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.

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.

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 ...

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

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.

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.

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.

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

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....

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 ...

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.

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.

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.

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.

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.

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.

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...

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

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.

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.

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.

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.

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.

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.

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.
.

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.

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.

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 ...

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...

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.

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

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.

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).

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

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

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...

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...

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.
.

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.

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.

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....

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

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.

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.

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

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.
.

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.

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.

[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.

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.

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.

Comparative bioavailability of rifampicin, isoniazid and pyrazinamide from a four drug fixed dose combination with separate formulations at the same dose levels.

Science.gov (United States)

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

2004-05-19

Fixed dose combination (FDC) formulations became popular in the treatment of tuberculosis (TB) because of the better patient compliance, reduced risk of monotherapy and emergence of drug resistance in contrast to treatment with separate formulations of two to four first-line drugs. However, its successful implementation in national programs is limited by probable bioinequivalency of rifampicin if present in FDC form. In this regard, World Health Organization (WHO) and International Union Against Tuberculosis and Lung Disease (IUATLD) recommend FDCs only of proven bioavailability. Hence, bioequivalence study of four drug FDC tablet was conducted using 22 healthy male volunteers according to WHO recommended protocol to determine bioavailability of rifampicin, isoniazid and pyrazinamide compared to standard separate combination at the same dose level. The study was designed as two period, two treatment crossover experiment with a washout period of 1 week. Bioequivalence of rifampicin was estimated by plasma and urinary method for both rifampicin and its active metabolite, des-acetyl rifampicin whereas isoniazid and pyrazinamide were estimated from plasma. Mean concentration time profiles and all the pharmacokinetic parameters of rifampicin, isoniazid and pyrazinamide from FDC tablet were comparable to individual formulations and passed the bioequivalence test with power of the test above 95%. Further, bioequivalence of both rifampicin and isoniazid shows that in vitro interaction of rifampicin and isoniazid is clinically insignificant. Thus, it was concluded that FDC formulation is bioequivalent for rifampicin, isoniazid and pyrazinamide and ensures the successful treatment of TB without compromising therapeutic efficacy of any of these components of anti-TB therapy.

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

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

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....

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

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.

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

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...

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.

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.

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.

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

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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)

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.

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...

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

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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

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.

[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.

Biowaiver monograph for immediate-release solid oral dosage forms: acetylsalicylic acid.

Science.gov (United States)

Dressman, Jennifer B; Nair, Anita; Abrahamsson, Bertil; Barends, Dirk M; Groot, D W; Kopp, Sabine; Langguth, Peter; Polli, James E; Shah, Vinod P; Zimmer, Markus

2012-08-01

A biowaiver monograph for acetylsalicylic acid (ASA) is presented. Literature and experimental data indicate that ASA is a highly soluble and highly permeable drug, leading to assignment of this active pharmaceutical ingredient (API) to Class I of the Biopharmaceutics Classification System (BCS). Limited bioequivalence (BE) studies reported in the literature indicate that products that have been tested are bioequivalent. Most of the excipients used in products with a marketing authorization in Europe are not considered to have an impact on gastrointestinal motility or permeability. Furthermore, ASA has a wide therapeutic index. Thus, the risks to the patient that might occur if a nonbioequivalent product were to be incorrectly deemed bioequivalent according to the biowaiver procedure appear to be minimal. As a result, the BCS-based biowaiver procedure can be recommended for approval of new formulations of solid oral dosage forms containing ASA as the only API, including both multisource and reformulated products, under the following conditions: (1) excipients are chosen from those used in ASA products already registered in International Conference on Harmonization and associated countries and (2) the dissolution profiles of the test and the comparator products comply with the BE guidance. Copyright © 2012 Wiley Periodicals, Inc.

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

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.

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.

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.

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.

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

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.

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...

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.

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.

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.

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.

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.

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

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 ...

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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...

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

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.

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

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.

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.

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.

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.

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

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

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

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

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.

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.

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

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...

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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...

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.

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.

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

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.

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

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%.

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.

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.

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.)

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.

Pharmacology of biosimilar candidate drugs in rheumatology: a literature review.

Science.gov (United States)

Araújo, F; Cordeiro, I; Teixeira, F; Gonçalves, J; Fonseca, J E

2014-01-01

To review current evidence concerning pharmacology of biosimilar candidates to be used in rheumatology. A PubMed search up to August 2013 was performed using relevant search terms to include all studies assessing pharmacological properties of biosimilar candidates to be used in rheumatology. Data on study characteristics, type of intervention, pharmacokinetics (PK), pharmacodynamics (PD) and bioequivalence ratios was extracted. Of 280 articles screened, 5 fulfilled our inclusion criteria. Two trials, PLANETAS and PLANETRA, compared CT-P13 and infliximab in patients with active ankylosing spondylitis and rheumatoid arthritis, respectively. PK bioequivalence was demonstrated in the phase 1 PLANETAS trial by highly comparable area under the curve (AUC) and maximum drug concentrations (Cmax), whose geometric mean ratios fell between the accepted bioequivalence range of 80-125%. Equivalence in efficacy and safety was demonstrated in the phase 3 PLANETRA trial. Two phase 1 trials comparing etanercept biosimilar candidates TuNEX and HD203 in healthy volunteers showed a high degree of similarity in AUC and Cmax, with respective geometric mean ratios between PK bioequivalence range. The last included trial referred to GP2013, a rituximab biosimilar candidate, which demonstrated PK and PD bioequivalence to reference product in three different dosing regimens in cynomolgus monkeys. Infliximab, etanercept and rituximab biosimilar candidates have demonstrated PK bioequivalence in the trials included in this review. CT-P13 has recently been approved for use in the European market and the remaining biosimilar candidates are currently being tested in patients with rheumatoid arthritis.

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.

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)

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.

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.

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...

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...

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

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)

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.

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.

Safety and efficacy of generic drugs with respect to brand formulation

OpenAIRE

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

2013-01-01

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to gener...

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.

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

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.

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...

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.

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

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.

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.

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...

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.

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.

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.

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.

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....

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.

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)

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

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...

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.

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.

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.

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.

Biowaiver monograph for immediate-release solid oral dosage forms: bisoprolol fumarate.

Science.gov (United States)

Charoo, Naseem A; Shamsher, Areeg A A; Lian, Lai Y; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Groot, D W; Kopp, Sabine; Langguth, Peter; Polli, James; Shah, Vinod P; Dressman, Jennifer

2014-02-01

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing bisoprolol as the sole active pharmaceutical ingredient (API) are reviewed. Bisoprolol is classified as a Class I API according to the current Biopharmaceutics Classification System (BCS). In addition to the BCS class, its therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability problems are taken into consideration. Qualitative compositions of IR tablet dosage forms of bisoprolol with a marketing authorization (MA) in ICH (International Conference on Harmonisation) countries are tabulated. It was inferred that these tablets had been demonstrated to be bioequivalent to the innovator product. No reports of failure to meet BE standards have been made in the open literature. On the basis of all these pieces of evidence, a biowaiver can currently be recommended for bisoprolol fumarate IR dosage forms if (1) the test product contains only excipients that are well known, and used in normal amounts, for example, those tabulated for products with MA in ICH countries and (2) both the test and comparator dosage form are very rapidly dissolving, or, rapidly dissolving with similarity of the dissolution profiles demonstrated at pH 1.2, 4.5, and 6.8. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

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.

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.

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.

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.

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

IEA policies-G8 recommendations and an afterwards

International Nuclear Information System (INIS)

Onoda, Takao

2009-01-01

In response to threats posed to the future supply of energy and to the environment, the G8 leaders, in Gleneagles, UK in 2005, agreed to an initiative called the Gleneagles Plan of Action (GPOA) which addresses climate change, clean energy and sustainable development. In the GPOA, G8 leaders pledged to encourage the development of cleaner, more efficient and lower-emitting vehicles, and to promote their deployment by, among other means, asking the IEA to review existing standards and codes for vehicle efficiency and to identify best practices. In order to properly response to the above-mentioned requests from G8 leaders, the IEA has launched, among other activities, study on policies for 'transforming the way we use energy' focusing on end-use efficiency including the one in transport sector and made a comprehensive response to the GPOA at the 2008 G8 Summit Meeting in Japan with 25 recommendations on energy efficiency. Regarding these recommendations, the G8 leaders have proclaimed, in the G8 Hokkaido Toyako Summit Leaders Declaration, that they would maximize implementation of the IEA's 25 recommendations. This paper summarizes the IEA activities in transport sector regarding the GPOA and their findings and recommendations.

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

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...

Os estudos de bioequivalência: Relevância para a medicina veterinária

Directory of Open Access Journals (Sweden)

João Palermo-Neto

2008-12-01

Full Text Available Bioequivalence (BE studies are scientific methods that allow comparison of different medicinal products containing the same active substance, or different batches of the same medicinal products or, in a broad sense, different routes of administration of the same product.Actually, legislation on generic drugs and bioequivalence only exist in Brazil for drugs intended for human purposes. In the field of Veterinary Medicine, BE is being used in many countries as part of the necessary requirements for registration of animal health products, i.e., to provide efficacy and safety animal data and to allow consumers safety; indeed, they also assure the quality of the food derived from treated animals. The present manuscript was designed to review and discuss BE; for that, it was divided into three major parts: 1- understanding bioequivalence: importance of BE studies for animal and human health; 2- type of BE studies included; 3- general consideration on experimental design involved o BE studies

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.

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.

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.

A modified Delphi method toward multidisciplinary consensus on functional convalescence recommendations after abdominal surgery.

Science.gov (United States)

van Vliet, Daphne C R; van der Meij, Eva; Bouwsma, Esther V A; Vonk Noordegraaf, Antonie; van den Heuvel, Baukje; Meijerink, Wilhelmus J H J; van Baal, W Marchien; Huirne, Judith A F; Anema, Johannes R

2016-12-01

Evidence-based information on the resumption of daily activities following uncomplicated abdominal surgery is scarce and not yet standardized in medical guidelines. As a consequence, convalescence recommendations are generally not provided after surgery, leading to patients' insecurity, needlessly delayed recovery and prolonged sick leave. The aim of this study was to generate consensus-based multidisciplinary convalescence recommendations, including advice on return to work, applicable for both patients and physicians. Using a modified Delphi method among a multidisciplinary panel of 13 experts consisting of surgeons, occupational physicians and general practitioners, detailed recommendations were developed for graded resumption of 34 activities after uncomplicated laparoscopic cholecystectomy, laparoscopic and open appendectomy, laparoscopic and open colectomy and laparoscopic and open inguinal hernia repair. A sample of occupational physicians, general practitioners and surgeons assessed the recommendations on feasibility in daily practice. The response of this group of care providers was discussed with the experts in the final Delphi questionnaire round. Out of initially 56 activities, the expert panel selected 34 relevant activities for which convalescence recommendations were developed. After four Delphi rounds, consensus was reached for all of the 34 activities for all the surgical procedures. A sample of occupational physicians, general practitioners and surgeons regarded the recommendations as feasible in daily practice. Multidisciplinary convalescence recommendations regarding uncomplicated laparoscopic cholecystectomy, appendectomy (laparoscopic, open), colectomy (laparoscopic, open) and inguinal hernia repair (laparoscopic, open) were developed by a modified Delphi procedure. Further research is required to evaluate whether these recommendations are realistic and effective in daily practice.

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...

Personalized Approach to Nutrition of Children Athletes: Practical Recommendations

Directory of Open Access Journals (Sweden)

S. G. Makarova

2016-01-01

Full Text Available Adequate nutrition is the most important factor of children’s health, affecting not only his/her state of health, but also physical activity indicators. Children athletes, for compensating the energy cost, anabolic processes activation, and operability recovery, need an optimum diet with adequate protein, fats, carbohydrates, minerals and vitamins to cover the development and growth needs, as well as to recover from the physical and neuro-psychological stress. There are also certain requirements to food and drinking regime, especially during periods of intense training and competitions. Recommendations for the composition of diets for children athletes are developed and presented in a number of guidelines; however, studies show that the actual nutrition of almost half of the specialized children and youth Olympic reserve schools’ students does not meet the recommended standards. The article presents an overview of modern approaches to young athletes’ nutrition organization, and gives recommendations for personified diet correction and nutritive support depending on sports specialization, nature of physical activity, stage of training process, and individual features of a child.

Natalizumab treatment for multiple sclerosis: updated recommendations for patient selection and monitoring

DEFF Research Database (Denmark)

Kappos, Ludwig; Bates, David; Edan, Gilles

2011-01-01

Natalizumab, a highly specific α4-integrin antagonist, is approved for treatment of patients with active relapsing-remitting multiple sclerosis (RRMS). It is generally recommended for individuals who have not responded to a currently available first-line disease-modifying therapy or who have very......, based on additional long-term follow-up of clinical studies and post-marketing observations, including appropriate patient selection and management recommendations.......Natalizumab, a highly specific α4-integrin antagonist, is approved for treatment of patients with active relapsing-remitting multiple sclerosis (RRMS). It is generally recommended for individuals who have not responded to a currently available first-line disease-modifying therapy or who have very...... active disease. The expected benefits of natalizumab treatment have to be weighed against risks, especially the rare but serious adverse event of progressive multifocal leukoencephalopathy. In this Review, we revisit and update previous recommendations on natalizumab for treatment of patients with RRMS...

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.

Limited-sampling strategy models for estimating the pharmacokinetic parameters of 4-methylaminoantipyrine, an active metabolite of dipyrone

Directory of Open Access Journals (Sweden)

Suarez-Kurtz G.

2001-01-01

Full Text Available Bioanalytical data from a bioequivalence study were used to develop limited-sampling strategy (LSS models for estimating the area under the plasma concentration versus time curve (AUC and the peak plasma concentration (Cmax of 4-methylaminoantipyrine (MAA, an active metabolite of dipyrone. Twelve healthy adult male volunteers received single 600 mg oral doses of dipyrone in two formulations at a 7-day interval in a randomized, crossover protocol. Plasma concentrations of MAA (N = 336, measured by HPLC, were used to develop LSS models. Linear regression analysis and a "jack-knife" validation procedure revealed that the AUC0-¥ and the Cmax of MAA can be accurately predicted (R²>0.95, bias 0.85 of the AUC0-¥ or Cmax for the other formulation. LSS models based on three sampling points (1.5, 4 and 24 h, but using different coefficients for AUC0-¥ and Cmax, predicted the individual values of both parameters for the enrolled volunteers (R²>0.88, bias = -0.65 and -0.37%, precision = 4.3 and 7.4% as well as for plasma concentration data sets generated by simulation (R²>0.88, bias = -1.9 and 8.5%, precision = 5.2 and 8.7%. Bioequivalence assessment of the dipyrone formulations based on the 90% confidence interval of log-transformed AUC0-¥ and Cmax provided similar results when either the best-estimated or the LSS-derived metrics were used.

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...

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...

"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

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...

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...

Social and Behavioral Aspects of a Tag-Based Recommender System

DEFF Research Database (Denmark)

Durao, Frederico; Dolog, Peter

2009-01-01

Collaborative tagging has emerged as a useful means to organize and share resources on the Web. Recommender systems have been utilized tags for identifying similar resources and generate personalized recommendations. In this paper, we analyze social and behavioral aspects of a tag-based recommender...... system which suggests similar Web pages based on the similarity of their tags. Tagging behavior and language anomalies in tagging activities are some aspects examined from an experiment involving 38 people from 12 countries....

