Measuring health-related quality of life in children with cancer living in Mainland China: feasibility, reliability and validity of the Chinese Mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module.

PubMed

Ji, Yi; Chen, Siyuan; Li, Kai; Xiao, Nong; Yang, Xue; Zheng, Shan; Xiao, Xianmin

2011-11-23

The Pediatric Quality of Life Inventory (PedsQL) is widely used instrument to measure pediatric health-related quality of life (HRQOL) for children aged 2 to 18 years. The purpose of the current study was to investigate the feasibility, reliability and validity of the Chinese mandarin version of the PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module in a group of Chinese children with cancer. The PedsQL 4.0 Genetic Core Scales and the PedsQL 3.0 Cancer Module were administered to children with cancer (aged 5-18 years) and parents of such children (aged 2-18 years). For comparison, a survey on a demographically group-matched sample of the general population with children (aged 5-18) and parents of children (aged 2-18 years) was conducted with the PedsQL 4.0 Genetic Core Scales. The minimal mean percentage of missing item responses (except the School Functioning scale) supported the feasibility of the PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module for Chinese children with cancer. Most of the scales showed satisfactory reliability with Cronbach's α of exceeding 0.70, and all scales demonstrated sufficient test-retest reliability. Assessing the clinical validity of the questionnaires, statistically significant difference was found between healthy children and children with cancer, and between children on-treatment versus off-treatment ≥12 months. Positive significant correlations were observed between the scores of the PedsQL 4.0 Generic Core Scale and the PedsQL 3.0 Cancer Module. Exploratory factor analysis demonstrated sufficient factorial validity. Moderate to good agreement was found between child self- and parent proxy-reports. The findings support the feasibility, reliability and validity of the Chinese Mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module in children with cancer living in mainland China.

Measuring health-related quality of life in children with cancer living in mainland China: feasibility, reliability and validity of the Chinese mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module

PubMed Central

2011-01-01

Background The Pediatric Quality of Life Inventory (PedsQL) is widely used instrument to measure pediatric health-related quality of life (HRQOL) for children aged 2 to 18 years. The purpose of the current study was to investigate the feasibility, reliability and validity of the Chinese mandarin version of the PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module in a group of Chinese children with cancer. Methods The PedsQL 4.0 Genetic Core Scales and the PedsQL 3.0 Cancer Module were administered to children with cancer (aged 5-18 years) and parents of such children (aged 2-18 years). For comparison, a survey on a demographically group-matched sample of the general population with children (aged 5-18) and parents of children (aged 2-18 years) was conducted with the PedsQL 4.0 Genetic Core Scales. Result The minimal mean percentage of missing item responses (except the School Functioning scale) supported the feasibility of the PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module for Chinese children with cancer. Most of the scales showed satisfactory reliability with Cronbach's α of exceeding 0.70, and all scales demonstrated sufficient test-retest reliability. Assessing the clinical validity of the questionnaires, statistically significant difference was found between healthy children and children with cancer, and between children on-treatment versus off-treatment ≥12 months. Positive significant correlations were observed between the scores of the PedsQL 4.0 Generic Core Scale and the PedsQL 3.0 Cancer Module. Exploratory factor analysis demonstrated sufficient factorial validity. Moderate to good agreement was found between child self- and parent proxy-reports. Conclusion The findings support the feasibility, reliability and validity of the Chinese Mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module in children with cancer living in mainland China. PMID:22111968

Patient-reported Pediatric Quality of Life Inventory™ 4.0 Generic Core Scales in pediatric patients with attention-deficit/hyperactivity disorder and comorbid psychiatric disorders: feasibility, reliability, and validity.

PubMed

Limbers, Christine A; Ripperger-Suhler, Jane; Heffer, Robert W; Varni, James W

2011-06-01

The primary objective of the study was to evaluate the feasibility, reliability, and validity of the Pediatric Quality of Life Inventory™ (PedsQL) 4.0 Generic Core Scales as a patient self-reported health-related quality of life measurement instrument in pediatric patients with attention-deficit/hyperactivity disorder (ADHD) and physician-diagnosed comorbid psychiatric disorders being seen in a pediatric psychiatric clinic. The secondary objective was to evaluate parent proxy-reported PedsQL in this population. One hundred seventy-nine children with ADHD and comorbid psychiatric disorders ages 5 to 18 years and 181 parents completed the PedsQL 4.0 Generic Core Scales and parents also completed the Vanderbilt ADHD Diagnostic Rating Scales. Known-groups discriminant validity comparisons were made between the sample of pediatric patients with ADHD and comorbid psychiatric disorders and healthy, cancer, and type 1 diabetes samples. The PedsQL evidenced minimal missing responses for patient self-report and parent proxy-report (0.2% and 0.5%, respectively), demonstrated no significant floor or ceiling effects, and achieved excellent reliability for the Total Scale Score (α = 0.85 patient self-report, 0.92 parent proxy-report). Pediatric patients with ADHD and comorbid psychiatric disorders and their parents reported statistically significantly worse PedsQL scores than healthy children, with large effect sizes across all domains, supporting known-groups discriminant validity. Pediatric patients with ADHD and comorbid psychiatric disorders and their parents reported worse PedsQL scores compared to pediatric patients with cancer and diabetes with the exception of physical health, in which pediatric cancer patients manifested lower physical health, indicating the relative severe impact of ADHD and comorbid psychiatric disorders. More severe ADHD symptoms were generally associated with more impaired PedsQL scores, supporting construct validity. These data demonstrate the

Using Rasch rating scale model to reassess the psychometric properties of the Persian version of the PedsQLTM 4.0 Generic Core Scales in school children

PubMed Central

2012-01-01

Background Item response theory (IRT) is extensively used to develop adaptive instruments of health-related quality of life (HRQoL). However, each IRT model has its own function to estimate item and category parameters, and hence different results may be found using the same response categories with different IRT models. The present study used the Rasch rating scale model (RSM) to examine and reassess the psychometric properties of the Persian version of the PedsQLTM 4.0 Generic Core Scales. Methods The PedsQLTM 4.0 Generic Core Scales was completed by 938 Iranian school children and their parents. Convergent, discriminant and construct validity of the instrument were assessed by classical test theory (CTT). The RSM was applied to investigate person and item reliability, item statistics and ordering of response categories. Results The CTT method showed that the scaling success rate for convergent and discriminant validity were 100% in all domains with the exception of physical health in the child self-report. Moreover, confirmatory factor analysis supported a four-factor model similar to its original version. The RSM showed that 22 out of 23 items had acceptable infit and outfit statistics (<1.4, >0.6), person reliabilities were low, item reliabilities were high, and item difficulty ranged from -1.01 to 0.71 and -0.68 to 0.43 for child self-report and parent proxy-report, respectively. Also the RSM showed that successive response categories for all items were not located in the expected order. Conclusions This study revealed that, in all domains, the five response categories did not perform adequately. It is not known whether this problem is a function of the meaning of the response choices in the Persian language or an artifact of a mostly healthy population that did not use the full range of the response categories. The response categories should be evaluated in further validation studies, especially in large samples of chronically ill patients. PMID:22414135

Using Rasch rating scale model to reassess the psychometric properties of the Persian version of the PedsQL™ 4.0 Generic Core Scales in school children.

PubMed

Jafari, Peyman; Bagheri, Zahra; Ayatollahi, Seyyed Mohamad Taghi; Soltani, Zahra

2012-03-13

Item response theory (IRT) is extensively used to develop adaptive instruments of health-related quality of life (HRQoL). However, each IRT model has its own function to estimate item and category parameters, and hence different results may be found using the same response categories with different IRT models. The present study used the Rasch rating scale model (RSM) to examine and reassess the psychometric properties of the Persian version of the PedsQL™ 4.0 Generic Core Scales. The PedsQL™ 4.0 Generic Core Scales was completed by 938 Iranian school children and their parents. Convergent, discriminant and construct validity of the instrument were assessed by classical test theory (CTT). The RSM was applied to investigate person and item reliability, item statistics and ordering of response categories. The CTT method showed that the scaling success rate for convergent and discriminant validity were 100% in all domains with the exception of physical health in the child self-report. Moreover, confirmatory factor analysis supported a four-factor model similar to its original version. The RSM showed that 22 out of 23 items had acceptable infit and outfit statistics (<1.4, >0.6), person reliabilities were low, item reliabilities were high, and item difficulty ranged from -1.01 to 0.71 and -0.68 to 0.43 for child self-report and parent proxy-report, respectively. Also the RSM showed that successive response categories for all items were not located in the expected order. This study revealed that, in all domains, the five response categories did not perform adequately. It is not known whether this problem is a function of the meaning of the response choices in the Persian language or an artifact of a mostly healthy population that did not use the full range of the response categories. The response categories should be evaluated in further validation studies, especially in large samples of chronically ill patients.

Health related quality of life assessment in Pakistani paediatric cancer patients using PedsQL™ 4.0 generic core scale and PedsQL™ cancer module.

PubMed

Chaudhry, Zainab; Siddiqui, Salma

2012-05-18

The purpose of the study was to evaluate and compare the HRQOL of paediatric cancer in comparison to the healthy children across age groups, using PedsQLTM 4.0 Generic Core Scales and the PedsQL™ Cancer Module. The PedsQLTM 4.0 Generic Core Scales and PedsQL Cancer Module 3.0 were administered on 56 children including 26 cancer patients and 30 healthy children while employing self and proxy report forms. Furthermore, the results were compared with their healthy comparison group. The results indicated a significant relationship between HRQOL reports of cancer patients and their parents. However, the mean of paediatric cancer patients is significantly lower as compare to their healthy comparison group. The mean of proxy report is lower overall on both PedsQL and PedsQL cancer module reports. Conclusively, overall HRQOL of cancer patients was lower than healthy children but it is quite similar to their parents' perception. Whereas, the parental mean on PedsQL and PedsQL 3.0 Cancer Module are significantly low. The study indicated a marked difference between cancer patients and healthy children's HRQOL perception and unfortunately in country like Pakistan where cancer is on increase, no significant work has yet been done to explore this area of research. The present study highlighted the need to focus on the particular psychological health services required to serve the physically challenged population.

Factorial invariance of child self-report across healthy and chronic health condition groups: a confirmatory factor analysis utilizing the PedsQLTM 4.0 Generic Core Scales.

PubMed

Limbers, Christine A; Newman, Daniel A; Varni, James W

2008-07-01

The objective of the present study was to examine the factorial invariance of the PedsQL 4.0 Generic Core Scales for child self-report across 11,433 children ages 5-18 with chronic health conditions and healthy children. Multigroup Confirmatory Factor Analysis was performed specifying a five-factor model. Two multigroup structural equation models, one with constrained parameters and the other with unconstrained parameters, were proposed in order to compare the factor loadings across children with chronic health conditions and healthy children. Metric invariance (i.e., equal factor loadings) was demonstrated based on stability of the Comparative Fit Index (CFI) between the two models, and several additional indices of practical fit including the root mean squared error of approximation, the Non-normed Fit Index, and the Parsimony Normed Fit Index. The findings support an equivalent five-factor structure on the PedsQL 4.0 Generic Core Scales across healthy and chronic health condition groups. These findings suggest that when differences are found across chronic health condition and healthy groups when utilizing the PedsQL, these differences are more likely real differences in self-perceived health-related quality of life, rather than differences in interpretation of the PedsQL items as a function of health status.

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

PubMed

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

2007-07-16

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

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

PubMed Central

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

2007-01-01

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

Reliability and validity of the Iranian version of the Pediatric Quality of Life Inventory™ 4.0 Generic Core Scales in adolescents.

PubMed

Amiri, Parisa; M Ardekani, Emad; Jalali-Farahani, Sara; Hosseinpanah, Farhad; Varni, James W; Ghofranipour, Fazlollah; Montazeri, Ali; Azizi, Fereidoun

2010-12-01

The objective of this study was to investigate the reliability and validity of the Iranian version of the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ 4.0) Generic Core Scales in adolescents After linguistic validation, the Iranian version of the PedsQL™ 4.0 was completed by 848 healthy and 26 chronically ill adolescents aged 13-18 years and their parents. The internal consistency as measured by Cronbach's alpha coefficients exceeded the minimum reliability standard of .70. No floor effects were observed. Ceiling effects detected ranged from 1.5% for adolescent self-report total scale score to 42.2% for self-report social functioning. All monotrait-multimethod correlations were higher than multitrait-multimethod correlations. The intraclass correlation coefficients (ICC) between adolescent self-report and parent proxy-report showed good to excellent agreement. Exploratory factor analysis supported mainly comparable results with the original US English dialect version. The results of the confirmatory factor analysis for 5-factor models for both self-report and proxy-report indicated acceptable fit for the proposed models. Regarding gender and health status, as hypothesized from previous studies, girls reported lower health-related quality of life than boys on the total score, physical and emotional functioning, and healthy adolescents reported significantly higher health-related quality of life than those with chronic illnesses. The findings support the initial reliability and validity of the Iranian version of the PedsQL™ 4.0 as a generic instrument to measure HRQOL of adolescents in Iran.

Validation of modified forms of the PedsQL generic core scales and cancer module scales for adolescents and young adults (AYA) with cancer or a blood disorder.

PubMed

Ewing, Jane E; King, Madeleine T; Smith, Narelle F

2009-03-01

To validate two health-related quality of life (HRQOL) measures, the PedsQL Generic Core and Cancer Module adolescent forms (13-18 years), after modification for 16-25-year-old adolescents and young adults (AYA) with cancer or a blood disorder. AYA patients and nominated proxies were recruited from three Sydney hospitals. Modified forms were administered by telephone or in clinics/wards. Analyses included correlations, factor analysis, and analysis of variance of known-groups (defined by the Memorial Symptom Assessment Scale). Eighty-eight patients and 79 proxies completed questionnaires. Factor structures consistent with those of the unmodified forms confirmed construct validity. Cronbach's alpha ranged 0.81-0.98. Inter-scale correlations were as hypothesized, confirming discriminant validity. Statistically significant differences between groups with mild, moderate, and severe symptoms (P < 0.05) confirmed clinical validity. These modified forms provide reliable and valid measures of HRQOL in AYA with cancer or a blood disorder, suitable for clinical trials, research, and practice.

PedsQLTM 4.0 Generic Core Scales for adolescents in the Yoruba language: translation and general psychometric properties.

PubMed

Atilola, Olayinka; Stevanović, Dejan

2014-04-01

Quality of life (QOL) is a universally accepted concept for measuring the impact of different aspects of life on general well-being. Adaptation of existing QOL instruments to local cultures has been identified as a better strategy than development of new ones. To translate and adapt the Paediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales (PedsQL™) to the Yoruba language and culture and to test the psychometric properties of the adapted instrument among adolescents. Psychometric properties including internal consistency reliability, construct and factorial validity of the Yoruba version of PedsQL™ were evaluated using standard procedures. The self report and proxy scales of the Yoruba PedsQL™ were developed with good cultural relevance and semantic/conceptual equivalence. Results from 527 adolescents revealed a Cronbach's coefficient which exceeded 0.7 for internal consistency reliability for all scores. The healthy subjects reported higher PedsQL™ scores than those with mental health and physical problems, which confirmed construct validity. Confirmatory factor analysis revealed a good model fit for the Psychosocial Health score, but not for the other measures. The Yoruba PedsQL™ is culturally appropriate and with good internal consistency, reliability and construct validity. More work is needed regarding its factorial validity.

Some psychometric properties of the Pediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales (PedsQL™) in the general Serbian population.

PubMed

Stevanović, Dejan; Lakić, Aneta; Damnjanović, Maja

2011-08-01

The aim of this study was to evaluate the general measurement properties of the Serbian version of the Pediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales (PedsQL™) self-report versions for children and adolescents (8-18 years). The PedsQL™ was completed by 238 children and adolescents. The version was descriptively analyzed first. Afterward, internal consistency and construct and convergent validity were analyzed using the classic test theory psychometrical procedures. The PedsQL™ scale score means ranged 70.65-88.34, with the total score was 80.74. Scale internal consistency reliability determined by Cronbach's coefficient was above 0.7 for all except the School, 0.65, and Emotional Functioning Scale, 0.69. The statistics assessing the adequacy of the model in confirmatory factor analysis revealed poor model fit for the current structure of the PedsQL™. Finally, the PedsQL™ total and psychosocial health showed convincing negative correlations with emotional and conduct problems, hyperactivity/inattention, and peer relationship problems. The Serbian PedsQL™ scales have appropriate internal consistency reliability, sufficient for group evaluations, and good convergent validity against psychological constructs. However, there are problems regarding its current construct validity (factorial validity).

Factorial invariance of child self-report across age subgroups: a confirmatory factor analysis of ages 5 to 16 years utilizing the PedsQL 4.0 Generic Core Scales.

PubMed

Limbers, Christine A; Newman, Daniel A; Varni, James W

2008-01-01

The utilization of health-related quality of life (HRQOL) measurement in an effort to improve pediatric health and well-being and determine the value of health care services has grown dramatically over the past decade. The paradigm shift toward patient-reported outcomes (PROs) in clinical trials has provided the opportunity to emphasize the value and essential need for pediatric patient self-report. In order for HRQOL/PRO comparisons to be meaningful for subgroup analyses, it is essential to demonstrate factorial invariance. This study examined age subgroup factorial invariance of child self-report for ages 5 to 16 years on more than 8,500 children utilizing the PedsQL 4.0 Generic Core Scales. Multigroup Confirmatory Factor Analysis (MGCFA) was performed specifying a five-factor model. Two multigroup structural equation models, one with constrained parameters and the other with unconstrained parameters, were proposed to compare the factor loadings across the age subgroups. Metric invariance (i.e., equal factor loadings) across the age subgroups was demonstrated based on stability of the Comparative Fit Index between the two models, and several additional indices of practical fit including the Root Mean Squared Error of Approximation, the Non-Normed Fit Index, and the Parsimony Normed Fit Index. The findings support an equivalent five-factor structure across the age subgroups. Based on these data, it can be concluded that children across the age subgroups in this study interpreted items on the PedsQL 4.0 Generic Core Scales in a similar manner regardless of their age.

Psychometric properties of the Chinese version of the Pediatric Quality of Life Inventory 4.0 generic core scales.

PubMed

Hao, Yuantao; Tian, Qi; Lu, Yiyun; Chai, Yiming; Rao, Shaoqi

2010-10-01

The aim of this study was to evaluate the psychometric properties of the Chinese version of the Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) generic core scales. The standard procedure of cross-culture adaptation was used to develop the Chinese version PedsQL4.0. We enrolled 1583 healthy children and 1335 pediatric patients (aged from 5 to 18 years) and 325 proxies. The psychometric properties of the measure were evaluated. The subscales of physical functioning, social functioning and psychosocial showed alpha coefficients above 0.7 for self-report in healthy children and the total pediatric patients, and all coefficients were higher than 0.7 for proxy report for all subscales. There were higher correlations between items and hypothesized subscales than with other subscales. Healthy children reported higher scores than pediatric patients in all subscales. Confirmatory factor analysis showed that some of the indices of goodness of fit did not reach the standard of acceptable construct validity. Moderate to high correlations were found between self-reported and proxy-reported scores. The Chinese version PedsQL4.0 has acceptable psychometric properties except the construct validity tested by confirmatory factor analysis and the internal reliability for self-report in pediatric patients with migraine or Gilles and Tourette's syndrome.

Health-related quality of life in young adult patients with rheumatoid arthritis in Iran: reliability and validity of the Persian translation of the PedsQL™ 4.0 Generic Core Scales Young Adult Version.

PubMed

Pakpour, Amir H; Zeidi, Isa Mohammadi; Hashemi, Fariba; Saffari, Mohsen; Burri, Andrea

2013-01-01

The objective of the present study was to determine the reliability and validity of the Persian translation of the Pediatric Quality of Life Inventory (PedsQL™) 4.0 Generic Core Scales Young Adult Version in an Iranian sample of young adult patients with rheumatoid arthritis (RA). One hundred ninety-seven young adult patients with RA completed the 23-item PedsQL™ and the 36-item Short-Form Health Survey (SF-36). Disease activity based on Disease Activity Score 28 was also measured. Internal consistency and test-retest reliability, as well as construct, discriminant, and convergent validity, were tested. Confirmatory factor analysis (CFA) was used to verify the original factor structure of the PedsQL™. Also, responsiveness to change in PedsQL™ scores over time was assessed. Cronbach's alpha coefficients ranged from α = 0.82 to α = 0.91. Test-retest reproducibility was satisfactory for all scales and the total scale score. The PedsQL proved good convergent validity with the SF-36. The PedsQL distinguished well between young adult patients and healthy young adults and also RA groups with different comorbidities. The CFA did not confirm the original four-factor model, instead, analyses revealed a best-fitting five-factor model for the PedsQL™ Young Adult Version. Repeated measures analysis of variance indicated that the PedsQL scale scores for young adults increased significantly over time. The Persian translation of the PedsQL™ 4.0 Generic Core Scales Young Adult Version demonstrated good psychometric properties in young adult patients with RA and can be recommended for the use in RA research in Iran.

Measuring health-related quality of life in young adolescents: reliability and validity in the Norwegian version of the Pediatric Quality of Life Inventory 4.0 (PedsQL) generic core scales.

PubMed

Reinfjell, Trude; Diseth, Trond H; Veenstra, Marijke; Vikan, Arne

2006-09-14

Health-Related Quality of Life (HRQOL) studies concerning children and adolescents are a growing field of research. The Pediatric Quality of Life Inventory (PedsQL) is considered as a promising HRQOL instrument with the availability of age appropriate versions and parallel forms for both child and parents. The purpose of the current study was to evaluate the psychometric properties of the Norwegian translation of the Pediatric Quality of Life Inventory (PedsQL) 4.0 generic core scale in a sample of healthy young adolescents. A cross-sectional study of 425 healthy young adolescents and 237 of their caregivers participating as a proxy. Reliability was assessed by Cronbach's alpha. Construct validity was assessed using exploratory factor analysis and by exploring the intercorrelations between and among the four PedsQL subscales for adolescents and their parents. All the self-report scales and proxy-report scales showed satisfactory reliability with Cronbach's alpha varying between 0.77 and 0.88. Factor analysis showed results comparable with the original version, except for the Physical Health scale. On average, monotrait-multimethod correlations were higher than multitrait-multimethod correlations. Sex differences were noted on the emotional functioning subscale, girls reported lower HRQOL than boys. The Norwegian PedsQL is a valid and reliable generic pediatric health-related Quality of Life measurement that can be recommended for self-reports and proxy-reports for children in the age groups ranging from 13-15 years.

Health-Related Quality of Life of Nepalese Children With Leukemia Using Pediatric Quality of Life Inventory 4.0 Generic Core Scale.

PubMed

V K, Anu; Onta, Mandira; Joshi, Sarala

Health-related quality of life (HRQOL) is an essential measure to consider when evaluating the full impact of illness in children diagnosed with leukemia. The purpose of the current study was to assess the overall HRQOL and specific functioning subscales of Nepalese children with leukemia using Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0), compare self-report with parent proxy report of HRQOL and to identify the determinants affecting HRQOL. After cultural linguistic validation of PedsQL, a descriptive cross-sectional study was conducted on 43 children with leukemia and their parents in B. P. Koirala Memorial Cancer Hospital, Bharatpur via interview schedule. Among the subscales of HRQOL both the child's self-report and parent proxy report scores were highest in social functioning and lowest in emotional functioning subscale. Intraclass correlation coefficient between proxy reports and self-reports were highest (0.828) in physical functioning and lowest (0.493) in social functioning subscales. Age group was significantly associated with the total score, physical functioning subscale, and emotional functioning subscale of only proxy scores. Leukemic children's age-specific needs should be addressed properly to improve their overall HRQOL.

Measuring Belief in Conspiracy Theories: The Generic Conspiracist Beliefs Scale

PubMed Central

Brotherton, Robert; French, Christopher C.; Pickering, Alan D.

2013-01-01

The psychology of conspiracy theory beliefs is not yet well understood, although research indicates that there are stable individual differences in conspiracist ideation – individuals’ general tendency to engage with conspiracy theories. Researchers have created several short self-report measures of conspiracist ideation. These measures largely consist of items referring to an assortment of prominent conspiracy theories regarding specific real-world events. However, these instruments have not been psychometrically validated, and this assessment approach suffers from practical and theoretical limitations. Therefore, we present the Generic Conspiracist Beliefs (GCB) scale: a novel measure of individual differences in generic conspiracist ideation. The scale was developed and validated across four studies. In Study 1, exploratory factor analysis of a novel 75-item measure of non-event-based conspiracist beliefs identified five conspiracist facets. The 15-item GCB scale was developed to sample from each of these themes. Studies 2, 3, and 4 examined the structure and validity of the GCB, demonstrating internal reliability, content, criterion-related, convergent and discriminant validity, and good test-retest reliability. In sum, this research indicates that the GCB is a psychometrically sound and practically useful measure of conspiracist ideation, and the findings add to our theoretical understanding of conspiracist ideation as a monological belief system unpinned by a relatively small number of generic assumptions about the typicality of conspiratorial activity in the world. PMID:23734136

External validity of a generic safety climate scale for lone workers across different industries and companies.

PubMed

Lee, Jin; Huang, Yueng-hsiang; Robertson, Michelle M; Murphy, Lauren A; Garabet, Angela; Chang, Wen-Ruey

2014-02-01

The goal of this study was to examine the external validity of a 12-item generic safety climate scale for lone workers in order to evaluate the appropriateness of generalized use of the scale in the measurement of safety climate across various lone work settings. External validity evidence was established by investigating the measurement equivalence (ME) across different industries and companies. Confirmatory factor analysis (CFA)-based and item response theory (IRT)-based perspectives were adopted to examine the ME of the generic safety climate scale for lone workers across 11 companies from the trucking, electrical utility, and cable television industries. Fairly strong evidence of ME was observed for both organization- and group-level generic safety climate sub-scales. Although significant invariance was observed in the item intercepts across the different lone work settings, absolute model fit indices remained satisfactory in the most robust step of CFA-based ME testing. IRT-based ME testing identified only one differentially functioning item from the organization-level generic safety climate sub-scale, but its impact was minimal and strong ME was supported. The generic safety climate scale for lone workers reported good external validity and supported the presence of a common feature of safety climate among lone workers. The scale can be used as an effective safety evaluation tool in various lone work situations. Copyright © 2013 Elsevier Ltd. All rights reserved.

How young can children reliably and validly self-report their health-related quality of life?: an analysis of 8,591 children across age subgroups with the PedsQL 4.0 Generic Core Scales.

PubMed

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

2007-01-03

The last decade has evidenced a dramatic increase in the development and utilization of pediatric health-related quality of life (HRQOL) measures in an effort to improve pediatric patient health and well-being and determine the value of healthcare services. The emerging paradigm shift toward patient-reported outcomes (PROs) in clinical trials has provided the opportunity to further emphasize the value and essential need for pediatric patient self-reported outcomes measurement. Data from the PedsQL DatabaseSM were utilized to test the hypothesis that children as young as 5 years of age can reliably and validly report their HRQOL. The sample analyzed represented child self-report age data on 8,591 children ages 5 to 16 years from the PedsQL 4.0 Generic Core Scales DatabaseSM. Participants were recruited from general pediatric clinics, subspecialty clinics, and hospitals in which children were being seen for well-child checks, mild acute illness, or chronic illness care (n = 2,603, 30.3%), and from a State Children's Health Insurance Program (SCHIP) in California (n = 5,988, 69.7%). Items on the PedsQL 4.0 Generic Core Scales had minimal missing responses for children as young as 5 years old, supporting feasibility. The majority of the child self-report scales across the age subgroups, including for children as young as 5 years, exceeded the minimum internal consistency reliability standard of 0.70 required for group comparisons, while the Total Scale Scores across the age subgroups approached or exceeded the reliability criterion of 0.90 recommended for analyzing individual patient scale scores. Construct validity was demonstrated utilizing the known groups approach. For each PedsQL scale and summary score, across age subgroups, including children as young as 5 years, healthy children demonstrated a statistically significant difference in HRQOL (better HRQOL) than children with a known chronic health condition, with most effect sizes in the medium to large effect

Health-related quality of life of Estonian adolescents: reliability and validity of the PedsQL™ 4.0 Generic Core Scales in Estonia.

PubMed

Viira, Roomet; Koka, Andre

2011-07-01

The main aim of this study was to examine the reliability and validity of the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ 4.0) Generic Core Scales among Estonian adolescents. Gender differences in health-related quality of life (HRQoL) were also investigated. The 654 adolescents (309 boys and 345 girls) aged 13-14 years (M age = 13.57 years, SD = 0.62) completed Estonian version of the PedsQL™ 4.0. Results of the confirmatory factor analysis for a five-factor model of the Estonian version of PedsQL™ 4.0 approached the criteria of acceptable fit after setting error covariance to be free between some of the items within physical health, emotional functioning and social functioning subscales. Cronbach's alpha coefficients exceeded the minimum criterion of 0.70 for all subscales except for days missed from school because of illness subscale. With regard to gender differences, consistent with previous studies, girls reported lower level on total score of HRQoL as well as its aspects of physical health, emotional functioning and psychosocial health. The present study revealed that after some modifications, the PedsQL™ 4.0 could be considered as suitable instrument to measure HRQoL among Estonian adolescents. © 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.

Construct Validity and Responsiveness of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales and Infant Scales in the PICU.

PubMed

Aspesberro, François; Fesinmeyer, Megan D; Zhou, Chuan; Zimmerman, Jerry J; Mangione-Smith, Rita

2016-06-01

To assess the construct validity and the responsiveness of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales and Infant Scales in the medical-surgical (PICU) and cardiac PICU. Prospective cohort study of 367 inpatients admitted either to the PICU or the cardiac ICU at Seattle Children's Hospital from January 2012 to June 2013. Parent/caregiver and child (≥ 8 yr old, developmentally appropriate, and critical illness resolved) Pediatric Quality of Life Inventory scores were obtained within 24 hours of PICU/cardiac ICU discharge and subsequently at 4-12 weeks following hospital discharge. Of the 491 eligible participants invited to participate, 367 (74.7% response rate) completed the Pediatric Quality of Life Inventory survey at ICU discharge, and of these, 263 (71.7% follow-up response rate) completed the follow-up survey 4-12 weeks after hospital discharge. Responsiveness was assessed by calculating improvement scores (difference between follow-up and ICU discharge scores, Δ Pediatric Quality of Life Inventory). Construct validity was examined by comparing mean improvement scores for known groups differing by medical complexity. At follow-up, [INCREMENT] Pediatric Quality of Life Inventory scores were as follows (mean ± SD): physical domain, 34.8 ± 32.0; and psychosocial domain, 23.1 ± 23.5. Patients with complex chronic or noncomplex chronic disease had physical functioning improvement scores that were 17.4 points (95% CI, -28.3 to -6.5; p < 0.001) and 19.5 points (95% CI, -30.4 to -8.5; p < 0.002) lower than children with no chronic illness, respectively. Patients with complex chronic disease exhibited psychosocial improvement scores that were 9.6 points (95% CI, -18.4 to -0.8; p < 0.033) lower than patients without chronic disease. Patients with noncomplex chronic disease had similar psychosocial improvement scores when compared with patients without chronic disease. As a measure of health-related quality of live, Pediatric Quality of

Health-related quality of life of youth with inflammatory bowel disease: a comparison with published data using the PedsQL 4.0 generic core scales.

PubMed

Kunz, Jennifer Hauser; Hommel, Kevin A; Greenley, Rachel Neff

2010-06-01

This study compared youth and parent-proxy reports of health-related quality of life (HRQoL) among youth with inflammatory bowel disease (IBD) to published comparison group data and examined concordance between youth and parent-proxy reports of HRQoL. One hundred thirty-six youth and parent-proxy reports on the PedsQL 4.0 Generic Core Scales were compared to published data from chronically ill, acutely ill, and healthy comparison groups using independent samples t-tests. Reporter agreement was examined using paired samples t-tests and intraclass correlations (ICCs). Youth with IBD reported lower psychosocial functioning than the healthy comparison group, higher physical and social functioning than the chronically ill group, and lower school functioning than all published comparison groups. Parent-proxy reports of youth HRQoL were higher than the chronically ill group, but lower than the healthy group on all scales except psychosocial functioning. Youth with active IBD reported lower physical health domain scores than youth with inactive disease. Concordance between youth and parent-proxy reports was moderate, with the lowest agreement in school and social functioning. Youth with IBD and their parents rate HRQoL as lower than healthy youth but do not perceive the impact of IBD to be as limiting as in other chronic conditions. Youth report suggests that IBD may be particularly detrimental to HRQoL in the school functioning domain. Moderate agreement between parent and youth reports substantiates continued use of multiple informants in studies of pediatric HRQoL.

Can manual ability be measured with a generic ABILHAND scale? A cross-sectional study conducted on six diagnostic groups

PubMed Central

Arnould, Carlyne; Vandervelde, Laure; Batcho, Charles Sèbiyo; Penta, Massimo; Thonnard, Jean-Louis

2012-01-01

Objectives Several ABILHAND Rasch-built manual ability scales were previously developed for chronic stroke (CS), cerebral palsy (CP), rheumatoid arthritis (RA), systemic sclerosis (SSc) and neuromuscular disorders (NMD). The present study aimed to explore the applicability of a generic manual ability scale unbiased by diagnosis and to study the nature of manual ability across diagnoses. Design Cross-sectional study. Setting Outpatient clinic homes (CS, CP, RA), specialised centres (CP), reference centres (CP, NMD) and university hospitals (SSc). Participants 762 patients from six diagnostic groups: 103 CS adults, 113 CP children, 112 RA adults, 156 SSc adults, 124 NMD children and 124 NMD adults. Primary and secondary outcome measures Manual ability as measured by the ABILHAND disease-specific questionnaires, diagnosis and nature (ie, uni-manual or bi-manual involvement and proximal or distal joints involvement) of the ABILHAND manual activities. Results The difficulties of most manual activities were diagnosis dependent. A principal component analysis highlighted that 57% of the variance in the item difficulty between diagnoses was explained by the symmetric or asymmetric nature of the disorders. A generic scale was constructed, from a metric point of view, with 11 items sharing a common difficulty among diagnoses and 41 items displaying a category-specific location (asymmetric: CS, CP; and symmetric: RA, SSc, NMD). This generic scale showed that CP and NMD children had significantly less manual ability than RA patients, who had significantly less manual ability than CS, SSc and NMD adults. However, the generic scale was less discriminative and responsive to small deficits than disease-specific instruments. Conclusions Our finding that most of the manual item difficulties were disease-dependent emphasises the danger of using generic scales without prior investigation of item invariance across diagnostic groups. Nevertheless, a generic manual ability scale could be

Health-related quality of life in young adults in education, employment, or training: development of the Japanese version of Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales Young Adult Version.

PubMed

Kaneko, Mei; Sato, Iori; Soejima, Takafumi; Kamibeppu, Kiyoko

2014-09-01

The purpose of the study is to develop a Japanese version of the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales Young Adult Version (PedsQL-YA-J) and determine the feasibility, reliability, and validity of the scales. Translation equivalence and content validity were verified using back-translation and cognitive debriefing tests. A total of 428 young adults recruited from one university, two vocational schools, or five companies completed questionnaires. We determined questionnaire feasibility, internal consistency, and test-retest reliability; checked concurrent validity against the Center for Epidemiologic Studies Depression Scale (CES-D); determined convergent and discriminant validity with the Medical Outcome Study 36-item Short Form Health Survey (SF-36); described known-groups validity with regard to subjective symptoms, illness or injury requiring regular medical visits, and depression; and verified factorial validity. All scales were internally consistent (Cronbach's coefficient alpha = 0.77-0.86); test-retest reliability was acceptable (intraclass correlation coefficient = 0.57-0.69); and all scales were concurrently valid with depression (Pearson's correlation coefficient = 0.43-0.57). The scales convergent and discriminant validity with the SF-36 and CES-D were acceptable. Evaluation of known-groups validity confirmed that the Physical Functioning scale was sensitive for subjective symptoms, the Emotional Functioning scale for depression, and the Work/School Functioning scale for illness or injury requiring regular medical visits. Exploratory factor analysis found a six-factor structure consistent with the assumed structure (cumulative proportion = 57.0%). The PedsQL-YA-J is suitable for assessing health-related quality of life in young adults in education, employment, or training, and for clinical trials and epidemiological research.

Scaling Limits and Generic Bounds for Exploration Processes

NASA Astrophysics Data System (ADS)

Bermolen, Paola; Jonckheere, Matthieu; Sanders, Jaron

2017-12-01

We consider exploration algorithms of the random sequential adsorption type both for homogeneous random graphs and random geometric graphs based on spatial Poisson processes. At each step, a vertex of the graph becomes active and its neighboring nodes become blocked. Given an initial number of vertices N growing to infinity, we study statistical properties of the proportion of explored (active or blocked) nodes in time using scaling limits. We obtain exact limits for homogeneous graphs and prove an explicit central limit theorem for the final proportion of active nodes, known as the jamming constant, through a diffusion approximation for the exploration process which can be described as a unidimensional process. We then focus on bounding the trajectories of such exploration processes on random geometric graphs, i.e., random sequential adsorption. As opposed to exploration processes on homogeneous random graphs, these do not allow for such a dimensional reduction. Instead we derive a fundamental relationship between the number of explored nodes and the discovered volume in the spatial process, and we obtain generic bounds for the fluid limit and jamming constant: bounds that are independent of the dimension of space and the detailed shape of the volume associated to the discovered node. Lastly, using coupling techinques, we give trajectorial interpretations of the generic bounds.

Space Generic Open Avionics Architecture (SGOAA) standard specification

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1994-01-01

This standard establishes the Space Generic Open Avionics Architecture (SGOAA). The SGOAA includes a generic functional model, processing structural model, and an architecture interface model. This standard defines the requirements for applying these models to the development of spacecraft core avionics systems. The purpose of this standard is to provide an umbrella set of requirements for applying the generic architecture models to the design of a specific avionics hardware/software processing system. This standard defines a generic set of system interface points to facilitate identification of critical services and interfaces. It establishes the requirement for applying appropriate low level detailed implementation standards to those interfaces points. The generic core avionics functions and processing structural models provided herein are robustly tailorable to specific system applications and provide a platform upon which the interface model is to be applied.

