support complex domain-specific or field-oriented analysis processes. We consider that a methodological breakthrough may pave the way to deep understanding of voluminous and heterogeneous scientific data sets. Our use case concerns energy efficiency of buildings to understand relationship between physical phenomena and user behaviors. The aim of this paper is to give a presentation of our methodology and results concerning architecture and user-centric tools.
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Big Bang Bifurcation Analysis and Allee Effect in Generic Growth Functions
NASA Astrophysics Data System (ADS)
Leonel Rocha, J.; Taha, Abdel-Kaddous; Fournier-Prunaret, D.
2016-06-01
The main purpose of this work is to study the dynamics and bifurcation properties of generic growth functions, which are defined by the population size functions of the generic growth equation. This family of unimodal maps naturally incorporates a principal focus of ecological and biological research: the Allee effect. The analysis of this kind of extinction phenomenon allows to identify a class of Allee’s functions and characterize the corresponding Allee’s effect region and Allee’s bifurcation curve. The bifurcation analysis is founded on the performance of fold and flip bifurcations. The dynamical behavior is rich with abundant complex bifurcation structures, the big bang bifurcations of the so-called “box-within-a-box” fractal type being the most outstanding. Moreover, these bifurcation cascades converge to different big bang bifurcation curves with distinct kinds of boxes, where for the corresponding parameter values several attractors are associated. To the best of our knowledge, these results represent an original contribution to clarify the big bang bifurcation analysis of continuous 1D maps.
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NASA Astrophysics Data System (ADS)
Liu, Zexi; Cohen, Fernand
2017-11-01
We describe an approach for synthesizing a three-dimensional (3-D) face structure from an image or images of a human face taken at a priori unknown poses using gender and ethnicity specific 3-D generic models. The synthesis process starts with a generic model, which is personalized as images of the person become available using preselected landmark points that are tessellated to form a high-resolution triangular mesh. From a single image, two of the three coordinates of the model are reconstructed in accordance with the given image of the person, while the third coordinate is sampled from the generic model, and the appearance is made in accordance with the image. With multiple images, all coordinates and appearance are reconstructed in accordance with the observed images. This method allows for accurate pose estimation as well as face identification in 3-D rendering of a difficult two-dimensional (2-D) face recognition problem into a much simpler 3-D surface matching problem. The estimation of the unknown pose is achieved using the Levenberg-Marquardt optimization process. Encouraging experimental results are obtained in a controlled environment with high-resolution images under a good illumination condition, as well as for images taken in an uncontrolled environment under arbitrary illumination with low-resolution cameras.
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Budday, Dominik; Leyendecker, Sigrid; van den Bedem, Henry
2015-01-01
Proteins operate and interact with partners by dynamically exchanging between functional substates of a conformational ensemble on a rugged free energy landscape. Understanding how these substates are linked by coordinated, collective motions requires exploring a high-dimensional space, which remains a tremendous challenge. While molecular dynamics simulations can provide atomically detailed insight into the dynamics, computational demands to adequately sample conformational ensembles of large biomolecules and their complexes often require tremendous resources. Kinematic models can provide high-level insights into conformational ensembles and molecular rigidity beyond the reach of molecular dynamics by reducing the dimensionality of the search space. Here, we model a protein as a kinematic linkage and present a new geometric method to characterize molecular rigidity from the constraint manifold Q and its tangent space Q at the current configuration q. In contrast to methods based on combinatorial constraint counting, our method is valid for both generic and non-generic, e.g., singular configurations. Importantly, our geometric approach provides an explicit basis for collective motions along floppy modes, resulting in an efficient procedure to probe conformational space. An atomically detailed structural characterization of coordinated, collective motions would allow us to engineer or allosterically modulate biomolecules by selectively stabilizing conformations that enhance or inhibit function with broad implications for human health. PMID:26213417
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NASA Astrophysics Data System (ADS)
Budday, Dominik; Leyendecker, Sigrid; van den Bedem, Henry
2015-10-01
Proteins operate and interact with partners by dynamically exchanging between functional substates of a conformational ensemble on a rugged free energy landscape. Understanding how these substates are linked by coordinated, collective motions requires exploring a high-dimensional space, which remains a tremendous challenge. While molecular dynamics simulations can provide atomically detailed insight into the dynamics, computational demands to adequately sample conformational ensembles of large biomolecules and their complexes often require tremendous resources. Kinematic models can provide high-level insights into conformational ensembles and molecular rigidity beyond the reach of molecular dynamics by reducing the dimensionality of the search space. Here, we model a protein as a kinematic linkage and present a new geometric method to characterize molecular rigidity from the constraint manifold Q and its tangent space Tq Q at the current configuration q. In contrast to methods based on combinatorial constraint counting, our method is valid for both generic and non-generic, e.g., singular configurations. Importantly, our geometric approach provides an explicit basis for collective motions along floppy modes, resulting in an efficient procedure to probe conformational space. An atomically detailed structural characterization of coordinated, collective motions would allow us to engineer or allosterically modulate biomolecules by selectively stabilizing conformations that enhance or inhibit function with broad implications for human health.
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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.
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Dynamic and thermal response finite element models of multi-body space structural configurations
NASA Technical Reports Server (NTRS)
Edighoffer, Harold H.
1987-01-01
Presented is structural dynamics modeling of two multibody space structural configurations. The first configuration is a generic space station model of a cylindrical habitation module, two solar array panels, radiator panel, and central connecting tube. The second is a 15-m hoop-column antenna. Discussed is the special joint elimination sequence used for these large finite element models, so that eigenvalues could be extracted. The generic space station model aided test configuration design and analysis/test data correlation. The model consisted of six finite element models, one of each substructure and one of all substructures as a system. Static analysis and tests at the substructure level fine-tuned the finite element models. The 15-m hoop-column antenna is a truss column and structural ring interconnected with tension stabilizing cables. To the cables, pretensioned mesh membrane elements were attached to form four parabolic shaped antennae, one per quadrant. Imposing thermal preloads in the cables and mesh elements produced pretension in the finite element model. Thermal preload variation in the 96 control cables was adjusted to maintain antenna shape within the required tolerance and to give pointing accuracy.
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2014-01-01
Background Health impairments can result in disability and changed work productivity imposing considerable costs for the employee, employer and society as a whole. A large number of instruments exist to measure health-related productivity changes; however their methodological quality remains unclear. This systematic review critically appraised the measurement properties in generic self-reported instruments that measure health-related productivity changes to recommend appropriate instruments for use in occupational and economic health practice. Methods PubMed, PsycINFO, Econlit and Embase were systematically searched for studies whereof: (i) instruments measured health-related productivity changes; (ii) the aim was to evaluate instrument measurement properties; (iii) instruments were generic; (iv) ratings were self-reported; (v) full-texts were available. Next, methodological quality appraisal was based on COSMIN elements: (i) internal consistency; (ii) reliability; (iii) measurement error; (iv) content validity; (v) structural validity; (vi) hypotheses testing; (vii) cross-cultural validity; (viii) criterion validity; and (ix) responsiveness. Recommendations are based on evidence syntheses. Results This review included 25 articles assessing the reliability, validity and responsiveness of 15 different generic self-reported instruments measuring health-related productivity changes. Most studies evaluated criterion validity, none evaluated cross-cultural validity and information on measurement error is lacking. The Work Limitation Questionnaire (WLQ) was most frequently evaluated with moderate respectively strong positive evidence for content and structural validity and negative evidence for reliability, hypothesis testing and responsiveness. Less frequently evaluated, the Stanford Presenteeism Scale (SPS) showed strong positive evidence for internal consistency and structural validity, and moderate positive evidence for hypotheses testing and criterion validity. The Productivity and Disease Questionnaire (PRODISQ) yielded strong positive evidence for content validity, evidence for other properties is lacking. The other instruments resulted in mostly fair-to-poor quality ratings with limited evidence. Conclusions Decisions based on the content of the instrument, usage purpose, target country and population, and available evidence are recommended. Until high-quality studies are in place to accurately assess the measurement properties of the currently available instruments, the WLQ and, in a Dutch context, the PRODISQ are cautiously preferred based on its strong positive evidence for content validity. Based on its strong positive evidence for internal consistency and structural validity, the SPS is cautiously recommended. PMID:24495301
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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.
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Dynamic Positioning System (DPS) Risk Analysis Using Probabilistic Risk Assessment (PRA)
NASA Technical Reports Server (NTRS)
Thigpen, Eric B.; Boyer, Roger L.; Stewart, Michael A.; Fougere, Pete
2017-01-01
The National Aeronautics and Space Administration (NASA) Safety & Mission Assurance (S&MA) directorate at the Johnson Space Center (JSC) has applied its knowledge and experience with Probabilistic Risk Assessment (PRA) to projects in industries ranging from spacecraft to nuclear power plants. PRA is a comprehensive and structured process for analyzing risk in complex engineered systems and/or processes. The PRA process enables the user to identify potential risk contributors such as, hardware and software failure, human error, and external events. Recent developments in the oil and gas industry have presented opportunities for NASA to lend their PRA expertise to both ongoing and developmental projects within the industry. This paper provides an overview of the PRA process and demonstrates how this process was applied in estimating the probability that a Mobile Offshore Drilling Unit (MODU) operating in the Gulf of Mexico and equipped with a generically configured Dynamic Positioning System (DPS) loses location and needs to initiate an emergency disconnect. The PRA described in this paper is intended to be generic such that the vessel meets the general requirements of an International Maritime Organization (IMO) Maritime Safety Committee (MSC)/Circ. 645 Class 3 dynamically positioned vessel. The results of this analysis are not intended to be applied to any specific drilling vessel, although provisions were made to allow the analysis to be configured to a specific vessel if required.
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A Generic Force Field for Protein Coarse-Grained Molecular Dynamics Simulation
Gu, Junfeng; Bai, Fang; Li, Honglin; Wang, Xicheng
2012-01-01
Coarse-grained (CG) force fields have become promising tools for studies of protein behavior, but the balance of speed and accuracy is still a challenge in the research of protein coarse graining methodology. In this work, 20 CG beads have been designed based on the structures of amino acid residues, with which an amino acid can be represented by one or two beads, and a CG solvent model with five water molecules was adopted to ensure the consistence with the protein CG beads. The internal interactions in protein were classified according to the types of the interacting CG beads, and adequate potential functions were chosen and systematically parameterized to fit the energy distributions. The proposed CG force field has been tested on eight proteins, and each protein was simulated for 1000 ns. Even without any extra structure knowledge of the simulated proteins, the Cα root mean square deviations (RMSDs) with respect to their experimental structures are close to those of relatively short time all atom molecular dynamics simulations. However, our coarse grained force field will require further refinement to improve agreement with and persistence of native-like structures. In addition, the root mean square fluctuations (RMSFs) relative to the average structures derived from the simulations show that the conformational fluctuations of the proteins can be sampled. PMID:23203075
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Hill, Andrew; Hill, Teresa; Jose, Sophie; Pozniak, Anton
2014-01-01
In other disease areas, generic drugs are normally used after patent expiry. Patents on zidovudine, lamivudine, nevirapine and efavirenz have already expired. Patents will expire for abacavir in late 2014, lopinavir/r in 2016, and tenofovir, darunavir and atazanavir in 2017. However, patents on single-tablet regimens do not expire until after 2026. The number of people taking each antiretroviral in the UK was estimated from 23,655 individuals in the UK CHIC cohort (2012 database). Costs of patented drugs were taken from the British National Formulary database, assuming a 30% discount. Costs of generic antiretrovirals were estimated using an 80% discount from patented prices, or actual costs where available. Two options were analysed: 1 - all patients use single-tablet regimens and patented versions of drugs; prices remain stable over time; 2 - all people switch from patented to generic drugs when available, after patent expiry (dates shown above). There were an estimated 67,000 people taking antiretrovirals in the UK in 2014, estimated to rise by 8% per year until 2018 (in line with previous rises). The most widely used antiretrovirals in the CHIC cohort were tenofovir (TDF) (75%), emtricitabine (FTC) (69%), efavirenz (EFV) (39%), lamivudine (3TC) (23%), abacavir (ABC) (18%), darunavir (DRV) (21%) and atazanavir (ATV) (16%). The predicted annual UK cost of generic ABC/3TC/EFV (three generic tablets once daily) was £1018 per person-year. Costs of patented single-tablet regimens ranged from £5000 to £7500 per person-year. Assuming continued use of patented antiretrovirals in the UK, the predicted total national costs of antiretroviral treatment were predicted to rise from £425 million in 2014 to £459 m in 2015, £495 m in 2016, £536 m in 2017 and £578 m in 2018. With a 100% switch to generics, total predicted costs were £337 m in 2014, £364 m in 2015, £382 m in 2016, £144 m in 2017 and £169 m in 2018. The total predicted saving over five years from a switch to generics was £1.1 billion. Systematic switching from patented to generic antiretrovirals could potentially save approximately £1.1 billion in the UK over the next five years, compared with continued use of patented versions: this money could be spent on urgently needed HIV prevention programmes. Similar savings are feasible for other European countries, given parallel patent expiry dates. More detailed economic evaluation is required to show when patented single-tablet regimens provide value for money, compared to bioequivalent generic versions of 3-4 pills once daily.
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Neilson, James R; Schwenzer, Birgit; Seshadri, Ram; Morse, Daniel E
2009-12-07
We report the synthesis and characterization of new structural variants of the isotypic compound with the generic chemical formula, Co(1-0.5x)(oct) Co(x)(tet) (OH)2 (Cl)x (H2O)n, all modifications of an alpha-Co(OH)2 lattice. We show that the occupancy of tetrahedrally coordinated cobalt sites and associated chloride ligands, x, is modulated by the rate of formation of the respective layered hydroxide salts from kinetically controlled aqueous hydrolysis at an air-water interface. This new level of structural control is uniquely enabled by the slow diffusion of a hydrolytic catalyst, a simple technique. Independent structural characterizations of the compounds separately describe various attributes of the materials on different length scales, revealing details hidden by the disordered average structures. The precise control over the population of distinct octahedrally and tetrahedrally coordinated cobalt ions in the lattice provides a gentle, generic method for modulating the coordination geometry of cobalt in the material without disturbing the lattice or using additional reagents. A mechanism is proposed to reconcile the observation of the kinetic control of the structure with competing interactions during the initial stages of hydrolysis and condensation.
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Lefmann, Kim; Klenø, Kaspar H; Birk, Jonas Okkels; Hansen, Britt R; Holm, Sonja L; Knudsen, Erik; Lieutenant, Klaus; von Moos, Lars; Sales, Morten; Willendrup, Peter K; Andersen, Ken H
2013-05-01
We here describe the result of simulations of 15 generic neutron instruments for the long-pulsed European Spallation Source. All instruments have been simulated for 20 different settings of the source time structure, corresponding to pulse lengths between 1 ms and 2 ms; and repetition frequencies between 10 Hz and 25 Hz. The relative change in performance with time structure is given for each instrument, and an unweighted average is calculated. The performance of the instrument suite is proportional to (a) the peak flux and (b) the duty cycle to a power of approximately 0.3. This information is an important input to determining the best accelerator parameters. In addition, we find that in our simple guide systems, most neutrons reaching the sample originate from the central 3-5 cm of the moderator. This result can be used as an input in later optimization of the moderator design. We discuss the relevance and validity of defining a single figure-of-merit for a full facility and compare with evaluations of the individual instrument classes.
