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Sample records for bioequivalence recommendations active

  1. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Science.gov (United States)

    2013-11-06

    ... Recommendations for Iron Sucrose; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific guidance... iron sucrose injection. The draft guidance is a revised version of a previously issued draft...

  2. 77 FR 58399 - Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium...

    Science.gov (United States)

    2012-09-20

    ... Recommendations for Pentosan Polysulfate Sodium Capsule; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Bioequivalence Recommendations for Pentosan Polysulfate Sodium.'' The... drug applications (ANDAs) for pentosan polysulfate sodium capsule. DATES: Although you can comment...

  3. 77 FR 18827 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection...

    Science.gov (United States)

    2012-03-28

    ... Recommendations for Iron Sucrose Injection; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific...) for iron sucrose injection. DATES: Although you can comment on any guidance at any time (see 21 CFR...

  4. 77 FR 7586 - Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray...

    Science.gov (United States)

    2012-02-13

    ... 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence...

  5. 77 FR 10535 - Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations...

    Science.gov (United States)

    2012-02-22

    ... FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence... Meprobamate Methotrexate Sodium (multiple RLDs) Methylprednisolone Acetate Metoclopramide HCl N Nadolol... Tosylate T Tamoxifen Citrate Telbivudine Temazepam Terbinafine HCl Toremifene Citrate V Voriconazole...

  6. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability

    Science.gov (United States)

    2012-11-06

    ... 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence...), approved by FDA on December 27, 2005, is a thalidomide analogue indicated for the treatment of:...

  7. Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products.

    Science.gov (United States)

    Choi, Stephanie H; Lionberger, Robert A

    2016-07-01

    For ophthalmic drug products, the determination of bioequivalence can be challenging, as drug concentrations at the site of action cannot always be measured. The FDA has recommended a variety of studies that can be used to demonstrate bioequivalence for different ophthalmic drug products. Product-specific bioequivalence recommendations for 28 ophthalmic products have been posted on FDA's website as of May 2016, outlining the specific tests which should be performed to demonstrate bioequivalence. The type of study that can be used to demonstrate bioequivalence depends on the drug product's active pharmaceutical ingredient(s), dosage form, indication, site of action, mechanism of action, and scientific understanding of drug release/drug availability and drug product characteristics. This article outlines the FDA's current guidance on studies to demonstrate bioequivalence through clinical endpoint studies, pharmacokinetic studies, and in vitro studies for generic ophthalmic drug products. PMID:27184578

  8. Bioequivalence of Eslicarbazepine Acetate from Two Different Sources of its Active Product Ingredient in Healthy Subjects

    OpenAIRE

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

    2013-01-01

    Purpose To compare the bioavailability (BA) and pharmacokinetic (PK) properties and to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL) in healthy volunteers. Design, subjects and methods Forty healthy male and female subjects aged 18–40 years were randomized to treatment with 400 or 800 mg ESL marketed (MF) formulation [current active pharmaceutical ingredient (API) source] and 400 or 800 mg ESL to-be-marketed (TBM) form...

  9. Bioequivalence of Two Intravenous Artesunate Products with Its Active Metabolite Following Single and Multiple Injections

    Directory of Open Access Journals (Sweden)

    Qigui Li

    2011-01-01

    Full Text Available In animal species and humans, artesunate (AS undergoes extensive and complex biotransformation to an active metabolite, dihydroartemisinin (DHA. The bioequivalence of two intravenous AS pharmaceutical products with 5% NaHCO3 (China Formulation or 0.3 M PBS (WRAIR Formulation was determined in rats in a two-formulation, two-period, and two-sequence crossover experimental design. Following single and multiple intravenous administrations, a series of blood samples was collected by using an automated blood sampler and drug concentrations were analyzed by LC-MS/MS. The 90% CI of the difference between the two intravenous formulations was contained within 80–125% of the geometric mean of pharmacokinetic parameters for AS and DHA in all animals dosed. Hematological effects were studied on days 1 and 3 after the final dosing, and a rapidly reversible hematological toxicity (significant reductions in reticulocyte levels was seen in the peripheral blood of the rats treated with each formulation. The results showed that bioequivalence with the parent compound and active metabolite was fulfilled in the 82.3–117.7% ranges of all parameters (AUC0–t, Cmax, concentration average and degree of fluctuation in the two-period and two-sequence crossover studies following single and repeated intravenous injections. For the metabolite, the equivalence was satisfied in most pharmacokinetic parameters tested due to the variability in the hydrolysis rate of AS to DHA. The WRAIR formulation of AS was considered to be bioequivalent to the Chinese formulation at steady-state according to the total drug exposure, in terms of both parent drug and active metabolite, rapidly reversal in reticulocyte decline, and extension of single and multiple administrations. Therefore, the parent drug and active metabolites should play similar important roles in the determination of efficacy and safety of the drug.

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

    Science.gov (United States)

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

    2016-07-01

    Generic agents play a crucial role in reducing the cost of medical care in many countries. However, the therapeutic equivalence remains a great concern. Our study aims to assess the in vitro antimicrobial activity and bioequivalence between generic and brand-name levofloxacin. Enantiomeric purity test, dissolution test, and in vitro antimicrobial susceptibility against seven clinically important pathogens by the agar dilution method were employed to assess the similarity between four generic products and brand-name levofloxacin (Daiichi Sankyo). All the generic and brand-name levofloxacin passed enantiomeric purity test. The results of dissolution tests were not similar among the generic products and the brand-name levofloxacin. Compared with the generic products, the brand-name levofloxacin had the smallest mean variations (-25% to 13%) with reference standard (United States Pharmacopeia levofloxacin Reference Standards). Variations were observed particularly in dissolution profiles and in vitro activity between generic products and brand-name levofloxacin. PMID:27181716

  11. International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences.

    Science.gov (United States)

    Davit, Barbara; Braddy, April C; Conner, Dale P; Yu, Lawrence X

    2013-10-01

    The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. We focused on the 13 jurisdictions and organizations participating in the International Generic Drug Regulators Pilot. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Association, Japan, Mexico, Singapore, South Korea, Switzerland, the USA, and the World Health Organization. We began with a comparison of how the various jurisdictions and organizations define a generic product and its corresponding reference product. We then compared the following bioequivalence approaches: recommended bioequivalence study designs, method of pharmacokinetic calculations and bioequivalence acceptance limits, recommendations for modifying bioequivalence study designs and limits for highly variable drugs and narrow therapeutic index drugs, provisions for waiving bioequivalence study requirements (granting biowaivers), and implementation of the Biopharmaceutics Classification System. We observed that, overall, there are more similarities than differences in bioequivalence approaches among the regulatory authorities surveyed. PMID:23821352

  12. Comparative bioequivalence study of meloxicam drugs

    OpenAIRE

    Ekut Karieva; Khаlida Yunusova

    2011-01-01

    The governments of many countries strongly support the production and clinical use of generic medicinal products which are “copies” of patented drugs and can be marked at lower cost. At present time bioequivalence testing is regarded as a useful methodology to perform comparisons among different products containing the same active ingredient. This report presents the results of comparative bioequivalence study of three meloxicam formulations: brand-drug “Melbek” with tablets and capsules of m...

  13. 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...

  14. PLATELET INHIBITORY ACTIVITY AND PHARAMCOKINETCS OF PRASUGREL A NOVEL THIENOPYRIDINE P2Y12 INHIBITOR: A SINGLE DOSE CROSS OVER BIOEQUIVALENCE STUDY IN HEALTHY HUMAN VOLUNTEERS

    Directory of Open Access Journals (Sweden)

    Sahu Nimain Charan

    2013-08-01

    Full Text Available To compare the bioavailability and bioequivalence of two prasugrel formulations one as a test and the other was the standard. The study was performed according to a randomized, open label, balanced, two-treatment, two-period, two-sequence, single-dose, crossover under fasting period with minimum of seven days wash-out period and was evaluated in 20(+ 2 stand by subjects. To analyse pharmacokinetic properties, the blood samples were drawn taken up to 36 h after dosing. Plasma concentration of prasugrel was determined using liquid chromatography – tandem mass spectrometry method. Pharmacokinetic parameters tmax, Cmax, AUC0-t, AUC0-, t1/2 and λz (Kel were tested for bioequivalence after log-transformation of data and non-parametric evaluation was done for ratios of tmax. The point estimates and 90 % confidence intervals (CI for AUC0-t, AUC0-∞, and Cmax for active metabolite (R-138727 were 95.82-105.18, 96.00-104.69 and 90.80-103.20 respectively. These results indicated that the two formulations of Prasugrel were bioequivalent in case of active metabolite (R-138727, thus may be prescribed interchangeably.

  15. [Applying multilevel models in evaluation of bioequivalence (I)].

    Science.gov (United States)

    Liu, Qiao-lan; Shen, Zhuo-zhi; Chen, Feng; Li, Xiao-song; Yang, Min

    2009-12-01

    This study aims to explore the application value of multilevel models for bioequivalence evaluation. Using a real example of 2 x 4 cross-over experimental design in evaluating bioequivalence of antihypertensive drug, this paper explores complex variance components corresponding to criteria statistics in existing methods recommended by FDA but obtained in multilevel models analysis. Results are compared with those from FDA standard Method of Moments, specifically on the feasibility and applicability of multilevel models in directly assessing the bioequivalence (ABE), the population bioequivalence (PBE) and the individual bioequivalence (IBE). When measuring ln (AUC), results from all variance components of the test and reference groups such as total variance (sigma(TT)(2) and sigma(TR)(2)), between-subject variance (sigma(BT)(2) and sigma(BR)(2)) and within-subject variance (sigma(WT)(2) and sigma(WR)(2)) estimated by simple 2-level models are very close to those that using the FDA Method of Moments. In practice, bioequivalence evaluation can be carried out directly by multilevel models, or by FDA criteria, based on variance components estimated from multilevel models. Both approaches produce consistent results. Multilevel models can be used to evaluate bioequivalence in cross-over test design. Compared to FDA methods, this one is more flexible in decomposing total variance into sub components in order to evaluate the ABE, PBE and IBE. Multilevel model provides a new way into the practice of bioequivalence evaluation.

  16. Bioavailability & Bioequivalence Studies ? Pharmaceutical Importance

    Directory of Open Access Journals (Sweden)

    Pratibha Muntha

    2015-04-01

    Full Text Available Pharmacokinetics has now emerged as an important part of drug development especially in the development of new drugs. The combined studies of Pharmacodynamics and pharmacokinetics present a thorough understanding on how the drug affects the body and how the body affects the drug.Bioavailability is the study of the rate and extent to which the active ingredient is absorbed from a dosage form and it is available at the required action site. Bioequivalence is that there should not be any significant difference in bioavailability between two products.Bioavailability (BA and bioequivalence (BE studies play a key role during the phase of drug development for both innovator drugs and generic drugs and thus have gained great attention over the past few decades. BE is used to introduce generic drugs of innovator drugs at a lower cost. So a thorough understanding of these BA/BE studies is required

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

    NARCIS (Netherlands)

    Szebeni, Janos; Storm, G

    2015-01-01

    Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequi

  18. Bioequivalence evaluation of epinephrine autoinjectors with attention to rapid delivery.

    Science.gov (United States)

    Sclar, David Alexander

    2013-01-01

    Timely and proper injection of epinephrine is critical to prevent serious consequences relating to anaphylaxis. In a recent bioavailability study comparing epinephrine delivery from the Auvi-Q™ and EpiPen(®) epinephrine autoinjectors, the Auvi-Q failed to meet the bioequivalence threshold when using partial area under the curve (AUC) analyses based on zero to Tmax recommended for highly variable drugs such as epinephrine. Peak plasma epinephrine concentrations for the EpiPen occurred 10 minutes (median Tmax) after dosing, while peak concentrations for the Auvi-Q occurred 20 minutes after dosing. Though bioequivalence may be concluded for Cmax, AUCinf, and AUC0-t, for fast-acting therapeutics used to treat life-threatening conditions, such as epinephrine, additional pharmacokinetic parameters such as AUC zero to Tmax may be important to evaluate when assessing bioequivalence.

  19. Acarbose Bioequivalence: Exploration of New Pharmacodynamic Parameters

    OpenAIRE

    Zhang, Min; Yang, Jin; Tao, Lei; Li, Lingjun; Ma, Pengcheng; Fawcett, John Paul

    2012-01-01

    To investigate bioequivalence (BE) testing of an acarbose formulation in healthy Chinese volunteers through the use of recommended and innovative pharmacodynamic (PD) parameters. Following the Food and Drug Administration (FDA) guidance, a randomized, cross-over study of acarbose test (T) and reference (R) (Glucobay®) formulations was performed with a 1-week wash-out period. Preliminary pilot studies showed that the appropriate dose of acarbose was 2 × 50 mg, and the required number of subjec...

  20. Chronicle of the Institute of Medicine physical activity recommendation: how a physical activity recommendation came to be among dietary recommendations.

    Science.gov (United States)

    Brooks, George A; Butte, Nancy F; Rand, William M; Flatt, Jean-Pierre; Caballero, Benjamin

    2004-05-01

    Under a contract from the US Department of Health and Human Services, a multidisciplinary expert panel was appointed to review "the scientific literature regarding macronutrients and energy and develop estimates of daily intake that are compatible with good nutrition throughout the life span and that may decrease the risk of chronic disease." Within the overall context of the charge, the panel sought to quantify rates and components of daily energy expenditure in healthy adults with body mass indexes (in kg/m(2)) of 18.5-25, in growing children (in the 5th-85th percentiles of weight-for-length), and in pregnant and lactating women. The recommendation for adults became the daily energy intake necessary to cover total daily energy expenditure (TEE). For special cases, dietary macronutrients and energy to support child growth and pregnancy and lactation by women were considered. TEE was based on the results of doubly labeled water studies, and the TEE results were presented in units of physical activity level (PAL = TEE/BEE) and DeltaPAL, where BEE is the basal rate of energy expenditure extrapolated to 24 h. Most adults (66%) maintaining a BMI in the healthful range had PAL values >1.6, or the equivalent of > or =60 min of physical activity of moderate intensity each day. Hence, on the basis of the doubly labeled water data and the results of epidemiologic studies, the physical activity recommendation for adults was judged to be 60 min/d. The recommendation for children was for a minimum of 60 min/d. In conclusion, dietary and physical activity recommendations for healthful living are inextricably intertwined. Adequate physical activity provides protection against chronic diseases and helps to balance energy expenditure and intake. PMID:15113740

  1. "Assessment of different bioequivalent metrics in Rifampin bioequivalence study "

    Directory of Open Access Journals (Sweden)

    "Rouini MR

    2002-08-01

    Full Text Available The use of secondary metrics has become special interest in bioequivalency studies. The applicability of partial area method, truncated AUC and Cmax/AUC has been argued by many authors. This study aims to evaluate the possible superiority of these metrics to primary metrics (i.e. AUCinf, Cmax and Tmax. The suitability of truncated AUC for assessment of absorption extent as well as Cmax/AUC and partial AUC for the evaluation of absorption rate in bioequivalency determination was investigated following administration of same product as test and reference to 7 healthy volunteers. Among the pharmacokinetic parameters obtained, Cmax/AUCinf was a better indicator or absorption rate and the AUCinf was more sensitive than truncated AUC in evaluation of absorption extent.

  2. 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 nonindiv

  3. [Bioequivalence of anvifen and phenibut].

    Science.gov (United States)

    Zhezlova, A V; Belolipetskaia, V G; Blagodatskikh, S V; Merkulova, E V

    2011-01-01

    An open randomized crossover test on 18 healthy volunteers was used to study the pharmacokinetics of anvifen (acting substance, aminophenylbutyric acid) manufactured in capsules at the Joint-Stock Company "Antiviral" (Russia). The test was performed after single peroral administration in comparison with phenibut tablets of the same manufacturer. The concentration of unchanged aminophenylbutiric acid in the blood plasma was measured by HPLC with UV detection. It is established that anvifen and phenibut are bioequivalent in terms of pharmacokinetics. PMID:21809698

  4. 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

  5. PLATELET INHIBITORY ACTIVITY AND PHARAMCOKINETCS OF PRASUGREL A NOVEL THIENOPYRIDINE P2Y12 INHIBITOR: A SINGLE DOSE CROSS OVER BIOEQUIVALENCE STUDY IN HEALTHY HUMAN VOLUNTEERS

    OpenAIRE

    Sahu Nimain Charan; P. Sri Divya; S. Ramachandran; MD. Dhana Raju

    2013-01-01

    To compare the bioavailability and bioequivalence of two prasugrel formulations one as a test and the other was the standard. The study was performed according to a randomized, open label, balanced, two-treatment, two-period, two-sequence, single-dose, crossover under fasting period with minimum of seven days wash-out period and was evaluated in 20(+ 2 stand by) subjects. To analyse pharmacokinetic properties, the blood samples were drawn taken up to 36 h after dosing. Plasma concentration of...

  6. Bioequivalence evaluation of epinephrine autoinjectors with attention to rapid delivery

    Directory of Open Access Journals (Sweden)

    Sclar DA

    2013-04-01

    Full Text Available David Alexander Sclar Department of Pharmacy Practice, College of Pharmacy, Midwestern University, Glendale, AZ, USA Abstract: Timely and proper injection of epinephrine is critical to prevent serious consequences relating to anaphylaxis. In a recent bioavailability study comparing epinephrine delivery from the Auvi-Q™ and EpiPen® epinephrine autoinjectors, the Auvi-Q failed to meet the bioequivalence threshold when using partial area under the curve (AUC analyses based on zero to Tmax recommended for highly variable drugs such as epinephrine. Peak plasma epinephrine concentrations for the EpiPen occurred 10 minutes (median Tmax after dosing, while peak concentrations for the Auvi-Q occurred 20 minutes after dosing. Though bioequivalence may be concluded for Cmax, AUCinf, and AUC0–t, for fast-acting therapeutics used to treat life-threatening conditions, such as epinephrine, additional pharmacokinetic parameters such as AUC zero to Tmax may be important to evaluate when assessing bioequivalence. Keywords: anaphylaxis, therapy, pharmacokinetics, bioavailability, EpiPen, Tmax

  7. Acarbose bioequivalence: exploration of new pharmacodynamic parameters.

    Science.gov (United States)

    Zhang, Min; Yang, Jin; Tao, Lei; Li, Lingjun; Ma, Pengcheng; Fawcett, John Paul

    2012-06-01

    To investigate bioequivalence (BE) testing of an acarbose formulation in healthy Chinese volunteers through the use of recommended and innovative pharmacodynamic (PD) parameters. Following the Food and Drug Administration (FDA) guidance, a randomized, cross-over study of acarbose test (T) and reference (R) (Glucobay®) formulations was performed with a 1-week wash-out period. Preliminary pilot studies showed that the appropriate dose of acarbose was 2 × 50 mg, and the required number of subjects was 40. Serum glucose concentrations after sucrose administration (baseline) and co-administration of sucrose/acarbose on the following day were both determined. Three newly defined PD measures of glucose fluctuation (glucose excursion (GE), GE' (glucose excursion without the effect of the homeostatic glucose control), and fAUC (degree of fluctuation of serum glucose based on AUC)), the plateau glucose concentration (C(ss)), and time of maximum reduction in glucose concentration (T (max)) were tested in the evaluation. The adequacy of the two parameters recommended by the FDA, ΔC(SG,max) (maximum reduction in serum glucose concentration) and AUEC((0-4h)) (reduction in the AUC((0-4h)) of glucose between baseline and acarbose formulation) was also evaluated. The T (max) values were comparable, and the 90% confidence intervals of the geometric test/reference ratios (T/R) for ΔC(SG,max), C(ss), GE, and fAUC were all within 80-125%. The parameter GE' was slightly outside the limits, and the parameter AUEC((0-4h)) could not be computed due to the presence of negative values. In acarbose BE evaluation, while the recommended parameter ΔC(SG,max) is valuable, the combination of C(ss) and one of the newly defined glucose fluctuation parameters, GE, GE', and fAUC is preferable than AUEC((0-4h)). The acarbose test formulation can be initially considered to be bioequivalent to Glucobay®. PMID:22419151

  8. "Pharmacodynamically evaluated bioequivalence of two preparations of Enalapril Maleate "

    Directory of Open Access Journals (Sweden)

    "Tajerzadeh H

    2001-07-01

    Full Text Available The bioequivalence of two preparations of enalapril maleate (20 mg tablets manufactured in Iran has been exploited in reference to a standard preparation (Xanef 20 tablets, MSD, Germany in 14 healthy volunteers. Following oral dosing of a single tablet of each of test and standard products, as a randomized crossover design with 10-day washout intervals, the blood samples were collected in predetermined time points and using a synthetic substrate, Hippuryl-Histidy-Leucine (HHL, the release of hippuric acid from the substrate was determined as Angiotensin-Converting-Enzyme (ACE activity of serum fractions. The percent of ACE inhibition in each sample was calculated and plotted against time, from which three pharmacodynamic parameters, i.e. Emax, tmax and AUC0-24 were derived. The results of statistical comparison of these parameters showed that both of the test preparations are bioequivalent with reference standard preparation.

  9. Developing Sidedress Nitrogen Recommendations for Corn using an Active Sensor

    Science.gov (United States)

    Active crop canopy reflectance sensors can be used during a sidedress N application to modify on-the-go fertilizer rates; but will this method be an improvement to current approaches to developing N recommendations? Our objective was to compare the potential for developing N recommendations for corn...

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

    DEFF Research Database (Denmark)

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

    2015-01-01

    and the Danish Association of Midwives were asked to complete a tested, structured questionnaire. Results: We sent 1815 invitations; the overall response rate was 54%. A majority of clinicians recommended some form of activity restriction in the nine scenarios. The midwives recommended strict or moderate...... 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....

  11. The importance of bioequivalence study: focus on clopidogrel

    Directory of Open Access Journals (Sweden)

    Arini Setiawati

    2011-05-01

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

  12. Exercise and Physical Activity Recommendations for People with Cerebral Palsy

    Science.gov (United States)

    Peterson, Mark D.; Balemans, Astrid C.J.; Hurvitz, Edward A.

    2016-01-01

    Physical activity (PA) and its promotion, as well as the avoidance of sedentary behaviour play important roles in health promotion and prevention of lifestyle-related diseases. Guidelines for typically developing youth and adults published by the World Health Organization and American College of Sports Medicine are available. However, detailed recommendations for PA and sedentary behaviour have not been established for children, adolescents and adults with cerebral palsy (CP). This paper presents the first CP-specific PA and exercise recommendations. The recommendations are based on (1) a comprehensive review and analysis of the literature, (2) expert opinion and (3) extensive clinical experience. The evidence supporting these recommendations are based on randomized controlled trials and observational studies involving children, adolescents and adults with CP, and buttressed by the previous guidelines for the general population. These recommendations may be used to guide healthcare providers on exercise and daily PA prescription for individuals with CP. PMID:26853808

  13. Predicting Nitrogen Fertilizer Recommendations for Corn using an Active Sensor

    Science.gov (United States)

    Active sensors, mounted on typical agricultural equipment, can be used to measure N (nitrogen) status in corn (Zea mays L.). This gives a producer the potential to improve N fertilizer recommendations that will reduce nitrate loss to the environment. This study examines the relationship between re...

  14. 21 CFR 320.29 - Analytical methods for an in vivo bioavailability or bioequivalence study.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Analytical methods for an in vivo bioavailability... Analytical methods for an in vivo bioavailability or bioequivalence study. (a) The analytical method used in... ingredient or therapeutic moiety, or its active metabolite(s), achieved in the body. (b) When the...

  15. Bioequivalence approach for whole effluent toxicity testing

    Energy Technology Data Exchange (ETDEWEB)

    Shukla, R.; Wang, Q.; Fulk, F.; Deng, C.; Denton, D.

    2000-01-01

    Increased use of whole effluent toxicity (WET) tests in the regulatory arena has brought increased concern over the statistical analysis of WET test data and the determination of toxicity. One concern is the issue of statistical power. A number of WET tests may pass the current hypothesis test approach because they lack statistical power to detect relevant toxic effects because of large within-test variability. Additionally, a number of WET tests may fail the current approach because they possess excessive statistical power, as a result of small within-test variability, and detect small differences that may not be biologically relevant. The strengths and limitations of both the traditional hypothesis test approach and the bioequivalence approach for use in the National Pollutant Discharge Elimination System program were evaluated. Data from 5,213 single-concentration, short-term chronic WET tests with Ceriodaphnia dubia provided the database for analysis. Comparison of results between the current approach and the bioequivalence approach indicates that the current approach to WET testing is generally sound but that adopting the proposed bioequivalence approach resolves concerns of statistical power. Specifically, within this data set, applying the bioequivalence approach resulted in failure for tests with relatively large test variability and a pass for tests with relatively small within-test variability.

  16. Comparative bioequivalence studies of tramadol hydrochloride sustained-release 200 mg tablets

    Directory of Open Access Journals (Sweden)

    Suhas S Khandave

    2010-11-01

    Full Text Available Suhas S Khandave1, Satish V Sawant1, Santosh S Joshi1, Yatish K Bansal2, Sonal S Kadam21Accutest Research Laboratories (I Private Limited, Koparkhirne, Navi Mumbai, Maharashtra, India; 2Ipca Laboratories Limited, Kandivli Mumbai, Maharashtra, IndiaBackground: Tramadol hydrochloride is available as 50 mg immediate-release (IR and 100 mg, 200 mg, and 300 mg sustained-release (SR tablets. The recommended dose of tramadol is 50–100 mg IR tablets every 4–6 hours. The tramadol SR 200 mg tablet is a better therapeutic option, with a reduced frequency of dosing, and improved patient compliance and quality of life. The present study evaluated the bioequivalence of a generic tramadol SR 200 mg tablet.Methods: A comparative in vitro dissolution study was performed on the test and reference products, followed by two separate single-dose bioequivalence studies under fasting and fed conditions and one multiple-dose bioequivalence study under fasting conditions. These bioequivalence studies were conducted in healthy human subjects using an open-label, randomized, two-treatment, two-period, two-sequence, crossover design. The oral administration of the test and reference products was done on day 1 for both the single-dose studies and on days 1–5 for the multiple-dose study in each study period as per the randomization code. Serial blood samples were collected at predefined time points in all the studies. Analysis of plasma concentrations of tramadol and O-desmethyltramadol (the M1 metabolite was done by a validated liquid chromatography-mass spectrometry analytical method. The standard acceptance criterion of bioequivalence was applied on log-transformed pharmacokinetic parameters for tramadol and its M1 metabolite.Results: The ratios for geometric least-square means and 90% confidence intervals were within the acceptance range of 80%–125% for log-transformed primary pharmacokinetic parameters for tramadol and its M1 metabolite in all the three studies

  17. Investigation of ex vivo stability of fesoterodine in human plasma and its simultaneous determination together with its active metabolite 5-HMT by LC-ESI-MS/MS: Application to a bioequivalence study.

    Science.gov (United States)

    Parekh, Jignesh M; Sanyal, Mallika; Yadav, Manish; Shrivastav, Pranav S

    2013-01-15

    Fesoterodine is a non-selective muscarinic-receptor antagonist, used in the treatment of overactive bladder syndrome. A highly sensitive, selective and rapid method has been developed for the simultaneous determination of fesoterodine and its active metabolite, 5-hydroxymethyl tolterodine (5-HMT) in human plasma by liquid chromatography-tandem mass spectrometry (LC-ESI-MS/MS). Due to rapid conversion of parent drug to 5-HMT, ex vivo stability of fesoterodine in human plasma was extensively studied to optimize the extraction protocol. The analytes and their deuterated analogs were quantitatively extracted from 100μL human plasma by liquid-liquid extraction in methyl tert-butyl ether: n-hexane. The chromatographic separation of analytes was achieved on a Kromasil C18 (100mm×4.6mm, 5μm) column under isocratic conditions. The method was validated over a dynamic concentration range of 0.01-10ng/mL for both the analytes. Ion-suppression effects were investigated by post-column infusion of analytes. The precision (% CV) values for the calculated slopes of calibration curves, which would reflect the relative matrix effect, were less than 1.5% for both the analytes. The intra-batch and inter-batch precision (% CV) across quality control levels varied from 1.82 to 3.73% and the mean extraction recovery was >96% for both the analytes. The method was successfully applied to a bioequivalence study of 8mg fesoterodine tablet formulation (test and reference) in 12 healthy Indian subjects under fasted and fed condition. The assay reproducibility estimated by reanalysis of incurred samples showed a change of ±12.0%. PMID:23266359

  18. Organizational aspects of conducting of bioequivalence study

    Directory of Open Access Journals (Sweden)

    Khokhlov A.L.

    2014-03-01

    Full Text Available Aim: to evaluate the organizational aspects of conducting bioequivalence study in Russia on the example of one of the clinical centers, Yaroslavl. Material and methods. On the basis of the Municipal Autonomous institution of health care of the Yaroslavl region Clinical hospital №2 (CH, clinical base of the Department of clinical pharmacology of YSMA was held 93 bioequivalence studies and pharmacokinetics in the period from 2011 to 2014, of which 15 studies of foreign sponsors and 78 of domestic producers. Result.: The studies involved 48 volunteers of both sexes from the database of clinical center CH №2. There were 698 females (48.6% and 739 males (51.4%. The average age of the volunteers was 26,37 years. In each study there were from 18 to 103 volunteers, depending on the design of the research Protocol. At the same time Russian studies ranged about 18-24 volunteers, about 30-103 volunteers abroad. The number of doubles in domestic studies ranged from 2 to 6 persons, and foreign — from 6 to 12 people. 10-15% from the whole number of subjects were not included into the study. Conclusion. In Russia bioequivalence of medicines for more than ten years is the main requirement of medico-biological control generic drugs. Regardless of the manufacturer to the generic drugs are exactly the same as the original drugs, must meet the following requirements: quality efficiency and safety. In connection with the increase in recent years of bioequivalence studies of medicines, require close monitoring of the quality of these studies on the territory of the Russian Federation.

  19. 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.

  20. 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.

  1. 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. PMID:24700383

  2. Active surveillance for prostate cancer: when to recommend delayed intervention

    Directory of Open Access Journals (Sweden)

    Kara N Babaian

    2015-01-01

    Full Text Available There are no agreed upon guidelines for placing patients on active surveillance (AS. Therefore, there are no absolute criteria for taking patients off AS and when to recommend treatment. The criteria used to define progression are currently based on prostate specific antigen (PSA kinetics, biopsy reclassification, and change in clinical stage. Multiple studies have evaluated predictors of progression such as PSA, PSA density (PSAD, prostate volume, core positivity, and visible lesion on multiparametric magnetic resonance imaging (mpMRI. Furthermore, published nomograms designed to predict indolent prostate cancer do not perform well when used to predict progression. Newer biomarkers have also not performed well to predict progression. These findings highlight that clinical and pathologic variables are not enough to identify patients that will progress while on AS. In the future, with the use of imaging, biomarkers, and gene expression assays, we should be better equipped to diagnose/stage prostate cancer and to distinguish between insignificant and significant disease.

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

    Science.gov (United States)

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

    2016-05-01

    The purpose was to assess the impact of the use of a chiral bioanalytical method on the conclusions of a bioequivalence study that compared two ibuprofen suspensions with different rates of absorption. A comparison of the conclusion of bioequivalence between a chiral method and an achiral approach was made. Plasma concentrations of R-ibuprofen and S-ibuprofen were determined using a chiral bioanalytical method; bioequivalence was tested for R-ibuprofen and for S-ibuprofen separately and for the sum of both enantiomers as an approach for an achiral bioanalytical method. The 90% confidence interval (90% CI) that would have been obtained with an achiral bioanalytical method (90% CI: Cmax: 117.69-134.46; AUC0 (t) : 104.75-114.45) would have precluded the conclusion of bioequivalence. This conclusion cannot be generalized to the active enantiomer (90% CI: Cmax : 103.36-118.38; AUC0 (t) : 96.52-103.12), for which bioequivalence can be concluded, and/or the distomer (90% CI: Cmax : 132.97-151.33; AUC0 (t) : 115.91-135.77) for which a larger difference was observed. Chiral bioanalytical methods should be required when 1) the enantiomers exhibit different pharmacodynamics and 2) the exposure (AUC or Cmax ) ratio of enantiomers is modified by a difference in the rate of absorption. Furthermore, the bioequivalence conclusion should be based on all enantiomers, since the distomer(s) might not be completely inert, in contrast to what is required in the current regulatory guidelines. In those cases where it is unknown if the ratio between enantiomers is modified by changing the rate of absorption, chiral bioanalytical methods should be employed unless enantiomers exhibit the same pharmacodynamics. Chirality 28:429-433, 2016. © 2016 Wiley Periodicals, Inc. PMID:27094918

  4. Bioequivalence assessment of the two brands of glimepiride tablets

    Directory of Open Access Journals (Sweden)

    Jovanović Dušan

    2006-01-01

    Full Text Available Background/Aim. Glimepiride, as an antidiabetic from the group of sulfonylurea, is administered perorally in the treatment of diabetes mellitus. The aim of this study was to compare pharmacokinetic profiles and relative bioavailabilities of the two oral formulations of glimepiride, generic and innovator tablets, after a single dose of the active drug. Methods. An oral dose of 6 mg glimepiride was given under fasting conditions to 24 healthy volunteers. A one-week washout period was applied between the two consecutive periods. The serum samples obtained before dosing, and at various time points up to 48 hours, were analyzed for glimepiride concentration using the validated highperformance liquid chromatographic method with ultraviolet detection. Pharmacokinetic parameters representing early (maximal concentration, time to reach maximal concentration and total exposure (area under the curve from the time 0 to the infinite time to glimepiride were obtained and further analyzed using the multifactorial analysis of variance and the non-parametric Wilcoxon signed ranks test. Comparison of the secondary kinetic variables was only descriptive. Results. The point estimates of the ratios of geometric means (test/reference of maximal concentrations and areas under the curve were 1.046 (90% confidence interval: 0.906−1.208 and 1.022 (90% confidence interval: 0.856−1.220, respectively, while the median values of times to reach maximal concentration, at 5% level of significance, did not differ significantly. Both formulations were well tolerated. Transient mild hypoglycaemia, which had been noted in 6 participants, resolved spontaneously within 30−60 minutes. Conclusion. Since all the parametric 90% confidence intervals for the log-transformed main variables of glimepiride were within the 0.80 and 1.25 interval, accepted as the definition of bioequivalence, and the differences in times to reach maximal concentration also did not reach statistical

  5. Pharmacokinetics and Bioequivalence Evaluation of Cyclobenzaprine Tablets

    Directory of Open Access Journals (Sweden)

    Tatiane Maria de Lima Souza Brioschi

    2013-01-01

    Full Text Available The purpose of this study was to investigate cyclobenzaprine pharmacokinetics and to evaluate bioequivalence between two different tablet formulations containing the drug. An open, randomized, crossover, single-dose, two-period, and two-sequence design was employed. Tablets were administered to 23 healthy subjects after an overnight fasting and blood samples were collected up to 240 hours after drug administration. Plasma cyclobenzaprine was quantified by means of an LC-MS/MS method. Pharmacokinetic parameters related to absorption, distribution, and elimination were calculated. Cyclobenzaprine plasma profiles for the reference and test products were similar, as well as absorption pharmacokinetic parameters AUC (reference: 199.4 ng∗h/mL; test: 201.6 ng∗h/mL, (reference: 7.0 ng/mL; test: 7.2 ng/mL, and (reference: 4.5 h; test: 4.6 h. Bioequivalence was evaluated by means of 90% confidence intervals for the ratio of AUC (93%–111% and (93%–112% values for test and reference products, which were within the 80%–125% interval proposed by FDA. Cyclobenzaprine pharmacokinetics can be described by a multicompartment open model with an average rapid elimination half-life ( of 3.1 hours and an average terminal elimination half-life ( of 31.9 hours.

  6. Design Context Aware Activity Recommender System for Iranian Customer Mind Activism in Online Shopping

    Directory of Open Access Journals (Sweden)

    Saber Pahlavan

    2013-11-01

    Full Text Available E-commerce has made life simple and innovative of individuals and groups. Nowadays, social networks are widely used by everyone. So, it is necessary to do appropriate and situation aware activities in these networks to gain benefits, In this research, a context aware recommender system has modeled for using in social networks focus on Iranian customer mind activism in online shopping. This system makes its recommendations for user based on behavior and activities of her friends in the same situation in social network. In other word, this modeled recommender system uses collaborative filtering algorithm. All the connections of user in social network, containing direct and indirect, are considered for recommending by recommender system; but, based on connection type and its distance to user, proportional factor is assigned. On the other, In this research we study the consumer behavior in online shopping of electronics especially in Iran. Primary data was collected through the questionnaire survey and by emails from personal contacts in two major cities of Iran. Price, time saving and convenience were identified as important factors which lead to certain buying behavior in online shopping.

  7. The study of bioavailability and bioequivalence of oseltamivir in Chinese health volunteers

    Institute of Scientific and Technical Information of China (English)

    LI Jing-lai; CUI Meng-cun; WANG Xiao-ying; QIAO Jian-zhong; YUAN Su-lan; ZHANG Zhen-qing; RUAN Jin-xiu; ZHONG Wu; LI Song

    2008-01-01

    Objective To evaluate the bioavailability and bioequivalence of oseltamivir capsule in Chinese health male volunteers. Methods A randomized, two period, two treatment, two sequence crossover bioequivalence trial was designed, 24 Chinese health volunteers were randomly divided into two groups, each group was orally given single dose oseltamivir phosphate (tamifla) or AMMS 607 capsule. The active metabolite oseltamivir carboxylate of oseltamivir in the plasma were determined by liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method. The pharmacokinetics parameters and relative bioavailability were calculated to evaluate the bioequivalence of AMMS 607 and tamifla. Results Cmax of the AMMS 607 and tamifla were 602.07±153.27 ng·mL-1 and 620.09±132.39 ng·mL-1 respectively; tmax were 4.2± 1.1 h and 4.8±1.0 h; t1/2β were 6.60±0.87 h and 6.61±0.83 h;MRT were 10.00±1.77 h and 10.40 ±1.62 h; AUC0-24 were 6285.88±1083.66 ng·h·mL-1 and 6546.01±1199.32 ng·h·mL-1; Compared with the reference of tamifla capsule, the bioavailability F0-tn of AMMS 607 capsule was 99.5±27.7 %. The main pharmacokinetics parameters of AUC0-24, Cmax and Tmax showed no statistically significant difference between the two capsules. Conclusions The AMMS 607 capsule and tamifla capsule are bioequivalent.

  8. The use of asymmetric distributions in average bioequivalence.

    Science.gov (United States)

    de Souza, Roberto Molina; Achcar, Jorge Alberto; Martinez, Edson Zangiacomi; Mazucheli, Josmar

    2016-07-10

    Generic drugs have been commercialized in numerous countries. Most of these countries approve the commercialization of a generic drug when there is evidence of bioequivalence between the generic drug and the reference drug. Generally, the pharmaceutical industry is responsible for the bioequivalence test under the supervision of a regulatory agency. This procedure is concluded after a statistical data analysis. Several agencies adopt a standard statistical analysis based on procedures that were previously established. In practice, we face situations in which this standard model does not fit to some sets of bioequivalence data. In this study, we propose an evaluation of bioequivalence using univariate and bivariate models based on an extended generalized gamma distribution and a skew-t distribution, under a Bayesian perspective. We introduce a study of the empirical power of hypothesis tests for univariate models, showing advantages in the use of an extended generalized gamma distribution. Three sets of bioequivalence data were analyzed under these new procedures and compared with the standard model proposed by the majority of regulatory agencies. In order to verify that the asymmetrical distributions are usually better fitted for the data, when compared with the standard model, model discrimination methods were used, such as the Deviance Information Criterion (DIC) and quantile-quantile plots. The research concluded that, in general, the use of the extended generalized gamma distribution may be more appropriate to model bioequivalence data in the original scale. Copyright © 2016 John Wiley & Sons, Ltd. PMID:26840012

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  10. 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 physical education (PE) classes 5 days a week (p 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.

  11. Increased physical activity, physician recommendation, and senior center participation

    OpenAIRE

    Swan, James H.; Keith Turner; Shilpa Shashidhara; David Sanders

    2013-01-01

    Physical activity is a recognized preventive health measure for seniors and an important focus for senior centers. This paper employs the Andersen Behavioral Model to explore increased physical activity and participation in three types of senior center activities: physical fitness, dance/aerobic classes, and chair exercises. Data were collected in 2006 on 798 and in 2007 on 742 participants at 21 multipurpose senior centers in a large urban county. Logistic regression analysis (PROC RLOG...

  12. 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.

  13. 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.

  14. International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences

    OpenAIRE

    Davit, Barbara; Braddy, April C.; Conner, Dale P.; Yu, Lawrence X.

    2013-01-01

    The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. We focused on the 13 jurisdictions and organizations participating in the International Generic Drug Regulators Pilot. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Assoc...

  15. [Physical activity in the heat: physiology of hydration recommendations].

    Science.gov (United States)

    Koulmann, N; Banzet, S; Bigard, A X

    2003-01-01

    Physical exercise in the heat causes severe disturbances in homeostasis. The need for evaporative thermolysis is increased due to the combination of endogenous and exogenous heat production. Despite a marked increase in cardiac output, muscles and skin must compete for sufficient blood flow. In addition progressive dehydration can impair the ability of the cardiocirculatory to adjust adequately. The most serious risk associated with exercise in a hot environment is heat stroke. Although deleterious effects of dehydration occur only if large amounts of water and electrolytes are lost without being replaced, even moderate fluid depletion can reduce both physical and cognitive performance. Another mechanism by which heat exposure directly affects performance involves core temperature elevation which can induce profound changes in muscular activity and energy consumption, thereby accelerating exhaustion. Prevention of deleterious effects on health and performance requires an effective rehydration strategy to maintain body fluid balance. This strategy must optimize all three potentially limiting factors for fluid replacement, i.e., fluid intake, gastric emptying, and intestinal absorption. Practical guidelines are given to answer the questions of when, what and how much to drink. PMID:15077428

  16. 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.

  17. A comparative, cross-over, double blind, randomized study for bioequivalence assessment between two formulations of valsartan capsules vs. tablets

    Directory of Open Access Journals (Sweden)

    Milena Pérez

    2006-06-01

    Full Text Available Introduction: Bioequivalence or compared equivalence studies are used to demonstrate claims that the new product, named generic product, will have the same bioavailability as the reference product, named brand product. If two products are bioequivalent it means that they would expect to have the same efficacy and security. Bioequivalence is established by the statistical estimation of significant differences or not in the pharmacokinetics parameters of area under the curve (AUC and maximum concentration (Cmax. In this case, bioequivalence will be evaluated and the bioavailability of Valsartan will be compared. Valsartan is an agent antihypertensive and specific angiotensin II antagonist acting on the AT1 receptor subtype. Objective: The aim of this study was to evaluate the bioequivalence of two pharmaceutical products whose active principle is Valsartan, based on the comparison of the pharmacokinetic measures of rate and extent (in terms of required time in which valsartan reaches the sanguineous circulation after a oral dose to 15 volunteers. Metodology: This was a randomized crossover double blind single-dose study on 15 male healthy volunteers aged between 19 and 28 years. The study was performed in two periods. Each treatment period consisted of a single-dose of 320 mg valsartan, with a wash-out time of 8 days between the first and second period. Plasma concentrations of valsartan were evaluated by HPLC/UV with method of addition of valsartan standard and losartan as internal standard. Results: Valsartan tablets formulation showed this pharmacokinetic parameters: AUC 44,893 µg/mlxh, Cmax 6,430.3 µg/ml and Tmax 2 h. Valsartan capsules formulation showed this pharmacokinetic parameters: AUC 44,963 µg/mlxh, Cmax 5,831.4 µg/ml and Tmax 2.5 h. Conclusion: The study showed no statistically significant differences in the plasma concentration levels after administration of the two formulations of valsartan: 80 mg tablets and 80 mg capsules. So

  18. A comparative, cross-over, double blind, randomized study for bioequivalence assessment between two formulations of valsartan capsules vs. tablets.

    Directory of Open Access Journals (Sweden)

    Milena Pérez

    2009-11-01

    Full Text Available Introduction: Bioequivalence or compared equivalence studies are used to demonstrate claims that the new product, named generic product, will have the same bioavailability as the reference product, named brand product. If two products are bioequivalent it means that they would expect to have the same efficacy and security. Bioequivalence is established by the statistical estimation of significant differences or not in the pharmacokinetics parameters of area under the curve (AUC and maximum concentration (Cmax. In this case, bioequivalence will be evaluated and the bioavailability of valsartan will be compared. Valsartan is an agent antihypertensive and specific angiotensin II antagonist acting on the AT1 receptor subtype. Objective: The aim of this study was to evaluate the bioequivalence of two pharmaceutical products whose active principle is Valsartan, based on the comparison of the pharmacokinetic measures of rate and extent (in terms of required time in which valsartan reaches the sanguineous circulation after a oral dose to 15 volunteers. Metodology: This was a randomized crossover double blind single-dose study on 15 male healthy volunteers aged between 19 and 28 years. The study was performed in two periods. Each treatment period consisted of a single-dose of 320 mg valsartan, with a wash-out time of 8 days between the first and second period. Plasma concentrations of valsartan were evaluated by HPLC/UV with method of addition of valsartan standard and losartan as internal standard. Results: Valsartan tablets formulation showed this pharmacokinetic parameters: AUC 44,893 µg/mlxh, Cmax 6,430.3 µg/ml and Tmax 2 h. Valsartan capsules formulation showed this pharmacokinetic parameters: AUC 44,963 µg/mlxh, Cmax 5,831.4 µg/ml and Tmax 2.5 h. Conclusion: The study showed no statistically significant differences in the plasma concentration levels after administration of the two formulations of valsartan: 80 mg tablets and 80 mg capsules. So

  19. 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.

  20. Novel montelukast sodium-loaded stable oral suspension bioequivalent to the commercial granules in rats.

    Science.gov (United States)

    Kim, Dong Wuk; Kim, Young Hun; Yousaf, Abid Mehmood; Kim, Dong Shik; Kwon, Taek Kwan; Park, Jung Hee; Kim, Yong Il; Park, Jae-Hyun; Jin, Sung Giu; Kim, Kyung Soo; Cho, Kwan Hyung; Li, Dong Xun; Kim, Jong Oh; Yong, Chul Soon; Woo, Jong Soo; Choi, Han-Gon

    2016-04-01

    To develop a montelukast sodium-loaded stable oral suspension bioequivalent to the commercial granules in rats, several montelukast sodium-loaded suspensions were prepared with a suspending agent, stabilizers and anti-aggregation agents, and their stabilities were investigated by visually observing the sedimentation phenomenon and determining the concentration of the degradation product. Moreover, dissolution and pharmacokinetic studies of the optimized formulation were examined in rats compared to commercial montelukast sodium-loaded granules. Avicel RC-591 (Avicel), a suspending agent, prevented the sedimentation of these suspensions at >2.496 (w/v) per cent composition. Amongst the stabilizers tested, fumaric acid provided the lowest concentration of montelukast sulphoxide (a degradation product) in these suspensions at 40 °C, demonstrating its excellent stabilizing activity. Furthermore, as an anti-aggregation agent, glycerin gave lower amounts of degradation product than those with poloxamer 407 and Tween 80. In particular, montelukast-loaded oral suspension, an aqueous suspension containing montelukast sodium/Avicel/fumaric acid/glycerin at a concentration of 312/2496/15.6/62.4 (mg/100 ml), and the commercial granules exhibited similar dissolution profiles in 0.5% (w/v) aqueous solution of sodium lauryl sulphate. Moreover, the pharmacokinetics in rats provided by this suspension was comparable to that of the commercial granules, suggesting that they were bioequivalent. In addition, it was physically and chemically stable at 40 °C for at least 6 months. Thus, this montelukast sodium-loaded oral suspension, with bioequivalence to the commercial granules and excellent stability, could be a prospective dosage form for the treatment of asthma.

  1. Novel montelukast sodium-loaded stable oral suspension bioequivalent to the commercial granules in rats.

    Science.gov (United States)

    Kim, Dong Wuk; Kim, Young Hun; Yousaf, Abid Mehmood; Kim, Dong Shik; Kwon, Taek Kwan; Park, Jung Hee; Kim, Yong Il; Park, Jae-Hyun; Jin, Sung Giu; Kim, Kyung Soo; Cho, Kwan Hyung; Li, Dong Xun; Kim, Jong Oh; Yong, Chul Soon; Woo, Jong Soo; Choi, Han-Gon

    2016-04-01

    To develop a montelukast sodium-loaded stable oral suspension bioequivalent to the commercial granules in rats, several montelukast sodium-loaded suspensions were prepared with a suspending agent, stabilizers and anti-aggregation agents, and their stabilities were investigated by visually observing the sedimentation phenomenon and determining the concentration of the degradation product. Moreover, dissolution and pharmacokinetic studies of the optimized formulation were examined in rats compared to commercial montelukast sodium-loaded granules. Avicel RC-591 (Avicel), a suspending agent, prevented the sedimentation of these suspensions at >2.496 (w/v) per cent composition. Amongst the stabilizers tested, fumaric acid provided the lowest concentration of montelukast sulphoxide (a degradation product) in these suspensions at 40 °C, demonstrating its excellent stabilizing activity. Furthermore, as an anti-aggregation agent, glycerin gave lower amounts of degradation product than those with poloxamer 407 and Tween 80. In particular, montelukast-loaded oral suspension, an aqueous suspension containing montelukast sodium/Avicel/fumaric acid/glycerin at a concentration of 312/2496/15.6/62.4 (mg/100 ml), and the commercial granules exhibited similar dissolution profiles in 0.5% (w/v) aqueous solution of sodium lauryl sulphate. Moreover, the pharmacokinetics in rats provided by this suspension was comparable to that of the commercial granules, suggesting that they were bioequivalent. In addition, it was physically and chemically stable at 40 °C for at least 6 months. Thus, this montelukast sodium-loaded oral suspension, with bioequivalence to the commercial granules and excellent stability, could be a prospective dosage form for the treatment of asthma. PMID:26983932

  2. Pharmacokinetics and bioequivalence of lorazepam tablets in Chinese healthy volunteers

    Institute of Scientific and Technical Information of China (English)

    Xiang-junQIU; Guo-xinHU; Jian-gangWANG; Zong-shunDAI

    2004-01-01

    AIM: To study the pharmacokinetics and bioequivalence of lorazepam tablets in Chinese healthy volunteers. METHODS:Twenty Chinese healthy male volunteers were involved in the study. Each subject received a single dose of 3 mg Lorazepam tested formulation (T, Hubei Zhongtian Airbeck Pharmaceutical Limited Company) or Lorazepam reference formulation (R, Thailand Atlatic Pharmaceutical Limited Company) with a random-

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

    Science.gov (United States)

    ... Adults Receiving a Recommendation for Exercise or Other Physical Activity From a Physician or Other Health Professional Recommend ... to begin or continue to do exercise or physical activity. Between 2000 and 2010, the percentage of adults ...

  4. Specific relationships between physical activity & mental health: the importance of considering gender & refining recommendations

    OpenAIRE

    Asztalos, Melinda

    2010-01-01

    Although there is good reason for promoting physical activity in the general public, both as preventive measure and as means of improving mental and social well-being1, physical activity promotion meant for the promotion of mental health is a rarity. Not even a simple message for the amount and type of physical activity for optimal mental health exists, and physical activity recommendations only tangentially deal with the potential of physical activity for mental health benefits. The current ...

  5. Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan.

    Science.gov (United States)

    Kuribayashi, Ryosuke; Takishita, Tomoko; Mikami, Kenichi

    2016-08-01

    Bioequivalence (BE) studies are used to infer the therapeutic equivalence of generic drug products to original drug products throughout the world. In BE studies, bioavailability (BA) should be compared between the original and generic drug products, with BA defined as the rate and extent of absorption of active pharmaceutical ingredients or active metabolites from a product into the systemic circulation. For most of BE studies conducted during generic drug development, BA comparisons are performed in single-dose studies. In Japan, the revised "Guideline for Bioequivalence Studies of Generic Products" was made available in 2012 by the Ministry of Health, Labour, and Welfare, and generic drug development is currently conducted based on this guideline. Similarly, the U.S. Food and Drug Administration and European Medicines Agency have published guidance and guideline on generic drug development. This article introduces the guideline on Japanese BE studies for oral solid dosage forms and the dissolution tests for the similarity and equivalence evaluation between the original and generic drug products. Additionally, we discuss some of the similarities and differences in guideline between Japan, the United States, and the European Union. PMID:27372551

  6. 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.

  7. From Bioequivalence to Biosimilarity: The Rise of a Novel Regulatory Framework.

    Science.gov (United States)

    Karalis, V D

    2016-01-01

    One of the most crucial issues in pharmacotherapy is to address the query if a patient can be switched from one product to another of the same active substance. For the conventional small-molecule drugs, there is a consensus on the required bioequivalence criteria. However, proving equivalence in the field of biologicals is an issue with no clear harmony. The aim of this review is to highlight the differences between the biologicals and the conventional chemical drugs, as well as, to present the different regulatory requirements for the placement of biosimilars on the market.Biologicals are substantially larger than chemical compounds, their manufacturing process is very complex, and their protein structure may trigger immune reactions. For this reason, the conventional bioequivalence approach is not adequate, but further emphasis should be placed on the quality of the manufacturing process and the risks of immunogenicity. The assessment procedure of biosimilars should encompass their comparison with the innovator product using all available evidence derived from the development process. The latter includes analytical and animal studies, pharmacokinetic and pharmacodynamic data, as well as, clinical trials focusing on immunogenicity. The US FDA has established a step-wise approach to demonstrate biosimilarity, while the EMA has already issued many guidelines referring either to all biosimilars or to specific products/classes. Overall, a case-by-case assessment procedure is considered by the regulatory authorities. In any case the placement of a biosimilar on the market does not necessarily imply interchangeability with the innovator drug. PMID:25894088

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

    OpenAIRE

    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

    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 ...

  9. 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

  10. Levothyroxine: therapeutic use and regulatory issues related to bioequivalence.

    Science.gov (United States)

    Wartofsky, Leonard

    2002-06-01

    Levothyroxine is the overwhelming choice of clinicians for the treatment of hypothyroidism and for the suppression of goitre and thyroid nodules in selected cases. The monitoring of serum levels of thyroid stimulating hormone is necessary for appropriate dosage adjustment of levothyroxine. Levothyroxine has a narrow therapeutic index: both underdosage (subclinical hypothyroidism) and excessive dosage (subclinical hyperthyroidism) are associated with adverse symptoms and pathophysiological effects and are to be avoided. The consequent necessity for careful titration of doses has had an impact on the issue of switchability, or bioequivalence, of the various marketed levothyroxine products. In this article, the basis for concern about currently accepted standards of the FDA for pharmacological bioequivalence are examined in the context of levothyroxine. The history and status of the recent request by the FDA for a new drug application for all levothyroxine products, and its impact on the market leader Synthroid, is also discussed.

  11. [What are the recommendations for sport activity following total hip or total knee arthroplasty?].