The PedsQL Multidimensional Fatigue Scale in pediatric rheumatology: reliability and validity.

PubMed

Varni, James W; Burwinkle, Tasha M; Szer, Ilona S

2004-12-01

. The PedsQL (Pediatric Quality of Life Inventory) is a modular instrument designed to measure health related quality of life (HRQOL) in children and adolescents ages 2-18 years. The recently developed 18-item PedsQL Multidimensional Fatigue Scale was designed to measure fatigue in pediatric patients and comprises the General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items), and Cognitive Fatigue Scale (6 items). The PedsQL 4.0 Generic Core Scales were developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules. The PedsQL 3.0 Rheumatology Module was designed to measure pediatric rheumatology-specific HRQOL. Methods. The PedsQL Multidimensional Fatigue Scale, Generic Core Scales, and Rheumatology Module were administered to 163 children and 154 parents (183 families accrued overall) recruited from a pediatric rheumatology clinic. Results. Internal consistency reliability for the PedsQL Multidimensional Fatigue Scale Total Score (a = 0.95 child, 0.95 parent report), General Fatigue Scale (a = 0.93 child, 0.92 parent), Sleep/Rest Fatigue Scale (a = 0.88 child, 0.90 parent), and Cognitive Fatigue Scale (a = 0.93 child, 0.96 parent) were excellent for group and individual comparisons. The validity of the PedsQL Multidimensional Fatigue Scale was confirmed through hypothesized intercorrelations with dimensions of generic and rheumatology-specific HRQOL. The PedsQL Multidimensional Fatigue Scale distinguished between healthy children and children with rheumatic diseases as a group, and was associated with greater disease severity. Children with fibromyalgia manifested greater fatigue than children with other rheumatic diseases. The results confirm the initial reliability and validity of the PedsQL Multidimensional Fatigue Scale in pediatric rheumatology.

A Nonlinear Dynamic Inversion Predictor-Based Model Reference Adaptive Controller for a Generic Transport Model

NASA Technical Reports Server (NTRS)

Campbell, Stefan F.; Kaneshige, John T.

2010-01-01

Presented here is a Predictor-Based Model Reference Adaptive Control (PMRAC) architecture for a generic transport aircraft. At its core, this architecture features a three-axis, non-linear, dynamic-inversion controller. Command inputs for this baseline controller are provided by pilot roll-rate, pitch-rate, and sideslip commands. This paper will first thoroughly present the baseline controller followed by a description of the PMRAC adaptive augmentation to this control system. Results are presented via a full-scale, nonlinear simulation of NASA s Generic Transport Model (GTM).

Health-related quality of life for pediatric emergency department febrile illnesses: an evaluation of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales.

PubMed

Mistry, Rakesh D; Stevens, Molly W; Gorelick, Marc H

2009-01-29

We sought to assess the validity and short-term responsiveness of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL) for febrile illnesses evaluated in the pediatric emergency department (ED). Prospective cohort study of children 2-18 years discharged after ED evaluation for fever (>or= 38 degrees C). Self-administered, parent-report of health-related quality of life (HRQOL) was assessed using the PedsQL Acute Version, a validated HRQOL instrument. HRQOL was measured on ED presentation and at 7-10 day follow-up. At follow-up, duration of fever, child functional impairment, missed daycare/school, and disrupted family unit functioning, were assessed. Of 160 subjects enrolled, 97 (61%) completed the study; mean follow-up was 8.7 days. Mean total HRQOL score on ED presentation was 76.4; mean follow-up score was 86.3. Compared to subjects that returned to baseline, statistically significant differences in HRQOL were noted for those with prolonged fever, child functional impairment, and relapse. Significant correlation was observed between HRQOL at follow-up and days of daycare/school missed (r = -0.35, p = .003) and days of family disruption (r = -0.43, p < .001). Mean change in HRQOL within subjects, from ED visit to follow-up, was +9.8 (95% CI: 5.6-14.6). Effect size was 0.53, indicating moderate responsiveness. The PedsQL appears to be a valid and responsive indicator of HRQOL for short-term febrile illnesses evaluated in the ED.

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

ERIC Educational Resources Information Center

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…

Validity and responsiveness of the pediatric quality of life inventory (PedsQL) 4.0 generic core scales in the pediatric inpatient setting.

PubMed

Desai, Arti D; Zhou, Chuan; Stanford, Susan; Haaland, Wren; Varni, James W; Mangione-Smith, Rita M

2014-12-01

Validated patient-reported outcomes responsive to clinical change are needed to evaluate the effectiveness of quality improvement interventions. To evaluate responsiveness, construct validity, and predictive validity of the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales in the pediatric inpatient setting. Prospective, cohort study of parents and caregivers of patients 1 month to 18 years old (n = 4637) and patients 13 to 18 years old (n = 359) admitted to Seattle Children's Hospital between October 1, 2011, and December 31, 2013. Of 7184 eligible participants invited to complete the survey, 4637 (64.5%) completed the PedsQL on admission, and of these 2694 (58.1%) completed the follow-up survey 2 to 8 weeks after discharge. Responsiveness was assessed by calculating improvement scores (difference between follow-up and admission scores). Construct validity was examined by comparing the mean improvement scores for known groups differing by medical complexity. Predictive validity was assessed using Poisson regression to examine associations among admission scores, prolonged length of stay (≥3 days), and 30-day readmissions or emergency department (ED) return visits. Similar models examined the association between improvement scores and risk for 30-day readmissions or ED return visits. The mean (SD) PedsQL improvement scores (scale, 0-100) were 22.1 (22.7) for total, 29.4 (32.4) for physical, and 17.1 (21.0) for psychosocial. The mean PedsQL total improvement scores were lower for patients with medically complex conditions compared with patients without chronic conditions (13.7 [95% CI, 11.6-15.8] vs. 24.1 [95% CI, 22.4-25.7], P < .001). A 10-point decrement in the PedsQL total admission score below the established community-based mean was associated with an increase in risk for prolonged length of stay (15% [95% CI, 13%-17%]), 30-day readmissions (8% [95% CI, 3%-14%]), and ED return visits (13% [95% CI, 6%-20%]). A 5-point decrement

What use is generic prescribing?

PubMed Central

Archer, Michael

1985-01-01

The dispensing of generic preparations at four dispensing chemist shops was investigated by means of a questionnaire. Certain generic prescriptions result in the dispensing of proprietary products despite the existence of generic preparations, and the pharmacist may be reimbursed for the cost of the proprietary drug which has been dispensed. Not all generic prescriptions result in the dispensing of cheaper drugs because of the methods of payment to chemists. If doctors write more generic prescriptions there will ultimately be more dispensing of generic products. Even in the case of drugs still under patent, prescribing by generic name should be encouraged. The savings achieved by generic prescribing are to some extent at the cost of the dispensing chemists. The method and scale of payments for dispensing requires urgent review. PMID:4032358

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

NASA Technical Reports Server (NTRS)

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

[PedsQL™ 4.0 Generic Core Infant Scales Parents Report for infants (ages 13-24 months). Linguistic validation from original US English version to Italian version].

PubMed

González-Melado, F J; Di Ciommo, V M; Di Pietro, M; Chiarini Testa, M B; Cutrera, R

2013-10-01

The purpose of this research was to show the translation and linguistic validation of the PedsQL™ 4.0 Generic Core Infant Scales Parents Report for Infants (ages 13-24 months) from its original English version to Italian language. The linguistic validation consists in three steps: a) different forward translations from the original US English instrument to Italian; this step includes the drawing of a "reconciliation" version (version 1); b) backward translations from the Italian reconciliation version to US English; c) patient testing: the second version of the questionnaire (obtained after the backward translations) has to be tested on a panel of a minimum of 5 respondents, throughout cognitive interviewing methodology, in order to obtain the final italian version of the PedsQL™ Parents Report for Infants (ages 13-24 months). In this report we summarize the third step of this process. To study the content validity, the applicability and comprehension of our questionnarie translation, we tested it through a qualitative methodology in a sample of parents whose children were hospitalized in Bambino Gesù Children's Hospital with two different kinds of interview: 4 parents responded to the questions posed through a "thinkaloud interview" and 3 parents responded to the questionnaire and to a "respondent debriefing" interview. We modified the main question of each section and also one of the possible answer in order to maintain the Italian translation that appeared in others PedsQL™. We did not modify the questions of each section because respondents expressed that are clearly comprehensible and easy to understand.

Scaling relations of halo cores for self-interacting dark matter

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

Lin, Henry W.; Loeb, Abraham, E-mail: henrylin@college.harvard.edu, E-mail: aloeb@cfa.harvard.edu

2016-03-01

Using a simple analytic formalism, we demonstrate that significant dark matter self-interactions produce halo cores that obey scaling relations nearly independent of the underlying particle physics parameters such as the annihilation cross section and the mass of the dark matter particle. For dwarf galaxies, we predict that the core density ρ{sub c} and the core radius r{sub c} should obey ρ{sub c} r{sub c} ≈ 41 M{sub ⊙} pc{sup −2} with a weak mass dependence ∼ M{sup 0.2}. Remarkably, such a scaling relation has recently been empirically inferred. Scaling relations involving core mass, core radius, and core velocity dispersion are predicted and agree well with observationalmore » data. By calibrating against numerical simulations, we predict the scatter in these relations and find them to be in excellent agreement with existing data. Future observations can test our predictions for different halo masses and redshifts.« less

The Generic Short Patient Experiences Questionnaire (GS-PEQ): identification of core items from a survey in Norway

PubMed Central

2011-01-01

Background Questionnaires are commonly used to collect patient, or user, experiences with health care encounters; however, their adaption to specific target groups limits comparison between groups. We present the construction of a generic questionnaire (maximum of ten questions) for user evaluation across a range of health care services. Methods Based on previous testing of six group-specific questionnaires, we first constructed a generic questionnaire with 23 items related to user experiences. All questions included a "not applicable" response option, as well as a follow-up question about the item's importance. Nine user groups from one health trust were surveyed. Seven groups received questionnaires by mail and two by personal distribution. Selection of core questions was based on three criteria: applicability (proportion "not applicable"), importance (mean scores on follow-up questions), and comprehensiveness (content coverage, maximum two items per dimension). Results 1324 questionnaires were returned providing subsample sizes ranging from 52 to 323. Ten questions were excluded because the proportion of "not applicable" responses exceeded 20% in at least one user group. The number of remaining items was reduced to ten by applying the two other criteria. The final short questionnaire included items on outcome (2), clinician services (2), user involvement (2), incorrect treatment (1), information (1), organisation (1), and accessibility (1). Conclusion The Generic Short Patient Experiences Questionnaire (GS-PEQ) is a short, generic set of questions on user experiences with specialist health care that covers important topics for a range of groups. It can be used alone or with other instruments in quality assessment or in research. The psychometric properties and the relevance of the GS-PEQ in other health care settings and countries need further evaluation. PMID:21510871

Development and psychometric evaluation of the Core Nurse Resource Scale.

PubMed

Simpson, Michelle R

2010-11-01

To examine the factor structure, internal consistency reliability and concurrent-related validity of the Core Nurse Resource Scale. A cross-sectional survey study design was used to obtain a sample of 149 nurses and nursing staff [Registered Nurse (RNs), Licensed Practical Nurse (LPNs) and Certified Nursing Assistant (CNAs)] working in long-term care facilities. Exploratory factor analysis, Cronbach's alpha and bivariate correlations were used to evaluate validity and reliability. Exploratory factor analysis yielded a scale with 18 items on three factors, accounting for 52% of the variance in scores. Internal consistency reliability for the composite and Core Nurse Resource Scale factors ranged from 0.79 to 0.91. The Core Nurse Resource Scale composite scale and subscales correlated positively with a measure of work engagement (r=0.247-0.572). The initial psychometric evaluation of the Core Nurse Resource Scale demonstrates it is a sound measure. Further validity and reliability assessment will need to be explored and assessed among nurses and other nursing staff working in other practice settings. The intent of the Core Nurse Resource Scale is to evaluate the presence of physical, psychological and social resources of the nursing work environment, to identify workplaces at risk for disengaged (low work engagement) nursing staff and to provide useful diagnostic information to healthcare administrators interested in interventions to improve the nursing work environment. © 2010 The Author. Journal compilation © 2010 Blackwell Publishing Ltd.

Measuring health-related quality of life in children living in HIV/AIDS-affected families in rural areas in Yunnan, China: Preliminary reliability and validity of the Chinese version of PedsQL 4.0 generic core scales.

PubMed

Xu, Tao; Wu, Zunyou; Yan, Zhihua; Rou, Keming; Duan, Song

2010-02-01

To investigate the preliminary reliability and validity of the Chinese Mandarin version of the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales in a sample of general children and children living in HIV/AIDS-affected families. The PedsQL 4.0 was administered to 116 children aged 8-18 years from HIV/AIDS-affected families and 115 of their caregivers. The questionnaire was also administered to a control group of 109 children and 107 of their caregivers. Most of the self-report and proxy-report scales in both groups exceeded the reliability standard of 0.70, whereas the self-report emotional functioning and school functioning subscales were slightly less than 0.70. On average, children living in HIV/AIDS-affected families scored significantly lower than the control group. The level of agreement between self-reports and proxy reports was low. Correlations were higher on average for the younger age group than for the older age group. The Chinese Mandarin version of PedsQL 4.0 is a valid and reliable instrument for use with children living in HIV families. The health-related quality of life for children living in HIV families is lower than children from ordinary families.

Skin rash during treatment with generic itraconazole.

PubMed

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.

Skin rash during treatment with generic itraconazole

PubMed Central

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-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. PMID:24799820

Space Generic Open Avionics Architecture (SGOAA) standard specification

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1993-01-01

The purpose of this standard is to provide an umbrella set of requirements for applying the generic architecture interface model to the design of a specific avionics hardware/software system. This standard defines a generic set of system interface points to facilitate identification of critical interfaces and establishes the requirements for applying appropriate low level detailed implementation standards to those interface points. The generic core avionics system and processing architecture models provided herein are robustly tailorable to specific system applications and provide a platform upon which the interface model is to be applied.

GERICOS: A Generic Framework for the Development of On-Board Software

NASA Astrophysics Data System (ADS)

Plasson, P.; Cuomo, C.; Gabriel, G.; Gauthier, N.; Gueguen, L.; Malac-Allain, L.

2016-08-01

This paper presents an overview of the GERICOS framework (GEneRIC Onboard Software), its architecture, its various layers and its future evolutions. The GERICOS framework, developed and qualified by LESIA, offers a set of generic, reusable and customizable software components for the rapid development of payload flight software. The GERICOS framework has a layered structure. The first layer (GERICOS::CORE) implements the concept of active objects and forms an abstraction layer over the top of real-time kernels. The second layer (GERICOS::BLOCKS) offers a set of reusable software components for building flight software based on generic solutions to recurrent functionalities. The third layer (GERICOS::DRIVERS) implements software drivers for several COTS IP cores of the LEON processor ecosystem.

The Generic Resolution Advisor and Conflict Evaluator (GRACE) for Unmanned Aircraft Detect-And-Avoid Systems

NASA Technical Reports Server (NTRS)

Abramson, Michael; Refai, Mohamad; Santiago, Confesor

2017-01-01

The paper describes the Generic Resolution Advisor and Conflict Evaluator (GRACE), a novel alerting and guidance algorithm that combines flexibility, robustness, and computational efficiency. GRACE is generic since it was designed without any assumptions regarding temporal or spatial scales, aircraft performance, or its sensor and communication systems. Therefore, GRACE was adopted as a core component of the Java Architecture for Detect-And-Avoid (DAA) Extensibility and Modeling, developed by NASA as a research and modeling tool for Unmanned Aerial Systems Integration in the National Airspace System (NAS). GRACE has been used in a number of real-time and fast-time experiments supporting evolving requirements of DAA research, including parametric studies, NAS-wide simulations, human-in-the-loop experiments, and live flight tests.

Is there a relationship between patient beliefs or communication about generic drugs and medication utilization?

PubMed

Shrank, William H; Cadarette, Suzanne M; Cox, Emily; Fischer, Michael A; Mehta, Jyotsna; Brookhart, Alan M; Avorn, Jerry; Choudhry, Niteesh K

2009-03-01

Insurers and policymakers strive to stimulate more cost-effective prescribing and, increasingly, are educating beneficiaries about generics. To evaluate the relationship between patient beliefs and communication about generic drugs and actual drug use. We performed a national mailed survey of a random sample of 2500 commercially-insured adults. Patient responses were linked to pharmacy claims data to assess actual generic medication use. We used factor analysis to develop 5 multi-item scales from patient survey responses that measured: (1) general preferences for generics, (2) generic safety/effectiveness, (3) generic cost/value, (4) comfort with generic substitution, and (5) communication with providers about generics. The relationship between each scale and the proportion of prescriptions filled for generics was assessed using linear regression, controlling for demographic, health, and insurance characteristics. Separate models were created for each scale and then all 5 scales were included simultaneously in a fully-adjusted model. The usable response rate was 48%. When evaluated independently, a 1 SD increase in each of the 5 scales was associated with a 3.1% to 6.3% increase in generic drug use (P < 0.05 for each). In the fully adjusted model, only 2 scales were significantly associated with generic drug use: comfort with generic substitution (P = 0.021) and communication with providers about generic drugs (P = 0.012). Generic drug use is most closely associated with the 2 actionable items we evaluated: communication with providers about generics and comfort with generic substitution. Educational campaigns that focus on these 2 domains may be most effective at influencing generic drug use.

Two-dimensional ice mapping of molecular cores

NASA Astrophysics Data System (ADS)

Noble, J. A.; Fraser, H. J.; Pontoppidan, K. M.; Craigon, A. M.

2017-06-01

We present maps of the column densities of H2O, CO2 and CO ices towards the molecular cores B 35A, DC 274.2-00.4, BHR 59 and DC 300.7-01.0. These ice maps, probing spatial distances in molecular cores as low as 2200 au, challenge the traditional hypothesis that the denser the region observed, the more ice is present, providing evidence that the relationships between solid molecular species are more varied than the generic picture we often adopt to model gas-grain chemical processes and explain feedback between solid phase processes and gas phase abundances. We present the first combined solid-gas maps of a single molecular species, based upon observations of both CO ice and gas phase C18O towards B 35A, a star-forming dense core in Orion. We conclude that molecular species in the solid phase are powerful tracers of 'small-scale' chemical diversity, prior to the onset of star formation. With a component analysis approach, we can probe the solid phase chemistry of a region at a level of detail greater than that provided by statistical analyses or generic conclusions drawn from single pointing line-of-sight observations alone.

Is There a Relationship Between Patient Beliefs or Communication About Generic Drugs and Medication Utilization?

PubMed Central

Shrank, William H.; Cadarette, Suzanne M.; Cox, Emily; Fischer, Michael A.; Mehta, Jyotsna; Brookhart, Alan M.; Avorn, Jerry; Choudhry, Niteesh K.

2009-01-01

Background Insurers and policymakers strive to stimulate more cost-effective prescribing and, increasingly, are educating beneficiaries about generics. Objectives To evaluate the relationship between patient beliefs and communication about generic drugs and actual drug use. Research Design and Subjects We performed a national mailed survey of a random sample of 2500 commercially-insured adults. Patient responses were linked to pharmacy claims data to assess actual generic medication use. Measures We used factor analysis to develop 5 multi-item scales from patient survey responses that measured: (1) general preferences for generics, (2) generic safety/effectiveness, (3) generic cost/value, (4) comfort with generic substitution, and (5) communication with providers about generics. The relationship between each scale and the proportion of prescriptions filled for generics was assessed using linear regression, controlling for demographic, health, and insurance characteristics. Separate models were created for each scale and then all 5 scales were included simultaneously in a fully-adjusted model. Results The usable response rate was 48%. When evaluated independently, a 1 SD increase in each of the 5 scales was associated with a 3.1% to 6.3% increase in generic drug use (P < 0.05 for each). In the fully adjusted model, only 2 scales were significantly associated with generic drug use: comfort with generic substitution (P = 0.021) and communication with providers about generic drugs (P = 0.012). Conclusions Generic drug use is most closely associated with the 2 actionable items we evaluated: communication with providers about generics and comfort with generic substitution. Educational campaigns that focus on these 2 domains may be most effective at influencing generic drug use. PMID:19194329

Patients’ beliefs about generic medicines in Malaysia

PubMed Central

Wong, Zhi Y.; Hassali, Mohamed A.; Alrasheedy, Alian A.; Saleem, Fahad; Yahaya, Abdul H.; Aljadhey, Hisham

2014-01-01

Background: Acceptance of generic medicines by patients is an essential factor given that they are the end users of these medicines. In fact, adequate knowledge and positive perceptions are prerequisite to patients’ acceptance and use of generic medicines. Objective: To assess the current belief and views of patients about generic medicines in Malaysia. Method: This was a self-administered questionnaire-based study. The study was conducted with patients visiting outpatient pharmacy department at a tertiary care hospital in Malaysia. The Malaysian version of Generic Medicines Scale (GMS) was used. The GMS consists of two subscales: efficacy and similarity of generic medicines to original brand medicines. The efficacy subscale consists of 10 items while the similarity subscale consists of 6 items. The responses to the items were framed as a five-point Likert scale (1=strongly disagree to 5=strongly agree). Results: A total of 202 out of 300 patients participated in the study, giving a response rate of 67.3%. In this study, only 49% of them (n=99) knew the term ‘generic medicine’. Moreover, only 53.5% of the respondents (n=108) believed that the efficacy of generic medicines was the same as original brand medicines. In terms of quality, only 44% of the respondents (n=89) disagreed that generic medicines were of a lower quality. About one third (n=65, 32.2%) believed that generic medicines were cheaper because they were less efficacious. In terms of side effects, 44.5% of the respondents (n=90) believed that generic medicines had the same side effect profile as original brand medicines. Conclusions: The study finding showed that almost half of the respondents had negative belief in generic medicines. Similarly, many patients were not aware of the similarities and differences between generic and original brand medicines. Therefore, there is a need to provide patients with adequate information about generic medicines. PMID:25580171

Space Generic Open Avionics Architecture (SGOAA) reference model technical guide

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1993-01-01

This report presents a full description of the Space Generic Open Avionics Architecture (SGOAA). The SGOAA consists of a generic system architecture for the entities in spacecraft avionics, a generic processing architecture, and a six class model of interfaces in a hardware/software system. The purpose of the SGOAA is to provide an umbrella set of requirements for applying the generic architecture interface model to the design of specific avionics hardware/software systems. The SGOAA defines a generic set of system interface points to facilitate identification of critical interfaces and establishes the requirements for applying appropriate low level detailed implementation standards to those interface points. The generic core avionics system and processing architecture models provided herein are robustly tailorable to specific system applications and provide a platform upon which the interface model is to be applied.

Space Generic Open Avionics Architecture (SGOAA): Overview

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1992-01-01

A space generic open avionics architecture created for NASA is described. It will serve as the basis for entities in spacecraft core avionics, capable of being tailored by NASA for future space program avionics ranging from small vehicles such as Moon ascent/descent vehicles to large ones such as Mars transfer vehicles or orbiting stations. The standard consists of: (1) a system architecture; (2) a generic processing hardware architecture; (3) a six class architecture interface model; (4) a system services functional subsystem architectural model; and (5) an operations control functional subsystem architectural model.

The PedsQL multidimensional fatigue scale in pediatric obesity: feasibility, reliability and validity.

PubMed

Varni, James W; Limbers, Christine A; Bryant, William P; Wilson, Don P

2010-01-01

The PedsQL (Pediatric Quality of Life Inventory) is a modular instrument designed to measure health-related quality of life (HRQOL) and disease-specific symptoms in children and adolescents. The PedsQL Multidimensional Fatigue Scale was designed as a child self-report and parent proxy-report generic symptom-specific instrument to measure fatigue in pediatric patients. The objective of the present study was to determine the feasibility, reliability, and validity of the PedsQL Multidimensional Fatigue Scale in pediatric obesity. The 18-item PedsQL Multidimensional Fatigue Scale (General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue domains) and the PedsQL 4.0 Generic Core Scales were completed by 41 pediatric patients with a physician-diagnosis of obesity and 43 parents from a hospital-based Pediatric Endocrinology Clinic. The PedsQL Multidimensional Fatigue Scale evidenced minimal missing responses (1.6%, child report; 0.5%, parent report), achieved excellent reliability for the Total Fatigue Scale Score (alpha = 0.90 child report, 0.90 parent report), distinguished between pediatric patients with obesity and healthy children, and was significantly correlated with the PedsQL 4.0 Generic Core Scales supporting construct validity. Pediatric patients with obesity experienced fatigue comparable with pediatric patients receiving cancer treatment, demonstrating the relative severity of their fatigue symptoms. The results demonstrate the measurement properties of the PedsQL Multidimensional Fatigue Scale in pediatric obesity. The findings suggest that the PedsQL Multidimensional Fatigue Scale may be utilized in the standardized evaluation of fatigue in pediatric patients with obesity.

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

PubMed Central

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

2018-01-01

Background While generic drugs are therapeutically equivalent to brand drugs, some patients and healthcare providers remain uncertain about whether they produce identical outcomes. Authorized generics, which are identical in formulation to corresponding brand drugs but marketed as a generic, provide a unique post-marketing opportunity to study whether utilization patterns are influenced by perceptions of generic drugs. Objectives To compare generic-to-brand switchback rates between generics and authorized generics. Methods A retrospective cohort study was conducted using claims and electronic health records data from a regional U.S. healthcare system. Ten drugs with authorized generics and generics marketed between 1999 and 2014 were evaluated. Eligible adult patients received a brand drug during the 6 months preceding generic entry, and then switched to a generic or authorized generic. Patients in this cohort were followed for up to 30 months from the index switch date to evaluate occurrence of generic-to-brand switchbacks. Switchback rates were compared between patients on authorized generics versus generics using Kaplan-Meier curves and Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson comorbidity score, pre-index drug use characteristics, and pre-index healthcare utilization. Results Among 5,542 unique patients that switched from brand-to-generic or brand-to-authorized generic, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for authorized generics compared with generics (HR=0.86; 95% CI 0.65-1.15). The likelihood of switchback was higher for alendronate (HR=1.64; 95% CI 1.20-2.23) and simvastatin (HR=1.81; 95% CI 1.30-2.54) and lower for amlodipine (HR=0.27; 95% CI 0.17-0.42) compared with other drugs in the cohort. Conclusions Overall switchback rates were similar between authorized generic and generic drug users, indirectly supporting similar efficacy and tolerability profiles for

The PedsQL Multidimensional Fatigue Scale in type 1 diabetes: feasibility, reliability, and validity.

PubMed

Varni, James W; Limbers, Christine A; Bryant, William P; Wilson, Don P

2009-08-01

The Pediatric Quality of Life Inventory (PedsQL, Mapi Research Trust, Lyon, France; www.pedsql.org) is a modular instrument designed to measure health-related quality of life and disease-specific symptoms in children and adolescents. The PedsQL Multidimensional Fatigue Scale was designed as a child self-report and parent proxy-report generic symptom-specific instrument to measure fatigue in pediatric patients. The objective of the present study was to determine the feasibility, reliability, and validity of the PedsQL Multidimensional Fatigue Scale in type 1 diabetes. The 18-item PedsQL Multidimensional Fatigue Scale (General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue domains) and the PedsQL 4.0 Generic Core Scales were administered to 83 pediatric patients with type 1 diabetes and 84 parents. The PedsQL Multidimensional Fatigue Scale evidenced minimal missing responses (0.3% child report and 0.3% parent report), achieved excellent reliability for the Total Fatigue Scale score (alpha= 0.92 child report, 0.94 parent report), distinguished between pediatric patients with diabetes and healthy children, and was significantly correlated with the PedsQL 4.0 Generic Core Scales supporting construct validity. Pediatric patients with diabetes experienced fatigue that was comparable to pediatric patients with cancer on treatment, demonstrating the relative severity of their fatigue symptoms. The results demonstrate the measurement properties of the PedsQL Multidimensional Fatigue Scale in type 1 diabetes. The findings suggest that the PedsQL Multidimensional Fatigue Scale may be utilized in the standardized evaluation of fatigue in pediatric patients with type 1 diabetes.

Development of a Dynamically Scaled Generic Transport Model Testbed for Flight Research Experiments

NASA Technical Reports Server (NTRS)

Jordan, Thomas; Langford, William; Belcastro, Christine; Foster, John; Shah, Gautam; Howland, Gregory; Kidd, Reggie

2004-01-01

This paper details the design and development of the Airborne Subscale Transport Aircraft Research (AirSTAR) test-bed at NASA Langley Research Center (LaRC). The aircraft is a 5.5% dynamically scaled, remotely piloted, twin-turbine, swept wing, Generic Transport Model (GTM) which will be used to provide an experimental flight test capability for research experiments pertaining to dynamics modeling and control beyond the normal flight envelope. The unique design challenges arising from the dimensional, weight, dynamic (inertial), and actuator scaling requirements necessitated by the research community are described along with the specific telemetry and control issues associated with a remotely piloted subscale research aircraft. Development of the necessary operational infrastructure, including operational and safety procedures, test site identification, and research pilots is also discussed. The GTM is a unique vehicle that provides significant research capacity due to its scaling, data gathering, and control characteristics. By combining data from this testbed with full-scale flight and accident data, wind tunnel data, and simulation results, NASA will advance and validate control upset prevention and recovery technologies for transport aircraft, thereby reducing vehicle loss-of-control accidents resulting from adverse and upset conditions.

Generic phytosanitary irradiation treatments

NASA Astrophysics Data System (ADS)

Hallman, Guy J.

2012-07-01

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

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

PubMed

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

2017-04-01

Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic-to-brand switchback rates between generic and AGs. Retrospective cohort study. Claims and electronic health record data from a regional U.S. health care system. The full cohort consisted of 5542 unique patients who received select branded drugs during the 6 months prior to their generic drug market availability (between 1999 and 2014) and then were switched to an AG or generic drug within 30 months of generic drug entry. For these patients, 5929 unique patient-drug combinations (867 with AGs and 5062 with generic drugs) were evaluated. Ten drugs with AGs and generics marketed between 1999 and 2014 were evaluated. The date of the first generic prescription was considered the index date for each drug, and it marked the beginning of follow-up to evaluate the occurrence of generic-to-brand switchback patterns over the subsequent 30 months. Switchback rates were compared between patients receiving AGs versus those receiving generics using multivariable Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson Comorbidity Score, pre-index drug use characteristics, and pre-index health care utilization. Among the 5542 unique patients who switched from brand to generic or brand to AG, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for AGs compared with generics (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15). The likelihood of switchback was higher for alendronate (HR 1.64, 95% CI 1.20-2.23) and simvastatin (HR 1.81, 95% CI 1.30-2.54) and lower for amlodipine (HR 0.27, 95% CI 0.17-0.42) compared with the other drugs evaluated. Overall switchback rates were similar

A new scale for disaster nursing core competencies: Development and psychometric testing.

PubMed

Al Thobaity, Abdulellah; Williams, Brett; Plummer, Virginia

2016-02-01

All nurses must have core competencies in preparing for, responding to and recovering from a disaster. In the Kingdom of Saudi Arabia (KSA), as in many other countries, disaster nursing core competencies are not fully understood and lack reliable, validated tools. Thus, it is imperative to develop a scale for exploring disaster nursing core competencies, roles and barriers in the KSA. This study's objective is to develop a valid, reliable scale that identifies and explores core competencies of disaster nursing, nurses' roles in disaster management and barriers to developing disaster nursing in the KSA. This study developed a new scale testing its validity and reliability. A principal component analysis (PCA) was used to develop and test psychometric properties of the new scale. The PCA used a purposive sample of nurses from emergency departments in two hospitals in the KSA. Participants rated 93 paper-based, self-report questionnaire items from 1 to 10 on a Likert scale. PCA using Varimax rotation was conducted to explore factors emerging from responses. The study's participants were 132 nurses (66% response rate). PCA of the 93 questionnaire items revealed 49 redundant items (which were deleted) and 3 factors with eigenvalues of >1. The remaining 44 items accounted for 77.3% of the total variance. The overall Cronbach's alpha was 0.96 for all factors: 0.98 for Factor 1, 0.92 for Factor 2 and 0.86 for Factor 3. This study provided a validated, reliable scale for exploring nurses' core competencies, nurses' roles and barriers to developing disaster nursing in the KSA. The new scale has many implications, such as for improving education, planning and curricula. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

The FRIGG project: From intermediate galactic scales to self-gravitating cores

NASA Astrophysics Data System (ADS)

Hennebelle, Patrick

2018-03-01

Context. Understanding the detailed structure of the interstellar gas is essential for our knowledge of the star formation process. Aim. The small-scale structure of the interstellar medium (ISM) is a direct consequence of the galactic scales and making the link between the two is essential. Methods: We perform adaptive mesh simulations that aim to bridge the gap between the intermediate galactic scales and the self-gravitating prestellar cores. For this purpose we use stratified supernova regulated ISM magneto-hydrodynamical simulations at the kpc scale to set up the initial conditions. We then zoom, performing a series of concentric uniform refinement and then refining on the Jeans length for the last levels. This allows us to reach a spatial resolution of a few 10-3 pc. The cores are identified using a clump finder and various criteria based on virial analysis. Their most relevant properties are computed and, due to the large number of objects formed in the simulations, reliable statistics are obtained. Results: The cores' properties show encouraging agreements with observations. The mass spectrum presents a clear powerlaw at high masses with an exponent close to ≃-1.3 and a peak at about 1-2 M⊙. The velocity dispersion and the angular momentum distributions are respectively a few times the local sound speed and a few 10-2 pc km s-1. We also find that the distribution of thermally supercritical cores present a range of magnetic mass-to-flux over critical mass-to-flux ratios, typically between ≃0.3 and 3 indicating that they are significantly magnetized. Investigating the time and spatial dependence of these statistical properties, we conclude that they are not significantly affected by the zooming procedure and that they do not present very large fluctuations. The most severe issue appears to be the dependence on the numerical resolution of the core mass function (CMF). While the core definition process may possibly introduce some biases, the peak tends to

Mediterranean dryland Mosaic: The effect of scale on core area metrics

NASA Astrophysics Data System (ADS)

Alhamad, Mohammad Noor; Alrababah, Mohammad

2014-05-01

Quantifying landscape spatial pattern is essential to understanding the relationship between landscape structure and ecological functions and process. Many landscape metrics have been developed to quantify spatial heterogeneity. Landscape metrics have been employed to measure the impact of humans on landscapes. We examined the response of four core areas metrics to a large range of grain sizes in Mediterranean dryland landscapes. The investigated metrics were (1) mean core area (CORE-MN), (2) area weighted mean core area (CORE-AM) , (3) total core area (TCA) and (4) core area percentage of landscape (CPLAND) within six land use types (urban, agriculture, olive orchids, forestry, shrubland and rangeland). Agriculture areas showed the highest value for minimum TCA (2779.4 ha) within the tested grain sizes, followed by rangeland (1778.3 ha) and Forest (1488.5 ha). On the other hand, shrubland showed the lowest TCA (8.0 ha). The minimum CPLAND values were ranged from 0.002 for shrubland to 0.682 for agriculture land use. The maximum CORE-MN among the tested land use type at all levels of grain sizes was exhibited by agriculture land use type (519.759 ha). The core area metrics showed three types of behavior in response to changing grain size in all landuse types. CORE-MN showed predictable relationship, best explained by non-linear responses to changing grain size (R2=0.99). Both TCA and CPLAND exhibited domain of scale effect in response to changing grain size. The threshold behavior for TCA and CPLAND was at the 4 x 4 grain size (about 1.3 ha). However, CORE-AM exhibited erratic behavior. The unique domain of scale-like behavior may be attributed to the unique characteristics of dryland Mediterranean landscapes; where both natural processes and ancient human activities play a great role in shaping the apparent pattern of the landscape

The PedsQL Multidimensional Fatigue Scale in young adults: feasibility, reliability and validity in a University student population.

PubMed

Varni, James W; Limbers, Christine A

2008-02-01

The PedsQL (Pediatric Quality of Life Inventory) is a modular instrument designed to measure health-related quality of life (HRQOL) and disease-specific symptoms in children and adolescents ages 2-18. The PedsQL Multidimensional Fatigue Scale was designed as a generic symptom-specific instrument to measure fatigue in pediatric patients ages 2-18. Since a sizeable number of pediatric patients prefer to remain with their pediatric providers after age 18, the objective of the present study was to determine the feasibility, reliability, and validity of the PedsQL Multidimensional Fatigue Scale in young adults. The 18-item PedsQL Multidimensional Fatigue Scale (General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue domains), the PedsQL 4.0 Generic Core Scales Young Adult Version, and the SF-8 Health Survey were completed by 423 university students ages 18-25. The PedsQL Multidimensional Fatigue Scale evidenced minimal missing responses, achieved excellent reliability for the Total Scale Score (alpha = 0.90), distinguished between healthy young adults and young adults with chronic health conditions, was significantly correlated with the relevant PedsQL 4.0 Generic Core Scales and the SF-8 standardized scores, and demonstrated a factor-derived structure largely consistent with the a priori conceptual model. The results demonstrate the measurement properties of the PedsQL Multidimensional Fatigue Scale in a convenience sample of young adult university students. The findings suggest that the PedsQL Multidimensional Fatigue Scale may be utilized in the evaluation of fatigue for a broad age range.

Mapping the core mass function to the initial mass function

NASA Astrophysics Data System (ADS)

Guszejnov, Dávid; Hopkins, Philip F.