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Distributed parameter modeling of repeated truss structures
NASA Technical Reports Server (NTRS)
Wang, Han-Ching
1994-01-01
A new approach to find homogeneous models for beam-like repeated flexible structures is proposed which conceptually involves two steps. The first step involves the approximation of 3-D non-homogeneous model by a 1-D periodic beam model. The structure is modeled as a 3-D non-homogeneous continuum. The displacement field is approximated by Taylor series expansion. Then, the cross sectional mass and stiffness matrices are obtained by energy equivalence using their additive properties. Due to the repeated nature of the flexible bodies, the mass, and stiffness matrices are also periodic. This procedure is systematic and requires less dynamics detail. The first step involves the homogenization from a 1-D periodic beam model to a 1-D homogeneous beam model. The periodic beam model is homogenized into an equivalent homogeneous beam model using the additive property of compliance along the generic axis. The major departure from previous approaches in literature is using compliance instead of stiffness in homogenization. An obvious justification is that the stiffness is additive at each cross section but not along the generic axis. The homogenized model preserves many properties of the original periodic model.
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Explore or Exploit? A Generic Model and an Exactly Solvable Case
NASA Astrophysics Data System (ADS)
Gueudré, Thomas; Dobrinevski, Alexander; Bouchaud, Jean-Philippe
2014-02-01
Finding a good compromise between the exploitation of known resources and the exploration of unknown, but potentially more profitable choices, is a general problem, which arises in many different scientific disciplines. We propose a stylized model for these exploration-exploitation situations, including population or economic growth, portfolio optimization, evolutionary dynamics, or the problem of optimal pinning of vortices or dislocations in disordered materials. We find the exact growth rate of this model for treelike geometries and prove the existence of an optimal migration rate in this case. Numerical simulations in the one-dimensional case confirm the generic existence of an optimum.
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Explore or exploit? A generic model and an exactly solvable case.
Gueudré, Thomas; Dobrinevski, Alexander; Bouchaud, Jean-Philippe
2014-02-07
Finding a good compromise between the exploitation of known resources and the exploration of unknown, but potentially more profitable choices, is a general problem, which arises in many different scientific disciplines. We propose a stylized model for these exploration-exploitation situations, including population or economic growth, portfolio optimization, evolutionary dynamics, or the problem of optimal pinning of vortices or dislocations in disordered materials. We find the exact growth rate of this model for treelike geometries and prove the existence of an optimal migration rate in this case. Numerical simulations in the one-dimensional case confirm the generic existence of an optimum.
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Structures and geriatrics from a failure analysis experience viewpoint
DOE Office of Scientific and Technical Information (OSTI.GOV)
Hopper, D.M.
In a failure analysis consulting engineering practice one sees a variety of structural failures from which observations may be made concerning geriatric structures. Representative experience with power plants, refineries, offshore structures, and forensic investigations is summarized and generic observations are made regarding the maintenance of fitness for purpose of structures. Although it is important to optimize the engineering design for a range of operational and environmental variables, it is essential that fabrication and inspection controls exist along with common sense based ongoing monitoring and operations procedures. 18 figs.
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Epidemic spreading on dual-structure networks with mobile agents
NASA Astrophysics Data System (ADS)
Yao, Yiyang; Zhou, Yinzuo
2017-02-01
The rapid development of modern society continually transforms the social structure which leads to an increasingly distinct dual structure of higher population density in urban areas and lower density in rural areas. Such structure may induce distinctive spreading behavior of epidemics which does not happen in a single type structure. In this paper, we study the epidemic spreading of mobile agents on dual structure networks based on SIRS model. First, beyond the well known epidemic threshold for generic epidemic model that when the infection rate is below the threshold a pertinent infectious disease will die out, we find the other epidemic threshold which appears when the infection rate of a disease is relatively high. This feature of two thresholds for the SIRS model may lead to the elimination of infectious disease when social network has either high population density or low population density. Interestingly, however, we find that when a high density area is connected to a low density may cause persistent spreading of the infectious disease, even though the same disease will die out when it spreads in each single area. This phenomenon indicates the critical role of the connection between the two areas which could radically change the behavior of spreading dynamics. Our findings, therefore, provide new understanding of epidemiology pertinent to the characteristic modern social structure and have potential to develop controlling strategies accordingly.
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High prices for generics in Australia - more competition might help.
Bulfone, Liliana
2009-05-01
It is commonly believed that dispensed prices of medicines in Australia are substantially lower than those in other developed countries, particularly the US. This article reports the results of an analysis comparing dispensed prices for the most commonly prescribed and the highest cost items in Australia with dispensed prices in the US. Although a large majority of items are less expensive in Australia than in the US, Australian prices are higher for a substantial number of products, particularly generic drugs. This article examines various policies affecting the pricing of generics in Australia. It is postulated that the main cause for higher prices for a substantial number of generic products is the lack of price competition. This results from government policy which ensures that a price reduction by one company is communicated immediately to all competitors in that market along with an invitation to match the reduced price. The dominant strategy for all suppliers is to only reduce their price in response to a reduction in price by a competitor. The result is a lack of differentiation in pricing across brands of a medicine on the Schedule of Pharmaceutical Benefits. The government could improve the structure of the generics market and encourage greater competition by ceasing to disclose competitor firms' offers to other competitors. The government could conduct pricing reviews of each generic product relatively infrequently (eg, only once annually or every 18 months). At the time of the pricing review, the government would request confidential offers on price for a generic from all players in the market. Brands should then all be listed under the Pharmaceutical Benefits Scheme (PBS) at the offered price. Prices offered by the individual supplier would apply until the next pricing review. The PBS would continue to subsidise up to the price of the lowest priced brand, with brand premiums applying to all brands priced higher than the benchmark price. Such an approach would provide opportunity for players in the market to capture market share by being the lowest priced brand.
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Development of a New Branded UK Food Composition Database for an Online Dietary Assessment Tool
Carter, Michelle C.; Hancock, Neil; Albar, Salwa A.; Brown, Helen; Greenwood, Darren C.; Hardie, Laura J.; Frost, Gary S.; Wark, Petra A.; Cade, Janet E.
2016-01-01
The current UK food composition tables are limited, containing ~3300 mostly generic food and drink items. To reflect the wide range of food products available to British consumers and to potentially improve accuracy of dietary assessment, a large UK specific electronic food composition database (FCDB) has been developed. A mapping exercise has been conducted that matched micronutrient data from generic food codes to “Back of Pack” data from branded food products using a semi-automated process. After cleaning and processing, version 1.0 of the new FCDB contains 40,274 generic and branded items with associated 120 macronutrient and micronutrient data and 5669 items with portion images. Over 50% of food and drink items were individually mapped to within 10% agreement with the generic food item for energy. Several quality checking procedures were applied after mapping including; identifying foods above and below the expected range for a particular nutrient within that food group and cross-checking the mapping of items such as concentrated and raw/dried products. The new electronic FCDB has substantially increased the size of the current, publically available, UK food tables. The FCDB has been incorporated into myfood24, a new fully automated online dietary assessment tool and, a smartphone application for weight loss. PMID:27527214
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Development of a New Branded UK Food Composition Database for an Online Dietary Assessment Tool.
Carter, Michelle C; Hancock, Neil; Albar, Salwa A; Brown, Helen; Greenwood, Darren C; Hardie, Laura J; Frost, Gary S; Wark, Petra A; Cade, Janet E
2016-08-05
The current UK food composition tables are limited, containing ~3300 mostly generic food and drink items. To reflect the wide range of food products available to British consumers and to potentially improve accuracy of dietary assessment, a large UK specific electronic food composition database (FCDB) has been developed. A mapping exercise has been conducted that matched micronutrient data from generic food codes to "Back of Pack" data from branded food products using a semi-automated process. After cleaning and processing, version 1.0 of the new FCDB contains 40,274 generic and branded items with associated 120 macronutrient and micronutrient data and 5669 items with portion images. Over 50% of food and drink items were individually mapped to within 10% agreement with the generic food item for energy. Several quality checking procedures were applied after mapping including; identifying foods above and below the expected range for a particular nutrient within that food group and cross-checking the mapping of items such as concentrated and raw/dried products. The new electronic FCDB has substantially increased the size of the current, publically available, UK food tables. The FCDB has been incorporated into myfood24, a new fully automated online dietary assessment tool and, a smartphone application for weight loss.
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Sousa, Caissa Veloso E; Mesquita, Jose Marcos Carvalho de; Lara, José Edson
2013-11-01
The scope of this study is to identify the factors that influence the consumer's decision when buying medicine. Prior to the Generics Act (Lei dos Genéricos), consumers had at their disposal two product purchase options in the private market, namely buying a reference drug and a similar one. Generic drugs are part of a public policy which was intended to broaden access to medication by the general population at more accessible costs, while maintaining the same quality as the reference drug, as ensured by bioequivalence tests from the national health surveillance agency ANVISA. Nevertheless, a question arises as to whether the potential consumer knows the difference between generic, similar and reference drugs, especially when taking into account the decision at the moment of purchase. In order to fulfill the proposed objective, a survey was conducted with 403 residents in Belo Horizonte, Brazil. The data gathered was tabulated and analyzed using factor analysis and crosstab. The results made it possible to infer that there is a strong predisposition among consumers to accept the suggestions of the pharmacists and/or salesman, and a significant portion of the population is confused at the moment of purchase.
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A LabVIEW® based generic CT scanner control software platform.
Dierick, M; Van Loo, D; Masschaele, B; Boone, M; Van Hoorebeke, L
2010-01-01
UGCT, the Centre for X-ray tomography at Ghent University (Belgium) does research on X-ray tomography and its applications. This includes the development and construction of state-of-the-art CT scanners for scientific research. Because these scanners are built for very different purposes they differ considerably in their physical implementations. However, they all share common principle functionality. In this context a generic software platform was developed using LabVIEW® in order to provide the same interface and functionality on all scanners. This article describes the concept and features of this software, and its potential for tomography in a research setting. The core concept is to rigorously separate the abstract operation of a CT scanner from its actual physical configuration. This separation is achieved by implementing a sender-listener architecture. The advantages are that the resulting software platform is generic, scalable, highly efficient, easy to develop and to extend, and that it can be deployed on future scanners with minimal effort.
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Nudging Leads Consumers In Colorado To Shop But Not Switch ACA Marketplace Plans.
Marzilli Ericson, Keith M; Kingsdale, Jon; Layton, Tim; Sacarny, Adam
2017-02-01
The Affordable Care Act (ACA) dramatically expanded the use of regulated marketplaces in health insurance, but consumers often fail to shop for plans during open enrollment periods. Typically these consumers are automatically reenrolled in their old plans, which potentially exposes them to unexpected increases in their insurance premiums and cost sharing. We conducted a randomized intervention to encourage enrollees in an ACA Marketplace to shop for plans. We tested the effect of letters and e-mails with personalized information about the savings on insurance premiums that they could realize from switching plans and the effect of generic communications that simply emphasized the possibility of saving. The personalized and generic messages both increased shopping on the Marketplace's website by 23 percent, but neither type of message had a significant effect on plan switching. These findings show that simple "nudges" with even generic information can promote shopping in health insurance marketplaces, but whether they can lead to switching remains an open question. Project HOPE—The People-to-People Health Foundation, Inc.
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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
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Petersen, Solveig; Hägglöf, Bruno; Stenlund, Hans; Bergström, Erik
2009-09-01
To study the psychometric performance of the Swedish version of the Pediatric Quality of Life Inventory (PedsQL) 4.0 generic core scales in a general child population in Sweden. PedsQL forms were distributed to 2403 schoolchildren and 888 parents in two different school settings. Reliability and validity was studied for self-reports and proxy reports, full forms and short forms. Confirmatory factor analysis tested the factor structure and multigroup confirmatory factor analysis tested measurement invariance between boys and girls. Test-retest reliability was demonstrated for all scales and internal consistency reliability was shown with alpha value exceeding 0.70 for all scales but one (self-report short form: social functioning). Child-parent agreement was low to moderate. The four-factor structure of the PedsQL and factorial invariance across sex subgroups were confirmed for the self-report forms and for the proxy short form, while model fit indices suggested improvement of several proxy full-form scales. The Swedish PedsQL 4.0 generic core scales are a reliable and valid tool for health-related quality of life (HRQoL) assessment in Swedish child populations. The proxy full form, however, should be used with caution. The study also support continued use of the PedsQL as a four-factor model, capable of revealing meaningful HRQoL differences between boys and girls.
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Limbers, Christine A; Newman, Daniel A; Varni, James W
2008-07-01
The objective of the present study was to examine the factorial invariance of the PedsQL 4.0 Generic Core Scales for child self-report across 11,433 children ages 5-18 with chronic health conditions and healthy children. Multigroup Confirmatory Factor Analysis was performed specifying a five-factor model. Two multigroup structural equation models, one with constrained parameters and the other with unconstrained parameters, were proposed in order to compare the factor loadings across children with chronic health conditions and healthy children. Metric invariance (i.e., equal factor loadings) was demonstrated based on stability of the Comparative Fit Index (CFI) between the two models, and several additional indices of practical fit including the root mean squared error of approximation, the Non-normed Fit Index, and the Parsimony Normed Fit Index. The findings support an equivalent five-factor structure on the PedsQL 4.0 Generic Core Scales across healthy and chronic health condition groups. These findings suggest that when differences are found across chronic health condition and healthy groups when utilizing the PedsQL, these differences are more likely real differences in self-perceived health-related quality of life, rather than differences in interpretation of the PedsQL items as a function of health status.
