Central repository for low- and intermediate-level waste (ALMA) conceptual design, siting and safety study

International Nuclear Information System (INIS)

Kjellbert, N.; Haeggblom, H.; Cederstroem, M.; Lundgren, T.

1980-07-01

A generic design, siting and safety study of a proposed repository for low- and intermediate-level waste has been made. Special emphasis has been placed on safety characterostics. The conceptual design and the generic site, on which the study is based, are realistically chosen in accordance with present construction techniques and the existing geohydrological conditions in Sweden. (Auth.)

Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.

Science.gov (United States)

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

Generic Hurricane Extreme Seas State

DEFF Research Database (Denmark)

Wehmeyer, Christof; Skourup, Jesper; Frigaard, Peter

2012-01-01

Extreme sea states, which the IEC 61400-3 (2008) standard requires for the ultimate limit state (ULS) analysis of offshore wind turbines are derived to establish the design basis for the conceptual layout of deep water floating offshore wind turbine foundations in hurricane affected areas....... Especially in the initial phase of floating foundation concept development, site specific metocean data are usually not available. As the areas of interest are furthermore not covered by any design standard, in terms of design sea states, generic and in engineering terms applicable environmental background...... data is required for a type specific conceptual design. ULS conditions for different return periods are developed, which can subsequently be applied in siteindependent analysis and conceptual design. Recordings provided by National Oceanic and Atmospheric Administration (NOAA), of hurricanes along...

Retailing policies for generic medicines.

Science.gov (United States)

Narciso, Susana

2005-06-01

As there is general disagreement about the way generic medicines should be commercialized, two retailing policies are analyzed, taking into account their effects on the welfare of patients, government, pharmacies and physicians. In the first policy scenario, pharmacies are allowed to substitute generic medicines for branded ones, while in the second, substitution is forbidden. In both cases a pharmacies association is allowed to have a share in the production of generic medicines. The model predicts that under some conditions patients may prefer substitution by pharmacies but when doctors' decisions are binding, they are never "excessively bad". However, the policy choice belongs to the government, which prefers to allow for substitution more often than patients would like.

Impact of alternative interventions on changes in generic dispensing rates.

Science.gov (United States)

O'Malley, A James; Frank, Richard G; Kaddis, Atheer; Rothenberg, Barbara M; McNeil, Barbara J

2006-10-01

To evaluate the effectiveness of four alternative interventions (member mailings, advertising campaigns, free generic drug samples to physicians, and physician financial incentives) used by a major health insurer to encourage its members to switch to generic drugs. Using claim-level data from Blue Cross Blue Shield of Michigan, we evaluated the success of four interventions implemented during 2000-2003 designed to increase the use of generic drugs among its members. Around 13 million claims involving seven important classes of drugs were used to assess the effectiveness of the interventions. For each intervention a control group was developed that most closely resembled the corresponding intervention group. Logistic regression models with interaction effects between the treatment group (intervention versus control) and the status of the intervention (active versus not active) were used to evaluate if the interventions had an effect on the generic dispensing rate (GDR). Because the mail order pharmacy was considered more aggressive at converting prescriptions to generics, separate generic purchasing models were fitted to retail and mail order claims. In secondary analyses separate models were also fitted to claims involving a new condition and claims refilled for preexisting conditions. The interventions did not appear to increase the market penetration of generic drugs for either retail or mail order claims, or for claims involving new or preexisting conditions. In addition, we found that the ratio of copayments for brand name to generic drugs had a large positive effect on the GDR. The interventions did not appear to directly influence the GDR. Financial incentives expressed to consumers through benefit designs have a large influence on their switching to generic drugs and on the less-costly mail-order mode of purchase.

Seismic sensitivity study of a generic CANDU nuclear power plant: Soil-structure interaction

International Nuclear Information System (INIS)

Lee, L.S.S.; Duff, C.G.

1983-01-01

The seismic sensitivity and capability study for a generic CANDU Plant is part of an overall development program of design standardization. The purpose of this paper is to investigate the sensitivities of structural responses and floor response spectra (FRS) to variations of structural and soil parameters. In the seismic design standardization, a wide range of soil conditions is considered and the envelopes of the resulting site spectra (soil-structure interaction effect) are then used for the design of the generic plant. The nuclear island structures considered herein have different relative stiffness and one of them has two layout/structure schemes: one is relatively flexible and the other is moderately stiff. In the preliminary phase of the seismic sensitivity study presented hereby, the soil-structure interaction seismic analysis is based on the half-space modelling (soil-spring lumped-mass) method and the response spectrum method for the seismic responses. Distinct patterns and sensitivity of the site spectrum analysis for structure schemes of different relative stiffness and for different structural elevations are observed and discussed. (orig.)

Generic medicines and generic substitution: contrasting perspectives of stakeholders in Ireland.

Science.gov (United States)

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

A new top boundary condition for modeling surface diffusive exchange of a generic volatile tracer: theoretical analysis and application to soil evaporation

Directory of Open Access Journals (Sweden)

J. Y. Tang

2013-02-01

Full Text Available We describe a new top boundary condition (TBC for representing the air–soil diffusive exchange of a generic volatile tracer. This new TBC (1 accounts for the multi-phase flow of a generic tracer; (2 accounts for effects of soil temperature, pH, solubility, sorption, and desorption processes; (3 enables a smooth transition between wet and dry soil conditions; (4 is compatible with the conductance formulation for modeling air–water volatile tracer exchange; and (5 is applicable to site, regional, and global land models.

Based on the new TBC, we developed new formulations for bare-soil resistance and corresponding soil evaporation efficiency. The new soil resistance is predicted as the reciprocal of the harmonic sum of two resistances: (1 gaseous and aqueous molecular diffusion and (2 liquid mass flow resulting from the hydraulic pressure gradient between the soil surface and center of the topsoil control volume. We compared the predicted soil evaporation efficiency with those from several field and laboratory soil evaporation measurements and found good agreement with the typically observed two-stage soil evaporation curves. Comparison with the soil evaporation efficiency equation of Lee and Pielke (1992; hereafter LP92 indicates that their equation can overestimate soil evaporation when the atmospheric resistance is low and underestimate soil evaporation when the soil is dry. Using a synthetic inversion experiment, we demonstrated that using inverted soil resistance data from field measurements to derive empirical soil resistance formulations resulted in large uncertainty because (1 the inverted soil resistance data are always severely impacted by measurement error and (2 the derived empirical equation is very sensitive to the number of data points and the assumed functional form of the resistance.

We expect the application of our new TBC in land models will provide a consistent representation for the diffusive tracer

Intermediates and Generic Convergence to Equilibria

DEFF Research Database (Denmark)

Marcondes de Freitas, Michael; Wiuf, Carsten; Feliu, Elisenda

2017-01-01

Known graphical conditions for the generic and global convergence to equilibria of the dynamical system arising from a reaction network are shown to be invariant under the so-called successive removal of intermediates, a systematic procedure to simplify the network, making the graphical conditions...

Dirac perturbations on Schwarzschild-anti-de Sitter spacetimes: Generic boundary conditions and new quasinormal modes

Science.gov (United States)

Wang, Mengjie; Herdeiro, Carlos; Jing, Jiliang

2017-11-01

We study Dirac quasinormal modes of Schwarzschild-anti-de Sitter (Schwarzschild-AdS) black holes, following the generic principle for allowed boundary conditions proposed in [M. Wang, C. Herdeiro, and M. O. P. Sampaio, Phys. Rev. D 92, 124006 (2015)., 10.1103/PhysRevD.92.124006]. After deriving the equations of motion for Dirac fields on the aforementioned background, we impose vanishing energy flux boundary conditions to solve these equations. We find a set of two Robin boundary conditions are allowed. These two boundary conditions are used to calculate Dirac normal modes on empty AdS and quasinormal modes on Schwarzschild-AdS black holes. In the former case, we recover the known normal modes of empty AdS; in the latter case, the two sets of Robin boundary conditions lead to two different branches of quasinormal modes. The impact on these modes of the black hole size, the angular momentum quantum number and the overtone number are discussed. Our results show that vanishing energy flux boundary conditions are a robust principle, applicable not only to bosonic fields but also to fermionic fields.

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

Science.gov (United States)

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

2015-07-01

Accurate estimation of tree and forest biomass is key to evaluating forest ecosystem functions and the global carbon cycle. Allometric equations that estimate tree biomass from a set of predictors, such as stem diameter and tree height, are commonly used. Most allometric equations are site specific, usually developed from a small number of trees harvested in a small area, and are either species specific or ignore interspecific differences in allometry. Due to lack of site-specific allometries, local equations are often applied to sites for which they were not originally developed (foreign sites), sometimes leading to large errors in biomass estimates. In this study, we developed generic allometric equations for aboveground biomass and component (stem, branch, leaf, and root) biomass using large, compiled data sets of 1203 harvested trees belonging to 102 species (60 deciduous angiosperm, 32 evergreen angiosperm, and 10 evergreen gymnosperm species) from 70 boreal, temperate, and subtropical natural forests in Japan. The best generic equations provided better biomass estimates than did local equations that were applied to foreign sites. The best generic equations included explanatory variables that represent interspecific differences in allometry in addition to stem diameter, reducing error by 4-12% compared to the generic equations that did not include the interspecific difference. Different explanatory variables were selected for different components. For aboveground and stem biomass, the best generic equations had species-specific wood specific gravity as an explanatory variable. For branch, leaf, and root biomass, the best equations had functional types (deciduous angiosperm, evergreen angiosperm, and evergreen gymnosperm) instead of functional traits (wood specific gravity or leaf mass per area), suggesting importance of other traits in addition to these traits, such as canopy and root architecture. Inclusion of tree height in addition to stem diameter improved

Potential cost savings from generic medicines – protecting the ...

African Journals Online (AJOL)

the difference between brand and generic medicines listed for that algorithm, and also as the median of differences between generic medicines for the same condition. Results: Three of the algorithms .... Protecting the PMBs, as a key element of the new community-rated medical schemes environment, is therefore vital.

Evaluating Site-Specific and Generic Spatial Models of Aboveground Forest Biomass Based on Landsat Time-Series and LiDAR Strip Samples in the Eastern USA

Science.gov (United States)

Ram Deo; Matthew Russell; Grant Domke; Hans-Erik Andersen; Warren Cohen; Christopher Woodall

2017-01-01

Large-area assessment of aboveground tree biomass (AGB) to inform regional or national forest monitoring programs can be efficiently carried out by combining remotely sensed data and field sample measurements through a generic statistical model, in contrast to site-specific models. We integrated forest inventory plot data with spatial predictors from Landsat time-...

The generics in transplantation and the rules on their use.

Science.gov (United States)

Masri, Marwan

2003-06-01

By definition a product identified by its official chemical name rather than an advertised brand name is called a generic. If a drug exert its pharmacological effects at the same site, have the same potency, same dosage form and same bioavailability as a brand name, reference listed drug (RLD), is considered as a generic. However inactive ingredients can differ between brand name and generic. It is through the regulations of the FDA that the generics gained many ground in the drug market, they currently account to more than 42% of the total prescription in the USA. These regulations include the abbreviated new drug application (ANDA) for the registration process and drug substitution at the pharmacy level without patient or physician consent. This coupled with a keen interest of third party payers and the health authorities to reduce the high transplant health budget (over 2 Billion US $) made it a necessity to introduce the generics into the field of transplantation. Using the above mentioned definition we can theoretically say that all anti-lymphocytes, produced in the same animal species, are generic of each. Moreover, monoclonal antibodies that are directed against the same target and have the same bioavailability are also consider generics to each other. Of all the immunosuppressive drugs that have been introduced into the field of transplantation none has been as dominant as Cyclosporine. Cyclosporine became and still is the backbone for any immunosuppressive protocol. In the year 1992, Consupren, the first, non-FDA approved, generic to Sandimmun was introduced. Although Consupren was not bioequivalent to Neoral, however, long-term results in kidney transplantation have been similar for both drugs. The introduction of Consupren resulted in a near 40% reduction in the total cost of immunosuppressive therapy. Interestingly the cost of the brand name drug Neoral was also reduced by 20%. The cost reduction allowed the introduction of the new immunosuppressive

On macroeconomic characteristics of pharmaceutical generics and the potential for manufacturing and consumption under fuzzy conditions.

Science.gov (United States)

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.

Analysis of site-specific dispersion conditions

International Nuclear Information System (INIS)

Paesler-Sauer, J.

1989-03-01

This report presents an analysis of atmospheric dispersion conditions in the environs of nuclear power stations in the Federal Republic of Germany. The analysis is based on meteorological data measured on the power station sites (KFUe = nuclear reactor remote control records) and by neighbouring stations operated by the German Weather Service. The data are series of hourly mean values of wind and temperature gradient or stability class over the period of one or more years. The aim of the data analysis is to find types of dispersion conditions characterized by the flow field and stratification, and to assess the feasibility of calculating these quantities in the case of an emergency. Influences of terrain structures in the environs of the site are considered. The annual frequencies of types of dispersion situations are assessed, the capability to recognize the dispersion situation from meteorological data measured on the site and the applicability of dispersion models are discussed. (orig.) [de

The generic article

NARCIS (Netherlands)

Farkas, D.F.; Swart, Henriëtte de

2005-01-01

We take a fresh look at the connection between genericity and (in)definiteness by reconsidering a long-standing puzzle concerning the relation between definiteness and genericity. We contrast English on the one hand and Romance languages and Hungarian on the other, focusing on generic sentences

LCA of contaminated site remediation - integration of site-specific impact assessment of local toxic impacts

DEFF Research Database (Denmark)

Lemming, Gitte; Hauschild, Michael Zwicky; Chambon, Julie Claire Claudia

2011-01-01

impacts have typically been assessed using site-generic characterization models representing a continental scale and excluding the groundwater compartment. Soil contaminants have therefore generally been assigned as emissions to surface soil or surface water compartments. However, such site-generic...... assessments poorly reflect the fate of frequent soil contaminants such as chloroethenes as they exclude the groundwater compartment and assume that the main part escapes to the atmosphere. Another important limitation of the generic impact assessment models is that they do not include the formation......The environmental impacts from remediation can be divided into primary and secondary impacts. Primary impacts cover the local impacts associated with the on-site contamination, whereas the secondary impacts are impacts on the local, regional and global scale generated by the remediation activities...

A Generic Danish Distribution Grid Model for Smart Grid Technology Testing

DEFF Research Database (Denmark)

Cha, Seung-Tae; Wu, Qiuwei; Østergaard, Jacob

2012-01-01

This paper describes the development of a generic Danish distribution grid model for smart grid technology testing based on the Bornholm power system. The frequency dependent network equivalent (FDNE) method has been used in order to accurately preserve the desired properties and characteristics...... as a generic Smart Grid benchmark model for testing purposes....... by comparing the transient response of the original Bornholm power system model and the developed generic model under significant fault conditions. The results clearly show that the equivalent generic distribution grid model retains the dynamic characteristics of the original system, and can be used...

Developing a generic environmental safety case

International Nuclear Information System (INIS)

Bailey, Lucy

2014-01-01

The Nuclear Decommissioning Authority (NDA) has been charged with implementing the United Kingdom government's policy for the long-term management of higher activity radioactive waste by planning, building and operating a geological disposal facility (GDF). Within the NDA, we - the Radioactive Waste Management Directorate (RWMD) - are tasked with the development of a GDF. The UK government has also decided that a process of voluntarism and partnership will be followed to identify a suitable site for the GDF. To date there is no volunteer community and the site selection process to find a volunteer host community is under review. RWMD has an ongoing role to provide advice to UK radioactive waste producers on the conditioning and packaging of wastes and to undertake disposability assessments of waste packaging proposals to determine their suitability for eventual disposal in a GDF. We also need to demonstrate our confidence that a GDF would be safe. Therefore RWMD has published a generic Environmental Safety Case (ESC) (NDA, 2010) to demonstrate that we are confident that a GDF could be developed to meet the guidelines set down by the environmental regulators (EA/NIEA, 2009) in a range of geological settings. The ESC includes reference case calculations that are used as a benchmark for disposability assessments. (author)

Sorption data bases for generic Swiss argillaceous rock systems

International Nuclear Information System (INIS)

Bradbury, M. H.; Baeyens, B.; Thoenen, T.

2010-09-01

In Switzerland the site selection procedure for both high level waste (HLW) and low and intermediate level waste (L/ILW) repositories is specified by the Swiss Federal Office of Energy in the Sectoral Plan for Deep Geological Repositories. In the forthcoming stage 2 of this plan, potential sites will be identified within regions previously selected based on the presence of suitable host rocks, namely Opalinus Clay, 'Brauner Dogger', Effingen Member and Helvetic Marl. Preliminary safety analyses are an integral part of this procedure, and require, amongst other information, the radionuclide sorption properties of the host rock. This report describes a methodology to develop a Generic Rock Sorption Data Base (GR-SDB) for argillaceous rocks. The method will be used to compile specific SDBs for the above mentioned host rocks. Arguments are presented that the main factor influencing sorption on argillaceous rocks is the phyllosilicate mineral content. These minerals are particularly effective at binding metals to their surfaces by cation exchange and surface complexation. Generally, the magnitude of sorption is directly correlated with the phyllosilicate content (2:1 type clays: illite/smectite/illitesmectite mixed layers), and this parameter best reflects the sorption potential of a given mineral assembly. Consequently, sorption measurements on illite were preferably used as source data for the GR-SDB. The second component influencing radionuclide sorption is the porewater chemistry. In the present report, generic water compositions were extracted from the analytical ranges of deep ground waters in various sedimentary formations in Switzerland. In order to cover the range of ionic strength (I) and pH values of Swiss ground waters in argillaceous rocks, five types of generic water compositions were defined, combining low, intermediate and high values of ionic strength and pH. The GR-SDB for in situ conditions was derived using conversion factors (CF). As the name

[Generic drugs: good or bad? Physician's knowledge of generic drugs and prescribing habits].

Science.gov (United States)

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.

Generic method for deriving the general shaking force balance conditions of parallel manipulators with application to a redundant planar 4-RRR parallel manipulator

NARCIS (Netherlands)

van der Wijk, V.; Krut, S.; Pierrot, F.; Herder, Justus Laurens

2011-01-01

This paper proposes a generic method for deriving the general shaking force balance conditions of parallel manipulators. Instead of considering the balancing of a parallel manipulator link-by-link or leg-by-leg, the architecture is considered altogether. The first step is to write the linear

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

Science.gov (United States)

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.

Study on Site Conditions Based on Topographic Slope

Science.gov (United States)

Wu, X.; Wang, X.; Yuan, X.; Chen, M.; Dou, A.

2018-04-01

The travel-time averaged shear-wave velocity to a depth of 30m (Vs30) below the Earth's surface is widely used to classify sites in many building codes. Vs30 is also used to estimate site classification in recent ground-motion prediction equations (GMPEs), and the distribution of Vs30 has been mapped in a region or country. An alternative method has recently been proposed for evaluating global seismic site conditions or Vs30, from the SRTM (Shuttle Radar Topography Mission) DEMs (digital elevation models). The basic premise of the method is that the topographic slope can be used as a reliable proxy for Vs30 in the absence of geologically and geotechnically based site-condition maps through correlations between Vs30 measurements and topographic gradient. Here, we use different resolutions (3 arcsec, 30 arcsec) DEM data to get Vs30 data separately, analyze and compare the difference of Vs30 data and site conditions obtained from different resolution DEM data. Shandong Province in eastern China and Sichuan Province in Western China are studied respectively. It is found that the higher resolution data is better at defining spatial topographic features than the 30c data, but less improvement in its correlation with Vs30.

STUDY ON SITE CONDITIONS BASED ON TOPOGRAPHIC SLOPE

Directory of Open Access Journals (Sweden)

X. Wu

2018-04-01

Full Text Available The travel-time averaged shear-wave velocity to a depth of 30m (Vs30 below the Earth’s surface is widely used to classify sites in many building codes. Vs30 is also used to estimate site classification in recent ground-motion prediction equations (GMPEs, and the distribution of Vs30 has been mapped in a region or country. An alternative method has recently been proposed for evaluating global seismic site conditions or Vs30, from the SRTM (Shuttle Radar Topography Mission DEMs (digital elevation models. The basic premise of the method is that the topographic slope can be used as a reliable proxy for Vs30 in the absence of geologically and geotechnically based site-condition maps through correlations between Vs30 measurements and topographic gradient. Here, we use different resolutions (3 arcsec, 30 arcsec DEM data to get Vs30 data separately, analyze and compare the difference of Vs30 data and site conditions obtained from different resolution DEM data. Shandong Province in eastern China and Sichuan Province in Western China are studied respectively. It is found that the higher resolution data is better at defining spatial topographic features than the 30c data, but less improvement in its correlation with Vs30.

Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

Science.gov (United States)

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 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.

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

Directory of Open Access Journals (Sweden)

Burwinkle Tasha M

2007-07-01

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

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

Science.gov (United States)

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

2007-07-16

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

Early Site Permit Demonstration Program: Siting Guide, Site selection and evaluation criteria for an early site permit application

International Nuclear Information System (INIS)

1993-01-01

In August 1991, the Joint Contractors came to agreement with Sandia National Laboratories (SNL) and the Department of Energy (DOE) on a workscope for the cost-shared Early Site Permit Demonstration Program. One task within the scope was the development of a guide for site selection criteria and procedures. A generic Siting Guide his been prepared that is a roadmap and tool for applicants to use developing detailed siting plans for their specific region of the country. The guide presents three fundamental principles that, if used, ensure a high degree of success for an ESP applicant. First, the site selection process should take into consideration environmentally diverse site locations within a given region of interest. Second, the process should contain appropriate opportunities for input from the public. Third, the process should be applied so that it is clearly reasonable to an impartial observer, based on appropriately selected criteria, including criteria which demonstrate that the site can host an advanced light water reactor (ALWR). The Siting Guide provides for a systematic, comprehensive site selection process in which three basic types of criteria (exclusionary, avoidance, and suitability) are presented via a four-step procedure. It provides a check list of the criteria for each one of these steps. Criteria are applied qualitatively, as well as presented numerically, within the guide. The applicant should use the generic guide as an exhaustive checklist, customizing the guide to his individual situation

Generic antibiotics in Japan.

Science.gov (United States)

Fujimura, Shigeru; Watanabe, Akira

2012-08-01

Generic drugs have been used extensively in many developed countries, although their use in Japan has been limited. Generic drugs reduce drug expenses and thereby national medical expenditure. Because generic drugs provide advantages for both public administration and consumers, it is expected that they will be more widely used in the future. However, the diffusion rate of generic drugs in Japan is quite low compared with that of other developed countries. An investigation on generic drugs conducted by the Ministry of Health, Labour and Welfare in Japan revealed that 17.2 % of doctors and 37.2 % of patients had not used generic drugs. The major reasons for this low use rate included distrust of off-patent products and lower drug price margin compared with the brand name drug. The generic drugs available in the market include external drugs such as wet packs, antihypertensive agents, analgesics, anticancer drugs, and antibiotics. Among them, antibiotics are frequently used in cases of acute infectious diseases. When the treatment of these infections is delayed, the infection might be aggravated rapidly. The pharmacokinetics-pharmacodynamics (PK-PD) theory has been adopted in recent chemotherapy, and in many cases, the most appropriate dosage and administration of antibiotics are determined for individual patients considering renal function; high-dosage antibiotics are used preferably for a short duration. Therefore, a highly detailed antimicrobial agent is necessary. However, some of the generic antibiotics have less antibacterial potency or solubility than the brand name products. We showed that the potency of the generic products of vancomycin and teicoplanin is lower than that of the branded drugs by 14.6 % and 17.3 %, respectively. Furthermore, we confirmed that a generic meropenem drug for injection required about 82 s to solubilize in saline, whereas the brand product required only about 21 s. It was thought that the cause may be the difference in size of bulk

Scripting XML with Generic Haskell

NARCIS (Netherlands)

Atanassow, F.; Clarke, D.; Jeuring, J.T.

2003-01-01

A generic program is written once and works on values of many data types. Generic Haskell is a recent extension of the functional programming language Haskell that supports generic programming. This paper discusses how Generic Haskell can be used to implement XML tools whose behaviour depends on

Scripting XML with Generic Haskell

NARCIS (Netherlands)

Atanassow, F.; Clarke, D.; Jeuring, J.T.

2007-01-01

A generic program is written once and works on values of many data types. Generic Haskell is a recent extension of the functional programming language Haskell that supports generic programming. This paper discusses how Generic Haskell can be used to implement XML tools whose behaviour depends on

Generic Site Safety Report

CERN Document Server

International Atomic Energy Agency. Vienna. ITER Joint Central Team

2001-01-01

The ITER Engineering Design Activities (EDA) are being conducted jointly by Euratom, Japan, and the Russian Federation, as Parties to the ITER EDA Agreement signed on 21 July 1992 and subsequently extended until July 20th 2001. (The United States of America was an ITER Party until September 30th 1999). The activities are conducted under the auspices of the IAEA by the ITER Joint Central Team and by the Home Teams (HT). The JCT is composed of qualified persons made available by each of the Parties in approximately equal numbers. The JCT members are located at the ITER Joint Work Sites (JWS) in Naka (Japan), Garching (Germany), and formerly in San Diego (USA). The Home Teams are established and organized by each Party for performing the tasks of the work programme for the EDA, assigned to them in approximately equal shares. Home Teams in each of the Parties perform specific design tasks, and perform research and development in technology (physics R&D is contributed voluntarily). The Home Team Leaders (HTL) ...

Early Site Permit Demonstration Program: Siting Guide, Site selection and evaluation criteria for an early site permit application. Revision 1

Energy Technology Data Exchange (ETDEWEB)

1993-03-24

In August 1991, the Joint Contractors came to agreement with Sandia National Laboratories (SNL) and the Department of Energy (DOE) on a workscope for the cost-shared Early Site Permit Demonstration Program. One task within the scope was the development of a guide for site selection criteria and procedures. A generic Siting Guide his been prepared that is a roadmap and tool for applicants to use developing detailed siting plans for their specific region of the country. The guide presents three fundamental principles that, if used, ensure a high degree of success for an ESP applicant. First, the site selection process should take into consideration environmentally diverse site locations within a given region of interest. Second, the process should contain appropriate opportunities for input from the public. Third, the process should be applied so that it is clearly reasonable to an impartial observer, based on appropriately selected criteria, including criteria which demonstrate that the site can host an advanced light water reactor (ALWR). The Siting Guide provides for a systematic, comprehensive site selection process in which three basic types of criteria (exclusionary, avoidance, and suitability) are presented via a four-step procedure. It provides a check list of the criteria for each one of these steps. Criteria are applied qualitatively, as well as presented numerically, within the guide. The applicant should use the generic guide as an exhaustive checklist, customizing the guide to his individual situation.

The Hanford Site generic component failure-rate database compared with other generic failure-rate databases

International Nuclear Information System (INIS)

Reardon, M.F.; Zentner, M.D.

1992-11-01

The Risk Assessment Technology Group, Westinghouse Hanford Company (WHC), has compiled a component failure rate database to be used during risk and reliability analysis of nonreactor facilities. Because site-specific data for the Hanford Site are generally not kept or not compiled in a usable form, the database was assembled using information from a variety of other established sources. Generally, the most conservative failure rates were chosen from the databases reviewed. The Hanford Site database has since been used extensively in fault tree modeling of many Hanford Site facilities and systems. The purpose of this study was to evaluate the reasonableness of the data chosen for the Hanford Site database by comparing the values chosen with the values from the other databases

Development and optimisation of generic decommissioning strategies for civil Magnox reactors

International Nuclear Information System (INIS)

Carpenter, G.; Hebditch, D.; Meek, N.; Patel, A.; Reeve, P.

2004-01-01

BNFL Environmental Services has formulated updated proposals for the use of decision analysis in the development of decommissioning strategy. The proposals are based on the Department of Transport, Local Government and the Regions manual for practitioners on multi-criteria analysis, specifically multi-criteria decision analysis, as suited to complex problems with a mixture of monetary and non-monetary objectives. They take account of up-to-date academic methodology, the newly issued BNFL decision analysis framework for environmental decisions and a wide variety of other engineering, optioneering and optimisation processes. The paper also summarises legislative and company policy areas of importance to decommissioning strategy development. Higher-level generic reactor and site remediation strategies already exist. At the lower level, various generic decommissioning reference processes and project options need development. For the past year, Environmental Services has held responsibility to respond to the Nuclear Installations Inspectorates' quinquennial review, develop and maintain up-to-date strategies, institute the review of a selected number of key strategies, and respond to changing circumstances including stakeholder views. Environmental Services is performing a range of generic studies for selection of strategies and end-points as used for a variety of waste management and site care and maintenance preparations. (author)

Generic, Extensible, Configurable Push-Pull Framework for Large-Scale Science Missions

Science.gov (United States)

Foster, Brian M.; Chang, Albert Y.; Freeborn, Dana J.; Crichton, Daniel J.; Woollard, David M.; Mattmann, Chris A.

2011-01-01

The push-pull framework was developed in hopes that an infrastructure would be created that could literally connect to any given remote site, and (given a set of restrictions) download files from that remote site based on those restrictions. The Cataloging and Archiving Service (CAS) has recently been re-architected and re-factored in its canonical services, including file management, workflow management, and resource management. Additionally, a generic CAS Crawling Framework was built based on motivation from Apache s open-source search engine project called Nutch. Nutch is an Apache effort to provide search engine services (akin to Google), including crawling, parsing, content analysis, and indexing. It has produced several stable software releases, and is currently used in production services at companies such as Yahoo, and at NASA's Planetary Data System. The CAS Crawling Framework supports many of the Nutch Crawler's generic services, including metadata extraction, crawling, and ingestion. However, one service that was not ported over from Nutch is a generic protocol layer service that allows the Nutch crawler to obtain content using protocol plug-ins that download content using implementations of remote protocols, such as HTTP, FTP, WinNT file system, HTTPS, etc. Such a generic protocol layer would greatly aid in the CAS Crawling Framework, as the layer would allow the framework to generically obtain content (i.e., data products) from remote sites using protocols such as FTP and others. Augmented with this capability, the Orbiting Carbon Observatory (OCO) and NPP (NPOESS Preparatory Project) Sounder PEATE (Product Evaluation and Analysis Tools Elements) would be provided with an infrastructure to support generic FTP-based pull access to remote data products, obviating the need for any specialized software outside of the context of their existing process control systems. This extensible configurable framework was created in Java, and allows the use of

Optimizing Generic Functions

NARCIS (Netherlands)

Alimarine, A.; Smetsers, J.E.W.

2004-01-01

Generic functions are defined by induction on the structural representation of types. As a consequence, by defining just a single generic operation, one acquires this operation over any particular type. An instance on a specific type is generated by interpretation of the type's structure. A direct

Generic Example Proving Criteria for All

Science.gov (United States)

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…

Automated analysis in generic groups

Science.gov (United States)

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

Implementation of IEC Generic Models of Type 1 Wind Turbine Generator in DIgSILENT PowerFactory

Institute of Scientific and Technical Information of China (English)

Haoran ZHAO; Qiuwei WU; Ioannis MARGARIS; Poul S(O)RENSEN

2013-01-01

The implementation method for the International Electrotechnical Commission (IEC) generic models of Type 1 wind turbine generator (WTG) in DIgSILENT PowerFactory is presented.The following items are described,i.e.model structure,model blocks and how to implement these blocks in the PowerFactory environment.Case studies under both normal and fault conditions are done with the implemented IEC generic models of Type 1 WTG,and dynamic responses are captured and analyzed.The case study results show that the IEC generic models of Type 1 WTG can correctly represent the performances of Type 1 WTG under both normal and fault conditions.

Application of the Spanish methodological approach for biosphere assessment to a generic high-level waste disposal site

International Nuclear Information System (INIS)

Agueero, A.; Pinedo, P.; Simon, I.; Cancio, D.; Moraleda, M.; Trueba, C.; Perez-Sanchez, D.

2008-01-01

A methodological approach which includes conceptual developments, methodological aspects and software tools have been developed in the Spanish context, based on the BIOMASS 'Reference Biospheres Methodology'. The biosphere assessments have to be undertaken with the aim of demonstrating compliance with principles and regulations established to limit the possible radiological impact of radioactive waste disposals on human health and on the environment, and to ensure that future generations will not be exposed to higher radiation levels than those that would be acceptable today. The biosphere in the context of high-level waste disposal is defined as the collection of various radionuclide transfer pathways that may result in releases into the surface environment, transport within and between the biosphere receptors, exposure of humans and biota, and the doses/risks associated with such exposures. The assessments need to take into account the complexity of the biosphere, the nature of the radionuclides released and the long timescales considered. It is also necessary to make assumptions related to the habits and lifestyle of the exposed population, human activities in the long term and possible modifications of the biosphere. A summary on the Spanish methodological approach for biosphere assessment are presented here as well as its application in a Spanish generic case study. A reference scenario has been developed based on current conditions at a site located in Central-West Spain, to indicate the potential impact to the actual population. In addition, environmental change has been considered qualitatively through the use of interaction matrices and transition diagrams. Unit source terms of 36 Cl, 79 Se, 99 Tc, 129 I, 135 Cs, 226 Ra, 231 Pa, 238 U, 237 Np and 239 Pu have been taken. Two exposure groups of infants and adults have been chosen for dose calculations. Results are presented and their robustness is evaluated through the use of uncertainty and sensitivity

Application of the Spanish methodological approach for biosphere assessment to a generic high-level waste disposal site.

Science.gov (United States)

Agüero, A; Pinedo, P; Simón, I; Cancio, D; Moraleda, M; Trueba, C; Pérez-Sánchez, D

2008-09-15

A methodological approach which includes conceptual developments, methodological aspects and software tools have been developed in the Spanish context, based on the BIOMASS "Reference Biospheres Methodology". The biosphere assessments have to be undertaken with the aim of demonstrating compliance with principles and regulations established to limit the possible radiological impact of radioactive waste disposals on human health and on the environment, and to ensure that future generations will not be exposed to higher radiation levels than those that would be acceptable today. The biosphere in the context of high-level waste disposal is defined as the collection of various radionuclide transfer pathways that may result in releases into the surface environment, transport within and between the biosphere receptors, exposure of humans and biota, and the doses/risks associated with such exposures. The assessments need to take into account the complexity of the biosphere, the nature of the radionuclides released and the long timescales considered. It is also necessary to make assumptions related to the habits and lifestyle of the exposed population, human activities in the long term and possible modifications of the biosphere. A summary on the Spanish methodological approach for biosphere assessment are presented here as well as its application in a Spanish generic case study. A reference scenario has been developed based on current conditions at a site located in Central-West Spain, to indicate the potential impact to the actual population. In addition, environmental change has been considered qualitatively through the use of interaction matrices and transition diagrams. Unit source terms of (36)Cl, (79)Se, (99)Tc, (129)I, (135)Cs, (226)Ra, (231)Pa, (238)U, (237)Np and (239)Pu have been taken. Two exposure groups of infants and adults have been chosen for dose calculations. Results are presented and their robustness is evaluated through the use of uncertainty and

Entrance C - Meyrin site: new access conditions

CERN Multimedia

2013-01-01

Entrance C on the Meyrin site, which drivers of motorised vehicles can use Mondays to Fridays from 7 a.m. to 9 a.m. and from 5 p.m. to 7 p.m., has been altered to include a turnstile to allow cyclists and pedestrians to use their access card to get in and out of the site from 6 a.m. until 10 p.m.   The following video illustrates how to use the new turnstile: A new type of entrance gate fitted with a number plate reader similar to that installed at the entrance to the Prévessin site should, once fully tested, allow drivers of motorised vehicles to access the site. For the time being, the conditions of use of Entrance C remain unchanged. Further information on the entry into force of new arrangements will be issued in due course. For further information about CERN entrances: CERN opening hours CERN control access GS Department

Encouraging generic use can yield significant savings.

Science.gov (United States)

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.

Consumers' views on generic medicines: a review of the literature.

Science.gov (United States)

Hassali, Mohamed A A; Shafie, Asrul A; Jamshed, Shazia; Ibrahim, Mohamed I M; Awaisu, Ahmed

2009-04-01

To review the literature on consumers' knowledge, attitudes and opinions of the use of generic medicines. A narrative review of studies conducted from 1970 to 2008 on consumers perceptions and views towards generic medicines was performed. An extensive literature search was undertaken using indexing services available at the authors' institution library. The following keywords were used for the search: brand, generic, multisource, medications, medicines, drugs, pharmaceuticals and consumers, customers, and patients. Electronic databases searched were Medline, Inside Web, ISI Web of Knowledge, Science Direct, Springer Link, JSTOR, Proquest, Ebsco Host and Google Scholar. These electronic databases were searched for full text papers published in English from 1970 to October 2008. Twenty studies were identified. Eleven were from the USA, four were from Europe, two were from Canada and one each was from Australia, Brazil and Malaysia. In general, consumers showed mixed reactions towards the use of generic medicines. This was evident from the divergence of views observed by country development level, consumers' socioeconomic characteristics, drug product characteristics, pharmaceutical reimbursement system, policy environment, contact with health care professionals, past experience with medications, and knowledge of the seriousness of a medical condition. Patient confidence and knowledge pertaining to generic medicines use have increased over the past four decades, especially in developed countries. Mass educational efforts, financial incentives, and greater communication among patients and health care professionals were seen as major drivers to the uptake of generic medicines among consumers.

Responsiveness of five condition-specific and generic outcome assessment instruments for chronic pain

Directory of Open Access Journals (Sweden)

Verra Martin L

2008-04-01

Full Text Available Abstract Background Changes of health and quality-of-life in chronic conditions are mostly small and require specific and sensitive instruments. The aim of this study was to determine and compare responsiveness, i.e. the sensitivity to change of five outcome instruments for effect measurement in chronic pain. Methods In a prospective cohort study, 273 chronic pain patients were assessed on the Numeric Rating Scale (NRS for pain, the Short Form 36 (SF-36, the Multidimensional Pain Inventory (MPI, the Hospital Anxiety and Depression Scale (HADS, and the Coping Strategies Questionnaire (CSQ. Responsiveness was quantified by effect size (ES and standardized response mean (SRM before and after a four week in-patient interdisciplinary pain program and compared by the modified Jacknife test. Results The MPI measured pain more responsively than the SF-36 (ES: 0.85 vs 0.72, p = 0.053; SRM: 0.72 vs 0.60, p = 0.027 and the pain NRS (ES: 0.85 vs 0.62, p Conclusion The MPI was most responsive in all comparable domains followed by the SF-36. The pain-specific MPI and the generic SF-36 can be recommended for comprehensive and specific bio-psycho-social effect measurement of health and quality-of-life in chronic pain.

76 FR 57767 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

Science.gov (United States)

2011-09-16

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for Operating Reactors AGENCY: Nuclear Regulatory Commission... FR 54507), that requested public comment on Draft NRC Generic Letter 2011- XX: Seismic Risk...

Acceptability and confidence in antiretroviral generics of physicians and HIV-infected patients in France.

Science.gov (United States)

Allavena, Clotilde; Jacomet, Christine; Pereira, Bruno; Morand-Joubert, Laurence; Bagheri, Haleh; Cotte, Laurent; Garaffo, Rodolphe; Gerbaud, Laurent; Dellamonica, Pierre

2014-01-01

sociodemographic conditions, HIV status or comorbidities had a constrictive influence on the use of ARV generics. Acceptability of ARV generics in this French population is mostly dictated by the patient's and physician's knowledge and use of generics overall. Switching ARV brand name to a generic would be better accepted if the pill burden remained unchanged.

Acyl transfer from membrane lipids to peptides is a generic process.

Science.gov (United States)

Dods, Robert H; Bechinger, Burkhard; Mosely, Jackie A; Sanderson, John M

2013-11-15

The generality of acyl transfer from phospholipids to membrane-active peptides has been probed using liquid chromatography-mass spectrometry analysis of peptide-lipid mixtures. The peptides examined include melittin, magainin II, PGLa, LAK1, LAK3 and penetratin. Peptides were added to liposomes with membrane lipid compositions ranging from pure phosphatidylcholine (PC) to mixtures of PC with phosphatidylethanolamine, phosphatidylserine or phosphatidylglycerol. Experiments were typically conducted at pH7.4 at modest salt concentrations (90 mM NaCl). In favorable cases, lipidated peptides were further characterized by tandem mass spectrometry methods to determine the sites of acylation. Melittin and magainin II were the most reactive peptides, with significant acyl transfer detected under all conditions and membrane compositions. Both peptides were lipidated at the N-terminus by transfer from PC, phosphatidylethanolamine, phosphatidylserine or phosphatidylglycerol, as well as at internal sites: lysine for melittin; serine and lysine for magainin II. Acyl transfer could be detected within 3h of melittin addition to negatively charged membranes. The other peptides were less reactive, but for each peptide, acylation was found to occur in at least one of the conditions examined. The data demonstrate that acyl transfer is a generic process for peptides bound to membranes composed of diacylglycerophospholipids. Phospholipid membranes cannot therefore be considered as chemically inert toward peptides and by extension proteins. © 2013. Published by Elsevier Ltd. All rights reserved.

Generics Pricing: The Greek Paradox.

Science.gov (United States)

Karafyllis, Ioannis; Variti, Lamprini

2017-01-01

This paper explains and develops a methodological framework to help evaluate the performance of generic pharmaceutical policies and the correct evaluation of generics sales. Until today erroneous recording of generics does not help proper pricing and their penetration in the Greek market. This classifies Greece on the outliners in every study or comparison that is referred on papers or studies.

NET 40 Generics Beginner's Guide

CERN Document Server

Mukherjee, Sudipta

2012-01-01

This is a concise, practical guide that will help you learn Generics in .NET, with lots of real world and fun-to-build examples and clear explanations. It is packed with screenshots to aid your understanding of the process. This book is aimed at beginners in Generics. It assumes some working knowledge of C# , but it isn't mandatory. The following would get the most use out of the book: Newbie C# developers struggling with Generics. Experienced C++ and Java Programmers who are migrating to C# and looking for an alternative to other generic frameworks like STL and JCF would find this book handy.

Efficient Generic Functional Programming

NARCIS (Netherlands)

Alimarine, A.; Smetsers, J.E.W.

2005-01-01

Generic functions are defined by induction on the structural representation of types. As a consequence, by defining just a single generic operation, one acquires this operation over any particular data type. An instance on a specific type is generated by interpretation of the type's structure. A

Generic robot architecture

Science.gov (United States)

Bruemmer, David J [Idaho Falls, ID; Few, Douglas A [Idaho Falls, ID

2010-09-21

The present invention provides methods, computer readable media, and apparatuses for a generic robot architecture providing a framework that is easily portable to a variety of robot platforms and is configured to provide hardware abstractions, abstractions for generic robot attributes, environment abstractions, and robot behaviors. The generic robot architecture includes a hardware abstraction level and a robot abstraction level. The hardware abstraction level is configured for developing hardware abstractions that define, monitor, and control hardware modules available on a robot platform. The robot abstraction level is configured for defining robot attributes and provides a software framework for building robot behaviors from the robot attributes. Each of the robot attributes includes hardware information from at least one hardware abstraction. In addition, each robot attribute is configured to substantially isolate the robot behaviors from the at least one hardware abstraction.

The site conditions of the Guo Shou Jing Telescope

International Nuclear Information System (INIS)

Yao Song; Liu Chao; Zhang Haotong; Deng Licai; Zhang Yueyang; Li Jing; Liu Nian; Zhou Xu; Gao Shuang; Xu Yan; Newberg, Heidi Jo; Carlin, Jeffrey L.; Chen Li; Hou Jinliang; Christlieb Norbert; Han Zhanwen; Lee, Hsu-Tai; Liu Xiaowei; Pan Kaike; Wang Hongchi

2012-01-01

The weather at the Xinglong Observing Station, where the Guo Shou Jing Telescope (GSJT) is located, is strongly affected by the monsoon climate in northeast China. The LAMOST survey strategy is constrained by these weather patterns. We present statistics on observing hours from 2004 to 2007, and the sky brightness, seeing, and sky transparency from 1995 to 2011 at the site. We investigate effects of the site conditions on the survey plan. Operable hours each month show a strong correlation with season: on average there are eight operable hours per night available in December, but only one—two hours in July and August. The seeing and the sky transparency also vary with season. Although the seeing is worse in windy winters, and the atmospheric extinction is worse in the spring and summer, the site is adequate for the proposed scientific program of the LAMOST survey. With a Monte Carlo simulation using historical data on the site condition, we find that the available observation hours constrain the survey footprint from 22 h to 16 h in right ascension; the sky brightness allows LAMOST to obtain a limiting magnitude of V = 19.5 mag with S/N=10.