2015-07-01

It has been shown that fragmentation within self-gravitating, turbulent molecular clouds (`turbulent fragmentation') can naturally explain the observed properties of protostellar cores, including the core mass function (CMF). Here, we extend recently developed analytic models for turbulent fragmentation to follow the time-dependent hierarchical fragmentation of self-gravitating cores, until they reach effectively infinite density (and form stars). We show that turbulent fragmentation robustly predicts two key features of the initial mass function (IMF). First, a high-mass power-law scaling very close to the Salpeter slope, which is a generic consequence of the scale-free nature of turbulence and self-gravity. We predict the IMF slope (-2.3) is slightly steeper than the CMF slope (-2.1), owing to the slower collapse and easier fragmentation of large cores. Secondly, a turnover mass, which is set by a combination of the CMF turnover mass (a couple solar masses, determined by the `sonic scale' of galactic turbulence, and so weakly dependent on galaxy properties), and the equation of state (EOS). A `soft' EOS with polytropic index γ < 1.0 predicts that the IMF slope becomes `shallow' below the sonic scale, but fails to produce the full turnover observed. An EOS, which becomes `stiff' at sufficiently low surface densities Σgas ˜ 5000 M⊙ pc-2, and/or models, where each collapsing core is able to heat and effectively stiffen the EOS of a modest mass (˜0.02 M⊙) of surrounding gas, are able to reproduce the observed turnover. Such features are likely a consequence of more detailed chemistry and radiative feedback.

Promoting and regulating generic medicines: Brazil in comparative perspective.

PubMed

da Fonseca, Elize Massard; Shadlen, Kenneth C

2017-04-20

Promoting the use of generic drugs can constitute a core instrument for countries' national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap for determining which dimensions of generic drug policy to assess and compare. This report fills that gap by considering national rules and regulations across four dimensions deemed crucial to any evaluation: demonstrated therapeutic equivalence; pharmaceutical packaging and labeling; drug prescription; and drug substitution. Furthermore, this report examines how the diverse interests of public and private sector stakeholders might shape generic drug policy and its implementation. To illustrate the challenges and conflicts behind policy development and implementation, this report focuses on the case of Brazil.

Parent proxy-report of their children's health-related quality of life: an analysis of 13,878 parents' reliability and validity across age subgroups using the PedsQL 4.0 Generic Core Scales.

PubMed

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

2007-01-03

Health-related quality of life (HRQOL) measurement has emerged as an important health outcome in clinical trials, clinical practice improvement strategies, and healthcare services research and evaluation. While pediatric patient self-report should be considered the standard for measuring perceived HRQOL, there are circumstances when children are too young, too cognitively impaired, too ill or fatigued to complete a HRQOL instrument, and reliable and valid parent proxy-report instruments are needed in such cases. Further, it is typically parents' perceptions of their children's HRQOL that influences healthcare utilization. Data from the PedsQL DatabaseSM were utilized to test the reliability and validity of parent proxy-report at the individual age subgroup level for ages 2-16 years as recommended by recent FDA guidelines. The sample analyzed represents parent proxy-report age data on 13,878 children ages 2 to 16 years from the PedsQL 4.0 Generic Core Scales DatabaseSM. Parents were recruited from general pediatric clinics, subspecialty clinics, and hospitals in which their children were being seen for well-child checks, mild acute illness, or chronic illness care (n = 3,718, 26.8%), and from a State Children's Health Insurance Program (SCHIP) in California (n = 10,160, 73.2%). The percentage of missing item responses for the parent proxy-report sample as a whole was 2.1%, supporting feasibility. The majority of the parent proxy-report scales across the age subgroups exceeded the minimum internal consistency reliability standard of 0.70 required for group comparisons, while the Total Scale Scores across the age subgroups approached or exceeded the reliability criterion of 0.90 recommended for analyzing individual patient scale scores. Construct validity was demonstrated utilizing the known groups approach. For each PedsQL scale and summary score, across age subgroups, healthy children demonstrated a statistically significant difference in HRQOL (better HRQOL) than

Development and validation of a tool to assess knowledge and attitudes towards generic medicines among students in Greece: The ATtitude TOwards GENerics (ATTOGEN) questionnaire

PubMed Central

Katsari, Vasiliki; Niakas, Dimitris

2017-01-01

Introduction The use of generic medicines is a cost-effective policy, often dictated by fiscal restraints. To our knowledge, no fully validated tool exploring the students’ knowledge and attitudes towards generic medicines exists. The aim of our study was to develop and validate a questionnaire exploring the knowledge and attitudes of M.Sc. in Health Care Management students and recent alumni’s towards generic drugs in Greece. Materials and methods The development of the questionnaire was a result of literature review and pilot-testing of its preliminary versions to researchers and students. The final version of the questionnaire contains 18 items measuring the respondents’ knowledge and attitude towards generic medicines on a 5-point Likert scale. Given the ordinal nature of the data, ordinal alpha and polychoric correlations were computed. The sample was randomly split into two halves. Exploratory factor analysis, performed in the first sample, was used for the creation of multi-item scales. Confirmatory factor analysis and Generalized Linear Latent and Mixed Model analysis (GLLAMM) with the use of the rating scale model were used in the second sample to assess goodness of fit. An assessment of internal consistency reliability, test-retest reliability, and construct validity was also performed. Results Among 1402 persons contacted, 986 persons completed our questionnaire (response rate = 70.3%). Overall Cronbach’s alpha was 0.871. The conjoint use of exploratory and confirmatory factor analysis resulted in a six-scale model, which seemed to fit the data well. Five of the six scales, namely trust, drug quality, state audit, fiscal impact and drug substitution were found to be valid and reliable, while the knowledge scale suffered only from low inter-scale correlations and a ceiling effect. However, the subsequent confirmatory factor and GLLAMM analyses indicated a good fit of the model to the data. Conclusions The ATTOGEN instrument proved to be a reliable

Development and validation of a tool to assess knowledge and attitudes towards generic medicines among students in Greece: The ATtitude TOwards GENerics (ATTOGEN) questionnaire.

PubMed

Domeyer, Philip J; Aletras, Vassilis; Anagnostopoulos, Fotios; Katsari, Vasiliki; Niakas, Dimitris

2017-01-01

The use of generic medicines is a cost-effective policy, often dictated by fiscal restraints. To our knowledge, no fully validated tool exploring the students' knowledge and attitudes towards generic medicines exists. The aim of our study was to develop and validate a questionnaire exploring the knowledge and attitudes of M.Sc. in Health Care Management students and recent alumni's towards generic drugs in Greece. The development of the questionnaire was a result of literature review and pilot-testing of its preliminary versions to researchers and students. The final version of the questionnaire contains 18 items measuring the respondents' knowledge and attitude towards generic medicines on a 5-point Likert scale. Given the ordinal nature of the data, ordinal alpha and polychoric correlations were computed. The sample was randomly split into two halves. Exploratory factor analysis, performed in the first sample, was used for the creation of multi-item scales. Confirmatory factor analysis and Generalized Linear Latent and Mixed Model analysis (GLLAMM) with the use of the rating scale model were used in the second sample to assess goodness of fit. An assessment of internal consistency reliability, test-retest reliability, and construct validity was also performed. Among 1402 persons contacted, 986 persons completed our questionnaire (response rate = 70.3%). Overall Cronbach's alpha was 0.871. The conjoint use of exploratory and confirmatory factor analysis resulted in a six-scale model, which seemed to fit the data well. Five of the six scales, namely trust, drug quality, state audit, fiscal impact and drug substitution were found to be valid and reliable, while the knowledge scale suffered only from low inter-scale correlations and a ceiling effect. However, the subsequent confirmatory factor and GLLAMM analyses indicated a good fit of the model to the data. The ATTOGEN instrument proved to be a reliable and valid tool, suitable for assessing students' knowledge and

The use of modified scaling factors in the design of high-power, non-linear, transmitting rod-core antennas

NASA Astrophysics Data System (ADS)

Jordan, Jared Williams; Dvorak, Steven L.; Sternberg, Ben K.

2010-10-01

In this paper, we develop a technique for designing high-power, non-linear, transmitting rod-core antennas by using simple modified scale factors rather than running labor-intensive numerical models. By using modified scale factors, a designer can predict changes in magnetic moment, inductance, core series loss resistance, etc. We define modified scale factors as the case when all physical dimensions of the rod antenna are scaled by p, except for the cross-sectional area of the individual wires or strips that are used to construct the core. This allows one to make measurements on a scaled-down version of the rod antenna using the same core material that will be used in the final antenna design. The modified scale factors were derived from prolate spheroidal analytical expressions for a finite-length rod antenna and were verified with experimental results. The modified scaling factors can only be used if the magnetic flux densities within the two scaled cores are the same. With the magnetic flux density constant, the two scaled cores will operate with the same complex permeability, thus changing the non-linear problem to a quasi-linear problem. We also demonstrate that by holding the number of turns times the drive current constant, while changing the number of turns, the inductance and core series loss resistance change by the number of turns squared. Experimental measurements were made on rod cores made from varying diameters of black oxide, low carbon steel wires and different widths of Metglas foil. Furthermore, we demonstrate that the modified scale factors work even in the presence of eddy currents within the core material.

The Psychometric Properties of an Arabic version of the PedsQL Multidimensional Fatigue Scale Tested for Children with Cancer.

PubMed

Al-Gamal, Ekhlas; Long, Tony

2017-09-01

Fatigue is considered to be one of the most reported symptoms experienced by children with cancer. A major aim of this study was to develop an Arabic version of the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale (child report) and to test its psychometric proprieties for the assessment of fatigue in Arabic children with cancer. The PedsQL Multidimensional Fatigue Scale (Arabic version) and the PedsQL TM 4.0 Generic Core scale (existing Arabic version) were completed by 70 Jordanian children with cancer. Cronbach's alpha coefficients were found to be 0.90 for the total PedsQL Multidimensional Fatigue Scale (Arabic version), 0.94 for the general fatigue subscale, 0.67 for the sleep/rest fatigue subscale, and 0.87 for the cognitive fatigue subscale. The PedsQL Multidimensional Fatigue Scale scores correlated significantly with the PedsQL TM 4.0 Generic Core scale and demonstrated good construct validity. The results demonstrate excellent reliability and good validity of the PedsQL Multidimensional Fatigue Scale (Arabic version) for children with cancer. This is the first validated scale that assesses fatigue in Arabic children with cancer. The English scale has been used with several pediatric clinical populations, so this Arabic version may be equally useful beyond the field of cancer.

Comparison of prestellar core elongations and large-scale molecular cloud structures in the Lupus I region

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

Poidevin, Frédérick; Ade, Peter A. R.; Hargrave, Peter C.

2014-08-10

Turbulence and magnetic fields are expected to be important for regulating molecular cloud formation and evolution. However, their effects on sub-parsec to 100 parsec scales, leading to the formation of starless cores, are not well understood. We investigate the prestellar core structure morphologies obtained from analysis of the Herschel-SPIRE 350 μm maps of the Lupus I cloud. This distribution is first compared on a statistical basis to the large-scale shape of the main filament. We find the distribution of the elongation position angle of the cores to be consistent with a random distribution, which means no specific orientation of themore » morphology of the cores is observed with respect to the mean orientation of the large-scale filament in Lupus I, nor relative to a large-scale bent filament model. This distribution is also compared to the mean orientation of the large-scale magnetic fields probed at 350 μm with the Balloon-borne Large Aperture Telescope for Polarimetry during its 2010 campaign. Here again we do not find any correlation between the core morphology distribution and the average orientation of the magnetic fields on parsec scales. Our main conclusion is that the local filament dynamics—including secondary filaments that often run orthogonally to the primary filament—and possibly small-scale variations in the local magnetic field direction, could be the dominant factors for explaining the final orientation of each core.« less

27 CFR 4.24 - Generic, semi-generic, and non-generic designations of geographic significance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Generic, semi-generic, and non-generic designations of geographic significance. 4.24 Section 4.24 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND...

Development of the Transport Class Model (TCM) Aircraft Simulation From a Sub-Scale Generic Transport Model (GTM) Simulation

NASA Technical Reports Server (NTRS)

Hueschen, Richard M.

2011-01-01

A six degree-of-freedom, flat-earth dynamics, non-linear, and non-proprietary aircraft simulation was developed that is representative of a generic mid-sized twin-jet transport aircraft. The simulation was developed from a non-proprietary, publicly available, subscale twin-jet transport aircraft simulation using scaling relationships and a modified aerodynamic database. The simulation has an extended aerodynamics database with aero data outside the normal transport-operating envelope (large angle-of-attack and sideslip values). The simulation has representative transport aircraft surface actuator models with variable rate-limits and generally fixed position limits. The simulation contains a generic 40,000 lb sea level thrust engine model. The engine model is a first order dynamic model with a variable time constant that changes according to simulation conditions. The simulation provides a means for interfacing a flight control system to use the simulation sensor variables and to command the surface actuators and throttle position of the engine model.

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

PubMed

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

Evaluation of health related quality of life in children with immune thrombocytopenia with the PedsQL™ 4.0 Generic Core Scales: a study on behalf of the pays de Loire pediatric hematology network.

PubMed

Strullu, Marion; Rakotonjanahary, Josué; Tarral, Eliane; Savagner, Christophe; Thomas, Caroline; Méchinaud, Françoise; Reguerre, Yves; Poignant, Sylvaine; Boutet, Arnaud; Bassil, Joachim; Médinger, Dominique; Quemener, Emmanuel; Young, Nancy L; Rachieru, Petronela; Klaassen, Robert J; Pellier, Isabelle

2013-11-13

Immune thrombocytopenia (ITP) is a childhood disorder that is often life-altering for children and their parents. Health related quality of life (HRQL) has never been chronologically monitored in children with ITP. We initiated a prospective study to assess HRQL from diagnosis to six months and define factors that influence this outcome in children with ITP. 73 children with acute ITP aged from 2 to 18 years were prospectively enrolled in the study. According to the presence of bleeding, they were or were not given a 4-day course of corticosteroid treatment. The PedsQL™ 4.0 Generic Core Scale was completed by children and parents upon their inclusion in the study and 6 months after diagnosis. Over the six month period, quality of life improved in terms of their global, physical and psychosocial well-being for 54.5%, 35.6% and 36.2% of patients respectively. This improvement is clinically relevant compared to scores at diagnosis, corresponding at least to a minimal clinically important difference (MCID). Factors such as sex, age, platelet count, bleeding scores, bone marrow aspiration and persistence of ITP at 6 months were not significantly associated with HRQL scores. However, preceding viral infection was identified to have an impact on HRQL. This first longitudinal study assessing HRQL in children with ITP reveals a global improvement in PedSQL™ 4.0. However, these results should be considered with caution since our data also confirm that self-report HRQL scores are not influenced by any analyzed biologic or clinical parameters. Others tools, such as Kids' ITP Tools, would probably be required to assess the HRQL of this population. Trial registration clinical trials.gov Identifier: NCT00331357.

Generic evolution of mixing in heterogeneous media

NASA Astrophysics Data System (ADS)

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

Classification as a generic tool for characterising status and changes of regional scale groundwater systems

NASA Astrophysics Data System (ADS)

Barthel, Roland; Haaf, Ezra

2016-04-01

Regional hydrogeology is becoming increasingly important, but at the same time, scientifically sound, universal solutions for typical groundwater problems encountered on the regional scale are hard to find. While managers, decision-makers and state agencies operating on regional and national levels have always shown a strong interest in regional scale hydrogeology, researchers from academia tend to avoid the subject, focusing instead on local scales. Additionally, hydrogeology has always had a tendency to regard every problem as unique to its own site- and problem-specific context. Regional scale hydrogeology is therefore pragmatic rather than aiming at developing generic methodology (Barthel, 2014; Barthel and Banzhaf, 2016). One of the main challenges encountered on the regional scale in hydrogeology is the extreme heterogeneity that generally increases with the size of the studied area - paired with relative data scarcity. Even in well-monitored regions of the world, groundwater observations are usually clustered, leaving large areas without any direct data. However, there are many good reasons for assessing the status and predicting the behavior of groundwater systems under conditions of global change even for those areas and aquifers without observations. This is typically done by using rather coarsely discretized and / or poorly parameterized numerical models, or by using very simplistic conceptual hydrological models that do not take into account the complex three-dimensional geological setup. Numerical models heavily rely on local data and are resource-demanding. Conceptual hydrological models only deliver reliable information on groundwater if the geology is extremely simple. In this contribution, we present an approach to derive statistically relevant information for un-monitored areas, making use of existing information from similar localities that are or have been monitored. The approach combines site-specific knowledge with conceptual assumptions on

PedsQL™ Multidimensional Fatigue Scale in sickle cell disease: feasibility, reliability, and validity.

PubMed

Panepinto, Julie A; Torres, Sylvia; Bendo, Cristiane B; McCavit, Timothy L; Dinu, Bogdan; Sherman-Bien, Sandra; Bemrich-Stolz, Christy; Varni, James W

2014-01-01

Sickle cell disease (SCD) is an inherited blood disorder characterized by a chronic hemolytic anemia that can contribute to fatigue and global cognitive impairment in patients. The study objective was to report on the feasibility, reliability, and validity of the PedsQL™ Multidimensional Fatigue Scale in SCD for pediatric patient self-report ages 5-18 years and parent proxy-report for ages 2-18 years. This was a cross-sectional multi-site study whereby 240 pediatric patients with SCD and 303 parents completed the 18-item PedsQL™ Multidimensional Fatigue Scale. Participants also completed the PedsQL™ 4.0 Generic Core Scales. The PedsQL™ Multidimensional Fatigue Scale evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.90; parent proxy-report α = 0.95), and acceptable reliability for the three individual scales (patient self-report α = 0.77-0.84; parent proxy-report α = 0.90-0.97). Intercorrelations of the PedsQL™ Multidimensional Fatigue Scale with the PedsQL™ Generic Core Scales were predominantly in the large (≥0.50) range, supporting construct validity. PedsQL™ Multidimensional Fatigue Scale Scores were significantly worse with large effects sizes (≥0.80) for patients with SCD than for a comparison sample of healthy children, supporting known-groups discriminant validity. Confirmatory factor analysis demonstrated an acceptable to excellent model fit in SCD. The PedsQL™ Multidimensional Fatigue Scale demonstrated acceptable to excellent measurement properties in SCD. The results demonstrate the relative severity of fatigue symptoms in pediatric patients with SCD, indicating the potential clinical utility of multidimensional assessment of fatigue in patients with SCD in clinical research and practice. © 2013 Wiley Periodicals, Inc.

CopperCore Service Integration

ERIC Educational Resources Information Center

Vogten, Hubert; Martens, Harrie; Nadolski, Rob; Tattersall, Colin; van Rosmalen, Peter; Koper, Rob

2007-01-01

In an e-learning environment there is a need to integrate various e-learning services like assessment services, collaboration services, learning design services and communication services. In this article we present the design and implementation of a generic integrative service framework, called CopperCore Service Integration (CCSI). We will…

Core Items for a Standardized Resource Use Measure: Expert Delphi Consensus Survey.

PubMed

Thorn, Joanna C; Brookes, Sara T; Ridyard, Colin; Riley, Ruth; Hughes, Dyfrig A; Wordsworth, Sarah; Noble, Sian M; Thornton, Gail; Hollingworth, William

2018-06-01

Resource use measurement by patient recall is characterized by inconsistent methods and a lack of validation. A validated standardized resource use measure could increase data quality, improve comparability between studies, and reduce research burden. To identify a minimum set of core resource use items that should be included in a standardized adult instrument for UK health economic evaluation from a provider perspective. Health economists with experience of UK-based economic evaluations were recruited to participate in an electronic Delphi survey. Respondents were asked to rate 60 resource use items (e.g., medication names) on a scale of 1 to 9 according to the importance of the item in a generic context. Items considered less important according to predefined consensus criteria were dropped and a second survey was developed. In the second round, respondents received the median score and their own score from round 1 for each item alongside summarized comments and were asked to rerate items. A final project team meeting was held to determine the recommended core set. Forty-five participants completed round 1. Twenty-six items were considered less important and were dropped, 34 items were retained for the second round, and no new items were added. Forty-two respondents (93.3%) completed round 2, and greater consensus was observed. After the final meeting, 10 core items were selected, with further items identified as suitable for "bolt-on" questionnaire modules. The consensus on 10 items considered important in a generic context suggests that a standardized instrument for core resource use items is feasible. Copyright © 2018. Published by Elsevier Inc.

Rank Dynamics of Word Usage at Multiple Scales

NASA Astrophysics Data System (ADS)

Morales, José A.; Colman, Ewan; Sánchez, Sergio; Sánchez-Puig, Fernanda; Pineda, Carlos; Iñiguez, Gerardo; Cocho, Germinal; Flores, Jorge; Gershenson, Carlos

2018-05-01

The recent dramatic increase in online data availability has allowed researchers to explore human culture with unprecedented detail, such as the growth and diversification of language. In particular, it provides statistical tools to explore whether word use is similar across languages, and if so, whether these generic features appear at different scales of language structure. Here we use the Google Books N-grams dataset to analyze the temporal evolution of word usage in several languages. We apply measures proposed recently to study rank dynamics, such as the diversity of N-grams in a given rank, the probability that an N-gram changes rank between successive time intervals, the rank entropy, and the rank complexity. Using different methods, results show that there are generic properties for different languages at different scales, such as a core of words necessary to minimally understand a language. We also propose a null model to explore the relevance of linguistic structure across multiple scales, concluding that N-gram statistics cannot be reduced to word statistics. We expect our results to be useful in improving text prediction algorithms, as well as in shedding light on the large-scale features of language use, beyond linguistic and cultural differences across human populations.

Investigation of Aerodynamics Scale Effects for a Generic Fighter Configuration in the National Transonic Facility (Invited)

NASA Technical Reports Server (NTRS)

Tomek, W. G.; Wahls, R. A.; Owens, L. R.; Burner, A. B.; Graves, S. S.; Luckring, J. M.

2003-01-01

Two wind tunnel tests of a generic fighter configuration have been completed in the National Transonic Facility. The primary purpose of the tests was to assess Reynolds number scale effects on a thin-wing, fighter-type configuration up to full-scale flight conditions (that is, Reynolds numbers of the order of 60 million). The tests included longitudinal and lateral/directional studies at subsonic and transonic conditions across a range of Reynolds numbers from that available in conventional wind tunnels to flight conditions. Results are presented for three Mach numbers (0.6, 0.8, and 0.9) and three configurations: 1) Fuselage / Wing, 2) Fuselage / Wing / Centerline Vertical Tail / Horizontal Tail, and 3) Fuselage / Wing / Trailing-Edge Extension / Twin Vertical Tails. Reynolds number effects on the lateral-directional aerodynamic characteristics are presented herein, along with longitudinal data demonstrating the effects of fixing the boundary layer transition location for low Reynolds number conditions. In addition, an improved model videogrammetry system and results are discussed.

Estimated generic prices for novel treatments for drug-resistant tuberculosis.

PubMed

Gotham, Dzintars; Fortunak, Joseph; Pozniak, Anton; Khoo, Saye; Cooke, Graham; Nytko, Frederick E; Hill, Andrew

2017-04-01

The estimated worldwide annual incidence of MDR-TB is 480 000, representing 5% of TB incidence, but 20% of mortality. Multiple drugs have recently been developed or repurposed for the treatment of MDR-TB. Currently, treatment for MDR-TB costs thousands of dollars per course. To estimate generic prices for novel TB drugs that would be achievable given large-scale competitive manufacture. Prices for linezolid, moxifloxacin and clofazimine were estimated based on per-kilogram prices of the active pharmaceutical ingredient (API). Other costs were added, including formulation, packaging and a profit margin. The projected costs for sutezolid were estimated to be equivalent to those for linezolid, based on chemical similarity. Generic prices for bedaquiline, delamanid and pretomanid were estimated by assessing routes of synthesis, costs/kg of chemical reagents, routes of synthesis and per-step yields. Costing algorithms reflected variable regulatory requirements and efficiency of scale based on demand, and were validated by testing predictive ability against widely available TB medicines. Estimated generic prices were US$8-$17/month for bedaquiline, $5-$16/month for delamanid, $11-$34/month for pretomanid, $4-$9/month for linezolid, $4-$9/month for sutezolid, $4-$11/month for clofazimine and $4-$8/month for moxifloxacin. The estimated generic prices were 87%-94% lower than the current lowest available prices for bedaquiline, 95%-98% for delamanid and 94%-97% for linezolid. Estimated generic prices were $168-$395 per course for the STREAM trial modified Bangladesh regimens (current costs $734-$1799), $53-$276 for pretomanid-based three-drug regimens and $238-$507 for a delamanid-based four-drug regimen. Competitive large-scale generic manufacture could allow supplies of treatment for 5-10 times more MDR-TB cases within current procurement budgets. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All

Perception of Generic Prescription Drugs and Utilization of Generic Drug Discount Programs

PubMed Central

Omojasola, Anthony; Hernandez, Mike; Sansgiry, Sujit; Jones, Lovell

2012-01-01

Objective Our study aimed to assess patient’s perceptions of generic drugs and utilization of generic drug discount programs. Design, Setting and Participants A survey was administered to adult participants at community health centers and community-based organizations in Houston, Texas, USA (n=525). Main Outcome Measures Multivariate logistic regression was used to quantify the strength of association between generic drug perception and utilization of generic drug discount programs. Results Respondents who agreed that “Generic prescription drugs are as effective as brand name prescription drugs,” were 3 times as likely to utilize generic drug discount programs (AOR: 3.0, 95% CI: 1.8–4.8, P<.001). Compared to non-Hispanic Whites, African Americans (OR: 10.2; 95% CI: 1.4–76.4) and Hispanics (OR: 10.3; 95% CI: 1.3–79.4) were 10 times as likely to agree that generic drugs have more side effects than brand name drugs. Conclusion Race/ethnicity had no impact in utilization of generic drug discount programs, despite racial disparities in perception toward generic drugs’ side effects and generic drugs being inferior to brand name drugs. PMID:23140080

Pre-Stressing Micron-Scale Aluminum Core-Shell Particles to Improve Reactivity

PubMed Central

Levitas, Valery I.; McCollum, Jena; Pantoya, Michelle

2015-01-01

The main direction in increasing reactivity of aluminum (Al) particles for energetic applications is reduction in their size down to nanoscale. However, Al nanoparticles are 30–50 times more expensive than micron scale particles and possess safety and environmental issues. Here, we improved reactivity of Al micron scale particles by synthesizing pre-stressed core-shell structures. Al particles were annealed and quenched to induce compressive stresses in the alumina passivation shell surrounding Al core. This thermal treatment was designed based on predictions of the melt-dispersion mechanism (MDM); a theory describing Al particle reaction under high heating rate. For all anneal treatment temperatures, experimental flame propagation rates for Al combined with nanoscale copper oxide (CuO) are in quantitative agreement with the theoretical predictions based on the MDM. The best treatment increases flame rate by 36% and achieves 68% of that for the best Al nanoparticles. PMID:25597747

PedsQL™ Multidimensional Fatigue Scale in Sickle Cell Disease: Feasibility, Reliability and Validity

PubMed Central

Panepinto, Julie A.; Torres, Sylvia; Bendo, Cristiane B.; McCavit, Timothy L.; Dinu, Bogdan; Sherman-Bien, Sandra; Bemrich-Stolz, Christy; Varni, James W.

2013-01-01

Background Sickle cell disease (SCD) is an inherited blood disorder characterized by a chronic hemolytic anemia that can contribute to fatigue and global cognitive impairment in patients. The study objective was to report on the feasibility, reliability, and validity of the PedsQL™ Multidimensional Fatigue Scale in SCD for pediatric patient self-report ages 5–18 years and parent proxy-report for ages 2–18 years. Procedure This was a cross-sectional multi-site study whereby 240 pediatric patients with SCD and 303 parents completed the 18-item PedsQL™ Multidimensional Fatigue Scale. Participants also completed the PedsQL™ 4.0 Generic Core Scales. Results The PedsQL™ Multidimensional Fatigue Scale evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.90; parent proxy-report α = 0.95), and acceptable reliability for the three individual scales (patient self-report α = 0.77–0.84; parent proxy-report α = 0.90–0.97). Intercorrelations of the PedsQL™ Multidimensional Fatigue Scale with the PedsQL™ Generic Core Scales were predominantly in the large (≥ 0.50) range, supporting construct validity. PedsQL™ Multidimensional Fatigue Scale Scores were significantly worse with large effects sizes (≥0.80) for patients with SCD than for a comparison sample of healthy children, supporting known-groups discriminant validity. Confirmatory factor analysis demonstrated an acceptable to excellent model fit in SCD. Conclusions The PedsQL™ Multidimensional Fatigue Scale demonstrated acceptable to excellent measurement properties in SCD. The results demonstrate the relative severity of fatigue symptoms in pediatric patients with SCD, indicating the potential clinical utility of multidimensional assessment of fatigue in patients with SCD in clinical research and practice. PMID:24038960

[Generic drug substitution].

PubMed

Tamir, Orly; Halkin, Hillel; Shemer, Joshua

2006-09-01

The rapidly rising health care expenditures, attributed mainly to the high cost of prescription drugs, have led governments around the world to look to generics as a means of containing costs in the pharmaceutical market. Generic drugs provide a less expensive alternative to brand name drugs due to the elimination of the need to perform lengthy and costly clinical trials, as required for innovative drugs. Essentially, generic substitution of drugs may be performed only after showing unequivocally that the generic formulation is identical in its active ingredients, strength, and route of administration as its innovative counterpart, and that they are bioequivalent to each other. Although the two are in essence the same, generic substitution is occasionally a controversial matter.

cm-scale variations of crystal orientation fabric in cold Alpine ice core from Colle Gnifetti

NASA Astrophysics Data System (ADS)

Kerch, Johanna; Weikusat, Ilka; Eisen, Olaf; Wagenbach, Dietmar; Erhardt, Tobias

2015-04-01

Analysis of the microstructural parameters of ice has been an important part of ice core analyses so far mainly in polar cores in order to obtain information about physical processes (e.g. deformation, recrystallisation) on the micro- and macro-scale within an ice body. More recently the influence of impurities and climatic conditions during snow accumulation on these processes has come into focus. A deeper understanding of how palaeoclimate proxies interact with physical properties of the ice matrix bears relevance for palaeoclimatic interpretations, improved geophysical measurement techniques and the furthering of ice dynamical modeling. Variations in microstructural parameters e.g. crystal orientation fabric or grain size can be observed on a scale of hundreds and tens of metres but also on a centimetre scale. The underlying processes are not necessarily the same on all scales. Especially for the short-scale variations many questions remain unanswered. We present results from a study that aims to investigate following hypotheses: 1. Variations in grain size and fabric, i.e. strong changes of the orientation of ice crystals with respect to the vertical, occur on a centimetre scale and can be observed in all depths of an ice core. 2. Palaeoclimate proxies like dust and impurities have an impact on the microstructural processes and thus are inducing the observed short-scale variations in grain size and fabric. 3. The interaction of proxies with the ice matrix leads to depth intervals that show correlating behaviour as well as ranges with anticorrelation between microstructural parameters and palaeoclimatic proxies. The respective processes need to be identified. Fabric Analyser measurements were conducted on more than 80 samples (total of 8 m) from different depth ranges of a cold Alpine ice core (72 m length) drilled in 2013 at Colle Gnifetti, Switzerland/Italy. Results were obtained by automatic image processing, providing estimates for grain size distributions

Spatial scaling of core and dominant forest cover in the Upper Mississippi and Illinois River floodplains, USA

USGS Publications Warehouse

De Jager, Nathan R.; Rohweder, Jason J.

2011-01-01

Different organisms respond to spatial structure in different terms and across different spatial scales. As a consequence, efforts to reverse habitat loss and fragmentation through strategic habitat restoration ought to account for the different habitat density and scale requirements of various taxonomic groups. Here, we estimated the local density of floodplain forest surrounding each of ~20 million 10-m forested pixels of the Upper Mississippi and Illinois River floodplains by using moving windows of multiple sizes (1–100 ha). We further identified forest pixels that met two local density thresholds: 'core' forest pixels were nested in a 100% (unfragmented) forested window and 'dominant' forest pixels were those nested in a >60% forested window. Finally, we fit two scaling functions to declines in the proportion of forest cover meeting these criteria with increasing window length for 107 management-relevant focal areas: a power function (i.e. self-similar, fractal-like scaling) and an exponential decay function (fractal dimension depends on scale). The exponential decay function consistently explained more variation in changes to the proportion of forest meeting both the 'core' and 'dominant' criteria with increasing window length than did the power function, suggesting that elevation, soil type, hydrology, and human land use constrain these forest types to a limited range of scales. To examine these scales, we transformed the decay constants to measures of the distance at which the probability of forest meeting the 'core' and 'dominant' criteria was cut in half (S 1/2, m). S 1/2 for core forest was typically between ~55 and ~95 m depending on location along the river, indicating that core forest cover is restricted to extremely fine scales. In contrast, half of all dominant forest cover was lost at scales that were typically between ~525 and 750 m, but S 1/2 was as long as 1,800 m. S 1/2 is a simple measure that (1) condenses information derived from multi-scale

Emerging Methods in Sub Core-Scale Imaging and Characterization of the Influence of Heterogeneity on Flow in Rocks (Invited)

NASA Astrophysics Data System (ADS)

Benson, S. M.; Hingerl, F.; Pini, R.

2013-12-01

New imaging techniques and approaches are providing unparalleled insight into the influence of sub-core scale heterogeneities on single and multiphase flows. Quantification of sub core-scale porosity, permeability, and even capillary pressure curves at a spatial scale of about 1-10 cubic millimeters is now possible. This scale provides a critical link in the continuum of spatial scales needed to link pore-scale processes to core-scale and field scale flow and transport. Data from such studies can be used to directly test the veracity of models for flow and transport in heterogeneous rocks, provide data for multi-stage upscaling, and reveal insights about physical/chemical processes heretofore neglected. Here we present data from three emerging techniques capable of imaging and quantifying transport properties and phenomena at the sub-core scale: magnetic resonance imaging (MRI); positron emission tomography (PET); and X-Ray CT scanning. Direct imaging of spatially resolved fluid velocities and porosity is possible with MRI (Romanenko et al., 2012). These data can be inverted to provide permeability and porosity maps at a spatial scale of ~10 cubic millimeter. PET imaging can be used to track movement of a radioactive tracer through a rock and simultaneously measure effluent tracer concentrations at a similar resolution (Boutchko et al., 2012). X-ray CT scanning of multiphase flow experiments can be used to measure capillary pressure curves and through scaling relationships, to calculate permeability at a scale of about 1 cubic millimeters(Krause et al., 2011; Pini et al., 2013). Strengths and shortcomings of these techniques are discussed--along with the benefits of combining them. Together these techniques provide a new platform from which to probe more deeply the ubiquitous influence of heterogeneity on subsurface flow and transport processes, and ultimately improve predictions of subsurface transport. Boutchk et al., 2012. Imaging and modeling of flow in porous

Customization of a generic 3D model of the distal femur using diagnostic radiographs.

PubMed

Schmutz, B; Reynolds, K J; Slavotinek, J P

2008-01-01

A method for the customization of a generic 3D model of the distal femur is presented. The customization method involves two steps: acquisition of calibrated orthogonal planar radiographs; and linear scaling of the generic model based on the width of a subject's femoral condyles as measured on the planar radiographs. Planar radiographs of seven intact lower cadaver limbs were obtained. The customized generic models were validated by comparing their surface geometry with that of CT-reconstructed reference models. The overall mean error was 1.2 mm. The results demonstrate that uniform scaling as a first step in the customization process produced a base model of accuracy comparable to other models reported in the literature.

Universal scaling relations in scale-free structure formation

NASA Astrophysics Data System (ADS)

Guszejnov, Dávid; Hopkins, Philip F.; Grudić, Michael Y.

2018-07-01

A large number of astronomical phenomena exhibit remarkably similar scaling relations. The most well-known of these is the mass distribution dN/dM ∝ M-2 which (to first order) describes stars, protostellar cores, clumps, giant molecular clouds, star clusters, and even dark matter haloes. In this paper we propose that this ubiquity is not a coincidence and that it is the generic result of scale-free structure formation where the different scales are uncorrelated. We show that all such systems produce a mass function proportional to M-2 and a column density distribution with a power-law tail of dA/dln Σ ∝ Σ-1. In the case where structure formation is controlled by gravity the two-point correlation becomes ξ2D ∝ R-1. Furthermore, structures formed by such processes (e.g. young star clusters, DM haloes) tend to a ρ ∝ R-3 density profile. We compare these predictions with observations, analytical fragmentation cascade models, semi-analytical models of gravito-turbulent fragmentation, and detailed `full physics' hydrodynamical simulations. We find that these power laws are good first-order descriptions in all cases.

Universal Scaling Relations in Scale-Free Structure Formation

NASA Astrophysics Data System (ADS)

Guszejnov, Dávid; Hopkins, Philip F.; Grudić, Michael Y.

2018-04-01

A large number of astronomical phenomena exhibit remarkably similar scaling relations. The most well-known of these is the mass distribution dN/dM∝M-2 which (to first order) describes stars, protostellar cores, clumps, giant molecular clouds, star clusters and even dark matter halos. In this paper we propose that this ubiquity is not a coincidence and that it is the generic result of scale-free structure formation where the different scales are uncorrelated. We show that all such systems produce a mass function proportional to M-2 and a column density distribution with a power law tail of dA/d lnΣ∝Σ-1. In the case where structure formation is controlled by gravity the two-point correlation becomes ξ2D∝R-1. Furthermore, structures formed by such processes (e.g. young star clusters, DM halos) tend to a ρ∝R-3 density profile. We compare these predictions with observations, analytical fragmentation cascade models, semi-analytical models of gravito-turbulent fragmentation and detailed "full physics" hydrodynamical simulations. We find that these power-laws are good first order descriptions in all cases.

Effects of generic versus non-generic feedback on motor learning in children.

PubMed

Chiviacowsky, Suzete; Drews, Ricardo

2014-01-01

Non-generic feedback refers to a specific event and implies that performance is malleable, while generic feedback implies that task performance reflects an inherent ability. The present study examined the influences of generic versus non-generic feedback on motor performance and learning in 10-year-old children. In the first experiment, using soccer ball kicking at a target as a task, providing participants with generic feedback resulted in worse performance than providing non-generic feedback, after both groups received negative feedback. The second experiment measured more permanent effects. Results of a retention test, performed one day after practicing a throwing task, showed that participants who received non-generic feedback during practice outperformed the generic feedback group, after receiving a negative feedback statement. The findings demonstrate the importance of the wording of feedback. Even though different positive feedback statements may not have an immediate influence on performance, they can affect performance, and presumably individuals' motivation, when performance is (purportedly) poor. Feedback implying that performance is malleable, rather than due to an inherent ability, seems to have the potential to inoculate learners against setbacks--a situation frequently encountered in the context of motor performance and learning.