Implementation of the ICRP 2007 recommendations in Korea

International Nuclear Information System (INIS)

Cho, Kun-Woo

2008-01-01

Full text: International Commission on Radiological Protection (ICRP) is about to publish new recommendations on radiation protection. International Atomic Energy Agency (IAEA) is also under process in revising its International Basic Safety Standards (BSS) to take into account of the changes of the ICRP recommendations. As soon as the revision of the BSS is completed, Korean government is considering to implement those changes in the BSS and the ICRP recommendations into its national radiation protection laws and regulations. This paper introduces the current activities and future prospects in this matter. In the 2007 ICRP recommendations, there are some new concepts, principles and quantities such as the changes in the nominal risk coefficient for cancer and hereditary effects, new definitions on the tissue weighting factors and radiation weighting factors for neutron and proton, extended application of the dose constraints in all exposure situations in source-related radiation protection, and the introduction of new system of protection for non-human species. Based on the study carried out by KINS so far, the following points are identified as major areas that need for further in-depth review and consideration for the implementation of the ICRP 2007 recommendations into Korean radiation protection laws and regulations; changes in the radiation risk factors, radiation weighting factors and tissue weighting factors, maintenance of the ICRP 60 dose limits, practical application of the dose constraints and determination of the reference levels in many source to individual exposure relationships, change from process-based system to exposure situation-based system, strengthening of the principle of optimization in all exposure situations, system of radiation protection for the environment, practical application of the exclusion and exemption principles, active participation of the stake holders, changes in glossary etc. The study for the implementation of the ICRP

Coordinated bird monitoring: Technical recommendations for military lands

Science.gov (United States)

Bart, Jonathan; Manning, Ann; Fischer, Richard; Eberly, Chris

2012-01-01

following these procedures, DoD will minimize the possibility for a proposed action to unintentionally take migratory birds at a level that would violate any of the migratory bird treaties and potentially impact mission activities. In addition, implementing conservation and monitoring programs for migratory birds supports the ecosystem integrity necessary to sustain DoD's natural resources for the military mission.Non-compliance with the procedural requirements of the MBTA could result in a private party lawsuit under the Administrative Procedures Act (APA). A lawsuit filed under APA involving a Navy bombing range is the basis for a court ruling that unintentional take of migratory birds applies to federal actions. Ensuring the necessary data is available to adequately assess impacts of a proposed action will help avoid lawsuits or help ensure such lawsuits have no grounds. The data gathered in a bird monitoring program will provide the best scientific data available to assess the expected impacts of a proposed action on migratory bird species through the NEPA process. This report presents recommendations developed by the U.S. Geological Survey (USGS) for the Department of Defense (DoD) on establishing a "Coordinated Bird Monitoring (CBM) Plan." The CBM Plan is intended to ensure that DoD meets its conservation and regulatory responsibilities for monitoring birds (Chapter 1). The report relies heavily on recommendations in the report, "Opportunities for improving avian monitoring" (http://www.nabci-us.org/aboutnabci/monitoringreportfinal0307.pdf), by the U.S. North American Bird Conservation Initiative (U.S. NABCI Monitoring Subcommittee, 2007) and on a review of 358 current DoD bird monitoring programs carried out as part of this project (Chapter 2). This report contains 12 recommendations which, if followed, would result in a comprehensive, efficient, and useful approach to bird monitoring. The recommendations are based on the entire report but are presented together at

Implementation plan for the Defense Nuclear Facilities Safety Board Recommendation 90-7

International Nuclear Information System (INIS)

Borsheim, G.L.; Cash, R.J.; Dukelow, G.T.

1992-12-01

This document revises the original plan submitted in March 1991 for implementing the recommendations made by the Defense Nuclear Facilities Safety Board in their Recommendation 90-7 to the US Department of Energy. Recommendation 90-7 addresses safety issues of concern for 24 single-shell, high-level radioactive waste tanks containing ferrocyanide compounds at the Hanford Site. The waste in these tanks is a potential safety concern because, under certain conditions involving elevated temperatures and low concentrations of nonparticipating diluents, ferrocyanide compounds in the presence of oxidizing materials can undergo a runaway (propagating) chemical reaction. This document describes those activities underway by the Hanford Site contractor responsible for waste tank safety that address each of the six parts of Defense Nuclear Facilities Safety Board Recommendation 90-7. This document also identifies the progress made on these activities since the beginning of the ferrocyanide safety program in September 1990. Revised schedules for planned activities are also included

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)

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

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.

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...

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.

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.

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.

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.

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...

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

A Community-Driven Approach to Generate Urban Policy Recommendations for Obesity Prevention

Directory of Open Access Journals (Sweden)

Julia Díez

2018-03-01

Full Text Available There is an increasing research interest in targeting interventions at the neighborhood level to prevent obesity. Healthy urban environments require including residents’ perspectives to help understanding how urban environments relate to residents’ food choices and physical activity levels. We describe an innovative community-driven process aimed to develop environmental recommendations for obesity prevention. We conducted this study in a low-income area in Madrid (Spain, using a collaborative citizen science approach. First, 36 participants of two previous Photovoice projects translated their findings into policy recommendations, using an adapted logical framework approach. Second, the research team grouped these recommendations into strategies for obesity prevention, using the deductive analytical strategy of successive approximation. Third, through a nominal group session including participants, researchers, public health practitioners and local policy-makers, we discussed and prioritized the obesity prevention recommendations. Participants identified 12 policy recommendations related to their food choices and 18 related to their physical activity. The research team grouped these into 11 concrete recommendations for obesity prevention. The ‘top-three’ ranked recommendations were: (1 to adequate and increase the number of public open spaces; (2 to improve the access and cost of existing sports facilities and (3 to reduce the cost of gluten-free and diabetic products.

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. 

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.

A Mobile Ecotourism Recommendations System Using Cars-Context Aware Approaches

Directory of Open Access Journals (Sweden)

Yani Nurhadryani

2013-11-01

Full Text Available The requirements to fullfill mobility of ecotourism activities have been urgent to support each traveler with the mobile gadget application. The objective of this research is to develop an application of recommendation system based on online user personalization. This application provided features to recommendation of ecotourism based on profile user and current location, then supplied information about distance and facilities in each ecotourism place. The main of computation worked online which was based on approach called as CARS (Context Aware Recommender Systems algorithm. The result showed that the application framework succeeded to give appropriate recommendations and explaination on a mobile platform both in the form of profile based spatial data and user preferences.

Verification of dissolution test for doxycycline hyclate in capsules to implement into the pharmacopoeial monograph

OpenAIRE

Dobrova, Anna; Golovchenko, Olga; Georgiyants, Victoria

2018-01-01

The study of dissolution profiles is important as a cheap and easy supplement to bioequivalence research, and as a variation to such studies. This method is not outlined in the State Pharmacopoeia of Ukraine for the doxycycline capsules. Therefore, according to the current requirements, it was necessary to verify the procedure recommended by the US Pharmacopeia to confirm that this laboratory test will be reproduced correctly, and to use it in our further studies.The aim of our research was t...

Non-IID Recommender Systems: A Review and Framework of Recommendation Paradigm Shifting

Directory of Open Access Journals (Sweden)

Longbing Cao

2016-06-01

Full Text Available While recommendation plays an increasingly critical role in our living, study, work, and entertainment, the recommendations we receive are often for irrelevant, duplicate, or uninteresting products and services. A critical reason for such bad recommendations lies in the intrinsic assumption that recommended users and items are independent and identically distributed (IID in existing theories and systems. Another phenomenon is that, while tremendous efforts have been made to model specific aspects of users or items, the overall user and item characteristics and their non-IIDness have been overlooked. In this paper, the non-IID nature and characteristics of recommendation are discussed, followed by the non-IID theoretical framework in order to build a deep and comprehensive understanding of the intrinsic nature of recommendation problems, from the perspective of both couplings and heterogeneity. This non-IID recommendation research triggers the paradigm shift from IID to non-IID recommendation research and can hopefully deliver informed, relevant, personalized, and actionable recommendations. It creates exciting new directions and fundamental solutions to address various complexities including cold-start, sparse data-based, cross-domain, group-based, and shilling attack-related issues.

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...

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.

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.

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.

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.

LIFEREC: A Framework for Recommending Users from Past Life Experiences

Directory of Open Access Journals (Sweden)

MOHSIN ALI MEMON

2017-07-01

Full Text Available Life logging has been an eminent topic of concern in recent years with many researchers focusing on capturing daily life activities of human. With the proliferation of IoT (Internet of Things domain, the devices are now able to record human interaction for longer periods as well as transfer this data easily to other computing devices or cloud storage. This article proposes a novel framework named as LIFEREC which acquires information from IoT aware devices and sensors. It maintains activity profiles of various activities performed by the users in their daily lives. Furthermore, the framework provides recommendations when requested by an individual while taking into account the past life history and current context. Recent research on digitizing human life is quite efficient in amassing enormous data but futile in offering assistance for prospect decisions in life. The data gathered by the lifelog devices may be of a great help in taking decisions. The proposed system gives a new direction to existing mechanisms of providing recommendations by exploiting the current context and the past experiences of human life. The recommendations provided by our proposed system may be very helpful while performing those activities which have already been experienced in the past

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.

Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force

Science.gov (United States)

Smolen, Josef S; Breedveld, Ferdinand C; Burmester, Gerd R; Bykerk, Vivian; Dougados, Maxime; Emery, Paul; Kvien, Tore K; Navarro-Compán, M Victoria; Oliver, Susan; Schoels, Monika; Scholte-Voshaar, Marieke; Stamm, Tanja; Stoffer, Michaela; Takeuchi, Tsutomu; Aletaha, Daniel; Andreu, Jose Louis; Aringer, Martin; Bergman, Martin; Betteridge, Neil; Bijlsma, Hans; Burkhardt, Harald; Combe, Bernard; Durez, Patrick; Fonseca, Joao Eurico; Gibofsky, Alan; Gomez-Reino, Juan J; Graninger, Winfried; Hannonen, Pekka; Haraoui, Boulos; Kouloumas, Marios; Landewe, Robert; Martin-Mola, Emilio; Nash, Peter; Ostergaard, Mikkel; Östör, Andrew; Richards, Pam; Sokka-Isler, Tuulikki; Thorne, Carter; Tzioufas, Athanasios G; van Vollenhoven, Ronald; de Wit, Martinus

2016-01-01

Background Reaching the therapeutic target of remission or low-disease activity has improved outcomes in patients with rheumatoid arthritis (RA) significantly. The treat-to-target recommendations, formulated in 2010, have provided a basis for implementation of a strategic approach towards this therapeutic goal in routine clinical practice, but these recommendations need to be re-evaluated for appropriateness and practicability in the light of new insights. Objective To update the 2010 treat-to-target recommendations based on systematic literature reviews (SLR) and expert opinion. Methods A task force of rheumatologists, patients and a nurse specialist assessed the SLR results and evaluated the individual items of the 2010 recommendations accordingly, reformulating many of the items. These were subsequently discussed, amended and voted upon by >40 experts, including 5 patients, from various regions of the world. Levels of evidence, strengths of recommendations and levels of agreement were derived. Results The update resulted in 4 overarching principles and 10 recommendations. The previous recommendations were partly adapted and their order changed as deemed appropriate in terms of importance in the view of the experts. The SLR had now provided also data for the effectiveness of targeting low-disease activity or remission in established rather than only early disease. The role of comorbidities, including their potential to preclude treatment intensification, was highlighted more strongly than before. The treatment aim was again defined as remission with low-disease activity being an alternative goal especially in patients with long-standing disease. Regular follow-up (every 1–3 months during active disease) with according therapeutic adaptations to reach the desired state was recommended. Follow-up examinations ought to employ composite measures of disease activity that include joint counts. Additional items provide further details for particular aspects of the

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.

[Availability of generic drugs in the public sector and prices in the private sector in different regions of Brazil].

Science.gov (United States)

Miranda, Elaine Silva; Pinto, Cláudia Du Bocage Santos; dos Reis, André Luis de Almeida; Emmerick, Isabel Cristina Martins; Campos, Mônica Rodrigues; Luiza, Vera Lucia; Osorio-de-Castro, Claudia Garcia Serpa

2009-10-01

A study to identify availability and prices of medicines, according to type of provider, was conducted in the five regions of Brazil. A list of medicines to treat prevalent diseases was investigated, using the medicines price methodology developed by the World Health Organization and Health Action International, adapted for Brazil. In the public sector, bioequivalent (vis-à-vis reference brand) generics are less available than multisource products. For most medicines (71.4%), the availability of bioequivalent generics was less than 10%. In the private sector, the average number of different bioequivalent generic versions in the outlets was far smaller than the number of versions on the market. There was a positive correlation between the number of generics on the market, or those found at outlets, and the price variation in bioequivalent generic products, in relation to the maximum consumer price. It is estimated that price competition is occurring among bioequivalent generic drugs and between them and multisource products for the same substance, but not with reference brands.

Context-aware recommender system based on ontology for recommending tourist destinations at Bandung

Science.gov (United States)

Rizaldy Hafid Arigi, L.; Abdurahman Baizal, Z. K.; Herdiani, Anisa

2018-03-01

Recommender System is software that is able to provide personalized recommendation suits users’ needs. Recommender System has been widely implemented in various domains, including tourism. One approach that can be done for more personalized recommendations is the use of contextual information. This paper proposes a context aware recommender based ontology system in the tourism domain. The system is capable of recommending tourist destinations by using user preferences of the categories of tourism and contextual information such as user locations, weather around tourist destinations and close time of destination. Based on the evaluation, the system has accuracy of of 0.94 (item recommendation precision evaluated by expert) and 0.58 (implicitly from system-end user interaction). Based on the evaluation of user satisfaction, the system provides a satisfaction level of more than 0.7 (scale 0 to 1) for speed factors for providing liked recommendations (PE), informative description of recommendations (INF) and user trust (TR).

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.

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...

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

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.

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

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.

Motivate: towards context-aware recommendation mobile system for healthy living

NARCIS (Netherlands)

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

2011-01-01

This paper presents the practices of a research aiming at the design 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 on physical activities was developed. The goal of

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.

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.

Generic drugs: myths, facts, and limitations

Directory of Open Access Journals (Sweden)

Antonio Marzo

2012-10-01

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

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.

Development of a Recommender System based on Personal History

Science.gov (United States)

Tanaka, Katsuaki; Hori, Koichi; Yamamoto, Masato

The flood of information on the Internet makes a person who surf it without some strong intention strayed into it. One of the ways to control the balance between a person and the flood is a recommender system by computer, and many web sites use it. These systems work on a web site for the same kind of items. However the field of personal activity is not limited to handle the same kind of thing and a web site, but also offline area in the real world. To handle personal offline activities, LifeLog is proposed as method to record it, but the main purpose of LifeLog is recording a personal history. How to use a history has still been studied stage. The authors have developed a recommender system that captures personal context from history of personal online and offline activities, treats information on web sites as a large set of context, and finds out and extends overlap of them, then recommends information located there. The aim of the system is that a person can enjoy waves of information again. The system worked as a part of My-life Assist Service. It was a service for mobile phones provided by NTT DoCoMo, Inc. as a field experiment from Dec. 2007 to Feb. 2008.

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

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...

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

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.

A Sentiment-Enhanced Hybrid Recommender System for Movie Recommendation: A Big Data Analytics Framework

Directory of Open Access Journals (Sweden)

Yibo Wang

2018-01-01

Full Text Available Movie recommendation in mobile environment is critically important for mobile users. It carries out comprehensive aggregation of user’s preferences, reviews, and emotions to help them find suitable movies conveniently. However, it requires both accuracy and timeliness. In this paper, a movie recommendation framework based on a hybrid recommendation model and sentiment analysis on Spark platform is proposed to improve the accuracy and timeliness of mobile movie recommender system. In the proposed approach, we first use a hybrid recommendation method to generate a preliminary recommendation list. Then sentiment analysis is employed to optimize the list. Finally, the hybrid recommender system with sentiment analysis is implemented on Spark platform. The hybrid recommendation model with sentiment analysis outperforms the traditional models in terms of various evaluation criteria. Our proposed method makes it convenient and fast for users to obtain useful movie suggestions.