    Science.gov (United States)

    Tsur, Azmon; Volpin, Gershon

    2013-11-01

    Total hip and knee arthroplasty are surgical procedures usually performed in older adults aged 65-70 years and more, who suffer from arthritic joint degeneration, in order to relieve pain and improve functioning. In the past decade there have been more and more documentations of younger people, 50-60 years old and even less, who expect to participate in physical activity following these procedures. The trend today is to recommend activities which exert mild pressure on the implants such as swimming, cycling, golf, bowling, walking and cycling. It is not recommended to participate in sports activities that place greater pressure on the implants such as soccer, football, volleyball, handball, basketball, hockey and jogging. Such high-stress activities may cause early loosening of implants, as described in the article by Keren et al. in this issue: "Sport activity after hip and knee arthroplasty". PMID:24416821

  12. DEVELOPMENT AND BIOEQUIVALENCE STUDY OF OLANZAPINE 10mg TABLETS

    Directory of Open Access Journals (Sweden)

    Ravindra Waykar et al

    2012-09-01

    Full Text Available Generic drugs are lower-cost versions of patent-expired original brand-name medications. According to guidelines of regulatory agencies of the Canada, US and European Union, a generic drug must be “identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use”. Bioequivalence is decreed when the ratio of the generic to the reference compound for the area-under-the-curve and maximum plasma concentration (Cmax fall within a 0.80–1.25 range. The present study was to develop Olanzapine Tablets and compare pharmacokinetic profile of Zyprexa 10 mg film-coated tablets, Zyprexa Velotabs 10 mg orodispersible tablets and Olanzapine 10mg tablets. Multi media dissolution studies in 0.1N HCl, pH 4.5 acetate buffer and pH 6.8 phosphate buffer were carried out for Reference (Zyprexa Velotab 10 mg and Zyprexa 10 mg and test product (i.e. Olanzapine 10 mg. A single centre, open-label, single-dose, randomised, 3-way crossover bioequivalence study, performed under fasting conditions. Based on the results obtained, it can be concluded that the test olanzapine (Treatment A is bioequivalent to both references Zyprexa Velotab (Treatment B and Zyprexa (Treatment C following a 10 mg dose under fasting conditions. All formulations were well tolerated, with no major side effects and no relevant differences in safety profiles were observed between the preparations, particularly with respect to the number and pattern of adverse event.

  13. Transdermal fentanyl matrix patches Matrifen and Durogesic DTrans are bioequivalent

    DEFF Research Database (Denmark)

    Kress, Hans G; Boss, Hildegard; Delvin, Thomas;

    2010-01-01

    least square means of the Test/Reference ratio (90% confidence intervals [CI]) were within the range of 80-125%, demonstrating bioequivalence of Matrifen and Durogesic DTrans: AUC(0-tlast) 92.5 (CI 88.7-96.4), AUC(0-inf) 91.7 (CI 88.0-95.7), and C(max) 98.3 (CI 92.9-104.1). After 72 h application...

  14. Evaluation of bioequivalence of two oral formulations of olanzapine

    Directory of Open Access Journals (Sweden)

    R Singhal

    2011-01-01

    Full Text Available Olanzapine is an atypical antipsychotic drug, used for the management of schizophrenia and for the treatment of moderate to severe mania associated with bipolar disorder. The objective of the present randomised, crossover study was to compare the bioavailability of olanzapine 10 mg/5 ml powder for oral suspension with olanzapine 10 mg orally disintegrating tablet. Eighteen healthy male volunteers were randomly assigned to crossover, single-dose treatment regimens. Serial blood samples were collected, and plasma concentrations of olanzapine were analysed using the LC-MS/MS technique. Pharmacokinetic parameters and bioequivalence limits were calculated using non-compartmental methods. Average C max following administration of the single 10 mg disintegrating tablet formulation and 10 mg/5 ml suspension were 14.47±4.25 ng/ml and 13.56±3.99 ng/ml respectively. Corresponding median T max were 5.0 h and 6.0 h, respectively. The average AUC 0-t values and AUC 0-inf values were similar following each of the olanzapine preparations. Overall, the 90% Confidence Interval for the intra-individual ratios of the log-transformed C max and AUC values of the two formulations were within the bioequivalence interval of 80-125%. The study has demonstrated the bioequivalence of the 10 mg tablet and the 10 mg/5 ml oral suspension of olanzapine.

  15. Activity-based learner-models for Learner Monitoring and Recommendations in Moodle

    NARCIS (Netherlands)

    Florian, Beatriz; Glahn, Christian; Drachsler, Hendrik; Specht, Marcus; Fabregat, Ramón

    2011-01-01

    Florian, B., Glahn, C., Drachsler, H., Specht, M., & Fabregat, R. (2011). Activity-based learner-models for Learner Monitoring and Recommendations in Moodle. In C. D. Kloos, D. Gillet, R. M. Crespo Carcía, F. Wild, & M. Wolpers (Eds.), Towards Ubiquitous Learning: 6th European Conference on Technolo

  16. 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 str...... marketing....

  17. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations.

    NARCIS (Netherlands)

    Aletaha, D.; Landewe, R.B.; Karonitsch, T.; Bathon, J.; Boers, M.; Bombardier, C.; Bombardieri, S.; Choi, H.; Combe, B.; Dougados, M.; Emery, P.; Gomez-Reino, J.; Keystone, E.C.; Koch, G.; Kvien, T.K.; Martin-Mola, E.; Matucci-Cerinic, M.; Michaud, K.; O'Dell, J.; Paulus, H.; Pincus, T.; Richards, P.; Simon, L.; Siegel, J.; Smolen, J.S.; Sokka, T.; Strand, V.; Tugwell, P.; Heijde, D. van der; Riel, P.L.C.M. van; Vlad, S.; Vollenhoven, R. van; Ward, M.; Weinblatt, M.; Wells, G.A.; White, B.; Wolfe, F.; Zhang, B.; Zink, A.; Felson, D.T.

    2008-01-01

    OBJECTIVE: To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). METHODS: The project followed the EULAR standardised operating procedures, w

  18. 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.

  19. Prograf five milligrams versus Tacrolimus medis in healthy volunteers: a bioequivalence study.

    Science.gov (United States)

    Masri, M; Rizk, S; Boujbel, L; Bellahirich, W; Baassoumi, D; Attia, M; Matha, V

    2013-01-01

    For FDA approval, bioequivalence of a generic version of Tacrolimus must be demonstrated in a randomized, two-treatments, two-periods, two-sequences, single-dose crossover study in healthy adult volunteers. Currently there are at least 3 differents generic equivalent for Tacrolimus, that are approved by the EMA and the FDA, with a USA market share of nearly 50%. However, the market share of generic immunosuppressive drugs in the Middle East region is still very low due to the reluctance of the physician to accept Tacrolimus generics, considered to be a narrow therapeutic window drug, that are approved using the standard bioequivalence criteria of 80% to 125%. Herein we present a bioequivalence study of a new Tacrolimus generic, Tacrolimus Medis 5 mg developed by Medis Tunisia batch number 12G3003 compared with Prograf® 5 mg batch number 7202 manufactured by Astellas Toyama Co., Ltd. Japan and HIKMA Pharmaceuticals, Amman-Jordan in healthy adult volunteers using the 90%-111% criteria recommended for drugs with narrow therapeutic window. The study was, balanced, randomized, two-treatments, two-periods, two-sequences, single dose, crossover, comparative oral bioavailability study in healthy adult human volunteers. The study was carried out in accordance with the Basic Principles defined in the U.S. 21 CFR Part 312.20, the principles enunciated in the Declaration of Helsinki (World Medical Association Declaration of Helsinki). Thirty six non-smoking healthy, as determined by medical history, volunteers, 18 years and older, were included. Following randomization using a computer software (pharma solution) the volunteers were given a single oral dose of 5 milligrams following a 12 hour fast with a wash out period of 7 days. Pharmacokinetics profile with blood levels at: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours were performed following each dose. Tacrolimus plasma level was determined using an HPLC validated method (Transmedical For Life S.A.R.L. Beirut

  20. 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.

  1. Collaborative recommendations with content-based filters for cultural activities via a scalable event distribution platform

    OpenAIRE

    De Pessemier, Toon; Coppens, Sam; Geebelen, Kristof; Vleugels, Chris; Bannier, Stijn; Mannens, Erik; Vanhecke, Kris; Martens, Luc

    2012-01-01

    Nowadays, most people have limited leisure time and the offer of (cultural) activities to spend this time is enormous. Consequently, picking the most appropriate events becomes increasingly difficult for end-users. This complexity of choice reinforces the necessity of filtering systems that assist users in finding and selecting relevant events. Whereas traditional filtering tools enable e.g. the use of keyword-based or filtered searches, innovative recommender systems draw on user ratings, pr...

  2. [Trends in the quality evaluation of generic products and bioequivalence guidelines].

    Science.gov (United States)

    Yomota, Chikako

    2012-01-01

    Recent activities on the generic products such as the revision of bioequivalence guidelines, the accomplish of the reevaluation of the oral dosage forms approved before 1995, and the action program for promoting comfortable use of generics issued by MHLW in 2007, were summarized in this review. The bioequivalence guidelines established in 1997 were revised in 2012 based on the discussion in a dissolution working group (WG). The WG were consists of the members from pharmaceutical companies, academia and regulators belonging to MHLW, PMDA and NIHS. In the revision, some flexibility in the dissolution test conditions was achieved considering the many experiences. And also the special Q&A for the combination products was published at the same time. The reevaluation of the oral products since 1997 was completed in 2010, and 1361 dissolution specifications for 4133 oral products were noticed. Through the reevaluation the sufficient similarity in the dissolution profiles between the standards product and the generic products was achieved in the Japanese pharmaceutical market. In the action program to promote the share of generics, the special committee was established in the NIHS to assess the scientific papers that reported the quality concern of the commercial generic products and to confirm the target quality of the products by testing. Many generic products were checked their dissolution profile similarities to the reference products in multimedia dissolution tests and the appropriate similarities were shown in most products. In some preparations, the purity tests were performed and the content of the impurity is confirmed to be in the acceptance range. PMID:23243982

  3. 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.

  4. Bioequivalence of Progesterone Sustained Release Suppository in Rabbits

    Institute of Scientific and Technical Information of China (English)

    LONG Lihong; HUANG Qun; WU Minghui; HOU Shuxian; DAI Zongshun

    2005-01-01

    To study the bioequivalence of a kind of progesterone sustained release suppository, a randomized cross-over study was conducted in 12 rabbits. A single rectal dose of 2.75 mg/kg progesterone sustained released suppository (tested formulation, T) and progesterone suppository(reference formulation, R) was administered; a multiple dose of 2.75 mg/kg was given up to seven times with an interval of 8 h. Concentrations in serum were determined by a competitive enzyme immunoassay. The main parameters of T were: for single and multiple doses, Cmax was 48.8±11.8ng/mL and 43.5±9.4 ng/mL, Tmax was 0.5±0.3 h and 0.4±0.3 h, AUC(0-24h) was 362.4±143 ng·h·mL-1 and 310.6±70.3ng ·h·mL-1,respectively.The relative bioavailability of T to R were ( 104.2 ±13.4) % and ( 111.4 ± 19. 1 ) %, respectively. Statistical analysis showed that the two formulations were bioequivalent and T had sustained released feature.

  5. 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...... dilution bias and decreases the precision of the estimate of an association between PA and adiposity. Furthermore, because gains in adiposity often are caused by a small average daily energy imbalance over many years, following individuals for longer periods of time is essential to characterize...

  6. 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. PMID:23534844

  7. 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...

  8. Deriving bio-equivalents from in vitro bioassays: assessment of existing uncertainties and strategies to improve accuracy and reporting.

    Science.gov (United States)

    Wagner, Martin; Vermeirssen, Etiënne L M; Buchinger, Sebastian; Behr, Maximilian; Magdeburg, Axel; Oehlmann, Jörg

    2013-08-01

    Bio-equivalents (e.g., 17β-estradiol or dioxin equivalents) are commonly employed to quantify the in vitro effects of complex human or environmental samples. However, there is no generally accepted data analysis strategy for estimating and reporting bio-equivalents. Therefore, the aims of the present study are to 1) identify common mathematical models for the derivation of bio-equivalents from the literature, 2) assess the ability of those models to correctly predict bio-equivalents, and 3) propose measures to reduce uncertainty in their calculation and reporting. We compiled a database of 234 publications that report bio-equivalents. From the database, we extracted 3 data analysis strategies commonly used to estimate bio-equivalents. These models are based on linear or nonlinear interpolation, and the comparison of effect concentrations (ECX ). To assess their accuracy, we employed simulated data sets in different scenarios. The results indicate that all models lead to a considerable misestimation of bio-equivalents if certain mathematical assumptions (e.g., goodness of fit, parallelism of dose-response curves) are violated. However, nonlinear interpolation is most suitable to predict bio-equivalents from single-point estimates. Regardless of the model, subsequent linear extrapolation of bio-equivalents generates additional inaccuracy if the prerequisite of parallel dose-response curves is not met. When all these factors are taken into consideration, it becomes clear that data analysis introduces considerable uncertainty in the derived bio-equivalents. To improve accuracy and transparency of bio-equivalents, we propose a novel data analysis strategy and a checklist for reporting Minimum Information about Bio-equivalent ESTimates (MIBEST).

  9. A comparative, cross-over, double blind, randomized study for bioequivalence assessment between two formulations of valsartan capsules vs. tablets.

    OpenAIRE

    Milena Pérez; William Cárdenas; Gloria Ramírez; Mauricio Pérez; Piedad Restrepo

    2009-01-01

    Introduction: Bioequivalence or compared equivalence studies are used to demonstrate claims that the new product, named generic product, will have the same bioavailability as the reference product, named brand product. If two products are bioequivalent it means that they would expect to have the same efficacy and security. Bioequivalence is established by the statistical estimation of significant differences or not in the pharmacokinetics parameters of area under the curve (AUC) and maximum c...

  10. Evidence-based risk assessment and recommendations for physical activity: arthritis, osteoporosis, and low back pain.

    Science.gov (United States)

    Chilibeck, Philip D; Vatanparast, Hassanali; Cornish, Stephen M; Abeysekara, Saman; Charlesworth, Sarah

    2011-07-01

    We systematically reviewed the safety of physical activity (PA) for people with arthritis, osteoporosis, and low back pain. We searched PubMed, MEDLINE, Sport Discus, and the Cochrane Central Register of Controlled Trials (1966 through March 2008) for relevant articles on PA and adverse events. A total of 111 articles met our inclusion criteria. The incidence for adverse events during PA was 3.4%-11% (0.06%-2.4% serious adverse events) and included increased joint pain, fracture, and back pain for those with arthritis, osteoporosis, and low back pain, respectively. Recommendations were based on the Appraisal of Guidelines for Research and Evaluation, which applies Levels of Evidence based on type of study ranging from high-quality randomized controlled trials (Level 1) to anecdotal evidence (Level 4) and Grades from A (strong) to C (weak). Our main recommendations are that (i) arthritic patients with highly progressed forms of disease should avoid heavy load-bearing activities, but should participate in non-weight-bearing activities (Level 2, Grade A); and (ii) patients with osteoporosis should avoid trunk flexion (Level 2, Grade A) and powerful twisting of the trunk (Level 3, Grade C); (iii) patients with acute low back pain can safely do preference-based PA (i.e., PA that does not induce pain), including low back extension and flexion (Level 2, Grade B); (iv) arthritic patients with stable disease without progressive joint damage and patients with stable osteoporosis or low back pain can safely perform a variety of progressive aerobic or resistance-training PAs (Level 2, Grades A and B). Overall, the adverse event incidence from reviewed studies was low. PA can safely be done by most individuals with musculoskeletal conditions. PMID:21800948

  11. 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. PMID:25269062

  12. Sleep Quality and Recommended Levels of Physical Activity in Older People.

    Science.gov (United States)

    Hartescu, Iuliana; Morgan, Kevin; Stevinson, Clare D

    2016-04-01

    A minimum level of activity likely to improve sleep outcomes among older people has not previously been explored. In a representative UK sample aged 65+ (n = 926), cross-sectional regressions controlling for appropriate confounders showed that walking at or above the internationally recommended threshold of ≥ 150 min per week was significantly associated with a lower likelihood of reporting insomnia symptoms (OR = 0.67, 95% CI = 0.45-0.91, p walking levels at baseline significantly predicted a lower likelihood of reporting sleep onset (OR = 0.64, 95% CI = 0.42-0.97, p sleep maintenance (OR = 0.63, 95% CI = 0.41-0.95, p sleep quality in older adults. PMID:26291553

  13. Bioequivalence study of two losartan formulations administered orally in healthy male volunteers.

    Science.gov (United States)

    Bienert, Agnieszka; Brzezińiski, Rafał; Szałek, Edyta; Dubai, Vitali; Grześkowiak, Edmund; Dyderski, Stanisław; Drobnik, Leon; Wolc, Anna; Olejniczak-Rabinek, Magdalena

    2006-01-01

    The bioavailability of a new losartan preparation (2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt, CAS 114798-26-4) was compared with the reference preparation of the drug in 24 healthy male volunteers, aged between 19 and 32. The open, randomized, single-blind two-sequence, two-period crossover study design was performed. Under fasting conditions, each subject received a single oral dose of 100 mg losartan as a test or reference formulation. The plasma concentrations of losartan and its active metabolite were analyzed by a rapid and sensitive HPLC method with UV detection. The pharmacokinetic parameters included AUC0-36h, AUC0-infinity, Cmax, t1/2, and Ke. Values of AUC0-infinity demonstrate nearly identical bioavailability of losartan from the examined formulations. The AUC0-infinity of losartan was 2019.92+/-1002.90 and 2028.58+/-837.45 ng x h/ml for the test and reference formulation, respectively. The AUC0-infinity of the metabolite was 10851.52+/-4438.66 and 11041.18 +/-5015.81 ng x h/ml for test and reference formulation, respectively. The maximum plasma concentration (Cmax) of losartan was 745.94+/-419.75 ng/ml for the test and 745.74+/-329.99 ng/ml for the reference product and the Cmax of the metabolite was 1805.77+/-765.39 and 1606.22 +/-977.22 ng/ml for the test and reference product, respectively. No statistical differences were observed for Cmax and the area under the plasma concentration-time curve for both losartan and its active metabolite. 90 % confidence limits calculated for Cmax and AUC from zero to infinity (AUC0-infinity) of losartan and its metabolite were included in the bioequivalence range (0.8-1.25 for AUC). This study shows that the test formulation is bioequivalent to the reference formulation for losartan and its main active metabolite.

  14. Australian perspective regarding recommendations for physical activity and exercise rehabilitation in pulmonary arterial hypertension

    Directory of Open Access Journals (Sweden)

    Gabbay E

    2011-12-01

    Full Text Available Robin Fowler1–3, Sue Jenkins2,3,5, Andrew Maiorana2,4, Kevin Gain2,3,6,7, Gerry O'Driscoll7–9, Eli Gabbay1–3,7–91Advanced Lung Disease Program, Royal Perth Hospital, 2School of Physiotherapy and Curtin Health Innovation Research Institute, Curtin University, 3Lung Institute of Western Australia (LIWA, Centre for Asthma, Allergy and Respiratory Research, University of Western Australia, 4Advanced Heart Failure and Cardiac Transplant Service, Royal Perth Hospital, 5Physiotherapy Department, Sir Charles Gairdner Hospital, 6Respiratory Medicine Department, Royal Perth Hospital, 7School of Medicine, University of Western Australia, 8School of Medicine, University of Notre Dame, 9Heart and Lung Transplant Foundation of Western Australia, Perth, Western Australia, AustraliaAim: To determine the opinion of health care professionals within Australia, regarding acceptable levels of exertion and symptoms, and referral for exercise rehabilitation in patients with pulmonary arterial hypertension (PAH.Method: In 2010, 76 health care professionals at a specialist pulmonary hypertension meeting in Australia were surveyed using a self-administered questionnaire. The questionnaire included case studies of patients with PAH in World Health Organization (WHO functional classes II–IV. For each case study, respondents were asked to report their opinion regarding the acceptable level of exertion and symptoms during daily activities, and whether they would refer the patient for exercise rehabilitation. Three additional questions asked about advice in relation to four specific physical activities.Results: The response rate was 70% (n = 53. Overall, 58% of respondents recommended patients undertake daily activities 'as tolerated'. There was no consensus regarding acceptable levels of breathlessness or fatigue, but the majority of respondents considered patients should have no chest pain (73% and no more than mild light-headedness (92% during daily activities

  15. 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

  16. 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

  17. Bioequivalence Study of Two Orodispersible Rizatriptan Formulations of 10 mg in Healthy Volunteers

    Science.gov (United States)

    Cánovas, Mercè; Polonio, Francisco; Cabré, Francesc

    2016-01-01

    The aim of the study was to assess the bioequivalence and tolerability of two different oral formulations of rizatriptan. A bioequivalence study was carried out in 40 healthy volunteers according to an open label, randomized, two-period, two-sequence, crossover, single dose, and fasting conditions design. The test and reference formulations were administered in two treatment days, separated by a washout period of seven days. Plasma concentrations of rizatriptan were obtained by the LC/MS/MS (Liquid chromatography tandem-mass spectrometry) method. Log-transformed AUC0-t (area under the plasma concentration-time curve from zero to the last measurable concentration) and Cmax (maximum plasma concentration) values were tested for bioequivalence based on the ratios of the geometric means (test/reference). The tmax (time to reach maximum plasma concentration) was analysed nonparametrically. The 90% confidence intervals of the geometric mean values for the test/reference ratios for AUC0-t and Cmax were within the bioequivalence acceptance range of 80%–125%. According to the European Guideline, it may therefore be concluded that the test formulation of rizatriptan 10 mg orodispersible tablet is bioequivalent to the reference formulation (Maxalt® Max 10 mg oral lyophilisate). The safety profile of both formulations was consistent with the summary of the product characteristics.

  18. Presentation of the intrasubject coefficient of variation for sample size planning in bioequivalence studies.

    Science.gov (United States)

    Hauschke, D; Steinijans, W V; Diletti, E; Schall, R; Luus, H G; Elze, M; Blume, H

    1994-07-01

    Bioequivalence studies are generally performed as crossover studies and, therefore, information on the intrasubject coefficient of variation is needed for sample size planning. Unfortunately, this information is usually not presented in publications on bioequivalence studies, and only the pooled inter- and intrasubject coefficient of variation for either test or reference formulation is reported. Thus, the essential information for sample size planning of future studies is not made available to other researchers. In order to overcome such shortcomings, the presentation of results from bioequivalence studies should routinely include the intrasubject coefficient of variation. For the relevant coefficients of variation, theoretical background together with modes of calculation and presentation are given in this communication with particular emphasis on the multiplicative model.

  19. Reference tables for the intrasubject coefficient of variation in bioequivalence studies.

    Science.gov (United States)

    Steinijans, V W; Sauter, R; Hauschke, D; Diletti, E; Schall, R; Luus, H G; Elze, M; Blume, H; Hoffmann, C; Franke, G

    1995-08-01

    Bioequivalence studies are usually performed as crossover studies and, therefore, information on the intrasubject coefficient of variation is needed for sample size planning. However, this information is usually not accessible in publications on bioequivalence studies, and only the pooled inter- and intrasubject coefficient of variation for either test or reference formulation is reported. It is the purpose of the present communication to provide reference values of the intrasubject coefficient of variation for various previously investigated drugs. The presentation includes pertinent pharmacokinetic characteristics for immediate- and extended-release formulations in single- and multiple-dose crossover studies.

  20. Methods of deriving EULAR/ACR recommendations on reporting disease activity in clinical trials of patients with rheumatoid arthritis.

    NARCIS (Netherlands)

    Karonitsch, T.; Aletaha, D.; Boers, M.; Bombardieri, S.; Combe, B.; Dougados, M.; Emery, P.; Felson, D.; Gomez-Reino, J.; Keystone, E.; Kvien, T.K.; Martin-Mola, E.; Matucci-Cerinic, M.; Richards, P.; Riel, P.L.C.M. van; Siegel, J.; Smolen, J.S.; Sokka, T.; Heijde, D. van der; Vollenhoven, R. van; Ward, M.; Wells, G.; Zink, A.; Landewe, R.

    2008-01-01

    OBJECTIVE: To use an evidence-based and consensus-based approach to elaborate recommendations on how to report disease activity in clinical trials of patients with rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). MET

  1. Recommendations for Standardizing Validation Procedures Assessing Physical Activity of Older Persons by Monitoring Body Postures and Movements

    Directory of Open Access Journals (Sweden)

    Ulrich Lindemann

    2014-01-01

    Full Text Available Physical activity is an important determinant of health and well-being in older persons and contributes to their social participation and quality of life. Hence, assessment tools are needed to study this physical activity in free-living conditions. Wearable motion sensing technology is used to assess physical activity. However, there is a lack of harmonisation of validation protocols and applied statistics, which make it hard to compare available and future studies. Therefore, the aim of this paper is to formulate recommendations for assessing the validity of sensor-based activity monitoring in older persons with focus on the measurement of body postures and movements. Validation studies of body-worn devices providing parameters on body postures and movements were identified and summarized and an extensive inter-active process between authors resulted in recommendations about: information on the assessed persons, the technical system, and the analysis of relevant parameters of physical activity, based on a standardized and semi-structured protocol. The recommended protocols can be regarded as a first attempt to standardize validity studies in the area of monitoring physical activity.

  2. Testing the Recommendations of the Washington State Nutrition and Physical Activity Plan: The Moses Lake Case Study

    OpenAIRE

    Donna B. Johnson, PhD, RD; Lynne T. Smith, PhD, MPH, RD

    2006-01-01

    Background The Washington State Nutrition and Physical Activity Plan provides a framework in which policy makers can work together to build and support healthy environments for nutrition and physical activity. The city of Moses Lake, Wash, was chosen to serve as a pilot site to test the conceptual approaches and recommendations of the plan and to develop a model for healthy communities elsewhere in the state. Context Moses Lake is an ethnically diverse, geographically isolated town with a pop...

  3. Expert consensus and recommendations on safety criteria for active mobilization of mechanically ventilated critically ill adults

    OpenAIRE

    Hodgson, Carol L; Stiller, Kathy; Needham, Dale M.; Tipping, Claire J; Harrold, Megan; Baldwin, Claire E; Bradley, Scott; Berney, Sue; Caruana, Lawrence R; Elliott, Doug; Green, Margot; Haines, Kimberley; Higgins, Alisa M; Kaukonen, Kirsi-Maija; Leditschke, Isabel Anne

    2014-01-01

    Introduction The aim of this study was to develop consensus recommendations on safety parameters for mobilizing adult, mechanically ventilated, intensive care unit (ICU) patients. Methods A systematic literature review was followed by a meeting of 23 multidisciplinary ICU experts to seek consensus regarding the safe mobilization of mechanically ventilated patients. Results Safety considerations were summarized in four categories: respiratory, cardiovascular, neurological and other. Consensus ...

  4. Advice for Parents: Recommendations for Home Literacy Activities Based upon Studies of Young Successful Readers.

    Science.gov (United States)

    Rasinski, Timothy V.

    Two research studies hold promise of assisting educators in developing appropriate recommendations for helping parents help their children learn to read and write. Dolores Durkin studied children who entered school already knowing how to read. She followed the students for several years and found that the early readers maintained or extended their…

  5. Bioequivalence study of two oral tablet formulations containing tenofovir disoproxil fumarate in healthy volunteers.

    Science.gov (United States)

    Yerino, Gustavo A; Halabe, Emilia K; Zini, Elvira; Feleder, Ethel C

    2011-01-01

    Tenofovir disoproxil fumarate (TDF, CAS 147127-20-6) is a nucleotide reverse transcriptase inhibitor which is indicated in combination with other antiretroviral agents for the management of HIV-1 infection. The objective of this study was to compare the rate and extent of absorption and to assess the bioequivalence between a new pharmaceutical equivalent tablet formulation containing 300 mg of TDF and the innovator product. A randomized, single-center, open-label, single-dose, two-way crossover bioequivalence study in 40 healthy adult subjects was conducted. Dosing was separated by a wash-out period of 14 days. Blood samples were collected over 48 h and plasma levels of tenofovir (TFV) were determined by a validated HPLC assay. Rate and extent of absorption were similar between products. The 90% confidence interval (CI) of the ratio of the geometric means for log-transformed C(max), AUC(last) and AUC(inf) values were used to assess bioequivalence between the two formulations using the equivalence interval of 80 and 125%. In healthy subjects, the point estimate and 90% CI of the ratios of C(max), AUC(last) and AUC(inf) values were 0.99 (0.92-1.02), 0.99 (0.95-1.03) and 0.93 (0.85-1.02), respectively. Both treatments exhibited similar tolerability and safety. It was concluded that the new pharmaceutical product was bioequivalent to the innovator. PMID:21355446

  6. 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...

  7. Relationship Between Attainment of Recommended Physical Activity Guidelines and Academic Achievement: Undergraduate Students in Egypt

    OpenAIRE

    Ansari, Walid El; Stock, Christiane

    2014-01-01

    Introduction: 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. Methods: 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...

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

    OpenAIRE

    M. Hartmann; 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...

  9. Individual factors and school-based policies related to adherence to physical activity recommendations in Spanish adolescents.

    Science.gov (United States)

    Galán, I; Boix, R; Medrano, M J; Ramos, P; Rivera, F; Moreno, C

    2014-08-01

    Our objective was to identify individual- and school-level contextual factors related to adherence to the recommendations for physical activity in adolescents. The study used a representative sample of 15,902 students from 328 schools aged 11-18 years participating in the Spanish Health Behaviour in School-aged Children (HBSC) survey 2006. In addition to the student questionnaire, the school management board completed a questionnaire about school-based policies related to physical activity. Adherence to the recommendations was defined as "having carried out moderate and/or vigorous physical activity for at least 60 min a day on five or more days during the last week". Analysis was undertaken using multilevel logistic regression models. Individual factors associated in a statistically significant way with a higher non-compliance were: being female; being older; immigrants; tobacco smoking; being overweight or obese; low consumption of fruit and vegetables; low level of satisfaction with life; not having a high level of academic achievement; and spending a lot of time studying. The family variables were: not undertaking sports activities with the family; low socioeconomic status; and a low level of satisfaction with family relationships. Compared with schools that have a low level of policies to promote physical activities, those with a high level of promotion had an odds ratio of 0.76 (CI 95 %, 0.61-0.94). In summary, irrespective of personal and family factors, students from schools with better policies of promotion of physical activity showed a higher compliance with the recommendations. PMID:23728581

  10. Applying multilevel models in evaluation of bioequivalence(Ⅰ)%多水平模型在生物等效性评价中的应用(Ⅰ)

    Institute of Scientific and Technical Information of China (English)

    刘巧兰; 沈卓之; 陈峰; 李晓松; 杨珉

    2009-01-01

    探讨多水平模型在生物等效性评价中的应用价值.以2×4试验设计的抗高血压药生物等效性评价为研究实例,研究多水平模型对效应指标值的变异即方差的分解方式,并与FDA推荐的矩法所获得的方差分量进行比较.对比传统FDA推荐的生物等效性评价标准,研究利用多水平模型直接进行平均等效性、群体等效性和个体等效性评价的可行性.对于2×4试验设计的单变量两水平模型获得ln(AUC)指标的方差分量如试验药T的总方差σ_(TT)~2、个体间方差σ_(BT)~2和个体内方差σ_(WT)~2以及参比药R的总方差σ_(TR)~2、个体间方差σ_(BR)~2和个体内方差σ_(WR)~2,与FDA推荐的矩法所获得的结果非常接近.实际应用中,根据FDA提出的生物等效性评价的标准和程序进行评价,直接用多水平模型的估计值进行平均、群体和个体等效性评价,两者结果一致.多水平模型适合于交叉设计的生物等效性评价,相对于FDA推荐的方法,多水平模型对于复杂的有影响因素的交叉试验设计更容易估计方差分量,进而可以评价平均、群体和个体等效性,实际应用上更具有灵活性,为生物等效性评价提供了新的思路和方法.%This study aims to explore the application value of multilevel models for bioequivalence evaluation.Using a real example of 2×4 cross-over experimental design in evaluating bioequivalence of antihypertensive drug,this paper explores complex variance components corresponding to criteria statistics in existing methods recommended by FDA but obtaines in multilevel models analysis.Results are compared with those from FDA standard Method of Moments,specifically on the feasibility and applicability of multilevel models in directly assessing the bioequivalence(ABE),the population bioequivalence(PBE)and the individual bioequivalence (IBE).When measuring ln(AUC),results from all variance components of the test and reference groups such

  11. Interventions to Promote Young People's Physical Activity: Issues, Implications and Recommendations for Practice

    Science.gov (United States)

    Cale, Lorraine; Harris, Jo

    2006-01-01

    There has been increased interest in the development and implementation of physical activity interventions designed to increase young people's physical activity participation in recent years. This is perhaps founded on concerns over youngsters' physical activity levels and the possible health consequences. School-based interventions are the most…

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

    Science.gov (United States)

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

    2012-01-01

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

  13. Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report.

    Science.gov (United States)

    Adams, Wallace P; Ahrens, Richard C; Chen, Mei-Ling; Christopher, David; Chowdhury, Badrul A; Conner, Dale P; Dalby, Richard; Fitzgerald, Kevin; Hendeles, Leslie; Hickey, Anthony J; Hochhaus, Günther; Laube, Beth L; Lucas, Paul; Lee, Sau L; Lyapustina, Svetlana; Li, Bing; O'Connor, Dennis; Parikh, Neil; Parkins, David A; Peri, Prasad; Pitcairn, Gary R; Riebe, Michael; Roy, Partha; Shah, Tushar; Singh, Gur Jai Pal; Sharp, Sandra Suarez; Suman, Julie D; Weda, Marjolein; Woodcock, Janet; Yu, Lawrence

    2010-02-01

    This March 2009 Workshop Summary Report was sponsored by Product Quality Research Institute (PQRI) based on a proposal by the Inhalation and Nasal Technology Focus Group (INTFG) of the American Association of Pharmaceutical Scientists (AAPS). Participants from the pharmaceutical industry, academia and regulatory bodies from the United States, Europe, India, and Brazil attended the workshop with the objective of presenting, reviewing, and discussing recommendations for demonstrating bioequivalence (BE) that may be considered in the development of orally inhaled drug products and regulatory guidances for new drug applications (NDAs), abbreviated NDAs (ANDAs), and postapproval changes. The workshop addressed areas related to in vitro approaches to demonstrating BE, biomarker strategies, imaging techniques, in vivo approaches to establishing local delivery equivalence and device design similarity. The workshop presented material that provided a baseline for the current understanding of orally inhaled drug products (OIPs) and identified gaps in knowledge and consensus that, if answered, might allow the design of a robust, streamlined method for the BE assessment of locally acting inhalation drugs. These included the following: (1) cascade impactor (CI) studies are not a good 2 predictor of the pulmonary dose; more detailed studies on in vitro/in vivo correlations (e.g., suitability of CI studies for assessing differences in the regional deposition) are needed; (2) there is a lack of consensus on the appropriate statistical methods for assessing in vitro results; (3) fully validated and standardized imaging methods, while capable of providing information on pulmonary dose and regional deposition, might not be applicable to the BE of inhaled products mainly due to the problems of having access to radiolabeled innovator product; (4) if alternatives to current methods for establishing local delivery BE of OIPs cannot be established, biomarkers (pharmacodynamic or clinical

  14. Distributed smart home activity recommender system using hidden Markov model principles

    DEFF Research Database (Denmark)

    Lynggaard, Per

    2013-01-01

    A smart home is able to propose learned activities to its user and learn new activities by observing the user’s behavioral patterns, that is, the user’s actions. Most of today’s discussed systems use some more or less complex classifier algorithms to predict user activities from contextual...... available data set that offers approximately seven months of annotated activity including 6468 sensor events produced by a women living in the test home. Using this data set, it has been shown that this system can achieve good performance with a recognition probability of 75%....

  15. School-Based Physical Activity Interventions: Effectiveness, Trends, Issues, Implications and Recommendations for Practice

    Science.gov (United States)

    Cale, Lorraine; Harris, Jo

    2006-01-01

    The promotion of physical activity within schools and physical education (PE) has attracted growing interest in recent years. Schools have been acknowledged as the primary institution with responsibility for promoting activity in young people and more specifically, school PE has been recognized as having a key role to play. Given this, and based…

  16. Evidence-based risk assessment and recommendations for physical activity clearance: respiratory disease.

    Science.gov (United States)

    Eves, Neil D; Davidson, Warren J

    2011-07-01

    The 2 most common respiratory diseases are chronic obstructive pulmonary disease (COPD) and asthma. Growing evidence supports the benefits of exercise for all patients with these diseases. Due to the etiology of COPD and the pathophysiology of asthma, there may be some additional risks of exercise for these patients, and hence accurate risk assessment and clearance is needed before patients start exercising. The purpose of this review was to evaluate the available literature regarding the risks of exercise for patients with respiratory disease and provide evidence-based recommendations to guide the screening process. A systematic review of 4 databases was performed. The literature was searched to identify adverse events specific to exercise. For COPD, 102 randomized controlled trials that involved an exercise intervention were included (n = 6938). No study directly assessed the risk of exercise, and only 15 commented on exercise-related adverse events. For asthma, 30 studies of mixed methodologies were included (n = 1278). One study directly assessed the risk of exercise, and 15 commented on exercise-related adverse events. No exercise-related fatalities were reported. The majority of adverse events in COPD patients were musculoskeletal or cardiovascular in nature. In asthma patients, exercise-induced bronchoconstriction and (or) asthma symptoms were the primary adverse events. There is no direct evidence regarding the risk of exercise for patients with COPD or asthma. However, based on the available literature, it would appear that with adequate screening and optimal medical therapy, the risk of exercise for these respiratory patients is low. PMID:21800949

  17. Testing the Recommendations of the Washington State Nutrition and Physical Activity Plan: The Moses Lake Case Study

    Directory of Open Access Journals (Sweden)

    Donna B. Johnson, PhD, RD

    2006-03-01

    Full Text Available Background The Washington State Nutrition and Physical Activity Plan provides a framework in which policy makers can work together to build and support healthy environments for nutrition and physical activity. The city of Moses Lake, Wash, was chosen to serve as a pilot site to test the conceptual approaches and recommendations of the plan and to develop a model for healthy communities elsewhere in the state. Context Moses Lake is an ethnically diverse, geographically isolated town with a population of about 15,000. Methods An advisory committee used data from an inventory of local policies and environments, along with the recommendations from the state plan, to develop a plan for Healthy Communities Moses Lake. Three initiatives were chosen for the first actions: a connected system of trails and paths, enhanced facilities for breastfeeding in the community, and a community garden. Consequences Records of cumulative actions demonstrated that Healthy Communities Moses Lake continued to be an active and productive project. Initial measures of success were collected by each of the three first action teams. Environmental changes will be monitored by comparison with the initial inventory of local policies. Long-term health outcomes in Moses Lake will be monitored by the Washington State Department of Health.

  18. Improving in-season nitrogen recommendations for maize using an active sensor

    Science.gov (United States)

    An active crop canopy reflectance sensor could be used to increase N-use efficiency in corn (Zea mays L.), if temporal and spatial variability in soil N availability and plant demand are adequately accounted for with an in-season N application. Our objective was to evaluate the success of using an a...

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

    DEFF Research Database (Denmark)

    Mattsson, Jan; Söderlund, Magnus

    2015-01-01

    This paper examines if a mere request to a customer – within the frame of a service encounter – to engage in word-of-mouth (WOM) would have an impact on the customer's subsequent WOM activity. Although previous studies have not examined this issue, theoretical arguments do exist. And they point...

  20. Choice-Making in Vocational Activities Planning: Recommendations from Job Coaches

    Science.gov (United States)

    Cobigo, Virginie; Lachapelle, Yves; Morin, Diane

    2010-01-01

    Choice in the job seeking process may lead to increased satisfaction with the chosen job, and improve attention, performance, and motivation. Consequently, providing opportunities to express choices and interests while planning vocational activities is a key factor in achieving employment outcomes. Despite their commitment to promoting…

  1. Primary caregiver knowledge of paediatric physical activity recommendations in the United Kingdom and its association with caregiver behaviour: an observational study

    OpenAIRE

    Sawyer, A; Smith, L; Schrempft, S; van Jaarsveld, C.H.; Wardle, J.; Fisher, A.

    2014-01-01

    Background Most children in affluent developed countries do not meet basic physical activity recommendations. This study assessed primary caregiver knowledge of the UK recommendations on physical activity for children and examined the relationship between knowledge and components of parental support and modelling of physical activity. Methods Data were from a large, community-based twin birth cohort. Primary caregivers were invited to take part in a telephone interview on the home food and ac...

  2. New recommended schedule for active immunization of normal infants and children.

    Science.gov (United States)

    1986-09-19

    A large, randomized, double-blind trial has made available sufficient data to recommend the simultaneous administration of combined measles-mumps-rubella (MMR), diphtheria and tetanus toxoids and pertussis (DTP), and oral poliovirus (OPV) vaccines to all children 15 months old or older who are eligible to receive these vaccines. In this trial, serologic response and clinical reaction rates following primary immunization with MMR were compared in a test group of 405 children given MMR simultaneously with DTP and OPV and a control group of 410 children given MMR followed by doses of DTP and OPV vaccine 2 months later. Seroconversion rates to each MMR component exceeded 96% in both groups, and the geometric mean titers achieved against the other 6 antigens also were similar in both groups. Rates of most of the common vaccine-associated clinical reactions to DTP and MMR were not augmented by simultaneous administration of these 2 vaccines. Some minor side effects were reported more frequently in the simultaneous-administration group, but these difference were judged to be related to artifacts of the study design rather than to differences in the safety of the 2 vaccine schedules. Data from the Center for Disease Control's Monitoring System for Adverse Events Following Immunization have been reviewed, particularly the information from Idaho, Louisiana, and Tennessee, where policies to administer MMR, DTP, and OPV simultaneously have been in effect for periods ranging from several months to years. The evidence suggests no increased risk of reactions associated with the simulaneous administration of these antigens. The overall implications of simultaneous administartion have not been fully defined, but it is anticipated that implementation of this new schedule will result in at least 3 benefits: a decrease in the number of health care provider visits required for immunization during the 2nd year of life, and accompanying decrease in costs, and an increase in the

  3. Application of Absorption Modeling to Predict Bioequivalence Outcome of Two Batches of Etoricoxib Tablets

    OpenAIRE

    Mitra, Amitava; Kesisoglou, Filippos; Dogterom, Peter

    2014-01-01

    As part of the overall product development and manufacturing strategy, pharmaceutical companies routinely change formulation and manufacturing site. Depending on the type and level of change and the BCS class of the molecule, dissolution data and/or bioequivalence (BE) may be needed to support the change for immediate release dosage forms. In this report, we demonstrate that for certain weakly basic low-solubility molecules which rapidly dissolve in the stomach, absorption modeling could be u...

  4. Bioequivalence study of two oral formulations of clarithromycin in human male subjects.

    Science.gov (United States)

    Khan, M Khalid; Khan, M F; Mustafa, G; Sualah, M

    2011-01-01

    To assess the bioequivalence of tablets formulations of Clarithromycin 500 mg each of test and reference products. A single post oral dose of each formulation was given to 14 male healthy volunteers. The study was conducted phase 1, open-label, randomized, complete two-way crossover designed with 7 days wash out period. The plasma concentration of Clarithromycin was quantified by validated microbiological assay method. The precision of the method was evaluated using calibrated 14-hydroxyClarithromycin concentration was detected semi quantitatively as equivalent of Clarithromycin/ml. The peak plasma concentrations of (3.63±0.80 ug/ml) and (3.31±0.35 ug/ml) was attained in about 1.42 hours and 1.49 hours for both test and reference Clarithromycin tablets respectively. The mean±SD values for total area under the curve (AUC) were 22.07±4.90 and 20.16±2.35 h.mg/L for both test and reference tablets respectively. This study indicated that the differences in all the bioequivalence parameters for test and reference Clarithromycin formulations are statistically non-significant; hence both formulations are considered bioequivalent. PMID:21190917

  5. Tests for bioequivalence of control media and test media in studies of toxicity

    Energy Technology Data Exchange (ETDEWEB)

    Erickson, W.P.; McDonald, L.L. [Western EcoSystems Technology, Inc., Cheyenne, WY (United States)

    1995-07-01

    Statistical tests of the classical (null) hypothesis--that there is no difference in effects of control media and tested--are commonly used to make statistical inferences toward the no-observed-adverse-effect concentration. However, failing to rejects this hypothesis is not considered as scientific proof the hypothesis is true. An effect may exist, but high variation due to inadequate replication, variation in experimental units, or imprecise measurement techniques may yield data for which the hypothesis is not rejected. An experiment may also be too precise, yielding effects that are statistically significant but not biologically important. The authors propose the use of tests of bioequivalence of control media and test media to alleviate these unsatisfactory characteristics of tests and of the classical hypotheses for regulatory decisions. They review and illustrate the test for bioequivalence using acute and chronic toxicity data. They also define a procedure for determining the level of effect at which there will be high power to refute the hypothesis that there is a lack of bioequivalence if in fact the biological response in the control media is identical to the responses in the test media.

  6. Food preference and foraging activity of ants: recommendations for field applications of low-toxicity baits.

    Science.gov (United States)

    Nyamukondiwa, Casper; Addison, Pia

    2014-01-01

    Control of ants using baits of low toxicity cannot be effective without knowledge of bait distribution patterns and bait station densities, which are determined by ants' foraging activities. Furthermore, the success of toxic baits also depends upon attractiveness of bait carriers. Here, we assessed ground and vine foraging activity and food preferences for the three ant species ( Linepithema humile (Mayr) (Hymenoptera: Formicidae), Anoplolepis custodiens (F. Smith) and Crematogaster peringueyi Emery) under field conditions. We found that L. humile's vineyard foraging activity was high and that movement of ant bait by C. peringueyi and A. custodiens in the vineyard was relatively low. Consequently, more bait stations need to be dispensed for more effective control of C. peringueyi and A. custodiens than for L. humile. Different bait densities are discussed for the various ant species. Food preference trials indicated that vineyard foraging ants preferred wet bait attractants over dry ones, making liquids the most ideal carriers for baiting these ants. Linepithema humile was attracted to 25% sugar water, while C. peringueyi was attracted to both 25% sugar water and honey. Anoplolepis custodiens was attracted to tuna but was also attracted to 25% sugar water. Thus, future bait formulations should be tailor made to suit these specific food requirements if baits are to be successful in ant pest management. PMID:25373195

  7. Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products of agomelatine in Chinese subjects

    Directory of Open Access Journals (Sweden)

    Fang Tang

    2016-01-01

    Full Text Available The aim of this study was to apply the reference-scaled average bioequivalence (RSABE approach to evaluate the bioequivalence of 2 formulations of agomelatine, and to investigate the pharmacokinetic properties of agomelatine in Chinese healthy male subjects. This was performed in a single-dose, randomized-sequence, open-label, four-way crossover study with a one-day washout period between doses. Healthy Chinese males were randomly assigned to receive 25 mg of either the test or reference formulation. The formulations were considered bioequivalent if 90% confidence intervals (CIs for the log-transformed ratios and ratio of geometric means (GMR of AUC and Cmax of agomelatine were within the predetermined bioequivalence range based on RSABE method. Results showed that both of the 90% CIs for the log-transformed ratios of AUC and Cmax of 7-desmethyl-agomelatine and 3-hydroxy-agomelatine were within the predetermined bioequivalence range. The 90% CIs for natural log-transformed ratios of Cmax, AUC0–t and AUC0–∞ of agomelatine (104.42–139.86, 101.33–123.83 and 97.90–117.94 were within the RSABE acceptance limits, and 3-hydroxy-agomelatine (105.55–123.03, 101.95–109.10 and 101.72–108.70 and 7-desmethyl-agomelatine (104.50–125.23, 102.36–111.50 and 101.62–110.64 were within the FDA bioequivalence definition intervals (0.80–1.25 for AUC and 0.75–1.33 for Cmax. The RSABE approach was successful in evaluating the bioequivalence of these two formulations.

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

    Science.gov (United States)

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

    2016-06-01

    In this critical narrative review, we examine the role of physical activity (PA), recreational and elite sports in the development of knee/hip osteoarthritis (OA), taking into account the role of injury in this relationship. The process of article selection was unsystematic. Articles were selected on the basis of the authors' expertise, self-knowledge, and reflective practice. In the general adult population, self-reported diagnosis of knee/hip OA was not associated with low, moderate or high levels of PA. For studies using radiographic knee/hip OA as a primary outcome, the incidence of asymptomatic radiographic OA was higher for subjects with the highest quartile of usual PA than the least active subjects. The risk of incident radiographic knee/hip OA features was increased for subjects with a history of regular sports participation (for osteophyte formation but not joint space narrowing). This risk depended on the type of sport (team and power sports but not endurance and running), and certain conditions (high level of practice) were closely related to the risk of injury. The prevalence of radiographic OA was significantly higher, especially the presence of osteophytes, in former elite athletes than controls. The risk of OA was higher with participation in mixed sports, especially soccer or power sports, than endurance sport. However, the prevalence of clinical OA between former elite athletes and controls was similar, with less hip/knee disability in former athletes. Moderate daily recreational or sport activities, whatever the type of sport, are not a consistent risk factor for clinical or radiographic knee/hip OA. Risk of injury in different sports may be the key factor to understanding the risk of OA related to sport. PMID:27103057

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

    Directory of Open Access Journals (Sweden)

    Graeme Shannon

    2014-08-01

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

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

    Science.gov (United States)

    Gallaway, Patrick J.; Hongu, Nobuko

    2016-01-01

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

  11. Bioequivalence study of two formulations of candesartan cilexetil tablet in healthy subjects under fasting conditions

    Directory of Open Access Journals (Sweden)

    Tjandrawinata RR

    2013-08-01

    Full Text Available Raymond R Tjandrawinata,1 Effi Setiawati,2 Danang Agung Yunaidi,2 Ronal Simanjuntak,2 Iwan Dwi Santoso,2 Liana W Susanto1 1Dexa Laboratories of Biomolecular Sciences (DLBS, Cikarang, Indonesia; 2Bioavailability and Bioequivalence Laboratory, PT Equilab International, Jakarta, Indonesia Introduction: The present study was conducted to compare the bioavailability of two candesartan cilexetil 16 mg tablet formulations (test and reference formulations. Materials and methods: This study was a randomized, single- blind, two-period, cross-over study which included 24 healthy adult male and female subjects under fasting conditions. The pharmacokinetic parameters were determined based on the concentrations of candesartan (CAS 139481-59-7, using ultra-pressure high-performance liquid chromatography with a tandem mass spectrometer detector. In each of the two study periods (separated by a washout period of 1 week, a single dose of test or reference product was administered. The pharmacokinetic parameters assessed were area under the plasma concentration time curve (AUC from time 0 hours to 24 hours, AUC from time zero to infinity, the peak plasma concentration of the drug (Cmax, time to achieve the Cmax, and the elimination half-life. Results: The geometric mean ratios (90% confidence interval of the test drug/reference drug for candesartan were 100.92% (92.15%–110.52% for the AUC from 0 hours to 24 hours, 100.24% (92.24%–108.95% for the AUC from time zero to infinity, and 106.71% (93.20%–122.18% for the Cmax. The differences between the test and reference product in the time to achieve Cmax values and elimination half-life values were not statistically significant (P > 0.05. The 90% confidence intervals of the test/reference AUC ratio and Cmax ratio of candesartan were within the acceptance range for bioequivalence. There was no adverse event encountered during this bioequivalence study. Conclusion: It was concluded that the two candesartan tablet

  12. Bioequivalence study of two formulations of bisoprolol fumarate film-coated tablets in healthy subjects

    Directory of Open Access Journals (Sweden)

    Tjandrawinata RR

    2012-10-01

    Full Text Available Raymond R Tjandrawinata,1 Effi Setiawati,2 Danang Agung Yunaidi,2 Iwan Dwi Santoso,2 Arini Setiawati,3 Liana W Susanto11Dexa Laboratories of Biomolecular Sciences (DLBS, Cikarang, Indonesia; 2Bioavailability and Bioequivalence Laboratory, Equilab International, Jakarta, Indonesia; 3Department of Pharmacology and Therapeutics, University of Indonesia, Jakarta, IndonesiaBackground: The present study was conducted to compare the bioavailability of two bisoprolol fumarate 5 mg film-coated tablet formulations (test and reference formulations.Patients and methods: This study was a randomized, single-blind, two-period, two-sequence crossover study that included 18 healthy adult male and female subjects under fasting condition. The pharmacokinetic parameters were determined based on the concentrations of bisoprolol (CAS 66722-44-9, using ultraperformance liquid chromatography with a tandem mass spectrometer detector. In each of the two study periods (separated by a washout of 1 week a single dose of test or reference product was administered. The pharmacokinetic parameters assessed were area under the plasma concentration-time curve from time zero to 48 hours (AUCt, AUC from time zero to infinity (AUCinf, the peak plasma concentration of the drug (Cmax, time needed to achieve Cmax (tmax, and the elimination half-life (t½.Results: The geometric mean ratios (90% confidence intervals of the test drug/reference drug for bisoprolol were 101.61% (96.14%–107.38% for AUCt, 101.31% (95.66%–107.29% for AUCinf, and 100.28% (93.90%–107.09% for Cmax. The differences between the test and reference drug products for bisoprolol tmax and t½ values were not statistically significant (P > 0.05. There was no adverse event encountered during this bioequivalence test. The 90% confidence intervals of the test/reference AUC ratio and Cmax ratio of bisoprolol were within the acceptance range for bioequivalence.Conclusion: It was concluded that the two bisoprolol film

  13. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2012-06-08

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

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

    Directory of Open Access Journals (Sweden)

    J.R. Poortmans

    2012-10-01

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

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

    International Nuclear Information System (INIS)

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

  17. An open-label,randomized,cross-over bioequivalence study of lafutidine 10 mg under fasting condition

    Institute of Scientific and Technical Information of China (English)

    Bhupesh; Dewan; Raghuram; Chimata

    2010-01-01

    AIM:To assess the relative bioavailability and pharmacokinetic properties of two formulations(test and reference) of Lafutidine 10 mg.METHODS:The study was performed as an open label,randomized,two-way,two-period,two-treatment,single dose cross-over bioequivalence study,under non-fed condition to compare the pharmacokinetic prof iles of the lafutidine formulation manufactured by Emcure Pharmaceuticals Ltd.,India using an indigenously developed active pharmaceutical ingredient(API) and the commercially available Stogra formulation,of UCB Japan Co.,Ltd.,Japan.The two treatments were separated by a washout period of 5 d.After an overnight fasting period of 10 h,the subjects were administered either the test or the reference medication as per the randomization schedule.Blood samples were collected at intervals up to 24 h,as per the approved protocol.Concentrations of lafutidine in plasma were analyzed by a validated liquid chromatography/tandem mass spectrometry(LC/MS/MS) method,and a non-compartmental model was used for pharmacokinetic analysis.The pharmacokinetic parameters were subjected to a 4-way ANOVA accounting for sequence,subjects,period and treatment.Statistical significance was evaluated at 95% conf idence level(P ≥ 0.05).RESULTS:The mean(±SD) values of the pharmacokinetic parameters(test vs reference) were Cmax(265.15±49.84 ng/mL vs 246.79±29.30 ng/mL,P<0.05),Area under the curve(AUC)(0-t)(1033.13±298.74 ng.h/mL vs 952.93±244.07 ng.h/mL,P < 0.05),AUC(0-∞)(1047.61±301.22 ng.h/mL vs 964.21±246.45 ng.h/mL,P<0.05),and tv2(1.92±0.94 h vs 2.05±1.01 h,P<0.05).The 90% conf idence intervals(CI) for the test/reference ratio of mean Cmax,AUC(0-t),and AUC(0-∞) were within the acceptable range of 80.00 to 125.00.The mean times(± SD) to attain maximal plasma concentration(tmax) of lafutidine were 0.95±0.24 h vs 1.01±0.29 h(P<0.05) for the test and the reference formulations respectively.Both the formulations were well tolerated.