42 CFR 447.506 - Authorized generic drugs.

Science.gov (United States)

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

Generic phytosanitary irradiation treatments

International Nuclear Information System (INIS)

Hallman, Guy J.

2012-01-01

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

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

Science.gov (United States)

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

International workshop on site investigation and evaluation based on the siting process in Sweden

International Nuclear Information System (INIS)

Andersson, Johan; Stroem, A.

2001-06-01

SKB's goal is to commence surface based site investigations in 2002. Extensive preparations are now being made for this transition to the next phase in the siting process for the deep repository for spent nuclear fuel. The purpose of the international workshop on site characterisation held at Aespoe April 2001 was to: present the SKB site investigation and evaluation programme to a group of international experts; discuss whether the available toolbox of investigation methods for surface based site investigations is appropriate and state-of-the-art in an international perspective; and by working group sessions discuss the level of ambition in the programme for site investigation for each discipline. This report summarises the conclusions of the workshop in general terms. Many of the detailed comments and ideas obtained at the workshop have already inspired and will also directly inspire the on-going planning work for site characterisation. The core activity at the workshop was the work performed by working groups. They addressed what should be considered for a site characterisation programme, based on the generic planning made so far by SKB. The working groups also outlined site specific characterisation programmes for the sites suggested by SKB. The tasks were strictly confined to technical and scientific modelling issues. The working group chairmen presented the working group results at the workshop and have also submitted short memos to SKB. The present document is a compilation of these memos. The SKB generic programme as presented in the existing top level documents, 'Requirements and Criteria and Overall Programme', received general endorsement and was appreciated for being comprehensive and systematic. For example, it contains comprehensive lists of parameters to be measured. However, there is need for prioritisation and sequencing. This is actually included in the current planning process at SKB where the generic programme later this year will be adapted to

Determinants of generic drug substitution in Switzerland

Directory of Open Access Journals (Sweden)

Lufkin Thomas M

2011-01-01

Full Text Available Abstract Background Since generic drugs have the same therapeutic effect as the original formulation but at generally lower costs, their use should be more heavily promoted. However, a considerable number of barriers to their wider use have been observed in many countries. The present study examines the influence of patients, physicians and certain characteristics of the generics' market on generic substitution in Switzerland. Methods We used reimbursement claims' data submitted to a large health insurer by insured individuals living in one of Switzerland's three linguistic regions during 2003. All dispensed drugs studied here were substitutable. The outcome (use of a generic or not was modelled by logistic regression, adjusted for patients' characteristics (gender, age, treatment complexity, substitution groups and with several variables describing reimbursement incentives (deductible, co-payments and the generics' market (prices, packaging, co-branded original, number of available generics, etc.. Results The overall generics' substitution rate for 173,212 dispensed prescriptions was 31%, though this varied considerably across cantons. Poor health status (older patients, complex treatments was associated with lower generic use. Higher rates were associated with higher out-of-pocket costs, greater price differences between the original and the generic, and with the number of generics on the market, while reformulation and repackaging were associated with lower rates. The substitution rate was 13% lower among hospital physicians. The adoption of the prescribing practices of the canton with the highest substitution rate would increase substitution in other cantons to as much as 26%. Conclusions Patient health status explained a part of the reluctance to substitute an original formulation by a generic. Economic incentives were efficient, but with a moderate global effect. The huge interregional differences indicated that prescribing behaviours and

Reassessment of selected factors affecting siting of Nuclear Power Plants

Energy Technology Data Exchange (ETDEWEB)

Davis, R.E.; Hanson, A.L.; Mubayi, V.; Nourbakhsh, H.P.

1997-02-01

Brookhaven National Laboratory has performed a series of probabilistic consequence assessment calculations for nuclear reactor siting. This study takes into account recent insights into severe accident source terms and examines consequences in a risk based format consistent with the quantitative health objectives (QHOs) of the NRC`s Safety Goal Policy. Simplified severe accident source terms developed in this study are based on the risk insights of NUREG-1150. The results of the study indicate that both the quantity of radioactivity released in a severe accident as well as the likelihood of a release are lower than those predicted in earlier studies. The accident risks using the simplified source terms are examined at a series of generic plant sites, that vary in population distribution, meteorological conditions, and exclusion area boundary distances. Sensitivity calculations are performed to evaluate the effects of emergency protective action assumptions on the risk of prompt fatality and latent cancers fatality, and population relocation. The study finds that based on the new source terms the prompt and latent fatality risks at all generic sites meet the QHOs of the NRC`s Safety Goal Policy by margins ranging from one to more than three orders of magnitude. 4 refs., 17 figs., 24 tabs.

Generic clearance values

International Nuclear Information System (INIS)

Bossio, M.C.; Muniz, C.C.

2009-01-01

This paper analyzes the Generic Clearance Values established for natural and artificial radionuclides with the objective of evaluating their degree of conservatism in views of adopting them into the regulatory body. Generic clearance values for natural radionuclides have been chosen by experts judgments as the optimum boundary between, on one hand, the ubiquitous unmodified soil concentrations and, on the other hand, activity concentrations in ores, mineral sands, industrial residues and wastes. For artificial radionuclides the clearance levels have been derived from the scenarios postulated in the document 'Safety Reports Series Nr 44' of the IAEA considering quantitative exemption criteria. A set of 8 scenarios were postulated covering external, ingestion and inhalation exposure pathways. For each radionuclide, the generic clearance level was derived as the more restrictive value obtained from the scenarios, that is the lowest ratio between the applicable individual dose and the dose per unit activity concentration (Bq/g). The individual dose was calculated by a formula depending on each scenario and pathway, with different parameters, such as exposure time, dosimetric factors, dilution factor, density of the material, geometric factors, etc. It was concluded that the basis and parameters used for the derivation of the generic clearance levels are quite conservative and therefore its the adoption in Argentina has been recommended. It is expected that their implementation will contribute to optimize the regulatory management system. (author)

Generic Clearance Values

International Nuclear Information System (INIS)

Bossio, M.C.; Muniz, C.C.

2010-01-01

This paper analyzes the Generic Clearance Values established for natural and artificial radionuclides with the objective of evaluating their degree of conservatism in views of adopting them into the regulatory body. Generic clearance values for natural radionuclides have been chosen by experts judgments as the optimum boundary between, on the one hand, the ubiquitous unmodified soil concentrations and, on the other hand, activity concentrations in ores, mineral sands, industrial residues and wastes. For artificial radionuclides the clearance levels have been derived from the scenarios postulated in the document Safety Reports Series 44 of the IAEA considering quantitative exemption criteria. A set of 8 scenarios were postulated covering external, ingestion and inhalation exposure pathways. For each radionuclide, the generic clearance level was derived as the more restrictive value obtained from the scenarios, that is the lowest ratio between the applicable individual dose and the dose per unit activity concentration (Bq/g). The individual dose was calculated by a formula depending on each scenario and pathway, with different parameters, such as exposure time, dosimetric factors, dilution factor, density of the material, geometric factors, etc. It was concluded that the basis and parameters used for the derivation of the generic clearance levels are quite conservative and therefore its the adoption in Argentina has been recommended. It is expected that their implementation will contribute to optimize the regulatory management system. (authors) [es

Generic phytosanitary irradiation treatments

Energy Technology Data Exchange (ETDEWEB)

Hallman, Guy J [United States Department of Agriculture, Agricultural Research Service, Weslaco, TX (United States)

2013-01-15

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

Generic phytosanitary irradiation treatments

Science.gov (United States)

Hallman, Guy J.

2012-07-01

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

Generic Crystalline Disposal Reference Case

Energy Technology Data Exchange (ETDEWEB)

Painter, Scott Leroy [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Chu, Shaoping [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Harp, Dylan Robert [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Perry, Frank Vinton [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Wang, Yifeng [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

2015-02-20

A generic reference case for disposal of spent nuclear fuel and high-level radioactive waste in crystalline rock is outlined. The generic cases are intended to support development of disposal system modeling capability by establishing relevant baseline conditions and parameters. Establishment of a generic reference case requires that the emplacement concept, waste inventory, waste form, waste package, backfill/buffer properties, EBS failure scenarios, host rock properties, and biosphere be specified. The focus in this report is on those elements that are unique to crystalline disposal, especially the geosphere representation. Three emplacement concepts are suggested for further analyses: a waste packages containing 4 PWR assemblies emplaced in boreholes in the floors of tunnels (KBS-3 concept), a 12-assembly waste package emplaced in tunnels, and a 32-assembly dual purpose canister emplaced in tunnels. In addition, three failure scenarios were suggested for future use: a nominal scenario involving corrosion of the waste package in the tunnel emplacement concepts, a manufacturing defect scenario applicable to the KBS-3 concept, and a disruptive glaciation scenario applicable to both emplacement concepts. The computational approaches required to analyze EBS failure and transport processes in a crystalline rock repository are similar to those of argillite/shale, with the most significant difference being that the EBS in a crystalline rock repository will likely experience highly heterogeneous flow rates, which should be represented in the model. The computational approaches required to analyze radionuclide transport in the natural system are very different because of the highly channelized nature of fracture flow. Computational workflows tailored to crystalline rock based on discrete transport pathways extracted from discrete fracture network models are recommended.

Generic Advantages

Indian Academy of Sciences (India)

First page Back Continue Last page Overview Graphics. Generic Advantages. Scalability an incremental coverage. Standardization. Business Plan Flexibility. Lifecycle Flexibility. Reliability. Service Interoperability. Changed Industry dynamics.

77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

Science.gov (United States)

2012-08-27

... generic drugs program. GDUFA will also significantly improve global supply chain transparency by requiring... promote global supply chain transparency. The information provided through self-identification will enable... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD...

Generic penetration in the retail antidepressant market.

Science.gov (United States)

Ventimiglia, Jeffrey; Kalali, Amir H

2010-06-01

In this article, we explore the accelerated penetration of generic antidepressants in the United States market following the availability of generic citalopram and sertraline. Analysis suggests that overall, generic penetration into the antidepressant market has grown from approximately 41 percent in January 2004 to over 73 percent in January 2010. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

A cross-sectional survey of pharmacists to understand their personal preference of brand and generic over-the-counter medications used to treat common health conditions.

Science.gov (United States)

Patel, Mira; Slack, Marion; Cooley, Janet; Bhattacharjee, Sandipan

2016-01-01

Consumers are hesitant in choosing generic medications as they are under the assumption that they are not as safe nor effective as brand medications. However, pharmacists do have the education and training to know that this is not the case. The aim of this study was to determine pharmacists' preference of generic versus brand over-the-counter (OTC) medication for their personal use as self-treatment for various health symptoms. A prospective, cross sectional study was conducted on 553 licensed pharmacists who were presumed to have expertise in the use of generic and brand name OTC medications. In a single Southwestern state in the United States, from December 2014 to January 2015, a web-based questionnaire was sent to pharmacists to explore their preference of brand and generic medications based on various health symptoms. Thirty-one brand-generic medication pairs were used to identify which medication type pharmacists preferred when asked about nine health symptoms. Frequency counts of pharmacists' preference of a brand medication or a generic OTC medication overall and for each of the nine health symptoms were determined. Chi-squared analyses and one-way ANOVA were conducted to determine if there were any differences between the preferences of brand and generic OTC medications across each symptom. The study overall showed that pharmacists preferred generic OTC medications to brand OTC medications (62 to 5 %, respectively). Based on an 11-point rating scale, pharmacists were likely to take OTC generic medications (as their choice of self-treatment) when presented with health symptoms (mean = 7.32 ± 2.88). In addition, pharmacists chose generic OTC medications over brand medications regardless of health symptoms (p brand name OTC medications for self-treating a variety of health symptoms. These study findings support the theory that expertise affects preference for generic versus brand name OTC medications. This information can be used to provide

Rethinking generic skills

Directory of Open Access Journals (Sweden)

Roy Canning

2013-10-01

Full Text Available The paper provides a critical analysis of the notion of generic or transversal skillscontained with European Union policy discourses. The author presents a conceptualframework that challenges the idea that generic skills are universal, transferable andautonomous. An alternative analysis is put forward that argues the case forcontextualising skills and knowledge within particular understandings and cultures thatare more collective than individualistic in nature. The arguments are framed withinwider cross-disciplinary debates in linguistics, geosemiotics and social-cultural theoryand build upon an earlier paper exploring core skills in the UK (Canning, 2007.

Quality of generic medicines in South Africa

DEFF Research Database (Denmark)

Patel, Aarti; Gauld, Robin; Norris, Pauline

2012-01-01

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 ...

A Site Wide Perspective on Uranium Geochemistry at the Hanford Site

Energy Technology Data Exchange (ETDEWEB)

Zachara, John M.; Brown, Christopher F.; Christensen, J. N.; Davis, Jim A.; Dresel, P. Evan; Liu, Chongxuan; Kelly, S. D.; McKinley, James P.; Serne, R. Jeffrey; Um, Wooyong

2007-10-26

Uranium (U) is an important risk-driving contaminant at the Hanford Site. Over 200,000 kg have been released to the vadose zone over the course of site operations, and a number of vadose zone and groundwater plumes containing the uranyl cation [UO22+, U(VI)] have been identified. U is recognized to be of moderate-to-high mobility, conditions dependent. The site is currently making decisions on several of these plumes with long-lasting implications, and others are soon to come. Uranium is one of nature’s most intriguing and chemically complex elements. The fate and transport of U(VI) has been studied over the long lifetime of the Hanford Site by various contractors, along with the Pacific Northwest National Laboratory (PNNL) and its collaborators. Significant research has more recently been contributed by the national scientific community with support from the U.S. Department of Energy’s (DOE) Office of Science through its Environmental Remediation Sciences Division (ERSD). This report represents a first attempt to integrate these findings into a cohesive view of the subsurface geochemistry of U at the Hanford Site. The objective is to inform all interested Hanford parties about the in-ground inventory of U and its geochemical behavior. This report also comments on the prospects for the development of a robust generic model to more accurately forecast future U(VI) migration at different Hanford waste sites, along with further research necessary to reach this goal.

Perception of antiretroviral generic medicines: one-day survey of HIV-infected patients and their physicians in France.

Science.gov (United States)

Jacomet, Christine; Allavena, Clotilde; Peyrol, Fleur; Pereira, Bruno; Joubert, Laurence Morand; Bagheri, Haleh; Cotte, Laurent; Garaffo, Rodolphe; Gerbaud, Laurent; Dellamonica, Pierre

2015-01-01

In the interest of cost effectiveness, switching antiretroviral brand name medications to generics is recommended in France since 2013. The study objective was to evaluate the perception of generics per se and antiretroviral generics in HIV-infected patients and their hospital physicians. 556 out of 703 (79%) adult HIV+ outpatients and 116 physicians in 33 clinics were included in a multicentric cross-sectional survey performed in September 2013. Patients completed a self-questionnaire on their perception and acceptability of generics. Physicians completed a questionnaire on their acceptability of switching antiretroviral to generic. Socio-demographic data, medical history and HIV history were collected. Among the 556 patients with a median HIV duration of 13 years, 77% were France native, 59% in active employment, 100% covered by social insurance, 95% on antiretroviral therapy. Seventy-six percent of the patients accepted generics and 55% trusted them overall. Antiretroviral generics were accepted by 44% of them but only by 17% if the pill burden was going to increase. The factor significantly associated with acceptability of antiretroviral generics was acceptance of generics per se (pantiretroviral generics were the absence of concern regarding the chemical entity (OR = 0.33), being aware that the patient would accept generics for other pathologies (OR = 2.04) and would accept antiretroviral generics (OR = 1.94). No factor related to sociodemographic conditions, HIV status or comorbidities was associated with the acceptability of antiretroviral generics. Acceptability of antiretroviral generics in this French population was mostly dictated by the patient's and physician's knowledge and use of generics overall. It should be improved with an efficient information of both patients and physicians.

Perception of Antiretroviral Generic Medicines: One-Day Survey of HIV-Infected Patients and Their Physicians in France

Science.gov (United States)

Jacomet, Christine; Allavena, Clotilde; Peyrol, Fleur; Pereira, Bruno; Joubert, Laurence Morand; Bagheri, Haleh; Cotte, Laurent; Garaffo, Rodolphe; Gerbaud, Laurent; Dellamonica, Pierre

2015-01-01

Background In the interest of cost effectiveness, switching antiretroviral brand name medications to generics is recommended in France since 2013. The study objective was to evaluate the perception of generics per se and antiretroviral generics in HIV-infected patients and their hospital physicians Methods and Findings 556 out of 703 (79%) adult HIV+ outpatients and 116 physicians in 33 clinics were included in a multicentric cross-sectional survey performed in September 2013. Patients completed a self-questionnaire on their perception and acceptability of generics. Physicians completed a questionnaire on their acceptability of switching antiretroviral to generic. Socio-demographic data, medical history and HIV history were collected. Among the 556 patients with a median HIV duration of 13 years, 77% were France native, 59% in active employment, 100% covered by social insurance, 95% on antiretroviral therapy. Seventy-six percent of the patients accepted generics and 55% trusted them overall. Antiretroviral generics were accepted by 44% of them but only by 17% if the pill burden was going to increase. The factor significantly associated with acceptability of antiretroviral generics was acceptance of generics per se (pantiretroviral generics were the absence of concern regarding the chemical entity (OR = 0.33), being aware that the patient would accept generics for other pathologies (OR = 2.04) and would accept antiretroviral generics (OR = 1.94). No factor related to sociodemographic conditions, HIV status or comorbidities was associated with the acceptability of antiretroviral generics. Conclusions Acceptability of antiretroviral generics in this French population was mostly dictated by the patient’s and physician’s knowledge and use of generics overall. It should be improved with an efficient information of both patients and physicians. PMID:25658627

Generic environmental impact statement for license renewal of nuclear plants. Final report

International Nuclear Information System (INIS)

1996-05-01

This GEIS examines the possible environmental impacts that could occur as a result of renewing the licenses of individual nuclear power plants under 10 CFR 54. To the extent possible, it establishes the bounds and significance of these potential impacts. The analysis encompasses all operating light-water reactors. For each type of environmental impact, the GEIS attempts to establish generic findings covering as many plants as possible. While plant and site-specific information is used in developing the generic findings, the NRC does not intend for the GEIS to be a compilation of individual plant environmental impacts statements. This document has three principal objectives: (1) to provide an understanding of the types and severity of environmental impacts that may occur as a result of license renewal, (2) to identify and assess those impacts that are expected to be generic to license renewal, and (3) to support rulemaking (10 CFR 51) to define the number and scope of issues that need to be addressed by the applicants in plant-by-plant license renewal proceedings

Exploring knowledge, perceptions and attitudes about generic ...

African Journals Online (AJOL)

Exploring knowledge, perceptions and attitudes about generic medicines among final-year health science students. ... had knowledge deficits about the safety, quality and efficacy of generic medicines. The dissemination of information about generic medicines may strengthen future knowledge, attitudes and perceptions.

Generic medicines: solutions for a sustainable drug market?

Science.gov (United States)

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

2013-10-01

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

Generic medicines: Perceptions of Physicians in Basrah, Iraq

Directory of Open Access Journals (Sweden)

Adheed Khalid Sharrad

2009-08-01

Full Text Available BackgroundThe use of cheaper generic medicines is a strategy promotedin many countries to reduce rising health care costs. The aimof this study was to explore factors affecting generic medicineprescribing by physicians in Basrah, Iraq.MethodologyA purposive sample of ten physicians practicing in Basrahwas interviewed using a semi-structured interview guide.ResultsAnalysis of the interviews identified seven major themes:medicine prescribing practice, knowledge of therapeuticequivalency of generic medicine, patients’ acceptance ofgeneric medicine, counterfeit medicine, drug informationsource and effect of drug advertising on medicines choice,brand substitution practice by community pharmacists, and,finally strategies to improve generic medicine usefulness.Participants identified helpful strategies to increase genericprescribing including; physician and patient education ongeneric medicine; persuading physicians about the safety andefficacy of generic medicines; and finally educating seniormedical students on generic prescribing.ConclusionThe data suggest that participants were enthusiasticabout prescribing generic medicines. However physiciansinsist that pharmacists should not be allowed tosubstitute generic drugs without prior approval ofdoctors.

Perception of antiretroviral generic medicines: one-day survey of HIV-infected patients and their physicians in France.

Directory of Open Access Journals (Sweden)

Christine Jacomet

Full Text Available In the interest of cost effectiveness, switching antiretroviral brand name medications to generics is recommended in France since 2013. The study objective was to evaluate the perception of generics per se and antiretroviral generics in HIV-infected patients and their hospital physicians.556 out of 703 (79% adult HIV+ outpatients and 116 physicians in 33 clinics were included in a multicentric cross-sectional survey performed in September 2013. Patients completed a self-questionnaire on their perception and acceptability of generics. Physicians completed a questionnaire on their acceptability of switching antiretroviral to generic. Socio-demographic data, medical history and HIV history were collected. Among the 556 patients with a median HIV duration of 13 years, 77% were France native, 59% in active employment, 100% covered by social insurance, 95% on antiretroviral therapy. Seventy-six percent of the patients accepted generics and 55% trusted them overall. Antiretroviral generics were accepted by 44% of them but only by 17% if the pill burden was going to increase. The factor significantly associated with acceptability of antiretroviral generics was acceptance of generics per se (p<0.001. Among the 116 physicians following a median of 100 HIV-patients/year, 75% would prescribe generics, dropping to 26% if the combo had to be broken. Factors significantly associated with willingness to prescribe antiretroviral generics were the absence of concern regarding the chemical entity (OR = 0.33, being aware that the patient would accept generics for other pathologies (OR = 2.04 and would accept antiretroviral generics (OR = 1.94. No factor related to sociodemographic conditions, HIV status or comorbidities was associated with the acceptability of antiretroviral generics.Acceptability of antiretroviral generics in this French population was mostly dictated by the patient's and physician's knowledge and use of generics overall. It should be improved

Request for information related to the resolution of generic issue 130, ''Essential service water system failures at multi-unit sites,'' pursuant to 10 CFR 50.54(f) - Generic Letter 91-13

International Nuclear Information System (INIS)

Partlow, J.G.

1993-01-01

The essential service water system (ESWS) is important in maintaining plant safety during power operation, shutdown, and accident conditions. As part of the Nuclear Regulatory Commission's (NRC) evaluation of loss of essential service water (LOSW), extensive analyses of this issue were performed at the Brookhaven National Laboratory (BNL). In addition, the NRC staff performed a regulatory analysis to evaluate the safety benefits and implementation costs associated with various equipment and the administrative-type improvements that were considered. These analyses assume that the flushing and flow testing provisions of Generic Letter (GL) 89-13, ''Service Water System Problems Affecting Safety-Related Equipment,'' will be applied to the crosstie lines as part of addressees' implementation of the resolution of GI-51, ''Improving the Reliability of Open-Cycle Service Water Systems'' (GL 89-13 and Supplement 1). On the basis of results of these evaluations of this generic safety issue, the NRC staff has concluded that the following administrative-type improvements would significantly enhance the availability of the ESWS in affected plants, and their implementation is warranted in view of the safety benefit to be derived and the cost of implementation: technical specification (TS) changes contained in Enclosure 1 to enhance the availability of the ESWS as applied to the design configuration of affected plants; and improvement of emergency procedures for a LOSW using existing design features, specifically: (a) operating and maintaining high-pressure injection (HPI) pump integrity in the event of loss of reactor coolant pump (RCP) seals as a result of ESWS failure, and (b) testing and manipulating the ESWS crosstie between the units during a LOSW accident

Comparing approaches to generic programming in Haskell

NARCIS (Netherlands)

Hinze, R.; Jeuring, J.T.; Löh, A.

2006-01-01

The last decade has seen a number of approaches to generic programming: PolyP, Functorial ML, `Scrap Your Boilerplate', Generic Haskell, `Generics for the Masses', etc. The approaches vary in sophistication and target audience: some propose full-blown pro- gramming languages, some suggest

Generic Switching and Non-Persistence among Medicine Users

DEFF Research Database (Denmark)

Østergaard Rathe, Jette; Andersen, Morten; Jarbøl, Dorte Ejg

2015-01-01

BACKGROUND: Generic substitution means that one medicinal product is replaced by another product containing the same active substance. It is strictly regulated with respect to its bioequivalence, and all products must have undergone appropriate studies. Although generic substitution is widely...... implemented, it still remains to be answered how generic switch influences persistence to long-term treatment, and if it is modified by patients' concerns about medicine and views on generic medicine. This study focuses on users of antidepressants and antiepileptics, and their experience of generic switching....... METHODS: The study was an observational cohort study. By use of a prescription database, we identified patients who had redeemed prescriptions on generically substitutable drugs, and a questionnaire was mailed to them. We analyzed predictors of discontinuation in relation to generic switch and patients...

Article choice in plural generics

NARCIS (Netherlands)

Farkas, D.F.; Swart, Henriëtte de

2007-01-01

We discuss two groups of languages where article use contrasts in generic plural sentences but is otherwise essentially similar. The languages in the first group (English and Dutch) use bare plurals in the expression of kind reference (‘Dinosaurs are extinct’) and in generic

40 CFR 721.9973 - Zirconium dichlorides (generic).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Zirconium dichlorides (generic). 721... Substances § 721.9973 Zirconium dichlorides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as zirconium dichlorides (PMNs P...

Comparing approaches to generic programming in Haskell

NARCIS (Netherlands)

Hinze, R.; Jeuring, J.T.; Löh, A.

2006-01-01

The last decade has seen a number of approaches to data- type-generic programming: PolyP, Functorial ML, `Scrap Your Boiler- plate', Generic Haskell, `Generics for the Masses', etc. The approaches vary in sophistication and target audience: some propose full-blown pro- gramming languages, some

Generic conditions for suppressing the coherent synchrotron radiation induced emittance growth in a two-dipole achromat

Science.gov (United States)

Jiao, Yi; Cui, Xiaohao; Huang, Xiyang; Xu, Gang

2014-06-01

The effect of the coherent synchrotron radiation (CSR) becomes evident, and leads to increased beam energy spread and transverse emittance dilution, as both the emittance and bunch length of the electron beams are continuously pushed down in present and forthcoming high-brightness light sources and linear colliders. Suppressing this effect is important to preserve the expected machine performance. Methods of the R-matrix analysis and the Courant-Snyder formalism analysis have been proposed to evaluate and to suppress the emittance growth due to CSR in achromatic cells. In this paper a few important modifications are made on these two methods, which enable us to prove that these two methods are equivalent to each other. With the modified analysis, we obtain explicit and generic conditions of cancelling the CSR-driven emittance excitation in a single achromat consisting of two dipoles of arbitrary bending angles. In spite of the fact that the analysis constrains itself in a linear regime, based on the assumption that CSR-induced particle energy deviation is proportional to both θ and ρ1/3, with θ being the bending angle and ρ the bending radius, it is demonstrated through ELEGANT simulations that the conditions derived from this analysis are still effective in suppressing the emittance growth when a more detailed one-dimensional CSR model is considered. In addition, it illustrates that the emittance growth can be reduced to a lower level with the proposed conditions than with the other two approaches, such as matching the beam envelope to the CSR kick and setting the cell-to-cell betatron phase advance to an appropriate value.

40 CFR 721.9959 - Polyurethane polymer (generic).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Polyurethane polymer (generic). 721... Substances § 721.9959 Polyurethane polymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a polyurethane polymer (PMN P-01...

Proceedings Workshop on Generic Programming (WGP2000)

NARCIS (Netherlands)

Jeuring, J.T.

2000-01-01

This report contains the papers selected for presentation at the 2nd Workshop on Generic Programming (WGP2000), which was held on July 6, 2000 in Ponte de Lima, Portugal. Generic programming is about making programs more adaptable by making them more general. Generic programs often embody

Skin rash during treatment with generic itraconazole.

Science.gov (United States)

De Vuono, Antonio; Palleria, Caterina; Scicchitano, Francesca; Squillace, Aida; De Sarro, Giovambattista; Gallelli, Luca

2014-04-01

Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re-challenge confirmed the association between itraconazole and skin rash. Both Naranjo probability scale and World Health Organization causality assessment scale documented a probable association between generic-itraconazole and skin rash. The switch from generic formulation to brand one induced an improvement of symptoms. Since we are unable to evaluate the role of each excipient in the development of skin rash, we cannot rule out their involvement. However, more data are necessary to better define the similarities or differences between branded and generic formulations.

Generic Argillite/Shale Disposal Reference Case

Energy Technology Data Exchange (ETDEWEB)

Zheng, Liange; Colon, Carlos Jové; Bianchi, Marco; Birkholzer, Jens

2014-08-08

Radioactive waste disposal in a deep subsurface repository hosted in clay/shale/argillite is a subject of widespread interest given the desirable isolation properties, geochemically reduced conditions, and widespread geologic occurrence of this rock type (Hansen 2010; Bianchi et al. 2013). Bianchi et al. (2013) provides a description of diffusion in a clay-hosted repository based on single-phase flow and full saturation using parametric data from documented studies in Europe (e.g., ANDRA 2005). The predominance of diffusive transport and sorption phenomena in this clay media are key attributes to impede radionuclide mobility making clay rock formations target sites for disposal of high-level radioactive waste. The reports by Hansen et al. (2010) and those from numerous studies in clay-hosted underground research laboratories (URLs) in Belgium, France and Switzerland outline the extensive scientific knowledge obtained to assess long-term clay/shale/argillite repository isolation performance of nuclear waste. In the past several years under the UFDC, various kinds of models have been developed for argillite repository to demonstrate the model capability, understand the spatial and temporal alteration of the repository, and evaluate different scenarios. These models include the coupled Thermal-Hydrological-Mechanical (THM) and Thermal-Hydrological-Mechanical-Chemical (THMC) models (e.g. Liu et al. 2013; Rutqvist et al. 2014a, Zheng et al. 2014a) that focus on THMC processes in the Engineered Barrier System (EBS) bentonite and argillite host hock, the large scale hydrogeologic model (Bianchi et al. 2014) that investigates the hydraulic connection between an emplacement drift and surrounding hydrogeological units, and Disposal Systems Evaluation Framework (DSEF) models (Greenberg et al. 2013) that evaluate thermal evolution in the host rock approximated as a thermal conduction process to facilitate the analysis of design options. However, the assumptions and the

Is bioavailability altered in generic versus brand anticonvulsants?

Science.gov (United States)

Jankovic, Slobodan M; Ignjatovic Ristic, Dragana

2015-03-01

Therapeutic window of anticonvulsants is not a wide one, with phenytoin being one extreme, which can be classified as a narrow therapeutic index drug, since its ratio between the least toxic and the least effective concentration is less than twofold. In order to obtain marketing authorization, a generic anticonvulsant should demonstrate relative bioequivalence with its brand-name counterpart. However, although bioequivalent, generic anticonvulsants still do not have the same bioavailability as brand-name drugs, which may lead to larger fluctuations of steady-state plasma concentrations, and sometimes to loss of seizure control if a patient is switched from brand-name to generic or from generic to generic anticonvulsant. Generic anticonvulsants are effective, safe and affordable drugs for treatment of epilepsy, and patients could be successfully treated with them from the very beginning. It is switching from brand-name to generic anticonvulsant or from one generic anticonvulsant to another that should be avoided in clinical practice, since subtle differences in bioavailability may disturb optimal degree of seizure control to which the patient was previously successfully titrated.

A multicenter experience with generic tacrolimus conversion.

Science.gov (United States)

McDevitt-Potter, Lisa M; Sadaka, Basma; Tichy, Eric M; Rogers, Christin C; Gabardi, Steven

2011-09-27

The first generic tacrolimus product gained Food and Drug Administration approval in August 2009. This prospective, observational trial sought to determine the need for dose titrations and measure drug cost savings on conversion to generic tacrolimus. Transplant recipients on stable tacrolimus doses were converted from brand to generic tacrolimus on a mg:mg basis. Data were collected at the time of generic conversion (study arm) and at a time point exactly 6 months before conversion (control arm) for all subjects. Seventy conversions from four centers are reported. Subjects were a mean of 70 months after kidney (n=37), liver (n=28), or multiorgan (n=5) transplant. In the study arm, mean tacrolimus doses were 4.4 and 4.5 mg/d and mean tacrolimus trough concentrations were 5.8 and 5.9 ng/mL before and after conversion, respectively. In the control arm, mean tacrolimus doses were 4.6 and 4.6 mg/d and mean tacrolimus trough concentrations were 6.1 and 5.9 ng/mL before and after the control time point, respectively. Dose titrations occurred in five patients (7%) in the control arm and 15 patients (21%) in the study arm (P=0.028). Mean monthly drug costs were $645 for brand, $593 for generic, and $595 for generic after dose titrations. Mean monthly patient copays were $38 for brand and $15 for generic. These cumulative data show that dose requirements and trough levels are similar between brand and generic tacrolimus and that generic substitution allows for savings. However, postconversion monitoring is prudent as patients may require dose titration.

Brand loyalty, patients and limited generic medicines uptake.

Science.gov (United States)

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.

From Site Data to Safety Assessment: Analysis of Present and Future Hydrological Conditions at a Coastal Site in Sweden

International Nuclear Information System (INIS)

Berglund, Sten; Bosson, Emma; Sassner, Mona

2013-01-01

This paper presents an analysis of present and future hydrological conditions at the Forsmark site in Sweden, which has been proposed as the site for a geological repository for spent nuclear fuel. Forsmark is a coastal site that changes in response to shoreline displacement. In the considered time frame (until year 10 000 ad), the hydrological system will be affected by landscape succession associated with shoreline displacement and changes in vegetation, regolith stratigraphy, and climate. Based on extensive site investigations and modeling of present hydrological conditions, the effects of different processes on future site hydrology are quantified. As expected, shoreline displacement has a strong effect on local hydrology (e.g., groundwater flow) in areas that change from sea to land. The comparison between present and future land areas emphasizes the importance of climate variables relative to other factors for main hydrological features such as water balances

Influencers of generic drug utilization: A systematic review.

Science.gov (United States)

Howard, Jennifer N; Harris, Ilene; Frank, Gavriella; Kiptanui, Zippora; Qian, Jingjing; Hansen, Richard

2017-08-04

With an increase in prescription drug spending and rising drug costs there is a need to encourage the use of generic prescription drugs. However, maximizing generic drug use is not possible without the public's positive perception and meeting their informational needs about generic drugs. Thus, improving the public's confidence in, and knowledge of generic drugs on the market is critical. The objective of this systematic review is to examine and evaluate the studies focusing on the nature and extent of key factors influencing generic drug use in the United States in order to help guide policy, education and practice interventions. Using multiple search engines and key word screening criteria, empirical studies published in English between January 1, 2005 and December 31, 2015 were identified. A qualitative synthesis of the evidence identified domains of key factors that influenced generic drug use across studies. Over 3000 citations met the key word screening criteria; 67 of these met inclusion criteria for the systematic review. Seven domains of factors that influence generic drug utilization were identified: 1) patient-related factors, 2) formulary management or cost containment, 3) healthcare policies, 4) promotional activities, 5) educational initiatives, 6) technology, and 7) physician-related factors. Patients, physicians, pharmacists, formulary managers, and policymakers play an important role in generic drug use. Understanding the factors influencing generic drug use can help guide future policy, education, and practice interventions to increase generic drug use. Copyright © 2017 Elsevier Inc. All rights reserved.

Generic superweak chaos induced by Hall effect

Science.gov (United States)

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.

Generic domain models in software engineering

Science.gov (United States)

Maiden, Neil

1992-01-01

This paper outlines three research directions related to domain-specific software development: (1) reuse of generic models for domain-specific software development; (2) empirical evidence to determine these generic models, namely elicitation of mental knowledge schema possessed by expert software developers; and (3) exploitation of generic domain models to assist modelling of specific applications. It focuses on knowledge acquisition for domain-specific software development, with emphasis on tool support for the most important phases of software development.

TRANSIT: model for providing generic transportation input for preliminary siting analysis

International Nuclear Information System (INIS)

McNair, G.W.; Cashwell, J.W.

1985-02-01

To assist the US Department of Energy's efforts in potential facility site screening in the nuclear waste management program, a computerized model, TRANSIT, is being developed. Utilizing existing data on the location and inventory characteristics of spent nuclear fuel at reactor sites, TRANSIT derives isopleths of transportation mileage, costs, risks and fleet requirements for shipments to storage sites and/or repository sites. This technique provides a graphic, first-order method for use by the Department in future site screening efforts. 2 refs

Site-specific variability in BTEX biodegradation under denitrifying conditions

International Nuclear Information System (INIS)

Kao, C.M.; Borden, R.C.

1997-01-01

Laboratory microcosm experiments were conducted to evaluate the feasibility of benzene, toluene, ethylbenzene, m-xylene, and o-xylene (BTEX) biodegradation under denitrifying conditions. Nine different sources of inocula, including contaminated and uncontaminated soil cores from four different sites and activated sludge, were used to establish microcosms. BTEX was not degraded under denitrifying conditions in microcosms inoculated with aquifer material from Rocky Point and Traverse City. However, rapid depletion of glucose under denitrifying conditions was observed in microcosms containing Rocky Point aquifer material. TEX degradation was observed in microcosms containing Rocky Point aquifer material. TEX degradation was observed in microcosms containing aquifer material from Fort Bragg and Sleeping Bear Dunes and sewage sludge. Benzene was recalcitrant in all microcosms tested. The degradation of o-xylene ceased after toluene, ethylbenzene, and m-xylene were depleted in the Fort Bragg and sludge microcosms, but o-xylene continued to degrade in microcosms with contaminated Sleeping Bear Dunes soil. The most probable number (MPN) of denitrifiers in these nine different inocula were measured using a microtiter technique. There was no correlation between the MPN of denitrifiers and the TEX degradation rate under denitrifying conditions. Experimental results indicate that the degradation sequence and TEX degradation rate under denitrifying conditions may differ among sites. Results also indicate that denitrification alone may not be a suitable bioremediation technology for gasoline-contaminated aquifers because of the inability of denitrifiers to degrade benzene

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

Science.gov (United States)

2011-09-01

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic... functions. SSCs in operating nuclear power plants are designed either in accordance with, or have been... nuclear reactors. The background information relevant to this GL includes the individual plant...

Practicing the Generic (City)

DEFF Research Database (Denmark)

Hansen, Lone Koefoed

2010-01-01

Flanagan proposes that most locative media artworks neglect the particularities of spaces, their historical and political layers. Koolhaas, on the other hand, states that all urban areas are alike, that we are facing a global Generic City. The paper analyses digital media artist Esther Polak......’s NomadicMILK project in light of the generic and particular properties of space as laid out by Flanagan and Koolhaas in order to discuss the possible reconfiguring practices of locative media....

Generic conditional clearance for very low level active charcoal generated in nuclear power plant operation

International Nuclear Information System (INIS)

Gomez Perales, J. J.; Burgos Gallego, J.; Alvarez Mir, F.; Luis de Diego, J.; Adrada Garcia, J.

1998-01-01

This report proposes a generic conditional exemption to the very low level active charcoal generated in the operation of a NPP. The project has been developed in two parts: a common one (applied to the stream to be exempted) and a specific one (specific to the NPP that fulfills already the common part requirements). The common project specifies the methodology and the disposal options. It provides derived exemption levels and maximum amount of activity the exemption of which be feasible, demonstrating the viability of their conventional management. The specific project of each NPP will develop the amount of waste to be managed and other details that supplement the previous project, adjusting to the methodology and disposal options in the common project. The proposed management suggestion consists in burning the waste in a coal-burning plant and disposing of the scum in a controlled landfill. The resultant radiological dose is considered negligible according to the document Safety Series N 89 of the IAEA. The calculation of the radiological dose associated to several stages has been carried out using the IMPACTS-BRC code, contained in NUREG/CR-3585 and NUREG/5517. The methodology used in the radiological dose evaluation is as recommended in the Safety Guide n. 7.8 of the Spanish Nuclear Safety Council. (Author)

Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

Science.gov (United States)

Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen F; Lii, Joyce; Rogers, James R; Dutcher, Sarah K; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael A; Kesselheim, Aaron S; Gagne, Joshua J

2018-01-01

Abstract Objectives To compare rates of switchbacks to branded drug products for patients switched from branded to authorized generic drug products, which have the same active ingredients, appearance, and excipients as the branded product, with patients switched from branded to generic drug products, which have the same active ingredients as the branded product but may differ in appearance and excipients. Design Observational cohort study. Setting Private (a large commercial health plan) and public (Medicaid) insurance programs in the US. Participants Beneficiaries of a large US commercial health insurer between 2004 and 2013 (primary cohort) and Medicaid beneficiaries between 2000 and 2010 (replication cohort). Main outcome measures Patients taking branded products for one of the study drugs (alendronate tablets, amlodipine tablets, amlodipine-benazepril capsules, calcitonin salmon nasal spray, escitalopram tablets, glipizide extended release tablets, quinapril tablets, and sertraline tablets) were identified when they switched to an authorized generic or a generic drug product after the date of market entry of generic drug products. These patients were followed for switchbacks to the branded drug product in the year after their switch to an authorized generic or a generic drug product. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals after adjusting for demographics, including age, sex, and calendar year. Inverse variance meta-analysis was used to pool adjusted hazard ratios across all drug products. Results A total of 94 909 patients switched from branded to authorized generic drug products and 116 017 patients switched from branded to generic drug products and contributed to the switchback analysis. Unadjusted incidence rates of switchback varied across drug products, ranging from a low of 3.8 per 100 person years (for alendronate tablets) to a high of 17.8 per 100 person years (for amlodipine

Structural analysis of porous rock reservoirs subjected to conditions of compressed air energy storage

Energy Technology Data Exchange (ETDEWEB)

Friley, J.R.

1980-01-01

Investigations are described which were performed to assess the structural behavior of porous rock compressed air energy storage (CAES) reservoirs subjected to loading conditions of temperature and pressure felt to be typical of such an operation. Analyses performed addressed not only the nominal or mean reservoir response but also the cyclic response due to charge/discharge operation. The analyses were carried out by assuming various geometrical and material related parameters of a generic site. The objective of this study was to determine the gross response of a generic porous reservoir. The site geometry for this study assumed a cylindrical model 122 m in dia and 57 m high including thicknesses for the cap, porous, and base rock formations. The central portion of the porous zone was assumed to be at a depth of 518 m and at an initial temperature of 20/sup 0/C. Cyclic loading conditions of compressed air consisted of pressure values in the range of 4.5 to 5.2 MPa and temperature values between 143 and 204/sup 0/C.Various modes of structural behavior were studied. These response modes were analyzed using loading conditions of temperature and pressure (in the porous zone) corresponding to various operational states during the first year of simulated site operation. The results of the structural analyses performed indicate that the most severely stressed region will likely be in the wellbore vicinity and hence highly dependent on the length of and placement technique utilized in the well production length. Analyses to address this specific areas are currently being pursued.

Brand and generic medications: Are they interchangeable

International Nuclear Information System (INIS)

Al-Jazairi, Abdulrazak S.; Blhareth, S.; Eqtefan, Iyad S.; Al-Suwayeh, Saleh A.