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Sadashiv, Mucheli Shravan; Rupali, Priscilla; Manesh, Abi; Kannangai, Rajesh; Abraham, Ooriapadickal Cherian; Pulimood, Susanne A; Karthik, Rajiv; Rajkumar, S; Thomas, Kurien
2017-12-01
Since the time of NACO Antiretroviral (ART) roll-out, generic ART has been the mainstay of therapy. There are many studies documenting the efficacy of generic ART but with the passage of time, failure of therapy is on the rise. As institution of second line ART has significant financial implications both for a program and for an individual it is imperative that we determine factors which contribute towards treatment failure in a cohort of patients on generic antiretroviral therapy. This was a nested matched case-control study assessing the predictors for treatment failure in our cohort who had been on Anti-retroviral therapy for at least a year. We identified 42 patients (Cases) with documented treatment failure out of our cohort of 823 patients and 42 sex, age and duration of therapy-matched controls. Using a structured proforma, we collected information from the out-patient and in-patient charts of the Infectious Diseases clinic Cohort in CMC, Vellore. A set of predetermined variables were studied as potential risk factors for treatment failure on ART. Univariate analysis showed significant association with 1) Self-reported nonadherence<95% [OR 12.81 (95%CI 1.54-281.45)]. 2) Treatment interruptions in adherent cases (OR 9.56 (95% CI 1.11-213.35)]. 3) Past inappropriate therapies [OR 9.65 (95% CI 1.12-215.94)]. 4) Diarrhoea [OR 16.40 (95% CI 2.02-3.55.960]. 5) GI opportunistic infections (OR 11.06 (95% CI 1.31 -244.27)] and 6) Drug Toxicity [OR 3.69 (95% CI 1.15-12.35).In multiple logistic regression analysis, we found independent risk factors of treatment failure to be: Self-reported non-adherence (<95%) with OR 15.46(95%CI 1.55 - 154.08), drug toxicity - OR 4.13(95%CI 1.095 - 15.534) and history of diarrhoea - OR 23.446(95%CI 2.572 - 213.70). This study reveals that besides adherence to therapy, presence of diarrhoea and occurrence of drug toxicity are significant risk factors associated with failure of anti-retroviral therapy. There is a need for further prospective studies to assess their role in development of treatment failure on ART and thus help development of targeted interventions.
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77 FR 28316 - Filing a Renewed License Application
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-14
... only those environmental impacts and alternatives that are reasonably foreseeable. This means that... action timeframe. With respect to assessing the potential future environmental impacts associated with... its consideration of impacts in the generic and supplemental environmental impact statements (SEISs...
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Wu, Eric Q; Yu, Andrew P; Lauzon, Veronique; Ramakrishnan, Karthik; Marynchenko, Maryna; Ben-Hamadi, Rym; Blum, Steven; Erder, M Haim
2011-04-01
To reduce pharmacy costs, managed care organizations encourage therapeutic substitution from brand to a generic product. However, little is known about whether these cost-containment strategies can also potentially lower total expenditures for payers in treatment of major depressive disorder (MDD). To compare economic outcomes of patients with MDD who were switched from a brand selective serotonin reuptake inhibitor (SSRI) to an alternative generic SSRI for nonmedical reasons versus patients who continued on the brand SSRI. Adult MDD patients in the Ingenix Impact Database (2003-2007) were considered "switchers" if they received treatment with a brand SSRI and were later switched to an alternative generic SSRI for nonmedical reasons. Patients who remained on the brand SSRI (nonswitchers) were matched 1:1 with switchers. All-cause, mental health-related, and MDD-related rates of hospitalizations/emergency department (ED) visits and costs over 6 months were compared both descriptively and by using adjusted regression models. A subgroup analysis on patients who were switched from escitalopram (Lexapro) to an alternative generic SSRI was also performed. The study included 4449 matched pairs. Compared with nonswitchers, switchers had higher risk of all-cause, mental health-related, and MDD-related use of hospitalizations/ED visits (OR 1.15, 1.34, and 1.54, respectively; all p < 0.01) and higher risk-adjusted mental health-related and MDD-related medical costs ($219 and $222, respectively; both p < 0.05). Subgroup analysis on escitalopram showed similar results; switchers experienced higher risk of any-cause, mental health-related, and MDD-related use of hospitalizations/ED visits (OR 1.21, 1.41, and 1.53, respectively; all p < 0.01) and higher risk-adjusted MDD-related medical costs ($151; p < 0.05). Compared with patients who continued on their patented SSRIs, patients who switched to a generic SSRI incurred more resource use of hospitalizations/ED visits and higher MDD-related health-care costs. The effects of therapeutic substitution should be carefully examined, because use of generic alternatives may not be a cost-saving strategy when total health-care costs are considered.
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Procter, T D; Pearl, D L; Finley, R L; Leonard, E K; Janecko, N; Reid-Smith, R J; Weese, J S; Peregrine, A S; Sargeant, J M
2014-06-01
Anti-microbial resistance can threaten health by limiting treatment options and increasing the risk of hospitalization and severity of infection. Companion animals can shed anti-microbial-resistant bacteria that may result in the exposure of other dogs and humans to anti-microbial-resistant genes. The prevalence of anti-microbial-resistant generic Escherichia coli in the faeces of dogs that visited dog parks in south-western Ontario was examined and risk factors for shedding anti-microbial-resistant generic E. coli identified. From May to August 2009, canine faecal samples were collected at ten dog parks in three cities in south-western Ontario, Canada. Owners completed a questionnaire related to pet characteristics and management factors including recent treatment with antibiotics. Faecal samples were collected from 251 dogs, and 189 surveys were completed. Generic E. coli was isolated from 237 of the faecal samples, and up to three isolates per sample were tested for anti-microbial susceptibility. Eighty-nine percent of isolates were pan-susceptible; 82.3% of dogs shed isolates that were pan-susceptible. Multiclass resistance was detected in 7.2% of the isolates from 10.1% of the dogs. Based on multilevel multivariable logistic regression, a risk factor for the shedding of generic E. coli resistant to ampicillin was attending dog day care. Risk factors for the shedding of E. coli resistant to at least one anti-microbial included attending dog day care and being a large mixed breed dog, whereas consumption of commercial dry and home cooked diets was protective factor. In a multilevel multivariable model for the shedding of multiclass-resistant E. coli, exposure to compost and being a large mixed breed dog were risk factors, while consumption of a commercial dry diet was a sparing factor. Pet dogs are a potential reservoir of anti-microbial-resistant generic E. coli; some dog characteristics and management factors are associated with the prevalence of anti-microbial-resistant generic E. coli in dogs. © 2013 Blackwell Verlag GmbH.
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Estimated costs of production and potential prices for the WHO Essential Medicines List
Hill, Andrew M; Barber, Melissa J
2018-01-01
Introduction There are persistent gaps in access to affordable medicines. The WHO Model List of Essential Medicines (EML) includes medicines considered necessary for functional health systems. Methods A generic price estimation formula was developed by reviewing published analyses of cost of production for medicines and assuming manufacture in India, which included costs of formulation, packaging, taxation and a 10% profit margin. Data on per-kilogram prices of active pharmaceutical ingredient exported from India were retrieved from an online database. Estimated prices were compared with the lowest globally available prices for HIV/AIDS, tuberculosis (TB) and malaria medicines, and current prices in the UK, South Africa and India. Results The estimation formula had good predictive accuracy for HIV/AIDS, TB and malaria medicines. Estimated generic prices ranged from US$0.01 to US$1.45 per unit, with most in the lower end of this range. Lowest available prices were greater than estimated generic prices for 214/277 (77%) comparable items in the UK, 142/212 (67%) in South Africa and 118/298 (40%) in India. Lowest available prices were more than three times above estimated generic price for 47% of cases compared in the UK and 22% in South Africa. Conclusion A wide range of medicines in the EML can be profitably manufactured at very low cost. Most EML medicines are sold in the UK and South Africa at prices significantly higher than those estimated from production costs. Generic price estimation and international price comparisons could empower government price negotiations and support cost-effectiveness calculations. PMID:29564159
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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.
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Generic Features of Tertiary Chromatin Structure as Detected in Natural Chromosomes
Müller, Waltraud G.; Rieder, Dietmar; Kreth, Gregor; Cremer, Christoph; Trajanoski, Zlatko; McNally, James G.
2004-01-01
Knowledge of tertiary chromatin structure in mammalian interphase chromosomes is largely derived from artificial tandem arrays. In these model systems, light microscope images reveal fibers or beaded fibers after high-density targeting of transactivators to insertional domains spanning several megabases. These images of fibers have lent support to chromonema fiber models of tertiary structure. To assess the relevance of these studies to natural mammalian chromatin, we identified two different ∼400-kb regions on human chromosomes 6 and 22 and then examined light microscope images of interphase tertiary chromatin structure when the regions were transcriptionally active and inactive. When transcriptionally active, these natural chromosomal regions elongated, yielding images characterized by a series of adjacent puncta or “beads”, referred to hereafter as beaded images. These elongated structures required transcription for their maintenance. Thus, despite marked differences in the density and the mode of transactivation, the natural and artificial systems showed similarities, suggesting that beaded images are generic features of transcriptionally active tertiary chromatin. We show here, however, that these images do not necessarily favor chromonema fiber models but can also be explained by a radial-loop model or even a simple nucleosome affinity, random-chain model. Thus, light microscope images of tertiary structure cannot distinguish among competing models, although they do impose key constraints: chromatin must be clustered to yield beaded images and then packaged within each cluster to enable decondensation into adjacent clusters. PMID:15485905
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Naimoli, Joseph F; Frymus, Diana E; Wuliji, Tana; Franco, Lynne M; Newsome, Martha H
2014-10-02
There has been a resurgence of interest in national Community Health Worker (CHW) programs in low- and middle-income countries (LMICs). A lack of strong research evidence persists, however, about the most efficient and effective strategies to ensure optimal, sustained performance of CHWs at scale. To facilitate learning and research to address this knowledge gap, the authors developed a generic CHW logic model that proposes a theoretical causal pathway to improved performance. The logic model draws upon available research and expert knowledge on CHWs in LMICs. Construction of the model entailed a multi-stage, inductive, two-year process. It began with the planning and implementation of a structured review of the existing research on community and health system support for enhanced CHW performance. It continued with a facilitated discussion of review findings with experts during a two-day consultation. The process culminated with the authors' review of consultation-generated documentation, additional analysis, and production of multiple iterations of the model. The generic CHW logic model posits that optimal CHW performance is a function of high quality CHW programming, which is reinforced, sustained, and brought to scale by robust, high-performing health and community systems, both of which mobilize inputs and put in place processes needed to fully achieve performance objectives. Multiple contextual factors can influence CHW programming, system functioning, and CHW performance. The model is a novel contribution to current thinking about CHWs. It places CHW performance at the center of the discussion about CHW programming, recognizes the strengths and limitations of discrete, targeted programs, and is comprehensive, reflecting the current state of both scientific and tacit knowledge about support for improving CHW performance. The model is also a practical tool that offers guidance for continuous learning about what works. Despite the model's limitations and several challenges in translating the potential for learning into tangible learning, the CHW generic logic model provides a solid basis for exploring and testing a causal pathway to improved performance.
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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
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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.
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Analysis of an industry in transition.
Baliga, B R; Johnson, B
1986-12-01
The health care industry is undergoing major structural changes. The significance of these changes for individual competitors moving toward the 1990s is not yet clear. This article assesses the implications of the current changes by applying Porter's industry structure and generic strategy frameworks to the health care industry. Present trends are compared to this analysis to highlight areas where individual hospitals might improve their competitive positioning.
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ERIC Educational Resources Information Center
Hou, Hsiao-I
2013-01-01
In this study, similarities and differences among generic structures in 80 cover letters written by Taiwanese and Canadian college students were investigated, adopting Upton and Connor's (2001) framework. The results demonstrated that Canadian students tend to write longer letters, use a greater variety of word types and sentence structures, and…
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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.
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Supergravity contributions to inflation in models with non-minimal coupling to gravity
DOE Office of Scientific and Technical Information (OSTI.GOV)
Das, Kumar; Dutta, Koushik; Domcke, Valerie, E-mail: kumar.das@saha.ac.in, E-mail: valerie.domcke@apc.univ-paris7.fr, E-mail: koushik.dutta@saha.ac.in
2017-03-01
This paper provides a systematic study of supergravity contributions relevant for inflationary model building in Jordan frame supergravity. In this framework, canonical kinetic terms in the Jordan frame result in the separation of the Jordan frame scalar potential into a tree-level term and a supergravity contribution which is potentially dangerous for sustaining inflation. We show that if the vacuum energy necessary for driving inflation originates dominantly from the F-term of an auxiliary field (i.e. not the inflaton), the supergravity corrections to the Jordan frame scalar potential are generically suppressed. Moreover, these supergravity contributions identically vanish if the superpotential vanishes alongmore » the inflationary trajectory. On the other hand, if the F-term associated with the inflaton dominates the vacuum energy, the supergravity contributions are generically comparable to the globally supersymmetric contributions. In addition, the non-minimal coupling to gravity inherent to Jordan frame supergravity significantly impacts the inflationary model depending on the size and sign of this coupling. We discuss the phenomenology of some representative inflationary models, and point out the relation to the recently much discussed cosmological 'attractor' models.« less
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Monk, Christopher T; Barbier, Matthieu; Romanczuk, Pawel; Watson, James R; Alós, Josep; Nakayama, Shinnosuke; Rubenstein, Daniel I; Levin, Simon A; Arlinghaus, Robert
2018-06-01
Understanding how humans and other animals behave in response to changes in their environments is vital for predicting population dynamics and the trajectory of coupled social-ecological systems. Here, we present a novel framework for identifying emergent social behaviours in foragers (including humans engaged in fishing or hunting) in predator-prey contexts based on the exploration difficulty and exploitation potential of a renewable natural resource. A qualitative framework is introduced that predicts when foragers should behave territorially, search collectively, act independently or switch among these states. To validate it, we derived quantitative predictions from two models of different structure: a generic mathematical model, and a lattice-based evolutionary model emphasising exploitation and exclusion costs. These models independently identified that the exploration difficulty and exploitation potential of the natural resource controls the social behaviour of resource exploiters. Our theoretical predictions were finally compared to a diverse set of empirical cases focusing on fisheries and aquatic organisms across a range of taxa, substantiating the framework's predictions. Understanding social behaviour for given social-ecological characteristics has important implications, particularly for the design of governance structures and regulations to move exploited systems, such as fisheries, towards sustainability. Our framework provides concrete steps in this direction. © 2018 John Wiley & Sons Ltd/CNRS.
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Estimating pesticide runoff in small streams.
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.
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Silverstein, M
1994-09-01
Twenty-one Occupational Safety and Health Act (OSHA) standards were identified which contain medical service provisions intended to help in the identification and control of harmful health effects of workplace exposures. The utility and effectiveness of these provisions have not previously been evaluated. All 21 standards were reviewed and assigned numerical scores for each of 24 potential medical program elements. Several of these elements were combined to calculate Quality Control, Screening Utility, and Surveillance Utility scores for each standard. Total scores varied greatly, suggesting a lack of consistency and uniformity which was even more obvious when the actual regulatory language was examined. The mean Quality score was only 26% of potential points. Seventeen of 21 standards received less than half the total possible Quality score. When arrayed on a two by two matrix only two standards scored above 50% for both Screening and Surveillance Utility. It was concluded that the medical service provisions in OSHA standards are lacking in consistency and coherence. Two major shortcomings are the lack of quality control elements and the absence of surveillance features which would permit medical program results to be utilized for prevention activities including the identification and control of workplace hazards. A generic occupational medical surveillance standard could address these current weaknesses. Elements of such a generic standard are proposed.
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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
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Contact centers, pervasive computing and telemedicine: a quality health care triangle.
