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Sample records for bioequivalence recommendations active

  1. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability

    Science.gov (United States)

    2012-11-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0433; (formerly Docket No. 2007D-0169)] Draft Guidance for Industry on Bioequivalence Recommendation for...) Acceptable fasting and fed bioequivalence studies on the 25 mg strength, (2) proportional similarity of the...

  2. 77 FR 10535 - Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations...

    Science.gov (United States)

    2012-02-22

    ... recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug... the process that would be used to make product-specific BE recommendations available to the public on... ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make...

  3. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Science.gov (United States)

    2013-11-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability AGENCY... guidance, FDA recommended an in vivo fasting BE study with pharmacokinetic endpoints and in vitro studies...

  4. 75 FR 33311 - Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

    Science.gov (United States)

    2010-06-11

    ... available recommendations on how to design product-specific BE studies to support ANDAs. Under this process... thinking on a new process for making available to sponsors FDA guidance on how to design product-specific... ``Bioequivalence Recommendations for Specific Products.'' This guidance describes a new process for making...

  5. Bioequivalence of eslicarbazepine acetate from two different sources of its active product ingredient in healthy subjects.

    Science.gov (United States)

    Falcão, Amílcar; Lima, Ricardo; Sousa, Rui; Nunes, Teresa; Soares-da-Silva, Patrício

    2013-06-01

    To compare the bioavailability (BA) and pharmacokinetic (PK) properties and to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL) in healthy volunteers. Forty healthy male and female subjects aged 18-40 years were randomized to treatment with 400 or 800 mg ESL marketed (MF) formulation [current active pharmaceutical ingredient (API) source] and 400 or 800 mg ESL to-be-marketed (TBM) formulation (new API source) under a gender-balanced, two-period, two-sequence crossover open-label study design. Subjects were assigned to receive either 400 or 800 mg ESL dose strengths, and each was randomly administered on two occasions--either a single oral tablet of MF or a single oral tablet of TBM--separated by a washout period of at least 7 days. Formulations were to be considered bioequivalent if, for both 400 or 800 mg ESL dosage strengths, the test (TBM)/reference (MF) geometric mean ratios (GMR) and 90% confidence intervals (90% CI) of the area under the plasma concentration-time curve (AUC) and peak plasma concentration (Cmax) were within the predetermined range of 80-125%. Test/reference GMR (90% CI) for the Cmax and AUC was respectively 100% (94-109%) and 96% (94-98%) following 400 mg ESL and 100% (95-105%) and 100% (97-103%) following 800 mg ESL. Oral tablet formulations of either 400 or 800 mg ESL from the new API source were found to be bioequivalent to the corresponding marketed Zebinix® formulation according to the regulatory definition of bioequivalence.

  6. Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

    International Nuclear Information System (INIS)

    Szebeni, Janos; Storm, Gert

    2015-01-01

    Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs. long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.

  7. Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

    Energy Technology Data Exchange (ETDEWEB)

    Szebeni, Janos, E-mail: jszebeni2@gmail.com [Nanomedicine Research and Education Center, Semmelweis University, Budapest & SeroScience Ltd, Budapest (Hungary); Storm, Gert [Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht (Netherlands)

    2015-12-18

    Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs. long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.

  8. Bioequivalence of azathioprine products.

    Science.gov (United States)

    Baker, Daniel E

    2003-01-01

    All azathioprine oral tablets are considered bioequivalent by the Food and Drug Administration based on traditional testing. However, since these tests were conducted, it has been determined that some patients have a deficiency of the enzyme most responsible for the metabolism of 6-mercaptopurine-thiopurine methyltransferase (TPMT). Azathioprine is rapidly converted to 6-mercaptopurine, its active metabolite. So it is possible that differences in TPMT activity may influence the bioequivalence of azathioprine products among individuals, especially those patients deficient in TPMT enzyme activity. However, this possibility has not been evaluated.

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

    Science.gov (United States)

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

    2016-07-01

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

  10. Acceptability and characteristics of 124 human bioequivalence studies with active substances classified according to the Biopharmaceutic Classification System

    Science.gov (United States)

    Ramirez, Elena; Laosa, Olga; Guerra, Pedro; Duque, Blanca; Mosquera, Beatriz; Borobia, Alberto M; Lei, Suhua H; Carcas, Antonio J; Frias, Jesus

    2010-01-01

    AIM The aim of this study was to evaluate the acceptability of 124 bioequivalence (BE) studies with 80 active substances categorized according to the Biopharmaceutics Classification System (BCS) in order to establish if there were different probabilities of proving BE between the different BCS classes. METHODS We evaluated the differences between pharmaceutical products with active substances from different BCS classes in terms of acceptability, number of subjects in the study (n), the point estimates, and intra- and inter-subject coefficients of variation data from BE studies with generic products. RESULTS Out of 124 BE studies 89 (71.77%) were performed with pharmaceutical products containing active substances classified by the BCS. In all BCS classes there were non-bioequivalent pharmaceutical products: 4 out of 26 (15.38%) in class 1, 14 out of 28 (50%) in class 2, 3 out of 22 (13.63%) in class 3 and 1 out of 13 (7.69%) in class 4. When we removed those pharmaceutical products in which intra-subject variability was higher than predicted (2 in class 1 active substances, 9 in class 2 and 2 in class 3) there were still non-BE pharmaceutical products in classes 1, 2 and 3. CONCLUSIONS Comparisons between pharmaceutical products with active substances from the four BCS classes have not allowed us to define differential characteristics of each class in terms of n, inter and intra-subject variability for Cmax or AUC. Despite the usually employed test dissolution methodology proposed as quality control, pharmaceutical products with active substances from the four classes of BCS showed non-BE studies. PMID:21039763

  11. Mining and representing recommendations in actively evolving recommender systems

    DEFF Research Database (Denmark)

    Assent, Ira

    2010-01-01

    Recommender systems provide an automatic means of filtering out interesting items, usually based on past similarity of user ratings. In previous work, we have suggested a model that allows users to actively build a recommender network. Users express trust, obtain transparency, and grow (anonymous......) recommender connections. In this work, we propose mining such active systems to generate easily understandable representations of the recommender network. Users may review these representations to provide active feedback. This approach further enhances the quality of recommendations, especially as topics...... of interest change over time. Most notably, it extends the amount of control users have over the model that the recommender network builds of their interests....

  12. Global recommendations on physical activity for health

    Science.gov (United States)

    ... кий Español Global Strategy on Diet, Physical Activity and Health Menu Diet, Physical Activity & Health Global strategy development ... obesity Documents & publications Related links Global recommendations on physical activity for health WHO developed the "Global Recommendations on Physical Activity ...

  13. A Group Recommender System for Tourist Activities

    Science.gov (United States)

    Garcia, Inma; Sebastia, Laura; Onaindia, Eva; Guzman, Cesar

    This paper introduces a method for giving recommendations of tourist activities to a group of users. This method makes recommendations based on the group tastes, their demographic classification and the places visited by the users in former trips. The group recommendation is computed from individual personal recommendations through the use of techniques such as aggregation, intersection or incremental intersection. This method is implemented as an extension of the e-Tourism tool, which is a user-adapted tourism and leisure application, whose main component is the Generalist Recommender System Kernel (GRSK), a domain-independent taxonomy-driven search engine that manages the group recommendation.

  14. [Bioequivalence studies of pharmaceutical preparations].

    Science.gov (United States)

    Vetchý, D; Frýbortová, K; Rabisková, M; Danecková, H

    2007-01-01

    Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs. The target of such study is to evaluate the therapeutic compatibility of tested drugs (pharmaceutical equivalents or pharmaceutical alternatives). The importance of bioequivalence studies is increasing also due to the large growth of the production and consumption of generic products. Generic products represent approximately 50 % of the whole consumption in many European countries and USA. The search output of bioequivalence study is together with the pharmaceutical quality data of medical product one of the main part of the registration file submitted to a national regulatory authorities. The registration of generic products does not demand complicated and expensive clinical study contrary to original product. The comparison of the original and the generic product via bioequivalence study is suggested as sufficient. The aim of this article is to provide to a medical public a summary about the types of bioequivalence studies, their range, rules of their practise and let them gain their own attitude to this question.

  15. Recommended activation detector cross sections (RNDL-82)

    International Nuclear Information System (INIS)

    Bondars, Kh.Ya.; Lapenas, A.A.

    1984-01-01

    The results of the comparison between measured and calculated average cross sections in 5 benchmark experiments are presented. Calculations have been based on the data from 10 libraries of evaluated cross sections. The recommended library (RNDL-82) of the activation detector cross sections has been created on the basis of the comparison. RNDL-82, including 26 reactions, and the basic characteristics of the detectors are presented. (author)

  16. The importance of bioequivalence study: focus on clopidogrel

    Directory of Open Access Journals (Sweden)

    Arini Setiawati

    2011-05-01

    Full Text Available Bioequivalence (BE study is required to show whether a generic copy product can be interchangeable with the brand innovator product. The aim of this article is to provide the rationale for conducting BE studies, the main products requiring BE studies, the design and conduct of BE studies in general, with focus on clopidogrel. All of the clopidogrel generic products in Indonesia have been shown to be BE to the innovator product Plavix® and they contain API (active pharmaceutical ingredient clopidogrel form 1 that complies with USP 30, 1997 requirements: the R-enantiomer content is not more than 1%. A proof that bioequivalence (BE means therapeutic equivalence (TE is also provided for cardiovascular drugs. Clopidogrel has 2 polymorphic forms, form 1 and form 2, which have the same indications. At least one pivotal study of clopidogrel, CAPRIE, used clopidogrel form 1. An atherothrombotic event may be associated with clopidogrel resistance, which occur in about 4 to 30% of patients treated with conventional doses of clopidogrel. (Med J Indones 2011; 20:149-53Keywords: bioequivalent, clopidogrel

  17. Physical Activity Recommendations in Patients with Chronic Obstructive Pulmonary Disease

    NARCIS (Netherlands)

    Hartman, Jorine E.; Boezen, H. Marike; Zuidema, Menno J.; de Greef, Mathieu H. G.; ten Hacken, Nick H. T.; Boezen, Hendrika

    2014-01-01

    Background: Physical activity recommendations are hardly studied in patients with chronic obstructive pulmonary disease (COPD), and specifically recommendations that are individualized to a patient's aerobic fitness level are not studied. Objectives: To compare individualized (relative) and

  18. Effect of Different Sampling Schedules on Results of Bioavailability and Bioequivalence Studies: Evaluation by Means of Monte Carlo Simulations.

    Science.gov (United States)

    Kano, Eunice Kazue; Chiann, Chang; Fukuda, Kazuo; Porta, Valentina

    2017-08-01

    Bioavailability and bioequivalence study is one of the most frequently performed investigations in clinical trials. Bioequivalence testing is based on the assumption that 2 drug products will be therapeutically equivalent when they are equivalent in the rate and extent to which the active drug ingredient or therapeutic moiety is absorbed and becomes available at the site of drug action. In recent years there has been a significant growth in published papers that use in silico studies based on mathematical simulations to analyze pharmacokinetic and pharmacodynamic properties of drugs, including bioavailability and bioequivalence aspects. The goal of this study is to evaluate the usefulness of in silico studies as a tool in the planning of bioequivalence, bioavailability and other pharmacokinetic assays, e.g., to determine an appropriate sampling schedule. Monte Carlo simulations were used to define adequate blood sampling schedules for a bioequivalence assay comparing 2 different formulations of cefadroxil oral suspensions. In silico bioequivalence studies comparing different formulation of cefadroxil oral suspensions using various sampling schedules were performed using models. An in vivo study was conducted to confirm in silico results. The results of in silico and in vivo bioequivalence studies demonstrated that schedules with fewer sampling times are as efficient as schedules with larger numbers of sampling times in the assessment of bioequivalence, but only if T max is included as a sampling time. It was also concluded that in silico studies are useful tools in the planning of bioequivalence, bioavailability and other pharmacokinetic in vivo assays. © Georg Thieme Verlag KG Stuttgart · New York.

  19. Physical activity recommendations for health: what should Europe do?

    Directory of Open Access Journals (Sweden)

    Fogelholm Mikael

    2010-01-01

    Full Text Available Abstract Background Accumulating scientific evidence shows physical activity to have profound health benefits amenable to substantial public health gains. Accordingly, recommendations on how much and what kind of physical activity enhances health have been issued. The 1995 recommendation from the U.S. Centres for Disease Control and Prevention and the American College of Sports Medicine has been adapted worldwide, including Europe. Recently an extensive review of new evidence was undertaken and refined recommendations were issued by the U.S. Department of Health and Human Services. We summarise the development of physical activity recommendations and consider the need and possible ways to update the current European situation. Discussion The new recommendations include several new elements when compared to the 1995 recommendation, the most notable being the greater emphasis on the contribution of vigorous-intensity activities, and the inclusion of activities for muscle strength and bone health. They also include specific recommendations for young people, middle-aged adults, older adults and some special groups. The existing Pan-European and national physical activity recommendations in Europe are mostly based on the 1995 recommendation and primarily target adults and young people. Thus the degree to which they are compatible with the new recommendations varies. In view of the growing public health importance of physical activity, we discuss the need to review the existing physical activity recommendations at the European level and assess their consistency with the new evidence and the new recommendations. Summary We argue that a review of the current physical activity recommendations in Europe should be undertaken in view of the most recent research evidence. We recommend that such a task should be taken on by WHO Europe in parallel with the ongoing work by WHO global Headquarters. Following this, each country should develop communication

  20. Recommendations for physical activity for pregnant women

    Directory of Open Access Journals (Sweden)

    Mateja Videmšek

    2015-04-01

    Full Text Available Properly selected and prescribed physical activity during pregnancy has a favorable effects on the health of pregnant women and the fetus, and is excellent preparation for childbirth. Absolute and relative contraindications to exercise during pregnancy are well defined, as well as the warning signs to terminate exercise while pregnant. Knowledge of these is essential for physically active pregnant women and exercise professionals that work with pregnant women. Pregnant women should be moderately physically active every day of the week for at least 30 minutes. The term moderate is thoroughly and clearly defined in the guidelines. Resistance exercises during pregnancy are safe but it is advised to use light loads and a large number of repetitions (e.g. 15-20 repetitions. Strength exercises for the pelvic floor muscles deserves a special place during pregnancy. Appropriate forms of physical activity for pregnant women are walking and jogging, swimming and aquatic exercise, cycling, Pilates and yoga, aerobics, fitness and cross-country skiing. Certain forms of physical activity need special adjustments (alpine skiing, ice skating and rollerblading, racket sports, team ball games, horseback riding and scuba diving. 

  1. Comparative bioequivalence assessment of aspirin tablets marketed ...

    African Journals Online (AJOL)

    Purpose: In the last few years, aspirin has become a life saver against cardiovascular accidents. This investigation was carried out to determine possible bioequivalence between regular aspirin and soluble aspirin tablets marketed in Nigeria. Methods: The in vivo bioavailability profiles of three commercial brands of aspirin ...

  2. Analysis of foreign physical activity recommendations and guidelines for schools

    Directory of Open Access Journals (Sweden)

    Jan Pavelka

    2014-06-01

    Full Text Available Background:An adequate level of physical activity is an important part of children's lifestyle. The school environment plays a significant role in the area of interventions and strategies aiming to increase the level of physical activity in children. Objectives: The aim of this study is to analyse foreign recommendations leading to an increased level of physical activity in children and young people in Czech schools. Methods: A systematic search of studies published between 1988 and 2012 in the English language was completed in library databases Medline, Sport Discus, ProQuest, PsychInfo, ERIC, Wiley InterScience using the following keywords: physical activity, guidelines, recommendations, school and youth. The studies were then classified based on abstract and full-text analyses. Using a content analysis the expert team formulated the final recommendations to increase the level of physical activity for schools in the Czech Republic (CR. Results: Out of the total number of 91 identified foreign studies, 25 met the predetermined criteria and were used as a basis for formulating the recommendations. These foreign studies included 15 papers published in USA, two in Australia, two in Great Britain, two in Canada, one in the European Union, one in New Zealand and one international paper (an international consensus of experts from 34 countries. Based on the interpretation of the evidence, its justification and final consensus of the expert team, the basic areas for the recommendations to increase the level of physical activity in schools in the CR were identified. Conclusions: An analysis of foreign recommendations to increase the level of physical activity designed for schools and school facilities is one of the possible methods of formulating domestic recommendations. This recommendation could contribute to deeper understanding of the issue of the deteriorating lifestyle of school-aged children in the CR and reflects the efforts for improvement.

  3. Physical activity recommendations: an alternative approach using energy expenditure.

    Science.gov (United States)

    Mudd, Lanay M; Rafferty, Ann P; Reeves, Mathew J; Pivarnik, James M

    2008-10-01

    Most adults do not meet the American College of Sports Medicine and Centers for Disease Control and Prevention (ACSM/CDC) physical activity recommendations. Even fewer meet the more extreme Institute of Medicine (IOM) physical activity recommendations. Compliance with either recommendation has been conventionally assessed by combining frequencies and durations of self-reported activities. Leisure-time energy expenditure is a cumulative measure of activity that offers an alternative method of defining compliance. To calculate the leisure-time energy expenditure of adults complying with the ACSM/CDC or the IOM physical activity recommendations determined by conventional measures and to reexamine compliance with the IOM recommendation using energy expenditure criteria. National, cross-sectional data from the 2000 Behavioral Risk Factor Surveillance System determined the mode, frequency, and duration of up to two leisure-time activities performed by adults. Four mutually exclusive activity groups (Non-, Low-, ACSM/CDC-, and IOM-Active) were defined on the basis of frequencies and durations of reported activities. Leisure-time energy expenditure (kcal x kg(-1) x wk(-1)) was calculated per respondent. The energy expenditure threshold for meeting the IOM recommendation was calculated as 21 kcal x kg(-1) x wk(-1). Of the 162,669 respondents included in the analyses, 29.9% were Nonactive, whereas 42.3%, 23.3%, and 4.5% were Low-, ACSM/CDC-, and IOM-Active, respectively. Median leisure-time energy expenditure values were 9.0, 27.4, and 63.0 kcal x kg(-1) x wk(-1) for Low-, ACSM/CDC-, and IOM-Active groups, respectively. When using energy expenditure criteria, compliance with the IOM recommendation rose to 27.7% of respondents. Compliance with the IOM physical activity recommendation dramatically increased when assessed by energy expenditure compared with conventional criteria, thereby highlighting the potential bias of conventional methods. A significant proportion of adults

  4. Recommendations of activity restriction in high-risk pregnancy scenarios

    DEFF Research Database (Denmark)

    Bendix, Jane; Hegaard, Hanne Kristine; Bergholt, Thomas

    2015-01-01

    activity restriction more often than obstetricians in five of the nine scenarios, in women with preterm premature rupture of membranes, preterm labour, cervical ripening, total placenta praevia, and intrauterine growth restriction, whereas no differences were found in the remaining scenarios. Compared...... to the obstetricians, the midwives also reported that they expected the recommendation to be more effective. Most midwives and obstetricians reported that they thought strict activity restriction was associated with severe or moderate adverse effect, and recommended antithrombotic prophylaxis. Conclusions: Danish...... obstetricians and midwives prescribe activity restriction in most high-risk pregnancies. The degree of activity restriction and the presumed effect vary between clinicians. This may reflect different attitudes and lack of guidelines based on clinical studies of a possible benefit of activity restriction....

  5. Use of partial AUC to demonstrate bioequivalence of Zolpidem Tartrate Extended Release formulations.

    Science.gov (United States)

    Lionberger, Robert A; Raw, Andre S; Kim, Stephanie H; Zhang, Xinyuan; Yu, Lawrence X

    2012-04-01

    FDA's bioequivalence recommendation for Zolpidem Tartrate Extended Release Tablets is the first to use partial AUC (pAUC) metrics for determining bioequivalence of modified-release dosage forms. Modeling and simulation studies were performed to aid in understanding the need for pAUC measures and also the proper pAUC truncation times. Deconvolution techniques, In Vitro/In Vivo Correlations, and the CAT (Compartmental Absorption and Transit) model were used to predict the PK profiles for zolpidem. Models were validated using in-house data submitted to the FDA. Using dissolution profiles expressed by the Weibull model as input for the CAT model, dissolution spaces were derived for simulated test formulations. The AUC(0-1.5) parameter was indicative of IR characteristics of early exposure and effectively distinguished among formulations that produced different pharmacodynamic effects. The AUC(1.5-t) parameter ensured equivalence with respect to the sustained release phase of Ambien CR. The variability of AUC(0-1.5) is higher than other PK parameters, but is reasonable for use in an equivalence test. In addition to the traditional PK parameters of AUCinf and Cmax, AUC(0-1.5) and AUC(1.5-t) are recommended to provide bioequivalence measures with respect to label indications for Ambien CR: onset of sleep and sleep maintenance.

  6. Motivate: context aware mobile application for activity recommendation

    NARCIS (Netherlands)

    Lin, Y.; Jessurun, A.J.; Vries, de B.; Timmermans, H.J.P.; Keyson, D.

    2011-01-01

    This paper presents the design, implementation and evaluation of a context-aware recommendation system that promotes the adoption of a healthy and active lifestyle. A Smartphone application that provides personalized and contextualized advice based on geo information, weather, user location and

  7. Reflections on Physical Activity and Health: What Should We Recommend?

    Science.gov (United States)

    Warburton, Darren E R; Bredin, Shannon S D

    2016-04-01

    The health benefits of regular physical activity are irrefutable; virtually everyone can benefit from being active. The evidence is overwhelming with risk reductions of at least 20%-30% for more than 25 chronic medical conditions and premature mortality. Even higher risk reductions (ie, ≥ 50%) are observed when objective measures of physical fitness are taken. International physical activity guidelines generally recommend 150 minutes per week of moderate- to vigorous-intensity physical activity. A critical review of the literature indicates that half of this volume of physical activity might lead to marked health benefits. There is compelling evidence to support health promotion strategies that emphasize that health benefits can be accrued at a lower volume and/or intensity of physical activity. Public health policies are needed that reduce the barriers to physical activity participation such that everyone can reap the benefits of physical activity. It is also important to highlight that sedentary time (particularly sitting time) carries independent health risks. The simple message of "move more and sit less" likely is more understandable by contemporary society and is formed on the basis of a strong body of evidence. For practitioners who work directly with clients, it is recommended that an individualized prescription (dosage) that takes into consideration the unique characteristics and needs of the client is provided. Physical activity or exercise promotion should not be done in isolation; it should be part of an integrated approach to enhance healthy lifestyle behaviours. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  8. Significance of metabolites in bioequivalence: losartan potassium as a case study.

    Science.gov (United States)

    Charoo, Naseem Ahmad; Cristofoletti, Rodrigo; Khatri, Aamer Roshanali; Ali, Areeg Anwer

    2014-06-01

    Estimation of metabolite data as a supportive evidence of comparable therapeutic outcome is recommended by various guidance documents. However, a consensus on using it solely to establish bioequivalence (BE) is lacking as parent drug is believed to detect pharmacokinetic differences between test and reference formulations better. Four BE studies of losartan potassium reported in the literature are reviewed. In all the four studies, 90% confidence intervals (CIs) of geometric mean ratios of the test and reference formulations for maximum blood drug concentration (Cmax ) of losartan potassium were outside the acceptable range of 80%-125%, whereas, 90% CIs for its active metabolite, losartan carboxylic acid (LCA), were within the acceptance criteria. Although BE with respect to area under the plasma concentration versus time profile curve was demonstrated in all the cases, BE with respect to Cmax could not be established. However, marketing authorization in all the four cases was granted based on scientific evidence that LCA is 10-40 times more potent than losartan, LCA exhibited higher plasma concentration levels than losartan, pharmacodynamic effects correlate with LCA, and losartan shows wide therapeutic index. Further, widened CI limits for losartan were accepted. Losartan presents an opportunity in the diligence of the principles of quality risk management for selecting moiety on which BE decision must be based. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  9. National Recommendations for Physical Activity and Physical Activity Promotion

    OpenAIRE

    Rütten, Alfred; Pfeifer, Klaus; Banzer, Winfried; Ferrari, Nina; Füzéki, Eszter; Geidl, Wolfgang; Graf, Christine; Hartung, Verena; Klamroth, Sarah; Völker, Klaus; Vogt, Lutz; Abu-Omar, Karim; Burlacu, Ionuţ; Gediga, Günther; Messing, Sven

    2016-01-01

    Always and at any age, regular physical activity can act as a powerful elixir with a beneficial effect on health and well-being. The wide variety of health effects that physical activity can have, for example on our cardiovascular system, back and joints, is scientifically well proven. At the same time, we spend most of our time sitting – at school, at the office or in the car. Our bodies, however, want to be on the move! This fundamental instinct is deeply rooted in human nature and this bas...

  10. Impact of Chiral Bioanalytical Methods on the Bioequivalence of Ibuprofen Products Containing Ibuprofen Lysinate and Ibuprofen Base.

    Science.gov (United States)

    García-Arieta, Alfredo; Ferrero-Cafiero, Juan Manuel; Puntes, Montse; Gich, Ignasi; Morales-Alcelay, Susana; Tarré, Maite; Font, Xavier; Antonijoan, Rosa Maria

    2016-05-01

    The purpose was to assess the impact of the use of a chiral bioanalytical method on the conclusions of a bioequivalence study that compared two ibuprofen suspensions with different rates of absorption. A comparison of the conclusion of bioequivalence between a chiral method and an achiral approach was made. Plasma concentrations of R-ibuprofen and S-ibuprofen were determined using a chiral bioanalytical method; bioequivalence was tested for R-ibuprofen and for S-ibuprofen separately and for the sum of both enantiomers as an approach for an achiral bioanalytical method. The 90% confidence interval (90% CI) that would have been obtained with an achiral bioanalytical method (90% CI: Cmax: 117.69-134.46; AUC0 (t) : 104.75-114.45) would have precluded the conclusion of bioequivalence. This conclusion cannot be generalized to the active enantiomer (90% CI: Cmax : 103.36-118.38; AUC0 (t) : 96.52-103.12), for which bioequivalence can be concluded, and/or the distomer (90% CI: Cmax : 132.97-151.33; AUC0 (t) : 115.91-135.77) for which a larger difference was observed. Chiral bioanalytical methods should be required when 1) the enantiomers exhibit different pharmacodynamics and 2) the exposure (AUC or Cmax ) ratio of enantiomers is modified by a difference in the rate of absorption. Furthermore, the bioequivalence conclusion should be based on all enantiomers, since the distomer(s) might not be completely inert, in contrast to what is required in the current regulatory guidelines. In those cases where it is unknown if the ratio between enantiomers is modified by changing the rate of absorption, chiral bioanalytical methods should be employed unless enantiomers exhibit the same pharmacodynamics. Chirality 28:429-433, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  11. Bioequivalence assessment of two formulations of ibuprofen

    Directory of Open Access Journals (Sweden)

    Al-Talla ZA

    2011-10-01

    , therefore, Doloraz was considered bioequivalent to Brufen. Keywords: ibuprofen, bioequivalence study, pharmacokinetics

  12. Bioequivalence of three florfenicol preparations in broilers

    Directory of Open Access Journals (Sweden)

    Husamettin Ekici

    2014-12-01

    Full Text Available This study was aimed to determine the bioequivalence of three different preparations of florfenicol using non-drugged broiler chickens. A total of 28 broiler chickens aging 30-day were divided into four equal groups; these were Group I, II, III, and IV. The birds of Group I (for effective substance were given intravenous (i.v. administration of florfenicol dosed at 40 mg/kg body weight (b.wt.. The birds of Group II (for reference drug, Group III (for test-1 drug, and Group IV (for test-2 drug received florfenicol preparations with water (dosed at 40 mg/kg b.wt. through intracrop administration. Blood samples were collected periodically from the birds of all four groups, and blood plasma was separated. Levels of florfenicol and its metabolite (florfenicol amine in the plasma were measured by High Performance Liquid Chromatography (HPLC. In this study, the limit of detection (LOD for florfenicol and florfenicol amine were recorded as 0.017 and 0.78 µg/mL, respectively. On the other hand, the recovery of florfenicol and florfenicol amine were 83.4-84.6 and 82.2-83.8%, respectively. Based on the values of area under the curve (AUC, maximum concentration (Cmax, and time to maximum concentration (Tmax, test-1 drug was found to be acceptable, whereas test-2 drug was remained below the acceptable limits (80-125% of AUC and Cmax. Thus, it was concluded that test-1 drug was bioequivalent as compared to the reference drug.

  13. SNS Sample Activation Calculator Flux Recommendations and Validation

    Energy Technology Data Exchange (ETDEWEB)

    McClanahan, Tucker C. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States). Spallation Neutron Source (SNS); Gallmeier, Franz X. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States). Spallation Neutron Source (SNS); Iverson, Erik B. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States). Spallation Neutron Source (SNS); Lu, Wei [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States). Spallation Neutron Source (SNS)

    2015-02-01

    The Spallation Neutron Source (SNS) at Oak Ridge National Laboratory (ORNL) uses the Sample Activation Calculator (SAC) to calculate the activation of a sample after the sample has been exposed to the neutron beam in one of the SNS beamlines. The SAC webpage takes user inputs (choice of beamline, the mass, composition and area of the sample, irradiation time, decay time, etc.) and calculates the activation for the sample. In recent years, the SAC has been incorporated into the user proposal and sample handling process, and instrument teams and users have noticed discrepancies in the predicted activation of their samples. The Neutronics Analysis Team validated SAC by performing measurements on select beamlines and confirmed the discrepancies seen by the instrument teams and users. The conclusions were that the discrepancies were a result of a combination of faulty neutron flux spectra for the instruments, improper inputs supplied by SAC (1.12), and a mishandling of cross section data in the Sample Activation Program for Easy Use (SAPEU) (1.1.2). This report focuses on the conclusion that the SAPEU (1.1.2) beamline neutron flux spectra have errors and are a significant contributor to the activation discrepancies. The results of the analysis of the SAPEU (1.1.2) flux spectra for all beamlines will be discussed in detail. The recommendations for the implementation of improved neutron flux spectra in SAPEU (1.1.3) are also discussed.

  14. Large ethnic variations in recommended physical activity according to activity domains in Amsterdam, the Netherlands

    NARCIS (Netherlands)

    de Munter, Jeroen S. L.; van Valkengoed, Irene G. M.; Agyemang, Charles; Kunst, Anton E.; Stronks, Karien

    2010-01-01

    ABSTRACT: Purpose: The level of recommended physical activity (PA) is met less frequently by people from some ethnic minorities than others. We explored whether these differences in recommended PA between ethnic minority groups and the general population varied by domain and type of

  15. Are marketed topical metronidazole creams bioequivalent? Evaluation by in vivo microdialysis sampling and tape stripping methodology

    DEFF Research Database (Denmark)

    Garcia Ortiz, Patricia Elodia; Hansen, S H; Shah, Surendra P.

    2011-01-01

    To evaluate the bioequivalence of 3 marketed topical metronidazole formulations by simultaneous dermal microdialysis and stratum corneum sampling by the tape stripping methodology, and to compare the techniques as tools for the determination of bioequivalence.......To evaluate the bioequivalence of 3 marketed topical metronidazole formulations by simultaneous dermal microdialysis and stratum corneum sampling by the tape stripping methodology, and to compare the techniques as tools for the determination of bioequivalence....

  16. Bioequivalence assessment of two formulations of ibuprofen

    KAUST Repository

    Al-Talla, Zeyad

    2011-10-19

    Background: This study assessed the relative bioavailability of two formulations of ibuprofen. The first formulation was Doloraz , produced by Al-Razi Pharmaceutical Company, Amman, Jordan. The second forumulation was Brufen , manufactured by Boots Company, Nottingham, UK. Methods and results: A prestudy validation of ibuprofen demonstrated long-term stability, freeze-thaw stability, precision, and accuracy. Twenty-four healthy volunteers were enrolled in this study. After overnight fasting, the two formulations (test and reference) of ibuprofen (100 mg ibuprofen/5 mL suspension) were administered as a single dose on two treatment days separated by a one-week washout period. After dosing, serial blood samples were drawn for a period of 14 hours. Serum harvested from the blood samples was analyzed for the presence of ibuprofen by high-pressure liquid chromatography with ultraviolet detection. Pharmacokinetic parameters were determined from serum concentrations for both formulations. The 90% confidence intervals of the ln-transformed test/reference treatment ratios for peak plasma concentration and area under the concentration-time curve (AUC) parameters were found to be within the predetermined acceptable interval of 80%-125% set by the US Food and Drug Administration. Conclusion: Analysis of variance for peak plasma concentrations and AUC parameters showed no significant difference between the two formulations and, therefore, Doloraz was considered bioequivalent to Brufen. 2011 Al-Talla et al, publisher and licensee Dove Medical Press Ltd.

  17. Large ethnic variations in recommended physical activity according to activity domains in amsterdam, the netherlands

    Directory of Open Access Journals (Sweden)

    Kunst Anton E

    2010-11-01

    Full Text Available Abstract Purpose The level of recommended physical activity (PA is met less frequently by people from some ethnic minorities than others. We explored whether these differences in recommended PA between ethnic minority groups and the general population varied by domain and type of culturally-specific activity. Methods Participants were sampled from the population based SUNSET study and were from ethnic Dutch (n = 567, Hindustani-Surinamese (n = 370 and African-Surinamese (n = 689 descent. The validated SQUASH-questionnaire measured PA for the following domains: commuting, occupation, household, leisure time. Culturally-specific activities were added as extra question within the leisure time domain. The effect of each domain on ethnic differences in recommended PA prevalence was examined by odds-ratio (OR analysis through recalculating recommended PA, while, in turn, excluding the contribution of each domain. Results In the ethnic Dutch population, more vigorous PA in commuting and leisure time was reported compared to the Surinamese groups. The Hindustani-Surinamese and African-Surinamese reported more walking as commuting activity, while the Dutch group reported cycling more frequently. Ethnic differences in recommended PA became smaller in both Surinamese groups compared with the Dutch after removing commuting activity, for example, in Hindustani-Surinamese men (OR = 0.92, 95%CI: 0.62-1.37 vs. OR = 1.33, 0.89-2.00 and women (OR = 1.61, 1.12-2.32 vs. OR = 2.03, 1.41-2.92. Removing occupational activity resulted in larger ethnic differences in both groups compared with the Dutch. Smaller effects were found for yoga and dancing, leisure time and household activities. Conclusion This study shows that differences in PA between ethnic minority groups and the general population vary according to the activity domain. The results indicate that including all relevant domains and activities is essential for assessment of ethnic differences in recommended

  18. Effect of the Wetting Agent Sodium Lauryl Sulfate on the Pharmacokinetics of Alectinib: Results From a Bioequivalence Study in Healthy Subjects.

    Science.gov (United States)

    Morcos, Peter N; Parrott, Neil; Banken, Ludger; Timpe, Carsten; Lindenberg, Marc; Guerini, Elena; Dall, Georgina; Bogman, Katrijn; Sturm, Carolina; Zeaiter, Ali; Martin-Facklam, Meret; Phipps, Alex

    2017-05-01

    The anaplastic lymphoma kinase (ALK) inhibitor alectinib is an effective treatment for ALK-positive non-small-cell lung cancer. This bioequivalence study evaluated the in vivo performance of test 3 formulations with the reduced wetting agent sodium lauryl sulfate (SLS) content. This randomized, 4-period, 4-sequence, crossover study compared alectinib (600 mg) as 25%, 12.5%, and 3% SLS hard capsule formulations with the reference 50% SLS clinical formulation in healthy subjects under fasted conditions (n = 49), and following a high-fat meal (n = 48). Geometric mean ratios and 90% confidence intervals (CIs) for C max , AUC 0-last , and AUC 0-∞ of alectinib, its major active metabolite, M4, and alectinib plus M4 were determined for the test formulations versus the reference formulation. Bioequivalence was concluded if the 90%CIs were within the 80% to 125% boundaries. The 25% SLS formulation demonstrated bioequivalence to the reference 50% SLS formulation for C max , AUC 0-last , and AUC 0-∞ of alectinib, M4, and alectinib plus M4 under both fasted and fed conditions. Further reductions in SLS content (12.5% and 3% SLS) did not meet the bioequivalence criteria. Cross-group comparisons showed an approximately 3-fold positive food effect. Reducing SLS to 25% resulted in a formulation that is bioequivalent to the current 50% SLS formulation used in alectinib pivotal trials. © 2016, The American College of Clinical Pharmacology.

  19. Pharmacokinetic comparison and bioequivalence evaluation of losartan/ hydrochlorothiazide tablet between Asian Indian and Japanese volunteers.

    Science.gov (United States)

    Kumar, Sudershan; Monif, Tausif; Khuroo, Arshad; Reyar, Simrit; Jain, Rakesh; Singla, Ajay K; Kurachi, Kazuya

    2014-01-01

    To demonstrate the bioequivalence between the test and reference formulations of losartan/hydrochlorothiazide 50 + 12.5 mg tablet and evaluate the effect of ethnicity on pharmacokinetics properties of losartan, losartan carboxylic acid and hydrochlorothiazide on healthy Asian Indian and Japanese volunteers. Randomized, open-label, crossover, bioavailability studies were conducted separately in healthy Asian Indian and Japanese volunteers. One tablet either of test or of reference product was administered after 10 hours of overnight fasting. After dosing, serial blood samples were collected for a period of 48 hours for both the studies. Plasma samples were analyzed for losartan, losartan carboxylic acid and hydrochlorothiazide by a validated liquid chromatographic and mass spectrometric method (LC-MS/MS). The pharmacokinetic parameters AUC0-t, AUC0-∞, Cmax, tmax, and other pharmacokinetics parameters were determined from plasma concentration-time profiles for both test and reference formulations of losartan/hydrochlorothiazide 50 + 12.5 mg tablets. Statistical evaluations were done to evaluate bioequivalence between generic test formulation (EPR0001) and Japanese reference product (Preminent®). Losartan, losartan carboxylic acid and hydrochlorothiazide were well tolerated by subjects in all periods of each study under fasted conditions. No serious adverse events were observed. The ratios of least square means for AUC0-t and Cmax and the affiliated 90% confidence intervals were within acceptance range recommended by PMDA. Marginal differences were observed in pharmacokinetic values of Asian Indian and Japanese volunteers. The results of these bioavailability studies indicate that the test formulation of losartan/hydrochlorothiazide 50 + 12.5 mg (EPR0001) tablets is bioequivalent to marketed Preminent® reference formulation in Asian Indian and Japanese volunteers, when administered under fasting conditions. Both test and reference formulations were well tolerated

  20. Bioequivalence of isoniazid in a two drug fixed dose combination and in a single drug dosage form.

    Science.gov (United States)

    Agrawal, S; Kaul, C L; Panchagnula, R

    2001-08-01

    To increase the patient compliance and reduce the risk of drug resistant strains, WHO and IUATLD recommend the use of Fixed Dose Combination (FDC) tablets as a routine therapeutic regimen in Directly Observed Treatment Shortcourse (DOTS). But the main issue in the use of FDC is the quality of the formulation. At present WHO and IUATLD suggest the bioequivalence assessment of only rifampicin from FDC compared to separate formulations. For the therapeutic effectiveness all the components of the FDCs should be bioavailable at tissue site. Also, the primary and acquired resistance rate of isoniazid is much higher compared to other anti-tubercular drugs. Hence, a comparative bioavailability study of isoniazid from a two drugs FDC compared to a separate formulation was carried out on a group of 12 healthy volunteers. When evaluated by normal or log transformed confidence interval, Two Way ANOVA and Hauschke analysis, the bioequivalence limits for AUC0-8 and AUC0-24 were within 0.8-1.25. For Cmax and Tmax, these limits were within 0.7-1.43. Hence, isoniazid from a FDC formulation was found to be bioequivalent to a separate formulation at same dose levels.

  1. Bioequivalence of ciprofloxacin tablet formulations assessed in Indonesian volunteers.

    Science.gov (United States)

    Harahap, Y; Prasaja, B; Indriati, E; Lusthom, W; Lipin

    2007-06-01

    Determination of the bioequivalence of two ciprofloxacin tablet formulations (test formulation manufactured by Novell Pharmaceutical Laboratories, Indonesia, reference formulation from Quimica Farmaceutica Bayer, Spain). 24 healthy volunteers received each of the two ciprofloxacin formulations at a dose of 500 mg in a 2-way crossover design. Blood samples were obtained prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and24h after drug administration. Plasma concentrations of ciprofloxacin were monitored using high-performance liquid chromatography over a period of 24 h after administration. The pharmacokinetics parameter AUC0-24h, AUC0-infinity and Cmax were tested for bioequivalence after log-transformation of data and ratios of tmax were evaluated non-parametrically. The point estimates and 90% confidence intervals for AUC0-24h, AUC0-infinity and Cmax were 97.55% (92.71 - 102.6%), 97.63% (92.90 - 102.59%) and 95.84% (89.95 - 102.10%), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration guidelines. These results indicate that two medications of ciprofloxacin are bioequivalent and, thus, may be prescribed interchangeably.

  2. Bioequivalence study on two brands of 10% enrofloxacin oral ...

    African Journals Online (AJOL)

    A bioequivalence of two brands of 10% enrofloxacin was tested in broiler chickens using a parallel design at 20 mg/kg bodyweight orally. Blood was sampled before and after drug administration for 24 hours. Plasma enrofloxacin concentrations were analyzed using microbiological assay. Peak plasma concentrations ...

  3. Recommended level of physical activity and health-related quality of life among Japanese adults

    OpenAIRE

    Nakamura Yoshio; Oka Koichiro; Shibata Ai; Muraoka Isao

    2007-01-01

    Abstract Background The benefits of a recommended level of physical activity on physiological health indicators such as morbidity and mortality are well-accepted, but less research has addressed whether or not the association between the recommended level of physical activity and a health-related quality of life (HRQOL) exists in the Japanese population. Thus, the present study examined whether the recommended physical activity would be associated with HRQOL in the general Japanese middle-age...

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

    Science.gov (United States)

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

    2015-09-01

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

  5. Intrapersonal, behavioral, and environmental factors associated with meeting recommended physical activity among rural Latino youth.

    Science.gov (United States)

    Perry, Cynthia K; Saelens, Brian E; Thompson, Beti

    2011-11-01

    This study aimed to identify intrapersonal, behavioral, and environmental factors associated with engaging in recommended levels of physical activity among rural Latino middle school youth. Data were from an anonymous survey of 773 Latino youth (51% female) about level of and barriers and motivators to physical activity, risk behaviors, and park use. Logistic regression models identified factors correlated with meeting recommended levels of physical activity (5 days or more 3 60 min/day). Thirty-four percent of girls and 41% of boys reported meeting this physical activity recommendation. Participation in an organized after school activity (p < .001) and in physical education (PE) classes 5 days a week (p < .001) were strongly associated with meeting recommended physical activity level. Making PE available 5 days a week and creating opportunities for organized after school physical activity programs may increase the number of rural Latino middle school youth who meet recommended physical activity level.

  6. Promotion of Active Aging using a tailored recommendation system

    NARCIS (Netherlands)

    Cabrita, M.; Vollenbroek-Hutten, Miriam Marie Rosé

    Active Aging deals with the support and integration of the elderly population in a society focusing on improving physical and mental well-being. Persuasive technology provides solutions for tailored interventions aiming at maintaining an active lifestyle. The present paper introduces the initial

  7. Development of a new benazepril hydrochloride chewable tablet and evaluation of its bioequivalence for treatment of heart failure in dogs.

    Science.gov (United States)

    Qian, M; Chen, T; Zhou, D; Zhang, Z; Zhang, Q; Tang, S; Xiao, X

    2016-02-01

    The aim of the study was to develop a new chewable benazepril hydrochloride(BH) tablet, investigate its physical properties, and evaluate its bioequivalence with the branded formulation (Fortekor). A corrective agent was included in the formula to improve its palatability and convenience for administration to dogs. The tablet remained stable in light, heat, and humidity tests, and its physical properties such as hardness, uniformity of content, and dissolution rate were highly consistent with the technical standards. After single and repeated administrations to eight beagles and single dose to 14 mongrel dogs (0.5 mg/kg p.o.), plasma BH and its active metabolite, benazeprilat (BZ), were detected. There was no significant difference in the major pharmacokinetic parameters (Cmax , Tmax, and AUC₀₋₂₄) between the two formulations. The 90% confidence intervals calculated for the ratios of area under the time-concentration curve (AUC₀₋₂₄) were 92.4-116.3% for BH and 89.9-102.3% for BZ, within the accepted range for bioequivalence of 80-125%. The results showed our new chewable tablet is bioequivalent to the commercial product and suitable for addition to the benazepril product family for the treatment of heart failure in dogs. © 2015 John Wiley & Sons Ltd.

  8. Bioequivalence of a new liquid formulation of benazepril compared with the reference tablet product.

    Science.gov (United States)

    Kelers, K; Devi, J L; Anderson, G A; Zahra, P; Vine, J H; Whittem, T

    2013-08-01

    To compare the bioequivalence and 'switchability' of two formulations of benazepril (tablet and liquid) after oral administration. Randomised cross-over design, followed by parallel comparison. Twelve mixed-breed dogs were administered either a tablet (Group A) or liquid formulation (Group B) of benazepril orally at 0.45 mg/kg daily for 4 days. With no washout period, the dogs then received the alternative treatment at the same dose for a further 4 days. Blood samples taken prior to treatment and serially after treatment were analysed for plasma concentrations of benazepril and benazeprilat and the activity and concentration of angiotensin-converting enzyme (ACE). The calculated percentage inhibition of ACE was defined as the primary outcome variable. No statistically significant differences were found between groups A and B for any variable evaluated. The mean (± SD) percentage of ACE inhibition was 85.5 ± 7.04% for the liquid formulation and 85.9 ± 6.66% for the tablet formulation. The mean of the ratios was 1.00 (80% confidence interval 0.96-1.04). No evaluated effect term (sequence, formulation or period) had any statistical effect on any outcome variable. This study supports a conclusion that, based on pharmacodynamic response, the liquid formulation of benazepril is bioequivalent to the reference tablet formulation. Further, the lack of a sequence effect supports the switchability of these two formulations. © 2013 Australian Veterinary Association.

  9. Regulatory and clinical aspects of psychotropic medicinal products bioequivalence.

    Science.gov (United States)

    Bałkowiec-Iskra, Ewa; Cessak, Grzegorz; Kuzawińska, Olga; Sejbuk-Rozbicka, Katarzyna; Rokita, Konrad; Mirowska-Guzel, Dagmara

    2015-07-01

    Introduction of generic medicinal products to the market has increased access to modern therapies but also enabled significant reduction in their cost, leading to containment of public expenditures on medicinal products reimbursement. The critical assessment of bioequivalence of any reference medicinal product and its counterpart is based on comparison of their rate and extent of absorption. It is assumed that two medicinal products are bioequivalent when their rate and extent of absorption do not show significant differences when administered at the same dose under similar experimental conditions. Bioequivalent medicinal products are declared to be also therapeutically equivalent and can be used interchangeably. However, despite regulatory declaration, switching from reference to generic drugs is often associated with concerns of healthcare providers about decreased treatment effectiveness or occurrence of adverse drug reactions. The aim of this article is to provide a description of rules that guide registration of generic medicinal products in the European Union and to analyze specific examples from the scientific literature concerning therapeutic equivalence of reference and generic antidepressant and antipsychotic medicinal products. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.

  10. Recommended level of physical activity and health-related quality of life among Japanese adults

    Directory of Open Access Journals (Sweden)

    Nakamura Yoshio

    2007-11-01

    Full Text Available Abstract Background The benefits of a recommended level of physical activity on physiological health indicators such as morbidity and mortality are well-accepted, but less research has addressed whether or not the association between the recommended level of physical activity and a health-related quality of life (HRQOL exists in the Japanese population. Thus, the present study examined whether the recommended physical activity would be associated with HRQOL in the general Japanese middle-aged population. Methods Data were obtained from 1211 male and female respondents (39.4 ± 10.9 year, mean ± SD from an Internet-based survey of registrants of an Internet research service. Physical activity level was estimated from the short form of the International Physical Activity Questionnaire. HRQOL was assessed with the Medical Outcomes Survey Short Form-8 questionnaire (SF-8. Based on the current national guidelines for exercise in Japan, respondents were divided into a recommended group, an insufficient group, and an inactive group according to their estimated weekly physical activity level. Multivariate analyses of covariance were utilized. Results Across both genders, the recommended group had significantly higher physical functioning (PF scores than the inactive group (p Conclusion Individuals who attained the recommended level of physical activity had better scores on some dimensions of HRQOL than those who did not, suggesting that the recommended level of physical activity may be applicable not only to the physiological objective outcomes but also to some dimensions in both the physical and mental aspects of HRQOL.

  11. Adherence to physical activity recommendations and its associated factors: an interregional population-based study

    Directory of Open Access Journals (Sweden)

    Ala'a Alkerwi

    2015-03-01

    Full Text Available Background. Though the influence of physical activity in preventing cardiovascular diseases is well documented, only a few comparative studies have determined the degree of adherence to physical activity recommendations among populations and identified the demographic, socioeconomic, behavioural and health-related factors associated with good compliance. Design and methods. Cross-sectional interregional NESCaV survey of 3133 subjects compared three populations, Luxembourg, Lorraine (France and Wallonia (Belgium, by using the International Physical Activity Questionnaire. Age and gender prevalence rates of physical activity were standardized to the European population. Results. The likelihood to meet the recommendations was higher in Luxembourg, after adjustment for age, gender, education, employment, weight status, morbidity score, health perception and level of importance attributed to the practice of physical activity (P<0.0001. The odds for meeting the recommendations were significantly higher among those with secondary than tertiary education. Compared to good self-health perception, subjects with poor or fair self-perceived health were less likely to meet the recommendations; this also applied to those attributing little or enough importance to physical activity compared with great importance. Conclusions. Region, education, self-perceived health and perception of importance of physical activity were emerged as independent determinants of meeting the recommendations. Awareness of the positive health effects of physical activity might thus be crucial for motivating the people to become more active. Further research is needed to explore potential region-specific factors which might explain the difference in population behaviours with respect to physical activity.

  12. LANet: An Enriched Knowledgebase for Location-aware Activity Recommendation System

    OpenAIRE

    Mazumder, Sahisnu

    2016-01-01

    Accumulation of large amount of location-specific reviews on web due to escalating popularity of Location-based Social Networking platforms like Yelp, Foursquare, Brightkite etc. in recent years, has created the opportunity to discover location-specific activities and develop myriads of location-aware activity recommendation applications. The performance and popularity of such recommendation applications greatly depend on the richness and accuracy of the back-end knowledgebase, which intern i...

  13. [Adherence to physical activity recommendations in a hypertensive primary care population].

    Science.gov (United States)

    Guitard Sein-Echaluce, M Luisa; Torres Puig-gros, Joan; Farreny Justribó, Divina; Gutiérrez Vilaplana, Josep M; Martínez Orduna, Miguela; Artigues Barberá, Eva M

    2013-01-01

    To determine the prevalence of adherence to physical activity recommendations in the hypertensive population of Lerida (Spain) attended in primary care and to identify related factors. A cross sectional study was carried out in hypertensive adults. The dependent variable was adherence to physical activity recommendations measured with the Minnesota Questionnaire. The independent variables were sociodemographic factors, the information received, and attitudes to physical activity. A total of 786 hypertensive patients participated in this study; 53.9% were women and the mean age was 66.0±10.2 years. Adherence to recommendations was found in 64.3% (95% CI: 60.9-67.6); this percentage was 65.2% in men (95% CI: 60.2-70.0) and 63.4% in women (95% CI: 58.8-67.9). Greater adherence was associated with age in men and with residence in a rural area in women. In both genders, greater adherence was associated with unpaid work and with having a favorable attitude to physical activity. No association was observed with the number of recommendations received in the last 6 months. More than half the hypertensive population adhered to physical activity recommendations. To improve physical activity levels, recommendations can be tailored to the attitudes of individual patients. Copyright © 2012 SESPAS. Published by Elsevier Espana. All rights reserved.

  14. An Ontology-Based Tourism Recommender System Based on Spreading Activation Model

    Science.gov (United States)

    Bahramian, Z.; Abbaspour, R. Ali

    2015-12-01

    A tourist has time and budget limitations; hence, he needs to select points of interest (POIs) optimally. Since the available information about POIs is overloading, it is difficult for a tourist to select the most appreciate ones considering preferences. In this paper, a new travel recommender system is proposed to overcome information overload problem. A recommender system (RS) evaluates the overwhelming number of POIs and provides personalized recommendations to users based on their preferences. A content-based recommendation system is proposed, which uses the information about the user's preferences and POIs and calculates a degree of similarity between them. It selects POIs, which have highest similarity with the user's preferences. The proposed content-based recommender system is enhanced using the ontological information about tourism domain to represent both the user profile and the recommendable POIs. The proposed ontology-based recommendation process is performed in three steps including: ontology-based content analyzer, ontology-based profile learner, and ontology-based filtering component. User's feedback adapts the user's preferences using Spreading Activation (SA) strategy. It shows the proposed recommender system is effective and improves the overall performance of the traditional content-based recommender systems.

  15. Use of Social Networking Sites and Adherence to Physical Activity and Screen Time Recommendations in Adolescents.

    Science.gov (United States)

    Sampasa-Kanyinga, Hugues; Chaput, Jean-Philippe

    2016-05-01

    Adolescents are recommended to achieve ≥ 60 min/day of moderate-to-vigorous physical activity (PA) and ≤2 h/day of screen time (ST). This study examined the relationships between the use of social networking sites (SNSs) and adherence to PA and ST recommendations in a large sample of Canadian adolescents. This cross-sectional school-based survey included a representative sample of 9388 students in grades 7 to 12 across Ontario, Canada. After adjustment for several confounding variables, results showed that male adolescents who use SNSs for fewer hours (≤ 1 h/day) had greater odds of adherence to PA and to both PA and ST recommendations concurrently, while those who use it for more hours (≥ 3 h/day) had lower odds of adherence to the ST recommendation. Female adolescents who use SNSs for more hours had lower odds of adherence to the ST recommendation (use of SNSs ≥ 2 h/day) and to both PA and ST recommendations concurrently (use of SNSs ≥ 5 h/day). Heavy use of SNSs has a negative influence on the adherence to the ST recommendation in both males and females; however, infrequent use of SNSs was related to the adherence to the PA recommendation and concurrent adherence to both recommendations in males only.

  16. AN ONTOLOGY-BASED TOURISM RECOMMENDER SYSTEM BASED ON SPREADING ACTIVATION MODEL

    Directory of Open Access Journals (Sweden)

    Z. Bahramian

    2015-12-01

    Full Text Available A tourist has time and budget limitations; hence, he needs to select points of interest (POIs optimally. Since the available information about POIs is overloading, it is difficult for a tourist to select the most appreciate ones considering preferences. In this paper, a new travel recommender system is proposed to overcome information overload problem. A recommender system (RS evaluates the overwhelming number of POIs and provides personalized recommendations to users based on their preferences. A content-based recommendation system is proposed, which uses the information about the user’s preferences and POIs and calculates a degree of similarity between them. It selects POIs, which have highest similarity with the user’s preferences. The proposed content-based recommender system is enhanced using the ontological information about tourism domain to represent both the user profile and the recommendable POIs. The proposed ontology-based recommendation process is performed in three steps including: ontology-based content analyzer, ontology-based profile learner, and ontology-based filtering component. User’s feedback adapts the user’s preferences using Spreading Activation (SA strategy. It shows the proposed recommender system is effective and improves the overall performance of the traditional content-based recommender systems.

  17. Pharmacokinetic and bioequivalence study of itopride HCl in healthy volunteers.

    Science.gov (United States)

    Cho, Kyung-Jin; Cho, Wonkyung; Cha, Kwang-Ho; Park, Junsung; Kim, Min-Soo; Kim, Jeong-Soo; Hwang, Sung-Joo

    2010-01-01

    In the present study two different formulations containing 50 mg itopride HCl (N-[4-12-(dimethylamino)ethoxylbenzyl]-3,4-dimethoxybenzamide HCl, CAS 122898-67-3) were compared in 28 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, crossover design in 28 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 24 h. The serum concentrations of itopride HCl were determined using a specific and sensitive HPLC method with fluorescence detection. The detection limit of itopride HCl was 5 ng/ml and no endogenous compounds were found to interfere with analysis. The mean AUC(0-4h), AUC(0 --> infinity), C(max), T(max) and T1/2 were 865.28 ng x h/ml, 873.04 ng x h/ml, 303.72 ng/ml, 0.75 h, and 2.95 h, respectively, for the test formulations, and 833.00 ng x h/ml, 830.97 ng x h/ml, 268.01 ng/ml, 0.78 h, and 2.83 h, respectively, for the reference formulation. Both primary target parameters AUC(0 --> infinity) and C(max) were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of AUC(0 --> infinity) and C(max) were 100.57%-109.56% and 105.46%-121.18%, respectively, and were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of itopride HCl are considered to be bioequivalent.

  18. Bioequivalence of a new cyclosporine a formulation to Neoral.

    Science.gov (United States)

    David-Neto, Elias; Kakehashi, Erica; Alves, Cristiane Feres; Pereira, Lilian M; de Castro, Maria Cristina R; de Mattos, Renata Maciel; Sumita, Nairo Massakazu; Romano, Paschoalina; Mendes, Maria Elizabete; Nahas, William Carlos; Ianhez, Luiz Estevam

    2004-02-01

    New cyclosporine A (CsA) formulations must prove their bioequivalence to Neoral, the reference CsA formulation, to allow free prescription for the patients. The aim of this study was to compare the pharmacokinetics (PK) of a new CsA formulation (Zinograf-ME), produced by Strides-Arcolab, to Neoral and to demonstrate their interchangeability in stable renal transplant recipients. Twelve-hour PK studies were obtained from 18 (13 M/5 F) adult patients (mean age 44.7 +/- 12 years). They received their renal allografts from 13 cadaver and 5 living donors. Before enrollment, all patients were receiving a third generic CsA for a mean of 48 months. Nine patients were also under azathioprine and 9 under mycophenolate mofetil; 17 received prednisone. A single oral dose of either Zinograf or Neoral was administered. The first PK study was performed with one formulation, and 1 week later, a second PK was done with the other formulation. During the washout period, patients continued taking the third CsA formulation. The drug substitution was done milligram-for-milligram. The CsA whole-blood level was measured by TDx immunoassay. Mean +/- SD of area under the curve (AUC), maximum concentration (C(max)), and concentration at the second hour (C2) of Zinograf were not statistically different from those with Neoral (4019 +/- 1466 vs 3971 +/- 1325 ng x h/mL, 998 +/- 376 vs 1021 +/- 356 ng/mL, and 707 +/- 254 vs 734 +/- 229 ng/mL, respectively). In the same way, the Zinograf 90% confidence interval for either C(max) (-123, +77 ng/mL) or AUC (-214, +311 ng.mL/h) were within the Neoral bioequivalence interval for the same parameters (+/-204 ng/mL and +/-794 ng x mL/h, respectively). These data demonstrate that the ZinografME CsA formulation is bioequivalent to Neoral.

  19. The bootstrap and Bayesian bootstrap method in assessing bioequivalence

    International Nuclear Information System (INIS)

    Wan Jianping; Zhang Kongsheng; Chen Hui

    2009-01-01

    Parametric method for assessing individual bioequivalence (IBE) may concentrate on the hypothesis that the PK responses are normal. Nonparametric method for evaluating IBE would be bootstrap method. In 2001, the United States Food and Drug Administration (FDA) proposed a draft guidance. The purpose of this article is to evaluate the IBE between test drug and reference drug by bootstrap and Bayesian bootstrap method. We study the power of bootstrap test procedures and the parametric test procedures in FDA (2001). We find that the Bayesian bootstrap method is the most excellent.

  20. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice.

    Science.gov (United States)

    Anderson, Jaclyn; Caplan, Liron; Yazdany, Jinoos; Robbins, Mark L; Neogi, Tuhina; Michaud, Kaleb; Saag, Kenneth G; O'Dell, James R; Kazi, Salahuddin

    2012-05-01

    Although the systematic measurement of disease activity facilitates clinical decision making in rheumatoid arthritis (RA), no recommendations currently exist on which measures should be applied in clinical practice in the US. The American College of Rheumatology (ACR) convened a Working Group (WG) to comprehensively evaluate the validity, feasibility, and acceptability of available RA disease activity measures and derive recommendations for their use in clinical practice. The Rheumatoid Arthritis Clinical Disease Activity Measures Working Group conducted a systematic review of the literature to identify RA disease activity measures. Using exclusion criteria, input from an Expert Advisory Panel (EAP), and psychometric analysis, a list of potential measures was created. A survey was administered to rheumatologists soliciting input. The WG used these survey results in conjunction with the psychometric analyses to derive final recommendations. Systematic review of the literature resulted in identification of 63 RA disease activity measures. Application of exclusion criteria and ratings by the EAP narrowed the list to 14 measures for further evaluation. Practicing rheumatologists rated 9 of these 14 measures as most useful and feasible. From these 9 measures, the WG selected 6 with the best psychometric properties for inclusion in the final set of ACR-recommended RA disease activity measures. We recommend the Clinical Disease Activity Index, Disease Activity Score with 28-joint counts (erythrocyte sedimentation rate or C-reactive protein), Patient Activity Scale (PAS), PAS-II, Routine Assessment of Patient Index Data with 3 measures, and Simplified Disease Activity Index because they are accurate reflections of disease activity; are sensitive to change; discriminate well between low, moderate, and high disease activity states; have remission criteria; and are feasible to perform in clinical settings. Copyright © 2012 by the American College of Rheumatology.

  1. Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop.

    Science.gov (United States)

    Zhang, X; Duan, J; Kesisoglou, F; Novakovic, J; Amidon, G L; Jamei, M; Lukacova, V; Eissing, T; Tsakalozou, E; Zhao, L; Lionberger, R

    2017-08-01

    On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled "Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation." The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole-body framework. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  2. Minimum recommended physical activity, and perceived barriers and benefits of exercise in methadone maintained persons.

    Science.gov (United States)

    Caviness, Celeste M; Bird, Jessica L; Anderson, Bradley J; Abrantes, Ana M; Stein, Michael D

    2013-04-01

    Methadone-maintained persons are at increased risk for many physical and mental health disorders compared to the general population. Increased physical activity could offset these risks. We assessed physical activity level, and perceived benefits and barriers to exercise in a group of 305 methadone-maintained smokers. Mean participant age was 39.9 years, 50.2% were male, 79.7% were non-Hispanic White, and mean body mass index was 29.8. Nearly 45% endorsed fair or poor physical health. Although participants perceived many benefits of exercise and few barriers, only 38% of participants met weekly recommendations for physical activity, and nearly 25% reported no physical activity. Those who met recommended guidelines were significantly more likely to endorse relapse prevention as a benefit of exercise. Motivating MMT patients to increase physical activity could have important physical, mental health, and drug treatment benefits. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Psychological, social, and environmental factors to meeting physical activity recommendations among Japanese adults

    Directory of Open Access Journals (Sweden)

    Harada Kazuhiro

    2009-08-01

    Full Text Available Abstract Background Although the benefits of the recommended level of physical activity on reducing chronic diseases are well-established, most of the Japanese population is not sufficiently active. Thus, examining correlates is an important prerequisite for designing relevant polices and effective programs. The present study investigated psychological, social, and environmental factors associated with meeting physical activity recommendations among Japanese adults. Methods Data were analyzed for 1,932 men and women (43.6 ± 13.0 years, who responded to an Internet-based cross-sectional survey. Self-reported measure of physical activity, psychological (self-efficacy, pros, and cons, social (social support, health professional advice, environmental (home fitness equipment, access to facilities, neighborhood safety, enjoyable scenery, frequently observing others exercising, residential area, and demographic (gender, age, marital status, educational level, household income level, employment status variables were obtained. Based on the current national guidelines for exercise in Japan (23 METs·hour per week, respondents were divided into two categories–recommended and not recommended (insufficient and inactive–according to their estimated weekly physical activity level. An adjusted logistic regression model was utilized. Results When adjusting for all other variables, self-efficacy (men: OR = 2.13; 95% CI: 1.55–2.94, women: OR = 2.72; 95% CI: 1.82–4.08 and possessing home fitness equipment (men: OR = 1.55; 95% CI: 1.14–2.10, women: OR = 1.41; 95% CI: 1.01–1.99 for both genders, social support (OR = 1.44; 95% CI: 1.06–1.97 for men, and enjoyable scenery (OR = 1.60; 95% CI: 1.09–2.36 for women were positively associated with attaining the recommended level of physical activity. In women, cons (OR = 0.47; 95% CI: 0.33–0.67 and living in rural areas (OR = 0.50; 95% CI: 0.25–0.97 were negatively associated with meeting the physical

  4. Psychological, social, and environmental factors to meeting physical activity recommendations among Japanese adults.

    Science.gov (United States)

    Shibata, Ai; Oka, Koichiro; Harada, Kazuhiro; Nakamura, Yoshio; Muraoka, Isao

    2009-08-28

    Although the benefits of the recommended level of physical activity on reducing chronic diseases are well-established, most of the Japanese population is not sufficiently active. Thus, examining correlates is an important prerequisite for designing relevant polices and effective programs. The present study investigated psychological, social, and environmental factors associated with meeting physical activity recommendations among Japanese adults. Data were analyzed for 1,932 men and women (43.6 +/- 13.0 years), who responded to an Internet-based cross-sectional survey. Self-reported measure of physical activity, psychological (self-efficacy, pros, and cons), social (social support, health professional advice), environmental (home fitness equipment, access to facilities, neighborhood safety, enjoyable scenery, frequently observing others exercising, residential area), and demographic (gender, age, marital status, educational level, household income level, employment status) variables were obtained. Based on the current national guidelines for exercise in Japan (23 METs.hour per week), respondents were divided into two categories-recommended and not recommended (insufficient and inactive)-according to their estimated weekly physical activity level. An adjusted logistic regression model was utilized. When adjusting for all other variables, self-efficacy (men: OR = 2.13; 95% CI: 1.55-2.94, women: OR = 2.72; 95% CI: 1.82-4.08) and possessing home fitness equipment (men: OR = 1.55; 95% CI: 1.14-2.10, women: OR = 1.41; 95% CI: 1.01-1.99) for both genders, social support (OR = 1.44; 95% CI: 1.06-1.97) for men, and enjoyable scenery (OR = 1.60; 95% CI: 1.09-2.36) for women were positively associated with attaining the recommended level of physical activity. In women, cons (OR = 0.47; 95% CI: 0.33-0.67) and living in rural areas (OR = 0.50; 95% CI: 0.25-0.97) were negatively associated with meeting the physical activity recommendations. In the psychological, social, and

  5. Feedback from physical activity monitors is not compatible with current recommendations: A recalibration study.

    Science.gov (United States)

    Thompson, Dylan; Batterham, Alan M; Peacock, Oliver J; Western, Max J; Booso, Rahuman

    2016-10-01

    Wearable devices to self-monitor physical activity have become popular with individuals and healthcare practitioners as a route to the prevention of chronic disease. It is not currently possible to reconcile feedback from these devices with activity recommendations because the guidelines refer to the amount of activity required on top of normal lifestyle activities (e.g., 150 minutes of moderate-to-vigorous intensity activity per week over-and-above normal moderate-to-vigorous lifestyle activities). The aim of this study was to recalibrate the feedback from self-monitoring. We pooled data from four studies conducted between 2006 and 2014 in patients and volunteers from the community that included both sophisticated measures of physical activity and 10-year risk for cardiovascular disease and type 2 diabetes (n=305). We determined the amount of moderate-to-vigorous intensity activity that corresponded to FAO/WHO/UNU guidance for a required PAL of 1.75 (Total Energy Expenditure/Basal Metabolic Rate). Our results show that, at the UK median PAL, total moderate-to-vigorous intensity physical activity will be around 735 minutes per week (~11% of waking time). We estimate that a 4% increase in moderate-to-vigorous intensity activity will achieve standardised guidance from FAO/WHO/UNU and will require ~1000 minutes of moderate-to-vigorous intensity activity per week. This study demonstrates that feedback from sophisticated wearable devices is incompatible with current physical activity recommendations. Without adjustment, people will erroneously form the view that they are exceeding recommendations by several fold. A more appropriate target from self-monitoring that accounts for normal moderate-to-vigorous lifestyle activities is ~1000 minutes per week, which represents ~15% of waking time. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  6. Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

    DEFF Research Database (Denmark)

    Yacobi, Avraham; Shah, Vinod P; Bashaw, Edward D

    2014-01-01

    This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic bioequivalence (BE) of dermatologic...

  7. Determinants of meeting the public health recommendations for physical activity among community-dwelling elderly Japanese.

    Science.gov (United States)

    Oka, Koichiro; Shibata, Ai

    2012-02-01

    Although regular physical activity can facilitate healthy aging, improve functional capacity, and prevent chronic diseases in the elderly, many of the Japanese elderly are not sufficiently active. Thus, examining the determinants is an important prerequisite for designing effective programs. The present study investigated the demographic, behavioral, psychosocial, and environmental determinants of meeting the national pedometer-determined physical activity recommendations for the elderly Japanese. Data were analyzed for 137 community-dwelling elderly Japanese aged 70 to 89 years (47% male, mean age = 74.5 years), who completed a questionnaire and wore a pedometer. Demographic (gender, age, marital status), behavioral (BMI, smoking, alcohol consumption), psychosocial (self-efficacy, social support, health professional advice), and environmental (perceived neighborhood environment) variables were self-reported. Averaged daily steps were obtained using 1-year pedometer measurements. Based on the national physical activity recommendations in Japan (males: 6700 steps; females: 5900 steps), the participants were divided into two categories - sufficiently active and insufficiently active. An adjusted logistic regression model was utilized. Totally, 47.4% of the participants (males: 51.5%; females: 43.8%) met the national recommendations. When adjusting for all other variables, a higher self-efficacy for exercise (AOR = 1.16; 95% CI: 1.04-1.28) and positive perception of the neighborhood environment (AOR = 1.43; 95% CI: 1.03-1.98) significantly influenced the meeting of the national recommendations. The findings clarified the need to identify effective intervention strategies to promote physical activity and suggest that an intervention design that accounts for these determinants may more effectively promote physical activity among the elderly Japanese.