  18. BRIDGING THE GAP OF INDIAN REGULATIONS AND MAJOR GLOBAL REGULATIONS FOR BIOEQUIVALENCE STUDIES WITH EMPHASIS ON ADAPTIVE SEQUENTIAL DESIGN AND TWO-STAGE BIOEQUIVALENCE STUDIES

    Directory of Open Access Journals (Sweden)

    Shah Kalpesh

    2013-04-01

    Full Text Available The cost of healthcare has been escalating globally during the last two decades, and this has prompted efforts in most countries to reduce those costs. Because of the importance of generic drugs in healthcare, it is imperative that the pharmaceutical quality and in vivo performance of generic drugs be reliably assessed. Because generic drugs would be interchanged with innovator products in the market place, it must be demonstrated that the safety and efficacy of generics are comparable to the safety and efficacy of the corresponding innovator drugs. The concept of bioavailability (BA and bioequivalence (BE has been accepted worldwide by the pharmaceutical industry and national regulatory authorities for over 20 years and is applied to new as well as generic products. As a result, thousands of high-quality generic drugs at reduced costs have become available in every corner of the globe. The assessment of BE is not a simple issue, however, and much of the research has been done in recent years to develop new and more effective approaches to the assessment of BE. There are several approaches to assess BE and each regulatory authority has its own regulations/guidance for conducting BA/BE studies before approving generic products for marketing in their country. Therefore, a thorough understanding is required of these BA/BE concepts and basic regulatory requirements for conduct of BA/BE studies. In this article, the regulatory guidelines are compared on the basis of various parameters involving the clinical conduct of the BA/BE studies. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Another upcoming approach for conduct of bioequivalence studies is Adaptive design, which is a relatively new approach. This innovation is becoming accepted by the regulators and has been taken up by the pharmaceutical industry to reduce product development times and costs. There

  19. Does practicing hatha yoga satisfy recommendations for intensity of physical activity which improves and maintains health and cardiovascular fitness?

    Directory of Open Access Journals (Sweden)

    Rundle Andrew

    2007-11-01

    Full Text Available Abstract Background Little is known about the metabolic and heart rate responses to a typical hatha yoga session. The purposes of this study were 1 to determine whether a typical yoga practice using various postures meets the current recommendations for levels of physical activity required to improve and maintain health and cardiovascular fitness; 2 to determine the reliability of metabolic costs of yoga across sessions; 3 to compare the metabolic costs of yoga practice to those of treadmill walking. Methods In this observational study, 20 intermediate-to-advanced level yoga practitioners, age 31.4 ± 8.3 years, performed an exercise routine inside a human respiratory chamber (indirect calorimeter while wearing heart rate monitors. The exercise routine consisted of 30 minutes of sitting, 56 minutes of beginner-level hatha yoga administered by video, and 10 minutes of treadmill walking at 3.2 and 4.8 kph each. Measures were mean oxygen consumption (VO2, heart rate (HR, percentage predicted maximal heart rate (%MHR, metabolic equivalents (METs, and energy expenditure (kcal. Seven subjects repeated the protocol so that measurement reliability could be established. Results Mean values across the entire yoga session for VO2, HR, %MHR, METs, and energy/min were 0.6 L/kg/min; 93.2 beats/min; 49.4%; 2.5; and 3.2 kcal/min; respectively. Results of the ICCs (2,1 for mean values across the entire yoga session for kcal, METs, and %MHR were 0.979 and 0.973, and 0.865, respectively. Conclusion Metabolic costs of yoga averaged across the entire session represent low levels of physical activity, are similar to walking on a treadmill at 3.2 kph, and do not meet recommendations for levels of physical activity for improving or maintaining health or cardiovascular fitness. Yoga practice incorporating sun salutation postures exceeding the minimum bout of 10 minutes may contribute some portion of sufficiently intense physical activity to improve cardio

  20. Recommended Paperbacks.

    Science.gov (United States)

    Horn Book Magazine, 1980

    1980-01-01

    Lists recommended paperback books for children in the following categories: picture books; stories for younger, for intermediate, and for older readers; folklore, legend, and mythology; and nonfiction. Tells if and when the original editions were reviewed in this journal. (GT)

  1. Recommended Wilderness

    Data.gov (United States)

    National Park Service, Department of the Interior — Recommended wilderness is an Arcview shapefile representing the porposed wilderness areas throughout the park. The boundaries for this data set were digitized by...

  2. Somatic characteristics in relation to meeting recommended physical activity in overweight and obese women aged 30-60 years

    Directory of Open Access Journals (Sweden)

    Tereza Sofková

    2015-09-01

    Full Text Available Background: Physical activity (PA can provide health benefits and thus reduce the risk of complications from obesity and improve mental well-being. We consider body composition as an acceptable indicator of the functional condition of the body. Aims: Our research objective was to analyse selected body composition fractions in relation to meeting recommended PA in overweight and obese women. Methods: 221 women participated in our study, divided in two age groups: 30 to 44.9 years (Maturus I, n = 118 and 45 to 60 years (Maturus II, n = 103. Each age group was further differentiated by sub-groups (adequate and inadequate PA according to the achieved PA level (medium PA: 3 to 6 MET; ≥ 150 min/week. To determine the PA parameters within one week the ActiGraph GT1M accelerometer was used. The InBody 720 body composition analyser was used to determine body composition parameters. Descriptive characteristics and data analysis were carried out using Statistica 10.0. Differences were compared by the Student's t-test. Statistical significance level was set at α < .05. Results: Younger women who achieved adequate PA reached lower average values of body fat mass and visceral fat area than women with inadequate PA. Higher average values of the fat-free mass, body cell mass and skeletal muscle mass were found in older women with adequate PA in comparison with women with inadequate PA. Conclusions: The research study verified a positive relationship between meeting the recommended PA level and its impact on body composition health risk indicators. A positive approach to the PA may lead to a decrease in health problems associated with excess weight and obesity.

  3. 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

  4. Application of absorption modeling to predict bioequivalence outcome of two batches of etoricoxib tablets.

    Science.gov (United States)

    Mitra, Amitava; Kesisoglou, Filippos; Dogterom, Peter

    2015-02-01

    As part of the overall product development and manufacturing strategy, pharmaceutical companies routinely change formulation and manufacturing site. Depending on the type and level of change and the BCS class of the molecule, dissolution data and/or bioequivalence (BE) may be needed to support the change for immediate release dosage forms. In this report, we demonstrate that for certain weakly basic low-solubility molecules which rapidly dissolve in the stomach, absorption modeling could be used to justify a BE study waiver even when there is failure to show dissolution similarity under some conditions. The development of an absorption model for etoricoxib is described here, which was then used to a priori predict the BE outcome of tablet batches manufactured at two sites. Dissolution studies in 0.01 N HCl media (pH 2.0) had demonstrated similarity of etoricoxib tablets manufactured at two different sites. However, dissolution testing at pH 4.5 and pH 6.8 media failed to show comparability of the tablets manufactured at the two sites. Single simulations and virtual trials conducted using the 0.01 N HCl dissolution showed similarity in AUC and C max for all tablet strengths for batches manufactured at the two manufacturing sites. These predicted results were verified in a definitive bioequivalence study, which showed that both tablet batches were bioequivalent. Since the development of traditional in vitro-in vivo correlations (IVIVC) for immediate release (IR) products is challenging, in cases such as etoricoxib, absorption modeling could be used as an alternative to support waiver of a BE study. PMID:25182387

  5. 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.

  6. Bioequivalence study of three ibuprofen formulations after single dose administration in healthy volunteers

    OpenAIRE

    Bramlage, Peter; Goldis, Adrian

    2008-01-01

    Background This phase I study was designed to determine the bioavailability and bioequivalence of 400 mg Eudorlin® extra* (Ibuprofen) in comparison to two reference formulations (400 mg Nurofen® forte and 400 mg Migränin® after single dose administration under fasting conditions in healthy subjects. Therefore the design of a randomized, open label, multiple sequence cross-over study with a wash-out period of 7–10 days was used. Results AUC0-t(last) and AUC0-∞ (90%CI) were within the 80 to 125...

  7. Pharmacokinetics and bioequivalence of ranitidine and bismuth derived from two compound preparations

    Institute of Scientific and Technical Information of China (English)

    Quan Zhou; Zou-Rong Ruan; Hong Yuan; Bo Jiang; Dong-Hang Xu

    2006-01-01

    AIM: To evaluate the bioequivalence of ranitidine and bismuth derived from two compound preparations.METHODS: The bioavailability was measured in 20healthy male Chinese volunteers following a single oral dose (equivalent to 200 mg of ranitidine and 220 mg of bismuth) of the test or reference products in the fasting state. Then blood samples were collected for 24 h.Plasma concentrations of ranitidine and bismuth were analyzed by high-performance liquid chromatography and inductively coupled plasma-mass spectrometry (ICPMS), respectively. The non-compartmental method was used for pharmacokinetic analysis. Log-transformed Cmax,AUC(0-t) and AUC(0-∞) were tested for bioequivalence using ANOVA and Schuirmann two-one sided t-test. Tmax was analyzed by Wilcoxon's test.RESULTS: Various pharmacokinetic parameters of ranitidine derived from the two compound preparations,including Cmax, AUC(0-t), AUC(0-∞), Tmax and T1/2, were nearly consistent with previous observations. These parameters derived from test and reference drug were as follows: Cmax(0.67 ± 0.21 vs 0.68 ± 0.22mg/L), AUC(0-t)(3.1 ± 0.6 vs 3.0 ± 0.7 mg/L per hour),AUC(0-∞)(3.3 ± 0.6 vs 3.2 ± 0.8 mg/L per hour),Tmax (2.3 ± 0.9 vs 2.1 ± 0.9 h) and T1/2 (2.8 ± 0.3 vs 3.1± 0.4 h). In addition, double-peak absorption profiles of ranitidine were found in some Chinese volunteers.For bismuth, those parameters derived from test and reference drug were as follows: Cmax (11.80 ± 7.36 vs 11.40 ± 6.55 μg/L),AUC(0-t) (46.65 ± 16.97 vs 47.03 ±21.49 μg/L per hour), Tmax (0.50 ± 0.20 vs 0.50 ± 0.20 h)and T1/2 (10.2 ± 2.3 vs 13.0 ± 6.9 h). Ninety percent of confidence intervals for the test/reference ratio of Cmax,AUC(0-t) and AUC(0-∞) derived from both ranitidine and bismuth were found within the bioequivalence acceptable range of 80%-125%. No significant difference was found in Tmax derived from both ranitidine and bismuth.CONCLUSION: The two compound preparations are bioequivalent and may be prescribed

  8. Assessment of polymorphic metabolite data in bioavailability/bioequivalence studies - considerations and challenges

    Directory of Open Access Journals (Sweden)

    Nuggehally R Srinivas

    2011-01-01

    Full Text Available Bioavailability (BA/ bioequivalence (BE studies are the cornerstone for the approval of generic drugs. While BA/BE assessment involving the pharmacokinetic data of the parent compound has been routinely performed, the introduction of the assessment of metabolite(s data, alone or in addition to parent compound, has also emerged. In this context, the assessment of BA/BE of metabolite(s may pose additional complexities and challenges, if the metabolic pathway is under the influence of a polymorphic enzyme. This communication provides brief perspectives on the challenges and study design considerations for the assessment of polymorphic metabolite in BA/BE studies.

  9. 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.

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

    International Nuclear Information System (INIS)

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

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

    Energy Technology Data Exchange (ETDEWEB)

    1993-01-27

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

  12. Batch-to-batch pharmacokinetic variability confounds current bioequivalence regulations: A dry powder inhaler randomized clinical trial.

    Science.gov (United States)

    Burmeister Getz, E; Carroll, K J; Jones, B; Benet, L Z

    2016-09-01

    Current pharmacokinetic (PK) bioequivalence guidelines do not account for batch-to-batch variability in study design or analysis. Here we evaluate the magnitude of batch-to-batch PK variability for Advair Diskus 100/50. Single doses of fluticasone propionate and salmeterol combinations were administered by oral inhalation to healthy subjects in a randomized clinical crossover study comparing three different batches purchased from the market, with one batch replicated across two treatment periods. All pairwise comparisons between different batches failed the PK bioequivalence statistical test, demonstrating substantial PK differences between batches that were large enough to demonstrate bio-inequivalence in some cases. In contrast, between-replicate PK bioequivalence was demonstrated for the replicated batch. Between-batch variance was ∼40-70% of the estimated residual error. This large additional source of variability necessitates re-evaluation of bioequivalence assessment criteria to yield a result that is both generalizable and consistent with the principles of type I and type II error rate control. PMID:27037630

  13. 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

  14. Microdialysis sampling for investigations of bioavailability and bioequivalence of topically administered drugs: current state and future perspectives

    DEFF Research Database (Denmark)

    Holmgaard, R; Nielsen, J B; Benfeldt, E

    2010-01-01

    is concluded by the current regulatory point of view. The future perspective includes further expansion and validation of the use of MD in the experimental and clinical setting as well as in the optimization of the method for regulatory purposes, i.e. the commercialization of bioequivalent, generic drug...

  15. 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....

  16. A COMPARATIVE BIOEQUIVALENCE STUDY OF SOME BRANDS OF OFLOXACIN BY URINE AND SALIVARY ANALYSIS IN INDIA

    Directory of Open Access Journals (Sweden)

    SHARMA A

    2010-09-01

    Full Text Available This study was aimed to assess the bioequivalence of randomly selected brands of ofloxacin tablets marketed in India. Bioavailability assessment was conducted by measuring the concentration of drugs in the urine as well as saliva and bioavailability data was presented as cumulative quantity of drugs recovered in urine in 24 hours. Simple and sensitive, accurate and economical spectrophotometric method was developed for the estimation of ofloxacin in urine and saliva samples using phosphate buffer (pH 6.8 at 288 nm. Microbiological assay technique was used to analyze urine samples. The linearity was obtained in the concentration range of 2-20 µg/ml for ofloxacin. The two different brands of ofloxacin with the strength of 200mg and 400mg each showed same minimum inhibitory concentration value against the test strain of Staphylococcus aureus of 0.468 µg /ml and 1.388 µg /ml respectively. The salivary ofloxacin concentration ratio was highly dependent on sampling time. The salivary half-lives showed significant correlation with each other while the area under curve of ofloxacin concentration in saliva failed to show significant correlation. The two brands of ofloxacin 200mg(X1-X2, 400mg(X3-X4 each in punjab (India exhibited same bioavailability data in vivo and can be said to be bioequivalents.

  17. 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. PMID:21432621

  18. Bioequivalence study of 8 mg ondansetron film-coated tablets in healthy Caucasian volunteers.

    Science.gov (United States)

    Rudzki, P J; Kaza, M; Leś, A; Gilant, E; Ksycińska, H; Serafin-Byczak, K; Troć, M; Raszek, J; Piątkowska-Chabuda, E; Skowrońska-Smolak, M; Tarasiuk, A; Wilkowska, E; Łazowski, T

    2014-04-01

    The aim of the study was to investigate the bioequivalence of a generic product of 8 mg film-coated tablets (test) to the branded product (reference) at the same strength in order to apply for regulatory approval. The secondary objective of the study was to compare the tolerability of both products. A double blinded, randomized, cross-over, 2-period, comparative study was conducted in healthy Caucasian volunteers under fasting conditions. A single oral dose administration of the test or reference product was followed by a 7-day wash-out period. The ondansetron concentration was determined using a validated high performance liquid chromatography with a UV detection method. The 90% confidence interval of the point estimate (test over reference products) for C(max) and AUC(0-t) fell within the 80.00-125.00% acceptance range. The results of the study indicate that the film-coated tablets of Ondatron 8 mg manufactured by Tarchomińskie Zakłady Farmaceutyczne Polfa S.A. (test product) are bioequivalent to those of Zofran manufactured by GlaxoSmithKline Export Ltd (reference product). Both products were well tolerated. PMID:24132707

  19. BIOEQUIVALENCE STUDY OF TWO BRANDS OF PHENYTOIN SODIUM 100MG FORMULATIONS IN HEALTHY ADULT MALE RABBITS

    Directory of Open Access Journals (Sweden)

    Saroj Nepal , Suhrid Banskota , Nirmal Marasini, Biki Gupta , Shyam Prasad Lohani , Shova Basnet and Bal Mukunda Regmi*

    2013-01-01

    Full Text Available The objective of the study was to compare the bioavailability of a single oral 100 mg dose of two brands of phenytoin sodium formulations available in the Nepalese market. Formulation B was taken as test drug and compared with the innovator brand which was taken as reference standard. A randomized, two-way crossover study was done in six healthy adult male rabbits. All six rabbits received a single oral 100 mg dose of both the formulations with a two-week washout period between the formulations. Blood samples for plasma phenytoin levels were collected at 0.25, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours. The pharmacokinetic parameters of the two brands of phenytoin sodium calculated were area under the concentration versus time curve from time zero to 24 hours (AUC 0–24, Area under the Curve from time zero to infinity (AUC0–∞, peak plasma concentration (Cmax and time of peak concentration (tmax. Formulation B failed to comply in terms of Area under the Curve (AUC, an important pharmacokinetic parameter to test bioequivalency, which was tested at significance level 0.05. This showed that the test formulation is not bioequivalent with the innovator. Taken together, our preliminary findings suggest that further studies in a large population is needed before switching phenytoin brands once a patient is carefully titrated to a given phenytoin brand.

  20. Intercambiabilidad de opioides y moléculas bioequivalentes Opioid switching and bioequivalent molecules

    Directory of Open Access Journals (Sweden)

    M.D. Rodrigo

    2010-03-01

    Full Text Available Ante la alerta creada por dos situaciones que inciden, de manera significativa, en el entorno de la actividad clínica de los médicos que tratan el dolor, y que son: por un lado, la intercambiabilidad de moléculas bioequivalentes y, por el otro, las directrices emitidas por alguna consejería de salud en el fomento del uso de morfina frente a otros opioides como analgésico opioide de primera elección, el Grupo de Trabajo de Opioides de la Sociedad Española del Dolor -considerando que ambas pueden llevar a actuaciones en la práctica clínica que no se ajustan a la evidencia científica disponible- analiza estos dos hechos a partir del informe de experto del Dr. Cecilio Álamo, realizado en mayo de 2009, sobre la intercambiabilidad clínica de opioides potentes. Tras una revisión en profundidad de la bibliografía disponible a nivel nacional e internacional, así como de la posición de instituciones sanitarias europeas, entre otras, la Agencia Francesa del Medicamento y la Royal Pharmaceutical Society del Reino Unido, emite las conclusiones siguientes: 1. No creemos justificada la intercambiabilidad de opioides potentes entre sí, ya sean genéricos o de marca. 2. Ante las ventajas que aportan las nuevas moléculas con diferentes formulaciones (tanto por vía oral como por vía transdérmica, podemos afirmar que hay otras opciones terapéuticas frente al uso de morfina como analgésico opioide de primera elección.Due to the alert created due to two important incidents that took place involving the clinical activity of doctors who treat pain (one is the switching of bioequivalent molecules, and the other is the directives issued by a Health Department on encouraging the use of morphine instead of other opioids as first choice analgesic opioid, the Working Group of the Spanish Pain Society, considering that both can affect the activities in clinical practices that do not adapt to the available scientific evidence, analysed these two facts

  1. Physical activity of female children and adolescents based on step counts: meeting the recommendation and relation to BMI

    Directory of Open Access Journals (Sweden)

    Kantanista Adam

    2015-06-01

    Full Text Available Study aim: the aim of this study was to assess the step counts of children and adolescents with different BMIs and to present the results in relation to the step count recommendation.

  2. 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.

  3. Physical Activity and Public Health in Older Adults: Recommendation from the American College of Sports Medicine and the American Heart Association

    Science.gov (United States)

    Objective: To issue a recommendation on the types and amounts of physical activity needed to improve and maintain health in older adults. Participants: A panel of scientists with expertise in public health, behavioral science, epidemiology, exercise science, medicine, and gerontology. Evidence: The ...

  4. 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.; Hees, L. van; 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 supraventricu

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-02-15

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

  6. Bioequivalence study of two oral tablet formulations containing saquinavir mesylate boosted with ritonavir in healthy male subjects.

    Science.gov (United States)

    Yerino, Gustavo A; Halabe, Emilia K; Zini, Elvira; Feleder, Ethel C

    2011-01-01

    Saquinavir (SAQ) mesylate (CAS 149845-06-7) is a potent inhibitor of the HIV-1 protease indicated in combination with other antiretrovirals for the management of HIV-1 infection. The objective of this study was to compare rate and extent of absorption and to assess the bioequivalence between a new pharmaceutical equivalent tablet formulation containing 500 mg of SAQ mesylate and the innovator film coated tablet formulation. A randomized, single-center, open-label, two-treatment, two-sequence, three-period, replicated crossover bioequivalence study in 40 healthy male subjects was conducted. All subjects received 100 mg ritonavir (CAS 155213-67-5) twice daily for a run-in period of 3 days before treatment. Dosing was separated by a wash-out period of 14 days. Blood samples were collected over 72 h and plasma levels of SAQ were determined by a validated HPLC/UV assay. The 90% confidence interval (CI) of the ratio of the geometric means for log-transformed C(max), AUC(last) and AUC(inf) values were used to assess bioequivalence using the equivalence interval of 80-125%. Point estimate and 90% CI of the ratios of C(max), AUC(last) and AUC(inf) values were 94.9 (80.9-111.3), 97.4 (82.4-115.4) and 97.4 (82.5-115.0), respectively. Both treatments exhibited similar tolerability and safety. It was concluded that the new pharmaceutical product was bioequivalent to the innovator. PMID:21950153

  7. 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.

  8. Physical activity recommendations for children with specific chronic health conditions: Juvenile idiopathic arthritis, hemophilia, asthma and cystic fibrosis

    OpenAIRE

    Philpott, J; Houghton, K.; Luke, A

    2010-01-01

    As a group, children with a chronic disease or disability are less active than their healthy peers. There are many reasons for suboptimal physical activity, including biological, psychological and social factors. Furthermore, the lack of specific guidelines for ‘safe’ physical activity participation poses a barrier to increasing activity. Physical activity provides significant general health benefits and may improve disease outcomes. Each child with a chronic illness should be evaluated by an...

  9. Saliva vs. plasma bioequivalence of metformin in humans: validation of class II drugs of the salivary excretion classification system.

    Science.gov (United States)

    Idkaidek, N; Arafat, T

    2014-11-01

    To study saliva and plasma bioequivalence of metformin in humans, and to investigate the robustness of using saliva instead of plasma as surrogate for bioequivalence of class II drugs according to the salivary excretion classification system (SECS).Plasma and saliva samples were collected for 12 h after 500 mg oral dosing of metformin to 16 healthy humans. Plasma and saliva pharmacokinetic parameters, 90% confidence intervals and intra-subject variability values were calculated using Kinetica V5. Descriptive statistics and dimensional analysis were calculated by Excel. SimCYP program V13 was used for estimation of effective intestinal permeability.Metformin was subjected to salivary excretion since it falls into class II (Low permeability/High fraction unbound to plasma proteins), with correlation coefficients of 0.95-0.99 between plasma and saliva concentrations. Saliva/plasma concentration ratios were 0.29-0.39. The 90% confidence limits of all parameters failed in both saliva and plasma. Intra-subject variability values in saliva were higher than plasma leading to need for higher number of subjects to be used in saliva.Saliva instead of plasma can be used as surrogate for bioequivalence of class II drugs according to SECS when adequate sample size is used. Future work is planned to demonstrate SECS robustness in drugs that fall into class III.

  10. 泛昔洛韦片在中国健康人体的生物等效性%Bioequivalence of famciclovir tablets in Chinese healthy volunteers

    Institute of Scientific and Technical Information of China (English)

    郭韶洁; 王淑民; 武峰; 李嘉静; 周辉; 赵秀丽

    2012-01-01

    目的 评价2种国产泛昔洛韦片在中国健康人体的生物等效性.方法 20名健康男性受试者随机交叉单剂量口服泛昔洛韦片试验药物或对照药物,各500 mg.用高效液相色谱法测定血浆中喷昔洛韦浓度;用DAS 2.0软件计算药代动力学参数,并对2种药物进行生物等效性评价.结果 试验药物和对照药物的药代动力学参数:Cmax分别为(2.60±0.53)和(3.50 ±0.84)mg·L-1;Tmax 分别为(0.99±0.45)和(2.50±0.23)h;t1/2分别为(2.52±0.32)和(2.50±0.23);AUC0-t分别为(9.10±1.61)和(9.61±1.70)mg·h·L-1.AUC0-t、AUC0-∞、Cmax的90%可信区间分别为90.7%~ 99.0%、90.9%~99.6%和70.4%~ 80.6%.试验药物相对于对照药物的生物利用度F为(95.29±9.85)%.结论 试验药物和对照药物生物等效.%Objective To evaluate the bioequivalent of test tablet and reference tablet of famciclovir in Chinese volunteers. Method In self -control and two - way crossover design, 20 healthy male volunteers were divided into two groups at random. Each subject was given 500 mg of the test tablet and reference tablet of famciclovir respectively at single dose. Plasma concentrations of penciclovir ( active metabolin) were determined by HPLC method. The pharmacokinetic parameters were calculated with DAS statistic software, the bioequivalent of famciclovir tablet evaluated as well. Results The main pharmacokinetic parameters of famciclovir test tablet and reference tablet were as follows: C^ ( 2. 60 ± 0. 53 ) , ( 3. 50 ±0.84) mg·L-1; Tmax,(0. 99 ±0.45), (2.50±0.23) h ; t1/2(2.52 ±0.32),(2. 50 ±0. 23) h; AUC0_t(9. 10 ±1.61), (9.61 ±1.70)mg ? H ? L~ , respectively. The relative bioavailability of famciclovir test tablet was (95. 29 ± 9. 85)% . Conclusion The test tablet and reference tablet of famciclovir were bioequivalent.

  11. ICRS Recommendation Document

    DEFF Research Database (Denmark)

    Roos, Ewa M.; Engelhart, Luella; Ranstam, Jonas;

    2011-01-01

    , and confirmatory longitudinal studies are needed prior to recommending this scale for use in cartilage repair. Inclusion of a generic measure is feasible in cartilage repair studies and allows analysis of health-related quality of life and health economic outcomes. The Marx or Tegner Activity Rating Scales...... constructs at all levels according to the International Classification of Functioning. Conclusions: Because there is no obvious superiority of either instrument at this time, both outcome measures are recommended for use in cartilage repair. Rescaling of the Lysholm Scoring Scale has been suggested......Abstract Objective: The purpose of this article is to describe and recommend patient-reported outcome instruments for use in patients with articular cartilage lesions undergoing cartilage repair interventions. Methods: Nonsystematic literature search identifying measures addressing pain...

  12. 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

  13. Physical activity recommendations for children with specific chronic health conditions: Juvenile idiopathic arthritis, hemophilia, asthma and cystic fibrosis.

    Science.gov (United States)

    Philpott, J; Houghton, K; Luke, A

    2010-04-01

    As a group, children with a chronic disease or disability are less active than their healthy peers. There are many reasons for suboptimal physical activity, including biological, psychological and social factors. Furthermore, the lack of specific guidelines for 'safe' physical activity participation poses a barrier to increasing activity. Physical activity provides significant general health benefits and may improve disease outcomes. Each child with a chronic illness should be evaluated by an experienced physician for activity counselling and for identifing any contraindications to participation. The present statement reviews the benefits and risks of participation in sport and exercise for children with juvenile arthritis, hemophilia, asthma and cystic fibrosis. Guidelines for participation are included. PMID:21455465

  14. Recommendations and the state of the evidence for physical activity interventions for adults with rheumatoid arthritis: 2007 to present

    OpenAIRE

    Iversen, Maura D.; Brawerman, Marisa; Iversen, Christina N

    2012-01-01

    Patients with rheumatoid arthritis (RA) are twice as likely as their healthy peers to suffer from cardiovascular disease. RA is also a major cause of disability and reduced quality of life. Clinical trials of exercise and physical activity interventions demonstrate positive effects on muscle strength, function, aerobic capacity, mood and disability. While RA management guidelines emphasize the role of exercise and physical activity in the management of RA, the description of physical activity...

  15. A perspective for biowaivers of human bioequivalence studies on the basis of the combination of the ratio of AUC to the dose and the biopharmaceutics classification system.

    Science.gov (United States)

    Sakuma, Shinji; Tachiki, Hidehisa; Uchiyama, Hitoshi; Fukui, Yasunobu; Takeuchi, Naohiro; Kumamoto, Kazuo; Satoh, Tomonori; Yamamoto, Yoshinobu; Ishii, Emi; Sakai, Yoshiyuki; Takeuchi, Susumu; Sugita, Masaru; Yamashita, Shinji

    2011-08-01

    The ratio of AUC to the dose (AUC/dose) was previously found as a parameter that predicts a risk of bioinequivalence of oral drug products. On the basis of the combination of this parameter and the biopharmaceutics classification system (BCS), a perspective for biowaivers of human bioequivalence studies is discussed. Databases of bioequivalence studies using immediate-release solid oral dosage forms were disclosed by 6 Japanese generic pharmaceutical companies, and the number of subjects required for demonstrating bioequivalence between generic and reference products was plotted as a function of AUC/dose for each BCS category. A small variation in the number of subjects was constantly observed in bioequivalence studies using dosage forms containing an identical BCS class 1 or class 3 drug, even though formulations of the generic product differ between companies. The variation was extremely enlarged when the drugs were substituted with BCS class 2 drugs. Rate-determining steps in oral absorption of highly water-soluble BCS class 1 and class 3 drugs are independent of formulations when there is no significant difference in the in vitro dissolution profiles between formulations. The small variation observed for both BCS categories indicates that the number of subjects converges into one value for each drug. Our analysis indicates the appropriateness of biowaiver of bioequivalence studies for immediate-release solid oral dosage forms containing not only BCS class 1 drugs but also class 3 drugs. PMID:21630662

  16. 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.

  17. Bioequivalence Study of Two Long-Acting Formulations of Oxytetracycline Following Intramuscular Administration in Bovines

    Science.gov (United States)

    Mestorino, Nora; Marchetti, María Laura; Lucas, Mariana Florencia; Modamio, Pilar; Zeinsteger, Pedro; Fernández Lastra, Cecilia; Segarra, Ignacio; Mariño, Eduardo Luis

    2016-01-01

    The aim of this study was to evaluate the bioequivalence of two commercial long-acting formulations based on oxytetracycline (OTC) hydrochloride between the reference formulation (Terramycin LA, Pfizer) and a test formulation (Cyamicin LA, Fort Dodge Saude Animal). Both formulations were administered in a single intramuscular route at a dose of 20 mg OTC/kg of body weight in clinically healthy bovines. The study was carried out according to a one-period parallel design. Plasma samples were analyzed by high-pressure liquid chromatography. The limit of quantitation was 0.050 μg/mL with an accuracy of 101.67% with a coefficient of variation of 13.15%. Analysis of variance and 90% confidence interval tests were used to compare the bioavailability parameters (maximum plasma concentration, Cmax, and the area under the concentration-versus-time curve extrapolated to infinity, AUC0–∞) of both products. In the case of the time to maximum concentration (Tmax), non-parametric tests based on Wilcoxon’s signed rank test were preferred. The comparison of the mean AUC0–∞ values did not reveal any significant differences (311.40 ± 93.05 μg h/mL and 287.71 ± 45.31 μg h/mL, respectively). The results were similar for the Tmax (3.58 ± 0.90 h versus 3.42 ± 0.51 h). However, when comparing the mean Cmax some significant differences were found (8.73 ± 3.66 μg/mL and 10.43 ± 3.84 μg/mL, respectively). The 90% confidence intervals for the ratio of AUC0–∞ and Tmax values for the reference and test product are within the interval 80–125%, but the 90% confidence intervals for the ratio of Cmax falls outside the proposed interval. It was concluded that Cmax of test product are not within the 20% of those of the reference, thus suggesting that test OTC is not bioequivalent to the reference formulation. PMID:27446938

  18. 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

    2015-12-01

    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 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 high intrasubject variability in oral drug absorption. This information is of importance to design the human BE

  19. 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

    ... Activity, and Obesity, Centers for Disease Control and Prevention, 4770 Buford Highway NE., MS-K46, Atlanta..., Physical Activity, and Obesity, Centers for Disease Control and Prevention, 4770 Buford Highway NE., MS-K46..., attractive and convenient places to walk (and wheelchair roll) and creating a culture that supports...

  20. Predictors of Meeting Physical Activity and Fruit and Vegetable Recommendations in 9-11-Year-Old Children

    Science.gov (United States)

    Beck, Jimikaye; De Witt, Peter; McNally, Janise; Siegfried, Scott; Hill, James O; Stroebele-Benschop, Nanette

    2015-01-01

    Objective: Childhood obesity represents a significant public health problem. This study examined physical activity and nutrition behaviours and attitudes of 9-11-year-olds, and factors influencing these behaviours. Design: Study participants recorded pedometer steps for 7 days and completed physical activity enjoyment, food attitudes and food…

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

    Directory of Open Access Journals (Sweden)

    Bettina M. Ruppelt

    1991-01-01

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

  2. Collective knowledge: using a consensus conference approach to develop recommendations for physical activity and nutrition programs for persons with type 2 diabetes

    Science.gov (United States)

    Berry, Tanya R.; Chan, Catherine B.; Bell, Rhonda C.; Walker, Jessica

    2012-01-01

    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-min 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. PMID:23248617

  3. 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.

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

    DEFF Research Database (Denmark)

    Mattsson, Jan; Söderlund, Magnus

    encounters) to provide WOM would have a positive impact on WOM activity. We base this assumption on the question-behavior effect identified with regard to questions in questionnaires, on reciprocity theory, and on arguments related to customer benefits that may be evoked by a request for WOM. This purpose...

  5. Acute genital ulcers in nonsexually active young girls: case series, review of the literature, and evaluation and management recommendations.

    Science.gov (United States)

    Rosman, Ilana S; Berk, David R; Bayliss, Susan J; White, Andrew J; Merritt, Diane F

    2012-01-01

    Acute genital ulcers rarely occur in nonsexually active young girls. When present, they can cause significant physical and emotional distress for the patient and her parents, and prompt an evaluation for sexual abuse and sexually transmitted diseases. With this review, we aim to further characterize acute genital ulcers in nonsexually active young girls by reviewing the medical records of patients with this disorder and to offer an approach to the diagnosis, evaluation, and treatment of acute genital ulcers based on our understanding and knowledge of this condition. We retrospectively review our understanding and knowledge of acute genital ulcers in nonsexually active girls at a pediatric hospital. A review of the recent literature on acute genital ulcers and a multidisciplinary approach to the diagnosis, evaluation, and treatment of acute genital ulcers are also presented. Twelve patients presented with acute genital ulcers, 11 of which were hospitalized for evaluation and pain management. Extensive work-up failed to reveal a specific infectious or autoimmune etiology in all but one patient, who was diagnosed with acute mycoplasma pneumonia. Acute genital ulcers in nonsexually active young girls likely represent a form of idiopathic vulvar aphthosis. Evaluation of a first episode of acute genital ulcers with mild prodromal symptoms should be limited. Treatment consists primarily of supportive care and symptom relief.

  6. Chronic inflammatory demyelinating polyneuropathy disease activity status: recommendations for clinical research standards and use in clinical practice

    NARCIS (Netherlands)

    K.C. Gorson; I.N. van Schaik; I.S.J. Merkies; R.A. Lewis; R.J. Barohn; C.L. Koski; D.R. Cornblath; R.A.C. Hughes; A.F. Hahn; M. Baumgarten; J. Goldstein; J. Katz; M. Graves; G. Parry; P.A. van Doorn

    2010-01-01

    Defining long-term outcomes in chronic inflammatory demyelinating polyneuropathy (CIDP) has been complicated by varying definitions of treatment response and differing scales measuring impairment or disability. An expert panel was convened to devise a CIDP Disease Activity Status (CDAS) and to class

  7. 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.

  8. Saliva versus plasma bioequivalence of rusovastatin in humans: validation of class III drugs of the salivary excretion classification system.

    Science.gov (United States)

    Idkaidek, Nasir; Arafat, Tawfiq

    2015-03-01

    Bioequivalence of rusovastatin in healthy human volunteers was done using saliva and plasma matrices in order to investigate the robustness of using saliva instead of plasma as a surrogate for bioequivalence of class III drugs according to the salivary excretion classification system (SECS). Saliva and plasma samples were collected for 72 h after oral administration of rusovastatin 40 mg to 12 healthy humans. Saliva and plasma pharmacokinetic parameters were calculated by non-compartmental analysis. Analysis of variance, 90 % confidence intervals, and intra-subject and inter-subject variability values of pharmacokinetic parameters were calculated using Kinetica program V5. Human effective intestinal permeability was also calculated by SimCYP program V13. Rusovastatin falls into class III (high permeability/low fraction unbound to plasma proteins) and hence was subjected to salivary excretion. A correlation coefficient of 0.99 between saliva and plasma concentrations, and a saliva/plasma concentration ratio of 0.175 were observed. The 90 % confidence limits of area under the curve (AUClast) and maximum concentration (C max) showed similar trends in both saliva and plasma. On the other hand, inter- and intra-subject variability values in saliva were higher than in plasma, leading to the need for a slightly higher number of subjects to be used in saliva studies. Non-invasive saliva sampling instead of the invasive plasma sampling method can be used as a surrogate for bioequivalence of SECS class III drugs when an adequate sample size is used.

  9. 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 BACKGROUND: 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. METHODS: 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. FINDINGS: 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. CONCLUSIONS: 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.

  10. High-Performance Liquid Chromatographic-Tandem Mass Spectrometric Determination of Itraconazole in Human Plasma for Bioavailability and Bioequivalence Studies

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Young Wook; Nam, Dae Young; Kang, Kyoung Hoon; Ha, Kyung Wook; Han, In Hee; Chang, Byung Kon; Yoon, Mi Kyeong; Lee, Jae Hwi [Chung-Ang University, Seoul (Korea, Republic of)

    2006-02-15

    A highly sensitive high-performance liquid chromatographic-tandem mass spectrometric method (HPLC-MSMS) has been developed to quantify itraconazole in human plasma for the purpose of pharmacokinetic studies. Sample preparation was carried out by liquid-liquid extraction using loratadine as an internal standard. Chromatographic separation used a YMC C{sub 18} column, giving an extremely fast total run time of 3 min. The method was validated and used for the bioequivalence study of itraconazole tablets in healthy male volunteers (n = 31). The lower limit of detection proved to be 0.2 ng /mL for itraconazole.

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

    Science.gov (United States)

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

    2009-01-01

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

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

    Science.gov (United States)

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

    2009-01-01

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

  13. Radiological protection principles to be applied to the preservation and use of tailing dams resulting from mining activities. Recommendation of the Radiation Protection Commission (SSK), passed at its 105th meeting on October 7/8, 1991

    International Nuclear Information System (INIS)

    The Recommendation refers to tailing dams in the new Lands of the Federal Republic of Germany resulting from uranium mining and other mining activities. The Recommendation involves the preservation and the use of these grounds for forestry and agriculture, or as sites for residential, public or industrial buildings. The maximum permissible, specific activities are defined in order to protect the population from hazards of radioactivity. (orig./HP)

  14. 78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-11-06

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... recommendations for comment. Recommendations were last announced in the Federal Register on June 20, 2013 (78 FR... Draft Product-Specific BE Recommendations for Drug Products B Bedaquiline fumarate....

  15. BIOEQUIVALENCE BETWEEN rhGH FOR RECONSTITUTION AND READY-TO-USE rhGH IN TWO LIQUID FORMULATIONS

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    Objective To evaluate the bioequivalence between recombinant human growth hormone ( rhGH) for reconstitution, and two dosages of liquid formulation of rhGH [ (15IU)5mg or ( 30IU) l0mg per 3ml].Methods The study drugs were tested in a randomized, single-blind and three-period crossover studies in 24 healthy male subjects. The three drugs were administered by subcutaneous injection at a dose of 0. 2IU/kg body weight. A continuous somatostatin infusion was given in order to suppress the secretion of endogenous GH. The venous blood samples were drawn at different time points to test the serum concentration of GH. The pharmacokinetic parameters were analyzed by statistical methods. Results 90% confidence intervals (CI) of AUC0-24h among three products were all within 80% -125% interval (103.4% -116. 5%, 105. 7% -119. 6% and 91.9% -103. 7%,respectively), and the CIs of Cmax among three products were all within 70%-143% interval ( 91.9%-114. 0%,103. 7%-127. 2% and 81.6%-97. 4%, respectively). There was no statisitical difference of tmax among all the three products. Conclusion These data demonstrate that there is bioequivalence between rhGH for reconstitution and two liquid formulations of rhGH.

  16. 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. PMID:25869458

  17. Bioequivalence evaluation of two roxithromycin formulations in healthy human volunteers by high performance liquid cromatography coupled to tandem mass spectrometry.

    Science.gov (United States)

    Motta, M; Ribeiro, W; Ifa, D R; Moares, M E; Moraes, M O; Corrado, A P; De Nucci, G

    1999-01-01

    The bioequivalence of two different formulations containing roxithromycin (SPE-712-1). Oral suspension 300 mg/15 mL as test formulation and Rotram, tablets 300 mg as reference formulation, both by Schering Plough S.A., Brazil) was evaluated in 24 healthy volunteers of both sexes (12 male and 12 female). The study was conducted open with randomized two-period crossover design and a 14-day washout period. Each subject received 300 mg of each roxithromycin formulation. Plasma samples were obtained over a 72-hour interval and roxithromycin concentrations were analyzed by combined LC-MS/MS with positive ion electrospray ionization using selected ion monitoring method. From the plasma roxithromycin concentration vs time curves the following pharmacokinetic parameters were obtained: AUC(0-72 h), AUC(0-infinity), Cmax, t1/2 ratios and tmax individual differences. The 90% for confidence interval (CI) of geometric mean SPE-712-L/Rotram individual percent ratio were 105.0-128.3% for AUC(0-72 h), and 78.4-96.9 for Cmax. Although this 90% CI were marginally outside the interval proposed by the Food and Drug Administration, the probability assessed by the two-one sided West for ratios was included in the 0.8-1.25 interval, as we concluded that SPE-712-L oral suspension formulation was bioequivalent to Rotram tablet formulation for the extent and rate of absorption. PMID:10797866

  18. 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. PMID:26794937

  19. Avoiding congestion in recommender systems

    International Nuclear Information System (INIS)

    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)

  20. Bioequivalence of two metformin formulations: 850 mg tablets in healthy colombian volunteers Bioequivalencia de dos formulaciones de metformina, tabletas de 850 mg, en voluntarios sanos colombianos

    Directory of Open Access Journals (Sweden)

    Ómar de Jesús Correa Cano

    2005-03-01

    Full Text Available Introduction: Metformin is an orally active antidiabetic agent used to treat type II diabetes; it is found in the Colombian market in both the innovator brand and the generic formulations. The latter have to prove some biopharmaceutical quality outcomes to guarantee interchangeable proprieties. Objective: To determine whether the drug Dimefor®/Metformina MK is bioequivalent to the reference product Glucophage®, when the products are administrated, at the same dose, to a group of healthy volunteers. Method: The study was made with 24 healthy volunteers who met the inclusion criteria and spontaneously decided to participate after being thoroughly informed. We used a two-sequence threeperiod randomized, crossed and double-blind study. The volunteers took an 850 mg dose of each medicine; then, blood samples were taken throughout 24 hours and the metformin quantification in plasma was determined by High Performance Liquid Chromatography with UV detection (HPLC/UV. For statistical analysis, Schuirmann’s test was used. Results: The study showed that both preparations are bioequivalent; confidence intervals for ln AUC0-∞, ln Cmax, ln AUC0-Tmax and Tmax were [84.6-100.0%], [89.1-109.0%], [83.4–01.4%] and [85.1-109.8% ], respectively. Introducción: la metformina es un antihiperglicemiante útil en el manejo de la diabetes mellitus tipo II, del que se encuentran en el mercado colombiano tanto el producto innovador como diferentes formulaciones genéricas. Para garantizar la seguridad y eficacia de estas últimas, es necesario demostrar su bioequivalencia con respecto al producto innovador. Objetivo: determinar si el producto Dimefor®/Metformina MK es bioequivalente con el producto Glucophage® (referencia cuando se administran en dosis iguales a un grupo de voluntarios sanos. Método: el estudio se realizó sobre veinticuatro voluntarios que cumplieron con los requisitos de inclusión y decidieron participar espontáneamente después de ser

  1. 77 FR 56851 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-09-14

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... recommendations for comment. Recommendations were last announced in the Federal Register of June 14, 2012 (77 FR... Thalidomide Tretinoin (multiple RLDs and dosage forms) III. Drug Products for Which Revised Draft...

  2. Microdialysis sampling for investigations of bioavailability and bioequivalence of topically administered drugs: current state and future perspectives

    DEFF Research Database (Denmark)

    Holmgaard, R; Nielsen, J B; Benfeldt, E

    2010-01-01

    Microdialysis (MD) in the skin is a unique technique for in vivo sampling of topically as well as systemically administered drugs at the site of action, e.g. sampling the unbound tissue concentrations in the dermis and subcutaneous tissue. MD as a research method has undergone significant...... instrumentation, calibration and experimental procedures are discussed along with the analytical considerations necessary for successful sampling. Clinical MD studies in the skin are reviewed with emphasis on pharmacokinetic studies of topically applied drugs with or without impairment of skin barrier function by...... skin disease or barrier perturbation. A comparison between MD and other tissue sampling techniques reveals the advantages and limitations of the method. Subsequently, an in-depth discussion of the application of MD for the evaluation of bioavailability and bioequivalence of topical formulations is...

  3. Application of rapid and simple liquid chromatography method for determination of bioequivalence of generic lamotrigine tablets in healthy Iranian volunteers

    Directory of Open Access Journals (Sweden)

    Samira Sadat Abolmaali

    2015-09-01

    Full Text Available A simple and rapid chromatography method was developed for determination of lamotrigine in human plasma. The method was used to compare the pharmacokinetic (PK parameters of 50 mg generic and the reference lamotrigine (Lamictal tablets in healthy Iranian volunteers. High performance liquid chromatography-ultraviolet method was developed and validated to determine lamotrigine concentration in plasma samples. The method was linear over the range of 0.1 to 15 μg/ml. The accuracy and precision were within the acceptable range. Limits of detection and quantification were calculated 0.06 and 0.10 μg/mL, respectively. A randomized, single-dose, two-period, two-sequence crossover study was carried out in healthy subjects receiving either the test or the reference products in each period. Pharmacokinetic parameters were determined using non-compartmental calculations. In vivo bioequivalency between the generic and the reference product was investigated according to the guidance for industry issued by US Food Drug Administration. AUC0-t, AUC0-∞ and Cmax were calculated for the generic product 12.50±2.76 μg.h/mL, 15.04±3.66 μg.h/mL and 0.38±0.08 μg/mL, respectively. The 90% confidence interval for the test/reference ratios were laid in the range of 0.80-1.25 for the log-transformed PK parameters. The generic product is bioequivalent and can be prescribed by practitioners while indicated, however the AUC and Cmax were lower in Iranian population if compared to the literature, which requires further investigations.

  4. 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

  5. 内源性物质药物生物等效性评价的探讨%Review on the methods assessing the bioequivalence of endogenous substances

    Institute of Scientific and Technical Information of China (English)

    曹国颖; 朱孔彩; 胡欣

    2012-01-01

    Assessment of the bioequivalence of drugs made of endogenous substances is complicated because it is difficult to distinguish the externally administered drugs with the endogenous ones following drug administration. A literature search of the PubMed and Wanfang databases was performed, and the commonly used bioequivalence assessment methods are reviewed in this article.%内源性物质是体内已有的物质,内源性物质药物生物等效性的评价因为体内自身物质的存在变得复杂化.文中以内源性物质和生物等效性为关键词,检索Pubmed和万方数据库,对常用的内源性物质药物的生物等效性评价方法进行了综述.

  6. Bioequivalence evaluation of two amlodipine salts, besylate and orotate, each in a fixed-dose combination with olmesartan in healthy subjects

    Directory of Open Access Journals (Sweden)

    Lee SY

    2015-06-01

    Full Text Available Soo-Yun Lee,1 Jung-Ryul Kim,2,3 Jin Ah Jung,4 Wooseong Huh,2,5 Mi Young Bahng,6 Jae-Wook Ko1,2 1Department of Health Sciences and Technology, SAIHST, Sungkyunkwan University, Seoul, Republic of Korea; 2Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea; 3Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, Republic of Korea; 4Department of Clinical Pharmacology, Inje University, Busan Paik Hospital, Busan, Republic of Korea; 5Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 6Dong-A ST Co., Ltd., Seoul, Republic of Korea Abstract: A fixed-dose combination of amlodipine and olmesartan is used to treat high blood pressure in patients whose hypertension is not sufficiently controlled with either drug alone. The objective of this study was to evaluate the bioequivalence of two fixed-dose combinations, ie, amlodipine orotate/olmesartan medoxomil 10/40 mg and amlodipine besylate/olmesartan medoxomil 10/40 mg, in healthy subjects. A randomized, open-label, single-dose, two-sequence, two-period, crossover study was conducted in 30 healthy adult volunteers. Blood samples were collected for up to 72 hours post-dose in each period. Safety data included the results of physical examinations, clinical laboratory tests, vital signs, an electrocardiogram, and adverse events. For both amlodipine and olmesartan, the 90% confidence intervals for the geometric mean ratios of AUClast and time to peak plasma concentration fell within the bioequivalence acceptance criteria. The two fixed-dose combinations showed similar safety profiles. Amlodipine orotate/olmesartan medoxomil 10/40 mg was bioequivalent to amlodipine besylate/olmesartan medoxomil 10/40 mg. Keywords: amlodipine orotate, amlodipine besylate, olmesartan medoxomil, fixed-dose combination, bioequivalence

  7. Reverse-phase liquid chromatography with electrospray ionization/mass spectrometry for the quantification of pseudoephedrine in human plasma and application to a bioequivalence study.

    Science.gov (United States)

    Kim, Jin-Ki; Jee, Jun-Pil; Park, Jeong-Sook; Kim, Hyung Tae; Kim, Chong-Kook

    2011-01-01

    A sensitive and selective reverse-phase liquid chromatography electrospray ionization mass spectrometry (LC-ESI-MS) method was developed and validated to quantify pseudoephedrine (CAS 90-82-4) in human plasma. Phenacetin was used as the internal standard (I.S.). Sample preparation was performed with a deproteinization step using acetonitrile. Pseudoephedrine and I.S. were successfully separated using gradient elution with 0.5% trifluoroacetic acid (TFA) in water and 0.5% TFA in methanol at a flow-rate of 0.2 mL/min. Detection was performed on a single quadrupole mass spectrometer by a selected ion monitoring (SIM) mode via electrospray ionization (ESI) source. The ESI source was set at positive ionization mode. The ion signals of m/z 166.3 and 180.2 were measured for the protonated molecular ions of pseudoephedrine and I.S., respectively. The lower limit of quantification (LLOQ) of pseudoephedrine in human plasma was 10 ng/mL and good linearity was observed in the range of concentrations 10-500 ng/mL (R2 = 1). The intra-day accuracy of the drug containing plasma samples was more than 97.60% with a precision of 3.99-11.82%. The inter-day accuracy was 99.36% or more, with a precision of 7.65-18.42%. By using this analytical method, the bioequivalence study of the pseudoephedrine preparation was performed and evaluated by statistical analysis of the log transformed mean ratios of pharmacokinetic parameters. All the results fulfilled the standard criteria of bioequivalence, being within the 80-125% range which is required by the Korea FDA, US FDA, and EMEA to conclude bioequivalence. Consequently, the developed reverse-phase LC-ESI-MS method was successfully applied to bioequivalence studies of pseudoephedrine in healthy male volunteers.

  8. Bioequivalence of Alendronate and Vitamin D3 in a Combination Tablet Versus Corresponding-Dose Individual Tablets in Healthy Taiwanese Volunteers, Determined Using a Novel Plasma Alendronate Assay

    Directory of Open Access Journals (Sweden)

    D. Hamish Wright, PhD

    2015-12-01

    Conclusions: The combination tablet was considered bioequivalent to coadministration based on ALN AUC0–∞ and unadjusted vitamin D3 parameters. Slight differences for ALN AUC0–last and Cmax (upper 90% CIs outside the bounds were not considered clinically significant. The combination tablet was well tolerated. No serious adverse experiences were reported. © 2015. The Authors. Published by Elsevier Inc. All rights reserved.

  9. Bioequivalence evaluation of two amlodipine salts, besylate and orotate, each in a fixed-dose combination with olmesartan in healthy subjects.

    Science.gov (United States)

    Lee, Soo-Yun; Kim, Jung-Ryul; Jung, Jin Ah; Huh, Wooseong; Bahng, Mi Young; Ko, Jae-Wook

    2015-01-01

    A fixed-dose combination of amlodipine and olmesartan is used to treat high blood pressure in patients whose hypertension is not sufficiently controlled with either drug alone. The objective of this study was to evaluate the bioequivalence of two fixed-dose combinations, ie, amlodipine orotate/olmesartan medoxomil 10/40 mg and amlodipine besylate/olmesartan medoxomil 10/40 mg, in healthy subjects. A randomized, open-label, single-dose, two-sequence, two-period, crossover study was conducted in 30 healthy adult volunteers. Blood samples were collected for up to 72 hours post-dose in each period. Safety data included the results of physical examinations, clinical laboratory tests, vital signs, an electrocardiogram, and adverse events. For both amlodipine and olmesartan, the 90% confidence intervals for the geometric mean ratios of AUClast and time to peak plasma concentration fell within the bioequivalence acceptance criteria. The two fixed-dose combinations showed similar safety profiles. Amlodipine orotate/olmesartan medoxomil 10/40 mg was bioequivalent to amlodipine besylate/olmesartan medoxomil 10/40 mg.

  10. 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.

  11. 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......, and reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After...... and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials...

  12. 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 (<3 MET-h) on 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

  13. When are recommender systems useful?

    CERN Document Server

    Blattner, Marcel; Laureti, Paolo

    2007-01-01

    Recommender systems are crucial tools to overcome the information overload brought about by the Internet. Rigorous tests are needed to establish to what extent sophisticated methods can improve the quality of the predictions. Here we analyse a refined correlation-based collaborative filtering algorithm and compare it with a novel spectral method for recommending. We test them on two databases that bear different statistical properties (MovieLens and Jester) without filtering out the less active users and ordering the opinions in time, whenever possible. We find that, when the distribution of user-user correlations is narrow, simple averages work nearly as well as advanced methods. Recommender systems can, on the other hand, exploit a great deal of additional information in systems where external influence is negligible and peoples' tastes emerge entirely. These findings are validated by simulations with artificially generated data.