Maglaveras, Nicos
2004-01-01
The Citizen Health System (CHS) is a European Commission (CEC) funded project in the field of IST for Health. Its main goal is to develop a generic contact center which in its pilot stage can be used in the monitoring, treatment and management of chronically ill patients at home in Greece, Spain, and Germany. Such contact centers, using any type of communication technology, and providing timely and preventive prompting to the patients are envisaged in the future to evolve into well-being contact centers providing services to all citizens. In this paper, we present the structure of such a generic contact center and present its major achievements, and their impact to the quality of health delivery.
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NASA Astrophysics Data System (ADS)
Jänig, A.
2018-05-01
We consider asymptotically autonomous semilinear parabolic equations u_t + Au = f(t,u). Suppose that $f(t,.)\\to f^\\pm$ as $t\\to\\pm\\infty$, where the semiflows induced by \\label{eq:140602-1511} u_t + Au = f^\\pm(u) \\tag{*} are gradient-like. Under certain assumptions, it is shown that generically with respect to a perturbation $g$ with $g(t)\\to 0$ as $|t|\\to\\infty$, every solution of u_t + Au = f(t,u) + g(t) is a connection between equilibria $e^\\pm$ of \\eqref{eq:140602-1511} with $m(e^-)\\geq m(e^+)$. Moreover, if the Morse indices satisfy $m(e^-) = m(e^+)$, then $u$ is isolated by linearization.
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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.
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Generic versus brand-name drugs used in cardiovascular diseases.
Manzoli, Lamberto; Flacco, Maria Elena; Boccia, Stefania; D'Andrea, Elvira; Panic, Nikola; Marzuillo, Carolina; Siliquini, Roberta; Ricciardi, Walter; Villari, Paolo; Ioannidis, John P A
2016-04-01
This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov (last update December 1, 2014). Attempts were made to contact the investigators of all potentially eligible trials. Two investigators independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. We included 74 randomized trials; 53 reported ≥1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 51 evaluated serious adverse events (n = 2892). We included trials assessing ACE inhibitors (n = 12), anticoagulants (n = 5), antiplatelet agents (n = 17), beta-blockers (n = 11), calcium channel blockers (n = 7); diuretics (n = 13); statins (n = 6); and others (n = 3). For both soft and hard efficacy outcomes, 100 % of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95 % CI -0.05; 0.08) for soft outcomes; -0.06 (-0.71; 0.59) for hard outcomes. All but two trials showed non-significant differences in mild/moderate adverse events, and aggregate effect size was 0.07 (-0.06; 0.20). Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5/2074 subjects on generics; 3/2076 subjects on brand-name drugs (OR 1.69; 95 % CI 0.40-7.20). This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider use.
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Assessment of industrial attitudes toward generic research needs in tribology
DOE Office of Scientific and Technical Information (OSTI.GOV)
Sibley, L.B.; Zlotnick, M.; Levinson, T.M.
Based on extended discussions during visits with 27 companies representing 13 different parts of the tribology industry (such as bearings, lubricants, coatings, powerplants), it is apparent that only a tiny fraction of the large sums publicly reported as R and D expenditures by industry are used to fund generic tribology research. For example, of the greater than $2 B expenditures reported for R and D in the lubricants sector for 1982, the estimated total for generic tribology research was $12 M. This was the largest expenditure in any sector of the tribology industry and one-third of the total of $36more » M. In the automotive industry out of a reported expenditure of $4 B, the estimated generic tribology research was $3 M. In some segments of the tribology industry, for example coatings and filters, there were no expenditures on generic research. There was little tendency to improve the state of the art of the tribology industry through long-term investment in generic R and D in ways that would foster innovation and productivity of energy conservation technology. Expenditures were oriented to development of specific commercial and military products, or to basic research focused on unspecified far term results, although useful spin-off of military developments into commercial fields sometimes occurs. There was a broad consensus in the companies visited that existing research results were not always made easily accessible to potential users in industry. The implication was that industry might benefit more if a larger fraction of the funds were devoted to putting the research results into a form design and development engineers could more readily apply. The need for a more effective presentation of research results was expressed with greater urgency at the smaller companies, but there seemed to be a broad consensus on the need for improvement. Recommendations are given.« less
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EVALUATION OF A GENERIC ARRAY APPROACH FOR GENOTYPING NOROVIRUSES
Noroviruses are the leading cause of nonbacterial gastroenteritis outbreaks in the United States. Because of their potential to contaminate drinking water, the U.S Environmental Protection Agency has included noroviruses on the Contaminant Candidate List (CCL) to assess the publi...
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Liu, Yan-Chun; Xiao, Sa; Yang, Kun; Ling, Li; Sun, Zhi-Liang; Liu, Zhao-Ying
2017-06-01
This study reports an applicable analytical strategy of comprehensive identification and structure characterization of target components from Gelsemium elegans by using high-performance liquid chromatography quadrupole time-of-flight mass spectrometry (LC-QqTOF MS) based on the use of accurate mass databases combined with MS/MS spectra. The databases created included accurate masses and elemental compositions of 204 components from Gelsemium and their structural data. The accurate MS and MS/MS spectra were acquired through data-dependent auto MS/MS mode followed by an extraction of the potential compounds from the LC-QqTOF MS raw data of the sample. The same was matched using the databases to search for targeted components in the sample. The structures for detected components were tentatively characterized by manually interpreting the accurate MS/MS spectra for the first time. A total of 57 components have been successfully detected and structurally characterized from the crude extracts of G. elegans, but has failed to differentiate some isomers. This analytical strategy is generic and efficient, avoids isolation and purification procedures, enables a comprehensive structure characterization of target components of Gelsemium and would be widely applicable for complicated mixtures that are derived from Gelsemium preparations. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.
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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
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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.
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Overcoming barriers to membrane protein structure determination.
Bill, Roslyn M; Henderson, Peter J F; Iwata, So; Kunji, Edmund R S; Michel, Hartmut; Neutze, Richard; Newstead, Simon; Poolman, Bert; Tate, Christopher G; Vogel, Horst
2011-04-01
After decades of slow progress, the pace of research on membrane protein structures is beginning to quicken thanks to various improvements in technology, including protein engineering and microfocus X-ray diffraction. Here we review these developments and, where possible, highlight generic new approaches to solving membrane protein structures based on recent technological advances. Rational approaches to overcoming the bottlenecks in the field are urgently required as membrane proteins, which typically comprise ~30% of the proteomes of organisms, are dramatically under-represented in the structural database of the Protein Data Bank.
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Generics, Supergenerics and Patent Strategies--SMi's 13th Annual Meeting.
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.
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Triangulation and the importance of establishing valid methods for food safety culture evaluation.
Jespersen, Lone; Wallace, Carol A
2017-10-01
The research evaluates maturity of food safety culture in five multi-national food companies using method triangulation, specifically self-assessment scale, performance documents, and semi-structured interviews. Weaknesses associated with each individual method are known but there are few studies in food safety where a method triangulation approach is used for both data collection and data analysis. Significantly, this research shows that individual results taken in isolation can lead to wrong conclusions, resulting in potentially failing tactics and wasted investments. However, by applying method triangulation and reviewing results from a range of culture measurement tools it is possible to better direct investments and interventions. The findings add to the food safety culture paradigm beyond a single evaluation of food safety culture using generic culture surveys. Copyright © 2017. Published by Elsevier Ltd.
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A Pan-GTPase Inhibitor as a Molecular Probe
Hong, Lin; Guo, Yuna; BasuRay, Soumik; Agola, Jacob O.; Romero, Elsa; Simpson, Denise S.; Schroeder, Chad E.; Simons, Peter; Waller, Anna; Garcia, Matthew; Carter, Mark; Ursu, Oleg; Gouveia, Kristine; Golden, Jennifer E.; Aubé, Jeffrey; Wandinger-Ness, Angela; Sklar, Larry A.
2015-01-01
Overactive GTPases have often been linked to human diseases. The available inhibitors are limited and have not progressed far in clinical trials. We report here a first-in-class small molecule pan-GTPase inhibitor discovered from a high throughput screening campaign. The compound CID1067700 inhibits multiple GTPases in biochemical, cellular protein and protein interaction, as well as cellular functional assays. In the biochemical and protein interaction assays, representative GTPases from Rho, Ras, and Rab, the three most generic subfamilies of the GTPases, were probed, while in the functional assays, physiological processes regulated by each of the three subfamilies of the GTPases were examined. The chemical functionalities essential for the activity of the compound were identified through structural derivatization. The compound is validated as a useful molecular probe upon which GTPase-targeting inhibitors with drug potentials might be developed. PMID:26247207
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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.
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The home hemodialysis hub: physical infrastructure and integrated governance structure.
Marshall, Mark R; Young, Bessie A; Fox, Sally J; Cleland, Calli J; Walker, Robert J; Masakane, Ikuto; Herold, Aaron M
2015-04-01
An effective home hemodialysis program critically depends on adequate hub facilities and support functions and on transparent and accountable organizational processes. The likelihood of optimal service delivery and patient care will be enhanced by fit-for-purpose facilities and implementation of a well-considered governance structure. In this article, we describe the required accommodation and infrastructure for a home hemodialysis program and a generic organizational structure that will support both patient-facing clinical activities and business processes. © 2015 International Society for Hemodialysis.
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Characterization of an acoustic cavitation bubble structure at 230 kHz.
Thiemann, Andrea; Nowak, Till; Mettin, Robert; Holsteyns, Frank; Lippert, Alexander
2011-03-01
A generic bubble structure in a 230 kHz ultrasonic field is observed in a partly developed standing wave field in water. It is characterized by high-speed imaging, sonoluminescence recordings, and surface cleaning tests. The structure has two distinct bubble populations. Bigger bubbles (much larger than linear resonance size) group on rings in planes parallel to the transducer surface, apparently in locations of driving pressure minima. They slowly rise in a jittering, but synchronous way, and they can have smaller satellite bubbles, thus resembling the arrays of bubbles observed by Miller [D. Miller, Stable arrays of resonant bubbles in a 1-MHz standing-wave acoustic field, J. Acoust. Soc. Am. 62 (1977) 12]. Smaller bubbles (below and near linear resonance size) show a fast "streamer" motion perpendicular to and away from the transducer surface. While the bigger bubbles do not emit light, the smaller bubbles in the streamers show sonoluminescence when they pass the planes of high driving pressure. Both bubble populations exhibit cleaning potential with respect to micro-particles attached to a glass substrate. The respective mechanisms of particle removal, though, might be different. Copyright © 2010 Elsevier B.V. All rights reserved.
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Measuring Belief in Conspiracy Theories: The Generic Conspiracist Beliefs Scale
Brotherton, Robert; French, Christopher C.; Pickering, Alan D.
2013-01-01
The psychology of conspiracy theory beliefs is not yet well understood, although research indicates that there are stable individual differences in conspiracist ideation – individuals’ general tendency to engage with conspiracy theories. Researchers have created several short self-report measures of conspiracist ideation. These measures largely consist of items referring to an assortment of prominent conspiracy theories regarding specific real-world events. However, these instruments have not been psychometrically validated, and this assessment approach suffers from practical and theoretical limitations. Therefore, we present the Generic Conspiracist Beliefs (GCB) scale: a novel measure of individual differences in generic conspiracist ideation. The scale was developed and validated across four studies. In Study 1, exploratory factor analysis of a novel 75-item measure of non-event-based conspiracist beliefs identified five conspiracist facets. The 15-item GCB scale was developed to sample from each of these themes. Studies 2, 3, and 4 examined the structure and validity of the GCB, demonstrating internal reliability, content, criterion-related, convergent and discriminant validity, and good test-retest reliability. In sum, this research indicates that the GCB is a psychometrically sound and practically useful measure of conspiracist ideation, and the findings add to our theoretical understanding of conspiracist ideation as a monological belief system unpinned by a relatively small number of generic assumptions about the typicality of conspiratorial activity in the world. PMID:23734136
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Ferlie, Ewan; Crilly, Tessa; Jashapara, Ashok; Peckham, Anna
2012-04-01
The health policy domain has displayed increasing interest in questions of knowledge management and knowledge mobilisation within healthcare organisations. We analyse here the findings of a critical review of generic management and health-related literatures, covering the period 2000-2008. Using 29 pre-selected journals, supplemented by a search of selected electronic databases, we map twelve substantive domains classified into four broad groups: taxonomic and philosophical (e.g. different types of knowledge); theoretical discourse (e.g. critical organisational studies); disciplinary fields (e.g. organisational learning and Information Systems/Information Technology); and organisational processes and structures (e.g. organisational form). We explore cross-overs and gaps between these traditionally separate literature streams. We found that health sector literature has absorbed some generic concepts, notably Communities of Practice, but has not yet deployed the performance-oriented perspective of the Resource Based View (RBV) of the Firm. The generic literature uses healthcare sites to develop critical analyses of power and control in knowledge management, rooted in neo-Marxist/labour process and Foucauldian approaches. The review generates three theoretically grounded statements to inform future enquiry, by: (a) importing the RBV stream; (b) developing the critical organisational studies perspective further; and (c) exploring the theoretical argument that networks and other alternative organisational forms facilitate knowledge sharing. Copyright © 2012 Elsevier Ltd. All rights reserved.
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Protein particulates: another generic form of protein aggregation?
Krebs, Mark R H; Devlin, Glyn L; Donald, A M
2007-02-15
Protein aggregation is a problem with a multitude of consequences, ranging from affecting protein expression to its implication in many diseases. Of recent interest is the specific form of aggregation leading to the formation of amyloid fibrils, structures associated with diseases such as Alzheimer's disease. The ability to form amyloid fibrils is now regarded as a property generic to all polypeptide chains. Here we show that around the isoelectric point a different generic form of aggregation can also occur by studying seven widely different, nonrelated proteins that are also all known to form amyloid fibrils. Under these conditions gels consisting of relatively monodisperse spherical particulates are formed. Although these gels have been described before for beta-lactoglobulin, our results suggest that the formation of particulates in the regime where charge on the molecules is minimal is a common property of all proteins. Because the proteins used here also form amyloid fibrils, we further propose that protein misfolding into clearly defined aggregates is a generic process whose outcome depends solely on the general properties of the state the protein is in when aggregation occurs, rather than the specific amino acid sequence. Thus under conditions of high net charge, amyloid fibrils form, whereas under conditions of low net charge, particulates form. This observation furthermore suggests that the rules of soft matter physics apply to these systems.
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Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.
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.
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Transforming RN education: clinical learning and clinical knowledge development.
Benner, P
1993-04-01
Transforming RN education has the potential for transforming clinical teaching and learning for all students. The returning RN student offers possibilities for clinical learning that the generic student does not have, but this should not cause us to limit the returning RN student to the generic level. Where possible innovative programs should be developed to move the RN student from baccalaureate level to the Master's level. As educators, we should take the opportunity to increase the numbers of nurses who are educationally prepared to move into advanced levels of practice. The returning RN student offers a rich human resource for the profession, and a rich resource for improving our clinical teaching as well as our practice.