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.

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

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...

NCBO Ontology Recommender 2.0: an enhanced approach for biomedical ontology recommendation.

Science.gov (United States)

Martínez-Romero, Marcos; Jonquet, Clement; O'Connor, Martin J; Graybeal, John; Pazos, Alejandro; Musen, Mark A

2017-06-07

Ontologies and controlled terminologies have become increasingly important in biomedical research. Researchers use ontologies to annotate their data with ontology terms, enabling better data integration and interoperability across disparate datasets. However, the number, variety and complexity of current biomedical ontologies make it cumbersome for researchers to determine which ones to reuse for their specific needs. To overcome this problem, in 2010 the National Center for Biomedical Ontology (NCBO) released the Ontology Recommender, which is a service that receives a biomedical text corpus or a list of keywords and suggests ontologies appropriate for referencing the indicated terms. We developed a new version of the NCBO Ontology Recommender. Called Ontology Recommender 2.0, it uses a novel recommendation approach that evaluates the relevance of an ontology to biomedical text data according to four different criteria: (1) the extent to which the ontology covers the input data; (2) the acceptance of the ontology in the biomedical community; (3) the level of detail of the ontology classes that cover the input data; and (4) the specialization of the ontology to the domain of the input data. Our evaluation shows that the enhanced recommender provides higher quality suggestions than the original approach, providing better coverage of the input data, more detailed information about their concepts, increased specialization for the domain of the input data, and greater acceptance and use in the community. In addition, it provides users with more explanatory information, along with suggestions of not only individual ontologies but also groups of ontologies to use together. It also can be customized to fit the needs of different ontology recommendation scenarios. Ontology Recommender 2.0 suggests relevant ontologies for annotating biomedical text data. It combines the strengths of its predecessor with a range of adjustments and new features that improve its reliability

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)

Progress Implementing the IEA 25 Energy Efficiency Policy Recommendations

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-07-01

Significantly improving energy efficiency remains a priority for all countries. Meetings of G8 leaders and IEA ministers reaffirmed the critical role that improved energy efficiency can play in addressing energy security, environmental and economic challenges. Many IEA publications have also documented the essential role of energy efficiency. For example, the World Energy Outlook and the Energy Technology Perspectives reports identify energy efficiency as the most significant contributor to achieving energy security, economic and environmental goals. Energy efficiency is clearly the “first fuel” in the delivery of energy services in the coming low-carbon energy future. To support governments in their implementation of energy efficiency, the IEA recommended the adoption of specific energy efficiency policy measures to the G8 summits in 2006, 2007 and 2008. The consolidated set of recommendations to these summits is known as the ‘IEA 25 energy efficiency policy recommendations’ because it covers 25 fields of action across seven priority areas: cross-sectoral activity, buildings, appliances, lighting, transport, industry and energy utilities. The IEA estimates that if implemented globally without delay, the proposed actions could save as much as 7.6 giga tonnes (Gt) CO2/year by 2030 – almost 1.5 times the current annual carbon dioxide (CO2) emissions of the United States. The IEA 25 energy efficiency policy recommendations were developed to address policy gaps and priorities. This has two implications. First, the recommendations do not cover the full range of energy efficiency policy activity possible. Rather, they focus on priority energy efficiency policies identified by IEA analysis. Second, while IEA analysis, the energy efficiency professional literature and engagement with experts clearly demonstrate the broad benefits of these IEA priority measures, the recommendations are not weighted to reflect the different energy end-use make up of different

A Personalized Tag-Based Recommendation in Social Web Systems

DEFF Research Database (Denmark)

Durao, Frederico; Dolog, Peter

2009-01-01

-based recommender system which suggests similar Web pages based on the similarity of their tags from a Web 2.0 tagging application. The proposed approach extends the basic similarity calculus with external factors such as tag popularity, tag representativeness and the affinity between user and tag. In order...... to study and evaluate the recommender system, we have conducted an experiment involving 38 people from 12 countries using data from Del.icio.us , a social bookmarking web system on which users can share their personal bookmarks......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. In this paper, we present a tag...

Exercise for prevention of cardiovascular disease: Evidence-based recommendations

Directory of Open Access Journals (Sweden)

Geevar Zachariah

2017-01-01

Full Text Available Sedentary lifestyle is one of the major risk factors for cardiovascular disease (CVD. In India, a large percentage of the people are physically inactive with fewer than 10% engaging in recreational physical activity. Physical activity has many beneficial effects on the risk factors for CVD. Apart from improving fitness level, it decreases myocardial oxygen demand and improves myocardial perfusion. There is an inverse association between physical activity and all-cause mortality. In primary prevention, physical inactivity is associated with a two-fold increase in the risk for coronary events. In secondary prevention, data confirm the existence of an inverse dose–response relationship between cardiovascular fitness and the all-cause mortality in large populations of cardiovascular patients. Guidelines from the American authorities as well as the European Society of Cardiology provide specific recommendations for exercise depending on the clinical setting (primary or secondary prevention of CVD and the patient-specific factors (the patient's physical activity level and the perceived CVD risk. The present review summarizes the clinical evidence regarding the role of exercise in CVD prevention and the exercise recommendations from the leading Cardiac societies.

Recommender systems and the social web leveraging tagging data for recommender systems

CERN Document Server

Gedikli, Fatih

2013-01-01

There is an increasing demand for recommender systems due to the information overload users are facing on the Web. The goal of a recommender system is to provide personalized recommendations of products or services to users. With the advent of the Social Web, user-generated content has enriched the social dimension of the Web. As user-provided content data also tells us something about the user, one can learn the user's individual preferences from the Social Web. This opens up completely new opportunities and challenges for recommender systems research. Fatih Gedikli deals with the question of

Verbal and numerical consumer recommendations: switching between recommendation formats leads to preference inconsistencies.

Science.gov (United States)

Maciejovsky, Boris; Budescu, David V

2013-06-01

Many Web sites provide consumers with product recommendations, which are typically presented by a sequence of verbal reviews and numerical ratings. In three experiments, we demonstrate that when participants switch between formats (e.g., from verbal to numerical), they are more prone to preference inconsistencies than when they aggregate the recommendations within the same format (e.g., verbal). When evaluating recommendations, participants rely primarily on central-location measures (e.g., mean) and less on other distribution characteristics (e.g., variance). We explain our findings within the theoretical framework of stimulus-response compatibility and we make practical recommendations for the design of recommendation systems and Web portals.

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.

Recommendations for safer radiotherapy: what’s the message?

Energy Technology Data Exchange (ETDEWEB)

Dunscombe, Peter, E-mail: peter.dunscombe@albertahealthservices.ca [Department of Oncology, University of Calgary, Calgary, AB (Canada)

2012-09-28

Radiotherapy, with close to a million courses delivered per year in North America, is a very safe and effective intervention for a devastating disease. However, although rare, several deeply regrettable incidents have occurred in radiotherapy and have rightly been the subject of considerable public interest. Partly in response to reports of these incidents a variety of authoritative organizations across the globe has harnessed the expertise amongst their members in attempts to identify the measures that will make radiotherapy safer. While the intentions of all these organizations are clearly good it is challenging for the health care providers in the clinic to know where to start with so much advice coming from so many directions. Through a mapping exercise we have identified commonalities between recommendations made in seven authoritative documents and identified those issues most frequently cited. The documents reviewed contain a total of 117 recommendations. Using the 37 recommendations in “Towards Safer Radiotherapy” as the initial base layer, recommendations in the other documents were mapped, adding to the base layer to accommodate all the recommendations from the additional six documents as necessary. This mapping exercise resulted in the distillation of the original 117 recommendations down to 61 unique recommendations. Twelve topics were identified in three or more of the documents as being pertinent to the improvement of patient safety in radiotherapy. They are, in order of most to least cited: training, staffing, documentation, incident learning, communication, check lists, quality control and preventive maintenance, dosimetric audit, accreditation, minimizing interruptions, prospective risk assessment, and safety culture. This analysis provides guidance for the selection of those activities most likely to enhance safety and quality in radiotherapy based on the frequency of citation in selected recent authoritative literature.

Recommendations for safer radiotherapy: what’s the message?

International Nuclear Information System (INIS)

Dunscombe, Peter

2012-01-01

Radiotherapy, with close to a million courses delivered per year in North America, is a very safe and effective intervention for a devastating disease. However, although rare, several deeply regrettable incidents have occurred in radiotherapy and have rightly been the subject of considerable public interest. Partly in response to reports of these incidents a variety of authoritative organizations across the globe has harnessed the expertise amongst their members in attempts to identify the measures that will make radiotherapy safer. While the intentions of all these organizations are clearly good it is challenging for the health care providers in the clinic to know where to start with so much advice coming from so many directions. Through a mapping exercise we have identified commonalities between recommendations made in seven authoritative documents and identified those issues most frequently cited. The documents reviewed contain a total of 117 recommendations. Using the 37 recommendations in “Towards Safer Radiotherapy” as the initial base layer, recommendations in the other documents were mapped, adding to the base layer to accommodate all the recommendations from the additional six documents as necessary. This mapping exercise resulted in the distillation of the original 117 recommendations down to 61 unique recommendations. Twelve topics were identified in three or more of the documents as being pertinent to the improvement of patient safety in radiotherapy. They are, in order of most to least cited: training, staffing, documentation, incident learning, communication, check lists, quality control and preventive maintenance, dosimetric audit, accreditation, minimizing interruptions, prospective risk assessment, and safety culture. This analysis provides guidance for the selection of those activities most likely to enhance safety and quality in radiotherapy based on the frequency of citation in selected recent authoritative literature.

Recommendations for safer radiotherapy: what’s the message?

Directory of Open Access Journals (Sweden)

Peter eDunscombe

2012-09-01

Full Text Available Radiotherapy, with close to a million courses delivered per year in North America, is a very safe and effective intervention for a devastating disease. However, although rare, several deeply regrettable incidents have occurred in radiotherapy and have rightly been the subject of considerable public interest. Partly in response to reports of these incidents a variety of authoritative organizations across the globe has harnessed the expertise amongst their members in attempts to identify the measures that will make radiotherapy safer. While the intentions of all these organizations are clearly good it is challenging for the health care providers in the clinic to know where to start with so much advice coming from so many directions. Through a mapping exercise we have identified commonalities between recommendations made in seven authoritative documents and identified those issues most frequently cited. The documents reviewed contain a total of 117 recommendations. Using the 37 recommendations in Towards Safer Radiotherapy as the initial base layer, recommendations in the other documents were mapped, adding to the base layer to accommodate all the recommendations from the additional six documents as necessary. This mapping exercise resulted in the distillation of the original 117 recommendations down to 61 unique recommendations. Twelve topics were identified in three or more of the documents as being pertinent to the improvement of patient safety in radiotherapy. They are, in order of most to least cited: training, staffing, documentation, incident learning, communication, check lists, quality control and preventive maintenance, dosimetric audit, accreditation, minimizing interruptions, prospective risk assessment and safety culture. This analysis provides guidance for the selection of those activities most likely to enhance safety and quality in radiotherapy based on the frequency of citation in selected recent authoritative literature.

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.

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...

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.

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

Exercise recommendations for childhood cancer survivors exposed to cardiotoxic therapies: an institutional clinical practice initiative.

Science.gov (United States)

Okada, Maki; Meeske, Kathleen A; Menteer, Jondavid; Freyer, David R

2012-01-01

Childhood cancer survivors who have received treatment with anthracyclines are at risk for developing cardiomyopathy in dose-dependent fashion. Historically, restrictions on certain types of physical activity that were intended to preserve cardiac function have been recommended, based on a mixture of evidence-based and consensus-based recommendations. In the LIFE Cancer Survivorship & Transition Program at Children's Hospital Los Angeles, the authors reevaluated their recommendations for exercise in survivors who were exposed to anthracyclines, with or without irradiation in proximity to the myocardium. The primary goal was to develop consistent, specific, practical, safe, and (where possible) evidence-based recommendations for at-risk survivors in the program. To accomplish this, the authors referred to current exercise guidelines for childhood cancer survivors, consulted recent literature for relevant populations, and obtained input from the program's pediatric cardiology consultant. The resulting risk-based exercise recommendations are designed to complement current published guidelines, maximize safe exercise, and help childhood cancer survivors return to a normal life that emphasizes overall wellness and physical activity. This article describes a single institution's experience in modifying exercise recommendations for at-risk childhood survivors and includes the methods, findings, and current institutional practice recommendations along with sample education materials.

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...

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

Science.gov (United States)

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

2013-12-01

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

Recommendations for radioembolisation after liver surgery using yttrium-90 resin microspheres based on a survey of an international expert panel

International Nuclear Information System (INIS)

Samim, Morsal; Veenendaal, Linde M. van; Braat, Manon N.G.J.A.; Hoven, Andor F. van den; Bosch, Maurice A.A.J. van den; Lam, Marnix G.E.H.; Hillegersberg, Richard van; Sangro, Bruno; Kao, Yung Hsiang; Liu, Dave; Louie, John D.; Sze, Daniel Y.; Rose, Steven C.; Brown, Daniel B.; Ahmadzadehfar, Hojjat; Kim, Edward

2017-01-01

Guidelines on how to adjust activity in patients with a history of liver surgery who are undergoing yttrium-90 radioembolisation ( 90 Y-RE) are lacking. The aim was to study the variability in activity prescription in these patients, between centres with extensive experience using resin microspheres 90 Y-RE, and to draw recommendations on activity prescription based on an expert consensus. The variability in activity prescription between centres was investigated by a survey of international experts in the field of 90 Y-RE. Six representative post-surgical patients (i.e. comparable activity prescription, different outcome) were selected. Information on patients' disease characteristics and data needed for activity calculation was presented to the expert panel. Reported was the used method for activity prescription and whether, how and why activity reduction was found indicated. Ten experts took part in the survey. Recommendations on activity reduction were highly variable between the expert panel. The median intra-patient range was 44 Gy (range 18-55 Gy). Reductions in prescribed activity were recommended in 68% of the cases. In consensus, a maximum D Target of 50 Gy was recommended. With a current lack of guidelines, large variability in activity prescription in post-surgical patients undergoing 90 Y-RE exists. In consensus, D Target ≤50 Gy is recommended. (orig.)

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.

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.

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

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.

The Application of Standards and Recommendations to Clinical Ethics Consultation in Practice: An Evaluation at German Hospitals.

Science.gov (United States)

Schochow, Maximilian; Rubeis, Giovanni; Steger, Florian

2017-06-01

The executive board of the Academy for Ethics in Medicine (AEM) and two AEM working groups formulated standards and recommendations for clinical ethics consultation in 2010, 2011, and 2013. These guidelines comply with the international standards like those set by the American Society for Bioethics and Humanities. There is no empirical data available yet that could indicate whether these standards and recommendations have been implemented in German hospitals. This desideratum is addressed in the present study. We contacted 1.858 German hospitals between September 2013 and January 2014. A follow-up survey was conducted between October 2014 and January 2015. The data of the initial survey and the follow-up survey were merged and evaluated. The statements of the participants were compared with the standards and recommendations. The standards of the AEM concerning the tasks of clinical ethics consultation (including ethics consultation, ethics training and the establishment of policy guidelines) are employed by a majority of participants of the study. Almost all of these participants document their consultation activities by means of protocols or entries in the patient file. There are deviations from the recommendations of the AEM working groups regarding the drafting of statutes, activity reports, and financial support. The activities of clinical ethics consultation predominantly comply with the standards of the AEM and recommendations for the documentation. The recommendations for evaluation should be improved in practice. This applies particularly for activity reports in order to evaluate the activities. Internal evaluation could take place accordingly.