  14. Pharmacokinetics and bioequivalence of sibutramine dripping pills in healthy volunteers%盐酸西布曲明滴丸人体药动学和生物等效性

    Institute of Scientific and Technical Information of China (English)

    董海军; 李见春; 赵明霞; 张俊东; 刘胜利; 高署

    2009-01-01

    OBJECTIVE To investigate the pharmacokinetics and relative bioavailability of sibutramine dripping pills and cap-sules in healthy volunteers and evaluate the bioequivalence. METHODS A single oral dose of 15 mg test and reference sibutra-mine dripping pills or capsules was given to 20 male healthy volunteers in a randomized, two-way crossover study. The concen-tration of one of active metabolite of sibutramine in plasma was determined by LC-MS/MS. The pharmacokinetics parameters and relative bioavailability were calculated with DAS 2. 0 software to evaluate the bioequivalence of the two preparations. RE-SULTS The main pharmacokinetics parameters of test and reference preparations were as follows: t1/2 (20. 8±6. 0) h and and reference granules were not significant. The relative bioavailability of F was(96. 4±18. 2)%. CONCLUSION The statisti-cal analysis of the results shows that the two preparations are bioequivalent.%目的:研究盐酸西布曲明滴丸在健康人体的药动学和相对生物利用度并求证其生物等效性.方法:男性健康志愿者20名,随机交叉单剂量口服受试制剂盐酸西布曲明滴丸和参比制剂盐酸西布曲明胶囊各15 mg,采用高效液相色谱-质谱联用法测定血浆中西布曲明的活性代谢产物之一双去甲基西布曲明的浓度.计算药动学参数和相对生物利用度,评价其生物等效性.结果:口服受试和参比制剂后的主要药动学参数经统计矩参数计算:试验制剂t1/2为(20.8±6.0)h和(21.2±6.2)h;tmax峨为(4.2±1.0)h和(4.8±1.2)h;Cmax为(7.3±2.1)μg·L-1和(7.6±2.0)μg·L-1;AUC0-96 h为(159.5±56.4)μg·h·L-1和(168.4±57.3)μg·h·L-1,受试制剂与参比制剂比较的相对生物利用度F为(96.4±18.2)%.结论:两制剂具有生物等效性.

  15. Exploration in Interactive Personalized Music Recommendation: A Reinforcement Learning Approach

    OpenAIRE

    Wang, Xinxi; Wang, Yi; Hsu, David; Wang, Ye

    2013-01-01

    Current music recommender systems typically act in a greedy fashion by recommending songs with the highest user ratings. Greedy recommendation, however, is suboptimal over the long term: it does not actively gather information on user preferences and fails to recommend novel songs that are potentially interesting. A successful recommender system must balance the needs to explore user preferences and to exploit this information for recommendation. This paper presents a new approach to music re...

  16. Pharmacokinetics and bioequivalence evaluation of Gatifloxacin Capsules%加替沙星胶囊的药代动力学及生物等效性评价

    Institute of Scientific and Technical Information of China (English)

    苏冀红; 李奇矩

    2011-01-01

    Objective: To evaluate the pharmacokinetics and bioequivalence of Gatifloxacin Capsules in the healthy male.Methods: 40 healthy male were randomly divided into two groups, there were respectively given domestic and imported oral Gatifloxacin Capsules, used the high performance liquid chromatography method for detected the Catifloxacin concentrations in plasma, and analyzed the major drug pharmacokinetic parameters and evaluated the bioequivalence of two formulations. Results: The oral administration of domestic and imported in the two groups after gatifloxacin's half-life,peak time, peak concentration and the lag time had not significant different. Bioequivalence compared with the same time had no significant difference, so we thought thaL the two formulations were bioequivalent. Conclusion: Domestic and imported Catifloxacin Capsules preparation or reference test preparation in healthy volunteers are bioequivalent and similar pharmacokinetics.%目的:评价加替沙星胶囊在健康男性体内的药代动力学和生物等效性.方法:40例健康男性试验者随机平分为两组.分别口服国产与进口加替沙星胶囊试验制剂或参比制剂,采用高效液相色谱法测定血浆中加替沙星的浓度,计算主要药代动力学参数,评价两制剂的生物等效性.结果:口服国产和进口加替沙星后两组的半衰期、峰时间、峰浓度和滞后时间相比无显著性差异.同时生物等效性相比也无显著性差异,可认为两种制剂具有生物等效性.结论:国产与进口加替沙星胶囊试验制剂或参比制剂在健康志愿者体内具有生物等效性和类似的药代动力学.

  17. Search and Recommendation

    DEFF Research Database (Denmark)

    Bogers, Toine

    2014-01-01

    -scale application by companies like Amazon, Facebook, and Netflix. But are search and recommendation really two different fields of research that address different problems with different sets of algorithms in papers published at distinct conferences? In my talk, I want to argue that search and recommendation...

  18. Nuclear Security Recommendations on Radioactive Material and Associated Facilities: Recommendations

    International Nuclear Information System (INIS)

    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.

  19. Haloperidol dose when used as active comparator in randomized controlled trials with atypical antipsychotics in schizophrenia : Comparison with officially recommended doses

    NARCIS (Netherlands)

    Hugenholtz, Gerard W. K.; Heerdink, Eibert R.; Stolker, Joost J.; Meijer, Welmoed E. E.; Egberts, Antoine C. G.; Nolen, Willem A.

    2006-01-01

    Objective: To determine the doses of haloperidol as a comparator drug in randomized controlled trials (RCTs) with atypical antipsychotics in patients with schizophrenia and to compare these doses with the officially recommended doses for haloperidol in the United States and the United Kingdom. Data

  20. Haloperidol dose when used as active comparator in randomized controlled trials with atypical antipsychotics in schizophrenia: Comparison with officially recommended doses

    NARCIS (Netherlands)

    Hugenholtz, Greg; Heerdink, E.R.; Stolker, J.J.; Meijer, W.E.E.; Egberts, A.C.G.; Nolen, W.A.

    2006-01-01

    Objective: To determine the doses of haloperidol as a comparator drug in randomized controlled trials (RCTs) with atypical antipsychotics in patients with schizophrenia and to compare these doses with the officially recommended doses for haloperidol in the United States and the United Kingdom. Data

  1. 77 FR 16842 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-03-22

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 3777). This notice announces draft product-specific recommendations, either new or revised, that... Nitrate (multiple RLDs), P Pimecrolimus, Procarbazine, Propylthiouracil, S Sumatriptan, T...

  2. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ... Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Availability AGENCY: Food... Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.'' This guidance provides recommendations to... Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.'' The guidance is applicable...

  3. 77 FR 3777 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-01-25

    ... (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30386), FDA announced the availability of a draft... FR 62793). This notice announces draft product- specific recommendations, either new or revised, that... RLDs) Mifepristone Milnacipran HCl Minocycline HCl Minoxidil (multiple RLDs) Mirtazapine...

  4. 77 FR 74669 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-12-17

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 56851). This notice announces draft product-specific recommendations, either new or revised, that... Risedronate sodium T Tacrolimus Thalidomide Tinidazole For a complete history of previously published...

  5. Using social ties in group recommendation

    OpenAIRE

    Bourke, Steven; McCarthy, Kevin; Smyth, Barry

    2011-01-01

    The social web is a mass of activity, petabytes of data are generated yearly. The social web has proven to be a great resource for new recommender system techniques and ideas. However it would appear that typically these techniques are not so social, as they only generate recommendations for a user acting alone. In this paper we take the social graph data and preference content (via Facebook) of 94 user study participants and generate social group recommendations for them and their friends. W...

  6. Management recommendations: Bear River

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This document is a review of land management practices at the Bear River Migratory Bird Refuge, by a land use specialist. Recommendations, time frame and additional...

  7. Management recommendations: Kirwin Refuge

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This document is a review of land management practices at the Kirwin National Wildlife Refuge, by a land use specialist. Recommendations, time frame and additional...

  8. Management recommendations: Tewaukon Complex

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This document is a review of land management practices at the Tewaukon Complex, by a land use specialist. Recommendations, time frame and additional comments are...

  9. Probabilistic approaches to recommendations

    CERN Document Server

    Barbieri, Nicola; Ritacco, Ettore

    2014-01-01

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

  10. Determination of lercanidipine in human plasma by an improved UPLC–MS/MS method for a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Darshan V. Chaudhary

    2016-04-01

    Full Text Available An improved and reliable ultra-performance liquid chromatography/tandem mass spectrometry (UPLC–MS/MS method has been developed and validated for the determination of lercanidipine in human plasma. Plasma samples with lercanidipine-d3 as an internal standard (IS were prepared by solid phase extraction on Phenomenex Strata-X cartridges using 100 µL of human plasma. Chromatographic analysis was performed on UPLC BEH C18 (50 mm×2.1 mm, 1.7 µm column under isocratic conditions. Linear calibration curves were obtained over a wide dynamic concentration range of 0.010–20.0 ng/mL. Matrix effect was assessed by post-column infusion, post-extraction spiking and standard-line slope methods. The mean extraction recovery was >94% for the analyte and IS. Inter-batch and intra-batch precision (% CV across five quality controls was <5.8%. Bioequivalence study was performed with 36 healthy subjects after oral administration of 10 mg of lercanidipine and the assay reproducibility was evaluated by reanalysis of 133 incurred samples.

  11. Determination of lercanidipine in human plasma by an improved UPLC-MS/MS method for a bioequivalence study$

    Institute of Scientific and Technical Information of China (English)

    Darshan V. Chaudhary; Daxesh P. Patel; Priyanka A. Shah; Jaivik V. Shah; Mallika Sanyal; Pranav S. Shrivastav

    2016-01-01

    An improved and reliable ultra-performance liquid chromatography/tandem mass spectrometry (UPLC–MS/MS) method has been developed and validated for the determination of lercanidipine in human plasma. Plasma samples with lercanidipine-d3 as an internal standard (IS) were prepared by solid phase extraction on Phenomenex Strata-X cartridges using 100 mL of human plasma. Chromatographic analysis was performed on UPLC BEH C18 (50 mm ? 2.1 mm, 1.7 mm) column under isocratic conditions. Linear calibration curves were obtained over a wide dynamic concentration range of 0.010–20.0 ng/mL. Matrix effect was assessed by post-column infusion, post-extraction spiking and standard-line slope methods. The mean extraction recovery was 4 94%for the analyte and IS. Inter-batch and intra-batch precision (%CV) across five quality controls was o 5.8%. Bioequivalence study was performed with 36 healthy sub-jects after oral administration of 10 mg of lercanidipine and the assay reproducibility was evaluated by reanalysis of 133 incurred samples.

  12. A Sensitive Liquid Chromatographic Method for the Analysis of Clarithromycin with Pre-Column Derivatization: Application to a Bioequivalence Study

    Directory of Open Access Journals (Sweden)

    Amir Farshchi

    2009-03-01

    Full Text Available Objective(sA sensitive liquid chromatographic method for the analysis of clarithromycin- a macrolide antibiotic- in human serum, using pre-column derivatization with 9-fluorenylmethyl chloroformate (FMOC-Cl is described. Materials and MethodsThe method involved liquid–liquid extraction of the drug and an internal standard (amantadine followed by pre-column derivatization of the analytes with FMOC-Cl. A mixture of 0.05 M phosphate buffer containing triethylamine (2 ml/l; pH 3.8 and methanol (17:83, v/v was used as mobile phase and chromatographic separation was achieved on a Shimpack CLC-ODS column. The eluate was monitored by a fluorescence detector with respective excitation and emission wavelengths of 265 and 315 nm. ResultsThe analytical method was linear over the concentration range of 0.025-10 μg/ml of clarithromycin in human serum with a limit of quantification of 0.025 μg/ml. The assay is sensitive enough to measure drug levels obtained in human single dose studies.ConclusionIn the present method, sensitivity and the running time of analysis have been improved and successfully applied in a bioequivalence study of three different clarithromycin preparations in 12 healthy volunteers.

  13. 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.

  14. Kernel based collaborative recommender system for -purchasing

    Indian Academy of Sciences (India)

    M K Kavitha Devi; P Venkatesh

    2010-10-01

    Recommender system a new marketing strategy plays an important role particularly in an electronic commerce environment. Among the various recommender systems, collaborative recommender system (CRS) is widely used in a number of different applications such as recommending web pages, movies, tapes and items. CRS suffers from scalability, sparsity, and cold start problems. An intelligent integrated recommendation approach using radial basis function network (RBFN) and collaborative filtering (CF), based on Cover’s theorem, is proposed in order to overcome the traditional problems of CRS. The proposed system predicts the trend by considering both likes and dislikes of the active user. The empirical evaluation results reveal that the proposed approach is more effective than other existing approaches in terms of accuracy and relevance measure of recommendations.

  15. Distributed Deliberative Recommender Systems

    Science.gov (United States)

    Recio-García, Juan A.; Díaz-Agudo, Belén; González-Sanz, Sergio; Sanchez, Lara Quijano

    Case-Based Reasoning (CBR) is one of most successful applied AI technologies of recent years. Although many CBR systems reason locally on a previous experience base to solve new problems, in this paper we focus on distributed retrieval processes working on a network of collaborating CBR systems. In such systems, each node in a network of CBR agents collaborates, arguments and counterarguments its local results with other nodes to improve the performance of the system's global response. We describe D2ISCO: a framework to design and implement deliberative and collaborative CBR systems that is integrated as a part of jcolibritwo an established framework in the CBR community. We apply D2ISCO to one particular simplified type of CBR systems: recommender systems. We perform a first case study for a collaborative music recommender system and present the results of an experiment of the accuracy of the system results using a fuzzy version of the argumentation system AMAL and a network topology based on a social network. Besides individual recommendation we also discuss how D2ISCO can be used to improve recommendations to groups and we present a second case of study based on the movie recommendation domain with heterogeneous groups according to the group personality composition and a group topology based on a social network.

  16. Quantification of cyproheptadine in human plasma by high-performance liquid chromatography coupled to electrospray tandem mass spectrometry in a bioequivalence study.

    Science.gov (United States)

    Mendes, Gustavo Duarte; Arruda, André; Chen, Lu Shi; de Almeida Magalhães, José Cássio; Alkharfy, Khalid M; De Nucci, Gilberto

    2012-01-01

    A rapid, sensitive and specific method to quantify cyproheptadine in human plasma using amitriptyline as the internal standard (IS) is described. The analyte and the IS were extracted from plasma by liquid-liquid extraction using a diethyl-ether/dichloromethane (70/30; v/v) solvent. After removing and drying the organic phase, the extracts were reconstituted with a fixed volume of acetonitrile/water (50/50 v/v)+0.1% of acetic acid. The extracts were analyzed by high performance liquid chromatography coupled to electrospray tandem mass spectrometry (LC-MS/MS). Chromatography was performed isocratically using an Alltech Prevail C18 5 µm analytical column, (150 mm x 4.6 mm I.D.). The method had a chromatographic run time of 4 min and a linear calibration curve ranging from 0.05 to 10 ng/mL (r2 > 0.99). The limit of quantification was 0.05 ng/mL. This HPLC/MS/MS procedure was used to assess the bioequivalence of cyproheptadine in two cyproheptadine + cobamamide (4 mg + 1 mg) tablet formulations (Cobactin® [cyproheptadine + cobamamide] test formulation supplied from Zambon Laboratórios Farmacêuticos Ltda. and Cobavital® from Solvay Farma (standard reference formulation)). A single 4 mg + 1 mg [cyproheptadine + cobamamide] dose of each formulation was administered to healthy volunteers. The study was conducted using an open, randomized, two-period crossover design with a 1-week washout interval. Since the 90% CI for Cmax and AUCs ratios were all within the 80-125% bioequivalence limit proposed by the US Food and Drug Administration, it was concluded that the cyproheptadine test formulation (Cobactin®) is bioequivalent to the Cobavital® formulation for both the rate and the extent of absorption of cyproheptadine.

  17. Implication of enterohepatic re-circulation on single dose bioequivalence evaluation of two brands of clonidine hydrochloride tablets in healthy human volunteers

    Directory of Open Access Journals (Sweden)

    Mehta H

    2009-01-01

    Full Text Available A single dose, crossover bioequivalence study of two different brands of clonidine hydrochloride 25 μg tablets was conducted in 24 (+2 stand by healthy, adult, male, Indian subjects under fasting conditions to check the implication of enterohepatic re-circulation on assessment of bioequivalence. After an overnight fasting of at least 10 h, the subjects received single oral dose of test or reference product with either of the product as per randomization schedule in each period with a washout period of 10 days. The pre-dose blood sample was collected within a period of one h before dosing. The post-dose blood samples were collected at specified time intervals up to 96 h. The plasma concentrations of clonidine were quantified by validated LCMS/MS method and pharmacokinetic parameters were computed. The 90% confidence intervals of test/reference ratios for C max and area under the plasma-concentration- time-curve AUC under 0-t were found to be between 0.80 and 1.25 for log-transformed data. Analysis of variance did not show significant difference to these parameters. No meaningful values of K el and therefore AUC under 0-infinity could be calculated for significant number of subjects due to enterohepatic re-circulation. Based on the results obtained, two different brands of clonidine 25 μg tablets have comparable rate and extent of absorption after oral administration but failed to show bioequivalence as per regulatory requirement of Food and Drugs Administration-united states.

  18. 布洛芬混悬液及其生物等效性研究%Research and Bioequivalence of Ibuprofen Liquid Suspension

    Institute of Scientific and Technical Information of China (English)

    何萍

    2015-01-01

    目的:观察并研究布洛芬混悬液及其生物等效性。方法利用高效液相色谱法,对12名健康男性志愿者交叉单剂量口服布洛芬混悬液及片剂时的血药浓度进行测定,在计算出药物动力学参数及受试制剂的生物利用度的基础上,对两种制剂的生物等效性进行同时评价。结果布洛芬混悬液与片剂的吸收速率、达峰时间、峰浓度差异具有统计学意义(P0.05)。结论布洛芬混悬液与布洛芬片剂具有生物等效性。%ObjectiveTo observe and study Ibuprofen Suspension and its bioequivalence.Methods Using high performance liquid chromatography, the drug concentration in blood of 12 healthy male volunteers a single dose of oral Ibuprofen Suspension and tablets were determined, in the calculation of test preparation and bioavailability based on pharmacokinetic parameters, at the same time to evaluate the bioequivalence of two preparations.Results The absorption rate, Ibuprofen Suspension tablets and statisticaly significant differences in peak time, peak concentration (P0.05). ConclusionIbuprofen Suspension with ibuprofen tablets are bioequivalent.

  19. Summary (and) recommendations

    International Nuclear Information System (INIS)

    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)

  20. Estimating Probabilities in Recommendation Systems

    OpenAIRE

    Sun, Mingxuan; Lebanon, Guy; Kidwell, Paul

    2010-01-01

    Recommendation systems are emerging as an important business application with significant economic impact. Currently popular systems include Amazon's book recommendations, Netflix's movie recommendations, and Pandora's music recommendations. In this paper we address the problem of estimating probabilities associated with recommendation system data using non-parametric kernel smoothing. In our estimation we interpret missing items as randomly censored observations and obtain efficient computat...

  1. In Vitro Studies are Sometimes Better than Conventional Human Pharmacokinetic In Vivo Studies in Assessing Bioequivalence of Immediate-Release Solid Oral Dosage Forms

    OpenAIRE

    Polli, James E.

    2008-01-01

    Human pharmacokinetic in vivo studies are often presumed to serve as the “gold standard” to assess product bioequivalence (BE) of immediate-release (IR) solid oral dosage forms. However, when this general assumption is re-visited, it appears that in vitro studies are sometimes better than in vivo studies in assessing BE of IR solid oral dosage forms. Reasons for in vitro studies to sometimes serve as the better method are that in vitro studies: (a) reduce costs, (b) more directly assess produ...

  2. 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.

  3. 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.

  4. Efficiently Computing Private Recommendations

    NARCIS (Netherlands)

    Erkin, Z.; Beye, M.; Veugen, P.J.M.; Lagendijk, R.L.

    2010-01-01

    Online recommender systems enable personalized service to users. The underlying collaborative filtering techniques operate on privacy sensitive user data, which could be misused if it is leaked or by the service provider him self. To protect user’s privacy, we propose to encrypt the data and generat

  5. Hybrid Personalization for Recommendations

    NARCIS (Netherlands)

    Herder, Eelco; Kärger, Philipp

    2008-01-01

    Herder, E., & Kärger, P. (2008). Hybrid Personalization for Recommendations. In J. Baumeister & M. Atzmüller, Proceedings of the 16th Workshop on Adaptivity and User Modeling in Interactive System, ABIS 2008 (pp. 20-25). October, 6-10, 2008, Würzburg, Germany: Universität Würzburg. Website with link

  6. Towards Geosocial Recommender Systems

    NARCIS (Netherlands)

    Graaff, de Victor; Keulen, van Maurice; By, de Rolf A.

    2012-01-01

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

  7. CETA: Assessment and Recommendations.

    Science.gov (United States)

    National Academy of Sciences - National Research Council, Washington, DC. Committee on Evaluation of Employment and Training Programs.

    This document presents the principal findings and recommendations of a study conducted by the Committee on Evaluation of Employment and Training Program to assess the impact of CETA (Comprehensive Employment and Training Act) on manpower programs. This report is divided into two parts. Part 1 provides an overview of CETA's history, summarizes…

  8. 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...

  9. Privacy in recommender systems

    NARCIS (Netherlands)

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

    2013-01-01

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

  10. The ICRP 2007 recommendations

    Energy Technology Data Exchange (ETDEWEB)

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

    2007-07-01

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

  11. Liquid Chromatography Tandem Mass Spectrometry Method for Quantification of Solifenacin in Human Plasma and its Application to Bioequivalence Study

    Directory of Open Access Journals (Sweden)

    Nishant Paliwal

    2013-06-01

    Full Text Available A hasty, specific and robust assay based on liquid-liquid extraction and liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI MS-MS has been developed and validated for the quantitative analysis of Solifenacin ( a drug used for urinary incontinence in human plasma using Solifenacin D5 as internal standard (ISTD. The precursor to product ion transitions of m/z 363.20/110.10 and m/z 368.14/110.20 were used to measure the analyte and the ISTD, respectively. The method was validated in terms of selectivity, matrix effect, sensitivity, linearity, precision and accuracy, various stabilities (standard stock solution stability in refrigerator and at room temperature, stock dilution stability at refrigerator and room temperature, auto sampler stability, freeze thaw stability, long term stability- 65 o C ± 10o C & long term stability- 22 o C ± 5°C, reagent stability, bench top stability, dry extract stability, wet extract stability in refrigerator, effect of potentially interfering drugs, dilution integrity, recovery, lon suppression through infusion, and blood Stability. The mean percentage recovery of Solifenacin and the internal standard was 65.39 ± 3.646% and 66.24 ± 2.209% respectively. The assay exhibited a linear dynamic range of 0.200 to 30.361 ng mL-1. The RSD % of intra-day and inter-day assay was ≤15%. The application of this assay was demonstrated in a bioequivalence study and will be ideal for clinical pharmacokinetic studies in study population with as lower as 0.200 ng mL-1 analytical sensitivity and as little as 300 μL plasma sample.

  12. Evaluation of a Scenario in Which Estimates of Bioequivalence Are Biased and a Proposed Solution: tlast (Common).

    Science.gov (United States)

    Fisher, Dennis; Kramer, William; Burmeister Getz, Elise

    2016-07-01

    In bioequivalence (BE) testing, it is the convention to identify tlast separately for each concentration-vs-time profile. Within-subject differences in tlast between treatments can arise when assay sensitivity is reached during washout, causing profiles to fall below the limit of quantitation (LOQ) at different sampling times. The resulting tlast difference may be systematic, due to true differences in exposure, and/or random, due to measurement noise. The conventional profile-specific tlast approach assumes that concentrations in the terminal phase are sufficiently low that use of different tlast values between treatments within a subject causes negligible bias in the AUC0-t geometric mean ratio (GMR). Here we investigate the validity of this assumption. Using concentration-vs-time data following oral inhalation of 50 μg salmeterol as an example data set, we conducted simulations to evaluate whether use of different test/reference AUC timeframes arising from a systematic difference in exposure causes sufficient AUC0-t GMR bias to influence the determination of BE. To ensure that results would be relevant to BE testing, we considered only test/reference relative systemic exposures within the BE window (80.00%-125.00%). We show that use of conventional profile-specific tlast exaggerates true differences in systemic exposure; the resulting AUC0-t ratios are biased from true relative exposure by an amount large enough to impact the conclusion of BE. Thus, drugs whose concentrations fall below LOQ during washout may fail BE inappropriately using conventional methods. AUC0-t calculated over a common timeframe within each subject (tlast [common]) minimizes this bias and harmonizes the statistical analysis of BE. PMID:26479406

  13. Cold-start Recommendation Using Bi-clustering and Fusion For Social Recommender Systems

    OpenAIRE

    Zhang, Daqiang; Hsu, Ching-Hsien; Chen, Min; Chen, Quan; Xiong, Naixue; Lloret, Jaime

    2014-01-01

    Social recommender systems leverage collaborative filtering (CF) to serve users with content that is of potential interesting to active users. A wide spectrum of CF schemes has been proposed. However, most of them cannot deal with the cold-start problem that denotes a situation that social media sites fail to draw recommendation for new items, users or both. In addition, they regard that all ratings equally contribute to the social media recommendation. This supposition is against...

  14. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M;

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...... both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials...... and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety...

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

    Directory of Open Access Journals (Sweden)

    Barbara J. Meyer

    2016-02-01

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

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

    Science.gov (United States)

    Meyer, Barbara J

    2016-02-24

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

  17. Rheumatologic rehabilitation: towards recommendations

    Directory of Open Access Journals (Sweden)

    S. Maddali Bongi

    2014-11-01

    Full Text Available Rheumatic patients are highly complex and often affected by chronic diseases. Rehabilitation is generally needed for proper management of the underlying disease. This article describes the characteristics of an effective rheumatologic rehabilitation, takes into account data published in international literature, suggests recommendations based on scientific evidence to develop a correct rehabilitation plan for rheumatic patients and proposes the basis to draw up guidelines in the field of rheumatologic rehabilitation.

  18. Recommendations for FITS Headers

    OpenAIRE

    Hourclé, Joseph

    2012-01-01

    We present an example of best practices for FITS Headers to improve documentation and accessibility of solar physics data distributed as FITS files. We build on existing norms and standards, including ‘Proposed Keywords for SOHO’ and the FITS World Coordinate System (WCS) conventions, and include recommendations on the use of FITS features and extensions to help make data stored and distributed in FITS better suited for both present-day usage and for long-term archiving. O...

  19. Recommending Given Names

    CERN Document Server

    Mitzlaff, Folke

    2013-01-01

    All over the world, future parents are facing the task of finding a suitable given name for their child. This choice is influenced by different factors, such as the social context, language, cultural background and especially personal taste. Although this task is omnipresent, little research has been conducted on the analysis and application of interrelations among given names from a data mining perspective. The present work tackles the problem of recommending given names, by firstly mining for inter-name relatedness in data from the Social Web. Based on these results, the name search engine "Nameling" was built, which attracted more than 35,000 users within less than six months, underpinning the relevance of the underlying recommendation task. The accruing usage data is then used for evaluating different state-of-the-art recommendation systems, as well our new \\NR algorithm which we adopted from our previous work on folksonomies and which yields the best results, considering the trade-off between prediction ...

  20. Badali recommends simplified bills

    International Nuclear Information System (INIS)

    A report on the variety of retail electricity bills across the province, authored by Salvatore Badali of Deloitte Consulting, was recently released by the Ontario Government. The report was commissioned by the Government to examine the underlying reasons for the significant format differences and the wide variation of fixed and variable charges among the approximately 95 local electricity distribution companies across the province. Regarding the appropriateness of the charges the report recommends common definitions for local distribution company (LDC) fixed and variable costs, and consideration of options for reducing LDC charges, mainly by consolidating the sector and sharing such services as customer billing, accounting and out sourcing operations. Seven recommendations deal with bill simplification. These include bills that are clear and easy to read and provide sufficient information for consumers to verify charges; promote energy conservation, e.g. by including historical information; allow comparisons between retail suppliers and distributors; accommodate revenue collection, marketing needs and other billing services. The report also recommends clearly defined and consistently used terminology for standardized line items, suggests ways to provide consumer information in a form useful for making energy conservation decisions, development of an LDC scorecard to enable stake holders to compare their own LDCs with LDCs around the province, creation of a conservation and bill calculation website, consideration of further use of shared services, and solutions to address the removal of line losses from invoices

  1. 基于学习者行为特征的MOOCs学习伙伴推荐%Learners’Activities Based Study Buddies Recommendation Towards MOOCs

    Institute of Scientific and Technical Information of China (English)

    徐彬; 杨丹; 张昱; 李封; 高克宁

    2015-01-01

    大规模开放在线课堂的兴起给高等教育的全球化提供了契机。与大规模参与用户形成鲜明对比的是,目前课程普遍存在完成率不足的问题。造成学生退出的原因之一是学习者缺乏合适的学习伙伴相互交流以及时解决学习中遇到的问题。分析了开放课程中论坛用户的身份特征和学生用户在论坛讨论过程中的行为模式,建立了学习者行为特征模型和学生在讨论过程中形成的关系网络。根据课程内容建立关键词词典,并以此为主题词,提出了一种具有固定主题词的主题模型,进而推断关系网络潜在的主题分布,最终根据主题分布结果为学习者推荐学习伙伴。通过分析Coursera课程平台的真实数据,证明了该学习伙伴推荐方法能有效地挖掘出主题相关的学习者,为学习者相互推荐学习伙伴,在一定程度上将有助于提高学习者的积极性。%The rapid deployment of massive open online courses (MOOCs) has created a surge in the global connec-tivity among students for educational purposes. With contrast to large scale enrolled students, almost all the courses in MOOCs have a low completion rate. One of the important reasons for those who drop out the course is lack of suitable study buddies to communicate each other. This paper analyzes students’posted messages and their roles and behaviors in MOOCs discussion forum, and builds students’behavior feature model and relational networks between students. To estimate student’s relevancy with respected to topic words dictionary which is selected according to course content in advance, this paper proposes a new topic model with fixed topic dictionary, and finally recom-mends study buddies for student by inferred topic distribution. Experiments on crawled Coursera dataset demon-strate that the topic model can find out those students with more similarity on same topic words, and recommend study buddies. And

  2. Estimating Probabilities in Recommendation Systems

    CERN Document Server

    Sun, Mingxuan; Kidwell, Paul

    2010-01-01

    Recommendation systems are emerging as an important business application with significant economic impact. Currently popular systems include Amazon's book recommendations, Netflix's movie recommendations, and Pandora's music recommendations. In this paper we address the problem of estimating probabilities associated with recommendation system data using non-parametric kernel smoothing. In our estimation we interpret missing items as randomly censored observations and obtain efficient computation schemes using combinatorial properties of generating functions. We demonstrate our approach with several case studies involving real world movie recommendation data. The results are comparable with state-of-the-art techniques while also providing probabilistic preference estimates outside the scope of traditional recommender systems.

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

    Science.gov (United States)

    Rutledge, Teresa F., Ed.

    2011-01-01

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

  4. 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...

  5. Personalized professional content recommendation

    Science.gov (United States)

    Xu, Songhua

    2015-10-27

    A personalized content recommendation system includes a client interface configured to automatically monitor a user's information data stream transmitted on the Internet. A hybrid contextual behavioral and collaborative personal interest inference engine resident to a non-transient media generates automatic predictions about the interests of individual users of the system. A database server retains the user's personal interest profile based on a plurality of monitored information. The system also includes a server programmed to filter items in an incoming information stream with the personal interest profile and is further programmed to identify only those items of the incoming information stream that substantially match the personal interest profile.

  6. Collective knowledge: using a consensus conference approach to develop recommendations for physical activity and nutrition programs for persons with type 2 diabetes

    OpenAIRE

    Tanya eBerry; Catherine eChan; Bell, Rhonda C.; Jessica eWalker

    2012-01-01

    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 i...

  7. Cefotetan, a new cephamycin: comparison of in vitro antimicrobial activity with other cephems, beta-lactamase stability, and preliminary recommendations for disk diffusion testing.

    OpenAIRE

    Ayers, L W; Jones, R N; Barry, A. L.; Thornsberry, C; Fuchs, P C; Gavan, T L; Gerlach, E H; Sommers, H M

    1982-01-01

    Cefotetan is a new, potent, 7 alpha-methoxy cephalosporin (cephamycin). The in vitro activity of cefotetan tested in a multiphasic, collaborative study against 12,260 consecutive clinical isolates and 448 selected isolates showed 93% of Enterobacteriaceae, 90% of methicillin-susceptible Staphylococcus aureus (broth dilution), 83% of Bacteroides fragilis, and 72% of non-enterococcal streptococci to be inhibited by less than or equal to 8 micrograms/ml. Beta-Lactamase-producing and -nonproducin...

  8. Ebola virus: recommendations

    CERN Multimedia

    CERN Medical Service

    2014-01-01

    The CERN Medical Service has been closely following, in particular via the WHO, the development of the Ebola virus outbreak currently affecting some African countries. This infectious disease may be passed on through direct contact with the bodily fluids of a sick person.   Based on the recommendations of the WHO and the two Host States, Switzerland and France, as updated on their respective websites, so far there has been no ban on travel to the countries concerned. However, unless it is absolutely essential, you are advised not to visit any of the countries affected by Ebola (Guinea, Republic of Sierra Leone, Liberia, Nigeria). The two Host States have established an alert system, and a check is carried out on departure from the airports of those countries. It is strongly recommended that you contact the Medical Service if you are travelling to those countries. We remind you to observe the basic rules of hygiene such as frequent hand washing, whatever your destination. The Medical Service is...

  9. Maximizing profit using recommender systems

    CERN Document Server

    Das, Aparna; Ricketts, Daniel

    2009-01-01

    Traditional recommendation systems make recommendations based solely on the customer's past purchases, product ratings and demographic data without considering the profitability the items being recommended. In this work we study the question of how a vendor can directly incorporate the profitability of items into its recommender so as to maximize its expected profit while still providing accurate recommendations. Our approach uses the output of any traditional recommender system and adjust them according to item profitabilities. Our approach is parameterized so the vendor can control how much the recommendation incorporating profits can deviate from the traditional recommendation. We study our approach under two settings and show that it achieves approximately 22% more profit than traditional recommendations.

  10. Preventing Recommendation Attack in Trust-Based Recommender Systems

    Institute of Scientific and Technical Information of China (English)

    Fu-Guo Zhang

    2011-01-01

    Despite its success,similarity-based collaborative filtering suffers from some limitations,such as scalability,sparsity and recommendation attack.Prior work has shown incorporating trust mechanism into traditional collaborative filtering recommender systems can improve these limitations.We argue that trust-based recommender systems are facing novel recommendation attack which is different from the profile injection attacks in traditional recommender system.To the best of our knowledge,there has not any prior study on recommendation attack in a trust-based recommender system.We analyze the attack problem,and find that "victim" nodes play a significant role in the attack.Furthermore,we propose a data provenance method to trace malicious users and identify the "victim" nodes as distrust users of recommender system.Feasibility study of the defend method is done with the dataset crawled from Epinions website.

  11. Investigation of the bioequivalence of montelukast chewable tablets after a single oral administration using a validated LC-MS/MS method

    Directory of Open Access Journals (Sweden)

    Zaid AN

    2015-09-01

    Full Text Available Abdel Naser Zaid,1 Murad N Abualhasan,1 David G Watson,2 Ayman Mousa,3 Nadia Ghazal,4 Rana Bustami5 1Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine; 2Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK; 3R&D Department, Avalon Pharma (Middle East Pharmaceutical Industries Co. Ltd., Riyadh, Kingdom of Saudi Arabia; 4Naratech Pharmaceutical Consultancy, 5Pharmaceutical Research Unit, Amman, Jordan Background: Montelukast (MT is a leukotriene D4 antagonist. It is an effective and safe medicine for the prophylaxis and treatment of chronic asthma. It is also used to prevent acute exercise-induced bronchoconstriction and as a symptomatic relief of seasonal allergic rhinitis and perennial allergic rhinitis.Objective: The aim of this study was to evaluate the bioequivalence (BE of two drug products: generic MT 5 mg chewable tablets versus the branded drug Singulair® pediatric 5 mg chewable tablets among Mediterranean volunteers.Methods: An open-label, randomized two-period crossover BE design was conducted in 32 healthy male volunteers with a 9-day washout period between doses and under fasting conditions. The drug concentrations in plasma were quantified by using a newly developed and fully validated liquid chromatography tandem mass spectrometry method, and the pharmacokinetic parameters were calculated using a non-compartmental model. The ratio for generic/branded tablets using geometric least squares means was calculated for both the MT products.Results: The relationship between concentration and peak area ratio was found to be linear within the range 6.098–365.855 ng/mL. The correlation coefficient (R2 was always greater than 0.99 during the course of the validation. Statistical comparison of the main pharmacokinetic parameters showed no significant difference between the generic and branded products. The point estimates (ratios of

  12. 2种阿奇霉素片的人体生物等效性研究%Bioequivalence of 2 Kinds of Azihromycin Tablets in Healthy Volunteers

    Institute of Scientific and Technical Information of China (English)

    张亚玲; 何海霞

    2012-01-01

    OBJECTIVE: To compare the bioequivalence of 2 kinds of Azihromycin tablets in healthy volunteers. METHODS: 2 kinds of Azihromycin tablets were administered by randomized crossover way in 18 male volunteers for 2 periods, and the blood concentrations of azihromycin were determined by microbiological assay. The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioequivalence was evaluated. RESULTS: Main pharmacokinetic parameters were as follows: Cmax(1.21±0.56)μg·mL-1 and (1.25 ±0.62)μg·mL-1;tmax(1.94±0.64)h and (2.44± 1.15)h; AUG0~144h(11.33±7.49)μg·h· mL-1 and (11.61 ± 7.15)μg·h·mL-1. The relative bioavailability of test tablets was (97.59 ± 12.72)%. CONCLUSION: Results of variance analysis and Mests suggest that 2 kinds of Azihromycin tablets are bioequivalent.%目的:比较2种阿奇霉素片的人体生物等效性.方法:18名健康男性志愿受试者采用双周期双制剂交叉试验设计,单剂量口服2种阿奇霉素片,用微生物杯碟法测定血药浓度,以3p97计算药动学参数,并进行生物等效性评价.结果:2种阿奇霉素片主要药动学参数分别为:Cmax(1.21±0.56)、(1.25±0.62)μg·mL-1,tmax(1.94±0.64)、(2.44±1.15)h,AUC0~144h(11.33±7.49)、(11.61±7.15)μg·h·mL-1,受试制剂的相对生物利用度为(97.59±12.72)%.结论:经方差分析和双单侧t检验,2种阿奇霉素片具有生物等效性.

  13. Music Search and Recommendation

    Science.gov (United States)

    Brandenburg, Karlheinz; Dittmar, Christian; Gruhne, Matthias; Abeßer, Jakob; Lukashevich, Hanna; Dunker, Peter; Gärtner, Daniel; Wolter, Kay; Grossmann, Holger

    In the last ten years, our ways to listen to music have drastically changed: In earlier times, we went to record stores or had to use low bit-rate audio coding to get some music and to store it on PCs. Nowadays, millions of songs are within reach via on-line distributors. Some music lovers already got terabytes of music on their hard disc. Users are now no longer desparate to get music, but to select, to find the music they love. A number of technologies has been developed to adress these new requirements. There are techniques to identify music and ways to search for music. Recommendation today is a hot topic as well as organizing music into playlists.

  14. Personalized professional content recommendation

    Energy Technology Data Exchange (ETDEWEB)

    Xu, Songhua

    2015-10-27

    A personalized content recommendation system includes a client interface configured to automatically monitor a user's information data stream transmitted on the Internet. A hybrid contextual behavioral and collaborative personal interest inference engine resident to a non-transient media generates automatic predictions about the interests of individual users of the system. A database server retains the user's personal interest profile based on a plurality of monitored information. The system also includes a server programmed to filter items in an incoming information stream with the personal interest profile and is further programmed to identify only those items of the incoming information stream that substantially match the personal interest profile.

  15. 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...

  16. From micronutrient recommendations to policy

    DEFF Research Database (Denmark)

    Timotijevic, Lada; Raats, Monique M.; Barnett, Julie;

    2010-01-01

    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...

  17. Conclusions and recommendations

    International Nuclear Information System (INIS)

    I - Seismic re-evaluation conclusions: 1. Seismic re-evaluation is not the same as design. The allowable limits and acceptance criteria can go beyond design criteria, provided the safety is not compromised. 2. Displacement based and some non-linear analysis methods are encouraged for seismic reevaluation. 3. Users of experience based methods, such as SQUG, should make sure the data is applicable to their specific case. Implementers of the re-evaluation should have suitable knowledge and experience. They must be trained and qualified to perform the tasks. 4. Test results and post earthquake field investigations are of great importance for seismic reevaluation. They provide much of the information which underlies the processes used. 5. Seismic re-evaluation should make full use of as-built information and data should be verified on site as far as possible. 6. A peer review is strongly recommended as part of seismic re-evaluation. To deliver maximum benefit, it should be concurrent with the re-evaluation. 7. To improve the seismic input from reviewed earthquakes, it is necessary to fully capture the existing uncertainties and these need to be incorporated into the state of the art of the knowledge to characterize the sources, attenuation and site effects. 8. Following re-evaluation, any changes or modifications should take into account safety benefits and potential detriments. II - General recommendations on seismic design and re-evaluation: 1. Human factors, housekeeping and training are important throughout the life of the facility. The seismic safety case needs to be maintained to ensure interaction hazards (eg unlocked cranes, unsecured containers,..) are not introduced between periodic walk-downs and inspections. 2. Pre-earthquake preparations need more attention, particularly the selection and recording of damage indicators which aid post earthquake decision making. A database of information collected from walk-downs (related to the condition of the plant) to

  18. Bioequivalence of glycyrrhizin capsules by HPLC-MS%复方甘草酸苷胶囊的生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    高静; 闫冬; 张煊; 姜春梅

    2011-01-01

    目的 建立人血浆中甘草酸苷的代谢产物--甘草次酸的高效液相色谱-质谱测定法,并评价2种制剂的人体生物等效性.方法 18例男性健康受试者随机分成2组,分别交叉口服复方甘草酸苷胶囊4粒(含甘草酸苷100mg)和复方甘草酸苷片4片(含甘草酸苷100 mg)后,采用HPLC-MS法测定人血浆中甘草次酸的浓度.结果 血浆中甘草次酸的最低定量限为5 ng·mL-1,在5~500 ng·mL-1与峰面积线性关系良好.提取回收率为70.2%~82.2%.受试制剂与参比制剂的各主要药动学参数:t1/2分别为(11.25±3.02)和(11.61±2.55)h,Cmax为(376.0±77.1)和(356.8±69.6)ng·mL-1,tmax为(11.56±2.43)和(10.22士2.98)h,AUC0-t为(5742±1689)和(5882±1645)ng·h·mL-1.结论 本方法灵敏、准确、简便,适用于临床药动学及生物等效性研究;两种制剂具有生物等效性.%Objective To develop an HPLC-MS method for the determination of glycyrrhetic acid in human plasma and to estimate the bioequivalence of glycyrrhetic acid in healthy volunteers. Methods A single oral dose of glycyrrhizin capsules and tablets was given to 18 healthy volunteers in a two-way crossover design to study the bioequivalence. Glycyrrhetic acid concentrations in the plasma were determined by HPLC-MS. Results Calibration curve of glycyrrhetic acid was linear over 5-500 ng · mL-1 , the limit of quantitation for glycyrrhetic acid in the plasma was 5 ng · mL-1 ,and the recovery was 70. 2%-82. 2%. The main pharmacokinetic parameters of the test capsules and reference tablets were as follows. t1/2 was (11.25 ± 3. 02) and (11.61±2. 55) h, Cmax was (376.0±77. 1) and(356. 8 ± 69. 6)ng ·mL-1 , tmax was (11.56±2.43) and (10. 22±2. 98) h, AUC0-t was (5 742±1 689) and (5 882±1 645) ng · h ·mL-1. Conclusion The method is sensitive, accurate, and convenient. It can be applied in the study of pharmacokinetics and bioequivalence of glycyrrhetic acid in humans. The two formulations are bioequivalent.

  19. The significance of pharmacodynamic measurements in the assessment of bioavailability and bioequivalence of psychotropic drugs using CEEG and dynamic brain mapping.

    Science.gov (United States)

    Itil, T M; Itil, K Z

    1986-09-01

    There are a variety of problems in evaluating the bioavailability of psychotropic drugs. Psychotropics have many metabolites; there are discrepancies between peripheral plasma levels and therapeutic effects, and psychotropics must penetrate the blood-brain barrier to have an effect on their target organ. Therefore, "classical" pharmacokinetic evaluation may not be sufficient to determine the bioavailability and bioequivalence of these drugs. Additional and more precise information may be obtained by adding pharmacodynamic procedures to these evaluations. Quantitative pharmaco-EEG (QPEEG), which uses the computer-analyzed electroencephalogram (CEEG), may be the method of choice for determining the pharmacodynamic profiles of psychotropic drugs at the central nervous system (CNS) level. The difficulties in evaluating the bioavailability of psychotropics, as well as the results of several studies that confirm the significance of CEEG as a pharmacodynamic measure, are discussed. PMID:3528132

  20. The significance of pharmacodynamic measurements in the assessment of bioavailability and bioequivalence of psychotropic drugs using CEEG and dynamic brain mapping.

    Science.gov (United States)

    Itil, T M; Itil, K Z

    1986-09-01

    There are a variety of problems in evaluating the bioavailability of psychotropic drugs. Psychotropics have many metabolites; there are discrepancies between peripheral plasma levels and therapeutic effects, and psychotropics must penetrate the blood-brain barrier to have an effect on their target organ. Therefore, "classical" pharmacokinetic evaluation may not be sufficient to determine the bioavailability and bioequivalence of these drugs. Additional and more precise information may be obtained by adding pharmacodynamic procedures to these evaluations. Quantitative pharmaco-EEG (QPEEG), which uses the computer-analyzed electroencephalogram (CEEG), may be the method of choice for determining the pharmacodynamic profiles of psychotropic drugs at the central nervous system (CNS) level. The difficulties in evaluating the bioavailability of psychotropics, as well as the results of several studies that confirm the significance of CEEG as a pharmacodynamic measure, are discussed.

  1. A replicate designed bioequivalence study to compare two fixed-dose combination products of artesunate and amodiaquine in healthy chinese volunteers.

    Science.gov (United States)

    Liu, Yun; Hu, Chaoying; Liu, Gangyi; Jia, Jingying; Yu, Chen; Zhu, Jianmin; Zheng, Qingsi; Zhang, Kanyin E

    2014-10-01

    Artesun-Plus is a fixed-dose combination antimalarial agent containing artesunate and amodiaquine. The current study was conducted to compare the pharmacokinetic and safety profiles of Artesun-Plus and the WHO-designated comparator product Artesunate Amodiaquine Winthrop. To overcome the high intrasubject variability of artesunate, the study applied a two-sequence and four-period crossover (2 by 4), replicate study design to assess bioequivalence between the two products in 31 healthy male Chinese volunteers under fasting conditions. The results showed that the values of the geometric mean ratios of maximum concentration of drug in plasma (Cmax) and area under the concentration-time curve from time zero to the last blood sample collection (AUC0-last) for the artesunate component in the test and reference products were 95.9% and 93.9%, respectively, and that the corresponding 90% confidence intervals were 84.5% to 108.7% and 87.2% to 101.1%, while the geometric mean ratios for the amodiaquine component in the test and reference products were 95.0% and 100.0%, respectively, and the corresponding 90% confidence intervals were 86.7% to 104.1% and 93.5% to 107.0%. In conclusion, bioequivalence between the two artesunate and amodiaquine fixed-dose combination products was demonstrated for both components. The study also confirmed high intrasubject variability, especially for artesunate: the coefficients of variation (CV) of Cmax values for the test and reference products were 39.2% and 43.7%, respectively, while those for amodiaquine were 30.6% and 30.2%, respectively.

  2. Do recommender systems benefit users?

    CERN Document Server

    Yeung, Chi Ho

    2015-01-01

    Recommender systems are present in many web applications to guide our choices. They increase sales and benefit sellers, but whether they benefit customers by providing relevant products is questionable. Here we introduce a model to examine the benefit of recommender systems for users, and found that recommendations from the system can be equivalent to random draws if one relies too strongly on the system. Nevertheless, with sufficient information about user preferences, recommendations become accurate and an abrupt transition to this accurate regime is observed for some algorithms. On the other hand, we found that a high accuracy evaluated by common accuracy metrics does not necessarily correspond to a high real accuracy nor a benefit for users, which serves as an alarm for operators and researchers of recommender systems. We tested our model with a real dataset and observed similar behaviors. Finally, a recommendation approach with improved accuracy is suggested. These results imply that recommender systems ...

  3. Summary and Recommendations

    International Nuclear Information System (INIS)

    The Second CSNI Specialist Meeting on Core Debris-Concrete Interactions was held in Karlsruhe, Germany, on April 1 to 3, 1992. It was hosted by the Kernforschungszentrum Karlsruhe (KfK) and organized in collaboration by OECD-NEA and KfK. About sixty experts attended the meeting, from 13 countries including Russia and the Czech and Slovak Federal Republic and of 2 international organisations. Thirty-seven papers were presented in five sessions on the different aspects of core concrete interaction including melt coolability aspects. The final session summarized the results and discussed the current status of knowledge and the direction of future work. The first CSNI Specialist Meeting on Core Debris-Concrete Interactions had been held at Palo Alto, California in September 1986. Since this meeting, major experimental programs and substantial modelling work had been undertaken worldwide. The scope of the second meeting was to review the experimental and theoretical work and the predictive capabilities for severe accident evaluation. In addition to the scope of the previous meeting the issues of melt spreading and coolability were addressed as options to mitigate or end a severe accident. The contributed papers were presented in the following sessions: I. Experiments on molten core-concrete interactions under predominantly dry conditions II. Modelling and codes of molten core-concrete interactions under predominantly dry conditions III. Experiments on melt spreading and coolability IV. Modelling and codes on melt spreading and coolability V. Code comparisons and plant applications. The following general conclusions and recommendations were formulated after a careful evaluation of the presentations and discussions: 1. A significant integral effects data base on dry molten core debris-concrete interaction now exists which consists of independent experiments in several different facilities, so that no additional large scale experiments under dry conditions are necessary

  4. [Recommendations for neonatal transport].

    Science.gov (United States)

    Moreno Hernando, J; Thió Lluch, M; Salguero García, E; Rite Gracia, S; Fernández Lorenzo, J R; Echaniz Urcelay, I; Botet Mussons, F; Herranz Carrillo, G; Sánchez Luna, M

    2013-08-01

    During pregnancy, it is not always possible to identify maternal or foetal risk factors. Infants requiring specialised medical care are not always born in centres providing intensive care and will need to be transferred to a referral centre where intensive care can be provided. Therefore Neonatal Transport needs to be considered as part of the organisation of perinatal health care. The aim of Neonatal Transport is to transfer a newborn infant requiring intensive care to a centre where specialised resources and experience can be provided for the appropriate assessment and continuing treatment of a sick newborn infant. Intrauterine transfer is the ideal mode of transport when the birth of an infant with risk factors is diagnosed. Unfortunately, not all problems can be detected in advance with enough time to safely transfer a pregnant woman. Around 30- 50% of risk factors will be diagnosed during labour or soon after birth. Therefore, it is important to have the knowledge and resources to resuscitate and stabilise a newborn infant, as well as a specialised neonatal transport system. With this specialised transport it is possible to transfer newly born infants with the same level of care that they would receive if they had been born in a referral hospital, without increasing their risks or affecting the wellbeing of the newborn. The Standards Committee of the Spanish Society of Neonatology reviewed and updated recommendations for intrauterine transport and indications for neonatal transfer. They also reviewed organisational and logistic factors involved with performing neonatal transport. The Committee review included the type of personnel who should be involved; communication between referral and receiving hospitals; documentation; mode of transport; equipment to stabilise newly born infants; management during transfer, and admission at the referral hospital.

  5. SYNTHETIC SLING FAILURE - EVALUATIONS & RECOMMENDATIONS

    Energy Technology Data Exchange (ETDEWEB)

    MACKEY TC; HENDERSON CS

    2009-10-26

    The information and evaluations provided in this report were compiled to address the recurring problem of synthetic sling failure. As safety is the number one priority in all work aspects, a solution must be devised to prevent accidents from occurring. A total of thirteen cases regarding synthetic sling failure were evaluated in order to determine their causes, effects, and preventative measures. From the collected data, it was found that all cases in which the synthetic sling contacted the edge of its load resulted in sling failure. It is required that adequate synthetic sling protection devices be used to protect slings in any lift where the sling comes in direct contact with the edge or corner of its load. However, there are no consensus codes or standards stating the type, material, or purpose of the type of protective device used to protect the sling from being cut. Numerous industry standards and codes provide vague descriptions on how to protect synthetic slings. Without a clear, concise statement of how to protect synthetic slings, it is common for inadequate materials and sling protection devices to be used in an attempt to meet the intent of these requirements. The use of an inadequate sling protection device is the main cause of synthetic sling failure in all researched cases. Commercial sling protection devices come in many shapes and sizes, and have a variety of names, as well as advertised uses. 'Abrasion pads' and 'wear protectors' are two different names for products with the same intended purpose. There is no distinguishable way to determine the extent of sling protection which these devices will provide, or what specific scenarios they are made for. This creates room for error in a field where error is unacceptable. This report provides a recommended action for hoisting and rigging activities which require synthetic slings to contact a load, as well as recommended changes to industry standards which will benefit overall

  6. Economic assessment of nutritional recommendations.

    Science.gov (United States)

    Irz, Xavier; Leroy, Pascal; Réquillart, Vincent; Soler, Louis-Georges

    2015-01-01

    The effect of consumers' compliance with nutritional recommendations is uncertain because of potentially complex substitutions. To lift this uncertainty, we adapt a model of consumer behaviour under rationing to the case of linear nutritional constraints. Dietary adjustments are derived from information on consumer preferences, consumption levels, and nutritional contents of foods. A calibration exercise simulates, for different income groups, how the French diet would respond to various nutrition recommendations, and those behavioural adjustments are translated into health outcomes through the DIETRON epidemiological model. This allows for the ex-ante comparison of the efficiency, equity and health effects of ten nutritional recommendations. Although most recommendations impose significant taste costs on consumers, they are highly cost-effective, with the recommendations targeting salt, saturated fat, and fruits and vegetables (F&V) ranking highest in terms of efficiency. Most recommendations are also economically progressive, with the exception of that targeting F&V.

  7. Recommender systems in industrial contexts

    CERN Document Server

    Meyer, Frank

    2012-01-01

    This thesis consists of four parts: - An analysis of the core functions and the prerequisites for recommender systems in an industrial context: we identify four core functions for recommendation systems: Help do Decide, Help to Compare, Help to Explore, Help to Discover. The implementation of these functions has implications for the choices at the heart of algorithmic recommender systems. - A state of the art, which deals with the main techniques used in automated recommendation system: the two most commonly used algorithmic methods, the K-Nearest-Neighbor methods (KNN) and the fast factorization methods are detailed. The state of the art presents also purely content-based methods, hybridization techniques, and the classical performance metrics used to evaluate the recommender systems. This state of the art then gives an overview of several systems, both from academia and industry (Amazon, Google ...). - An analysis of the performances and implications of a recommendation system developed during this thesis: ...

  8. 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...

  9. Feature Analysis of Recommender Techniques Employed in the Recommendation Engines

    Directory of Open Access Journals (Sweden)

    Gopinath Ganapathy

    2010-01-01

    Full Text Available Problem statement: Recommender Systems (RS have become a widely researched area as it is extensively used in web usage mining and E-commerce platforms. Approach: There were a number of recommender systems available to suggest the web pages for the web users. Results: A recommender system acted as an intelligent intermediary that automatically generates and predicts information and web pages, which suit the users’ behavior and users’ needs. Conclusion: The various recommender models and analyzing the key features of those models and analyzing the features of portal sites that employ recommender systems to help the research community are the key features of this study and survey.