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Plateau inflation from random non-minimal coupling
DOE Office of Scientific and Technical Information (OSTI.GOV)
Broy, Benedict J.; Coone, Dries; Theoretische Natuurkunde,Vrije Universiteit Brussel and The International Solvay Institutes,Pleinlaan 2, B-1050 Brussels
A generic non-minimal coupling can push any higher-order terms of the scalar potential sufficiently far out in field space to yield observationally viable plateau inflation. We provide analytic and numerical evidence that this generically happens for a non-minimal coupling strength ξ of the order N{sub e}{sup 2}. In this regime, the non-minimally coupled field is sub-Planckian during inflation and is thus protected from most higher-order terms. For larger values of ξ, the inflationary predictions converge towards the sweet spot of PLANCK. The latter includes ξ≃10{sup 4} obtained from CMB normalization arguments, thus providing a natural explanation for the inflationary observablesmore » measured.« less
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Encouraging generic use can yield significant savings.
Zimmerman, Christina
2012-11-01
Key findings. (1) Zero copayment for generic drugs is the greatest influencer of generic statin utilization. (2) Both higher copayments for generic drugs and lower copayments for competing brands are associated with a decreased probability of using generic statins. (3) Prior authorization and step therapy requirements for brand-name statins are associated with an increased use of generic drugs. (4) Greater use of generic statins should reduce costs for patients, plans, and Medicare.
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Escobar, Antonio; Trujillo-Martín, Maria del Mar; Rueda, Antonio; Pérez-Ruiz, Elisabeth; Avis, Nancy E; Bilbao, Amaia
2015-11-16
The aim of this study was to validate the Quality of Life in Adult Cancer Survivors (QLACS) in short-term Spanish cancer survivor's patients. Patients with breast, colorectal or prostate cancer that had finished their initial cancer treatment 3 years before the beginning of this study completed QLACS, WHOQOL, Short Form-36, Hospital Anxiety and Depression Scale, EORTC-QLQ-BR23 and EQ-5D. Cultural adaptation was made based on established guidelines. Reliability was evaluated using internal consistency and test-retest. Convergent validity was studied by mean of Pearson's correlation coefficient. Structural validity was determined by a second-order confirmatory factor analysis (CFA) and Rasch analysis was used to assess the unidimensionality of the Generic and Cancer-specific scales. Cronbach's alpha were above 0.7 in all domains and summary scales. Test-retest coefficients were 0.88 for Generic and 0.82 for Cancer-specific summary scales. QLACS generic summary scale was correlated with other generic criterion measures, SF-36 MCS (r = - 0.74) and EQ-VAS (r = - 0.63). QLACS cancer-specific scale had lower values with the same constructs. CFA provided satisfactory fit indices in all cases. The RMSEA value was 0.061 and CFI and TLI values were 0.929 and 0.925, respectively. All factor loadings were higher than 0.40 and statistically significant (P < 0.001). Generic summary scale had eight misfitting items. In the remaining 20 items, the unidimensionality was supported. Cancer Specific summary scale showed four misfitting items, the remaining showed unidimensionality. The findings support the validity and reliability of QLACS questionnaire to be used in short-term cancer survivors.
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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...
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Generic drugs in Brazil: known by many, used by few.
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.
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Generic concept to program the time domain of self-assemblies with a self-regulation mechanism.
Heuser, Thomas; Steppert, Ann-Kathrin; Lopez, Catalina Molano; Zhu, Baolei; Walther, Andreas
2015-04-08
Nature regulates complex structures in space and time via feedback loops, kinetically controlled transformations, and under energy dissipation to allow non-equilibrium processes. Although man-made static self-assemblies realize excellent control over hierarchical structures via molecular programming, managing their temporal destiny by self-regulation is a largely unsolved challenge. Herein, we introduce a generic concept to control the time domain by programming the lifetimes of switchable self-assemblies in closed systems. We conceive dormant deactivators that, in combination with fast promoters, enable a unique kinetic balance to establish an autonomously self-regulating, transient pH-state, whose duration can be programmed over orders of magnitude-from minutes to days. Coupling this non-equilibrium state to pH-switchable self-assemblies allows predicting their assembly/disassembly fate in time, similar to a precise self-destruction mechanism. We demonstrate a platform approach by programming self-assembly lifetimes of block copolymers, nanoparticles, and peptides, enabling dynamic materials with a self-regulation functionality.
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Locking mechanisms in degree-4 vertex origami structures
NASA Astrophysics Data System (ADS)
Fang, Hongbin; Li, Suyi; Xu, Jian; Wang, K. W.
2016-04-01
Origami has emerged as a potential tool for the design of mechanical metamaterials and metastructures whose novel properties originate from their crease patterns. Most of the attention in origami engineering has focused on the wellknown Miura-Ori, a folded tessellation that is flat-foldable for folded sheet and stacked blocks. This study advances the state of the art and expands the research field to investigate generic degree-4 vertex (4-vertex) origami, with a focus on facet-binding. In order to understand how facet-binding attributes to the mechanical properties of 4-vertex origami structures, geometries of the 4-vertex origami cells are analyzed and analytically expressed. Through repeating and stacking 4-vertex cells, origami sheets and stacked origami blocks can be constructed. Geometry analyses discover four mechanisms that will lead to the self-locking of 4-vertex origami cells, sheets, and stacked blocks: in-cell facet-binding, inlayer facet-binding, inter-layer facet binding, and in-layer and inter-layer facet-bindings. These mechanisms and the predicted self-locking phenomena are verified through 3D simulations and prototype experiments. Finally, this paper briefly introduces the unusual mechanical properties caused by the locking of 4-vertex origami structures. The research reported in this paper could foster a new breed of self-locking structures with various engineering applications.
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Garcia-Pardo, Javier; Graña-Montes, Ricardo; Fernandez-Mendez, Marc; Ruyra, Angels; Roher, Nerea; Aviles, Francesc X.; Lorenzo, Julia; Ventura, Salvador
2014-01-01
Protein aggregation is linked to a growing list of diseases, but it is also an intrinsic property of polypeptides, because the formation of functional globular proteins comes at the expense of an inherent aggregation propensity. Certain proteins can access aggregation-prone states from native-like conformations without the need to cross the energy barrier for unfolding. This is the case of transthyretin (TTR), a homotetrameric protein whose dissociation into its monomers initiates the aggregation cascade. Domains with structural homology to TTR exist in a number of proteins, including the M14B subfamily carboxypeptidases. We show here that the monomeric transthyretin-like domain of human carboxypeptidase D aggregates under close to physiological conditions into amyloid structures, with the population of folded but aggregation-prone states being controlled by the conformational stability of the domain. We thus confirm that the TTR fold keeps a generic residual aggregation propensity upon folding, resulting from the presence of preformed amyloidogenic β-strands in the native state. These structural elements should serve for functional/structural purposes, because they have not been purged out by evolution, but at the same time they put proteins like carboxypeptidase D at risk of aggregation in biological environments and thus can potentially lead to deposition diseases. PMID:25294878
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Danansuriya, Manjula Nishanthi; Rajapaksa, Lalini C
2012-09-04
The concept Health related Quality of life (HRQOL) is increasingly recognized as an important health outcome measure in clinical and research fields. The present study attempted to evaluate the psychometric properties of the Sinhala version of the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ 4.0) Generic Core Scales among adolescents in Sri Lanka. The original US PedsQL™ was translated into Sinhala and conceptually validated according to international guidelines. A cross-sectional study was conducted among 142 healthy school going adolescents (12-14 years), their parents (n = 120) and a group of adolescents with asthma who attended asthma clinics (n = 115). Reliability was assessed using Cronbach's alpha and validity by examining scale structure, exploring inter-scale correlations and comparing across known groups (healthy vs. chronically ill). The PedsQL™ Sinhala version was found to be acceptable with minimal missing responses. All scales demonstrated satisfactory reliability. Cronbach's alpha for the total scale scores was 0.85 for adolescent self-report while for the parent proxy-report for the healthy group it was 0.86. No floor effects were observed. Ceiling effects were noticed in self-report and parent proxy-report for the healthy group. Overall results of the multi trait scaling analysis confirmed the scale structure with 74% item-convergent validity, 88% item-discriminant validity and an overall scaling success of 72%. Moderate to high correlations were shown among the domains of teen self-report (Spearman rho = .37-.54) and between teen self-report and parent proxy-reports (Spearman rho = .41-.57). The PedsQL™ tool was able to discriminate between the quality of life in healthy adolescents and adolescents with asthma. The findings support the reliability and validity of the Sinhala version of the PedsQL™ 4.0 Generic Core Scales as a generic instrument to measure HRQOL among early adolescents in Sri Lanka in a population setting.
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Knowledge, perceptions and use of generic drugs: a cross sectional study
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
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What use is generic prescribing?
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
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A Generic Inner-Loop Control Law Structure for Six-Degree-of-Freedom Conceptual Aircraft Design
NASA Technical Reports Server (NTRS)
Cox, Timothy H.; Cotting, M. Christopher
2005-01-01
A generic control system framework for both real-time and batch six-degree-of-freedom simulations is presented. This framework uses a simplified dynamic inversion technique to allow for stabilization and control of any type of aircraft at the pilot interface level. The simulation, designed primarily for the real-time simulation environment, also can be run in a batch mode through a simple guidance interface. Direct vehicle-state acceleration feedback is required with the simplified dynamic inversion technique. The estimation of surface effectiveness within real-time simulation timing constraints also is required. The generic framework provides easily modifiable control variables, allowing flexibility in the variables that the pilot commands. A direct control allocation scheme is used to command aircraft effectors. Primary uses for this system include conceptual and preliminary design of aircraft, when vehicle models are rapidly changing and knowledge of vehicle six-degree-of-freedom performance is required. A simulated airbreathing hypersonic vehicle and simulated high-performance fighter aircraft are used to demonstrate the flexibility and utility of the control system.
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A Generic Inner-Loop Control Law Structure for Six-Degree-of-Freedom Conceptual Aircraft Design
NASA Technical Reports Server (NTRS)
Cox, Timothy H.; Cotting, Christopher
2005-01-01
A generic control system framework for both real-time and batch six-degree-of-freedom (6-DOF) simulations is presented. This framework uses a simplified dynamic inversion technique to allow for stabilization and control of any type of aircraft at the pilot interface level. The simulation, designed primarily for the real-time simulation environment, also can be run in a batch mode through a simple guidance interface. Direct vehicle-state acceleration feedback is required with the simplified dynamic inversion technique. The estimation of surface effectiveness within real-time simulation timing constraints also is required. The generic framework provides easily modifiable control variables, allowing flexibility in the variables that the pilot commands. A direct control allocation scheme is used to command aircraft effectors. Primary uses for this system include conceptual and preliminary design of aircraft, when vehicle models are rapidly changing and knowledge of vehicle 6-DOF performance is required. A simulated airbreathing hypersonic vehicle and simulated high-performance fighter aircraft are used to demonstrate the flexibility and utility of the control system.
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Generic, scalable and decentralized fault detection for robot swarms.
Tarapore, Danesh; Christensen, Anders Lyhne; Timmis, Jon
2017-01-01
Robot swarms are large-scale multirobot systems with decentralized control which means that each robot acts based only on local perception and on local coordination with neighboring robots. The decentralized approach to control confers number of potential benefits. In particular, inherent scalability and robustness are often highlighted as key distinguishing features of robot swarms compared with systems that rely on traditional approaches to multirobot coordination. It has, however, been shown that swarm robotics systems are not always fault tolerant. To realize the robustness potential of robot swarms, it is thus essential to give systems the capacity to actively detect and accommodate faults. In this paper, we present a generic fault-detection system for robot swarms. We show how robots with limited and imperfect sensing capabilities are able to observe and classify the behavior of one another. In order to achieve this, the underlying classifier is an immune system-inspired algorithm that learns to distinguish between normal behavior and abnormal behavior online. Through a series of experiments, we systematically assess the performance of our approach in a detailed simulation environment. In particular, we analyze our system's capacity to correctly detect robots with faults, false positive rates, performance in a foraging task in which each robot exhibits a composite behavior, and performance under perturbations of the task environment. Results show that our generic fault-detection system is robust, that it is able to detect faults in a timely manner, and that it achieves a low false positive rate. The developed fault-detection system has the potential to enable long-term autonomy for robust multirobot systems, thus increasing the usefulness of robots for a diverse repertoire of upcoming applications in the area of distributed intelligent automation.
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Generic, scalable and decentralized fault detection for robot swarms
Christensen, Anders Lyhne; Timmis, Jon
2017-01-01
Robot swarms are large-scale multirobot systems with decentralized control which means that each robot acts based only on local perception and on local coordination with neighboring robots. The decentralized approach to control confers number of potential benefits. In particular, inherent scalability and robustness are often highlighted as key distinguishing features of robot swarms compared with systems that rely on traditional approaches to multirobot coordination. It has, however, been shown that swarm robotics systems are not always fault tolerant. To realize the robustness potential of robot swarms, it is thus essential to give systems the capacity to actively detect and accommodate faults. In this paper, we present a generic fault-detection system for robot swarms. We show how robots with limited and imperfect sensing capabilities are able to observe and classify the behavior of one another. In order to achieve this, the underlying classifier is an immune system-inspired algorithm that learns to distinguish between normal behavior and abnormal behavior online. Through a series of experiments, we systematically assess the performance of our approach in a detailed simulation environment. In particular, we analyze our system’s capacity to correctly detect robots with faults, false positive rates, performance in a foraging task in which each robot exhibits a composite behavior, and performance under perturbations of the task environment. Results show that our generic fault-detection system is robust, that it is able to detect faults in a timely manner, and that it achieves a low false positive rate. The developed fault-detection system has the potential to enable long-term autonomy for robust multirobot systems, thus increasing the usefulness of robots for a diverse repertoire of upcoming applications in the area of distributed intelligent automation. PMID:28806756
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Follow-on biologics: competition in the biopharmaceutical marketplace.
Devine, Joshua W; Cline, Richard R; Farley, Joel F
2006-01-01
To describe the implications of a follow-on biologic approval process with focus on current stakeholders, implications of the status quo, and recommendations for future policy. A search using Medline, International Pharmaceutical Abstracts, Med Ad News, F-D-C Reports/Pink Sheets, and Google index directories was conducted with terms such as biologic, biopharmaceutical, generic, and follow-on. Articles pertaining to the follow-on biologic debate. By the authors. Over the past decade, the biopharmaceutical market has experienced substantial growth in the number of product approvals and sales. In contrast with prescription medications, biologic agents currently lack an abbreviated regulatory approval process. Evidence from the Drug Price Competition and Patent Term Restoration Act of 1984 suggests that reducing barriers to generic competition in the pharmaceutical market successfully increases generic market penetration and reduces overall prices to consumers. Although scientific and regulatory dissimilarities between biopharmaceuticals and other medications exist, a follow-on biologic approval process has the potential to play an important role in containing growth in pharmaceutical spending. In addition to biopharmaceutical and generic biopharmaceutical manufacturers, stakeholders with a vested interest in this debate include individual consumers who continue to bear the burden of spending increases in the pharmaceutical market. The debate over a follow-on process likely will be difficult as parties seek a balance between incentives for biopharmaceutical innovation, consumer safety, and affordability of existing biologic products.