  8. Complexity of intravenous iron nanoparticle formulations: implications for bioequivalence evaluation.

    Science.gov (United States)

    Pai, Amy Barton

    2017-11-01

    Intravenous iron formulations are a class of complex drugs that are commonly used to treat a wide variety of disease states associated with iron deficiency and anemia. Venofer® (iron-sucrose) is one of the most frequently used formulations, with more than 90% of dialysis patients in the United States receiving this formulation. Emerging data from global markets outside the United States, where many iron-sucrose similars or copies are available, have shown that these formulations may have safety and efficacy profiles that differ from the reference listed drug. This may be attributable to uncharacterized differences in physicochemical characteristics and/or differences in labile iron release. As bioequivalence evaluation guidance evolves, clinicians should be educated on these potential clinical issues before a switch to the generic formulation is made in the clinical setting. © 2017 New York Academy of Sciences.

  9. Active commuting reduces sociodemographic differences in adherence to recommendations derived from leisure-time physical activity among Brazilian adults.

    Science.gov (United States)

    Del Duca, G F; Nahas, M V; Garcia, L M T; Silva, S G; Hallal, P C; Peres, M A

    2016-05-01

    To investigate the consequences of including active commuting, compared with the leisure domain only, in the prevalence and sociodemographic factors associated with attending the physical activity recommendations, in Brazilian adults. Population-based cross-sectional study. Adults between 20 and 59 years of age (n = 1720) were face-to-face interviewed from September 2009 to January 2010. Sociodemographic indicators and leisure-time and commuting physical activity were assessed by a validated questionnaire. Poisson regression was used to estimate crude and adjusted prevalence ratio (PR) and 95% confidence interval (95% CI). The prevalence of adherence to recommendations when only leisure-time physical activity was considered was 15.5% (95% CI: 13.6; 17.4) and was associated with men (PR: 1.57, 95% CI: 1.25; 1.96), adults without a partner (PR: 1.38 95% CI: 1.05; 1.81) and higher educational level and income. The prevalence of adherence to physical activity recommendations after the combination of leisure-time and commuting was 29.1% (95% CI: 26.5; 31.6). Percentages differences in favor of men, white adults and those with higher educational level and income were no longer significant after the inclusion of active commuting. The inclusion of active commuting expands the percentage of adults who achieved the health-related physical activity recommendations and reduced important sociodemographic differences derived from the analysis of leisure-time physical activity alone. Public health strategies should consider the different domains of physical activity in the monitoring and promotion of a more active lifestyle. Copyright © 2016. Published by Elsevier Ltd.

  10. Recommendations for Promoting Physical Activity for Children and Adolescents in Germany. A Consensus Statement

    Directory of Open Access Journals (Sweden)

    Christine Graf

    2014-05-01

    Full Text Available Increasing physical activity and reduction of sedentary behaviour play important roles in health promotion and prevention of lifestyle-related diseases in children and adolescents. However, the question of how much physical activity is useful for which target group is still a matter of debate. International guidelines (World Health Organization; European Association for the Study of Obesity, which are mainly based on expert opinions, recommend 60 min of physical activity every day. Age- and sex-specific features and regional differences are not taken into account. Therefore, expert consensus recommendations for promoting physical activity of children and adolescents in Germany were developed with special respect to national data, but also with respect to aspects of specific target groups, e.g., children with a lower socio-economic status (SES or with migration background. They propose 90 min/day of physical activity, or at least 12,000 steps daily. Additionally, lifestyle factors, especially restriction of media consumption, were integrated. The recommendations provide orientation for parents and caregivers, for institutions such as schools and kindergartens as well as for communities and stakeholders.

  11. Recommendations for Promoting Physical Activity for Children and Adolescents in Germany. A Consensus Statement

    Science.gov (United States)

    Graf, Christine; Beneke, Ralph; Bloch, Wilhelm; Bucksch, Jens; Dordel, Sigrid; Eiser, Stefanie; Ferrari, Nina; Koch, Benjamin; Krug, Susanne; Lawrenz, Wolfgang; Manz, Kristin; Naul, Roland; Oberhoffer, Renate; Quilling, Eike; Schulz, Henry; Stemper, Theo; Stibbe, Günter; Tokarski, Walter; Völker, Klaus; Woll, Alexander

    2014-01-01

    Increasing physical activity and reduction of sedentary behaviour play important roles in health promotion and prevention of lifestyle-related diseases in children and adolescents. However, the question of how much physical activity is useful for which target group is still a matter of debate. International guidelines (World Health Organization; European Association for the Study of Obesity), which are mainly based on expert opinions, recommend 60 min of physical activity every day. Age- and sex-specific features and regional differences are not taken into account. Therefore, expert consensus recommendations for promoting physical activity of children and adolescents in Germany were developed with special respect to national data, but also with respect to aspects of specific target groups, e.g., children with a lower socio-economic status (SES) or with migration background. They propose 90 min/day of physical activity, or at least 12,000 steps daily. Additionally, lifestyle factors, especially restriction of media consumption, were integrated. The recommendations provide orientation for parents and caregivers, for institutions such as schools and kindergartens as well as for communities and stakeholders. PMID:24821136

  12. a Context-Aware Tourism Recommender System Based on a Spreading Activation Method

    Science.gov (United States)

    Bahramian, Z.; Abbaspour, R. Ali; Claramunt, C.

    2017-09-01

    Users planning a trip to a given destination often search for the most appropriate points of interest location, this being a non-straightforward task as the range of information available is very large and not very well structured. The research presented by this paper introduces a context-aware tourism recommender system that overcomes the information overload problem by providing personalized recommendations based on the user's preferences. It also incorporates contextual information to improve the recommendation process. As previous context-aware tourism recommender systems suffer from a lack of formal definition to represent contextual information and user's preferences, the proposed system is enhanced using an ontology approach. We also apply a spreading activation technique to contextualize user preferences and learn the user profile dynamically according to the user's feedback. The proposed method assigns more effect in the spreading process for nodes which their preference values are assigned directly by the user. The results show the overall performance of the proposed context-aware tourism recommender systems by an experimental application to the city of Tehran.

  13. A CONTEXT-AWARE TOURISM RECOMMENDER SYSTEM BASED ON A SPREADING ACTIVATION METHOD

    Directory of Open Access Journals (Sweden)

    Z. Bahramian

    2017-09-01

    Full Text Available Users planning a trip to a given destination often search for the most appropriate points of interest location, this being a non-straightforward task as the range of information available is very large and not very well structured. The research presented by this paper introduces a context-aware tourism recommender system that overcomes the information overload problem by providing personalized recommendations based on the user’s preferences. It also incorporates contextual information to improve the recommendation process. As previous context-aware tourism recommender systems suffer from a lack of formal definition to represent contextual information and user’s preferences, the proposed system is enhanced using an ontology approach. We also apply a spreading activation technique to contextualize user preferences and learn the user profile dynamically according to the user’s feedback. The proposed method assigns more effect in the spreading process for nodes which their preference values are assigned directly by the user. The results show the overall performance of the proposed context-aware tourism recommender systems by an experimental application to the city of Tehran.

  14. Physical activity promotion in business and industry: evidence, context, and recommendations for a national plan.

    Science.gov (United States)

    Pronk, Nicolaas P

    2009-11-01

    The contemporary workplace setting is in need of interventions that effectively promote higher levels of occupational and habitual physical activity. It is the purpose of this paper to outline an evidence-based approach to promote physical activity in the business and industry sector in support of a National Physical Activity Plan. Comprehensive literature searches identified systematic reviews, comprehensive reviews, and consensus documents on the impact of physical activity interventions in the business and industry sector. A framework for action and priority recommendations for practice and research were generated. Comprehensive, multicomponent work-site programs that include physical activity components generate significant improvements in health, reduce absenteeism and sick leave, and can generate a positive financial return. Specific evidence-based physical activity interventions are presented. Recommendations for practice include implementing comprehensive, multicomponent programs that make physical activity interventions possible, simple, rewarding and relevant in the context of a social-ecological model. The business and industry sector has significant opportunities to improve physical activity among employees, their dependents, and the community at-large and to reap important benefits related to worker health and business performance.

  15. Sedentary time, physical activity and compliance with IOM recommendations in young children at childcare.

    Science.gov (United States)

    Ellis, Yvonne G; Cliff, Dylan P; Janssen, Xanne; Jones, Rachel A; Reilly, John J; Okely, Anthony D

    2017-09-01

    The aim of this study was to report patterns of sitting, standing and physical activity (PA) and compliance with Institute of Medicine (IOM) recommendations for sedentary behavior (SB) and PA among children aged 1 to 5 years at childcare, and examine sociodemographic variations. Sitting, standing and PA time was assessed using an activPAL inclinometer over a period of 1 to 5 days in 301 children (49% boys; mean age = 3.7 ± 1.0 years) across 11 childcare services in Illawarra, NSW, Australia. Breaks and bouts of sitting and standing were calculated and categorized. Height and weight were assessed and parents completed a demographic survey. Differences by sex, age category (IOM SB and PA recommendations, respectively. Girls (odds ratio [OR]; 95%CI = 0.26; 0.13 to 0.55) and preschoolers (0.16; 0.07 to 0.38) were less likely to meet the IOM PA recommendation compared to boys and toddlers. Young children spent ~ 50% of their time at childcare sitting. Girls and preschoolers sit more and are less likely to meet PA recommendations, making them important groups to target in future interventions.

  16. Recommending scientific organization by employees as the example of their prosumer activity

    Directory of Open Access Journals (Sweden)

    Agnieszka Izabela Baruk

    2015-09-01

    Full Text Available In the article the problems related to recommending the employer by employees are presented. It is described as the example of employees’ prosumption activity. Transmitting their opinions about the organization as the employer they become the co-creators its image which is one of the key non-material marketing values. The article has theoretical-empirical character. In the theoretical part the essence of prosumption is presented. The special attention is paid to fact that in the literature this appearance is linked with consumption products not with personnel activity. In the empirical part the results of the field researches on recommending employer and its relation determinants are presented. The statistical analysis in the form of correspondence analysis method has been used to these results. It allows to estimate the dependences between analysed variables, to define the power of identified dependences, to show their character, to sort the relation determinants of recommending in the hierarchical system etc. All of the analysed dependences are significant in the statistically meaning. The stronger dependence exists in the case of vertical relation variable in the comparison to the dependence between recommending employer and horizontal relation variable. Of course each of type of organizational relations should be supported by employer because it influences on employees’ identifying with the organization which is the key determinant of the column variable.

  17. Tourist activated networks: Implications for dynamic bundling and en-route recommendations

    DEFF Research Database (Denmark)

    Zach, Florian; Gretzel, Ulrike

    2011-01-01

    This article discusses tourist-activated networks as a concept to inform technological applications supporting dynamic bundling and en route recommendations. Empirical data were collected from travelers who visited a regional destination in the US and then analyzed with respect to its network...... structure. The results indicate that the tourist-activated network for the destination is rather sparse and that there are clearly differences in core and peripheral nodes. The findings illustrate the structure of a tourist-activated network and provide implications for technology design and tourism...

  18. Therapy students' recommendations of physical activity for managing persistent low back pain in older adults.

    Science.gov (United States)

    Ryan, Cormac G; Schofield, Patricia; Martin, Denis J

    2013-07-01

    Negative views of older adults can lead to suboptimal care. For older adults with persistent low back pain (LBP), promotion of physical activity by health care professionals is important. Health care professionals' views of older adults are influenced by their training. This study aimed to compare recommendations for physical activity for managing persistent LBP offered by students in physiotherapy and occupational therapy to an older person vs. a younger person. In a cross-sectional online survey, participants (N = 77) randomly received a vignette of either a 40-yr-old or 70-yr-old patient with persistent LBP. Other than age, the vignettes were identical. There was no difference between the younger and older vignettes in the likelihood of participants making overall appropriate physical activity recommendations--63% vs. 59%, OR (95% CI) = 1.19 (0.48-2.99), p = .71--although there was a trend toward age bias on recommendations specific to daily activity. Postqualification education may be where ageist views need to be addressed.

  19. Meeting Recommended Levels of Physical Activity and Health-Related Quality of Life in Rural Adults.

    Science.gov (United States)

    Hart, Peter D

    2016-03-01

    Little is known about physical activity (PA) and health-related quality of life (HRQOL) among rural adults. The purpose of this study was to investigate the relationship between meeting recommended levels of PA and HRQOL in a rural adult population. This study analyzed data from 6,103 rural adults 18 years of age and older participating in a 2013 survey. Respondents reporting at least 150 minutes a week of moderate-intensity (or moderate-vigorous combination) PA during the past month were categorized as meeting PA guidelines. Five health variables were used to assess HRQOL. A continuous HRQOL ability score was also created using item response theory (IRT). Rural adults who met recommended levels of PA were significantly more likely to report good HRQOL in adjusted models of physical health (OR: 1.99; 95% CI: 1.54-2.56), mental health (OR: 1.96; 95% CI: 1.46-2.64), inactivity health (OR: 2.14; 95% CI: 1.54-2.97), general health (OR: 1.69; 95% CI: 1.35-2.13), and healthy days (OR: 1.98; 95% CI: 1.58-2.47), compared to those who did not meet recommended levels. Furthermore, rural adults meeting recommended levels of PA also had a significantly greater HRQOL ability score (51.7 ± 0.23, Mean ± SE), compared to those not meeting recommended levels (48.4 ± 0.33, p meeting recommended levels of PA increases the likelihood of reporting good HRQOL in rural adults. These results should be used to promote the current PA guidelines for improved HRQOL in rural populations.

  20. Sports activity after total joint arthroplasty: recommendations for the counseling physician.

    Science.gov (United States)

    Buza, John A; Fink, Leslie A; Levine, William N

    2013-02-01

    Sports activity after total joint arthroplasty (TJA) has become an increasingly important topic, as many younger patients seeking TJA have higher postoperative expectations with regard to return to athletic activity. Our current knowledge of this area is largely based on retrospective clinical studies and surveys of surgeon recommendations. The decision to participate in sports after TJA depends on the patient's general health, prior athletic experience, type of TJA, and desired sporting activity. Ultimately, patients should discuss these factors with their physician in order to make an educated decision regarding sports activity after TJA. This article summarizes the best available evidence to help guide physicians in their conversation with patients regarding safe and appropriate sports activity after TJA.

  1. Investigation of Bioequivalence Between Brand-name and Generic Irinotecan Products.

    Science.gov (United States)

    Saito, Ken-Ichi; Inoue, Yutaka; Ikegami, Yoji; Nanbo, Izumi; Onozuka, Mari; Sano, Kazumi; Yoshida, Hisahiro; Sakamoto, Toshihiro; Tatebayashi, Emi; Fujita, Ken-Ichi; Sasaki, Yasutsuna; Kitazawa, Takaki

    2016-11-01

    To investigate bioequivalence among generic and brand-name irinotecan products. Products of Yakult and Daiichi-Sankyo (brand-name products), Sandoz, Nippon Kayaku, Taiho, and Sawai were compared with respect to their composition and antitumor activity. High-performance liquid chromatography demonstrated that related substances were within the acceptable range. The 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay revealed significant differences in cytotoxicity for four cancer cell lines among the products. The concentration of the active compound SN-38 was highest in Yakult's product (23.82 ng/ml) and lowest in Daiichi-Sankyo's product (8.96 ng/ml). MTT assay data were correlated with the SN-38 concentration, suggesting that it influenced differences in cytocidal activity among products. However, the SN-38 concentration was far lower than that of irinotecan (20 mg/ml), suggesting a negligible clinical effect. Metabolism of irinotecan to SN-38 or open-ring forms did not differ significantly among the products. The generic products showed equivalent efficacy and safety to the brand-name products. Copyright© 2016 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  2. Active transportation and public transportation use to achieve physical activity recommendations? A combined GPS, accelerometer, and mobility survey study.

    Science.gov (United States)

    Chaix, Basile; Kestens, Yan; Duncan, Scott; Merrien, Claire; Thierry, Benoît; Pannier, Bruno; Brondeel, Ruben; Lewin, Antoine; Karusisi, Noëlla; Perchoux, Camille; Thomas, Frédérique; Méline, Julie

    2014-09-27

    Accurate information is lacking on the extent of transportation as a source of physical activity, on the physical activity gains from public transportation use, and on the extent to which population shifts in the use of transportation modes could increase the percentage of people reaching official physical activity recommendations. In 2012-2013, 234 participants of the RECORD GPS Study (French Paris region, median age = 58) wore a portable GPS receiver and an accelerometer for 7 consecutive days and completed a 7-day GPS-based mobility survey (participation rate = 57.1%). Information on transportation modes and accelerometry data aggregated at the trip level [number of steps taken, energy expended, moderate to vigorous physical activity (MVPA), and sedentary time] were available for 7,644 trips. Associations between transportation modes and accelerometer-derived physical activity were estimated at the trip level with multilevel linear models. Participants spent a median of 1 h 58 min per day in transportation (8.2% of total time). Thirty-eight per-cent of steps taken, 31% of energy expended, and 33% of MVPA over 7 days were attributable to transportation. Walking and biking trips but also public transportation trips with all four transit modes examined were associated with greater steps, MVPA, and energy expenditure when compared to trips by personal motorized vehicle. Two simulated scenarios, implying a shift of approximately 14% and 33% of all motorized trips to public transportation or walking, were associated with a predicted 6 point and 13 point increase in the percentage of participants achieving the current physical activity recommendation. Collecting data with GPS receivers, accelerometers, and a GPS-based electronic mobility survey of activities and transportation modes allowed us to investigate relationships between transportation modes and physical activity at the trip level. Our findings suggest that an increase in active transportation

  3. Achieving recommended daily physical activity levels through commuting by public transportation: unpacking individual and contextual influences.

    Science.gov (United States)

    Wasfi, Rania A; Ross, Nancy A; El-Geneidy, Ahmed M

    2013-09-01

    This paper estimates the amount of daily walking associated with using public transportation in a large metropolitan area and examines individual and contextual characteristics associated with walking distances. Total walking distance to and from transit was calculated from a travel diary survey for 6913 individuals. Multilevel regression modelling was used to examine the underlying factors associated with walking to public transportation. The physical activity benefits of public transportation varied along gender and socio-economic lines. Recommended minutes of daily physical activity can be achieved for public transportation users, especially train users living in affluent suburbs. Copyright © 2013 Elsevier Ltd. All rights reserved.

  4. Achievement of public health recommendations for physical activity and prevention of gains in adiposity in adults

    DEFF Research Database (Denmark)

    Grøntved, A.

    2013-01-01

    Physical activity (PA) is considered a cornerstone in weight control and public health guidelines recommend regular participation to prevent gains in adiposity. It may therefore come as a surprise that the cumulative evidence from observational studies to support this is not strong. A weakness...... of many published observational studies on this topic has been a reliance on a single baseline assessment of PA. Using only the baseline information on PA in a prospective study cause misclassification because of participants often change activity level during follow-up. In turn this causes regression...

  5. Focal Colonic FDG Activity with PET/CT: Guidelines for Recommendation of Colonoscopy

    OpenAIRE

    Liu, Tianye; Behr, Spencer; Khan, Sana; Osterhoff, Robert; Aparici, Carina Mari

    2015-01-01

    Focal 18F-fluorodeoxyglucose (FDG) colonic activity can be incidentally seen in positron emission tomography/computed tomography (PET/CT) scans. Its clinical significance is still unclear. The purpose of this study was to assess the significance of focal FDG activity in PET/CT scans by correlating the imaging findings to colonoscopy results, and come up with some guidelines for recommendation of follow-up colonoscopy. A total of 133 patients who underwent both 18F-FDG PET/CT for different onc...

  6. Bioequivalence evaluation of two brands of amoxicillin/clavulanic acid 250/125 mg combination tablets in healthy human volunteers: use of replicate design approach.

    Science.gov (United States)

    Idkaidek, Nasir M; Al-Ghazawi, Ahmad; Najib, Naji M

    2004-12-01

    The purpose of this study was to apply a replicate design approach to a bioequivalence study of amoxicillin/clavulanic acid combination following a 250/125 mg oral dose to 23 subjects, and to compare the analysis of individual bioequivalence with average bioequivalence. This was conducted as a 2-treatment 2-sequence 4-period crossover study. Average bioequivalence was shown, while the results from the individual bioequivalence approach had no success in showing bioequivalence. In conclusion, the individual bioequivalence approach is a strong statistical tool to test for intra-subject variances and also subject-by-formulation interaction variance compared with the average bioequivalence approach. copyright (c) 2004 John Wiley & Sons, Ltd.

  7. Pharmacokinetics and bioequivalence of a liquid formulation of hydroxyurea in children with sickle cell anemia.

    Science.gov (United States)

    Estepp, Jeremie H; Melloni, Chiara; Thornburg, Courtney D; Wiczling, Paweł; Rogers, Zora; Rothman, Jennifer A; Green, Nancy S; Liem, Robert; Brandow, Amanda M; Crary, Shelley E; Howard, Thomas H; Morris, Maurine H; Lewandowski, Andrew; Garg, Uttam; Jusko, William J; Neville, Kathleen A

    2016-03-01

    Hydroxyurea (HU) is a crucial therapy for children with sickle cell anemia, but its off-label use is a barrier to widespread acceptance. We found HU exposure is not significantly altered by liquid vs capsule formulation, and weight-based dosing schemes provide consistent exposure. HU is recommended for all children starting as young as 9 months of age with sickle cell anemia (SCA; HbSS and HbSβspan(0) thalassemia); however; a paucity of pediatric data exists regarding the pharmacokinetics (PK) or the exposure-response relationship of HU. This trial aimed to characterize the PK of HU in children and to evaluate and compare the bioavailability of a liquid vs capsule formulation. This multicenter; prospective; open-label trial enrolled 39 children with SCA who provided 682 plasma samples for PK analysis following administration of HU. Noncompartmental and population PK models are described. We report that liquid and capsule formulations of HU are bioequivalent; weight-based dosing schemes provide consistent drug exposure; and age-based dosing schemes are unnecessary. These data support the use of liquid HU in children unable to swallow capsules and in those whose weight precludes the use of fixed capsule formulations. Taken with existing safety and efficacy literature; these findings should encourage the use of HU across the spectrum of age and weight in children with SCA; and they should facilitate the expanded use of HU as recommended in the National Heart; Lung; and Blood Institute guidelines for individuals with SCA. © 2015, The American College of Clinical Pharmacology.

  8. RECOMMENDATIONS FOR CARDIOVASCULAR SCREENING OF ADULTS PARTICIPATING IN LEISURE-TIME SPORT ACTIVITIES

    Directory of Open Access Journals (Sweden)

    Katja Ažman Juvan

    2015-01-01

    Full Text Available Participation in regular moderate aerobic physical activity and increased physical fitness is associated with a decrease in cardiovascular mortality, which is after the age of 35 most often due to coronary events. On the other hand, moderate and vigorous physical exertion is associated with an increased risk for cardiac events, including sudden cardiac death in individuals harbouring cardiovascular disease. The risk-benefit ratio may differ in relation to the individual's age, fitness level and the presence and type of cardiovascular disease.The latest position stand of the European association of Cardiovascular Prevention and Rehabilitation on cardiovascular evaluation in middle aged/senior individuals, who are contemplating exercise or who are already engaged in nonprofessional competitive or recreational leisure sporting activity, is presented in the article. The aim of recommendations is to evaluate and encourage as many individuals as possible to participate in regular physical activity while minimizing the risk of cardiovascular adverse events. Recommendations are based on the individual's risk profile and the intended level of physical activity. Because of the large size of the population, an initial self assessment through health questionaire is proposed, relating to symptoms, risk factors for coronary artery disease and habitual exercise level. For those with positive self-assessed risk profile and those willing to perform high-intensity activities, a further risk stratification/evaluation should be performed by a qualified physician. In individuals with an increased risk for coronary events, maximal exerise is advocated and then further (cardiological evaluation when needed.

  9. Recommendations to improve physical activity among teenagers- A qualitative study with ethnic minority and European teenagers

    Directory of Open Access Journals (Sweden)

    Choudhury Sopna

    2011-05-01

    Full Text Available Abstract Background To understand the key challenges and explore recommendations from teenagers to promote physical activity with a focus on ethnic minority children. Methods Focus groups with teenagers aged 16-18 of Bangladeshi, Somali or Welsh descent attending a participating school in South Wales, UK. There were seventy four participants (18 Somali, 24 Bangladeshi and 32 Welsh children divided into 12 focus groups. Results The boys were more positive about the benefits of exercise than the girls and felt there were not enough facilities or enough opportunity for unsupervised activity. The girls felt there was a lack of support to exercise from their family. All the children felt that attitudes to activity for teenagers needed to change, so that there was more family and community support for girls to be active and for boys to have freedom to do activities they wanted without formal supervision. It was felt that older children from all ethnic backgrounds should be involved more in delivering activities and schools needs to provide more frequent and a wider range of activities. Conclusions This study takes a child-focused approach to explore how interventions should be designed to promote physical activity in youth. Interventions need to improve access to facilities but also counteract attitudes that teenagers should be studying or working and not 'hanging about' playing with friends. Thus, the value of activity for teenagers needs to be promoted not just among the teenagers but with their teachers, parents and members of the community.

  10. Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets.

    Science.gov (United States)

    Al-Tabakha, Moawia M; Fahelelbom, Khairi M S; Obaid, Dana Emad Eddin; Sayed, Sadik

    2017-05-20

    Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigate whether locally marketed amoxicillin tablets have the required chemical and physical attributes, including in vitro bioequivalence performance. Five generic products (T1, T2, T3, T4, and T5) containing combination of amoxicillin trihydrate and potassium clavulanate as 1 g strength present in immediate release tablets were compared to the reference listed drug product Augmentin® (R) for weight variation, friability, resistance to crushing, and chemical content of amoxicillin. Difference (ƒ1) and similarity (ƒ2) factors were calculated to assess in vitro bioequivalence requirements. The tablets from different products have shown compliance with the pharmacopeial requirements of the performed tests. The measured resistance to crushing of tablets did not influence the dissolution time. Three generic products released more than 85% of amoxicillin by the first 15 min as did the reference product and were considered as bioequivalent products. T1 and T4 had ƒ1 values of 16.5% and 25.4% respectively and their ƒ2 values were 44.5 and 34.6 respectively, indicating failure to meet in vitro bioequivalence requirements. Tablet formulations can play an important role in achieving bioequivalence. Independent investigations such as this study serve as an important tool to reveal possible inferior or noncompliant products that may find their way to the market.

  11. Comparison of parametric and bootstrap method in bioequivalence test.

    Science.gov (United States)

    Ahn, Byung-Jin; Yim, Dong-Seok

    2009-10-01

    The estimation of 90% parametric confidence intervals (CIs) of mean AUC and Cmax ratios in bioequivalence (BE) tests are based upon the assumption that formulation effects in log-transformed data are normally distributed. To compare the parametric CIs with those obtained from nonparametric methods we performed repeated estimation of bootstrap-resampled datasets. The AUC and Cmax values from 3 archived datasets were used. BE tests on 1,000 resampled datasets from each archived dataset were performed using SAS (Enterprise Guide Ver.3). Bootstrap nonparametric 90% CIs of formulation effects were then compared with the parametric 90% CIs of the original datasets. The 90% CIs of formulation effects estimated from the 3 archived datasets were slightly different from nonparametric 90% CIs obtained from BE tests on resampled datasets. Histograms and density curves of formulation effects obtained from resampled datasets were similar to those of normal distribution. However, in 2 of 3 resampled log (AUC) datasets, the estimates of formulation effects did not follow the Gaussian distribution. Bias-corrected and accelerated (BCa) CIs, one of the nonparametric CIs of formulation effects, shifted outside the parametric 90% CIs of the archived datasets in these 2 non-normally distributed resampled log (AUC) datasets. Currently, the 80~125% rule based upon the parametric 90% CIs is widely accepted under the assumption of normally distributed formulation effects in log-transformed data. However, nonparametric CIs may be a better choice when data do not follow this assumption.

  12. Focal Colonic FDG Activity with PET/CT: Guidelines for Recommendation of Colonoscopy

    International Nuclear Information System (INIS)

    Liu, Tianye; Behr, Spencer; Khan, Sana; Osterhoff, Robert; Aparici, Carina Mari

    2015-01-01

    Focal 18 F-fluorodeoxyglucose (FDG) colonic activity can be incidentally seen in positron emission tomography/computed tomography (PET/CT) scans. Its clinical significance is still unclear. The purpose of this study was to assess the significance of focal FDG activity in PET/CT scans by correlating the imaging findings to colonoscopy results, and come up with some guidelines for recommendation of follow-up colonoscopy. A total of 133 patients who underwent both 18 F-FDG PET/CT for different oncological indications and colonoscopy within 3 months were retrospectively studied. Imaging, colonoscopy and pathology results were analyzed. Of the 133 FDG-PET/CT scans, 109/133 (82%) did not show focal colonic FDG activity, and 24/133 (18%) did. Of the 109/133 PET/CTs without focal colonic FDG activity, 109/109 (100%) did not have evidence of colon cancer after colonoscopy and histology. Of the 24/133 PET/CTs with focal colonic FDG activity, 10/24 (42%) had pathologic confirmation of colon cancer and 14/24 (58%) did not have evidence of colon cancer after colonoscopy and histological analysis. Sensitivity was 10/10 (100%), specificity 109/123 (89%), positive predictive value (PPV) 10/24 (42%) and negative predictive value (NPV) 109/109 (100%). Incidental focal 18 FDG activity in PET/CT imaging shows a high sensitivity, specificity and NPV for malignancy, with a not so high PPV of 42%. Although some people would argue that a 42% chance of malignancy justifies colonoscopy, this maybe is not possible in all cases. However, the high sensitivity of the test does not allow these studies to be overlooked. We provide our recommendations as per when to send patients with focal FDG colonic activity to have further characterization with colonoscopy

  13. Improving nutrition and physical activity in child care: what parents recommend.

    Science.gov (United States)

    Benjamin, Sara E; Haines, Jess; Ball, Sarah C; Ward, Dianne S

    2008-11-01

    A large percentage of children in the United States spend part of their day in out-of-home child care. As rates of obesity continue to rise, especially among young children, child care has become a focus for nutrition and physical activity intervention. Parental involvement is an important component of these efforts. During summer 2006, parents of children in child care were surveyed to better understand their perceived quality of meals, snacks, and physical activity at the child-care center, and their recommendations for improvement. Parents of children who attended 94 licensed child-care centers in North Carolina were invited to complete a brief survey of perceived quality of meals, snacks, and physical activity at their centers using close-ended questions. Open-ended questions were used to identify suggestions for improvement. Five hundred eight parents from 91 child-care centers completed the questionnaire. The majority of parents reported quality of meals and snacks at the center as either excellent (30% meals, 27% snacks) or good (42% meals, 46% snacks). The main recommendations for improving meals and snacks were to increase fruits and vegetables and provide a variety of healthful foods. The majority of parents categorized the quality of physical activity at the center as excellent (36%) or good (46%), and suggested more structured, outdoor activities for children. Findings from this study provide insight into key areas of concern for parents regarding the nutrition and activity environment of child-care centers. This information may be used to create or modify interventions or policies and to help motivate parents to become advocates for change in child care.

  14. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Science.gov (United States)

    2013-08-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369... mesalamine rectal suppositories: A BE study with clinical endpoints and a fasting BE study with... suppositories: A fasting BE study with pharmacokinetic endpoints and comparative in vitro studies (melting point...

  15. 77 FR 7586 - Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray...

    Science.gov (United States)

    2012-02-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369... metered spray/sublingual products: An in vivo fasting study, an in vitro study of unit dose and uniformity... metered aerosol/sublingual products: An in vivo fasting study, an in vitro study of unit dose and...

  16. Recommended administered activities for {sup 68}Ga-labelled peptides in paediatric nuclear medicine

    Energy Technology Data Exchange (ETDEWEB)

    Machado, J.S.; Beykan, S.; Lassmann, M. [University Hospital Wuerzburg, Department of Nuclear Medicine, Wuerzburg (Germany); Herrmann, K. [University Hospital Wuerzburg, Department of Nuclear Medicine, Wuerzburg (Germany); David Geffen School of Medicine at UCLA, Department of Molecular and Medical Pharmacology, Los Angeles, CA (United States)

    2016-10-15

    The aim of this study was to establish a method for determining administered activities for {sup 68}Ga-labelled peptides. Dose calculations were based on the weight-independent effective dose model proposed by the EANM paediatric dosage card for use in paediatric nuclear medicine. Previously published time-integrated activity coefficients for {sup 68}Ga-DOTATATE, {sup 68}Ga-DOTATOC and {sup 68}Ga-pentixafor were used to calculate age-independent effective doses. Consequently, the corresponding weight-dependent effective dose coefficients were rescaled according to the formalism of the EANM dosage card to determine the radiopharmaceutical class of {sup 68}Ga-labelled peptides (''multiples'') and to calculate the baseline activities based on an upper limit for administered activity (185 MBq) in an adult. All calculated normalization factors suggest that the {sup 68}Ga-labelled peptides are class ''B'' radiopharmaceuticals. The baseline activity for all compounds is 12.8 MBq. In analogy to {sup 18}F-fluoride, we recommend a minimum activity of 14 MBq. For paediatric nuclear medicine applications involving {sup 68}Ga-labelled peptides, we suggest determining administered activities based on the formalism proposed in this work. The corresponding effective doses from these procedures will remain age-independent. (orig.)

  17. Sedentary behaviour and physical activity in South Asian women: time to review current recommendations?

    Science.gov (United States)

    Waidyatilaka, Indu; Lanerolle, Pulani; Wickremasinghe, Rajitha; Atukorala, Sunethra; Somasundaram, Noel; de Silva, Angela

    2013-01-01

    Our aims were to describe activity and sedentary behaviours in urban Asian women, with dysglycaemia (diagnosed at recruitment), and without dysglycaemia and examine the relative contribution of these parameters to their glycaemic status. 2800 urban women (30-45 years) were selected by random cluster sampling and screened for dysglycaemia for a final sample of 272 newly diagnosed, drug naive dysglycaemic and 345 normoglycaemic women. Physical activity and sedentary behaviours were assessed by the International Physical Activity Questionnaire (IPAQ). Demographic data, diet and anthropometry were recorded. Logistic regression analysis assessed contribution of all parameters to dysglycaemia and exposure attributable fractions were calculated. The mean energy expenditure on walking (2648.5±1023.7 MET-min/week) and on moderate and vigorous physical activity (4342.3±1768.1 MET-min/week) for normoglycemic women and dysglycaemic women (walking;1046.4±728.4 MET-min/week, moderate and vigorous physical activity; 1086.7±1184.4 MET-min/week) was above the recommended amount of physical activity per week. 94.3% of women spent >1000 MET-minutes/week on activity. Mean sitting and TV time for normoglycaemic and dysglycaemic women were 154.3±62.8, 38.4±31.9, 312.6±116.7 and 140.2±56.5 minutes per day respectively. Physical activity and sedentary behaviour contributed to dysglycaemia after adjustment for family history, diet, systolic blood pressure and Body Mass Index. Exposure attributable fractions for dysglycaemia were; lower physical activity: 78%, higher waist circumference: 94%, and TV viewing time: 85%. Urban South Asian women are at risk of dysglycaemia at lower levels of sedentary behaviour and greater physical activity than western populations, indicating the need for re-visiting current physical activity guidelines for South Asians.

  18. Sedentary behaviour and physical activity in South Asian women: time to review current recommendations?

    Directory of Open Access Journals (Sweden)

    Indu Waidyatilaka

    Full Text Available OBJECTIVE: Our aims were to describe activity and sedentary behaviours in urban Asian women, with dysglycaemia (diagnosed at recruitment, and without dysglycaemia and examine the relative contribution of these parameters to their glycaemic status. METHODS: 2800 urban women (30-45 years were selected by random cluster sampling and screened for dysglycaemia for a final sample of 272 newly diagnosed, drug naive dysglycaemic and 345 normoglycaemic women. Physical activity and sedentary behaviours were assessed by the International Physical Activity Questionnaire (IPAQ. Demographic data, diet and anthropometry were recorded. Logistic regression analysis assessed contribution of all parameters to dysglycaemia and exposure attributable fractions were calculated. RESULTS: The mean energy expenditure on walking (2648.5±1023.7 MET-min/week and on moderate and vigorous physical activity (4342.3±1768.1 MET-min/week for normoglycemic women and dysglycaemic women (walking;1046.4±728.4 MET-min/week, moderate and vigorous physical activity; 1086.7±1184.4 MET-min/week was above the recommended amount of physical activity per week. 94.3% of women spent >1000 MET-minutes/week on activity. Mean sitting and TV time for normoglycaemic and dysglycaemic women were 154.3±62.8, 38.4±31.9, 312.6±116.7 and 140.2±56.5 minutes per day respectively. Physical activity and sedentary behaviour contributed to dysglycaemia after adjustment for family history, diet, systolic blood pressure and Body Mass Index. Exposure attributable fractions for dysglycaemia were; lower physical activity: 78%, higher waist circumference: 94%, and TV viewing time: 85%. CONCLUSIONS: Urban South Asian women are at risk of dysglycaemia at lower levels of sedentary behaviour and greater physical activity than western populations, indicating the need for re-visiting current physical activity guidelines for South Asians.

  19. The benefits of exercise for patients with haemophilia and recommendations for safe and effective physical activity.

    Science.gov (United States)

    Negrier, C; Seuser, A; Forsyth, A; Lobet, S; Llinas, A; Rosas, M; Heijnen, L

    2013-07-01

    Most health care professionals involved in the management of people with haemophilia (PWH) believe that exercise is beneficial and its practice is widely encouraged. This article aims to demonstrate that appropriate exercise (adapted to the special needs of the individual PWH) may be beneficial for all PWH through improved physical, psychosocial and medical status. Based on evidence gathered from the literature, many PWH, particularly those using long-term prophylaxis or exhibiting a mild/moderate bleeding phenotype, are as active as their healthy peers. PWH experience the same benefits of exercise as the general population, being physically healthier than if sedentary and enjoying a higher quality of life (QoL) through social inclusion and higher self-esteem. PWH can also gain physically from increased muscle strength, joint health, balance and flexibility achieved through physiotherapy, physical activity, exercise and sport. Conversely, very little data exist on activity levels of PWH in countries with limited resources. However, regarding specific exercise recommendations in PWH, there is a lack of randomized clinical trials, and consequently formal, evidence-based guidelines have not been produced. Based on published evidence from this review of the literature, together with the clinical experience of the authors, a series of recommendations for the safe participation of PWH in regular physical activities, exercises and sport are now proposed. In summary, we believe that appropriately modified programmes can potentially allow all PWH to experience the physical and psychosocial benefits of being physically active which may ultimately lead to an improved QoL. © 2013 John Wiley & Sons Ltd.

  20. Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

    Science.gov (United States)

    Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

    2017-12-05

    The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  1. Alberta's Tomorrow Project: adherence to cancer prevention recommendations pertaining to diet, physical activity and body size.

    Science.gov (United States)

    Whelan, Heather K; Xu, Jian-Yi; Vaseghi, Sanaz; Lo Siou, Geraldine; McGregor, S Elizabeth; Robson, Paula J

    2017-05-01

    To explore cross-sectional adherence to cancer prevention recommendations by adults enrolled in a prospective cohort in Alberta, Canada. Questionnaire data were used to construct a composite cancer prevention adherence score for each participant, based on selected personal recommendations published by the World Cancer Research Fund/American Institute for Cancer Research (2007). Data were self-reported on health and lifestyle, past-year physical activity and past-year FFQ. The scores accounted for physical activity, dietary supplement use, body size, and intakes of alcohol, fruit, vegetables and red meat. Tobacco exposure was also included. Scores ranged from 0 (least adherent) to 7 (most adherent). Alberta's Tomorrow Project; a research platform based on a prospective cohort. Adult men and women (n 24 988) aged 35-69 years recruited by random digit dialling and enrolled in Alberta's Tomorrow Project between 2001 and 2009. Of the cohort, 14 % achieved adherence scores ≥5 and 60 % had scores ≤3. Overall adherence scores were higher in women (mean (sd): 3·4 (1·1)) than in men (3·0 (1·2)). The extent of overall adherence was also associated with level of education, employment status, annual household income, personal history of chronic disease, family history of chronic disease and age. Reported adherence to selected personal recommendations for cancer prevention was low in this cohort of adults. In the short to medium term, these results suggest that more work is required to identify behaviours to target with cancer prevention strategies at a population level. Future work will explore the associations between adherence scores and cancer risk in this cohort.

  2. A Pharmacokinetic Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Volunteers.

    Science.gov (United States)

    Pan, Lin; Belloni, Paula; Ding, Han Ting; Wang, Jianshuang; Rubino, Christopher M; Putnam, Wendy S

    2017-09-01

    Pirfenidone film-coated tablets were developed to offer an alternative to the marketed capsule formulation. This study assessed the bioequivalence of the tablet and capsule formulations under fed and fasted states. A Phase I, open-label, randomized, four-treatment-period, four-sequence, crossover pharmacokinetics study (NCT02525484) was conducted. Each subject received an 801-mg single dose of pirfenidone as three 267-mg capsules or one 801-mg tablet under fasted and fed conditions. Pirfenidone plasma C max , AUC 0-t and AUC 0-∞ were used to assess bioequivalence. Forty-four subjects were randomized to treatment. The 801-mg tablet in the fasted state met bioequivalence criteria [90% confidence intervals (CI) 80.00-125.00%] for the GLSM ratios of natural log-transformed C max , AUC 0-t and AUC 0-∞ . Under fed conditions, the 801-mg tablet met the bioequivalence criteria for AUC 0-t and AUC 0-∞ , but slightly exceeded the bioequivalence criteria for the C max (90% CI of 108.26-125.60%). The tablet C max was approximately 17% higher than that of the capsules. In the fed state, the tablet C max , and both AUC 0-t and AUC 0-∞ were reduced by 39% and 17%, respectively, relative to the fasted state. The tablet and capsules had acceptable tolerability profiles. The pirfenidone 801-mg tablet met bioequivalence criteria when compared with three 267-mg capsules in the fasted state. The tablet C max was slightly higher relative to capsules in the fed state, but this is not expected to have a clinically meaningful impact on the benefit-risk profile of pirfenidone. This work was supported by F. Hoffmann-La Roche Ltd.

  3. Physical activity and cancer prevention: awareness and meeting the recommendations among adult Saudis.

    Science.gov (United States)

    Amin, Tarek Tawfik; Al-Hammam, Abudllah Mohammed; AlMulhim, Nasser Abdullah; Al-Hayan, Mohammed Ibrahim; Al-Mulhim, Mona Mohammed; Al-Mosabeh, Modhahir Jawad; Al-Subaie, Mohammed Ali; Al-Hmmad, Qassem Ahmed; Al-Omran, Ahmed Adi

    2014-01-01

    There is a scarcity of information about the proportion of the adult Saudi population that meet the recommended guidelines of physical activity (PA) to reduce cancer risk. Moreover, their awareness about the role of PA in cancer prevention is unclear. This cross-sectional study aimed at estimating the proportion of adult Saudis meeting the PA guidelines, specifically those recommended by American Cancer Society (ACS) for cancer prevention, and to assess the public awareness about the role of PA in cancer prevention. Using a multistage sampling method, 2,127 adult Saudis of both genders were recruited from 6 urban and 4 rural primary health care centers in Al Hassa, Saudi Arabia. Participants were personally interviewed to gather information about their sociodemographic characteristics, searching activity about PA and cancer, and the time spent in leisure time PA (moderate and vigorous)/week using the Global Physical Activity Questionnaire with show cards. Finally, items about the role of PA in cancer risk reduction were inquired. Of the included participants, 11.6% met the recommendations for cancer prevention (≥ 45 minutes of moderate-vigorous PA activity/≥ 5 days/week or 225 minutes/week). Multivariate regression showed that being male (AOR=1.49, CI=1.09-2.06), cancer prevention. Only 11.4% of the sample indicated correctly the frequency and duration of PA required for an average adult to be physically active and while >70% of them indicated the role of PA in prevention of hypertension, coronary heart disease and lowering elevated blood cholesterol, only 18.6% and 21.7% correctly mentioned the role of PA in reducing colon and breast cancer risk, respectively. Poor knowledge was found among those with less than college education and aged ≥ 50 years. The level of knowledge was significantly positively correlated with total leisure time PA of the participants. A minority of adult Saudis in Al Hassa was aware about the role of PA in cancer prevention and

  4. Summary and recommendations of the NRC/INEL Activated Carbon Testing Program

    International Nuclear Information System (INIS)

    Scarpellino, C.D.; Sill, C.W.

    1986-01-01

    The Committee on Nuclear Air and Gas Treatment (CONAGT) of the American Society of Mechanical Engineers (ASME) sponsored an interlaboratory testing program, round-robin, of nuclear-grade activated carbon. The results of this round-robin revealed gross differences in penetration of radio-labeled methyl iodide as measured by the various laboratories when using Method A of the ASTM D-3803-79 Standard. These differences prompted the Nuclear Regulatory Commission (NRC) to establish the NRC/INEL Activated Carbon Testing Program to determine the causes of these discrepancies and to provide recommendations that could lead to an accurate and reliable testing procedure that would ensure an adequate method for assessing the capability of activated carbon to remove radioiodine from gas streams within commercial nuclear power plants. The NRC/INEL Activated Carbon Testing Program has conducted formal and informal interlaboratory comparisons to identify problems with the test method and its application and to assess the effectiveness of changes to procedures and equipment voluntarily implemented by commercial laboratories to mitigate the disparity of test results. The results of the first formal NRC/INEL Interlaboratory Comparison (IC) essentially verified the CONAGT round-robin results despite the use of a detailed test protocol. This data indicated that many of the participating laboratories probably had been operating outside the ASTM specifications for relative humidity (RH) and flow. In addition, this process provided information which was used to modify the testing protocol employed for the second NRC/INEL Interlaboratory Comparison (IC-2) to make it more rugged and reliable. These changes to the protocol together with the results of INEL sensitivity testing are the basis for the recommendations presented

  5. Supporting public health priorities: recommendations for physical education and physical activity promotion in schools.

    Science.gov (United States)

    Hills, Andrew P; Dengel, Donald R; Lubans, David R

    2015-01-01

    Physical activity (PA) provides numerous physiological and psychosocial benefits. However, lifestyle changes, including reduced PA opportunities in multiple settings, have resulted in an escalation of overweight and obesity and related health problems. Poor physical and mental health, including metabolic and cardiovascular problems is seen in progressively younger ages, and the systematic decline in school PA has contributed to this trend. Of note, the crowded school curriculum with an intense focus on academic achievement, lack of school leadership support, funding and resources, plus poor quality teaching are barriers to PA promotion in schools. The school setting and physical educators in particular, must embrace their role in public health by adopting a comprehensive school PA program. We provide an overview of key issues and challenges in the area plus best bets and recommendations for physical education and PA promotion in the school system moving forward. Copyright © 2014. Published by Elsevier Inc.

  6. 78 FR 19491 - Walking as a Way for Americans To Get the Recommended Amount of Physical Activity for Health

    Science.gov (United States)

    2013-04-01

    ...-2013-0003] Walking as a Way for Americans To Get the Recommended Amount of Physical Activity for Health...). ACTION: Request for information. SUMMARY: To address the public health problem of physical inactivity..., Physical Activity and Health Branch, Division of Nutrition, Physical Activity, and Obesity, Centers for...

  7. Current limitations and recommendations to improve testing for the environmental assessment of endocrine active substances

    Science.gov (United States)

    Coady, Katherine K.; Biever, Ronald C.; Denslow, Nancy D.; Gross, Melanie; Guiney, Patrick D.; Holbech, Henrik; Karouna-Renier, Natalie K.; Katsiadaki, Ioanna; Krueger, Hank; Levine, Steven L.; Maack, Gerd; Williams, Mike; Wolf, Jeffrey C.; Ankley, Gerald T.

    2017-01-01

    In the present study, existing regulatory frameworks and test systems for assessing potential endocrine active chemicals are described, and associated challenges are discussed, along with proposed approaches to address these challenges. Regulatory frameworks vary somewhat across geographies, but all basically evaluate whether a chemical possesses endocrine activity and whether this activity can result in adverse outcomes either to humans or to the environment. Current test systems include in silico, in vitro, and in vivo techniques focused on detecting potential endocrine activity, and in vivo tests that collect apical data to detect possible adverse effects. These test systems are currently designed to robustly assess endocrine activity and/or adverse effects in the estrogen, androgen, and thyroid hormone signaling pathways; however, there are some limitations of current test systems for evaluating endocrine hazard and risk. These limitations include a lack of certainty regarding: 1) adequately sensitive species and life stages; 2) mechanistic endpoints that are diagnostic for endocrine pathways of concern; and 3) the linkage between mechanistic responses and apical, adverse outcomes. Furthermore, some existing test methods are resource intensive with regard to time, cost, and use of animals. However, based on recent experiences, there are opportunities to improve approaches to and guidance for existing test methods and to reduce uncertainty. For example, in vitro high-throughput screening could be used to prioritize chemicals for testing and provide insights as to the most appropriate assays for characterizing hazard and risk. Other recommendations include adding endpoints for elucidating connections between mechanistic effects and adverse outcomes, identifying potentially sensitive taxa for which test methods currently do not exist, and addressing key endocrine pathways of possible concern in addition to those associated with estrogen, androgen, and thyroid

  8. Solid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycin

    KAUST Repository

    Al-Talla, Zeyad; Akrawi, Sabah H.; Emwas, Abdul-Hamid M.

    2011-01-01

    Objective: The purpose of this study was to compare the pharmacokinetic parameters and determine the bioequivalence of a generic formulation of clindamycin that is sold in the local markets in the Middle East (Clindox® 150 mg capsule; test) with a

  9. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ... exposure measures is suitable for documenting BE (e.g., transdermal delivery systems and certain rectal and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1464] Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted...

  10. Application of dermal microdialysis for the evaluation of bioequivalence of a ketoprofen topical gel

    DEFF Research Database (Denmark)

    Tettey-Amlalo, Ralph Nii Okai; Kanfer, Isadore; Skinner, Michael F

    2008-01-01

    The purpose was to investigate dermal microdialysis (DMD) for the assessment of the bioavailability of a ketoprofen topical gel formulation and to evaluate this technique as a tool for the determination of bioequivalence. Four microdialysis probes were inserted into the dermis on the volar aspect...

  11. Determination of bioequivalence of lomefloxacin tablets using urinary excretion data.

    Science.gov (United States)

    Shah, Shailesh A; Rathod, Ishwarsinh S; Savale, Shrinivas S; Patel, Dharmesh B

    2002-11-07

    The present study describes development of a sensitive and simple HPTLC method for estimation of lomefloxacin (LMF) in human urine. The drug was extracted using chloroform after adjusting the pH of urine to 7.0. Chloroform extract was spotted on silica gel 60 F(254) TLC plate and was developed in a mixture of n-butanol-methanol-ethyl acetate-6 M ammonia (4:2:3:2, v/v/v/v) as the mobile phase and scanned at 290 nm. The peak for LMF resolved at R(F) of 0.40+/-0.02. The method was validated in terms of linearity (50-600 microgram/ml), precision, specificity and accuracy. The limit of detection and limit of quantification for LMF in urine were found to be 20 and 50 microgram/ml, respectively. The average recovery of LMF from urine was 91.93%. The proposed method was applied to generate urinary excretion data for LMF after administration of two market LMF tablet formulations (400 mg, Formulation R and Formulation T) to six healthy human volunteers in a two-treatment, open, crossover design. Various pharmacokinetic parameters like peak excretion rate ((dAU/dt)(max)), time for peak excretion rate (t(max)), AUC(0-48), AUC(0- infinity ), cumulative amount and % cumulative amount of LMF excreted, elimination half-life (t(1/2)), terminal elimination rate constant (k(el)) and overall elimination rate constant (K), were calculated for both the formulations. The average cumulative amounts of LMF excreted in urine after administration of Formulation R and Formulation T were found to be 321.60 mg (80.40% of dose) and 296.51 mg (74.13% of dose), respectively. The urinary excretion profiles of LMF upto 48 h for both the formulations were found to be similar. Statistical comparison (90% confidence intervals of ratio) of various pharmacokinetic parameters of Formulation T with that of Formulation R revealed that Formulation T is bioequivalent with Formulation R.

  12. The relationship between meeting of recommendations on physical activity for health and perceived work ability among white-collar workers.

    Science.gov (United States)

    Nawrocka, Agnieszka; Garbaciak, Wiesław; Cholewa, Jarosław; Mynarski, Władysław

    2018-04-01

    The aim of this study was to evaluate the association between meeting recommendations on physical activity for health in leisure-time and the ability to work among Polish white-collar workers. The study used a cross-sectional design with a convenience sample of 360 white-collar workers. Participants recorded 7-day physical activity logs, including form, duration and intensity of leisure-time physical activities. The results were compared to health recommendations. A standardized Work Ability Index (WAI) questionnaire was used in assessing the ability to work. Participants who met health recommendations achieved higher scores of the WAI (mean score = 41.93) in comparison to those who were not sufficiently physically active (mean score = 39.35) (p health-related physical activity recommendations almost double the odds of reaching at least good work ability (OR = 1.94, 95% CI = 1.12-3.36). Meeting leisure-time physical activity recommendations (especially the criterion of vigorous physical activity) is significantly related to higher self-assessed ability to work among white-collar workers.

  13. Relationship between attainment of recommended physical activity guidelines and academic achievement: undergraduate students in Egypt.

    Science.gov (United States)

    El Ansari, Walid; Stock, Christiane

    2014-07-14

    We assessed and compared by gender, students' achievement of recommended guidelines of four PA forms, and the association between guideline achievement of each of the four PA forms and students' academic performance. Data (2009-2010) comprised 3,271 students (11 faculties) at Assiut University, Egypt. A self-administered questionnaire measured: moderate PA (MPA), vigorous PA (VPA), moderate to vigorous PA (MVPA), muscle-strengthening PA; five socio-demographic variables (gender, age, year of study, father's education, living arrangements during semester); self-rated health; and, academic performance. We compared the levels of four PA forms, socio-demographic variables, and academic performance by gender. Binary logistic regression examined the factors associated with achieving the guidelines of the four PA forms. Linear regression examined the association between frequency of four PA forms and level of academic performance. Nearly equal proportions of males and females (37%, 36%) achieved the MPA guidelines. Significantly more males achieved the VPA, MVPA, and muscle strengthening PA guidelines. Father's education was positively associated with achieving all four PA guidelines (with each increasing educational achievement of the father, student's odds of achieving PA guidelines increased by 7-9%). Students living with their parents or room mates off campus were more likely to achieve the VPA and MVPA guidelines. Students who achieved VPA and MVPA guidelines were more likely to report better academic performance. For all PA forms (except MPA), increasing academic achievement was positively associated with increasing frequency of PA, but standardised Beta (0.05-0.07) suggested a modest correlation between academic achievement and PA frequency. The linear association between frequency of PA and academic achievement, and the finding that the proportions of students who achieved the recommended levels of several forms of PA were below half of the sample call for higher

  14. People who perceive themselves as active cannot identify the intensity recommended by the international physical activity guidelines

    Directory of Open Access Journals (Sweden)

    Prokop NW

    2014-10-01

    Full Text Available Neal W Prokop,1 Travis JR Hrubeniuk,1 Martin Sénéchal,2,3 Danielle R Bouchard1,4 1Faculty of Kinesiology and Recreation Management, University of Manitoba, Winnipeg, Manitoba, Canada; 2Manitoba Institute of Child Health, Winnipeg, Manitoba, Canada; 3Department of Pediatrics and Child Health, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada; 4Health, Leisure, and Human Performance Research Institute, Winnipeg, Manitoba, Canada Background: Many national and international organizations recommend that adults achieve at least 150 minutes of aerobic physical activity (PA weekly, at a minimum moderate intensity to optimize health benefits. It is unknown if people who consider themselves as active have the ability to identify what is considered moderate intensity. Methods: Fifty-one participants who reported achieving a minimum 150 minutes per week at a minimum of moderate intensity PA were recruited through a local fitness facility. All participants underwent a single assessment involving questionnaires, clinical measures, and a treadmill test to measure the ability to perceive moderate intensity. Following the visit, participants' PA level was evaluated by heart rate monitor, while exercising, for 7 consecutive days. Results: Eighty percent of participants overestimated moderate intensity on the treadmill test; they were at vigorous intensity compared to what is considered moderate. Only 11.8% of participants accurately identified moderate intensity; all of them were women (P=0.03, had a high level of education (P=0.04, and knew that moderate intensity was the minimum intensity recommended by health organizations (P<0.01. Only 69.2% of participants reached the aerobic component of the International Physical Activity Guidelines with no significant advantage for those correctly identifying moderate intensity. Conclusion: Most people who perceive themselves as active are exercising at vigorous intensity while believing they are

  15. RECOMMENDATIONS REGARDING THE INSTITUTIONALIZATION OF MARKETING RESEARCH ACTIVITY IN ROMANIAN MICROCREDIT ORGANIZATIONS

    Directory of Open Access Journals (Sweden)

    Savescu Roxana Florenta

    2012-12-01

    Full Text Available As they mature, microcredit organizations in Romania are becoming aware of the importance of marketing in their current activities. Although marketing interventions should be considered important on all types of markets, the reality is that micro-credit companies in Romania have a limited institutional capacity to develop and implement marketing programs. This implies that marketing efforts should be focused and marketing needs should be prioritized, according to the appropriate level of market development (developing markets, growth markets and mature markets. The paper presents the results of an exploratory marketing research study regarding the marketing activity performed by microfinance institutions in Romania. The purpose of the research was to identify courses of action to institutionalize marketing research in the current activity of the subjects analyzed. It has been our intention to give a very practical dimension to the recommendations regarding the marketing information useful for microcredit organizations and categories of marketing research needing to be conducted regularly, making them applicable within the specific Romanian environment. Given the fact that on a national level scientific concerns about microfinance in Romania, in general or about marketing in the field of microfinance in particular are almost nonexistent, this thesis can be regarded as an innovation. This conclusion comes both from the investigation of existing literature and from the author's interviews with managers of microfinance institutions who have argued that this was the first time when Romanian academic institutions got interested in this sector. Potential beneficiaries of the results of this study are: managers of microcredit organizations interested in the development and sustainability of the institutions they manage; various national and international organizations interested in designing technical assistance programs in the areas identified as being

  16. Characterization of a Murine Model of Bioequivalent Bladder Wound Healing and Repair Following Subtotal Cystectomy

    Directory of Open Access Journals (Sweden)

    Mona Zarifpour

    2017-05-01

    Full Text Available Previous work demonstrated restoration of a bioequivalent bladder within 8 weeks of removing the majority of the bladder (subtotal cystectomy or STC in rats. The goal of the present study was to extend our investigations of bladder repair to the murine model, to harness the power of mouse genetics to delineate the cellular and molecular mechanisms responsible for the observed robust bladder regrowth. Female C57 black mice underwent STC, and at 4, 8, and 12 weeks post-STC, bladder repair and function were assessed via cystometry, ex vivo pharmacologic organ bath studies, and T2-weighted magnetic resonance imaging (MRI. Histology was also performed to measure bladder wall thickness. We observed a time-dependent increase in bladder capacity (BC following STC, such that 8 and 12 weeks post-STC, BC and micturition volumes were indistinguishable from those of age-matched non-STC controls and significantly higher than observed at 4 weeks. MRI studies confirmed that bladder volume was indistinguishable within 3 months (11 weeks post-STC. Additionally, bladders emptied completely at all time points studied (i.e., no increases in residual volume, consistent with functional bladder repair. At 8 and 12 weeks post-STC, there were no significant differences in bladder wall thickness or in the different components (urothelium, lamina propria, or smooth muscle layers of the bladder wall compared with age-matched control animals. The maximal contractile response to pharmacological activation and electrical field stimulation increased over time in isolated tissue strips from repaired bladders but remained lower at all time points compared with controls. We have established and validated a murine model for the study of de novo organ repair that will allow for further mechanistic studies of this phenomenon after, for example, genetic manipulation.

  17. Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies

    Directory of Open Access Journals (Sweden)

    K. O. Zupanets

    2016-03-01

    Full Text Available Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects is one of the basic principles of clinical trials (CT management. Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey. Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality. It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them. Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those

  18. Steps That Count: Physical Activity Recommendations, Brisk Walking, and Steps Per Minute-How Do They Relate?

    NARCIS (Netherlands)

    Pillay, J.; Kolbe-Alexander, T.L.; Proper, K.I.; van Mechelen, W.; Lambert, E.V.

    2014-01-01

    Background: Brisk walking is recommended as a form of health-enhancing physical activity. This study determines the steps/minute rate corresponding to self-paced brisk walking (SPBW); a predicted steps/minute rate for moderate physical activity (MPA) and a comparison of the 2 findings. Methods: A

  19. Activity of the Recommended and Optimized Rates of Pyridate on Chickpea - Mesorhizobium mediterraneum Symbiosis

    Directory of Open Access Journals (Sweden)

    Mehdi PARSA

    2014-03-01

    Full Text Available Crop-rhizobium symbiosis can be influenced by leaching of herbicides which is unavoidable after their application. Due to an adjuvant which might help to develop the low-use-rate of herbicide, an experiment was carried out to compare the impact of the recommended rate (1200 g active ingredient ha-1 and the optimized rate (282.15 g active ingredient ha-1 of pyridate on the biological properties of eight chickpea cultivars inoculated with Mesorhizobium mediterraneum, grown in pots. Based on the required rate of herbicide to give 95% control of common lambsquarters (Chenopodium album L. value, the efficacy of pyridate improved up to 3.87-fold by adding methylated rapeseed oil to spray solution. The ‘Desi’ cultivar had significantly higher nodulation than ‘Kabuli’ cultivar. In general, toxicity of the recommended rate was higher than the optimized rate. With the exception of root dry weight, all of the measured parameters were significantly affected by the recommended rate of pyridate in varying degrees. The symbiotic properties of chickpea cultivars were affected more than 10% at the recommended dose. The reduced nodulation ranged from 29% to 73% among cultivars exposed to pyridate at the recommended dose. The ‘Desi’ cultivar was more sensitive than the ‘Kabuli’ to the recommended rate of pyridate. We may conclude that effective low-use-rate of pyridate via applying of activator adjuvants should be noted.

  20. Current Perspectives on Physical Activity and Exercise Recommendations for Children and Adolescents With Autism Spectrum Disorders

    Science.gov (United States)

    Srinivasan, Sudha M.; Pescatello, Linda S.

    2014-01-01

    Recent evidence suggests that childhood obesity is increasing in children who are developing typically as well as in children with developmental disabilities such as autism spectrum disorders (ASDs). Impairments specific to autism as well as general environmental factors could lead to an imbalance between the intake and expenditure of energy, leading to obesity. In this article, we describe the mechanisms by which autism-specific impairments contribute to obesity. The evidence on exercise interventions to improve physical fitness, address obesity, and reduce autism-specific impairments in children and adolescents with ASDs is discussed. Limited evidence is currently available for exercise interventions in individuals with ASDs. Therefore, literature on other pediatric developmental disabilities and children who are developing typically was reviewed to provide recommendations for clinicians to assess physical activity levels, to promote physical fitness, and to reduce obesity in children and adolescents with ASDs. There is a clear need for further systematic research to develop sensitive assessment tools and holistic multisystem and multifactorial obesity interventions that accommodate the social communication, motor, and behavioral impairments of individuals with ASDs. PMID:24525861

  1. 21 CFR 320.26 - Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE... test product and the reference material should be administered to subjects in the fasting state, unless...

  2. Physical activity in the lifestyle of Czech university students: Meeting health recommendations

    Science.gov (United States)

    Sigmundová, Dagmar; Chmelík, František; Sigmund, Erik; Feltlová, Dana; Frömel, Karel

    2013-01-01

    The decline of physical activity (PA) in adults as well as children and youth is a worldwide phenomenon. The aim of this study is to analyse the amount of PA in Czech university students’ daily lives. The research on university students was conducted as part of nationwide research on PA in the adult population of the Czech Republic. A total of 906 students at eight selected universities were asked to participate in this study. The response rate was 79.5%. We analysed data from 641 university students: 318 male [mean age 21.63 ± 1.73; mean Body Mass Index (BMI) 23.50 ± 1.91] and 323 female (mean age 21.08 ± 1.53; mean BMI 21.23 ± 2.20). The students wore Yamax SW-701 pedometers continuously for seven days. With respect to BMI, the recommendation of 10,000 steps per day on an average day was met by 76% of men and 68% of women of normal weight, 67% of male students who were overweight or obese and 85% of female students who were overweight or obese. Of all monitored days, in both females and males, the number of steps taken on Sunday was significantly lower (p students of normal weight, students who were overweight and students who were obese on any of the monitored days. The majority of Czech male university students are of normal weight. Only 9% of students meet the criterion of 10,000 steps every day. Approximately two-thirds of students meet the 10,000 steps daily criterion on four or more days per week. The lowest number of steps is taken on Sundays; this finding supports the need for intervention programmes to enhance PA on weekends. PMID:24251753

  3. Recommendations on Physical Activity and Exercise for Older Adults Living in Long-Term Care Facilities: A Taskforce Report.

    Science.gov (United States)

    de Souto Barreto, Philipe; Morley, John E; Chodzko-Zajko, Wojtek; H Pitkala, Kaisu; Weening-Djiksterhuis, Elizabeth; Rodriguez-Mañas, Leocadio; Barbagallo, Mario; Rosendahl, Erik; Sinclair, Alan; Landi, Francesco; Izquierdo, Mikel; Vellas, Bruno; Rolland, Yves

    2016-05-01

    A taskforce, under the auspices of The International Association of Gerontology and Geriatrics-Global Aging Research Network (IAGG-GARN) and the IAGG European Region Clinical Section, composed of experts from the fields of exercise science and geriatrics, met in Toulouse, in December 2015, with the aim of establishing recommendations of physical activity and exercise for older adults living in long-term care facilities (LTCFs). Due to the high heterogeneity in terms of functional ability and cognitive function that characterizes older adults living in LTCFs, taskforce members established 2 sets of recommendations: recommendations for reducing sedentary behaviors for all LTCF residents and recommendations for defining specific, evidence-based guidelines for exercise training for subgroups of LTCF residents. To promote a successful implementation of recommendations, taskforce experts highlighted the importance of promoting residents' motivation and pleasure, the key factors that can be increased when taking into account residents' desires, preferences, beliefs, and attitudes toward physical activity and exercise. The importance of organizational factors related to LTCFs and health care systems were recognized by the experts. In conclusion, this taskforce report proposes standards for the elaboration of strategies to increase physical activity as well as to prescribe exercise programs for older adults living in LTCFs. This report should be used as a guide for professionals working in LTCF settings. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  4. Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine-active substances.