  10. 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. PMID:27046182

  11. Context-Aware Recommender Systems

    Science.gov (United States)

    Adomavicius, Gediminas; Tuzhilin, Alexander

    The importance of contextual information has been recognized by researchers and practitioners in many disciplines, including e-commerce personalization, information retrieval, ubiquitous and mobile computing, data mining, marketing, and management. While a substantial amount of research has already been performed in the area of recommender systems, most existing approaches focus on recommending the most relevant items to users without taking into account any additional contextual information, such as time, location, or the company of other people (e.g., for watching movies or dining out). In this chapter we argue that relevant contextual information does matter in recommender systems and that it is important to take this information into account when providing recommendations. We discuss the general notion of context and how it can be modeled in recommender systems. Furthermore, we introduce three different algorithmic paradigms - contextual prefiltering, post-filtering, and modeling - for incorporating contextual information into the recommendation process, discuss the possibilities of combining several contextaware recommendation techniques into a single unifying approach, and provide a case study of one such combined approach. Finally, we present additional capabilities for context-aware recommenders and discuss important and promising directions for future research.

  12. [Recommendations for waste management].

    Science.gov (United States)

    Vinner, E; Odou, M F; Fovet, B; Ghnassia, J C

    2013-06-01

    Laboratory waste management must ensure the safety of patients and staff, limiting the environmental impacts and control waste disposal budget. Sorting of waste must be carried out at the source. The packaging must be adapted, allowing easy identification of specific disposal routes. With regard to wastes for human or animal health care and/or related research (DASRI), packages must comply with the regulations, standards and ADR if necessary. Storage provisions differ according to the amount of DASRI produced. Waste collection is carried out directly on the place of activity by a certified service provider. Non pre-treated DASRI is incinerated in specific approved plants for a T ° > 1,200 °C. Special provisions also exist for chemical waste and radioactive waste, the latter being regulated by ANDRA. PMID:23765028

  13. Efectos del envejecimiento en las capacidades físicas: implicaciones en las recomendaciones de ejercicio físico en personas mayores. (Effects of aging on physical fitness: implications in the recommendations of physical activity for older adults.

    Directory of Open Access Journals (Sweden)

    Ana Carbonell Baeza

    2009-10-01

    showed to be an useful tool for decelerating the aging process; however, benefits only occur when the physical activity is practiced at the appropriate volume and intensity. Different recommendations for frequency, intensity and duration of physical exercise have been published. The current recommendations for elderly people, determine the minimal criteria for volume and intensity, and they must be taken into consideration when prescribing physical exercise in old people.

  14. Promoting cold-start items in recommender systems

    CERN Document Server

    Liu, Jin-Hu; Zhang, Zi-Ke; Yang, Zimo; Liu, Chuang; Li, Wei-Min

    2014-01-01

    As one of 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, so-called the item-based collaborative filtering, we show that to simply push new items to active users is not a good strategy. To our surprise, 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 ...

  15. 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

  16. 盐酸利托君片在中国健康人体的生物等效性%Bioequivalence of ritodrine hydrochloride tablets in Chinese healthy volunteers

    Institute of Scientific and Technical Information of China (English)

    张佳丽; 吴华; 潘世芬; 王鹤尧

    2012-01-01

    目的 评价2种国产盐酸利托君片在中国健康人体的生物等效性.方法 22名健康女性受试者随机交叉单剂量口服盐酸利托君片试验药物或对照药物,各10 mg.用高效液相色谱-串联质谱法测定血浆中盐酸利托君浓度;用DAS2.0软件计算药代动力学参数,并对2种药物进行生物等效性评价.结果 试验药物和对照药物的主要药代动力学参数:Cmax分别为(5.71±1.83)和(5.61±2.03)ng·mL-1;Tmax分别为(0.54±0.45)和(0.46 ±0.24) h;t1/2分别为(3.64±3.99)和(4.25±4.02)h;AUC0-t分别为(12.31±5.20)和(12.01±5.42)h·ng·mL-1.AUC0-t、AUC0-∞、Cmax的90%可信区间分别为95.8%~111.6%、92.3% ~ 118.9%和95.4% ~ 108.2%.试验药物相对于对照药物的生物利用度F为(105.3±19.96)%.结论 试验药物和对照药物生物等效.%Objective To evaluate the bioequivalence of two preparations of ritodrine hydrochloride tablets. Methods A single oral dose of 10 mg test and reference ritodrine hydrochloride tablets were given to 22 female healthy volunteers in a randomized crossover study. The concentrations of ritodrine hydrochloride were determined by HPLC - MS /MS method. The pharmacokinetic paramters and relative bioavailability were calculated by DAS 2. 0 software, then the bioequivalence was judged. Results The main pharmacokinetic parameters of two preparations were as follows; CmaXwere (5.71 ±1.83), (5.61 ±2.03) ng · mL-1, Tmax were (0. 54 ±0. 45), (0. 46 ±0. 24) h, t1/2were(3. 64 ±3. 99), (4. 25 ±4.02) h, AUC0_t were(12. 31 ±5.20), (12.01 ±5.42) h · ng · mL -1, respectively. The relative bioavailability of test tablets was (105. 3 ± 19. 96) % . The 90% Cis for the ratios of AUC0_t, Cmax were 95. 8% - 111. 6% , 95.4% - 108. 2% , respectively. Conclusion The results demonstrated that the two preparations were bioequivalent.

  17. 尼美舒利颗粒在健康人体的生物等效性%Bioequivalence of Nimesulide Granules in Healthy Volunteers

    Institute of Scientific and Technical Information of China (English)

    曾东向; 李坤艳; 符一岚

    2014-01-01

    目的:评价2种国产尼美舒利颗粒在中国健康人体的生物等效性。方法:18名健康男性受试者随机交叉单剂量口服试验制药或参比制剂各200 mg。用高效液相色谱法测定血浆中尼美舒利的浓度;用DAS2.1软件计算主要药动学参数,并对2种药物进行生物等效性评价。结果:试验制药和参比制剂的主要药动学参数:Cmax分别为(9.28±2.05)和(9.41±2.31)μg·ml-1;Tmax分别为(3.50±1.86)和(3.56±1.65)h; T1/2分别为(3.43±0.85)和(3.38±0.68)h;AUC0-24分别为(77.78±18.42)和(81.69±23.50)μg·ml·h-1;AUC(0-∞)分别为(79.07±19.21)和(82.92±24.11)μg·ml·h-1。 ln(AUC0-24)、ln (AUC0-∞)、ln(Cmax)的90%可信区间分别为90.7%~107.9%、90.6%~111.2%和90.7%~103.0%。试验制药相对于参比制剂的生物利用度F为(96.7±37.6)%。结论:受试制剂和参比制剂生物等效。%Objective:To evaluate the bioequivalence of two kinds of domestic nimesulide granules in healthy volunteers. Meth-ods:In self-control and two-way crossover design, 18 healthy male volunteers were divided into two groups randomly. Each subject was given 100 mg test or reference nimesulide granules with single dose. The concentration of nimesulide in plasma was determined by HPLC. The concentration of nimesulide in plasma was calculated and compared statistically to evaluate the bioequivalence between the two kinds of granules by DAS 2. 1 software. Results:The main pharmacokinetic parameters of test and reference preparations were as follows:Cmax was(9. 28 ± 2. 05) and(9. 41 ± 2. 31)μg·ml-1;Tmax was(3. 50 ± 1. 86)and(3. 56 ± 1. 65)h;T1/2 was (3. 43 ± 0. 85) and(3.38 ±0.68)h;AUC0-24 was(77.78 ±18.42)and(81.69 ±23.50)μg·ml·h-1;AUC(0-∞) was (79.07 ±19.21)and(82.92 ± 24. 11)μg·ml·h-1, respectively. The 90% confidential interval of ln(AUC0-24), ln(AUC0-∞) and ln(Cmax) of the test preparation was 90. 7%-107. 9%,90. 6%-111. 2% and 90. 7%-103. 0%, respectively. The

  18. Bioequivalence of 2 Kinds of Entecavir Preparations in Healthy Volunteers%2种恩替卡韦制剂的人体生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    林琳; 马忠英; 乔逸; 杨林; 杭太俊; 文爱东

    2011-01-01

    OBJECTIVE: To study the bioequivalence of 2 kinds of entecavir preparations in human bodies. METHODS: A total of 20 healthy male volunteers were enrolled in a randomized crossover study in which the subjects were randomly assigned to receive single dose of 0.5 mg Entecavir capsule (test preparation) or Entecavir tablet (reference preparation). The plasma concentrations of entecavir were determined by LC-MS, and the pharmacokinetic parameters and bioavailability were calculated with DAS 2.1.1 program. RESULTS: Main pharmacokinetic parameters of test preparation and reference preparation were as follows: cmax (4.21 ± 1.26) ng·mL-1 vs.(4.06 ± 0.80)ng·m L-1,tmax(0.6 ± 0.4)h vs.(0.6 ± 0.2)h,t1/2β(29.97 ± 4.24)h vs.(36.36 ± 9.14)h, AUC0~96h (10.84 ±1.80) ng·h·mL-1 vs.(10.50 ± 1.25)ng·h·mL-1,AUC0~∞(11.69 ± 1.88)ng·h·mL-1 vs. (11.82 ± 1.54)ng·h·mL-1. The relative bioavailability of test preparation was (103.7 ± 16.6)% , compared with reference preparation. The 90% confidential intervals (CI) of test preparation in AUC0~96h were among the bioequivalent range as compared with reference preparation. CONCLUSION: 2 kinds of Entecavir preparations are bioequivalent.%目的:研究2种恩替卡韦制剂的人体生物等效性.方法:20名健康男性志愿者随机交叉单剂量空腹口服恩替卡韦胶囊(受试制剂)与恩替卡韦片(参比制剂)0.5 mg后,采用液-质联用法测定人血浆中药物浓度,并用DAS2.1.1软件计算药动学参数和生物利用度.结果:恩替卡韦受试制剂与参比制剂在人体内的主要药动学参数分别为:Cmax(4.21±1.26)、(4.06±0.80)ng·mL-1,tmax(0.6±0.4)、(0.6±0.2)h,t1/2β(29.97±4.24)、(36.36±9.14)h,AUC0~96h( 10.84±1.80)、(10.50±1.25) ng· h· mL-1,AUC0~∞(11.69±1.88)、(11.82±1.54) ng.h·mL-1.受试制剂相对于参比制剂的生物利用度为(103.7±16.6)%.AUC0~96h的90%置信区间在等效范围内.结论:2种恩替卡韦制剂为生物等效制剂.

  19. Bioequivalence of nicotinic acid sustained-release tablets in healthy volunteers%烟酸缓释片在健康人体的生物等效性

    Institute of Scientific and Technical Information of China (English)

    葛苗苗; 卫乐乐; 方凯; 黄露; 黎维勇

    2011-01-01

    目的 研究烟酸缓释片(广谱凋血脂药)在健康人体的药代动力学,并评价其生物等效性.方法 30名男性健康志愿者随机交叉单剂量口服试验制剂或参比制剂1.5 g,用高效液相色谱-串联质谱法测定血浆中烟酸浓度.结果 单剂量口服烟酸试验制剂或参比制剂1.5 g,药代动力学参数如下:AUC0-t分别为(20.05±16.29),(21.61±18.06)μg·h·mL-1;AUC0-∞分别为(20.81±16.30),(22.81±18.47)μg·h·mL-1;Cmax分别为(8.72±6.81),(9.57±8.22)μg·mL-1;tmax分别为(4.41±1.34),(4.31±1.29)h;t1/2分别为(4.00±4.90),(2.91±3.39)h,烟酸缓释片的相对生物利用度为(96.6±30.9)%.结论 受试制剂与参比制剂生物等效.%Objective To study the pharmacokinetics of nicotinic acid sustained-release tablets in healthy volunteers and evaluate the bioequivalence. Methods Single oral dose ( 1.5 g of test and reference formulations) were given to 30 volunteers in an open randomized crossover way.The concentrations of nicotinic acid in plasma were determined by HPLC- MS/MS. The pharmacokinetic parameters were calculated and the bioequivalence of two formulations were evaluated by DAS program.Results The main pharmacokinetic parameters of test and reference preparations obtained from single oral dose were as follows: AUC0-t were (20. 05±16.29),(21.61 ± 18.06) μg · h · mL-1;AUC0-∞ were (20. 81 ± 16. 30 ), ( 22. 81 ± 18.47 ) μg · h · mL - 1; Cmax were ( 8. 72 ±6.81),(9.57 ±8.22) μg · mL-1;tmax were(4.41 ± 1.34), (4.31 ±1.29)h; t1/2 were ( 4. 00 ±4.90),(2.91 ±3.39)h. Conclusion The two preparations were bioequivalent.

  20. 硫酸氢氯吡格雷片的人体生物等效性%The bioequivalence of clopidogrel hydrogen sulfate tablets in Chinese healthy volunteers

    Institute of Scientific and Technical Information of China (English)

    舒成仁; 卫乐乐; 黄露; 黎维勇

    2012-01-01

    OBJECTIVE To study the bioequivalence of clopidogrel hydrogen sulfate tablets. METHODS 30 healthy male volunteers were administered 150 mg clopidogrel hydrogen shlfate tablets orally in a randomized crossover design. The drug concentrations in the plasma samples were determined by an HPLC-MS/MS method. With use of DAS software the pharmaco-kinetic parameters were calculated and the bioequivalence of the two preparations was evaluated. RESULTS The main pharma-cokinetic parameters of the test and reference preparations were as follows;/?, were(0. 98 ± 0. 34) h and(0. 86 ± 0. 36) h;Cmax were(8 994. 7 + 3 515. 6) ng·mL-1 and(9 677. 0±3 838. 1) ng·mL-1 ;t1/t2 were(7. ()± 2. 4) h and(7. 0+1. 8) h; AUG41-24 were (31 670. 1 ± 13 545. 7) ng·h·mL-1 and(32 887. 4 ± 14 907. 5) ng·h·mL-1; AUG were(34 096. 8 + 14 482. 3) ng·h·mL-1 and(35 550. 4+16 455.5) ng·h·mL-1. The relative bioavailability of the test tablet was(97. 7 + 16. 6)%. CONCLUSION The two preparations are bioequivalent.%目的:研究硫酸氢氯吡格雷片受试制剂与参比制剂的人体生物等效性.方法:30名健康男性志愿者随机交叉单剂量口服硫酸氢氯吡格雷试验片或对照片1 50 mg,采用高效液相色谱-串联质谱(HPLC-MS/MS)法测定血浆中氯吡格雷羧酸代谢产物浓度.用DAS软件计算两者的药动学参数,并评价其生物等效性.结果:受试制剂与参比制剂的tmax分别为(0.98±0.34)、(0.86±0.36) h;Cmax分别为(8 994.7±3 515.6)、(9 677.0±3 838.1)ng·mL-1;t1/2分别为(7.0±2.4)、(7.0±1.8)h;AUG0-24分别为(31 670.1±13 545.7)、(32 887.4±14 907.5)ng·h·mL-1;AUG0→∞分别为(34 096.8±14 482.3)、(35 550.4±16 455.5)ng·h·mL-1.受试制剂的相对生物利用度为(97.7±16.6)%.结论:2种制剂具有生物等效性.

  1. Study on Bioequivalence of Rifapentine Capsules in Healthy Volunteers%利福喷汀胶囊人体生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    唐秀玲; 杨静; 冯智军; 李雪晴; 丁莉坤; 宋薇; 贾艳艳; 鹿成韬; 宋颖

    2013-01-01

    Objective: To evaluate the bioequivalence of two kinds of rifapentine capsules in healthy volunteers. Method: A randomized crossover design was performed in 20 healthy male volunteers. A single oral dose of 600mg test preparation or reference preparation was administrated. Plasma concentrations of rifapentine were measured by HPLC. The pharmacokinetic parameters were calculated by DAS software and the bioequivalence was evaluated. Result: After a single oral dose of 600 mg rifapentine test or reference preparation, the main pharmacokinetic parameters were as follows:t1/2 of (16. 44 ±4. 99) and (18. 02 ±4. 76)h;tmax of (5. 6 ± 1. 4) and (6.0±1.4)h;Cmox of (8.41 ±1.71) and (8.96 ± 1.76) μg · ml-1 ;AUC0-72 of (200.41 ±55. 29) and (220. 86 ±62.40) μg · h · ml-1; AUC0-x of (215.58 ±63.51) and (241.06 ±75.09) μg · h · ml-1. The relative bioavailability was (92. 3 ± 14. 3) %.Conclusion: The two rifapentine preparations are bioequivalent.%目的:评价两种利福喷汀胶囊的人体生物等效性.方法:20名男性健康志愿者随机交叉单剂量口服受试制剂或参比制剂利福喷汀胶囊600 mg后,采用高效液相色谱法测定血药浓度,用DAS软件计算药动学参数,并评价其生物等效性.结果:单剂量口服利福喷汀胶囊受试制剂和参比制剂的主要药动学参数分别为:t1/2(16.44 ±4.99)、(18.02±4.76)h;tmax(5.6±1.4)、(6.0±1.4)h; Cmax(8.41 ±1.71)、(8.96±1.76) μg· ml-1;AUC(0~72) (200.41 ±55.29)、(220.86±62.40)μg·h·ml-1;AUC0-∞(215.58±63.51)、(241.06±75.09)μg·h·m1-1.受试制剂的相对生物利用度为(92.3±14.3)%.结论:两种制剂具有生物等效性.

  2. 罗红霉素胶囊人体生物等效性研究%Bioequivalence of Roxithromycin Capsule in Healthy Volunteers

    Institute of Scientific and Technical Information of China (English)

    曾朝英; 秦剑; 周远大; 何海霞; 李娟

    2011-01-01

    目的:探讨试验药罗红霉素胶囊在人体的相对生物等效性.方法:20名健康志愿受试者随机交叉单剂量口服试验药或对照药罗红霉素胶囊300 mg,采用微生物杯碟法测定血清中罗红霉素浓度,用3P97软件计算药动学参数,并评价其生物等效性.结果:试验药与对照药药时曲线符合口服二室模型.主要药动学参数t1/2β 分别为(10.41±6.28)h和(12.50±6.40)h;Cmax分别为(7.19±2.72)μg·mL-1和(7.31±2.38)μg·mL-1;Tmax分别为(2.80±1.21)h和(2.52±0.91)h;AUC0-t分别为(67.72±32.92)μg·h·mL-1和(69.21±31.38)μg·h·mL-1.试验药相对生物利用度为( 97.85±14.19)%.结论:经方差分析和单双侧t检验,试验药罗红霉素胶囊与对照药罗红霉素胶囊具有生物等效性.%Objective: To study the bioequivalence and pharmacokinetics of roxithromycin capsules in 20 healthy male volunteers. Methods: A single dose of 300 mg of roxithromycin capsules were administered to 20 volunteers with a randomized, 2-way crossover design and the serum concentrations of roxithromycin were determined by microbiological assay. The pharmacokinetic parameters were calculated with 3P97 pharmacokinetic program and the bioequivalence was evaluated. Results: The t1/2β, Cmax, Tmax and AUC0-t of two roxithromycin capsules were (10. 41 ±6. 28) hand (12.50 ±6.40) h, (7. 19 ±2.72)μg/mL and (7.31 ±2.38) μg/mL, (2.80 ±1.21) h and (2.52 ±0.91) h, (67.72 ±32.92) μg ? h ? mL-1 and (69.21 ±31.38) μg ? h ? mL-1 , respectively. The relative bioavailability of test capsules were (97.85 ±14.19) %. Conclusions; Both roxithromycin capsules are bioequivalent.

  3. 2种奥卡西平片的人体生物等效性研究%Bioequivalence of 2 Kinds of Oxcarbazepine Tablets in Healthy Volunteers

    Institute of Scientific and Technical Information of China (English)

    李绪春; 徐富培; 周远大

    2012-01-01

    目的:评价国产与进口奥卡西平片剂的生物等效性.方法:18名健康男性受试者自身交叉单剂量口服国产或进口奥卡西平片300 mg,以高效液相色谱-紫外(HPLC-UV)法测定血浆中奥卡西平浓度,用3p97软件计算主要药动学参数,以方差分析与单双侧t检验进行统计分析.结果:2种奥卡西平片剂的血浆中药动学参数分别为:t1/2(15.21±4.04)、(14.51±3.06)h,tmax(5.67±2.45)、(5.17±2.33)h,cmax(0.50±0.13)、(0.56±0.20)μg·mL-1,AUC0~48h(11.59±4.16)、(12.47±4.66)μg·h·mL-1.国产奥卡西平片的相对生物利用度为(94.81±14.21)%.结论:2种片剂在健康人体内具有生物等效性.%OBJECTIVE: To evaluate the bioequivalence of domestic and imported Oxcarbazepine tablets. METHODS: 18 healthy male volunteers were given single oral dose of domestic and imported Oxcarbazepine tablet 300 mg according to a randomized crossover design. Plasma concentration of oxcarbazepine was detected by HPLC-UV. The pharmacokinetic parameters of oxcarbazepine were calculated with 3p97 software. The bioequivalence was calculated by analysis of variance and two one side /-teat. RESULTS: The pharmacokinetic parameters of 2 kinds of Oxcarbazepine tablets were as follows: t1/2{ 15.21 ±4.04)h vs.( 14.51 ± 3.06) h;tmax(5.67±2.45)h vs.(5.17±2.33)h;cmax(0.50±0.13)μg·mL-1 vs .(0.56±0.20)μg·mL-1;AUC0~48h(11.59 ±4.16)μg·h·mL-1 vs. (12.47 ±4.66)μg·h·mL-1, respectively. The relative bioavailability of domestic Oxcarbazepine tablet was (94.81 ± 14.21)%. CONCLUSION : 2 kinds of Oxcarbazepine tablets are bioequivalent in human body.

  4. 美洛昔康胶囊人体生物等效性的研究%Bioequivalence of Meloxicam capsule in healthy volunteers

    Institute of Scientific and Technical Information of China (English)

    黄玉友; 任小群; 宋林; 蒋学华; 何毅; 王凌

    2013-01-01

    目的 评价美洛昔康胶囊(受试制剂)和美洛昔康片(参比制剂)在健康人体的生物等效性.方法 采用HPLC-UV法,测定人血浆中美洛昔康的浓度,并进行方法学验证;采用随机交叉自身前后对照试验设计,20名受试者分别口服受试制剂和参比制剂15 mg后,测定美洛昔康的血药浓度,计算药动学参数,评价两制剂的生物等效性.结果 美洛昔康胶囊和美洛昔康片的t1/2分别为24.61±10.46、26.56±7.57 h,Cmax分别为2.45±0.33、2.49±0.37 μg· mL-1,Tmax分别为4.58±1.35、5.05 ±1.51 h;AUC0→1分别为76.57±17.71、84.12±19.91 μg·h·mL-1.美洛昔康胶囊的相对生物利用度为92.8%±17.7%.结论 两制剂在健康中国人体内具有生物等效性.%OBJECTIVE To study the bioequivalence of Meloxicam capsules (test preparation) and Meloxicam tablets (reference preparation) in Chinese healthy volunteers.METHODS An HPLC-UV assay method for determining the concentration of meloxicam in human plasma was developed and validated.This method was applied to a clinical pharmacokinetic study of meloxicam in 20 healthy subjects using a two-stage,cross over study design.The subjects sequentially received single oral doses of 15 mg of meloxicam (reference or test preparations).During each stage,multiple blood samples were collected and the drug plasma concentrations were measured.The pharmacokinetic parameters i.e.AUC,t1/2 were calculated and utilized to evaluate the bioequivalence between the two preparations.RESULTS The t1/2 for reference and test products were 26.56 ± 7.57 and 24.61 ± 10.46 h,respectively,while the Cmax were 2.49 ± 0.37,2.45 ± 0.33 μg· mL-1 for reference and test preparation,respectively.The Tmax for reference and test products were 5.05 ± 1.51,4.58 ± 1.35 h,respectively,while the A UC0→t were 84.12 ± 19.91,76.57 ± 17.71 μg·h· mL-1 for reference and test preparations,respectively.The relative bioavailability of Meloxicam Capsules is 92.8%

  5. 2种多潘立酮片的人体生物等效性研究%Bioequivalence of Domperidone Tablets in Healthy Volunteers

    Institute of Scientific and Technical Information of China (English)

    马萍; 李鹏飞; 童卫杭; 刘丽宏; 丁春雷; 高文静; 王玲

    2011-01-01

    OBJECTIVE: To study the bioequivalence of Domperidone tablets in healthy volunteers. METHODS: In randomized cross-over design, 22 healthy volunteers were given single oral dose of test preparations 10 mg and reference preparation 10 mg. The plasma concentration of domperidone was determined by LC-MS/MS. The pharmacokinetic parameters were calculated and the bioequivalence was evaluated using BAPP2.0 software. RESULTS: The main pharmacokinetic parameters of test preparations and reference preparations were as follows:tmax(0.55 ± 0.15)h and (0.57 ± 0.11)h; t1/2(10.22 ± 1.29) h and (10.90 ± 1.44)h;cmax (12.721 ±5.567)μg·L-1 and (13.265±5.787)μg·L-1;AUC0-36h(42.550±11.724)mg·h·L-1 and(44.259±8.813)mg·h·L-1;AUC0~36m. (45.539 ± 12.327)mg·h·L-1 and (47.900±9.446)mg·h·L-1. The relative bioavailability was (96.5± 19.2)%. The main pharmacokinetic parameters showed no statistically significant difference between two preparations. CONCLUSION: Test preparations and reference preparations are bioequivalent.%目的:研究2种多潘立酮片在健康人体内的生物等效性.方法:健康志愿者22名,采用随机交叉试验设计,单剂量口服多潘立酮片受试制剂或参比制剂10 mg,应用高效液相色谱串联质谱电喷雾(LC-MS/MS)法测定各受试者给药后不同时间点的血药浓度,计算药动学参数,应用BAPP 2.0软件进行生物等效性评价.结果:受试制剂与参比制剂的药动学参数分别为:tmax(0.55±0.15)、(0.57±0.11)h,t1/2(10.22±1.29)、(10.90±1.44)h,Cmax(12.721±5.567)、(13.265±5.787)μg·L-1,AUC0~36h(42.550±11.724)、(44.259±8.813)mg·h·L-1,AUC0~∞(45.539±12.327)、(47.900±9.446 )mg·h·L-1.多潘立酮片受试制剂相对于参比制剂的生物利用度为(96.5±19.2)%,主要药动学参数经统计学分析无显著性差异.结论:受试制剂与参比制剂具有生物等效性.

  6. Bioequivalence research of Compound glycyrrhizin capsules%复方甘草酸苷胶囊的人体生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    韦凤华; 宋林; 毛棉; 王凌

    2011-01-01

    OBJECTIVE To study the bioavailability and bioequivalence of Compound glycyrrhizin capsules in Chinese healthy volunteers.METHODS A LC - MS method for determining the concentration of glycyrrhetic acid in human plasma was developed and methodological validated.In accordance with randomized two- period self crossover study ,24 volunteers were administered with single oral dose of 75 mg of test preparation or refrence preparation, then the concentration of glycyrrhetic acid in human plasma determined,the pharmacokinetic parameters was calculated and the bioequivalence of the two preparations evaluated.RESULTS After receiving single dose of 75 mg of test preparation or refrence preparation, t1/2 of glycyrrhetic acid were 9.80 ± 1.80,8.96 ± 0.94 h, Cmax were 58.69 ±8.27,60.33 ±6.81 ng·mL-1 ,Tmax were 10.58 ±0.93,10.58 ±0.93 h,AUC0→1 were 723.81 ±55.79,703.23 ±41.55 ng·h.mL- 1, respectively.The relative bioavailability of Compound glycyrrhizin capsules was 103.1% ± 7.2%.CONCLUSION The results showed that the test preparation was bioequivalent with the refrence preparation in the healthy volunteers.%目的 评价复方甘草酸苷胶囊在健康人体中的生物等效性.方法 采用LC-MS法测定人血浆中的甘草次酸;用随机双交叉自身对照试验设计,24名受试者分别口服75 mg受试制剂和参比制剂后,测定甘草酸苷代谢物甘草次酸的血药浓度,计算药物动力学参数,评价两制剂的生物等效性.结果 复方甘草酸苷胶囊和片剂中甘草次酸的t1/2分别为9.80±1.80、8.96±0.94 h,Cmax分别为58.69±8.27、60.33±6.81 ng·mL-1,Tmax分别为10.58±0.93、10.58±0.93 h;AUC0→1分别为723.81±55.79、703.23±41.55 ng·h·mL-1.以AUC0→1计算,复方甘草酸苷胶囊的相对生物利用度为103.1%±7.2%.结论 两制剂在健康人体内具有生物等效性.

  7. 拉米夫定片人体生物等效性评价%Evaluation on bioequivalence of lamivudine tablets in healthy volunteers

    Institute of Scientific and Technical Information of China (English)

    马媛媛; 葛庆华; 丁存刚; 周臻; 李雪宁

    2013-01-01

    目的 评价拉米夫定片在健康人体的生物等效性.方法 健康志愿者22例,随机2×2交叉,单剂量口服受试和参比制剂拉米夫定片100 mg,洗脱期为1周.采用LC-MS/MS法测定血药浓度,并用DAS药动学软件进行参数计算及评价2种制剂的生物等效性.结果 单剂量口服受试和参比制剂后,血浆中拉米夫定的主要药动学参数:ρmax分别为(881.4±236.8)和(985.0±292.4)μg·L-1,tmax分别为(0.989±0.323)和(1.034±0.651)h,t1/2分别为(2.889±0.622)和(2.820±0.368)h,AUC0→t分别为(3 435±627.7)和(3 504±506.7) μg·h·L-,AUC0→∞分别为(3 529±630.9)和(3 592±519.4)tg·h·L-1,受试制剂与参比制剂的人体相对生物利用度(F)是(98.45±13.50)%.结论 拉米夫定片受试制剂与参比制剂具有生物等效性.%AIM To evaluate the bioequivalence of lamivudine tablets in healthy male volunteers. METHODS Twenty-two healthy volunteers in randomized 2×2 crossover study were given a single oral 100 mg dose of test or reference lamivudine tablets. The plasma concentrations were determined by LC-MS/MS, and the pharmacokinetic parameters were calculated and the bioequivalence of two formulations were evaluated by DAS program. RESULTS The main pharmacokinetic parameters for test and reference formulations were as follows: pmax were ( 881.4 ± 236. 8) and (985.0 ± 292.4)μg·L-1,tmaxwere(0.989±0.323)and(1.034±0.651)h,t1/2 were(2.889 ± 0.622)and(2.820 ± 0.368)h, AUC0→t were(3 435±627.7)and(3 504 ± 506.7)μg·h·L-1, AUC0→∞ were(3 529 ± 630.9)and(3 592 ±519.4) μg·h·L-1,respectively.The relative bioavailability of lamivudine was(98.45 ± 13.50)% . CONCLUSION The results show that the two lamivudine tablets made by two different corporations are bioequivalent.

  8. Bioequivalence Study of Paroxetine Hydrochloride Film-Coated Tablets%盐酸帕罗西汀薄膜衣片的生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    施爱明; 王蒙; 周文佳; 张全英

    2012-01-01

    目的 以盐酸帕罗西汀片(赛乐特)为参比制剂,研究盐酸帕罗西汀薄膜衣片的人体相对生物利用度,以判断两种制剂是否具有生物等效性.方法 采用随机、开放、双周期交叉试验设计,24例男性健康受试者禁食过夜后空腹单剂量口服盐酸帕罗西汀制剂20 mg,液相色谱-串联质谱法(LC- MS/MS)测定血浆中帕罗西汀的浓度,应用DAS2.0软件计算有关药动学参数并评价两种制剂的生物等效性.结果 单剂量口服受试制剂和参比制剂的主要药动学参数pmax分别为(5.102±2.955)和(5.396±2.852)μg·L-1;tmax分别为(5.22±1.83)和(5.35±0.78)h;t1/2分别为(11.76±2.91)和(11.98±3.57)h;AUC0~96h分别为(118.1±90.2)和(118.9±86.0)μg·h·L-1,AUC0-∞分别为(120.2±91.0)和(121.5±87.6) μg·h·L-1.结论 受试制剂与参比制剂的人体相对生物利用度为( 100.6±22.0)%,两种制剂具有生物等效性.%OBJECTIVE To evaluate the relative bioavailibility and bioequivalence of paroxetine hydrochloride film-coated tablets. METHODS In a randomized crossover study, 24 healthy Chinese male subjects received a single oral dose (20 mg) of either test or reference paroxetine hydrochloride tablets after an overnight fast The plasma concentrations of paroxetine were determined by a validated LC-MS/MS method. The pharmacokinetic parameters, the relative bioavailability and bioequivalence of two formulations were evaluated by DAS 2. 0 software. RESULTS After a single oral dose of 20 mg test or reference paroxetine tablets, the pharmacokinetic parameters of paroxetine were as follows: ρmax ( 5. 102 ± 2. 955) and ( 5. 396 ± 2. 852 ) μg · L-1; tmax ( 5. 22 ± 1. 83 ) and (5. 35 ± 0.78) h ; t1/2(11.76±2.91) and (11.98 ±3.57) h; AUC0-96h (118. 1 ±90.2) and (118. 9 ± 86. 0) μg · h · L-1; AUC0-8 (120. 2 ±91.0) and ( 121. 5 ±87. 6) μg · h · L-1 , respectively. CONCLUSION The relative bioavailability of the test paroxetine hydrochloride film

  9. 多水平模型在生物等效性评价中的应用(Ⅱ)%Application of multilevel models in the evaluation of bioequivalence (Ⅱ)

    Institute of Scientific and Technical Information of China (English)

    刘巧兰; 沈卓之; 李晓松; 陈峰; 杨珉

    2010-01-01

    The main purpose of this paper is to explore the applicability of multivariate multilevel models for bioequivalence evaluation. Using an example of a 4×4 cross-over test design in evaluating bioequivalence of homemade and imported rosiglitazone maleate tablets,this paper illustrated the multivariate-model-based method for partitioning total variances of In (AUC) and In (C_(max)) in the framework of multilevel models. It examined the feasibility of multivariate multilevel models in directly evaluating average bioequivalence (ABE),population bioequivalence (PBE) and individual bioequivalenc (IBE). Taking into account the correlation between In (AUC) and In (C_(max)) of rosiglitazone maleate tablets,the proposed models suggested no statistical difference between the two effect measures in their ABE bioequivalence via joint tests,whilst a contradictive conclusion was derived based on univariate multilevel models. Furthermore,the PBE and IBE for both In (AUG) and In(C_(max)) of the two types of tablets were assessed with no statistical difference based on estimates of variance components from the proposed models. Multivariate multilevel models could be used to analyze bioequivalence of multiple effect measures simultaneously and they provided a new way of statistical analysis to evaluate bioequivalence.%探讨多变量多水平模型在生物等效性评价中的应用价值.以4×4交叉试验设计的国产和进口罗格列酮药物生物等效性评价为研究实例,研究多变量多水平模型在同时评价多个指标等效性时方差分量的分解方式,并探讨在多变量多水平框架下评价平均、群体和个体等效性评价的可行性.多变量多水平模型考虑了罗格列酮药物指标ln(AUC)和ln(C_(max))的相关性,在两个指标出现一个平均等效而另一个平均不等效的矛盾结果时,通过联合检验最终判断两个指标联合具有平均等效性.根据多变量多水平模型方差分量,进一步获得了国

  10. Recommendations on the Nature and Level of U.S. Participation in the International Thermonuclear Experimental Reactor Extension of the Experimental Reactor Extension of the Engineering Design Activities. Panel Report To Fusion Energy Sciences Advisory Committee (FESAC)

    International Nuclear Information System (INIS)

    The DOE Office of Energy Research chartered through the Fusion Energy Sciences Advisory Committee (FESAC) a panel to 'address the topic of U. S. participation in an ITER construction phase, assuming the ITER Parties decide to proceed with construction.' (Attachment 1: DOE Charge, September 1996). Given that there is expected to be a transition period of three to five years between the conclusion of the Engineering Design Activities (EDA) and the possible construction start, the DOE Office of Energy Research expanded the charge to 'include the U.S. role in an interim period between the EDA and construction.' (Attachment 2: DOE Expanded Charge, May 1997). This panel has heard presentations and received input from a wide cross-section of parties with an interest in the fusion program. The panel concluded it could best fulfill its responsibility under this charge by considering the fusion energy science and technology portion of the U.S. program in its entirety. Accordingly, the panel is making some recommendations for optimum use of the transition period considering the goals of the fusion program and budget pressures.

  11. 上海市18~69岁居民对推荐身体活动量的知晓现状%Awareness to recommended levels of physical activity among residents aged 18-69 years in Shanghai

    Institute of Scientific and Technical Information of China (English)

    李新建; 李光耀; 吕宁; 姜综敏; 姚海宏; 严青华; 徐继英; 仲伟鉴

    2015-01-01

    Objective To understand status of awareness to recommended level of physical activity and provide evi-dences for further promoting participation of physical activity among residents in Shanghai.Methods Stratified random sam-pling method was used to enroll samples in all 18 districts in Shanghai.A total of 8548 participants aged 18 -69 years were re-cruited and questionnaire survey was carried out by face-to-face interview.The unified questionnaire of evaluating national ac-tion for health lifestyle designed by China National Center for Disease Control and Prevention was used.The significances of rates were tested by Chi-square and associations with determinations were analyzed by logistic regression model.Results A-mong the residents in Shanghai,7544 (89.2%)and 3875 (45.8%)participants knew the recommended levels of “at least 6000 steps of physical activity of daily life,travel,and exercising everyday”and “at least 150 minutes of moderate intensity aerobic exercise every week”.Analysis results of logistic regression showed that gender (OR =1.184,95%CI:1.030 -1.361),age (OR =1.136,95% CI:1.020 -1.264),education level (OR =1.143,95% CI:1.046 -1.249),annual household income (OR =1.047,95% CI:1.009 -1.086)and area of residence (OR =0.796,95% CI:0.697 -0.922) for the former and education level (OR =1.241,95% CI:1.174 -1.313)and area of residence (OR =1.473,95% CI:1.345 -1.614)were influencing factors to awareness.Conclusion There was higher proportion of awareness to recommended level of “at least 6000 steps of physical activity of daily life,travel,and exercising everyday”compared with “at least 150 minutes of moderate intensity aerobic exercise every week”among Shanghai residents.After adjustment for age and gender,ed-ucation level and area of residence can influence awareness level of both recommended levels.%目的:了解上海市居民对推荐身体活动量的知晓情况,为进一步促进市民参加身体活动

  12. Bioequivalence of ondansetron hydrochloride tablets in healthy volunteers%盐酸昂丹司琼片在健康人体的生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    李筱旻; 甘露名; 贺秀梅; 陈锋

    2011-01-01

    AIM: To study the bioequivalence of two ondansetron hydrochloride tablets in Chinese healthy volunteers. METHODS: A randomized crossover study designing was adopted in the study. 20 healthy volunteers were given single oral dose of ondansetron (8 mg), The concentration of ondansetron in plasma was measured by HPLC-MS. All statistic analysis was performed by using SPSS 13. 0 statistics software. RESULTS: The pharmacokinetic parameters of the test and reference preparation were as follow: Cmax were (33±8) and (32±8) μg/L,tmax were (1.5 ± 0.3) and (1.5 ± 0.4) h,AUC0~24 were (176 ± 67) and (168 ± 58)μg · h · L-1 , AUC0~∞ were (188±70) and (182 ±63) μg· h · L-1. The relative bioavailability of the test was (103.2±10.0) %. CONCLUSION: The two ondansetron hydrochloride tablets are bioequivalent.%目的:研究两种盐酸昂丹司琼片在中国健康人体的生物等效性.方法:20名健康男性志愿者随机交叉单剂量口服(8 mg)盐酸昂丹司琼试验制剂与参比制剂,采用液-质联用法测定血浆中昂丹司琼的血药浓度,应用SPSS 13.0统计软件进行统计分析.结果:试验制剂与参比制剂中昂丹司琼的主要药动学参数,Cmax分别为(33±8)和(32±8)μg/L,tmax分别为(1.5±0.3)和(1.5±0.4)h,AUC0~24分别为(176±67)和(168±58)μg·h·L-1,AUC0~∞分别为(188±70)和(182±63)μg·h·L-1.试验制剂对参比制剂的相对生物利用度为(103.2±10.0)%.结论:两种盐酸昂丹司琼片剂具有生物等效性.

  13. Management recommendations: Benton Lake Complex

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This document is a review of land management practices at the Benton Lake Complex, by a land use specialist. Recommendations, time frame and additional comments are...

  14. Management recommendations: Lee Metcalf Refuge

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This document is a review of land management practices at the Lee Metcalf National Wildlife Refuge, by a land use specialist. Recommendations, time frame and...

  15. Management recommendations: Sand Lake Complex

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This document is a review of land management practices at the Sand Lake National Wildlife Refuge, by a land use specialist. Recommendations, time frame and...

  16. RECOMMENDER SYSTEMS IN SOCIAL NETWORKS

    Directory of Open Access Journals (Sweden)

    Cleomar Valois Batista Jr

    2011-12-01

    Full Text Available The continued and diversified growth of social networks has changed the way in which users interact with them. With these changes, what once was limited to social contact is now used for exchanging ideas and opinions, creating the need for new features. Users have so much information at their fingertips that they are unable to process it by themselves; hence, the need to develop new tools. Recommender systems were developed to address this need and many techniques were used for different approaches to the problem. To make relevant recommendations, these systems use large sets of data, not taking the social network of the user into consideration. Developing a recommender system that takes into account the social network of the user is another way of tackling the problem. The purpose of this project is to use the theory of six degrees of separation (Watts 2003 amongst users of a social network to enhance existing recommender systems.

  17. Strategic Arrivals Recommendation Tool Project

    Data.gov (United States)

    National Aeronautics and Space Administration — During the conduct of a NASA Research Announcement (NRA) in 2012 and 2013, the Mosaic ATM team first developed the Strategic Arrivals Recommendation Tool concept,...

  18. Treating Rheumatoid Arthritis to Target : multinational recommendations assessment questionnaire

    NARCIS (Netherlands)

    Haraoui, Boulos; Smolen, Josef S.; Aletaha, Daniel; Breedveld, Ferdinand C.; Burmester, Gerd; Codreanu, Catalin; Da Silva, Jose Pereira; de Wit, Maarten; Dougados, Maxime; Durez, Patrick; Emery, Paul; Fonseca, Joao Eurico; Gibofsky, Allan; Gomez-Reino, Juan; Graninger, Winfried; Hamuryudan, Vedat; Jannaut Pena, Maria Jose; Kalden, Joachim; Kvien, Tore K.; Laurindo, Ieda; Martin-Mola, Emilio; Montecucco, Carlomaurizio; Santos Moreno, Pedro; Pavelka, Karel; Poor, Gyula; Cardiel, Mario H.; Stanislawska-Biernat, Ewa; Takeuchi, Tsutomu; van der Heijde, Desiree

    2011-01-01

    Aim To measure the level of agreement and application of 10 international recommendations for treating rheumatoid arthritis (RA) to a target of remission/low disease activity. Methods A 10-point Likert scale (1=fully disagree, 10=fully agree) measured the level of agreement with each of 10 recommend

  19. SWAT: Social Web Application for Team Recommendation

    OpenAIRE

    Braghin, Stefano; Yong, Jackson Tan Teck; Ventresque, Anthony; Datta, Anwitaman

    2012-01-01

    Team recommendation aids decision support, by not only identifying individuals who are experts for various aspects of a complex task, but also determining various properties of the team as a group. Several aspects such as cohesion and repetition of teams have been identified as important indicators, besides individuals' expertise, in determining how well a team performs. While such information often do not exist explicitly, digital footprint of users' activities can be harnessed to retri...

  20. Recommended Practices for Spreadsheet Testing

    CERN Document Server

    Panko, Raymond R

    2006-01-01

    This paper presents the authors recommended practices for spreadsheet testing. Documented spreadsheet error rates are unacceptable in corporations today. Although improvements are needed throughout the systems development life cycle, credible improvement programs must include comprehensive testing. Several forms of testing are possible, but logic inspection is recommended for module testing. Logic inspection appears to be feasible for spreadsheet developers to do, and logic inspection appears to be safe and effective.

  1. Multimodal System for Recommending Music

    OpenAIRE

    JAKŠA, SILVESTER

    2015-01-01

    Our work discusses development of multimodal music recommendation system. Users of the system are walking on the bridge while using mobile application and the system recommends music according to the walking style, adjusts tempo of the playing song, illuminates the bridge and projects user's positions on the floor. For this particular project we developed electronic boards and used them for all user tracking devices. All electronic boards are merged into common hardware which communicates wit...

  2. Recommendation 93-5 Implementation Plan

    International Nuclear Information System (INIS)

    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

  3. A NEW HYBRID ALGORITHM FOR BUSINESS INTELLIGENCE RECOMMENDER SYSTEM

    Directory of Open Access Journals (Sweden)

    P.Prabhu

    2014-03-01

    Full Text Available Business Intelligence is a set of methods, process and technologies that transform raw data into meaningful and useful information. Recommender system is one of business intelligence system that is used to obtain knowledge to the active user for better decision making. Recommender systems apply data mining techniques to the problem of making personalized recommendations for information. Due to the growth in the number of information and the users in recent years offers challenges in recommender systems. Collaborative, content, demographic and knowledge-based are four different types of recommendations systems. In this paper, a new hybrid algorithm is proposed for recommender system which combines knowledge based, profile of the users and most frequent item mining technique to obtain intelligence.

  4. SPE-UPLC-MS/MS assay for determination of letrozole in human plasma and its application to bioequivalence study in healthy postmenopausal Indian women$

    Institute of Scientific and Technical Information of China (English)

    Pravin G. Vanol; Puran Singhal; Priyanka A. Shah; Jaivik V. Shah; Pranav S. Shrivastav; Mallika Sanyal

    2016-01-01

    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 ex-traction (SPE) of letrozole and letrozole-d4 on Orochem DVB-LP cartridges, chromatography was per-formed on Acquity UPLC BEH C18 (50 mm ? 2.1 mm, 1.7 mm) 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 spec-trometer 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 con-centration range of 0.10–100 ng/mL (r2Z0.9990) using 100 mL human plasma. The extraction recovery of letrozole ranged from 94.3% to 96.2% and the intra-batch and inter-batch precision was r 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.

  5. Rapid and Sensitive LC-MS/MS Method for Quantification of Fexofenadine in Human Plasma——Application to a Bioequivalence Study in Chinese Volunteers

    Institute of Scientific and Technical Information of China (English)

    TENG Guo-sheng; TENG Le-sheng; WU Yi; TANG Yun-biao; LIU Lan-ying; GU Jing-kai

    2007-01-01

    A rapid and sensitive liquid chromatography-tandem mass spectrometry method(LC-MS/MS) was developed and validated for the quantification of fexofenadine in human plasma, to conduct comparative bioavailability studies. Human plasma was extracted with a mixture of dichloromethane-diethyl ether( volume ratio 2:3) in a basic environment and the extract was separated on a C18 column with a mobile phase consisting of acetonitrile-methanol-10 mmol/L amspectrometry in the multiple-reaction-monitoring(MRM) mode. The linearity was within a range of 1-1000 ng/mL.The intra- and inter-day precision were <4.1% and <4.8%, respectively, and the accuracy was in the range of 95.0%-105%. The method was applied to the quantification of fexofenadine human plasma from 20 healthy male Chinese volunteers, according to a single dose, randomized, two-way crossover design with a two-week washout period. The mean values of major pharmacokinetic parameters of ρmax, AUC0-48, AUC0-∞, tmax, and t1/2 were determined from the plasma concentration. The analysis of variance(ANOVA) did not show any significant difference between the two products of fexofenadine and 90% confidence intervals fell within the acceptable range for bioequivalence.

  6. SPE-UPLC-MS/MS method for sensitive and rapid determination of aripiprazole in human plasma to support a bioequivalence study.

    Science.gov (United States)

    Patel, Daxesh P; Sharma, Primal; Sanyal, Mallika; Shrivastav, Pranav S

    2013-04-15

    An improved and rugged UPLC-MS/MS method has been developed and validated for sensitive and rapid determination of aripiprazole in human plasma using aripiprazole-d8 as the internal standard (IS). The analyte and IS were extracted from 100 μL of human plasma by solid-phase extraction using Phenomenex Strata-X (30 mg, 1 cc) cartridges. Chromatography was achieved on an Acquity UPLC BEH C18 (50 mm × 2.1 mm, 1.7 μm) analytical column using methanol: 10mM ammonium formate (85:15, v/v) as the mobile phase with isocratic elution. Quantitation was done using multiple reaction monitoring in the positive ionization mode. The linearity of the method was established in the concentration range 0.05-80 ng/mL. The mean extraction recovery was greater than 96% across QC levels, while intra- and inter batch accuracy and precision (% CV) values ranged from 97.4 to 101.9% and from 1.20 to 3.72% respectively. The relative matrix effect in eight different lots of plasma samples, expressed as % CV for the calculated slopes of calibration curves was 1.08%. The stability of aripiprazole was studied under different storage conditions. The validated method was used to support a bioequivalence study of 10mg aripiprazole formulation in 36 healthy Indian subjects. PMID:23510852

  7. Determination of torasemide in human plasma and its bioequivalence study by high-performance liquid chromatography with electrospray ionization tandem mass spectrometry$

    Institute of Scientific and Technical Information of China (English)

    Lin Zhang; Rulin Wang; Yuan Tian; Zunjian Zhang

    2016-01-01

    A sensitive and selective method using high-performance liquid chromatography coupled with elec-trospray ionization tandem mass spectrometry (HPLC–ESI–MS) to determine the concentration of tor-asemide 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 mm) 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 io-nization 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 (r¼0.9984) 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.

  8. 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.

  9. A rapid and sensitive LC-MS/MS method for determination of lercanidipine in human plasma and its application in a bioequivalence study in Chinese healthy volunteers.

    Science.gov (United States)

    Li, Xiaobing; Shi, Fuguo; He, Xiaojing; Jian, Lingyan; Ding, Li

    2016-09-01

    A rapid and highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the determination of lercanidipine (LER) in human plasma. The plasma sample was deproteinized with methanol after addition of diazepam (internal standard, IS) and separated on a 38°C Hedera ODS-2 analytical column with a mobile phase of methanol and 5mM ammonium acetate buffer solution containing 0.1% formic acid at an isocratic flow rate of 400μL/min. The detection was performed on an API 4000 tandem mass spectrometer coupled with electrospray ionization (ESI) source in positive ESI mode. Quantification was conducted by multiple reaction monitoring (MRM) of the transitions of m/z 612.2→280.2 for LER and m/z 285.1→193.1 for IS, respectively. The method exhibited high sensitivity (LLOQ of 0.015ng/mL) and good linearity over the concentration range of 0.015-8.0ng/mL. No matrix effect and carry-over effect were observed. The values on both the occasions (intra- and inter-day) were all within 15% at three concentration levels. This robust method was successfully applied in a bioequivalence study to evaluate the pharmacokinetics of LER in 59 healthy male Chinese volunteers after a single oral administration of 10mg LER. PMID:27232153

  10. Quantification of sofosbuvir and ledipasvir in human plasma by UPLC-MS/MS method: Application to fasting and fed bioequivalence studies.

    Science.gov (United States)

    Rezk, Mamdouh R; Bendas, Ehab R; Basalious, Emad B; Karim, Iman A

    2016-08-15

    A rapid and sensitive LC-MS/MS method was developed, optimized and validated for quantification of sofosbuvir (SF) and ledipasvir (LD) in human plasma using eplerenone as an internal standard (IS). Analytes and IS were extracted from plasma by simple liquid-liquid extraction technique using methyl tertiary butyl ether. The prepared samples were chromatographed on Acquity UPLC BEH C18 column. Separation was done using a mobile phase formed of 0.1% formic acid and acetonitrile (50:50, v/v) in an isocratic mode at a flow rate of 0.4ml/min. The Xevo TQD LC-MS/MS was operated under the multiple-reaction monitoring mode using electrospray ionization. A full validation of the method was performed according to the FDA guidelines. Linearity was found to be in the range of 0.25-3500ng/ml for SF and 5-2000ng/ml for LD. The intra-day and inter-day precision and accuracy results were within the acceptable limits. A short run time of 2min allows analysis of more than 400 plasma samples per day. The developed method was successfully applied to both fasting and fed bioequivalence studies in healthy human volunteers. PMID:27322631

  11. 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.

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

    Institute of Scientific and Technical Information of China (English)

    Bhupinder Singh; Rama S. Lokhandae; Ashish Dwivedi; Sandeep Sharma; Naveen Dubey

    2014-01-01

    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 Pheno-menex, Gemini NX (100 mm ~ 4.6 mm, 5 mm) 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.

  13. Determination of amlodipine in human plasma using automated online solid-phase extraction HPLC-tandem mass spectrometry: application to a bioequivalence study of Chinese volunteers.

    Science.gov (United States)

    Shentu, Jianzhong; Fu, Lizhi; Zhou, Huili; Hu, Xing Jiang; Liu, Jian; Chen, Junchun; Wu, Guolan

    2012-11-01

    An automated method (XLC-MS/MS) that uses online solid-phase extraction coupled with HPLC-tandem mass spectrometry was reported here for the first time to quantify amlodipine in human plasma. Automated pre-purification of plasma was performed using 10 mm × 2 mm HySphere C8 EC-SE online solid-phase extraction cartridges. After being eluted from the cartridge, the analyte and the internal standard were separated by HPLC and detected by tandem mass spectrometry. Mass spectrometric detection was achieved in the multiple reaction monitoring mode using a quadrupole tandem mass spectrometer in the positive electrospray ionization mode. The XLC-MS/MS method was validated and yielded excellent specificity. The calibration curve ranged from 0.10 to 10.22 ng/mL, and both the intra- and inter-day precision and accuracy values were within 8%. This method proved to be less laborious and was faster per analysis (high-throughput) than offline sample preparation methods. This method has been successfully applied in clinical pharmacokinetic and bioequivalence analyses. PMID:22770846

  14. Liquid Chromatography-electrospray Ionization Tandem Mass Spectrometry for Simultaneous Determination of Metformin and Glimepiride in Beagle Dog Plasma and Bioequivalence Study

    Institute of Scientific and Technical Information of China (English)

    BAI Jing; SHI Xiao-wei; DU Ying-feng; XIANG Bai; WANG Shuai; CAO De-ying

    2012-01-01

    A sensitive and selective liquid chromatography-electrospray ionization tandem mass spectrometry(LC-ESI-MS/MS) was used for the simultaneous determination of metformin and glimepiride in beagle dog plasma with glipizide as internal standard(IS).After simplified protein precipitation with methanol,both the analytes and IS were chromatographed on a Zorbax CN column via gradient elution with methanol(containing 5 mmol/L ammonium acetate) and 5 mmol/L aqueous ammonium acetate as the mobile phase.Detection was performed by multiple reaction monitoring(MRM) scanning via ESI source operated in positive ionization mode.Specificity,linearity,accuracy,precision,recovery,matrix effect and stability were validated for metformin and glimepiride in beagle dog plasma.The calibration curves were linear in a concentration range of 10--10000 ng/mL for metformin and 4--4000 ng/mL for glimepiride with both correlation coefficients higher than 0.99.The recoveries obtained for the analytes and IS were all between 82.7% and 101.2%.The method exhibited excellent performance in terms of selectivity,robustness,short analytical time and simplicity of sample preparation.Finally,the proposed method was applied to a bioequivalence study of self-made bilayer tablet and commercial formulation containing 500 mg of metformin and 1 mg of glimepiride in beagle dogs.