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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.
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Impact of medicare part D plan features on use of generic drugs.
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.
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Do higher-priced generic medicines enjoy a competitive advantage under reference pricing?
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.
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Questionnaire on the awareness of generic drugs among outpatients and medical staff.
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.
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Fraeyman, J; Van Hal, G; De Loof, H; Remmen, R; De Meyer, G R Y; Beutels, P
2012-01-01
Pharmaceutical expenditures are increasing as a proportion of health expenditures in most rich countries. Antidepressants, acid blocking agents and cholesterol lowering medication are major contributors to medicine sales around the globe. We aimed to document the possible impact of policy regulations and generic market penetration on the evolution of sales volume and average cost per unit (Defined Daily Doses and packages) of antidepressants, acid blocking agents and cholesterol lowering medication. We extracted data from the IMS health database regarding the public price and sales volume of the antidepressants (selective serotonin reuptake inhibitors (SSRI's), monoamine oxidase inhibitors (MAOl's) and tricyclic and remaining antidepressants (TCA's)), acid blocking agents (proton pump inhibitors (PPl's) and H2 receptor antagonists) and cholesterol lowering medication (statins and fibrates) in Belgium between 1995 and 2009. We describe these sales data in relation to various national policy measures which were systematically searched in official records. Our analysis suggests that particular policy regulations have had immediate impact on sales figures and expenditures on pharmaceuticals in Belgium: changes in reimbursement conditions, a public tender and entry of generic competitors in a reference pricing system. However, possible sustainable effects seem to be counteracted by other mechanisms such as marketing strategies, prescribing behaviour, brand loyalty and the entry of pseudogenerics. It is likely that demand-side measures have a more sustainable impact on expenditure. Compared with other European countries, generic penetration in Belgium remains low. Alternative policy regulations aimed at enlarging the generic market and influencing pharmaceutical expenditures deserve consideration. This should include policies aiming to influence physicians' prescribing and a shared responsibility of pharmacists, physicians and patients towards expenditures.
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Generic Safety Requirements for Developing Safe Insulin Pump Software
Zhang, Yi; Jetley, Raoul; Jones, Paul L; Ray, Arnab
2011-01-01
Background The authors previously introduced a highly abstract generic insulin infusion pump (GIIP) model that identified common features and hazards shared by most insulin pumps on the market. The aim of this article is to extend our previous work on the GIIP model by articulating safety requirements that address the identified GIIP hazards. These safety requirements can be validated by manufacturers, and may ultimately serve as a safety reference for insulin pump software. Together, these two publications can serve as a basis for discussing insulin pump safety in the diabetes community. Methods In our previous work, we established a generic insulin pump architecture that abstracts functions common to many insulin pumps currently on the market and near-future pump designs. We then carried out a preliminary hazard analysis based on this architecture that included consultations with many domain experts. Further consultation with domain experts resulted in the safety requirements used in the modeling work presented in this article. Results Generic safety requirements for the GIIP model are presented, as appropriate, in parameterized format to accommodate clinical practices or specific insulin pump criteria important to safe device performance. Conclusions We believe that there is considerable value in having the diabetes, academic, and manufacturing communities consider and discuss these generic safety requirements. We hope that the communities will extend and revise them, make them more representative and comprehensive, experiment with them, and use them as a means for assessing the safety of insulin pump software designs. One potential use of these requirements is to integrate them into model-based engineering (MBE) software development methods. We believe, based on our experiences, that implementing safety requirements using MBE methods holds promise in reducing design/implementation flaws in insulin pump development and evolutionary processes, therefore improving overall safety of insulin pump software. PMID:22226258
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Sami, Haider; Maparu, Auhin K; Kumar, Ashok; Sivakumar, Sri
2012-01-01
Towards the goal of development of a generic nanomaterial delivery system and delivery of the 'as prepared' nanoparticles without 'further surface modification' in a generic way, we have fabricated a hybrid polymer capsule as a delivery vehicle in which nanoparticles are loaded within their cavity. To this end, a generic approach to prepare nanomaterials-loaded polyelectrolyte multilayered (PEM) capsules has been reported, where polystyrene sulfonate (PSS)/polyallylamine hydrochloride (PAH) polymer capsules were employed as nano/microreactors to synthesize variety of nanomaterials (metal nanoparticles; lanthanide doped inorganic nanoparticles; gadolinium based nanoparticles, cadmium based nanoparticles; different shapes of nanoparticles; co-loading of two types of nanoparticles) in their hollow cavity. These nanoparticles-loaded capsules were employed to demonstrate generic delivery of payload of nanoparticles intracellularly (HeLa cells), without the need of individual nanoparticle surface modification. Validation of intracellular internalization of nanoparticles-loaded capsules by HeLa cells was ascertained by confocal laser scanning microscopy. The green emission from Tb(3+) was observed after internalization of LaF(3):Tb(3+)(5%) nanoparticles-loaded capsules by HeLa cells, which suggests that nanoparticles in hybrid capsules retain their functionality within the cells. In vitro cytotoxicity studies of these nanoparticles-loaded capsules showed less/no cytotoxicity in comparison to blank capsules or untreated cells, thus offering a way of evading direct contact of nanoparticles with cells because of the presence of biocompatible polymeric shell of capsules. The proposed hybrid delivery system can be potentially developed to avoid a series of biological barriers and deliver multiple cargoes (both simultaneous and individual delivery) without the need of individual cargo design/modification.
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Sami, Haider; Maparu, Auhin K.; Kumar, Ashok; Sivakumar, Sri
2012-01-01
Towards the goal of development of a generic nanomaterial delivery system and delivery of the ‘as prepared’ nanoparticles without ‘further surface modification’ in a generic way, we have fabricated a hybrid polymer capsule as a delivery vehicle in which nanoparticles are loaded within their cavity. To this end, a generic approach to prepare nanomaterials-loaded polyelectrolyte multilayered (PEM) capsules has been reported, where polystyrene sulfonate (PSS)/polyallylamine hydrochloride (PAH) polymer capsules were employed as nano/microreactors to synthesize variety of nanomaterials (metal nanoparticles; lanthanide doped inorganic nanoparticles; gadolinium based nanoparticles, cadmium based nanoparticles; different shapes of nanoparticles; co-loading of two types of nanoparticles) in their hollow cavity. These nanoparticles-loaded capsules were employed to demonstrate generic delivery of payload of nanoparticles intracellularly (HeLa cells), without the need of individual nanoparticle surface modification. Validation of intracellular internalization of nanoparticles-loaded capsules by HeLa cells was ascertained by confocal laser scanning microscopy. The green emission from Tb3+ was observed after internalization of LaF3:Tb3+(5%) nanoparticles-loaded capsules by HeLa cells, which suggests that nanoparticles in hybrid capsules retain their functionality within the cells. In vitro cytotoxicity studies of these nanoparticles-loaded capsules showed less/no cytotoxicity in comparison to blank capsules or untreated cells, thus offering a way of evading direct contact of nanoparticles with cells because of the presence of biocompatible polymeric shell of capsules. The proposed hybrid delivery system can be potentially developed to avoid a series of biological barriers and deliver multiple cargoes (both simultaneous and individual delivery) without the need of individual cargo design/modification. PMID:22649489
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Analysis of French generic medicines retail market: why the use of generic medicines is limited.
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.
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Local chiral potentials with Δ -intermediate states and the structure of light nuclei
DOE Office of Scientific and Technical Information (OSTI.GOV)
Piarulli, M.; Girlanda, L.; Schiavilla, R.
We present fully local versions of the minimally non-local nucleon-nucleon potentials constructed in a previous paper [M. Piarulli et al., Phys. Rev. C 91, 024003 (2015)], and use them in hypersperical-harmonics and quantum Monte Carlo calculations of ground and excited states of 3H, 3He, 4He, 6He, and 6Li nuclei. The long-range part of these local potentials includes oneand two-pion exchange contributions without and with Δ isobars in the intermediate states up to order Q3 (Q denotes generically the low momentum scale) in the chiral expansion, while the short-range part consists of contact interactions up to order Q4. The low-energy constantsmore » multiplying these contact interactions are fitted to the 2013 Granada database in two different ranges of laboratory energies, either 0–125 MeV or 0–200 MeV, and to the deuteron binding energy and nn singlet scattering length. Fits to these data are performed for three models characterized by long- and short-range cutoffs, RL and RS respectively, ranging from (RL,RS) = (1.2, 0.8) fm down to (0.8, 0.6) fm. The long-range (short-range) cutoff regularizes the one- and two-pion exchange (contact) part of the potential.« less
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Gauged baby Skyrme model with a Chern-Simons term
NASA Astrophysics Data System (ADS)
Samoilenka, A.; Shnir, Ya.
2017-02-01
The properties of the multisoliton solutions of the (2 +1 )-dimensional Maxwell-Chern-Simons-Skyrme model are investigated numerically. Coupling to the Chern-Simons term allows for existence of the electrically charge solitons which may also carry magnetic fluxes. Two particular choices of the potential term is considered: (i) the weakly bounded potential and (ii) the double vacuum potential. In the absence of gauge interaction in the former case the individual constituents of the multisoliton configuration are well separated, while in the latter case the rotational invariance of the configuration remains unbroken. It is shown that coupling of the planar multi-Skyrmions to the electric and magnetic field strongly affects the pattern of interaction between the constituents. We analyze the dependency of the structure of the solutions, the energies, angular momenta, electric and magnetic fields of the configurations on the gauge coupling constant g , and the electric potential. It is found that, generically, the coupling to the Chern-Simons term strongly affects the usual pattern of interaction between the skyrmions, in particular the electric repulsion between the solitons may break the multisoliton configuration into partons. We show that as the gauge coupling becomes strong, both the magnetic flux and the electric charge of the solutions become quantized although they are not topological numbers.
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Incentives for market penetration of biosimilars in Belgium and in five European countries.
Swartenbroekx, N; Farfan-Portet; Espín, J; Gerkens, S
2014-12-01
Biosimilars are products similar to a biological already authorized and no longer protected by a patent. As the biological product, they contain a biological substance produced by or derived from a living organism. Alike with generics, biosimilars are potential tool to ensure savings for health systems. The current lack of market penetration of biosimilars may be seen by national authorities as a lost opportunity in terms of cost- containment. The objective of this paper is therefore to analyze the current situation in Belgium and to identify potential measures to stimulate biosimilar uptake in Belgium through an analysis of the experience in five European countries: France, Germany, The Netherlands, Spain and Sweden. This international comparison was performed using a two steps analysis: a structured review of the literature followed by a validation from experts in each country. Potential incentives and constraints were identified, i.e., prescription quotas/target, clinical guidelines, primary substitution, reference price system, fixed payment and public tendering. However, the literature reviewed provided little evaluation of the effectiveness of these policies in terms of biosimilar uptake or potential savings. The impact of these policies on biosimilar related savings is currently based on expectation and assumptions. Such kind of studies is therefore essential in the future.
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Biosimilar therapeutics-what do we need to consider?
Schellekens, Huub
2009-01-01
Patents for the first generation of approved biopharmaceuticals have either expired or are about to expire. Thus the market is opening for generic versions, referred to as 'biosimilars' (European Union) or 'follow-on protein products' (United States). Healthcare professionals need to understand the critical issues surrounding the use of biosimilars to make informed treatment decisions.The complex high-molecular-weight three-dimensional structures of biopharmaceuticals, their heterogeneity and dependence on production in living cells makes them different from classical chemical drugs. Current analytical methods cannot characterize these complex molecules sufficiently to confirm structural equivalence with reference molecules. Verification of the similarity of biosimilars to innovator biopharmaceuticals remains a key challenge. Furthermore, a critical safety issue, the immunogenicity of biopharmaceuticals, has been highlighted in recent years, confirming a need for comprehensive immunogenicity testing prior to approval and extended post-marketing surveillance.Biosimilars present a new set of challenges for regulatory authorities when compared with conventional generics. While the demonstration of a pharmacokinetic similarity is sufficient for conventional, small-molecule generic agents, a number of issues will make the approval of biosimilars more complicated. Documents recently published by the European Medicines Agency (EMEA) outlining requirements for the market approval of biosimilars provide much-needed guidance. The EMEA has approved a number of biosimilar products in a scientifically rigorous and balanced process. Outstanding issues include the interchangeability of biosimilars and innovator products, the possible need for unique naming to differentiate the various biopharmaceutical products, and more comprehensive labelling for biosimilars to include relevant clinical data.
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Perception of Generic Prescription Drugs and Utilization of Generic Drug Discount Programs
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
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Entanglement entropy in Fermi gases and Anderson's orthogonality catastrophe.
Ossipov, A
2014-09-26
We study the ground-state entanglement entropy of a finite subsystem of size L of an infinite system of noninteracting fermions scattered by a potential of finite range a. We derive a general relation between the scattering matrix and the overlap matrix and use it to prove that for a one-dimensional symmetric potential the von Neumann entropy, the Rényi entropies, and the full counting statistics are robust against potential scattering, provided that L/a≫1. The results of numerical calculations support the validity of this conclusion for a generic potential.
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The Communication Audit as a Library Management Tool.
ERIC Educational Resources Information Center
Cortez, Edwin M.; Bunge, Charles A.
1987-01-01
Discusses the relationship between effective organizational communication and specific library contexts and reviews the historical development of communication audits as a means of studying communication effectiveness. The generic structure of such audits is described and two models are presented in detail, including techniques for gathering and…
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Storytelling and German Culture.
ERIC Educational Resources Information Center
Cooper, Connie S. Eigenmann
The genre of fairytales, one structured form of storytelling, has been labeled "Marchen." German culture is orally transmitted in this generic form, and can be traced to a collection of 210 fairytales, the Grimm brothers'"Kinder-und Taus-Marchen," first published shortly after 1800. For this study, research questions were posed…
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Genie Inference Engine Rule Writer’s Guide.
1987-08-01
33 APPENDIX D. Animal Bootstrap File.............................................................. 39...APPENDIX E. Sample Run of Animal Identification Expert System.......................... 43 APPENDIX F. Numeric Test Knowledge Base...and other data s.tructures stored in the knowledge base (KB), queries the user for input, and draws conclusions. Genie (GENeric Inference Engine) is
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Ehrlich, Matthias; Schüffny, René
2013-01-01
One of the major outcomes of neuroscientific research are models of Neural Network Structures (NNSs). Descriptions of these models usually consist of a non-standardized mixture of text, figures, and other means of visual information communication in print media. However, as neuroscience is an interdisciplinary domain by nature, a standardized way of consistently representing models of NNSs is required. While generic descriptions of such models in textual form have recently been developed, a formalized way of schematically expressing them does not exist to date. Hence, in this paper we present Neural Schematics as a concept inspired by similar approaches from other disciplines for a generic two dimensional representation of said structures. After introducing NNSs in general, a set of current visualizations of models of NNSs is reviewed and analyzed for what information they convey and how their elements are rendered. This analysis then allows for the definition of general items and symbols to consistently represent these models as Neural Schematics on a two dimensional plane. We will illustrate the possibilities an agreed upon standard can yield on sampled diagrams transformed into Neural Schematics and an example application for the design and modeling of large-scale NNSs.