    Science.gov (United States)

    Matthiessen, Peter; Ankley, Gerald T; Biever, Ronald C; Bjerregaard, Poul; Borgert, Christopher; Brugger, Kristin; Blankinship, Amy; Chambers, Janice; Coady, Katherine K; Constantine, Lisa; Dang, Zhichao; Denslow, Nancy D; Dreier, David A; Dungey, Steve; Gray, L Earl; Gross, Melanie; Guiney, Patrick D; Hecker, Markus; Holbech, Henrik; Iguchi, Taisen; Kadlec, Sarah; Karouna-Renier, Natalie K; Katsiadaki, Ioanna; Kawashima, Yukio; Kloas, Werner; Krueger, Henry; Kumar, Anu; Lagadic, Laurent; Leopold, Annegaaike; Levine, Steven L; Maack, Gerd; Marty, Sue; Meador, James; Mihaich, Ellen; Odum, Jenny; Ortego, Lisa; Parrott, Joanne; Pickford, Daniel; Roberts, Mike; Schaefers, Christoph; Schwarz, Tamar; Solomon, Keith; Verslycke, Tim; Weltje, Lennart; Wheeler, James R; Williams, Mike; Wolf, Jeffrey C; Yamazaki, Kunihiko

    2017-03-01

    A SETAC Pellston Workshop ® "Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)" was held in February 2016 in Pensacola, Florida, USA. The primary objective of the workshop was to provide advice, based on current scientific understanding, to regulators and policy makers; the aim being to make considered, informed decisions on whether to select an ecotoxicological hazard- or a risk-based approach for regulating a given endocrine-disrupting substance (EDS) under review. The workshop additionally considered recent developments in the identification of EDS. Case studies were undertaken on 6 endocrine-active substances (EAS-not necessarily proven EDS, but substances known to interact directly with the endocrine system) that are representative of a range of perturbations of the endocrine system and considered to be data rich in relevant information at multiple biological levels of organization for 1 or more ecologically relevant taxa. The substances selected were 17α-ethinylestradiol, perchlorate, propiconazole, 17β-trenbolone, tributyltin, and vinclozolin. The 6 case studies were not comprehensive safety evaluations but provided foundations for clarifying key issues and procedures that should be considered when assessing the ecotoxicological hazards and risks of EAS and EDS. The workshop also highlighted areas of scientific uncertainty, and made specific recommendations for research and methods-development to resolve some of the identified issues. The present paper provides broad guidance for scientists in regulatory authorities, industry, and academia on issues likely to arise during the ecotoxicological hazard and risk assessment of EAS and EDS. The primary conclusion of this paper, and of the SETAC Pellston Workshop on which it is based, is that if data on environmental exposure, effects on sensitive species and life-stages, delayed effects, and effects at low concentrations are robust, initiating environmental risk

  5. Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine-active substances

    Science.gov (United States)

    Matthiessen, Peter; Ankley, Gerald T.; Biever, Ronald C.; Bjerregaard, Poul; Borgert, Christopher; Brugger, Kristin; Blankinship, Amy; Chambers, Janice; Coady, Katherine K.; Constantine, Lisa; Dang, Zhichao; Denslow, Nancy D.; Dreier, David; Dungey, Steve; Gray, L. Earl; Gross, Melanie; Guiney, Patrick D.; Hecker, Markus; Holbech, Henrik; Iguchi, Taisen; Kadlec, Sarah; Karouna-Renier, Natalie K.; Katsiadaki, Ioanna; Kawashima, Yukio; Kloas, Werner; Krueger, Henry; Kumar, Anu; Lagadic, Laurent; Leopold, Annegaaike; Levine, Steven L.; Maack, Gerd; Marty, Sue; Meador, James P.; Mihaich, Ellen; Odum, Jenny; Ortego, Lisa; Parrott, Joanne L.; Pickford, Daniel; Roberts, Mike; Schaefers, Christoph; Schwarz, Tamar; Solomon, Keith; Verslycke, Tim; Weltje, Lennart; Wheeler, James R.; Williams, Mike; Wolf, Jeffery C.; Yamazaki, Kunihiko

    2017-01-01

    A SETAC Pellston Workshop® “Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)” was held in February 2016 in Pensacola, Florida, USA. The primary objective of the workshop was to provide advice, based on current scientific understanding, to regulators and policy makers; the aim being to make considered, informed decisions on whether to select an ecotoxicological hazard- or a risk-based approach for regulating a given endocrine-disrupting substance (EDS) under review. The workshop additionally considered recent developments in the identification of EDS. Case studies were undertaken on 6 endocrine-active substances (EAS—not necessarily proven EDS, but substances known to interact directly with the endocrine system) that are representative of a range of perturbations of the endocrine system and considered to be data rich in relevant information at multiple biological levels of organization for 1 or more ecologically relevant taxa. The substances selected were 17α-ethinylestradiol, perchlorate, propiconazole, 17β-trenbolone, tributyltin, and vinclozolin. The 6 case studies were not comprehensive safety evaluations but provided foundations for clarifying key issues and procedures that should be considered when assessing the ecotoxicological hazards and risks of EAS and EDS. The workshop also highlighted areas of scientific uncertainty, and made specific recommendations for research and methods-development to resolve some of the identified issues. The present paper provides broad guidance for scientists in regulatory authorities, industry, and academia on issues likely to arise during the ecotoxicological hazard and risk assessment of EAS and EDS. The primary conclusion of this paper, and of the SETAC Pellston Workshop on which it is based, is that if data on environmental exposure, effects on sensitive species and life-stages, delayed effects, and effects at low concentrations are robust, initiating environmental risk

  6. Adherence to diet, physical activity and body weight recommendations and breast cancer incidence in the Black Women's Health Study.

    Science.gov (United States)

    Nomura, Sarah J O; Dash, Chiranjeev; Rosenberg, Lynn; Yu, Jeffrey; Palmer, Julie R; Adams-Campbell, Lucile L

    2016-12-15

    Adherence to cancer prevention recommendations has been associated with lower incidence of breast cancer in previous studies, but evidence in African American women is limited. This project evaluated the association between adherence to the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) cancer prevention recommendations and breast cancer incidence among African American women. The Black Women's Health Study (analytic cohort = 49,103) is an ongoing prospective cohort study of African American women, ages 21-69 years at baseline (1995). Adherence scores for seven WCRF/AICR recommendations (adherent = 1, partial adherence = 0.5, non-adherence = 0) were calculated using questionnaire data and summed for overall (maximum = 7) and diet only (maximum = 5) scores. Associations between baseline and time-varying adherence scores and breast cancer incidence (N = 1,827 incident cases through 2011) were evaluated using proportional hazards regression. In this cohort, 8.5% adhered >4 recommendations. Adherence at baseline was not associated with breast cancer incidence. Higher overall time-varying adherence (per 0.5 point increase) was associated with lower breast cancer incidence (HR: 0.90, 95% CI: 0.84-0.96). Adherence to physical activity, sugar beverage and red and processed meat recommendations were also associated with reduced risk. Adherence to the WCRF/AICR recommendations was low and may be associated with lower breast cancer incidence in African American women. © 2016 UICC.

  7. Pharmacokinetic and bioequivalence studies of immediate release diclofenac potassium tablets (50mg) in healthy volunteers.

    Science.gov (United States)

    Ali, Huma; Shoaib, Muhammad Harris; Zafar, Farya; Hanif, Muhammad; Bushra, Rabia; Naz, Asia; Khursheed, Raheela

    2016-09-01

    This study was conducted with the aim to determine the pharmacokinetic and bioequivalence of diclofenac potassium 50 mg test (F4) tablet formulation with reference product (Caflam). Present study was single dose, randomized, two phase cross over design, conducted in 12 healthy Pakistani volunteers and planned in accordance with FDA guidelines. In this study a simple, selective, sensitive and reproducible HPLC procedure was developed and validated for the estimation of diclofenac potassium in plasma. The process was validated in the range of 50 - 0.05 µg.mL-1 and used in bioequivalence trial of two products. Multiple blood samples were collected at various time points (0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 14 hr after treating volunteers with test (F4) and marketed reference brand. Plasma separation and deproteination were carried out with acetonitrile; samples (20µL) were injected using the validated HPLC method. Various pharmacokinetic parameters (compartmental and noncompartmental) were estimated using KineticaTM 4.4.1 (Thermo Electron Corp. USA). Bioequivalence among the products was established by calculating the 90% CI with log and non log transformed data for Cmaxcalc, Tmaxcalc, AUC0-∞, AUCtot and AUClast using two way ANOVA and Schirmann's Two one sided t- test. No significant difference was found between log and non-log data. The 90% confidence interval values using log transformed data for AUC0-∞ (0.997-1.024), AUCtot (1.004-1.031), AUClast (0.997 -1.024), Cmaxcalc (0.994-1.007) and Tmaxcalc (0.996-1.013) for the trial and reference products were found within the FDA acceptable limits of 0.8-1.25. Results were further verified by the Schirmann's one-sided t test. Results showed the bioequivalence of test and reference formulations. Both the products were well tolerated.

  8. Consumer's risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs.

    Science.gov (United States)

    Muñoz, Joel; Alcaide, Daniel; Ocaña, Jordi

    2016-05-30

    The 2010 US Food and Drug Administration and European Medicines Agency regulatory approaches to establish bioequivalence in highly variable drugs are both based on linearly scaling the bioequivalence limits, both take a 'scaled average bioequivalence' approach. The present paper corroborates previous work suggesting that none of them adequately controls type I error or consumer's risk, so they result in invalid test procedures in the neighbourhood of a within-subject coefficient of variation osf 30% for the reference (R) formulation. The problem is particularly serious in the US Food and Drug Administration regulation, but it is also appreciable in the European Medicines Agency one. For the partially replicated TRR/RTR/RRT and the replicated TRTR/RTRT crossover designs, we quantify these type I error problems by means of a simulation study, discuss their possible causes and propose straightforward improvements on both regulatory procedures that improve their type I error control while maintaining an adequate power. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  9. Piroxicam immediate release formulations: A fasting randomized open-label crossover bioequivalence study in healthy volunteers.

    Science.gov (United States)

    Helmy, Sally A; El-Bedaiwy, Heba M

    2014-11-01

    Piroxicam is a NSAID with analgesic and antipyretic properties, used for the treatment of rheumatoid diseases. The aim of this study was to evaluate the bioequivalence of two brands of piroxicam capsules (20 mg) in 24 Egyptian volunteers. The in vivo study was established according to a single-center, randomized, single-dose, laboratory-blinded, 2-period, 2-sequence, crossover study with a washout period of 3 weeks. Under fasting conditions, 24 healthy male volunteers were randomly selected to receive a single oral dose of one capsule (20 mg) of either test or reference product. Plasma samples were obtained over a 144-hour interval and analyzed for piroxicam by HPLC with UV detection. The pharmacokinetic parameters Cmax , tmax , AUC0-t , AUC0-∞ , Vd /F, Cl/F, and t1/2 were determined from plasma concentration-time profiles. The 90% confidence intervals for the ratio of log transformed values of Cmax , AUC0-t , and AUC0-∞ of the two treatments were within the acceptable range (0.8-1.25) for bioequivalence. From PK perspectives, the two piroxicam formulations were considered bioequivalent, based on the rate and extent of absorption. No adverse events occurred or were reported after a single 20-mg piroxicam and both formulations were well-tolerated. © 2014, The American College of Clinical Pharmacology.

  10. Validation of the NPAQ-short - a brief questionnaire to monitor physical activity and compliance with the WHO recommendations

    DEFF Research Database (Denmark)

    Danquah, Ida Høgstedt; Petersen, Christina Bjørk; Skov, Sofie Smedegaard

    2018-01-01

    BACKGROUND: Using self-reported surveys to monitor physical activity levels in the population require short items covering both time and intensity. The present study aims to 1) develop the Nordic Physical Activity Questionnaire-short from the original version of the NPAQ, 2) assess test...... when using both open and closed-ended questions. However, using open-ended questions seems to be a better answering mode for self-reported surveys monitoring WHO's physical activity recommendations.......-retest reliability and criterion validity of the NPAQ-short, and 3) test the NPAQ-short's ability to monitor compliance with the WHO recommendations on physical activity. In addition, we aimed to compare open and closed-ended answering modes for the NPAQ-short. METHODS: A sample of 122 participants were included...

  11. Walking, biking or sport: how Spanish women attending breast cancer screening meet physical activity recommendations?

    Science.gov (United States)

    Peiró-Pérez, Rosana; Salas, Dolores; Vallés, Guillermo; Abad-Fernandez, Ma Soledad; Vidal, Carmen; Sanchez-Contador Escudero, Carmen; Ascunce-Elizaga, Nieves; Zubizarreta, Raquel; Pedraz, Carmen; Pérez-Gómez, Beatriz; Navarrete-Muñoz, Eva María; Vioque, Jesús; Pollán, Marina

    2015-10-01

    The aim is to analyse physical activity (PA), the fulfillment recommendation of at least 150 min of moderate PA, through walking/biking (W&B), sport, both types of PA and the factors associated with inactivity by Spanish women who attended breast cancer screening programmes. The DDM-Spain is a multicentre cross-sectional study involving 3584 women, aged 45-68, attending screening in seven Spanish cities. Data were collected using a questionnaire, including age, socio-demographic and lifestyle characteristics, family burden and PA. PA was converted into metabolic equivalent of task (METs), categorized as low ≤ 600 METs min per week (m/w), moderate 600-3000 METs m/w and high ≥ 3000 METs m/w. A multivariate logistic regression was performed to identify variables associated with inactivity for each type of PA. No women achieved a high level of PA through sport. 79.2% achieved a high or moderate level of PA by W&B. Lack of sport was associated with being overweight (odds ratio OR = 1.31; 95% confidence interval CI: 1.06 to 1.62), body mass index (BMI) ≥ 30 (OR = 1.85; 95% CI: 1.44 to 2.38), smoking (OR = 1.56; 95% CI: 1.22 to 2.00) and living with a disabled person (OR = 1.64; 95% CI: 1.0 to 2.81), whereas enough sport practice was associated with higher educational or socio-economic level (SEL). Regarding W&B, inactivity was associated with BMI ≥ 30 (OR = 1.91; 95% CI: 1.49 to 2.45) and living with someone >74 (OR = 1.96; 95% CI: 1.48 to 2.58). Inactivity for both types of exercise was associated with a BMI ≥ 30 (OR = 2.13; 95% CI: 1.63 to 2.8), smoking (OR = 1.41; 95% CI: 1.09 to 1.81) and living with someone >74 (OR = 1.69; 95% CI: 1.24 to 2.28). Family burden and BMI ≥ 30 are inversely associated with both types of PA. W&B is the most common type of PA regardless of educational and SEL. © The Author 2015. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

  12. Cardiorespiratory fitness and adiposity in breast cancer survivors: is meeting current physical activity recommendations really enough?

    Science.gov (United States)

    Santos-Lozano, Alejandro; Ramos, Javier; Alvarez-Bustos, Alejandro; Cantos, Blanca; Alejo, Lidia B; Pagola, Itziar; Soria, Ana; Maximiano, Constanza; Fiuza-Luces, Carmen; Soares-Miranda, Luisa; Lucia, Alejandro; Ruiz-Casado, Ana

    2018-02-05

    Breast cancer (BC) survivors are becoming increasingly predisposed to cardiovascular disease (CVD) mortality. Low cardiorespiratory fitness and physical activity (PA) levels, as well as high values of adiposity indices, contribute to CVD risk. We evaluated adiposity, cardiorespiratory profile, and PA levels in two independent cohorts of BC survivors. Data were collected from two groups (99% women) from different areas of Madrid (Spain): group 1, n = 110, age 51.4 ± 9.7 years, median time from diagnosis 365 days (95% confidence interval [CI], 354-401), and group 2, n = 93, age 54.7 ± 8.9 years, 1714 days (95% CI, 1502-1938). We estimated peak oxygen uptake (VO 2peak ) and measured body mass index (BMI), waist circumference (WC), waist-to-hip index, and accelerometry-determined PA. Both groups had values of BMI in the overweight range (25.3 ± 4.3 and 27.1 ± 5.1 kg/m 2 , p = 0.003). Estimated VO 2peak levels were lower in group 2 than in group 1 (28.1 ± 9.1 and 23.7 ± 8.8 ml/kg/min, p < 0.001), although levels in both groups were low. Yet, the majority of participants in both groups (81 and 88%, p = 0.234) met international PA recommendations (235 ± 196 and 351 ± 173 min/week of moderate-vigorous PA, p < 0.001). Both groups had very low levels of vigorous PA. These results were essentially independent of type of treatment (anthracycline/radiotherapy). We found a poor cardiorespiratory profile in two independent BC cohorts that differed in median time from diagnosis (as well in socioeconomic status), supporting the notion that implementation of PA (possibly focusing on vigorous PA) and dietary intervention is urgently needed in this patient population.

  13. Application of the Commission’s recommendations: the activities of ICRP Committee 4

    International Nuclear Information System (INIS)

    Lochard, Jacques

    2012-01-01

    Committee 4 of the International Commission on Radiological Protection (ICRP) is responsible for developing principles, recommendations, and guidance on the protection of man against radiation exposure; and considering their practical application in all exposure situations. The Committee also acts as a major point of contact between ICRP and other international organisations and professional bodies concerned with protection against ionising radiation. The current work of the Committee involves the development of a series of reports on implementation of the 2007 Recommendations, and a reflection on the ethical foundations of the radiological protection system. Following the accident in Fukushima, Committee 4 also initiated an analysis of management of the consequences of the accident, with the objective of revising, if necessary, the Commission’s publications on emergency and post-accident situations.

  14. The Daily Movement Pattern and Fulfilment of Physical Activity Recommendations in Swedish Middle-Aged Adults: The SCAPIS Pilot Study.

    Directory of Open Access Journals (Sweden)

    Elin Ekblom-Bak

    Full Text Available Different aspects of the daily movement pattern--sitting, light intensity physical activity, and moderate- and vigorous intensity physical activity--have each independently been associated with health and longevity. Previous knowledge of the amount and distribution of these aspects in the general Swedish population, as well as the fulfilment rate of physical activity recommendations, mainly relies on self-reported data. More detailed data assessed with objective methods is needed. The aim of the study was to present descriptive data on the daily movement pattern in a middle-aged Swedish population assessed by hip-worn accelerometers. The cohort consisted of 948 participants (51% women, aged 50 to 64 years, from the Swedish CArdioPulmonary bioImage pilot Study. In the total sample, 60.5% of accelerometer wear time was spent sitting, 35.2% in light physical activity and 3.9% in moderate- and vigorous physical activity. Men and participants with high educational level spent a larger proportion of time sitting, compared to women and participants with low educational level. Men and participants with a high educational level spent more time, and the oldest age-group spent less time, in moderate- and vigorous physical activity. Only 7.1% of the study population met the current national physical activity recommendations, with no gender, age or education level differences. Assessment of all three components of the daily movement pattern is of high clinical relevance and should be included in future research. As the fulfilment of national physical activity recommendations is very low and sitting time is very high in our middle-aged population, the great challenge remains to enhance the implementation of methods to increase the level of physical activity in this population.

  15. Identifying environmental, social, and psychological correlates of meeting the recommended physical activity levels for colon cancer prevention among Japanese adults.

    Science.gov (United States)

    Ishii, Kaori; Shibata, Ai; Oka, Koichiro

    2013-11-01

    Although physical activity reduces the risk of diseases such as cancer, diabetes and cardiovascular disease, a large proportion of the population is not sufficiently physically active. Therefore, the present study examined the environmental, social, and psychological correlates for meeting the 2 recommended physical activity criteria: ≥420 min per week of at least moderate-intensity activity (MPA criterion) and ≥210 min per week of vigorous activity (VPA criterion) for colon cancer prevention among Japanese adults. Cross-sectional study. The sample included 2000 Japanese adults aged 20-79 years. An Internet-based survey was used to assess seven sociodemographic variables (e.g., education level, employment status), environmental variables (home fitness equipment, access to facilities, neighborhood safety, aesthetic sensibilities, and frequency of observing others exercising, residential area), social variables (social support), psychological variables (self-efficacy, perceived positive (pros) and negative (cons) aspects of exercise), and physical activity. The adjusted odds of meeting each physical activity criterion by these variables were calculated. Overall, 22.3% of the study population met the criterion of MPA, and 7.3% met the criterion of VPA. Having high self-efficacy, fewer perceived cons, possessing home fitness equipment, reporting enjoyable scenery, and living in a rural area were significantly associated with meeting the recommended criteria. Participants who met the 2 activity recommendations differed by self-efficacy, cons, possession of home fitness equipment, reporting of enjoyable scenery, and residential area. These findings imply that strategies to promote more intense physical activities specifically in terms of these variables may be necessary for colon cancer prevention. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

  16. Sedentary time, physical activity and compliance with IOM recommendations in young children at childcare

    Directory of Open Access Journals (Sweden)

    Yvonne G. Ellis

    2017-09-01

    Children spent 48.4% of their time at childcare sitting, 32.5% standing, and 19.1% in PA. Boys spent significantly more time in PA compared to girls (20.8% vs 17.7%; P = 0.003. Toddlers (<3 years spent significantly more time in PA compared to preschoolers (≥3 years (22.2% vs 18.3%; P < 0.001. Children who were underweight spent significantly more time sitting compared with their overweight peers (52.4% vs 46.8%; P = 0.003. 56% and 16% of children met the IOM SB and PA recommendations, respectively. Girls (odds ratio [OR]; 95%CI = 0.26; 0.13 to 0.55 and preschoolers (0.16; 0.07 to 0.38 were less likely to meet the IOM PA recommendation compared to boys and toddlers. Young children spent ~50% of their time at childcare sitting. Girls and preschoolers sit more and are less likely to meet PA recommendations, making them important groups to target in future interventions.

  17. Recommendations for participation in competitive sport and leisure-time physical activity in individuals with cardiomyopathies, myocarditis and pericarditis.

    Science.gov (United States)

    Pelliccia, Antonio; Corrado, Domenico; Bjørnstad, Hans Halvor; Panhuyzen-Goedkoop, Nicole; Urhausen, Axel; Carre, Francois; Anastasakis, Aris; Vanhees, Luc; Arbustini, Eloisa; Priori, Silvia

    2006-12-01

    Several relatively uncommon, but important cardiovascular diseases are associated with increased risk for acute cardiac events during exercise (including sudden death), such as hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC) and myo-pericarditis. Practising cardiologists are frequently asked to advise on exercise programmes and sport participation in young individuals with these cardiovascular diseases. Indeed, many asymptomatic (or mildly symptomatic) patients with cardiomyopathies aspire to a physically active lifestyle to take advantage of the many documented benefits of exercise. While recommendations dictating the participation in competitive sport for athletes with cardiomyopathies and myo-pericarditis have recently been published as a consensus document of the European Society of Cardiology, no European guidelines have addressed the possible participation of patients with cardiomyopathies in recreational and amateur sport activities. The present document is intended to offer a comprehensive overview to practising cardiologists and sport physicians of the recommendations governing safe participation in different types of competitive sport, as well as the participation in a variety of recreational physical activities and amateur sports in individuals with cardiomyopathies and myo-pericarditis. These recommendations, based largely on the experience and insights of the expert panel appointed by the European Society of Cardiology, include the most up-to-date information concerning regular exercise and sports activity in patients with cardiomyopathies and myo-pericarditis.

  18. Adherence to physical activity recommendations and physical and mental health risk in people with severe mental illness in Uganda.

    Science.gov (United States)

    Vancampfort, Davy; Probst, Michel; Basangwa, David; De Hert, Marc; Myin-Germeys, Inez; van Winkel, Ruud; Ward, Philip B; Rosenbaum, Simon; Mugisha, James

    2017-11-29

    This study investigated cardio-metabolic risk factors among patients with severe mental illness who do or do not meet the recommendations of 150min per week of physical activity. A secondary aim was to assess whether those that do meet the recommendations report lower levels of mental health symptoms. 107 (60♀) Ugandan in- and outpatients (mean age=34.4 ± 9.7 years) with severe mental illness (depression=7, bipolar disorder=55, schizophrenia=45) completed the Physical Activity Vital Sign (PAVS) method and Brief Symptoms Inventory -18. Participants were also screened for abdominal obesity (waist circumference>90cm), overweight (body mass index≥25) and hypertension (systolic pressure≥140mmHg and/or diastolic pressure≥90mmHg).48.6% (n = 52) of patients met the physical activity recommendations as assessed by the PAVS method. 41.1% (n = 44) were overweight, 40.2% (n = 43) had abdominal obesity and 23.4% (n = 25) had hypertension. Those who did not meet the physical activity recommendations were significantly older, had a higher BSI-18 somatisation score, and had a higher risk of overweight [relative risk (RR) = 2.88, 95% confidence interval (CI) = 1.59-4.99], abdominal obesity (RR = 1.82, 95%CI = 1.13-2.93), and hypertension (RR = 2.16, 95%CI = 0.99-4.73). The PAVS is a feasible method of assessing physical activity among patients with severe mental illness in a low resource setting. The PAVS may have clinical utility for physical and mental health risk stratification. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Suppliers' activities within the controlled zones of licensees handling ionizing radiation sources. Recommendations

    International Nuclear Information System (INIS)

    1999-01-01

    The Recommendations are intended to lay down a unified procedure for preparing licence applications related to ionizing radiation source handling, including the required documentation. The guidelines were set up based on documents of the Dukovany nuclear power plant and adapted to serve the Temelin nuclear power plant and other workplaces handling ionizing radiation sources as well. Selected provisions of applicable legislation are reproduced, and responsibilities are described. The major part of the publication is constituted by model documents, particularly a model Quality Assurance Programme. (P.A.)

  20. Effects of Juvenile Idiopathic Arthritis on Kinematics and Kinetics of the Lower Extremities Call for Consequences in Physical Activities Recommendations

    OpenAIRE

    Hartmann, M.; Kreuzpointner, F.; Haefner, R.; Michels, H.; Schwirtz, A.; Haas, J. P.

    2010-01-01

    Juvenile idiopathic arthritis (JIA) patients (n = 36) with symmetrical polyarticular joint involvement of the lower extremities and healthy controls (n = 20) were compared concerning differences in kinematic, kinetic, and spatio-temporal parameters with 3D gait analysis. The aims of this study were to quantify the differences in gait between JIA patients and healthy controls and to provide data for more detailed sport activities recommendations. JIA-patients showed reduced walking speed and s...

  1. Preoperative predictors of adherence to dietary and physical activity recommendations and weight loss one year after surgery.

    Science.gov (United States)

    Bergh, Irmelin; Lundin Kvalem, Ingela; Risstad, Hilde; Sniehotta, Falko F

    2016-05-01

    Weight loss and weight loss maintenance vary considerably between patients after bariatric surgery. Postoperative weight gain has partially been explained by lack of adherence to postoperative dietary and physical activity recommendations. However, little is known about factors related to postoperative adherence. The aim of this study was to examine psychological, behavioral, and demographic predictors of adherence to behavior recommendations and weight loss 1 year after bariatric surgery. Oslo University Hospital. In a prospective cohort study, 230 patients who underwent Roux-en-Y gastric bypass were recruited from Oslo University hospital from 2011 to 2013. They completed a comprehensive questionnaire before and 1 year after surgery. Weight was measured preoperatively, on the day of surgery, and 1-year postoperatively. Mean body mass index was 44.9 kg/m(2) (standard deviation [SD] = 6.0) preoperatively and 30.6 kg/m(2) (SD = 5.2) 1 year after surgery. Patients lost on average 29.2 % (SD = 8.2) of their initial weight. Predictors of dietary adherence were years with dieting experience, readiness to limit food intake, and night eating tendency. Preoperative physical activity and planning predicted postoperative physical activity whereas predictors of weight loss were higher frequency of snacking preoperatively, greater past weight loss, and lower age. Several preoperative psychological predictors were related to postoperative adherence to dietary and physical activity recommendations but were not associated with weight loss. Interventions targeting psychological factors facilitating behavior change during the initial postoperative phase are recommended as this might improve long-term outcomes. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  2. Guidelines on Active Content and Mobile Code: Recommendations of the National Institute of Standards and Technology

    National Research Council Canada - National Science Library

    Jansen, Wayne

    2001-01-01

    .... One such category of technologies is active content. Broadly speaking, active content refers to electronic documents that, unlike past character documents based on the American Standard Code for Information Interchange (ASCII...

  3. Physical Activity and Pregnancy: Past and Present Evidence and Future Recommendations

    Science.gov (United States)

    Symons Downs, Danielle; Chasan-Taber, Lisa; Evenson, Kelly R.; Leiferman, Jenn; Yeo, SeonAe

    2012-01-01

    Purpose: In this review, we provide researchers and practitioners with an overview of the physical activity and pregnancy literature to promote prenatal physical activity, improve measurement, further elucidate the role of activity in reducing maternal health complications, and inform future research. Method: We examined past and present physical…

  4. Comprehensive School Physical Activity Programs: Recommendations for Physical Education Teacher Education

    Science.gov (United States)

    Zhang, Xiaoxia; Gu, Xiangli; Zhang, Tao; Keller, Jean; Chen, Senlin

    2018-01-01

    Comprehensive school physical activity programs (CSPAPs) aim to promote physical activity and healthy lifestyles among school-age children and adolescents. Physical educators are highly qualified individuals taking on the role of certified physical activity leaders. Physical education teacher education (PETE) programs should consider preparing…

  5. Panel: Current Status of Knowledge and Recommendations for Further Related Activities

    International Nuclear Information System (INIS)

    Caldarola, L.; Costa, J.; Fauske, Hans K.; Jakeman, D.; Mizuta, H.; Wright, R.W.; Stadie, K.B.

    1976-01-01

    This Panel consists of two parts, in the first part the participants attempt to summarise their views on the current status and knowledge of SFI and its importance for the LMFBR safety case and in the second part they try to agree on recommendations for future actions. The first question tackled was: what progress has been made since the Ispra meeting which was a little over two years ago - in answering the question: 'what role does SFI play in LMFBR safety'? The second question approached was: 'Is it possible to identify SFI areas which are not yet covered by the present research and development programme? Finally 4 recommendations were proposed: 1. to have another meeting of the same nature as this one and the previous ones in two years' time; 2. to create a group dealing with the fundamental science with a view to further the safety of the LMFBR. This group would meet more regularly and would not require, and that is the important thing, approval from-CSNI every time it meets; 3. to discontinue the group on calculational models; 4. to publish at least one to two newsletters between this SFI meeting and the next SFI meeting in two years

  6. Entrustable Professional Activities for Pathology: Recommendations From the College of American Pathologists Graduate Medical Education Committee.

    Science.gov (United States)

    McCloskey, Cindy B; Domen, Ronald E; Conran, Richard M; Hoffman, Robert D; Post, Miriam D; Brissette, Mark D; Gratzinger, Dita A; Raciti, Patricia M; Cohen, David A; Roberts, Cory A; Rojiani, Amyn M; Kong, Christina S; Peterson, Jo Elle G; Johnson, Kristen; Plath, Sue; Powell, Suzanne Zein-Eldin

    2017-01-01

    Competency-based medical education has evolved over the past decades to include the Accreditation Council for Graduate Medical Education Accreditation System of resident evaluation based on the Milestones project. Entrustable professional activities represent another means to determine learner proficiency and evaluate educational outcomes in the workplace and training environment. The objective of this project was to develop entrustable professional activities for pathology graduate medical education encompassing primary anatomic and clinical pathology residency training. The Graduate Medical Education Committee of the College of American Pathologists met over the course of 2 years to identify and define entrustable professional activities for pathology graduate medical education. Nineteen entrustable professional activities were developed, including 7 for anatomic pathology, 4 for clinical pathology, and 8 that apply to both disciplines with 5 of these concerning laboratory management. The content defined for each entrustable professional activity includes the entrustable professional activity title, a description of the knowledge and skills required for competent performance, mapping to relevant Accreditation Council for Graduate Medical Education Milestone subcompetencies, and general assessment methods. Many critical activities that define the practice of pathology fit well within the entrustable professional activity model. The entrustable professional activities outlined by the Graduate Medical Education Committee are meant to provide an initial framework for the development of entrustable professional activity-related assessment and curricular tools for pathology residency training.

  7. Integration of in vitro biorelevant dissolution and in silico PBPK model of carvedilol to predict bioequivalence of oral drug products.

    Science.gov (United States)

    Ibarra, Manuel; Valiante, Cristian; Sopeña, Patricia; Schiavo, Alejandra; Lorier, Marianela; Vázquez, Marta; Fagiolino, Pietro

    2018-06-15

    Bioequivalence implementation in developing countries where a high proportion of similar drug products are being marketed has found several obstacles, impeding regulatory agencies to move forward with this policy. Biopharmaceutical quality of these products, several of which are massively prescribed, remains unknown. In this context, an in vitro-in silico-in vivo approach is proposed as a mean to screen product performance and target specific formulations for bioequivalence assessment. By coupling in vitro biorelevant dissolution testing in USP-4 Apparatus (flow-through cell) with physiologically-based pharmacokinetic (PBPK) modeling in PK-Sim® software (Bayer, Germany), the performance of seven similar products of carvedilol tablets containing 25 mg available in the Uruguayan market were compared with the brand-name drug Dilatrend®. In silico simulations for Dilatrend® were compared with published results of bioequivalence studies performed in fasting conditions allowing model development through a learning and confirming process. Single-dose pharmacokinetic profiles were then simulated for the brand-name drug and two similar drug products selected according to in vitro observations, in a virtual Caucasian population of 1000 subjects (50% male, aged between 18 and 50 years with standard body-weights). Population bioequivalence ratios were estimated revealing that in vitro differences in drug release would have a major impact in carvedilol maximum plasma concentration, leading to a non-bioequivalence outcome. Predictions support the need to perform in vivo bioequivalence for these products of extensive use. Application of the in vitro-in silico-in vivo approach stands as an interesting alternative to tackle and reduce drug product variability in biopharmaceutical quality. Copyright © 2018 Elsevier B.V. All rights reserved.

  8. Psychological functioning and adherence to the recommended dose of physical activity in later life: results from a national health survey.

    Science.gov (United States)

    Netz, Yael; Dunsky, Ayelet; Zach, Sima; Goldsmith, Rebecca; Shimony, Tal; Goldbourt, Uri; Zeev, Aviva

    2012-12-01

    Official health organizations have established the dose of physical activity needed for preserving both physical and psychological health in old age. The objective of this study was to explore whether adherence to the recommended criterion of physical activity accounted for better psychological functioning in older adults in Israel. A random sample of 1,663 (799 men) Israelis reported their physical activity routine, and based on official guidelines were divided into sufficiently active, insufficiently active, and inactive groups. The General Health Questionnaire (GHQ) was used for assessing mental health and the Mini-Mental State Examination (MMSE) for assessing cognitive functioning. Factor analysis performed on the GHQ yielded two factors - positive and negative. Logistic regressions for the GHQ factors and for the MMSE were conducted for explaining their variance, with demographic variables entered first, followed by health and then physical activity. The explained variance in the three steps was Cox and Snell R2 = 0.022, 0.023, 0.039 for the positive factor, 0.066, 0.093, 0.101 for the negative factor, and 0.204, 0.206, 0.209 for the MMSE. Adherence to the recommended dose of physical activity accounted for better psychological functioning beyond demographic and health variables; however, the additional explained variance was small. More specific guidelines of physical activity may elucidate a stronger relationship, but only randomized controlled trials can reveal cause-effect relationship between physical activity and psychological functioning. More studies are needed focusing on the positive factor of psychological functioning.

  9. Structured Observation of School Administrator Work Activities: Methodological Limitations and Recommendations for Research, Part 1.

    Science.gov (United States)

    Pitner, Nancy J.; Russell, James S.

    1986-01-01

    This paper critically reviews studies of administrator work activities which follow the work of Henry Mintzberg (1973), concentrating on these shortcomings of the method: (1) procedural difficulties in coding; (2) design limitations of classifying activities; (3) inadequate testing of Mintzberg's hypotheses; and (4) failure to explore antecedents…

  10. University Students Meeting the Recommended Standards of Physical Activity and Body Mass Index

    Science.gov (United States)

    Deng, Xiaofen; Castelli, Darla; Castro-Pinero, Jose; Guan, Hongwei

    2011-01-01

    This study investigated student physical activity (PA) and body mass index (BMI) in relation to the "Healthy Campus 2010" objectives set by the American College Health Association in 2002. Students (N = 1125) at a U.S. southern state university participated in the study. The percentages of students who were physically active and whose…

  11. Solid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycin

    KAUST Repository

    Al-Talla, Zeyad

    2011-01-01

    Objective: The purpose of this study was to compare the pharmacokinetic parameters and determine the bioequivalence of a generic formulation of clindamycin that is sold in the local markets in the Middle East (Clindox® 150 mg capsule; test) with a reference formulation (Dalacin C® 150 mg capsule) in healthy adult male volunteers. Methods: A single-dose, open-label, 2-period crossover study was conducted. Healthy male volunteers were randomly assigned to oral administration of a single treatment of the reference and test formulations. The same groups were given the alternate formulation. After dosing, serial blood samples were withdrawn for a period of 24 h. Serum harvested from the blood samples was analyzed for clindamycin by high performance liquid chromatography (HPLC) with ultraviolet detection. Pharmacokinetic parameters, including AUC0-∞, AUC 0-t, Cmax, Ke, tmax and t 1/2 were determined from the serum concentrations for both formulations (test and reference). The products were tested for bioequivalence after log-transformation of the data. Results: 24 healthy adult male volunteers from Jordan (mean [SD] age, 28.8 (7.7) years (range 19-45 years); height, 175.8 (10.6) cm (range 159.0-192.0 cm); weight, 75.6 (11.0) kg (range 58-101 kg); and body mass index, 24.4 (1.8) kg/m2 (range 21.3-28 kg/m2)) were enrolled in and completed the study. The 13C NMR spectra for both Dalacin C® and Clindox® showed 18 distinct lines associated with the 18 different carbon atoms. Conclusion: The statistical comparison suggested that Clindox® capsules are bioequivalent to Dalacin C® capsules. The 13C CPMAS results confirmed that the two drugs exhibit typical clindamycin spectra. ©2011 Dustri-Verlag Dr. K. Feistle.

  12. Not Just "A Walking the Dog": Dog Walking and Pet Play and Their Association With Recommended Physical Activity Among Adolescents.

    Science.gov (United States)

    Martin, Karen E; Wood, Lisa; Christian, Hayley; Trapp, Georgina S A

    2015-01-01

    To examine the role of pet play and dog walking in children's and adolescents' leisure time, and the relationship between these activities and physical activity. The study design was observational. The study setting was metropolitan Perth and nonmetropolitan regions in Western Australia. The study included 1097 primary school (mean age, 10.1 years; SD, 1.6 years) and 657 secondary school (mean age, 14.0 years; SD, 1.3 years) students. Validated measures of total physical activity, dog walking, and pet play activity (prevalence and time) were calculated. Generalized linear models tested for differences between proportions, while adjusting for socioeconomic status, age, and school-level clustering. Approximately one third of primary school and one quarter of secondary school students reported that they walked the dog at least once in the last week. Pet play was the most common play activity for primary and secondary school girls, and the second and third most popular play activity for secondary and primary school boys, respectively. Secondary school students who walked the dog or played with pets spent an average of 1 hour per week on each activity, and they were significantly more likely (p physical activity recommendations than secondary school students not reporting these activities. Given the significant proportion of young people who frequently engage in dog walking and pet play, and the high level of pet ownership in many Western countries, promotion of these activities to support young people's health is warranted.

  13. The relationship between meeting vigorous physical activity recommendations and burnout symptoms among adolescents: an exploratory study with vocational students.

    Science.gov (United States)

    Elliot, Catherine; Lang, Christin; Brand, Serge; Holsboer-Trachsler, Edith; Pühse, Uwe; Gerber, Markus

    2015-04-01

    This study examines how students who met the current recommendations for vigorous physical activity (VPA) of the American College of Sports Medicine (ACSM) and the Centers of Disease Control and Prevention (CDC) differ from peers who did not reach these standards with regard to self-reported burnout, before and after controlling for light physical activity and moderate physical activity. A sample of 144 vocational students (Mage =16.2 years, SD = 1.13, 98 males) completed the International Physical Activity Questionnaire, the Shirom-Melamed Burnout Measure, and the School Burnout Inventory. Bivariate correlations revealed that only VPA was associated with reduced burnout. Both the ACSM and CDC guidelines were useful to identify significant differences in burnout symptoms between students who met versus did not meet the standards. Health policy makers should develop strategies to integrate more VPA into the lives of adolescent students so as to reach a minimum of 60 min per week.

  14. Pharmacokinetic bioequivalence studies of a fixed-dose combination of tamsulosin and dutasteride in healthy volunteers.

    Science.gov (United States)

    Fossler, Michael J; Collins, David A; Thompson, Meg M; Nino, Antonio; Bianco, Joseph J; Chetty, Dushen

    2014-05-01

    The combination of dutasteride and tamsulosin may be more effective for the treatment of symptomatic benign prostatic hyperplasia than either treatment alone. We report the results of three pharmacokinetics and tolerability studies, which used a dutasteride/tamsulosin HCl (0.5 mg/0.2 mg) fixed-dose combination (FDC) capsules containing a small dutasteride soft gelatin capsule (smaller than commercial Avodart™) and modified-release tamsulosin pellets that have different amounts of enteric coating. These studies compared the test products to commercial Avodart™ (dutasteride 0.5 mg) and two different commercial tamsulosin HCl 0.2 mg products, Harnal™ Capsules or Harnal-D™ Tablets, which are reportedly bioequivalent to each other. All three studies were randomized single-dose studies in healthy male adults. Study 1 [N = 86 (NCT01254071)] was a two-period crossover study of a dutasteride/tamsulosin HCl FDC versus coadministered Avodart™ and Harnal-D™ Tablets. The pharmacokinetics of both dutasteride and tamsulosin were studied. Study 2 [N = 27 (NCT01471678)] was a four-period crossover study of dutasteride/tamsulosin HCl FDC formulations versus Avodart™ and Harnal™ Capsules or Harnal-D™ Tablets. Only the pharmacokinetics of tamsulosin were studied. Study 3 [N = 40 (NCT01495026)] was a two-period study of dutasteride/tamsulosin HCl FDC formulations versus coadministered Avodart™ and Harnal-D™ Tablets. In this study, only the pharmacokinetics of tamsulosin were studied. Study 2 assessed fed-state pharmacokinetics. Studies 1 and 3 assessed fed- and fasted-state pharmacokinetics. All dutasteride/tamsulosin HCl FDC formulations and coadministered treatments were well-tolerated. In Study 1, the FDC dutasteride was bioequivalent to Avodart™ coadministered with tamsulosin under fed and fasted conditions. In Study 1, the FDC tamsulosin had a slower release than commercial Harnal-D™ Tablets coadministered with dutasteride (fed and fasted

  15. Mobile Phone Use and its Association With Sitting Time and Meeting Physical Activity Recommendations in a Mexican American Cohort.

    Science.gov (United States)

    Chrisman, Matthew; Chow, Wong-Ho; Daniel, Carrie R; Wu, Xifeng; Zhao, Hua

    2016-06-16

    The benefits of physical activity (PA) are well-documented. Mobile phones influence PA by promoting screen-based sedentary time, providing prompts or reminders to be active, aiding in tracking and monitoring PA, or providing entertainment during PA. It is not known how mobile phone use is associated with PA and sitting time in Mexican Americans, and how mobile phone users may differ from nonusers. To determine the associations between mobile phone use, PA, and sitting time and how these behaviors differ from mobile phone nonusers in a sample of 2982 Mexican-American adults from the Mano a Mano cohort. Differences in meeting PA recommendations and sitting time between mobile phone users and nonusers were examined using chi-square and analysis of variance tests. Logistic regression was used to examine associations between mobile phone use, PA, and sitting. Mobile phone users were more likely to be obese by body mass index criteria (≥30 kg/m(2)), younger, born in the United States and lived there longer, more educated, and sit more hours per day but more likely to meet PA recommendations than nonusers. Males (odds ratio [OR] 1.42, 95% CI 1.16-1.74), use of text messaging (OR 1.26, 95% CI 1.03-1.56), and having a higher acculturation score (OR 1.27, 95% CI 1.07-1.52) were associated with higher odds of meeting PA recommendations. Sitting more hours per day was associated with being male, obese, born in the United States, a former alcohol drinker, and having at least a high school education. Among nonusers, being born in the United States was associated with higher odds of more sitting time, and being married was associated with higher odds of meeting PA recommendations. Mobile phone interventions using text messages could be tailored to promote PA in less acculturated and female Mexican American mobile phone users.

  16. Structured Observation of School Administrator Work Activities: Methodological Limitations and Recommendations for Research, Part II.

    Science.gov (United States)

    Pitner, Nancy J.; Russell, James S.

    1986-01-01

    This paper critically reviews administrator work activity studies which follow the research of Henry Mintzberg. It discusses directions for future research using qualitative and quantitative methods and discourages research that relies solely on Mintzberg's structure. (Author/JAZ)

  17. Current Limitations and Recommendations to Improve Testing for the Environmental Assessment of Endocrine Active Substances

    DEFF Research Database (Denmark)

    Coady, Katherine K; Biever, Ronald C; Denslow, Nancy D

    2017-01-01

    In this paper existing regulatory frameworks and test systems for assessing potential endocrine-active chemicals are described, and associated challenges discussed, along with proposed approaches to address these challenges. Regulatory frameworks vary somewhat across geographies, but all basically...... evaluate whether a chemical possesses endocrine activity and whether this activity can result in adverse outcomes either to humans or the environment. Current test systems include in silico, in vitro and in vivo techniques focused on detecting potential endocrine activity, and in vivo tests that collect...... methods currently do not exist, and addressing key endocrine pathways of possible concern in addition to those associated with estrogen, androgen and thyroid signaling. This article is protected by copyright. All rights reserved....

  18. An Active Sensor Algorithm for Corn Nitrogen Recommendations Based on a Chlorophyll Meter Algorithm

    Science.gov (United States)

    In previous work we found active canopy sensor reflectance assessments of corn (Zea mays L.) N status acquired at two growth stages (V11 and V15) have the greatest potential for directing in-season N applications, but emphasized an algorithm was needed to translate sensor readings into appropriate N...

  19. [Basic guidelines for detecting sedentarism and recommendations for physical activity in primary care].

    Science.gov (United States)

    Crespo-Salgado, Juan José; Delgado-Martín, José Luis; Blanco-Iglesias, Orlando; Aldecoa-Landesa, Susana

    2015-03-01

    The detection of physical inactivity in adults, using simple and useful tools is primary objective in both public health and in clinical settings, since this risk factor is one of the major causes of non-communicable disease in the world, and is very prevalent in developed societies such as in Spain. Two validated instruments are described that are simple and useful for detecting and/or monitoring physical inactivity in adults: (i)the international physical activity questionnaire in its short version, and (ii)the pedometer to measure the number of steps taken in a day. Increased levels of physical activity are important for the primary prevention of some chronic diseases (coronary heart disease, type2 diabetes, osteoporosis, colon cancer) and to improve the quality of life. Medical personnel must determine the motivation level and the availability of patients and their families to change their behavior towards physical activity. Moderate-intensity physical activities have hardly any contraindications and the risks are few. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

  20. Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine‐active substances

    Science.gov (United States)

    A SETAC Pellston Workshop™ ?‘Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)’ was held from 31st January to 5th February 2016 in Pensacola, Florida, USA. The primary aim of the workshop was to provide objective advice, based on current s...

  1. An ontology-based recommender system to promote physical activity for pre-frail elderly

    NARCIS (Netherlands)

    Nassabi, Hossein; op den Akker, Harm; Vollenbroek-Hutten, Miriam Marie Rosé

    2014-01-01

    The increasing ageing population and the prevalence of chronic diseases have introduced new challenges to healthcare systems motivating researchers to use telemonitoring solutions for providing care. In some solutions, a special focus has been given to promoting physical activity as it can decrease

  2. Meeting Recommended Levels of Physical Activity in Relation to Preventive Health Behavior and Health Status Among Adults

    Directory of Open Access Journals (Sweden)

    Peter D. Hart

    2017-01-01

    Full Text Available Objectives The purpose of this study was to examine the relationship of meeting the recommended levels of physical activity (PA with health status and preventive health behavior in adults. Methods A total of 5630 adults 18 years of age or older were included in this study. PA was assessed using a series of questions that categorized activities based on their metabolic equivalent values and then categorized individuals based on the reported frequency and duration of such activities. Participants reporting 150 minutes or more of moderate-intensity PA per week were considered to have met the PA guidelines. Multiple logistic regression was used to model the relationships between meeting PA guidelines and health status and preventive health behavior, while controlling for confounding variables. Results Overall, 53.9% (95% confidence interval [CI], 51.9 to 55.9% of adults reported meeting the recommended levels of PA. Among adults with good general health, 56.9% (95% CI, 54.7 to 59.1% reported meeting the recommended levels of PA versus 43.1% (95% CI, 40.9 to 45.3% who did not. Adults who met the PA guidelines were significantly more likely not to report high cholesterol, diabetes, chronic obstructive pulmonary disease, arthritis, asthma, depression, or overweight. Furthermore, adults meeting the PA guidelines were significantly more likely to report having health insurance, consuming fruits daily, consuming vegetables daily, and not being a current cigarette smoker. Conclusions In this study, we found meeting the current guidelines for PA to have a protective relationship with both health status and health behavior in adults. Health promotion programs should focus on strategies that help individuals meet the current guidelines of at least 150 minutes per week of moderate-intensity PA.

  3. Radiation protection requirements for organizations practising mining activities which can bring about exposure of personnel, public, or the environment. Recommendations

    International Nuclear Information System (INIS)

    1999-01-01

    The publication consists of the following articles: (1) Scope of State Office for Nuclear Safety recommendations; (2) Glossary of terms; (3) Radiation protection quantities; (4) General requirements for radiation protection and responsibilities of organizations; (5) Exposure limits; (6) Organizational and technical provisions of radiation protection; (7) Monitoring, measurement, evaluation, and recording of radiation protection-related quantities, parameters, and facts; (8) Utilization of monitoring data. Provisions to keep professional and public exposure within tolerable limits; (9) Decommissioning of workplaces handling ionizing radiation sources; (10) Waste handling; and (11) Transport of material arising from mining activities. The text is supplemented with 5 tabular annexes. (P.A)

  4. Merely asking the customer to recommend has an impact on word-of-mouth activity

    DEFF Research Database (Denmark)

    Mattsson, Jan; Söderlund, Magnus

    2015-01-01

    impact on customers' WOM activity. In addition, we found that receiving the request was not negatively associated with the customers' overall evaluations, such as customer satisfaction, which indicates that the potential for negative consequences of making the request seems to be low.......This paper examines if a mere request to a customer – within the frame of a service encounter – to engage in word-of-mouth (WOM) would have an impact on the customer's subsequent WOM activity. Although previous studies have not examined this issue, theoretical arguments do exist. And they point...... in different directions; some suggest a positive impact, while others suggest a negative impact. To explore the issue empirically, we carried out two studies (one survey-based study and one experiment). Both generated the same result: they indicate that merely asking customers to engage in WOM has a positive...

  5. A bioequivalence study of two tamsulosin sustained-release tablets in Indonesian healthy volunteers.

    Science.gov (United States)

    Prasaja, Budi; Harahap, Yahdiana; Lusthom, Windy; Setiawan, Evy C; Ginting, Mena B; Hardiyanti; Lipin

    2011-06-01

    The bioavailability of two 0.4 mg tamsulosin sustained-release film-coated tablet formulations was compared; using generic tablets (Prostam(®)) as test formulation and the originator product as reference formulation. Twenty-four subjects were included in this single-dose, open-label, randomized two-way crossover design following an overnight fasting. A one-week wash-out period was applied. Blood samples were drawn up to 72 h following drug administration. Plasma concentration of tamsulosin was determined by liquid chromatography-tandem mass spectrometry method with TurboIonSpray mode. Pharmacokinetic parameters AUC(0-t,) AUC(0-∞), C (max) and t (½) were determined and used for bioequivalence evaluation after log-transformation, whereas t (max) ratios were evaluated non-parametrically. The estimated point and 90% confidence intervals (CI) for AUC(0-t,) AUC(0-∞), C (max) and t (½) were 109.55% (96.41-124.49%), 109.94% (96.85-124.81%), 105.87% (92.88-120.67%) and 100.00% (90.56-110.43%), respectively. These results indicated that the two formulations of tamsulosin were bioequivalent; therefore they may be prescribed interchangeably.

  6. Bioequivalence Studies of a Reformulated Dutasteride and Tamsulosin Hydrochloride Combination Capsule and a Commercially Available Formulation.

    Science.gov (United States)

    Kurczewski, Renee; Bowen, Chet; Collins, David; Zhu, John; Serbest, Gulyeter; Manyak, Michael

    2017-09-01

    A dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg combination (DTC) capsule (Duodart ® ) was reformulated to reduce the capsule size and enhance product stability. Bioequivalence of the reformulated DTC capsule with the commercial formulation was evaluated in 2 single-dose, open-label, randomized, 2-way crossover studies in healthy adult male volunteers. Subjects in a fasted or fed state received a single oral dose of either the reformulated DTC or the commercial formulation followed by a 28-day washout period between treatments. Blood samples were taken predose and up to 72 hours postdose for pharmacokinetic (PK) analysis of dutasteride and tamsulosin serum concentrations. From the serum concentration-vs-time data, a noncompartmental method was used to calculate the maximum observed serum concentration (C max ) and area under the serum concentration-time curve (AUC 0-t ) for dutasteride and tamsulosin, and AUC 0-∞ for tamsulosin. The 90% confidence intervals for the ratios of the C max and AUC 0-t (for dutasteride and tamsulosin) and for AUC 0-∞ (for tamsulosin) were all completely contained within the range of 80% to 125%; therefore, the reformulated DTC capsule is bioequivalent to the commercial formulation under both fed and fasted states. © 2017, The American College of Clinical Pharmacology.

  7. Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination.

    Science.gov (United States)

    Wang, H F; Wang, R; O'Gorman, M; Crownover, P; Damle, B

    2015-03-01

    RIN(®)-150 is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg) and isoniazid (INH, 75 mg) developed for the treatment of tuberculosis. This study was conducted at a single center: the Pfizer Clinical Research Unit in Singapore. To demonstrate bioequivalence of each drug component between RIN-150 and individual products in a loose combination. This was a randomized, open-label, single-dose, two-way crossover study. Subjects received single doses of RIN-150 or two individual reference products under fasting conditions in a crossover fashion, with at least 7 days washout between doses. The primary measures for comparison were peak plasma concentration (Cmax) and the area under plasma concentration-time curve (AUC). Of 28 subjects enrolled, 26 completed the study. The adjusted geometric mean ratios of Cmax and AUClast between the FDC and single-drug references and 90% confidence intervals were respectively 91.63% (90%CI 83.13-101.01) and 95.45% (90%CI 92.07-98.94) for RMP, and 107.58% (90%CI 96.07-120.47) and 103.45% (90%CI 99.33-107.75) for INH. Both formulations were generally well tolerated in this study. The RIN-150 FDC tablet formulation is bioequivalent to the two single-drug references for RMP and INH at equivalent doses.

  8. Consumer response to healthy eating, physical activity and weight-related recommendations: a systematic review.

    Science.gov (United States)

    Boylan, S; Louie, J C Y; Gill, T P

    2012-07-01

    Strong evidence linking poor diet and lack of physical activity to risk of obesity and related chronic disease has supported the development and promotion of guidelines to improve population health. Still, obesity continues to escalate as a major health concern, and so the impact of weight-related guidelines on behaviour is unclear. The aim of this review was to examine consumer response to weight-related guidelines. A systematic literature search was performed using Medline, PsycInfo, ProQuest Central and additional searches using Google and reference lists. Of the 1,765 articles identified, 46 relevant titles were included. Most studies examined attitudes towards content, source, tailoring and comprehension of dietary guidelines. Many respondents reported that guidelines were confusing, and that simple, clear, specific, realistic, and in some cases, tailored guidelines are required. Recognition of guidelines did not signify understanding nor did perceived credibility of a source guarantee utilization of guidelines. There was a lack of studies assessing: the impact of guidelines on behaviour; responses to physical activity guidelines; responses among males and studies undertaken in developing countries. Further research is needed, in particular regarding responses to physical activity guidelines and guidelines in different populations. Communication professionals should assist health professionals in the development of accurate and effective weight-related guidelines. © 2012 The Authors. obesity reviews © 2012 International Association for the Study of Obesity.

  9. Physical Activity: A Tool for Improving Health (Part 3--Recommended Amounts of Physical Activity for Optimal Health)

    Science.gov (United States)

    Gallaway, Patrick J.; Hongu, Nobuko

    2016-01-01

    By promoting physical activities and incorporating them into their community-based programs, Extension professionals are improving the health of individuals, particularly those with limited resources. This article is the third in a three-part series describing the benefits of physical activity for human health: (1) biological health benefits of…

  10. Is physical activity, practiced as recommended for health benefit, a risk factor for osteoarthritis?

    Science.gov (United States)

    Lefèvre-Colau, Marie-Martine; Nguyen, Christelle; Haddad, Rebecca; Delamarche, Paul; Paris, Guillaume; Palazzo, Clémence; Poiraudeau, Serge; Rannou, François; Roren, Alexandra

    2016-06-01

    In this critical narrative review, we examine the role of physical activity (PA), recreational and elite sports in the development of knee/hip osteoarthritis (OA), taking into account the role of injury in this relationship. The process of article selection was unsystematic. Articles were selected on the basis of the authors' expertise, self-knowledge, and reflective practice. In the general adult population, self-reported diagnosis of knee/hip OA was not associated with low, moderate or high levels of PA. For studies using radiographic knee/hip OA as a primary outcome, the incidence of asymptomatic radiographic OA was higher for subjects with the highest quartile of usual PA than the least active subjects. The risk of incident radiographic knee/hip OA features was increased for subjects with a history of regular sports participation (for osteophyte formation but not joint space narrowing). This risk depended on the type of sport (team and power sports but not endurance and running), and certain conditions (high level of practice) were closely related to the risk of injury. The prevalence of radiographic OA was significantly higher, especially the presence of osteophytes, in former elite athletes than controls. The risk of OA was higher with participation in mixed sports, especially soccer or power sports, than endurance sport. However, the prevalence of clinical OA between former elite athletes and controls was similar, with less hip/knee disability in former athletes. Moderate daily recreational or sport activities, whatever the type of sport, are not a consistent risk factor for clinical or radiographic knee/hip OA. Risk of injury in different sports may be the key factor to understanding the risk of OA related to sport. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  11. Disease activity indices in coeliac disease: systematic review and recommendations for clinical trials.

    Science.gov (United States)

    Hindryckx, Pieter; Levesque, Barrett G; Holvoet, Tom; Durand, Serina; Tang, Ceen-Ming; Parker, Claire; Khanna, Reena; Shackelton, Lisa M; D'Haens, Geert; Sandborn, William J; Feagan, Brian G; Lebwohl, Benjamin; Leffler, Daniel A; Jairath, Vipul

    2018-01-01

    Although several pharmacological agents have emerged as potential adjunctive therapies to a gluten-free diet for coeliac disease, there is currently no widely accepted measure of disease activity used in clinical trials. We conducted a systematic review of coeliac disease activity indices to evaluate their operating properties and potential as outcome measures in registration trials. MEDLINE, EMBASE and the Cochrane central library were searched from 1966 to 2015 for eligible studies in adult and/or paediatric patients with coeliac disease that included coeliac disease activity markers in their outcome measures. The operating characteristics of histological indices, patient-reported outcomes (PROs) and endoscopic indices were evaluated for content and construct validity, reliability, responsiveness and feasibility using guidelines proposed by the US Food and Drug Administration (FDA). Of 19 123 citations, 286 studies were eligible, including 24 randomised-controlled trials. Three of five PROs identified met most key evaluative criteria but only the Celiac Disease Symptom Diary (CDSD) and the Celiac Disease Patient-Reported Outcome (CeD PRO) have been approved by the FDA. All histological and endoscopic scores identified lacked content validity. Quantitative morphometric histological analysis had better reliability and responsiveness compared with qualitative scales. Endoscopic indices were infrequently used, and only one index demonstrated responsiveness to effective therapy. Current best evidence suggests that the CDSD and the CeD PRO are appropriate for use in the definition of primary end points in coeliac disease registration trials. Morphometric histology should be included as a key secondary or co-primary end point. Further work is needed to optimise end point configuration to inform efficient drug development. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  12. Fluorescence detection of tramadol in healthy Chinese volunteers by high-performance liquid chromatography and bioequivalence assessment

    Directory of Open Access Journals (Sweden)

    Zhou X

    2015-02-01

    Full Text Available Xiao Zhou, Ji Liu Department of Anesthesia, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China Abstract: This study developed a revised high-performance liquid chromatography fluorescence method to determine plasma tramadol concentration, and thereby to examine the bioequivalence of two tramadol formulations among healthy male Chinese volunteers. The study used a double-blind, randomized, 2×2 crossover-design principle. Calculated pharmacokinetic parameters for both formulations were consistent with previous reports. According to the observation of vital signs and laboratory measurement, no subjects had any adverse reactions. The geometric mean ratios (90% confidence interval of the test drug/reference drug for tramadol were 100.2% (95.3%–103.4% for the area under the plasma concentration–time curve (AUC from time zero to the last measurable concentration, 99.6% (94.2%–102.7% for the AUC from administration to infinite time, and 100.8% (93.1%–106.4% for maximum concentration. For the 90% confidence intervals of the test/reference AUC ratio and maximum concentration ratio of tramadol, both were in the acceptance range for bioequivalence. According to the two preparations by pharmacokinetic parameter statistics, the half-life, mean residence time, and clearance values showed no significant statistical differences. Therefore, the conclusion of this study was that the two tramadol formulations (tablets and capsules were bioequivalent. Keywords: tramadol hydrochloride, in vitro release, pharmacokinetic, bioequivalence, fluorescence detector

  13. Influence of a microemulsion vehicle on cutaneous bioequivalence of a lipophilic model drug assessed by microdialysis and pharmacodynamics

    DEFF Research Database (Denmark)

    Kreilgaard, Mads; Kemme, M J; Burggraaf, J

    2001-01-01

    The aim of the study was to investigate the cutaneous bioequivalence of a lipophilic model drug (lidocaine) applied in a novel topical microemulsion vehicle, compared to a conventional oil-in-water (O/W) emulsion, assessed by a pharmacokinetics microdialysis model and a pharmacodynamic method....

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

    Directory of Open Access Journals (Sweden)

    Rita R Alloway

    2017-11-01

    Full Text Available Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, "brand" product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns. Such concerns have been fueled by anecdotal observations and retrospective and uncontrolled published studies, while well-designed, controlled prospective studies testing the validity of the regulatory bioequivalence testing approach for narrow therapeutic index immunosuppressants in transplant recipients have been lacking. Thus, the present study prospectively assesses bioequivalence between innovator tacrolimus and 2 generics in individuals with a kidney or liver transplant.From December 2013 through October 2014, a prospective, replicate dosing, partially blinded, randomized, 3-treatment, 6-period crossover bioequivalence study was conducted at the University of Cincinnati in individuals with a kidney (n = 35 or liver transplant (n = 36. Abbreviated New Drug Applications (ANDA data that included manufacturing and healthy individual pharmacokinetic data for all generics were evaluated to select the 2 most disparate generics from innovator, and these were named Generic Hi and Generic Lo. During the 8-week study period, pharmacokinetic studies assessed the bioequivalence of Generic Hi and Generic Lo with the Innovator tacrolimus and with each other. Bioequivalence of the major tacrolimus metabolite was also assessed. All products fell within the US Food and Drug

  15. International recommendations

    International Nuclear Information System (INIS)

    Lindell, Bo

    1986-01-01

    Publication 40, the ICRP has recommended ranges of action levels for some remedial actions, including the withdrawal of contaminated food-stuffs from the market. Similar recommendations have been issued by IAEA and WHO. From recommended values of action levels for radiation dose, derived action levels for intakes (e.g. annual intakes) of various radionuclides may be calculated, provided that the relative proportions of all significant radionuclides are known. Values of such derived action levels have been published by the IAEA in its Safety Series No. 81. On these bases, national authorities, have intervened to give 'limits' or 'reference values' for activity concentrations (in Bq/kg) for some or all food-stuffs. It should be realized, however, that the actual activity intake, and hence the radiation dose and risk, depend not only on the activity concentration but also on the quantities of particular food-stuffs actually consumed. (author)

  16. Recommended survey designs for occupancy modelling using motion-activated cameras: insights from empirical wildlife data

    Directory of Open Access Journals (Sweden)

    Graeme Shannon

    2014-08-01

    Full Text Available Motion-activated cameras are a versatile tool that wildlife biologists can use for sampling wild animal populations to estimate species occurrence. Occupancy modelling provides a flexible framework for the analysis of these data; explicitly recognizing that given a species occupies an area the probability of detecting it is often less than one. Despite the number of studies using camera data in an occupancy framework, there is only limited guidance from the scientific literature about survey design trade-offs when using motion-activated cameras. A fuller understanding of these trade-offs will allow researchers to maximise available resources and determine whether the objectives of a monitoring program or research study are achievable. We use an empirical dataset collected from 40 cameras deployed across 160 km2 of the Western Slope of Colorado, USA to explore how survey effort (number of cameras deployed and the length of sampling period affects the accuracy and precision (i.e., error of the occupancy estimate for ten mammal and three virtual species. We do this using a simulation approach where species occupancy and detection parameters were informed by empirical data from motion-activated cameras. A total of 54 survey designs were considered by varying combinations of sites (10–120 cameras and occasions (20–120 survey days. Our findings demonstrate that increasing total sampling effort generally decreases error associated with the occupancy estimate, but changing the number of sites or sampling duration can have very different results, depending on whether a species is spatially common or rare (occupancy = ψ and easy or hard to detect when available (detection probability = p. For rare species with a low probability of detection (i.e., raccoon and spotted skunk the required survey effort includes maximizing the number of sites and the number of survey days, often to a level that may be logistically unrealistic for many studies. For common

  17. Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine-active substances

    DEFF Research Database (Denmark)

    Matthiessen, Peter; Ankley, Gerald T.; Biever, Ronald C

    2017-01-01

    A SETAC Pellston Workshop(®) "Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)" was held in February 2016 in Pensacola, Florida, USA. The primary objective of the workshop was to provide advice, based on current scientific understanding, to regulators...... and policy makers; the aim being to make considered, informed decisions on whether to select an ecotoxicological hazard- or a risk-based approach for regulating a given endocrine-disrupting substance (EDS) under review. The workshop additionally considered recent developments in the identification of EDS...... at multiple biological levels of organization for 1 or more ecologically relevant taxa. The substances selected were 17α-ethinylestradiol, perchlorate, propiconazole, 17β-trenbolone, tributyltin, and vinclozolin. The 6 case studies were not comprehensive safety evaluations but provided foundations...

  18. Identification of potent orally active factor Xa inhibitors based on conjugation strategy and application of predictable fragment recommender system.

    Science.gov (United States)

    Ishihara, Tsukasa; Koga, Yuji; Iwatsuki, Yoshiyuki; Hirayama, Fukushi

    2015-01-15

    Anticoagulant agents have emerged as a promising class of therapeutic drugs for the treatment and prevention of arterial and venous thrombosis. We investigated a series of novel orally active factor Xa inhibitors designed using our previously reported conjugation strategy to boost oral anticoagulant effect. Structural optimization of anthranilamide derivative 3 as a lead compound with installation of phenolic hydroxyl group and extensive exploration of the P1 binding element led to the identification of 5-chloro-N-(5-chloro-2-pyridyl)-3-hydroxy-2-{[4-(4-methyl-1,4-diazepan-1-yl)benzoyl]amino}benzamide (33, AS1468240) as a potent factor Xa inhibitor with significant oral anticoagulant activity. We also reported a newly developed Free-Wilson-like fragment recommender system based on the integration of R-group decomposition with collaborative filtering for the structural optimization process. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Modeling of novel diagnostic strategies for active tuberculosis - a systematic review: current practices and recommendations.

    Directory of Open Access Journals (Sweden)

    Alice Zwerling

    Full Text Available The field of diagnostics for active tuberculosis (TB is rapidly developing. TB diagnostic modeling can help to inform policy makers and support complicated decisions on diagnostic strategy, with important budgetary implications. Demand for TB diagnostic modeling is likely to increase, and an evaluation of current practice is important. We aimed to systematically review all studies employing mathematical modeling to evaluate cost-effectiveness or epidemiological impact of novel diagnostic strategies for active TB.Pubmed, personal libraries and reference lists were searched to identify eligible papers. We extracted data on a wide variety of model structure, parameter choices, sensitivity analyses and study conclusions, which were discussed during a meeting of content experts.From 5619 records a total of 36 papers were included in the analysis. Sixteen papers included population impact/transmission modeling, 5 were health systems models, and 24 included estimates of cost-effectiveness. Transmission and health systems models included specific structure to explore the importance of the diagnostic pathway (n = 4, key determinants of diagnostic delay (n = 5, operational context (n = 5, and the pre-diagnostic infectious period (n = 1. The majority of models implemented sensitivity analysis, although only 18 studies described multi-way sensitivity analysis of more than 2 parameters simultaneously. Among the models used to make cost-effectiveness estimates, most frequent diagnostic assays studied included Xpert MTB/RIF (n = 7, and alternative nucleic acid amplification tests (NAATs (n = 4. Most (n = 16 of the cost-effectiveness models compared new assays to an existing baseline and generated an incremental cost-effectiveness ratio (ICER.Although models have addressed a small number of important issues, many decisions regarding implementation of TB diagnostics are being made without the full benefits of insight from mathematical

  20. ESC Study Group of Sports Cardiology: recommendations for participation in leisure-time physical activity and competitive sports for patients with ischaemic heart disease.

    NARCIS (Netherlands)

    Borjesson, M.; Assanelli, D.; Carre, F.; Dugmore, D.; Panhuyzen-Goedkoop, N.M.; Seiler, C.; Senden, J.; Solberg, E.E.

    2006-01-01

    BACKGROUND: Evidence for the proper management of ischemic heart disease (IHD) in the general population is well established, but recommendations for physical activity and competitive sports in these patients are scarce. The aim of the present paper was to provide such recommendations to complement

  1. Protein turnover, amino acid requirements and recommendations for athletes and active populations

    International Nuclear Information System (INIS)

    Poortmans, J.R.; Carpentier, A.; Pereira-Lancha, L.O.; Lancha, A. Jr.