2008-01-01

Generic substitution has become a common practice since the late 1970s in the United States. At that time, many of these generics caused bioavailability problems, which fueled suspicions about their efficacy and safety and the Food and Drug Administration (FDA) standards for bioequivalence. In Saudi Arabia, the increasing number of local products raised several concerns with regard to switching from brands to generics. Our objective was to review and examine the basis of the controversy surrounding brand and generic interchangeability and to explore a practical approach in pursuing a switch. Articles indexed initially under terms such as generic medications, generic substitution, bioequivalence and bioinequivalence were identified. These terms were used to search the indexing service, MEDLINE (1966-2006). References from the extracted articles and additional data sources, including the Code of Federal Regulations and Regulatory Guidelines from the FDA Center for Drug Evaluation and research were also reviewed. Foe most drugs, bioequivalence testing generally should enable clinicians to routinely substitute generic for innovator products. However, for narrow therapeutic, critical dose drugs, or for highly variable drugs, safe switching between products can not be assured. These drugs need special precautions and blood level monitoring upon switching. FDA firmly believes that approved generic and brand drugs can be dispensed with the full expectation that the consumer will receive the same clinical benefit. Performing the switch process is an advisable practice to reduce health care costs in countries with strong post-marketing surveillance program, but caution is to be exercised when narrow therapeutic index drugs or highly variable drugs are prescribed. (author)

Contact Geometry of Hyperbolic Equations of Generic Type

Directory of Open Access Journals (Sweden)

Dennis The

2008-08-01

Full Text Available We study the contact geometry of scalar second order hyperbolic equations in the plane of generic type. Following a derivation of parametrized contact-invariants to distinguish Monge-Ampère (class 6-6, Goursat (class 6-7 and generic (class 7-7 hyperbolic equations, we use Cartan's equivalence method to study the generic case. An intriguing feature of this class of equations is that every generic hyperbolic equation admits at most a nine-dimensional contact symmetry algebra. The nine-dimensional bound is sharp: normal forms for the contact-equivalence classes of these maximally symmetric generic hyperbolic equations are derived and explicit symmetry algebras are presented. Moreover, these maximally symmetric equations are Darboux integrable. An enumeration of several submaximally symmetric (eight and seven-dimensional generic hyperbolic structures is also given.

Generic Accounting and Reporting Software for Research Reactors

International Nuclear Information System (INIS)

Jaernry, C.

2010-01-01

This poster will give a general description of a generic accounting and reporting software for research reactors. The program has been designed to be a powerful working tool for the operator. The software is designed to be extremely easy to handle and at the same time give the operator the maximal power of searches, calculations and reports that a modern advanced system can produce. The systems are designed to take make the relevant accountancy for the site and perform the reporting to IAEA in Code 10. Generic software for accounting and reporting for research and other smaller facilities is something that has been asked for by many parties. Software like this could be distributed to facilities in need of a powerful accountancy and reporting system for a much lower cost than the systems that is now custom made for these facilities. This will greatly increase the quality of accountancy at these facilities and the quality of the reporting to IAEA and other state offices etc. The software is based on our advanced custom made software series 'STAR' that has been in use in many places for more than a decade with successful use. (author)

Generic evolution of mixing in heterogeneous media

Science.gov (United States)

De Dreuzy, J.; Carrera, J.; Dentz, M.; Le Borgne, T.

2011-12-01

Mixing in heterogeneous media results from the competition bewteen flow fluctuations and local scale diffusion. Flow fluctuations quickly create concentration contrasts and thus heterogeneity of the concentration field, which is slowly homogenized by local scale diffusion. Mixing first deviates from Gaussian mixing, which represents the potential mixing induced by spreading before approaching it. This deviation fundamentally expresses the evolution of the interaction between spreading and local scale diffusion. We characterize it by the ratio γ of the non-Gaussian to the Gaussian mixing states. We define the Gaussian mixing state as the integrated squared concentration of the Gaussian plume that has the same longitudinal dispersion as the real plume. The non-Gaussian mixing state is the difference between the overall mixing state defined as the integrated squared concentration and the Gaussian mixing state. The main advantage of this definition is to use the full knowledge previously acquired on dispersion for characterizing mixing even when the solute concentration field is highly non Gaussian. Using high precision numerical simulations, we show that γ quickly increases, peaks and slowly decreases. γ can be derived from two scales characterizing spreading and local mixing, at least for large flux-weighted solute injection conditions into classically log-normal Gaussian correlated permeability fields. The spreading scale is directly related to the longitudinal dispersion. The local mixing scale is the largest scale over which solute concentrations can be considered locally uniform. More generally, beyond the characteristics of its maximum, γ turns out to have a highly generic scaling form. Its fast increase and slow decrease depend neither on the heterogeneity level, nor on the ratio of diffusion to advection, nor on the injection conditions. They might even not depend on the particularities of the flow fields as the same generic features also prevail for

Generic penetration in the retail atypical antipsychotic market.

Science.gov (United States)

Lenderts, Susan; Kalali, Amir H; Buckley, Peter

2010-03-01

In this article, we explore the penetration of generic atypical antipsychotics in the United States market before and after the availability of generic risperidone in July 2008. Analysis suggests that, overall, generic penetration into the atypical antipsychotic market has grown from approximately three percent in January 2008 to more than 25 percent in December 2009. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

Geotechnical conditions of Bulgaria and site selection for radioactive waste repository

International Nuclear Information System (INIS)

Iliev, I.; Tacheva, E.

1993-01-01

A comparative study of the complex structure of the Bulgarian lands and the engineering geological criteria for site selection of national repositories for high level radwastes is made. A detailed description of the following geotechnical conditions of Bulgaria's territory is given: genetic, lithological and engineering-geological types of rocks; physico-mechanical parameters of the most widespread rocky and semi-rocky engineering geological types; fissuring of the rocks; rock massifs; geodynamic processes. The number of promising variants for repositories have been classified according to the structure of the rock massif and the engineering-geological properties of the layers which are promising for the purpose. The following sites are investigated: 1) sites in one-type homogeneous rock massifs of high strength and elasticity; 2) sites of various type massifs with a promising layer of rocks with medium strength and elasticity; 3) sites in various type massifs with a promising layer of plastic rocks of low strength. It is concluded that the complexity of the geotechnical and other conditions in the territory of Bulgaria would predetermine the deficiency of the list of the properties required for the selected sites. The building up of engineering defence will be needed to offset that deficiency and their problems will be resolved after the specific site have been chosen. Geotechnical elements should be likewise envisaged within the general pattern of the monitoring needed. The designing, installing and putting into operation of the monitoring systems should be accomplished as early as the stage of the detailed investigation of the site selected. 19 refs., 2 suppls. (author)

Impact of Site Elevation on Mg Smelter Design

Science.gov (United States)

Baker, Phillip W.

Site elevation has many surprising and significant impacts on the engineering design of metallurgical plant of all types. Electrolytic magnesium smelters maybe built at high elevation for a variety of reasons including availability of raw material, energy or electric power. Because of the unit processes they typically involve, Mg smelters can be extensively impacted by site elevation. In this paper, generic examples of the design changes required to adapt a smelter originally designed for sea level to operate at 2700 m are presented. While the examples are drawn from a magnesium plant design case, these changes are generically applicable to all industrial plants utilizing similar unit processes irrespective of product.

EPRI spearheads generic PM recommendations for infrastructure equipment

International Nuclear Information System (INIS)

Worledge, David H.; Hinchcliffe, Glenn R.; Benak, Mark S.; Bridges, Martin

2007-01-01

All companies have at their core a vast amount of similar equipment that would benefit from solid preventive maintenance (PM) recommendations that are generic and easily adapted to meet operational conditions. The re-emergence of PM optimization methods like Reliability Centered Maintenance, further illustrates that companies in all industries recognize the positive influence that a well-focused maintenance program has on the corporate bottom line. The Electric Power Research Institute (EPRI) has long been a leader in providing universally adaptable maintenance solutions to meet the evolving needs of its membership. Nearly ten years ago, EPRI began developing the PM Basis Database, a one-of-a-kind repository of PM recommendations for basic infrastructure components (such as pumps, motors, valves, compressors), derived from equipment experts. EPRI has now made available this comprehensive body of knowledge to all industries. This paper will explore the origins and structure of the database, how these generic PM recommendations benefit every industry, and how they may be obtained. (author)

Controlling the site density of multiwall carbon nanotubes via growth conditions

Science.gov (United States)

Siegal, M. P.; Overmyer, D. L.; Kaatz, F. H.

2004-06-01

We present two complementary methods for controlling the site density of multiwall carbon nanotubes (CNTs) directly as a function of growth conditions from 1011to107CNTs/cm2. Several potential applications require significant spacing between individual CNTs. The first method shows that the site density varies with the heat of formation of the hydrocarbon gas used during CNT growth by thermal chemical vapor deposition. The second method demonstrates that the site density decreases with increasing residual stress of the metal catalyst/diffusion barrier layers. These methods are combined for wide-range control of CNT site density.

40 CFR 721.2083 - Polysubstituted carbomonocyclic hydroxylamine (generic).

Science.gov (United States)

2010-07-01

... hydroxylamine (generic). 721.2083 Section 721.2083 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.2083 Polysubstituted carbomonocyclic hydroxylamine (generic). (a... generically as a polysubstituted carbomonocyclic hydroxylamine (PMN P-97-878) is subject to reporting under...

Sharing, samples, and generics: an antitrust framework.

Science.gov (United States)

Carrier, Michael A

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

[Consensus clinical practice guidelines of the Andalusian Epilepsy Society on prescribing generic antiepileptic drugs].

Science.gov (United States)

Cañadillas-Hidalgo, F M; Sánchez-Alvarez, J C; Serrano-Castro, P J; Mercadé-Cerdá, J M

Pharmaceutical spending in Spain accounts for 1.2-1.4% of the gross domestic product and is increasing by 5-12% per year. One of the measures adopted by the government to cut this spending is the possible substitution of original prescribed drugs by generics. In the case of antiepileptic drugs (AED), which are characterised by a scant therapeutic margin, these steps have sparked a scientific debate about their repercussion on the control of epileptic patients. We propose to draw up a set of implicit evidence-based consensus practice guidelines concerning issues related with this topic. A selective search for quality scientific information on the subject was conducted on PubMed-Medline, Tripdatabase and the Biblioteca Cochrane Plus. The selected references were analysed and discussed by the authors, and the recommendations deriving from them were collected. A total of 21 primary documents and 16 practice guidelines, protocols or experts' recommendations were identified. Our recommendations were explicitly included at the end of the text. The Andalusian Epilepsy Society makes the following recommendations: 1) not replacing an innovative AED by its generic in a controlled patient; 2) beginning treatment with a generic AED in monotherapy or in association is acceptable; 3) not exchanging generic AED from different pharmaceutical companies; 4) explaining to the patient the rules governing the authorization of generics and the importance of avoiding exchanges between different generic AED; and 5) if there is some worsening of the clinical condition or side effects appear following the introduction of a generic, the causes must be investigated and communicated to the bodies responsible for pharmacovigilance.

Associations between generic substitution and patients' attitudes, beliefs and experience

DEFF Research Database (Denmark)

Østergaard Rathe, Jette; Larsen, Pia Veldt; Andersen, Morten

2013-01-01

Abstract Background Generic substitution has been implemented in many countries, but knowledge about patients’ attitudes, beliefs and experiences is still sparse. Aim To assess associations between generic switching and patients’ attitudes, beliefs and experiences with previous generic switching...... on generic medicine and confidence in the healthcare system. Only prescriptions issued by the general practitioners were included. For each patient we focused on one purchase of a generically substitutable drug (index drug). Patients were identified by means of a dispensing database. Results Earlier generic...... switches within the index ATC code were statistically significantly associated with experience of a generic switch (adjusted OR 5.93 95% CI 4.70; 7.49). Having had more than 5 earlier switches within other ATC codes and having negative views on generic medicines reduced the odds of experiencing a generic...

Generics, Supergenerics and Patent Strategies--SMi's 13th Annual Meeting.

Science.gov (United States)

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.

PROBLEM OF GENERIC REPLACEMENT: ADVANTAGES AND DISADVANTAGES

Directory of Open Access Journals (Sweden)

S. N. Tolpygina

2009-01-01

Full Text Available The main differences between original and generic drugs as well as registration criteria for generics are described. Possible reasons of discrepancy in bioequivalence and therapeutic equivalence of original and generic drugs are reviewed. The examples of such a discrepancy as a result of comparative clinical trails (enalapril maleate are discussed. Approaches to planning of comparative trails on drug therapeutic equivalence are presented. 

A generic coordinate system and a set of generic variables for MFE database

International Nuclear Information System (INIS)

Miner, W.H. Jr.; Ross, D.W.; Solano, E.R.; Valanju, P.M.; Wiley, J.C.

1993-01-01

Over the last several years, profile data from nine different tokamaks have been stored in the magnetic fusion energy database (MFEDB). These data sets have come from a variety of sources and most are given in different coordinate systems. In order to attempt any intermachine analysis, it is convenient to transform these data sets into one generic coordinate system and to choose a uniform set of variable names. The authors describe the data sets from each tokamak indicating the source of the data and the coordinate system in which it is given. Next, they discuss the generic coordinate that has been adopted and show how it is implemented for each tokamak. Finally, the generic naming convention that has been adopted is discussed. It follows closely that which was used by Christiansen et al. for the ITER Global Energy Confinement H-Mode Database. For further clarification, they discuss the characteristics of the magnetic geometry given a Fourier representation of the magnetic equilibria

The quantum oscillator on complex projective space (Lobachewski space) in a constant magnetic field and the issue of generic boundary conditions

International Nuclear Information System (INIS)

Giri, Pulak Ranjan

2007-01-01

We perform a one-parameter family of self-adjoint extensions characterized by the parameter ω 0 . This allows us to get generic boundary conditions for the quantum oscillator on N-dimensional complex projective space (CP N ) and on its non-compact version, i.e., Lobachewski space (L N ) in the presence of a constant magnetic field. As a result, we get a family of energy spectra for the oscillator. In our formulation the already known result of this oscillator also belongs to the family. We have also obtained an energy spectrum which preserves all the symmetries (full-hidden symmetry and rotational symmetry) of the oscillator. The method of self-adjoint extensions has also been discussed for a conic oscillator in the presence of the constant magnetic field

Ongoing change of site conditions important for sustainable forest management planning

Science.gov (United States)

Bidló, András; Horváth, Adrienn; Gulyás, Krisztina; Gálos, Borbála

2016-04-01

Observed tree mortality of the last decades has shown that the vulnerable forest ecosystems are especially affected by the recurrent, long lasting droughts, heat waves and their consequences. From all site conditions climate is changing the fastest, in this way it can be the largest threatening factor in the 21st century. Beyond climate, soil characteristics are playing an important influencing role. Until now, silvicultural technologies and species preferences of many countries are prescribed by binding regulation based on climate conditions that are assumed to be constant over time. Therefore the aim of our research was to investigate the ongoing and projected change of site conditions that are considered to be of primary importance in terms of tree species selection. For a case study region in Hungary (Keszthely Mountains, near to Lake Balaton) long-term climate tendencies have been determined for the period 1961-2100, as well as a detailed soil sample analysis has been carried out including ~100 sites. Results show a 0.5 degree increase of temperature and a 6-7 % decrease of the precipitation amount for the summer months in the last decades. For the future, significant warming and drying of summers is expected. Decrease of the summer precipitation sum can exceed 25 % until the end of the century, probability of extreme hot days may increase. These tendencies together with the unfavourable soil conditions and biotic damages can be the reason of the ongoing forest dieback. One of the characteristic soil type of the region is rendzina with a thin topsoil layer and an unfavourable water holding capacity. These properties are limiting the amount of available water for plants, especially in case of intense precipitation events. Black pine stands planted on rendzinas after many years of grazing; therefore erosion may have played a significant role. Not only microclimate conditions but also soil types show a large diversity within a relatively small distance. However

Generic Software Architecture for Launchers

Science.gov (United States)

Carre, Emilien; Gast, Philippe; Hiron, Emmanuel; Leblanc, Alain; Lesens, David; Mescam, Emmanuelle; Moro, Pierre

2015-09-01

The definition and reuse of generic software architecture for launchers is not so usual for several reasons: the number of European launcher families is very small (Ariane 5 and Vega for these last decades); the real time constraints (reactivity and determinism needs) are very hard; low levels of versatility are required (implying often an ad hoc development of the launcher mission). In comparison, satellites are often built on a generic platform made up of reusable hardware building blocks (processors, star-trackers, gyroscopes, etc.) and reusable software building blocks (middleware, TM/TC, On Board Control Procedure, etc.). If some of these reasons are still valid (e.g. the limited number of development), the increase of the available CPU power makes today an approach based on a generic time triggered middleware (ensuring the full determinism of the system) and a centralised mission and vehicle management (offering more flexibility in the design and facilitating the long term maintenance) achievable. This paper presents an example of generic software architecture which could be envisaged for future launchers, based on the previously described principles and supported by model driven engineering and automatic code generation.

Impact of Spacing of Practice on Learning Brand Name and Generic Drugs.

Science.gov (United States)

Terenyi, James; Anksorus, Heidi; Persky, Adam M

2018-02-01

Objective. To test the impact of schedules of retrieval practice on learning brand and generic name drug information in a self-paced course. Methods. Students completed weekly quizzes on brand and generic name conversions for 100 commonly prescribed drugs. Each student completed part of the drug list on a schedule of equal, expanding, or contracting spacing, one practice (massed) or study only in a partial block design. Results. On measures of long-term retention, the contracting spacing schedule led to superior retention (67%) compared to the massed practice (50%) and study-only condition (46%); contracting practice also was significantly higher than expanding practice (58%,) or equal practice (59%). Overall performance decreased by almost 50% (final exam 95%, long-term retention 55%) over a 6-week period. Conclusion. A contracting spacing schedule was the most effective schedule of practice, and all spacing schedules were superior to massed practice or study-only conditions.

40 CFR 721.324 - Alkoxylated acrylate polymer (generic).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkoxylated acrylate polymer (generic... Substances § 721.324 Alkoxylated acrylate polymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkoxylated acrylate polymer...

Generic maintenance immunosuppression in solid organ transplant recipients.

Science.gov (United States)

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.

Hydrogeochemical conditions at the Haestholmen site

International Nuclear Information System (INIS)

Luukkonen, A.; Pitkaenen, P.; Ruotsalainen, P.; Leino-Forsman, H.; Snellman, M.

1999-06-01

The characterisation and interpretation of groundwater geochemistry has been ongoing at several study sites for spent fuel disposal in Finland since the late 1980s. The former evaluation of the Haestholmen groundwater from depths to 240 m was performed between 1980 and 1992 during the investigations for the construction of the reactor waste repository. Haestholmen was included in the site characterisation programme for spent fuel disposal in 1997. The sampling of groundwater down to 1000 m was started in 1997 from deep boreholes and this study presents the evaluation of the hydro-geochemistry at Haestholmen extending below 200m. The dilute HCO 3 -rich groundwater seems to be limited to the upper 60 m and it is probably controlled by subhorizontal zone R1. According to the tritium data, the dilute groundwater is recently infiltrated, less than 45 years ago. Brackish SO 4 -rich groundwater has been obtained from a depth of about 60 m to a depth of about 600 m. The data show a strong input of the Litorina sea water mixed in the groundwater system as well as input of glacial melt water in the brackish ground-water layer. The infiltration of Litorina sea water is based on marine Br/Cl ratios, δO-18/δH-2, and δS-34 data. The C-14 datings, together with a higher salinity than the present Baltic indicate a Litorina Sea water origin. Melt water is interpreted according to decreasing δH-2 and δO-18 with salinity and depth in the brackish water layer. The saline groundwater is obtained from below 600 m. Stable isotope (δO-18 and δH-2) results, high Ca/Cl, Ca/Mg and Br/Cl ratios suggest a hydrothermal saline end-member. However, the marine signature is also observable in saline water, which is interpreted to originate from the Pre-Weichselian Sea, possibly from the Eem Sea. In accordance with another study site, Olkiluoto, the hydrochemistry of Haestholmen seems to contain a layered sequence of climatic and shoreline changes from modern times through former Baltic

Hydrogeochemical conditions at the Haestholmen site

Energy Technology Data Exchange (ETDEWEB)

Luukkonen, A.; Pitkaenen, P. [VTT Communities and Infrastructure, Espoo (Finland); Ruotsalainen, P. [Fintact Oy (Finland); Leino-Forsman, H. [VTT Chemical Technology, Espoo (Finland); Snellman, M. [Posiva Oy, Helsinki (Finland)

1999-06-01

The characterisation and interpretation of groundwater geochemistry has been ongoing at several study sites for spent fuel disposal in Finland since the late 1980s. The former evaluation of the Haestholmen groundwater from depths to 240 m was performed between 1980 and 1992 during the investigations for the construction of the reactor waste repository. Haestholmen was included in the site characterisation programme for spent fuel disposal in 1997. The sampling of groundwater down to 1000 m was started in 1997 from deep boreholes and this study presents the evaluation of the hydro-geochemistry at Haestholmen extending below 200m. The dilute HCO{sub 3}-rich groundwater seems to be limited to the upper 60 m and it is probably controlled by subhorizontal zone R1. According to the tritium data, the dilute groundwater is recently infiltrated, less than 45 years ago. Brackish SO{sub 4}-rich groundwater has been obtained from a depth of about 60 m to a depth of about 600 m. The data show a strong input of the Litorina sea water mixed in the groundwater system as well as input of glacial melt water in the brackish ground-water layer. The infiltration of Litorina sea water is based on marine Br/Cl ratios, {delta}O-18/{delta}H-2, and {delta}S-34 data. The C-14 datings, together with a higher salinity than the present Baltic indicate a Litorina Sea water origin. Melt water is interpreted according to decreasing {delta}H-2 and {delta}O-18 with salinity and depth in the brackish water layer. The saline groundwater is obtained from below 600 m. Stable isotope ({delta}O-18 and {delta}H-2) results, high Ca/Cl, Ca/Mg and Br/Cl ratios suggest a hydrothermal saline end-member. However, the marine signature is also observable in saline water, which is interpreted to originate from the Pre-Weichselian Sea, possibly from the Eem Sea. In accordance with another study site, Olkiluoto, the hydrochemistry of Haestholmen seems to contain a layered sequence of climatic and shoreline changes

Skin rash during treatment with generic itraconazole

OpenAIRE

De Vuono, Antonio; Palleria, Caterina; Scicchitano, Francesca; Squillace, Aida; De Sarro, Giovambattista; Gallelli, Luca

2014-01-01

Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re...

Generic medicine and prescribing: A quick assessment

Directory of Open Access Journals (Sweden)

Mainul Haque

2017-01-01

Full Text Available Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts. The Food and Drug Administration (FDA describes that generic drugs are essential possibilities that allow better access to healthcare for all Americans. They are replicas of brand-name drugs and are the identical as those of brand-name drugs in dosage form, safety, strength, route of administration, quality, performance features, and anticipated to use. Healthcare authorities and users can be guaranteed that FDA-approved generic drug products have met the same stiff principles as the innovator drug. The company that made Bayer aspirin fought in court enthusiastically to keep generic versions off the shelves, in the 1920s. The company lost in court, and consumers suddenly had an array of choices in generic aspirin. The Supreme Court of India uttering ‘the Supreme Court's ruling will prevent companies from further seeking unwarranted patents on HIV and other essential medicines.’ Generic medicine cannot be sold at a price higher than the branded medicine, so it is regularly a low-priced option. Thereafter, both the end user and the government who pay for part of the price of the medicine under the Pharmaceutical Benefits Scheme in Australia are benefitted. The treatment of diseases using essential drugs, prescribed by their generic names, has been emphasised by the WHO and many national health policies. Although there are some improvements in generic medicine prescribing, it has been advised by the WHO that ‘countries should intensify efforts to measure and regularly monitor medicine prices and availability, and adopt policy measures to address the issues identified.’

Environmental conditions of two abandoned uranium mill tailings sites in northern Saskatchewan

International Nuclear Information System (INIS)

Kalin, M.

Two abandoned uranium mill tailings sites near Uranium City, Saskatchewan, have been studied in an attempt to follow the natural rehabilitation processes. The Gunnar site is a largely terrestrial environment while the Lorado mill tailings were discharged mainly into Nero Lake. This report describes the ecological conditions of both sites, potential long-term environmental degradation, and possible measures to assist the recovery of both areas

40 CFR 721.5350 - Substituted nitrile (generic name).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Substituted nitrile (generic name... Substances § 721.5350 Substituted nitrile (generic name). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as a substituted nitrile (PMN P-83...

Early Site Permit Demonstration Program: Plant parameters envelope report

International Nuclear Information System (INIS)

1993-03-01

The Early Site Permit (ESP) Demonstration Program is the nuclear industry's initiative for piloting the early resolution of siting-related issues before the detailed design proceedings of the combined operating license review. The ESP Demonstration Program consists of three phases. The plant parameters envelopes task is part of Phase 1, which addresses the generic review of applicable federal regulations and develops criteria for safety and environmental assessment of potential sites. The plant parameters envelopes identify parameters that characterize the interface between an ALWR design and a potential site, and quantify the interface through values selected from the Utility Requirements Documents, vendor design information, or engineering assessments. When augmented with site-specific information, the plant parameters envelopes provide sufficient information to allow ESPs to be granted based on individual ALWR design information or enveloping design information for the evolutionary, passive, or generic ALWR plants. This document is expected to become a living document when used by future applicants

Generic Penetration of the SSRI Market.

Science.gov (United States)

Cascade, Elisa F; Kalali, Amir H

2008-04-01

In this article, we investigate the penetration of generic selective serotonin reuptake inhibitors (SSRIs) in the US market and the implications for patient out-of-pocket expense. The data suggest that generic penetration into the SSRI market has grown from approximately nine percent in 2000, the year that the patent for Prozac((R)) expired, to 72 percent in 2007. For December, 2007, the difference in patient out-of-pocket expense for branded vs. generic agents was, on average, $55.42 for patients paying by cash (i.e., they had no prescription drug insurance) and $22.39 for patients with insurance coverage.

Hydrologic site characterization - the UMTRA project approach

International Nuclear Information System (INIS)

Binkman, J.E.; Hoopes, J.R.

1985-01-01

The United States Environmental Protection Agency (EPA) Standards (40 CFR 192) require site characterization of the hydrogeologic regime at and around each Uranium Mill Tailings Remedial Action (UMTRA) Project site. Also, ''judgements on the possible need for remedial or protective actions for groundwater aquifers should be guided by relevant considerations described in EPA's hazardous waste management system (47 CFR 32274).'' To address those two sets of rules and regulations, a generic approach is being developed. Fourteen primary issues were determined. These issues can be grouped into those that can be determined by documentation of available information and present conditions, those that require extensive field investigations and those that require some form of predictive modeling. To address the various issues requires an integrated effort of hydrogeologists, environmental engineers or scientists and health physicists. In this paper, the approach to the resolution of these fourteen issues is described briefly

ITER plant layout and site services

International Nuclear Information System (INIS)

Chuyanov, V.A.

2000-01-01

The ITER site has not yet been determined. Nevertheless, to develop a construction plan and a cost estimate, it is necessary to have a detailed layout of the buildings, structures and outdoor equipment integrated with the balance of plant service systems prototypical of large fusion power plants. These services include electrical power for magnet feeds and plasma heating systems, cryogenic and conventional cooling systems, compressed air, gas supplies, demineralized water, steam and drainage. Nuclear grade facilities are provided to handle tritium fuel and activated waste, as well as to prevent radiation exposure of workers and the public. To prevent interference between services of different types and for efficient arrangement of buildings, structures and equipment within the site area, a plan was developed which segregated different classes of services to four quadrants surrounding the tokamak building, placed at the approximate geographical centre of the site. The locations of the buildings on the generic site were selected to meet all design requirements at minimum total project cost. A similar approach was used to determine the locations of services above, at and below grade. The generic site plan can be adapted to the site selected for ITER without significant changes to the buildings or equipment. Some rearrangements may be required by site topography, resulting primarily in changes to the length of services that link the buildings and equipment. (author)

40 CFR 721.555 - Alkyl amino nitriles (generic).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkyl amino nitriles (generic). 721... Substances § 721.555 Alkyl amino nitriles (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as alkyl amino nitriles (PMNs P-96...

A Generic Approach to Parameter Control

NARCIS (Netherlands)

Karafotias, G.; Smit, S.K.; Eiben, A.E.

2012-01-01

On-line control of EA parameters is an approach to parameter setting that offers the advantage of values changing during the run. In this paper, we investigate parameter control from a generic and parameter-independent perspective. We propose a generic control mechanism that is targeted to

Investigation of an alternative generic model for predicting pharmacokinetic changes during physiological stress.

Science.gov (United States)

Peng, Henry T; Edginton, Andrea N; Cheung, Bob

2013-10-01

Physiologically based pharmacokinetic models were developed using MATLAB Simulink® and PK-Sim®. We compared the capability and usefulness of these two models by simulating pharmacokinetic changes of midazolam under exercise and heat stress to verify the usefulness of MATLAB Simulink® as a generic PBPK modeling software. Although both models show good agreement with experimental data obtained under resting condition, their predictions of pharmacokinetics changes are less accurate in the stressful conditions. However, MATLAB Simulink® may be more flexible to include physiologically based processes such as oral absorption and simulate various stress parameters such as stress intensity, duration and timing of drug administration to improve model performance. Further work will be conducted to modify algorithms in our generic model developed using MATLAB Simulink® and to investigate pharmacokinetics under other physiological stress such as trauma. © The Author(s) 2013.

Developing competitive and sustainable Polish generic medicines market.

Science.gov (United States)

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.

The Generic Data Capture Facility

Science.gov (United States)

Connell, Edward B.; Barnes, William P.; Stallings, William H.

1987-01-01

The Generic Data Capture Facility, which can provide data capture support for a variety of different types of spacecraft while enabling operations costs to be carefully controlled, is discussed. The data capture functions, data protection, isolation of users from data acquisition problems, data reconstruction, and quality and accounting are addressed. The TDM and packet data formats utilized by the system are described, and the development of generic facilities is considered.

Pharmaceutical quality of seven generic Levodopa/Benserazide products compared with original Madopar® / Prolopa®.

Science.gov (United States)

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

Does educational intervention improve doctors’ knowledge and perceptions of generic medicines and their generic prescribing rate? A study from Malaysia

Science.gov (United States)

Wong, Zhi Yen; Alrasheedy, Alian A.; Saleem, Fahad; Mohamad Yahaya, Abdul Haniff; Aljadhey, Hisham

2014-01-01

Objectives: To investigate the impact of an educational intervention on doctors’ knowledge and perceptions towards generic medicines and their generic (international non-proprietary name) prescribing practice. Methods: This is a single-cohort pre-/post-intervention pilot study. The study was conducted in a tertiary care hospital in Perak, Malaysia. All doctors from the internal medicine department were invited to participate in the educational intervention. The intervention consisted of an interactive lecture, an educational booklet and a drug list. Doctors’ knowledge and perceptions were assessed by using a validated questionnaire, while the international non-proprietary name prescribing practice was assessed by screening the prescription before and after the intervention. Results: The intervention was effective in improving doctors’ knowledge towards bioequivalence, similarity of generic medicines and safety standards required for generic medicine registration (p = 0.034, p = 0.034 and p = 0.022, respectively). In terms of perceptions towards generic medicines, no significant changes were noted (p > 0.05). Similarly, no impact on international non-proprietary name prescribing practice was observed after the intervention (p > 0.05). Conclusion: Doctors had inadequate knowledge and misconceptions about generic medicines before the intervention. Moreover, international non-proprietary name prescribing was not a common practice. However, the educational intervention was only effective in improving doctors’ knowledge of generic medicines. PMID:26770747

A developmental analysis of generic nouns in Southern Peruvian Quechua.

Science.gov (United States)

Mannheim, Bruce; Gelman, Susan A; Escalante, Carmen; Huayhua, Margarita; Puma, Rosalía

2010-01-01

Generic noun phrases (e.g., "Cats like to drink milk") are a primary means by which adults express generalizations to children, yet they pose a challenging induction puzzle for learners. Although prior research has established that English speakers understand and produce generic noun phrases by preschool age, little is known regarding the cross-cultural generality of generic acquisition. Southern Peruvian Quechua provides a valuable comparison because, unlike English, it is a highly inflected language in which generics are marked by the absence rather than the presence of any linguistic markers. Moreover, Quechua is spoken in a cultural context that differs markedly from the highly educated, middle-class contexts within which earlier research on generics was conducted. We presented participants from 5 age groups (3-6, 7-9, 10-12, 14-35, and 36-90 years of age) with two tasks that examined the ability to distinguish generic from non-generic utterances. In Study 1, even the youngest children understood generics as applying broadly to a category (like "all") and distinct from indefinite reference ("some"). However, there was a developmental lag before children understood that generics, unlike "all", can include exceptions. Study 2 revealed that generic interpretations are more frequent for utterances that (a) lack specifying markers and (b) are animate. Altogether, generic interpretations are found among the youngest participants, and may be a default mode of quantification. These data demonstrate the cross-cultural importance of generic information in linguistic expression.

Value impact analysis of Generic Issue 143, Availability of Heating, Ventilation, Air Conditioning (HVAC) and Chilled Water Systems

Energy Technology Data Exchange (ETDEWEB)

Daling, P.M.; Marler, J.E.; Vo, T.V.; Phan, H.; Friley, J.R. [Pacific Northwest Lab., Richland, WA (United States)

1993-11-01

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 plant 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.

Value impact analysis of Generic Issue 143, Availability of Heating, Ventilation, Air Conditioning (HVAC) and Chilled Water Systems

International Nuclear Information System (INIS)

Daling, P.M.; Marler, J.E.; Vo, T.V.; Phan, H.; Friley, J.R.

1993-11-01

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 plant 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 (∼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

Associations between generic substitution and patient-related factors

DEFF Research Database (Denmark)

Østergaard Rathe, Jette

Associations between generic substitution and patient-related factors Jette Østergaard Rathe1, Pia V. Larsen1, Morten Andersen2, Janus L. Thomsen3, Maja S. Paulsen1, Jens Søndergaard1 1. Research Unit of General Practice, Institute of Public Health, University of Southern Denmark 2. Centre...... for Pharmacoepidemiology, Karolinska Institutet, Department of Medicine Solna, Stockholm, Sweden 3. Danish Quality Unit of General Practice, Odense, Denmark Background Generic substitution means that chemically equivalent but less expensive drugs are dispensed in place of a brand name product. Although generic medicines...... by definition are bioequivalent to their brand name counterparts there are concerns about whether generic substitution is always accompanied by clinical equivalence in terms of effectiveness and that it may cause concerns and thereby causing some skepticism towards generic substitution. There is, however...

Three-dimensional particle image velocimetry in a generic can-type gas turbine combustor

CSIR Research Space (South Africa)

Meyers, BC

2009-09-01

Full Text Available The three-dimensional flow field inside a generic can-type, forward flow, experimental combustor was measured. A stereoscopic Particle Image Velocimetry (PIV) system was used to obtain the flow field of the combustor in the non-reacting condition...

Consumer choice between common generic and brand medicines in a country with a small generic market.

Science.gov (United States)

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

Family Genericity

DEFF Research Database (Denmark)

Ernst, Erik

2006-01-01

Type abstraction in object-oriented languages embody two techniques, each with its own strenghts and weaknesses. The first technique is extension, yielding abstraction mechanisms with good support for gradual specification. The prime example is inheritance. The second technique is functional abst...... the result as family genericity. The presented language design has been implemented....

Hanford Generic Interim Safety Basis

International Nuclear Information System (INIS)

Lavender, J.C.

1994-01-01

The purpose of this document is to identify WHC programs and requirements that are an integral part of the authorization basis for nuclear facilities that are generic to all WHC-managed facilities. The purpose of these programs is to implement the DOE Orders, as WHC becomes contractually obligated to implement them. The Hanford Generic ISB focuses on the institutional controls and safety requirements identified in DOE Order 5480.23, Nuclear Safety Analysis Reports

Hanford Generic Interim Safety Basis

Energy Technology Data Exchange (ETDEWEB)

Lavender, J.C.

1994-09-09

The purpose of this document is to identify WHC programs and requirements that are an integral part of the authorization basis for nuclear facilities that are generic to all WHC-managed facilities. The purpose of these programs is to implement the DOE Orders, as WHC becomes contractually obligated to implement them. The Hanford Generic ISB focuses on the institutional controls and safety requirements identified in DOE Order 5480.23, Nuclear Safety Analysis Reports.

Advances on generic exemption levels and generic clearance levels in the argentinean regulatory field

International Nuclear Information System (INIS)

Muñiz, C.C.; Bossio, M.C.

2011-01-01

With the aim of optimizing the regulatory effort in Argentina, the Nuclear Regulatory Authority (ARN) evaluated two worldwide concepts used in the radioactive waste management field: “Generic Exemption Levels” and “Generic Clearance Levels”. The objective of this paper is to present the progress made in the past two years in relation to these topics and to present the results of the specific requests received from users of radioactive material. Since the approval of both Generic Levels, the ARN received two exemption requests. The first one, regarding the practice of dismantling lighting rods with 241 Am. The other case regards the international trade, distribution, usage and final disposal of lighting products with radioactive material ( 85 Kr and 232 Th). Concerning clearance, there has not been any request yet. However, in the future the ARN expects to receive this kind of requests from nuclear power plants and other facilities related to the nuclear fuel cycle. (authors) [es

Generic medications for you, but brand-name medications for me.

Science.gov (United States)

Keenum, Amy J; Devoe, Jennifer E; Chisolm, Deena J; Wallace, Lorraine S

2012-01-01

Because generic medications are less expensive than brand-name medications, government and private insurers have encouraged and/or mandated the use of generics. This study aimed at evaluating perceptions about generic medications among English-speaking women of childbearing age currently enrolled in U.S. TennCare (Medicaid). We recruited a convenience sample of patients from the waiting room of a primary care/gynecology health clinic, with 80% recruitment rate among those approached. We orally administered a 25-item questionnaire to gather sociodemographic information and to assess beliefs regarding the efficacy, safety, cost, and preferences for personal use of generic medications. The average age of the women (n=172) was 28.8 ± 6.4 years, and most were white (82.0%) and currently married (58.1%). Nearly one-fifth (19.2%) had not completed high school. Most women believed that generic medications were less expensive (97.6%) and better value (60.5%) than brand-name medications, but only 45.3% preferred to take generics themselves. About a quarter (23.3%) believed that brand-name medications were more effective than generics, whereas 13.4% believed that generics caused more side effects. Few women reported that their doctor (29.7%) and/or pharmacist (35.5%) had ever talked to them about taking generics. Awareness of the benefits of generics did not equal preferences for personal use of generics among this sample of women enrolled in U.S. TennCare. Furthermore, women reported that providers-both physicians and pharmacists-infrequently discussed generic substitution with them. Copyright © 2012 Elsevier Inc. All rights reserved.

Towards Using a Generic Robot as Training Partner

DEFF Research Database (Denmark)

Sørensen, Anders Stengaard; Savarimuthu, Thiusius Rajeeth; Nielsen, Jacob

2014-01-01

In this paper, we demonstrate how a generic industrial robot can be used as a training partner, for upper limb training. The motion path and human/robot interaction of a non-generic upper-arm training robot is transferred to a generic industrial robot arm, and we demonstrate that the robot arm can...... implement the same type of interaction, but can expand the training regime to include both upper arm and shoulder training. We compare the generic robot to two affordable but custom-built training robots, and outline interesting directions for future work based on these training robots....

Assessment of Wind Turbine for Site-Specific Conditions using Probabilistic Methods

DEFF Research Database (Denmark)

Heras, Enrique Gómez de las; Gutiérrez, Roberto; Azagra, Elena

2013-01-01

turbines, helping to the decision making during the site assessment phase of wind farm designs. First, the design equation for the failure mode of interest is defined, where the loads associated to the site-specific wind conditions are compared with the design limits of the structural component. A limit...... be very dependent on the site. The uncertainties on the wind properties depend on issues like the available wind data, the quality of the measurement sensors, the type of terrain or the accuracy of the engineering models for horizontal and vertical spatial extrapolation. An example is included showing two...

Site investigations. Investigation methods and general execution programme

International Nuclear Information System (INIS)

2001-01-01

SKB plans to commence site investigations in 2002. The present report is a broadening of the general programme and describes the execution of the investigations in so-called discipline-specific programmes for the disciplines geology, rock mechanics, thermal properties, hydrogeology, hydro geochemistry, transport properties of the rock and surface ecosystems. It also describes various technical aspects of drilling, which comprises a significant portion of the investigations. Based on this possible programme, site-specific programmes will then be prepared and adapted to the site-specific questions and conditions on the specific candidate area. The main product of the investigations is a site description. This document presents an integrated description of the site (geosphere and biosphere) and its regional environs with respect to current state and naturally ongoing processes. Provided that the initial site investigation shows that the site is still favourable, complete investigations are commenced. Primary investigation data are stored in SKB's database SICADA. The database's primary data mainly represent parameter values for single measurement points or limited measurement objects. Primary data are subjected to both discipline-specific and integrated analysis and interpretation in order to be able to subdivide the site into suitable geometric units and to assign discipline-specific properties to these geometric units. In this way a three-dimensional, primarily geo scientific, site-descriptive model of rock and ground is built. The site-descriptive model is represented with the aid of both geographic information systems (GIS) and above all SKB's CAD-based computer tool, Rock Visualization System (RVS). RVS is also used as an active instrument in the interpretation of information, especially to be able to judge the relative locations of different deformation zones. When the site has been selected, the investigations are focused on characterizing conditions at depth

Site investigations. Investigation methods and general execution programme

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-01-01

SKB plans to commence site investigations in 2002. The present report is a broadening of the general programme and describes the execution of the investigations in so-called discipline-specific programmes for the disciplines geology, rock mechanics, thermal properties, hydrogeology, hydro geochemistry, transport properties of the rock and surface ecosystems. It also describes various technical aspects of drilling, which comprises a significant portion of the investigations. Based on this possible programme, site-specific programmes will then be prepared and adapted to the site-specific questions and conditions on the specific candidate area. The main product of the investigations is a site description. This document presents an integrated description of the site (geosphere and biosphere) and its regional environs with respect to current state and naturally ongoing processes. Provided that the initial site investigation shows that the site is still favourable, complete investigations are commenced. Primary investigation data are stored in SKB's database SICADA. The database's primary data mainly represent parameter values for single measurement points or limited measurement objects. Primary data are subjected to both discipline-specific and integrated analysis and interpretation in order to be able to subdivide the site into suitable geometric units and to assign discipline-specific properties to these geometric units. In this way a three-dimensional, primarily geo scientific, site-descriptive model of rock and ground is built. The site-descriptive model is represented with the aid of both geographic information systems (GIS) and above all SKB's CAD-based computer tool, Rock Visualization System (RVS). RVS is also used as an active instrument in the interpretation of information, especially to be able to judge the relative locations of different deformation zones. When the site has been selected, the investigations are focused on characterizing

Innovation strategies for generic drug companies: moving into supergenerics.

Science.gov (United States)

Ross, Malcolm S F

2010-04-01

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

Waste migration in shallow burial sites under unsaturated flow conditions

International Nuclear Information System (INIS)

Eicholz, G.G.; Whang, J.