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The Impact on DoD of the Toxic Substances Control Act
1980-06-01
reconcile a limit of 10 ppm in the gasoline area where there is a potential for 400,000 exposures while in the rubber industry the potential is only 150,000...that the Ames test and other mutagenic tests are predictive of tumor producing potential. Many of us in toxi - cology are not impressed with this...also be completely different; so much for generic toxi - cology and for the possibility that short term testing for mutagenic effects is predictive of
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Integrating genomics and proteomics data to predict drug effects using binary linear programming.
Ji, Zhiwei; Su, Jing; Liu, Chenglin; Wang, Hongyan; Huang, Deshuang; Zhou, Xiaobo
2014-01-01
The Library of Integrated Network-Based Cellular Signatures (LINCS) project aims to create a network-based understanding of biology by cataloging changes in gene expression and signal transduction that occur when cells are exposed to a variety of perturbations. It is helpful for understanding cell pathways and facilitating drug discovery. Here, we developed a novel approach to infer cell-specific pathways and identify a compound's effects using gene expression and phosphoproteomics data under treatments with different compounds. Gene expression data were employed to infer potential targets of compounds and create a generic pathway map. Binary linear programming (BLP) was then developed to optimize the generic pathway topology based on the mid-stage signaling response of phosphorylation. To demonstrate effectiveness of this approach, we built a generic pathway map for the MCF7 breast cancer cell line and inferred the cell-specific pathways by BLP. The first group of 11 compounds was utilized to optimize the generic pathways, and then 4 compounds were used to identify effects based on the inferred cell-specific pathways. Cross-validation indicated that the cell-specific pathways reliably predicted a compound's effects. Finally, we applied BLP to re-optimize the cell-specific pathways to predict the effects of 4 compounds (trichostatin A, MS-275, staurosporine, and digoxigenin) according to compound-induced topological alterations. Trichostatin A and MS-275 (both HDAC inhibitors) inhibited the downstream pathway of HDAC1 and caused cell growth arrest via activation of p53 and p21; the effects of digoxigenin were totally opposite. Staurosporine blocked the cell cycle via p53 and p21, but also promoted cell growth via activated HDAC1 and its downstream pathway. Our approach was also applied to the PC3 prostate cancer cell line, and the cross-validation analysis showed very good accuracy in predicting effects of 4 compounds. In summary, our computational model can be used to elucidate potential mechanisms of a compound's efficacy.
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Eliminating the η-problem in SUGRA hybrid inflation with vector backreaction
NASA Astrophysics Data System (ADS)
Dimopoulos, Konstantinos; Lazarides, George; Wagstaff, Jacques M.
2012-02-01
It is shown that, when the inflaton field modulates the gauge kinetic function of the gauge fields in supergravity realisations of inflation, the dynamic backreaction leads to a new inflationary attractor solution, in which the inflaton's variation suffers additional impedance. As a result, slow-roll inflation can naturally occur along directions of the scalar potential which would be too steep and curved to support it otherwise. This provides a generic solution to the infamous eta-problem of inflation in supergravity. Moreover, it is shown that, in the new inflationary attractor, the spectral index of the generated curvature perturbations is kept mildly red despite eta of order unity. The above findings are applied to a model of hybrid inflation in supergravity with a generic Kähler potential. The spectral index of the generated curvature perturbations is found to be 0.97-0.98, in excellent agreement with observations. The gauge field can play the role of the vector curvaton after inflation but observable statistical anisotropy requires substantial tuning of the gauge coupling.
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[Can we transfer the mechanisms of the generics market to biosimilars?
Jacke, Ch O; Wild, F
2016-12-15
Personalized medicines such as biologics and their generic equivalents, biosimilars, are pouring onto the pharmaceutical markets. Data of 16 private health insurance companies were used to describe the market shares of selected biosimilars available in 2014 and 2015. The purpose of this study focuses on the question of whether market access of biosimilars will lead to a price competition of the expense of innovation competition. The results show that prescriptions of biosimilars made up 37% of total prescriptions in 2015 compared to 35% in 2014, and that their share of prescription costs went up from 21% to 23% in the same period. Price competition similar to that found in the generic markets has been established for erythropoietin and filgrastim. The same has not been observed for follitropin alfa and somatropin due to the limited number of competitors and products available at this stage. No definitive conclusions can be drown from the results at this stage. Time will tell whether it will be possible for physicians and individuals with private health insurance to fully leverage the savings potential of biosimilars while safeguarding patient safety.
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A randomized controlled trial of an appearance-based dietary intervention.
Whitehead, Ross D; Ozakinci, Gözde; Perrett, David I
2014-01-01
Inadequate fruit and vegetable consumption precipitates preventable morbidity and mortality. The efficacy of an appearance-based dietary intervention was investigated, which illustrates the beneficial effect that fruit and vegetable consumption has on skin appearance. Participants were randomly allocated to three groups receiving information-only or a generic or own-face appearance-based intervention. Diet was recorded at baseline and 10 weekly follow-ups. Participants in the generic and own-face intervention groups witnessed on-screen stimuli and received printed photographic materials to illustrate the beneficial effect of fruit and vegetable consumption on skin color. Controlling for baseline diet, a significant effect of intervention group was found on self-reported fruit and vegetable intake among 46 completers who were free of medical and personal reasons preventing diet change. The own-face appearance-based intervention group reported a significant, sustained improvement in fruit and vegetable consumption whereas the information-only and generic appearance-based intervention groups reported no significant dietary changes. Seeing the potential benefits of fruit and vegetable consumption on own skin color may motivate dietary improvement. 2014 APA, all rights reserved
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Establishing advanced practice for medical imaging in New Zealand
Yielder, Jill; Young, Adrienne; Park, Shelley; Coleman, Karen
2014-01-01
IntroductionThis article presents the outcome and recommendations following the second stage of a role development project conducted on behalf of the New Zealand Institute of Medical Radiation Technology (NZIMRT). The study sought to support the development of profiles and criteria that may be used to formulate Advanced Scopes of Practice for the profession. It commenced in 2011, following on from initial research that occurred between 2005 and 2008 investigating role development and a possible career structure for medical radiation technologists (MRTs) in New Zealand (NZ). MethodsThe study sought to support the development of profiles and criteria that could be used to develop Advanced Scopes of Practice for the profession through inviting 12 specialist medical imaging groups in NZ to participate in a survey. ResultsFindings showed strong agreement on potential profiles and on generic criteria within them; however, there was less agreement on specific skills criteria within specialist areas. ConclusionsThe authors recommend that one Advanced Scope of Practice be developed for Medical Imaging, with the establishment of generic and specialist criteria. Systems for approval of the overall criteria package for any individual Advanced Practitioner (AP) profile, audit and continuing professional development requirements need to be established by the Medical Radiation Technologists Board (MRTB) to meet the local needs of clinical departments. It is further recommended that the NZIMRT and MRTB promote and support the need for an AP pathway for medical imaging in NZ. PMID:26229631
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Establishing advanced practice for medical imaging in New Zealand
DOE Office of Scientific and Technical Information (OSTI.GOV)
Yielder, Jill, E-mail: j.yielder@auckland.ac.nz; Young, Adrienne; Park, Shelley
Introduction: This article presents the outcome and recommendations following the second stage of a role development project conducted on behalf of the New Zealand Institute of Medical Radiation Technology (NZIMRT). The study sought to support the development of profiles and criteria that may be used to formulate Advanced Scopes of Practice for the profession. It commenced in 2011, following on from initial research that occurred between 2005 and 2008 investigating role development and a possible career structure for medical radiation technologists (MRTs) in New Zealand (NZ). Methods: The study sought to support the development of profiles and criteria that couldmore » be used to develop Advanced Scopes of Practice for the profession through inviting 12 specialist medical imaging groups in NZ to participate in a survey. Results: Findings showed strong agreement on potential profiles and on generic criteria within them; however, there was less agreement on specific skills criteria within specialist areas. Conclusions: The authors recommend that one Advanced Scope of Practice be developed for Medical Imaging, with the establishment of generic and specialist criteria. Systems for approval of the overall criteria package for any individual Advanced Practitioner (AP) profile, audit and continuing professional development requirements need to be established by the Medical Radiation Technologists Board (MRTB) to meet the local needs of clinical departments. It is further recommended that the NZIMRT and MRTB promote and support the need for an AP pathway for medical imaging in NZ.« less
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Vortex lattices and defect-mediated viscosity reduction in active liquids
NASA Astrophysics Data System (ADS)
Slomka, Jonasz; Dunkel, Jorn
2016-11-01
Generic pattern-formation and viscosity-reduction mechanisms in active fluids are investigated using a generalized Navier-Stokes model that captures the experimentally observed bulk vortex dynamics in microbial suspensions. We present exact analytical solutions including stress-free vortex lattices and introduce a computational framework that allows the efficient treatment of previously intractable higher-order shear boundary conditions. Large-scale parameter scans identify the conditions for spontaneous flow symmetry breaking, defect-mediated low-viscosity phases and negative-viscosity states amenable to energy harvesting in confined suspensions. The theory uses only generic assumptions about the symmetries and long-wavelength structure of active stress tensors, suggesting that inviscid phases may be achievable in a broad class of non-equilibrium fluids by tuning confinement geometry and pattern scale selection.
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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.
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NASA Astrophysics Data System (ADS)
Heitlager, Ilja; Helms, Remko; Brinkkemper, Sjaak
Information Technology Outsourcing practice and research mainly considers the outsourcing phenomenon as a generic fulfilment of the IT function by external parties. Inspired by the logic of commodity, core competencies and economies of scale; assets, existing departments and IT functions are transferred to external parties. Although the generic approach might work for desktop outsourcing, where standardisation is the dominant factor, it does not work for the management of mission critical applications. Managing mission critical applications requires a different approach where building relationships is critical. The relationships involve inter and intra organisational parties in a multi-sourcing arrangement, called an IT service chain, consisting of multiple (specialist) parties that have to collaborate closely to deliver high quality services.
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Generic command interpreter for robot controllers
DOE Office of Scientific and Technical Information (OSTI.GOV)
Werner, J.
1991-04-09
Generic command interpreter programs have been written for robot controllers at Sandia National Laboratories (SNL). Each interpreter program resides on a robot controller and interfaces the controller with a supervisory program on another (host) computer. We call these interpreter programs monitors because they wait, monitoring a communication line, for commands from the supervisory program. These monitors are designed to interface with the object-oriented software structure of the supervisory programs. The functions of the monitor programs are written in each robot controller's native language but reflect the object-oriented functions of the supervisory programs. These functions and other specifics of the monitormore » programs written for three different robots at SNL will be discussed. 4 refs., 4 figs.« less
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Safety Case Patterns: Theory and Applications
NASA Technical Reports Server (NTRS)
Denney, Ewen W.; Pai, Ganesh J.
2015-01-01
We develop the foundations for a theory of patterns of safety case argument structures, clarifying the concepts involved in pattern specification, including choices, labeling, and well-founded recursion. We specify six new patterns in addition to those existing in the literature. We give a generic way to specify the data required to instantiate patterns and a generic algorithm for their instantiation. This generalizes earlier work on generating argument fragments from requirements tables. We describe an implementation of these concepts in AdvoCATE, the Assurance Case Automation Toolset, showing how patterns are defined and can be instantiated. In particular, we describe how our extended notion of patterns can be specified, how they can be instantiated in an interactive manner, and, finally, how they can be automatically instantiated using our algorithm.
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Proposal for a common nomenclature for fragment ions in mass spectra of lipids
Hartler, Jürgen; Christiansen, Klaus; Gallego, Sandra F.; Peng, Bing; Ahrends, Robert
2017-01-01
Advances in mass spectrometry-based lipidomics have in recent years prompted efforts to standardize the annotation of the vast number of lipid molecules that can be detected in biological systems. These efforts have focused on cataloguing, naming and drawing chemical structures of intact lipid molecules, but have provided no guidelines for annotation of lipid fragment ions detected using tandem and multi-stage mass spectrometry, albeit these fragment ions are mandatory for structural elucidation and high confidence lipid identification, especially in high throughput lipidomics workflows. Here we propose a nomenclature for the annotation of lipid fragment ions, describe its implementation and present a freely available web application, termed ALEX123 lipid calculator, that can be used to query a comprehensive database featuring curated lipid fragmentation information for more than 430,000 potential lipid molecules from 47 lipid classes covering five lipid categories. We note that the nomenclature is generic, extendable to stable isotope-labeled lipid molecules and applicable to automated annotation of fragment ions detected by most contemporary lipidomics platforms, including LC-MS/MS-based routines. PMID:29161304
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Proposal for a common nomenclature for fragment ions in mass spectra of lipids.
Pauling, Josch K; Hermansson, Martin; Hartler, Jürgen; Christiansen, Klaus; Gallego, Sandra F; Peng, Bing; Ahrends, Robert; Ejsing, Christer S
2017-01-01
Advances in mass spectrometry-based lipidomics have in recent years prompted efforts to standardize the annotation of the vast number of lipid molecules that can be detected in biological systems. These efforts have focused on cataloguing, naming and drawing chemical structures of intact lipid molecules, but have provided no guidelines for annotation of lipid fragment ions detected using tandem and multi-stage mass spectrometry, albeit these fragment ions are mandatory for structural elucidation and high confidence lipid identification, especially in high throughput lipidomics workflows. Here we propose a nomenclature for the annotation of lipid fragment ions, describe its implementation and present a freely available web application, termed ALEX123 lipid calculator, that can be used to query a comprehensive database featuring curated lipid fragmentation information for more than 430,000 potential lipid molecules from 47 lipid classes covering five lipid categories. We note that the nomenclature is generic, extendable to stable isotope-labeled lipid molecules and applicable to automated annotation of fragment ions detected by most contemporary lipidomics platforms, including LC-MS/MS-based routines.