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…

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

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...

Social media mining and visualization for point-of-interest recommendation

Institute of Scientific and Technical Information of China (English)

Ren Xingyi; Song Meina; E Haihong; Song Junde

2017-01-01

With the rapid growth of location-based social networks (LBSNs),point-of-interest (POI) recommendation has become an important research problem.As one of the most representative social media platforms,Twitter provides various real-life information for POI recommendation in real time.Despite that POI recommendation has been actively studied,tweet images have not been well utilized for this research problem.State-of-the-art visual features like convolutional neural network (CNN) features have shown significant performance gains over the traditional bag-of-visual-words in unveiling the image's semantics.Unfortunately,they have not been employed for POI recommendation from social websites.Hence,how to make the most of tweet images to improve the performance of POI recommendation and visualization remains open.In this paper,we thoroughly study the impact of tweet images on POI recommendation for different POI categories using various visual features.A novel topic model called social media Twitter-latent Dirichlet allocation (SM-TwitterLDA) which jointly models five Twitter features,(i.e.,text,image,location,timestamp and hashtag) is designed to discover POIs from the sheer amount of tweets.Moreover,each POI is visualized by representative images selected on three predefined criteria.Extensive experiments have been conducted on a real-life tweet dataset to verify the effectiveness of our method.

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.

Quarterly report on Defense Nuclear Facilities Safety Board Recommendation 90-7 for the period ending December 31, 1992

International Nuclear Information System (INIS)

Cash, R.J.; Dukelow, G.T.; Forbes, C.J.

1993-03-01

This is the seventh quarterly report on the progress of activities addressing safety issues associated with Hanford Site high-level radioactive waste tanks that contain ferrocyanide compounds. In the presence of oxidizing materials, such as nitrates or nitrites, ferrocyanide can be made to explode in the laboratory by heating it to high temperatures [above 285 degrees C (545 degrees F)]. In the mid 1950s approximately 140 metric tons of ferrocyanide were added to 24 underground high-level radioactive waste tanks. An implementation plan (Cash 1991) responding to the Defense Nuclear Facilities Safety Board Recommendation 90-7 (FR 1990) was issued in March 1991 describing the activities that were planned and underway to address each of the six parts of Recommendation 90-7. A revision to the original plan was transmitted to US Department of Energy by Westinghouse Hanford Company in December 1992. Milestones completed this quarter are described in this report. Contents of this report include: Introduction; Defense Nuclear Facilities Safety Board Implementation Plan Task Activities (Defense Nuclear Facilities Safety Board Recommendation for enhanced temperature measurement, Recommendation for continuous temperature monitoring, Recommendation for cover gas monitoring, Recommendation for ferrocyanide waste characterization, Recommendation for chemical reaction studies, and Recommendation for emergency response planning); Schedules; and References. All actions recommended by the Defense Nuclear Facilities Safety Board for emergency planning by Hanford Site emergency preparedness organizations have been completed

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

Extracorporeal treatment for barbiturate poisoning: recommendations from the EXTRIP Workgroup.

Science.gov (United States)

Mactier, Robert; Laliberté, Martin; Mardini, Joelle; Ghannoum, Marc; Lavergne, Valery; Gosselin, Sophie; Hoffman, Robert S; Nolin, Thomas D

2014-09-01

The EXTRIP (Extracorporeal Treatments in Poisoning) Workgroup conducted a systematic review of barbiturate poisoning using a standardized evidence-based process to provide recommendations on the use of extracorporeal treatment (ECTR) in patients with barbiturate poisoning. The authors reviewed all articles, extracted data, summarized key findings, and proposed structured voting statements following a predetermined format. A 2-round modified Delphi method was used to reach a consensus on voting statements, and the RAND/UCLA Appropriateness Method was used to quantify disagreement. 617 articles met the search inclusion criteria. Data for 538 patients were abstracted and evaluated. Only case reports, case series, and nonrandomized observational studies were identified, yielding a low quality of evidence for all recommendations. Using established criteria, the workgroup deemed that long-acting barbiturates are dialyzable and short-acting barbiturates are moderately dialyzable. Four key recommendations were made. (1) The use of ECTR should be restricted to cases of severe long-acting barbiturate poisoning. (2) The indications for ECTR in this setting are the presence of prolonged coma, respiratory depression necessitating mechanical ventilation, shock, persistent toxicity, or increasing or persistently elevated serum barbiturate concentrations despite treatment with multiple-dose activated charcoal. (3) Intermittent hemodialysis is the preferred mode of ECTR, and multiple-dose activated charcoal treatment should be continued during ECTR. (4) Cessation of ECTR is indicated when clinical improvement is apparent. This report provides detailed descriptions of the rationale for all recommendations. In summary, patients with long-acting barbiturate poisoning should be treated with ECTR provided at least one of the specific criteria in the first recommendation is present. Copyright © 2014 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

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.

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

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 ).

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.

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 ...

Recommendations for radioembolisation after liver surgery using yttrium-90 resin microspheres based on a survey of an international expert panel

Energy Technology Data Exchange (ETDEWEB)

Samim, Morsal [University Medical Center Utrecht, Department of Surgery, Utrecht (Netherlands); University Medical Center Utrecht, Department of Radiology and Nuclear Medicine, Utrecht (Netherlands); Veenendaal, Linde M. van; Braat, Manon N.G.J.A.; Hoven, Andor F. van den; Bosch, Maurice A.A.J. van den; Lam, Marnix G.E.H. [University Medical Center Utrecht, Department of Radiology and Nuclear Medicine, Utrecht (Netherlands); Hillegersberg, Richard van [University Medical Center Utrecht, Department of Surgery, Utrecht (Netherlands); Sangro, Bruno [Clinica Universidad de Navarra-IDISNA and CIBEREHD, Liver Unit, Pamplona (Spain); Kao, Yung Hsiang [Cabrini Hospital, Department of Nuclear Medicine, Melbourne (Australia); Liu, Dave [Vancouver General Hospital, University of British Columbia, Department of Radiology, Vancouver, British Columbia (Canada); Louie, John D.; Sze, Daniel Y. [Stanford University Medical Center, Division of Interventional Radiology, Stanford (United States); Rose, Steven C. [University of California, Department of Radiology, San Diego (United States); Brown, Daniel B. [Vanderbilt University, Medical Center North, Department of Radiology, Nashville (United States); Ahmadzadehfar, Hojjat [University Hospital Bonn, Department of Nuclear Medicine, Bonn (Germany); Kim, Edward [Icahn School of Medicine at Mount Sinai, Division of Vascular and Interventional Radiology, New York (United States)

2017-12-15

Guidelines on how to adjust activity in patients with a history of liver surgery who are undergoing yttrium-90 radioembolisation ({sup 90}Y-RE) are lacking. The aim was to study the variability in activity prescription in these patients, between centres with extensive experience using resin microspheres {sup 90}Y-RE, and to draw recommendations on activity prescription based on an expert consensus. The variability in activity prescription between centres was investigated by a survey of international experts in the field of {sup 90}Y-RE. Six representative post-surgical patients (i.e. comparable activity prescription, different outcome) were selected. Information on patients' disease characteristics and data needed for activity calculation was presented to the expert panel. Reported was the used method for activity prescription and whether, how and why activity reduction was found indicated. Ten experts took part in the survey. Recommendations on activity reduction were highly variable between the expert panel. The median intra-patient range was 44 Gy (range 18-55 Gy). Reductions in prescribed activity were recommended in 68% of the cases. In consensus, a maximum D{sub Target} of 50 Gy was recommended. With a current lack of guidelines, large variability in activity prescription in post-surgical patients undergoing {sup 90}Y-RE exists. In consensus, D{sub Target} ≤50 Gy is recommended. (orig.)

Dietary recommendations: comparing dietary guidelines from Brazil and the United States.

Science.gov (United States)

Sichieri, Rosely; Chiuve, Stephanie E; Pereira, Rosângela Alves; Lopes, Aline Cristine Souza; Willett, Walter C

2010-11-01

The Brazilian dietary guidelines are based in part on mainstream United States' recommendations, in spite of the criticisms and shortcomings of the American guidelines. In this paper, Brazilian food guidelines are summarized and discussed in comparison with the USA recommendations. American and Brazilian dietary recommendations are quite similar in many aspects, particularly those related to variety in the diet, the importance of physical activity and weight management. Different to American guidelines, those from Brazil advise people to choose fresh foods, to prefer healthier types of fat, to limit trans fat intake and to eat good sources of protein, but does not recommend the consumption of whole grains. Besides the challenges related to their implementation, indicators for the evaluation of the effectiveness of these guidelines should be established from the beginning, particularly those related to changes in dietary habits and the prevalence of obesity.

A Sentiment-Enhanced Hybrid Recommender System for Movie Recommendation: A Big Data Analytics Framework

OpenAIRE

Wang, Yibo; Wang, Mingming; Xu, Wei

2018-01-01

Movie recommendation in mobile environment is critically important for mobile users. It carries out comprehensive aggregation of user’s preferences, reviews, and emotions to help them find suitable movies conveniently. However, it requires both accuracy and timeliness. In this paper, a movie recommendation framework based on a hybrid recommendation model and sentiment analysis on Spark platform is proposed to improve the accuracy and timeliness of mobile movie recommender system. In the propo...

Exercise redox biochemistry: Conceptual, methodological and technical recommendations

Directory of Open Access Journals (Sweden)

James N. Cobley

2017-08-01

Full Text Available Exercise redox biochemistry is of considerable interest owing to its translational value in health and disease. However, unaddressed conceptual, methodological and technical issues complicate attempts to unravel how exercise alters redox homeostasis in health and disease. Conceptual issues relate to misunderstandings that arise when the chemical heterogeneity of redox biology is disregarded: which often complicates attempts to use redox-active compounds and assess redox signalling. Further, that oxidised macromolecule adduct levels reflect formation and repair is seldom considered. Methodological and technical issues relate to the use of out-dated assays and/or inappropriate sample preparation techniques that confound biochemical redox analysis. After considering each of the aforementioned issues, we outline how each issue can be resolved and provide a unifying set of recommendations. We specifically recommend that investigators: consider chemical heterogeneity, use redox-active compounds judiciously, abandon flawed assays, carefully prepare samples and assay buffers, consider repair/metabolism, use multiple biomarkers to assess oxidative damage and redox signalling. Keywords: Exercise, Oxidative stress, Free radical, Antioxidants, Redox signalling

Exercise redox biochemistry: Conceptual, methodological and technical recommendations.

Science.gov (United States)

Cobley, James N; Close, Graeme L; Bailey, Damian M; Davison, Gareth W

2017-08-01

Exercise redox biochemistry is of considerable interest owing to its translational value in health and disease. However, unaddressed conceptual, methodological and technical issues complicate attempts to unravel how exercise alters redox homeostasis in health and disease. Conceptual issues relate to misunderstandings that arise when the chemical heterogeneity of redox biology is disregarded: which often complicates attempts to use redox-active compounds and assess redox signalling. Further, that oxidised macromolecule adduct levels reflect formation and repair is seldom considered. Methodological and technical issues relate to the use of out-dated assays and/or inappropriate sample preparation techniques that confound biochemical redox analysis. After considering each of the aforementioned issues, we outline how each issue can be resolved and provide a unifying set of recommendations. We specifically recommend that investigators: consider chemical heterogeneity, use redox-active compounds judiciously, abandon flawed assays, carefully prepare samples and assay buffers, consider repair/metabolism, use multiple biomarkers to assess oxidative damage and redox signalling. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Vulnerability and adaptation to climate change in the arctic (VACCA): Implementing recommendations

Energy Technology Data Exchange (ETDEWEB)

NONE

2011-07-01

This report provides recommendations for how Norway's government could move forward with the results from the Arctic Council supported VACCA project, suggesting how concrete activities may be implemented and applied to policy and practice. Based on the results of interviews with Arctic peoples and people involved in Arctic work, combined with desk studies of relevant literature, four Arctic contexts are defined within the dividing lines coastal/non-coastal and urban/non-urban. This report provides up to five concrete recommendations within each context, recommendations for cross-contextual action, and specific projects for further research and action.(auth)

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.

Portuguese recommendations for the use of biological therapies in patients with axial spondyloarthritis – 2016 update

Directory of Open Access Journals (Sweden)

Pedro Machado

2017-07-01

Full Text Available Objective: To update the recommendations for the treatment of axial spondyloarthritis (axSpA with biological therapies, endorsed by the Portuguese Society of Rheumatology. Methods: These treatment recommendations were formulated by Portuguese rheumatologists based on literature evidence and consensus opinion. At a national meeting, the 7 recommendations included in this document were discussed and updated. A draft of the full text of the recommendations was then circulated and suggestions were incorporated. A final version was again circulated before publication and the level of agreement among Portuguese Rheumatologists was anonymously assessed using an online survey. Results: A consensus was achieved regarding the initiation, assessment of response and switching of biological therapies in patients with axSpA. In total, seven recommendations were produced. The first recommendation is a general statement indicating that biological therapy is not a first-line drug treatment option and should only be used after conventional treatment has failed. The second recommendation is also a general statement about the broad concept of axSpA adopted by these recommendations that includes both non-radiographic and radiographic axSpA. Recommendations 3 to 7 deal with the definition of active disease (including the recommended threshold of 2.1 for the Ankylosing Spondylitis Disease Activity Score [ASDAS] or the threshold of 4 [0-10 scale] for the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], conventional treatment failure (nonsteroidal anti-inflammatory drugs being the first-line drug treatment, assessment of response to treatment (based on an ASDAS improvement  of at least 1.1 units or a BASDAI improvement of at least 2 units [0-10 scale] or at least 50%, and strategy in the presence of an inadequate response (where switching is recommended or in the presence of long-term remission (where a process of biological therapy optimization can be

Recommendations of the Brazilian Society of Rheumatology for the induction therapy of ANCA-associated vasculitis

Directory of Open Access Journals (Sweden)

Alexandre Wagner Silva de Souza

Full Text Available Abstract The purpose of these recommendations is to guide the appropriate induction treatment of antineutrophil cytoplasmic antibody-associated vasculitis (AAV patients with active disease. The recommendations proposed by the Vasculopathies Committee of the Brazilian Society Rheumatology for induction therapy of AAV, including granulomatosis with polyangiitis, microscopic polyangiitis and renal-limited vasculitis, were based on systematic literature review and expert opinion. Literature review was performed using Medline (PubMed, EMBASE and Cochrane database to retrieve articles until October 2016. PRISMA guidelines were used for the systematic review and articles were assessed according to the Oxford levels of evidence. Sixteen recommendations were made regarding different aspects of induction therapy for AAV. The purpose of these recommendations is to serve as a guide for therapeutic decisions by health care professionals in the management of AAV patients presenting active disease.

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

Science.gov (United States)

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

2015-01-01

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

Treating juvenile idiopathic arthritis to target: recommendations of an international task force.