1987-01-01

Unsaturated conditions prevail in many shallow-land burial sites, both in arid and humid regions. Unless a burial site is allowed to flood and possibly overflow, a realistic assessment of any migration scenario must take into account the conditions of unsaturated flow. These are more difficult to observe and to model, but introduce significant changes into projected rates of waste leaching and waste migration. Column tests have been performed using soils from the Southeastern coastal plain to observe the effects of varying degrees of ''unsaturation'' on the movement of radioactive tracers. The moisture content in the columns was controlled by maintaining various levels of hydrostatic suction on soil columns whose hydrodynamic characteristics had been determined carefully. Tracer tests, employing Cs-137, I-131 and Ba-133 were used to determine migration profiles and to follow their movement down the column for different suction values. A calculational model has been developed for unsaturated flow and seems to match the observations fairly well. It is evident that a full description of migration processes must take into account the reduced migration rates under unsaturated conditions and the hysteresis effects associated with wetting-drying cycles

Adaptive evolution of transcription factor binding sites

Directory of Open Access Journals (Sweden)

Berg Johannes

2004-10-01

Full Text Available Abstract Background The regulation of a gene depends on the binding of transcription factors to specific sites located in the regulatory region of the gene. The generation of these binding sites and of cooperativity between them are essential building blocks in the evolution of complex regulatory networks. We study a theoretical model for the sequence evolution of binding sites by point mutations. The approach is based on biophysical models for the binding of transcription factors to DNA. Hence we derive empirically grounded fitness landscapes, which enter a population genetics model including mutations, genetic drift, and selection. Results We show that the selection for factor binding generically leads to specific correlations between nucleotide frequencies at different positions of a binding site. We demonstrate the possibility of rapid adaptive evolution generating a new binding site for a given transcription factor by point mutations. The evolutionary time required is estimated in terms of the neutral (background mutation rate, the selection coefficient, and the effective population size. Conclusions The efficiency of binding site formation is seen to depend on two joint conditions: the binding site motif must be short enough and the promoter region must be long enough. These constraints on promoter architecture are indeed seen in eukaryotic systems. Furthermore, we analyse the adaptive evolution of genetic switches and of signal integration through binding cooperativity between different sites. Experimental tests of this picture involving the statistics of polymorphisms and phylogenies of sites are discussed.

Integration of generic issues

International Nuclear Information System (INIS)

Thatcher, D.

1989-01-01

The NRC has recognized the need to integrate generic issues (GIs). The GI process includes a number of phases, all of which should recognize the potential for overlap and conflict among related issues. In addition to the issues themselves, other related NRC and industry programs and activities need to be factored into the GI process. Integration has taken place, or is taking place, for a number of GIs. Each case of integration involves a specific set of circumstances and, as a result, the way in which integration proceeds can vary. This paper discusses the integration of issues in the generic issue process and provides a number of examples

Application of biomarkers to assess the condition of European Marine Sites

Energy Technology Data Exchange (ETDEWEB)

Hagger, Josephine A., E-mail: j.hagger@exeter.ac.u [School of Biosciences, University of Exeter, Prince of Wales Road, Exeter, Devon EX4 4PS (United Kingdom); Galloway, Tamara S. [School of Biosciences, University of Exeter, Prince of Wales Road, Exeter, Devon EX4 4PS (United Kingdom); Langston, William J. [Marine Biological Association, Citadel Hill, Plymouth PL1 2PB, Devon (United Kingdom); Jones, Malcolm B. [School of Biological Sciences, University of Plymouth, Drake Circus, Plymouth PL4 8AA, Devon (United Kingdom)

2009-07-15

A series of European Marine Sites has been designated as Special Areas of Conservation (SAC) in England. The aim of this study was to develop a practical methodology to assess the condition of SACs by applying a suite of biomarkers. Biomarkers were applied to the blue mussel Mytilus edulis and the shore crab Carcinus maenas from the Fal and Helford SAC (Cornwall). Individual biomarkers provided useful diagnostic information on the activity of certain classes of contaminants and an integrated Biomarker Response Index (BRI) was used to achieve a more holistic understanding of the condition of the SAC. The BRI indicated that the general health of both organisms was impacted in the upper part of the SAC (Fal Estuary) which correlated well with known chemical hotspots and sources of contamination. The BRI allows a pragmatic way to prioritise SAC sites that may require further investigative studies. - A suite of biomarkers was successfully used to create a Biomarker Response Index to assess the health of aquatic organisms from European Marine Sites.

Application of biomarkers to assess the condition of European Marine Sites

International Nuclear Information System (INIS)

Hagger, Josephine A.; Galloway, Tamara S.; Langston, William J.; Jones, Malcolm B.

2009-01-01

A series of European Marine Sites has been designated as Special Areas of Conservation (SAC) in England. The aim of this study was to develop a practical methodology to assess the condition of SACs by applying a suite of biomarkers. Biomarkers were applied to the blue mussel Mytilus edulis and the shore crab Carcinus maenas from the Fal and Helford SAC (Cornwall). Individual biomarkers provided useful diagnostic information on the activity of certain classes of contaminants and an integrated Biomarker Response Index (BRI) was used to achieve a more holistic understanding of the condition of the SAC. The BRI indicated that the general health of both organisms was impacted in the upper part of the SAC (Fal Estuary) which correlated well with known chemical hotspots and sources of contamination. The BRI allows a pragmatic way to prioritise SAC sites that may require further investigative studies. - A suite of biomarkers was successfully used to create a Biomarker Response Index to assess the health of aquatic organisms from European Marine Sites.

Effects of earthquake rupture shallowness and local soil conditions on simulated ground motions

International Nuclear Information System (INIS)

Apsel, Randy J.; Hadley, David M.; Hart, Robert S.

1983-03-01

The paucity of strong ground motion data in the Eastern U.S. (EUS), combined with well recognized differences in earthquake source depths and wave propagation characteristics between Eastern and Western U.S. (WUS) suggests that simulation studies will play a key role in assessing earthquake hazard in the East. This report summarizes an extensive simulation study of 5460 components of ground motion representing a model parameter study for magnitude, distance, source orientation, source depth and near-surface site conditions for a generic EUS crustal model. The simulation methodology represents a hybrid approach to modeling strong ground motion. Wave propagation is modeled with an efficient frequency-wavenumber integration algorithm. The source time function used for each grid element of a modeled fault is empirical, scaled from near-field accelerograms. This study finds that each model parameter has a significant influence on both the shape and amplitude of the simulated response spectra. The combined effect of all parameters predicts a dispersion of response spectral values that is consistent with strong ground motion observations. This study provides guidelines for scaling WUS data from shallow earthquakes to the source depth conditions more typical in the EUS. The modeled site conditions range from very soft soil to hard rock. To the extent that these general site conditions model a specific site, the simulated response spectral information can be used to either correct spectra to a site-specific environment or used to compare expected ground motions at different sites. (author)

Entry decisions in the generic pharmaceutical industry.

Science.gov (United States)

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.

Rigidity of complete generic shrinking Ricci solitons

Science.gov (United States)

Chu, Yawei; Zhou, Jundong; Wang, Xue

2018-01-01

Let (Mn , g , X) be a complete generic shrinking Ricci soliton of dimension n ≥ 3. In this paper, by employing curvature inequalities, the formula of X-Laplacian for the norm square of the trace-free curvature tensor, the weak maximum principle and the estimate of the scalar curvature of (Mn , g) , we prove some rigidity results for (Mn , g , X) . In particular, it is showed that (Mn , g , X) is isometric to Rn or a finite quotient of Sn under a pointwise pinching condition. Moreover, we establish several optimal inequalities and classify those shrinking solitons for equalities.

Generic Assessment Criteria for human health risk assessment of potentially contaminated land in China.

Science.gov (United States)

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.

South African patient's acceptance of generic drugs

African Journals Online (AJOL)

mechanism in this regard for final consumers, insurance providers, and ... facilities are viewed as inferior, treated with sus- picion and ... to choose a generic drug if the decision was supported by their doctor ... The effect of brand to generic and ...

Impact of generic substitution decision support on electronic prescribing behavior.

Science.gov (United States)

Stenner, Shane P; Chen, Qingxia; Johnson, Kevin B

2010-01-01

To evaluate the impact of generic substitution decision support on electronic (e-) prescribing of generic medications. The authors analyzed retrospective outpatient e-prescribing data from an academic medical center and affiliated network for July 1, 2005-September 30, 2008 using an interrupted time-series design to assess the rate of generic prescribing before and after implementing generic substitution decision support. To assess background secular trends, e-prescribing was compared with a concurrent random sample of hand-generated prescriptions. Proportion of generic medications prescribed before and after the intervention, evaluated over time, and compared with a sample of prescriptions generated without e-prescribing. The proportion of generic medication prescriptions increased from 32.1% to 54.2% after the intervention (22.1% increase, 95% CI 21.9% to 22.3%), with no diminution in magnitude of improvement post-intervention. In the concurrent control group, increases in proportion of generic prescriptions (29.3% to 31.4% to 37.4% in the pre-intervention, post-intervention, and end-of-study periods, respectively) were not commensurate with the intervention. There was a larger change in generic prescribing rates among authorized prescribers (24.6%) than nurses (18.5%; adjusted OR 1.38, 95% CI 1.17 to 1.63). Two years after the intervention, the proportion of generic prescribing remained significantly higher for e-prescriptions (58.1%; 95% CI 57.5% to 58.7%) than for hand-generated prescriptions ordered at the same time (37.4%; 95% CI 34.9% to 39.9%) (p<0.0001). Generic prescribing increased significantly in every specialty. Implementation of generic substitution decision support was associated with dramatic and sustained improvements in the rate of outpatient generic e-prescribing across all specialties.

Generic Graph Grammar: A Simple Grammar for Generic Procedural Modelling

DEFF Research Database (Denmark)

Christiansen, Asger Nyman; Bærentzen, Jakob Andreas

2012-01-01

in a directed cyclic graph. Furthermore, the basic productions are chosen such that Generic Graph Grammar seamlessly combines the capabilities of L-systems to imitate biological growth (to model trees, animals, etc.) and those of split grammars to design structured objects (chairs, houses, etc.). This results...

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

Science.gov (United States)

Hollis, Aidan

2002-12-01

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

Comparison between Utility of the Thai Pediatric Quality of Life Inventory 4.0 Generic Core Scales and 3.0 Cerebral Palsy Module

Science.gov (United States)

Tantilipikorn, Pinailug; Watter, Pauline; Prasertsukdee, Saipin

2013-01-01

Health-related quality of life (HRQOL) is increasingly being considered in the management of patients with various conditions. HRQOL instruments can be broadly classified as generic or disease-specific measures. Several generic HRQOL instruments in different languages have been developed for paediatric populations including the Pediatric Quality…

Generic substitution of antiretrovirals: patients' and health care providers' opinions.

Science.gov (United States)

Kieran, Jennifer A; O'Reilly, Eimear; O'Dea, Siobhan; Bergin, Colm; O'Leary, Aisling

2017-10-01

There is interest in introducing generic antiretroviral drugs (ARVs) into high-income countries in order to maximise efficiency in health care budgets. Studies examining patients' and providers' knowledge and attitudes to generic substitution in HIV are few. This was a cross-sectional, observational study with a convenience sample of adult HIV-infected patients and health care providers (HCPs). Data on demographics, knowledge of generic medicine and facilitators of generic substitution were collected. Descriptive and univariate analysis was performed using SPSS V.23™. Questionnaires were completed by 66 patients. Seventy-one per cent would have no concerns with the introduction of generic ARVs. An increase in frequency of administration (61%) or pill burden (53%) would make patients less likely to accept generic ARVs. There were 30 respondents to the HCP survey. Concerns included the supply chain of generics, loss of fixed dose combinations, adherence and use of older medications. An increase in dosing frequency (76%) or an increase in pill burden (50%) would make HCPs less likely to prescribe a generic ARV. The main perceived advantage was financial. Generic substitution of ARVs would be acceptable to the majority of patients and HCPs. Reinvesting savings back into HIV services would facilitate the success of such a programme.

Benefits of Digital Equipment Generic Qualification Activities

International Nuclear Information System (INIS)

Thomas, James E.; Steiman, Samuel C.

2002-01-01

As a result of nuclear power plant instrumentation and control obsolescence issues, there have been numerous activities during recent years relating to the qualification of digital equipment. Some of these activities have been 'generic' in nature in that the qualification was not limited to plant specific applications, but was intended to cover a broad base of potential applications of the digital equipment. These generic qualifications have been funded by equipment manufacturers and by utility groups and organizations. The generic activities sponsored by the Electric Power Research Institute (EPRI) have been pilot projects for an overall generic qualification approach. The primary benefit resulting from the generic qualification work to date is that a number of digital platforms and digital devices are now available for use in various nuclear safety-related applications. Many of the tests and evaluations necessary to support plant specific applications have been completed. The amount of data and documentation that each utility must develop on a case by case basis has been significantly reduced. There are also a number of additional benefits resulting from these industry efforts. The challenges and difficulties in qualifying digital equipment for safety-related applications are now more clearly understood. EPRI has published a lessons learned document (EPRI Report 1001452, Generic Qualification of Commercial Grade Digital Devices: Lessons Learned from Initial Pilots, which covers several different qualification areas, including device selection, project planning, vendor surveys and design reviews, and electromagnetic compatibility (EMC) qualification. Application of the experience and lessons learned from the EPRI pilot activities should help reduce the effort and cost required for future qualification work. Most generic qualification activities for commercial equipment have been conducted using the approach of EPRI TR-106439, Guideline on Evaluation and Acceptance

Patient knowledge, perceptions, and acceptance of generic medicines: a comprehensive review of the current literature

Directory of Open Access Journals (Sweden)

Alrasheedy AA

2014-04-01

such misconceptions varied from one country to another. However, in many countries, there was a meaningful percentage of patients who had negative perceptions and misconceptions about generic medicines. Moreover, such misconceptions and negative perceptions were reported as major obstacles to the use and acceptance of generic medicines among patients. Further, studies that focused on specific populations (eg, patients with epilepsy, psychosis, or renal disease reported a more negative perception and more resistance to the use of generic medicines. The type of medical condition and its level of seriousness or severity, recommendations by health care professionals, price difference (ie, cost saving, previous experience of generic medicines, and knowledge/information about generic medicines were considered to be important factors that affect a patient’s decision to use a generic medicine or a brand medicine. Conclusion: The results from this literature search show that patients and medicine consumers tend to prefer original brand medicines over generic medicines. Further, in many countries, there is still a considerable proportion of patients and consumers who lack adequate knowledge or have insufficient information about generic medicines. Thus, there is a need for educational interventions and activities to educate patients about generic medicines. It is also evident in the literature that health care professionals (physicians and pharmacists play a key role in the promotion of generic medicines and in patients’ acceptance of generic medicines and generic substitution. Hence, health care professionals need to play a more active role by educating patients and recommending generic medicines to their patients. Keywords: patients, generic substitution, perceptions, policy

Generic analysis of kinetically driven inflation

Science.gov (United States)

Saitou, Rio

2018-04-01

We perform a model-independent analysis of kinetically driven inflation (KDI) which (partially) includes generalized G-inflation and ghost inflation. We evaluate the background evolution splitting into the inflationary attractor and the perturbation around it. We also consider the quantum fluctuation of the scalar mode with a usual scaling and derive the spectral index, ignoring the contribution from the second-order products of slow-roll parameters. Using these formalisms, we find that within our generic framework the models of KDI which possess the shift symmetry of scalar field cannot create the quantum fluctuation consistent with the observation. Breaking the shift symmetry, we obtain a few essential conditions for viable models of KDI associated with the graceful exit.

Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Science.gov (United States)

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.

Engineering study of generic site criteria for selected DOE plutonium facilities

International Nuclear Information System (INIS)

Kingsbury, R.J.; Greenwood, J.M.; Sandoval, M.D.

1980-09-01

The objectives of this study were to identify criteria that would be applied to selection of a site for plutonium facilities such as those at the Rocky Flats Plant, to establish the relative importance of these criteria, and to identify suitable areas within the United States for location of plutonium facilities with respect to these criteria. Sources of the site criteria identified include federal laws, federal agency regulations, state laws and regulations, and requirements associated with operations to be performed at the site. The criteria identified during the study were organized into 14 major categories. The relative importnace of each category and each criterion within the categories were established using group decision-making techniques. The major criteria categories, their assigned weight on a scale of 1 to 10, and their relative priority ranks are as follows: geology/seismicity; public safety; environmental impact; meteorology; hydrology; topography; transportation; utilities; personnel; safeguards/security; land area and availability; land use compatibility; and, public acceptance. A suitability analysis of the continental United States was performed using only those criteria that could be mapped at a national scale. Suitability was assessed with respect to each of these criteria, and individual suitability maps were prepared. A composite suitability map was generated using computerized overlay techniques. This map provides a starting point for identifying specific candidate sites if an actual site selection were to be conducted

Policies and perceptions on generic drugs: The case of Greece.

Science.gov (United States)

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.

Application of biosphere models in the Biomosa project: a comparative assessment of five European radioactive waste disposal sites

International Nuclear Information System (INIS)

Kowe, R.; Mobbs, S.; Proehl, G.; Bergstrom, U.; Kanyar, B.; Olyslaegers, G.; Zeevaert, T.; Simon, I.

2004-01-01

The BIOMOSA (Biosphere Models for Safety Assessment of Radioactive Waste Disposal) project is a part of the EC fifth framework research programme. The main goal of this project is the improvement of the scientific basis for the application of biosphere models in the framework of long-term safety studies of radioactive waste disposal facilities. Furthermore, the outcome of the project will provide operators and regulatory bodies with guidelines for performance assessments of repository systems. The study focuses on the development and application of site-specific models and a generic biosphere tool BIOGEM (Biosphere Generic Model), using the experience from the national programmes and the IAEA BIOMASS reference biosphere methodology. The models were applied to 5 typical locations in the EU, resulting in estimates of the annual individual doses to the critical groups and the ranking of the importance of the pathways for each of the sites. The results of the site-specific and generic models were then compared. In all cases the doses calculated by the generic model were less than the doses obtained from the site-specific models. Uncertainty in the results was estimated by means of stochastic calculations which allow a comparison of the overall model uncertainty with the variability across the different sites considered. (author)

Early Site Permit Demonstration Program: Plant parameters envelope report. Volume 1

Energy Technology Data Exchange (ETDEWEB)

1993-03-01

The Early Site Permit (ESP) Demonstration Program is the nuclear industry`s initiative for piloting the early resolution of siting-related issues before the detailed design proceedings of the combined operating license review. The ESP Demonstration Program consists of three phases. The plant parameters envelopes task is part of Phase 1, which addresses the generic review of applicable federal regulations and develops criteria for safety and environmental assessment of potential sites. The plant parameters envelopes identify parameters that characterize the interface between an ALWR design and a potential site, and quantify the interface through values selected from the Utility Requirements Documents, vendor design information, or engineering assessments. When augmented with site-specific information, the plant parameters envelopes provide sufficient information to allow ESPs to be granted based on individual ALWR design information or enveloping design information for the evolutionary, passive, or generic ALWR plants. This document is expected to become a living document when used by future applicants.

HTGR generic technology program plan (FY 80)

International Nuclear Information System (INIS)

1980-01-01

Purpose of the program is to develop base technology and to perform design and development common to the HTGR Steam Cycle, Gas Turbine, and Process Heat Plants. The generic technology program breaks into the base technology, generic component, pebble-bed study, technology transfer, and fresh fuel programs

Societal value of generic medicines beyond cost-saving through reduced prices.

Science.gov (United States)

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.

Estimation of Wave Conditions at Svåheia SSG Pilot Site

DEFF Research Database (Denmark)

Kofoed, Jens Peter; Margheritini, Lucia; Stratigaki, V.

The purpose of the project described in the present report is to estimate the local wave conditions at the proposed location for a SSG pilot at the Svåheia site in the south western part of Norway. Focus is put on estimating the everyday conditions to enable an evaluation of the power production...... potential for the SSG pilot at the proposed location. The work in the project has been performed in three parts: 1. Establishing the offshore wave conditions and bathymetry of the area. 2. Transformation of offshore waves to near shore, through numerical wave modeling. 3. Evaluation of the transformed...... (local) wave conditions and its implications....

Generic switching of warfarin and risk of excessive anticoagulation

DEFF Research Database (Denmark)

Hellfritzsch, Maja; Rathe, Jette; Stage, Tore Bjerregaard

2016-01-01

PURPOSE: Generic switching of warfarin was recently repealed in Denmark, as adverse drug reaction (ADR) reports suggested risk of excessive anticoagulation following switches from branded to generic warfarin. We investigated this putative association in a formalized pharmacoepidemiological analysis....... METHODS: We conducted a nationwide cohort study based on Danish healthcare registries, including data from the introduction of generic warfarin until the repeal (January 2011-April 2015). We followed Danish warfarin users over time and compared the rate of incident hospitalizations due to excessive...... anticoagulation (i.e. increased INR or any bleeding requiring hospitalization) in periods following a recent switch to generic warfarin to the rate in periods without a recent switch. RESULTS: We included 105,751 warfarin users, filling a total of 1,539,640 prescriptions for warfarin (2.5% for generic warfarin...

Generic communications index. Listings of communications 1971-1989

Energy Technology Data Exchange (ETDEWEB)

Hagemeyer, D; Towle, H

1991-05-01

As part of its program to feed back information on operating experience to industry, the U.S. Nuclear Regulatory Commission (NRC) issues generic communications called bulletins (about 5/yr), circulars (now discontinued), generic letters (about 20/yr), and information notices (about 100/yr). The report presents an updated Generic Communications Index (GCI; previously published in NUREG/CR-4690, Vol. 1, December 1987) of all such communications from 1971, when such documentation started, to 1989. The GCI consists of records, one for each communication, containing fields for identification number, title, NRC technical contact, general system or topic, specific component or topic, cause or defect, potential effect, remarks, and vendors involved. To facilitate information retrieval, the report also contains topical listings of generic communications numbers. (author)

Application of the ICRP approach for radiological protection of the marine environment in generic impact assessments

Energy Technology Data Exchange (ETDEWEB)

Kliaus, Viktoryia [Republican Scientific-Practical Centre of Hygiene, Laboratory of Radiation Safety, Akademicheskaya str. 8, 220012, Minsk (Belarus); Telleria, Diego M. [IAEA-Assessment and Management of Environmental Releases Unit, Wagramer Strasse 5 - PO Box 100, A-1400, Vienna (Austria); Cabianca, Tiberio [Centre for Radiation, Chemical and Environmental Hazards, PHE, Chilton, Didcot, Oxfordshire OX11 0RQ (United Kingdom)

2014-07-01

This paper presents a way to use the ICRP approach for protection of the environment in generic assessments of the radiological impact of radioactive releases to the marine environment. Generic assessments of radiological impact to the environment are needed in certain circumstances, for example, when input data are limited or when the likely radiological consequences are expected to be not significant. Under these circumstances the effort in performing the assessment must be commensurate with the potential radiological consequences. The generic assessment described in this paper is a simple tool which provides reasonable and cautious results and is applicable to multiple exposure scenarios associated with the assessment of the radiological impact of releases to the marine the environment. This generic assessment can be also used to provide preliminary results which, when compared to radiological criteria, may determine the need of further specific assessments. The ICRP based its approach to protect the environment in the definition of a set of reference animals and plants and the use of related radiological criteria, in the form of derived consideration reference levels. The paper discusses selection and exposure conditions of the reference animals and plants, methods to estimate their doses and the use of the radiological criteria, for the purpose of a generic assessment. The IAEA is elaborating applications of these generic impact assessments presented in the paper to be included in international guidance under development. (authors)

The short-term impact of Ontario's generic pricing reforms.

Directory of Open Access Journals (Sweden)

Michael R Law

Full Text Available 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.

17 CFR 230.135a - Generic advertising.

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Generic advertising. 230.135a Section 230.135a Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION GENERAL RULES AND REGULATIONS, SECURITIES ACT OF 1933 General § 230.135a Generic advertising. (a) For the purposes only of...

78 FR 59911 - Generic Information Collection for Land Management Planning

Science.gov (United States)

2013-09-30

... DEPARTMENT OF AGRICULTURE Forest Service Generic Information Collection for Land Management... organizations on the proposed information collection, Generic Information Collection for Land Management... related to forest management. The intent of this generic information collection request (ICR) is to...

Generic substitution: micro evidence from register data in Norway.

Science.gov (United States)

Dalen, Dag Morten; Furu, Kari; Locatelli, Marilena; Strøm, Steinar

2011-02-01

The importance of prices, doctor and patient characteristics, and market institutions for the likelihood of choosing generic drugs instead of the more expensive original brand-name version are examined. Using an extensive dataset extracted from The Norwegian Prescription Database containing all prescriptions dispensed to individuals in February 2004 and 2006 on 23 different drugs (chemical substances) in Norway, we find strong evidence for the importance of both doctor and patient characteristics for the choice probabilities. The price difference between brand and generic versions and insurance coverage both affect generic substitution. Moreover, controlling for the retail chain affiliation of the dispensing pharmacy, we find that pharmacies play an important role in promoting generic substitution. In markets with more recent entry of generic drugs, brand-name loyalty proves to be much stronger, giving less explanatory power to our demand model.

A generic double-curvature piezoelectric shell energy harvester: Linear/nonlinear theory and applications

Science.gov (United States)

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.

Generic drug policy in Australia: a community pharmacy perspective

Science.gov (United States)

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

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system.

Science.gov (United States)

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

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

Science.gov (United States)

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

2017-12-01

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

Generic physical protection logic trees

International Nuclear Information System (INIS)

Paulus, W.K.

1981-10-01

Generic physical protection logic trees, designed for application to nuclear facilities and materials, are presented together with a method of qualitative evaluation of the trees for design and analysis of physical protection systems. One or more defense zones are defined where adversaries interact with the physical protection system. Logic trees that are needed to describe the possible scenarios within a defense zone are selected. Elements of a postulated or existing physical protection system are tagged to the primary events of the logic tree. The likelihood of adversary success in overcoming these elements is evaluated on a binary, yes/no basis. The effect of these evaluations is propagated through the logic of each tree to determine whether the adversary is likely to accomplish the end event of the tree. The physical protection system must be highly likely to overcome the adversary before he accomplishes his objective. The evaluation must be conducted for all significant states of the site. Deficiencies uncovered become inputs to redesign and further analysis, closing the loop on the design/analysis cycle

Generic physical protection logic trees

Energy Technology Data Exchange (ETDEWEB)

Paulus, W.K.

1981-10-01

Generic physical protection logic trees, designed for application to nuclear facilities and materials, are presented together with a method of qualitative evaluation of the trees for design and analysis of physical protection systems. One or more defense zones are defined where adversaries interact with the physical protection system. Logic trees that are needed to describe the possible scenarios within a defense zone are selected. Elements of a postulated or existing physical protection system are tagged to the primary events of the logic tree. The likelihood of adversary success in overcoming these elements is evaluated on a binary, yes/no basis. The effect of these evaluations is propagated through the logic of each tree to determine whether the adversary is likely to accomplish the end event of the tree. The physical protection system must be highly likely to overcome the adversary before he accomplishes his objective. The evaluation must be conducted for all significant states of the site. Deficiencies uncovered become inputs to redesign and further analysis, closing the loop on the design/analysis cycle.

Do higher-priced generic medicines enjoy a competitive advantage under reference pricing?

Science.gov (United States)

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.

Comparative effectiveness of generic versus brand-name antiepileptic medications.

Science.gov (United States)

Gagne, Joshua J; Kesselheim, Aaron S; Choudhry, Niteesh K; Polinski, Jennifer M; Hutchins, David; Matlin, Olga S; Brennan, Troyen A; Avorn, Jerry; Shrank, William H

2015-11-01

The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a brand-name product. We used linked electronic medical and pharmacy claims data to identify Medicare beneficiaries who initiated one of five AEDs (clonazepam, gabapentin, oxcarbazepine, phenytoin, zonisamide). We matched initiators of generic versus brand-name versions of these drugs using a propensity score that accounted for demographic, clinical, and health service utilization variables. We used a Cox proportional hazards model to compare rates of seizure-related emergency room (ER) visit or hospitalization (primary outcome) and ER visit for bone fracture or head injury (secondary outcome) between the matched generic and brand-name initiators. We also compared treatment persistence, measured as time to first 14-day treatment gap, between generic and brand-name initiators. We identified 19,760 AED initiators who met study eligibility criteria; 18,306 (93%) initiated a generic AED. In the matched cohort, we observed 47 seizure-related hospitalizations and ER visits among brand-name initiators and 31 events among generic initiators, corresponding to a hazard ratio of 0.53 (95% confidence interval, 0.30 to 0.96). Similar results were observed for the secondary clinical endpoint and across sensitivity analyses. Mean time to first treatment gap was 124.2 days (standard deviation [sd], 125.8) for brand-name initiators and 137.9 (sd, 148.6) for generic initiators. Patients who initiated generic AEDs had fewer adverse seizure-related clinical outcomes and longer continuous treatment periods before experiencing a gap than those who initiated brand-name versions. Copyright © 2015 Elsevier Inc. All rights reserved.

A Preliminary Assessment of Daily Weather Conditions in Nuclear Site for Development of Effective Emergency Plan

International Nuclear Information System (INIS)

Han, Seok Jung; Ahn, Kwang Il

2012-01-01

A radiological emergency preparedness for nuclear sites is recognized as an important measure against anticipated severe accidents with environmental releases of radioactive materials. While there are many individual means in the emergency preparedness for nuclear accidents, one of most important means is to make a decision of evacuation or shelter of the public residents with the emergency plan zone (EPZ) of a nuclear site. In order to prepare an effective strategy for the evacuation as a basis of the emergency preparedness, it may need the understanding of atmospheric dispersion characteristics of radiation releases to the environment, mainly depending upon the weather conditions of a radiation releases location, i.e., a nuclear site. As a preliminary study for the development of an effective emergency plan, the basic features of the weather conditions of a specific site were investigated. A main interest of this study is to identify whether or not the site weather conditions have specific features helpful for a decision making of evacuation of the public residents

Generic drugs: Review and experiences from South India

Directory of Open Access Journals (Sweden)

Philip Mathew

2015-01-01

Full Text Available The cost of pharmaceuticals, as a percentage of total healthcare spending, has been rising worldwide. This has resulted in strained national budgets and a high proportion of people without access to essential medications. Though India has become a global hub of generic drug manufacturing, the expected benefits of cheaper drugs are not translating into savings for ordinary people. This is in part due to the rise of branded generics, which are marketed at a price point close to the innovator brands. Unbranded generic medicines are not finding their way into prescriptions due to issues of confidence and perception, though they are proven to be much cheaper and comparable in efficacy to branded medicines. The drug inventory of unbranded generic manufacturers fares reasonably when reviewed using the World Health Organization-Health Action International (WHO-HAI tool for analysing drug availability. Also, unbranded generic medicines are much cheaper when compared to the most selling brands and they can bring down the treatment costs in primary care and family practice. We share our experience in running a community pharmacy for an urban health center in the Pathanamthitta district of Kerala State, which is run solely on generic medicines. The drug availability at the community pharmacy was 73.3% when analyzed using WHO-HAI tool and the savings for the final consumers were up to 93.1%, when compared with most-selling brand of the same formulation.

What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs.

LENUS (Irish Health Repository)

Dunne, Suzanne S

2015-07-01

Considerable emphasis is presently being placed on usage of generic medicines by governments focussed on the potential economic benefits associated with their use. Concurrently, there is increasing discussion in the lay media of perceived doubts regarding the quality and equivalence of generic medicines. The objective of this paper is to report the outcomes of a systematic search for peer-reviewed, published studies that focus on physician, pharmacist and patient\\/consumer perspectives of generic medicines.

Macroinvertebrate-based assessment of biological condition at selected sites in the Eagle River watershed, Colorado, 2000-07

Science.gov (United States)

Zuellig, Robert E.; Bruce, James F.; Healy, Brian D.; Williams, Cory A.

2010-01-01

The U.S. Geological Survey (USGS), in cooperation with the Colorado River Water Conservation District, Eagle County, Eagle River Water and Sanitation District, Upper Eagle Regional Water Authority, Colorado Department of Transportation, City of Aurora, Town of Eagle, Town of Gypsum, Town of Minturn, Town of Vail, Vail Resorts, Colorado Springs Utilities, Denver Water, and the U.S. Department of Agriculture Forest Service (FS), compiled macroinvertebrate (73 sites, 124 samples) data previously collected in the Eagle River watershed from selected USGS and FS studies, 2000-07. These data were analyzed to assess the biological condition (that is, biologically ?degraded? or ?good?) at selected sites in the Eagle River watershed and determine if site class (for example, urban or undeveloped) described biological condition. An independently developed predictive model was applied to calculate a site-specific measure of taxonomic completeness for macroinvertebrate communities, where taxonomic completeness was expressed as the ratio of observed (O) taxa to those expected (E) to occur at each site. Macroinvertebrate communities were considered degraded at sites were O/E values were less than 0.80, indicating that at least 20 percent of expected taxa were not observed. Sites were classified into one of four classes (undeveloped, adjacent road or highway or both, mixed, urban) using a combination of riparian land-cover characteristics, examination of topographic maps and aerial imagery, screening for exceedances in water-quality standards, and best professional judgment. Analysis of variance was used to determine if site class accounted for variability in mean macroinvertebrate O/E values. Finally, macroinvertebrate taxa observed more or less frequently than expected at urban sites were indentified. This study represents the first standardized assessment of biological condition of selected sites distributed across the Eagle River watershed. Of the 73 sites evaluated, just over

How Abbott’s Fenofibrate Franchise Avoided Generic Competition

Science.gov (United States)

Downing, Nicholas S.; Ross, Joseph S.; Jackevicius, Cynthia A.; Krumholz, Harlan M.

2013-01-01

The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug’s history: Abbott, the maker of branded fenofibrate, has produced several bioequivalent reformulations, which dominate the market even though generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on our healthcare system. Abbott maintained its dominance of the fenofibrate market, in part, through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented substitution with generics of older generation products. As soon as direct generic competition seemed likely at the new dose level where substitution would be allowed, Abbott would launch another reformulation and the cycle would repeat. Our objective, using the fenofibrate example, is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications without demonstrating the superiority of next generation products. PMID:22493409

Assessment of ichthyo-fauna condition within zone of Semipalatinsk test site

International Nuclear Information System (INIS)

Mamilov, N.Sh.; Mitrofanov, I.V.; Matmuratov, S.A.

2005-01-01

The paper presents studies of biological factors and calculating morphological features for fish from the Uzunbulak and Shagan Rivers situated in the Semipalatinsk test site area. The conditions of fish habitat are characterized as favorable; however alteration of phenotypic features shows radiation water contamination. (author)

Once more the generic name Passerina Vieillot

NARCIS (Netherlands)

Oort, van E.D.

1910-01-01

The note on the generic name of the Snow-bunting by Dr. E. Hartert in this part of our periodical gives me cause to revert to the subject of my note on the generic name Passerina Vieillot and to state here, that I stand to what I have said about the rejection of this name in Zoology (Notes Leyden

Generic Reed Solomon Encorder

Directory of Open Access Journals (Sweden)

Petrus Mursanto

2006-11-01

Full Text Available Reed Solomon (RS codes is a mechanism to detect and correct burst of errors in data transmission and storage systems. It provides a solid introduction to foundation mathematical concept of Galois Field algebra and its application. With the development of digital hardware technology, the RS concepts were brought into reality, i.e. the implementation of RS codec chips. This paper presents the development steps of a generic RS encoder using VHDL. The encoder is able to handle generic width of data, variable length of information, number of error as well as variable form of primitive polynomial and generator polynomial used in the system. The design has been implemented for FPGA chip Xilinx XC3S200-5FT256 and has a better performance than commercially available equivalent encoder.

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

Science.gov (United States)

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

2013-01-01

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

[Analysis of generic drug supply in France].

Science.gov (United States)

Taboulet, F; Haramburu, F; Latry, Ph

2003-09-01

The list of generic medicines (LGM), published since 1997 by the Agence Française de Sécurité Sanitaire des Produits de Santé (AFFSSaPS), the French Medicine Agency, concerns a special part of the medicines reimbursed by the National Health Insurance (Social Security). The objectives of the present study were: i) to describe the components of this list, based on pharmaceutical, economical and therapeutic characteristics, ii) to study differences between generic and reference products (formulations, excipients, prices, etc.), iii) to analyze information on excipients provided to health care professionals. The 21st version of the LGM (April 2001) was used. Therapeutic value was retrieved from the 2001 AFSSaPS report on the therapeutic value of 4490 reimbursed medicines. Information on excipients in the LGM and the Vidal dictionary (reference prescription book in France) was compared. The products included in the LGM represent 20% of all reimbursed medicines. The mean price differences between generics and their reference products vary between 30 and 50% for more than two thirds of the generic groups. The therapeutic value of the products of the LGM was judged important in 71% of cases (vs 63% for the 4409 assessed medicines) and insufficient in 13% of cases (vs 19%). Information on excipients is often missing and sometimes erroneous. Although the LGM is regularly revised and thus the generic market in perpetual change, the 2001 cross description of this pharmaceutical market provides much informations and raises some concern.

Evaluation of generic and branded herbicides : technical report.

Science.gov (United States)

2015-03-01

As with other generic brand products in the marketplace, generic herbicides often have a lower initial product cost than : their brand-name counterparts. While the purchase price of herbicides is important to TxDOT, it is essential to look at : more ...

Leveraging consumer's behaviour to promote generic drugs in Italy.

Science.gov (United States)

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.

Effect of site conditions on ground motion and damage

Science.gov (United States)

Borcherdt, R.; Glassmoyer, G.; Andrews, M.; Cranswick, E.

1989-01-01

Results of seismologic studies conducted by the U.S. reconnaissance team in conjunction with Soviet colleagues following the tragic earthquakes of December 7, 1988, suggest that site conditions may have been a major factor in contributing to increased damage levels in Leninakan. As the potential severity of these effects in Leninakan had not been previously identified, this chapter presents results intended to provide a preliminary quantification of these effects on both damage and levels of ground motion observed in Leninakan. The article describes the damage distribution geologic setting, ground motion amplification in Leninakan, including analog amplifications and spectral amplifications. Preliminary model estimates for site response are presented. It is concluded that ground motion amplification in the 0.5-2.5-second period range was a major contributing factor to increased damage in Leninakan as compared with Kirovakan. Leninakan is located on thick water saturated alluvial deposits.

Uranium mining sites of Somair and Cominak (Niger). Situation of mission on site in may 2004, application of radiological impact and advice on the network of environmental surveillance; Sites miniers d'uranium de Somair et Cominak (Niger). Bilan de la mission sur site en mai 2004, appreciation de l'impact radiologique, et avis sur le reseau de surveillance de l'environnement

Energy Technology Data Exchange (ETDEWEB)

Servant, A.C.; Cessac, B.; Bassot, S

2005-07-01

The report presents successively the context of the two mining sites, the situation of the I.R.S.N. mission on site of may 2004, an appreciation by I.R.S.N. of sites impact on the populations, the evaluation by I.R.S.N. of associated impact to generic scenario of scrap recovery from sites by the population around. (N.C.)

Predictors of generic substitution: The role of psychological, sociodemographic, and contextual factors.

Science.gov (United States)

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 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.

Generic nuclear power plant component failure data bank

International Nuclear Information System (INIS)

Araujo Goes, A.G. de; Gibelli, S.M.O.

1988-11-01

This report consist in the development of a generic nuclear power plant component failure data bank. This data bank was implemented in a PC-XT microcomputer, IBM compatible, using the Open Access II program. Generic failure data tables for Westinghouse nuclear power plants and for general PWR power plants are presented. They are the final product of a research which included a preselection and a selection of data collected from the available sources in the library of CNEN (National Nuclear Energy Commission) and from the CIN/CNEN (Neclear Information Center). Futhermore, a proposal of evaluating models of average failure rates of pumps and valves are also presented. Through the electronic data bank one can easily have a generic view of failure rate ranges as well as failure models foe a certain component. It is very importante to develop procedures to collect and store generic failure data that can be quickly accessed, in order to update the Probabilistic Safety Study of Angra-1 and to used in studies which may have component failures of nuclear power plant safety systems. In the future, data specialization can be achieved by means of statistical calculations involving specific data collected from the operational experience of Angra-1 nuclear power plant and the generic data bank. (author) [pt

Addition of generic medication vouchers to a pharmacist academic detailing program: effects on the generic dispensing ratio in a physician-hospital organization.

Science.gov (United States)

Bhargava, Vinay; Greg, Mark E; Shields, Mark C

2010-01-01

Generic dispensing ratio (GDR) is an important measure of efficiency in pharmacy benefit management. A few studies have examined the effects of academic detailing or generic drug samples on GDR. On July 1, 2007, a physician-hospital organization (PHO) with a pay-for-performance incentive for generic utilization initiated a pilot generic medication voucher program that augmented its existing pharmacist-led academic detailing efforts. No published studies have examined the role of generic medication vouchers in promoting generic drug utilization. To determine if supplementing an existing academic detailing initiative in a PHO with a generic medication voucher program would be more effective in increasing the GDR compared with academic detailing alone. The intervention took place over the 9-month period from July 1, 2007, through March 31, 2008. Vouchers provided patients with the first fill of a 30-day supply of a generic drug at no cost to the patient for 8 specific generic medications obtained through a national community pharmacy chain. The study was conducted in a PHO composed of 7 hospitals and approximately 2,900 physicians (900 primary care providers [PCPs] and 2,000 specialists). Of the approximately 300 PCP practices, 21 practices with at least 2 physicians each were selected on the basis of high prescription volume (more than 500 pharmacy claims for the practice over a 12-month pre-baseline period) and low GDR (practice GDR less than 55% in the 12-month pre-baseline period). These 21 practices were then randomized to a control group of academic detailing alone or the intervention group that received academic detailing plus generic medication vouchers. One of 10 intervention groups declined to participate, and 2 of 11 control groups dropped out of the PHO. GDR was calculated monthly for all pharmacy claims including the 8 voucher medications. GDR was defined as the ratio of the total number of paid generic pharmacy claims divided by the total number of paid

Using Service Oriented Architecture in a Generic Virtual Power Plant

DEFF Research Database (Denmark)

Andersen, Peter Bach; Poulsen, Bjarne; Træholt, Chresten

2009-01-01

The purpose of this paper is to find and describe a suitable software framework that can be used to help implement the concept of a Generic Virtual Power Plant in the future power system. The Generic Virtual Power Plant concept, along with the utilization of distributed energy resources, has many...... the Generic Virtual Power Plant, an array of different software design principles, patterns and architectures must be applied. Especially Service Oriented Architecture (SOA) can aid in implementing the Generic Virtual Power Plant.......The purpose of this paper is to find and describe a suitable software framework that can be used to help implement the concept of a Generic Virtual Power Plant in the future power system. The Generic Virtual Power Plant concept, along with the utilization of distributed energy resources, has many...... interesting properties that can influence the future shape of power markets. The concept holds many promises including cheaper power to the consumer, a more flexible and responsive power production and the support of a more environment-friendly development. In order to realize a software solution supporting...

Evaluation of Final Radiological Conditions at Areas of the Niagara Falls Storage Site Remediated under the Formerly Utilized Sites Remedial Action Program -12184

Energy Technology Data Exchange (ETDEWEB)

Clayton, Christopher [U.S Department of Energy Office of Legacy Management, Washington, DC; Kothari, Vijendra [U.S Department of Energy Office of Legacy Management, Morgantown, West Virginia; Starr, Ken [U.S Department of Energy Office of Legacy Management, Westminster, Colorado; Widdop, Michael; Gillespie, Joey [SM Stoller Corporation, Grand Junction, Colorado

2012-02-26

The U. S. Department of Energy (DOE) methods and protocols allow evaluation of remediation and final site conditions to determine if remediated sites remain protective. Two case studies are presented that involve the Niagara Falls Storage Site (NFSS) and associated vicinity properties (VPs), which are being remediated under the Formerly Utilized Sites Remedial Action Program (FUSRAP). These properties are a part of the former Lake Ontario Ordnance Works (LOOW). In response to stakeholders concerns about whether certain remediated NFSS VPs were putting them at risk, DOE met with stakeholders and agreed to evaluate protectiveness. Documentation in the DOE records collection adequately described assessed and final radiological conditions at the completed VPs. All FUSRAP wastes at the completed sites were cleaned up to meet DOE guidelines for unrestricted use. DOE compiled the results of the investigation in a report that was released for public comment. In conducting the review of site conditions, DOE found that stakeholders were also concerned about waste from the Separations Process Research Unit (SPRU) at the Knolls Atomic Power Laboratory (KAPL) that was handled at LOOW. DOE agreed to determine if SPRU waste remained at that needed to be remediated. DOE reviewed records of waste characterization, historical handling locations and methods, and assessment and remediation data. DOE concluded that the SPRU waste was remediated on the LOOW to levels that pose no unacceptable risk and allow unrestricted use and unlimited exposure. This work confirms the following points as tenets of an effective long-term surveillance and maintenance (LTS&M) program: Stakeholder interaction must be open and transparent, and DOE must respond promptly to stakeholder concerns. DOE, as the long-term custodian, must collect and preserve site records in order to demonstrate that remediated sites pose no unacceptable risk. DOE must continue to maintain constructive relationships with the U

Generic tacrolimus in solid organ transplantation

DEFF Research Database (Denmark)

Taube, D; Jones, G; O'Beirne, J

2014-01-01

The availability of a wide range of immunosuppressive therapies has revolutionized the management of patients who have undergone solid organ transplantation (SOT). However, the cost of immunosuppressive drugs remains high. This situation has led to the development of generic equivalents, which...... innovator tacrolimus drug (Prograf) in both healthy volunteers and kidney transplant patients. Clinical experience with this generic tacrolimus formulation has also been established in both de novo and conversion patients who have undergone kidney and liver transplantation, as well as in conversion of other...