    2012-01-01

    Skeletal muscle is the major deposit of protein molecules. As for any cell or tissue, total muscle protein reflects a dynamic turnover between net protein synthesis and degradation. Noninvasive and invasive techniques have been applied to determine amino acid catabolism and muscle protein building at rest, during exercise and during the recovery period after a single experiment or training sessions. Stable isotopic tracers ( 13 C-lysine, 15 N-glycine, 2 H 5 -phenylalanine) and arteriovenous differences have been used in studies of skeletal muscle and collagen tissues under resting and exercise conditions. There are different fractional synthesis rates in skeletal muscle and tendon tissues, but there is no major difference between collagen and myofibrillar protein synthesis. Strenuous exercise provokes increased proteolysis and decreased protein synthesis, the opposite occurring during the recovery period. Individuals who exercise respond differently when resistance and endurance types of contractions are compared. Endurance exercise induces a greater oxidative capacity (enzymes) compared to resistance exercise, which induces fiber hypertrophy (myofibrils). Nitrogen balance (difference between protein intake and protein degradation) for athletes is usually balanced when the intake of protein reaches 1.2 g·kg −1 ·day −1 compared to 0.8 g·kg −1 ·day −1 in resting individuals. Muscular activities promote a cascade of signals leading to the stimulation of eukaryotic initiation of myofibrillar protein synthesis. As suggested in several publications, a bolus of 15-20 g protein (from skimmed milk or whey proteins) and carbohydrate (± 30 g maltodextrine) drinks is needed immediately after stopping exercise to stimulate muscle protein and tendon collagen turnover within 1 h

  2. Protein turnover, amino acid requirements and recommendations for athletes and active populations

    Energy Technology Data Exchange (ETDEWEB)

    Poortmans, J.R.; Carpentier, A. [Laboratory for Biometry and Sport Nutrition, Faculty of Motor Sciences, Free University of Brussels, Brussels (Belgium); Pereira-Lancha, L.O. [Departamento de Nutrição, Instituto Vita, São Paulo, SP (Brazil); Lancha, A. Jr. [Laboratório de Nutrição Aplicada à Atividade Motora, Escola de Educação Física e Esporte, Universidade de São Paulo, São Paulo, SP (Brazil)

    2012-06-08

    Skeletal muscle is the major deposit of protein molecules. As for any cell or tissue, total muscle protein reflects a dynamic turnover between net protein synthesis and degradation. Noninvasive and invasive techniques have been applied to determine amino acid catabolism and muscle protein building at rest, during exercise and during the recovery period after a single experiment or training sessions. Stable isotopic tracers ({sup 13}C-lysine, {sup 15}N-glycine, {sup 2}H{sub 5}-phenylalanine) and arteriovenous differences have been used in studies of skeletal muscle and collagen tissues under resting and exercise conditions. There are different fractional synthesis rates in skeletal muscle and tendon tissues, but there is no major difference between collagen and myofibrillar protein synthesis. Strenuous exercise provokes increased proteolysis and decreased protein synthesis, the opposite occurring during the recovery period. Individuals who exercise respond differently when resistance and endurance types of contractions are compared. Endurance exercise induces a greater oxidative capacity (enzymes) compared to resistance exercise, which induces fiber hypertrophy (myofibrils). Nitrogen balance (difference between protein intake and protein degradation) for athletes is usually balanced when the intake of protein reaches 1.2 g·kg{sup −1}·day{sup −1} compared to 0.8 g·kg{sup −1}·day{sup −1} in resting individuals. Muscular activities promote a cascade of signals leading to the stimulation of eukaryotic initiation of myofibrillar protein synthesis. As suggested in several publications, a bolus of 15-20 g protein (from skimmed milk or whey proteins) and carbohydrate (± 30 g maltodextrine) drinks is needed immediately after stopping exercise to stimulate muscle protein and tendon collagen turnover within 1 h.

  3. Protein turnover, amino acid requirements and recommendations for athletes and active populations

    Directory of Open Access Journals (Sweden)

    J.R. Poortmans

    2012-10-01

    Full Text Available Skeletal muscle is the major deposit of protein molecules. As for any cell or tissue, total muscle protein reflects a dynamic turnover between net protein synthesis and degradation. Noninvasive and invasive techniques have been applied to determine amino acid catabolism and muscle protein building at rest, during exercise and during the recovery period after a single experiment or training sessions. Stable isotopic tracers (13C-lysine, 15N-glycine, ²H5-phenylalanine and arteriovenous differences have been used in studies of skeletal muscle and collagen tissues under resting and exercise conditions. There are different fractional synthesis rates in skeletal muscle and tendon tissues, but there is no major difference between collagen and myofibrillar protein synthesis. Strenuous exercise provokes increased proteolysis and decreased protein synthesis, the opposite occurring during the recovery period. Individuals who exercise respond differently when resistance and endurance types of contractions are compared. Endurance exercise induces a greater oxidative capacity (enzymes compared to resistance exercise, which induces fiber hypertrophy (myofibrils. Nitrogen balance (difference between protein intake and protein degradation for athletes is usually balanced when the intake of protein reaches 1.2 g·kg-1·day-1 compared to 0.8 g·kg-1·day-1 in resting individuals. Muscular activities promote a cascade of signals leading to the stimulation of eukaryotic initiation of myofibrillar protein synthesis. As suggested in several publications, a bolus of 15-20 g protein (from skimmed milk or whey proteins and carbohydrate (± 30 g maltodextrine drinks is needed immediately after stopping exercise to stimulate muscle protein and tendon collagen turnover within 1 h.

  4. Bioequivalence study of two losartan tablet formulations with special emphasis on cardiac safety.

    Science.gov (United States)

    Khandave, Suhas S; Sawant, Satish V; Sahane, Rakhi V; Murthi, Vivekanand; Dhanure, Shivanand S; Surve, Pradeep G

    2012-05-01

    To study the bioequivalence of Losartan Potassium Tablets 50 mg manufactured by Micro Labs Ltd. India to Cozaar® Tablets 50 mg, manufactured by Merck Sharp and Dohme Ltd., UK in normal healthy adult subjects under fasting condition along with the comparative safety evaluation of both treatments. The in vitro dissolution studies were carried out on 12 units each of test and reference products using the paddle method and dissolution media like water, 0.1 N hydrochloric acid with pH 1.2, pH 4.5 acetate buffer and pH 6.8 phosphate buffer. An open label, randomized, two-treatment, two-period, two-sequence, crossover bioequivalence study with a washout period of 7 days was conducted in 60 healthy Indian male subjects. Serial blood samples were collected after drug administration in each study period. Plasma concentrations of losartan and losartan acid were determined using a validated LC-MS-MS method. The pharmacokinetic parameters of losartan and losartan acid were determined using a non compartmental model. Occurrence of adverse events, change in systolic blood pressure, diastolic blood pressure, heart rate and QT interval from the baseline to 3.50 h post dose were studied and compared between the two treatments as safety parameters. The in vitro study proved the essential similarity of both the formulations as evident from the similarity factor of > 50% in all the dissolution media. The ratios for geometric least square means and 90% confidence intervals were within the acceptance criteria of 80% to 125% for log transformed C(max), AUC(0-t) and AUC(0-∞) for losartan. No statistically significant difference between the two treatments was observed for either of the safety parameters. The test product Losartan Potassium tablets 50 mg manufactured by Micro Labs Limited, India was bioequivalent to Cozaar® tablets 50 mg, manufactured by Merck Sharp and Dohme Ltd., UK in terms of rate and extent of absorption. Both treatments were well tolerated and had similar non

  5. Effects of Juvenile Idiopathic Arthritis on Kinematics and Kinetics of the Lower Extremities Call for Consequences in Physical Activities Recommendations

    Directory of Open Access Journals (Sweden)

    M. Hartmann

    2010-01-01

    Full Text Available Juvenile idiopathic arthritis (JIA patients (n=36 with symmetrical polyarticular joint involvement of the lower extremities and healthy controls (n=20 were compared concerning differences in kinematic, kinetic, and spatio-temporal parameters with 3D gait analysis. The aims of this study were to quantify the differences in gait between JIA patients and healthy controls and to provide data for more detailed sport activities recommendations. JIA-patients showed reduced walking speed and step length, strongly anterior tilted pelvis, reduced maximum hip extension, reduced knee extension during single support phase and reduced plantar flexion in push off. Additionally the roll-off procedure of the foot was slightly decelerated. The reduced push off motion in the ankle was confirmed by lower peaks in ankle moment and power. The gait of JIA-patients can be explained as a crouch-like gait with hyperflexion in hip and knee joints and less plantar flexion in the ankle. A preventive mobility workout would be recommendable to reduce these restrictions in the future. Advisable are sports with emphasis on extension in hip, knee, and ankle plantar flexion.

  6. Recommendations for participation in leisure-time physical activity and competitive sports in patients with arrhythmias and potentially arrhythmogenic conditions Part I: Supraventricular arrhythmias and pacemakers.

    NARCIS (Netherlands)

    Heidbuchel, H.; Panhuyzen-Goedkoop, N.M.; Corrado, D.; Hoffmann, E.; Biffi, A.; Delise, P.; Blomstrom-Lundqvist, C.; Vanhees, L.; Ivarhoff, P.; Dorwarth, U.; Pelliccia, A.

    2006-01-01

    This document by the Study Group on Sports Cardiology of the European Society of Cardiology extends on previous recommendations for sports participation for competitive athletes by also incorporating guidelines for those who want to perform recreational physical activity. For different

  7. Proposing the Use of Partial AUC as an Adjunctive Measure in Establishing Bioequivalence Between Deltoid and Gluteal Administration of Long-Acting Injectable Antipsychotics.

    Science.gov (United States)

    Lee, Lik Hang N; Choi, Charles; Gershkovich, Pavel; Barr, Alasdair M; Honer, William G; Procyshyn, Ric M

    2016-12-01

    The maximum plasma concentration (C max ) and the area under the plasma concentration-time curve (AUC) are commonly used to establish bioequivalence between two formulations of the same oral medication. Similarly, these pharmacokinetic parameters have also been used to establish bioequivalence between two sites of administration for the same injectable formulation. However, these conventional methods of establishing bioequivalence are of limited use when comparing modified-release formulations of a drug, particularly those with rates of absorption that are amenable to change with the site of injection. Inherent differences in the rate of absorption can result in clinically significant differences in early exposure and drug response. Here, we propose the use of the partial AUC (pAUC) as a measure of early exposure to aid in the assessment of bioequivalence between the gluteal and the deltoid site of administration for long-acting injectable antipsychotics.

  8. Relations of meeting national public health recommendations for muscular strengthening activities with strength, body composition, and obesity: the Women's Injury Study.

    Science.gov (United States)

    Trudelle-Jackson, Elaine; Jackson, Allen W; Morrow, James R

    2011-10-01

    We examined the relations of meeting or not meeting the 2008 Physical Activity Guidelines for Americans recommendations for muscular strengthening activities with percentage of body fat, body mass index (BMI; defined as weight in kilograms divided by height in meters, squared), muscular strength, and obesity classification in women. We analyzed data on 918 women aged 20 to 83 years in the Women's Injury Study from 2007 to 2009. A baseline orthopedic examination included measurement of height, body weight, skinfolds, and muscle strength. Women who met muscle strengthening activity recommendations had significantly lower BMI and percentage of body fat and higher muscle strength. Women not meeting those recommendations were more likely to be obese (BMI ≥ 30) compared with women who met the recommendations after we adjusted for age, race, and aerobic physical activity (odds ratio = 2.28; 95% confidence interval = 1.61, 3.23). There was a small but significant positive association between meeting muscle strengthening activity recommendations and muscular strength, a moderate inverse association with body fat percentage, and a strong inverse association with obesity classification, providing preliminary support for the muscle strengthening activity recommendation for women.

  9. Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs.

    Science.gov (United States)

    van Gelder, Teun; Gabardi, Steven

    2013-08-01

    Within the field of solid organ transplantation, the patents for a number of immunosuppressive drugs have expired in the last few years. Tacrolimus, cyclosporine, and mycophenolate mofetil are now available as generic drugs. In some countries, the market penetration of these generic formulations is as high as 70%, whereas in some other countries, this figure is below 10%. Several professional societies have published position papers on the risks and benefits of generic substitution of immunosuppressive drugs. It often appears that transplant professionals are not fully aware of the requirements for registration of generic drugs. This article describes the registration requirements with a focus on bioequivalence testing, the strengths and weaknesses in this process, and the differences between Europe and the US. © 2013 The Authors Transplant International © 2013 European Society for Organ Transplantation. Published by Blackwell Publishing Ltd.

  10. Comparative bioequivalence study of rifampicin and isoniazid combinations in healthy volunteers.

    Science.gov (United States)

    Padgaonkar, K A; Revankar, S N; Bhatt, A D; Vaz, J A; Desai, N D; D'Sa, S; Shah, V; Gandewar, K

    1999-07-01

    To assess the bioavailability of rifampicin (RMP) in three brands of combination formulations of anti-tuberculosis drugs. A three-way double-blind, cross-over bioavailability study of RMP and isoniazid (INH), consisting of a comparison of a two-drug combination of tablets of RMP and INH each separately (reference brand R) and a tablet of RMP + INH (brand N), and a capsule of RMP + INH (brand L) was carried out in 12 healthy male volunteers. Coded plasma samples were analysed for levels of RMP as well as INH and acetylisoniazid (ACINH) by two high performance liquid chromatography (HPLC) methods. The mean values of RMP in brand N (Cmax 6.49+/-0.52 microg/mL, Tmax 2.33+/-0.18 h, AUC(0-24h) 39.83+/-3.44 microg/mL.h) were comparable with those obtained with brand R (Cmax 5.22+/-0.59 microg/mL, Tmax 2.50+/-0.12 h, AUC(0-24h) 33.33+/-3.47 microg/mL.h). The mean values of RMP in brand L (Cmax 3.05+/-0.52 microg/ mL, Tmax 3.79+/-0.57 h and AUC(0-24h) 21.78+/-3.67 microg/ mL.h) were significantly different from those in brand R. Nevertheless, all of the pharmacokinetic parameters obtained for INH and ACINH in all three brands were comparable. Using brand R as a comparison, brand N was bioequivalent and brand L was not bioequivalent.

  11. Assessment of bioequivalence of rifampicin, isoniazid and pyrazinamide in a four drug fixed dose combination with separate formulations at the same dose levels.

    Science.gov (United States)

    Agrawal, Shrutidevi; Kaur, Kanwal Jit; Singh, Inderjit; Bhade, Shantaram R; Kaul, Chaman Lal; Panchagnula, Ramesh

    2002-02-21

    Tuberculosis (TB) needs treatment with three to five different drugs simultaneously, depending on the patient category. These drugs can be given as single drug preparations or fixed dose combinations (FDCs) of two more drugs in a single formulation. World Health Organization and International Union against Tuberculosis and Lung Disease (IUATLD) recommend FDCs only of proven bioavailability. The relative bioavailability of rifampicin (RIF), isoniazid (INH) and pyrazinamide (PYZ) was assessed on a group of 13 healthy male subjects from a four drug FDC versus separate formulations at the same dose levels. The study was designed to be an open, crossover experiment. A total of nine blood samples each of 3 ml volume were collected over a period of 24-h. The concentrations of RIF, its main metabolite desacetyl RIF (DRIF), INH and PYZ in plasma were assessed by HPLC analysis. Pharmacokinetic parameters namely AUC(0-24), AUC(0-inf), C(max), T(max), were calculated and subjected to different statistical tests (Hauschke analysis, two way ANOVA, normal and log transformed confidence interval) at 90% confidence interval. In addition, elimination rate constant (K(el)) and absorption efficiencies for each drug were also calculated. It was concluded that four drugs FDC tablet is bioequivalent for RIF, INH and PYZ to separate formulation at the same dose levels.

  12. Bioequivalence assessment of rifampicin, isoniazid and pyrazinamide in a fixed dose combination of rifampicin, isoniazid, pyrazinamide and ethambutol vs. separate formulations.

    Science.gov (United States)

    Agrawal, S; Singh, I; Kaur, K J; Bhade, S R; Kaul, C L; Panchagnula, R

    2002-10-01

    Depending on the patient category, tuberculosis requires treatment with 3 to 5 drugs which means that patient's compliance to therapy may not be optimal. To increase patient's adherence to treatment schedules, these drugs can be given as single drug preparations or fixed dose combinations (FDCs) of 2 or more drugs in a single formulation. However, an important issue associated with a rifampicin-containing FDC is its quality. Hence, to avoid spurious formulations entering the market, the World Health Organization and the International Union Against Tuberculosis and Lung Disease have recommended FDCs only of proven bioavailability. In this study, the relative bioavailability of rifampicin, isoniazid and pyrazinamide was assessed in a group of 14 healthy male subjects using the FDC tablet containing 4 drugs versus separate formulations at the same dose levels. The study was designed as an open, crossover trial. A total of 9 blood samples were collected over a period of 24 h. The concentration of rifampicin, its main metabolite desacetyl rifampicin, isoniazid and pyrazinamide in plasma were assessed using HPLC analysis. The pharmacokinetic parameters AUC(0-24) and Cmax were subjected to parametric and non-parametric statistical tests at 90% confidence interval. In addition, time to reach peak concentration (tmax), elimination rate constant (Kel) and terminal elimination half-life (t1/2) for each drug were also calculated. It was concluded that the FDC tablet containing 4 drugs is bioequivalent to separate rifampicin, isoniazid and pyrazinamide formulations at the same dose levels.

  13. Recommender systems

    OpenAIRE

    Lu L.; Medo M.; Yeung C.H.; Zhang Y.-C.; Zhang Z.-K.; Zhou T.

    2012-01-01

    The ongoing rapid expansion of the Internet greatly increases the necessity of effective recommender systems for filtering the abundant information. Extensive research for recommender systems is conducted by a broad range of communities including social and computer scientists, physicists, and interdisciplinary researchers. Despite substantial theoretical and practical achievements, unification and comparison of different approaches are lacking, which impedes further advances. In this article...

  14. Dissolution efficiency and bioequivalence study using urine data from healthy volunteers: a comparison between two tablet formulations of cephalexin

    Directory of Open Access Journals (Sweden)

    Cristina Helena dos Reis Serra

    2015-06-01

    Full Text Available The aim of the present study was to assess the bioequivalence of two cephalexin tablet formulations available in the Brazilian market (product A as reference formulation and product B as test formulation. Dissolution efficiency (DE% was calculated for both formulations to evaluate their in vitrobiopharmaceutical features. The oral bioequivalence study was performed in twenty-four healthy volunteers in a crossover design. Single oral dose (tablet containing 500 mg of cephalexin of each product was administered with two weeks of washout period. Urinary concentrations of cephalexin were measured by high-performance liquid chromatography (HPLC method and pharmacokinetics parameters were estimated by urinary excretion data. The bioequivalence was determined by the following parameters: the cumulative amount of cephalexin excreted in the urine, the total amount of cephalexin excreted in the urine and the maximum urinary excretion rate of cephalexin. DE values of immediate-release cephalexin tablets (500 mg were 68.69±4.18% for product A and 71.03±6.63% for product B. Regarding the dissolution test of the two brands (A and B analysed, both were in compliance with the official pharmacopeial specifications, since the dissolution of both formulations was superior to 80% of the amount declared in the label after 45 minutes of test (A=92.09%±1.84; B=92.84%±1.08. The results obtained indicated that the products A and B are pharmaceutical equivalents. Confidence intervals for the pharmacokinetic parameters were in compliance with the international standards, indicating that products A and B can be considered bioequivalents and, therefore, interchangeable.

  15. Bioequivalence of fixed-dose combination Myrin®-P Forte and reference drugs in loose combination.

    Science.gov (United States)

    Wang, H F; Wang, R; O'Gorman, M; Crownover, P; Naqvi, A; Jafri, I

    2013-12-01

    Myrin®-P Forte is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg), isoniazid (INH, 75 mg), ethambutol (EMB) hydrochloride (275 mg) and pyrazinamide (PZA, 400 mg) developed for the treatment of tuberculosis (TB). This study was conducted at a single centre--the Pfizer Clinical Research Unit in Singapore. To demonstrate the bioequivalence of each drug component of the Myrin-P Forte FDC and the individual product in loose combination. In a randomized, open-label, single-dose, two-way, crossover study, subjects received single doses of Myrin-P Forte or four individual products under fasting conditions in a crossover fashion with at least 7 days washout between doses. The primary measures for comparison were peak plasma concentration (C(max)) and the area under plasma concentration-time curve (AUC). Of 36 subjects enrolled, 35 completed the study. The adjusted geometric mean ratios and 90% confidence intervals for C(max) and AUC values were completely contained within bioequivalence limits (80%, 125%) for all four drugs in both formulations. Both treatments were generally well tolerated in the study. The Myrin-P Forte FDC tablet formulation is bioequivalent to the four single-drug references for RMP, INH, EMB hydrochloride and PZA at equivalent doses.

  16. Early Site Permit Demonstration Program: Recommendations for communication activities and public participation in the Early Site Permit Demonstration Program

    Energy Technology Data Exchange (ETDEWEB)

    1993-01-27

    On October 24, 1992, President Bush signed into law the National Energy Policy Act of 1992. The bill is a sweeping, comprehensive overhaul of the Nation`s energy laws, the first in more than a decade. Among other provisions, the National Energy Policy Act reforms the licensing process for new nuclear power plants by adopting a new approach developed by the US Nuclear Regulatory Commission (NRC) in 1989, and upheld in court in 1992. The NRC 10 CFR Part 52 rule is a three-step process that guarantees public participation at each step. The steps are: early site permit approval; standard design certifications; and, combined construction/operating licenses for nuclear power reactors. Licensing reform increases an organization`s ability to respond to future baseload electricity generation needs with less financial risk for ratepayers and the organization. Costly delays can be avoided because design, safety and siting issues will be resolved before a company starts to build a plant. Specifically, early site permit approval allows for site suitability and acceptability issues to be addressed prior to an organization`s commitment to build a plant. Responsibility for site-specific activities, including communications and public participation, rests with those organizations selected to try out early site approval. This plan has been prepared to assist those companies (referred to as sponsoring organizations) in planning their communications and public involvement programs. It provides research findings, information and recommendations to be used by organizations as a resource and starting point in developing their own plans.

  17. Early Site Permit Demonstration Program: Recommendations for communication activities and public participation in the Early Site Permit Demonstration Program

    International Nuclear Information System (INIS)

    1993-01-01

    On October 24, 1992, President Bush signed into law the National Energy Policy Act of 1992. The bill is a sweeping, comprehensive overhaul of the Nation's energy laws, the first in more than a decade. Among other provisions, the National Energy Policy Act reforms the licensing process for new nuclear power plants by adopting a new approach developed by the US Nuclear Regulatory Commission (NRC) in 1989, and upheld in court in 1992. The NRC 10 CFR Part 52 rule is a three-step process that guarantees public participation at each step. The steps are: early site permit approval; standard design certifications; and, combined construction/operating licenses for nuclear power reactors. Licensing reform increases an organization's ability to respond to future baseload electricity generation needs with less financial risk for ratepayers and the organization. Costly delays can be avoided because design, safety and siting issues will be resolved before a company starts to build a plant. Specifically, early site permit approval allows for site suitability and acceptability issues to be addressed prior to an organization's commitment to build a plant. Responsibility for site-specific activities, including communications and public participation, rests with those organizations selected to try out early site approval. This plan has been prepared to assist those companies (referred to as sponsoring organizations) in planning their communications and public involvement programs. It provides research findings, information and recommendations to be used by organizations as a resource and starting point in developing their own plans

  18. The impact of interventions to promote physical activity in urban green space: a systematic review and recommendations for future research.

    Science.gov (United States)

    Hunter, Ruth F; Christian, Hayley; Veitch, Jenny; Astell-Burt, Thomas; Hipp, J Aaron; Schipperijn, Jasper

    2015-01-01

    Evidence is mounting on the association between the built environment and physical activity (PA) with a call for intervention research. A broader approach which recognizes the role of supportive environments that can make healthy choices easier is required. A systematic review was undertaken to assess the effectiveness of interventions to encourage PA in urban green space. Five databases were searched independently by two reviewers using search terms relating to 'physical activity', 'urban green space' and 'intervention' in July 2014. Eligibility criteria included: (i) intervention to encourage PA in urban green space which involved either a physical change to the urban green space or a PA intervention to promote use of urban green space or a combination of both; and (ii) primary outcome of PA. Of the 2405 studies identified, 12 were included. There was some evidence (4/9 studies showed positive effect) to support built environment only interventions for encouraging use and increasing PA in urban green space. There was more promising evidence (3/3 studies showed positive effect) to support PAprograms or PA programs combined with a physical change to the built environment, for increasing urban green space use and PA of users. Recommendations for future research include the need for longer term follow-up post-intervention, adequate control groups, sufficiently powered studies, and consideration of the social environment, which was identified as a significantly under-utilized resource in this area. Interventions that involve the use of PA programs combined with a physical change to the built environment are likely to have a positive effect on PA. Robust evaluations of such interventions are urgently required. The findings provide a platform to inform the design, implementation and evaluation of future urban green space and PAintervention research. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Recommender systems

    CERN Document Server

    Kembellec, Gérald; Saleh, Imad

    2014-01-01

    Acclaimed by various content platforms (books, music, movies) and auction sites online, recommendation systems are key elements of digital strategies. If development was originally intended for the performance of information systems, the issues are now massively moved on logical optimization of the customer relationship, with the main objective to maximize potential sales. On the transdisciplinary approach, engines and recommender systems brings together contributions linking information science and communications, marketing, sociology, mathematics and computing. It deals with the understan

  20. A pharmacokinetic and bioequivalence study of Contiflo ICON 400 µg tablets in healthy Indian subjects.

    Science.gov (United States)

    Monif, T; Arora, V; Madan, S; Arora, R; Balaji, A; Jha, D; Thudi, N R

    2010-12-01

    Tamsulosin, an alpha1 adrenoceptor blocking agent, exhibits selectivity for alpha1 receptors in human prostate. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of benign prostatic hypertrophy. A new formulation Contiflo ICON 400 µg has been developed by Ranbaxy Laboratories Limited, India similar to Flomaxtra XL 400 µg of Astellas Pharma Limited, United Kingdom. This product is specifically designed to achieve a more consistent plasma concentration over a period of 24-h, a lower maximum plasma concentration (Cmax) and an independence of pharmacokinetics (PKs) on food intake. The objective of the present study was to evaluate the pharmacokinetics and bioequivalence of the new formulation Contiflo ICON 400 µg of Ranbaxy Laboratories Limited, India and Flomaxtra XL 400 µg prolonged release tablets (containing tamsulosin hydrochloride prolonged release 400 µg) of Astellas Pharma Limited, United Kingdom. Study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, cross over, single-dose bioequivalence study in 32 adult male human subjects under fed conditions. The mean (range) age, weight and height of the study subjects were 27.03 years (19 - 40 years), 57.19 kg (48 - 72 kg) and 166.81 cm (154 - 181 cm) respectively. Blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 20, 24, 36, 48, 72, and 96 h post dose in each period. Plasma samples were analyzed for tamsulosin by using validated liquid chromatographic mass spectrometry (LC-MS/MS) method. The Mean ± SD of pharmacokinetic parameters tmax, Cmax, AUC24, AUClast and AUCinf for Tamsulosin were 11.741 ± 4.7201 and 12.155 ± 6.3077 h, 10.7614 ± 4.76709 and 10.4954 ± 5.08979 ng/ml, 171.4674 ± 77.39695 and 160.6738 ± 77.98628 ng.h/ml, 262.7771 ± 150.21432 and 250.6854 ± 156.75581 ng

  1. Bioequivalence study of a generic Risperidone (Iperdal® in healthy Thai male volunteers

    Directory of Open Access Journals (Sweden)

    Werawath Mahatthanatrakul

    2008-05-01

    Full Text Available The objective of this study was to compare the rate and extent of absorption of a generic risperidone (Iperdal® with a reference formulation (Risperdal® when given orally. The study was an open label, randomized, two-period, two-sequence,single dose cross-over design with a 2 weeks washout period in 16 healthy Thai male volunteers. Single oral dose of two 2-mg tablets of risperidone were administered and serial blood samples were collected from the antecubital vein before and at0.17, 0.33, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 and 48 hours post dose. Risperidone plasma concentrations were assayed using a validated High Performance Liquid Chromatographic (HPLC-UV method modified from Avenosoet al. (2000. Pharamcokinetic parameters i.e. Cmax, AUC0à48 and Tmax were analyzed by noncompartment analysis. Variations of the data were analyzed by “Two Way Analysis of Variance” (ANOVA. Statistics were tested as stated in USP 28 guidelinefor bioequivalence study. The maximum concentration (Cmax, ng/ml of risperidone for the innovator and the generic product were 31.11±17.24 (range 5.64-56.78 and 32.58±19.77 (range 5.29-84.56 ng/ml, respectively. The area under theplasma concentration-time curve (AUC0®48 of the innovator and the generic product were 160.64±152.89 (range 18.57- 550.32 and 144.03±127.37 (range 16.27-456.0 ng.hr/ml, respectively. The time to maximum concentration (Tmax of theinnovator and the generic product were 0.97±0.41(range 0.5-2 and 1.02±0.32 (range 0.5-1.5 hr, respectively. The 90% confidence interval of the ratio of the ln-transformed of Cmax and AUC0à48 of both preparations were 89.39-112.99% and80.02-107.28% respectively which were within the acceptance range of 80.00-125.00%. Therefore, it can be concluded that both preparations used in this study are bioequivalent in terms of both the rate and extent of absorption.

  2. Sport Activity for Health!! The Effects of Karate Participants' Involvement, Perceived Value, and Leisure Benefits on Recommendation Intention.

    Science.gov (United States)

    Chang, Ying-Chih; Yeh, Tsu-Ming; Pai, Fan-Yun; Huang, Tai-Peng

    2018-05-10

    This study intends to discuss the effects of participants’ involvement, perceived value, and leisure benefits on recommendation intention in the sport of karate. The questionnaires were collected online by karate clubs on Facebook and included 369 valid participants. The research findings show that karate participants from different places of residence do not display significant differences in involvement, perceived value, leisure benefits, and recommendation intention. Furthermore, “attraction” in the involvement category reveals the highest mean, “paid spirit and energy being worthy” in perceived value appears as the highest mean, and “physiological benefits” in leisure benefits shows the highest mean. The Pearson correlation analysis result presents significant strong positive correlations between involvement, perceived value, leisure benefits, and recommendation intention. Finally, multiple regression analysis reveals that leisure benefits, except “physiological benefits”, show notably positive effects on recommendation intention. According to the research results, suggestions are proposed for the reference of karate teaching business managers, participants, and future research.

  3. Too Fit To Fracture: outcomes of a Delphi consensus process on physical activity and exercise recommendations for adults with osteoporosis with or without vertebral fractures.

    Science.gov (United States)

    Giangregorio, L M; McGill, S; Wark, J D; Laprade, J; Heinonen, A; Ashe, M C; MacIntyre, N J; Cheung, A M; Shipp, K; Keller, H; Jain, R; Papaioannou, A

    2015-03-01

    An international consensus process resulted in exercise and physical activity recommendations for individuals with osteoporosis. Emphasis was placed on strength, balance, and postural alignment. Rather than providing generic restrictions, activity should be encouraged while considering impairments, fracture risk, activity history, and preference, and guidance on spine sparing techniques should be provided. The objectives of this study were to establish expert consensus on key questions posed by patients or health care providers regarding recommended assessment domains to inform exercise prescription, therapeutic goals of exercise, and physical activity and exercise recommendations for individuals with osteoporosis or osteoporotic vertebral fracture. The Too Fit To Fracture expert panel identified researchers and clinicians with expertise in exercise and osteoporosis and stakeholder groups. We delivered a modified online Delphi survey (two rounds) to establish consensus on assessment, exercise, and physical activities for three cases with varying risk (osteoporosis based on bone mineral density; 1 spine fracture and osteoporosis; multiple spine fractures, osteoporosis, hyperkyphosis, and pain). Duplicate content analyses of free text responses were performed. Response rates were 52% (39/75) and 69% (48/70) for each round. Key consensus points are the following: (a) Current physical activity guidelines are appropriate for individuals with osteoporosis without spine fracture, but not for those with spine fracture; (b) after spine fracture, physical activity of moderate intensity is preferred to vigorous; (c) daily balance training and endurance training for spinal extensor muscles are recommended for all; (d) providing guidance on spine-sparing techniques (e.g., hip hinge) during activities of daily living or leisure, considering impairments, fracture risk, activity history, and preference, is recommended rather than providing generic restrictions (e.g., lifting <10

  4. Sport Activity for Health!! The Effects of Karate Participants’ Involvement, Perceived Value, and Leisure Benefits on Recommendation Intention

    OpenAIRE

    Ying-Chih Chang; Tsu-Ming Yeh; Fan-Yun Pai; Tai-Peng Huang

    2018-01-01

    This study intends to discuss the effects of participants’ involvement, perceived value, and leisure benefits on recommendation intention in the sport of karate. The questionnaires were collected online by karate clubs on Facebook and included 369 valid participants. The research findings show that karate participants from different places of residence do not display significant differences in involvement, perceived value, leisure benefits, and recommendation intention. Furthermore, &ld...

  5. Analysis of Intra- and Intersubject Variability in Oral Drug Absorption in Human Bioequivalence Studies of 113 Generic Products.

    Science.gov (United States)

    Sugihara, Masahisa; Takeuchi, Susumu; Sugita, Masaru; Higaki, Kazutaka; Kataoka, Makoto; Yamashita, Shinji

    2015-12-07

    In this study, the data of 113 human bioequivalence (BE) studies of immediate release (IR) formulations of 74 active pharmaceutical ingredients (APIs) conducted at Sawai Pharmaceutical Co., Ltd., was analyzed to understand the factors affecting intra- and intersubject variabilities in oral drug absorption. The ANOVA CV (%) calculated from area under the time-concentration curve (AUC) in each BE study was used as an index of intrasubject variability (Vintra), and the relative standard deviation (%) in AUC was used as that of intersubject variability (Vinter). Although no significant correlation was observed between Vintra and Vinter of all drugs, Vintra of class 3 drugs was found to increase in association with a decrease in drug permeability (P(eff)). Since the absorption of class 3 drugs was rate-limited by the permeability, it was suggested that, for such drugs, the low P(eff) might be a risk factor to cause a large intrasubject variability. To consider the impact of poor water solubility on the variability in BE study, a parameter of P(eff)/Do (Do; dose number) was defined to discriminate the solubility-limited and dissolution-rate-limited absorption of class 2 drugs. It was found that the class 2 drugs with a solubility-limited absorption (P(eff)/Do high intrasubject variability. Furthermore, as a reason for high intra- or intersubject variability in AUC for class 1 drugs, effects of drug metabolizing enzymes were investigated. It was demonstrated that intrasubject variability was high for drugs metabolized by CYP3A4 while intersubject variability was high for drugs metabolized by CYP2D6. For CYP3A4 substrate drugs, the Km value showed the significant relation with Vintra, indicating that the affinity to the enzyme can be a parameter to predict the risk of high intrasubject variability. In conclusion, by analyzing the in house data of human BE study, low permeability, solubility-limited absorption, and high affinity to CYP3A4 are identified as risk factors for

  6. Recommender Systems for Learning

    CERN Document Server

    Manouselis, Nikos; Verbert, Katrien; Duval, Erik

    2013-01-01

    Technology enhanced learning (TEL) aims to design, develop and test sociotechnical innovations that will support and enhance learning practices of both individuals and organisations. It is therefore an application domain that generally covers technologies that support all forms of teaching and learning activities. Since information retrieval (in terms of searching for relevant learning resources to support teachers or learners) is a pivotal activity in TEL, the deployment of recommender systems has attracted increased interest. This brief attempts to provide an introduction to recommender systems for TEL settings, as well as to highlight their particularities compared to recommender systems for other application domains.

  7. [Bioequivalence of dermatological topical medicines:the Brazilian scenario and the challenges for health surveillance].

    Science.gov (United States)

    Soares, Kelen Carine Costa; Moraes, Marcelo Vogler; Gelfuso, Guilherme Martins; Gratieri, Taís

    2015-11-01

    The comparative evaluation required for the registration of generic topical medicines in Brazil is conducted by means of a pharmaceutical equivalence study, which merely assesses the physical/chemical and microbiological parameters of the formulations. At the international level, clinical or pharmacodynamic studies are now being required to prove the efficacy and safety of semisolid topical generic formulations. This work presents a comparison of the different requirements for the registration of topical formulations, taking into consideration the various regulatory authorities, and presents a survey of topical medicines registered in Brazil prior to 2013. The survey revealed that in comparison with the USA there were many more copies of these formulations registered in Brazil. This fact, together with the large number of studies in the literature showing the lack of bioequivalence of topical medication, is clear proof of the major importance of the need to realign Brazilian legislation with respect to the technical requirements for the registration of generic and similar medication for dermatological topical application in Brazil.

  8. Use of partial AUC (PAUC) to evaluate bioequivalence--a case study with complex absorption: methylphenidate.

    Science.gov (United States)

    Fourie Zirkelbach, Jeanne; Jackson, Andre J; Wang, Yaning; Schuirmann, Donald J

    2013-01-01

    Methylphenidate modified-release products produce early and late peak concentrations critical for treatment of morning and afternoon symptoms of attention deficit hyperactivity disorder (ADHD). Standard bioequivalence (BE) criteria cannot be applied to these products. The performance of partial area under the drug concentration-time curve (PAUC), Cmax and AUCINF to assess BE were independently evaluated for two products. A two-stage analysis was performed on plasma data for two methylphenidate modified-release products (Product 1 and 2). Simulations using the fitted parameters determined how changes in fast absorption rate constant (K0Fast) and fraction available (F1) affected curve shape and BE determination using Cmax, AUCINF and PAUC. The sensitivity of the mean PAUC(test)/PAUC(reference) ratios to changes in K0Fast(test) are product dependent. Product 1 mean PAUC(test)/PAUC(reference) ratios for PAUC0-4h are more responsive to both decreases and increases in K0Fast(test) than Product 2. Product 2 showed a greater response in the mean PAUC(test)/PAUC(reference) ratio for PAUC0-4h when the K0Fast(test) is decreased and less response as the value is increased. PAUC estimated curve shape is sensitive to changes in absorption and are product specific, and may require a new PAUC metric for each drug. A non-product specific metric to assess curve shape is warranted.

  9. Perceived success/failure and attributions associated with self-regulatory efficacy to meet physical activity recommendations for women with arthritis.

    Science.gov (United States)

    Spink, Kevin S; Brawley, Lawrence R; Gyurcsik, Nancy C

    2016-10-01

    The relationship between attributional dimensions women assign to the cause of their perceived success or failure at meeting the recommended physical activity dose and self-regulatory efficacy for future physical activity was examined among women with arthritis. Women (N = 117) aged 18-84 years, with self-reported medically-diagnosed arthritis, completed on-line questions in the fall of 2013 assessing endurance physical activity, perceived outcome for meeting the recommended levels of endurance activity, attributions for one's success or failure in meeting the recommendations, and self-regulatory efficacy to schedule/plan endurance activity over the next month. The main theoretically-driven finding revealed that the interaction of the stability dimension with perceived success/failure was significantly related to self-regulatory efficacy for scheduling and planning future physical activity (β = 0.35, p = .002). Outcomes attributed to more versus less stable factors accentuated differences in self-regulatory efficacy beliefs following perceived success and failure at being active. It appears that attributional dimensions were associated with self-regulatory efficacy in women with arthritis. This suggests that rather than objectively observed past mastery experience, women's subjective perceptions and explanations of their past experiences were related to efficacy beliefs, especially following a failure experience.

  10. Trend study electricity 2022. Meta studies analysis and activity recommendations. dena report; Trendstudie Strom 2022. Metastudienanalyse und Handlungsempfehlungen. dena-Berichtsteil

    Energy Technology Data Exchange (ETDEWEB)

    Peters, Sebastian; Teichmann, Mario; Voelker, Jakob; Weber, Andreas

    2013-03-07

    The dena report concerning the trend study electricity 2022 covers the following issues: (I) aim of the project - methodology; (II) qualitative analysis of studies on the development of the energy system in Germany (meta analysis); (III) comparison of results and activity recommendations: energy demand and energy efficiency, renewable energies, conventional energies, grids, energy storage, electricity market design, European aspects; roadmap.

  11. Parents’ Perceptions and Adherence to Children’s Diet and Activity Recommendations: the 2008 Feeding Infants and Toddlers Study

    Science.gov (United States)

    Deming, Denise M.; Reidy, Kathleen C.

    2015-01-01

    Introduction Solving the childhood obesity problem will require strategies for changes in policy, the environment, the community, and the family. Filling the data gap for children younger than 4 years could facilitate interventions aimed at this critical age group. The objective of this study was to describe parents’ and caregivers’ perceptions of the healthfulness of their young child’s diet and body weight and to assess their adherence to the American Academy of Pediatrics’ 5-2-1-0 recommendations. Methods We conducted a descriptive analysis of parents’ and caregivers’ survey data for 887 infants younger than 12 months, 925 toddlers aged 12 to 23.9 months, and 1,461 preschoolers aged 24 to 47.9 months. Data were from the national, cross-sectional 2008 Feeding Infants and Toddlers Study (FITS). Results Most parents considered their child’s weight to be about right but were more likely to think their child was underweight (8%–9%) than overweight (2%–3%). Most parents thought their child consumed enough fruits and vegetables: however, only 30% of preschoolers met the recommendation for 5 daily servings. Only 2% of toddlers met the recommendation for no screen time, whereas 79% of preschoolers met the recommendation to limit daily screen time to 2 hours or less. About 56% of toddlers and 71% of preschoolers met the recommendation of at least 1 hour of daily outdoor play. About 56% of toddlers and 52% of preschoolers met the recommendation to limit consumption of sugar-sweetened beverages. Conclusion The FITS 2008 findings underscore the ongoing need for research on policies and strategies to prevent childhood obesity from infancy through preschool. Health care providers can play a vital role because they are an important and early point of contact for parents. PMID:26402049

  12. Advantages of automation in plasma sample preparation prior to HPLC/MS/MS quantification: application to the determination of cilazapril and cilazaprilat in a bioequivalence study.

    Science.gov (United States)

    Kolocouri, Filomila; Dotsikas, Yannis; Apostolou, Constantinos; Kousoulos, Constantinos; Soumelas, Georgios-Stefanos; Loukas, Yannis L

    2011-01-01

    An HPLC/MS/MS method characterized by complete automation and high throughput was developed for the determination of cilazapril and its active metabolite cilazaprilat in human plasma. All sample preparation and analysis steps were performed by using 2.2 mL 96 deep-well plates, while robotic liquid handling workstations were utilized for all liquid transfer steps, including liquid-liquid extraction. The whole procedure was very fast compared to a manual procedure with vials and no automation. The method also had a very short chromatographic run time of 1.5 min. Sample analysis was performed by RP-HPLC/MS/MS with positive electrospray ionization using multiple reaction monitoring. The calibration curve was linear in the range of 0.500-300 and 0.250-150 ng/mL for cilazapril and cilazaprilat, respectively. The proposed method was fully validated and proved to be selective, accurate, precise, reproducible, and suitable for the determination of cilazapril and cilazaprilat in human plasma. Therefore, it was applied to a bioequivalence study after per os administration of 2.5 mg tablet formulations of cilazapril.

  13. Sport Activity for Health!! The Effects of Karate Participants’ Involvement, Perceived Value, and Leisure Benefits on Recommendation Intention

    Science.gov (United States)

    Chang, Ying-Chih; Pai, Fan-Yun; Huang, Tai-Peng

    2018-01-01

    This study intends to discuss the effects of participants’ involvement, perceived value, and leisure benefits on recommendation intention in the sport of karate. The questionnaires were collected online by karate clubs on Facebook and included 369 valid participants. The research findings show that karate participants from different places of residence do not display significant differences in involvement, perceived value, leisure benefits, and recommendation intention. Furthermore, “attraction” in the involvement category reveals the highest mean, “paid spirit and energy being worthy” in perceived value appears as the highest mean, and “physiological benefits” in leisure benefits shows the highest mean. The Pearson correlation analysis result presents significant strong positive correlations between involvement, perceived value, leisure benefits, and recommendation intention. Finally, multiple regression analysis reveals that leisure benefits, except “physiological benefits”, show notably positive effects on recommendation intention. According to the research results, suggestions are proposed for the reference of karate teaching business managers, participants, and future research. PMID:29748459

  14. Should Physical Activity Recommendations for South Asian Adults Be Ethnicity-Specific? Evidence from a Cross-Sectional Study of South Asian and White European Men and Women.

    Science.gov (United States)

    Iliodromiti, Stamatina; Ghouri, Nazim; Celis-Morales, Carlos A; Sattar, Naveed; Lumsden, Mary Ann; Gill, Jason M R

    2016-01-01

    International public health guidelines recommend that adults undertake at least 150 min.week-1 of moderate-intensity physical activity. However, the underpinning evidence has largely been obtained from studies of populations of white European descent. It is unclear whether these recommendations are appropriate for other ethnic groups, particularly South Asians, who have greater cardio-metabolic risk than white Europeans. The objective of our study was to determine the level of moderate-intensity physical activity required in South Asians adults to confer a similar cardio-metabolic risk profile to that observed in Europeans of similar age and body mass index (BMI) undertaking the currently recommended levels of 150 min.week-1. 148 South Asians and 163 white Europeans aged 18 to 70 years were recruited. Physical activity was measured objectively via vertical axis accelerations from hip-worn accelerometers. Factor analysis was used to summarize the measured risk biomarkers into a single underlying latent "factor" describing overall cardio-metabolic risk. Sex did not modify the association between physical activity and the cardio-metabolic risk factor, so data for both sexes were combined and models adjusted for age, sex, BMI and accelerometer wear time. We estimated that South Asian adults needed to undertake 232 (95% Confidence interval: 200 to 268) min.week-1 in order to obtain the same cardio-metabolic risk factor score as a white European undertaking 150 minutes of moderate-equivalent physical activity per week. The present findings suggest that South Asian men and women need to undertake ~230 minutes of moderate intensity physical activity per week. This equates to South Asians undertaking an extra 10-15 minutes of moderate intensity physical activity per day on top of existing recommendations.

  15. Should Physical Activity Recommendations for South Asian Adults Be Ethnicity-Specific? Evidence from a Cross-Sectional Study of South Asian and White European Men and Women.

    Directory of Open Access Journals (Sweden)

    Stamatina Iliodromiti

    Full Text Available International public health guidelines recommend that adults undertake at least 150 min.week-1 of moderate-intensity physical activity. However, the underpinning evidence has largely been obtained from studies of populations of white European descent. It is unclear whether these recommendations are appropriate for other ethnic groups, particularly South Asians, who have greater cardio-metabolic risk than white Europeans. The objective of our study was to determine the level of moderate-intensity physical activity required in South Asians adults to confer a similar cardio-metabolic risk profile to that observed in Europeans of similar age and body mass index (BMI undertaking the currently recommended levels of 150 min.week-1. 148 South Asians and 163 white Europeans aged 18 to 70 years were recruited. Physical activity was measured objectively via vertical axis accelerations from hip-worn accelerometers. Factor analysis was used to summarize the measured risk biomarkers into a single underlying latent "factor" describing overall cardio-metabolic risk. Sex did not modify the association between physical activity and the cardio-metabolic risk factor, so data for both sexes were combined and models adjusted for age, sex, BMI and accelerometer wear time. We estimated that South Asian adults needed to undertake 232 (95% Confidence interval: 200 to 268 min.week-1 in order to obtain the same cardio-metabolic risk factor score as a white European undertaking 150 minutes of moderate-equivalent physical activity per week. The present findings suggest that South Asian men and women need to undertake ~230 minutes of moderate intensity physical activity per week. This equates to South Asians undertaking an extra 10-15 minutes of moderate intensity physical activity per day on top of existing recommendations.

  16. Bioequivalence of a fixed-dose repaglinide/metformin combination tablet and equivalent doses of repaglinide and metformin tablets
.

    Science.gov (United States)

    Cho, Hea-Young; Ngo, Lien; Kim, Sang-Ki; Choi, Yoonho; Lee, Yong-Bok

    2018-06-01

    This study was conducted to determine whether a fixed-dose combination (FDC) tablet of repaglinide/metformin (2/500 mg) is equivalent to coadministration of equivalent doses of individual (EDI) tablets of repaglinide (2 mg) and metformin (500 mg) in healthy Korean male subjects. This study was conducted as an open-label, randomized, single-dose, two-period, two-sequence crossover design in 50 healthy Korean male subjects who received an FDC tablet or EDI tablets. Plasma concentrations of repaglinide and metformin were determined for up to 24 hours using a validated UPLC-MS/MS method. Bioequivalence was assessed according to current guidelines issued by the U.S. Food and Drug Administration (FDA) and Korean legislation. Tolerability was also evaluated throughout the study via subject interview, vital signs, and blood sampling. Point estimates (90% CIs) for AUC0-t, AUC0-∞, and Cmax based on EDI tablets were 110.07 (102.25 - 118.49), 109.90 (101.70 - 118.39), and 112.60 (101.49 - 124.85), respectively, for repaglinide. They were 95.18 (89.62 - 101.05), 95.00 (89.74 - 100.65), and 98.44 (92.72 - 104.50), respectively, for metformin. These results satisfied the bioequivalence criteria of 80.00 - 125.00% proposed by the FDA and Korean legislation. Results of pharmacokinetic analysis suggested that repaglinide and metformin in FDC tablets were bioequivalent to EDI tablets of repaglinide (2 mg) and metformin (500 mg) in healthy Korean male subjects. Both formulations appeared to be well tolerated.
.

  17. A single dose, randomized, open-label, cross-over bioequivalence study of sildenafil citrate tablets in healthy Chinese volunteers
.

    Science.gov (United States)

    Li, Dai; Wang, Yu-Lu; Xu, Su-Mei; Li, Dan; Li, Xiao-Min; Pan, Jing; Xu, Ping-Sheng

    2017-02-01

    The present study was designed to evaluate the bioequivalence of a newly developed sildenafil citrate tablet 50 mg (Jinge®, Test) and a marketed counterpart (Viagra®, 100 mg, Reference) in healthy adult male Chinese volunteers. This single-dose, randomized, open-label, four-period, and two-treatment self-crossover study included two parts: fasting and postprandial studies. In each part of the study, the subjects were randomly assigned to receive test or reference products (100 mg sildenafil) in a 1 : 1 ratio, and then received the alternative products, following a 1-week washout period. Plasma sildenafil concentrations were analyzed by liquid chromatography-tandem mass spectrometry. Tolerability was assessed during the entire study period. 32 healthy volunteers (aged 19 - 30) were enrolled in the study; 31 volunteers completed the fasting study, while 32 volunteers completed the postprandial study. The test formulation was bioequivalent to the marketed formulation as the 90% CIs for the ratio of geometric means of Cmax (fasting: 98.79 - 119.61%; fed: 94.47 - 119.65%), AUClast (fasting: 98.70 - 109.71%; fed: 96.39 - 112.89%), and AUC∞ (fasting: 98.45 - 108.87%; fed: 96.36 - 112.74%) were within equivalence limits (80 - 125%) under both fasting and postprandial conditions. When sildenafil was given with high-fat meals, mean Cmax was reduced by 23%, and median tmax ranged from 0.75 to 1.50 hours (p ≤ 0.05). However, both AUClast and AUC∞ were comparable between fasting and postprandial conditions. No serious adverse events were found among the subjects. This study confirmed that test and reference sildenafil citrate tablets were bioequivalent under fasting and postprandial conditions.
.

  18. Pharmaceutical Product Lead Optimization for Better In vivo Bioequivalence Performance: A case study of Diclofenac Sodium Extended Release Matrix Tablets.

    Science.gov (United States)

    Shahiwala, Aliasgar; Zarar, Aisha

    2018-01-01

    In order to prove the validity of a new formulation, a considerable amount of effort is required to study bioequivalence, which not only increases the burden of carrying out a number of bioequivalence studies but also eventually increases the cost of the optimization process. The aim of the present study was to develop sustained release matrix tablets containing diclofenac sodium using natural polymers and to demonstrate step by step process of product development till the prediction of in vivo marketed product equivalence of the developed product. Different batches of tablets were prepared by direct compression. In vitro drug release studies were performed as per USP. The drug release data were assessed using model-dependent, modelindependent and convolution approaches. Drug release profiles showed that extended release action were in the following order: Gum Tragacanth > Sodium Alginate > Gum Acacia. Amongst the different batches prepared, only F1 and F8 passed the USP criteria of drug release. Developed formulas were found to fit Higuchi kinetics model with Fickian (case I) diffusion-mediated release mechanism. Model- independent kinetics confirmed that total of four batches were passed depending on the similarity factors based on the comparison with the marketed Diclofenac. The results of in vivo predictive convolution model indicated that predicted AUC, Cmax and Tmax values for batch F8 were similar to that of marketed product. This study provides simple yet effective outline of pharmaceutical product development process that will minimize the formulation development trials and maximize the product success in bioequivalence studies. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  19. The impact of new partial AUC parameters for evaluating the bioequivalence of prolonged-release formulations.

    Science.gov (United States)

    Boily, Michaël; Dussault, Catherine; Massicotte, Julie; Guibord, Pascal; Lefebvre, Marc

    2015-01-23

    To demonstrate bioequivalence (BE) between two prolonged-release (PR) drug formulations, single dose studies under fasting and fed state as well as at least one steady-state study are currently required by the European Medicines Agency (EMA). Recently, however, there have been debates regarding the relevance of steady-state studies. New requirements in single-dose investigations have also been suggested by the EMA to address the absence of a parameter that can adequately assess the equivalence of the shape of the curves. In the draft guideline issued in 2013, new partial area under the curve (pAUC) pharmacokinetic (PK) parameters were introduced to that effect. In light of these potential changes, there is a need of supportive clinical evidence to evaluate the impact of pAUCs on the evaluation of BE between PR formulations. In this retrospective analysis, it was investigated whether the newly defined parameters were associated with an increase in discriminatory ability or a change in variability compared to the conventional PK parameters. Among the single dose studies that met the requirements already in place, 20% were found unable to meet the EMA's new requirements in regards to the pAUC PK parameters. When pairing fasting and fed studies for a same formulation, the failure rate increased to 40%. In some cases, due to the high variability of these parameters, an increase of the sample size would be required to prove BE. In other cases however, the pAUC parameters demonstrated a robust ability to detect differences between the shapes of the curves of PR formulations. The present analysis should help to better understand the impact of the upcoming changes in European regulations on PR formulations and in the design of future BE studies. Copyright © 2014 Elsevier B.V. All rights reserved.

  20. Pharmacokinetic and bioequivalence study of two brands of valsartan tablets in healthy male volunteers.

    Science.gov (United States)

    Zakeri-Milani, Parvin; Valizadeh, Hadi; Islambulchilar, Ziba; Nemati, Mahboob

    2010-01-01

    Valsartan (CAS 137862-53-4) is an antihypertensive drug belonging to the family of angiotensin II receptor antagonists acting at the AT1 receptor, which mediates all known effects of angiotensin II on the cardiovascular system. In the present study, the pharmacokinetic parameters of two oral formulations of valsartan tablets were compared in a randomized, single oral dose, two-treatment crossover design in 24 healthy male volunteers under fasting conditions. After an overnight fast, the volunteers received 80 mg valsartan. Blood samples were collected up to 48 h and drug concentrations were determined by a reverse-phase HPLC method with fluorescence detection. Various pharmacokinetic parameters were determined from the plasma concentration-time curves of both formulations. The obtained values for test and reference products were 3067.7 +/- 1,281.7 and 3,304.3 +/- 1,196.4 ng/ml for Cmax; 17,834.4 +/- 7,083.8 and 18,319.1 +/- 7,800.7 ng x h/ml for AUC0-48; 18,825.7 +/- 7,553.2 and 19,172.2 +/- 8,307.2 ng x h/ml for AUC0-infinity, respectively. The 90% confidence intervals obtained by analysis of variance were 86.84-100.87% for Cmax and 93.43-115.54% for AUC0-t, which are within the acceptance range of 80-125%. Therefore it can be concluded that both products are bioequivalent in terms of rate and extent of drug absorption and therefore interchangeable.

  1. Report and recommendations of the task force on tree and shrub planting on active oil sands tailings dams

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-02-15

    In oil sands reclamation operations in Canada there is a conflict between dam safety and the planting of trees and woody shrubs. Indeed, tree planting is being restricted on the downstream slopes of dams to avoid damage to drains and to ensure the integrity of visual and instrumentation monitoring conflicting thus with progressive reclamation. Alberta Environment hired the Oil Sands Research and Information Network (OSRIN), an independent organization which analyzes and interprets available knowledge on soil and water reclamation in the oil sands mining sector, to address this issue and make recommendations. The organization appointed a Task Force which presented its final report in March 2011. The Task Force recommended that the Engineer of Record should be responsible for determining the tree and shrub planting zones and that he should submit his plans to Alberta Environment for approval.

  2. Recommendations for Assessment of the Reliability, Sensitivity, and Validity of Data Provided by Wearable Sensors Designed for Monitoring Physical Activity.

    Science.gov (United States)

    Düking, Peter; Fuss, Franz Konstantin; Holmberg, Hans-Christer; Sperlich, Billy

    2018-04-30

    Although it is becoming increasingly popular to monitor parameters related to training, recovery, and health with wearable sensor technology (wearables), scientific evaluation of the reliability, sensitivity, and validity of such data is limited and, where available, has involved a wide variety of approaches. To improve the trustworthiness of data collected by wearables and facilitate comparisons, we have outlined recommendations for standardized evaluation. We discuss the wearable devices themselves, as well as experimental and statistical considerations. Adherence to these recommendations should be beneficial not only for the individual, but also for regulatory organizations and insurance companies. ©Peter Düking, Franz Konstantin Fuss, Hans-Christer Holmberg, Billy Sperlich. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 30.04.2018.

  3. Bioequivalence and pharmacokinetic evaluation of two formulations of risperidone 2 mg : an open-label, single-dose, fasting, randomized-sequence, two-way crossover study in healthy male Chinese volunteers.

    Science.gov (United States)

    Liu, Yun; Zhang, Meng-qi; Jia, Jing-ying; Liu, Yan-mei; Liu, Gang-yi; Li, Shui-jun; Wang, Wei; Weng, Li-ping; Yu, Chen

    2013-03-01

    Risperidone is a benzisoxazole derivate and is effective in the treatment of schizophrenia and other psychiatric illnesses in adults and children. Although there are a few reports in the literature regarding the pharmacokinetic characteristics of risperidone, insufficient data on its pharmacokinetic properties in a Chinese population are available. To meet the requirements for marketing a new generic product, this study was designed to compare the pharmacokinetic properties and bioequivalence of two 2 mg tablet formulations of risperidone: a newly developed generic formulation (test) and a branded formulation (reference) in healthy adult male Chinese volunteers. A single-dose, open-label, randomized-sequence, 2 × 2 crossover study was conducted in fasted healthy male Chinese volunteers. Eligible participants were randomly assigned in a 1:1 ratio to receive 1 tablet (2 mg each) of the test formulation (Risperidone tablet; Dr. Reddy's Laboratories Ltd., Hyderabad, India) or the reference formulation (Risperdal(®) tablet; Xian-Janssen Pharmaceutical Ltd., Xi-an, China), followed by a 2-week washout period and subsequent administration of the alternate formulation. The study drugs were administered after a 10-hour overnight fast. Plasma samples were collected over 96 hours. Plasma concentrations of the parent drug, risperidone, and its active metabolite, 9-hydroxy-risperidone, were analyzed by a liquid chromatography-tandem mass spectrometry method. The formulations would be considered bioequivalent if the 90% confidence intervals (CIs) of the natural log-transformed values were within the predetermined 80-125% equivalence range for the maximum plasma drug concentration (Cmax) and the area under the plasma concentration-time curve (AUC), in accordance with guidelines issued by the US Food and Drug Administration. Assessment of tolerability was based on recording of adverse events (AEs), monitoring of vital signs, electrocardiograms, and laboratory tests at baseline

  4. Using a single tablet daily to treat latent tuberculosis infection in Brazil: bioequivalence of two different isoniazid formulations (300 mg and 100 mg) demonstrated by a sensitive and rapid high-performance liquid chromatography-tandem mass spectrometry method in a randomised, crossover study.

    Science.gov (United States)

    Daher, André; Pitta, Luciana; Santos, Tereza; Barreira, Draurio; Pinto, Douglas

    2015-06-01

    The recommended treatment for latent tuberculosis (TB) infection in adults is a daily dose of isoniazid (INH) 300 mg for six months. In Brazil, INH was formulated as 100 mg tablets. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested a new 300 mg INH formulation. The aim of our study was to compare the bioavailability of the new INH 300 mg formulation and three 100 mg tablets of the reference formulation. We conducted a randomised, single dose, open label, two-phase crossover bioequivalence study in 28 healthy human volunteers. The 90% confidence interval for the INH maximum concentration of drug observed in plasma and area under the plasma concentration vs. time curve from time zero to the last measurable concentration "time t" was 89.61-115.92 and 94.82-119.44, respectively. The main limitation of our study was that neither adherence nor the safety profile of multiple doses was evaluated. To determine the level of INH in human plasma, we developed and validated a sensitive, simple and rapid high-performance liquid chromatography-tandem mass spectrometry method. Our results showed that the new formulation was bioequivalent to the 100 mg reference product. This finding supports the use of a single 300 mg tablet daily strategy to treat latent TB. This new formulation may increase patients' adherence to the treatment and quality of life.

  5. Using a single tablet daily to treat latent tuberculosis infection in Brazil: bioequivalence of two different isoniazid formulations (300 mg and 100 mg demonstrated by a sensitive and rapid high-performance liquid chromatography-tandem mass spectrometry method in a randomised, crossover study

    Directory of Open Access Journals (Sweden)

    André Daher

    2015-06-01

    Full Text Available The recommended treatment for latent tuberculosis (TB infection in adults is a daily dose of isoniazid (INH 300 mg for six months. In Brazil, INH was formulated as 100 mg tablets. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested a new 300 mg INH formulation. The aim of our study was to compare the bioavailability of the new INH 300 mg formulation and three 100 mg tablets of the reference formulation. We conducted a randomised, single dose, open label, two-phase crossover bioequivalence study in 28 healthy human volunteers. The 90% confidence interval for the INH maximum concentration of drug observed in plasma and area under the plasma concentration vs. time curve from time zero to the last measurable concentration “time t” was 89.61-115.92 and 94.82-119.44, respectively. The main limitation of our study was that neither adherence nor the safety profile of multiple doses was evaluated. To determine the level of INH in human plasma, we developed and validated a sensitive, simple and rapid high-performance liquid chromatography-tandem mass spectrometry method. Our results showed that the new formulation was bioequivalent to the 100 mg reference product. This finding supports the use of a single 300 mg tablet daily strategy to treat latent TB. This new formulation may increase patients’ adherence to the treatment and quality of life.

  6. Developing an Active Play Resource for a Range of Australian Early Childhood Settings: Formative Findings and Recommendations

    Science.gov (United States)

    Riethmuller, Annaleise; McKeen, Kim; Okely, Anthony D.; Bell, Colin; de Silva Sanigorski, Andrea

    2009-01-01

    Physical activity habits are established in early childhood. Increasing a child's fundamental movement skill confidence and competence may result in a trajectory of increased physical activity and a lower risk of becoming overweight. The evidence upon which the promotion of physical activity in early childhood settings is based is tenuous. This…

  7. "Left to my own devices, I don't know": using theory and patient-reported barriers to move from physical activity recommendations to practice.

    Science.gov (United States)

    Ziebart, C; McArthur, C; Lee, L; Papaioannou, A; Laprade, J; Cheung, A M; Jain, R; Giangregorio, L

    2018-05-01

    Knowledge exchange with community-dwelling individuals across Ontario revealed barriers to implementation of physical activity recommendations that reflected capability, opportunity, and motivation; barriers unique to individuals with osteoporosis include fear of fracturing, trust in providers, and knowledge of exercise terminology. Using the Behaviour Change Wheel, we identified interventions (training, education, modeling) and policy categories (communication/marketing, guidelines, service provision). Physical activity recommendations exist for individuals with osteoporosis; however, to change behavior, we must address barriers and facilitators to their implementation. The purposes of this project are (1) to identify barriers to and facilitators of uptake of disease-specific physical activity recommendations (2) to use the findings to identify behavior change strategies using the Behaviour Change Wheel (BCW). Focus groups and semi-structured interviews were conducted with community-dwelling individuals attending osteoporosis-related programs or education sessions in Ontario. They were stratified by geographic area, urban/rural, and gender, and transcribed verbatim. Two researchers coded data and identified emerging themes. Using the Behaviour Change Wheel framework, themes were categorized into capability, opportunity, and motivation, and interventions were identified. Two hundred forty community-dwelling individuals across Ontario participated (mean ± SD age = 72 ± 8.28). Barriers were as follows: capability: disease-related symptoms hinder exercise and physical activity participation, lack of exercise-related knowledge, low exercise self-efficacy; opportunity: access to exercise programs that meet needs and preferences, limited resources and time, physical activity norms and preferences; motivation: incentives to exercise, fear of fracturing, trust in exercise providers. Interventions selected were training, education, and modeling. Policy categories

  8. Importance of characteristics and modalities of physical activity and exercise in defining the benefits to cardiovascular health within the general population: recommendations from the EACPR (Part I).

    Science.gov (United States)

    Vanhees, L; De Sutter, J; GeladaS, N; Doyle, F; Prescott, E; Cornelissen, V; Kouidi, E; Dugmore, D; Vanuzzo, D; Börjesson, M; Doherty, P

    2012-08-01

    Over the last decades, more and more evidence is accumulated that physical activity (PA) and exercise interventions are essential components in primary and secondary prevention for cardiovascular disease. However, it is less clear whether and which type of PA and exercise intervention (aerobic exercise, dynamic resistive exercise, or both) or characteristic of exercise (frequency, intensity, time or duration, and volume) would yield more benefit in achieving cardiovascular health. The present paper, as the first of a series of three, will make specific recommendations on the importance of these characteristics for cardiovascular health in the population at large. The guidance offered in this series of papers is aimed at medical doctors, health practitioners, kinesiologists, physiotherapists and exercise physiologists, politicians, public health policy makers, and the individual member of the public. Based on previous and the current literature, recommendations from the European Association on Cardiovascular Prevention and Rehabilitation are formulated regarding type, volume, and intensity of PA and exercise.

  9. Quantitative analysis of valsartan by two-dimensional liquid chromatography (2D-HPLC) and its application in a bioequivalence study in Chinese volunteers
.

    Science.gov (United States)

    Zhang, Min; Deng, Yang; Cai, Hua-Lin; Fang, Ping-Fei; Yan, Miao; Zhang, Bi-Kui; Wu, Yan-Qin

    2017-04-01

    To develop a sensitive, two-dimensional liquid chromatography (2D-LC) method for determination of valsartan, applied to investigate bioequivalence of two valsartan tablets in Chinese volunteers under fasting condition. A full automatic 2D-HPLC system was used to quantify valsartan in human plasma. The analytes were extracted by protein precipitation, using telmisartan as internal standard. The analytical method was applied in a randomized, crossover bioequivalence study of valsartan tablets; the study enrolled 18 Chinese volunteers (12 were men and 6 were women). The subjects received a single 160-mg dose of test or reference preparation with 7-days of washout under fasting state. Plasma samples were collected, pharmacokinetic parameters were obtained and the bioequivalence was evaluated. The calibration range was 9.2 - 4213.8 ng×mL-1. Inter- and intraprecision was less than 7.0%, and accuracies ranged from 99.5 to 103.8%. The extraction recovery for valsartan varied between 89.3 and 97.8%, and the stability in all conditions was excellent. The 90% CI of AUC0→36h and Cmax were 96.5 - 109.4% and 94.2 - 108.6%, respectively. The relative bioavailability was 103.9 ± 15.7%. No gender difference was observed in pharmacokinetic parameters. A sensitive 2D-HPLC method was established for the estimation of valsartan in human plasma and successfully applied in a bioequivalence study of valsartan, which suggests that these two formulations can be assumed to be bioequivalent.
.