  15. Nuclear Security Recommendations on Radioactive Material and Associated Facilities: Recommendations

    International Nuclear Information System (INIS)

    This publication presents recommendations for the nuclear security of nuclear and other radioactive material that is out of regulatory control. It is based on national experiences and practices and guidance publications in the field of security as well as the nuclear security related international instruments. The recommendations include guidance for States with regard to the nuclear security of nuclear and other radioactive material that has been reported as being out of regulatory control as well as for material that is lost, missing or stolen but has not been reported as such, or has been otherwise discovered. In addition, these recommendations adhere to the detection and assessment of alarms and alerts and to a graded response to criminal or unauthorized acts with nuclear security implications.

  16. Challenging the Long Tail Recommendation

    CERN Document Server

    Yin, Hongzhi; Li, Jing; Yao, Junjie; Chen, Chen

    2012-01-01

    The success of "infinite-inventory" retailers such as Amazon.com and Netflix has been largely attributed to a "long tail" phenomenon. Although the majority of their inventory is not in high demand, these niche products, unavailable at limited-inventory competitors, generate a significant fraction of total revenue in aggregate. In addition, tail product availability can boost head sales by offering consumers the convenience of "one-stop shopping" for both their mainstream and niche tastes. However, most of existing recommender systems, especially collaborative filter based methods, can not recommend tail products due to the data sparsity issue. It has been widely acknowledged that to recommend popular products is easier yet more trivial while to recommend long tail products adds more novelty yet it is also a more challenging task. In this paper, we propose a novel suite of graph-based algorithms for the long tail recommendation. We first represent user-item information with undirected edge-weighted graph and i...

  17. Customization Using Fuzzy Recommender Systems

    Institute of Scientific and Technical Information of China (English)

    Ronald R. Yager

    2004-01-01

    We discuss some methods for constructing recommender systems. An important feature of the methods studied here is that we assume the availability of a description, representation, of the objects being considered for recommendation. The approaches studied here differ from collaborative filtering in that we only use pReferences information from the individual for whom we are providing the recommendation and make no use the preferences of other collaborators. We provide a detailed discussion of the construction of the representation schema used. We consider two sources of information about the users preferences. The first are direct statements about the type of objects the user likes. The second source of information comes from ratings of objects which the user has experienced.

  18. Personalized recommendation with corrected similarity

    International Nuclear Information System (INIS)

    Personalized recommendation has attracted a surge of interdisciplinary research. Especially, similarity-based methods in applications of real recommendation systems have achieved great success. However, the computations of similarities are overestimated or underestimated, in particular because of the defective strategy of unidirectional similarity estimation. In this paper, we solve this drawback by leveraging mutual correction of forward and backward similarity estimations, and propose a new personalized recommendation index, i.e., corrected similarity based inference (CSI). Through extensive experiments on four benchmark datasets, the results show a greater improvement of CSI in comparison with these mainstream baselines. And a detailed analysis is presented to unveil and understand the origin of such difference between CSI and mainstream indices. (paper)

  19. Desidratação e recomendações para a reposição hídrica em crianças fisicamente ativas Dehydration and rehydration recommendations for physically active children

    Directory of Open Access Journals (Sweden)

    Luciana Rossi

    2010-09-01

    heat production. Most studies that address the risks of dehydration and provide recommendations for restoring water are directed to adults living in temperate climate regions, but little is known about the needs of restoring water to physically active children in tropical regions. This review discusses the recommendations for this population and the risks of sports practice in tropical climate areas. DATA SOURCE: Systematic analysis of the national (SciELO and international (Medline literature from 1972 to 2009, with the following keywords, alone or in combination, in Portuguese and English: hydration, children, dehydration and water replacement. DATA SYNTHESIS: There are risks related to dehydration and possible development of hyperthermia especially in adverse weather conditions without adequate fluid replacement. The main trigger for hyperthermia is that, compared to adults, children are less able of adapting to extremes of temperature due to their higher body surface area and lower capacity of thermoregulation by evaporation. Studies on this subject are scarce in face of the questions still open. CONCLUSIONS: Once dehydration factors are known, the best recommendation to aggressive climatic conditions is to establish a replacement program using flavored hydration beverage added with carbohydrates and sodium in order to avoid significant water losses and reduced performance, and to decrease health risks posed by hyperthermia and dehydration to physically active children.

  20. An LC-MS/MS method for simultaneous determination of cefprozil diastereomers in human plasma and its application for the bioequivalence study of two cefprozil tablets in healthy Chinese volunteers.

    Science.gov (United States)

    Liu, Min; Ma, Jing-Yi; Zhang, Yanan; Wang, Xiaolin; Zhao, Hongna; Du, Aihua; Yang, Man; Meng, Lingjie; Deng, Ming; Liu, Huichen

    2016-03-01

    A rapid and sensitive liquid chromatography-tandem mass spectrometric method was developed for the first time and validated for the determination of cefprozil diastereomers in human plasma. The plasma samples were prepared by protein precipitation using acetonitrile. Detection was performed using an electronic spray ion source in the negative ion mode, operating in the multiple reaction monitoring of the transitions m/z 388.0 to m/z 205.0 for cefprozil diastereomers and m/z 346.1 to m/z 268.1 for cephalexin (the internal standard). The calibration curves of cis-cefprozil and trans-cefprozil were linear in the ranges 0.125-16.0 µg/mL and 0.0403-1.72 µg/mL, respectively. The lower limits of quantification of cis- and trans-cefprozil were 0.125 and 0.0403 µg/mL in human plasma, respectively. The intra- and inter-day precisions of cis- and trans-cefprozil were all <9.7%, and the accuracy ranged from 99.2 to 104.7% and from 100.6 to 102.2%, respectively. The validated method was successfully applied to a bioequivalence study of two cefprozil formulations in 24 healthy Chinese volunteers. The two cefprozil tablets were bioequivalent by measurement of cis-, trans- and total cefprozil. We suggest that the bioequivalence of cefprozil formulations can be evaluated only using cis-cefprozil as the analyte in future studies. PMID:26129932

  1. An open-label, phase 2, single centre, randomized, crossover design bioequivalence study of AndroForte 5 testosterone cream and Testogel 1% testosterone gel in hypogonadal men: study LP101.

    Science.gov (United States)

    Wittert, G A; Harrison, R W; Buckley, M J; Wlodarczyk, J

    2016-01-01

    We compared a novel 5% testosterone (T) cream (AndroForte 5, Lawley Pharmaceuticals, Australia) with a 1% T gel (Testogel, Besins Healthcare, Australia). Using an open-label crossover design, subjects were randomized to one of two treatment sequences using either the T gel or T cream first in a 1 : 1 ratio. Each treatment period was 30 days with a 7-14 days washout period between them. On Days 1 and 30 of each treatment period blood was sampled at -15, -5 min, 0, 2, 4, 5, 6, 7, 8, 9, 10, 12 and 16 h post study drug administration. Sixteen men with established androgen deficiency aged between 29 and 73 years, who had undertaken a washout from prior testosterone therapy participated in the study. One subject failed to complete both arms and another was excluded post-completion because of a major protocol violation. Bioequivalence was established based on key pharmacokinetic (PK) variables: AUC, C(avg), C(max), T(max), % fluctuation (with and without baseline correction) for the two formulations of testosterone on Day 1 and Day 30. The ratio and 90% CI of AUC 0.99 (0.86-1.14), C(max) 1.02 (0.84-1.24) and C(avg) 0.99 (0.86-1.14) for T cream/T gel were within the predetermined bio-equivalence criteria of 80% to 125% at Day 30. There were no statistically significant differences between secondary biochemical markers: serum dihydrotestosterone (DHT), oestradiol (E2), sex hormone-binding globulin (SHBG), luteinizing hormone (LH) and (FSH). The two testosterone formulations were shown to be bioequivalent. PMID:26754331

  2. 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.

  3. An Improved Adaptive model for Information Recommending and Spreading

    Institute of Scientific and Technical Information of China (English)

    CHEN Duan-Bing; GAO Hui

    2012-01-01

    People in the Internet era have to cope with information overload and expend great effort on finding what they need.Recent experiments indicate that recommendations based on users' past activities are usually less favored than those based on social relationships,and thus many researchers have proposed adaptive algorithms on social recommendation.However,in those methods,quite a number of users have little chance to recommend information,which might prevent valuable information from spreading.We present an improved algorithm that allows more users to have enough followers to spread information.Experimental results demonstrate that both recommendation precision and spreading effectiveness of our method can be improved significantly.%People in the Internet era have to cope with information overload and expend great effort on finding what they need. Recent experiments indicate that recommendations based on users' past activities are usually less favored than those based on social relationships, and thus many researchers have proposed adaptive algorithms on social recommendation. However, in those methods, quite a number of users have little chance to recommend information, which might prevent valuable information from spreading. We present an improved algorithm that allows more users to have enough followers to spread information. Experimental results demonstrate that both recommendation precision and spreading effectiveness of our method can be improved significantly.

  4. New software for carrying out data analysis of bioavailability and bioequivalence testing%生物利用度和生物等效性分析软件简介

    Institute of Scientific and Technical Information of China (English)

    陈志扬; 谢海棠; 孙瑞元; 胡刚

    2007-01-01

    Generic drug products (test products: drug A, B...) are bioequivalent to an innovator product (reference product) when their bioavailabilities in the same molar dose are similar. Bioavailability is usually expressed by following pharmacokinetic parameters: the area under plasma concentration-time curve (AUC), the maximum plasma concentration (Cmax) and the time of maximum plasma concentration (tmax). This paper used a two period crossover bioequivalence study to develop convenient, friendly user interface software, BA&BE Analysis to statistically process data in clinical pharmacology studies and other areas. The method involves user input of data for analysis into a grid format, setting variables and parameters, followed by one-way analysis of variance (ANOVA), bioavailability and bioequivalence analysis of the data. The software developed in the present study should help scientists to carry out data analysis of bioavailability and bioequivalence testing quickly and easily.%考虑生物利用度的影响因素,仿制药物(或制剂)与参比对象采用相同的等效剂量,应能达到生物等效.生物利用度一般用以下几个药代动力学参数衡量:曲线下面积(AUC),峰浓度(Cmax),达峰时间(tmax).本论文以双交叉生物等效性试验为例,介绍自主开发的生物等效性分析软件BA&BE,该软件使用便捷、界面友好,可用于临床药理和新药研发等相关领域.软件允许用户直接在网格界面进行数据录入,设置变量和参数.系统便可自行对原始数据进行方差分析(ANOVA)、生物利用度和生物等效性的计算并生成报表.该软件将有助于科研人员更迅速、准确地进行数据分析和提交结果.

  5. Consideration on the bioequivalence study of imatinib mesylate oral products%关于甲磺酸伊马替尼口服制剂生物等效性试验设计的几点考虑

    Institute of Scientific and Technical Information of China (English)

    陈晓媛; 杨劲

    2014-01-01

    人体生物等效性试验是支持仿制药上市的主要临床依据。抗肿瘤药物生物等效性试验有其特殊性,需要结合产品特点、研究目标以及临床可操作性等综合考虑。小分子靶向药物具有与传统细胞毒类药物不同的安全有效性特点,也使得其生物等效性设计有所不同。伊马替尼作为首个上市的小分子酪氨酸激酶抑制剂,其化合物专利已到期成为可仿制产品。本文结合该品种审评中遇到的问题及国外相关指导原则,阐述了当前审评中对伊马替尼人体生物等效性试验设计中一些问题的考虑,期望能为该产品相关研发人员提供参考。%Bioequivalence tests are primary clinical evidence for approval of generic drugs .The bioequivalence tests of anti -cancer drug possess particularities, therefore, a combination of product characteristics , clini-cal research objective ,and clinical operability is required to be taken into consideration for design of study protocol .Targeted small molecule drugs are different from conventional cytotoxic drugs on safety and effective-ness , accordingly , making its bioequivalence design distinct from others . Imatinib is the first small molecule tyrosine kinase inhibitor listed , and the compound patent has expired to become generic product .In this paper , problems occurred in the process of drug evaluation and related guidance abroad were reviewed and analyzed , and considerations on bio-equivalence test design of imatinib was elaborated , hoping to provide reference for product development personnel .

  6. PHARMACOKINETIC AND BIOEQUIVALENCE COMPARISON BETWEEN EXTENDED RELEASE CAPSULES OF VENLAFAXINE HYDROCHLORIDE 150MG: AN OPEN LABEL, BALANCED, RANDOMIZED-SEQUENCE, SINGLE-DOSE, TWO-PERIOD CROSSOVER STUDY IN HEALTHY INDIAN MALE VOLUNTEERS

    Directory of Open Access Journals (Sweden)

    I.Sarath chandiran

    2011-03-01

    Full Text Available This bioequivalence study was designed to determine the pharmacokinetic, bioavailability and bioequivalence of Venlafaxine HCl 150 mg Extended Release Capsules in comparison with Effexor®-XR 150mg Extended Release Capsules after single dose administration under fed conditions in 20 healthy adult male subjects. Therefore the design of an open label, balanced, randomized, two-sequence, single dose, two way crossover study with a washout period of at least 7 days was used.Each volunteer received a 150 mg capsule of the reference or test drug respectively. On the day of dosing, blood samples were collected before dosing and at various time points up to 72 hours after dosing. Analysis of venlafaxine and its metabolite O-Desmethylvenlafaxine concentrations was performed using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS method. The pharmacokinetic parameters including Cmax, AUC0-t, AUC0-inf, Tmax, t1/2 and Kel were analyzed using the non-compartmental model. Drug safety and tolerability were assessed.The pharmacokinetic parameters including Cmax, AUC0-t, AUC0-inf, Tmax, t1/2 and Kel were analyzed using the non-compartmental model. Drug safety and tolerability were assessed. The primary pharmacokinetic parameters (Cmax, AUC0-t and AUC0-inf 90%CI were within the 80 to 125% interval required for bioequivalence as stipulated in the current regulations of the USFDA acceptance criteria. The geometric mean ratios (Test/Reference between the two products of extended-release venlafaxine capsule under fed condition were 104.91% (92.86%-118.53% and 114.41% (103.43%-124.55% for Cmax ratios, 102.24% (95.95%-108.94% and 105.27% (96.76%-114.53% for AUC0-t ratios and 101.66% (95.73%-107.97% and 104.71% (96.13%-114.05% for AUC0-inf ratios of Venlafaxine and its metabolite O-Desmethylvenlafaxine (ODV respectively. 20 volunteers had completed both treatment periods. There was no significant difference of the Tmax parameter between the two

  7. Ubiquitous Multicriteria Clinic Recommendation System.

    Science.gov (United States)

    Chen, Toly

    2016-05-01

    Advancements in information, communication, and sensor technologies have led to new opportunities in medical care and education. Patients in general prefer visiting the nearest clinic, attempt to avoid waiting for treatment, and have unequal preferences for different clinics and doctors. Therefore, to enable patients to compare multiple clinics, this study proposes a ubiquitous multicriteria clinic recommendation system. In this system, patients can send requests through their cell phones to the system server to obtain a clinic recommendation. Once the patient sends this information to the system, the system server first estimates the patient's speed according to the detection results of a global positioning system. It then applies a fuzzy integer nonlinear programming-ordered weighted average approach to assess four criteria and finally recommends a clinic with maximal utility to the patient. The proposed methodology was tested in a field experiment, and the experimental results showed that it is advantageous over two existing methods in elevating the utilities of recommendations. In addition, such an advantage was shown to be statistically significant.

  8. Ubiquitous Multicriteria Clinic Recommendation System.

    Science.gov (United States)

    Chen, Toly

    2016-05-01

    Advancements in information, communication, and sensor technologies have led to new opportunities in medical care and education. Patients in general prefer visiting the nearest clinic, attempt to avoid waiting for treatment, and have unequal preferences for different clinics and doctors. Therefore, to enable patients to compare multiple clinics, this study proposes a ubiquitous multicriteria clinic recommendation system. In this system, patients can send requests through their cell phones to the system server to obtain a clinic recommendation. Once the patient sends this information to the system, the system server first estimates the patient's speed according to the detection results of a global positioning system. It then applies a fuzzy integer nonlinear programming-ordered weighted average approach to assess four criteria and finally recommends a clinic with maximal utility to the patient. The proposed methodology was tested in a field experiment, and the experimental results showed that it is advantageous over two existing methods in elevating the utilities of recommendations. In addition, such an advantage was shown to be statistically significant. PMID:26984357

  9. Recommendations for open data science

    OpenAIRE

    Gymrek, Melissa; Farjoun, Yossi

    2016-01-01

    Life science research increasingly relies on large-scale computational analyses. However, the code and data used for these analyses are often lacking in publications. To maximize scientific impact, reproducibility, and reuse, it is crucial that these resources are made publicly available and are fully transparent. We provide recommendations for improving the openness of data-driven studies in life sciences.

  10. 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.

  11. Pharmacokinetics and Bioequivalence of Two Formulations of Febuxostat 40-Mg and 80-Mg Tablets: A Randomized, Open-Label, 4-Way Crossover Study in Healthy Chinese Male Volunteers.

    Directory of Open Access Journals (Sweden)

    Zhu Luo

    Full Text Available The present study aimed to investigate the pharmacokinetic properties of febuxostat in healthy Chinese male volunteers and evaluate whether the two formulations of febuxostat 40-mg and 80-mg tablets are bioequivalent. A randomized, open-label, 4-way crossover study was conducted in healthy Chinese male volunteers under fasting conditions. 24 eligible subjects were randomized in a 1:1:1:1 ratio to receive a single dose of test or reference formulation of febuxostat 40-mg or 80-mg tablet. The washout period between each administration was 1 week. Plasma febuxostat was quantified by a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS method. Tolerability was evaluated by monitoring adverse events, physical examinations, 12-lead ECG and laboratory tests. After single-dosing of 1 tablet of 40-mg febuxostat, the pharmacokinetic parameters of test and reference formulations were: Tmax 1.22±0.87 and 1.85±1.03 h, Cmax 1689.16±461.31 and 1613.80±608.43 ng·mL-1, AUC0-t 5139.87±1349.28 and 5517.91±2024.26 ng·mL-1·h, AUC0-∞ 5263.06±1339.16 and 5640.48±2040.22 ng·mL-1·h, t1/2 4.82±2.61 and 4.85±1.78 h, respectively. After single-dosing of 1 tablet of 80-mg febuxostat, the pharmacokinetic parameters of test and reference formulations were: Tmax 1.71±1.21 and 2.23±1.55 h, Cmax 2744.47±1157.44 and 2998.17±1200.13 ng·mL-1, AUC0-t 9634.03±2768.25 and 10467.95±3501.65 ng·mL-1·h, AUC0-∞ 9834.32±2730.51 and 10626.63±3504.08 ng·mL-1·h, t1/2 6.25±2.44 and 5.46±1.65 h, respectively. For single-dosing of 1 tablet of 40-mg febuxostat, 90% CIs for the test/reference ratio of AUC0-t, AUC0-∞ and Cmax were 89.79 to 102.55, 90.14 to 102.56 and 93.99 to 129.63, respectively. For single-dosing of 1 tablet of 80-mg febuxostat, 90% CIs for the test/reference ratio of AUC0-t, AUC0-∞ and Cmax were 86.67 to 100.00, 87.50 to 100.51 and 79.48 to 105.99, respectively. This single dose study revealed similar pharmacokinetic

  12. Bioequivalence evaluation of secnidazole tablets in healthy male volunteers%塞克硝唑片剂健康人体生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    师少军; 李忠芳; 万元胜; 陈华庭; 曾繁典

    2007-01-01

    AIM: To compare the bioavailability of the test and reference formulation of secnidazole (2 g) tablets under fasting conditions. METHODS: This bioequivalence study was carried out in 20 healthy male Chinese volunteers according to a single dose, two-sequence, crossover randomized design. Fifteen blood samples per period were collected over 96 h, and plasma secnidazole concentrations were determined by locally validated high performance liquid chromatography (HPLC) assay and pharmacokinetic parameters were analyzed by the non-compartmental and compartmental methods. RESULTS: Plasma concentration-time profiles were adequately described by a one-compartment open model with first-order absorption. The main pharmacokinetic parameters of secnidazole test and reference tablets were as follows: tmax were (2.30±1.06) and (2.28±1.10) h, Cmax were (49.63±6.35) and (46.17±4.24) mg/L, t1/2 were (28.84±3.41) and (29.05±4.01) h, AUC0-96 were (1832.06±180.15) and (1847.14±204.14) mg·h-1·L-1, respectively. The relative bioavailability of test tablets was (99.99±11.92)%. CONCLUSION: The results indicate that the two formulations of secnidazole tablets are bioequivalent in the rate and extent of absorption.%目的:研究塞克硝唑试验片与参比片的生物利用度,并进行生物等效性评价.方法:20名健康男性志愿者单剂量口服塞克硝唑试验或参比制剂各2 g;采用反相高效液相色谱法测定其血药浓度.结果:人体药动学研究表明,口服塞克硝唑片的药-时曲线符合一级吸收的单房室模型.试验片与参比片的主要药代动力学参数:tmax分别为(2.30±1.06)和(2.28±1.10) h;Cmax分别为(49.63±6.35)和(46.17±4.24) mg/L;t1/2 分别为(28.84±3.41)和(29.05±4.01) h;AUC0-96 分别为(1832.06±180.15)和(1847.14±204.14) mg·h-1·L-1;相对生物利用度为(99.99±11.92)%.结论:塞克硝唑片两种制剂具有生物等效性.

  13. Bioequivalence of Glimepiride Dispersible Tablets in Healthy Volunteers%格列美脲分散片人体生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    周伦; 丁莉坤; 杨静; 宋薇; 陈敏纯; 王茂湖; 文爱东

    2012-01-01

    目的:比较两种格列美脲制剂的人体生物等效性.方法:20名健康男性志愿者随机交叉口服单剂量格列美脲分散片(受试制剂)与格列美脲片(参比制剂)2 mg,采用HPLC-MS法测定血浆中格列美脲浓度,用DAS 2.1软件计算药动学参数和生物利用度.结果:口服格列美脲受试制剂与参比制剂后的药动学参数分别为Cmax( 135.4±40.3)和(146.5±39.2) ng·ml-1,tmax(3.2±1.2)和(2.8±0.9)h,t1/2(7.3±3.9)和(6.7±2.8)h,AUC0~36 (757.1±217.2)和(849.4±250.4 )ng·h·ml-1,AUC0~∞(784.0±217.4)和(871.5±265.2) ng·h·ml-1.受试制剂的相对生物利用度为(90.7±17.5)%.结论:两种格列美脲制剂具有生物等效性.%Objective; To investigate the bioequivalence of two glimepiride preparations in healthy volunteers. Method; 2 mg glimepiride dispersible tablets or glimepiride tablets were given to 20 healthy male volunteers in a randomized two-way crossover design and the plasma drug concentration was assayed by LC-MS. The pharmacokinetic parameters were calculated by DAS 2. 1 software. Result ; The main pharmacokinetie parameters of test and reference preparations were as follows: C^, of ( 135.4 ± 40. 3 ) rig-ml"' and (146.5 ±39.2) ng-ml'.^of (3.2±1.2)h and (2.8±0.9)h, w of (7.3 ±3.9) h and (6.7±2.8)h, AUC0.y, of (757. 1 ± 217.2)ng-h -ml"1 and (849.4 ±250.4) ng-h -ml"', AUC0_. Of (784.0 ±217.4) and (871.5 ±265.2) ng -h -ml"1, respectively. The relative bioavailability was (90. 7 ± 17.5)%. Conclusion; The two formulations are bioequivalent.

  14. 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. PMID:25834837

  15. 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...

  16. 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.

  17. Virtual Goods Recommendations in Virtual Worlds

    Directory of Open Access Journals (Sweden)

    Kuan-Yu Chen

    2015-01-01

    Full Text Available 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.

  18. In vitro studies are sometimes better than conventional human pharmacokinetic in vivo studies in assessing bioequivalence of immediate-release solid oral dosage forms.

    Science.gov (United States)

    Polli, James E

    2008-06-01

    Human pharmacokinetic in vivo studies are often presumed to serve as the "gold standard" to assess product bioequivalence (BE) of immediate-release (IR) solid oral dosage forms. However, when this general assumption is re-visited, it appears that in vitro studies are sometimes better than in vivo studies in assessing BE of IR solid oral dosage forms. Reasons for in vitro studies to sometimes serve as the better method are that in vitro studies: (a) reduce costs, (b) more directly assess product performance, and (c) offer benefits in terms of ethical considerations. Reduced costs are achieved through avoiding in vivo studies where BE is self-evident, where biopharmaceutic data anticipates BE, and where in vivo BE study type II error is high. In vitro studies more directly assess product performance than do conventional human pharmacokinetic BE studies, since in vitro studies focus on comparative drug absorption from the two products, while in vivo BE testing can suffer from complications due to its indirect approach. Regarding ethical considerations, in vitro studies better embrace the principle "No unnecessary human testing should be performed" and can result in faster development. Situations when in vitro test should be viewed as preferred include Class I drugs with rapid dissolution, Class III drugs with very rapid dissolution, and highly variable drugs with rapid dissolution and that are not bio(equivalence)problem drugs. Sponsors of potential in vivo human pharmacokinetic BE testing should be required to justify why in vitro data is insufficient, similar to proposed animal testing requires justification to not employ an in vitro approach. PMID:18500564

  19. 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.

  20. Nuclear Security Recommendations on Radioactive Material and Associated Facilities: Recommendations (Spanish Edition)

    International Nuclear Information System (INIS)

    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.

  1. Nuclear Security Recommendations on Radioactive Material and Associated Facilities: Recommendations (Arabic Edition)

    International Nuclear Information System (INIS)

    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.

  2. 2种盐酸氨溴索制剂的人体生物等效性研究%Bioequivalence Study of 2 Kinds of Ambroxol Hydrochloride Preparations

    Institute of Scientific and Technical Information of China (English)

    王曦; 何海霞

    2011-01-01

    OBJECTIVE: To study the bioequivalence of Ambroxol hydrochloride granules and Ambroxol hydrochloride tablets.METHODS: A randomized crossover design was performed in 18 healthy volunteers.In the two study periods, a single oral dose of Ambroxol hydrochloride granules (trial preparation) 60 mg or Ambroxol hydrochloride tablets (reference preparation) 60 mg were administered to each volunteers.Plasma concentrations of ambroxol hydrochloride were measured by HPLC.The pharmacokinetic parameters as well as bioequivalence were measured by 3p97 software.RESULTS: The plasma concentration-time curves of trial preparation and reference preparation were in line with one compartment open model.Main pharmacokinetic parameters of trial preparation vs.reference preparation were as follows: t1/2ke,(4.05 ± 1.89) h vs.(4.39 ± 2.14) h; tmax(2.00 ± 0.48) h vs.(1.75 ± 0.71) h; Cmax( 154.59 ± 65.64) ng·mL-1 vs.(153.95 ± 70.21) ng·mL-1; AUC0~24(954.96 ± 419.86)ng·h·mL-1 vs.(951.63 ± 463.38)ng·h· mL-1; AUC0~∞( 1 098.64 ± 469.63) ng·h·mL-1 vs.(1 158.98 ± 505.57) ng·h·mL-1 respectively.The relative bioavailability of Ambroxol hydrochloride granule was( 100.35 ± 14.82)%.Results of variance analysis, t-test and (1- 2 α )confidence interval showed that there was no significant difference in pharmacokinetic parameters (P>0.05).CONCLUSION: The result of statistical analysis shows that the two preparations are bioequivalent.%目的:研究盐酸氨溴索颗粒与盐酸氨溴索片的人体生物等效性.方法:18名男性健康志愿者随机交义单剂量口服盐酸氨溴索颗粒(受试制剂)或盐酸氨溴索片(参比制剂)60mg后,采用高效液相色谱法测定血药浓度,用3p97软件计算二者的药动学参数,并评价其生物等效性.结果:受试制剂与参比制剂的药-时曲线符合口服吸收一室模型.二者药动学参数分别为:t1/2Ke(4.05±1.89)、(4.39±2.14)h;tmax(2.00±0.48)、(1.75±0.71)h;cmax(154.59±65.64)、(153.95±70

  3. 溴莫普林胶囊人体生物等效性研究%Bioequivalence of brodimoprim capsules in 18 healthy volunteers

    Institute of Scientific and Technical Information of China (English)

    张鉴; 王本杰; 郭瑞臣

    2001-01-01

    目的评价国产溴莫普林胶囊与进口hyprim片的生物等效性,为其临床应用提供试验依据。方法采用单剂双交叉试验设计,以乙萘酚为内标,采用高效液相色谱法测定血中溴莫普林浓度,计算药代动力学参数及试验制剂的相对生物利用度,评价两制剂的生物等效性。结果溴莫普林试验制剂和参比制剂主要药代动力学参数t1/2(α)分别为(2.1±1.0)和(1.9±0.9)h,t1/2(α)分别为(43.2±4.8)和(42.4±4.3)h,Tpeak分另别为(3.4±1.6)和(3.1±1.5)h,Cmax分别为(5.9±0.9)和(5.9±1.0)μg·ml-1,AUC0-132分别为(360.2±55.3)和(358.7±52.6)μg·h·ml-1,AUC0~∞分别为(423.8±56.0)和(422.5±51.1)μg·h·ml-1。试验制剂溴莫普林胶囊相对生物利用度F为(99.7±4.8)%。结论溴莫普林试验制剂和参比制剂单剂口服双交叉试验AUG~132无显著性差异(P>0.05)。进一步双单侧t检验和(1~2α)置信区间分析个体间、周期间和剂型间符合生物等效的假设,即溴莫普林胶囊和进口hyprim片为生物等效制剂。%Aim To evaluate the bioequivalence of demestic brodimoprim capsules and imported hyprim tablets and provide experimental basis for clinical application. Methods A single dosage of Brodimoprim or hyprim was given to 18 healthy volunteers in a randomized 2-way cross-over test and the brodimoprim concentrations in plasma were determined by HPLC with β-naphtol as internal standard. The pharmacokinetic parameters and the relative bioavailability of the two preparations were calculated and their bioequivalence was evaluated. Results The major pharmacokinetic parameters of test and reference preparations were as follows respectively: t1/2(α) (2.1 + 1.0) and (1.9+± 0.9) h, t1/3(β)(43.2±4.8) and (42.4±4.3)h, Tpeak(3.4±1.6) and (3.1±1.5) h,Cmax(5.9+ 0.9) and (5.9±1.0)μg · ml-1, AUC0~132(360.2± 55.3) and (358.7±52.6) μg · h · ml-1, AUC0~∞ (423.8±56.0) and (422.5±51.1) μg · h · ml-1. The

  4. Recommender Systems by means of Information Retrieval

    CERN Document Server

    Costa, Alberto

    2010-01-01

    In this paper we present a method for reformulating the Recommender Systems problem in an Information Retrieval one. In our tests we have a dataset of users who give ratings for some movies; we hide some values from the dataset, and we try to predict them again using its remaining portion (the so-called "leave-n-out approach"). In order to use an Information Retrieval algorithm, we reformulate this Recommender Systems problem in this way: a user corresponds to a document, a movie corresponds to a term, the active user (whose rating we want to predict) plays the role of the query, and the ratings are used as weigths, in place of the weighting schema of the original IR algorithm. The output is the ranking list of the documents ("users") relevant for the query ("active user"). We use the ratings of these users, weighted according to the rank, to predict the rating of the active user. We carry out the comparison by means of a typical metric, namely the accuracy of the predictions returned by the algorithm, and we...

  5. IVOA Recommendation: IVOA Support Interfaces

    CERN Document Server

    Graham, Matthew; Grid,

    2011-01-01

    This document describes the minimum interface that a (SOAP- or REST-based) web service requires to participate in the IVOA. Note that this is not required of standard VO services developed prior to this specification, although uptake is strongly encouraged on any subsequent revision. All new standard VO services, however, must feature a VOSI-compliant interface. This document has been produced by the Grid and Web Services Working Group. It has been reviewed by IVOA Members and other interested parties, and has been endorsed by the IVOA Executive Committee as an IVOA Recommendation. It is a stable document and may be used as reference material or cited as a normative reference from another document. IVOA's role in making the Recommendation is to draw attention to the specification and to promote its widespread deployment. This enhances the functionality and interoperability inside the Astronomical Community.

  6. Mania: diagnosis and treatment recommendations.

    Science.gov (United States)

    Malhi, Gin S; Tanious, Michelle; Berk, Michael

    2012-12-01

    This article provides recommendations for the diagnosis and treatment of mania, which characterizes bipolar I disorder (BD I). Failure to detect mania leads to misdiagnosis and suboptimal treatment. To diagnose mania, clinicians should include a detailed mood history within their assessment of patients presenting with depression, agitation, psychosis or insomnia. With regards to treatment, by synthesizing the findings from recent treatment guidelines, and reviewing relevant literature, this paper has distilled recommendations for both acute and long-term management. Antimanic agents including atypical antipsychotics and traditional mood stabilizers are employed to reduce acute manic symptoms, augmented by benzodiazepines if needed, and in refractory or severe cases with behavioural and/or psychotic disturbance, electroconvulsive therapy may occasionally be necessary. Maintenance/prophylaxis therapy aims to reduce recurrences/relapse, for which the combination of psychological interventions with pharmacotherapy is beneficial as it ensures adherence and monitoring of tolerability. PMID:22986995

  7. Recommended HSE-7 documents hierarchy

    International Nuclear Information System (INIS)

    This report recommends a hierarchy of waste management documents at Los Alamos National Laboratory (LANL or ''Laboratory''). The hierarchy addresses documents that are required to plan, implement, and document waste management programs at Los Alamos. These documents will enable the waste management group and the six sections contained within that group to satisfy requirements that are imposed upon them by the US Department of Energy (DOE), DOE Albuquerque Operations, US Environmental Protection Agency, various State of New Mexico agencies, and Laboratory management

  8. Recommendation in the Social Web

    OpenAIRE

    Burke, Robin; DePaul University; Gemmell, Jonathan; Depaul University; Hotho, Andreas; University of Wuerzburg; Jäschke, Robert; University of Kassel

    2011-01-01

    Recommender systems are a means of personalizing the presentation of information to ensure that users see the items most relevant to them. The social web has added new dimensions to the way people interact on the Internet, placing the emphasis on user-generated content. Users in social networks create photos, videos and other artifacts, collaborate with other users, socialize with their friends and share their opinions online. This outpouring of material has brought increased attention to rec...

  9. Recommendation Technologies for Configurable Products

    OpenAIRE

    Falkner, Andreas; Siemens AG Austria; Felfernig, Alexander; Graz University of Technology; Haag, Albert; SAP AG

    2011-01-01

    State of the art recommender systems support users in the selection of items from a predefined assortment (for example, movies, books, and songs). In contrast to an explicit definition of each individual item, configurable products such as computers, financial service portfolios, and cars are repre¬sented in the form of a configuration knowledge base that describes the properties of allowed instances. Although the knowledge representation used is different compared to non-confi¬gurable produc...

  10. Finding and Recommending Scholarly Articles

    Science.gov (United States)

    Kurtz, Michael J.; Henneken, Edwin A.

    2014-05-01

    The rate at which scholarly literature is being produced has been increasing at approximately 3.5 percent per year for decades. This means that during a typical 40 year career the amount of new literature produced each year increases by a factor of four. The methods scholars use to discover relevant literature must change. Just like everybody else involved in information discovery, scholars are confronted with information overload. Two decades ago, this discovery process essentially consisted of paging through abstract books, talking to colleagues and librarians, and browsing journals. A time-consuming process, which could even be longer if material had to be shipped from elsewhere. Now much of this discovery process is mediated by online scholarly information systems. All these systems are relatively new, and all are still changing. They all share a common goal: to provide their users with access to the literature relevant to their specific needs. To achieve this each system responds to actions by the user by displaying articles which the system judges relevant to the user's current needs. Recently search systems which use particularly sophisticated methodologies to recommend a few specific papers to the user have been called "recommender systems". These methods are in line with the current use of the term "recommender system" in computer science. We do not adopt this definition, rather we view systems like these as components in a larger whole, which is presented by the scholarly information systems themselves. In what follows we view the recommender system as an aspect of the entire information system; one which combines the massive memory capacities of the machine with the cognitive abilities of the human user to achieve a human-machine synergy.

  11. Nutrition for Tennis: Practical Recommendations

    OpenAIRE

    Ranchordas, Mayur K.; David Rogerson; Alan Ruddock; Sophie, C. Killer; Winter, Edward M.

    2013-01-01

    Tennis is a pan-global sport that is played year-round in both hemispheres. This places notable demands on the physical and psychological preparation of players and included in these demands are nutritional and fluid requirements both of training and match- play. Thus, the purpose of this article is to review nutritional recommendations for tennis. Notably, tennis players do not excel in any particular physiological or anthropometric characteristic but are well adapted in all areas which is p...

  12. Economic assessment of nutritional recommendations

    OpenAIRE

    Irz, Xavier; Leroy, Pascal; Réquillart, Vincent; Soler, Louis-Georges

    2014-01-01

    The effect of consumers’ compliance with nutritional recommendations is uncertain because of potentially complex substitutions. To lift this uncertainty, we adapt a model of consumer behaviour under rationing to the case of linear nutritional constraints. Dietary adjustments are thus derived from information on consumer preferences, consumption levels, and nutritional contents of foods. A calibration exercise simulates, for different income groups, how the French diet would respond to various...

  13. Promoting cold-start items in recommender systems.

    Directory of Open Access Journals (Sweden)

    Jin-Hu Liu

    Full Text Available 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.

  14. 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

  15. 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

  16. 药品注册生物等效性试验中常见问题分析%Analysis on common defects in bioequivalence studies of drug registrations

    Institute of Scientific and Technical Information of China (English)

    张玉琥

    2011-01-01

    文中对目前药品注册申请中生物等效性试验方面常见的问题进行了分析讨论,重点讨论了试验设计、参比制剂选择、试验样品制备及检验、生物样本测定方法等方面的常见问题,并对试验样品的提供与保存、餐后生物等效性试验、生物等效判定标准等需要进一步关注的问题进行讨论,提出了相关建议.%This article analyzed and discussed the common defects in bioequivalence studies of drug registrations, such as defects concerned with test design, choosing of reference drug product, manufacture and assay of test drug product, bioanalytical method etc. The discussion also dealt with considerations and suggestions on handling and retention of test samples, food-effect bioavailability and bioequivalence limit.

  17. Consideration about the maximum concentration confidence interval limits in the assessment of bioequivalence%关于生物等效性试验中血药峰浓度等效界值的思考

    Institute of Scientific and Technical Information of China (English)

    赵明; 谢松梅; 杨劲; 魏敏吉

    2014-01-01

    During the assessment of bioequivalence in our country ,the in-terval limits for maximum concentration ( Cmax ) is in an alternating phase.The aim of this paper is to introduce some principles and thoughts of bioequivalence for area under the curve (AUC) and Cmax.Examples of two drugs evaluation were presented here , which might be helpful for the development and review of generics.%在国内的生物等效性评价中,峰浓度(Cmax )的等效界值尚处在新老标准交替阶段。当 Cmax处在新老标准之间,如何进行审评决策,是一个需要认真考虑的问题。本文通过2个药物审评实例,介绍关于该类问题的思考原则和思路,以期为仿制药的研究开发和审评提供参考。

  18. 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.

  19. 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.

  20. Classification of Recommender Expertise in the Wikipedia Recommender System

    DEFF Research Database (Denmark)

    Jensen, Christian D.; Pilkauskas, Povilas; Lefevre, Thomas

    2011-01-01

    The Wikipedia is a web-based encyclopedia, written and edited collaboratively by Internet users. The Wikipedia has an extremely open editorial policy that allows anybody, to create or modify articles. This has promoted a broad and detailed coverage of subjects, but also introduced problems relati...... and present 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....... 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...... articles in the Wikipedia. In this paper, we examine different ways to classify the subject area of Wikipedia article according to well established knowledge classification schemes. We identify a number of requirements that a classification scheme must meet in order to be useful in the context of the WRS...

  1. Classification of Recommender Expertise in the Wikipedia Recommender System

    DEFF Research Database (Denmark)

    Jensen, Christian D.; Pilkauskas, Povilas; Lefévre, Thomas

    2011-01-01

    The Wikipedia is a web-based encyclopedia, written and edited collaboratively by Internet users. The Wikipedia has an extremely open editorial policy that allows anybody, to create or modify articles. This has promoted a broad and detailed coverage of subjects, but also introduced problems relati...... and present 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....... 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...... articles in the Wikipedia. In this paper, we examine different ways to classify the subject area of Wikipedia article according to well established knowledge classification schemes. We identify a number of requirements that a classification scheme must meet in order to be useful in the context of the WRS...

  2. Research of intelligent recommendation for mobile reading

    Science.gov (United States)

    Li, Qu

    2013-07-01

    Mobile reading is the trend of current publishing industry. Intelligent Recommendation system is useful and profitable for mobile reading platforms. Currently, intelligent recommendation systems mainly focus on news recommendation or production recommendation in e-commerce. In this paper, we designed and implemented an intelligent recommendation system based on slope one algorithm. Results show that our algorithm can help the users to find their interested books and thus greatly improve the income of mobile reading platform.

  3. [Comparative studies of paclitaxel injection "SAWAI" and Taxol® Injection on pharmacokinetics in dogs and in vitro/vivo antitumor activities].

    Science.gov (United States)

    Takahashi, Masato; Hosoda, Mitsuchika; Takahashi, Hiromasa; Todo, Satoru

    2010-09-01

    We performed bioequivalent assessments of the generic (Paclitaxel Injection "SAWAI") and branded (Taxol Injection) formulations of paclitaxel injection on pharmacokinetics in dogs and in vitro/vivo antitumor activities. In the pharmacokinetics study in dogs, the 90% confidence intervals (CIs) for the differences in logarithm of C(max) and AUC(0-48) were log (1.01) to log (1.17) and log (1.01) to log (1.08), respectively. These were within the bioequivalent criteria of log (0.80) to log (1.25). In the in vitro study, both products showed concentration-dependent inhibition of the growth of 5 cultured human cancer cell lines, MCF7 (breast adenocarcinoma), A2780 (ovarian carcinoma), A549 (lung carcinoma), MKN45 (gastric adenocarcinoma) and MKN74 (gastric adenocarcinoma). The 90% CIs for the differences in logarithm of half maximal inhibitory concentration (IC(50)) were log (0.876) to log (1.110), log (0.856) to log (1.097), log (0.977) to log (1.167), log (0.879) to log (1.093) and log (0.936) to log (1.081), respectively. These were within the bioequivalent criteria. In the in vivo study, both products showed concentration-dependent inhibition of the growth of 3 human cancer cells, A2780 (ovarian carcinoma), A549 (lung carcinoma) and MDA-MB-231 (breast adenocarcinoma), xenografted in nude mice. And there are no significant differences between Paclitaxel Injection "SAWAI" and Taxol Injection. These results showed that Paclitaxel Injection "SAWAI" is bioequivalent to Taxol Injection.

  4. [Nutrition recommendations for children who practice sports].

    Science.gov (United States)

    Sánchez-Valverde Visus, F; Moráis López, A; Ibáñez, J; Dalmau Serra, J

    2014-08-01

    Several health benefits have been attributed to sports practice, and an adequate nutrition status helps to maintain an optimal performance. Children most frequently practice non-competitive and non-endurance activities in a school setting. The dietary intake of children who practice sports should be similar to the general population, properly meeting their energy and nutrient requirements. During the activity performance, correct hydration should be aimed for, with water appearing to be an adequate source in most cases. General calorie and micronutrient supplementation should not be commonly recommended in children. Paediatricians must control nutritional status and dietary habits of children who practice sports, especially in those cases when weight-loss is aimed for, as well as take into account the psychological implications of competitive sports practice.

  5. Physical Exercise and MS Recommendations

    DEFF Research Database (Denmark)

    Dalgas, U; Ingemann-Hansen, T; Stenager, E

    2009-01-01

    in a number of physiological functions, which ultimately can lead to functional improvements that have a positive effect on a patients daily life. The purpose of this review is, based on the existing research, to provide clinicians with some easily administrable recommendations for the application of exercise......The use of physical exercise programmes in the rehabilitation of patients with multiple sclerosis (MS) has been a controversial issue for many years. During the last decade, however, evidence from a number of studies has suggested that exercise is a safe and efficient way to induce improvements...

  6. ExpertFOAF recommends experts

    DEFF Research Database (Denmark)

    Iofcu, Tereza; Diederich, Joerg; Dolog, Peter;

    2007-01-01

    the GrowBag approach [1]. The main assumption is that such user profiles can provide good hints about users' expertise. Such extended FOAF files (called ExpertFOAF) can be published on a user's home page, on web pages of institutions or conferences to characterize them. They can be crawled by distributed...... recommender systems for finding users with similar interests and, hence, expertise in different domains. We consider a well-defined user profile to express best the user's current interests in a domain, where the domain (such as the research environment with students and professors) is defined by a collection...

  7. WRS: The Wikipedia Recommender System

    Science.gov (United States)

    Lefévre, Thomas; Jensen, Christian Damsgaard; Korsgaard, Thomas Rune

    In 2005, the Wikipedia became the most popular reference website on the Internet and it has continued to grow in size and popularity ever since. With the increasing reliance on the Wikipedia comes issues of the credibility and provenance of content. In order to address these issues, we have developed a Recommender System for the Wikipedia, which allows the users of the Wikipedia to rate articles in order to guide other users about the quality of articles. This rating system provides both an incentive for authors to improve articles and a quantifiable measure of the perceived quality of articles.

  8. Dietetic recommendations in rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    María Rosa Alhambra-Expósito

    2013-12-01

    Full Text Available Rheumatoid arthritis (RA is a chronic autoimmune disease that has a significant effect on patients’ physical, emotional, and social functioning. For decades, patients have used different diets to try to improve the symptoms of RA. The possible benefits of dietary therapy for rheumatoid arthritis are reviewed in this article. Nutritional objectives for RA, are to halt the loss of bone mass, promote healing of bone fractures and improving bone-associated inflammatory disorders and joints. In general, diets low in saturated fat, rich in polyunsaturated fats: omega 3 and omega 6, rich in complex carbohydrates and fiber are recommended.

  9. Ontological Matchmaking in Recommender Systems

    CERN Document Server

    Bonifati, Angela; Sileo, Domenica; Summa, Gianvito

    2010-01-01

    The electronic marketplace offers great potential for the recommendation of supplies. In the so called recommender systems, it is crucial to apply matchmaking strategies that faithfully satisfy the predicates specified in the demand, and take into account as much as possible the user preferences. We focus on real-life ontology-driven matchmaking scenarios and identify a number of challenges, being inspired by such scenarios. A key challenge is that of presenting the results to the users in an understandable and clear-cut fashion in order to facilitate the analysis of the results. Indeed, such scenarios evoke the opportunity to rank and group the results according to specific criteria. A further challenge consists of presenting the results to the user in an asynchronous fashion, i.e. the 'push' mode, along with the 'pull' mode, in which the user explicitly issues a query, and displays the results. Moreover, an important issue to consider in real-life cases is the possibility of submitting a query to multiple p...

  10. Personalized Social Recommendations - Accurate or Private?

    CERN Document Server

    Machanavajjhala, Ashwin; Sarma, Atish Das

    2011-01-01

    With the recent surge of social networks like Facebook, new forms of recommendations have become possible - personalized recommendations of ads, content, and even new friend and product connections based on one's social interactions. Since recommendations may use sensitive social information, it is speculated that these recommendations are associated with privacy risks. The main contribution of this work is in formalizing these expected trade-offs between the accuracy and privacy of personalized social recommendations. In this paper, we study whether "social recommendations", or recommendations that are solely based on a user's social network, can be made without disclosing sensitive links in the social graph. More precisely, we quantify the loss in utility when existing recommendation algorithms are modified to satisfy a strong notion of privacy, called differential privacy. We prove lower bounds on the minimum loss in utility for any recommendation algorithm that is differentially private. We adapt two priv...

  11. Liquid Chromatography Tandem mass spectrometry method for Quantification of Buproprion and Hydroxy Buproprion in Human Plasma and its application to Bioequivalence Study

    Directory of Open Access Journals (Sweden)

    Peeyush Jain

    2012-06-01

    Full Text Available A rapid, specific and robust assay based on solid phase extraction and liquid chromatography-electronspray ionization tandem mass spectrometry (LC-ESI MS-MS has been developed and validated for the quantitative analysis of Buproprion (a drug used for smoking cessation in human plasma using Buproprion D9 as internal standard (ISTD. The precursors to product ion transitions of m/z 240.20/183.90 and m/z 256.10/237.90 were used to measure the analyte (Buproprion and hydroxy Buproprion and the precursor to product ion transition of m/z 249.20/131.00 was used to measure the ISTD. The method was validated over a concentration range of 1.00ng mL-1 to 304.65ng mL-1 for Bupropion and 3.00ng mL-1 to 801.78ng mL-1 for hydroxy Bupropion. The method was validated over the various parameters like selectivity, matrix effect, sensitivity, linearity, precision, accuracy, stabilities (bench-top stability, standard stock solution stability in refrigerator and at room temperature, stock dilution stability, auto-sampler stability, freeze thaw stability, long-term stability at -65°C ± 10°C & -22°C ± 5°C, reagent stability, dry-extract stability, wet-extract stability and blood stability, effect of potentially interfering drugs, dilution integrity, recovery, reinjection reproducibility, ruggedness, extended batch verification, ion-suppression through infusion and inter-conversion check etc. The mean percent recovery of Bupropion was found 58.443% with a precision of 1.01% whereas the mean percent recoveries of hydroxy Bupropion and Bupropion D9 were found 62.327% and 66.513% with a precision of 2.99% and 3.91% respectively. The RSD percent of intra-day and inter-day assay was ;15%. The application of this assay was demonstrated in a bioequivalence study and it was found suitable for a study of sample size as big as sixty enrolled volunteers.

  12. Recommendations for Insulin Dose Calculator Risk Management

    Science.gov (United States)

    2014-01-01

    Several studies have shown the usefulness of an automated insulin dose bolus advisor (BA) in achieving improved glycemic control for insulin-using diabetes patients. Although regulatory agencies have approved several BAs over the past decades, these devices are not standardized in their approach to dosage calculation and include many features that may introduce risk to patients. Moreover, there is no single standard of care for diabetes worldwide and no guidance documents for BAs, specifically. Given the emerging and more stringent regulations on software used in medical devices, the approval process is becoming more difficult for manufacturers to navigate, with some manufacturers opting to remove BAs from their products altogether. A comprehensive literature search was performed, including publications discussing: diabetes BA use and benefit, infusion pump safety and regulation, regulatory submissions, novel BAs, and recommendations for regulation and risk management of BAs. Also included were country-specific and international guidance documents for medical device, infusion pump, medical software, and mobile medical application risk management and regulation. No definitive worldwide guidance exists regarding risk management requirements for BAs, specifically. However, local and international guidance documents for medical devices, infusion pumps, and medical device software offer guidance that can be applied to this technology. In addition, risk management exercises that are algorithm-specific can help prepare manufacturers for regulatory submissions. This article discusses key issues relevant to BA use and safety, and recommends risk management activities incorporating current research and guidance. PMID:24876550

  13. Travel Recommendations for the Nursing Mother

    Science.gov (United States)

    ... Address What's this? Submit What's this? Submit Button Breastfeeding Information for Families Breastfeeding Hotline The HHS Office ... State and Local Programs Travel Recommendations for the Nursing Mother Recommend on Facebook Tweet Share Compartir Travel ...

  14. A Survey Paper on Recommender Systems

    CERN Document Server

    Almazro, Dhoha; Albdulkarim, Lamia; Kherees, Mona; Martinez, Romy; Nzoukou, William

    2010-01-01

    Recommender systems apply data mining techniques and prediction algorithms to predict users' interest on information, products and services among the tremendous amount of available items. The vast growth of information on the Internet as well as number of visitors to websites add some key challenges to recommender systems. These are: producing accurate recommendation, handling many recommendations efficiently and coping with the vast growth of number of participants in the system. Therefore, new recommender system technologies are needed that can quickly produce high quality recommendations even for huge data sets. To address these issues we have explored several collaborative filtering techniques such as the item based approach, which identify relationship between items and indirectly compute recommendations for users based on these relationships. The user based approach was also studied, it identifies relationships between users of similar tastes and computes recommendations based on these relationships. In...

  15. Back Bay Wilderness study : Proposed recommendations

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This document is a list of recommendations for the proposed wilderness area on the Back Bay National Wildlife Refuge. The recommendations come as a result of the...

  16. Treatment of psoriatic arthritis: management recommendations.

    Science.gov (United States)

    Gossec, Laure; Smolen, Josef S

    2015-01-01

    Given the varied therapeutic options available for the management of psoriatic arthritis (PsA), recommendations for the management of PsA have been developed by several expert groups. These recommendations deal mainly with pharmacological treatments. At the international level, 2 recommendations sets are available: these have been developed by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and by the European League against Rheumatism (EULAR). These recommendations were published in 2009 and in 2012, respectively; and updates of these recommendations are currently ongoing. The first sets of recommendations dealt with non-steroidal anti-inflammatory drugs, glucocorticoids, conventional synthetic disease modifying drugs and tumour necrosis factor inhibitors; the 2015 sets of recommendations also deal with new drugs with other mechanisms of action, namely ustekinumab, secukinumab and apremilast. In the present paper, we will review these management recommendations.

  17. Bioequivalence of Sodium Ferulate Capsules and Tablets in healthy volunteers%阿魏酸钠胶囊与片剂在健康人体的生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    杨婷; 余斌; 宋欣; 刘丽萍

    2011-01-01

    Objective: To study the pharmacokinetic characteristics of Sodium Ferulate Capsules and Tablets in healthy volunteers and to evaluate the bioequivalence of them. Methods: In a randomized, crossover and self-control study, 20 healthy volunteers were orally administrated Sodium Ferulate Capsules and Tablets (100 mg respectively). The plasma concentrations were determined by the HPLC-LJV. Pharmacokinetic parmeters were calculated and the bioequivalences were evaluated by DAS2.1 software. Results: The main pharmacokinetic parameters of Sodium Ferulate were as follows: Cmax (1.021±0.286)μg/ml and (1.066±0.397)μg/ml, tmax(0.388±0.078) h and (0.371±0.083) h, t1/2(0.887±0.431) h and (0.824± 0.404) h, AUC(0-1) (0.613±0.172) μg-h/ml and (0.614±0.235) μg-h/ml. Conclusion: The test and reference sodium ferulate are bioequivalent.%目的:研究阿魏酸钠胶囊和阿魏酸钠片在健康志愿受试者中的药动学和人体生物等效性.方法:20名健康志愿者随机交叉单次口服受试制剂阿魏酸钠胶囊和参比制剂阿魏酸钠片,均100 mg,采用HPLC-UV检测方法,测定血浆中阿魏酸钠浓度,采用Das2.1程序计算其药动学参数,评价两种制剂的人体生物等效性.结果:受试制剂及参比制剂主要药动学参数分别为:Cmax(1.021±0.286) μg/ml和(1.066±0.397) μg/ml,tmax(0.388±0.078) h和(0.371±0.083) h,t1/2(0.887±0.431) h和(0.824±0.404) h,AUC(0~t)(0.613±0.172) μg·h/ml和(0.614±0.235) μg·h/ml.结论:受试制剂阿魏酸钠胶囊和参比制剂阿魏酸钠片具有生物等效性.