Generic immunosuppression in transplantation: current evidence and controversial issues.

Science.gov (United States)

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

2015-05-01

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

Lawsuits allege price fixing by generic drug makers

Directory of Open Access Journals (Sweden)

Robbins RA

2016-12-01

Full Text Available No abstract available. Article truncated at 150 words. Two years after high generic drug prices became a public controversy, Reuters is reporting that 20 states filed a lawsuit Thursday against Mylan, Teva Pharmaceuticals and four other generic drug makers (1. The suit alleges the companies conspired to fix prices or allocated markets to prop up prices. The civil lawsuit, led by antitrust investigators in Connecticut, comes one day after the U.S. Department of Justice filed criminal charges against two former executives of the generic drug maker, Heritage. The states attorneys general asked the court to order the companies to disgorge ill-gotten gains, which were not defined, pay attorneys' fees and stop collusion. Of the states in the Southwest only Nevada is participating in the lawsuit. The cases are part of a broader generic drug pricing probe that remains under way at the state and federal level, as well as in the U.S. Congress. In 2014, media reports of …

Soil microbial diversity, site conditions, shelter forest land, saline water drip-irrigation, drift desert.

Science.gov (United States)

Jin, Zhengzhong; Lei, Jiaqiang; Li, Shengyu; Xu, Xinwen

2013-10-01

Soil microbes in forest land are crucial to soil development in extreme areas. In this study, methods of conventional culture, PLFA and PCR-DGGE were utilized to analyze soil microbial quantity, fatty acids and microbial DNA segments of soils subjected to different site conditions in the Tarim Desert Highway forest land. The main results were as follows: the soil microbial amount, diversity indexes of fatty acid and DNA segment differed significantly among sites with different conditions (F 84%), followed by actinomycetes and then fungi (<0.05%). Vertical differences in the soil microbial diversity were insignificant at 0-35 cm. Correlation analysis indicated that the forest trees grew better as the soil microbial diversity index increased. Therefore, construction of the Tarim Desert Highway shelter-forest promoted soil biological development; however, for enhancing sand control efficiency and promoting sand development, we should consider the effects of site condition in the construction and regeneration of shelter-forest ecological projects. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Mixed WTO ruling on generic drug development.

Science.gov (United States)

Elliott, R

2000-01-01

On 17 March 2000, the World Trade Organization upheld the provision in Canada's patent laws that allows generic drug manufacturers to develop (but not sell) their cheaper versions of patented medicines before the 20-year patients expire. The decision prevents pharmaceutical companies from enjoying market monopolies beyond their patent terms, avoiding what would otherwise be even lengthier delays in the sale of cheaper, generic drugs in Canada. This decision is of significance not only to Canada, but also to other WTO member countries and to all individuals who use pharmaceutical products. However, the decision is not all positive: the WTO also ruled that Canada is violating international agreements by letting generic manufacturers stockpile their versions of patented drugs before patents expire. This article explains the issues, the arguments, and the decision.

40 CFR 721.10036 - Acetaldehyde based polymer (generic).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Acetaldehyde based polymer (generic... Specific Chemical Substances § 721.10036 Acetaldehyde based polymer (generic). (a) Chemical substance and... based polymer (PMN P-02-406) is subject to reporting under this section for the significant new uses...

Enhancing Safety through Generic Competencies

Directory of Open Access Journals (Sweden)

S. Mockel

2014-03-01

Full Text Available This article provides insights into proactive safety management and mitigation. An analysis of accident reports reveals categories of supervening causes of accidents which can be directly linked to the concept of generic competencies (information management, communication and coordination, problem solving, and effect control. These findings strongly suggest adding the human element as another safety-constituting pillar to the concept of ship safety next to technology and regulation. We argue that the human element has unique abilities in dealing with critical and highly dynamic situations which can contribute to the system's recovery from non-routine or critical situations. By educating seafarers in generic competencies we claim to enable the people onboard to successfully deal with critical situations.

Uncertain quantities in estimating radiation exposure from former landfill sites: groundwater pathway

International Nuclear Information System (INIS)

Kistinger, S.

2005-01-01

With regard to the title of the closed meeting, ''Realistic determination of radiation exposure'', we state that generic estimates can by definition never be realistic, but that it is their purpose to be conservative. However this still leaves us with the question of how conservative a generic dose estimate must be and how the existing variability or indeterminacy of reality should be taken into account. This paper presents various methods for dealing with this indeterminacy in generic dose estimates. The example used for this purpose is a simplified model for the determination of the potential radiation exposure caused by a former landfill site via the water pathway

Generic magnetic fusion reactor cost assessment

International Nuclear Information System (INIS)

Sheffield, J.

1985-01-01

The Fusion Energy Division of the Oak Ridge National Laboratory discusses ''generic'' magnetic fusion reactors. The author comments on DT burning magnetic fusion reactor models being possibly operational in the 21st century. Representative parameters from D-T reactor studies are given, as well as a shematic diagram of a generic fusion reactor. Values are given for winding pack current density for existing and future superconducting coils. Topics included are the variation of the cost of electricity (COE), the dependence of the COE on the net electric power of the reactor, and COE formula definitions

Generic radiation safety design for SSRL synchrotron radiation beamlines

Energy Technology Data Exchange (ETDEWEB)

Liu, James C. [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States)]. E-mail: james@slac.stanford.edu; Fasso, Alberto [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States); Khater, Hesham [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States); Prinz, Alyssa [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States); Rokni, Sayed [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States)

2006-12-15

To allow for a conservative, simple, uniform, consistent, efficient radiation safety design for all SSRL beamlines, a generic approach has been developed, considering both synchrotron radiation (SR) and gas bremsstrahlung (GB) hazards. To develop the methodology and rules needed for generic beamline design, analytic models, the STAC8 code, and the FLUKA Monte Carlo code were used to pre-calculate sets of curves and tables that can be looked up for each beamline safety design. Conservative beam parameters and standard targets and geometries were used in the calculations. This paper presents the SPEAR3 beamline parameters that were considered in the design, the safety design considerations, and the main pre-calculated results that are needed for generic shielding design. In the end, the rules and practices for generic SSRL beamline design are summarized.

Beyond design basis external flooding. Generic design assessment and lessons learned from the Fukushima Dai-ichi accident

International Nuclear Information System (INIS)

MacLeod, Tanya; Smith, Leslie; Allmark, Tim; Ford, Peter

2017-01-01

New reactors intended for construction in GB undergo the Office for Nuclear Regulation's (ONR's) Generic Design Assessment (GDA). GDA is a pre-licensing process that provides requesting parties with the opportunity to demonstrate at an early stage that the design is capable of meeting the legal requirements of Great Britain. During GDA, the intended reactor site may not yet be known. Therefore, requesting parties usually define a 'Generic Site' with characteristics typical for Great Britain. These characteristics should, as far as possible, bound the characteristics of known potential sites so that reactors of the proposed type could potentially be built at various suitable locations. This paper critically reviews ONR's approach to ensuring that external flooding is appropriately addressed at the GDA stage and covers: An overview of ONR's approach to post-Fukushima assessment. Changes to ONR's SAPs (Safety Assessment Principles) related to External Flooding. Two examples of post-Fukushima GDA approaches to External Flooding. Uncertainty and the provision of adequate safety measures. The paper concludes that the identification of potential vulnerabilities in the design to external flooding combined with a consideration of post-Fukushima resilience enhancements has led to increased regulatory confidence in the robustness of new reactor designs in GB against external flooding. (author)

Acquisition system for the "EMSO Generic Instrument Module" (EGIM) and analysis of the data obtained during its first deployment at OBSEA site (Spain)

Science.gov (United States)

Garcia, Oscar; Mihai Toma, Daniel; Dañobeitia, Juanjo; del Rio, Joaquin; Bartolome, Rafael; Martínez, Enoc; Nogueras, Marc; Bghiel, Ikram; Lanteri, Nadine; Rolin, Jean Francois; Beranzoli, Laura; Favali, Paolo

2017-04-01

The EMSODEV project (EMSO implementation and operation: DEVelopment of instrument module) is an Horizon-2020 UE project whose overall objective is the operation of eleven seafloor observatories and four test sites. These infrastructures are distributed throughout European seas, from the Arctic across the Atlantic and the Mediterranean to the Black Sea, and are managed by the European consortium EMSO-ERIC (European Research Infrastructure Consortium) with the participation of 8 European countries and other associated partners. Recently, we have implemented a Generic Sensor Module (EGIM) within the EMSO-ERIC distributed marine research infrastructure. EGIM is able to operate on any EMSO observatory node, mooring line, seabed station, cabled or non-cabled and surface buoy. The main role of EGIM is to measure homogeneously a set of core variables using the same hardware, sensor references, qualification methods, calibration methods, data format and access, maintenance procedures in several European ocean locations. The EGIM module acquires a wide range of ocean parameters in a long-term consistent, accurate and comparable manner from disciplines such as biology, geology, chemistry, physics, engineering, and computer science, from polar to subtropical environments, through the water column down to the deep sea. Our work includes developing standard-compliant generic software for Sensor Web Enablement (SWE) on EGIM and to perform the first onshore and offshore test bench, to support the sensors data acquisition on a new interoperable EGIM system. EGIM in its turn is linked to an acquisition drives processes, a centralized Sensor Observation Service (SOS) server and a laboratory monitor system (LabMonitor) that records events and alarms during acquisition. The measurements recorded along EMSO NODES are essential to accurately respond to the social and scientific challenges such as climate change, changes in marine ecosystems, and marine hazards. This presentation shows

The generic strategy trap.

Science.gov (United States)

Miller, D

1992-01-01

Management experts claim that for a company to thrive, it must concentrate on a single generic strategy--on one thing it does better than its rivals. But specialization also has its disadvantages. The author suggests that a broader, mixed approach may be preferable.

Remotely operated excavator needs assessment/site visit summary

Energy Technology Data Exchange (ETDEWEB)

Straub, J.; Haller, S.; Worsley, R. [Westinghouse Environmental Management Co. of Ohio, Cincinnati, OH (United States); King, M. [THETA Technology Inc. (United States)

1992-12-02

The Uranium in Soils Integrated Demonstration requested an assessment of soil excavation needs relative to soil remediation. The following list identifies the DOE sites assessed: Mound Laboratory, Paducah Gaseous Diffusion Plant, Portsmouth Gaseous Diffusion Plant, Nevada Test Site, Lawrence Livermore National Laboratory, Rocky Flats Plant, Los Alamos National Laboratory, Sandia National Laboratory, Idaho National Engineering Laboratory, Hanford Site, and Fernald Site. The reviewed sites fall into one or more of the following three categories: production, EPA National Priorities List, or CERCLA (superfund) designation. Only three of the sites appear to have the need for a remotely operated excavator rope. Hanford and Idaho Falls have areas of high-level radioactive contamination either buried or in/under buildings. The Fernald site has a need for remote operated equipment of different types. It is their feeling that remote equipment can be used to remove the health dangers to humans by removing them from the area. Most interviewees stated that characterization technologies needs are more immediate concern over excavation. In addition, the sites do not have similar geographic conditions which would aid in the development of a generic precision excavator. The sites visited were not ready to utilize or provide the required design information necessary to draft a performance specification. This creates a strong case against the development of one type of ROPE for use at these sites. Assuming soil characterization technology/methodology is improved sufficiently to allow accurate and real time field characterization then development of a precision excavator might be pursued based on FEMP needs, since the FEMP`s sole scope of work is remediation. The excavator could then be used/tested and then later modified for other sites as warranted.

Introduction of developing a list of MSO generic scenarios for PHWR

Energy Technology Data Exchange (ETDEWEB)

Park, Jae Wan; Park, Jun Hyun; Bae, Hui Soo [STANDARD Testing and Engineering Ing. Ltd, Daejeon (Korea, Republic of)

2016-10-15

Multiple Spurious Operation(MSO) scenarios should contain scenarios threatening Post-fire safe shutdown function by MSO of Safe Shutdown Equipments(SSEs) as well as Non-SSEs. The list of MSO generic scenarios(NEI 00-01, Appendix G) was developed by industrial survey. Although not all scenarios of the list of MSO generic scenarios(NEI 00-01, Appendix G) are considered applicable to every reactor type, this list provides an input about MSO identification and treatment process. If NEI 00-01 is applied to other reactor type, analyst should review applicability of the list of generic scenarios(NEI 00-01, Appendix G) and consider potential MSO scenarios undescribed in the list of MSO generic scenarios(NEI 00-01, Appendix G). Especially, in PHWR case, there is no list of MSO generic scenarios in Canada or internationally. There are substantial physical variations between NPPs. So some generic scenarios(NEI 00-01, Appendix G) would need validation. Nevertheless, industrial stakeholder have not did any MSO work until now. In this paper, results of first stage research that develop the list of MSO generic scenarios for pressurized heavy water reactor(PHWR) is introduced. According to the review results, specific review of the list of MSO generic scenarios(NEI 00-01, Appendix G) is required such as how it applies to PHWR. And criteria was established for review of availability of the list of generic scenarios(NEI 00-01, Appendix G). However there are still many tasks such as potential scenario review, risk model review and expert panel review.

Development of a method for the comparison of final repository sites in different host rock formations; Weiterentwicklung einer Methode zum Vergleich von Endlagerstandorten in unterschiedlichen Wirtsgesteinsformationen

Energy Technology Data Exchange (ETDEWEB)

Fischer-Appelt, Klaus; Frieling, Gerd; Kock, Ingo; and others

2017-10-15

The report on the development of a method for the comparison of final repository sites in different host rock formations covers the following issues: influence of the requirement of retrievability on the methodology, study on the possible extension of the methodology for repository sites with crystalline host rocks: boundary conditions in Germany, final disposal concept for crystalline host rocks, generic extension of the VerSi method, identification, classification and relevance weighting of safety functions, relevance of the safety functions for the crystalline host rock formation, review of the methodological need for changes for crystalline rock sites under low-permeability covering; study on the applicability of the methodology for the determination of site regions for surface exploitation (phase 1).

Knowledge mobilisation in healthcare: a critical review of health sector and generic management literature.

Science.gov (United States)

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.

Frequency and Informativeness of Gestural Cues Accompanying Generic and Particular Reference

Science.gov (United States)

Meyer, Meredith; Gelman, Susan A.; Stilwell, Sarah M.

2015-01-01

Generic noun phrases, or generics, refer to abstract categories ("Dogs" bark) rather than particular individuals ("Those dogs" bark). Study 1 investigated how parents use gestures in association with generic versus particular reference during naturalistic interactions with their 2- and 3-year-old children. Parents provided…

An audit of generic prescribing in a general surgical department.

LENUS (Irish Health Repository)

Gleeson, M

2013-01-17

BACKGROUND: The Health Service Executive introduced a generic prescription policy to reduce costs. Despite this, generic prescription rates remain low. AIM: To audit in-patient prescription practice in a single surgical department and identify potential savings which could be realised by adherence to the generic prescribing policy. METHODS: Surgical in-patient charts were obtained at the point of discharge and their drug prescription information was recorded. RESULTS: 51 % of prescriptions involved a trade-name prescription where an appropriate generic equivalent existed. The cost implications for hospital and community patients were found to be greatly affected by substitution policies that exist at hospital pharmacy level. CONCLUSION: There is a need to promote greater adherence to generic prescribing amongst hospital doctors in line with international best practice. It can have a positive impact in terms of safe prescribing and can have cost implications at both hospital and community level.

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

Science.gov (United States)

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

2011-02-01

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

Impacts of generic competition and benefit management practices on spending for prescription drugs: evidence from Medicare's Part D benefit.

Science.gov (United States)

Sheingold, Steven; Nguyen, Nguyen Xuan

2014-01-01

This study estimates the effects of generic competition, increased cost-sharing, and benefit practices on utilization and spending for prescription drugs. We examined changes in Medicare price and utilization from 2007 to 2009 of all drugs in 28 therapeutic classes. The classes accounted for 80% of Medicare Part D spending in 2009 and included the 6 protected classes and 6 classes with practically no generic competition. All variables were constructed to measure each drug relative to its class at a specific plan sponsor. We estimated that the shift toward generic utilization had cut in half the rate of increase in the price of a prescription during 2007-2009. Specifically, the results showed that (1) rapid generic penetration had significantly held down costs per prescription, (2) copayment and other benefit practices shifted utilization to generics and favored brands, and (3) price increases were generally greater in less competitive classes of drugs. In many ways, Part D was implemented at a fortuitous time; since 2006, there have been relatively few new blockbuster drugs introduced, and many existing high-volume drugs used by beneficiaries were in therapeutic classes with multiple brands and generic alternatives. Under these conditions, our paper showed that plan sponsors have been able to contain costs by encouraging use of generics or drugs offering greater value within therapeutic classes. It is less clear what will happen to future Part D costs if a number of new and effective drugs for beneficiaries enter the market with no real competitors.

A generic coding approach for the examination of meal patterns.

Science.gov (United States)

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

2015-08-01

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

Pointing As a Socio-Pragmatic Cue to Particular vs.Generic Reference

Science.gov (United States)

Meyer, Meredith; Baldwin, Dare A.

2013-01-01

Generic noun phrases, or generics, refer to abstract kind categories ("Dogs" bark) rather than particular individuals ("Those dogs" bark). How do children distinguish these distinct kinds of reference? We examined the role of one socio-pragmatic cue, namely pointing, in producing and comprehending generic versus particular…

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

Science.gov (United States)

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

Method for developing cost estimates for generic regulatory requirements

International Nuclear Information System (INIS)

1985-01-01

The NRC has established a practice of performing regulatory analyses, reflecting costs as well as benefits, of proposed new or revised generic requirements. A method had been developed to assist the NRC in preparing the types of cost estimates required for this purpose and for assigning priorities in the resolution of generic safety issues. The cost of a generic requirement is defined as the net present value of total lifetime cost incurred by the public, industry, and government in implementing the requirement for all affected plants. The method described here is for commercial light-water-reactor power plants. Estimating the cost for a generic requirement involves several steps: (1) identifying the activities that must be carried out to fully implement the requirement, (2) defining the work packages associated with the major activities, (3) identifying the individual elements of cost for each work package, (4) estimating the magnitude of each cost element, (5) aggregating individual plant costs over the plant lifetime, and (6) aggregating all plant costs and generic costs to produce a total, national, present value of lifetime cost for the requirement. The method developed addresses all six steps. In this paper, we discuss on the first three

Development of Multi-physics (Multiphase CFD + MCNP) simulation for generic solution vessel power calculation

Energy Technology Data Exchange (ETDEWEB)

Kim, Seung Jun [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Buechler, Cynthia Eileen [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

2017-07-17

The current study aims to predict the steady state power of a generic solution vessel and to develop a corresponding heat transfer coefficient correlation for a Moly99 production facility by conducting a fully coupled multi-physics simulation. A prediction of steady state power for the current application is inherently interconnected between thermal hydraulic characteristics (i.e. Multiphase computational fluid dynamics solved by ANSYS-Fluent 17.2) and the corresponding neutronic behavior (i.e. particle transport solved by MCNP6.2) in the solution vessel. Thus, the development of a coupling methodology is vital to understand the system behavior at a variety of system design and postulated operating scenarios. In this study, we report on the k-effective (keff) calculation for the baseline solution vessel configuration with a selected solution concentration using MCNP K-code modeling. The associated correlation of thermal properties (e.g. density, viscosity, thermal conductivity, specific heat) at the selected solution concentration are developed based on existing experimental measurements in the open literature. The numerical coupling methodology between multiphase CFD and MCNP is successfully demonstrated, and the detailed coupling procedure is documented. In addition, improved coupling methods capturing realistic physics in the solution vessel thermal-neutronic dynamics are proposed and tested further (i.e. dynamic height adjustment, mull-cell approach). As a key outcome of the current study, a multi-physics coupling methodology between MCFD and MCNP is demonstrated and tested for four different operating conditions. Those different operating conditions are determined based on the neutron source strength at a fixed geometry condition. The steady state powers for the generic solution vessel at various operating conditions are reported, and a generalized correlation of the heat transfer coefficient for the current application is discussed. The assessment of multi

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

Science.gov (United States)

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

2010-08-01

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

Patients' concern about their medicine after a generic switch

DEFF Research Database (Denmark)

Østergaard Rathe, Jette; Søndergaard, Jens; Jarbøl, Dorte E

2014-01-01

PURPOSE: This study aims to investigate the possible association between patients' concerns about their medicine and generic switch. METHODS: Cross-sectional survey was carried out comprising responses from 2217 randomly selected persons aged 20 years or older and living in the Region of Southern...... Denmark, who had redeemed generically substitutable drugs in September 2008. For each patient, we focused on the purchase of one generically substitutable drug (index drug). We applied the specific concerns subscale from the Beliefs about Medicine Questionnaire (BMQ) to analyse lack of confidence....... RESULTS: No statistically significant associations were found between concerns about the index medicine and the generic switch (-0.02 95% CI: -0.10; 0.05). Viewing medicines as harmful in general was associated with increased concerns (BMQ general harm: 0.39 95% CI: 0.30; 0.47 and BMQ general overuse: 0...

Generic Drugs: Questions and Answers

Science.gov (United States)

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Resources for You Information for Consumers (Drugs) Questions & Answers Generic Drugs: Questions & Answers Share Tweet Linkedin Pin it More ...

Comparing CO2 Storage and Advection Conditions at Night at Different Carboeuroflux Sites

Science.gov (United States)

Aubinet, M.; Berbigier, P.; Bernhofer, Ch.; et al.

Anemometer and CO2 concentration data from temporary campaigns performed at six CARBOEUROFLUX forest sites were used to estimate the importance of non-turbulent fluxes in nighttime conditions. While storage was observed to be significant only during periods of both low turbulence and low advection, the advective fluxes strongly influence the nocturnal CO2 balance, with the exception of almost flat and highly homogeneous sites. On the basis of the main factors determining the onset of advective fluxes, the ‘advection velocity’, which takes net radiation and local topography into account, was introduced as a criterion to characterise the conditions of storage enrichment/depletion. Comparative analyses of the six sites showed several common features of the advective fluxes but also some substantial differences. In particular, all sites where advection occurs show the onset of a boundary layer characterised by a downslope flow, negative vertical velocities and negative vertical CO2 concentration gradients during nighttime. As a consequence, vertical advection was observed to be positive at all sites, which corresponds to a removal of CO2 from the ecosystem. The main differences between sites are the distance from the ridge, which influences the boundary-layer depth, and the sign of the mean horizontal CO2 concentration gradients, which is probably determined by the source/sink distribution. As a consequence, both positive and negative horizontal advective fluxes (corresponding respectively to CO2 removal from the ecosystem and to CO2 supply to the ecosystem) were observed. Conclusive results on the importance of non-turbulent components in the mass balance require, however, further experimental investigations at sites with different topographies, slopes, different land covers, which would allow a more comprehensive analysis of the processes underlying the occurrence of advective fluxes. The quantification of these processes would help to better quantify nocturnal

A Domain-Specific Language for Generic Interlocking Models and Their Properties

DEFF Research Database (Denmark)

Vu, Linh Hong; Haxthausen, Anne Elisabeth; Peleska, Jan

2017-01-01

of this work is to provide a domain-specific language for generic models and an instantiator tool taking not only configuration data but also a generic model as input instead of using a hard-coded generator for instantiating only one fixed generic model and its properties with configuration data....

Bioequivalence and in vitro antimicrobial activity between generic and brand-name levofloxacin.

Science.gov (United States)

Sun, Hsin-Yun; Liao, Hsiao-Wei; Sheng, Meng-Huei; Tai, Hui-Min; Kuo, Ching-Hua; Sheng, Wang-Huei

2016-07-01

Generic agents play a crucial role in reducing the cost of medical care in many countries. However, the therapeutic equivalence remains a great concern. Our study aims to assess the in vitro antimicrobial activity and bioequivalence between generic and brand-name levofloxacin. Enantiomeric purity test, dissolution test, and in vitro antimicrobial susceptibility against seven clinically important pathogens by the agar dilution method were employed to assess the similarity between four generic products and brand-name levofloxacin (Daiichi Sankyo). All the generic and brand-name levofloxacin passed enantiomeric purity test. The results of dissolution tests were not similar among the generic products and the brand-name levofloxacin. Compared with the generic products, the brand-name levofloxacin had the smallest mean variations (-25% to 13%) with reference standard (United States Pharmacopeia levofloxacin Reference Standards). Variations were observed particularly in dissolution profiles and in vitro activity between generic products and brand-name levofloxacin. Copyright © 2016 Elsevier Inc. All rights reserved.

Increased Topical Generic Prices by Manufacturers: An Isolated Trend or Worrisome Future?

Science.gov (United States)

Bhatt, Mehul D; Bhatt, Birju D; Dorrian, James T; McLellan, Beth N

2018-03-12

There is limited data regarding generic medication prices. Recent studies have shown price changes at the retail level, but much is not known about the pharmaceutical supply chain or price changes at the manufacturer level. We sought to examine the extent of price changes for topical generic medications. A comprehensive review of average wholesale prices (AWP) and manufacturers of topical generics and available corresponding branded medications was conducted for 2005 and 2016. A total of 51 topical chemical entities were examined. Between 2005 and 2016, the AWP of topical generics increased by 273% and the AWP of topical branded increased by 379%. The topical generic with the most price change increased by 2529%. Eight of the top twenty topical generics with the highest increase in AWP also had an increase in the number of manufacturers. These findings are not generalizable to medications used in other areas of medicine CONCLUSIONS: Topical generic prices are rapidly increasing at the manufacturer level. Copyright © 2018. Published by Elsevier Inc.

Generic policy in Bulgaria: a policy of failure or success?

Directory of Open Access Journals (Sweden)

Assena Stoimenova

2016-09-01

Full Text Available Generic medicines play a key role in managing the financial resources for pharmaceuticals in every country. This study analysed the generic policy legislative framework in Bulgaria with the aim to identify whether the policy implementation can be considered successful in the light of an international review of such policies introduced in other countries, or on the contrary, it has failed to deliver the main benefits. Legislative analysis, desktop study and macroeconomic overview of the Bulgarian pharmaceutical market were included. The study showed that only 3 out of 11 important policy elements are implemented in the country. Bulgaria has one of the highest shares of generics, an average of 81.39% (volume, for the studied period (2006–2014. However, further research is needed to evaluate the success of the existing generic policy in Bulgaria, as the market share of generic drugs is not the only measure of the policy efficiency.

The Impact of Information on Doctors’ Attitudes Toward Generic Drugs

Directory of Open Access Journals (Sweden)

Aggeliki V. Tsaprantzi MD

2016-03-01

Full Text Available The objective of this study is to assess the impact of information on doctors’ attitudes and perceptions toward generics. A cross-sectional survey based on a specially designed 21-item questionnaire was conducted. The survey involved doctors of different specialties working in a public hospital in Greece. The analysis includes descriptive and inferential statistics, reliability and validity tests, as well as structural equation modeling to evaluate the causal model. Statistical analysis was accomplished by using SPSS 20 and Amos 20. A total of 134 questionnaires out of 162 were received, providing a response rate of 82.71%. A number of significant associations were found between information and perceptions about generic medicines with demographic characteristics. It seems that the provision of quality information on generic drugs influences doctors’ attitudes and prescription practices toward generic drugs. This is not a static process but a rather dynamic issue involving information provision policies for strengthening the proper doctors’ attitudes toward generic drugs.

Guide for generic application of Reliability Centered Maintenance (RCM) recommendations

International Nuclear Information System (INIS)

Schwan, C.A.; Toomey, G.E.; Morgan, T.A.; Darling, S.S.

1991-02-01

Previously completed reliability centered maintenance (RCM) studies form the basis for developing or refining a preventive maintenance program. This report describes a generic methodology that will help utilities optimize nuclear plant maintenance programs using RCM techniques. This guide addresses the following areas: history of the generic methodology development process, and use of the generic methodology for conducting system-to-system and component-to-component evaluations. 2 refs., 2 figs., 5 tabs

When Does an Argument Use a Generic Example?

Science.gov (United States)

Yopp, David A.; Ely, Rob

2016-01-01

We offer criteria that an observer can use to determine whether an argument that uses an example to argue for a general claim appeals to that example generically. We review existing literature on generic example and note the strengths of each contribution, as well as inconsistencies among uses of the term. We offer several examples from the…

The SENSEI Generic In Situ Interface

Energy Technology Data Exchange (ETDEWEB)

Ayachit, Utkarsh [Kitware, Inc., Clifton Park, NY (United States); Whitlock, Brad [Intelligent Light, Rutherford, NJ (United States); Wolf, Matthew [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Loring, Burlen [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Geveci, Berk [Kitware, Inc., Clifton Park, NY (United States); Lonie, David [Kitware, Inc., Clifton Park, NY (United States); Bethel, E. Wes [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

2017-04-11

The SENSEI generic in situ interface is an API that promotes code portability and reusability. From the simulation view, a developer can instrument their code with the SENSEI API and then make make use of any number of in situ infrastructures. From the method view, a developer can write an in situ method using the SENSEI API, then expect it to run in any number of in situ infrastructures, or be invoked directly from a simulation code, with little or no modification. This paper presents the design principles underlying the SENSEI generic interface, along with some simplified coding examples.

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

Science.gov (United States)

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.

40 CFR 721.10146 - Partially fluorinated condensation polymer (generic).

Science.gov (United States)

2010-07-01

... polymer (generic). 721.10146 Section 721.10146 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10146 Partially fluorinated condensation polymer (generic). (a) Chemical... as partially fluorinated condensation polymer (PMN P-07-87) is subject to reporting under this...

Applicability of generic assays based on liquid chromatography–electrospray mass spectrometry to study in vitro metabolism of 55 structurally diverse compounds

Directory of Open Access Journals (Sweden)

Timo Rousu

2010-08-01

Full Text Available Liquid chromatography-mass spectrometry (LC/MS with generic gradient elution for a large number of chemically different compounds is a common approach in drug development, used to acquire a large amount of data in a short time frame for drug candidates. The analysis with non-optimised parameters however may lead to a poor method performance for many compounds, and contains a risk of losing important information. Here, generic electrospray-time-of-flight (ESI-TOF MS methods in various pH conditions were tested for 55 chemically diverse compounds (10 acids, 25 bases, 17 neutrals and 3 amphoterics, aiming to find best analytical conditions for each compound, for studies of in vitro metabolic properties in liver preparations. The effect of eluent pH and elution gradient strength on chromatographic performance and electrospray MS ionisation efficiency were examined for each compound. The data are evaluated how well the best generic approach could cover the analysis of test compounds and how many compounds would still need completely different analytical conditions after that. Aqueous mobile phase consisting of 0.05% acetic acid and 5 mM ammonium acetate (pH 4.4 showed the best general suitability for the analyses, showing adequate performance for metabolite profiling for 41 out of 55 compounds either in positive or negative ion mode. In positive ion mode, the main limitation of performance in various pH conditions was generally not the lack of ionisation, but rather the poor chromatographic performance (inadequate retention or poor peak shape, suggesting that more emphasis should be put in finding conditions providing best chromatographic performance, rather than highest ionisation properties. However, a single generic approach for a large number of different compounds is not likely to produce good results for all compounds. Preferably, at least two or three different conditions are needed for the coverage of a larger number of structurally diverse

Explaining parent-child (dis)agreement in generic and short stature-specific health-related quality of life reports: do family and social relationships matter?

Science.gov (United States)

Quitmann, Julia; Rohenkohl, Anja; Sommer, Rachel; Bullinger, Monika; Silva, Neuza

2016-10-21

In the context of health-related quality of life (HrQoL) assessment in pediatric short stature, the present study aimed to examine the levels of agreement/disagreement between parents' and children's reports of generic and condition-specific HrQoL, and to identify socio-demographic, clinical and psychosocial variables associated with the extent and direction of parent-child discrepancies. This study was part of the retest phase of the QoLISSY project, which was a multicenter study conducted simultaneously in France, Germany, Spain, Sweden and UK. The sample comprised 137 dyads of children/adolescents between 8 and 18 years of age, diagnosed with growth hormone deficiency (GHD) or idiopathic short stature (ISS), and one of their parents. The participants completed child- and parent-reported questionnaires on generic (KIDSCREEN-10 Index) and condition-specific HrQoL (QoLISSY Core Module). Children/adolescents also reported on social support (Oslo 3-items Social Support Scale) and parents assessed the parent-child relationships (Parental Role subscale of the Social Adjustment Scale) and burden of short stature on parents (QoLISSY- additional module). The parent-child agreement on reported HrQoL was strong (intraclass correlation coefficients between .59 and .80). The rates of parent-child discrepancies were 61.5 % for generic and 35.2 % for condition-specific HrQoL, with the parents being more prone to report lower generic (42.3 %) and condition-specific HrQoL (23.7 %) than their children. The extent of discrepancies was better explained by family and social relationships than by clinical and socio-demographic variables: poorer parent-child relationships and better children's social support were associated with larger discrepancies in generic HrQoL, while more parental burden was associated with larger discrepancies in condition-specific HrQoL reports. Regarding the direction of discrepancies, higher parental burden was significantly associated with parents

40 CFR 721.10151 - Modified styrene, divinylbenzene polymer (generic).

Science.gov (United States)

2010-07-01

... polymer (generic). 721.10151 Section 721.10151 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10151 Modified styrene, divinylbenzene polymer (generic). (a) Chemical... as modified styrene, divinylbenzene polymer (PMN P-07-642) is subject to reporting under this section...

Generic task problem descriptions: Category B, C, and D tasks

International Nuclear Information System (INIS)

1978-06-01

This document contains information relating to Category B, C, and D generic technical activities. The specific information provided for each task includes the reactor type to which the generic issue applies, the NRC division with lead responsibility and a description of the problem to be addressed by the task. Also provided in this document is a listing of Category A generic technical activities and definitions of Priority Categories A, B, C, and D

Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city.

Science.gov (United States)

Guttier, Marília Cruz; Silveira, Marysabel Pinto Telis; Luiza, Vera Lucia; Bertoldi, Andréa Dâmaso

2017-06-26

The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old). The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. The preference for purchasing generic drugs was 63.2% (95%CI 61.4-64.9). The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03-1.14), age of 20-39 years (PR = 1.10; 95%CI 1.02-1.20), low socioeconomic status (PR = 1.15; 95%CI 1.03-1.28), and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89-7.52). Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic) with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93-2.41). Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil.

Conversion of agonist site to metal-ion chelator site in the beta(2)-adrenergic receptor

DEFF Research Database (Denmark)

Elling, C E; Thirstrup, K; Holst, Birgitte

1999-01-01

Previously metal-ion sites have been used as structural and functional probes in seven transmembrane receptors (7TM), but as yet all the engineered sites have been inactivating. Based on presumed agonist interaction points in transmembrane III (TM-III) and -VII of the beta(2)-adrenergic receptor,...... as generic, pharmacologic tools to switch 7TM receptors with engineered metal-ion sites on or off at will.......Previously metal-ion sites have been used as structural and functional probes in seven transmembrane receptors (7TM), but as yet all the engineered sites have been inactivating. Based on presumed agonist interaction points in transmembrane III (TM-III) and -VII of the beta(2)-adrenergic receptor......, in this paper we construct an activating metal-ion site between the amine-binding Asp-113 in TM-III-or a His residue introduced at this position-and a Cys residue substituted for Asn-312 in TM-VII. No increase in constitutive activity was observed in the mutant receptors. Signal transduction was activated...

Analysis of Knowledge Level and Perception on Singkawang City Community towards Generic Medicines

Directory of Open Access Journals (Sweden)

Forid Morison

2015-03-01

Full Text Available Survey data show that the use of generic medicines in Indonesia is relatively very small, which only amounted 7%. This is due to lack of knowledge and poor perceptions towards generic medicines. Knowledge level and perceptions towards generic medicines are inflenced by community characteristics and information resource regarding generic medicines. The aim of this study was to determine the association between community characteristic and information resources with knowledge level and perception towards generic medicines. This study was an analytical survey with cross-sectional descriptive approach on 142 selected respondents who were fulfi inclusion and exclusion criteria. This study was conducted in June 2014 at several randomly selected locations on Singkawang City. The study show that 76 respondents (53.5% had inadequate knowledge and 123 respondents (86.6% had a good perception towards generic medicines. There is signifiant relationship between ethnicity (p=0.000 and information resources (p=0.009 with knowledge level regarding generic medicines at signifiance level of p<0.05. Although good perceptions were noted among the respondents, widespread dissemination of information regarding generic medicines should be continued to increase generic medicines used.

Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada.

Science.gov (United States)

Kuribayashi, Ryosuke; Appleton, Scott

2017-09-01

Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. The objective of this study was to examine generic drug reviews in Japan and Canada. We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms. This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities. The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada.

Assessment of technologies for the remediation of radioactively contaminated Superfund sites

International Nuclear Information System (INIS)

1990-01-01

The report is a screening evaluation of information needs for the development of generic treatability studies for the remediation of Superfund Radiation Sites on the National Priorities List (NPL). It presents a categorization of the 25 radiation sites currently proposed or listed on the NPL, and provides a rating system for evaluating technologies that may be used to remediate these sites. It also identifies gaps in site assessment and technology data and provides information about and recommendations for technology development

Avoidance of generic competition by Abbott Laboratories' fenofibrate franchise.

Science.gov (United States)

Downing, Nicholas S; Ross, Joseph S; Jackevicius, Cynthia A; Krumholz, Harlan M

2012-05-14

The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug's history: Abbott Laboratories, the maker of branded fenofibrate, has produced several bioequivalent reformulations that dominate the market, although generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on the US health care system. Abbott Laboratories maintained its dominance of the fenofibrate market in part through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first-generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented their substitution with generics of older-generation products. As soon as direct generic competition seemed likely at the new dose level, where substitution would be allowed, Abbott would launch another reformulation, and the cycle would repeat. Based on the fenofibrate example, our objective is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications, without demonstrating the superiority of next-generation products.

Generic legislation of new psychoactive drugs.

Science.gov (United States)

van Amsterdam, Jan; Nutt, David; van den Brink, Wim

2013-03-01

New psychoactive drugs (NPDs, new psychoactive substances) enter the market all the time. However, it takes several months to ban these NPDs and immediate action is generally not possible. Several European countries and drug enforcement officers insist on a faster procedure to ban NPDs. Introduction of generic legislation, in which clusters of psychotropic drugs are banned in advance, has been mentioned as a possible solution. Here we discuss the pros and cons of such an approach. First, generic legislation could unintentionally increase the expenditures of enforcement, black market practices, administrative burden and health risks for users. Second, it may have a negative impact on research and the development of new treatments. Third, due to the complexity of generic legislation, problems in the enforcement are anticipated due to lack of knowledge about the chemical nomenclature. Finally, various legal options are already available to ban the use, sale and trade of NPDs. We therefore conclude that the currently used scientific benefit-risk evaluation should be continued to limit the adverse health effects of NPDs. Only in emergency cases, where fatal incidents (may) occur, should this approach be overruled.

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

Science.gov (United States)

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

2017-09-01

Policy Points: Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. Rising drug prices are putting pressure on health care budgets. Policymakers are assessing how they can save money through generic drugs. We compared generic drug prices and market shares in 13 European countries, using data from 2013, to assess the amount of variation that exists between countries. To place these results in context, we reviewed evidence from recent studies on the prices and use of generics in Europe and the United States. We also surveyed peer-reviewed studies, gray literature, and books published since 2000 to (1) outline existing generic drug policies in European countries and the United States; (2) identify ways to increase generic drug use and to promote price competition among generic drug companies; and (3) explore barriers to implementing reform of generic drug policies, using a historical example from the United States as a case study. The prices and market shares of generics vary widely across Europe. For example, prices charged by manufacturers in Switzerland are, on average, more than 2.5 times those in Germany and more than 6 times those in the United Kingdom, based on the results of a commonly used price index. The proportion of prescriptions filled with generics ranges from 17% in Switzerland to 83% in the United Kingdom. By comparison, the United States has historically had low generic drug prices and high rates of generic drug use (84% in 2013), but has in recent years experienced sharp price increases for some off-patent products. There are policy

Endogenous versus exogenous generic reference pricing for pharmaceuticals.

Science.gov (United States)

Antoñanzas, F; Juárez-Castelló, C A; Rodríguez-Ibeas, R

2017-12-01

In this paper we carry out a vertical differentiation duopoly model applied to pharmaceutical markets to analyze how endogenous and exogenous generic reference pricing influence competition between generic and branded drugs producers. Unlike the literature, we characterize for the exogenous case the equilibrium prices for all feasible relevant reference prices. Competition is enhanced after the introduction of a reference pricing system. We also compare both reference pricing systems on welfare grounds, assuming two different objective functions for health authorities: (i) standard social welfare and (ii) gross consumer surplus net of total pharmaceutical expenditures. We show that regardless of the objective function, health authorities will never choose endogenous reference pricing. When health authorities are paternalistic, the exogenous reference price that maximizes standard social welfare is such that the price of the generic drug is the reference price while the price of the branded drug is higher than the reference price. When health authorities are not paternalistic, the optimal exogenous reference price is such that the price of the branded drug is the reference price while the price of the generic drug is lower than the reference price.

Development of a generic virus behavioural detector: a preview ...

African Journals Online (AJOL)

The Generic Virus Behavioral Detector (GVBD) is a system (program) that monitors various system activities; reading and writing block of disks and memory and the use of Interrupts. A technique for its realisation is presented. Key Words: Computer virus, interrupts, handlers, GVBD (Generic Virus Behavioral Detector).

Instrumentation for comparing night sky quality and atmospheric conditions of CTA site candidates

International Nuclear Information System (INIS)

Fruck, C.; Schweizer, T.; Häfner, D.; Lorentz, E.; Teshima, M.; Gaug, M.; Ernenwein, J.-P.; Costantini, H.; Mandát, D.; Pech, M.; Bulik, T.; Cieslar, M.; Dominik, M.; Ebr, J.; Garczarczyk, M.; Pareschi, G.; Puerto-Giménez, I.

2015-01-01

Many atmospheric and climatic criteria have to be taken into account for the selection of a suitable site for the next generation of imaging air-shower Cherenkov telescopes, the ''Cherenkov Telescope Array'' CTA. Such data are not available with sufficient precision, thus a comparison of the proposed sites and final decision based on a comprehensive characterization is impossible. Identical cross-calibrated instruments have been developed which allow for precise comparison between sites, the cross-validation of existing data, and the ground-validation of satellite data. The site characterization work package of the CTA consortium opted to construct and deploy 9 copies of an autonomous multi-purpose weather sensor, incorporating an infrared cloud sensor, a newly developed sensor for measuring the light of the night sky, and an All-Sky-Camera, the whole referred to as Autonomous Tool for Measuring Observatory Site COnditions PrEcisely (ATMOSCOPE). We present here the hardware that was combined into the ATMOSCOPE and characterize its performance

Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city

Directory of Open Access Journals (Sweden)

Marília Cruz Guttier

Full Text Available ABSTRACT OBJECTIVE The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. METHODS We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old. The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. RESULTS The preference for purchasing generic drugs was 63.2% (95%CI 61.4–64.9. The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03–1.14, age of 20–39 years (PR = 1.10; 95%CI 1.02–1.20, low socioeconomic status (PR = 1.15; 95%CI 1.03–1.28, and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89–7.52. Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93–2.41. CONCLUSIONS Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil.