Science.gov (United States)

Ravelli, Angelo; Consolaro, Alessandro; Horneff, Gerd; Laxer, Ronald M; Lovell, Daniel J; Wulffraat, Nico M; Akikusa, Jonathan D; Al-Mayouf, Sulaiman M; Antón, Jordi; Avcin, Tadej; Berard, Roberta A; Beresford, Michael W; Burgos-Vargas, Ruben; Cimaz, Rolando; De Benedetti, Fabrizio; Demirkaya, Erkan; Foell, Dirk; Itoh, Yasuhiko; Lahdenne, Pekka; Morgan, Esi M; Quartier, Pierre; Ruperto, Nicolino; Russo, Ricardo; Saad-Magalhães, Claudia; Sawhney, Sujata; Scott, Christiaan; Shenoi, Susan; Swart, Joost F; Uziel, Yosef; Vastert, Sebastiaan J; Smolen, Josef S

2018-06-01

Recent therapeutic advances in juvenile idiopathic arthritis (JIA) have made remission an achievable goal for most patients. Reaching this target leads to improved outcomes. The objective was to develop recommendations for treating JIA to target. A Steering Committee formulated a set of recommendations based on evidence derived from a systematic literature review. These were subsequently discussed, amended and voted on by an international Task Force of 30 paediatric rheumatologists in a consensus-based, Delphi-like procedure. Although the literature review did not reveal trials that compared a treat-to-target approach with another or no strategy, it provided indirect evidence regarding an optimised approach to therapy that facilitated development of recommendations. The group agreed on six overarching principles and eight recommendations. The main treatment target, which should be based on a shared decision with parents/patients, was defined as remission, with the alternative target of low disease activity. The frequency and timeline of follow-up evaluations to ensure achievement and maintenance of the target depend on JIA category and level of disease activity. Additional recommendations emphasise the importance of ensuring adequate growth and development and avoiding long-term systemic glucocorticoid administration to maintain the target. All items were agreed on by more than 80% of the members of the Task Force. A research agenda was formulated. The Task Force developed recommendations for treating JIA to target, being aware that the evidence is not strong and needs to be expanded by future research. These recommendations can inform various stakeholders about strategies to reach optimal outcomes for JIA. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Generating Private Recommendations Efficiently Using Homomorphic Encryption and Data Packing

DEFF Research Database (Denmark)

Erkin, Zekeriya; Veugen, Thijs; Toft, Tomas

2012-01-01

Recommender systems have become an important tool for personalization of online services. Generating recommendations in online services depends on privacy-sensitive data collected from the users. Traditional data protection mechanisms focus on access control and secure transmission, which provide...... them under encryption to generate recommendations. By introducing a semitrusted third party and using data packing, we construct a highly efficient system that does not require the active participation of the user. We also present a comparison protocol, which is the first one to the best of our...... security only against malicious third parties, but not the service provider. This creates a serious privacy risk for the users. In this paper, we aim to protect the private data against the service provider while preserving the functionality of the system. We propose encrypting private data and processing...

Recommendations for prevention of radiation accident in industrial gammagraphy

International Nuclear Information System (INIS)

Souza, L.S.; Silva, F.C.A. da

2017-01-01

Industrial Gammagraphy plays an important role in the quality control of various materials and components. It is classified by the International Atomic Energy Agency - IAEA as Category 2, due to its radiation risk caused by the use of high activity radioactive sources. This risk is based on the harmful consequences of human health, described in some accidents in the world, due to failures. In 2012, the 'Brazilian National Workshop on Accident Prevention in Industrial Gammagraphy' was carried out by DIAPI/CNEN, with the objective of disseminating knowledge about radiation accidents. At the time, the IRD/CNEN-RJ carried out a survey with the 75 participants using a form with 22 recommendations to prevent radiological accidents, in order to select the 10 most voted. A statistical study, using the 'Frequency Distribution' method, was performed to define 10 recommendations. The percentage and vote results were obtained by category of the participants and the 10 most important recommendations were defined to prevent radiation accidents. The recommendation that came in first place was 'Always use an individual monitor with alarm during all work'

Lifestyle change recommendations in major depression: Do they work?

Science.gov (United States)

Serrano Ripoll, M J; Oliván-Blázquez, B; Vicens-Pons, E; Roca, M; Gili, M; Leiva, A; García-Campayo, J; Demarzo, M P; García-Toro, M

2015-09-01

Modifying some lifestyle factors can be useful in depression, at least as an adjuvant treatment. Combining different lifestyle interventions seems to be an adequate strategy to increase their antidepressant efficacy according with preliminary studies, but this issue has not been enough investigated. The present study is a randomized, double-blinded, multicentre, two arm-parallel clinical trials, with a 12 month follow-up. The sample consisted of 273 Primary Care patients. Four combined hygienic-dietary written recommendations were given to the patients about diet, exercise, light exposure and sleep hygiene. Both active and control interventions were associated with improvement on BDI (Beck Depression Inventory) scores. However, there were not statistically significant differences (7.0 vs. 7.6; p=0.594). We were unable to monitor whether patients carry out recommendations. Intervention could be too difficult to accomplish for depressed patients without enough support and supervision. Just giving written lifestyle recommendations are not enough for depressive patients to benefit from them, so perhaps lifestyle change recommendations work or do not work on Depression depending on how they are presented to patients and on monitoring systems of their implementation. Copyright © 2015 Elsevier B.V. All rights reserved.

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

21 CFR 320.27 - Guidelines on the design of a multiple-dose in vivo bioavailability study.

Science.gov (United States)

2010-04-01

... vivo bioavailability study. 320.27 Section 320.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.27...

Characteristics of attitude and recommendation of oncologists toward exercise in South Korea: a cross sectional survey study.

Science.gov (United States)

Park, Ji-Hye; Oh, Minsuk; Yoon, Yong Jin; Lee, Chul Won; Jones, Lee W; Kim, Seung Il; Kim, Nam Kyu; Jeon, Justin Y

2015-04-10

The purpose of the present study was to examine 1) characteristics and attitudes of oncologists toward exercise and toward recommending exercise to their patients, 2) association among oncologists' own physical activity levels, exercise recommendations, and their attitudes toward recommending exercise. A total of 167 oncologists participated in this survey study (41 surgeons, 78 medical oncologists, 25 radiation oncologists, and 21 others). Most oncologists included in the study treat more than one type of cancer, including colorectal, gastric, breast, lung, and liver cancer. To analyze the data, the one-way ANOVA, and t-test were used. All data were indicated for mean, SD, and proportions. Most oncologists agreed that exercise is beneficial (72.8%) and important (69.6%), but only 39.2% of them agreed that exercise is safe, and only 7.2% believed that cancer patients manage to exercise during cancer treatment. Forty-six percentage of the surveyed oncologists recommended exercise to their patients during the past month. The average amount of participation in physical activity by oncologists who participated in the study was 139.5 ± 120.3 min per week, and 11.4% of the study participants met the American College of Sports Medicine (ACSM) guidelines. Oncologists' own physical activity levels were associated with their attitudes toward recommending exercise. Belief in the benefits of exercise in the performance of daily tasks, improvement of mental health, and the attenuation of physical decline from treatment were the three most prevalent reasons why oncologists recommend exercise to their patients. Barriers to recommending exercise to patients included lack of time, unclear exercise recommendations, and the safety of patients. Oncologists have favorable attitudes toward exercise and toward recommending exercise to their patients during treatment. However, they also experience barriers to recommending exercise, including lack of time, unclear exercise guidelines

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 ...

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.

The omni-relevance of surgery: how medical specialization shapes orthopedic surgeons' treatment recommendations.

Science.gov (United States)

Hudak, Pamela L; Clark, Shannon J; Raymond, Geoffrey

2013-01-01

This article examines treatment recommendations in orthopedic surgery consultations and shows how surgery is treated as "omni-relevant" within this activity, providing a context within which the broad range of treatment recommendations proposed by surgeons is offered. Using conversation analysis to analyse audiotaped encounters between orthopedic surgeons and patients, we highlight how surgeons treat surgery as having a special, privileged status relative to other treatment options by (1) invoking surgery (whether or not it is actually being recommended) and (2) presenting surgery as the "last best resort" (in relation to which other treatment options are calibrated, described and considered). This privileged status surfaces in the design and delivery of recommendations as a clear asymmetry: Recommendations for surgery are proposed early, in relatively simple and unmitigated form. In contrast, recommendations not for surgery tend to be delayed and involve significantly more interactional work in their delivery. Possible implications of these findings, including how surgeons' structuring of recommendations may shape patient expectations (whether for surgery or some alternative), and potentially influence the distribution of orthopedic surgery procedures arising from these consultations, are considered.

Receiving recommendations and providing feedback : the user-experience of a recommender system

NARCIS (Netherlands)

Knijnenburg, B.P.; Willemsen, M.C.; Hirtbach, S.; Buccafurri, F.; Semeraro, G.

2010-01-01

This paper systematically evaluates the user experience of a recommender system. Using both behavioral data and subjective measures of user experience, we demonstrate that choice satisfaction and system effectiveness increase when a system provides personalized recommendations (compared to the same

Multimedia services in intelligent environments advances in recommender systems

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 Advances in Recommender Systems. Recommender systems are crucial in multimedia services, as they aim at protecting the service users from information overload. The book includes nine chapters, which present various recent research results in recommender systems. This resear...

Location-aware News Recommendation System with Using Fuzzy Logic

Directory of Open Access Journals (Sweden)

Mehdi Nejati

2016-10-01

Full Text Available with release of a huge amount of news on the Internet and the trend of users to Web-based news services.it is necessary to have a recommendation system. To grab attentions to news, news services use a number of criteria that called news values and user location is an important factor for it. In this paper, LONEF is proposed as a tow stage recommendation system. In first stage news are ranked by user’s locations and in second stage news are recommended by location Preferences, recency, Trustworthiness, groups priorities and popularity. To reduce ambiguity these properties is used tow Mamdani fuzzy interference and case-based decision systems. In Mamdani fuzzy interference system, it is tried to increase the system speed by optimizing selection of rules and membership functions and because of ambiguous feedback implementation, a decision making system is used to enable better simulation of user’s activities. Performance of our proposed approach is demonstrated in the experiments on different news groups.

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...

Short convalescence after inguinal herniorrhaphy with standardised recommendations: duration and reasons for delayed return to work

DEFF Research Database (Denmark)

Callesen, T; Klarskov, B; Bech, K

1999-01-01

inguinal herniorrhaphy under local anaesthesia. One day convalescence for light/moderate and three weeks for strenuous physical activity was recommended. MAIN OUTCOME MEASURE: Duration of absence from work or main recreational activity. RESULTS: Overall median absence (including the day of operation) was 6...... the general practitioner in 12. Pain was the main cause of impairment of activities of daily living. CONCLUSION: Well-defined recommendations for convalescence may, together with improved management of postoperative pain, shorten convalescence; they are essential in the evaluation of effects of different...

21 CFR 320.38 - Retention of bioavailability samples.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Retention of bioavailability samples. 320.38... (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.38 Retention of bioavailability samples...

[Nutrition in pregnancy - Practice recommendations of the Network "Healthy Start - Young Family Network"].

Science.gov (United States)

Koletzko, B; Bauer, C-P; Bung, P; Cremer, M; Flothkötter, M; Hellmers, C; Kersting, M; Krawinkel, M; Przyrembel, H; Rasenack, R; Schäfer, T; Vetter, K; Wahn, U; Weißenborn, A; Wöckel, A

2012-06-01

Nutrition, physical activity and lifestyle in pregnancy influence maternal and child health. The "Healthy start - Young Family Network" supported by the German Government with the national action plan IN FORM developed recommendations on nutrition in pregnancy. Folic acid supplements (400 µg/day) should be started before pregnancy and continue for at least the first trimester. Iodine rich foods and salt and an iodine supplement (100-150 µg/day) are recommended. Long-chain omega-3 fatty acids should be provided with ≥ 1 weekly portion of oily sea fish, or a DHA-supplement if regular fish consumption is avoided. Vitamin D supplementation is advisable unless there is regular exposure to sunlight. Iron supplements should be used based on medical history and blood testing. Vegetarian diets with nutritional supplements can provide adequate nutrition, but counselling is recommended. In contrast, a vegan diet is inadequate and requires additional micronutrient supplementation. For risk reduction of listeriosis and toxoplasmosis, raw animal foods, soft cheeses and packed fresh salads should be avoided; fresh fruit, vegetables and salad should be washed well and consumed promptly. Pregnant women should remain physically active and perform sports with moderate intensity. They should avoid alcohol, active and passive smoking. Up to 3 daily cups of coffee are considered harmless, but energy drinks should be avoided. Childhood allergy is not reduced by avoiding certain foods in pregnancy whereas oily sea fish is recommended. Health care professions should lead parents to health-promoting lifestyles. Subjects of part 1 of the article are practice recommendations on nutrition, on energy needs, micronutrient needs and body weight/weight gain in pregnancy. © Georg Thieme Verlag KG Stuttgart · New York.

Physical Activity

DEFF Research Database (Denmark)

Andersen, Lars Bo; Anderssen, Sigmund Alfred; Wisløff, Ulrik

2014-01-01

Andersen LB, Anderssen SA, Wisløff U, Hellénius M-L, Fogelholm M, Ekelund U. (Expert Group) Nordic Nutrition Recommendations 2012. Integrating nutrition and physical activity. Chapter: Physical Activity p. 195-217.Nordic Counsil of Ministers.......Andersen LB, Anderssen SA, Wisløff U, Hellénius M-L, Fogelholm M, Ekelund U. (Expert Group) Nordic Nutrition Recommendations 2012. Integrating nutrition and physical activity. Chapter: Physical Activity p. 195-217.Nordic Counsil of Ministers....

Establishment of in vitro-in vivo equivalence of highly variable drugs - a generic product development perspective.

Science.gov (United States)

Pathak, Shriram M; Aggarwal, Deepika; Venkateswarlu, V

2014-06-01

In vivo equivalence of highly variable drugs (HVD) has always been a subject of great concern, in terms of both safety and efficacy, for regulatory agencies. Successful demonstration of their bioequivalence thus presents the most crucial component of a generic application, significantly contributing toward the cost and time of development. For poorly soluble drugs, such as telmisartan, dissolution represents the rate-limiting step in the gastric region and in many cases may not be complete, thereby contributing to low and highly variable bioavailability. Consequently, simulation of gastrointestinal conditions is essential to adequately predict the in vivo behavior of drug formulations. In this study, we evaluated usefulness of physiologically relevant dissolution method over commonly used acidic media to forecast comparable in vivo performance of telmisartan formulation to that of reference samples. In the present study, telmisartan was classified as a HVD and a partial replicate design with repeating the reference product and scaling the bioequivalence for the reference variability has been presented. The design has effectively decreased sample size, without increasing patient risk. Results from this project suggest that scaled average bioequivalence (SABE) provides a good approach for evaluating the bioequivalence of HVD, meeting the need for international guidelines for bioequivalence.

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

2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis.