Effects of Generic versus Non-Generic Feedback on Motor Learning in Children

PubMed Central

Chiviacowsky, Suzete; Drews, Ricardo

2014-01-01

Non-generic feedback refers to a specific event and implies that performance is malleable, while generic feedback implies that task performance reflects an inherent ability. The present study examined the influences of generic versus non-generic feedback on motor performance and learning in 10-year-old children. In the first experiment, using soccer ball kicking at a target as a task, providing participants with generic feedback resulted in worse performance than providing non-generic feedback, after both groups received negative feedback. The second experiment measured more permanent effects. Results of a retention test, performed one day after practicing a throwing task, showed that participants who received non-generic feedback during practice outperformed the generic feedback group, after receiving a negative feedback statement. The findings demonstrate the importance of the wording of feedback. Even though different positive feedback statements may not have an immediate influence on performance, they can affect performance, and presumably individuals' motivation, when performance is (purportedly) poor. Feedback implying that performance is malleable, rather than due to an inherent ability, seems to have the potential to inoculate learners against setbacks – a situation frequently encountered in the context of motor performance and learning. PMID:24523947

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

PubMed

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.

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

PubMed Central

Dohle, Simone; Siegrist, Michael

2013-01-01

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

Analysis of Monolith Cores from an Engineering Scale Demonstration of a Prospective Cast Stone Process

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

Crawford, C. L.; Cozzi, A. D.; Hill, K. A.

2016-06-01

The primary disposition path of Low Activity Waste (LAW) at the DOE Hanford Site is vitrification. A cementitious waste form is one of the alternatives being considered for the supplemental immobilization of the LAW that will not be treated by the primary vitrification facility. Washington River Protection Solutions (WRPS) has been directed to generate and collect data on cementitious or pozzolanic waste forms such as Cast Stone. This report documents the coring and leach testing of monolithic samples cored from an engineering-scale demonstration (ES Demo) with non-radioactive simulants. The ES Demo was performed at SRNL in October of 2013 usingmore » the Scaled Continuous Processing Facility (SCPF) to fill an 8.5 ft. diameter x 3.25 ft. high container with simulated Cast Stone grout. The Cast Stone formulation was chosen from the previous screening tests. Legacy salt solution from previous Hanford salt waste testing was adjusted to correspond to the average LAW composition generated from the Hanford Tank Waste Operation Simulator (HTWOS). The dry blend materials, ordinary portland cement (OPC), Class F fly ash, and ground granulated blast furnace slag (GGBFS or BFS), were obtained from Lafarge North America in Pasco, WA. In 2014 core samples originally obtained approximately six months after filling the ES Demo were tested along with bench scale molded samples that were collected during the original pour. A latter set of core samples were obtained in late March of 2015, eighteen months after completion of the original ES Demo. Core samples were obtained using a 2” diameter x 11” long coring bit. The ES Demo was sampled in three different regions consisting of an outer ring, a middle ring and an inner core zone. Cores from these three lateral zones were further segregated into upper, middle and lower vertical segments. Monolithic core samples were tested using the Environmental Protection Agency (EPA) Method 1315, which is designed to provide mass transfer

Accelerated gravity testing of aquitard core permeability and implications at formation and regional scale

NASA Astrophysics Data System (ADS)

Timms, W. A.; Crane, R.; Anderson, D. J.; Bouzalakos, S.; Whelan, M.; McGeeney, D.; Rahman, P. F.; Guinea, A.; Acworth, R. I.

2015-03-01

Evaluating the possibility of leakage through low permeability geological strata is critically important for sustainable water supplies, the extraction of fuels from strata such as coal beds, and the confinement of waste within the earth. The current work demonstrates that relatively rapid and reliable hydraulic conductivity (K) measurement of aquitard cores using accelerated gravity can inform and constrain larger scale assessments of hydraulic connectivity. Steady state fluid velocity through a low K porous sample is linearly related to accelerated gravity (g-level) in a centrifuge permeameter (CP) unless consolidation or geochemical reactions occur. The CP module was custom designed to fit a standard 2 m diameter geotechnical centrifuge (550 g maximum) with a capacity for sample dimensions of 30 to 100 mm diameter and 30 to 200 mm in length, and a maximum total stress of ~2 MPa at the base of the core. Formation fluids were used as influent to limit any shrink-swell phenomena which may alter the permeability. Vertical hydraulic conductivity (Kv) results from CP testing of cores from three sites within the same regional clayey silt formation varied (10-7 to 10-9 m s-1, n = 14). Results at one of these sites (1.1 × 10-10 to 3.5 × 10-9 m s-1, n = 5) that were obtained in < 24 h were similar to in situ Kv values (3 × 10-9 m s-1) from pore pressure responses over several weeks within a 30 m clayey sequence. Core scale and in situ Kv results were compared with vertical connectivity within a regional flow model, and considered in the context of heterogeneity and preferential flow paths at site and formation scale. More reliable assessments of leakage and solute transport though aquitards over multi-decadal timescales can be achieved by accelerated core testing together with advanced geostatistical and numerical methods.

SC'11 Poster: A Highly Efficient MGPT Implementation for LAMMPS; with Strong Scaling

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

Oppelstrup, T; Stukowski, A; Marian, J

2011-12-07

The MGPT potential has been implemented as a drop in package to the general molecular dynamics code LAMMPS. We implement an improved communication scheme that shrinks the communication layer thickness, and increases the load balancing. This results in unprecedented strong scaling, and speedup continuing beyond 1/8 atom/core. In addition, we have optimized the small matrix linear algebra with generic blocking (for all processors) and specific SIMD intrinsics for vectorization on Intel, AMD, and BlueGene CPUs.

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

PubMed

Alatawi, Y; Rahman, Md M; Cheng, N; Qian, J; Peissig, P L; Berg, R L; Page, C D; Hansen, R A

2018-06-01

Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P < .01). Inconsistent reporting patterns were observed more between brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported. © 2017 John Wiley & Sons Ltd.

Generic antibiotics in Japan.

PubMed

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

Analysis of French generic medicines retail market: why the use of generic medicines is limited.

PubMed

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2014-12-01

The market share of generic medicines in France is low compared to other European countries. This perspective paper provides an overview of the generic medicines retail market in France and how the current policy environment may affect the long-term sustainability. Looking at the French generic medicines retail market and the surrounding regulatory framework, all conditions seem to be in place to create a healthy generic medicines market: the country has well-respected regulatory authorities, generic medicines enter the market in a timely manner and prices of generic medicines are competitive compared with other European countries. Despite the success of the demand-side policies targeted at pharmacists and patients, those targeted at physicians were less successful due to a lack of enforcement and a lack of trust in generic medicines by French physicians. Recommendations to increase the use of generic medicines in France round off this perspective paper.

Large-Scale Gene Relocations following an Ancient Genome Triplication Associated with the Diversification of Core Eudicots.

PubMed

Wang, Yupeng; Ficklin, Stephen P; Wang, Xiyin; Feltus, F Alex; Paterson, Andrew H

2016-01-01

Different modes of gene duplication including whole-genome duplication (WGD), and tandem, proximal and dispersed duplications are widespread in angiosperm genomes. Small-scale, stochastic gene relocations and transposed gene duplications are widely accepted to be the primary mechanisms for the creation of dispersed duplicates. However, here we show that most surviving ancient dispersed duplicates in core eudicots originated from large-scale gene relocations within a narrow window of time following a genome triplication (γ) event that occurred in the stem lineage of core eudicots. We name these surviving ancient dispersed duplicates as relocated γ duplicates. In Arabidopsis thaliana, relocated γ, WGD and single-gene duplicates have distinct features with regard to gene functions, essentiality, and protein interactions. Relative to γ duplicates, relocated γ duplicates have higher non-synonymous substitution rates, but comparable levels of expression and regulation divergence. Thus, relocated γ duplicates should be distinguished from WGD and single-gene duplicates for evolutionary investigations. Our results suggest large-scale gene relocations following the γ event were associated with the diversification of core eudicots.

Large-Scale Gene Relocations following an Ancient Genome Triplication Associated with the Diversification of Core Eudicots

PubMed Central

Wang, Yupeng; Ficklin, Stephen P.; Wang, Xiyin; Feltus, F. Alex; Paterson, Andrew H.

2016-01-01

Different modes of gene duplication including whole-genome duplication (WGD), and tandem, proximal and dispersed duplications are widespread in angiosperm genomes. Small-scale, stochastic gene relocations and transposed gene duplications are widely accepted to be the primary mechanisms for the creation of dispersed duplicates. However, here we show that most surviving ancient dispersed duplicates in core eudicots originated from large-scale gene relocations within a narrow window of time following a genome triplication (γ) event that occurred in the stem lineage of core eudicots. We name these surviving ancient dispersed duplicates as relocated γ duplicates. In Arabidopsis thaliana, relocated γ, WGD and single-gene duplicates have distinct features with regard to gene functions, essentiality, and protein interactions. Relative to γ duplicates, relocated γ duplicates have higher non-synonymous substitution rates, but comparable levels of expression and regulation divergence. Thus, relocated γ duplicates should be distinguished from WGD and single-gene duplicates for evolutionary investigations. Our results suggest large-scale gene relocations following the γ event were associated with the diversification of core eudicots. PMID:27195960

Validation Results for Core-Scale Oil Shale Pyrolysis

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

Staten, Josh; Tiwari, Pankaj

2015-03-01

This report summarizes a study of oil shale pyrolysis at various scales and the subsequent development a model for in situ production of oil from oil shale. Oil shale from the Mahogany zone of the Green River formation was used in all experiments. Pyrolysis experiments were conducted at four scales, powdered samples (100 mesh) and core samples of 0.75”, 1” and 2.5” diameters. The batch, semibatch and continuous flow pyrolysis experiments were designed to study the effect of temperature (300°C to 500°C), heating rate (1°C/min to 10°C/min), pressure (ambient and 500 psig) and size of the sample on product formation.more » Comprehensive analyses were performed on reactants and products - liquid, gas and spent shale. These experimental studies were designed to understand the relevant coupled phenomena (reaction kinetics, heat transfer, mass transfer, thermodynamics) at multiple scales. A model for oil shale pyrolysis was developed in the COMSOL multiphysics platform. A general kinetic model was integrated with important physical and chemical phenomena that occur during pyrolysis. The secondary reactions of coking and cracking in the product phase were addressed. The multiscale experimental data generated and the models developed provide an understanding of the simultaneous effects of chemical kinetics, and heat and mass transfer on oil quality and yield. The comprehensive data collected in this study will help advance the move to large-scale in situ oil production from the pyrolysis of oil shale.« less

Conceptual Distinctions amongst Generics

ERIC Educational Resources Information Center

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

2013-01-01

Generic sentences (e.g., bare plural sentences such as "dogs have four legs" and "mosquitoes carry malaria") are used to talk about "kinds" of things. Three experiments investigated the conceptual foundations of generics as well as claims within the formal semantic approaches to generics concerning the roles of prevalence, cue validity and…

Generic Language and Judgements about Category Membership: Can Generics Highlight Properties as Central?

ERIC Educational Resources Information Center

Hollander, Michelle A.; Gelman, Susan A.; Raman, Lakshmi

2009-01-01

Many languages distinguish generic utterances (e.g., "Tigers are ferocious") from non-generic utterances (e.g., "Those tigers are ferocious"). Two studies examined how generic language specially links properties and categories. We used a novel-word extension task to ask if 4- to 5-year-old children and adults distinguish…

Ash deposits - Initiating the change from empiricism to generic engineering. Part 1: The generic approach

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

Wagoner, C.L.; Wessel, R.A.

1986-01-01

Empiricism has traditionally been used to relate laboratory and pilot-scale measurements of fuel characteristics with the design, performance, and the slagging and fouling behavior of steam generators. Currently, a new engineering approach is being evaluated. The goal is to develop and use calculations and measurements from several engineering disciplines that exceed the demonstrated limitations of present empirical techniques for predicting slagging/fouling behavior. In Part I of this paper, the generic approach to deposits and boiler performance is defined and a matrix of engineering concepts is described. General relationships are presented for assessing the effects of deposits and sootblowing on themore » real-time performance of heat transfer surfaces in pilot- and commercial-scale steam generators.« less

The generic drug user fee amendments: an economic perspective

PubMed Central

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

Micro-positron emission tomography for measuring sub-core scale single and multiphase transport parameters in porous media

NASA Astrophysics Data System (ADS)

Zahasky, Christopher; Benson, Sally M.

2018-05-01

Accurate descriptions of heterogeneity in porous media are important for understanding and modeling single phase (e.g. contaminant transport, saltwater intrusion) and multiphase (e.g. geologic carbon storage, enhanced oil recovery) transport problems. Application of medical imaging to experimentally quantify these processes has led to significant progress in material characterization and understanding fluid transport behavior at laboratory scales. While widely utilized in cancer diagnosis and management, cardiology, and neurology, positron emission tomography (PET) has had relatively limited applications in earth science. This study utilizes a small-bore micro-PET scanner to image and quantify the transport behavior of pulses of a conservative aqueous radiotracer injected during single and multiphase flow experiments in two heterogeneous Berea sandstone cores. The cores are discretized into axial-parallel streamtubes, and using the reconstructed micro-PET data, expressions are derived from spatial moment analysis for calculating sub-core tracer flux and pore water velocity. Using the flux and velocity measurements, it is possible to calculate porosity and saturation from volumetric flux balance, and calculate permeability and water relative permeability from Darcy's law. Second spatial moment analysis enables measurement of sub-core solute dispersion during both single phase and multiphase experiments. A numerical simulation model is developed to verify the assumptions of the streamtube dimension reduction technique. A variation of the reactor ratio is presented as a diagnostic metric to efficiently determine the validity of the streamtube approximation in core and column-scale experiments. This study introduces a new method to quantify sub-core permeability, relative permeability, and dispersion. These experimental and analytical methods provide a foundation for future work on experimental measurements of differences in transport behavior across scales.

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

PubMed

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).

Soil hydrophobicity - relating effects at atomic, molecular, core and national scales

NASA Astrophysics Data System (ADS)

Matthews, Peter; Doerr, Stefan; Van Keulen, Geertje; Dudley, Ed; Francis, Lewis; Whalley, Richard; Gazze, Andrea; Hallin, Ingrid; Quinn, Gerry; Sinclair, Kat; Ashton, Rhys

2016-04-01

The detrimental impacts of soil hydrophobicity include increased runoff, erosion and flooding, reduced biomass production, inefficient use of irrigation water and preferential leaching of pollutants. Its impacts may exacerbate flood risk associated with more extreme drought and precipitation events predicted with UK climate change scenarios. The UK's Natural Environment Research Council (NERC) has therefore funded a major research programme to investigate soil hydrophobicity over length scales ranging from atomic through molecular, core and landscape scale. This presentation gives an overview of the findings to date. The programme is predicated on the hypothesis that changes in soil protein abundance and localization, induced by variations in soil moisture and temperature, are crucial driving forces for transitions between hydrophobic and hydrophilic conditions at soil particle surfaces. Three soils were chosen based on the severity of hydrophobicity that can be achieved in the field: severe to extreme (Cefn Bryn, Gower, Wales), intermediate to severe (National Botanical Garden, Wales), and subcritical (Park Grass, Rothamsted Research near London). The latter is already highly characterised so was also used as a control. Hydrophobic/ hydrophilic transitions were measured from water droplet penetration times. Scientific advances in the following five areas will be described: (i) the identification of these soil proteins by proteomic methods, using a novel separation method which reduces interference by humic acids, and allows identification by ESI and MALDI TOF mass spectrometry and database searches, (ii) the examination of such proteins, which form ordered hydrophobic ridges, and measurement of their elasticity, stickiness and hydrophobicity at nano- to microscale using atomic force microscopy adapted for the rough surfaces of soil particles, (iii) the novel use of a picoliter goniometer to show hydrophobic effects at a 1 micron diameter droplet level, which

Assessing bioequivalence of generic antiepilepsy drugs.

PubMed

Krauss, Gregory L; Caffo, Brian; Chang, Yi-Ting; Hendrix, Craig W; Chuang, Kelly

2011-08-01

Patients with epilepsy are often concerned that switching between brand-name and generic formulations of antiepilepsy drugs (AEDs) may cause clinically significant changes in plasma drug concentrations. We assessed bioequivalence (BE) studies for approved generic AEDs to evaluate US Food and Drug Administration claims that: (1) generic AEDs are accurate copies of reference formulations; (2) delivery of reference formulations may be as variable as generic AEDs and so provide no increased benefit; and (3) switches between generic AED formulations are safe and effective. We determined differences in 90% confidence interval limits for total drug exposure (AUC(0-t) ) and peak concentration (Cmax) ratios of generic and reference formulations during fasting and fed BE studies. We simulated BE between generic formulations after adjusting for reference values. AUC(0-t) values of approved reference and generic formulations differed by <15% in 99% of BE studies; Cmax differed by <15% in 89% of studies. Food affected variability of Cmax but not AUC(0-t) . Intersubject variability in Cmax and AUC(0-t) was small and similar for reference and generic products. In simulated switches between 595 pairs of generic AED formulations, estimated AUC(0-t) differed by >15% for 17% of pairs; estimated Cmax differed by >15% for 39%. AEDs with low bioavailability and solubility (eg, oxcarbazepine) had the greatest variability in BE. Most generic AED products provide total drug delivery (AUC) similar to reference products; differences in peak concentrations between formulations are more common. Switches between generic AED products may cause greater changes in plasma drug concentrations than generic substitutions of reference products. Copyright © 2011 American Neurological Association.

A LabVIEW® based generic CT scanner control software platform.

PubMed

Dierick, M; Van Loo, D; Masschaele, B; Boone, M; Van Hoorebeke, L

2010-01-01

UGCT, the Centre for X-ray tomography at Ghent University (Belgium) does research on X-ray tomography and its applications. This includes the development and construction of state-of-the-art CT scanners for scientific research. Because these scanners are built for very different purposes they differ considerably in their physical implementations. However, they all share common principle functionality. In this context a generic software platform was developed using LabVIEW® in order to provide the same interface and functionality on all scanners. This article describes the concept and features of this software, and its potential for tomography in a research setting. The core concept is to rigorously separate the abstract operation of a CT scanner from its actual physical configuration. This separation is achieved by implementing a sender-listener architecture. The advantages are that the resulting software platform is generic, scalable, highly efficient, easy to develop and to extend, and that it can be deployed on future scanners with minimal effort.

The effect of small- and core-scale heterogeneity on the multiphase flow properties of CO2 and water in sandstones

NASA Astrophysics Data System (ADS)

Pini, R.; Benson, S. M.

2012-12-01

Capillary pressure and relative permeability functions are characteristic curves that, when coupled to the continuum-scale equations of motion, allow for a description of multiphase displacement processes in porous media. Traditionally, these properties are measured in the laboratory and are implemented into reservoir simulations to predict the behavior at the field-scale. There is an increasing awareness that detailed investigations are required to understand the role of the inherent heterogeneity of the rock samples used in the experiments on the measured multiphase properties. In fact, although a significant amount of simulation work has explored the effect of heterogeneities on Pc-kr-S relationships, very few experimental studies report on displacements with well-characterized, naturally heterogeneous media. To extend the current data set and to support these numerical findings, more laboratory data are therefore required that have been obtained under a variety of conditions and on cores from different geological settings. A direct practical implication of these studies would be the definition of a minimum scale at which heterogeneities have to be resolved, so that mathematical models would adequately capture the observed displacement patterns. Moreover, the coupling of experiments and theory will serve as a firm starting point for testing scale-up methods. In this study, results from core-flooding experiments are presented that have been carried out at representative conditions on a variety of naturally heterogeneous core samples. Results are presented from a newly developed technique that allows measuring drainage capillary pressure curves during core-flooding experiments; data have been collected at different temperature (25 and 50C), at different pressures (2 and 9MPa) and with different fluid pairs (CO2/water, N2/water and CO2/brine), thus showing the applicability of the novel technique in a wide range of interfacial tension levels. Additionally, Pc

Main steam-line break core shroud loading calculations for BWRs

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

Shoop, U.; Feltus, M.A.; Baratta, A.J.

1995-12-31

In July 1994, the U.S. Nuclear regulatory Commission sent out Generic Letter 94-03 to all boiling water reactors in the United States, informing them of intergranular stress corrosion cracking of core shrouds found in 2 reactors. The letter directed all to perform safety analysis of the BWR units. Penn State performed scoping calculations to determine the forces experienced by the core shroud during a main-stream line break transient.

Cross-cultural validation of the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™) generic core scale into Arabic language.

PubMed

Arabiat, Diana; Elliott, Barbara; Draper, Peter; Al Jabery, Mohammad

2011-12-01

A range of scales is available to measure health-related quality of life. Recently, established quality of life scales have been translated for use in a wide range of Western and non-Western cultures. One of the most widely used health-related quality of life scales for use with children is the PedsQL™ 4.0. In this paper, we describe the process of translating this scale into Arabic and establishing its reliability and validity. This paper has three aims: first, to explain the process of translating the PedsQL™ (4.0) self- and proxy-reports for the ages 8-12 and 13-18, from English into Arabic; second, to assess the reliability of the new Arabic version of the scale and third, to assess its validity. The scale was translated from English to Arabic and back-translated to ensure accuracy. The Arabic version was administered to healthy children and those with cancer and a range of chronic illnesses in Jordan. Statistical methods were used to test the psychometric properties (reliability and validity) of the Arabic version of the PedsQL™ (4.0) and its ability to discriminate between children in the above groups. Cronbach's alpha coefficients for child self- and parent proxy-reports exceeded 0.7 for the total scores, health summary scores and psychological health summary scores. Testing for discriminant validity showed that the healthy (control) group had a higher health-related quality of life than children and young people with cancer and chronic illness. The children with chronic illnesses had the lowest scores for physical, emotional and school functioning. Initial testing of the Arabic version of the PedsQL™ (4.0) suggests that the scale has satisfactory psychometric properties. © 2011 The Authors. Scandinavian Journal of Caring Sciences © 2011 Nordic College of Caring Science.

Can the generic antiretroviral industry support access to a universal antiretroviral regimen?

PubMed

Amole, Carolyn D; Middlecote, Caroline; Prabhu, Vineet R; Kumarasamy, N

2017-07-01

The generic antiretroviral (ARV) industry played a critical role in the massive scale-up of HIV treatment in low-income and middle-income countries since 2000. As the global community looks ahead to a universal antiretroviral regimen, this article considers the industry's role in supporting universal access to affordable, simpler, more durable, and tolerable HIV treatment regimens. Generic manufacturers made treatment scale-up in low-income and middle-income countries possible through reducing prices, combining molecules from different originator companies to develop optimal fixed-dose combinations, and investing in production capacity to meet escalating demand. Achieving scale-up of a universal regimen will require continued partnership in these areas. Collaboration on the demand and supply sides of the ARV marketplace will be required to foster a healthy and sustainable marketplace for new regimens. This includes clear priority setting from the global treatment community on priority products; predictable demand; regulatory prioritization of optimal products; effective tendering and procurement practices that enable multiple suppliers to participate in the market; coordinated product introduction efforts between Ministries of Health, partners, and civil society; and transparency from both buyers and suppliers to promote and monitor supply security. New regimens will benefit people living with HIV, as well as buyers and generic suppliers, by maximizing existing production capacity and treatment budgets to reach the 90-90-90 goals.

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

PubMed

Kolko, Miriam; Koch Jensen, Peter

2017-06-01

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

Power Laws, Scale Invariance and the Generalized Frobenius Series:

NASA Astrophysics Data System (ADS)

Visser, Matt; Yunes, Nicolas

We present a self-contained formalism for calculating the background solution, the linearized solutions and a class of generalized Frobenius-like solutions to a system of scale-invariant differential equations. We first cast the scale-invariant model into its equidimensional and autonomous forms, find its fixed points, and then obtain power-law background solutions. After linearizing about these fixed points, we find a second linearized solution, which provides a distinct collection of power laws characterizing the deviations from the fixed point. We prove that generically there will be a region surrounding the fixed point in which the complete general solution can be represented as a generalized Frobenius-like power series with exponents that are integer multiples of the exponents arising in the linearized problem. While discussions of the linearized system are common, and one can often find a discussion of power-series with integer exponents, power series with irrational (indeed complex) exponents are much rarer in the extant literature. The Frobenius-like series we encounter can be viewed as a variant of the rarely-discussed Liapunov expansion theorem (not to be confused with the more commonly encountered Liapunov functions and Liapunov exponents). As specific examples we apply these ideas to Newtonian and relativistic isothermal stars and construct two separate power series with the overlapping radius of convergence. The second of these power series solutions represents an expansion around "spatial infinity," and in realistic models it is this second power series that gives information about the stellar core, and the damped oscillations in core mass and core radius as the central pressure goes to infinity. The power-series solutions we obtain extend classical results; as exemplified for instance by the work of Lane, Emden, and Chandrasekhar in the Newtonian case, and that of Harrison, Thorne, Wakano, and Wheeler in the relativistic case. We also indicate how to

Two-year-olds use the generic/non-generic distinction to guide their inferences about novel kinds

PubMed Central

Graham, Susan A.; Nayer, Samantha L.; Gelman, Susan A.

2011-01-01

These studies investigated 24- and 30-month-olds’ sensitivity to generic versus nongeneric language when acquiring knowledge about novel kinds. Toddlers were administered an inductive inference task, during which they heard a generic noun-phrase (e.g., “Blicks drink milk”) or a non-generic noun-phrase (e.g., “This blick drinks milk”) paired with an action (e.g., drinking) modeled on an object. They were then provided with the model and a non-model exemplar and asked to imitate the action. After hearing non-generic phrases, 30-month-olds, but not 24-month-olds, imitated more often with the model than with the non-model exemplar. In contrast, after hearing generic phrases, 30-month-olds imitated equally often with both exemplars. These results suggest that 30-month-olds use the generic/non-generic distinction to guide their inferences about novel kinds. PMID:21410928

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

PubMed

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

The Destabilization of Protected Soil Organic Carbon Following Experimental Drought at the Pore and Core scale

NASA Astrophysics Data System (ADS)

Smith, A. P.; Bond-Lamberty, B. P.; Tfaily, M. M.; Todd-Brown, K. E.; Bailey, V. L.

2015-12-01

The movement of water and solutes through the pore matrix controls the distribution and transformation of carbon (C) in soils. Thus, a change in the hydrologic connectivity, such as increased saturation, disturbance or drought, may alter C mineralization and greenhouse gas (GHG) fluxes to the atmosphere. While these processes occur at the pore scale, they are often investigated at coarser scale. This project investigates pore- and core-scale soil C dynamics with varying hydrologic factors (simulated precipitation, groundwater-led saturation, and drought) to assess how climate-change induced shifts in hydrologic connectivity influences the destabilization of protected C in soils. Surface soil cores (0-15 cm depth) were collected from the Disney Wilderness Preserve, Florida, USA where water dynamics, particularly water table rise and fall, appear to exert a strong control on the emissions of GHGs and the persistence of soil organic matter in these soils. We measured CO2 and CH4 from soils allowed to freely imbibe water from below to a steady state starting from either field moist conditions or following experimental drought. Parallel treatments included the addition of similar quantities of water from above to simulate precipitation. Overall respiration increased in soil cores subjected to drought compared to field moist cores independent of wetting type. Cumulative CH4 production was higher in drought-induced soils, especially in the soils subjected to experimental groundwater-led saturation. Overall, the more C (from CO2 and CH4) was lost in drought-induced soils compared to field moist cores. Our results indicate that future drought events could have profound effects on the destabilization of protected C, especially in groundwater-fed soils. Our next steps focus on how to accurately capture drought-induced C destabilization mechanisms in earth system models.

Generic Example Proving Criteria for All

ERIC Educational Resources Information Center

Yopp, David; Ely, Rob; Johnson­-Leung, Jennifer

2015-01-01

We review literature that discusses generic example proving and highlight ambiguities that pervade our research community's discourse about generic example arguments. We distinguish between pedagogical advice for choosing good examples that can serve as generic examples when teaching and advice for developing generic example arguments. We provide…

Initial validation of the Argentinean Spanish version of the PedsQL 4.0 Generic Core Scales in children and adolescents with chronic diseases: acceptability and comprehensibility in low-income settings.

PubMed

Roizen, Mariana; Rodríguez, Susana; Bauer, Gabriela; Medin, Gabriela; Bevilacqua, Silvina; Varni, James W; Dussel, Veronica

2008-08-07

To validate the Argentinean Spanish version of the PedsQL 4.0 Generic Core Scales in Argentinean children and adolescents with chronic conditions and to assess the impact of socio-demographic characteristics on the instrument's comprehensibility and acceptability. Reliability, and known-groups, and convergent validity were tested. Consecutive sample of 287 children with chronic conditions and 105 healthy children, ages 2-18, and their parents. Chronically ill children were: (1) attending outpatient clinics and (2) had one of the following diagnoses: stem cell transplant, chronic obstructive pulmonary disease, HIV/AIDS, cancer, end stage renal disease, complex congenital cardiopathy. Patients and adult proxies completed the PedsQL 4.0 and an overall health status assessment. Physicians were asked to rate degree of health status impairment. The PedsQL 4.0 was feasible (only 9 children, all 5 to 7 year-olds, could not complete the instrument), easy to administer, completed without, or with minimal, help by most children and parents, and required a brief administration time (average 5-6 minutes). People living below the poverty line and/or low literacy needed more help to complete the instrument. Cronbach Alpha's internal consistency values for the total and subscale scores exceeded 0.70 for self-reports of children over 8 years-old and parent-reports of children over 5 years of age. Reliability of proxy-reports of 2-4 year-olds was low but improved when school items were excluded. Internal consistency for 5-7 year-olds was low (alpha range = 0.28-0.76). Construct validity was good. Child self-report and parent proxy-report PedsQL 4.0 scores were moderately but significantly correlated (rho = 0.39, p < 0.0001) and both significantly correlated with physician's assessment of health impairment and with child self-reported overall health status. The PedsQL 4.0 discriminated between healthy and chronically ill children (72.72 and 66.87, for healthy and ill children

Advertising and generic market entry.

PubMed

Königbauer, Ingrid

2007-03-01

The effect of purely persuasive advertising on generic market entry and social welfare is analysed. An incumbent has the possibility to invest in advertising which affects the prescribing physician's perceived relative qualities of the brand-name and the generic version of the drug. Advertising creates product differentiation and can induce generic market entry which is deterred without differentiation due to strong Bertrand competition. However, over-investment in advertising can deter generic market entry under certain conditions and reduces welfare as compared to accommodated market entry.

The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy.

PubMed

Löfgren, Hans

2007-06-01

This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products.

Fuel cell performance of palladium-platinum core-shell electrocatalysts synthesized in gram-scale batches

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

Khateeb, Siddique; Su, Dong; Guerreo, Sandra

This article presents the performance of palladium-platinum core-shell catalysts (Pt/Pd/C) for oxygen reduction synthesized in gram-scale batches in both liquid cells and polymer-electrolyte membrane fuel cells. Core-shell catalyst synthesis and characterization, ink fabrication, and cell assembly details are discussed. The Pt mass activity of the Pt/Pd core-shell catalyst was 0.95 A mg –1 at 0.9 V measured in liquid cells (0.1 M HClO4), which was 4.8 times higher than a commercial Pt/C catalyst. The performances of Pt/Pd/C and Pt/C in large single cells (315 cm 2) were assessed under various operating conditions. The core-shell catalyst showed consistently higher performance thanmore » commercial Pt/C in fuel cell testing. A 20–60 mV improvement across the whole current density range was observed on air. Sensitivities to temperature, humidity, and gas composition were also investigated and the core-shell catalyst showed a consistent benefit over Pt under all conditions. However, the 4.8 times activity enhancement predicated by liquid cell measurements was not fully realized in fuel cells.« less

Fuel cell performance of palladium-platinum core-shell electrocatalysts synthesized in gram-scale batches

DOE PAGES

Khateeb, Siddique; Su, Dong; Guerreo, Sandra; ...

2016-05-03

This article presents the performance of palladium-platinum core-shell catalysts (Pt/Pd/C) for oxygen reduction synthesized in gram-scale batches in both liquid cells and polymer-electrolyte membrane fuel cells. Core-shell catalyst synthesis and characterization, ink fabrication, and cell assembly details are discussed. The Pt mass activity of the Pt/Pd core-shell catalyst was 0.95 A mg –1 at 0.9 V measured in liquid cells (0.1 M HClO4), which was 4.8 times higher than a commercial Pt/C catalyst. The performances of Pt/Pd/C and Pt/C in large single cells (315 cm 2) were assessed under various operating conditions. The core-shell catalyst showed consistently higher performance thanmore » commercial Pt/C in fuel cell testing. A 20–60 mV improvement across the whole current density range was observed on air. Sensitivities to temperature, humidity, and gas composition were also investigated and the core-shell catalyst showed a consistent benefit over Pt under all conditions. However, the 4.8 times activity enhancement predicated by liquid cell measurements was not fully realized in fuel cells.« less

A Generic Ground Framework for Image Expertise Centres and Small-Sized Production Centres

NASA Astrophysics Data System (ADS)

Sellé, A.

2009-05-01

Initiated by the Pleiadas Earth Observation Program, the CNES (French Space Agency) has developed a generic collaborative framework for its image quality centre, highly customisable for any upcoming expertise centre. This collaborative framework has been design to be used by a group of experts or scientists that want to share data and processings and manage interfaces with external entities. Its flexible and scalable architecture complies with the core requirements: defining a user data model with no impact on the software (generic access data), integrating user processings with a GUI builder and built-in APIs, and offering a scalable architecture to fit any preformance requirement and accompany growing projects. The CNES jas given licensing grants for two software companies that will be able to redistribute this framework to any customer.

Centennial-scale records of total organic carbon in sediment cores from the South Yellow Sea, China

NASA Astrophysics Data System (ADS)

Zhu, Qing; Lin, Jia; Hong, Yuehui; Yuan, Lirong; Liu, Jinzhong; Xu, Xiaoming; Wang, Jianghai

2018-01-01

Global carbon cycling is a significant factor that controls climate change. The centennial-scale variations in total organic carbon (TOC) contents and its sources in marginal sea sediments may reflect the influence of human activities on global climate change. In this study, two fine-grained sediment cores from the Yellow Sea Cold Water Mass of the South Yellow Sea were used to systematically determine TOC contents and stable carbon isotope ratios. These results were combined with previous data of black carbon and 210Pb dating from which we reconstructed the centennial-scale initial sequences of TOC, terrigenous TOC (TOCter) and marine autogenous TOC (TOCmar) after selecting suitable models to correct the measured TOC (TOCcor). These sequences showed that the TOCter decreased with time in the both cores while the TOCmar increased, particularly the rapid growth in core H43 since the late 1960s. According to the correlation between the Huanghe (Yellow) River discharge and the TOCcor, TOCter, or TOCmar, we found that the TOCter in the two cores mainly derived from the Huanghe River and was transported by it, and that higher Huanghe River discharge could strengthen the decomposition of TOCmar. The newly obtained initial TOC sequences provide important insights into the interaction between human activities and natural processes.

Encouraging generic use can yield significant savings.

PubMed

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.

Generic Airspace Survey

NASA Technical Reports Server (NTRS)

Mogford, Richard H.; Bridges, Wayne; Gujarl, Vimmy; Lee, Paul U.; Preston, William

2013-01-01

This paper reports on an extension of generic airspace research to explore the amount of memorization and specialized skills required to manage sectors with specific characteristics or factors. Fifty-five retired controllers were given an electronic survey where they rated the amount of memorization or specialized skills needed for sixteen generic airspace factors. The results suggested similarities in the pattern of ratings between different areas of the US (East, Central, and West). The average of the ratings for each area also showed some differences between regions, with ratings being generally higher in the East area. All sixteen factors were rated as moderately to highly important and may be useful for future research on generic airspace, air traffic controller workload, etc.

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

[Intention of purchasing generic prescription drugs on the part of consumers in Asturias, Spain].

PubMed

González Hernando, Santiago; González Mieres, Celina; Díaz Martín, Ana M

2003-01-01

Ascertaining how consumers perceive the risk related to the use of generic prescription drugs and those factors which have the greatest impact on the intention to request a generic drug from the prescribing physician and/or the pharmacist for the purpose of determining any possible barriers or hindrances to the acceptance of generics and to gather information to aid healthcare managers in their decision-making processes. Study on prescription drug use revolving around the degree to which patients are willing to request an EFG. In this quantitative transversal study, a total of 542 individuals were individually surveyed upon exiting a healthcare center or pharmacy in Asturias. A scale for measuring the perceived risk involved in the purchase of a prescription drug including 15 attributes grouped into five aspects was included in the questionnaire. Information was also gathered regarding the intention of using generic prescription drugs and on the demographic and socioeconomic characteristics of those surveyed. For the analysis of the results, a factorial confirmational analysis, multiple regression and univariate analysis were used. The data was processed using the EQS and SPSS statistics programs. Mean perception of the risk (scales 1-7): functional: 2.75; physical: 2.68: financial: 2.19; psychological: 1.99; social: 1.42. Factors having a bearing on the intention of requesting generic prescription drugs from their physician: psychological risk (p = 0.000). On requesting the same from their pharmacist: psychological risk (p = 0.000) and social risk (p = 0.020). The agents interested in the development on the EFG market should target their communication efforts on putting the functional and financial aspects of the manufacturer's specialties and generic specialties on the same level, but should not leave out psychological and social aspects of the consumers' purchasing behavior.

INL Generic Robot Architecture

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

2005-03-30

The INL Generic Robot Architecture is a generic, extensible software framework that can be applied across a variety of different robot geometries, sensor suites and low-level proprietary control application programming interfaces (e.g. mobility, aria, aware, player, etc.).

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

PubMed

Olsson, Erika; Kälvemark Sporrong, Sofia

2012-12-01

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

Generics Pricing: The Greek Paradox.