  10. Effect of Truncating AUC at 12, 24 and 48 hr When Evaluating the Bioequivalence of Drugs with a Long Half-Life.

    Science.gov (United States)

    Moreno, Isabel; Ochoa, Dolores; Román, Manuel; Cabaleiro, Teresa; Abad-Santos, Francisco

    2016-01-01

    Bioequivalence studies of drugs with a long half-life require long periods of time for pharmacokinetic sampling. The latest update of the European guideline allows the area under the curve (AUC) truncated at 72 hr to be used as an alternative to AUC0-t as the primary parameter. The objective of this study was to evaluate the effect of truncating the AUC at 48, 24 and 12 hr on the acceptance of the bioequivalence criterion as compared with truncation at 72 hr in bioequivalence trials. The effect of truncated AUC on the within-individual coefficient of variation (CVw) and on the ratio of the formulations was also analysed. Twenty-eight drugs were selected from bioequivalence trials. Pharmacokinetic data were analysed using WinNonLin 2.0 based on the trapezoidal method. Analysis of variance (ANOVA) was performed to obtain the ratios and 90% confidence intervals for AUC at different time-points. The degree of agreement of AUC0-72 in relation to AUC0-48 and AUC0-24, according to the Landis and Koch classification, was 'almost perfect'. Statistically significant differences were observed when the CVw of AUC truncated at 72, 48 and 24 hr was compared with the CVw of AUC0-12. There were no statistically significant differences in the AUC ratio at any time-point. Compared to AUC0-72, Pearson's correlation coefficient for mean AUC, AUC ratio and AUC CVw was worse for AUC0-12 than AUC0-24 or AUC0-48. These preliminary results could suggest that AUC truncation at 24 or 48 hr is adequate to determine whether two formulations are bioequivalent. © 2015 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  11. Recommendations for simulations to predict environmental concentrations of active substances of plant protection products and their metabolites in groundwater (PECgw) in the national assessment for authorisation in Germany

    Energy Technology Data Exchange (ETDEWEB)

    Holdt, Gabriele; Gallien, Peter; Nehls, Angelika [Umweltbundesamt Dessau (DE)] (and others)

    2011-09-15

    In the national assessment for authorisation in Germany the leaching behaviour of a plant protection product is determined in a stepwise procedure in accordance with FOCUS groundwater report (2009). The recommendations given in this paper here are related to tier 1 and tier 2, only. A further publication is planned for the tier 3 and tier 4 assessments in accordance with the principles provided by FOCUS. The tier 1 leaching assessment in the EU evaluation process is based on the nine FOCUS (2009) standard groundwater scenarios. In the member state evaluation for Germany, a sub-set of the standard scenarios with climatic and soil conditions found to be relevant for Ger-many are taken into account (Hamburg and Kremsmuenster). The soils of the two scenarios cover the pH-range of agricultural soils and allow the pH-dependent behaviour of compounds to be addressed. For the parameterisation of the degradation behaviour of an active substance and its metabolites in soil the recommendations of FOCUS should be followed. Normalised degradation rates may be taken from either laboratory or from field dissipation studies. For the parameterisation of the sorption behaviour of an active substance and its metabolites in soil the recommendations of FOCUS should be considered. With respect to the correlation of degradation and/or sorption behaviour to soil properties (pH, OC) further detailed recommendations are provided to facilitate the selection of conservative sorption parameters for leaching assessment. Proposals and detailed schemes for the handling of the DT50 and Kfoc values (including their variability) are given. Further recommendations are given in this paper on how to use other modelling parameters e.g. crop rotation, plant uptake factor, formation of metabolites, correlations / multi-correlations of substance parameters to soil properties, and application of statistical methods. Tier 2 of the leaching assessment consists of more refined modelling approaches. This

  12. Pharmacological screening of plants recommended by folk medicine as anti-snake venom: I. Analgesic and anti-inflammatory activities

    Directory of Open Access Journals (Sweden)

    Bettina M. Ruppelt

    1991-01-01

    Full Text Available We have observed that several plants used popularly as anti-snake venom show anti-inflammatory activity. From the list prepared by Rizzini, Mors and Pereira some species have been selected and tested for analgesic activity (number of contortions and anti-inflammatory activity (Evans blue dye diffusion - 1% solution according to Whittle's technique (intraperitoneal administration of 0.1 N-acetic acid 0.1 ml/10 g in mice. Previous oral administration of a 10% infusion (dry plant or 20% (fresh plant corresponding to 1 or 2 g/Kg of Apuleia leiocarpa, Casearia sylvestris, Brunfelsia uniflora, Chiococca brachiata, Cynara scolymus, Dorstenia brasiliensis, Elephantopus scaber, Marsypianthes chamaedrys, Mikania glomerata and Trianosperma tayuya demonstrated analgesic and/or anti-inflammatory activities of varied intensity

  13. A randomized controlled trial to evaluate utilization of physical activity recommendations among patients of cardiovascular healthcare centres in Eastern Slovakia: study design and rationale of the AWATAR study.

    Science.gov (United States)

    Zelko, Aurel; Bukova, Alena; Kolarcik, Peter; Bakalar, Peter; Majercak, Ivan; Potocnikova, Jana; Reijneveld, Sijmen A; van Dijk, Jitse P

    2018-04-04

    Guidelines on modifiable risk factors regarding cardiological patients are poorly implemented in clinical practice perhaps due to low health literacy. Several digital tools for improving lifestyle and behavioural intervention were developed. Our primary aim is to evaluate the effectiveness of a digital exercise prescription tool on the adherence to physical activity recommendations among patients with cardiovascular diseases. A randomized controlled trial will be realized in cooperation with Cardiovascular Health Centres in Eastern Slovakia. Patients recruited through their cardiologists, will be randomised at 1:1 ratio to the three-months' experimental condition or control condition. The experimental group will receive standard lifestyle consultation leading to individually optimized prescription of physical activity. The control group will receive standard, usual-cardio-care lifestyle counselling, also in the domain of physical activity. The digital system will be used for optimized exercise prescription. The primary outcome is a change in the patient's adherence to exercise recommendations. Data will be collected in both groups prior to consultation and after 3 months. This study protocol presents background and design of a randomized control trial to investigate the effectiveness of a digital system-provide exercise prescription tool on the adherence to physical activity recommendations. An optimized exercise prescription that better reflects patient's diagnosis, comorbidities and medication can have a significant impact on secondary prevention of cardiovascular disease. This trial can provide important evidence about the effectiveness of digital exercise guidance in everyday practice of cardiovascular healthcare. The study was registered on 1st November, 2017 and is available online at ClinicalTrials.gov (ID: NCT03329053 ).

  14. Compliance with different physical activity recommendations and its association with socio-demographic characteristics using an objective measure.

    Science.gov (United States)

    Scheers, Tineke; Philippaerts, Renaat; Lefevre, Johan

    2013-02-14

    In the past decades, several public health guidelines concerning physical activity have been published. This study evaluated compliance with various physical activity guidelines and examined the associations between meeting the guidelines and socio-demographic characteristics. Data were obtained from 357 Flemish men and women (41.9 ± 9.6 years). Physical activity was assessed for seven consecutive days using the SenseWear Armband. The prevalence of sufficient physical activity was calculated according to various public health guidelines. Logistic regressions examined the associations between socio-demographic characteristics and the odds of meeting the different guidelines. 87.2% of men and 68.1% of women achieved ≥150 min/week of moderate-to-vigorous physical activity (MVPA), but only 57.6% and 37.3% accumulated this amount as ≥30 min/day on ≥5 days/week. With regard to vigorous physical activity, 27.9% of men and 15.7% of women achieved ≥75 min/week and 12.8% and 7.0% achieved ≥20 min/day on ≥3 days/week. In addition, 34.9% of men and 21.6% of women attained an average physical activity level (PAL) of 1.75 MET and thus met the criteria for weight maintenance. Only 16.3% of men and 14.1% of women took 10000 steps/day on 7 days/week. Women had a lower probability of achieving 30 min/day MVPA on 5 days/week (OR: 0.40), or a weekly total of 150 min or 500 MET.min MVPA or 75 min of vigorous activity compared to men (OR: 0.27-0.46). In addition, they were 50% less likely to meet the guidelines for weight maintenance. The odds of engaging in 150 min/week MVPA or attaining a PAL of 1.75 was lower with higher age. Educational level was positively related with accumulating 75 min/week of vigorous activity, but negatively with taking 10000 steps/day. Smokers were 60% less likely to participate weekly in 150 min of MVPA compared to non-smokers. The prevalence of sufficient physical activity differed greatly depending on the definition used. Women and subjects

  15. The advantages of combination therapy on hypertension: development of immediate release perindopril-indapamide tablet and assessment of bioequivalence studies.

    Science.gov (United States)

    Ölçer, A; Ölçer, M; İnce, I; Karasulu, E

    2016-03-01

    Hypertension has a major associated risk for organ damage and mortality, which is further heightened in patients with prior cardiovascular events, comorbid diabetes mellitus, microalbuminuria and renal impairment. Convers Plus tablet including perindopril erbumine (PE), which is an angiotensin converting enzyme (ACE) inhibitor, and indapamide, which is diuretic, was designed as a combined tablet to succes in the treatment of hypertension. Physico-pharmaceutical properties and characterization studies were evaluated in vitro conditions. Later on in vivo study was planned as a cross-designed, randomized, open-labeled, single-dose, single-center study via peroral route in 24 healthy male subjects. In this study, bioequivalence with primary pharmacokinetical target parameters reference (Bipreterax 4/1.25 mg Tablet-S.A.Servier Benelux N.V.) and test (Convers Plus 4/1.25 mg Tablet-ARGESAN Pharmaceutical Company) tablets have been found bioequivalent. The results of pharmacokinetic parameters for perindopril, perindoprilat and indapamide were found as Cmax = 23.179 µg/mL, tmax = 0.729 h, t1/2 = 1.429 h; AUC0-t = 26.998 µgs/mL, AUC0-inf = 27.117 µgs/mL; Cmax = 1.834 µg/mL, tmax = 8.792 h, t1/2 = 40.699 h; AUC0-t = 54.828 µgs/mL, AUC0-inf = 77.113 µgs/mL; Cmax = 18.994 µg/mL, tmax = 3.417 h, t1/2 = 16.626 h and AUC0-t = 385.829 µgs/mL, AUC0-inf = 410.728 µgs/mL respectively. In conclusion, physico-pharmaceutical properties and results of clinical trials show that Convers Plus tablets have been found as bioequivalent for perindopril, perindoprilat and indapamide in terms of AUC and Cmax, in 90% confidence limits.

  16. Bioequivalence of diclofenac sodium 2% and 1.5% topical solutions relative to oral diclofenac sodium in healthy volunteers.

    Science.gov (United States)

    Holt, Robert J; Taiwo, Tolu; Kent, Jeffrey D

    2015-08-01

    Topical formulations of nonsteroidal anti-inflammatory drugs (NSAIDs) are generally considered to be safer alternatives to oral NSAIDs due to lower systemic absorption. We conducted randomized, crossover studies that compared the pharmacokinetics (PK), bioequivalence and safety of topical diclofenac sodium 2% twice daily (BID), diclofenac sodium 1.5% four times daily (QID) and oral diclofenac sodium in healthy subjects. The results of three bioequivalence studies are reviewed. Healthy adult subjects (n = 76) applied topical diclofenac sodium 2% solution (40.4 mg/2 mL) BID; or 1.5% solution (19.3 mg/40 drops) QID to each knee for 7.5 consecutive days separated by a washout period. Subjects (n = 22) in one study also received oral diclofenac sodium 75 mg BID for 7.5 days. Plasma diclofenac concentrations were determined from serial blood samples collected on Days 1 and 8 (steady state), and diclofenac PK parameters were estimated by noncompartmental methods. The studies demonstrated comparable bioequivalence between the 2% and 1.5% topical solutions as well as lower systemic exposure compared to oral dosing (approximately 93% less). Daily systemic exposure was comparable between the two formulations with only a 12% difference in the AUCss(0-24) (p = 0.140). Furthermore, both topical solutions demonstrated delayed elimination with a t(1/2) of 4- to 6-fold longer, as compared to oral diclofenac. The 2% solution provided more consistent dosing relative to the 1.5% solution when comparing AUCss(0-24) and Cmaxss across studies. Mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac. The steady-state PK profile of topical diclofenac 2% solution administered BID is similar to that of the 1.5% solution administered QID. Systemic exposure to diclofenac is substantially lower after topical application as compared to oral administration. (Study 2 was registered with ClinicalTrials.gov; NCT01202799; https

  17. Trends in Adults Receiving a Recommendation for Exercise or Other Physical Activity from a Physician or Other Health ...

    Science.gov (United States)

    ... U.S. national physical activity plan. J Phys Act Health 6(suppl 2):S211–9. 2009. Weidinger KA, Lovegreen SL, Elliott MB, Hagood L, Haire-Joshu D, Mcgill JB, Brownson RC. How to make exercise counseling more effective: Lessons from rural America. J Fam Pract 57( ...

  18. Special report: workshop on 4D-treatment planning in actively scanned particle therapy--recommendations, technical challenges, and future research directions.

    Science.gov (United States)

    Knopf, Antje; Bert, Christoph; Heath, Emily; Nill, Simeon; Kraus, Kim; Richter, Daniel; Hug, Eugen; Pedroni, Eros; Safai, Sairos; Albertini, Francesca; Zenklusen, Silvan; Boye, Dirk; Söhn, Matthias; Soukup, Martin; Sobotta, Benjamin; Lomax, Antony

    2010-09-01

    This article reports on a 4D-treatment planning workshop (4DTPW), held on 7-8 December 2009 at the Paul Scherrer Institut (PSI) in Villigen, Switzerland. The participants were all members of institutions actively involved in particle therapy delivery and research. The purpose of the 4DTPW was to discuss current approaches, challenges, and future research directions in 4D-treatment planning in the context of actively scanned particle radiotherapy. Key aspects were addressed in plenary sessions, in which leaders of the field summarized the state-of-the-art. Each plenary session was followed by an extensive discussion. As a result, this article presents a summary of recommendations for the treatment of mobile targets (intrafractional changes) with actively scanned particles and a list of requirements to elaborate and apply these guidelines clinically.

  19. Collective knowledge: Using a Consensus Conference approach to develop recommendations for physical activity and nutrition programs for persons with Type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Tanya eBerry

    2012-12-01

    Full Text Available The purpose of this consensus conference was to have a lay panel of persons with type 2 diabetes (T2D work in collaboration with an expert panel of diabetes professionals to develop strategies designed to improve dietary and physical activity adherence in persons with T2D. Lay panel participants were 15 people living with T2D. The seven experts had expertise in exercise management, cardiovascular risk factors, community-based lifestyle interventions, healthy weight strategies, the glycemic index, exercise motivation, and social, environmental and cultural interactions. All meetings were facilitated by a professional, neutral facilitator. During the conference each expert gave a 15-minute presentation answering questions developed by the lay panel and all panel members worked to generate suggestions for programs and ways in which the needs of persons with T2D may be better met. A subgroup of the lay panel used the suggestions created from the conference to generate a final list of recommendations. Recommendations were categorized into 1 diagnosis/awareness (e.g., increasing awareness about T2D in the general public, need for lifelong self-monitoring post-diagnosis; 2 education for the person with diabetes (e.g., periodic refresher courses, professionals (e.g., regular interactions between researchers and persons with T2D so researchers better understand the needs of the affected population, and the community (e.g., support for families and employers; and 3 ongoing support (e.g., peer support groups. The recommendations from the conference can be used by researchers to design and evaluate physical activity and nutrition programs. The results can also be of use to policy makers and health promoters interested in increasing adherence to physical activity and nutrition guidelines among persons with T2D.

  20. Does a mere request to recommend have an impact on the customer’s word-of-mouth activity?

    DEFF Research Database (Denmark)

    Mattsson, Jan; Söderlund, Magnus

    Both researchers and practitioners believe that word-of-mouth (WOM) is producing beneficial effects for the firm, and therefore it is no surprise that copious studies have examined factors assumed to boost the customer’s WOM activity. Many such factors have been identified, particularly global...... encounters) to provide WOM would have a positive impact on WOM activity. We base this assumption on the question-behavior effect identified with regard to questions in questionnaires, on reciprocity theory, and on arguments related to customer benefits that may be evoked by a request for WOM. This purpose....... In addition, we found that receiving WOM requests was not negatively associated with overall evaluations, such as customer satisfaction, which indicates that the potential for negative effects of making the request seems to be low....

  1. Recommendations for a culturally relevant Internet-based tool to promote physical activity among overweight young African American women, Alabama, 2010-2011.

    Science.gov (United States)

    Durant, Nefertiti H; Joseph, Rodney P; Cherrington, Andrea; Cuffee, Yendelela; Knight, BernNadette; Lewis, Dwight; Allison, Jeroan J

    2014-01-16

    Innovative approaches are needed to promote physical activity among young adult overweight and obese African American women. We sought to describe key elements that African American women desire in a culturally relevant Internet-based tool to promote physical activity among overweight and obese young adult African American women. A mixed-method approach combining nominal group technique and traditional focus groups was used to elicit recommendations for the development of an Internet-based physical activity promotion tool. Participants, ages 19 to 30 years, were enrolled in a major university. Nominal group technique sessions were conducted to identify themes viewed as key features for inclusion in a culturally relevant Internet-based tool. Confirmatory focus groups were conducted to verify and elicit more in-depth information on the themes. Twenty-nine women participated in nominal group (n = 13) and traditional focus group sessions (n = 16). Features that emerged to be included in a culturally relevant Internet-based physical activity promotion tool were personalized website pages, diverse body images on websites and in videos, motivational stories about physical activity and women similar to themselves in size and body shape, tips on hair care maintenance during physical activity, and online social support through social media (eg, Facebook, Twitter). Incorporating existing social media tools and motivational stories from young adult African American women in Internet-based tools may increase the feasibility, acceptability, and success of Internet-based physical activity programs in this high-risk, understudied population.

  2. Extraterritorial reach of the FCPA: recommendations for U.S. medical device companies with activities in Europe.

    Science.gov (United States)

    Vollebregt, Erik

    2010-01-01

    Traditionally medical devices companies manage business compliance with anti-corruption and anti-fraud rules in a document-oriented way that does not always yield optimal results for the company. As a result, compliance issues are not optimally managed by the companies. Now that medical devices companies become ever more internationally active, they must also take into account the international dimensions of business compliance. This article intends to provide U.S. medical devices companies with activities in Europe with an insight in business compliance risks in the European Union (EU) and the risks related to U.S. statutes that may be applicable to a U.S. company's activities overseas. The article proposes a process-oriented and IT-supported way of structuring an international business compliance program, resulting in increased effectiveness of the program and increased competitiveness and risk management of the company as well as a high degree of acceptance of the procedures by the company's employees.

  3. Knowledge of physical activity recommendations in adults employed in England: associations with individual and workplace-related predictors.

    Science.gov (United States)

    Knox, Emily C L; Musson, Hayley; Adams, Emma J

    2015-05-23

    Physical activity guidelines state that adults should engage in at least 150 min of moderate to vigorous physical activity (MVPA) per week to benefit health. A high proportion of adults in England fail to reach this target. Accurate knowledge of MVPA guidelines could influence the amount and quality of MVPA engaged in by adults. This study aimed to determine knowledge of the MVPA guideline within a large sample of working adults in England and identify individual and workplace-related predictors of knowledge. 10,992 adults completed an online survey which included questions on demographics, knowledge of the MVPA guideline and workplace predictors for physical activity. Multinomial logistic regression identified predictors of underestimating, overestimating or not knowing the MVPA guideline relative to accurately reporting the guideline for males and females separately. Respondents were 37% male, 95% White, 63% with a degree or higher, and had a mean age of 38.9 ± 11 years. The MVPA guideline was accurately reported by 15% of adults while 13.8% overestimated, 8.9% underestimated and 62.3% failed to provide any estimate of the guideline. Low education predicted underestimation (females: OR = 0.36, 95% CI 0.17, 0.80) and not knowing (males: OR = 0.37, 95% CI 0.14, 0.96; females: OR = 0.36, 95% CI 0.19, 0.69). Ethnicity was a significant predictor for females only (OR 3.55, 95% CI 1.46, 8.63; OR 4.03, 95% CI 1.58, 10.27; OR 3.73, 95% CI 1.67, 8.33). Employer support for physical activity was a significant predictor of accurate knowledge of the MVPA guideline for both males (underestimation: OR = 0.63, 95% CI 0.40, 1.00; 'don't know': OR = 0.71, 95% CI 0.51, 1.00) and females (overestimation: OR = 0.72, 95% CI 0.53, 0.97; underestimation: OR = 0.66, 95% CI 0.47, 0.92; 'don't know': OR = 0.60, 95% CI 0.47, 0.76). Knowledge of the MVPA guideline within working adults in England is low. Employers should play a role in using targeted

  4. Different truncation methods of AUC between Japan and the EU for bioequivalence assessment: influence on the regulatory judgment.

    Science.gov (United States)

    Oishi, Masayo; Chiba, Koji; Fukushima, Takashi; Tomono, Yoshiro; Suwa, Toshio

    2012-01-01

    In regulatory guidelines for bioequivalence (BE) assessment, the definitions of AUC for primary assessment are different in ICH countries, i.e., AUC from zero to the last sampling point (AUCall) in Japan, AUC from zero to infinity (AUCinf) or AUC from zero to the last measurable point (AUClast) in the US, and AUClast in the EU. To assure sufficient accuracy of truncated AUC for BE assessment, the ratio of truncated AUC (AUCall or AUClast) to AUCinf should be more than 80% both in Japanese and EU guidelines. We investigated how the difference in the definition of truncated AUC affects BE assessment of sustained release (SR) formulation. Our simulation result demonstrated that AUCall/AUCinf could be ≥80% despite AUClast/AUCinf being AUC affected the judgment of validity of truncated AUC for BE assessment, and AUCall could fail to detect the substantially different in vivo dissolution profile of generic drugs with SR formulation from the original drug.

  5. Semi-physiologic model validation and bioequivalence trials simulation to select the best analyte for acetylsalicylic acid.

    Science.gov (United States)

    Cuesta-Gragera, Ana; Navarro-Fontestad, Carmen; Mangas-Sanjuan, Victor; González-Álvarez, Isabel; García-Arieta, Alfredo; Trocóniz, Iñaki F; Casabó, Vicente G; Bermejo, Marival

    2015-07-10

    The objective of this paper is to apply a previously developed semi-physiologic pharmacokinetic model implemented in NONMEM to simulate bioequivalence trials (BE) of acetyl salicylic acid (ASA) in order to validate the model performance against ASA human experimental data. ASA is a drug with first-pass hepatic and intestinal metabolism following Michaelis-Menten kinetics that leads to the formation of two main metabolites in two generations (first and second generation metabolites). The first aim was to adapt the semi-physiological model for ASA in NOMMEN using ASA pharmacokinetic parameters from literature, showing its sequential metabolism. The second aim was to validate this model by comparing the results obtained in NONMEM simulations with published experimental data at a dose of 1000 mg. The validated model was used to simulate bioequivalence trials at 3 dose schemes (100, 1000 and 3000 mg) and with 6 test formulations with decreasing in vivo dissolution rate constants versus the reference formulation (kD 8-0.25 h (-1)). Finally, the third aim was to determine which analyte (parent drug, first generation or second generation metabolite) was more sensitive to changes in formulation performance. The validation results showed that the concentration-time curves obtained with the simulations reproduced closely the published experimental data, confirming model performance. The parent drug (ASA) was the analyte that showed to be more sensitive to the decrease in pharmaceutical quality, with the highest decrease in Cmax and AUC ratio between test and reference formulations. Copyright © 2015 Elsevier B.V. All rights reserved.

  6. Pharmacokinetics and bioequivalence study of a fixed dose combination of rabeprazole and itopride in healthy Indian volunteers.

    Science.gov (United States)

    Sahoo, Bijay Kumar; Das, Ayan; Agarwal, Sangita; Bhaumik, Uttam; Bose, Anirbandeep; Ghosh, Debotri; Roy, Bikash; Pal, Tapan Kumar

    2009-01-01

    The aim of the present study was to compare the pharmacokinetics of rabeprazole (CAS 117976-89-3) and itopride (CAS 122898-67-3) after oral administration of a rabeprazole (20 mg)-itopride (150 mg) fixed dose combination (FDC) in healthy human volunteers. The bioequivalence of two formulations (test and reference) was determined in 12 healthy Indian male volunteers (age: 25.25 +/- 4.69 years; weight: 60.50 +/- 5.04 kg) in a randomized, single-dose, two-period, two-treatment crossover study. Both formulations were administered orally as a single dose, with the treatments separated by a washout period of 1 week. Rabeprazole and itopride plasma levels were determined by a validated HPLC method using UV detection. The formulations were compared using the pharmacokinetic parameters area under the plasma concentration-time curve (AUC(0-t)), area under the plasma concentration-time curve from zero to infinity (AUC(0-infinity)) and peak plasma concentration (Cmax). General linear model (GLM) procedures were used in which sources of variation were subject, treatment and period. The results indicated that there were no statistically significant differences (P > 0.05) between the logarithmically transformed AUC(0-infinity) and Cmax values between test and reference formulation. The 90% confidence interval for the ratio of the logarithmically transformed AUC(0-t), AUC(0-infinity) and Cmax were within the bioequivalence limits of 0.8-1.25 and the relative bioavailability of rabeprazole and itopride test and reference formulations was 98.24 and 93.65%, respectively.

  7. Should physical activity recommendations be ethnicity-specific? Evidence from a cross-sectional study of South Asian and European men.

    Directory of Open Access Journals (Sweden)

    Carlos A Celis-Morales

    Full Text Available Expert bodies and health organisations recommend that adults undertake at least 150 min.week(-1 of moderate-intensity physical activity (MPA. However, the underpinning data largely emanate from studies of populations of European descent. It is unclear whether this level of activity is appropriate for other ethnic groups, particularly South Asians, who have increased cardio-metabolic disease risk compared to Europeans. The aim of this study was to explore the level of MPA required in South Asians to confer a similar cardio-metabolic risk profile to that observed in Europeans undertaking the currently recommended MPA level of 150 min.week(-1.Seventy-five South Asian and 83 European men, aged 40-70, without cardiovascular disease or diabetes had fasted blood taken, blood pressure measured, physical activity assessed objectively (using accelerometry, and anthropometric measures made. Factor analysis was used to summarise measured risk biomarkers into underlying latent 'factors' for glycaemia, insulin resistance, lipid metabolism, blood pressure, and overall cardio-metabolic risk. Age-adjusted regression models were used to determine the equivalent level of MPA (in bouts of ≥ 10 minutes in South Asians needed to elicit the same value in each factor as Europeans undertaking 150 min.week(-1 MPA.For all factors, except blood pressure, equivalent MPA values in South Asians were significantly higher than 150 min.week(-1; the equivalent MPA value for the overall cardio-metabolic risk factor was 266 (95% CI 185-347 min.week(-1.South Asian men may need to undertake greater levels of MPA than Europeans to exhibit a similar cardio-metabolic risk profile, suggesting that a conceptual case can be made for ethnicity-specific physical activity guidance. Further study is needed to extend these findings to women and to replicate them prospectively in a larger cohort.

  8. Non-exercise Estimation of V02max Using a Dichotomy of Meeting or Not Meeting DHHS Physical Activity Recommendations

    Science.gov (United States)

    Wier, Larry T.; Jackson, Allen W.; Jackson, Andrew S.

    2009-01-01

    The physical activity guidelines (PAG) established by the US Dept. of Health and Human Services in 2008 is consistent with a rating of >/= 6 on the 11-point NASA Physical Activity Status Scale (PASS). Wier, et. al. developed non-exercise models for estimating VO2(sub max) from a combination of PASS, age, gender and either waist girth (WG) (R = 0.810, SEE= 4.799 ml/kg/min), %Fat (R = 0. 817, SEE = 4.716 ml/kg/min) or BMI (R = 0.802, SEE = 4.900 ml . kg-1. min -1 ). PURPOSE: to develop non-exercise models to estimate VO2max from age, gender, body composition (WG, %Fat, BMI) and PASS dichotomized at meets or does not meet the PAG (PAG-PASS), and to compare the accuracy of the PAG-PASS models with the models using the 11-point PASS. METHODS: 2417 men and 384 women were measured for VO2max by indirect calorimetry (RER >1.1); age (yr), gender by M = 1, W = 0; WG at the umbilicus; %fat by skin-folds, BMI by weight (kg) divided by height squared (m 2 ) , and PAGPASS by PASS 6 = 1. RESULTS: Three models were developed by multiple regression to estimate VO2(sub max) from age, gender, PAG-PASS and either WG (R = 0.790, SEE=5.019 ml/kg/min), %FAT (R= 0.080, SEE = 4.915 ml/kg/min) or BMI (R = 0.777, SEE = 5.162ml/kg/min). Cross-validation by the PRESS technique confirmed these statistics. Simple correlations between measured VO2(sub max) and estimates from the PAG-PASS models with WG, %Fat and BMI were 0.790, 0.800 and 0.777, minimally different from the correlations obtained with the PASS models (0.810, 0.810, and 0.802). PAG-PASS and PASS model constant errors were also similar: gender, PASS and for VO2(sub max) between 30 and 50 ml/kg/min (70% of the sample) but > 1 ml/kg/min for VO2(sub max) 50 ml/kg/min. CONCLUSIONS: Non-exercise models using the combined effects of age, gender, body composition and the dichotomized PAG-PASS provide estimates of VO2(sub max) that are accurate for most adults, and the accuracy of these models are similar to previously published models using

  9. Non-exercise Estimation of V02max Using a Dichotomy of Meeting or Not Meeting DHHS Physical Activity Recommendations

    Science.gov (United States)

    Wier, Larry T.; Jackson, Allen W.; Jackson, Andrew S.

    2009-01-01

    The physical activity guidelines (PAG) established by the US Dept. of Health and Human Services in 2008 is consistent with a rating of >/= 6 on the 11-point NASA Physical Activity Status Scale (PASS). Wier, et. al. developed non-exercise models for estimating VO2(sub max) from a combination of PASS, age, gender and either waist girth (WG) (R = 0.810, SEE= 4.799 ml/kg/min), %Fat (R = 0. 817, SEE = 4.716 ml/kg/min) or BMI (R = 0.802, SEE = 4.900 ml . kg-1. min -1 ). PURPOSE: to develop non-exercise models to estimate VO2max from age, gender, body composition (WG, %Fat, BMI) and PASS dichotomized at meets or does not meet the PAG (PAG-PASS), and to compare the accuracy of the PAG-PASS models with the models using the 11-point PASS. METHODS: 2417 men and 384 women were measured for VO2max by indirect calorimetry (RER >1.1); age (yr), gender by M = 1, W = 0; WG at the umbilicus; %fat by skin-folds, BMI by weight (kg) divided by height squared (m 2 ) , and PAGPASS by PASS 6 = 1. RESULTS: Three models were developed by multiple regression to estimate VO2(sub max) from age, gender, PAG-PASS and either WG (R = 0.790, SEE=5.019 ml/kg/min), %FAT (R= 0.080, SEE = 4.915 ml/kg/min) or BMI (R = 0.777, SEE = 5.162ml/kg/min). Cross-validation by the PRESS technique confirmed these statistics. Simple correlations between measured VO2(sub max) and estimates from the PAG-PASS models with WG, %Fat and BMI were 0.790, 0.800 and 0.777, minimally different from the correlations obtained with the PASS models (0.810, 0.810, and 0.802). PAG-PASS and PASS model constant errors were also similar: 1 ml/kg/min for VO2(sub max) 50 ml/kg/min. CONCLUSIONS: Non-exercise models using the combined effects of age, gender, body composition and the dichotomized PAG-PASS provide estimates of VO2(sub max) that are accurate for most adults, and the accuracy of these models are similar to previously published models using the 11-point PASS.

  10. Factoring in weather variation to capture the influence of urban design and built environment on globally recommended levels of moderate to vigorous physical activity in children.

    Science.gov (United States)

    Katapally, Tarun Reddy; Rainham, Daniel; Muhajarine, Nazeem

    2015-11-30

    In curbing physical inactivity, as behavioural interventions directed at individuals have not produced a population-level change, an ecological perspective called active living research has gained prominence. However, active living research consistently underexplores the role played by a perennial phenomenon encompassing all other environmental exposures-variation in weather. After factoring in weather variation, this study investigated the influence of diverse environmental exposures (including urban design and built environment) on the accumulation of globally recommended moderate to vigorous physical activity levels (MVPA) in children. This cross-sectional observational study is part of an active living initiative set in the Canadian prairie city of Saskatoon. As part of this study, Saskatoon's neighbourhoods were classified based on urban street design into grid-pattern, fractured grid-pattern and curvilinear types of neighbourhoods. Moreover, diverse environmental exposures were measured including, neighbourhood built environment, and neighbourhood and household socioeconomic environment. Actical accelerometers were deployed between April and June 2010 (spring-summer) to derive MVPA of 331 10-14-year-old children in 25 1-week cycles. Each cycle of accelerometry was conducted on a different cohort of children within the total sample and matched with weather data obtained from Environment Canada. Multilevel modelling using Hierarchical Linear and Non-linear Modelling software was conducted by factoring in weather variation to depict the influence of diverse environmental exposures on the accumulation of recommended MVPA. Urban design, including diversity of destinations within neighbourhoods played a significant role in the accumulation of MVPA. After factoring in weather variation, it was observed that children living in neighbourhoods closer to the city centre (with higher diversity of destinations) were more likely to accumulate recommended MVPA. The findings

  11. Bioequivalence of a single 400-mg dose of imatinib 100-mg oral tablets and a 400-mg tablet in healthy adult Korean volunteers.

    Science.gov (United States)

    Lee, Hae Won; Seong, Sook Jin; Park, Sung Min; Lee, Joomi; Gwon, Mi-Ri; Kim, Hyun-Ju; Lim, Sung Mook; Lim, Mi-Sun; Kim, Woomi; Yang, Dong Heon; Yoon, Young-Ran

    2015-06-01

    Imatinib mesylate (IM) is a selective tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors. A new once-daily 400-mg film-coated tablet of imatinib has been developed by a pharmaceutical company in Korea. The present study was designed to assess and compare the PK parameters, bioavailability, and bioequivalence of the new imatinib 400-mg formulation (test) versus the conventional 100-mg formulation (reference) administered as a single 400-mg dose in healthy adult male volunteers. This randomized, open-label, single-dose, two-way crossover study was conducted in healthy Korean male volunteers. Eligible subjects were randomly assigned in a 1 : 1 ratio to receive 400 mg of the test (one 400-mg tablet) or reference (four 100-mg tablets) formulation, followed by a 2-week washout period and administration of the alternate formulation. Serial blood samples were collected at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours after administration. Plasma imatinib concentrations were determined using liquid chromatography coupled with tandem mass spectrometry. The formulations were to be considered bioequivalent if the 90% confidence intervals (CIs) of the adjusted geometric mean ratios for Cmax, AUC(0-t), and AUC(0-∞)ž were within the predetermined range of 0.80 - 1.25. In total, 35 subjects completed the study. No serious adverse event was reported during the study. The 90% CIs of the adjusted geometric mean ratios of the test formulation to the reference formulation for C(max), AUC(0-t) and AUC(0-∞)ž of imatinib were all within the bioequivalence criteria range of 0.8 - 1.25. The test formulation of imatinib met the Korean regulatory requirements for bioequivalence. Both imatinib formulations were well-tolerated in all subjects.

  12. Average bioequivalence of single 500 mg doses of two oral formulations of levofloxacin: a randomized, open-label, two-period crossover study in healthy adult Brazilian volunteers

    Directory of Open Access Journals (Sweden)

    Eunice Kazue Kano

    2015-03-01

    Full Text Available Average bioequivalence of two 500 mg levofloxacin formulations available in Brazil, Tavanic(c (Sanofi-Aventis Farmacêutica Ltda, Brazil, reference product and Levaquin(c (Janssen-Cilag Farmacêutica Ltda, Brazil, test product was evaluated by means of a randomized, open-label, 2-way crossover study performed in 26 healthy Brazilian volunteers under fasting conditions. A single dose of 500 mg levofloxacin tablets was orally administered, and blood samples were collected over a period of 48 hours. Levofloxacin plasmatic concentrations were determined using a validated HPLC method. Pharmacokinetic parameters Cmax, Tmax, Kel, T1/2el, AUC0-t and AUC0-inf were calculated using noncompartmental analysis. Bioequivalence was determined by calculating 90% confidence intervals (90% CI for the ratio of Cmax, AUC0-t and AUC0-inf values for test and reference products, using logarithmic transformed data. Tolerability was assessed by monitoring vital signs and laboratory analysis results, by subject interviews and by spontaneous report of adverse events. 90% CIs for Cmax, AUC0-t and AUC0-inf were 92.1% - 108.2%, 90.7% - 98.0%, and 94.8% - 100.0%, respectively. Observed adverse events were nausea and headache. It was concluded that Tavanic(c and Levaquin(c are bioequivalent, since 90% CIs are within the 80% - 125% interval proposed by regulatory agencies.

  13. Change in weight and body composition in obese subjects following a hypocaloric diet plus different training programs or physical activity recommendations.

    Science.gov (United States)

    Benito, Pedro J; Bermejo, Laura M; Peinado, Ana B; López-Plaza, Bricia; Cupeiro, Rocío; Szendrei, Barbara; Calderón, Francisco J; Castro, Eliane A; Gómez-Candela, Carmen

    2015-04-15

    The aim of the present study was to compare the effects of different physical activity programs, in combination with a hypocaloric diet, on anthropometric variables and body composition in obese subjects. Ninety-six obese (men: n = 48; women: n = 48; age range: 18-50 yr) participated in a supervised 22-wk program. They were randomized into four groups: strength training (S; n = 24), endurance training (E; n = 26), combined strength + endurance training (SE; n = 24), and physical activity recommendations (C; n = 22). In addition, all groups followed the same hypocaloric diet. At baseline and at the end of the intervention, dietetic and physical activity variables were assessed using validated questionnaires. Anthropometric variables were recorded along with body composition variables measured using dual-energy X-ray absorptiometry techniques. At the end of the intervention, significant improvements were seen within groups in terms of body weight (S: -9.21 ± 0.83 kg; E: -10.55 ± 0.80 kg; SE: -9.88 ± 0.85 kg; C: -8.69 ± 0.89 kg), and total fat mass (S: -5.24 ± 0.55%; E: -5.35 ± 0.55%; SE: -4.85 ± 0.56%; C: -4.89 ± 0.59%). No differences were seen between groups at this time in terms of any other anthropometric or body composition variables examined. All groups increased their total physical activity in metabolic equivalents (MET) per week during the intervention, but with no difference between groups (S: 976 ± 367 MET-min/wk; E: 954 ± 355 MET-min/wk; SE: 1 329 ± 345 MET-min/wk; C: 763 ± 410 MET-min/wk). This study shows that, when combined with a hypocaloric diet, exercise training and adherence to physical activity recommendations are equally effective at reducing body weight and modifying body composition in the treatment of obesity (Clinical Trials Gov. number: NCT01116856). Copyright © 2015 the American Physiological Society.

  14. An approach to the selection of recommended cooling intervals for the activation analysis of unknown samples with Ge(Li) gamma-ray spectrometry

    International Nuclear Information System (INIS)

    Hirose, Akio; Ishii, Daido

    1975-01-01

    Estimation of the optimum cooling interval by the mathematic or graphic method for Ge(Li) γ-ray spectrometry performed in the presence of some Compton interferences, and the recommended cooling intervals available for activation analysis of unknown samples have been proposed, and applied to the non-destructive activation analysis of gold in pure copper. In the presence of Compton interferences, two kinds of optimum cooling intervals were discussed. One maximizes the S/N ratio of a desired photo-peak. This interval had been originated by Isenhour, et al. Using the computer technique, this work is abbreviated as tsub( s/ n). The other, which minimizes the relative standard deviation (delta s/S) of a net photo-peak counting rate of interest (S) was originated by Tomov, et al. and Quittner, et al., this work is abbreviated as tsub(opt) or t'sub(opt). All equations derived by the above authors, however, have the practical disadvantage of including a term relating to the intensity of the desired photo-peak, thus making it difficult to predict the optimum cooling interval before irradiation. Since in chemical analysis, the concentration of the desired element, or the intensity of the photo-peak of interest, should be considered as ''unknown''. In the present work, an approach to the selection of recommended cooling interval applicable to the unknown sample has been discussed, and the interval, tsub(opt), which minimizes the lower limit of detection of a desired element under given irradiation and counting conditions has been proposed. (Evans, J.)

  15. Learning Design of Problem Based Learning Model Based on Recommendations of Sintax Study and Contents Issues on Physics Impulse Materials with Experimental Activities

    Directory of Open Access Journals (Sweden)

    Kristia Agustina

    2017-08-01

    Full Text Available This study aims to design learning Problem Based Learning Model based on syntax study recommendations and content issues on Physics Impulse materials through experiments. This research is a development research with Kemp model. The reference for making the learning design is the result of the syntax study and the content of existing PBL implementation problems from Agustina research. This instructional design is applied to the physics material about Impulse done through experimental activity. Limited trials were conducted on the SWCU Physics Education Study Program students group Salatiga, while the validity test was conducted by high school teachers and physics education lecturers. The results of the trial evaluation are limited and the validity test is used to improve the designs that have been made. The conclusion of this research is the design of learning by using PBL model on Impuls material by referring the result of syntax study and the problem content of existing PBL implementation can be produced by learning activity designed in laboratory experiment activity. The actual problem for Impuls material can be used car crash test video at factory. The results of validation tests and limited trials conducted by researchers assessed that the design of learning made by researchers can be used with small revisions. Suggestions from this research are in making learning design by using PBL model to get actual problem can by collecting news that come from newspaper, YouTube, internet, and television.

  16. Bioequivalence of two lansoprazole delayed release capsules 30 mg in healthy male volunteers under fasting, fed and fasting-applesauce conditions: a partial replicate crossover study design to estimate the pharmacokinetics of highly variable drugs.

    Science.gov (United States)

    Thota, S; Khan, S M; Tippabhotla, S K; Battula, R; Gadiko, C; Vobalaboina, V

    2013-11-01

    An open-label, 2-treatment, 3-sequence, 3-period, single-dose, partial replicate crossover studies under fasting (n=48), fed (n=60) and fasting-applesauce (n=48) (sprinkled on one table spoonful of applesauce) modalities were conducted in healthy adult male volunteers to evaluate bioequivalence between 2 formulations of lansoprazole delayed release capsules 30 mg. In all the 3 studies, as per randomization, either test or reference formulations were administered in a crossover manner with a required washout period of at least 7 days. Blood samples were collected adequately (0-24 h) to determine lansoprazole plasma concentrations using a validated LC-MS/MS analytical method. To characterize the pharmacokinetic parameters (Cmax, AUC0-t, AUC0-∞, Tmax, Kel and T1/2) of lansoprazole, non-compartmental analysis and ANOVA was applied on ln-transformed values. The bioequivalence was tested based on within-subject variability of the reference formulation. In fasting and fed studies (within-subject variability>30%) bioequivalence was evaluated with scaled average bioequivalence, hence for the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞, the 95% upper confidence bound for (μT-μR)2-θσ2 WR was ≤0, and the point estimates (test-to-reference ratio) were within the regulatory acceptance limit 80.00-125.00%. In fasting-applesauce study (within-subject variability<30%) bioequivalence was evaluated with average bioequivalence, the 90% CI of ln-transformed data of Cmax, AUC0-t and AUC0-∞ were within the regulatory acceptance limit 80.00-125.00%. Based on these aforesaid statistical inferences, it was concluded that the test formulation is bioequivalent to reference formulation. © Georg Thieme Verlag KG Stuttgart · New York.

  17. The biowaiver extension for BCS class III drugs: the effect of dissolution rate on the bioequivalence of BCS class III immediate-release drugs predicted by computer simulation.

    Science.gov (United States)

    Tsume, Yasuhiro; Amidon, Gordon L

    2010-08-02

    The Biopharmaceutical Classification System (BCS) guidance issued by the FDA allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release (IR) solid oral dosage forms only for BCS class I drugs. However, a number of drugs within BCS class III have been proposed to be eligible for biowaivers. The World Health Organization (WHO) has shortened the requisite dissolution time of BCS class III drugs on their Essential Medicine List (EML) from 30 to 15 min for extended biowaivers; however, the impact of the shorter dissolution time on AUC(0-inf) and C(max) is unknown. The objectives of this investigation were to assess the ability of gastrointestinal simulation software to predict the oral absorption of the BCS class I drugs propranolol and metoprolol and the BCS class III drugs cimetidine, atenolol, and amoxicillin, and to perform in silico bioequivalence studies to assess the feasibility of extending biowaivers to BCS class III drugs. The drug absorption from the gastrointestinal tract was predicted using physicochemical and pharmacokinetic properties of test drugs provided by GastroPlus (version 6.0). Virtual trials with a 200 mL dose volume at different drug release rates (T(85%) = 15 to 180 min) were performed to predict the oral absorption (C(max) and AUC(0-inf)) of the above drugs. Both BCS class I drugs satisfied bioequivalence with regard to the release rates up to 120 min. The results with BCS class III drugs demonstrated bioequivalence using the prolonged release rate, T(85%) = 45 or 60 min, indicating that the dissolution standard for bioequivalence is dependent on the intestinal membrane permeability and permeability profile throughout the gastrointestinal tract. The results of GastroPlus simulations indicate that the dissolution rate of BCS class III drugs could be prolonged to the point where dissolution, rather than permeability, would control the overall absorption. For BCS class III drugs with intestinal absorption patterns

  18. Importance of characteristics and modalities of physical activity and exercise in the management of cardiovascular health in individuals with cardiovascular risk factors: recommendations from the EACPR. Part II.

    Science.gov (United States)

    Vanhees, L; Geladas, N; Hansen, D; Kouidi, E; Niebauer, J; Reiner, Z; Cornelissen, V; Adamopoulos, S; Prescott, E; Börjesson, M; Bjarnason-Wehrens, B; Björnstad, H H; Cohen-Solal, A; Conraads, V; Corrado, D; De Sutter, J; Doherty, P; Doyle, F; Dugmore, D; Ellingsen, Ø; Fagard, R; Giada, F; Gielen, S; Hager, A; Halle, M; Heidbüchel, H; Jegier, A; Mazic, S; McGee, H; Mellwig, K P; Mendes, M; Mezzani, A; Pattyn, N; Pelliccia, A; Piepoli, M; Rauch, B; Schmidt-Trucksäss, A; Takken, T; van Buuren, F; Vanuzzo, D

    2012-10-01

    In a previous paper, as the first of a series of three on the importance of characteristics and modalities of physical activity (PA) and exercise in the management of cardiovascular health within the general population, we concluded that, in the population at large, PA and aerobic exercise capacity clearly are inversely associated with increased cardiovascular disease risk and all-cause and cardiovascular mortality and that a dose–response curve on cardiovascular outcome has been demonstrated in most studies. More and more evidence is accumulated that engaging in regular PA and exercise interventions are essential components for reducing the severity of cardiovascular risk factors, such as obesity and abdominal fat, high BP, metabolic risk factors, and systemic inflammation. However, it is less clear whether and which type of PA and exercise intervention (aerobic exercise, dynamic resistive exercise, or both) or characteristic of exercise (frequency, intensity, time or duration, and volume) would yield more benefit for each separate risk factor. The present paper, therefore, will review and make recommendations for PA and exercise training in the management of cardiovascular health in individuals with cardiovascular risk factors. The guidance offered in this series of papers is aimed at medical doctors, health practitioners, kinesiologists, physiotherapists and exercise physiologists, politicians, public health policy makers, and individual members of the public. Based on previous and the current literature overviews, recommendations from the European Association on Cardiovascular Prevention and Rehabilitation are formulated regarding type, volume, and intensity of PA and regarding appropriate risk evaluation during exercise in individuals with cardiovascular risk factors.

  19. Determination of itopride in human plasma by liquid chromatography coupled to tandem mass spectrometric detection: application to a bioequivalence study.

    Science.gov (United States)

    Lee, Heon-Woo; Seo, Ji-Hyung; Choi, Seung-Ki; Lee, Kyung-Tae

    2007-01-30

    A simple method using a one-step liquid-liquid extraction (LLE) with butyl acetate followed by high-performance liquid chromatography (HPLC) with positive ion electrospray ionization tandem mass spectrometric (ESI-MS/MS) detection was developed for the determination of itopride in human plasma, using sulpiride as an internal standard (IS). Acquisition was performed in multiple reaction monitoring (MRM) mode, by monitoring the transitions: m/z 359.5>166.1 for itopride and m/z 342.3>111.6 for IS, respectively. Analytes were chromatographed on an YMC C18 reverse-phase chromatographic column by isocratic elution with 1 mM ammonium acetate buffer-methanol (20: 80, v/v; pH 4.0 adjusted with acetic acid). Results were linear (r2=0.9999) over the studied range (0.5-1000 ng mL(-1)) with a total analysis time per run of 2 min for LC-MS/MS. The developed method was validated and successfully applied to bioequivalence studies of itopride hydrochloride in healthy male volunteers.

  20. Determination of itopride hydrochloride in human plasma by RP-HPLC with fluorescence detection and its use in bioequivalence study.

    Science.gov (United States)

    Ma, Jing; Yuan, Li-Hua; Ding, Mei-Juan; Zhang, Jun; Zhang, Qing; Xu, Qun-Wei; Zhou, Xue-Min

    2009-03-01

    A sensitive, selective and simple method using a precipitation of protein with 10% perchloric acid, followed by high-performance liquid chromatography (HPLC) with fluorescence detection was developed for the determination of itopride hydrochloride in human plasma, using levofloxacin as the internal standard (IS). Chromatographic separation was obtained within 7.0 min using a reverse phase Hypersil BDS C(18) (250 mm x 4.6 mm, 5 microm) column and an isocratic mobile phase, constituting of a mixture of 0.1 mol/l ammonium acetate-methanol (30:70, v/v) flowing at 1.1 ml/min. The excitation and emission wavelengths were set at 304 and 344 nm, respectively. The method was validated over the concentration range of 5 ng/ml to 1000.0 ng/ml. The lower limit of quantitation (LLOQ) was 5 ng/ml. The extractive recovery of itopride hydrochloride from the biological matrix was more than 80.77%. The intra-day accuracy of the drug containing serum samples was more than 82.94% with a precision of 2.81-4.37%. The inter-day accuracy was 82.91% or more, with a precision of 6.89-9.54%. The limit we have used (70-143%) is based on the local regulatory authority (SFDA). The developed method was validated and successfully applied to bioequivalence studies of itopride hydrochloride in healthy male volunteers.

  1. LC–MS/MS assay for olanzapine in human plasma and its application to a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Dinesh S. Patel

    2012-10-01

    Full Text Available This paper describes a selective and sensitive assay for the determination of olanzapine (OLZ in human plasma based on liquid chromatography–tandem mass spectrometry (LC–MS/MS. The analyte and quetiapine as internal standard (IS were extracted from 200 μL plasma via solid phase extraction on Waters Oasis HLB cartridges. Chromatographic separation was achieved on an ACE 5C18-300 column (100 mm×4.6 mm, 5 μm under isocratic conditions in a run time of 3.5 min. Mass spectrometric detection involved electrospray ionization in the positive ion mode followed by multiple reaction monitoring (MRM of the transitions at m/z 313/256 for OLZ and m/z 384/253 for the IS. The assay was linear in the range 0.10–40.0 ng/mL with a lower limit of quantitation and limit of detection of 0.10 and 0.012 ng/mL, respectively. Intra- and inter-day precision (as coefficient of variation and relative recovery were 90%, respectively. The method was successfully applied to a bioequivalence study of 5 and 10 mg OLZ disintegrating tablets in 40 healthy Indian males with reproducibility by incurred sample reanalysis in the range −7.43 to 8.07%.

  2. Southern San Andreas Fault evaluation field activity: approaches to measuring small geomorphic offsets--challenges and recommendations for active fault studies

    Science.gov (United States)

    Scharer, Katherine M.; Salisbury, J. Barrett; Arrowsmith, J. Ramon; Rockwell, Thomas K.

    2014-01-01

    In southern California, where fast slip rates and sparse vegetation contribute to crisp expression of faults and microtopography, field and high‐resolution topographic data (fault, analyze the offset values for concentrations or trends along strike, and infer that the common magnitudes reflect successive surface‐rupturing earthquakes along that fault section. Wallace (1968) introduced the use of such offsets, and the challenges in interpreting their “unique complex history” with offsets on the Carrizo section of the San Andreas fault; these were more fully mapped by Sieh (1978) and followed by similar field studies along other faults (e.g., Lindvall et al., 1989; McGill and Sieh, 1991). Results from such compilations spurred the development of classic fault behavior models, notably the characteristic earthquake and slip‐patch models, and thus constitute an important component of the long‐standing contrast between magnitude–frequency models (Schwartz and Coppersmith, 1984; Sieh, 1996; Hecker et al., 2013). The proliferation of offset datasets has led earthquake geologists to examine the methods and approaches for measuring these offsets, uncertainties associated with measurement of such features, and quality ranking schemes (Arrowsmith and Rockwell, 2012; Salisbury, Arrowsmith, et al., 2012; Gold et al., 2013; Madden et al., 2013). In light of this, the Southern San Andreas Fault Evaluation (SoSAFE) project at the Southern California Earthquake Center (SCEC) organized a combined field activity and workshop (the “Fieldshop”) to measure offsets, compare techniques, and explore differences in interpretation. A thorough analysis of the measurements from the field activity will be provided separately; this paper discusses the complications presented by such offset measurements using two channels from the San Andreas fault as illustrative cases. We conclude with best approaches for future data collection efforts based on input from the Fieldshop.

  3. USGEO DMWG Cloud Computing Recommendations

    Science.gov (United States)

    de la Beaujardiere, J.; McInerney, M.; Frame, M. T.; Summers, C.

    2017-12-01

    The US Group on Earth Observations (USGEO) Data Management Working Group (DMWG) has been developing Cloud Computing Recommendations for Earth Observations. This inter-agency report is currently in draft form; DMWG hopes to have released the report as a public Request for Information (RFI) by the time of AGU. The recommendations are geared toward organizations that have already decided to use the Cloud for some of their activities (i.e., the focus is not on "why you should use the Cloud," but rather "If you plan to use the Cloud, consider these suggestions.") The report comprises Introductory Material, including Definitions, Potential Cloud Benefits, and Potential Cloud Disadvantages, followed by Recommendations in several areas: Assessing When to Use the Cloud, Transferring Data to the Cloud, Data and Metadata Contents, Developing Applications in the Cloud, Cost Minimization, Security Considerations, Monitoring and Metrics, Agency Support, and Earth Observations-specific recommendations. This talk will summarize the recommendations and invite comment on the RFI.

  4. Bioequivalence of a biosimilar enoxaparin sodium to Clexane® after single 100 mg subcutaneous dose: results of a randomized, double-blind, crossover study in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Martínez González J

    2018-03-01

    Full Text Available Javier Martínez González, Mayte Monreal, Ignacio Ayani Almagia, Jordi Llaudó Garín, Lourdes Ochoa Díaz de Monasterioguren, Ibón Gutierro Adúriz R&D Department, Laboratorios Farmacéuticos Rovi S.A., Madrid, Spain Purpose: To demonstrate the pharmacokinetic/pharmacodynamic (PK/PD equivalence of a biosimilar enoxaparin to the reference drug, and to assess its safety and tolerability in healthy volunteers. Patients and methods: A randomized, double-blind, crossover, 2-sequence, single-dose study was conducted in healthy volunteers of both sexes. Participants were sequentially and randomly administered single subcutaneous injections of enoxaparin 100 mg manufactured by Rovi (test; Madrid, Spain and Clexane® (enoxaparin 100 mg manufactured by Sanofi, reference separated by a 1-week washout period. The primary PK/PD variables were maximum activity (Amax and area under the effect curve from time 0 to the last measured activity (T (AUEC0–T and AUEC from time 0 to infinity (AUEC0–inf of anti-FXa activity, and Amax and AUEC0–T of anti-FIIa activity. Secondary variables were Amax and AUEC0–T, AUEC0–inf of tissue factor pathway inhibitor, and the ratio of AUEC0–T anti-FXa to anti-FIIa activity. Biosimilarity would be shown when the 95% CI of the ratio of geometric least squares means (95% CI RGLSMs of primary PK/PD parameters fell within the standard range of bioequivalence, ie, 80%–125%.Results: The study sample consisted of 46 volunteers (33 males aged 18–44 years and with body mass index ranging from 19.0 to 31.1 kg/m2. Three subjects did not complete the study. The curves of anti-FXa, anti-FIIa and tissue factor pathway inhibitor activities corresponding to administration of the test and reference products were comparable. The 95% CI RGLSMs of Amax, AUEC0–T and AUEC0–inf for anti-FXa activity were 94.6%–105.9%, 99.8%–108.0% and 100.0%–108.6% respectively; Amax and AUEC0–T for anti-FIIa activity were 94.7%–112.6% and

  5. Towards an energy transition? Which energies for tomorrow and for all, on the territory. Research-action, problematic note - Activity report 2012-2014 - Final report. Citizen recommendations

    International Nuclear Information System (INIS)

    Aubin, Samuel; Lemoult, Bernard; Allagnat, Bernard; Cohu, Sylvie; Gadoin, Emilie; Crochet, Moise; Dothee, Jean-Luc; Gauduchon, Marie-Veronique; Gendre, Nicolas; Musard, Denis; Retiere, Alain; Vacher, Pierre; Vilbert, Christine; Petillon, Xavier; Damerose, Clotilde

    2014-11-01

    This document first presents a project launched on the issue of energy choice for tomorrow for the territory, and more particularly on a shared regional diagnosis and principles for action. A second document reports activities of this research-action project which aimed at making citizen recommendations emerge, and at elaborating an operational territorial tool for energy transition. Then comes the final report of this project. After an introduction which outlines that energy transition is a major stake for the territory, a first chapter discusses which are tomorrow's energies by outlining the climatic emergency, the energy situation at the world level, the perspective of smart cities and communities, national energetic stakes, the role given to citizen, and the perspective of a new relationship to the world and to the nature. The second chapter briefly evokes the perspective for 2050. The next part discusses the societal dimension of energy transition, and examines what could be the engines for change. The next chapter identifies and discusses various debates to be held: on climate situation, on energy resource availability, on human development and on the economic model. The last chapter outlines the role of the territorial scale and of collective dynamics to elaborate and implement scenarios of energy transition

  6. Prevalence and correlates of achieving recommended physical activity levels among children living in rural South Asia—A multi-centre study

    Directory of Open Access Journals (Sweden)

    Krithiga Shridhar

    2016-08-01

    Full Text Available Abstract Background We report the prevalence of recommended physical activity levels (RPALs and examine the correlates of achieving RPALs in rural South Asian children and analyse its association with anthropometric outcomes. Methods This analysis on rural South Asian children aged 5–14 years (n = 564 is a part of the Chronic Disease Risk Factor study conducted at three sites in India (Chennai n = 146; Goa n = 218 and Bangladesh (Matlab; n = 200. Data on socio-demographic and lifestyle factors (physical activity (PA; diet were collected using an interviewer-administered questionnaires, along with objective anthropometric measurements. Multivariate logistic regression models were used to examine whether RPALs (active travel to school (yes/no; leisure-time PA ≥ 1 h/day; sedentary-activity ≤ 2 h/day were associated with socio-demographic factors, diet and other forms of PA. Multivariate linear regression models were used to investigate associations between RPALs and anthropometrics (BMI- and waist z-scores. Results The majority of children (71.8 % belonged to households where a parent had at least a secondary education. Two-thirds (66.7 % actively travelled to school; 74.6 % reported ≥1 h/day of leisure-time PA and 55.7 % had ≤2 h/day of sedentary-activity; 25.2 % of children reported RPALs in all three dimensions. Older (10–14 years, OR = 2.0; 95 % CI: 1.3, 3.0 and female (OR = 1.7; 95 % CI: 1.1, 2.5 children were more likely to travel actively to school. Leisure-time PA ≥ 1 h/day was more common among boys (OR = 2.5; 95 % CI: 1.5, 4.0, children in Matlab, Bangladesh (OR = 3.0; 95 % CI: 1.6, 5.5, and those with higher processed-food consumption (OR = 2.3; 95 % CI: 1.2, 4.1. Sedentary activity ≤ 2 h/day was associated with younger children (5–9 years, OR = 1.6; 95 % CI: 1.1, 2.4, children of Goa (OR = 3.5; 95 % CI: 2.1, 6.1 and Chennai (OR = 2.5; 95

  7. Prevalence and correlates of achieving recommended physical activity levels among children living in rural South Asia-A multi-centre study.

    Science.gov (United States)

    Shridhar, Krithiga; Millett, Christopher; Laverty, Anthony A; Alam, Dewan; Dias, Amit; Williams, Joseph; Dhillon, Preet K

    2016-08-02

    We report the prevalence of recommended physical activity levels (RPALs) and examine the correlates of achieving RPALs in rural South Asian children and analyse its association with anthropometric outcomes. This analysis on rural South Asian children aged 5-14 years (n = 564) is a part of the Chronic Disease Risk Factor study conducted at three sites in India (Chennai n = 146; Goa n = 218) and Bangladesh (Matlab; n = 200). Data on socio-demographic and lifestyle factors (physical activity (PA); diet) were collected using an interviewer-administered questionnaires, along with objective anthropometric measurements. Multivariate logistic regression models were used to examine whether RPALs (active travel to school (yes/no); leisure-time PA ≥ 1 h/day; sedentary-activity ≤ 2 h/day) were associated with socio-demographic factors, diet and other forms of PA. Multivariate linear regression models were used to investigate associations between RPALs and anthropometrics (BMI- and waist z-scores). The majority of children (71.8 %) belonged to households where a parent had at least a secondary education. Two-thirds (66.7 %) actively travelled to school; 74.6 % reported ≥1 h/day of leisure-time PA and 55.7 % had ≤2 h/day of sedentary-activity; 25.2 % of children reported RPALs in all three dimensions. Older (10-14 years, OR = 2.0; 95 % CI: 1.3, 3.0) and female (OR = 1.7; 95 % CI: 1.1, 2.5) children were more likely to travel actively to school. Leisure-time PA ≥ 1 h/day was more common among boys (OR = 2.5; 95 % CI: 1.5, 4.0), children in Matlab, Bangladesh (OR = 3.0; 95 % CI: 1.6, 5.5), and those with higher processed-food consumption (OR = 2.3; 95 % CI: 1.2, 4.1). Sedentary activity ≤ 2 h/day was associated with younger children (5-9 years, OR = 1.6; 95 % CI: 1.1, 2.4), children of Goa (OR = 3.5; 95 % CI: 2.1, 6.1) and Chennai (OR = 2.5; 95 % CI: 1.5, 4.3) and low household education

  8. Is adherence to diet, physical activity, and body weight cancer prevention recommendations associated with colorectal cancer incidence in African American women?

    Science.gov (United States)

    Nomura, Sarah J O; Dash, Chiranjeev; Rosenberg, Lynn; Yu, Jeffrey; Palmer, Julie R; Adams-Campbell, Lucile L

    2016-07-01

    The purpose of this study was to evaluate whether adherence to the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) cancer prevention recommendations was associated with colorectal cancer incidence in the Black Women's Health Study (BWHS). In this ongoing prospective cohort of African American women (analytic cohort n = 49,103), 354 incident colorectal cancers were diagnosed between baseline (1995) and 2011. Adherence scores for seven WCRF/AICR recommendations (adherent = 1 point, non-adherent level 1 = 0.5 points, non-adherent level 2 = 0 points) were created using questionnaire data and summed to an overall adherence score (maximum = 7). Recommendation adherence and colorectal cancer incidence were evaluated using baseline and time-varying data in Cox regression models. At baseline, 8.5 % of women adhered >4 recommendations. In time-varying analyses, the HR was 0.98 (95 % CI 0.84-1.15) per 0.5 point higher score and 0.51 (95 % CI 0.23-1.10) for adherence to >4 compared to <3 recommendations. Adherence to individual recommendations was not associated with colorectal cancer risk. Results were similar in models that considered baseline exposures only. Adherence to cancer prevention recommendations was low and not associated with colorectal cancer risk among women in the BWHS. Research in diverse populations is essential to evaluate the validity of existing recommendations, and assess whether there are alternative recommendations that are more beneficial for cancer prevention in specific populations.

  9. Bioequivalence and food effect assessment for vildagliptin/metformin fixed-dose combination tablets relative to free combination of vildagliptin and metformin in Japanese healthy subjects.

    Science.gov (United States)

    Mita, Sachiko; Chitnis, Shripad D; Kulmatycki, Kenneth; Salunke, Atish; He, Yan-Ling; Zhou, Wei; Suzuki, Hikoe

    2016-04-01

    To assess the bioequivalence of vildagliptin/metformin fixeddose combination (FDC) tablets (50/250 mg and 50/500 mg) to free combinations of vildagliptin and metformin and the effect of food on the pharmacokinetics (PK) of vildagliptin and metformin following administration of 50/500 mg FDC tablets. Two openlabel, randomized, single-center, singledose, 2-period crossover studies were conducted in Japanese healthy male volunteers. Participants were administered vildagliptin/ metformin FDC tablets (study I: 50/250 mg, study II: 50/500 mg) or their free combinations under fasted condition. Food effect (standard Japanese breakfast: fat, 20 - 30% with ~ 600 kcal in total) was assessed during an additional period in study II (50/500 mg). PK parameters (AUC, C(max), t(max), t(1/2)) were calculated for vildagliptin and metformin. In both studies, vildagliptin/metformin FDC tablets were bioequivalent to their respective free combinations. Administration of FDC tablets after meals had no effect on vildagliptin PK parameters. The rate of absorption of metformin decreased when administered under fed condition, as reflected by a prolonged t(max) (3 hours in fasted state vs. 4 hours in fed state) and decrease in C(max) by 26%, however, the extent of absorption (AUC(last)) was similar to that in the fasted state. Vildagliptin/metformin FDC tablets were bioequivalent to their free combinations. Food decreased the C(max) of metformin by 26%, while AUC(last) was unchanged, consistent with previous reports. No food effect was observed on the C(max) or AUC(last) of vildagliptin. Thus, food had no clinically relevant effects on the PK of metformin or vildagliptin.

  10. Large-volume injection of sample diluents not miscible with the mobile phase as an alternative approach in sample preparation for bioanalysis: an application for fenspiride bioequivalence.

    Science.gov (United States)

    Medvedovici, Andrei; Udrescu, Stefan; Albu, Florin; Tache, Florentin; David, Victor

    2011-09-01

    Liquid-liquid extraction of target compounds from biological matrices followed by the injection of a large volume from the organic layer into the chromatographic column operated under reversed-phase (RP) conditions would successfully combine the selectivity and the straightforward character of the procedure in order to enhance sensitivity, compared with the usual approach of involving solvent evaporation and residue re-dissolution. Large-volume injection of samples in diluents that are not miscible with the mobile phase was recently introduced in chromatographic practice. The risk of random errors produced during the manipulation of samples is also substantially reduced. A bioanalytical method designed for the bioequivalence of fenspiride containing pharmaceutical formulations was based on a sample preparation procedure involving extraction of the target analyte and the internal standard (trimetazidine) from alkalinized plasma samples in 1-octanol. A volume of 75 µl from the octanol layer was directly injected on a Zorbax SB C18 Rapid Resolution, 50 mm length × 4.6 mm internal diameter × 1.8 µm particle size column, with the RP separation being carried out under gradient elution conditions. Detection was made through positive ESI and MS/MS. Aspects related to method development and validation are discussed. The bioanalytical method was successfully applied to assess bioequivalence of a modified release pharmaceutical formulation containing 80 mg fenspiride hydrochloride during two different studies carried out as single-dose administration under fasting and fed conditions (four arms), and multiple doses administration, respectively. The quality attributes assigned to the bioanalytical method, as resulting from its application to the bioequivalence studies, are highlighted and fully demonstrate that sample preparation based on large-volume injection of immiscible diluents has an increased potential for application in bioanalysis.

  11. Relative bioequivalence evaluation of two oral atomoxetine hydrochloride capsules: a single dose, randomized, open-label, 2-period crossover study in healthy Chinese volunteers under fasting conditions.

    Science.gov (United States)

    Shang, D-W; Guo, W; Zhou, F-C; Wang, X-P; Li, A-N; Zhang, L; Li, W-B; Lu, W; Wang, C-Y

    2013-11-01

    To evaluate the bioequivalence of a new formulation of atomoxetine hydrochloride (CAS 82248-59-7) capsules (test) and an available branded capsules (reference) after administration of a single 40 mg dose, randomized, open-label, 2-period crossover study was conducted in 22 healthy male Chinese subjects with a 1-week wash-out period. This study was designed for/the Honglin Pharmaceutical Co. Ltd and contracted to be done by the Beijing Anding Hospital in order to satisfy Chinese regulatory requirements to allow marketing of this generic product and performed according to the criteria of SFDA. Blood samples were collected before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16 and 24 h after drug administration. Plasma concentrations were determined by high-performance liquid chromatography (HPLC) with UV detection. A non-compartmental method was used to calculate the pharmacokinetic parameters and evaluate bioequivalence of the 2 formulations. The 90% confidence interval (CI) of the ratios (test/reference) of atomoxetine for AUC0-24, AUC0-∞ and Cmax were 100.9% (93.6-108.8%), 103.1% (95.1-111.7%) and 105.2% (92.8-119.4%), respectively, which fell within the interval of 80-125% and 75-133%. No clinically significant changes or abnormalities were noted in laboratory data and vital signs. From these results it can be concluded that the test formulation of atomoxetine capsules met the regulatory criterion for bioequivalence to the reference formulation. © Georg Thieme Verlag KG Stuttgart · New York.

  12. Bioequivalence of 2 Formulations of Sildenafil Oral Soluble Film 100 mg and Sildenafil Citrate (Viagra) 100 mg Oral Tablets in Healthy Male Volunteers.

    Science.gov (United States)

    Dadey, Eric

    Sildenafil citrate tablets (VIAGRA; Pfizer Inc) have been used since 1998 as an oral therapy for the treatment of erectile dysfunction. However, in some cases, patients may have difficulty in swallowing tablets, and the need to use water to aid in the oral administration of the tablets has the potential to interrupt the sexual encounter, reduce spontaneity, and therefore decrease the quality of the experience. Two oral soluble film (OSF) formulations of sildenafil were developed using MonoSol Rx's proprietary PharmFilm technology. Both films were formulated to dissolve rapidly on the tongue, thereby releasing the drug into the oral cavity, whereupon it is swallowed without the use of water. From a patient perspective, it is anticipated that the film formulations of sildenafil citrate will provide a more compliant and discreet dosage form. The purpose of this clinical study was to compare the bioequivalence of the 2 sildenafil OSF 100 mg formulations (MonoSol Rx, LLC) with the sildenafil citrate 100 mg tablets. The design was a single-dose, randomized, open-label, 3-period, 6-sequence, 3-treatment, single-center, crossover study conducted in 18 healthy, nonsmoking male volunteers under fasting conditions, with each treatment period separated by a 7-day washout period. Plasma sildenafil concentrations were measured predose and then periodically to 24 hours after dosing. The 90% confidence intervals for plasma sildenafil AUC0-t, AUC0-∞, and Cmax for both sildenafil OSF formulations as compared with sildenafil citrate tablets were all within the 80%-125% range, indicating bioequivalence of both film formulations to sildenafil citrate tablets. Overall, the demonstrated bioequivalence coupled with the performance advantages of an OSF dosage form (ie, rapid dissolution in the mouth, can be taken without water, and can be dosed discreetly) suggest that the sildenafil OSF may provide an attractive alternative to sildenafil citrate oral tablets.