  18. 吡拉西坦片健康人体药动学和生物等效性研究%Pharmacokinetics and bioequivalence of piracetam tablets in healthy volunteers

    Institute of Scientific and Technical Information of China (English)

    张志涛; 霍强; 赵怀清

    2006-01-01

    AIM: To study the bioequivalence of piracetam tablets in Chinese healthy volunteers. METH-ODS: Twenty volunteers were randomly divided into two groups (test and reference), with double cross-over design and single-dose oral administration. The concentration of piracetam in serum was determined by HPLC. The main pharmacokinetic parameters were calculated and the bioequivalence was evaluated with DAS2.0 practical pharmacokinetics program. RESULTS: The pharmacokinetic parameters of piracetam tablets were as follows: t1/2 were 5.50±1.48 and 4.29±1.00 h, Cmax were 21.47± 6.27 and 20.96±5.10 mg·L-1, Tmax were 0.70±0.46 and 0.66± 0.36 h, AUC0-24h were 93.44± 16.61 and 96.67± 18.50 mg·h·L- 1. The relative bioavailability of the test preparation was 99.8%± 22.7%. CONCLU-SION: The test and reference preparations were bioequivalent and may be prescribed interchangeably.%目的:研究两种吡拉西坦片在健康中国人体的生物等效性.方法:20名健康志愿者随机分为试验组和对照组,采用双交叉设计和单剂量口服方式,HPLC法测定血清中吡拉西坦浓度.经DAS2.0统计软件处理,计算主要药代动力学参数,并进行两种片剂的生物等效性评价.结果:两种吡拉西坦片剂的t1/2为5.50±1.48、4.29±1.00h,Cmax为21.47±6.27、20.96±5.10mg·L-1,Tmax为O.70±0.46、0.66±0.36 h,AUC0-24h为93.44±16.61、96.67±18.50 mg·h·L-1.受试制剂的相对生物利用度为99.8%±22.7%.结论:两种吡拉西坦片剂具有生物等效性.

  19. Assessment of bioequivalence of citalopram in healthy Chinese subjects by population pharmacokinetic model%群体药动学模型估算我国健康男性西酞普兰生物等效性

    Institute of Scientific and Technical Information of China (English)

    徐懿萍; 孙菁; 陈冰; 江涛; 陈红专

    2011-01-01

    Objective To establish a population pharmacokinetic (PPK) model of citalopram (CIT) in healthy man Chinese subjects, and to compare the bioequivalence of CIT estimated by PPK with that estimated by non-compartmental (NCA) model. Methods Blood samples of 23 healthy subjects were collected after CIT was given, and samples were analyzed using liquid chromatography-mass spectrometry. The PPK model of CIT was evaluated by nonlinear mixed-effect modeling (NONMEM). Bioequivalence of CIT was evaluated by both PPK and NCA method. Results The PPK model of CIT was consistent with one-compartment model. The estimated CIT clearance rate was (15.90±0.70) L/h and volume of distribution was (702.0±19.2) L. The CIT bioavailability estimated by NCA and PPK model was 90%, and the confidence intervals were 96.4%~105.4% and 92.5%~103.4%, respectively. Conclusions Bioequivalence of CIT could be estimated by NONMEM model.%目的:建立我国健康男性志愿者服用西酞普兰(CIT)的群体药动学(PPK)模型,并比较PPK模型与非房室(NCA)模型法估算CIT生物等效性的价值.方法:23名健康男性志愿者服用CIT后采集0~144 h血标本,采用高效液相色谱-电喷雾串联质谱法分析血浆中的CIT浓度,采用非线性混合效应模型(NONMEM)法评估CIT的PPK模型,并用NAC模型法和PPK模型法评价CIT的生物等效性.结果:CIT的PPK模型符合一房室模型,估算的CIT清除率和分布容积分别为(15.90±0.70)L/h和(702.0±19.2) L.采用NCA和PPK模型估算的CIT相对生物利用度90%可信区间分别为96.4%~105.4%和92.5%~103.4%,达到生物等效性的标准.结论:NONMEM法可用于评价CIT的生物等效性.

  20. Personalized recommendation against crowd's popular selection

    CERN Document Server

    Zhu, Xuzhen; Liu, Haifeng

    2014-01-01

    The problem of personalized recommendation in an ocean of data attracts more and more attention recently. Most traditional researches ignore the popularity of the recommended object, which resulting in low personality and accuracy. In this Letter, we proposed a personalized recommendation method based on weighted object network, punishing the recommended object that is the crowd's popular selection, namely, Anti-popularity index(AP), which can give enhanced personality, accuracy and diversity in contrast to mainstream baselines with a low computational complexity.

  1. TWIN: Personality-based Intelligent Recommender System

    OpenAIRE

    Roshchina, Alexandra; Cardiff, John; Rosso, Paolo

    2015-01-01

    This paper presents the Tell me What I Need (TWIN) Personality-based Intelligent Recommender System, the goal of which is to recommend items chosen by like-minded (or twin ) people with similar personality types which we estimate from their writings. In order to produce recommendations it applies the results achieved in the personality from the text recognition research field to Personality-based Recommender System user profile modelling. In this way it creates a bridge between the efforts...

  2. Paired analyst recommendations and internet IPOs

    NARCIS (Netherlands)

    T. van der Goot; N. van Giersbergen

    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.

  3. Cryptographically-enhanced privacy for recommender systems

    NARCIS (Netherlands)

    Jeckmans, Adrianus Johannus Paulus

    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 re

  4. Panorama of Recommender Systems to Support Learning

    NARCIS (Netherlands)

    Drachsler, Hendrik; Verbert, Katrien; Santos, Olga C.; Manouselis, Nikos

    2015-01-01

    This chapter presents an analysis of recommender systems in TechnologyEnhanced Learning along their 15 years existence (2000-2014). All recommender systems considered for the review aim to support educational stakeholders by personalising the learning process. In this meta-review 82 recommender syst

  5. FAVL work group: report and recommendations

    International Nuclear Information System (INIS)

    This document reports the works of a work group dedicated to the process of search for storage site for low activity and long life radioactive wastes. The authors recall the history of this process which started in the early 1990's, and resulted in the selection of two sites, in Auxon and in Pars-les-Chavanges, and finally in the withdrawal of both towns. Then, the authors analyse the whole process in terms of intervention or participation of local authorities, of information and participation of waste producers. They also discuss the roles of the ASN, IRSN, DGEC, ANDRA and ANDRA's Coesdic. They make recommendations regarding site selection, agenda, responsibilities, preferential representative at the local level, public information, consultation, and project support

  6. Memoire : Public consultation on off road vehicles: Recommendations for reducing pollution and greenhouse gases associated with off road vehicle activities in Quebec; Memoire : Consultation publique sur les vehicules hors route : Recommandations pour la reduction de la pollution et des gaz a effet de serre lies aux activites de vehicules hors route au Quebec

    Energy Technology Data Exchange (ETDEWEB)

    Belisle, A.; Castonguay, M. [Association quebecoise de lutte contre la pollution atmospherique, Saint-Leon-de-Standon, Quebec (Canada)

    2005-06-01

    Recreational or off-road vehicles (ORV) such as snowmobiles, cross-country vehicles and dirt bikes emit significant levels of exhaust gases, thus contributing to air pollution. The Association quebecoise de lutte contre la pollution atmospherique (AQLPA) has prepared a memoire that recommends several means of reducing air pollution emissions generated by ORVs. The memoire discusses measures such as more rigorous regulations regarding the allowed power of the engines; obligations by manufacturers to resort to anti pollution measures; the imposition of strict standards on pollutant emissions; as well as a policy that respects the rights of people and the environment regarding the use and installation of paths for ORVs. Other recommendations include equipping the vehicles with a catalytic converter; obligatory inspection of ORVs; creating a program of re-naturalization near ORV paths; and promoting alternative activities whose practices do not generate greenhouse gases and which do not contribute to air pollution. 7 tabs., 2 apps.

  7. Interest-based Recommendation in Digital Library

    Directory of Open Access Journals (Sweden)

    Yan Yang

    2005-01-01

    Full Text Available With the huge amount and large variety of information available in a digital library, it’s becoming harder and harder for users to identify and get hold of their interested documents. To alleviate the difficulty, personalized recommendation techniques have been developed. Current recommendation techniques rely on similarity between documents. In our work, recommendations are made based on three factors: similarity between documents, information amount, and information novelty. With the introduction of degree of interest, users’ interests can be better characterized. Theoretical analysis and experimental evaluations demonstrate that our techniques can improve both the recommendation recall and recommendation precision.

  8. Epilepsy surgery: Recommendations for India

    Directory of Open Access Journals (Sweden)

    Chandra P

    2010-01-01

    Full Text Available The following article recommends guidelines for epilepsy surgery for India. This article reviews the indications, the various surgical options available and the outcome of surgery for drug resistant epilepsy based on current evidence. Epilepsy surgery is a well-established option for patients who have been diagnosed to have drug resistant epilepsy (DRE (on at least two appropriate, adequate anti-epileptic drugs (AEDs (either in monotherapy or in combination with continuing seizures, where the presurgical work-up has shown concordance of structural imaging (magnetic resonance imaging and electrical mapping data (electroencephalography (EEG, video EEG. There may be a requirement of functional imaging techniques in a certain number of DRE like positron emission tomography (PET, single photon emission tomography, (SPECT. Invasive monitoring should be restricted to a few when all noninvasive investigations are inconclusive, there is a dual pathology or there is a discordance of noninvasive data. The types of surgery could be curative (resective surgeries: amygdalo hippocampectomy, lesionectomy and multilobar resections; functional surgeries: hemispherotomy and palliative (multiple subpial transaction, corpus callosotomy, vagal nerve stimulation. Epilepsy surgery in indicated cases has a success range from 50 to 86% in achieving seizure freedom as compared with < 5% success rate with AEDs only in persons with DRE. Centers performing surgery should be categorized into Level I and Level II.

  9. Permian Basin location recommendation report

    International Nuclear Information System (INIS)

    Candidate study areas are screened from the Palo Duro and Dalhart Basin areas using data obtained from studies to date and criteria and specifications that consider: rock geometry; rock characteristics; human intrusion potential; surface characteristics; and environmental and socioeconomic conditions. Two preferred locations are recommended from among these areas for additional characterization to identify potential National Waste Terminal Storage (NWTS) salt repository sites. One location, in northeastern Deaf Smith County and southeastern Oldham County, is underlain by two salt units that meet the adopted screening specifications. The other location, in northcentral Swisher County, is underlain by one salt unit that meets the adopted screening specifications. Both locations have several favorable features, relative to surrounding areas, and no obviously undesirable characteristics. Both lie wholly on the Southern High Plains surface, are in relatively sparsely populated areas, contain no unique land use conflicts, and comprise large enough geographic areas to provide flexibility in site selection. Data gathered to date indicate that these locations contain salt units sufficient in thickness and in depth for the safe construction and operation of the underground facilities under consideration. 93 references, 34 figures, 6 tables

  10. Nutritional recommendations for synchronized swimming.

    Science.gov (United States)

    Robertson, Sherry; Benardot, Dan; Mountjoy, Margo

    2014-08-01

    The sport of synchronized swimming is unique, because it combines speed, power, and endurance with precise synchronized movements and high-risk acrobatic maneuvers. Athletes must train and compete while spending a great amount of time underwater, upside down, and without the luxury of easily available oxygen. This review assesses the scientific evidence with respect to the physiological demands, energy expenditure, and body composition in these athletes. The role of appropriate energy requirements and guidelines for carbohydrate, protein, fat, and micronutrients for elite synchronized swimmers are reviewed. Because of the aesthetic nature of the sport, which prioritizes leanness, the risks of energy and macronutrient deficiencies are of significant concern. Relative Energy Deficiency in Sport and disordered eating/eating disorders are also of concern for these female athletes. An approach to the healthy management of body composition in synchronized swimming is outlined. Synchronized swimmers should be encouraged to consume a well-balanced diet with sufficient energy to meet demands and to time the intake of carbohydrate, protein, and fat to optimize performance and body composition. Micronutrients of concern for this female athlete population include iron, calcium, and vitamin D. This article reviews the physiological demands of synchronized swimming and makes nutritional recommendations for recovery, training, and competition to help optimize athletic performance and to reduce risks for weight-related medical issues that are of particular concern for elite synchronized swimmers. PMID:24667278

  11. Problems and countermeasures in domestic human bioequivalence studies for the oral preparations containing omeprazole or its salt%国内奥美拉唑(盐)口服制剂人体生物等效性试验的问题和对策

    Institute of Scientific and Technical Information of China (English)

    王晓琳; 刘会臣

    2011-01-01

    Omeprazole is a representative drug of the proton pump inhibitors (PPIs), and has been applied widely in clinical therapy. Here, we summarized 26 domestic references of human bioequivalence researches for the oral preparations containing omeprazole or its salt. The problems and countermeasures referred to experiment contents, reference preparations, subjects, collection and analysis of biological samples, pharmacokinetic parameters, and post-marketing bioequivalence re-evaluation or monitoring were described and discussed. The goal is to provide useful reference information for human bioequivalence research and clinical application of omeprazole or its salt. Based on the current research situation, it is advisable to carry out food-effect bioequivalence studies, exclude poor metabolizers from subjects in bioequivalence studies, choose corresponding original drugs as reference preparations, standardize bioanalytical method validation, and perform post-marketing bioequivalence re-evaluation or monitoring.%奥美拉唑是质子泵抑制剂类代表药物,临床上应用广泛.文中通过对国内26篇奥美拉唑(盐)12服制剂人体生物等效性试验文献进行分析,探讨了试验内容、参比制剂、受试者、生物样品采集及分析、药动学参数、上市后生物等效性再评价或监测等方面的问题和对策,以期为奥美拉唑(盐)口服制剂人体生物等效性研究和临床应用提供参考信息,并基于现有研究状况提出以下建议:开展食物影响研究、在受试者筛选时排除弱代谢者、参比制剂选择相同剂型的原创药、规范分析测定方法的确证并开展和加强奥美拉唑(盐)口服制剂的上市后生物等效性再评价或监测.

  12. 国产盐酸托莫西汀胶囊在健康人体的生物等效性%Bioequivalence of atomoxetine hydrochloride in Chinese health volunteers

    Institute of Scientific and Technical Information of China (English)

    魏计超; 刘西哲; 于洋; 侯艳宁

    2015-01-01

    Objective To establish a method for determination of atomoxetine plasma concentration by HPLC-MS/MS and study the bioavailability and bioequivalence of atomoxetine capsule in Chinese health male volunteers. Methods A randomized,two periods,crossover bioequivalence trial was designed. 24 healthy volunteers were randomly divided into two groups,and they were given a single oral dose of the tested atomoxetine capsule and reference atomoxetine capsule 20mg re-spectively. The concentrations of atomoxetine in plasma were determined by a valid LC-MS/ MS method. The pharmacokinetic parameters and relative bioavailability were processed by DAS 2. 1. 1 program to evaluate the bioequivalence of test and refer-ence capsule. Results The pharmacokinetic parameters of the test and reference capsules were as follows:Cmax were(232. 5 ± 86. 9)and(222. 8 ± 101. 1)ng/ ml;tmax were(1. 17 ± 1. 14)and(1. 27 ± 1. 09)h;t1 / 2 were(3. 55 ± 1. 33)and(3. 38 ± 1. 20)h;AUC0 - t were(1610 ± 1329)and(1575 ± 1301)ng·ml - 1 ·h - 1;AUC0 - ∞ were(1683 ± 1466)and(1634 ± 1392)ng·ml - 1 ·h - 1 ,respectively. The relative bioavailability of the test capsules was(104. 9 ± 14. 3)% . Conclusion The two preparations were bioequivalence.%目的:建立人血浆中托莫西汀浓度的 HPLC-MS/ MS 测定方法,研究国产盐酸托莫西汀胶囊在中国健康男性志愿者的主要药动学参数及与参比制剂的生物等效性。方法采用两试剂双周期交叉试验设计,24名健康受试者分别单剂量口服受试制剂和参比制剂20mg,采用 LC-MS/ MS 法测定血浆中托莫西汀的浓度,DAS 2.1.1软件计算药动学参数并考察生物等效性。结果受试制剂和参比制剂在受试者体内的药动学参数如下:Cmax 分别为(232.5±86.9)和(222.8±101.1)ng/ ml;tmax 分别为(1.17±1.14)和(1.27±1.09)h;t1/2分别为(3.55±1.33)和(3.38±1.2)h;AUC0- t分别为(1610±1329)和(1575±1301)ng·ml -1·h -1;AUC0

  13. Bioequivalence of metformin hydrochloride tablets in Chinese healthy volunteers%盐酸二甲双胍片在中国健康人体的生物等效性

    Institute of Scientific and Technical Information of China (English)

    邱相君; 孙永健; 刘涛; 刘心霞; 袁世英; 陈汇

    2012-01-01

    Objective To evaluate the bioequivalence of two domestic metformin hydrochloride tablets in healthy volunteers. Methods A single oral dose (1. 0 g of test and reference formulation) was given to 20 healthy volunteers in a randomized crossover study. The concentrations of metformin hydrochloride in plasma were determined by HPLC. The bio-availability and bioequivalence of two formulations were evaluated by DAS 2. 0 software, then the bioequivalence was judged. Results After a single dose, the pharmacokinetic parameters for tested and reference metformin hydrochloride were as follows: Cmax were (2. 83 ± 0. 53 ), (2.57±0.57) mg , L-1; Twere (1.55 ±0. 39) , (t. 63 ±0. 36) h; t1/2 were ( 3. 70 + 1. 76), (3. 36 ± 0. 72) h; AUC0_24 were (10. 20 ± 1. 95), (9. 71 ± 2. 56) mg · h · L-1, respectively. The 90% confidential interval of AUC0-24, AUC0-∞ and Cmax of test formulation were 99. 1% -114.6% , 99. 1% -113. 8% and 100.6% -110.4% , respectively. The relative bioavailability of test to reference formulation was (108. 3 ± 20. 5 ) % . Conclusion The test and reference metformra hydrochloride were bioequivalence.%目的 评价2种国产盐酸二甲双胍片(口服降糖药)在中国健康人体的生物等效性.方法 20名健康男性受试者随机交叉单剂量口服盐酸二甲双胍片试验药物和对照药物,各1.0 g.用高效液相色谱法测定血浆中盐酸二甲双胍的浓度,用DAS 2.0软件计算药代动力学参数,并对2种药物进行生物等效性评价.结果 试验药物和对照药物的主要药代动力学参数如下:Cmax为(2.83±0.53),(2.57±0.57) mg· L-1;Tmax为(1.55±0.39),(1.63±0.36)h;t1/2为(3.70±1.76),(3.36±D.72) h;AUC0-24为(10.20±1.95),(9.71±2.56) mg·h·L-1.AUC0-24、AUC0-∞、Cmax的90%可信区间分别为99.1% ~114.6%、99.1% ~ 113.8%和100.6%~110.4%.试验药物相对于对照药物的生物利用度F为(108.3±20.5)%.结论 试验药物和对照药物生物等效.

  14. Hybrid recommendation methods in complex networks

    CERN Document Server

    Fiasconaro, A; Nicosia, V; Latora, V; Mantegna, R N

    2014-01-01

    We propose here two new 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 relevant data sets, and we compare their performance with several recommendation systems recently proposed in the literature. We show that the proposed similarity measures allow to attain an improvement of performances of up to 20\\% with respect to existing non-parametric 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 studied how an increasing presence of random links in the network affects the recommendation scores, and we found that one of the two recommendation algorithms introduced here can systematically outpe...

  15. Collaborative Filtering Based Recommendation System: A survey

    Directory of Open Access Journals (Sweden)

    Mohd Abdul Hameed

    2012-05-01

    Full Text Available the most common technique used for recommendations is collaborative filtering. Recommender systems based on collaborative filtering predict user preferences for products or services by learning pastuser-item relationships from a group of user who share the same preferences and taste. In this paper we have explored various aspects of collaborative filtering recommendation system. We have categorizedcollaborative filtering recommendation system and shown how the similarity is computed. The desired criteria for selection of data set are also listed. The measures used for evaluating the performance of collaborative filtering recommendation system are discussed along with the challenges faced by the recommendation system. Types of rating that can be collected from the user to rate items are alsodiscussed along with the uses of collaborative filtering recommendation system.

  16. ISFG: Recommendations on biostatistics in paternity testing

    DEFF Research Database (Denmark)

    Gjertson, David W; Brenner, Charles H; Baur, Max P;

    2007-01-01

    The Paternity Testing Commission (PTC) of the International Society for Forensic Genetics has taken up the task of establishing the biostatistical recommendations in accordance with the ISO 17025 standards and a previous set of ISFG recommendations specific to the genetic investigations in patern......The Paternity Testing Commission (PTC) of the International Society for Forensic Genetics has taken up the task of establishing the biostatistical recommendations in accordance with the ISO 17025 standards and a previous set of ISFG recommendations specific to the genetic investigations....../reconstruction and immigration cases), respectively. The fourth recommendation considers strategies regarding genetic evidence against paternity. The fifth recommendation covers necessary documentation, reporting details and assumptions underlying calculations. The PTC strongly suggests that these recommendations should...

  17. 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.

  18. 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.

  19. 盐酸乙哌立松片在健康人体内的药代动力学及生物等效性%Pharmacokinetics and bioequivalence of eperisone hydrochloride tablet in healthy subjects

    Institute of Scientific and Technical Information of China (English)

    魏欣; 丁黎; 高家敏; 李君; 张胜强; 沈建平; 张银娣

    2004-01-01

    Aim To develop a HPLC-ESI-MS assay for determination of eperisone hydrochloride in human plasma and investigate the pharmacokinetics and bioequivalence of two eperisone hydrochloride tablets in human. Methods Buflomedil hydrochloride was used as the internal standard. After alkalized with saturated sodium bicarbonate solution, plasma was extracted with diethylether-cyclohexane (1:1) and separated using HPLC on a reversed-phase C18 column with a mobile phase of 10mmol·L-1 ammonium acetate buffer solution (adjusted to pH 3.88 with acetic acid)-methanol (20:80). HPLC-ESI-MS was performed in the selected ion monitoring (SIM) mode using target ions at m/z 260 for eperisone and m/z 308 for the internal standard. A randomized crossover design was performed in 20 healthy volunteers. In the two study periods, a single 100mg dose of each tablet was administered to each volunteer. Results Calibration curve was linear over the range of 0.02-20μg·L-1. The limit of quantification for eperisone hydrochloride in plasma was 0.02μg·L-1. The main pharmacokinetics parameters T1/2, Tmax and Cmax were (2.7±0.4)h, (1.1±0.5)h and (2.8±2.8)μg·L-1 for the reference tablet; (2.8±0.5)h, (1.1±0.4)h and (3±4)μg·L-1 for the test tablet, respectively. The relative bioavalability of the test tablet was (101±13)%. Conclusion The assay was proved to be sensitive, accurate and convenient. The two formulations were bioequivalent.

  20. Quantitative determination and bioequivalence assessment of the drugs as endogenous compounds%内源性物质药物的定量测定及生物等效性评价研究进展

    Institute of Scientific and Technical Information of China (English)

    张煊; 谢小青; 刘婷立; 宋冬梅

    2011-01-01

    The quantitative determination of endogenous compounds in biological samples is more complicated and difficult in aspects of both analytical methods and the validation. The literature of the domestic and overseas was investigated, analyzed and summarized. In this paper, we reviewed in detail the quantitative determination methods of endogenous compounds in biological samples, study design and assessment of the bioequivalence of endogenous drugs. A number of different strategies had been employed to overcome the corresponding inherent bias. Considerations and methods are very meaningful to promote bioanalysis of the endogenous compounds and the evaluation of bioequivalence of endogenous drugs.%从定量分析和方法验证的角度来看,生物样品中内源性化合物的定量测定是非常复杂和困难的,而内源性药物的生物等效性评价同样也有其特殊性.文中通过对国内外文献资料进行调研、分析和总结,详细综述了内源性药物的生物分析方法及生物等效性试验设计和评价方法,并对面临的不同问题提出针对性解决方法.本文提供的一些思路和方法,对内源性药物的生物样品分析及生物等效性评价有重要意义.

  1. Quantification of 3α-hydroxytibolone in human plasma by high performance liquid chromatography coupled to electrospray ionization tandem mass spectrometry (HPLC-ESI-MS/MS: Application in a bioequivalence study in healthy postmenopausal volunteers

    Directory of Open Access Journals (Sweden)

    Lucas Azevedo Portela

    2016-06-01

    Full Text Available A sensitive, specific and fast method to quantify 3α-hydroxytibolone in human plasma using deuterated 3α-hydroxytibolone (d5 as internal standard is described. The analyte and the internal standard were extracted from plasma (900 μL by liquid-liquid extraction using ethyl ether/hexane (50/50, v/v and ammonium hydroxide (50%. The extracts were analyzed by high performance liquid chromatography coupled to electrospray ionization tandem mass spectrometry without derivatization. Chromatography was performed isocratically on a Gemini-NX™ C18 5 μm (150 × 4.6 mm i. d. column. The method had a chromatographic run time of 3.75 min and a linear calibration curve over the range 1–100 ng/mL. The limit of quantification validated was 1 ng/mL. This method was used to assess the bioequivalence between two different tibolone oral formulations: Livolon (1.25 mg tablet provided by Biolab Sanus Farmacêutica (Brazil, as the test formulation, and Libiam™ (1.25 mg tablet produced by Libbs Farmacêutica (Brazil, as the reference formulation. A single 3.75 mg dose of each formulation was administered to 46 postmenopausal female healthy volunteers. The study was conducted in an open, randomized, two-period crossover balanced design with a 2 week washout interval between the doses. The 90% confidence interval for Cmax, AUC(0-last and AUC(0-inf individual test/reference ratios were 97.48–111.51, 95.35–103.20 and 96.42–103.86, respectively. It is concluded that Livolon (1.25 mg tablet is bioequivalent to Libiam™ (1.25 mg tablet, with regards to both rate and extent of absorption.

  2. 盐酸文拉法辛胶囊在健康人体内的药动学和生物等效性%Pharmacokinetics and Bioequivalence of Venlafaxine Hydrochloride Capsules in Healthy Volunteers

    Institute of Scientific and Technical Information of China (English)

    王蒙; 华雯妍; 张全英

    2009-01-01

    A LC-MS/MS method was established for the determination of venlafaxine in human plasma. According to a randomized two-period crossover design, the pharmacokinetics and bioequivalence after single dose oral administration of test and reference capsules in 24 healthy volunteers were investigated. The pharmacokinetic parameters of test and reference capsules were as follows: c_(max) (71.1±29.9) and (71.2±26.6) ng/ml, t_(max) (2.31±0.67) and (2.31± relative bioavailability of the preparation was (101.8±18.3) %. The two formulations are bioequivalent.%建立了LC-MS/MS法测定人血浆中的文拉法辛,研究了24例男性健康受试者双周期、交叉、随机、单剂量口服盐酸文拉法辛胶囊50 mg后的药动学和相对生物利用度.受试与参比制剂的主要药动学参数分别为:c_(max)(71.1±29.9)和(71.2±26.6)ng/m1.t_(max)(2.31±0.67)和(2.31±0.75)h:t_(1/2)(4.68±1.30)和(4.83±1.39)h;AUC_(0→24)(534.7±334.6)和(543.9±370.3)h·ng·ml~(-1),相对生物利用度为(101.8±18.3)%,两种制剂具有生物等效性.

  3. Comprehensive Categorization of Guideline Recommendations: Creating an Action Palette for Implementers

    OpenAIRE

    Essaihi, Abdelwaheb; Michel, George; Shiffman, Richard N.

    2003-01-01

    Transforming guideline recommendations into executable statements for computerized decision support systems requires a clear understanding of what tasks must be performed. We sought (a) to determine whether a limited set of action types could be defined to comprehensively categorize activities recommended by the majority of clinical guidelines, (b) to describe the relative frequency of these action types, and (c) to create a library of recommendations for future validation activities. We rand...

  4. NUTRITION FOR TENNIS: PRACTICAL RECOMMENDATIONS

    Directory of Open Access Journals (Sweden)

    Mayur K. Ranchordas

    2013-06-01

    Full Text Available Tennis is a pan-global sport that is played year-round in both hemispheres. This places notable demands on the physical and psychological preparation of players and included in these demands are nutritional and fluid requirements both of training and match- play. Thus, the purpose of this article is to review nutritional recommendations for tennis. Notably, tennis players do not excel in any particular physiological or anthropometric characteristic but are well adapted in all areas which is probably a result of the varied nature of the training demands of tennis match play. Energy expenditures of 30.9 ± 5.5 and 45.3 ± 7.3 kJ·min-1 have been reported in women and men players respectively regardless of court surface. Tennis players should follow a habitually high carbohydrate diet of between 6-10 g·kg-1·d-1 to ensure adequate glycogen stores, with women generally requiring slightly less than men. Protein intake guidelines for tennis players training at a high intensity and duration on a daily basis should be ~1.6 g·kg-1·d-1 and dietary fat intake should not exceed 2 g·kg-1·d-1. Caffeine in doses of 3 mg·kg-1 provides ergogenic benefit when taken before and/or during tennis match play. Depending on environmental conditions, sweat rates of 0.5 to and over 5 L·hr-1 and sodium losses of 0.5 - 1.8 g have been recorded in men and women players. 200 mL of fluid containing electrolytes should be consumed every change-over in mild to moderate temperatures of 400 mL. 30-60 g·hr-1 of carbohydrate should be ingested when match play exceeds 2 hours.

  5. 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 in

  6. Consensus recommendations on training and competing in the heat

    DEFF Research Database (Denmark)

    Racinais, S; Alonso, J M; Coutts, A J;

    2015-01-01

    Exercising in the heat induces thermoregulatory and other physiological strain that can lead to impairments in endurance exercise capacity. The purpose of this consensus statement is to provide up-to-date recommendations to optimize performance during sporting activities undertaken in hot ambient...

  7. 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…

  8. Building Personalized and Non Personalized Recommendation Systems

    Directory of Open Access Journals (Sweden)

    SNEHA KHATWANI

    2016-07-01

    Full Text Available The contents of e-Commerce such as music, movies, books and electronics goods are necessary for a modern life style. But, it becomes difficult to find content according to users likes and users preference. An approach which produces desirable results to solve such the problem is to develop "Recommender System." The Recommender System of an e-Commerce site selects and suggests the contents to meet user's preference automatically using data sets of previous users stored in database. There can be two types of recommendations viz. Personalized and Non- Personalized recommendations. Personalized recommendation takes into consideration users’ previous history for rating and predicting items. On the other hand nonpersonalized recommendation systems recommend what is popular and relevant to all the users which can be a list of top-10 items for every new user. One of the most important techniques in the Recommender System is information filtering. The filtering techniques can be mainly classified into two categories viz. Collaborative Filtering and Content Based Filtering. Recommender system is a type of web intelligence technique that can make daily information filtering for users. This paper covers different techniques which can be used for creating personalized and non-personalized recommendations. This paper also explores the different packages of R i.e. Shiny which is used to create web applications and rmarkdown which is used to create dynamic documents.

  9. Substantial variability in postoperative treatment, and convalescence recommendations following vaginal repair. A nationwide questionnaire study

    DEFF Research Database (Denmark)

    Ottesen, Marianne; Møller, Charlotte; Kehlet, H;

    2001-01-01

    (range, 1-12), and the recommended time till recommencement of sexual intercourse was median 4 weeks (range, 0-12). The recommended convalescence was median 4-5 weeks for strenuous activities, and median 1-2 weeks for non-strenuous activities, with ranges from 0-24 weeks. The overall, great variance...... consensus are desirable....

  10. 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...... 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...... 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...

  11. 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...

  12. 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.

  13. Network-based recommendation algorithms: A review

    CERN Document Server

    Yu, Fei; Gillard, Sebastien; Medo, Matus

    2015-01-01

    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.

  14. Breeders’ work after cultivar development - the stage of recommendation

    Directory of Open Access Journals (Sweden)

    Luiz Carlos Federizzi

    2012-12-01

    Full Text Available The development of new cultivars is the ultimate goal of breeding programs and is the result of many years of hard work and dedication of breeders and their teams. An important part of the process, often neglected by geneticists, is the stage from recommendation to the production of breeder seed (post-breeding. This paper discusses the role of the breeder in the recommendation, registration, protection and marketing of new cultivars. The breeder’s active participation in all phases of post-breeding is fundamental to ensure that the cultivar reaches farmers quickly and can provide the benefits expected by society

  15. Consistence beats causality in recommender systems

    OpenAIRE

    Zhu, Xuzhen; Tian, Hui; Hu, Zheng; Zhang, Ping; Zhou, Tao

    2015-01-01

    The explosive growth of information challenges people's capability in finding out items fitting to their own interests. Recommender systems provide an efficient solution by automatically push possibly relevant items to users according to their past preferences. Recommendation algorithms usually embody the causality from what having been collected to what should be recommended. In this article, we argue that in many cases, a user's interests are stable, and thus the previous and future prefere...

  16. BROND: USSR recommended evaluated neutron data library

    International Nuclear Information System (INIS)

    BROND is the recommended evaluated data library of the USSR for neutron induced nuclear reactions. It is a computer library recorded on magnetic tape presented in the internationally recommended format ENDF-5. It contains 65 files with recommended data for 65 elements or isotopes. For each file the present report gives a summary documentation on the contents, the evaluation methods and the originators of the files. (author). Refs

  17. Recommendation advertising method based on behavior retargeting

    Science.gov (United States)

    Zhao, Yao; YIN, Xin-Chun; CHEN, Zhi-Min

    2011-10-01

    Online advertising has become an important business in e-commerce. Ad recommended algorithms are the most critical part in recommendation systems. We propose a recommendation advertising method based on behavior retargeting which can avoid leakage click of advertising due to objective reasons and can observe the changes of the user's interest in time. Experiments show that our new method can have a significant effect and can be further to apply to online system.

  18. Web Page Recommendation Using Web Mining

    Directory of Open Access Journals (Sweden)

    Modraj Bhavsar

    2014-07-01

    Full Text Available On World Wide Web various kind of content are generated in huge amount, so to give relevant result to user web recommendation become important part of web application. On web different kind of web recommendation are made available to user every day that includes Image, Video, Audio, query suggestion and web page. In this paper we are aiming at providing framework for web page recommendation. 1 First we describe the basics of web mining, types of web mining. 2 Details of each web mining technique.3We propose the architecture for the personalized web page recommendation.

  19. The discussion on several key questions in human bioequivalence study of oral preparation of terazosin hydrochloride%对盐酸特拉唑嗪口服制剂人体生物等效性试验几个关键问题的探讨

    Institute of Scientific and Technical Information of China (English)

    强桂芬; 杨漫; 张娅喃; 刘曼; 张丹; 刘会臣

    2011-01-01

    Generic drug, as the main variety researched and developed in China, needs to be validated by the human bioequivalence study before marketing. The quality of human bioequivalence study relates to the quality of numerous drugs, therefore influences drug safety and efficacy for the great majority of people. We summarized some methods of work and experience in the human bioequivalence study of oral preparation of terazosin hydrochlo-ride. In this paper, we discuss several key issues including study design, test preparation and reference preparation , selection and number of subjects, clinical monitoring, and the collection, treatment and detection of biological samples. We want to supply constructive suggestions for the normalization and higher quality of human bioequivalence study in the future.%我国的药品研究开发以仿制药为主,仿制药上市前通常需要进行人体生物等效性试验.人体生物等效性试验的质量直接关系到众多药品的质量,进而影响到广大人民群众的用药安全和疗效.作者在完成盐酸特拉唑嗪口服制剂人体生物等效性试验中总结了一些做法和体会,通过探讨试验设计、受试制剂和参比制剂、受试者选择和例数、临床监护、生物样品采集、处理和检测等几个关键问题,旨在为今后人体生物等效性试验的规范化和质量提高提供一些建设性意见.

  20. CONTEXTUAL MODEL OF RECOMMENDING RESOURCES ON AN ACADEMIC NETWORKING PORTAL

    Directory of Open Access Journals (Sweden)

    Anoop Kumar Pandey

    2013-02-01

    Full Text Available Artificial Intelligence techniques have been instrumental in helping users to handle the large amount of information on the Internet. The idea of recommendation systems, custom search engines, and intelligent software has been widely accepted among users who seek assistance in searching, sorting, classifying, filtering and sharing this vast quantity of information. In this paper, we present a contextual model of recommendation engine which keeping in mind the context and activities of a user, recommends resources in an academic networking portal. The proposed method uses the implicit method of feedback and the concepts relationship hierarchy to determine the similarity between a user and the resources in the portal. The proposed algorithm has been tested on an academic networking portal and the results are convincing.

  1. 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

  2. DEVELOPMENT OF A GENERIC RECOMMENDER SYSTEM

    Directory of Open Access Journals (Sweden)

    Dan Munteanu

    2004-12-01

    Full Text Available his paper presents a recommender system for textual documents taken from web (given as bookmarks. The system uses for classification a combination of content, event and collaborative filters and for recommendation a modified Pearson-r algorithm. It uses implicit and explicit feedback for evaluating documents.

  3. Vitamin D recommendations for older adults

    Science.gov (United States)

    This position paper of the International Osteoporosis Foundation makes recommendations for vitamin D nutrition in elderly men and women from an evidence-based perspective. The key recommendations are that the optimal level of 25-hydroxyvitamin D for musculoskeletal health is 75 nmol/L. An intake of ...

  4. The seniorgezond recommender: exploration put into practice

    NARCIS (Netherlands)

    Hollink, V.; Someren, M. van; Hagen, S. ten; Hilgersom, M.J.C.; Rovekamp, T.J.M.

    2007-01-01

    Recommender systems suggest objects to users navigating a web site. They observe the pages that a user visits and predict which other pages may be of interest. On the basis of these predictions recommenders select a number of pages that are suggested to the user. By far the most popular recommendati

  5. A Personalized Word of Mouth Recommender Model

    Directory of Open Access Journals (Sweden)

    Chihli Hung

    2008-09-01

    Full Text Available Word of mouth (WOM has a powerful effect on consumer behavior. Manually collecting WOM is very time-consuming in the era of the Internet. An automatic WOM recommender model is useful for both marketers and consumers. There are many different product features and thus many consumer choices. Each individual consumer has different preferences and these preferences may be changed deliberately or unwittingly. However, most existing WOM recommender models do not adapt to user preferences. This study proposes a conceptual WOM recommender model, which contains WOM collecting, document processing, recommending and user preference processing phases. More specifically, the self-organizing map (SOM is used to store and abstract user preferences. This proposed WOM model makes recommendations to consumers or users according to their adaptive preferences.

  6. Semantic Grounding Strategies for Tagbased Recommender Systems

    CERN Document Server

    Durao, Frederico

    2011-01-01

    Recommender systems usually operate on similarities between recommended items or users. Tag based recommender systems utilize similarities on tags. The tags are however mostly free user entered phrases. Therefore, similarities computed without their semantic groundings might lead to less relevant recommendations. In this paper, we study a semantic grounding used for tag similarity calculus. We show a comprehensive analysis of semantic grounding given by 20 ontologies from different domains. The study besides other things reveals that currently available OWL ontologies are very narrow and the percentage of the similarity expansions is rather small. WordNet scores slightly better as it is broader but not much as it does not support several semantic relationships. Furthermore, the study reveals that even with such number of expansions, the recommendations change considerably.

  7. Bioequivalence assessment of amoxicillin by limited sampling strategy in Chinese healthy volunteers%LSS法估算中国健康志愿者口服阿莫西林的生物等效性

    Institute of Scientific and Technical Information of China (English)

    陈丽芳; 焦建杰; 张才丽; 娄建石

    2012-01-01

    Objective To develop limited sampling strategy ( LSS) for estimating bioequivalence of amoxicillin. Methods Twenty male healthy subjects were enrolled in this bioequivalence study. All subjects were divided into two groups randomly and administered orally reference and test formulation of 500 mg amoxicillin. The blood concentrations of amoxicillin were determined by the validated HPLC method. A multiple linear regression analysis was developed for estimating Cmax and AUC0_t using the amoxicillin concentration of the reference formulation to develop LSS models. The LSS models were internally validated by the Jackknife meth od. The models were also externally validated by bioequivalence assessment of the test amoxicillin formulation based on LSS derived Cmax and AUC0-t values, The results were compared with those obtained using traditional method. Results The results indicate: several models for these parameters estimation met the predefined criteria. Validation tests indicated that most informative sampling points C1, C3 and C1 ,C2,C4 provided accurate estimations of the parameters AUC0-1, ( prediction error < 1% , absolute percentage < 10% ) ,And C1 ,C1.5 and C1.5 ,C2,C6 provided accurate estimations of the parameters Cmax ( prediction error < 2% , absolute percentage < 9%) . The combination of C1.5, C2, C6 might be chosen as sampling hours for predicting AUC0-t, and Cmax according to requirement. It is according with classical assessment. Conclusion The bioequivalence assessment results showed that LSS models provided correct assessment of bio equivalence between two amoxicillin preparations. The method is accurant and can be considered desirable for amoxicil lin bioequivalence study.%目的 用有限采样法(LSS)估算口服阿莫西林的生物等效性.方法 20名健康志愿者口服阿莫西林参比药物和受试药物500 mg后采集若干时间点血浆样品,用高效液相色谱法测定阿莫西林血药浓度,用经典方法计算药代动力学参

  8. Recommendations for on-site vibration standards

    International Nuclear Information System (INIS)

    Unless certain common sense precautions are observed, the luminosity of the Collider may be adversely affected by otherwise preventable ground vibrations. Previous work indicates that ground vibrations can be thought of as being caused by the sum of (a) natural and (b) cultural (i.e., man-made) effects, of which the latter can be further divided into uncontrollable and controllable. Examples of category (b) include: traffic, both on site and off site; construction activity on site and off site; assembly of equipment in nearby I.R. Halls, even footsteps in the tunnel; or continuously operating machinery. This note addresses question with respect to category (b) iv., only. As a guide, the order of magnitude of amplitudes and frequencies of presently, (on site) known noise polluters is described in relation to naturally occurring disturbances and to the tolerances required for successful Collider operation. Some methods of mitigating the effects of on site machinery are suggested. Finally, a vibration tolerance level specification is recommended as well as a mechanism to police adherence to such standards. 6 figures

  9. Feasibility study on dietary recommendations for older adults in the European Union

    OpenAIRE

    MAK TSZ NING; MUSSIO FLAMINIA; LOURO CALDEIRA SANDRA

    2015-01-01

    Despite mounting scientific evidence to support healthy and balanced diet in promoting active and healthy ageing, targeted, age-specific, and up-to-date dietary recommendations for older adults in Europe are not easy to find. On the 23-24 October 2014, the JRC organised an expert workshop "Feasibility study on dietary recommendations for older adults in the European Union" to discuss the need for dietary recommendations targeting older adults in Europe, and to identify strategies to promote b...

  10. Mouthrinse recommendation for prosthodontic patients

    Directory of Open Access Journals (Sweden)

    Sheila Cavalca CORTELLI

    2014-01-01

    Full Text Available Different reasons can contribute to classifying dental prosthesis wearers as high-risk individuals in relation to dental biofilm accumulation. These include a past history of oral disease, age and additional retentive areas. Other common complaints include inflammation and halitosis. Moreover, prosthesis replacement and prosthetic pillar loss are generally associated with caries and periodontal disease recurrence. Therefore, the present study undertook to make a critical review of the literature, aiming at discussing the main aspects related to chemical agent prescriptions for dental prosthesis wearers. Most of the articles were selected based on relevance, methods and availability in regard to the specific subject under investigation, without considering publication year limitations. Different types of prostheses and their impact on teeth and other oral tissues were reported. It was demonstrated that there is greater biofilm buildup and increased inflammatory levels in the presence of different types of prostheses, suggesting that additional measures are required both on population-wide and individual levels in order to control these factors. Mechanical control consists of a combination of manual or electric toothbrush and toothpaste, as well as specific devices for interdental cleaning. Although many chemical agents exhibit antimicrobial benefits when used for prosthesis disinfection, only a few agents can be used safely without causing damage. Regarding the selection of antiseptics by the overall population, chlorhexidine is the most indicated in the short term and in sporadic cases. The most indicated adjuncts to overcome the deficiencies and limitations of daily mechanical biofilm control are products containing essential oils as active ingredients.

  11. Summary of Technical Sessions - Summary and Recommendations

    International Nuclear Information System (INIS)

    margins or the use of PSA. This session comprised 7 papers. The recommendations of the workshop can be summarized by emphasizing that a great advance has been achieved since the beginning of BEPU activities, pointing to the consolidation of practices and nevertheless identifying still pending concerns. While the added value to safety with origin in the use of BEPU methods is recognized, the full potential of BEPU approach to a comprehensive safety assessment is still pending with regard to development. The CSNI and other international organizations like IAEA should play a leading role in this advancement

  12. Study of LC- MS- MS determination of bioequivalence and human pharmacokinetics of Clarithromycin tablets%克拉霉素片剂的人体药动学及生物等效性LC-MS-MS法研究

    Institute of Scientific and Technical Information of China (English)

    赵杰; 张海朋; 薛文华; 梁淑红

    2011-01-01

    Objective To establish a LC - MS - MS method for determinating the concentration of Clarithromycin, and to study pharmacokinetics and bioequivalence of Clarithromycin tablets in healthy volunteers.Methods Twenty- four healthy volunteers were randomly given an oral single dose of 500mg test and reference Clarithromycin tablets in a crossover manner.The concentrations of Clarithromycin were assayed by LC - MS - MS at different time points.The main pharmacokinetic parameters and the relative bioavailability of two preparations were calculated, and their bioequivalence was evaluated.Results The pharmacokinetic parameters of the reference and tested tablets were as follows:T1/2 being (5.271 ± 1.835 ) h and (5.032 ± 1.257 ) h, Tmax being ( 2.24 ± 1.41 ) h and ( 1.81 ±1.20)h,Cmax being (1831 ±539) ng/ml and (2085 ±582)ng/ml,AUC0-24 being (14172 ±3125)ng· h/ml and ( 15169 ± 3548 ) ng · h/ml, AUC0 - inf being ( 15339 ± 2989) ng · h/ml and ( 15730 ±3586) ng · h/ml,relative bioavailability of the test preparation was 93.43%.Conclusions The two Clarithromycin preparations tested in the present study are bioequivalent.%目的 建立LC-MS-MS法测定人血浆中克拉霉素的浓度,研究克拉霉素片剂的人体药动学和生物等效性.方法 24名健康受试者单剂量交叉口服受试制剂和参比制剂500mg,采用LC-MS-MS法测定血浆中不同时间点克拉霉素的药物浓度,计算主要药代动力学参数及相对生物利用度,评价两种制剂的生物等效性.结果 受试制剂和参比制剂的主要药动学参数分别为:T1/2(5.271±1.835)h和(5.032±1.257)h,Tmax为(2.24±1.41)h和(1.81±1.20)h,Cmax为(1831±539)ng/ml和(2085±582)ng/ml,AUCO-24为(14172±3125)ng·h/ml和(15169±3548)ng·h/ml,AUCO-inf为(15339±2989)ng·h/ml和(15730±3586)ng·h/ml,试验制剂克拉霉素相对生物利用度F为93.43%.结论 两种克拉霉素片剂具有生物等效性.

  13. 国产盐酸米多君片在健康人体的生物等效性研究%Bioequivalence of domestic midodrine hydrochloride tablets in healthy volunteers

    Institute of Scientific and Technical Information of China (English)

    孙军; 李珍; 计一平; 刘罡一; 余琛; 胡晋红

    2012-01-01

    目的:比较国产与进口盐酸米多君片在健康人体的生物等效性.方法:20名健康男性受试者随机交叉单剂量口服国产(受试制剂)或进口盐酸米多君片(参比制剂)5 mg,用液相色谱-串联质谱法测定血浆中盐酸米多君的活性代谢产物脱甘氨酸米多君的浓度,以DAS 2.0软件计算药动学参数,进行生物等效性评价.结果:受试制剂和参比制剂的药动学参数分别为:t1/ 2 (3.19±0.33)和(3.02±0.31)h,tmax(0.6±0.3)和(0.7±0.5)h,Cmax(21.72±6.06)和(21.83±6.24) μg/L,AUC0~t (65.27±8.43)和(65.64±7.08) μg·h·L-1,AUC0~∞(70.08±9.05)和(69.85±7.83) μg·h·L-1.按AUC0~∞计算,国产盐酸米多君片的相对生物利用度为( 100.3±6.8)%.结论:国产与进口盐酸米多君片在健康人体内具有生物等效性.%Objective:To evaluate the bioequivalence of domestic and imported midodrine hydrochloride tablets in healthy volunteers. Methods; A randomized cross-over trial was performed in 20 healthy male volunteers. Each volunteer was randomized to receive a single dose of 5 mg domestic and imported midodrine hydrochloride tablets. Plasma concentrations of desglymidodrine were measured with HPLC-MS/MS method. The pharmacokinetic parameters were calculated with DAS 2.0 software, then bioequivalence of the two preparations was evaluated. Results: The main pharmacokinetic parameters of the domestic and imported preparations were as follows:f1/2(3. 19 + 0. 33) vs (3.02 + 0.31) h,tmax(0. 6 + 0. 3) vs (0.7 + 0.5) h, cmax(21. 72±6. 06) vs (21.83±6.24) μg/L, AUC0-, (65.27±8. 43) vs (65. 64±7.08) μg o h o L-1 ,AUC. (70.08±9.05) vs (69.85±7.83) μg o h o L-1 , respectively. Relative bioavailability of the domestic midodrine hydrochloride tablets was (100.3± 6. 8) % , when calculated according to AUC0. Conclusion:The two preparations of midodrine hydrochloride are bioequivalent in healthy volunteers.

  14. 佐匹克隆片人体相对生物利用度与生物等效性研究%Relative Bioavailability and Bioequivalence of Zopiclone Tablets in Healthy Volunteers

    Institute of Scientific and Technical Information of China (English)

    陈倩; 刘宇; 任秀华; 张冬林; 刘东

    2012-01-01

    Objective To investigate the pharmaeoknietics and bioequivalence of zopiclone test and control tablets in health volunteers. Methods A single oral dose of 15 mg zopiclone test or control tablets were given to 20 healthy male volunteers in a randomized, two-way crossway study. HPLC- fluorescence detector was used to determine the concentralion of zopiclone in plasma. By the DAS 2. 1 pharmacokinetic software, the pharmacokinetic parameters of the two preparations were calculated and the bioequivalence of two tablets was evaluated. Results The main pharmacokinetic parameters of test and control preparations were as follows: t1/2 were (4.93±2.45) and (5.46±2.51) h; Cmax were (101. 18+23.47) and (105.39± 35.21) ng ·mL-1 ;tmax were( 1.60+1.16) and ( 1.64± 1. 35) h; AUC0.24 were (612. 66+ 157. 35) and (617.27 + 207. 11) ng · h · mL-1 ; AUC0-∞ was (664. 88+ 160. 27) and (679. 12+223. 75) ngoh o mL-1 ; The relative bioavailability of test preparations (Fo_1) was calculated to be (105. 1 ±28. 9)% according to AUC0.\\. Conclusion The two kinds of domestic preparations are bioequivalent.%目的 考察佐匹克隆片受试制剂和参比制剂的人体相对生物利用度,评价两种制剂生物等效性.方法 采用两制剂双周期交叉试验方法,20例男性健康受试者分别口服佐匹克隆片受试制剂或参比制剂15 mg,高效液相色谱荧光检测法检测血浆佐匹克隆浓度,DAS2.1药动学软件分析,并作生物等效性评价.结果 受试制剂与参比制剂t1/2分别为(4.93±2.45)和(5.46±2.51) h;Cmax分别为(101.18 ±23.47)和(105.39 ±35.21) ng·mL-1;tmax分别为(1.60±1.16)和(1.64 ±1.35)h;AUCo-24分别为(612.66±157.35)和(617.27±207.11) ng· h· mL-1;AUC0-∞分别为(664.88±160.27)和(679.12 ±223.75) ng·h· mL-1.根据AUC0-1计算,受试制剂的相对生物利用度F0-t为(105.1±28.9)%.结论 两种佐匹克隆片生物等效.

  15. Study on Bioequivalence of Cefdinir Capsules in Chinese Healthy Volunteers%头孢地尼胶囊在健康人体的生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    陈芬; 朱超然; 翟学佳; 冯霞; 邓桂萍; 郭卿; 蒋立芬; 吕永宁

    2015-01-01

    目的:评价健康人餐后服用两种头孢地尼胶囊的生物等效性。方法24例男性健康志愿者餐后随机交叉单剂量口服头孢地尼胶囊受试制剂或参比制剂,头孢地尼体内血药浓度采用液相色谱-质谱串联( LC-MS/MS)法测定,药动学参数及等效性采用药动学软件DAS计算和评价。结果受试制剂和参比制剂的主要药动学参数如下:AUCt分别为(4.35±1.09)和(4.12±1.22)μg��h��mL-1,AUC0-∞分别为(4.53±1.12)和(4.53±1.73)μg��h��mL-1,t1/2分别为(1.74±0.29)和(2.13±1.65) h,tmax分别为(4.44±0.86)和(4.54±1.16) h,Cmax分别为(900±250)和(876±269) ng��mL-1。结论头孢地尼胶囊受试制剂与参比制剂具有生物等效性。%Objective To evaluate postprandial pharmacokinetics and bioequivalence of two preparations of cefdinir capsules in Chinese healthy volunteers. Methods In a two-way cross-over study, 24 healthy male volunteers were divided into two groups randomly and a single dose of cefdinir capsules of test and reference preparation were administered orally, respectively.The concentration in plasma was determined by LC-MS/MS. Pharmacokinetic parameters and bioequivalence were calculated and evaluated by DAS. Results The main pharmacokinetic parameters of test and reference were as follows: AUCt (4.35±1.09) μg��h��mL-1 and (4.12±1.22) μg��h��mL-1, AUC0-∞(4.53±1.12) and (4.53±1.73) μg��h��mL-1, t1/2 (1.74±0.29) h and (2.13±1.65) h, tmax(4.44±0.86) h and (4.54 ±1.16) h, Cmax(900±250) ng��mL-1 and (876±269) ng��mL-1 . Conclusion The test and reference preparation of cefdinir capsules are bioequivalent.

  16. Bioequivalence of Clarithromycin soft capsules in healthy Chinese volunteers%克拉霉素软胶囊在中国健康人体的生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    马萍; 李鹏飞; 王淑民; 汪娟; 王燕; 谢晓娟; 刘丽宏

    2012-01-01

    AIM: To evaluate the bioequivalence of Clarithromycin soft capsule in healthy Chinese volunteers. METHODS: A single oral doses of 0. 25 g Clarithromycin soft capsule and tablet (test and reference) were given to 20 healthy volunteers according to an open randomized crossover design. The concentrations of Clarithromycin in plasma were determined by LC-MS/MS. With the aid of BAPP2. 0.the bioequivalence of the test and reference preparation were calculated by analysis of variance, tow one sided t-test. RESULTS: The pharmacokinetic parameters of the two preparations were as follow ;tmax of test drug and reference drug were (2. 1 ± 0. 6),(2.0 + 0. 8)h, Cmax were(815 + 191),(800 ±200) ng/mL, t1/2 were (4. 0 + 0. 4)、 (3. 9 ± 0.5) h, AUC0-24, were (5612 ± 1283), (5246 ± 1375) ng·h·mL-1, AUC0-∞ were (5722 ± 1313),(5339± 1402) ng · h · mL-1 , respectively. The relative bioavailability of the test formulation were (110.5 + 23.9)%. CONCLUSION: The tested preparation was of bioequivalence to the reference preparation.%目的:评价受试制剂克拉霉素软胶囊与参比制剂克拉霉素片在中国健康人体中的生物等效性.方法:采用双周期随机交叉试验设计,入选20名男性健康受试者单剂空腹口服参比制剂和受试制剂0.25g,采用液相色谱-串联质谱法(LC-MS/MS)测定血浆中克拉霉素的浓度,经BAPP2.0软件处理参数,并进行双单侧t检验确定是否生物等效.结果:主要药代动力学参数:受试制剂和参比制剂克拉霉素的达峰时间tmax分别为(2.1±0.6)、(2.0±0.8)h;Cmax分别为(815±191)、(800±200)ng/mL;t1/2分别为(4.0±0.4)、(3.9±0.5)h;AUC0-24h分别为(5612±1283)、(5246±1375)ng·h·mL-1;AUC0-∝分别 为 (5722 ± 1313)、 (5339 ±1402) ng·h·mL-1.受试制剂与参比制剂的相对生物利用度为(110.5±23.9)%.结论:受试制剂克拉霉素软胶囊与参比制剂克拉霉素片生物等效.