Science.gov (United States)

van der Heijde, Désirée; Ramiro, Sofia; Landewé, Robert; Baraliakos, Xenofon; Van den Bosch, Filip; Sepriano, Alexandre; Regel, Andrea; Ciurea, Adrian; Dagfinrud, Hanne; Dougados, Maxime; van Gaalen, Floris; Géher, Pál; van der Horst-Bruinsma, Irene; Inman, Robert D; Jongkees, Merryn; Kiltz, Uta; Kvien, Tore K; Machado, Pedro M; Marzo-Ortega, Helena; Molto, Anna; Navarro-Compàn, Victoria; Ozgocmen, Salih; Pimentel-Santos, Fernando M; Reveille, John; Rudwaleit, Martin; Sieper, Jochen; Sampaio-Barros, Percival; Wiek, Dieter; Braun, Jürgen

2017-06-01

To update and integrate the recommendations for ankylosing spondylitis and the recommendations for the use of tumour necrosis factor inhibitors (TNFi) in axial spondyloarthritis (axSpA) into one set applicable to the full spectrum of patients with axSpA. Following the latest version of the European League Against Rheumatism (EULAR) Standardised Operating Procedures, two systematic literature reviews first collected the evidence regarding all treatment options (pharmacological and non-pharmacological) that were published since 2009. After a discussion of the results in the steering group and presentation to the task force, overarching principles and recommendations were formulated, and consensus was obtained by informal voting. A total of 5 overarching principles and 13 recommendations were agreed on. The first three recommendations deal with personalised medicine including treatment target and monitoring. Recommendation 4 covers non-pharmacological management. Recommendation 5 describes the central role of non-steroidal anti-inflammatory drugs (NSAIDs) as first-choice drug treatment. Recommendations 6-8 define the rather modest role of analgesics, and disprove glucocorticoids and conventional synthetic disease-modifying antirheumatic drugs (DMARDs) for axSpA patents with predominant axial involvement. Recommendation 9 refers to biological DMARDs (bDMARDs) including TNFi and IL-17 inhibitors (IL-17i) for patients with high disease activity despite the use (or intolerance/contraindication) of at least two NSAIDs. In addition, they should either have an elevated C reactive protein and/or definite inflammation on MRI and/or radiographic evidence of sacroiliitis. Current practice is to start with a TNFi. Switching to another TNFi or an IL-17i is recommended in case TNFi fails (recommendation 10). Tapering, but not stopping a bDMARD, can be considered in patients in sustained remission (recommendation 11). The final two recommendations (12, 13) deal with surgery and

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

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)

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.

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....

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.

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.

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)

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.

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)

The free fractions of circulating docosahexaenoic acid and eicosapentenoic acid as optimal end-point of measure in bioavailability studies on n-3 fatty acids.

Science.gov (United States)

Scarsi, Claudia; Levesque, Ann; Lisi, Lucia; Navarra, Pierluigi

2015-05-01

The high complexity of n-3 fatty acids absorption process, along with the huge amount of endogenous fraction, makes bioavailability studies with these agents very challenging and deserving special consideration. In this paper we report the results of a bioequivalence study between a new formulation of EPA+DHA ethyl esters developed by IBSA Institut Biochimique and reference medicinal product present on the Italian market. Bioequivalence was demonstrated according to the criteria established by the EMA Guideline on the Investigation of Bioequivalence. We found that the free fractions represent a better and more sensitive end-point for bioequivalence investigations on n-3 fatty acids, since: (i) the overall and intra-subject variability of PK parameters was markedly lower compared to the same variability calculated on the total DHA and EPA fractions; (ii) the absorption process was completed within 4h, and the whole PK profile could be drawn within 12-15 h from drug administration. Copyright © 2014 Elsevier Ltd. All rights reserved.

Environment conservation by way of official notice or recommendations

International Nuclear Information System (INIS)

Ossenbuehl, F.

1986-01-01

Official notice or recommendations belong to the self-evident instruments of government authorities to fulfill their functions. According to their typical type of effect, in the system of powers to act, these instruments belong to the group of the simple administrative acts of state. They are thus not of direct legal interest, at first sight. However, the Chernobyl accident and its consequences have just been the latest opportunity to realise that official notice or recommendations issued by state authorities may have a far-reaching impact on the consumers' behaviour, and hence on the market situation. The book in hand discusses legal problems in connection with such impact, taking as an example the field of environment conservation and related precautionary activities. The main issues dealt with refer to the permissibility by law and the formal status of official notice warning of the use of environmentally harmful products, to legal protection in case of unlawful warnings or recommendations, and to possible liabilities. The book in hand developed from a legal expertise made on behalf of the German Federation of Toilet Articles and Detergents Producers is intended to show that the increasingly used informal administrative instruments of official notice or recommendations ought to be integrated into the system of administrative law. (orig./HP) [de

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.

Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report.

Science.gov (United States)

Chen, Mei-Ling; Shah, Vinod P; Ganes, Derek; Midha, Kamal K; Caro, James; Nambiar, Prabu; Rocci, Mario L; Thombre, Avinash G; Abrahamsson, Bertil; Conner, Dale; Davit, Barbara; Fackler, Paul; Farrell, Colm; Gupta, Suneel; Katz, Russell; Mehta, Mehul; Preskorn, Sheldon H; Sanderink, Gerard; Stavchansky, Salomon; Temple, Robert; Wang, Yaning; Winkle, Helen; Yu, Lawrence

2010-09-01

Modified-release (MR) products are complex dosage forms designed to release drug in a controlled manner to achieve the desired efficacy and safety profiles. Inappropriate control of drug release from such products may result in reduced efficacy or increased toxicity. This paper is a summary report of the American Association of Pharmaceutical Scientists, International Pharmaceutical Federation, and Product Quality Research Institute workshop titled "Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products", held October 1-2, 2009, in Baltimore, Maryland. The workshop provided an opportunity for pharmaceutical scientists from academia, industry, and regulatory agencies to discuss current regulatory expectations and industry practices for evaluating the pharmaceutical equivalence and bioequivalence of oral MR products. In the case of conventional monophasic MR formulations, the current regulatory approaches and criteria for bioequivalence evaluation were considered adequate for the assessment of therapeutic equivalence and inter-changeability of drug products. Additional measures may occasionally be needed to determine the bioequivalence of multiphasic MR products. The metric of partial AUC proposed by the US Food and Drug Administration received broad support as an additional measure for evaluating bioequivalence of multiphasic MR products designed to have a rapid onset of drug action followed by sustained response. The cutoff for partial AUCs may be based on the pharmacokinetic/pharmacodynamic or pharmacokinetic/ response characteristics of the products under examination. If the new metric is highly variable, the bioequivalence limits may be set based on the known within-subject variability for the reference product. The current regulatory approaches and criteria for bioequivalence evaluation were considered adequate for the assessment of therapeutic equivalence and

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...

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.

Adherence to WCRF/AICR cancer prevention recommendations and metabolic syndrome in breast cancer patients.

Science.gov (United States)

Bruno, Eleonora; Gargano, Giuliana; Villarini, Anna; Traina, Adele; Johansson, Harriet; Mano, Maria Piera; Santucci De Magistris, Maria; Simeoni, Milena; Consolaro, Elena; Mercandino, Angelica; Barbero, Maggiorino; Galasso, Rocco; Bassi, Maria Chiara; Zarcone, Maurizio; Zagallo, Emanuela; Venturelli, Elisabetta; Bellegotti, Manuela; Berrino, Franco; Pasanisi, Patrizia

2016-01-01

Metabolic syndrome (MetS), conventionally defined by the presence of at least three out of five dismetabolic traits (abdominal obesity, hypertension, low plasma HDL-cholesterol and high plasma glucose and triglycerides), has been associated with both breast cancer (BC) incidence and prognosis. We investigated the association between the prevalence of MetS and a score of adherence to the World Cancer Research Fund (WCRF) and American Institute for Cancer Research (AICR) recommendations for the prevention of cancer in a cross-sectional study of BC patients. The DIet and ANdrogen-5 study (DIANA-5) for the prevention of BC recurrences recruited 2092 early stage BC survivors aged 35-70. At recruitment, all women completed a 24-hour food frequency and physical activity diary on their consumption and activity of the previous day. Using these diaries we created a score of adherence to five relevant WCRF/AICR recommendations. The prevalence ratios (PRs) and 95% confidence intervals (CIs) of MetS associated with the number of recommendations met were estimated using a binomial regression model. The adjusted PRs of MetS decreased with increasing number of recommendations met (p < 0.001). Meeting all the five recommendations versus meeting none or only one was significantly associated with a 57% lower MetS prevalence (95% CI 0.35-0.73). Our results suggest that adherence to WCRF/AICR recommendations is a major determinant of MetS and may have a clinical impact. © 2015 UICC.

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.

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

Collaborative User Network Embedding for Social Recommender Systems

KAUST Repository

Zhang, Chuxu

2017-06-09

To address the issue of data sparsity and cold-start in recommender system, social information (e.g., user-user trust links) has been introduced to complement rating data for improving the performances of traditional model-based recommendation techniques such as matrix factorization (MF) and Bayesian personalized ranking (BPR). Although effective, the utilization of the explicit user-user relationships extracted directly from such social information has three main limitations. First, it is difficult to obtain explicit and reliable social links. Only a small portion of users indicate explicitly their trusted friends in recommender systems. Second, the “cold-start” users are “cold” not only on rating but also on socializing. There is no significant amount of explicit social information that can be useful for “cold-start” users. Third, an active user can be socially connected with others who have different taste/preference. Direct usage of explicit social links may mislead recommendation. To address these issues, we propose to extract implicit and reliable social information from user feedbacks and identify top-k semantic friends for each user. We incorporate the top-k semantic friends information into MF and BPR frameworks to solve the problems of ratings prediction and items ranking, respectively. The experimental results on three real-world datasets show that our proposed approaches achieve better results than the state-of-the-art MF with explicit social links (with 3.0% improvement on RMSE), and social BPR (with 9.1% improvement on AUC).

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...

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.

Participatory and evidence-based recommendations for urban redevelopment following natural disasters: older adults as policy advisers.

Science.gov (United States)

Annear, Michael; Keeling, Sally; Wilkinson, Tim

2014-03-01

To develop community-generated recommendations to inform urban environmental remediation following earthquakes in Christchurch, New Zealand, and share these with local decision-makers during a participatory action research process. This study employed three focus group discussions to critique mixed-methods and multiphase results and develop evidence-based recommendations. Participants included 30 volunteers and 8 knowledgeable advisers aged 65 years and older. Participant recommendations addressed the remediation of earthquake-affected suburbs, access to transportation, age-friendly design, safer communities, resilient support agencies, and restoration of resources for social and cultural activities. Older collaborators identified salient barriers to active ageing and options for post-earthquake redevelopment that had not previously been considered in research or policy. Independently living older adults are well placed to work with researchers to develop recommendations to improve the urban environment following natural disasters as well as in times of relative stability. © 2013 ACOTA.

A survey of exercise advice and recommendations in United Kingdom paediatric cardiac clinics.

Science.gov (United States)

Williams, Craig A; Gowing, Lucy; Horn, Richard; Stuart, Alan Graham

2017-07-01

Physical activity and exercise have important health benefits for children and adolescents with CHD. The objective of this study was to survey the provision of advice and recommendations in United Kingdom paediatric CHD clinics. A three-page questionnaire was sent out to paediatric cardiac consultants in the United Kingdom, paediatric consultants with expertise in cardiology, and nursing staff (Paediatricians with Expertise in Cardiology Special Interest Group), as well as all members of the British Congenital Cardiovascular Association. The aim of this questionnaire was to determine the extent and scope of current information provision and to assess the importance that clinicians place on this advice. There were 68 responses in total, and the data showed that, of these, 24 (36%) clinicians had never provided paediatric CHD patients with written advice about exercise. Only 27 (39%) clinicians provided physical activity advice at every appointment. Lack of time during consultation (n=39, 56.9%), lack of training (n=38, 55.2%), and uncertainty about appropriate recommendations (n=38, 55.2%) were identified as the main factors preventing clinicians from providing patients with advice about physical activity. Although healthcare providers consider physical activity to be very important, the provision of clear, specific advice and recommendations is underutilised; therefore, more education and provision of resources to support the promotion of exercise need to be provided to clinicians and their support teams.

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

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

INCOG recommendations for management of cognition following traumatic brain injury, part II: attention and information processing speed.

Science.gov (United States)

Ponsford, Jennie; Bayley, Mark; Wiseman-Hakes, Catherine; Togher, Leanne; Velikonja, Diana; McIntyre, Amanda; Janzen, Shannon; Tate, Robyn

2014-01-01

Traumatic brain injury, due to its diffuse nature and high frequency of injury to frontotemporal and midbrain reticular activating systems, may cause disruption in many aspects of attention: arousal, selective attention, speed of information processing, and strategic control of attention, including sustained attention, shifting and dividing of attention, and working memory. An international team of researchers and clinicians (known as INCOG) convened to develop recommendations for the management of attentional problems. The experts selected recommendations from published guidelines and then reviewed literature to ensure that recommendations were current. Decision algorithms incorporating the recommendations based on inclusion and exclusion criteria of published trials were developed. The team then prioritized recommendations for implementation and developed audit criteria to evaluate adherence to these best practices. The recommendations and discussion highlight that metacognitive strategy training focused on functional everyday activities is appropriate. Appropriate use of dual task training, environmental modifications, and cognitive behavioral therapy is also discussed. There is insufficient evidence to support mindfulness meditation and practice on de-contextualized computer-based tasks for attention. Administration of the medication methylphenidate should be considered to improve information-processing speed. The INCOG recommendations for rehabilitation of attention provide up-to-date guidance for clinicians treating people with traumatic brain injury.

Competence Description for Personal Recommendations: The Importance of Identifying the Complexity of Learning and Performance Situations

Science.gov (United States)

Prins, Frans J.; Nadolski, Rob J.; Berlanga, Adriana J.; Drachsler, Hendrik; Hummel, Hans G. K.; Koper, Rob

2008-01-01

For competences development of learners and professionals, target competences and corresponding competence development opportunities have to be identified. Personal Recommender Systems (PRS) provide personal recommendations for learners aimed at finding and selecting learning activities that best match their needs. This article argues that a…

Developing a new formulation of sodium phenylbutyrate.

Science.gov (United States)

Guffon, Nathalie; Kibleur, Yves; Copalu, William; Tissen, C; Breitkreutz, Joerg

2012-12-01

Sodium phenylbutyrate (NaPB) is used as a treatment for urea cycle disorders (UCD). However, the available, licensed granule form has an extremely bad taste, which can compromise compliance and metabolic control. A new, taste-masked, coated-granule formulation (Luc 01) under development was characterised for its in vitro taste characteristics, dissolution profiles and bioequivalence compared with the commercial product. Taste, safety and tolerability were also compared in healthy adult volunteers. The in vitro taste profile of NaPB indicated a highly salty and bitter tasting molecule, but Luc 01 released NaPB only after a lag time of ∼10 s followed by a slow release over a few minutes. In contrast, the licensed granules released NaPB immediately. The pharmacokinetic study demonstrated the bioequivalence of a single 5 g dose of the two products in 13 healthy adult volunteers. No statistical difference was seen either for maximal plasma concentration (C(max)) or for area under the plasma concentration-time curve (AUC). CI for C(max) and AUC(0-inf) of NaPB were included in the bioequivalence range of 0.80-1.25. One withdrawal for vomiting and five reports of loss of taste perception (ageusia) were related to the licensed product. Acceptability, bitterness and saltiness assessed immediately after administration indicated a significant preference for Luc 01 (p<0.01), confirming the results of the taste prediction derived from in vitro measurements. In vitro dissolution, in vitro and in vivo taste profiles support the view that the newly developed granules can be swallowed before release of the bitter active substance, thus avoiding stimulation of taste receptors. Moreover, Luc 01 was shown to be bioequivalent to the licensed product. The availability of a taste-masked form should improve compliance which is critical to the efficacy of NaPB treatment in patients with UCD.

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.

Fires involving radioactive materials : transference model; operative recommendations

International Nuclear Information System (INIS)

Rodriguez, C.E.; Puntarulo, L.J.; Canibano, J.A.