  13. Sodium ferric gluconate (SFG) in complex with sucrose for IV infusion: bioequivalence of a new generic product with the branded product in healthy volunteers.

    Science.gov (United States)

    Baribeault, David

    2011-08-01

    Parenteral sodium ferric gluconate in complex (Ferrlecit [branded SFG]) is used to treat patients with iron deficiency anemia undergoing chronic hemodialysis and receiving supplemental epoetin. This comparative pharmacokinetic study (GeneraMedix, Inc., Study 17909) evaluates whether the recently approved generic product Nulecit (generic SFG) and the branded product Ferrlecit (branded SFG) are bioequivalent. In this open-label study, 240 healthy volunteers in a fasting state were assigned randomly to a single 10-min intravenous (IV) infusion of 125 mg of generic or branded SFG. Total and transferrin-bound iron concentrations were determined for the 36-h period after infusion and corrected for pretreatment levels. Maximum concentration (Cmax) and area under the concentration-time curve of 0 to 36 h (AUC[0-36]) were compared between the two products. Demonstration of bioequivalence required that the 90% confidence intervals of each parameter evaluated for generic SFG were within 80% to 125% of the corresponding values for branded SFG. Uncorrected and baseline-corrected mean serum concentrations of total serum iron during the 36-h assessment period were similar for generic and branded SFG. For total serum iron, the geometric mean ratios of corrected Cmax and AUC[0-36] were 100%. For transferrin-bound iron, the geometric mean ratios were 87% for corrected Cmax and 92% for corrected AUC[0-36]. All associated 90% confidence intervals were within the range of 80% to 125%. A new generic SFG in complex for IV infusion is bioequivalent to the branded SFG in complex for IV infusion. The generic SFG is AB rated by the FDA and considered therapeutically equivalent to the branded product.

  14. Determination of levodopa in human plasma by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS: application to a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Heliana F. Martins

    2013-01-01

    Full Text Available A sensitive, accurate and simple method using HPLC-MS/MS was developed and validated for levodopa quantitation in human plasma. Analysis was achieved on a pursuit® C18 analytical column (5 µm; 150 x 4.6 mm i.d. using a mobile phase (methanol and water , 90:10, v/v containing formic acid 0.5% v/v, after extracting the samples using a simple protein plasma precipitation with perchloric acid. The developed method was validated in accordance with ANVISA guidelines and was successfully applied to a bioequivalence study in 60 healthy volunteers demonstrating the feasibility and reliability of the proposed method.

  15. Bioequivalence of 250 mg lysine clonixinate tablets after a single oral dose in a healthy female Mexican population under fasting conditions.

    Science.gov (United States)

    Marcelín-Jiménez, G; Angeles, A C P; García, A; Morales, M; Rivera, L; Martín-Del-Campo, A

    2010-05-01

    To evaluate the bioequivalence between two 250 mg-tablets of lysine clonixinate, Dorixina Forte (Siegfried Rhein, México) as reference product, and Prestodol (Farmaceúticos Rayere, S.A., México) as test formulation. 26 healthy adult female Mexican volunteers received a single oral dose of 250-mg lysine clonixinate under fasting conditions. The drug was administered following a randomized, two-period, two-sequence, cross-over design. Twelve serial blood samples were collected up to 8 h after dosing, and clonixin (CLX) was measured by ultra-performance liquid chromatography (UPLC) coupled with tandem mass spectrometry. Decimal logarithm values of Cmax and area under the curve (AUC) were used to construct a classic confidence interval at 90% (90% CI). Bioequivalence was established if 90% CI of mean ratios (test/reference) fall within the 0.8-1.25 range. Volunteers formed a homogeneous population in terms of age (27.2 +/- 6.3 years), weight (55.9 +/- 6.5 kg), height (1.6 +/- 0.04 m), and body mass index (BMI) (22.91 +/- 2.03 kg/m(2)). Reference formulation exhibited the following pharmacokinetics: C(max) (32.39 +/- 8.32 microg/ml); t(max) (0.64 +/- 0.2 h); AUC0-8h (48.92 +/- 16.51 microg x h/ml); t1/2 (1.3 +/- 0.24 h); CLapp (5.64 +/- 1.99 l/h), and Vdapp (10.22 +/- 2.9 l). Concerning bioequivalence, 90% CI were: C(max) (82.32 - 98.79), AUC0-t (94.59-106.29), and AUC(0-inf) (94.61-106.42), with a statistical power of > 0.90 at every tested interval. This single-dose study found that both 250-mg immediate-release tablets of lysine clonixinate met the Mexican regulatory criteria for bioequivalence in these volunteers.

  16. Rapid determination of telmisartan in human plasma by HPLC using a monolithic column with fluorescence detection and its application to a bioequivalence study.

    Science.gov (United States)

    Zhang, He; Jiang, Yunyun; Wen, Jun; Zhou, Tingting; Fan, Guorong; Wu, Yutian

    2009-11-01

    A rapid HPLC method using a monolithic column with fluorescence detection has been developed for determination of telmisartan in human plasma. Sample preparation was done by protein precipitation with acetonitrile and naproxen was used as IS. The compounds were detected by fluorescence detection, using an excitation wavelength of 300 nm and emission wavelength of 385 nm. Calibration curves of telmisartan were linear in the range of 1-200 ng/mL. The assay was high throughput, sensitive and precise, and it was successfully applied to a bioequivalence study of two formulations of telmisartan.

  17. Estudio de bioequivalencia de dos formulaciones de tabletas de carbamazepina de liberación retardada Study of bioequivalence of two carbamazepine retard-release tablet formulations

    Directory of Open Access Journals (Sweden)

    2000-03-01

    Full Text Available En 12 voluntarios sanos se efectuó un estudio de bioequivalencia de dos preparados comerciales de carbamazepina en tabletas de liberación retardada. Este estudio permitió comparar la biodisponibilidad de la formulación de referencia Tegretol® Retard de Ciba Geigy elaborado en Colombia por Novartis, y la formulación de prueba Carbamazepina MK Retard, de Tecnoquímicas. Para evaluar la bioequivalencia se determinaron las curvas de concentración plasmática vs tiempo de las dos formulaciones y se calcularon las áreas bajo la curva (AUC y las concentraciones máximas (Cmáx. Para la formulación de prueba el intervalo de confianza del 90% para el AUC estuvo entre 95.7 y 100.7% y para el C(máx entre el 88.6 y el 106.1%. Para ambas determinaciones el rango de aceptación, según normas internacionales, está entre 80 y 125% de la formulación de referencia. Esto demuestra la bioequivalencia de las dos formulaciones. A study of the bioequivalence of two comercial carbamazepine retard-release formulations was carried out in 12 healthy volunteers. Studies of bioequivalence allow to compare the bioavailability of the innovator formulation with generic, alternative or branch formulations. In order to evaluate the bioequivalence, plasma carbamazepine concentration/time curves were obtained for the Tegretol® Retard Tablets –reference formulationand for the test formulation; the area under each curve and the maximum concentration were calculated. After the calculation, statistical analysis of data for the area under the curve of the Carbamazepine Retard Tablets –test formulation, was between 95.7% and 100.7 % and the maximum concentration of the test formulation was between 88.6% and 106.1%; both parameters with the 90% confidence interval. Since the acceptance range was determined to be between 80.0% and 125.0% of the reference formulation, we concluded from this study that the two formulations are bioequivalent.

  18. Avoiding congestion in recommender systems

    International Nuclear Information System (INIS)

    Ren, Xiaolong; Lü, Linyuan; Liu, Runran; Zhang, Jianlin

    2014-01-01

    Recommender systems use the historical activities and personal profiles of users to uncover their preferences and recommend objects. Most of the previous methods are based on objects’ (and/or users’) similarity rather than on their difference. Such approaches are subject to a high risk of increasingly exposing users to a narrowing band of popular objects. As a result, a few objects may be recommended to an enormous number of users, resulting in the problem of recommendation congestion, which is to be avoided, especially when the recommended objects are limited resources. In order to quantitatively measure a recommendation algorithm's ability to avoid congestion, we proposed a new metric inspired by the Gini index, which is used to measure the inequality of the individual wealth distribution in an economy. Besides this, a new recommendation method called directed weighted conduction (DWC) was developed by considering the heat conduction process on a user–object bipartite network with different thermal conductivities. Experimental results obtained for three benchmark data sets showed that the DWC algorithm can effectively avoid system congestion, and greatly improve the novelty and diversity, while retaining relatively high accuracy, in comparison with the state-of-the-art methods. (paper)

  19. Semantically Enhanced Recommender Systems

    Science.gov (United States)

    Ruiz-Montiel, Manuela; Aldana-Montes, José F.

    Recommender Systems have become a significant area in the context of web personalization, given the large amount of available data. Ontologies can be widely taken advantage of in recommender systems, since they provide a means of classifying and discovering of new information about the items to recommend, about user profiles and even about their context. We have developed a semantically enhanced recommender system based on this kind of ontologies. In this paper we present a description of the proposed system.

  20. No time for the gym? Housework and other non-labor market time use patterns are associated with meeting physical activity recommendations among adults in full-time, sedentary jobs.

    Science.gov (United States)

    Smith, Lindsey P; Ng, Shu Wen; Popkin, Barry M

    2014-11-01

    Physical activity and inactivity have distinct cardio-metabolic consequences, suggesting that combinations of activities can impact health above and beyond the effects of a single activity. However, little work has examined patterns of non-labor market time activity in the US population, particularly among full-time employees in sedentary occupations, who are at increased risk of adverse health consequences associated with a sedentary lifestyle. Identification of these patterns, and how they are related to total physical activity levels, is important for developing effective, attainable physical activity recommendations among sedentary employees, who typically have less time available for exercise. This is especially the case for low-income employees who face the highest time and financial barriers to achieving physical activity goals. This study uses cluster analysis to examine patterns of non-labor market time use among full-time (≥40 h/week) employed adults in sedentary occupations (working days in the American Time Use Study. We then examine whether these patterns are associated with higher likelihood of meeting physical activity recommendations and higher overall physical activity (MET-h). We find that non-labor market time use patterns include those characterized by screen activities, housework, caregiving, sedentary leisure, and exercise. For both genders, the screen pattern was the most common and increased from 2003 to 2012, while the exercise pattern was infrequent and consistent across time. Screen, sedentary leisure, and community patterns were associated with lower likelihoods of meeting physical activity recommendations, suggesting that interventions targeting screen time may miss opportunities to improve physical activity among similarly sedentary groups. Alternately, non-labor market time use patterns characterized by housework and caregiving represented feasible avenues for increasing overall physical activity levels, especially for those with

  1. Trust for intelligent recommendation

    CERN Document Server

    Bhuiyan, Touhid

    2013-01-01

    Recommender systems are one of the recent inventions to deal with the ever-growing information overload in relation to the selection of goods and services in a global economy. Collaborative Filtering (CF) is one of the most popular techniques in recommender systems. The CF recommends items to a target user based on the preferences of a set of similar users known as the neighbors, generated from a database made up of the preferences of past users. In the absence of these ratings, trust between the users could be used to choose the neighbor for recommendation making. Better recommendations can b

  2. Evaluation of two novel tablet formulations of artemether-lumefantrine (Coartem) for bioequivalence in a randomized, open-label, two-period study.

    Science.gov (United States)

    Lefèvre, Gilbert; Bhad, Prafulla; Jain, Jay Prakash; Kalluri, Sampath; Cheng, Yi; Dave, Hardik; Stein, Daniel S

    2013-09-08

    Artemether-lumefantrine (Coartem; AL) is a standard of care for malaria treatment as an oral six-dose regimen, given twice daily over three days with one to four tablets (20/120 mg) per dose, depending on patient body weight. In order to reduce the pill burden at each dose and potentially enhance compliance, two novel fixed-dose tablet formulations (80/480 mg and 60/360 mg) have been developed and tested in this study for bioequivalence with their respective number of standard tablets. A randomized, open-label, two-period, single-dose, within formulation crossover bioequivalence study comparing artemether and lumefantrine exposure between the novel 80/480 mg tablet and four standard tablets, and the novel 60/360 mg tablet and three standard tablets, was conducted in 120 healthy subjects under fed conditions. Artemether, dihydroartemisinin, and lumefantrine were measured in plasma by HPLC/UPLC-MS/MS. Pharmacokinetic (PK) parameters were determined by non-compartmental analyses. Adjusted geometric mean AUClast for artemether were 345 and 364 ng·h/mL (geometric mean ratio (GMR) 0.95; 90% CI 0.89-1.01) and for lumefantrine were 219 and 218 μg·h/mL (GMR 1.00; 90% CI 0.93-1.08) for 80/480 mg tablet versus four standard tablets, respectively. Corresponding Cmax for artemether were 96.8 and 99.7 ng/mL (GMR 0.97; 90% CI 0.89-1.06) and for lumefantrine were 8.42 and 8.71 μg/mL (GMR 0.97; 90% CI 0.89-1.05). For the 60/360 mg tablet versus three standard tablets, adjusted geometric mean AUClast for artemether were 235 and 231 ng·h/mL (GMR 1.02; 90% CI 0.94-1.10), and for lumefantrine were 160 and 180 μg·h/mL (GMR 0.89; 90% CI 0.83-0.96), respectively. Corresponding Cmax for artemether were 75.5 and 71.5 ng/mL (GMR 1.06; 90% CI 0.95-1.18), and for lumefantrine were 6.64 and 7.61 μg/mL (GMR 0.87; 90% CI 0.81-0.94), respectively. GMR for Cmax and AUClast for artemether and lumefantrine for all primary comparisons were within the bioequivalence acceptance criteria (0

  3. Random-effects linear modeling and sample size tables for two special crossover designs of average bioequivalence studies: the four-period, two-sequence, two-formulation and six-period, three-sequence, three-formulation designs.

    Science.gov (United States)

    Diaz, Francisco J; Berg, Michel J; Krebill, Ron; Welty, Timothy; Gidal, Barry E; Alloway, Rita; Privitera, Michael

    2013-12-01

    Due to concern and debate in the epilepsy medical community and to the current interest of the US Food and Drug Administration (FDA) in revising approaches to the approval of generic drugs, the FDA is currently supporting ongoing bioequivalence studies of antiepileptic drugs, the EQUIGEN studies. During the design of these crossover studies, the researchers could not find commercial or non-commercial statistical software that quickly allowed computation of sample sizes for their designs, particularly software implementing the FDA requirement of using random-effects linear models for the analyses of bioequivalence studies. This article presents tables for sample-size evaluations of average bioequivalence studies based on the two crossover designs used in the EQUIGEN studies: the four-period, two-sequence, two-formulation design, and the six-period, three-sequence, three-formulation design. Sample-size computations assume that random-effects linear models are used in bioequivalence analyses with crossover designs. Random-effects linear models have been traditionally viewed by many pharmacologists and clinical researchers as just mathematical devices to analyze repeated-measures data. In contrast, a modern view of these models attributes an important mathematical role in theoretical formulations in personalized medicine to them, because these models not only have parameters that represent average patients, but also have parameters that represent individual patients. Moreover, the notation and language of random-effects linear models have evolved over the years. Thus, another goal of this article is to provide a presentation of the statistical modeling of data from bioequivalence studies that highlights the modern view of these models, with special emphasis on power analyses and sample-size computations.

  4. Bioequivalence of Liposome-Entrapped Paclitaxel Easy-To-Use (LEP-ETU) formulation and paclitaxel in polyethoxylated castor oil: a randomized, two-period crossover study in patients with advanced cancer.

    Science.gov (United States)

    Slingerland, Marije; Guchelaar, Henk-Jan; Rosing, Hilde; Scheulen, Max E; van Warmerdam, Laurence J C; Beijnen, Jos H; Gelderblom, Hans

    2013-12-01

    Preclinical studies comparing paclitaxel formulated with polyethoxylated castor oil with the sonicated formulation of liposome-entrapped paclitaxel (LEP) have demonstrated that LEP was associated with reduced toxicity while maintaining similar efficacy. Preliminary studies on the pharmacokinetics in patients support earlier preclinical data, which suggested that the LEP Easy-to-Use (LEP-ETU) formulation and paclitaxel formulated with castor oil may have comparable pharmacokinetic properties. Our objectives were: (1) to determine bioequivalence of paclitaxel pharmaceutically formulated as LEP-ETU (test) and paclitaxel formulated with castor oil (reference); and (2) to assess the tolerability of LEP-ETU following intravenous administration. Patients with advanced cancer were studied in a randomized, 2-period crossover bioequivalence study. Patients received paclitaxel 175 mg/m(2) administered as an intravenous infusion over 180 minutes, either as a single-treatment cycle of the test formulation followed by a single-treatment cycle of the reference formulation, or vice versa. Thirty-two of 58 patients were evaluable and were included in the analysis for bioequivalence. Mean total paclitaxel Cmax values for the test and reference formulations were 4955.0 and 5108.8 ng/mL, respectively. Corresponding AUC0-∞ values were 15,853.8 and 18,550.8 ng·h/mL, respectively. Treatment ratios of the geometric means were 97% (90% CI, 91%-103%) for Cmax and 84% (90% CI, 80%-90%) for AUC0-∞. These results met the required 80% to 125% bioequivalence criteria. The most frequently reported adverse events after LEP-ETU administration were fatigue, alopecia, and myalgia. At the studied dose regimen, LEP-ETU showed bioequivalence with paclitaxel formulated with polyethoxylated castor oil. © 2013 Elsevier HS Journals, Inc. All rights reserved.

  5. The new ICRP general recommendations

    International Nuclear Information System (INIS)

    Mason, Ch.; Kosako, T.; Kuniyoshi, H.; Kiryu, Y.; Choi, H.S.; Burns, P.A.; Pan, Z.Q.; Xia, Y.

    2007-01-01

    Regulatory views from Japan, South Korea, Australia, China and Indonesia were explained based on their regional context. Some issues, for example 'optimisation', 'dose constrains', 'natural radioactivity', were addressed from the viewpoint of how each country's current regulation system would adopt these new recommendations. It was noted that there would be a need for some flexibility in applying these new recommendations since different countries have different regulatory criteria and benchmarks as well different decision-making processes. It was also noted that definitions and terminologies should be given serious consideration with regard to non-English speaking countries to assure that the new ICRP recommendations are clearly understood, not misinterpreted, easily translated and finally applied in the field of radiation protection. In addition, some recent radiation protection activities, as well as views on utilisation of nuclear power in several countries were presented. (authors)

  6. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...

  7. Bioequivalence study of a new sildenafil 100 mg orodispersible film compared to the conventional film-coated 100 mg tablet administered to healthy male volunteers

    Directory of Open Access Journals (Sweden)

    Radicioni M

    2017-04-01

    Full Text Available Milko Radicioni,1 Chiara Castiglioni,1 Andrea Giori,2 Irma Cupone,3 Valeria Frangione,4 Stefano Rovati4 1CROSS Research S.A., Phase I Unit, Arzo, Switzerland; 2IBSA Farmaceutici Italia, Lodi, Italy; 3Bouty S.p.A., Strada Padana Superiore, Cassina De’ Pecchi, Italy; 4IBSA Institut Biochimique S.A., Pambio-Noranco, Switzerland Abstract: A new orodispersible film formulation of the phosphodiesterase type 5 inhibitor, sildenafil, has been developed to examine the advantages of an orally disintegrating film formulation and provide an alternative to the current marketed products for the treatment of erectile dysfunction. The pharmacokinetics of the sildenafil 100 mg orodispersible film (IBSA was compared to that of the conventional marketed 100 mg film-coated tablet (Viagra® after single-dose administration to 53 healthy male volunteers (aged 18–51 years in a randomized, open, two-way crossover bioequivalence study. Each subject received a single oral dose of 100 mg of sildenafil as test or reference formulation administered under fasting conditions at each of the two study periods according to a randomized crossover design. There was a washout interval of ≥7 days between the two administrations of the investigational medicinal products. Blood samples for pharmacokinetic analysis were collected up to 24 h post-dosing. The primary objective was to compare the rate (peak plasma concentration; Cmax and extent (area under the curve [AUC] from administration to last observed concentration time; AUC0–t of sildenafil absorption after single-dose administration of test and reference. Secondary endpoints were observed to describe the plasma pharmacokinetic profiles of sildenafil and its metabolite N-desmethyl-sildenafil relative bioavailability and safety profile after single-dose administration. The mean sildenafil and N-desmethyl-sildenafil plasma concentration–time profiles up to 24 h after single-dose administration of sildenafil 100 mg

  8. Family Shopping Recommendation System Using User Profile and Behavior Data

    OpenAIRE

    Jiacheng, Xu

    2017-01-01

    With the arrival of the big data era, recommendation system has been a hot technology for enterprises to streamline their sales. Recommendation algorithms for individual users have been extensively studied over the past decade. Most existing recommendation systems also focus on individual user recommendations, however in many daily activities, items are recommended to the groups not one person. As an effective means to solve the problem of group recommendation problem,we extend the single use...

  9. 1990 recommendations of ICRP

    International Nuclear Information System (INIS)

    Clarke, R.H.

    1991-01-01

    The Main Commission of ICRP finalised its new recommendations during its November 1990 meeting. The recommendations will appear in the Annals of the ICRP in 1991 as Publication 60. This paper represents a personal summary of these recommendations. It covers the basic biological risk estimates and the conceptual framework of the system of radiological protection, the definition of radiation detriment and its use both in the definition of radiation quantities and in the establishment of the dose limits adopted by the Main Commissions. (author)

  10. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

    Science.gov (United States)

    2010-09-29

    The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

  11. Bioequivalence of generic lamotrigine 100-mg tablets in healthy Thai male volunteers: a randomized, single-dose, two-period, two-sequence crossover study.

    Science.gov (United States)

    Srichaiya, Arunee; Longchoopol, Chaowanee; Oo-Puthinan, Sarawut; Sayasathid, Jarun; Sripalakit, Pattana; Viyoch, Jarupa

    2008-10-01

    Lamotrigine is an antiepileptic drug which has been used in the treatment of epilepsy and bipolar disorder. A search of the literature did not find previously published bioequivalence and pharmacokinetic evaluations of lamotrigine in healthy Thai male volunteers. The aim of this study was to compare the pharmacokinetic parameters between 2 brands of lamotrigine in healthy Thai male volunteers. A randomized, single-dose, 2-period, 2-sequence, crossover study design with a 2-week washout period was conducted in healthy Thai males. Subjects were randomized to receive either the test or reference formulation in the first period. All subjects were required to be nonsmokers and without a history of alcohol or drug abuse. Plasma samples were collected over a 120-hour period after 100-mg lamotrigine administration in each period. A validated high-performance liquid chromatography ultraviolet method was used to analyze lamotrigine concentration in plasma. Pharmacokinetic parameters were determined using a noncompartmental method. Bioequivalence between the test and reference products, as defined by the US Food and Drug Administration (FDA), is determined when the ratio for the 90% CIs of the difference in the means of the log-transformed AUC(0-t), AUC(0-infinity), and C(max) of the 2 products are within 0.80 and 1.25. Adverse events were determined by measuring vital signs after dosing. Subjects were also asked if they suffered from undesirable effects such as nausea, vomiting, dizziness, and headache. This bioequivalence study was performed in 24 healthy Thai males (mean [SD] age, 20.5 [1.3] years; range, 19-24 years; weight, 62.5 [7.4] kg; height, 172.8 [6.9] cm; body mass index, 20.9 [2.0] kg/m(2)). The mean (SD) C(max) and T(max) of the test formulation of lamotrigine were 1.7 (0.3) microg/mL and 1.2 (0.9) hours, respectively. The mean (SD) C(max) and T(max) of the reference formulation of lamotrigine were 1.7 (0.3) microg/mL and 1.4 (1.0) hours, respectively. The mean

  12. Bioequivalence study of a new sildenafil 100 mg orodispersible film compared to the conventional film-coated 100 mg tablet administered to healthy male volunteers

    Science.gov (United States)

    Radicioni, Milko; Castiglioni, Chiara; Giori, Andrea; Cupone, Irma; Frangione, Valeria; Rovati, Stefano

    2017-01-01

    A new orodispersible film formulation of the phosphodiesterase type 5 inhibitor, sildenafil, has been developed to examine the advantages of an orally disintegrating film formulation and provide an alternative to the current marketed products for the treatment of erectile dysfunction. The pharmacokinetics of the sildenafil 100 mg orodispersible film (IBSA) was compared to that of the conventional marketed 100 mg film-coated tablet (Viagra®) after single-dose administration to 53 healthy male volunteers (aged 18–51 years) in a randomized, open, two-way crossover bioequivalence study. Each subject received a single oral dose of 100 mg of sildenafil as test or reference formulation administered under fasting conditions at each of the two study periods according to a randomized crossover design. There was a washout interval of ≥7 days between the two administrations of the investigational medicinal products. Blood samples for pharmacokinetic analysis were collected up to 24 h post-dosing. The primary objective was to compare the rate (peak plasma concentration; Cmax) and extent (area under the curve [AUC] from administration to last observed concentration time; AUC0–t) of sildenafil absorption after single-dose administration of test and reference. Secondary endpoints were observed to describe the plasma pharmacokinetic profiles of sildenafil and its metabolite N-desmethyl-sildenafil relative bioavailability and safety profile after single-dose administration. The mean sildenafil and N-desmethyl-sildenafil plasma concentration–time profiles up to 24 h after single-dose administration of sildenafil 100 mg orodispersible film and film-coated tablet were nearly superimposable. The bioequivalence test was fully satisfied for sildenafil and N-desmethyl-sildenafil in terms of rate and extent of bioavailability. Adverse events occurred at similar rates for the two formulations and were of mild-to-moderate severity. The results suggest that the new orodispersible film

  13. Development and validation of a liquid chromatography-tandem mass spectrometry method for topotecan determination in beagle dog plasma and its application in a bioequivalence study.

    Science.gov (United States)

    Ye, Ling; Shi, Jian; Wan, Shanhe; Yang, Xiaoshan; Wang, Ying; Zhang, Jiajie; Zheng, Dayong; Liu, Zhongqiu

    2013-11-01

    Topotecan (TPT) is an important anti-cancer drug that inhibits topoisomerase I. A sensitive and robust liquid chromatography-tandem mass spectrometry (LC-MS/MS) method that potentially determines TPT in beagle dog plasma is needed for a bioequivalence study of TPT formulations. We developed and validated LC-MS/MS to evaluate TPT in beagle dog plasma in terms of specificity, linearity, precision, accuracy, stability, extraction recovery and matrix effect. Plasma samples were treated with an Ostro(TM) sorbent plate (a robust and effective tool) to eliminate phospholipids and proteins before analysis. TPT and camptothecin (internal standard) were separated on an Acquity UPLC BEH C18 column (1.7 µm, 2.1 × 50 mm) with 0.1% formic acid and methanol as the mobile phase at a flow rate of 0.25 mL/min. TPT was analyzed using positive ion electrospray ionization in multiple-reaction monitoring mode. The obtained lower limit of quantitation was 1 ng/mL (signal-to-noise ratio > 10). The standard calibration curve for TPT was linear (correlation coefficient > 0.99) at the concentration range of 1-400 ng/mL. The intra-day and inter-day precision, accuracy, stability, extraction recovery and matrix effect of TPT were within the acceptable limits. The validated method was successfully applied in a bioequivalence study of TPT in healthy beagle dogs. Copyright © 2013 John Wiley & Sons, Ltd.

  14. Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLC–MS/MS and its application in bioequivalence studies

    Directory of Open Access Journals (Sweden)

    Bhupinder Singh

    2014-04-01

    Full Text Available A validated ultra-performance liquid chromatography mass spectrometric method (UPLC–MS/MS was used for the simultaneous quantitation of candesartan (CN and hydrochlorothiazide (HCT in human plasma. The analysis was performed on UPLC–MS/MS system using turbo ion spray interface. Negative ions were measured in multiple reaction monitoring (MRM mode. The analytes were extracted using a liquid–liquid extraction (LLE method by using 0.1 mL of plasma volume. The lower limit of quantitation for CN and HCT was 1.00 ng/mL whereas the upper limit of quantitation was 499.15 ng/mL and 601.61 ng/mL for CN and HCT respectively. CN d4 and HCT-13Cd2 were used as the internal standards for CN and HCT respectively. The chromatography was achieved within 2.0 min run time using a C18 Phenomenex, Gemini NX (100 mm×4.6 mm, 5 µm column with organic mixture:buffer solution (80:20, v/v at a flow rate of 0.800 mL/min. The method has been successfully applied to establish the bioequivalence of candesartan cilexetil (CNC and HCT immediate release tablets with reference product in human subjects. Keywords: Candesartan cilexetil, Hydrochlorothiazide, UPLC–MS/MS, Bioequivalence, Candesartan cilexetil-hydrochlorothiazide (ATACAND HCT

  15. Quantification of sibutramine and its two metabolites in human plasma by LC–ESI-MS/MS and its application in a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Venkata Suresh Ponnuru

    2012-08-01

    Full Text Available Obesity can be considered as a chronic illness of epidemic proportion and its incidents have increased exponentially in recent years. The use of anti-obesity drugs such as sibutramine is somewhat helpful. There is a need to quantify such drugs in biological samples, which is generally quite difficult. In this report, we developed and validated a simple, sensitive and specific liquid chromatography–tandem mass spectrometry (LC–MS/MS method for the quantification of sibutramine (SB and its two metabolites N-des methyl sibutramine (DSB and N-di desmethyl sibutramine (DDSB in human plasma. Zorbax SB-C18 (4.6 mm×75 mm, 3.5 μm, 80 Å analytical column and 5 mM ammonium formate:acetonitrile (10:90, v/v mobile phase were used for chromatographic separation of SB, DSB and DDSB. Multiple reaction monitoring (MRM in the positive mode was used to detect SB, DSB and DDSB at m/z 280.3/124.9, 266.3/125.3 and 252.2/124.9, respectively. Liquid–liquid extraction was used for the extraction of analytes and internal standard from human plasma. This method was validated over a linear concentration range of 10.0–10,000.0 pg/mL for SB, DSB and DDSB with correlation coefficients (r of ≥0.9997. The drug and the two metabolites were stable in plasma samples. The validated method was successfully applied in a bioequivalence and pharmacokinetic study with human volunteers under fasting condition. Keywords: LC–ESI-MS/MS, Sibutramine, Human plasma, Bioequivalence, Pharmacokinetic study

  16. Probabilistic approaches to recommendations

    CERN Document Server

    Barbieri, Nicola; Ritacco, Ettore

    2014-01-01

    The importance of accurate recommender systems has been widely recognized by academia and industry, and recommendation is rapidly becoming one of the most successful applications of data mining and machine learning. Understanding and predicting the choices and preferences of users is a challenging task: real-world scenarios involve users behaving in complex situations, where prior beliefs, specific tendencies, and reciprocal influences jointly contribute to determining the preferences of users toward huge amounts of information, services, and products. Probabilistic modeling represents a robus

  17. Child Care Provider Adherence to Infant and Toddler Feeding Recommendations: Findings from the Baby Nutrition and Physical Activity Self-Assessment for Child Care (Baby NAP SACC) Study

    Science.gov (United States)

    Davison, Kirsten K.; Hesketh, Kathryn; Taveras, Elsie M.; Gillman, Matthew W.; Benjamin Neelon, Sara E.

    2015-01-01

    Abstract Background: Identifying characteristics associated with the Institute of Medicine's (IOM) recommended feeding practices among infant and toddler care providers in child care centers could help in preventing childhood obesity. Methods: In 2009, at baseline in a pilot intervention study of 29 licensed Massachusetts child care centers with at least 50% of enrolled children identified as racial minorities, 57 infant and 109 toddler providers completed feeding questionnaires. To assess provider adherence to six IOM-recommended behaviors, we used cluster-adjusted multivariable logistic regression models including provider type (infant or toddler), race, education, and center Child and Adult Care Food Program (CACFP) participation. Results: In multivariable analysis, CACFP participation was associated with providers sitting with children at meals (odds ratio [OR], 5.2; 95% confidence interval [CI], 1.2–21.7), offering fruits and vegetables (OR, 3.3; 95% CI 1.7–6.2), and limiting fast food (OR, 3.5; 95% CI, 1.8–6.7). Providers at centers serving meals family style were less likely to allow children to leave food unfinished (OR, 0.27; 95% CI, 0.09–0.77). Infant providers were more likely than toddler providers to sit with children at meals (OR, 6.98; 95% CI, 1.51–32.09), allow children to eat when hungry (OR, 3.50; 95% CI, 1.34–9.16), and avoid serving sugary (OR, 8.74; 95% CI, 3.05–25.06) or fast foods (OR, 11.56; 95% CI, 3.20–41.80). Conclusions: CACFP participation may encourage IOM-recommended feeding practices among infant and toddler providers. Child care providers may benefit from education about how to feed infants and toddlers responsively, especially when offering foods family style. Future research should explore ways to promote child-centered feeding practices, while addressing barriers to providing children with nutrient-rich foods. PMID:25918873

  18. A Hybrid Recommender System Based on User-Recommender Interaction

    OpenAIRE

    Zhang, Heng-Ru; Min, Fan; He, Xu; Xu, Yuan-Yuan

    2015-01-01

    Recommender systems are used to make recommendations about products, information, or services for users. Most existing recommender systems implicitly assume one particular type of user behavior. However, they seldom consider user-recommender interactive scenarios in real-world environments. In this paper, we propose a hybrid recommender system based on user-recommender interaction and evaluate its performance with recall and diversity metrics. First, we define the user-recommender interaction...

  19. An Analysis of Alternatives for Reducing Outpatient Military Health Care Costs for Active Duty Members and their Families: Implementing a Recommended Savings Strategy Using Defense Acquisition Principles

    National Research Council Canada - National Science Library

    Jaime, Richardo; Rupert, Joshua W

    2007-01-01

    .... In efforts to reduce or contain the costs of the military health care system, this project will propose two cost savings alternatives for providing outpatient care to active duty personnel and their dependents...

  20. Summary (and) recommendations

    International Nuclear Information System (INIS)

    1992-01-01

    This report looks at the Health and Safety record at the Atomic Weapons Establishment at Aldermaston. The last outside report was by Pochin in 1978 which recommended that staffing for health physicists and maintenance staff should be increased and that some buildings where solid and liquid radioactive wastes were processed should be replaced. A new facility to process contaminated heavy equipment was also recommended. This report finds that none of the recommendations have been fully implemented. It also lists accidents, fires and worker contamination. It is concluded that some of the problems are that nuclear weapons production is inherently unsafe and cannot be made safe, that the secrecy surrounding the establishments' safety record is not good for improving it and finally the report calls for production at Aldermaston to be halted. (UK)

  1. Archetypal Game Recommender Systems

    DEFF Research Database (Denmark)

    Sifa, Rafet; Bauckhage, C.; Drachen, Anders

    2014-01-01

    Contemporary users (players, consumers) of digital games have thousands of products to choose from, which makes nding games that t their interests challenging. Towards addressing this challenge, in this paper two dierent formulations of Archetypal Analysis for Top-L recommender tasks using implicit...... feedback are presented: factor- and neighborhood-oriented models. These form the rst application of rec- ommender systems to digital games. Both models are tested on a dataset of 500,000 users of the game distribution platform Steam, covering game ownership and playtime data across more than 3000 games....... Compared to four other recommender models (nearest neighbor, two popularity mod- els, random baseline), the archetype based models provide the highest recall rates showing that Archetypal Analysis can be successfully applied for Top-L recommendation purposes...

  2. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...... the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers...... internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations...

  3. Recommending Multidimensional Queries

    Science.gov (United States)

    Giacometti, Arnaud; Marcel, Patrick; Negre, Elsa

    Interactive analysis of datacube, in which a user navigates a cube by launching a sequence of queries is often tedious since the user may have no idea of what the forthcoming query should be in his current analysis. To better support this process we propose in this paper to apply a Collaborative Work approach that leverages former explorations of the cube to recommend OLAP queries. The system that we have developed adapts Approximate String Matching, a technique popular in Information Retrieval, to match the current analysis with the former explorations and help suggesting a query to the user. Our approach has been implemented with the open source Mondrian OLAP server to recommend MDX queries and we have carried out some preliminary experiments that show its efficiency for generating effective query recommendations.

  4. Helping Clinicians Prevent Pregnancy among Sexually Active Adolescents: U.S. Medical Eligibility Criteria for Contraceptive Use and U.S. Selected Practice Recommendations for Contraceptive Use.

    Science.gov (United States)

    Godfrey, Emily M

    2015-08-01

    The United States has made substantial progress in reducing teenage birth rates in recent decades, but rates remain high. Teen pregnancy can increase the risk of poor health outcomes and lead to decreased educational attainment, increased poverty, and welfare use, as well as increased cost to taxpayers. One of the most effective ways to prevent teenage pregnancy is through the use of effective birth control methods. The Centers for Disease Control (CDC) and Prevention has made the prevention of teenage pregnancy 1 of its 10 winnable battles. The CDC has released 2 evidence-based clinical guideline documents regarding contraceptive use for adolescents and adults. The first guideline, US Medical Eligibility Criteria for Contraceptive Use, 2010, helps clinicians recognize when a contraceptive method may not be safe to use for a particular adolescent but also when not to withhold a contraceptive method that is safe to use. The second document, US Selected Practice Recommendations for Contraceptive Use, 2013, provides guidance for how to use contraceptive methods safely and effectively once they are deemed safe. Health care providers are encouraged to use these documents to provide safe and effective contraceptive care to patients seeking family planning, including adolescents. Copyright © 2015 North American Society for Pediatric and Adolescent Gynecology. All rights reserved.

  5. How to Apply the User Profile Usability Technique in the User Modelling Activity for an Adaptive Food Recommendation System for People on Special Diets

    Directory of Open Access Journals (Sweden)

    Lucrecia Llerena

    2017-10-01

    Full Text Available Interest among software professionals in the possibility of adapting software to user requirements has grown as a result of the evolution of software analysis, design and implementation thinking and the growth in the number of software systems users. Moving away from the traditional approach where the user has to settle for the options offered by software systems, different factors (e.g. user needs, aspirations, preferences, knowledge level, goals have to be taken into account for this purpose. Technically, this possibility is referred to as adaptiveness, and it requires user data. It is these data (user model that determine the adaptiveness conditions. Our aim is to build a user model for adaptive systems applied to nutritional requirements, modelling user characteristics that affect their diets and help to improve their health. To build the user model, we apply the user profile usability technique. In order to validate our proposal, we analyse and design a preliminary prototype of an adaptive system capable of making food recommendations to satisfy specific user needs. This study revealed that diet is a propitious field for the development of adaptive systems and that user modelling is a good choice for design of this type of systems.

  6. New Insulin Delivery Recommendations.

    Science.gov (United States)

    Frid, Anders H; Kreugel, Gillian; Grassi, Giorgio; Halimi, Serge; Hicks, Debbie; Hirsch, Laurence J; Smith, Mike J; Wellhoener, Regine; Bode, Bruce W; Hirsch, Irl B; Kalra, Sanjay; Ji, Linong; Strauss, Kenneth W

    2016-09-01

    Many primary care professionals manage injection or infusion therapies in patients with diabetes. Few published guidelines have been available to help such professionals and their patients manage these therapies. Herein, we present new, practical, and comprehensive recommendations for diabetes injections and infusions. These recommendations were informed by a large international survey of current practice and were written and vetted by 183 diabetes experts from 54 countries at the Forum for Injection Technique and Therapy: Expert Recommendations (FITTER) workshop held in Rome, Italy, in 2015. Recommendations are organized around the themes of anatomy, physiology, pathology, psychology, and technology. Key among the recommendations are that the shortest needles (currently the 4-mm pen and 6-mm syringe needles) are safe, effective, and less painful and should be the first-line choice in all patient categories; intramuscular injections should be avoided, especially with long-acting insulins, because severe hypoglycemia may result; lipohypertrophy is a frequent complication of therapy that distorts insulin absorption, and, therefore, injections and infusions should not be given into these lesions and correct site rotation will help prevent them; effective long-term therapy with insulin is critically dependent on addressing psychological hurdles upstream, even before insulin has been started; inappropriate disposal of used sharps poses a risk of infection with blood-borne pathogens; and mitigation is possible with proper training, effective disposal strategies, and the use of safety devices. Adherence to these new recommendations should lead to more effective therapies, improved outcomes, and lower costs for patients with diabetes. Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  7. Review of ICRP recommendations

    International Nuclear Information System (INIS)

    Goldfinch, E.P.

    1987-01-01

    Events in both the scientific world and in the public domain have added pressure to review the recommendations of the ICRP on which radiation protection legislation in most countries is founded. A brief editorial pleads for clarity in ICRP recommendations, suggests the use solely of cumulative with age individual occupational dose limits, suggests that collective doses including both occupational and to the public should be kept as low as reasonably achievable, judged on quantitative economic grounds, and suggests the setting of a probability for serious accidents which may be disregarded in planning. (UK)

  8. RECOMMENDATIONS FOR ACHIEVING MEDIUM- AND HIGH-INTENSITY PHYSICAL / SPORT ACTIVITY IN PHYSICAL EDUCATION TO IMPROVE THE HEALTH AND LEARNING OF CHILDREN AND ADOLESCENTS

    Directory of Open Access Journals (Sweden)

    Bostjan Šimunič

    2016-01-01

    Full Text Available The world faces an epidemic of general physical inactivity, impeding the achievement of a sufficient level of medium- and high-intensity physical / sport activities (P / SA. Never in human history were people less physically active than they are now, both at work and in their free time. The most problematic seem to be children and adolescents whose level of P / SA decreases and is not sufficient for maintaining health. School plays an important role in ensuring sufficient and quality P / SA. Physical education is a key period during school when students can be physically active. Consequently, policy makers and moderators of strategies in the field of movement, health and sport should strive to develop the appropriate curriculum and strategies for increasing the volume, intensity and quality of P / SA during physical education. Teachers should pay particular attention, with didactic and methodical approaches, to the achievement of medium- and high-intensity of children’s P / SA.

  9. Investigation of bioequivalence of a new fixed-dose combination of nifedipine and candesartan with the corresponding loose combination as well as the drug-drug interaction potential between both drugs under fasting conditions.

    Science.gov (United States)

    Brendel, Erich; Weimann, Boris; Dietrich, Hartmut; Froede, Christoph; Thomas, Dirk

    2013-09-01

    To determine the bioequivalence of a nifedipine and candesartan fixed-dose combination (FDC) with the corresponding loose combination, and to investigate the pharmacokinetic drug-drug interaction potential between both drugs. 49 healthy, white, male subjects received: 60 mg nifedipine and 32 mg candesartan FDC, the loose combination of 60 mg nifedipine GITS and 32 mg candesartan, 60 mg nifedipine GITS alone, or 32 mg candesartan alone in a randomized, non-blinded, 4-period, 4-way crossover design with each dosing following overnight fasting. Treatment periods were separated by washout periods of ≥ 5 days. Plasma samples were collected for 48 hours after dosing and assayed using a validated LC-MS/MS method. Bioequivalence between the FDC and the loose combination as well as the impact of combined treatment with both drugs on candesartan pharmacokinetics was evaluated in 47 subjects, while the corresponding impact of treatment with both drugs on nifedipine pharmacokinetics was assessed in 46 patients. For AUC(0-tlast) and Cmax the 90% confidence intervals (CIs) for the ratios of the FDC vs. the corresponding loose combination were within the acceptance range for bioequivalence of 80 - 125%. When comparing AUC(0-tlast) and Cmax of nifedipine and candesartan after dosing with the loose combination vs. each drug alone, the 90% CIs remained within the range of 80 - 125% indicating the absence of a clinically relevant pharmacokinetic drug-drug interaction. Nifedipine and candesartan as well as the combinations were well tolerated. The FDC containing 60 mg nifedipine and 32 mg candesartan was bioequivalent to the corresponding loose combination following single oral doses under fasting conditions. No clinically relevant pharmacokinetic drug-drug interaction between nifedipine and candesartan was observed.

  10. Scientific Perspectives on Extending the Provision for Waivers of In vivo Bioavailability and Bioequivalence Studies for Drug Products Containing High Solubility-Low Permeability Drugs (BCS-Class 3)

    OpenAIRE

    Stavchansky, Salomon

    2008-01-01

    Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA–BE) studies that appeared in the guidance published by the Food and Drug Administration (FDA) (1) to pharmaceutical products containing Class 3 drugs (High solubility–Low Permeability). The extension of the Biopharmaceutics Classification System (BCS) to Class 3 drugs is meritorious because of its impact on public health policy considerations. The rate limiting ...

  11. Privacy enhanced recommender system

    NARCIS (Netherlands)

    Erkin, Zekeriya; Erkin, Zekeriya; Beye, Michael; Veugen, Thijs; Lagendijk, Reginald L.

    2010-01-01

    Recommender systems are widely used in online applications since they enable personalized service to the users. The underlying collaborative filtering techniques work on user’s data which are mostly privacy sensitive and can be misused by the service provider. To protect the privacy of the users, we

  12. Recommendations for Alternative Credit.

    Science.gov (United States)

    Lenderman, Ed; And Others

    Following a review of the mathematics topics taught in accounting, electronics, auto, food and clothing, and metals courses at Linn-Benton Community College, Albany, Oregon, recommendations were made to grant one semester of mathematics credit for completing a two-year sequence of these courses. The other required semester of mathematics should be…

  13. Towards Geosocial Recommender Systems

    NARCIS (Netherlands)

    de Graaff, V.; van Keulen, Maurice; de By, R.A.; de By, Rolf A.

    2012-01-01

    The usage of social networks sites (SNSs), such as Facebook, and geosocial networks (GSNs), such as Foursquare, has increased tremendously over the past years. The willingness of users to share their current locations and experiences facilitate the creation of geographical recommender systems based

  14. Search and Recommendation

    DEFF Research Database (Denmark)

    Bogers, Toine

    2014-01-01

    In just a little over half a century, the field of information retrieval has experienced spectacular growth and success, with IR applications such as search engines becoming a billion-dollar industry in the past decades. Recommender systems have seen an even more meteoric rise to success with wide...

  15. Chapter 10: Management recommendations

    Science.gov (United States)

    Deborah M. Finch; Janie Agyagos; Tracy McCarthey; Robert M. Marshall; Scott H. Stoleson; Mary J. Whitfield

    2000-01-01

    This chapter was developed over a series of meetings using a group-consensus process. Our recommendations are based on published results, on information compiled in the previous chapters, on expert opinion, and on unpublished data of conservation team members. This chapter is available as temporary guidance until the Recovery Plan for the southwestern willow flycatcher...

  16. Privacy in Recommender Systems

    NARCIS (Netherlands)

    Jeckmans, Arjan; Beye, Michael; Erkin, Zekeriya; Erkin, Zekeriya; Hartel, Pieter H.; Lagendijk, Reginald; Tang, Qiang; Ramzan, Naeem; van Zwol, Roelof; Lee, Jong-Seok; Clüver, Kai; Hua, Xian-Sheng

    In many online applications, the range of content that is offered to users is so wide that a need for automated recommender systems arises. Such systems can provide a personalized selection of relevant items to users. In practice, this can help people find entertaining movies, boost sales through

  17. School Health Guidelines to Promote Healthy Eating and Physical Activity. Morbidity and Mortality Weekly Report. Recommendations and Reports. Volume 60, Number 5

    Science.gov (United States)

    Rutledge, Teresa F., Ed.

    2011-01-01

    During the last 3 decades, the prevalence of obesity has tripled among persons aged 6-19 years. Multiple chronic disease risk factors, such as high blood pressure, high cholesterol levels, and high blood glucose levels are related to obesity. Schools have a responsibility to help prevent obesity and promote physical activity and healthy eating…

  18. Special report : Workshop on 4D-treatment planning in actively scanned particle therapy-Recommendations, technical challenges, and future research directions

    NARCIS (Netherlands)

    Knopf, Antje; Bert, Christoph; Heath, Emily; Nill, Simeon; Kraus, Kim; Richter, Daniel; Hug, Eugen B.; Pedroni, Eros; Safai, Sairos; Albertini, Francesca; Zenklusen, Silvan; Boye, Dirk; Söhn, Matthias; Soukup, Martin; Sobotta, Benjamin; Lomax, Antony

    This article reports on a 4D-treatment planning workshop (4DTPW), held on 7-8 December 2009 at the Paul Scherrer Institut (PSI) in Villigen, Switzerland. The participants were all members of institutions actively involved in particle therapy delivery and research. The purpose of the 4DTPW was to

  19. The ICRP 2007 recommendations

    International Nuclear Information System (INIS)

    Streffer, C.

    2007-01-01

    The last comprehensive International Commission on Radiological Protection (ICRP) recommendations have been published in 1991(1). Since that time new data in physics and biology that are relevant for radiological protection have appeared in the scientific literature. Also, the general thinking about safety standards at the workplace as well as for the protection of the public has developed. Thus, a review of the recommendations is needed. However, as the present standards have worked well, these new recommendations should build on the present ones. Only a process of further development should take place allowing for the following key points: - new biological and physical information and trends in the setting of safety standards; - improvement in the presentation of the recommendations; as much stability in the recommendations as is consistent with the new information and environmental aspects will be included. The fundamental principles of radiological protection will remain the same as they have been described in ICRP publication 60(1): Justification: Actions involving new exposures or changes in exposures of individuals have to be justified in advance. A positive net benefit must result. Optimisation: Exposures should be as low as reasonably achievable and should be optimised in relation to with dose constraints. Dose limits: The values will not to be changed from Publication 60. Dose constraints: Development of the concept proposed in Publication 60 will be explained. The ICRP Committees have prepared foundation documents in the fields for which they are responsible and their members have the corresponding expertise. These foundation documents will support the decisions and explain the various statements of the Main Commission in a broader sense. Some of them will be published as Annexes to the recommendations (Annex A: Biological and Epidemiological Information on Health Risks Attributable to Ionising Radiation; Annex B: Quantities used in Radiological

  20. The ICRP 2007 recommendations

    Energy Technology Data Exchange (ETDEWEB)

    Streffer, C. [Chairman of ICRP Committee 2, Institute of Science and Ethics, University Duisburg-Essen, 45117 Essen (Germany)

    2007-07-01

    The last comprehensive International Commission on Radiological Protection (ICRP) recommendations have been published in 1991(1). Since that time new data in physics and biology that are relevant for radiological protection have appeared in the scientific literature. Also, the general thinking about safety standards at the workplace as well as for the protection of the public has developed. Thus, a review of the recommendations is needed. However, as the present standards have worked well, these new recommendations should build on the present ones. Only a process of further development should take place allowing for the following key points: - new biological and physical information and trends in the setting of safety standards; - improvement in the presentation of the recommendations; as much stability in the recommendations as is consistent with the new information and environmental aspects will be included. The fundamental principles of radiological protection will remain the same as they have been described in ICRP publication 60(1): Justification: Actions involving new exposures or changes in exposures of individuals have to be justified in advance. A positive net benefit must result. Optimisation: Exposures should be as low as reasonably achievable and should be optimised in relation to with dose constraints. Dose limits: The values will not to be changed from Publication 60. Dose constraints: Development of the concept proposed in Publication 60 will be explained. The ICRP Committees have prepared foundation documents in the fields for which they are responsible and their members have the corresponding expertise. These foundation documents will support the decisions and explain the various statements of the Main Commission in a broader sense. Some of them will be published as Annexes to the recommendations (Annex A: Biological and Epidemiological Information on Health Risks Attributable to Ionising Radiation; Annex B: Quantities used in Radiological

  1. Australians are not Meeting the Recommended Intakes for Omega-3 Long Chain Polyunsaturated Fatty Acids: Results of an Analysis from the 2011–2012 National Nutrition and Physical Activity Survey

    Directory of Open Access Journals (Sweden)

    Barbara J. Meyer

    2016-02-01

    Full Text Available Health benefits have been attributed to omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA. Therefore it is important to know if Australians are currently meeting the recommended intake for n-3 LCPUFA and if they have increased since the last National Nutrition Survey in 1995 (NNS 1995. Dietary intake data was obtained from the recent 2011–2012 National Nutrition and Physical Activity Survey (2011–2012 NNPAS. Linoleic acid (LA intakes have decreased whilst alpha-linolenic acid (LNA and n-3 LCPUFA intakes have increased primarily due to n-3 LCPUFA supplements. The median n-3 LCPUFA intakes are less than 50% of the mean n-3 LCPUFA intakes which highlights the highly-skewed n-3 LCPUFA intakes, which shows that there are some people consuming high amounts of n-3 LCPUFA, but the vast majority of the population are consuming much lower amounts. Only 20% of the population meets the recommended n-3 LCPUFA intakes and only 10% of women of childbearing age meet the recommended docosahexaenoic acid (DHA intake. Fish and seafood is by far the richest source of n-3 LCPUFA including DHA.

  2. Recommendations for the management of individuals with acquired valvular heart diseases who are involved in leisure-time physical activities or competitive sports.

    Science.gov (United States)

    Mellwig, Klaus Peter; van Buuren, Frank; Gohlke-Baerwolf, Christa; Bjørnstad, Hans Halvor

    2008-02-01

    Physical check-ups among athletes with valvular heart disease are of significant relevance. In athletes with mitral valve stenosis the extent of allowed physical activity is dependant on the size of the left atrium and the severity of the valve defect. Patients with mild-to-moderate mitral valve regurgitation can participate in all types of sport associated with low and moderate isometric stress and moderate dynamic stress. Patients under anticoagulation should not participate in any type of contact sport. Asymptomatic athletes with mild aortic valve stenosis can take part in all types of sport, as long as left ventricular function and size are normal, a normal response to exercise at the level performed during athletic activities is present and there are no arrhythmias. Asymptomatic athletes with moderate aortic valve stenosis should only take part in sports with low dynamic and static stress. Aortic valve regurgitation is often present due to connective tissue disease of a bicuspid valve. Athletes with mild aortic valve regurgitation, with normal end diastolic left ventricular size and systolic function can participate in all types of sport. A mitral valve prolapse is often associated with structural diseases of the myocardium and endocardium. In patients with mitral valve prolapse Holter-ECG monitoring should also be performed to detect significant arrhythmias. All athletes with known valvular heart disease, a previous history of infective endocarditis and valve surgery should receive endocarditis prophylaxis before dental, oral, respiratory, intestinal and genitourinary procedures associated with bacteraemia. Sport activities have to be avoided during active infection with fever.

  3. weHelp: A Reference Architecture for Social Recommender Systems.

    Science.gov (United States)

    Sheth, Swapneel; Arora, Nipun; Murphy, Christian; Kaiser, Gail

    2010-01-01

    Recommender systems have become increasingly popular. Most of the research on recommender systems has focused on recommendation algorithms. There has been relatively little research, however, in the area of generalized system architectures for recommendation systems. In this paper, we introduce weHelp : a reference architecture for social recommender systems - systems where recommendations are derived automatically from the aggregate of logged activities conducted by the system's users. Our architecture is designed to be application and domain agnostic. We feel that a good reference architecture will make designing a recommendation system easier; in particular, weHelp aims to provide a practical design template to help developers design their own well-modularized systems.

  4. Estudio de bioequivalencia de clonazepam, tabletas de 2 mg, en voluntarios sanos colombianos Bioequivalence study of clonazepam 2 mg tablets in colombian healthy volunteers

    Directory of Open Access Journals (Sweden)

    Victoria Eugenia Toro Pareja

    2007-08-01

    Full Text Available Con el fin de determinar la bioequivalencia de dos formulaciones de tabletas de 2 mg de clonazepam: Sedatril®/Clonazepam MK (Tecnoquímicas S. A., Cali, Colombia como producto de prueba y Rivotril® (Roche Químicos e Farmacéuticas S. A., Río de Janeiro, Brasil, como producto de referencia, se realizó un estudio de bioequivalencia en 26 voluntarios sanos. Los productos de prueba y de referencia se administraron en condiciones de ayuno de acuerdo con un diseño cruzado aleatorio de dosis única, con dos secuencias, dos tratamientos y un período de lavado de 28 días. Las muestras de sangre se obtuvieron desde las 0 hasta las 96 horas después de la administración del medicamento. Los niveles plasmáticos de clonazepam se determinaron con un método validado por cromatografía líquida de alta eficiencia con detección ultravioleta (HPLC/UV, siglas en inglés. Los parámetros farmacocinéticos ABC0-96, ABC0-∞, Cmax, Tmax, t1/2, and ke se determinaron de los perfiles plasmáticos concentración-tiempo por el método no compartimental. El test de bioequivalencia se realizó con los datos transformados a logaritmo natural (ln de ABC0-∞and Cmax. Los intervalos de confianza del 90% para la relación producto de prueba/producto de referencia fueron de 87,9% a 103,6% y 84,4% a 104,0%, respectivamente. Estos resultados estuvieron dentro de los rangos de aceptación del 80,0% al 125%, establecidos por la FDA y se concluyó que ambos productos son bioequivalentes. In order to determine the bioequivalence of two formulations of clonazepam 2 mg tablets: Sedatril®/ Clonazepam MK (Tecnoquímicas S. A., Cali, Colombia as a test product and Rivotril® (Roche Químicos e Farmacêuticas S. A., Rio de Janeiro, Brazil as a reference product, a bioavailability study was performed in 26 healthy volunteers. Test and reference products were administered under fasting conditions following a single dose, two-sequences, two treatments, crossover randomized

  5. ICRS Recommendation Document

    DEFF Research Database (Denmark)

    Roos, Ewa M.; Engelhart, Luella; Ranstam, Jonas

    2011-01-01

    and function evaluated for validity and psychometric properties in patients with articular cartilage lesions. Results: The knee-specific instruments, titled the International Knee Documentation Committee Subjective Knee Form and the Knee injury and Osteoarthritis and Outcome Score, both fulfill the basic......Abstract Objective: The purpose of this article is to describe and recommend patient-reported outcome instruments for use in patients with articular cartilage lesions undergoing cartilage repair interventions. Methods: Nonsystematic literature search identifying measures addressing pain...... constructs at all levels according to the International Classification of Functioning. Conclusions: Because there is no obvious superiority of either instrument at this time, both outcome measures are recommended for use in cartilage repair. Rescaling of the Lysholm Scoring Scale has been suggested...

  6. Badali recommends simplified bills

    International Nuclear Information System (INIS)

    Anon

    2003-01-01

    A report on the variety of retail electricity bills across the province, authored by Salvatore Badali of Deloitte Consulting, was recently released by the Ontario Government. The report was commissioned by the Government to examine the underlying reasons for the significant format differences and the wide variation of fixed and variable charges among the approximately 95 local electricity distribution companies across the province. Regarding the appropriateness of the charges the report recommends common definitions for local distribution company (LDC) fixed and variable costs, and consideration of options for reducing LDC charges, mainly by consolidating the sector and sharing such services as customer billing, accounting and out sourcing operations. Seven recommendations deal with bill simplification. These include bills that are clear and easy to read and provide sufficient information for consumers to verify charges; promote energy conservation, e.g. by including historical information; allow comparisons between retail suppliers and distributors; accommodate revenue collection, marketing needs and other billing services. The report also recommends clearly defined and consistently used terminology for standardized line items, suggests ways to provide consumer information in a form useful for making energy conservation decisions, development of an LDC scorecard to enable stake holders to compare their own LDCs with LDCs around the province, creation of a conservation and bill calculation website, consideration of further use of shared services, and solutions to address the removal of line losses from invoices

  7. Badali recommends simplified bills

    Energy Technology Data Exchange (ETDEWEB)

    Anon

    2003-04-01

    A report on the variety of retail electricity bills across the province, authored by Salvatore Badali of Deloitte Consulting, was recently released by the Ontario Government. The report was commissioned by the Government to examine the underlying reasons for the significant format differences and the wide variation of fixed and variable charges among the approximately 95 local electricity distribution companies across the province. Regarding the appropriateness of the charges the report recommends common definitions for local distribution company (LDC) fixed and variable costs, and consideration of options for reducing LDC charges, mainly by consolidating the sector and sharing such services as customer billing, accounting and out sourcing operations. Seven recommendations deal with bill simplification. These include bills that are clear and easy to read and provide sufficient information for consumers to verify charges; promote energy conservation, e.g. by including historical information; allow comparisons between retail suppliers and distributors; accommodate revenue collection, marketing needs and other billing services. The report also recommends clearly defined and consistently used terminology for standardized line items, suggests ways to provide consumer information in a form useful for making energy conservation decisions, development of an LDC scorecard to enable stake holders to compare their own LDCs with LDCs around the province, creation of a conservation and bill calculation website, consideration of further use of shared services, and solutions to address the removal of line losses from invoices.

  8. Zero emission to sea from the petroleum activities: Status and recommendations 2003; Nullutslipp til sjoe fra petroleumsvirksomheten: status og anbefalinger 2003

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-07-01

    By 2005, emission of oil and environmentally harmful substances from the oil and gas activities on the Norwegian Shelf shall be reduced. National State Pollution Control Authority (SFT), The Norwegian Petroleum Directorate (NPD) and The Norwegian Oil Industry Association (OLF) have agreed upon the goal and progress in the zero emission work. An advisory committee including representatives from SFT, NPD and OLF, the so-called zero emission group, has worked on concretizing the zero emission goal for 2005. This report presents the committee's conclusions and plans, which are in line with the recent amplification by the government regarding the zero emission target. This target is immediately valid for new developments and is to be achieved by 2005 for existing fields.

  9. Mobile Application Recommender System

    OpenAIRE

    Davidsson, Christoffer

    2010-01-01

    With the amount of mobile applications available increasing rapidly, users have to put a lot of effort into finding applications of interest. The purpose of this thesis is to investigate how to aid users in the process of discovering new mobile applications by providing them with recommendations. A prototype system is then built as a proof-of-concept. The work of the thesis is divided into three phases where the aim of the first phase is to study related work and related systems to identify p...

  10. Clinical Recommendation: Vulvovaginitis.

    Science.gov (United States)

    Zuckerman, Andrea; Romano, Mary

    2016-12-01

    Vulvovaginitis is a commonly encountered condition among prepubertal and adolescent females. The objective of this report is to provide the latest evidence regarding the diagnosis and management of vulvovaginitis in prepubertal and adolescent females. In this systematic review we used the Grading of Recommendations Assessment, Development and Evaluation evidence system. Vulvovaginal complaints are common in the pediatric and adolescent age group. The patient's age in conjunction with history and associated complaints will guide evaluation, diagnosis, and treatment. Treatment should include counseling on hygiene and voiding techniques as well as therapy for any specific pathogens identified. Copyright © 2016.

  11. The new ICRP recommendations

    International Nuclear Information System (INIS)

    Schlesinger, T.

    1977-01-01

    The new ICRP recommendations are based on the concept of risk. The doses received by workers have to be justified and kept as low as practically achievable. The acceptable annual occupational risk is of the order of 10 -4 . This corresponds to an average annual dose equivalent of about 5 mSv(0.5 Rem). The annual dose equivalent limit for whole body irradiation will remain 50 mSv/year (5 Rem/year) provided that the average is about 1/10th of this value. The concept of the critical organ is abandoned and is replaced by the concept of equidetriment. (author)

  12. Personalized professional content recommendation

    Science.gov (United States)

    Xu, Songhua

    2015-10-27

    A personalized content recommendation system includes a client interface configured to automatically monitor a user's information data stream transmitted on the Internet. A hybrid contextual behavioral and collaborative personal interest inference engine resident to a non-transient media generates automatic predictions about the interests of individual users of the system. A database server retains the user's personal interest profile based on a plurality of monitored information. The system also includes a server programmed to filter items in an incoming information stream with the personal interest profile and is further programmed to identify only those items of the incoming information stream that substantially match the personal interest profile.

  13. Recommendation-Aware Smartphone Sensing System

    OpenAIRE

    Chen, Mu-Yen; Wu, Ming-Ni; Chen, Chia-Chen; Chen, Young-Long; Lin, Hsien-En

    2014-01-01

    The context-aware concept is to reduce the gap between users and information systems so that the information systems actively get to understand users’ context and demand and in return provide users with better experience. This study integrates the concept of context-aware with association algorithms to establish the context-aware recommendation systems (CARS). The CARS contains three modules and provides the product recommendations for users with their smartphone. First, the simple RSSI Indoo...

  14. Recommender Systems in Commercial Use

    OpenAIRE

    Aldrich, Susan E.

    2011-01-01

    Commercial recommender systems are deployed by marketing teams to increase revenue and/or personalize user experience. Marketers evaluate recommender systems not on its algorithms but on how well the vendor‘s expertise and interfaces will support achieving business goals. Driven by a business model that pays based on recommendation success, vendors guide clients through continuous optimization of recommendations. While recommender technology is mature, the solutions and market are still young...

  15. Quantification of amlodipine and atorvastatin in human plasma by UPLC-MS/MS method and its application to a bioequivalence study.

    Science.gov (United States)

    Rezk, Mamdouh R; Badr, Kamal A

    2018-07-01

    A robust, rapid and sensitive UPLC-MS/MS method has been developed, optimized and validated for the determination of amlodipine (AML) and atorvastatin (ATO) in human plasma using eplerenone as an internal standard (IS). Multiple-reaction monitoring in positive electrospray ionization mode was utilized in Xevo TQD LC-MS/MS. Double extraction was used in sample preparation using diethyl ether and ethyl acetate. The prepared samples were analyzed using an Acquity UPLC BEH C 18 (50 × 2.1 mm, 1.7 μm) column. Ammonium formate and acetonitrile, pumped isocraticaly at a flow rate of 0.25 mL/min, were used as a mobile phase. Method validation was done as per the US Food and Drug Administration guidelines. Linearity was achieved in the range of 0.1-10 ng/mL for AML and 0.05-50 ng/mL for ATO. Intra-day and inter-day accuracy and precision were calculated and found to be within the acceptable range. A short run time, of <1.5 min, permits analysis of a large number of plasma samples per batch. The developed and validated method was applied to estimate AML and ATO in a bioequivalence study in healthy human volunteers. Copyright © 2018 John Wiley & Sons, Ltd.

  16. Liquid chromatography-tandem mass spectrometry for the quantification of flurbiprofen in human plasma and its application in a study of bioequivalence.

    Science.gov (United States)

    Mei, Chenghan; Li, Bin; Yin, Qiangfeng; Jin, Jing; Xiong, Ting; He, Wenjuan; Gao, Xiujuan; Xu, Rong; Zhou, Piqi; Zheng, Heng; Chen, Hui

    2015-07-01

    A simple, quick and accurate LC-MS/MS method for the quantification of flurbiprofen in human plasma with indomethacin as internal standard (IS) was developed and validated. Samples were treated with methanol to precipitate proteins, then separated on a Ultimate C18 column (5μm, 2.1×50mm) with a gradient elusion process. Mobile phase A was comprised of water and formic acid, mobile phase B was comprised of acetonitrile and formic acid. Multi reaction monitoring (MRM) signals were saved on a negative ionization electrospray mass spectrometer. The calibration curve showed good linearity in the range of 40.00-10000.00μg/L (r(2)=0.998). Intra-day RE was 0.2-2.2%. Inter-day RE was 0.5-3.4%. The samples showed good stability under the study conditions. No significant matrix effect was observed. The established method was then applied to a bioequivalence study of a flurbiprofen axetil formulation. Copyright © 2015 Elsevier B.V. All rights reserved.

  17. Development and validation of an improved method for the quantitation of sertraline in human plasma using LC-MS-MS and its application to bioequivalence studies.

    Science.gov (United States)

    Zhang, Mengliang; Gao, Feng; Cui, Xiangyong; Zhang, Yunhui; Sun, Yantong; Gu, Jingkai

    2011-02-01

    A rapid and sensitive LC-MS-MS method for the quantitation of sertraline in human plasma was developed and validated. Sertraline and the internal standard, telmisartan, were cleaned up by protein precipitation from 100 μL of plasma sample, and analyzed on a TC-C18 column (5 μm, 150 × 4.6 mm i.d.) using 70% acetonitrile and 30% 10 mM ammonium acetate (0.1% formic acid) as mobile phase. The method was demonstrated to be linear from 0.1 ng/mL to 50 ng/mL with the lower limit of quantitation of 0.1 ng/mL. Intra- and inter-day precision were below 4.40% and 3.55%. Recoveries of sertraline at low, medium, and high levels were 88.0 ± 2.3%, 88.2 ± 1.9%, and 90.0 ± 2.0%, respectively. The method was successfully applied to a bioequivalence study of sertraline after a single oral administration of 50 mg sertraline hydrochloride tablets.

  18. Use of an in vitro human skin permeation assay to assess bioequivalence of two topical cream formulations containing butenafine hydrochloride (1%, w/w).

    Science.gov (United States)

    Mitra, Amitava; Kim, Nanhye; Spark, Darren; Toner, Frank; Craig, Susan; Roper, Clive; Meyer, Thomas A

    2016-12-01

    The primary objective of this work was to investigate, using an in vitro human skin permeation study, whether changes in the excipients of butenafine hydrochloride cream would have any effect on bioperformance of the formulation. Such in vitro data would be a surrogate for any requirement of a bioequivalence (BE) study to demonstrate formulation similarity. A LC-MS/MS method for quantitation of butenafine in various matrices was developed and validated. A pilot study was performed to validate the in vitro skin permeation methodology using three cream formulations containing butenafine hydrochloride at concentrations of 0.5, 1.0 and 1.5% (w/w). Finally, a definitive in vitro human skin permeation study was conducted, comparing the extent of butenafine hydrochloride permeation from the new formulation to that from the current formulation. The results of the study comparing the two formulations showed that there was no statistically significant difference in the extent of butenafine permeation into human skin. In conclusion, these in vitro data demonstrated that the formulation change is likely to have no significant impact on the bioperformance of 1% (w/w) butenafine hydrochloride cream. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. Simultaneous determination of codeine, ephedrine, guaiphenesin and chlorpheniramine in beagle dog plasma using high performance liquid chromatography coupled with tandem mass spectrometric detection: application to a bioequivalence study.