  17. 更昔洛韦分散片和胶囊在健康人体中的生物等效性%Bioequivalence of ganciclovir dispersible tablets and capsules in Chinese healthy volunteers

    Institute of Scientific and Technical Information of China (English)

    刘茜; 邓琳琳; 赵辉; 张旭; 刘洋

    2011-01-01

    目的 研究更昔洛韦分散片和胶囊在人体内的生物等效性.方法 采用双交叉随机自身对照试验设计,20名健康受试者分别单剂量口服更昔洛韦胶囊和分散片1 000 mg后,采用HPLC法测定血药浓度,DAS2.0软件计算药动学参数,并进行等效性检验.结果 更昔洛韦分散片和胶囊的主要药动学参数:pmax分别为(0.58±0.18)和(0.60±0.20)mg·L-1,Tmax分别为(3.0±0.4)和(3.2±0.4)h,t1/2分别为(4.6±1.3)和(4.6±0.8)h,AUC0-t分别为(2.8±0.8)和(3.2±1.2)mg·h·L-1,更昔洛韦分散片和胶囊的平均相对生物利用度为(96±28)%.结论 更昔洛韦分散片和胶囊在人体内生物等效.%AIM To evaluate the bioequivalence of ganciclovir dispersible tablets and capsules in Chinese healthy volunteers.METHODS In a randomized, crossover and self-controlled study, 20 male healthy volunteers were administered with a single oral dose of test and reference preparations containing 1 000 mg ganciclovir, respectively.The plasma concentrations of ganciclovir were determined by HPLC-UV.The pharmacokinetic parameters were calculated and the bioequivalence of the two preparations was evaluated by DAS software 2.0.RESULTS The main pharmacokinetic parameters of the ganciclovir dispersible tablets and capsules were as follows: pmax were (0.58 ± 0.18) and (0.60 ± 0.20) mg·L-1, τmax were (3.0 ± 0.4) and (3.2 ± 0.4) h, t1/2 were (4.6 ± 1.3) and (4.6 ± 0.8) h, AUC0-t were (2.8 ± 0.8) and (3.2 ± 1.2) mg·h·L-1.The relative bioavailability of ganciclovir dispersible tablets was (96 ± 28) %.CONCLUSION Ganciclovir dispersible tablets and capsules are bioequivalent.

  18. Bioequivalence of Amoxicillin Suspension Injection in Pigs%阿莫西林混悬注射液在猪体内的生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    潘娟; 严凤; 顾欣

    2015-01-01

    为了研究阿莫西林混悬注射液在猪体内的药代动力学和生物等效性,采用双处理、双周期随机交叉试验设计,将24头健康猪随机分成2组,按15 mg/kg体重肌肉分别单剂量注射受试制剂和参比制剂,采用高效液相色谱法测定血浆中阿莫西林的浓度,利用WinNonlin6.4软件计算主要药动学参数,并评价两种制剂的生物等效性。结果显示,受试制剂和参比制剂的 Tmax分别为(3.45±2.49) h,(1.34±1.74) h;Cmax分别为(6.94±4.73) mg/L,(4.39±2.87) mg/L;AUC0-t分别为(37.00±11.48) mg·h·L-1,(30.02±8.93) mg·h·L-1;AUC0-∞分别为(40.26±13.36) mg·h·L-1,(38.46±15.38) mg·h·L-1。阿莫西林混悬注射液受试制剂和参比制剂的AUC0-t、AUC0-∞、Cmax、Tmax均有显著性差异,双单侧t检验结果显示两种制剂生物不等效,试验为兽医临床给药方案的制定以及合理用药提供参考。%To evaluate the pharmacokinetics and bioequivalence of amoxicillin suspension injection in pigs. In a randomized two-way self-crossover study, 24 healthy pigs were randomly divided into two groups, and were given respectively a single dose of test or reference preparations by intramuscular injection ( 15 mg/kg ) . Plasma concentrations of amoxicillin were measured by HPLC. The pharmacokinetic parameters were calculated by WinNonlin6.4 software, and the bioequivalence were evaluated. The main pharmacokinetic parameters of the test and reference preparations were as follows: Tmax were ( 3. 45 ± 2. 49 ) h, ( 1. 34 ± 1. 74 ) h; Cmax were (6.94±4.73) mg/L, (4.39±2.87) mg/L; AUC0-t were (37.00±11.48) mg·h·L-1, (30.02±8.93) mg·h·L-1;AUC0-∞ were (40.26±13.36) mg·h·L-1, (38.46±15.38) mg·h·L-1. The pharmacokinetic parameters (AUC0-t、AUC0-∞, Cmax、Tmax) showed significant difference between test and reference preparations of

  19. Pharmacokinetics and Bioequivalence of Fluconazole Tablets in Healthy Volunteers%氟康唑片在健康人体的药物动力学和生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    巩慧敏; 冯泽岸; 邵婷玑; 张冬慧; 乔华; 廖明琪

    2012-01-01

    Objective: To study the relative bioavailability and bioequivalence of fluconazole tablets in healthy volunteers. Method : Twenty healthy male volunteers were involved in a double periodic self-cross randomized trial with a single dose of 200 mg of test and reference tablets. The fluconazole concentrations in plasma were determined by reversed-phase high-performance liquid chromatog-raphy-UV, and the pharmacokinetic parameters and bioequivalence of the tablets were analyzed through DAS 2.0 software. Result; The pharmacokinetic parameters of the test and reference tablets in plasma were as follows; tmas of(1. 08 ±0.44) and( 1. 35 ± 0. 76) h, C?*of(5.40±0.60)and(5.37±0.72)μg ·ml-1 ,ti/2 of (29.1 ±3.4) and (29.0 ±3.5)h,AUC(0_t) of(191. 3 ± 13. 8)and (190.4 ±15.7) μg ·h ·ml-1,A[/C(ll..) of (204.0±17.5) and(202.4 ± 18.1) μg -h -ml"1 ,MRT of(34.7 ± 1.7)and(34.0 ± 1.9)h, respectively. The relative bioavailability of the test preparation was 100.9% ±6.8%. Conclusion; The test tablets are bioequivalent to the reference tablets in the clinical research.%目的:研究氟康唑片在健康人体的药物动力学并评价其生物等效性.方法:采用双周期自身随机交叉试验设计.20名健康男性志愿者分别单剂量口服受试制剂和参比制剂200 mg,以非那西丁为内标,采用HPLC法测定血药浓度.用DAS软件计算药动学参数和进行统计分析.结果:单次口服受试制剂和参比制剂200 mg后的主要药动学参数:tmax(1.08±0.44)和(1.35±0.76)h,Cmax (5.40±0.60)和(5.37±0.72) μg ·ml-1,t1/2 (29.1±3.4)和(29.0±3.5)h,AUC(0-t)(191.3±13.8)和( 190.4±15.7) μg·h·ml-1,AUC(0-∞)(204.0±17.5)和(202.4±18.1)μg·h·ml-1,M RT( 34.7±1.7)和(34.0±1.9)h,以AUC(0-t)计算,受试制剂的相对生物利用度为100.9%±6.8%.结论:两种氟康唑片剂具有生物等效性.

  20. Pharmacokinetics and Bioequivalence of Domestic Olanzapine Tablets in Healthy Chinese Volunteers%国产奥氮平片的人体药动学和生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    俞凌燕; 楼洪刚; 阮邹荣; 江波; 陈金亮

    2012-01-01

    目的 评价国产奥氮平片在中国健康人体中的药动学及生物等效性.方法 采用双周期交叉试验设计,20名健康男性受试者单次口服国产和进口奥氮平片5 mg,采用LC-MS/MS测定奥氮平血药浓度,计算两制剂的主要药动学参数和生物利用度,并进行生物等效性评价.结果 国产和进口奥氮平片的主要药动学参数如下:tmax分别为(4.25±1.33)和(4.55±1.10)h,ρmax分别为(9.62±1.79)和(9.69±2.18)ng·mL-1,t1/2分别为(31.71±6.87)和(32.46±5.67)h,AUC0-t分别为(327.19±60.55)和(324.39±70.84)ng·h·mL-1,AUC0-∞分别为(354.44±74.58)和(350.70±80.94)ng·h·mL-1.受试制剂的相对生物利用度F0-t为(102.93±18.22)%,F0-∞为(103.30±20.75)%,经统计分析,各药动学参数均无显著性差异(P>0.05)结论 两种奥氮平制剂在体内过程相似,两制剂人体生物等效,临床上可以替换使用.%OBJECTIVE To study the pharmacokinetics and bioequivalence of domestic olanzapine tablets in healthy Chinese volunteers. METHODS A single oral dose of 5 mg olanzapine tablets was given to 20 healthy male volunteers in a randomized cross-over study. The concentrations of olanzapine in plasma were determined by LC-MS/MS method. The pharmacokinetie parameters and relative bioavailability were calculated by DAS. Then the bioequivalence of two formulations was evaluated. RESULTS The pharmacokinetie parameters of domestic and imported formulations were as follows ;tmax (4. 25 ±1.33) and (4.55 ± 1. 10) h, pmax(9.62 ± 1.79) and (9. 69 ±2. 18) ng·mL-1, t1/2 (31.71 ±6.87) and (32.46+5.67) h, AUC0-t, ( 327. 19 ± 60. 55 ) and (324. 39 ± 70. 84) ng·h·mL-1 , and AUC 0-∞ (354.44 ±74. 58) and (350. 70 ± 80. 94) ng·h·ml-1 , respectively. The relative bioavailability was ( 102. 93 ±18. 22 ) % for F0-t and ( 103. 30 ± 20. 75 ) % for F0-x. There was no significant difference between the two preparations (P >0. 05). CONCLUSION The two preparations are bioequivalent and can

  1. Bioequivalence of Two Different Ivermectin Injections in Rabbits%两种伊维菌素注射液在家兔体内的生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    李朋朋; 张聪; 张晓会; 周德刚; 李召斌; 张晓东; 刘栓

    2016-01-01

    To evaluate the pharmacokinetics and bioequivalence of two kinds of ivermectin injections in rabbits,in a randomized two -way self -crossover study,16 healthy rabbits were randomly divided into two groups,and were given respectively a single dose of two kinds of ivermectin injection by subcutaneous injection (5 mg/kg).Plasma concentrations of ivermectin were measured by HPLC.The pharmacokinetic parameters were calculated by 3P97 pharmacokinetic software,and the bioequivalence were evaluated.The main pharmacokinetic parameters of the test and reference preparations were as follows:Tmax were (26.45 ±8.62)h,(22.33 ±11.72)h;Cmax were (182.73 ± 59.27)ng/mL,(166.77 ±65.25)ng/mL;AUC0 -t were (21122 ±9999)ng·h·L -1 ,(19475 ±7009)ng·h·L -1;AUC0 -∞were (27390 ±12197)ng·h·L -1 ,(31559 ±13412)ng·h·L -1 .The pharmacokinetic parameters (AUC0 -t、AUC0 -∞、Cmax、Tmax ) showed no significant difference between test and reference preparations of ivermectin injections.The test and reference formulations were bioequivalent after two one -side t -test.This study provided theoretical basis for making of veterinary clinical dosage regimen and clinical rational administration.%为评价两种伊维菌素注射液在家兔体内的生物等效性,采用双周期交叉给药方式,将16只健康家兔随机分成2组,按5 mg/kg 体重皮下单剂量注射两种伊维菌素注射液,使用 HPLC法测定血浆中的伊维菌素,利用3P97药动软件计算主要药动学参数。结果显示,受试制剂和参比制剂的 Tmax分别为(26.45±8.62)h,(22.33±11.72)h;Cmax 分别为(182.73±59.27)ng/mL,(166.77±65.25)ng/mL;AUC0-t 分别为(21122±9999)ng·h·L -1,(19475±7009)ng·h·L -1;AUC0-∞分别为(27390±12197)ng·h·L -1,(31559±13412)ng·h·L -1。伊维菌素注射液受试制剂与参比制剂的 AUC0-t、AUC0-∞、Cmax、Tmax均无显著性差异(P >0.05

  2. Bioequivalence of levofloxacin lactate tablets in healthy volunteers%乳酸左氧氟沙星片在健康志愿者体内的生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    杜姗; 陈玺; 王凌; 王婷; 蒋学华

    2012-01-01

    Objective To investigate the bioequivalence of two different levofloxacin lactate tablets in healthy volunteers. Methods A single oral dose of 200mg of test and reference preparation was given respectively to 24 healthy male volunteers according to an open randomized crossover design. The plasma concentration of levofloxacin was determined by HPLC-UV method, the pharmacokinetic parameters were calculated and the bioequivalence of the two preparation was evaluated. Results The main pharmacokinetic parameters of 200mg of test and reference preparation were as followings: Tmax were (0.97±0.47)h and (l.ll±0.47)h; Cmax were (2587.09±703.87)ng/mL and (2215.54±427.96)ng/mL; t1/2were (7.93±1.16)h and (7.89±1.23)h; AUC0-r were (19481.36±2675.32)h/(ng/mL) and (18793.04±2595.71)h.ng/mL; AUC0-∞ were (20323.35±2798.09)h/(ng/mL) and (19602.06±2774.75)h/(ng/mL), respectively. The relative bioavailability of levofloxacin lactate tablets was (104.7±15.3)%. Conclusion The results showed that the two preparation were bioequivalent.%目的 研究两种乳酸左氧氟沙星片在健康志愿者体内的生物等效性.方法 采用随机双交叉自身对照试验设计,24名健康志愿者随机交叉单剂量口服200mg受试制剂和参比制剂.采用HPLC-UV法测定受试者血浆中左氧氟沙星的浓度,计算药动学参数,评价两制剂的生物等效性.结果 乳酸左氧氟沙星片受试制剂和参比制剂的主要药动学参数如下:Tmax分别为(0.97±0.47)、(1.1 1±0.47)h; Cmax分别为(2587.09±703.87)、(2215.54±427.96)ng/mL; t1/2分别为(7.93±1.16)、(7.89±1.23)h、AUC0-t分别为(19481.36±2675.32)、(18793.04±2595.71)h.ng/mL; AUC0-∞分别为(20323.35±2798.09)、(19602.06±2774.75)h/(ng/mL);以AUC0-t计算乳酸左氧氟沙星片受试制剂的相对生物利用度为(104.7±15.3)%.结论 两种制剂在健康志愿者体内生物等效.

  3. 盐酸美金刚片在中国健康人体的生物等效性%Study on the bioequivalence of memantine hydrochloride tablets in Chinese healthy volunteers

    Institute of Scientific and Technical Information of China (English)

    郑恒; 周华; 任丽; 钱振宇; 彭彦

    2012-01-01

    目的:评价国产与进口盐酸美金刚片在中国健康人体的生物等效性.方法:20名健康男性受试者随机交叉单剂量口服受试制剂或参比制剂盐酸美全刚片各10 mg.用高效液相色谱-串联质谱法测定血浆中美金刚浓度;用DAS3.0软件计算药动学参数,并对两种药物进行生物等效性评价.结果:受试制剂和参比制剂的主要药动学参数:Cmax分别为(18.1±3.8)和(20.3±4.2)ng·mL-1;tmax分别为(12.7±15.1)和(8.8±3.0)h;t1/2分别为(60.8±15.5)和(61.4±19.2)h;AUC0-t分别为(1748.6±338.9)和(1720.2±317.3)ng·h·mL-1.AUC0-t、AUC0-∞、Cmax的90%置信区间分别为89.8%~105.6%、89.7%~106.1%、84.8%~93.9%.受试制剂相对生物利用度F0-t为(95.5±2.9)%.结论:受试制剂与参比制剂具有生物等效性.%OBJECTIVE To evaluate the bioequivalence of two preparations of memantine hydrochloride in healthy volunteers. METHODS A single oral dose of 10 mg test preparation or reference preparation memantine hydrochloride tablets were given to 20 male healthy volunteers in a randomized crossover study. The concentrations of memantine were determined by HPLC-MS/MS method. The pharmacokinetic parameters and relative bioavailability were calculated by DAS 3. 0 software, and then the bioequivalence was judged. RESULTS The main pharmacokinetic parameters of test preparation and reference preparation were as follows: Cmax was (18. 1 ±3.8), (20. 3 ±4. 2) ng·mL-1; t max was (12. 7 ± 15. 1), (8.8 ± 3.0) h; t1:2 was (60.8 + 15.5), (61. 4 ± 19.2) h; AUC0-t was (1 748. 6 ± 338. 9). (1 720. 2 ± 317. 3) ng·h· mL-1 , respectively. The 90% CIs for the ratios of AUG0-T、AUG0-∞ ,C max were 89. 8% ~1()5. 6%,89. 7%~106. 1%,84. 8%~93. 9%, respectively. The relative bioavailability of test preparation was (95.5 ±2. 9)%. CONCLUSION The results demonstrated that the two preparations were bioequivalent.

  4. Bioequivalence of Felodipine Sustained-release Tablets in Healthy Volunteers%非洛地平缓释片在健康志愿者体内的生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    刘异; 裘琳; 饶子超; 刘东

    2013-01-01

    目的 建立测定血浆非洛地平浓度的高效液相色谱-质谱串联法,研究非洛地平缓释片的相对生物利用度及生物等效性.方法 采用双周期交叉试验方法,20例男性健康志愿者分别单剂量口服非洛地平缓释片试验药或对照药.采用高效液相色谱-质谱串联法测定血浆非洛地平浓度,用DAS2.0软件对两药进行等效性评价.结果 试验药与对照药的主要药动学参数:血药峰浓度(Cmax)分别为(2.15±0.63)和(2.29±0.63) ng·mL-;达峰时间(tmax)分别为(6.33±1.57)和(6.68±1.32)h,半衰期(t1/2)分别为(18.22±2.75)和(19.04±2.27)h,药物浓度-时间曲线下面积(AUC0-48)分别为(58.11±5.15)和(61.13-±6.31) ng·mL-1·h.受试制剂对参比制剂平均相对生物利用度F为(95.06±8.42)%.结论 两种非洛地平缓释片生物等效.%Objective To set up a method for determination of felodipine in human plasma by HPLC-MS/MS and study the relative bioavailability and bioequivalence of felodipine sustained - release tablets. Methods Twenty healthy male volunteers were randomized to receive a single dose of tested felodipine sustained-release tablet or the reference tablet by a two-way crossover design. Plasma concentration of felodipine was determined by HPLC-MS/MS and the bioequivalence between two formulations were evaluated by DAS2. 0 program. Results The pharmacokinetic parameters of the tested and the reference felodipine tablet were expressed as follows: Cmax was (2. 15±0. 63) ng · mL-1 and (2. 29±0. 63) ng · mL-1 , tmax was (6. 33± 1.57) h and (6.68±1.32) h, t1/2 was (18.22±2.75) h and (19.04±2.27) h, AUC0-48 were (58. 11±5. 15) ng · mL-1 · h and (61. 13±6. 31) ng · mL-1· h. The relative bioavailability F was (95.06±8.42) %. Conclusion The two felodipine sustained-release tablets are bioequivalent.

  5. Determination of lisinopril in human plasma by HP LC-MS/MS and bioequivalence of lisinopril tablets%赖诺普利片人体生物等效性研究

    Institute of Scientific and Technical Information of China (English)

    周焕; 陈余清; 马涛; 霍强; 孙思雨; 张俊东

    2012-01-01

    Objective :To evaluate the bioequivalence of lisinopril tablets in healthy volunteers. Methods: A single oral dose of 10 mg test or reference formulations were given to 20 male healthy volunteers in a randomized crossover design. Three ml of blood was drawn out from the ulnar vein of the volunteers at 1,2,3 ,4 ,6,8 ,10,12,16,24,36,48 and 60 h before and after the administration. The plasma concentration of lisinopril was determined by LC-MS/MS method. The pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two formulations. Results: The pharmacokinetic parameters of lisinopril test formulation were obtained as follows-tmax was(6. 1 ±1.0) h,Cmax(64. 24 ±25.2) μg/L, AUC0_60 (942. 0 ±330) (μg ? T-1 ? h-1 and AUC0-∞ (969.6 ±327) μg ? L-1 ? h-1 ;for reference formulation:tmas(6. 1 ± 1. 2) h,Cmax (68. 19 ±26. 5 ) μg/L, AUC0-144(980.1 ±340) μg ? L-1 ? h-1 and AUC0-∞ (1002.3 ±337) μg ? L-1 ? h-1. Calculated with AUC0-144 ,the bioavailability of the two formulations was(98. 8 ±27. 5) %. Conclusions:The lisinopril tablet test formulation and reference formulation are bioequivalent.%目的:评价两种赖诺普利片的人体生物等效性.方法:20名男性健康志愿者随机交叉口服赖诺普利片试验制剂和参比制剂各10 mg,于给药前及给药后1、2、3、4、6、8、10、12、16、24、36、48、60 h从受试者肘静脉采血3 ml,采用液相-串联质谱法(LC-MS/MS)测定血药浓度.以DAS2.0软件计算其药动学参数,考察其生物等效性.结果:赖诺普利片试验制剂和参比制剂的tmax、Cmax、AUC0~60、AUC0~∞分别为(6.1±1.0)h和(6.1±1.2)h、(64.24±25.2)μg/L和(68.19±26.5)μg/L、(942.0±330)μg·L-1·h-1和(980.1±340)μg·L-1·h-1、(969.6±327)μg·L-1·h-1和(1002.3±337)μg·L-1·h-1.以AUC0~144计算,赖诺普利片试验制剂和参比制剂比较的人体相对生物利用度为(98.8±27.5)%.结论:试验制剂赖诺

  6. 非洛地平缓释片在中国健康男性的生物等效性%Bioequivalence of felodipine extended release tablets in Chinese healthy male subjects

    Institute of Scientific and Technical Information of China (English)

    许俊羽; 赵侠; 孙严彤; 顾景凯; 王梓凝; 张冬梅; 周颖; 梁雁; 崔一民

    2013-01-01

    目的 评价2种非洛地平缓释片在健康中国男性人体的生物等效性.方法 用双交叉设计,24名健康男性受试者随机分为2组,单剂量口服非洛地平缓释片试验药物或对照药物5mg,用液相色谱-串联质谱法测定血浆非洛地平血药浓度,用DAS 2.0软件计算药代动力学参数.结果 试验药物与对照药物的Cmax分别为(2.15±1.37),(1.67±0.87) ng·mL-1;Tmax分别为(5.40±3.42),(5.85±4.84)h;t1/2分别为(16.51±5.82),(18.78±8.16)h;AUCo-72h分别为(37.68±22.05),(34.71±20.88)ng·h·mL-1;AUCo-∞分别为(39.90±23.64),(37.93±23.75)ng·h·mL-1;Cmax、AUCo-r2h和AUCo-∞的90%可信区间分别为109.6% ~ 141.6%,99.2% ~120.2%和96.2% ~117.8%.两制剂的Tmax非参数法检验差异无统计学意义.试验药物对于对照药物的平均相对生物利用度F为(114.0±33.7)%.结论 2种非洛地平缓释片剂在中国健康男性受试者体内具有生物等效性.%Objective To evaluate the bioequivalence of the two felo-dipine extended release tablets in Chinese healthy male subjects. Methods A single oral dose 5 mg of test and reference felodipine extended release tablets were given to 24 subjects according to an open randomized crossover design. The concentrations of felodipine in plasma were determined by LC - MS/MS. The pharmacokinetic parameters were calculated and the bioequivalence was compared by DAS 2. 0. Results The main pharmacokinetic parameters of felodipine of the test and reference preparations were as follows:Cmax were (2. 15 ± 1. 37) and (1. 67 ±0. 87) ng · mL-1; Tmax were (5. 40 ±3.42), (5. 85 ±4. 84) h; t1/2 were (16. 51 ±5.82) and (18.78 ±8. 16) h; AUC0-72hwere (37.68 ±22.05) and (34.71 ±20.88) ng · H · mL-1; AUC0_. Were (39. 90 ± 23. 64) and (37. 93 ±23. 75) ng · H · mL-1. The 90% confidential interval of Cmax, AUC0-72h and AUC0_∞ of tested formulation were 109. 6% ~ 141. 6% , 99. 2% ~ 120. 2 % and 96. 2% ~ 117. 8% . There was no

  7. 复方对乙酰氨基酚Ⅱ胶囊溶出度和人体生物等效性研究%Study on the Dissolution of Compound Paracetamol Ⅱ Capsules and Bioequivalence in Healthy Volunteers

    Institute of Scientific and Technical Information of China (English)

    余春梅; 周成林; 徐洁; 陈兰; 罗宏; 蒲道俊

    2013-01-01

    OBJECTIVE: To study the dissolution of Compound paracetamol Ⅱ capsules and bioequivalence of it and tablet on the market. METHODS: First method of appendix in 2010 edition of Chinese Pharmacopoeia (part Ⅱ XC) was adopted in the determination of dissolution, which was as follows: hydrochloric acid slontion as medium; rotation speed of 100 r/min; detection wavelength of 273 nm. By randomized crossover study of bioequivalence, 18 healthy volunteers were given Compound paracetamol Ⅱ capsules (test preparation) and Compound paracetamol Ⅱ tabelts (reference peparation). The blood concentration of paracetamol was determined by HPLC-MS/MS. RESULTS: The accumulative dissolution of paracetamol and caffeine in two preparations exceeded 85% in 15 mins; similarity factor (f2) of propyphenazone was 85; the relative bioavailability of test preparation to reference preparation were (103.2 ± 11.3)% for paracetamol, (108.0 ± 29.5)% for propyphenazone and (110.1 ± 48.3)% for caffeine. CONCLUSIONS: In vitro dissolution behavior of two preparations is similar, and two preparations are bioequivalent in vivo.%目的:研究复方对乙酰氨基酚Ⅱ胶囊的溶出度,并考察其与上市片剂的人体生物等效性.方法:溶出度测定方法采用2010年版《中国药典》(二部)附录XC第一法,以盐酸溶液为溶出介质,转速100 r/min,检测波长273nm;生物等效性采用随机双交叉试验,18名健康受试者分别单剂量口服复方对乙酰氨基酚Ⅱ胶囊(受试制剂)与片剂(参比制剂)后,用高效液相色谱串联质谱电喷雾(HPLC-MS/MS)法测定血药浓度,计算药动学参数,评价生物等效性.结果:受试制剂与参比制剂中对乙酰氨基酚和咖啡因在15 min时的累积溶出量>85%,异丙安替比林相似因子(f2)=85;受试制剂相对于参比制剂的生物利用度分别为对乙酰氨基酚(103.2±11.3)%、异丙安替比林(108.0±29.5)%、咖啡因(110.1±48.3)%.结论:两种制剂的体外溶出行为相似,体内生物等效.

  8. 2种西酞普兰制剂的人体生物等效性研究%Study on Bioequivalence of 2 Kinds of Citalopram Preparations in Healthy Volunteers

    Institute of Scientific and Technical Information of China (English)

    黄天文; 文隽; 潘文; 李艳; 雷宇

    2012-01-01

    目的:比较西酞普兰胶囊与片剂在健康人体内的生物等效性.方法:20名健康志愿者采用双周期交叉试验,单剂量空腹口服西酞普兰胶囊(受试制剂)与西酞普兰片(参比制剂)各40 mg,以高效液相色谱法测定其西酞普兰血药浓度,药-时数据经3p97软件处理,计算主要药动学参数,并进行2种制剂的生物等效性评价.结果:西酞普兰胶囊与片剂的主要药动学参数分别为tmax(36.9±9.1)、(39.3±6.8)h,cmax(68.7±5.6)、(71.8±6.9)μg·L-1,t1/2(4.3±1.1)、(4.6±1.0)h,AUC0~144h(2 418±636)、(2 483±342)μg·h·L-1,AUC0~∞(2 576±561)、(2 742±371)μg·h·L-1.西酞普兰胶囊的相对生物利用度为(98.8±11.4)%.结论:西酞普兰胶囊与片剂具有生物等效性.%OBJECTIVE: To compare the bioequivalence of Citalopram capsules and Citalopram tablets in healthy volunteers. METHODS: In bi-periodic cross-over study, 20 healthy volunteers were given Citalopram capsule 40 mg (test preparation) and Citalopram tablet 40 mg (reference preparation) orally respectively. The blood concentration of citalopram was determined by HPLC and pharmacokinetic parameters were calculated with 3p97 software. The bioequivalence of 2 kinds of preparations was evaluated. RESULTS: Main pharmacokinetic parameters of Citalopram capsules vs. Citalopram tablets were as follows: tmax(36.9±9.1)h and (39.3 ±6.8)h;Cmax(68.7 ±5.6)ng·L-1 and (71.8 ±6.9)ug-L-1;rM(4.3± l.l)h and (4.6 ±1.0) h; AUC0~144 h(2 418 ±636)μg·h· L-1 and (2 483 ± 342)μg·h·L-1; AUC0~00 were(2 576 ± 561)μg·h·L-1 and (2 742 ± 371) μg·h·L-1. The relative bioavailability of Citalopram capsules was (98.8 ±11.4)%. CONCLUSION: Citalopram capsule and Citalopram tablet are bioequivalent.

  9. Mobile Recommendation Based on Link Community Detection

    Directory of Open Access Journals (Sweden)

    Kun Deng

    2014-01-01

    Full Text Available Since traditional mobile recommendation systems have difficulty in acquiring complete and accurate user information in mobile networks, the accuracy of recommendation is not high. In order to solve this problem, this paper proposes a novel mobile recommendation algorithm based on link community detection (MRLD. MRLD executes link label diffusion algorithm and maximal extended modularity (EQ of greedy search to obtain the link community structure, and overlapping nodes belonging analysis (ONBA is adopted to adjust the overlapping nodes in order to get the more accurate community structure. MRLD is tested on both synthetic and real-world networks, and the experimental results show that our approach is valid and feasible.

  10. Assessment of individual dose utilization vs. physician prescribing recommendations for recombinant activated factor VII (rFVIIa) in paediatric and adult patients with congenital haemophilia and alloantibody inhibitors (CHwI): the Dosing Observational Study in Hemophilia (DOSE).

    Science.gov (United States)

    Gruppo, R A; Kessler, C M; Neufeld, E J; Cooper, D L

    2013-07-01

    Recent data from the Dosing Observational Study in Hemophilia diary study has described home treatment with recombinant activated factor VII (rFVIIa) in congenital haemophilia with inhibitors (CHwI). The current analysis compares prescribed and patient/caregiver-reported rFVIIa administration in paediatric and adult CHwI patients in this study. Patients with ≥ 4 bleeding episodes within a 3-month period prescribed rFVIIa as first-line therapy for bleeding episodes were eligible. Patients/caregivers completed a diary for ≥ 90 days or until the patient experienced four bleeds. Initial, total and mean rFVIIa doses reported for each bleeding episode were calculated and compared with the physician-prescribed doses. Of 52 enrolled patients (25 children; 27 adults), 39 (75%) completed the study. Children and adults had similar mean durations of bleeding episodes. Both patient groups were administered higher initial rFVIIa doses for joint bleeds than prescribed: median (range) 215.2 (74.1-400.0) mcg kg(-1) vs. 200.0 (61.0-270.0) mcg kg(-1) for children, and 231.3 (59.3-379.7) mcg kg(-1) vs. 123.0 (81.0-289.0) mcg kg(-1) for adults. The median infused dose for joint bleeds was higher in adults than children (175.2 vs. 148.0 mcg kg(-1) ), but children received significantly more doses per joint bleed than adults (median 6.5 vs. 3.0). The median total dose per joint bleed was higher in children than adults (1248.7 vs. 441.6). For children and adults, both initial and additional doses administered for bleeds were higher than prescribed. Children received higher total doses per bleed due to an increased number of infusions per bleed.

  11. Bioequivalent Evaluation of Two Brands of Losartan/Hydrochlorothiazide Compound Tablets in Healthy Chinese Male Volunteers%两种氯沙坦/氢氯噻嗪复方片剂的人体生物等效性评价

    Institute of Scientific and Technical Information of China (English)

    杨平; 李琳; 孙进; 何仲贵

    2006-01-01

    目的 评价两种氯沙坦/氢氯噻嗪(50 mg/12.5 mg)复方片剂在中国男性健康志愿者体内的生物等效性.方法 本研究采用随机、开放、双周期交叉设计,洗净期为7天.20名男性健康志愿者先后单剂量口服氯沙坦/氢氯噻嗪(50 mg/12.5 mg)受试及参比制剂.血药浓度由已确证的HPLC-ESI-MS法测定.结果 双单侧检验结果显示,氯沙坦的AUC0-12及Cmax的90%置信区间分别为86% - 112%及89% - 134%,氢氯噻嗪分别为85% - 100%及75% - 102%,均在中国药典所规定的可接受范围内.结论 两种速释氯沙坦/氢氯噻嗪复方片剂生物等效.%Aim To evaluate the bioequivalence of two brands of losartan/hydrochlorothiazide (50 mg/12.5 mg) compound tablets in healthy Chinese male volunteers. Methods An open, randomized, single-dose, two-period cross-over study with a wash-out period of 7 d was conducted. Twenty healthy male volunteers were given a single dose 50 mg losartan/12.5 mg hydrochlorothiazide of either test (T) or reference (R) compound tablets, respectively. Blood samples were collected up to 48 h after oral administration. The concentrations of losartan and hydrochlorothiazide in plasma were determined by a validated HPLC-ESI-MS method. Results In the case of losartan, the 90% confidence intervals of two one-side test for percent ratios with a significant level (α) of 0.05 were 86% - 112% for AUC0-12 and 89% - 134% for Cmax, respectively, which were within the interval proposed in the Chinese Pharmacopoeia, 80% - 125% of AUC and 70% - 143% of Cmax, respectively. Similarly, the 90% confidence intervals for percent ratios were 85% - 100% and 75% - 102% for hydrochlorothiazide, both of which fell into the accepted interval. Conclusion Two immediate-release compound tablets of losartan/hydrochlorothiazide are bioequivalent from a statistical standpoint in the extent and rate of absorption from the single-dose study in healthy Chinese male volunteers.

  12. Machine learning paradigms applications in recommender systems

    CERN Document Server

    Lampropoulos, Aristomenis S

    2015-01-01

    This timely book presents Applications in Recommender Systems which are making recommendations using machine learning algorithms trained via examples of content the user likes or dislikes. Recommender systems built on the assumption of availability of both positive and negative examples do not perform well when negative examples are rare. It is exactly this problem that the authors address in the monograph at hand. Specifically, the books approach is based on one-class classification methodologies that have been appearing in recent machine learning research. The blending of recommender systems and one-class classification provides a new very fertile field for research, innovation and development with potential applications in “big data” as well as “sparse data” problems. The book will be useful to researchers, practitioners and graduate students dealing with problems of extensive and complex data. It is intended for both the expert/researcher in the fields of Pattern Recognition, Machine Learning and ...

  13. Utility-based Recommendations for Networked Innovation

    NARCIS (Netherlands)

    Sie, Rory; Bitter-Rijpkema, Marlies; Sloep, Peter

    2010-01-01

    Sie, R. L. L., Bitter-Rijpkema, M. E., & Sloep, P. B. (2010, 2 November). Utility-based Recommendations for Networked Innovation. Poster presentation at the SIKS / SIREN day 2010, Veldhoven, The Netherlands.

  14. Percentage of Surgical Patients Receiving Recommended Care

    Science.gov (United States)

    ... view charts and maps. State Percentage of Surgical Patients Receiving Recommended Care by ... U.S. Department of Health & Human Services — 200 Independence Avenue, S.W. — Washington, D.C. 20201

  15. EURRECA—Framework for Aligning Micronutrient Recommendations

    NARCIS (Netherlands)

    Veer, van 't P.; Grammatikaki, E.; Matthys, C.; Raats, M.M.; Contor, L.

    2013-01-01

    There is currently no standard approach for deriving micronutrient recommendations, and large variations exist across Europe, causing confusion among consumers, food producers, and policy makers. More aligned information could influence dietary behaviors and potentially lead to a healthier populatio

  16. Personalized recommendation based on unbiased consistence

    Science.gov (United States)

    Zhu, Xuzhen; Tian, Hui; Zhang, Ping; Hu, Zheng; Zhou, Tao

    2015-08-01

    Recently, in physical dynamics, mass-diffusion-based recommendation algorithms on bipartite network provide an efficient solution by automatically pushing possible relevant items to users according to their past preferences. However, traditional mass-diffusion-based algorithms just focus on unidirectional mass diffusion from objects having been collected to those which should be recommended, resulting in a biased causal similarity estimation and not-so-good performance. In this letter, we argue that in many cases, a user's interests are stable, and thus bidirectional mass diffusion abilities, no matter originated from objects having been collected or from those which should be recommended, should be consistently powerful, showing unbiased consistence. We further propose a consistence-based mass diffusion algorithm via bidirectional diffusion against biased causality, outperforming the state-of-the-art recommendation algorithms in disparate real data sets, including Netflix, MovieLens, Amazon and Rate Your Music.

  17. Consistence beats causality in recommender systems

    CERN Document Server

    Zhu, Xuzhen; Hu, Zheng; Zhang, Ping; Zhou, Tao

    2015-01-01

    The explosive growth of information challenges people's capability in finding out items fitting to their own interests. Recommender systems provide an efficient solution by automatically push possibly relevant items to users according to their past preferences. Recommendation algorithms usually embody the causality from what having been collected to what should be recommended. In this article, we argue that in many cases, a user's interests are stable, and thus the previous and future preferences are highly consistent. The temporal order of collections then does not necessarily imply a causality relationship. We further propose a consistence-based algorithm that outperforms the state-of-the-art recommendation algorithms in disparate real data sets, including \\textit{Netflix}, \\textit{MovieLens}, \\textit{Amazon} and \\textit{Rate Your Music}.

  18. Recommended radiological controls for tritium operations

    International Nuclear Information System (INIS)

    This informal report presents recommendations for an adequate radiological protection program for tritium operations. Topics include hazards analysis, facility design, personnel protection equipment, training, operational procedures, radiation monitoring, to include surface and airborne tritium contamination, and program management

  19. Recommendations for mental health professionals in the NICU

    OpenAIRE

    Hynan, M T; Steinberg, Z; Baker, L; Cicco, R; Geller, P. A.; Lassen, S; Milford, C.; Mounts, K O; Patterson, C; Saxton, S; Segre, L; Stuebe, A

    2015-01-01

    This article describes recommended activities of social workers, psychologists and psychiatric staff within the neonatal intensive care unit (NICU). NICU mental health professionals (NMHPs) should interact with all NICU parents in providing emotional support, screening, education, psychotherapy and teleservices for families. NMHPs should also offer educational and emotional support for the NICU health-care staff. NMHPs should function at all levels of layered care delivered to NICU parents. M...

  20. Recommendations for a sustainable development of biofuels in France

    International Nuclear Information System (INIS)

    The biofuels are presented as a solution to the greenhouse gases and the petroleum consumption decrease. The development of the biofuels needs an active research of the production, transformation and use costs improvement. It will be necessary to prepare the market of the biofuels to the globalization. Some recommendations are also provided in the domains of the vegetal oil ester, the ethanol for the diesel and for the development of simulation tools to evaluate the costs. (A.L.B.)

  1. Towards a healthy diet: from nutrition recommendations to dietary advice

    OpenAIRE

    Andersson, Agneta; Bryngelsson, Susanne

    2007-01-01

    The scientific knowledge regarding dietary fat, carbohydrate and protein, and food for the youngest and oldest people, was presented by key scientists in the field at a symposium arranged in Uppsala on 14 December 2006. The quality of fat and carbohydrates, rather than the total amount, was emphasized. It was more difficult, however, to reach conclusions about the preferred type of dietary protein. Recent dietary recommendations, main activities and key messages to the public in the Nordic co...

  2. A Personalized Word of Mouth Recommender Model

    OpenAIRE

    Chihli Hung

    2008-01-01

    Word of mouth (WOM) has a powerful effect on consumer behavior. Manually collecting WOM is very time-consuming in the era of the Internet. An automatic WOM recommender model is useful for both marketers and consumers. There are many different product features and thus many consumer choices. Each individual consumer has different preferences and these preferences may be changed deliberately or unwittingly. However, most existing WOM recommender models do not adapt to user preferences. This stu...

  3. Revealing Hidden Connections in Recommendation Networks

    OpenAIRE

    Minhano, Rogerio; Fernandes, Stenio; Kamienski, Carlos

    2016-01-01

    Companies have been increasingly seeking new mechanisms for making their electronic marketing campaigns to become viral, thus obtaining a cascading recommendation effect similar to word-of-mouth. We analysed a dataset of a magazine publisher that uses email as the main marketing strategy and found out that networks emerging from those campaigns form a very sparse graph. We show that online social networks can be effectively used as a means to expand recommendation networks. Starting from a se...

  4. PDF4LHC recommendations for Run II

    CERN Document Server

    Rojo, Juan

    2016-01-01

    The interpretation of LHC measurements requires a careful estimate of various sources of uncertainties that affect theoretical calculations. In this contribution, we present the PDF4LHC Working Group recommendations for the usage of sets of parton distribution functions (PDFs) at the LHC Run II. We review the construction and validation of the PDF4LHC15 combined sets, and study some of their phenomenological implications. We also address some recent criticism of these recommendations.

  5. An Improved Recommendation Algorithm in Knowledge Network

    OpenAIRE

    Huiqing Niu; Hong Chen

    2013-01-01

    Knowledge sharing is an essential characteristic of knowledge network and knowledge recommendation is a good way to improve the quality of shared knowledge. To investigate more efficient knowledge recommendation algorithm, knowledge potential energy rank and interest measure of knowledge were added in the association rules. Augmentation and quantization of the two parameters is the most important innovation of the paper. There were three modules in the algorithm-mining knowledge association r...

  6. WWW COLLABORATIVE RECOMMENDATION BASED ON RELIABILITY

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    Collaborative filtering recommender systems often suffer from the "Matchmaker" problem, which comes from the false assumption that users are counted only based on their similarity, and high similarity means good advisers. In order to find good advisers for every user, a matchmaker's reliability mode based on the algorithm deriving from Hits is constructed, and it is applied in the proposed World Wide Web (WWW)collaborative recommendation system. Comparative experimental results also show that our approach obviously improves the substantial performance.

  7. A classification-based review recommender

    OpenAIRE

    O'Mahony, Michael P.; Smyth, Barry

    2010-01-01

    Many online stores encourage their users to submit product or service reviews in order to guide future purchasing decisions. These reviews are often listed alongside product recommendations but, to date, limited attention has been paid as to how best to present these reviews to the end-user. In this paper, we describe a supervised classification approach that is designed to identify and recommend the most helpful product reviews. Using the TripAdvisor service as a case study, we compare...

  8. A classification-based review recommender

    OpenAIRE

    O'Mahony, Michael P.; Smyth, Barry

    2009-01-01

    Many online stores encourage their users to submit product/service reviews in order to guide future purchasing decisions. These reviews are often listed alongside product recommendations but, to date, limited attention has been paid as to how best to present these reviews to the end-user. In this paper, we describe a supervised classification approach that is designed to identify and recommend the most helpful product reviews. Using the TripAdvisor service as a case study, we compare the perf...

  9. Concept-based Recommendations for Internet Advertisement

    CERN Document Server

    Ignatov, Dmitry I

    2009-01-01

    The problem of detecting terms that can be interesting to the advertiser is considered. If a company has already bought some advertising terms which describe certain services, it is reasonable to find out the terms bought by competing companies. A part of them can be recommended as future advertising terms to the company. The goal of this work is to propose better interpretable recommendations based on FCA and association rules.

  10. Recommendations of the French academy of medicine

    International Nuclear Information System (INIS)

    Recently the French academy of medicine (FAM) decided to make a point concerning radiological protection and issued the 6 following recommendations and statements: 1) FAM recommends the global reduction of the radiation dose received by patients during medical examination; 2) FAM recommends to promote and develop the research work concerning the biological effects of doses lower than 100 mSv; 3) FAM recommends to reject the linear-non threshold model for low dose radiation; 4) FAM agrees with the UNSCEAR report about the consequences of the Chernobyl accident, apart from the early fatalities in rescue workers, the main health effect is an increase risk of thyroid cancer in children, in particular, there has been no evidence of increase in other cancer incidence or in congenital malformation; 5) FAM recommends the introduction of the dari as a practical dose sub-unit, 1 dari represents the dose received by the whole body for 1 year due to natural radioactivity; and 6) FAM recommends that the European directive concerning the annual limit dose, maintains its value to 100 mSv a year. (A.C.)

  11. Recommendations for reducing ambiguity in written procedures.

    Energy Technology Data Exchange (ETDEWEB)

    Matzen, Laura E.

    2009-11-01

    Previous studies in the nuclear weapons complex have shown that ambiguous work instructions (WIs) and operating procedures (OPs) can lead to human error, which is a major cause for concern. This report outlines some of the sources of ambiguity in written English and describes three recommendations for reducing ambiguity in WIs and OPs. The recommendations are based on commonly used research techniques in the fields of linguistics and cognitive psychology. The first recommendation is to gather empirical data that can be used to improve the recommended word lists that are provided to technical writers. The second recommendation is to have a review in which new WIs and OPs and checked for ambiguities and clarity. The third recommendation is to use self-paced reading time studies to identify any remaining ambiguities before the new WIs and OPs are put into use. If these three steps are followed for new WIs and OPs, the likelihood of human errors related to ambiguity could be greatly reduced.

  12. Recent developments in affective recommender systems

    Science.gov (United States)

    Katarya, Rahul; Verma, Om Prakash

    2016-11-01

    Recommender systems (RSs) are playing a significant role since 1990s as they provide relevant, personalized information to the users over the internet. Lots of work have been done in information filtering, utilization, and application related to RS. However, an important area recently draws our attention which is affective recommender system. Affective recommender system (ARS) is latest trending area of research, as publication in this domain are few and recently published. ARS is associated with human behaviour, human factors, mood, senses, emotions, facial expressions, body gesture and physiological with human-computer interaction (HCI). Due to this assortment and various interests, more explanation is required, as it is in premature phase and growing as compared to other fields. So we have done literature review (LR) in the affective recommender systems by doing classification, incorporate reputed articles published from the year 2003 to February 2016. We include articles which highlight, analyse, and perform a study on affective recommender systems. This article categorizes, synthesizes, and discusses the research and development in ARS. We have classified and managed ARS papers according to different perspectives: research gaps, nature, algorithm or method adopted, datasets, the platform on executed, types of information and evaluation techniques applied. The researchers and professionals will positively support this survey article for understanding the current position, research in affective recommender systems and will guide future trends, opportunity and research focus in ARS.

  13. Content recommendation, a challenge for television

    Directory of Open Access Journals (Sweden)

    Joëlle Farchy

    2016-07-01

    Full Text Available In this article, we use the term recommendation in order to analyze every apparatus aimed at guiding the Internet user toward a specific content, surrounded by an overabundant and profuse offer. For the purpose of the analysis, we distinguish four types of recommendation: on the one hand, editorial and contributive recommendation, based either on experts or users’ judgments and opinions, and on the other hand, aggregative and personalized. The latter appear to be more and more central, based on users’ online behaviour. With the algorithmic recommendation, alleged, declared or observed users’ preferences form the material of predictive recommendation in apparatuses developed by different operators of legacy media. This step is the almost final one in a process of delinearization and individualization. However, despite its efficiency, this form of recommendation raises a number of questions. More than the risk of confinement and filter bubble, the biggest problem seems to be related to the oligopolistic power of a few players, controlling consumer behaviour data.

  14. RECOMMENDATION SYSTEM USING BLOOM FILTER IN MAPREDUCE

    Directory of Open Access Journals (Sweden)

    Reena Pagare

    2013-11-01

    Full Text Available Many clients like to use the Web to discover product details in the form of online reviews. The reviews are provided by other clients and specialists. Recommender systems provide an important response to the information overload problem as it presents users more practical and personalized information facilities. Collaborative filtering methods are vital component in recommender systems as they generate high-quality recommendations by influencing the likings of society of similar users. The collaborative filtering method has assumption that people having same tastes choose the same items. The conventional collaborative filtering system has drawbacks as sparse data problem & lack of scalability. A new recommender system is required to deal with the sparse data problem & produce high quality recommendations in large scale mobile environment. MapReduce is a programming model which is widely used for large-scale data analysis. The described algorithm of recommendation mechanism for mobile commerce is user based collaborative filtering using MapReduce which reduces scalability problem in conventional CF system. One of the essential operations for the data analysis is join operation. But MapReduce is not very competent to execute the join operation as it always uses all records in the datasets where only small fraction of datasets are applicable for the join operation. This problem can be reduced by applying bloomjoin algorithm. The bloom filters are constructed and used to filter out redundant intermediate records. The proposed algorithm using bloom filter will reduce the number of intermediate results and will improve the join performance.

  15. [Healing gardens: recommendations and criteria for design].

    Science.gov (United States)

    Rivasseau-Jonveaux, Thérèse; Pop, Alina; Fescharek, Reinhard; Chuzeville, Stanislas Bah; Jacob, Christel; Demarche, Laëtitia; Soulon, Laure; Malerba, Gabriel

    2012-09-01

    The French Alzheimer plan anticipates new specialized structures for cognitive rehabilitation and psycho-behavioural therapy of Alzheimer's patients: the cognitive-behavioural units as follow-care units, the units of reinforced hospitalization inside the long term care units and the adapted activities units. this plan indicates the need to make healing gardens integral parts of these units. The benefits of green space in urban environments has been demonstrated with regards to physical, psychological and sociological effects and similarly studies in hospitals have revealed objective and measurable improvements of patients well being. Although green spaces and gardens are available in many French care units, they are rarely specifically adapted to the needs of Alzheimer's patients. For the garden "art, memory and life" a specific concept guided by a neuropsychological approach was developed, complemented by an artistic vision based on cultural invariants. It is already used in the frame of non-pharmacological therapies to improve symptoms such as deambulation, sleep disorders, apathy and aggressive behaviors. Based on the literature, and our experience and research, recommendations for the design of such gardens dedicated to Alzheimer's patients can be proposed. Beyond taking into account obvious aspects relating to security, allowing for free access, a careful design of walk-ways and a conscious choice of plants is needed. A systematic analysis of the existing green spaces or garden must be conducted in order to pinpoint the weakness of the space and identify the potential for developing it into a real healing garden. Evaluation of adapted questionnaires for users and professionals allow to establish a list of requirements combining both user requests and therapeutic needs as basis for the design of the garden as well as to evaluate during the course of the project, whether the needs of the various stakeholders have been met or if adjustments are necessary. PMID

  16. 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 recommend...... 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.......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...

  17. 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

  18. Tour Route Recommendation Begins with Multimodal Classification

    Directory of Open Access Journals (Sweden)

    Xiujun Chen

    2012-02-01

    Full Text Available Location estimation of tourist photos by classifi­cation is challenging due to the unstable and less-discriminative features of photos taken in each city. In this paper, we originally deal with this issue in an alternative way, which begins with but is not limited to classification. We explore textual, temporal, geographic as well as visual information to make tour route recommendation. Given a query photo, we recommend a city by first classifying the photo to get scores that indicate its similarities with photos from each city, and then evaluating the attractiveness of each city by modeling its hotness potential. We do not aim at finding out where the photo was taken exactly; instead, we combine the similarity and hotness potentials according to the user’s preference and recommend the city that has the highest combination value. Then, we suggest the next city by further modeling the correlation and interaction between cities pairwise with two potentials, i.e., proximity and co-visitedness. Applying the greedy algorithm, we recommend one city at a time and eventually generate a tour route consist­ing of all the recommended cities in order. Furthermore, in order to show different visual and cultural character­istics across cities, we classify photos of each city into four categories, i.e., food, landscape, man-made and person. In experiments, we collected a database containing 41792 photos of 35 important cities along the silkroad and provided a query sample for tour route recommendation. Experimental results have shown the effectiveness and reliability of our recommendation model.

  19. Application of a rapid and selective method for the simultaneous determination of carebastine and pseudoephedrine in human plasma by liquid chromatography-electrospray mass spectrometry for bioequivalence study in Korean subjects.

    Science.gov (United States)

    Lee, Myung-Jae; Lee, Heon-Woo; Kang, Jong-Min; Seo, Ji-Hyung; Tak, Seong-Kun; Shim, Wangseob; Yim, Sung-Vin; Hong, Seung Jae; Lee, Kyung-Tae

    2010-10-01

    We describe a simple, rapid and sensitive high-performance liquid chromatography-electrospray ionization tandem mass spectrometric method that was developed for the simultaneous determination of carebastine and pseudoephedrine in human plasma using cisapride as an internal standard. Acquisition was performed in multiple-reaction monitoring mode by monitoring the transitions: m/z 500.43 > 167.09 for carebastine and m/z 166.04 > 147.88 for pseudoephedrine. The devised method involves a simple single-step liquid-liquid extraction with ethyl acetate. Chromatographic separation was performed on a C(18) reversed-phase chromatographic column at 0.2  mL/min by isocratic elution with 10  mM ammonium formate buffer-acetonitrile (30:70, v/v; adjusted to pH 3.3 with formic acid). The devised method was validated over 0.5-100  ng/mL of carebastine and 5-1000  ng/mL of pseudoephedrine with acceptable accuracy and precision, and was successfully applied to a bioequivalence study involving a single oral dose (10  mg of ebastine plus 120  mg of pseudoephedrine complex) to healthy Korean volunteers.

  20. Development, optimization and validation of a highly sensitive UPLC-ESI-MS/MS method for simultaneous quantification of amlodipine, benazeprile and benazeprilat in human plasma: application to a bioequivalence study.

    Science.gov (United States)

    Rezk, Mamdouh R; Badr, Kamal A

    2014-09-01

    A rapid, simple, sensitive and specific LC-MS/MS method has been developed and validated for the simultaneous estimation of amlodipine (AML), benazepril (BEN) and benazeprilat (BNT) using eplerenone and torsemide as internal standards (IS). The Xevo TQD LC-MS/MS was operated under the multiple-reaction monitoring mode using electrospray ionization. Sample preparation involves both extraction and precipitation techniques. The reconstituted samples were chromatographed on Acquity UPLC BEH C18 (50mm×2.1mm, 1.7μm) column by pumping 0.1% formic acid and acetonitrile in a gradient mode at a flow rate of 0.45ml/min. A detailed validation of the method was performed as per the FDA guidelines and the standard curves were found to be linear in the range of 0.1-5ng/ml for AML; 5-1200ng/ml for both BEN and BNT. The intra-day and inter-day precision and accuracy results were within the acceptable limits. A run time of 2.5min for each sample made it possible to analyze more than 300 human plasma samples per day. The developed assay method was successfully applied to a bioequivalence study in human volunteers. PMID:24863555