40 CFR 721.10017 - Amine terminated bisphenol A diglycidyl ether polymer (generic).

Science.gov (United States)

2010-07-01

... diglycidyl ether polymer (generic). 721.10017 Section 721.10017 Protection of Environment ENVIRONMENTAL... ether polymer (generic). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as amine terminated bisphenol A diglycidyl ether polymer (PMNs P...

GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

OpenAIRE

Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

2017-01-01

Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

Generic information can retrieve known biological associations: implications for biomedical knowledge discovery.

Directory of Open Access Journals (Sweden)

Herman H H B M van Haagen

Full Text Available MOTIVATION: Weighted semantic networks built from text-mined literature can be used to retrieve known protein-protein or gene-disease associations, and have been shown to anticipate associations years before they are explicitly stated in the literature. Our text-mining system recognizes over 640,000 biomedical concepts: some are specific (i.e., names of genes or proteins others generic (e.g., 'Homo sapiens'. Generic concepts may play important roles in automated information retrieval, extraction, and inference but may also result in concept overload and confound retrieval and reasoning with low-relevance or even spurious links. Here, we attempted to optimize the retrieval performance for protein-protein interactions (PPI by filtering generic concepts (node filtering or links to generic concepts (edge filtering from a weighted semantic network. First, we defined metrics based on network properties that quantify the specificity of concepts. Then using these metrics, we systematically filtered generic information from the network while monitoring retrieval performance of known protein-protein interactions. We also systematically filtered specific information from the network (inverse filtering, and assessed the retrieval performance of networks composed of generic information alone. RESULTS: Filtering generic or specific information induced a two-phase response in retrieval performance: initially the effects of filtering were minimal but beyond a critical threshold network performance suddenly drops. Contrary to expectations, networks composed exclusively of generic information demonstrated retrieval performance comparable to unfiltered networks that also contain specific concepts. Furthermore, an analysis using individual generic concepts demonstrated that they can effectively support the retrieval of known protein-protein interactions. For instance the concept "binding" is indicative for PPI retrieval and the concept "mutation abnormality" is

Does the market share of generic medicines influence the price level?: a European analysis.

Science.gov (United States)

Dylst, Pieter; Simoens, Steven

2011-10-01

After the expiry of patents for originator medicines, generic medicines can enter the market, and price competition may occur. This process generates savings to the healthcare payer and to patients, but knowledge about the factors affecting price competition in the pharmaceutical market following patent expiry is still limited. This study aimed to investigate the relationship between the market share of generic medicines and the change of the medicine price level in European off-patent markets. Data on medicine volumes and values for 35 active substances were purchased from IMS Health. Ex-manufacturer prices were used, and the analysis was limited to medicines in immediate-release, oral, solid dosage forms. Countries included were Austria, Belgium, Denmark, Germany, France, Italy, the Netherlands, Spain, Sweden and the UK, which constitute a mix of countries with low and high generic medicines market shares. Data were available from June 2002 until March 2007. Market volume has risen in both high and low generic market share countries (+29.27% and +27.40%, respectively), but the cause of the rise is different for the two markets. In low generic market share countries, the rise was caused by the increased use of generic medicines, while in high market share countries, the rise was driven by the increased use of generic medicines and a shift of use from originator to generic medicines. Market value was substantially decreased in high generic market share countries (-26.6%), while the decrease in low generic market share countries was limited (-0.06%). In high generic market share countries, medicine prices dropped by -43.18% versus -21.56% in low market share countries. The extent to which price competition from generic medicines leads to price reductions appears to vary according to the market share of generic medicines. High generic market share countries have seen a larger decrease in medicine prices than low market share countries.

Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis.

Science.gov (United States)

Vial, Jérôme; Cohen, Mélanie; Sassiat, Patrick; Thiébaut, Didier

2008-07-01

The aim of this study was to evaluate the quality of 31 commercially available generic formulations of docetaxel purchased in 14 countries by comparing their docetaxel content, impurity levels and pH versus those of the proprietary product Taxotere (Tx). Generic formulations were purchased in 14 countries in Asia, Africa, the Middle East and Latin America. Levels of docetaxel and impurities (chromatographic peaks above 0.05%) were obtained for each sample using reverse-phase liquid chromatography with ultraviolet detection. The pH of aqueous solutions of generic docetaxel formulations and Tx was also measured. A global evaluation of quality was conducted on each product using a multicriteria desirability analysis based on standards defined by the International Conference on Harmonisation guidelines and the US Pharmacopeia paclitaxel injection monograph. Most generic formulations contained a lower than expected amount of docetaxel and/or a high level of impurities: 21 generic docetaxel formulations had an average mass of docetaxel that was generic docetaxel formulations had a total impurity content of >3.0%, almost twice the level of impurities in Tx 20 mg. In total, 33 impurities not present in Tx were detected in the generic samples. Desirability analysis demonstrated that none of the generic docetaxel formulations had composition characteristics similar to those of Tx. This study demonstrated that from an analytical point of view, 90% of the generic docetaxel formulations evaluated contained insufficient active drug, high levels of impurities or both. This has the potential to affect both efficacy and safety of the drug.

Cisplatin-induced hyponatremia in malignancy: comparison between brand-name and generic formulation.

Science.gov (United States)

Ochi, Nobuaki; Yamane, Hiromichi; Hotta, Katsuyuki; Fujii, Hiromi; Isozaki, Hideko; Honda, Yoshihiro; Yamagishi, Tomoko; Kubo, Toshio; Tanimoto, Mitsune; Kiura, Katsuyuki; Takigawa, Nagio

2014-01-01

Widespread use of generic drugs is considered to be indispensable if reductions in total health care costs are to be achieved, but the market share of such drugs remains low. In general, generic drugs have the same active ingredients as brand-name drugs, but this is not always the case. Thus, toxicity profiles may vary when brand-name and generic drugs are compared. We retrospectively investigated the incidence of hyponatremia in patients receiving brand-name cisplatin (CDDP) and a generic counterpart thereof. We reviewed the medical records of patients treated with brand-name CDDP (n=53) and a generic formulation (n=26), and compared the incidences of hyponatremia and renal toxicity. Toxicities were graded using the Common Terminology Criteria for Adverse Events, version 4.0. Differences between groups were evaluated using the Student's t-test, and the odds ratio for hyponatremia was estimated via logistic regression analysis. Serum creatinine levels after chemotherapy increased significantly in both the brand-name and generic CDDP groups; no significant difference was evident between the two groups. Hyponatremia of grade 3 or above developed in 30.7% of the generic CDDP group compared to 15.1% of the brand-name CDDP group (P=0.011). Multivariate analysis showed that the use of generic CDDP increased the incidence of hyponatremia (odds ratio =5.661, 95% confidence interval =1.403-22.839; P=0.015). Oncologists should be aware that use of a generic CDDP might be associated with more hyponatremia than would use of brand-name CDDP.

Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

Directory of Open Access Journals (Sweden)

Garth Boehm

2013-09-01

Full Text Available The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.

Factors influencing anti-asthmatic generic drug consumption in Morocco: 1999-2010.

Science.gov (United States)

Ghanname, Imane; Ahid, Samir; Berrada, Ghizlane; Belaiche, Abdelmjid; Hassar, Mohammed; Cherrah, Yahia

2014-01-01

The increasing availability of generic drugs (GD) resulted in a remarkable reduction in treatment costs that allowed a better access to health care.The aim of this study is to evaluate the share of anti-asthmatic generic drugs during the period 1999-2010 in Morocco and to look at the factors influencing generic development. In this study, we used Moroccan sales data from IMS Health (Intercontinental Marketing Services). The consumption of the drugs was expressed in DDD/1000 inhabitants/day according to the WHO ATC/DDD methodology. Between 1999 and 2010, anti-asthmatic consumption increased from 3.91 to 14.43 DDD/1000 inhabitants/day. The market of anti-asthmatic generic drugs progressed from 1.83 (47%) to 2.18 (23%) DDD/1000 inhabitants/day from 1999 to 2010. In 2010, inhaled glucocorticosteroids ranked first (0.83 DDD/1000 inhabitants/day), followed by inhaled short acting beta agonists (0.73 DDD/1000 inhabitants/day). The number of brands went from 27 in 1999 to 34 in 2010, with a generic share increasing from 55.55% to 70.59%. The number of anti-asthmatic pharmaceutical preparations increased from 57 to 64 during the same period, of which 31 and 42 were generic preparations. In 2010, the total cost of anti-asthmatic dugs was about 22 million euro, the generics representing 14 million euro. Despite the introduction of a compulsory insurance scheme called "AMO", that allows a refund for 69.5% of anti-asthmatic specialties marketed in Morocco, anti-asthmatic generic drug consumption remains limited. The Moroccan market is still largely dominated by the originator drugs with still valid patents.

Recharge and Lateral Groundwater Flow Boundary Conditions for the Saturated Zone Site-Scale Flow and Transport Model

Energy Technology Data Exchange (ETDEWEB)

B. Arnold; T. Corbet

2001-12-18

The purpose of the flow boundary conditions analysis is to provide specified-flux boundary conditions for the saturated zone (SZ) site-scale flow and transport model. This analysis is designed to use existing modeling and analysis results as the basis for estimated groundwater flow rates into the SZ site-scale model domain, both as recharge at the upper (water table) boundary and as underflow at the lateral boundaries. The objective is to provide consistency at the boundaries between the SZ site-scale flow model and other groundwater flow models. The scope of this analysis includes extraction of the volumetric groundwater flow rates simulated by the SZ regional-scale flow model to occur at the lateral boundaries of the SZ site-scale flow model and the internal qualification of the regional-scale model for use in this analysis model report (AMR). In addition, the scope includes compilation of information on the recharge boundary condition taken from three sources: (1) distributed recharge as taken from the SZ regional-scale flow model, (2) recharge below the area of the unsaturated zone (UZ) site-scale flow model, and (3) focused recharge along the Fortymile Wash channel.

Growth of blue mussels in a Norwegian and French culture site: comparison of food proxies with Dynamic Energy Budgets (DEB)

OpenAIRE

Alunno-bruscia, Marianne; Rosland, Rune; Strand, Øivind; Naustvoll, Lars; Robert, Stephane; Bacher, Cedric

2010-01-01

Introduction The blue mussel (Mytilus edulis) culture occurs in temperate waters around the world under a wide range of environmental conditions, e.g. at phytoplankton concentrations below as 1-2 µg L-1 (in Norwegian fjords) up to 9-10 µg L-1 (in French Atlantic coastal sites). Under such contrasted food resources, the aim of our study is to develop a generic bio-energetic model for M. edulis, i.e. that can be applied in various contrasted environments with a constant set of parameters, to...

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

Science.gov (United States)

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

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

International Thermonuclear Experimental Reactor (ITER) plant layout and site services

International Nuclear Information System (INIS)

Chuyanov, V.

2001-01-01

The ITER site has not been determined at this time. Nevertheless, to develop a construction plan and a cost estimate, it is necessary to have a detailed layout of the buildings, structures, and outdoor equipment integrated with the balance of plant service systems prototypical of large fusion power plants. These services include electric power for magnet feeds and plasma heating systems, cryogenic and conventional cooling systems, compressed air, gas supplies, de-mineralized water, steam, and drainage. Nuclear grade facilities are provided to handle tritium fuel and activated waste, as well as to prevent radioactive exposure of either the workers or the public. To avoid interference between services of different types and for efficient arrangement of buildings, structures, and equipment within the site area, a plan was developed which segregated different classes of services to four quadrants surrounding the tokamak building, placed at the approximate geographic center of the site. Location of the twenty-seven buildings on the generic site was selected to meet all design requirements at minimum total project cost. A similar approach has been used to determine the location of services above, at, and below grade. The generic site plan can be adapted to the site selected for ITER without significant changes to the buildings or equipment. Some rearrangements may be required by site topography resulting primarily in changes to the length of services that link the buildings and equipment. (author)

International Thermonuclear Experimental Reactor (ITER) plant layout and site services

International Nuclear Information System (INIS)

Chuyanov, V.

1999-01-01

The ITER site has not been determined at this time. Nevertheless, to develop a construction plan and a cost estimate, it is necessary to have a detailed layout of the buildings, structures, and outdoor equipment integrated with the balance of plant service systems prototypical of large fusion power plants. These services include electric power for magnet feeds and plasma heating systems, cryogenic and conventional cooling systems, compressed air, gas supplies, de-mineralized water, steam, and drainage. Nuclear grade facilities are provided to handle tritium fuel and activated waste, as well as to prevent radioactive exposure of either the workers or the public. To avoid interference between services of different types and for efficient arrangement of buildings, structures, and equipment within the site area, a plan was developed which segregated different classes of services to four quadrants surrounding the tokamak building, placed at the approximate geographic center of the site. Location of the twenty-seven buildings on the generic site was selected to meet all design requirements at minimum total project cost. A similar approach has been used to determine the location of services above, at, and below grade. The generic site plan can be adapted to the site selected for ITER without significant changes to the buildings or equipment. Some rearrangements may be required by site topography resulting primarily in changes to the length of services that link the buildings and equipment. (author)

Shippingport Station Decommissioning Project site release protocol

International Nuclear Information System (INIS)

Handy, J.W.

1988-01-01

The Richland, Washington field office of the DOE and its Remedial Actions Contractor, GE, took possession of the SSDP site in September 1984. In February of the following year, DOE-HQ issued generic, site independent guidelines taken from existing radiation protection standards. Basic generic dose limits were English equivalents of 1 mSv (100 mrem) per year averaged over the lifetime of any individual member of the general public. Hot spot limits were given. Occupied or habitable structures were limited to 5.2 x 10 -9 C/Kg h (20mR/h). Surface contamination was limited to standards plus average and maximum contact dose rates of 2 microGy (0.2 mrad) per hour and 10 microGy (1 mrad) per hour respectively. In addition, ''all exposures ... were to be limited to levels that (were) as low as reasonably achievable (ALARA).'' Authorized limits higher than these guidelines were allowed under given exceptional circumstances. GE determined the allowable radionuclide concentrations that could remain in soil and included rubble, and not dose the resident farmer to more than 1 mSv (100 mrem) per year. Under more conservative scenarios, however, exposures were controlled for buried, potentially occupationally occupiable, concrete substructures, to souvenir items, or to buried, but potentially exposed, concrete slabs. GE incorporated the scenario's pathways into a document implementing specific site release criteria which cannot be exceeded if the site is to be released unconditionally. 3 refs., 1 fig

Comparing effectiveness of generic and disease-specific self-management interventions for people with diabetes in a practice context.

Science.gov (United States)

Ghahari, Setareh; Packer, Tanya; Boldy, Duncan; Melling, Lauren; Parsons, Richard

2015-10-01

The effectiveness of self-management interventions has been demonstrated. However, the benefits of generic vs. disease-specific programs are unclear, and their efficacy within a practice setting has yet to be fully explored. To compare the outcomes of the diabetes-specific self-management program (Diabetes) and the generic chronic disease Self-management Program (Chronic Condition) and to explore whether program characteristics, evaluated using the Quality Self-Management Assessment Framework (Q-SAF), provide insight into the results of the outcome evaluation. A pragmatic pretest, post-test design with 12-week follow up was used to compare the 2 self-management interventions. Outcomes were quality of life, self-efficacy, loneliness, self-management skills, depression, and health behaviours. People with diabetes self-selected attendance at the Diabetes or Chronic Condition program offered as part of routine practice. Participants with diabetes in the 2 programs (Diabetes=200; Chronic Condition=90) differed significantly in almost all demographic and clinical characteristics. Both programs yielded positive outcomes. Controlling for baseline and demographic characteristics, random effects modelling showed an interaction between time and program for 1 outcome: self-efficacy (p=0.029). Participants in the Chronic Condition group experienced greater improvements over time than did those in the Diabetes group. The Q-SAF analysis showed differences in program content, delivery and workforce capacity. People with diabetes benefited from both programs, but participation in the generic program resulted in greater improvements in self-efficacy for participants who had self-selected that program. Both programs in routine care led to health-related improvements. The Q-SAF can be used to assess the quality of programs. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

Socioeconomic conditions and number of pain sites in women

Directory of Open Access Journals (Sweden)

Rannestad Toril

2012-03-01

Full Text Available Abstract Background Women in deprived socioeconomic situations run a high pain risk. Although number of pain sites (NPS is considered highly relevant in pain assessment, little is known regarding the relationship between socioeconomic conditions and NPS. Methods The study population comprised 653 women; 160 recurrence-free long-term gynecological cancer survivors, and 493 women selected at random from the general population. Demographic characteristics and co-morbidity over the past 12 months were assessed. Socioeconomic conditions were measured by Socioeconomic Condition Index (SCI, comprising education, employment status, income, ability to pay bills, self-perceived health, and satisfaction with number of close friends. Main outcome measure NPS was recorded using a body outline diagram indicating where the respondents had experienced pain during the past week. Chi-square test and forward stepwise logistic regression were applied. Results and Conclusion There were only minor differences in SCI scores between women with 0, 1-2 or 3 NPS. Four or more NPS was associated with younger age, higher BMI and low SCI. After adjustment for age, BMI and co-morbidity, we found a strong association between low SCI scores and four or more NPS, indicating that there is a threshold in the NPS count for when socioeconomic determinants are associated to NPS in women.

U.S. NRC's generic issues program

International Nuclear Information System (INIS)

Kauffman, J.V.; Foster, J.W.

2008-01-01

The United States Nuclear Regulatory Commission (NRC) has a Generic Issues Program (GIP) to address Generic Issues (GI). A GI is defined as 'a regulatory matter involving the design, construction, operation, or decommissioning of several, or a class of, NRC licensees or certificate holders that is not sufficiently addressed by existing rules, guidance, or programs'. This rather legalistic definition has several practical corollaries: First, a GI must involve safety. Second, the issue must involve at least two plants, or it would be a plant-specific issue rather than a GI. Third, the potential safety question must not be covered by existing regulations and guidance (compliance). Thus, the effect of a GI is to potentially change the body of regulations and associated guidance (e.g., regulatory guides). The GIP was started in 1976, thus it is a relatively mature program. Approximately 850 issues have been processed by the program to date. More importantly, even after 30 years, new GIs continue to be proposed. The entire set of Generic Issues (GIs) is updated annually in NUREG-0933, 'A Prioritization of Generic Safety Issues'. GIs normally involve complex questions of safety and regulation. Efficient and effective means of addressing these issues are very important for regulatory effectiveness. If an issue proves to pose a genuine, significant safety question, then swift, effective, enforceable, and cost-effective action needs to be taken. Conversely, if an issue is of little safety significance, the issue should be dismissed in an expeditious manner, avoiding unnecessary expenditure of resources and regulatory burden or uncertainty. This paper provides a summary of the 5-stage program, from identification through the regulatory assessment stage. The paper also includes a discussion of the program's seven criteria, sources of proposed GIs, recent improvements, publicly available information, historical performance, and status of current GIs. (authors)

Generic test platform for representative tests of safety I/C systems - 15546

International Nuclear Information System (INIS)

Fourestie, B.; Kuck, H.; Richter, J.; Rieche, S.; Waitz, M.

2015-01-01

In compliance with the IEC 61513 safety Instrumentation and Control (I/C) systems must be successfully validated in their final configuration prior to installation on site and commissioning. However the contingent need for modifications during system validation activities or subsequently during the commissioning phase may entail long and costly re-engineering of the I/C systems. With the view to ease these possible modifications, a Generic Test Platform has been developed by AREVA which allows combining a real I/C system subpart with an emulation server. This platform provides a faithful representation of the I/C System allowing crediting the validation test results carried out on this platform. (authors)

Site specificity of biosphere parameter values in performance assessments of near-surface repositories

International Nuclear Information System (INIS)

Zeevaert, Th.; Volckaert, G.; Vandecasleele

1993-01-01

The contribution is dealing with the performance assessment model for near surface repositories in Belgium. It consists of four submodels called: site, aquifer, biosphere and dose. For some characteristic radionuclides, results of the study are shown for a typical site, and differences in doses assessed with the generic approach discussed. Shortcomings are indicated

IAEA's experience in compiling a generic component reliability data base

International Nuclear Information System (INIS)

Tomic, B.; Lederman, L.

1988-01-01

Reliability data are an essential part of probabilistic safety assessment. The quality of data can determine the quality of the study as a whole. It is obvious that component failure data originated from the plant being analyzed would be most appropriate. However, in few cases complete reliance on plant experience is possible, mainly because of the rather limited operating experience. Nuclear plants, although of different design, often use fairly similar components, so some of the experience could be combined and transferred from one plant to another. In addition information about component failures is available also from experts with knowledge on component design, manufacturing and operation. That bring us to the importance of assessing generic data. (Generic is meant to be everything that is not plant specific regarding the plant being analyzed). The generic data available in the open literature, can be divided in three broad categories. The first one includes data base used in previous analysis. These can be plant specific or updated from generic with plant specific information (latter case deserve special attention). The second one is based on compilation of plants' operating experience usually based on some kind of event reporting system. The third category includes data sources based on expert opinions (single or aggregate) or combination of expert opinions and other nuclear and non-nuclear experience. This paper reflects insights gained in compiling data from generic data sources and highlights advantages and pitfalls of using generic component reliability data in PSAs

[Two cases of pulmonary aspergilosis, which deteriorated with generic itraconazole].

Science.gov (United States)

Saito, Wakana; Shishikura, Yutaka; Nishimaki, Katsushi; Kikuchi, Tadashi; Sasamori, Kan; Kikuchi, Yoshihiro; Miki, Hiroshi

2014-07-01

We experienced two cases of pulmonary aspergillosis, which deteriorated during treatment with generic itraconazole (ITCZ) because of low plasma concentration. One case was chronic pulmonary aspergillosis and the other was allergic bronchopulmonary aspergillosis (ABPA). Treatment of both cases was started with a brand-name-ITCZ, and changed to a generic ITCZ. Deterioration of pulmonary aspergillosis occurred after 8 months and 9 months from change to generic ITCZ respectively. In the first case, the ITCZ-plasma concentration was 46.9 ng/mL and of OH-ITCZ 96.5 ng/mL with generic ITCZ at the dose of 300 mg/day, but increased to 1,559.7 ng/mL and to 2,485.0 ng/mL with the brand-name-ITCZ 300 mg/day, respectively. In the second case, the ITCZ-plasma concentration was 27.2 ng/mL and of OH-ITCZ 20.1 ng/mL with 150 mg/day for generic ITCZ, but reached 857.3 ng/mL and to 1,144.2 ng/ml with the brand-name-ITCZ 300 mg/day, respectively. After treatment failure, the first case was changed to voriconazole, then brand-name-ITCZ 300 mg/day, and the second case to the brand-name-ITCZ 300 mg/day, with successful clinical course. Plasma concentrations of ITCZ can differ significantly depending on the patient or type of ITCZ. The ITCZ-plasma concentration should be controlled after changing from a brand-name-ITCZ to a generic ITCZ.

A system to test the ground surface conditions of construction sites--for safe and efficient work without physical strain.

Science.gov (United States)

Koningsveld, Ernst; van der Grinten, Maarten; van der Molen, Henk; Krause, Frank

2005-07-01

Ground surface conditions on construction sites have an important influence on the health and safety of workers and their productivity. The development of an expert-based "working conditions evaluation" system is described, intended to assist site managers in recognising unsatisfactory ground conditions and remedying these. The system was evaluated in the period 2002-2003. The evaluation shows that companies recognize poor soil/ground conditions as problematic, but are not aware of the specific physical workload hazards. The developed methods allow assessment of the ground surface quality and selection of appropriate measures for improvement. However, barriers exist at present to wide implementation of the system across the industry. Most significant of these is that responsibility for a site's condition is not clearly located within contracting arrangements, nor is it a topic of serious negotiation.

Effect of generic issues program on improving safety

International Nuclear Information System (INIS)

Fard, M. R.; Kauffman, J. V.

2010-01-01

The U.S. Nuclear Regulatory Commission (NRC) identifies (by its assessment of plant operation) certain issues involving public health and safety, the common defense and security, or the environment that could affect multiple entities under NRC jurisdiction. The Generic Issues Program (GIP) addresses the resolution of these Generic Issues (GIs). The resolution of these issues may involve new or revised rules, new or revised guidance, or revised interpretation of rules or guidance that affect nuclear power plant licensees, nuclear material certificate holders, or holders of other regulatory approvals. U.S. NRC provides information related to the past and ongoing GIP activities to the general public by the use of three main resources, namely NUREG-0933, 'Resolution of Generic Safety Issues, ' Generic Issues Management Control System (GIMCS), and GIP public web page. GIP information resources provide information such as historical information on resolved GIs, current status of the open GIs, policy documents, program procedures, GIP annual and quarterly reports and the process to contact GIP and propose a GI This paper provides an overview of the GIP and several examples of safety improvements resulting from the resolution of GIs. In addition, the paper provides a brief discussion of a few recent GIs to illustrate how the program functions to improve safety. (authors)

Analysis of the Italian generic medicines retail market: recommendations to enhance long-term sustainability.

Science.gov (United States)

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2015-02-01

Italy is among the European countries with the lowest uptake of generic medicines. This paper provides a perspective on the Italian generic medicines retail market. Fast market entrance of generic medicines in Italy is hindered by several factors: the existence of Complementary Protection Certificates in the past, the large market for copies and multiple cases of patent linkage. Prices of generic medicines in Italy are low compared to other European countries. To contain pharmaceutical expenditure, pharmaceutical companies are currently forced to pay back in case of overspending, which disproportionally penalizes small and fast growing companies, to which most generic companies belong to. Current demand-side policies do not successfully stimulate the use of generic medicines. The current market environment surrounding the Italian generic medicines retail market (i.e., low prices, low volumes) threatens its long-term sustainability. Recommendations to enhance the long-term sustainability of the Italian generic medicines retail market round off this perspective paper.

Do All Ducks Lay Eggs? The Generic Overgeneralization Effect

Science.gov (United States)

Leslie, Sarah-Jane; Khemlani, Sangeet; Glucksberg, Sam

2011-01-01

Generics are statements such as "tigers are striped" and "ducks lay eggs". They express general, though not universal or exceptionless, claims about kinds (Carlson & Pelletier, 1995). For example, the generic "ducks lay eggs" seems true even though many ducks (e.g. the males) do not lay eggs. The universally quantified version of the statement…

Optimisation of treatment, storage and disposal strategies for (unconditioned and conditioned) radioactive waste

International Nuclear Information System (INIS)

Bealby, J.

1989-03-01

This study examines the trade-offs involved between unconditioned and conditioned waste storage, by investigating the effects of different cost and environmental minimisation strategies on radioactive waste treatment and disposal strategies. The costs and environmental impacts from storage (unconditioned and conditioned), conditioning, transport and disposal are examined. A single generic mixed Magnox/AGR site is investigated, assuming a moderate nuclear power growth scenario over the period 1986 to 2030. Assessments have been performed for four weighting sets which cover the range of views perceived to exist about the relative importance of cost and environmental impact reduction. The base case conditioning option considers the availability of a LLW low force compaction plant in 1986 and two ILW conditioning plants (cement encapsulation and dissolution) in 1990. A base case set of disposal options considers the options of disposal to shallow land and burial facility and deep cavity facilities. The study investigates the effect of deferring the opening dates of the conditioning plants. A set of sensitivity studies show that the assessments are robust to the assumptions and impact parameters used. (author)

Development of a generic data base for failure rate

International Nuclear Information System (INIS)

Mosleh, A.; Apostolakis, G.

1985-01-01

The data analysis task in a probabilistic risk assessment (PRA) involves the assessment of data needs, the collection of information, and, finally, the analysis of the data to generate estimates for various parameters. This paper describes a framework for developing a data base for component failure rates and presents mathematical methods for the analysis of various types of information. The discussion is focused on the development of generic data bases used in PRAs. For plants without an operating history, the generic distributions are used directly to calculate component unavailability. In the case of plants that have operated for some time, the generic distributions can be used as priors in Bayesian analysis and, thus, specialized by plant-specific experience

Modelling and analysis of radionuclide dispersion from PWR on abnormal condition in Bojanegara Serang site

International Nuclear Information System (INIS)

Sri Kuntjoro

2010-01-01

Additional of electrical power especially Nuclear Power Plant will give radiological consequence sto population and environment due to radioactive release in normal and abnormal condition. In consequence the management of nuclear power plant must supply data and strong argumentation to clarify the safety of nuclear power plant to environment. For that purpose it needs to be carried out an analysis of abnormal condition in nuclear power plant and its radiological consequences to the environment. That analysis is done using abnormal condition simulation model postulated on 1000 MWe nuclear power plant.That simulation model is used also to evaluate environmental potential as site capability in supporting the radiological consequences. Radionuclide transport modeling from reactor core to containment uses EMERALD computer code. Other computer codes are Wind rose, PC-COSYMA and Arc View are used to simulate meteorology condition, radionuclide release to population distribution of food production and consumption and distribution of radiation dose received to population around nuclear power plant. Application of that simulation is carried out to NPP candidate site in Bojanegara-Kramatwatu, Serang Banten peninsula. Using source term data, meteorology data, dispersion data and pathways modeling are resulting radionuclide dispersion model and radiation pathway acceptance at the surrounding nuclear power plant site (Bojanegara-Serang peninsula). The result shows that maximum radiation dose received is lower than dose permitted in accordance with regulatory body (BAPETEN). (author)

'Genericism' in Danish welfare professions

DEFF Research Database (Denmark)

Larsen, Verner

and skills in the basic disciplines of the professions also termed as disciplinary and procedural knowledge '. Thus the main research question for this paper is: What consequences do recent reform actions in Danish welfare education concerning generic competence have on developing professional knowledge...

The impact of price-cap regulations on market entry by generic pharmaceutical firms.

Science.gov (United States)

Zhang, Wei; Sun, Huiying; Guh, Daphne; Anis, Aslam H

2017-04-01

In 1998, the province of Ontario, Canada implemented price-cap '70/90' regulations: the first generic must be priced at ≤70% of the associated brand-name price and subsequent generics must be priced at ≤90% of the first generics' price. The price-cap was further lowered to 50% in 2006 and 25% in 2010 for all generic drugs regardless of the first or subsequent generic entrants. This study assessed the impact of such price-cap regulations on market entry by generic firms using the formulary database from 9 provinces (January 2004-March 2013). A logistic regression was estimated to compare the probability of entry during the three policy periods in Ontario ('70/90', '25', versus '50'). Since different price-caps were subsequently introduced in other provinces, Alberta, British Columbia, New Brunswick and Saskatchewan, difference-in-differences was used to compare market entry. In Ontario, compared with the period '50', generic firms were 76% and 63% less likely to enter markets in the periods '25' and '70/90', respectively. The difference-in-differences showed that the entry probability decreased the most in Ontario during the '25' period from the '50' period. Lowering the price-cap level to 25% leads to a significantly lower probability of market entry by generic firms.

Policy objective of generic medicines from the investment perspective: The case of clopidogrel.

Science.gov (United States)

Elek, Péter; Harsányi, András; Zelei, Tamás; Csetneki, Kata; Kaló, Zoltán

2017-05-01

The objective of generic drug policies in most countries is defined from a disinvestment perspective: reduction in expenditures without compromising health outcomes. However, in countries with restricted access of patients to original patented drugs, the objective of generic drug policies can also be defined from an investment perspective: health gain by improved patient access without need for additional health budget. This study examines the investment aspect of generic medicines by analyzing clopidogrel utilization in European countries between 2004 and 2014 using multilevel panel data models. We find that clopidogrel consumption was strongly affected by affordability constraints before the generic entry around 2009, but this effect decayed by 2014. After controlling for other variables, utilization had a substantially larger trend increase in lower-income European countries than in the higher-income ones. Generic entry increased clopidogrel consumption only in lower- and average-income countries but not in the highest-income ones. An earlier generic entry was associated with a larger effect. The case of clopidogrel indicates that the entrance of generics may increase patient access to effective medicines, most notably in lower-income countries, thereby reducing inequalities between European patients. Policymakers should also consider this investment aspect of generic medicines when designing pharmaceutical policies. Copyright © 2017 Elsevier B.V. All rights reserved.

Potential Clinical and Economic Impact of Switching Branded Medications to Generics

Science.gov (United States)

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

Systematic identification of crystallization kinetics within a generic modelling framework

DEFF Research Database (Denmark)

Abdul Samad, Noor Asma Fazli Bin; Meisler, Kresten Troelstrup; Gernaey, Krist

2012-01-01

A systematic development of constitutive models within a generic modelling framework has been developed for use in design, analysis and simulation of crystallization operations. The framework contains a tool for model identification connected with a generic crystallizer modelling tool-box, a tool...

40 CFR 721.10063 - Halo substituted hydroxy nitrophenyl amide (generic).

Science.gov (United States)

2010-07-01

... amide (generic). 721.10063 Section 721.10063 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10063 Halo substituted hydroxy nitrophenyl amide (generic). (a) Chemical... as halo substituted hydroxy nitrophenyl amide (PMN P-04-792) is subject to reporting under this...

The generic drug user fee amendments: an economic perspective

Science.gov (United States)

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

Development of the NIREX generic transport safety assessment to assist in the provision of waste packaging advice

International Nuclear Information System (INIS)

Hutchinson, D.L.; Marrison, A.R.; Sievwright, R.W.T.

2002-01-01

The current Nirex Mission is to provide the United Kingdom with safe, environmentally sound and publicly acceptable options for the long-term management of radioactive materials. As part of this role, Nirex has developed a phased deep geological disposal concept which is defined by six 'generic documents' that describe systems, processes and safety assessments that are not specific to any one location or geology. These generic documents give access to detailed information about the ideas and approaches that underpin the phased disposal concept, and have been published with an invitation to enter into dialogue with Nirex regarding these issues. The generic documents identify the requirements for an integrated transport system that would be necessary for the management of the intermediate-level (ILW) and low-level (LLW) wastes within Nirex's remit - the so-called reference case volume. This has involved Nirex in the development of transport hardware and associated safety reports and modelling and assessment tools for transport system logistics and system safety. Although the phased disposal concept is only one option for the long-term management of waste, the integrated transport system and associated modelling tools, is likely to be of equal relevance to other options. The safety assessment of the generic transport operation for the movement of ILW and LLW waste from waste producers' sites to a future radioactive waste disposal facility is described in one of the generic documents - the generic transport safety assessment (GTSA). The GTSA demonstrates that the transport operation is compliant with Nirex safety principles, and that the nuclear and non-nuclear risks to the public and workers from routine transport and from accidents are acceptable. This paper describes the types of risk that are calculated, and discusses the data requirements and calculation methodology. The verification and validation methodology is outlined, together with a discussion of the results

A randomized, double-blind, cross-over, phase IV trial of oros-methylphenidate (CONCERTA(®)) and generic novo-methylphenidate ER-C (NOVO-generic).

Science.gov (United States)

Fallu, Angelo; Dabouz, Farida; Furtado, Melissa; Anand, Leena; Katzman, Martin A

2016-08-01

Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder with onset during childhood. Multiple aspects of a child's development are hindered, in both home and school settings, with negative impacts on social, emotional, and cognitive functioning. If left untreated, ADHD is commonly associated with poor academic achievement and low occupational status, as well as increased risk of substance abuse and delinquency. The objective of this study was to evaluate adult ADHD subject reported outcomes when switched from a stable dose of CONCERTA(®) to the same dose of generic Novo-methylphenidate ER-C(®). Randomized, double-blind, cross-over, phase IV trial consisted of two phases in which participants with a primary diagnosis of ADHD were randomized in a 1:1 ratio to 3 weeks of treatment with CONCERTA or generic Novo-Methylphenidate ER-C. Following 3 weeks of treatment, participants were crossed-over to receive the other treatment for an additional 3 weeks. Primary efficacy was assessed through the use of the Treatment Satisfaction Questionnaire for Medication, Version II (TSQM-II). Participants with ADHD treated with CONCERTA were more satisfied in terms of efficacy and side effects compared to those receiving an equivalent dose of generic Novo-Methylphenidate ER-C. All participants chose to continue with CONCERTA treatment at the conclusion of the study. Although CONCERTA and generic Novo-Methylphenidate ER-C have been deemed bioequivalent, however the present findings demonstrate clinically and statistically significant differences between generic and branded CONCERTA. Further investigation of these differences is warranted.

Impact of brand or generic labeling on medication effectiveness and side effects.

Science.gov (United States)

Faasse, Kate; Martin, Leslie R; Grey, Andrew; Gamble, Greg; Petrie, Keith J

2016-02-01

Branding medication with a known pharmaceutical company name or product name bestows on the drug an added assurance of authenticity and effectiveness compared to a generic preparation. This study examined the impact of brand name and generic labeling on medication effectiveness and side effects. 87 undergraduate students with frequent headaches took part in the study. Using a within-subjects counterbalanced design, each participant took tablets labeled either as brand name "Nurofen" or "Generic Ibuprofen" to treat each of 4 headaches. In reality, half of the tablets were placebos, and half were active ibuprofen (400 mg). Participants recorded their headache pain on a verbal descriptor and visual analogue scale prior to taking the tablets, and again 1 hour afterward. Medication side effects were also reported. Pain reduction following the use of brand name labeled tablets was similar in active ibuprofen or a placebo. However, if the tablets had a generic label, placebo tablets were significantly less effective compared to active ibuprofen. Fewer side effects were attributed to placebo tablets with brand name labeling compared to the same placebo tablets with a generic label. Branding of a tablet appears to have conferred a treatment benefit in the absence of an active ingredient, while generic labeled tablets were substantially less effective if they contained no active ingredient. Branding is also associated with reduced attribution of side effects to placebo tablets. Future interventions to improve perceptions of generics may have utility in improving treatment outcomes from generic drugs. (c) 2016 APA, all rights reserved).

76 FR 24920 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Science.gov (United States)

2011-05-03

... precision requirements or power calculations that justify the proposed sample size, the expected response... Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service... Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback...

76 FR 35069 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance...

Science.gov (United States)

2011-06-15

... precision requirements or power calculations that justify the proposed sample size, the expected response...; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on... (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery...

78 FR 74175 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Science.gov (United States)

2013-12-10

... precision requirements or power calculations that justify the proposed sample size, the expected response...: 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...

77 FR 52708 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Science.gov (United States)

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...

Generic hyper-diversity in Stachybotriaceae

Czech Academy of Sciences Publication Activity Database

Lombard, L.; Houbraken, J.; Decock, C.; Samson, R.A.; Meijer, M.; Réblová, Martina; Groenewald, J.Z.; Crous, P. W.

2016-01-01

Roč. 36, SI Jun (2016), s. 156-246 ISSN 0031-5850 R&D Projects: GA ČR GAP506/12/0038 Institutional support: RVO:67985939 Keywords : biodegraders * generic concept * human and plant pathogens Subject RIV: EF - Botanics Impact factor: 7.511, year: 2016

Stable Isotope Profiling of Internet-Sourced Viagra® and 'generic- Viagra' Tablets

Science.gov (United States)

Kemp, Helen; Meier-Augenstein, Wolfram

2013-04-01

Viagra® manufactured by Pfizer was the first prescription drug for the treatment of erectile dysfunction (ED), a condition that is estimated to affect 1 in 10 men at some stage in their lives (1). Viagra® contains the active pharmaceutical ingredient (API) sildenafil, as the citrate salt. Sildenafil, along with Tadalafil and Vardenafil belong to a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors. Since its first production in 1998, Viagra® has generated well in excess of 10 billion US dollars in sales (2) and with Pfizers' patent extended to April 2020 (3) it still remains the only sildenafil-based treatment option for sufferers of ED in the US. There are no legal 'generic-Viagra' formulations available in the US. However, formulations containing sildenafil citrate as API are widely available over the internet and often sold as 'generic Viagra'. These cheaper alternatives are often manufactured under less than ideal conditions with little or no QA/QC procedures in place. The World Health Organisation recognised the scale of the problem in its 2010 bulletin "Growing threat from counterfeit medicines" (4) and quotes a Dutch study cited in the International Journal of Clinical Practice in which from a cohort of 370 seized Viagra® samples, only 10 were genuine. We sourced a variety of tablets sold for the treatment of ED which claimed to have sildenafil citrate as API. Viagra®, 'generic-Viagra', Kamagra, Silagra and Filagra tablets were ordered via the internet and supplied from both UK-based pharmacies as well as overseas suppliers (Hong Kong, India, Vanuata). In this small-scale pilot study, we present results from bulk 2H/18O and 13C/15N stable isotope analysis performed on crushed tablets from 23 samples of internet-sourced tablets sold for the treatment of ED and purported to contain sildenafil citrate as API. References 1. www.healthcare.org.uk 2. www.moneynews.com 3. US Patent & trademark office (www.uspto.gov) 4. WHO bulletin 2010; 88:247-248

Underground siting of nuclear power plants: potential benefits and penalties

International Nuclear Information System (INIS)

Allensworth, J.A.; Finger, J.T.; Milloy, J.A.; Murfin, W.B.; Rodeman, R.; Vandevender, S.G.

1977-08-01

The potential for improving nuclear power safety is analyzed by siting plants underground in mined cavities or by covering plants with fill earth after construction in an excavated cut. Potential benefits and penalties of underground plants are referenced to analogous plants located on the surface. Three representative regional sites having requisite underground geology were used to evaluate underground siting. The major factors which were evaluated for all three sites were: (1) containment of radioactive materials, (2) transport of groundwater contamination, and (3) seismic vulnerability. External protection, plant security, feasibility, operational considerations, and cost were evaluated on a generic basis. Additionally, the national availability of sites having the requisite geology for both underground siting concepts was determined

Safety and efficacy of generic drugs with respect to brand formulation.

Science.gov (United States)

Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

2013-12-01

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

InP-based generic foundry platform for photonic integrated circuits

NARCIS (Netherlands)

Augustin, L.M.; Lemos Alvares Dos Santos, R.M.; den Haan, E.; Kleijn, S.E.F.; Thijs, P.J.A.; Latkowski, S.; Zhao, D.; Yao, W.; Bolk, J.; Ambrosius, H.P.M.M.; Mingaleev, S.; Richter, A.; Bakker, A.; Korthorst, T.

2017-01-01

The standardization of photonic integration processes for InP has led to versatile and easily accessible generic integration platforms. The generic integration platforms enable the realization of a broad range of applications and lead to a dramatic cost reduction in the development costs of photonic

Generic implications of ATWS events at the Salem Nuclear Power Plant: generic implications. Vol. 1

International Nuclear Information System (INIS)

1983-04-01

This report is the first of two volumes. It documents the work of an interoffice, interdisciplinary NRC Task Force established to determine the generic implications of two anticipated transients without scram (ATWS) at the Salem Nuclear Power Plant, Unit 1 on February 22 and 25, 1983. A second report will document the NRC actions to be taken based on the work of the Task Force. The Task Force was established to address three questions: (1) Is there a need for prompt action for similar equipment in other facilities. (2) Are NRC and its licensees learning the sefety-management lessons, and, (3) How should the priority and content of the ATWS rule be adjusted. A number of short-term actions were taken through Bulletins and an Information Notice. Intermediate-term actions to address the generic issues will be addressed in the separate report and implemented through appropriate regulatory mechanisms

Generic phase transitions and profit singularities in Arnol'd's model

International Nuclear Information System (INIS)

Davydov, Aleksei A; Matos, Helena Mena

2007-01-01

For a smooth one-parameter family of pairs of control systems and profit densities on a circle, the generic transitions between optimal rotations and stationary strategies are studied in the problem of maximization of the time-averaged profit on the infinite horizon. It is shown that there are only two types of such transitions, the corresponding singularities of the average profit as a function of the family parameter are found, and it is proved that these singularities are stable under small perturbations of a generic family. The classification of singularities of the maximum average profit is completed for generic families. Bibliography: 16 titles.