1988-01-01

In all aspects related to the nuclear activity, the occurrence of an explosion, fire or burst type accident, with or without victims, is directly related to the characteristics of the site. The present work analyses the different parameters involved, describing a transference model and recommendations for evaluation and control of the radiological risk for firemen. Special emphasis is placed on the measurement of the variables existing in this kind of operations

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

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

Coalbed methane multi-stakeholder advisory committee recommendations : progress update : year 3

International Nuclear Information System (INIS)

2009-11-01

The coalbed methane (CBM) multi-stakeholder advisory committee (MAC) was formed in 2003 to address public concerns related to CBM development in Alberta. This progress update discussed activities and recommendations made by the MAC, with particular reference to the following 4 main areas: (1) protecting water resources, (2) enhancing information and knowledge, (3) minimizing surface impacts, and (4) communication and consultation. A second MAC was formed by members from environmental organizations, landowners, the energy industry, and government agencies in 2006 to review progress on the implementation of the recommendations. Members of the committee agree that significant progress has been achieved in relation to the recommendations made by the original MAC. A large number of new directives, guidelines, processes and best management practices have been established, or are currently under development. Approximately 19,000 CBM wells have been developed since the MAC was established in 2003. It was concluded that ongoing work related to the recommendations will ensure that CBM in Alberta continues to be developed in a responsible manner. 1 tab.

Contemporary operative caries management: consensus recommendations on minimally invasive caries removal

NARCIS (Netherlands)

Banerjee, A.; Frencken, J.E.F.M.; Schwendicke, F.; Innes, N.P.

2017-01-01

The International Caries Consensus Collaboration (ICCC) presented recommendations on terminology, on carious tissue removal and on managing cavitated carious lesions. It identified 'dental caries' as the name of the disease that dentists should manage, and the importance of controlling the activity

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.

An effective trust-based recommendation method using a novel graph clustering algorithm

Science.gov (United States)

Moradi, Parham; Ahmadian, Sajad; Akhlaghian, Fardin

2015-10-01

Recommender systems are programs that aim to provide personalized recommendations to users for specific items (e.g. music, books) in online sharing communities or on e-commerce sites. Collaborative filtering methods are important and widely accepted types of recommender systems that generate recommendations based on the ratings of like-minded users. On the other hand, these systems confront several inherent issues such as data sparsity and cold start problems, caused by fewer ratings against the unknowns that need to be predicted. Incorporating trust information into the collaborative filtering systems is an attractive approach to resolve these problems. In this paper, we present a model-based collaborative filtering method by applying a novel graph clustering algorithm and also considering trust statements. In the proposed method first of all, the problem space is represented as a graph and then a sparsest subgraph finding algorithm is applied on the graph to find the initial cluster centers. Then, the proposed graph clustering algorithm is performed to obtain the appropriate users/items clusters. Finally, the identified clusters are used as a set of neighbors to recommend unseen items to the current active user. Experimental results based on three real-world datasets demonstrate that the proposed method outperforms several state-of-the-art recommender system methods.

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.

Maximum tolerable radiation doses recommended by the Israel Advisory Committee on nuclear safety

International Nuclear Information System (INIS)

Tadmor, J.; Litai, D.; Lubin, E.

1978-01-01

Maximum tolerable doses have been recommended by the Israel Advisory Committee on Nuclear Safety. The recommendations which are based on a comparison with risks tolerated in other human activities, are for doses to radiation workers, for individual members of the population at the fence of a nuclear installation, and for the population at large, for both normal operating and accident conditions. Tolerable whole-body doses and doses to different critical organs are listed

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.

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 ...

Quality Dimensions, Value, Service Cost and Recommendation Behaviour: Evidence from the Nigerian Cellular Industry

Directory of Open Access Journals (Sweden)

Abolaji Joachim Abiodun

2014-09-01

Full Text Available The present study proposed and test a model that connects both affective and cognitive factors in cellular service to customers’ recommendation behavior. Results of the analysis of data collected through questionnaire from 293 respondents with cellular phones and active account in the Nigerian cellular industry indicate that core cellular service dimensions, service cost (price and hedonic values are significant determinants of customers’ recommendation behavior. In addition, the study found that customer service and utilitarian value exert negative effect on recommendation behavior. It seems that strengthening the performance of service providers on core service attributes, service cost (price and the entertainment and emotion evoking aspects of cellular service is of more value in partnering with customer to enlarge customer base through recommendation

Personalized Location-Based Recommendation Services for Tour Planning in Mobile Tourism Applications

Science.gov (United States)

Yu, Chien-Chih; Chang, Hsiao-Ping

Travel and tour planning is a process of searching, selecting, grouping and sequencing destination related products and services including attractions, accommodations, restaurants, and activities. Personalized recommendation services aim at suggesting products and services to meet users’ preferences and needs, while location-based services focus on providing information based on users’ current positions. Due to the fast growing of user needs in the mobile tourism domain, how to provide personalized location-based tour recommendation services becomes a critical research and practical issue. The objective of this paper is to propose a system architecture and design methods for facilitating the delivery of location-based recommendation services to support personalized tour planning. Based on tourists’ current location and time, as well as personal preferences and needs, various recommendations regarding sightseeing spots, hotels, restaurants, and packaged tour plans can be generated efficiently. An application prototype is also implemented to illustrate and test the system feasibility and effectiveness.

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.

Physical activity and cardiovascular risk factors in children

DEFF Research Database (Denmark)

Andersen, Lars Bo; Riddoch, Chris; Kriemler, Susi

2011-01-01

A number of recent systematic reviews have resulted in changes in international recommendations for children's participation in physical activity (PA) for health. The World Health Authority (WHO) has recently released new recommendations. The WHO still recommends 60 min of moderate to vigorous...... physical activity (MVPA), but also emphasises that these minutes should be on top of everyday physical activities. Everyday physical activities total around 30 min of MVPA in the quintile of the least active children, which means that the new recommendations constitute more activity in total compared...

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.

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...

Interest Aware Location-Based Recommender System Using Geo-Tagged Social Media

Directory of Open Access Journals (Sweden)

Basma AlBanna

2016-12-01

Full Text Available Advances in location acquisition and mobile technologies led to the addition of the location dimension to Social Networks (SNs and to the emergence of a newer class called Location-Based Social Networks (LBSNs. While LBSNs are richer in their model and functions than SNs, they fail so far to attract as many users as SNs. On the other hand, SNs have large amounts of geo-tagged media that are under-utilized. In this paper, we propose an Interest-Aware Location-Based Recommender system (IALBR, which combines the advantages of both LBSNs and SNs, in order to provide interest-aware location-based recommendations. This recommender system is proposed as an extension to LBSNs. It is novel in: (1 utilizing the geo-content in both LBSNs and SNs; (2 ranking the recommendations based on a novel scoring method that maps to the user interests. It also works for passive users who are not active content contributors to the LBSN. This feature is critical to increase the number of LBSN users. Moreover, it helps with reducing the cold start problem, which is a common problem facing the new users of recommender systems who get random unsatisfying recommendations. This is due to the lack of user interest awareness, which is reliant on user history in most of the recommenders. We evaluated our system with a large-scale real dataset collected from foursquare with respect to precision, recall and the f-measure. We also compared the results with a ground truth system using metrics like the normalized discounted cumulative gain and the mean absolute error. The results confirm that the proposed IALBR generates more efficient recommendations than baselines in terms of interest awareness.

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.)

Recommendations and Suggestions of the IRRS Mission in Croatia

International Nuclear Information System (INIS)

Novosel, N.

2016-01-01

According to the Act on Radiological and Nuclear Safety, Director General of the State Office for Radiological and Nuclear Safety (SORNS) is obliged to conduct self-assessment of the national legislative framework and of the competent authorities and to provide for international audit of important segments of the national legislative framework and competent authorities with the purpose of continuous improvement of radiological and nuclear safety. SORNS as a state administration body competent for activities pertaining to radiological and nuclear safety, submitted in April 2013 the request to the International Atomic Energy Agency (IAEA) to conduct an Integrated Regulatory Review Service (IRRS) mission. SORNS conducted a self-assessment in preparation for the mission and prepared a preliminary action plan. The results of SORNS self-assessment and supporting documentation were provided to the IRRS review team as advance reference material for the mission. IRRS mission took place in Zagreb from 7 to 17 Jun 2015. The IRRS team carried out the review in the following areas: responsibilities and functions of the government; the global nuclear safety regime; responsibilities and functions of the regulatory body; the management system of the regulatory body; the activities of the regulatory body including authorization, review and assessment, inspection and enforcement processes; development and content of regulations and guides; emergency preparedness and response; occupational radiation protection, patient protection, public and environmental exposure control, waste management and decommissioning. The IRRS team identified a number of recommendations and suggestions where improvements in the area of radiological and nuclear safety are necessary or desirable. Those recommendations and suggestions were translated and approved by the Government in the form of the Governmental conclusion. This conclusion presents the action plan for the SORNS and other governmental bodies and

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...

A Fast Recommender System for Cold User Using Categorized Items

Directory of Open Access Journals (Sweden)

Hamid Jazayeriy

2018-01-01

Full Text Available In recent years, recommender systems (RS provide a considerable progress to users. RSs reduce the cost of a user’s time in order to reach to desired results faster. The main issue of RSs is the presence of cold users which are less active and their preferences are more difficult to detect. The aim of this study is to provide a new way to improve recall and precision in recommender systems for cold users. According to the available categories of items, prioritization of the proposed items is improved and then presented to the cold user. The obtained results show that in addition to increased speed of processing, recall and precision have an acceptable improvement.

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.

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.

Nuclear Security Recommendations on Radioactive Material and Associated Facilities: Recommendations (Spanish Edition); Recomendaciones de Seguridad Fisica Nuclear sobre Materiales Radiactivos e Instalaciones Conexas: Recomendaciones

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-06-15

The purpose of this publication is to provide guidance to States and competent authorities on how to develop or enhance, implement and maintain a nuclear security regime for facilities dealing with radioactive material and associated activities. This is to be achieved through the establishment or improvement of their capabilities to implement a legislative and regulatory framework to address the security of radioactive material, associated facilities and associated activities in order to reduce the likelihood of malicious acts involving those materials. These recommendations reflect a broad consensus among States on the requirements which should be met for the security of radioactive material, associated facilities and activities.

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

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...

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...

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...

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

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

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...

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.

Adrenal incidentaloma in adults - management recommendations by the Polish Society of Endocrinology.

Science.gov (United States)

Bednarczuk, Tomasz; Bolanowski, Marek; Sworczak, Krzysztof; Górnicka, Barbara; Cieszanowski, Andrzej; Otto, Maciej; Ambroziak, Urszula; Pachucki, Janusz; Kubicka, Eliza; Babińska, Anna; Koperski, Łukasz; Januszewicz, Andrzej; Prejbisz, Aleksander; Górska, Maria; Jarząb, Barbara; Hubalewska-Dydejczyk, Alicja; Glinicki, Piotr; Ruchała, Marek; Kasperlik-Załuska, Anna

2016-01-01

A wide use of imaging techniques results in more frequent diagnosis of adrenal incidenataloma. To analyse the current state of knowledge on adrenal incidentaloma in adults in order to prepare practical management recommendations. Following a discussion, the Polish Society of Endocrinology expert working group have analysed the available data and summarised the analysis results in the form of recommendations. Unenhanced adrenal computed tomography (CT) may be recommended as an initial assessment examination helpful in the differentiation between adenomas and "non-adenomatous" lesions. In the case of density > 10 Hounsfield units, CT with contrast medium washout assessment or MRI are recommended. However, in all patients with adrenal incidentaloma, hormonal assessment is recommended in order to exclude pheochromocytoma and hypercortisolism, notwithstanding the clinical picture or concomitant diseases. In addition, examination to exclude primary hyperaldosteronism is suggested in patients with diagnosed hypertension or hypokalaemia. Surgical treatment should be recommended in patients with adrenal incidentaloma, where imaging examinations suggest a malignant lesion (oncological indication) or with confirmed hormonal activity (endocrinological indication). The basis of the surgical treatment is laparoscopic adrenalectomy. Patients with suspected pheochromocytoma must be pharmacologically prepared prior to surgery. In patients not qualified for surgery, control examinations (imaging and laboratory tests) should be established individually, taking into consideration such features as the size, image, and growth dynamics of the tumour, clinical symptoms, hormonal tests results, and concomitant diseases.

Implications of draft ICRP recommendations: the View of the OECD Nuclear Energy Agency

International Nuclear Information System (INIS)

Magnusson, S.; Lazo, T.

2006-01-01

Full text: The OECD Nuclear Energy Agency has taken an active interest in the work being performed by the International Commission on Radiological Protection (ICRP) to develop a new set of general recommendations. As several key junctures, the Nea, through the lead of its Committee on Radiation Protection and Public Health (C.R.P.P.H.) has performed in-depth analyses of the possible implications that draft ICRP materials, in order to inform policy makers of the regulatory and application implications that would result should draft ICRP Recommendations for a system of radiological protection be published. Comments from the Nea have constructively contributed to the ICRP development process, and it is hoped that the final ICRP recommendations in this area will be developed to best serve the needs of national and international radiation protection policy makers, regulators and implementers. Having assessed and commented on previous drafts, the C.R.P.P.H. has co-ordinated the views of all the relevant standing technical committees within the OECD Nuclear Energy Agency to provide constructive suggestions as to how the text could be usefully improved. Comments were requested from the Nea committees dealing with radioactive waste management, nuclear safety, nuclear regulatory activities, nuclear development and nuclear science. The present paper summarises the results of the C.R.P.P.H. review process related to the new ICRP recommendations. (author)

DEVELOPMENT OF FRANCHISING IN CROATIA OBSTACLES AND POLICY RECOMMENDATIONS

Directory of Open Access Journals (Sweden)

Mirela Alpeza

2015-11-01

Full Text Available Franchising is very popular growth model but despite the wide application of franchising in the developed countries of the world, its impact on the Croatian economy is still marginal. The purpose of this research is to identify the obstacles and challenges to a wider application of franchising in Croatia and generate policy recommendations for removing the identified obstacles. Obstacles and recommendations are identified on the basis of a conducted longitudinal qualitative research, the first phase of which was conducted in 2006, and second in 2014. The overall results of this research were presented in a form of PEST analysis and compared with the results of the 2006 research aiming to detect changes (improvements/ deterioration in individual areas of the research political, economic, legal and technologic factors of influence on the development of franchising in Croatia. Based on the detected changes, conclusions and policy recommendations were identified.The obstacles can be divided in two categories: franchising specific barriers and general business related obstacles for doing business in Croatia. Without removing most of these obstacles, it is unrealistic to expect high growth of franchising activities in Croatia in near future.

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.

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...

75 FR 20599 - Proposed Data Collections Submitted for Public Comment and Recommendations

Science.gov (United States)

2010-04-20

..., diabetes, high blood pressure, high cholesterol, obesity, smoking, drug and alcohol use, physical activity...; private groups such as the American Heart Association; schools of public health; private businesses... recommended dietary allowances, food fortification policies, environmental exposures, immunization guidelines...

Recommendations service for chronic disease patient in multimodel sensors home environment.

Science.gov (United States)

Hussain, Maqbool; Ali, Taqdir; Khan, Wajahat Ali; Afzal, Muhammad; Lee, Sungyoung; Latif, Khalid

2015-03-01

With advanced technologies in hand, there exist potential applications and services built around monitoring activities of daily living (ADL) of elderly people at nursing homes. Most of the elderly people in these facilities are suffering from different chronic diseases such as dementia. Existing technologies are mainly focusing on non-medication interventions and monitoring of ADL for addressing loss of autonomy or well-being. Monitoring and managing ADL related to cognitive behaviors for non-medication intervention are very effective in improving dementia patients' conditions. However, cognitive functions of patients can be improved if appropriate recommendations of medications are delivered at a particular time. Previously we developed the Secured Wireless Sensor Network Integrated Cloud Computing for Ubiquitous-Life Care (SC(3)). SC(3) services were limited to monitoring ADL of elderly people with Alzheimer's disease and providing non-medication recommendations to the patient. In this article, we propose a system called the Smart Clinical Decision Support System (CDSS) as an integral part of the SC(3) platform. Using the Smart CDSS, patients are provided with access to medication recommendations of expert physicians. Physicians are provided with an interface to create clinical knowledge for medication recommendations and to observe the patient's condition. The clinical knowledge created by physicians as the knowledge base of the Smart CDSS produces recommendations to the caregiver for medications based on each patient's symptoms.