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Drozdowska, Aleksandra; Hermanowski, Tomasz
2016-01-01
Escalating pharmaceutical costs have become a global challenge for both governments and patients. Generic substitution is one way of decreasing these costs. The aim of this study was to investigate factors associated with patients' choice between generic drugs and innovator drugs. The survey was conducted in June 2013, 1000 people from across Poland were chosen as a representative population sample. The outcome (a preference for generics/a preference for innovator pharmaceuticals/no preference) was modeled by multinomial logistic regression, adjusted for several variables describing patients' sensitivity to selected generic features (price, brand, and country of origin), to third-party opinions about generics (information on generics in the mass media, opinions of health professionals (i.e. physicians, pharmacists), relatives/friends), as well as patients' personal experiences and income per household. The results supported the predictive capacity of most independent variables (except for patient sensitivity to the country of origin and to the information on generics in the mass media), denoting patients' preferences toward generic substitution. Patient sensitivity to recommendations by physicians, generic brand, and household income were the strongest predictors of the choice between generic and innovator pharmaceuticals (P < 0.001). The probability of choosing generics over innovator drugs was significantly higher among respondents with the lowest income levels, in those who were indifferent to generic brand or their physician's opinion, as well as in respondents who were sensitive to recommendations by pharmacists or attached a greater value to a past experience with generics (their own experience or that of relatives/friends). In consideration of the foregoing, awareness-raising campaigns may be recommended, supported by a variety of systemic solutions and tools to encourage generic substitution. Copyright © 2016 Elsevier Inc. All rights reserved.
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Marennine, Promising Blue Pigments from a Widespread Haslea Diatom Species Complex
Gastineau, Romain; Turcotte, François; Pouvreau, Jean-Bernard; Morançais, Michèle; Fleurence, Joël; Windarto, Eko; Semba Prasetiya, Fiddy; Arsad, Sulastri; Jaouen, Pascal; Babin, Mathieu; Coiffard, Laurence; Couteau, Céline; Bardeau, Jean-François; Jacquette, Boris; Leignel, Vincent; Hardivillier, Yann; Marcotte, Isabelle; Bourgougnon, Nathalie; Tremblay, Réjean; Deschênes, Jean-Sébastien; Badawy, Hope; Pasetto, Pamela; Davidovich, Nikolai; Hansen, Gert; Dittmer, Jens; Mouget, Jean-Luc
2014-01-01
In diatoms, the main photosynthetic pigments are chlorophylls a and c, fucoxanthin, diadinoxanthin and diatoxanthin. The marine pennate diatom Haslea ostrearia has long been known for producing, in addition to these generic pigments, a water-soluble blue pigment, marennine. This pigment, responsible for the greening of oysters in western France, presents different biological activities: allelopathic, antioxidant, antibacterial, antiviral, and growth-inhibiting. A method to extract and purify marennine has been developed, but its chemical structure could hitherto not be resolved. For decades, H. ostrearia was the only organism known to produce marennine, and can be found worldwide. Our knowledge about H. ostrearia-like diatom biodiversity has recently been extended with the discovery of several new species of blue diatoms, the recently described H. karadagensis, H. silbo sp. inedit. and H. provincialis sp. inedit. These blue diatoms produce different marennine-like pigments, which belong to the same chemical family and present similar biological activities. Aside from being a potential source of natural blue pigments, H. ostrearia-like diatoms thus present a commercial potential for aquaculture, cosmetics, food and health industries. PMID:24879542
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[Generic drugs: good or bad? Physician's knowledge of generic drugs and prescribing habits].
García, A J; Martos, F; Leiva, F; Sánchez de la Cuesta, F
2003-01-01
In this article we analyze the responses of 1220 Spanish physicians who participated in a survery about generic drugs. A previously validated questionnaire was sent to physicians through the Spanish Medical Councils of the different provinces. Four items were analyzed: what doctors know about generic drugs (knowledge); physicians' prescribing habits concerning these drugs (attitude and professional competence); how prescription of generic drugs effects pharmaceutical costs amd, finally, what doctors believe a generic drug should be. The influence of physician-related variables (age, type of contract, specialty, workload, etc.) on prescribing of generic drugs was also analyzed. In view of the results, we believe that to rationalize expenditure through and appropriate policy on generic drugs Spanish health authorities should offer more and better training and information (clear and independent) about what generic drugs are.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-28
... Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative... Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service...: Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. Abstract...
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Generic Example Proving Criteria for All
ERIC Educational Resources Information Center
Yopp, David; Ely, Rob; Johnson-Leung, Jennifer
2015-01-01
We review literature that discusses generic example proving and highlight ambiguities that pervade our research community's discourse about generic example arguments. We distinguish between pedagogical advice for choosing good examples that can serve as generic examples when teaching and advice for developing generic example arguments. We provide…
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Akaleephan, Chutima; Wibulpolprasert, Suwit; Sakulbumrungsil, Rungpetch; Luangruangrong, Paithip; Jitraknathee, Anchalee; Aeksaengsri, Achara; Udomaksorn, Siripa; Tangcharoensathien, Viroj; Tantivess, Sripen
2009-07-01
In Thailand and the US negotiating FTA, the 'TRIPs-Plus' is one of the US proposal which would result in an extension of market exclusivity of innovative drugs. In addition, it would foreseeably lead to high and unaffordable medicine prices and inaccessibility to essential medicines. To quantify the impact on medicine expense and medicine accessibility. Based on 2000 to 2003 Thai Food and Drug Administration (FDA)'s and the Drug & Medical Supply Information Center (DMSIC), costs and accessibility were estimated upon the price and quantity costing between innovative drugs and their generics plus some parameters found from their competitive behaviour. Thereafter, we simulated the 10-year potential additional expense on the 2003 unit price of the patented and monopolized non-patented medicines. In 2003, the availability of generics helped to save 104.5% of actual expense and the accessibility would increase by 53.6%. By extension of market exclusivity, given that there were 60 new items approved annually, the cumulative potential expense was projected to be $US 6.2 million for the first year to $US 5215.8 million in tenth year. The TRIPs-Plus proposal would result in a significant increase in the medicine expense; and a delay in the increase in drug accessibility via generics. Several options as well as other related mechanisms to help reduce the negative impact are proposed.
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Approaches to Foster Transfer of Formal Principles: Which Route to Take?
Schalk, Lennart; Saalbach, Henrik; Stern, Elsbeth
2016-01-01
Enabling learners to transfer knowledge about formal principles to new problems is a major aim of science and mathematics education, which, however, is notoriously difficult to reach. Previous research advocates different approaches of how to introduce principles to foster the transfer of knowledge about formal principles. One approach suggests teaching a generic formalism of the principles. Another approach suggests presenting (at least) two concrete cases instantiating the principle. A third approach suggests presenting a generic formalism accompanied by a case. As yet, though, empirical results regarding the transfer potential of these approaches are mixed and difficult to integrate as the three approaches have rarely been tested competitively. Furthermore, the approaches have been evaluated in relation to different control conditions, and they have been assessed using varying transfer measures. In the present experiment, we introduced undergraduates to the formal principles of propositional logic with the aim to systematically compare the transfer potential of the different approaches in relation to each other and to a common control condition by using various learning and transfer tasks. Results indicate that all approaches supported successful learning and transfer of the principles, but also caused systematic differences in the magnitude of transfer. Results indicate that the combination of a generic formalism with a case was surprisingly unsuccessful while learners who compared two cases outperformed the control condition. We discuss how the simultaneous assessment of the different approaches allows to more precisely capture the underlying learning mechanisms and to advance theory on how these mechanisms contribute to transfer performance.
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Hassali, Mohamed Azmi; Wong, Zhi Yen; Alrasheedy, Alian A; Saleem, Fahad; Mohamad Yahaya, Abdul Haniff; Aljadhey, Hisham
2014-09-01
This review was conducted to document published literature related to physicians' knowledge, attitudes, and perceptions of generic medicines in low- and middle-income countries (LMICs) and to compare the findings with high-income countries. A systematic search of articles published in peer-reviewed journals from January 2001 to February 2013 was performed. The search comprised nine electronic databases. The search strategy involved using Boolean operators for combinations of the following terms: generic medicines, generic medications, generic drugs, generic, generic substitution, generic prescribing, international non-proprietary, prescribers, doctors, general practitioners, physicians, and specialists. Sixteen articles were included in this review. The majority (n=11) were from high income countries and five from LMICs. The main difference between high income countries and LMICs is that physicians from high income countries generally have positive views whereas those from LMICs tend to have mixed views regarding generic medicines. Few similarities were identified among different country income groups namely low level of physicians' knowledge of the basis of bioequivalence testing, cost of generic medicines as an encouraging factor for generic medicine prescribing, physicians' concerns towards safety and quality of generic medicines and effect of pharmaceutical sales representative on generic medicine prescribing. The present literature review revealed that physicians from LMICs tend to have mixed views regarding generic medicines. This may be due to differences in the health care system and pharmaceutical funding system, medicine policies, the level of educational interventions, and drug information sources in countries of different income levels. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
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Assessing bioequivalence of generic antiepilepsy drugs.
Krauss, Gregory L; Caffo, Brian; Chang, Yi-Ting; Hendrix, Craig W; Chuang, Kelly
2011-08-01
Patients with epilepsy are often concerned that switching between brand-name and generic formulations of antiepilepsy drugs (AEDs) may cause clinically significant changes in plasma drug concentrations. We assessed bioequivalence (BE) studies for approved generic AEDs to evaluate US Food and Drug Administration claims that: (1) generic AEDs are accurate copies of reference formulations; (2) delivery of reference formulations may be as variable as generic AEDs and so provide no increased benefit; and (3) switches between generic AED formulations are safe and effective. We determined differences in 90% confidence interval limits for total drug exposure (AUC(0-t) ) and peak concentration (Cmax) ratios of generic and reference formulations during fasting and fed BE studies. We simulated BE between generic formulations after adjusting for reference values. AUC(0-t) values of approved reference and generic formulations differed by <15% in 99% of BE studies; Cmax differed by <15% in 89% of studies. Food affected variability of Cmax but not AUC(0-t) . Intersubject variability in Cmax and AUC(0-t) was small and similar for reference and generic products. In simulated switches between 595 pairs of generic AED formulations, estimated AUC(0-t) differed by >15% for 17% of pairs; estimated Cmax differed by >15% for 39%. AEDs with low bioavailability and solubility (eg, oxcarbazepine) had the greatest variability in BE. Most generic AED products provide total drug delivery (AUC) similar to reference products; differences in peak concentrations between formulations are more common. Switches between generic AED products may cause greater changes in plasma drug concentrations than generic substitutions of reference products. Copyright © 2011 American Neurological Association.
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An Investigation of Generic Structures of Pakistani Doctoral Thesis Acknowledgements
ERIC Educational Resources Information Center
Rofess, Sakander; Mahmood, Muhammad Asim
2015-01-01
This paper investigates Pakistani doctoral thesis acknowledgements from genre analysis perspective. A corpus of 235 PhD thesis acknowledgements written in English was taken from Pakistani doctoral theses collected from eight different disciplines. HEC Research Repository of Pakistan was used as a data sources. The theses written by Pakistani…
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42 CFR 423.578 - Exceptions process.
Code of Federal Regulations, 2010 CFR
2010-10-01
... cost-sharing structure. Each Part D plan sponsor that provides prescription drug benefits for Part D... sponsor required to cover a non-preferred drug at the generic drug cost-sharing level if the plan... tier in which it places very high cost and unique items, such as genomic and biotech products, the...
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Silicon ribbon stress/strain workshop
NASA Technical Reports Server (NTRS)
Leipold, M. H.
1985-01-01
Highlights of the Flat Plate Solar Array Project sponsored Silicon Ribbon Stress/Strain Workshop that was held 23 to 24 January 1985 are reported. The presentations and discussions were aimed at acquiring a generic understanding of the sources of stress, deformation, and structural characteristics occurring during the growth of silicon ribbon.
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A Study of English Acknowledgements Written by EFL Thai Learners
ERIC Educational Resources Information Center
Jaroenkitboworn, Kandaporn
2014-01-01
This research investigates English acknowledgements in dissertations written by Thai PhD students, particularly the generic structure and linguistic patterns of gratitude expressions used in the acknowledgements. Following the line of the move analysis in acknowledgements of Hyland (2004), this article analyzed 70 acknowledgements accompanying PhD…
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Pedagogical Basis of DAS Formalism in Engineering Education
ERIC Educational Resources Information Center
Hiltunen, J.; Heikkinen, E.-P.; Jaako, J.; Ahola, J.
2011-01-01
The paper presents a new approach for a bachelor-level curriculum structure in engineering. The approach is called DAS formalism according to its three phases: description, analysis and synthesis. Although developed specifically for process and environmental engineering, DAS formalism has a generic nature and it could also be used in other…
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Effects of Noun Phrase Type on Sentence Complexity
ERIC Educational Resources Information Center
Gordon, Peter C.; Hendrick, Randall; Johnson, Marcus
2004-01-01
A series of self-paced reading time experiments was performed to assess how characteristics of noun phrases (NPs) contribute to the difference in processing difficulty between object- and subject-extracted relative clauses. Structural semantic characteristics of the NP in the embedded clause (definite vs. indefinite and definite vs. generic) did…
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A distributed telerobotics construction set
NASA Technical Reports Server (NTRS)
Wise, James D.
1994-01-01
During the course of our research on distributed telerobotic systems, we have assembled a collection of generic, reusable software modules and an infrastructure for connecting them to form a variety of telerobotic configurations. This paper describes the structure of this 'Telerobotics Construction Set' and lists some of the components which comprise it.
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The risks and costs of multiple-generic substitution of topiramate.
Duh, M S; Paradis, P E; Latrémouille-Viau, D; Greenberg, P E; Lee, S P; Durkin, M B; Wan, G J; Rupnow, M F T; LeLorier, J
2009-06-16
To investigate clinical and economic consequences following generic substitution of one vs multiple generics of topiramate (Topamax; Ortho-McNeil Neurologics, Titusville, NJ). Medical and pharmacy claims data of Régie de l'Assurance-Maladie du Québec from January 2006 to October 2007 were used. Patients with epilepsy treated with topiramate were selected. An open-cohort design was used to classify the observation period into periods of brand, single-generic, and multiple-generic use. One-year generic-switch and switchback-to-brand rates were estimated using Kaplan-Meier methodology. Medical resource utilization and costs were compared among the three periods using multivariate regression analysis. In total, 948 patients were observed during 1,105 person-years of brand use, 233 person-years of single-generic use, and 92 person-years of multiple-generic use. A total of 23% of generic users received at least two different generic versions. Compared to brand use, multiple-generic use was associated with higher utilization of other prescription drugs (incidence rate ratio [IRR] = 1.27, 95% confidence interval [CI] = 1.24-1.31), higher hospitalization rates (0.48 vs 0.83 visit/person-year, IRR = 1.65, 95% CI = 1.28-2.13), and longer hospital stays (2.6 vs 3.9 days/person-year, IRR = 1.43, 95% CI = 1.27-1.60), but the effect was less pronounced in single-generic use (hospitalization: IRR = 1.08, 95% CI = 0.88-1.34, length of stay: IRR = 1.12, 95% CI = 1.03-1.23). The risk of head injury or fracture was nearly three times higher (hazard ratio = 2.84, 95% CI = 1.24-6.48) following a generic-to-generic switch compared to brand use. The total annualized health care cost per patient was higher in the multiple-generic than brand periods by C$1,716 (cost ratio = 1.21, p = 0.0420). Multiple-generic substitution of topiramate was significantly associated with negative outcomes, such as hospitalizations and injuries, and increased health care costs.