Business engineering. Generic Software Architecture in an Object Oriented View

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Mihaela MURESAN

2006-01-01

Full Text Available The generic software architecture offers a solution for the the information system's development and implementation. A generic software/non-software model could be developed by integrating the enterprise blueprint concept (Zachman and the object oriented paradigm (Coad's archetype concept. The standardization of the generic software architecture for various specific software components could be a direction of crucial importance, offering the guarantee of the quality of the model and increasing the efficiency of the design, development and implementation of the software. This approach is also useful for the implementation of the ERP systems designed to fit the user’s particular requirements.

77 FR 17493 - Agency Information Collection Activities: Proposed Collection; Comment Request; DOI Generic...

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2012-03-26

... justify the proposed sample size, the expected response rate, methods for assessing potential non...: Proposed Collection; Comment Request; DOI Generic Clearance for the Collection of Qualitative Feedback on... (Generic ICR): ``DOI Generic Clearance for the Collection of Qualitative Feedback on Agency Service...

75 FR 80542 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

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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...

76 FR 12140 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

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2011-03-04

... 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... Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback...

76 FR 19826 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

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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...

76 FR 17861 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

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2011-03-31

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods...; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery... Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback...

76 FR 25693 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

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2011-05-05

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service... Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency...

Compliance with Operational Circular No. 2 on conditions of access to the fenced CERN sites

CERN Multimedia

Relations with the Host States Service

2004-01-01

The purpose of Operational Circular No. 2 is to contribute to the protection of people and property by defining the conditions of access to the Organization's fenced sites. However, recently, the services concerned have noted a significant increase in the instances of non-compliance with those conditions that cannot be tolerated, for example: use of CERN access cards by people, other than the cardholders themselves, in order to gain access to facilities without having attended the required safety course; speeding, particularly on Route Gregory and Route Weisskopf; driving in and out of the site on the wrong side of the road; parking on spaces set aside for the disabled; nuisance parking, especially in the proximity of the Restaurants; the dumping of wrecked vehicles. As the aforementioned instances of non-compliance can lead to dangerous situations, the Organization reserves the right to apply the penalties provided for under paragraph 26 of Operational Circular No. 2, namely to refuse access to the site...

76 FR 79198 - Generic Drug User Fee; Public Meeting; Correction

Science.gov (United States)

2011-12-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION... meeting entitled ``Generic Drug User Fee.'' The document published with an inadvertent error in the Dates...

Modeling generic aspects of ideal fibril formation

Energy Technology Data Exchange (ETDEWEB)

Michel, D., E-mail: denis.michel@live.fr [Universite de Rennes1-IRSET, Campus de Beaulieu Bat. 13, 35042 Rennes (France)

2016-01-21

Many different proteins self-aggregate into insoluble fibrils growing apically by reversible addition of elementary building blocks. But beyond this common principle, the modalities of fibril formation are very disparate, with various intermediate forms which can be reshuffled by minor modifications of physico-chemical conditions or amino-acid sequences. To bypass this complexity, the multifaceted phenomenon of fibril formation is reduced here to its most elementary principles defined for a linear prototype of fibril. Selected generic features, including nucleation, elongation, and conformational recruitment, are modeled using minimalist hypotheses and tools, by separating equilibrium from kinetic aspects and in vitro from in vivo conditions. These reductionist approaches allow to bring out known and new rudiments, including the kinetic and equilibrium effects of nucleation, the dual influence of elongation on nucleation, the kinetic limitations on nucleation and fibril numbers, and the accumulation of complexes in vivo by rescue from degradation. Overlooked aspects of these processes are also pointed: the exponential distribution of fibril lengths can be recovered using various models because it is attributable to randomness only. It is also suggested that the same term “critical concentration” is used for different things, involved in either nucleation or elongation.

Discipline-Specific Compared to Generic Training of Teachers in Higher Education.

Science.gov (United States)

Silva-Fletcher, Ayona; May, Stephen A

A recurrent theme arising in the higher education sector is the suitability and effectiveness of generic versus discipline-specific training of university teachers, who are often recruited based on their disciplinary specialties to become teachers in higher education. We compared two groups of participants who had undergone training using a generic post-graduate certificate in higher education (PGCertGeneric) versus a discipline-specific course in veterinary education (PGCertVetEd). The study was conducted using a survey that allowed comparison of participants who completed PGCertGeneric (n=21) with PGCertVetEd (n=22). Results indicated that participants from both PGCertGeneric and PGCertVetEd considered teaching to be satisfying and important to their careers, valued the teaching observation component of the course, and identified similar training needs. However, the participants of the PGCertVetEd felt that the course made them better teachers, valued the relevance of the components taught, understood course design better, were encouraged to do further courses/reading in teaching and learning, changed their teaching as a result of the course, and were less stressed about teaching as compared to the PGCertGeneric participants (p<.05). It is likely that the PGCertVetEd, which was designed and developed by veterinarians with a wider understanding of the veterinary sector, helped the participants perceive the training course as suited to their needs.

Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

Directory of Open Access Journals (Sweden)

M Venkatesh

2011-01-01

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

Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

Science.gov (United States)

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

2011-01-01

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

Topological Hausdorff dimension and level sets of generic continuous functions on fractals

International Nuclear Information System (INIS)

Balka, Richárd; Buczolich, Zoltán; Elekes, Márton

2012-01-01

Highlights: ► We examine a new fractal dimension, the so called topological Hausdorff dimension. ► The generic continuous function has a level set of maximal Hausdorff dimension. ► This maximal dimension is the topological Hausdorff dimension minus one. ► Homogeneity implies that “most” level sets are of this dimension. ► We calculate the various dimensions of the graph of the generic function. - Abstract: In an earlier paper we introduced a new concept of dimension for metric spaces, the so called topological Hausdorff dimension. For a compact metric space K let dim H K and dim tH K denote its Hausdorff and topological Hausdorff dimension, respectively. We proved that this new dimension describes the Hausdorff dimension of the level sets of the generic continuous function on K, namely sup{ dim H f -1 (y):y∈R} =dim tH K-1 for the generic f ∈ C(K), provided that K is not totally disconnected, otherwise every non-empty level set is a singleton. We also proved that if K is not totally disconnected and sufficiently homogeneous then dim H f −1 (y) = dim tH K − 1 for the generic f ∈ C(K) and the generic y ∈ f(K). The most important goal of this paper is to make these theorems more precise. As for the first result, we prove that the supremum is actually attained on the left hand side of the first equation above, and also show that there may only be a unique level set of maximal Hausdorff dimension. As for the second result, we characterize those compact metric spaces for which for the generic f ∈ C(K) and the generic y ∈ f(K) we have dim H f −1 (y) = dim tH K − 1. We also generalize a result of B. Kirchheim by showing that if K is self-similar then for the generic f ∈ C(K) for every y∈intf(K) we have dim H f −1 (y) = dim tH K − 1. Finally, we prove that the graph of the generic f ∈ C(K) has the same Hausdorff and topological Hausdorff dimension as K.

Validation of Generic Models for Variable Speed Operation Wind Turbines Following the Recent Guidelines Issued by IEC 61400-27

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Andrés Honrubia-Escribano

2016-12-01

Full Text Available Considerable efforts are currently being made by several international working groups focused on the development of generic, also known as simplified or standard, wind turbine models for power system stability studies. In this sense, the first edition of International Electrotechnical Commission (IEC 61400-27-1, which defines generic dynamic simulation models for wind turbines, was published in February 2015. Nevertheless, the correlations of the IEC generic models with respect to specific wind turbine manufacturer models are required by the wind power industry to validate the accuracy and corresponding usability of these standard models. The present work conducts the validation of the two topologies of variable speed wind turbines that present not only the largest market share, but also the most technological advances. Specifically, the doubly-fed induction machine and the full-scale converter (FSC topology are modeled based on the IEC 61400-27-1 guidelines. The models are simulated for a wide range of voltage dips with different characteristics and wind turbine operating conditions. The simulated response of the IEC generic model is compared to the corresponding simplified model of a wind turbine manufacturer, showing a good correlation in most cases. Validation error sources are analyzed in detail, as well. In addition, this paper reviews in detail the previous work done in this field. Results suggest that wind turbine manufacturers are able to adjust the IEC generic models to represent the behavior of their specific wind turbines for power system stability analysis.

Non-unique inclusion in a flow and vast centralizer of a generic measure-preserving transformation

International Nuclear Information System (INIS)

Stepin, A M; Eremenko, A M

2004-01-01

The problem of the inclusion in a flow is considered for a measure-preserving transformation. It is shown that if a transformation T has a simple spectrum, then the set of flows including T - provided that it is not empty - consists either of a unique element or of infinitely many spectrally non-equivalent flows. It is proved that, generically, inclusions in a flow are maximally non-unique in the following sense: the centralizer of a generic transformation contains a subgroup isomorphic to an infinite-dimensional torus. The corresponding proof is based on the so-called dynamical alternative, a topological analogue of Fubini's theorem, a fundamental fact from descriptive set theory about the almost openness of analytic sets, and Dougherty's lemma describing conditions ensuring that the image of a separable metric space is a second-category set.

Perception of the value of generic drugs in São Paulo, Brazil

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Elene Paltrinieri Nardi

2016-01-01

Full Text Available Abstract The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%, and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.

Perception of the value of generic drugs in São Paulo, Brazil.

Science.gov (United States)

Nardi, Elene Paltrinieri; Ferraz, Marcos Bosi

2016-02-01

The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i) 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii) 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii) 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%), and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.

The Acquisition of Generic Skills of Culturally-Diverse Student Cohorts

Science.gov (United States)

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…

Testing properties of generic functions

NARCIS (Netherlands)

Jansson, P.; Jeuring, J.T.; Cabenda, L.; Engels, G.; Kleerekoper, J.; Mak, S.; Overeem, M.; Visser, Kees

2007-01-01

A datatype-generic function is a family of functions indexed by (the structure of) a type. Examples include equality tests, maps and pretty printers. Property based testing tools like QuickCheck and Gast support the de¯nition of properties and test-data generators, and they check if a

How can pharmacist remuneration systems in Europe contribute to generic medicine dispensing?

Directory of Open Access Journals (Sweden)

Dylst P

2012-03-01

Full Text Available Generic medicines can generate larger savings to health care budgets when their use is supported by incentives on both the supply-side and the demand-side. Pharmacists’ remuneration is one factor influencing the dispensing of generic medicines.Objective: The aim of this article is to provide an overview of different pharmacist remuneration systems for generic medicines in Europe, with a view to exploring how pharmacist remuneration systems can contribute to generic medicine dispensing.Methods: Data were obtained from a literature review, a Master thesis in Pharmaceutical Care at the Catholic University of Leuven and a mailing sent to all members of the Pharmaceutical Group of the European Union with a request for information about the local remuneration systems of community pharmacists and the possible existence of reports on discounting practices.Results: Pharmacists remuneration in most European countries consists of the combination of a fixed fee per item and a certain percentage of the acquisition cost or the delivery price of the medicines. This percentage component can be fixed, regressive or capped for very high-cost medicines and acts as a disincentive for dispensing generic medicines. Discounting for generic medicines is common practice in several European countries but information on this practice tends to be confidential. Nevertheless, data for Belgium, France, the Netherlands and United Kingdom indicated that discounting percentages varied from 10% to 70% of the wholesale selling price.Conclusion: Pharmacists can play an important role in the development of a generic medicines market. Pharmacists should not be financially penalized for dispensing generic medicines. Therefore, their remuneration should move towards a fee-for-performance remuneration instead of a price-dependent reimbursement which is currently used in many European countries. Such a fee-for-performance remuneration system provides a stimulus for generic medicines

Medication persistence and the use of generic and brand-name blood pressure-lowering agents.

Science.gov (United States)

Corrao, Giovanni; Soranna, Davide; La Vecchia, Carlo; Catapano, Alberico; Agabiti-Rosei, Enrico; Gensini, Gianfranco; Merlino, Luca; Mancia, Giuseppe

2014-05-01

Because of their lower cost, healthcare systems recommend physicians to prefer generic products, rather than brand-name medicaments. There is then considerable interest and debate concerning safety and effectiveness of generic products. Few studies have compared patients treated with brand-name and generic drugs for adherence to treatment, with somewhat inconsistent results. The primary objective of this study was to compare the risk of discontinuing antihypertensive drug therapy in patients treated with generic or brand-name agents. The 101,618 beneficiaries of the Healthcare system of Lombardy, Italy, aged 18 years or older who were newly treated on monotherapy with antihypertensive generic or brand-name drugs during 2008, were followed until the earliest date among those of the occurrence of treatment discontinuation to whatever antihypertensive drug therapy (outcome), or censoring (death, emigration, 12 months after treatment initiation). Hazard ratios of discontinuation associated with starting on generic or brand-name products (intention-to-treat analysis), and incidence rate ratio of discontinuation during periods on generic and brand-name products (as-treated analysis) were respectively estimated from a cohort and self-controlled case series analyses. Patients who started on generics did not experience a different risk of discontinuation compared with those starting on brand-name agents (hazard ratio: 1.00; 95% confidence interval 0.98-1.02). Discontinuation did not occur with different rates during periods covered by generics or brand-name agents (incidence rate ratio: 1.01; 95% confidence interval 0.96-1.11) within the same individuals. A number of sensitivity and subgroup analyses confirmed the robustness of these findings. Generic products are not responsible for the high rate of discontinuation from antihypertensive drug therapy. Assuming therapeutic equivalence, clinical implication is of prescribing generic drug therapies.

[Acceptance of generic prescribing in general practice: effect of patient education and reference prices].

Science.gov (United States)

Vallès, J A; Barreiro, M; Cereza, G; Ferro, J J; Martínez, M J; Cucurull, E; Barceló, E

2002-01-01

To assess patient acceptance of the substitution of brand-name drugs for generic equivalents in the context of repeat prescriptions for chronic diseases. A prospective multicenter study of drug use was performed. Of the 31 centers included in the study, 8 were randomized to the intervention group and 23 to the control group. For 1 year, patients in the intervention group who visited the center to collect repeat prescriptions received verbal and written information on the advantages and disadvantages of generic and brand name drugs. Data on the number of patients taking brand-name drugs for which generic equivalents were available, as well as the reasons and variables related to refusal of generic drugs (age, gender, education, primary care centre, general practitioner, type of drug and total number of repeat prescriptions) were collected. The percentage of generic drugs among the total number of drugs prescribed was calculated at 2-monthly intervals. A total of 98.9% of the 4620 patients in the intervention group agreed to change to a generic formulation. The percentage of patients accepting generic drugs was significantly associated with the primary care centre, the class of drug, doctors' influence, and patient satisfaction with the drug. Generic prescriptions represented 5.9% in the intervention practices compared with 2.8% in controls. After the intervention, and before the application of reference prices, the percentages were 6.7% and 3.9%, respectively. Immediately after application of the reference prices, the percentages were 8.6% and 6.3%, respectively. Direct patient education is an effective strategy in increasing the prescription of generic equivalents. General practitioners' motivation and knowledge of generic drugs influenced their use. The application of reference prices increased the use of generic equivalents.

Exploring knowledge perceptions and attitudes about generic medicines among finalyear health science students

Directory of Open Access Journals (Sweden)

Varsha Bangalee

2016-05-01

Full Text Available Background. The use of generic medicines to reduce healthcare costs has become a mandated policy in South Africa. An increase in the use of generics can be achieved through improved knowledge, attitudes and perceptions of generic medicine among healthcare professionals. Objective. To explore knowledge, attitudes and perceptions among final-year health science students on generic medication. Methods. A cross-sectional survey was carried out among the final-year audiology, dental therapy, pharmacy, physiotherapy, occupational therapy, optometry, speech-language and sport science students enrolled at the University of KwaZulu-Natal. A questionnaire was used as the study tool, developed using information adapted from literature reviews. Data analysis was completed using Statistical Package for the Social Sciences (SPSS version 21, and computed using descriptive statistics. Results. Total number of participants was 211, as follows: audiology (n=14, dental therapy (n=15, pharmacy (n=81, physiotherapy (n=41, occupational therapy (n=6, optometry (n=25, speech-language (n=6 and sport science (n=23. A total of 90.0% of students had heard of generic medicines, with 20.9% of them agreeing that generic medicines are less effective than brand-name medicines. Concerning safety, 30.4% believed that brand-name medicines are required to meet higher safety standards than generic medicines. Regarding the need for information on issues pertaining to safety and efficacy of medicines, 53.3% of participants felt that this need was not being met. Conclusion. All groups had knowledge deficits about the safety, quality and efficacy of generic medicines. The dissemination of information about generic medicines may strengthen future knowledge, attitudes and perceptions.

Applicability of a generic monitoring program for radioactive waste burial grounds at Oak Ridge National Laboratory and Idaho National Engineering Laboratory

International Nuclear Information System (INIS)

1978-07-01

Six burial grounds were evaluated at Oak Ridge to determine which would be most suitable for testing the generic monitoring approach, and two were selected. Burial Ground 4 was chosen because it is known to be leaking radioactivity and a monitoring program is desirable to determine the source, pattern and extent of the leakage. Burial Ground 6 was chosen because the most complete radiologic and geologic data is available and modern burial practices have been utilized at this site. At the Idaho National Engineering Laboratory (INEL) only one burial ground exists, the Radioactive Waste Management Complex (RWMC). The data available on the burial grounds are insufficient for an adequate understanding of radionuclide migration patterns and accordingly, inadequate for the design of reliable monitoring programs. It was decided, therefore, that preliminary monitoring programs should be designed in order to obtain additional data for a later implementation of reliable monitoring programs. The monitoring programs designed for ORNL consist primarily of the installation of surface water monitoring stations, the surveillance of trench sump wells, a test boring program to study subsurface geologic conditions, a ground water sampling program and the installation of instrumentation, specifically infiltrometers and evaporation pans, to develop data on site water balances. The program designed for the INEL burial ground includes installation of trench sumps, a ground water monitoring program, test borings to further define subsurface geohydrologic conditions and the installation of instrumentation to develop data on the site water balance. The estimated costs of implementing the recommended programs are about $420,820 for monitoring Burial Grounds 4 and 6 at Oak Ridge and $382,060 for monitoring the RWMC at INEL. 12 figures

Formulation of Generic Simulation Models for Analyzing Construction Claims

Directory of Open Access Journals (Sweden)

Rifat Rustom

2012-11-01

Full Text Available While there are several techniques for analyzing the impact of claims on time schedule and productivity,very few are considered adequate and comprehensive to consider risks and uncertainties.A generic approach for claims analysis using simulation is proposed. The formulation of the generic methodology presented in this paper depends on three simulation models;As-Planned Model (APM,As-Built Model (ABM, and What-Would-HaveBeenModel(WWHBM. The proposed generic methodology as presented in this paper provides a good basis as a more elaborate approach to better analyze claims and their impacts on project time and productivity utilizing discrete event simulation.The approach proposed allows for scenario analysis to account for the disputed events and workflow disruptions. The proposed models will assist claimants in presenting their cases effectively and professionally.

The impact of generic language about ability on children's achievement motivation.

Science.gov (United States)

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.

Generic features of Einstein-Aether black holes

International Nuclear Information System (INIS)

Tamaki, Takashi; Miyamoto, Umpei

2008-01-01

We reconsider spherically symmetric black hole solutions in Einstein-Aether theory with the condition that this theory has identical parametrized post-Newtonian parameters as those for general relativity, which is the main difference from the previous research. In contrast with previous study, we allow superluminal propagation of a spin-0 Aether-gravity wave mode. As a result, we obtain black holes having a spin-0 'horizon' inside an event horizon. We allow a singularity at a spin-0 horizon since it is concealed by the event horizon. If we allow such a configuration, the kinetic term of the Aether field can be large enough for black holes to be significantly different from Schwarzschild black holes with respect to Arnowitt-Deser-Misner mass, innermost stable circular orbit, Hawking temperature, and so on. We also discuss whether or not the above features can be seen in more generic vector-tensor theories

Impact of European pharmaceutical price regulation on generic price competition: a review.

Science.gov (United States)

Puig-Junoy, Jaume

2010-01-01

Although economic theory indicates that it should not be necessary to intervene in the generic drug market through price regulation, most EU countries intervene in this market, both by regulating the maximum sale price of generics (price cap) and by setting the maximum reimbursement rate, especially by means of reference pricing systems. We analyse current knowledge of the impact of direct price-cap regulation of generic drugs and the implementation of systems regulating the reimbursement rate, particularly through reference pricing and similar tools, on dynamic price competition between generic competitors in Europe. A literature search was carried out in the EconLit and PubMed databases, and on Google Scholar. The search included papers published in English or Spanish between January 2000 and July 2009. Inclusion criteria included that studies had to present empirical results of a quantitative nature for EU countries of the impact of price capping and/or regulation of the reimbursement rate (reference pricing or similar systems) on price dynamics, corresponding to pharmacy sales, in the generic drug market. The available evidence indicates that price-cap regulation leads to a levelling off of generic prices at a higher level than would occur in the absence of this regulation. Reference pricing systems cause an obvious and almost compulsory reduction in the consumer price of all pharmaceuticals subject to this system, to a varying degree in different countries and periods, the reduction being greater for originator-branded drugs than for generics. In several countries with a reference pricing system, it was observed that generics with a consumer price lower than the reference price do not undergo price reductions until the reference price is reduced, even when there are other lower-priced generics on the market (absence of price competition below the reference price). Beyond the price reduction forced by the price-cap and/or reference pricing regulation itself

Generic trajectory representation and trajectory following for wheeled robots

DEFF Research Database (Denmark)

Kjærgaard, Morten; Andersen, Nils Axel; Ravn, Ole

2014-01-01

will drive. Safe: Avoid fatal collisions. Based on a survey of existing methods and algorithms the article presents a generic way to represent constraints for different types of robots, a generic way to represent trajectories using Bëzier curves, a method to convert the trajectory so it can be driven...... in a smooth motion, a method to create a safe velocity profile for the robot, and a path following controller....

Generic and Brand Advertising Strategies in a Dynamic Duopoly

OpenAIRE

Frank M. Bass; Anand Krishnamoorthy; Ashutosh Prasad; Suresh P. Sethi

2005-01-01

To increase the sales of their products through advertising, firms must integrate their brand-advertising strategy for capturing market share from competitors and their generic-advertising strategy for increasing primary demand for the category. This paper examines whether, when, and how much brand advertising versus generic advertising should be done. Using differential game theory, optimal advertising decisions are obtained for a dynamic duopoly with symmetric or asymmetric competitors. We ...

Choosing the best meteorological conditions for atmospheric diffusion experiments at the Angra site

International Nuclear Information System (INIS)

Nicolli, D.; Thomas, P.

1983-01-01

The most appropriate meteorological conditions and time of the day advisable for carrying out diffusion experiments at the Angra site are described. Two emission points were defined, and the sampling area was determined with easy access to the complex terrain taken into consideration. The onsite meteorological measuring system is briefly described. (Author) [pt

Siting Process for HLW Repository in Japan

International Nuclear Information System (INIS)

Masuda, S.; Kitayama, K.; Umeki, H.; Naito, M.

2002-01-01

In the year 2000, the geological disposal program for high-level radioactive waste in Japan moved from the phase of generic research and development (R and D) into the phase of implementation. Following legislation entitled the ''Specified Radioactive Waste Final Disposal Act'', the Nuclear Waste Management Organization of Japan (NUMO) was established as the implementing organization. The assigned activities of NUMO include selection of the repository site, demonstration of disposal technology at the site, developing relevant licensing applications and construction, operation and closure of the repository. As the first milestone of siting process, NUMO announced to the public an overall procedure for selection of preliminary investigation areas for potential candidate sites on October 29, 2001. The procedure specifies that NUMO will solicit volunteer municipalities for preliminary investigation areas with publishing four documents as an information package. These documents are tentatively entitled ''Instructions for Application'', ''Siting Factors for the Preliminary Investigation Areas'', a ''Repository Concepts'' as well as an ''Site Investigation Community Outreach Scheme''

Complex dynamics of the generic and brand advertising strategies in duopoly

International Nuclear Information System (INIS)

Qi Jie; Ding Yongsheng; Chen Liang

2008-01-01

By using the optimal profit adjusting strategies, a dynamic advertising competition model in duopoly is extended from Krishnamurthy's static model. Both generic and brand effects for advertising are considered. This model can create complex bifurcating and chaotic behavior for the generic advertising efforts, which lead to chaotic dynamics for the brand advertising and even for the whole system. The asymptotic properties of the symmetric system and the asymmetric system are also investigated, which reflect interactions between the two firms' advertising strategies and relationships between the brand and the generic advertising expenditures

Complex dynamics of the generic and brand advertising strategies in duopoly

Energy Technology Data Exchange (ETDEWEB)

Qi Jie [College of Information Sciences and Technology, Donghua University, Shanghai 200051 (China)], E-mail: jieqi@dhu.edu.cn; Ding Yongsheng [College of Information Sciences and Technology, Donghua University, Shanghai 200051 (China)], E-mail: ysding@dhu.edu.cn; Chen Liang [College of Information Sciences and Technology, Donghua University, Shanghai 200051 (China)

2008-04-15

By using the optimal profit adjusting strategies, a dynamic advertising competition model in duopoly is extended from Krishnamurthy's static model. Both generic and brand effects for advertising are considered. This model can create complex bifurcating and chaotic behavior for the generic advertising efforts, which lead to chaotic dynamics for the brand advertising and even for the whole system. The asymptotic properties of the symmetric system and the asymmetric system are also investigated, which reflect interactions between the two firms' advertising strategies and relationships between the brand and the generic advertising expenditures.

New Reactor Siting, Licensing and Construction Experience. Proceedings of the 2. CNRA International Workshop on 'New Reactor Siting, Licensing and Construction Experience'

International Nuclear Information System (INIS)

2013-01-01

This report documents the proceedings from the 2. Workshop on New Reactor Siting, Licensing and Construction Experience. A total of 45 specialists from 16 countries and international organisations attended. The meeting was sponsored by the OECD Nuclear Energy Agency Committee on Nuclear Regulatory Activities and hosted by the US Nuclear Regulatory Commission (U.S.NRC). The objectives of the workshop were to provide a forum to exchange information on lessons learned from siting, licensing and constructing new nuclear power plants around the world. Key focus areas included siting practices and regulatory positions that have been enhanced as a result of the Fukushima accident; lessons learned from licensing and design review approaches and challenges, construction experience and recommendations for regulatory oversight; and regulatory cooperation on generic and design specific issues through the MDEP specific working groups. The workshop was structured in 4 technical sessions, each followed by ample time for panel discussions. The first technical session was devoted to regulatory cooperation on generic and design specific issues, MDEP working groups (EPR, AP1000), vendor inspection co-operation, digital I and C, and codes and standards. The second technical session was intended to discuss and share regulatory positions on siting practices and enhancements as a result of lessons learned from Fukushima accident. The third technical session addressed the construction experience and regulatory oversight of new reactor construction activities. And the fourth technical session included presentations on the lessons learned from regulatory licensing reviews of new reactor designs

40 CFR 721.10097 - Disubstituted benzenesulfonic acid, alkali metal salt (generic).

Science.gov (United States)

2010-07-01

... chemical substance identified generically as disubstituted benzenesulfonic acid, alkali metal salt (PMN P... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Disubstituted benzenesulfonic acid, alkali metal salt (generic). 721.10097 Section 721.10097 Protection of Environment ENVIRONMENTAL...

76 FR 59379 - Proposed Information Collection; Comment Request; Generic Clearance for Research in Development...

Science.gov (United States)

2011-09-26

...-XXXX. Type of Review: Generic Clearance Request. Title: Generic Clearance for Research in Development... information collected through qualitative evaluation methods will inform the disclosure form's design and... Proposed Information Collection; Comment Request; Generic Clearance for Research in Development of...

Interventions promoting the acceptance and uptake of generic medicines: a narrative review of the literature.

Science.gov (United States)

Babar, Z U D; Kan, S W; Scahill, S

2014-09-01

The objective of this paper was to undertake a narrative review of the literature regarding strategies and interventions promoting the acceptance and uptake of generic medicines. A literature search was performed between November 2011 and January 2012 to identify published full text original research articles documenting interventions to promote the use of generic medicines. Keywords used were: "generic medicine", "generic drug", "intervention", "promotion", "acceptance", "uptake", "generic/therapeutic substitution" and their related root words. The electronic databases comprised of Embase (1980 - present), Google, Google Scholar, Medline (1948 - present), PubMed, Science Direct, Scopus, Springer Link and The Cochrane Library. An interpretative narrative synthesis was undertaken and emergent themes analysed and reported. Eighteen studies were included in the final analysis. There were seven main themes which including; education, financial incentives, advertising to promote generic medicines, free generic medicine trials, administrative forms and medicines use review (MUR). These themes were further classified into subthemes. Education was subdivided into consumer and physician education. Financial incentives included the influence of financial incentives on both consumers and physicians. The subthemes in the financial incentives category included the changes in co-payment for consumers, reward payment for physicians and fund-holding schemes. Advertising included the sub-themes of print media and the use of anthropomorphic images, while free generic medicines trial was made up of free vouchers for generic medicines and generic medicines sampling system. The studies have mixed results; some interventions in some settings were useful, while others were not. Not all interventions consistently improved the uptake of generic medicines. There was limited literature available and further work is required to develop a range of interventions to support the uptake of generic

Assessment of the living and workplace health and safety conditions of site-resident construction workers in Tehran, Iran.

Science.gov (United States)

Mohseni, Peyman Hossein; Farshad, Ali Asghar; Mirkazemi, Roksana; Orak, Rouhangiz Jamshidi

2015-01-01

The purpose of this study was to assess living and workplace safety conditions of construction workers in Tehran, Iran. This cross-sectional study was conducted among 410 construction sites in a municipal area of Tehran whose municipal building permits were issued in 2011. Data on ventilation, workplace safety and hygiene were collected by direct observation and interviews with site foremen. Noise levels were estimated from 10 sound-level-meter stations in the municipality area. Lack of ventilation in the workers' rooms was abundant. Bathrooms were unhygienic and minimum requirements such as lighting and ventilation did not exist in 80% of the cases. In nearly 50% of large construction sites, sewage and garbage disposal were inappropriate. Elevator safety was poor at all sites and no measures for fall prevention were present in over 88% of active construction sites. This study showed that the mean 24-h equivalent continuous sound level Leq was over 70 dB in 80% of the sites during weekdays. The results of this study revealed poor health and safety living and working conditions of construction workers in Tehran.

Promoting and regulating generic medicines: Brazil in comparative perspective

Directory of Open Access Journals (Sweden)

Elize Massard da Fonseca

2017-04-01

Full Text Available ABSTRACT 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.

Operational Circular No. 2 (Rev. 3) - Conditions of access to the fenced parts of the CERN site

CERN Multimedia

HR Department

2015-01-01

Operational Circular No. 2 (Rev. 3) entitled "Conditions of access to the fenced parts of the CERN site", approved by the Director-General following discussion in the Standing Concertation Committee meeting on 24 September 2015, is now available via this link.   This revised circular cancels and replaces Operational Circular No. 2 (Rev. 2) also entitled "Conditions of access to the fenced parts of the CERN site", of September 2014. The circular was revised predominantly in order to specify that access to the CERN site is granted to CERN Pension Fund beneficiaries only provided that they are actually in receipt of payments from the Fund; and to allow the Director-General to permit special types of vehicles on site, such as trailers. It also includes a certain number of text improvements and an updated version of the implementation measures, in particular with regard to vehicle identification, road traffic and parking.  

Study of seismic design bases and site conditions for nuclear power plants

International Nuclear Information System (INIS)

1980-04-01

This report presents the results of an investigation of four topics pertinent to the seismic design of nuclear power plants: Design accelerations by regions of the continental United States; review and compilation of design-basis seismic levels and soil conditions for existing nuclear power plants; regional distribution of shear wave velocity of foundation materials at nuclear power plant sites; and technical review of surface-founded seismic analysis versus embedded approaches

Study of seismic design bases and site conditions for nuclear power plants

Energy Technology Data Exchange (ETDEWEB)

1980-04-01

This report presents the results of an investigation of four topics pertinent to the seismic design of nuclear power plants: Design accelerations by regions of the continental United States; review and compilation of design-basis seismic levels and soil conditions for existing nuclear power plants; regional distribution of shear wave velocity of foundation materials at nuclear power plant sites; and technical review of surface-founded seismic analysis versus embedded approaches.

National Ignition Facility subsystem design requirements NIF site improvements SSDR 1.2.1

International Nuclear Information System (INIS)

Kempel, P.; Hands, J.

1996-01-01

This Subsystem Design Requirements (SSDR) document establishes the performance, design, and verification requirements associated with the NIF Project Site at Lawrence Livermore National Laboratory (LLNL) at Livermore, California. It identifies generic design conditions for all NIF Project facilities, including siting requirements associated with natural phenomena, and contains specific requirements for furnishing site-related infrastructure utilities and services to the NIF Project conventional facilities and experimental hardware systems. Three candidate sites were identified as potential locations for the NIF Project. However, LLNL has been identified by DOE as the preferred site because of closely related laser experimentation underway at LLNL, the ability to use existing interrelated infrastructure, and other reasons. Selection of a site other than LLNL will entail the acquisition of site improvements and infrastructure additional to those described in this document. This SSDR addresses only the improvements associated with the NIF Project site located at LLNL, including new work and relocation or demolition of existing facilities that interfere with the construction of new facilities. If the Record of Decision for the PEIS on Stockpile Stewardship and Management were to select another site, this SSDR would be revised to reflect the characteristics of the selected site. Other facilities and infrastructure needed to support operation of the NIF, such as those listed below, are existing and available at the LLNL site, and are not included in this SSDR. Office Building. Target Receiving and Inspection. General Assembly Building. Electro- Mechanical Shop. Warehousing and General Storage. Shipping and Receiving. General Stores. Medical Facilities. Cafeteria services. Service Station and Garage. Fire Station. Security and Badging Services

Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial.

Directory of Open Access Journals (Sweden)

Rita R Alloway

2017-11-01

Administration (FDA average bioequivalence (ABE acceptance criteria of a 90% confidence interval contained within the confidence limits of 80.00% and 125.00%. Within-subject variability was similar for the area under the curve (AUC (range 12.11-15.81 and the concentration maximum (Cmax (range 17.96-24.72 for all products. The within-subject variability was utilized to calculate the scaled average bioequivalence (SCABE 90% confidence interval. The calculated SCABE 90% confidence interval was 84.65%-118.13% and 80.00%-125.00% for AUC and Cmax, respectively. The more stringent SCABE acceptance criteria were met for all product comparisons for AUC and Cmax in both individuals with a kidney transplant and those with a liver transplant. European Medicines Agency (EMA acceptance criteria for narrow therapeutic index drugs were also met, with the only exception being in the case of Brand versus Generic Lo, in which the upper limits of the 90% confidence intervals were 111.30% (kidney and 112.12% (liver. These were only slightly above the upper EMA acceptance criteria limit for an AUC of 111.11%. SCABE criteria were also met for the major tacrolimus metabolite 13-O-desmethyl tacrolimus for AUC, but it failed the EMA criterion. No acute rejections, no differences in renal function in all individuals, and no differences in liver function were observed in individuals with a liver transplant using the Tukey honest significant difference (HSD test for multiple comparisons. Fifty-two percent and 65% of all individuals with a kidney or liver transplant, respectively, reported an adverse event. The Exact McNemar test for paired categorical data with adjustments for multiple comparisons was used to compare adverse event rates among the products. No statistically significant differences among any pairs of products were found for any adverse event code or for adverse events overall. Limitations of this study include that the observations were made under strictly controlled conditions that did not

Generic Structure Potential of Christian Apologetics

Directory of Open Access Journals (Sweden)

Onwu Inya

2012-01-01

Full Text Available Religious texts have been examined by scholars from different theoretical standpoints. However, a close survey of the literature reveals that little attention has been paid to Christian apologetics from a linguistic perspective. Also, an examination of studies along the lines of Generic Structure Potential (henceforth GSP shows that the genre status of Christian apologetics has not been indicated. This gap provides the motivation for this paper, which investigates the GSP of Christian apologetics. Twenty texts written by various key contemporary apologetic writers were purposively selected for the study. The following generic structure potential catalogue was generated:The paper reveals that the elements of the GSP concertedly work to advance, argue for or defend the Christian belief system. The paper also suggests that the model could be applied to other forms of apologetic instances.

Exploring the opinions and experiences of patients with generic substitution: a representative study of Polish society.

Science.gov (United States)

Drozdowska, Aleksandra; Hermanowski, Tomasz

2015-02-01

Generics have the potential to contain drug therapy costs; successful implementation of generic substitution policy largely depends on consumers' willingness to choose generics. This study aims to analyse the opinions, experiences and preferences of Polish patients towards generic medicines. The study was performed in Poland. The survey was conducted in June 2013 by means of face-to-face interviews. Respondents were drawn from the general population according to a population structure. The study covered a representative sample of 1,000 Poles; the results can be generalized to apply to the Polish population at large. Fifty-two percent of respondents declared to be more often choosing generics, twenty-three percent did not have any specific preferences, and twenty-five percent were more willing to choose brand-name medicines. Past experience with cheaper generic medicines, secondary or lower education, low income and residence in specific regions of Poland were all significantly associated with an increased willingness to choose generics. Respondents' attitudes towards generics were mostly influenced by the opinions of doctors and pharmacists. According to respondents, attitudes towards generics among doctors, pharmacists, family and friends, and in the mass media were mostly positive. There was no relationship between the preference of respondents for generics and factors such as their age, life stage, gender, household size or urban/rural locality. As a result of substituting a brand-name drug with its generic equivalent, 72 % of respondents reported that they had not noticed any difference in drug effectiveness; 21 % had experienced a reduced effectiveness of treatment or increased side effects at least once; and 7 % claimed the generic worked better. The majority of respondents who used cheaper substitutes claimed that generics represented good or very good quality. The study demonstrates that, when choosing medicines, Poles rely mainly on the opinions of their

Factors affecting the opinions of family physicians regarding generic drugs – a questionnaire based study

Directory of Open Access Journals (Sweden)

Pawel Lewek

2014-12-01

Full Text Available A range of factors are believed to exert a negative influence on opinions of physicians about generic drugs.The aim of this study was to survey the opinions of primary care doctors on generics, and determine the factors which may affect them. A questionnaire comprising thirty eight questions was distributed among primary care doctors working in seventy out-patient clinics of the Lodzkie province, Poland, during the period of January 1, 2010 – December 31, 2010. A total of170 of 183 participants completed the survey (average age 48.5; 70.0% women: a 92.9%response rate. While 38.8% of physicians claimed that generics were worse than brand name drugs, 54.1% considered them to be better. However, 36.5% of the doctors did not choose generics for their own use. Two key opinions were identified among the responses concerning the effectiveness of generic drugs: use of generic drugs by the physician (p<0.001, and their opinion that pharmacists do inform patients about generic drugs (p<0.05. Although existing evidence confirms that generic and brand name drugs are equally effective, many physicians doubt this, which prevents them from being used as cost effective drug therapy. In order to increase healthcare savings through the use of generics, these factors should be addressed: for example, convincing a physician to adopt generics for personal use may be an efficient way to support more cost effective treatment of his patients.

76 FR 21800 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Generic...

Science.gov (United States)

2011-04-18

... precision requirements or power calculations that justify the proposed sample size, the expected response... Activities: Submission for OMB Review; Comment Request; Generic Clearance for the Collection of Qualitative... Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service...

International experiences of promoting generics use and its implications to China.

Science.gov (United States)

Sun, Jing

2013-05-01

To summarize international experiences in promoting use of generics and to extract essence for China's reference. This is a commentary of two systematic reviews about policies to promote use of generics and its implications to China. Price, reimbursement, and generic substitution policies in European countries, and approaches in low and middle income countries in promoting market competition, appropriate intellectual property right protection strategy, and necessary demand side incentives, are all meaningful for China to contain soaring pharmaceutical expenditures, and to maintain the achievements and outcomes of the national health system reform. Effective promotion of generics use must be practice based on the real situation. Tailor-made and comprehensive measures are needed to address both demand and supply sides barriers before achieving tangible cost containment effect without unexpected side effects. © 2013 Wiley Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

Lack of efficacy during the switch from brand to generic allopurinol.

Science.gov (United States)

De Vuono, Antonio; Scicchitano, Francesca; Palleria, Caterina; Russo, Emilio; De Sarro, Giovambattista; Gallelli, Luca

2013-07-01

We report for the first time the lack of therapeutic effects after the switch from a brand formulation of allopurinol to a generic one. A 56-year-old man, with a 5 years history of well-treated gout arthropathy with allopurinol (Zyloric(®) 300 mg/die), developed acute gout arthropathy after the switch from the brand formulation of allopurinol to a generic one. Clinical evaluation and laboratory findings confirmed the diagnosis of acute gout arthropathy. Generic formulation of the drug was dismissed and Zyloric(®) was administered with an improvement of both clinical symptoms and laboratory findings. In conclusion, even if generic formulations are considered to have the same effects in comparison to the brand one, more data are necessaries in order to well define their effectiveness and rationale use. Copyright © 2013 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

Methodology applied in Cuba for siting, designing, and building a radioactive waste repository under safety conditions

International Nuclear Information System (INIS)

Orbera, L.; Peralta, J.L.; Franklin, R.; Gil, R.; Chales, G.; Rodriguez, A.

1993-01-01

The work presents the methodology used in Cuba for siting, designing, and building a radioactive waste repository safely. This methodology covers both the technical and socio-economic factors, as well as those of design and construction so as to have a safe siting for this kind of repository under Cuba especial condition. Applying this methodology will results in a safe repository

The role of waste package specifications as a forerunner to ILW repository conditions for acceptance

International Nuclear Information System (INIS)

Barlow, S.V.; Palmer, J.D.

1998-01-01

In the absence of a finalized repository site, design or associated safety case, Nirex is not in a position to issue conditions for acceptance. Nirex has therefore developed a strategy which facilitates packaging of intermediate level waste by providing guidance through waste package specifications, supported by the formal assessment of specific packaging proposals on a case-by-case basis. The waste package specifications are comprehensive and cover all aspects of the waste package including dimensions and other key features, performance standards, wasteform, quality assurance, and data recording requirements. The waste package specifications will be subject to periodic review as repository design and safety cases are finalized and will progressively become site- and design-specific. The waste package specifications will eventually form the basis for conditions for acceptance. The strategy described in this paper has been successfully followed by Nirex and customers for the past ten years and has permitted wastes to be packaged for a deep repository with confidence in the absence of a finalized site and safety cases for the repository. Because the process has its basis in a generic repository concept, it remains robust, despite the increased uncertainty following the March 1997 Secretary of State's decision, as to the siting and time-scale of a deep waste repository, and continues to be an important component of the UK's waste management strategy. (author)

A new generic system for the pantropical Caesalpinia group (Leguminosae

Directory of Open Access Journals (Sweden)

Edeline Gagnon

2016-10-01

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

GenMed 010: a one day workshop on generic medicines

Directory of Open Access Journals (Sweden)

Shankar PR

2011-03-01

Full Text Available This report outlines the content of a one-day workshop onGeneric Medicines that was held at KIST Medical College,Lalitpur, Nepal on 13th December 2010, which was attendedby 32 delegates from different institutions in Nepal, includingpharmacists, pharmacologists and medical doctors. Rightmedicine, right patient, right dose, right frequency andduration, right information and right monitoring areconditions to be fulfilled for the rational use of medicine(RUM. The World Health Organization (WHO defines genericmedicine as ‘a pharmaceutical product, usually intended to beinterchangeable with the innovator product, marketed afterthe expiry of patent or other exclusivity rights’. Economicfactors, supportive legislation and regulation, public andprofessional acceptance and quality assurance are keyenabling factors promoting use of generics. Increased patentprotection for medicines and removing process patents is akey feature of new trade agreements and newer medicines fordiseases like HIV/AIDS, tuberculosis and infectious diseasesare likely to be more expensive. The Medicine andTherapeutics Committee (MTC can play a key role inpromoting generic medicine use in institutions.Nepal being among the Least Developed Countries (LDCsneed not provide patent protection for medicines until 31stDecember 2015. Only a few ‘true’ generics are available inNepal and there is huge cost variation in the price of differentbranded generics. Clinicians have concerns about the qualityof medicines in general, substitution of poor quality brands bypharmacists and about therapeutic substitution. Genericshave to meet the same regulatory requirements and bebioequivalent to reference preparations assuring their quality.