Uncovering the information core in recommender systems

Science.gov (United States)

Zeng, Wei; Zeng, An; Liu, Hao; Shang, Ming-Sheng; Zhou, Tao

2014-08-01

With the rapid growth of the Internet and overwhelming amount of information that people are confronted with, recommender systems have been developed to effectively support users' decision-making process in online systems. So far, much attention has been paid to designing new recommendation algorithms and improving existent ones. However, few works considered the different contributions from different users to the performance of a recommender system. Such studies can help us improve the recommendation efficiency by excluding irrelevant users. In this paper, we argue that in each online system there exists a group of core users who carry most of the information for recommendation. With them, the recommender systems can already generate satisfactory recommendation. Our core user extraction method enables the recommender systems to achieve 90% of the accuracy of the top-L recommendation by taking only 20% of the users into account. A detailed investigation reveals that these core users are not necessarily the large-degree users. Moreover, they tend to select high quality objects and their selections are well diversified.

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 ...

On the improvement of IT process maturity: assessment, recommendation and validation

Directory of Open Access Journals (Sweden)

Dirgahayu Teduh

2018-01-01

Full Text Available The use of information technology (IT in enterprises must be governed and managed appropriately using IT processes. The notion of IT process maturity is useful to measure the actual performance and to define the desired performance of IT processes. Improvements are necessary when there are gaps between the actual and desired performance. Most literatures focus on IT process maturity assessment. They do not address how to improve IT process maturity. This paper proposes an approach to enterprise IT process maturity improvement for COBIT processes. The approach consists of three activities, i.e. IT process maturity assessment, recommendation, and validation. Assessment is to recognise the process’ control objectives maturity. From the assessment results, recommendation identifies control objectives that must be improved and then suggests improvement actions. The prescriptive nature of the control objectives facilitates in suggesting those actions. Recommendations for managements are defined by abstracting similar actions. Validation checks whether the recommendations match with the enterprise needs and capability. It includes a scale for validation, in which enterprise’s capability is categorized into (i not capable, (ii capable with great efforts, and (iii fully capable. The paper illustrates the approach with a case study.

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...

Minimizing liability risks under the ACMG recommendations for reporting incidental findings in clinical exome and genome sequencing

Science.gov (United States)

Evans, Barbara J.

2014-01-01

Recent recommendations by the American College of Medical Genetics and Genomics (ACMG) for reporting incidental findings present novel ethical and legal issues. This article expresses no views on the ethical aspects of these recommendations and focuses strictly on liability risks and how to minimize them. The recommendations place labs and clinicians in a new liability environment that exposes them to intentional tort lawsuits as well to traditional suits for negligence. Intentional tort suits are especially troubling because of their potential to inflict ruinous personal financial losses on individual clinicians and laboratory personnel. This article surveys this new liability landscape and describes analytical approaches for minimizing tort liabilities. To a considerable degree, liability risks can be controlled by structuring activities in ways that make future lawsuits nonviable before the suits ever arise. Proactive liability analysis is an effective tool for minimizing tort liabilities in connection with the testing and reporting activities that the ACMG recommends. PMID:24030435

Minimizing liability risks under the ACMG recommendations for reporting incidental findings in clinical exome and genome sequencing.

Science.gov (United States)

Evans, Barbara J

2013-12-01

Recent recommendations by the American College of Medical Genetics and Genomics (ACMG) for reporting incidental findings present novel ethical and legal issues. This article expresses no views on the ethical aspects of these recommendations and focuses strictly on liability risks and how to minimize them. The recommendations place labs and clinicians in a new liability environment that exposes them to intentional tort lawsuits as well to traditional suits for negligence. Intentional tort suits are especially troubling because of their potential to inflict ruinous personal financial losses on individual clinicians and laboratory personnel. This article surveys this new liability landscape and describes analytical approaches for minimizing tort liabilities. To a considerable degree, liability risks can be controlled by structuring activities in ways that make future lawsuits nonviable before the suits ever arise. Proactive liability analysis is an effective tool for minimizing tort liabilities in connection with the testing and reporting activities that the ACMG recommends.

Recommendations for accreditation of laboratories in molecular biology of hematologic malignancies.

Science.gov (United States)

Flandrin-Gresta, Pascale; Cornillet, Pascale; Hayette, Sandrine; Gachard, Nathalie; Tondeur, Sylvie; Mauté, Carole; Cayuela, Jean-Michel

2015-01-01

Over recent years, the development of molecular biology techniques has improved the hematological diseases diagnostic and follow-up. Consequently, these techniques are largely used in the biological screening of these diseases; therefore the Hemato-oncology molecular diagnostics laboratories must be actively involved in the accreditation process according the ISO 15189 standard. The French group of molecular biologists (GBMHM) provides requirements for the implementation of quality assurance for the medical molecular laboratories. This guideline states the recommendations for the pre-analytical, analytical (methods validation procedures, quality controls, reagents), and post-analytical conditions. In addition, herein we state a strategy for the internal quality control management. These recommendations will be regularly updated.

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…

Uptake of recommended common reference intervals for chemical pathology in Australia.

Science.gov (United States)

Jones, Graham Rd; Koetsier, Sabrina

2017-05-01

Background Reference intervals are a vital part of reporting numerical pathology results. It is known, however, that variation in reference intervals between laboratories is common, even when analytical methods support common reference intervals. In response to this, in Australia, the Australasian Association of Clinical Biochemists together with the Royal College of Pathologists of Australasia published in 2014 a set of recommended common reference intervals for 11 common serum analytes (sodium, potassium, chloride, bicarbonate, creatinine male, creatinine female, calcium, calcium adjusted for albumin, phosphate, magnesium, lactate dehydrogenase, alkaline phosphatase and total protein). Methods Uptake of recommended common reference intervals in Australian laboratories was assessed using data from four annual cycles of the RCPAQAP reference intervals external quality assurance programme. Results Over three years, from 2013 to 2016, the use of the recommended upper and lower reference limits has increased from 40% to 83%. Nearly half of the intervals in use by enrolled laboratories in 2016 have been changed in this time period, indicating an active response to the guidelines. Conclusions These data support the activities of the Australasian Association of Clinical Biochemists and Royal College of Pathologists of Australasia in demonstrating a change in laboratory behaviour to reduce unnecessary variation in reference intervals and thus provide a consistent message to doctor and patients irrespective of the laboratory used.

From recommendation to action: psychosocial factors influencing physician intention to use Health Technology Assessment (HTA recommendations

Directory of Open Access Journals (Sweden)

Sánchez Emília

2006-03-01

Full Text Available Abstract Background Evaluating the impact of recommendations based upon health technology assessment (HTA represents a challenge for both HTA agencies and healthcare policy-makers. Using a psychosocial theoretical framework, this study aimed at exploring the factors affecting physician intention to adopt HTA recommendations. The selected recommendations were prioritisation systems for patients on waiting lists for two surgical procedures: hip and knee replacement and cataract surgery. Methods Determinants of physician intention to use HTA recommendations for patient prioritisation were assessed by a questionnaire based upon the Theory of Interpersonal Behaviour. A total of 96 physicians from two medical specialties (ophthalmology and orthopaedic surgery responded to the questionnaire (response rate 44.2%. A multiple analysis of variance (MANOVA was performed to assess differences between medical specialties on the set of theoretical variables. Given the main effect difference between specialties, two regression models were tested separately to assess the psychosocial determinants of physician intention to use HTA recommendations for the prioritisation of patients on waiting lists for surgical procedures. Results Factors influencing physician intention to use HTA recommendations differ between groups of specialists. Intention to use the prioritisation system for patients on waiting lists for cataract surgery among ophthalmologists was related to attitude towards the behaviour, social norms, as well as personal normative beliefs. Intention to use HTA recommendations for patient prioritisation for hip and knee replacement among orthopaedic surgeons was explained by: perception of conditions that facilitated the realisation of the behaviour, personal normative beliefs, and habit of using HTA recommendations in clinical work. Conclusion This study offers a model to assess factors influencing the intention to adopt recommendations from health

Physiotherapy in the intensive care unit: an evidence-based, expert driven, practical statement and rehabilitation recommendations

Science.gov (United States)

Sommers, Juultje; Engelbert, Raoul HH; Dettling-Ihnenfeldt, Daniela; Gosselink, Rik; Spronk, Peter E; Nollet, Frans; van der Schaaf, Marike

2015-01-01

Objective: To develop evidence-based recommendations for effective and safe diagnostic assessment and intervention strategies for the physiotherapy treatment of patients in intensive care units. Methods: We used the EBRO method, as recommended by the ‘Dutch Evidence Based Guideline Development Platform’ to develop an ‘evidence statement for physiotherapy in the intensive care unit’. This method consists of the identification of clinically relevant questions, followed by a systematic literature search, and summary of the evidence with final recommendations being moderated by feedback from experts. Results: Three relevant clinical domains were identified by experts: criteria to initiate treatment; measures to assess patients; evidence for effectiveness of treatments. In a systematic literature search, 129 relevant studies were identified and assessed for methodological quality and classified according to the level of evidence. The final evidence statement consisted of recommendations on eight absolute and four relative contra-indications to mobilization; a core set of nine specific instruments to assess impairments and activity restrictions; and six passive and four active effective interventions, with advice on (a) physiological measures to observe during treatment (with stopping criteria) and (b) what to record after the treatment. Conclusions: These recommendations form a protocol for treating people in an intensive care unit, based on best available evidence in mid-2014. PMID:25681407

Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee.

Science.gov (United States)

Lichtenstein, Alice H; Appel, Lawrence J; Brands, Michael; Carnethon, Mercedes; Daniels, Stephen; Franch, Harold A; Franklin, Barry; Kris-Etherton, Penny; Harris, William S; Howard, Barbara; Karanja, Njeri; Lefevre, Michael; Rudel, Lawrence; Sacks, Frank; Van Horn, Linda; Winston, Mary; Wylie-Rosett, Judith

2006-07-04

Improving diet and lifestyle is a critical component of the American Heart Association's strategy for cardiovascular disease risk reduction in the general population. This document presents recommendations designed to meet this objective. Specific goals are to consume an overall healthy diet; aim for a healthy body weight; aim for recommended levels of low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides; aim for normal blood pressure; aim for a normal blood glucose level; be physically active; and avoid use of and exposure to tobacco products. The recommendations are to balance caloric intake and physical activity to achieve and maintain a healthy body weight; consume a diet rich in vegetables and fruits; choose whole-grain, high-fiber foods; consume fish, especially oily fish, at least twice a week; limit intake of saturated fat to foods with added sugars; choose and prepare foods with little or no salt; if you consume alcohol, do so in moderation; and when you eat food prepared outside of the home, follow these Diet and Lifestyle Recommendations. By adhering to these diet and lifestyle recommendations, Americans can substantially reduce their risk of developing cardiovascular disease, which remains the leading cause of morbidity and mortality in the United States.

Recommendations on basic requirements for intensive care units: structural and organizational aspects.

Science.gov (United States)

Valentin, Andreas; Ferdinande, Patrick

2011-10-01

To provide guidance and recommendations for the planning or renovation of intensive care units (ICUs) with respect to the specific characteristics relevant to organizational and structural aspects of intensive care medicine. The Working Group on Quality Improvement (WGQI) of the European Society of Intensive Care Medicine (ESICM) identified the basic requirements for ICUs by a comprehensive literature search and an iterative process with several rounds of consensus finding with the participation of 47 intensive care physicians from 23 countries. The starting point of this process was an ESICM recommendation published in 1997 with the need for an updated version. The document consists of operational guidelines and design recommendations for ICUs. In the first part it covers the definition and objectives of an ICU, functional criteria, activity criteria, and the management of equipment. The second part deals with recommendations with respect to the planning process, floorplan and connections, accommodation, fire safety, central services, and the necessary communication systems. This document provides a detailed framework for the planning or renovation of ICUs based on a multinational consensus within the ESICM.

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.

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.

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.)

Therapy Decision Support Based on Recommender System Methods.

Science.gov (United States)

Gräßer, Felix; Beckert, Stefanie; Küster, Denise; Schmitt, Jochen; Abraham, Susanne; Malberg, Hagen; Zaunseder, Sebastian

2017-01-01

We present a system for data-driven therapy decision support based on techniques from the field of recommender systems. Two methods for therapy recommendation, namely, Collaborative Recommender and Demographic-based Recommender , are proposed. Both algorithms aim to predict the individual response to different therapy options using diverse patient data and recommend the therapy which is assumed to provide the best outcome for a specific patient and time, that is, consultation. The proposed methods are evaluated using a clinical database incorporating patients suffering from the autoimmune skin disease psoriasis. The Collaborative Recommender proves to generate both better outcome predictions and recommendation quality. However, due to sparsity in the data, this approach cannot provide recommendations for the entire database. In contrast, the Demographic-based Recommender performs worse on average but covers more consultations. Consequently, both methods profit from a combination into an overall recommender system.

12 CFR 13.4 - Recommendations to customers.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 1 2010-01-01 2010-01-01 false Recommendations to customers. 13.4 Section 13.4... PRACTICES § 13.4 Recommendations to customers. In recommending to a customer the purchase, sale or exchange... reasonable grounds for believing that the recommendation is suitable for the customer upon the basis of the...

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.

Therapy Decision Support Based on Recommender System Methods

Directory of Open Access Journals (Sweden)

Felix Gräßer

2017-01-01

Full Text Available We present a system for data-driven therapy decision support based on techniques from the field of recommender systems. Two methods for therapy recommendation, namely, Collaborative Recommender and Demographic-based Recommender, are proposed. Both algorithms aim to predict the individual response to different therapy options using diverse patient data and recommend the therapy which is assumed to provide the best outcome for a specific patient and time, that is, consultation. The proposed methods are evaluated using a clinical database incorporating patients suffering from the autoimmune skin disease psoriasis. The Collaborative Recommender proves to generate both better outcome predictions and recommendation quality. However, due to sparsity in the data, this approach cannot provide recommendations for the entire database. In contrast, the Demographic-based Recommender performs worse on average but covers more consultations. Consequently, both methods profit from a combination into an overall recommender system.

Recommendation strategies for e-learning: preliminary effects of a personal recommender system for lifelong learners

NARCIS (Netherlands)

Drachsler, Hendrik; Hummel, Hans; Van den Berg, Bert; Eshuis, Jannes; Berlanga, Adriana; Nadolski, Rob; Waterink, Wim; Boers, Nanda; Koper, Rob

2007-01-01

Drachsler, H., Hummel, H. G. K., Van den Berg, B., Eshuis, J., Berlanga, A. J., Nadolski, R. J., Waterink, W., Boers, N., & Koper, R. (2007). Recommendation strategies for e-learning: preliminary effects of personal recommender system for lifelong learners. Unpublished manuscript.

Announcement of recommendations of the Reaktor-Sicherheitskommission. As of 24 July 1997. Joint recommendations of RSK and GPR for safety requirements of future nuclear PWR-type power plants. English versions published in the years 1995 through 1997