PubMed

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.

Authorized generic drugs, price competition, and consumers' welfare.

PubMed

Berndt, Ernst R; Mortimer, Richard; Bhattacharjya, Ashoke; Parece, Andrew; Tuttle, Edward

2007-01-01

The growing frequency of authorized generics has important implications for the welfare of prescription drug consumers. Authorized generic entry could affect the timing of generic entry, brand-name and generic prices, and generic penetration. We reviewed 1999-2003 data and found that generic entry in the absence of short-run exclusivity restrictions benefits consumers through lower short-run prices. We suggest that these benefits likely also result from authorized generics. We posit that long-run prices and shares are likely essentially unaffected by authorized generics and that potential costs to consumers from any delayed generic entry are likely small.

The Generic Resolution Advisor and Conflict Evaluator (GRACE) for Detect-And-Avoid Systems

NASA Technical Reports Server (NTRS)

Abramson, Michael; Refai, Mohamad; Santiago, Confesor

2017-01-01

Java Architecture for Detect-And-Avoid (DAA) Extensibility and Modeling (JADEM) was developed at NASA Ames Research Center as a research and modeling tool for Unmanned Aircraft Systems (UAS) Integration in the National Airspace System (NAS). UAS will be required to have DAA systems in order to fulfill the regulatory requirement to remain well clear'' of other traffic. JADEM supports research on technological requirements and Minimum Operational Performance Standards (MOPS) for UAS DAA systems by providing a flexible and extensible software platform that includes models and algorithms for all major DAA functions. This paper describes one of these algorithms, the Generic Resolution Advisor and Conflict Evaluator (GRACE). GRACE supports two core DAA functions: threat evaluation and guidance. GRACE is generic in the sense that it is designed to work with any aircraft or sensor type (both cooperative and non-cooperative), and to be used in various applications and DAA guidance concepts, thus supporting evolving MOPS requirements and research. GRACE combines flexibility, robustness, and computational efficiency. It has modest memory requirements and can handle multiple cooperative and noncooperative intruders. GRACE has been used as a core JADEM component in several real-time and fast-time experiments, including human-in-the-loop simulations and live flight tests.

The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy

PubMed Central

Löfgren, Hans

2007-01-01

This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products. PMID:17543115

A Rasch scaling validation of a 'core' near-death experience.

PubMed

Lange, Rense; Greyson, Bruce; Houran, James

2004-05-01

For those with true near-death experiences (NDEs), Greyson's (1983, 1990) NDE Scale satisfactorily fits the Rasch rating scale model, thus yielding a unidimensional measure with interval-level scaling properties. With increasing intensity, NDEs reflect peace, joy and harmony, followed by insight and mystical or religious experiences, while the most intense NDEs involve an awareness of things occurring in a different place or time. The semantics of this variable are invariant across True-NDErs' gender, current age, age at time of NDE, and latency and intensity of the NDE, thus identifying NDEs as 'core' experiences whose meaning is unaffected by external variables, regardless of variations in NDEs' intensity. Significant qualitative and quantitative differences were observed between True-NDErs and other respondent groups, mostly revolving around the differential emphasis on paranormal/mystical/religious experiences vs. standard reactions to threat. The findings further suggest that False-Positive respondents reinterpret other profound psychological states as NDEs. Accordingly, the Rasch validation of the typology proposed by Greyson (1983) also provides new insights into previous research, including the possibility of embellishment over time (as indicated by the finding of positive, as well as negative, latency effects) and the potential roles of religious affiliation and religiosity (as indicated by the qualitative differences surrounding paranormal/mystical/religious issues).

Generic substitution of antiepileptic drugs.

PubMed

Sander, Josemir W; Ryvlin, Philippe; Stefan, Hermann; Booth, Daniel R; Bauer, Jürgen

2010-12-01

Substitution of antiepileptic drugs with generic formulations may affect individual people, as well as healthcare systems. Analyses of large medical claims databases suggest that generic substitution of antiepileptic drugs is associated with increased morbidity and greater use of healthcare resources. While a single brand-to-generic switch may be associated with a slight increase in overall medical costs, multiple switches may be associated with higher costs, perhaps because different generic agents are not required to be bioequivalent to each other. Generic substitution also affects the individual: along with the possible increased risk of seizures or adverse events, inconsistency of supply may make the medication appear unfamiliar, thus discouraging adherence. Importantly, substitution is often carried out at the dispensing level, without the knowledge or consent of physicians and affected individuals. Therefore, regulatory and professional bodies advocate that substitution should not be carried out without specific counseling of the individual by healthcare professionals on the details and implications of the change.

Patient-reported outcome measures in reconstructive breast surgery: is there a role for generic measures?

PubMed

Korus, Lisa J; Cypel, Tatiana; Zhong, Toni; Wu, Albert W

2015-03-01

Patient-reported outcomes provide an invaluable tool in the assessment of outcomes in plastic surgery. Traditionally, patient-reported outcomes have consisted of either generic or ad hoc measures; however, more recently, there has been interest in formally constructed and validated questionnaires that are specifically designed for a particular patient population. The purpose of this systematic review was to determine whether generic measures still have a role in the evaluation of breast reconstruction outcomes, given the recent popularity and push for use of specific measures. A systematic review was performed to identify all articles using patient-reported outcomes in the assessment of postmastectomy breast reconstruction. Frequency of use was tabulated and the most frequently used tools were assessed for success of use, using criteria described previously by the Medical Outcomes Trust. To date, the most frequently used measures are still generic measures. The 36-Item Short-Form Health Survey was the most frequently used and most successfully applied showing evidence of responsiveness in multiple settings. Other measures such as the Hospital Anxiety and Depression Scale, the Hopwood Body Image Scale, and the Rosenberg Self-Esteem Scale were able to show responsiveness in certain settings but lacked evidence as universal tools for the assessment of outcomes in reconstructive breast surgery. Despite the recent advent of measures designed specifically to assess patient-reported outcomes in the breast reconstruction population, there still appears to be a role for the use of generic instruments. Many of these tools would benefit from undergoing formal validation in the breast reconstruction population.

Generic robot architecture

DOEpatents

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.

Seasonal-Scale Dating of a Shallow Ice Core From Greenland Using Oxygen Isotope Matching Between Data and Simulation

NASA Astrophysics Data System (ADS)

Furukawa, Ryoto; Uemura, Ryu; Fujita, Koji; Sjolte, Jesper; Yoshimura, Kei; Matoba, Sumito; Iizuka, Yoshinori

2017-10-01

A precise age scale based on annual layer counting is essential for investigating past environmental changes from ice core records. However, subannual scale dating is hampered by the irregular intraannual variabilities of oxygen isotope (δ18O) records. Here we propose a dating method based on matching the δ18O variations between ice core records and records simulated by isotope-enabled climate models. We applied this method to a new δ18O record from an ice core obtained from a dome site in southeast Greenland. The close similarity between the δ18O records from the ice core and models enables correlation and the production of a precise age scale, with an accuracy of a few months. A missing δ18O minimum in the 1995/1996 winter is an example of an indistinct δ18O seasonal cycle. Our analysis suggests that the missing δ18O minimum is likely caused by a combination of warm air temperature, weak moisture transport, and cool ocean temperature. Based on the age scale, the average accumulation rate from 1960 to 2014 is reconstructed as 1.02 m yr-1 in water equivalent. The annual accumulation rate shows an increasing trend with a slope of 3.6 mm yr-1, which is mainly caused by the increase in the autumn accumulation rate of 2.6 mm yr-1. This increase is likely linked to the enhanced hydrological cycle caused by the decrease in Arctic sea ice area. Unlike the strong seasonality of precipitation amount in the ERA reanalysis data in the southeast dome region, our reconstructed accumulation rate suggests a weak seasonality.

Patients' perceptions of generic drugs in Greece.

PubMed

Skaltsas, Leonora N; Vasileiou, Konstantinos Z

2015-11-01

The use of generic drugs is growing increasingly around the world and in Greece, in particular, in order to reduce pharmaceutical expenditure. However, patients' perceptions and attitudes about generics have only partially been studied so far in Greece. This study aimed to examine the factors that influence the attitude of patients and consumers regarding generic drugs. A questionnaire survey of 364 patients visiting a pharmacy was conducted. The questionnaire consisted of 29 questions, including questions regarding their knowledge about generics, the reasons for using them, their previous experience, their willingness for generic substitution, and the factors behind these choices. Nearly half of the participants in the survey know the term 'generic' and that it has a lower price compared to the brand name drug. Their views on safety and efficacy vary significantly and the main source of information on generics is the media and the internet. The lack of knowledge is the main barrier for attitudes of doctors. Health professionals play the most influential role for the substitution of a branded drug by a generic, followed by the cost of the generic. Almost half of the patients know about generic drugs, with their lower price being the most popular feature which most patients are familiar with. It seems that primarily the doctor and, subsequently the pharmacist play the most important role in a patient's decision to replace his/her medicine with a generic. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Generic phytosanitary irradiation treatments

USDA-ARS?s Scientific Manuscript database

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 Zeala...

Initial validation of the Argentinean Spanish version of the PedsQL™ 4.0 Generic Core Scales in children and adolescents with chronic diseases: acceptability and comprehensibility in low-income settings

PubMed Central

Roizen, Mariana; Rodríguez, Susana; Bauer, Gabriela; Medin, Gabriela; Bevilacqua, Silvina; Varni, James W; Dussel, Veronica

2008-01-01

Background To validate the Argentinean Spanish version of the PedsQL™ 4.0 Generic Core Scales in Argentinean children and adolescents with chronic conditions and to assess the impact of socio-demographic characteristics on the instrument's comprehensibility and acceptability. Reliability, and known-groups, and convergent validity were tested. Methods Consecutive sample of 287 children with chronic conditions and 105 healthy children, ages 2–18, and their parents. Chronically ill children were: (1) attending outpatient clinics and (2) had one of the following diagnoses: stem cell transplant, chronic obstructive pulmonary disease, HIV/AIDS, cancer, end stage renal disease, complex congenital cardiopathy. Patients and adult proxies completed the PedsQL™ 4.0 and an overall health status assessment. Physicians were asked to rate degree of health status impairment. Results The PedsQL™ 4.0 was feasible (only 9 children, all 5 to 7 year-olds, could not complete the instrument), easy to administer, completed without, or with minimal, help by most children and parents, and required a brief administration time (average 5–6 minutes). People living below the poverty line and/or low literacy needed more help to complete the instrument. Cronbach Alpha's internal consistency values for the total and subscale scores exceeded 0.70 for self-reports of children over 8 years-old and parent-reports of children over 5 years of age. Reliability of proxy-reports of 2–4 year-olds was low but improved when school items were excluded. Internal consistency for 5–7 year-olds was low (α range = 0.28–0.76). Construct validity was good. Child self-report and parent proxy-report PedsQL™ 4.0 scores were moderately but significantly correlated (ρ = 0.39, p < 0.0001) and both significantly correlated with physician's assessment of health impairment and with child self-reported overall health status. The PedsQL™ 4.0 discriminated between healthy and chronically ill children (72

Infrared length scale and extrapolations for the no-core shell model

DOE PAGES

Wendt, K. A.; Forssén, C.; Papenbrock, T.; ...

2015-06-03

In this paper, we precisely determine the infrared (IR) length scale of the no-core shell model (NCSM). In the NCSM, the A-body Hilbert space is truncated by the total energy, and the IR length can be determined by equating the intrinsic kinetic energy of A nucleons in the NCSM space to that of A nucleons in a 3(A-1)-dimensional hyper-radial well with a Dirichlet boundary condition for the hyper radius. We demonstrate that this procedure indeed yields a very precise IR length by performing large-scale NCSM calculations for 6Li. We apply our result and perform accurate IR extrapolations for bound statesmore » of 4He, 6He, 6Li, and 7Li. Finally, we also attempt to extrapolate NCSM results for 10B and 16O with bare interactions from chiral effective field theory over tens of MeV.« less

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 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...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 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...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 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...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2010 CFR

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...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 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 Kalman Filter Software

NASA Technical Reports Server (NTRS)

Lisano, Michael E., II; Crues, Edwin Z.

2005-01-01

The Generic Kalman Filter (GKF) software provides a standard basis for the development of application-specific Kalman-filter programs. Historically, Kalman filters have been implemented by customized programs that must be written, coded, and debugged anew for each unique application, then tested and tuned with simulated or actual measurement data. Total development times for typical Kalman-filter application programs have ranged from months to weeks. The GKF software can simplify the development process and reduce the development time by eliminating the need to re-create the fundamental implementation of the Kalman filter for each new application. The GKF software is written in the ANSI C programming language. It contains a generic Kalman-filter-development directory that, in turn, contains a code for a generic Kalman filter function; more specifically, it contains a generically designed and generically coded implementation of linear, linearized, and extended Kalman filtering algorithms, including algorithms for state- and covariance-update and -propagation functions. The mathematical theory that underlies the algorithms is well known and has been reported extensively in the open technical literature. Also contained in the directory are a header file that defines generic Kalman-filter data structures and prototype functions and template versions of application-specific subfunction and calling navigation/estimation routine code and headers. Once the user has provided a calling routine and the required application-specific subfunctions, the application-specific Kalman-filter software can be compiled and executed immediately. During execution, the generic Kalman-filter function is called from a higher-level navigation or estimation routine that preprocesses measurement data and post-processes output data. The generic Kalman-filter function uses the aforementioned data structures and five implementation- specific subfunctions, which have been developed by the user on

A randomized crossover study comparing the antiplatelet effect of plavix versus generic clopidogrel.

PubMed

Sambu, Nalyaka; Radhakrishnan, Ashwin; Curzen, Nick

2012-12-01

Clopidogrel exists in different salt formulations. All published data that have demonstrated its beneficial effect are based entirely on the hydrogen sulphate salt contained in the branded product Plavix, which had US sales of $6.1 billion in 2010 alone. A number of cheaper generic versions of clopidogrel are increasingly being used in Europe as an alternative to Plavix, mainly for cost reasons. However, there is insufficient evidence to show that their pharmacodynamic effect is equivalent to Plavix. This prospective study investigated whether there is any significant difference in the antiplatelet effect of Plavix versus generic clopidogrel hydrochloride in healthy male volunteers. All participants received loading and maintenance doses of both drugs, in a crossover manner, separated by a 2-week washout period. Adenosine diphosphate (ADP)-induced platelet reactivity was measured using short thrombelastography at multiple timepoints. The results showed interindividual heterogeneity in responses to clopidogrel but no significant difference in ADP-induced platelet reactivity between Plavix versus generic clopidogrel hydrochloride. Our findings suggest comparable inhibition of ADP-induced platelet reactivity with Plavix and generic clopidogrel hydrochloride. This observation is particularly pertinent at a time when the patent for Plavix is expected to expire in the near future leading to the large-scale switch to cheaper generic preparations.

Determinants of generic drug substitution in Switzerland.

PubMed

Decollogny, Anne; Eggli, Yves; Halfon, Patricia; Lufkin, Thomas M

2011-01-26

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. 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.). 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%. 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 beliefs are probably the main determinant of generic

The HTA core model: a novel method for producing and reporting health technology assessments.

PubMed

Lampe, Kristian; Mäkelä, Marjukka; Garrido, Marcial Velasco; Anttila, Heidi; Autti-Rämö, Ilona; Hicks, Nicholas J; Hofmann, Björn; Koivisto, Juha; Kunz, Regina; Kärki, Pia; Malmivaara, Antti; Meiesaar, Kersti; Reiman-Möttönen, Päivi; Norderhaug, Inger; Pasternack, Iris; Ruano-Ravina, Alberto; Räsänen, Pirjo; Saalasti-Koskinen, Ulla; Saarni, Samuli I; Walin, Laura; Kristensen, Finn Børlum

2009-12-01

The aim of this study was to develop and test a generic framework to enable international collaboration for producing and sharing results of health technology assessments (HTAs). Ten international teams constructed the HTA Core Model, dividing information contained in a comprehensive HTA into standardized pieces, the assessment elements. Each element contains a generic issue that is translated into practical research questions while performing an assessment. Elements were described in detail in element cards. Two pilot assessments, designated as Core HTAs were also produced. The Model and Core HTAs were both validated. Guidance on the use of the HTA Core Model was compiled into a Handbook. The HTA Core Model considers health technologies through nine domains. Two applications of the Model were developed, one for medical and surgical interventions and another for diagnostic technologies. Two Core HTAs were produced in parallel with developing the model, providing the first real-life testing of the Model and input for further development. The results of formal validation and public feedback were primarily positive. Development needs were also identified and considered. An online Handbook is available. The HTA Core Model is a novel approach to HTA. It enables effective international production and sharing of HTA results in a structured format. The face validity of the Model was confirmed during the project, but further testing and refining are needed to ensure optimal usefulness and user-friendliness. Core HTAs are intended to serve as a basis for local HTA reports. Core HTAs do not contain recommendations on technology use.

76 FR 69294 - Proposed Generic Communication Draft Generic Letter on Seismic Risk Evaluations for Operating...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-08

.... Nuclear Regulatory Commission (NRC) published for public comment Draft Generic Letter 2011-XX: Seismic... comment Draft Generic Letter 2011-XX: Seismic Risk Evaluations for Operating Reactors to inform addressees...

The generic danger and the idiosyncratic support

NASA Astrophysics Data System (ADS)

Temme, Arnaud; Nijp, Jelmer; van der Meij, Marijn; Samia, Jalal; Masselink, Rens

2016-04-01

This contribution argues two main points. First, that generic landscapes used in some modelling studies sometimes have properties or cause simulation results that are unrealistic. Such initially flat or straight-sloped landscapes, sometimes with minor random perturbations, e.g. form the backdrop for ecological simulations of vegetation growth and competition that predict catastrophic shifts. Exploratory results for semi-arid systems suggest that the results based on these generic landscapes are end-members from a distribution of results, rather than an unbiased, typical outcome. Apparently, the desire to avoid idiosyncrasy has unintended consequences. Second, we argue and illustrate that in fact new insights often come from close inspection of idiosyncratic case studies. Our examples from landslide systems, connectivity and soil formation show how a central role for the case study - either in empirical work or to provide model targets - has advanced our understanding. Both points contribute to the conclusion that it is dangerous to forget about annoying, small-scale, idiosyncratic and, indeed, perhaps bad-ass case studies in Earth Sciences.

The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine use

PubMed Central

Hassali, Mohamed Azmi; Alrasheedy, Alian A.; McLachlan, Andrew; Nguyen, Tuan Anh; AL-Tamimi, Saleh Karamah; Ibrahim, Mohamed Izham Mohamed; Aljadhey, Hisham

2013-01-01

Generic medicines are clinically interchangeable with original brand medicines and have the same quality, efficacy and safety profiles. They are, nevertheless, much cheaper in price. Thus, while providing the same therapeutic outcomes, generic medicines lead to substantial savings for healthcare systems. Therefore, the quality use of generic medicines is promoted in many countries. In this paper, we reviewed the role of generic medicines in healthcare systems and the experiences of promoting the use of generic medicines in eight selected countries, namely the United States (US), the United Kingdom (UK), Sweden, Finland, Australia, Japan, Malaysia and Thailand. The review showed that there are different main policies adopted to promote generic medicines such as generic substitution in the US, generic prescribing in the UK and mandatory generic substitution in Sweden and Finland. To effectively and successfully implement the main policy, different complementary policies and initiatives were necessarily introduced. Barriers to generic medicine use varied between countries from negative perceptions about generic medicines to lack of a coherent generic medicine policy, while facilitators included availability of information about generic medicines to both healthcare professionals and patients, brand interchangeability guidelines, regulations that support generic substitution by pharmacists, and incentives to both healthcare professionals and patients. PMID:25561861

The Portuguese generic medicines market: a policy analysis

PubMed Central

Simoens, Steven

2008-01-01

Objectives: This study aims to conduct a descriptive analysis of the policy environment surrounding the generic medicines retail market in Portugal. The policy analysis focuses on supply-side measures (i.e. market access, pricing, reference-pricing and reimbursement of generic medicines) and demand-side measures (i.e. incentives for physicians to prescribe, for pharmacists to dispense and for patients to use generic medicines). Methods: The policy analysis was based on an international literature review. Also, a simulation exercise was carried out to compute potential savings from substituting generic for originator medicines in Portugal using IMS Health data. Results: Portugal has developed a successful generic medicines market by increasing reimbursement of generic medicines (until October 2005), by introducing a reference-pricing system, by encouraging physicians to prescribe by international non-proprietary name (INN), and by allowing generic substitution by pharmacists. However, the development of the generic medicines market has been hindered by the existence of copies, pricing regulation, certain features of the reference-pricing system, weak incentives for physicians to prescribe generic medicines and a financial disincentive for pharmacists to dispense generic medicines. Increased generic substitution would be expected to reduce public expenditure on originator medicines by 45%. Conclusions: The development of the Portuguese generic medicines market has mainly been fuelled by supply-side measures. To support the further expansion of the market, policy makers need to strengthen demand-side measures inciting physicians to prescribe, pharmacists to dispense and patients to use generic medicines. PMID:25152781

Generic penetration in the retail antidepressant market.

PubMed

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.

Generic Fortran Containers (GFC)

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

Liakh, Dmitry

2016-09-01

The Fortran language does not provide a standard library that implements generic containers, like linked lists, trees, dictionaries, etc. The GFC software provides an implementation of generic Fortran containers natively written in Fortran 2003/2008 language. The following containers are either already implemented or planned: Stack (done), Linked list (done), Tree (done), Dictionary (done), Queue (planned), Priority queue (planned).

Some Comments on Mapping from Disease-Specific to Generic Health-Related Quality-of-Life Scales

PubMed Central

Palta, Mari

2013-01-01

An article by Lu et al. in this issue of Value in Health addresses the mapping of treatment or group differences in disease-specific measures (DSMs) of health-related quality of life onto differences in generic health-related quality-of-life scores, with special emphasis on how the mapping is affected by the reliability of the DSM. In the proposed mapping, a factor analytic model defines a conversion factor between the scores as the ratio of factor loadings. Hence, the mapping applies to convert true underlying scales and has desirable properties facilitating the alignment of instruments and understanding their relationship in a coherent manner. It is important to note, however, that when DSM means or differences in mean DSMs are estimated, their mapping is still of a measurement error–prone predictor, and the correct conversion coefficient is the true mapping multiplied by the reliability of the DSM in the relevant sample. In addition, the proposed strategy for estimating the factor analytic mapping in practice requires assumptions that may not hold. We discuss these assumptions and how they may be the reason we obtain disparate estimates of the mapping factor in an application of the proposed methods to groups of patients. PMID:23337233

Genericness of inflation in isotropic loop quantum cosmology.

PubMed

Date, Ghanashyam; Hossain, Golam Mortuza

2005-01-14

Nonperturbative corrections from loop quantum cosmology (LQC) to the scalar matter sector are already known to imply inflation. We prove that the LQC modified scalar field generates exponential inflation in the small scale factor regime, for all positive definite potentials, independent of initial conditions and independent of ambiguity parameters. For positive semidefinite potentials it is always possible to choose, without fine-tuning, a value of one of the ambiguity parameters such that exponential inflation results, provided zeros of the potential are approached at most as a power law in the scale factor. In conjunction with the generic occurrence of bounce at small volumes, particle horizon is absent, thus eliminating the horizon problem of the standard big bang model.

Generic Penetration in the Retail Antidepressant Market

PubMed Central

Kalali, Amir H.

2010-01-01

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. PMID:20622940

Small-scale zooplankton aggregations at the front of a Kuroshio warm-core ring

NASA Astrophysics Data System (ADS)

Yamamoto, Tamiji; Nishizawa, Satoshi

1986-11-01

A Longhurst-Hardy Plankton Recorder was used to study the small-scale zooplankton distribution across the front of a Kuroshio warm-core ring in June 1979. Zooplankton were strongly aggregated in the frontal region; patches of zooplankton and phytoplankton were spatially separated. A major part of the zooplankton assemblage consisted of neritic forms such as cladocerans and indicator species of the cold Oyashio water. This implies that lateral entrainment of coastal waters, which is directly influenced by the Oyashio, was an important factor in the formation of the aggregations at the Kuroshio warm-core ring front. Variation in the distribution of abundance peaks of individual zooplankton species was also observed. Futhermore, zooplankton showed more intensive non-randomness (aggregation) than phytoplankton and non-motile euphausiid's eggs. Thus, biological processes, such as motility and prey-predator interaction, also appeared to be regulating the patchiness.

Accelerated gravity testing of aquitard core permeability and implications at formation and regional scale

NASA Astrophysics Data System (ADS)

Timms, W. A.; Crane, R.; Anderson, D. J.; Bouzalakos, S.; Whelan, M.; McGeeney, D.; Rahman, P. F.; Acworth, R. I.

2016-01-01

Evaluating the possibility of leakage through low-permeability geological strata is critically important for sustainable water supplies, the extraction of fuels from coal and other strata, and the confinement of waste within the earth. The current work demonstrates that relatively rapid and realistic vertical hydraulic conductivity (Kv) measurements of aquitard cores using accelerated gravity can constrain and compliment larger-scale assessments of hydraulic connectivity. Steady-state fluid velocity through a low-K porous sample is linearly related to accelerated gravity (g level) in a centrifuge permeameter (CP) unless consolidation or geochemical reactions occur. A CP module was custom designed to fit a standard 2 m diameter geotechnical centrifuge (550 g maximum) with a capacity for sample dimensions up to 100 mm diameter and 200 mm length, and a total stress of ˜ 2 MPa at the base of the core. Formation fluids were used as influent to limit any shrink-swell phenomena, which may alter the permeability. Kv results from CP testing of minimally disturbed cores from three sites within a clayey-silt formation varied from 10-10 to 10-7 m s-1 (number of samples, n = 18). Additional tests were focussed on the Cattle Lane (CL) site, where Kv within the 99 % confidence interval (n = 9) was 1.1 × 10-9 to 2.0 × 10-9 m s-1. These Kv results were very similar to an independent in situ Kv method based on pore pressure propagation though the sequence. However, there was less certainty at two other core sites due to limited and variable Kv data. Blind standard 1 g column tests underestimated Kv compared to CP and in situ Kv data, possibly due to deionised water interactions with clay, and were more time-consuming than CP tests. Our Kv results were compared with the set-up of a flow model for the region, and considered in the context of heterogeneity and preferential flow paths at site and

Generic OCs bioequivalent, but much maligned.

PubMed

1989-06-01

Although generic oral contraceptives (OCs) are bioequivalent to brand-name formulations, many family planning professionals do not prescribe the significantly lower-priced generics. The Planned Parenthood Federation of America, for example, has refused to approve generic OCs for use in the organization's clinics, presumably because of concerns about their equivalent efficacy and safety. However, much of this skepticism may be fueled by misleading marketing by brand-name OC manufacturers. Sales representatives have reportedly told clinicians that generic OCs can be as much as 20% different from brand-name formulations, despite evidence collected by the US Food and Drug Administration confirming that there is virtually no difference except in terms of inert ingredients. In the case of many formulations, the variability between the generic and brand-name products is no different than the variability found between different lots of the same brand-name drug. Another obstacle to wider use of generic OCs is that discounts for large volume purchases make brand-name OCs the best buy for family planning clinics. Clinicians also note that clients complain of minor side effects whenever OC brands are changed, even if the compounds are the same. As the price of medication continues to rise, the more widespread availability of generic OCs will be especially important for teenagers and other low-income clients.

Large-scale Instability during Gravitational Collapse with Neutrino Transport and a Core-Collapse Supernova

NASA Astrophysics Data System (ADS)

Aksenov, A. G.; Chechetkin, V. M.

2018-04-01

Most of the energy released in the gravitational collapse of the cores of massive stars is carried away by neutrinos. Neutrinos play a pivotal role in explaining core-collape supernovae. Currently, mathematical models of the gravitational collapse are based on multi-dimensional gas dynamics and thermonuclear reactions, while neutrino transport is considered in a simplified way. Multidimensional gas dynamics is used with neutrino transport in the flux-limited diffusion approximation to study the role of multi-dimensional effects. The possibility of large-scale convection is discussed, which is interesting both for explaining SN II and for setting up observations to register possible high-energy (≳10MeV) neutrinos from the supernova. A new multi-dimensional, multi-temperature gas dynamics method with neutrino transport is presented.

Select Generic Dry-Storage Pilot Plant Design for Safeguards and Security by Design (SSBD) per Used Fuel Campaign

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

Demuth, Scott Francis; Sprinkle, James K.

As preparation to the year-end deliverable (Provide SSBD Best Practices for Generic Dry-Storage Pilot Scale Plant) for the Work Package (FT-15LA040501–Safeguards and Security by Design for Extended Dry Storage), the initial step was to select a generic dry-storage pilot plant design for SSBD. To be consistent with other DOE-NE Fuel Cycle Research and Development (FCR&D) activities, the Used Fuel Campaign was engaged for the selection of a design for this deliverable. For the work Package FT-15LA040501–“Safeguards and Security by Design for Extended Dry Storage”, SSBD will be initiated for the Generic Dry-Storage Pilot Scale Plant described by the layout ofmore » Reference 2. SSBD will consider aspects of the design that are impacted by domestic material control and accounting (MC&A), domestic security, and international safeguards.« less

Might generic OCs create contraceptive price war?

PubMed

1987-02-01

Genora 1/35 and 1/50, the 1st generic oral contraceptives (OCs) in the world, are now being marketed in the US. Clinicians interviewed by "Contraceptive Technology Update" (CTU) offer differing opinions as to what this new OC may mean in the marketplace. Products of Rugby Laboratories, the pills are copy products of Ortho Pharmaceutical's ON 1/35 and ON 1/50 formulations. Most clinicians believe that Genora's success or failure in the OC market depends on its eventual retail price. The price difference of $3-$4 may be sufficiently substantial for retailers to charge less for the generic OCs. If that is the case, many doctors may prescribe a pill which will save their patients $4/month. Dr. Mildred Hanson, a Minneapolis gynecologist/obstetrician, feels any cost savings from Genora will have a significant impact on the OC market. She suggests that the less expensive OCs will catch the attention of health maintenance organizations (HMOs) and the business of women who participate in such health plans. Yet James Burns, director of family planning services for the Hartford City Health Department, thinks that even a full-scale retail price war won't have much effect from a clinic standpoint. He reports that clinics are able to obtain contraceptive supplies rather inexpensively through the contracting system. Hanson also expressed doubt over the potential popularity of Genora 1/50 as clinical concerns about the effects of combined OCs on serum lipid levels and carbohydrate metabolism have resulted in a nationwide push toward OCs containing less than 50 micrograms of estrogen. He indicated concern that declines in pharmaceutical house products from pricing competition with generic pills might have a negative impact on contraceptive research and development. Dick Haskitt, director of business planning for Syntex Laboratories, Inc., who will produce the OCs for Rugby, reports that their market research shows that people are very interested in having a generic OC available

An integrated, cross-disciplinary study of soil hydrophobicity at atomic, molecular, core and landscape scales

NASA Astrophysics Data System (ADS)

Matthews, G. Peter; Doerr, Stefan; Van Keulen, Geertje; Dudley, Ed; Francis, Lewis; Whalley, Richard; Gazze, Andrea; Hallin, Ingrid; Quinn, Gerry; Sinclair, Kat; Ashton, Rhys

2017-04-01

Soil hydrophobicity can lead to reduced soil fertility and heightened flood risk caused by increased run-off. Soil hydrophobicity is a well-known phenomenon when induced by natural events such as wildfires and anthropogenic causes including adding organic wastes or hydrocarbon contaminants. This presentation concerns a much more subtle effect - the naturally occurring changes between hydrophilic and hydrophobic states caused by periods of wetness and drought. Although subtle, they nevertheless affect vast areas of soil, and so their effects can be very significant, and are predicted to increase under climate change conditions. To understand the effect, a major interdisciplinary study has been commissioned by the UK's Natural Environment Research Council (NERC) to investigate soil hydrophobicity over length scales ranging from atomic through molecular, core and landscape scale. We present the key findings from the many publications currently in preparation. The programme is predicated on the hypothesis that changes in soil protein abundance and localization, induced by variations in soil moisture and temperature, are crucial driving forces for transitions between hydrophobic and hydrophilic conditions at soil particle surfaces, and that these effects can be meaningfully upscaled from molecular to landscape scale. Three soils were chosen based on the severity of hydrophobicity that can be achieved in the field: severe to extreme (natural rough pasture, Wales), intermediate to severe (pasture, Wales), and subcritical (managed research grassland, Rothamsted Research, England). The latter is already highly characterised so was also used as a control. Hydrophobic/ hydrophilic transitions were determined from water droplet penetration times. Scientific advances in the following five areas will be described: (i) the identification of these soil proteins by proteomic methods, using novel separation methods which reduces interference by humic acids, and allows identification

Generic medicines: solutions for a sustainable drug market?

PubMed

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

2013-10-01

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

TRAC-BF1 thermal-hydraulic, ANSYS stress analysis for core shroud cracking phenomena

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

Shoop, U.; Feltus, M.A.; Baratta, A.J.

1996-12-31

The U.S. Nuclear Regulatory Commission sent Generic Letter 94-03 informing all licensees about the intergranular stress corrosion cracking (IGSCC) of core shrouds found in both Dresden unit I and Quad Cities unit 1. The letter directed all licensees to perform safety analysis of their boiling water reactor (BWR) units. Two transients of special concern for the core shroud safety analysis include the main steam line break (MSLB) and recirculation line break transient.

40 CFR 721.1655 - Alkylbenzenesulfonic acid (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Alkylbenzenesulfonic acid (generic... Substances § 721.1655 Alkylbenzenesulfonic acid (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylbenzenesulfonic acid (PMN...

40 CFR 721.9685 - Mixed trialkylamines (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Mixed trialkylamines (generic). 721... Substances § 721.9685 Mixed trialkylamines (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as mixed trialkylamines (PMNs P-97...

40 CFR 721.9685 - Mixed trialkylamines (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Mixed trialkylamines (generic). 721... Substances § 721.9685 Mixed trialkylamines (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as mixed trialkylamines (PMNs P-97...

40 CFR 721.9685 - Mixed trialkylamines (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Mixed trialkylamines (generic). 721... Substances § 721.9685 Mixed trialkylamines (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as mixed trialkylamines (PMNs P-97...

40 CFR 721.9685 - Mixed trialkylamines (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Mixed trialkylamines (generic). 721... Substances § 721.9685 Mixed trialkylamines (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as mixed trialkylamines (PMNs P-97...

40 CFR 721.9685 - Mixed trialkylamines (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Mixed trialkylamines (generic). 721... Substances § 721.9685 Mixed trialkylamines (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as mixed trialkylamines (PMNs P-97...

40 CFR 721.10172 - Alkylamide derivative (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Alkylamide derivative (generic). 721... Substances § 721.10172 Alkylamide derivative (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylamide derivative (PMN P-03...

40 CFR 721.10172 - Alkylamide derivative (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkylamide derivative (generic). 721... Substances § 721.10172 Alkylamide derivative (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylamide derivative (PMN P-03...

40 CFR 721.9973 - Zirconium dichlorides (generic).

Code of Federal Regulations, 2010 CFR

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...

40 CFR 721.10035 - Alkylbenzene sulfonate (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkylbenzene sulfonate (generic). 721... Substances § 721.10035 Alkylbenzene sulfonate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylbenzene sulfonate (PMN-02...

40 CFR 721.10035 - Alkylbenzene sulfonate (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Alkylbenzene sulfonate (generic). 721... Substances § 721.10035 Alkylbenzene sulfonate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylbenzene sulfonate (PMN-02...

40 CFR 721.9959 - Polyurethane polymer (generic).

Code of Federal Regulations, 2010 CFR

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...

40 CFR 721.9959 - Polyurethane polymer (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 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...

40 CFR 721.10501 - Tridecyl phthalate (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Tridecyl phthalate (generic). 721... Substances § 721.10501 Tridecyl phthalate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tridecyl phthalate (PMN P-06-542...

40 CFR 721.9959 - Polyurethane polymer (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 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...

40 CFR 721.9959 - Polyurethane polymer (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 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...

40 CFR 721.9959 - Polyurethane polymer (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 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...

Is bioavailability altered in generic versus brand anticonvulsants?

PubMed

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.

Generic health/safety/environment cases

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

Kelland, A.N.; Primrose, M.; Pickles, J.C.

1996-12-31

A desire to implement HSE Management Systems including HSE Cases in all Shell companies operations prompted the development of a relational data base software package (THESIS) to provide a structured way of preparing an HSE Case. The software includes features which facilitate the management of {open_quotes}Keeping the Case Alive{close_quotes}, enabling the dissemination of tasks and hazard information to the workplace. During the software development it was recognized that a significant reduction could be made in the resources which would be required to prepare an HSE Case for each and every operation by the building of {open_quotes}Generic HSE Cases{close_quotes} addressing specificmore » activities which were repeated across the Company`s operations. This was recognized to be particularly valid for the smaller Single String Venture type of operations. The activities selected for the initial Generic HSE Case development include Land Drilling Operations, Land Seismic Acquisition, and Land Transport. To establish the Generic HSE Case, the THESIS data base is populated with data for a generic operation, identifying all the hazards and activities associated with that operation including all the associated controls, with established formats for the textual sections. In effect, the Generic Case defines the standards required for that type of operation. To generate an operation specific HSE Case, the Generic Case thereafter requires to be modified/adapted so that it represents the actual situation in the operation which it defines. This process includes itemization of all the operation specific details, and may involve the inclusion/deletion of any additional/existing activities or hazards together with their associated controls.« less

A multicenter experience with generic tacrolimus conversion.

PubMed

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.

PubMed

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.

Some comments on mapping from disease-specific to generic health-related quality-of-life scales.