    Science.gov (United States)

    Hu, Ziyan; Zou, Qiaogen; Tian, Jixin; Sun, Lili; Zhang, Zunjian

    2011-12-15

    A rapid and sensitive method based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the simultaneous determination of codeine, ephedrine, guaiphenesin and chlorpheniramine in beagle dog plasma has been developed and validated. Following liquid-liquid extraction, the analytes were separated on a reversed-phase C(18) column (150 mm × 2.0 mm, 3 μm) using formic acid:10 mM ammonium acetate:methanol (0.2:62:38, v/v/v) as mobile phase at a flow rate of 0.2 mL/min and analyzed by a triple-quadrupole mass spectrometer in the selected reaction monitoring (SRM) mode. The method was linear for all analytes over the following concentration (ng/mL) ranges: codeine 0.08-16; ephedrine 0.8-160; guaiphenesin 80-16,000; chlorpheniramine 0.2-40. Acceptable precision and accuracy were obtained for concentrations over the standard curve range. It is the first time that the validated HPLC-MS/MS method was successfully applied to a bioequivalence study in 6 healthy beagle dogs. Copyright © 2011 Elsevier B.V. All rights reserved.

  20. Determination of torasemide in human plasma and its bioequivalence study by high-performance liquid chromatography with electrospray ionization tandem mass spectrometry

    Directory of Open Access Journals (Sweden)

    Lin Zhang

    2016-04-01

    Full Text Available A sensitive and selective method using high-performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry (HPLC–ESI–MS to determine the concentration of torasemide in human plasma samples was developed and validated. Tolbutamide was chosen as the internal standard (IS. The chromatography was performed on a Gl Sciences Inertsil ODS-3 column (100 mm×2.1 mm i.d., 5.0 µm within 5 min, using methanol with 10 mM ammonium formate (60:40, v/v as mobile phase at a flow rate of 0.2 mL/min. The targeted compound was detected in negative ionization at m/z 347.00 for torasemide and 269.00 for IS. The linearity range of this method was found to be within the concentration range of 1–2500 ng/mL (r=0.9984 for torasemide in human plasma. The accuracy of this measurement was between 94.05% and 103.86%. The extracted recovery efficiency was from 84.20% to 86.47% at three concentration levels. This method was also successfully applied in pharmacokinetics and bioequivalence studies in Chinese volunteers.

  1. Conclusions and recommendations

    International Nuclear Information System (INIS)

    Carrette, M.

    1997-01-01

    The paper presents conclusions and recommendations at the closing session of the NEA/OECD Workshop held at Fontenay-aux-Roses on 12-14 June 1995. The conclusions refer to issues like: public reaction to foodstuffs containing radioisotope concentrations under the danger standards, possible non-adherence of manufacturers, processors, distributors, et al, to the instructions and guidance from radiation protection specialists, integration of all the food chain factors in the elaboration of the emergency intervention programs, etc. Among the most significant recommendations the following may be mentioned: 1. Differences between different intervention levels and the maximum admissible levels agreed upon by national, regional or international nutrition authorities should be further studied; 2. Problems created by the Chernobyl accident (as for instance, the methods of treatment of food chain products containing unacceptable radioactivity concentrations) are still present and must be solved; 3. Further studies should be done on the socio-cultural aspects of the communication, particularly on the information in rural environment; 4. The preventive measures in agriculture should be implemented as rapidly as possible; 5. In elaborating programmes of agriculture countermeasures, the management of contaminated media, particularly, of forests and their effect on agriculture

  2. Ebola virus: recommendations

    CERN Multimedia

    CERN Medical Service

    2014-01-01

    The CERN Medical Service has been closely following, in particular via the WHO, the development of the Ebola virus outbreak currently affecting some African countries. This infectious disease may be passed on through direct contact with the bodily fluids of a sick person.   Based on the recommendations of the WHO and the two Host States, Switzerland and France, as updated on their respective websites, so far there has been no ban on travel to the countries concerned. However, unless it is absolutely essential, you are advised not to visit any of the countries affected by Ebola (Guinea, Republic of Sierra Leone, Liberia, Nigeria). The two Host States have established an alert system, and a check is carried out on departure from the airports of those countries. It is strongly recommended that you contact the Medical Service if you are travelling to those countries. We remind you to observe the basic rules of hygiene such as frequent hand washing, whatever your destination. The Medical Service is...

  3. Conclusions and recommendations

    International Nuclear Information System (INIS)

    1984-01-01

    The FAO/IAEA/GSF/SIDA Co-ordinated Research Programme on Cereal Grain Protein Improvement by Nuclear Techniques was a follow-up to the FAO/IAEA/GSF Co-ordinated Research Programme on the Use of Nuclear Techniques for Seed Protein Improvement. It was initiated in 1969 and ended in 1981. The objectives of the meeting were to review and evaluate the achievements of the current and previous programmes in order to draw conclusions on the possibility of genetic improvement of cereal grain protein using nuclear techniques, to identify unsolved problems and to discuss and propose possible approaches for their solution. Through reviews and discussions, conclusions and recommendations were made by the participants

  4. Recommendations for skin decontamination

    International Nuclear Information System (INIS)

    1989-01-01

    Further to the reecommendations for determining the surface contamination of the skin and estimating the radiation exposure of the skin after contamination (SAAS-Mitt--89-16), measures for skin decontamination are recommended. They are necessary if (1) after simple decontamination by means of water, soap and brush without damaging the skin the surface contamination limits are exceeded and the radiation exposure to be expected for the undamaged healthy skin is estimated as to high, and if (2) a wound is contaminated. To remove skin contaminations, in general universally applicable, non-aggressive decontamination means and methods are sufficient. In special cases, nuclide-specific decontamination is required taking into account the properties of the radioactive substance

  5. Urgent recommendation. Interim report

    International Nuclear Information System (INIS)

    Nakano, Masayuki

    2000-01-01

    The Investigation Committee for Critical Accident at Uranium Processing Plant was founded immediately after the accident to investigate the cause of the accident and to establish measures to prevent the similar accident. On September 30, 1999 around 10:35, the Japan's first criticality accident occurred at JCO Co. Ltd. Uranium processing plant (auxiliary conversion plant) located at Tokai-mura Ibaraki-ken. The criticality continued on and off for approximately 20 hours after the first instantaneous criticality. The accident led the recommendation of tentative evacuation and sheltering indoors for residents living in the neighborhood. The serious exposure to neutrons happened to three workers. The dominant effect is dose due to neutrons and gamma rays from the precipitation tank. When the accident took place, three workers dissolved sequentially about 2.4 kg uranium powder with 18.8 % enrichment in the 10-litter bucket with nitric acid. The procedure of homogenization of uranium nitrate was supposed to be controlled using the shape-limited narrow storage column. Actually, however, the thick and large precipitation tank was used. As a result, about 16.6 kg of uranium was fed into the tank, which presumably caused criticality. The first notification by JCO was delayed and the following communication was not smooth. This led to the delay of correct understanding of the situation and made the initial proper response difficult, then followed by insufficient communication between the nation, prefecture, and local authority. Urgent recommendations were made on the following items; (1) Safety measures to be taken at the accident site, (2) health cares for residents and others, (3) Comprehensive safety securing at nuclear operators such as Establishment of the effective audit system, Safety education for employees and Qualification and licensing system, Safety related documents, etc. (4) Reconstruction of the government's safety regulations such as How safety regulation

  6. Collaborative Recurrent Neural Networks forDynamic Recommender Systems

    Science.gov (United States)

    2016-11-22

    JMLR: Workshop and Conference Proceedings 63:366–381, 2016 ACML 2016 Collaborative Recurrent Neural Networks for Dynamic Recommender Systems Young...an unprece- dented scale. Although such activity logs are abundantly available, most approaches to recommender systems are based on the rating...Recurrent Neural Network, Recommender System , Neural Language Model, Collaborative Filtering 1. Introduction As ever larger parts of the population

  7. AHA's Recommendations for Physical Activity in Children

    Science.gov (United States)

    ... Check Recipe Certification Program Nutrition Requirements Heart-Check Professional Resources Contact the Heart-Check Certification Program Simple Cooking and Recipes Dining Out Choosing a Restaurant Deciphering ...

  8. Recommendation in evolving online networks

    Science.gov (United States)

    Hu, Xiao; Zeng, An; Shang, Ming-Sheng

    2016-02-01

    Recommender system is an effective tool to find the most relevant information for online users. By analyzing the historical selection records of users, recommender system predicts the most likely future links in the user-item network and accordingly constructs a personalized recommendation list for each user. So far, the recommendation process is mostly investigated in static user-item networks. In this paper, we propose a model which allows us to examine the performance of the state-of-the-art recommendation algorithms in evolving networks. We find that the recommendation accuracy in general decreases with time if the evolution of the online network fully depends on the recommendation. Interestingly, some randomness in users' choice can significantly improve the long-term accuracy of the recommendation algorithm. When a hybrid recommendation algorithm is applied, we find that the optimal parameter gradually shifts towards the diversity-favoring recommendation algorithm, indicating that recommendation diversity is essential to keep a high long-term recommendation accuracy. Finally, we confirm our conclusions by studying the recommendation on networks with the real evolution data.

  9. National Recommended Water Quality Criteria

    Data.gov (United States)

    U.S. Environmental Protection Agency — The National Recommended Water Quality Criteria is a compilation of national recommended water quality criteria for the protection of aquatic life and human health...

  10. Recommended Vaccines for Healthcare Workers

    Science.gov (United States)

    ... Vaccination Resources for Healthcare Professionals Recommended Vaccines for Healthcare Workers Recommend on Facebook Tweet Share Compartir On ... for More Information Resources for Those Vaccinating HCWs Healthcare workers (HCWs) are at risk for exposure to ...

  11. Implementing a Commercial-Strength Parallel Hybrid Movie Recommendation Engine

    DEFF Research Database (Denmark)

    Amolochitis, Emmanouil; Christou, Ioannis T.; Tan, Zheng-Hua

    2014-01-01

    AMORE is a hybrid recommendation system that provides movie recommendations for a major triple-play services provider in Greece. Combined with our own implementations of several user-, item-, and content-based recommendation algorithms, AMORE significantly outperforms other state......-of-the-art implementations both in solution quality and response time. AMORE currently serves daily recommendation requests for all active subscribers of the provider's video-on-demand services and has contributed to an increase of rental profits and customer retention....

  12. Urgent recommendation. Interim report

    Energy Technology Data Exchange (ETDEWEB)

    Nakano, Masayuki [International Affairs and Safeguards Division, Atomic Energy Bureau, Science and Technology Agency, Tokyo (Japan)

    2000-12-01

    The Investigation Committee for Critical Accident at Uranium Processing Plant was founded immediately after the accident to investigate the cause of the accident and to establish measures to prevent the similar accident. On September 30, 1999 around 10:35, the Japan's first criticality accident occurred at JCO Co. Ltd. Uranium processing plant (auxiliary conversion plant) located at Tokai-mura Ibaraki-ken. The criticality continued on and off for approximately 20 hours after the first instantaneous criticality. The accident led the recommendation of tentative evacuation and sheltering indoors for residents living in the neighborhood. The serious exposure to neutrons happened to three workers. The dominant effect is dose due to neutrons and gamma rays from the precipitation tank. When the accident took place, three workers dissolved sequentially about 2.4 kg uranium powder with 18.8 % enrichment in the 10-litter bucket with nitric acid. The procedure of homogenization of uranium nitrate was supposed to be controlled using the shape-limited narrow storage column. Actually, however, the thick and large precipitation tank was used. As a result, about 16.6 kg of uranium was fed into the tank, which presumably caused criticality. The first notification by JCO was delayed and the following communication was not smooth. This led to the delay of correct understanding of the situation and made the initial proper response difficult, then followed by insufficient communication between the nation, prefecture, and local authority. Urgent recommendations were made on the following items; (1) Safety measures to be taken at the accident site, (2) health cares for residents and others, (3) Comprehensive safety securing at nuclear operators such as Establishment of the effective audit system, Safety education for employees and Qualification and licensing system, Safety related documents, etc. (4) Reconstruction of the government's safety regulations such as How safety

  13. Bioequivalence of generic alendronate sodium tablets (70 mg to Fosamax® tablets (70 mg in fasting, healthy volunteers: a randomized, open-label, three-way, reference-replicated crossover study

    Directory of Open Access Journals (Sweden)

    Zhang Y

    2017-07-01

    Full Text Available Yifan Zhang,1 Xiaoyan Chen,1 Yunbiao Tang,2 Youming Lu,1 Lixia Guo,1 Dafang Zhong1 1State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 2Department of Pharmacy, The General Hospital of Shenyang Military Region, Shenyang, People’s Republic of China Purpose: The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax® 70 mg tablet. Materials and methods: A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study period, the volunteers received a single oral dose of the generic or reference product (70 mg. Blood samples were collected at pre-dose and up to 8 h after administration. The bioequivalence of the generic product to the reference product was assessed using the US Food and Drug Administration (FDA and European Medicines Agency (EMA reference-scaled average bioequivalence (RSABE methods. Results: The average maximum concentrations (Cmax of alendronic acid were 64.78±43.76, 56.62±31.95, and 60.15±37.12 ng/mL after the single dose of the generic product and the first and second doses of the reference product, respectively. The areas under the plasma concentration–time curves from time 0 to the last timepoint (AUC0–t were 150.36±82.90, 148.15±85.97, and 167.11±110.87 h·ng/mL, respectively. Reference scaling was used because the within-subject standard deviations of the reference product (sWR for Cmax and AUC0–t were all higher than the cutoff value of 0.294. The 95% upper confidence bounds were -0.16 and -0.17 for Cmax and AUC0–t, respectively, and the point estimates for the generic/reference product ratio were 1.08 and 1.00, which satisfied the RSABE acceptance criteria of the FDA. The 90% CIs for Cmax and AUC0–t were 90.35%–129

  14. Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers.

    Science.gov (United States)

    Parrillo-Campiglia, Susana; Ercoli, Mónica Cedres; Umpierrez, Ofelia; Rodríguez, Patricia; Márquez, Sara; Guarneri, Carolina; Estevez-Parrillo, Francisco T; Laurenz, Marilena; Estevez-Carrizo, Francisco E

    2009-10-01

    Imatinib is a tyrosine kinase inhibitor that has been established as a highly effective therapy for chronic myelogenous leukemia and gastrointestinal stromal tumors. A new generic, once-daily 400-mg tablet of imatinib has been developed by a pharmaceutical company in Argentina, where the regulatory standard for marketing authorization of an imatinib generic is in vitro dissolution testing. The aim of this study was to assess the bioequivalence of a new generic film-coated test tablet formulation versus a film-coated reference tablet formulation of imatinib 400 mg. The local manufacturer seeks to validate the in vitro performance of this new formulation with a bioequivalence study. A randomized, open-label, single-dose, fasting, 2-period, 2-sequence crossover design with a 2-week washout period was used in this study. The study population consisted of healthy male South American (Uruguayan) volunteers, who were assigned in a 1:1 ratio to a randomized sequence (test-reference or reference-test). In each period, the test or reference formulation was administered after an overnight fast. During the 72-hour follow-up period, participants were monitored for vital signs and symptoms. Blood samples were collected at 15 time points, including baseline, until 72 hours. Physical examination and laboratory tests (blood, urine) were repeated 1 week after study completion. A noncompartmental model was used to determine the pharmacokinetic parameters of imatinib. The 90% CIs of the test/reference ratios for AUC(0-infinity) and C(max) were determined; the test and reference formulations were considered bioequivalent if the 90% CIs were between 0.80 and 1.25. Adverse events were assessed by a nurse who administered a questionnaire while the healthy volunteers were admitted in the unit. The bioequivalence study was conducted in 30 Uruguayan male volunteers. Demographic characteristics (mean [SD]) included age, 27.8 (6.5) years; weight, 71.2 (9.8) kg; height, 1.71 (0.09) m; and body

  15. Roussely report: recommendations

    International Nuclear Information System (INIS)

    Anon.

    2010-01-01

    A summary of the Roussely report on how to reinforce and support French nuclear industry, has been made public. This report recommends a series of measures. The main measures are: 1) the quick achievement in the best conditions possible of the Olkiluoto plant, 2) to assure the construction of Flamanville-3 under the best conditions of cost and delay, 3) to benefit totally from the feedback experiences of the construction of Olkiluoto and Flamanville-3 for the construction of Penly-3 and of the English program of EPR, 4) to confirm EDF as a leader for French industrial bids proposing nuclear power plants, 5) to diversify the offer of reactors for international bids, 6) to set a common body of rules for all the employees working in the nuclear sector in France, 7) to support the extension of service life of power reactors up to 60 years if safety is not at stake, 8) to promote French safety regulations at an international scale, and 9) to create a university of nuclear engineering. (A.C.)

  16. Site Recommendation Subsurface Layout

    International Nuclear Information System (INIS)

    C.L. Linden

    2000-01-01

    The purpose of this analysis is to develop a Subsurface Facility layout that is capable of accommodating the statutory capacity of 70,000 metric tons of uranium (MTU), as well as an option to expand the inventory capacity, if authorized, to 97,000 MTU. The layout configuration also requires a degree of flexibility to accommodate potential changes in site conditions or program requirements. The objective of this analysis is to provide a conceptual design of the Subsurface Facility sufficient to support the development of the Subsurface Facility System Description Document (CRWMS M andO 2000e) and the ''Emplacement Drift System Description Document'' (CRWMS M andO 2000i). As well, this analysis provides input to the Site Recommendation Consideration Report. The scope of this analysis includes: (1) Evaluation of the existing facilities and their integration into the Subsurface Facility design. (2) Identification and incorporation of factors influencing Subsurface Facility design, such as geological constraints, thermal loading, constructibility, subsurface ventilation, drainage control, radiological considerations, and the Test and Evaluation Facilities. (3) Development of a layout showing an available area in the primary area sufficient to support both the waste inventories and individual layouts showing the emplacement area required for 70,000 MTU and, if authorized, 97,000 MTU

  17. SPE–UPLC–MS/MS assay for determination of letrozole in human plasma and its application to bioequivalence study in healthy postmenopausal Indian women

    Directory of Open Access Journals (Sweden)

    Pravin G. Vanol

    2016-08-01

    Full Text Available A rapid and sensitive ultra performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS method is described for determination of letrozole in human plasma. Following solid phase extraction (SPE of letrozole and letrozole-d4 on Orochem DVB-LP cartridges, chromatography was performed on Acquity UPLC BEH C18 (50 mm×2.1 mm, 1.7 µm column using methanol-0.1% formic acid in water (85:15, v/v as the mobile phase. Detection was carried out on a triple quadrupole mass spectrometer with an electrospray source, operated under positive ionization mode. Quantitation of letrozole and letrozole-d4 was done using multiple reaction monitoring (MRM following the transitions at m/z 286.2→217.0 and m/z 290.2→221.0, respectively. The calibration plots were linear through the concentration range of 0.10–100 ng/mL (r2≥0.9990 using 100 µL human plasma. The extraction recovery of letrozole ranged from 94.3% to 96.2% and the intra-batch and inter-batch precision was ≤5.2%. The method was successfully applied to a bioequivalence study of letrozole after oral administration of 2.5 mg tablet formulation to 16 healthy postmenopausal Indian women. The assay reproducibility was also established through incurred sample reanalysis (ISR of 74 subject samples.

  18. Application of a rapid and sensitive liquid chromatography-tandem mass spectrometry method for determination of bumetanide in human plasma for a bioequivalence study.

    Science.gov (United States)

    Patel, Dinesh S; Sharma, Naveen; Patel, Mukesh C; Patel, Bhavin N; Shrivastav, Pranav S; Sanyal, Mallika

    2012-07-01

    A rapid, selective and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay has been proposed for the determination of bumetanide in human plasma using tamsulosin as internal standard (IS). The analyte and IS were extracted from 200 μL of human plasma via solid phase extraction and the chromatographic separation was achieved on Peerless Basic C18 (100 mm × 4.6 mm, 3 μm) column under isocratic conditions. Detection of bumetanide and IS was done by tandem mass spectrometry, operating in positive ionization and multiple reaction monitoring (MRM) acquisition mode. The protonated precursor to product ion transitions monitored for bumetanide and IS were m/z 365.2→240.2 and 409.2→228.2 respectively. The method was fully validated as per the US FDA guidelines. The limit of detection and lower limit of quantitation of the method were 0.03 and 0.30 ng/mL respectively with a linear dynamic range of 0.30-200.0 ng/mL for bumetanide. The intra-batch and inter-batch precision (% CV) was ≤6.9% while the mean extraction recovery was >90% across quality control levels. The method is selective in presence of four diuretic drugs and some commonly used medications by healthy volunteers. It was successfully applied to a bioequivalence study of 2mg bumetanide tablet formulation in 10 healthy Indian male subjects under fasting condition. The reproducibility in the measurement of study data was demonstrated by reanalysis of 42 incurred samples. Copyright © 2012 Elsevier B.V. All rights reserved.

  19. A simple and sensitive HPLC method for analysis of imipramine in human plasma with UV detection and liquid-liquid extraction: Application in bioequivalence studies.

    Science.gov (United States)

    Rezazadeh, Mahboubeh; Emami, Jaber

    2016-01-01

    High-performance liquid chromatography (HPLC) methods employing ultraviolet (UV) detector are not sufficiently sensitive to measure the low plasma concentrations following single oral dose of imipramine. Therefore, in the present study a simple, rapid and yet sensitive HPLC method with UV detection was developed and validated for quantitation of imipramine in human plasma samples. An efficient liquid-liquid extraction (LLE) of imipramine from plasma with the mixture of hexane/isoamyl alcohol (98:2) and back extraction of the drug in acidic medium concomitant with evaporation of organic phase allowed the use of UV detector to conveniently measure plasma levels of this compound as low level as 3 ng/ml. Separation was achieved on a μ-Bondapak C18 HPLC column using sodium hydrogen phosphate solution (0.01 M)/acetonitrile (60/40 v/v) at pH 3.5 ± 0.1 at 1.5 ml/min. Trimipramine was used as the internal standard for analysis of plasma samples. The retention times for imipramine and trimipramine were 4.3 and 5.2 min, respectively. Calibration curve was linear in the range of 3-40 ng/ml using human plasma with the average extraction recovery of 85 ± 5%. Imipramine was found to be stable in plasma samples with no evidence of degradation during three freeze-thaw cycles and three months storage at -70°C. The current validated method was finally applied in bioequivalence studies of two different imipramine products according to a standard two-way crossover design with a two weeks washout period.

  20. Determination of ergocalciferol in human plasma after Diels-Alder derivatization by LC–MS/MS and its application to a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Pritesh Contractor

    2017-12-01

    Full Text Available An accurate, sensitive and selective method is developed for determination of ergocalciferol (vitamin D2 in human plasma using LC–MS/MS. After liquid-liquid extraction with n-hexane, ergocalciferol was derivatized by reacting with 4-phenyl-1,2,4-triazoline-3,5-dione (PTAD, a strong dienophile based on Diels-Alder reaction. Ergocalciferol and its deuterated internal standard, ergocalciferol-d6, were analyzed on X Select CSH C18 (100 mm×4.6 mm, 2.5 µm column using acetonitrile and 0.1% (v/v formic acid in water containing 0.14% methylamine within 6.0 min under gradient elution mode. Tandem mass spectrometry in positive ionization mode was used to quantify ergocalciferol by multiple reaction monitoring (MRM. Entire data processing was done using Watson LIMS™ software which provided excellent data integrity and high throughput with improved operational efficiency. The major advantage of this method includes higher sensitivity (0.10 ng/mL, superior extraction efficiency (≥83% and small sample volume (100 µL for processing. The method was linear in the concentration range of 0.10–100 ng/mL for ergocalciferol. The intra-batch and inter-batch accuracy and precision (% CV values varied from 97.3% to 109.0% and 1.01% to 5.16%, respectively. The method was successfully applied to support a bioequivalence study of 1.25 mg ergocalciferol capsules in 12 healthy subjects. Keywords: Ergocalciferol, Diels-Alder reaction, 4-phenyl-1,2,4-triazoline-3,5-dione, LC–MS/MS, Human plasma

  1. Quantitation of itopride in human serum by high-performance liquid chromatography with fluorescence detection and its application to a bioequivalence study.

    Science.gov (United States)

    Singh, Sonu Sundd; Jain, Manish; Sharma, Kuldeep; Shah, Bhavin; Vyas, Meghna; Thakkar, Purav; Shah, Ruchy; Singh, Shriprakash; Lohray, Brajbhushan

    2005-04-25

    A new method was developed for determination of itopride in human serum by reversed phase high-performance liquid chromatography (HPLC) with fluorescence detection (excitation at 291 nm and emission at 342 nm). The method employed one-step extraction of itopride from serum matrix with a mixture of tert-butyl methyl ether and dichloromethane (70:30, v/v) using etoricoxib as an internal standard. Chromatographic separation was obtained within 12.0 min using a reverse phase YMC-Pack AM ODS column (250 mm x 4.6 mm, 5 microm) and an isocratic mobile phase constituting of a mixture of 0.05% tri-fluoro acetic acid in water and acetonitrile (75:25, v/v) flowing at a flow rate of 1.0 ml/min. The method was linear in the range of 14.0 ng/ml to 1000.0 ng/ml. The lower limit of quantitation (LLOQ) was 14.0 ng/ml. Average recovery of itopride and the internal standard from the biological matrix was more than 66.04 and 64.57%, respectively. The inter-day accuracy of the drug containing serum samples was more than 97.81% with a precision of 2.31-3.68%. The intra-day accuracy was 96.91% or more with a precision of 5.17-9.50%. Serum samples containing itopride were stable for 180.0 days at -70+/-5 degrees C and for 24.0 h at ambient temperature (25+/-5 degrees C). The method was successfully applied to the bioequivalence study of itopride in healthy, male human subjects.

  2. Application of an LC–MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Jaivik V. Shah

    2017-10-01

    Full Text Available A sensitive and selective method has been proposed for the simultaneous determination of amlodipine (AML, valsartan (VAL and hydrochlorothiazide (HCTZ in human plasma by liquid chromatography–tandem mass spectrometry (LC–MS/MS. The analytes and their deuterated analogs were quantitatively extracted from 100 µL human plasma by solid phase extraction on Oasis HLB cartridges. The chromatographic separation of the analytes was achieved on a Chromolith RP18e (100 mm × 4.6 mm analytical column within 2.5 min. The resolution factor between AML and VAL, AML and HCTZ, and VAL and HCTZ was 2.9, 1.5 and 1.4, respectively, under isocratic conditions. The method was validated over a dynamic concentration range of 0.02–20.0 ng/mL for AML, 5.00–10,000 ng/mL for VAL and 0.20–200 ng/mL for HCTZ. Ion-suppression/enhancement effects were investigated by post-column infusion technique. The mean IS-normalized matrix factors for AML, VAL and HCTZ were 0.992, 0.994 and 0.998, respectively. The intra-batch and inter-batch precision (% CV across quality control levels was ≤ 5.56% and the recovery was in the range of 93.4%–99.6% for all the analytes. The method was successfully applied to a bioequivalence study of 5 mg AML + 160 mg VAL + 12.5 mg HCTZ tablet formulation (test and reference in 18 healthy Indian males under fasting. The mean log-transformed ratios of Cmax, AUC0–120h and AUC0-inf and their 90% CIs were within 90.2%–102.1%. The assay reproducibility was demonstrated by reanalysis of 90 incurred samples.

  3. Validated LC-MS/MS method for the determination of 3-hydroxflavone and its glucuronide in blood and bioequivalent buffers: application to pharmacokinetic, absorption, and metabolism studies.

    Science.gov (United States)

    Xu, Beibei; Yang, Guanyi; Ge, Shufan; Yin, Taijun; Hu, Ming; Gao, Song

    2013-11-01

    The purpose of this study is to develop an UPLC-MS/MS method to quantify 3-hydroxyflavone (3-HF) and its metabolite, 3-hydroxyflavone-glucuronide (3-HFG) from biological samples. A Waters BEH C8 column was used with acetonitrile/0.1% formic acid in water as mobile phases. The mass analysis was performed in an API 5500 Qtrap mass spectrometer via multiple reaction monitoring (MRM) with positive scan mood. The one-step protein precipitation by acetonitrile was used to extract the analytes from blood. The results showed that the linear response range was 0.61-2500.00 nM for 3-HF and 0.31-2500.00 nM for 3-HFG. The intra-day variance is less than 16.5% and accuracy is in 77.7-90.6% for 3-HF and variance less than 15.9%, accuracy in 85.1-114.7% for 3-HFG. The inter-day variance is less than 20.2%, accuracy is in 110.6-114.2% for 3-HF and variance less than 15.6%, accuracy in 83.0-89.4% for 3-HFG. The analysis was done within 4.0 min. Only 10 μl of blood is needed due to the high sensitivity of this method. The validated method was successfully used to pharmacokinetic study in A/J mouse, transport study in the Caco-2 cell culture model, and glucuronidation study using mice liver and intestine microsomes. The applications revealed that this method can be used for 3-HF and 3-HFG analysis in blood as well as in bioequivalent buffers such HBSS and KPI. Copyright © 2013 Elsevier B.V. All rights reserved.

  4. Justification for recommended uncertainties

    International Nuclear Information System (INIS)

    Pronyaev, V.G.; Badikov, S.A.; Carlson, A.D.

    2007-01-01

    -2 MeV are discussed. The extent to which new measurements and evaluation methodologies will lead to revised results that may differ significantly from the presently recommended data is imponderable. While the present standard values are likely to be closer to the truth than earlier versions, and the given errors are reasonably well justified in the context of contemporary data and evaluation methodology, a healthy open minded attitude remains the most sensible approach, consistent with the fundamental spirit of scientific endeavour and enquiry

  5. Efectos del envejecimiento en las capacidades físicas: implicaciones en las recomendaciones de ejercicio físico en personas mayores. (Effects of aging on physical fitness: implications in the recommendations of physical activity for older adults.

    Directory of Open Access Journals (Sweden)

    Ana Carbonell Baeza

    2009-10-01

    showed to be an useful tool for decelerating the aging process; however, benefits only occur when the physical activity is practiced at the appropriate volume and intensity. Different recommendations for frequency, intensity and duration of physical exercise have been published. The current recommendations for elderly people, determine the minimal criteria for volume and intensity, and they must be taken into consideration when prescribing physical exercise in old people.

  6. Recommendation systems in software engineering

    CERN Document Server

    Robillard, Martin P; Walker, Robert J; Zimmermann, Thomas

    2014-01-01

    With the growth of public and private data stores and the emergence of off-the-shelf data-mining technology, recommendation systems have emerged that specifically address the unique challenges of navigating and interpreting software engineering data.This book collects, structures and formalizes knowledge on recommendation systems in software engineering. It adopts a pragmatic approach with an explicit focus on system design, implementation, and evaluation. The book is divided into three parts: "Part I - Techniques" introduces basics for building recommenders in software engineering, including techniques for collecting and processing software engineering data, but also for presenting recommendations to users as part of their workflow.?"Part II - Evaluation" summarizes methods and experimental designs for evaluating recommendations in software engineering.?"Part III - Applications" describes needs, issues and solution concepts involved in entire recommendation systems for specific software engineering tasks, fo...

  7. Recommendation Sets and Choice Queries

    DEFF Research Database (Denmark)

    Viappiani, Paolo Renato; Boutilier, Craig

    2011-01-01

    Utility elicitation is an important component of many applications, such as decision support systems and recommender systems. Such systems query users about their preferences and offer recommendations based on the system's belief about the user's utility function. We analyze the connection between...... the problem of generating optimal recommendation sets and the problem of generating optimal choice queries, considering both Bayesian and regret-based elicitation. Our results show that, somewhat surprisingly, under very general circumstances, the optimal recommendation set coincides with the optimal query....

  8. Scientific perspectives on extending the provision for waivers of in vivo bioavailability and bioequivalence studies for drug products containing high solubility-low permeability drugs (BCS-Class 3).

    Science.gov (United States)

    Stavchansky, Salomon

    2008-06-01

    Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA-BE) studies that appeared in the guidance published by the Food and Drug Administration (FDA) (1) to pharmaceutical products containing Class 3 drugs (High solubility-Low Permeability). The extension of the Biopharmaceutics Classification System (BCS) to Class 3 drugs is meritorious because of its impact on public health policy considerations. The rate limiting step in the absorption of Class 3 drugs is the permeability through the intestinal membrane. This commentary will focus its attention on the scientific considerations which need to be examined to assess the risk and the benefit prior to granting a waiver of in vivo bioavailability and/or bioequivalence studies for Class 3 drugs. It will examine the forces affecting the interconnectivity of the neuronal, immunological and hormonal systems in the gastrointestinal tract that may affect its permeability and functionality. It will also challenge the assumption that in vitro dissolution and in vitro permeability studies in tissue cultures in the presence and absence of excipients are good predictors for in vivo dissolution and in vivo permeability which are at the heart of the BCS.

  9. Recommendations on the Nature and Level of U.S. Participation in the International Thermonuclear Experimental Reactor Extension of the Experimental Reactor Extension of the Engineering Design Activities. Panel Report To Fusion Energy Sciences Advisory Committee (FESAC)

    International Nuclear Information System (INIS)

    1998-01-01

    The DOE Office of Energy Research chartered through the Fusion Energy Sciences Advisory Committee (FESAC) a panel to 'address the topic of U. S. participation in an ITER construction phase, assuming the ITER Parties decide to proceed with construction.' (Attachment 1: DOE Charge, September 1996). Given that there is expected to be a transition period of three to five years between the conclusion of the Engineering Design Activities (EDA) and the possible construction start, the DOE Office of Energy Research expanded the charge to 'include the U.S. role in an interim period between the EDA and construction.' (Attachment 2: DOE Expanded Charge, May 1997). This panel has heard presentations and received input from a wide cross-section of parties with an interest in the fusion program. The panel concluded it could best fulfill its responsibility under this charge by considering the fusion energy science and technology portion of the U.S. program in its entirety. Accordingly, the panel is making some recommendations for optimum use of the transition period considering the goals of the fusion program and budget pressures.

  10. Classification of Recommender Expertise in the Wikipedia Recommender System

    DEFF Research Database (Denmark)

    Jensen, Christian D.; Pilkauskas, Povilas; Lefévre, Thomas

    2011-01-01

    to the quality of articles. The Wikipedia Recommender System (WRS) was developed to help users determine the credibility of articles based on feedback from other Wikipedia users. The WRS implements a collaborative filtering system with trust metrics, i.e., it provides a rating of articles which emphasizes...... an evaluation of four existing knowledge classification schemes with respect to these requirements. This evaluation helped us identify a classification scheme, which we have implemented in the current version of the Wikipedia Recommender System....... feedback from recommenders that the user has agreed with in the past. This exposes the problem that most recommenders are not equally competent in all subject areas. The first WRS prototype did not include an evaluation of the areas of expertise of recommenders, so the trust metric used in the article...

  11. Classification of Recommender Expertise in the Wikipedia Recommender System

    DEFF Research Database (Denmark)

    Jensen, Christian D.; Pilkauskas, Povilas; Lefevre, Thomas

    2011-01-01

    to the quality of articles. The Wikipedia Recommender System (WRS) was developed to help users determine the credibility of articles based on feedback from other Wikipedia users. The WRS implements a collaborative filtering system with trust metrics, i.e., it provides a rating of articles "which emphasizes...... an evaluation of four existing knowledge classification schemes with respect to these requirements. This evaluation helped us identify a classification scheme, which we have implemented in the current version of the Wikipedia Recommender System....... feedback from recommenders that the user has agreed with in the past. This exposes the problem that most recommenders are not equally competent in all subject areas. The first WRS prototype did not include an evaluation of the areas of expertise of recommenders, so the trust metric used in the article...

  12. Useful and usable alarm systems : recommended properties

    International Nuclear Information System (INIS)

    Veland, Oeystein; Kaarstad, Magnhild; Seim, Lars Aage; Foerdestroemmen, Nils T.

    2001-01-01

    This document describes the result of a study on alarm systems conducted by IFE in Halden. The study was initiated by the Norwegian Petroleum Directorate. The objective was to identify and formulate a set of important properties for useful and usable alarm systems. The study is mainly based on review of the latest international recognised guidelines and standards on alarm systems available at the time of writing, with focus on realistic solutions from research and best practice from different industries. In addition, IFE experiences gathered through specification and design of alarm systems and experimental activities in HAMMLAB and bilateral projects, have been utilized where relevant. The document presents a total of 43 recommendations divided into a number of general recommendations and more detailed recommendations on alarm generation, structuring, prioritisation, presentation and handling. (Author)

  13. Weighted hybrid technique for recommender system

    Science.gov (United States)

    Suriati, S.; Dwiastuti, Meisyarah; Tulus, T.

    2017-12-01

    Recommender system becomes very popular and has important role in an information system or webpages nowadays. A recommender system tries to make a prediction of which item a user may like based on his activity on the system. There are some familiar techniques to build a recommender system, such as content-based filtering and collaborative filtering. Content-based filtering does not involve opinions from human to make the prediction, while collaborative filtering does, so collaborative filtering can predict more accurately. However, collaborative filtering cannot give prediction to items which have never been rated by any user. In order to cover the drawbacks of each approach with the advantages of other approach, both approaches can be combined with an approach known as hybrid technique. Hybrid technique used in this work is weighted technique in which the prediction score is combination linear of scores gained by techniques that are combined.The purpose of this work is to show how an approach of weighted hybrid technique combining content-based filtering and item-based collaborative filtering can work in a movie recommender system and to show the performance comparison when both approachare combined and when each approach works alone. There are three experiments done in this work, combining both techniques with different parameters. The result shows that the weighted hybrid technique that is done in this work does not really boost the performance up, but it helps to give prediction score for unrated movies that are impossible to be recommended by only using collaborative filtering.

  14. Recommendations, requirements, and radioactive particles

    International Nuclear Information System (INIS)

    Bell, J.M.

    1991-01-01

    Hot particles consisting of activated metal debris and fuel fragments have received increased attention in the last five years. This increased attention resulted from the increased use of more sensitive whole body friskers at nuclear power plants, the relatively high local skin doses associated with the particles, and skin dose limits that were established before hot particles, and skin dose limits that were established before hot particles became a problem and before radiobiological effects data for the particles became available. The skin dose distribution and biological effects associated with hot particles differ from those associated with more uniform skin contamination and differences exist in the scientific community as to which effects should be protected against by a limit on exposures from particles. The NRC staff recognized the need for provisions in the Federal regulations specific to hot particle exposures and requested guidance from the National Council on Radiation Protection and Measurements (NCRP). NCRP Report No. 106 was provided to the NRC early in 1990. The International Commission on Radiological Protection (ICRP) is also developing recommendations for limits on exposures from hot particles. The NRC is supporting research on hot particle effects and will likely develop a rule for hot particle exposures

  15. Teacher Leadership: Federal Policy Recommendations

    Science.gov (United States)

    Gran, Jackie; Young, Margaret; Broin, Alexandra

    2015-01-01

    This policy brief was developed specifically for federal policymakers, and builds upon the policy recommendations included in "Leading from Every Seat: Empowering Principals to Cultivate Teacher Leadership for School Improvement." The recommendations in this report include the following: (1) Uncover New Leadership Ideas and Seed…

  16. Recommendation System for Adaptive Learning.

    Science.gov (United States)

    Chen, Yunxiao; Li, Xiaoou; Liu, Jingchen; Ying, Zhiliang

    2018-01-01

    An adaptive learning system aims at providing instruction tailored to the current status of a learner, differing from the traditional classroom experience. The latest advances in technology make adaptive learning possible, which has the potential to provide students with high-quality learning benefit at a low cost. A key component of an adaptive learning system is a recommendation system, which recommends the next material (video lectures, practices, and so on, on different skills) to the learner, based on the psychometric assessment results and possibly other individual characteristics. An important question then follows: How should recommendations be made? To answer this question, a mathematical framework is proposed that characterizes the recommendation process as a Markov decision problem, for which decisions are made based on the current knowledge of the learner and that of the learning materials. In particular, two plain vanilla systems are introduced, for which the optimal recommendation at each stage can be obtained analytically.

  17. Pharmacokinetic and bioequivalence study of a telmisartan/S-amlodipine fixed-dose combination (CKD-828) formulation and coadministered telmisartan and S-amlodipine in healthy subjects.

    Science.gov (United States)

    Kang, Woo Youl; Seong, Sook Jin; Ohk, Boram; Gwon, Mi-Ri; Kim, Bo Kyung; La, Sookie; Kim, Hyun-Ju; Cho, Seungil; Yoon, Young-Ran; Yang, Dong Heon; Lee, Hae Won

    2018-01-01

    be bioequivalent to coadministration of the individual agents with the respective strength, in healthy subjects under fasting conditions. There was no significant difference in safety profile between the two treatments.

  18. The new ICRP general recommendations

    International Nuclear Information System (INIS)

    Sasaki, Y.; Lochard, J.; Holm, L.E.; Niwa, O.; Ishigure, N.; Kosako, T.; Kai, M.

    2007-01-01

    The new draft ICRP recommendations was presented by the ICRP chair, Professor Lars-Eric Holm. His presentation was followed by presentations by Japanese members of the various (CRP committees, discussing their views of the draft recommendations based on their own technical experience. After these presentations, questions from the floor raised many of the key issues of the conference: dose constrains, the LNT hypothesis, dose bands, etc. This showed that the conference participants had carefully and completely read the draft, and were very interested in building a final ICRP recommendation that appropriately addresses all their concerns. These issues were also discussed throughout the entire conference. (author)

  19. RECOMMENDER SYSTEMS IN SOCIAL NETWORKS

    Directory of Open Access Journals (Sweden)

    Cleomar Valois Batista Jr

    2011-12-01

    Full Text Available The continued and diversified growth of social networks has changed the way in which users interact with them. With these changes, what once was limited to social contact is now used for exchanging ideas and opinions, creating the need for new features. Users have so much information at their fingertips that they are unable to process it by themselves; hence, the need to develop new tools. Recommender systems were developed to address this need and many techniques were used for different approaches to the problem. To make relevant recommendations, these systems use large sets of data, not taking the social network of the user into consideration. Developing a recommender system that takes into account the social network of the user is another way of tackling the problem. The purpose of this project is to use the theory of six degrees of separation (Watts 2003 amongst users of a social network to enhance existing recommender systems.

  20. From micronutrient recommendations to policy

    DEFF Research Database (Denmark)

    Timotijevic, Lada; Raats, Monique M.; Barnett, Julie

    2010-01-01

    towards achieving a greater link between micronutrient recommendations and behaviour. This study aims to examine the rationale and processes associated with consumer and stakeholder involvement in setting micronutrient recommendations across Europe. Subjects/Methods: Using the contacts established through......Background/Objectives: To achieve the nutritional goals stipulated by micronutrient recommendations, greater attention must be paid to the behavioural routes to such nutritional outcomes. Coopting stakeholders and consumers into decisions regarding micronutrient recommendations is an important step...... countries and its effect on final decisions. Stakeholders were not involved at the outset of the process ('framing' of the problem) in any of the countries, and there was no evidence of consumer involvement and open public fora. Conclusions: Some of the key explanatory factors for diversity in the degree...

  1. Chapter 6: Conclusions and recommendations

    International Nuclear Information System (INIS)

    1995-01-01

    This chapter provides a brief summary of conclusions with respect to project implementation issues. Furthermore, the chapter contains recommendations on future applications of the modelling system and on water resources management in the project area

  2. TOURISM RECOMMENDATION SYSTEM: EMPIRICAL INVESTIGATION

    OpenAIRE

    Biljana PETREVSKA; Saso KOCESKI

    2012-01-01

    The paper makes an attempt to justify the necessity of implementing recommendation system which will assist tourists in identification of their ideal holiday. The proposed recommendation system based on collaborative filtering notes positive impulses in the case of Macedonia. A software module is developed being capable to generate a personalized list of favorable and tailor-made items. The research outcomes indicate that the designed national tourism web portal can provide satisfactory perfo...

  3. Recommendations

    DEFF Research Database (Denmark)

    Baumeister, Ruth

    2016-01-01

    This article discusses three book publications: C. Kerez: Uncertain Certainty, Tokyo, 2013 H. Hertzberger: Lessons for students in architecture, Rotterdam, 2006, (1991) A. Jorn: Om Formen, Silkeborg, 2014, (1958)......This article discusses three book publications: C. Kerez: Uncertain Certainty, Tokyo, 2013 H. Hertzberger: Lessons for students in architecture, Rotterdam, 2006, (1991) A. Jorn: Om Formen, Silkeborg, 2014, (1958)...

  4. Desidratação e recomendações para a reposição hídrica em crianças fisicamente ativas Dehydration and rehydration recommendations for physically active children

    Directory of Open Access Journals (Sweden)

    Luciana Rossi

    2010-09-01

    heat production. Most studies that address the risks of dehydration and provide recommendations for restoring water are directed to adults living in temperate climate regions, but little is known about the needs of restoring water to physically active children in tropical regions. This review discusses the recommendations for this population and the risks of sports practice in tropical climate areas. DATA SOURCE: Systematic analysis of the national (SciELO and international (Medline literature from 1972 to 2009, with the following keywords, alone or in combination, in Portuguese and English: hydration, children, dehydration and water replacement. DATA SYNTHESIS: There are risks related to dehydration and possible development of hyperthermia especially in adverse weather conditions without adequate fluid replacement. The main trigger for hyperthermia is that, compared to adults, children are less able of adapting to extremes of temperature due to their higher body surface area and lower capacity of thermoregulation by evaporation. Studies on this subject are scarce in face of the questions still open. CONCLUSIONS: Once dehydration factors are known, the best recommendation to aggressive climatic conditions is to establish a replacement program using flavored hydration beverage added with carbohydrates and sodium in order to avoid significant water losses and reduced performance, and to decrease health risks posed by hyperthermia and dehydration to physically active children.

  5. Introduction on health recommender systems.

    Science.gov (United States)

    Sanchez-Bocanegra, C L; Sanchez-Laguna, F; Sevillano, J L

    2015-01-01

    People are looking for appropriate health information which they are concerned about. The Internet is a great resource of this kind of information, but we have to be careful if we don't want to get harmful info. Health recommender systems are becoming a new wave for apt health information as systems suggest the best data according to the patients' needs.The main goals of health recommender systems are to retrieve trusted health information from the Internet, to analyse which is suitable for the user profile and select the best that can be recommended, to adapt their selection methods according to the knowledge domain and to learn from the best recommendations.A brief definition of recommender systems will be given and an explanation of how are they incorporated in the health sector. A description of the main elementary recommender methods as well as their most important problems will also be made. And, to finish, the state of the art will be described.

  6. Hybrid context aware recommender systems

    Science.gov (United States)

    Jain, Rajshree; Tyagi, Jaya; Singh, Sandeep Kumar; Alam, Taj

    2017-10-01

    Recommender systems and context awareness is currently a vital field of research. Most hybrid recommendation systems implement content based and collaborative filtering techniques whereas this work combines context and collaborative filtering. The paper presents a hybrid context aware recommender system for books and movies that gives recommendations based on the user context as well as user or item similarity. It also addresses the issue of dimensionality reduction using weighted pre filtering based on dynamically entered user context and preference of context. This unique step helps to reduce the size of dataset for collaborative filtering. Bias subtracted collaborative filtering is used so as to consider the relative rating of a particular user and not the absolute values. Cosine similarity is used as a metric to determine the similarity between users or items. The unknown ratings are calculated and evaluated using MSE (Mean Squared Error) in test and train datasets. The overall process of recommendation has helped to personalize recommendations and give more accurate results with reduced complexity in collaborative filtering.

  7. Clinical practice recommendations for depression.

    Science.gov (United States)

    Malhi, G S; Adams, D; Porter, R; Wignall, A; Lampe, L; O'Connor, N; Paton, M; Newton, L A; Walter, G; Taylor, A; Berk, M; Mulder, R T

    2009-01-01

    To provide clinically relevant evidence-based recommendations for the management of depression in adults that are informative, easy to assimilate and facilitate clinical decision making. A comprehensive literature review of over 500 articles was undertaken using electronic database search engines (e.g. MEDLINE, PsychINFO and Cochrane reviews). In addition articles, book chapters and other literature known to the authors were reviewed. The findings were then formulated into a set of recommendations that were developed by a multidisciplinary team of clinicians who routinely deal with mood disorders. The recommendations then underwent consultative review by a broader advisory panel that included experts in the field, clinical staff and patient representatives. The clinical practice recommendations for depression (Depression CPR) summarize evidence-based treatments and provide a synopsis of recommendations relating to each phase of the illness. They are designed for clinical use and have therefore been presented succinctly in an innovative and engaging manner that is clear and informative. These up-to-date recommendations provide an evidence-based framework that incorporates clinical wisdom and consideration of individual factors in the management of depression. Further, the novel style and practical approach should promote uptake and implementation.

  8. May one conquer a radiation. Recommendations of experts

    International Nuclear Information System (INIS)

    Zhukovskaya, O.V.; Kovalev, S.D.; Stavrov, A.I.; Rolevich, I.V.; Antsipov, G.V.; Borovikov, A.N.; Baraboshkin, A.V.; Basalaeva, Z.N.

    1996-01-01

    The brief recommendations for the population living on radionuclides contaminated territories on prophylactic feed, agricultural work, keeping of the animals, preparation of food products to use, bee keeping, fishing and hunt, use of production of a forest, hygiene of labour and etc. The recommendations permit to ensure conditions of safe living and activity on contaminated territories. 4 refs., 8 tabs., 1 fig

  9. Recommendation 93-5 Implementation Plan

    International Nuclear Information System (INIS)

    1994-01-01

    On July 19, 1993, the Defense Nuclear Facilities Safety Board (DNFSB) provided to the Secretary of Energy its Recommendation 93-5, which commented on the Hanford Tank Waste Characterization effort. Recommendation 93-5 highlighted the need to accelerate the characterization of the Hanford Site tank wastes to expedite the resolution of identified tank safety issues, and to provide timely design data in support of activities addressing the disposal of the tank wastes. The Department of Energy (DOE) and its prime contractor, Westinghouse Hanford Company (WHC), are in full agreement with the content of Recommendation 93-5 and have prepared this Implementation Plan to document those actions that have been or will be taken to meet Recommendation 93-5. The new Characterization Strategy embodied by this Plan acknowledges that waste distribution within a tank is the critical unknown with respect to successfully characterizing the tank for any Tank Waste Remediation Systems (TWRS) programmatic need. The new strategy has been incorporated into the following seven task: (1) strengthen technical management; (2) accelerate safety related characterization; (3) improve the quality and quantity of sampling (4) streamline tank access; (5) improve the quality and quantity of analyses; (6) improve data management; and (7) change control

  10. The expert meeting dedicated to the discussion of results of a local open-label multicenter observational study of the efficiency and safety of tofacitinib in patients with active rheumatoid arthritis with the inefficiency of disease-modifying antirheumatic drugs and to the elaboration of recommendations for the use for tofacitinib in the therapy of rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    2016-01-01

    Full Text Available The expert meeting dedicated to the discussion of results of a local open-label multicenter observational study of the efficiency and safety of tofacitinib in patients with active rheumatoid arthritis with the inefficiency of disease-modifying antirheumatic drugs and to the elaboration of recommendations for the use for tofacitinib in the therapy of rheumatoid arthritis.

  11. Improved collaborative filtering recommendation algorithm of similarity measure

    Science.gov (United States)

    Zhang, Baofu; Yuan, Baoping

    2017-05-01

    The Collaborative filtering recommendation algorithm is one of the most widely used recommendation algorithm in personalized recommender systems. The key is to find the nearest neighbor set of the active user by using similarity measure. However, the methods of traditional similarity measure mainly focus on the similarity of user common rating items, but ignore the relationship between the user common rating items and all items the user rates. And because rating matrix is very sparse, traditional collaborative filtering recommendation algorithm is not high efficiency. In order to obtain better accuracy, based on the consideration of common preference between users, the difference of rating scale and score of common items, this paper presents an improved similarity measure method, and based on this method, a collaborative filtering recommendation algorithm based on similarity improvement is proposed. Experimental results show that the algorithm can effectively improve the quality of recommendation, thus alleviate the impact of data sparseness.

  12. Estudio de bioequivalencia: formulaciones genéricas y comerciales de estaduvine, lamiduvine, zidovudine e indinavir en pacientes cubanos infectados con VIH Bioequivalence study: generic and trade formulations of stavudine, lamivudine, zidovudine and indinavir in Cuban HIV-infected subjects

    Directory of Open Access Journals (Sweden)

    Alicia Tarinas Reyes

    2006-08-01

    Full Text Available Objetivo: El presente estudio describe los estudios de bioequivalencia de los genéricos cubanos antirretrovirales estavudina, lamivudina, zidovudina e indinavir con respecto a sus productos innovadores. Diseño: Los estudios de bioequivalencia de cada antirretroviral estudiado (formulación de prueba, P y referencia, R, se realizaron en 13 ó 14 sujetos, según el caso con la utilización de las medias en un estudio aleatorio, cruzado y a dosis única con un período de lavado de 10 días. Métodos: Las concentración de los antirretrovirales en plasma se monitorearon durante un período de 12 h después de la administración de estos, mediante el uso de métodos validados de cromatografía líquida de alta resolución (HPLC. Los parámetros farmacocinéticos se determinaron con el uso el software profesional WinNolin, versión 2.1. La comparación de los parámetros farmacocinéticos se realizó con un intervalo de confianza del 95 % con la utilización del software NCSS 2000 PASS 2000 (hipótesis nula. Para el estudio de bioequivalencia se usó el software Equiv Test de soluciones estadísticas, empleando ANOVA con el 90 % de intervalo de confianza. Resultados: El presente estudio mostró que no se observaron diferencias significativas en las medias de AUC0-12, AUC0-¥, Cmax y Tmax de ambas formulaciones de estavudina, lamivudina, zidovudina e indinavir. Se concluye que los parámetros farmacocinéticos estudiados se encuentran dentro de los rangos establecidos siendo 80-125 % para Cmax, AUC0-12, y AUC0-¥. En el caso de Cmax de la zidovudina el rango fue 70-143 %. Conclusión: Estos resultados avalan que los genéricos antirretrovirales cubanos son bioequivalentes con sus respectivos productos innovadores en términos de velocidad y magnitud de la absorciónObjective: The present study describes the determination of the bioequivalence of the Cuban generic and trade formulations of stavudine, lamivudine, zidovudine, and indinavir. Design: The

  13. Pharmacokinetic and bioequivalence study of a telmisartan/S-amlodipine fixed-dose combination (CKD-828 formulation and coadministered telmisartan and S-amlodipine in healthy subjects

    Directory of Open Access Journals (Sweden)

    Kang WY

    2018-03-01

    concomitantly administered, respectively. The mean Cmax and AUC0–t values of S-amlodipine were 2.71 ng/mL and 130.69 ng⋅h/mL for the FDC, and 2.74 ng/mL and 129.81 ng⋅h/mL for the individual agents concomitantly administered, respectively. The geometric mean ratio (GMR and 90% confidence interval (CI for the telmisartan Cmax and AUC0–t (FDC of telmisartan and S-amlodipine/concomitant administration were 0.8509 (0.7353–0.9846 and 0.9431 (0.8698–1.0226, respectively. The GMR and 90% CI for the S-amlodipine Cmax and AUC0–t (FDC/concomitant administration were 0.9829 (0.9143–1.0567 and 0.9632 (0.8798–1.0546, respectively. As the intrasubject variability of the Cmax for telmisartan administered individually was 42.94%, all 90% CIs of the GMRs fell within the predetermined acceptance range. Both treatments were well tolerated in this study. Conclusion: CKD-828 FDC tablets were shown to be bioequivalent to coadministration of the individual agents with the respective strength, in healthy subjects under fasting conditions. There was no significant difference in safety profile between the two treatments. Keywords: fixed-dose combination, pharmacokinetics, S-amlodipine, telmisartan, safety

  14. Bioequivalence and Safety of Twice-Daily Sustained-Release Paracetamol (Acetaminophen) Compared With 3- and 4-Times-Daily Paracetamol: A Repeat-Dose, Crossover Pharmacokinetic Study in Healthy Volunteers.

    Science.gov (United States)

    Liu, Dongzhou J; Collaku, Agron

    2018-01-01

    Twice-daily sustained-release (SR) paracetamol (acetaminophen) offers convenient administration to chronic users. This study investigated at steady state (during the last 24 hours of a 3-day dosing period) the pharmacokinetics, bioequivalence, and safety of twice-daily SR paracetamol compared with extended-release (ER) and immediate-release (IR) paracetamol. In this open-label, randomized, multidose, 3-way crossover study, 28 healthy subjects received paracetamol SR (2 × 1000 mg twice daily), ER (2 × 665 mg 3 times daily), and IR (2 × 500 mg 4 times daily). At steady state, twice-daily SR paracetamol was bioequivalent to ER and IR paracetamol. The 90% confidence intervals for the ratios of geometric means were within the acceptance interval for SR/ER paracetamol (AUC 0-t , 0.973-1.033; AUC 0-24 , 0.974-1.034; AUC 0-∞ , 0.948-1.011; C max , 1.082-1.212; C av , 1.011-1.106) and SR/IR paracetamol (AUC 0-t , 0.969-1.029; AUC 0-24 , 0.968-1.027; AUC 0-∞ , 0.963-1.026; C max , 0.902-1.010; C av , 1.004-1.098). Given twice daily, the SR formulation demonstrated SR properties as expected. Mean time at or above a 4 μg/mL plasma concentration of paracetamol from 2 daily doses of the SR formulation was significantly longer than that from 4 daily doses of IR paracetamol. SR formulation also had a greater T max , a longer half-life, and lower C min compared with ER and IR paracetamol. All formulations were well tolerated. © 2017, The American College of Clinical Pharmacology.

  15. Personalized recommendation with corrected similarity

    International Nuclear Information System (INIS)

    Zhu, Xuzhen; Tian, Hui; Cai, Shimin

    2014-01-01

    Personalized recommendation has attracted a surge of interdisciplinary research. Especially, similarity-based methods in applications of real recommendation systems have achieved great success. However, the computations of similarities are overestimated or underestimated, in particular because of the defective strategy of unidirectional similarity estimation. In this paper, we solve this drawback by leveraging mutual correction of forward and backward similarity estimations, and propose a new personalized recommendation index, i.e., corrected similarity based inference (CSI). Through extensive experiments on four benchmark datasets, the results show a greater improvement of CSI in comparison with these mainstream baselines. And a detailed analysis is presented to unveil and understand the origin of such difference between CSI and mainstream indices. (paper)

  16. TOURISM RECOMMENDATION SYSTEM: EMPIRICAL INVESTIGATION

    Directory of Open Access Journals (Sweden)

    Biljana PETREVSKA

    2012-12-01

    Full Text Available The paper makes an attempt to justify the necessity of implementing recommendation system which will assist tourists in identification of their ideal holiday. The proposed recommendation system based on collaborative filtering notes positive impulses in the case of Macedonia. A software module is developed being capable to generate a personalized list of favorable and tailor-made items. The research outcomes indicate that the designed national tourism web portal can provide satisfactory performance and may be of high importance to all key-tourism actors in the process of identifying measures necessary for creating competitive tourism product.

  17. Earth Observing System, Conclusions and Recommendations

    Science.gov (United States)

    1984-01-01

    The following Earth Observing Systems (E.O.S.) recommendations were suggested: (1) a program must be initiated to ensure that present time series of Earth science data are maintained and continued. (2) A data system that provides easy, integrated, and complete access to past, present, and future data must be developed as soon as possible. (3) A long term research effort must be sustained to study and understand these time series of Earth observations. (4) The E.O.S. should be established as an information system to carry out those aspects of the above recommendations which go beyond existing and currently planned activities. (5) The scientific direction of the E.O.S. should be established and continued through an international scientific steering committee.

  18. Radiation protection: Principles, recommendations and regulations

    International Nuclear Information System (INIS)

    Reitan, J.B.

    1989-01-01

    Radiation protection is a highly international dicipline with a high degree of international harmonization. Especially within the Nordic countries there is general agreement upon principles and standards, despite the actual practice may differ slightly. The basic recommendations of the International Commission on Radiological Protection (ICRP) are accepted by the regulatory bodies and should be followed by all users of radiation. The users are in principle responsible for the radiation protection standard and activities themselves. Because most companies or hospitals lack sufficient expertise by themselves, they must rely upon recommendations from others. Primarily they should contact the national radiation protection agency. However, due to the international harmonization of radiation protection, information from other national or international agencies may be used with confidence. All users of radiation in the Nordic countries are obliged to act according to recognition and assessment of both risks and benefits, and they are responsible for updating their knowledge

  19. Measuring Physical Activity Intensity

    Medline Plus

    Full Text Available ... Adults Need More Physical Activity MMWR Data Highlights State Indicator Report on Physical Activity, 2014 Recommendations & Guidelines ... Activity Overweight & Obesity Healthy Weight Breastfeeding Micronutrient Malnutrition State and Local Programs Measuring Physical Activity Intensity Recommend ...

  20. May I suggest? Three PLE recommender strategies in comparison

    OpenAIRE

    Mödritscher, Felix; Krumay, Barbara; El Helou, Sandy; Gillet, Denis; Nussbaumer, Alexander; Albert, Dietrich; Dahn, Ingo; Ullrich, Carsten

    2011-01-01

    Personal learning environment (PLE) solutions aim at empowering learners to design (ICT and web-based) environments for their activities in different learning contexts and even for transitions between these contexts. Hereby, recommender systems which are highly successful in other application areas comprise one relevant technology for supporting learners in PLE-based activities. In this paper we examine the utilization of recommender technology for PLEs. However, being confronted by a variety...

  1. Towards a Legal Recommender System

    NARCIS (Netherlands)

    Winkels, R.; Boer, A.; Vredebregt, B.; van Someren, A.

    2014-01-01

    In this paper we present the results of ongoing research aimed at a legal recommender system where users of a legislative portal receive suggestions of other relevant sources of law, given a focus document. We describe how we make references in case law to legislation explicit and machine readable,

  2. Ubiquitous Multicriteria Clinic Recommendation System.

    Science.gov (United States)

    Chen, Toly

    2016-05-01

    Advancements in information, communication, and sensor technologies have led to new opportunities in medical care and education. Patients in general prefer visiting the nearest clinic, attempt to avoid waiting for treatment, and have unequal preferences for different clinics and doctors. Therefore, to enable patients to compare multiple clinics, this study proposes a ubiquitous multicriteria clinic recommendation system. In this system, patients can send requests through their cell phones to the system server to obtain a clinic recommendation. Once the patient sends this information to the system, the system server first estimates the patient's speed according to the detection results of a global positioning system. It then applies a fuzzy integer nonlinear programming-ordered weighted average approach to assess four criteria and finally recommends a clinic with maximal utility to the patient. The proposed methodology was tested in a field experiment, and the experimental results showed that it is advantageous over two existing methods in elevating the utilities of recommendations. In addition, such an advantage was shown to be statistically significant.

  3. [Organizational recommendations for day surgery].

    Science.gov (United States)

    Bontemps, Gilles

    2014-03-01

    In France, the delayed development of day surgery compared to other countries led the ANAP and the HAS in 2011 to enter into a joint work program to provide some reference guide for hospitals to change their practices to outpatient. In this context, organizational guidelines and operational tools were published in May 2013. The method of construction of the recommendations resulting from an original work that combined a three-fold approach: field vision by identifying the highlights of 15 hospitals selected for their representative performance and analyzing the risks of five voluntary hospitals, mobilization organizational theories from the social sciences, using 53 professional experts. The work concluded on 16 organizational recommendations under four forms (basic principles, strategic elements, operational elements and perspectives). These recommendations are accompanied by tools and guides diagnosis and implementation, as well as productions for further reflection. These organizational recommendations confirmed the specificity of day surgery, which is not related to the act, but to the organization, management and optimization of different flows of a hospital (patient flow, professional flows, logistical, informational…). The performance of a day surgery organization is linked to its ability to control its flow and anticipation. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  4. Recommendations for DSD model calculations

    International Nuclear Information System (INIS)

    Cvelbar, F.

    1999-01-01

    The latest achievements of the DSD (direct-semidirect) capture model, such as the extension to unbound final states or to densely distributed bound states, and the introduction of the consistent DSD model are reviewed. Recommendations for the future use of the model are presented. (author)

  5. Recommendations for open data science.

    Science.gov (United States)

    Gymrek, Melissa; Farjoun, Yossi

    2016-01-01

    Life science research increasingly relies on large-scale computational analyses. However, the code and data used for these analyses are often lacking in publications. To maximize scientific impact, reproducibility, and reuse, it is crucial that these resources are made publicly available and are fully transparent. We provide recommendations for improving the openness of data-driven studies in life sciences.

  6. Recommendations for Institutional Prematriculation Immunizations

    Science.gov (United States)

    Journal of American College Health, 2011

    2011-01-01

    The recommendations presented in this article are provided to colleges and universities to facilitate the implementation of a comprehensive institutional prematriculation immunization policy. Vaccine-preventable diseases continue to occur on American campuses. In response to changing epidemiology and the introduction of new vaccines, the ACHA…

  7. TDCCREC: AN EFFICIENT AND SCALABLE WEB-BASED RECOMMENDATION SYSTEM

    Directory of Open Access Journals (Sweden)

    K.Latha

    2010-10-01

    Full Text Available Web browsers are provided with complex information space where the volume of information available to them is huge. There comes the Recommender system which effectively recommends web pages that are related to the current webpage, to provide the user with further customized reading material. To enhance the performance of the recommender systems, we include an elegant proposed web based recommendation system; Truth Discovery based Content and Collaborative RECommender (TDCCREC which is capable of addressing scalability. Existing approaches such as Learning automata deals with usage and navigational patterns of users. On the other hand, Weighted Association Rule is applied for recommending web pages by assigning weights to each page in all the transactions. Both of them have their own disadvantages. The websites recommended by the search engines have no guarantee for information correctness and often delivers conflicting information. To solve them, content based filtering and collaborative filtering techniques are introduced for recommending web pages to the active user along with the trustworthiness of the website and confidence of facts which outperforms the existing methods. Our results show how the proposed recommender system performs better in predicting the next request of web users.

  8. A Flexible Electronic Commerce Recommendation System

    Science.gov (United States)

    Gong, Songjie

    Recommendation systems have become very popular in E-commerce websites. Many of the largest commerce websites are already using recommender technologies to help their customers find products to purchase. An electronic commerce recommendation system learns from a customer and recommends products that the customer will find most valuable from among the available products. But most recommendation methods are hard-wired into the system and they support only fixed recommendations. This paper presented a framework of flexible electronic commerce recommendation system. The framework is composed by user model interface, recommendation engine, recommendation strategy model, recommendation technology group, user interest model and database interface. In the recommender strategy model, the method can be collaborative filtering, content-based filtering, mining associate rules method, knowledge-based filtering method or the mixed method. The system mapped the implementation and demand through strategy model, and the whole system would be design as standard parts to adapt to the change of the recommendation strategy.

  9. Multimedia services in intelligent environments recommendation services

    CERN Document Server

    Virvou, Maria; Jain, Lakhmi

    2013-01-01

    Multimedia services are now commonly used in various activities in the daily lives of humans. Related application areas include services that allow access to large depositories of information, digital libraries, e-learning and e-education, e-government and e-governance, e-commerce and e-auctions, e-entertainment, e-health and e-medicine, and e-legal services, as well as their mobile counterparts (i.e., m-services). Despite the tremendous growth of multimedia services over the recent years, there is an increasing demand for their further development. This demand is driven by the ever-increasing desire of society for easy accessibility to information in friendly, personalized and adaptive environments. In this book at hand, we examine recent Recommendation Services. Recommendation services appear in the mobile environment, medicine/biology, tourism, education, and so on. The book includes ten chapters, which present various recently developed recommendation services. This research book is directed to professors...

  10. Virtual goods recommendations in virtual worlds.

    Science.gov (United States)

    Chen, Kuan-Yu; Liao, Hsiu-Yu; Chen, Jyun-Hung; Liu, Duen-Ren

    2015-01-01

    Virtual worlds (VWs) are computer-simulated environments which allow users to create their own virtual character as an avatar. With the rapidly growing user volume in VWs, platform providers launch virtual goods in haste and stampede users to increase sales revenue. However, the rapidity of development incurs virtual unrelated items which will be difficult to remarket. It not only wastes virtual global companies' intelligence resources, but also makes it difficult for users to find suitable virtual goods fit for their virtual home in daily virtual life. In the VWs, users decorate their houses, visit others' homes, create families, host parties, and so forth. Users establish their social life circles through these activities. This research proposes a novel virtual goods recommendation method based on these social interactions. The contact strength and contact influence result from interactions with social neighbors and influence users' buying intention. Our research highlights the importance of social interactions in virtual goods recommendation. The experiment's data were retrieved from an online VW platform, and the results show that the proposed method, considering social interactions and social life circle, has better performance than existing recommendation methods.