Site investigations for final disposal of high-level nuclear waste

International Nuclear Information System (INIS)

Aeikaes, T.; Laine, T.

1982-12-01

Research concerning disposal of high-level nuclear waste of the Industrial Power Company Ltd has focused on deep underground disposal in Finnish precambrian bedrock. The present target is to have a repository for high-level waste in operation by 2020. Selection of the repository site is based on site investigations. In addition to geosciences, selection of appropriate site includes many branches of studies; engineering, safety analysis, ecology, transport, demography etc. The investigations required for site selection for high-level waste have been arranged in a sequence of four phases. The aim of the phases is that investigations become more and more detailed as the selection process continues. Phase I of the investigations is the characterization of potential areas. This comprises establishment of criteria for site selection and identification of areas that meet selection criteria. Objective of these studies is to determine areas for phase II field investigations. The studies are largely made by reviewing existing data and remote-sensing techniques. Phase II field investigations will be undertaken between 1986-1992. The number of potential candidates for repository site is reduced to few preferred areas by preceeding generic study. The site selection process culminates in phase III in site confirmation studies carried out at 2...3 most suitable sites during 1992-2010. This is then followed by phase IV, which comprises very detailed investigations at the selected site. An alternative for these investigations is to undertake them by using pilot shaft and drifts. Active development is taking place in all phases concerning investigation methods, criteria, parameters, data processing and modelling. The applicability of the various investigation methods and techniques is tested in a deep borehole in phase I. The co-operation with countries with similar geological conditions makes it possible to compare results obtained by different techniques

Generic component failure data base

International Nuclear Information System (INIS)

Eide, S.A.; Calley, M.B.

1992-01-01

This report discusses comprehensive component generic failure data base which has been developed for light water reactor probabilistic risk assessments. The Nuclear Computerized Library for Assessing Reactor Reliability (NUCLARR) was used to generate component failure rates. Using this approach, most of the failure rates are based on actual plant data rather then existing estimates

Charcoal kiln sites, associated landscape attributes and historic forest conditions: DTM-based investigations in Hesse (Germany

Directory of Open Access Journals (Sweden)

Marcus Schmidt

2016-03-01

Full Text Available Background An examination of the distribution of ancient charcoal kiln sites in the forest landscape seems to be worthwhile, since general trends in the selection of suitable kiln site locations in the past might become obvious. In this way forest landscape elements with a more intense usage by charcoal burning can be identified. By doing this, we can expect to gain information on the former condition and tree species composition of woodland. Investigations on the spatial distribution of charcoal kiln sites in relation to landscape attributes are sparse, however, probably due to the high on-site mapping effort. The outstanding suitability of LiDAR-derived digital terrain models (DTMs for the detection of charcoal kiln sites has been recently proved. Hence, DTM-based surveys of charcoal kiln sites represent a promising attempt to fill this research gap. Methods Based on DTM-based surveys, we analyzed the spatial distribution of charcoal kiln sites in two forest landscapes in the German federal state of Hesse: Reinhardswald and Kellerwald-Edersee National Park. In doing so, we considered the landscape attibutes "tree species composition", “water supply status”, “nutrient supply status”, “soil complex classes”, “altitude”, “exposition”, and “inclination”. Results We found that charcoal kiln sites were established preferably on hillside locations that provided optimal growing and regeneration conditions for European beech (Fagus sylvatica due to their acidic brown soils and sufficient water supply. These results are in line with instructions for the selection of appropriate kiln site locations, found in literature from the 18th to the 19th century. Conclusions We conclude that there were well-stocked, beech-dominated deciduous forest stands in northern Hesse before 1800, particularly at poorly accessible hillside locations. These large stocks of beech wood were utilized by the governments of the different Hessian territories

Extension algorithm for generic low-voltage networks

Science.gov (United States)

Marwitz, S.; Olk, C.

2018-02-01

Distributed energy resources (DERs) are increasingly penetrating the energy system which is driven by climate and sustainability goals. These technologies are mostly connected to low- voltage electrical networks and change the demand and supply situation in these networks. This can cause critical network states. Network topologies vary significantly and depend on several conditions including geography, historical development, network design or number of network connections. In the past, only some of these aspects were taken into account when estimating the network investment needs for Germany on the low-voltage level. Typically, fixed network topologies are examined or a Monte Carlo approach is used to quantify the investment needs at this voltage level. Recent research has revealed that DERs differ substantially between rural, suburban and urban regions. The low-voltage network topologies have different design concepts in these regions, so that different network topologies have to be considered when assessing the need for network extensions and investments due to DERs. An extension algorithm is needed to calculate network extensions and investment needs for the different typologies of generic low-voltage networks. We therefore present a new algorithm, which is capable of calculating the extension for generic low-voltage networks of any given topology based on voltage range deviations and thermal overloads. The algorithm requires information about line and cable lengths, their topology and the network state only. We test the algorithm on a radial, a loop, and a heavily meshed network. Here we show that the algorithm functions for electrical networks with these topologies. We found that the algorithm is able to extend different networks efficiently by placing cables between network nodes. The main value of the algorithm is that it does not require any information about routes for additional cables or positions for additional substations when it comes to estimating

Origami building blocks: Generic and special four-vertices

Science.gov (United States)

Waitukaitis, Scott; van Hecke, Martin

2016-02-01

Four rigid panels connected by hinges that meet at a point form a four-vertex, the fundamental building block of origami metamaterials. Most materials designed so far are based on the same four-vertex geometry, and little is known regarding how different geometries affect folding behavior. Here we systematically categorize and analyze the geometries and resulting folding motions of Euclidean four-vertices. Comparing the relative sizes of sector angles, we identify three types of generic vertices and two accompanying subtypes. We determine which folds can fully close and the possible mountain-valley assignments. Next, we consider what occurs when sector angles or sums thereof are set equal, which results in 16 special vertex types. One of these, flat-foldable vertices, has been studied extensively, but we show that a wide variety of qualitatively different folding motions exist for the other 15 special and 3 generic types. Our work establishes a straightforward set of rules for understanding the folding motion of both generic and special four-vertices and serves as a roadmap for designing origami metamaterials.

Generic safety documentation model

International Nuclear Information System (INIS)

Mahn, J.A.

1994-04-01

This document is intended to be a resource for preparers of safety documentation for Sandia National Laboratories, New Mexico facilities. It provides standardized discussions of some topics that are generic to most, if not all, Sandia/NM facilities safety documents. The material provides a ''core'' upon which to develop facility-specific safety documentation. The use of the information in this document will reduce the cost of safety document preparation and improve consistency of information

Value-impact assessment for resolution of generic safety issue 143 - availability of HVAC and chilled water systems

Energy Technology Data Exchange (ETDEWEB)

Daling, P.M.; Marler, J.E.; Vo, T.V. [Pacific Northwest Laboratory, Richland, WA (United States)] [and others

1995-02-01

The Pacific Northwest Laboratory (PNL), under contract to the U.S. Nuclear Regulatory Commission (NRC), has conducted an assessment of the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue 143, {open_quotes}Availability of Heating, Ventilation, and Air Conditioning (HVAC) and Chilled Water Systems.{close_quotes} This assessment was conducted to identify vulnerabilities related to failure of HVAC, chilled water and room cooling systems and develop estimates of the core damage frequencies and public risks associated with failures of these systems. This information was used to develop proposed resolution strategies to this generic issue and perform a value/impact assessment to determine their cost-effectiveness. Probabilistic risk assessments (PRAs) for four representative plants from the basis for the core damage frequency and public risk calculations. Internally-initiated core damage sequences as well as external events were considered. Three proposed resolution strategies were developed for this safety issue and it was determined that all three were not cost-effective. Additional evaluations were performed to develop {open_quotes}generic{close_quotes} insights on potential design-related vulnerabilities and potential high-frequency accident sequences that involve failures of HVAC/room cooling functions.

Proposal of organisation and ALARA procedures for maintenance site: application to replacement of steam generator

International Nuclear Information System (INIS)

Lochard, J.; Lefaure, C.

1989-08-01

This report proposes generic organization and ALARA procedures for preparing a maintenance site at a NPP. After a short description of the ALARA principle, it describes the proposition for French sites. They are grouped according to the following: motivation, organisation, means. They are illustrated by the example of steam generator replacement. Three special points concerning preparation of the site are developed: education; training of operators; review of the project

Place-based social contact and mixing: a typology of generic meeting places of relevance for infectious disease transmission.

Science.gov (United States)

Strömgren, M; Holm, E; Dahlström, Ö; Ekberg, J; Eriksson, H; Spreco, A; Timpka, T

2017-09-01

This study aims to develop a typology of generic meeting places based on social contact and mixing of relevance for infectious disease transmission. Data were collected by means of a contact diary survey conducted on a representative sample of the Swedish population. The typology is derived from a cluster analysis accounting for four dimensions associated with transmission risk: visit propensity and its characteristics in terms of duration, number of other persons present and likelihood of physical contact. In the analysis, we also study demographic, socio-economic and geographical differences in the propensity of visiting meeting places. The typology identifies the family venue, the fixed activity site, the family vehicle, the trading plaza and the social network hub as generic meeting places. The meeting place typology represents a spatially explicit account of social contact and mixing relevant to infectious disease modelling, where the social context of the outbreak can be highlighted in light of the actual infectious disease.

Radiation analysis for a generic centralized interim storage facility

International Nuclear Information System (INIS)

Gillespie, S.G.; Lopez, P.; Eble, R.G.

1997-01-01

This paper documents the radiation analysis performed for the storage area of a generic Centralized Interim Storage Facility (CISF) for commercial spent nuclear fuel (SNF). The purpose of the analysis is to establish the CISF Protected Area and Restricted Area boundaries by modeling a representative SNF storage array, calculating the radiation dose at selected locations outside the storage area, and comparing the results with regulatory radiation dose limits. The particular challenge for this analysis is to adequately model a large (6000 cask) storage array with a reasonable amount of analysis time and effort. Previous analyses of SNF storage systems for Independent Spent Fuel Storage Installations at nuclear plant sites (for example in References 5.1 and 5.2) had only considered small arrays of storage casks. For such analyses, the dose contribution from each storage cask can be modeled individually. Since the large number of casks in the CISF storage array make such an approach unrealistic, a simplified model is required

Generic patches containing fentanyl: In vitro equivalence and abuse deterrent evaluation according to EMA and FDA guidelines.

Science.gov (United States)

Padula, Cristina; Pescina, Silvia; Nicoli, Sara; Santi, Patrizia

2018-02-15

The aim of this work was to characterize in vitro and ex vivo the performances of Durogesic and of two bioequivalent generic products, by evaluating: (a) fentanyl release; (b) fentanyl permeation across porcine skin and (c) fentanyl ease of extraction. Additional characteristics studied are the effect of temperature and skin integrity, applied individually or combined, to check a possible synergism. The two generic patches resulted equivalent to the originator according to the new Guideline. Nevertheless, the same data reported in a different way, i.e. considering the total amount of drug permeated from the whole patch over the application time, highlight differences among the patches. The additional tests performed showed that skin integrity does not represent a barrier for fentanyl permeation across the skin, regardless of the type and complexity of the patch. The effect of temperature resulted critical for two out of three patches, probably due to the different composition and to the different structure. The combination of skin damage and elevated temperature did not produce a synergistic effect. Fentanyl extraction was different for the different products and variable according to the conditions used. The results reported in the present work underline the influence of patch composition and complexity on fentanyl extraction, release and skin permeation, in particular in conditions that can be critical, such as elevated temperature. In particular, the effect of critical variables, such as skin integrity and temperature, should be addressed to in the development of a new or new generic patch and new discriminant tests should be developed. Copyright © 2017 Elsevier B.V. All rights reserved.

Protective actions as a factor in power reactor siting

Energy Technology Data Exchange (ETDEWEB)

Gant, K.S.; Schweitzer, M.

1984-06-01

This report examines the relationship between a power reactor site and the ease of implementing protective actions (emergency measures a serious accident). Limiting populating density around a reactor lowers the number of people at risk but cannot assure that all protective actions are possible for those who reside near the reactor. While some protective measures can always be taken (i.e., expedient respiratory protection, sheltering) the ability to evacuate the area or find adequate shelter may depend on the characteristics of the area near the reactor site. Generic siting restrictions designed to identify and eliminate these site-specific constraints would be difficult to formulate. The authors suggest identifying possible impediments to protective actions at a proposed reactor site and addressing these problems in the emergency plans. 66 references, 6 figures, 8 tables.

Protective actions as a factor in power reactor siting

International Nuclear Information System (INIS)

Gant, K.S.; Schweitzer, M.

1984-06-01

This report examines the relationship between a power reactor site and the ease of implementing protective actions (emergency measures a serious accident). Limiting populating density around a reactor lowers the number of people at risk but cannot assure that all protective actions are possible for those who reside near the reactor. While some protective measures can always be taken (i.e., expedient respiratory protection, sheltering) the ability to evacuate the area or find adequate shelter may depend on the characteristics of the area near the reactor site. Generic siting restrictions designed to identify and eliminate these site-specific constraints would be difficult to formulate. The authors suggest identifying possible impediments to protective actions at a proposed reactor site and addressing these problems in the emergency plans. 66 references, 6 figures, 8 tables

Site-conditions map for Portugal based on VS measurements: methodology and final model

Science.gov (United States)

Vilanova, Susana; Narciso, João; Carvalho, João; Lopes, Isabel; Quinta Ferreira, Mario; Moura, Rui; Borges, José; Nemser, Eliza; Pinto, carlos

2017-04-01

In this paper we present a statistically significant site-condition model for Portugal based on shear-wave velocity (VS) data and surface geology. We also evaluate the performance of commonly used Vs30 proxies based on exogenous data and analyze the implications of using those proxies for calculating site amplification in seismic hazard assessment. The dataset contains 161 Vs profiles acquired in Portugal in the context of research projects, technical reports, academic thesis and academic papers. The methodologies involved in characterizing the Vs structure at the sites in the database include seismic refraction, multichannel analysis of seismic waves and refraction microtremor. Invasive measurements were performed in selected locations in order to compare the Vs profiles obtained from both invasive and non-invasive techniques. In general there was good agreement in the subsurface structure of Vs30 obtained from the different methodologies. The database flat-file includes information on Vs30, surface geology at 1:50.000 and 1:500.000 scales, elevation and topographic slope and based on SRTM30 topographic dataset. The procedure used to develop the site-conditions map is based on a three-step process that includes defining a preliminary set of geological units based on the literature, performing statistical tests to assess whether or not the differences in the distributions of Vs30 are statistically significant, and merging of the geological units accordingly. The dataset was, to some extent, affected by clustering and/or preferential sampling and therefore a declustering algorithm was applied. The final model includes three geological units: 1) Igneous, metamorphic and old (Paleogene and Mesozoic) sedimentary rocks; 2) Neogene and Pleistocene formations, and 3) Holocene formations. The evaluation of proxies indicates that although geological analogues and topographic slope are in general unbiased, the latter shows significant bias for particular geological units and

Development of generic soil profiles and soil data development for SSI analyses

Energy Technology Data Exchange (ETDEWEB)

Parker, Josh, E-mail: jparker@nuscalepower.com [NuScale Power, 1000 NE Circle Boulevard, Suite 10310, Corvallis, OR 97330 (United States); Khan, Mohsin; Rajagopal, Raj [ARES Corporation, 1990N California Boulevard, Suite 500, Walnut Creek, CA 94596 (United States); Groome, John [NuScale Power, 1000 NE Circle Boulevard, Suite 10310, Corvallis, OR 97330 (United States)

2014-04-01

This paper presents the approach to developing generic soil profiles for the design of reactor building for small modular reactor (SMR) nuclear power plant developed by NuScale Power. The reactor building is a deeply embedded structure. In order to perform soil structure interaction (SSI) analyses, generic soil profiles are required to be defined for the standardized Nuclear Power Plant (NPP) designs for the United States Nuclear Regulatory Commission (NRC) in a design control document (DCD). The development of generic soil profiles is based on utilization of information on generic soil profiles from the new standardized nuclear power plant designs already submitted to the NRC for license certification. Eleven generic soil profiles have been recommended, and those profiles cover a wide range of parameters such as soil depth, shear wave velocity, unit weight, Poisson's ratio, water table, and depth to rock strata. The soil profiles are developed for a range of shear wave velocities between bounds of 1000 fps and 8000 fps as inferred from NRC Standard Review Plan (NUREG 0800) Sections 3.7.1 and 3.7.2. To account for the soil degradation due to seismic events, the strain compatible soil properties are based on the EPRI generic soil degradation curves. In addition, one dimensional soil dynamic response analyses were performed to study the soil layer input motions for performing the SSI analyses.

Adherence and persistence with branded antidepressants and generic SSRIs among managed care patients with major depressive disorder

Directory of Open Access Journals (Sweden)

Xianchen Liu

2011-03-01

Full Text Available Xianchen Liu1,2, Yi Chen3, Douglas E Faries31Former employee, Eli Lilly and Company, Indianapolis, Indiana, USA; 2Indiana University Department of Psychiatry, Indianapolis, Indiana, USA; 3Eli Lilly and Company, Indianapolis, Indiana, USAObjective: This study compared adherence and persistence of three branded antidepressants: the serotonin and norepinephrine reuptake inhibitors (SNRIs duloxetine and venlafaxine XR, and the selective serotonin reuptake inhibitor (SSRI escitalopram; and generic selective SSRIs, and examined demographic and clinical predictors of adherence and persistence in patients with major depressive disorder in usual care settings.Method: A total of 44,026 patients (18 to 64 years from a large commercial administrative claims database were classified as initiators of duloxetine (n = 7,567, venlafaxine XR (n = 6,106, escitalopram (n = 10,239, or generic SSRIs (n = 20,114 during 2006. Adherence was defined as the medication possession ratio of ≥ 0.8 and persistence as the length of therapy without exceeding a 15-day gap. Pairwise comparisons from multivariate logistic regression and Cox proportional hazards models were performed to examine predictors of adherence and persistence.Results: Adherence rate after one year was significantly higher in duloxetine recipients (38.1% than patients treated with venlafaxine XR (34.0%, escitalopram (25.4%, or generic SSRIs (25.5% (all P < 0.01. Duloxetine recipients stayed on medication longer (158.5 days than those receiving venlafaxine XR (149.6 days, escitalopram (129.1 days, or generic SSRIs (130.2 days (all P < 0.001. Compared with patients treated with escitalopram or generic SSRIs, venlafaxine XR recipients had better adherence and longer persistence (P < 0.001. In addition, being aged 36 years or more, hypersomnia, anxiety disorders, and prior use of antidepressants were associated with increased adherence and persistence, while the opposite was true for comorbid chronic pain

REMINDER - Compliance with Operational Circular No. 2 on conditions of access to the fenced CERN sites

CERN Multimedia

Relations with the Host States Service

2004-01-01

The purpose of Operational Circular No. 2 is to contribute to the protection of people and property by defining the conditions of access to the Organization's fenced sites. However, recently, the services concerned have noted a significant increase in the instances of non-compliance with those conditions that cannot be tolerated, for example: use of CERN access cards by people, other than the cardholders themselves, in order to gain access to facilities without having attended the required safety course; speeding, particularly on Route Gregory and Route Weisskopf; driving in and out of the site on the wrong side of the road; parking on spaces set aside for the disabled; nuisance parking, especially in the proximity of the Restaurants; the dumping of wrecked vehicles. As the aforementioned instances of non-compliance can lead to dangerous situations, the Organization reserves the right to apply the penalties provided for under paragraph 26 of Operational Circular No. 2, namely to refuse access to the site ...

Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets.

Science.gov (United States)

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

2015-07-06

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

Generic patch inference

DEFF Research Database (Denmark)

Andersen, Jesper; Lawall, Julia

2010-01-01

A key issue in maintaining Linux device drivers is the need to keep them up to date with respect to evolutions in Linux internal libraries. Currently, there is little tool support for performing and documenting such changes. In this paper we present a tool, spdiff, that identifies common changes...... developers can use it to extract an abstract representation of the set of changes that others have made. Our experiments on recent changes in Linux show that the inferred generic patches are more concise than the corresponding patches found in commits to the Linux source tree while being safe with respect...

Spectral unmixing of urban land cover using a generic library approach

Science.gov (United States)

Degerickx, Jeroen; Lordache, Marian-Daniel; Okujeni, Akpona; Hermy, Martin; van der Linden, Sebastian; Somers, Ben

2016-10-01

Remote sensing based land cover classification in urban areas generally requires the use of subpixel classification algorithms to take into account the high spatial heterogeneity. These spectral unmixing techniques often rely on spectral libraries, i.e. collections of pure material spectra (endmembers, EM), which ideally cover the large EM variability typically present in urban scenes. Despite the advent of several (semi-) automated EM detection algorithms, the collection of such image-specific libraries remains a tedious and time-consuming task. As an alternative, we suggest the use of a generic urban EM library, containing material spectra under varying conditions, acquired from different locations and sensors. This approach requires an efficient EM selection technique, capable of only selecting those spectra relevant for a specific image. In this paper, we evaluate and compare the potential of different existing library pruning algorithms (Iterative Endmember Selection and MUSIC) using simulated hyperspectral (APEX) data of the Brussels metropolitan area. In addition, we develop a new hybrid EM selection method which is shown to be highly efficient in dealing with both imagespecific and generic libraries, subsequently yielding more robust land cover classification results compared to existing methods. Future research will include further optimization of the proposed algorithm and additional tests on both simulated and real hyperspectral data.

Climate Change: Generic Implications for Agriculture

Indian Academy of Sciences (India)

Climate Change: Generic Implications for Agriculture. Increasing carbon dioxide: Good for most crops. Increase in mean temperature: orter ... Increasing rainfall intensity and dry days- more floods and droughts: Higher production variability. Himalayan glaciers to recede: irrigation in IGP gradually becomes less dependable ...

Uncertainty analyses of infiltration and subsurface flow and transport for SDMP sites

International Nuclear Information System (INIS)

Meyer, P.D.; Rockhold, M.L.; Gee, G.W.

1997-09-01

US Nuclear Regulatory Commission staff have identified a number of sites requiring special attention in the decommissioning process because of elevated levels of radioactive contaminants. Traits common to many of these sites include limited data characterizing the subsurface, the presence of long-lived radionuclides necessitating a long-term analysis (1,000 years or more), and potential exposure through multiple pathways. As a consequence of these traits, the uncertainty in predicted exposures can be significant. In addition, simplifications to the physical system and the transport mechanisms are often necessary to reduce the computational requirements of the analysis. Several multiple-pathway transport codes exist for estimating dose, two of which were used in this study. These two codes have built-in Monte Carlo simulation capabilities that were used for the uncertainty analysis. Several tools for improving uncertainty analyses of exposure estimates through the groundwater pathway have been developed and are discussed in this report. Generic probability distributions for unsaturated and saturated zone soil hydraulic parameters are presented. A method is presented to combine the generic distributions with site-specific water retention data using a Bayesian analysis. The resulting updated soil hydraulic parameter distributions can be used to obtain an updated estimate of the probability distribution of dose. The method is illustrated using a hypothetical decommissioning site

Implementation of IEC Generic Model Type 1 Wind Turbine Generators using RTDS

DEFF Research Database (Denmark)

Cha, Seung-Tae; Wu, Qiuwei; Zhao, Haoran

With the ever increasing penetration of the wind power generation, transmission system operators (TSOs) and distribution system operators (DSOs) are demanding an accurate dynamic wind turbine generator (WTG) models for power system stability studies. However, the confidential requirements from wind...... are useful tools to evaluate the impact of the wind power on the power system stability. Thus, a strong stimulus exists for the development of a generic dynamic model in order to further investigate the dynamic response of WTG under grid disturbances. This paper presents the implementation of the IEC generic...... turbine manufacturers prevent the academia and researchers from working on a real or/and manufacturer specific models. A generic WTG model is of great interest that does not contain the confidential information meanwhile represents the manufacturer specific models. These generic dynamic simulation models...

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

Science.gov (United States)

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

2017-12-28

Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine. This study was a cross-sectional observational study employing a self-administered questionnaire. The questionnaire was of four main sections: demographic and practice details of the participants, knowledge, attitudes and the influencing factors related to selection and dispensing of generic medicines. A convenience sampling technique was implemented in this study in which the data collection form was distributed in West Bank- Palestine among a set of practicing pharmacists. Mann-Whitney-U or Kruskal-Wallis tests were used to comparison of different issues as appropriate. P-values of marketing approval of generics, while 87.4% of participants agreed that they should be given the right to substitute generics and the majority (62.3%) support generic substitution for brand name drugs in all cases when a generic is available The main two factors affect pharmacists' selection and dispensing of generic medicines are personal faith in the product (86.1%) and cost effectiveness of generic medicines (84.1%). Generic medicines substitution among pharmacists is widespread and prevalent. Our data found that participant pharmacists in Palestine had basic knowledge with regards to generic medicine. However, their knowledge score pertaining the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters in particular was insufficient.

A proposal for generic competence assessment in a serious game

Directory of Open Access Journals (Sweden)

María José Bezanilla

2014-01-01

Full Text Available This paper focuses on the design of a serious game for the teaching and assessment of generic competences, placing particular emphasis on the competences assessment aspect. Taking into account important aspects of competence assessment such as context, feedback and transparency, among other aspects, and using the University of Deusto's Generic Competences Assessment Model based on the defining of levels, indicators and descriptors as a reference point, a serious game has been designed for the development and evaluation of two Generic Competences: Problem Solving and Entrepreneurship, aimed at final-year undergraduate and first-year postgraduate students. The design process shows that having a Competence Assessment Model based on levels, indicators and descriptors is of great help in defining the game's scenarios and learning and assessment activities. Serious games can also be excellent resources to help in the development and assessment of generic competences, but not as a unique tool, since the concept of competence in itself is highly complex (integrating knowledge, skills, attitudes and values and some elements might require other methods and techniques for its development. It also reveals the difficulties of evaluating competences in general and through serious games in particular.

40 CFR 721.5452 - Alkali metal salt of halogenated organoborate (generic).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkali metal salt of halogenated... Specific Chemical Substances § 721.5452 Alkali metal salt of halogenated organoborate (generic). (a... generically as alkali metal salt of halogenated organoborate (PMN P-00-0638) is subject to reporting under...

Generic drugs: myths, facts, and limitations

Directory of Open Access Journals (Sweden)

Antonio Marzo

2012-10-01

Full Text Available Bioequivalence (BE has always been an important pharmaceutical area, particularly (but not solely in Mediterranean region, where the use of generic drugs is a relatively recent development. The lack of new therapeutic molecules has concentrated primary research in the hands of a few large pharmaceutical companies. For smaller companies, this has created opportunities for the development of new formulations of existing drugs (orodispersible tablets that dissolve in the mouth, extended-release tablets, transdermal delivery systems, generic drugs. These applications take advantage of the Abridged New Drug Application (ANDA procedure, which exempts them from a series of expensive investigations and limits the requirement for clinical testing to bioequivalence trials. Since 1991, bioequivalence trials have been regulated by US Food and Drug Administration (FDA and European Medicines Agency (EMA guidelines that provide precise indications on the most specific procedures to be adopted. In spite of these guidelines, however, some aspects of the process have not been fully defined, the most important of which regards the management of endogenous substances. Additional problems are how to manage bioequivalence protocols with drugs that have long half-lives and those whose clearance is characterized by high intrinsic variability. The view that bioequivalence data would be more reliable if they were based on studies in target populations is a myth to be discredited. The present paper reviews issues relative to pharmacokinetics (PK, bioavailability (BA, and bioequivalence, also from an historical viewpoint, and includes a stimulating “questions and answers” section on some key aspects of the bioequivalence of generic drugs.

Communication across 300 generations: deterring human interference with waste deposit sites

International Nuclear Information System (INIS)

Tannenbaum, P.H.

1984-04-01

The conditions attendant on the deep land burial of nuclear waste products raise a number of possible scenarios to cover the necessary 10,000 years of burial. However, no matter what kind of futuristic scenario obtains, it is desirable to develop an information system indicating the locale and nature of the deposit site and the types of materials stored, along with forewarnings not to interefere with the sites. A variety of such informational sites are suggested. Attention then turns to the recipients of such messages, recognizing from the outset that the psychological/perceptual makeup of individuals across the next 300 or so generations is virtually impossible to predict, particularly since new technologies may well alter that makeup in the furture. Nevertheless, current evidence suggests that certain human characteristics may be considered universal, and that these suggest the incorporation of selected sign signification into the message system. There are other such characteristics that, while probably not intrinsic, can probably be acquired with a minimum of formal training. That still leaves much of the message content to be deliberately created and, hence, learned. The common trefoil or other developed biohazardous signs emerge as the best candidates for a generic base symbol for the buried material

Communication across 300 generations: deterring human interference with waste deposit sites

Energy Technology Data Exchange (ETDEWEB)

Tannenbaum, P.H.

1984-04-01

The conditions attendant on the deep land burial of nuclear waste products raise a number of possible scenarios to cover the necessary 10,000 years of burial. However, no matter what kind of futuristic scenario obtains, it is desirable to develop an information system indicating the locale and nature of the deposit site and the types of materials stored, along with forewarnings not to interefere with the sites. A variety of such informational sites are suggested. Attention then turns to the recipients of such messages, recognizing from the outset that the psychological/perceptual makeup of individuals across the next 300 or so generations is virtually impossible to predict, particularly since new technologies may well alter that makeup in the furture. Nevertheless, current evidence suggests that certain human characteristics may be considered universal, and that these suggest the incorporation of selected sign signification into the message system. There are other such characteristics that, while probably not intrinsic, can probably be acquired with a minimum of formal training. That still leaves much of the message content to be deliberately created and, hence, learned. The common trefoil or other developed biohazardous signs emerge as the best candidates for a generic base symbol for the buried material.

Molecularly Imprinted Polymer Technology: A Powerful, Generic ...

African Journals Online (AJOL)

Molecularly Imprinted Polymer Technology: A Powerful, Generic, Facile and Cost Effective Alternative for Enantio-recognition and Separation: A Glance at Advances and Applications. ... Tanzania Journal of Science. Journal Home · ABOUT ...

Impacts of Generic Competition and Benefit Management...

Data.gov (United States)

U.S. Department of Health & Human Services — According to findings reported in Impacts of Generic Competition and Benefit Management Practices on Spending for Prescription Drugs - Evidence from Medicares Part D...

Use of site specific data from Aespoe - preliminary results from the on-going safety analysis SR 97

International Nuclear Information System (INIS)

Stroem, A.; Selroos, J.O.; Andersson, Johan

1998-01-01

This paper discusses an on-going safety assessment study of SKB as well as the use of field data from Aespoe for obtaining input parameters for flow and radionuclide transport modelling in the geosphere. In the on-going Safety Assessment study SR 97, three individual sites in Sweden are used for exemplifying site specific conditions on overall repository performance. Thus, models capable of reproducing site specific characteristics are utilised. This is primarily obtained by implementing the geologic structural models in suitable conceptual models for groundwater flow on both regional and local scales. The models for flow incorporate observed and/or inferred water conducting features as well as other site-specific characteristics necessary for realistic descriptions of flow at the sites. The flow modelling thus aims at realism; the results obtained for present day conditions should not in any serious aspect conflict with observations at the site. Agreement between observed and modelled entities provides confidence in that a sound understanding of the site is obtained. Aespoe is one of the three sites providing site-specific conditions in SR 97. Transport is subsequently modelled using a stream tube approach where the 'travel times', for non-sorbing species, and discharge locations of a set of one-dimensional stream tubes are obtained from particle tracking in the flow model. The resulting distribution of 'travel times' in a single model realisation reflects the spatial variability and spatial extent of the repository, whereas the ensemble travel time distribution (over several realisations) for a given canister location reflects the uncertainty in travel time. The actual transport paths used in the transport modelling are thus dependent on site specific information such as e.g. existence of water conductive features. Other input parameters to the transport model are based on more generic and/or conservative arguments. However, the goal in a safety assessment

Building generic anatomical models using virtual model cutting and iterative registration

Directory of Open Access Journals (Sweden)

Hallgrímsson Benedikt

2010-02-01

Full Text Available Abstract Background 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. Methods 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. Results 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. Conclusions Our method is very flexible and easy to use such that anyone can use image stacks to create models and

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

Science.gov (United States)

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

2014-01-01

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

Generic model of a community-based microgrid integrating wind turbines, photovoltaics and CHP generations

International Nuclear Information System (INIS)

Ma, Xiandong; Wang, Yifei; Qin, Jianrong

2013-01-01

Highlights: ► Proposes a generic microgrid model comprising hybrid distributed generation units. ► Examines DG performance due to both environmental condition changes and electrical faults. ► Addresses island and grid connected modes of operation for DG units. ► We demonstrate the feasibility of the proposed residential microgrid system. - Abstract: Development and deployment of low-carbon energy technologies has been a national strategy of both the UK and China for a number of years, including the use of renewable generation technologies and the improvement of energy efficiency of operations and activities. The paper addresses several issues of generic importance to a residential microgrid system such as network modelling, advanced control and integration of intelligent monitoring techniques. The system, comprising representative distributed generation technologies of photovoltaics, wind turbines and combined heat and power, has been simulated by PSCAD/EMTDC under different operational scenarios. Studies include the effect of environmental condition changes, control systems and power electronics on wind turbines and PV cells, and the mixture of wind/solar/CHP energy generation under dominance of each technology. The performance and dynamics of the system are examined against symmetrical and asymmetrical electrical faults to seek an optimal isolation and restoration of the distributed generation unit from the connected grid system. Modelling these system interactions has demonstrated the feasibility of the proposed residential microgrid system

Is There Evidence to Support Brand to Generic Interchange of the Mycophenolic Acid Products?

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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.

HIV/AIDS drugs for Sub-Saharan Africa: how do brand and generic supply compare?

Directory of Open Access Journals (Sweden)

Colleen V Chien

Full Text Available BACKGROUND: Significant quantities of antiretroviral drugs (ARVs to treat HIV/AIDS have been procured for Sub-Saharan Africa for the first time in their 20-year history. This presents a novel opportunity to empirically study the roles of brand and generic suppliers in providing access to ARVs. METHODOLOGY/PRINCIPAL FINDINGS: An observational study of brand and generic supply based on a dataset of 2,162 orders of AIDS drugs for Sub-Saharan Africa reported to the Global Price Reporting Mechanism at the World Health Organization from January 2004-March 2006 was performed. Generic companies supplied 63% of the drugs studied, at prices that were on average about a third of the prices charged by brand companies. 96% of the procurement was of first line drugs, which were provided mostly by generic firms, while the remaining 4%, of second line drugs, was sourced primarily from brand companies. 85% of the generic drugs in the sample were manufactured in India, where the majority of the drugs procured were ineligible for patent protection. The remaining 15% was manufactured in South Africa, mostly under voluntary licenses provided by brand companies to a single generic company. In Sub-Saharan African countries, four first line drugs in the dataset were widely patented, however no general deterrent to generic purchasing based on a patent was detected. CONCLUSIONS/SIGNIFICANCE: Generic and brand companies have played distinct roles in increasing the availability of ARVs in Sub-Saharan Africa. Generic companies provided most of the drugs studied, at prices below those charged by brand companies, and until now, almost exclusively supplied several fixed-dose combination drugs. Brand companies have supplied almost all second line drugs, signed voluntary licenses with generic companies, and are not strictly enforcing patents in certain countries. Further investigation into how price reductions in second line drugs can be achieved and the cheapest drugs can

Evaluation of biofidelity of THUMS pedestrian model under a whole-body impact conditions with a generic sedan buck.

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Wu, Taotao; Kim, Taewung; Bollapragada, Varun; Poulard, David; Chen, Huipeng; Panzer, Matthew B; Forman, Jason L; Crandall, Jeff R; Pipkorn, Bengt

2017-05-29

The goal of this study was to evaluate the biofidelity of the Total Human Model for Safety (THUMS; Ver. 4.01) pedestrian finite element models (PFEM) in a whole-body pedestrian impact condition using a well-characterized generic pedestrian buck model. The biofidelity of THUMS PFEM was evaluated with respect to data from 3 full-scale postmortem human subject (PMHS) pedestrian impact tests, in which a pedestrian buck laterally struck the subjects using a pedestrian buck at 40 km/h. The pedestrian model was scaled to match the anthropometry of the target subjects and then positioned to match the pre-impact postures of the target subjects based on the 3-dimensional motion tracking data obtained during the experiments. An objective rating method was employed to quantitatively evaluate the correlation between the responses of the models and the PMHS. Injuries in the models were predicted both probabilistically and deterministically using empirical injury risk functions and strain measures, respectively, and compared with those of the target PMHS. In general, the model exhibited biofidelic kinematic responses (in the Y-Z plane) regarding trajectories (International Organization for Standardization [ISO] ratings: Y = 0.90 ± 0.11, Z = 0.89 ± 0.09), linear resultant velocities (ISO ratings: 0.83 ± 0.07), accelerations (ISO ratings: Y = 0.58 ± 0.11, Z = 0.52 ± 0.12), and angular velocities (ISO ratings: X = 0.48 ± 0.13) but exhibited stiffer leg responses and delayed head responses compared to those of the PMHS. This indicates potential biofidelity issues with the PFEM for regions below the knee and in the neck. The model also demonstrated comparable reaction forces at the buck front-end regions to those from the PMHS tests. The PFEM generally predicted the injuries that the PMHS sustained but overestimated injuries in the ankle and leg regions. Based on the data considered, the THUMS PFEM was considered to be biofidelic for this pedestrian impact condition and vehicle

Design of generic coal conversion facilities: Process release---Direct coal liquefaction

Energy Technology Data Exchange (ETDEWEB)

1991-09-01

The direct liquefaction portion of the PETC generic direct coal liquefaction process development unit (PDU) is being designed to provide maximum operating flexibility. The PDU design will permit catalytic and non-catalytic liquefaction concepts to be investigated at their proof-of-the-concept stages before any larger scale operations are attempted. The principal variations from concept to concept are reactor configurations and types. These include thermal reactor, ebullating bed reactor, slurry phase reactor and fixed bed reactor, as well as different types of catalyst. All of these operating modes are necessary to define and identify the optimum process conditions and configurations for determining improved economical liquefaction technology.

A method to generate generic floor response spectra for operating nuclear power plants

International Nuclear Information System (INIS)

Curreri, J.; Costantino, C.; Subudhi, M.; Reich, M.

1985-01-01

A free-field earthquake response spectra was used to generate horizontal earthquake time histories. The excitation was applied through the soil and into the various structures to produce responses in equipment. An entire range of soil conditions was used with each structure, from soft soil to solid rock. Actual PWR and BWR - Mark I structural models were used as representative of a class of structures. For each model, the stiffness properties were varied, with the same mass, so as to extend the fundamental base structure natural frequency from 2 cps to 36 cps. This resulted in fundamental mode coupled natural frequencies as low as 0.86 cps and as high as 30 cps. From all of these models of soils and structures, floor response spectra were generated at each floor level. The natural frequencies of the structures were varied to obtain maximum response conditions. The actual properties were first used to locate the natural frequencies. The stiffness properties were than varied, with the same mass, to extend the range of the fundamental base structure natural frequency. The intention was to have the coupled structural material frequencies in the vicinity of the peak amplitude frequency content of the excitation spectrum. Particular attention was therefore given to the frequency band between 2 Hz and 4 Hz. A horizontal generic floor response spectra is proposed for the top level of a generic structure. Reduction factors are applied to the peak acceleration for equipment at lower levels. (orig./HP)

Comparison of Compounded, Generic, and Innovator-Formulated Itraconazole in Dogs and Cats.

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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 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.

Generic programming for deterministic neutron transport codes

International Nuclear Information System (INIS)

Plagne, L.; Poncot, A.

2005-01-01

This paper discusses the implementation of neutron transport codes via generic programming techniques. Two different Boltzmann equation approximations have been implemented, namely the Sn and SPn methods. This implementation experiment shows that generic programming allows us to improve maintainability and readability of source codes with no performance penalties compared to classical approaches. In the present implementation, matrices and vectors as well as linear algebra algorithms are treated separately from the rest of source code and gathered in a tool library called 'Generic Linear Algebra Solver System' (GLASS). Such a code architecture, based on a linear algebra library, allows us to separate the three different scientific fields involved in transport codes design: numerical analysis, reactor physics and computer science. Our library handles matrices with optional storage policies and thus applies both to Sn code, where the matrix elements are computed on the fly, and to SPn code where stored matrices are used. Thus, using GLASS allows us to share a large fraction of source code between Sn and SPn implementations. Moreover, the GLASS high level of abstraction allows the writing of numerical algorithms in a form which is very close to their textbook descriptions. Hence the GLASS algorithms collection, disconnected from computer science considerations (e.g. storage policy), is very easy to read, to maintain and to extend. (authors)

Comments on ''Use of conditional simulation in nuclear waste site performance assessment'' by Carol Gotway

International Nuclear Information System (INIS)

Downing, D.J.

1993-01-01

This paper discusses Carol Gotway's paper, ''The Use of Conditional Simulation in Nuclear Waste Site Performance Assessment.'' The paper centers on the use of conditional simulation and the use of geostatistical methods to simulate an entire field of values for subsequent use in a complex computer model. The issues of sampling designs for geostatistics, semivariogram estimation and anisotropy, turning bands method for random field generation, and estimation of the comulative distribution function are brought out

Generic Advertising Optimum Budget for Iran’s Milk Industry

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H. Shahbazi

2016-05-01

Full Text Available Introduction One of the main targets of planners, decision makers and governments is increasing society health with promotion and production of suitable and healthy food. One of the basic commodities that have important role in satisfaction of required human food is milk. So, some part of government and producer healthy budget allocate to milk consumption promotion by using generic advertising. If effectiveness of advertising budget on profitability is more, producer will have more willing to spend for advertising. Determination of optimal generic advertising budget is one of important problem in managerial decision making in producing firm as well as increase in consumption and profit and decrease in wasting and non-optimality of budget. Materials and Methods: In this study, optimal generic advertising budget intensity index (advertising budget share of production cost was estimated under two different scenarios by using equilibrium replacement model. In equilibrium replacement model, producer surplus are maximized in respect to generic advertising in retail level. According to market where two levels of farm and processing before retail exist and there is trade in farm and retail level, we present different models. Fixed and variable proportion hypothesis is another one. Finally, eight relations are presented for determination of milk generic advertising optimum budget. So, we use data from several resources such as previous studies, national (Iran Static center and international institute (Fao formal data and own estimation. Because there are several estimations in previous studies, we identify some scenarios (in two general scenarios for calculation of milk generic advertising optimum budget. Results and Discussion: Estimation of milk generic advertising optimum budget in scenario 1 shows that in case of one market level, fixed supplies and no trade, optimum budget is 0.4672539 percent. In case of one market level and no trade, optimum

Generic Principles for Resolving Intergroup Conflict.

Science.gov (United States)

Fisher, Ronald J.

1994-01-01

Provides an initial statement of generic principles deemed effective for addressing protracted social conflicts between identity groups. These principles are compatible with certain values for societal organization and approaches to social change, raising questions of value differences between intervenors and the host culture(s). Three case…

Binary mixtures of condensates in generic confining potentials

Energy Technology Data Exchange (ETDEWEB)

Facchi, P [Dipartimento di Matematica and MECENAS, Universita di Bari, I-70125 Bari (Italy); Florio, G; Pascazio, S; Pepe, F V, E-mail: Francesco.Pepe@ba.infn.it [INFN, Sezione di Bari, I-70126 Bari (Italy)

2011-12-16

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. (paper)

Binary mixtures of condensates in generic confining potentials