PubMed

Palta, Mari

2013-01-01

An article by Lu et al. in this issue of Value in Health addresses the mapping of treatment or group differences in disease-specific measures (DSMs) of health-related quality of life onto differences in generic health-related quality-of-life scores, with special emphasis on how the mapping is affected by the reliability of the DSM. In the proposed mapping, a factor analytic model defines a conversion factor between the scores as the ratio of factor loadings. Hence, the mapping applies to convert true underlying scales and has desirable properties facilitating the alignment of instruments and understanding their relationship in a coherent manner. It is important to note, however, that when DSM means or differences in mean DSMs are estimated, their mapping is still of a measurement error-prone predictor, and the correct conversion coefficient is the true mapping multiplied by the reliability of the DSM in the relevant sample. In addition, the proposed strategy for estimating the factor analytic mapping in practice requires assumptions that may not hold. We discuss these assumptions and how they may be the reason we obtain disparate estimates of the mapping factor in an application of the proposed methods to groups of patients. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Influencers of generic drug utilization: A systematic review.

PubMed

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.

40 CFR 721.10113 - Thioether epoxy (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Thioether epoxy (generic). 721.10113... Substances § 721.10113 Thioether epoxy (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as thioether epoxy (PMN P-04-547) is subject to...

40 CFR 721.10113 - Thioether epoxy (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Thioether epoxy (generic). 721.10113... Substances § 721.10113 Thioether epoxy (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as thioether epoxy (PMN P-04-547) is subject to...

40 CFR 721.10113 - Thioether epoxy (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Thioether epoxy (generic). 721.10113... Substances § 721.10113 Thioether epoxy (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as thioether epoxy (PMN P-04-547) is subject to...

40 CFR 721.10113 - Thioether epoxy (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Thioether epoxy (generic). 721.10113... Substances § 721.10113 Thioether epoxy (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as thioether epoxy (PMN P-04-547) is subject to...

40 CFR 721.10113 - Thioether epoxy (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Thioether epoxy (generic). 721.10113... Substances § 721.10113 Thioether epoxy (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as thioether epoxy (PMN P-04-547) is subject to...

40 CFR 721.10318 - Mannich bases (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Mannich bases (generic). 721.10318... Substances § 721.10318 Mannich bases (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as mannich bases (PMNs P-02-1078 and P-02-1080...

40 CFR 721.10318 - Mannich bases (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Mannich bases (generic). 721.10318... Substances § 721.10318 Mannich bases (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as mannich bases (PMNs P-02-1078 and P-02-1080...

Generic Competency Frameworks: A Brief Historical Overview

ERIC Educational Resources Information Center

Young, Jolee; Chapman, Elaine

2010-01-01

Significant efforts have now been made to identify the generic competencies required to succeed across different workplace contexts. The aims of this paper were to: (i) outline factors that contributed to the increased demand for generic competencies seen over the last three decades; and (ii) review the early generic competency frameworks…

Generic domain models in software engineering

NASA Technical Reports Server (NTRS)

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.

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

PubMed Central

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

2015-01-01

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

Generic radiation quarantine treatments: the next steps.

PubMed

Follett, Peter A

2009-08-01

In 2006, U.S. Department of Agriculture-Animal and Plant Health Inspection Service published a landmark rule providing generic radiation quarantine treatments. The rule approved radiation doses of 150 Gy for any tephritid fruit fly and 400 Gy for all other insects except the pupa and adult stages of Lepidoptera. The generic radiation treatments apply to all fresh horticultural commodities. Therefore, if a pest risk assessment demonstrates that no pupae or adult Lepidoptera are associated with a commodity, export approval can be forthcoming with no further research. Generic treatments are the culmination of decades of research but not an end point. Future research on quarantine and phytosanitary uses of radiation should focus on 1) development of specific doses for quarantine Lepidoptera not covered by the generic treatments, 2) reduction of dose levels for specific pests and commodities to shorten treatment time and minimize any deleterious effects of radiation treatment on commodity quality, 3) development of generic doses below 400 Gy for important groups of quarantine arthropods other than fruit flies, and 4) development of information on commodity tolerance and development of value-added irradiated fresh products that use generic radiation treatments. Generic treatments will facilitate safe trade between countries that have approved phytosanitary uses of radiation for fresh agricultural commodities.

Individual differences in children's and parents' generic language

PubMed Central

Gelman, Susan A.; Ware, Elizabeth A.; Kleinberg, Felicia; Manczak, Erika M.; Stilwell, Sarah M.

2014-01-01

Generics (“Dogs bark”) convey important information about categories and facilitate children’s learning. Two studies with parents and their 2- or 4-year-old children (N=104 dyads) examined whether individual differences in generic language use are: (a) stable over time, contexts, and domains, and (b) linked to conceptual factors. For both children and parents, individual differences in rate of generic production were stable across time, contexts, and domains, and parents' generic usage significantly correlated with that of their own children. Furthermore, parents’ essentialist beliefs correlated with their own and their children’s rates of generic frequency. These results indicate that generic language use exhibits substantial stability and may reflect individual differences in speakers’ conceptual attitudes toward categories. PMID:24266531

ELT-scale Adaptive Optics real-time control with thes Intel Xeon Phi Many Integrated Core Architecture

NASA Astrophysics Data System (ADS)

Jenkins, David R.; Basden, Alastair; Myers, Richard M.

2018-05-01

We propose a solution to the increased computational demands of Extremely Large Telescope (ELT) scale adaptive optics (AO) real-time control with the Intel Xeon Phi Knights Landing (KNL) Many Integrated Core (MIC) Architecture. The computational demands of an AO real-time controller (RTC) scale with the fourth power of telescope diameter and so the next generation ELTs require orders of magnitude more processing power for the RTC pipeline than existing systems. The Xeon Phi contains a large number (≥64) of low power x86 CPU cores and high bandwidth memory integrated into a single socketed server CPU package. The increased parallelism and memory bandwidth are crucial to providing the performance for reconstructing wavefronts with the required precision for ELT scale AO. Here, we demonstrate that the Xeon Phi KNL is capable of performing ELT scale single conjugate AO real-time control computation at over 1.0kHz with less than 20μs RMS jitter. We have also shown that with a wavefront sensor camera attached the KNL can process the real-time control loop at up to 966Hz, the maximum frame-rate of the camera, with jitter remaining below 20μs RMS. Future studies will involve exploring the use of a cluster of Xeon Phis for the real-time control of the MCAO and MOAO regimes of AO. We find that the Xeon Phi is highly suitable for ELT AO real time control.

A Generic Expert Scheduling System Architecture and Toolkit: GUESS (Generically Used Expert Scheduling System)

NASA Technical Reports Server (NTRS)

Liebowitz, Jay; Krishnamurthy, Vijaya; Rodens, Ira; Houston, Chapman; Liebowitz, Alisa; Baek, Seung; Radko, Joe; Zeide, Janet

1996-01-01

Scheduling has become an increasingly important element in today's society and workplace. Within the NASA environment, scheduling is one of the most frequently performed and challenging functions. Towards meeting NASA's scheduling needs, a research version of a generic expert scheduling system architecture and toolkit has been developed. This final report describes the development and testing of GUESS (Generically Used Expert Scheduling System).

Generic Skills for Occupational Training.

ERIC Educational Resources Information Center

Smith, Arthur De W.

Generic skills are those overt and covert behaviors which are fundamental to the performance of many tasks and subtasks carried out in a wide range of occupations and which are basic to both specialized applications and job specific skills. They consist of academic, reasoning, interpersonal and manipulation skills. The generic approach is…

Generic analysis of kinetically driven inflation

NASA Astrophysics Data System (ADS)

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.

Generics market in Greece: the pharmaceutical industry's beliefs.

PubMed

Geitona, Mary; Zavras, Dimitrios; Hatzikou, Magda; Kyriopoulos, John

2006-11-01

The aim of this study was to investigate the beliefs and perspectives of the pharmaceutical industry on generic medication in Greece. Questionnaires were mailed to all 58 members of the Hellenic Association of Pharmaceutical Companies from November 2002 to February 2003. The response rate was 52%, namely 30 questionnaires were completed and returned. The questionnaire requested information on companies' involvement in generics, their opinion on generics' characteristics and on public policies affecting the demand and supply of generic medication. A descriptive analysis of the outcomes, that is percentage comparison through binomial tests and Fisher tests, was performed. According to our findings, 43% of the respondents were involved in the production and distribution of generics and the mean period of their involvement was 12 years. The majority of the respondents were in favor of their companies' involvement in generics, despite the relatively small market share of generics in Greece; 9.7% of total pharmaceutical market in 2003. Bearing in mind that in Greece the promotion of generics is not encouraged, pharmaceutical companies believe that the mandatory introduction of bioequivalence studies is an indirect promotional strategy towards generics. Additionally, the majority declared that their main competitive advantages are their safety, efficacy and effectiveness as well as their economic benefit to the society. Finally, the respondents expressed their preference for the introduction of pharmacoeconomic submissions for drugs' reimbursement by social insurance funds.

Generic medicines: Greek physicians' perceptions and prescribing practices.

PubMed

Tsiantou, V; Zavras, D; Kousoulakou, H; Geitona, M; Kyriopoulos, J

2009-10-01

The penetration of generic drugs in the Greek pharmaceutical market is placed among the weakest in the EU. The Greek regulatory framework does not systematically support the development of this subsector and physicians are not provided with incentives for prescribing generics. The aim of this study was to investigate the prescribing profile of physicians in Greece with a focus on the factors that influence their decision on generics prescribing. A structured questionnaire was sent by mail to a random national sample of 1463 physicians, stratified by sex, specialty and geographical region. The response rate was 82.3%. Greek physicians have a positive view on generics but they prefer to prescribe the original products. According to our analysis, physician's age and their opinion on generics' efficacy and effectiveness are identified as important determinants of their prescribing decision. The primary reason that could make them change their prescribing habits is the appearance of side-effects. Patients' insurance coverage and income, as well as the drug cost are also referred as factors that influence their prescribing decision. Despite the fact that they do not usually prescribe generics in their clinical practice, they are willing to substitute an original drug by a generic product. Our findings suggest that Greek physicians could be persuaded to prescribe generic medicines, if a generic promotion policy was introduced in the country. To develop such a policy, a set of supply side and demand-side measures should be implemented along with provision of information on generics to physicians during their education and clinical practice.

What Is the Future of Generics in Transplantation?

PubMed

van Gelder, Teun

2015-11-01

Generic immunosuppressive drugs are available in Europe, Canada, and the United States. Between countries, there are large differences in the market penetration of generic drugs in general, and for immunosuppressive drugs in particular. The registration criteria for generic immunosuppressive drugs are often criticized. However, it is unlikely that the criteria for registration of narrow therapeutic index drugs are going to change, and bioequivalence studies, performed in healthy volunteers, will remain the backbone of the registration process. It would be good if the registration authorities would demand that all generic variants of an innovator drug have the same pill appearance to reduce errors and promote drug adherence.To allow for safe substitution, a number of criteria need to be fulfilled. Generic substitution should not be taken out of the hands of the treating physicians. Generic substitution can only be done safely if initiated by the prescriber, and in well-informed and prepared patients. Payers should refrain from forcing pharmacists to dispense generic drugs in patients on maintenance treatment with innovator drug. Instead, together with transplant societies, they should design guidelines on how to implement generic immunosuppressive drugs into clinical practice. Substitutions must be followed by control visits to check if the patient is taking the medication correctly and if drug exposure remains stable. Inadvertent, uncontrolled substitutions from 1 generic to another, initiated outside the scope of the prescriber, must be avoided as they are unsafe. Repetitive subsequent generic substitutions result in minimal additional cost savings and have an inherent risk of medication errors.

[Vertical integration and contracting-out in generic hospital services in Spain].

PubMed

Puig-Junoy, J; Pérez-Sust, P

2002-01-01

This study examines the factors that influence make or buy decisions corresponding to four generic services (housekeeping, laundry, food services, and maintenance and security) in Spanish hospitals (3,160 transactions in 790 hospitals). The empirical estimation of a logistic model based on hospital utility maximization is presented. Factors included in the model are not only those related to transaction costs, but also those related to public intervention and the political dimension. A total of 55.7% of hospitals contracted-out at least one of the generic services. The services most frequently contracted-out were housekeeping and maintenance and security(45.1 and 32.5%, respectively). In contrast, the services (94.3% and 80.1%, respectively). Hospital size (economies of scale), measured by the number of beds, was one of the most important factors influencing make or buy decisions. We find evidence that economies of scale are related to a higher level of vertical integration, while specialization and for-profit objectives favor the decision to contract-out. The choice of organizational model for laundry services presents a different pattern from that of the other three services. Empirical results show that some asset specificity could be present in laundry services.

The PedsQL™ Oral Health Scale: feasibility, reliability and validity of the Brazilian Portuguese version

PubMed Central

2012-01-01

Background Oral and orofacial problems may cause a profound impact on children’s oral health-related quality of life (OHRQoL) because of symptoms associated with these conditions that may influence the physical, psychological and social aspects of their daily life. The OHRQoL questionnaires found in the literature are very specific and are not able to measure the impact of oral health on general health domains. Consequently, the objective of this study was to evaluate the psychometric properties of the Portuguese version for Brazilian translation of the Pediatric Quality of Life Inventory™ (PedsQL™) Oral Health Scale in combination with the PedsQL™ 4.0 Generic Core Scales. Methods The PedsQL™ Oral Health Scale was forward-backward translated and cross-culturally adapted for the Brazilian Portuguese language. In order to assess the feasibility, reliability and validity of the Brazilian version of the instrument, a study was carried out in Belo Horizonte with 208 children and adolescents between 2 and 18 years-of-age and their parents. Clinical evaluation of dental caries, socioeconomic information and the Brazilian versions of the PedsQL™ Oral Health Scale, PedsQL™ 4.0 Generic Core Scales, Child Perceptions Questionnaire (CPQ11-14 and CPQ8-10) and Parental-Caregiver Perception Questionnaire (P-CPQ) were administered. Statistical analysis included feasibility (missing values), confirmatory factor analysis (CFA), internal consistency reliability, and test-retest intraclass correlation coefficients (ICC) of the PedsQL™ Oral Health Scale. Results There were no missing data for both child self-report and parent proxy-report on the Brazilian version of the PedsQL™ Oral Health Scale. The CFA showed that the five items of child self-report and parent proxy-report loaded on a single construct. The Cronbach's alpha coefficients for child/adolescent and parent oral health instruments were 0.65 and 0.59, respectively. The test-retest reliability (ICC) for

Large-scale shell-model calculation with core excitations for neutron-rich nuclei beyond 132Sn

NASA Astrophysics Data System (ADS)

Jin, Hua; Hasegawa, Munetake; Tazaki, Shigeru; Kaneko, Kazunari; Sun, Yang

2011-10-01

The structure of neutron-rich nuclei with a few nucleons beyond 132Sn is investigated by means of large-scale shell-model calculations. For a considerably large model space, including neutron core excitations, a new effective interaction is determined by employing the extended pairing-plus-quadrupole model with monopole corrections. The model provides a systematical description for energy levels of A=133-135 nuclei up to high spins and reproduces available data of electromagnetic transitions. The structure of these nuclei is analyzed in detail, with emphasis of effects associated with core excitations. The results show evidence of hexadecupole correlation in addition to octupole correlation in this mass region. The suggested feature of magnetic rotation in 135Te occurs in the present shell-model calculation.

Floquet–Magnus theory and generic transient dynamics in periodically driven many-body quantum systems

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

Kuwahara, Tomotaka, E-mail: tomotaka.phys@gmail.com; WPI, Advanced Institute for Materials Research, Tohoku University, Sendai 980-8577; Mori, Takashi

2016-04-15

This work explores a fundamental dynamical structure for a wide range of many-body quantum systems under periodic driving. Generically, in the thermodynamic limit, such systems are known to heat up to infinite temperature states in the long-time limit irrespective of dynamical details, which kills all the specific properties of the system. In the present study, instead of considering infinitely long-time scale, we aim to provide a general framework to understand the long but finite time behavior, namely the transient dynamics. In our analysis, we focus on the Floquet–Magnus (FM) expansion that gives a formal expression of the effective Hamiltonian onmore » the system. Although in general the full series expansion is not convergent in the thermodynamics limit, we give a clear relationship between the FM expansion and the transient dynamics. More precisely, we rigorously show that a truncated version of the FM expansion accurately describes the exact dynamics for a certain time-scale. Our theory reveals an experimental time-scale for which non-trivial dynamical phenomena can be reliably observed. We discuss several dynamical phenomena, such as the effect of small integrability breaking, efficient numerical simulation of periodically driven systems, dynamical localization and thermalization. Especially on thermalization, we discuss a generic scenario on the prethermalization phenomenon in periodically driven systems. -- Highlights: •A general framework to describe transient dynamics for periodically driven systems. •The theory is applicable to generic quantum many-body systems including long-range interacting systems. •Physical meaning of the truncation of the Floquet–Magnus expansion is rigorously established. •New mechanism of the prethermalization is proposed. •Revealing an experimental time-scale for which non-trivial dynamical phenomena can be reliably observed.« less

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

PubMed Central

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

A generic, cost-effective, and scalable cell lineage analysis platform

PubMed Central

Biezuner, Tamir; Spiro, Adam; Raz, Ofir; Amir, Shiran; Milo, Lilach; Adar, Rivka; Chapal-Ilani, Noa; Berman, Veronika; Fried, Yael; Ainbinder, Elena; Cohen, Galit; Barr, Haim M.; Halaban, Ruth; Shapiro, Ehud

2016-01-01

Advances in single-cell genomics enable commensurate improvements in methods for uncovering lineage relations among individual cells. Current sequencing-based methods for cell lineage analysis depend on low-resolution bulk analysis or rely on extensive single-cell sequencing, which is not scalable and could be biased by functional dependencies. Here we show an integrated biochemical-computational platform for generic single-cell lineage analysis that is retrospective, cost-effective, and scalable. It consists of a biochemical-computational pipeline that inputs individual cells, produces targeted single-cell sequencing data, and uses it to generate a lineage tree of the input cells. We validated the platform by applying it to cells sampled from an ex vivo grown tree and analyzed its feasibility landscape by computer simulations. We conclude that the platform may serve as a generic tool for lineage analysis and thus pave the way toward large-scale human cell lineage discovery. PMID:27558250

Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C.

PubMed

Hill, Andrew; Simmons, Bryony; Gotham, Dzintars; Fortunak, Joseph

2016-01-01

Novel treatments for hepatitis C demonstrate high cure rates, but current high prices can be a barrier to rapid global treatment scale-up. Generic competition can rapidly lower drug prices. Using data on exports of raw materials in 2015, we calculated currently feasible generic prices of sofosbuvir and daclatasvir. Data on per-kilogram prices of sofosbuvir and daclatasvir active pharmaceutical ingredients (API) exported from India were extracted from an online database. To the cost of the amount of API needed for a 12-week treatment course, we added cost estimates for formulation (40%), packaging (US$0.35/month), and a mark-up (50%). Between 1 January and 15 October 2015, over 5 tons of sofosbuvir were exported, with prices decreasing by US$702/kg/month, and observed prices of US$2501/kg in early September. Over the same period, 84 kg of daclatasvir were exported, with prices decreasing by US$1664/kg/month to US$1897/kg. Using the price estimation algorithm, we estimated the price of a generic sofosbuvir-daclatasvir combination regimen at US$200 per patient for a 12-week treatment course. The costs of generic production of sofosbuvir and daclatasvir are rapidly decreasing. Sofosbuvir-daclatasvir combination treatment could be produced for US$200 per patient per 12-week course.

Retailing policies for generic medicines.

PubMed

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.

Operationally Efficient Propulsion System Study (OEPSS) data book. Volume 1: Generic ground operations data

NASA Technical Reports Server (NTRS)

Byrd, Raymond J.

1990-01-01

This study was initiated to identify operations problems and cost drivers for current propulsion systems and to identify technology and design approaches to increase the operational efficiency and reduce operations costs for future propulsion systems. To provide readily usable data for the Advance Launch System (ALS) program, the results of the Operationally Efficient Propulsion System Study (OEPSS) were organized into a series of OEPSS Data Books as follows: Volume 1, Generic Ground Operations Data; Volume 2, Ground Operations Problems; Volume 3, Operations Technology; Volume 4, OEPSS Design Concepts; and Volume 5, OEPSS Final Review Briefing, which summarizes the activities and results of the study. This volume presents ground processing data for a generic LOX/LH2 booster and core propulsion system based on current STS experience. The data presented includes: top logic diagram, process flow, activities bar-chart, loaded timelines, manpower requirements in terms of duration, headcount and skill mix per operations and maintenance instruction (OMI), and critical path tasks and durations.

Core and peripheral criteria of video game addiction in the game addiction scale for adolescents.

PubMed

Brunborg, Geir Scott; Hanss, Daniel; Mentzoni, Rune Aune; Pallesen, Ståle

2015-05-01

Assessment of video game addiction often involves measurement of peripheral criteria that indicate high engagement with games, and core criteria that indicate problematic use of games. A survey of the Norwegian population aged 16-74 years (N=10,081, response rate 43.6%) was carried out in 2013, which included the Gaming Addiction Scale for Adolescents (GAS). Confirmatory factor analysis showed that a two-factor structure, which separated peripheral criteria from core criteria, fitted the data better (CFI=0.963; RMSEA=0.058) compared to the original one-factor solution where all items are determined to load only on one factor (CFI=0.905, RMSEA=0.089). This was also found when we analyzed men aged ≤33 years, men aged >33 years, women aged ≤33 years, and women aged >33 years separately. This indicates that the GAS measures both engagement and problems related to video games. Multi-group measurement invariance testing showed that the factor structure was valid in all four groups (configural invariance) for the two-factor structure but not for the one-factor structure. A novel approach to categorization of problem gamers and addicted gamers where only the core criteria items are used (the CORE 4 approach) was compared to the approach where all items are included (the GAS 7 approach). The current results suggest that the CORE 4 approach might be more appropriate for classification of problem gamers and addicted gamers compared to the GAS 7 approach.

Generic penetration in the retail atypical antipsychotic market.

PubMed

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.

Generic Penetration in the Retail Atypical Antipsychotic Market

PubMed Central

Kalali, Amir H; Buckley, Peter

2010-01-01

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. PMID:20436769

Generic oncology drugs: are they all safe?

PubMed

Yang, Y Tony; Nagai, Sumimasa; Chen, Brian K; Qureshi, Zaina P; Lebby, Akida A; Kessler, Samuel; Georgantopoulos, Peter; Raisch, Dennis W; Sartor, Oliver; Hermanson, Terhi; Kane, Robert C; Hrushesky, William J; Riente, Joshua J; Norris, LeAnn B; Bobolts, Laura R; Armitage, James O; Bennett, Charles L

2016-11-01

Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel). We also review regulatory reports from Japan and the USA, countries with the largest pharmaceutical expenditures. Empirical studies did not identify safety concerns in the USA, Canada, the EU, and Japan, where regulations and enforcement are strong. Although manufacturing problems for generic pharmaceuticals exist in India, where 40% of all generic pharmaceuticals used in the USA are manufactured, increased inspections and communication by the US Food and Drug Administration are occurring, facilitating oversight and enforcement. No safety outbreaks among generic oncology drugs were reported in developed countries. For developing countries, oversight is less intensive, and concerns around drug safety still exist. Regulatory agencies should collaboratively develop procedures to monitor the production, shipment, storage, and post-marketing safety of generic oncology drugs. Regulatory agencies for each country should also aim towards identical definitions of bioequivalence, the cornerstone of regulatory approval. Copyright © 2016 Elsevier Ltd. All rights reserved.

A theoretical investigation of soliton induced supercontinuum generation in liquid core photonic crystal fiber and dual core optical fiber

NASA Astrophysics Data System (ADS)

Porsezian, K.; Nithyanandan, K.; Vasantha Jayakantha Raja, R.; Ganapathy, R.

2013-07-01

The supercontinuum generation (SCG) in liquid core photonic crystal fiber (LCPCF) with versatile nonlinear response and the spectral broadening in dual core optical fiber is presented. The analysis is presented in two phase, phase I deals with the SCG in LCPCF with the effect of saturable nonlinearity and re-orientational nonlinearity. We identify and discuss the generic nature of the saturable nonlinearity and reorientational nonlinearity in the SCG, using suitable model. For the physical explanation, modulational instability and soliton fission techniques is implemented to investigate the impact of saturable nonlinear response and slow nonlinear response, respectively. It is observed that the saturable nonlinearity inevitably suppresses the MI and the subsequent SCG. On the other hand, the re-orientational nonlinearity contributes to the slow nonlinear response in addition to the conventional fast response due to the electronic contribution. The phase II features the exclusive investigation of the spectral broadening in the dual core optical fiber.

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

PubMed

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

2015-09-01

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

Deriving micro- to macro-scale seismic velocities from ice-core c axis orientations

NASA Astrophysics Data System (ADS)

Kerch, Johanna; Diez, Anja; Weikusat, Ilka; Eisen, Olaf

2018-05-01

One of the great challenges in glaciology is the ability to estimate the bulk ice anisotropy in ice sheets and glaciers, which is needed to improve our understanding of ice-sheet dynamics. We investigate the effect of crystal anisotropy on seismic velocities in glacier ice and revisit the framework which is based on fabric eigenvalues to derive approximate seismic velocities by exploiting the assumed symmetry. In contrast to previous studies, we calculate the seismic velocities using the exact c axis angles describing the orientations of the crystal ensemble in an ice-core sample. We apply this approach to fabric data sets from an alpine and a polar ice core. Our results provide a quantitative evaluation of the earlier approximative eigenvalue framework. For near-vertical incidence our results differ by up to 135 m s-1 for P-wave and 200 m s-1 for S-wave velocity compared to the earlier framework (estimated 1 % difference in average P-wave velocity at the bedrock for the short alpine ice core). We quantify the influence of shear-wave splitting at the bedrock as 45 m s-1 for the alpine ice core and 59 m s-1 for the polar ice core. At non-vertical incidence we obtain differences of up to 185 m s-1 for P-wave and 280 m s-1 for S-wave velocities. Additionally, our findings highlight the variation in seismic velocity at non-vertical incidence as a function of the horizontal azimuth of the seismic plane, which can be significant for non-symmetric orientation distributions and results in a strong azimuth-dependent shear-wave splitting of max. 281 m s-1 at some depths. For a given incidence angle and depth we estimated changes in phase velocity of almost 200 m s-1 for P wave and more than 200 m s-1 for S wave and shear-wave splitting under a rotating seismic plane. We assess for the first time the change in seismic anisotropy that can be expected on a short spatial (vertical) scale in a glacier due to strong variability in crystal-orientation fabric (±50 m s-1 per 10 cm

The Generic Resolution Advisor and Conflict Evaluator (GRACE) for Detect-And-Avoid (DAA) Systems

NASA Technical Reports Server (NTRS)

Abramson, Michael; Refai, Mohamad; Santiago, Confesor

2017-01-01

The paper describes the Generic Resolution Advisor and Conflict Evaluator (GRACE), a novel alerting and guidance algorithm that combines flexibility, robustness, and computational efficiency. GRACE is "generic" in that it makes no assumptions regarding temporal or spatial scales, aircraft performance, or its sensor and communication systems. Accordingly, GRACE is well suited to research applications where alerting and guidance is a central feature and requirements are fluid involving a wide range of aviation technologies. GRACE has been used at NASA in a number of real-time and fast-time experiments supporting evolving requirements of DAA research, including parametric studies, NAS-wide simulations, human-in-the-loop experiments, and live flight tests.

Do generic firms and the Spanish public purchaser respond to consumer price differences of generics under reference pricing?

PubMed

Puig-Junoy, Jaume; Moreno-Torres, Iván

2010-12-01

To assess the impact of competition on the consumer price and the average price paid by the National Health System (NHS) under reference pricing in the Spanish generic market. Descriptive analysis of the time trend in consumer prices before and after the application of reference pricing for the eight most sold active ingredients from 1997 to 2009. The entry of a generic at a lower consumer price than that of the brand-name pharmaceutical or the first generic does not cause a voluntary reduction in the consumer price of either the brand drug or the first generic, either before or after the application of RP. Generic entry at a lower consumer price than previously existing pharmaceuticals always causes a slight reduction in the average price paid by the NHS; however, the average price paid by the NHS is always notably higher than the lowest, the difference being greater in relative terms under reference pricing. The Spanish RP system results in very little consumer price competition between generic firms, price reduction thus being limited to regulatory measures. NHS purchases show little sensitivity to price differences between equivalent drugs priced at or below the reference price. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

40 CFR 721.2083 - Polysubstituted carbomonocyclic hydroxylamine (generic).

Code of Federal Regulations, 2010 CFR

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.

PubMed

Carrier, Michael A

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

Generic drugs in Brazil: known by many, used by few.

PubMed

Bertoldi, Andréa D; Barros, Aluísio J D; Hallal, Pedro C

2005-01-01

This study evaluated knowledge and use of generic drugs in a population-based sample of adults from a southern Brazilian city. The outcomes were: the proportion of generics in total medicines used; theoretical and practical knowledge about generics; and strategies used to buy medicines on medical prescriptions. The recall period for drug utilization was 15 days. The proportion of generics in total medicines was 3.9%. While 86.0% knew that generics cost less and 70.0% that the quality is similar to brand name medicines, only 57.0% knew any packaging characteristics that distinguish generics from other medicines. The highest proportion of generic drug utilization was in the antimicrobial pharmacological group. A brand name medicine (with a brand similar to the generic name) was mistakenly classified as a generic through photos by 48.0% of the interviewees. Among subjects who bought medicines in the 15-day period, 18.9% reported buying a generic, but this result should be interpreted with caution, because the population frequently fails to differentiate between generics and other medicines.

Characterization of heterogeneity in the Heletz sandstone from core to pore scale and quantification of its impact on multi-phase flow

DOE PAGES

Hingerl, Ferdinand F.; Yang, Feifei; Pini, Ronny; ...

2016-02-02

In this paper we present the results of an extensive multiscale characterization of the flow properties and structural and capillary heterogeneities of the Heletz sandstone. We performed petrographic, porosity and capillary pressure measurements on several subsamples. We quantified mm-scale heterogeneity in saturation distributions in a rock core during multi-phase flow using conventional X-ray CT scanning. Core-flooding experiments were conducted under reservoirs conditions (9 MPa, 50 °C) to obtain primary drainage and secondary imbibition relative permeabilities and residual trapping was analyzed and quantified. We provide parameters for relative permeability, capillary pressure and trapping models for further modeling studies. A synchrotron-based microtomographymore » study complements our cm- to mm-scale investigation by providing links between the micromorphology and mm-scale saturation heterogeneities.« less

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

PubMed

Edwards, Catherine

2010-07-01

SMi's 13th Annual Meeting on Generics, Supergenerics and Patent Strategies, held in London, included topics covering new trends in the generics field, the difficulties faced by companies in entering the generics market and recent developments in IP. This conference report highlights selected presentations on generics in India, protecting pharmaceutical products in China, changes in generics law and litigation in the US and Europe, challenges for market selection and entry for generics companies, the influence of changes in the healthcare market on the generics industry, supergenerics, and biosimilars.

Inner Core Tomography Under Africa

NASA Astrophysics Data System (ADS)

Irving, J. C. E.

2014-12-01

Hemispherical structure in the inner core has been observed using both normal mode and body wave data, but the more regional scale properties of the inner core are still the subject of ongoing debate. The nature of the vertical boundary regions between the eastern and western hemispheres will be an important constraint on dynamical processes at work in the inner core. With limited data available, earlier inner core studies defined each boundary using one line of longitude, but this may not be a sufficient description for what could be one of the inner core's most heterogeneous regions. Here, I present a large, hand-picked dataset of PKPbc-PKPdf differential travel times which sample the inner core under Africa, where the proposed position of one hemisphere boundary is located. The dataset contains polar, intermediate and equatorial rays through the inner core, and the presence of crossing raypaths makes regional-scale tomography of the inner core feasible. I invert the data to find regional variations in inner core anisotropy under different parts of Africa, and present both anisotropy and voigt isotropic velocity variations of this important portion of the inner core.

Generic Software Architecture for Launchers

NASA Astrophysics Data System (ADS)

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.

21 CFR 880.2720 - Patient scale.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Patient scale. (a) Identification. A patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scale. This generic device includes devices... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Patient scale. 880.2720 Section 880.2720 Food and...

40 CFR 721.324 - Alkoxylated acrylate polymer (generic).

Code of Federal Regulations, 2010 CFR

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...

40 CFR 721.2755 - Cycloaliphatic epoxy resin (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Cycloaliphatic epoxy resin (generic... Substances § 721.2755 Cycloaliphatic epoxy resin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cycloaliphatic epoxy resin (PMN...

40 CFR 721.2755 - Cycloaliphatic epoxy resin (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Cycloaliphatic epoxy resin (generic... Substances § 721.2755 Cycloaliphatic epoxy resin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cycloaliphatic epoxy resin (PMN...

40 CFR 721.2755 - Cycloaliphatic epoxy resin (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Cycloaliphatic epoxy resin (generic... Substances § 721.2755 Cycloaliphatic epoxy resin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cycloaliphatic epoxy resin (PMN...

40 CFR 721.2755 - Cycloaliphatic epoxy resin (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Cycloaliphatic epoxy resin (generic... Substances § 721.2755 Cycloaliphatic epoxy resin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cycloaliphatic epoxy resin (PMN...

40 CFR 721.2755 - Cycloaliphatic epoxy resin (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Cycloaliphatic epoxy resin (generic... Substances § 721.2755 Cycloaliphatic epoxy resin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cycloaliphatic epoxy resin (PMN...

40 CFR 721.324 - Alkoxylated acrylate polymer (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 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...

40 CFR 721.646 - Aminofluoran derivative (generic name).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Aminofluoran derivative (generic name... Substances § 721.646 Aminofluoran derivative (generic name). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aminofluoran derivative (PMN P...

40 CFR 721.2675 - Perfluoroalkyl epoxide (generic name).

Code of Federal Regulations, 2010 CFR

2010-07-01

... Substances § 721.2675 Perfluoroalkyl epoxide (generic name). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluoroalkyl epoxide (PMN P... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Perfluoroalkyl epoxide (generic name...

40 CFR 721.2675 - Perfluoroalkyl epoxide (generic name).

Code of Federal Regulations, 2011 CFR

2011-07-01

... Substances § 721.2675 Perfluoroalkyl epoxide (generic name). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluoroalkyl epoxide (PMN P... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Perfluoroalkyl epoxide (generic name...

40 CFR 721.2675 - Perfluoroalkyl epoxide (generic name).

Code of Federal Regulations, 2013 CFR

2013-07-01

... Substances § 721.2675 Perfluoroalkyl epoxide (generic name). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluoroalkyl epoxide (PMN P... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Perfluoroalkyl epoxide (generic name...

40 CFR 721.2675 - Perfluoroalkyl epoxide (generic name).

Code of Federal Regulations, 2012 CFR

2012-07-01

... Substances § 721.2675 Perfluoroalkyl epoxide (generic name). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluoroalkyl epoxide (PMN P... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Perfluoroalkyl epoxide (generic name...

40 CFR 721.2675 - Perfluoroalkyl epoxide (generic name).

Code of Federal Regulations, 2014 CFR

2014-07-01

... Substances § 721.2675 Perfluoroalkyl epoxide (generic name). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluoroalkyl epoxide (PMN P... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Perfluoroalkyl epoxide (generic name...

40 CFR 721.324 - Alkoxylated acrylate polymer (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 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...

40 CFR 721.324 - Alkoxylated acrylate polymer (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 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...

40 CFR 721.324 - Alkoxylated acrylate polymer (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 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.

PubMed

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.

Need for multicriteria evaluation of generic drug policies.

PubMed

Kaló, Zoltán; Holtorf, Anke-Peggy; Alfonso-Cristancho, Rafael; Shen, Jie; Ágh, Tamás; Inotai, András; Brixner, Diana

2015-03-01

Policymakers tend to focus on improving patented drug policies because they are under pressure from patients, physicians, and manufacturers to increase access to novel therapies. The success of pharmaceutical innovation over the last few decades has led to the availability of many off-patent drugs to treat disease areas with the greatest public health need. Therefore, the success of public health programs in improving the health status of the total population is highly dependent on the efficiency of generic drug policies. The objective of this article was to explore factors influencing the true efficiency of generic prescription drug policies in supporting public health initiatives in the developed world. Health care decision makers often assess the efficiency of generic drug policies by the level of price erosion and market share of generics. Drug quality, bioequivalence, in some cases drug formulations, supply reliability, medical adherence and persistence, health outcomes, and nondrug costs, however, are also attributes of success for generic drug policies. Further methodological research is needed to measure and improve the efficiency of generic drug policies. This also requires extension of the evidence base of the impact of generic drugs, partly based on real-world evidence. Multicriteria decision analysis may assist policymakers and researchers to evaluate the true value of generic drugs. Copyright © 2015. Published by Elsevier Inc.

Temporal Change of Seismic Earth's Inner Core Phases: Inner Core Differential Rotation Or Temporal Change of Inner Core Surface?

NASA Astrophysics Data System (ADS)

Yao, J.; Tian, D.; Sun, L.; Wen, L.

2017-12-01

Since Song and Richards [1996] first reported seismic evidence for temporal change of PKIKP wave (a compressional wave refracted in the inner core) and proposed inner core differential rotation as its explanation, it has generated enormous interests in the scientific community and the public, and has motivated many studies on the implications of the inner core differential rotation. However, since Wen [2006] reported seismic evidence for temporal change of PKiKP wave (a compressional wave reflected from the inner core boundary) that requires temporal change of inner core surface, both interpretations for the temporal change of inner core phases have existed, i.e., inner core rotation and temporal change of inner core surface. In this study, we discuss the issue of the interpretation of the observed temporal changes of those inner core phases and conclude that inner core differential rotation is not only not required but also in contradiction with three lines of seismic evidence from global repeating earthquakes. Firstly, inner core differential rotation provides an implausible explanation for a disappearing inner core scatterer between a doublet in South Sandwich Islands (SSI), which is located to be beneath northern Brazil based on PKIKP and PKiKP coda waves of the earlier event of the doublet. Secondly, temporal change of PKIKP and its coda waves among a cluster in SSI is inconsistent with the interpretation of inner core differential rotation, with one set of the data requiring inner core rotation and the other requiring non-rotation. Thirdly, it's not reasonable to invoke inner core differential rotation to explain travel time change of PKiKP waves in a very small time scale (several months), which is observed for repeating earthquakes in Middle America subduction zone. On the other hand, temporal change of inner core surface could provide a consistent explanation for all the observed temporal changes of PKIKP and PKiKP and their coda waves. We conclude that

Generic tacrolimus in solid organ transplantation.