  11. Patients Provide Recommendations for Improving Patient Satisfaction.

    Science.gov (United States)

    Moore, Angelo D; Hamilton, Jill B; Krusel, Jessica L; Moore, LeeAntoinette G; Pierre-Louis, Bosny J

    2016-04-01

    National Committee for Quality Assurance recommends patient-centered medical homes incorporate input from patient populations; however, many health care organizations do not. This qualitative study used two open-ended questions from 148 active duty Army Soldiers and their family members to illicit recommendations for primary care providers and clinic leadership that would improve their health care experiences. Content analysis and descriptive statistics were used to analyze responses. Participant responses were related to four major themes: Access to Care, Interpersonal Interaction, Satisfaction of Care, and Quality of Care. Participants were overall satisfied with their care; however, spending less time waiting for appointments and to see the provider or specialist were the most frequently requested improvements related to Access to Care. For Interpersonal Interaction, 82% of the responses recommended that providers be more attentive listeners, courteous, patient, caring, and respectful. Decreasing wait times and improving interpersonal skills would improve health care experiences and patient satisfaction. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

  12. Respectful doubts on the new ICRP recommendations

    International Nuclear Information System (INIS)

    Diaz de la Cruz, F.

    1992-01-01

    The admiration and deference an International Organization, as ICRP, deserves not only by its altruistic mission but also by the eminent and distinguished scientists who work for it, in some way 'dazzles' to simple students of its theories and, in some way 'force' us to accept, sometimes without any critical, serious and previous meditation, its recommendations. But it is not the bad thing this kind of 'blindness' we have before the almighty ...ICRP dixit..., the worst thing is that non-specialist and non-specialized persons believe as 'dogmas' and 'axioms' the ICRP recommednations and make of them legal dispositions through standards and regulations. Standards an regulations which can frustate an industrial or any other type of peaceful nuclear activity due to the economic or the social reasons derived from ICRP recommendations. The inflexibility (weakened in the arguments but strengthened in the recommendations) of this influent Organism on the 'linearity without threshold' in the dose-effect relationship and the compromises of the International Labor Organization (ILO) with respect ICRP recommedations provole irrational, ilogical and non desirable answers. (author)

  13. RARD: The Related-Article Recommendation Dataset

    OpenAIRE

    Beel, Joeran; Carevic, Zeljko; Schaible, Johann; Neusch, Gabor

    2017-01-01

    Recommender-system datasets are used for recommender-system evaluations, training machine-learning algorithms, and exploring user behavior. While there are many datasets for recommender systems in the domains of movies, books, and music, there are rather few datasets from research-paper recommender systems. In this paper, we introduce RARD, the Related-Article Recommendation Dataset, from the digital library Sowiport and the recommendation-as-a-service provider Mr. DLib. The dataset contains ...

  14. Missed hormonal contraceptives: new recommendations.

    Science.gov (United States)

    Guilbert, Edith; Black, Amanda; Dunn, Sheila; Senikas, Vyta

    2008-11-01

    To provide evidence-based guidance for women and their health care providers on the management of missed or delayed hormonal contraceptive doses in order to prevent unintended pregnancy. Medline, PubMed, and the Cochrane Database were searched for articles published in English, from 1974 to 2007, about hormonal contraceptive methods that are available in Canada and that may be missed or delayed. Relevant publications and position papers from appropriate reproductive health and family planning organizations were also reviewed. The quality of evidence is rated using the criteria developed by the Canadian Task Force on Preventive Health Care. This committee opinion will help health care providers offer clear information to women who have not been adherent in using hormonal contraception with the purpose of preventing unintended pregnancy. The Society of Obstetricians and Gynaecologists of Canada. SUMMARY STATEMENTS: 1. Instructions for what women should do when they miss hormonal contraception have been complex and women do not understand them correctly. (I) 2. The highest risk of ovulation occurs when the hormone-free interval is prolonged for more than seven days, either by delaying the start of combined hormonal contraceptives or by missing active hormone doses during the first or third weeks of combined oral contraceptives. (II) Ovulation rarely occurs after seven consecutive days of combined oral contraceptive use. (II) RECOMMENDATIONS: 1. Health care providers should give clear, simple instructions, both written and oral, on missed hormonal contraceptive pills as part of contraceptive counselling. (III-A) 2. Health care providers should provide women with telephone/electronic resources for reference in the event of missed or delayed hormonal contraceptives. (III-A) 3. In order to avoid an increased risk of unintended pregnancy, the hormone-free interval should not exceed seven days in combined hormonal contraceptive users. (II-A) 4. Back-up contraception should

  15. Scientific and educational recommender systems

    Science.gov (United States)

    Guseva, A. I.; Kireev, V. S.; Bochkarev, P. V.; Kuznetsov, I. A.; Philippov, S. A.

    2017-01-01

    This article discusses the questions associated with the use of reference systems in the preparation of graduates in physical function. The objective of this research is creation of model of recommender system user from the sphere of science and education. The detailed review of current scientific and social network for scientists and the problem of constructing recommender systems in this area. The result of this study is to research user information model systems. The model is presented in two versions: the full one - in the form of a semantic network, and short - in a relational form. The relational model is the projection in the form of semantic network, taking into account the restrictions on the amount of bonds that characterize the number of information items (research results), which interact with the system user.

  16. 75 FR 64389 - Proposed Recommendation to the Social Security Administration for Occupational Information System...

    Science.gov (United States)

    2010-10-19

    ... SOCIAL SECURITY ADMINISTRATION [Docket No. SSA-2010-0066] Proposed Recommendation to the Social Security Administration for Occupational Information System (OIS) Development Planning; Request for Comment...) to provide independent advice and recommendations on plans and activities to create an occupational...

  17. Latin America Regional Seminar 'Civil-Military Responses to Terrorism' Group Recommendations

    OpenAIRE

    Shemella, Paul

    2004-01-01

    Given the high degree of cultural continuity in the region, we recommend proposing a common definition of terrorism to guide national policy formulation for responding to terrorist activities. We further recommend...

  18. Finding and Recommending Scholarly Articles

    Science.gov (United States)

    Kurtz, Michael J.; Henneken, Edwin A.

    2014-05-01

    The rate at which scholarly literature is being produced has been increasing at approximately 3.5 percent per year for decades. This means that during a typical 40 year career the amount of new literature produced each year increases by a factor of four. The methods scholars use to discover relevant literature must change. Just like everybody else involved in information discovery, scholars are confronted with information overload. Two decades ago, this discovery process essentially consisted of paging through abstract books, talking to colleagues and librarians, and browsing journals. A time-consuming process, which could even be longer if material had to be shipped from elsewhere. Now much of this discovery process is mediated by online scholarly information systems. All these systems are relatively new, and all are still changing. They all share a common goal: to provide their users with access to the literature relevant to their specific needs. To achieve this each system responds to actions by the user by displaying articles which the system judges relevant to the user's current needs. Recently search systems which use particularly sophisticated methodologies to recommend a few specific papers to the user have been called "recommender systems". These methods are in line with the current use of the term "recommender system" in computer science. We do not adopt this definition, rather we view systems like these as components in a larger whole, which is presented by the scholarly information systems themselves. In what follows we view the recommender system as an aspect of the entire information system; one which combines the massive memory capacities of the machine with the cognitive abilities of the human user to achieve a human-machine synergy.

  19. Group Recommendation in Social Networks

    Science.gov (United States)

    2011-01-01

    interests 8,822,921 DOUBAN Largest Chinese community providing user review and recommendation services for movies, books, and music . It also...doubles up as the Chinese language book, movie and music database. 46,850,000 FACEBOOK General 750,000,000+ FLIXSTER Movies 32,000,000 FOURSQUARE...groups, events and community pages) • More than 30 billion pieces of content (web links, news stories, blog posts, notes, photo albums , etc.) shared

  20. Workers and the ICRP recommendations

    International Nuclear Information System (INIS)

    Zerbib, J.C.

    1979-01-01

    In both the preparation and the application of the recommendations presented by the ICRP one important voice has been absent: that of the workers in the nuclear industry. A large number of specialists are studying their situation from all points of view, in their different capacities as workers, consumers and male or female members of the public, but this extensive study is being done without consulting them, without their opinion even being asked for. The paper discusses such deficiencies, in particular all those aspects which distinguish these recommendations from a legal text. The lack of conciseness in the definition of the limit which the average annual dose to a large group of workers must not exceed (500 mrad) is considered. The possibility of a large number of workers being exposed for a long period is not acceptable if the decision is left to the manager of a nuclear facility alone. Cost-benefit analysis, as it is described in the ICRP text, cannot be considered to provide credible protection from the point of view of workers. Moreover, the various ICRP recommendations fail to mention such important matters as allowance for low-dose effects, disparities in the social security coverage offered to various categories of workers in the event of occupational illness, and the increasing use of migrant workers for difficult decontamination and maitenance tasks. At a time when it is thought that nuclear technology can be standardized, the French Democratic Labour Confederation (CFDT) expresses its fears concerning the practical application of the ICRP recommendations; for example, the text of ICRP Publication 26 has not yet been translated into French, but Euratom has already proposed directives for its application in Member States

  1. Recommended HSE-7 documents hierarchy

    International Nuclear Information System (INIS)

    Klein, R.B.; Jennrich, E.A.; Lund, D.M.; Danna, J.G.; Davis, K.D.; Rutz, A.C.

    1990-01-01

    This report recommends a hierarchy of waste management documents at Los Alamos National Laboratory (LANL or ''Laboratory''). The hierarchy addresses documents that are required to plan, implement, and document waste management programs at Los Alamos. These documents will enable the waste management group and the six sections contained within that group to satisfy requirements that are imposed upon them by the US Department of Energy (DOE), DOE Albuquerque Operations, US Environmental Protection Agency, various State of New Mexico agencies, and Laboratory management

  2. Paris convention - Decisions, recommendations, interpretations

    International Nuclear Information System (INIS)

    1990-01-01

    This booklet is published in a single edition in English and French. It contains decisions, recommendations and interpretations concerning the 1960 Paris Convention on Third Party Liability in the Field of Nuclear Energy adopted by the OECD Steering Committee and the OECD Council. All the instruments are set out according to the Article of the Convention to which they relate and explanatory notes are added where necessary [fr

  3. Aggregated recommendation through random forests.

    Science.gov (United States)

    Zhang, Heng-Ru; Min, Fan; He, Xu

    2014-01-01

    Aggregated recommendation refers to the process of suggesting one kind of items to a group of users. Compared to user-oriented or item-oriented approaches, it is more general and, therefore, more appropriate for cold-start recommendation. In this paper, we propose a random forest approach to create aggregated recommender systems. The approach is used to predict the rating of a group of users to a kind of items. In the preprocessing stage, we merge user, item, and rating information to construct an aggregated decision table, where rating information serves as the decision attribute. We also model the data conversion process corresponding to the new user, new item, and both new problems. In the training stage, a forest is built for the aggregated training set, where each leaf is assigned a distribution of discrete rating. In the testing stage, we present four predicting approaches to compute evaluation values based on the distribution of each tree. Experiments results on the well-known MovieLens dataset show that the aggregated approach maintains an acceptable level of accuracy.

  4. Efficient Tensor Strategy for Recommendation

    Directory of Open Access Journals (Sweden)

    Aboagye Emelia Opoku

    2017-07-01

    Full Text Available The era of big data has witnessed the explosion of tensor datasets, and large scale Probabilistic Tensor Factorization (PTF analysis is important to accommodate such increasing trend of data. Sparsity, and Cold-Start are some of the inherent problems of recommender systems in the era of big data. This paper proposes a novel Sentiment-Based Probabilistic Tensor Analysis technique senti-PTF to address the problems. The propose framework first applies a Natural Language Processing technique to perform sentiment analysis taking advantage of the huge sums of textual data generated available from the social media which are predominantly left untouched. Although some current studies do employ review texts, many of them do not consider how sentiments in reviews influence recommendation algorithm for prediction. There is therefore this big data text analytics gap whose modeling is computationally expensive. From our experiments, our novel machine learning sentiment-based tensor analysis is computationally less expensive, and addresses the cold-start problem, for optimal recommendation prediction.

  5. Vaccination recommended for pregnant women

    Directory of Open Access Journals (Sweden)

    Justyna Magdalena Skolarczyk

    2017-04-01

    Full Text Available A vaccine is a formulation of biological origin that contains substances capable of inducing immune processes without the ability to cause a disease. Vaccination is considered the best mean to prevent infectious diseases and their serious complications. Vaccination of a pregnant women can provide protection against severe infectious diseases of both pregnant women and their children. The aim of the study is to present currently available types of vaccines recommended for pregnant women and indications for their use by analyzing the data available in the PubMed, and Medline electronic databases. In the United States, vaccination recommendations for pregnant women include inactivated influenza vaccine and tetanus and diphtheria toxoid vaccine (Tdap. In some countries, pregnant women also receive a vaccine against hepatitis B as well as anti hepatitis A and E. There are also studies on vaccines against the RSV virus and pneumococci. Vaccination is the most effective form of prevention of infectious diseases and their use during pregnancy does not entail any additional risk to the mother or her baby. The benefits of vaccination are huge, so pregnant women should take  recommended vaccination and shouldn’t  be afraid of using them.

  6. A Location-Based Business Information Recommendation Algorithm

    Directory of Open Access Journals (Sweden)

    Shudong Liu

    2015-01-01

    Full Text Available Recently, many researches on information (e.g., POI, ADs recommendation based on location have been done in both research and industry. In this paper, we firstly construct a region-based location graph (RLG, in which region node respectively connects with user node and business information node, and then we propose a location-based recommendation algorithm based on RLG, which can combine with user short-ranged mobility formed by daily activity and long-distance mobility formed by social network ties and sequentially can recommend local business information and long-distance business information to users. Moreover, it can combine user-based collaborative filtering with item-based collaborative filtering, and it can alleviate cold start problem which traditional recommender systems often suffer from. Empirical studies from large-scale real-world data from Yelp demonstrate that our method outperforms other methods on the aspect of recommendation accuracy.

  7. Research on the Application of Persona in Book Recommendation System

    Science.gov (United States)

    Gao, Baozhong; Du, Shouyan; Li, Xinzhi; Liu, Fangai

    2017-10-01

    Currently, there still exists a host of problems in the book recommendation system, such as low accuracy, weak correlation and poor pertinence. Aiming to unravel these problems, this paper based on the theory of big data and data mining technology, through analyzing internet user behavior and the “5C” model of personal credit evaluation, combined with joint impact weight calculation method, which involves user grade, borrowing credit, book friend recommendation degree, book friend recommended adoption degree, borrowing frequency, borrowing number, and borrowing time interval. User activity and credit are also taken into account in the process of establishing user tagging system so as to build classified book recommendation service. This method is of universal meaning to the book recommendation service of smart campus with user as the core under big data environment.

  8. AN EFFECTIVE RECOMMENDATIONS BY DIFFUSION ALGORITHM FOR WEB GRAPH MINING

    Directory of Open Access Journals (Sweden)

    S. Vasukipriya

    2013-04-01

    Full Text Available The information on the World Wide Web grows in an explosive rate. Societies are relying more on the Web for their miscellaneous needs of information. Recommendation systems are active information filtering systems that attempt to present the information items like movies, music, images, books recommendations, tags recommendations, query suggestions, etc., to the users. Various kinds of data bases are used for the recommendations; fundamentally these data bases can be molded in the form of many types of graphs. Aiming at provided that a general framework on effective DR (Recommendations by Diffusion algorithm for web graphs mining. First introduce a novel graph diffusion model based on heat diffusion. This method can be applied to both undirected graphs and directed graphs. Then it shows how to convert different Web data sources into correct graphs in our models.

  9. A Recommendation System to Facilitate Business Process Modeling.

    Science.gov (United States)

    Deng, Shuiguang; Wang, Dongjing; Li, Ying; Cao, Bin; Yin, Jianwei; Wu, Zhaohui; Zhou, Mengchu

    2017-06-01

    This paper presents a system that utilizes process recommendation technology to help design new business processes from scratch in an efficient and accurate way. The proposed system consists of two phases: 1) offline mining and 2) online recommendation. At the first phase, it mines relations among activity nodes from existing processes in repository, and then stores the extracted relations as patterns in a database. At the second phase, it compares the new process under construction with the premined patterns, and recommends proper activity nodes of the most matching patterns to help build a new process. Specifically, there are three different online recommendation strategies in this system. Experiments on both real and synthetic datasets are conducted to compare the proposed approaches with the other state-of-the-art ones, and the results show that the proposed approaches outperform them in terms of accuracy and efficiency.

  10. A fuzzy recommendation system for daily water intake

    Directory of Open Access Journals (Sweden)

    Bin Dai

    2016-05-01

    Full Text Available Water is one of the most important constituents of the human body. Daily consumption of water is thus necessary to protect human health. Daily water consumption is related to several factors such as age, ambient temperature, and degree of physical activity. These factors are generally difficult to express with exact numerical values. The main objective of this article is to build a daily water intake recommendation system using fuzzy methods. This system will use age, physical activity, and ambient temperature as the input factors and daily water intake values as the output factor. The reasoning mechanism of the fuzzy system can calculate the recommended value of daily water intake. Finally, the system will compare the actual recommended values with our system to determine the usefulness. The experimental results show that this recommendation system is effective in actual application.

  11. May I Suggest? Comparing Three PLE Recommender Strategies

    Directory of Open Access Journals (Sweden)

    Felix Mödritscher

    2011-11-01

    Full Text Available Personal learning environment (PLE solutions aim at empowering learners to design (ICT and web-based environments for their learning activities, mashingup content and people and apps for different learning contexts. Widely used in other application areas, recommender systems can be very useful for supporting learners in their PLE-based activities, to help discover relevant content, peers sharing similar learning interests or experts on a specific topic. In this paper we examine the utilization of recommender technology for PLEs. However, being confronted by a variety of educational contexts we present three strategies for providing PLE recommendations to learners. Consequently, we compare these recommender strategies by discussing their strengths and weaknesses in general.

  12. Promoting cold-start items in recommender systems.

    Science.gov (United States)

    Liu, Jin-Hu; Zhou, Tao; Zhang, Zi-Ke; Yang, Zimo; Liu, Chuang; Li, Wei-Min

    2014-01-01

    As one of the major challenges, cold-start problem plagues nearly all recommender systems. In particular, new items will be overlooked, impeding the development of new products online. Given limited resources, how to utilize the knowledge of recommender systems and design efficient marketing strategy for new items is extremely important. In this paper, we convert this ticklish issue into a clear mathematical problem based on a bipartite network representation. Under the most widely used algorithm in real e-commerce recommender systems, the so-called item-based collaborative filtering, we show that to simply push new items to active users is not a good strategy. Interestingly, experiments on real recommender systems indicate that to connect new items with some less active users will statistically yield better performance, namely, these new items will have more chance to appear in other users' recommendation lists. Further analysis suggests that the disassortative nature of recommender systems contributes to such observation. In a word, getting in-depth understanding on recommender systems could pave the way for the owners to popularize their cold-start products with low costs.

  13. Promoting Cold-Start Items in Recommender Systems

    Science.gov (United States)

    Liu, Jin-Hu; Zhou, Tao; Zhang, Zi-Ke; Yang, Zimo; Liu, Chuang; Li, Wei-Min

    2014-01-01

    As one of the major challenges, cold-start problem plagues nearly all recommender systems. In particular, new items will be overlooked, impeding the development of new products online. Given limited resources, how to utilize the knowledge of recommender systems and design efficient marketing strategy for new items is extremely important. In this paper, we convert this ticklish issue into a clear mathematical problem based on a bipartite network representation. Under the most widely used algorithm in real e-commerce recommender systems, the so-called item-based collaborative filtering, we show that to simply push new items to active users is not a good strategy. Interestingly, experiments on real recommender systems indicate that to connect new items with some less active users will statistically yield better performance, namely, these new items will have more chance to appear in other users' recommendation lists. Further analysis suggests that the disassortative nature of recommender systems contributes to such observation. In a word, getting in-depth understanding on recommender systems could pave the way for the owners to popularize their cold-start products with low costs. PMID:25479013

  14. Towards Information Enrichment through Recommendation Sharing

    Science.gov (United States)

    Weng, Li-Tung; Xu, Yue; Li, Yuefeng; Nayak, Richi

    Nowadays most existing recommender systems operate in a single organisational basis, i.e. a recommender system recommends items to customers of one organisation based on the organisation's datasets only. Very often the datasets of a single organisation do not have sufficient resources to be used to generate quality recommendations. Therefore, it would be beneficial if recommender systems of different organisations with similar nature can cooperate together to share their resources and recommendations. In this chapter, we present an Ecommerce-oriented Distributed Recommender System (EDRS) that consists of multiple recommender systems from different organisations. By sharing resources and recommendations with each other, these recommenders in the distributed recommendation system can provide better recommendation service to their users. As for most of the distributed systems, peer selection is often an important aspect. This chapter also presents a recommender selection technique for the proposed EDRS, and it selects and profiles recommenders based on their stability, average performance and selection frequency. Based on our experiments, it is shown that recommenders' recommendation quality can be effectively improved by adopting the proposed EDRS and the associated peer selection technique.

  15. Chest tuberculosis: Radiological review and imaging recommendations

    International Nuclear Information System (INIS)

    Bhalla, Ashu Seith; Goyal, Ankur; Guleria, Randeep; Gupta, Arun Kumar

    2015-01-01

    Chest tuberculosis (CTB) is a widespread problem, especially in our country where it is one of the leading causes of mortality. The article reviews the imaging findings in CTB on various modalities. We also attempt to categorize the findings into those definitive for active TB, indeterminate for disease activity, and those indicating healed TB. Though various radiological modalities are widely used in evaluation of such patients, no imaging guidelines exist for the use of these modalities in diagnosis and follow-up. Consequently, imaging is not optimally utilized and patients are often unnecessarily subjected to repeated CT examinations, which is undesirable. Based on the available literature and our experience, we propose certain recommendations delineating the role of imaging in the diagnosis and follow-up of such patients. The authors recognize that this is an evolving field and there may be future revisions depending on emergence of new evidence

  16. [Nutrition recommendations for children who practice sports].

    Science.gov (United States)

    Sánchez-Valverde Visus, F; Moráis López, A; Ibáñez, J; Dalmau Serra, J

    2014-08-01

    Several health benefits have been attributed to sports practice, and an adequate nutrition status helps to maintain an optimal performance. Children most frequently practice non-competitive and non-endurance activities in a school setting. The dietary intake of children who practice sports should be similar to the general population, properly meeting their energy and nutrient requirements. During the activity performance, correct hydration should be aimed for, with water appearing to be an adequate source in most cases. General calorie and micronutrient supplementation should not be commonly recommended in children. Paediatricians must control nutritional status and dietary habits of children who practice sports, especially in those cases when weight-loss is aimed for, as well as take into account the psychological implications of competitive sports practice. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  17. Dietetic recommendations in rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    María Rosa Alhambra-Expósito

    2013-12-01

    Full Text Available Rheumatoid arthritis (RA is a chronic autoimmune disease that has a significant effect on patients’ physical, emotional, and social functioning. For decades, patients have used different diets to try to improve the symptoms of RA. The possible benefits of dietary therapy for rheumatoid arthritis are reviewed in this article. Nutritional objectives for RA, are to halt the loss of bone mass, promote healing of bone fractures and improving bone-associated inflammatory disorders and joints. In general, diets low in saturated fat, rich in polyunsaturated fats: omega 3 and omega 6, rich in complex carbohydrates and fiber are recommended.

  18. Vaccination recommended for pregnant women

    OpenAIRE

    Skolarczyk, Justyna; Łabądź, Dawid; Pekar, Joanna; Nieradko-Iwanicka, Barbara

    2017-01-01

    Skolarczyk Justyna, Łabądź Dawid, Pekar Joanna, Nieradko-Iwanicka Barbara. Vaccination recommended for pregnant women. Journal of Education, Health and Sport. 2017;7(4):682-688. eISSN 2391-8306. DOI http://dx.doi.org/10.5281/zenodo.569050 http://ojs.ukw.edu.pl/index.php/johs/article/view/4423 The journal has had 7 points in Ministry of Science and Higher Education parametric evaluation. Part B item 1223 (26.01.2017). 1223 Journal of Education, Health and Sport eI...

  19. ExpertFOAF recommends experts

    DEFF Research Database (Denmark)

    Iofcu, Tereza; Diederich, Joerg; Dolog, Peter

    2007-01-01

    FOAF files are often used for publishing simple information about persons and about their community. Our proposal is to extend the user's FOAF files with automatically generated user profiles, which are based on a histogram of the user's interest and which are also semantically enriched using...... recommender systems for finding users with similar interests and, hence, expertise in different domains. We consider a well-defined user profile to express best the user's current interests in a domain, where the domain (such as the research environment with students and professors) is defined by a collection...

  20. Physical Exercise and MS Recommendations

    DEFF Research Database (Denmark)

    Dalgas, U; Ingemann-Hansen, T; Stenager, E

    2009-01-01

    in a number of physiological functions, which ultimately can lead to functional improvements that have a positive effect on a patients daily life. The purpose of this review is, based on the existing research, to provide clinicians with some easily administrable recommendations for the application of exercise......The use of physical exercise programmes in the rehabilitation of patients with multiple sclerosis (MS) has been a controversial issue for many years. During the last decade, however, evidence from a number of studies has suggested that exercise is a safe and efficient way to induce improvements...

  1. Hybrid employment recommendation algorithm based on Spark

    Science.gov (United States)

    Li, Zuoquan; Lin, Yubei; Zhang, Xingming

    2017-08-01

    Aiming at the real-time application of collaborative filtering employment recommendation algorithm (CF), a clustering collaborative filtering recommendation algorithm (CCF) is developed, which applies hierarchical clustering to CF and narrows the query range of neighbour items. In addition, to solve the cold-start problem of content-based recommendation algorithm (CB), a content-based algorithm with users’ information (CBUI) is introduced for job recommendation. Furthermore, a hybrid recommendation algorithm (HRA) which combines CCF and CBUI algorithms is proposed, and implemented on Spark platform. The experimental results show that HRA can overcome the problems of cold start and data sparsity, and achieve good recommendation accuracy and scalability for employment recommendation.

  2. Recommender systems in knowledge-mining

    Science.gov (United States)

    Volna, Eva

    2017-07-01

    The subject of the paper is to analyse the possibilities of application of recommender systems in the field of data mining. The work focuses on three basic types of recommender systems (collaborative, content-based and hybrid). The goal of the article is to evaluate which of these three concepts of recommender systems provides forecast with the lowest error rate in the domain of recommending movies. This target is fulfilled by the practical part of the work - at first, the own recommender system was designed and created, capable of obtaining movies recommendation from the database based on the user's preferences. Next, we verified experimentally which recommender system produces more accurate results.

  3. Competition protection and Philip Kotler’s strategic recommendations

    OpenAIRE

    Fornalczyk, Anna

    2011-01-01

    P. Kotler’s recommendations of modern marketing tell managers how to achieve and maintain a dominant market position. Some of the recommended activities may, however, infringe European and Polish competition law. Objections are not raised by market success achieved as a result of high product quality, good customer care, high market shares, continuous product improvements, new product release, entry onto fast growing markets, and exceeding customer expectations. Competition law...

  4. Research on Long Tail Recommendation Algorithm

    Science.gov (United States)

    Hu, Xuezhi; Zhang, Chuang; Wu, Ming; Zeng, Yang

    2017-10-01

    Most recommendation systems in the major electronic commerce platforms are influenced by the long tail effect more or less. There are sufficient researches of how to assess recommendation effect while no criteria to evaluate long tail recommendation rate. In this study, we first discussed the existing problems of recommending long tail products through specific experiments. Then we proposed a long tail evaluation criteria and compared the performance in long tail recommendation between different models.

  5. Recommended system of application and development

    Science.gov (United States)

    Wang, Wei

    2018-04-01

    A recommender system is a project that helps users identify their wishes and needs. The recommender system has been successfully applied to many e-commerce environments, such as news, film, music, books and other areas of recommendation. This paper mainly discusses the application of recommendation technology in software engineering, data and knowledge engineering, configurable projects and persuasion technology, and summarizes the development trend of recommendation technology in the future.

  6. Ransomware - Threats Vulnerabilities And Recommendations

    Directory of Open Access Journals (Sweden)

    Nadeem Shah

    2017-06-01

    Full Text Available Attack methodologies transform with the transforming dynamics of technology. Consequently it becomes imperative that individuals and organization implement the highest levels of security within their devices and infrastructure for optimal protection against these rapidly evolving attacks. Ransomware is one such attack that never fails to surprise in terms of its ability to identify vulnerabilities and loopholes in technology. This paper discusses the categories of ransomware its common attack vectors and provides a threat landscape with the aim to highlight the true potential and destructive nature of such malware based attacks. In this paper we also present the most current ransomware attack that is still a potential threat and also provide recommendations and strategies for prevention and protection against these attacks. A novel solution is also discussed that could be further worked upon in the future by other researchers and vendors of security devices.

  7. Summary, analysis, and policy recommendations

    International Nuclear Information System (INIS)

    Anon.

    1990-01-01

    Four policy recommendations are presented that would provide the foundations for a long-term transportation policy for the US while gradually reducing the threats from petroleum-powered vehicles to the climate and air quality. They include: improvements in new-vehicle fuel efficiency; increased transportation system efficiency; development of non-fossil energy sources for transportation; and reduction of other greenhouse gas emissions. In the future, manufacturers will be under pressure to develop petroleum-powered vehicles that are cleaner, safer, and more fuel efficient; at the same time, they will need to develop new kinds of vehicles that will emit no pollutants. This pressure will come not from market forces but from public policy and will require large amounts of capital

  8. A heterogeneous graph-based recommendation simulator

    Energy Technology Data Exchange (ETDEWEB)

    Yeonchan, Ahn [Seoul National University; Sungchan, Park [Seoul National University; Lee, Matt Sangkeun [ORNL; Sang-goo, Lee [Seoul National University

    2013-01-01

    Heterogeneous graph-based recommendation frameworks have flexibility in that they can incorporate various recommendation algorithms and various kinds of information to produce better results. In this demonstration, we present a heterogeneous graph-based recommendation simulator which enables participants to experience the flexibility of a heterogeneous graph-based recommendation method. With our system, participants can simulate various recommendation semantics by expressing the semantics via meaningful paths like User Movie User Movie. The simulator then returns the recommendation results on the fly based on the user-customized semantics using a fast Monte Carlo algorithm.

  9. Extending a Hybrid Tag-Based Recommender System with Personalization

    DEFF Research Database (Denmark)

    Durao, Frederico; Dolog, Peter

    2010-01-01

    extension for a hybrid tag-based recommender system, which suggests similar Web pages based on the similarity of their tags. The semantic extension aims at discovering tag relations which are not considered in basic syntax similarity. With the goal of generating more semantically grounded recommendations......, the proposal extends a hybrid tag-based recommender system with a semantic factor, which looks for tag relations in different semantic sources. In order to evaluate the benefits acquired with the semantic extension, we have compared the new findings with results from a previous experiment involving 38 people......Tagging activity has been recently identified as a potential source of knowledge about personal interests, preferences, goals, and other attributes known from user models. Tags themselves can be therefore used for finding personalized recommendations of items. This paper proposes a semantic...

  10. Operating characteristics of a partial-block randomized crossover bioequivalence study for dutasteride, a drug with a long half-life: investigation through simulation and comparison with final results.

    Science.gov (United States)

    Cai, Gengqian; Thiessen, Jake J; Baidoo, Charlotte A; Fossler, Michael J

    2010-10-01

    Studies to establish bioequivalence (BE) of a drug are important elements in support of drug applications. A typical BE study is conducted as a single dose, randomized, 2-period crossover design. For drugs with long half lives (≥ 48 hours) and evaluation of multiple BE objectives in 1 trial, this design may not be adequate. A parallel design may then be a more appropriate choice. However, parallel designs require increased sample size, which can become substantial. One option that is a compromise between the complete randomized block design and the parallel design is a partial-block crossover design. This approach came about during the development of a combination of dutasteride and tamsulosin. Previous experience with performing single-dose dutasteride studies suggested that 28 days of washout is needed between treatments because of its half-life of 7-9 days. Simulations were performed to assess the operating characteristics of this design using a previously developed PK model. Four scenarios were developed, and each scenario was simulated 500 times. The results showed that this design demonstrated acceptable consumer and producer risk. Partial-block crossover designs should be considered for studies when the half-life of the drug is long and there are more than 2 periods.

  11. Three-way, three-period, crossover bioequivalence study of single oral dose of three brands of 300 mg phenytoin sodium tablets marketed in India, on healthy Indian human volunteers.

    Science.gov (United States)

    Doshi, Maulik S; Naik, Anuja A; Mehta, Mohit R; Gogtay, Nithya J; Thatte, Urmila M; Menon, Mala D

    2013-10-01

    To compare the bioavailability of two brands of phenytoin sodium tablets available in the Indian market using Eptoin™ as the reference. A randomized, assessor-blind, three-way crossover design study was carried out over a period of 6 months after approval from the Institutional Review Board (IRB). Twenty-two healthy male participants received a single oral 300 mg oral tablet of either of the formulations with a 2-week washout. Blood samples were collected predose and at regular intervals postdose. Plasma phenytoin levels were estimated by high-performance liquid chromatography. Calculation of Cmax, AUC0-t, and AUC0-∞ was done by the linear trapezoidal rule and 90-110% margin (90% confidence interval (CI)) was used to assess bioequivalence. Twenty volunteers completed the study. It was seen that the log-transformed values of Cmax, AUC0-t, and AUC0-∞ of the test formulations were not within the specified limits. Bioinequivalence of available phenytoin brands indicates that switching brands could lead to variations in blood concentrations and thus impact safety and efficacy. If a brand switch is done for any reason, stringent drug-level monitoring is advised.

  12. Recommendable Practices for Effective Nuclear Crisis Communication

    International Nuclear Information System (INIS)

    Lee, Chang Ju; Hah, Yeon Hee

    2011-01-01

    'Crisis communication' refers one of the activities done by the Nuclear Regulatory Organizations (NROs) in order to protect the public and the environment from the possible harmful effects. As denoted by the BMU, German NRO, crisis communication is not only 'public information' or 'information for the public', but also communication between authorities in order to guarantee that public information is consistent. This study proposes some recommendable practices for developing a guideline of well-prepared nuclear crisis communication system, including its management framework, and for introducing good insights, based on the study of international aspects provided by relevant OECD/NEA WPGC (Working Group on Public Communication for Nuclear Regulatory Organizations)i working group

  13. [Recommendations for the prevention of drowning].

    Science.gov (United States)

    Rubio, B; Yagüe, F; Benítez, M T; Esparza, M J; González, J C; Sánchez, F; Vila, J J; Mintegi, S

    2015-01-01

    Drowning is the second leading cause of non-intentional death in children under the age of 19 in Europe. Weather conditions in Spain allow an extended period of contact with water, therefore increasing the risk of drowning (due to the increased exposure), and constitutes the second leading cause of accidental death in children less than 14 years of age. In children younger than 5 years, drowning occurs mostly in pools belonging to private homes or communities, while in older children, drowning is often linked to aquatic recreational activities in lakes, sea, rivers and canals, and at times associated with alcohol consumption. In this article, the Committee on Safety and Non-Intentional Injury Prevention in Childhood of the Spanish Association of Pediatrics provides a series of architectonic, educational and legislative recommendations to prevent such incidents. Copyright © 2014 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  14. Recommendations of the NNCSC-BNL study

    International Nuclear Information System (INIS)

    1976-01-01

    In 1975 the National Neutron Cross Section Center (NNCSC) at BNL was asked to carry out a study of the nuclear structure and charged-particle reaction data compilation and evaluation efforts in the U. S. with a view toward establishing at NNCSC responsibility for a fully coordinated effort involving measurers, compilers, evaluators, and users whose activities would result in the creation and maintenance of a master file for nuclear structure and charged-particle reaction data. A critique of this study was made by the Ad Hoc Panel on Basic Nuclear Data Compilations; this critique is presented here. The Panel recommended the establishment of a standing panel to monitor and advise on the implementation of the proposed new organizational arrangement for carrying out basic data compilations

  15. FAVL work group: report and recommendations

    International Nuclear Information System (INIS)

    2011-01-01

    This document reports the works of a work group dedicated to the process of search for storage site for low activity and long life radioactive wastes. The authors recall the history of this process which started in the early 1990's, and resulted in the selection of two sites, in Auxon and in Pars-les-Chavanges, and finally in the withdrawal of both towns. Then, the authors analyse the whole process in terms of intervention or participation of local authorities, of information and participation of waste producers. They also discuss the roles of the ASN, IRSN, DGEC, ANDRA and ANDRA's Coesdic. They make recommendations regarding site selection, agenda, responsibilities, preferential representative at the local level, public information, consultation, and project support

  16. Recommender Systems in Technology Enhanced Learning

    NARCIS (Netherlands)

    Manouselis, Nikos; Drachsler, Hendrik; Vuorikari, Riina; Hummel, Hans; Koper, Rob

    2010-01-01

    Manouselis, N., Drachsler, H., Vuorikari, R., Hummel, H. G. K., & Koper, R. (2011). Recommender Systems in Technology Enhanced Learning. In P. B. Kantor, F. Ricci, L. Rokach, & B. Shapira (Eds.), Recommender Systems Handbook (pp. 387-415). Berlin: Springer.

  17. Preventive Care Recommendations for Adults with MS

    Science.gov (United States)

    ... risk factors including prolonged use of steroids or anticonvulsants, a family history of osteoporosis, and a sedentary ... care provider. Yearly. Monthly. The American Academy of Pediatrics recommends starting at age eighteen. Preventive Care Recommendations | ...

  18. Great Explanations: Opinionated Explanations for Recommendation

    OpenAIRE

    Muhammad, Khalil; Lawlor, Aonghus; Rafter, Rachael; Smyth, Barry

    2015-01-01

    Explaining recommendations helps users to make better, more satisfying decisions. We describe a novel approach to explanation for recommender systems, one that drives the recommendation process, while at the same time providing the user with useful insights into the reason why items have been chosen and the trade-os they may need to consider when making their choice. We describe this approach in the context ofa case-based recommender system that harnesses opinions mined from user-generated re...

  19. Recommendation System Based on Fuzzy Cognitive Map

    OpenAIRE

    Wei Liu; Linzhi Gao

    2014-01-01

    With the increase of data volume and visitor volume, the website faces great challenge in the environment of network. How to know the users’ requirements rapidly and effectively and recommend the required information to the user becomes the research direction of all websites. The researchers of recommendation system propose a series of recommendation system models and algorithms for the user. The common challenge faced by these algorithms is how to judge the user intention and recommend...

  20. Permian Basin location recommendation report

    International Nuclear Information System (INIS)

    1983-09-01

    Candidate study areas are screened from the Palo Duro and Dalhart Basin areas using data obtained from studies to date and criteria and specifications that consider: rock geometry; rock characteristics; human intrusion potential; surface characteristics; and environmental and socioeconomic conditions. Two preferred locations are recommended from among these areas for additional characterization to identify potential National Waste Terminal Storage (NWTS) salt repository sites. One location, in northeastern Deaf Smith County and southeastern Oldham County, is underlain by two salt units that meet the adopted screening specifications. The other location, in northcentral Swisher County, is underlain by one salt unit that meets the adopted screening specifications. Both locations have several favorable features, relative to surrounding areas, and no obviously undesirable characteristics. Both lie wholly on the Southern High Plains surface, are in relatively sparsely populated areas, contain no unique land use conflicts, and comprise large enough geographic areas to provide flexibility in site selection. Data gathered to date indicate that these locations contain salt units sufficient in thickness and in depth for the safe construction and operation of the underground facilities under consideration. 93 references, 34 figures, 6 tables

  1. Epilepsy surgery: Recommendations for India

    Directory of Open Access Journals (Sweden)

    Chandra P

    2010-01-01

    Full Text Available The following article recommends guidelines for epilepsy surgery for India. This article reviews the indications, the various surgical options available and the outcome of surgery for drug resistant epilepsy based on current evidence. Epilepsy surgery is a well-established option for patients who have been diagnosed to have drug resistant epilepsy (DRE (on at least two appropriate, adequate anti-epileptic drugs (AEDs (either in monotherapy or in combination with continuing seizures, where the presurgical work-up has shown concordance of structural imaging (magnetic resonance imaging and electrical mapping data (electroencephalography (EEG, video EEG. There may be a requirement of functional imaging techniques in a certain number of DRE like positron emission tomography (PET, single photon emission tomography, (SPECT. Invasive monitoring should be restricted to a few when all noninvasive investigations are inconclusive, there is a dual pathology or there is a discordance of noninvasive data. The types of surgery could be curative (resective surgeries: amygdalo hippocampectomy, lesionectomy and multilobar resections; functional surgeries: hemispherotomy and palliative (multiple subpial transaction, corpus callosotomy, vagal nerve stimulation. Epilepsy surgery in indicated cases has a success range from 50 to 86% in achieving seizure freedom as compared with < 5% success rate with AEDs only in persons with DRE. Centers performing surgery should be categorized into Level I and Level II.

  2. Epilepsy and recommendations for breastfeeding.

    Science.gov (United States)

    Veiby, Gyri; Bjørk, Marte; Engelsen, Bernt A; Gilhus, Nils Erik

    2015-05-01

    The objective of this paper is to provide a synopsis of benefits and potential harmful effects of exposure to antiepileptic drugs (AEDs) via breastmilk, and present recommendations for breastfeeding in women with epilepsy. The article is based on a discretionary selection of English language articles retrieved by a literature search in the PubMed database, the LactMed database, and the authors' clinical experience. Breastfeeding is associated with benefits for the infant, including nutrition, protection against infectious and immunological disease, and promotion of development and psychological attachment. Exposure to AEDs via breastmilk could potentially produce side effects or negatively affect development. Most studies on AED transfer through breastmilk report infant serum levels well below the limit of an expected pharmacological effect. Some drugs have the potential to reach significant serum levels in breastfed infants, such as barbiturates, benzodiazepines, lamotrigine, and ethosuximide. Thus, breastfed infants should be monitored for side effects. Still, adverse symptoms are rarely reported in breastfed infants of mothers taking AEDs, and prospective studies have failed to demonstrate any negative developmental effects in children that have been exposed to AEDs via breastmilk. The nursing infant's degree of drug exposure can be minimized by breastfeeding when drug concentrations in the milk are low, reducing maternal AED dosage to prepregnancy levels, and administering mixed nutrition. Most AEDs are considered safe or moderately safe during breastfeeding. Mothers with epilepsy should be encouraged to breastfeed, provided careful monitoring of the infant. Copyright © 2015 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  3. Decision-Guided Recommenders with Composite Alternatives

    Science.gov (United States)

    Alodhaibi, Khalid

    2011-01-01

    Recommender systems aim to support users in their decision-making process while interacting with large information spaces and recommend items of interest to users based on preferences they have expressed, either explicitly or implicitly. Recommender systems are increasingly used with product and service selection over the Internet. Although…

  4. Panorama of Recommender Systems to Support Learning

    NARCIS (Netherlands)

    Drachsler, Hendrik; Verbert, Katrien; Santos, Olga C.; Manouselis, Nikos

    2015-01-01

    This chapter presents an analysis of recommender systems in TechnologyEnhanced Learning along their 15 years existence (2000-2014). All recommender systems considered for the review aim to support educational stakeholders by personalising the learning process. In this meta-review 82 recommender

  5. Explaining the user experience of recommender systems

    NARCIS (Netherlands)

    Knijnenburg, B.P.; Willemsen, M.C.; Gantner, Z.; Soncu, H.; Newell, C.

    2012-01-01

    Research on recommender systems typically focuses on the accuracy of prediction algorithms. Because accuracy only partially constitutes the user experience of a recommender system, this paper proposes a framework that takes a user-centric approach to recommender system evaluation. The framework

  6. Paired analyst recommendations and internet IPOs

    NARCIS (Netherlands)

    van der Goot, T.; van Giersbergen, N.

    2008-01-01

    The paper investigates analyst recommendations for internet firms that went public during 1997-2000. Our contribution to the literature is that we match recommendations for the same firm issued by different investment banks that have published the recommendations in an interval around the same date.

  7. Cryptographically-Enhanced Privacy for Recommender Systems

    NARCIS (Netherlands)

    Jeckmans, Arjan

    2014-01-01

    Automated recommender systems are used to help people find interesting content or persons in the vast amount of information available via the internet. There are different types of recommender systems, for example collaborative filtering systems and content-based recommender systems. However, all

  8. Toward Privacy-Preserving Personalized Recommendation Services

    Directory of Open Access Journals (Sweden)

    Cong Wang

    2018-02-01

    Full Text Available Recommendation systems are crucially important for the delivery of personalized services to users. With personalized recommendation services, users can enjoy a variety of targeted recommendations such as movies, books, ads, restaurants, and more. In addition, personalized recommendation services have become extremely effective revenue drivers for online business. Despite the great benefits, deploying personalized recommendation services typically requires the collection of users’ personal data for processing and analytics, which undesirably makes users susceptible to serious privacy violation issues. Therefore, it is of paramount importance to develop practical privacy-preserving techniques to maintain the intelligence of personalized recommendation services while respecting user privacy. In this paper, we provide a comprehensive survey of the literature related to personalized recommendation services with privacy protection. We present the general architecture of personalized recommendation systems, the privacy issues therein, and existing works that focus on privacy-preserving personalized recommendation services. We classify the existing works according to their underlying techniques for personalized recommendation and privacy protection, and thoroughly discuss and compare their merits and demerits, especially in terms of privacy and recommendation accuracy. We also identity some future research directions. Keywords: Privacy protection, Personalized recommendation services, Targeted delivery, Collaborative filtering, Machine learning

  9. Preference-Based Recommendations for OLAP Analysis

    Science.gov (United States)

    Jerbi, Houssem; Ravat, Franck; Teste, Olivier; Zurfluh, Gilles

    This paper presents a framework for integrating OLAP and recommendations. We focus on the anticipatory recommendation process that assists the user during his OLAP analysis by proposing to him the forthcoming analysis step. We present a context-aware preference model that matches decision-makers intuition, and we discuss a preference-based approach for generating personalized recommendations.

  10. [The Results of Self-Assessment by Medical Organizations Their Correspondence to Proposals (Practical Recommendations) of the Roszdravnadzor Concerning Organization of Internal Control of Quality and Safety of Medical Activity].

    Science.gov (United States)

    Ivanov, I V; Shvabsky, O R; Minulin, I B

    2017-11-01

    The article presents the analysis of the results of internal audits (self-rating) in medical organizations implemented on the basis of Proposals (practical guidelines) of the Roszdravnadzor concerning organization of inner control of quality and safety of medical activities in medical organization (hospital). The self-rating was implemented by the medical organizations themselves according the common criteria of the Proposals as provided the following plan: planning of self-rating, collection and processing of data, application of self-rating, analysis of obtained results, preparation of report. The article uses the results of self-rating of medical organizations corresponding to following criteria: profile of activity-multi-field hospital-number of beds more than 350-state property. The self-rating was implemented according to 11 basic parts of the Proposals. The criteria were developed for every part. The evaluation lists developed on the basis of the given Proposals permitted to medical organizations to independently establish problems in their activities. Within the framework of implemented self-rating medical organizations mentioned the directions of activity related to personnel management, identification of personality of patient, support of epidemiological and surgical safety as having significant discrepancies with the Proposals and requiring implementation of improvement measures.

  11. A Study on Recommendation Systems in Location Based Social Networking

    Directory of Open Access Journals (Sweden)

    Ranganath Ashok Kumar

    2017-01-01

    Full Text Available Smart devices in the hands of people are revolutionizing the social lifestyle of one's self. Everyone across the world are using smart devices linked to their social networking activities one such activity is to share location data by uploading the tagged media content like photos, videos. The data is of surroundings, events attended/attending and travel experiences. Users share their experiences at a given location through localization techniques. Using such data from social networks an attempt is made to analyse tagged media content to acquire information on user context, individual’s interests, tastes, behaviours and derive meaningful relationships amongst them are referred to as Location Based Social Networks (LBSNs. The resulting information can be used to market a product and to improve business, as well recommend a travel and plan an itinerary. This paper presents a comprehensive survey of recommended systems for LBSNs covering the concepts of LBSNs, terminologies of LBSN and various recommendation systems.

  12. Canadian solar export market study. Export policy recommendations

    Energy Technology Data Exchange (ETDEWEB)

    1983-11-01

    This report outlines policies and recommendations on the export of Canadian solar equipment and technology, with a view toward stimulating the domestic solar industry. The current picture is of an industry which is relatively small, operates in a competitive domestic market with low profit margins, and needs assistance in order to break into the world market. A number of recommendations are therefore made on the main thrust of industry and government solar export development activities. An export development program is described which includes a strategy of concentrating on a limited number of product lines, namely: low-temperature solar heating systems for recreational applications, integrated residential water heating systems, prepackaged commercial water heating systems, and industrial pre-heat systems. It is also recommended that this strategy be directed only at a limited number of target countries where the market justifies such activity. Market research, international cooperation agreements, promotional services, and proper export organization are also needed.

  13. Active microwave remote sensing research program plan. Recommendations of the Earth Resources Synthetic Aperture Radar Task Force. [application areas: vegetation canopies, surface water, surface morphology, rocks and soils, and man-made structures

    Science.gov (United States)

    1980-01-01

    A research program plan developed by the Office of Space and Terrestrial Applications to provide guidelines for a concentrated effort to improve the understanding of the measurement capabilities of active microwave imaging sensors, and to define the role of such sensors in future Earth observations programs is outlined. The focus of the planned activities is on renewable and non-renewable resources. Five general application areas are addressed: (1) vegetation canopies, (2) surface water, (3) surface morphology, (4) rocks and soils, and (5) man-made structures. Research tasks are described which, when accomplished, will clearly establish the measurement capabilities in each area, and provide the theoretical and empirical results needed to specify and justify satellite systems using imaging radar sensors for global observations.

  14. Measuring Physical Activity Intensity

    Medline Plus

    Full Text Available ... Physical Activity, 2014 Recommendations & Guidelines Fact Sheets & Infographics Social Media Tools Community Strategies BE Active: Connecting Routes + ... Obesity , National Center for Chronic Disease Prevention and Health Promotion Email Recommend Tweet YouTube Instagram Listen Watch ...

  15. An Agent Framework of Tourism Recommender System

    Directory of Open Access Journals (Sweden)

    Jia Zhi Yang

    2016-01-01

    Full Text Available This paper proposes the development of an Agent framework for tourism recommender system. The recommender system can be featured as an online web application which is capable of generating a personalized list of preference attractions for tourists. Traditional technologies of classical recommender system application domains, such as collaborative filtering, content-based filtering and content-based filtering are effectively adopted in the framework. In the framework they are constructed as Agents that can generate recommendations respectively. Recommender Agent can generate recommender information by integrating the recommendations of Content-based Agent, collaborative filtering-based Agent and constraint-based Agent. In order to make the performance more effective, linear combination method of data fusion is applied. User interface is provided by the tourist Agent in form of webpages and mobile app.

  16. The Definition of Novelty in Recommendation System

    Directory of Open Access Journals (Sweden)

    Liang Zhang

    2013-01-01

    Full Text Available With the development of information technology and application of the Internet, People gradually entered the time of information overload from information scarcity. User satisfaction with recommender systems is related not only to how accurately the system recommends but also to how much it supports the user’s decision making. Novelty is one of the important metrics of customer satisfaction. There is an increasing realization in the Recommender Systems (RS field that novelty is fundamental qualities of recommendation effectiveness and added-value. This paper combed research results about definition and algorithm of novel recommendation, and starting from the meaning of "novel", defined novelty of item in recommendation system. Experiment proved using the definition of novelty to recommend can effectively recognize the item that the user is familiar with and ensure certain accuracy.

  17. Defining and Supporting Narrative-driven Recommendation

    DEFF Research Database (Denmark)

    Bogers, Toine; Koolen, Marijn

    2017-01-01

    Research into recommendation algorithms has made great strides in recent years. However, these algorithms are typically applied in relatively straightforward scenarios: given information about a user's past preferences, what will they like in the future? Recommendation is often more complex......: evaluating recommended items never takes place in a vacuum, and it is often a single step in the user's more complex background task. In this paper, we define a specific type of recommendation scenario called narrative-driven recommendation, where the recommendation process is driven by both a log...... of the user's past transactions as well as a narrative description of their current interest(s). Through an analysis of a set of real-world recommendation narratives from the LibraryThing forums, we demonstrate the uniqueness and richness of this scenario and highlight common patterns and properties...

  18. Hybrid recommendation methods in complex networks.

    Science.gov (United States)

    Fiasconaro, A; Tumminello, M; Nicosia, V; Latora, V; Mantegna, R N

    2015-07-01

    We propose two recommendation methods, based on the appropriate normalization of already existing similarity measures, and on the convex combination of the recommendation scores derived from similarity between users and between objects. We validate the proposed measures on three data sets, and we compare the performance of our methods to other recommendation systems recently proposed in the literature. We show that the proposed similarity measures allow us to attain an improvement of performances of up to 20% with respect to existing nonparametric methods, and that the accuracy of a recommendation can vary widely from one specific bipartite network to another, which suggests that a careful choice of the most suitable method is highly relevant for an effective recommendation on a given system. Finally, we study how an increasing presence of random links in the network affects the recommendation scores, finding that one of the two recommendation algorithms introduced here can systematically outperform the others in noisy data sets.

  19. A general framework for intelligent recommender systems

    Directory of Open Access Journals (Sweden)

    Jose Aguilar

    2017-07-01

    Full Text Available In this paper, we propose a general framework for an intelligent recommender system that extends the concept of a knowledge-based recommender system. The intelligent recommender system exploits knowledge, learns, discovers new information, infers preferences and criticisms, among other things. For that, the framework of an intelligent recommender system is defined by the following components: knowledge representation paradigm, learning methods, and reasoning mechanisms. Additionally, it has five knowledge models about the different aspects that we can consider during a recommendation: users, items, domain, context and criticisms. The mix of the components exploits the knowledge, updates it and infers, among other things. In this work, we implement one intelligent recommender system based on this framework, using Fuzzy Cognitive Maps (FCMs. Next, we test the performance of the intelligent recommender system with specialized criteria linked to the utilization of the knowledge in order to test the versatility and performance of the framework.

  20. Global Advisory Group: conclusions and recommendations.

    Science.gov (United States)

    1986-02-01

    The conclusions and recommendations formulated for the global program by the 8th meeting of the Expanded Program on Immunization (EPI) Global Advisory Group, which took place during November 1985, are summarized. The Global Advisory Group recommends that, in furtherance of the Five-Point Action Program endorsed by the World Health Assembly in 1983, 3 general and 4 specific actions be taken by national immunization programs with the support of the World Health Organization (WHO) to accelerate EPI progress. These recommendations reflect optimism that the 1990 goal of reducing morbidity and mortality by providing immunization for all children of the world can be realized but also acknowledge that many fundamental problems of national program management remain to be resolved. The general actions are: to promote the achievement of the 1990 immunization goal at national and international levels through collaboration among ministries, organizations, and individuals in both the public and private sectors; to adopt a mix of complementary strategies for program acceleration; and to ensure that rapid increases in coverage can be sustained through mechanisms which strengthen th delivery of other primary health care interventions. The specific actions are as follows: to provide immunization at every contact point; to reduce dropout rates between 1st and last immunizations; to improve immunization services to the disadvantaged in urban areas; and to increase priority for the control of measles, poliomyelitis, and neonatal tetanus. The WHO and the UN International Children's Emergency Fund (UNICEF) have collaborated in support of the EPI since the early days of the program. The acceleration of national efforts heightens the importance of this collaboration, particularly at the national level. It may be further facilitated by the provision of policy guidance from global and regional levels, by WHO and UNICEF collaborative agreements at the regional level, and by country agreements

  1. May I Suggest? Comparing Three PLE Recommender Strategies

    Science.gov (United States)

    Modritscher, Felix; Krumay, Barbara; El Helou, Sandy; Gillet, Denis; Nussbaumer, Alexander; Albert, Dietrich; Dahn, Ingo; Ullrich, Carsten

    2011-01-01

    Personal learning environment (PLE) solutions aim at empowering learners to design (ICT and web-based) environments for their learning activities, mashing-up content and people and apps for different learning contexts. Widely used in other application areas, recommender systems can be very useful for supporting learners in their PLE-based…

  2. Recommender Systems for Technology Enhanced Learning: Research Trends & Applications

    NARCIS (Netherlands)

    Manouselis, Nikos; Verbert, Katrien; Drachsler, Hendrik; Santos, Olga

    2014-01-01

    As an area, Technology Enhanced Learning (TEL) aims to design, develop and test socio-technical innovations that will support and enhance learning practices of individuals and organizations. Information retrieval is a pivotal activity in TEL and the deployment of recommender systems has attracted

  3. Look who is talking now: analyst recommendations and internet IPOs

    NARCIS (Netherlands)

    van der Goot, T.; van Giersbergen, N.

    2009-01-01

    This paper investigates whether analyst recommendations are independent of their employer’s investment banking activities. Our sample consists of internet firms that went public during 1997-2000. The contribution of the paper to the literature is threefold. First, to account for missing

  4. Synthetic Sling Failure - Evaluations and Recommendations

    Energy Technology Data Exchange (ETDEWEB)

    Henderson, C. S. [Washington River Protection Solutions, Richland, WA (United States); Mackey, Thomas C. [Washington River Protection Solutions, Richland, WA (United States)

    2009-10-26

    The information and evaluations provided in this report were compiled to address the recurring problem of synthetic sling failure. As safety is the number one priority in all work aspects, a solution must be devised to prevent accidents from occurring. A total of thirteen cases regarding synthetic sling failure were evaluated in order to determine their causes, effects, and preventative measures. From the collected data, it was found that all cases in which the synthetic sling contacted the edge of its load resulted in sling failure. It is required that adequate synthetic sling protection devices be used to protect slings in any lift where the sling comes in direct contact with the edge or corner of its load. However, there are no consensus codes or standards stating the type, material, or purpose of the type of protective device used to protect the sling from being cut. Numerous industry standards and codes provide vague descriptions on how to protect synthetic slings. Without a clear, concise statement of how to protect synthetic slings, it is common for inadequate materials and sling protection devices to be used in an attempt to meet the intent of these requirements. The use of an inadequate sling protection device is the main cause of synthetic sling failure in all researched cases. Commercial sling protection devices come in many shapes and sizes, and have a variety of names, as well as advertised uses. 'Abrasion pads' and 'wear protectors' are two different names for products with the same intended purpose. There is no distinguishable way to determine the extent of sling protection which these devices will provide, or what specific scenarios they are made for. This creates room for error in a field where error is unacceptable. This report provides a recommended action for hoisting and rigging activities which require synthetic slings to contact a load, as well as recommended changes to industry standards which will benefit overall

  5. ZZ SNLRML, Dosimetry Cross-Section Recommendations

    International Nuclear Information System (INIS)

    1996-01-01

    Description of program or function: Format: SAND-II; Number of groups: 640 group SAND-II group structure. Nuclides: Cd, B, Au, S, Ni, Li, F, Na, Mg, Al, Si, P, Sc, Ti, Mn, Fe, Co, Cu, Zn, Zr, Nb, Mo, Rh, Ag, In, I, Th, U, Np, Pu, Am. Origin: ENDF/B-VI, ENDF/B-V, IRDF-90, JENDL-3, JEF 2.2 and GLUCS data with special modifications from private communications. Weighting spectrum: flat. SNLRML is a reactor dosimetry library that draws upon all available evaluated cross section libraries and selects the best evaluation for application to research reactor spectrum determinations. Many of the components of the SNLRML come from the ENDF/B-VI and IRDF-90 (DLC-0161) libraries. The library format was selected for easy interface with spectrum determination codes such as SAND-II (CCC-0112 and LSL-M2 (PSR-233) and the new PSR-0345/SNL/SAND-II has been enhanced to interface with SNLRML. The data is recommended for spectrum determination applications and for the prediction of neutron activation of typical radiation sensor materials. The library has been tested for consistency of the cross section in wide variety of neutron environments. The results and cautions from this testing have been documented. The data has been interfaced with radiation transport codes, such as TWODANT-SYS (CCC-0547) and MCNP (CCC-0200), in order to compare calculated and measured activities for benchmark reactor experiments

  6. May I Suggest? Comparing Three PLE Recommender Strategies

    OpenAIRE

    Mödritscher, Felix; Krumay, Barbara; El Helou, Sandy; Gillet, Denis; Nussbaumer, Alexander; Albert, Dietrich; Dahn, Ingo; Ullrich, Carsten

    2011-01-01

    Personal learning environment (PLE) solutions aim at empowering learners to design (ICT and web-based) environments for their learning activities, mashingup content and people and apps for different learning contexts. Widely used in other application areas, recommender systems can be very useful for supporting learners in their PLE-based activities, to help discover relevant content, peers sharing similar learning interests or experts on a specific topic. In this paper we examine the utilizat...

  7. A fuzzy recommendation system for daily water intake

    OpenAIRE

    Bin Dai; Rung-Ching Chen; Shun-Zhi Zhu; Chung-Yi Huang

    2016-01-01

    Water is one of the most important constituents of the human body. Daily consumption of water is thus necessary to protect human health. Daily water consumption is related to several factors such as age, ambient temperature, and degree of physical activity. These factors are generally difficult to express with exact numerical values. The main objective of this article is to build a daily water intake recommendation system using fuzzy methods. This system will use age, physical activity, and a...

  8. Recommender Systems for the Social Web

    CERN Document Server

    Pazos Arias, José J; Díaz Redondo, Rebeca P

    2012-01-01

    The recommendation of products, content and services cannot be considered newly born, although its widespread application is still in full swing. While its growing success in numerous sectors, the progress of the  Social Web has revolutionized the architecture of participation and relationship in the Web, making it necessary to restate recommendation and reconciling it with Collaborative Tagging, as the popularization of authoring in the Web, and  Social Networking, as the translation of personal relationships to the Web. Precisely, the convergence of recommendation with the above Social Web pillars is what motivates this book, which has collected contributions from well-known experts in the academy and the industry to provide a broader view of the problems that Social Recommenders might face with.  If recommender systems have proven their key role in facilitating the user access to resources on the Web, when sharing resources has become social, it is natural for recommendation strategies in the Social Web...

  9. RECOMMENDER SYSTEMS IN E-COMMERCE APPLICATIONS

    Directory of Open Access Journals (Sweden)

    Gyöngyvér KOVÁCS

    2016-12-01

    Full Text Available One of the major problem with online shopping is finingd the right product, because finding the right product presumes that we know its name, but in most cases it is not so. For this reason the users need help in the process of online searching/shopping. Recommender systems have became a popular technique and strategy for helping users to select desirable products or services. In the past few years the recommender systems have changed from novelties used by a few big e-commerce sites, to serious business tools that are re-shaping the world of e-commerce. In this paper, we provide a brief overview of the classification of recommendation systems based on technology used to create recommendations, and inputs they need from the customers. Furthermore we analyze a few algorithms used by recommender systems and we will also present some marketing recommender systems and their comparative analysis.

  10. Network-based recommendation algorithms: A review

    Science.gov (United States)

    Yu, Fei; Zeng, An; Gillard, Sébastien; Medo, Matúš

    2016-06-01

    Recommender systems are a vital tool that helps us to overcome the information overload problem. They are being used by most e-commerce web sites and attract the interest of a broad scientific community. A recommender system uses data on users' past preferences to choose new items that might be appreciated by a given individual user. While many approaches to recommendation exist, the approach based on a network representation of the input data has gained considerable attention in the past. We review here a broad range of network-based recommendation algorithms and for the first time compare their performance on three distinct real datasets. We present recommendation topics that go beyond the mere question of which algorithm to use-such as the possible influence of recommendation on the evolution of systems that use it-and finally discuss open research directions and challenges.

  11. Fusing Recommendations for Social Bookmarking Websites

    DEFF Research Database (Denmark)

    Bogers, Toine; van den Bosch, Antal

    2011-01-01

    Social bookmarking websites are rapidly growing in popularity. Recommender systems, a promising remedy to the information overload accompanying the explosive growth in content, are designed to identify which unseen content might be of interest to a particular user, based on his or her past...... that use tag overlap and metadata provide better results for social bookmarking data sets than the transaction patterns that are used traditionally in recommender systems research. In addition, we investigate how to fuse different recommendation approaches to further improve recommendation accuracy. We...... preferences. Most previous work in recommendation for social bookmarking suffers from a lack of comparisons between the different available approaches. In this article, we address this issue by comparing and evaluating eight recommendation approaches on four data sets from two domains. We find that approaches...

  12. ISFG: Recommendations on biostatistics in paternity testing

    DEFF Research Database (Denmark)

    Gjertson, David W; Brenner, Charles H; Baur, Max P

    2007-01-01

    The Paternity Testing Commission (PTC) of the International Society for Forensic Genetics has taken up the task of establishing the biostatistical recommendations in accordance with the ISO 17025 standards and a previous set of ISFG recommendations specific to the genetic investigations...... in paternity cases. In the initial set, the PTC recommended that biostatistical evaluations of paternity are based on a likelihood ratio principle - yielding the paternity index, PI. Here, we have made five supplementary biostatistical recommendations. The first recommendation clarifies and defines basic...... concepts of genetic hypotheses and calculation concerns needed to produce valid PIs. The second and third recommendations address issues associated with population genetics (allele probabilities, Y-chromosome markers, mtDNA, and population substructuring) and special circumstances (deficiency...

  13. Recommender system based on scarce information mining.

    Science.gov (United States)

    Lu, Wei; Chung, Fu-Lai; Lai, Kunfeng; Zhang, Liang

    2017-09-01

    Guessing what user may like is now a typical interface for video recommendation. Nowadays, the highly popular user generated content sites provide various sources of information such as tags for recommendation tasks. Motivated by a real world online video recommendation problem, this work targets at the long tail phenomena of user behavior and the sparsity of item features. A personalized compound recommendation framework for online video recommendation called Dirichlet mixture probit model for information scarcity (DPIS) is hence proposed. Assuming that each clicking sample is generated from a representation of user preferences, DPIS models the sample level topic proportions as a multinomial item vector, and utilizes topical clustering on the user part for recommendation through a probit classifier. As demonstrated by the real-world application, the proposed DPIS achieves better performance in accuracy, perplexity as well as diversity in coverage than traditional methods. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Breeders’ work after cultivar development - the stage of recommendation

    Directory of Open Access Journals (Sweden)

    Luiz Carlos Federizzi

    2012-12-01

    Full Text Available The development of new cultivars is the ultimate goal of breeding programs and is the result of many years of hard work and dedication of breeders and their teams. An important part of the process, often neglected by geneticists, is the stage from recommendation to the production of breeder seed (post-breeding. This paper discusses the role of the breeder in the recommendation, registration, protection and marketing of new cultivars. The breeder’s active participation in all phases of post-breeding is fundamental to ensure that the cultivar reaches farmers quickly and can provide the benefits expected by society

  15. Current Trends in Radiation Protection Recommendations

    International Nuclear Information System (INIS)

    Gomaa, M.A.

    2008-01-01

    The third generation of the ICRP recommendations was adopted in April 2007. The recommendations rely on situations (planned, emergency and existing), individual (occupational, public and patient) and radiation protection system (justification, optimization and dose limits). In the present work attention is paid to discuss the new recommendations and role of IAEA in updating its Basic Safety Standards for protection against ionizing radiation and safety of radiation sources and its impact for the national regulations

  16. Panorama of recommender systems to support learning

    OpenAIRE

    Drachsler, Hendrik; Verbert, Katrien; Santos, Olga; Manouselis, Nikos

    2015-01-01

    This chapter presents an analysis of recommender systems in Technology-Enhanced Learning along their 15 years existence (2000-2014). All recommender systems considered for the review aim to support educational stakeholders by personalising the learning process. In this meta-review 82 recommender systems from 35 different countries have been investigated and categorised according to a given classification framework. The reviewed systems have been classified into 7 clusters according to their c...

  17. Web Page Recommendation Using Web Mining

    OpenAIRE

    Modraj Bhavsar; Mrs. P. M. Chavan

    2014-01-01

    On World Wide Web various kind of content are generated in huge amount, so to give relevant result to user web recommendation become important part of web application. On web different kind of web recommendation are made available to user every day that includes Image, Video, Audio, query suggestion and web page. In this paper we are aiming at providing framework for web page recommendation. 1) First we describe the basics of web mining, types of web mining. 2) Details of each...

  18. Smart Mirror: Intelligent Makeup Recommendation and Synthesis

    OpenAIRE

    Nguyen, Tam V.; Liu, Luoqi

    2017-01-01

    The female facial image beautification usually requires professional editing softwares, which are relatively difficult for common users. In this demo, we introduce a practical system for automatic and personalized facial makeup recommendation and synthesis. First, a model describing the relations among facial features, facial attributes and makeup attributes is learned as the makeup recommendation model for suggesting the most suitable makeup attributes. Then the recommended makeup attributes...

  19. Rating Methods for Proactive Recommendation on Smartwatches

    OpenAIRE

    Janosch Maier, Wolfgang Wörndl

    2015-01-01

    This paper analyzes possible interaction methods for using a recommender system on a smartwatch. As prerequisite, we describe interaction patterns currently used by Android Wear applications. Based on a prototype implementation the interaction methods action buttons, two button card and swipes are compared against each other. In a user study, 31 participating students were asked to rate restaurant recommendations offered in the setting of a context-aware, proactive recommender system. For eac...

  20. Learning Points and Routes to Recommend Trajectories

    OpenAIRE

    Chen, Dawei; Ong, Cheng Soon; Xie, Lexing

    2016-01-01

    The problem of recommending tours to travellers is an important and broadly studied area. Suggested solutions include various approaches of points-of-interest (POI) recommendation and route planning. We consider the task of recommending a sequence of POIs, that simultaneously uses information about POIs and routes. Our approach unifies the treatment of various sources of information by representing them as features in machine learning algorithms, enabling us to learn from past behaviour. Info...