PubMed

Taube, D; Jones, G; O'Beirne, J; Wennberg, L; Connor, A; Rasmussen, A; Backman, L

2014-05-01

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 are similar in quality, safety, and efficacy to their approved innovator drugs. There are data available for three generic brands, tacrolimus (Intas), tacrolimus (PharOS), and tacrolimus (Sandoz). Bioequivalence has been demonstrated for generic tacrolimus (Sandoz) within a narrow therapeutic range to its 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 SOT patients, including lung and heart recipients. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Electronic Structure Calculations and Adaptation Scheme in Multi-core Computing Environments

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

Seshagiri, Lakshminarasimhan; Sosonkina, Masha; Zhang, Zhao

2009-05-20

Multi-core processing environments have become the norm in the generic computing environment and are being considered for adding an extra dimension to the execution of any application. The T2 Niagara processor is a very unique environment where it consists of eight cores having a capability of running eight threads simultaneously in each of the cores. Applications like General Atomic and Molecular Electronic Structure (GAMESS), used for ab-initio molecular quantum chemistry calculations, can be good indicators of the performance of such machines and would be a guideline for both hardware designers and application programmers. In this paper we try to benchmarkmore » the GAMESS performance on a T2 Niagara processor for a couple of molecules. We also show the suitability of using a middleware based adaptation algorithm on GAMESS on such a multi-core environment.« less

Synthesis: Deriving a Core Set of Recommendations to Optimize Diabetes Care on a Global Scale.

PubMed

Mechanick, Jeffrey I; Leroith, Derek

2015-01-01

Diabetes afflicts 382 million people worldwide, with increasing prevalence rates and adverse effects on health, well-being, and society in general. There are many drivers for the complex presentation of diabetes, including environmental and genetic/epigenetic factors. The aim was to synthesize a core set of recommendations from information from 14 countries that can be used to optimize diabetes care on a global scale. Information from 14 papers in this special issue of Annals of Global Health was reviewed, analyzed, and sorted to synthesize recommendations. PubMed was searched for relevant studies on diabetes and global health. Key findings are as follows: (1) Population-based transitions distinguish region-specific diabetes care; (2) biological drivers for diabetes differ among various populations and need to be clarified scientifically; (3) principal resource availability determines quality-of-care metrics; and (4) governmental involvement, independent of economic barriers, improves the contextualization of diabetes care. Core recommendations are as follows: (1) Each nation should assess region-specific epidemiology, the scientific evidence base, and population-based transitions to establish risk-stratified guidelines for diagnosis and therapeutic interventions; (2) each nation should establish a public health imperative to provide tools and funding to successfully implement these guidelines; and (3) each nation should commit to education and research to optimize recommendations for a durable effect. Systematic acquisition of information about diabetes care can be analyzed, extrapolated, and then used to provide a core set of actionable recommendations that may be further studied and implemented to improve diabetes care on a global scale. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

40 CFR 721.10332 - Lithium metal phosphate (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Lithium metal phosphate (generic). 721... Substances § 721.10332 Lithium metal phosphate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as lithium metal phosphate (PMN P...

40 CFR 721.10332 - Lithium metal phosphate (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Lithium metal phosphate (generic). 721... Substances § 721.10332 Lithium metal phosphate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as lithium metal phosphate (PMN P...

40 CFR 721.10332 - Lithium metal phosphate (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Lithium metal phosphate (generic). 721... Substances § 721.10332 Lithium metal phosphate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as lithium metal phosphate (PMN P...

40 CFR 721.5908 - Modified phenolic resin (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Modified phenolic resin (generic). 721... Substances § 721.5908 Modified phenolic resin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified phenolic resin (PMN P...

40 CFR 721.5905 - Modified phenolic resin (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Modified phenolic resin (generic). 721... Substances § 721.5905 Modified phenolic resin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a modified phenolic resin (PMN...

40 CFR 721.1680 - Substituted benzoic acid (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Substituted benzoic acid (generic... Substances § 721.1680 Substituted benzoic acid (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted benzoic acid (PMN P...

Generic Penetration of the SSRI Market.

PubMed

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.

Generic Penetration of the SSRI Market

PubMed Central

2008-01-01

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® 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. PMID:19727306

Is generic rifaximin still a poorly absorbed antibiotic? A comparison of branded and generic formulations in healthy volunteers.

PubMed

Blandizzi, Corrado; Viscomi, Giuseppe Claudio; Marzo, Antonio; Scarpignato, Carmelo

2014-07-01

Rifaximin is an antibiotic, locally acting in the gastrointestinal tract, which may exist in different crystal as well as amorphous forms. The branded rifaximin formulation contains the polymorph rifaximin-α, whose systemic bioavailability is very limited. This study was performed to compare the pharmacokinetics of this formulation with that of a generic product, whose composition in terms of solid state forms of the active pharmaceutical ingredient was found to be different. Two tablets (2×200mg) of branded and generic formulations were given to 24 healthy volunteers of either sex, according to a single-blind, randomized, two-treatment, single-dose, two-period, cross-over design. Plasma and urinary samples were collected at preset times (for 24h or 48h, respectively) after dosing, and assayed for rifaximin concentrations by high-performance liquid chromatography-mass spectrometry. Rifaximin plasma and urine concentration-time profiles showed relevant differences when generic and branded rifaximin were compared. Most pharmacokinetic parameters were significantly higher after administration of generic rifaximin than after rifaximin-α. In particular, the differences for Cmax, AUC and cumulative urinary excretion between the generic formulation and the branded product ranged from 165% to 345%. The few adverse events recorded were not serious and not related to study medications. The results of the present investigation demonstrate different systemic bioavailability of generic and branded formulations of rifaximin. As a consequence, the therapeutic results obtained with rifaximin-α should not be translated sic et simpliciter to the generic formulations of rifaximin, which do not claim containing only rifaximin-α and will display significantly higher systemic absorption in both health and disease. Copyright © 2014 Elsevier Ltd. All rights reserved.

[Generic drugs in the treatment of epilepsy].

PubMed

González de Dios, J; Ochoa-Sangrador, C; Sempere, A P

We discuss some controversial aspects with prescription of generic drugs (GD) and the problems concerning bioequivalence, mainly in the case of drugs with non-linear pharmacokinetics and/or narrow therapeutic rank, like the antiepileptic drugs (AED). There is considerable debate about GD in the treatment of epilepsy, with clearly advantages (cost saving) and disadvantages (loss of seizure control or drug toxicity) in prescribing generics anticonvulsants. We make a systematic review of the literature in primary (PubMed) and secondary (Tripdatabase and Cochrane Library) bibliographic databases in relation to GD and AED. The main information is about classical AED (phenytoin, carbamazepine, valproic acid and primidone) and we don't found studies in this area about the new AED. The level of evidence is, generally, weak, based on case-series and expert opinion without explicit critical appraisal (except in phenytoin with level of evidence moderate, based on some analytical studies). In Spain, at this moment, there are only two generic AED, one-classical (carbamazepine) and one-new (gabapentin). The American Academy of Neurology and Epilepsy Foundation maintains that the individual and physician should be notified and give their consent before a switch in antiepileptic medications is made, whether it involves generic substitution for brand name products, or generic to generic substitutions.

40 CFR 721.10628 - Mixed metal oxalate (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Mixed metal oxalate (generic). 721... Substances § 721.10628 Mixed metal oxalate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxalate (PMN P-12-432...

40 CFR 721.10631 - Mixed metal borate (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Mixed metal borate (generic). 721... Substances § 721.10631 Mixed metal borate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal borate (PMN P-12-64...

40 CFR 721.10628 - Mixed metal oxalate (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Mixed metal oxalate (generic). 721... Substances § 721.10628 Mixed metal oxalate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxalate (PMN P-12-432...

40 CFR 721.10631 - Mixed metal borate (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Mixed metal borate (generic). 721... Substances § 721.10631 Mixed metal borate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal borate (PMN P-12-64...

Generic Drugs: The Same Medicine for Less Money

MedlinePlus

Generic Drugs: The Same Medicine for Less Money What is a generic drug? A generic is a copy of a brand-name drug. A brand- name drug has a patent. When ... benefit to your health, and you will save money. 7KH IHGHUDO )RRG DQG 'UXJ $GPLQLVWUDWLRQ )'$ UHJXODWHV ERWK ...

40 CFR 721.6005 - Rare earth phosphate (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Rare earth phosphate (generic). 721... Substances § 721.6005 Rare earth phosphate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as rare earth phophate (PMNs P-99...

40 CFR 721.6005 - Rare earth phosphate (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Rare earth phosphate (generic). 721... Substances § 721.6005 Rare earth phosphate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as rare earth phophate (PMNs P-99...

40 CFR 721.6005 - Rare earth phosphate (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Rare earth phosphate (generic). 721... Substances § 721.6005 Rare earth phosphate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as rare earth phophate (PMNs P-99...

40 CFR 721.6005 - Rare earth phosphate (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Rare earth phosphate (generic). 721... Substances § 721.6005 Rare earth phosphate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as rare earth phophate (PMNs P-99...

40 CFR 721.6005 - Rare earth phosphate (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Rare earth phosphate (generic). 721... Substances § 721.6005 Rare earth phosphate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as rare earth phophate (PMNs P-99...

Developing multiple-choices test items as tools for measuring the scientific-generic skills on solar system

NASA Astrophysics Data System (ADS)

Bhakti, Satria Seto; Samsudin, Achmad; Chandra, Didi Teguh; Siahaan, Parsaoran

2017-05-01

The aim of research is developing multiple-choices test items as tools for measuring the scientific of generic skills on solar system. To achieve the aim that the researchers used the ADDIE model consisting Of: Analyzing, Design, Development, Implementation, dan Evaluation, all of this as a method research. While The scientific of generic skills limited research to five indicator including: (1) indirect observation, (2) awareness of the scale, (3) inference logic, (4) a causal relation, and (5) mathematical modeling. The participants are 32 students at one of junior high schools in Bandung. The result shown that multiple-choices that are constructed test items have been declared valid by the expert validator, and after the tests show that the matter of developing multiple-choices test items be able to measuring the scientific of generic skills on solar system.

Reference pricing with endogenous generic entry.

PubMed

Brekke, Kurt R; Canta, Chiara; Straume, Odd Rune

2016-12-01

Reference pricing intends to reduce pharmaceutical expenditures by increasing demand elasticity and stimulating generic competition. We develop a novel model where a brand-name producer competes in prices with several generics producers in a market with brand-biased and brand-neutral consumers. Comparing with coinsurance, we show that reference pricing, contrary to policy makers' intentions, discourages generic entry, as it induces the brand-name producer to price more aggressively. Thus, the net effect of reference pricing on drug prices is ambiguous, implying that reference pricing can be counterproductive in reducing expenditures. However, under price regulation, we show that reference pricing may stimulate generic entry, since a binding price cap weakens the aggressive price response by the brand-name producer. This may explain mixed empirical results on the competitive effects of reference pricing. Finally, we show that reference pricing may be welfare improving when accounting for brand preferences despite its adverse effects on entry and prices. Copyright © 2016 Elsevier B.V. All rights reserved.

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

PubMed

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

2017-01-01

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

cFE/CFS (Core Flight Executive/Core Flight System)

NASA Technical Reports Server (NTRS)

Wildermann, Charles P.

2008-01-01

This viewgraph presentation describes in detail the requirements and goals of the Core Flight Executive (cFE) and the Core Flight System (CFS). The Core Flight Software System is a mission independent, platform-independent, Flight Software (FSW) environment integrating a reusable core flight executive (cFE). The CFS goals include: 1) Reduce time to deploy high quality flight software; 2) Reduce project schedule and cost uncertainty; 3) Directly facilitate formalized software reuse; 4) Enable collaboration across organizations; 5) Simplify sustaining engineering (AKA. FSW maintenance); 6) Scale from small instruments to System of Systems; 7) Platform for advanced concepts and prototyping; and 7) Common standards and tools across the branch and NASA wide.

Defining and Comparing Generic Competences in Higher Education

ERIC Educational Resources Information Center

Kallioinen, Outi

2010-01-01

In this article the author discusses the importance of defining generic competences in alignment with the European definitions. As a case study the generic competences defined by Laurea University of Applied Sciences are compared with European definitions of generic competences. The purpose is to open up the various perspectives within this…

40 CFR 721.4610 - Mixed metal oxides (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Mixed metal oxides (generic). 721.4610... Substances § 721.4610 Mixed metal oxides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxides (PMN P-98-0002...

40 CFR 721.10006 - Mixed metal oxide (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Mixed metal oxide (generic). 721.10006... Substances § 721.10006 Mixed metal oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxide (PMN P-99-511...

40 CFR 721.4610 - Mixed metal oxides (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Mixed metal oxides (generic). 721.4610... Substances § 721.4610 Mixed metal oxides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxides (PMN P-98-0002...

40 CFR 721.10006 - Mixed metal oxide (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Mixed metal oxide (generic). 721.10006... Substances § 721.10006 Mixed metal oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxide (PMN P-99-511...

40 CFR 721.4610 - Mixed metal oxides (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Mixed metal oxides (generic). 721.4610... Substances § 721.4610 Mixed metal oxides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxides (PMN P-98-0002...

40 CFR 721.4610 - Mixed metal oxides (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Mixed metal oxides (generic). 721.4610... Substances § 721.4610 Mixed metal oxides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxides (PMN P-98-0002...

40 CFR 721.10006 - Mixed metal oxide (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Mixed metal oxide (generic). 721.10006... Substances § 721.10006 Mixed metal oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxide (PMN P-99-511...

40 CFR 721.4610 - Mixed metal oxides (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Mixed metal oxides (generic). 721.4610... Substances § 721.4610 Mixed metal oxides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxides (PMN P-98-0002...

40 CFR 721.10006 - Mixed metal oxide (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Mixed metal oxide (generic). 721.10006... Substances § 721.10006 Mixed metal oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxide (PMN P-99-511...

Developing Competitive and Sustainable Polish Generic Medicines Market

PubMed Central

Simoens, Steven

2009-01-01

Aim To descriptively analyze the policy environment surrounding the Polish generic medicines retail market. Method The policy analysis was based on an international literature review. Also, a simulation exercise was carried out to compute potential savings from substituting generic for originator medicines in Poland using IMS Health pharmaceutical intelligence data. Results Poland has a mature, high-volume, low-value generic medicines market, primarily driven by the establishment of the reference price at the price of the cheapest medicine in combination with pricing regulation and the low level of medicine prices. The practice of discounting in the distribution chain implies that the National Health Fund and patients do not capture the potential savings from a generic medicines market where companies compete on price. This high-volume market has benefited in the past from the limited availability of originator medicines and a short data exclusivity period, even though there are no incentives for physicians to prescribe generic medicines and a financial disincentive for pharmacists to dispense generic medicines. Increased generic substitution would be expected to reduce public expenditure on originator medicines by 21%. Conclusion To develop a competitive and sustainable market, Poland needs to consider moving away from competition by discount to competition by price. This could be achieved by replacing maximum distribution margins by fixed margins. Also, Poland may wish to raise reference prices as a temporary measure to boost market entry for medicine classes with few generic medicines. PMID:19839067

Developing competitive and sustainable Polish generic medicines market.

PubMed

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

NASA Technical Reports Server (NTRS)

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.

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

PubMed Central

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 common and optimized age scale for Antarctic ice cores

NASA Astrophysics Data System (ADS)

Parrenin, F.; Veres, D.; Landais, A.; Bazin, L.; Lemieux-Dudon, B.; Toye Mahamadou Kele, H.; Wolff, E.; Martinerie, P.

2012-04-01

Dating ice cores is a complex problem because 1) there is a age shift between the gas bubbles and the surrounding ice 2) there are many different ice cores which can be synchronized with various proxies and 3) there are many methods to date the ice and the gas bubbles, each with advantages and drawbacks. These methods fall into the following categories: 1) Ice flow (for the ice) and firn densification modelling (for the gas bubbles); 2) Comparison of ice core proxies with insolation variations (so-called orbital tuning methods); 3) Comparison of ice core proxies with other well dated archives; 4) Identification of well-dated horizons, such as tephra layers or geomagnetic anomalies. Recently, an new dating tool has been developped (DATICE, Lemieux-Dudon et al., 2010), to take into account all the different dating information into account and produce a common and optimal chronology for ice cores with estimated confidence intervals. In this talk we will review the different dating information for Antarctic ice cores and show how the DATICE tool can be applied.

Generic Skills. Keys to Job Performance.

ERIC Educational Resources Information Center

Smith, Arthur De W.

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

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

PubMed Central

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

2014-01-01

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

40 CFR 721.5548 - Mixed metal oxide (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Mixed metal oxide (generic). 721.5548... Substances § 721.5548 Mixed metal oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a mixed metal oxide (PMN P-97-956) is...

40 CFR 721.5548 - Mixed metal oxide (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Mixed metal oxide (generic). 721.5548... Substances § 721.5548 Mixed metal oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a mixed metal oxide (PMN P-97-956) is...

40 CFR 721.5548 - Mixed metal oxide (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Mixed metal oxide (generic). 721.5548... Substances § 721.5548 Mixed metal oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a mixed metal oxide (PMN P-97-956) is...

40 CFR 721.5548 - Mixed metal oxide (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Mixed metal oxide (generic). 721.5548... Substances § 721.5548 Mixed metal oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a mixed metal oxide (PMN P-97-956) is...

40 CFR 721.5548 - Mixed metal oxide (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Mixed metal oxide (generic). 721.5548... Substances § 721.5548 Mixed metal oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a mixed metal oxide (PMN P-97-956) is...

A developmental analysis of generic nouns in Southern Peruvian Quechua.

PubMed

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.

A developmental analysis of generic nouns in Southern Peruvian Quechua

PubMed Central

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. PMID:21779154

Hollow-Core Fiber Lamp

NASA Technical Reports Server (NTRS)

Yi, Lin (Inventor); Tjoelker, Robert L. (Inventor); Burt, Eric A. (Inventor); Huang, Shouhua (Inventor)

2016-01-01

Hollow-core capillary discharge lamps on the millimeter or sub-millimeter scale are provided. The hollow-core capillary discharge lamps achieve an increased light intensity ratio between 194 millimeters (useful) and 254 millimeters (useless) light than conventional lamps. The capillary discharge lamps may include a cone to increase light output. Hollow-core photonic crystal fiber (HCPCF) may also be used.

Novel laboratory methods for determining the fine scale electrical resistivity structure of core

NASA Astrophysics Data System (ADS)

Haslam, E. P.; Gunn, D. A.; Jackson, P. D.; Lovell, M. A.; Aydin, A.; Prance, R. J.; Watson, P.

2014-12-01

High-resolution electrical resistivity measurements are made on saturated rocks using novel laboratory instrumentation and multiple electrical voltage measurements involving in principle a four-point electrode measurement but with a single, moving electrode. Flat, rectangular core samples are scanned by varying the electrode position over a range of hundreds of millimetres with an accuracy of a tenth of a millimetre. Two approaches are tested involving a contact electrode and a non-contact electrode arrangement. The first galvanic method uses balanced cycle switching of a floating direct current (DC) source to minimise charge polarisation effects masking the resistivity distribution related to fine scale structure. These contacting electrode measurements are made with high common mode noise rejection via differential amplification with respect to a reference point within the current flow path. A computer based multifunction data acquisition system logs the current through the sample and voltages along equipotentials from which the resistivity measurements are derived. Multiple measurements are combined to create images of the surface resistivity structure, with variable spatial resolution controlled by the electrode spacing. Fine scale sedimentary features and open fractures in saturated rocks are interpreted from the measurements with reference to established relationships between electrical resistivity and porosity. Our results successfully characterise grainfall lamination and sandflow cross-stratification in a brine saturated, dune bedded core sample representative of a southern North Sea reservoir sandstone, studied using the system in constant current, variable voltage mode. In contrast, in a low porosity marble, identification of open fracture porosity against a background very low matrix porosity is achieved using the constant voltage, variable current mode. This new system is limited by the diameter of the electrode that for practical reasons can only be

redGEM: Systematic reduction and analysis of genome-scale metabolic reconstructions for development of consistent core metabolic models

PubMed Central

Ataman, Meric

2017-01-01

Genome-scale metabolic reconstructions have proven to be valuable resources in enhancing our understanding of metabolic networks as they encapsulate all known metabolic capabilities of the organisms from genes to proteins to their functions. However the complexity of these large metabolic networks often hinders their utility in various practical applications. Although reduced models are commonly used for modeling and in integrating experimental data, they are often inconsistent across different studies and laboratories due to different criteria and detail, which can compromise transferability of the findings and also integration of experimental data from different groups. In this study, we have developed a systematic semi-automatic approach to reduce genome-scale models into core models in a consistent and logical manner focusing on the central metabolism or subsystems of interest. The method minimizes the loss of information using an approach that combines graph-based search and optimization methods. The resulting core models are shown to be able to capture key properties of the genome-scale models and preserve consistency in terms of biomass and by-product yields, flux and concentration variability and gene essentiality. The development of these “consistently-reduced” models will help to clarify and facilitate integration of different experimental data to draw new understanding that can be directly extendable to genome-scale models. PMID:28727725

Magnetic Fields in the Massive Dense Cores of the DR21 Filament: Weakly Magnetized Cores in a Strongly Magnetized Filament

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

Ching, Tao-Chung; Lai, Shih-Ping; Zhang, Qizhou

We present Submillimeter Array 880 μ m dust polarization observations of six massive dense cores in the DR21 filament. The dust polarization shows complex magnetic field structures in the massive dense cores with sizes of 0.1 pc, in contrast to the ordered magnetic fields of the parsec-scale filament. The major axes of the massive dense cores appear to be aligned either parallel or perpendicular to the magnetic fields of the filament, indicating that the parsec-scale magnetic fields play an important role in the formation of the massive dense cores. However, the correlation between the major axes of the cores andmore » the magnetic fields of the cores is less significant, suggesting that during the core formation, the magnetic fields below 0.1 pc scales become less important than the magnetic fields above 0.1 pc scales in supporting a core against gravity. Our analysis of the angular dispersion functions of the observed polarization segments yields a plane-of-sky magnetic field strength of 0.4–1.7 mG for the massive dense cores. We estimate the kinematic, magnetic, and gravitational virial parameters of the filament and the cores. The virial parameters show that the gravitational energy in the filament dominates magnetic and kinematic energies, while the kinematic energy dominates in the cores. Our work suggests that although magnetic fields may play an important role in a collapsing filament, the kinematics arising from gravitational collapse must become more important than magnetic fields during the evolution from filaments to massive dense cores.« less

The risks and costs of multiple-generic substitution of topiramate.

PubMed

Duh, M S; Paradis, P E; Latrémouille-Viau, D; Greenberg, P E; Lee, S P; Durkin, M B; Wan, G J; Rupnow, M F T; LeLorier, J

2009-06-16

To investigate clinical and economic consequences following generic substitution of one vs multiple generics of topiramate (Topamax; Ortho-McNeil Neurologics, Titusville, NJ). Medical and pharmacy claims data of Régie de l'Assurance-Maladie du Québec from January 2006 to October 2007 were used. Patients with epilepsy treated with topiramate were selected. An open-cohort design was used to classify the observation period into periods of brand, single-generic, and multiple-generic use. One-year generic-switch and switchback-to-brand rates were estimated using Kaplan-Meier methodology. Medical resource utilization and costs were compared among the three periods using multivariate regression analysis. In total, 948 patients were observed during 1,105 person-years of brand use, 233 person-years of single-generic use, and 92 person-years of multiple-generic use. A total of 23% of generic users received at least two different generic versions. Compared to brand use, multiple-generic use was associated with higher utilization of other prescription drugs (incidence rate ratio [IRR] = 1.27, 95% confidence interval [CI] = 1.24-1.31), higher hospitalization rates (0.48 vs 0.83 visit/person-year, IRR = 1.65, 95% CI = 1.28-2.13), and longer hospital stays (2.6 vs 3.9 days/person-year, IRR = 1.43, 95% CI = 1.27-1.60), but the effect was less pronounced in single-generic use (hospitalization: IRR = 1.08, 95% CI = 0.88-1.34, length of stay: IRR = 1.12, 95% CI = 1.03-1.23). The risk of head injury or fracture was nearly three times higher (hazard ratio = 2.84, 95% CI = 1.24-6.48) following a generic-to-generic switch compared to brand use. The total annualized health care cost per patient was higher in the multiple-generic than brand periods by C$1,716 (cost ratio = 1.21, p = 0.0420). Multiple-generic substitution of topiramate was significantly associated with negative outcomes, such as hospitalizations and injuries, and increased health care costs.

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

PubMed

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

A case study in generic drug use: should there be risk adjustment in incentive payments for the use of generic medications?

PubMed

Walton, Surrey M; Rash, Christine; Lambert, Bruce L; Galanter, William L

2014-11-01

Encouraging generic drug use has reduced health care costs for payers and consumers, but the availability of therapeutically interchangeable medications or generic medications of choice is not equal across disease states. The extent to which systems of care are able to substitute with generics is not well understood.  To (a) define and measure the maximum generic rate (MGR) of currently prescribed drugs within an academic medical group in and (b) illustrate differences across drugs associated with selected underlying diseases.   Prescription claims data were examined from an academic medical group in Chicago, Illinois. Based on pharmacologic and therapeutic criteria, drugs were classified into 2 categories-potentially substitutable and not potentially substitutable-based on whether the drugs are branded forms of the same chemical entities that are available as generics or are therapeutically interchangeable with other medications that have different chemical compositions but the same mechanisms of action and potential efficacy. A medication was considered potentially substitutable if it (a) did not have a narrow therapeutic index as defined by the FDA; (b) did not belong to 1 of 6 protected classes of drugs in the Medicare D provisions; (c) was substitutable with a generic medication containing the same chemical entity; or (d) was therapeutically interchangeable with a therapeutically equivalent medication. MGR was defined as the percentage of prescriptions that could potentially be prescribed in generic form. This rate was examined overall and across drugs known to be associated with illustrative diseases including hypertension, diabetes mellitus, and obstructive lung diseases.   The MGR ranged from 100% for drugs used in hypertension to 26.7% for drugs used in obstructive lung diseases. The MGR was 83.6%.  Payers wishing to promote generic substitution should incorporate the potential for substitution of clinically appropriate generic medications as part of

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

PubMed

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.

Innovation strategies for generic drug companies: moving into supergenerics.

PubMed

Ross, Malcolm S F

2010-04-01

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

40 CFR 721.10524 - Fluorinated alkylsulfonamidol urethane polymer (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... polymer (generic). 721.10524 Section 721.10524 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10524 Fluorinated alkylsulfonamidol urethane polymer (generic). (a... generically as fluorinated alkylsulfonamidol urethane polymer (PMN P-11-384) is subject to reporting under...

40 CFR 721.10524 - Fluorinated alkylsulfonamidol urethane polymer (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... polymer (generic). 721.10524 Section 721.10524 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10524 Fluorinated alkylsulfonamidol urethane polymer (generic). (a... generically as fluorinated alkylsulfonamidol urethane polymer (PMN P-11-384) is subject to reporting under...

Floquet-Magnus theory and generic transient dynamics in periodically driven many-body quantum systems

NASA Astrophysics Data System (ADS)

Kuwahara, Tomotaka; Mori, Takashi; Saito, Keiji

2016-04-01

This work explores a fundamental dynamical structure for a wide range of many-body quantum systems under periodic driving. Generically, in the thermodynamic limit, such systems are known to heat up to infinite temperature states in the long-time limit irrespective of dynamical details, which kills all the specific properties of the system. In the present study, instead of considering infinitely long-time scale, we aim to provide a general framework to understand the long but finite time behavior, namely the transient dynamics. In our analysis, we focus on the Floquet-Magnus (FM) expansion that gives a formal expression of the effective Hamiltonian on the system. Although in general the full series expansion is not convergent in the thermodynamics limit, we give a clear relationship between the FM expansion and the transient dynamics. More precisely, we rigorously show that a truncated version of the FM expansion accurately describes the exact dynamics for a certain time-scale. Our theory reveals an experimental time-scale for which non-trivial dynamical phenomena can be reliably observed. We discuss several dynamical phenomena, such as the effect of small integrability breaking, efficient numerical simulation of periodically driven systems, dynamical localization and thermalization. Especially on thermalization, we discuss a generic scenario on the prethermalization phenomenon in periodically driven systems.

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

PubMed

Simoens, Steven

2008-01-01

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

Generic Language Facilitates Children's Cross-Classification

ERIC Educational Resources Information Center

Nguyen, Simone P.; Gelman, A.

2012-01-01

Four studies examined the role of generic language in facilitating 4- and 5-year-old children's ability to cross-classify. Participants were asked to classify an item into a familiar (taxonomic or script) category, then cross-classify it into a novel (script or taxonomic) category with the help of a clue expressed in either generic or specific…

Strategies That Delay Market Entry of Generic Drugs.

PubMed

Vokinger, Kerstin Noëlle; Kesselheim, Aaron S; Avorn, Jerry; Sarpatwari, Ameet

2017-11-01

Increasing prescription drug expenditures in the United States are primarily driven by high brand-name drug prices. Although generic competition helps lower drug prices, manufacturers of brand-name drugs often work to delay the availability of generic versions of their products. Strategies to forestall generic competition include patenting peripheral aspects of a drug or modified formulations that do not add clinical value, paying generic manufacturers to settle lawsuits challenging the validity of patents on brand-name drugs ("reverse payment" settlements), denying generic manufacturers access to drug samples necessary for bioequivalence testing, misusing risk evaluation and mitigation strategies, and filing citizen petitions with the US Food and Drug Administration (FDA). To address such tactics, the federal government can interpret existing patenting standards more strictly and promote certain types of patent challenges to ensure that patents are granted or upheld only for true innovations. Congress can enact pending legislation that would help discourage reverse payment settlements and compel brand-name manufacturers to share drug samples for bioequivalence testing. Finally, the FDA can provide earlier guidance on bioequivalence determinations for complex generic products and adopt the presumption that late-filed citizen petitions should be summarily rejected.

Knowledge, perceptions and use of generic drugs: a cross sectional study

PubMed Central

de Lira, Claudio Andre Barbosa; Oliveira, Jéssica Nathalia Soares; Andrade, Marília dos Santos; Vancini-Campanharo, Cássia Regina; Vancini, Rodrigo Luiz

2014-01-01

Objective To assess the level of knowledge, perceptions and usage profile for generic drugs among laypersons. Methods A cross-sectional study was conducted with 278 volunteers (180 women and 98 men, aged 37.1±15.8 years). A questionnaire was drawn up with questions on their use, perceptions and knowledge of generic drugs. Results Most respondents (99.6%) knew that generic drugs exist, but only 48.6% were able to define them correctly, while 78.8% of the respondents had some information about generics. This information was obtained mainly through television (49.3%). In terms of generic drug characteristics, 79.1% stated that they were confident about their efficacy, 74.8% believed that generic drugs have the same effect as branded medications, 88.8% said that generics were priced lower than branded medications, and 80.2% stated that they bought generic drugs because of price. With regard to drugs prescribed by medical practitioners, 17.6% of the participants said that their doctors never prescribed generics and only 7.5% confirmed that their doctors always prescribed generics. Conclusion For the lay public, the sample in this study has sufficient knowledge of generic drugs in terms of definition, efficacy and cost. Consequently, the volunteers interviewed are very likely to use generics. Furthermore, the results of this study indicate that programs should be implemented in order to boost generic drug prescriptions by medical practitioners. PMID:25295444

Impact of generic substitution decision support on electronic prescribing behavior.

PubMed

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.

Impact of generic substitution decision support on electronic prescribing behavior

PubMed Central

Chen, Qingxia; Johnson, Kevin B

2010-01-01

Objective To evaluate the impact of generic substitution decision support on electronic (e-) prescribing of generic medications. Design 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. Measurements Proportion of generic medications prescribed before and after the intervention, evaluated over time, and compared with a sample of prescriptions generated without e-prescribing. Results 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. Conclusion Implementation of generic substitution decision support was associated with dramatic and sustained improvements in the rate of outpatient generic e-prescribing across all specialties. PMID:20962131

Inner Core Imaging Using P'P'

NASA Astrophysics Data System (ADS)

Day, E. A.; Ward, J. A.; Bastow, I. D.; Irving, J. C. E.

2016-12-01

The Earth's inner core is a surprisingly complex region of our planet. Simple models of inner core solidification and evolution would lead us to expect a layered structure, which has "frozen in" in information about the state of the core at the time of solidification. However, seismic observations of Earth's inner core are not dominated by a radial "tree-ring" like pattern, but instead have revealed a hemispherical dichotomy in addition to depth dependent variations. There is a degree-one structure in isotropic and anisotropic velocities and in attenuation between the so-called eastern and western hemispheres of the inner core, with different depth distributions proposed for these varying phenomena. A range of mechanisms have been proposed to explain the hemispherical differences. These include models that require differences between the two hemispheres at the time of formation, post-solidification texturing, convection in the inner core, or hybrid mechanisms. Regional observations of the inner core suggest that a simple division between East and West may not be able to fully capture the structure present in the inner core. More detailed seismic observations will help us to understand the puzzle of the inner core's evolution. In this study we focus on updating observations of the seismic phase P'P', an inner core sensitive body wave with a more complex path than those typically used to study the inner core. By making new measurements of P'P' we illuminate new regions of the core with a high frequency phase that is sensitive to small scale structures. We examine the differential travel times of the different branches of P'P' (PKIKPPKIKP and PKPPKP), comparing the arrival time of inner core turning branch, P'P'df, with the arrival times of branches that turn in the outer core. P'P' is a relatively small amplitude phase, so we use both linear and non-linear stacking methods to make observations of the P'P' signals. These measurements are sensitive to the broad scale

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

PubMed

Hollis, Aidan

2002-12-01

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

Performance of four turbulence closure models implemented using a generic length scale method

USGS Publications Warehouse

Warner, J.C.; Sherwood, C.R.; Arango, H.G.; Signell, R.P.

2005-01-01

A two-equation turbulence model (one equation for turbulence kinetic energy and a second for a generic turbulence length-scale quantity) proposed by Umlauf and Burchard [J. Marine Research 61 (2003) 235] is implemented in a three-dimensional oceanographic model (Regional Oceanographic Modeling System; ROMS v2.0). These two equations, along with several stability functions, can represent many popular turbulence closures, including the k-kl (Mellor-Yamada Level 2.5), k-??, and k-?? schemes. The implementation adds flexibility to the model by providing an unprecedented range of turbulence closure selections in a single 3D oceanographic model and allows comparison and evaluation of turbulence models in an otherwise identical numerical environment. This also allows evaluation of the effect of turbulence models on other processes such as suspended-sediment distribution or ecological processes. Performance of the turbulence models and sediment-transport schemes is investigated with three test cases for (1) steady barotropic flow in a rectangular channel, (2) wind-induced surface mixed-layer deepening in a stratified fluid, and (3) oscillatory stratified pressure-gradient driven flow (estuarine circulation) in a rectangular channel. Results from k-??, k-??, and gen (a new closure proposed by Umlauf and Burchard [J. Marine Research 61 (2003) 235]) are very similar for these cases, but the k-kl closure results depend on a wall-proximity function that must be chosen to suit the flow. Greater variations appear in simulations of suspended-sediment concentrations than in salinity simulations because the transport of suspended-sediment amplifies minor variations in the methods. The amplification is caused by the added physics of a vertical settling rate, bottom stress dependent resuspension, and diffusive transport of sediment in regions of well mixed salt and temperature. Despite the amplified sensitivity of sediment to turbulence models in the estuary test case, the four

40 CFR 721.638 - Silyl amine, potassium salt (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Silyl amine, potassium salt (generic... Substances § 721.638 Silyl amine, potassium salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as silyl amine, potassium salt...

40 CFR 721.638 - Silyl amine, potassium salt (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Silyl amine, potassium salt (generic... Substances § 721.638 Silyl amine, potassium salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as silyl amine, potassium salt...

40 CFR 721.638 - Silyl amine, potassium salt (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Silyl amine, potassium salt (generic... Substances § 721.638 Silyl amine, potassium salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as silyl amine, potassium salt...

40 CFR 721.638 - Silyl amine, potassium salt (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Silyl amine, potassium salt (generic... Substances § 721.638 Silyl amine, potassium salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as silyl amine, potassium salt...

40 CFR 721.638 - Silyl amine, potassium salt (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Silyl amine, potassium salt (generic... Substances § 721.638 Silyl amine, potassium salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as silyl amine, potassium salt...

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

PubMed

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.

Generic Medicine Pricing Policies in Europe: Current Status and Impact

PubMed Central

Dylst, Pieter; Simoens, Steven

2010-01-01

Generic medicine pricing is an area of national responsibility of European Union countries. This article aims to present the current status and impact of generic medicine pricing policies in ambulatory care in Europe. The study conducts a literature review of policies relating to free-pricing systems, price-regulated systems, price differentiation, price competition and discounts, and tendering procedures; and a survey of European generic medicine pricing policies. Competition from Indian generic medicine manufacturers, European variation in generic medicine prices and competition between generic medicine manufacturers by discount suggest that the potential savings to health care payers and patients from generic medicines are not fully realized in Europe. One way of attaining these savings may be to move away from competition by discount to competition by price. Free-pricing systems may drive medicine prices downwards under specific conditions. In price-regulated systems, regulation may lower prices of originator and generic medicines, but may also remove incentives for additional price reductions beyond those imposed by regulation. To date, little is known about the current status and impact of tendering procedures for medicines in ambulatory care. In conclusion, the European experience suggests that there is not a single approach towards developing generic medicine pricing policies in Europe. PMID:27713264

Identifying ELIXIR Core Data Resources

PubMed Central

Durinx, Christine; McEntyre, Jo; Appel, Ron; Apweiler, Rolf; Barlow, Mary; Blomberg, Niklas; Cook, Chuck; Gasteiger, Elisabeth; Kim, Jee-Hyub; Lopez, Rodrigo; Redaschi, Nicole; Stockinger, Heinz; Teixeira, Daniel; Valencia, Alfonso

2017-01-01

The core mission of ELIXIR is to build a stable and sustainable infrastructure for biological information across Europe. At the heart of this are the data resources, tools and services that ELIXIR offers to the life-sciences community, providing stable and sustainable access to biological data. ELIXIR aims to ensure that these resources are available long-term and that the life-cycles of these resources are managed such that they support the scientific needs of the life-sciences, including biological research. ELIXIR Core Data Resources are defined as a set of European data resources that are of fundamental importance to the wider life-science community and the long-term preservation of biological data. They are complete collections of generic value to life-science, are considered an authority in their field with respect to one or more characteristics, and show high levels of scientific quality and service. Thus, ELIXIR Core Data Resources are of wide applicability and usage. This paper describes the structures, governance and processes that support the identification and evaluation of ELIXIR Core Data Resources. It identifies key indicators which reflect the essence of the definition of an ELIXIR Core Data Resource and support the promotion of excellence in resource development and operation. It describes the specific indicators in more detail and explains their application within ELIXIR’s sustainability strategy and science policy actions, and in capacity building, life-cycle management and technical actions. The identification process is currently being implemented and tested for the first time. The findings and outcome will be evaluated by the ELIXIR Scientific Advisory Board in March 2017. Establishing the portfolio of ELIXIR Core Data Resources and ELIXIR Services is a key priority for ELIXIR and publicly marks the transition towards a cohesive infrastructure. PMID:27803796

Identifying ELIXIR Core Data Resources.

PubMed

Durinx, Christine; McEntyre, Jo; Appel, Ron; Apweiler, Rolf; Barlow, Mary; Blomberg, Niklas; Cook, Chuck; Gasteiger, Elisabeth; Kim, Jee-Hyub; Lopez, Rodrigo; Redaschi, Nicole; Stockinger, Heinz; Teixeira, Daniel; Valencia, Alfonso

2016-01-01

The core mission of ELIXIR is to build a stable and sustainable infrastructure for biological information across Europe. At the heart of this are the data resources, tools and services that ELIXIR offers to the life-sciences community, providing stable and sustainable access to biological data. ELIXIR aims to ensure that these resources are available long-term and that the life-cycles of these resources are managed such that they support the scientific needs of the life-sciences, including biological research. ELIXIR Core Data Resources are defined as a set of European data resources that are of fundamental importance to the wider life-science community and the long-term preservation of biological data. They are complete collections of generic value to life-science, are considered an authority in their field with respect to one or more characteristics, and show high levels of scientific quality and service. Thus, ELIXIR Core Data Resources are of wide applicability and usage. This paper describes the structures, governance and processes that support the identification and evaluation of ELIXIR Core Data Resources. It identifies key indicators which reflect the essence of the definition of an ELIXIR Core Data Resource and support the promotion of excellence in resource development and operation. It describes the specific indicators in more detail and explains their application within ELIXIR's sustainability strategy and science policy actions, and in capacity building, life-cycle management and technical actions. The identification process is currently being implemented and tested for the first time. The findings and outcome will be evaluated by the ELIXIR Scientific Advisory Board in March 2017. Establishing the portfolio of ELIXIR Core Data Resources and ELIXIR Services is a key priority for ELIXIR and publicly marks the transition towards a cohesive infrastructure.

40 CFR 721.6498 - Modified polyisocyanates (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... SUBSTANCES CONTROL ACT SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES Significant New Uses for Specific Chemical Substances § 721.6498 Modified polyisocyanates (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified polyisocyanates (PMN P...

40 CFR 721.6498 - Modified polyisocyanates (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... SUBSTANCES CONTROL ACT SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES Significant New Uses for Specific Chemical Substances § 721.6498 Modified polyisocyanates (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified polyisocyanates (PMN P...

40 CFR 721.6498 - Modified polyisocyanates (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... SUBSTANCES CONTROL ACT SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES Significant New Uses for Specific Chemical Substances § 721.6498 Modified polyisocyanates (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified polyisocyanates (PMN P...

Money left on the table: generic drug prices in Canada.

PubMed

Law, Michael R

2013-02-01

Generic drugs are a major cost-saving opportunity for patients and drug plans. While almost every province has reduced generic drug prices, we have no information on whether these new prices are internationally competitive. Therefore, I compared Canadian prices to those in two other countries. I used 2009 data from the IMS Brogan Canadian CompuScript and PharmaStat databases and studied the 100 most frequently dispensed generic products in Ontario, which has Canada's lowest generic prices. I compared these prices to those in public drug programs in the United States and New Zealand that use tendering. Using these alternative prices, I calculated the potential savings in Ontario. Of the top 100 generic products, 82 were listed on an international formulary. In 90% of cases, generic products were less expensive in other countries. If Ontario had obtained the lowest comparator price for these products, the annual public sector and overall drug expenditure savings would have been $129 million and $245 million, respectively. Further, the province could have publicly paid for all these generic drugs - both public and private - and saved $87 million compared to current public sector expenditures. Even after recent reforms, generic drug prices in Canada remain high by international standards. I found that if Ontario had obtained commonly used generic drugs at international best prices, the province could have publicly paid for all generic drugs and lowered annual expenditures by nearly a quarter-billion dollars. Copyright © 2013 Longwoods Publishing.

Money Left on the Table: Generic Drug Prices in Canada

PubMed Central

Law, Michael R.

2013-01-01

Background: Generic drugs are a major cost-saving opportunity for patients and drug plans. While almost every province has reduced generic drug prices, we have no information on whether these new prices are internationally competitive. Therefore, I compared Canadian prices to those in two other countries. Methods: I used 2009 data from the IMS Brogan Canadian CompuScript and PharmaStat databases and studied the 100 most frequently dispensed generic products in Ontario, which has Canada's lowest generic prices. I compared these prices to those in public drug programs in the United States and New Zealand that use tendering. Using these alternative prices, I calculated the potential savings in Ontario. Results: Of the top 100 generic products, 82 were listed on an international formulary. In 90% of cases, generic products were less expensive in other countries. If Ontario had obtained the lowest comparator price for these products, the annual public sector and overall drug expenditure savings would have been $129 million and $245 million, respectively. Further, the province could have publicly paid for all these generic drugs – both public and private – and saved $87 million compared to current public sector expenditures. Discussion: Even after recent reforms, generic drug prices in Canada remain high by international standards. I found that if Ontario had obtained commonly used generic drugs at international best prices, the province could have publicly paid for all generic drugs and lowered annual expenditures by nearly a quarter-billion dollars. PMID:23968624

40 CFR 721.10677 - Alkyl phosphonate (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... CONTROL ACT SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES Significant New Uses for Specific Chemical Substances § 721.10677 Alkyl phosphonate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl phosphonate (PMN P-12-584...

APEX/SABOCA observations of small-scale structure of infrared-dark clouds . I. Early evolutionary stages of star-forming cores

NASA Astrophysics Data System (ADS)

Ragan, Sarah E.; Henning, Thomas; Beuther, Henrik

2013-11-01

Infrared-dark clouds (IRDCs) harbor the early phases of cluster and high-mass star formation and are comprised of cold (~20 K), dense (n > 104 cm-3) gas. The spectral energy distribution (SED) of IRDCs is dominated by the far-infrared and millimeter wavelength regime, and our initial Herschel study examined IRDCs at the peak of the SED with high angular resolution. Here we present a follow-up study using the SABOCA instrument on APEX which delivers 7.8″ angular resolution at 350 μm, matching the resolution we achieved with Herschel/PACS, and allowing us to characterize substructure on ~0.1 pc scales. Our sample of 11 nearby IRDCs are a mix of filamentary and clumpy morphologies, and the filamentary clouds show significant hierarchical structure, while the clumpy IRDCs exhibit little hierarchical structure. All IRDCs, regardless of morphology, have about 14% of their total mass in small scale core-like structures which roughly follow a trend of constant volume density over all size scales. Out of the 89 protostellar cores we identified in this sample with Herschel, we recover 40 of the brightest and re-fit their SEDs and find their properties agree fairly well with our previous estimates (⟨ T ⟩ ~ 19 K). We detect a new population of "cold cores" which have no 70 μm counterpart, but are 100 and 160 μm-bright, with colder temperatures (⟨ T ⟩ ~ 16 K). This latter population, along with SABOCA-only detections, are predominantly low-mass objects, but their evolutionary diagnostics are consistent with the earliest starless or prestellar phase of cores in IRDCs. Based on observations carried out with the Atacama Pathfinder Experiment (APEX). APEX is a collaboration between Max Planck Institut für Radioastronomie (MPIfR), Onsala Space Observatory (OSO), and the European Southern Observatory (ESO).Appendices are available in electronic form at http://www.aanda.org

40 CFR 721.10262 - Oxime, Me vinyl silane (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Oxime, Me vinyl silane (generic). 721... Substances § 721.10262 Oxime, Me vinyl silane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as oxime, Me vinyl silane (PMN P...

40 CFR 721.10262 - Oxime, Me vinyl silane (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Oxime, Me vinyl silane (generic). 721... Substances § 721.10262 Oxime, Me vinyl silane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as oxime, Me vinyl silane (PMN P...

40 CFR 721.9970 - o-Xylene compound (generic name).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false o-Xylene compound (generic name). 721... Substances § 721.9970 o-Xylene compound (generic name). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as an o-xylene compound (PMN P-95...

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).

PubMed

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.

Measuring the impact of cataract surgery on generic and vision-specific quality of life.

PubMed

Groessl, Erik J; Liu, Lin; Sklar, Marisa; Tally, Steven R; Kaplan, Robert M; Ganiats, Theodore G

2013-08-01

Cataracts are the leading cause of blindness worldwide and cause visual impairment for millions of adults in the United States. We compared the sensitivity of a vision-specific health-related quality of life (HRQOL) measure to that of multiple generic measures of HRQOL before and at 2 time points after cataract surgery. Participants completed 1 vision-specific and 5 generic quality of life measures before cataract surgery, and again 1 and 6 months after surgery. Random effects modeling was used to measure changes over the three assessment points. The NEI-VFQ25 total score and all 11 subscales showed significant improvements during the first interval (baseline and 1 month). During the second interval (1-6 months post-surgery), significant improvements were observed on the total score and 5 of 11 NEI-VFQ25 subscales. There were significant increases in HRQOL during the first interval on some preference-based generic HRQOL measures, though changes during the second interval were mostly non-significant. None of the SF-36v2™ or SF6D scales changed significantly between any of the assessment periods. The NEI-VFQ25 was sensitive to changes in vision-specific domains of QOL. Some preference-based generic HRQOL measures were also sensitive to change and showed convergence with the NEI-VFQ25, but the effects were small. The SF-36v2™ and SF-6D did not change in a similar manner, possibly reflecting a lack of vision-related content. Studies seeking to document both the vision-specific and generic HRQOL improvements of cataract surgery should consider these results when selecting measures.

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

PubMed

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.

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

PubMed

King, Derek R; Kanavos, Panos

2002-08-01

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

The development and validation of the core competencies scale (CCS) for the college and university students.

PubMed

Ruan, Bin; Mok, Magdalena Mo Ching; Edginton, Christopher R; Chin, Ming Kai

2012-01-01

This article describes the development and validation of the Core Competencies Scale (CCS) using Bok's (2006) competency framework for undergraduate education. The framework included: communication, critical thinking, character development, citizenship, diversity, global understanding, widening of interest, and career and vocational development. The sample comprised 70 college and university students. Results of analysis using Rasch rating scale modelling showed that there was strong empirical evidence on the validity of the measures in contents, structure, interpretation, generalizability, and response options of the CCS scale. The implication of having developed Rasch-based valid and dependable measures in this study for gauging the value added of college and university education to their students is that the feedback generated from CCS will enable evidence-based decision and policy making to be implemented and strategized. Further, program effectiveness can be measured and thus accountability on the achievement of the program objectives.

Assessment of knowledge and perceptions toward generic medicines among basic science undergraduate medical students at Aruba.

PubMed

Shankar, P Ravi; Herz, Burton L; Dubey, Arun K; Hassali, Mohamed A

2016-10-01

Use of generic medicines is important to reduce rising health-care costs. Proper knowledge and perception of medical students and doctors toward generic medicines are important. Xavier University School of Medicine in Aruba admits students from the United States, Canada, and other countries to the undergraduate medical (MD) program. The present study was conducted to study the knowledge and perception about generic medicines among basic science MD students. The cross-sectional study was conducted among first to fifth semester students during February 2015. A previously developed instrument was used. Basic demographic information was collected. Respondent's agreement with a set of statements was noted using a Likert-type scale. The calculated total score was compared among subgroups of respondents. One sample Kolmogorov-Smirnov test was used to study the normality of distribution, Independent samples t -test to compare the total score for dichotomous variables, and analysis of variance for others were used for statistical analysis. Fifty-six of the 85 students (65.8%) participated. Around 55% of respondents were between 20 and 25 years of age and of American nationality. Only three respondents (5.3%) provided the correct value of the regulatory bioequivalence limits. The mean total score was 43.41 (maximum 60). There was no significant difference in scores among subgroups. There was a significant knowledge gap with regard to the regulatory bioequivalence limits for generic medicines. Respondents' level of knowledge about other aspects of generic medicines was good but could be improved. Studies among clinical students in the institution and in other Caribbean medical schools are required. Deficiencies were noted and we have strengthened learning about generic medicines during the basic science years.

40 CFR 721.10246 - Alkylpolyhydroxy polymer (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Alkylpolyhydroxy polymer (generic... Specific Chemical Substances § 721.10246 Alkylpolyhydroxy polymer (generic). (a) Chemical substance and... alkylpolyhydroxy polymer (PMN P-09-234) is subject to reporting under this section for the significant new uses...

40 CFR 721.10246 - Alkylpolyhydroxy polymer (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Alkylpolyhydroxy polymer (generic... Specific Chemical Substances § 721.10246 Alkylpolyhydroxy polymer (generic). (a) Chemical substance and... alkylpolyhydroxy polymer (PMN P-09-234) is subject to reporting under this section for the significant new uses...

40 CFR 721.10246 - Alkylpolyhydroxy polymer (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Alkylpolyhydroxy polymer (generic... Specific Chemical Substances § 721.10246 Alkylpolyhydroxy polymer (generic). (a) Chemical substance and... alkylpolyhydroxy polymer (PMN P-09-234) is subject to reporting under this section for the significant new uses...

Generic Skills in Vocational Education and Training: Research Readings

ERIC Educational Resources Information Center

Gibb, Jennifer, Ed.

2004-01-01

Possessing generic or employability skills is vital in the current labour market. The vocational education and training (VET) sector, like other education sectors, must ensure its clients gain and develop generic skills. This volume of readings summarises NCVER managed research into generic skills undertaken in 2001 and 2002. The work covers four…

40 CFR 721.10261 - Oxime, di-Me silane (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Oxime, di-Me silane (generic). 721... Substances § 721.10261 Oxime, di-Me silane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as oxime, di-Me silane (PMN P-09-589...

40 CFR 721.10261 - Oxime, di-Me silane (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Oxime, di-Me silane (generic). 721... Substances § 721.10261 Oxime, di-Me silane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as oxime, di-Me silane (PMN P-09-589...

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

PubMed

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.

On assessing bioequivalence and interchangeability between generics based on indirect comparisons.

PubMed

Zheng, Jiayin; Chow, Shein-Chung; Yuan, Mengdie

2017-08-30

As more and more generics become available in the market place, the safety/efficacy concerns may arise as the result of interchangeably use of approved generics. However, bioequivalence assessment for regulatory approval among generics of the innovative drug product is not required. In practice, approved generics are often used interchangeably without any mechanism of safety monitoring. In this article, based on indirect comparisons, we proposed several methods to assessing bioequivalence and interchangeability between generics. The applicability of the methods and the similarity assumptions were discussed, as well as the inappropriateness of directly adopting adjusted indirect comparison to the field of generics' comparison. Besides, some extensions were given to take into consideration the important topics in clinical trials for bioequivalence assessments, for example, multiple comparisons and simultaneously testing bioequivalence among three generics. Extensive simulation studies were conducted to investigate the performances of the proposed methods. The studies of malaria generics and HIV/AIDS generics prequalified by the WHO were used as real examples to demonstrate the use of the methods. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Generic drugs: international trends and policy developments in Australia.

PubMed

Lofgren, Hans

2004-01-01

Public and private third-party payers in many countries encourage or mandate the use of generic drugs. This article examines the development of generics policy in Australia, against the background of a description of international trends in this area, and related experiences of reference pricing programs. The Australian generics market remains underdeveloped due to a historical legacy of small Pharmaceutical Benefits Scheme price differentials between originator brands and generics. It is argued that policy measures open to the Australian government can be conceived as clustering around two different approaches: incremental changes within the existing regulatory framework, or a shift towards a high volume/low price role of generics which would speed up the delivery of substantial cost savings, and could provide enhanced scope for the financing of new, patented drugs.

Genericization: A Theory of Semantic Broadening in the Marketplace.

ERIC Educational Resources Information Center

Clankie, Shawn M.

2000-01-01

Genericization theory developed as a response to claims from outside of linguistics that generic use in brand names (for example, using Kleenex as a generic noun for all facial tissues, or Xerox for all photocopiers) is the result of marketing factors or misuse by consumers. This paper examines the linguistic factors that create an environment…

Generic Quarantine Radiation Treatment; The Next Steps

USDA-ARS?s Scientific Manuscript database

In 2006, USDA-APHIS published a landmark rule providing generic radiation quarantine treatments. The rule approved irradiation doses of 150 Gy for any tephritid fruit fly and 400 Gy for all other insects except the pupa and adult stages of Lepidoptera. The generic radiation treatments apply to all f...

The Short-Term Impact of Ontario's Generic Pricing Reforms

PubMed Central

Law, Michael R.; Ystma, Alison; Morgan, Steven G.

2011-01-01

Background Canadians pay amongst the highest generic drug prices in the world. In July 2010, the province of Ontario enacted a policy that halved reimbursement for generic drugs from the public drug plan, and substantially lowered prices for private purchases. We quantified the impact of this policy on overall generic drug expenditures in the province, and projected the impact in other provinces had they mimicked this pricing change. Methods We used quarterly prescription generic drug dispensing data from the IMS-Brogan CompuScript Audit. We used the price per unit in both the pre- and post-policy period and two economics price indexes to estimate the expenditure reduction in Ontario. Further, we used the post-policy Ontario prices to estimate the potential reduction in other provinces. Results We estimate that total expenditure on generic drugs in Ontario during the second half of 2010 was between $181 and $194 million below what would be expected if prices had remained at pre-policy level. Over half of the reduction in spending was due to savings on just 10 generic ingredients. If other provinces had matched Ontario's prices, their expenditures over during the latter half of 2010 would have been $445 million lower. Discussion We found that if Ontario's pricing scheme were adopted nationally, overall spending on generic drugs in Canada would drop at least $1.28 billion annually—a 5% decrease in total prescription drug expenditure. Other provinces should seriously consider both changes to their generic drug prices and the use of more competitive bulk purchasing policies. PMID:21829581

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

PubMed

Law, Michael R; Ystma, Alison; Morgan, Steven G

2011-01-01

Canadians pay amongst the highest generic drug prices in the world. In July 2010, the province of Ontario enacted a policy that halved reimbursement for generic drugs from the public drug plan, and substantially lowered prices for private purchases. We quantified the impact of this policy on overall generic drug expenditures in the province, and projected the impact in other provinces had they mimicked this pricing change. We used quarterly prescription generic drug dispensing data from the IMS-Brogan CompuScript Audit. We used the price per unit in both the pre- and post-policy period and two economics price indexes to estimate the expenditure reduction in Ontario. Further, we used the post-policy Ontario prices to estimate the potential reduction in other provinces. We estimate that total expenditure on generic drugs in Ontario during the second half of 2010 was between $181 and $194 million below what would be expected if prices had remained at pre-policy level. Over half of the reduction in spending was due to savings on just 10 generic ingredients. If other provinces had matched Ontario's prices, their expenditures over during the latter half of 2010 would have been $445 million lower. We found that if Ontario's pricing scheme were adopted nationally, overall spending on generic drugs in Canada would drop at least $1.28 billion annually--a 5% decrease in total prescription drug expenditure. Other provinces should seriously consider both changes to their generic drug prices and the use of more competitive bulk purchasing policies.

Generic Entry, Reformulations, and Promotion of SSRIs

PubMed Central

Donohue, Julie M.; Koss, Catherine; Berndt, Ernst R.; Frank, Richard G.

2009-01-01

Background Previous research has shown that a manufacturer’s promotional strategy for a brand-name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion. Objective To examine the relationship between promotional expenditures, generic entry, reformulation entry, and new indication approval. Study Design/Setting We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising (DTCA), and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997 through 2004. We estimated econometric models of detailing, DTCA, and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations, and Food and Drug Administration (FDA) approval for new clinical indications for existing medications in the SSRI class. Main Outcome Measure Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications. Results Over the period 1997–2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays

Assessing bioequivalence of generic modified-release antiepileptic drugs

PubMed Central

Chang, Yi-Ting; Davit, Barbara; Gidal, Barry E.; Krauss, Gregory L.

2016-01-01

Objectives: The purpose of this study was to determine how closely generic modified-release antiepileptic drugs (MR-AEDs) resemble reference (brand) formulations by comparing peak concentrations (Cmax), total absorption (area under the curve [AUC]), time to Cmax (Tmax), intersubject variability, and food effects between generic and reference products. Methods: We tabulated Cmax and AUC data from the bioequivalence (BE) studies used to support the approvals of generic Food and Drug Administration–approved MR-AEDs. We compared differences in 90% confidence intervals of the generic/reference AUC and Cmax geometric mean ratios, and intersubject variability, Tmax and delivery profiles and food effects. Results: Forty-two MR-AED formulations were studied in 3,175 healthy participants without epilepsy in 97 BE studies. BE ratios for AUC and Cmax were similar between most generic and reference products: AUC ratios varied by >15% in 11.4% of BE studies; Cmax varied by >15% in 25.8% of studies. Tmax was more variable, with >30% difference in 13 studies (usually delayed in the fed compared to fasting BE studies). Generic and reference MR products had similar intersubject variability. Immediate-release AEDs showed less intersubject variability in AUC than did MR-AEDs. Conclusions: Most generic and reference MR-AEDs have similar AUC and Cmax values. Ratios for some products, however, are near acceptance limits and Tmax values may vary. Food effects are common with MR-AED products. High variability in pharmacokinetic values for once-a-day MR-AEDs suggests their major advantage compared to immediate-release AED formulations may be the convenience of less frequent dosing to improve adherence. PMID:27016518

17 CFR 230.135a - Generic advertising.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 17 Commodity and Securities Exchanges 2 2012-04-01 2012-04-01 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...

17 CFR 230.135a - Generic advertising.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 17 Commodity and Securities Exchanges 2 2013-04-01 2013-04-01 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...

17 CFR 230.135a - Generic advertising.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 17 Commodity and Securities Exchanges 2 2011-04-01 2011-04-01 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...

17 CFR 230.135a - Generic advertising.

Code of Federal Regulations, 2010 CFR

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...

17 CFR 230.135a - Generic advertising.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 17 Commodity and Securities Exchanges 3 2014-04-01 2014-04-01 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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

Testing the dynamic coupling of the core-mantle and inner core boundaries

NASA Astrophysics Data System (ADS)

Driscoll, Peter E.

2015-07-01

The proposal that the seismically observed hemispherical asymmetry of Earth's inner core is controlled by the heat flux structure imposed on the outer core by the lower mantle is tested with numerical dynamo models driven by mixed thermochemical convection. We find that models driven by a single core-mantle boundary (CMB) spherical harmonic of degree and mode 2, the dominant mode in lower mantle seismic shear velocity tomography, produce a similar structure at the inner core boundary (ICB) shifted 30∘ westward. The sensitivity of the ICB to the CMB is further tested by increasing the CMB heterogeneity amplitude. In addition, two seismic tomographic models are tested: first with CMB resolution up to degree and order 4, and second with resolution up to degree and order 8. We find time-averaged ICB heat flux in these cases to be similar at large scale, with small-scale differences due to higher CMB harmonics (above degree 4). The tomographic models produce "Earth-like" magnetic fields, while similar models with twice the CMB heat flow amplitudes produce less Earth-like fields, implying that increasing CMB heterogeneity forces the model out of an Earth-like regime. The dynamic ICB heat fluxes are compared to the proposed translation mode of the inner core to test whether the CMB controls inner core growth and structure. This test indicates that, although CMB tomography is unlikely to be driving inner core translation, the ICB heat flux response is weak enough to not interfere with the most unstable translation mode, if it is occurring.

Generic substitution: micro evidence from register data in Norway.

PubMed

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.

State generic substitution laws can lower drug outlays under medicaid

PubMed Central

Choudhry, Niteesh K.; Agnew-Blais, Jessica; Federman, Alex D.; Liberman, Joshua N.; Liu, Jun; Kesselheim, Aaron S.; Brookhart, M. Alan; Fischer, Michael A.

2011-01-01

To stem the rising costs of medications, states have implemented varying generic substitution policies. These policies differ in the extent to which pharmacists or patients can influence medication choice. Using national Medicaid data, we evaluated the relationship between different generic substitution policies and generic simvastatin use after patent expiration of branded Zocor. States implementing policies that require patient consent prior to generic substitution experienced 25% lower rates of generic substitution. By eliminating patient consent requirements, state Medicaid programs could expect to save over $100 million dollars in coverage for 3 top-selling medications nearing patent expiration. The implications of these regulations on national medication spending should be considered. PMID:20606192

Industry Application ECCS / LOCA Integrated Cladding/Emergency Core Cooling System Performance: Demonstration of LOTUS-Baseline Coupled Analysis of the South Texas Plant Model

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

Zhang, Hongbin; Szilard, Ronaldo; Epiney, Aaron

Under the auspices of the DOE LWRS Program RISMC Industry Application ECCS/LOCA, INL has engaged staff from both South Texas Project (STP) and the Texas A&M University (TAMU) to produce a generic pressurized water reactor (PWR) model including reactor core, clad/fuel design and systems thermal hydraulics based on the South Texas Project (STP) nuclear power plant, a 4-Loop Westinghouse PWR. A RISMC toolkit, named LOCA Toolkit for the U.S. (LOTUS), has been developed for use in this generic PWR plant model to assess safety margins for the proposed NRC 10 CFR 50.46c rule, Emergency Core Cooling System (ECCS) performance duringmore » LOCA. This demonstration includes coupled analysis of core design, fuel design, thermalhydraulics and systems analysis, using advanced risk analysis tools and methods to investigate a wide range of results. Within this context, a multi-physics best estimate plus uncertainty (MPBEPU) methodology framework is proposed.« less

Generic drug policy in Australia: a community pharmacy perspective

PubMed Central

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

Study of generic quality of life in patients operated on for post-prostatectomy incontinence.

PubMed

Holm, Henriette Veiby; Fosså, Sophie D; Hedlund, Hans; Dahl, Alv A

2013-09-01

The relationship between urological and psychosocial variables, and generic quality of life in patients operated on for post-prostatectomy incontinence has hardly been studied, and our aim was to investigate this relationship. Patients who had an artificial urinary sphincter AMS800 (n = 100) implanted between January 2002 and June 2010 were invited to complete a mailed questionnaire covering demographic data including work ability, urinary and sexual function, anxiety/depression, and generic quality of life. Poor quality of life was defined as a score <40 on either the physical or the mental Short Form 12 summary scales. Of 85 compliant patients, 30 (35%) reported poor generic quality of life and 55 (65%) reported better quality of life at a median follow-up time of 26 months (range 6-104 months). The poor quality of life group showed significantly more overall urinary and sexual problems, and more men had undergone surgical revisions compared with the better quality of life group. Levels of anxiety and depression were significantly higher, and work ability was lower in the poor quality of life group. In multivariate logistic regression models, increased level of depression and impaired work ability, inability to reach orgasm, and not recommending the operation remained significantly associated with poor quality of life. Poor generic quality of life after surgery for post-prostatectomy incontinence is more strongly associated with reduced work ability and depression rather than urinary and sexual problems. © 2013 The Japanese Urological Association.

Impact of medicare part D plan features on use of generic drugs.

PubMed

Tang, Yan; Gellad, Walid F; Men, Aiju; Donohue, Julie M

2014-06-01

Little is known about how Medicare Part D plan features influence choice of generic versus brand drugs. To examine the association between Part D plan features and generic medication use. Data from a 2009 random sample of 1.6 million fee-for-service, Part D enrollees aged 65 years and above, who were not dually eligible or receiving low-income subsidies, were used to examine the association between plan features (generic cost-sharing, difference in brand and generic copay, prior authorization, step therapy) and choice of generic antidepressants, antidiabetics, and statins. Logistic regression models accounting for plan-level clustering were adjusted for sociodemographic and health status. Generic cost-sharing ranged from $0 to $9 for antidepressants and statins, and from $0 to $8 for antidiabetics (across 5th-95th percentiles). Brand-generic cost-sharing differences were smallest for statins (5th-95th percentiles: $16-$37) and largest for antidepressants ($16-$64) across plans. Beneficiaries with higher generic cost-sharing had lower generic use [adjusted odds ratio (OR)=0.97, 95% confidence interval (CI), 0.95-0.98 for antidepressants; OR=0.97, 95% CI, 0.96-0.98 for antidiabetics; OR=0.94, 95% CI, 0.92-0.95 for statins]. Larger brand-generic cost-sharing differences and prior authorization were significantly associated with greater generic use in all categories. Plans could increase generic use by 5-12 percentage points by reducing generic cost-sharing from the 75th ($7) to 25th percentiles ($4-$5), increasing brand-generic cost-sharing differences from the 25th ($25-$26) to 75th ($32-$33) percentiles, and using prior authorization and step therapy. Cost-sharing features and utilization management tools were significantly associated with generic use in 3 commonly used medication categories.

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

PubMed

Puig-Junoy, Jaume

2012-11-01

In many countries with generic reference pricing, generic producers and distributors compete by means of undisclosed discounts offered to pharmacies in order to reduce acquisition costs and to induce them to dispense their generic to patients in preference over others. The objective of this article is to test the hypothesis that under prevailing reference pricing systems for generic medicines, those medicines sold at a higher consumer price may enjoy a competitive advantage. Real transaction prices for 179 generic medicines acquired by pharmacies in Spain have been used to calculate the discount rate on acquisition versus reimbursed costs to pharmacies. Two empirical hypotheses are tested: the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical presentations for which there are more generic competitors; and, the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical forms for which the consumer price has declined less in relation to the consumer price of the brand drug before generic entry (higher-priced generic medicines). An average discount rate of 39.3% on acquisition versus reimbursed costs to pharmacies has been observed. The magnitude of the discount positively depends on the number of competitors in the market. The higher the ratio of the consumer price of the generic to that of the brand drug prior to generic entry (i.e. the smaller the price reduction of the generic in relation to the brand drug), the larger the discount rate. Under reference pricing there is intense price competition among generic firms in the form of unusually high discounts to pharmacies on official ex-factory prices reimbursed to pharmacies. However, this effect is highly distorting because it favours those medicines with a higher relative price in relation to the brand price before generic entry.

40 CFR 721.10298 - MDI terminated polyester polyurethane polymer (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... polymer (generic). 721.10298 Section 721.10298 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10298 MDI terminated polyester polyurethane polymer (generic). (a... generically as MDI terminated polyester polyurethane polymer (P-11-662) is subject to reporting under this...

40 CFR 721.10298 - MDI terminated polyester polyurethane polymer (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... polymer (generic). 721.10298 Section 721.10298 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10298 MDI terminated polyester polyurethane polymer (generic). (a... generically as MDI terminated polyester polyurethane polymer (P-11-662) is subject to reporting under this...

40 CFR 721.10298 - MDI terminated polyester polyurethane polymer (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... polymer (generic). 721.10298 Section 721.10298 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10298 MDI terminated polyester polyurethane polymer (generic). (a... generically as MDI terminated polyester polyurethane polymer (P-11-662) is subject to reporting under this...

Generic substitution of antihypertensive drugs: does it affect adherence?

PubMed

Van Wijk, Boris L G; Klungel, Olaf H; Heerdink, Eibert R; de Boer, Anthonius

2006-01-01

Generic substitution is an important opportunity to reduce the costs of pharmaceutical care. However, pharmacists and physicians often find that patients and brand-name manufacturers have doubt about the equivalence of the substituted drug. This may be reflected by decreased adherence to therapy. To assess the association between generic substitution and nonadherence to antihypertensive drugs. We conducted a matched cohort study between January 1, 1999, and December 31, 2002. Data were obtained from PHARMO, a record linkage system containing drug-dispensing records from community pharmacies and linked hospital discharge records of approximately 950,000 people in The Netherlands. Residents of 30 medium-sized cities who initiated antihypertensive drug therapy were potential subjects. Refill adherence with antihypertensive drugs after substitution was determined; those with refill adherence below 80% were considered nonadherent. Four hundred sixty-three patients with a substitution in therapy and 565 controls, matched on age, gender, therapy start date, duration of use, and generic product code, were identified. Of the patients who switched from brand-name to generic formulations ("substituted"), 13.6% were nonadherent, and of the non-substituted patients (those who did not switch to generic), 18.7% were nonadherent (OR 0.68; 95% CI 0.48 to 0.96). The association was absent in males. None of the patients discontinued the medication. No differences in hospitalizations for cardiovascular disease in the 6 months after the substitution were observed. Generic substitution of antihypertensive drugs does not lead to lower adherence or more discontinuation and cardiovascular disease-related hospitalizations compared with brand-name therapy. When a less-expensive antihypertensive generic equivalent becomes available, generic substitution should be considered to achieve economic benefits.

Comparative effectiveness of generic versus brand-name antiepileptic medications.

PubMed

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.

Three Types of Earth's Inner Core Boundary

NASA Astrophysics Data System (ADS)

Tian, D.; Wen, L.

2017-12-01

The Earth's inner core boundary (ICB) is the site where the liquid outer core solidifies and the solid inner core grows. Thus, the fine-scale structure of the ICB is important for our understanding of the thermo-compositional state of the Earth's core. In this study, we collect a large set of seismic records with high-quality pre-critical PKiKP and PcP phase pairs, recorded by two dense seismic arrays, Hi-net in Japan and USArray in US. This dataset samples the ICB regions beneath East Asia, Mexico and the Bering Sea. We use differential travel times, amplitude ratios and waveform differences between PKiKP and PcP phases to constrain fine-scale structure of the ICB. The sampled ICB can be grouped into three types based on their seismic characteristics: (1) a simple ICB with a flat and sharp boundary, (2) a bumpy ICB with topographic height changes of 10 km, and (3) a localized mushy ICB with laterally varying thicknesses of 4-8 km. The laterally varying fine-scale structure of the ICB indicates existence of complex small-scale forces at the surface and a laterally varying solidification process of the inner core due to lateral variation of thermo-compositional condition near the ICB.

Rheumatology training experience across Europe: analysis of core competences.

PubMed

Sivera, Francisca; Ramiro, Sofia; Cikes, Nada; Cutolo, Maurizio; Dougados, Maxime; Gossec, Laure; Kvien, Tore K; Lundberg, Ingrid E; Mandl, Peter; Moorthy, Arumugam; Panchal, Sonia; da Silva, José A P; Bijlsma, Johannes W

2016-09-23

The aim of this project was to analyze and compare the educational experience in rheumatology specialty training programs across European countries, with a focus on self-reported ability. An electronic survey was designed to assess the training experience in terms of self-reported ability, existence of formal education, number of patients managed and assessments performed during rheumatology training in 21 core competences including managing specific diseases, generic competences and procedures. The target population consisted of rheumatology trainees and recently certified rheumatologists across Europe. The relationship between the country of training and the self-reported ability or training methods for each competence was analyzed through linear or logistic regression, as appropriate. In total 1079 questionnaires from 41 countries were gathered. Self-reported ability was high for most competences, range 7.5-9.4 (0-10 scale) for clinical competences, 5.8-9.0 for technical procedures and 7.8-8.9 for generic competences. Competences with lower self-reported ability included managing patients with vasculitis, identifying crystals and performing an ultrasound. Between 53 and 91 % of the trainees received formal education and between 7 and 61 % of the trainees reported limited practical experience (managing ≤10 patients) in each competence. Evaluation of each competence was reported by 29-60 % of the respondents. In adjusted multivariable analysis, the country of training was associated with significant differences in self-reported ability for all individual competences. Even though self-reported ability is generally high, there are significant differences amongst European countries, including differences in the learning structure and assessment of competences. This suggests that educational outcomes may also differ. Efforts to promote European harmonization in rheumatology training should be encouraged and supported.

Questionnaire on the awareness of generic drugs among outpatients and medical staff.

PubMed

Hoshi, S; Kimura, H

2008-06-01

Generic drugs are not as widely used in Japan as they are in the West. The objective of this study was to survey the awareness of generic drugs among outpatients and medical staff and propose methods of promoting the use of generic drugs. Our survey showed that 86.7% of respondents were aware of generic drugs. This is a higher awareness rate than that in a survey of other groups conducted last year. One reason to explain this higher awareness is the recent increase in generic drug advertisements both in newspapers and on television. However, a point of note is that generic drug usage has not increased. Our survey also showed that generic drug awareness was differed widely among age groups, as younger respondents were much more aware of generic drugs than older respondents. Still, about 40% of respondents who were aware of generic drugs did not realize that they were less expensive than name-brand drugs ? including 30% of medical staff. In addition to continuing advertisement of generic drugs in the media, medical doctors and pharmacists should also be encouraged to endorse the use of generic drugs. Furthermore a new system allowing for substitution prescriptions started in April 2008 and consequently pharmacists can now play an important role in promoting the use of generic drugs.

How Abbott’s Fenofibrate Franchise Avoided Generic Competition

PubMed Central

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

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

PubMed

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

2013-01-01

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

[Analysis of generic drug supply in France].

PubMed

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.

40 CFR 721.2060 - Disubstituted benzenedicarboxylic acid (generic).